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Набира участници Фаза 4

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Gestational Diabetes

This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, the investigators will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps the participants' pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, the investigators hope to find out if exenatide might also be helpful in gestational diabetes.

Начало: 12.04.2023 Край: 31.12.2026 Възраст: 18–50 г.

United States Maisa N. Feghali, MD NCT05482789

Набира участници Фаза 2

Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue.

Stroke Stroke, Chronic Fatigue

This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for post-stroke fatigue in people who have had a stroke more than six months prior to enrolling. Fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. Magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. Participants in this trial will receive a type of magnetic stimulation called repetitive transcranial magnetic stimulation, or rTMS. The investigators will measure feelings of fatigue and other clinical characteristics related to mood and cognition before and after participants receive rTMS.

Начало: 10.04.2023 Край: 29.10.2027 Възраст: 34–80 г.

United States VA Office of Research and Development NCT05584124

Набира участници Фаза 2

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Advanced Malignant Solid Neoplasm Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Locally Advanced Malignant Solid Neoplasm +11

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.

Начало: 07.04.2023 Край: 01.07.2030

Puerto Rico, United States National Cancer Institute (NCI) NCT05564377

Набира участници Фаза 2

Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant

Allogeneic Stem Cell Transplantation

Bloodstream infections (BSI) caused by bacteria translocating across injured oral mucosa are a significant cause of morbidity and mortality in patients undergoing stem cell transplantation (SCT). Unfortunately, there are currently no known strategies to prevent these BSI in this vulnerable population. The investigators will conduct a randomized, double-blind, placebo-controlled trial at three institutions to evaluate the effectiveness of twice daily intraoral xylitol-wipe application on reducing BSI in pediatric SCT patients.

Начало: 04.04.2023 Край: 30.06.2027 Възраст: 4–25 г.

United States Children's Hospital Medical Center, Cincinnati NCT05579639

Набира участници

Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach

Primary Sclerosing Cholangitis

Background: Primary sclerosing cholangitis is a rare chronic liver disease. It affects the bile ducts of the liver. It can result in bile duct infections, cirrhosis, cancer, and end stage liver disease. Researchers want to learn more about this disease. Objective: To understand the biological causes of primary sclerosing cholangitis. Eligibility: Adults age 18 and older who have primary sclerosing cholangitis. Design: Participants will be screened with a medical history, physical exam, and blood tests. Participants will give blood, saliva, urine, and stool samples. They will have nasal swabs. They will complete surveys. Participants will get an intravenous (IV) catheter. A plastic tube is inserted into an arm vein. Participants will have a colonoscopy. A tube with a video camera at the end is inserted into the rectum. Participants will have an upper endoscopy. A scope with a light and camera at its tip is used to look inside the upper digestive tract. Participants will have a liver biopsy, entering through the chest wall or a neck vein. Blood is drawn from a blood vessel that carries blood to the liver. A liver tissue sample is taken. Participants will have magnetic resonance imaging or spectroscopy. They will get a contrast agent through an IV. Participants may have an optional bone marrow aspiration. A large needle is inserted into the hip to withdraw marrow. Participants will have a liver ultrasound. Participants will complete a 3-day food diary. They will have a nutrition assessment. Participants may give contact details for people who live with them, to also take part in this study. Participation will last for 12 months.

Начало: 31.03.2023 Край: 31.10.2026 Възраст: 18–90 г.

United States National Institute of Diabetes and Digestive and Kidney NCT04685200

Набира участници

Home Apnea Testing in CHildren Trial

Sleep Apnea, Obstructive Sleep Disorder Sleep Apnea Syndromes Sleep Disturbance

This clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.

Начало: 29.03.2023 Край: 01.07.2027 Възраст: 5–12 г.

United States Children's Hospital of Philadelphia NCT05382754

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Sequent Extended Study

Coronary Artery Disease Ischemic Heart Disease

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.

Начало: 28.03.2023 Край: 01.07.2026 Възраст: от 18 г.

