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{ "NCT_ID" : "NCT04198376", "Brief_Title" : "The Laterally Closed Tunnel Versus Modified Coronally Advanced Tunnel for Mandibular Anterior Gingival Recession Defects", "Official_title" : "The Laterally Closed Tunnel Versus Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft for Treatment of Deep Isolated Mandibular Anterior Gingival Recession Defects: A Randomized Controlled Clinical Trial", "Conditions" : ["Gingival Recession, Localized"], "Interventions" : ["Procedure: Group A The Laterally Closed Tunnel Technique with SCTG", "Procedure: Group B Modified Coronally Advanced Tunnel Technique with SCTG."], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-01-20", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-31", "Study_Completion_Date(Actual)" : "2021-01-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-12-12", "First_Posted(Estimated)" : 2019-12-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-12-12", "Last_Update_Posted(Estimated)" : 2022-11-04", "Last_Verified" : 2022-11" } }}

#Study Description Brief Summary The aim of this study is to comparatively evaluate the advantages of LCT with SCTG over MCAT with SCTG for coverage of deep isolated mandibular anterior recession. Detailed Description Gingival recession is defined as the displacement of the soft tissue margin apical to the cementoenamel junction.Different predisposing anatomic features can result in recession such as position and anatomy of teeth in the dental arch, bony dehiscence, thickness of the alveolar mucosa, muscle pull, orthodontic treatment, thin gingival biotype, buccal prominence of teeth, lack of keratinized tissue, high frenum attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation. It is a common finding in patient with a high standard of oral hygiene as well as in periodontally untreated populations with poor oral hygiene.The migration of the marginal tissue to an apical position may lead to esthetic concern, dentin hypersensitivity, root caries, and cervical wear. Mandibular gingival recession defects present significant therapeutic challenges such as shallow vestibular depth, high frenal attachment, thin soft tissue biotypes leading to thin coronally advanced flaps, and thin often dehisced labial bone.Due to these factors the mandibular sites suffers strong and constant tension in comparison to the maxilla, hence there is lack of predictability in the mandibular sites. Various surgical techniques have been proposed for the treatment of isolated mandibular recessions including the use of fully or partially epithelized free gingival grafts (FGG) or sub epithelial connective tissue graft in conjunction with various types of flaps eg: (envelope, coronally or laterally positioned flap, double pedicle flap (DPF) or tunnelling (TUN) alone or combined with laterally positioned pedicle flaps (LPPF). Coronally advanced flap (CAF) +connective tissue graft (CTG) is considered as the gold standard treatment in reducing or eliminating gingival recession. Tunnel technique was first introduced by Allen in 19949, and its modifications by Zabalegui in 199910, Modified Coronally Advanced Tunnel (MCAT) by Azzi et al 2002 and Microsurgical CAT by Zuhr 2007. However, in deep isolated mandibular recessions located in the anterior area, tension free coronal displacement of the flap can be extremely difficult and may result in decreased vestibular depth and flap dehiscence due to increased flap tension. Therefore a new clinical approach of The Laterally Closed Tunnel (LCT), specifically designed for deep isolated anterior Mandibular Millers class I, II and III recession has been introduced to predictably cover recession and minimize the risk for post operative complications caused by unfavourable anatomical situations. The important aspect of LCT is the wide mesiodistal and apical mobilisation of the tunnel which enables tension free lateral movement of the flap margins to cover the graft and the recession. The tension free lateral movement and the passive lateral closure of the tunnel margins maybe advantageous in the treatment of isolated deep recessions located in areas with inserting frenula or shallow vestibule, which makes a coronal tension free advancement of the flap extremely difficult. Beside the tension free flap preparation, the use of SCTG plays a key role in increasing flap thickness and blood clot stability and in providing the cells needed for soft tissue regeneration and keratinization. #Intervention - PROCEDURE : Group A The Laterally Closed Tunnel Technique with SCTG - Following the administration of local anaesthesia 2% lignocaine hydrochloride.In the LCT technique a bevelled intrasulcular incisions will be made around the necks of the affected teeth with Orban Knife.The tunnelling will be accomplished with tunneling instrument (TKN2).A mucoperiosteal tunnel will be prepared using a specially designed tunneling instrument.The muscle and collagen fibres will be released using surgical blades and gracey curettes.Subepithelial CTG will be harvested from palate using single incision technique.The graft will be removed and will be placed on saline soaked gauze and kept wet until its transfer to the recipient bed.An immediate closure of the donor site is performed using modified mattress sutures.The graft will be adapted to the CEJ by means of sling suture.Finally the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures.The surgical sites will be protected with a non eugenol periodontal dressing. - PROCEDURE : Group B Modified Coronally Advanced Tunnel Technique with SCTG. - In MCAT technique all the buccal tissues will be undermined and connected only the papillary region will be left attached.A full thickness preparation of the papillary region will be created this will be done with a small elevator.A second surgical site to obtain the subepithelial CTG using single incision technique.A support suture will be performed to guide the CTG into the recipient site.The graft will be gently pushed into the pouch with a packing instrument and by pulling the support suture.The entire gingivopapillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva.The anchorage in the lingual gingiva will be placed far apically.The suture must capture the buccal flap and graft to avail optimal stabilization.The surgical sites will be protected with a non eugenol periodontal dressing.

#Eligibility Criteria: Inclusion Criteria: * Isolated Miller's class I, II, III or combined recession defects in mandibular arch. * Age >= 18 years. * Patients with healthy or treated periodontal conditions. * Patients willing to participate in the study. * Absence of uncontrolled medical conditions. * Full mouth plaque score <= 10%(O'Leary 1972). * Full mouth bleeding score <10%(Ainamo and Bay 1975). * Patients with esthetic concerns. Exclusion Criteria: * Pregnant or lactating females. * Tobacco smoking. * Uncontrolled medical conditions. * Untreated periodontal conditions. * Use of systemic antibiotics in the past 3 months. * Patients treated with any medication known to cause gingival hyperplasia. * Drug and alcohol abuse. * No occlusal interferences. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT04198376

{ "NCT_ID" : "NCT01416246", "Brief_Title" : "Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant", "Official_title" : "Pilot Trial of Fractionated Stem Cell Infusions in Myeloma Patients Undergoing Autologous Stem Cell Transplant", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Procedure: Fractionated Stem Cell Infusions"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-04", "Study_Completion_Date(Actual)" : "2016-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-08-11", "First_Posted(Estimated)" : 2011-08-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-08-11", "Last_Update_Posted(Estimated)" : 2016-04-29", "Last_Verified" : 2016-04" } }}

#Study Description Brief Summary Multiple myeloma is difficult to treat with only anti-cancer medicine (called chemotherapy) or radiation alone. Sometimes higher doses of chemotherapy are used but when used can also lower blood counts. Using own cells (special cells called stem cells) to help increase the blood counts after high doses of chemotherapy is called autologous stem cell transplantation (ASCT). Using own stem cells to restore blood counts and other advances in supportive measures (antibiotics and growth factors that increase blood counts) has improved the safety of ASCT. However, blood counts still decrease for a period of days after high doses of chemotherapy. During that time, patients are at greater risk for infections. Studies have shown that the faster the blood counts recover after ASCT, the less at risk there is for developing unwanted side effects after ASCT. Typically during an ASCT, a patient's stem cells are given back to them all at once on a single day. In this study, the investigators plan to see what happens when smaller amounts of own stem cells are given back to the patient over multiple days. The investigators want to find out what effects good and/or bad this will have on the patient and there multiple myeloma. Some studies have shown that giving back stem cells over a period of days helps to increase bone marrow activity and decrease the time it takes for blood counts to recover after ASCT. It is our hope that this new approach may lower a patient's risk of side effects and infections, decrease the number of blood transfusions that a patient needs during this process, reduce the time a patient has to spend in the hospital, and lower overall treatment costs. #Intervention - PROCEDURE : Fractionated Stem Cell Infusions - Following enrollment patients will be treated with melphalan intravenously (IV) through a central venous catheter (CVC) over 30 minutes at 200mg/m2 or 140mg/m2 (if creatinine clearance is \< or = to 50 and/or age \> 70 years) on day -2. Following 24 hours of rest, the first dose of CD34+ stem cell will be administered on day 0 (2.5-5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg), followed by 3 additional doses of CD 34+ stem cells (1.5-2.5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg) on days +2, +4, and +6. Pegfilgrastim 6μg will be administered on day +1. Filgrastim 5μg/kg will be 12-24 hours after the 2nd-4th stem cell infusions. There will be a +/- 1 day window for the Day +2, +4, and +6 infusions to accommodate infusions that occur over the weekend or on holidays. - Other Names : - Patients will receive standard supportive care measures (including, antimicrobial prophylaxis, red blood cell and platelet transfusions and, treatment for neutropenic fever) as per institutional practices. Neutrophil, engraftment is defined as absolute neutrophil count (ANC) > or = to 500 x 10^6/L for 2, consecutive days.

#Eligibility Criteria: Inclusion Criteria: * Age >=18 and < than or = to 75 * Histologic and serologic findings, reviewed at MSKCC, confirming the diagnosis of multiple myeloma. Standard diagnostic criteria for multiple myeloma will be used, as per the International Myeloma Foundation consensus guidelines (Durie et al, 2003) . * Patients must have symptomatic multiple myeloma who have responded to prior induction or salvage chemotherapy (i.e. chemosensitive disease): * Patients who are receiving high-dose melphalan and ASCT as part of their initial therapy require at least minor response to their last line of therapy to document chemosensitive disease (Anderson et al. 2008) * Patients who are receiving high-dose melphalan and ASCT as part of salvage therapy require at least a minor response to their last line of therapy to document chemosensitive disease (Anderson et al. 2008). * There is no limit on the number of prior regimens received by the patient. * Patients must have at least 7 x 10^6 (+/- 0.5 x 10^6) CD34+ stem cells/kg frozen if he/she is being treated as part of a salvage (second) transplant strategy; patients must have 10 x 10^6 (+/- 0.5 x 10^6) CD34+ stem cells/kg frozen if ASCT is being performed as part of initial therapy. * Adequate organ function is required, defined as follows: * Serum bilirubin <= 2.0 mg/dl * AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal * Creatinine clearance > or = to 40 ml/min (24 hour urine collection or calculated*) *To be calculated by the Cockroft-Gault method: (140-Age) x Mass (kg) x [0.85 if female] (72 x Creatinine (mg/dL) * LVEF > or = to 45% by MUGA or rest ECHO * Diffusing capacity > or = to 45% (adjusted for hemoglobin) predicted by pulmonary function testing * Performance status KPS > or = to 70%. Exclusion Criteria: * Unstable angina or myocardial infarction within 4 months of initiating therapy on trial, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker * Pregnant or lactating females * Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas * Contraindication to melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim * Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01416246

{ "NCT_ID" : "NCT03537248", "Brief_Title" : "A Safety and Effectiveness Study of a New Multi-Purpose Contact Lens Care Solution", "Official_title" : "Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution", "Conditions" : ["Contact Lens Wear"], "Interventions" : ["Device: ReNu® Multiplus", "Device: ASP-57"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-04-23", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-10-30", "Study_Completion_Date(Actual)" : "2018-10-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-05-15", "First_Posted(Estimated)" : 2018-05-25" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-05-15", "Last_Update_Posted(Estimated)" : 2019-02-11", "Last_Verified" : 2018-06" } }}

#Study Description Brief Summary The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12 weeks). Detailed Description Approximately 330 subjects (660 eyes) will be enrolled in this 3 month (12 week) controlled, parallel group, masked, randomized study at approximately 15 investigative sites in the United States. Subjects will be randomized 2:1 to receive either Asepticys ASP-57 Multi-Purpose Solution or ReNu® Multiplus Contact Lens Solution (Control) respectively. Both Test and Control solution will be used with a rub care regimen. #Intervention - DEVICE : ASP-57 - an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses - Other Names : - Investigational Multi-Purpose Contact Lens Care Solution - DEVICE : ReNu® Multiplus - a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses

#Eligibility Criteria: Inclusion Criteria: * Subjects age >= 18 years on the date of informed consent. * All subjects must provide signed written consent prior to participation in any study related procedures. * Successful history of wear of the one of the following lens types (toric and multifocal lenses of the specified lens type are allowed) in both eyes during the past 3 months, and history of at least 5 consecutive days of successful daily wear in both eyes prior to Visit 1: * All Bausch & Lomb PureVision lens types * All Alcon Air Optix lens types * All CooperVision Biofinity lens types * All Vistakon Acuvue Oasys lens types * Any conventional hydrogel Group IV lens * Vision correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. * Clear central corneas and free of any anterior segment disorders * Habitual use of a Multi-Purpose Solution for cleaning, disinfecting, and storage of lenses. * Lens correction in both eyes is required and the same brand of lens is worn in each eye. * Agree to wear study lenses in both eyes on a daily wear basis, with lenses removed every night (not slept in) throughout the study period and no lens or pair of lenses worn for longer than 2 weeks. * Able and willing to comply with all care regimen and follow-up study procedures. Exclusion Criteria: * Females of childbearing potential (not surgically sterilized or postmenopausal) if any one of the following conditions are met: * currently pregnant, * plan to become pregnant during the study, * are breast-feeding. * Wear of gas permeable contact lenses within the last 30 days. * Wear of polymethylmethacrylate lenses within the last 3 months. * No topical ocular prescription medications may be administered during the study period. Ongoing use of non-preserved artificial tears up to 4 times daily (with no changes in frequency or brand) is allowed. Ongoing use of the rewetting drop the subject customarily uses (with no switch in brand or type) is also permitted during the study period. * Current systemic disease affecting ocular health or use of topical or systemic medications that, in the Investigator's opinion, could affect ocular physiology or lens performance. * Ocular astigmatism of 2.00 D or greater in either eye based on the contact lens prescription. * Grade 2 or greater finding on any slit-lamp scale and/or corneal infiltrates of any grade during slit-lamp examination at Screening. * Any finding during slit-lamp examination that, in the Investigator's opinion, interferes with contact lens wear. * Scar or neovascularization within the central 4 millimeters (mm) of the cornea. Minor peripheral corneal scarring (that does not extend into the central zone) is permitted, if in the Investigator's judgment, it does not interfere with contact lens wear. * Aphakia. * Amblyopia. * History of any corneal surgery. * Allergy to any component of the study solutions. * Participation in any clinical study within the 2 weeks prior to entry into this study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03537248

{ "NCT_ID" : "NCT04488016", "Brief_Title" : "A Study to Evaluate Relative Bioavailability, Proton Pump Inhibitor (PPI) (Rabeprazole) Effect, Food Effect and Particle Size Effect of New Acalabrutinib Tablet in Healthy Subjects", "Official_title" : "A 2-Part, Phase I, Open-label, Single-Dose, Sequential Randomized Crossover Study of New Acalabrutinib Tablet in Healthy Subjects to Evaluate Relative Bioavailability, Proton Pump Inhibitor (Rabeprazole) Effect, Food Effect and Particle Size Effect", "Conditions" : ["Bioavailability", "B-cell Lymphoid Cancer"], "Interventions" : ["Drug: Treatment C - Part 1", "Drug: Treatment A- Part 1", "Drug: Treatment A-Part 2", "Drug: Treatment C - Part 2", "Drug: Treatment B- Part 1", "Drug: Treatment D- Part 1", "Drug: Treatment D - Part 2", "Drug: Treatment B - Part 2"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "SEQUENTIAL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-06-24", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-01-20", "Study_Completion_Date(Actual)" : "2021-01-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-06-23", "First_Posted(Estimated)" : 2020-07-27" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-07-22", "Last_Update_Posted(Estimated)" : 2021-02-03", "Last_Verified" : 2021-02" } }}

#Study Description Brief Summary This study will be a 2-part, open-label, single-center relative bioavailability, PPI effect, food-effect and particle size effect randomized crossover study of acalabrutinib tablets in healthy subjects (males or females). The study will be divided in 2 study parts; following a review of the safety and Pharmacokinetics (PK) data from Part 1, the study is planned to be continued with Part 2. Detailed Description The study will be divided in 2 study parts; Part 1 of this study will be an open-label, 3-treatment-period, 4-treatment, single-center relative bioavailability, PPI effect, and food-effect randomized crossover study of a new acalabrutinib tablet in healthy subjects (males or females). The relative bioavailability part of Study Part 1 is designed to investigate the PK of the acalabrutinib tablet compared with the PK of acalabrutinib capsule, when administered as a single dose with water under the fasted condition (\>10 hours). The PPI effect part of Study Part 1 is designed to compare the PK of acalabrutinib tablet with or without coadministration of the PPI rabeprazole. The food-effect part of Study Part 1 is designed to compare the PK of acalabrutinib tablet under fed and fasted conditions. For each subject, a SmartPill will be administered with 120 mL of still water followed immediately by a single oral dose of acalabrutinib tablet (Treatment B, C or D) or acalabrutinib capsule (Treatment A) administered with 120 mL of still water. Study Part 1 will comprise: * A screening period of maximum 28 days; * Three treatment periods during which subjects will be resident from prior to the evening meal the night before dosing with Investigational medicinal product (IMP) (Day -1) until at least 48 hours after dosing; discharged on the morning of Day 3; and * A Follow-up Visit within 7 to 10 days. There will be a minimum washout period of at least 7 days between each acalabrutinib administration. A decision to continue with Study Part 2 will be made following a review of the preliminary data for relative bioavailability (acalabrutinib tablet versus acalabrutinib capsule), food effect, PPI effect, and safety observed in Part 1. Part 2 of this study will be an open-label, 4-treatment-period, 4-treatment, single-center relative bioavailability, randomized crossover study to determine the effect of particle size on the PK of a single dose of acalabrutinib tablet in healthy subjects (males or females). This relative bioavailability study is designed to investigate the PK of acalabrutinib tablets with various drug substance particle size distributions and the PK of acalabrutinib solution at a single oral dose of 100 mg under the fasted condition (\>10 hours). Study Part 2 will comprise: * A screening period of maximum 28 days; * Four treatment periods during which subjects will be resident prior to the evening meal the night before dosing with IMP (Day -1) until at least 48 hours after dosing; discharged on the morning of Day 3; and * A Follow-up Visit within 7 to 10 days. There will be a minimum washout period of at least 3 days between each acalabrutinib administration. #Intervention - DRUG : Treatment A- Part 1 - Subjects will receive 100 mg acalabrutinib capsule, fasted state; - DRUG : Treatment B- Part 1 - Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state - DRUG : Treatment C - Part 1 - Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fed state - DRUG : Treatment D- Part 1 - Subjects will receive Rabeprazole 20 mg QD (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1) and following prior administration of rabeprazole 20 mg Twice per day (BID) (with meals) on Days -3, -2 and -1. - DRUG : Treatment A-Part 2 - Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state - DRUG : Treatment B - Part 2 - Subjects will receive 100 mg acalabrutinib tablet (Variant 2), fasted state - DRUG : Treatment C - Part 2 - Subjects will receive 100 mg acalabrutinib tablet (Variant 3), fasted state - DRUG : Treatment D - Part 2 - Subjects will receive 100 mg acalabrutinib solution, (Variant 4), fasted state

#Eligibility Criteria: Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Healthy adult male or female subjects aged 18 - 55 years with suitable veins for cannulation or repeated venipuncture. * Male subject must adhere to the contraception methods. * Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening. * Have a Body mass index (BMI) between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at screening. * Understands the study procedures in the Informed Consent Form (ICF) and willing and able to comply with the protocol. * Willingness and ability to swallow study drugs, including the SmartPill. * Willingness to consume a standardized, high- calorie, high-fat FDA breakfast. Exclusion Criteria: * History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study. * History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Evidence of ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections). * Any clinically significant illness, medical/surgical procedure, or trauma within 30 days of the first administration of IMP. * Any clinically significant abnormalities in clinical chemistry, hematology, coagulation, or urinalysis results, at screening and first admission to the study unit (first treatment period) as judged by the PI, and defined as: (1) Serum Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and serum bilirubin (total and direct) > Upper limit of normal (ULN). (2) Hemoglobin < ULN. * Any clinically significant abnormal findings in vital signs at screening and first admission to the study unit (first treatment period), as judged by the PI. * Any clinically significant abnormalities on 12-lead ECG at screening and first admission to the study unit (first treatment period), as judged by the PI. * Any positive result on screening for serum hepatitis B surface antigen, hepatitis B core antibody (anti-HBc), hepatitis C antibody, and HIV antibody. * Known or suspected history of drug abuse, as judged by the PI. * Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 90 days of the first administration of IMP in this study. The period of exclusion begins 90 days after the final dose or 30 days after the last visitwhichever is the longest. * Plasma donation within 30 days of screening or any blood donation/loss more than 500 mL during the 90 days prior to screening. * History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to acalabrutinib or rabeprazole. * Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 90 days prior to screening. * Positive screen for drugs of abuse or cotinine at screening or on each admission to the study center or positive screen for alcohol on each admission to the study center. * Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP. * Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life. Hormone replacement therapy will not be allowed. * Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI. * Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the PI. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (e.g., >5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site. * Part 1 only: Inability or unwillingness to swallow SmartPill, including: Subject has any of the following contraindications for the SmartPill: * A history of gastric bezoars * Swallowing disorders * Suspected or known strictures, fistulas or physiological/mechanical GI obstruction * History of GI surgery within 90 days of administration * Severe dysphagia to food or pills * Crohn's disease or diverticulitis * Cardiac pacemakers or other implanted electromedical devices 20 Involvement of any AstraZeneca, Acerta Pharma, Parexel or study site employee or their close relatives. 21 Subjects who have previously received acalabrutinib. 22 Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements. 23 Subjects who cannot communicate reliably with the Investigator. 24 Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT04488016

{ "NCT_ID" : "NCT04760314", "Brief_Title" : "A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis", "Official_title" : "A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab When Used in Combination With Topical Corticosteroid Treatment in Japanese Patients With Moderate-to-Severe Atopic Dermatitis", "Conditions" : ["Dermatitis, Atopic", "Dermatitis", "Eczema", "Skin Diseases", "Skin Diseases, Genetic"], "Interventions" : ["Drug: Placebo", "Drug: Topical Corticosteroid", "Drug: Lebrikizumab"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-03-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-07-31", "Study_Completion_Date(Actual)" : "2023-02-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-02-10", "First_Submitted_that_Met_QC_Criteria" : 2023-07-28", "First_Posted(Estimated)" : 2021-02-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-02-17", "Last_Update_Posted(Estimated)" : 2023-08-23", "Last_Verified" : 2023-07" } }}

#Study Description Brief Summary The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in Japanese participants with atopic dermatitis. #Intervention - DRUG : Lebrikizumab - Administered SC - Other Names : - LY3650150 - DRUG : Placebo - Administered SC - DRUG : Topical Corticosteroid - Self-applied

#Eligibility Criteria: Inclusion Criteria: * Have chronic Atopic Dermatitis (AD) that has been present for >=1 year before the screening. * Have moderate-to-severe AD, including all of the following: * EASI score >=16 at the baseline * IGA score >=3 (scale of 0 to 4) at the baseline * AD involvement on >=10% of Body Surface Area (BSA) at the baseline * Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following: * Inability to achieve good disease control, defined as mild disease or better (for example, IGA <=2) after use of at least a medium-potency topical corticosteroids (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (for example, 14 days for super-potent TCS), whichever is shorter. Topical corticosteroids may be used with or without Topical calcineurin inhibitors (TCI) and/or topical Janus Kinase (JAK) inhibitors. * Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate (MTX), azathioprine, and mycophenolate mofetil (MMF), will also be considered as surrogates for having inadequate response to topical therapy. * Body weight >=40 kilogram (kg) Exclusion Criteria: * Have a history of anaphylaxis * Have uncontrolled chronic disease that might require bursts of oral corticosteroids for example, comorbid severe uncontrolled asthma within the past 12 months requiring systemic corticosteroid treatment or hospitalization for >24 hours at baseline. * Have an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline or superficial skin infections within 1 week before the baseline. * Evidence of acute or chronic hepatitis or known liver cirrhosis. * Have a history of pneumocystis pneumonia (PCP) or a positive beta-D-glucan test at screening and a confirmed diagnosis of PCP. * Have a history of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. * Have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus erythematosus) that may interfere with study assessments. * Have presence of significant uncontrolled neuropsychiatric disorder. * Have been exposed to a live vaccine within 12 weeks prior to baseline or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug. Sex : ALL Ages : - Minimum Age : 12 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT04760314

{ "NCT_ID" : "NCT00908700", "Brief_Title" : "Left Atrial Appendage Occlusion Study II", "Official_title" : "Phase III Pilot Study - Left Atrial Appendage Occlusion Study", "Conditions" : ["Atrial Fibrillation", "Stroke"], "Interventions" : ["Procedure: Surgical occlusion of the left atrial appendage", "Procedure: Best medical practice"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-11", "Study_Completion_Date(Actual)" : "2012-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-05-26", "First_Posted(Estimated)" : 2009-05-27" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-05-26", "Last_Update_Posted(Estimated)" : 2015-09-23", "Last_Verified" : 2015-09" } }}

#Study Description Brief Summary A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonary bypass with additional risk factors for late stroke. Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best medical therapy as per guidelines. Main research questions: 1. Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques? 2. In patients with atrial fibrillation with 2 or more risk factors for stroke, will removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of systemic embolic events and major bleeding compared to warfarin? Detailed Description The number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (AF) is stroke. Echocardiographic studies suggest that the predominant source of stroke in AF is the left atrial appendage (LAA). At present, there are no sufficiently powered trials to answer whether removal of the LAA can reduce the risk of systemic embolic events. LAAOS pilot study will recruit 50 participants undergoing open-heart surgery in 5 Canadian academic cardiac surgery centers. The study will inform the feasibility of conducting a large RCT and will provide information of the efficacy and safety of appendage occlusion technique. From this study we envision a a large international randomized controlled trial (LAAOS II) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery. #Intervention - PROCEDURE : Surgical occlusion of the left atrial appendage - Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device. - PROCEDURE : Best medical practice - Best medical practice for atrial fibrillation related stroke prevention as per guidelines.

#Eligibility Criteria: Inclusion Criteria: * Adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass * A history of ECG-documented atrial fibrillation with prior stroke or TIA, or at least two of the following risk factors: * age => 65 years * hypertension * diabetes mellitus, or * heart failure/left ventricular ejection fraction < 50% Exclusion Criteria: * Patients in whom surgical AF ablation (MAZE or otherwise) is planned * Planned 'off-pump' surgery * Planned implantation of a mechanical valve * Heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00908700

{ "NCT_ID" : "NCT02679469", "Brief_Title" : "A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects", "Conditions" : ["Alcohol Dependence"], "Interventions" : ["Drug: nalmefene hydrochloride 10 mg"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-03", "Study_Completion_Date(Actual)" : "2016-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-01-25", "First_Submitted_that_Met_QC_Criteria" : 2017-04-17", "First_Posted(Estimated)" : 2016-02-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-02-09", "Last_Update_Posted(Estimated)" : 2017-04-18", "Last_Verified" : 2017-04" } }}

#Study Description Brief Summary The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated. #Intervention - DRUG : nalmefene hydrochloride 10 mg

#Eligibility Criteria: Inclusion Criteria: * The subject is a Japanese male. * The subject is able to read and understand the informed consent form (ICF). * The subject has a body mass index (BMI) >= 19 kg/m2 and <= 25 kg/m2 at the screening visit. * The subject has a resting pulse and heart rate (as read on the ECG) >= 45 bpm and <= 100 bpm at the screening visit. Exclusion Criteria: * The subject has taken any prescription drugs, over-the counter medications, vitamin supplements, or supplements containing St. John's Wort (Hypericum perforatum) within 2 weeks prior to Day 1. * The subject has a significant history of alcohol abuse, defined as an alcohol intake greater than 21 units per week. (A unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits.) * The subject has taken any investigational products within 4 months prior to Day 1. Sex : MALE Ages : - Minimum Age : 20 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02679469

{ "NCT_ID" : "NCT00537368", "Brief_Title" : "First Study of the Safety of CNTO 888 in Patients With Solid Tumors", "Official_title" : "A Phase 1 Study of CNTO 888, a Human Monoclonal Antibody Against CC-Chemokine Ligand 2 in Subjects With Solid Tumors", "Conditions" : ["Cancer"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-09", "Study_Completion_Date(Actual)" : "2010-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-09-28", "First_Posted(Estimated)" : 2007-10-01" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2007-09-28", "Last_Update_Posted(Estimated)" : 2010-10-22", "Last_Verified" : 2010-10" } }}

#Study Description Brief Summary The purpose of this study is to determine if CNTO 888 is safe and to determine how long CNTO 888 stays in the body and what effects it might have on cancer tumors. Detailed Description CNTO 888 is a monoclonal antibody. Antibodies are substances in the body that are involved in many biological processes. CNTO 888 is thought to work by blocking a protein called CC-Chemokine Ligand 2 (CCL2). In research studies CCL2 has been shown to increase the growth of new blood vessels which help the tumor to survive. When new blood vessels do not grow, tumors cannot get the food or oxygen they need to grow. Blocking CCL2 may help fight disease.This study consists of two parts, Part A and Part B. In Part A, five different groups of patients will be treated with five different, increasing dose levels of CNTO 888. In Part B, two of the dose levels of CNTO 888 will be tested further in different treatment schedules. CNTO 888 is given by intravenous (into the vein) infusion. Between 1 and 30 patients with advanced cancer will take part in Part A of the study. Between 24 and 33 patients with advanced cancer will take part in Part B of the study.There are three phases in part A of the study. Screening phase, which may last up to 4 weeks. Treatment phase, which may last up to 8 weeks (4 treatments) and can be extended for an extra 9 weeks (4 extra treatments) in case the patient's tumor is not getting bigger. The total treatment period could be up to 17 weeks. Follow up phase will include an end of treatment visit 4 weeks after the last infusion of CNTO 888, visits through week 18 after last infusion as well as long term collection of follow up data. After Part A is completed, up to two doses will be selected for evaluation in part B. In Part B, patients will be placed into one of 3 study groups. There are three phases in Part B of this study. The screening phase, which may last up to 4 weeks. The treatment phase, which may last up to 9 weeks (4 treatments). If the patient's tumor is not getting bigger, the patient's treatment phase may be extended up to 12 weeks (4 treatments). The total treatment period could be up to 21 weeks. The follow up phase will include an end of treatment visit 4 weeks after the last infusion of CNTO 888, visits through week 18 after last infusion as well as long-term collection of follow up data. Safety and effectiveness evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and collection of information about the occurrence and severity of adverse events. In Part A of this study, patients will receive either 0.3 , 1.0, 3.0, 10, or 15 mg/kg CNTO 888. The time between the first and second infusion is 4 weeks, with all of the following infusions will be given 2 weeks apart. Patients eligible for Part B will be assigned to either the lower dose selected from Part A, given every 2 weeks or the higher dose selected from Part A given either every 2 weeks or every 3 weeks. All patients may be in the study for 18 weeks after their last infusion. #Intervention - DRUG : CNTO 888

#Eligibility Criteria: Inclusion Criteria: * Patients with solid tumors that have progressed on or after all available standard therapy * Histological or cytological documentation of specific tumor type * Evidence of measurable or evaluable metastatic disease * Anticipated life expectancy is >= 12 weeks Exclusion Criteria: * Treatment with systemic cancer therapy or local radiotherapy within 4 weeks * Received any investigational drug/agent within 4 weeks * Major surgery within 4 weeks of first dose of study agent * Serious concurrent illness (medical or psychiatric), altered mental status (eg, dementia) or any uncontrolled medical condition (eg, uncontrolled diabetes). Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00537368

{ "NCT_ID" : "NCT03591003", "Brief_Title" : ""Persistence of Neutralizing Antibodies Against Yellow Fever (YF) in HIV-infected Patients"", "Official_title" : ""Persistence of Neutralizing Antibodies After Immunization Against Yellow Fever (YF) in HIV-infected Patients: a Multicenter Study"", "Conditions" : ["HIV Infections", "Yellow Fever Vaccine"], "Interventions" : ["Diagnostic Test: Yellow fever neutralizing antibodies measure"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-01", "Study_Completion_Date(Actual)" : "2023-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-06-19", "First_Posted(Estimated)" : 2018-07-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-07-17", "Last_Update_Posted(Estimated)" : 2025-01-07", "Last_Verified" : 2025-01" } }}

#Study Description Brief Summary Participating countries: Belgium Context: In June 2013, WHO notified that 'a single dose of YF vaccine is sufficient to confer sustained life-long protective immunity against YF disease and that a booster dose is not necessary'. . For HIV infected persons the recommendation was less stringent and the position paper concluded that hiv infected persons may 'hypothetically, benefit from a second dose or booster dose '.1 Recently, WHO changed the recommendations about a booster dose of YF vaccine, based on the fact that serum neutralizing antibodies against YF are still at detectable levels after 20-35 years and probably lifelong in immunocompetent patients. Unfortunately, data on persistence of Neutralizing antibodies Titers (NT) in immunocompromised patients are missing and only few studies reported data about HIV-infected patients. Additional data are needed. Primary objective: To assess presence / persistence of Neutralizing Titers (NT) of antibodies after YF immunization in HIV-infected patients. Secondary objectives: 1. To identify risk factors for early and late waning of NT after YF immunization 2. To modelize kinetics of NT after YF immunization in different subpopulations of HIV patients, including population of young HIV patients infected vertically 3. To identify risk factors for absence of seroconversion in the year after YF immunization 4. To compare persistence of NT in HIV patients infected vertically or not vertically 5. To quantify seroconversion rate after YF vaccination Methodology / study design This study is a single arm, non randomized, cross-sectional, multicenter study in AIDS Reference Centers from Belgium. The maximum duration of the study for each patient will be 1 visit, consisting of: * the screening and inclusion visit (single visit V1) to check the patient eligibility, sign informed consent, perform the biologic tests necessary for the study and answer the questionnaire * whenever possible, an additional serum / plasma sample coming from serabank / plasmabank will be identified for each patient. This sample must have been taken during the year following YF immunization. * data about patient's HIV history has to be extracted from the HIV database or from patients' file Estimated enrolment 750 patients + 30 patients infected vertically with HIV Primary outcome Number of HIV patients with protective YF NT ≥ 1:10 at different timepoints after YF immunization Secondary outcomes 1. Number of patients with protective YF NT ≥ 1:10 in the year following YF immunization 2. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) for absence of seroconversion in the year following YF immunization 3. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of early waning (before 10 years) of YF NT 4. Risk factors (demographics and immunovirological parameters, antiretroviral treatment) of late waning (after 10 years) of YF NT Eligibility Inclusion criteria 1. Infection with HIV-1 (vertical transmission or not) 2. Immunization with at least one injection of YF vaccine (Stamaril®,17D strain Rockefeller, Sanofi Pasteur) with proof of vaccine administration 3. Informed consent signed prior to any study procedure Exclusion criteria Inability to give informed consent Substudies * Whenever possible, an additional sera or plasma sample from the year following YF vaccine will be selected and analyzed to assess early seroconversion rate * Whenever possible, an additional sera or plasma sample from the year before YF vaccine will be selected and analyzed to assess seroconversion rate * In CHU Saint-Pierre, an additional cohort of patients infected vertically with HIV will be selected and will participate to the study Detailed Description This study is a multicenter and cross sectional study performed in several ARC (AIDS Reference Centers) in Belgium and coordinated by CHU Saint-Pierre (Brussels, Belgium). There is two parts in the study: a prospective part and a retrospective part. There is no control group in this study. Prospective study Sera / plasma samples of HIV patients immunized with at least one injection of YF vaccine (Stamaril® ,17D strain Rockefeller, Sanofi Pasteur) will be collected prospectively during the patient's single Visit. Analysis of samples will assess persistence of neutralizing antibodies titers (NT) against YF. Retrospective study Whenever possible, serum or plasma sample will also be collected retrospectively (from a serum/plasma bank). Retrospective collection of samples must identify at least one sample per patient taken during the year before YF vaccine and from 30 days to 12 months following YF immunization The retrospective study has three study timepoints : Baseline is defined as an available sample during the period 12 months to day 0 before YF vaccination. Timepoint one is defined as a sample between one month and one year after YF. In case of several samples, the sample nearest to one month will be chosen. Time point two is defined as the last available sample. In case the patient would have been re-vaccinated in the meantime (eg for interval higher than ten years; identied as DateVaccine2), the last sample before revaccination will be chosen. Objectives of the retrospective study 1. To assess seroconversion rate during the year following YF immunization 2. To identify risk factors (demographics and immunovirological parameters, antiretroviral treatment ) for not seroconverting after primary vaccination with YF vaccine Description of the retrospective study Blood samples from HIV patients are kept, often for several years, in a sample bank. Depending of YF date of immunization, samples from the year before and following YF immunization will be identified and analysed. The PRNT technique will be used to assess presence of YF neutralizing antibodies (Serum or Plasma). Samples will be centralized in CHU Saint-Pierre after one and two years of study. Assessment of presence of neutralizing antibodies titers (NT) against YF will be performed by PRNT (Plaque Reduction Neutralizing Test), which is the current gold standard technique. After, the samples will be sent to France (Laboratory Cerba, Saint-Ouen l'Aumône) or in Germany (Berlin) to be analyzed. The surplus of your samples will be destroyed once the analyses described in this document have been carried out, i.e. in principle in maximum 10 years. At least one sample will be analysed for each patient. A NT ≥ 1:10 will be considered as protective against natural YF. Data that will be collected include demographics, date of HIV diagnosis, nadir CD4 and date, % CD4, CD38/CD8 (if available), CD4 and CD8 count at time of immunization against YF and at time of serological analysis, ARV therapy at time of immunization against YF and at time of serological analysis, plasma HIV RNA at time of immunization against YF and at time of serological analysis, number of YF vaccines, number of months with potential exposure to YF. Data will be collected by questionnaire and collected by local investigator, for instance by extraction from an HIV database. A CRF will then be completed by local investigators and sent to the data manager in CHU Saint-Pierre. Vertical transmission substudy The same design is applied to this substudy. The population study is a population of HIV patients infected vertically, selected in only CHU Saint-Pierre. Laboratory techniques: Serological analysis will be performed at Centre for Biological Threats and Special Pathogens in Berlin, using a plaque reduction neutralization test (PRNT). This technique measures the neutralizing titers (NT: the highest serum dilution able to induce an 80% plaque reduction in cells infected by the YF17D strain). An YF virus NT ≥ 1:10 is accepted as a serologic surrogate marker of clinical protection against natural Yellow Fever. Sampling and data collection: Serological analysis will be performed on freezed sera/plasma samples (available from a serum/plasma bank retrospectively) or on fresh sera samples collected prospectively from HIV patients followed in different Belgian ARC. Samples will be centralized every year in CHU Saint-Pierre, Brussels. Serological analysis will be performed at one timepoint for each patient after YF immunization to assess persistence of NT. When possible, it must also be performed on a freezed sample from the year before and following YF vaccine. The following data will be collected, for instance extracted from HIV database of ARC: age, gender, mode of HIV contamination, ethnic origin, date of diagnosis of HIV, CD4 count nadir and date of nadir, history of AIDS, CD38/CD8 (if available), %CD4, CD4 and CD8 count, plasma HIV RNA at time of immunization against YF and at time of serological analysis, treatment for HIV at time of immunization against YF and at time of serological analysis, date of start of antiretroviral therapy. Date(s) of YF immunization(s) will be checked with help of International Certificate of Immunization for Yellow Fever of every patient or with a medical note from Travel Clinic. Potential natural YF exposure will be collected by patient questionnaire. All these data have to be included in the CRF completed by local investigator(s) then sent to the data manager in CHU Saint-Pierre. The duration of the study for each patient is one single visit, consisting of the screening and inclusion visit (visit V1) to check the patient eligibility and to perform the biologic tests and exams necessary for the study. #Intervention - DIAGNOSTIC_TEST : Yellow fever neutralizing antibodies measure - Yellow fever neutralizing antibodies measure before vaccination, within the year after vaccination and at any delay after vaccination

#Eligibility Criteria: Inclusion Criteria: * Infection with HIV-1 (vertically infected or not) * Immunization with at least one injection of YF vaccine (Stamaril®,17D strain Rockefeller, Sanofi Pasteur) with proof of immunization * Informed consent signed prior to any study procedure (for the Prospective part of the study ) Exclusion Criteria: * Inability to give informed consent or incapacitation (for the Prospective part of the study) Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03591003

{ "NCT_ID" : "NCT04347044", "Brief_Title" : "The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success", "Official_title" : "The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success", "Conditions" : ["Emphysema", "Pulmonary Rehabilitation", "Bronchoscopic Lung Volume Reduction"], "Interventions" : ["Other: Pulmonary Rehabilitation", "Other: Standart care"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-08-18", "Study_Completion_Date(Actual)" : "2020-08-18}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-04-13", "First_Posted(Estimated)" : 2020-04-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-04-13", "Last_Update_Posted(Estimated)" : 2020-08-19", "Last_Verified" : 2020-04" } }}

