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Набира участници Фаза 1

A Study of LY3971297 in Healthy Participants

Healthy Obesity Hypertension

The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.

Начало: 07.12.2023 Край: 01.09.2026 Възраст: 18–75 г.

Japan, Singapore, United States Eli Lilly and Company NCT06148272

Набира участници Фаза 3

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Non-small Cell Lung Cancer

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Начало: 06.12.2023 Край: 21.12.2035 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +30 Merck Sharp & Dohme LLC NCT06077760

Набира участници Фаза 3

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

Choroidal Melanoma Indeterminate Lesions Uveal Melanoma Ocular Melanoma

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

Начало: 06.12.2023 Край: 15.08.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +10 Aura Biosciences NCT06007690

Набира участници Фаза 1/2

A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer

Solid Tumor Metastatic Cancer Unresectable Solid Tumor Recurrent Solid Tumor +2

The purpose of this first-in-human (FIH) study is to determine the maximum tolerated dose (MTD) and to characterize the safety, tolerability, PK, and dosimetry profile of \[177Lu\]Lu-SN201 in adult participants with advanced solid tumors who have no standard of care treatment options. \[177Lu\]Lu-SN201 is a radiolabeled, nanomedical investigational medicinal product (IMP) whose mechanism of delivery is based on the Enhanced Permeability and Retention (EPR) effect.

Начало: 06.12.2023 Край: 31.12.2027 Възраст: от 18 г. Лечение

Australia Spago Nanomedical AB NCT06184035

Набира участници

Performance of the Treatment of Periodontitis According to the Bioperio® Protocol

Periodontitis

This multicenter, prospective, single-arm observational study evaluated the clinical performance of the Bioperio® protocol, a standardized, patient-centered framework for managing periodontitis. The protocol combined professional supra-gingival scaling, oral hygiene instruction and motivation, full-mouth subgingival instrumentation, and-in Stage III/IV cases-adjunctive enamel matrix derivative application in deep pockets.

Начало: 05.12.2023 Край: 05.12.2030 Възраст: от 18 г.

Italy University of Pisa NCT07507474

Набира участници

Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Prostate Cancer

This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.

Начало: 05.12.2023 Край: 31.12.2028 Възраст: от 18 г.

United States State University of New York at Buffalo NCT06172283

Набира участници

Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)

Chronic Subdural Hematoma

This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.

Начало: 05.12.2023 Край: 01.08.2026 Възраст: от 18 г.

Australia, Canada, United States Montefiore Medical Center NCT06181994

Набира участници Фаза 1/2

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

Multiple Myeloma

This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM.

Начало: 05.12.2023 Край: 16.08.2027 Възраст: от 18 г. Лечение

Australia, Canada, China +5 AstraZeneca NCT06106945

Набира участници Фаза 1/2

A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

ER+ HER2- Advanced Breast Cancer High-grade Serous Ovarian Cancer (HGSOC)

This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.

Начало: 05.12.2023 Край: 04.08.2027 Възраст: от 18 г. Лечение

Australia, South Korea, Spain +2 AstraZeneca NCT06188520

Набира участници Фаза 2

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.

Начало: 05.12.2023 Край: 01.02.2028 Възраст: 18–75 г. Лечение

Australia, Belgium, Canada +10 Gilead Sciences NCT06029972

Набира участници Фаза 1

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Myeloproliferative Neoplasms

This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms.

Начало: 04.12.2023 Край: 29.10.2028 Възраст: от 18 г.

United States Incyte Corporation NCT06034002

Набира участници

Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?

Valve Stenoses, Aortic

Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.

Начало: 04.12.2023 Край: 01.08.2026 Възраст: от 18 г. Друго

Australia The Alfred NCT06284837

Набира участници

Lung MRI in Paediatric Lung Disease: MRI in PBB

Protracted Bacterial Bronchitis (PBB)

Protracted bacterial bronchitis (PBB) is a problem in the lungs causing children to have a wet cough for more than 4 weeks. PBB is also known to start before and cause other lung diseases and to affect children's quality of life. It is difficult to know if a child has PBB. Listening to the lungs and measuring a child's breathing are usually normal and so a bronchoscopy (looking in the lungs with a camera) and a type of lung scan called CT are needed to diagnose PBB. These tests involve children being put to sleep under anaesthetic (bronchoscopy) or exposed to radiation (CT) and so are not performed often. PBB is difficult to treat and antibiotics are given for many weeks to make children better. Often this doesn't stop the cough and antibiotics need to be injected into the child to treat the infection. Children have to take large amounts of antibiotics and have regular physiotherapy to help their cough. The only way to know if a child is better is when their parents report their cough has improved which is often unreliable. In this study we will take pictures of children's lungs using a type of scan called MRI, which is safe and does not expose children to radiation. Children breathe in a gas called xenon which fills the lungs. If there is phlegm blocking parts of the lungs, the gas cannot get through and we can see the blockage. This type of picture is the best way to measure early lung disease in children with other lung conditions such as cystic fibrosis and bronchiectasis. Measuring lung disease early will make children with PBBs lives better and mean they have to take less antibiotics. In some children, it will also help to stop lifelong lung diseases such as bronchiectasis.

