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{ "NCT_ID" : "NCT04411810", "Brief_Title" : "SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer", "Official_title" : "SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer", "Conditions" : ["Skin Cancer"], "Interventions" : ["Device: Nevisense 3.0", "Procedure: Skin biopsy", "Device: Dermlite Cam", "Device: Barco Demetra"], "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)" : "2020-08-20", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-03", "Study_Completion_Date(Actual)" : "2023-03-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-05-28", "First_Submitted_that_Met_QC_Criteria" : 2024-04-03", "First_Posted(Estimated)" : 2020-06-02" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-06-01", "Last_Update_Posted(Estimated)" : 2024-04-08", "Last_Verified" : 2024-04" } }}

#Study Description Brief Summary The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. If successful, the widespread availability of such services would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. With decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma mortality. Detailed Description This is a prospective pilot study of a store-and-forward telemedicine diagnostic assessment of participant-selected skin lesions concerning for skin cancer, controlled against an in-person dermatologist assessment (gold standard evaluation). The study will be a single arm design with each participant undergoing telemedicine data acquisition (i.e. clinical and dermoscopic imaging and Nevisense measurement), immediately followed by the in-person dermatologist assessment. The in-person dermatologist will be blinded to the Nevisense score at the time of the visit. Using the telemedicine data, the teledermatology team will render a biopsy/no-biopsy recommendation within 3 business days of the participant evaluation. They will be blinded to the results of the in-person dermatologist's diagnostic evaluation. #Intervention - DEVICE : Nevisense 3.0 - Nevisense, an AI-based point-of-care system for the non-invasive evaluation of irregular moles remains the only FDA approved system available for melanoma detection in the US. Nevisense 3.0 will be used as a one-time exposure of \<8 seconds per lesion. Disposable electrodes that contact the participant are 5mm x 5mm in size. Nevisense 3.0 measures electrical impedance of skin lesions and provides an output called the electrical impedence spectroscopy (EIS) score. Electrical impedance is a measure of a material's overall resistance to the flow of alternating electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal tissue. - DEVICE : Dermlite Cam - Dermlite Cam is a digital camera that captures images of the skin under cross-polarized and non-polarized light and is 510(k) exempt. The DermLite Cam device appears as a single piece camera with a charging cable and USB computer cable. As part of the camera unit, an extensor arm exists to allow for the capture of standardized clinical images. The DermLite Cam will be used to acquire 3 images of \<5 seconds per lesion (one clinical, one polarized dermoscopic, and one non-polarized dermoscopic). NOTE - for the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam. - PROCEDURE : Skin biopsy - A skin biopsy is a small procedure that removes a sample of skin from the surface of the body. The method utilized will be either a shave or punch technique. The maximum size of a punch biopsy will be 6mm and these wounds are generally closed with no more than 2-3 sutures. A skin biopsy takes \<15 minutes including preparation time, administration of intradermal anesthesia using lidocaine 1% with epinephrine 1:100,000, removal of the skin sample, achievement of hemostasis, dressing the wound, and providing instructions for home care. Samples will be placed formalin for routine processing. - DEVICE : Barco Demetra - Barco Demetra is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin which can then be stored, retrieved, displayed, and reviewed by medical practitioners. The Barco Demetra received 510(k) Premarket approval (K192829). The system involves a hardware imaging device and a stand-alone software application. The hardware device is a portable, battery-powered medical device for acquiring and visualizing images of the skin and uploads all images to cloud storage. The software application is cloud software with an associated web application; it can be used to visualize images and related data and can generate consultation reports. For the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam.

#Eligibility Criteria: Inclusion Criteria: * Be 18 years or older * Have 1 <= age <= 3 lesions for evaluation Exclusion Criteria: * Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear 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: Yes

NCT04411810

{ "NCT_ID" : "NCT00511849", "Brief_Title" : "Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors", "Official_title" : "Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies", "Conditions" : ["Neoplasms"], "Interventions" : ["Drug: carboplatin + SU011248 (sunitinib) + paclitaxel"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2005-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-02", "Study_Completion_Date(Actual)" : "2009-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-08-03", "First_Posted(Estimated)" : 2007-08-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2007-08-03", "Last_Update_Posted(Estimated)" : 2010-02-17", "Last_Verified" : 2010-02" } }}

#Study Description Brief Summary The purpose of this study is to test SU011248 (sunitinib) in combination with paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor activity. #Intervention - DRUG : carboplatin + SU011248 (sunitinib) + paclitaxel - AUC of 6 mg\*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity. - Other Names : - Paraplatin; SUTENT; Taxol

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically proven diagnosis of any advanced solid malignancy that is not amenable to treatment with curative intent * Candidates for treatment with carboplatin and paclitaxel with maximum of 2 prior chemotherapy regimens * ECOG performance status 0 or 1 Exclusion Criteria: * Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target, metastatic lesions * Diagnosis of any second malignancy within the past 3 years 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

NCT00511849

{ "NCT_ID" : "NCT01309087", "Brief_Title" : "Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA", "Official_title" : "Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA", "Conditions" : ["Lung Cancer"], "Location_Countries" : ["Canada", "Ireland", "United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-05", "Study_Completion_Date(Actual)" : "2013-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-03-03", "First_Posted(Estimated)" : 2011-03-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-03-03", "Last_Update_Posted(Estimated)" : 2014-03-26", "Last_Verified" : 2014-03" } }}

#Study Description Brief Summary The primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.

#Eligibility Criteria: Inclusion Criteria: * The patient is being evaluated for the diagnosis of possible lung cancer or 'rule out lung cancer' and is indicated for bronchoscopy. * The patient is undergoing bronchoscopy * >= 21 years * Patient meets local site's standard of care (SOC) for performing diagnostic bronchoscopy * The patient is a current or former cigarette smoker (defined as having smoked >100 cigarettes in their lifetime. Exclusion Criteria: * The Pulmonary physician does not recommend that bronchoscopy be performed * The patient is unable to be consented into the study or unable to comply with requirements of the study * The patient has previously been diagnosed with primary lung cancer * Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for >= 24 consecutive hours. 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

NCT01309087

{ "NCT_ID" : "NCT02214342", "Brief_Title" : "Virtual Reality Based Balance Training in People With Mild Cognitive Impairment", "Official_title" : "Virtual Reality Based Balance Training in People With Mild Cognitive Impairment: A Pilot Study", "Conditions" : ["Distorted; Balance", "Motor Deficit", "Cognitive Deficit"], "Interventions" : ["Other: Balance Training"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-09", "Study_Completion_Date(Actual)" : "2014-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-08-08", "First_Posted(Estimated)" : 2014-08-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-08-11", "Last_Update_Posted(Estimated)" : 2014-12-16", "Last_Verified" : 2014-12" } }}

#Study Description Brief Summary The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in people with mild cognitive impairment. The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in people with mild cognitive impairment compared to a control group receiving usual care only. #Intervention - OTHER : Balance Training - Experimental: Balance Training Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as 'ankle reaching' and 'obstacle crossing' using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.

#Eligibility Criteria: Inclusion Criteria: * diagnosis of Mild Cognitive Impairment * willingness to provide informed consent Exclusion Criteria: * severe neurologic, cardiovascular, metabolic, or psychiatric disorders * severe visual impairment * severe cognitive impairment * dementia Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT02214342

{ "NCT_ID" : "NCT00225199", "Brief_Title" : "Efficacy and Safety of SH T00660AA in Treatment of Endometriosis", "Official_title" : "A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Oral Administration of SH T00660AA for the Treatment of Endometriosis Over 12 Weeks", "Conditions" : ["Endometriosis"], "Interventions" : ["Drug: Placebo", "Drug: Visanne (BAY86-5258, SH T00660AA)"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2004-03", "Study_Completion_Date(Actual)" : "2006-09}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2005-09-22", "First_Posted(Estimated)" : 2005-09-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2005-09-22", "Last_Update_Posted(Estimated)" : 2010-04-23", "Last_Verified" : 2010-04" } }}

#Study Description Brief Summary The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis Detailed Description The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial. #Intervention - DRUG : Visanne (BAY86-5258, SH T00660AA) - orally once daily - DRUG : Placebo - orally once daily

#Eligibility Criteria: Inclusion Criteria: * Female patients with endometriosis-associated pelvic pain Exclusion Criteria: * Pregnant or lactating women * history or suspicion of hormone dependent tumor * therapy resistant endometriosis * need for primary surgical treatment * any other conditions which forbid the participation. 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

NCT00225199

{ "NCT_ID" : "NCT00336830", "Brief_Title" : "Improving Cardiac Rehabilitation Participation in Women and Men", "Official_title" : "Improving Cardiac Rehabilitation Participation in Women and Men", "Conditions" : ["Myocardial Infarction", "Unstable Angina", "Coronary Disease"], "Interventions" : ["Behavioral: Standard Cardiac Rehabilitation referral", "Behavioral: MD-endorsed Cardiac Rehabilitation referral"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2003-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-06", "Study_Completion_Date(Actual)" : "2009-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2006-06-13", "First_Posted(Estimated)" : 2006-06-14" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2006-06-13", "Last_Update_Posted(Estimated)" : 2014-03-27", "Last_Verified" : 2014-03" } }}

#Study Description Brief Summary The purpose of this study is to determine the effect of a pre-discharge written personal endorsement to the patient by the patient's attending cardiologist or cardiac surgeon (MD endorsement) to take part in the Cardiac Rehabilitation and Secondary Prevention (CR) program, in addition to the standard CR referral, compared to the standard CR referral alone, on CR program enrollment within 2 months of index hospital discharge following admission for myocardial infarction, unstable angina, coronary angioplasty, or coronary artery bypass. Detailed Description There is compelling evidence that a comprehensive CR program comprising the delivery of lifestyle modifying education will reduce mortality, morbidity and improve quality of life in patients following myocardial infarction, angioplasty or, coronary artery bypass. However, less than 20% of eligible patients participate in CR programs. This study will look at a method of potentially improving enrollment and adherence to a CR program. It is expected that patients who receive the MD-endorsed referral will be more likely to attend the initial Orientation appointment and more closely adhere to the 6-month comprehensive CR program, as compared to the patients who receive a standard CR referral alone. #Intervention - BEHAVIORAL : MD-endorsed Cardiac Rehabilitation referral - Note to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician. - Other Names : - MD endorsed referral to Cardiac Rehabilitation - BEHAVIORAL : Standard Cardiac Rehabilitation referral - Note to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician. - Other Names : - Standard Referral to Cardiac Rehabilitation

#Eligibility Criteria: Inclusion Criteria: * Patient is admitted to hospital for myocardial infarction (MI), unstable angina (UA), percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass surgery (CABS) * Patient resides within 1 hour driving time from London Exclusion Criteria: * Inability to provide written informed consent or complete survey due to language or cognitive difficulties * Previous cardiac rehabilitation participation * Patient scheduled to undergo PTCA or CABS within two months following the index hospital discharge * Inability to exercise due to musculoskeletal problems or previous or current stroke 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

NCT00336830

{ "NCT_ID" : "NCT01811888", "Brief_Title" : "Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.", "Official_title" : "Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.", "Conditions" : ["Knee Osteoarthritis"], "Interventions" : ["Behavioral: Quantitative sensory testing (QST)"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12", "Study_Completion_Date(Actual)" : "2015-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-03-13", "First_Posted(Estimated)" : 2013-03-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-03-13", "Last_Update_Posted(Estimated)" : 2016-03-31", "Last_Verified" : 2016-03" } }}

#Study Description Brief Summary This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery. #Intervention - BEHAVIORAL : Quantitative sensory testing (QST)

#Eligibility Criteria: Inclusion Criteria: * >= 18 years patients * Scheduled for primary total knee arthroplasty * Disposition to visits and scheduled tests Exclusion Criteria: * Previous surgery on knee to be operated * Documented peripheral neuropathy * Severe disease or condition that could potentially interfere with interpretation of tests. 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

NCT01811888

{ "NCT_ID" : "NCT04912388", "Brief_Title" : "Serum Cytokine Levels in Patients with Lumbal Disc Herniation and Effectiveness of Exercise", "Official_title" : "Serum Cytokine Levels in Patients with Lumbal Disc Herniation with and Without Neurological Deficits and Effectiveness of Exercise", "Conditions" : ["Low Back Pain"], "Interventions" : ["Other: Lumbal stabilization excercises", "Other: Conventional exercises"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-07-30", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-02-23", "Study_Completion_Date(Actual)" : "2024-07-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-05-28", "First_Posted(Estimated)" : 2021-06-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-05-28", "Last_Update_Posted(Estimated)" : 2024-10-02", "Last_Verified" : 2024-03" } }}

#Study Description Brief Summary The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study. Detailed Description The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study. Healthy individuals of similar age, height and weight will also be included for references to normal serum cytokine levels. All patients will be evaluated twice, before and 6 weeks after treatment. The treatment program will be applied 3 times a week for 6 weeks under the supervision of a physiotherapist. #Intervention - OTHER : Lumbal stabilization excercises - The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks. - OTHER : Conventional exercises - The general exercise group will perform conventional exercises 3 times a week during 6 weeks.

#Eligibility Criteria: Inclusion Criteria for patients with disc herniation: * Diagnosis of disc herniation (protrusion, extrusion, sequestered disc) * not an indication for lumbar disc herniation surgery * for patients with neurological deficits, loss of strength, decrease in DTRs, loss of sensation and at least one positive SLR test and presence of radicular pain * pain intensity of VAS >= 3 * male and female patients between the ages of 20 <= age <= 55 Inclusion Criteria for heathy people * not having low back pain complaints in the past * female and male healthy individuals between the ages of 20 <= age <= 55 Exclusion Criteria: * systemic or inflammatory disease * pregnant or breastfeeding women * surgery of lumbar region * fracture of lumbar vertebrae * lumbar scoliosis * medication use for psychiatric disorders * tumor * allergy * neurological disease * alcohol-drug use * generalized musculoskeletal pain Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT04912388

{ "NCT_ID" : "NCT05005429", "Brief_Title" : "Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma", "Official_title" : "A Phase II Single Arm Clinical Trial Assessing the Efficacy and Safety of BIntrafusp Alfa (M7824) in Previously Treated Advanced Malignant Pleural MESothelioma (BIMES)", "Conditions" : ["Mesothelioma; Lung"], "Interventions" : ["Drug: Bintrafusp alfa"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-09-20", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-02-01", "Study_Completion_Date(Actual)" : "2024-02-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-08-10", "First_Posted(Estimated)" : 2021-08-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-08-12", "Last_Update_Posted(Estimated)" : 2024-09-19", "Last_Verified" : 2024-09" } }}

#Study Description Brief Summary This is an open-label, non-randomized, phase II, single arm, multi-center controlled clinical trial. 47 patients will be enrolled in this trial to determine the efficacy and safety of Bintrafusp alfa (M7824) in advanced malignant pleural mesothelioma patients previously treated with platinum-based chemotherapy. Detailed Description This is an open-label, non-randomized, phase II, single arm, multi-center controlled clinical trial. Patients enrolled will receive Bintrafusp alfa (M7824) 1200mg intravenous. The treatment will be administered at day 1 of 14-day intervals.Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. The primary objective is to determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1. Patient accrual is expected to be completed within 1.5 years excluding a run-in-period of 3-6 months. Treatment and follow-up are expected to extend the study duration to a total of 3.5 years. Patients will be followed 1 month after treatment. The study will end once survival follow-up has concluded. #Intervention - DRUG : Bintrafusp alfa - Bintrafusp alfa (M7824) is a bifunctional fusion protein composed of the extracellular domain of the transforming growth factor β (TGF-β) receptor II (a TGF-β 'trap') fused to a human immunoglobulin G1 antibody blocking programmed death-ligand 1 (PD-L1). Day 1 of week 1 of treatment will start within 1-5 days from enrollment. Cycles will be administered every 2 weeks (±3 days) until progression or other reason to discontinue. If a pseudoprogression is suspected patient is allowed to continue treatment until loss of clinical benefit as judged by principal investigator and after the permission from the trial chair is granted. On Day 1 of each cycle (QW2), all eligible patients will receive: Bintrafusp alfa (M7824): 1200mg, IV infusion over 60 minutes Current experience revealed that IRRs to bintrafusp alfa occur seldomly and are generally mild to moderate in severity. Therefore, administration of a premedication is generally not required. - Other Names : - M7824

#Eligibility Criteria: Inclusion Criteria: * Male or female subjects aged >= 18 years and capable of giving signed informed consent or requirement per local legislation. * ECOG performance status of 0 <= age <= 2. * Histologically confirmed malignant pleural mesothelioma (all histological subtypes are eligible), unresectable advanced or metastatic. * Patients that progressed or be intolerant to <= 2 regimens of chemotherapy, including platinum-based chemotherapy with pemetrexed. Prior bevacizumab treatment given during chemotherapy are allowed. * Evaluable disease or measurable disease as assessed according to the modified RECIST v1.1 criteria. * Availability of tumor tissue for translational research (at least 10 slides); Archival tumor tissue at diagnosis can be sent if it was obtained less than 18 months ago. * Life expectancy of at least 3 months. * Adequate hematologic and organ function defined by the following laboratory results obtained within 14 days prior to enrollment: Hematologic: Absolute neutrophil count (ANC) >= 1.5 × 109/L, platelet count >= 100 × 109/L, and hemoglobin >= 9 g/dL Hepatic: Total bilirubin level <= the upper limit of normal (UNL) range, AST and ALT levels <= 1.5 x ULN and ALP <= 2.5 x ULN. For participants with liver involvement in their tumor, AST <=5 x ULN, ALT <= 5 x ULN, and bilirubin <= 3.0 x ULN. Renal: Creatinine level <=1.5 x ULN or estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) For participants with Creatinine > 1.5 x ULN, glomerular filtration rate (GFR) can also be used. Coagulation: normal international normalized ratio (INR), PT <= 1.5 x ULN and activated partial thromboplastin time (aPTT) <= 1.5 x ULN. * Stable HIV infection on ART for at least 4 weeks, no documented evidence of multi-drug resistance, viral load of < 400 copies/ml and CD4+ T-cells >= 350 cells/μL. * Controlled HBV/HCV infection on a stable dose of antiviral therapy, HBV viral load below the limit of quantification. HCV viral load below the limit of quantification. * All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention. * For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate (< 1% per year) when used consistently and correctly throughout the study and for at least 2 months after last bintrafusp alfa treatment administration . * For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate [< 1% per year] when used consistently and correctly. * Women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug. Exclusion Criteria: * Prior immune checkpoint therapy with an anti-PD-1, anti-PD-L1, anti-CD137, or anti-CTLA-4 antibody. * Known severe hypersensitivity [Grade >= 3 NCI CTCAE 5.0]) to investigational product or any component in its formulations, any history of anaphylaxis, or recent, within 5 months, history of uncontrollable asthma. * Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years. Participants with a history of cervical carcinoma in situ, superficial or noninvasive bladder cancer, localized prostate cancer or basal cell or squamous cell carcinoma in situ previously treated with curative intent and endoscopically resected GI cancers limited to the mucosal layer without recurrence in > 1 year are NOT excluded. * Active central nervous system (CNS) metastases and/or carcinomatous meningitis that require therapeutic intervention or are causing clinical symptoms. Patients with previously treated brain metastases may participate provided the participants are stable and are not using steroids for at least 7 days prior to randomization. * Prior major surgery within 4 weeks prior to the first dose of study intervention. * Unstable or unresolved surgical or chemotherapy-related toxicity that would compromise the patient's capacity to participate in the trial. Persisting Grade > 1 NCI CTCAE 5.0 toxicity (except alopecia and vitiligo) related to prior therapy; however, sensory neuropathy Grade <= 2 is acceptable. * Prior organ transplantation including allogenic stem-cell transplantation, except transplants that do not require immunosuppression. * Live vaccines given 30 days prior to first dose of protocol treatment (M7824). Seasonal flu vaccines that do not contain a live virus are permitted. Also, COVID-19 vaccines approved by the authorities that do not contain live virus are permitted. * Drug-induced interstitial lung disease (ILD) or participant has had a history of drug-induced pneumonitis that has required oral or IV steroids, and/or other diseases, which in the opinion of the Investigator might impair the participant's tolerance for the study or ability to consistently participate in study procedures. * Active and serious autoimmune disease that might deteriorate upon treatment with immunotherapy. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. Replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) or topical therapy (e.g., steroids) for psoriasis or eczema is not considered a form of systemic treatment. * Ongoing clinically serious infections requiring systemic antibiotic or antiviral, antimicrobial, or antifungal therapy. * Known history of active tuberculosis or any active infection requiring systemic therapy. * Patients with diagnosed immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization. * Clinically significant cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. * History of bleeding diathesis or recent major bleeding events (i.e. Grade >= 2 bleeding events in the month prior treatment) * Patients with any serious underlying medical condition that might impair patient's capacity to participate in the trial. * Substance or alcohol abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial results. * Women who are pregnant or in the period of lactation. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05005429

{ "NCT_ID" : "NCT02867891", "Brief_Title" : "Sorafenib In Relapse of FMS-like Tyrosine Kinase 3 (FLT3)-Internal Tandem Duplication (ITD) AML Trial", "Official_title" : "Multicenter, Observational Trial to Determine the Response Rate of Sorafenib and Donor Lymphocyte Infusions (DLI) Versus Best Available Treatment (BAT) in FLT3-ITD-mutant AML Relapse After Allogeneic Hematopoietic Cell Transplantation", "Conditions" : ["Acute Myeloid Leukemia"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2001-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-12", "Study_Completion_Date(Actual)" : "2016-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-08-10", "First_Posted(Estimated)" : 2016-08-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-08-13", "Last_Update_Posted(Estimated)" : 2017-01-18", "Last_Verified" : 2017-01" } }}

#Study Description Brief Summary In this trial the investigators will evaluate the outcomes of 4 pre-defined groups of individuals according to the therapeutic intervention. The investigators will determine the outcome of each group by monitoring the survival and the response rates of patients with FLT3-ITD AML relapse after allo-HSCT. Detailed Description The preliminary data of the investigators demonstrate potent activity of Sorafenib combined with Donor lymphocyte infusions (DLI) in relapse of FLT3-ITD+ Acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (allo-HSCT). The investigators therefore launched an observational multicenter trial. The outcomes are assessed in 4 pre-defined groups of individuals according to the therapeutic intervention (chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group). The specific interventions to the subjects of the study are assigned by the individual transplant center. The investigators will determine the outcome of each group by monitoring the survival and the response rates (complete remission, disease burden reduction, no response) of patients with FLT3-ITD AML relapse after allo-HSCT.

#Eligibility Criteria: Inclusion Criteria: * Histology/PCR proven relapse of FLT3-ITD+ AML after allo-HSCT * Age >=18 years * Treatment with either chemotherapy-alone, chemotherapy/DLI, sorafenib alone or sorafenib/DLI * Written informed consent * Ability to understand the nature of the study and the study related procedures and to comply with them Exclusion Criteria: * Age < 18 years * Lack of informed consent * Patients that cannot be classified in one of the 4 groups: chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group 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

NCT02867891

{ "NCT_ID" : "NCT05411835", "Brief_Title" : "Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders", "Official_title" : "Safety and Tolerability of Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders", "Conditions" : ["Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency", "Carnitine Palmitoyltransferase Deficiency 2", "Very Long Chain Acyl Coa Dehydrogenase Deficiency", "Trifunctional Protein Deficiency"], "Interventions" : ["Dietary Supplement: Isocaloric Placebo Supplement", "Dietary Supplement: Nutritional Ketone Supplement"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-08-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-01-31", "Study_Completion_Date(Actual)" : "2024-01-22}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-05-27", "First_Posted(Estimated)" : 2022-06-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-06-06", "Last_Update_Posted(Estimated)" : 2024-04-02", "Last_Verified" : 2022-10" } }}

#Study Description Brief Summary The purpose of the study is to determine if an oral ketone beverage is safe and well-tolerated during moderate intensity exercise in participants with long-chain fatty acid oxidation disorders and if it will raise blood ketones to levels similar to that reported among normal healthy subjects. Detailed Description Purpose: Subjects with long-chain fatty acid oxidation disorders (LC-FAOD) do not make ketones during fasting or with exercise. Ketones are an important alternative energy substrate during moderate exercise, sparing the oxidation of glucose and providing a source of ATP to the central nervous system and exercising muscle. Fatty acid oxidation in the liver is required to make ketones. Subjects with a LC-FAOD cannot generate ketones because of their block in fatty acid oxidation during exercise. Providing ketones in an oral ketone beverage may increase blood ketones with exercise to levels normally observed in humans. Aim: To determine the safety and tolerability of an oral ketone beverage during moderate intensity exercise among subjects with a LC-FAOD compared to an isocaloric maltodextrin beverage, and to determine blood ketone concentrations. Hypothesis: Oral consumption of a ketone beverage before moderate intensity exercise will be safe and well-tolerated, and will raise blood ketones among subjects with a LC-FAOD to concentrations similar to that reported in the literature among normal healthy subjects. #Intervention - DIETARY_SUPPLEMENT : Nutritional Ketone Supplement - Mix of sodium, calcium, and magnesium salts of D-beta-hydroxybutyrate with nicotinamide riboside chloride, flavors and stevia sweetener - Other Names : - NKS - DIETARY_SUPPLEMENT : Isocaloric Placebo Supplement - Maltodextrin with flavors and stevia sweetener

#Eligibility Criteria: Inclusion Criteria: * confirmed diagnosis of VLCAD, LCHAD/TFP or CPT2 deficiency * speak English * willing to complete 2 moderate intensity exercise treadmills Exclusion Criteria: * subjects actively participating in another research study that prohibits their participation * pregnant females * subjects with diabetes or taking medications to treat diabetes Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05411835

{ "NCT_ID" : "NCT03051347", "Brief_Title" : "Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments", "Official_title" : "AAD-PEPR: Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments Sub-Study: Clinically Relevant Endpoints in Atopic Dermatitis in Children (CREAD-C)--Funded by Regeneron", "Conditions" : ["Atopic Dermatitis", "Ichthyosis", "Psoriasis"], "Interventions" : ["Other: Itch Questionnaire and Interview", "Other: Cognitive Interview and PROMIS Itch Questionnaire", "Other: Stigma Questionnaire and Interview"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-02-09", "Study_Completion_Date(Actual)" : "2020-06-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-02-09", "First_Posted(Estimated)" : 2017-02-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-02-09", "Last_Update_Posted(Estimated)" : 2020-10-09", "Last_Verified" : 2020-10" } }}

#Study Description Brief Summary This is designated to validate patient-reported outcomes (PRO) measures in itch-specific pediatric skin conditions, such as atopic dermatitis, and examine the ability of a modified stigma instrument to assess the severity and type of stigma experienced in atopic dermatitis and other potentially stigmatizing conditions. Detailed Description This study involves a series of research and development projects targeted at two of the most common chronic diseases affecting children: asthma and atopic dermatitis (AD, or eczema). The Investigators propose to directly validate patient-reported outcomes (PRO) measures in a large cohort of itch-specific pediatric skin conditions, with a primary focus on AD. The Investigators propose to examine the ability of PROMIS (Patient-Reported Outcomes Measurement Information Systems) instruments to detect meaningful and clinically significant change in disease status, as well as to create a pediatric itch item pool and PRO model for signs and symptoms of skin disease. The Investigators will also examine the ability of a modified Neuro-QOL stigma instrument to assess the severity and type of stigma experienced in AD and across various dermatologic or other potentially stigmatizing conditions. Lurie Children's Hospital will only be involved in the AD and stigma portions of this project #Intervention - OTHER : Itch Questionnaire and Interview - OTHER : Stigma Questionnaire and Interview - OTHER : Cognitive Interview and PROMIS Itch Questionnaire

#Eligibility Criteria: Inclusion Criteria: * Affected children must have moderate to severe AD or another skin condition that causes itch, experience itch, understand English, and be able to complete an English-based survey * Any child with a potentially disfiguring skin condition or change in appearance related to disease/intervention will be considered eligible. Parents of children with such conditions will also be asked to participate. Children and parents must also understand English and be able to complete an English-based survey Sub-study Inclusion Criteria: * Patients ages 8 years-17 years with a diagnosis of mild AD * Patients ages 6 months to 8 years with a diagnosis of AD (any severity) * English speaking * Families must be able to access the internet (e.g., Skype or Facetime) for follow-up, or be able to come for follow-up within five days of an AD flare and again when improved. * Patients with developmental delay and/or a behavioral disorder that would preclude participation in form completion will not be eligible for this study. Sex : ALL Ages : - Minimum Age : 0 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT03051347

{ "NCT_ID" : "NCT06300866", "Brief_Title" : "Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste", "Official_title" : "The Clinical Investigation of Stannous Fluoride Containing Toothpaste Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in California", "Conditions" : ["Gingivitis", "Plaque, Dental"], "Interventions" : ["Drug: Test", "Drug: Control"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-08-18", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-08", "Study_Completion_Date(Actual)" : "2021-03-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2024-03-03", "First_Posted(Estimated)" : 2024-03-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2024-03-03", "Last_Update_Posted(Estimated)" : 2024-03-08", "Last_Verified" : 2024-03" } }}

#Study Description Brief Summary The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use. #Intervention - DRUG : Test - test toothpaste containing 0.45% stannous fluoride - DRUG : Control - toothpaste containing 0.76% sodium monofluorophosphate

#Eligibility Criteria: Inclusion Criteria: * Potential subjects must meet all of the following criteria * Subjects, ages 18 <= age <= 70, inclusive * Availability for the six-month duration of the clinical research study * Good general health * Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index * Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index * Signed Informed Consent Form Exclusion Criteria: * Presence of orthodontic appliances * Presence of partial removable dentures * Tumor(s) of the soft or hard tissues of the oral cavity * Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study * Five or more carious lesions requiring immediate restorative treatment * Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study * Dental prophylaxis during the past two weeks prior to baseline examinations * History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome * An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours * History of alcohol and/or drug abuse * Self-reported pregnancy and/or lactating subjects. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT06300866

{ "NCT_ID" : "NCT02879422", "Brief_Title" : "Genetic Markers and Proliferative Diabetic Retinopathy", "Official_title" : "Study of the Association Between Genetic Markers (Endothelial Lipase and Aldose Reductase) and Proliferative Diabetic Retinopathy", "Conditions" : ["Proliferative Diabetic Retinopathy"], "Interventions" : ["Genetic: genetic analysis"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-10-16", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-03-03", "Study_Completion_Date(Actual)" : "2021-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-08-22", "First_Posted(Estimated)" : 2016-08-25" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-08-24", "Last_Update_Posted(Estimated)" : 2021-02-15", "Last_Verified" : 2021-02" } }}

#Study Description Brief Summary Type 2 Diabetes (TD2) is the leading cause of new cases of preventable blindness in these countries (and the gold-standard treatment, laser photocoagulation has proven to be effective in preventing vision loss at the end stage of eye disease due to proliferative diabetic retinopathy (PDR) that occurs in 3 to 6 % of the cases.Therefore, the ongoing search for predictive factors of sight threatening stages of diabetic retinopathy has become more important. Previous studies that have examined candidate predictive factors for diabetic eye disease have mostly focused on systemic risk factors leading to PDR. Among various clinical parameters, increased HbA1c % levels, uncontrolled blood pressure, diabetes duration, neuropathy and elevated triglycerides have been associated with PDR. Some genetic factors may also account for the development of PDR and are prospectively considered in this study . Detailed Description In a previous study (2011), investigators demonstrated a statistically significant relation between the Endothelial Lipase(EL) c.584C\>T polymorphism and the occurrence of diabetic retinopathy in 396 french patients with diabetes type 2 (DT2) with a longitudinal follow-up. Secondly (2014) in a subgroup of 287 DT2 patients, investigators showed the impact of the EL rare T allele was consistent with a recessive mode of inheritance, with homozygotes for the rare allele differing from the carriers of the major allele. Importantly, the homozygotes for the rare T allele were more likely to present with advanced stages of diabetic retinopathy (severe non proliferative and proliferative disease) and particularly with proliferative diabetic retinopathy (PDR). Based on this model investigators decided to conduct a case-control prospective study comparing 155 french patients with DT2 with PDR (cases) and 155 french patients with DT2 without PDR (controls) on the basis of two genetic parameters: EL c.584C\>T polymorphism that investigators previously studied and the C(-106)T aldose reductase polymorphism widely studied in diabetic retinopathy. #Intervention - GENETIC : genetic analysis

#Eligibility Criteria: Inclusion Criteria: * type 2 diabetic patients * patient with proliferative diabetic retinopathy (for arm 1) * patient with non proliferative diabetic retinopathy (for arm 2) * patient older than 18 years * patient consenting to participate to the study * patient enrolled in the national healthcare insurance program 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

NCT02879422

{ "NCT_ID" : "NCT01744067", "Brief_Title" : "The Effects of Omega-3 Fatty Acids in Renal Transplantation", "Official_title" : "The Effects of n-3 Polyunsaturated Fatty Acids on Renal and Cardiovascular Risk Markers in Renal Transplant Recipients: a Randomized Double Blinded Placebo Controlled Intervention Study.", "Conditions" : ["Disorder Related to Renal Transplantation"], "Interventions" : ["Drug: Placebo", "Drug: Omega-3 fatty acids"], "Location_Countries" : ["Norway"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12", "Study_Completion_Date(Actual)" : "2015-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-12-04", "First_Posted(Estimated)" : 2012-12-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-12-04", "Last_Update_Posted(Estimated)" : 2015-12-08", "Last_Verified" : 2015-12" } }}

#Study Description Brief Summary Omega-3 fatty acids are provided through dietary intake of fish and seafood. Several dietary supplements containing omega-3 fatty acids are also commercially available. Some studies have described beneficial effects from omega-3 fatty acids, among them are anti-inflammatory, anti-thrombotic, anti-atherosclerotic, anti-arrhythmic, anti-hypertensive and lipid-modulating effects. Other studies have not confirmed these findings. This study will investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients. Detailed Description There have been few interventional studies regarding the clinical effect of omega-3 fatty acids in renal transplantation. The aim of this study is to investigate the effects of omega-3 fatty acids on renal function and cardiovascular risk markers in renal transplant recipients. This study is a randomized double blinded placebo controlled interventional study of 132 Norwegian renal transplant recipients. It will investigate, on the one hand, the effect of omega-3 fatty acids on renal function and, on the other, the effect of omega-3 fatty acids on cardiovascular risk markers in renal transplant recipients. 8 weeks after transplantation, if renal function has stabilized, patients with a eGFR\>30 will be randomized to receive either 2,7 g eicosapentaenoic plus docosahexaenoic acid (3 capsules of Omacor a 1 g) daily or placebo. Baseline measurements will be performed before they start taking the study medication. The same measurements will performed again1 year after transplantation and the patients stops taking the study medication. #Intervention - DRUG : Omega-3 fatty acids - 2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration) - Other Names : - Omacor - DRUG : Placebo - Placebo capsules 3 times a day (oral administration) - Other Names : - Olive oil

#Eligibility Criteria: Inclusion Criteria: * Patients over the age of 18 who have received a kidney transplant. Patients with a functioning kidney transplant, defined as eGFR>30 ml/min. Signed informed consent. Exclusion Criteria: * Patients participating in clinical trials with other investigational drugs. Patients who received a deceased donor kidney from a donor >75 years. Patients with a history of an allergic reaction or significant sensitivity to the study drug or drugs similar to the study drug. 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

NCT01744067

{ "NCT_ID" : "NCT01927822", "Brief_Title" : "Factors Influencing the Abortion Interval of Second-trimester Termination of Pregnancy Using Misoprostol", "Conditions" : ["Labor Induction"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-08", "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" : 2013-08-18", "First_Posted(Estimated)" : 2013-08-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-08-20", "Last_Update_Posted(Estimated)" : 2015-07-07", "Last_Verified" : 2015-07" } }}

#Study Description Brief Summary This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol. Detailed Description Misoprostol is the primary drug of choice for medical termination. It is not only cheap, but also stable at room temperature and easily available worldwide. It is indicated for the treatment of gastritis, but is widely used off-label for a variety of indications in the practice of obstetrics and gynecology, including medication abortion, induction of labor, and the treatment of postpartum hemorrhage. The optimal dosage and route of administration have not been well defined and vary with physicians. The potency of misoprostol's effect varies with dosage, route of administration and dosing interval; both maternal and fetal factors may, to certain extent, affect the abortion interval. This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.