#Study Description Brief Summary The data of patients undergoing bronchoscopic volume reduction procedure will be analyzed retrospectively. Patients will be divided into two groups as patients with and without Pulmonary Rehabilitation before the procedure, and changes in functional levels of patients will be compared. Detailed Description The data of patients who underwent bronchoscopic volume reduction between January 2013 and March 2019 will be examined. Patients will be divided into two groups as pulmonary rehabilitation applied (PR group) and not applied (Control group) before the procedure. Changes in the parameters of initial and rehabilitation follow-up will be examined. #Intervention - OTHER : Pulmonary Rehabilitation - Exercise training+ Optimal medication and clinical follow-up - OTHER : Standart care - Optimal medication and clinical follow-up

#Eligibility Criteria: Inclusion Criteria: * Between the ages of 18 <= age <= 75 * Patients with a diagnosis of emphysema and bronchoscopic procedures Exclusion Criteria: * Patients who develop complications related to the procedure after bronchoscopic procedure. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04347044

{ "NCT_ID" : "NCT05797675", "Brief_Title" : "Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift", "Official_title" : "Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift : A Randomized Control Trial.", "Conditions" : ["Oral Sinus"], "Interventions" : ["Procedure: prf + osseodensification"], "Location_Countries" : ["Palestinian Territory, occupied"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-07-20", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-11-20", "Study_Completion_Date(Actual)" : "2022-12-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-03-22", "First_Posted(Estimated)" : 2023-04-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-03-22", "Last_Update_Posted(Estimated)" : 2023-04-11", "Last_Verified" : 2023-04" } }}

#Study Description Brief Summary 12 patients with indirect sinus lift will be selected with RBH\&gt;5mm , surgical procedure =osseodensification + Prf+ implant . 1. versah drilling system (osseodensefication technique )will be used , moreover Prf will be prepared by Blood collected in PRF tubes from patients then centrifuge (1300rpm ,14min ) . 2. primary stability will be measured using Resonance Frequency Analysis by Osstellimmediately and after 6 Mn . 3. CBCT will be taken before surgery , perioapical x-ray immediately after surgery and CBCT at 6m follow up to be apple to see the differences regarding bone quality and volume. #Intervention - PROCEDURE : prf + osseodensification - prf+ osseodensification in close sinus lift - Other Names : - platelet concentrates,

#Eligibility Criteria: Inclusion Criteria: * medically fit non pregnant no sinus pathology Exclusion Criteria: * young patients under 18 * sinus pathology Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT05797675

{ "NCT_ID" : "NCT01316419", "Brief_Title" : "Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension", "Official_title" : "An Observational Study to Evaluate the Effects of Twynsta Tablets (Telmisartan and Amlodipine FDC, q.d.) With Life Style Modifications on Blood Pressure, Quality of Life, and Other Risk Factors in Korean Patients With Hypertension", "Conditions" : ["Hypertension"], "Interventions" : ["Drug: Telmisartan", "Drug: amlodipine"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-06", "Study_Completion_Date(Actual)" : "2014-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-03-15", "First_Submitted_that_Met_QC_Criteria" : 2015-06-26", "First_Posted(Estimated)" : 2011-03-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-03-15", "Last_Update_Posted(Estimated)" : 2015-09-21", "Last_Verified" : 2015-09" } }}

#Study Description Brief Summary This observational study is designed to evaluate the effects of Twynsta tablets with life style modifications on blood pressure, quality of life, and other risk factors in Korean patients with hypertension in a routine clinical practice setting. Detailed Description Study Design: #Intervention - DRUG : Telmisartan - Telmisartan 40mg or 80mg - DRUG : amlodipine - amlodipine 5mg or 10mg

#Eligibility Criteria: Inclusion criteria: * Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or telmisartan monotherapy (=140/90 mmHg, = 130/80 mmHg for those with diabetes or kidney disease) * Age = 19 years at enrollment * Male or female patient (or legally acceptable representative) willing and able to provide written informed consent Exclusion criteria: * Patients with previous exposure to Twynsta * Patients with hypersensitivity to the active substances, or to dihydropyridine derivatives * Female patients at second and third trimesters of pregnancy * Female patients with lactation * Patients with biliary obstructive disorders * Patients with severe hepatic impairment * Patients with high grade aortic stenosis * Patients with shock * Patients with hereditary conditions such as intolerance with excipient of the products * Current participation in other clinical trials or observational studies Sex : ALL Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01316419

{ "NCT_ID" : "NCT01471093", "Brief_Title" : "Safety Study of OPC-12759 Ophthalmic Solution", "Official_title" : "Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects", "Conditions" : ["Dry Eye Syndromes"], "Interventions" : ["Drug: OPC-12759 Ophthalmic suspension", "Drug: OPC-12759 Ophthalmic solution"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-12", "Study_Completion_Date(Actual)" : "2012-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-11-03", "First_Submitted_that_Met_QC_Criteria" : 2021-06-03", "First_Posted(Estimated)" : 2011-11-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-11-09", "Last_Update_Posted(Estimated)" : 2021-06-29", "Last_Verified" : 2021-06" } }}

#Study Description Brief Summary The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects. #Intervention - DRUG : OPC-12759 Ophthalmic solution - 2％ OPC-12759 Ophthalmic solution - DRUG : OPC-12759 Ophthalmic suspension - 2％ OPC-12759 Ophthalmic suspension

#Eligibility Criteria: Inclusion Criteria: * BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2 Exclusion Criteria: * Presence of ocular disorder * Intraocular pressure of 21mmHg or higher * Corrected visual acuity of less than 1.0 * Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow * History of refractive surgery * History of other ocular surgeries within 12 months * Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose Sex : ALL Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01471093

{ "NCT_ID" : "NCT00912535", "Brief_Title" : "Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Co-morbid Anxiety Symptoms", "Official_title" : "Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Comorbid Anxiety Symptoms", "Conditions" : ["Primary Anxiety Disorders", "Mood Disorders With Comorbid Anxiety Symptoms"], "Interventions" : ["Drug: Placebo", "Drug: Quetiapine extended release tablet"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-07", "Study_Completion_Date(Actual)" : "2010-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-05-24", "First_Posted(Estimated)" : 2009-06-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-05-31", "Last_Update_Posted(Estimated)" : 2012-01-05", "Last_Verified" : 2012-01" } }}

#Study Description Brief Summary The objectives of this study are to evaluate the efficacy and safety of quetiapine extended release tablet versus placebo as adjunct to selective serotonin reuptake inhibitors/serotonin/norepinephrine reuptake inhibitors (SSRI/SNRI) in the augmentation treatment of patient with primary anxiety disorders or mood disorders with co-morbid anxiety symptoms. #Intervention - DRUG : Quetiapine extended release tablet - Quetiapine extended release tablet of 50-300mg/day - DRUG : Placebo - Placebo orally, as adjunct to the same antidepressant at the same dose.

#Eligibility Criteria: Inclusion Criteria: * Provision of written informed consent * A diagnosis of primary anxiety disorder or mood disorder with co-morbid anxiety symptoms by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) * A 14-item Hamilton Anxiety Scale (HAM-A)>= 14 * Subject have received single antidepressant at a therapeutic dose for at least 6 weeks * Male or female aged 18 <= age <= 65 years * Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment * Able to understand and comply with the requirements of the study and sign informed consent Exclusion Criteria: * Pregnancy or lactation * Any DSM-IV Axis I disorder not defined in the inclusion criteria. * Receiving any anti-psychotic 7 days prior to entering the study * Patients who, in the opinion of the investigator, post an imminent risk of suicide or a danger to self or others * Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator * Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir * Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St.John's Wort, and glucocorticoids * Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization * Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria * Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment * Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment * Unstable or inadequately treated medical illness (e.g. congestive heart failures, angina pectoris, hypertension) as judged by the investigator * Involvement in the planning and conduct of the study * Previous enrollment or randomization of treatment in the present study * Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements * A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: * Unstable DM defined as enrollment glycosylated hemoglobin(HbA1c)> 8.5% * Admitted to hospital for treatment of DM or DM related illness in past 12 weeks. * Not under physician care for DM * Physician responsible for patient's DM care has not indicated that patient's DM is controlled * Physician responsible for patient's DM care has not approved patient's participation in the study * Has not been on the same dose of oral hypoglycaemic drug(S) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones(glitazones) this period should not be less than 8 weeks * Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks * An absolute neutrophil count (ANC) of <= 1.5x10(9) per liter Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00912535

{ "NCT_ID" : "NCT06154928", "Brief_Title" : "Effects of Warm Water on GI System in Laparoscopic Cholecystectomy Patients", "Official_title" : "Investigation of the Effect of Drinking Warm Water on the Gastrointestinal System Functions of Patients Undergoing Laparoscopic Cholecystectomy", "Conditions" : ["Laparoscopic Cholecystectomy", "Abdominal Distention"], "Interventions" : ["Other: Drinking Warm Water Intervention"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-04-01", "Study_Completion_Date(Actual)" : "2021-08-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-03-22", "First_Posted(Estimated)" : 2023-12-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-11-23", "Last_Update_Posted(Estimated)" : 2023-12-04", "Last_Verified" : 2023-11" } }}

#Study Description Brief Summary Objective: The study was carried out to determine the effect of drinking warm water on GIS functions in patients who underwent laparoscopic cholecystectomy surgery. Detailed Description Method: The research was completed in Kahramanmaraş Necip Fazıl City Hospital with 100 patients, 50 of whom were in the Study Group (WG) and 50 were in the Control Group (KG). The patients in CG were given warm water to drink at the 2nd hour after surgery. On the other hand, patients in KG were allowed to drink warm water after bowel sounds started and gas was produced. Patients in both groups were 2,4,8,12 after surgery. hours were evaluated in terms of GIS functions. Statistical analysis was done in SPSS 22.0 for Windows package program. A p\<0.05 value was accepted for statistical significance. #Intervention - OTHER : Drinking Warm Water Intervention - Patients in the Warm Water Group (WG) received a warm water drinking intervention post-laparoscopic cholecystectomy. Before intake, the bed head was elevated to 45°C, and gagging and swallowing reflexes were assessed using an Abeslang to touch the oropharynx. Nausea indicated a positive reflex. Two patients with negative reflexes were excluded from WG. To maintain water temperature, individual insulated cups with thermal features were used, preventing infection transmission. Water was boiled in a clinic kettle, cooled to 37-38°C, and given to patients to drink within 15 minutes. Swallowing ability was monitored after the first sip; successful swallowing allowed the patient to continue. Patients were observed for 15 minutes with an aspirator on standby for aspiration risks. No complications occurred during the water drinking process in WG.

#Eligibility Criteria: Inclusion Criteria: * > 18 years * having surgery Exclusion Criteria: * not meeting the sampling criteria * Refused to participate Canceled surgery Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT06154928

{ "NCT_ID" : "NCT00881790", "Brief_Title" : "The Behaviour of Dental Nurses Applying Fluoride Varnish to Young Children", "Official_title" : "The Behavioural Engagement of Dental Nurses Applying the Fluoride Varnish to Young Children: the BEHAVE Study", "Conditions" : ["Dental Caries"], "Interventions" : ["Other: Fluoride varnish"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-06", "Study_Completion_Date(Actual)" : "2011-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-04-14", "First_Posted(Estimated)" : 2009-04-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-04-14", "Last_Update_Posted(Estimated)" : 2013-01-10", "Last_Verified" : 2013-01" } }}

#Study Description Brief Summary The behaviour of 12 dental nurses seeing 600 nursery school children in East Scotland will be video-taped to determine the interaction patterns adopted by the staff in the application of a fluoride varnish to the surfaces of the child's teeth. The aim is to test the benefit of certain communication strategies used by the nurses to affect an efficient application controlling for nursery school site, age of child and experience of dental nurse. Detailed Description A preliminary study has shown the following: 1. Ethical permission for this work is attainable from a Research Ethics Committee. 2. Parents are willing to give consent to their children participating in the study. 3. Dental nurses are willing to give consent for their behaviours to be video recorded within their work settings. 4. Video recordings are feasible with nursery school children, EDDNs and parents present at a nursery school setting. 5. The technical difficulties of collecting audio-visual materials from nursery school settings (e.g., camera placement, storage of video data in the field setting) and anonymising the video data using a specialist masking software can be overcome. 6. Importing video files into the Observer XT coding software is successful. 7. Development of a coding system for nurse-child interaction involving a clinical procedure has been achieved (see Appendix 1 for a brief version of the coding scheme). We have collected video recordings of more than 50 varnish application sessions in the pilot study of separate children and 6 nurses in three nursery schools. The pilot study has therefore successfully demonstrated the feasibility of collecting high quality data suitable for intensive analysis to improve our understanding of some of the processes involved in the fluoride varnish application in nursery school settings. One of the most interesting findings from the pilot study was that the permission-seeking statements used by EDDNs were negatively correlated with the treatment outcome. Summary of next phase of study: * To confirm the suitability of the preliminary coding scheme and to potentially refine and improve the coding scheme using a larger set of observational data collected in nursery school settings across three NHS Health Board regions. * Further investigation to assess the generalisability of pilot study findings by collecting a larger set of observations of children systematically across a wider set of nurse pairings (with various levels of experience) and children (of different age groups: 3yrs vs 4 yrs) and with or without previous receipt of fluoride varnish application in the Childsmile programme. * To identify the key features of the nurse-child interaction that can be used to predict a full completion of the fluoride application and to test the hypothesis that frequent targeted reinforcement is effective. * To explore effects of some additional factors in relation to the relevant participants (e.g., EDDN's level of experience, child's previous dental experience) and some situational factors (e.g., general purpose room or specialist accommodation) on the treatment outcome. * To develop additional training sessions for EDDNs using the findings of the study to improve the Childsmile programme and to increase acceptability of the varnish application. Methods Ethics proposal preparation We obtained ethics approval for the pilot study. We have successfully addressed and dealt with the ethical issues that arose from the study in the pilot stage. We have experienced no degree of difficulty in consenting staff or children for recruitment of the pilot. We believe that obtaining further ethical approval for an extended study should be achievable due to our previous experience. The difference between the pilot and this main study is an extension in the numbers of child observations. This will require a multisite ethics proposal to be entered into IRAS. In terms of ethical approval from NHS Research and Development (R \& D) offices, we are working with the NHS Research Scotland (NRS), who will assist in obtaining the approvals from different NHS R \& D offices. We have been welcomed into the setting by the nursing staff and have had no adverse effects in our work in the schools collecting the 50+ child observations. In the main study, we will collect approximately 500 child observations across several NHS Health Board regions. We will continue a positive working relation with EDDNs and nursery school staff developed in the pilot stage. We will be very careful in the consenting and recruitment of nurse and child participants without causing pressure for participation. Anonymity of personal details and confidentiality of the information provided by participants will be dealt with carefully by assigning a unique code to each of the participants and only the research team members will have access to the codes. We do not foresee any additional new factors that will jeopardise approval of an application to REC. Sample All EDDNs who have been trained in the Childsmile programme and participated in the delivery of the varnish application at nursery school settings in the three NHS Health Board regions (Tayside, Fife and Forth Valley) are identified as potential staff participants. All newly trained EDDNs who will be delivering the varnish application to nursery school children at the three regions are also included. All nursery school children in the three regions mentioned above whose parents have consented to the Childsmile varnish application programme are identified as potential child participants. The parents of those children are potential parent participants. Setting up the recording and coding system The Observer system consists of a powerful suite of programmes that integrates the input of digital video files and sound to a platform on the computer screen for repeated playback and real-time coding, diagrammatic display, simple categorical analysis and more complex sequential analysis. Various options are available for collection of the recordings and these may vary according to setting. Variables to determine the optimum system include: obtrusiveness of the camera and microphone, quality of video image required, and ease of use in the 'field'. The pilot study has shown that the materials collected from the 'field' can be transferred onto a university computer hard disc to be ready for coding purpose. The picture quality and positioning of the camera can be varied to optimise the study of the nurse-child interaction during the varnish application. Pilot observations In order to check the feasibility of the new recording system to be used in the main study (a digital DVD camera instead of a web camera in the pilot stage), we will need to make a small number of pilot observations of the nurse-child interactions. This process is important to ensure that the recorded video data can be successfully digitalized and subsequently transferred into the Observer XT8.0 for coding and analysis. Although we have had some experience of dealing with this process in the pilot stage, taking additional pilot observations is still an important step as we are using a new recording system and an updated version of the Observer XT software in the main study. These pilot observations will be also used to double check that the coding scheme developed from the pilot data is functioning properly for a new set of data. Preparation of coding scheme The preparation of a coding scheme is a vital component of the study and will require considerable effort and thought to develop a suitable system that is not too cumbersome but also detailed enough to illustrate the various strategies that are adopted by the 'actors' to progress the intervention. Of particular interest are the cases where there is unexpected behaviour or events that require inclusion in the profiling of the interaction. For example the child may refuse certain aspects of the varnish procedure and require coaxing through reassurance or distraction. Interruptions of the procedure by outside events, e.g. parental or nursery nurse involvement, fire alarms can all be present in the scheme and included or ignored in subsequent analysis. The Observer XT system enables the accurate collection of codes from video. The advantage of the updated version of the Observer XT system is the modification of the coding scheme during the coding procedure itself. Previous versions of the software did not allow this 'luxury'. Other available ('freeware') coding systems do not have this capability. Therefore, the coding scheme developed from the pilot data can be tested for fit using new datasets collected in the main study and the coding scheme can also be potentially improved if certain behaviours need to be included and/or modified. Collection of observational data Observations of nurse-child interaction will be recorded in the field using a digital DVD camera. The video observation data, initially stored on a DVD, will be transferred in digital format and then stored on a computer internal hard drive for coding and analysis. The Observer XT system is more stable if digital video data is read directly from a computer than from an external hard disc (e.g., DVD), the process of digitalizing video files and storing in a computer is, therefore, an important step for successful behaviour coding and data analysis. Each of the initial raw video files stored on DVDs will be assigned a unique code for data protection purpose and will be locked in a secure place. All digitalized video files stored on a computer internal hard disc will be permanently removed from the computer once coding and analysis is complete. These digitalized video files will then be exported onto an external hard drive that will have all data encrypted and access to data files password protected. An audit record will be compiled to allow inspection of the progress of video data files from video DVD to computer hard disc for coding and then exporting to external media for safe long-term storage. Audit will be monitored by the School Ethics Committee on a 6-month basis. Coding of video data The research assistants will be responsible for the coding of the video data. This task is labour- intensive and highly skilled. There will be approximately 500 video clips to be processed, which will require a period of about 9-10 months to complete. So far, no specific coding schemes have been developed for this type of nurse-child interactive behaviours. The new coding scheme (Appendix 1) that we have devised from the pilot study consists of about 40 codes and we have just recently conducted a reliability analysis of the scheme. There was 86% agreement using a tolerance window of 2 seconds for coded events. The kappa statistic was 0.84 (p\<.001). Reliability testing The Observer XT has appropriate reliability (kappa) statistical routines built into the software to provide estimates of agreement controlled for random chance. See 'Coding of video data' above for reliability estimate for the coding scheme. Analysis of data Video data The main software used for coding and analysing video data is the Observer XT 8.0. The rationale of the coding and analysis with The Observer system will be two-folded, a descriptive element. After all verbal and non-verbal behaviours of both nurse and child have been coded according to the coding scheme, the coded behaviours along with the time point when the behaviour took place (if the behaviour is coded as an event) or the duration of the time (if coded as a state behaviour) will be stored as a log file for one particular nurse-child interaction. Frequencies of certain behaviours can then be calculated, for example, nurse's use of praise or fantasy statements; and whether the use of these statements is linked with positive application outcome. Second, there will be an explanatory element. Sequential analysis will be employed to explore which behaviours tend to facilitate or impede the occurrence of other behaviours. The purpose of this type of analysis is to understand more complex behavioural relationships in terms of how nurses use motivational strategies to encourage cooperative behaviours of children in receiving the varnish application. #Intervention - OTHER : Fluoride varnish - the topical application of fluoride varnish to all surfaces of exposed teeth - Other Names : - Duraphat

#Eligibility Criteria: Inclusion Criteria: * children attending nursery schools (to be designated in the Health Boards described above) Exclusion Criteria: * consent of parent not supplied * learning difficulties * child refuses Sex : ALL Ages : - Minimum Age : 3 Years - Maximum Age : 6 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes

NCT00881790

{ "NCT_ID" : "NCT02016183", "Brief_Title" : "Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)", "Official_title" : "ECARD Combination Tablets LD&HD Special Drug Use Surveillance: Long-term Use (12 Months)", "Conditions" : ["Hypertension"], "Interventions" : ["Drug: Candesartan cilexetil / hydrochlorothiazide"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-04-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-09-30", "Study_Completion_Date(Actual)" : "2012-09-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-12-14", "First_Submitted_that_Met_QC_Criteria" : 2018-04-17", "First_Posted(Estimated)" : 2013-12-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-12-14", "Last_Update_Posted(Estimated)" : 2018-11-09", "Last_Verified" : 2018-04" } }}

#Study Description Brief Summary The purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD\&HD in hypertensive patients in the routine clinical setting Detailed Description This is a special drug use surveillance on long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD combination tablets) to evaluate in hypertensive patients in the routine clinical setting. Because the drug contains a diuretic (hydrochlorothiazide) , it is necessary to assess the safety, especially on serum uric acid. (the planned sample size is 3000). The usual adult dosage is 1 tablet (4 mg/6.25 mg or 8 mg/6.25 mg as a candesartan cilexetil/hydrochlorothiazide) administered orally once daily. This drug should not be used as a first-line drug for hypertension treatment. #Intervention - DRUG : Candesartan cilexetil / hydrochlorothiazide - Candesartan cilexetil / hydrochlorothiazide combination tablets - Other Names : - ECARD® Combination Tablets LD&HD

#Eligibility Criteria: Inclusion Criteria: * Hypertensive patients Exclusion Criteria: (1) Patients with a history of hypersensitivity to ingredients of ECARD LD&HD combination tablets, thiazides, or their analogues (e.g. sulphonamide derivatives such as chlortalidone) (2) Patients with anuria or patients under hemodialysis (3) Patients with acute renal failure (4) Patients with noticeably decreased Na and K levels in body fluids (5) Pregnant women or women planning to become pregnant * Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT02016183

{ "NCT_ID" : "NCT03177772", "Brief_Title" : "Group Therapy For Dementia Caregivers At Risk For Complicated Grief", "Official_title" : "Group Therapy For Dementia Caregivers At Risk For Complicated Grief", "Conditions" : ["Grief"], "Interventions" : ["Behavioral: Pre-loss group therapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-03-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-05-28", "Study_Completion_Date(Actual)" : "2021-08-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-05-26", "First_Posted(Estimated)" : 2017-06-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-06-05", "Last_Update_Posted(Estimated)" : 2021-11-23", "Last_Verified" : 2021-11" } }}

#Study Description Brief Summary The investigators are adapting Complicated Grief Group Therapy (CGGT) for soon-to-be bereaved dementia caregivers at risk for complicated grief-Pre-Loss Group Therapy (PLGT) to facilitate healthy death preparedness and eventual bereavement. This will be the first known application of proven therapeutic strategies to address complicated grief applied to high-risk dementia caregivers prior to care recipient death to mitigate complicated grief. If proven to be effective in attenuating poor bereavement outcomes, PLGT could be translated into comprehensive caregiver support programs and delivered to active caregivers of living persons with dementia at risk for complicated grief through community-based caregiver support groups. Detailed Description In the investigators previous evaluation of Complicated Grief Group Therapy (CGGT) in bereaved dementia caregivers (2014-NIRG-305569), CGGT was administered to participants in a prospective, randomized-controlled trial. Participants in 5 treatment groups confirmed clinically significant reduction in complicated grief on the Inventory of Complicated Grief. In that study, intervention elements suitable for adaption in a preventative care approach were identified. The investigators are adapting these elements of CGGT for soon-to-be bereaved dementia caregivers at risk for complicated grief-Pre-Loss Group Therapy (PLGT) to facilitate healthy death preparedness and eventual bereavement. Specific Aims: 1) Assess preparedness for death and grief of bereaved and soon-to-be bereaved caregivers. 2) Adapt CGGT treatment elements into a manualized pre-loss preparedness group psychotherapy-(PLGT)-for dementia caregivers at risk for complicated grief. 3) Implement and evaluate three PLGT cohorts (NTotal = 40) in three long-term care facilities with family caregivers at-risk for complicated grief whose care recipient has a life expectancy of 6 months or less and resides in a long-term care facility. #Intervention - BEHAVIORAL : Pre-loss group therapy - The PLGT intervention will include CGGT treatment elements modified to address the pre-loss preparation of caregivers at risk for complicated grief, and will focus on the perceived relationship and attachment status between caregiver and care recipient, how memories of the life together, the illness and the death are interpreted, and strategies for preparing for life without the care recipient. These activities include elements of motivational interviewing, cognitive behavioral therapy and prolonged exposure therapy.

#Eligibility Criteria: Inclusion Criteria: * Study participants will be ADRD caregivers at risk for CG with a family member diagnosed with ADRD having a life expectancy of less than 6 months and residing in the facility. Caregivers with ADRD residents nearing death will be temporally closer to their grief/preparedness experience permitting 3 month post death follow-up within the study timeline. Eligibility (stage 1). Potential family caregiver participants will be identified by facility leadership (Medical Director, Social Worker and Director of Nursing) by these inclusion criteria: 1. resident ADRD diagnosis, 2. life expectancy, 'Would you be surprised if this resident died in the next 6 months?' and 3. caregiver proximity to facility permitting participation. Potential participants will receive an invitation phone call from the ResearchAssistant (RA). Eligibility (stage 2). Interested individuals will be invited to a pre-screening interview with the RA in person at the facility. Those who meet the final inclusion criteria, 4. minimum score of 4 on p-BGQ, and 5. positive scores on 4 of 9 risk factors will qualify Exclusion Criteria: * Active suicidality (likely hospitalization) will exclude interested individuals from participating Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03177772

{ "NCT_ID" : "NCT05895266", "Brief_Title" : "A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers", "Official_title" : "A Phase 1 Open-Label Drug-Drug Interaction Study Between ABBV-903 and Midazolam", "Conditions" : ["Healthy Volunteer"], "Interventions" : ["Drug: Midazolam", "Drug: ABBV-903"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SEQUENTIAL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2023-06-23", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-11-02", "Study_Completion_Date(Actual)" : "2023-11-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-05-31", "First_Posted(Estimated)" : 2023-06-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-05-31", "Last_Update_Posted(Estimated)" : 2023-11-09", "Last_Verified" : 2023-11" } }}

#Study Description Brief Summary The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants. #Intervention - DRUG : ABBV-903 - Oral Tablet - DRUG : Midazolam - Oral Liquid

#Eligibility Criteria: Inclusion Criteria: * BMI is >= 18.0 to <= 32 kg/m2 after rounding to the tenth. * Negative test result for SARS-CoV-2 infection upon initial confinement * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG. Exclusion Criteria: * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT05895266

{ "NCT_ID" : "NCT03627247", "Brief_Title" : "Impact of Stress Management on Cortisol Patterns in Low-Income Pregnant Women", "Official_title" : "Impact of a Cognitive Behavioral Stress Management Intervention on Cortisol Regulation During Pregnancy", "Conditions" : ["Pregnancy Related", "Stress, Physiological"], "Interventions" : ["Behavioral: Cognitive Behavioral Stress Management"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-12-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-08-30", "Study_Completion_Date(Actual)" : "2014-08-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-07-27", "First_Posted(Estimated)" : 2018-08-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-08-10", "Last_Update_Posted(Estimated)" : 2018-08-13", "Last_Verified" : 2018-08" } }}

#Study Description Brief Summary PROJECT NARRATIVE: As demonstrated by a growing number of studies, experiencing high levels of stress during pregnancy, including elevated levels of the stress hormone cortisol, can lead to significant long-term health problems for mothers and their infants. The objective of the proposed research is to test whether an innovative stress management intervention, offered during pregnancy, is effective in reducing stress and cortisol levels among low-income pregnant women. The results of the proposed work have substantial public health implications in helping to prevent the onset of stress-related health complications among mothers and their infants. Detailed Description PROJECT SUMMARY: As demonstrated by a growing number of studies, stress experienced during pregnancy can lead to significant long-term health problems for mothers and their infants. One biological mechanism that has been identified in heightening a woman's risk for developing stress-related health complications during pregnancy and the postpartum period is the stress hormone cortisol. However, the best methods for regulating cortisol, in order to optimize maternal and infant health outcomes, have received little attention. The objective of the proposed research is to conduct a two-arm, pilot randomized controlled study to test the efficacy of a prenatal cognitive behavioral stress management (CBSM) intervention in regulating cortisol and stress levels among low-income pregnant women. A total of 100 women will be randomized to either a group-based, 8-week prenatal CBSM arm (i.e., cognitive coping and relaxation skills training) or a standard-of-care comparison arm (i.e., usual pre- and postnatal care) to examine whether women receiving the CBSM intervention will have significantly lower cortisol output and stress levels, relative to women randomized to the standard-of-care comparison arm. This study will also examine whether these decreases in cortisol and stress levels are mediated through behavior change processes (e.g., increased self-efficacy and use of cognitive coping and relaxation skills). This hypothesis has been formulated on the basis of preliminary data collected by the principal investigator and study collaborators. Through formative research, this pilot work will develop and empirically test a prenatal CBSM stress management intervention among low-income pregnant women for use in local prenatal centers. The results of the proposed work have substantial public health implications and are expected to advance the investigator's understanding of how pregnant women effectively use these cognitive coping and relaxation skills to adopt healthy behaviors and produce change that can positively impact their health, as well as that of their infant. Further, the proposed research will yield a CBSM intervention that can be readily delivered in community settings, is scalable, and is relatively low cost. Finally, these results will help identify those subgroups of pregnant women that may do particularly well (or poorly) with these innovative approaches to stress management. This has important implications for the tailoring of CBSM programs to individual needs and preferences. #Intervention - BEHAVIORAL : Cognitive Behavioral Stress Management - Interactive activities (e.g., role-playing, use of physical props to introduce concepts related to coping and stress) were designed for each class to optimize participant engagement and understanding of the course material while tailoring class content to the stressors commonly reported by participants. Each week, participants were given coping and relaxation skills to practice at home (e.g., cognitive reappraisal, diaphragmatic breathing) and were asked to record their experiences on an activity log that was collected and discussed in class the following week. Course content was taught from a detailed training manual (Urizar \& Kofman, 2012).

#Eligibility Criteria: Inclusion Criteria: * 18 years or older * less than 17 weeks pregnant * fluent in either Spanish or English Exclusion Criteria: * Major medical problems (e.g., gestational diabetes, major depression) * Taking medications that may interfere with cortisol levels (e.g., asthma inhaler, antidepressants). Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT03627247

{ "NCT_ID" : "NCT03088358", "Brief_Title" : "Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement", "Official_title" : "A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement", "Conditions" : ["Total Knee Replacement"], "Interventions" : ["Drug: TeaRx", "Drug: Enoxaparin"], "Location_Countries" : ["Russian Federation"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-09", "Study_Completion_Date(Actual)" : "2015-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-02-26", "First_Posted(Estimated)" : 2017-03-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-03-18", "Last_Update_Posted(Estimated)" : 2017-03-23", "Last_Verified" : 2017-03" } }}

#Study Description Brief Summary To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group: * Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality * Incidence of DVT (total, proximal, distal) * Incidence of nonfatal PE * Incidence of symptomatic VTE (DVT, PE) * VTE caused mortality * Non-VTE caused mortality * Incidence of all hemorrhagic complications * Incidence of major and clinically relevant non-major bleeding * Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results #Intervention - DRUG : TeaRx - Other Names : - TeaRxaban - DRUG : Enoxaparin - Other Names : - Clexane ®

#Eligibility Criteria: Inclusion Criteria: * Male or female, age >= 18 years; * Planned total knee replacement surgery; * Signed informed consent form; * Willing to comply with the protocol; * Willing to use adequate contraception during the trial. Exclusion Criteria: * Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing * History of venous thrombosis of any location or PE * History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis * History of evident coagulopathy or in a relative * Congenital thrombophilia * Bleeding within 6 months of screening; increased risk of bleeding * BMI less than 18,5 or more than 40 kg/m2 * Systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg registered twice within 15 <= age <= 30 minutes * Hb <= 10.5 g/dL in female or <= 11.5 g/dL in male * Platelets < 100 000/mm3 * Clinical significant abnormalities of APTT and/or INR * GFR < 30 ml/min/1.73 m2 * ALT or AST >= 2 x ULN or total bilirubin >=1,5 x ULN Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03088358

{ "NCT_ID" : "NCT03036683", "Brief_Title" : "Transcranial Direct Current Stimulation in Offenders", "Official_title" : "The Effect of Transcranial Direct Current Stimulation on Risk-taking and Aggression in Offenders", "Conditions" : ["Aggression", "Risk-Taking", "Antisocial Behavior"], "Interventions" : ["Device: Transcranial direct current stimulation", "Device: Sham transcranial direct current stimulation"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-02-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-06-01", "Study_Completion_Date(Actual)" : "2022-06-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-01-26", "First_Posted(Estimated)" : 2017-01-30" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-01-26", "Last_Update_Posted(Estimated)" : 2022-10-18", "Last_Verified" : 2022-10" } }}

#Study Description Brief Summary This study investigates the effect of upregulating prefrontal cortex activity on risk-taking, and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized controlled trial, using a within-subject crossover design, each participant will undergo anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex and sham stimulation. After each stimulation session, neural activity and behavioral responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect of tDCS on violent offenders will also be assessed in comparison to age and gender-matched healthy controls. #Intervention - DEVICE : Transcranial direct current stimulation - Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany). - DEVICE : Sham transcranial direct current stimulation - The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.

#Eligibility Criteria: Inclusion Criteria: * Between 18 and 50 years * Able to understand the nature of the study and give informed consent * Individuals in the violent offender group must have a record of repeated violent criminal offending (at least 2 felonies). * Individuals in the violent offender group must have been convicted solely due to crimes involving violence motivated by impulsive aggression. Exclusion Criteria: * Presence of any contraindications for functional magnetic resonance imaging (fMRI) * History of significant medical illness * History of any neurological condition * Diagnosis of schizophrenia * History of epilepsy * Head injury * Mental retardation Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT03036683

{ "NCT_ID" : "NCT03669887", "Brief_Title" : "Lifestyle Modification to Improve Diet in Women With GDM", "Official_title" : "A Randomized Clinical Trial Using a Postnatal Lifestyle Modification Program to Improve Diet, Adiposity and Metabolic Outcome in Mothers With Gestational Diabetes and Their Offspring", "Conditions" : ["Gestational Diabetes", "Diabetes", "Childhood Obesity", "Diabetes Mellitus"], "Interventions" : ["Behavioral: Lifestyle Modification Program"], "Location_Countries" : ["Hong Kong"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-09-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-30", "Study_Completion_Date(Actual)" : "2020-12-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-09-12", "First_Posted(Estimated)" : 2018-09-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-09-12", "Last_Update_Posted(Estimated)" : 2022-03-15", "Last_Verified" : 2022-02" } }}

#Study Description Brief Summary The study aims to adapt a lifestyle modification program to engage GDM women early in the postnatal period to evaluate its effectiveness in reducing adiposity and metabolic parameters in the mother. Women will be randomized to receive a structured intervention or standard care. Detailed Description A complex intervention based on a proven lifestyle modification program (LMP) will be delivered to participants randomized to the intervention arm, starting in the early postnatal period. The intervention will consist of individualized face-to-face counseling on diet and weight management, meeting with exercise instructor, followed by telephone contact. Control will receive standard postnatal education materials and usual care provided by government health service. #Intervention - BEHAVIORAL : Lifestyle Modification Program - The intervention will consist of 5 individual face-to-face sessions at 2-weekly intervals with a dietitian with experience in lifestyle modification program, followed by monthly phone contact and smartphone text messages. All study participants in the intervention arm will also be arranged to meet with an exercise instructor at least once during the LMP on the same day as one of the dietitian appointment. Ongoing support from the exercise instructor will also be available by phone calls or emails.

#Eligibility Criteria: Inclusion Criteria: * Women who developed gestational diabetes in their most recent pregnancy * GDM is diagnosed according to the WHO 2013 criteria of FBG >= 5.1mmol/l, or 1 hour glucose >=10.0mmol/l, or 2 hour glucose >= 8.5mmol/l during 75g OGTT performed at 24 <= age <= 28 weeks of pregnancy * Singleton pregnancy * Reside normally in Hong Kong * Able to communicate in Chinese * Willing to give consent and follow study procedures Exclusion Criteria: * Subjects with pre-existing diabetes (T1D or T2D) * Subjects with life-threatening conditions including malignancy that is not in remission * Subjects with known psychiatric conditions including depression * Substance abuse or use of illicit substances * Subjects with significant renal impairment (eGFR<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy) * Subjects on chronic corticosteroids treatment * Subjects with known myocardial infarction within the preceding 3 months * Major physical disability * Participation in other intervention trials * Surgical or medical interventions to treat obesity * Pregnancy at any point during the intervention period Sex : FEMALE Ages : - Minimum Age : 20 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT03669887

{ "NCT_ID" : "NCT03919422", "Brief_Title" : "Paravertebral Block for Proximal Humeral Fracture Surgery", "Official_title" : "Effectiveness of Additional Thoracic Paravertebral Block in Improving Anesthetic Effects of Regional Anesthesia for Proximal Humeral Fracture Surgery in Elderly Patients: Study Protocol for a Randomized Controlled Trial", "Conditions" : ["Proximal Humeral Fracture"], "Interventions" : ["Procedure: T2 paravertebral block", "Procedure: interscalene brachial plexus block and superficial cervical plexus block"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-05-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-08-25", "Study_Completion_Date(Actual)" : "2020-08-26}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-04-14", "First_Submitted_that_Met_QC_Criteria" : 2021-01-02", "First_Posted(Estimated)" : 2019-04-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-04-16", "Last_Update_Posted(Estimated)" : 2021-01-05", "Last_Verified" : 2021-01" } }}

#Study Description Brief Summary This study evaluates the effects of T2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. The brachial plexus and cervical plexus block(IC block) will be performed in half of participants, while the T2 paravertebral block combined with IC block will be performed in the other half. #Intervention - PROCEDURE : T2 paravertebral block - Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin). - Other Names : - T2 PVB(paravertebral blockade ) - PROCEDURE : interscalene brachial plexus block and superficial cervical plexus block - An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus. - Other Names : - IC block

#Eligibility Criteria: Inclusion Criteria: * Participant age>= 65 years * Body mass index (BMI) < 30kg/m2 * American Society of Anesthesiologists (ASA) classification I-II * Anterior operative incision approach Exclusion Criteria: * Request for general anesthesia * Nerve block is unable to be performed due to various reasons * Coagulation dysfunction or anticoagulation therapy * History of upper limb nerve injury or phrenic nerve injury * Multiple trauma * Uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.) * Uncontrolled hypertension (systolic pressure over 180mmHg or diastolic pressure over 110mmHg) * Uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.) * Stroke or cognitive dysfunction (unable to communicate or cooperate) * Hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil) Sex : ALL Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: No

NCT03919422

{ "NCT_ID" : "NCT03217097", "Brief_Title" : "MGMT-NET: O6-methylguanine-DNA Methyltransferase (MGMT) Status in Neuroendocrine Tumors: Predictive Factor of Response to Alkylating Agents", "Official_title" : "MGMT-NET: O6-methylguanine-DNA Methyltransferase (MGMT) Status in Neuroendocrine Tumors: Predictive Factor of Response to Alkylating Agents", "Conditions" : ["Neuroendocrine Tumors"], "Interventions" : ["Drug: Alkylating-based chemotherapy", "Drug: Oxaliplatin-based chemotherapy"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-10-16", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-31", "Study_Completion_Date(Actual)" : "2022-04-25}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-07-12", "First_Posted(Estimated)" : 2017-07-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-07-12", "Last_Update_Posted(Estimated)" : 2022-11-04", "Last_Verified" : 2022-11" } }}

#Study Description Brief Summary Neuroendocrine tumors (NET) are rare but their incidence is growing. Alkylating agents (ALKY) are one of the main systemic treatments used, at least for advanced duodeno-pancreatic NETs, with a response rate of 30 to 40% and a median progression-free survival of 4 to 18 months. Chemotherapy is one of the few therapeutic weapons, along with everolimus, somatostatin analogs, and metabolic radiotherapy, for lung NETs, called typical and atypical carcinoids, even if the level of proof of efficacy for these treatments is lower than for duodeno-pancreatic NETs. Considering the available retrospective data, O6-Methylguanine-DNA methyltransferase (MGMT) appears to be a predictive factor of the response to ALKY. Oxaliplatin (OX) has demonstrated an interesting activity, with response rates between 17% and 30%. In a first retrospective study we showed that Gemox is effective in NET, and more recently that its activity is similar to that of ALKYs, but without being influenced by the MGMT status. Prospective studies are needed but our data suggests that ALKY should be offered first to patients with methylated MGMT tumors while Oxaliplatin-based chemotherapy should be offered first to patients with unmethylated MGMT tumors. In this project, we wish to evaluate the contribution of the MGMT methylation, evaluated in the tumor, in predicting the Objective Response (OR) in patients treated with ALKY and to evaluate a treatment with alkylating agents versus Oxaliplatin in patients with a duodeno-pancreatic or lung or unknown primitive NET. #Intervention - DRUG : Oxaliplatin-based chemotherapy - The 'oxaliplatin-based' group will receive gemox (gemcitabine-oxaliplatin, 1x/2 week); alternatively folfox (5 fluorouracil-leucovorin-oxaliplatin, 1x/2 week) or capox (capecitabine-oxaliplatin, 1x/3 week). - DRUG : Alkylating-based chemotherapy - The 'alkylating-based' group will receive CapTem regimen (capecitabine and temozolomide, /4 week), alternatively LV5FU2 (folinic acid-5 fluorouracil)-dacarbazine (1x/2 week) or LV5FU2 (folinic acid-5-fluorouracil)-streptozotocine (1x/2 week).

