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NCT ID: NCT04109950 Terminated - Schizophrenia Clinical Trials

A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

Start date: October 4, 2019
Phase: Phase 3
Study type: Interventional

This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed with schizophrenia and have completed Study SEP361-301 or SEP361-302. This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.

NCT ID: NCT04107298 Completed - Clinical trials for Peripheral Arterial Disease

Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon

SWING
Start date: June 29, 2020
Phase: N/A
Study type: Interventional

To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.

NCT ID: NCT04101227 Completed - Clinical trials for Alcohol Use Disorder

Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms

ONWARD
Start date: February 1, 2020
Phase: Phase 3
Study type: Interventional

Randomized, multi-center, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo orally twice-daily for 24 weeks in conjunction with brief psychological counseling. Randomization will be stratified by: 1. Level of alcohol consumption prior to enrollment in the study (heavy drinkers averaging <10 drinks per day of drinking or very heavy drinkers averaging ≥10 drinks per day of drinking), and 2. Gender (male or female).

NCT ID: NCT04092686 Completed - Schizophrenia Clinical Trials

A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.

NCT ID: NCT04089566 Completed - Clinical trials for Muscular Atrophy, Spinal

Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

DEVOTE
Start date: March 26, 2020
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C). The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).

NCT ID: NCT04075084 Recruiting - Atrial Fibrillation Clinical Trials

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

BIOSTREAM-ICM
Start date: October 28, 2019
Phase:
Study type: Observational [Patient Registry]

This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.

NCT ID: NCT04059484 Active, not recruiting - Clinical trials for Breast Cancer Metastatic

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

AMEERA-3
Start date: October 22, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: - To compare the overall survival in the 2 treatment arms - To assess the objective response rate in the 2 treatment arms - To evaluate the disease control rate in the 2 treatment arms - To evaluate the clinical benefit rate in the 2 treatment arms - To evaluate the duration of response in the 2 treatment arms - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms - To evaluate the pharmacokinetics of amcenestrant as single agent - To evaluate health-related quality of life in the 2 treatment arms - To compare the overall safety profile in the 2 treatment arms

NCT ID: NCT04049266 Terminated - Clinical trials for Wet Macular Degeneration

A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.

DAZZLE
Start date: September 30, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).

NCT ID: NCT04033445 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

QUASAR
Start date: September 26, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT04022109 Recruiting - Gastric Cancer Clinical Trials

Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach

VOGAS
Start date: November 1, 2019
Phase:
Study type: Observational

The study is aimed to determine the potential of volatile marker testing for gastric cancer screening. The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.