#Eligibility Criteria: Inclusion Criteria: *All female patients who were admitted for medical termination of second-trimester pregnancy Exclusion Criteria: * Patients who are allergy to Cytotec. Sex : FEMALE Ages : - Minimum Age : 13 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT01927822

{ "NCT_ID" : "NCT00631397", "Brief_Title" : "A Preliminary Study of Bone Density in Neonates", "Official_title" : "A Preliminary Study of Bone Density Measurements in Neonates Using the Sunlight Omnisense 7000P Ultrasound Bone Sonometer", "Conditions" : ["Osteopenia Of Prematurity"], "Interventions" : ["Device: Ultrasound machine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-05", "Study_Completion_Date(Actual)" : "2008-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-02-27", "First_Posted(Estimated)" : 2008-03-07" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-02-27", "Last_Update_Posted(Estimated)" : 2012-06-15", "Last_Verified" : 2007-03" } }}

#Study Description Brief Summary The study is to measure how dense or solid the infant's bones are using a new ultrasound machine and how that density changes over time. Detailed Description premature infants weighing less than 1500 gms and less than 33 weeks gestation are eligible for the study #Intervention - DEVICE : Ultrasound machine - Weekly Bone Density measurements using the Sonometer - Other Names : - Omnisense 7000P Ultrasound Bone Sonometer

#Eligibility Criteria: Inclusion Criteria: * premature infants born less than 33 weeks, weighing less than 1500 gms Exclusion Criteria: * congenital anomalies weight greater than 1500 gms Sex : ALL Ages : - Minimum Age : 24 Weeks - Maximum Age : 33 Weeks - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes

NCT00631397

{ "NCT_ID" : "NCT00000861", "Brief_Title" : "The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients", "Official_title" : "A Randomized Trial of Immediate Versus Deferred Indinavir in Addition to Background Antiretroviral Therapy in HIV-Infected Patients With CD4+ Cell Counts Between 200 and 500/mm3 and Plasma HIV RNA Levels >= 10,000 Copies/ml", "Conditions" : ["HIV Infections"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Completion_Date(Actual)" : "1997-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 1999-11-02", "First_Posted(Estimated)" : 2001-08-31" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2001-08-30", "Last_Update_Posted(Estimated)" : 2021-10-28", "Last_Verified" : 2021-10" } }}

#Study Description Brief Summary The purpose of this study is to evaluate the effect of immediate versus deferred indinavir (IDV) in addition to background therapy on disease progression or death in patients with CD4+ cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels \>= 10,000 copies/ml. This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients. Detailed Description This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients. Prior to randomization the patient and clinician will determine whether the background therapy will be zidovudine (ZDV) plus lamivudine (3TC) or other background antiretroviral therapy (OBAT). Patients will then be randomized to IDV or matching placebo. AS PER AMENDMENT 06/27/97: The protocol was closed as of 03/25/97, and all patients have been unblinded to their assigned treatment. Patients still on study medication are eligible for the protocol extension. Patients who were randomized to immediate IDV may continue on therapy for up to an additional 4 months. All study therapy, both for those on immediate or delayed therapy, must be discontinued on 10/24/97. #Intervention - DRUG : Indinavir sulfate

#Eligibility Criteria: Inclusion Criteria Concurrent Medication: Allowed: * Topical and/or antifungal agents, except ketoconazole. * Treatment, maintenance, or chemoprophylaxis with approved agents for OIs will be given as clinically indicated. * Clinically indicated antibiotics, unless excluded. * Systemic corticosteroid use for <21 days for acute problems is permitted as clinically indicated. However, chronic systemic corticosteroid use should be avoided. * Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim). * Didanosine (ddI). * Regularly prescribed medications, such as antipyretics, antidepressants, oral contraceptives, megestrol acetate, testosterone, or any other medication. Patients must have: * A working diagnosis of HIV infection. * A CD4+ count between 200 and 500 cells/mm3. * Signed, informed parental consent if patient is less than 18. NOTE: * The DAIDS Clinical Science Research Committee (CSRC) has deemed this protocol appropriate for prisoner enrollment. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions or symptoms are excluded: Febrile illness with temperature > 38.5 degrees C (101.3 degrees F) within 3 days prior to study entry. Concurrent Medication: Excluded: * Non-nucleoside reverse transcriptase inhibitors. * Protease inhibitors except IDV. * Rifabutin and rifampin. * Ketoconazole. * Terfenadine, astemizole, cisapride, triazolam and midazolam. Patients with any of the following prior conditions are excluded: * History of prior saquinavir (SQV) therapy for more than 14 days. * History of any prior protease inhibitor therapy other than SQV. * History of serious opportunistic infection. Sex : ALL Ages : - Minimum Age : 16 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT00000861

{ "NCT_ID" : "NCT04612855", "Brief_Title" : "Post-traumatic Neuropathy of the Trigeminal Nerve", "Official_title" : "Post-traumatic Neuropathy of the Trigeminal Nerve", "Conditions" : ["Nerve Injury", "Orofacial Pain", "Trigeminal Nerve Injuries", "Trigeminal Neuropathy"], "Interventions" : ["Other: Groupwise comparison of primary and secondary outcomes"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-01-28", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-01", "Study_Completion_Date(Actual)" : "2020-10-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-10-28", "First_Posted(Estimated)" : 2020-11-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-10-28", "Last_Update_Posted(Estimated)" : 2020-11-04", "Last_Verified" : 2020-11" } }}

#Study Description Brief Summary This is retrospective research mainly aims to determine the patterns of symptoms, clinical and radiological findings and outcomes in patients with trigeminal neuropathy following trauma or iatrogenic damage and how this translates into costs for the patient and society, work disability and medication use. The trigeminal nerve and its branches are at risk of damage during multiple dental and maxillofacial procedures: endodontics, extractions, removal of wisdom teeth, implant placement, use of local anaesthesia, orthognatic surgery. In the event of damage to these nerve branches, there is a high risk of developing a neuropathic pain that is considered very disabling for patients and that interferes with daily activities (eating, drinking, speaking, kissing, etc.). Moreover, there are few medicinal or surgical techniques available to eliminate neuropathy or reduce the symptoms. Causal procedures (e.g. the removal of wisdom teeth) are among the most frequently performed surgical procedures. The number of injuries increases every year, partly due to an increase in dental procedures. The often relatively minimal intervention combined with the major impact of these injuries on the patient's quality of life sometimes leads to medico-legal actions. The limited symptom control with current therapies of these post-traumatic neuropathies of the trigeminal nerve causes frustration and impotence in both the patient and the attending physician, which can also lead to medical shopping. Based on chart analysis, this study will examine the causes, possible risk factors and presenting symptoms, how this is reflected in clinical research and examinations, and which treatments are being instituted. Patient records from the Oral and Maxillofacial Surgery department between January 2010 and October 2018 will be checked. In addition, we wish to check the costs incurred by these patients as well as the work disability. To this end, a collaboration is being organised with Christian Mutuality (CM), the largest health insurance provider in Belgium. In order to increase the power of the study, the clinical data from the already coded, retrospective dataset of Prof. Tara Renton, co-investigator, will be transferred to the dataset of this new study. #Intervention - OTHER : Groupwise comparison of primary and secondary outcomes - Statistical comparison of cohorts. Cfr supporting information on statistical plan.

#Eligibility Criteria: Inclusion Criteria: * Presentation with post traumatic, iatrogenic, injury of the trigeminal nerve or its branches (eg. inferior alveolar nerve, lingual nerve) * Iatrogenic nerve injury caused by M3 removal, implant placement, orthognathic surgery, endodontic therapy, non-M3 removal, local anesthesia injection, trauma. * Clinical diagnosis of neurosensory deficit in the distribution of the trigeminal nerve caused by a previous dental or maxillofacial procedure in the vicinity of the affected branch. Exclusion Criteria: * Neuropathic pain in another region than the trigeminal nerve * Neuropathic pain not caused by iatrogenic injury Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT04612855

{ "NCT_ID" : "NCT05068804", "Brief_Title" : "Intermittent Cooling During Baseball Games on Hitting and Defense Performance", "Official_title" : "Intermittent Cooling During Baseball Games Alleviated Perceived Exertion But Had no Effect on Hitting and Defense Performance in Hot Environment", "Conditions" : ["Decline, Cognitive"], "Interventions" : ["Other: control", "Procedure: Cooling"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-07-15", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-10", "Study_Completion_Date(Actual)" : "2020-09-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-09-06", "First_Posted(Estimated)" : 2021-10-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-09-24", "Last_Update_Posted(Estimated)" : 2021-10-06", "Last_Verified" : 2021-09" } }}

#Study Description Brief Summary This study adopted a practical approach in intermittent cooling on forehead and neck during an intra-squad baseball game. Exit velocity of batted balls was used as an indicator for hitting performance and a baseball-specific reactive agility test to evaluate the cognitive performance in defense. Detailed Description This study used a randomized cross-over design. Each participant completed a cooling and a non-cooling trial in a random order, separated by a 20-day washout period. Each trial contained a 7-inning intra-squad game in hot environment. Hitting, reactive agility, and cognitive tests were administered before and after the game. Forehead skin and tympanic temperature, perceived exertion, and thermal sensation were measured during the game. Experimental procedure After body weight and rectal temperature were measured in a temperature-controlled room, the participants consumed a standardized breakfast. The breakfast included white bread 1.2 g/kg, jam 0.1 g/kg, butter 0.l g/kg, and soybean milk 5 ml/kg (6.2 kcal/kg, containing carbohydrate 1.0 g/kg, protein 0.24 g/kg, and fat 0.14 g/kg). Go/NoGo and Stroop Color-Word tasks were administered after breakfast. After finishing the cognitive tests, the participants moved to the field for self-selected warm up, followed by hitting and reactive agility tests. After the intra-squad game, the participants repeated the hitting, reactive agility, and cognitive tests. The participants can drink water ad libitum during the experimental period. Intra-squad game The 7-inning intra-squad games were played under the standard rules of baseball in hot environmental conditions (temperature 31.1-33.4℃, humidity 63-67%). Cooling intervention The participants in the cooling trial put cold towels on their forehead and neck for 3 min in the shaded dugout during their offensive half innings when they were not scheduled to hit or on base. Each participant received the cooling intervention 3 to 4 times in each game. After each use, the towels were kept in a cooler that contained water mixed with ice and salt to keep the temperature at approximately 0℃. The participants in the control trial sat in the shaded dugout without any cooling intervention. Measurement of temperature Rectal temperature was measured before breakfast and after the game with a digital thermometer fitted with disposable sheaths. Forehead skin and tympanic temperature were measured with infrared thermometers during their offensive half innings in the dugout. Hitting test The participants used their own bat to hit balls thrown by a pitching machine positioned 12 m from the home plate. The ball speed was approximately 120 km/h. The participants were asked to make the best effort to hit the balls. Each test was consisted of 15 batted balls. Exit velocity was measured with a video system and swing power was measured with a sensor attached to the knob of the bat. Reactive agility test The infielders played defense against ground balls at the short stop position while the outfielders played defense against fly balls in center field. The participants were asked to move toward the ball as soon as they determine the trajectory and make the best effort to catch it. Each test was consisted of 15 batted balls. The reaction time, the time from bat-ball contact to the participant's first definitive movement in the intended direction, was calculated post-hoc using frame-by-frame analysis of the video footage by an experienced coach Cognitive tests The Go/NoGo and Stroop Color-Word tasks were administered on a laptop computer in a quiet room. Each task contained 100 trials. Perceived exertion and thermal sensation The participants reported their perceived exertion and thermal sensation during their offensive half innings. Perceived exertion was estimated with a 10-point Borg scale. Thermal sensation was estimated with a 7-point scale from -3 being the coolest to 3 being the hottest. #Intervention - PROCEDURE : Cooling - The participants in the cooling trial put cold towels on their forehead and neck for 3 min in the shaded dugout during their offensive half innings when they were not scheduled to hit or on base. Each participant received the cooling intervention 3 to 4 times in each game. After each use, the towels were kept in a cooler that contained water mixed with ice and salt to keep the temperature at approximately 0℃. - OTHER : control - The participants in the control trial sat in the shaded dugout without any cooling intervention.

#Eligibility Criteria: Inclusion Criteria: * baseball players from National Taiwan University of Sport, Taiwan * at least 6 years of experience in baseball training * have competed nationally. Exclusion Criteria: * having cardiovascular or other known chronic diseases * taking any medication in the preceding 2 months * having musculoskeletal injuries in the preceding 2 months. Sex : MALE Ages : - Minimum Age : 20 Years - Maximum Age : 23 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT05068804

{ "NCT_ID" : "NCT00133354", "Brief_Title" : "Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys", "Official_title" : "Double-blind Trial Investigating the Safety and Efficacy of the Inhibitor Anastrozole (ARIMIDEX) in Delaying Epiphyseal Fusion and Increasing Height Potential of Adolescent Males With Growth Hormone (GH) Deficiency", "Conditions" : ["Hypopituitarism"], "Interventions" : ["Drug: Arimidex (Anastrozole)", "Drug: Placebo", "Drug: Growth Hormone"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2001-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-08", "Study_Completion_Date(Actual)" : "2010-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2005-08-19", "First_Posted(Estimated)" : 2005-08-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2005-08-19", "Last_Update_Posted(Estimated)" : 2011-10-12", "Last_Verified" : 2011-10" } }}

#Study Description Brief Summary The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year trial. #Intervention - DRUG : Arimidex (Anastrozole) - Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH. - DRUG : Placebo - Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH. - DRUG : Growth Hormone - GH (Nutropin®, Genentech, So. San Francisco, CA) will be administered throughout the trial at a dose of \~0.3mg/kg.w (no more than 0.4mg/kg.w) given subcutaneously (SC) at bedtime daily. Dose adjustments on the GH dose will be made by the investigator at least every 6mo.

#Eligibility Criteria: Inclusion Criteria: * Growth hormone deficient by formal testing with two provocative agents. * Treated with growth hormone for a minimum of 6 months prior to study entry. * Growth hormone doses must be maintained at 0.2 <= age <= 0.4mg/kg/wk while in protocol. * Stable organic pathology * Presence of puberty [genital Tanner Stage > II (>4cc testicular volume)] * Bone age (BA) > or = 11.5 years and < 15 years Exclusion Criteria: * Participation in any other trial involving hormone therapy for at least 6 months prior. * Chronic illnesses requiring long term medication that impair growth. (Stable patients with occasional asthma, patients on Ritalin or Adderall or patients on topical acne medication may be included). * Hereditary disease diagnosed clinically. * Moderate to severe scoliosis. Sex : MALE Ages : - Minimum Age : 11 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT00133354

{ "NCT_ID" : "NCT01602419", "Brief_Title" : "Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease", "Official_title" : "Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease", "Conditions" : ["Von Willebrand Disease"], "Interventions" : ["Other: Patients using Wilate as standard of care"], "Location_Countries" : ["Sweden", "United States", "Portugal", "Germany", "Canada", "Spain", "Uruguay", "Argentina", "Czechia", "United Kingdom"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-04", "Study_Completion_Date(Actual)" : "2018-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-05-15", "First_Submitted_that_Met_QC_Criteria" : 2019-11-18", "First_Posted(Estimated)" : 2012-05-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-05-17", "Last_Update_Posted(Estimated)" : 2021-01-19", "Last_Verified" : 2020-12" } }}

#Study Description Brief Summary This is an observational study, hence there is no study hypothesis #Intervention - OTHER : Patients using Wilate as standard of care - Patients with von Willebrand Disease using Wilate for a period of 2 years.

#Eligibility Criteria: Inclusion Criteria: * Patients with a diagnosis of von Willebrand Disease who have been prescribed Wilate Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT01602419

{ "NCT_ID" : "NCT01300546", "Brief_Title" : "Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine", "Official_title" : "TreximetTM in the Prevention and Modification of Disease Progression in Migraine", "Conditions" : ["Migraine"], "Interventions" : ["Drug: Naproxen Sodium", "Drug: Sumatriptan/Naproxen Sodium"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-04", "Study_Completion_Date(Actual)" : "2012-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-01-12", "First_Submitted_that_Met_QC_Criteria" : 2013-05-17", "First_Posted(Estimated)" : 2011-02-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-02-18", "Last_Update_Posted(Estimated)" : 2013-05-21", "Last_Verified" : 2013-05" } }}

#Study Description Brief Summary This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine. Detailed Description Two investigative centers will enroll 40 subjects in the United States. Subject participation in the 5 visit study will last 4 months. At Visit 1, following informed consent, a medical, migraine, and medication history will be collected and a physical and neurological exam with vital signs will be performed. An electrocardiogram (ECG) will be completed. A Lifestyle Choices for Better Migraine Management Questionnaire (Lifestyle Questionnaire) will be completed. Eligible subjects then complete a 1-month Baseline Period and treat migraine with their current preferred treatment of choice, documenting headache severity and associated symptoms in a 30-day Baseline Diary. At Visit 2, the Baseline Diary will be reviewed and a pregnancy test will be collected from all subjects of childbearing potential. Vital signs will be collected and Adverse Events documented. Subjects continuing to meet eligibility criteria will be randomized 1:1 to Treximet or naproxen and provided with study medication to treat on 14 or fewer days per month. Subjects will be encouraged to treat their migraine attacks within 1 hour of onset of headache pain and while the pain is still mild. Subjects will view an educational digital video disc (DVD) concerning lifestyle modification, receive a copy for home viewing, complete the Lifestyle Questionnaire, and receive 3 copies of the Lifestyle Questionnaire for weekly completion between Visits 2 and 3. The Migraine Disability Assessment questionnaire (MIDAS) will be completed and a 30-day Treatment Period Diary will be dispensed. At Visits 3 and 4, Adverse Events will be collected, completed Diaries will be reviewed, and Drug Accountability performed. Pregnancy tests will be collected from all subjects of childbearing potential. Vital signs will be collected. Completed Lifestyle Questionnaires will be collected, a Lifestyle Questionnaire will be completed in the office, and 3 copies will be dispensed for weekly completion between visits. Study medication for the following month will be dispensed with a 30-day Diary. At Visit 5, Adverse Events will be collected, completed Diaries will be reviewed, and Drug Accountability performed. Pregnancy tests will be collected from all subjects of childbearing potential. Vital signs will be collected. Completed Lifestyle Questionnaires will be collected and a Lifestyle Questionnaire will be completed in the office. Subjects will complete the MIDAS before exiting the study. #Intervention - DRUG : Sumatriptan/Naproxen Sodium - Each tablet of Treximet for oral administration contains Sumatriptan 85mg / Naproxen Sodium 500mg. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period. - Other Names : - Treximet - DRUG : Naproxen Sodium - Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period. - Other Names : - Naproxen

#Eligibility Criteria: Inclusion Criteria: Subject * Is male or female, in otherwise good health, 18 <= age <= 65 of age. * Has history of frequent episodic migraine (6 <= age <= 14 migraine days per month) (with or without aura) according to the 2nd Edition of The International Headache Classification (ICHD-2) for at least 3 months. (Stage 2 <= age <= 3 frequent transforming migraine) * Had onset of migraine before age 50. * Is able to differentiate migraine from any other headache they may experience (e.g., tension-type headache). * Has stable history of headache at least 3 months prior to screening. * Is not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period. * Has at least 50% of migraine attacks beginning at mild severity. * If female of childbearing potential, has a negative urine pregnancy test at Visits 1 <= age <= 5 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator. 1. Complete abstinence from intercourse from 2 weeks prior to administration of study drug throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the study drug (a minimum of 7 days); or, 2. Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or, 3. Sterilization of male partner; or, 4. Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or, 5. Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or, 6. Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study. * Had 6 or more migraine treatment days in 1 month prior to Visit 2. Exclusion Criteria: Subject * Is unable to understand the study requirements, the informed consent, or complete headache records as required per protocol. * Is pregnant, actively trying to become pregnant, or breast-feeding. * Has experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine. * Has a history of Medication Overuse Headache in the 3 months prior to study enrollment or during the baseline phase * Has history of acute migraine treatment greater than14 days per month in 3 months prior to screening. * Has abused, in the opinion of the Investigator, any of the following drugs, currently or within the past 1 year: 1. opioids 2. alcohol 3. barbiturates 4. benzodiazepine 5. cocaine * Has history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study. * Has an unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure. * Suffers from cardiovascular disease (ischemic heart disease, including angina pectoris, myocardial infarction, documented silent ischemia, or with Prinzmetal's angina); has symptoms of ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome; has uncontrolled hypertension (>=140/90 millimeters of mercury (mmHg) in 2 out of 3 blood pressure (BP) measurements at screening); has electrocardiogram (ECG) results outside normal limits for clinically stable patients as judged by the investigator. * Has a history of asthma and nasal polyps. * Has a history of peptic ulcer disease requiring therapeutic intervention in the year prior to study enrollment * Has evidence or history of any gastrointestinal (GI) surgery or GI ulceration or perforation of the stomach or intestine in the past 6 months, gastrointestinal bleeding in the past year or evidence or history of inflammatory bowel disease or history of any other bleeding disorder, or has taken or plans to take any anti-coagulant or any antiplatelet agent within the 2 weeks prior to screening through 48 hours post final study treatment. * Has history of non-steroidal anti-inflammatory drug induced gastritis, esophagitis, or duodenitis. * Suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events. * Has in the opinion of the investigator a significant cardiovascular risk profile that may include uncontrolled high blood pressure, post-menopausal women, male > 40 years, hypercholesterolemia, obesity, diabetes mellitus, smoking, or a family history of cardiovascular disease in a 1st degree relative. * Has in the opinion of the investigator a significant cerebrovascular risk profile that may include female over the age of 35 using oral birth control, smoking, or a family history of cerebrovascular disease in a first degree relative. * Has a psychiatric condition, in the opinion of the investigator that may affect the interpretation of efficacy and safety data or contraindicates the subject's participation in the study. * Has hypersensitivity, intolerance, or contraindication to the use of sumatriptan, any of its components, or any other 5-hydroxytryptamine 1 (5-HT1) agonist. * Has a hypersensitivity, intolerance, or contraindication to the use of naproxen, any of its components, or any other non-steroidal anti-inflammatory drug including aspirin and cyclooxygenase-2 (COX-2) inhibiting agents. * Is currently taking a migraine prophylactic medication containing an ergotamine or ergot derivative such as dihydroergotamine (DHE) or methysergide. * Has taken, or plans to take, a monoamine oxidase inhibitor (MAOI) including herbal preparations containing St. John's wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment. * Has taken or plans to take an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) anytime within the 2 weeks prior to screening through 48 hours post final study treatment. * Has received any investigational agents within 30 days prior to Visit 1. * Plans to participate in another clinical study at any time during this study. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01300546

{ "NCT_ID" : "NCT03995277", "Brief_Title" : "Effect of Biotin on Routine Laboratory Values", "Official_title" : "Investigator-Initiated Study to Evaluate the Effect of Biotin Ingestion On Routine Laboratory Tests", "Conditions" : ["Biotin Ingestion", "Interference With Routine Analyical Tests"], "Interventions" : ["Dietary Supplement: Biotin"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SEQUENTIAL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-01-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-02-22", "Study_Completion_Date(Actual)" : "2019-08-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-06-17", "First_Posted(Estimated)" : 2019-06-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-06-19", "Last_Update_Posted(Estimated)" : 2020-05-22", "Last_Verified" : 2020-05" } }}

#Study Description Brief Summary Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements. Detailed Description Study group 1) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in over-the-counter supplements (10 mg/d) in healthy adults and subjects with thyroid hormone supplementation. Therefore, this study was designed to assess the association of short-term biotin ingestion for 10 days with performance of various analytes based on Roche, Abbott and Siemens assays. Study group 2) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in multivitamin supplements (biotin = 50 µg/d) in healthy adults. Therefore, this study was designed to assess the association of short-term biotin ingestion for 20 days with performance of various analytes based on Roche, Abbott and Siemens assays. #Intervention - DIETARY_SUPPLEMENT : Biotin - Daily intake of 10 mg or 50 µg per day

#Eligibility Criteria: Inclusion Criteria: * Age above 18 years * Apparently healthy Exclusion Criteria: * Pre-existing condition other than hypothyroidism * Intake of dietary supplements containing biotin 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

NCT03995277

{ "NCT_ID" : "NCT03453411", "Brief_Title" : "Effects of EMONO in Children During Dental Care", "Official_title" : "Multicentre, Prospective, Uncontrolled Study to Describe the Present, Felt and Sought Effects of EMONO in Children During Dental Care", "Conditions" : ["Dental Care"], "Interventions" : ["Other: Non interventional study"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-05-17", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-06-24", "Study_Completion_Date(Actual)" : "2020-06-24}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-02-26", "First_Posted(Estimated)" : 2018-03-05" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-03-02", "Last_Update_Posted(Estimated)" : 2021-03-25", "Last_Verified" : 2018-02" } }}

#Study Description Brief Summary The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The Investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential. Detailed Description Some narcotic drugs and psychotropic drugs associated with a risk of misuse or identified dependence and are, moreover, the object of a reinforced surveillance. This is the case of EMONO (Equimolar Oxygen and Nitrogen Protoxide Mix), which is part of the ANSM (French National Agency for Medicines and Health Products Safety) list of drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide (also called laughing gas). He has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use. Since 2009, a modification of its MA has enabled the release of the hospital reserve, EMONO can now be used in city medicine and dental surgery. The ANSM has made its provision outside health facilities conditional on the implementation of a common national RMP, accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes. The use of EMONO in pediatric dental care is a particular mode of use in a pediatric population in which the administration of EMONO is often the first administration of a psychoactive substance known for its positive effects (euphoria). Health professionals daily observe children, who after care under EMONO, have a strong appetite for EMONO and claim for any intervention. It would be necessary to understand why, and to estimate the number of children involved. Do children feel positive effects during these actions, which could lead to a wish to prolong the contact with the gas, in search of an effect other than therapeutic? The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential. #Intervention - OTHER : Non interventional study - Non interventional study

#Eligibility Criteria: Inclusion Criteria: * Children aged 3 to 15, requiring care under MEOPA Exclusion Criteria: * Do not fit into the inclusion criteria 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

NCT03453411

{ "NCT_ID" : "NCT02553148", "Brief_Title" : "Estimating the Global Need for Palliative Care for Children", "Official_title" : "Estimating the Global Need for Palliative Care for Children: A Cross Sectional Analysis", "Conditions" : ["Cancer", "Congenital Anomalies", "Cardiovascular Disease", "HIV"], "Interventions" : ["Other: Need for children's palliative care"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-09", "Study_Completion_Date(Actual)" : "2015-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2015-08-19", "First_Posted(Estimated)" : 2015-09-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2015-09-16", "Last_Update_Posted(Estimated)" : 2016-02-23", "Last_Verified" : 2016-02" } }}

#Study Description Brief Summary A cross-sectional analysis of prevalence data from a stratified sample of 23 countries used to estimate the global need for palliative care for children aged 0-19 years. Prevalence data, from the Institute for Health Metrics and Evaluation, was for 12 major diagnostic groups needing children's palliative care according to WHO and UNICEF guidelines. Detailed Description There is growing awareness that there are major gaps in access to children's palliative care (CPC) worldwide. Adults have a greater likelihood of receiving palliative care than children. Growing access to treatment services, and extended periods of wellness have led to some changes in the nature of the palliative care services required. Children are more resilient and more likely to require CPC for longer periods than adults. It is against this background that UNICEF and the International Children's Palliative Care Network (ICPCN), in collaboration with national palliative care associations, began a joint analysis to develop methods to assess critical needs and gaps in CPC. The initial assessment, conducted in Kenya, South Africa and Zimbabwe, aimed to analyse existing secondary data on palliative care to estimate the palliative care need amongst children and explore key gaps in the response with service providers. A report on this research, the methods used, and the results for South Africa was published in 2014. There is a lack of information regarding the actual need for palliative care for children, and assessment is a complicated process, due to uncertainty about the patient population and the nature of palliative care for children. Although there have been some studies focusing on the status of CPC in sub-Saharan Africa and the United Kingdom, there are differences in the scope and approach to the present study. A systematic review of the provision of CPC around the world, noted that over 65% of countries have no recognised CPC service provision, and concluded that service provision for CPC is not meeting the need in the majority of the world. Generally, studies estimating need for palliative care for children are based on mortality statistics for chronic, incurable illnesses. Estimates focused on end-of-life care, as in the Global Atlas of Palliative Care at the End of Life do not account for the children that need palliative care well before the last year of life and underestimate the need. The World Health Organization defines palliative care for children as a special, albeit closely related field to adult palliative care. An effort to define the many diseases and conditions requiring CPC a directory was published in 2013 with 376 potential diagnostic labels though the majority of deaths were from a small number. #Intervention - OTHER : Need for children's palliative care - Need for children's palliative care

#Eligibility Criteria: Inclusion Criteria: * have one of the conditions above Exclusion Criteria: * greater than 19 years Sex : ALL Ages : - Maximum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT02553148

{ "NCT_ID" : "NCT01556932", "Brief_Title" : "Randomized Trial of the Effectiveness of Topical 'ABH Gel' vs. Placebo in Cancer Patients With Nausea", "Official_title" : "A Randomized Trial of the Effectiveness of Topical 'ABH Gel' (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) Versus Placebo in Patients With Nausea", "Conditions" : ["Nausea", "Vomiting"], "Interventions" : ["Drug: ABH gel", "Other: placebo"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-05", "Study_Completion_Date(Actual)" : "2014-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-03-13", "First_Submitted_that_Met_QC_Criteria" : 2015-10-15", "First_Posted(Estimated)" : 2012-03-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-03-16", "Last_Update_Posted(Estimated)" : 2015-10-16", "Last_Verified" : 2015-10" } }}

#Study Description Brief Summary This randomized clinical trial studies ABH (lorazepam, diphenhydramine hydrochloride, and haloperidol) gel in patients with nausea. ABH gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting. The general purpose of this research study is to improve the treatment of nausea and vomiting. Detailed Description PRIMARY OBJECTIVES: I. The primary outcome is the change in numeric rating scale in self-reported nausea on a 0-10 scale from baseline to 60 minutes of treatment. OUTLINE: All individuals who are eligible are randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. The randomization list will be generated by the Study Biostatistician. Neither the patient nor the investigator will have knowledge of the actual content of Drug A or B, so the study will be double-blinded, and placebo controlled. Drug A: The dose of the drugs in the 1.0 mL dose will be 2 mg of lorazepam, 25 mg of diphenhydramine, and 2 mg of haloperidol in a pluronic lecithin organogel. It will be rubbed on the volar surface of the wrists by the subject, for 2 minutes as done in clinical practice, at time 0. Drug B: equivalent but no ABH. Subjects will rub 1 mL of the first drug, Drug A gel, between their wrists for 2 minutes. Subjects will be asked to rate and complete their nausea on the Memorial Symptom Assessment Scale (CMSAS). At time 60 two options can occur. One, if there is no effect after the first drug in one hour, then patients will receive the second drug. If there is no effect in one hour from second drug, patients will stop the study and resume normal treatment for their nausea. Or two, if the first gel reduces nausea by more than 1 point on the 0-10 scale, subjects will wait 4 hours to apply the next gel. At this point, the study procedures will be repeated. After treatment, patients are followed up for up to 8 hours. Subjects will be asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale at baseline, 60, 120, 180, and 240 minutes. Subjects will complete the Memorial Symptom Assessment Scale (CMSAS), a reliable and valid instrument for assessing relevant symptoms including lack of energy, lack of appetite, pain, dry mouth, weight loss, feeling drowsy, shortness of breath, constipation, difficulty sleeping, difficulty concentrating, and nausea. #Intervention - DRUG : ABH gel - Given topically - Other Names : - Ativan, lorazepam, diphenhydramine hydrochloride, Benadryl, Bendylate, Eldadryl, SK-Diphenhydramine, haloperidol, Haldol, McN-JR-1625, R-1625 - OTHER : placebo - Given topically - Other Names : - PLCB

#Eligibility Criteria: Inclusion Criteria: * English speaking * No allergies to the drugs * Able to complete the forms * If a woman of childbearing age, agree to use contraception; women will be offered a pregnancy test before doing the trial if they request one, as stated in the Informed Consent Form * Patients must have a self reported nausea score of at least 4 on a numeric rating scale of 0 <= age <= 10 (zero being no nausea and ten being the worst possible nausea); patients are not required to have vomiting * Patients must have had or have cancer, or have had a consultation with the palliative care team * They must not have had any changes to their nausea program within the past 12 hours, if on anti-emetics * Patients must not have received chemotherapy within 5 days, unless it is a stable oral chemotherapy drug such as capecitabine (Xeloda), erlotinib (Tarceva), or similar Exclusion Criteria: * History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age) * Use of any medication that would contraindicate benzodiazepine administration * Pregnant or nursing * Children Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT01556932

{ "NCT_ID" : "NCT01781728", "Brief_Title" : "Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma", "Official_title" : "Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma", "Conditions" : ["Pancreatic Cancer", "Periampullary Adenocarcinoma"], "Interventions" : ["Radiation: Stereotactic Body Radiation Therapy (SBRT)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-01", "Study_Completion_Date(Actual)" : "2024-06-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-08-08", "First_Submitted_that_Met_QC_Criteria" : 2024-10-08", "First_Posted(Estimated)" : 2013-02-01" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-01-30", "Last_Update_Posted(Estimated)" : 2024-10-10", "Last_Verified" : 2024-10" } }}

#Study Description Brief Summary The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma. Detailed Description No standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). Linac based stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. We hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using Linac based SBRT delivered as 5 Gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity. #Intervention - RADIATION : Stereotactic Body Radiation Therapy (SBRT) - Stereotactic Body Radiation Therapy (SBRT) which included 5 consecutive fractions of 25 to 33 Gy, following 3 months of multiagent chemotherapy.