#Eligibility Criteria: Inclusion Criteria: * Age greater than or equal to 18 years; * Patient presenting well-differentiated advanced grade 1 <= age <= 3 (locally/metastatic) duodeno-pancreatic or thoracic (lung or thymus) or unknown primitive NETs, not curable with surgery. * Patients must have measurable disease using the RECIST v1.1 criteria; * Indication for cytotoxic systemic chemotherapy validated by the dedicated Multidisciplinary Tumor Board; * MRI or TAP CT scan with contrast agents within 4 weeks +/- 1 week before beginning of treatment; * Tumor tissue available (fresh frozen or paraffin-embedded) in order to search for the methyl guanine methyltransferase (MGMT) status; * Patients with childbearing potential should use effective contraception during the study and the following 6 months; * Covered by a Healthcare System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research; * Subject able to understand and willing to sign a written informed consent document; * Signed written informed consent obtained prior to any study-specific screening procedures. Previous treatments such as surgery, radiofrequency ablation, transarterial liver embolization, somatostatin analogs, interferon, everolimus or other targeted therapy, peptide receptor radionuclide treatment (PRRT) and chemotherapy (platin-etoposide, folfiri, paclitaxel or docetaxel) are allowed. Exclusion Criteria: * Previous chemotherapy using Oxaliplatin or ALKY (streptozotocin, dacarbazin or temozolomide). Other chemotherapy (platin-etoposide, folfiri, paclitaxel or docetaxel) are allowed; * Pregnant or breastfeeding; * Men and women of childbearing age potential not using medically accepted contraceptive measures, as judged by the investigator; * Contraindication to any drug contained in the chemotherapy regimen; * Any significant disease which, in the investigator's opinion, excludes the patient from the study; * Under any administrative or legal supervision. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03217097

{ "NCT_ID" : "NCT02060058", "Brief_Title" : "Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy", "Official_title" : "Boceprevir-based Triple Therapy to Rescue HCV Genotype 1/HBV Dually Infected Patients Refractory to Peginterferon Plus Ribavirin Combination Therapy", "Conditions" : ["Hepatitis C, Chronic"], "Interventions" : ["Drug: Stop trial intervention for boceprevir, PEG-IFN and RBV"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09", "Study_Completion_Date(Actual)" : "2016-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-01-27", "First_Submitted_that_Met_QC_Criteria" : 2018-03-12", "First_Posted(Estimated)" : 2014-02-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-02-09", "Last_Update_Posted(Estimated)" : 2018-03-13", "Last_Verified" : 2016-05" } }}

#Study Description Brief Summary The aim of this study is to explore the efficacy and safety of boceprevir -based triple therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy. Detailed Description Liver disease, especially viral hepatitis, is an important public health issue, which frequent leads to liver cirrhosis, hepatocellular carcinoma (HCC) and liver-related death. Around 340 to 400 million persons are infected with hepatitis B virus (HBV) and 130 to 210 million persons are infected with hepatitis C virus (HCV) worldwide, In Taiwan, the prevalence of HBV infection is 15-20%, and the prevalence of HCV infection is 2-5% in general population. Moreover, there are some HCV-hyperendemic areas in southern Taiwan with anti-HCV prevalence rate of as high as 30-40%. HBV/HCV dual infections is not uncommon in HBV epidemic areas, such as Southeastern Asia, with a prevalence rate of 1.1% in southern Taiwan. Recent study showed that the risk of HCC incidence is even higher among HBV/HCV co-infected persons than those with HBV or HCV mono-infection, indicating the importance of disease control in this clinical setting. The PEG-IFN/RBV has been effective in the treatment of HCV-dominant, treatment-naïve patients with HCV/HBV dual infections. For treatment-naive HCV genotype 1 (HCV GT1)/HBV co-infected patients, 48 weeks of peginterferon (PEG-IFN) plus ribavirin (RBV) could achieve an HCV sustained virological response (SVR) rate of 72%, which was comparable to 77% for patients with HCV GT1 monoinfection. For treatment-naive HCV GT2 or GT3 /HBV co-infected patients, 24 weeks of PEG-IFN plus RBV could achieve an HCV SVR rate of 83%, which was comparable to 84% for patients with HCV GT2/3 monoinfection . Furthermore, PEG-IFN plus RBV combination therapy could enhance seroclearance of hepatitis B surface antigen (HBsAg) with an HBsAg loss rate of upto 11%. Nevertheless, there is about 30% of HCV GT1/HBV and 20% of HCV GT2 or 3/HBV co-infected patients refractory to current PEG-IFN/RBV combination therapy, which remains at high risk of HCC and liver-related death. Boceprevir is an oral antiviral drug, which is NS3/4A protease inhibitor. Boceprevir has been approved for treating HCV GT1 infection by Food and Drug Administration (FDA) on 11 May 2011. For HCV GT1 mono-infected patients who refractory to previous PEG-IFN plus RBV combination therapy, becoprevir combined with PEG-IFN/RBV triple therapy can improve the treatment efficacy. The SVR rate of becoprevir-based triple therapy is about 3 times when compared to patients who received PEG-IFN with RBV dual therapy \[14\].The investigators , therefore, hypothesize that boceprevir plus PEG-IFN/RBV is effective in treating HCV GT1/HBV dually infected patients who are refractory to previous PEG-IFN/RBV combination therapy. #Intervention - DRUG : Stop trial intervention for boceprevir, PEG-IFN and RBV - Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. - Other Names : - Stop trial intervention for arm A, Stop trial intervention for arm B, Stop trial intervention for arm C

#Eligibility Criteria: Inclusion Criteria: * 1. Patient must be >= 20 years * 2. Patient must have HCV GT1 infection combined with HBV infection. * 3. Patients must be serum HCV RNA detectable, anti-HCV positive, HBsAg positive and HBeAg negative. * 4. Patient has previously failed treatment with PEG-IFN-α 2a or 2b/RBV for minimum of 12 weeks of treatment. * 5. Patient must have compensated liver disease consistent with CHC and/or CHB, and no other etiology. Note: patients with cirrhosis should have a liver imaging study (e.g. ultrasound, CT scan or MRI) within the preceding 6 months showing no evidence of hepatocellular carcinoma. * 6. Patient meets all of the requirements and none of the contra-indications for treatment with PEG-IFN alpha-2b/RBV or boceprevir defined in the labels for the PEG-IFN/RBV to be used in combination with boceprevir. * 7. Patient is able and willing to provide signed informed consent (prepared by and administered by the physician) as required by local country requirements. Exclusion Criteria: * 1. Mixed genotypes including HCV genotype other than genotype 1. * 2. Patient has received boceprevir, narlaprevir, telaprevir, or any other HCV protease inhibitor treatment. * 3. Patient has evidence of decompensated liver disease including but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. * 4. Patient meets any of the following exclusionary hematologic and biochemical criteria (documentation required) Hemoglobin <12 gm/dL for females and <13 gm/dL for males Neutrophils <1500/mm3 Platelets <100,000/mm3 * 5. Patient has an organ transplant other than cornea or hair. * 6. Patient is co-infected with human immunodeficiency virus (HIV) * 7. Patient requires or is anticipated to require any of the following prohibited medications: midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives * 8. Patient with clinical diagnosis or evidence of substance abuse involving alcohol, intravenous drugs, inhalational psychotropics, narcotics, cocaine prescription or over-the-counter drugs. * 9. Patient previously demonstrated clinically significant hypersensitivity or other contraindication to any component of the boceprevir formulation. This drug contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. * 10. Serious illness, including malignancy, active coronary artery disease or cardiac dysfunction within 24 weeks prior to study entry, that in the opinion of the site investigator may preclude completion of the treatment regimen. * 11. Major hemoglobinopathy (e.g., thalassemia major), coagulopathy or any other cause of or tendency to hemolysis or bleeding Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02060058

{ "NCT_ID" : "NCT02417415", "Brief_Title" : "Local Heat Stress in Autonomic Failure Patients With Supine Hypertension", "Official_title" : "Local Heat Stress in Autonomic Failure Patients With Supine Hypertension", "Conditions" : ["Hypertension", "Pure Autonomic Failure", "Multiple System Atrophy", "Autonomic Failure"], "Interventions" : ["Other: Control (non-heating)", "Other: Passive heat stress"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-02", "Study_Completion_Date(Actual)" : "2021-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-04-10", "First_Submitted_that_Met_QC_Criteria" : 2021-12-25", "First_Posted(Estimated)" : 2015-04-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-04-14", "Last_Update_Posted(Estimated)" : 2022-03-10", "Last_Verified" : 2021-12" } }}

#Study Description Brief Summary Patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing), and at least half of them also have high blood pressure while lying down (supine hypertension). Exposure to heat, such as in hot environments, often worsens their orthostatic hypotension. The causes of this are not fully understood. The purpose of this study is to evaluate whether applying local heat over the abdomen of patients with autonomic failure and supine hypertension would decrease their high blood pressure while lying down. This will help us better understand the mechanisms underlying this phenomenon, and may be of use in the treatment of supine hypertension. Detailed Description Primary autonomic failure is a neurodegenerative condition characterized by severe impairment of the autonomic nervous system. The clinical hallmark of autonomic failure is disabling orthostatic hypotension, but at least half of patients are also hypertensive while lying down. This supine hypertension can be severe and associated with end-organ damage and worsening of orthostatic hypotension due to increased pressure natriuresis. It also complicates the management of these patients by limiting the use of daytime pressor agents for the treatment of orthostatic hypotension. It is well known that heat exposure (e.g. hot weather or a hot bath or shower) produces an acute and temporary worsening of orthostatic hypotension in autonomic failure patients. However, the mechanisms underlying this phenomenon are completely unexplored. Factors that may predispose autonomic failure patients to the acute lowering blood pressure effects of heat stress include 1) impaired heat dissipation due to inability to sweat, 2) preserved heat-mediated skin vasodilation, and 3) blunted sympathetic hemodynamic responses to maintain blood pressure. In this study, we test the hypothesis that moderate levels of local (abdominal) passive heat stress will lower blood pressure in autonomic failure patients with supine hypertension. To test this hypothesis, we propose this pilot study with the following specific aims: 1. To evaluate the acute blood pressure effects of local passive heat stress in autonomic failure patients with supine hypertension, we will compare changes in BP between controlled local heat stress (\~44ºC) using a commercial heating pad that covers the abdomen and part of the torso, and a control (non-heating) study day using the same heating pad but turned off. 2. To evaluate the mechanisms underlying BP changes during local heat stress, we will compare changes in hemodynamic parameters (cardiac output, stroke volume and peripheral vascular resistance), segmental fluid shifts (measured by segmental bioimpedance), skin blood flow and skin temperature between the heat and non-heating study days. #Intervention - OTHER : Passive heat stress - Passive heat stress will be applied with a commercial heating pad that covers all the abdomen and part of the torso to provide local heating at \~44ºC continuously for 2 hr. - Other Names : - Heating pad - OTHER : Control (non-heating) - Heating pad will be applied over the abdomen and part of the torso but it will be turned off. - Other Names : - sham

#Eligibility Criteria: Inclusion Criteria: * Male and female patients, between 18 <= age <= 80 yrs., with primary autonomic failure (Parkinson Disease, Multiple System Atrophy, and Pure Autonomic Failure) and supine hypertension. Supine hypertension will be defined as SBP>=150 mmHg. * Patients able and willing to provide informed consent. Exclusion Criteria: * Pregnancy * Significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or with other factors, which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02417415

{ "NCT_ID" : "NCT01681875", "Brief_Title" : "Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes", "Official_title" : "Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes", "Conditions" : ["Tobacco Dependence"], "Interventions" : ["Other: very low nicotine content cigarettes"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-07", "Study_Completion_Date(Actual)" : "2014-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-08-30", "First_Posted(Estimated)" : 2012-09-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-09-05", "Last_Update_Posted(Estimated)" : 2018-08-15", "Last_Verified" : 2018-08" } }}

#Study Description Brief Summary Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use. #Intervention - OTHER : very low nicotine content cigarettes

#Eligibility Criteria: Inclusion Criteria: * Age 18+ * Smoke an average of at least five cigarettes per day for at least 1 year * Breath CO levels > 8 ppm (if <= 8 ppm, then NicAlert Strip > 2) Exclusion Criteria: * Intention to quit smoking in the next 30 days * Currently seeking treatment for smoking cessation * Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable) * A quit attempt in the past 30 days resulting in greater than 3 days of abstinence * Using other tobacco products more than 9 days in the past 30 days * Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site) * Significant unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site) * Schizophrenia and schizoaffective disorder * Psychiatric medication changes in the past 3 months * Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP 1. Marijuana will be tested for but will not be an exclusionary criterion. 2. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. 3. Participants failing the toxicology screen will be allowed to re-screen once. * Blood alcohol level > 0.01 a. Participants failing the blood alcohol screen will be allowed to re-screen once. * Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 in a 2 hour period(female/male)) * Pregnant or breastfeeding * Smoking 'roll your own cigarettes' exclusively * Currently taking anticonvulsant medication * CO reading >80 ppm * Systolic BP greater than or equal to 160 a. Participants failing for blood pressure will be allowed to re-screen once. * Diastolic BP greater than or equal to 100 a. Participants failing for blood pressure will be allowed to re-screen once. * Systolic BP below 90 a. Participants failing for blood pressure will be allowed to re-screen once. * Diastolic BP below 50 a. Participants failing for blood pressure will be allowed to re-screen once. * Heart rate greater than or equal to 115bpm a. Participants failing for heart rate will be allowed to re-screen once. * Heart rate lower than 45bpm a. Participants failing for heart rate will be allowed to re-screen once. * Indicating any suicidal ideation in the past month or suicide attempts in the past 10 years * Inability to independently read and comprehend the consent form and other written study materials and measures * Having participated in a research study during the past three months in which the participant: 1. Smoked a cigarette that was not his/her usual brand cigarette for more than one day 2. Used any tobacco products beyond normal use for more than one day 3. Used any nicotine replacement products or smoking cessation medications for more than one day Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01681875

{ "NCT_ID" : "NCT02574130", "Brief_Title" : "Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria", "Official_title" : "Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria", "Conditions" : ["Pneumonia, Ventilator-Associated"], "Interventions" : ["Drug: Amikacin", "Drug: Placebo"], "Location_Countries" : ["Thailand"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-04", "Study_Completion_Date(Actual)" : "2018-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-10-09", "First_Posted(Estimated)" : 2015-10-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-10-09", "Last_Update_Posted(Estimated)" : 2018-04-26", "Last_Verified" : 2018-04" } }}

#Study Description Brief Summary The purpose of this study is to determine the cure rate from ventilator-associated pneumonia (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to intravenous antibiotics compared to intravenous antibiotics alone. Detailed Description After inclusion, the patients are randomized into two groups: nebulized amikacin plus intravenous antibiotic(s) or nebulized placebo plus intravenous antibiotic(s). The dose of nebulized amikacin is 400 mg every 12 hours for 10 days. The patients are followed up on day 3, 7, 10, and 28 for safety and efficacy. The estimate sample size is 84 subjects base on previous study of cure rate in VAP and the authors expected that nebulized amikacin can improve cure rate in VAP subjects for 30% when compared with intravenous antibiotic(s) alone with power of 80% at level of significance 0.05. #Intervention - DRUG : Amikacin - 400 mg, nebulizer, every 12 hours, 10 days - Other Names : - Amikin - DRUG : Placebo - placebo 4 ml, nebulizer, every 12 hours, 10 days

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * On mechanical ventilator more than 7 days * VAP diagnosis inclusion criteria: 1. new/progressive infiltration of chest radiography 2. 2/3 of the following: 1) fever 2) purulent sputum 3) Wbc > 12,000 cell/mm3 or < 4,000 cell/mm3 * Evidence of gram negative bacilli from sputum gram stain or previous sputum culture within 1 week Exclusion Criteria: * History of amikacin allergy * GFR < 30 mL/min except dialytic patients * Immunocompromised host: HIV CD4 < 200 cells/mm3, leukemia, lymphoma, received chemotherapy within 3 weeks, Absolute neutrophil count < 500/mm3 * Severe ARDS (P/F ratio < 100) * Endobronchial obstruction:endobronchial mass, endobronchial stenosis * Atelectasis * Severe bronchospasm * Lung abscess * Complicated parapneumonic effusion/ Empyema * Chest trauma * Uncontrolled extrapulmonary infection(s) * Received intravenous antibiotic(s) more than 48 hours * Pregnancy/ Lactation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02574130

{ "NCT_ID" : "NCT04932850", "Brief_Title" : "Study to Evaluate the Safety and Concentrations of Monoclonal Antibody Against Virus That Causes COVID-19 Disease.", "Official_title" : "COVID-19: A Phase I Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of Anti-SARS-CoV-2 Monoclonal Antibody MAD0004J08 in Healthy Adults.", "Conditions" : ["COVID-19 Virus Disease"], "Interventions" : ["Other: Placebo", "Biological: MAD0004J08"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-03-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-10-20", "Study_Completion_Date(Actual)" : "2021-10-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-06-15", "First_Posted(Estimated)" : 2021-06-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-06-17", "Last_Update_Posted(Estimated)" : 2022-04-27", "Last_Verified" : 2022-04" } }}

#Study Description Brief Summary A Phase I dose-escalation study to test a new monoclonal antibody (called MAD0004J08) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19 disease. The study aims to evaluate the safety and pharmacokinetics (distribution and elimination) of anti-SARSCoV-2 monoclonal antibody in healthy adults. The primary objective of the study is to evaluate the safety of anti-SARSCoV-2 monoclonal antibody (that is the appearance of adverse events), the pharmacokinetics (how MAD0004J08 is distributed and eliminated by human body), the generation of anti-drug antibodies (ADAs) (that is the possible production of antibodies against the drug, which could invalidate it efficacy) and finally the ability of MAD0004J08 to neutralize SARSCoV-2. Furthermore a blood sample would be used to evaluate a kit (DIESSE kit), developed by Toscana Life Sciences, able to detect the administered drug. This kit is not used to evaluate study paramethers. 30 subjects, that should respect the Inclusion/Exclusion criteria, will be enrolled. About 12 visits will be performed during the study, study duration will be about 6 months. Subjects will be distributed into 3 Cohorts, each of them divided into 2 groups that would receive MAD0004J08 (Dose 1 = 48 mg, Dose 2 = 100 mg or Dose 3 = 400 mg) or placebo. Administration occurs as intramuscular injection (single injection for Cohort 1 and Cohort 2 and, two injections for Cohort 3) . Detailed Description A Phase I dose-escalation study to evaluate the safety and pharmacokinetics of anti-SARSCoV- 2 monoclonal antibody MAD0004J08 in healthy adults. Two Italian clinical sites are involved in the study. It is a first-in-human, single-dose, dose-escalation, double-blind, placebo-controlled, randomised, safety and pharmacokinetics study. Three single ascending doses (48 mg, 100 mg and 400 mg) and placebo will be administered by intramuscular injection to three study cohorts (10 subjects/cohort) as single doses, in the morning of day 1. There are 5 sentinel subjects for each Cohort, they will be treated one at the time at 48 h distance (after evaluation of any possible treatment related adverse event). Active treatment and placebo will be assigned within each cohort and group according to the study randomisation list. Go/No-go decision on escalation from Cohort 1 to Cohort 2 and from Cohort 2 to Cohort 3 will be taken after evaluation of Cohort 1/Cohort 2 safety data up to 48 h post-dose by an independent Data Safety Monitoring Board. The primary objective of the study is to evaluate the safety of three single dose levels of MAD0004J08 in healthy subjects. Secondary objectives are to evaluate the pharmacokinetics of MAD0004J08, potency in terms of serum neutralisation power and immunogenicity in terms of generation of anti-drug antibodies (ADAs) after single dose of 48 mg, 100 mg and 400 mg. The following procedures will be performed: Visit 1 - Screening Day -21 / Day -2 * Explanation to the subject of study aims, procedures and possible risks * Informed consent signature * Screening number assignment (as S001, S002, etc.) * Demographic data and life style recording * Medical history * Previous/concomitant medications * Physical examination (including body weight, height) * Vital signs (blood pressure, heart rate, body temperature) * 12-lead Electrocardiogram (ECG) * SARS-CoV-2 serology test * Laboratory analyses: haematology, blood chemistry, urinalysis, serum virology, coagulation, ferritin * Drug of abuse test * Urinary pregnancy test (women) * SARS-CoV-2 Real-Time Quantitative Reverse Transcription PCR (qRT-PCR) in the 72 h before day 1 (could be performed on day -3 or day-2 or day -1) * Adverse event monitoring * Inclusion/exclusion criteria evaluation * Eligibility evaluation Visit 2 - Day -1 * SARS-CoV-2 qRT-PCR in the 72 h before treatment. On day -1 either test performance, or result check if already performed on day -3 or day -2 * Drug of abuse test * Inclusion/exclusion criteria evaluation * Check of AEs and concomitant medications * Vital signs (blood pressure, heart rate, body temperature) * Physical examination * Eligibility evaluation Visit 3 - Day 1 * Urine pregnancy test (women) * Inclusion/exclusion criteria evaluation, eligibility evaluation, and randomisation * 12-lead ECG * Dispensation of 2 diaries to the subject (diary 1 to report solicited adverse events from day 1 to day 8, diary 2 to report all unsolicited adverse events and concomitant medication from day 1 to month 1) * Laboratory analyses: haematology, coagulation, blood chemistry, urinalysis, SARS-CoV-2 serology test - baseline * Blood sample collection for pharmacokinetic analysis at predose (0) and 1h, 2h, 3h, 4h, 6h, 8h, 12h post-dose * Blood sample collection for ADA analysis at pre-dose (0) * Blood sample collection for serum neutralising power test at pre-dose (0) * Blood sample collection for DIESSE Elisa kit characterisation at pre-dose (0) * Vital signs (blood pressure, heart rate, body temperature) measurement at pre-dose (0), 2h post-dose and 12 h post-dose * Investigational product administration (active or placebo according to study Cohort, Group and randomisation) * Adverse events monitoring * Injection site reactions check * Concomitant medications check Visit 4 - Day 2 * Physical examination * Vital signs (blood pressure, heart rate, body temperature) measurement at 24 h post-dose * Blood sample collection for pharmacokinetic analysis at 24h post-dose * Adverse events monitoring * Injection site reactions check * Diary 1 and diary 2 check * Concomitant medications check * Laboratory analyses: haematology, blood chemistry, coagulation, urinalysis, SARS-CoV-2 serology test at 24 h post-dose * 12-lead ECG at 24 h post-dose Visit 5 - Day 3 * Vital signs (blood pressure, heart rate, body temperature) measurement at 48 h post-dose * Blood sample collection for pharmacokinetic analysis at 48h post-dose * Blood sample collection for serum neutralising power test at 48h post-dose * Blood sample collection for DIESSE Elisa kit characterisation at 48 h post-dose * Adverse events monitoring * Injection site reactions check * Diary 1 and diary 2 check * Concomitant medications check * Laboratory analyses: haematology, blood chemistry, coagulation, urinalysis, SARS-CoV-2 serology test - at 48 h post-dose * Physical examination Visits 6 / Week 1 / Day 8 and Visit 7 / Week 2 / Day 15±2 * Physical examination * Vital signs (blood pressure, heart rate, body temperature) measurement * Blood sample collection for pharmacokinetic analysis * Blood sample collection for ADA analysis * Blood sample collection for serum neutralising power test on day 8 only * Blood sample collection for DIESSE Elisa kit characterisation on day 8 only * Adverse events monitoring * Concomitant medications check * Laboratory analyses: haematology, blood chemistry, coagulation, urinalysis, SARS-CoV-2 serology test * Diary 1 check - day 8 only * Diary 2 check - day 8 and day 15 * Subjects' diary 1 return - day 8 only Visit 8 Week 3 Day 22±2 * Physical examination * Vital signs (blood pressure, heart rate, body temperature) * Blood sample collection for pharmacokinetic analysis * Adverse events monitoring * Diary 2 check * Concomitant medications check * Laboratory analyses: haematology, blood chemistry, coagulation, urinalysis, SARS-CoV-2 serology test Visit 9 - 1 month Day 30±3 * Physical examination * Vital signs (blood pressure, heart rate, body temperature) measurement * Blood sample collection for pharmacokinetic analysis * Blood sample collection for ADA analysis * Blood sample collection for serum neutralising power test * Blood sample collection for DIESSE Elisa kit characterisation * Adverse events monitoring * Diary 2 check * Concomitant medications check * Laboratory analyses: haematology, blood chemistry, coagulation, urinalysis, SARS-CoV-2 serology test * Urine pregnancy test (women) * Subjects' diary 2 return Visit 10 - 2 months Day 60±4 * Physical examination * Vital signs (blood pressure, heart rate, body temperature) measurement * Blood sample collection for pharmacokinetic analysis * Adverse events monitoring * Concomitant medications check * Laboratory analyses: haematology, blood chemistry, coagulation, urinalysis, SARS-CoV-2 serology test * Urine pregnancy test (women) Visit 11 - 4 months Day 120±4 days * Physical examination * Vital signs (blood pressure, heart rate, body temperature) measurement * Blood sample collection for pharmacokinetic analysis * Blood sample collection for ADA * Blood sample collection for serum neutralising power test * Blood sample collection for DIESSE Elisa kit characterisation * Adverse events monitoring * Concomitant medications check * Laboratory analyses: haematology, blood chemistry, coagulation, urinalysis, SARS-CoV-2 serology test * Urine pregnancy test (women) Visit 12 - 6 months Final visit Day 180±7 days * Physical examination (including body weight) * Vital signs (blood pressure, heart rate, body temperature) measurement * Blood sample collection for pharmacokinetic analysis * Blood sample collection for ADA * Blood sample collection for serum neutralising power test * Blood sample collection for DIESSE Elisa kit characterisation * Adverse events monitoring * Concomitant medications check * Laboratory analyses: haematology, blood chemistry, urinalysis, coagulation, SARS-CoV-2 serology test * 12-lead ECG The data documented in this trial and the measured clinical parameters will be presented using classic descriptive statistics for quantitative variables and frequencies for qualitative variables. A Statistical Analysis Plan will be prepared by CROSS Research S.A. Biometry Unit, approved by the Sponsor and finalised before database lock. Safety, serum neutralising power, immunogenicity and demography data will be analysed by CROSS Research Biometry Unit using SAS® version 9.3 (TS1M1) or higher (the actual version will be stated in the final report). Adverse events and serious adverse events (including clinically significant laboratory parameters, vital signs, ECG results and adverse reactions at the injection sites) will be listed by treatment. Number and percentage of subjects with adverse events and serious adverse events will be summarised. Serum MAD0004J08 concentrations and pharmacokinetic parameters will be analysed using Phoenix WinNonlin® validated version 6.3 or higher (Pharsight Corporation) and SAS® version 9.3 for Windows® or higher. Pharmacokinetics data will be listed and summarised by descriptive statistics. Individual and mean concentration curves will also be generated. ADA concentrations will be summarised by descriptive statistics. Number and percentage of ADA-positive subjects will be listed and summarised by assessment time and overall. Serum neutralising power results will be listed by subject and assessment time-point and summarised by descriptive statistics. #Intervention - BIOLOGICAL : MAD0004J08 - Human mAb 100 mg / 2.5 mL solution for injection - OTHER : Placebo - Placebo matching to MAD0004J08 2.5 mL solution for injection

#Eligibility Criteria: Inclusion Criteria: * Informed consent: Signed written informed consent before inclusion in the study * Full comprehension: Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study * Sex and age: Healthy men and women, 18 - 55 years, inclusive * Negative SARS-CoV-2 serology test at screening (negative anti-S and anti-N) * Negative SARS-CoV-2 qRT-PCR in the 72 h before treatment (test on day -3 or -2 or -1 with result before treatment) * Body Mass Index: 18.5 <= age <= 30 kg/m2, inclusive, at screening * Vital signs: Systolic blood pressure 90 <= age <= 139 mmHg, diastolic blood pressure 60 <= age <= 90 mmHg, heart rate 50 <= age <= 100 bpm, measured after 5 min at rest in the supine position * ECG: Electrocardiogram without clinically significant abnormalities at screening * Contraception and fertility: Women of child-bearing potential must be using at least one of the following reliable methods of contraception and confirm to use adequate contraception during the study: 1. Hormonal oral or implantable or transdermal, or injectable contraceptives for at least 2 months before the screening visit; 2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit 3. A male sexual partner who agrees to use a male condom with spermicide 4. A sterile sexual partner 5. A same sex partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women, urine pregnancy test result must be negative at screening and day 1 Exclusion Criteria: * Physical findings: Clinically significant abnormal physical findings which could interfere with the objectives of the study * Allergy: Ascertained or presumptive hypersensitivity to the active principle and/or ingredients of the investigational products; history of anaphylaxis to drugs or allergic reactions likely to be exacerbated by any component of the investigational products in the Investigator's opinion * Concomitant medications: Medications, including over the counter (OTC) medications and herbal remedies, for 2 weeks before screening and immunoglobulin or blood products for 6 months before screening (except contraceptives or a single use of paracetamol, aspirin, or combination OTC products containing paracetamol with an antihistamine, or OTC non-steroidal anti-inflammatory drugs (NSAIDs) at a dose equal or lower than that recommended on the package; vitamins and nutritional supplements, if regularly taken before the study, are also allowed) * Monoclonal Antibodies (mAb): Previous intake of a mAb within 6 months, or 5 antibody half-life, whichever is longer, before study start * Transient acute illness: Acute (time-limited) illness, including fever above 37.5°C on the day before or on the day of the planned treatment; subjects excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once * Diseases: Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, psychiatric or neurological diseases that may interfere with the aim of the study or increase subjects risks; history of malignancy in the last 5 years * SARS CoV-2 or COVID-19: 1. Participants with any confirmed current or previous COVID-19 infection at screening, or at day -1 or day 1 2. Participant with clinical signs or symptoms consistent with COVID-19, e.g. fever, dry cough, dyspnoea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks before/at screening or at day -1 or day 1 3. Any prior intake of investigational or licenced vaccine indicated for the prevention of SARS CoV-2 or COVID-19 or expected intake during follow-up period 4. Has been reported as a case (confirmed or probable) of COVID-19 from the regional health system * Immunodeficiency due to illness, including HIV infection (positivity to anti-HIV-Ab), or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent within 6 months before screening. * Infections: History of active infection with hepatitis B or C or positive test result for anti-HCV-Ab or HBsAg or anti-HBc-Ab at screening; history of infection with SARS or MERS * Laboratory analyses: Abnormal laboratory values that in the opinion of the Investigator are clinically significant * Investigative drug studies: Participation in the evaluation of any investigational product for 6 months before this study * Blood donation: blood donations for 3 months before the study, during the study and in the 3 months after the end of the study * Drug test: positive drug test at screening or day -1 * Drug, alcohol: history of drug or alcohol abuse within 6 months before screening * Pregnancy (women only): positive or missing pregnancy test at screening or day 1; pregnant or lactating women * Other: Any condition that might compromise study subject's safety or interfere with the study evaluations or interpretation of subject's safety or study results Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT04932850

{ "NCT_ID" : "NCT01886924", "Brief_Title" : "Computer MI for Tobacco Quitline Engagement in Smokers Living With HIV", "Official_title" : "Computer-based MI to Engage Smokers Living With HIV in Tobacco Quitline Treatment", "Conditions" : ["Smoking Cessation"], "Interventions" : ["Behavioral: Brief Computer MI for Smoking Cessation", "Behavioral: Nutrition Control"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-05", "Study_Completion_Date(Actual)" : "2015-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-06-24", "First_Posted(Estimated)" : 2013-06-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-06-24", "Last_Update_Posted(Estimated)" : 2016-07-20", "Last_Verified" : 2016-07" } }}

#Study Description Brief Summary The long-term goal of this program of research is to disseminate an effective, brief computer-based intervention that can be readily integrated into HIV treatment settings to motivate tobacco quitline use among smokers living with HIV. The overall objective of this application is to develop this computer intervention, modify it based on initial piloting and feedback, and obtain preliminary data supporting the efficacy of the intervention. This will be accomplished by pursuing three specific aims: 1) to develop and conduct preliminary pilot testing (n=16) of a brief, computer-based intervention intended to motivate tobacco quitline use among cigarette smokers living with HIV (Computer Intervention to Motivate Engagement in Tobacco Quitline treatment; CI-METQ) and to develop and pilot (n=4) a computer-based, time matched nutrition education for PLWH control intervention (NC) equated for the offer of a tobacco quitline referral and 8 weeks of free nicotine patch for those who engage in quitline treatment, 2) to conduct a preliminary smoking cessation, randomized controlled trial (RCT) with 100 people living with HIV (PLWH) who smoke cigarettes, comparing CI-METQ vs. NC, with predictions that CI-METQ relative to NC will result in increased readiness, higher rates of tobacco treatment engagement, more quit smoking attempts and higher rates of 7-day point prevalence abstinence rates at 1-, 3- and 6-month follow-ups. Health-related quality of life over this period will also be examined, and 3) to examine CI-METQ's effects on key mechanisms during the computer session and their associations with tobacco treatment engagement and smoking outcomes at 1- and 3-month follow-ups. Detailed Description Cigarette smoking is now a leading cause of morbidity and mortality among people living with HIV (PLWH) engaged in highly active antiretroviral therapy (HAART) \[2-5\]. Between 40-70% of PLWH in the U.S. currently smoke \[6-14\], in comparison to 20.6% of the general population \[15\], and tobacco accounted for nearly 25% of all deaths in a multinational cohort of PLWH who used HAART \[2\]. PLWH who smoke are uniquely vulnerable, moreso than smokers without HIV, to developing cardiovascular \[2, 16\] and lung \[2, 17\] diseases, and also are at greater risk than non-smoking PLWH for a multitude of HIV-associated illnesses \[3, 5, 18, 19\]. Against this backdrop, HIV treatment providers acknowledge the importance of assisting PLWH with smoking cessation, but a significant proportion of them lack confidence, training, and/or time \[10, 12, 20\]. Very little research on smoking cessation interventions for PLWH has been published, and none has evaluated approaches that could be easily disseminated and integrated into standard HIV care. In this context, a sophisticated, efficacious \[ORs, 1.4-1.6 in meta-analyses \[21, 22\]\] tobacco quitline network is now available in every U.S. state via a national quitline portal, 1-800-QUIT-NOW and represents an untapped resource for PLWH. Notably, the most positive findings, to date, for smoking cessation in PLWH have involved telephone counseling delivered by clinical research staff \[1\], but no existing studies have reported on the efficacy of engaging PLWH with tobacco quitlines or on brief motivational approaches to facilitate this process. The long-term goal of this research program is to disseminate an effective, brief computer-based intervention that can be readily integrated into community-based, HIV treatment settings to motivate tobacco quitline use among smokers living with HIV. The overall objective of this application, which is the first step in the attainment of our long-term goal, is to develop this computer-based intervention, modify it based on initial piloting and feedback to insure its feasibility and acceptability, and obtain preliminary data supporting the efficacy of the intervention. The rationale for the proposed research is that many smokers living with HIV are interested in quitting smoking, and that by exploring their smoking-related concerns, providing feedback and enhancing self-efficacy, they can become motivated to engage in smoking cessation counseling, utilizing a no-cost, readily available treatment option-their local tobacco quitline. We plan to accomplish the objective of this application by pursuing the following three specific aims: 1. To develop a brief, computer-based intervention, the CI-METQ - Computer Intervention to Motivate Engagement in Tobacco Quitline treatment in PLWH who smoke. Also, to develop a computer-based, time matched nutrition education for PLWH control intervention (NC). 1a. Following the development of the prototype, we will conduct a preliminary pilot test of the CI-METQ with 8 smokers living with HIV, followed by in-depth interviews with each individual to develop an understanding of the strengths and limitations of the intervention. We will then utilize the interview feedback to guide the modification and refinement of the CI-METQ, after which we will repeat the process with another 8 smokers living with HIV. 1b. The data collected from these 16 interviews regarding feasibility, acceptability and barriers that would limit effectiveness will guide the investigators in making the appropriate modifications to finalize the CI-METQ prior to preliminary testing in a small, randomized controlled trial (RCT). 1c. A similar iterative process will occur with 4 PLWH who smoke in developing the NC condition. 2. To conduct a preliminary RCT with 100 smokers living with HIV, comparing CI-METQ to a computer-based, time matched nutrition control (NC) equated for the offer of a tobacco quitline referral and if engaged with quitline, 8 weeks of nicotine patch at no cost. We expect: 2a. CI-METQ relative to NC will result in increased readiness for smoking cessation post-intervention and higher rates of engagement in smoking cessation treatment. 2b. CI-METQ relative to NC will result in a greater proportion of participants making at least one 24 hour quit attempt over the six months post-intervention and in higher rates of 7-day point prevalence abstinence at 1-, 3- and 6- month follow-ups. 2c. To examine the effect of CI-METQ vs. NC on health-related quality of life over 6-month follow-up. 3. To explore potential mechanisms that may underlie the efficacy of CI-METQ: 3a. We will examine CI-METQ's effects on key mechanisms self-reported during the computer session: concerns about cigarette smoking, likelihood of reducing or quitting smoking, health benefits of quitting, and satisfaction with the brief intervention content. 3b. We will examine the associations of these dynamic changes with smoking cessation treatment engagement and smoking outcomes at 1-, 3- and 6-month follow-ups. With regard to expected outcomes, the work proposed in aims 1 - 3 is expected to result in the development of a brief, computer-based intervention that will produce preliminary data showing increased tobacco quitline utilization and smoking cessation in smokers living with HIV. Such results are expected to have an important positive impact, moving us closer to the long-term goal of dissemination and integration of a cost-effective, CI-METQ into community-based, HIV treatment settings, to motivate tobacco quitline use in PLWH who smoke. #Intervention - BEHAVIORAL : Brief Computer MI for Smoking Cessation - Brief computer MI intervention to motivate tobacco quitline use - BEHAVIORAL : Nutrition Control - Computer delivered nutrition education control condition

#Eligibility Criteria: Inclusion Criteria: * 18 - 70 years * current smoker (i.e., at least 10 cigarettes/day) * HIV seropositive * English speaking * reliable access to a telephone (own cellular phone or a landline in their home) * agreed to be available over the next 6 months. Exclusion Criteria: * cognitive impairment sufficient to impair provision of informed consent or study participation * current use of nicotine replacement therapy (NRT) or other pharmacotherapy for smoking cessation * use of other tobacco products Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01886924

{ "NCT_ID" : "NCT03547362", "Brief_Title" : "Real-time Amino Acid Profiling", "Official_title" : "Real-time Amino Acid Profiling", "Conditions" : ["Protein Digestion Kinetics"], "Interventions" : ["Dietary Supplement: Casein", "Dietary Supplement: Dairy protein blend 3", "Dietary Supplement: Dairy protein blend 1", "Dietary Supplement: Whey protein", "Dietary Supplement: Dairy protein blend 4", "Dietary Supplement: Dairy protein blend 2"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-05-30", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07-05", "Study_Completion_Date(Actual)" : "2018-07-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-04-20", "First_Posted(Estimated)" : 2018-06-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-05-23", "Last_Update_Posted(Estimated)" : 2018-07-11", "Last_Verified" : 2018-07" } }}

#Study Description Brief Summary This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population. #Intervention - DIETARY_SUPPLEMENT : Casein - See arm description - DIETARY_SUPPLEMENT : Dairy protein blend 1 - See arm description - DIETARY_SUPPLEMENT : Whey protein - See arm description - DIETARY_SUPPLEMENT : Dairy protein blend 2 - See arm description - DIETARY_SUPPLEMENT : Dairy protein blend 3 - See arm description - DIETARY_SUPPLEMENT : Dairy protein blend 4 - See arm description

#Eligibility Criteria: Inclusion Criteria: * Age >=65 and <=80 * BMI >=20 and <=32 kg/m2 * Non-smoking * Healthy as assessed by the NIZO lifestyle and health questionnaire ('Verklaring leefgewoonten en gezondheid') and according to the judgment of the study physician. * Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day) * Veins suitable for cannulation (blood sampling) * Voluntary participation * Having given written informed consent * Willing to comply with study procedures * Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years. * Accept disclosure of the financial benefit of participation in the study to the authorities concerned Exclusion Criteria: * Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 of this study * Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer * Use of the following medication: glucose lowering drugs, insulin; medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives) * Diagnosed with diabetes, being treated for high blood glucose or increased fasting blood glucose (> 7 mmol/l in finger prick blood) as assessed during screening visit * For men: Hb <8,5 mmol/l as assessed during screening visit; for women: Hb <7,5 mmol/l. * Use of protein supplements * Mental status that is incompatible with the proper conduct of the study * A self-reported reported food allergy or sensitivity to dairy ingredients * Alcohol consumption for men > 28 units/week and >4/day; for women: >21 units/week and >3/day * Reported unexpected weight loss or weight gain of > 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period * Reported slimming or medically prescribed diet * Recent blood donation (<1 month prior to Day 01 of the study) * Not willing to give up blood donation during the study * Personnel of NIZO food research and FrieslandCampina, their partner and their first and second degree relatives * Not having a general practitioner * Not willing to accept information-transfer concerning participation in the study, or information regarding his or her health, like laboratory results and eventual adverse events to and from his general practitioner Sex : ALL Ages : - Minimum Age : 65 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT03547362

{ "NCT_ID" : "NCT05467475", "Brief_Title" : "A Study in Healthy Men to Test How Esomeprazole Influences the Amount of BI 1819479 in the Blood", "Official_title" : "The Effect of Multiple Doses of Esomeprazole on the Single-dose Pharmacokinetics of BI 1819479 Following Oral Administration in Healthy Male Subjects (an Open-label, Randomized, Two-way Cross-over Study)", "Conditions" : ["Healthy"], "Interventions" : ["Drug: Esomeprazole", "Drug: BI 1819479"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-10-18", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-01-23", "Study_Completion_Date(Actual)" : "2023-01-23}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-07-18", "First_Posted(Estimated)" : 2022-07-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-07-18", "Last_Update_Posted(Estimated)" : 2023-01-26", "Last_Verified" : 2023-01" } }}

#Study Description Brief Summary The main objective of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of BI 1819479 in plasma. #Intervention - DRUG : BI 1819479 - BI 1819479 - DRUG : Esomeprazole - Esomeprazole - Other Names : - Nexium®

#Eligibility Criteria: Inclusion Criteria: * Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests * Age of 18 <= age <= 55 (inclusive) * Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) * Signed and dated written informed consent in accordance with International Council for Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial Exclusion Criteria: * Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minutes (bpm) * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT05467475

{ "NCT_ID" : "NCT02642731", "Brief_Title" : "Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty", "Official_title" : "Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty- a Pilot Study", "Conditions" : ["Arthroplasty, Replacement, Knee", "Acute Kidney Injury"], "Location_Countries" : ["Finland"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12", "Study_Completion_Date(Actual)" : "2015-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-12-25", "First_Posted(Estimated)" : 2015-12-30" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-12-25", "Last_Update_Posted(Estimated)" : 2018-02-27", "Last_Verified" : 2018-02" } }}

#Study Description Brief Summary Sensitive renal markers have been studied abundantly in connection with open heart, liver and transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury in orthopaedic surgery. Detailed Description Acute renal deterioration is a serious adverse event in elective surgery. Serum creatinine based diagnostics of acute kidney injury may delay diagnosis and produce false negative results since serum creatinine is affected by diet, muscle mass, used hydration therapy. In recent times new markers have been developed and tested in order to find sensitive, fast and reliable marker of renal deterioration.

