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{ "NCT_ID" : "NCT02239146", "Brief_Title" : "Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass", "Official_title" : "A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass", "Conditions" : ["Acquired Bleeding Disorder", "Cardiac Surgery Requiring Cardiopulmonary Bypass"], "Interventions" : ["Drug: placebo", "Drug: catridecacog"], "Location_Countries" : ["United States", "Germany", "United Kingdom", "Canada", "Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2005-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-01", "Study_Completion_Date(Actual)" : "2008-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-09-10", "First_Posted(Estimated)" : 2014-09-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-09-10", "Last_Update_Posted(Estimated)" : 2017-01-11", "Last_Verified" : 2017-01" } }}

#Study Description Brief Summary This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB). #Intervention - DRUG : catridecacog - Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg). - DRUG : placebo - Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).

#Eligibility Criteria: Inclusion Criteria: * Subject is undergoing his/her first myocardial revascularization Exclusion Criteria: * Previous participation (randomisation and dosing) in this trial * Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE) * Subject required a pre-operative (within 30 days) transfusion of any blood and/or blood product * Subject has a current atrial fibrillation or history of atrial fibrillation Sex : ALL Ages : - Minimum Age : 35 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02239146

{ "NCT_ID" : "NCT01569451", "Brief_Title" : "Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate", "Official_title" : "A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis", "Conditions" : ["Multiple Sclerosis"], "Interventions" : ["Drug: Glatiramer Acetate", "Other: Placebo", "Drug: Rituximab"], "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)" : "2012-02", "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" : 2012-03-30", "First_Submitted_that_Met_QC_Criteria" : 2018-05-04", "First_Posted(Estimated)" : 2012-04-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-04-02", "Last_Update_Posted(Estimated)" : 2018-06-08", "Last_Verified" : 2018-06" } }}

#Study Description Brief Summary The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo rituximab induction followed by GA for the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis (RMS). Detailed Description This is a double blind, active comparator; single-center study involving up to 90 subjects with qualifying CIS or RMS. Subjects who are not screen-failures must be randomized within 60 days of signing the informed consent document. Subjects who are not randomized within these 60 days must be re-screened for enrollment into the study. Patients will be stratified based on their diagnosis of CIS or RMS (Relapsing Remitting or Secondary Progressive) and then randomly assigned at a 1:1 ratio to either rituximab induction followed by standard GA therapy (R-GA arm), or placebo induction followed by standard GA therapy (GA arm). Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab or placebo (normal saline) on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily. Study visits include screening, baseline/randomization (day 1), day 15, day 28 and then visits every 3 months for up to 2.5 years. A month is defined as 28 days. On study day 15, patients will receive the second dose of either rituximab or placebo; on study day 28 patients will begin treatment with GA therapy. Study days 15 and 28 have an acceptable window of +/- 4 days. Follow-up phone calls are conducted every month to assess adverse events and relapses. All monthly phone calls and quarterly visits must occur with a +/- 7 day window. Unscheduled office visits for the evaluation of symptoms suggestive of relapses will be scheduled as needed and may be prompted by questions elicited during the monthly safety and relapse assessment phone calls, or on the basis of a phone call initiated by the patient. In either case, those handling the phone call will interview the patient according to the questions described in the PDDS will be administered. If a subject reports new or worsening symptoms or there is a one point change in the PDDS score, an unscheduled visit will be necessary. The examining clinician will administer the Expanded Disability Status Scale (EDSS) but will be blinded to the PDDS score and type of visit (unscheduled or scheduled). The treating clinician will determine if the neurological change is considered a relapse based on EDSS scores provided by the EDSS evaluator and clinical presentation, and will make the decision whether or not corticosteroids should be administered for the treatment of a relapse. In addition, patients whose EDSS scores change sufficiently to qualify for SAD at either scheduled or unscheduled visits, will be asked to come in for an additional visit, 12 weeks later, to determine whether the change is sustained. A sub-group of patients who provide informed consent will be enrolled in the Lumbar Puncture procedure. The procedure will be performed at the beginning of the study and at the 6 month visit. The objective will be to examine changes in CSF T and B cells and correlate them with evidence of disease activity by relapse, new MRI lesions and/or SAD. This procedure is optional for patients and will have no impact on the overall study. Patients who do decide to participate will sign an Addendum for Optional Procedure Consent Form The primary endpoint will be the number of disease-free patients, defined as patients without new lesions on brain MRI using the combined unique lesion approach (CUL), without sustained change in EDSS score over any 3-month period and without relapse. Once the last patient randomized has completed the final study visit for year 1 of the study, the data will be locked and an analysis performed on all data collected up to that point. An independent Data and Safety Monitoring Board (DSMB) will meet at initiation of the study and every 6 months thereafter until the end of the study. Members of the DSMB may unblind themselves at their discretion and the DSMB will include a statistician not directly involved in this study. If induction therapy fails to show superiority at any point, the study will be stopped. Standardized brain MRIs with and without gadolinium contrast will be obtained at baseline, and month 6, 12, 18 and 24 months (for those patients reaching this point prior to the last enrolled patient reaching the 12 months follow-up visit) at UCD Anschutz Medical Campus. The treating clinician will have access to the MRI and can discuss the results openly with subjects. Standardized MRIs will be obtained and interpreted locally by a physician who will be blinded to the subject treatment to record the endpoints described above. Assessments will be performed according to the schedule of events in section 4.1. Blinded examiners will be utilized for the EDSS, MSFC and low contrast visual acuity assessments. Lab results for B cell CD19+ counts will be collected by a blinded study coordinator who will have them reviewed on a monthly basis by a qualified member of the DSMB for safety assessment. But the CD19 B cell counts will not be available to the treating clinician unless needed for safety. The treating clinician and the study coordinator will manage the clinical care and study related procedures. Complete metabolic panel (CMP) and liver function tests (LFT) will be obtained once a year as Standard of Care, or more often if deemed necessary by the treating clinician. Complete blood counts (CBC) with differential and CD19+ labs will be collected at Baseline, month 1 and every 3 months from baseline to monitor B cell recovery. The examining clinicians and primary study coordinator will be blinded to the CD19 lab results. #Intervention - DRUG : Rituximab - intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15 - Other Names : - Rituxan, MabThera - DRUG : Glatiramer Acetate - 20 mg injected subcutaneously daily - Other Names : - Copolymer 1, Cop-1, Copaxone - OTHER : Placebo - Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab or placebo (normal saline) on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.

#Eligibility Criteria: Inclusion Criteria: * 18 through 55 years * Patients with CIS demonstrating one unifocal neurological event AND at least 2 T2-weighted brain lesions measuring a minimum of 6mm in diameter by MRI analysis; or a definite diagnosis of RMS, as defined by the 2005 revised McDonald criteria(1, 2), and have had at least one clinically defined relapse within the past year OR one GEL on an MRI within the past year * Women of child-bearing potential must agree to practice an acceptable method of birth control * No evidence of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (PCNS) lymphoma * Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization * Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with local regulatory requirements. Exclusion Criteria: * >= 15 GELs on baseline MRI * Treatment with interferon β, natalizumab, or fingolimod within three months of randomization * Treatment with mitoxantrone, cyclophosphamide, or any other chemotherapeutic agent for MS or malignancy within 12 months of randomization * Attenuated live virus vaccination within 4 weeks of randomization * Positive urine and serum pregnancy test at screening or baseline visit * Any prior treatment with alemtuzumab or cladribine * Unable to tolerate GA * History of cardiac arrhythmias, angina or any other significant cardiac abnormalities * History of clinically significant chronic disease of the immune system or a known immunodeficiency syndrome (HIV) other than MS * White Blood Cell count of less than 2.5*10^9/L or lymphocyte count below 0.4*10^9/L * Positive for any evidence of past, or current, hepatitis B and/or C infection * History or presence of malignancy (except basal cell carcinoma) * Clinically significant alcohol or drug abuse within past two years * Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements * Inability to undergo MRI scans or history of hypersensitivity to gadolinium- diethylenetriamine penta-acetic acid (DTPA) * Participation in any clinical study evaluating another investigational drug or therapy within three months prior to randomization * Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study 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: No

NCT01569451

{ "NCT_ID" : "NCT02923804", "Brief_Title" : "Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients", "Official_title" : "A Randomized, Double-Blind, Placebo-Controlled Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients When Added to Standard of Care", "Conditions" : ["Non Alcoholic Fatty Liver"], "Interventions" : ["Dietary Supplement: Omega-3", "Dietary Supplement: Olive oil"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-12-01", "Study_Completion_Date(Actual)" : "2017-12-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-09-30", "First_Posted(Estimated)" : 2016-10-05" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-09-30", "Last_Update_Posted(Estimated)" : 2018-04-04", "Last_Verified" : 2016-09" } }}

#Study Description Brief Summary This study is a prospective, randomized, placebo-controlled, double-blind trial to determine the effect of high concentrate omega-3 capsules on the omega-3 status of patients with non-alcoholic fatty liver. Detailed Description Subjects with non-alcoholic fatty liver (simple steatosis) confirmed within the last year by ultrasound or other imaging modality will be recruited to the study. Subjects will be randomized to a treatment arm of high concentrate capsules or placebo for a 6 month treatment period.Omega-3 content of red blood cells (omega-3 index) will be measured for primary endpoint assessment. Quantitative MRI will be performed to determine the effect on liver fat content. #Intervention - DIETARY_SUPPLEMENT : Omega-3 - 3x 1g capsules taken daily for 6 months - DIETARY_SUPPLEMENT : Olive oil - 3x 1g capsules taken daily for 6 months

#Eligibility Criteria: Inclusion Criteria: * Documented history of clinical diagnosis of NAFLD by ultrasound, MRI or biopsy within one (1) year prior to screening (V1). If the diagnostic test date is greater than one (1) year, abdominal ultrasound will be repeated at (V1) and must confirm a diagnosis of NAFLD. * Men or women, >=18 years. * BMI between 18.0 and 39.9 kg/m2. * Non-smokers (>3 months of non-smoking). * If on a statin regimen, history (> 1 month stable dose) of taking a statin medication (HMG-CoA reductase inhibitor example: Lipitor, Zocor, Crestor, Pravachol, Lescol, Livalo, etc). * Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures. Exclusion Criteria: * Diagnosis of NASH. * Bilirubin >2x ULN. * Other causes of liver inflammation including Hepatitis A, B or C, HIV, confirmed or suspected cirrhosis, Wilson's disease, autoimmune hepatitis, hemochromatosis, alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause liver damage, or known to be hepatotoxic. * Subjects with a history of bariatric surgery. * Significant weight loss (> 5% body weight) or rapid weight loss (>1.6 kg/week), within six months of screening. * Current or recent (within six months of screening) history of significant gastrointestinal, renal, pulmonary, hepatic or biliary disease, endocrine diseases or other invasive weight loss treatments (Type II Diabetes permitted, and stable (> 3 months) thyroid disorders). * Individual taking prescription or over-the-counter medications (including dietary supplements, see Appendix 1) known to alter lipid metabolism, within four (4) weeks of randomization. These medications include (but are not limited to) the following: bile acid sequestrants, cholesterol absorption inhibitors, niacin or fibrates, * Individuals taking prescription omega-3 fatty acids. * Use of supplements including Omega-3s and Omega-6s, other oil-based supplements, phytosterols, Vitamin E, prebiotics and probiotics, or any weight loss supplements within four (4) weeks of randomization (multivitamins and minerals containing Vitamin E are permitted). * Use of systemic corticosteroids, androgens (except androgens for hypogonadism to restore normal levels), phenytoin, erythromycin and other macrolides, thiazolidinediones (e.g. pioglitazone), and thyroid hormones (except stable-dose thyroid replacement therapy for four (4) weeks prior to enrollment). * Use of the anticoagulants warfarin (Coumadin), dabigatran (Pradaxa), apixaban (Eliquis) or rivaroxaban (Xarelto). NOTE: Anti-platelet agents such as Plavix are allowed. * Pregnant or lactating women or women of childbearing potential, who are not using an approved method of contraception. A woman is considered to be of childbearing potential unless she is post-hysterectomy, one or more years postmenopausal, or one or more years post-tubal ligation. * History of significant cardiovascular or coronary heart disease (CVD or CHD) as defined by having had a coronary artery bypass procedure, coronary stent or angioplasty, or myocardial infarction in the previous six (6) months. * History of cancer, other than non-melanoma skin cancer and basal cell carcinoma, within the previous five years. * Poorly controlled or uncontrolled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=95 mmHg). * Recent history of prolonged alcohol (>3 months) use (within past 6 months) or excessive alcohol use, defined as >14 drinks per week (one drink = 12 oz. beer, 4 oz. wine, 1.5 oz. hard liquor). * Exposure to any investigational agent within four (4) weeks prior to Visit 1. * Subjects planning to undergo surgery during the study period or up to 1 month after the study * Any serious psychiatric disease or disorder, which, in the opinion of the investigator, would preclude the subject from participating in the study. * Any known intolerance to the investigational ingredients of this medical food. * Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event. 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

NCT02923804

{ "NCT_ID" : "NCT02789826", "Brief_Title" : "Laparoscopic Versus Open Resection of Cancer Stomach", "Official_title" : "Laparoscopic Versus Open Resection of Cancer Stomach Randomized Controlled Trial", "Conditions" : ["Gastric Cancer"], "Interventions" : ["Procedure: Open gastrectomy", "Procedure: Laparoscopic gastrectomy"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12", "Study_Completion_Date(Actual)" : "2020-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-05-22", "First_Posted(Estimated)" : 2016-06-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-05-29", "Last_Update_Posted(Estimated)" : 2020-09-09", "Last_Verified" : 2020-09" } }}

#Study Description Brief Summary The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy). There are two main types of techniques (open \& laparoscopic) Many studies were done comparing these two techniques showed that Laparoscopic resection is superior in early postoperative recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open resection (less safety margin \& less lymphadenectomy) but because of the ongoing advances on laparoscopic surgery these results needs more and more revision. So the investigators conduct this randomized controlled trial aiming at comparing open and laparoscopic resection of cancer stomach to choose the best surgical procedure for resection of cancer stomach. Detailed Description The surgical procedure for resection of cancer stomach aiming at resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy). # Tumor resection; Will be done by one of the following techniques: 1. laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour) 2. Open gastrectomy (according to the site of tumor). # Lymphadenectomy; Will be done according to Japanese Gastric Cancer Association guidelines for optimal lymph node dissection levels for Early Gastric Cancer (1): * D1+alpha -(perigastric lymph node dissection) for mucosal cancer, for which EMR is not indicated and for histologically differentiated submucosal cancer of \< 1.5 cm in diameter; * D1+ beta for preoperatively diagnosed submucosal cancer without lymph node metastasis (N0), for which D1+ alpha is not indicated, and for early cancer \< 2.0 cm in diameter with only perigastric lymph node metastasis (N1); * D2 for early cancer \> 2.0 cm in diameter. Follow up: all patients will be followed up clinically for the outcomes for each surgical technique. #Intervention - PROCEDURE : Laparoscopic gastrectomy - Patients allocated to the 'laparoscopic gastrectomy' arm will receive gastrectomy via laparoscopy. - Other Names : - Minimally invasive gastrectomy - PROCEDURE : Open gastrectomy - patients allocated to the 'Open gastrectomy' group will receive gastrectomy via laparotomy

#Eligibility Criteria: Inclusion Criteria: * All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1 <= age <= 3, N0 <= age <= 1, M0). Exclusion Criteria: * Pregnancy. * Infiltration to the( pancreas ,liver ,colon or vital vascular structure). * Metastasis to the (liver, lung, brain, paraaortic LN involvement). * Peritoneal deposit. * Surgically unfit patient. 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

NCT02789826

{ "NCT_ID" : "NCT01257061", "Brief_Title" : "Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment", "Official_title" : "Unicentric Comparing Effectiveness Superiority of to Clemastine Fumarate 1, 0 mg/g + Dexamethasone 0, 5 mg/g to Dexchlorpheniramine Maleate 10 mg/g in Eczema Treatment.", "Conditions" : ["Eczema"], "Interventions" : ["Drug: Group 1", "Drug: Group 2"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-09-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-04-30", "Study_Completion_Date(Actual)" : "2013-08-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-11-29", "First_Posted(Estimated)" : 2010-12-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-12-08", "Last_Update_Posted(Estimated)" : 2020-07-07", "Last_Verified" : 2020-06" } }}

#Study Description Brief Summary Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment. Detailed Description Study design: • Double blinded, superiority, prospective parallel-group, intend to treat trial. Study design: * Experiment duration: 22 days * 2 visits (days 1,7,15 and 22) * Reducing Eczema Area and severity index evaluation * Adverse events evaluation #Intervention - DRUG : Group 1 - Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion - DRUG : Group 2 - Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion

#Eligibility Criteria: Inclusion Criteria: * Patients must be able to understand the study procedures agree to participate and give written consent. * Patients with acute or sub-acute eczema. * Presence of symmetric lesions to compare on side to the other. Exclusion Criteria: * Pregnancy or risk of pregnancy. * Lactation * Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study). * Sunlight over exposure in the last 15 days. * Any pathology or past medical condition that can interfere with this protocol. Sex : ALL Ages : - Minimum Age : 5 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT01257061

{ "NCT_ID" : "NCT02897583", "Brief_Title" : "YAG Vitreolysis for Floaters", "Official_title" : "A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of YAG Vitreolysis Versus Sham for Symptomatic Weiss Ring Due to Posterior Vitreous Detachment", "Conditions" : ["Weiss Ring", "Floaters", "Posterior Vitreous Detachment"], "Interventions" : ["Procedure: YAG vitreolysis"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-08", "Study_Completion_Date(Actual)" : "2016-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-06-16", "First_Posted(Estimated)" : 2016-09-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-09-12", "Last_Update_Posted(Estimated)" : 2016-09-13", "Last_Verified" : 2016-09" } }}

#Study Description Brief Summary This is a single-center, prospective randomized controlled trial evaluating the safety and efficacy of YAG vitreolysis versus sham for symptomatic Weiss ring due to posterior vitreous detachment. Detailed Description 52 subjects will be enrolled in the trial and randomized in a 2:1 ratio to receive either YAG laser vitreolysis or sham laser for symptomatic Weiss ring due to posterior vitreous detachment. Subjects will follow up at one week, one month, three months, and six months after the procedure. Assessments will include a questionnaire regarding duration of floater symptoms prior to presentation, severity of floater symptoms, number of floaters, and activity most inconvenienced by presence of floaters; Medical, ocular history and demographics collected; ETDRS and Snellen visual acuity; Optos color photography; Heidelberg Spectralis Optical Coherence Tomography (OCT) and infrared photo; B scan ultrasound of Weiss ring with caliper measurement of nearest distance between Weiss ring and retina, Weiss ring and posterior lens capsule (only in phakic eyes); Slit lamp and indirect ophthalmoscopy with scleral depression of study eye; Applanation tonometry; Visual Functioning Questionnaire-25 (VFQ 25). Qualitative change in Optos photography will evaluated by a masked physician. #Intervention - PROCEDURE : YAG vitreolysis

#Eligibility Criteria: Inclusion Criteria: * Symptoms of floaters that correlate to the presence of a posterior vitreous detachment for at least 6 months * Documented posterior vitreous detachment on clinical examination, OCT, and B scan * Self-rating of visual disturbance by the floaters must be at least 4 on a 0 <= age <= 10 scale, with 0 being no symptoms to 10 being debilitating symptoms. * Symptomatic Weiss ring (PVD) must be at least 3 mm away from the retina and 5 mm from the posterior lens capsule of the crystalline lens, as measured on B-scan. For pseudophakic patients, there is no minimum required distance from the intraocular lens. * Able to position for the YAG laser procedure. * Accept the risks of YAG laser including but not limited to retinal detachment, intraocular hemorrhage, retinal damage, cataract formation, optic nerve damage, inflammation, and irreversible loss of vision. * Willing and able to comply with clinic visits and study-related procedures * If the patient has two symptomatic eyes, only one eye can be randomized and included in the study. * Provide signed informed consent Exclusion Criteria: * Snellen best corrected visual acuity worse than 20/50 in the fellow eye * History of retinal tear, retinal detachment, or uveitis in the study eye * History of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye * History of glaucoma or high intraocular pressure defined as having a history of glaucoma surgery or currently taking two or more topical glaucoma medications in the study eye Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT02897583

{ "NCT_ID" : "NCT02991859", "Brief_Title" : "Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects", "Official_title" : "An Escalating Dose, Randomized, Placebo-controlled, Incomplete-block, 2-period Cross-over Study to Assess the Dose Response for Topical Efficacy Via Airway Responsiveness to Adenosine-5'-Monophosphate (AMP) Challenge and the Dose Response for Systemic Activity Via 24h Plasma Cortisol Suppression and Thereby the Relative Therapeutic Index for Fluticasone Furoate (FF), Fluticasone Propionate (FP) and Budesonide (BUD) in Asthmatic Subjects", "Conditions" : ["Asthma"], "Interventions" : ["Drug: Fluticasone propionate (FP) Dry Powder Inhaler", "Drug: Placebo (ELLIPTA or DISKUS)", "Drug: Budesonide (BUD) Turbuhaler", "Drug: Fluticasone furoate (FF) Dry Powder Inhaler"], "Location_Countries" : ["Germany", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-02-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12-20", "Study_Completion_Date(Actual)" : "2018-12-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-12-09", "First_Submitted_that_Met_QC_Criteria" : 2020-03-26", "First_Posted(Estimated)" : 2016-12-14" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-12-09", "Last_Update_Posted(Estimated)" : 2020-07-31", "Last_Verified" : 2020-07" } }}

#Study Description Brief Summary This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study, aiming to investigate whether higher potency of different inhaled corticosteroid confers an improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It will compare the dose response for topical efficacy via airway responsiveness (to adenosine-5'-monophosphate \[AMP\] challenge), and the dose response for systemic activity via 24 hour plasma cortisol suppression, and thereby compare the relative therapeutic index, for the following inhaled corticosteroids: fluticasone furoate (FF), fluticasone propionate (FP) and budesonide (BUD). There will be a screening visit 4 - 42 days before the first dose of study treatment, and AMP challenge Provocative concentration 20 (PC20) of \<=80 milligrams per milliliter (mg/mL) at screening visit 2 i.e. at 4 - 14 days before the first dose of study treatment. Subjects will be randomized to one of 5 or 12 treatment sequences, and will have one or two treatment periods, each comprising 5 consecutive 7-day phases of escalating doses of either FF, FP, BUD or placebo. There will be a 25- to 42-day washout period between treatment periods. The study duration for each subject will be approximately 13 or 24 weeks including the follow-up period. #Intervention - DRUG : Fluticasone furoate (FF) Dry Powder Inhaler - Dry inhalation powder 25 mcg, 100 mcg, and 200 mcg per blister strip will be administered using ELLIPTA for both treatment periods - DRUG : Fluticasone propionate (FP) Dry Powder Inhaler - Dry Inhalation powder 50 mcg, 100 mcg, 250 mcg, and 500 mcg per blister strip will be administered using DISKUS for both treatment periods - DRUG : Budesonide (BUD) Turbuhaler - Budesonide comprises white to off-white rounded granules, which disintegrate to a fine powder upon slight pressure, will be administered using Turbuhaler for both treatment periods. - DRUG : Placebo (ELLIPTA or DISKUS) - Lactose dry powder inhaler will be administered using ELLIPTA or DISKUS for both treatment periods.

#Eligibility Criteria: Inclusion Criteria - Subjects must be 18 <= age <= 65 of age inclusive, at the time of signing the informed Consent. - Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit - Pre-bronchodilator FEV1 >=65% of predicted at screening; the pre-dose baseline FEV1 should not have changed significantly in the opinion of the investigator from the screening baseline value and should be >=65% predicted for the subject to continue - Documented sensitivity to AMP with a provocative concentration of AMP resulting in a fall of >=20% FEV1 with a PC20 AMP <=80 mg/mL at the screening visit - Current therapy could include short-acting Beta2-agonists (SABA) prescribed SABA for at least 12 weeks prior to screening, if needed; subjects receiving low-dose ICS may take part after a 4-week ICS washout prior to AMP challenge. The subject's asthma symptoms must remain stable during this 4-week period as assessed at screening visit 2. Stable asthma is defined as no more than 2 consecutive days where >=12 inhalations/day of salbutamol were used; or no severe asthma exacerbations requiring use of systemic corticosteroids (tablets, suspension, or injection) or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids; or no clinical asthma worsening which in the opinion of the investigator requires additional asthma treatment other than study medication or salbutamol; subjects taking Long-acting beta2-agonist (LABA), long-acting muscarinic antagonist (LAMA), leukotriene receptor antagonist (LTRA) therapy within three months prior to the start of the study are not eligible; subjects taking biological therapies within 6 months prior to start of the study are not eligible. - Bodyweight >=50 Kilogram (kg) and BMI within the range 18.0 <= age <= 35.0 kg/meter (m)^2 (inclusive) - Male and female. Females: A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [HCG] test), not lactating, and at least one of the following conditions applies prior to randomization: * Non-reproductive potential defined as pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea, in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. * Reproductive potential and agrees to follow one of the highly effective methods for avoiding pregnancy in females of reproductive potential from 30 days prior to the first dose of study medication and until at least five terminal half-lives after the last dose of study medication. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. - Aspartate aminotransferase and Alanine transaminase <2x upper limit of normal (ULN); alkaline phosphatase and bilirubin <=1.5 x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) - Light smokers, who smoke <=20 cigarettes per week or equivalent unit dose of other tobacco products or e-cigarettes, are eligible for the study. Smokers who intend to stop, reduce or increase their smoking habit during the study period are not eligible. - Having provided written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: - A history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years. - Other significant pulmonary diseases to include (but not limited to) severe pneumonia within 6 months of the screening visit, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratory abnormalities other than asthma. - Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks of screening that: In the opinion of the investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study. - A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis at screening. - Any asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to randomization. - Use of prohibited medications including, anti-depressant drugs, and anti-asthma drugs (other than short acting inhaled beta-agonists supplied as rescue medication, oral contraceptives, non-steroidal anti-inflammatory drugs, stable doses of antihistamines, and paracetamol) for 1 week prior to screening and throughout the course of the study. Anti-histamines should be withheld 4 days prior to AMP challenge; subjects must also be able to abstain from short acting inhaled beta-agonists, for 8 hours prior to spirometry. - Subjects undergoing de-sensitization therapy - Current smokers who smoke > 20 cigarettes per week or the equivalent unit dose of other tobacco products or e-cigarettes, or smokers with a smoking history of >=10 pack years. - History of regular alcohol consumption exceeding 21 units per week for men and 14 units per week for females (1 unit =5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of spirits) within 6 months of screening. - All subjects who are currently or in the last month have worked night-shifts are excluded from the study - Exposure to more than four new chemical entities within 12 months prior to the first dosing day or received an investigational product within 30 days of study start, or 5 half-lives of study drug if that is longer. - A subject has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the study results if the condition/disease exacerbated during the study. (e.g. stroke or myocardial infarction within 3 months, uncontrolled hypertension, congestive heart failure, uncontrolled diabetes mellitus.) - Evidence of cancer or history of cancer in the past 5 years other than adequately treated basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix. - Pregnant females as determined by positive urine HCG test at screening or by positive urine HCG test prior to dosing and lactating females. - Subjects with active or chronic infections including hepatitis B or C, human immunodeficiency virus. A positive serology at screening. - Allergies: History of severe milk protein allergy Drug Allergy defined as any adverse reaction including immediate or delayed hypersensitivity to intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of FF, FP or BUD (i.e., lactose or magnesium stearate etc.) Historical Allergy defined as history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. - Significant abnormality in the 12-lead electrocardiogram (ECG) performed at screening. The mean of the three individual ECGs will be taken. Mean QT interval corrected for heart rate (QTc) >450 millisecond (msec) for males or QTc>470 msec for female subjects and >480 in subjects with bundle branch block. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF). 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

NCT02991859

{ "NCT_ID" : "NCT02594527", "Brief_Title" : "Southampton Mobility Volunteer Programme", "Official_title" : "The Southampton Mobility Volunteer Programme to Increase Physical Activity Levels of Older Inpatients: A Feasibility Study", "Conditions" : ["Physical Activity"], "Interventions" : ["Other: Volunteer-led physical activity session"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "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)" : "2017-10", "Study_Completion_Date(Actual)" : "2017-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-10-19", "First_Posted(Estimated)" : 2015-11-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-11-02", "Last_Update_Posted(Estimated)" : 2021-05-19", "Last_Verified" : 2021-05" } }}

#Study Description Brief Summary Physical activity levels of hospitalised older inpatients is low and this results in many adverse health outcomes. Studies have shown that interventions designed to promote increased physical activity of older inpatients using paid staff have shown improvement in physical function of older inpatients, resulting in shorter hospital stay and reduced admissions to nursing home. This study aims to assess the feasibility and acceptability of using trained volunteers to increase physical activity of older people in hospital. Volunteers will be recruited and trained to encourage older inpatients to mobilise or perform chair-based exercises. Patients will be encouraged to walk or exercise with the volunteers twice a day during their hospital stay. Quantitative analysis will be conducted on the outcome measures. Patients, volunteers and staff members will also be interviewed to assess the acceptability of the intervention. This feasibility study will help inform a future controlled trial. Detailed Description Background: Previous research has shown that low mobility among older people in hospital is associated with poor health outcomes including worsening physical function and increasing dependence in activities of daily living. There is evidence that the implementation by hospital staff of a mobility or exercise programme for older people in the acute care setting is feasible with promising outcomes including improvement in physical function, shorter hospital stay and reduced nursing home admissions. However employing additional therapy or nursing staff is costly and there are well-recognised shortages of suitable applicants to recruit to these posts. Many National Health Service trusts have an established volunteer workforce and in Southampton trained volunteers have successfully assisted older inpatients at mealtimes. Objective: This study aims to assess the feasibility and acceptability of using trained volunteers to increase physical activity levels of older people in hospital. Methods and design: The first part of this feasibility study is the development with the therapy team of a training programme, based on existing literature and best practice, to ensure competency of volunteers in mobilising patients and encouraging physical exercise. The study will be conducted on 2 wards (1 male 1 female) within the Medicine for Older People department. Eligible patients will be encouraged by volunteers to mobilise or perform chair-based exercises, depending on their mobility status, at least twice a day for about 15 minutes each session. The recruitment and retention rates of volunteers will be analysed as will the physical activity interventions they were able to effect. The recruitment of patients, their physical activity and adherence to the intervention will be studied. Qualitative interviews and focus groups will be conducted to explore the views and experiences of the patients, volunteers and health care professionals involved in this study. Participants will be characterised including the measurement of physical activity levels using a StepWatch Activity Monitor and GENEActiv accelerometer. This feasibility study is not powered to show a statistical difference in the outcome measures but data from this study will determine the sample size for future controlled trials. Discussion: Results from this study will provide valuable information regarding the use of trained volunteers to promote physical activity among older inpatients and the practicalities of implementing the intervention throughout the whole department. #Intervention - OTHER : Volunteer-led physical activity session - Participants will be encouraged by volunteers to walk or perform chair-based exercises during their stay in hospital

#Eligibility Criteria: Inclusion Criteria: * deemed appropriate by the medical team and therapists to receive a physical activity intervention by trained volunteers and able to mobilise with or without a walking aid. Exclusion Criteria: * patients normally resident in a nursing home, or who were immobile prior to admission; * patients who are in a side room for infection control reasons; * palliative care patients; * patients deemed inappropriate for the physical activity intervention by the medical or therapy teams. Sex : ALL Ages : - Minimum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: No

NCT02594527

{ "NCT_ID" : "NCT05845294", "Brief_Title" : "A Study of the Effect of Short-term Structured Psychological Care in Patients", "Official_title" : "A Study of the Effect of Short-term Structured Psychological Care on the Level of Postoperative Stigma in Patients With Colorectal Cancer", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Procedure: Short-term structured psychological Care", "Procedure: Routine Care"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-08-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-01", "Study_Completion_Date(Actual)" : "2020-12-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-04-13", "First_Posted(Estimated)" : 2023-05-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-04-25", "Last_Update_Posted(Estimated)" : 2023-05-06", "Last_Verified" : 2023-04" } }}

#Study Description Brief Summary The study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy. #Intervention - PROCEDURE : Routine Care - Routine care for patients undergoing colorectal cancer stoma - PROCEDURE : Short-term structured psychological Care - Short-term structured psychological care for colorectal cancer stoma patients based on conventional care

#Eligibility Criteria: Inclusion Criteria: * voluntary participation in the study and ability to cooperate with treatment and care; * patients who were to undergo enterostomy; * age >=18 years; * consciousness (being able to complete the questionnaire alone or able to answer the questions correctly); * social impact scale (SIS) score >=24. Exclusion Criteria: * Critically ill and unable to cooperate with the study; * Impaired cognitive function that affects communication; * Patients with other organic diseases in combination. 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

NCT05845294

{ "NCT_ID" : "NCT01564667", "Brief_Title" : "Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)", "Official_title" : "Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study", "Conditions" : ["Posttraumatic Stress Disorder"], "Interventions" : ["Behavioral: Attention Bias Modification Training Protocol"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-12", "Study_Completion_Date(Actual)" : "2014-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-03-26", "First_Posted(Estimated)" : 2012-03-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-03-27", "Last_Update_Posted(Estimated)" : 2016-01-14", "Last_Verified" : 2016-01" } }}

#Study Description Brief Summary Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. Participants will also be invited to participate in physiological testing before and after receiving AMBT or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension. The investigators expect to see significant PTSD symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we will offer active ABMT to those participants randomly assigned to the placebo arm if they would like to receive the treatment. #Intervention - BEHAVIORAL : Attention Bias Modification Training Protocol - Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.

