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Набира участници

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

Набира участници

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 1/2

Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)

Von Willebrand Diseases

The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.

Начало: 16.03.2023 Край: 01.12.2029 Възраст: 12–60 г. Лечение

Australia, Brazil, Canada +4 Vega Therapeutics, Inc NCT05776069

Набира участници

Observational Study Protocol: LIVER-R

Hepatobiliary Cancers

Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multicountry, multicenter, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of durvalumab-based regimens in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, recurrence-free survival, and time to treatment recurrence).

Начало: 16.03.2023 Край: 30.12.2030 Възраст: 18–130 г.

Australia, Belgium, Brazil +17 AstraZeneca NCT06252753

Набира участници Фаза 1/2

Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).

Prostate Cancer Metastatic Castration-resistant Prostate Cancer Metastatic Hormone Sensitive Prostate Cancer

This is a prospective, open-label, dose-escalation and randomized dose optimization and expansion study. The Phase Ib portion of the study aims to determine the safety and tolerability of escalating doses of \[212Pb\]Pb-ADVC001 administered every 6, 4, 2 or 1 week(s) and establish the recommended phase 2 doses (RP2D). The Phase 2a expansion aims to assess the efficacy and safety of \[212Pb\]Pb-ADVC001 at the RP2 doses in 3 participant groups.

Начало: 15.03.2023 Край: 01.06.2029 Възраст: от 18 г. Лечение

Australia AdvanCell Pty Limited NCT05720130

Набира участници Фаза 3

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer

GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine + Bevacizumab as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

Начало: 15.03.2023 Край: 01.05.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +19 AbbVie NCT05445778

Набира участници

The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study

Cancer of Stomach Oesophageal Cancer Gastric Cancer Gastric Adenocarcinoma +5

To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions

Начало: 14.03.2023 Край: 14.09.2028 Възраст: от 18 г.

Australia Western Sydney Local Health District NCT05804331

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

Набира участници Фаза 1/2

A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

Clear Cell Renal Cell Cancer (ccRCC) Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) Urothelial Carcinoma (UC) +5

The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \[68Ga\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \[maximum tolerated dose (MTD) or lower dose\] for \[177Lu\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \[177Lu\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \[68Ga\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \[68Ga\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.

Начало: 14.03.2023 Край: 01.03.2029 Възраст: от 18 г. Лечение

Australia, France ITM Oncologics GmbH NCT05706129

Набира участници

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 Фаза 1/2

A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

B-cell Lymphoma Non-Hodgkin Lymphoma B-cell Malignancy Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) +4

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.

Начало: 10.03.2023 Край: 01.02.2030 Възраст: от 18 г. Лечение

Australia, United States CRISPR Therapeutics AG NCT05643742

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 Фаза 3

Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein

Alpha1-Antitrypsin Deficiency

The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.

Начало: 06.03.2023 Край: 14.08.2030 Възраст: 18–75 г. Лечение

Australia, Belgium, Brazil +12 Takeda NCT05677971

Набира участници Фаза 2/3

A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma

High Grade Osteosarcoma Localized Osteosarcoma Metastatic Osteosarcoma Secondary Osteosarcoma

This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.

Начало: 03.03.2023 Край: 20.03.2030 Възраст: до 40 г. Лечение

Australia, Canada, New Zealand +1 National Cancer Institute (NCI) NCT05691478

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

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

Tricuspid Regurgitation Tricuspid Valve Disease Tricuspid Valvular Disorders

The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.

Начало: 01.03.2023 Край: 30.12.2030 Възраст: от 18 г. Лечение

Australia, Belgium, Czechia +6 VDyne, Inc. NCT05797519

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

Набира участници Фаза 1

First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma

Advanced/Metastatic Solid Tumors Relapse/Refractory Lymphoma

For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.

Начало: 01.03.2023 Край: 31.03.2026 Възраст: от 18 г. Лечение

Australia, China EpimAb Biotherapeutics (Suzhou)Co., Ltd. NCT05607498

Набира участници

Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax

Chronic Lymphocytic Leukemia (CLL) Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia Mantle Cell Lymphoma Sudden Cardiac Death +2

Background: Bruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart. Objective: To identify and monitor the effects of BTKi on the heart. Eligibility: People aged 18 and older currently receiving or planning to receive BTKi or venetoclax. Design: Participants who have not yet started BTKi will have 2 required clinic visits: 1 before they start taking BTKi, and 1 about 6 months later. Participants who are already taking BTKi will have 1 required visit. Participants will undergo multiple tests: A physical exam, including collection of blood and saliva. A test that measures heart activity via stickers placed on the chest. A test that uses sound waves to capture images of the heart. An exercise stress test that monitors heart activity and blood pressure while the participant works on a treadmill or stationary bike. Sound wave images of the heart may also be taken while the participant exercises. Stress magnetic resonance imaging (MRI) may be done in place of an exercise test. Participants will lie on a table that slides into a tube. They will be given drugs to stress the heart while images are taken. Participants may wear a device to monitor their heart at home. Participants may have repeat visits if they develop heart symptoms or if they need to stop taking BTKi. They will have follow-up phone calls each year for up to 3 years.

Начало: 01.03.2023 Край: 08.04.2027 Възраст: 18–110 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT05724121

Набира участници Фаза 3

A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer

Metastatic Colorectal Cancer

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), achieved by HX008 or Investigator's Choice Chemotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC).

Начало: 28.02.2023 Край: 20.10.2028 Възраст: от 18 г.

China Taizhou Hanzhong biomedical co. LTD NCT05652894

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