#Eligibility Criteria: Inclusion Criteria: * informed consent * allergy to NSAIDs Exclusion Criteria: * no informed consent Sex : ALL Ages : - Minimum Age : 50 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02642731

{ "NCT_ID" : "NCT03239171", "Brief_Title" : "Bioinformation Therapy for Lung Cancer", "Official_title" : "Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Lung Cancer", "Conditions" : ["Small-cell Lung Cancer"], "Interventions" : ["Device: Cancer ablation", "Drug: Life information rehabilitation therapy"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-09-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-09-02", "Study_Completion_Date(Actual)" : "2018-09-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-08-01", "First_Posted(Estimated)" : 2017-08-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-08-01", "Last_Update_Posted(Estimated)" : 2019-01-25", "Last_Verified" : 2017-08" } }}

#Study Description Brief Summary The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable lung cancer. Detailed Description By enrolling patients with unresectable lung cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS). #Intervention - DEVICE : Cancer ablation - Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound. - Other Names : - Cryoablation or irreversible electroporation - DRUG : Life information rehabilitation therapy - Each treatment: one bottle solution each day, consecutive 3 months, oral administration - Other Names : - "Qilisheng' Immunoregulatory Oral Solution

#Eligibility Criteria: Inclusion Criteria: * All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies * Body tumor 1 <= age <= 6, with at least one tumor length > 2 cm * KPS >= 70, lifespan > 6 months * Platelet count >= 80×109/L，white blood cell count >= 3×109/L, neutrophil count >= 2×109/L, hemoglobin >= 80 g/L Exclusion Criteria: * Patients with cardiac pacemaker * Patients with brain metastasis * Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03239171

{ "NCT_ID" : "NCT02184247", "Brief_Title" : "Bioavailability of Two Sustained-release Theophylline Products in Healthy Males", "Official_title" : "A Study to Compare the Bioavailability of Two Sustained-release Theophylline Products", "Conditions" : ["Healthy"], "Interventions" : ["Drug: anhydrous theophylline, 300 mg", "Drug: anhydrous theophylline, 350 mg"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "1998-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "1998-05", }, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-07-08", "First_Posted(Estimated)" : 2014-07-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-07-08", "Last_Update_Posted(Estimated)" : 2014-07-09", "Last_Verified" : 2014-07" } }}

#Study Description Brief Summary Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg theophylline anhydrous (sustained-release product) by comparing the rate and extent of absorption of theophylline based on both single and multiple-dose profiles. #Intervention - DRUG : anhydrous theophylline, 350 mg - Other Names : - Bronchoretard® - DRUG : anhydrous theophylline, 300 mg - Other Names : - Theo-Dur®

#Eligibility Criteria: Inclusion Criteria: * Healthy, non-smoking male subjects between 18 and 45 years * Body weight within 10% of the ideal weight according to the Body Mass Index (BMI) * Normal health based on medical history and findings within the range of clinical acceptability, in respect of the physical examination (including electrocardiogram and vital signs) and special investigations * Ability to comprehend and willingness to sign both statements of informed consent (for screening and study-specific procedures) Exclusion Criteria: * History of serious systemic or organ disease * A major illness during the 3 months before commencement of the study-related procedures * Significant physical or organ abnormality * History of hypersensitivity to theophylline or other xanthine derivatives * Use of any medication within 2 weeks before the first administration of study medication * Participation in another study with an experimental drug within 8 weeks before the first administration of study medication * Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system (for example chloramphenicol, which may cause bone marrow suppression) * Donation of blood during the 8 weeks before the first administration of study medication * History of, or current compulsive alcohol abuse (> 10 drinks per week), of regular exposure to other substance of abuse * Positive testing for HIV and hepatitis B antigens within the previous 3 months Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02184247

{ "NCT_ID" : "NCT03901066", "Brief_Title" : "Smoking Dependence and Periodontitis", "Official_title" : "Smoking Dependence (Fagerström) as a Relevant Indicator for Tobacco Related Studies in Periodontology.", "Conditions" : ["Smoking", "Periodontitis"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-09-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-07", "Study_Completion_Date(Actual)" : "2015-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-03-22", "First_Posted(Estimated)" : 2019-04-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-04-01", "Last_Update_Posted(Estimated)" : 2019-04-03", "Last_Verified" : 2019-04" } }}

#Study Description Brief Summary The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis Detailed Description The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis. The research question was ' How the Fagerström for nicotine dependence (FTND) and the number of cigarette cunsuption (NNC) are correlated to the severity of chronic periodontitis'? Thirty-four consecutive smoker patients presenting a chronic periodontitis were included in the study, and the smoking status was defined both by NCC and FTND. Periodontal clinical parameters were correlated with NCC and FTND. All the clinical periodontal parameters were recorded by a single periodontist (L.S). Periodontal assessments included: probing depth (PD), gingival recession (RD), clinical attachment level (CAL), bleeding on probing (BOP), plaque score index (PI), Furcation (Furc), tooth mobility and the percentage of sites of PD ≥ 6mm. A graduated manual periodontal probe was used to take measurements at the 6 sites of each tooth. BOP (%) and plaque score (%). All the participants of the study respected the following inclusion criteria: 1/ smoker patients aged of minimum 18 years old, 2/ chronic periodontitis, 3/ presence of a minimum of 6 teeth at each arch, 4/ a minimum of 6 teeth with pocket depth of 5 mm, 5/ signed the informed consent. The exclusion criteria were: 1/ aggressive periodontitis, 2/ diabetes, 3/ connective tissue disease, 4/ pregnancy, 5/ radio-therapy, 6/ chemotherapy, 7/ psychological disease, 8/ previous periodontal therapy. The patient smoking status was defined by FTND and NCC FTND scores were categorized in 3 groups * scores \< 4 for low nicotine dependence, * scores = 4-5 for moderate nicotine dependence * scores \> 5 for high nicotine dependence. The NCC s was classified in three levels of smokers as described in most of the periodontal studies: * Number of cigarette smoking ≤ 10 per day for low consumption * Number of cigarette smoking from 10 to 20 per day for moderate consumption * Number of cigarette smoking \> 20 per day for high cigarette consumption

#Eligibility Criteria: Inclusion Criteria: * smoker patients aged of minimum 18 years * chronic periodontitis * presence of a minimum of 6 teeth at each arch * a minimum of 6 teeth with pocket depth of 5 mm * signed the informed consent Exclusion Criteria: * aggressive periodontitis * diabetes * connective tissue disease * pregnancy * radio-therapy * chemotherapy * psychological disease * previous periodontal therapy. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT03901066

{ "NCT_ID" : "NCT06098638", "Brief_Title" : "Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women", "Official_title" : "Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women: A Randomized Clinical Trial", "Conditions" : ["Postpartum Weight Retention"], "Interventions" : ["Other: aerobic and resisted exercise for 12 weeks", "Other: Nutritional recommendation and Faradic stimulation program"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2023-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-07-31", "Study_Completion_Date(Actual)" : "2023-07-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-10-14", "First_Posted(Estimated)" : 2023-10-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-10-21", "Last_Update_Posted(Estimated)" : 2023-10-24", "Last_Verified" : 2023-10" } }}

#Study Description Brief Summary the aim of the study was to investigate the effect of aerobic and resisted exercise program on lipid profile and quality of life in overweight breastfeeding women. Detailed Description Although previous studies reported that exercise training during the postpartum period could improve the lipid profile and quality of life in overweight women and reduce the postpartum fatigue . None of them had investigated the effect of aerobic and resisted exercises on lipid profile and quality of life in overweight breastfeeding women.this trial will include 2 groups: Group (A): was consist of 27 overweight breastfeeding women, who received nutritional recommendation and faradic current stimulation for 20 min on abdominal surface 2 times per week for 12 weeks. Group (B): was consist of 27 overweight breastfeeding women, who received the same nutritional recommendation and faradic current stimulation for 20 min on abdominal surface 2 times per week plus exercise training (aerobic + resisted) for 12 weeks. #Intervention - OTHER : Nutritional recommendation and Faradic stimulation program - proper maternal nutrition and fluid intake during breast-feeding per day for 12 weeks and2 sessions per week, each session 20 minutes, for 12 weeks. Frequency of 65 Hz, and width pulse 300 ms, with contraction time 10 sec and relaxation time 10 sec - OTHER : aerobic and resisted exercise for 12 weeks - Each woman in group (B) participated in a moderate exercise program (aerobic+resistive), 3 days/week, for 12 weeks. The session began with 15 minutes of aerobic exercise on a bicycle ergometer, at 60% of heart rate reserve (HRR), with HRR estimated (220-age-resting heart rate). Then, the participant was performed 15 minutes of resistive exercise (two sets of 8-12 repetitions at 75% of one repetition maximum (1-RM) for basic core exercises in the form of hip lifts, knee extension and flexion, crunches, shoulder flexion and extension, elbow flexion and extension with resistance

#Eligibility Criteria: Inclusion Criteria: * All of women were sedentary, non-smoking, breastfeeding women at their 3rd to 6th months postpartum * they had delivered a single, healthy, mature fetus with no complications through normal vaginal delivery. * Their age was ranged from 20 <= age <= 30 old. * Their parity number was one or two. * They were overweight (body mass index (BMI) was ranged from 25 to 30 kg/m²). Exclusion Criteria: * Having chronic disorders, heart disease, respiratory infections, diabetes mellitus, pelvic abnormalities, hormonal abnormalities, psychological problems, menstrual disorders or anemia of other pathological origins. * Receiving any type of physical exercise or sport. * Following a specific diet program. Sex : FEMALE Ages : - Minimum Age : 20 Years - Maximum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT06098638

{ "NCT_ID" : "NCT00890565", "Brief_Title" : "Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)", "Official_title" : "A Single-Blind, Randomized, Parallel Trial to Define the ECG Effects of Sancuso® (Granisetron Transdermal System) Compared to Placebo and Moxifloxacin in Healthy Men and Women", "Conditions" : ["Healthy"], "Interventions" : ["Drug: granisetron"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-08", "Study_Completion_Date(Actual)" : "2009-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-04-29", "First_Posted(Estimated)" : 2009-04-30" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-04-29", "Last_Update_Posted(Estimated)" : 2024-06-17", "Last_Verified" : 2024-06" } }}

#Study Description Brief Summary This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to placebo and moxifloxacin in healthy subjects. Detailed Description Granisetron is a well tested and established 5-HT3 receptor antagonist used in both oral and intravenous (IV) forms. A transdermal form of granisetron (Sancuso®) was approved by the United States (US) Food and Drug Administration (FDA) in September 2008. Many of the 5-HT3 antagonists were developed and approved before the adoption of the International Conference on Harmonisation (ICH) E14 standard on QTc and cardiac testing. The association of non-cardiac medicinal products with the potential to prolong the QT interval and induce torsades des pointes (TdP) has significant implications for the future development of medicinal products. #Intervention - DRUG : granisetron - Treatment A: Sancuso® patch (3.1mg/24 hours) on Day 1 and IV placebo (0.9% saline) on Day 3 Treatment B: Granisetron IV 10 mcg/kg over 30 seconds on Day 1 and placebo patch on Day 3 Treatment C: Placebo patch on Day 1 and IV placebo on Day 3 Treatment D: 400 mg oral moxifloxacin on Day 1 and placebo patch on Day 3 - Other Names : - Granisetron Transdermal System, Sancuso® patch, Kytril®, Granisetron Injection, IV Placebo (0.9% saline), Placebo patches, Avelox® Oral

#Eligibility Criteria: Inclusion Criteria: * Healthy male or female subjects * Aged between 18 and 50 years, inclusive, at screening * BMI between 18.0 and 32.0 kg/m², inclusive Exclusion Criteria: * History of drug abuse * Known hypersensitivity to granisetron, moxifloxacin, or related compounds, such as ciprofloxacin and levofloxacin * Sustained supine systolic blood pressure >140 mmHg or <100 mmHg or a diastolic blood pressure >95 mmHg at Screening or baseline * Pulse rate at rest of < 45 bpm or > 100 bpm * Abnormal Screening ECG indicating a second- or third degree AV block, or one or more of the following: QRS >120 milliseconds (ms); QTcF > 430 (males) or 450 (females) ms; PR interval >240 ms; any rhythm, other than sinus rhythm, interpreted to be clinically significant by the Investigator * Known history of long-QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, chest pain or dyspnea on exertion * Electrolyte disturbances (such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, hypocalcemia, or hypophosphatemia), idiopathic cardiomyopathy, unexplained syncope, hypertrophic cardiomyopathy, or sudden unexplained death at a young age (< 40 years) in a first-degree relative. * Has used any medications or consumed any foods contraindicated in the protocol. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT00890565

{ "NCT_ID" : "NCT03007394", "Brief_Title" : "Lorcaserin in the Treatment of Cocaine Use Disorder", "Official_title" : "Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder", "Conditions" : ["Cocaine-Related Disorders"], "Interventions" : ["Drug: Lorcaserin", "Drug: Placebo Oral Capsule"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-12-19", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-01", "Study_Completion_Date(Actual)" : "2019-12-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-12-21", "First_Submitted_that_Met_QC_Criteria" : 2020-06-02", "First_Posted(Estimated)" : 2017-01-02" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-12-28", "Last_Update_Posted(Estimated)" : 2020-08-05", "Last_Verified" : 2020-02" } }}

#Study Description Brief Summary The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder. Detailed Description This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3 weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week follow-up period, with scheduled visits during Study weeks 14 and 16. #Intervention - DRUG : Lorcaserin - Lorcaserin Capsule - Other Names : - Belviq, lorcaserin hydrochloride - DRUG : Placebo Oral Capsule - sugar pill to mimic lorcaserin 10mg capsule

#Eligibility Criteria: Inclusion Criteria: * Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured Clinical Interview for DSM-5 * Is seeking treatment for cocaine use disorder * Is able to understand and provide written informed consent * Has used cocaine on at least 1 day in the last 30 days prior to screening * Has completed all psychological assessments and procedures during the screening period * If female, not pregnant, lactating, unable to conceive OR must agree to use an acceptable method of birth control * Has a total body weight greater than 110 pounds and body mass index greater than 20 Exclusion Criteria: * Contact site for more information Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT03007394

{ "NCT_ID" : "NCT02215018", "Brief_Title" : "Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers", "Official_title" : "Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 5 - 800 mg). A Double-blind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Study, Including Re-dosing at 100 mg and 500 mg (Solution) and at 200 mg (Four 50 mg Tablets)", "Conditions" : ["Healthy"], "Interventions" : ["Drug: BI 44370 TA solution", "Drug: Placebo tablet", "Drug: BI 44370 TA tablet", "Drug: Placebo solution"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-08", }, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-08-12", "First_Posted(Estimated)" : 2014-08-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-08-12", "Last_Update_Posted(Estimated)" : 2014-08-13", "Last_Verified" : 2014-08" } }}

#Study Description Brief Summary To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI 44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further doses. #Intervention - DRUG : BI 44370 TA solution - DRUG : BI 44370 TA tablet - DRUG : Placebo solution - DRUG : Placebo tablet

#Eligibility Criteria: Inclusion Criteria: * Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR, RR and body temperature), 12-lead ECG, clinical laboratory tests * Age >=21 and Age <=50 years * Body Mass Index (BMI) >=18.5 and BMI <=29.9 kg/m2 * Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation Exclusion Criteria: * Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR), Respiratory rate (RR) , body temperature and Electrocardiogram(ECG)) deviating from normal and of clinical relevance * Any evidence of a clinically relevant concomitant disease * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Surgery of the gastrointestinal tract (except appendectomy) * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * History of relevant orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections * History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) * Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial * Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial * Participation in another trial with an investigational drug within two months prior to administration or during the trial * Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) * Inability to refrain from smoking on trial days * Alcohol abuse (more than 60 g/day) * Drug abuse * Blood donation (more than 100 mL within four weeks prior to administration or during the trial) * Excessive physical activities (within one week prior to administration or during the trial) * Any laboratory value outside the reference range that is of clinical relevance * Inability to comply with dietary regimen of trial site * A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms); * A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) * Not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake Sex : MALE Ages : - Minimum Age : 21 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02215018

{ "NCT_ID" : "NCT04310696", "Brief_Title" : "Comparison of Buteyko Technique and Pursed Lip Breathing in Asthma", "Official_title" : "Comparison of Buteyko Breathing Technique and Pursed Lip Breathing to Improve Pulmonary Function in Asthma", "Conditions" : ["Asthma"], "Interventions" : ["Other: Pursed lip breathing", "Other: Buteyko Breathing exercises"], "Location_Countries" : ["Pakistan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-08-30", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-02-15", "Study_Completion_Date(Actual)" : "2019-08-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-03-06", "First_Posted(Estimated)" : 2020-03-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-03-12", "Last_Update_Posted(Estimated)" : 2020-03-17", "Last_Verified" : 2020-03" } }}

#Study Description Brief Summary The objective of the study was to compare the effects of Buteyko breathing technique and pursed lip breathing technique in the management of asthma. A randomized controlled trial was conducted on 60 asthmatic patients randomly allocated to Buteyko technique group and pursed lip breathing group. Both the groups received 4 weeks of treatment, 3 times per week. Data was collected at base line, 2nd week and 4th week. Outcome measurements included FVC, FEV, PEFR and Asthma Control Test Questionnaire scores. Data analysis was carried out on Statistical Package for the Social Sciences (SPSS) v.21.0. Confidence interval was kept at 95% and a p-value of less than 0.05 was considered significant. Detailed Description Asthma is an inflammatory condition in which narrowing and swelling of the airways occur, accompanied with extra mucus production. This results in difficulty in breathing and triggers coughing, wheezing and dyspnea. In some cases asthma is a minor irritation, but on the other end of the spectrum it may interfered with activities of daily living and can even become life threatening in severe asthma attacks. According to a study conducted in Pakistan, the prevalence of asthma in adults was found to be 10.8% in adults, working in tanneries with 5.3% of them reporting their symptoms to be work related. Non-pharmacological management of asthma includes patient education, guidance and physiotherapy. It is suggested that physical therapy may have positive effects in patients with asthma, as they possess dysfunctional breathing patterns accompanied with poor physical condition. Numerous reviews by Cochrane have been published in the recent years regarding the effects of physical therapy in patients with asthma, focusing on the effects of numerous techniques including Alexander technique, manual therapy, physical training, breathing exercises and inspiratory muscle training. In terms of specific effects of different physical therapy treatment techniques in patients with asthma, in light of the existing literature, breathing exercises have found to improve quality of life, reduce symptoms of anxiety, depression and hyperventilation, and decrease respiratory rate and medication use. Moreover, inspiratory muscle training is found to improve symptoms, decrease medication use and also improve inspiratory pressure. Buteyko technique is a specialized breathing technique developed to reduce chronic hyperinflation. A pre and post design quasi experimental study conducted was conducted in 2014 to determine the effects of Buteyko breathing technique on asthma control and QOL in school aged children with asthma where Buteyko breathing technique group showed significant improvements terms of asthma control and quality of life. Based upon the review of the literature, evidence is inadequate in terms of comparison of Buteyko breathing technique with pursed lip breathing technique in the management of patients with asthma except for a single randomized controlled trial. For this reason the purpose of the current study is to compare the effects of Buteyko technique with pursed lip breathing in the management of patients with asthma. #Intervention - OTHER : Buteyko Breathing exercises - Buteyko breathing technique was performed by asking the patient to take a small breath in and then out and hold his/her breath and count the time in seconds, as long as he or she can, until first signs of air hunger start to appear, followed by normal breathing once again. This procedure was repeated 15 times, three sets of 15 repetitions were given to the patient per day, 3 days per week and the treatment was continued for 4 weeks. - OTHER : Pursed lip breathing - Pursed lip breathing was performed as nasal inspiration followed by expiratory blowing against partially closed lips. Participants received a total of 3 sets of 15 repetitions per day, 3 times a week and the treatment was continued for 4 weeks.

#Eligibility Criteria: Inclusion Criteria: * Patients categorized as mild to moderate persistent asthma category according to the 'National Asthma Education and Prevention Program' Exclusion Criteria: * Use of oral steroids within the four-week run-in period, * Change in inhaled steroid dose and type, * Other significant unstable medical conditions, * They have undertaken Buteyko breathing technique previously. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT04310696

{ "NCT_ID" : "NCT03799614", "Brief_Title" : "Vibration Impact on Parkinson's Tremor", "Official_title" : "Vibration Impact on Parkinson's Tremor", "Conditions" : ["Parkinson Disease"], "Interventions" : ["Device: RMBand lower dose", "Device: RMBand higher dose"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-02-26", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-11-27", "Study_Completion_Date(Actual)" : "2019-11-27}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-12-19", "First_Submitted_that_Met_QC_Criteria" : 2020-11-19", "First_Posted(Estimated)" : 2019-01-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-01-07", "Last_Update_Posted(Estimated)" : 2020-12-17", "Last_Verified" : 2020-11" } }}

#Study Description Brief Summary The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson's disease (PD). Detailed Description Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling. #Intervention - DEVICE : RMBand lower dose - Light-weight portable device that delivers low dose vibration to the arm - DEVICE : RMBand higher dose - Light-weight portable device that delivers higher dose vibration to the arm

#Eligibility Criteria: Inclusion Criteria: * Parkinson's disease (PD) as diagnosed by a movement disorder specialist * Tremor caused by their Parkinson's disease * Ability to provide informed consent Exclusion Criteria: * Known diagnosis of Parkinson Plus Syndrome * Dementia * Other known non-PD cause of tremor * Other known non-PD cause of limb dysfunction * Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus * Non-English speaker * Prisoners * Pregnant women Sex : ALL Ages : - Minimum Age : 21 Years - Maximum Age : 95 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03799614

{ "NCT_ID" : "NCT05511818", "Brief_Title" : "Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes", "Official_title" : "Radicle™ Rest: A Randomized, Blinded, Placebo-controlled, Direct-to-consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes", "Conditions" : ["Sleep", "Sleep Disturbance", "Sleep Disorder"], "Interventions" : ["Dietary Supplement: Rest Study Product Usage"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-09-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-31", "Study_Completion_Date(Actual)" : "2023-04-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-08-10", "First_Posted(Estimated)" : 2022-08-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-08-22", "Last_Update_Posted(Estimated)" : 2023-11-22", "Last_Verified" : 2023-11" } }}

#Study Description Brief Summary A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes Detailed Description This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for better sleep, (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption will be excluded. Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study. #Intervention - DIETARY_SUPPLEMENT : Rest Study Product Usage - Participants will use their Radicle Rest study product as directed for a period of 4 weeks.

#Eligibility Criteria: Inclusion Criteria: * 21 years and older * Resides in the United States * Endorses a desire for better sleep * Selects sleep as a primary reason for taking a cannabinoid product * Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks) * Expresses an interest in taking a study product and not knowing the product identity until the end of the study Exclusion Criteria: * Pregnant, trying to become pregnant, or breastfeeding * Reports a diagnosis of liver disease * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Unable to read and understand English * Lack of reliable daily access to the internet * Reports taking any medication that warns against grapefruit consumption Sex : ALL Ages : - Minimum Age : 21 Years - Maximum Age : 105 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT05511818

{ "NCT_ID" : "NCT02636842", "Brief_Title" : "A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder", "Official_title" : "A Phase 1, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole Lauroxil Following Administration to the Deltoid or Gluteal Muscle in Adults With Schizophrenia or Schizoaffective Disorder", "Conditions" : ["Schizophrenia", "Schizoaffective Disorder"], "Interventions" : ["Drug: Aripiprazole Lauroxil"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-06", "Study_Completion_Date(Actual)" : "2016-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-12-18", "First_Posted(Estimated)" : 2015-12-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-12-21", "Last_Update_Posted(Estimated)" : 2016-07-14", "Last_Verified" : 2016-07" } }}

#Study Description Brief Summary The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder. #Intervention - DRUG : Aripiprazole Lauroxil - Intramuscular (IM) injection, single dose - Other Names : - ARISTADA TM

#Eligibility Criteria: Inclusion Criteria: * Has a diagnosis of chronic schizophrenia or schizoaffective disorder * Has demonstrated ability to tolerate aripiprazole * Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening * Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive * Additional criteria may apply Exclusion Criteria: * Is pregnant, is planning to become pregnant, or is currently breastfeeding * Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine * Is a danger to himself/herself at screening or upon admission * Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Has a positive urine drug screen at screening or Day 1 * Additional criteria may apply Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02636842

{ "NCT_ID" : "NCT02386839", "Brief_Title" : "Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)", "Official_title" : "Long-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated With rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care", "Conditions" : ["Retinopathy of Prematurity (ROP)"], "Interventions" : ["Drug: rhIGF-1/rhIGFBP-3"], "Location_Countries" : ["Sweden", "Poland", "Netherlands", "United States", "Italy", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-03-26", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-09-28", "Study_Completion_Date(Actual)" : "2021-09-28}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-03-04", "First_Submitted_that_Met_QC_Criteria" : 2022-03-25", "First_Posted(Estimated)" : 2015-03-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-03-06", "Last_Update_Posted(Estimated)" : 2022-05-18", "Last_Verified" : 2022-04" } }}

#Study Description Brief Summary The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784). Detailed Description Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP) #Intervention - DRUG : rhIGF-1/rhIGFBP-3 - Participants who received 'rhIGF-1/rhIGFBP-3' in study ROPP-2008-01 (NCT01096784) will be enrolled to this study. No investigational product will be administered in this study. - Other Names : - Mecasermin rinfabate

#Eligibility Criteria: Inclusion Criteria: * Participant was randomized in Study ROPP-2008 <= age <= 01 Section D (NCT01096784). * Participants parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. Study-related activities are any procedures that would not have been performed during normal management of the participant. Exclusion Criteria: * Any other condition or therapy that, in the Investigator's opinion, may pose a risk to the Participant or interfere with the participants ability to be compliant with this protocol or interfere with the interpretation of results. * The participant or participants parent or legally authorized representative(s) is unable to comply with the protocol as determined by the Investigator. Sex : ALL Ages : - Minimum Age : 40 Weeks - Maximum Age : 108 Weeks - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT02386839

{ "NCT_ID" : "NCT02172989", "Brief_Title" : "Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.", "Official_title" : "Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.", "Conditions" : ["Benign Breast Neoplasm"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-04", "Study_Completion_Date(Actual)" : "2015-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-06-23", "First_Posted(Estimated)" : 2014-06-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-06-23", "Last_Update_Posted(Estimated)" : 2015-06-19", "Last_Verified" : 2015-06" } }}

#Study Description Brief Summary Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization. In this study, our hypothesis are as following: 1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. 2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer. Detailed Description Indocyanine green, ICG (ICG-fluorescence) * ICG is the most commonly used fluorophore which approve by FDA. * NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion * Contains sodium iodide, patients who have history of allergy to iodides should be used as caution. Nonpalpable benign brest lesion localization * New method for the localization and resection of non-palpable breast lesions. * The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

#Eligibility Criteria: Inclusion Criteria: * nonpalpable benign breast lesion <= 2cm in patients with breast cancer. * patients who need breast biopsy as treatment for breast cancer. * Eastern Cooperative Oncology Group Performance status 0 or 1 * consented patients with more than 20 years, less than 70 years Exclusion Criteria: * nonpalpable benign breast lesion >= 2cm in patients with breast cancer. * pregnancy * history of severe allergy to ICG(Indocyanine Green) * iode hypersensitiveness Sex : FEMALE Ages : - Minimum Age : 20 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02172989

{ "NCT_ID" : "NCT00855660", "Brief_Title" : "Effect of Riociguat on Bone Metabolism", "Official_title" : "Investigation of the Effect of Riociguat, Administered as 2.5 mg IR-tablets TID Over 14 Days, on Bone Metabolism in a Randomized, Placebo-controlled, Double-blind, 2-fold Cross-over Design in Healthy Male Subjects", "Conditions" : ["Pharmacology, Clinical"], "Interventions" : ["Drug: Placebo", "Drug: Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-12", "Study_Completion_Date(Actual)" : "2010-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-03-03", "First_Posted(Estimated)" : 2009-03-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-03-03", "Last_Update_Posted(Estimated)" : 2016-01-11", "Last_Verified" : 2016-01" } }}

#Study Description Brief Summary Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism. Detailed Description Clinical pharmacology #Intervention - DRUG : Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg - Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days. - DRUG : Placebo - Placebo administered as a single tablet, thrice daily, over 14 days.

#Eligibility Criteria: Inclusion Criteria: * Healthy male white subjects * 18 <= age <= 45 of age * BMI between 18 and 28 kg/m2 * Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period Exclusion Criteria: * Relevant deviation from the normal range in the clinical examination; in clinical chemistry, hematology, or urinalysis * Resting heart rate in the awake subject below 45 BPM or above 90 BPM * Systolic blood pressure below 100 mmHg or above 145 mmHg * Diastolic blood pressure above 95 mmHg * Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for males * History of genetic muscle or bone disease of any kind * Completely sedentary or extremely fit subjects * Fractures in the preceding 12 months * Psychiatric diseases * History of peptic ulcers or relevant gastro-esophageal reflux disease * Subjects with hypersensitivity to the investigational drug riociguat or ranitidine, or to inactive constituents * Regular daily consumption of more than half a liter of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form, more than 1 L of xanthine-containing beverages, recent smoking history * Use of medication within the 2 weeks preceding the study which could have interfered with the investigational drug riociguat or ranitidine * Subjects with a medical disorder, condition or history of such that would have impaired the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT00855660

{ "NCT_ID" : "NCT01324336", "Brief_Title" : "Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets", "Official_title" : "Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets", "Conditions" : ["Acute Lymphoblastic Leukemia"], "Interventions" : ["Drug: 6-Mercaptopurine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-12", "Study_Completion_Date(Actual)" : "2013-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-03-25", "First_Posted(Estimated)" : 2011-03-29" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-03-28", "Last_Update_Posted(Estimated)" : 2021-01-05", "Last_Verified" : 2020-12" } }}

#Study Description Brief Summary The purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL). #Intervention - DRUG : 6-Mercaptopurine - 75 mg/m2/dose/day - Other Names : - 6-MP

#Eligibility Criteria: Inclusion Criteria: * Patients ages 4 <= age <= 17 years who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included. Exclusion Criteria: * Inability to have blood drawn for the screening lab tests * Received methotrexate or folate supplement within the last 24 hours * Pregnant or lactating females * Inability to swallow a pill * Hemoglobin less or equal to 8 gm/dl * Presence of significant co-morbid illness that makes child ineligible as deemed by the investigator * Weight < or = 16 kg Sex : ALL Ages : - Minimum Age : 4 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT01324336

{ "NCT_ID" : "NCT03224546", "Brief_Title" : "Cocaine Use Reduction and Health", "Official_title" : "Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use", "Conditions" : ["Cocaine Use Disorder"], "Interventions" : ["Behavioral: Contingency Management"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-09-15", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-01-15", "Study_Completion_Date(Actual)" : "2024-01-15}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-07-18", "First_Submitted_that_Met_QC_Criteria" : 2024-07-31", "First_Posted(Estimated)" : 2017-07-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-07-19", "Last_Update_Posted(Estimated)" : 2024-08-01", "Last_Verified" : 2024-07" } }}

#Study Description Brief Summary Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be used to change current accepted cocaine treatment endpoints and accelerate identification of therapies for cocaine use disorder. #Intervention - BEHAVIORAL : Contingency Management - Subjects will receive payments for providing cocaine negative urine samples.

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * Self-report of recent cocaine use verified by a cocaine-positive urine sample * Meet moderate-severe Cocaine Use Disorder Criteria * Seeking treatment for their cocaine use * Able to commit to 12-week intervention, plus 24-week follow up Exclusion Criteria: * History of serious physical or psychiatric disease (e.g., physical dependence on any drug requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, extreme hypersensitivity/allergy to candida yeast or similar products, severe diagnosis for other substance use disorder) that would interfere with study participation * Current physical or psychiatric disease that would interfere with study participation * Poor veinous access, precluding blood draws Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT03224546

{ "NCT_ID" : "NCT06110637", "Brief_Title" : "Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill", "Official_title" : "Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill", "Conditions" : ["Healthy Volunteers"], "Interventions" : ["Other: 'hard shoes' runners evaluation", "Other: 'Soft shoes' runners evaluation"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-06-15", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-15", "Study_Completion_Date(Actual)" : "2023-01-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-07-18", "First_Posted(Estimated)" : 2023-10-31" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-10-24", "Last_Update_Posted(Estimated)" : 2023-12-01", "Last_Verified" : 2023-11" } }}

#Study Description Brief Summary During running, each contact between the foot and the ground causes an impact. Ground reaction forces (GRF) are considered as an input into the musculoskeletal system. It involves a sudden deceleration in the lower limb packages (including muscles) which generates Soft-Tissue Vibrations (STV). The body is able to attenuate Soft-Tissue Vibrations (STV) but this capability decreases with fatigue. STV could be minimize by improving shoe midsole hardness. Detailed Description Only 4 studies have studied Soft-Tissue Vibrations (STV) with a distance not exceeding 10 km and without evaluating the potential influence of the shoe. Thus, the effects of shoe midsole hardness on Soft-Tissue Vibrations (STV) and neuromuscular fatigue at the end of an intense and/or long run remains unknown. The purpose is to compare two shoes whose only midsole hardness differs during a half-marathon on Soft-Tissue Vibrations (STV), neuromuscular fatigue and running kinetics. Maybe the shoe ensuring a better STV damping of the medial gastrocnemius muscle would reduce neuromuscular fatigue and improve comfort. #Intervention - OTHER : "hard shoes' runners evaluation - The 'hard shoes' runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated. - OTHER : "Soft shoes' runners evaluation - The 'soft shoes' runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated.

#Eligibility Criteria: Inclusion Criteria: * Endurance runners doing a long run of at least 20 km once a week. * Affiliated or beneficiaries of a social security plan. * Have freely given their written consent. * Not participating in a competition during the study period. * Shoe size 37 to 46 Exclusion Criteria: * Any subject who has been injured in the 3 months preceding the protocol * Any subject with chronic joint pathologies (e.g., repeated sprains, patellar or ligament problems) or cardiac pathologies. * Any subject with chronic or central neurological pathologies * Any subject participating at the same time in another medical interventional experiment * Any subject who has taken corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy). * Any subject deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation). * Any subject declaring to have taken products prohibited by the World Anti-Doping Agency Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT06110637

{ "NCT_ID" : "NCT00028197", "Brief_Title" : "Comparison of Externally and Self-Initiated Movements", "Official_title" : "Comparison of Externally and Self-Initiated Movements", "Conditions" : ["Healthy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2001-12", "Study_Completion_Date(Actual)" : "2005-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2001-12-17", "First_Posted(Estimated)" : 2001-12-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2001-12-17", "Last_Update_Posted(Estimated)" : 2008-03-04", "Last_Verified" : 2005-11" } }}

#Study Description Brief Summary This study will use magnetic resonance imaging (MRI) to investigate how the brain controls voluntary movements triggered by an external stimulus or self-initiated. Registered HCMS healthy normal volunteers may participate. They will complete a questionnaire and will have a medical history and brief physical examination. The study consists of two parts: 1) body movement training and 2) magnetic resonance imaging, as follows: Part 1 - Body movement training Participants will train to do three different body movements involving the hands and feet. The movements will either be self-initiated or in response to a stimulus, such as a visual or auditory trigger. Part 2 - Magnetic resonance imaging Participants will do one or more of the trained movements, with or without a triggering stimulus, during MRI scanning. MRI is a diagnostic procedure that uses a magnetic field and radio waves to produce images of brain structure and activity. For the procedure, the subject lies on a stretcher that is moved into the scanner-a cylinder containing a strong magnet. Earplugs are worn to protect the ears from loud thumping noises that occur with electrical switching of radio frequency circuits. Scanning time varies from 20 minutes to 2 hours, with most examinations lasting 1 to 1-1/2 hours. The subject can communicate with the staff person conducting the test at all times during the scan. A device compatible with magnetic resonance will be used to record the participant's body movements. The participant may be asked to push buttons of the device during the tasks. Detailed Description Voluntary movements are divided into two categories, one is externally triggered movement and the other is self-initiated movement. The underlying neural mechanisms in each movement have been investigated, but they are not fully understood. The present study is aimed to understand the neural mechanisms, especially aimed to find out the commonly devoted brain area for the categorized movements. By obtaining functional magnetic resonance imaging (fMRI) signals during triggered movement tasks designed from 3 input triggers of different modalities (visual, auditory, and somatosensory) and 3 output movements of different body parts (right hand, left hand, and right foot), we will determine the brain regions specially devoted for each input or output, and commonly devoted for triggered movements. By obtaining fMRI signals during spontaneous voluntary movement tasks designed from 3 output movements of the same body parts, we will determine the brain regions specially devoted for specific execution and commonly devoted for the voluntarily chosen movements.