#Eligibility Criteria: Inclusion Criteria: * Veterans with Posttraumatic Stress Disorder (PTSD) serving in United States Military after March 20, 2003. Exclusion Criteria: * Schizophrenia * Bipolar Disorder * Obsessive Compulsive Disorder * Head Injury with Loss of Consciousness for more than 30 minutes * Active Alcohol/Substance Dependence in past 6 months Sex : ALL Ages : - Minimum Age : 19 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01564667

{ "NCT_ID" : "NCT01578967", "Brief_Title" : "Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma", "Official_title" : "LCCC 1115: A Pilot Feasibility Trial of Induction Chemotherapy With ABVD Followed by Brentuximab Vedotin (SGN-35) Consolidation in Patients With Previously Untreated Non-Bulky Stage I or II Hodgkin Lymphoma (HL)", "Conditions" : ["Hodgkin Lymphoma, Adult"], "Interventions" : ["Drug: Brentuximab vedotin", "Drug: ABVD"], "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)" : "2012-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-08-10", "Study_Completion_Date(Actual)" : "2020-12-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-04-13", "First_Submitted_that_Met_QC_Criteria" : 2017-09-11", "First_Posted(Estimated)" : 2012-04-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-04-13", "Last_Update_Posted(Estimated)" : 2021-12-07", "Last_Verified" : 2021-11" } }}

#Study Description Brief Summary The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4 chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive radiation therapy. The use of chemotherapy and radiation may cause long term treatment related side effects such as heart problems and other cancers. Researchers are trying to find if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy cycles given is just as effective as the standard Hodgkin treatment. Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational. Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it. Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target called cluster of differentiation antigen 30 (CD30). CD30 is an important molecule on some cancer cells and some normal cells of the immune system. The purpose of this research study is to see the effects of treatment with fewer cycles of the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on study participants and Hodgkins lymphoma. Detailed Description This study is designed as a single arm pilot feasibility trial using an induction of 2-6 cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) chemotherapy followed by 6 cycles of brentuximab vedotin (SGN-35) consolidation for previously untreated patients with stage I and II non-bulky Hodgkin Lymphoma (HL). Feasibility will be determined by the percentage of patients who have no clinical evidence of HL, and achieve positron emission tomograph (PET) negative disease post brentuximab consolidation. We anticipate approximately 40 patients will be eligible across participating centers (including UNC, Mayo Clinic, and the UNC Cancer Network (UNCCN)) over a 2 year period. A future phase II study evaluating progression free survival (PFS) after ABVD followed by brentuximab vedotin will be considered feasible if ≥ 13 of 15 patients enrolled in this pilot trial become PET negative after brentuximab vedotin consolidation. #Intervention - DRUG : Brentuximab vedotin - IV, 1.8mg/kg, every 3 weeks for 6 cycles. - Other Names : - SGN-35, Adcetris - DRUG : ABVD - Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles. Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles. Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.

#Eligibility Criteria: Inclusion Criteria: * Previously untreated stage I or II non-bulky Hodgkin lymphoma * No mediastinal mass >0.33 maximum intrathoracic diameter on chest x-ray (see Appendix B) * No adenopathy >=7.5 cm in its largest diameter * Measurable disease as assessed by 2 dimensional measurement by CT (>2cm or 1.5 cm if 0.5 cm slices are used, as in spiral CT scan) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 2 * Age >=18 years and <=60 years * Life expectancy of at least 3 months * Adequate bone marrow function (without transfusion support within one week of screening) as demonstrated by: * Hemoglobin >= 8 g/dL * Absolute neutrophil count (ANC) >= 1,000 cells/mm3 * Platelet count >= 75,000/mm3 * Adequate hepatic and renal function as demonstrated by: * Aspartate aminotransferase (AST) <= 2.5 x upper limit of normal (ULN) * Total serum bilirubin <=1.5 x ULN * Serum creatinine <= 2.0 mg/dL * Negative serum human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours of day 1 of treatment with ABVD in women of child-bearing potential * Females of childbearing potential, and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of brentuximab vedotin. Effective contraception is defined as any medically recommended method (or combination of methods) as per standard of care, including abstinence. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. * Signed an institutional review board (IRB)-approved informed consent document for this protocol Prior to Day 1 of brentuximab vedotin, patients must again meet the following inclusion criteria: * Adequate bone marrow function (without transfusion support within one week of D1 of brentuximab vedotin) as demonstrated by: * Hemoglobin >= 8 g/dL * Absolute neutrophil count (ANC) >= 1,000 cells/mm3 * Platelet count >= 75,000/mm3 * Adequate hepatic and renal function as demonstrated by: * Aspartate aminotransferase (AST) <= 2.5 x upper limit of normal (ULN) * Total serum bilirubin <=1.5 x ULN * Serum creatinine <= 2.0 mg/dL * Achieved at least a partial response (PR) (and not progressed) after ABVD therapy Exclusion Criteria: * Prior therapies for treatment of HL including involved field radiation therapy or any prior treatment for any malignancy with anthracyclines. * Bulky disease (defined as a mass measuring > 7.5 cm or one-third the maximal diameter of the thoracic cavity) * Known central nervous system (CNS) involvement * Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators * Known history of human immunodeficiency virus (HIV), hepatitis B and hepatitis C (testing is not necessary if patient does not have history of these diseases, and no risk factors for acquisition of these viruses) * Cardiac disease with left ventricular ejection fraction of less than 45% * Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD * Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective * Other active malignancies with the exception of: * Non-melanoma skin cancer * Cervical carcinoma in situ without evidence of disease * Prostatic intraepithelial neoplasia without evidence of prostate cancer * Pregnant or lactating women Prior to Day 1 of brentuximab vedotin, please verify the patient does not meet the criteria below: * Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT01578967

{ "NCT_ID" : "NCT00753454", "Brief_Title" : "Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)", "Official_title" : "A Phase IIIb, Multi-center Open-label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077.", "Conditions" : ["Rheumatoid Arthritis"], "Interventions" : ["Drug: Certolizumab pegol"], "Location_Countries" : ["Canada", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2008-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-05", "Study_Completion_Date(Actual)" : "2011-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-06-05", "First_Submitted_that_Met_QC_Criteria" : 2012-05-10", "First_Posted(Estimated)" : 2008-09-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-09-15", "Last_Update_Posted(Estimated)" : 2018-08-01", "Last_Verified" : 2012-07" } }}

#Study Description Brief Summary The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX). Detailed Description Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defined as patients that have randomized at Week 18 and experienced at 2 consecutive visits between Week 18 and Week 34 inclusive an equal to Baseline (W0) or worst swollen and tender joints counts), will be given the option to enroll in C87084 and receive certolizumab pegol \[400 mg at Entry, Week 2, and Week 4 followed by 200 mg every two weeks (Q2W)\] in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region or until further notice from UCB. All patients will continue their MTX treatment at the same stable dose as during the C87077 (NCT00580840) study, unless there is a need to reduce the dose for reasons for toxicity. #Intervention - DRUG : Certolizumab pegol - Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 \& Week 4, followed by 200 mg every 2 weeks). - Other Names : - Cimzia

#Eligibility Criteria: Inclusion Criteria: * Patients must be able to understand the written Informed Consent Form (ICF) * Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare * Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840) * Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation * Patients must be willing to comply with protocol Exclusion Criteria: * Patients must not have a diagnosis of any other inflammatory Arthritis * Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA) * Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ * Patients who do not meet the Medical History Exclusion criteria, as defined per protocol. Examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active Tuberculosis (TB), high risk of infection, Lymphproliferative Disorder, acute or chronic Viral Hepatitis B or C, known Human Immunodeficiency Virus (HIV), Malignancy or history of Malignancy, history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease 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

NCT00753454

{ "NCT_ID" : "NCT03719794", "Brief_Title" : "Probiotics for Vascular Inflammation in Metabolic Syndrome", "Official_title" : "Probiotics for Vascular Inflammation in Metabolic Syndrome (PROMISE): a 12-Week Pilot Study, Randomized,Double-Blinded, Placebo-Controlled Trial", "Conditions" : ["Metabolic Syndrome"], "Interventions" : ["Dietary Supplement: Probiotic supplement", "Dietary Supplement: Placebo supplement"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-04-16", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-01", "Study_Completion_Date(Actual)" : "2020-10-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-09-12", "First_Posted(Estimated)" : 2018-10-25" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-10-23", "Last_Update_Posted(Estimated)" : 2021-01-14", "Last_Verified" : 2021-01" } }}

#Study Description Brief Summary Subjects with metabolic syndrome are known to possess chronic low-level inflammation. Furthermore, such individuals are at risk of developing atherosclerosis in coronary and other vascular beds. In particular, subjects with metabolic syndrome, prediabetes and type II diabetes mellitus were shown to possess vascular inflammation in carotid atherosclerosis as demonstrated using FDG-PET. In the current pilot proposal, the investigators wish to study the impact of 3-month probiotic supplementation on vascular and systemic inflammation in subjects with metabolic syndrome in the context of a randomized, placebo-controlled, pilot trial. #Intervention - DIETARY_SUPPLEMENT : Probiotic supplement - Probiotic supplement once daily (xyz) for 12 weeks - DIETARY_SUPPLEMENT : Placebo supplement - Placebo supplement once daily for 12 weeks

#Eligibility Criteria: Inclusion Criteria: * Male and female > 50 yearsyears * Presence of MetS as defined according to recent updated criteria (13): Presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off) depending on the recently published ethnic-based variations (14), triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l. * Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits. * Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements). * Able to provide informed consent. Exclusion Criteria: * Concurrent consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements). Subjects will be eligible for participation, however, after a two-week washout period * Overt or documented vascular disease (coronary heart disease, cerebrovascular disease, or peripheral vascular disease). * Participants suffering from dementia (mini mental state examination) or depression (geriatric depression scale). * Concurrent statin therapy. (Statins have been shown to reduce vascular inflammation as measured by FDG-PET-see section 9.1). * Color blind * Concurrent antibiotic therapy. However, screened participants would be eligible to participate two weeks after completing their course of antibiotics (wash-out period). * Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months. * Women of childbearing potential not using effective contraception. Acceptable methods of birth control includes: * Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants; * Intrauterine devices (IUD) or Intrauterine system (IUS); * Tubal ligation; * Vasectomy of partner; * Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap). * Positive pregnancy test in women of childbearing potential. * Allergy to milk, soy, or yeast. * Use of another investigational product within 3 months of the screening visit. * Claustrophobia * Patient with pacemaker * Patient with BMI greater than 40 kg/m2 * Immune disorder. * Drug and alcohol abuse * Current use of NSAIDs * Liver and kidney disorders * Bleeding/blood disorder Sex : ALL Ages : - Minimum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03719794

{ "NCT_ID" : "NCT03006497", "Brief_Title" : "Exercise Program Based on Motor Learning and Forward Head Posture Correction", "Official_title" : "The Efficacy of Exercise Program Based on Motor Learning Principles in Correction of Forward Head Posture", "Conditions" : ["Musculoskeletal Abnormalities", "Deformity"], "Interventions" : ["Other: Exercise program based on motor learning principles"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-05", "Study_Completion_Date(Actual)" : "2017-12-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-12-03", "First_Posted(Estimated)" : 2016-12-30" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-12-29", "Last_Update_Posted(Estimated)" : 2019-01-09", "Last_Verified" : 2019-01" } }}

#Study Description Brief Summary The aim of this study is to investigate the efficiency of an exercise program based on principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic patients. Detailed Description Epidemiological studies have shown that bad posture and poor body control occurs at puberty, with forward head posture (FHP) and rounded shoulders being the most common biomechanical deviations in sagittal plane. The FHP is defined as an anterior displacement of the head with hyperextension of the cervical spine and this is associated with a reduction in the length of the upper portion of the trapezius, posterior portion of the cervical extensor muscles, the sternocleidomastoid and the levator scapulae. FHP can be evaluated by measuring craniovertebral angle (CVA) which is defined as the angle between a horizontal line passing through C7 and a line extending from the tragus of the ear to C7. CVA, smaller than 50 degrees, constitute a criterion of abnormal posture of cervical spine, suggesting FHP. People with FHP present incomplete balance control, thereby affecting the position of the center of gravity and motor control of the body. The establishment of altered motor control strategies could lead to balance disorders, neck muscle imbalances, chronic neck pain and even respiratory dysfunction. Despite the efforts of researchers to create effective treatment programs based on strength training and stretching exercises, positive long-term results have been a problem in FHP correction. For this reason, re-education of posture and body alignment, through exercise programs based on motor learning, with cognitive elements (attention, motivation, feedback, reasoning), could be proved a more effective therapeutic strategy. #Intervention - OTHER : Exercise program based on motor learning principles - The exercise program will include simple activities exposing volunteers in various environmental conditions with a view to adjust their head posture in such conditions. The progressiveness of exercises will be based on the two-dimensional classification system of Gentile (1987). Furthermore, external attentional focus will be used.

#Eligibility Criteria: Inclusion Criteria: * Students at Technological Educational Institute of Sterea Ellada, * Aged 18 <= age <= 26 years * Males and females * Craniocervical angle < 50 degrees (statical Forward Head Posture in standing position) Exclusion Criteria: * Injury or surgery in cervical spine * Accompanying neurologic, musculoskeletal or mental problems * Any medical administration * Intense continuous or intermittent neck pain * BMI >25 * Participation in any rehabilitation or physiotherapy sessions considering neck dysfunction the last 6 months * Change in physical activities during the research period of 6 weeks Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 26 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT03006497

{ "NCT_ID" : "NCT02114905", "Brief_Title" : "Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study", "Official_title" : "Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study", "Conditions" : ["Tourette Disorder", "Chronic Tic Disorder"], "Interventions" : ["Behavioral: OTs Trained and Deliver CBIT"], "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)" : "2013-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-08", "Study_Completion_Date(Actual)" : "2015-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-02-06", "First_Posted(Estimated)" : 2014-04-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-04-10", "Last_Update_Posted(Estimated)" : 2019-09-20", "Last_Verified" : 2019-09" } }}

#Study Description Brief Summary Comprehensive Behavioral Intervention for Tics (CBIT) is an evidence based intervention for tic disorders. A recent scientific review of research priorities completed by the Tourette Syndrome Association recommended widespread dissemination of CBIT as an important next step in services delivery research. Given early evidence that occupational therapists can deliver CBIT effectively, a dissemination strategy using occupational therapists may improve accessibility to this treatment, at lower cost and with decreased stigma. Thus the goal of this study is to develop and test a training and dissemination model with occupational therapists (OTs) using an expert, multi-disciplinary team at Weill Cornell/New York Presbyterian Hospital (WC/NYPH) and University of Alabama at Birmingham (UAB). The investigators have adapted CBIT, the gold-standard behavioral intervention program for children with tic disorders (Woods et al, 2008a,b), for eventual use in OT programs across the country. Detailed Description CBIT training materials designed by the study team have been used to train occupational therapists (OTs) at WC/NYPH and UAB to deliver CBIT, and data has been collected to measure training acceptability. OTs will be supervised in the practice of CBIT with youth in the New York City and Birmingham areas. Pre- and post-treatment assessment measures will be collected from 16 families (8 from each site) to evaluate intervention acceptability, feasibility, and fidelity. Patient and parent satisfaction of CBIT-OT will also be documented. The investigators will look within subjects to ascertain change in reported tic severity. This study is designed to determine the feasibility and acceptability of treatment, feasibility of research design, as well as demonstrate the ability to disseminate the study protocol to a new care discipline in methodologically rigorous fashion across multiple sites. #Intervention - BEHAVIORAL : OTs Trained and Deliver CBIT - CBIT is a highly structured therapy that typically takes place on a weekly basis. The patient is taught to perform a specific behavior that makes the tic more difficult to do, as soon as the tic or urge appears. This 'competing response' helps to reduce, and in some cases, even eliminate the tic. The functional intervention (FI), is based on the fact that certain situations or reactions to tics can make them worse than they might otherwise be. The goal of FI is to identify these situations and have the patient and family attempt to change them so the tics aren't made worse unnecessarily. - Other Names : - CBIT

#Eligibility Criteria: Inclusion Criteria: * Age 7 <= age <= 17 * Presence of motor and/or vocal tics for at least 6 months * Tics are of at least moderate clinical severity as evidenced by a Clinical Global Impressions Severity (CGI-S) score of 4 or higher (tic symptoms clearly noticeable to family and occasionally to families and associated with at least some minimal level of distress and/or interference. * IQ estimate of 70 or higher * Comorbid disorder (e.g., ADHD, OCD,ODD) will be allowed provided that the tic symptoms are of primary concern to parents and comorbid symptoms are not of sufficient severity to require immediate treatment other than that provided by the current study. * Pre-existing stable medication, tic or otherwise, will also be allowed provided the family agrees to refrain from med changes over the course of the study if at all possible. * Sufficient command of the English language to comply with study protocol. Exclusion Criteria: * Free of PDD or other developmental disability Sex : ALL Ages : - Minimum Age : 7 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT02114905

{ "NCT_ID" : "NCT02602522", "Brief_Title" : "Danshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary Dysmenorrhea", "Official_title" : "The Comparison of the Effect on Danshen-Jiang-Fu Granule Prepared by Danshen (Salvia Miltiorrhiza) From Different Producing Areas (Shandong and Sichuan) for Primary Dysmenorrhea: a Cross-over, Randomized, Double-blind Controlled Trials", "Conditions" : ["Primary Dysmenorrhea", "Traditional Chinese Medicine"], "Interventions" : ["Drug: Sichuan Danshen-Jiang-Fu Granule", "Drug: Shandong Danshen-Jiang-Fu Granule"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-07", "Study_Completion_Date(Actual)" : "2018-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-11-07", "First_Posted(Estimated)" : 2015-11-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-11-10", "Last_Update_Posted(Estimated)" : 2019-02-05", "Last_Verified" : 2019-02" } }}

#Study Description Brief Summary This trial aims to compare the effect of Danshen-Jiang-Fu Granule prepared by Danshen (Salvia Miltiorrhiza) from different producing areas (Shandong and Sichuan) for the relief of primary dysmenorrhea. #Intervention - DRUG : Shandong Danshen-Jiang-Fu Granule - Danshen-Jiang-Fu Granule is prepared from 4 kinds of Chinese herbs including Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi), Wuyao(Lindera Aggregata). The producing area of Danshen in Shandong Danshen-Jiang-Fu Granule is Laiwu District in Shandong province. - DRUG : Sichuan Danshen-Jiang-Fu Granule - Danshen-Jiang-Fu Granule is prepared from 4 kinds of Chinese herbs including Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi), Wuyao(Lindera Aggregata). The producing area of Danshen in Sichuan Danshen-Jiang-Fu Granule is Zhongjiang District in Sichuan province.

#Eligibility Criteria: Inclusion Criteria: * meeting the diagnostic criteria of primary dysmenorrhea in the Primary Dysmenorrhea Consensus Guideline; * meeting the diagnostic criteria of Hanning-xueyu(blood stasis due to cold accumulation) Zheng according to Gynecology of Chinese medicine; * with regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 9 days in the last 6 months; * course of dysmenorrhea over 6 months; * experienced menstrual pain scoring varying from 3cm to 6cm on a 10-cm VAS during the baseline menstrual period (one period prior to present menstrual period with treatment); * without history of pregnancy; * with agreement of informed consent and a working phone. Exclusion Criteria: * history of abdominal surgery; * with other acute or chronic painful conditions diagnosed or suspected; * use of hormonal contraceptives, or intra-uterine device; * use of analgetic drugs or other analgetic treatment in the last 2 weeks; * known allergy to Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi) or Wuyao(Lindera Aggregata); * prone to allergy in daily life; * who can not complete treatment adherence to the protocol; * attending in other trials in the last 3 months. Sex : FEMALE Ages : - Minimum Age : 14 Years - Maximum Age : 25 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT02602522

{ "NCT_ID" : "NCT03561974", "Brief_Title" : "Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation", "Official_title" : "Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation", "Conditions" : ["Chronic Respiratory Failure With Hypercapnia"], "Interventions" : ["Device: Humidification"], "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)" : "2018-05-21", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03-14", "Study_Completion_Date(Actual)" : "2019-03-14}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-05-18", "First_Posted(Estimated)" : 2018-06-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-06-18", "Last_Update_Posted(Estimated)" : 2019-03-15", "Last_Verified" : 2019-03" } }}

#Study Description Brief Summary Protocol Summary: 1. Question Does the adjunction of a humidification system to non-invasive ventilation circuit improve sleep quality and comfort of chronic ventilated respiratory insufficient patients? Does it change the efficacy of long-term non invasive ventilation therapy and patient-ventilator interactions? 2. Aims Main aim: The primary endpoint of this study is to objectively evaluate the consequences of a humidification system's adjunction on quality of sleep, 2 months after treatment's beginning. Second aims: The secondary endpoints are to evaluate the consequences of a humidification system's adjunction on non invasive ventilation's efficacy / patient-ventilator asynchronies / patients' comfort / treatment adherence. Before the clinical trial, the investigators conducted a bench study using a mechanical lung in order to evaluate the ventilator's behavior with and without a humidification system. The clinical trial will include patients with chronic respiratory failure with an indication of long-term non invasive ventilation therapy. Patients will be included in the Pulmonology, Thoracic Oncology and Respiratory intensive care unit of Rouen University Hospital. It will be a prospective monocentric study, including consecutively all eligible patients. Informed consent will be obtained from all of them. At baseline, patients will be hospitalized for two consecutive nights for non invasive ventilation's set up. During the first night, a polysomnography will be performed without non invasive ventilation. Then, patients will be treated by non invasive ventilation with a bi-level self-regulated pressure mode and an open circuit. Patients will be randomized in two groups: without a humidification system and with a humidification system. Partitioning by the physiopathological pattern (obstructive versus obesity hypoventilation syndrome vs. neuromuscular disease) will be done. During each night, arterial blood gases will be measured at bedtime and awakening. Patients will be monitored by: * polysomnography (only during the first night) * transcutaneous capnography * accessory inspiratory muscles surface electromyography * pneumotachograph on non invasive ventilation's circuit * pressions measured at the mask. Follow-up will take place at two months after non invasive ventilation's beginning with or without humidification. Patients will be hospitalized for one night only. Blood gases at bedtime and at awakening will be measured. A polysomnography with non invasive ventilation will be performed. Observance will be evaluated. #Intervention - DEVICE : Humidification - Patients will benefit of humidification and warming of delivered gaz by non-invasive ventilation thanks humidification system.

#Eligibility Criteria: Inclusion Criteria: * Type 2 chronic respiratory failure (PaCO2 > 6,5 at the time of the diagnosis) * Indication of a long term non invasive ventilation at home because of an obstructive respiratory disease, a obesity hypoventilation syndrome or a neuromuscular disease. * Over eighteen years old * Planned hospitalisation to introduce non invasive ventilation. Exclusion Criteria: * Less than eighteen years old * Pregnancy * Psychiatric or cognitive disorders in wich consent is not possible * Acute respiratory failure within 2 weeks before inclusion. 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

NCT03561974

{ "NCT_ID" : "NCT02491723", "Brief_Title" : "Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa", "Official_title" : "Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa Via NLRC4 Inflammasome Signaling Pathway", "Conditions" : ["Bronchiectasis"], "Interventions" : ["Drug: Azithromycin"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-01", "Study_Completion_Date(Actual)" : "2016-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-07-03", "First_Posted(Estimated)" : 2015-07-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-07-03", "Last_Update_Posted(Estimated)" : 2016-10-14", "Last_Verified" : 2016-10" } }}

#Study Description Brief Summary It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence against viral and bacterial stimuli by modulating the immune response. The aim of this study was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate whether macrolide attenuate its levels. Detailed Description Non-cystic fibrosis bronchiectasis is a respiratory disease characterized by persistent airway inflammation and dilation of bronchial wall driven by various causes. Patients with bronchiectasis suffer from excessive sputum production, recurrent exacerbations, and progressive airway destruction. It was reported that 30%-40% patients were infected with Pseudomonas aeruginosa. Major therapy for bronchiectasis is focused on breaking the 'vicious cycle' of mucus stasis, infection, inflammation, and airway destruction. Currently a number of clinical trials have showed that macrolide effectively used in the treatment of non-CF bronchiectasis. Evidence has indicated that 14- and 15-membered ring macrolides possess immunomodulation and anti-inflammatory functions beyond their antimicrobial properties. However, the underlying mechanisms that account for the anti-inflammatory actions of macrolides have not yet to be elucidated, and the activities do not appear to be controlled by a single mechanism.Interleukin-18 (IL-18), along with interleukin-1b (IL-1b), is produced by inflammasomes when activated by a number of pathogen, environmental or host-derived danger signals. Inflammasomes are innate immune regulatory protein complexes which seem to play a key role in the host immune response of patients with Bronchiectasis. The aim of this study was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate whether macrolide could attenuate its levels. #Intervention - DRUG : Azithromycin - Patients with bronchiectasis treated with Azithromycin for three to five days. - Other Names : - macrolide

#Eligibility Criteria: Inclusion Criteria: * Able to provide written informed consent. * Confirmed diagnosis of bronchiectasis by HRCT. * Aged 18 <= age <= 85 years. Exclusion Criteria: * Bronchiectasis as a result of CF or active tuberculosis or non-tuberculous mycobacterial (NTM) infection. * Allergy to macrolide antibiotics * Any history of severe cardiopulmonary dysfunction, eg. left heart failure, Unstable cardiac arrhythmias * pregnant or nursing * hypogammaglobulinemia or other autoimmune disease 6. diagnosed with ABPA 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: Yes

NCT02491723

{ "NCT_ID" : "NCT00858442", "Brief_Title" : "Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities", "Official_title" : "PRP on Children With Retractable Burn Sequelae Who Have Submitted Release of Burn Contractures and Skin Graft on Their Limbs. A Double-Blind Randomized Clinical Trial", "Conditions" : ["Burns"], "Interventions" : ["Procedure: With PRP"], "Location_Countries" : ["Chile"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-10", "Study_Completion_Date(Actual)" : "2012-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-03-05", "First_Submitted_that_Met_QC_Criteria" : 2015-01-22", "First_Posted(Estimated)" : 2009-03-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-03-05", "Last_Update_Posted(Estimated)" : 2015-02-13", "Last_Verified" : 2015-01" } }}

#Study Description Brief Summary Does the addition of Platelet-Rich Plasma (PRP) to release of burn contractures and skin graft on the limbs of children with retractable burn sequelae reduce the initial time of the compressive treatment and maintain or lower the graft's retraction? Detailed Description Hypothesis: 1. The use of PRP will allow to initiate sooner the compressive treatment during the post graft surgery evolution, in fewer days on average than the traditional method (18 ds). 2. The use of PRP will maintain the same initial size of the graft. The study's domain corresponds to burn sequelae on children in treatment with reconstructive surgery due to retractile sequelae located on their upper and lower limbs, with functional compromise during their growth process. One of the treatments used for this problem is the surgical technique of with release of burn contractures and skin graft. Split skin grafts are at risk of suboptimal 'take' due to bleeding and infection which would, on the one hand, delay the initiation of the rehabilitation with preventive compression to avoid the retraction of the grafted area. 20% of the children that arrive in COANIQUEM (approximately 7,000 annually), require rehabilitation. Of these, 32% have surgery and 9% of those are release of burn contractures and skin graft mainly on extremities. #Intervention - PROCEDURE : With PRP - Release of burn contractures and skin graft on the affected limb, a rigorous haemostasis. The surgeon must distribute the activated PRP evenly, forming a very fine clot over it. Immediately the split skin graft must be applied, duly fenestrated. The grafted zone will be measured in it's longest width and length, taking a standardized photograph. On the 5th day the nurse will evaluate the graft's conditions. The evaluation will be done following a previously established follow-up protocol. Measurements of width \& length of graft and standardized photo taken at the initiation of the compressive system. Measurement of graft's width \& length and standardized photo at the end of the compressive system according protocol. Statistical analysis.