#Eligibility Criteria: Inclusion Criteria: * 18 years or older * Karnofsky Performance Status greater than or equal to 70% * confirmed pancreatic or periampullary adenocarcinoma * pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension * Either: * standard of care treatment for pancreatic cancer that included radiation therapy * patients may be receiving continued chemotherapy post initial CRT. or * standard of care treatment for pancreatic cancer that did not include radiation therapy * patients must have attempted chemotherapy upon initial diagnosis * acceptable organ and marrow function as determined by blood tests * ability to understand and give consent * must be a patient to be treated with SBRT only at Johns Hopkins Hospital * life expectancy of greater than 3 months Exclusion Criteria: * extensive metastatic disease * performance status of less than 70 * children are excluded form the study * no uncontrolled intercurrent illness * no concurrent malignancy other than melanoma * pregnant or breast feeding women are excluded * women who are not post-menopausal and have a positive pregnancy test * life expectancy of less than 3 months 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

NCT01781728

{ "NCT_ID" : "NCT04754828", "Brief_Title" : "A Study of Bedside Versus Hallway Rounding", "Official_title" : "A Study of Bedside Versus Hallway Rounding for Neurology Inpatient Teams", "Conditions" : ["Education, Medical"], "Interventions" : ["Other: Assigned to a rounding style"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-02-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-03-31", "Study_Completion_Date(Actual)" : "2020-03-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-02-05", "First_Posted(Estimated)" : 2021-02-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-02-11", "Last_Update_Posted(Estimated)" : 2021-02-15", "Last_Verified" : 2021-02" } }}

#Study Description Brief Summary The purpose of this study is to compare bedside rounding with hallway and conference room rounding on the neurology inpatient ward service at an academic hospital and identify best practices associated with educational and patient care outcomes. Specifically, this study will determine which rounding practices are associated with a positive educational experience for learners, greatest patient and care team communication, and time efficiency. Detailed Description This study will evaluate the efficacy of bedside rounding and compare it to hallway and conference room rounding on the neurology ward service at the Brigham and Women's Hospital (BWH). The neurology ward service consists of two teams, each with 10-15 vascular neurology and general neurology patients. The teams perform daily attending rounds. Each team consists of an attending physician, a senior supervisory resident, two junior residents, several rotating residents and interns from other departments, medical students, as well as a physician assistant who alternates daily between the teams. Neurology attendings spend two weeks at a time on a team. During a two-week attending rotation, we plan to designate one of the teams as the 'bedside rounding team' and the other team as the 'hallway rounding team', which will serve as the control group. The bedside rounding team will carry out patient presentations at the bedside, with a focus on the patient, while ensuring nursing involvement in each patient's room. The hallway rounding team ('the usual method') will present patients outside of the patient's room, without an added emphasis on nurse participation. Halfway through the two-week rotation, the team designation will switch in a crossover fashion, so that the initial bedside rounding team will become the hallway rounding team, and vice versa. Our planned study period is Monday through Friday for a consecutive 6-8 week period, and we anticipate including about 150-200 patients in our study. To evaluate staff educational experience, patient and interprofessional communication, and clinical care outcomes of these two rounding approaches, we plan to survey patients, resident trainees, attendings, and nurses on both teams. For collection of data, a student observer or research assistant familiar with the study purpose and methods will accompany a neurology team during weekday morning rounds and record data about the composition and timing of rounds. Eligible participants include adult patients and providers (nurses; physicians, including residents and attendings; and ancillary providers) involved in the inpatient neurology service at BWH. Patients whose primary language is English will be included in the study with notation of this feature. Observations will focus on activities of the physician providers. Surveys for medical education will involve physician participants who give consent. Surveys of patient care and communication will involve patients and nurses who give consent. #Intervention - OTHER : Assigned to a rounding style - Team rounded on new admissions either in hallway or at the bedside

#Eligibility Criteria: Inclusion Criteria: * new admission to neurology team Exclusion Criteria: * comfort measures as sole treatment goal 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

NCT04754828

{ "NCT_ID" : "NCT05499845", "Brief_Title" : "Effects of Different Anesthesia on Odor Memory", "Official_title" : "Comparison of the Effects of TIVA and Inhalation Anesthesia Methods on Olfactory Functions and Olfactory Memory", "Conditions" : ["Smell Functions", "Odor Memory"], "Interventions" : ["Diagnostic Test: butanol threshold test and smell identification tests"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-01-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-06-30", "Study_Completion_Date(Actual)" : "2013-07-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-06-02", "First_Posted(Estimated)" : 2022-08-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-08-11", "Last_Update_Posted(Estimated)" : 2022-08-12", "Last_Verified" : 2022-08" } }}

#Study Description Brief Summary This study aimed to research the effect of different general anesthesia administration on postoperative smell functions and memory. #Intervention - DIAGNOSTIC_TEST : butanol threshold test and smell identification tests - no additional intervention

#Eligibility Criteria: Inclusion Criteria: * American Society of Anesthesiologists (ASA) I-II risk groups * operated under elective conditions with general anesthesia requiring intubation * operation durations of 40 <= age <= 180 minutes. Exclusion Criteria: * intracranial, * endocrine or nasal surgery, * pregnant cases, * those with history of respiratory tract diseases and psychiatric disease, with disorder of odor reception and perception, * with smoking and chronic alcohol use, * requiring a nasogastric probe 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

NCT05499845

{ "NCT_ID" : "NCT02003612", "Brief_Title" : "Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia", "Official_title" : "An Analysis of Historical Data on Hematological Remission and Survival Among Adult Patients With Relapsed / Refractory B-Precursor Acute Lymphoblastic Leukemia", "Conditions" : ["Acute Lymphoblastic Leukemia"], "Interventions" : ["Other: Not applicable - observational study"], "Location_Countries" : ["France", "United States", "Poland", "Germany", "Spain", "Italy", "Czechia", "United Kingdom"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-10-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-01-10", "Study_Completion_Date(Actual)" : "2014-04-28}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-12-02", "First_Posted(Estimated)" : 2013-12-06" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-12-02", "Last_Update_Posted(Estimated)" : 2022-11-07", "Last_Verified" : 2022-11" } }}

#Study Description Brief Summary A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients. Detailed Description A retrospective observational study reviewing historical survival data (hematological remission and survival) for adult patients who have either relapsed or refractory B-precursor acute lymphoblastic leukemia. Data are aggregated across multiple countries and study sites in the EU and US #Intervention - OTHER : Not applicable - observational study - No intervention exists as this is a retrospective observational study

#Eligibility Criteria: Inclusion Criteria: * adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia * age >= 15 years at time of de novo (initial) diagnosis of acute lymphoblastic leukemia * initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later * No CNS involvement at relapse * No isolated extramedullary relapse * Other inclusion criteria may apply Sex : ALL Ages : - Minimum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT02003612

{ "NCT_ID" : "NCT04548349", "Brief_Title" : "Profiling the Skin Microbiome in Response to Altreno in Acne Patients", "Official_title" : "Profiling the Skin Microbiome in Response to Altreno in Acne Patients", "Conditions" : ["Acne", "Healthy"], "Interventions" : ["Drug: Altreno", "Drug: Benzoyl peroxide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "OTHER", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-04-23", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-08-22", "Study_Completion_Date(Actual)" : "2022-08-22}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-07-20", "First_Submitted_that_Met_QC_Criteria" : 2024-02-03", "First_Posted(Estimated)" : 2020-09-14" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-09-09", "Last_Update_Posted(Estimated)" : 2024-02-06", "Last_Verified" : 2024-02" } }}

#Study Description Brief Summary The study objective is to characterize the shift in the diversity and abundance of the skin microbial community at baseline and in response to Altreno monotherapy as compared to benzoyl peroxide (BPO) 2.5% leave-on gel monotherapy in acne patients. Detailed Description With the advent of 16S rRNA sequencing, scientific community is beginning to understand the critical importance of the microbiome in human health. In dermatology, researchers have begun to lead the effort to not only better understand how the microbiome contributes to the pathogenesis of skin disease, but also harness its power to develop novel therapies. Acne is a common inflammatory skin disorder. P. acnes on the skin has been traditionally thought of as the culprit bacteria in the pathogenesis of acne. Recent studies demonstrate that the skin microbial composition dynamically changes in response to systemic acne therapy. Using 16 rRNA gene sequencing, a prior study has confirmed that systemic antibiotic treatment decreased the abundance of P. acnes, which returned to baseline after discontinuation of the therapy. In contrast, the systemic therapy increased the abundance of Pseudomonas species, which returned to baseline after therapy cessation. Based on the opposing response to the therapy, it can be speculated that these two species compete for the same microenvironment within the skin microbiome. Interestingly, the same systemic therapy decreased the abundance of lactobacillus genus, the 'good bacteria' that is protective against skin infection, and that decrease was sustained even after cessation of the therapy. Similarly, another study has demonstrated that systemic isotretinoin therapy disturbed the skin microbiome in acne patients with increased bacterial diversity on the cheeks. It is unclear the potential therapeutic role of the increased bacterial diversity in the management of acne patients. The study aims to characterize the shift in the diversity and abundance of the skin microbial community in response to Altreno in acne patients. Understanding the role of the skin microbiome in response to therapy can help clinicians to develop tailored, targeted treatment options, including reconstitution of 'good bacteria.' Furthermore, it can lead to development of novel topical pre and probiotics. #Intervention - DRUG : Altreno - Acne patients will be assigned to Altreno once daily. - DRUG : Benzoyl peroxide - Acne patients will be assigned to BPO leave-on gel once daily.

#Eligibility Criteria: Inclusion Criteria: * A confirmed diagnosis of acne that warrants initiating topical medications. * Denies use of any prescribed systemic acne treatments in the past 30 days. * Denies use of any prescribed topical medications in the past 30 days. * Denies use of any OTC topical acne medications in the past 14 days. * Denies use of any emollients in the past 24 hours (if feasible). * Denies bathing or facial washing in the past 12 hours (if feasible). * Willingness to adhere to the recommended topical regimen during the duration of the study. Exclusion Criteria: * Women who are pregnant, breastfeeding, or planning to get pregnant during the study. * Use of any investigational drug(s) in the past 3 months. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT04548349

{ "NCT_ID" : "NCT03474939", "Brief_Title" : "The Effect of Midazolam Premedication on Copeptine Concentration in Blood", "Official_title" : "The Effect of Midazolam Premedication on Copeptine Concentration in Blood", "Conditions" : ["Preanesthetic Medication", "Copeptin"], "Interventions" : ["Drug: Midazolam Oral Tablet", "Other: Placebo Oral Tablet"], "Location_Countries" : ["Poland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-04-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03-01", "Study_Completion_Date(Actual)" : "2019-03-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-03-16", "First_Posted(Estimated)" : 2018-03-23" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-03-16", "Last_Update_Posted(Estimated)" : 2019-04-19", "Last_Verified" : 2019-04" } }}

#Study Description Brief Summary The study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood. #Intervention - DRUG : Midazolam Oral Tablet - Midazolam Oral tablet - OTHER : Placebo Oral Tablet - Glucose 1000mg tablet night before surgery and 60 minutes before surgery

#Eligibility Criteria: Inclusion Criteria: * Patients scheduled for elective surgery * Patients with no chronić illness and considered ASA 1 by anesthesiologist * Patients with mild and controlled chronic illness considered ASA 2 by anesthesiologist Exclusion Criteria: * Patient refusal * Chronic illness requiring intense treatment or uncontrolled illness (ASA 3 or more) 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

NCT03474939

{ "NCT_ID" : "NCT03722602", "Brief_Title" : "Body Composition of People After a Stroke", "Official_title" : "Effect of Rehabilitation on the Body Composition in Patients With Stroke", "Conditions" : ["Rehabilitation", "Stroke", "Body Composition"], "Interventions" : ["Other: Standard rehabilitation after stroke"], "Location_Countries" : ["Poland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-03", "Study_Completion_Date(Actual)" : "2017-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-05-22", "First_Posted(Estimated)" : 2018-10-29" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-10-24", "Last_Update_Posted(Estimated)" : 2018-10-30", "Last_Verified" : 2018-10" } }}

#Study Description Brief Summary The study enabled assessment of changes in body mass composition, metabolic syndrome and lipid profile in patients after stroke, following rehabilitation in hospital. Detailed Description Stroke is estimated to affect 24-54% of the global population and is one of the leading causes of death. According to World Health Organization over one billion people worldwide are overweight, and approximately 300 million people are obese. The main factors contributing to this situation include insufficient physical activity and unhealthy diet. Among the major consequences of obesity in adults one can distinguish metabolic syndrome and cardiovascular diseases. Therefore, measurements were performed to identify changes in body mass composition (body fat, visceral fat level, muscle mass, total body water, metabolic syndrome, lipid profile) in subjects after stroke following rehabilitation at hospital. The study was carried at the Clinical Rehabilitation Ward with Early Neurological Rehabilitation Unit, at the Clinical Hospital in Rzeszów, Poland. The measurements were performed from June 2015 to March 2017. During that time the total of 1,143 patients received treatment and rehabilitation at the clinic. These included 403 patients after stroke. The subjects were examined three times. In accordance with inclusion and exclusion criteria 128 subjects were qualified for the first exam. The second exam took into account 114 subjects and finally 100 patients with stroke participated in the third exam. The analyses took into account the data obtained from the 100 subjects who took part in all the exams. Body mass composition was assessed in all the subjects with Tanita MC 780 MA analyzer, whose operation is based on Bioelectrical impedance analysis (BIA). The subjects' height was measured with the stadiometer PORTSTAND 210. Rehabilitation outcome was assessed with Barthel index, Berg scale, Ashworth scale, Brunnström scale, Rankin scale and symmetry index for lower limb weight distribution (Ws). In addition, waist and hip circumference were measured and WHR was calculated. The above parameters were assessed three times: Exam I took place upon admission to hospital Exam II on the day the patient was discharged from hospital Exam III was performed 12 weeks after discharge from hospital during a follow-up visit. The follow-up visit, 12 weeks after discharge from hospital, was meant to determine whether the effects of rehabilitation persisted for 12 weeks after discharge from hospital. Other parameters examined included: LDL, HDL, total cholesterol, TG, atherogenic index, CRP, and serum glucose level. Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic. The test was performed twice: upon admission to the Clinic and following 5-week rehabilitation at the hospital. #Intervention - OTHER : Standard rehabilitation after stroke - The program of the rehabilitation was designed specifically for each patient. It was prepared to match the patient's functional status and the defined goals. The subjects participated in exercise five days per week, for five weeks. During their stay at the Clinic, the patients took part in morning exercise and received individual practice, based on neuro-developmental treatment (Bobath concept), and proprioceptive neuromuscular facilitation (PNF) method, addressing the impaired motor abilities; if it was needed they also performed exercise based on equipment using biological feedback: Balance Trainer (static and dynamic parapodium) and Pablo system designed for upper limb training.

#Eligibility Criteria: Inclusion criteria: * Stroke experienced. * Ability to stand without assistance. * Ability to walk without aid. * No impairments in higher mental functions * Patient's informed, voluntary consent to participate in the study. Exclusion criteria: * Lack of patient's consent to participate in the study * Lack of ability to stand without assistance. * Ischemic lesion located in the cerebellum and brain stem. * Metal, electronic implants. * Epilepsy. * Pregnancy. * Menstruation, in females. * Limb injuries incurred following stroke onset, prior to the exam. 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

NCT03722602

{ "NCT_ID" : "NCT06633965", "Brief_Title" : "Safety and Feasibility Testing of a Smaller Network Version of AIDANET", "Official_title" : "Safety and Feasibility Testing of a Smaller Network Version of AIDANET (MiniNET)", "Conditions" : ["Type 1 Diabetes"], "Interventions" : ["Device: AIDANET"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2024-11-20", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-12-16", "Study_Completion_Date(Actual)" : "2024-12-18}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2024-10-04", "First_Posted(Estimated)" : 2024-10-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2024-10-07", "Last_Update_Posted(Estimated)" : 2025-01-09", "Last_Verified" : 2025-01" } }}

#Study Description Brief Summary A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D). Detailed Description The study will be performed for about 36 hours at a local hotel. Following the hotel session, participants will undergo a 7 day/6-night Remote Monitored At-Home use session. A one-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy will also be completed. Participants will be randomized 1:1, to either Group A (control period prior to AIDANET use) or Group B (control period after AIDANET use). #Intervention - DEVICE : AIDANET - AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions. - Other Names : - Group B - DEVICE : AIDANET - AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions. - Other Names : - Group A

#Eligibility Criteria: Inclusion Criteria: * Age >=18.0 and <=60 years at time of consent * Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year * Currently using insulin pump for at least three months; Any pump, either open loop or hybrid closed loop may be used. * Currently using insulin for at least six months. * Willingness to switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team. * Currently using a Dexcom G6 or G7 CGM. * Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency. * Participant not currently known to be pregnant or breastfeeding. * If participant capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. * Willingness to use the study FCL system (CGM, pump, and phone) during the relevant study period. * Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial. * Willingness to participate in all study procedures including the house/hotel session, exercise challenges (e.g., one hour per day during hotel), and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session. * Access to internet at home and willingness to upload data during the study as needed. * Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol. * Participant is proficient in reading and writing English. Exclusion Criteria: * Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month. * Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA. * Hemophilia or any other bleeding disorder. * History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months. * History of DKA event in the last 12 months. * History of chronic renal disease (Stage 4 or unstable Stage 3b per investigator judgment) or currently on peritoneal or hemodialysis. * History of adrenal insufficiency. * Currently being treated for a seizure disorder. * Hypothyroidism or hyperthyroidism that is not adequately treated. * Coronary artery disease or other heart condition that would prevent participation in moderate intensity exercise. * Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks. * Planned surgery during the study period. * Known ongoing adhesive intolerance that is not well managed. * A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. * Participation in another interventional trial at the time of enrollment. * Participant with a direct supervisor involved in the conduct of the trial. 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

NCT06633965

{ "NCT_ID" : "NCT05414422", "Brief_Title" : "A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD", "Official_title" : "A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of Intravenous PCN-101 in Treatment Resistant Depression", "Conditions" : ["Treatment Resistant Depression"], "Interventions" : ["Drug: PCN-101", "Drug: Placebo"], "Location_Countries" : ["Poland", "Germany", "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)" : "2022-02-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-11-10", "Study_Completion_Date(Actual)" : "2022-11-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-05-27", "First_Submitted_that_Met_QC_Criteria" : 2024-05-10", "First_Posted(Estimated)" : 2022-06-10" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-06-08", "Last_Update_Posted(Estimated)" : 2024-06-04", "Last_Verified" : 2022-12" } }}

#Study Description Brief Summary This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks \[Day -15 to Day -2\]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment \[Day 1\]), and post-treatment follow-up (7 and 14 days after infusion on Days 8 and 15, respectively). A total of 93 adult subjects with TRD will be randomly allocated in equal cohorts of 31 subjects/arm to the 3 arms of the study in a blinded manner. #Intervention - DRUG : PCN-101 - Concentrate for solution for infusion - Other Names : - R-ketamine - DRUG : Placebo - Concentrate for solution for infusion

#Eligibility Criteria: Inclusion Criteria: * Capable of giving and give signed informed consent * Weigh >= 50 kg and have a body mass index >= 18 and <= 35 * Diagnosis of recurrent major depressive disorder (MDD) without psychotic features per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), confirmed by Mini-International Neuropsychiatric Interview * Hamilton Depression Rating Scale total score > 20 * Inadequate response to at least 2 antidepressants in the current episode of depression that were given for >= 6 weeks * Stable oral antidepressant treatment without dose change for at least 30 days Exclusion Criteria: * History of, or current signs and symptoms of diseases or conditions that would make participation not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments * History of moderate or severe head trauma or other neurological disorders, neurodegenerative disorder or systemic medical diseases that are in the opinion of the Investigator likely to interfere with the conduct of the study or confound the study assessments * Has a primary DSM-V diagnosis of current (active) MDD with psychotic features, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa. * Has a current of prior DSM-V diagnosis of a primary psychotic disorder, bipolar or related disorders, intellectual or autism spectrum disorder, or borderline personality disorder * Has any significant disease or disorder that in the opinion of the investigator, may either put the subject at risk because of participation in the study, influence the results of the study, or affect the subject's ability to participate in the study * Has uncontrolled hypertension, despite medication, at Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg or any past history of hypertensive crisis. * Has an abnormal ECG of clinical relevance at screening or baseline * Has known history of, or positive serology for human immunodeficiency virus, hepatitis B surface antigen, hepatitis C infection * Has a history of malignancy within the 5 years prior to screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy that in the opinion of the investigator, with concurrence with the Sponsor's Medical Monitor, is considered to have minimal risk of recurrence) * Has homicidal ideation/intent per the Investigator's clinical judgment, or has suicidal ideation with some intent to act within 1 month prior to the start of screening per the Investigator's clinical judgement or based on the C-SSRS, or a history of suicidal behavior within the past year prior to the start of the screening/prospective observational phase * Has had major surgery within the 4 weeks before screening, or will not have fully recovered from surgery or planned surgery during the time the subject is expected to participate in the study * Has moderately impaired hepatic function at screening, defined as serum alanine aminotransferase or aspartate aminotransferase > 2 × upper limit of normal or total bilirubin > 2 × upper limit of normal * Has received any disallowed therapies as follows: * Receipt of a known potent inhibitor of hepatic cytochrome P450 (CYP) 2B6, or CYP3A, activity within 1 week or within a period 5 times the drug's half-life, whichever is longer, before the first administration of study drug on Day 1 * Treatment with a disallowed antipsychotic within the past 30 days prior to screening, except subjects who are on stable doses of quetiapine, aripiprazole, brexpiprazole, or olanzapine prescribed as adjunct treatment for depression (without psychosis) may be included in the study * Any changes in psychotropic medication type or dose within the past 30 days prior to screening * Treatment with monoamine oxidase inhibitors currently or within the past 30 days of screening * Doses of oral contraception should not contain more than 30 micrograms of ethinyl estradiol per day * Has initiated psychotherapy or acupuncture acupuncture within the past 90 days of screening. Patients planning to initiate individual or group therapy during the study are also not eligible * Has received electroconvulsive therapy, transcranial magnetic stimulation, vagal nerve stimulation, deep brain stimulation, or other brain stimulation treatment within the past 4 weeks or currently used as either an acute or maintenance treatment of depression * Has received any IP within 30 days or 5 half-lives * Has a history of substance abuse (drug or alcohol) or dependence (except nicotine or caffeine) within the previous 6 months prior to the screening visit * Has a history of previous nonresponse to ketamine, R-ketamine or S-ketamine, or has received 8 or more doses of ketamine, R-ketamine or S-ketamine in their lifetime * Has a previous history of intolerance to ketamine, R-ketamine, or S-ketamine * History of abuse of ketamine, R-ketamine, S-ketamine, or phencyclidine * Subjects should not consume grapefruit, grapefruit juice, or Seville orange related products for 72 hours before IP administration and throughout the study * Has the presence of clinically relevant long-term COVID-19 symptoms. Has current signs or symptoms of COVID-19 * COVID-19 vaccination is allowed as long as the doses are administered >= 30 days before study drug administration; vaccination is not allowed during the course of the study Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05414422

{ "NCT_ID" : "NCT05923242", "Brief_Title" : "Translating ECHOS2 Into an mHealth Platform", "Official_title" : "Evaluation of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2) Pilot Intervention: Translating ECHOS Into an mHealth Platform", "Conditions" : ["Childhood Cancer", "Cardiac Toxicity", "Pediatric Cancer"], "Interventions" : ["Behavioral: Computerized Intervention Authoring Software (CIAS)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2023-07-05", "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" : 2023-06-19", "First_Posted(Estimated)" : 2023-06-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-06-19", "Last_Update_Posted(Estimated)" : 2024-01-11", "Last_Verified" : 2024-01" } }}

#Study Description Brief Summary Childhood cancer survivors are at an increased risk of cardiac toxicity due to prior anti-cancer therapy. However, adherence to cardiac screening in this population remains low. This study aims to assess the feasibility of an mHealth motivational interviewing platform called Computerized Authoring Intervention Software (CIAS) in childhood cancer survivors. Participants will be recruited from the Childhood Cancer Survivorship Study. #Intervention - BEHAVIORAL : Computerized Intervention Authoring Software (CIAS) - CIAS is a web based intervention. The CIAS tool walks the participant through a Motivational Interviewing process whereby they think through the reasons for and against completing screening. CIAS makes use of an automated avatar (Emmi) who is programed to ask them questions and lead them through several topic areas related to screening. The CIAS pathways include options for participants to request a link of resources after they complete each session and for patients to request a list of the cancer treatments listed in their study records in order to confirm their understanding of their cancer history.

#Eligibility Criteria: Inclusion Criteria: * 18 years or older * Diagnosed with cancer at age 17 or younger * 2 or more years after completion of cancer therapy * Receipt of cardiotoxic therapy (Any dose of anthracycline or 15 Gy chest radiation involving cardiac structures) * No history of cardiomyopathy * Have not received an echocardiogram in the past 5 years 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

NCT05923242

{ "NCT_ID" : "NCT04462627", "Brief_Title" : "Reduction of COVID 19 Transmission to Health Care Professionals", "Official_title" : "Reduction of COVID 19 Transmission to Health Care Professionals", "Conditions" : ["COVID 19"], "Interventions" : ["Diagnostic Test: Blood group determination", "Diagnostic Test: Antibody titration", "Dietary Supplement: Probiotic"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-04-14", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-04-11", "Study_Completion_Date(Actual)" : "2022-04-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-07-07", "First_Posted(Estimated)" : 2020-07-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-07-07", "Last_Update_Posted(Estimated)" : 2022-07-20", "Last_Verified" : 2022-07" } }}

#Study Description Brief Summary When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate. The pulmonary epithelial cells of a part of the population, known as 'secretors', are capable of expressing the antigens of the 'ABO' system on their surface. This secretory status can be established by determining the antigens of the Lewis blood group system. When the virus replicates in an 'secreting' individual, the antigens of the 'ABO' system of the infected individual will be present on the surface of the viruses formed in his/her lungs. It was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the 'ABO' system carried by the virus. A patient of group 'O' would thus defend himself much better against a virus carrying antigens of blood group 'A', the natural antibodies 'anti-A' of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. The first data collected in Wuhan (China) seems to confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on the basis of blood groups. In order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the 'ABO' and 'Lewis' blood groups of patients and 'ABO' of nursing staff in health care units, if operational and human conditions allow. #Intervention - DIAGNOSTIC_TEST : Blood group determination - Determination of the blood group (ABO/LE) - DIAGNOSTIC_TEST : Antibody titration - Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton. - DIETARY_SUPPLEMENT : Probiotic - Administration of a probiotic to healthy volunteers to determine if it increases the level of circulating natural anti-A and anti-B antibodies (Probactiol Plus (Metagenics)).

#Eligibility Criteria: Inclusion Criteria: * COVID19 positive patients admitted within the CHU Brugmann 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: Yes

NCT04462627

{ "NCT_ID" : "NCT00567944", "Brief_Title" : "Use of the BrainPort® Balance Device to Improve Balance in Adults With Balance Deficits Due to Stroke", "Official_title" : "A Substitute Vestibular Information System Using the BrainPort® Balance Device for Adults With Chronic Vestibular Dysfunction Following Stroke", "Conditions" : ["Cerebrovascular Accident"], "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)" : "2007-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-04", "Study_Completion_Date(Actual)" : "2010-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-12-03", "First_Posted(Estimated)" : 2007-12-05" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2007-12-03", "Last_Update_Posted(Estimated)" : 2012-06-28", "Last_Verified" : 2012-06" } }}

#Study Description Brief Summary The purpose of this study is to evaluate the safety and efficacy of the BrainPort balance device in improving balance in people with balance deficits due to stroke. Detailed Description Following baseline assessments, subjects participate in 5 consecutive days (10 hours) of clinic training with the BrainPort balance device with a Physical Therapist. Assessments are repeated at the end of clinic training. Following clinic training, subjects take the device home to use for two (2) 20 minute training sessions each day. Subjects return to the clinic for one (1) day of testing after using the device at home for 7 weeks. #Intervention - DEVICE : BrainPort Balance Device - The BrainPort balance device, is a non-invasive medical device that provides head and body position information to a person via their tongue.

#Eligibility Criteria: Inclusion Criteria: * At least 18 years. * Diagnosis of stroke for at least 6 months. * Reached a plateau and been discharged from physical therapy. * Able to ambulate with or without assistance. * Ongoing balance problem. * Able to read and understand the informed consent form, and willing to sign the informed consent form. Exclusion Criteria: * Current oral health problems as determined by health questionnaire and an examination of the oral cavity. * Any medical condition that would interfere with performance on the assessments. * History of seizures. * Pregnancy. * Cognitive deficits (Mini-Mental 25 or below), joint replacements, cervical vertigo, or major neurologic disease, major depression or disabling psychiatric disorder. * Known neuropathies of tongue or skin tactile system. * Prior exposure to BrainPort® balance device. * Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit. * Subjects who have undergone middle ear or other surgery with sacrifice or damage to the chorda tympani nerve, lingual nerve, or hypoglossal nerve. 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

NCT00567944

{ "NCT_ID" : "NCT01137721", "Brief_Title" : "State Of The Art Functional Imaging In Sickle Cell Disease", "Official_title" : "State Of The Art Functional Imaging In Sickle Cell Disease", "Conditions" : ["Sickle Cell Anemia"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-06", "Study_Completion_Date(Actual)" : "2016-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-06-03", "First_Posted(Estimated)" : 2010-06-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-06-03", "Last_Update_Posted(Estimated)" : 2018-08-23", "Last_Verified" : 2016-08" } }}

#Study Description Brief Summary Sickle cell anemia (SCA) is a serious blood disease with blood vessel changes leading to brain injury and stroke. Studies show about 11% of patients with SCA will develop obvious stroke before age 20 years, with children less than 10 years of age especially vulnerable. The main objective of the SCDMR4\[State Of The Art Functional Imaging In Sickle Cell Disease\] trial is to compare the gray matter cerebral blood flow, measured by MRI,\[magnetic resonance imaging\] ASL \[Arterial Spin Labeling\] perfusion before treatment begins and after the appropriate hydroxyurea dosage is reached (\~ one year). Other important objectives of the SCDMR4 trial include describing the effect of hydroxyurea therapy and transfusion therapy on the functional MRI response, diffusion tensor imaging of white matter, brain function, and transcranial Doppler blood velocities. Detailed Description The Primary Objective of the study is to compare the research participant's GM \[Gray Matter\] CBF \[Cerebral Blood Flow\] by ASL \[Arterial Spin Labeling\] techniques before and after reaching a stable hydroxyurea MTD \[Maximum Tolerated Dose\] (12±3 months after starting hydroxyurea). This is an observational study. Participants receive hydroxyurea as part of their standard of care treatment. This study will observe the above measures prior to beginning hydroxyurea and after participants reach the maximum tolerated dose in order to describe the effect of therapy on the participants' functional response.

#Eligibility Criteria: Inclusion Criteria for Pre-Hydroxyurea or Pre-Transfusion Therapy Study Participants: * The diagnosis of HbSS or HbS/ß0-thalassemia * Age: 8.0 -- <19 years Inclusion Criteria for Study Participants for Observation: * The diagnosis of HbSS or HbS/ß0-thalassemia * Age: 8.0 -- <19 years Inclusion Criteria for Study Participants for Family Related Controls: * No diagnosis of HbSS or HbS/ß0-thalassemia * Age: 8.0 -- <19 years Exclusion Criteria for Pre-Hydroxyurea or Pre-Transfusion Therapy Study Participants: * Unable to tolerate the anatomical or fMRI [functional magnetic resonance imaging] without sedation or anesthesia * Currently receiving hydroxyurea therapy or transfusion therapy * Previous stem cell transplant or other myelosuppressive therapy * History of clinical stroke * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent. Exclusion Criteria for Study Participants for Observation: * Unable to tolerate anatomical or fMRI components without sedation or anesthesia * Currently receiving hydroxyurea or transfusion therapy * Previous stem cell transplant or other myelosuppressive therapy * History of clinical stroke * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. Exclusion Criteria for Study Participants for Family Related Controls: * Unable to tolerate anatomical or fMRI components without sedation or anesthesia * Currently receiving hydroxyurea or transfusion therapy * Previous stem cell transplant or other myelosuppressive therapy * History of clinical stroke * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. Sex : ALL Ages : - Minimum Age : 5 Years - Maximum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT01137721

{ "NCT_ID" : "NCT05245422", "Brief_Title" : "Acceptance of a Partially Hydrolyzed Formula", "Official_title" : "Parent And Infant Relief (PAIR): Acceptance of a Partially Hydrolyzed Formula", "Conditions" : ["Fussy Infant (Baby)"], "Interventions" : ["Other: Infant Formula - Intact protein", "Other: Infant Formula - Partially hydrolyzed protein"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-02-28", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-07-14", "Study_Completion_Date(Actual)" : "2023-07-14}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-01-11", "First_Posted(Estimated)" : 2022-02-18" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2022-02-04", "Last_Update_Posted(Estimated)" : 2023-07-27", "Last_Verified" : 2023-07" } }}

#Study Description Brief Summary A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on infant fussiness. Detailed Description A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein (PHP) infant formula on infant fussiness. Formula tolerance and intake, sleep characteristics, stool characteristics, parental quality of life, and medically confirmed adverse events will be compared between i two study groups. #Intervention - OTHER : Infant Formula - Partially hydrolyzed protein - Partially hydrolyzed cow's milk protein - OTHER : Infant Formula - Intact protein - Intact cow's milk protein

#Eligibility Criteria: Inclusion Criteria: * Primary caregiver has reliable access to the internet and a reliable device (such as a computer, tablet, or smartphone) to access mobile apps and be able to view and complete study questionnaires * Singleton birth * 15 to 75 days of age at Visit 1, inclusive (day of birth is considered Day 0) * Gestational age of >=37 to 42 weeks (36 weeks and six days is considered 36 weeks' gestational age) * Birth weight of 2500 g (5 lbs 8 oz) or more * Exclusively receiving an intact protein infant formula (cow's milk-based or plant-based) for 7 days prior to Visit 1 * Answer to question: 'On average, how fussy has your baby been over the past 3 days' is moderately fussy, very fussy, or extremely fussy at Visit 1 * Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period * Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study * Signed informed consent obtained from parent or legal guardian for infant's participation in the study * Signed authorization obtained from parent or legal guardian to use and/or disclose Protected Health Information for infant from birth through the length of the study period Exclusion Criteria: * Infant has been weighed by a health care professional (HCP) and is identified with inadequate weight gain or failure-to-thrive * Diagnosis or suspicion of cow's milk protein allergy by a healthcare professional * Any acute illness within the 3 days prior to Visit 1 * Infant has had immunizations or a surgical procedure within the 3 days prior to or on Visit 1 * Immunizations are planned for the infant during any of the 7 days after Visit 1 * Use of oral, intramuscular or intravenous antibiotics within the 7 days prior to Visit 1 * Infant has had bloody stools (visible to the naked eye) within the 7 days prior to Visit 1 * Infant has been taking medication (prescribed and over-the-counter) for gastrointestinal conditions for any of the 7 days prior to Visit 1 (however, probiotics are allowed) * Infant has a surgical procedure planned during the study period * History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant * History of underlying neurological or organic disease likely to cause fussiness, such as (but not limited to) a doctor's diagnosis of neonatal abstinence syndrome and inflammatory or orthopedic disorders * Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others) Sex : ALL Ages : - Minimum Age : 15 Days - Maximum Age : 75 Days - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT05245422

{ "NCT_ID" : "NCT06091800", "Brief_Title" : "Interleukin 20 and Periodontal Tisuue Destruction", "Official_title" : "Determination of Levels of IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 in Serum and Gingival Crevicular Fluid (GCF) in Peridontally Healthy and Periodontitis Individuals", "Conditions" : ["Periodontitis"], "Interventions" : ["Other: biochemical analysis"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-06-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-06", "Study_Completion_Date(Actual)" : "2023-06-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-10-11", "First_Posted(Estimated)" : 2023-10-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-10-18", "Last_Update_Posted(Estimated)" : 2023-10-19", "Last_Verified" : 2023-10" } }}

#Study Description Brief Summary Periodontitis is an inflammatory disease that causes destruction of periodontal tissues. IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory cytokine associated with various chronic inflammatory disorders. IL-20 has a significant role in the regulation of osteoclastogenesis and osteoblastogenesis. The aim of this study was to evaluate the effect of IL-20 on periodontal destruction. In the study, a total of 60 participants were included, 30 of whom were systemically and periodontally healthy (control group) and 30 of whom were systemically healthy and had periodontitis (periodontitis group). GCF and serum samples were collected from the participants for biochemical analysis. ELISA method was used to determine IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 levels #Intervention - OTHER : biochemical analysis - GCF and serum samples were collected from the participants for biochemical analysis.