#Eligibility Criteria: INCLUSION CRITERIA: Normal volunteers will be included. Normal volunteers will be recruited from people who are registered as HMCS Normal Volunteers. All subjects participating in MR studies should have a valid Clinical Center Medical Record Number. EXCLUSION CRITERIA: We will not scan pregnant women because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subjects of childbearing potential prior to functional MRI scan. If the result from a urine pregnancy test is not available for some reason, a medical doctor will judge based on the proper information prior to the scanning. Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT00028197

{ "NCT_ID" : "NCT05548920", "Brief_Title" : "Preoperative Ultrasound Guided Evaluation of SVC-CI and IVC -CI as Predictors of Hypotension After Induction of Anaesthesia in Major Onco-surgery", "Official_title" : "Preoperative Ultrasound Guided Evaluation of Subclavian Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index as Predictors of Hypotension After Induction of General Anesthesia in Major Onco-surgery", "Conditions" : ["Total Fluid Volume Decreased"], "Interventions" : ["Other: Ultrasound guided Superior Vena Cava Collapsibility Index", "Other: Inferior Vena Cava Collapsibility Index"], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-06-26", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-30", "Study_Completion_Date(Actual)" : "2023-01-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-09-14", "First_Posted(Estimated)" : 2022-09-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-09-21", "Last_Update_Posted(Estimated)" : 2023-01-18", "Last_Verified" : 2023-01" } }}

#Study Description Brief Summary Patients undergoing major Oncosurgeries are fluid deficit due to preoperative fasting , inadequate intake due to disease hence prone to development of hypotension after induction of general anaesthesia owing to vasodilatory effects of anesthetic induction agents. Investigators plan study to measure ultrasound guided Superior Vena Cava and Inferior Vena Cava collapsibility Index as predictors of hypotension after induction of General anaesthesia. Detailed Description Investigators plan prospective study , written informed will be taken from all included patients. In the OR 5 lead ECG, NIBP,SPO2 monitors will be attached , patients will be explained about Ultrasound imaging . Preinduction using SONOSITE EDGE II ultrasonography machine and placing high frequency linear array probe (6-13 Hz) beneath the middle of the clavicle aligned in deltopectoral groove to obtain short axis view of Subclavian/Infraclavicular axillary vein in B-Mode (2-D imaging). Doppler pulse waveform and minimum and maximum diameter measurements of SVC will be obtained in M-mode , both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will be calculated using the following equation SCV AV CI = (dSCV max- dSCV min)/ dSCV max ×100. A phased array or cardiac ultrasound probe (1-5Hz) will be placed in the subxiphoid window to view IVC at the junction of IVC with right atrium .Then the transducer will be adjusted to obtain the long axis view of IVC. Doppler pulse waveform will be obtained to ensure imaging of IVC and then in the M mode the minimum and maximum diameter measurements of IVC will be obtained both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will calculated using the following equation:IVC CI = (dIVCmax- dIVCmin )/ dIVCmax ×100 . In all the patients both SVC and IVC -CI will be calculated. All patients will receive standard General Anesthesia with IV Fentanyl 1-2 mcg/kg , Sleeping dose propofol , Atracurium 0.5mg/kg and orally placed Endotracheal tube.The heart rate (HR) and mean arterial pressure (MAP) will be recorded in two phases .Intraoperative hypotension (IOH) been defined as MAP\<60mmHg or \>30%decrease in MAP from baseline. 1. Post induction phase: Readings will be taken at 1 min intervals from the start of induction till intubation (upto 5 minutes) and 2. Post intubation phase: Readings will be taken at 2 min intervals upto 10 min and at 5 min intervals up to 30 mins or till incision . Each hypotensive episode encountered will be treated with leg lifting first (lifting both lower extremities for 2 minutes by technical staff) , if hypotension persists then IV Ephedrine 6 mg boluses will be given . All patients will receive preloading 200ml crystalloids prior to induction of anesthesia . #Intervention - OTHER : Ultrasound guided Superior Vena Cava Collapsibility Index - Preoperative Ultrasound guided Superior Vena Cava Collapsibility Index will be measured - OTHER : Inferior Vena Cava Collapsibility Index - Preoperative Inferior Vena Cava Collapsibility Index will be measured.

#Eligibility Criteria: Inclusion Criteria: * Patients belonging to ASA Grade I,II,III * For major Oncosurgery under general anaesthesia Exclusion Criteria: * Patient refusal * BMI>30 * Emergency surgery * Preoperative Hypotension MAP < 70 mmHg * LVEF<40% * Difficult Airway * Nasal Intubation * Inability to obtain good ultrasound images of SCV and IVC . Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05548920

{ "NCT_ID" : "NCT01348269", "Brief_Title" : "Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome", "Official_title" : "A Prospective, Bi-centric,Randomized, Primary Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome", "Conditions" : ["Bone Marrow Edema"], "Interventions" : ["Drug: Aclasta", "Drug: Placebo"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-08-26", "Study_Completion_Date(Actual)" : "2015-08-26}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-05-02", "First_Submitted_that_Met_QC_Criteria" : 2024-08-09", "First_Posted(Estimated)" : 2011-05-05" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-05-04", "Last_Update_Posted(Estimated)" : 2024-08-13", "Last_Verified" : 2024-08" } }}

#Study Description Brief Summary The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy. #Intervention - DRUG : Aclasta - 1 x intravenous non-current drip (infusion) - DRUG : Placebo - NaCl Solution

#Eligibility Criteria: Inclusion Criteria: * Men: age over >= 18 years or women: age over >= 18 years with finished reproductivity according to the following definition: * >= 12 month persistent natural (spontaneous) amenorrhoea (women aged <50: additionally: FSH >40MIE/ml and estrogen deficiency of <30pg/ml or a negative estrogen test) * status post hysterectomy and / or bilateral oophorectomy * finished reproduction planning * secure diagnosis of bone marrow edema using MRT * current osteologic basic laboratory values (<= 4 weeks before V2) according to DVO criteria * presence of an personally signed informed consent for the participation in the study Exclusion Criteria: * - subchondral bone loss or already occurred cartilage damage due to the bone marrow edema * reactive bone marrow edema with advanced arthrotic changes in the adjacent joint (grade III and IV according to Kellgren and Lawrence) * patients with edematous changes in bone marrow due to the diagnosis of M. Sudeck / algodystrophy / Complex Regional Pain Syndrome (CRPS) * patients with known hypo- and hyperparathyroidism, osteogenesis imperfecta, osteomalacia, M. Paget or another systemic skeletal diseases, except osteoporosis * patients with bone necrosis in the painful skeletal region * patients with infectious process at the affected bone or the adjacent joint and adjacent soft parts, respectively * patients with diagnosed or assumed rheumatoid arthritis, Lupus erythematodes, collagenosis or vasculitides * patients with advanced renal insufficiency (GFR according to Cockcroft / Gault <= 40 ml/min/KO) * patients with malignant diseases with osseous manifestation in anamnesis/history * status post malignant basic/primary disease with large dosed chemotherapy * current or massive dose therapy completed before less than 6 weeks (>7.5mg prednisolon equivalent) with glucocorticoids * patients with a malignant tumor disease within the past 5 years, independent from the affected organ system and independent from the implemented treatment, the presence of a relapse or metastatic invasion, except basal cell carcinoma and squamous-cell carcinoma of the skin Current treatment due to uveitis * vague/ambiguous hyper- or hypocalcemia, hyper- or hypophosphatemia * etiological vague/ambiguous AP-increase * symptomatic renal calculus or nephrocalcinosis within 2 years before V2 * recent fracture within the last 3 months independent of the localisation * non consolidated fractures * previous treatment with i.v. bisphosphonates within the last 12 months * previous treatment with oral bisphosphonates within the last 12 months and longer than 3 months * pre-treatment with prostacyclin analogs (Ilomedin® / Iloprost®) within the past 6 months * Current treatment due to inflammatory diseases of the jaw area as well as planned tooth extractions or tooth extractions less than 6 months ago or oral surgery implant treatment * pregnancy or nursing period * patients immediately involved in the conduction of the trial and relatives * patients with current proceedings related to the bone marrow edema * patients for which the participation in the study carries an increased risk under consideration of the health condition due to the assessment of the investigator * participation in another clinical trial within 30 days before study start or during the trial * participation of patient who might be dependent on the investigator, also the spouse, parents or children Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01348269

{ "NCT_ID" : "NCT02376348", "Brief_Title" : "Male Circumcision Against HIV Hukomboa", "Official_title" : "Increasing Uptake of Voluntary Medical Male Circumcision Among Men Aged 20-34 Years in Njombe & Tabora Regions, Tanzania: A Cluster Randomised Controlled Trial", "Conditions" : ["HIV"], "Interventions" : ["Behavioral: A targeted demand creation Activities"], "Location_Countries" : ["Tanzania"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-02-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-05-04", "Study_Completion_Date(Actual)" : "2017-02-28}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-02-24", "First_Posted(Estimated)" : 2015-03-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-03-02", "Last_Update_Posted(Estimated)" : 2017-10-06", "Last_Verified" : 2017-10" } }}

#Study Description Brief Summary Tanzania launched a National Strategy for scaling-up voluntary medical male circumcision in 2010, and aims to circumcise 2.8 million males by 2015. In September 2009, Jhpiego's Maternal and Child Health Integrated Program (MCHIP) launched a PEPFAR-funded voluntary medical male circumcision (VMMC) program which has circumcised over 110,000 males in Njombe and Iringa regions by June 2012. In line with the national strategy, the target age for the program was 10-34 years, but 80% of clients were aged 10-19 years. There is an urgent need to increase the proportion of older men (aged 20 years and above) who become circumcised, to have greatest impact on the HIV epidemic. Detailed Description In order to maintain high client flow in sites, the Iringa service delivery model is flexible in terms of how, where and when services are delivered. Approaches include: i) Static sites: These sites offer regularly scheduled VMMC services several days a week. Services are offered year round rather than periodically. Volume tends to be low (20-50 clients a week). ii) Outreach sites: VMMC services are offered periodically at health facilities. A team composed of providers 'borrowed' from other regional health facilities visits the sites for a 2-3 week period and offers VMMC 6 days a week. This is typically a high volume setting, in which 40-120 circumcisions are performed a day, depending on the number of beds which can be set up. iii) Campaign: Campaigns happen 2-3 times a year, and may include both static and outreach sites. Campaigns are high volume, concerted approaches to VMMC where multiple facilities are running coordinated VMMC service delivery. These services are complemented by demand creation activities (mass media, interpersonal activities and outreach activities) designed to recruit and motivate new clients, and a text messaging information system which is advertised through radio and other means, providing potential clients advice on where VMMC is offered, the benefits of VMMC, and post-surgery reminders for wound care, follow-up visits and safer sex. The intensity of the demand creation depends on the size of campaign. In general, static sites do not have any demand creation but outreach and campaigns do. The proposed research will take place at outreach sites; however, the study will not stop on-going VMMC services provided at static sites to young men but rather encourage older males to come as well as young boys. Outreach sites have larger potential client size than static sites because the catchment area round the outreach sites have generally not had access to VMMC in the past and clients show up in large numbers to be served, whereas in static sites, clients trickle through in lower volume. Outreach activities can be scheduled at the convenience of the program. By using outreach activities, the proposed research, can be more easily scheduled into the study's data collection timeframe (compared to campaign sites which are on a highly prescribed schedule). QUALITATIVE ASSESSMENT FINDINGS In February 2011, Jhpiego co-investigators on this study conducted qualitative research in 3 districtsin Iringa (Iringa Municipality, Njombe and Mafinga), with the aim of understanding men's and women's views on appropriate age for circumcision, perceptions on circumcision, barriers and facilitators to older men seeking circumcision, and seasonality\[9\]. Identified barriers among older men included shame associated with older men getting circumcised, as it was seen to be an age-inappropriate activity, concerns of older men about their partners being faithful to them during the healing period, concerns about loss of income during the healing period, and concern around erections causing damage to the penis or delay wound healing. The facilitating factors included that circumcised men were seen as cleaner, safer from diseases, and more sexually desirable to women. Exploration of preferences for service delivery showed that participants had a strong preference for a model in which boys and men were provided separate services. There was also support for all-male service providers to alleviate concerns about embarrassment at having women view/touch the penis and the possibility that an erection could occur during the procedure. There was little support for including female partners accompanying their partners to the facilities. There was a marked preference for the cold season (June-August) for three reasons: fewer farming responsibilities, school being out, and a cold temperature which is perceived to facilitate wound healing. Based on this research, we anticipate that the targeted VMMC strategy evaluated in this research will include demand-creation strategies using focused informational communication messages for men aged over 20 years, and increased information and education for female partners. Service delivery strategies may include separate services for men versus boys and increasing the role of male service providers. The targeting strategy will be finalised during Study 1, and implemented and evaluated during Study 2. #Intervention - BEHAVIORAL : A targeted demand creation Activities - Sites randomized to the intervention arm will receive all activities in the control arm, plus additional demand-creation communication messages that focus on the non-HIV benefits of VMMC and the voluntary nature of HIV testing prior to VMMC ii) use of already circumcised men from the community as auxiliary peer promoters, iii) separate waiting and group education areas for men aged 20 years and above during service delivery, iv) engagement of female partners in community-based demand creation and education and counselling about wound healing and post-circumcision abstinence.

#Eligibility Criteria: Inclusion Criteria: Sites * an outreach VMMC health facility, * a site selected by Jhpiego for outreach VMMC campaign, * a site that has not had previous outreach services (to enable the results to be generalizable to future new outreach) or have not had VMMC outreach services in the previous 6 months, and * physically distant from other potential study sites to minimise contamination (spill over) of activities in the intervention communities into control communities. The parent sites from different clusters must be at least 20km away from each other, regardless of whether they are randomised to be control or intervention sites. Clients * Uncircumcised males * given an informed consent to participate in the study Exclusion Criteria: 1) Circumcised males Sex : MALE Ages : - Minimum Age : 10 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT02376348

{ "NCT_ID" : "NCT02323386", "Brief_Title" : "Kinematic Analysis of a PS, FB Primary Total Knee Arthroplasty (ATTUNE Knee System) Using Dynamic RSA", "Official_title" : "Anatomo-functional Correlation Between Intra-operative Passive Kinematics Recorded by Navigation and Post-operative Kinematics Analyzed by Dynamic Weight Bearing RSA of the Operated Knee.", "Conditions" : ["Osteoarthritis"], "Interventions" : ["Device: Primary Total Knee Arthroplasty (ATTUNE Knee System)"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-07", "Study_Completion_Date(Actual)" : "2016-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-12-10", "First_Posted(Estimated)" : 2014-12-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-12-22", "Last_Update_Posted(Estimated)" : 2018-05-14", "Last_Verified" : 2018-05" } }}

#Study Description Brief Summary Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per year. Statistics indicate that for patients over 60 year old approximately one out of 20 will require corrective reoperations within 10 years after surgery. However, for patients younger than 60 years, approximately one out of 10 will require revision total knee arthroplasty within 10 years of surgery. As the number of younger patients is increasing, there has been a shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and implant longevity being the important issues for quality of patient care. Furthermore, it has been reported that up to 25% of patients are not satisfied with the functional results of their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However these are often static, because of even most advanced x-ray film exchanger limit the number of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction. The purpose of this study is to investigate the effect of a new implant design on the post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A prospective randomized study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis. Detailed Description The main goal of this study is to investigate the effect of a new implant design on the postoperative active knee kinematics on mid-flexion instability of the joint. Data will be collected during the surgery with a Computer Assisted Surgery system and in the post operative follow up phase using the dynamic RSA focusing. A prospective study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis. Kinematic tests will be performed to analyze femoral rotation patterns and translation patterns of the medial and femoral condyle respect to the tibial plateau during different daily life motor tasks. Despite reportedly good implant survival rates, not all patients are fully satisfied after total knee arthroplasty (TKA). One of the most debated topics in TKA is the effectiveness of the prosthesis to reproduce physiological kinematics at the replaced knee, usually expressed in terms of patterns of joint rotation in the three anatomical planes, of the functional axis, and of the tibio-femoral contact points on the medial and lateral condyles, that is, femoral roll-back. Implant design can influence final kinematic results. The mid-flexion instability may be the cause of joint instability, paradoxical femoral rollback, surgical variation. Recently an improved implant design of fixed bearing PS DePuy implant has been anticipated to early users. This implant has been claimed to reduce midflexion instability and improve joint kinematics, because of a particular multiradius shape of the condylar surface. For intra-operative kinematic acquisition, a commercial navigation system (BLUIGS, Orthokey Italia srl, Firenze, Italy) with a dedicated software for kinematic tests will be used. In the present study, the investigators will use a postoperative bi-planar imaging method in weight-bearing motor tasks with active muscle contraction , to determine the in vivo contact areas on the tibial articulating surface of a PS TKA during flexion of the knee. The objective of the present study is to determine the contact areas and their movement through a 0-140° arc of motion in both the anteroposterior (AP) and ML directions. The cohort will also be compared with data of normal knee kinematics, as reported in current literature. At 6 months follow-up, dynamic fluoroscopy will be used to analyze implant kinematics (i.e. stair descent, level-walking and non weight-bearing maximum knee flexion) and a simultaneous, real-time collection of ground reaction forces with a force platform will be performed. Clinical scores will be collected at that time and compared with all the data registered before surgery and during the follow up routinely made at 1 and 3 months after surgery. A specifically developed device installed at the Rizzoli Orthopaedic Institute will be used to assess the kinematic of the knee at 9 months after surgery. This equipment is unique worldwide: it was specifically designed, built and certified for dynamic and static RSA evaluation of TKA. The purpose of this study is to investigate the effect of a new implant design on the post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A prospective randomized study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis. #Intervention - DEVICE : Primary Total Knee Arthroplasty (ATTUNE Knee System) - The patient will undergo primary Total Knee ArthroplastY use ATTUNE Knee System. During surgery a navigation system will be used to record preoperative joint kinematics under different tests. During the test the 6 degrees of freedom (DOF) of the joint will be computed and shown to the surgeon; these are the femoral rotation and translation pattern against flexion ranges. Navigation system will be also used to monitor the implant positioning and possible surgical bias. Dynamic RSA will be used to analyze the in vivo kinematics of the prosthesis at 6 months follow-up. The above mentioned motion tests will be performed 3 times. The first 2 will be executed to gain comfort with the experimental set-up with no X-ray exposure. During the last data is collected.

#Eligibility Criteria: Inclusion Criteria: * Severe radiographic osteoarthritis (Kellgren-Lawrence grade >3) * Patients scheduled for a primary TKA * Willing to take part in study and providing HIPAA authorization Exclusion Criteria: * Previous corrective osteotomy on the affected lower limb * Post-traumatic arthritis * Severe preoperative valgus deformity (Hip Knee Ankle angle>10°) * BMI>40 kg/m2 * Rheumatoid arthritis * Chronic inflammatory joint diseases * Patients with a pre-pathological abnormal gait (amputated, neuromuscular disorders, poliomyelitis, developmental dysplasia of the hip) * Severe ankle osteoarthritis (Kellgren-Lawrence>3) * Severe hip osteoarthritis (Kellgren-Lawrence>3) * Previous total hip or ankle replacement * Unwilling to take part in study and providing HIPAA authorization Sex : ALL Ages : - Minimum Age : 50 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02323386

{ "NCT_ID" : "NCT02696252", "Brief_Title" : "G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator", "Official_title" : "Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator", "Conditions" : ["Diabetes Mellitus"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-04", "Study_Completion_Date(Actual)" : "2016-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-01-25", "First_Posted(Estimated)" : 2016-03-02" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-02-25", "Last_Update_Posted(Estimated)" : 2016-04-14", "Last_Verified" : 2016-04" } }}

#Study Description Brief Summary Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator Detailed Description The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.

#Eligibility Criteria: Inclusion Criteria: * Ages >= 2 years * Diagnosis of Type 1 diabetes or Type 2 diabetes * Willing to participate in a clinic session involving venous sampling for evaluation of study end point Exclusion Criteria: * Use of acetaminophen * Known allergy to medical-grade adhesives * Pregnancy * Hematocrit outside specification of the study-assigned blood glucose meter Sex : ALL Ages : - Minimum Age : 2 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT02696252

{ "NCT_ID" : "NCT00044551", "Brief_Title" : "Evaluation of Bay 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma", "Official_title" : "An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma", "Conditions" : ["Lymphoma, Non-Hodgkin"], "Interventions" : ["Drug: Taxane (Cytotoxic, BAY59-8862)"], "Location_Countries" : ["France", "Netherlands", "United States", "Germany", "Canada", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2002-02", "Study_Completion_Date(Actual)" : "2003-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2002-08-30", "First_Posted(Estimated)" : 2002-09-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2002-09-03", "Last_Update_Posted(Estimated)" : 2013-10-14", "Last_Verified" : 2013-10" } }}

#Study Description Brief Summary Almost two-thirds of lymphoma cases are Non-Hodgkin's Lymphomas (NHL). NHL is a malignant process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence and mortality rates from NHL are highest in developed countries. While many patients with aggressive NHL are curable with initial anthracycline-containing regimens, the majority of patients will relapse or prove refractory to initial therapy. The prognosis of patients with disease recurrence following a multidrug regimen is also limited. The current protocol is designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive Refractory Non-Hodgkin's Lymphoma. #Intervention - DRUG : Taxane (Cytotoxic, BAY59-8862) - Daily 1 h infusion every 3 weeks

#Eligibility Criteria: Inclusion Criteria: - Measurable disease as defined by the presence of at least one measurable lesion - Failed at least one prior therapy or has achieved remission but has progressed or relapsed within 6 months of therapy - Life expectancy of at least 12 weeks - Adequate bone marrow, liver and kidney function Exclusion Criteria: - Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - Others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00044551

{ "NCT_ID" : "NCT03215433", "Brief_Title" : "Study of Biomarkers of the Response to Biotine", "Official_title" : "Single-centre, Observational Study, Concerning Blood-lipid Biomarkers of the Response to Treatment With Biotine, Prescribed in the Context of a Nominative TAU (Temporary Authorized Use) in Patients With an Inactive Progressive Form of Multiple Sclerosis (MS).", "Conditions" : ["Multiple Sclerosis", "Biotine"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-12-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-01-23", "Study_Completion_Date(Actual)" : "2019-01-23}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-06-26", "First_Posted(Estimated)" : 2017-07-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-07-10", "Last_Update_Posted(Estimated)" : 2019-09-18", "Last_Verified" : 2019-09" } }}

#Study Description Brief Summary Biotine is proposed by neurologists to patients with a progressive form of Multiple sclerosis (MS) in the context of a nominative temporary authorization for use (TAU) as a disease-modifying treatment for their MS. A recent study showed that with this treatment, more patients experienced an improvement after one year in comparison with patients given a placebo. The objective of this study is to identify blood biomarkers to determine good responders as early as possible. In addition, the blood parameters studied will make it possible to better understand the mechanisms of action, that have a beneficial effect on multiple sclerosis. The management of patients will not be modified: same number of consultations (at the prescription, at 3 months, at 12 months), same clinical examination, and the same number of blood samples (at the prescription, at 3 months, and at 12 months).

#Eligibility Criteria: Inclusion Criteria: * 18 <= age <= 65 old * inactive progressive form of MS according to the Lublin classification and recorded in the Burgundy EDMUS database * Patients with health insurance cover * Patients who have provided written informed consent (OFSEP) Exclusion Criteria: * Patients unable to understand the information sheet * Patients with remittent or active progressive MS * Patients with a change in the disease-modifying treatment within the previous 3 months * Patients treated with corticosteroids in the month before inclusion * Impossibility to provide patients with the necessary information * Patients in custody * Patients under guardianship Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03215433

{ "NCT_ID" : "NCT03404115", "Brief_Title" : "A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease", "Official_title" : "A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects With Dry Eye Disease", "Conditions" : ["Dry Eye Syndrome"], "Interventions" : ["Drug: Reproxalap Ophthalmic Solution (0.1%)", "Drug: Vehicle Ophthalmic Solution", "Drug: Reproxalap Ophthalmic Solution (0.25%)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-01-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07-11", "Study_Completion_Date(Actual)" : "2018-07-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-01-12", "First_Posted(Estimated)" : 2018-01-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-01-12", "Last_Update_Posted(Estimated)" : 2019-07-16", "Last_Verified" : 2018-01" } }}

#Study Description Brief Summary A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease #Intervention - DRUG : Reproxalap Ophthalmic Solution (0.25%) - Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks. - DRUG : Reproxalap Ophthalmic Solution (0.1%) - Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks. - DRUG : Vehicle Ophthalmic Solution - Vehicle Ophthalmic Solution administered for approximately twelve weeks.

#Eligibility Criteria: Inclusion Criteria: * Be at least 18 years of either gender and any race; * Have a reported history of dry eye for at least 6 months prior to Visit 1; * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1; Exclusion Criteria: * Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; * Have used any eye drops within 2 hours of Visit 1; * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; * Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1; * Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1; * Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1; Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03404115

{ "NCT_ID" : "NCT00097656", "Brief_Title" : "MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk", "Official_title" : "MOTOR: Maternal Oral Therapy to Reduce Obstetric Risk", "Conditions" : ["Pregnancy Related", "Periodontitis", "Premature Birth"], "Interventions" : ["Other: multi-center, randomized, controled periodontal therapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2004-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-03", "Study_Completion_Date(Actual)" : "2010-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2004-11-24", "First_Posted(Estimated)" : 2004-11-25" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2004-11-24", "Last_Update_Posted(Estimated)" : 2018-01-29", "Last_Verified" : 2018-01" } }}

#Study Description Brief Summary The purpose of this study is to determine whether maternal periodontal therapy (tooth cleaning) decreases the rate of preterm deliveries at \<37 weeks gestation and to determine the effects of maternal periodontal therapy on the birth weight of infants born less than 37 weeks gestation. Detailed Description STUDY DESIGN: The intervention is designed as a multi-center, randomized, controlled, clinical trial to determine the effects of periodontal therapy on the rate of preterm birth. Study participants will be assigned to one of two study arms. All pregnant women who present to the designated Obstetrical (OB) clinics are potential subjects for this study. A total of 1800 patients will be enrolled at 3 performance sites, enrolling about 600 subjects at each site at a rate of about 171 subjects/year at each site, randomly assigning these subjects to one of 2 treatment arms. Randomization will be performed using a computer-generated assignment scheme designed and performed in a masked manner by the data coordinating center. Each performance site will enroll about 300 subjects into each treatment group using the intent-to-treat principle, obtaining follow-up on all subjects. In treatment Group 1 participants will be assigned to standard localized periodontal therapy of scaling and root planning with subgingival polishing between three and six months of gestation. Group 2 will receive the same local periodontal therapy immediately following delivery. MASKING: The dental examiner will not be aware of the randomization treatment assignments of participants until after a complete baseline periodontal examination has been conducted. The study protocol allows the dental examiner to know the treatment assignment of participants but this knowledge will not affect the assessment of the primary obstetric outcome of the study. OB personnel or individuals collecting OB data will be masked as to dental treatments. At delivery the second dental exam will be made without the examiner knowing the pregnancy outcome. PRIMARY/SECONDARY OUTCOME MEASURES: The primary outcome is preterm delivery at less than 37 weeks gestational age, as determined by ultrasound dating. Secondary outcomes include (1) preterm delivery less than 35 weeks, (2) weight for gestational age, and (3) neonatal morbidity/mortality. It is our central hypothesis that mothers with periodontitis that receive periodontal treatment during the second trimester of pregnancy will experience a lower rate of preterm delivery at \<37 weeks and secondarily \<35 weeks; that periodontal treatment of these pregnant mothers will result in an increase in the weight for gestational age of deliveries occurring less than 37 weeks gestational age and reduce neonatal morbidity and mortality. We will determine the effects of periodontal therapy on the rate of preterm birth at GA\<37 weeks as the principal outcome and on mean birth weight among neonates with GA\<35 weeks, as a secondary outcome adjusting for race, gender and gestational age. POTENTIAL CONFOUNDERS AND COVARIATES: There are many potential risk factors that relate to preterm birth and growth restriction that need to be considered in this investigation. There are also exposures, effect modifiers and covariates that influence periodontal disease status and preterm birth. Data will be collected on the major variables of interest to include race, age, smoking, previous preterm delivery, first births, bacterial vaginosis, chorioamnionitis, sexually transmitted diseases (STDs), antibiotic usage, socioeconomic status (SES) and substance abuse. In addition we will measure fetal fibronectin and collect vaginal smears to examine for potential subclinical vaginosis. Detailed information will be collected on these potential factors and used to assure that randomization has effectively balanced risk between treatment arms and to permit post-hoc assessments. PLAN FOR MONITORING: There will be an administrative Steering committee consisting of the Obstetric and Periodontal Principal Investigator(PI) from each clinical site, the NIDCR co-investigators and the Data and Statistical Coordinating Center (DSCC) investigators. The Steering committee will meet twice the first year and once a year thereafter. Study coordinators will also attend one of the two annual meetings. Data will be collected on dental, obstetric and neonatal outcomes by the data \& statistical coordinating center, monitoring weekly for adverse events. The DSCC will be collating adverse events and safety data centrally to provide safety assessment reports to the DSMB. The DSMB will monitor outcomes and adverse events and assure maternal and infant safety and provide feedback to NIDCR every 6 months or as needed. ADVERSE EVENTS: The dental examiner will conduct a comprehensive oral soft tissue (cancer screening) and periodontal examination at baseline and at post partum. Following enrollment mothers will be followed up by, OB surveillance through parturition, a post-delivery dental follow-up and neonatal surveillance that includes chart review after discharge. All of these provide an opportunity to detect and monitor adverse events. All reported and observed serious adverse events will be documented on an adverse event case report form describing the onset, duration, severity, assessment of causality and relationship to treatment intervention. This will be followed until resolution. A member of the investigative team will review subject's OB charts on a weekly basis to note any adverse events or treatment provided (outside of routine). In addition all neonatal discharge summary findings will be collected to monitor any adverse neonatal morbidity such as neonatal sepsis and necrotizing enterocolitis. Any dental treatment will be noted in the subject's clinical record to be reviewed by the dental examiner. PLAN FOR DATA ANALYSIS: The details of the analysis plan appear in the body of the protocol, and are summarized here. The incidence of preterm birth as the principal outcome will be evaluated using a chi-square test. Approximately 240 cases are expected at gestational age (GA)\<35 weeks. Success of randomization for possible confounders will be evaluated by logistic regression models. Significance will be indicated by an alpha level of 0.05. Mean birth weight among preterm babies will be analyzed for correlations and significant differences between study arms using a non-parametric test (Kruskal-Wallis test) Parametric (regression) models will be used to adjust for gestational age and other factors.\]. Analyses will be conducted using the intent to treat philosophy. Data will be collected on a series of potential risk factors, covariates, confounders and effect modifiers that may influence the primary and secondary outcomes or periodontal status. Any unbalanced distribution of risks or exposures will be included in the regression model analysis. Adverse event data will be reported regularly. Interim analyses for efficacy will be conducted after 600 and 1200 completed pregnancies. #Intervention - OTHER : multi-center, randomized, controled periodontal therapy - periodontal therapy - Other Names : - Periodontal Therapy

#Eligibility Criteria: Inclusion Criteria: * Willing to be randomized and complete treatment protocols and provide informed consent * Planning on prenatal care and delivery at the enrollment center * Pregnant and able to complete periodontal treatment prior to 236 weeks gestation * At least 16 years at enrollment * Minimum of 20 teeth present * Three (3) or more periodontal sites with > 3mm clinical attachment loss Exclusion Criteria: * Multiple gestation * Positive history of HIV infection, AIDS, autoimmune disease, or diabetes (gestational diabetes is acceptable) * Any medical contraindication to periodontal probing or periodontal treatment that would require antibiotic prophylaxis, (e.g., congenital heart disease, use of Phen- fen for weight loss without a clear Sex : FEMALE Ages : - Minimum Age : 16 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT00097656

{ "NCT_ID" : "NCT02472795", "Brief_Title" : "Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus", "Official_title" : "A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus", "Conditions" : ["Systemic Lupus Erythematosus"], "Interventions" : ["Drug: Matching placebo", "Drug: Cenerimod"], "Location_Countries" : ["Ukraine", "Georgia", "United States", "Russian Federation", "Bulgaria", "Belarus"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-06-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-01-23", "Study_Completion_Date(Actual)" : "2017-02-28}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-05-14", "First_Submitted_that_Met_QC_Criteria" : 2020-02-12", "First_Posted(Estimated)" : 2015-06-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-06-12", "Last_Update_Posted(Estimated)" : 2020-02-26", "Last_Verified" : 2020-02" } }}

#Study Description Brief Summary International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients. Detailed Description This multicentre, double-blind, placebo-controlled study will have a staggered approach (Part A and B). In part A, eligible patients will be randomly assigned (1:1:1:1) to once daily oral administration of cenerimod (0.5, 1, 2 mg) or placebo. After all patients have completed 4 weeks of treatment during part A, an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B. In part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo. All participants will receive study medication for 12 weeks. #Intervention - DRUG : Matching placebo - One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning). - Other Names : - Placebo - DRUG : Cenerimod - One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning). - Other Names : - ACT-334441

#Eligibility Criteria: Inclusion Criteria: * Male and female participants aged 18 <= age <= 65 with established SLE. Participants must have active SLE, Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of at least 2 points for musculoskeletal or mucocutaneous manifestations and history or presence at screening of positive anti-nuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies. * Enrolled participants must be treated with background SLE medications. Exclusion Criteria: * Participants with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, infection and infection risks, history or presence of malignancy, history or presence of bone marrow or solid organ transplantation) or lactating or pregnant women. * Participants with severe SLE disease or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02472795

{ "NCT_ID" : "NCT05284578", "Brief_Title" : "The Effects of Expressive Writing and Compassionate Letter Writing on Emotional Distress Intolerance", "Official_title" : "The Effects of Expressive Writing and Compassionate Letter Writing on Emotional Distress Intolerance: A Brief Randomized Controlled Trial", "Conditions" : ["Distress Intolerance"], "Interventions" : ["Other: Self-compassionate writing intervention", "Other: Expressive writing intervention", "Other: Control writing task"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-07-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-07-21", "Study_Completion_Date(Actual)" : "2022-07-21}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-03-08", "First_Posted(Estimated)" : 2022-03-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-03-16", "Last_Update_Posted(Estimated)" : 2022-09-08", "Last_Verified" : 2022-09" } }}

#Study Description Brief Summary Perceived emotional distress intolerance is a transdiagnostic marker of psychopathology associated with psychological and interpersonal dysfunction, and the development of interventions for perceived emotional distress intolerance is of prime importance. One potential intervention is a behavioural experiment, i.e. a cognitive behaviour therapy technique where clients undergo an exercise designed to test a maladaptive belief, e.g., that negative emotions are unbearable, and adjust their belief to accommodate any disconfirmatory information that arises through the exercise. This study examines the effects of a one-session self-compassion writing behavioural experiment compared to a one-session expressive writing behavioural experiment on low perceived distress tolerance. Participants were recruited from the University of Waterloo and Prolific, and were randomly assigned to the self-compassion condition, expressive writing condition, or a control condition. Detailed Description The study consisted of two online surveys. During the first survey, participants answered a set of questionnaires. Then, they were prompted to think of an upsetting situation and the associated unpleasant emotions, and they were then randomly assigned to a brief self-compassionate writing, expressive writing, or neutral writing task. They then answered a series of questionnaires immediately after completing the writing task. During the second survey, one week later, participants answered a brief set of questionnaires. #Intervention - OTHER : Self-compassionate writing intervention - Participants assigned to this intervention were asked to engage in one brief online self-compassionate writing session, where they were asked to write about and experience their feelings from the perspective of an inner compassionate observer. - OTHER : Expressive writing intervention - Participants assigned to this intervention were asked to engage in one brief online expressive writing session, where they were asked to explore their deepest thoughts and emotions surrounding an upsetting situation through writing. - OTHER : Control writing task - Participants assigned to this condition were asked to engage in a neutral time management writing task.

#Eligibility Criteria: Inclusion Criteria for University of Waterloo sample: * Undergraduate students with a SONA account who are high in emotional distress intolerance (i.e. a lower-than-average score on the Distress Tolerance Scale; mean based on SONA student sample) Inclusion Criteria for Prolific sample: * Adults with a Prolific account who are high in emotional distress intolerance (i.e. a lower-than-average score on the Distress Tolerance Scale; mean based on Prolific sample) * First language English speakers Exclusion Criteria: * None Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT05284578

{ "NCT_ID" : "NCT03910868", "Brief_Title" : "Impact of P-gp, MRP2, ENT-1 and CNT3 on the Blood Concentration / Intra-PBMC Concentration of Tacrolimus", "Official_title" : "Study of the Impact of P-gp, MRP2, ENT-1 and CNT3 on the Blood Concentration / Intra-PBMC Concentration of Tacrolimus in Liver and Kidney Transplant Patients", "Conditions" : ["Liver Transplantation", "Kidney Transplantation"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-07-16", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-16", "Study_Completion_Date(Actual)" : "2020-12-16}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-04-04", "First_Posted(Estimated)" : 2019-04-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-04-09", "Last_Update_Posted(Estimated)" : 2021-01-13", "Last_Verified" : 2021-01" } }}

#Study Description Brief Summary Prospective and monocentric pharmacokinetic study Detailed Description Membrane transporters supporting tacrolimus at the lymphocyte level may play a role in the variability of the relationship between tacrolimus blood concentration and intracellular concentration, or may be the main explanatory factors. Nevertheless, most of the studies carried out on the subject, have been by genetic approach, neglecting in fact the membrane expression of these transporters, which could testify more to the real effect on the transport of tacrolimus. A better understanding of the cellular transport mechanisms of tacrolimus in the T lymphocyte could thus make it possible to identify sub-populations of patients under-exposed at the intra-lymphocyte level, despite satisfactory systemic exposure.

#Eligibility Criteria: Inclusion Criteria: * Adult of 18 or over; * fully and honestly informed, and not having reported his non-opposition to the use of his samples for research; * Affiliated to a social security scheme; * Hepatic and / or renal transplant stable between two and twenty-four months after transplantation, treated with tacrolimus; * Without modification of immunosuppressive treatment or treatment likely to modify their pharmacokinetics (imidazoles, macrolides ...) during the last two weeks; * Each patient can only be included once. Exclusion Criteria: * Participation in another protocol whose procedures are incompatible with the realization of the study; * Pregnant woman ; * Major person subject to legal protection (safeguard of justice, guardianship, tutorship); * Person deprived of liberty; * Opposition to the use of clinical data and remnants of samples taken from care for research purposes. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03910868

{ "NCT_ID" : "NCT01994603", "Brief_Title" : "Expansion to Interdisciplinary HIV Prevention in Women", "Official_title" : "Preventing FAS/ARND in Russian Children/Expansion to Interdisciplinary HIV Prevention in Women", "Conditions" : ["HIV", "AIDS", "Fetal Alcohol Syndrome", "Alcohol Related Neurodevelopmental Disorder"], "Interventions" : ["Behavioral: Opt-in or Opt-out testing", "Behavioral: Focus Group"], "Location_Countries" : ["Russian Federation", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-09", "Study_Completion_Date(Actual)" : "2015-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-10-23", "First_Posted(Estimated)" : 2013-11-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-11-19", "Last_Update_Posted(Estimated)" : 2016-01-14", "Last_Verified" : 2016-01" } }}

#Study Description Brief Summary This trial will pilot test intervention strategies to increase utilization of HIV testing and gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV sexual transmission in the general population in Russia. The study will assess whether external (cost, convenience) or internal factors (low perception of own risk, reluctance to identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested and if peer support impacts their decision. A randomized experimental manipulation, comparing opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed by a second-chance testing offer will be used to inform these questions. The answers will enable the international research team to engineer and then test an HIV testing promotion strategy in Russia. The project will collect preliminary data for a larger study to develop an evidence-based program to reduce the HIV transmission in this high risk population. Detailed Description A mixed methods research design combining qualitative and quantitative data collection methods will be used to increase the understanding of barriers to HIV testing, identify promising strategies to increase testing, generate research hypotheses, and design a future randomized clinical trial to evaluate HIV prevention targeted to at-risk women in the general population in Russia. The qualitative methods include structured interviews and a focus group participation to assess women's reasons for being the tested and possible prevention strategies. The quantitative methods include observation/recording of women's testing behaviors. #Intervention - BEHAVIORAL : Opt-in or Opt-out testing - Study participants will be offered a health screening onsite. - BEHAVIORAL : Focus Group - Study participants will be invited to participate in a focus group discussion.