#Eligibility Criteria: Inclusion Criteria: * Patients with burn sequelae on their upper or lower limbs * Treated with release of burn contractures and skin graft on their upper or lower limbs * Between 5 and 21 years * Following instructions in their homes * With informed and written consent * Weight 35 Kg or more * Blood count * Hepatic and coagulation tests * Paediatric evaluation prior to surgery Exclusion Criteria: * Background of blood alterations * Another current pathology Sex : ALL Ages : - Minimum Age : 5 Years - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT00858442

{ "NCT_ID" : "NCT02193230", "Brief_Title" : "Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence", "Official_title" : "Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence.", "Conditions" : ["Atopic Dermatitis"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-10-14", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-09-30", "Study_Completion_Date(Actual)" : "2015-10-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-07-15", "First_Posted(Estimated)" : 2014-07-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-07-16", "Last_Update_Posted(Estimated)" : 2021-09-16", "Last_Verified" : 2021-09" } }}

#Study Description Brief Summary Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood. The treatment consists in making daily local treatment with topical steroid on inflammatory lesions and emollient on the whole body. However, approximately 70% of patients do not adhere to therapy. Studies have shown that this treatment failure is caused by the complexity of the treatment, the time required for its implementation, the cost of treatment, the dosage of the products, fear of side effects or misunderstanding about the chronicity of these diseases inflammatory conditions of the skin. This study aims to evaluate the consideration of patient preference in the choice of excipient used for the topical treatment of eczema. Detailed Description Day 0 : * Inclusion, collecting non-opposition * Presentation of the samples: 4 products presented in the same packaging (pump bottle 200 ml) and ranked in order of their fat content: * Cold Cream: 88% * Modified Cerat Galen (national formulary): 66% * Cold Cream Fluid: 32% * Ointment: 21% The 4 products are all equally effective and suited in the treatment of atopic dermatitis. The patient choose the cream it will apply from 4 presented. A total of two bottles will be given to the patient. A bottle containing only the emollient applied to dry areas and another bottle in which 30% will be added Diprosone (topical steroid) to be applied on areas of eczema). * Remitting the questionnaires * Severity scoring of atopic dermatitis (SCORAD) Day 30: * Remitting the questionnaires * Treatments delivery for 2 months * SCORAD / PO SCORAD * Treatment weighing Day 90: * SCORAD / PO-SCORAD * Treatments weighing * Remitting the final questionnaire

#Eligibility Criteria: Inclusion Criteria: Patients experiencing treatment failure despite appropriate treatment. Patients minors aged between 3 and 15 years For children age 7 and non-autonomous children in the application of treatment, the parent at the initial consultation should be the one who treats the child. Information from both parents or parental authority and collection of Non-Opposition The patient must have a computer to do its PO-SCORAD between consultations. Patient who used a topical treatment for atopic dermatitis in the week preceding the study. Exclusion Criteria: Patient refusal to participate in the clinical study. Adults and children > 15 years. Sex : ALL Ages : - Minimum Age : 3 Years - Maximum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT02193230

{ "NCT_ID" : "NCT01326637", "Brief_Title" : "Human Factors Intervention to Reduce Risk in Primary Care of the Elderly", "Official_title" : "A Human Factors Intervention to Reduce Risk in Primary Care of the Elderly", "Conditions" : ["Primary Health Care", "Aged", "Clinical Information"], "Interventions" : ["Other: Patient Overview Document"], "Location_Countries" : ["United States"], "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)" : "2013-01", "Study_Completion_Date(Actual)" : "2017-12-21}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-03-23", "First_Posted(Estimated)" : 2011-03-31" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-03-29", "Last_Update_Posted(Estimated)" : 2019-02-12", "Last_Verified" : 2019-02" } }}

#Study Description Brief Summary Human factors engineering literature makes clear that appropriate, well-designed and well-timed information improves decision making and can reduce mental workload. Data from a previous study showed that appropriate, well-designed and well-timed information is not present in many primary care encounters with elderly patients. This puts primary care physicians at risk of higher mental workload and poor decision making which can affect the quality and safety of care delivered to patients. Elderly patients are at particular risk because they are more likely to have more comorbidities, medications, and cognitive impairments. Dr. Karsh and his research team will test an intervention to improve the performance of primary care physicians and, thus the safety of primary care of the elderly. The investigators will use a randomized experiment, with random assignment at the level of patient, to test and evaluate the intervention. The evaluation will involve 4 primary care clinics, with 4 primary care physicians per clinic. The investigators will collect data from 768 patient visits pre-intervention and 1536 patient visits during the intervention. Intervention patients will be randomly assigned to the intervention or care as usual. The Intervention has two components: Pre-visit care coordination: * 5-7 days prior to a study patient's appointment with his/her doctor, the doctor's nurse/MA will call the study patient and collect pertinent clinical information about the patient using a data collection form the investigators call a Patient Overview Document or POD. * The nurse/MA will ensure that any lab results, consultant reports, ER reports, imaging studies, etc., that will be needed by the physician are available to the doctor. Team Meeting: On the day of the patient's appointment and prior to the beginning of the clinic session, the nurse/MA will meet briefly with the doctor to jointly review the POD. Hypotheses: H1. Primary Care Physician (PCP): The intervention will increase situation awareness, reduce PCP mental workload, reduce PCP perceived likelihood of error, and improve PCP visit satisfaction. PCP efficiency, as measured by encounter problem density during a visit, will also improve. H2. Patient: The intervention will improve patients' perceptions of their visits on a variety of AHRQ CAHPS measures, such as physician knowledge of patient history. H3. Patient: The intervention will not impact the number or types of problems addressed during the visit. H4. Clinic: The intervention will not affect visit RVUs #Intervention - OTHER : Patient Overview Document - The Intervention has two components: 1. Pre-visit care coordination: * 5-7 days prior to a study patient's appointment with the doctor, the doctor's nurse/MA will call the study patient and collect pertinent clinical information using a data collection form we call a Patient Overview Document or POD. The purpose of the POD is to comprehensively inform the doctor about the patient before the doctor enters the exam room. * The nurse/MA will ensure that lab results, consultant reports, ER reports, imaging studies, etc., needed by the physician during the patient's visit, are available to the doctor in their usual place. 2. Team Meeting: On the day of the patient's appointment, prior to the beginning of the clinic session, the nurse/MA and doctor will jointly review the POD.

#Eligibility Criteria: Inclusion Criteria: * Must be greater than or equal to 65 years * Must be patients of participating physicians Exclusion Criteria: * Cannot speak English * Cannot hear well enough to respond to questions via the telephone or do not have a caregiver who can respond to questions on their behalf Sex : ALL Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: No

NCT01326637

{ "NCT_ID" : "NCT03368885", "Brief_Title" : "Evaluation of Integrating MIYCN Interventions in Existing CGPP of PCI", "Official_title" : "Evaluation of Integrating Selected MIYCN Interventions in Existing Polio Eradication Platform of Project Concern International (PCI) in UP", "Conditions" : ["Polio"], "Interventions" : ["Other: Maternal dietary diversity", "Other: Community mobilization", "Other: Use of existing platforms VHSND", "Other: Capacity Building", "Other: Exclusive Breast Feeding", "Other: Strategic use of data", "Other: Diet diversity in complementary feeding"], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-12-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12-24", "Study_Completion_Date(Actual)" : "2018-12-24}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-11-29", "First_Posted(Estimated)" : 2017-12-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-12-08", "Last_Update_Posted(Estimated)" : 2019-05-01", "Last_Verified" : 2019-04" } }}

#Study Description Brief Summary The study has two arms; both experimental and control areas will receive standard interventions given under polio eradication program of PCI. Participants in the experimental arm receive additional interventions on nutrition (improve diet diversity in pregnant women and children of 6-23 months) for exact 12 months. The study includes awareness generation (regarding nutrition) through community mobilization, counseling and capacity building of community mobilization. Detailed Description The experimental arm will receive the following interventions: 1. Interpersonal communication (IPC) to reach target women (Women in their 2nd or 3rd trimester of pregnancy and women with 6-23 months old child) to deliver messages on maternal nutrition package and complementary feeding through home visits made by Community Mobilization Coordinator (CMC). 2. Expanded community mobilization involving key influencers in family like husbands and mothers -in-law and community opinion leaders, religious leaders, Village Health Sanitation and Nutrition Committee (VHSNC) members. The aims are to improve awareness, shift norms and perceptions, engage husbands and local opinion leaders to promote healthy behaviour practices related to maternal nutrition and complementary feeding. 3. Strategic use of data to design a context-specific program and track the progress of the program with regards to impact on social norms and behaviors at household/community level and demonstrate the feasibility of integrating select MIYCN interventions in polio eradication platforms. 4. Convergence: The convergence will mainly focus on three Cs - maintain consistency, avoid conflict and enhance cooperation. This will aid in passing consistent MIYCN messages to the target community and ensure effective teamwork, collaboration and mutual support #Intervention - OTHER : Maternal dietary diversity - Counsel pregnant women for proper dietary intake and create awareness among family members and community to support her on maternal nutrition - OTHER : Diet diversity in complementary feeding - Counsel mothers of children of 6-23 months on diet diversity in complementary feeding by demonstration during home-visits and seek support from father and family members - OTHER : Exclusive Breast Feeding - Counselling on exclusive breast feeding among children under 6 months-Provide information to mothers of children of 3-6 months for exclusive breast feeding through home visits, and mothers meetings - OTHER : Community mobilization - Engagement of local/religious leader, husbands to support diet diversity for pregnant women and doctors and fathers to support diet diversity for complementary feeding - OTHER : Capacity Building - Capacity Building-Training of Community mobilization coordinator and mentoring for knowledge enhancement on nutrition for pregnant women and children below 2 years - OTHER : Use of existing platforms VHSND - Convergence- Strengthen Village Health Sanitation and Nutrition Day for creating awareness on diet diversity for maternal nutrition and complementary feeding - OTHER : Strategic use of data - Strategic use of data-Data analysis for concurrent monitoring,planning and decision making to improve the performance of CMCs

#Eligibility Criteria: Inclusion Criteria: For Community * * Women aged 15 <= age <= 49 years * Willing and able to provide consent * Women in 2nd and 3rd trimester of pregnancy and / or * Women with children aged 6 <= age <= 23 months For CMC * Women aged 18+ * Currently appointed a CMC in a selected HRA * Willing and able to provide consent Exclusion Criteria: * Women in first trimester of pregnancy * Women whose index child (youngest child, between 6 <= age <= 23 months of age) is not her biological child * Women whose index child is not currently living with the mother Sex : FEMALE Ages : - Minimum Age : 15 Years - Maximum Age : 49 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT03368885

{ "NCT_ID" : "NCT03595618", "Brief_Title" : "A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis", "Official_title" : "Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients With Knee Osteoarthritis. A 52-week International, Multi-regional, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study", "Conditions" : ["Osteoarthritis"], "Interventions" : ["Drug: Placebo", "Drug: GLPG1972"], "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)" : "2018-08-14", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-07-14", "Study_Completion_Date(Actual)" : "2020-07-14}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-07-11", "First_Submitted_that_Met_QC_Criteria" : 2021-04-20", "First_Posted(Estimated)" : 2018-07-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-07-20", "Last_Update_Posted(Estimated)" : 2021-07-28", "Last_Verified" : 2021-07" } }}

#Study Description Brief Summary This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis. #Intervention - DRUG : GLPG1972 - Film-coated tablets of GLPG1972 for oral use. - DRUG : Placebo - Film-coated tablets of matching placebo for oral use.

#Eligibility Criteria: Inclusion Criteria: * Male participants or female participants of non-childbearing potential and not breastfeeding. * Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2. * Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology. * History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month. * Symptom severity defined by a pain >= 40 mm and <= 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits. * Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics Exclusion Criteria: * Severe clinical knee malalignment according to the investigator. * Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side). * Knee prosthesis already foreseen within the study period (whichever side). * Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side). * Previous osteotomy on the inferior limbs (whichever side). * Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study. * Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study. * Other pathologies affecting the target knee. * Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil. Sex : ALL Ages : - Minimum Age : 40 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03595618

{ "NCT_ID" : "NCT04859933", "Brief_Title" : "AV Node Isolation in Atrial Fibrillation vs. Modulation by 'Pace and Ablate' Strategy", "Official_title" : "AV Node Isolation in Atrial Fibrillation vs. Modulation by 'Pace and Ablate' Strategy", "Conditions" : ["Atrial Fibrillation", "AV Node Ablation", "Escape; Rhythm"], "Interventions" : ["Procedure: AV-node ablation", "Procedure: AV-node isolation"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-10-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-02-28", "Study_Completion_Date(Actual)" : "2022-02-28}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-04-22", "First_Posted(Estimated)" : 2021-04-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-04-22", "Last_Update_Posted(Estimated)" : 2022-08-09", "Last_Verified" : 2022-08" } }}

#Study Description Brief Summary AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent atrial fibrillation with numerous side effects. The investigators hypothesised that an isolation of the AV node is concomitant with less occurrence of new bundle brunch blocks, more frequent preservation and higher rate of escape rhythm compared to AVNA. This retrospective study includes 20 patients being treated with AV-node isolation (AVNI) and 40 historical AVNA-controls. Among others these two methods were compared regarding escape rhythm, delta QRS, procedure time, ablation points, fluoroscopy time and total dose area product (DAP). #Intervention - PROCEDURE : AV-node isolation - Abaltion performed in the right atrium isolating the AV-node from the atrium - Other Names : - AVNI - PROCEDURE : AV-node ablation - Right sided ablation of the AV-node - Other Names : - AVNA

#Eligibility Criteria: Inclusion Criteria: * paroxysmal, persistend or permanent atrial fibrillation; indication for AVNA Exclusion Criteria: * other indications for AVNA than atrial fibrillation as AVNRT, atrial flutter, atrial tachycardia Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04859933

{ "NCT_ID" : "NCT02726971", "Brief_Title" : "Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion", "Official_title" : "A Prospective, Randomized, Controlled Trial Comparing 2 Different Doses of Estrogen Therapy After Hysteroscopic Adhesiolysis as an Adjuvant to Prevent Recurrence of Intrauterine Adhesions", "Conditions" : ["Asherman Syndrome"], "Interventions" : ["Drug: Femoston"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-08", "Study_Completion_Date(Actual)" : "2016-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-03-22", "First_Submitted_that_Met_QC_Criteria" : 2017-04-06", "First_Posted(Estimated)" : 2016-04-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-03-29", "Last_Update_Posted(Estimated)" : 2017-04-10", "Last_Verified" : 2017-04" } }}

#Study Description Brief Summary This single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion. #Intervention - DRUG : Femoston - Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.

#Eligibility Criteria: Inclusion Criteria: * Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score>=5); * Scheduled for hysteroscopic adhesiolysis; * Agreed to have two follow-up hysteroscopy; and * Written, informed consent obtained. Exclusion Criteria: * Received estrogen therapy within 3 months of enrollment; * Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS); * History of genital tuberculosis; and * Contraindication for estrogen therapy. Sex : FEMALE Ages : - Minimum Age : 25 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT02726971

{ "NCT_ID" : "NCT04814459", "Brief_Title" : "Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals", "Official_title" : "Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals", "Conditions" : ["Fall", "Risk Reduction"], "Interventions" : ["Other: HOP-UP-PT Program"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-05-15", "Study_Completion_Date(Actual)" : "2021-05-15}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-03-22", "First_Submitted_that_Met_QC_Criteria" : 2021-09-14", "First_Posted(Estimated)" : 2021-03-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-03-22", "Last_Update_Posted(Estimated)" : 2021-10-11", "Last_Verified" : 2021-09" } }}

#Study Description Brief Summary This novel study supports the positive benefits of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) to older adults identified as 'at-risk' by their local senior center after participating in a prevention-focused multimodal program provided by physical therapists in their home. Detailed Description The purpose of this study was to describe the outcomes of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) program participants and then to compare these outcomes to non-participants. 144 participants (n=72 per group) will be randomized to either the HOP-UP-PT intervention group or the Normal level of activity group. Six Michigan senior centers will refer adults ≥ 65 years who were at-risk for functional decline or falls. Licensed physical therapists will deliver physical, environmental, and health interventions within their approved scope of practice to the HOP-UP-PT intervention group during nine encounters (six in-person, three telerehabilitation) delivered over seven months. The Normal level of activity group participants are told to continue their usual physical activity routines during the same timeframe. Baseline and re-assessments are conducted at 0-, 3-, and 7-months for both the HOP-UP-PT intervention group and Normal level of activity group. Descriptions and comparisons from each assessment encounter will be analyzed. #Intervention - OTHER : HOP-UP-PT Program - Interventions provided to EG participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented.

#Eligibility Criteria: Inclusion Criteria: * Greater than or equal to 65 years * Senior Community Center staff identified them as 'at-risk' for decline in community dwelling status due to physical, social, economic, or community-related barriers * Willingness to participate Exclusion Criteria: * Received physical therapy services within the prior two months in any setting * Had been hospitalized within the prior two months * Were currently receiving palliative or hospice care * Mini Cog score less than 4 and Trail Making Part B score greater than 273 seconds * Outcomes American College of Sports Medicine exercise pre-participation health screening indicating physician clearance needed for participation and after evaluation the physician will not clear Sex : ALL Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT04814459

{ "NCT_ID" : "NCT03023644", "Brief_Title" : "Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study", "Official_title" : "Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study", "Conditions" : ["Congenital Heart Defect", "Executive Function", "Children", "Neurodevelopmental Disorders", "Working Memory", "Infant Open Heart Surgery"], "Interventions" : ["Behavioral: Cogmed Working Memory Training"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-02-21", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-01", "Study_Completion_Date(Actual)" : "2020-09-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-01-13", "First_Posted(Estimated)" : 2017-01-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-01-13", "Last_Update_Posted(Estimated)" : 2021-02-01", "Last_Verified" : 2021-01" } }}

#Study Description Brief Summary Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD), making it the most common birth defect. With recent medical advances, more children with CHD survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with CHD. These survivors face challenges in terms of their cognitive and behavioral development. For many, the limitations affect their academic achievement, social adaption and, ultimately, their quality of life. Among the most disabling limitations are those that pertain to the ability to maintain attention, plan and organize activities, regulate emotions, and develop problem-solving strategies. Collectively, these are referred to as executive functions (EF) because they are higher-order abilities that enable one to coordinate complex behaviors. Additionally, impaired EF also underlie mental health disorders. In spite of the abundance of evidence that children with CHD struggle with EF, there is little to offer them in the way of evidence-based interventions to prevent or mitigate these problems. The investigators propose to conduct the first randomized trial to evaluate the efficacy of an intervention, the Cogmed Working Memory Program, in improving the neurodevelopment outcomes of children with critical CHD after infant open-heart surgery. Children who meet eligibility criteria and who agree to participate will be randomly assigned to an intervention or control group. Children in the intervention group will complete 25 35-40 minute sessions of Cogmed training, spread over for 5 weeks. This Program is a set of home-based, child-friendly, computerized activities. The control group will receive the standard of care for children with CHD. Children's scores on EF and related neurodevelopmental tests will be evaluated before the intervention group completes Cogmed training, at the conclusion of their training, and 3 months later. The latter assessment will indicate whether any gains in EF skills of the children in the intervention group are sustained after training. Parents and teachers will also complete questionnaires about children's EF, attention, and social behaviors to determine whether training affects behaviors of the intervention group at home and in school. The investigators will also identify the medical and surgical characteristics of children who benefit most from Cogmed training. This information will be helpful in targeting the intervention most efficiently in the future. #Intervention - BEHAVIORAL : Cogmed Working Memory Training - Cogmed Working Memory Program will be used as a computerized home-based intervention. Families will an iPad with a web-based software program. The 25 sessions will be completed individually by the child with parental supervision. For the first 5 sessions, the participant trains on the same set of games; on the 6th session and every 5th session thereafter, a new task is introduced and replaces one of the initial tasks. At the end of each session, the child can play an age-appropriate computerized game as a reward. After each session, results are uploaded by parents to a secure website, to keep track of the participant's progress. Families will be contacted weekly to check program function and discuss concerns.

#Eligibility Criteria: Inclusion Criteria: * Open heart surgery before age 12 months of life * Ages between 7 years 0 months and 12 years 11 months * >=6 months post-cardiac surgery at enrollment * Cardiology follow-up (clinic or inpatient) at BCH or other affiliated center in the last 6 years. * English and/or Spanish speaking * Informed consent of parent/guardian as well as assent of child Exclusion Criteria: * Known chromosomal anomalies and/or genetic syndromes * Severe physical and/or sensory impairments (hearing, visual, or psychomotor) that would prevent use of the computerized program and tablets * Confirmed formal diagnosis of any autism spectrum disorder or a severe developmental and/or intellectual disorder that would prevent successful completion of the planned study testing. * Scheduled to undergo major cardiac interventions in the 6 months following enrollment * Received, receiving, or scheduled to receive Cogmed or any other computerized behavioral training program targeting executive functions or ADHD Sex : ALL Ages : - Minimum Age : 7 Years - Maximum Age : 12 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT03023644

{ "NCT_ID" : "NCT03093155", "Brief_Title" : "Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab", "Official_title" : "A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers", "Conditions" : ["Epithelial Ovarian Cancer", "Fallopian Tube Cancer", "Primary Peritoneal Cancer"], "Interventions" : ["Drug: Ixabepilone", "Drug: Bevacizumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-04-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-29", "Study_Completion_Date(Actual)" : "2022-12-29}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-03-22", "First_Submitted_that_Met_QC_Criteria" : 2024-04-17", "First_Posted(Estimated)" : 2017-03-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-03-27", "Last_Update_Posted(Estimated)" : 2024-05-14", "Last_Verified" : 2024-04" } }}

#Study Description Brief Summary This is a randomized, two-arm, open-label Phase II multicenter study designed to examine the effects of adding bevacizumab to ixabepilone for the treatment of patients who have recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Its primary objective is to assess whether adding bevacizumab to ixabepilone improves progression-free survival in its target population. Study participants will be stratified by (a) study site and (b) previous receipt of bevacizumab prior to randomization. Detailed Description The primary objective of this study is as follows: * To assess the activity of ixabepilone with bevacizumab compared to ixabepilone alone in patients with recurrent or persistent platinum-resistant/refractory epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. We will assess this by comparing the ixabepilone +bevacizumab (experimental) arm to the ixabepilone-alone (control) arm for an improvement in median progression free survival (PFS). The secondary objectives of this study are as follows: * To compare the experimental arm to the control arm for increases in objective response rate (ORR) and durable disease control rate (DDCR). * To compare the experimental arm to the control arm for an increase in overall survival (OS). * To assess the safety profile of ixabepilone in combination with bevacizumab in ovarian, fallopian tube, or primary peritoneal cancer patients. * To assess whether prior treatment with bevacizumab impacts future response to bevacizumab in combination with ixabepilone. In addition to the primary and secondary objectives of this study, there are additional exploratory/correlative objectives. The exploratory/correlative objectives of this study are as follows: * To characterize number, length and composition (e.g., class III β-tubulin expression) of microtentacles (McTNs) isolated from circulating tumor cells isolated from whole blood of patients undergoing treatment with ixabepilone with or without bevacizumab, and correlate with best response, PFS, and OS. * To observe McTNs on circulating tumor cells in blood using a novel polyelectrolyte multi-layer (PEM) tethering technology. * To correlate ex vivo response of McTNs to drug treatment with clinical response in order to develop a real-time assay to predict response to therapy. * To explore use of circulating tumor (ct) DNA as a biomarker for disease response and compare its performance to CA-125. * To examine whether clinical response to ixabepilone with or without bevacizumab differs between high and low expressors of class III β-tubulin. #Intervention - DRUG : Ixabepilone - Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response - Other Names : - Ixempra - DRUG : Bevacizumab - Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion. Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response. - Other Names : - Avastin

#Eligibility Criteria: Inclusion Criteria: * Patients must have platinum-resistant/refractory (i.e., platinum-free interval <6 months) recurrent or persistent histologically confirmed epithelial (non-mucinous) ovarian, fallopian tube, or primary peritoneal cancer. Patients may have serous, endometrioid, clear cell, carcinosarcoma, or transitional cell/malignant Brenner, mixed, or undifferentiated histologies. * Patients must have specimen available for immunohistochemistry for class III β-tubulin status; recurrent tumor specimen is preferred, though this may be performed on primary tumor if no recurrent tumor is available. * All patients must have measurable disease. Measurable disease is defined as lesions that can be measured by physical examination or by means of medical imaging techniques. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be >= 20 mm when measured by conventional techniques, including palpation or plain x-ray, or >= 10 mm when measured by spiral CT and/or MRI. Ascites and pleural effusions are not to be considered measurable disease. * Patients must have at least one 'target lesion' to be used to assess response on this protocol as defined by RECIST v1.1 Tumors within a previously irradiated field will be designated as 'non-target' lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy. * At the time of initial surgery, patients may have been optimally (<1 cm diameter residual disease) or sub-optimally (>=1 cm diameter of residual disease) debulked. * Patients with measurable recurrent disease of any previous stage (I-IV) are eligible to enrollment. * The diagnosis must be histologically confirmed by a gynecologic pathologist. * Patients must have adequate bone marrow, kidney, and liver function: 1. Absolute neutrophil count greater than or equal to 1500 cells/mm3 2. Platelets greater than or equal to 100,000/uL 3. Renal function: creatinine less than or equal to 2.0 mg/dL 4. Hepatic function: Bilirubin <= 1.5 X laboratory normal 5. SGOT/SGPT <= 3 X laboratory normal. * Patients must have an ECOG performance status of 0 <= age <= 2. * Patients must have signed an approved informed consent. * Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy. They should be free of significant infection. * Patients must have received prior treatment with taxanes. There is no limit on the number of prior lines of therapy. * Patients may have received prior bevacizumab therapy alone or in combination with chemotherapy. A 3-week washout period is required. * Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception (section 7.5.3). * Patients must be at least 18 years. Exclusion Criteria: * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers, are excluded if there is any evidence of other malignancy present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. * Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within 6 months of registration (NYHA classification III-IV). * Patients with any unstable medical issue (including cardiac issues as above, active treatment for symptomatic pulmonary embolism, CVA, renal or hepatic insufficiency, active infection/sepsis requiring intravenous antibiotics). In patients who have undergone surgery, 28 days should elapse before initiation and the surgical site should be adequately healed. * Known brain/leptomeningeal involvement of the disease, active neurological disease such as uncontrolled seizure disorder or moderate to severe dementia. * Patients who have received prior therapy with any covalent irreversible anti-angiogenic tyrosine kinase inhibitor (e.g., vandetanib). * Patients known to be seropositive for human immunodeficiency virus (HIV) and active hepatitis, even if liver function studies are in the eligible range. * Known hemorrhagic diathesis or active bleeding disorder, including platelet count <100,000/uL, or inadequate granulocytes, including an absolute neutrophil count <1500 cells/mm. * Any hypersensitivity to Cremophor® EL or polyoxyethylated castor oil. * CTCAE grade 2 or higher peripheral neuropathy. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03093155

{ "NCT_ID" : "NCT01184105", "Brief_Title" : "A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation", "Official_title" : "A Phase I, Single-Center, Double-Blind, Randomized, Placebo-Controlled, Safety and Pharmacokinetic Study to Evaluate Systemic and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites, 2,6-Dimethylaniline (2,6-DMA) and O-Toluidine, in Female Healthy Volunteer Subjects Following Daily Application of 60 mg PSD502 or Placebo to the Vagina and Cervix for 7 Days", "Conditions" : ["Premature Ejaculation"], "Interventions" : ["Drug: Intervention A", "Drug: Intervention B"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-11", "Study_Completion_Date(Actual)" : "2010-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-08-16", "First_Posted(Estimated)" : 2010-08-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-08-17", "Last_Update_Posted(Estimated)" : 2016-08-10", "Last_Verified" : 2015-09" } }}

#Study Description Brief Summary A phase I, single-center, double-blind, randomized, placebo-controlled, safety and pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and prilocaine and the metabolites, 2,6-dimethylaniline (2,6-DMA) and o-toluidine, in female healthy volunteer subjects following daily application of 60 mg PSD502 or placebo to the vagina and cervix for seven days Detailed Description The study drug is a metered-dose anesthetic spray, which is being developed for the treatment of premature ejaculation (PE). The use of anesthetic in topical creams has been well established. The use of a cream does not result in the concentrated drug being in direct contact with the cells, unlike the spray. Seven clinical studies have already been carried out for the spray in the development of PE. These studies have demonstrated a prolongation of intravaginal ejaculatory latency time and no safety concerns for male patients or their female partners. The partners of clinical study participants have been asked to report health changes during the studies. Reports of vaginal numbness were uncommon; however, effects of the transfer to a partner cannot be excluded. This study is being conducted to investigate in detail the systemic exposure to PSD502 spray in order to assess safety in the female partner. The dose level has been chosen because the total dose applied to the male glans penis is 30 mg, and thus it is potentially possible that his partner could be exposed to this dose. Therefore, the 60 mg dose was chosen to provide safety information with a higher margin of exposure. #Intervention - DRUG : Intervention A - A single dose of 60 mg will consist of 6 sprays of the 10 mg strength spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays) - DRUG : Intervention B - A dose of placebo will consist of 6 sprays of the placebo spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays)

#Eligibility Criteria: Inclusion Criteria: * Female non-smokers aged 18 years and over * Willing and able to provide written informed consent * Generally, in good health in the opinion of the investigator * Subject must have a body mass index between 18 and 30 kg/m2, inclusive * Willing and able to comply with all study procedures in the opinion of the investigator * Negative Papanicolaou (Pap) smear performed during gynecological examination at screening (i.e., Pap smear result that reads negative for any intraepithelial lesions and reparative or reactive changes and with no sign or presence of infection [e.g., bacterial vaginosis, candida, bacterial flora, etc]) * Negative drugs of abuse and cotinine test at screening * Female subjects of child-bearing potential who are sexually active or become sexually active must be using a method of effective contraception from 14 days before screening and continue to use until the end of the study. If oral contraceptives are used, these must have been stable for a period of 3 months. If a barrier method is being used, this should be latex based and not polyurethane based * Female subjects who are post-menopausal must have been post-menopausal >1 year and have confirmed elevated serum follicle stimulating hormone at screening Exclusion Criteria: * History of a significant medical condition that would preclude further study participation in the opinion of the investigator * Currently taking, or has taken within the 2 weeks prior to screening, any concomitant medication that could confound interpretation of the safety or pharmacokinetic data on PSD502. Use of prescription medication within 14 days or over-the-counter products within 7 days prior to first dose * Suffering from a sexually transmitted disease, or is positive for hepatitis B, hepatitis C, human papillomavirus, or human immunodeficiency virus infection * Safety testing: abnormalities at screening, in particular liver function tests, that are indicative of a medical condition and that would preclude further participation in the opinion of the investigator * Significant abnormality of the vaginal mucosa or cervix that would preclude interpretation of the examination of these areas or that could be worsened by use of PSD502 * History of alcohol or drug abuse within 1 year prior to screening * Known drug sensitivity to amide-type local anesthetics * Unlikely to understand or be able to comply with study procedures, for any reason, in the opinion of the investigator * History of glucose-6-phosphate dehydrogenase deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g., anti-malarial agents) * Use of class I (e.g., mexiletine, tocainide) and III (e.g., amiodarone, sotalol) anti-arrhythmic drugs * Subject has received an investigational (non-registered) drug within 60 days of screening * Subjects having any physical or psychological condition that would prevent them from undertaking the study procedures, including but not limited to, the following: * Uro-gynecological disease or recent genito-urinary surgery within 8 weeks of screening which would make intravaginal application or vaginal examination/colposcopy difficult or painful or * Ongoing significant psychiatric disorder (e.g., bipolar disease, depression/anxiety disorder or schizophrenia) * Subject has a clinically obvious vaginal infection, such as active vaginal Candida albicans (thrush), or other abnormal vaginal discharge * Subjects who are pregnant or lactating * Subjects should not be menstruating during the treatment phase * Donation of blood or blood products within 60 days prior to dosing or at any time during the study, except as required by this protocol 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

NCT01184105

{ "NCT_ID" : "NCT05605080", "Brief_Title" : "Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery", "Official_title" : "Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery", "Conditions" : ["Hemorrhoids", "Anal Fistula"], "Interventions" : ["Other: Bosmin gauze", "Device: Gelfoam"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-11-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-10-30", "Study_Completion_Date(Actual)" : "2023-11-20}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-10-29", "First_Posted(Estimated)" : 2022-11-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-11-02", "Last_Update_Posted(Estimated)" : 2023-11-22", "Last_Verified" : 2023-11" } }}

#Study Description Brief Summary To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery. Detailed Description Hemorrhoidectomy and fistulotomy these two types of anal surgery are common surgeries in colon and rectal surgery division in Shuang Ho hospital. For these patients underwent surgical treatment, some surgeons used gauze with Bosmin for hemostasis and analgesia after surgery, and other surgeons used Gelfoam. These choices were often determined by surgeon's personal preference according to their experiences. Shuang Ho hospital has top three quantity of hemorrhoidectomy in Taiwan. So, a randomized controlled trial is conducted to evaluate the difference between hemostatic agents use after anal surgery. #Intervention - DEVICE : Gelfoam - Use Gelfoam as a hemostatic agent after anal surgery. - OTHER : Bosmin gauze - Use bosmin gauze as a hemostatic agent after anal surgery.