Spain Fundación EPIC NCT05788432

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Oropharyngeal Exercises to Treat Obstructive Sleep Apnea

Obstructive Sleep Apnea

The goal of this study is to determine whether a randomized controlled trial using oropharyngeal exercises to treat sleep apnea is feasible. Continuous positive airway pressure (CPAP) is the standard therapy for Obstructive sleep apnea (OSA), but it is poorly tolerated by many patients. Oropharyngeal exercises (OPEs) which are commonly used by speech-language pathologists to improve oro-motor strength, may serve as a promising alternative approach. The main questions this study aims to answer are: * Is it feasible to use an oropharyngeal exercise protocol in patients with sleep apnea? * Will oropharyngeal exercises improve sleep apnea severity, daytime sleepiness, sleep quality, mood, workplace performance, and quality of life Participants will be randomized into a supervised OPE intervention arm vs. unsupervised OPE intervention arm vs. sham treatment for a 10-week/5-day per week/two 20-minute session exercise protocol. The exercises will be administered via an app and the investigators will assess feasibility, as well as several sleep-related and oro-motor physiological outcomes before treatment, immediately post-treatment, and 4 weeks post-treatment. The investigators will use the results of this feasibility trial to inform the sample size needed for a larger clinical trial that will determine the efficacy of using oropharyngeal exercises to treat OSA.

Начало: 28.03.2023 Край: 01.03.2027 Възраст: от 18 г.

Canada Sunnybrook Health Sciences Centre NCT05678088

Набира участници Фаза 2

A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251

Geographic Atrophy

This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated. The substudy will evaluate the operational feasibility and scientific interpretability of incorporating AO retinal imaging using the EarlySight Cellularis® Discovery device. Participants who have fulfilled the eligibility requirements for the parent study and meet the substudy's eligibility criteria will have the option to participate in the substudy. The EarlySight Cellularis® Discovery device will be used only as an assessment tool and data obtained from this device will not be used to guide clinical care or influence clinical outcomes for participants.

Начало: 23.03.2023 Край: 01.03.2031 Възраст: от 50 г.

Israel, United States Genentech, Inc. NCT05626114

Набира участници

Childhood Cancer Survivors' Affective Response to Exercise

ALL, Childhood Acute Lymphoblastic Leukemia

The primary objective of this study is to assess the feasibility of administering the Personalized Single-Category Implicit Association Test (PSC-IAT) to young adult survivors of childhood cancer. Participants will perform a total of three trials of a cognitive task before and after their scheduled SJLIFE cardiovascular stress testing. Participants will then be asked to participate in a qualitative interview about the cognitive task tool and body sensations and emotions experienced during exercise.

Начало: 22.03.2023 Край: 01.02.2030 Възраст: 18–39 г.

United States St. Jude Children's Research Hospital NCT05763290

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Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL

Prostate Cancer Biochemically Recurrent

Background: Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer. Objective: To learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer. Eligibility: Men aged 18 and older with prostate cancer that returned after treatment. Design: Participants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis. Participants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET/CT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET/CT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes. Participants will return for blood tests every 3 months. Participants will return for additional scans with 18F-DCFPyL on this schedule: Once a year if their previous scan was negative for prostate cancer. Every 6 months if their previous scan was positive for prostate cancer. Participants may be in the study up to 5 years. ...

Начало: 21.03.2023 Край: 31.12.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT05588128

Набира участници

A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA

Growth Hormone Deficiency

The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care

Начало: 20.03.2023 Край: 01.03.2033

United States Ascendis Pharma Endocrinology Division A/S NCT05820672

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TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients

Breast Cancer Stage III Breast Cancer Breast Cancer Female Stage I Breast Cancer +1

This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.

Начало: 20.03.2023 Край: 01.02.2027 Възраст: от 65 г.