#Eligibility Criteria: Inclusion Criteria: * A parent study participants who completed HIV risk survey and * Reported two or more partners in the last 12 months and no or inconsistent condom use in the last 3 months and no HIV testing in the last 12 months * Or reported any sexually-transmitted disease and no HIV testing in the last 12 months Exclusion Criteria: * A parent study participants who declined to be contacted for participating in future research studies Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 44 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT01994603

{ "NCT_ID" : "NCT04399655", "Brief_Title" : "Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients", "Official_title" : "Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients", "Conditions" : ["Chronic Renal Failure", "Renal Insufficiency, Chronic"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-11-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-06-04", "Study_Completion_Date(Actual)" : "2022-06-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-05-11", "First_Posted(Estimated)" : 2020-05-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-05-19", "Last_Update_Posted(Estimated)" : 2022-11-16", "Last_Verified" : 2022-06" } }}

#Study Description Brief Summary Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions. Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care. Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters. Nevertheless, there are no data on the medico-economic impact of such a program. Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology. The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.

#Eligibility Criteria: Inclusion Criteria: * Patient dependent on the CPAM Haute Garonne, * Patient affiliated to or beneficiary of a French social security scheme, * Haemodialysis patient for more than 12 months and in front of benefiting/benefiting from a physical activity program, * Patient age >= at 18 years, * French speaking patient. Exclusion Criteria: * Patient with cancer, hepatitis, stage 4 arterial disease, arteritis or amputation of a limb * Pregnant or breastfeeding women according to article L.1121 <= age <= 5 of the CSP, * Vulnerable persons according to article L.1121 <= age <= 6 of the CSP, * Persons of full age under guardianship or curatorship or under safeguard of justice, * Patient unable to personally give his or her consent, or age of majority protected by law, * Opposition expressed to inclusion in the study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04399655

{ "NCT_ID" : "NCT01318681", "Brief_Title" : "Rhinitis, Cognition and Driving Performance", "Official_title" : "Effects of Treated and Untreated Allergic Rhinitis on Mood, Cognitive Functions and Actual Driving Performance", "Conditions" : ["Seasonal Allergic Rhinitis", "Driving Ability", "Cognition"], "Interventions" : ["Drug: placebo", "Drug: fluticasone furoate", "Drug: cetirizine 10 mg"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-03", "Study_Completion_Date(Actual)" : "2012-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-03-17", "First_Posted(Estimated)" : 2011-03-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-03-17", "Last_Update_Posted(Estimated)" : 2013-11-08", "Last_Verified" : 2011-03" } }}

#Study Description Brief Summary This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from AR symptoms. We will compare the driving performance of untreated, symptomatic AR patients with the performance of symptomatic patients that have been treated with either a systemic AR medication (a pill) or a topical medication (nasal spray) #Intervention - DRUG : cetirizine 10 mg - cetirizine 10 mg over encapsulated - DRUG : fluticasone furoate - nasal spray 25ug per dose - DRUG : placebo - a placebo nasal spray and placebo capsule are available for double dummy treatment

#Eligibility Criteria: Inclusion Criteria: * Healthy volunteers known with Seasonal Allergic Rhinitis * Experienced drivers holding a license * 21- 45 years Exclusion Criteria: * Asthma or other chronic illness * current psychoactive medication * History of drug abuse Sex : ALL Ages : - Minimum Age : 21 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT01318681

{ "NCT_ID" : "NCT01744197", "Brief_Title" : "Synera Venipuncture Pain", "Official_title" : "Effect of Synera in Reducing Pain Associated With Venipuncture and Superficial Dermatologic Procedures", "Conditions" : ["Pain", "Phlebotomy", "Palliative Care"], "Interventions" : ["Drug: Synera (lidocaine 70mg/tetracaine 70mg)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-02", "Study_Completion_Date(Actual)" : "2013-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-12-04", "First_Submitted_that_Met_QC_Criteria" : 2016-01-20", "First_Posted(Estimated)" : 2012-12-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-12-04", "Last_Update_Posted(Estimated)" : 2018-10-25", "Last_Verified" : 2018-09" } }}

#Study Description Brief Summary Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended to reduce the pain associated with venipuncture and superficial dermatologic procedures by numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology patients undergoing venipuncture as part of their care, for treatment or diagnostics (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30 minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS #Intervention - DRUG : Synera (lidocaine 70mg/tetracaine 70mg) - All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second. - Other Names : - Synera

#Eligibility Criteria: Inclusion Criteria: * Patients with any tumor type where treatment is received through venipuncture or any procedure that is needle based or who require regular pharmacokinetic (PK) study. * Is 18 years or older. * Patients expected to undergo the first venipuncture procedure within 5 working days of enrollment. * Male or female patients * Has signed the most recent Patient Informed Consent Form * Has signed a Patient Authorization Form (HIPPA) Exclusion Criteria: * Patients with sensitivity to lidocaine, tetracaine, or any other component of the product * Known sensitivity to any components of test materials (sulphites and adhesives) * Patients with damaged or broken skin at the designated patch site * Pregnant or breastfeeding women patients * Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products containing acetaminophen or ibuprofen with one of these agents within 4 hours of the patient's visit * Previous irradiation to the site of the patch Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01744197

{ "NCT_ID" : "NCT03665792", "Brief_Title" : "The Correlation Between Sevoflurane and qNOX", "Official_title" : "The Prospective Observational Research of the Analgesic Effect of Sevoflurane and the Correlation Between Sevoflurane and qNOX", "Conditions" : ["Analgesic Adverse Reaction", "Nociceptive Pain", "Inhalation; Vapor"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-02-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-09-01", "Study_Completion_Date(Actual)" : "2019-09-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-08-04", "First_Posted(Estimated)" : 2018-09-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-09-08", "Last_Update_Posted(Estimated)" : 2020-01-22", "Last_Verified" : 2020-01" } }}

#Study Description Brief Summary This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the correlation between the sevoflurane and NOX index. Detailed Description This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the analgesia effect of the sevoflurane. And test the correlation between the sevoflurane and NOX index. #Intervention - DEVICE : nociception index qNOX - non-invasive, real time, monitoring for nociception stimulation - Other Names : - CON , BIS

#Eligibility Criteria: Inclusion Criteria: * Elective thoracoscope surgery patients * Age ranging from 25 <= age <= 85 * American Society of Anesthesiologists (ASA) Physical Status score of 2 to 4 * a body mass index (BMI) ranging from 18.5 to 40 kg/m2. Exclusion Criteria: * Clinical diagnosis of Alzheimer's Disease * implanted pacemaker * Clinical diagnosis of psychiatric diseases * Clinical diagnosis of epilepsy * Clinical diagnosis of autonomic nervous system disorders which might affect the EEG Sex : ALL Ages : - Minimum Age : 25 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03665792

{ "NCT_ID" : "NCT02569983", "Brief_Title" : "The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research", "Official_title" : "A Multi-centre Prospective Pilot Observational Cohort Study to Assess Quality of Life and Survival After Surgery for Advanced Ovarian Cancer", "Conditions" : ["Ovarian Neoplasms"], "Interventions" : ["Other: Observational cohort"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-01", "Study_Completion_Date(Actual)" : "2019-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-10-05", "First_Posted(Estimated)" : 2015-10-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-10-06", "Last_Update_Posted(Estimated)" : 2019-05-02", "Last_Verified" : 2018-10" } }}

#Study Description Brief Summary The primary aims of the SOCQER-2 study are to describe any impact on short (6 weeks), medium term (6, 12 months) and long term (18 months, 24 months) PRO/quality of life using validated questionnaires in patients undergoing standard or extensive surgery for suspected or confirmed Stage III/IV ovarian cancer and to describe progression free survival (PFS) in these patients. Detailed Description BACKGROUND The cornerstones of treatment for advanced ovarian cancer are surgical cytoreduction and systemic therapy. The aim of surgery is the maximal cytoreduction of all visible disease, ideally reaching a total macroscopic tumour clearance. Whilst most gynaecological oncologists accept that surgical procedures needed to achieve complete cytoreduction are on a continuum, a Cochrane review summarises types of ovarian cancer surgery as follows: * standard surgery * radical surgery * supra-\[ultra-\] radical surgery Several observational studies and two systematic reviews of non-randomised studies have shown an association between the amount of residual disease following surgery and survival, controlling for various confounding factors. However, the systematic reviews identified no randomised control trials directly comparing standard surgery versus extensive surgery. A National Institute for Health and Care Excellence (NICE) Interventional Procedures Overview found a number of retrospective observational studies comparing extensive with standard surgery, and found that women who underwent extensive surgery had better survival to those undergoing standard surgery, thus suggesting that the utilisation of surgical procedures to achieve complete cytoreduction may overcome disease aggressiveness. Incidence of serious complications, however, was higher in patients undergoing extensive surgery. However, there were several confounding factors e.g patients with good performance status are more likely to be selected to undergo extensive surgery. Equally, patients with lesser disease burden can have complete removal of tumour by standard surgery alone. A Cochrane review comparing outcomes from ultra-radical surgery versus standard concluded it was unclear whether there were differences in progression free survival, quality of life and morbidity, and that a randomised control trial with sufficient statistical power or well-designed non-randomised studies were needed. Equally important are outcomes other than survival that are valued by and very pertinent to patients and their carers. To date, there have been no methodologically robust studies evaluating Quality of life (Patient Reported Outcomes) in patients undergoing extensive surgery to achieve tumour clearance. Patient reported outcomes are multidimensional health related quality of life measurements. This study will builds upon a single site pilot study, evaluating short and medium term Patient reported Outcomes (PRO) at the Pan Birmingham gynaecological cancer centre. SOCQER-1 compared PRO Outcomes in 64 women with ovarian cancer, of whom 24 had extensive surgery; SOCQER-1 found no statistically significant difference in PRO in women undergoing standard or extensive surgery for ovarian cancer by 9 months postoperative period - however the limitations of a small sample size and a single centre study should be noted. SOCQER-2 will provide longer term PRO Outcomes and survival on a larger cohort undergoing extensive surgery and will capture variation in practice by centres. SOCQER-2 will provide good quality prospective evidence on the impact of extensive surgery on Quality of life and survival in patients with ovarian cancer in large, multiple UK gynaecological cancer centres. STUDY DESIGN Patients will be identified at MDT/at clinic and approached during subsequent contact. A team member from the participating centres will provide an information leaflet, explain and obtain informed consent. Sites have the option of sending patient information sheets by post and patients also have the option of consenting by post. This study is intended to be an exploratory study. The underlying hypothesis being tested is whether patients undergoing extensive surgery have a 13% reduction (considered clinically significant difference) in Quality of life as compared to patients with a similar cancer burden at 6 months postoperative timepoint that is balanced by a 4 month survival gain in patients in the extensive surgery group. The study is a prospective, multicentre observational cohort study. Clinical data will be captured prospectively using CRFs at baseline, surgery, postoperative and 18 months outcome. Patients will complete QoL questionnaires at 6 weeks, 6 months, 12 months, 18 months and 24 months postsurgery. For patients undergoing neoadjuvant chemotherapy, they will also complete a prechemo questionnaire SAMPLE SIZE As this study is intended to be 'exploratory', the investigators have aimed to calculate a minimal sample size, with an assumption of 2:1 recruitment in extensive surgery: standard surgery groups. A review of randomised control trials found that even quality of life was a primary endpoint, sample size was not always reported and that there was no consistent basis for these calculations. Analysis of repeated measures quality of life data should take account of missing data using an appropriate method for multiple imputation of missing items and an analysis that does not assume that data are Missing Completely at Random has been recommended. Therefore a mixed model is proposed for analysis of repeated measures data. Regarding sample size for repeated measures quality of life data, common practice is to pick a single time point and calculate sample based on a single difference in group means, inflating sample size for dropout. This gives a conservative estimate of sample size in most cases. This is the approach adopted here, as although sample size calculations based on repeated measures models can be more accurate, in this case this approach is unlikely to provide more accuracy, given uncertainties as to the final group sizes for this observational study. The investigators assume that there will be maximal quality of life difference at 6 months and expect on the basis of clinical estimates that the ratio of group sizes for very extensive v standard surgery of 2:1. The investigators have assumed p\<.05 and power of 80%. It has been suggested that an evidence based medium difference in the EORTC QLC 30 is 13 points. The mean score in stage II-IV ovarian cancer patients at baseline in the EORTC scoring manual is 56.3 (SD 24.5), while six month follow-up scores in a trial of neo-adjuvant versus primary de-bulking surgery was 73.1 (SD3.0) at six months in the primary surgery arm (n=201). The difference in Standard deviations may reflect the tight inclusion criteria for a randomised trial, and it might be assumed that in this observational study of surgical candidates would fall somewhere between the two figures. Assuming that QLC 30 at six months may be lower than this average those undergoing very extensive surgery at 66, but that the standard deviation is as reported in the scoring manual at 24 (likely to be a conservative assumption) and that a 13 point difference would be of clinical importance, a sample size of 123 (group 1=41 and group 2=82) would be required, with additional allowance for dropout or a comparable SD to that reported in the scoring manual (10 to 20 patients) (calculations made in Stata 13.1). In the single centre SOCQER study, baseline EORTC QLC30 mean scores were 58.33 (SD 21.6) in the standard surgery group (n=32) and 63.1 (SD 25.6) in the extensive surgery group, figures broadly in line with the EORTC manual. The maximum difference between groups was 6 points in favour of the extensive surgery group 6 weeks postsurgery with smaller differences in favour of the standard surgery group at 3, 6 and 9 months. Although these differences did not at any point reach the suggested level for an evidence based medium sized difference in quality of life, given this is a single centre study which may incur selection bias between groups and there were some differences in stage and residual disease between groups, a study powered detection of a medium sized, rather than a small difference remains appropriate. Standard deviations are higher in this study than in the Greimal trial which in part may result from sample variation. Symptom scores however did show some differences which did not reach statistical significance in a mixed model, with a score (higher =poorer outcome) of 35.0 (SD 17.0) in the extensive surgery group and 25.0 (SD 17) in the standard surgery group. While symptom score should be considered secondary to quality of life, a sample size of 129 on the same assumptions as above would be adequate to demonstrate this difference plus additional allowance for dropout. Although one approach to sample size calculations for subscales in RCTs involving quality of life outcomes is to adjust the alpha value to allow for multiple testing, in this observational study no further sample size calculations have been made as the investigators acknowledge that the purpose of analysis of subscale outcomes will be hypothesis generating. However, this sample size does not allow for subgroup analysis, known confounders, loss to follow-up, the additional heterogeneity from different patient populations and treatment policies in the multiple centres in the study and, in the case of propensity score analysis, loss of observations that cannot be matched during the propensity score matching stage. It therefore represents a minimum target not a maximum ceiling, and recruitment will continue for the full 12 month period. Recruitment of patients will take place over the course of 12 months. The high volume centres (\>40 ovarian cancer surgeries per year) conduct an average of 62 surgeries per year. STATISTICS All statistical analysis will be conducted in Stata 13. Differences between the 'extensive' and 'standard' groups for baseline variables will be compared using descriptive statistics and statistical tests appropriate for the level of measurement and sample distribution will be used. Outcome variables (composite quality of life and survival) for each of the groups will also be summarised using means or percentages as appropriate. For outcome- As this is an observational study, residual confounding cannot be ruled out, and reporting of results will acknowledge this. For the outcome variables measured at multiple time points (specifically patient-reported quality of life), measures at each time point will be described, and repeated measures models will be used to reduce the probability of type I errors. Imputation techniques will be used where data on quality of life or other outcome variables is missing. Propensity score analyses will also be considered if informative scores and adequate matching can be achieved. This observational study will provide information on current practice and outcomes that are likely to be used in national guidance, to inform future research and to provide information about previous patients experience to women undergoing ovarian cancer surgery; descriptive and exploratory analyses will be carried out to provide maximal information to inform policy and design future research. The investigators anticipate comparing QoL and other outcomes in three groups - women treated with standard surgery with no residual disease (less cancer load), those treated with standard surgery with residual disease (greater cancer load) and those with extensive surgery and no residual disease with greater cancer load and use of surgery with the aim of overcoming this). Descriptive analyses may include: * identify centres performing extensive surgery and the extent of surgery performed * associations of specific components of ovarian cancer surgery with different aspects of quality of life; * characteristics of patients undergoing 'extensive' and 'standard' therapy including performance status; * descriptions of postoperative quality of life which might indicate opportunities for intervention around specific morbidities or in supportive care with the potential to improve patient's quality of life. * Associations with PROMs. #Intervention - OTHER : Observational cohort - No intervention - observational study

#Eligibility Criteria: Inclusion Criteria: * Patients with suspected or confirmed ovarian cancer with macroscopic spread beyond the pelvis (FIGO stage III-IV), determined through pre-operative clinical assessment or imaging * Patient listed for primary debulking surgery or neo-adjuvant chemotherapy with the intent of interval debulking surgery Exclusion Criteria: * Ovarian cancer relapse * Progression of cancer * Informed consent not obtained. * Primary chemotherapy with no intent of interval surgery * Actively receiving treatment for another cancer * Secondary cancers <5years or relapsed secondary cancer in the past Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02569983

{ "NCT_ID" : "NCT01315054", "Brief_Title" : "A Methadone Maintenance Treatment Outcome Study in Three Provinces in China", "Official_title" : "A Methadone Maintenance Treatment Outcome Study in Three Provinces in China: Comparative Evaluation of the Impact of an Intensive Health Care Provider Training Program", "Conditions" : ["HIV", "Hepatitis C", "Syphilis", "Herpes Simplex Type II"], "Interventions" : ["Behavioral: MMT provider dosage training", "Other: national guidelines", "Behavioral: targeted counseling"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12", "Study_Completion_Date(Actual)" : "2018-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-03-14", "First_Posted(Estimated)" : 2011-03-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-03-14", "Last_Update_Posted(Estimated)" : 2024-08-22", "Last_Verified" : 2024-08" } }}

#Study Description Brief Summary The primary goal of this PHE is to determine the effectiveness of a tailored education program for MMT service providers. It was to be evaluated through methadone dose levels prescribed to new patients after training completion. The effects of methadone dose, with and without the inclusion of additional counseling services, would be measured through MMT retention and illicit opioid use. Detailed Description Methadone treatment has became one of main actions taken in China to control the spread of HIV among drug users. However，the average methadone dose used is relatively low. An intensive methadone maintenance treatment (MMT) provider training on methadone dosage may be effective in increasing the methadone dose levels prescribed to new patients. The study will evaluate the effectiveness of a tailored education program for MMT service providers using subsequent methadone dose prescribed to new patients. The effects of methadone dose, with and without the inclusion of additional psychosocial services, will then be measured through MMT retention and illicit opioid use. #Intervention - BEHAVIORAL : MMT provider dosage training - Training on methadone dosing provided to health care providers working in methadone maintenance clinics - Other Names : - training - BEHAVIORAL : targeted counseling - targeted counseling provided to methadone maintenance clinic attendees - Other Names : - counseling - OTHER : national guidelines - Provided a hard copy of the existing national guidelines for methadone dosing - Other Names : - dosing guidelines

#Eligibility Criteria: Inclusion Criteria: * client participants will include both men and women who are opiate-dependent drug users who started MMT not more than one month prior to enrollment in the study * 18 years or older * residing in the study areas Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01315054

{ "NCT_ID" : "NCT00137540", "Brief_Title" : "FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)", "Official_title" : "First Line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment", "Conditions" : ["Atrial Fibrillation"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2005-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-04", "Study_Completion_Date(Actual)" : "2008-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2005-08-29", "First_Posted(Estimated)" : 2005-08-30" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2005-08-29", "Last_Update_Posted(Estimated)" : 2014-11-04", "Last_Verified" : 2014-11" } }}

#Study Description Brief Summary The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation, using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic drug treatment, defined as patients with an absence of atrial tachycardias during 24 months of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead electrocardiogram (ECG) recordings. Detailed Description This study is a prospective, randomized, multicenter clinical study that will enroll in its first phase 40 patients. The study will be performed in 3 European hospitals. Patients will be randomized to either the RF ablation strategy or to the medication arm. Hypothesis: As first line therapy, catheter ablation improves the long-term success, health-economic outcomes and is equally safe compared to the best anti-arrhythmic medication treatment in a selected group of patients with paroxysmal atrial fibrillation. Primary endpoint: * long-term success, defined as patients free from any atrial fibrillation during 24 months after initial study treatment as determined by 7-days Holter and transtelephonic monitoring and by 12-lead ECG recordings. Secondary endpoints: * AF burden: frequency and duration of episodes * health-economic costs over 24 months * serious adverse events * Quality of Life scores, using SF-36 questionnaire #Intervention - DEVICE : RF ablation - DRUG : anti-arrhythmic drug therapy

#Eligibility Criteria: Inclusion Criteria: * Informed consent obtained * Two or more documented symptomatic paroxysmal atrial fibrillation episodes during the last 6 months. Episodes should last longer than 30 seconds. * Patients should not be on anti-arrhythmic medication therapy (Class I, III or IV) for AF (other than for cardioversion) or are currently on antiarrhythmic drug (AAD) therapy for any other arrhythmia Exclusion Criteria: * Patients who had a previous ablation for atrial fibrillation * Patients who had presence of severe valvular disease, myocardial infarction and/ or cardiomyopathy * Patients with a left atrial size more than 50 mm * Patients who had more than 2 cardioversions * Patients who have a history of AF for less than 3 months or more than one year * Patients with solely asymptomatic AF * Patients who have AF episodes triggered by another uniform arrhythmia * Patients who actively abuse alcohol or other drugs, which may be causative of AF * Patients with a tumor, or another abnormality which precludes catheter introduction * Patients with a revascularization or other cardiac surgery within 6 months before study treatment * Patients in whom appropriate vascular access is precluded * Patients with a contraindication to treatment with warfarin or other bleeding diathesis participants in another investigational clinical or device trial * Patients who are inaccessible for follow-up psychological problem that might limit compliance * Patients who cannot or will not fulfill the follow-up or protocol requirements * Pregnant women * Patients with severe chronic obstructive pulmonary disease * Patients with Wolff-Parkinson-White (WPW) syndrome * Patients with renal failure requiring dialysis * Patients with hepatic failure Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00137540

{ "NCT_ID" : "NCT03446924", "Brief_Title" : "Determining the Muscle Anabolic Properties of Phosphatidic Acid.", "Official_title" : "Determining the Muscle Anabolic Properties of Phosphatidic Acid in Ageing.", "Conditions" : ["Sarcopenia"], "Interventions" : ["Dietary Supplement: Rice flour", "Dietary Supplement: Phosphatidic Acid"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-03", "Study_Completion_Date(Actual)" : "2017-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-02-15", "First_Posted(Estimated)" : 2018-02-27" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-02-23", "Last_Update_Posted(Estimated)" : 2018-02-27", "Last_Verified" : 2018-02" } }}

#Study Description Brief Summary Ageing is characterized by a loss of muscle mass that is detrimental for physical function and metabolic health and increases the risk of mortality. The loss of muscle protein mass with ageing is characterized by a blunted muscle anabolic response to nutrition and exercise. Thus, interventions to counteract muscle anabolic blunting in old age might assist in the long-term maintenance of muscle mass. Phosphatidic acid (hereafter defined as 'PA') is a novel nutrient compound that has been suggested to play an important role in muscle growth. Oral consumption of PA may amplify the signalling response to nutrition and exercise and restore muscle anabolic sensitivity in older adults. In order for PA to be 'clinically' applied as a means to mitigate muscle loss in aged populations, we must first understand the efficacy and mechanisms underlying the anabolic properties of this compound, which have yet to be defined in man. The proposed pilot study is needed to investigate the acute muscle metabolic properties of oral PA supplementation in older individuals. Sixteen healthy (non-obese, non-diabetic, non-smokers) older males aged 65-75 yrs will initially complete a lower-limb strength assessment and undergo a body composition scan. Between 4-14 days after these initial assessments, participants will be assigned to co-ingest 1.5g of either phosphatidic acid (N= 8; PA) or a non-caloric placebo (N=8; PL) after following a bout of moderate intensity, single leg resistance exercise. A stable isotope infusion will be combined with serial muscle biopsies from the thigh of each leg to determine the measure rates of muscle protein synthesis in the fasted state and in the 'early' and 'late' phase of feeding-only and exercise-plus-feeding. Detailed Description The investigators will recruit 16 healthy (non-obese, non-diabetic, non-smokers) elderly men aged 65-80 yrs to complete a double-blinded, parallel designed study, in which they will be randomly assigned to a phosphatidic acid (N= 8; PA) or placebo (N=8; PL) treatment group, matched closely for anthropometric characteristics. Participants will be recreationally active, but not involved in structured exercise training. All study procedures will be clearly explained and written consent obtained prior to study participation. Preliminary assessments Following explanation of the study and the acquisition of informed consent, participants will report to our laboratory at 0800 in an overnight fasted-state and having refrained from strenuous physical activity for \>24 hrs. Participants will be weighed on a digital scale to the nearest 0.1 kg in light clothing. A dual x-ray absorptiometry (DXA) scan will be conducted to determine body composition (fat and fat-free mass). Following DXA scanning, single-leg one repetition maximum strength (1RM) will be determined for knee extension and leg press exercise machines. Selection of the limb to be exercised (dominant or non-dominant) will be randomized. Experimental trials Between 4 and 14 days after the preliminary assessments, participants will report to the laboratory at ∼0700 following an overnight fast, having refrained from strenuous physical activity for 72 hrs previously. A catheter will be inserted into a forearm vein of both arms for frequent blood sampling (∼80mL in total) and a continuous infusion of a stable isotope amino acid tracer (L- \[ring\] 13C6 phenylalanine). Participants will remain in a supine position throughout the trial with the exception of the exercise bout. After 150 min of steady-state tracer infusion a muscle biopsy will be obtained from the vastus lateralis quadriceps muscle of a randomly selected leg under local anesthesia (1% lidocaine) using the Bergström biopsy needle technique. Thereafter, participants will perform a bout of single-leg resistance exercise on the opposite leg. Exercise will consist of 6 sets of knee extension resistance exercise at 75% of the pre-determined 1RM; a protocol designed to elicit 8-12 repetitions per set prior to the onset of volitional fatigue. Immediately after exercise, participants will ingest 750mg of PA or a placebo (both in non-identifiable capsule form) with water and a further 750mg of PA or placebo at 60 mins post-exercise. Thereafter, participants will lie in a supine position for the remainder of the trial. An individual with no direct study involvement will administer treatments in a double-blind manner. Investigators will be un-blinded to treatment arms upon completion of data analysis. At 150 and 300 min following treatment consumption muscle biopsies will be obtained from both legs. Thus, a total of 5 invasive muscle biopsies will be obtained during the trial, which precludes the use of a crossover design in older individuals. Each biopsy will be obtained from a separate incision spaced ∼3cm apart. This model of study design will permit us determine rates of muscle protein synthesis in the postabsorptive state and over the early (0-2.5 h), late (2.5-5 h) and aggregate (0-5 h) time-course. Data Analyses To calculate muscle protein synthesis, the investigators will adopt sophisticated mass spectrometry techniques to determine isotopic tracer enrichment in biopsy-isolated muscle proteins and plasma. Intramuscular 'anabolic signals' (in the mechanistic target of rapamycin pathway, a key regulator of cell size) will be determined via Western Blot (a technique to detect the content of specific phospho-proteins). Plasma insulin concentrations will be measured by immunoassay and plasma lipid profiles by Gas Chromatography Mass Spectrometry. #Intervention - DIETARY_SUPPLEMENT : Phosphatidic Acid - To be administered a single dose of 1.5 g phosphatidic acid in capsule form (250 mg / capsule). - DIETARY_SUPPLEMENT : Rice flour - Rice flour placebo to be administered a single dose of 1.5 g in capsule form (250 mg / capsule).

#Eligibility Criteria: Inclusion Criteria: * Be a non-smoking male between 65 and 80 years. * Have a BMI between 18 and 25 kg/m2. * Be in good general health: no cardiovascular or metabolic diseases. Exclusion Criteria: * Health problems such as: heart disease, rheumatoid arthritis, uncontrolled hypertension, poor lung function, or any health condition that might put you at risk when participating in this study. * Generalised neuromuscular disease (such as Parkinson's disease or motorneurone disease). * Failure to obtain clearance for exercise participation from your GP or negative advice given by your GP concerning exercise participation. * Involvement in regular structured resistance exercise training at the time of the study. * Consumption of any analgesic drugs, anti-inflammatory drugs, or medication that is known to affect protein metabolism (beta-blockers, corticosteroids, NSAIDs). * Participants who have undergone muscle biopsy testing or isotope infusion procedures within the last 5 years. Sex : MALE Ages : - Minimum Age : 65 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT03446924

{ "NCT_ID" : "NCT02237183", "Brief_Title" : "Iloprost in Preventing Lung Cancer in Former Smokers", "Official_title" : "A Phase I Trial of Inhaled Iloprost for the Prevention of Lung Cancer in Former Smokers", "Conditions" : ["Lung Carcinoma"], "Interventions" : ["Other: Placebo Administration", "Drug: Iloprost", "Other: Quality-of-Life Assessment", "Other: Questionnaire Administration"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-11-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-03-05", "Study_Completion_Date(Actual)" : "2023-08-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-09-09", "First_Posted(Estimated)" : 2014-09-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-09-09", "Last_Update_Posted(Estimated)" : 2023-11-28", "Last_Verified" : 2023-11" } }}

#Study Description Brief Summary This phase I trial studies the side effects and best dose of iloprost compared with a placebo in preventing lung cancer in former smokers. Chemoprevention is the use of drugs to keep cancer from forming or coming back. Inhaled iloprost may help prevent lung cancer from forming in patients who used to smoke and who have been found to have abnormal cells in their mucus. Detailed Description PRIMARY OBJECTIVES: I. To evaluate the toxicity of inhalational iloprost administered to patients daily for 2 months, given four times a day (QID). SECONDARY OBJECTIVES: I. To evaluate the compliance QID dosing regimens. II. To evaluate the effect on endobronchial histology. III. To evaluate the effect on expectorated sputum cytology by both standard cytologic analysis and an automated three-dimensional morphologic analysis. IV. To evaluate the effect on endobronchial brushing and biopsy gene expression of peroxisome proliferator-activated receptor gamma (PPARgamma), glutathione S-transferase mu (GSTmu), carboxylesterase 1 (Ces1), Fos-related antigen 1 (FosL1), cytochrome p4502e1, stearoyl coA desaturase 1, tumor necrosis factor (TNF) superfamily member 9, transforming growth factor beta (TGFbeta), Jun and a 46 gene panel associated with dysplasia persistence, using Affymetrix arrays. V. To evaluate the improvement in chronic obstructive pulmonary disease (COPD) as measured by arterial blood gas (ABG) (improved ventilation perfusion matching), pulmonary function testing, 6-minute walk distance, quality of life (St. George's respiratory questionnaire, COPD assessment test \[CAT\]). VI. To evaluate whether the in vitro response of cultured airway epithelial progenitor cells to iloprost is a predictor of in vivo response in study subjects. OUTLINE: Patients are enrolled to Cohort A to completion prior to initiation of Cohort B. COHORT A: Patients are assigned to 1 of 2 arms. ARM I: Patients receive iloprost via inhalation using a nebulizer QID for 60 days. ARM II: Patients receive placebo via inhalation using a nebulizer QID for 60 days. COHORT B: Patients are assigned to 1 of 2 arms. COHORT B DISCONTINUED AS OF 03/26/2019. ARM III: Patients receive iloprost via inhalation using a nebulizer BID for 60 days. ARM IV: Patients receive placebo via inhalation using a nebulizer BID for 60 days. After completion of study treatment, patients are followed up at 90 days and then annually for up to 5 years. #Intervention - DRUG : Iloprost - Given via inhalation - Other Names : - Ciloprost, Iloprost Clathrate, Ventavis, ZK 36374 - OTHER : Placebo Administration - Given via inhalation - OTHER : Quality-of-Life Assessment - Ancillary studies - Other Names : - Quality of Life Assessment - OTHER : Questionnaire Administration - Ancillary studies

#Eligibility Criteria: Inclusion Criteria: * Participants must have either sputum cytologic atypia of mild dysplasia or greater or a history of bronchial biopsy with mild or greater dysplasia within the past 12 months * Participants must have a smoking history of 20 pack-years or greater * Participants must have the ability to safely undergo bronchoscopy in the judgment of the investigators * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 * Leukocytes >= 3,000/microliter * Platelets >= 100,000/microliter * Total bilirubin =< 2.0 mg/dl * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN) * Creatinine =< 2.0 mg/dl * The effects of iloprost on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because prostacyclins are known to be teratogenic, women of child-bearing potential and men having intercourse with a woman of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; Note: Women are considered to be of child-bearing potential if they are not surgically sterile or are under the age of 65 and have menstruated within the last two years * Participants must be able to understand and willing to sign a written informed consent document Exclusion Criteria: * Participants must not have used any tobacco product in the past year * Participants must not be currently receiving or have previously received thiazolidinedione treatment unless sputum atypia or endobronchial dysplasia are documented again after thiazolidinedione treatment and within 12 months of entry * Participants must not have been treated with iloprost at any time; Note: participants on the placebo arm of previous iloprost trials are eligible, but participants on the placebo arm of cohort A of this study may not be enrolled in cohort B * Participants must not have used any other investigation agent within the last six months * Participants must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition of iloprost * Participants must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that in the opinion of investigators would jeopardize patient safety of data integrity; Note: individuals who are human immunodeficiency virus (HIV) positive will not necessarily be excluded, will be considered on a case-by-case basis, but will be required to meet criteria related to patient safety and data integrity, as assessed by investigators * Participants must not have a current or prior invasive malignancy within the past 6 months; participants may enroll prior to biopsy result report, unless there are findings at bronchoscopy suggesting an invasive malignancy; history of the following curatively treated cancers during any time prior to screening is allowed: non-melanoma skin cancer, cervical carcinoma in situ, and bladder carcinoma in situ * Participants must not have received either chemotherapy or radiotherapy within the previous 6 months; Note: participants receiving long-term adjuvant hormonal therapy (such as tamoxifen or aromatase inhibitors for breast cancer) are allowed * Women must not be pregnant or breastfeeding; iloprost is a prostacyclin agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with iloprost, breastfeeding should be discontinued if the mother is treated with iloprost * As iloprost inhibits platelet function, patients must not be taking anticoagulants, with the exception of aspirin or other non-steroidal anti-inflammatory medications * Due to risk for hypotension in patients on vasodilators or antihypertensive medications, participants must not have blood pressure < 95 mm Hg systolic Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02237183

{ "NCT_ID" : "NCT04425083", "Brief_Title" : "Relationship of the Chinese Medical Constitution & Syndromes in Patients With Polycystic Ovary Syndrome", "Official_title" : "Study of the Relationship of the Chinese Medical Constitution & Syndromes and Quality of Life in Patients With Polycystic Ovary Syndrome", "Conditions" : ["Polycystic Ovary Syndrome"], "Interventions" : ["Other: no intervention"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-11-18", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-12-31", "Study_Completion_Date(Actual)" : "2017-12-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-05-23", "First_Posted(Estimated)" : 2020-06-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-06-06", "Last_Update_Posted(Estimated)" : 2020-06-11", "Last_Verified" : 2020-06" } }}

#Study Description Brief Summary This study is a cross-sectional study. The purpose is to understand the characteristics of Chinese medicine constitutional syndrome in patients with polycystic ovary. In addition, the health-related quality of life (SF-36), mental state (stress, depression) of patients with polycystic ovary , Anxiety) and the relationship between hormone biochemical indicators and TCM constitutional syndromes, to develop a pioneering study on TCM constitution diagnosis and life guidelines for polycystic ovarian patients and future clinical adjuvant therapy. Detailed Description The study conducted in the Obstetrics and Gynecology Department of the Neihu District of the Taipei Three Military General Hospital. It is expected that 200 cases of polycystic ovary will be diagnosed by specialists; 'Quality of Life Questionnaire (SF-36)' evaluates the quality of life of patients; 'BAI and BDI-II' evaluates patients 'anxiety and depression; 'Stress Perception Scale' evaluates patients' life stress And testing the blood indexes of patients such as FSH, LH, E2, testosterone, TSH, prolactine. Observe the correlation between the quality of life, psychological state, and blood test values of polycystic ovarian patients with physical characteristics of traditional Chinese medicine. #Intervention - OTHER : no intervention - no intervention

#Eligibility Criteria: Inclusion Criteria: A polycystic ovarian patient was diagnosed by a specialist in obstetrics and gynecology according to the diagnostic criteria set by the Rotterdam ESHRE / ASRM-sponsored PCOS workshop group (2004) in 2003. Exclusion Criteria: * Exclude diseases similar to the clinical manifestations of polycystic ovary, such as cushing syndrome, congenital adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia. * Diagnose a clear mental disorder (such as schizophrenia, severe depression) or take psychiatric drugs (anti-depression or anxiety drugs). * Pregnancy, oral contraceptives, use high-dose exogenous androgens, breastfeeding. * Those with a history of stroke, myocardial infarction, major trauma or surgery within the past six months. * Have taken Chinese medicine in the past month. Sex : FEMALE Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT04425083

{ "NCT_ID" : "NCT01791595", "Brief_Title" : "A Phase I Trial of AZD3965 in Patients With Advanced Cancer", "Official_title" : "A Cancer Research UK Phase I Trial of AZD3965, a Monocarboxylate Transporter 1 Inhibitor (MCT1) in Patients With Advanced Cancer", "Conditions" : ["Adult Solid Tumor", "Diffuse Large B Cell Lymphoma", "Burkitt Lymphoma"], "Interventions" : ["Drug: AZD3965"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-04-23", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-11-17", "Study_Completion_Date(Actual)" : "2020-11-17}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-02-11", "First_Submitted_that_Met_QC_Criteria" : 2022-02-10", "First_Posted(Estimated)" : 2013-02-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-02-13", "Last_Update_Posted(Estimated)" : 2022-04-11", "Last_Verified" : 2022-02" } }}

#Study Description Brief Summary The main aims of this clinical study are to find out the maximum dose that can be given safely to patients, the potential side effects of the drug and how they can be managed and what happens to AZD3965 inside the body. AZD3965 is a type of drug called a monocarboxylate transporter 1 inhibitor which is being used to stop the growth of cancer cells and kill cancer cells by blocking the action of one of the proteins involved in moving chemical compounds in and out of the cells of the body. This will be the first time that this type of drug has been given to patients. The drug is a capsule and is taken daily. The study is in two parts. In Part 1 of the study, small groups of patients are treated at increasing doses to find the highest safe dose and best dose to give to patients in Part 2 of the study. It is planned that 40 patients will be entered into Part 1 of the trial. In Part 2, the dose found to be safe in Part 1 is given to patients with diffuse large B-cell lymphoma (DLBCL) and Burkitt's lymphoma (BL). It is planned that 20 patients will be entered into Part 2 of the trial. Patients will need to visit the hospital weekly for two months and then every fortnight. Patients will have regular blood and urine tests, scans, heart traces and eye tests amongst other clinical tests. Research blood samples will also be taken to look at what happens to the drug inside the body. Treatment is planned to be given for up to 6 months, but patients benefiting from treatment will be able to keep having it for as long as they continue to benefit. It is important to explain that this is the first study of this drug and patients will have advanced cancer so it is unlikely that patients will benefit directly from taking part but the study may help improve future treatment of cancer. Detailed Description Part 1 follows a rolling six dose escalation schedule of AZD3965 given once daily (OD) or twice daily (BD) until the maximum tolerated dose (MTD) is defined. The recommended Phase II dose (RP2D) is based on the safety and pharmacokinetic (PK) results from Part 1. All patients in Part 2 are treated at this RP2D to further explore the tolerability of this dose and schedule and to explore proof of principle of MCT1 inhibition in tumour types that were shown to express MCT1 and in which AZD3965 showed some effect pre-clinically (DLBCL and BL). #Intervention - DRUG : AZD3965 - Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. - DRUG : AZD3965 - Day -7: single dose of 10 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. - DRUG : AZD3965 - Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 20 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. - DRUG : AZD3965 - Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 30 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. - DRUG : AZD3965 - Day -7: single dose of 30 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 15 mg AZD3965 BD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. - DRUG : AZD3965 - Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. - DRUG : AZD3965 - Day -7: single dose of 20 mg AZD3965 orally prior to start of continuous treatment (first 3 trial participants in the Expansion Cohort only; subsequent patients started treatment at Cycle 1, Day 1). Cycle 1, Day 1: commenced dosing of 10 mg AZD3965 BD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor.

