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Набира участници Фаза 3

A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer

HPV-Related Squamous Cell Carcinoma

The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following: * Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy * How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.

Начало: 19.08.2024 Край: 01.08.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT06563479

Набира участници Фаза 2

A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

Acute HIV Infection

A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether: * Administration of combination HIV-specific broadly neutralizing antibody (bNAb) therapy in addition to ART during acute HIV infection (AHI) will be safe. * Participants who receive combination bNAb therapy in addition to ART during AHI will be more likely to demonstrate a delay in time to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks compared to participants who receive placebo plus ART. * Participants who receive combination bNAb therapy in addition to ART during AHI will demonstrate lower viral reservoirs and enhanced HIV-specific immunity compared to participants who receive placebo plus ART.

Начало: 19.08.2024 Край: 06.09.2028 Възраст: 18–70 г.

Brazil, Peru, United States National Institute of Allergy and Infectious Diseases ( NCT05719441

Набира участници Фаза 2

VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH UNCONTROLLED ARTERIAL HYPERTENSION - ENDOTHELIN-2

Uncontrolled arterial hypertension

Trial status: Authorised 8 week change in peripheral and central arterial pressures and arterial stiffness, 8-week change in local concentrations of NO, EETs and ET-1 with sustained increase in blood flow, Variation in 8 weeks of natriuresis and measured glomerular filtration rate (DTPA labeled by the technetium 99m) 8-week change in amplitude of endothelium-dependent radial artery dilatation with sustained increase in blood flow

Начало: 19.08.2024 Възраст: от 18 г.

France Centre Hospitalier Universitaire Rouen 2024-515928-36-00

Набира участници Фаза 1

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

Antiphospholipid Syndrome (APS) Bullous Pemphigoid (BP) Behçet's Syndrome (BS) Dermatomyositis (DM) +2

This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).

Начало: 19.08.2024 Край: 30.06.2026 Възраст: 18–85 г. Лечение

Australia, Bulgaria, Canada +15 Chugai Pharmaceutical NCT06371417

Набира участници Фаза 3

A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement. Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab. 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. The effect of the treatment will be checked by clinical assessments, blood tests, checking for side effects and completing questionnaires.

Начало: 19.08.2024 Край: 01.07.2030 Възраст: 2–11 г. Лечение

Argentina, Australia, Brazil +21 AbbVie NCT06461897

Набира участници Фаза 1/2

Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)

B-cell Acute Lymphoblastic Leukemia Diffuse Large B-cell Lymphoma Burkitt Lymphoma Neuroblastoma +1

Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.

Начало: 16.08.2024 Край: 31.03.2029 Възраст: 6–25 г. Лечение

Australia, Belgium, Brazil +19 Merck Sharp & Dohme LLC NCT06395103

Набира участници Фаза 1

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

Alzheimer Disease

The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD. The study will be comprised of two parts, A and B. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. Each participant in Part B will receive 2 doses of either LY3954068 or placebo administered into the spinal fluid. Participants will have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. The study will last up to approximately 45 weeks for Part A, and 100 weeks for Part B, including the screening period.

Начало: 15.08.2024 Край: 01.02.2027 Възраст: 50–85 г.

Japan, United Kingdom, United States Eli Lilly and Company NCT06297590

Набира участници

EarGenie MVP Performance Evaluation

Hearing Impaired Children

This is a single-group clinical trial to evaluate the performance of the EarGenie minimum viable product (MVP) in normal hearing infants. The EarGenie MVP tests for detection and discrimination of sounds will be administered, and the sensitivity and specificity of the tests will be estimated for a range of sound levels (detection) and speech sound contrasts (discrimination).

Начало: 15.08.2024 Край: 15.12.2025 Възраст: 1–24 г. Диагностика

Australia The Bionics Institute of Australia NCT06406088

Набира участници

First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease

Superficial Femoral Artery Stenosis Popliteal Artery Stenosis

This is a prospective, open label, multicenter, single arm, first in human clinical study. Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled. The patients will be treated with the ChampioNIR Stent System. All implanted patients will be followed up at 30 days and 6, 12, 24 and 36 months. The follow-up visits will include patency evaluation by duplex ultrasound

Начало: 15.08.2024 Край: 28.02.2030 Възраст: 18–120 г. Лечение

Australia, United States Medinol Ltd. NCT06410313

Набира участници Фаза 1

Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors

Metastatic Pancreatic Neuroendocrine Tumor Pancreatic Neoplasm Stage III Pancreatic Neuroendocrine Tumor AJCC v8 Stage IV Pancreatic Neuroendocrine Tumor AJCC v8 +1

This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.

Начало: 14.08.2024 Край: 14.12.2026 Възраст: от 18 г.

Canada, United States National Cancer Institute (NCI) NCT05687123

Набира участници Фаза 2

A Study to Evaluate Solrikitug in Participants With COPD (ZION)

COPD

A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).

