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Набира участници Фаза 2/3

Study of SKY-0515 for Safety, Efficacy, and Pharmacodynamics in Participants With Huntington's Disease

Huntington Disease Huntingtons Disease

The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.

Начало: 27.05.2025 Край: 01.12.2027 Възраст: от 25 г. Лечение

Australia, New Zealand Skyhawk Therapeutics, Inc. NCT06873334

Набира участници

tVNS During Motor Training in Older Adults

Older Adults

The goal of this study is to learn about the effect of applying transcutaneous vagus nerve stimulation (tVNS) during motor training on motor learning in older adults. The main question it aims to answer is whether applying tVNS after successful motor trials (post-success tVNS) will facilitate the rate of motor learning. Participants will be randomly assigned to tVNS or sham group and receive tVNS or sham, respectively, at the outer ear during finger control training sessions. Finger control performance will be tested before and after the training sessions without outer ear stimulation.

Начало: 27.05.2025 Край: 31.07.2026 Възраст: 65–84 г.

United States Georgia Institute of Technology NCT06323954

Набира участници Фаза 4

Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy

Iron-deficiency Anemia (IDA) Pregnancy

This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.

Начало: 27.05.2025 Край: 30.07.2029 Възраст: 18–45 г.

United States Southern Illinois University NCT06492512

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Investigating the Prevalence and Risk Factors for Sarcopenia Amongst Adults Seeking Treatment for Obesity

Obesity

Sarcopenia, a condition where individuals lose muscle mass and strength, is associated with poorer health and function. While aging is a well-known cause of sarcopenia, obesity is increasingly recognised as a significant factor. When sarcopenia and obesity occur together, it can result in more severe health problems. This is especially concerning because weight loss, the treatment for obesity, can further reduce muscle mass and potentially worsen the situation. Despite this, it is unknown how common sarcopenia is among people with obesity, as only a few studies have looked into this using the most accurate diagnostic criteria, showing a prevalence of 4-13%. In this study, the investigators will examine the prevalence of sarcopenia in 300 adults with obesity at a specialized Obesity Center. The investigators expect to find a higher prevalence among Asian participants due to differences in body composition compared to other ethnic groups. The investigators will also explore various factors that might be linked to sarcopenia in these individuals, such as age, gender, race, body mass index, smoking and alcohol use, medical conditions, medications, physical activity, aerobic capacity, and dietary protein intake. Some of these factors could help in identifying those at risk of sarcopenia and could be targeted for future treatments. Currently, screening for sarcopenia is not a standard part of routine obesity care as it requires specialized equipment and trained staff. By determining how common sarcopenia is in people with obesity, this study will help healthcare providers better understand the problem and allocate resources effectively. Identifying factors associated with sarcopenia will also help streamline diagnosis and monitoring for those at risk.

Начало: 26.05.2025 Край: 01.04.2027 Възраст: 21–100 г.

Singapore Singapore General Hospital NCT07541677

Набира участници Фаза 1/2

A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer

Gastric Cancer Adenocarcinoma Metastatic Gastroesophageal Adenocarcinoma

A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers

Начало: 26.05.2025 Край: 01.05.2029 Възраст: от 18 г. Лечение

Australia, South Korea, Taiwan Bolt Biotherapeutics, Inc. NCT06921837

Набира участници Фаза 1/2

A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)

Malignant Neoplasm

Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory: * Hepatoblastoma is a common liver cancer in babies and very young children * RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment The study treatment HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of HER3-DXd in children and if they tolerate it * What happens to HER3-DXd in children's bodies over time * If children who receive HER3-DXd have the cancer get smaller or go away

Начало: 26.05.2025 Край: 30.12.2030 Възраст: 1–17 г. Лечение

Australia, Belgium, Brazil +19 Merck Sharp & Dohme LLC NCT06941272

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Intelligent Lung Support in the Intensive Care Unit

Mechanical Ventilation Intensive Care Medicine

The aim of this observational study is to test the IntelliLung decision support system based on artificial intelligence. This system is intended to help to set the ventilator. The study includes patients with and without ARDS (acute respiratory distress syndrome) who are receiving invasive mechanical ventilation, as well as patients with additional extracorporeal lung support. The study will be conducted in several centers. The main question of the study: How well do the mechanical ventilation settings of healthcare staff match the recommendations of the IntelliLung system?

Начало: 25.05.2025 Край: 01.12.2027 Възраст: от 18 г.

Germany, Italy, Poland +1 Technische Universität Dresden NCT06595602

Набира участници Фаза 1

A First in Human Study of TT5 in Single and Multiple Ascending Doses in Healthy Volunteers and Surgical Patients

Pain

This study is a First in Human, three-parts, double-blind, randomized, placebo-controlled, single and multiple ascending dose study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 at different doses in healthy and surgical participants.

Начало: 23.05.2025 Край: 10.11.2026 Възраст: 18–55 г. Лечение

Australia Tafalgie Therapeutics NCT06789861

Набира участници Фаза 3

A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)

Endometrial Cancer

Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.

Начало: 22.05.2025 Край: 24.05.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Austria +31 Merck Sharp & Dohme LLC NCT06952504

Набира участници Фаза 2

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Idiopathic Hypersomnia

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Начало: 22.05.2025 Край: 01.06.2026 Възраст: 18–70 г. Лечение

Australia, Belgium, Czechia +5 Alkermes, Inc. NCT06843590

Набира участници Фаза 2/3

Safety and Efficacy of EIK1001 in Combo With Pembro Versus Placebo and Pembro as First-Line Therapy in Patients With Advanced Melanoma.

Advanced Melanoma

The study is for patients with advanced melanoma who are eligible for standard therapy with Pembrolizumab.