#Eligibility Criteria: Inclusion Criteria: * Part 1: * Histologically or cytologically proven advanced solid tumour or lymphoma, refractory to conventional treatment or for which no conventional therapy exists. * Available archived tumour samples. Part 2: * Histologically proven DLBCL or BL, which is relapsed or refractory to conventional treatment or for which no conventional therapy exists or has been refused by the patient. * Confirmed available tumour samples which can be obtained and used for the study to confirm MCT1 and MCT4 expression as demonstrated by immunohistochemistry. * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or International Working Group (IWG) criteria for Lymphoma. * Life expectancy of at least 12 weeks. * World Health Organization (WHO) performance status of 0 or 1. * Haematological and biochemical indices within the ranges shown below. Laboratory Test Value required: * Haemoglobin (Hb) >=9.0 g/dL (90 g/L) or >=10.0 g/dL (100 g/L) if transfusion within last 4 weeks. * Absolute neutrophil count (ANC) Part 1: >=1.5 x 10^9/L; Part 2: >=1.0 x 10^9/L. * Platelet count Part 1: >=100 x 10^9/L; Part 2: >=50 x 10^9/L. * Serum bilirubin <=1.5 x upper limit of normal (ULN). * Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) <=2.5 x ULN or <=5 x ULN in presence of liver metastases (ALP <=5 x ULN in presence of bone metastases). * Glomerular filtration rate (GFR) either: Calculated creatinine clearance or: Isotope clearance measurement (uncorrected) >=50 mL/min. * Prothrombin time <1.5 x ULN. * Glucose (fasting) <7.8 mmol/L; * Lactate between 0.5 and 2.5 mmol/L inclusive and bicarbonate between 22 mmol/L and 1.5 x ULN inclusive. * Left ventricular ejection fraction (LVEF) >50%. * 18 years or over. * Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up. Exclusion Criteria: * Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C and 4 weeks for investigational medicinal products) before treatment. * Ongoing toxic manifestations of previous treatments greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the Investigator and the Cancer Research UK Centre for Drug Development should not exclude the patient. * Symptomatic brain or leptomeningeal metastases. * Patients with known retinal disease or macular degeneration affecting visual acuity as assessed by ophthalmologic tests. * Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one highly effective form plus a barrier method) [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom] or agree to sexual abstinence, effective from the first administration of AZD3965, throughout the trial and for six months afterwards are considered eligible. * Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence effective from the first administration of AZD3965, throughout the trial and for six months afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate. * Any major surgery in the preceding eight weeks prior to the start of treatment or major thoracic or abdominal surgery from which the patient has not yet recovered. * Patients who are unable to swallow oral medication. * Alterations to corticosteroid dose within 2 weeks prior to first dose of AZD3965. * Gastrointestinal disorders likely to interfere with absorption of the study drug (e.g. partial bowel obstruction or malabsorption). * At high medical risk because of non-malignant systemic disease including active uncontrolled infection. * Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV). (N.B. Mandatory testing not required). * History of serious allergy or auto-immune disease. * Diabetes mellitus (patients with diet controlled diabetes may be included with fasting glucose <7.8 mmol/l and normal haemoglobin A1c [HbA1c]). * Cardiac conditions as follows: * Clinically significant cardiovascular event within 6 months prior to study entry to include: 1. acute coronary syndrome (myocardial infarction or unstable angina), 2. congestive heart failure requiring therapy. * Severe valvular heart disease (as defined by British Society of Echocardiography). * Presence of an atrial or ventricular arrhythmia, other than atrial fibrillation with well controlled ventricular rate, for which treatment is indicated (anti-arrhythmic drugs or implantable cardioverter defibrillator). * Second degree Mobitz type 1 (Wenckebach) heart block with symptoms, or second degree Mobitz type 2 or third degree heart block with or without symptoms unless functioning pacing system. * QTc >450 msec in adult male and >460 msec in adult females (QTc to be verified manually [Fridericia's Correction]). * History of congenital long QT syndrome. * History of Torsade de Pointes (or any concurrent medication with a known risk of inducing QT prolongation). * Uncontrolled hypertension (blood pressure >=160/100 mmHg despite medical therapy). * Extensive radiotherapy to greater than 25% of bone marrow within 8 weeks. Prior autologous bone transplant will not exclude a patient. * Is a participant, or plans to participate in another interventional clinical trial, whilst taking part in this Phase I study of AZD3965. Participation in an observational or interventional clinical trial that does not involve administration of an IMP would be acceptable. * Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial. * For Part 2 only: Current malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; and patients with low risk prostate cancer on surveillance (with a Gleason score of <=6 and a Prostate Specific Antigen of <=10). Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01791595

{ "NCT_ID" : "NCT00064350", "Brief_Title" : "Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer", "Official_title" : "A Double Blind Phase II Study of BAY 43-9006 in Patients With Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens", "Conditions" : ["Lung Cancer"], "Interventions" : ["Drug: Placebo", "Drug: Sorafenib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2004-06-28", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-03", "Study_Completion_Date(Actual)" : "2011-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2003-07-08", "First_Submitted_that_Met_QC_Criteria" : 2012-11-26", "First_Posted(Estimated)" : 2003-07-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2003-07-08", "Last_Update_Posted(Estimated)" : 2023-06-29", "Last_Verified" : 2023-06" } }}

#Study Description Brief Summary RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer. Detailed Description OBJECTIVES: * To determine the percent of patients maintaining stable disease or objective response two months after randomization with continued sorafenib treatment, compared to patients switched to placebo. * To determine progression-free survival, overall survival, and response rate. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to number of prior chemotherapy regimens (2 vs more than 2) and prior epidermal growth factor receptor inhibitor treatment (yes vs no). * Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression. * Randomization: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who develop disease progression within 1 year after randomization cross over to arm I. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 311 patients will be accrued for this study within approximately 3 years. #Intervention - DRUG : Sorafenib - Step 1 (induction): Sorafenib was giventwice daily for two cycles to all patients. Patients with progression (PD) discontinued treatment. Those who responded after two cycles continued treatment up to 1 year or until PD. With response after 1 year, patients were given the option to continue treatment until PD. Patients who were stable after the end of induction were then randomized onto Step 2 to either continue sorafenib or receive placebo. Step 2 (randomization): Patients with stable disease after induction will be randomized in a double-blinded manner to placebo or sorafenib. If a patient has progressed, the arm will be unblinded. Patients on placebo with PD can then crossover to receive sorafenib; patients with PD on the sorafenib arm will be removed from the study. Step 3 (crossover): If patients on placebo progressed within 1 year from randomization, they crossed over to the treatment arm and receive sorafenib for up to 1 year or until PD, unacceptable toxicity, or death. - Other Names : - Nexavar, BAY 43-9006 - DRUG : Placebo - Patients randomized to the placebo arm in step 2 continued receiving placebo until disease progression or one year from randomization. Placebo was given orally twice a day (BID).

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) * Disease must have progressed after at least 2 prior chemotherapy regimens for NSCLC * Patients must have measurable or nonmeasurable disease * Absolute neutrophil count at least 1,500/mm^3 * Platelet count at least 100,000/mm^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 3 times ULN (5 times ULN in patients with liver disease) * Creatinine less than 1.5 times ULN or calculated creatinine clearance greater than 50 mL/min * More than 3 weeks since prior chemotherapy, radiotherapy, immunotherapy or other investigational drug use * Recovered from all prior therapy * Fertile patients must use effective contraception * Age >= 18 * ECOG performance status of 0 <= age <= 1 Exclusion Criteria: * Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable and off therapy for at least 2 months * Active second malignancy * Clinically evident congestive heart failure, serious cardiac arrhythmias, or symptoms of coronary heart disease * Prior radiotherapy to the only site of measurable or evaluable disease unless there is evidence of disease progression in that site * Prior exposure to a ras pathway inhibitor (e.g., farnesyl transferase inhibitor) * Concurrent medications known to be metabolized by the liver with a narrow therapeutic index, including the following: * Ketoconazole * Itraconazole * Quinidine * Digoxin * Cyclosporine * Ritonavir * Grapefruit products * Carbamazepine * Phenytoin * Phenobarbital * Pregnant or nursing * Clinically serious active infection * Medical conditions, substance abuse or psychological/social situation that would preclude study participation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00064350

{ "NCT_ID" : "NCT00778934", "Brief_Title" : "In-Home Use Study to Evaluate Use of an Intimate Health Product in Females", "Official_title" : "A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females", "Conditions" : ["Coitus"], "Interventions" : ["Other: Intimate Health Gel"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-02", "Study_Completion_Date(Actual)" : "2008-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-10-23", "First_Posted(Estimated)" : 2008-10-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-10-23", "Last_Update_Posted(Estimated)" : 2011-10-06", "Last_Verified" : 2011-10" } }}

#Study Description Brief Summary The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females. Detailed Description Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire. #Intervention - OTHER : Intimate Health Gel - Intimate Health Gel - Other Names : - Not marketed yet

#Eligibility Criteria: Inclusion Criteria: * Normal, healthy females >18 years * In committed heterosexual relationship for >6months * Of adequate sexual functioning * On acceptable method of birth control Exclusion Criteria: * Pregnant or breastfeeding * Allergy to product ingredients * Irritation or infection in genital area * Unstable or uncontrolled medical condition Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT00778934

{ "NCT_ID" : "NCT03801772", "Brief_Title" : "Effects of a Metronome on Functional Outcomes in Aquatic Therapy", "Official_title" : "Effects of a Metronome on Functional Outcomes in Aquatic Therapy", "Conditions" : ["Exercise Therapy"], "Interventions" : ["Device: Metronome"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-01-21", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-31", "Study_Completion_Date(Actual)" : "2021-04-16}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-01-08", "First_Posted(Estimated)" : 2019-01-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-01-09", "Last_Update_Posted(Estimated)" : 2021-09-02", "Last_Verified" : 2021-09" } }}

#Study Description Brief Summary The purpose of this study is to determine if the use of a pacing device, a metronome, improves functional outcome measures in aquatic therapy when compared to a control group. #Intervention - DEVICE : Metronome - Pacing aquatic exercises to the beats per minute of a metronome. The metronome will be adjusted to each patient's pain free exertion level. Patients will start with 10-20 repetitions of the exercises depending on their physical ability. The repetitions will be progressed as the patient's strength and endurance improve and noted in the chart and the flow sheet. The metronome will be synchronized during their second aquatic therapy treatment. The beats per minute (BPM) will be increased on the metronome during the series of treatments until the patient can no longer maintain proper technique with the exercises. The exercises will continue at this BPM during future visits. The patient will be instructed to keep pace with the beat of the metronome for the duration of the exercise.

#Eligibility Criteria: Inclusion Criteria: * All patients over the age of 18 assigned to aquatic therapy Exclusion Criteria: * Women who identify themselves as pregnant on the clinics intake sheet. * Anyone unable to hear the beats of the metronome. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03801772

{ "NCT_ID" : "NCT00002185", "Brief_Title" : "A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients With CD4 <= 500 Cells/mm3", "Official_title" : "A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients With CD4 <= 500 Cells/mm3", "Conditions" : ["Sarcoma, Kaposi", "HIV Infections"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Interventional_Model" : "PARALLEL", }, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 1999-11-02", "First_Posted(Estimated)" : 2001-08-31" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2001-08-30", "Last_Update_Posted(Estimated)" : 2005-06-24", "Last_Verified" : 1999-05" } }}

#Study Description Brief Summary To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS). Detailed Description This is an open-label, randomized, pilot, Phase II study of the safety and efficacy of Viracept in combination with modified antiretroviral therapy as treatment in patients with cutaneous and mucosal KS. Patients will be randomized to modify (add or switch or initiate) their current antiretroviral therapy and will add Viracept or remain on their current background antiretroviral therapy for a 2 month period. Initially 20 patients will be randomized in a 2:1 ratio (i.e., 14 Viracept, 6 control) for a 2 month period. Response to therapy will be evaluated at the end of the 2 month control phase. At this point, patients who were initially assigned to the control arm will continue on open label Viracept for an additional 10 month period. #Intervention - DRUG : Nelfinavir mesylate

#Eligibility Criteria: Inclusion Criteria Patients must have: * HIV-positivity. * Diagnosed KS proven by biopsy. * NOTE: * Patients must not opt for immediate topical, systemic or radiation treatment. * At least 4 cutaneous lesions not treated within the previous 4 weeks. * Life expectancy > 6 months. * Signed, informed consent from parent or legal guardian for those patients < 18 years. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: * Neoplastic disease (excluding KS) requiring systemic cytotoxic or radiation therapy or who have had these therapies within 1 month of baseline and have not completely recovered from the effects of these therapies. * Unstable or severe intercurrent medical conditions, including but not limited to, significant symptomatic visceral KS. * Clinically significant malabsorption syndrome. * Renal insufficiency. Patients with any of the following prior conditions are excluded: Significant Fever (> 101 degrees F (38 degrees C) for >= 7 days) and/or diarrhea (> 6 loose stools/day for >= 7 days) within one month of baseline. * Immediate topical or systemic treatment for KS lesions. * Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day concurrently. Immediate radiation treatment. * Treatment of KS lesions with intra-lesional chemotherapy within 4 weeks of entry. * History of > 2 weeks of prior therapy with Indinavir or Ritonavir. * Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day within 4 weeks of entry. Treatment of KS lesions with radiation within 4 weeks of entry. Active substance abusers; urine drug tests may be performed if drug abuse is suspected. Sex : ALL Ages : - Minimum Age : 13 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT00002185

{ "NCT_ID" : "NCT05460338", "Brief_Title" : "Vitamin D, Oxidative Stress and Inflammation in Hemodialysis", "Official_title" : "Effect of Oral Vitamin D on Oxidative Stress and Inflammation in Hemodialysis", "Conditions" : ["Oxidative Stress", "Inflammation", "Vitamin D Deficiency"], "Interventions" : ["Drug: Cholecalciferol"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-05-15", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-09-15", "Study_Completion_Date(Actual)" : "2023-01-26}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-07-13", "First_Posted(Estimated)" : 2022-07-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-07-13", "Last_Update_Posted(Estimated)" : 2023-02-06", "Last_Verified" : 2023-02" } }}

#Study Description Brief Summary Vitamin D deficiency is now considered a global problem in general population, but it seemed to be more prominent in chronic kidney disease (CKD) patients, especially those on regular hemodialysis. Being a key regulator in mineral metabolism, there's also emerging evidences linking vitamin D deficiency with inflammation and oxidative stress, which are both recognized as constant threats to cardiovascular outcomes in hemodialysis patients. It's prospective, randomized trial that's carried out to evaluate the effect of weekly versus, monthly oral cholecalciferol, on vitamin D (25(OH)D) levels, oxidative stress markers, inflammatory markers and secondary hyperparathyroidism in hemodialysis patients. Fifty eligible hemodialysis patients were randomly assigned to either Group A (Oral 50.000IU Cholecalciferol, once weekly) or Group B (Oral 200.000IU Cholecalciferol, once monthly), for 3 months. Serum levels of (25(OH)D), serum malondialdehyde (MDA), serum superoxide dismutase (SOD), serum high sensitive (hsCRP), calcium, phosphorus, and intact parathormone (iPTH) levels, were all assessed at baseline and at the end of the study #Intervention - DRUG : Cholecalciferol - native form of Vitamin D.

#Eligibility Criteria: Inclusion Criteria: * Male or female patients aged between 18 <= age <= 70 years, on maintenance hemodialysis for a duration of 3 months or more, in a stable clinical condition (no hospitalization in the previous 3 months), with serum vitamin D levels of < 30 ng/ml. Exclusion Criteria: * Patients with hypersensitivity to cholecalciferol, ongoing cholecalciferol therapy, liver failure, digestive malabsorption disease, being participating in an another clinical trial within the past 4 weeks, females that are pregnant or breastfeeding, or patients being judged to be unsuitable to be enrolled by the attending physician. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05460338

{ "NCT_ID" : "NCT00685906", "Brief_Title" : "AZD6140 Oral Contraceptive Interaction Study", "Official_title" : "A Randomised, Double-blind, Two-way Crossover Study to Determine the Effects of Co-administration of AZD6140 and Nordette® (Combination of Levonorgestrel and Ethinyl Estradiol) After Multiple Oral Doses in Healthy Female Volunteers", "Conditions" : ["Healthy"], "Interventions" : ["Drug: AZD6140", "Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2008-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-10", "Study_Completion_Date(Actual)" : "2008-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-05-27", "First_Posted(Estimated)" : 2008-05-29" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-05-28", "Last_Update_Posted(Estimated)" : 2010-12-02", "Last_Verified" : 2010-12" } }}

#Study Description Brief Summary The purpose of this study is to examine the effect of co-administration of AZD6140 and Nordette® on the blood levels of certain female hormones. #Intervention - DRUG : AZD6140 - 90 mg tablet taken by mouth 2 times a day for 21 days per cycle - DRUG : Levonorgestrel and Ethinyl Estradiol (Nordette®) - 1 tablet taken by mouth once a day for 28 days per cycle - Other Names : - Nordette®

#Eligibility Criteria: Inclusion Criteria: * Females who are healthy, non-pregnant, not planning pregnancy within the study period, non-breast-feeding, and pre-menopausal * Either currently taking Nordette® which was well tolerated for at least two months prior to randomisation with no history of break-through bleeding, or, willing to take Nordette for 2 months prior to receiving the study drug * Females of child-bearing potential must be willing to use at least 1 additional medically approved non-hormonal barrier contraceptive method (for example, condom or diaphragm) that contains spermicide Exclusion Criteria: * History of intolerance (e.g. adverse events) to any oral contraceptive or AZD6140 * History of blood vessel or bleeding conditions that would make the volunteer more prone to bleeding * History or presence of significant medical problems * Women who are current smokers Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT00685906

{ "NCT_ID" : "NCT01026181", "Brief_Title" : "Gastric Procedures for Obesity", "Official_title" : "Phase II Study of Comparing Outcomes of Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Gastric Banding to Treat Morbid Obesity", "Conditions" : ["Morbid Obesity"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2008-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-07", "Study_Completion_Date(Actual)" : "2011-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-12-03", "First_Submitted_that_Met_QC_Criteria" : 2017-05-03", "First_Posted(Estimated)" : 2009-12-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-12-03", "Last_Update_Posted(Estimated)" : 2017-10-03", "Last_Verified" : 2017-05" } }}

#Study Description Brief Summary This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.

#Eligibility Criteria: Inclusion Criteria: * morbid obese patients aged from 18 <= age <= 65, * BMI > 40 kg/m2 or BMI> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc. Exclusion Criteria: * psychiatric illness, * substance abuse, * previous gastrointestinal surgery, and * any patient who transfers from laparoscopic to convention procedure. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01026181

{ "NCT_ID" : "NCT03023956", "Brief_Title" : "Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures", "Conditions" : ["Humeral Fracture, Proximal", "Internal Fixation; Complications, Mechanical, Bones of Limb"], "Interventions" : ["Procedure: Locking plates were used for proximal humeral fractures."], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-12", "Study_Completion_Date(Actual)" : "2017-01-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-01-12", "First_Posted(Estimated)" : 2017-01-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-01-13", "Last_Update_Posted(Estimated)" : 2017-01-24", "Last_Verified" : 2017-01" } }}

#Study Description Brief Summary From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck fractures (SNF), we divided the patients into two groups. All the patients were followed at least 1 year. #Intervention - PROCEDURE : Locking plates were used for proximal humeral fractures.

#Eligibility Criteria: Inclusion Criteria: *From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate. Exclusion Criteria: * Patients had pathologic fractures, * Patients had previous surgery on the affected shoulder, * Patients were treated with shoulder arthroplasty. * Patients were treated with intramedullary nail. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03023956

{ "NCT_ID" : "NCT05572567", "Brief_Title" : "Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis", "Official_title" : "An Observational Study Within the CorEvitas Registry to Evaluate Safety and Effectiveness of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs (bDMARDs) in Japan Among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis", "Conditions" : ["Arthritis, Rheumatoid"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-10-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-10", "Study_Completion_Date(Actual)" : "2022-10-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-10-05", "First_Posted(Estimated)" : 2022-10-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-10-05", "Last_Update_Posted(Estimated)" : 2023-06-28", "Last_Verified" : 2023-06" } }}

#Study Description Brief Summary This is a secondary structured database observational study conducted in Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the CorEvitas Japan RA Registry. The data as of September 2022 will be used for this study. The study will include data from March 2016 to the latest data cut available in 2022 for both effectiveness and safety outcomes.

#Eligibility Criteria: Inclusion Criteria: * Diagnosed with Rheumatoid Arthritis (RA) according to the 1987 American College of Rheumatology (ACR) or the ACR/European Lead Against Rheumatism (EULAR) 2010 RA Classification Criteria; * At least 18 years or older; * Was / Must be prescribed or switching to the following eligible medication for the first time ever at the enrollment visit: * csDMARD: methotrexate (closed in February 2018); * Anti-TNF bDMARD: adalimumab (originator or biosimilar), certolizumab pegol, etanercept (originator or biosimilar), golimumab, infliximab (originator or biosimilar), or any other anti-TNF biosimilar approved during the study; * Non-TNF bDMARD: abatacept, tocilizumab, sarilumab (closed in June 2020); * JAK inhibitor: tofacitinib, baricitinib, peficitinib, filgotinib, upadacitinib. Exclusion Criteria: * Data that are prior to March 2016 and after June 2022 Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05572567

{ "NCT_ID" : "NCT03826316", "Brief_Title" : "Pharmacokinetics of Nalbuphine Injection", "Official_title" : "A Study to Evaluate Pharmacokinetics of Nalbuphine Hydrochloride (10 mg/mL) After a Single Intravenous Administration in Healthy Volunteers Under Fasting Conditions", "Conditions" : ["Pain, Postoperative"], "Interventions" : ["Drug: Nalbuphine"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-01-15", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-11-22", "Study_Completion_Date(Actual)" : "2019-01-15}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-01-27", "First_Posted(Estimated)" : 2019-02-01" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-01-30", "Last_Update_Posted(Estimated)" : 2019-02-01", "Last_Verified" : 2019-01" } }}

#Study Description Brief Summary A study to evaluate pharmacokinetics of nalbuphine hydrochloride (10 mg/mL) after a single intravenous administration in healthy volunteers under fasting conditions #Intervention - DRUG : Nalbuphine - Pharmacokinetic study under fasting conditions

#Eligibility Criteria: Inclusion Criteria: * Healthy adult male subjects between 20 <= age <= 45 years. * Body weight within 80 <= age <= 120% of ideal body weight. * Ideal body weight (kg) = [height (cm) - 80] *0.7 for male subjects * Acceptable medical history and physical examination including: * no particular clinically significant abnormalities in chest x-ray and electrocardiogram results within six months prior to study drug dosing. * no particular clinical significance in general disease history within two months prior to study drug dosing. * Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes Serum Glutamic Oxaloacetic Transaminase (SGOT, same as AST), Serum Glutamic Pyruvic Transaminase (SGPT, same as ALT), Gamma-Glutamyl-Transpeptidase (γ-GT), alkaline phosphatase, total bilirubin, albumin, glucose, Blood Urea Nitrogen(BUN), uric acid, creatinine, total cholesterol and triglyceride (TG). * Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets. * Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes power of hydrogen (pH), blood, glucose, ketones, bilirubin and protein. * Male subjects willing to use a condom during any sexual contact with females of reproductive potential for up to 10 weeks after study drug dosing. * Have signed the written informed consent to participate in the study. Exclusion Criteria: * A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the investigator). * A clinically significant illness or surgery within four weeks prior to dosing (as determined by the investigator). * History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years. * History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant. * Known or suspected history of drug abuse within lifetime as judged by the investigator. * History of alcohol addiction or abuse within last five years as judged by the investigator. * History of allergic response(s) to nalbuphine hydrochloride or any other related drugs. * Evidence of chronic or acute infectious disease. * Positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV). * Female subjects demonstrating a positive pregnancy screen prior to the study. * Female subjects who are currently breastfeeding. * Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine. * Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to dosing. * Use of any investigational drug within four weeks prior to dosing. * Donating more than 250 milliliter (mL) of blood within two months prior to dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to dosing. * Any other medical reason as determined by the investigator. Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT03826316

{ "NCT_ID" : "NCT04282967", "Brief_Title" : "Streaming Web-based Exercise At Home: A Pilot Study", "Official_title" : "IIT2019-14-SHIRAZIP-SWEAT: Streaming Web-based Exercise At Home: A Pilot Study", "Conditions" : ["Prostate Cancer", "Breast Cancer Female"], "Interventions" : ["Behavioral: Exercise"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-07-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-30", "Study_Completion_Date(Actual)" : "2023-03-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-02-20", "First_Posted(Estimated)" : 2020-02-25" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-02-21", "Last_Update_Posted(Estimated)" : 2023-04-11", "Last_Verified" : 2023-04" } }}

#Study Description Brief Summary This is a single-arm pilot study to evaluate the use of web-based video conferencing as a method of exercise training delivery. This study will include 10 female breast cancer survivors and 10 male prostate cancer survivors. For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise. #Intervention - BEHAVIORAL : Exercise - For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.

#Eligibility Criteria: Inclusion Criteria: * Male previously diagnosed with prostate cancer or female previously diagnosed with breast cancer. * For breast cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable. * For prostate cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for androgen receptor-targeted therapies (such as enzalutamide, apalutamide, darolutamide, or abiraterone). Patients currently on active surveillance are eligible even if they have not received prior anti-cancer treatment. * Has access to tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across. * Physically able to complete modified Bruce submaximal treadmill test, leg strength test, grip strength test, and InBody per patient self-assessment. * Physician clearance to participate in this study. Can be done through review of patients' medical records. * Ability to read, write, and understand English. * Has a chair at home to use for exercise that is not on wheels and has a solid back (not a reclining chair). * Ambulatory without assistance. * Has a clear 5 x 6-foot space at home in which to exercise. * Age >18 years. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Active treatment planned within the next 6 months. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for AR-targeted therapies for prostate cancer. * Known metastatic disease. * Grade 3 or higher peripheral neuropathy. * Major surgery within 3 months of baseline visit. * Positive pregnancy test for women of child-bearing potential. * Answers yes to any question on the Physical Activity Readiness Questionnaire unless study participation is cleared by a physician. * Known allergy to Fitbit device. * Currently meeting physical activity guidelines (score of >23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire). Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04282967

{ "NCT_ID" : "NCT02832622", "Brief_Title" : "MultiPoint Pacing™ Post Market Study", "Official_title" : "MultiPoint Pacing™ Post Market Study", "Conditions" : ["Heart Failure"], "Interventions" : ["Device: BiV/MPP", "Device: MPP"], "Location_Countries" : ["Japan", "Argentina", "Colombia", "United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-15", "Study_Completion_Date(Actual)" : "2019-07-15}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-07-05", "First_Submitted_that_Met_QC_Criteria" : 2021-02-09", "First_Posted(Estimated)" : 2016-07-14" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-07-11", "Last_Update_Posted(Estimated)" : 2021-02-17", "Last_Verified" : 2021-02" } }}

#Study Description Brief Summary This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation. Detailed Description Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will be specified in the protocol. Patients will be followed for 12 months after implant. Data will be collected at Baseline (within 30 days prior to implant), Post-Implant (within 30 days following successful CRT device implant), 3, 6, 12 months and during any unscheduled follow-up visit. #Intervention - DEVICE : MPP - MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously) - DEVICE : BiV/MPP - MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)

#Eligibility Criteria: Inclusion Criteria: * Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular lead placement * Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: * Are expected to receive a heart transplant during the duration of the study * Have an epicardial ventricular lead system (Active or Inactive) * Are less than 18 years * Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm * Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02832622

{ "NCT_ID" : "NCT03104543", "Brief_Title" : "Communicating Health Information and Improving Coordination With Primary Care", "Official_title" : "Communicating Health Information and Improving Coordination With Primary Care - an Ancillary Study of the Childhood Cancer Survivor Study", "Conditions" : ["Hypertension", "Dyslipidemias", "Diabetes", "Childhood Cancer"], "Interventions" : ["Behavioral: Education", "Behavioral: Test results only"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-03-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-01", "Study_Completion_Date(Actual)" : "2022-12-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-03-23", "First_Submitted_that_Met_QC_Criteria" : 2024-01-13", "First_Posted(Estimated)" : 2017-04-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-04-03", "Last_Update_Posted(Estimated)" : 2024-03-06", "Last_Verified" : 2024-02" } }}

#Study Description Brief Summary Survivors of childhood cancer are known to be at higher risk of developing premature, serious cardiovascular disease compared with the general population. Hypertension, dyslipidemia, and diabetes increase this risk beyond that attributable to one's original cancer therapy exposures. Research has shown that childhood cancer survivors also have a high burden of underdiagnosis and undertreatment of these potentially modifiable conditions. The goal of this study is to: 1. To determine the prevalence of underdiagnosis and undertreatment of common cardiometabolic conditions (i.e., hypertension, dyslipidemia, diabetes) in survivors of childhood cancer at high-risk of future serious cardiovascular disease. 2. Among survivors who are found to be underdiagnosed or undertreated, to determine (via randomized clinical trial) the efficacy of an educational intervention to improve control of these cardiometabolic conditions. 3. Determine barriers on among survivors enrolled on the randomized trial and their primary healthcare providers that contribute to undertreatment of the study's targeted cardiometabolic conditions. Detailed Description What is the CHIIP Study? The CHIIP Study is for Long-Term Follow-Up (LTFU) Study participants who are more likely to experience heart problems because of their cancer treatment. We want to figure out how common high blood pressure, high blood cholesterol, and high blood sugar are among LTFU Study participants. What will be asked of participants? LTFU Study participants who choose to enroll in this study will be asked to: * Answer one or two short questionnaires about their medical history, current health, mood, lifestyle, and healthcare access. * Schedule a one-time visit for an examiner to come to their home (or another location chosen by the participant) to measure blood pressure, height, weight, waist circumference, and to draw blood to test their cholesterol and blood sugar. * If all the test results are normal, the participant will be done with the study. If the participant has a higher than normal test result, they will remain in the study and be randomly assigned to one of two groups to learn how to improve health. A year later, participants in both groups will be asked to repeat the tests mentioned above. What's in it for participants? Participants will have some basic health measurements done for free, including height, weight, blood pressure, and blood levels of cholesterol and sugar. The participant and their primary care provider will receive a copy of all these test results free of cost. We hope the information we gather will provide future benefits for people who were treated for cancer as children. #Intervention - BEHAVIORAL : Education - 30 minute education session; 15 minute booster session at 4 months - BEHAVIORAL : Test results only - The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year

#Eligibility Criteria: Inclusion Criteria: * CCSS participant who is age >=18 years at time of consent * High cardiovascular risk status based on CCSS risk prediction models for cardiomyopathy and ischemic heart disease * Able to read, write, and speak English * Living in the U.S., within 50 miles of a designated EMSI center based on CCSS's available contact information at the time of approach. * At least one abnormal CV condition identified on home visit: blood pressure >=130/80 mmHg or >=130/80 if pre-existing hypertension; LDL >=160 mg/dL; triglyceride >=150 mg/dL (if >=10 hours fast) or >=200 mg/dL (if <10 hours fast); or glucose >=100 mg/dL if >=8 hours fast) or >=140 mg/dL (if <8 hours fast) or HbA1c >=5.7% (if not known to be diabetic), HbA1c >=7% (if known diabetic) * Free of known self-reported ischemic heart disease or cardiomyopathy * Have access to a telephone, computer, or smartphone to receive a phone or web video-based educational intervention Exclusion Criteria: * Individuals with known cardiomyopathy or ischemic heart disease based on prior CCSS surveys are excluded. While not likely to be common, participants who newly report in our study's baseline survey that they have cardiomyopathy or ischemic heart disease can have a home visit completed but will then be done with the study regardless of their home visit results. * Not currently known to be pregnant; individuals known to be pregnant and otherwise eligible for the study can be enrolled once no longer known to be pregnant. Participants who report being pregnant AFTER randomization can remain in the study. * Individuals receiving active cancer treatment. Participants who report starting active cancer treatment AFTER randomization can remain in the study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03104543

{ "NCT_ID" : "NCT01768910", "Brief_Title" : "Supraspinal Control of Lower Urinary Tract Function in Healthy Controls and Patients With Bladder Dysfunction", "Official_title" : "The Bladder and the Brain - Investigation of the Supraspinal Neural Control of Lower Urinary Tract Function in Healthy Subjects and Patients With Neurogenic and Non-neurogenic Bladder Dysfunction Using Advanced Neuroimaging Techniques", "Conditions" : ["Neurogenic Lower Urinary Tract Dysfunction", "Multiple Sclerosis", "Overactive Bladder", "Spinal Cord Injury"], "Interventions" : ["Other: fMRI", "Other: bladder filling", "Other: bladder cooling", "Other: additional post-treatment fMRI scan"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "FACTORIAL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-07-17", "Study_Completion_Date(Actual)" : "2018-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-01-08", "First_Posted(Estimated)" : 2013-01-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-01-14", "Last_Update_Posted(Estimated)" : 2019-03-18", "Last_Verified" : 2019-03" } }}

#Study Description Brief Summary The purpose of this study is to provide profound insight into the supraspinal neuronal mechanisms and networks responsible for lower urinary tract (LUT) control and to verify, amend or adjust neuronal circuitry models established from findings in healthy subjects in the context of neurogenic and non-neurogenic LUT dysfunction. Detailed Description The subject recruitment will be performed within the Neuro-Urology outpatient clinic at the Balgrist University Hospital and in collaboration with the Departments of Neurology, Urology and Gynecology at the University Hospital Zürich. The following subject groups will be recruited: 1) healthy controls (n=22), Non-neurogenic overactive bladder (NNOAB) patients (n=20), multiple sclerosis (MS) patients with OAB (n=15), MS patients without OAB (n=15), spinal cord injury (SCI) patients with neurogenic detrusor overactivity (n=24). After inclusion, all subjects and patients will undergo one to two functional magnetic resonance imaging (fMRI) sessions. NNOAB patients might undergo an additional fMRI session after receiving overactive bladder (OAB) treatment (such as antimuscarinics, intradetrusor injections of botulinum toxin type A). Spinal cord injury (SCI) patients with neurogenic detrusor overactivity will undergo an additional fMRI session 5-7 weeks after intradetrusor injections of botulinum toxin type A. High-resolution anatomical images and functional blood-oxygen-level-dependent (BOLD)-signal sensitive images will be acquired. In addition to the fMRI, diffusion tensor imaging (DTI) sequences will be recorded after the anatomical scans to provide information about the structural supraspinal connectivity. Study endpoints are changes of the BOLD signal in regard to location and intensity, structural and functional connectivity (FC) between previously described supraspinal centers involved in LUT control, and statistical differences of changes in BOLD signals, structural and functional connectivity between patients and healthy controls. All acquired fMRI data will be transferred to an off-line workstation running BrainVoyager QX or Statistical Parametric Mapping (SPM) Version 8. The functional data will be pre-processed for motion correction, spatial smoothing, linear trend removal, and temporal high-pass filtering. With both programs statistical analysis and graphical presentation of the results can be performed. The DTI records will be evaluated with SPM8, BrainVoyager QX or other programs like Functional Magnetic Resonance Imaging of the Brain (FMRIB) Software Library (FSL) and DTI-Studio. To estimate FC we will use SPM8 or the brain connectivity toolbox. Both softwares allow the estimation of rest- and task-related connectivity on single subject and group level with corrected statistical threshold. Overall, 96 subjects for the main study are estimated to be sufficient to demonstrate significant differences between groups. #Intervention - OTHER : fMRI - 2 measurements using functional magnetic resonance imaging in a 3T scanner - OTHER : bladder filling - Repetitive retrograde bladder filling via transurethral catheter with different filling volumes using body warm saline during each of the fMRI measurements. - OTHER : bladder cooling - Retrograde bladder filling via transurethral catheter with 4-8°C saline during each of the fMRI measurements. - OTHER : additional post-treatment fMRI scan - Should NNOAB or SCI patients receive a study independent OAB therapy by their treating physician after the 2nd fMRI scan, they will be invited for an additional third fMRI scan.

