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Набира участници

Unravelling Energy Issues Underpinning Low Energy Availability in High Performance Athletes

Relative Energy Deficiency in Sport

The goal of this clinical trial is to understand how the body responds to short-term, severe low energy availability (LEA) in healthy, weight-bearing endurance athletes aged 18-45 years old. LEA describes a mismatch between an individual's dietary energy intake and the energy cost of their commitments for training and competition. The main questions this trial aims to answer are: 1. What effect does short-term, severe LEA have on sleeping metabolic rate? 2. What effect does short-term, severe LEA have on other body systems identified within the Relative Energy Deficiency in Sport (REDs) Health and Performance Conceptual models? Researchers will compare a control trial with both a LEA trial achieved through diet restriction and a LEA trial achieved through increased exercise to see if there are differences in the body's response. Participants will complete three 6-day trials, a minimum of 3-weeks apart, involving: * Prescribed diet (all food provided) * Prescribed running and/or cycling exercise * Two visits to ACU Fitzroy campus for blood tests and exercise testing * 50 hour stay (two nights and two days) in the ACU metabolic chamber

Начало: 01.06.2025 Край: 01.06.2027 Възраст: 18–45 г. Фундаментална наука

Australia Australian Catholic University NCT07026175

Набира участници Фаза 1/2

Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases

Melanoma Brain Metastases

Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM).

Начало: 31.05.2025 Край: 30.01.2026 Възраст: от 18 г. Лечение

Australia Melanoma and Skin Cancer Trials Limited NCT06163820

Набира участници Фаза 1

PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas

NF1 Mutation Neurofibroma Plexiform Neurofibroma, Plexiform Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs) +1

The main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1). The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PAS-004 might have. This study will have two parts, Part A and Part B. The main goal of Part A of this study is to learn more about how participants tolerate different doses of PAS-004, and what side effects PAS-004 might have. What we learn from Part A of the study will help decide what doses of the study drug (PAS-004) should be used in Part B of the study, and if it is safe. In Part B, two different doses from Part A will be tested. The main goal of this part of the study is to keep studying any side effects of PAS-004 at those two dose levels, and to learn more about if the doses picked for this part of the study might have an effect on plexiform neurofibromas. Participants in Part A of the study who were taking doses selected for Part B may be able to continue on to Part B and keep taking the same dose of PAS-004 for 6 more months. Study participants in both parts will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety, including blood draws and MRIs. Everyone participating in the study will take PAS-004 by mouth once a day during the study, in 28-day cycles. Participants will be asked to keep a diary to record their daily dose of study drug. Participants will continue on daily PAS-004 for up to 6 months, or until: * They decide to withdraw from the study, or * They experience unacceptable side effects, or * Their disease progresses, or another illness interferes with taking the study drug, or * The sponsor selects a dose level to study further in the next part of the study, or * The sponsor stops the study.

Начало: 30.05.2025 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, South Korea, United States Pasithea Therapeutics Corp. NCT06961565

Набира участници Фаза 1

Study of GS-3242 in Participants With HIV-1; Substudy-05

HIV-1-infection

This study is part of a master study. The goal of master protocol (GS-US-544-5905, NCT05585307) is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH). Substudy GS-US-544-5905-05 is to learn more about the study drug GS-3242 in PWH.

Начало: 29.05.2025 Край: 01.02.2027 Възраст: 18–65 г. Лечение

Mexico, Thailand, United States Gilead Sciences NCT07001319

Набира участници Фаза 2

A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)

Malignant Melanoma

Researchers want to learn if intismeran autogene with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Intismeran autogene is a study treatment designed to help a person's immune system attack their specific cancer. Pembrolizumab is an immunotherapy. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab live longer without the cancer growing or spreading than people who receive placebo with pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.

Начало: 29.05.2025 Край: 05.09.2031 Възраст: от 18 г. Лечение

Australia, Canada, France +8 Merck Sharp & Dohme LLC NCT06961006

Набира участници Фаза 3

A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.

Osteoarthritis, Knee

The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain. Study details include: * The study duration will be up to 64 weeks. * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period. * Approximately 466 participants will be enrolled into this study.

Начало: 29.05.2025 Край: 01.07.2027 Възраст: от 18 г. Лечение

Australia, United States Paradigm Biopharmaceuticals Ltd. NCT06917404

Набира участници Фаза 2

A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine

Advanced High-Grade Epithelial Ovarian Primary Peritoneal Fallopian Tube Cancers High Folate Receptor-Alpha Expression +1

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide. The total study duration will be approximately 24 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Начало: 28.05.2025 Край: 01.03.2028 Възраст: от 18 г. Лечение

Australia, Belgium, South Korea +3 AbbVie NCT06682988

Набира участници Фаза 1/2

A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration

Geographic Atrophy Secondary to Age-related Macular Degeneration

The goal of this study is to evaluate how safe and tolerable KRIYA-825 (VV-14295) is and to determine how effective it is in reducing the growth of geographic atrophy (GA) lesions in the treated eye in patients with GA secondary to age-related macular degeneration (AMD).

Начало: 28.05.2025 Край: 15.12.2027 Възраст: 55–80 г. Лечение

Canada, New Zealand Kriya Therapeutics, Inc. NCT06765980

Набира участници Фаза 1

Evaluating the Safety and Tolerability of Orally Administered DF-003 in ROSAH Syndrome Patients

ROSAH

The purpose of this study is to evaluate the safety and tolerability of DF-003 in retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and migraine headache (ROSAH) syndrome patients.

Начало: 27.05.2025 Край: 01.05.2026 Възраст: 18–65 г. Лечение

Australia, United States Shanghai Yao Yuan Biotechnology Ltd. (also known as Dru NCT06395285

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

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

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

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

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

Набира участници

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

Набира участници

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

Набира участници Фаза 4

A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma

The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.

Начало: 20.05.2025 Край: 01.12.2032 Възраст: от 18 г. Лечение

Australia, France, Italy +5 Eli Lilly and Company NCT06876649

Набира участници Фаза 4

A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma

Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.

Начало: 20.05.2025 Край: 01.12.2032 Възраст: от 18 г. Лечение

Australia, France, Italy +5 Eli Lilly and Company NCT06876662

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