#Eligibility Criteria: Inclusion Criteria: * The following criteria were required for inclusion: being systemically healthy, not smoking, not using antibiotics or systemic corticosteroids within the previous three months, not being pregnant or nursing, not having a chronic inflammatory disease, not receiving periodontal therapy within the previous six months, and possessing at least 20 teeth Exclusion Criteria: * smoking, using antibiotics or systemic corticosteroids within the previous three months, pregnant, receiving periodontal therapy within the previous six months Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT06091800

{ "NCT_ID" : "NCT03022526", "Brief_Title" : "CSE v. Epidural for Postpartum Depression", "Official_title" : "Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial", "Conditions" : ["Depression, Postpartum", "Labor Pain"], "Interventions" : ["Procedure: CSE", "Procedure: Epidural", "Drug: Bupivacaine / fentaNYL"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-31", "Study_Completion_Date(Actual)" : "2019-12-31}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-01-11", "First_Submitted_that_Met_QC_Criteria" : 2020-07-24", "First_Posted(Estimated)" : 2017-01-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-01-12", "Last_Update_Posted(Estimated)" : 2020-08-19", "Last_Verified" : 2020-08" } }}

#Study Description Brief Summary The purpose of this pilot prospective randomized control trial is to compare the initiation of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on risk for postpartum depression symptoms. Investigators will randomize women to the receipt of CSE or E during labor, after measuring baseline psychological, psychosocial, and psychophysical factors related to pain and depression. The immediate research goals are to understand whether the association between labor pain and PPD is modifiable through the use of tailored anesthetic techniques. #Intervention - PROCEDURE : CSE - PROCEDURE : Epidural - DRUG : Bupivacaine / fentaNYL

#Eligibility Criteria: Inclusion Criteria: * Nulliparous (no prior childbirth) * Singleton gestation * Third trimester * Healthy pregnancy * English proficiency (surveys validated in English) * Planned vaginal delivery * Planning to use labor epidural analgesia * Term delivery (>= 37.0 weeks) Exclusion Criteria: * Severe maternal disease * Severe fetal disease * Delivery not at term (delivery prior to 37.0 weeks) * Contraindications to neuraxial anesthesia known at the time of enrollment * Cesarean delivery WITHOUT labor * Planning to list infant for adoption * Did not receive epidural analgesia (either CSE or E) for labor Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT03022526

{ "NCT_ID" : "NCT03090958", "Brief_Title" : "AllyQuest: Engaging HIV+ YMSM in Care Through Social Networking and Gamification", "Official_title" : "AllyQuest: Engaging HIV+ YMSM in Care Through Social Networking and Gamification", "Conditions" : ["Hiv", "HIV/AIDS"], "Interventions" : ["Behavioral: AllyQuest"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-08-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-01-03", "Study_Completion_Date(Actual)" : "2017-01-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-03-13", "First_Submitted_that_Met_QC_Criteria" : 2018-05-07", "First_Posted(Estimated)" : 2017-03-27" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-03-20", "Last_Update_Posted(Estimated)" : 2018-07-11", "Last_Verified" : 2017-03" } }}

#Study Description Brief Summary AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ young men who have sex with men (YMSM). The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis. AllyQuest will be an interactive mobile phone intervention for HIV+ YMSM that utilizes social networking, game-based mechanics and a story-based framework to guide behavior change. Grounded in Social Cognitive Theory, narrative communication and the principles of persuasive technology, the intervention is designed to capitalize on social involvement as a means through which HIV+ YMSM can receive information and social support, experience social norms and reflective appraisals, and feel a sense of connectedness to peers. Detailed Description Specific Aim 1 Design and develop AllyQuest a novel theory-based mobile health (mHealth) intervention for newly diagnosed HIV+ YMSM. Using an iterative research design the investigators will work with our YABs and Ayogo, a global leader in the application of game psychology and health behavior change, to develop and tailor the intervention content for maximal relevance and usability for newly diagnosed HIV+ YMSM. The investigators will use content within existing evidence based interventions(EBIs) developed for persons living with HIV, including MSM and youth to develop the informational content to be delivered in AllyQuest. Activities from the EBIs will be translated into the daily activities that participants within AllyQuest receive. To maximize intervention appeal and appropriateness for our target population, the investigators will convene two youth advisory boards (YABs) to provide insight and feedback during the intervention development process. The investigators will recruit 4-5 HIV+ YMSM from each site (Chicago and North Carolina) to serve as YAB members over the first year of the study. The investigators will ensure that YAB members are representative of the target population in terms of age, race/ethnicity, sexual orientation/identity, and length of time since diagnosis. At monthly in-person meetings, our two Youth Advisory Boards (YAB) - each consisting of 4 to 5 HIV+ MSM-will evaluate intervention content as it is developed (including imagery and messaging) for acceptability and relevance. Specifically, the investigators will ask YAB members to react to the written tailored content in terms of the content's readability, comprehension, and relevance. The investigators will also elicit the YABs' views on the following areas of intervention design: (a) intervention structure and format \[e.g., organization of the intervention, appropriateness and appeal of language/images, ease of navigating the web-based content\]; (b) intervention content \[e.g., relevance/applicability of intervention content to the population, comprehension of content, interest in the content\]; (c) intervention activities \[e.g., comprehension of activity instructions, acceptability/relevance of activities, desire to engage in activities\]; and (d) overall impressions of the intervention \[e.g., overall utility, overall interest, overall enjoyment\]. Two YABs are being utilized to ensure maximal diversity of viewpoints and developmental stages during intervention development. During the first six months of year one, YAB members will meet with the research team monthly, as this will be a critical time to develop intervention materials. In addition, web-based meetings and email communication will be used to review materials in between in-person sessions. Intervention Development and Usability Testing Prototype ideas will be developed in an iterative fashion with Ayogo to develop low-fidelity clickable prototypes that demonstrate the information architecture and high-level features of the application. Members of the research and app development team will conduct internal usability 'beta testing' to ensure functionality. After any discovered problems are fixed, 4-5 members of the target population recruited as described above from the North Carolina site and 4-5 members of the target population from the Chicago site will participate in usability testing. Usability testing will assess users comprehension of the educational content, understanding and use of intervention features, and overall impressions of app relevance and appeal. Testing will be conducted in accordance with NIH usability guidelines. Each participant will be asked to meet with a research team member and a member of the development team for a guided, interactive tour through the app. Participants will be asked to share their thoughts and impressions aloud as they move through the different components and features of the app. Audiotapes of the testing sessions along with video tapes of the app screen and participants' hands will be analyzed for patterns of use or usability problems, and results will be compiled into a report for the developers and research team, including any recommendations to address problems identified. Ongoing adjustments require an agile, iterative approach throughout usability testing with members of the target population. Specific Aim 2 Conduct a one-month pilot trial of AllyQuest with 20 newly diagnosed HIV+ YMSM. To ensure that the features, platform and content of AllyQuest are acceptable to the target population and that there are no technical challenges or user concerns, the investigators will conduct a one-month pilot trial of use. The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. Individuals will be instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link will be embedded within the app that directly links to study staff if assistance is needed. Strategies used in prior team research studies such as employing research staff with training in cultural sensitivity and experience working with HIV+YMSM, providing appropriate monetary incentives for participation in study evaluations, and using available resources to maintain contact will be employed. The investigators will evaluate participant experience with AllyQuest to understand their technology utilization with a specific focus on usability and mechanisms of action that might underlie the potential effectiveness of the intervention (quality/timing of messages, privacy concerns) and quality of the patient-technology relationship (trust, communication, intrusiveness, health promotion). The investigators will also examine barriers and facilitators for implementation. At the end of the one-month pilot trial, participants will complete a quantitative survey administered via a computer assisted survey instrument (CASI). Qualitative exit interviews will allow for a more in-depth and nuanced understanding of intervention acceptability. Interviews will be semistructured and focus on how participants used AllyQuest over the one-month pilot trial and how they perceive that use of the intervention could translate into behavior change. #Intervention - BEHAVIORAL : AllyQuest - AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The development of this intervention is both timely and vital given the urgency of the ongoing HIV epidemic among YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.

#Eligibility Criteria: Inclusion Criteria: * HIV positive * Diagnosed in the last 12 months * Assigned male at birth and self identify as male * Have had sex with another man in the last twelve months * Own a smart phone * Between the ages of 16 <= age <= 24 Exclusion Criteria: * Assigned female at birth * Non-English speaker * HIV negative Sex : MALE Ages : - Minimum Age : 16 Years - Maximum Age : 24 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT03090958

{ "NCT_ID" : "NCT03428997", "Brief_Title" : "Human Comedogenicity Test", "Official_title" : "Human Comedogenicity Test", "Conditions" : ["Comedogenicity"], "Interventions" : ["Device: Lotion", "Other: Negative Control"], "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)" : "2017-11-20", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-02-05", "Study_Completion_Date(Actual)" : "2018-02-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-01-19", "First_Submitted_that_Met_QC_Criteria" : 2019-07-30", "First_Posted(Estimated)" : 2018-02-12" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-02-08", "Last_Update_Posted(Estimated)" : 2023-07-03", "Last_Verified" : 2023-06" } }}

#Study Description Brief Summary Testing comedogenicity potential of a device cream on humans. #Intervention - DEVICE : Lotion - Formulated Lotion F# 13451-131 was applied on an occlusive patch and placed on a test site on each subjects back three times a week for four weeks. - OTHER : Negative Control - Control. An undosed occlusive patch was placed on a test site on each subjects back three times a week for four weeks.

#Eligibility Criteria: Inclusion Criteria: * Male or female. * 18 <= age <= 45 old. * Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English. * Individuals who are acne-prone with large pores on the back, or individuals who have a history of acne vulgaris on the face or back. * Individuals who have had at least a 2-week rest period since participation in any previous clinical studies involving patch applications on the back. * Individuals who are willing to avoid direct sun exposure on the back and use of tanning beds for the duration of the study. * Generally, in good health based on medical history reported by the subject. * Have generally healthy skin condition appropriate for study assessments * Available for the entire study duration. * Individuals who are willing to keep patch sites as dry as possible and refrain from swimming or soaking in a hot tub for the duration of the study (no showering/bathing restrictions). * Willing to cooperate and follow instructions. * Female subjects, not of child-bearing potential, must meet at least one of the following criteria: Had a hysterectomy and/or bilateral oophorectomy, Be post-menopausal (amenorrhea for at least 1 year), Had a Tubal Ligation, Surgical sterilization (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); * Female subjects, of child-bearing potential, must agree to practice a medically acceptable form of birth control during the study and 30 days after study completion. Females must have used such birth control for at least 3 months prior to study start; * Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include: Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring). Barrier methods of contraception with or without spermicide: condom or occlusive cap (diaphragm or cervical/vault caps), Intrauterine device (IUD) or intrauterine system (IUS), Surgical sterilization (e.g., in a monogamous relationship with male partner with vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy). Abstinence from heterosexual intercourse: When this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; Exclusion Criteria: * Individuals with known allergies or sensitivities to common topical skincare products, including adhesives and/or cyanoacrylate (super glue) or ingredients to the test materials for a specific test panel. * Deprived from liberty by a judiciary or administrative decision. * Having undergone organ excision (kidney, lung, spleen, and liver), an organ transplant, or a skull concussion with extended loss of consciousness within the last 5 years or with present symptoms and/or side effects. * Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia, etc. * Individuals with CONTROLLED health conditions may be excluded from the study at the discretion of the PI or designee: Subjects with conditions that do not affect the skin, such as hypertension and hypercholesterolemia, could be enrolled when their health condition is managed through diet, medication, etc. Subjects with conditions, which might affect the skin, such as hyper/hypothyroidism, diabetes must be excluded, regardless whether their health condition is controlled or not. * Subjects who are taking medication for chronic conditions (e.g., insulin, antihistamines, steroidal and non-steroidal anti-inflammatory drugs, antibiotics, etc...) - exception could be made for hypercholesterolemia. * Individuals with adult asthma and/or epilepsy. * Skin diseases on tested sites (e.g., psoriasis, eczema, erythema, edema, scars, wounds, melanomas, etc.), which may influence the outcome of the study; -----Supplemental Consent During the eligibility screening, individuals who indicate that they have previously had eczema will be advised of the Koebner phenomenon, which refers to the appearance of these conditions either at the patch site or unrelated sites. If the individual chooses to participate in the study, 2 copies of a supplemental consent form will be signed by the subject (1 for the study files and 1 will be given to the subject). * Subjects who are self-reported to be pregnant, lactating or planning to become pregnant; females of child-bearing potential who are unwilling or unable to use an acceptable method of contraception during the study. * Male subjects who have a pregnant partner. * Male subjects whose partner is planning to become pregnant during the study period or is unwilling or unable to use an acceptable method of contraception. * Simultaneous participation in any other type of clinical study. * An individual who has any condition which in the PI's judgment makes the candidate an inappropriate subject for study participation. * Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., PI, sub-investigators, study coordinators, other site personnel, employees of the Sponsor subsidiaries, contractors of the Sponsor, and the families of each). * Individuals with a condition or situation which, in the PI's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study. * Individual viewed by the PI as not being able to complete the study. * Subjects who are planning to use any new personal care products (e.g. makeup) or are planning to change existing brands during the study Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT03428997

{ "NCT_ID" : "NCT02068339", "Brief_Title" : "Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis", "Official_title" : "A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis", "Conditions" : ["Non-alcholic Fatty Liver Disease"], "Interventions" : ["Drug: Oltipraz 2 (120mg)", "Drug: Placebo", "Drug: Oltipraz 1 (90mg)"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-02", "Study_Completion_Date(Actual)" : "2016-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-02-19", "First_Posted(Estimated)" : 2014-02-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-02-20", "Last_Update_Posted(Estimated)" : 2016-03-30", "Last_Verified" : 2016-03" } }}

#Study Description Brief Summary Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c. Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver. #Intervention - DRUG : Oltipraz 1 (90mg) - DRUG : Placebo - DRUG : Oltipraz 2 (120mg)

#Eligibility Criteria: Inclusion Criteria: * Patients over 19 under 75 years * Patients with non-alcoholic fatty liver disease except for cirrhosis * Patients who have abnormal ALT, AST * Patients who are satisfied with laboratory test * Patients who agree to contraception * Patients who can keet the diet Exclusion Criteria: * Over 2 ratio of AST to ALT * Type 1 diabetes mellitus (insulin-dependent diabetes mellitus) or Type 2 diabetes mellitus(not controlled) * Disorder in liver function with an exception of non-alcoholic fatty liver * Patients with malignant tumors * Patients who have been taken drugs induced fatty liver within 8 weeks of participation in this study * Patients who has been taken any medications that could affect the treatment for NAFLD within 4 weeks * Patients who have been taken Vitamin E (>= 800 IU/day), thiazolidinediones, orlistat within 12 weeks * Patients who had a Bariatric surgery less than 6 month prior to the participation in the study * Patients who are judged by investigator that participation of the study is difficult due to disease as follow; * Any history of immune disorder * Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study * Patient who has been administered other investigational product within 1 month prior to the participation in the study * Patient who is not allowed to get MRS test: pacemaker, shunt and etc * Pregnant or nursing women * anti-HIV antibody (+) * Patient who considered ineligible for participation in the study as Investigator's judgment Sex : ALL Ages : - Minimum Age : 19 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02068339

{ "NCT_ID" : "NCT01674855", "Brief_Title" : "Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia", "Official_title" : "Randomized, Open, Multi-Center, Phase III Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy", "Conditions" : ["Chemotherapy Induced Neutropenia"], "Interventions" : ["Drug: G-CSF", "Drug: PEG-G-CSF"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-02", "Study_Completion_Date(Actual)" : "2013-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-01-19", "First_Posted(Estimated)" : 2012-08-29" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-08-27", "Last_Update_Posted(Estimated)" : 2014-10-01", "Last_Verified" : 2014-09" } }}

#Study Description Brief Summary This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily G-CSF in chemotherapy-induced neutropenia. Detailed Description Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle is repeated every 21 days. #Intervention - DRUG : PEG-G-CSF - Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle - Other Names : - DA-3031 - DRUG : G-CSF - Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle - Other Names : - Leucostim®

#Eligibility Criteria: Inclusion Criteria: * Age : >=18, <=70 * Diagnosis of stage II, III or IV breast cancer * ANC>=1,500/mm3, Platelet>=100,000/mm3, ECOG : 0 or 1 * Creatinine < 1.5 x ULN * Total bilirubin/AST/ALT < 1.5 x ULN, ALP < 2.5 x ULN * Have given a written, informed consent Exclusion Criteria: * Prior chemotherapy * Prior bone marrow or stem cell transplantation * Other malignancy history within 5 years * Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors * Received any other investigational drugs within 30 days of informed consent date * Radiation therapy within 4 weeks of informed consent date * Infective symptom before chemotherapy into this study * Received systemic antibiotics within 72 hours of randomization into this study. * HIV positive * Pregnant or lactating women 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

NCT01674855

{ "NCT_ID" : "NCT01669785", "Brief_Title" : "NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study", "Official_title" : "NUPRO Sensodyne Prophylaxis Paste With NovaMin for the Treatment of Dentin Hypersensitivity.", "Conditions" : ["Tooth Hypersensitivity"], "Interventions" : ["Device: Group C", "Device: Group B", "Device: Group A"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-04", "Study_Completion_Date(Actual)" : "2012-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-06-08", "First_Submitted_that_Met_QC_Criteria" : 2014-08-20", "First_Posted(Estimated)" : 2012-08-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-08-17", "Last_Update_Posted(Estimated)" : 2014-08-21", "Last_Verified" : 2014-08" } }}

#Study Description Brief Summary The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days. Detailed Description It is hypothesized that the prophy paste with Novamin will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement. #Intervention - DEVICE : Group C - Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. - Other Names : - NUPRO Classic Prophy Paste - DEVICE : Group A - Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. - Other Names : - NUPRO Sensodyne Prophy Paste with NovaMin with Fluoride. - DEVICE : Group B - Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. - Other Names : - NUPRO Sensodyne Prophy Paste with NovaMin without Fluoride.

#Eligibility Criteria: Inclusion Criteria: * Availability to complete in the 28 day duration. * Two sensitive teeth, which are not adjacent to each other and preferably in different quadrants, which demonstrate cervical erosion, abrasion and gingival recession. * Qualifying response to tactile stimuli as defined by a score of <= 20 grams. * Qualifying response to air blast stimuli as defined by a score of >= 1 on the Schiff Cold Air Sensitivity Scale. * Subjects need to satisfy the qualifying response to stimuli for both parameters assesses (Tactile or Air Blast) on at least two teeth (non-adjacent) to be entered into the study. * Good general health with no known allergies to products being tested. * Use of a non-desensitizing dentifrice for 2 weeks prior to entry into the study. * Subjects must have a minimum of 10 natural teeth, excluding 3rd molars. Exclusion Criteria: * Individuals who exhibit gross oral pathology. * Females who may be pregnant or lactating or intending to become pregnant. * Individuals who require anesthetic during scaling. * Dental pathology which may cause pain similar to tooth sensitivity. * Individuals with large amounts of calculus. * Subjects with active infectious diseases such as hepatitis, HIV, or tuberculosis. * Any condition requiring antibiotic prophylaxis for dental treatment. * Excessive gingival inflammation. * Individuals who had their teeth cleaned within 30 days of the screening appointment. * Individuals who have had desensitizing treatment or tooth bleaching within 90 days of screening appointment. * Oral pathology, chronic disease, or history of allergy to test products. * Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months. * Sensitive teeth with mobility greater than one. * Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures. * Regular use of sedatives, anti-inflammatory drugs, or analgesic. * Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past 4 weeks. * Current participation in any other clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study. * Personnel; a) an employee of the sponsor; b0 A member or relative of teh study site staff directly involved with the study. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01669785

{ "NCT_ID" : "NCT00463567", "Brief_Title" : "26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)", "Official_title" : "A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls", "Conditions" : ["Pulmonary Disease, Chronic Obstructive", "COPD", "Lung Diseases, Obstructive"], "Interventions" : ["Drug: Tiotropium (18 µg o.d.)", "Drug: Formoterol (12 µg b.i.d.)", "Drug: Indacaterol", "Drug: Placebo to Formoterol", "Drug: Placebo to Indacaterol"], "Location_Countries" : ["India", "Sweden", "United States", "Germany", "Taiwan", "Canada", "Spain", "Puerto Rico", "Argentina", "Italy", "Turkey", "Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-08", "Study_Completion_Date(Actual)" : "2008-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-04-19", "First_Submitted_that_Met_QC_Criteria" : 2011-07-22", "First_Posted(Estimated)" : 2007-04-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2007-04-19", "Last_Update_Posted(Estimated)" : 2011-08-18", "Last_Verified" : 2011-07" } }}

#Study Description Brief Summary Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD #Intervention - DRUG : Indacaterol - In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI). - DRUG : Formoterol (12 µg b.i.d.) - Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer. - DRUG : Tiotropium (18 µg o.d.) - Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI. - DRUG : Placebo to Indacaterol - In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI). - DRUG : Placebo to Formoterol - In the morning and in the evening, placebo to formoterol delivered via Aerolizer.

#Eligibility Criteria: Inclusion Criteria: * Male and female adults aged >= 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure * Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and: * Smoking history of at least 20 pack years * Post-bronchodilator FEV1 < 80% and >= 30% of the predicted normal value. * Post-bronchodilator FEV1/FVC < 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol) Exclusion Criteria: * Pregnant or lactating females * Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period * Patients requiring long term oxygen therapy (> 15 h a day) * Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria) * Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis * Patients with a history of asthma (with further criteria) * Patients with Type I or uncontrolled Type II diabetes * Patients with contraindications for tiotropium * Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality * Any patient with active cancer or a history of cancer with less than 5 years disease free survival time * Patients with a history of long QT syndrome or whose QTc interval is prolonged * Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures * Patients who have had treatment with the investigational drug (with further criteria) * Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period * Patients with known history of non compliance to medication * Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements Other protocol-defined inclusion/exclusion criteria may apply Sex : ALL Ages : - Minimum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00463567

{ "NCT_ID" : "NCT02317952", "Brief_Title" : "Formula for Children With Cow's Milk Allergy", "Official_title" : "A Double-Blind, Randomized, Crossover Allergy Study of an Experimental Formula Followed by a 16 Week Double Blind Feeding Period to Assess Growth, Safety and Development of Tolerance to Cow's Milk Protein", "Conditions" : ["Milk Allergy"], "Interventions" : ["Other: Active Comparator Formula", "Other: Experimental Extensively Hydrolyzed Formula"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-07", "Study_Completion_Date(Actual)" : "2016-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-12-02", "First_Posted(Estimated)" : 2014-12-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-12-11", "Last_Update_Posted(Estimated)" : 2017-06-08", "Last_Verified" : 2017-06" } }}

#Study Description Brief Summary The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy. #Intervention - OTHER : Experimental Extensively Hydrolyzed Formula - OTHER : Active Comparator Formula

#Eligibility Criteria: Inclusion Criteria: * Good health * Parent/guardian must be willing to provide informed consent * Parent/guardian agrees to feed study formula provided * Confirmation of Cow's Milk Allergy Exclusion Criteria: * No clinically significant abnormal findings on medical history, laboratory results, and physical exam. * No medications that may interfere with or impact evaluation of the study assessments * Allergy to extensively hydrolyzed casein formula * Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the Screening Visit * Participation in another clinical trial within 30 days of screening where they are are receiving an active intervention Sex : ALL Ages : - Maximum Age : 13 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT02317952

{ "NCT_ID" : "NCT04758871", "Brief_Title" : "Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles", "Official_title" : "Dydrogesterone Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in Hormone Replacement Therapy (HRT) Frozen Embryo Transfer (FET) Cycles.", "Conditions" : ["Frozen Embryo Transfer", "Hormone Replacement Therapy", "Dydrogesterone", "Infertility, Female"], "Interventions" : ["Drug: Micronized progesterone", "Drug: Dydrogesterone 10 MG Oral Tablet"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-10-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-09-11", "Study_Completion_Date(Actual)" : "2024-06-13}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-01-26", "First_Posted(Estimated)" : 2021-02-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-02-15", "Last_Update_Posted(Estimated)" : 2024-06-14", "Last_Verified" : 2024-06" } }}

#Study Description Brief Summary To investigate the efficacy of dydrogesterone 30 mg compared to micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles, as confirmed by visualization of fetal heart activity by pelvic ultrasound assessment of ongoing pregnancy at 12 weeks of gestation. Detailed Description A randomized controlled trial comparing dydrogesterone 30 mg versus micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles. Patients will undergo an embryo transfer in a hormone replacement therapy cycle using Progynova 2 mg three times daily until an endometrium thickness of at least 7 mm is reached. Afterwards two different luteal phase supplementation methods will be compared. The primary outcome of the study is ongoing pregnancy at 12 weeks of gestation. We will also investigate other prenatal and neonatal outcome factors as well as patients satisfaction and safety of dydrogesterone. #Intervention - DRUG : Dydrogesterone 10 MG Oral Tablet - 10 mg three times daily - DRUG : Micronized progesterone - 2x 200 mg vaginal tablets two times daily

#Eligibility Criteria: Inclusion Criteria: * <=40 years at the time of IVF/ICSI treatment * BMI >=18 to <=30 kg/m2 with a documented history of infertility * Have undergone COS as part of an ART treatment and have had an unsuccessful fresh embryo transfer in that cycle, OR, have undergone freeze all strategy * Scheduled to undergo FET with a standard exogenous/programmed hormonal replacement therapy (HRT) regimen * Have at least 1 blastocyst vitrified on the 5th or 6th day after oocyte retrieval * Elective single embryo (blastocyst) transfer (SET) * Normal ultrasound examination at enrollment (or if <12 months old) * Signed patient authorization for use/disclosure of data. Exclusion Criteria: * Women with a history of recurrent miscarriage, defined as >2 consecutive miscarriages (biochemical pregnancy losses are not included) * Absence of implantation (serum hCG = negative) after two consecutive cycles of IVF, ICSI or FET where the cumulative number of transferred embryos was >4 cleavage-stage embryos and >2 blastocysts * Presence of hydrosalpinx that is not surgically treated * Endometrial abnormalities on scanning during ovarian stimulation, such as endometrial polyp(s), sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions * Participating in another clinical study at the same time * Known allergic reactions to dydrogesterone or other progestogens products * Any contraindication or other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions listed in the locally approved label * Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects in or to complete the study * History of prior chemotherapy * Contraindication for pregnancy * Transfer of >1 embryo Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT04758871

{ "NCT_ID" : "NCT01523028", "Brief_Title" : "Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans", "Conditions" : ["Healthy"], "Interventions" : ["Other: Soluble Coffee"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-12", "Study_Completion_Date(Actual)" : "2012-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2012-01-27", "First_Posted(Estimated)" : 2012-02-01" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-01-27", "Last_Update_Posted(Estimated)" : 2013-06-05", "Last_Verified" : 2013-06" } }}

#Study Description Brief Summary Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more important, hence underlying the importance of better understanding the fate of these potential health promoting antioxidants. However, some analytical barriers as well as some key aspects of metabolism still remain to be fully elucidated to get the full picture of coffee metabolism and bioavailability. One aspect addressed in the present study is the impact of food matrix in modulating absorption, plasma appearance and urinary excretion of coffee bioactives. #Intervention - OTHER : Soluble Coffee - Amounts of chlorogenic acids will be normalized to body weight (3.1 mg CA / kg BW). Coffee will be reconstituted in 200 mL hot water and consumed 3 times in a row (min 1-week interval), alone or with a breakfast: * 200 mL coffee or * 200 mL coffee + 2 bread rolls + honey * 200 mL coffee + 1 bread roll + peanut butter

#Eligibility Criteria: Inclusion Criteria: * Healthy men and women * Aged 20 <= age <= 44 years * Caucasian origin * Body mass index (BMI) 19 <= age <= 25 kg/m2 * Used to drinking coffee (similar to study coffee) on a daily basis * Being able to tolerate a 48-hour coffee abstinence * Normal oral glucose tolerance test * Having signed the informed consent form Exclusion Criteria: * Taking medication or dietary supplements * Smoking * Performing a competitive sport * Having metabolic disorders * Long gut transit time (>24 h) * Blood donor * Irregularity in menstrual cycle (for women) * Pregnancy (for women) * Subject who cannot be expected to comply with the study procedures. * Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study. Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 44 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT01523028

{ "NCT_ID" : "NCT01610882", "Brief_Title" : "Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool", "Official_title" : "Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool", "Conditions" : ["Acute Post-operative Pain"], "Interventions" : ["Device: Panda first followed by manual pain assessment", "Device: Manual first followed by Panda pain assessment"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2012-05", "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" : 2012-05-29", "First_Posted(Estimated)" : 2012-06-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-05-31", "Last_Update_Posted(Estimated)" : 2017-10-26", "Last_Verified" : 2017-10" } }}

#Study Description Brief Summary This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps determine what medication they need. Traditionally, this involves asking the child to rate their pain on a scale from 1 to 10, by moving a slider along a coloured scale or pointing to one of a series of faces on a piece of card. The Panda uses the same methods, but presents them on a smartphone screen. Our evaluation will ensure that the Panda gives the same pain scores as the traditional methods. Detailed Description The purpose of this study is to ensure that Panda, a smartphone-based pain assessment tool, can be used effectively by children after surgery and that the pain scores it obtains agree with the scores obtained using traditional methods of pain assessment. In particular the aim is to show agreement (a) between pain scores obtained using Panda and pain scores obtained using the Faces Pain Scale-Revised for 4-12 year olds and (b) between pain scores obtained using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year olds. We will recruit children between 4 and 18 years old, in general good health, who are scheduled for surgery. We will exclude any child who has a psychiatric diagnosis, developmental delay or brain injury, significant visual impairment or psychomotor dysfunction. This study is taking place in the Post-anesthetic Care Unit (PACU) at BC Children's Hospital. We will recruit 200 children in total. The study procedures include the following: Stage 1 - pre-clinical usability study: we will conduct a series of participatory design sessions with nurses in the PACU and with 20 children in the Surgical Day Care Unit (SDCU) Stage 2 - clinical validation study: children will be asked to rate their pain using both the Panda and a traditional tool (which is used first will be decided randomly); during this stage, children will also be asked their opinion (e.g. which tool they preferred using and about any problems they experienced using either tool). All scores will be recorded on the Panda device and extracted at the end of each day. No pain medication will be administered on the basis of a pain score obtained using the Panda. Panda will be compared with the traditional method (FPS-R and CAS) within 3 different age groups (4-8, 8-12 and 12-18), using the following criteria: practicality, based on failure rates in obtaining pain scores from Panda compared with traditional method; preference for Panda compared with traditional method; agreement between the Panda score and the traditional score. #Intervention - DEVICE : Panda first followed by manual pain assessment - Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Panda will be used first, manual method 5 mins later. - DEVICE : Manual first followed by Panda pain assessment - Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Manual method will be used first, Panda 5 mins later.

#Eligibility Criteria: Inclusion Criteria: * Undergoing a surgical procedure for which there is an anticipated post-surgical pain model * Age 4 - 18 years * ASA I-III, not requiring admission to PICU * Written parental/guardian informed consent and subject informed assent when required (subject age >= 7 years) Exclusion Criteria: * Children who have not undergone a surgical procedure (e.g. MRI, X-ray or endoscopy patients) * Inability or refusal to provide informed consent/assent * Developmental delay, neurological injury or psychomotor dysfunction * Children who have a significant visual impairment or have undergone eye surgery Sex : ALL Ages : - Minimum Age : 4 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT01610882

{ "NCT_ID" : "NCT05077293", "Brief_Title" : "Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure", "Official_title" : "BETTER CARE-HF Pilot Study: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure, a Pilot Study", "Conditions" : ["Heart Failure", "Heart Failure With Reduced Ejection Fraction"], "Interventions" : ["Other: In-Basket Message", "Other: Best Practice Alert (BPA)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-09-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-01", "Study_Completion_Date(Actual)" : "2022-01-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-10-03", "First_Posted(Estimated)" : 2021-10-14" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-10-03", "Last_Update_Posted(Estimated)" : 2022-10-28", "Last_Verified" : 2022-02" } }}

#Study Description Brief Summary This is a feasibility study using a cross-over design to implement and compare a best practice alert (BPA) with an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this pilot study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention). Detailed Description An estimated 68,000 deaths per year nationwide can be attributed to gaps in care for patients with heart failure and reduced ejection fraction (HFrEF), with the majority being due to lack of mineralocorticoid receptor antagonists (MRA). Despite proven benefits in randomized trials, class I guideline recommendations, and published clinical performance measures, patients with HFrEF are often not on guideline-directed medical therapy (GDMT). While successful interventions for improvement in prescription of GDMT have often included multidisciplinary approaches with dedicated staff, the relatively high cost of hiring additional personnel has led to an interest in electronic health record (EHR)-based interventions. Prior studies on EHR-based interventions in this arena have mainly been conducted in the inpatient setting, which is limited to one encounter during acute hospitalization, a setting often complicated by renal dysfunction or hypotension that can limit prescription of MRA. The development and study of outpatient EHR-based alerts for HFrEF GDMT are needed. Two types of outpatient EHR-based interventions include best practice alerts (BPA) and automated in-basket messages. Both of these methods have limited data, with some studies showing benefit and others demonstrating provider fatigue and burnout. To our knowledge, there is no study that has directly compared these different types of EHR-based interventions. This is a feasibility study using cross-over design at two outpatient clinics in a large health system to implement and compare a best practice alert (BPA) and an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention). #Intervention - OTHER : Best Practice Alert (BPA) - A BPA will fire in the EHR reminding care providers of the best practice when prescribing medical therapies for heart failure patients. - OTHER : In-Basket Message - An In-Basket message will be sent biweekly to care providers with a reminder of the best practice when prescribing medical therapies for heart failure

#Eligibility Criteria: Inclusion Criteria: * Cardiologist visit * Transthoracic echocardiogram with the most recent EF >= 40% Exclusion Criteria: * Hypotension: SBP < 95 * Hyperkalemia: most recent K > 5.1, or any K >5.5 * Renal dysfunction: eGFR < 30 * Ventricular assist device * Hospice care Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT05077293

{ "NCT_ID" : "NCT03685747", "Brief_Title" : "Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis", "Official_title" : "A Prospective, Single-site, Open-label, Pharmacokinetic Study of Intermittent Intraperitoneal Vancomycin in Adult Subjects Receiving Automated Peritoneal Dialysis", "Conditions" : ["Peritoneal Dialysis-associated Peritonitis"], "Interventions" : ["Drug: Vancomycin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-11-15", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-08-30", "Study_Completion_Date(Actual)" : "2020-10-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-09-25", "First_Submitted_that_Met_QC_Criteria" : 2022-03-01", "First_Posted(Estimated)" : 2018-09-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-09-25", "Last_Update_Posted(Estimated)" : 2022-03-03", "Last_Verified" : 2022-03" } }}

#Study Description Brief Summary Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric, especially for those on rapid-cycling modalities. The goal of this study is to understand the pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in order to derive an optimal dosing regimen. Detailed Description Peritoneal dialysis (PD) is a form of renal replacement therapy indicated for those with acute kidney injury or end stage renal disease. Currently, two modalities of PD exist and is individualized based on patient and life-style specific factors. Continuous ambulatory peritoneal dialysis (CAPD) allows 4 - 5 exchanges performed manually whereas automated peritoneal dialysis (APD) involves continuous, automated, cyclical exchanges performed by a device at home during the night. Peritonitis is a common complication in PD and accounts for a large portion of hospital readmission and mortality. Vancomycin is the most common antibiotic recommended and has notable gram-positive coverage used empirically during suspected peritonitis. Despite widespread use, vancomycin lacks good pharmacokinetic characterization in PD. Early pharmacokinetic studies using vancomycin were conducted predominantly in patients on CAPD on glucose-based prescriptions. Data is non-existent in PD patients administered the novel dialysate solution icodextrin, or those treated with overnight APD. The impact of residual kidney function (RKF) on vancomycin in PD is also lacking. Enhanced vancomycin clearance in RKF may result in under-dosing, while overdosing may result in nephrotoxicity and loss of clinically important RKF. The investigators will characterize the pharmacokinetic profile of vancomycin following a single intraperitoneal dose of vancomycin in icodextrin dialysate to non-infected PD patients and examine the relationship between RKF and vancomycin clearance using serum, dialysate and urine. The goal is to use this data in non-infected subjects to generate information to guide vancomycin dosing in patients on rapid-cycling PD modalities. #Intervention - DRUG : Vancomycin - Vancomycin one-time 20 mg/kg intraperitoneal dose.