#Eligibility Criteria: Inclusion Criteria: Healthy controls * Right handed * MR suitability * Written informed consent * unimpaired LUT function MS patients with OAB * Right handed * MR suitability * Written informed consent * diagnosis of MS according to the McDonald criteria * Expanded Disability Status Scale (EDSS) <= 6 * OAB symptoms since > 6 months * >= 3 episodes of urinary urgency * frequency > 8/24h * with or without detrusor overactivity MS patients without OAB * Right handed * MR suitability * Written informed consent * diagnosis of MS according to the McDonald criteria * Expanded Disability Status Scale (EDSS) <= 6 Patients with NNOAB * Right handed * MR suitability * Written informed consent * idiopathic OAB symptoms since > 6 months * >= 3 episodes of urinary urgency * frequency > 8/24h * refractory to antimuscarinic treatment for >= 1 month * indication for intradetrusor injections of Botulinumtoxin Type A * willingness and ability to perform self-catheterization SCI patients with neurogenic detrusor overactivity * Right handed * MR suitability * Written informed consent * neurogenic detrusor overactivity due to SCI * indication for intradetrusor injections of botulinum toxin type A Exclusion Criteria: Healthy controls * impaired LUT function * pregnancy or breast feeding * no informed consent * any craniocerebral injury or surgery * any permanent ferromagnetic implant * any previous surgery of the LUT or genitalia * any anatomical anomaly of the LUT or genitalia * any LUT malignancy * postvoid residual urine volume (PVR) > 150ml * current urinary tract infection * any LUT symptoms * >= 3 episodes of urinary urgency * frequency > 8/24h MS patients with OAB * pregnancy or breast feeding * any permanent ferromagnetic implant * any neurological or psychological disease despite MS * any craniocerebral injury or surgery * any previous surgery of the LUT or genitalia * any anatomical anomaly or malignancy of the LUT or genitalia * any metabolic disease * PVR > 150ml * any concomitant treatment for the LUT (e.g. neuromodulation) * Stress urinary incontinence * any condition other than MS that might explain OAB symptoms * current urinary tract infection * indwelling catheters or the necessity to perform self-catheterization MS patients without OAB * pregnancy or breast feeding * any permanent ferromagnetic implant * any neurological or psychological disease despite MS * any craniocerebral injury or surgery * any previous surgery of the LUT or genitalia * any anatomical anomaly or malignancy of the LUT or genitalia * any metabolic disease * PVR > 150ml * any concomitant treatment for the LUT (e.g. neuromodulation) * Stress urinary incontinence * any LUT symptoms * >= 3 episodes of urinary urgency * frequency > 8/24h * indwelling catheters or the necessity to perform self-catheterization * detrusor overactivity * current urinary tract infection Patients with NNOAB * pregnancy or planned within next 8 months, breast feeding * any permanent ferromagnetic implant * any neurological, psychological, metabolic or cardiovascular disease * any craniocerebral injury or surgery * any previous surgery of the LUT or genitalia within the last year or that is related to the OAB symptoms * any anatomical anomaly or malignancy of the LUT or genitalia * PVR > 150ml * Stress urinary incontinence * indwelling catheters or the necessity to perform self-catheterization * any concomitant treatment for the LUT (e.g. neuromodulation) * current urinary tract infection SCI patients with neurogenic detrusor overactivity * pregnancy or breast feeding * any permanent ferromagnetic implant * any neurological or psychological disease despite SCI * any craniocerebral injury or surgery * any previous surgery of LUT of genitalia * any anatomical anomaly or malignancy of the LUT or genitalia * any metabolic disease * any concomitant treatment for the LUT (e.g. neuromodulation) * current urinary tract infection Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT01768910

{ "NCT_ID" : "NCT03290443", "Brief_Title" : "A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.", "Official_title" : "A Phase 1, Open-Label Single-Dose Study to Assess the Pharmacokinetics of Enasidenib (AG 221, CC 90007) in Subjects With Moderate and Severe Hepatic Impairment.", "Conditions" : ["Hepatic Impairment"], "Interventions" : ["Drug: Enasidenib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-09-21", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-10-26", "Study_Completion_Date(Actual)" : "2018-10-26}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-09-19", "First_Posted(Estimated)" : 2017-09-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-09-19", "Last_Update_Posted(Estimated)" : 2020-07-17", "Last_Verified" : 2020-07" } }}

#Study Description Brief Summary This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease Detailed Description Subjects will be enrolled in Groups 1 through 4 as follows: * Group 1: Approximately 6 to 8 male and female subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 1. * Group 2: Approximately 6 to 8 healthy male and female subjects with normal hepatic function will be enrolled in Group 2. Subjects in Group 2 will be matched to subjects in Group 1 with respect to sex, age (± 10 years), and weight (± 30 pounds). * Group 3: Approximately 6 to 8 male and female subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 3. * Group 4: Approximately 6 to 8 healthy male and female subjects with normal hepatic function will be enrolled in Group 4. Subjects in Group 4 will be matched to subjects in Group 3 with respect to sex, age (± 10 years), and weight (± 30 pounds). This study employs a staged design as follows. * At least 4 subjects with moderate hepatic impairment must demonstrate satisfactory safety and tolerability for up to 8 days after dosing, before subjects with severe hepatic impairment may be dosed. * Two subjects with severe hepatic impairment must demonstrate satisfactory safety and tolerability for up to 8 days after dosing, before the remaining subjects with severe hepatic impairment may be dosed. #Intervention - DRUG : Enasidenib - 100 mg enasidenib (CC-90007) - Other Names : - AG-221, AG-221 mesylate, AGI-12910, AGI-12910 mesylate, CC-90007, IDHIFA

#Eligibility Criteria: Inclusion Criteria: Inclusion Criteria for all subjects (Group 1, 2, 3, and 4) Each subject must satisfy all of the following criteria to be enrolled in the study: Key inclusion criteria: * Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. * Subject is male, or non-pregnant and non-nursing female between >= 40 and <= 65 years at the time of signing the ICF. * Subject has body mass index (BMI) >= 18 and <= 40 kg/m2 at screening. * Subject has seated systolic blood pressure (BP): 90 to 160 mmHg, seated diastolic BP: 50 to 100 mmHg, and pulse rate: 40 to 100 bpm. * Female subjects NOT of childbearing potential must: a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone [FSH] level of > 40 IU/L at screening). * Females of childbearing potential (FCBP)1 must have a negative pregnancy test at the Screening and Baseline Visits. While receiving IP and for at least 4 months after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options. * Male subjects must: a. Practice true abstinence2 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms are recommended]) during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions, and for at least 4 months after the last dose of IP, even if he has undergone a successful vasectomy. Inclusion Criteria for Subjects with Moderate or Severe Hepatic Impairment (Groups 1 and 3) Each subject with moderate or severe renal impairment must also meet ALL of the criteria listed below for entry: * Subject has moderate or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use. * Subject has moderate (Group 1), or severe (Group 3) hepatic impairment as defined by Child-Pugh Score. * Group 1 subjects must have moderate hepatic impairment and are required to have documentary confirmation of the diagnosis of cirrhosis made by biopsy, laparoscopy, or imaging study with a Child-Pugh score of >= 7 to <= 9, at screening. * Group 3 subjects must have severe hepatic impairment. If biopsy or laparoscopy is not performed prior to screening, subject can be included only if they have chronic liver disease and objective evidence of portal hypertension (ascites diagnosis by imaging or varices), or current medication for consequences of portal hypertension. In either case a Child-Pugh score of >= 10 to <= 13 at screening is required. * Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition: * Subject (male or female) has a QTcF value <= 480 msec at screening. * Must be stable in concomitant medication regimen (defined as not starting a new medication[s] or a change in the dosage or frequency of the concomitant medication[s] within 7 days or 5 half-lives [whichever is longer] before dosing with study drug). * Subjects may be treated with diuretics for ascites; however, subjects with severe ascites at time of enrollment may only be included at the discretion of the investigator with agreement of the Sponsor. * Subjects may have a history of encephalopathy; however, they must be on stable treatment for at least 1 month prior to screening, and must not have had an acute encephalopathic episode in the 1 months prior to screening. * Subjects must not have history of hepatorenal syndrome or hemolysis. Inclusion Criteria for a Matched Healthy Subject (Groups 2 and 4) Each matched healthy subject must meet ALL the criteria listed below for entry: * Subject must be free of any clinically significant disease that would interfere with the study evaluations. * Subject must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the Investigator and Celgene's Medical Monitor. * Subject must match a subject in Group 1 or 3, as needed with respect to sex, age (± 10 years), and weight (± 30 pounds). * Subject must be in good health as determined by past medical history, PE, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (ie, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the Investigator. * Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition: 1. If male, subject has a QTcF value <= 450 msec at screening. 2. If female, subject has a QTcF value <= 470 msec at screening. Exclusion Criteria: Exclusion Criteria for all subjects (Groups 1, 2, 3, and 4) The presence of any of the following will exclude a subject from enrollment: Key exclusion criteria * Subject has any condition or circumstance that prevents the subject from understanding and signing the ICF. * Subject has any condition that places the subject at an unacceptable risk from participating in the study or would confound the ability to interpret data from the study. * Subject has any significant medical condition or psychiatric illness that would prevent the subject from participating in the study at Investigator discretion. * Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, excretion, eg, bariatric procedure. Subjects with cholecystectomy and appendectomy may be included. * Subject is a pregnant or is breastfeeding. * Subject donated blood or plasma within 2 weeks before dose administration to a blood bank or blood donation center. * Subject has a history of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 6 months before the first dose administration, or positive alcohol screen. * Subject has a history of drug abuse (as defined by the current version of the DSM) within 6 months before the first dose administration, or positive drug screen that is not consistent with the patient's prescribed medication and or/medical history. * Subject is known to have active serum hepatitis, or have a positive result to the test for Human immunodeficiency virus (HIV) antibodies at screening. * Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are limited to hepatic involvement and its consequent comorbidities. (ie, vasculitis, clinically significant cryoglobulinemia, etc. are unacceptable). * Subject was exposed to an investigational drug (new chemical entity) within 30 days before dosing, or 5 half-lives of that investigational drug, if known (whichever is longer). * Subject used approved medications or herbal medicines that are moderate or strong cytochrome P450 (CYP)1A2 or 3A4/5 inducers and/or inhibitors (including St. John's wort) within 14 days or 5 half-lives of screening, whichever is longer. * The Indiana University 'Cytochrome P450 Drug Interaction Table' should be utilized to determine inhibitors and/or inducers of CYP1A2 and CYP3A4/5. (http://medicine.iupui.edu/clinpharm/ddis/table.aspx). * Subject will have consumed Seville oranges, grapefruit or grapefruit juice and/or pomelos, exotic citrus fruits, or grapefruit hybrids within 14 days or 5 half-lives of dosing, whichever is longer. * Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported). * Subject has a history of multiple drug allergies or drug-related anaphylaxis. * Subject has received live vaccination (excluding seasonal flu vaccination) within 90 days of dosing. * Subject is part of the staff personnel or a family member of the investigational study staff. * Subject is, for any reason, deemed by the investigator to be inappropriate for this study, including a subjects who is unable to communicate or to cooperate with the investigator or the clinical staff. Exclusion Criteria for Subjects with Moderate or Severe Hepatic Impairment (Groups 1 and 3) The presence of any of the following will exclude a hepatic impaired subject from enrollment: * Subject has any unstable medical condition occurring within 3 months prior to signing the ICF (excluding hepatic impairment and associated comorbidities per Investigator discretion). * Subject has any serious medical condition (excluding hepatic impairment and related complications), clinically significant laboratory abnormality not related to hepatic impairment and related complications, or psychiatric illness that would prevent the subject from signing the ICF and participating in the study per Investigator discretion. * Subject has hepatic encephalopathy with time- or place- disorientation, somnolence, stupor, rigidity, coma, no personality/behavior, rigidity, or hyperactive reflexes - or has had such within 1 month of screening. * Subject has a history of incipient/planned liver transplantation within 6 months of screening or has received a liver transplant. Exclusion Criteria for a Matched Healthy Subject (Groups 2 and4) Each matched healthy subject will be excluded from entry if ANY of the criteria listed below are met: * Subject has any clinically significant laboratory abnormality that in the opinion of the Investigator, is considered to prevent the subject from safely completing the study. * Subject has any unstable clinically significant illness within 3 months prior to the study. * Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. * Positive testing for any active hepatitis, or history of Hepatitis B or C. Sex : ALL Ages : - Minimum Age : 40 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03290443

{ "NCT_ID" : "NCT02570074", "Brief_Title" : "PK/PD and Safety/Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adults", "Official_title" : "Phase I Study to Evaluate Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of Two Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adult Participants", "Conditions" : ["Healthy Subjects"], "Interventions" : ["Drug: Fosfomycin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09", "Study_Completion_Date(Actual)" : "2016-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-10-06", "First_Submitted_that_Met_QC_Criteria" : 2019-07-09", "First_Posted(Estimated)" : 2015-10-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-10-06", "Last_Update_Posted(Estimated)" : 2019-07-30", "Last_Verified" : 2019-07" } }}

#Study Description Brief Summary Oral dosage regimens for fosfomycin tromethamine (Monurol™) are not established for the treatment of cUTI. The most common and recommended adult dosage regimen in the literature is a single-dose sachet containing the equivalent of 3 grams of fosfomycin administered every other day (QOD) for a total of three doses. There are a myriad of different oral fosfomycin dosing regimens currently being used in clinical practice, including up to 3 grams orally twice daily for 7-21 days, but these regimens are not based on solid pharmacokinetic, pharmacodynamic or safety rationale. Initial pharmacokinetic studies performed with oral fosfomycin tromethamine primarily examined single dose regimens and did not use modern day bioanalytical or pharmacokinetic techniques. As the use of fosfomycin becomes more pervasive in concordance with the increase in multidrug resistant pathogens, further pharmacokinetic and safety data are needed for more intensive dosing regimens to support its continued use. The rationale of this study is that oral fosfomycin tromethamine requires a modern pharmacokinetic-pharmacodynamic study to identify alternative oral dosage regimens that are appropriate and safe. This study provided safety/tolerability and clinical pharmacology information regarding two oral dosing regimens that may have application to treat various types of infections involving resistant pathogens or when other oral antibacterial options are not available. Detailed Description The study was designed as a randomized, two-way crossover trial involving up to 24 randomized participants with an anticipated drop-out rate no higher than 25% to give a total of 18 evaluable healthy adult participants. The study was fully explained to each participant, informed consent was obtained, and an IRB-approved informed consent form was signed before any study procedures were initiated. All participants underwent screening assessments within 30 days prior to the initial dosing to determine their eligibility for enrollment into the study. All participants met the inclusion and exclusion criteria and underwent screening procedures that included a complete medical history, physical examination, assessment of clinical laboratory parameters (chemistry and hematology), ECG, and pregnancy test (females of child bearing potential only). Randomization was stratified by gender, using permuted blocks. Within each gender, eligible participants were randomized with equal probability to one of the 2 treatment sequences shown in Table 3. According to the sequence to which the participant was randomized, the participant initially received one of two oral dosage regimens of fosfomycin: 3 g every other day x 3 doses or 3 g once-daily x 7 doses. After completion of the initial dosing regimen each participant was crossed over to receive the other dosing regimen. There was a minimum 5-day, and a recommended maximum 14-day, washout period prior to starting the next dosing regimen. Blood and urine samples were collected throughout the study as well as detailed drug administration and adverse event data for each participant. Fosfomycin tromethamine sachet (Monurol™) was used in this study. Each participant was instructed how to stir and dissolve the single-dose sachet into 3 to 4 ounces of water, and take each dose immediately after dissolving in water. Compliance was assessed by participant interviews (every 2 days) and counting of empty of sachets. Participants reported to the outpatient study center on Day -30 to -1 for study criteria review, clinical assessment, and blood collection for screening laboratory tests prior to fosfomycin administration. Each participant participated in the study up to 120 days (i.e., screening visit; day -1 for clinical assessment and blood collection; days 1-7 for fosfomycin administration and sample collection period; and day 8-10 for follow-up assessment; crossed over to receive the other dosing regimen and schedule of events. #Intervention - DRUG : Fosfomycin - Broad spectrum antibiotic

#Eligibility Criteria: Inclusion Criteria: * The participant is healthy as judged by the site investigator with no clinically significant abnormality identified on a medical evaluation including history, physical examination, laboratory tests, blood pressure, and heart rate. * Male and female participants between 18 <= age <= 55 old. * Female participants of childbearing potential (not surgically sterilized and between menarche and one-year post-menopause) must have a negative pregnancy test at the time of enrollment and must agree to use appropriate contraception for as long as they are taking the study drug and for 1 month afterwards. During the screening visit, participants will be instructed to use a second reliable method of birth control in accordance with the protocol during the study and for one month following. Medically acceptable contraceptives include: * Surgical sterilization (such as a tubal ligation or hysterectomy) * Approved hormonal contraceptives (such as birth control pills, patches, implants or injections) * Barrier methods (such as a condom or diaphragm) used with a spermicide, or * An intrauterine device (IUD). i. NOTE: Contraceptive measures such as Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use. * Nonsmokers defined as abstinence from cigarette smoking for the previous 6 months before enrollment into the study. * Provide a signed and dated written informed consent prior to any study-specific procedures (including screening procedures). * Body weight >=50 kg * Body mass index (BMI) 18.5 <= age <= 29.9 kg/m2 Exclusion Criteria: * History of significant hypersensitivity reaction or intolerance to fosfomycin tromethamine that in the opinion of the site investigator, contraindicates participation in the study. In addition, if heparin is used during pharmacokinetic sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled. * History of significant cardiac, neurological, thyroid, muscular, or immune disorder. * Any laboratory abnormality grade 2 or higher as defined according to the U.S. Department of Health and Human Services common terminology criteria for AEs (CTCAE).26 * Estimated creatinine clearance (CLCR) <60 ml/minute as determined by Cockcroft-Gault equation * Positive serum pregnancy test. * Currently breast feeding. * History of alcohol or substance abuse or dependence within 6 months of the screening: History of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men. 1 drink is equivalent to 12g alcohol = 5 oz (150 mL) of wine or 12 oz (360 mL) of beer or 1.5 oz (45 mL) of 80 proof distilled spirits. * The use of prescription (except birth control pills or hormone replacement in females) or non-prescription drugs, including herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of site investigator the medication will not interfere with the study procedures or compromise participant safety. * The participant has participated in a clinical trial and has received a drug or a new chemical entity within 30 days prior to the first dose of study medication. * Participants who have donated blood to the extent where participation in the study would result in excess of 500 mL blood donated within a 56 day period. * Those who, in the opinion of the site investigator, have a risk of non-compliance with study procedures. * QTc interval with Fredericia correction >450ms or any other clinically relevant ECG abnormalities Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02570074

{ "NCT_ID" : "NCT00862641", "Brief_Title" : "A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease", "Official_title" : "A Phase 4, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD).", "Conditions" : ["Asthma", "Coronary Artery Disease", "Pulmonary Disease, Chronic Obstructive"], "Interventions" : ["Drug: Placebo", "Drug: Regadenoson"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-10", "Study_Completion_Date(Actual)" : "2009-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-03-15", "First_Submitted_that_Met_QC_Criteria" : 2010-11-15", "First_Posted(Estimated)" : 2009-03-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-03-15", "Last_Update_Posted(Estimated)" : 2012-09-18", "Last_Verified" : 2012-09" } }}

#Study Description Brief Summary This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease. #Intervention - DRUG : Regadenoson - IV - Other Names : - CVT3146, Lexiscan - DRUG : Placebo - IV

#Eligibility Criteria: Inclusion Criteria: * Subject has asthma or stable chronic obstructive pulmonary disease (COPD). * Subject has a diagnosis of coronary artery disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity Body Mass Index (BMI > 30). * Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration. * Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson. * Subject is able to safely abstain from theophylline for 12 hours prior to the Day 1 visit, as determined by the Investigator * Asthma subject's frequency and severity of symptoms have remained unchanged within 30 days prior to study drug administration * Asthma subject has FEV1 >=60% predicted * COPD subject has FEV1/FVC < 0.70 Exclusion Criteria: * Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete. * Subject started on a course of corticosteroids, steroid combination with long-acting Beta2-agonist (LABA) (oral or inhaled) or anticholinergic, or has undergone a change in dose of such medications <= 30 days prior to study drug administration (subject on a stable dose of such medications for > 30 days prior to study drug administration is allowed). * Subject started leukotriene antagonists (e.g., montelukast), cromones (e.g., cromolyn sodium) or 5-lipoxygenase antagonists (e.g. zileuton or zyflo) or has undergone a change in dose of medications in these drug classes <= 7 days prior to study drug administration (subject on a stable dose of these medications for > 7 days prior to study drug administration is allowed). * Subject has a history of second or third degree heart block or sinus node dysfunction unless the subject has a functioning pacemaker. * Subject has symptomatic hypotension (temporary and reversible conditions that no longer exist are allowed). * Subject is allergic or intolerant to aminophylline. * Subject has had a respiratory infection within 2 weeks prior to randomization. * Subject has had surgery within 3 months prior to randomization. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00862641

{ "NCT_ID" : "NCT02680262", "Brief_Title" : "Self-sampling for Non-participants in an Organised Cervical Cancer Screening Programme", "Official_title" : "A Three-armed Randomised Controlled Trial of Non-participants in an Organised Cervical Cancer Screening Programme", "Conditions" : ["Cervical Cancer"], "Interventions" : ["Behavioral: HPV self-sampling kit on demand", "Behavioral: Second reminder", "Behavioral: HPV self-sampling kit mailed directly"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-10", "Study_Completion_Date(Actual)" : "2018-02-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-01-27", "First_Posted(Estimated)" : 2016-02-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-02-08", "Last_Update_Posted(Estimated)" : 2018-10-16", "Last_Verified" : 2018-10" } }}

#Study Description Brief Summary The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening. Detailed Description The CHOice trial is a parallel randomised controlled, open label trial. Participants will be equally randomised into three arms: 1) Directly mailed a second reminder including a HPV self-sampling kit; 2) Mailed a second reminder offering a HPV self-sampling kit, to be ordered by e-mail, by text message, by phone, or by website; and 3) Mailed a second reminder for a conventional practitioner-collected sample (control group). #Intervention - BEHAVIORAL : HPV self-sampling kit mailed directly - Women in intervention group 1 will be mailed a modified second reminder, a leaflet entitled Information about HPV self-sampling, and a self-sampling kit. The leaflet provides information about HPV and cervical cancer including benefits and harms about HPV self-sampling compared to regular screening. The kit includes a brush device (Evelyn Brush, Rovers Medical Devices B.V, Oss, Netherlands) to collect a cervico-vaginal sample for subsequent hrHPV testing, written and drawn instructions on how to obtain and mail the sample, and a pre-stamped return envelope addressed to the Department of Pathology, Randers Regional Hospital performing the hrHPV testing. - BEHAVIORAL : HPV self-sampling kit on demand - Women in intervention group 2 receive the same material as arm 1, except for the kit, which will only be mailed to the women on demand. Additionally, the leaflet for this group contains information on how to order the kit. The modified second reminder in both intervention groups informs of the opportunity to collect a self-sample if wanted, but also about the opportunity to have a conventional specimen taken at a general practitioner (usual procedure). - BEHAVIORAL : Second reminder - The standard second reminder informs women about the ongoing opportunity to have a conventional cervical sample taken by a general practitioner. (control group)

#Eligibility Criteria: Inclusion Criteria: * Women resident in the Central Denmark Region who have not participate in cervical cancer screening after an invitation and one reminder Exclusion Criteria: * Women younger than 30 years are not included due to the lower specificity of HPV DNA tests in younger women Sex : FEMALE Ages : - Minimum Age : 30 Years - Maximum Age : 64 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT02680262

{ "NCT_ID" : "NCT03850327", "Brief_Title" : "BIO|CONCEPT.BIOMONITOR III", "Official_title" : "BIO|CONCEPT.BIOMONITOR III", "Conditions" : ["Atrial Fibrillation", "Syncope", "Tachyarrhythmia"], "Interventions" : ["Device: BIOMONITOR III"], "Location_Countries" : ["Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-03-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-10-06", "Study_Completion_Date(Actual)" : "2019-10-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-02-11", "First_Posted(Estimated)" : 2019-02-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-02-20", "Last_Update_Posted(Estimated)" : 2021-05-27", "Last_Verified" : 2018-12" } }}

#Study Description Brief Summary The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed. #Intervention - DEVICE : BIOMONITOR III - Patients with ICM indication receive a third-generation implantable cardiac monitor

#Eligibility Criteria: Inclusion Criteria: * Patient is at high risk of developing a clinically important cardiac arrhythmia; or Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure. * Patient is able to understand the nature of study and has provided written informed consent. * Patient is willing and able to perform all follow up visits at the study site. * Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept. Exclusion Criteria: * Patients implanted with ICD or pacemaker. * Patient is pregnant or breast feeding. * Patient is less than 18 years. * Patient is participating in another interventional clinical investigation * Patient´s life-expectancy is less than 6 months. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03850327

{ "NCT_ID" : "NCT04121000", "Brief_Title" : "Patient Controlled Erector Spinae Block at VATS", "Official_title" : "Effects of Patient Controlled Erector Spinae Block on Postoperative Pain in Video Assisted Thoracoscopic Surgery (VATS) : A Randomized Controlled Study", "Conditions" : ["Postoperative Pain"], "Interventions" : ["Procedure: VIDEO ASSISTED THOTACOSOPIC SURGERY"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-06-25", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-11-01", "Study_Completion_Date(Actual)" : "2020-12-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-10-02", "First_Posted(Estimated)" : 2019-10-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-10-07", "Last_Update_Posted(Estimated)" : 2021-06-02", "Last_Verified" : 2021-05" } }}

#Study Description Brief Summary In this study our aim is to investigate the effects of continue erector spinae block on postoperative pain in patients who underwent thoracoscopic surgery. Detailed Description Open thoracic surgeries are very painful procedures. After these procedures multimodal analgesia methods such as NSAIDs, opioids, PCA (patient-controlled analgesia), infiltration analgesia and thoracal epidural block are frequently used. Of these methods thoracal epidural block is the gold standart, however this technique is very invasive and has a high risk for complications. Lately Video Assisted Thoracoscopic Surgery (VATS) has become more popular because it reduces the hospital stay and is less invasive, hence the thoracic epidural block for postoperative pain has become more questionable. In this study we aimed to investigate the effects of continue Erector Spinae Block (ESB) on postoperative pain after VATS. The study will include 80 patients. 40 patients will receive ultrasound (USG) guided ESB and 40 patients will receive PCA. All patients will recive IV Midazolam (0.05mg/kg) premedication. Standard monitorization of EKG, non- invasive blood pressure and pulsoximeter will be done and recorded in every 5 minutes. Fentanyl (1-2 µg/kg), Propofol (2-3 mg/kg) and Rocuronyum (0,5-0,8 mg/kg) will be given in induction of general anesthesia. Volume -controlled ventilation will be secured to have the values O2 saturation \>98% and en-tidal carbondioxide 30-35 mm-Hg. For the mainentanance of general anesthesia the minimal alveolar concentration of sevoflurane will be 1. After the surgery every patient will receive 1 gr paracetemol and 100 mg tramadol for postoperative pain. Furthermore every patient will receive 8 mg ondansetrone for postoperative nausesa. After sedation and standard monitorization, 20 minutes before the induction and in the prone position the Erecor Spinae Block (ESB) procedure will be done. 10 % povidone - iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done at the 8th thoracic vertebra line. The USG probe will be replaced 2-3 cm lateral to the spinous process in sagittal plane. When the erector spinae muscle is identifed in the USG the needle will be guided caudally. 0.5-1 ml local anesthetics will be given in order to confirm the needle is in the right place. After confirmation with 20 mL %0.25 bupivacaine the procedure will be performed. The patients' VAS scores will be evaluated at the 1st,3rd, 6th, 12th, and 24th hours and will be recorded. #Intervention - PROCEDURE : VIDEO ASSISTED THOTACOSOPIC SURGERY - VATS

#Eligibility Criteria: Inclusion Criteria: * Ages between 20- 75 * ASA (American Society of Anesthesiologists) Score I-III * Undergoing elective Video Assisted Thoracic Surgery Exclusion Criteria: * ASA Score IV and higher * Patinets with neurological deficits * Paitents who have major vascular damage at the same side * Mentally retarded patients * Patients with alcohol or drug addiction * Patients who are allergic to local anesthetics * Pregnancy * Paitents with coagulopathy * Patients with skin infection at the side of the procedure * Patients with pneumothorax at the side of the procedure * Patient with a pacemaker Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT04121000

{ "NCT_ID" : "NCT01146808", "Brief_Title" : "Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver", "Official_title" : "Prevention of de Novo Hepatitis B Infection With Adefovir Dipivoxil (ADV) and Hepatitis B Vaccination in HBsAg Seronegative Recipients of Liver Grafts From Hepatitis B Core Antibody Positive (HBcAb+) Donors", "Conditions" : ["Hepatitis B", "Liver Transplantation"], "Interventions" : ["Drug: Adefovir dipivoxil and hepatitis B vaccination"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2006-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-09", "Study_Completion_Date(Actual)" : "2012-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-06-16", "First_Submitted_that_Met_QC_Criteria" : 2017-01-25", "First_Posted(Estimated)" : 2010-06-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-06-17", "Last_Update_Posted(Estimated)" : 2021-08-10", "Last_Verified" : 2021-08" } }}

#Study Description Brief Summary The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). The second objective is to evaluate the efficacy of accelerated vaccination with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long antiviral therapy. Detailed Description The investigators will conduct a prospective, open-label study of Hepatitis B naive patients who received HBcAb + livers and adefovir prophylaxis post-transplant. At one year to 18 months following transplantation, all study patients will then be vaccinated with standard Hepatitis B vaccine at double dose on a monthly basis for three months, at which point they will be tested for Hepatitis B surface antibody (HBsAb). Any study patients that have developed a sufficient antibody response (HBsAb \>500 IU) will be given the option to discontinue anti-viral treatment in a monitored setting. #Intervention - DRUG : Adefovir dipivoxil and hepatitis B vaccination - Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose - Other Names : - Hepsera

#Eligibility Criteria: Inclusion Criteria: * Recipients who do not have evidence of hepatitis B surface antigen, regardless of HBcAb and HBsAb status, who: 1. received liver transplantation with hepatitis B core antibody positive (and HBsAg negative) grafts, 2. received adefovir treatment post transplantation, and 3. who have not reached the 18 month post transplantation time period. Exclusion Criteria: * Recipients with hepatitis B surface antigen positivity prior to liver transplant. * Grafts from hepatitis B surface antigen positive patients. * Previous intolerance to ADV therapy * Recipients with pre-transplant creatinine > 1.6 mg/dL * Patients younger than 21 years * Patients who are pregnant or breastfeeding Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01146808

{ "NCT_ID" : "NCT02269202", "Brief_Title" : "Pharmacokinetics of Midazolam, With and Without Concomitant Administration of Crobenetine in Healthy Male Subjects", "Official_title" : "Pharmacokinetics of 7.5 mg Midazolam, Given Orally With and Without Concomitant Administration of 175 mg Crobenetine, Given as a 6 Hrs i.v. Infusion (One Hour Loading Dose Directly Followed by a Five Hours Maintenance Dose). A Randomised, Single Blind, Two-way Crossover Trial in Healthy Male Subjects", "Conditions" : ["Healthy"], "Interventions" : ["Drug: Placebo", "Drug: Midazolam, tablet", "Drug: Crobenetine, i.v. infusion"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2002-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2002-04", }, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-10-16", "First_Posted(Estimated)" : 2014-10-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-10-20", "Last_Update_Posted(Estimated)" : 2014-10-21", "Last_Verified" : 2014-10" } }}

#Study Description Brief Summary To assess the pharmacokinetics of midazolam with/without concomitant administration of crobenetine #Intervention - DRUG : Midazolam, tablet - DRUG : Crobenetine, i.v. infusion - DRUG : Placebo

#Eligibility Criteria: Inclusion Criteria: * All participants in the study should be healthy males, range from 21 <= age <= 50 of age and their bodymass index (BMI) be within 18.5 to 29.9 kg/m2 Exclusion Criteria: * Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * History of relevant orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections * History of allergy/hypersensitivity (including drug allergy), which is deemed relevant to the trial as judged by the investigator * Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study (except substitution therapy regarding thyroid gland) * Use of any drugs that might influence the results of the trial (within one week prior to administration or during the trial) * Participation in another trial with an investigational drug (within two months prior to administration or during the trial) * Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) * Inability to refrain from smoking on trial days * Alcohol abuse (> 60 g/day) * Drug abuse * Blood donation (>= 100 mL, within four weeks prior to administration or during the trial) * Excessive physical activities (within the last week before the study) * Any laboratory value outside the reference range of clinical relevance Sex : MALE Ages : - Minimum Age : 21 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02269202

{ "NCT_ID" : "NCT03947216", "Brief_Title" : "Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease.", "Official_title" : "Study of Pimavanserin Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease", "Conditions" : ["Parkinson Disease"], "Interventions" : ["Procedure: Cardiac monitoring", "Behavioral: Assessment of severity of Parkinson Disease", "Behavioral: Assessment of severity of ICD (impulse control disorders)", "Procedure: Blood analysis", "Behavioral: Assessment of quality of life", "Drug: Placebo: 2 tablets containing same excipients except active compound", "Behavioral: Assessment of cognition", "Behavioral: Assessment of depression", "Behavioral: Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors", "Drug: Active drug: pimavanserin 17mg (2 strength tablets)"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-10-23", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-04-23", "Study_Completion_Date(Actual)" : "2024-06-17}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-05-07", "First_Posted(Estimated)" : 2019-05-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-05-10", "Last_Update_Posted(Estimated)" : 2025-01-01", "Last_Verified" : 2024-12" } }}

#Study Description Brief Summary There is no consensus on the treatment of Impulse Control Disorder (ICD) in Parkinson Disease (PD) though it is recommended to reduce the dosage of dopamine agonists (DA). Reduction of DA frequently leads to a worsening of motor signs (parkinsonism or dyskinesias due to the concomitant increase of levodopa doses) and non-motor signs with the appearance of a DA withdrawal syndrome (DAWS). Chronic stimulation of the sub-thalamic nuclei may reduce ICD but is restricted to a minority of patients and cases of new-onset ICD symptoms post stimulation have been reported. The benefit of amantadine in pathological gambling is controversial and the efficacy of clozapine has been reported in a few cases but with serious safety limitations. Very recently, naltrexone did not significantly improve ICD. Thus, an efficacious and safe treatment of ICD in PD remains an unmet need for clinical practice. Recently, it has been reported that pimavanserin, a selective serotonin 5-HT2A inverse agonist with a satisfactory safety profile without motor side effects, was efficient in improving psychosis, insomnia and day-time sleep in PD. Pimavanserin, marketed under the tradename NUPLAZID® was approved in 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The link between serotonin and ICD has been well established, since the enhancement of 5HT2A receptors stimulation is associated to ICD, since serotonin modulates mesolimbic dopaminergic reward system transmission and given that serotonin neurotransmission is increased during chronic intake of dopamine agonist such as pramipexole which is well-known to induce ICD in PD patients. Thus, there is a large body of evidence suggesting that the decrease of the 5HT2A activity could be efficient in reducing ICD in PD. This further supports the concept of testing the efficacy of pimavanserin (a selective 5HT2A inverse agonist) for treating ICD in PD. Our aim is to conduct a study evaluating the efficacy and safety of pimavanserin on ICD in PD. This clinical trial is conducted with the support of the French NS-Park/FCRIN (French Clinical Research Infrastructure Network) network. #Intervention - DRUG : Active drug: pimavanserin 17mg (2 strength tablets) - Pimavanserin 17mg (2 strength tablets) will be taken orally daily from day 1 to Visit 4 (Week 8) - DRUG : Placebo: 2 tablets containing same excipients except active compound - Placebo (2 strength tablets) will be taken orally daily from day 1 to Visit 4 (Week 8) - BEHAVIORAL : Assessment of severity of ICD (impulse control disorders) - Questionnaire for impulsive-compulsive disorders in Parkinson's disease rating scale (QUIP-RS) will be administrated at day 0, day 28 (Week 4) and day 56 (Week 8) - BEHAVIORAL : Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors - Hyper- and hypodopaminergic behaviors (Ardouin's scale); Movement disorders society sponsored unified Parkinson's disease rating scale (MDS-UPDR), and daytime and night time sleep by scale for outcomes in Parkinson's disease SLEEP (SCOPA-SLEEP, ISI, PDSS-2) will be administrated at day 0, day 28 (Week 4) and day 56 (Week 8) - BEHAVIORAL : Assessment of quality of life - Parkinson's Disease questionnaire (PDQ-39) will be administrated at day 0, day 28 (Week 4) and day 56 (Week 8) - BEHAVIORAL : Assessment of depression - Montgomery-Åsberg Depression Rating Scale (MADRS) will be administrated at day 0 and day 56 (week 8) - BEHAVIORAL : Assessment of cognition - Cognitive state of patients by Montreal Cognitive Assessment (MOCA) will be assessed at day 0. - BEHAVIORAL : Assessment of severity of Parkinson Disease - Clinical Global Impression Severity scale (CGIS) will be administrated at day 0 , day 7, day 14, day 28, day 42 and day 56 (week 8) and day 112 (Week 16) - PROCEDURE : Blood analysis - Blood sample will be collected for analyse of safety (blood count/liver and kidney functions, electrolytes) at day 0 and day 56 - PROCEDURE : Cardiac monitoring - Electrocardiogram will be realized at day 0, 28 and 56.

#Eligibility Criteria: Inclusion Criteria: * Patient with PD according to the UKPDSBB criteria for at least 1 year before randomization * Patient, man or woman, aged from 35 <= age <= 75 old * Patient with moderately severe ICD assessed by QUIP-RS (each item being rated 0 <= age <= 16) defined as: * a combined ICD total score (defined as the sum of the 4 ICD sub-scores (pathological gambling + buying + hypersexuality + eating)) superior or equal to 10 or, * at least one of the 4 ICD sub-scores in the following range: 1. 'pathological gambling' sub-score from 6 to 12 (included), 2. 'buying' sub-score from 8 to 12 (included), 3. 'hypersexuality' sub-score from 8 to 12 (included), 4. 'eating' sub-score from 7 to 12 (included) (Weintraub et al., 2012). The use of 'lower' margins will guarantee that the patient experiences behavioral disturbances severe enough to justify pimavanserin treatment. On the other hand, the use of 'upper' margins will guarantee that the patients included in the trial will not suffer from ICD severe enough to question ethically the use of placebo during the 8 weeks of the treatment. Eligibility of patients with QUIP-RS sub-scores above 12 will be assessed upon investigator's request by an adjudication committee composed by independent experts external to the study (cf IX.3 Adjudication Committee). * ICD onset after PD onset and after initiation of dopaminergic drugs * Patient treated by dopaminergic drugs for at least 3 months before randomization * Patient treated with a stable regimen of levodopa, dopamine agonists, COMT and MAOB inhibitors, amantadine, anticholinergic, antidepressant and benzodiazepine for at least 1 month before the randomization and be willing to remain on the same doses throughout the course of their participation in the trial (Papay et al., 2014) * Patient with health insurance * Patient/ guardian / curator who sign the written informed consent * For women of childbearing potential, use of an effective contraception method* for at least 1 month prior to randomization until 8 weeks after the last dose of study drug administration. Women who do not have an effective contraception* must : have had her last natural menstruation >=24 months prior to the selection visit, or have been surgically sterilized prior to the selection visit, or have had a hysterectomy prior to the selection visit. Exclusion Criteria: * Patient suffering from another parkinsonian syndrome (multiple system atrophy, progressive supranuclear palsy, Lewy body dementia, corticobasal degeneration) * Patient who have a known hypersensitivity to the study treatment, based on known allergies to drugs of the same class * Stroke, uncontrolled serious medical illness, myocardial infarction, congestive heart failure, cardiac function disorders, within 6 months before randomization * Patient with history of long QT syndrome * Patient with long QTcB detected with ECG at inclusion visit (> 450 ms) * Patient treated with antipsychotic drugs during the last three months before randomization * Patient treated with concomitant medication leading to torsade de pointes (TdP) without discontinuation >= 5 half-lives before randomization (please refer to medications list with known risks of TdP on appendix XVII.5.10 and check website https://crediblemeds.org/index.php/tools/ for the most up-to-date information) * Patient with hydro-electrolytics troubles, particularly hypokaliemia or hypocalcemia not corrected, at inclusion visit or assessed no later than 8 days before randomization. To be eligible, the patient's electrolyte values should be within the following limits: 3.5 <= K+ <= 5 mmol/L 135 <= Na+ <= 145 mmol/L 2,20 <= Ca2+ <= 2,60 mmol/L * Patient treated with a strong or moderate CYP3A4 inducer: carbamazepine, rifampicin, phenytoin, modafinil, efavirenz or a strong inhibitor of CYP3A4: azole antifungals, protease inhibitors, macrolids, without discontinuation >= 5 half-lives before randomization * Patient treated with medicinal plants interacting with CYP3A4 without discontinuation >= 5 half-lives before randomization (Echinacea (E.pupurea, E.angustifolia and E.pallida), Piperina, Artemisia, St. John's Wort and Ginkgo * Patient with Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) score < 20 (to exclude patients likely with dementia) at inclusion visit (Papay et al., 2014). * Patient suffering from severe depression or marked suicidal thoughts (score > 3 on the suicidal thoughts item of the MADRS) at inclusion visit (Papay et al., 2014) * History of DBS within the past year before randomization, or change in stimulation parameters less than one month prior to randomization * Hematologic or solid malignancy diagnosis within 5 years prior to randomization. [Note: Subjects with a history of localized skin cancer, basal cell or squamous cell carcinoma, may be enrolled in the study as long as they are cancer free prior to randomization. Subjects with other localized cancers (without metastatic spread) who have previously completed their course of treatment more than 5 years prior to randomization, are not currently receiving treatment and have been in remission may be enrolled only if, in the opinion of the Investigator, there is no expectation for recurrence or further cancer treatment during the study period. Antihormonal therapy (e.g., tamoxifen) is allowed if the subject's cancer is in remission and the subject is on stable maintenance therapy to reduce their risk of recurrence.] * Patient suffering from severe renal impairment define as CrCL<30 mL/min, Cockcroft-Gault at inclusion visit or assessed no later than 8 days before randomization * Clinically significant hepatic impairment * Concurrent participation in another research involving a drug or medical device * Patient with language barriers precluding adequate understanding or co-operation or who, in the opinion of the investigator, should not participate in the trial * Treatment with an investigational treatment within 30 days prior to randomization * Woman pregnant, nursing or of childbearing potential age without effective contraception methods* or intends to become pregnant. * an effective contraception method is defined as implants, oral oestro-progestative contraceptives or progestative which inhibit ovulation contraceptives (e.g, desogestrel), or double barrier method (condom plus spermicide or diaphragm plus spermicide) or levonorgestrel intrauterine devices, or vasectomized partner (confirmed with two negative spermograms). Sex : ALL Ages : - Minimum Age : 35 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03947216

{ "NCT_ID" : "NCT03190603", "Brief_Title" : "Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis", "Official_title" : "Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis Results From MRI Finding", "Conditions" : ["Spondylarthropathies", "Magnetic Resonance Imaging"], "Interventions" : ["Drug: Celecoxib"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Interventional_Model" : "SEQUENTIAL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-06-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-06-05", "Study_Completion_Date(Actual)" : "2018-06-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-06-15", "First_Posted(Estimated)" : 2017-06-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-06-15", "Last_Update_Posted(Estimated)" : 2018-06-06", "Last_Verified" : 2018-06" } }}

#Study Description Brief Summary Axial Spondyloarthritis (SpA) is a kind of inflammatory arthritis which includes ankylosing spondylitis. Common symptoms of axial SpA are inflammatory back pain, morning stiffness, peripheral arthritis, enthesitis. Controlling aforementioned symptoms are one of the goal in treatment, and another goal is preventing bony ankylosis of axial skeleton such as spine. Ankylosis can limit range of motion and lower the quality of life. Non-steroidal antiinflammatory drug (NSAID) and Tumor necrosis factor (TNF)-a inhibitor are the current treatment options for axial SpA. These medications can improve pain and stiffness of axial SpA patients, however preventing bony ankylosis is not proven. Current study showed attenuating inflammation at early stage could prevent further bony destruction and ankylosis in axial SpA. Present study is designed to discover the therapeutic effect of NSAID whether NSAID could recover the early inflammatory bony change (bone marrow edema at MRI) and prevent further bony change. #Intervention - DRUG : Celecoxib - Continue celecoxib 400mg/day for 3months in axial spondyloarthritis patients.

#Eligibility Criteria: Inclusion Criteria: * 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4 * definite bone marrow edema on Sacroiliac joint MRI Exclusion Criteria: * Patients who have underling cancer / infectious disease / kidney disease / liver disease / cardiovascular or cerebrovascular disease * Patients who is using TNF-a inhibitor * Patients with side effects of NSAID * Patients with history of peptic ulcer * Patients who can't keep NSAID treatment Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT03190603