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NCT ID: NCT04577404 Completed - Clinical trials for Amyotrophic Lateral Sclerosis (ALS)

Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Start date: October 29, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

NCT ID: NCT04577352 Completed - Friedreich Ataxia Clinical Trials

A Study to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Participants With Friedreich Ataxia

MOVE-FA
Start date: December 17, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy (using the modified Friedreich Ataxia Rating Scale [mFARS]) and safety of vatiquinone in participants with Friedreich ataxia (FA).

NCT ID: NCT04577183 Completed - Diabetic Foot Ulcer Clinical Trials

A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1

Start date: July 11, 2018
Phase: N/A
Study type: Interventional

The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records. All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care

NCT ID: NCT04577118 Completed - Cochlear Implant Clinical Trials

The iotaSOFT Insertion System Safety Study

Start date: September 18, 2020
Phase: N/A
Study type: Interventional

Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.

NCT ID: NCT04576988 Completed - Clinical trials for Pulmonary Arterial Hypertension

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)

Start date: January 25, 2021
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo.

NCT ID: NCT04576962 Completed - Clinical trials for Human Papillomavirus Vaccination

County Level Correlates of HPV Vaccine Series Completion Among Children Ages 11-14 Years in Indiana

Start date: February 9, 2021
Phase:
Study type: Observational

The overall objective is to document geographic variability in HPV vaccine series completion across the state of Indiana and to identify factors associated with low versus high rates of completion. Objective a: To map HPV vaccine series completion rates across Indiana's 92 counties for children aged 14 years and younger. Hypothesis: The investigators expect wide variability in completion rates from county to county. Further, the investigators expect significantly less variability in county-level administration of vaccines required for middle-school entry (Tdap, MenACWY, and HepA vaccines). Objective b: To identify county-level characteristics associated with HPV vaccine series completion rates across Indiana's 92 counties. Hypothesis: The investigators expect factors reflective of pragmatic obstacles to be associated with lower completion rates: such as lower population density, fewer primary health care providers (HCP) per capita, longer commute to work, lower median household income, and lower rates of insurance coverage of children.

NCT ID: NCT04576949 Completed - Smoking Cessation Clinical Trials

A Study of Cytisinicline for Smoking Cessation in Adult Smokers

ORCA-2
Start date: October 13, 2020
Phase: Phase 3
Study type: Interventional

This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks as well as repeating that duration for a total of 84 days/12 weeks treatment.

NCT ID: NCT04576897 Completed - Portal Hypertension Clinical Trials

Velacur by Sonic Incytes for Portal Hypertension

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

This is a cross sectional study that evaluates the relationship between LSM (liver stiffness measurement) by Liver Incytes in patients with cACLD (compensated advanced chronic liver disease) and manifestations of portal hypertension.

NCT ID: NCT04576819 Completed - Sepsis Clinical Trials

Role and Mechanisms of Lipid and Lipoprotein Dysregulation in Sepsis

Start date: November 20, 2020
Phase:
Study type: Observational

Lipids and lipoproteins (cholesterol and lipid metabolites) are present in sepsis and are highly biologically active regulators of inflammation, but currently the changes in lipid and lipoprotein homeostasis during sepsis are not well understood. This project will investigate the changes in lipid and lipoprotein function, oxidation, metabolites, and changes in gene expression to further our understanding of dysregulated lipid and lipoprotein metabolism in sepsis. We will analyze a bank of samples and make associations with important clinical outcomes (early death, chronic critical illness and sepsis recidivism) as supported by our published work, and will confirm our findings in a small prospective cohort of sepsis patients.

NCT ID: NCT04576754 Completed - Clinical trials for Postpartum Depression

Pivotal Test: WB001

Start date: November 12, 2020
Phase: N/A
Study type: Interventional

The purpose of the present randomized controlled study is to investigate if there is a difference in postpartum depression symptoms among participants assigned to : 1. an automated conversational agent based on the most researched and scientifically validated psychotherapies, primarily Cognitive Behavioral Therapy (CBT), and accessible via an iOS and Android application, or to 2. a comparison condition without CBT and conversation, though still delivered in an interactive smartphone application that is accessible anytime of day.