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NCT ID: NCT05136820 Active, not recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction (HFpEF)

Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study

FROST-HF
Start date: March 9, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to assess the safety and effectiveness of the Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) while on stable guideline directed medical therapy (GDMT) as outlined in the Guidelines for the Management of Heart Failure.

NCT ID: NCT05136430 Active, not recruiting - Obesity Clinical Trials

A Multiple Health Behavior Change Intervention for Overweight and Obese Smokers

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

The purpose of this study is to determine the efficacy, acceptability, and feasibility of an intervention that provides a behavioral weight gain prevention intervention in advance of smoking cessation treatment in individuals with overweight or obesity who smoke cigarettes. The primary aim of this study is to determine feasibility and acceptability and initial efficacy regarding whether preceding 8 weeks of smoking cessation treatment with 8 weeks of self-regulation strategies + large changes for weight gain prevention (SR), compared to 8 weeks of healthy lifestyle education (LE), will result in greater smoking cessation and reduced weight gain. Secondary aims are to study effects on self-efficacy for managing weight and for quitting smoking, negative affect, and delayed reward discounting. Methods: Individuals with overweight or obesity who smoke cigarettes will participate in a 16-week group-based multiple health behavior change intervention. Groups will be randomly assigned to receive either 8 weeks of SR followed by 8 weeks of smoking cessation treatment or 8 weeks of LE followed by 8 weeks of smoking cessation treatment. Smoking cessation treatment in both conditions will include counseling and combination nicotine replacement therapy (patch + lozenges), with a quit day at week 9 of the 16-week intervention. Assessments will occur at baseline, on quit day and 1, 2, and 3 months later. Determining the viability of this strategy in terms of effects on both smoking and weight has high significance to public health.

NCT ID: NCT05136339 Active, not recruiting - Weight Loss Clinical Trials

Healthy Immigrant Community: Mobilizing the Power of Social Networks

Start date: April 23, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast, Minnesota.

NCT ID: NCT05135910 Active, not recruiting - Clinical trials for Onychomycosis of Toenail

To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis

Start date: January 13, 2022
Phase: Phase 2
Study type: Interventional

The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO).

NCT ID: NCT05135767 Active, not recruiting - Clinical trials for Alcohol Use Disorder

Biobehavioral Pathways Underlying Alcohol Use and Health

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

Alcohol-associated liver disease (ALD) and alcohol use disorder (AUD) are intersecting diseases that add substantially to the global burden of disease and mortality. ALD refers to a spectrum of liver tissue injury caused by chronic and excessive alcohol use. Although reducing drinking is a main treatment goal, this is often unachievable for many patients with ALD due to an underlying AUD characterized by alcohol craving and drinking despite harms. While numerous, high-quality studies demonstrate effectiveness of brief psychosocial interventions for AUD, few trials have tested the efficacy of psychosocial interventions to reduce drinking in individuals with or at risk for ALD. This project establishes a team of addiction scientists and hepatologists to form a partnership and support future collaboration.

NCT ID: NCT05135260 Active, not recruiting - Cancer Clinical Trials

Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic

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

This study will investigate the ability of virtual reality to function as a novel distraction intervention and improve the experience of patients who are receiving chemotherapy in the infusion clinic.

NCT ID: NCT05135234 Active, not recruiting - Sedentary Lifestyle Clinical Trials

Developing a Physiological Understanding of High Duration Activity

Start date: August 2016
Phase: N/A
Study type: Interventional

When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. This sedentary behavior is associated with elevated risk of diabetes, cardiovascular diseases, some cancers, and multiple conditions leading to poor aging. From a progressive series of experiments, the driving goal is to develop a physiological method for sustaining contractile activity via oxidative metabolism over more time than is possible by traditional exercise (hours, not minutes per day). Developing a physiological method suitable of prolonged muscular activity for ordinary people (who are often unfit) requires gaining fundamental insights about muscle biology and biomechanics. This also entails a careful appreciation of the ability to isolate specific muscles in the leg during controlled movements, such as the soleus muscle during isolated plantarflexion. This includes quantifying specific biological processes that are directly responsive to elevated skeletal muscle recruitment. The investigators will focus on movement that is safe and practical for ordinary people to do given their high amount of daily sitting time. This includes developing methods to optimally raise muscle contractile activity, in a way that is not limited by fatigue, and is feasible throughout as many minutes of the day as possible safely. This also requires development of methodologies to quantify specific muscular activity, rather than generalized body movement. There is a need to learn how much people can increase muscle metabolism by physical activity that is perceived to them as being light effort. It is important to learn if this impacts systemic metabolic processes under experimental conditions over a short term time span in order to avoid confounding influences of changes in body weight or other factors.

NCT ID: NCT05135169 Active, not recruiting - Healthy Clinical Trials

Multi-organ Transit Time Acquisition Using Contrast Ultrasound

Start date: March 3, 2022
Phase:
Study type: Observational

Echocardiographic contrast will be administered to volunteers for the purpose of measuring transit time through various organs/vascular beds

NCT ID: NCT05133336 Active, not recruiting - Clinical trials for Primary Biliary Cholangitis

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

EPICS-III
Start date: April 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)

NCT ID: NCT05132907 Active, not recruiting - SARS-CoV2 Infection Clinical Trials

Safety And Immunogenicity Of HDT-301 Targeting A SARS-CoV-2 Variant Spike Protein

Start date: January 24, 2022
Phase: Phase 1
Study type: Interventional

This is Phase 1 study is to assess tolerability and immunogenicity of three dose levels of the investigational HDT-301 vaccine administered intramuscularly (IM), both in immunization-naïve participants and as a booster for those participants who previously received a SARS-CoV-2 vaccine. Safety and tolerability will be the primary endpoint assessed by incidence of adverse events at each dose through 12 months after completion of the vaccination regimen (either one dose, or two doses provided 56 days apart). Immunogenicity evaluations will be conducted for pre-specified timepoints as secondary and exploratory endpoints.