Начало: 01.12.2023 Край: 31.05.2026 Възраст: 5–17 г.

United Kingdom Sheffield Children's NHS Foundation Trust NCT07545304

Набира участници Фаза 3

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

NASH With Fibrosis MASH With Fibrosis

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Начало: 01.12.2023 Край: 01.11.2032 Възраст: 18–80 г. Лечение

Argentina, Australia, Canada +15 Akero Therapeutics, Inc NCT06215716

Набира участници

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Invasive Fungal Infections

This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.

Начало: 01.12.2023 Край: 01.04.2027 Възраст: от 18 г.

Australia Peter MacCallum Cancer Centre, Australia NCT06105411

Набира участници Фаза 1

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

Advanced Solid Tumor Advanced Breast Cancer Metastatic Breast Cancer Hormone-receptor-positive Breast Cancer +5

This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

Начало: 01.12.2023 Край: 01.11.2028 Възраст: от 18 г. Лечение

Australia, Brazil, China +8 BeOne Medicines NCT06120283

Набира участници

An Observational Study to Learn More About the Use of Vericiguat in Korean People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in Real-world Setting

Chronic Heart Failure With Reduced Ejection Fraction

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in people with chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a long-term condition in which the heart does not pump blood as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and death. The study treatment vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). sGC helps to regulate the heart and blood circulation. Vericiguat has already been studied in previous clinical studies and is available for doctors to prescribe to people with heart failure. This study will collect important data from real-world setting in Korea. The participants of this study are people with HFrEF who will receive vericiguat as prescribed by their doctors according to the approved product information The main purpose of this study is to learn more about how safe vericiguat is in the participants. To do this, researchers will collect data on all medical problems (also called adverse events) that the participants have during the study. Doctors keep track of all adverse events, even if they do not think they might be related to the study treatment. Further, researchers will collect data on how well vericiguat works and treatment patterns in the participants. For this, the following information will be collected: * occurrence of death due to heart and circulatory events * hospital stays due to heart conditions (failure) * dose levels of vericiguat and duration of treatment The data for this study will come from medical records and visits that take place in routine practice. Participants will be treated with vericiguat and observed up to 12 months or until death or they leave the study, whatever comes first.

Начало: 30.11.2023 Край: 31.10.2027 Възраст: от 19 г.

South Korea Bayer NCT06148935

Набира участници Фаза 3

Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)

Soft Tissue Sarcoma

To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Начало: 29.11.2023 Край: 30.12.2027 Възраст: 18–99 г.

Canada, Taiwan, United States Polaris Group NCT05712694

Набира участници Фаза 3

Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 HER2-Negative Breast Carcinoma Hormone Receptor-Positive Breast Carcinoma

This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.

Начало: 27.11.2023 Край: 31.05.2026 Възраст: от 18 г.

Puerto Rico, United States National Cancer Institute (NCI) NCT06058377

Набира участници Фаза 1

Study of Intravenous ZMA001 in Healthy Subjects

Pulmonary Arterial Hypertension PAH

Background: A number of diseases can cause a type of lung injury called pulmonary arterial hypertension (PAH). Most people who develop PAH do not survive more than a few years. A new study drug (ZMA001) may help. ZMA001 is a monoclonal antibody. This type of drug consists of proteins, made in a facility, that are very similar to proteins in a human body. But before giving ZMA001 to people sick with PAH, researchers want to find out how the drug affects healthy people. Objective: To test a drug (ZMA001) in healthy volunteers. Eligibility: Healthy adults aged 18 to 60 years. Design: Participants will be screened. They will have a physical exam with blood tests. They will have a urine test for drug use. They will have a test of their heart function. Participants will come to the clinic for 1 inpatient visit of up to 48 hours. ZMA001 is a liquid administered through a tube attached to a needle inserted into a vein in the arm. Participants will receive this drug only once, during their inpatient stay. Some participants will receive the drug; others will receive a placebo in Cohort 1 only. A placebo is a treatment that looks just like the real drug but contains no medicine. Participants will not know which treatment they are getting in Cohort 1. Cohorts 2-4 will receive a single dose of the study drug, administered through a tube attached to a needle inserted into a vein in the arm. After a screening visit, participants will have 1 inpatient visit and up to 8 outpatient visits over 16 weeks after receiving the treatment. Blood draws and other tests will be repeated. Each outpatient visit is approximately 2 hours long. This study is the first time ZMA001 will be administered to people.

Начало: 27.11.2023 Край: 30.11.2027 Възраст: 18–60 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT05967299

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