#Eligibility Criteria: Inclusion Criteria: * Adult male or females between 18 - 85 years * Stabilized on a PD regimen for > 3 months prior to study initiation Exclusion Criteria: * Clinically significant disease unrelated to renal impairment or deemed unfit by the investigator * Allergy or hypersensitivity to vancomycin or icodextrin-containing dialysis solution * Active peritonitis infection * Previous intraperitoneal antibiotic treatment within 2 months * Previous intravenous vancomycin treatment within 2 months * Hemoglobin < 9 g/dL * Pregnant or breast-feeding women Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03685747

{ "NCT_ID" : "NCT00643760", "Brief_Title" : "A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)", "Official_title" : "Study PXN110448: A Dose-response Study of XP13512, Compared With Concurrent Placebo Control and LYRICA(Pregabalin), in Subjects With Neuropathic Pain Associated Withdiabetic Peripheral Neuropathy (DPN)", "Conditions" : ["Neuropathy, Diabetic"], "Interventions" : ["Drug: GEn 2400mg/day", "Drug: GEn 1200mg/day", "Drug: Pregabalin", "Drug: GEn 3600mg/day", "Drug: Placebo"], "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)" : "2008-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-02", "Study_Completion_Date(Actual)" : "2009-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-02-19", "First_Submitted_that_Met_QC_Criteria" : 2011-04-21", "First_Posted(Estimated)" : 2008-03-26" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-03-19", "Last_Update_Posted(Estimated)" : 2013-07-22", "Last_Verified" : 2013-01" } }}

#Study Description Brief Summary The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN) Detailed Description This is a dose-response study of XP13512 compared with concurrent placebo control and LYRICA (pregabalin), in subjects with neuropathic pain associated with DPN. Three doses of XP13512 (1200 mg/day, 2400 mg/day and 3600 mg/day) are being evaluated for the management of neuropathic pain associated with DPN. Approximately 392 subjects from 70 to 80 participating sites in the US will be randomized to receive either XP13512 at the above mentioned doses, placebo or pregabalin (300mg/day). #Intervention - DRUG : Placebo - placebo - DRUG : GEn 1200mg/day - gabapentin enacarbil 1200mg/day - Other Names : - XP13512, GSK1838262, gabapentin enacarbil - DRUG : GEn 2400mg/day - gabapentin enacarbil 2400mg/day - Other Names : - gabapentin enacarbil, GSK1838262, XP13512 - DRUG : GEn 3600mg/day - gabapentin enacarbil 3600mg/day - Other Names : - XP13512, GSK1838262, gabapentin enacarbil - DRUG : Pregabalin - pregabalin 300mg/day

#Eligibility Criteria: Inclusion criteria: * >= 18 years * Female subjects are eligible to enter if of non-childbearing potential or not lactating, has a negative pregnancy test and agrees to use a specified highly effective method for avoiding pregnancy * Documented medical diagnosis of Type 1 or 2 diabetes including: * Stable glycemic control for 3 months defined as <25% change of routine insulin, <50% change of routine oral anti-diabetic agent dose and HbA1c < 8%. (HbA1c of 8 to 11% eligible if attempts to improve diabetic control failed) * DPN defined by: * Bilateral reduced or absent reflexes at the ankles, or * Bilateral impaired vibration, pinprick, fine touch or temperature perception in the distal lower extremities And * Persistent distal burning or dull pain in the feet, or * Persistent proximal aching pain in the legs, or * Paroxysmal electric, shooting, stabbing pain, or * Dysasthesias, or * Evoked pain And * history of pain for at least six months and no greater than five years attributed to DPN (refers to duration of pain) * Baseline 24-hour average daily pain intensity score >4.0 as measured on an 11 point pain intensity numerical rating scale * Provides written informed consent in accordance with all applicable regulatory requirements Exclusion criteria: * Other chronic pain conditions not associated with DPN. However, the subject will not be excluded if: * The pain condition is located at a different region of the body, and * The pain intensity of this condition is not greater than the pain intensity of the DPN, and * The subject can assess their DPN independently of other pain condition. * Other causes of neuropathy or lower extremity pain * Is unable to discontinue prohibited medications or non-drug therapies or procedures throughout the duration of the study * Hepatic impairment defined as ALT or AST > 2x upper limit of normal (ULN) or alkaline phosphatase or bilirubin > 1.5x ULN * Chronic hepatitis B or C * Impaired renal function defined as either creatinine clearance < 60 mL/min or requiring hemodialysis * Corrected QT (QTc) interval >450 msec or QTc interval >480 msec for patients with Bundle Branch Block * Uncontrolled hypertension at screen (sitting systolic >160 mmHg and/or sitting diastolic >90 mmHg * Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drug(s) * Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GEn or pregabalin, or, in the investigator's judgment: * Is considered to be clinically significant and could pose a safety concern or, * Could interfere with the accurate assessment of safety or efficacy, or, * Could potentially affect a subject's safety or study outcome * Meets criteria defined by the DSM-IV-TR for a major depressive episode or for active significant psychiatric disorders within last year * Depression in remission, with or without antidepressant treatment, may participate, unless stable antidepressant regimen is a prohibited medication * Antidepressant medication may not be changed or discontinued to met entry criteria and must be stable for at least 3 months prior to enrollment * History of clinically significant drug or alcohol abuse (DSM-IV-TR). Benzodiazepines or atypical benzodiazepines as hypnotic sleep agents permitted * Currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device * Has participated in a clinical study and was exposed to investigational or non-investigational drug or device: * Within preceding month for studies unrelated to DPN, or * Within six months for studies related to DPN * Treated previously with GEn * History of allergic or medically significant adverse reaction to investigational products (including gabapentin or pregabalin) or their excipients, acetaminophen or related compounds 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

NCT00643760

{ "NCT_ID" : "NCT04119323", "Brief_Title" : "Image Location and Performance of Left Bundle Branch Pacing", "Official_title" : "Image Location and Performance of Left Bundle Branch Pacing", "Conditions" : ["Cardiac Pacing", "Pacing Therapy"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-09-24", "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" : 2019-09-30", "First_Posted(Estimated)" : 2019-10-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-10-07", "Last_Update_Posted(Estimated)" : 2020-12-11", "Last_Verified" : 2020-12" } }}

#Study Description Brief Summary This is a prospective, multi-site, non-randomized, data collection study. The purpose of this study is to investigate the correlation between pacing sites and ECG morphology or pacing parameters during left bundle branch pacing (LBBP) and perform the use condition analysis to assess the long-term performance of pacing lead during LBBP. Detailed Description His bundle pacing (HBP) is a physiological pacing, but also has some limitations, including high and unstable pacing threshold in 5-10% patients, low R-wave amplitude causing inappropriate pacing management, damage to the His bundle during implantation. On the other hand, left bundle branch pacing (LBBP), achieved via trans-ventricular septal approach with the pacing lead tip at the left side of the ventricular septum, has recently initiated and been widely practiced in China because of easy implantation, relatively narrow paced QRS duration, low and stable pacing threshold, high R wave amplitude, and the LBBB correction by a low pacing output. As LBBP is in the early phase of clinical practice in China, in order to better conduct LBBP implantation and understand mechanisms of LBBP therapy, physicians often do imaging assessment of the pacing lead in patients implanted with LBBP based on clinical necessity. Additionally, there is no report of mid/long-term correlation between lead location and ventricular electrical activity, nor mid/long-term pacing lead performance assessment during LBBP.

#Eligibility Criteria: Inclusion Criteria: * Aged from 18 <= age <= 80 old; * Patients providing signed Informed Consent; * Patients indicated for permanent pacing and implanted with LBBP for at least 3 months, with documentation of implantation records; * Patients who plan to receive cardiac CT examination. Exclusion Criteria: * Patients who have a history of allergy to contrast agent or refuse to use contrast agent in CT examination; * Patients who are pregnant or have a plan for pregnancy during the study; * Patients who are not willing to provide Informed Consent; * Patients who have medical conditions that would limit study participation; * Patients who were already enrolled in other clinical trial which would impact his/her participation. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT04119323

{ "NCT_ID" : "NCT00983840", "Brief_Title" : "Family Eats:Cancer Prevention for Families", "Official_title" : "Family Eats:Cancer Prevention for Families", "Conditions" : ["Healthy"], "Interventions" : ["Other: Family Eats"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-10", "Study_Completion_Date(Actual)" : "2012-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-07-30", "First_Posted(Estimated)" : 2009-09-24" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-09-22", "Last_Update_Posted(Estimated)" : 2015-03-20", "Last_Verified" : 2012-02" } }}

#Study Description Brief Summary Poor diets lead to weight problems, and may increase cancer risk. Cancers may develop over a long period of time, with some possibly initiating in childhood. Therefore, promoting healthy diets and preventing excess weight gain during childhood could be cancer protective. Families influence children's dietary behaviors by their actions and controlling the home food environment. The internet provides family access to interventions with the convenience of the home. An eight-session interactive web-based program promoting a healthy home food environment for African-American families with 9-12 year old daughters (Family Eats) was previously developed and tested. This study tests whether the Family Eats web program improves diet and weight outcomes among 320 African-American families with 8-12 year old children. This important study will pioneer a new channel for behavior change intervention with African-American families and holds the promise of reaching large numbers of children and their families, enabling all to adopt healthy eating behaviors and achieve energy balance and reduce cancer risks. Detailed Description Although the burden of cancer is high among individuals of all ethnicities, ethnic differences in cancer incidence and mortality exist. African-Americans experience a higher incidence of certain cancers compared with the White population, with mortality rates at least 40% higher than other populations. Obesity, high fat, and low fruit (F) and vegetable (V) intakes increase cancer risks. Cancers may develop over a long period of time, with some possibly initiating in childhood; therefore, promoting FV and preventing excess weight gain during childhood could be cancer protective. Families influence children's dietary behaviors by direct modeling of dietary behaviors, parenting skills around food, and controlling the home food environment. However, few intervention studies have focused on family influences on dietary behaviors, particularly among ethnic minority groups which may differ in cultural and other aspects of family functioning. Unfortunately, low participation rates for community-based family interventions suggest that alternate intervention delivery systems be investigated. The internet provides family access within the convenience of the home. In a previous R21 application, the Principal Investigator developed an eight-session interactive web-based program promoting a healthy home food environment for African-American families with 9-12 year old daughters (Family Eats). Family Eats was evaluated for feasibility and changes in mediating variables were obtained. This proposal will test the efficacy of the Family Eats web program to improve FV and dietary fat behavior and weight outcomes among 320 AA families with 8-12 year old children. This important study will pioneer a new channel for behavior change intervention with African-American families and holds the promise of reaching large numbers of children and their families, enabling all to adopt healthy eating behaviors and achieve energy balance and reduce cancer risks. #Intervention - OTHER : Family Eats - 8-session web-based program on healthy eating for African American families

#Eligibility Criteria: Inclusion Criteria: * African -American families with 8 <= age <= 10 year old children * Home computer with dsl line Exclusion Criteria: * Parents or children who report a medically prescribed diet, identified through a pre-screening questionnaire, will be excluded because these mothers may have received prior dietary counseling and have increased motivation for making dietary changes. Sex : ALL Ages : - Minimum Age : 8 Years - Maximum Age : 10 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes

NCT00983840

{ "NCT_ID" : "NCT01104493", "Brief_Title" : "A Clinical Study to Assess the Safety of a New Influenza Vaccine", "Official_title" : "A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety of a New 6:2 Influenza Virus Reassortant", "Conditions" : ["Healthy"], "Interventions" : ["Other: Placebo", "Biological: Monovalent Frozen FluMist®"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "QUADRUPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-06", "Study_Completion_Date(Actual)" : "2010-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-04-13", "First_Submitted_that_Met_QC_Criteria" : 2011-06-14", "First_Posted(Estimated)" : 2010-04-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-04-13", "Last_Update_Posted(Estimated)" : 2011-07-18", "Last_Verified" : 2011-07" } }}

#Study Description Brief Summary To assess the safety of a new influenza virus vaccine containing a new virus strain in healthy patients prior to the release of the vaccine. Detailed Description This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18-49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. This study will be conducted at multiple sites in the United States. Randomization will be stratified by site. Each subject will receive one dose of investigational product on Study Day 1. The duration of study participation for each subject is the time from receipt of investigational product through 180 days after receipt of investigational product. To summarize the primary safety phase data (Study Days 1-8), the study will be unblinded to the analysis team at MedImmune after all data through at least Study Day 8 are locked. #Intervention - BIOLOGICAL : Monovalent Frozen FluMist® - Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1. - OTHER : Placebo - Single dose of placebo (60 subjects) by intranasal spray on Study Day 1

#Eligibility Criteria: Inclusion Criteria: * Male or female, 18 through 49 years (not yet reached their 50th birthday) at the time of investigational product administration * Healthy by medical history and physical examination * Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States of America, European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations * Female subjects of child-bearing potential, (ie, unless at least 2 years postmenopausal, surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, or practices abstinence) must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to administration of investigational product, and must agree to continue using such precautions for 60 days after investigational product administration. In addition, the subject must also have a negative urine or blood pregnancy test at screening and, if screening and Day 1 do not occur on the same day, on the day of vaccination prior to randomization. * Males, unless surgically sterile must use an effective method of birth control with a female partner and must agree to continue using such contraceptive precautions for at least 30 days after dosing with investigational product (from Study Day 1 through Study Day 31) * Subject available by telephone * Ability to understand and comply with the requirements of the protocol, as judged by the investigator * Ability to complete follow-up period of 180 days after dosing as required by the protocol Exclusion Criteria: * History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations * History of hypersensitivity to gentamicin * Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year Note: A history of asthma that requires regular medical follow-up or hospitalization during the preceding 2 years is exclusionary. Investigator judgment is required to determine whether or not a subject has a history of asthma; however, for adult subjects, a remote history of wheezing or a remote diagnosis of asthma that the investigator does not consider to be relevant to current health does not need to be considered to be a history of asthma. For example, childhood asthma that has not required treatment in adulthood is not necessarily exclusionary * Acute febrile (> 100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization * Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus (HIV) infection, or ongoing immunosuppressive therapy * History of Guillain-Barré syndrome * A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); additionally, subject should avoid close contact with severely immunocompromised individuals for at least 21 days after receipt of investigational product * Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product * Receipt of any non-study vaccine within 30 days prior to randomization, or expected receipt through 30 days after receipt of investigational product * Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of investigational product Note: A daily dose of up to 81 mg of aspirin for prophylactic use is not considered a contraindication to enrollment. * Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of investigational product * Receipt of influenza antiviral therapy or antiviral agents within 48 hours prior to investigational product administration or expected receipt of influenza antiviral therapy or antiviral agents through 14 days after receipt of each dose of investigational product * Known or suspected mitochondrial encephalomyopathy * Nursing mother * Any condition (eg, chronic cough) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results * Employees of the clinical study site, any other individuals involved with the conduct of the study, or immediate family members of such individuals Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 49 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT01104493

{ "NCT_ID" : "NCT03974087", "Brief_Title" : "The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment", "Official_title" : "The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment - a Combined MRI and Non-invasive Brain Stimulation Study", "Conditions" : ["Mild Cognitive Impairment"], "Interventions" : ["Device: Transcranial Direct Current Stimulation (tDCS)"], "Location_Countries" : ["Czechia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-02-19", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-10-30", "Study_Completion_Date(Actual)" : "2022-12-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-05-10", "First_Posted(Estimated)" : 2019-06-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-06-03", "Last_Update_Posted(Estimated)" : 2023-03-15", "Last_Verified" : 2021-09" } }}

#Study Description Brief Summary Progressively causes the breakdown of cognitive functions and impairs quality of life for patients and their caregivers. In addition to memory impairment, visual attention is also compromised, even at the stage of mild cognitive impairment due to AD (MCI-AD). No treatment has been found for MCI-AD; therefore, attention has been drawn to non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), in order to enhance cognitive functions by modifying brain plasticity. In the current research, investigator aim to examine the long-term effects of the optimal multiple-session tDCS protocol in MCI-AD on visual attention including the transfer to an ecologically valid virtual environment and identify the neural underpinnings of tDCS-induced behavioral aftereffects using a combined tDCS/ MRI network-based approach. Detailed Description Investigator will investigate the long-term effects of 10 active tDCS consecutive sessions using an optimized stimulation protocol as compared to a placebo stimulation on visual attention in the MCI-AD. A two-parallel-group, randomized, placebo-controlled design will be used. In addition, the cognitive transfer of tDCS will be evaluated. Repeated tDCS sessions will be performed in 10 consecutive sessions (2 weeks: Monday to Friday) over one preselected ROI together with ongoing visual attention training. During the stimulation, investigator will use the visual matching task. Before the repeated stimulation sessions, participants will undergo the neurocognitive examination. Behavioral examinations of the trained and untrained tasks (i.e. the transfer tasks) will be performed to assess the baseline performance. MRI protocol consisting of T1, T2, FLAIR, and fMRI during the task performance (visual matching task), resting state fMRI, and DTI sequences will be acquired before and after the whole 10-day stimulation protocol in order to search for active vs. placebo tDCS-induced changes in brain activation and resting state functional and structural connectivity and to identify neural correlates of behavioral changes. Behavioral assessment of the trained task and the transfer task will be repeated immediately after and again at a one-month follow-up visit after the end of the last stimulation session #Intervention - DEVICE : Transcranial Direct Current Stimulation (tDCS) - 2mA stimulation for 20 minutes

#Eligibility Criteria: Inclusion Criteria: * amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (Albert et al., 2011) Exclusion Criteria: * psychiatric disorders, including major depression, major vascular lesions, and other brain pathologies detected by MRI that might present with cognitive decline * a cardio pacemaker or any MRI-incompatible metal in the body * epilepsy * any diagnosed psychiatric disorder * alcohol/drug abuse * lack of cooperation * presence of dementia. Sex : ALL Ages : - Minimum Age : 60 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03974087

{ "NCT_ID" : "NCT01533090", "Brief_Title" : "Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy", "Official_title" : "Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy", "Conditions" : ["Colonic Polyps", "Cancer Colon", "Inflammatory Bowel Disease"], "Interventions" : ["Drug: polyethylene glycol (PEG)", "Drug: PEG low volume with bisacodyl"], "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)" : "2010-04", "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" : 2012-02-07", "First_Posted(Estimated)" : 2012-02-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2012-02-11", "Last_Update_Posted(Estimated)" : 2012-02-15", "Last_Verified" : 2010-03" } }}

#Study Description Brief Summary The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy. Detailed Description A polyethylene glycol (PEG) electrolyte lavage solution (PEG-ELS) was originally developed in 1980 by the Fordtran group as isosmotic preparation for minimal water and electrolyte exchange with plasma to ensure safe cleansing of the bowel through a mechanical effect of large-volume lavage. The conventional total dose of 4 L given the day before the procedure is safe and effective and has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG-ELS have been shown to provide adequate colon cleansing and better tolerability. In the last recent years, time of preparation has been demonstrated to be a critical factor for bowel preparation for colonoscopy. Several studies have demonstrated that reducing the time interval between the completion of bowel preparation and the exam improves colon cleansing compared with standard dose regimen of the PEG-electrolyte solution given the day before colonoscopy. At the same time manufacturers have tried to improve the taste and palatability of PEG formulations by adding suitable ingredients such as ascorbic acid or citric acid. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy. The results of this study will tells us if the last-hour preparation is effective and offers adequate tolerability and compliance to be adopted in clinical practice. #Intervention - DRUG : polyethylene glycol (PEG) - SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY - DRUG : PEG low volume with bisacodyl - Lovolesse + Lovoldyl 2L of Lovolesse with 2 or 3 tablets of bisacodyl the day before of colonoscopy or 2L of Lovolesse with 2 or 3 tablets of bisacodyl the same day of colonoscopy

#Eligibility Criteria: Inclusion Criteria: * both sexes * aged between 18 and 85 yr * undergoing a complete colonoscopy Exclusion Criteria: * known or suspected gastrointestinal obstruction or perforation * toxic megacolon * major colonic resection * pregnant or at risk of becoming pregnant women * lactating women * inability to comprehend the full nature and purpose of the study * no signed informed consent prior to inclusion in the study * known or suspected hypersensitivity to the active principles or other ingredients * history of anaphylaxis to drugs or allergic reactions in general 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

NCT01533090

{ "NCT_ID" : "NCT00455026", "Brief_Title" : "Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia", "Official_title" : "Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia", "Conditions" : ["Depth of Anaesthesia"], "Interventions" : ["Drug: remifentanil"], "Location_Countries" : ["Australia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2006-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-10", "Study_Completion_Date(Actual)" : "2007-10}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-04-01", "First_Posted(Estimated)" : 2007-04-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2007-04-02", "Last_Update_Posted(Estimated)" : 2013-05-30", "Last_Verified" : 2007-03" } }}

#Study Description Brief Summary Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery. Detailed Description Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured. The raw EEG will be recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will then proceed according to the needs of the patient and the surgery. #Intervention - DRUG : remifentanil - target effect site concentration during induction - Other Names : - No other names

#Eligibility Criteria: Inclusion Criteria: * Male and female patients, aged 18 <= age <= 60 years, of ASA physical status 1 <= age <= 3, presenting for elective surgery under general anaesthesia Exclusion Criteria: * Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability * Epilepsy or other EEG abnormality * Prescription or illicit drugs known to affect the EEG 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

NCT00455026

{ "NCT_ID" : "NCT04542070", "Brief_Title" : "A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed", "Official_title" : "A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed", "Conditions" : ["HIV Infections"], "Interventions" : ["Drug: Rilpivirine Injectable Suspension (RPV LA)", "Drug: Cabotegravir Injectable Suspension (CAB LA)", "Drug: BIKTARVY Tablets (BIK)", "Drug: Rilpivirine Tablets", "Drug: Cabotegravir Tablets"], "Location_Countries" : ["France", "Japan", "Netherlands", "United States", "Germany", "Canada", "Austria", "Spain", "Australia", "Ireland", "Switzerland", "Italy", "Belgium", "United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-11-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-07-13", "Study_Completion_Date(Actual)" : "2023-04-17}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-09-01", "First_Submitted_that_Met_QC_Criteria" : 2023-08-23", "First_Posted(Estimated)" : 2020-09-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-09-01", "Last_Update_Posted(Estimated)" : 2024-06-04", "Last_Verified" : 2024-06" } }}

#Study Description Brief Summary This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences. #Intervention - DRUG : Cabotegravir Tablets - CAB tablets were available as film coated tablets for oral administration. - DRUG : Cabotegravir Injectable Suspension (CAB LA) - CAB LA was available as sterile suspension for injection in GSK1265744 for administration as IM injection. - DRUG : Rilpivirine Tablets - RPV was administered as tablets for oral administration. - DRUG : Rilpivirine Injectable Suspension (RPV LA) - RPV LA was available as a sterile suspension of RPV to be administered as an IM injection. - DRUG : BIKTARVY Tablets (BIK) - BIK was a three-drug fixed dose combination product BIC, FTC, and TAF for oral administration.

#Eligibility Criteria: Inclusion Criteria: * Participants aged >= 18 years (or >=19 where required by local regulatory agencies), at the time of signing the informed consent. * A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization), not lactating, and at least one of the following conditions applies. 1. Non-reproductive potential defined as: * Pre-menopausal females with one of the following: 1. Documented tubal ligation. 2. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion. 3. Hysterectomy. 4. 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 enrollment. 2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures. * Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category. * Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. BIK must be the participant's first or second regimen. If BIK is the second regimen, the first regimen must be an integrase inhibitor (INI) regimen. Only a single prior Integrase inhibitor (INI) regimen is allowed if BIK is a second line regimen >=6 months prior to screening. Any history of non-integrase strand transfer inhibitor regimens (that is. non-nucleoside reverse transcriptase inhibitor, protease inhibitor, C-C chemokine receptor 5 and other entry inhibitors) are not permitted. Any prior change in regimen, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for treatment failure (HIV-1 RNA >=400 c/mL). The following are limited exceptions: * A change from Tenofovir disoproxil fumarate (TDF) to TAF will not be considered a regimen change. * Historical perinatal use of Nucleoside reverse transcriptase inhibitor (NRTI) when given in addition to an ongoing Highly active antiretroviral therapy (HAART) will not be considered a change in ART therapy regimen. * The past use of ARVs in the context of Post Exposure Prophylaxis (PEP) or Pre-Exposure Prophylaxis (PrEP) while the participant was HIV negative will be allowed. Such cases will be evaluated on a case by case basis with the Medical Monitor, and may require documentation of HIV negative serology during time of PEP or PrEP. * A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy. * A change in formulation from multiple class regimens to single treatment regimens (of the same medications) would not be considered a change in ART regimen. * Documented evidence of plasma HIV-1 RNA measurements <50 c/mL in the 6 months prior to Screening. * Plasma HIV-1 RNA <50 c/mL at Screening. Exclusion Criteria: * Within 6 months prior to Screening, any plasma HIV-1 RNA measurement >=50 c/mL. * Within the 6 to 12-month window prior to Screening, documented evidence of any plasma HIV-1 RNA measurement greater than (>)200 c/mL, or 2 or more plasma HIV-1 RNA measurements >=50 c/mL. * History of prior treatment failure to any Department of Health and Human Services (DHHS) recommended ART regimen. * History of drug holiday >1 month for any reason prior to Screening visit, except where all ART was stopped due to tolerability and/or safety concerns. * Any change to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement >=200 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen). * Participants who are currently participating in or anticipate being selected for any other interventional study. * Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study. * Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts <200 cells/microliter are not exclusionary. * Participants with moderate to severe hepatic impairment. * Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment. * All participants will be screened for syphilis. * Participants with untreated secondary (late latent) or tertiary syphilis infection, defined as a positive rapid plasma reagin (RPR) and a positive treponemal test without clear documentation of treatment, are excluded. * Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor. * Participants with primary syphilis or early latent secondary syphilis (acquired within the preceding year) who have a positive RPR test and have not been treated may be treated during the screening period and if completion of antibiotic treatment occurs during the screening period, may be allowed entry after consultation with the Medical Monitor. If antibiotic treatment cannot be completed before the screening window ends, participants may be rescreened once following completion of antibiotic therapy for primary or early latent secondary syphilis. * Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. * The participant has a tattoo, gluteal implant/enhancements or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. * Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: 1. Participants positive for HBsAg are excluded. 2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded. * Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who require or qualify for immediate HCV treatment are excluded for those co-infected participants who post entry into Switch Onto Long Acting Regimen (SOLAR) decide treatment for HCV infection is warranted or desired either by the participant or by the treating physician. Participants with HCV co-infection will be allowed entry into this study if: * Liver enzymes meet entry criteria * HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the Month 14 visit. Additional information (where available) on participants with HCV co-infection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. * In the event that recent biopsy or imaging data is not available or inconclusive, the fibrosis (Fib)-4 score will be used to verify eligibility i. Fib-4 score >3.25 is exclusionary ii. Fib-4 scores 1.45 <= age <= 3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: d. Age x aspartate aminotransferase (AST)/ Platelets x (square [Alanine aminotransferase {ALT}]). * Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis, or decompensated cirrhosis [for example {e.g.} ascites, encephalopathy, or variceal bleeding]), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). * History of liver cirrhosis with or without hepatitis viral co-infection. * Ongoing or clinically relevant pancreatitis * Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization. * Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication. * History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled. * Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [<=]325 milligram) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease. * Corrected QT interval (QTc [Bazett]) >450 milliseconds (msec) or QTc (Bazett) >480 msec for participants with bundle branch block. * Known or suspected active Coronavirus Disease-2019 (COVID-19) infection or has had contact with an individual with known COVID-19, within 14 days of study enrollment. * Known or suspected presence of resistance mutations as defined by the International Antiviral Society-United States of America (IAS-USA) resistance guidelines to the individual components of BIK (BIC, FTC, TAF), RPV, and CAB by any historical resistance test result. * Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result. * Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound. * Participant has estimated creatine clearance <30mL/minute per 1.73 meter square (m^2) via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method. * ALT >=3 times upper limit of normal (ULN). * Exposure to an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study. * Treatment with any of the following agents within 28 days of Screening: * radiation therapy; * cytotoxic chemotherapeutic agents; * tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid/INH); * anti-coagulation agents; * Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. * Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of study Day 1. Treatment with acyclovir/valacyclovir is permitted. * Use of medications which are associated with Torsade de Pointes. * Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. 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

NCT04542070

{ "NCT_ID" : "NCT03576846", "Brief_Title" : "Spinal Pain and Autonomic Responses to Chiropractic Care", "Official_title" : "The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation", "Conditions" : ["Neck Pain"], "Interventions" : ["Other: Stretching", "Other: Stretching and Spinal manipulative therapy"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "TRIPLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-01-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-05-02", "Study_Completion_Date(Actual)" : "2020-05-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-06-20", "First_Posted(Estimated)" : 2018-07-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-06-23", "Last_Update_Posted(Estimated)" : 2020-09-10", "Last_Verified" : 2020-09" } }}

#Study Description Brief Summary This randomized, single-blinded study will investigate the effects of Spinal Manipulative Therapy on Heart Rate Variability and Pain Sensitivity in a population of patients with recurrent and persistent neck pain. Alongside, the study will also develop a clinical test for Conditioned Pain Modulation and investigate its predictive properties. Detailed Description Previously, Spinal Manipulative Therapy (SMT) was thought to mechanically affect the restoration of muscular and joint function, by normalising muscle tension and joint mobility. However, recent research has suggested that SMT may be influencing the incoming/ascending pain signals and/or the excitability of the central pain regulating mechanisms. People with chronic neck/shoulder pain have been found to have a disturbance of the Autonomic Nervous System (ANS). Little is known about the changes in the ANS and its relation to changes in pain in a series of treatments conducted in a clinical setting. This multicentre randomized controlled clinical trial will be carried out in multimodal primary care clinics where both physiotherapists and chiropractors are consulted for musculoskeletal issues are selected to minimize selection bias from the patient's pre-desired treatment modality. The subjects will be recruited among patients seeking care for persistent or recurrent Neck pain (NP), either self-selected or through referrals from general practitioners in the local areal. The aim is to study the effect of SMT and stretching exercises compared to stretching exercises alone, two well-known interventions for NP, during a two-week treatment regimen. The primary outcome is the activity of the autonomic nervous system (Heart Rate Variability (HRV), but also Conditioned Pain Modulation (CPM) will be measured. HRV and CPM will be measured at baseline, prior to the third treatment and after the fourth treatment. The subjective pain experience will be investigated by using two different instruments accessing pain intensity and the affective quality of pain, asked at the assessments during the two weeks of treatment and 2 months after the period of intervention ends. Highly structured data collection procedures should provide reliable data to answer these questions. The study utilizes normal clinical procedures, which should aid the transferability of the results. #Intervention - OTHER : Stretching and Spinal manipulative therapy - Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy - OTHER : Stretching - Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.

