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NCT ID: NCT05208047 Recruiting - Metastatic Cancer Clinical Trials

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Start date: April 14, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner.

NCT ID: NCT05206773 Recruiting - Fabry Disease Clinical Trials

A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease

PERIDOT
Start date: March 11, 2022
Phase: Phase 3
Study type: Interventional

This is a 12-month, parallel treatment, Phase 3, double-blind, randomized, placebo controlled study to evaluate the effect of venglustat on neuropathic and abdominal pain symptoms of Fabry disease in participants ≥16 years of age with Fabry disease who are treatment-naïve or untreated for at least 6 months. - Study visits will take place approximately every 3 months. - The double-blind period will be followed by an open-label extension (OLE) during which participants who have completed the double-blind period will be treated with venglustat for up to an additional 12 months.

NCT ID: NCT05201794 Recruiting - Dengue Clinical Trials

A Study of JNJ-64281802 for the Prevention of Dengue Infection

Start date: February 22, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline.

NCT ID: NCT05179980 Recruiting - Clinical trials for Entrustable Professional Activities

Comprehensive Model for Evaluation of Surgical EPAs

Start date: March 1, 2020
Phase:
Study type: Observational

Introduction. Competency-based medical education (CBME) frameworks have become increasingly prevalent among surgical education accreditation bodies. Medical schools, postgraduate training programs, and licensing bodies conduct assessments to certify the competence of future practitioners, and judge the adequacy of training programs. Methods. A prospective cohort study was designed to evaluate clinical-surgical competencies in all residents of a general surgery program. All medical residents of the general surgery program of the Faculty of Medicine and Biomedical Sciences at the Autonomous University of Chihuahua, were video recorded with consent, in the field (Outpatient consultation, Surgical ward, Inpatient room, Classroom), for posterior evaluation by the professors of the program with electronic rubrics made with Google forms.

NCT ID: NCT05171647 Recruiting - Clinical trials for Non-Hodgkin Lymphoma

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

SUNMO
Start date: April 25, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).

NCT ID: NCT05166889 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

OBERON
Start date: January 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

NCT ID: NCT05166161 Recruiting - Phenylketonuria Clinical Trials

A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria

Start date: February 14, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the long-term safety of PTC923 in participants with phenylketonuria, and to evaluate the changes from baseline in dietary phenylalanine (Phe)/protein consumption.

NCT ID: NCT05164172 Recruiting - Migraine Clinical Trials

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

REJOIN
Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

NCT ID: NCT05163314 Recruiting - Clinical trials for Dravet Syndrome (DS)

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

Start date: March 4, 2022
Phase: Phase 3
Study type: Interventional

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

NCT ID: NCT05161195 Recruiting - Clinical trials for Metastatic Breast Cancer

Roll-over Study to Allow Continued Access to Ribociclib

Start date: July 7, 2022
Phase: Phase 4
Study type: Interventional

This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.