Начало: 22.05.2025 Край: 01.12.2040 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +15 Eikon Therapeutics NCT06697301

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Physical Functions and Lifestyle Behaviours in Post-COVID-19 Syndrome Based on Circadian Rhythms

Post-COVID-19 Syndrome

Post-COVID-19 syndrome is associated with persistent symptoms such as fatigue, reduced physical activity, and impaired respiratory function. Circadian rhythm differences (chronotype) may influence lifestyle behaviors including physical activity, nutrition, and sleep patterns. This observational cross-sectional study aims to compare respiratory muscle strength, physical activity levels, and nutritional habits among individuals with post-COVID-19 syndrome according to their chronotype (morning, intermediate, and evening types). Additionally, genetic analysis of the CLOCK gene polymorphism will be performed to support objective evaluation of circadian rhythm differences. The findings of this study may help to better understand the role of circadian rhythm in post-COVID-19 syndrome and contribute to the development of individualized rehabilitation and lifestyle interventions.

Начало: 22.05.2025 Край: 22.05.2027 Възраст: 18–65 г.

Turkey (Türkiye) Hacettepe University NCT07545499

Набира участници Фаза 3

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)

Primary Membranous Nephropathy

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys. Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure. In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease. The main question that researchers want to answer is: * How many participants achieve a complete response after 104 weeks of treatment? * A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable. Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * How many participants develop antibodies against felzartamab in the blood? * How many participants achieve a complete response after 76 weeks of treatment * How many participants have medical problems during the study * How felzartamab is processed by the body * How felzartamab affects participants' tiredness and overall physical health The study will be done as follows: * Participants will be screened to check if they can join the study. This may take up to 42 days. * Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets. * If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment. * If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104. * In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

Начало: 22.05.2025 Край: 29.03.2029 Възраст: 18–80 г. Лечение

Argentina, Australia, Brazil +7 Biogen NCT06962800

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Motor Outcomes to Validate Evaluations in Pediatric FSHD (MOVE Peds)

Muscular Dystrophy, Facioscapulohumeral

The primary goal of this study is to validate motor and functional outcomes and refine clinical trial strategies for pediatric-onset FSHD

Начало: 22.05.2025 Край: 01.05.2028 Възраст: 5–17 г.

Australia, United States University of Kansas Medical Center NCT06847282

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Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?

Irritable Bowel Syndrome (IBS) Intestinal Diseases Gastrointestinal Disease

This research project will assess how two treatments for irritable bowel syndrome (one dietary and one behavioral) work and for whom. This will be done by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works). Investigators will also assess how the diet and behavioral treatments affect IBS symptoms during treatment. Participants will be randomized to either: i. A FODMAP diet online program that focuses on modifying the consumption of foods high or moderate in fermentable carbohydrates (FODMAPS) to manage IBS symptoms. or, ii. An Exposure-based Cognitive Behavioral Therapy (E-CBT) online program for IBS that focuses on changing symptom-related behaviors which are known to worsen IBS symptoms.

Начало: 22.05.2025 Край: 01.07.2027 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT06940596

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Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes

T2DM

The intervention in this study consists of a 75-min intraduodenal infusion of an isotonic solution containing either of calcium chloride (CaCl2) or control (saline). Participants enrolled into the study will receive, in randomised, double-blind fashion (i) Saline (control), (ii) 500 mg CaCl2, or (iii) 1000 mg CaCl2 in three separate sessions, each of which will be separated by at least 4 (and up to 10) days. Each study session will be 4-6 hours. Studies will be carried out in the Clinical Research Facility of the Adelaide Medical School, the University of Adelaide, by staff and students trained in the required techniques.

Начало: 22.05.2025 Край: 28.04.2026 Възраст: 18–70 г. Друго

Australia University of Adelaide NCT06942195

Набира участници Фаза 3

A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer Metastatic Gastric Adenocarcinoma or Cancer Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy. Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections. The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

Начало: 22.05.2025 Край: 30.09.2028 Възраст: от 18 г. Лечение

Australia, Belgium, China +15 Astellas Pharma Global Development, Inc. NCT06901531

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A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome

IBS (Irritable Bowel Syndrome)

This prospective, interventional trial is intended to determine the safety and effectiveness of the Variable Compression System (VCS) device for Irritable Bowel Syndrome (IBS). This pilot study will enroll 20 subjects who will be required to wear the VCS device for a minimum of 6 hours a day and follow up at 21 days, 8 weeks, and 6 months post-device administration.

Начало: 21.05.2025 Край: 01.05.2026 Възраст: 18–60 г.

United States PGP Health NCT07540312

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Hip-allograft In Proximal Humerus Fractures Versus Plate Implantation Alone: a Randomized Controlled Trial

Proximal Humeral Fractures

Proximal humerus fractures (PHFs) are common osteoporotic fractures in adults and the elderly, leading to significant disability and reduced quality of life. Current treatment options for displaced PHFs include locking plate fixation (LCP) and various augmentation techniques, but there is no consensus on the optimal treatment. Although, femoral allografts have shown promising results, there is a need for more definitive evidence regarding the utilization of femoral graft augmentation in addition to locking plate fixation in 3- and 4-part PHFs. This study aims to evaluate the effectiveness of using a mushroom-shaped femoral allograft combined with LCP fixation compared to LCP fixation alone. We hypothesize that femoral allograft augmentation with LCP fixation will result in better clinical and functional outcomes than LCP fixation alone at 24 months post-operative

Начало: 21.05.2025 Край: 01.05.2029 Възраст: 40–70 г.

Netherlands Tergooi Medical Center NCT07538700

Набира участници Фаза 4

Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy

Allergic Reactions

The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.

Начало: 20.05.2025 Край: 01.06.2027 Възраст: от 4 г.

United States ARS Pharmaceuticals, Inc. NCT06834165

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