#Eligibility Criteria: Inclusion Criteria: * Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include. * Patients who undergo fistulectomy or fistulotomy are include. Exclusion Criteria: * Emergency operation * Patients with colorectal cancer * Liver cirrhosis * Patients with coagulopathy * Patients with HIV infection Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05605080

{ "NCT_ID" : "NCT03917849", "Brief_Title" : "Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy", "Official_title" : "Efficacy of Inertial Flywheel vs Heavy Slow Resistance Training Among Athletes With Patellar Tendinopathy", "Conditions" : ["Patellar Tendinitis", "Jumper's Knee"], "Interventions" : ["Behavioral: Exercises program for patellar tendinopathy"], "Location_Countries" : ["Argentina"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-01-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-03-22", "Study_Completion_Date(Actual)" : "2020-03-22}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-04-08", "First_Posted(Estimated)" : 2019-04-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-04-13", "Last_Update_Posted(Estimated)" : 2020-07-15", "Last_Verified" : 2020-07" } }}

#Study Description Brief Summary The purpose of this project is to investigate the efficacy of Inertial Flywheel Resistance program vs Heavy slow resistance in patients with chronic patellar tendinopathy. The investigators hypothesize that Inertial Flywheel Resistance program will yield a more positive clinical outcome and function in patients with patellar tendinopathy compared to heavy slow resistance group. Detailed Description Randomized controlled intervention study #Intervention - BEHAVIORAL : Exercises program for patellar tendinopathy - To compare the effectiveness of the inertial flywheel resistance program versus slow heavy resistance in patients with chronic patellar tendinopathy

#Eligibility Criteria: Inclusion Criteria: * Clinical diagnosis of patellar tendinopathy * Symptoms > 3 months * Pain localized to the inferior pole of the patella * Victorian Institute of Sport Assessment (VISA) score less than 80 points * Palpation tenderness of the patellar tendon * Abnormal tendon (hypoechoic) confirmed by ultrasonography. Exclusion Criteria: * Previous knee surgery * Confounding diagnosis to the knee joint * Previous corticosteroids injections * Arthritis or diabetes 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: No

NCT03917849

{ "NCT_ID" : "NCT05266053", "Brief_Title" : "Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections", "Official_title" : "Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections", "Conditions" : ["Hypertrophic Skin Condition of Anterior Abdomen"], "Interventions" : ["Other: Standard wound dressing", "Device: PICO 7 dressing"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-07-28", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-05-01", "Study_Completion_Date(Actual)" : "2023-05-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-02-01", "First_Submitted_that_Met_QC_Criteria" : 2024-08-28", "First_Posted(Estimated)" : 2022-03-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-03-02", "Last_Update_Posted(Estimated)" : 2024-09-03", "Last_Verified" : 2024-08" } }}

#Study Description Brief Summary There are millions of births each year with 32% of women undergoing cesarean sections (C-sections), which results in skin scarring. Repeat C-sections increased by 178% from 1979-2010. Given the frequency of C-sections, it is important to achieve a desirable cosmetic outcome. The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. This study aims to compare the aesthetic appearance by using The Patient and Observer Scar Assessment Scale (POSAS) scar assessment scale following closed incision negative pressure therapy with a PICO 7 dressing to the standard abdominal dressing in women undergoing repeat cesarean sections Detailed Description Single, randomized controlled trial in women undergoing a repeat cesarean delivery. Women will be randomized to placement of a PICO 7 dressing or a standard abdominal dressing at the time of cesarean. The standard abdominal dressing will be removed approximately on postoperative day (POD) 1-2 and the PICO 7 dressing will be removed approximately on POD 3-4 (prior to discharge). If the patient with a PICO dressing remains inpatient for longer than 7 postoperative days, the PICO dressing will be removed prior to POD 7, in accordance with device instructions. Participants in both groups will be sent POSAS surveys at the two, four and six week visit window with primary outcome being aesthetic appearance (cosmesis) at six weeks. Observers (healthcare providers) will complete a POSAS survey at the postpartum visit (\~4-6 weeks postoperative) to rate scar quality. #Intervention - DEVICE : PICO 7 dressing - The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. - OTHER : Standard wound dressing - Standard abdominal dressing at the time of cesarean

#Eligibility Criteria: Inclusion Criteria: * Scheduled or non-labor repeat cesarean delivery * One or more prior cesarean section(s) with prior pfannenstiel incision scar * Gestational > 23 yearsweeks * Age 18 and older Exclusion Criteria: * Patients with malignancy in the wound bed or margins of the wound * Non-enteric and unexplored fistulas * Necrotic tissue with eschar present * Exposed arteries, veins, nerves or organs * Exposed anastomotic sites * Cellulitis or evidence of active infection * Known allergy to adhesive tape * Patient unwilling to follow-up * Contraindication to NPWT * Bleeding disorder * Therapeutic anticoagulation * Allergy to any component of the dressing (perhaps list these as you will need to know to confirm eligibility of each patient) * Prior irradiated skin 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

NCT05266053

{ "NCT_ID" : "NCT02287116", "Brief_Title" : "Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial", "Official_title" : "Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial", "Conditions" : ["Bronchopulmonary Dysplasia", "Death"], "Interventions" : ["Device: Easy Flow system and INCA® nasal cannulae set"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-05", "Study_Completion_Date(Actual)" : "2014-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-11-02", "First_Posted(Estimated)" : 2014-11-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-11-05", "Last_Update_Posted(Estimated)" : 2014-11-10", "Last_Verified" : 2014-11" } }}

#Study Description Brief Summary The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP (nasal continuous positive airway pressure)as the initial respiratory support when using minimal ly invasive surfactant therapy (MIST) in preterm infants. Detailed Description OBJECTIVE: To determine that affect the rate of (bronchopulmonary dysplasia) BPD and death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for respiratory distress syndrome (RDS). METHODS: Inborn preterm infants of gestational age 26-32 weeks, with respiratory distress syndrome were enrolled in this single-centered, unblinded randomized prospective controlled trial. They were stabilized with T-piece device in delivery room. Immediately after admission of neonatal intensive care unit (NICU), infants were randomly assigned to receive NCPAP with either nasal prongs or mask. NCPAP was continued by setting at PEEP as 5 to 8 cm H2O . RESULTS: 160 infants were assessed for eligibility 149 infants were randomized. Finally 75 infants in Group I (nasal prong) and 74 in Group II (nasal mask) were analyzed. Mean gestational ages were 29.3±1.6 vs 29.1±2.0 weeks (p=0.55) and birth weights were 1225±257 vs. 1282±312 grams (p=0.22) respectively in Group I and Group II. The frequency of NCPAP failure within 24 hours of life was higher in Group I compared to Group 2 (respectively 8%, %0 , p=0.09) but difference was not significant. The outcomes of BPD and death rates did not differ among the groups ( Group I 9.3% vs. Group II 9.4 %; p=0.96). CONCLUSIONS: Applied nasal mask is a feasible method to deliver NCPAP and as effective as nasal prongs for the initial treatment of RDS in preterm infants. #Intervention - DEVICE : Easy Flow system and INCA® nasal cannulae set

#Eligibility Criteria: Inclusion Criteria: * One hundred sixty infants born at 26 <= age <= 32 weeks' gestation not endotracheally intubated in the delivery room (DR) Exclusion Criteria: * Infants with major congenital anomalies, and who required intubation in the DR and no parental consent were excluded. Sex : ALL Ages : - Maximum Age : 1 Year - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes

NCT02287116

{ "NCT_ID" : "NCT02679053", "Brief_Title" : "Aerobic Exercise as add-on Treatment for Inpatients With Depression", "Official_title" : "Aerobic Exercise as add-on Treatment for Inpatients With Depression: Effects and Biomarkers", "Conditions" : ["Depression"], "Interventions" : ["Behavioral: Placebo control", "Behavioral: Aerobic exercise"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-02", "Study_Completion_Date(Actual)" : "2017-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-01-26", "First_Posted(Estimated)" : 2016-02-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-02-05", "Last_Update_Posted(Estimated)" : 2017-04-11", "Last_Verified" : 2017-04" } }}

#Study Description Brief Summary The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as adon treatment for moderately to severely depressed inpatients. Endpoints are symptom severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV). Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post (+6weeks) in already existing blood samples. Detailed Description Patients are randomly assigned to the intervention group (IG) or control group (CG). The IG will train three times per week on indoor bicycles at 60 to 75% of maximal heartrate aiming at a weekly total of 17.5kcal/kg bodyweight for 6 consecutive weeks. The exercise will take place under supervision. CG will absolve a basic stretching and mobilisation program 3 times per week, also under supervision for 6 consecutive weeks. At the end of every week physical fitness is evaluated by the queens step test. No other activities with moderate or high intensity are allowed throughout the intervention time. All patients will participate in the multimodal treatment program of the depression ward, which includes pharmacotherapy, psychotherapy and specialized therapies such as art therapy and ergotherapy. #Intervention - BEHAVIORAL : Aerobic exercise - BEHAVIORAL : Placebo control

#Eligibility Criteria: Inclusion Criteria: * Inpatient treatment on the Depression ward * International Classification of Diseases (ICD)-10: F32, F33 or F31 * HDRS-17>16 Points * written informed consent Exclusion Criteria: * Any physical condition that prohibits endurance exercise * 3 or more cardiovascular risk factors (hypertonia, family history, smoking, hypertriglyceridemia, diabetes) * pathological ECG * BMI > 35 kg/m2 * Pregnancy * acute suicidal Ideation * comorbid substance dependence (except nicotine) * Major comorbid psychiatric disorder * regular high intensity exercise prior to treatment Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT02679053

{ "NCT_ID" : "NCT05459324", "Brief_Title" : "Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II", "Official_title" : "Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording: Phase II", "Conditions" : ["Chronic Pain", "Neuropathic Pain", "Failed Back Surgery Syndrome", "Complex Regional Pain Syndromes"], "Interventions" : ["Device: HD Study Electrode"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DEVICE_FEASIBILITY", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-06-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-12-31", "Study_Completion_Date(Actual)" : "2023-12-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-07-12", "First_Posted(Estimated)" : 2022-07-14" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-07-12", "Last_Update_Posted(Estimated)" : 2024-07-16", "Last_Verified" : 2024-07" } }}

#Study Description Brief Summary The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ('Study Electrode') is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval. #Intervention - DEVICE : HD Study Electrode - The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

#Eligibility Criteria: Inclusion Criteria: * patients undergoing a spinal cord stimulation procedure for neuropathic pain. * have undergone a successful SCS trial and are determined eligible for a permanent SCS implant. * Patients must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.- * subjects must be able to give informed consent. Exclusion Criteria: * patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain 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

NCT05459324

{ "NCT_ID" : "NCT00217971", "Brief_Title" : "Dronabinol Treatment for Marijuana Addiction", "Official_title" : "A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction", "Conditions" : ["Marijuana Abuse"], "Interventions" : ["Drug: Placebo", "Drug: Dronabinol"], "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)" : "2005-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-12", "Study_Completion_Date(Actual)" : "2009-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2005-09-16", "First_Submitted_that_Met_QC_Criteria" : 2011-10-19", "First_Posted(Estimated)" : 2005-09-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2005-09-16", "Last_Update_Posted(Estimated)" : 2019-04-24", "Last_Verified" : 2019-04" } }}

#Study Description Brief Summary The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal. Detailed Description Marijuana addiction is associated with significant withdrawal symptoms, including anxiety, irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the effectiveness of dronabinol in reducing withdrawal symptoms. During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, vital signs, self-report ratings, and urine samples will be collected. Participants will have a follow-up evaluation at month 6. #Intervention - DRUG : Dronabinol - Dronabinol - Other Names : - Marinol - DRUG : Placebo - placebo

#Eligibility Criteria: Inclusion Criteria: * men and women between the ages of 18 <= age <= 60 * Meets DSM-IV criteria for current marijuana dependence and reports marijuana as primary drug of abuse * Individuals must report using marijuana at least 5 days a week and have a marijuana positive urine drug screen on the day of study entry * Individuals must be capable of giving informed consent and capable of complying with study procedures. * Women of child-bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued. Exclusion Criteria: * Meets criteria for current psychiatric disorder requiring psychiatric intervention. Disorders that are stable on psychotherapy or pharmacotherapy will not be exclusionary. Individuals will be permitted to take prescribed zolpidem and zaleplon if there is no evidence of dependence on these substances. * History of seizures * Known sensitivity to dronabinol * Unstable medical conditions * Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification * Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia * Pregnant or breast-feeding * Individuals who have exhibited suicidal or homicidal behavior within the past two years or who have current active suicidal ideation. * Individuals with coronary vascular disease as indicated by history of abnormal ECG or history of cardiac symptoms. * Unstable physical disorder which might make participation hazardous such as uncontrolled hypertension (SBP > 150, DBP> 90, or HR > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases < 2 <= age <= 3X upper limit of normal are acceptable), or medically unstable diabetes. * Subjects in professions in which even mild intoxication would be hazardous (e.g., police officer, bus driver, firefighter). * Individuals who are court-mandated to treatment. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT00217971

{ "NCT_ID" : "NCT02765464", "Brief_Title" : "Acute Kidney Injury in Critically Ill Patients", "Official_title" : "Predicting Acute Kidney Injury in Critically Ill Trauma Patients Using Metalloproteinase 2 (TIMP2) and Insulin-like Growth Factor Binding Protein7 (IGFBP 7)", "Conditions" : ["Acute Renal Injury"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-10-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-11-30", "Study_Completion_Date(Actual)" : "2019-11-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-05-04", "First_Posted(Estimated)" : 2016-05-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-05-05", "Last_Update_Posted(Estimated)" : 2021-10-26", "Last_Verified" : 2021-10" } }}

#Study Description Brief Summary Acute kidney injury (AKI) in critically ill trauma patients has been shown to significantly increase mortality, length of stay, and costs, however detection has proven difficult as markers like elevated creatinine and decreased urine output may take days to manifest and are late indicators of AKI. The combination of two urinary biomarkers, Tissue Inhibitor of Metalloproteinase 2 (TIMP-2) and Insulin-like Growth Factor Binding Protein 7 (IGFBP-7), has been shown to increase within 12 hours following renal insult, allowing assessment of risk for developing acute kidney injury. Therefore, the investigators plan to assess if acute kidney injury in critically ill trauma patients can be determined earlier using urinary TIMP-2 and IGFBP-7 via the NephroCheck testing system. These markers have not been specifically evaluated in trauma patients at risk of AKI.

#Eligibility Criteria: Inclusion Criteria: * trauma patients with multiple injuries; * abdominal injuries; * crush injuries; * those who present in shock (systolic blood pressure <90 or mean arterial pressure <65); * require blood transfusions, vasopressors or mechanical ventilation Exclusion Criteria: * known pregnancy; * patients under 21 years; * known moderate to severe AKI prior to enrollment and end stage renal disease. known moderate to severe AKI prior to enrollment and end stage renal disease Sex : ALL Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02765464

{ "NCT_ID" : "NCT01989156", "Brief_Title" : "Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting", "Official_title" : "A Randomized, Controlled, Open-label, 3-arm Parallel Group, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Apparently Healthy Smokers Switching to the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) or Observing Smoking Abstinence, Compared to Continuing to Use Menthol Conventional Cigarettes, for 5 Days in Confinement and Prolonged by 86 Days in an Ambulatory Setting", "Conditions" : ["Smoking"], "Interventions" : ["Other: Menthol Conventional Cigarette (mCC)", "Other: THS 2.2 Menthol (mTHS 2.2)", "Other: Smoking Abstinence (SA)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-10", "Study_Completion_Date(Actual)" : "2015-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-11-14", "First_Submitted_that_Met_QC_Criteria" : 2017-02-17", "First_Posted(Estimated)" : 2013-11-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-11-19", "Last_Update_Posted(Estimated)" : 2020-03-24", "Last_Verified" : 2020-03" } }}

#Study Description Brief Summary Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs). Detailed Description The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS) for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction. #Intervention - OTHER : THS 2.2 Menthol (mTHS 2.2) - THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting - OTHER : Menthol Conventional Cigarette (mCC) - Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting - OTHER : Smoking Abstinence (SA) - SA for 5 days in confinement prolonged by 86 days in an ambulatory setting

#Eligibility Criteria: Inclusion Criteria: * Smoking, apparently healthy subject as judged by the Investigator. * Subject smokes at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks, based on self-reporting. * Subject has smoked for at least the last 3 consecutive years. * Subject does not plan to quit smoking within the next 6 months. Exclusion Criteria: * As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason). * The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity. * For women: Subject is pregnant or is breast feeding. * For women: Subject does not agree to use an acceptable method of effective contraception. Sex : ALL Ages : - Minimum Age : 22 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01989156

{ "NCT_ID" : "NCT01590147", "Brief_Title" : "Supportive Intervention Programs Study", "Official_title" : "Supportive Intervention Programs to Lessen Treatment Related Symptoms", "Conditions" : ["Fatigue", "Nausea and Vomiting", "Pain", "Recurrent Colon Cancer", "Recurrent Rectal Cancer", "Stage I-IVB Colon Cancer", "Stage I-IVB Rectal Cancer"], "Interventions" : ["Other: educational intervention", "Other: laboratory biomarker analysis", "Procedure: Yoga therapy", "Other: assessment of therapy complications", "Other: questionnaire administration", "Procedure: management of therapy complications", "Procedure: quality-of-life assessment"], "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)" : "2011-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-07", "Study_Completion_Date(Actual)" : "2013-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-05-01", "First_Posted(Estimated)" : 2012-05-02" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-05-01", "Last_Update_Posted(Estimated)" : 2018-08-15", "Last_Verified" : 2018-08" } }}

#Study Description Brief Summary This randomized clinical trial studies the preliminary efficacy of a yoga skills training (YST) compared to counseling and education (CE) for reducing treatment-related symptoms in patients with colorectal cancer who are receiving chemotherapy. The YST may reduce fatigue, other treatment-related symptoms, and improve the quality of life (QOL) of patients with colorectal cancer. It is not yet known whether YST is more effective then CE in reducing these outcomes. Detailed Description OBJECTIVES: I. To establish the feasibility of implementing a YST among patients undergoing chemotherapy. This includes the feasibility of implementing yoga in a treatment setting, and patient recruitment, adherence, and retention. II. To obtain preliminary data on the efficacy of a YST for reducing fatigue among patients undergoing chemotherapy. III. To obtain exploratory data on the impact of a YST on other treatment-related symptoms (e.g., pain, distress, nausea) and QOL. IV. To obtain exploratory data on the impact of a YST on potential psychological (self-efficacy for coping with cancer, response expectancies for symptoms) and physiological (interleukin \[IL\]-6 \[IL-6\], IL-1 Receptor Antagonist \[IL-1Ra\], tumor necrosis factor- alpha \[TNF-a\], soluble TNF receptor I \[sTNFRI\], C-reactive protein \[CRP\]) mediators that may explain the impact of the YST on fatigue. OUTLINE: Patients (n=20) are randomized to 1 of 2 treatment arms. ARM I: Patients participate in three 15-minute YST sessions, comprising awareness meditation practice, movement practice, and breathing practice and relaxation. Patients also receive a compact disc (CD) recording of a 15-minute YST session and are instructed to practice the YST at home 4 times weekly. ARM II: Patients participate in three 15-minute CE sessions, comprising empathic attention with an interventionist who allows patients to direct the flow of conversation and provides supportive comments according to standardized procedures. Patients also receive CDs with recorded information related to coping with colorectal cancer similar in length to the suggested practice time in Arm I. The interventions (Week 2, Week 4, Week 6) and assessments (Week 0, Week 4, Week 8) are implemented during visits for chemotherapy (every two weeks). #Intervention - PROCEDURE : Yoga therapy - receive YST - OTHER : questionnaire administration - Ancillary studies - PROCEDURE : quality-of-life assessment - Ancillary studies - OTHER : laboratory biomarker analysis - Correlative studies - OTHER : assessment of therapy complications - Ancillary studies - PROCEDURE : management of therapy complications - Receive YST or CE - Other Names : - complications of therapy, management of - OTHER : educational intervention - Receive CE

#Eligibility Criteria: Inclusion Criteria: * Signed protocol specific informed consent * Are diagnosed with colorectal cancer * Recruited within 2 weeks of initiating chemotherapy (including reinitiating chemotherapy after a treatment holiday of greater than or equal to 4 weeks) * Able to understand written and spoken English Exclusion Criteria: * Under age 18 (children with colorectal cancer) * Unable to read or understand English * Vulnerable subjects (except those who are economically or educationally disadvantaged) 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

NCT01590147

{ "NCT_ID" : "NCT01346033", "Brief_Title" : "Evaluation of SCOUT DS in Subjects With Type 2 Diabetes", "Official_title" : "An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes", "Conditions" : ["Type 2 Diabetes"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-10", "Study_Completion_Date(Actual)" : "2010-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-04-28", "First_Posted(Estimated)" : 2011-05-02" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-04-29", "Last_Update_Posted(Estimated)" : 2012-12-04", "Last_Verified" : 2012-12" } }}

#Study Description Brief Summary The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes. Detailed Description Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.

#Eligibility Criteria: Inclusion Criteria: * Age greater than or equal to 18 years * Self-reported diagnosis of type 2 diabetes Exclusion Criteria: * Not diagnosed with type 2 diabetes * Diagnosed with type 1 diabetes * Known to be pregnant (Self Reported) * Receiving dialysis or having known renal compromise * Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm. * Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity) 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

NCT01346033

{ "NCT_ID" : "NCT01393223", "Brief_Title" : "Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome", "Official_title" : "A Single-Center, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Trial Comparing the Safety, Tolerability and Efficacy of LP-08 With Placebo in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)", "Conditions" : ["Interstitial Cystitis"], "Interventions" : ["Drug: Normal saline", "Drug: LP-08 20mg", "Drug: LP-08 80mg"], "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)" : "2015-07-21", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-06-14", "Study_Completion_Date(Actual)" : "2018-06-14}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-07-07", "First_Posted(Estimated)" : 2011-07-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-07-12", "Last_Update_Posted(Estimated)" : 2018-11-01", "Last_Verified" : 2018-10" } }}

#Study Description Brief Summary The purpose of this study is to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be employed, i.e. the measured outcomes will be subjects' improvements in quantitative and qualitative measures of the disease condition being assessed prior to and after LP-08 instillations at four and eight weeks follow-up visits Detailed Description This is a single-center, dose-ranging, placebo-controlled, double-blind, randomized study including male and female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) as determined by a physician using the current diagnostic criteria for IC/BPS. A total of 36 subjects will be enrolled at up to five (5) study sites in the U.S. Enrollment is expected to be completed within one year of initiating the study. The study is comprised of two parts. The first part of the study is a dose-ranging, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of LP-08 at 20 mg and 80 mg doses as compared with placebo. The second part of the study is an Open Label Extension study of the safety, tolerability and efficacy of LP-08 80 mg. Subjects randomized to the placebo control group must have completed the randomized portion study, including the eight week follow-up period, to be eligible for the Open Label Extension. #Intervention - DRUG : LP-08 80mg - Intravesical instillation of 80mg LP08 - DRUG : Normal saline - Intravesical instillation of normal saline - DRUG : LP-08 20mg - Intravesical instillation of 20mg LP08

#Eligibility Criteria: Inclusion Criteria: A patient is deemed suitable for inclusion in the study if the patient meets the following criteria: * Male or female at least 18 years * IC/BPS diagnosed by a health care provider based the following criteria: Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night time frequency, in the absence of proven urinary infection or other obvious pathology Have had IC/BPS symptoms for at least six months Score of >= 12 on the ICSI/PI at baseline Urinary frequency > 10 times a day by self-report and confirmed on baseline three-day voiding diary Have IC/BPS that in the judgment of the investigator has been stable in the previous 30 days IC/BPS-related pain defined as a score of > 3 cm and < 9 cm on the pain VAS where 0 is no pain and 10 is maximum pain * Have had inadequate clinical responses with conservative treatments, which may include one or more of the following: 1) timed voiding and behavioral modification therapy, 2) dietary restrictions, 3) stress reduction and/or 5) oral therapy with any of the following medications: Antidepressants Antihistamines Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Analgesics Pentosan polysulfate * Women of childbearing potential: have a negative urine pregnancy test at screening, and must agree to use an acceptable from of contraception (oral contraceptives, intrauterine or double barrier methods), as agreed to by the investigator, during the study period * Provide signed informed consent * Subject agrees to be available for the follow-up evaluations as required by the protocol Exclusion Criteria: Patients are excluded from enrollment in the study if any of the following are true: * Currently pregnant or breastfeeding, or plan to become pregnant during the course of the study * Have received investigational products or devices within 30 days prior to screening visit * Have received intravesical therapy or bladder hydrodistention within 30 days prior to screening visit. Intravesical instillations may include liquid or drug delivery devices, pentosan polysulfate sodium, lidocaine, steroid, heparin, chondroitin and any combination or additional formulation. * Have participated in IC/BPS research trial within 90 days prior to screening visit or has not returned to baseline if participated in IC/BPS research trial greater than 90 days prior to screening visit * Have received any of the following medication within 30 days of screening visit, unless such medications have been administered at a stable dose during this month and are expected to remain at a stable dose throughout the study: Antidepressants Antihistamines (use of antihistamines as needed for allergies is allowed) Anticonvulsants Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Pentosan polysulfate sodium Oral chondroitin * Have indicated use of > 70 mg of morphine equivalents of opioids per week to control their IC/BPS pain within 30 days prior to screening, or are expected to require this level of IC/BPS pain control during the study period * Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation). Bladder botulinum toxin injections within nine months prior to screening. * Sacral and/or pudendal nerve neuromodulation device (Interstim) within the last 6 months. Subjects would not be excluded if they had Interstim greater than 6 months ago and is on a stable setting within the past 90 days * Percutaneous Tibial Nerve Stimulation (PTNS) treatment within the past 90 days * Evidence of renal impairment (creatinine > two times the upper limit of normal at Visit 1), hepatic impairment (AST or ALT > three times the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases per investigator's judgment * Post-void residual (PVR) urine volume of > 150 mL at screening * Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which might confound the interpretation of the study results * Previously received intravesical liposomes * Urinary tract or prostatic infection in the past 90 days before study entry * Active genital herpes or vaginitis * Urethral diverticulum * Pelvic malignancy within the past five years * History of cyclophosphamide or chemical cystitis, or tuberculosis or pelvic radiation * History of bladder or prostate tumors (benign or malignant) * Uncontrolled diabetes * Has any condition that would preclude treatment due to contraindications and/or warnings in the product labeling 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

NCT01393223

{ "NCT_ID" : "NCT03000361", "Brief_Title" : "Motorized Spiral Colonoscopy Trial: A First Feasibility Trial", "Official_title" : "Motorized Spiral Colonoscopy Trial (MSCT): A First Feasibility Trial", "Conditions" : ["Colonoscopy", "Safety Issues", "Adenoma"], "Interventions" : ["Procedure: Motorized Spiral Colonoscopy"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-02-01", "Study_Completion_Date(Actual)" : "2017-02-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-12-15", "First_Posted(Estimated)" : 2016-12-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-12-19", "Last_Update_Posted(Estimated)" : 2017-08-01", "Last_Verified" : 2017-07" } }}

#Study Description Brief Summary The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines recommendations. All other clinically relevant quality parameters of standard colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study represents the first clinical evaluation of using a motorized spiral assisted endoscope for examination of the colon with potential advantages for patients in terms of effectiveness and convenience of colonoscopy. Detailed Description Colonoscopy has been widely accepted for the diagnosis and treatment of colon diseases. Properly performed, colonoscopy is generally safe, accurate, and well-tolerated. Diagnostic colonoscopy is the preferred method to evaluate the colon in most patients with large-bowel symptoms, iron deficiency anemia, abnormal results on radiographic studies of the colon, positive results on colorectal cancer (CRC) screening tests, post-polypectomy and post-cancer resection surveillance, and diagnosis and surveillance in inflammatory bowel disease. In addition, colonoscopy has been introduced for CRC screening in some Western countries e.g. in the United States and Germany. Recent trials showed that screening colonoscopy has a large potential for prevention and early detection of colorectal cancer. Diagnostic colonoscopy is usually combined with endoscopic resection of small and medium sized polyps and flat neoplastic lesions. Patients in whom larger lesions are detected at a diagnostic colonoscopy are usually rescheduled for therapeutic colonoscopy in an appropriate setting. Quality parameters for colonoscopy were recently reported. In terms of intraprocedural indicators a cecal intubation rate of ≥ 90% for all cases of colonoscopy is widely accepted. Even experienced endoscopists classify up to 10% of colonoscopies as difficult and intubation of the cecum may then be impossible. A recent study evaluated the efficacy and safety of repeating colonoscopy in 520 patients with prior incomplete colonoscopy. Reasons for failure to complete colonoscopy in referring institutions were 'looping/redundant colon' in 53.8% of the cases, 'sigmoid fixation/angulation' in 38.8%, 'both sigmoid angulation and looping colon' in 5.8% of the cases. Issues with sedation caused failures in 1.5% of the patients. Conventional colonoscopy can be difficult in particular in these anatomical variations because pushing the endoscope tends to form loops with limited or no advancement of the tip of the instrument. Techniques like alternating pushing and pulling the endoscope or external compression of the abdomen are used to overcome these limitations. Loop formation and stretching the colon with the adjacent mesenterium as well as external compression are inconvenient or even painful for the patient. In addition these maneuvers prolong the procedural duration. We recently compared the use of ultrathin colonoscopies with standard colonoscope in a randomized trial in terms of cecal intubation rate, level of sedation, amount of propofol needed for sedation, number of external compressions, pain score patient satisfaction and other parameters. The results indicate that these parameters can be well used for evaluation of a new technique of colonoscopy. Spiral assisted endoscopy is based on a completely different concept of advancing an endoscope by pleating of bowel on the instrumentation shaft by rotation. This technique has been widely used for antegrade enteroscopy. For this purpose a manually rotatable overtube is used through which a thin flexible enteroscope is inserted. The distal end of the overtube contains a raised spiral thread for pleating the small intestine over the overtube. By manually rotating the spiral element the bowel pleats onto the overtube, allowing the operator to access and visualize the more distal portions of the small intestine. Spiral assisted endoscopy has been also approved and evaluated for retrograde enteroscopy via the anal route. It promises advantage for intubation of the cecum and the terminal ileum by its principle of pleating at least parts of the colon with consecutive shortening and less loop formation. These effects should reduce the need for external compression and they may cause less pain for patients. In addition, the spiral should stabilize the position of the colonoscope which is advantageous for careful examination and targeted interventions. Spiral overtube-assisted colonoscopy achieved a success rate of cecal intubation in 92% of 24 patients in whom conventional colonoscopy had failed. However conventional spiral endoscopy is cumbersome to use and requires assistance by a second endoscopist for its appropriate use. The Novel Motorized Spiral Endoscope represents a new technology which offers all of the advantageous options of spiral-assisted endoscopy with a faster and less invasive approach. The system is similar to other currently marketed endoscopes in that it incorporates a flexible insertion tube, light source, digital imaging, and channels for passing accessories for sample collection or therapeutic interventions. The system is unique in that it incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft spiral-shaped 'fins', pleats the colon on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access into the colon. The system also includes a display monitor, a motor control unit, device to display measured motor current and signal torque, and a set of foot pedals. It is currently being evaluated in a prospective study in patients with indications for antegrade enteroscopy ('European Novel Motorized Spiral Endoscopy Trial (ENMSET)) in the two centers conducting this study. So far more than 60 patients were successfully examined without major adverse events. The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines recommendations. All other clinically relevant quality parameters of standard colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study represents the first clinical evaluation of using a motorized spiral assisted endoscope for examination of the colon with potential advantages for patients in terms of effectiveness and convenience of colonoscopy. #Intervention - PROCEDURE : Motorized Spiral Colonoscopy - For any pathological finding during colonoscopy standard endoscopic techniques, e.g. forceps biopsy, injection, endoscopic mucosal resection, argon plasma coagulation - Other Names : - standard endoscopic interventions (not experimental)