Начало: 14.08.2024 Край: 31.10.2026 Възраст: 40–75 г. Лечение

Australia, Canada, New Zealand +2 Uniquity One (UNI) NCT06496620

Набира участници Фаза 1/2

A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

Breast Cancer

In the phase I part, to determine the recommended doses (RD) and dosing regimens of \[177Lu\]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of \[177Lu\]Lu-NeoB in combination with capecitabine (dose optimization).

Начало: 14.08.2024 Край: 09.09.2031 Възраст: 18–100 г. Лечение

Australia, Canada, China +10 Novartis Pharmaceuticals NCT06247995

Набира участници Фаза 2

Working Out M0 Bipolar Androgen Therapy

Prostate Cancer

The WOMBAT study will test if BAT can prolong the time it takes for nmCRPC prostate cancer to become detectable in other areas of the body (metastatic disease). Approximately 69 participants over the age of 18 with castrate resistant prostate cancer, no evidence of metastatic disease (M0) on conventional imaging (WBBS and CT scan at screening) and PSA only progression on darolutamide will be enrolled from approximately 8 sites within Australia. Participants will receive continuous androgen deprivation therapy with LHRH agonists/antagonists. The study intervention will be IM testosterone enthanate, injected on day 1 of each 56-day cycle. Concurrent darolutamide will be taken at a dose of 600mg BD on days 29-56 of each cycle. Both LHRH and agonist/antagonist and darolutamide are supplied through the PBS as standard of care medications. Administration of both testosterone and darolutamide will continue until disease progression, beyond disease progression, unacceptable toxicity, death, withdrawal of consent or study Sponsor termination of the study. Primary objective (endpoint) is to determine the metastasis-free survival (time from commencing BAT to evidence of metastases or death)

Начало: 14.08.2024 Край: 31.12.2028 Възраст: от 18 г. Лечение

Australia Australian and New Zealand Urogenital and Prostate Canc NCT06594926

Набира участници

J-RISE: Relevant Implementation Strategies to Eliminate the Social and Structural Barriers to HIV Services Among Justice-involved Black Men Who Have Sex With Men and Other Key Populations

HIV Contingency Management Justice Involved Populations Status Neutral Interventions +2

The goal of this clinical trial is to compare two interventions - Health Navigation and Health Navigation Plus among individuals who have been impacted by the criminal legal system. The main question it aims to answer is: • Compared with the Health Navigation group, are participants in the Health Navigation Plus group more likely to a) access HIV care, treatment, and prevention services and employment services and b) access employment services and be employed in community? Participants on the study will be: * Randomly assigned (like a flip of a coin) to participate in either Health Navigation or Health Navigation Plus. Participants will have an equal chance of being placed in either group. * Complete three surveys over the course of 13 months * Participants in the Health Navigation group will have two in person meetings and seven check-ins with the health navigator over 6 months * Participants in the Health Navigation Plus group will have two in person meetings and seven check-ins with the health navigator over 6 months, two in person and 10 check ins with the employment navigator over 12 months and up to $200 to support employment and career development needs and receive up to $140 to support health goals. Samples of blood, urine and swabs may be collected to meet the health goals.

Начало: 13.08.2024 Край: 30.06.2028 Възраст: от 18 г.

United States University of Chicago NCT06477588

Набира участници Фаза 3

A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

Metastatic HER2-positive Breast Cancer

The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.

Начало: 13.08.2024 Край: 18.10.2030 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +11 Jazz Pharmaceuticals NCT06435429

Набира участници Фаза 3

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)

Kidney Disease, Chronic

This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart disease. This study has 2 parts. In the first part, participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks. Participants continue taking ACEi or ARB throughout the study if such treatments are indicated. In the second part, participants are divided into 2 groups by chance. One group takes BI 690517 tablets and the other group takes placebo tablets. Placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants take 1 tablet once a day in addition to empagliflozin for the duration of the study. The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 4 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney function, and take note of any unwanted effects.

Начало: 13.08.2024 Край: 30.08.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +14 Boehringer Ingelheim NCT06531824

Набира участници

SuperSaturated Oxygen Comprehensive Observational Registry

STEMI - ST Elevation Myocardial Infarction AMI

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SuperSaturated Oxygen (SSO2) Therapy versus percutaneous coronary intervention (PCI) alone among patients with anterior acute myocardial infarction (AMI) in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall heart failure (HF) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.

Начало: 13.08.2024 Край: 31.03.2029 Възраст: от 18 г.

United States TherOx NCT06438315

Набира участници

Sleep Mechanisms Of Regulating Emotions

Insomnia Depression

This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target.

Начало: 12.08.2024 Край: 01.06.2027 Възраст: 18–65 г.

United States Stanford University NCT06373718

Набира участници Фаза 3

Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

Biliary Tract Cancer

The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

Начало: 12.08.2024 Край: 16.05.2029 Възраст: 18–99 г. Лечение

Australia, Belgium, Brazil +23 AstraZeneca NCT06467357

Набира участници Фаза 3

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

Crohn's Disease

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given (UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Начало: 08.08.2024 Край: 01.12.2034 Възраст: 2–17 г. Лечение

Australia, Belgium, Brazil +15 AbbVie NCT06332534

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