#Eligibility Criteria: Inclusion Criteria: * minimum 18 years, * able to read and understand Swedish, * persistent or recurrent Neck Pain (duration of current episode more than 6 months and at least one previous episode of NP), * no chiropractic treatment during the previous 3 months. Exclusion Criteria: * conditions or medications that will affect the Heart Rate Variability measurements (cardiovascular disease, diabetes, pregnancy, obesity, currently using pain-reducing medication, steroids or antidepressants), * all contraindications to manual treatment, (anything that could seriously aggravate the pain (such as inflammatory conditions) or signal cerebrovascular injuries (previous drop attacks or a recent episode of new headache or dizziness). 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

NCT03576846

{ "NCT_ID" : "NCT03117231", "Brief_Title" : "Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis", "Official_title" : "Effects of Transcranial Direct Current Stimulation (tDCS) on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory System: Protocol for a Randomized Clinical Trial", "Conditions" : ["Osteoarthritis, Knee", "Chronic Pain"], "Interventions" : ["Device: Active Transcranial Direct Current Stimulation (tDCS)", "Device: Sham Transcranial Direct Current Stimulation (tDCS)"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2018-03-15", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-06-01", "Study_Completion_Date(Actual)" : "2019-07-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-04-06", "First_Posted(Estimated)" : 2017-04-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-04-14", "Last_Update_Posted(Estimated)" : 2019-09-09", "Last_Verified" : 2019-09" } }}

#Study Description Brief Summary The purpose of this study is to evaluate if anodal tDCS stimulation over M1 may decrease chronic knee OA pain in elderly subjects with defective CPM. In addition, this trial will help to investigate the role of central sensitization in knee OA and evaluate how tDCS stimulation may affect it. #Intervention - DEVICE : Active Transcranial Direct Current Stimulation (tDCS) - Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. During active stimulation, the current will be active for the full 20 minutes. - DEVICE : Sham Transcranial Direct Current Stimulation (tDCS) - Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. However, during sham stimulation (placebo) the current will not be active for the full 20 minutes

#Eligibility Criteria: Inclusion Criteria: * Individuals > 60 years, of both genders. * Diagnosis of primary knee osteoarthritis with chronic pain self-reported. * Be able to sign the informed consent to participate in the study. * Chronic pain (over the past 6 months) of at least 4 on a 0 <= age <= 10 VAS scale on average. * Reduction on VAS (visual analogic scale) during CPM (conditioned pain modulation) < 10% Exclusion Criteria: * Contraindications to transcranial brain stimulation, i.e. implanted brain medical devices or implanted brain metallic devices. * Severe acute or chronic decompensated disease. * Cognitive and behavioral impairment. * Epilepsy. * History of fractures in the lower limbs and/or spine in the last 6 months. * Use of carbamazepine within the past 6 months as self-reported. * Severe depression (with a score of >30 in the Beck Depression Inventory) * History of syncope. * Traumatic brain injury with residual neurological deficits. * History of alcohol abuse within the past 6 months as self-reported. Sex : ALL Ages : - Minimum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03117231

{ "NCT_ID" : "NCT03100981", "Brief_Title" : "Online Mindfulness for Women Treated for Breast Cancer and Men Treated for Prostate Cancer", "Official_title" : "Internet-delivered Mindfulness-Based Cognitive Therapy for Symptoms of Depression, Anxiety, and Stress Among Women Treated for Breast Cancer and Men Treated for Prostate Cancer - Effects and Mechanisms", "Conditions" : ["Anxiety Depression", "Breast Cancer Female", "Prostate Cancer"], "Interventions" : ["Behavioral: Internet-delivered Mindfulness-Based Cognitive Therapy", "Behavioral: Waitlist control"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-02-24", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-11-27", "Study_Completion_Date(Actual)" : "2018-06-27}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-03-16", "First_Posted(Estimated)" : 2017-04-04" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-03-29", "Last_Update_Posted(Estimated)" : 2019-01-08", "Last_Verified" : 2018-10" } }}

#Study Description Brief Summary AIM: The aim of the present study is to investigate if Internet-delivered Mindfulness-Based Cognitive Therapy (I-MBCT) can reduce symptoms of depression and anxiety among women treated for breast cancer and men treated for prostate cancer compared to a treatment as usual control group. Furthermore, the effect of I-MBCT on symptoms of stress, insomnia, quality of life, and self-compassion and the potential mediating effect of working alliance and mindfulness will be explored. Finally, the cost-effectiveness of the I-MBCT intervention will be explored. BACKGROUND: Symptoms of depression, anxiety, and stress are prevalent late-effects among cancer patients and -survivors. Mindfulness-based interventions aim at improving affect tolerance and emotion regulation, which could be of particular relevance for cancer patients and survivors, and MBCT has been shown efficacious in treating symptoms of depression, anxiety, and stress among cancer patients and survivors. However, the availability of face-to-face delivered MBCT is limited and hence using the internet to deliver MBCT may be a cost-effective way of increasing the accessibility of the intervention to vulnerable patients with limited resources. METHODS: A total of 155 participants will be recruited from Department of Oncology and Department of Urology at Aarhus University Hospital and randomized to two groups: I-MBCT and a treatment-as-usual wait-list control group. Assessments will be conducted at pre-, midway and post intervention and at a 6- months follow-up. Detailed Description BACKGROUND Symptoms of depression, anxiety, and stress is common among both cancer patients and cancer survivors and can lead to prolonged hospitalization, reduced quality of life, and deteriorate prognosis. In Mindfulness-Based Cognitive Therapy (MBCT) participants practice attention towards the present moment and acceptance of feelings and physical discomfort. This is in particular relevant for cancer patients and -survivors who often experience psychological symptoms connected to negative thoughts about the past and worries about the future. MBCT is an 8-week group intervention and has shown to be effective in treating psychological distress in cancer survivors. Many cancer survivors experience challenges in following a group intervention because of health related reduced mobility and work- and family schedule conflicts, and hence it is relevant to investigate an internet-delivered alternative to MBCT. I-MBCT is a manualized treatment for breast- and prostate cancer survivors, based on the manual for Mindfulness-Based Cognitive Therapy for depression. I-MBCT consist of 8 weeks of mindfulness practice combined with reading theory and supported by weekly text messages and answers from a therapist. AIMS AND HYPOTHESES In a randomized controlled trial the efficacy of 8-weeks I-MBCT for breast- and prostate cancer survivors will be investigated. 1. The primary aim of the study is to investigate if Internet-delivered Mindfulness-Based Cognitive Therapy (I-MBCT) will reduce symptoms of depression and anxiety among women treated for breast cancer and men treated for prostate cancer and that the effect is remained at 6 months after the treatment. 2. The secondary aim is to explore the effect of I-MBCT on symptoms of stress, insomnia, and quality of life. 3. Furthermore, the study aims to explore the potential mediating effect of working alliance, self-compassion, and mindfulness. 4. Finally, the cost-effectiveness of the I-MBCT intervention will be explored. PARTICIPANTS AND PROCEDURES A total of 155 breast- and prostate cancer survivors are consecutively recruited from Aarhus University Hospital, Denmark. Staff at the Outpatient Clinics at Department of Oncology and Department of Urology will screen patients for psychological distress at follow-up check-ups. If the patients indicates a moderate to high level of psychological distress, further information about the project will be given and patients can sign up for study enrollment. Participants will after initial screening receive a phone call from a project staff to clarify if inclusion criteria are met. After informed consent all participants will fill out the online baseline questionnaire and then be randomized to either I-MBCT or a wait-list control group receiving treatment as usual in a ratio of 7:3 by means of a computer-generated randomization list. Participants fill out online questionnaires at baseline, midway (after 5 weeks), post treatment (after 10 weeks) and at follow-up after 6 months. The intervention group receive the 8-weeks of therapist-assisted I-MBCT which contains assessment of the Therapeutic Alliance at 2, 4, and 7 weeks after treatment onset. The statistical evaluation of the effect I-MBCT compared to the waitlist control will be performed with Multilevel Linear Models and post-hoc tests. The possible mediating effects will be evaluated using Preacher \& Hayes bootstrapping method. All analyses will be performed with a two-sided significance level of .05. REGISTRATION DETAILS The study record reported in ClinicalTrials.gov is completely consistent with the protocol approved by the Central Region Denmark Committee on Health Research Ethics before enrollment start. The study was registered in ClinicalTrials.gov after enrollment had started but before any data analysis was initiated. #Intervention - BEHAVIORAL : Internet-delivered Mindfulness-Based Cognitive Therapy - Internet-delivered Mindfulness-Based Cognitive Therapy is a trainer-assisted course based on the manual for Mindfulness-Based Cognitive Therapy for depression. The course consists of 8 modules, one per week, for 8 weeks and one additional week for flexibility for the participants. In total 9 weeks with weekly written contact to the personal instructor. Each module has an overall theme with written theory, approximately 45 minutes of daily mindfulness practice and other daily assignments with the purpose of strengthening awareness in the everyday life. - Other Names : - Mindfulness-Based Cognitive Therapy, I-MBCT, MBCT - BEHAVIORAL : Waitlist control - Participants in the control arm of the study will receive treatment as usual, which means that they are not offered interventions targeting psycho-social distress but also not prevented from participating in or seeking other psycho-social treatment during the course of the study. After the 6-months follow-up time has passed participants will get the opportunity to participate in 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy, if the intervention is found efficient. - Other Names : - Treatment as usual

#Eligibility Criteria: Inclusion Criteria: * Man treated for prostate cancer or woman treated for breast cancer * Active cancer treatment must have been completed (radiation therapy, operation and chemotherapy) within the past 5 years. Ongoing endocrine therapy is all right. * A minimum score of 3 on anxiety and/or depression items from Symptom Check-List-8, subscale in Common Mental Disorder Questionnaire (SCL-8, CMDQ). * Internet access on a daily basis * Must have a cell phone Exclusion Criteria: * Cancer recurrence or ongoing cancer treatment. * Problems with reading and/or understanding Danish * Insufficient IT skills * Severe mental illness causing problems with following the internet-delivered treatment, e.g. dementia, known psychotic disorder or developmental disorder. 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

NCT03100981

{ "NCT_ID" : "NCT05974215", "Brief_Title" : "Peri Implant Marginal Bone Height and Bone Density", "Official_title" : "Peri Implant Marginal Bone Height and Density Supporting Different Prosthesis Restoring Single Edentulous Mandible", "Conditions" : ["Implant Site Reaction"], "Interventions" : ["Device: assessment of change in bone height by cone beam computed tomography"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2023-04-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-07-01", "Study_Completion_Date(Actual)" : "2023-07-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2023-07-26", "First_Posted(Estimated)" : 2023-08-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-07-26", "Last_Update_Posted(Estimated)" : 2023-08-08", "Last_Verified" : 2023-08" } }}

#Study Description Brief Summary This study aims to evaluate the effect of mandibular implant supported removable overdenture on bone height and density and compare it with implant supported fixed overdenture in single mandibular overdenture. Detailed Description In this study 10 patients will be selected following inclusion and exclusion criteria. In each group 5 patients (each patient will receive 6 implants) will be divided randomly into two groups. Group I patients will receive mandibular implant supported removable overdenture, while Group II will receive mandibular implant supported fixed overdenture. All patients will be given the usual home care instructions about wearing and caring of dentures and opposing arch. Regarding dentures, removal of them at night and cleaning with denture brush and mild soap will be required. Measurements of Bone height and Bone density will be obtained by using Cone Beam Computed Tomography (CBCT). Measurements will be obtained at denture insertion, after 1 month and after 3 months. #Intervention - DEVICE : assessment of change in bone height by cone beam computed tomography - bone height was measured at 1 ,30 ,90 days after denture insertion

#Eligibility Criteria: Inclusion Criteria: * Non-smoker Patients * Highly cooperative and motivated patients. * Patients Systemically free from any immunosuppressive diseases. Exclusion Criteria: * Diabetic, hypertensive, cancer patients. * Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions and foreign bodies. * Patients with temporo-mandibular joint disorders and bad oral habits. Sex : MALE Ages : - Minimum Age : 40 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT05974215

{ "NCT_ID" : "NCT05690451", "Brief_Title" : "Non-contrast Abbreviated MRI for Secondary Surveillance of HCC", "Official_title" : "The Role of Non-contrast Abbreviated MRI for Secondary Surveillance of Hepatocellular Carcinoma After Curative Treatment: a Prospective Multicenter Study", "Conditions" : ["Hepatocellular Carcinoma"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-12-28", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-06-22", "Study_Completion_Date(Actual)" : "2024-06-22}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-12-28", "First_Posted(Estimated)" : 2023-01-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-01-10", "Last_Update_Posted(Estimated)" : 2024-06-25", "Last_Verified" : 2024-06" } }}

#Study Description Brief Summary This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT. Detailed Description This study was designed as a prospective single-arm intra-individual comparison multicenter study #Intervention - DIAGNOSTIC_TEST : non-contrast abbreviated MRI - Liver MRI without contrast injection. The following sequences will be obtained from all of the participants. * Axial heavily and regular T2 WI * precontrast fat-suppressed T1 WI * Diffusion-weighted image using b-value of 0, 50 or 400, and 800 or 1000 - DIAGNOSTIC_TEST : Contrast enhanced liver CT - Liver CT with iodine contrast injection This test will be served as a standard diagnostic test. The following phases will be obtained * precontast, arterial phase, portal venous phase and delayed phase

#Eligibility Criteria: Inclusion Criteria: * Age between 20-year old and 85-year old * Patients with a history of curative treatment for HCC including surgical resection or local ablation * No recurrence after curative treatment of HCC for more than two years * Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC) Exclusion Criteria: * Estimated GFR less than 60 * Previous history of severe allergic reaction to the iodinated contrast agent * Patients with claustrophobia who can't undergo MR examination * Patients having cochlear implants or cardiac pacemaker 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

NCT05690451

{ "NCT_ID" : "NCT00186407", "Brief_Title" : "Autologous Stem Cell Rescue for Primary Amyloidosis", "Official_title" : "High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis", "Conditions" : ["Amyloidosis", "Blood and Marrow Transplant (BMT)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "1998-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-02", "Study_Completion_Date(Actual)" : "2010-02}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2005-09-13", "First_Posted(Estimated)" : 2005-09-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2005-09-13", "Last_Update_Posted(Estimated)" : 2010-09-14", "Last_Verified" : 2010-09" } }}

#Study Description Brief Summary To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis. Detailed Description To learn about the use of high dose chemotherapy followed by transplantation using peripheral blood stem cells. #Intervention - PROCEDURE : high dose chemo then auto hematopoietic cell transplant

#Eligibility Criteria: Inclusion Criteria:1. Primary amyloidosis * Age < 75 years. * Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. * Patients who have undergone bone marrow transplantation previously will not be eligible. * Patients must have a Karnofsky performance status greater than 70%. * Patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction >45% on echocardiography, cardiac index > 1.8 liters/min/m^2 and pulmonary function tests demonstrating FEV1 and DLCO > 60%. * Patients must be HIV negative. * Pregnant or lactating women will not be eligible to participate. * Patients must provide signed informed consent. * Patients with multiple myeloma and amyloid are eligible. Exclusion Criteria:1. prior blood or marrow transplant 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

NCT00186407

{ "NCT_ID" : "NCT05037071", "Brief_Title" : "Arm Compression on Muscle Oxygen Saturation", "Official_title" : "The Impact of Upper Body Compression Wear on Muscle Tissue Oxygen Saturation During Video Game Play in Competitive Gamers.", "Conditions" : ["Muscle; Fatigue, Heart"], "Interventions" : ["Device: Upper body graduated compression sleeve"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional_Model" : "CROSSOVER", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2021-11-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-12", "Study_Completion_Date(Actual)" : "2022-01-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-08-31", "First_Posted(Estimated)" : 2021-09-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-08-31", "Last_Update_Posted(Estimated)" : 2022-01-31", "Last_Verified" : 2022-01" } }}

#Study Description Brief Summary This study is designed to observe muscle oxygen saturation during intense video game using gridlock training with and without upper arm compression sleeves. Detailed Description A competitive esport player can perform up to 500-600 mouse and keyboard actions per minute (APM) on a typical training day. A routine training day for a competitive esport player can range from 5- 10 hours of play with no break. In comparison, office workers perform an average of 130-180 keyboard and mouse inputs over the course of an 8 hour work day. These APM's require sustained wrist extension in conjunction with repetitive forearm muscle contractions in multiple planes, as well as shoulder stability and postural stability. Maneuvering a mouse and keyboard requires repeated contractions of the extensor carpi ulnaris and extensor digitorum. With these fine motor demands, it is common for players to suffer from acute and chronic overuse wrist and arm injuries. Muscle tissue oxygenation (Sm02) saturation is important to all athletic populations including endurance athletes and power athletes. It's a marker of how efficient that muscle is performing. A decrease in Sm02 indicates less ATP to that muscle and fatigue. Muscle deoxygenation and reoxygenation has been studied in multiple athletic populations. In competitive rock climbers, a lesser rate of deoxygenation of the finger and wrist extensor muscles was related to a higher level of climbing ability. The use of compression wear has expanded from clinical use into the sports market. The recommendations to wear compression gear in athletes is based on improvement in venous blood flow which improves exchange of fresh blood and blood waste. The research on its use on improving running performance has been mixed. Anecdotally, in 2001 Allen Iverson of the National Basketball Association (NBA) wore a compression arm sleeve to prevent swelling and provide relief of bursitis in his elbow. Lebron James of the NBA and London marathon runner Paul Radcliffe both swear by compression gear. In the 2016 Olympics, it was estimated that 90% of athletes used some form of compression performance gear. The compression wear sports industry market is a billion-dollar industry projected to be worth 3.96 billion dollars by 2022. Athletes in various sports wear compression garments with the assumption that it will improve performance and facilitate muscle recovery. Most modern compression gear marketed toward athletes use 'graduated compression'. This means that the highest amount of pressure is on the most distal parts of your body (e.g ankles if you are using lower body compression) and the pressure gradually reduces as it moves up toward your body. Compression wear varies in pressure range. The measurement is measured in mmHg and light compression can range from 18-21 mmHg, moderate 23-32 mmHg, strong 34-46 mmHg and \> 49 mmHg very strong. (6) Most over the counter athletic compression garments range from 18-21 mmHg. With esports literature in its infant stages, oxidative capacity of the finger and wrist extensors during prolonged gaming have never been explored. The aim of this study is to compare changes in tissue oxygenation of the wrist extensor muscles with and without graduated arm compression during competitive game play. #Intervention - DEVICE : Upper body graduated compression sleeve - An over the counter light compression sleeve will be worn during game training

#Eligibility Criteria: Inclusion Criteria: * A ranked esport player with over 500 hours in your game * Non-smoker * No history of heart disease * No history of pulmonary disease * No history of metabolic disease including diabetes Exclusion Criteria: *taking any prescribed or over the counter medications that would influence metabolic outcomes or blood viscosity. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 35 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT05037071

{ "NCT_ID" : "NCT02226536", "Brief_Title" : "Vestibular Dysfunction and Glucose Metabolism", "Official_title" : "Fractionated and Restrictive Glucose Diet in Patients With Vestibular Dysfunction: a Randomized Controlled Trial", "Conditions" : ["Dysfunction of Vestibular System", "Glucose Intolerance"], "Interventions" : ["Behavioral: fractioned diet without glucose"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2005-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-12", "Study_Completion_Date(Actual)" : "2011-12}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-08-06", "First_Posted(Estimated)" : 2014-08-27" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-08-26", "Last_Update_Posted(Estimated)" : 2022-06-14", "Last_Verified" : 2022-06" } }}

#Study Description Brief Summary Introduction: the global sugar consumption has increased in the past 50 years and their abusive intake is responsible for the insulin resistance and causes the metabolic syndrome - obesity, diabetes mellitus, hypertension and coronary heart disease. Objective: To evaluate the effect of scheduled diet without glucose as treatment of labyrinthine disorders associated with glucose-insulin index. Study Design: A prospective randomized controlled trial. Patients and Methods: A study conducted at the University of São Paulo with 51 patients divided into two groups: Diet Group (DG) that comprises subjects treated with fractionated diet with glucose restriction and control group (CG) where individuals were not counseled regarding diet. Patients underwent computerized dynamic posturography - sensory organization test (CDP - SOT) and Visual Analog Scale (VAS) in the first and thirtieth days of the study. Detailed Description 51 patientes with dizziness and glucose intolerance diagnosed by the glucose tolerance test were selected. The subjects were submited to CDP SOT conditions and a visual analogue scale to measure his self perception about dizziness. Then, they were randomized in two groups: with and without fractioned diet without glucose during 30 days. The CDP was repeated in order to verify a statistical difference of SOT condition 5 that reflects the individual hability to maintain the own posture with the vestibule solely and CS - that represents the final balance situation. The VAS was repeated too in order to verify the self perception of the dizziness after diet. #Intervention - BEHAVIORAL : fractioned diet without glucose - Patients were divided into two groups: Diet Group was treated with placebo pills and glucose restrictive and fractionated diet. Control Group received only placebo pills. All individuals had their vestibular function evaluated by Computerized Dynamic Posturography and done visual analogue scale (VAS) in the first day and 30 days after diet intervention

#Eligibility Criteria: Inclusion Criteria: * dizziness related to fasting or glucose intake * alterations of glucose tolerance test Exclusion Criteria: * dizziness not related to vestibular problems * ortopedical or neurological diseases * diabetes mellitus 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

NCT02226536

{ "NCT_ID" : "NCT04468451", "Brief_Title" : "Does Dosage Matter: Ride-on Cars to Enhance Social-mobility Function and Motivation in Toddlers With Motor Disabilities", "Official_title" : "Does Dosage Matter: A Randomized Controlled Trial of ride-on Car Training With a Standing Posture to Enhance Social-mobility Function and Motivation in Toddlers With Motor Disabilities", "Conditions" : ["Mobility Limitation"], "Interventions" : ["Behavioral: A regular therapy program without receiving any ROC training", "Behavioral: A 24-hour ROC training program with a standing posture", "Behavioral: A 48-hour ROC training program with a standing posture"], "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)" : "2020-08-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-05-05", "Study_Completion_Date(Actual)" : "2022-07-29}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-07-08", "First_Posted(Estimated)" : 2020-07-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-07-10", "Last_Update_Posted(Estimated)" : 2024-02-07", "Last_Verified" : 2024-02" } }}

#Study Description Brief Summary Modified ride-on toy cars (ROCs) have been viewed as one Maker Movement and become an innovative, alternative option to enhance independent mobility and socialization in young children with disabilities in the recent years. To increase the applicability of this novel intervention, this study proposes a modified ROC-training program with a less-intensive dose which may be an effective and a more feasible protocol for clinical therapists and caregivers to implement. The three purposes of this study are: 1) to compare the effectiveness of different dosages of ROC training with a standing posture on social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; 2) to determine the optimal dosage of ROC training with a standing posture that is needed to enhance social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; and 3) to examine the effects of different dosages of ROC training with a standing posture on the ICF functioning levels, family perceptions and participation. Based on the power analysis from the preliminary results of our RCT study, the investigator will recruit 45 children with disabilities who are between 1 to 3 years old and diagnosed as motor delay. They will be randomly assigned to one of the following three groups: a 48-hour ROC training program with a standing posture (ROC-48) (n=15), a 24-hour ROC training program with a standing posture (ROC-24) (n=15), and a regular therapy program without additional training (n=15). The whole study duration will be 24 weeks, including 12-week intervention and 12-week follow-up. The ROC-48 and ROC-24 programs will include 2 sessions/per week, each session for 1 hour (ROC-24) or 2 hours (ROC-48) training. All participants will continue their regular therapy during the whole study. Standardized assessments are provided for a total three times, including the time before and after the intervention and in the end of the follow-up phase. Assessments include social mobility, mastery motivation, behavioral coding, body function, family perception and participation. The use of modified toy cars with different dosages will provide the family and therapists a set of novel, alternative ways to increase family participation and facilitate development in toddlers with disabilities, depending on children's and family's needs. Detailed Description There is increasing evidence of early power mobility training in recent years, which focuses on the outcomes of motivation and socialization by using standardized measurements, including the Dimensions of Mastery Questionnaire (DMQ), the pediatric evaluation of disability inventory (PEDI) and its' computer adaptive test. These studies showed the use of PMDs might increase the child's independent mobility and motivation to master interpersonal tasks and result in positive changes on psychosocial functioning. Previous studies have determined the feasibility of using a modified ride-on car (ROC) as an alternative, novel option for early mobility training to improve independent mobility and socialization in children aged younger than 3 years. Of note is that this technology-focused do-it-yourself (DIY) movement has provided concrete solutions for children with disabilities, which emphasizes 'learning by doing' and is called 'the Maker Movement'. Awori and Lee has viewed the process of modifying the ROCs and applying relevant training as one Maker Movement. Due to the participatory model of innovation, there are over 60 workshops worldwide that have built approximately 5000 ride-on toy cars. In addition to this universal trend of hands-on practice for health innovation, the use of ROCs may result in the significant improvements in motivation and physical activity in young children with motor disabilities. Kenyon and colleagues reported that pediatric occupational therapists and physical therapists in Canada and the USA recognized the potential benefits of applying power mobility training in young children who have mobility impairments. In addition, almost all therapists agreed or strongly agreed that time and practice were equally as important as a child's abilities when applying power mobility training. However, 69% of these therapists never or seldom provided these types of experiences to children in their practice. The amount and type of practice may play an important role while making the clinical decision. Based on the increased evidence for children with motor disabilities in the past 10-15 years, researchers have suggested that the type of treatment may matter less than the amount of treatment (dosage). The idea of providing an intervention at an amount of greater than standard care has generally been conceptualized with the terms 'intensity or intensive treatment'. Up to now, several ROC studies have suggested intensive dose of therapy may be effective on improving social-mobility function and mastery motivation. Although the participants were able to complete the 12-week training, the caregivers felt it may be difficult to implement such program in their clinical settings. Our previous pilot results have shown that 85% of the caregivers preferred a 1-hr program than a 2-hr program due to the family resources and geographical concerns. The current ROC training program typically involves long length (9-12 weeks), high frequency (2 sessions per week) and duration (2 hours per session). However, the high frequency and duration may not be a feasible protocol for therapists and caregivers. In addition, there is no study comparing the same type of ROC training at contrasting doses and therefore could not address the relative effectiveness of different doses of therapy. A further study with the comparison of different doses of training may help to determine the optimal program for enhancing social-mobility and psychosocial functions in toddlers with motor disabilities. It is important to consider the clients' needs and incorporate the suggestions into the training protocol based on the evidence. To integrate the caregivers' feedback and increase the applicability of the ROC training program, the investigator further propose a modified program of using the ROC with less-intensive doses, i.e., a 1 hour session of 30-to-35-minute standing-driving for exploration and 25-minute natural play for exploration and skills training. The investigator assume the less-intensive dose of the ROC training will also have positive effects on social-mobility function and other ICF levels due to the sufficient amount of practice suggested by previous evidence (at least 20 to 60 min. moderate to vigorous intensity/per session, 2 sessions/per week). A 3-group comparison design of different doses of ROC training with a standing posture may provide us a complete examination on the topic of dose-response effect on mobility and psychosocial function in toddlers with disabilities. In this study, the investigator will modify the ride-on toy car (standing style) for toddlers with disabilities for the use in the public spaces in the university for 12 weeks based on our previous RCT study. This RCT will compare the improvements of social-mobility function, mastery motivation and physical activity resulting of different dosages for the ROC use with a standing posture. A control group which receives no ROC training and only involves regular therapy will be applied as an active control group. The specific aims of this study are: 1) to compare the effectiveness of different dosages of ROC training with a standing posture on social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; 2) to determine the optimal dosage of ROC training with a standing posture that is needed to enhance social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; and 3) to examine the effects of different dosages of ROC training with a standing posture on the ICF functioning levels, family perceptions and participation. Study Design: A randomized, multiple group pretest-posttest control group design will be applied.62 Three groups will be involved in this novel project: the dosage of a 48-hour ROC training program with a standing posture (ROC-48), the dosage of a 24-hour ROC training program with a standing posture (ROC-24), and a regular therapy program without receiving any ROC training (control). The participants will be randomly assigned to one of the 3 groups by using a computer program (Research Randomizer Form www.randomizer.org). The study duration for each participant is 24 weeks, including 12-week intervention and 12-week follow-up. Recruitment: The participants will be recruited from self-referrals, health care practitioners, or the hospitals in Taipei or Taoyuan where toddlers with motor delays are receiving outpatient rehabilitation. The research team will contact the parent/guardian to explain study details and provide them the opportunity to ask questions. Parents will receive a letter detailing the procedure; children of parents/guardians who provide informed consent will participate in the study. Procedure: Before the pre-intervention assessments, the research team will modify the car's seat and acceleration to the hand switch-driven. After modifications, they will receive pre-intervention measurements, including developmental assessments, behavioral videotaping and self-developed questionnaires. These assessments will occur on three occasions: before and after the 12-week intervention (T1 \& T2) and the end of the 12-week follow-up phase (T3). During the 12-week intervention, the social-mobility behaviors for the 2 ROC training groups will also be videotaped by the research team for 1 hour during one session/per week at the university. In addition, participants will wear three accelerometers on their wrists and right hip to monitor the minutes of exercise, postural change, activity counts and energy expenditure for exploration during one training session/each week for 12 weeks. An activity log used in the previous studies will also be applied to record the driving and play duration, driving locations, and the caregiver's feedback on the training program every week. Intervention: The research team will ask caregivers to identify goals (before intervention), and measure progress using goal-attainment scaling (GAS) at T1 and T2 time points for the 2 ROC training groups. An independent licensed occupational therapist who will not involve the administration of assessments will provide the intervention with the caregivers. The training principles are similar to those applied in our previous studies of ROC training in various environments. To record the total driving time, locations, and caregivers' feedback regarding training, an activity log will be used for each week. All groups will continue their regular therapy from their own therapists throughout the 24-week duration of the study, including physical therapy, occupational therapy, and speech therapy. The research team do not provide regular therapy during the study. On licensed, independent OT will provide the ROC training programs for the two ROC training groups. The ROC-48 will receive the program in the university for 2 hours/per session, 2 sessions/per week for a total of 12-week intervention. For the ROC-24 group, the participants will have a 30-to-35-minute car play and a 25-minute natural play and the frequency is 2 sessions/per week for a total of 12 weeks. The training programs for the two ROC training groups will be based on the ecological and dynamic systems theory. All the programs will be discussed by the family, the treating therapist and the research team. The program for the control group will only involve their regular therapy provided by their own clinical therapists. Follow-up: This period will involve a 12-week phase following the above treatment programs; during this time no treatment programs will be delivered to the participants except for their own regular therapy. Data Reduction and Analysis: Social-mobility measures will be obtained every week during the intervention phase, including the simultaneous co-occurrence of self-directed locomotion and direct adult interaction, and operationalized as number of minutes observed. All data records will exclude names to provide anonymity of the participant. Two independent coders will code all the videotapes related to social-mobility and mastery motivation performances. In addition, they will determine the physical activity for exploration by combining the data from activity monitors and the videotapes. All the coding criteria of social-mobility and mastery motivation are established based on the previous studies. Descriptive statistics including frequency, means, standard deviations, as well as nonparametric data medians and interquartile ranges will be calculated. Kolmogorov-Smirnov will be used to examine whether the data follows a normal distribution. To compare the baseline characteristics of the 3 groups, one-way ANOVA (for data with normal distribution) and Kruskal-Wallis test (for data with non-normal distribution) will be conducted. If there is a significant difference among the 3 groups, the specific baseline characteristics will be analyzed and further determined as the co-variate for the subsequent analysis, e.g., regular therapy. Data will be analyzed based on an intention-to-treat analysis. A repeated measures analysis of variance (group \[3\] × time \[3\]) will be employed to evaluate the treatment effects on the primary and secondary outcomes among the 3 groups at T1, T2, and T3, followed by a post-hoc analysis using Bonferroni test to determine between which groups the differences occur. SPSS 20.0 (SPSS Inc. Chicago, Illinois, USA) will be used for statistical analysis. Significance level will be set at p \< 0.05. #Intervention - BEHAVIORAL : A 48-hour ROC training program with a standing posture - The 2-hour training session is composed of two 30-minute driving sessions and two 25-minute natural play sessions, with a 10-minute break. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session. - BEHAVIORAL : A 24-hour ROC training program with a standing posture - The 1-hour training session is composed of a 30-to-35-minute car play and a 25-minute natural play. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session. - BEHAVIORAL : A regular therapy program without receiving any ROC training - The regular therapy group will be an active control group without receiving any additional training. The training dosage will be their own therapy, including occupational, physical and speech therapy. They will continue their regular therapy, including physical, occupational and speech therapy. The general propose of the training is to improve the developmental scales, mobility, socialization and upper limb use in functional tasks.

#Eligibility Criteria: Inclusion Criteria: * 1. motor delays that resulted in motor impairments that prevented independent walking (standard deviation (SD) < -1.5, assessed by the Chinese Child Development Inventory (CCDI) via a pediatric physician) 2. can stand independently for two seconds or to tolerate standing with support for 10 minutes 3. can reach for objects/toys with either one or two hands 4. the height is between 69 to 103 cm and the weight is between 7 <= age <= 18 kg 5. parents are able to provide consent for their child's participation in training programs Exclusion Criteria: * 1. children with severe sensory impairments such as blindness, deafness 2. the height is not between 69 to 103 cm and the weight is not between 7 to 18 kg 3. parents/caregivers are not able to make a time commitment for the training phase Sex : ALL Ages : - Minimum Age : 12 Months - Maximum Age : 36 Months - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT04468451

{ "NCT_ID" : "NCT01976481", "Brief_Title" : "Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27", "Official_title" : "Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27", "Conditions" : ["Skin Toxicity"], "Interventions" : ["Device: sunbed exposure"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2013-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-12", "Study_Completion_Date(Actual)" : "2015-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2013-10-29", "First_Posted(Estimated)" : 2013-11-05" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-10-29", "Last_Update_Posted(Estimated)" : 2016-08-03", "Last_Verified" : 2015-08" } }}

#Study Description Brief Summary Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27. The use of a sunbed will be compared to a control group not using a sunbed in the observation period. * Trial with medical device Detailed Description We will compare to baseline changes in serum vitamin D and health-related quality of life using a control group and an intervention group. #Intervention - DEVICE : sunbed exposure - exposure to sunbed ultraviolet radiation

#Eligibility Criteria: Inclusion criteria: Probands intending to use a commercial sunbed : * Age >= 18 years * Regular use of commercial sunbeds * Oral and written informed consent Exclusion criteria: 1. Skin type I according to Fitzpatrick according to EU guideline EN 60335 <= age <= 2-27 2. Sunbed use within the last three months 3. Use of vitamin D supplements or multivitamin supplements 4. Any medical condition which renders them unfit for sunbed use in the judgment of the investigator 5. Inability to provide oral and written consent to participate 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

NCT01976481

{ "NCT_ID" : "NCT03806972", "Brief_Title" : "Short and Long Term Prognosis of Patients Admitted to the ED With Acute Heart Failure", "Official_title" : "Short and Long Term Prognosis of Patients Admitted to the Emergency Department With Acute Heart Failure", "Conditions" : ["Acute Heart Failure"], "Location_Countries" : ["Tunisia"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-06-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-10-01", "Study_Completion_Date(Actual)" : "2021-10-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-01-15", "First_Posted(Estimated)" : 2019-01-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-01-15", "Last_Update_Posted(Estimated)" : 2021-10-13", "Last_Verified" : 2021-10" } }}

#Study Description Brief Summary Heart failure (HF) is the leading cause of hospitalization ,rehospitalization and mortality for adults over 65 years of age. This study aimed to assess mortality, and hospitalization rates at 30 days and one year after dicharge of patients with heart failure (HF) with reduced ejection fraction (HFrEF) compared to HF with preserved ejection fraction (HFpEF).

#Eligibility Criteria: Inclusion Criteria: * patients admitted to the ED of Monastir with a principal discharge diagnosis code for HF. Exclusion Criteria: * Pregnant or breast feeding women. Alteration of consciousness GCS < 15 Critically ill patients needing immediate mechanical hemodynamic of ventilatory support. Inability to follow instructions or comply with follow-up procedures. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT03806972

{ "NCT_ID" : "NCT01364467", "Brief_Title" : "The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study", "Official_title" : "The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study", "Conditions" : ["Chronic Rhinitis"], "Interventions" : ["Drug: Guaifenesin", "Drug: Placebo"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-03-05", "Study_Completion_Date(Actual)" : "2018-03-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-05-04", "First_Submitted_that_Met_QC_Criteria" : 2020-04-14", "First_Posted(Estimated)" : 2011-06-02" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-05-31", "Last_Update_Posted(Estimated)" : 2020-04-24", "Last_Verified" : 2020-04" } }}

#Study Description Brief Summary This is a 14-day, randomized, placebo-controlled, parallel group, masked clinical trial of oral guaifenesin for the therapy of Chronic Rhinitis (CRS) in 36 children between the ages of 7 and 18 years. The study investigates the effectiveness of guaifenesin in the relief of nasal symptoms in children with CRS using the sinonasal 5 survey (SN-5) in comparison to nasal airway volume, and biophysical properties of nasal secretion. The investigators hypothesize that Guaifenesin use over a period of 14 days improves subjective nasal complaints in pediatric patients with chronic rhinitis and nasal congestion, as measured by the SN-5 survey compared to use of placebo. There will be an observed improvement in nasal volume and cross-sectional area following use of guaifenesin, and nasal secretions will have more favorable mucociliary and sneeze clearability compared to use of placebo. #Intervention - DRUG : Placebo - Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID. - DRUG : Guaifenesin - Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.