#Eligibility Criteria: Inclusion Criteria: * Screening for colorectal neoplasia * Surveillance after previous polypectomy/endoscopic mucosal resection (EMR) * Positive results on colorectal cancer (CRC) screening tests * Evaluation of clinical symptoms of non overt gastrointestinal bleeding * Indeterminate iron-deficiency anaemia * Chronic diarrhoea * Indeterminate large-bowel symptoms requiring evaluation for colorectal disease Exclusion Criteria: * Age under 18 years * Health status American Society of Anesthesiologists classification (ASA) level >= 3 * Pregnancy * Known coagulopathy (INR>=2.0, Platelets < 70/nl) * Anti-platelet agents or anticoagulants (other than aspirin) within last 7 days * History of chronic inflammatory bowel disease * Previously identified colorectal polyps/lesions with indication for endoscopic resection * Any medical contraindication to standard colonoscopy * Any prior abdominal surgery of the mid or lower gastrointestinal tract (except uncomplicated appendectomy) * Known or suspected bowel obstruction or stenosis * Known hemorrhoids 3rd degree * Suspected perforation of the GI tract * Inability to tolerate sedation for any reason * Absence of a signed informed consent 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

NCT03000361

{ "NCT_ID" : "NCT04993963", "Brief_Title" : "Prehabilitation and Heart Valve Surgery", "Official_title" : "Impact of Prehabilitation on the Quality of Recovery (QoR) After Heart Valve Surgery.", "Conditions" : ["Valvular Heart Disease"], "Interventions" : ["Other: Control Standard Group", "Other: Cycle Ergometery Training (Prehabilitation)"], "Location_Countries" : ["Pakistan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-02-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-08-15", "Study_Completion_Date(Actual)" : "2021-08-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-08-05", "First_Posted(Estimated)" : 2021-08-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-08-05", "Last_Update_Posted(Estimated)" : 2021-10-06", "Last_Verified" : 2021-09" } }}

#Study Description Brief Summary To evaluate the impact of prehabilitation on quality of recovery in heart valve surgery. To evaluate the effects of Mild to moderate valvular diseases with Newyork Heart Association (NYHA) grade I and II . Previous studies were designed to target on Coronary artery bypass graft surgery (CABGs) patients no specifically heart valve surgery patients was studied so this study cover this aspect as well so from the outcomes of this study we will determine the prehabilitation effects on valvular surgery patients. Detailed Description A review stated that ' the concept of prehabilitation has entered the forefront which encompasses multidisciplinary interventions to improve health and lessen the incidence of postoperative decline. In the previous study held in pre-operative assessment clinic between March 2016 and August 2016, evaluated that PREHAB programme for frail patients undergoing CABG or Valve surgery may be able to improve functional ability and reduce hospital length of stay for those patients undergoing cardiac surgery. previous other studies, parental study which is PREQUEL study recruitment started in July 2018 expect patient recruitment and 3 months of follow-up will be completed in June 2022 then their analysis will be done. To improve functional and enhance the resources and postoperative recovery, prehabilitation plays a very cardial role. In some studies, it has been noticed that preoperative improvement in physical fitness, improve functional capacity all this is the part of the model for improving post-surgery recovery, this could play a vital role. #Intervention - OTHER : Cycle Ergometery Training (Prehabilitation) - Interval training on cycle ergometer: between 40% and 60% Vo2max, perceived exertion \<13 on Borg scale 20-30 min/session/day (intermittent of exercise 2-3 mint, followed by 1-2 min of active recovery) Cool down (5 minutes) AROM +Body stretch - OTHER : Control Standard Group - Breathing exercise 15 Reps and Walk (10-15 minutes)

#Eligibility Criteria: Inclusion Criteria: * Patients awaiting heart valve surgery for repair or replacement * Both gender * Mild to moderate valvular diseases * NYHA grade I and II * Pre-frail to moderately frail patients with a CFS of 4 <= age <= 6 * Patients with an estimated 6 <= age <= 8 weeks of surgical waiting list time. * Able to perform 6MWT at baseline with RPE<13 Exclusion Criteria: * Patients with severe left ventricular obstructive disease (severe aortic or mitral stenosis and dynamic left ventricular outflow obstruction). * Patients with unstable or recently unstable cardiac syndrome * Other than valve surgeries e.g. CABG * Hospitalization for arrhythmias/ congestive heart failure Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT04993963

{ "NCT_ID" : "NCT02085460", "Brief_Title" : "A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer", "Official_title" : "A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer", "Conditions" : ["Head and Neck Cancer"], "Interventions" : ["Drug: 4% Rebamipide liquid", "Drug: Placebo", "Drug: 2% Rebamipide liquid"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-08", "Study_Completion_Date(Actual)" : "2015-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-03-11", "First_Submitted_that_Met_QC_Criteria" : 2021-03-11", "First_Posted(Estimated)" : 2014-03-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-03-11", "Last_Update_Posted(Estimated)" : 2021-10-18", "Last_Verified" : 2021-09" } }}

#Study Description Brief Summary To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide. #Intervention - DRUG : Placebo - DRUG : 2% Rebamipide liquid - DRUG : 4% Rebamipide liquid

#Eligibility Criteria: Inclusion Criteria: * Head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy. * Patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions. 1. Definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx 2. Postoperative therapy: oral cavity, oropharynx, hypopharynx, or larynx * Patients with no history of chemotherapy, radiotherapy, or chemoradiotherapy for head and neck cancer * Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Patients who are able to hold fluid in the mouth * Patients who are able to swallow the investigational medicinal product (IMP) * Patients expected to survive for at least 3 months * Patients who have given written informed consent in person * Patients who can stay at or visit the hospital for scheduled examinations and observations * Patients who are able to take contraceptive measures to avoid pregnancy of the patient or their partner from the time of informed consent until 4 weeks after completion of IMP administration Exclusion Criteria: * Patients with primary malignant tumors other than head and neck cancer. * Patients with symptomatic viral, bacterial, or fungal infection * Patients with serious renal impairment * Patients with distant metastasis * Patients with severe complications (uncontrolled cardiac disease, diabetes, hypertension, etc) * Patients with any of the following laboratory test results: 1. Neutrophil count: <1500 L 2. Platelet count: <75000 L 3. Hemoglobin: <10.0 g/L 4. Aspartate aminotransferase (AST): >3 times the upper limit of the reference value at the trial site 5. Alanine aminotransferase (ALT): >3 times the upper limit of the reference value at the trial site 6. Serum bilirubin: >1.5 times the upper limit of the reference value at the trial site 7. Serum albumin: <3.0 g/dL 8. Serum creatinine: >1.5 the upper limit of the reference value at the trial site 9. Creatinine clearance : <30 mL/min * Patients complicated with autoimmune disease * Patients requiring continuous systemic administration of glucocorticoid * Female patients who are pregnant or lactating, who may possibly be pregnant, or who wish to become pregnant * Patients who have participated in any other clinical trial within 4 weeks prior to initiation of chemoradiotherapy * Patients who have a history of drug allergy to rebamipide, cisplatin, or other platinum compounds * Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02085460

{ "NCT_ID" : "NCT03893357", "Brief_Title" : "Prevalence of Antiphospholipid Antibodies in the Hemodialysis Patients Population Within the CHU Brugmann Hospital", "Official_title" : "Retrospective Study of the Prevalence of Antiphospholipid Antibodies in the Population of Hemodialysis Patients at the CHU Brugmann Hospital", "Conditions" : ["Antiphospholipid Syndrome"], "Interventions" : ["Other: Data extraction from medical files"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-03-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-25", "Study_Completion_Date(Actual)" : "2019-07-25}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-03-26", "First_Posted(Estimated)" : 2019-03-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-03-27", "Last_Update_Posted(Estimated)" : 2020-01-27", "Last_Verified" : 2020-01" } }}

#Study Description Brief Summary In patients with a chronic renal disease at the terminal stage, extrarenal epuration is essential for the control of clinico-biological complications. Two extrarenal epuration techniques are currently available: peritoneal dialysis (using the peritoneal membrane of the patient) and hemodialysis, requiring the use of an external biocompatible membrane known as 'dialysis filter'. This technique requires a vascular access (arteriovenous fistula or dialysis catheter). The thrombosis of vascular accesses represents a major cause of morbidity and mortality in hemodialysis patients. Thrombosis are more frequent when using synthetic prosthetic arteriovenous fistula instead of native arteriovenous fistula. Antiphospholipid Syndrome (APLS) is a rare autoimmune disease characterized by arterial thrombosis, venous thrombosis and obstetrical complications such as as defined by the Sidney's criteria. In the general population, the presence of antiphospholipid antibodies is associated with an increased risk of thromboembolic events. In the nephrological population, this prevalence is higher in hemodialysis patients compared to patients on peritoneal dialysis or non-dialyzed patients. Up to 37% of hemodialysis patients are positive for antiphospholipid antibodies and this biology is associated with thrombotic events and vascular access thromboses. However, some studies do not report this association and there is currently no consensus in terms of the therapeutic management of these patients. Some factors influencing the positivity for antiphospholipid antibodies have been reported: smoking, age, the presence of a non-glomerular nephropathy, hypoalbuminaemia, the use of a central venous catheter for dialysis or the use of a non-biocompatible dialysis membrane. Taking into account the conflicting data from the literature, it seems important to study the respective role(s) of 3 types of antiphospholipid antibodies in the occurrence of thrombo- embolic events in patients undergoing dialysis within the CHU Brugmann Hospital. #Intervention - OTHER : Data extraction from medical files - Retrospective data extraction from the medical files

#Eligibility Criteria: Inclusion Criteria: * All patients undergoing dialysis within the CHU Brugmann Hospital Exclusion Criteria: * Mutation of factor V * Mutation G20210A of the prothrombin gene * Protein C deficiency * Protein S deficiency * Antithrombin III deficiency 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

NCT03893357

{ "NCT_ID" : "NCT03473522", "Brief_Title" : "Effects of tDCS Combined With Therapeutic Exercises in Patients With Parkinson's Disease.", "Official_title" : "Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercises in Patients With Parkinson's Disease: Randomized Clinical Trial", "Conditions" : ["Parkinson Disease"], "Interventions" : ["Device: tDCS", "Behavioral: Exercise Therapy"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-02-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-01", "Study_Completion_Date(Actual)" : "2021-01-15}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-02-07", "First_Posted(Estimated)" : 2018-03-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-03-20", "Last_Update_Posted(Estimated)" : 2021-05-03", "Last_Verified" : 2021-04" } }}

#Study Description Brief Summary Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Therapeutic exercises are widely employed in the attempt to delay or minimize disease progression, characterized by significant motor and sensory deficits. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (TDCs) as a complement to therapeutic exercises. However, few studies have investigated the effects of TDCs combined with therapeutic exercises in patients with Parkinson's disease. This study aims to investigate the effect of TDCs combined with therapeutic exercises in people with Parkinson's disease. Thirty patients will be randomized into two distinct groups to receive either TDCs(anodal) + therapeutic exercises or TDCs (sham) + therapeutic exercises for 24 sessions over a five-week period. The primary clinical outcome (balance) and secondary outcomes (functional capacity, quality of life and perception of overall effect) will be collected before treatment after two and five weeks at month 3 and month 6 after randomization. The data will be collected by a blind examiner to the treatment allocation. Detailed Description In this study, a randomized, double-blind, placebo-controlled experimental design will be used. The 30 participants will be randomized into two groups: (1) TDCs(anodal) + therapeutic exercises and (2) TDCs (sham) + therapeutic exercises. The treatment will be performed for 8 weeks, with three sessions per week, totaling 24 sessions of electrostimulation and therapeutic exercises. The primary variable (balance), secondary outcomes and other outcomes will be assessed before and after treatment. Follow-up of patients will be conducted at 8, 12 and 24 weeks after randomization. All evaluations will be performed by a single researcher who, like the patients, will not know which stimulation group will be participating. Patients diagnosed with Parkinson's who seek treatment at the Clinical School of Physiotherapy of the Federal University of Piauí will receive detailed instructions on the present study. The physiotherapist responsible for evaluations will explain the objectives of the study, possible treatments, eligibility criteria and potential risks arising from the application of brain stimulation and therapeutic exercises. Patients who agree to the conditions and sign the consent form may participate in the study. Participants who meet the eligibility criteria will be included in the study. #Intervention - DEVICE : tDCS - Transcranial direct current stimulation is a modulation technique of neuronal excitability which has very promising results in Parkinson's disease. In addition to the possibility of increasing the excitability of areas to tDCS, it can also facilitate the execution of the exercises by increasing the excitability of the primary motor cortex and changing the recruitment strategies of the motor units. - Other Names : - non invasive brain stimulation - BEHAVIORAL : Exercise Therapy - Therapeutic exercises will be based on the literature (O'Sullivan and Schmitz 2004, Klamroth et al 2016, Reynolds et al., 2016, Pérez et al 2016, Smania et al., 2010, Pastor et al., 1993, Traub et al., 1980, Schoneburg et al., 2013) Each session will be divided into warm-up exercises; balance and relaxation, with a duration of 50 minutes and a frequency of 3 times a week. Training progresses and intensifies every two weeks. The subjects will perform five repeated movements of each exercise, evolving according to the condition of each patient (according to the Hoehn and Yahr staging scale). - Other Names : - Physiotherapy

#Eligibility Criteria: Inclusion Criteria: * medical diagnosis of idiopathic Parkinson's disease present for at least 12 months, * spontaneous demand for treatment, * in clinical follow-up and pharmacological treatment by a responsible physician, * Parkinson's classification of 1.5 <= age <= 3 according to the Hoehn and Yahr scale, * absence of cardiovascular diseases and musculoskeletal, * signing of the free and informed consent form. Exclusion Criteria: * Use any associated orthopedic device to aid gait or balance control, * signs of severe dementia (evaluated by the Mini-Mental State Examination - MMSE), * diagnosis of other neurological disorders (including those of central and peripheral nature) * previous treatment with tDCS, * medical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants) * the use of pacemakers or other implanted devices. Sex : ALL Ages : - Minimum Age : 50 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03473522

{ "NCT_ID" : "NCT00338286", "Brief_Title" : "A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy", "Official_title" : "A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy", "Conditions" : ["Breast Cancer", "Neoplasm Metastasis"], "Interventions" : ["Other: Standard supportive care (packed RBC transfusion)", "Drug: epoetin alfa + packed RBC transfusion"], "Location_Countries" : ["Colombia", "United States", "Poland", "Romania", "Macedonia, The Former Yugoslav Republic of", "Hong Kong", "Taiwan", "South Africa", "Russian Federation", "Argentina", "Philippines", "Indonesia", "Ecuador", "Georgia", "Mexico", "Brazil", "India", "Ukraine", "Chile", "Malaysia", "Bulgaria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2006-03-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-07-07", "Study_Completion_Date(Actual)" : "2017-01-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2006-06-16", "First_Submitted_that_Met_QC_Criteria" : 2016-02-23", "First_Posted(Estimated)" : 2006-06-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2006-06-16", "Last_Update_Posted(Estimated)" : 2018-03-19", "Last_Verified" : 2018-02" } }}

#Study Description Brief Summary The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy. Detailed Description Anemia is a common complication of the treatment of metastatic breast cancer and is related to the effects of chemotherapy and to chronic disease itself. This is a randomized, open-label, multicenter, international study to further examine the safety of the study drug used with standard supportive care (i.e., packed RBC transfusions) compared to standard supportive care alone, when used to treat anemia associated with chemotherapy. This study will be done in subjects with metastatic breast cancer who are being or will be treated with first-line chemotherapy with standard dose schedules of taxane monotherapy, or a taxane plus trastuzumab, or an anthracycline plus either a taxane or cyclophosphamide. The study hypothesis is that epoetin alfa, when used as supportive anemia care, does not increase the risk of tumor progression or death. The study treatment will be compared to the control treatment by comparing progression-free survival, i.e., the number of months from the date a patient is randomized into the trial to the date of the first documented disease progression or death. In addition to their chemotherapy, half of the subjects will be assigned to receive study drug (epoetin alfa) and half of the subjects will be assigned to standard supportive care for anemia. Subjects treated with the study drug will receive standard supportive care (packed RBC transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first.The hypothesis is to test that epoetin alfa, when used as supportive anemia care, is non-inferior to control (standard supportive care alone), as measured by progression free survival (PFS). Patients treated with the study drug will receive standard supportive care (packed red blood cells (RBC) transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first. Dose adjustments (dose escalation, dose reduction, dose interruption, and dose resumption) of epoetin alfa will be based on hemoglobin (Hb) and confirm to prescribing information. #Intervention - OTHER : Standard supportive care (packed RBC transfusion) - Per doctor prescription - DRUG : epoetin alfa + packed RBC transfusion - 40,000 IU SC once a week.

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed (e.g., slide of tissue) breast cancer * HER2/NEU positive or negative * Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy * Received 1st and 2nd line chemotherapy * Hemoglobin (Hb) <= 11g/dL at the time of randomization * planned to receive at least 2 more cycles of chemotherapy * Life expectancy > 6 months * Eastern Cooperative Oncology Group score 0 or 1 * At least 18 years using effective birth control or surgically sterile or postmenopausal for 1 year Exclusion Criteria: * Active second cancer * no recent history of clinically relevant thrombovascular event * Current treatment with anticoagulants * Brain metastasis or CNS involvement * Anemia secondary to another cause * Recent (within prior 1 months) use of an ESA * Patient pregnant or breast feeding * Progressive disease during adjuvant/neoadjuvant chemotherapy * Rapidly progressive or life-threatening metastatic disease * Concomitant endocrine therapy * Patient in whom the only site of metastasis was local and was successfully treated surgically. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00338286

{ "NCT_ID" : "NCT03491241", "Brief_Title" : "Inflammatory Axis and Sirtuins' in Overweight Pre-diabetics Patients", "Official_title" : "Effect of Inflammatory Axis and Sirtuins' Expression in a Population of Overweight Pre-diabetics Patients From Metabolic Homeostasis Towards the Adipogonesis, and to Cardiac Redomelling.", "Conditions" : ["Pre-diabetes", "Obesity"], "Interventions" : ["Dietary Supplement: hypocaloric diet therapy"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-11-01", "Study_Completion_Date(Actual)" : "2018-01-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-03-22", "First_Posted(Estimated)" : 2018-04-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-04-05", "Last_Update_Posted(Estimated)" : 2020-12-01", "Last_Verified" : 2020-11" } }}

#Study Description Brief Summary In obese patients the superficial adipose tissue works as an endocrine active tissue to express different cytokines, and multiple molecular pathways implied in the cross talking with different part of the human body, such as the cardiovascular system. To date, adipocytes and adipose tissue-derived macrophages and adipose tissue synthesize, and secrete several cytokines, and sirtuins. In this setting, the excess of body fat is linked to heart contractile dysfunction. All these pathways are differently expressed in obese diabetic patients as compared to obese non diabetic patients. Intriguingly, in diabetic obese patients the hyper-expression of inflammatory cytokines is associated to a hypo-expression of sirtuins. Furthermore, microRNAs (miRs) as miR 195 and miR 27 could be implied in the regulation of this complex cellular and molecular axis.Therefore, this molecular pattern in diabetic obese patients may correlate to altered myocardial performance, and to the development of heart failure disease. In this study authors will evaluate at baseline by peripheral blood samples and by the abdominal fat tissue, and than at 12 months of follow-up by perupheral blood analysis, the expression of cytokines sirtuins and miR 195/27 comparing pre-diabetics obese patients vs. non pre-diabetics obese patients. Detailed Description In obese patients the visceral fat, and the superficial adipose tissue work as an endocrine active tissue to express different cytokines, and multiple molecular pathways implied in the cross talking with different part of the human body, such as the cardiovascular system. To date, adipocytes, and adipose tissue-derived macrophages and adipose tissue, synthesize and secrete several cytokines, like tumor necrosis factor (TNF)-5 and interleukin (IL)-6, and anti-apoptotic proteins, such as sirtuins. Sirtuins are NAD+-dependent deacetylase involved in the control of energy metabolism, adipocyte hypertrophy, and of different cardiac reparative, and rimodellative functions. Furthermore Sirtuins could cross talk with inflammatory/oxidative stress axis, and could be modulated by miR 195/27 expression. In this setting, the excess of body fat is linked to heart contractile dysfunction. It is intuitive to speculate that, all these pathways are differently expressed in obese diabetic patients as compared to obese non diabetic patients. Intriguingly, in diabetic obese patients the hyper-expression of inflammatory cytokines is associated to a hypo-expression of sirtuins, and over expression of miR 195 and miR 27. Therefore, this molecular pattern in diabetic obese patients may correlate to altered myocardial performance, and to the development of heart failure disease. Authors' study hypothesis is that, this complex altered bidirectional pattern between the inflammatory and apoptotic pathways axis may be due to a progressive increase in adipose tissue, produced by long-term alterations in energy balance. However, all these alterations may be measured in adipocytes as well as in adipose tissue derived macrophages, and by peripheral blood assay. Intriguingly, no data evaluated these pathways in pre-diabetics obese patients, and their possible correlation to cardiac function worsening, and to the development of heart failure disease. Actually, the pre-diabetic obese subjects represent a population of patients associated to higher risk to develop cardiovascular disease, myocardial dysfunction, and heart failure. In these patients a not clear indication exists about the right dietetic and/or drug treatment to control the hyperglycemia. However, there is discussion about the necessity or not to introduce hypoglycemic drug therapy added to a hypocaloric diet therapy to control the hyperglycemic overload. Therefore, the aim of the present study will be to evaluate at baseline the abdominal fat tissue expression of cytokines, sirtuins, miR 195 and miR 27 (by direct tissue biopsy) and by peripheral blood samples in pre-diabetics obese patients vs. non pre-diabetics obese patients. As second, during six and twelve months of follow up by peripheral blood samples analysis authors will evaluate the abdominal fat tissue expression of cytokines, miR 195 and miR 27 in pre-diabetics obese patients treated by hypocaloric diet-therapy as compared to pre-diabetics obese patients treated by hypocaloric diet-therapy plus metformine. At the end, authors will report their correlation to myocardial performance index (MPI) as an index of myocardial performance in pre-diabetics obese patients treated by hypocaloric diet-therapy as compared to pre-diabetics obese patients treated by hypocaloric diet-therapy plus metformine. Authors may speculate to observe a different cytokines, sirtuins, miR 195 and miR 27 expression at visceral fat and peripheral blood in pre-diabetics obese patients vs. non pre-diabetics obese patients. As second, authors may find that, hypoglycemic drug therapy may induce a down regulation of peripheral blood cytokines, a hyper expression of sirtuins, and a down regulation of miR 195 and miR 27 involved in the control of energy metabolism, and of adipocyte hypertrophy, and secondary implied in a better cardiac function at follow up. #Intervention - DIETARY_SUPPLEMENT : hypocaloric diet therapy - all patients will receive an hypocaloric diet, with low carboidrates (\<50%) overload.

#Eligibility Criteria: Inclusion Criteria: * body mass index > 30; * prediabetes; * normal glycemic blood profile; * both gender; * > 18 yearsand < 65 years. Exclusion Criteria: * body mass index < 30; * diabetes; * age < 18, and > 65 years. 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

NCT03491241

{ "NCT_ID" : "NCT01987986", "Brief_Title" : "A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy", "Official_title" : "A Phase 2, Double-blind and Placebo Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy", "Conditions" : ["Edematous Fibrosclerotic Panniculopathy (EFP)"], "Interventions" : ["Biological: Collagenase Clostridium Histolyticum", "Biological: Placebo"], "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)" : "2013-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-08", "Study_Completion_Date(Actual)" : "2014-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-10-30", "First_Submitted_that_Met_QC_Criteria" : 2017-05-31", "First_Posted(Estimated)" : 2013-11-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-11-13", "Last_Update_Posted(Estimated)" : 2017-10-05", "Last_Verified" : 2017-09" } }}

#Study Description Brief Summary To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women. Detailed Description The Phase 2a study is a randomized, double-blind multiple-dose study that is expected to enroll approximately 144 women between the ages of 18 and 45 in the United States. Treatment effectiveness will be evaluated by investigator and patient assessments, as well as 3-D photographic imaging techniques. Once the safety and local tolerability profile from the first stage has been found to be acceptable subjects will be enrolled in stage 2. After an interim safety and local tolerability review was completed of all subjects in stage 1, it was determined that enrollment in stage 2 is acceptable and has been initiated. #Intervention - BIOLOGICAL : Collagenase Clostridium Histolyticum - injectible intervention - Other Names : - AA4500, Xiaflex, Xiapex - BIOLOGICAL : Placebo

#Eligibility Criteria: Inclusion Criteria: * Be a female between 18 <= age <= 45 of age. * Have at least one well defined dimple that is at least 1 cm but not more than 2 cm along the long axis and that is evident when the subject is standing * Have a photonumeric cellulite severity scale (CSS) score between 6 and 12 * Have a Body Mass Index (BMI) >19 and <30 kg/m2, and intends to maintain stable body weight throughout the duration of the study * Be willing to apply appropriate sunscreen to the selected quadrant before each exposure to the sun while participating in the study * Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening. * Have a negative urine pregnancy test at screening and before injection of AA4500 and be using an effective contraception method (ie, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study. * Be willing and able to cooperate with the requirements of the study. * Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC). * Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English. Exclusion Criteria: * Thyroid disease, unless controlled with medication for >= 6 months * Uncontrolled diabetes mellitus, as determined by the investigator * Uncontrolled hypertension, as determined by the investigator * Vascular disorder (eg, phlebitis or varicose veins) in area to be treated * Lipedema or a lymphatic disorder * Cushing's disease and/or use of systemic corticosteroids * History of lower extremity thrombosis or post-thrombosis syndrome * Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis * Inflammation or active infection in area to be treated * Cutaneous alteration in area to be treated * Rash, eczema, psoriasis, or skin cancer in the area to be treated * History of keloidal scarring or abnormal wound healing * Coagulation disorder * Taking a medication for chronic anticoagulation (except for <= 150 mg aspirin daily) * Known active hepatitis A, B or C * Known immune deficiency disease or a positive test for human immunodeficiency virus (HIV) * Other significant conditions including body dysmorphic disorder, which in the investigator's opinion would make the subject unsuitable for enrollment in the study * Is menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the investigator * Has used any of the following for the treatment of EFP on the legs or buttock within the timelines identified below or intends to use any of the following at any time during the course of the study: * Liposuction on the side of the body selected for treatment during the 12-month period before injection of AA4500 * Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision) within the selected treatment quadrant during the 12-month period before injection of AA4500 * Endermologie or similar treatments within the selected treatment quadrant during the 6-months period before injection of AA4500 * Massage therapy within the selected treatment quadrant during the 3-month period before injection of AA4500 * Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the selected treatment quadrant during the 2-week period before injection of AA4500 * Has a tattoo located within 2 cm of the site of injection * Is presently nursing a baby or providing breast milk for a baby. * Intends to become pregnant during the study. * Intends to initiate an intensive sport or exercise program during the study. * Has received an investigational drug or treatment within 30 days before injection of AA4500. * Has a known systemic allergy to collagenase or any other excipient of AA4500. * Has received any collagenase treatments within 30 days before treatment. - 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: No

NCT01987986

{ "NCT_ID" : "NCT01989416", "Brief_Title" : "Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients", "Official_title" : "Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients", "Conditions" : ["Antibiotic Resistant Infection"], "Interventions" : ["Drug: Soap", "Drug: 2% chlorhexidine wipe"], "Location_Countries" : ["Thailand"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-01", "Study_Completion_Date(Actual)" : "2015-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-10-13", "First_Posted(Estimated)" : 2013-11-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-11-14", "Last_Update_Posted(Estimated)" : 2015-12-02", "Last_Verified" : 2015-11" } }}

#Study Description Brief Summary The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients. Detailed Description The purpose of this study is to evaluate the usefulness of bathing with chlorhexidine wipe to reduce the risks of multidrug resistant bacteria acquisition and hospital-acquired bloodstream infection among ICU patients #Intervention - DRUG : 2% chlorhexidine wipe - The ICU patients will be bathing with 2% chlorhexidine wipe - Other Names : - chlorhexidine wipe - DRUG : Soap - The ICU patients will be bathing with Soap - Other Names : - Control soap

#Eligibility Criteria: Inclusion Criteria: * Age > 18 years * Admission in critical care unit eg. ICU, respiratory care unit, Cardiac care unit with in 24 hours * Expected duration of critical care unit admission > 48 hours Exclusion Criteria: * History of chlorhexidine allergy Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 95 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01989416

{ "NCT_ID" : "NCT00869882", "Brief_Title" : "SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis", "Official_title" : "Comparison of 2 Surgical Approaches in the Treatment of Degenerative Spondylolysthesis: Posterolateral Fusion With Instrumentation (GPLI) Plus or Minus Transforaminal Lumbar Interbody Fusion (TLIF)", "Conditions" : ["Degenerative Spondylolisthesis"], "Interventions" : ["Procedure: Circumferential arthrodesis", "Procedure: Posterolateral fusion with instrumentation"], "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)" : "2009-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-11", "Study_Completion_Date(Actual)" : "2013-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-03-25", "First_Posted(Estimated)" : 2009-03-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-03-25", "Last_Update_Posted(Estimated)" : 2014-10-30", "Last_Verified" : 2014-10" } }}

