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NCT ID: NCT04632225 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis

REViVALS-1A
Start date: February 9, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety of intramuscular (IM) administration of Engensis in Participants with Amyotrophic Lateral Sclerosis (ALS) as compared to Placebo. Safety will be assessed by incidences of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), injection site reactions (ISRs) and other adverse events of special interest (AESIs), and the clinically significant laboratory values after injections of Engensis compared to Placebo. Exploratory endpoints include assessment of muscle function using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) and ALSFRS-R subscores for Fine and Gross Motor Function; muscle strength by quantitative testing using handheld dynamometry (HHD) and the Accurate Test of Limb Isometric Strength (ATLIS) where available; quality of life using the ALS Assessment Questionnaire (ALSAQ-40); patient global impression of change (PGIC), clinical global impression of change (CGIC), and clinical global impression of severity (CGIS); and evaluation of lung function using Slow Vital Capacity (SVC). Muscle biopsies will be performed during the study for future biomarker analyses.

NCT ID: NCT04632030 Completed - Tobacco Use Clinical Trials

Shrinking the Size of the Tobacco Power Wall

Start date: October 30, 2020
Phase: N/A
Study type: Interventional

The overall aim of this research is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents.

NCT ID: NCT04631796 Completed - Refractive Errors Clinical Trials

Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

Start date: December 3, 2020
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.

NCT ID: NCT04631718 Completed - Iron Overload Clinical Trials

MRI QSM Imaging for Iron Overload

Start date: January 18, 2022
Phase:
Study type: Observational

The overall goal of this project is to develop and validate a novel technique for Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM) of the abdomen, for non-invasive assessment of liver iron deposition. In this work, study team will develop and optimize advanced data acquisition and image reconstruction methods to enable QSM of the abdomen. Further, investigators will determine the accuracy, repeatability, and reproducibility of abdominal QSM for iron quantification in patients with liver iron overload. Excessive accumulation of iron in various organs, including the liver, which affects both adult and pediatric populations, is toxic and requires treatment aimed at reducing body iron stores. Accurate assessment of liver iron concentration is critical for the detection and staging of iron overload as well as for longitudinal monitoring during treatment. In summary, this project will develop a novel MRI-based QSM technique designed for the abdomen and will validate it in pediatric and adult patients with liver iron overload. Upon successful validation, QSM will provide accurate, repeatable, and reproducible quantification of LIC based on a fundamental property of tissue.

NCT ID: NCT04631588 Completed - Facial Fine Lines Clinical Trials

Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines

Start date: November 16, 2020
Phase: Phase 1
Study type: Interventional

The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.

NCT ID: NCT04631328 Completed - Family Engagement Clinical Trials

Sesame Street Growing Together Evaluation

Start date: October 31, 2019
Phase: N/A
Study type: Interventional

This study aims to evaluate the appeal and effectiveness of Sesame Workshop's Growing Together online professional development course.

NCT ID: NCT04631185 Completed - Clinical trials for Surgical Site Infection

Surgical Site Infection and Antibiotic Use Study

ASSERT
Start date: May 7, 2021
Phase: N/A
Study type: Interventional

This study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). The patients will be randomly assigned to one of the two treatment groups. One group will receive a single dose of antibiotics just before surgery and if necessary, more doses during the surgery. The other group will receive the same treatment as the first group, along with an additional week of antibiotics after surgery. The study will assess the rates of SSI from the two groups. It will also assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group.

NCT ID: NCT04631107 Completed - Clinical trials for Obstructive Sleep Apnea

AD109 Dose Finding in Mild to Moderate OSA

Start date: December 22, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

NCT ID: NCT04631029 Completed - Clinical trials for Malignant Solid Neoplasm

Testing the Addition of an Anti-cancer Drug, Entinostat, to the Usual Chemotherapy and Immunotherapy Treatment (Atezolizumab, Carboplatin and Etoposide) for Previously Untreated Aggressive Lung Cancer That Has Spread

Start date: April 27, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial seeks to find out the best dose, possible benefits and/or side effects of entinostat in combination with atezolizumab, carboplatin and etoposide for the treatment of previously untreated aggressive lung cancer that has spread (extensive-stage small cell lung cancer). Entinostat and etoposide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is a chemotherapy drug that attaches to deoxyribonucleic acid (DNA) and may kill tumor cells. Giving entinostat in combination with atezolizumab, carboplatin and etoposide may work better than atezolizumab, carboplatin and etoposide alone.

NCT ID: NCT04631016 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis

FRONTIER-4
Start date: December 14, 2020
Phase: Phase 2
Study type: Interventional

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.