#Eligibility Criteria: Inclusion Criteria: * Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal stuffiness for at least 3 month duration. Exclusion Criteria: * Children with immunodeficiency, cystic fibrosis, acute or subacute symptoms, signs of bacterial infection, and/or those who are unable to cooperate with testing will be excluded. Children with documented use of the study medication in the month before evaluation and during period of symptoms will also be excluded. Sex : ALL Ages : - Minimum Age : 7 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT01364467

{ "NCT_ID" : "NCT01344447", "Brief_Title" : "Gadobutrol Enhanced MRA of the Supra-aortic Vessels", "Official_title" : "Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels", "Conditions" : ["Carotid Stenosis"], "Interventions" : ["Drug: Gadobutrol (Gadovist, BAY86-4875)"], "Location_Countries" : ["France", "Sweden", "China", "United States", "Germany", "Poland", "Austria", "Australia", "Switzerland", "Argentina", "Italy", "Turkey", "Czechia", "Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-05-12", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-05-28", "Study_Completion_Date(Actual)" : "2014-05-28}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-04-05", "First_Submitted_that_Met_QC_Criteria" : 2015-07-29", "First_Posted(Estimated)" : 2011-04-29" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-04-28", "Last_Update_Posted(Estimated)" : 2019-01-04", "Last_Verified" : 2018-12" } }}

#Study Description Brief Summary Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required. This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study. MRA and CTA images will be collected for an independent review (blinded read). #Intervention - DRUG : Gadobutrol (Gadovist, BAY86-4875) - A single bolus injection of approx. 0.1mmol/kg

#Eligibility Criteria: Inclusion Criteria: * Male or female subjects, aged 18 years and older * Any of the following: * Known or suspected supra-aortic arterial disease based on: * Prior stroke * Transient ischemic attack (TIA) * Amaurosis Fugax (transient monocular blindness) * Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis) * Follow-up for a stent in a supra-aortic vessel * Prior imaging study (CTA or ultrasound) showing >= 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). The proportion of subjects with positive disease (determined by the investigator, based on CTA or ultrasound) will be monitored during the study, and enrolment may be further restricted to require >= 70% stenosis to ensure that overall there are an adequate number of subjects with clinically significant disease for the evaluation of study endpoints. * Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography [CE MRA] examination with gadobutrol * Willingness and ability to follow directions and complete all study procedures specified in the protocol * Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug Exclusion Criteria: * Pregnant or nursing (including pumping for storage and feeding) * Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study * Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol * Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI) * Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF]) * History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents * Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.) * Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.) * Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period * Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome * Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery) * Scheduled or potentially expected for the period between the CTA and gadobutrol MRA: * Any procedure that may alter the MRA or CTA interpretation, or * Any interventional or surgical procedure involving the supra-aortic vessels 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

NCT01344447

{ "NCT_ID" : "NCT02707380", "Brief_Title" : "The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation", "Official_title" : "The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation", "Conditions" : ["Type 2 Diabetes (T2DM)", "Cardiovascular Disease"], "Interventions" : ["Other: Standard of Care", "Other: Resistance Training"], "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)" : "2015-03", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-03", "Study_Completion_Date(Actual)" : "2016-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-02-22", "First_Posted(Estimated)" : 2016-03-14" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-03-11", "Last_Update_Posted(Estimated)" : 2016-03-31", "Last_Verified" : 2016-03" } }}

#Study Description Brief Summary This study is designed to investigate the effect of a structured resistance training program on glycemic control, measured by hemoglobin A1c (glycated hemoglobin), in patients with type 2 diabetes (T2DM) who are enrolled in outpatient cardiac rehabilitation. The investigator will compare the experimental group receiving resistance training to a control group made of patients enrolled in outpatient cardiac rehabilitation and perform 3 aerobic exercise modalities during their sessions, which is the current standard of care. #Intervention - OTHER : Resistance Training - 7 muscle-strengthening exercises using body weight resistance and elastic resistance bands - OTHER : Standard of Care - 3 exercises that do not include these 7 muscle-strengthening exercises

#Eligibility Criteria: Inclusion Criteria: * Diagnosis with T2DM and have been accepted for a standard outpatient cardiac rehabilitation program * Cognitively able to comprehend the information presented in the program * Cognitively able to give informed consent to participate in this study Exclusion Criteria: * Patients with orthopedic or neurological limitations that would prevent them from participating in the resistance training program or monitored exercise sessions. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02707380

{ "NCT_ID" : "NCT05144919", "Brief_Title" : "Biodiversity in the Diet in Vietnam", "Official_title" : "The Role of Agricultural Biodiversity in Thet Diet: a Vietnamese Study", "Conditions" : ["Biodiversity", "Food Intake", "Nutritional Status"], "Interventions" : ["Behavioral: Promotion of a biodiverse diet"], "Location_Countries" : ["Vietnam"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2015-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-12", "Study_Completion_Date(Actual)" : "2017-01}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-12-02", "First_Posted(Estimated)" : 2021-12-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-12-02", "Last_Update_Posted(Estimated)" : 2021-12-03", "Last_Verified" : 2021-12" } }}

#Study Description Brief Summary Agricultural biodiversity can have an important role in improving diet diversity, quality and nutrition and can be seen as the foundation of the food and nutrition value chain. Increasing the availability and access to local agricultural and/or wild biodiversity genetic resources has the potential to increase production, making more food available for consumption as long as entitlements to access it exist. However, as the history of food security interventions has shown, increasing the production and supply of staple crops alone is not enough to improve food security or nutritional status. However, while agricultural diversification is an important component, it is not alone sufficient to improve diet diversity. Other system elements including women's education and knowledge, intra-household dynamics and women's status and cultural beliefs and practices that improves children's health and nutrition are important to ensure biodiversity has a successful role in improving dietary diversity and quality. #Intervention - BEHAVIORAL : Promotion of a biodiverse diet - Component 1 - Participatory Identification of Intervention Approach (PIIA) Component 2. Local stakeholder consultation Component 3. Sensitisation of community Diversity club will receive capacity building from a Village health worker based on the prioritised species selected in component 2. The following topics will be covered for each species selected for promotion: 1. Where to locally source inputs and expected price 2. How/when to prepare plots using organic inputs 3. Planting and best-practice management practices 4. Seed saving and storage 5. Possible intercropping combinations OR ecosystem services provided Component 4. Active Cooking demonstrations and Nutrition Education and counselling: Diversified cooking practices

#Eligibility Criteria: Inclusion Criteria: * villages: Characterized as Thai village. Only Thai villages will be selected for the study as agriculture practices, diets, food preferences, language and cultures can change drastically between ethnic groups. * participants: i) Woman of reproductive age (between 15 <= age <= 49 years) who are the mother or primary caregiver of a child between 12 and 23 months of age. This age group is part of the critical 1000 day window for child development and marks the time when young children can potentially consume all foods from the household pot and consume a more diverse diet. As such, it is from this age group that biodiversity can have an effect on children's diets. ii) Both the woman and the child should be permanent residents in the village selected and do not temporarily migrate outside the village cluster during the year. Exclusion Criteria: * villages: Urban center of commune/province as these villages/cities do not have agriculture or home garden opportunities * participants: currently engaged in other agriculture or nutrition programme or intervention apart from what is offered by government extension workers Sex : ALL Ages : - Minimum Age : 6 Months - Maximum Age : 23 Months - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes

NCT05144919

{ "NCT_ID" : "NCT01029301", "Brief_Title" : "Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System for Skin Wrinkle Treatment on Body Areas", "Official_title" : "Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System", "Conditions" : ["Skin Aging", "Skin Wrinkling"], "Interventions" : ["Device: Device: EndyMed Pro System for Skin Tightening"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2008-11", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-11", "Study_Completion_Date(Actual)" : "2009-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-12-08", "First_Posted(Estimated)" : 2009-12-09" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-12-08", "Last_Update_Posted(Estimated)" : 2009-12-09", "Last_Verified" : 2009-12" } }}

#Study Description Brief Summary Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen modification, skin laxity and cellulite (dermis and hypodermis). EndyMed has developed the EndyMed Pro system - Computerized Radiofrequency System for Skin Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern can be produced allowing to selectively heating one or more of the target tissues (epidermis, dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be targeted, creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis. This post marketing study is intended for evaluation of safety and efficacy of the EndyMed Pro system. #Intervention - DEVICE : Device: EndyMed Pro System for Skin Tightening - Based on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed): Pulse energy (J); RF frequency (1MHz); Pulse duration (30 sec); Treatment hand piece (skin tightening);

#Eligibility Criteria: Inclusion Criteria: * Healthy males and females age 30 and up * Subjects with Fitzpatrick 4 to 9 degrees of elastosis * Subject able to comprehend and give informed consent for participation in this study * Subject must commit to all treatments and follow-up visits * Subject must sign the Informed Consent Form Exclusion Criteria: * Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder * Subjects with any implantable metal device in the treatment area * Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as 'Accutane', within the past 6 months * Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 6 months (in the treated area) * Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treatment area at the period of the study * Subjects who have any form of suspicious lesion on the treatment area * Subjects with history of keloid formations or hypertrophic scarring * Pregnant or lactating Subjects * Subjects with Epilepsy or severe migraines * Subjects with permanent makeup/ tattoo/ body piercing (in the treated area) * Subjects with any Infection / abscess / pains in treatment target area * Eczema or dermatitis * Subjects who suffer from autoimmune disorders or diabetes * Subjects using blood thinning medications * Subjects with clotting disorders * Subjects on drugs or psychologically determined unsuitable for the study * Subject is suffering extreme general weakness * Subject objects to the study protocol * Concurrent participation in any other clinical study * Physician objection Sex : ALL Ages : - Minimum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT01029301

{ "NCT_ID" : "NCT02197585", "Brief_Title" : "Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery", "Official_title" : "Cyanoacrylate vs Suture for Mesh Fixation in Inguinal Hernia Surgery", "Conditions" : ["Chronic Pain"], "Interventions" : ["Procedure: Inguinal mesh hernioplasty"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-06", "Study_Completion_Date(Actual)" : "2011-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-07-21", "First_Posted(Estimated)" : 2014-07-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-07-21", "Last_Update_Posted(Estimated)" : 2014-07-22", "Last_Verified" : 2014-07" } }}

#Study Description Brief Summary To compare fixation with glubran2 with suture during surgery por primary inguinal hernia. Hypothesis: Glue may induce less complications and chronic pain than suture #Intervention - PROCEDURE : Inguinal mesh hernioplasty

#Eligibility Criteria: Inclusion Criteria: * Male patients * Aged more than 18 years * Primary inguinal hernia Exclusion Criteria: * Inguinoscrotal hernia Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT02197585

{ "NCT_ID" : "NCT01437371", "Brief_Title" : "Is There a Benefit to Optimize Heart Failure (HF) Treatment in Aged Over 80 Year's Old Patients?", "Official_title" : "Is There a Benefit to Optimize HF (Heart Failure) Treatment in Aged Over 80 Year's Old Patients?", "Conditions" : ["Heart Failure"], "Interventions" : ["Drug: - Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril."], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-06", "Study_Completion_Date(Actual)" : "2014-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-08-31", "First_Posted(Estimated)" : 2011-09-20" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-09-19", "Last_Update_Posted(Estimated)" : 2014-10-01", "Last_Verified" : 2014-09" } }}

#Study Description Brief Summary The purpose of this study is to determine if there is an interest to optimize HF (heart failure) management in patients over 80 years old. The primary objective is to assess the effect of HF (heart failure) optimized management (guidelines of the European society of Cardiology (ESC) on Quality of Life (QOL) in aged over 80 year's old at 6 months. Detailed Description Aging population, and better management of various heart diseases including ischemic explain the growing up of incidence and prevalence of chronic heart failure. The aging of the population leads now to support services in cardiology and particularly in the units of heart failure in subjects over 80 years. It's a special population with several co-morbidities, in whom it is difficult to introduce all the recommended treatments with optimal doses. There is indeed a significant difference between the optimal doses of treatments tested in studies on heart failure and doses found on the orders of inpatients for HF (heart failure). Unfortunately clinical trials on heart failure have recruited young patients, mean age 65 years. Clinical studies in cardiology and particularly in heart failure recruit young subjects at the expense of seniors who are underrepresented in these studies. The investigators will compare two groups: the first one with an 'optimized' management and the second one as 'usual care'. The primary endpoint will evaluate the quality of life at 6 months according to the scale of Minnesota. Secondary outcomes will be the quality of life at 12 months, quality of life measured by the SF 12 (to check what level is most suited to this population) at baseline, 6 months and one year, mortality at 12 months, the number of re-hospitalization and cardiovascular events at 12 months, New York Health Association (NYHA) class (at baseline, 6 months and 12 months) and walking test for 6 minutes (at baseline, 6 months and 12 months). Finally the investigators plan to conduct an analysis on the medical and economic interest of this support. #Intervention - DRUG : - Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril. - The purpose of this study is to determine if there is an interest to optimize HF management in patients over 80 years old. The primary objective is to assess the effect of HF optimized management (guidelines of the European society of Cardiology (ESC) on QOL in aged over 80 year's old at 6 months

#Eligibility Criteria: Inclusion Criteria: * Aged over 80 year's old subjects * Hospitalized for an acute heart failure * Left Ventricle Ejection Fraction <= 35% * Evaluated life expectancy (Seattle HF score) > 1 year Exclusion Criteria: * Dementia * Does not understand French language * Followed with an optimized management * With reduced mobility * Recruited in another clinical trial or in a HF management network * AHF with curable aetiology : cardiovascular surgery for CABG or valvular replacement, angioplasty * MDRD < 30 ml/min/1.73m² Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT01437371

{ "NCT_ID" : "NCT04556994", "Brief_Title" : "Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.", "Official_title" : "Comparison of Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.", "Conditions" : ["Coronary Artery Disease"], "Interventions" : ["Other: Phase 1 Cardiac Rehabilitation", "Other: Phase 1 Cardiac Rehabilitation with Lower Limb Paddling"], "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)" : "2020-09-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-20", "Study_Completion_Date(Actual)" : "2020-12-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-09-16", "First_Posted(Estimated)" : 2020-09-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-09-16", "Last_Update_Posted(Estimated)" : 2021-01-13", "Last_Verified" : 2021-01" } }}

#Study Description Brief Summary To compare the effect of Phase 1 cardiac rehabilitation with lower limb paddling, with phase 1 cardiac rehabilitation without lower limb paddling Effects in Post Coronary artery bypass graft (CABG) Patients. Detailed Description Coronary artery disease (CAD) is the most common type of heart disease. CAD happens when the arteries that supply blood to heart muscle become hardened and narrowed. This is due to the buildup of cholesterol and other material, called plaque, on their inner walls. This buildup is called atherosclerosis. As it grows, less blood can flow through the arteries. As a result, the heart muscle can't get the blood or oxygen it needs. This can lead to chest pain (angina) or a heart attack. Most heart attacks happen when a blood clot suddenly cuts off the hearts' blood supply, causing permanent heart damage. Previous studies reported positive effects of early exercise in the ICU on these measures . In a meta-analysis published earlier, early mobilization increased the number of ventilator-free days during hospitalization, but not the duration of Minute ventilation (MV). A possible explanation is that many patients without MV were included . As a result, these results should be interpreted with caution. The mortality rate is a traditional measure of the health status of critically ill patients. Muscle weakness is associated with increased mortality. Physical therapy in the intensive care unit (ICU) had no effect on mortality in many previous systematic reviews and meta-analyses. Similar to previous studies, early mobilization did not improve ICU mortality, hospital mortality, or 28-day mortality rates in the previously published meta-analysis. The discharged-to-home rate is an important prognostic indicator for critically ill patients, first showed that early mobilization increased the discharged-to-home rate compared to the control group. In previous study it was concluded that, after the performance of the mobilization protocol, the patients in the Immunoglobulins (IG) improved the distance walked in the 6 min walk test (6MWT), which was assessed during 7 postoperative days and 60 days after hospital discharge, and it was less time in ICU and lower prevalence of pulmonary complications, when compared to the control group (CG). It was also concluded that with the results obtained from their study, it was possible to introduce an early mobilization protocol in the ICU routinely unit and sensitize the medical board about the importance of proper physiotherapy conduct. Another previously conducted study states that regardless of the different techniques and periods of mobilization applied, early mobilization may be initiated safely in the ICU setting and appears to decrease the incidence of Intensive care unit-acquired weakness (ICU-AW), improve the functional capacity, and increase the number of patients who are able to stand, number of ventilator-free days and discharged-to-home rate without increasing the rate of adverse events. However, due to the substantial heterogeneity among the included studies, the evidence has a low quality. Previous study states the importance of this approach; this has been emphasized in previous studies on experienced paddlers, rowers, cross-country skiers, cyclists and runners. However, some studies in sports that depend upon a high lower extremity documented a dependence of results from a specific Paddler on the season when the test was undertaken. During paddling, ventilatory functions are also very important. Values for the maximal minute ventilation (Vmax) and tidal volume obtained in the cycle ergometer were higher than in paddling in previous studies. During endurance performance the tidal volume depends on age, sex and constitutional factors and, in athletes, mainly on the nature and duration.The Max oxygen consumption (VO2) differences between maximal cycling and paddling were non-significant in previous studies. The ventilation equivalent affords insight into the economy of respiration. The magnitude is dependent on constitutional factors, especially on morphological conditions of the respiratory system, and partly on sex, age and, especially in athletes, on the economy of ventilation. #Intervention - OTHER : Phase 1 Cardiac Rehabilitation - Step 1:Breathing exercises, 3 sets of 10 repetitions. Active upper and lower extremity exercises, 3 sets of 10 repetitions; bed inclined at 45°. Step 2:Active exercises as in step 1. Stay in the upright position and perform walking on the spot for three series of 1 min. Step 3:Active exercises as in step 2. Ambulation within the inpatient wards (7 min). Transfer to an allocated chair beside the bed (at least 30 min). Step 4:Same exercises as in step 3. Ambulation within the inpatient wards (10 min). Transfer to an allocated chair beside the bed (at least 1 h). Step 5:Same exercises as in step 4. Ambulation within the inpatient wards (15 min). Transfer to an allocated chair beside the bed (at least 2 h). Step 6:Active exercises from the previous day. Ambulation within the inpatient wards (20 min). Step training (3 times continuously, 20 cm standardized step). Step 7:Exercises from the previous day. Step training (6 times continuously, 20 cm standardized step). - OTHER : Phase 1 Cardiac Rehabilitation with Lower Limb Paddling - Step 1 to step 6 of Phase 1 Cardiac Rehabilitation given to the patients along with Lower limb exercise on Paddler lasting 20 min (5-min warm-up, 10 min of low-intensity exercise, and 5-min recovery), 30 rpm ( rotation per minute)

#Eligibility Criteria: Inclusion Criteria: * Body mass index (BMI) between 20 and 30 kg/m2 * Hemodynamic stability with or without use of positive inotropic drugs * Absence of arrhythmias and angina * Mean blood pressure (MBP) 60 ⩽ MBP ⩽ 100 mmHg * Heart rate (HR) 60 ⩽ HR ⩽ 100 bpm without respiratory distress * Respiratory rate (RR) ⩽ 20 without signs of infection Exclusion Criteria: * Previous pulmonary disease and acute lung disease * Mechanical ventilation >24 h * Left ventricular ejection fraction (LVEF) <35% or >54% * Surgical reintervention * Intraoperative death or any contraindications for the proposed measurements and/or treatment * Contraindications for the 6MWT or any proposed protocol * Orthopedic impairments * Unstable angina * HR >120 bpm at rest, and systolic blood pressure >180 mmHg or diastolic >100 mmHg. Sex : ALL Ages : - Minimum Age : 35 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT04556994

{ "NCT_ID" : "NCT04453410", "Brief_Title" : "Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric", "Official_title" : "Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric", "Conditions" : ["Surgical Intervention", "Minor"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-09-29", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-09-29", "Study_Completion_Date(Actual)" : "2021-12-14}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2020-06-26", "First_Posted(Estimated)" : 2020-07-01" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2020-06-26", "Last_Update_Posted(Estimated)" : 2023-08-22", "Last_Verified" : 2023-08" } }}

#Study Description Brief Summary Consideration from the patient's point of view is an important step in improving postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a psychometrically validated questionnaire to measure the quality of postoperative functional recovery. it has been recommended in perioperative medecine however, this questionnaire was never adapted and validated for a pediatric surgical population. The main objective of this protocol is to study the validity, reliability, acceptability and feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15 score. #Intervention - OTHER : Questionnaire Quality-of-recovery 15 (QoR-15) - Children will use the questionnaire Quality-of-recovery 15 (QoR-15)

#Eligibility Criteria: Inclusion Criteria: * Patient underage > 7 years and up to 17 years and 9 months * Programming surgery as part of routine management * Patient affiliated with a health insurance social * Parental authority holders and the patient agreeing to participate in the study Exclusion Criteria: * Patients with severe sensory impairment in preoperation preventing reliable participation in the questionnaire * Patients at risk of severe cognitive or sensory impairment in postoperative * Patients with language difficulties in the language of administration of the questionnaire * Patients who can not express their non-opposition to participation in the study * Refusal of holders of parental authority and/or refusal of the patient to participate in the study Sex : ALL Ages : - Minimum Age : 7 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT04453410

{ "NCT_ID" : "NCT01888744", "Brief_Title" : "Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist", "Official_title" : "The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial", "Conditions" : ["Reproductive Endocrinology", "Fertility", "Optimal Stimulation Protocol"], "Interventions" : ["Drug: GnRH agonist", "Drug: Progesterone", "Drug: GnRH antagonist", "Drug: Human chorionic gonadotropin", "Drug: hP-hMG"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2010-09", "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" : 2013-06-21", "First_Posted(Estimated)" : 2013-06-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2013-06-27", "Last_Update_Posted(Estimated)" : 2013-06-28", "Last_Verified" : 2013-06" } }}

#Study Description Brief Summary The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®). Detailed Description Patients will be randomized at the outpatient clinic in two groups. #Intervention - DRUG : GnRH agonist - Other Names : - Suprefact nasal spray - DRUG : GnRH antagonist - Other Names : - Orgalutran or Cetrotide - DRUG : hP-hMG - Other Names : - Menopur - DRUG : Human chorionic gonadotropin - induction of final oocyte maturation - Other Names : - Pregnyl - DRUG : Progesterone - Other Names : - Utrogestan vaginal tablets

#Eligibility Criteria: Inclusion Criteria: * <= 39 years the day of oocyte retrieval * BMI <= 29 * cycle rank 1 * menstrual cycle 25 <= age <= 36 days * PGD or preimplantation genetic screening (PGS) requested * ICSI * Single embryo transfer (SET) on day 5 Exclusion Criteria: * Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria) * Hormonal disturbances * Endometriosis grade III and IV Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 39 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT01888744

{ "NCT_ID" : "NCT03211949", "Brief_Title" : "Ultrasound Guided Topographic Mapping of Medial Antebrachial Cutaneous Nerve", "Official_title" : "Topographic Assessment of the Medial Antebrachial Cutaneous Nerve Variations at the Axilla and Above the Cubital Fossa Using Ultrasonography", "Conditions" : ["Nerve Block", "Surgery", "Anesthesia", "Brachial Plexus Block"], "Interventions" : ["Procedure: axillary block", "Drug: Scandicaine"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2014-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12", "Study_Completion_Date(Actual)" : "2020-01-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-10-30", "First_Posted(Estimated)" : 2017-07-11" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-07-05", "Last_Update_Posted(Estimated)" : 2022-08-05", "Last_Verified" : 2022-08" } }}

#Study Description Brief Summary Blocking the medial antebrachial cutaneous nerve (MACN) during an axillary block often a subcutaneous wheal of local anesthetics is made what is described as painful. With the improvement of the resolution of the ultrasound machines smaller structures and nerves can be visable. In this study topographic assessment will made of the anatomical variation of the medial antebrachial cutaneous nerve (MACN) by ultrasound in the axilla and 5 cm above the cubital fossa of the arm. Detailed Description The ethics committee will approved the study and informed consent is obtained. Patients with contraindications for regional anaesthesia will be excluded from the study. 150 patients will be included The arm is placed above and beside the head for scanning (abduction 90 degrees at the shoulder and 90 degrees flexion at the elbow with external rotation) Ultrasound is performed with a 12-18 MHz (Mega-Herz) linear probe (BK medical). The frequency is set to 18 MHz and the depth to 3 cm and adjusted to 1 cm below the brachial artery . The terminal nerves of the brachial plexus (median, ulnar,radial an d musculocutaneous) are identified at the axillary fossa in a routine fashion described by Ranganath (see references). After identifying the MACN at the axilla and 5 cm above the cubital fossa, the images at these two sites will be stored after digital marking of the MACN, the medial and ulnar nerve and the and radial nerve on the frozen ultrasound image. Its position relative to the venous structure and the artery at the axilla will be registered in the axilla at the lower border of the conjoint tendon of the teres major and the latissimus dorsi muscle. After scanning the skin will be prepared with an aseptic solution and an axillary block will be performed with a 55 mm sonoplex 22 G short bevel ultrasound needle (Pajunk). With a partly in plane (ulnar, radial and MACN) and partly out of plane (median \& musculocutaneous nerve) technique . Mepivacaine 1.5 % will be injected around each nerve in the following order: Ulnar nerve, MACN, radial nerve, median nerve and musculocutaneous nerve. The time at which the MACN is blocked will be noted. For each nerve 5 ml of local anaesthetic solution will be injected except for the MACN nerve where 3 ml will be used because of its smaller caliber. Nerve stimulation will be used with a current of 0,2 mA (milli Amps). Following completion of the block the dermatome supplied by the MACN will be tested by loss of cold sensation. After 20 minutes the dermatomes and motor function of all nerves are tested by elbow flexion and extension, primarily thumb opposition and abduction of the index finger. Sensory block is tested at the fifth finger (ulnar nerve, the hand palm at the thumb (medial nerve)and the dorsum of the hand ( radial nerve), the lateral (musculocutaneous nerve) and medial skin ( MACN) of the forearm. Skin will be prepared with an aseptic solution and an axillary block will be performed with deposition of local anesthetic around the MACN. Data processing. The locations of the different nerves will be displayed in a pie chart with the axillary artery in the centre, as well as the relative position to the basilic vein. Statistics will only be descriptive . #Intervention - PROCEDURE : axillary block - 2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block - DRUG : Scandicaine - 2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block - Other Names : - mepivacaine

#Eligibility Criteria: Inclusion Criteria: * all patients scheduled for lower arm/hand surgery Exclusion Criteria: * patient refusal 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

NCT03211949

{ "NCT_ID" : "NCT00422890", "Brief_Title" : "Treatment of Imminent Haematological Relapse in Patients With AML and MDS Following Allogeneic Stem Cell Transplantation With 5-azacitidine (Vidaza®)", "Conditions" : ["Myeloid Leukemia", "Myelodysplastic Syndrome"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-01", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-12", }, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-01-15", "First_Posted(Estimated)" : 2007-01-17" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2007-01-16", "Last_Update_Posted(Estimated)" : 2011-07-11", "Last_Verified" : 2011-07" } }}

#Study Description Brief Summary Efficacy and safety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation. #Intervention - DRUG : 5-Azacytidin - in case of decreasing CD34 chimerism

#Eligibility Criteria: Inclusion Criteria: Screening phase: * Age > 18 years * Patients with CD34+ AML or MDS post-allogeneic HSCT * Written patient consent after consultation Treatment phase * AML/MDS: donor chimerism < 80% in the CD34+ subpopulation following allogeneic HSCT in patients with CD34+ AML or MDS, but with no haematological relapse (blasts < 5% in bone marrow) * Leukocytes > 3 Gpt/l and platelets > 75 Gpt/l (transfusion-independent) Exclusion Criteria: * Known intolerance to 5-azacitidine or mannitol * Uncontrollable infectious disease * Patients with active hepatitis B or C or HIV infection * Severe hepatic function impairment (ASAT and ALAT may not be above three times the normal value) or hepatic cirrhosis, or malignant hepatic tumour * Renal function impairment (creatinine > twice the normal value, creatinine clearance < 50 ml/min) * Pregnancy or lactation * Women of childbearing age, except for those who meet the following criteria: * postmenopausal (12 months natural amenorrhoea) * postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy) * regular and correct use of a contraceptive method with an error rate < 1% per year (e.g. implants, depot injections, combined oral contraceptives, intrauterine device - IUD, whereby hormonal coils with a Pearl Index of < 1% are safer than copper coils) * sexual abstinence * Partner vasectomy * Men who do not use one of the following for contraception: * sexual abstinence * post vasectomy * condoms * Participation of the patient in a drug trial outside the indication of allogeneic transplantation up to four weeks before study initiation * Addictive or other illnesses that prevent the person concerned from comprehending the nature and impact, as well as potentical consequences of the clinical trial * Evidence that the patient may intentionally not comply with the protocol, e.g. lack of cooperation With the exception of a known allergic reaction or intolerance to 5-azacitidine, these criteria do not apply to the screening phase. 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

NCT00422890

{ "NCT_ID" : "NCT00744211", "Brief_Title" : "Proteolytic Enzyme Induction Within the Human Myocardial Interstitium", "Official_title" : "Proteolytic Enzyme Induction Within the Human Myocardial Interstitium", "Conditions" : ["Heart Disease"], "Interventions" : ["Drug: 2mg/kg sitaxsentan sodium", "Other: Vehicle", "Drug: 1mg/kg sitaxsentan sodium"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2008-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-06", "Study_Completion_Date(Actual)" : "2013-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2008-08-27", "First_Submitted_that_Met_QC_Criteria" : 2017-11-07", "First_Posted(Estimated)" : 2008-08-29" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-08-28", "Last_Update_Posted(Estimated)" : 2017-11-09", "Last_Verified" : 2017-11" } }}

#Study Description Brief Summary A robust release of endothelin-1-1 (ET) with subsequent ETA subtype receptor (ET-AR) activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass (CPB). Increased ET-AR activation has been identified in patients with poor left ventricular (LV) function (reduced ejection fraction; EF). Accordingly, this study tested the hypothesis that a selective ET-AR antagonist (ET-ARA) administered peri-operatively would favorably affect post-CPB hemodynamic profiles in patients with a pre-existing poor LVEF. Detailed Description Patients with a reduced LVEF were prospectively randomized, in a blinded fashion, at the time of elective coronary revascularization and/or valve replacement requiring CPB, to infusion of the highly-selective and potent ET-ARA, sitaxsentan at 1 or 2 mg/kg (IV bolus) or vehicle (saline). Infusion of the ET-ARA/vehicle was performed immediately prior to separation from CPB and again at 12 hrs post-CPB. ET and hemodynamic measurements were performed at baseline, at separation from CPB (Time 0) and at 0.5, 6, 12, 24 hrs post-CPB. #Intervention - DRUG : 1mg/kg sitaxsentan sodium - 1mg/kg sitaxsentan sodium (intravenous bolus) performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass. - Other Names : - TBC11251Na - DRUG : 2mg/kg sitaxsentan sodium - 2mg/kg sitaxsentan sodium (intravenous bolus) performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass. - Other Names : - TBC11251Na - OTHER : Vehicle - Intravenous bolus performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass. - Other Names : - Saline

#Eligibility Criteria: Inclusion Criteria: * >60 years * Body mass index <40 kg/m2 * Left ventricular ejection fraction less than or equal to 50% documented by a pre-operative echocardiogram * Patients undergoing coronary artery bypass (CABG), aortic and/or mitral valve replacement or combined CABG and valve procedures requiring CPB. * If diabetic, be under proper control, (fasting glucose <350 mg/dL or recent hemoglobin A1c [HgbA1c] <9%). * If hypertensive, be on a stable medical regimen with no significant changes over the past 30 days. * Female of child bearing potential with a negative pregnancy test, or post-menopausal for at least 2 years * The patient is an appropriate study candidate as determined by the Investigator on the basis of medical history and physical examination Exclusion Criteria: * Emergent revascularization * Previous stroke or thrombo-embolic event in the 3 months prior to study entry * A previous myocardial infarction within the last 7 days * Documented coagulopathy * Hepatic dysfunction as defined by aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times the upper limit of normal * Patient is pregnant or breastfeeding Sex : ALL Ages : - Minimum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No

NCT00744211

{ "NCT_ID" : "NCT00940719", "Brief_Title" : "Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)", "Official_title" : "The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study", "Conditions" : ["Multiple Sclerosis"], "Interventions" : ["Dietary Supplement: vitamin D3"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-08", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-03", "Study_Completion_Date(Actual)" : "2010-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2009-07-15", "First_Posted(Estimated)" : 2009-07-16" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2009-07-15", "Last_Update_Posted(Estimated)" : 2010-08-11", "Last_Verified" : 2010-08" } }}

#Study Description Brief Summary In patients with Relapsing Remitting Multiple Sclerosis (RRMS), the investigators observed a positive correlation between regulatory T cell (Treg) function and vitamin D status. The present goal is to assess whether Treg function improves on supplementation with vitamin D3. Detailed Description In several studies, Multiple Sclerosis (MS) incidence and disease activity has been related with vitamin D status. We observed that RRMS patients who remained relapse free before blood collection had a better vitamin D status than patients who experienced relapses (Smolders et al. Mult Scler 2008;17:1220-1224). Since vitamin D3 is a potent promotor of T cell regulation in vitro (Smolders et al. J Neuroimmunol 2008;194:7-17), we hypothesised that a promotion of Treg function in MS patients might underlie its association with MS disease activity. In a cohort of RRMS patients, we observed a positive correlation of Treg function with vitamin D status (Smolders et al. PLoS ONE 2009;4:e6635). Furthermore, vitamin D status correlated positively with a Th1/Th2-balance which was more directed towards Th2. In the present study, we will assess whether treatment of RRMS patients with vitamin D3 promotes T cell regulation. In the present study, RRMS patients will be supplemented with vitamin D3, and regulatory T cell tests will be performed before and after supplementation. #Intervention - DIETARY_SUPPLEMENT : vitamin D3 - Oil-based solution, 1 dose of 500 microgram each day, during 3 months. - Other Names : - Vigantol Oil (Merck)

#Eligibility Criteria: Inclusion Criteria: * Relapsing Remitting MS (Revised MCDonald criteria 2005) * Age > 18 years Exclusion Criteria: * Progressive MS phenotype * Abnormalities of vitamin D hormonal system other than low dietary intake or limited sun exposure * Intake of drugs that influence vitamin D homeostasis other than corticosteroids * Conditions with in increased susceptibility to hypercalcemia * Alcohol or drug abuse * Pregnancy or the intention to become pregnant within the study 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: No

NCT00940719

{ "NCT_ID" : "NCT01347983", "Brief_Title" : "Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients", "Official_title" : "Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients", "Conditions" : ["Rheumatoid Arthritis"], "Location_Countries" : ["Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2011-05", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-03", "Study_Completion_Date(Actual)" : "2013-04}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2011-05-03", "First_Posted(Estimated)" : 2011-05-05" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2011-05-04", "Last_Update_Posted(Estimated)" : 2013-04-04", "Last_Verified" : 2013-04" } }}

#Study Description Brief Summary 24 week open-labeled extension study to continue monitoring the same group of patients in the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of tocilizumab. #Intervention - DRUG : Tocilizumab+Methotrexate(MTX) - Tocilizumab: 8 mg/kg every 4 weeks, IV infusion Methotrexate: 10-20 mg/week

#Eligibility Criteria: Inclusion Criteria: * Patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab Phase IIIb study(MRA230TW). * Patients assigned in the Phase IIIb study(MRA230TW), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by ACR20 Exclusion Criteria: * Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment. * Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA. * Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care). * Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them. * Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand & foot fungal infections can participate. 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

NCT01347983

{ "NCT_ID" : "NCT05904249", "Brief_Title" : "Telerehabilitation in Individuals With Rotator Cuff Tear", "Official_title" : "Investigation of the Effectiveness of Telerehabilitation in Individuals With Rotator Cuff Tear", "Conditions" : ["Rotator Cuff Tears", "Physiotherapy and Rehabilitation", "Shoulder Pain", "Rotator Cuff Injuries"], "Interventions" : ["Other: Internet Based Synchronized Telerehabilitation", "Other: Face-to-Face Rehabilitation"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "DOUBLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-02-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-10", "Study_Completion_Date(Actual)" : "2023-05-05}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2022-03-02", "First_Posted(Estimated)" : 2023-06-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2023-06-06", "Last_Update_Posted(Estimated)" : 2023-06-15", "Last_Verified" : 2023-06" } }}