#Study Description Brief Summary This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion. Detailed Description Degenerative spondylolisthesis is defined as the slip of one vertebra onto the other due to degenerative lesions; the L4-L5 intervertebral space is mainly involved. Mean age of symptomatic disease is about 60. Surgery is indicated in the presence of radiculalgia and/or neurological claudication and/or invalidating lombalgia, worsening neurological deficit, presence of sphincterian incontinence. Surgical treatment of degenerative spondylolisthesis usually consists in neural decompression followed by posterolateral fusion with instrumentation. In the literature, fusion rate is estimated to be 80% with GPLI and seems to be increased by interbody fusion, especially transforaminal lumbar interbody fusion which has the advantage of unilateral disc interspace route, and fusion rate over 90%. It seems that hypolordosis in the instrumented segments caused increased loading of the posterior column in the adjacent segments. These biomechanical effects may explain the degenerative changes at the junction level that have been observed as long-term consequences of lumbar fusion. In addition to fusion, segmental lordosis gain seems to be an important long-term prognostic factor. Segmental lordosis recovery (upper than 3° in order to take into account measurement variability), was never assessed after TLIF procedure nor compared to that after posterolateral fusion in controlled randomized clinical trials. The main objective of the study is the comparison of efficacy between circumferential fusion (TLIF plus GPLI) and GPLI alone as surgical treatment of degenerative spondylolisthesis in term of 'Success' rate, defined as fusion and at least 3-degree increase of segmental lordosis angle, 24 months after surgery. In this trial, included patients will be randomly assigned to undergo either posterolateral fusion with instrumentation (GPLI) or circumferential fusion with transforaminal lumbar interbody fusion (TLIF) combined to GPLI. In both arms, bone autograft will be performed using loose fragments obtained during neurological decompression. Six visits are planned during the study: pre-inclusion visit within 3 months before surgery, inclusion/randomisation on the day before surgery, 3 follow-up visits (2, 6, and 12 months after surgery) and an end of study visit 24 months after surgery (or at time of withdrawal if relevant). Hospital stay (about one week, on average) is planned after surgery. #Intervention - PROCEDURE : Circumferential arthrodesis - Patients are carefully positioned in the proned position and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs which can be performed at surgeon's demand during the whole surgery time. The preceding procedure is performed. In case of foraminal stenosis, decompression is performed at the same time as discal approach via the narrowest foramen. In addition to this, before preparation of bed for bone grafting, nerve roots are retracted and the disc nucleus is removed entirely, then endplate decortication is performed. The disc space is distracted. The most anterior part of the disc space is packed with cancellous bone. A cage packed with bone is inserted into the anterior portion of the interspace. According to cage location, bone graft could be inserted in the posterior portion of the interspace. Cage placement is radiologically checked. The end of the procedure is the same as for GPLI. - Other Names : - TLIF+GPLI - PROCEDURE : Posterolateral fusion with instrumentation - Patients are carefully positioned in pronation and submitted to a posterior surgical approach under general anaesthesia. Surgical levels are viewed laterally by mean of intraoperative radiographs performed at surgeon's demand during the whole surgery time. Pedicle screw instrumentation is performed, followed by posterior neural decompression depending on the type of stenosis: * Central stenosis: decompression is performed including medial facectomy, laminectomy; * Foraminal stenosis: foraminotomy is performed, while preserving a graft bed as large as possible; * Pure foraminal stenosis: spinal duct is not opened. Local bone is harvested from the lamina and the spinous process and carefully fragmented for autologous graft. Subperiosteal dissection is performed between the transverse processes and lateral aspects of the facet joints. Two rods are placed and locked on screws in maximum compression to optimize segmental lordosis. Bone autograft is placed into this bed. - Other Names : - GPLI

#Eligibility Criteria: Inclusion Criteria: * Adults aged less than 75, * Having been informed about clinical trial objectives and risk, * Covered by health insurance system, * Suffering from degenerative spondylolisthesis (whatever the grade and intervertebral disc height) needing one-level surgical fusion due to either invalidating lombalgia/radiculalgia despite 6-month optimal medical treatment and/or motor neurological symptoms. Exclusion Criteria: * Previous lumbar fusion, * Previous spine traumatism, * Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection). * Presence of at least one contraindication to either TLIF or GPLI, * Severe radiological osteoporosis. * Active cancer at time of inclusion into the study. * Unlikely to comply with the requirements of the study and/or to complete the study for psychological, social, familial or geographical reasons. * Under any administrative or legal supervision. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 74 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00869882

{ "NCT_ID" : "NCT04264819", "Brief_Title" : "Study of Brolucizumab in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration", "Official_title" : "A One-year, Single-arm, Open-label, Multicenter Study Assessing the Effect of Brolucizumab on Disease Control in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (SWIFT)", "Conditions" : ["Neovascular Age-Related Macular Degeneration"], "Interventions" : ["Drug: RTH258/Brolucizumab"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-12-14", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-05", "Study_Completion_Date(Actual)" : "2023-05-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-02-07", "First_Submitted_that_Met_QC_Criteria" : 2024-09-06", "First_Posted(Estimated)" : 2020-02-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-02-07", "Last_Update_Posted(Estimated)" : 2024-11-07", "Last_Verified" : 2024-09" } }}

#Study Description Brief Summary Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss. Detailed Description This is a prospective, single-arm, open-label, multicenter study to evaluate the efficacy and safety of brolucizumab 6 mg in pretreated suboptimal anatomically controlled patients with neovascular age-related macular degeneration (nAMD). #Intervention - DRUG : RTH258/Brolucizumab - Brolucizumab is a new generation of anti-VEGF (vascular endothelial growth factor). All patients will be treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by Treat-to-Control regimen up to Week 44/46.

#Eligibility Criteria: Inclusion Criteria: * Patients must provide written informed consent before any study-related procedures are performed. * Patients must be 50 years or older at Screening/Baseline. Study eye: * Active CNV lesions secondary to nAMD diagnosed < 18 months prior to Screening/Baseline that affect the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by FA and sequelae of CNV, e.g. pigment epithelial detachment (PED), subretinal hemorrhage or sub RPE hemorrhage, blocked fluorescence, or macular edema. * Previous treatment with only one licensed anti-VEGF drug (i.e. Lucentis®, Eylea®) with a >= Q4 and <= Q8 treatment (treatment interval of 26 to 62 days inclusive) with licensed anti-VEGF (a minimal washout period of at least 4 weeks / 26 days is required). Patients must have received at least 3 injections of this anti-VEGF in the 6 months prior to Screening/Baseline. * Presence of residual fluid (IRF or SRF that affects the central subfield under, as seen by OCT) * BCVA score must be <= 83 and >= 38 letters at an initial testing distance of 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at Screening/Baseline. Exclusion Criteria: Ocular conditions * Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis), in either eye at Screening/Baseline. * Presence of amblyopia, amaurosis, or ocular disorders in the fellow eye with BCVA < 35 ETDRS letters at Screening/Baseline (except when due to conditions whose surgery may improve visual acuity, e.g. cataract). * Medical history of intraocular inflammation and/or retinal vascular occlusion within 12 months prior to Screening/Baseline Study eye * Poor quality of OCT image at Screening/Baseline. * Atrophy or fibrosis involving the center of the fovea in the study eye, as assessed by CFP and fundus autofluorescence (FAF). * The total area of fibrosis or subretinal blood affecting the foveal center point comprising >= 50% of the lesion area in the study eye. * Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than nAMD, that, in the judgment of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product. * Structural damage within 0.5 disc diameter of the center of the macula in the study eye, e.g. vitreomacular traction, epiretinal membrane, RPE rip/tear scar, laser burn, at the time of Screening/Baseline that in the Investigator's opinion could preclude visual function improvement with treatment. * Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Screening/Baseline. * Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to the Investigator's judgment, at Screening/Baseline. * Aphakia and/or absence of the posterior capsule in the study eye. Ocular treatments (study eye) * Patient has received any investigational treatment for nAMD (other than vitamin supplements) in the study eye at any time. * Previous use of intraocular or periocular of corticosteroids in the study eye within the 6 month period prior to Screening/Baseline. * Previous penetrating keratoplasty or vitrectomy at any time prior to Screening/Baseline. * History or evidence of the following in the study eye within the 90-day period prior to Screening/Baseline: * Intraocular or refractive surgery. * Previous panretinal and peripheral laser photocoagulation. * Previous macular surgery or other intraocular surgical intervention * Previous laser treatment for nAMD including photodynamic therapy (PDT) laser at any time prior to Screening/Baseline. * Previous treatment with investigational drugs. Sex : ALL Ages : - Minimum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04264819

{ "NCT_ID" : "NCT02078999", "Brief_Title" : "Biomarkers in Patients Undergoing Mechanical Ventilation", "Official_title" : "Observational Study in Patients Admitted in the Intensive Care Unit.Tracheal Bacterial Load Surveillance in Patients Undergoing Mechanical Ventilation - Assessment of Biomarkers in the Distinction Between Colonization and Infection", "Conditions" : ["Ventilator Associated Pneumonia"], "Location_Countries" : ["Spain"], "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)" : "2010-09", "Study_Completion_Date(Actual)" : "2015-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-08-03", "First_Posted(Estimated)" : 2014-03-05" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-03-04", "Last_Update_Posted(Estimated)" : 2017-04-04", "Last_Verified" : 2017-04" } }}

#Study Description Brief Summary To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons and for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load, procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC), American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) consensus conference criteria, Sequential Organ Failure Assessment score (SOFA) and simplified Clinical Pulmonary Infection Score (CPIS) through the mechanical ventilation period Detailed Description The investigators hypotized that: 1. In patients on mechanical ventilation for a non-infectious cause of respiratory failure, the tracheal bacterial load should be absent or below the cut-off values defined for infection, that is to say tracheal colonization. 2. In patients without the diagnosis of Ventilator-Adquired Pneumonia (VAP) and not taking antibiotics till the weaning process, tracheal bacterial load should remain below the predefined cut-off values and the biomarkers (PCT and CRP) should be surrogate markers of this clinical course. 3. In patients developing VAP, an increase in tracheal bacterial load should precede diagnosis with an associated rise in the biomarkers levels (PCT and CRP). Finally, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as of the biomarkers (PCT and CRP). 4. In patients admitted with clinical suspicion of pneumonia, either community-acquired (CAP) or hospital-acquired (HAP), with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as the biomarkers (PCT and CRP). 5. In patients admitted with clinical suspicion of a non-pulmonary infection (e.g. peritonitis and urosepsis) and on mechanical ventilation for an expected length longer than 3 days, either community or hospital-acquired, preferentially with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease of biomarkers (PCT and CRP).

#Eligibility Criteria: Inclusion criteria: * Patients admitted in the ICU, with an expected length of mechanical ventilation > 3 days. * Not receiving antibiotics for >24 hrs before ICU admission- An expected length of mechanical ventilation > 3 days Exclusion Criteria: * Patients <18 yrs old * Pregnancy and lactation * Fulminant hepatic failure * Pancreatitis * Patients with the diagnosis of disseminated cancer, expected to die or undergo withdrawal of treatment within 72 hours after enrolment. 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

NCT02078999

{ "NCT_ID" : "NCT05469841", "Brief_Title" : "Pupillometry and Nociception Level Index for the Evaluation of Pain in Intensive Care Unit.", "Official_title" : "Pupillometry and Nociception Level Index (NOL-index) for the Evaluation of Pain in Intensive Care Unit. Prospective Study in Two Centers", "Conditions" : ["Critical Illness"], "Interventions" : ["Other: Systemic pain assessment"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-07-29", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-28", "Study_Completion_Date(Actual)" : "2023-03-28}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-06-20", "First_Posted(Estimated)" : 2022-07-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-07-19", "Last_Update_Posted(Estimated)" : 2023-04-03", "Last_Verified" : 2023-03" } }}

#Study Description Brief Summary Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible. Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillometry. Several studies in ICU showed a significant relationship between pupillary diameter variation and pain. The nociception level index (NOL-index) is a recent noninvasive and continuous monitoring of pain essentially used in operating room. The aim of this study is to evaluate the pupillometry and NOL index in critical ill patients in sedated patients under mechanical ventilation during the mobilization plus toilet (described in literature as not painful procedure) and tracheal suctioning (described as a painful procedure) Detailed Description Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception level index (NOL-index). The evaluation times will be 5 minutes before care procedures (mobilization plus toilet and tracheal suctioning), during the procedures (with the worst value recorded) and 5 minutes after the procedures. The procedures are: * A mobilization and toilet of the patient: a priori, not a very painful procedure. The pain will be evaluated every 5 minutes during the toilet. * Tracheal suctioning: a procedure known to be painful. The painful will be evaluated just at the end of tracheal suctioning (once the tracheal suctioning catheter is removed from the endotracheal intubation). #Intervention - OTHER : Systemic pain assessment - Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception Level Index (NOL) index.

#Eligibility Criteria: Inclusion Criteria: * older than18 years * Under invasive mechanical ventilation * Sedated with i) a Richmond Agitation Sedation Scale (RASS) : >= -4 and <1, ii) being unable to evaluate their pain by a visual numeric scale Exclusion Criteria: * Ophthalmological diseases which could modify the pupillometric parameters * Neurological diseases (damage of nerve III, intracranial hypertension, stroke) * Admitted in ICU after resuscitated cardiac arrest * Drugs that inhibit the effect of the sympathetic system (clonidine, dexmedetomidine) * Patient under Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) * Patient treated by a neuromuscular blockade * A do-not resuscitate order * Major hemodynamic instability prohibiting planned care procedures 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

NCT05469841

{ "NCT_ID" : "NCT01615198", "Brief_Title" : "Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension", "Official_title" : "A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension", "Conditions" : ["Essential Hypertension"], "Interventions" : ["Drug: Placebo", "Drug: LCZ696", "Drug: Olmesartan"], "Location_Countries" : ["Japan", "China", "Taiwan", "Thailand", "Hong Kong", "Philippines", "Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-07", "Study_Completion_Date(Actual)" : "2013-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-06-06", "First_Submitted_that_Met_QC_Criteria" : 2015-07-20", "First_Posted(Estimated)" : 2012-06-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-06-06", "Last_Update_Posted(Estimated)" : 2015-10-23", "Last_Verified" : 2015-10" } }}

#Study Description Brief Summary The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension. #Intervention - DRUG : Olmesartan - 10 mg, 20 mg, 40 mg capsules - DRUG : Placebo - Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule - DRUG : LCZ696 - 100 mg, 200 mg tablets

#Eligibility Criteria: Inclusion Criteria: * Patients must give written informed consent before any assessment is performed * Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure >= 150 mmHg and < 180 mmHg * Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance Exclusion criteria: * Patients with severe hypertension (msDBP >= 110 mmHg and/or msSBP >=180 mmHg). Patients with history of angioedema, drug-related or otherwise * Patients with history or evidence of a secondary form of hypertension * Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke * History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. * Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates). * Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication * Patients with previous or current diagnosis of heart failure (NYHA Class II-IV). * Patients with a clinically significant valvular heart disease at the time of screening * Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply Sex : ALL Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: No

NCT01615198

{ "NCT_ID" : "NCT04967703", "Brief_Title" : "Physiotherapy Protocols in Treating Plantar Fasciitis", "Official_title" : "Effect of Radial Shock Wave and Ultrasound Therapy Combined With Traditional Physical Therapy Exercises on Foot Function and Dorsiflexion Range in Plantar Fasciitis: A Prospective Randomized Clinical Trial", "Conditions" : ["Plantar Fascitis"], "Interventions" : ["Procedure: Group A", "Procedure: Group B", "Procedure: Group C"], "Location_Countries" : ["Saudi Arabia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-05-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-12-31", "Study_Completion_Date(Actual)" : "2022-03-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-07-07", "First_Posted(Estimated)" : 2021-07-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-07-15", "Last_Update_Posted(Estimated)" : 2023-05-23", "Last_Verified" : 2023-05" } }}

#Study Description Brief Summary This study aimed to investigate the efficacy of different physical therapy protocols in the treatment of chronic plantar fasciitis patients. Patients in this study were randomly assigned into 3 groups. Group A received ultrasound therapy protocol, group B received radial shock wave therapy protocol and group C received a combination of both ultrasound therapy and radial shock wave therapy protocol. All patients were also received a traditional physical therapy program. Foot function was evaluated by foot function index and ankle dorsiflexion range of motion was measured by Baseline® bubble inclinometer at the baseline and 4 weeks after treatment Detailed Description Sixty nine patients having unilateral chronic plantar fasciitis will be recruited for the study from Al-Qurayyat General Hospital, in Al-Jouf Region, Saudi Arabia. The inclusion criteria were as follows: patients suffered planter fasciitis of more than 3 months, maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning. Patients were excluded if they had previous ankle or foot surgery or pathology, or if they had a previous history of shock wave therapy or topical corticosteroid injections to the ankle or foot, circulatory disturbances in the lower extremities, neuropathic or radicular pain in the lower limbs. Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and gout, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study. The patients were randomly assigned into 3 equal groups (n = 23). Group A received ultrasound therapy protocol using Enraf Nonius Sonoplus 490, Netherlands. Group B received radial shock wave therapy protocol using Swiss DolorClast® Master, Electro Medical Systems, SA, Nyon, Switzerland. Group C received a combination of both ultrasound therapy and radial shock wave therapy protocol. All patients also received a traditional physical therapy program (3 sessions per week, for 4 weeks) consisting of Calf muscles stretching and plantar fascia stretching. Foot function and Ankle dorsiflexion range of motion were evaluated at the baseline and 4 weeks after treatment. #Intervention - PROCEDURE : Group A - Patients received ultrasound therapy protocol with the following parameters (1 MHz frequency, intensity of 1.5 W/cm2 and use of continuous mode of ultrasound for 5 minutes), in addition to a conventional physiotherapy program consisting of calf muscles stretching, plantar fascia stretch, strengthening exercises and manual massage for 3 sessions per week, for 4 weeks - Other Names : - Ultrasound therapy protocol - PROCEDURE : Group B - Patients received radial shock wave therapy protocol with the following parameters (1) the energy level was 0.12 mJ/mm2 equivalent to 2.5 bar intensity, (2) the number of shoots was 2000, (3) the frequency was 8 Hz, in addition to the same conventional physiotherapy program given for group A - Other Names : - Radial shock wave therapy protocol - PROCEDURE : Group C - Patients received both ultrasound and radial shock wave therapy, in addition to the same conventional physiotherapy program given for group A - Other Names : - Combined therapy protocol

#Eligibility Criteria: Inclusion Criteria: * Patients suffered plantar fasciitis of more than 3 months * Maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning Exclusion Criteria: * Bilateral plantar fasciitis * Previous ankle or foot surgery or pathology * If they had a previous history of shock wave therapy or topical corticosteroid injections to the ankle or foot * Circulatory disturbances in the lower extremities * Neuropathic or radicular pain in the lower limb * Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and gout, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study. Sex : ALL Ages : - Minimum Age : 25 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT04967703

{ "NCT_ID" : "NCT00153985", "Brief_Title" : "Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies", "Official_title" : "Multi-Center Study Using Allogeneic Stem Cell Transplantation Following Reduced Intensity Chemotherapy in Patients With Hemoglobinopathies", "Conditions" : ["Hemoglobinopathies", "Sickle Cell Disease", "Thalassemia"], "Location_Countries" : ["United States"], "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)" : "2004-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-03", "Study_Completion_Date(Actual)" : "2009-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2005-09-08", "First_Submitted_that_Met_QC_Criteria" : 2013-02-06", "First_Posted(Estimated)" : 2005-09-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2005-09-08", "Last_Update_Posted(Estimated)" : 2013-07-30", "Last_Verified" : 2013-07" } }}

#Study Description Brief Summary The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored. Detailed Description * In order to undergo transplant procedure, patients will be admitted to the hospital for approximately 10-14 days. * To prepare patient's bone marrow to accept donor stem cells, they will receive fludarabine and busulfex. Fludarabine will be given intravenously once daily for 4 days. Busulfex will be given once daily for the same 4 days. * One day before patients receive busulfex and fludarabine, they will also be given alemtuzumab intravenously once daily for 5 days. * Three days after the end of chemotherapy, patients will receive the infusion of donor stem cells. * If patients have thalassemia, they will receive subcutaneous injections of filgrastim starting on day one after the donor stem cell transfusion and will continue receiving filgrastim every day until it appears that the donor stem cells have been accepted. If the patient has sickle cell disease, filgrastim will not be given, * Additional drugs will be given to help prevent infection (i.e. antibiotics). * After stem cell infusion patients will be examined and have blood tests weekly for 1 month. Bone marrow biopsies, and blood work will also be performed 1 month, 3 months, 6 months and 1 year after stem cell infusion. * Patients will be on the study for about 12 months. After study is completed progress will be monitored on an annual basis. #Intervention - DRUG : Busulfex - Given once daily for 4 days - DRUG : Fludarabine - Given intravenously once daily for 4 days - DRUG : Alemtuzumab - One day before fludarabine and busulfex are started, alemtuzumab will be given once daily for 5 days. - Other Names : - CAMPATH - PROCEDURE : Stem Cell Transfusion - Performed three days after the end of chemotherapy

#Eligibility Criteria: Inclusion Criteria: * Patients with sickle cell disease should have one or more of the following: acute chest syndrome requiring hospitalization; nonhemorrhagic stroke or central nervous system event lasting longer than 24 hours; recurrent caso-occlusive pain or recurrent priapism; sickle neuropathy; bilateral proliferative retinopathy and major visual impairment of at least one eye; osteonecrosis of multiple joints; transfusion dependence; vaso-occlusive. * Patients with thalassemia should have one or more of the following: transfusion dependence; iron overload; presence of 2 or more alloantibodies against red cell antigens. Exclusion Criteria: * Pregnancy * Acute hepatitis * Cardiac ejection fraction < 30% * Severe renal impairment * Severe residual functional neurologic impairment * Evidence of HIV infection 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

NCT00153985

{ "NCT_ID" : "NCT01803061", "Brief_Title" : "Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care", "Official_title" : "Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care", "Conditions" : ["Head and Neck Cancer Patients", "Late Effects"], "Interventions" : ["Behavioral: WebCan"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-09", "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" : 2013-02-21", "First_Posted(Estimated)" : 2013-03-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-02-28", "Last_Update_Posted(Estimated)" : 2015-03-06", "Last_Verified" : 2015-03" } }}

#Study Description Brief Summary Patient-reported information on outcomes such as symptom-burden and health-related quality of life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer research. However, integrating patient-reported information in the routine clinical practice is often difficult due to excessive time use and practical barriers. Electronic data acquisitions, where the treating physician has immediately access to the patient-reported data in the subsequent consultation, have been shown to be beneficial in the everyday clinical decision making. The aim of this study is to develop and test a computer-based patient-reported assessment tool that will assist the clinicians in tracking long term and late effects in head and neck cancer patients and investigate if the tool leads to improved symptom assessment of a range of head and neck cancer specific symptoms, which again may lead to improved symptom control and enhanced quality of life in the patients. Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics at Herlev Hospital and physicians and nurses who work at the clinic will be invited to participate. The assessment tool will be developed with inspiration from prior international studies of symptom assessment in head and neck cancer patients and tailored so that it will fit into a Danish context. The tool will be tested in a controlled intervention study. In the intervention group, patients will complete the assessment tool in the patients waiting area prior to every scheduled consultation. The result will then be printed and provided to the treating physician. In the control group, the patients will complete the assessment tool prior to consultations. However, the data will not be provided to the physicians at any time. To assess the impact of the tool on number of symptoms addressed during consultations and patients' overall quality of life, medical records will be reviewed for before start of intervention and again at 6 and 12 months follow-up. The patients will also complete the EORTC QLQ-C30 and the EORTC QLQ-H\&N35 at baseline and at 6 and 12 months follow-up. Furthermore, we will conduct a qualitative evaluation (semi structured interview and participant observations) of attitudes among clinicians and patients regarding the use of tool at the point of care. #Intervention - BEHAVIORAL : WebCan - Provide computerized PRO (Patient Reported Outcome) to treating physician at the point of care to assess late effects after head and neck cancer

#Eligibility Criteria: Inclusion Criteria: * Prevalent recurrence free patients with cancers in the tongue, oral cavity, pharynx and larynx attending the oncology clinic at Herlev Hospital, Herlev, Denmark. 9 months to 5 years after end of treatment Exclusion Criteria: * Patients with recurrence of their cancers and patients still in treatment. Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT01803061

{ "NCT_ID" : "NCT03581981", "Brief_Title" : "Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD)", "Official_title" : "Improving Function Through Primary Care Treatment of PTSD", "Conditions" : ["Posttraumatic Stress Disorder"], "Interventions" : ["Behavioral: Treatment as Usual", "Behavioral: Prolonged Exposure for Primary Care (PE-PC)"], "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)" : "2019-04-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-09-12", "Study_Completion_Date(Actual)" : "2022-09-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-06-27", "First_Submitted_that_Met_QC_Criteria" : 2024-03-08", "First_Posted(Estimated)" : 2018-07-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-06-27", "Last_Update_Posted(Estimated)" : 2024-07-15", "Last_Verified" : 2024-03" } }}

#Study Description Brief Summary The proposed project will examine a promising brief therapy for posttraumatic stress Disorder (PTSD) for use in Veterans Health Administration (VHA) Primary Care and its impact on functional outcomes. This intervention will provide an alternative point of access to effective PTSD treatment and improved function that does not require referral to specialty mental health and accomplishes improved function in a short-term, brief protocol. Many Veterans prefer to receive mental health care, including PTSD service in primary care. The current protocol would allow them to access effective therapy options in addition to the medication management that is currently the standard of care for PTSD in primary care. In addition, this brief protocol may reduce the number of specialty mental health referrals as many Veterans may not require additional PTSD specific treatment after completion. Thus, if effective, this protocol will greatly increase Veteran treatment choice and improve functional outcomes and access while also increasing efficiency of allocation of specialty PTSD services. Detailed Description Posttraumatic stress disorder (PTSD) is a debilitating and costly mental health issue (Greenberg, Sisitsky et al. 1999, Hoge, Terhakopian et al. 2007). PTSD has an estimated two-year cost of $4.0 to $6.2 billion US dollars for mental health issues from the current conflicts in Iraq and Afghanistan and further estimated that providing evidence-based treatments for PTSD and depression could save an estimated $86.2 million (Tanielian, et al. 2008). Even modest reductions in PTSD severity have been related to increased probability of positive function outcomes (Smith, et al. 2005). Prolonged Exposure (PE) therapy (Foa, et al. 2000, Foa, et al. 2005, Schnurr, et al. 2007) is an effective, first-line treatment for PTSD (IOM 2007, VHA/Department of Defense (DOD) 2010). While highly effective, PE is provided in specialty mental health settings typically in 8 to 15, weekly 90 minute individual sessions. Veterans with PTSD are often reluctant to seek care in specialty mental health, and, as a result, many are treated solely in primary care and do not have access to this effective intervention (Possemato, et al. 2011). While the DOD and Veterans Administration (VA) have actively integrated behavioral health providers into their primary care clinics (Maguen, et al. 2010, Seal, et al. 2011), current behavioral interventions for PTSD in primary care are often inconsistent with clinical practice guidelines and/or not effective (Possemato, et al. 2011). Since functional outcomes are critical, the investigators intend to extend beyond assessing the impact of PE-PC on clinical outcomes to function. Thus, there is a clear and urgent need to further develop, validate, and disseminate evidence-based psychotherapeutic treatments for PTSD in integrated VHA Primary Care Mental Health Integration (PC-MHI) with a focus on functional outcomes. To fill this need and gap in care the study investigators developed a Brief Prolonged Exposure for Primary Care (PE-PC) treatment protocol with 4, 30-minute sessions for use in a stepped care model. A pilot study in military treatment facilities found PE-PC resulted in reductions in PTSD that were maintained at 6- and 12-month follow-up (Cigrang, et al, 2015). Preliminary results from a randomized controlled trial (RCT; PI: Cigrang; Co-Investigator: Rauch) of PE-PC compared to minimal attention control (MAC, including continuation of any PC initiated treatment) found a significantly larger reduction in PTSD severity (measured by PCL) in PE-PC than MAC (between group d = .78, p = .01). The strength of these initial findings is limited by lack of functional outcomes and examination of impact in VHA. While Service Members and Veterans have many similarities, potential differences in motivation for treatment and other factors may influence the efficacy of the protocol especially when examining changes in function. The proposed study will randomize 120 Veterans at Ralph H. Johnson Veterans Administration Medical Center (VAMC) presenting in primary care with PTSD who meet minimal inclusion/exclusion criteria to 6 weeks of PE-PC or PC-MHI-treatment as usual (TAU). Recruitment will occur over 36 months. All Veterans will complete a baseline assessment prior to randomization and post-treatment follow-up assessments at Weeks 6, 12, and 24 post-randomization. Primary outcome will be function assessed as self-reported role function in several domains. In addition, the investigators will examine symptoms severity and effectiveness, acceptability, and utilization associated with PE-PC or PCMHI-TAU in the 6 months prior to randomization and 6 months following treatment completion. PE-PC may allow access to effective treatment and efficient allocation of PTSD specialty treatment resources in the VHA. This topic is of key relevance to Veteran mental health care and can provide a new access point for high quality PTSD care to improve function allowing many more Veterans to experience improvement. #Intervention - BEHAVIORAL : Prolonged Exposure for Primary Care (PE-PC) - Brief version of Prolonged Exposure (PE) provided in 30 minute sessions in primary care (PC) - Other Names : - PE-PC - BEHAVIORAL : Treatment as Usual - Veterans assigned to Primary Care (PC) Mental Health Integration (PCMHI)-Treatment as Usual (TAU) will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU. - Other Names : - TAU

#Eligibility Criteria: Inclusion Criteria: * Any era Veterans seeking care in VA PC for PTSD symptoms [PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) of at least 28)] and PTSD confirmed based on Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) * English speaking * Report significant impairment in function related to PTSD symptoms as noted on intake World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) * Report that they want treatment for PTSD * If individuals are taking psychotropic medication, 2-weeks on stable dose will be required prior to enrollment Exclusion Criteria: * Other primary clinical issue that would interfere with PTSD treatment * Level of suicidal risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) that requires: * PTSD + interested and consent to study * Primary Care Provider (PCP) Screen: * Primary Care- Posttraumatic Stress Disorder Screen (PC-PTSD) + Intake * PCMHI Provider: * [PCL 28] + brief interview * No PTSD OR * Not interested in treatment OR * Not interested in study * Severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can adhere to the study regimen * Psychosis or unmanaged bipolar disorder * Moderate to severe substance use disorder in the past 8 weeks * Patients who are currently receiving talk therapy for trauma-related symptoms 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

NCT03581981

{ "NCT_ID" : "NCT02540785", "Brief_Title" : "Early Changes Between Lenticule Extraction and Small-Incision Lenticule Extraction", "Official_title" : "Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Between Lenticule Extraction and Small-Incision Lenticule Extraction", "Conditions" : ["Myopia", "Astigmatism"], "Interventions" : ["Procedure: lenticule extraction", "Procedure: small-incision lenticule extraction"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-12", "Study_Completion_Date(Actual)" : "2014-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-08-31", "First_Posted(Estimated)" : 2015-09-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-09-01", "Last_Update_Posted(Estimated)" : 2016-11-28", "Last_Verified" : 2016-11" } }}

