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NCT ID: NCT06010914 Recruiting - Clinical trials for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer

DADOX
Start date: October 9, 2023
Phase:
Study type: Observational

This is an observational study in which only data are collected from participants receiving their usual treatment. In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT). ADT lowers the level of testosterone, a male hormone, and slows down the growth of cancer cells. Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer. It works by stopping the growth and spread of cancer cells. Darolutamide in combination with docetaxel and ADT is an approved treatment for men with mHSPC. It was approved based on a study called ARASENS. More information is needed on how safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC. The main purpose of this study is to collect information about the safety of this combination treatment in Japanese participants with mHSPC under real-world conditions. The main information that researchers will collect: Number and severity of heart-related medical problems participants have during the treatment Other information that researchers will collect: Number and severity of all medical problems participants have during the study Age and other information about the participants such as their illness, medical history, and other medicines taken at the same time Treatment pattern of darolutamide such as the amount of medicine given, the duration for which it is given, and any changes made to the treatment Data will be collected from August 2023 to July 2026. Researchers will observe participants from the start of darolutamide treatment until 30 days after they receive their last dose of docetaxel, which is expected to be approximately 6 months for each participant. In this study, data from regular health visits will be collected. No visits or tests are required as part of this study.

NCT ID: NCT06010173 Recruiting - CNS Lesion Clinical Trials

Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

Start date: July 21, 2023
Phase: Phase 3
Study type: Interventional

This trial conducted in Japan includes 2 different cohorts of patients: adult patients and pediatric patients with two different designs. - The cohort of adult patients has a prospective, multi-center, randomized, double-blind, controlled, and cross-over design. - The cohort of pediatric patients has a prospective, multi-center, non-randomized, open-label and single arm design. Primary objective to demonstrate the non-inferiority of gadopiclenol-enhanced MRI at 0.05 mmol/kg body weight (BW) compared to gadobutrol-enhanced MRI at 0.1 mmol/kg BW in terms of lesion visualization is applicable for adult patients referred for contrast-enhanced MRI of Central Nervous System (CNS) or Body regions.

NCT ID: NCT06008756 Recruiting - Arteriosclerosis Clinical Trials

MK-0616 (Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Start date: October 9, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.

NCT ID: NCT06007222 Recruiting - Aortic Stenosis Clinical Trials

Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

Start date: April 6, 2023
Phase: Phase 4
Study type: Interventional

Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period. Non-antithrombotic group: No antithrombotic agents will be administered after randomization until the end of the study period.

NCT ID: NCT06005493 Recruiting - Gastric Cancer Clinical Trials

Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

Start date: July 11, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.

NCT ID: NCT06003426 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Start date: September 14, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

NCT ID: NCT06002490 Recruiting - Clinical trials for Polycythemia Vera (PV)

A Study to Evaluate P1101 in Japanese PV Patients

Start date: October 17, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3 single arm study to investigate efficacy and safety of P1101's rapid titration for adult Japanese patients with PV.

NCT ID: NCT05999994 Recruiting - Neoplasms Clinical Trials

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

CAMPFIRE
Start date: January 22, 2020
Phase: Phase 2
Study type: Interventional

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

NCT ID: NCT05999799 Recruiting - Dermatitis, Atopic Clinical Trials

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis

Start date: November 16, 2023
Phase: Phase 2
Study type: Interventional

This study is parallel group, placebo-controlled dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of GSK1070806 in adult participants with moderate to severe Atopic Dermatitis (AtD), who have previously been treated with medicated topical treatments or a biologic therapy.

NCT ID: NCT05988073 Recruiting - Clinical trials for Multifocal Motor Neuropathy

A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy

Start date: November 29, 2023
Phase:
Study type: Observational

This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy over time and collect data on their clinical outcomes, quality of life, and use of health care resources. Participants will follow their regular visit schedule with their treating physician, except for an optional second visit occurring 7 to 14 days after the start of the study to collect biomarker data. No IMP will be administered.