United States Dana-Farber Cancer Institute NCT05535192

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A Prospective Natural History Study of Lymphatic Anomalies

Lymphatic Diseases Lymphatic Abnormalities

Background: The lymphatic system is a network of vessels that carry a clear fluid called lymph through the body. Problems in the lymphatic system can cause pain, fluid buildup, and issues with immunity. There is much researchers do not understand about lymphatic anomalies. In this natural history study, they will collect data from a lot of people over a long time. Objective: To better understand why lymphatic anomalies develop. The goal is to improve future treatments. Eligibility: People aged 0 days and older with a suspected or confirmed lymphatic anomaly. Their unaffected parents or siblings aged 7 years or older are also needed. Design: Participants may remain in the study indefinitely. Affected participants may be evaluated every 10 months to 2 years. Some participants will be seen over telemedicine. Others will be seen at the NIH Clinical Center for 2-5 days. All participants will have a physical exam. They may provide specimens including blood, saliva, hair follicles, stool, skin, and other tissues. Samples may be used for genetic testing. Participants may undergo other tests depending on their medical conditions. The NIH Clinical Center visit may include: Heart tests include placing stickers on the chest to measure electrical activity and using sound waves to capture pictures of the heart. A lung test measures the muscle strength in the chest. Participants will blow into a tube. Photographs may be taken of participants faces and other features. Imaging scans will take pictures of the inside of the body. One scan will measure bone density. One type of scan tracks how lymph fluid moves through the body. Participants will be under anesthesia, and they will be injected with a dye.

Начало: 20.03.2023 Край: 31.12.2028 Възраст: 1–100 г.

United States Eunice Kennedy Shriver National Institute of Child Heal NCT05731141

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Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries

BRCA Mutation Ovarian Cancer Ultrasound Therapy; Complications

The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases: Model development phase (ambispective) AIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis; Implementation and validation phase (prospective) AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.

Начало: 20.03.2023 Край: 08.03.2031

Italy Fondazione Policlinico Universitario Agostino Gemelli I NCT05769517

Набира участници Фаза 2

TArgeting Type 1 Diabetes Using POLyamines (TADPOL)

Type 1 Diabetes

The goal of this clinical trial is to test a drug known as DFMO in people with Type 1 Diabetes (T1D). The main question\[s\] it aims to answer are: * Does it reduce stress on the cells that make insulin? * Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks like DFMO but has no active ingredients) two times a day for about 6 months. Participants will have 6 in person visits and 1 phone visit over a period of 12 months. Visits will include blood draws urine collection and other tests.

Начало: 14.03.2023 Край: 01.05.2028 Възраст: 4–40 г.

United States Emily K. Sims NCT05594563

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BPH Global Registry

Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

Benign prostatic hyperplasia (BPH) is one of the most common performed surgical procedures in urology. Over the past few decades there have been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been standardized. While data are available for the initial pivotal studies, post-market release data are lacking. Under the umbrella of uCARE, we have started a prospective, ongoing international registry for recording demographics and outcomes for patients undergoing surgical treatments for BPH.

Начало: 13.03.2023 Край: 01.03.2027 Възраст: от 18 г.

Canada, Chile, China +16 Société Internationale d'Urologie NCT05543200

Набира участници

Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

Postural Tachycardia Syndrome

This study is being conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. The information may help doctors to learn more about how the different parts of people's brains communicate.

Начало: 06.03.2023 Край: 01.12.2026 Възраст: 12–21 г.

United States Virginia Commonwealth University NCT05618054

Набира участници

Combating Alzheimer's Through Sleep and Exercise

Alzheimer Disease Dementia

The purpose of this research is to see how sleep and exercise affects dementia risk over time.

Начало: 01.03.2023 Край: 30.12.2028 Възраст: 45–80 г.

United States University of Miami NCT04855630

Набира участници Фаза 2

A Digital Intervention for Post-Stroke Depression and Executive Dysfunction

Executive Dysfunction Depression Stroke

Individuals with stroke commonly experience both depression and cognitive difficulties. The goal of this study is to evaluate the efficacy of a treatment that combines a digital therapeutic (an iPad-based cognitive training program) with learning cognitive strategies. The hypotheses are that this treatment will improve cognitive skills, depression symptoms, daily function, and brain connectivity. In the short-term, the findings will inform the efficacy of the intervention and in the long-term, may support the use of the intervention to improve co-occurring cognitive and mood difficulties after stroke.

Начало: 01.03.2023 Край: 30.09.2026 Възраст: 50–79 г.

United States Weill Medical College of Cornell University NCT05507138

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