#Study Description Brief Summary The majority of patients presenting with shoulder pain are those with rotator cuff problems. Although telerehabilitation is a promising field in many areas, there is still limited high-quality research with strong evidence of its effectiveness for musculoskeletal problems. In this study, online rehabilitation and face-to-face rehabilitation will be compared in people with partial rotator cuff tears. Detailed Description The prevalence of shoulder pain increases with age and is mostly associated with inadequate treatment of symptoms. A large part of the patients who apply to the clinic with the complaint of shoulder pain are individuals with rotator cuff problems. Partial rotator cuff (RM) tear is defined as tears that can be seen on the superior, inferior, or both sides of the cuff. It is stated that the most critical risk factors for RM tear are age, dominant arm, and trauma. The degenerative process is generally considered normal in age-related tears and is seen in 20% of individuals over the age of 65. The Coronavirus disease (COVID-19), is still the most important global concern. People with chronic diseases have been known to delay getting healthcare services due to fear of the risk of infection following the COVID-19 pandemic. This could lead to increased morbidity and mortality due to delay and disruption in access to treatment applications needed for patient populations other than COVID-19. At this stage, one of the applications that can be effective for disturbed patient healing processes is the Telerehabilitation application, which has proven its effectiveness in previous epidemics (EBOLA, SARS, etc.), when patients are treated remotely after and after treatment. Especially during the COVID-19 pandemic, there has been an increase in the need for Internet-based remote treatment approaches, as it allows both patients and physiotherapists to advance the treatment process without the risk of infection. In the next decade, telerehabilitation options are expected to diversify and become widespread in assessing and treating many diseases with emerging technologies. Studies have shown that despite the growing number of applications of telerehabilitation worldwide, evidence for clinical effectiveness is still limited. In addition, the effectiveness of telerehabilitation for musculoskeletal problems has not been fully demonstrated due to the lack of a specific standard for telerehabilitation and the variability of the approaches used. In conclusion, although telerehabilitation is a promising field in many areas, there is still a limited amount of good-quality research with strong evidence. Therefore, this study aimed to compare the effects of internet-based telerehabilitation and face-to-face rehabilitation practices on pain, range of motion, functionality, and quality of life in patients with partial rotator cuff injury. #Intervention - OTHER : Internet Based Synchronized Telerehabilitation - Week 1 * Posterior capsule stretching * Passive range of motion * Wand exercises in supine position * Scapular adduction exercise * Ball rolling on the table (\<90°) * Coldpack (15min) Week 2 * Wand exercises while standing. * Ball roll on wall (\>90°) * Ball roll on the table (90°) * Weightless External Rotation exercises * Functional PNF movements Week 3 * Resistive scapulothoracic strengthening * Ball scrolling on the table (resistive) Week 4 * Single handed ball roll on the table (\>90°) * External rotation exercise with 0.5-1kg weight in side lying * Strengthening exercises, shoulder in 90° scapulation for 10s Week 5 * External rotation with 0.5-1 kg weight in side lying * Strengthening exercises by keeping the shoulder in 90° scapulation for 10s Week 6-8 * Dynamic hugs and push up plus * Ball throwing and catching - OTHER : Face-to-Face Rehabilitation - Week 1 * Posterior capsule stretching * Passive range of motion * Wand exercises in supine position * Scapular adduction exercise * Ball rolling on the table (\<90°) * Coldpack (15min) Week 2 * Wand exercises while standing. * Ball roll on wall (\>90°) * Ball roll on the table (90°) * Weightless External Rotation exercises * Functional PNF movements Week 3 * Resistive scapulothoracic strengthening * Ball scrolling on the table (resistive) Week 4 * Single handed ball roll on the table (\>90°) * External rotation exercise with 0.5-1kg weight in side lying * Strengthening exercises, shoulder in 90° scapulation for 10s Week 5 * External rotation with 0.5-1 kg weight in side lying * Strengthening exercises by keeping the shoulder in 90° scapulation for 10s Week 6-8 * Dynamic hugs and push up plus * Ball throwing and catching

#Eligibility Criteria: Inclusion Criteria: * Presence of bursal facial tear 1 cm below the tear degree; presence of complaints of shoulder pain lasting for a minimum of 1 and a maximum of 6 months; having been diagnosed with partial rotator cuff tear by an orthopedist who is an expert in the field; no shoulder instability; inadequate response to non-operative treatment (corticosteroid injection, anti-inflammatory drugs, rest and physiotherapy and rehabilitation); not using corticosteroid drug; being between the ages of 18 <= age <= 60; to have sufficient knowledge, skills and technological tools to access the Tele-Rehabilitation application. Exclusion Criteria: * Presence of malignancy affecting the shoulder region; disc herniations that may cause shoulder pain; individuals with inflammatory joint disease; osteoarthritis of the humeral head; history of surgery affecting the shoulder; inability of the patient to cooperate; systemic problems that cannot be controlled with medication. 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

NCT05904249

{ "NCT_ID" : "NCT05071586", "Brief_Title" : "Pediatric Teleneuromodulation", "Official_title" : "Remotely Monitored Transcranial Direct Current Stimulation in Children With Cerebral Palsy", "Conditions" : ["Cerebral Palsy (CP)"], "Interventions" : ["Device: Soterix 1x1 tDCS LTE Stimulator Device Model 1401"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2022-12-21", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-06-06", "Study_Completion_Date(Actual)" : "2023-06-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-09-13", "First_Submitted_that_Met_QC_Criteria" : 2024-04-16", "First_Posted(Estimated)" : 2021-10-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-09-27", "Last_Update_Posted(Estimated)" : 2024-05-07", "Last_Verified" : 2024-04" } }}

#Study Description Brief Summary This study will explore using remotely monitored 'active' non-invasive brain stimulation in children with cerebral palsy. Participants will receive active non-invasive brain stimulation with synchronous safety monitoring and guided instruction with laboratory staff after appropriate training. Participants will be between 8-21 years old and have a diagnosis of hemiparetic cerebral palsy with a history of a perinatal stroke or brain bleed, and can expect to be in the study for 5 days. Detailed Description Current exploratory single site open label unblinded trial, will assess the feasibility, tolerability, and safety of active tDCS in the home setting under caregiver, safety monitor and remote investigator supervision and direction. The study population will consist of 10 participants between ages 8 - 21 years and 365 days with hemiparetic cerebral palsy and a history of a brain bleed or stroke. An estimated 3.6 per 1,000 births in the United States are affected by stroke or brain bleeds which can lead to Cerebral Palsy (CP), a developmental disorder associated with motor impairment. While, the majority of rehabilitation approaches focus on behavioral repetition to improve gait and upper extremity function, these therapies can require extensive practice times and extent of recovery is variable. Thus, there is a need for novel strategies which can optimize rehabilitation outcomes for this population. Brain development during childhood is characterized by heighted neuroplastic potential stressing the importance for intervention methods that harness neuroplasticity. Accordingly, several therapies are theoretically based in mechanisms of motor learning and use-dependent plasticity. Non-invasive brain stimulation (NIBS), specifically transcranial direct current stimulation (tDCS), provides an approach for modulation of neuroplasticity that is safe, inexpensive, and portable. Furthermore, rehabilitation approaches combined with tDCS have shown promise to improve motor function recovery and quality of life after stroke in adults. Integrating the application of NIBS may allow for enhanced rehabilitation during the enhanced neuroplastic period of childhood and NIBS has demonstrated promising outcomes in increasing the rate and extent of recovery. The Pediatric Neuromodulation laboratory has shown that in children with CP the use of tDCS is safe, feasible, and successful at modifying motor performance when in combination with other physical therapy interventions. tDCS is not currently available to subjects without taking part in the study. In this study, investigators plan to administer tDCS in the remote setting during a synchronous zoom call with trained laboratory members. To ensure the device is safely used in the home setting only during designated times, in the presence of a trained safety monitor. The safety monitor will bring the device to the session, oversee the safety of its use, and take it back to the laboratory after the session is complete. This intervention has the potential to improve motor rehabilitation outcomes and can offer telehealth access, which may reduce treatment cost and improve access to limited access to clinic or hospital facilities. This study has the potential to set the foundation for larger clinical trials studies evaluating the efficacy of remote tDCS combined with rehabilitation interventions in children. Ultimately, this will contribute to a wider reach in improving quality of life across the lifespan in children with CP. On Day #1 there will be a practice stimulation montage setup assessment. Before their session, a GMFCS and pediatric cognition survey will be completed with the investigative team. All participants will be asked to view instructional videos on how to perform the procedures. Parent/child pairs will perform the assessment by walking through the steps with the guidance of the lab team member via videoconferencing. Efficiency and quality of setup data will be collected. A setup ease/comfort survey will be completed upon completion of the stimulation montage setup. Days 2-5 will consist of sham/active stimulation in the home setting under caregiver, safety monitor, and remote investigator supervision and direction. Status surveys inquiring well-being will be conducted before, during, and after stimulation as well as a Box and Blocks motor function tests. At any time the participant perceives discomfort while dosing to 1.5mA the investigators will adapt and modify the stimulation intensity. Protocol Amendment Approved 6/7/2023: addition of an optional 6 and 12 month study visit. #Intervention - DEVICE : Soterix 1x1 tDCS LTE Stimulator Device Model 1401 - Participants will receive 20 minutes of 1.5 mA (Milliampere) transcranial direct current stimulation (tDCS) via Soterix 1x1 tDCS LTE Stimulator Device Model 1401 with a bilateral M1 montage.

#Eligibility Criteria: Inclusion Criteria: * Aged between 8 years 0 days and 21 years 365 days * Children who have hemiparetic cerebral palsy with a history of perinatal brain bleed/stroke * Receptive language function to follow two-step commands * Able to give informed assent along with the informed consent of the legal guardian. If the participant is 18 <= age <= 21 (with the capacity to consent), they must be able to give informed consent. * Intentional about representing the sub-population of children with CP who experience intellectual disability (at least 2/10 participants with mild intellectual disabilities will be recruited) * >= 10 degrees of active motion at the metacarpophalangeal joint * Children who have had surgeries, which may influence motor function e.g.- tendon transfer, will be included, yet surgical history will be documented and included in any publication within a participant characteristics table. Exclusion Criteria: * Inaccessibility to internet and a working computer/laptop/device. * Implants * Neoplasm * Metabolic Disorders * Epilepsy * Seizure within two years preceding the study * Acquired Traumatic Brain Injury * Pregnancy * Indwelling metal or incompatible medical devices * Evidence of skin disease or skin abnormalities * Botulinum toxin or Phenol block within [six-months] preceding the study * Disorder of Cellular Migration and Proliferation To be eligible for the optional 6-month/12-month follow-up: * participants must have previously participated in the primary study * have access to a reliable internet connection and a functioning computer, laptop, or mobile device. * If participants become pregnant after participating in primary study, they may participate in the 6- and 12-month follow up sessions Sex : ALL Ages : - Minimum Age : 8 Years - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT05071586

{ "NCT_ID" : "NCT03290404", "Brief_Title" : "Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization", "Official_title" : "Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization", "Conditions" : ["Axillary Block"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2017-11-13", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-03-19", "Study_Completion_Date(Actual)" : "2018-03-19}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2017-09-19", "First_Posted(Estimated)" : 2017-09-21" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2017-09-20", "Last_Update_Posted(Estimated)" : 2018-04-06", "Last_Verified" : 2017-11" } }}

#Study Description Brief Summary Axillary block is the good anesthetic technique for upper limb surgery without exceeding a certain total dose injected of Local Anesthetic (AL). The maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL concentration, thus decreasing the risks. No previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper limb surgery by axillary block. The literature overestimating probably the rate of failure of the locoregional anesthesia under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in standard practice.

#Eligibility Criteria: Inclusion Criteria: * Patients operated for the upper limb under block axillaire * Adult * non-opposition Exclusion Criteria: * medical advice to realize axillary block * medical advice to local anaesthetic * Allergy * Pregnant * ASA 3 or more 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

NCT03290404

{ "NCT_ID" : "NCT04847765", "Brief_Title" : "ANTERO-6 Cine-MRI Study", "Official_title" : "A Pilot Study to Assess the Procedural Feasibility to Combine and Compare Dynamic Magnetic Resonance Imaging and an Isovolumetric Intragastric Balloon to Assess Gastric Contractility in Healthy Adults", "Conditions" : ["Health"], "Interventions" : ["Device: VIPUN Gastric Monitoring System prototype"], "Location_Countries" : ["Belgium"], "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)" : "2021-04-21", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-04-30", "Study_Completion_Date(Actual)" : "2021-04-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2021-04-09", "First_Posted(Estimated)" : 2021-04-19" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2021-04-15", "Last_Update_Posted(Estimated)" : 2021-09-30", "Last_Verified" : 2021-09" } }}

#Study Description Brief Summary Previous research by TARGID (KU Leuven) has demonstrated the feasibility to assess gastric content volume by means of magnetic resonance imaging (MRI) while simultaneously evaluating gastric motor function by means of an isovolumetric balloon technique. This and other research concluded that in general, the motility readout of the isovolumetric balloon is associated with gastric contractions. However, the exact relation between individual gastric contractions and individual intraballoon pressure waves remains incompletely understood. Simultaneous assessment of gastric motility by means of an isovolumetric balloon and dynamic cine-MRI can validate that slow, high-amplitude intraballoon pressure waves are indeed induced by gastric muscle contractions. This evaluation might also enable us to attribute artefacts present in the pressure signal to physiologic processes such as cardiac, respiratory, intestinal and whole-body movements. To date substantial uncertainty exists on the optimal procedural approach to evaluate gastric motility simultaneously with cine-MRI and the isovolumetric balloon. The aim of this pilot study is to verify the feasibility of a several aspects of a larger confirmatory study protocol. This includes the evaluation of contrast of the balloon catheter on MRI (this would omit the need for radiographic confirmation), timelines, practical hurdles, analysis procedures and data management. #Intervention - DEVICE : VIPUN Gastric Monitoring System prototype - The VIPUN Balloon Catheter prototype is a nasogastric feeding tube with integrated balloon that can be inflated with a preset volume of air. Intraballoon pressure changes are recorded outside the body. Gastric contractions can be detected in the pressure profile. The recording lasts 30 minutes and is combined with simultaneous cine magnetic resonance imaging.

#Eligibility Criteria: Inclusion Criteria: * Signed Informed Consent * At least 18 years * Male * BMI between and including 18 and 30 * Understand and able to read Dutch * In good health on the basis of medical history Exclusion Criteria: * Using any medication that might affect gastric function or visceral sensitivity * Known / suspected current use of illicit drugs * Known psychiatric or neurological illness * Any gastrointestinal surgery that could influence normal gastric function in the opinion of the Investigator * History of heart or vascular diseases like irregular heartbeats, angina or heart attack * Nasopharyngeal surgery in the last 30 days * History of thermal or chemical injury to upper respiratory tract or esophagus * Current esophageal or nasopharyngeal obstruction * Known coagulopathy * Known esophageal varices * Metal or other MRI incompatible implants * Contra-indications for MR (checked by MR safety questionnaire) * Claustrophobia Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT04847765

{ "NCT_ID" : "NCT01158742", "Brief_Title" : "Live Kidney Donor Study -Renal Function Study", "Official_title" : "Live Kidney Donor Study -Renal Function Study", "Conditions" : ["Kidney Donation", "Kidney Failure", "Kidney Transplantation"], "Interventions" : ["Other: Glomerular Filtration Rate with Iothalamate", "Other: Glomerular Filtration Rate with Iohexol"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2009-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-06", "Study_Completion_Date(Actual)" : "2012-06}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2010-07-07", "First_Posted(Estimated)" : 2010-07-08" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2010-07-07", "Last_Update_Posted(Estimated)" : 2017-03-27", "Last_Verified" : 2017-03" } }}

#Study Description Brief Summary Kidney transplantation from living donors has been shown to carry many benefits over deceased donor transplantation. Because of benefits such as shorter waiting times and improved outcome for transplant recipients, living kidney donation accounts for an increasing number of kidney transplants nationwide. Most published studies about living kidney donation demonstrate that the procedure is safe, but they also emphasize concerns that long-term data on live donor outcomes are insufficient. In particular, data concerning the extent of renal function decline after donation are inadequate. This study will measure glomerular filtration rate (GFR) in previous living donors and aims to more accurately describe renal function after kidney donation. Detailed Description Previous studies poorly describe renal function after kidney donation. Most published studies of renal function after donation are based on predictive equations, which were not designed for living kidney donors. One concern is that use of these equations may underestimate glomerular filtration rate (GFR) following donation. Systematic underestimation of GFR may cause previous kidney donors to be inaccurately categorized as having chronic kidney disease (CKD). While data for the entire kidney donor population are insufficient, there is even less available information about renal function after donation in black renal donors. In the general population, the incidence of end stage renal disease is higher among blacks compared to whites. Whether this pattern carries over to the black renal donor population is unclear. The primary objectives of this study are to more accurately measure current GFR; evaluate the change in GFR before and after donation; compare measured GFR in donors matched by race, age, sex, time from donation, presence of hypertension, and presence of obesity; and evaluate differences between predictive equations and measured GFR. This is an observational study to look at the long term outcomes in living kidney donors. Participants in this study will also be participants in DAIT RELIVE-04. As a part of this study, participants will have a brief medical history taken and a glomerular filtration rate test performed. #Intervention - OTHER : Glomerular Filtration Rate with Iothalamate - used to determine kidney function - Other Names : - GFR - OTHER : Glomerular Filtration Rate with Iohexol - used to determine kidney function - Other Names : - GFR

#Eligibility Criteria: Inclusion Criteria: * Underwent unilateral donor nephrectomy between 5 and 50 years ago; but no later than June 30, 2005 at Mayo Clinic or University of Minnesota * Alive at the time of study recruitment * Underwent GFR measurement before and early after donor nephrectomy (Mayo Clinic participants only) * Underwent GFR measurement late after donor nephrectomy and 3 or more years prior to the invitation to participate in this study (UMN participants only) * Self reported black race (UAB participants only) * Negative serum pregnancy test (Total Beta Human Chorionic Gonadotropin (HCG) <5) for women of child-bearing potential Exclusion Criteria: * Less than 5 years out from time of kidney donation * Inability to contact donor * Inability or unwillingness to provide informed consent * Iodine or iodinated contrast allergy. * Pregnant or breast feeding women Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No

NCT01158742

{ "NCT_ID" : "NCT03414372", "Brief_Title" : "Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)", "Official_title" : "Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men", "Conditions" : ["Hiv", "HIV/AIDS", "Disclosure"], "Interventions" : ["Behavioral: Standard of Care", "Behavioral: Tough Talks Clinic", "Behavioral: Tough Talks Online"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "SINGLE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2019-05-07", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-04-07", "Study_Completion_Date(Actual)" : "2022-04-07}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2018-01-22", "First_Submitted_that_Met_QC_Criteria" : 2023-02-03", "First_Posted(Estimated)" : 2018-01-29" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2018-01-22", "Last_Update_Posted(Estimated)" : 2023-03-06", "Last_Verified" : 2023-02" } }}

#Study Description Brief Summary Tough Talks is a virtual reality based HIV disclosure intervention that allows HIV+ individuals to practice disclosing to romantic partners. Tough Talks allows participants to have the opportunity to practice disclosing using a variety of strategies and experience different outcomes including acceptance, confusion, lack of HIV knowledge, and rejection. Detailed Description During Phase I of this project, the investigators developed an iPad based virtual reality system that features three avatars, two virtual locations and three disclosure scenarios which represent a variety of common disclosure experiences and contexts experienced by YMSM. In Phase II the investigators will further enhance Tough Talks and develop a full-feature automated version to test via a multi-site, randomized controlled trial (RCT) through the newly created Center for Innovative Technologies (iTech) across the Prevention and Care Continuum, an NIH-funded center to support adolescent HIV research. #Intervention - BEHAVIORAL : Tough Talks Online - Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals. - Other Names : - Tough Talks - BEHAVIORAL : Tough Talks Clinic - Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic. - BEHAVIORAL : Standard of Care - Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.

#Eligibility Criteria: Inclusion Criteria: * 16 <= age <= 29 years * assigned male at birth * male identified * HIV infected * Owns a mobile device or has access to a laptop or desktop computer * able to understand, read, and speak English * Reports 1 or more episodes of anal intercourse with a male partner in the last 6 months Exclusion Criteria: * HIV negative * assigned female at birth * 15 or younger * >= 30 years Sex : MALE Ages : - Minimum Age : 16 Years - Maximum Age : 29 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT03414372

{ "NCT_ID" : "NCT00053573", "Brief_Title" : "rhGAA in Patients With Infantile-onset Glycogen Storage Disease-II (Pompe Disease)", "Official_title" : "An Open-Label, Multicenter, Multinational, Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of rhGAA Treatment in Patients Greater Than 6 Months and Less Than or Equal to 36 Months Old With Infantile-Onset GSD-II", "Conditions" : ["Glycogen Storage Disease Type II", "Pompe Disease", "Acid Maltase Deficiency Disease", "Glycogenosis 2"], "Interventions" : ["Biological: Myozyme"], "Location_Countries" : ["France", "Israel", "United Kingdom", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2003-02", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-07", "Study_Completion_Date(Actual)" : "2006-11}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2003-01-31", "First_Posted(Estimated)" : 2003-02-03" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2003-02-01", "Last_Update_Posted(Estimated)" : 2014-02-05", "Last_Verified" : 2014-02" } }}

#Study Description Brief Summary Glycogen Storage Disease Type II ('GSD-II'; also known as Pompe disease) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with GSD-II, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. This study is being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme replacement therapy for GSD-II. Patients diagnosed with infantile-onset GSD-II who are greater than 6 months old, but less than or equal to 36 months old will be studied. #Intervention - BIOLOGICAL : Myozyme - 20 mg/kg to 40 mg/kg qow - Other Names : - Alglucosidase alfa

#Eligibility Criteria: Inclusion Criteria: * The patient or the patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed * The patient must have a clinical diagnosis of infantile GSD-II as defined by: (a) the patient has/had documented (in a medical record) onset of symptoms compatible with GSD-II by 12 months of age; (b) the patient has documented GAA deficiency as illustrated by an endogenous GAA activity less than or equal to 2% of the mean of the normal range as assessed in cultured skin fibroblasts; AND (c) the patient has a Left Ventricular Mass Index greater than 2 standard deviations above the mean for age * The patient is greater than 6 months old and less than or equal to 36 months old at the time of the first dose of rhGAA * The patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol Exclusion Criteria: * Signs and symptoms of cardiac failure and an ejection fraction less than 40% * Major congenital abnormality * Clinically significant organic disease (with the exception of symptoms relating to GSD-II), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial or potentially decrease survival * Use of any investigational product within 30 days prior to study enrollment * Received enzyme replacement therapy with GAA from any source Sex : ALL Ages : - Minimum Age : 6 Months - Maximum Age : 36 Months - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No

NCT00053573

{ "NCT_ID" : "NCT00602953", "Brief_Title" : "Role of Pancreatic Triglyceride Content in Beta-cell Function", "Official_title" : "Role of Pancreatic Triglyceride Content in Beta-cell Function", "Conditions" : ["Obesity", "Type 2 Diabetes"], "Interventions" : ["Other: No intervention planned."], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2007-09", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-08", "Study_Completion_Date(Actual)" : "2012-08}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2007-10-25", "First_Submitted_that_Met_QC_Criteria" : 2017-11-29", "First_Posted(Estimated)" : 2008-01-28" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2008-01-15", "Last_Update_Posted(Estimated)" : 2017-12-26", "Last_Verified" : 2017-11" } }}

#Study Description Brief Summary The study evaluates if fat accumulates in the pancreas in individuals at risk of developing obesity-related diabetes. It also evaluates if the amount of fat in the pancreas can predict the residual functional capacity of the pancreas (insulin secretion). #Intervention - OTHER : No intervention planned. - This is a cross-sectional observational study, no intervention is planned.

#Eligibility Criteria: Inclusion Criteria: * adults without prior history of pancreatic disease (other than diabetes) Exclusion Criteria: * use of unapproved medications * contraindications to the MRI procedure * contraindications to frequent blood draws * pregnancy * use of more than 2 alcoholic drinks/day Sex : ALL Ages : - Minimum Age : 21 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes

NCT00602953

{ "NCT_ID" : "NCT02139332", "Brief_Title" : "A Primary Prevention Trial to Strengthen Child Attachment in a Native Community", "Official_title" : "A Primary Prevention Trial to Strengthen Child Attachment in a Native Community", "Conditions" : ["Parent-child Interaction"], "Interventions" : ["Behavioral: Resource & Referral Group", "Behavioral: PFR Group"], "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)" : "2015-06", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03", "Study_Completion_Date(Actual)" : "2021-06-30}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2014-05-13", "First_Posted(Estimated)" : 2014-05-15" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2014-05-13", "Last_Update_Posted(Estimated)" : 2021-09-02", "Last_Verified" : 2021-08" } }}

#Study Description Brief Summary The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Health Promotion program, and to assess the efficacy of the method in this community. #Intervention - BEHAVIORAL : PFR Group - The intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session begins with a brief discussion and education on the target topic for that week . Then 20 minutes is spent on video recording a structured interaction between the caregiver and child or viewing the previous session's recording and engaging in reflective discussion about successful caregiving strategies and child's response to caregiver behavior (alternating weeks). Trained PFR specialists who are community members use the 5 'consultation strategies,' labeled Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts. - BEHAVIORAL : Resource & Referral Group - The Resource \& Referral program consists of 1) an initial needs assessment to determine if the enrolled family has any unmet needs (housing, financial, health, mental health, etc...), 2) a tailored resource and referral packet will be mailed to the participant with the most important referrals marked, 3) a follow-up call will be made two weeks after mailing the packet to verify that the participant has received it, and 4) a second follow-up call will be made three months after the initial session, to assess types of services actually received, barriers to receiving services, and reassessing resources needed and providing additional referrals if needed.

#Eligibility Criteria: Inclusion Criteria: * Primary caregiver for a child aged 10 to 30 months * Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months. * Child is an American Indian or Alaska Native living on or near the Tribe's reservation. * Caregiver has telephone access * Caregiver is willing to have researchers come to their house * Caregiver is English speaking * Caregiver is willing to participate in a home-visiting program which includes video-recorded sessions of caregivers and their children playing Exclusion Criteria: Caregiver is * Hospitalized or imprisoned * Living in a Treatment facility or shelter * Unable to give consent * Live in a household that already has a dyad enrolled in the study. Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT02139332

{ "NCT_ID" : "NCT02841241", "Brief_Title" : "Esmolol Infusion for Patients With Septic Shock and Persistent Tachycardia", "Official_title" : "Esmolol to Control Adrenergic Storm in Septic Shock - Roll-in", "Conditions" : ["Septic Shock"], "Interventions" : ["Drug: Esmolol"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional_Model" : "SINGLE_GROUP", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2016-04", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-03", "Study_Completion_Date(Actual)" : "2017-03}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2016-07-14", "First_Submitted_that_Met_QC_Criteria" : 2018-12-20", "First_Posted(Estimated)" : 2016-07-22" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2016-07-19", "Last_Update_Posted(Estimated)" : 2019-01-09", "Last_Verified" : 2018-12" } }}

#Study Description Brief Summary This is a prospective, single arm, 'roll-in' study of esmolol infusion for patients with septic shock with persistent tachycardia after adequate intravenous volume expansion. The study will evaluate the adequacy and efficiency of study protocols for the anticipated, main ECASSS study, which will have a separate entry in clinicaltrials.gov. Detailed Description PRIMARY OBJECTIVE: To evaluate the adequacy and efficiency of study protocols for the anticipated, randomized, controlled ECASSS study. The primary clinical outcome is organ-failure free days at 28 days, with multiple secondary outcomes, including those relevant to function of and compliance with the study protocols. #Intervention - DRUG : Esmolol - Esmolol infusion - Other Names : - Brevibloc

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * Within 48 hours of admission to the ICU and septic shock (sepsis present at time of admission) a. Septic shock defined by consensus criteria as i. At least two systemic inflammatory response syndrome (SIRS) criteria ii. Suspected or documented infection iii. Receiving vasopressors to treat hypotension after at least 20 ml/kg intravenous crystalloid volume expansion * Receiving vasopressors through a central venous catheter for more than 60 minutes. * Arterial catheter in place or expected to be placed imminently. * Heart rate > 90/min while receiving vasopressors for more than 60 minutes. * Adequately volume expanded, as manifest by any of the following, performed as part of routine clinical care (i.e., no study procedures will be performed before signed consent). If none of these measures are clinically available, the clinical attending must confirm that volume expansion is adequate. (After enrollment, a final safety check will confirm the adequacy of volume expansion.) 1. Central venous pressure (CVP) > 15 mm Hg. 2. Negative Passive-Leg Raise (PLR) maneuver (<10% increase in cardiac output after PLR). 3. No cardiac output response (<10% increase) after rapid infusion (<5 min) of 250 ml of IV crystalloid, i.e., a graded volume expansion challenge (GVEC). 4. For patients who happen to be breathing passively on a positive pressure mechanical ventilator delivering at least 8 ml/kg tidal volumes and in normal sinus rhythm, stroke volume variability <10% (such patients are acknowledged to be uncommon; the protocol does not recommend or require the induction of passive breathing). Exclusion Criteria: * Lack of informed consent. * Currently receiving ECMO (extracorporeal membrane oxygenation). * Known pregnancy or nursing. * Patient is a prisoner. * Patient on hospice (or equivalent comfort care approach) at or before the time of enrollment. * Known or current atrial fibrillation. * Previously enrolled in the trial. * Known allergy to esmolol or vehicle * Receipt of nodal blocking agents within three half lives * Hemoglobin < 7 gm/dl. * Cardiac arrest within 24 hours. * Pulmonary hypertension (moderate or severe), from documented history of prior right heart catheterization or current evidence on TTE (transthoracic echocardiography) of any of the following * mPAP (mean pulmonary artery pressure) >= 35 mmHg * SPAP (systolic pulmonary artery pressure)>= 60 mmHg * Cardiovascular collapse, as manifested by inability to achieve a MAP (mean arterial pressure) of 65 mmHg with vasopressor therapy. * Cardiogenic shock, as defined by any of the following * Cardiac index <= 2 L/min/m2 * Ejection fraction <= 25% * ScvO2 <= 60% * Current infusion of any dose of dobutamine, milrinone, or dopamine * Current infusion of epinephrine for clinically diagnosed cardiogenic shock * Significant atrioventricular dysfunction * Sick sinus syndrome * PR interval (time from onset of P wave to start of QRS complex) > 200 msec * Current evidence or prior history of Grade 2 or Grade 3 heart block * Pacemaker or plans to place a pacemaker * Pheochromocytoma or status asthmaticus * Receiving clonidine, guanfacine, or moxonidine * Hemoglobin < 7 gm/dl * Cardiovascular collapse (failure to achieve MAP of 65mmHg) * Cardiac arrest within 24 hours * Worse than moderate aortic stenosis * Known aortic stenosis, with any of (1) mean gradient >= 40 mmHg OR (2) maximum gradient >= 60mmHg OR (3) aortic valve area <= 1.0cm2 OR (4) aortic valve area index <= 0.85cm2/m2 body surface area. * Worse than mild mitral stenosis * Known mitral stenosis, with any of (1) valve area <= 1.5 cm2 OR mean gradient >= 5 mmHg. 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

NCT02841241

{ "NCT_ID" : "NCT04198584", "Brief_Title" : "Study of Telemedicine Stress Management and Lifestyle Group Intervention for HCV Patients", "Official_title" : "Pilot Feasibility Testing of a Small Randomized Controlled Trial to Evaluate a Telemedicine Stress Management and Lifestyle Group Intervention for Patients With Symptomatic Chronic Hepatitis C", "Conditions" : ["Chronic Hepatitis C"], "Interventions" : ["Behavioral: VC-CBCS"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional_Model" : "PARALLEL", "Masking" : "NONE" }, "Recruitment_Information" : { "Study_Start_Date(Actual)" : "2020-04-10", "Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-01-12", "Study_Completion_Date(Actual)" : "2021-02-24}, "Study_Record_Dates" : { ""Study_Registration_Dates" : { "First_Submitted" : 2019-12-09", "First_Submitted_that_Met_QC_Criteria" : 2022-01-06", "First_Posted(Estimated)" : 2019-12-13" }, "Study_Record_Updates" : { "Last_Updated_that_Met_QC_Criteria" : 2019-12-11", "Last_Update_Posted(Estimated)" : 2022-10-24", "Last_Verified" : 2021-05" } }}

#Study Description Brief Summary A pilot feasibility study of a small randomized controlled trial (RCT) comparing a video-conferencing cognitive behavioral coping skills (VC-CBCS) group to standard of care (SC) for symptomatic patients previously diagnosed with chronic hepatitis C to evaluate feasibility, patient satisfaction and differences in symptoms, quality of life and liver markers. Detailed Description This is a pilot feasibility study of a small randomized controlled trial (RCT) to evaluate a cognitive behavioral coping skills (CBCS) delivered via videoconferencing, referred to as the 'VC-CBCS' compared to standard of care (SC). The study included a representative sample of 32 symptomatic patients who have/had chronic hepatitis C. Patients (n=32) were randomized in a 1:3 ratio to (1) standard of care (SC) or (2) to participate in 14, two hour VC-CBCS sessions. Four groups of patients were randomized and consisted of 7-9 patients each. The groups were as follows: * Group 1: 7 patients with 5 randomized to VC-CBCS and 2 to SC; * Group 2: 9 patients with 7 randomized to VC-CBCS and 2 to SC; * Groups 3 and 4: 8 patients each with 6 randomized to VC-CBCS and 2 to SC each group. Each wave of VC-CBCS patients formed a group to join the Group Facilitator via a WebEx platform on a weekly basis using iPads from their homes. The telehealth intervention provided group-based education, skills and practices involving stress management, coping with symptoms, and support for healthy lifestyle changes. The researchers examined: (1) the feasibility of delivering a group intervention via telehealth technology remotely using iPads, (2) participant satisfaction with the intervention, and (3) whether differences are observed in several outcomes between the two conditions on quality of life, physical and mental symptoms, and liver markers. Participants completed patient-reported outcome (PRO) surveys at four time points during the study, with main outcomes being change from pre-intervention to post-intervention. #Intervention - BEHAVIORAL : VC-CBCS - A 14-module stress management and lifestyle group-based intervention delivered via videoconferencing WebEx technology to participants who have/had chronic hepatitis C and experience symptoms, stress or lifestyle requirements to promote liver health.

#Eligibility Criteria: Inclusion Criteria: * Age 21 and older; * Medically cleared by hepatology * Patients who are currently or were previously diagnosed with chronic Hepatitis C Viral (HCV) infection; * Evidence of ongoing symptoms, stress, or unhealthy lifestyle habits, defined as a score of greater than or equal to 4 on a scale 0(none) - 10 (severe) on two or more numeric rating scale questions (see Screening Form 1); * Able to read and speak English. Exclusion Criteria: * Decompensated liver disease (Childs Pugh C) judged by hepatologist or recorded in patient medical record; * Life expectancy of <12 months estimated by hepatologist; * Has had a liver transplant or is on the wait list for a transplant * Severe alcohol or substance use disorder, psychiatric disorder or cognitive impairment that is likely to interfere with the ability to participate in telehealth groups and follow guidelines about group participation as judged by the Hepatology provider or research staff; * Lack of private, quiet space in home in which to participate in VC-CBCS sessions * Unwilling to have intervention sessions audio-recorded 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

NCT04198584