#Study Description Brief Summary The aim is to evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE) procedures. Detailed Description The use of femtosecond (FS) laser has become one of the most significant technological advancements in refractive surgery. A breakthrough FS laser-assisted myopic and myopic astigmatic correction procedure can now be performed using a prototype femtosecond system. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE). In FLEx, a corneal flap is created by the FS laser (similar to LASIK) and lifted, allowing lenticule removal. For SMILE, a truly without flap procedure, only a small-2-4mm- incision is made, through which the lenticule is removed. Ocular surface disruption during corneal refractive surgery is commonly considered to be closely related to the development of dry eye. Multiple etiologies contribute to this ocular surface disruption, including the flap creation and stromal ablation involved in previous refractive surgery techniques. Corneal nerve damage has been considered the main cause of dry eye, due to disrupted afferent sensory nerves, reduced blink reflex, and increased tear evaporation leading to tear film instability. In addition, postoperative inflammatory mediator fluctuations are also a key factor related to ocular surface damage. Extensive research has described the effects of cytokines, chemokines and growth factors in modulating corneal wound healing, cell migration, and apoptosis on the ocular surface after refractive surgery. For both FLEx and SMILE, stromal ablation has been replaced by refractive lenticule removal. In terms of corneal flap formation, FLEx still requires an epithelial-stromal flap, while SMILE employs only a small incision to extract the lenticule. Hence, the investigators hypothesize that SMILE will have less effect on patients' ocular surface markers and inflammatory mediators, compared to FLEx. In support of this hypothesis, previous studies have reported that more damage to the sub-basal nerve plexus of the cornea and more changes in ocular surface evaluations were found after FLEx than after SMILE. In this study, the investigators have focused on postoperative changes to tear inflammatory mediators and the relationship of FLEx and SMILE to dry eye. #Intervention - PROCEDURE : lenticule extraction - Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction was released, the flap was opened using a thin, blunt spatula and the free refractive lenticule was subsequently grasped with a forceps and extracted, after which the flap was repositioned carefully - Other Names : - 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH) - PROCEDURE : small-incision lenticule extraction - Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), make a small incision - Other Names : - 0.3% tobramycin/dexamethasone (TobraDex, Alcon), 0.5% levofloxacin (Cravit, Santen), sodium hyaluronate (HYCOSAN,URSAPHARM Arzneimittel GmbH)

#Eligibility Criteria: Inclusion Criteria: * minimum age of 18 years(range from 18 year to 25 years); corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm; preoperative spherical equivalent refraction between * 2.00 diopter (D) and -6.50 D; preoperative cylindrical equivalent refraction between -0.25 D and -1.50 D; preoperative corneal curvature from 41.0 D to 46.0 D with a regular topographic pattern, verified with an Atlas topographer; monocular best corrected visual acuity of 20/20 or better and stable refractive error (less than 0.5 D change) for 24 months before surgery Exclusion Criteria: * systemic disease that contraindicated the surgery (such as diabetes, glaucoma and systemic collagen vascular disease); corneal abnormality or disease; a history of tear supplement usage or contact lens wear during the past year Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 25 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02540785

{ "NCT_ID" : "NCT01757353", "Brief_Title" : "Detroit Area Study of College Student Lifestyles", "Conditions" : ["Excessive Alcohol Consumption"], "Interventions" : ["Behavioral: BASICS motivational interview", "Behavioral: Self-directed: Information only", "Behavioral: BASICS plus normative enhancement motivational interview"], "Location_Countries" : ["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)" : "2014-07", "Study_Completion_Date(Actual)" : "2014-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-12-18", "First_Posted(Estimated)" : 2012-12-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-12-27", "Last_Update_Posted(Estimated)" : 2015-03-02", "Last_Verified" : 2015-02" } }}

#Study Description Brief Summary The goal of this research study is to compare three harm reduction approaches for at-risk college student drinkers. One approach provides generic risk-related information after an initial interview/questionnaire assessment session. A second approach uses an established motivational interviewing framework (Brief Alcohol Screening and Intervention for College Students; BASICS) that provides personalized feedback in a follow-up session. A third approach also uses BASICS, but tests the utility of a personality-informed module for this approach that is informed by the social investment hypothesis. Detailed Description While individual difference factors, such as trait self-control and subjective college student role investment, appear to be important predictors of excessive alcohol consumption and related problems, these factors are not typically incorporated into indicated prevention strategies. Indicated prevention usually focuses on groups or individuals who already express some aspects of a health-related problem (e.g., heavy episodic drinking), or who, at the very least, exhibit markers of risk (e.g., early age of first drink) associated with the development of a health-related problem (Gordon, 1987). The primary aim of the current proposal is to incorporate a personality-informed module into an existing motivational interviewing framework for alcohol-related harm reduction and test its efficacy compared to an information-only approach (i.e., informational packet) and a conventional strategy for indicated prevention (i.e., Brief Alcohol Screening and Intervention for College Students, BASICS; Dimeff et al., 1999) that has provided evidence for reduced risk of alcohol-related problems in randomized controlled trials (Borsari \& Carey, 2000; 2005). Motivational interviewing is a common technique used to address ambivalence and/or resistance to behavioral change. Motivational interviewing is commonly used in the context of health-related behaviors, such as excessive alcohol consumption, where an individual might not have experienced any serious consequences (e.g., driving while intoxicated), but may still be at risk for problems (Miller \& Rollnick, 2002). In motivational interviewing, a tone of collaboration and attentiveness is considered critical to the success of the interaction. The primary goal is to guide an individual toward increased motivation to change (and actual behavioral change) by being responsive to the desires and concerns of the individual as it relates to change, and by having an individual commit to even the most modest of change goals (e.g., consuming beverages with reduced alcohol by volume in situations that are known to be high-risk, rather than a favorite, higher alcohol-by-volume beverage). Motivational interviewing is well-suited to accommodate a personality-informed module for change due to its emphasis on an individual's unique profile of factors. In BASICS, a harm reduction approach is used to inform the assessment and content of the initial assessment session, as well as the follow-up feedback session (Dimeff et al., 1999). Consistent with research showing there to be a continuum of problems for alcohol and other externalizing behaviors (Bogg \& Finn, 2010; Krueger et al., 2002), the harm reduction approach emphasizes that any movement toward reduced risk and harm, regardless of its impact, is positive movement, even if a person might be farther along the continuum of harm (Marlatt, 1998). The current proposal seeks to test an augmentation of the harm reduction approach of BASICS with a normative enhancement approach derived from the social investment hypothesis of the Cumulative Continuity Model of personality development (Roberts \& Caspi, 2003). According to the social investment hypothesis, the process of commitment to normative roles, such as college student, is ''thought to exact a form of social control through the role demands embedded in these contexts that call on individuals to act with more responsibility and probity'' (Roberts \& Caspi, 2003; p. 203). To the extent that further commitment, investment, and involvement in the college student role can be fostered, then a concomitant increase in trait self-control should be expected as well, independent of harm reduction effects. As suggested by the findings described above, the effect of increased subjective college student role investment could be to deflect a risky trajectory for alcohol-related problems - an effect that could be further amplified by corresponding increases in trait self-control. This normative enhancement (NE) approach is posited to be particularly useful for those individuals who do not recognize or are steadfastly resistant to even minor harm reduction efforts conveyed through the motivational interviewing framework of BASICS. The strategy of the normative enhancement approach is to capitalize on an individual's goals for involvement in roles - especially those roles, such as college student, which are nominally voluntary in nature. #Intervention - BEHAVIORAL : BASICS motivational interview - BEHAVIORAL : BASICS plus normative enhancement motivational interview - BEHAVIORAL : Self-directed: Information only

#Eligibility Criteria: Inclusion Criteria: * We initially screen anonymously on the telephone for the inclusion/exclusion criteria (see attached phone screen). The responses obtained from respondents are used only to determine if they meet study criteria. Their names and responses are not recorded and the information they provide is shredded when the screen is completed. * be currently enrolled in full-time university coursework * be between the ages of 18 and 23 years * understand and be able to respond to screening questions in English * be able to read at a Grade 6 level * have consumed at least 4 (for women) or 5 (for men) standard drinks at least two times in the past 30 days OR typically consume at least 3 (for women) or 4 (for men) standard drinks on a drinking occasion * meet at least one of the DSM-IV diagnostic criteria for alcohol dependence OR score 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT Exclusion Criteria: * not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions) * not have any history of traumatic brain injury. Subjects also are excluded if they report a history of any serious head injury. * not have a history of psychotic symptoms or Bipolar Disorder * not be taking medications for cancer, AIDS treatment, or epilepsy * not be taking other medications that will affect behavior, such as major tranquilizers or antipsychotics * not currently receiving voluntary or mandated counseling or treatment for substance use Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 23 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT01757353

{ "NCT_ID" : "NCT00719875", "Brief_Title" : "HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer", "Official_title" : "A Dose-escalating and Phase II Clinical Trial of the Histone Deacetylase (HDAC) Inhibitor Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA, ZolinzaTM) in Combination With Capecitabine (XelodaTM) Using a New Weekly Dose Regimen for Advanced Breast Cancer", "Conditions" : ["Advanced Breast Cancer"], "Interventions" : ["Drug: Vorinostat"], "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)" : "2008-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-06", "Study_Completion_Date(Actual)" : "2013-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-07-18", "First_Posted(Estimated)" : 2008-07-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-07-18", "Last_Update_Posted(Estimated)" : 2017-03-03", "Last_Verified" : 2017-03" } }}

#Study Description Brief Summary The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST criteria. This study was originally intended to be a phase 1/phase 2. The protocol was amended to make this study a phase 1 only. #Intervention - DRUG : Vorinostat - BID days -7, 1-7 and 15-21, 200 mg - Other Names : - SAHA, Zolinza, HDAC inhibitor, suberoylanilide hydroxamic acid

#Eligibility Criteria: Inclusion Criteria: * Patients must have histologically confirmed advanced breast cancer * For the dose escalation phase: Patients must be refractory to standard therapy or for which no curative standard therapy exists, to be considered. * For the phase II: Patients with histologically confirmed metastatic breast cancer who have had no more than 2 prior chemotherapy regimens for treatment of their metastatic breast cancer. * Metastatic disease should not be progressing so as to require palliative treatment within 4 weeks of enrollment based on clinical assessment by the investigator. * Development of new lesions or an increase in preexisting lesions on bone scintigraphy, CT, MRI or by physical examination. Patients in whom the sole criterion for progression is an increase in a biochemical marker, e.g., carcinoembryonic antigen (CEA), or an increase in symptoms, are not eligible. * No radiotherapy, treatment with cytotoxic agents, or treatment with biologic agents within the 4 weeks prior to beginning treatment on this study (6 weeks for mitomycin or nitrosoureas). At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Patients must have fully recovered from the acute toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment <= grade 1 are eligible. * Age >=18 years. * ECOG performance status <=2 (Karnofsky >=60%, see Appendix A). * Life expectancy of greater than 3 months * Patients must have normal organ and marrow function as defined below: * leukocytes >=3,000/mcL * absolute neutrophil count >=1,500/mcL * platelets >=100,000/mcL * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal * creatinine within normal institutional limits OR * creatinine clearance >=60 mL/min/1.73 m² for patients with creatinine levels above institutional normal. * Women of child-bearing potential and men 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 treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients may not be receiving any other investigational agents. * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or capecitabine. * 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 would limit compliance with study requirements. * Women that are pregnant or breast-feeding are excluded from this study. * HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agents. * Patient had prior treatment with an HDAC inhibitor. Patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study. Patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period. 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

NCT00719875

{ "NCT_ID" : "NCT02403583", "Brief_Title" : "Jamii Bora: A Home-Based Couples Intervention", "Official_title" : "Jamii Bora: A Home-based Couples Intervention", "Conditions" : ["Human Immunodeficiency Virus"], "Interventions" : ["Behavioral: Intervention- Home Visits"], "Location_Countries" : ["Kenya"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-08-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-03-31", "Study_Completion_Date(Actual)" : "2017-03-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-02-24", "First_Posted(Estimated)" : 2015-03-31" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-03-25", "Last_Update_Posted(Estimated)" : 2017-04-06", "Last_Verified" : 2017-04" } }}

#Study Description Brief Summary The purpose of the study is to develop and pilot-test a home-based intervention to facilitate sate HIV testing and disclosure within pregnant couples in order to increase use of prevention-of-mother-to-child-transmission (PMTCT) and family health services in Kenya. Detailed Description Despite the potential for anti-retroviral therapy (ART) to ensure maternal health and reduce vertical HIV transmission to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. Prevention of mother-to-child transmission (PMTCT) requires a complex series of interventions throughout pregnancy and after birth, and only an estimated 15-30% of eligible women complete this 'PMTCT cascade'. Drop-offs can occur in the PMTCT cascade if women refuse HIV testing, do not disclose their HIV status, or avoid essential health services because they fear negative consequences for their relationship with their male partner. Engaging both partners of a couple during pregnancy has the potential to enhance health decisions, increase healthcare utilization, and ultimately improve maternal, paternal, and infant health. The goal of this study is to develop and pilot a home-based couples intervention that includes safe HIV testing and disclosure for couples, alongside information and counseling for family health during the perinatal period. The investigators will adapt existing evidence-based Couples HIV Counseling and Testing (CHCT) protocols for the special needs of pregnant women and their male partners, and train pairs of lay health workers (one female and one male) to deliver this service as part of home visits in rural Kenya. As men rarely attend antenatal clinics in Kenya, a home-based strategy can reach the couple in a safe and convenient space and give them unprecedented access to family health information, CHCT services, and linkage to care. This intervention, based on an interdependence model of communal coping and behavior change, is expected to help couples to communicate, plan, and take action around HIV and family health. Building on our team's preliminary studies in this rural Kenyan setting, the investigators collected further formative data and translated our findings into a viable intervention model with input from local stakeholders. The investigators will then conduct a pilot study of the home-based couples intervention, in which the investigators will randomize pregnant women at two antenatal clinics to the intervention or standard care arms of the study, and follow them and their male partners until three months after the expected delivery date of the baby. The investigators will preliminarily assess the effects of the intervention on uptake of CHCT by couples, repeat HIV testing during pregnancy for HIV-negative women, and utilization of PMTCT and HIV services for HIV-positive women and men. The investigators will also explore the roles of potential mediators for these effects suggested by our interdependence conceptual framework (such as measures of couple relationship dynamics). Results from this study will provide evidence of the preliminary impact, acceptability, and feasibility of the intervention and the study methods that will allow our team to develop a larger-scale efficacy trial. Engaging pregnant couples in family health and PMTCT is an essential step towards reducing HIV-related maternal mortality and eliminating new HIV infections among children in sub-Saharan Africa. #Intervention - BEHAVIORAL : Intervention- Home Visits - If a woman has been randomized to the intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the woman about optimal times for a home visit. The woman will be given a letter for her male partner to inform him about the study and potential upcoming visits, given that our preliminary research revealed that notifying the male partner beforehand is important. As described above, the intervention arm will consist of three home visits conducted by one female and one male lay health worker.

#Eligibility Criteria: Inclusion Criteria: * (a) 18 years or older (b) 36 weeks of pregnancy or less (c) has been offered HIV testing at ANC, (d) is currently in a stable relationship (married or cohabiting) with a male partner of duration of at least 6 months (e) is currently living with a male partner who will be in residence at least one night a week at the home during the study period, (f) has not yet participated in couple HIV counseling and testing during this pregnancy (g) has not disclosed current HIV status to male partner (h) does not know with certainty the HIV-positive status of her male partner. Exclusion Criteria: * (a) Currently pregnant (b) Greater than 36 weeks of pregnancy (c) < 18 years (d) Not currently in a stable relationship of at least 6 months (e) Does not currently live with male partner at least one night a week at the home (f) Has not been offered HIV testing (g) Has received CHCT with current male partner (h) has disclosed current HIV status to male partner (i) Knows with certainty current male partner is HIV-positive 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

NCT02403583

{ "NCT_ID" : "NCT02819258", "Brief_Title" : "Monocentric Study and Prognostic of Treatments Endodontics of Teeth With Periapical Pathology Realized CSERD (Nantes University Hospital)", "Official_title" : "Monocentric Study and Prognostic of Treatments Endodontics of Teeth With Periapical Pathology Realized CSERD (Nantes University Hospital)", "Conditions" : ["Dental Pulp Disorder"], "Interventions" : ["Other: Endodontic treatment"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-03", "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" : 2016-05-31", "First_Posted(Estimated)" : 2016-06-30" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-06-27", "Last_Update_Posted(Estimated)" : 2016-06-30", "Last_Verified" : 2016-05" } }}

#Study Description Brief Summary Endodontic therapy is to achieve the eviction of the inflamed or infected pulp and fill the canal opening with a hermetic sealing material. The analysis of the literature on intracanal therapeutic shows great variability of the results obtained, the reported success rate is 53 to 95%. This is explained by the difficulty of the surgical procedure, but also by the multiplicity of possible factors of failure, related practitioner, canal anatomy, the operating procedures, the preparation techniques and root canal filling. This success rate is variable depending on the presence or absence of periapical pathology before treatment: more than 85% for teeth treated without initial periapical pathology against only 62% for teeth with pathology before treatment. Furthermore, the literature review revealed two contradictory assumptions about the dominant factor failure in endodontics: the failure of the sealing canal system (bad level shutter) against the failure of the endovascular disinfection. Main hypothesis of the research objectives: The probability of success in a year endodontic treatments carried out according to the recommendations and the operating standards on teeth with periapical pathology is approximately 60%. The primary prognostic factors would be the existence of intracanal obstacles (stop calcification ...) responsible for a sub-obturation of the canal, factors inherent to the tooth (situation ductal anatomy and complexity), the operating techniques used, the practitioner ( skill level), the quality of the restoration. #Intervention - OTHER : Endodontic treatment

#Eligibility Criteria: Inclusion Criteria: * Patients aged at least 18 years * Patient receiving endodontic treatment for a tooth with a periapical pathology (Category IV of Baume) * Patients affiliated to a social security scheme or of such a regime, * Patients admitted to the CSERD, * Patients in good general health, * Patient compliant (see medical records: number of appointments not honored) * Patients with a fixed address and available by telephone, pledging to return a year after treatment at a follow-up consultation for clinical and radiographic examination, and prevent CSERD of any changes of address and telephone number. * Patients including French * Patients free of guardianship or trusteeship Exclusion Criteria: * Age between 0 and 18 * Tooth with a pulp pathology type Category III of Baume * Unspecified sheet in diagnosis * Patients with general contraindication against the endodontic treatment of teeth with periapical pathology (risk oslérien, immuno-depressed subjects, patients with prosthetic hip, knee). * No possibility of rubber dam during endodontic treatment. * Patient with latex allergy (contraindicating the installation of a dam and possibly endodontic obturation with gutta-percha) * Patients whose postoperative follow is deemed random by the investigator (cf. medical record: number of appointments not honored) * Patient not engaging to return for clinical and radiographic examination in a year * Patients with temporary housing or no fixed address: Living in a furnished accommodation or a hotel room, in a nursing home, in a home-type squat, Homeless * Patients not meeting all inclusion criteria 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

NCT02819258

{ "NCT_ID" : "NCT04014335", "Brief_Title" : "A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy", "Official_title" : "An Open-Label Phase 2a Clinical Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Subjects With Primary IgA Nephropathy", "Conditions" : ["Primary IgA Nephropathy"], "Interventions" : ["Drug: IONIS-FB-LRx"], "Location_Countries" : ["Singapore", "Australia", "New Zealand", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-12-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-02-08", "Study_Completion_Date(Actual)" : "2024-04-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-07-08", "First_Posted(Estimated)" : 2019-07-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-07-08", "Last_Update_Posted(Estimated)" : 2024-05-14", "Last_Verified" : 2024-05" } }}

#Study Description Brief Summary The purpose of this study is to evaluate the effectiveness and safety of IONIS-FB-LRx, an antisense inhibitor of complement factor B messenger ribonucleic acid (CFB mRNA), and to evaluate the effect of IONIS-FB-LRx on plasma factor B (FB) levels and serum AH50, CH50 activity in participants with primary immunoglobulin A (IgA) nephropathy. Detailed Description This is a Phase 2, single arm open-label clinical study in up to 25 participants that will consist of a screening period, a 24-week treatment period, an optional treatment extension period of up to an additional 48 weeks, and a 12- week post-treatment follow-up evaluation period. #Intervention - DRUG : IONIS-FB-LRx - Participants will receive IONIS-FB-LRx, by subcutaneous injection (SC) at Week 1 and every 4 weeks through Week 25. Optional 48-week Extension, with drug dosing continuing every 4 weeks.

#Eligibility Criteria: Inclusion Criteria * Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal OR use a highly effective method of birth control * Biopsy-proven primary immunoglobulin A (IgA) nephropathy * Hematuria * Proteinuria Exclusion Criteria * Clinically significant abnormalities in medical history (e.g., dementia, stroke, acute coronary syndrome, thrombocytopenia, or major surgery within 3 months of Screening) * Diagnosis of primary or secondary immunodeficiencies of B-lymphocyte function, splenectomy, or history of recurrent meningococcal disease * Active infection 30 days prior to study * Estimated glomerular filtration rate (eGFR) <= 40 milliliters per minute per 1.73 square meters (mL/min/1.73m^2) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) * Presence of another renal disease including, but not limited to, diabetes and/or diabetic nephropathy, thin basement membrane disease, Alport's disease, IgA Nephritis (Henoch-Schonlein purpura), lupus nephritis, Minimal Change Disease, post-infectious glomerulonephritis or any other cause of proteinuria or secondary IgA nephropathy (including, but not limited to Celiac disease, Crohn's disease, human immunodeficiency virus (HIV), liver cirrhosis) * History of renal transplant or another organ transplant * Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of investigational agent, whichever is longer * Administration of immunosuppressive/immunomodulatory medication 12 months prior to study drug administration, except for short-term treatments. * Other protocol-specified inclusion/exclusion criteria may apply 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

NCT04014335

{ "NCT_ID" : "NCT04074915", "Brief_Title" : "Effects of Herbal Mouth Rinse for Chronic Periodontitis", "Official_title" : "Effects of 1% Matricaria Chamomile Mouth Rinse for the Management of Chronic Periodontitis: a Double Blind Randomized, Placebo Controlled Clinical Trial", "Conditions" : ["Chronic Periodontitis"], "Interventions" : ["Other: Placebo mouth rinse", "Drug: Test group", "Drug: Chlorhexidine mouth rinse"], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-12-20", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-04-15", "Study_Completion_Date(Actual)" : "2019-04-15}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-08-28", "First_Posted(Estimated)" : 2019-08-30" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-08-28", "Last_Update_Posted(Estimated)" : 2019-09-04", "Last_Verified" : 2019-08" } }}

#Study Description Brief Summary This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month while clinical parameters \[plaque index (PI), gingival index (GI), sulcus bleeding index (SBI), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), stain index (SI)\] were evaluated at base line, 1 month, and 3 months. CFU was also evaluating at above said time periods. Detailed Description This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month.The primary outcome of this study was CAL, while PPD was the secondary outcome measure. A single clinician (AA) who was blinded to the groups assigned to the individuals, recorded all the parameters i.e. PI, GI, SBI, PPD, CAL, GR, SI at base line (prior to the treatment), 1 and 3 months after therapy. PPD, CAL and GR were recorded at the six sites per tooth in every tooth, except third molar, with a manual UNC-15 periodontal probe (Hu-Friedy, Leinmen, Germany) to the nearest millimeter. For recording of parameters at different time periods patients were instructed to refrain from any oral hygiene procedure for 8 hours prior to the evaluation. Staining of the six maxillary anterior teeth was assessed using the Lobene index. CFUs of P. ginigvalis, T. forsythia, and T. denticola were evaluated at baseline , 1 months, 3 months. #Intervention - OTHER : Placebo mouth rinse - Normal saline - Other Names : - NS - DRUG : Chlorhexidine mouth rinse - Chlorhexidine gluconate - Other Names : - CHX - DRUG : Test group - Chamomile mouth rinse - Other Names : - CMT

#Eligibility Criteria: Inclusion Criteria: * systemically healthy individuals of > 30 years with previously untreated generalized chronic periodontitis (defined by Armitage in 1999), * having minimum 15 teeth, * minimum of six teeth with at least one interproximal site with PPD between 5 <= age <= 7mm, * CAL between 5 <= age <= 10 mm, at least 30% of the sites with PPD and CAL >= 5 mm * presence of bleeding on probing (BOP). Exclusion Criteria: * was any systemic disease, * use of any medication in the previous 6 months, * subjects wearing partial removal prosthesis or orthodontic appliance, * allergy to ingredient used in the study, alcoholics, smokers or tobacoo users in any form, mentally retarded individual, pregnant or lactating females. Sex : ALL Ages : - Minimum Age : 30 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT04074915

{ "NCT_ID" : "NCT02744443", "Brief_Title" : "Leucine Supplementation in Young Subjects Undergoing Resistance Training", "Conditions" : ["Healthy Volunteers"], "Interventions" : ["Dietary Supplement: Placebo", "Dietary Supplement: Leucine"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-01", "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" : 2016-04-12", "First_Posted(Estimated)" : 2016-04-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-04-15", "Last_Update_Posted(Estimated)" : 2016-04-20", "Last_Verified" : 2016-04" } }}

#Study Description Brief Summary Leucine supplementation could be useful to support muscle anabolism. This study aims to investigate the effects of leucine supplementation on muscle mass and muscle strength in young subjects undergoing resistance training. #Intervention - DIETARY_SUPPLEMENT : Leucine - DIETARY_SUPPLEMENT : Placebo

#Eligibility Criteria: Inclusion Criteria: * training experience > 12 months * no previous use of anabolic steroids * no diagnosed diseases or injuries at the time of recruitment * one-maximum repetition strength (1-RM) in leg press >= 3.5 and <= 5.0 times the body weight Exclusion Criteria: * use of creatine or beta-alanine supplements for the last 3 months * use of protein or aminoacids supplements for the last 1 month * engagement in specific dietary restrictions * engagement in competitive sports Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02744443

{ "NCT_ID" : "NCT03730324", "Brief_Title" : "Predicting Prostate Biopsy Results With Biomarkers and mpMRI.", "Official_title" : "Developing a Multivariable Diagnostic Prediction Model for Prostate Biopsy Outcome Using Biomarkers and mpMRI as Prediction Variables in Biopsy naïve Men.", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Diagnostic Test: Urine and plasma biomarkes.", "Diagnostic Test: mpMRI"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-11-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-07-01", "Study_Completion_Date(Actual)" : "2022-06-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-08-21", "First_Posted(Estimated)" : 2018-11-05" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-11-02", "Last_Update_Posted(Estimated)" : 2023-03-23", "Last_Verified" : 2023-03" } }}

#Study Description Brief Summary Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To improve the overall detection of clinical significant PC, multiparametric magnetic resonance imaging (mpMRI) has emerged as a new technique that might be useful in selecting the appropriate patient for biopsy. Nevertheless, mpMRI fail to detect cancer in some circumstances and the exact role of mpMRI is undetermined. Currently, the majority of PC is diagnosed either incidentally or by unsystematic screening with prostate specific antigen (PSA). PSA suffers from being an organ specific, but cancer unspecific serum biomarker. PSA testing may neither rule out or confirm the presence of prostate cancer. Newer biomarkers have shown promise in curbing some of this sensitivity and specificity gap, but still needs refinement. In the present study, the investigators will use mpMRI and a new set of urine and plasma biomarkers in combination, prior to performing standard biopsies in order to develop a prediction model for the biopsy outcome. If proven successful the model would offer excellent risk stratification and possibly mitigating the need for biopsies. Detailed Description Background Prostate cancer (PC) remains a significant cause of morbidity and death among men in Denmark and the rest of the western world. Over 4,500 PC cases are diagnosed every year being the second most common malignancy among men in Denmark. With increasing life expectancy, the incidence of PC is projected to increase. Pivotal to the successful treatment of prostate cancer is establishing an early diagnosis. Localised PC is potentially curable and current curative treatment options have shown efficacy in reducing cancer related mortality. TRUS biopsies: Transrectal ultrasound guided prostate biopsies (TRUS biopsies) are conducted routinely for histopathological confirmation in cases of suspected PC. Indication for prostate biopsies include elevated Prostate Specific Antigen (PSA) levels or palpable tumour on digital rectal examination. TRUS biopsies is associated with morbidity in the form of infection, haematuria, rectal bleeding and discomfort. Some of these complications may require hospital admission and can be life threatening. Current standard biopsy regimes include 10 to 14 systemic biopsy cores taken from the peripheral zone of the prostate. The majority of PC involve the posterior peripheral zone of the prostate readily available for biopsies. The remaining PC are isolated to the transition-, central- and anterior zone of the prostate which are not routinely biopsied on systemic biopsies. Thus, anteriorly located cancers may not be sampled with routine investigations and TRUS biopsies may yield false negative results. As the biopsies are taken randomly throughout the gland, significant cancers located in the peripheral zone will in some cases be missed. Biomarkers and liquid biopsies: PSA testing has been widely adopted and more cancers are being detected in Denmark due to unsystematic screening with PSA. PSA is a glycoprotein of the human kallikrein family, and elevated serum concentrations are associated to PC. It is organ specific but not cancer specific, therefore other causes may elevate values, including benign prostatic hyperplasia, prostatitis, urinary tract infections and bladder outlet obstruction. To distinguish prostate cancer from other causes of PSA elevation and to confirm the diagnosis, TRUS biopsies are currently the standard diagnostic test. A range of novel biomarkers has been proposed to overcome the limitations of PSA's low specificity. Few of these biomarkers have been implemented in clinical practise. In a recently published study, Albitar et al, using a panel of urine and plasma biomarkers, where able to predict biopsy outcomes with a positive predictive value of 90% and negative predictive value of 89% tolerating some low grade cancers (Gleason score \< 7). This idea has been disseminated as liquid biopsies. mpMRI of the prostate: Multiparametric magnetic resonance imaging (mpMRI) of the prostate has emerged as a new technology with the ability to detect PC. Especially in the setting of previously negative TRUS biopsies, mpMRI can provide important additional information enabling targeting of biopsies towards suspected PC lesions. Nevertheless, a PC negative mpMRI may fail to detect cancers in 43% of cases and miss 16% of PCs classified as clinical significant. Thus a negative mpMRI will currently still mandate systemic biopsies. Therefore, novel approaches are needed to better direct biopsies and select patient for biopsies. Aim The aim of the current project is to study the following issues: Assessing the value of prebiopsy mpMRI combined with liquid biopsies in biopsy naive men in predicting biopsy results and possible deriving a diagnostic predictive model. Assessment of the performance of TRUS mpMRI fusion guided biopsies vs. systemic biopsies combined with liquid biopsies. Confirming the value of liquid biopsies and investigating its relation to tumour grade and volume. #Intervention - DIAGNOSTIC_TEST : mpMRI - Study subjects will undergo urine and plasma biomarker testing and mpMRI prior to biopsy - DIAGNOSTIC_TEST : Urine and plasma biomarkes. - Study subjects will undergo urine and plasma biomarker testing prior to standard biopsy

#Eligibility Criteria: Inclusion Criteria: * Able to provide informed written consent. * PSA < 20. * Referred for prostate biopsy. Exclusion Criteria:: * Previously diagnosed with prostate cancer. * Active use of anticoagulant (excluding platelet inhibitors) or other contraindication for prostate biopsies. * Previously undergone prostate biopsies. * Inability to undergo mpMRI scan (pacemaker , claustrophobia, impaired renal function, allergy towards contrast agent etc) * Any, previous or current, therapy for benign prostate hyperplasia including surgery or medical therapy (except alpha adrenal blockers). * They withdraw their consent. Sex : MALE 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

NCT03730324

{ "NCT_ID" : "NCT02337023", "Brief_Title" : "Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects", "Official_title" : "Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects", "Conditions" : ["Healthy Subjects", "Kleine-Levin Syndrome"], "Interventions" : ["Radiation: Brain scintigraphy with injection of Neurolite® (ECD)"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-05", "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" : 2014-12-05", "First_Posted(Estimated)" : 2015-01-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-01-08", "Last_Update_Posted(Estimated)" : 2015-07-21", "Last_Verified" : 2015-07" } }}

