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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