#Study Description Brief Summary The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy subjects. These results will be compared with data obtained out of episode in patients with Kleine-Levin syndrome (KLS). The investigators want to determine if brain functional imaging and cognitive abnormalities persist during asymptomatic period in a large series of patients with KLS, and to find predictors of these abnormalities. Detailed Description 3 steps in the protocol : * Brain ECD-SPECT (marking brain perfusion in relation to brain active/hypoactive area) superimposed on a template T1-weighted brain MRI. * Extensive cognitive tests of executive functions, verbal memory and fluency , visuospatial ability and memory, reasoning abilities: spontaneous memory complaint, Stroop Color Word Test, Trail Making Test A and B, Direct and Reverse Digit Span Test, Letter and Semantic Fluency Test, Free and Cued Selective Reminding Test, Rey-Osterrieth Complex Figure, Mini-Mental test, Progressive matrice of Raven (PM-38) * KLS-inventory and face to face interview of patients and parents by neurologist for patients. Modified KLS-inventory for healthy subjects. Main outcome : Number of patients with persisting hypoperfused brain area (compared to controls), location of these area, number of patients with at least -1SD in one cognitive domain Correlation between KLS severity (disease course, number of episode, mean duration of episodes, time incapacitated, number of symptoms) and brain perfusion and cognitive abnormalities #Intervention - RADIATION : Brain scintigraphy with injection of Neurolite® (ECD) - Brain scintigraphy with injection of Neurolite® (ECD) 1 injection

#Eligibility Criteria: Inclusion criteria : * Subjects males and females with more than 18 y.o, age and sex-matched with patients with Kleine-Levin Syndrome * with the same educational level and dominant hand than patients with Kleine-Levin Syndrome * without any brain disease or sleep disease (Epworth score < 11/24) known. * with social security * french language * for women : nonpregnant taking effective contraception Exclusion criteria : * Minor subjects * adults under protection * subjects with neurologic, psychiatric, somatic or sleep diseases and/or receiving a psychotropic medication interfering with the results. * subjects with history of seizures or loss of consciousness * subjects with excessive alcohol consumption (more than 3 doses /day) * subjects without any social security * subjects non fluent in french * for women : no effective contraception or lactation period 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

NCT02337023

{ "NCT_ID" : "NCT03584191", "Brief_Title" : "Awareness, Care & Treatment In Obesity Management - An International Observation", "Official_title" : "Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO)", "Conditions" : ["Obesity"], "Interventions" : ["Other: No treatment given"], "Location_Countries" : ["Israel", "Saudi Arabia", "Mexico", "United Arab Emirates", "United Kingdom", "Spain", "Australia", "Switzerland", "Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-06-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-10-10", "Study_Completion_Date(Actual)" : "2018-10-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-06-29", "First_Posted(Estimated)" : 2018-07-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-06-29", "Last_Update_Posted(Estimated)" : 2019-05-24", "Last_Verified" : 2019-05" } }}

#Study Description Brief Summary The purpose of this survey is to collect the data on perceptions, behaviours and awareness related to obesity and obesity management for People with Obesity (PwO) and Health Care Professionals (HCP) treating obesity. Data will be collected via online surveys among each of the respondent groups. The surveys are expected to take approximately 25 minutes to complete and will be unique for PwO and HCP. As a cross-sectional study, there will be no treatment of patients. #Intervention - OTHER : No treatment given - Completion of a survey

#Eligibility Criteria: Inclusion Criteria: - PEOPLE WITH OBESITY - Age at least 18 years, both males and females - On-line consent to participate in study - Lives in one of the participating countries: Italy, Spain, United Kingdom (UK), Brazil, Chile, Mexico, Australia, Israel, Saudi Arabia, United Arab Emirates (UAE), Japan, South Korea - Current Body Mass Index (BMI) (based on self-reported height and weight) greater than or equal to 30 kg/sqm in Italy, Spain, UK, Brazil, Chile, Mexico, Australia, Israel, Saudi Arabia, UAE; current BMI greater than or equal to 25 kg/sqm in Japan and South Korea - HEALTH CARE PROFESSIONALS - Physician - Specialty is NOT plastic surgeon, general surgeon, or bariatric surgeon - Practices in one of the participating countries: Italy, Spain, UK, Brazil, Chile, Mexico, Australia, Israel, Saudi Arabia, UAE, Japan, South Korea - In practice at least 2 years - Spends at least 70 percent of time in direct patient care - Has seen at least 100 patients in past month - Has seen at least 10 patients in past month needing weight management defined as: a patient with a BMI greater than or equal to 30 kg/sqm with or without comorbidities. (BMI greater than or equal to 25 kg/sqm in Japan and South Korea) Exclusion Criteria: - PEOPLE WITH OBESITY - Declines to provide income - Previous participation in this study. Participation is defined as having given online consent in this study - Declines to provide race / ethnicity (in applicable countries) - Currently pregnant - Participates in intense fitness or body building programs - Has had significant, unintentional weight loss (due to major injury, illness, etc.) in the past 6 months Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT03584191

{ "NCT_ID" : "NCT01166971", "Brief_Title" : "A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)", "Official_title" : "A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs", "Conditions" : ["Cataract"], "Interventions" : ["Device: Tecnis MF", "Device: ReSTOR +3"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-03", }, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-07-19", "First_Submitted_that_Met_QC_Criteria" : 2011-10-04", "First_Posted(Estimated)" : 2010-07-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-07-20", "Last_Update_Posted(Estimated)" : 2011-11-24", "Last_Verified" : 2011-11" } }}

#Study Description Brief Summary The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece. #Intervention - DEVICE : ReSTOR +3 - Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction - DEVICE : Tecnis MF - Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

#Eligibility Criteria: Inclusion Criteria: * diagnosed with bilateral cataracts * candidate for presbyopic lens Exclusion Criteria: * >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings * pre-existing conditions that could skew the results Sex : ALL Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01166971

{ "NCT_ID" : "NCT00502346", "Brief_Title" : "A Trial to Determine the Relative Effect of PM101 I.V. Versus Placebo on Hemodynamics in Healthy Adult Volunteers", "Official_title" : "A Randomized, Double-blind, Double-dummy, Placebo-controlled Trial to Determine the Relative Effect of PM101 I.V. Versus Placebo on Hemodynamics in Healthy Adult Volunteers", "Conditions" : ["Healthy"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-07-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-11-02", "Study_Completion_Date(Actual)" : "2007-11-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-07-10", "First_Posted(Estimated)" : 2007-07-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2007-07-16", "Last_Update_Posted(Estimated)" : 2017-09-08", "Last_Verified" : 2017-09" } }}

#Study Description Brief Summary The primary objective of the study is to compare the effect of PM101 I.V. administered as an immediate intravenous bolus versus placebo on systolic blood pressure. Secondary objectives include evaluation of change from baseline in heart rate and change from baseline to the lowest value in mean arterial pressure and diastolic pressure. #Intervention - DRUG : PM10

#Eligibility Criteria: Inclusion Criteria: * Be a healthy male or female 18 <= age <= 55 of age, inclusive. Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial and must have a negative serum pregnancy test at screening and upon check-in to the study facility. * Have a BMI within the range of 18 <= age <= 35 kg/m2. * Be able to communicate effectively with the study personnel. * Have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit or on admission to the clinic. * Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction (such as high grade AV block, bifascicular or trifascicular block), and a normal QTc interval (i.e., <= 450 msec for males and females). * Be a nonsmoker defined as not having smoked in the past 6 months. * Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication. Exclusion Criteria: * Known hypersensitivity or allergy to amiodarone, Captisol, Cordarone I.V. or its excipients. * Known hypersensitivity or allergy to iodine or radio-opaque dyes. * Women who are pregnant or breast feeding. * A history or presence of asthma or other pulmonary disease, thyroid disease (hypo- or hyperthyroidism), hepatitis or other liver disease. * Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk. * The presence of abnormal laboratory values which are considered clinically significant. * Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2). * Received an investigational drug within a period of 30 days prior to enrollment in the study. * Received any drug therapy within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion is extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism. However, women of childbearing potential may receive hormonal contraceptives and the investigator may waive short-term use of a medication, which is not specifically prohibited, if the use occurred more than 5 half-lives prior to the first dose of any study-related treatment. * Consumption of alcohol within 48 hours prior to dose administration or during any in-patient period. * A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates. * Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction. * Prior participation in a Prism Pharmaceuticals amiodarone study. * Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration. * History of severe respiratory failure, circulatory collapse, severe arterial hypotension, heart failure, cardiomyopathy, or sinus node disease. 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

NCT00502346

{ "NCT_ID" : "NCT04813146", "Brief_Title" : "Role of Synchronized Lifestyle Modification Program on Diabetic Neuropathy Taking Oral Hypoglycemics", "Official_title" : "Role of Synchronized Lifestyle Modification Program on Diabetic Peripheral Neuropathy Patients Taking Oral Hypoglycemics and GLP-1 Analogues", "Conditions" : ["Diabetic Neuropathies"], "Interventions" : ["Other: SLP along with Physiotherapy", "Other: Physiotherapy", "Other: SLP"], "Location_Countries" : ["Pakistan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-02-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-30", "Study_Completion_Date(Actual)" : "2022-01-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-02-02", "First_Posted(Estimated)" : 2021-03-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-03-21", "Last_Update_Posted(Estimated)" : 2024-11-20", "Last_Verified" : 2024-11" } }}

#Study Description Brief Summary The aim of this study is to determine the combined effect of SLP along with Physiotherapy in improving Type 2 DPN patients taking OHAs and GLP-1 analogues. Detailed Description Diabetes mellitus (DM) is a chronic metabolic disease defined by persistently increased blood glucose levels with fasting blood glucose ≥ 126 mg/dl, random plasma glucose ≥ 200mg/dl and HbA1c ≥ 6.5%. Diabetes has emerged as a great socioeconomic burden for the developing world. In 2017, globally, 451 million people were affected with diabetes. In Pakistan, the prevalence of type 2 diabetes is 16.98% which differs significantly with age, education, body mass index (BMI), obesity, family history and blood pressure. DM is classified into type 1 diabetes (T1D) and type 2 diabetes (T2D). T1D occurs due to an autoimmune pancreatic beta cell destruction with consequent insulin deficiency whereas T2D occurs due to predominantly insulin resistance with relative insulin deficiency or defective secretion. T2D cause serious and chronic microvascular and macrovascular complications. One of the most prevalent microvascular complication is diabetic peripheral neuropathy (DPN). DPN is defined as distal, symmetric sensorimotor polyneuropathy as a result of hyperglycemia and microangiopathy. It is a demyelinating disease of peripheral nerve fibers that manifests as parasthesias, impairment of sensations of vibration, proprioception, touch, pressure, pain and temperature. Risk factors of DPN are age, duration of diabetes, HbA1c \>7.0%, increased BMI, hyperlipidemia and hyperglycemia. Treatment of T2D is targeted towards good glycemic control that includes life style modifications i.e. diet and exercise, oral hypoglycemic agents (OHAs) and subcutaneous insulin administration. In life style modification, variety of exercises are recommended that help to slow the progression of peripheral neuropathy.These include; aerobic training, weight-bearing, static and dynamic balance training and strength training exercises which improve the gait speed, stride length and nerve conduction velocities (NCVs) of sensory and motor nerves while flexibility exercises improve the range-of-motion in ankle, hip and shoulder joints and keep them flexible. Importance of dietary modification is enhanced if it is synchronized with the circadian rhythm of the body. Therefore, Synchronized Lifestyle Modification Program (SLP) is a personalized, homeostasis restoring, liver centric lifestyle modification program that works through the correction of body clock rhythm. Lifestyle medicine is defined as the discipline of studying how daily habits and practices impact both on the prevention and treatment of disease. Its key aspects are: regular physical activity, proper nutrition, weight management, avoiding tobacco and a sound mental health. Lifestyle modification in diabetics is believed to enhance the function of pancreatic islet cells and induce glucose-stimulated insulin release.Regarding pharmacological treatment, following OHAs are used which are; biguanides, insulin secretagogues, alpha-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase-4 (DPP4) inhibitors and sodium glucose co-transporter-2 inhibitors. Now a days, an injectable agent i.e. Glucagon like peptide-1(GLP-1) receptor agonist is used with OHAs and is effective in decreasing blood glucose levels with a low risk of hypoglycemia in elderly patients. Limited data is available which supports the combined effect of Synchronized Lifestyle modification Program (SLP) and Physiotherapy in the progression of DPN in T2D patients taking OHAs and GLP-1. #Intervention - OTHER : SLP - Synchronization of dietary intake with circadian rhythm of the body - OTHER : SLP along with Physiotherapy - Synchronization of dietary intake along with Physiotherapy (aerobic, flexibility, resistance and balance exercises) - OTHER : Physiotherapy - Physiotherapy given only (aerobic, flexibility, resistance and balance exercises)

#Eligibility Criteria: Inclusion Criteria: * Gender includes both male and female * Patients between age group 40 <= age <= 75 years * Clinically diagnosed patients of Type 2 diabetes on OHAs and GLP-1 analogues * Diabetic patients with symptomatic peripheral neuropathy (Severity of DPN is associated with a physical examination score > 2.5 by using Michigan Neuropathy Screening Instrument (MNSI) with grades mild, moderate and severe) Exclusion Criteria: * Type 1 diabetic patients * Age < 40 years and > 75 years * Patients with any other co-morbidities (Heart, liver and kidney diseases) * Patients with neuropathies due to any other disease * Orthopaedic and surgical procedure of lower limbs * Patients with foot ulcers * Peripheral vascular diseases * Patients receiving any structured supervised physiotherapy * Pregnant females Sex : ALL Ages : - Minimum Age : 40 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04813146

{ "NCT_ID" : "NCT04501445", "Brief_Title" : "Psychological Symptoms and Families of COVID-19 Patients", "Official_title" : "Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients With COVID-19", "Conditions" : ["Family Members", "Post Intensive Care Unit Syndrome", "Post Traumatic Stress Disorder"], "Interventions" : ["Behavioral: Written Summary of Rounds"], "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)" : "2020-09-14", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-04-08", "Study_Completion_Date(Actual)" : "2021-07-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-08-04", "First_Submitted_that_Met_QC_Criteria" : 2022-07-05", "First_Posted(Estimated)" : 2020-08-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-08-05", "Last_Update_Posted(Estimated)" : 2023-04-27", "Last_Verified" : 2022-07" } }}

#Study Description Brief Summary Families of patients in Intensive Care Units (ICUs) are at increased risk for developing psychological symptoms that can last for months after the patient is discharged. These symptoms can have significant impact on both the patient and family member's quality of life. The investigators have found that families of patients admitted to the Rush University Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically significant psychological symptoms than families of patients admitted prior to the COVID-19 pandemic. The investigators suspect that this finding is due in part to the hospital-wide no visitation policy that altered our standard communication practices and may have prevented families from being active participants in the patient's medical care. The goals of this project are 1) to determine the prevalence of psychological disorders among families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU care that were associated with the development of psychological disorders among family members and 3) to pilot a program in which families with psychological disorders after ICU discharge receive therapy from mental health professionals. Detailed Description Part 1- Post-ICU discharge survey and Interview Upon enrollment in this post-ICU discharge follow-up study, the subject (surrogate of the ICU patient) will complete a survey dealing with the patient's course since Rush discharge 1. Is the patient still alive? 1. If deceased, did the patient pass away at Rush or after discharge from Rush? 2. If alive, is the patient at home? i. If at home, for how long? Is he/she receiving home health services? 2. If the patient did not pass away at Rush, did the patient spend time in a rehabilitation hospital, nursing home, or long-term acute care hospital after discharge from Rush? 3. Is the patient currently having any of the following symptoms (check all that apply). 1. Fatigue 2. Trouble Breathing 3. Difficulty speaking 4. Difficulty eating 5. Difficulty thinking or paying attention 6. Pain or discomfort 7. Anxiety 8. Depressed mood 9. Difficulty moving or walking 10. Difficulty performing activities of daily living such as dressing or bathing 4. Have the subject used mental health services since the time the patient was admitted? 5. What is the subject's overall impression of mental health services (choices ranging from very unhelpful to very helpful) Subjects will be asked to complete the 1) Critical Care Family Needs Inventory (CCFNI) questionnaire, 2) Hospital Anxiety and Depression Scale (HADS), and 3) Impact of Events Scale Revised (IES-R) questionnaire. Subjects will participate in a 30-minute phone interview with a member of the study team. The interviewer will review the subject's responses to the above surveys and ask follow-up questions. The interviewer will ask how the subject has been coping with any psychological symptoms (i.e. anxiety, depression, post-traumatic stress) The psychologist will describe different types of interventions for people coping psychological symptoms and assess the subject's interest in pursuing any of them. Part 2 - Post-ICU psychological intervention Subjects with clinically significant psychologist symptoms based on either their survey or interview responses will be invited to participate in 6-week trauma-focused intervention with a psychologist. The program will be brief and delivered online to test the acceptability and feasible of the program, and to gather a preliminary estimate of effect size. We will pilot a group-based intervention (n =3-5) online over Zoom and deliver the intervention across six sessions outlined below. Sessions will last 60-75 minutes depending on participant questions and discussion. Experiential exercises will be drawn from Acceptance and Commitment Therapy, a related contemporary cognitive behavioral treatment (Hayes, Strosahl, \& Wilson, 2012). Some commentary of Viktor Frankl's (1985) work on meaning making will be made in group discussion. Activity scheduling worksheets from Martell, Dimijian and Herman-Dunn (2013) will be used for out of session homework. We plan two phases for the study. The first phase, sessions 1-3, focus on introducing the model of behavioral activation and guide the participants to identify activities that will being pleasant, meaningful, or offer a sense of accomplishment and mastery. The first session aims to normalize diverse responses to health-related stress and loss by introducing the behavioral model of depression, and the rationale for behavioral activation. In the second session participants then clarify their values, so that they can begin scheduling pleasant and/or meaningful activities in the third session. These activities are tailored based on each participant's individuals goals, priorities and values. The second phase, sessions 4-6, aims to reinforce and sustain positive gains made via behavioral activation and pleasant activity scheduling. Session 4 offers suggestions for problem-solving ways to overcome unhelpful avoidance, a transdiagnostic vulnerability that sustains a number of emotional and psychiatric disorders. Session 5 offers suggestions for overcoming rumination including instruction in mindfulness, and attentional techniques that help participants attend to the outcomes and experiences of the pleasant activities they engage in. Session 6 concludes the program, and guides participants to consider plans to maintain commitment to pleasant activities. Session 1 Psychoeducation Introductions. Question to group: Why are we here? * Normalize the grieving process and the challenges of COVID safety guidelines * grief, boredom, loneliness * 1/3 of USA adults report depression and anxiety * Discuss the behavioral model of depression - loss of reward and meaningful events as a prelude to negative moods of all types * Behavioral Activation as a strategy to enhance reward and meaning * Experiential: Contemplate a time in life when you felt you were doing well. How were you engaging the world around you? * Homework: Start Activity tracking. Worksheets will be provided, but we allow a more feasible approach of jotting down 1-2 words about activity and providing a subjective mood rating. Session 2 Value Clarification Question to the group: How do we bring purpose into our living? * Consider values as the foundation of meaning and purpose * Discuss meaning in life and Dr. Viktor Frankl's thesis that humans are driven to find meaning o 'We do not ask life what the meaning of life is. Life asks us, what is the meaning of your life. And life demands our answer.' * What gives/gave meaning to your loved one's life? What would make them smile? If you share values with this person, how can you honor those values you share in your own commitments and activities? * Experiential: Contemplate your 80th Birthday, Retirement Speech, family remembering you far in the future, etc, Homework: Values Compass. Participants will complete the values compass worksheet in which they rate their perceived importance and engagement in various domains of living (e.g, family life, learning, spirituality). Session 3 Scheduling Activities Question to group: What does it mean to be committed? * Discuss a role model or mentor who demonstrated commitment to something important. How did they do it? Do they share values with the patient they care(d) for? How do these * Selecting and scheduling pleasant events. Regardless of how you feel, take action to experience: * Pleasure * Mastery * Purpose * Health habits: steady sleep, diet, exercise * Experiential: Participants visualize, write or discuss steps needed to engage a plan. Visualize yourself overcoming a roadblock or barrier. * Homework: Activity Schedule. Participants will schedule several pleasant/meaningful events for the coming week. They will rate their mood while engaged in these activities and journal about their experiences. Session 4 Overcoming Avoidance What do we do with fear? * Getting out of the TRAP (Trigger-Response-Avoidance Pattern) to get on Track (Trigger Response Adaptive Coping) * Often we hurt when something that matters is threatened. We should protect what matters not the momentary feeling. Discuss 'fear as an arrow' that can be useful for pointing to ones values (e.g., we typically do not fear losing things we do not care about). * Experiential: Flipping the coins of avoidance. Participants look to how fears, and frustrations relate to other prosocial and personally valued events and experiences. * Homework: Activity Schedule. This repeats the homework from the prior week. Session 5 Working with thoughts Question to the group: How do we prevent going on autopilot so we stay focused on what matters? * Staying present to notice when actions are working. Being better at tracking outcomes. * Mindfulness versus rumination * Experiential: Mindfulness of the present. Participants are guided in a mindfulness exercise to attend to sense experiences in the present moment. The goal of the exercise is to introduce a skill for re-orienting to the present moment. This is particularly needed for attending to and noticing the pleasant and meaningful experiences that come from behavioral activation. * Homework: Activity Schedule Session 6 Recap and review Question to the group: How do we carry these lessons with us? How do we share these lessons with others? * The goal of this session is to review and to provide additional practice with any of the prior skills discussed in previous sessions. * Relapse prevention concepts will be discussed. Participants will be encouraged to continue to maintain pleasant activity scheduling, and to consider how these activities can be reinforced through social commitments, and daily reflection. * Consider making a symbol. Picture, photo, card, note to self to remind oneself of a valued activity. This can be displayed in a prominent place (e.g., family photo on the mantle, photo of exercise on bathroom mirror, religious text on coffee table). Should evoke pleasant memory, and motivation. Prior to beginning the intervention and at the completion of the intervention, surrogates will complete the 1) Hospital Anxiety and Depression Scale (HADS), and 2) Impact of Events Scale Revised (IES-R) questionnaire. At the completion of the intervention, subjects will participate in another 30-minute phone interview with a study investigator. The study investigator will review the subject's responses to the above surveys and ask follow-up questions. The study investigator will ask how the subject has been coping with any psychological symptoms (i.e. anxiety, depression, post-traumatic stress). All interviews will be audio recorded and transcribed. Two members study staff will review the transcriptions and use thematic content analysis to determine the types of psychological symptoms that are present and the reason(s) they may be present. When analyzing subject responses, the investigators will account for the following variables * Whether the patient is deceased or not * Length of time since hospital discharge * Whether the subject received mental health services on their own or not * Whether the subject received daily written summaries in the ICU or not Statistical Analysis The investigators expect \~100 subjects to meet inclusion criteria. The investigators expect \~70-100 to complete Part 1 (Post-ICU discharge survey and Interview). The investigators will determine the prevalence of psychological symptoms and opinions on ICU care by reviewing survey responses and interview recordings. The investigators expect \~30 to complete Part 2 (Post-ICU discharge survey and Interview). The investigators compare pre- to post-intervention survey responses for each subject using a paired t-test. Part 2 will be considered a pilot study. The investigators will use the results to plan a future, adequately powered study. #Intervention - BEHAVIORAL : Written Summary of Rounds - The summary was organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.

#Eligibility Criteria: Inclusion Criteria: * The patient's surrogate was enrolled in 'ICU Rounding Summaries for Families of Critically Ill Patients' (NCT03969810) and the patient had COVID-19 * The patient has been discharged from the hospital Exclusion Criteria: * None 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

NCT04501445

{ "NCT_ID" : "NCT00570336", "Brief_Title" : "Study of CTS-1027 in Hepatitis C Patients", "Official_title" : "A Dose Response Study of CTS-1027 in Hepatitis C Patients", "Conditions" : ["Chronic Hepatitis C Virus Infection"], "Interventions" : ["Other: Placebo", "Drug: CTS-1027"], "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)" : "2007-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-07", "Study_Completion_Date(Actual)" : "2009-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-12-06", "First_Posted(Estimated)" : 2007-12-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2007-12-06", "Last_Update_Posted(Estimated)" : 2010-09-16", "Last_Verified" : 2010-09" } }}

#Study Description Brief Summary The purpose of this study is to determine if CTS-1027 can lower elevated liver enzymes in patients with chronic HCV infection. Detailed Description Randomized, placebo-controlled, double-blind, parallel group, multicenter, dose response trial utilizing four doses of CTS-1027, administered orally once daily, in outpatients with chronic hepatitis C virus (HCV) infection. #Intervention - DRUG : CTS-1027 - Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd (quaque die, once daily). - OTHER : Placebo - Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd.

#Eligibility Criteria: Inclusion Criteria: * Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the trial * A history of chronic HCV infection * Unsuccessful HCV treatment defined as one or more of the following criteria: 1. Failure to achieve a virologic response during previous therapy, or 2. Failure to tolerate therapy, or 3. Failure to maintain a sustained virologic response, or 4. In the opinion of the Principal Investigator, the patient is not a suitable candidate for interferon based therapy * Liver impairment, as defined by either aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels 1.5 - 7 x ULN on at least two occasions, seven or more days apart, during the baseline period * Alpha-fetoprotein (AFP) <= 50 ng/mL * Hemoglobin >= 10 g/dL, platelet count >= 75 x 109/L, and white blood cell count >= 1.5 x 109/L * Willingness to utilize adequate contraception (if female, evidenced by being postmenopausal for at least 6 months or using contraceptive pill; for both females and males, being surgically sterile, or using two forms of barrier contraception) from screening to at least one month after the completion of the trial. Exclusion Criteria: * Decompensated or severe liver disease defined by one or more of the following criteria: 1. Prior liver biopsy showing cirrhosis 2. Prior liver biopsy showing bridging fibrosis (Metavir >2 or Ishak >3) more than 2 years ago in the absence of newer liver biopsy results 3. Prothrombin time: 3 seconds > control 4. Total bilirubin >= 1.5 x Upper limit of the normal range (ULN), or > 3 x ULN for unconjugated bilirubin 5. Serum albumin below normal limits 6. AST or ALT > 7 x ULN during baseline period 7. Evidence of portal hypertension including: * Splenomegaly or evidence of portal hypertension (i.e., enlarged portal vein and varices) on ultrasound, * Varices in esophagogastroduodenoscopy (EGD); or * Ascites * Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques) * Known history or presence of human immunodeficiency virus (HIV) infection * Co-infection with hepatitis B virus (HBV) * If female: pregnant, lactating, or positive serum or urine pregnancy test * Last baseline AST and ALT level prior to Day 1 of < 1.5 x ULN * Renal impairment (creatinine > 1.5 x ULN) or hepatorenal syndrome * Pancreatitis * Hospitalization for liver disease within 60 days of screening * Use of concomitant or prior drug therapy for HCV at screening, including the use of: 1. drugs with presumed anti-HCV activity in the prior three months 2. corticosteroids in the past 30 days 3. potentially hepatotoxic drugs in the past 30 days (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin) * Use of illicit or drugs of abuse in the prior three months (allowed if medically prescribed or indicated) * History of alcohol abuse within the past year * History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose QT or QTc interval of > 450 milliseconds * Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for ten or more years * Any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial. 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

NCT00570336

{ "NCT_ID" : "NCT01703195", "Brief_Title" : "Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina", "Official_title" : "Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina", "Conditions" : ["Vaginal Cancer"], "Interventions" : ["Procedure: Diffusion Weighted Magnetic Resonance Imaging (DWMR)", "Procedure: Magnetic Resonance Imaging (MRI)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-09-19", "Study_Completion_Date(Actual)" : "2019-09-19}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-10-05", "First_Posted(Estimated)" : 2012-10-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-10-09", "Last_Update_Posted(Estimated)" : 2019-09-23", "Last_Verified" : 2019-09" } }}

#Study Description Brief Summary The goal of this clinical research study is to learn if a type of MRI scan called diffusion weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want to learn if DWI can predict how tumors will respond to radiation therapy. Detailed Description If you agree to take part in this study, information will be collected from your medical record including your age, sex, and status of the disease. For the MRI scans, you will receive a routine contrast drug by vein. Contrast drugs are used by doctors in order to see MRI images more clearly. A modified MRI scan will performed right after your scheduled standard-of-care MRI scan. This modified MRI scan is the investigational scan. To complete the modified MRI scan, you will need to stay in the MRI scanner for about 8 extra minutes. It should take about 47 minutes total to complete both scans. The way that researchers program the MRI machine and the order in which the images are taken is what is being modified for the investigational scan. These changes may help researchers capture better images. Length of Study: Your participation on this study will be over after the modified MRI scan is complete. This is an investigational study. The standard-of-care MRI scan method is FDA approved and commercially available for the diagnosis of several diseases. The modified MRI scan method is being used in research only. Up to 25 participants will be enrolled in this study. All will take part at MD Anderson. #Intervention - PROCEDURE : Magnetic Resonance Imaging (MRI) - Magnetic Resonance Imaging (MRI) obtained pre-treatment and 4-6 weeks post-treatment. - Other Names : - MRI - PROCEDURE : Diffusion Weighted Magnetic Resonance Imaging (DWMR) - Diffusion Weighted Magnetic Resonance Imaging (DWMR) obtained pre-treatment and 4-6 weeks post-treatment. - Other Names : - DWMR

#Eligibility Criteria: Inclusion Criteria: * All patients who have gynecologic malignancies involving the middle third and the distal third of the vagina who will be receiving radiation therapy * Patients who have gynecologic malignancies involving the upper, middle and/or lower third of the vagina or are undergoing pelvic exenteration. Exclusion Criteria: * Pregnant patients * Any implantable medical device that is not MRI compatible (e.g. pacemakers, defibrillators, pain pumps or insulin pumps) 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

NCT01703195

{ "NCT_ID" : "NCT05128981", "Brief_Title" : "Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction", "Official_title" : "Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction", "Conditions" : ["Myocardial Infarction", "Cardiac Anxiety", "CBT", "Exposure"], "Interventions" : ["Behavioral: MI-CBT"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-10-28", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-10", "Study_Completion_Date(Actual)" : "2022-12-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-11-10", "First_Posted(Estimated)" : 2021-11-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-11-10", "Last_Update_Posted(Estimated)" : 2023-01-10", "Last_Verified" : 2023-01" } }}

#Study Description Brief Summary Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. The purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (Q oL) in patients following MI Detailed Description The study will include 30 patients. The MI-specific CBT lasts for 8 weeks and is therapist guided and delivered via internet via a secure digital platform by licensed psychologists expertise in CBT for cardiac disease or final year psychologist under supervision. During treatment, the psychologists will have direct access to a cardiologist assigned to the project and treatments are conducted in close interdisciplinary collaboration to ensure patient safety #Intervention - BEHAVIORAL : MI-CBT - Education of MI and common reactions, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention

#Eligibility Criteria: Inclusion Criteria: ( - )MI >= 6 months before assessment ( - )Age 18 <= age <= 75 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (Cardiac Anxiety Questionnaire (CAQ); score >=20) ( - ) On optimal medical treatment ( - )Able to read and write in Swedish. Exclusion Criteria: ( - ) heart failure with severe systolic dysfunction (ejection fraction <= 35%) ( - ) significant valvular disease ( - ) planned coronary artery bypass surgery or other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency 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

NCT05128981