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NCT ID: NCT04768296 Completed - Clinical trials for Small-cell Lung Cancer

Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)

Start date: March 29, 2021
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.

NCT ID: NCT04768114 Completed - Smoking Cessation Clinical Trials

Implementation of Genomics in Substance Use Disorder Treatment

Start date: March 19, 2021
Phase: N/A
Study type: Interventional

Cigarette smoking remains one of the leading causes of preventable death. Effective smoking cessation medications exist but use of these treatments is low, making it difficult for most to quit smoking. Behavioral interventions are needed to engage current smokers in the process of quitting smoking and promote the use of evidence-based cessation medications. At the same time, genetics influences one's smoking behaviors (e.g., how much they smoke, difficulty quitting) and risk of smoking-related diseases, yet these personalized factors have not been included in existing behavioral interventions. Incorporating these individualized factors into smoking cessation interventions may make them more personally engaging and thus motivating for treatment. This study will pilot test a risk communication tool that is personalized to one's genetics and will demonstrate the feasibility of a larger trial to test the effect of this personalized genetically-informed intervention on smoking cessation.

NCT ID: NCT04768036 Completed - Clinical trials for Venous Thromboembolism

A Universal Electronic Health Record-based IMPROVE DD VTE Risk Assessment Model for the Prevention of Thromboembolism in Hospitalized Medically Ill Patients

Start date: December 21, 2020
Phase: N/A
Study type: Interventional

This study will be a multicenter clustered randomized trial of patients in hospitals in which a universal "SMART on FHIR" platform-based EHR-embedded IMPROVE DD VTE clinical prediction rules (CPRs) with electronic order entry has been incorporated into required admission and discharge EHR workflow versus hospitals following UMC for VTE risk assessment of medically ill patients. The patient population will consist of hospitalized, medically ill (non-surgical, non-obstetrical) individuals aged > 60 years.

NCT ID: NCT04767464 Completed - Breast Cancer Clinical Trials

Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups

CC-V
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The Compass Course (CC) is a group intervention designed for individuals with Breast Cancer. Over the course of 8 face-to-face group sessions, the CC is designed to help participants reclaim a sense of self-grounded purpose in daily life, defined as intentional use of time and energy in ways that align with one's values, strengths, and sources of personal meaning (e.g., inner compass) in the moments that compose a day. Because of COVID-19, in-person groups are discouraged and so we need to identify new ways to provide group-based interventions that are feasible and efficacious.

NCT ID: NCT04767347 Completed - Dehydration Clinical Trials

Renal Considerations in the Heat Stress Recommendations

Aim1
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

An epidemic of chronic kidney disease is occurring in laborers who undertake physical work outdoors in hot conditions. The reason for this is unknown, but may be related to kidney dysfunction caused by increases in body temperature and dehydration. The current heat stress recommendations for workers were not developed with regards for kidney health. The purpose of this study is to determine if the current recommendations protect against kidney dysfunction.

NCT ID: NCT04767061 Completed - Heart Failure Clinical Trials

Impact of Beta-blockers on Physical Function in HFpEF

Start date: April 1, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to understand the impact of beta-blockers on physical function in older adults with heart failure. We will achieve this objective by conducting N-of-1 trials. N-of-1 trials are personalized experiments that test different treatment options in an individual patient.

NCT ID: NCT04767035 Completed - Procedural Sedation Clinical Trials

Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine

Start date: December 1, 2020
Phase: Phase 1
Study type: Interventional

A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers

NCT ID: NCT04766931 Completed - Covid19 Clinical Trials

The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection

Start date: March 17, 2021
Phase: Phase 1
Study type: Interventional

This is an adaptive, Phase I/II study in 2 parts: Part 1 is to evaluate the Maximum Tolerable Dose (MTD) , tolerance, safety and pharmacokinetics of FB2001 in healthy subjects; Part 2 is to evaluate the safety, pharmacokinetics and efficacy of FB2001 in patients with moderate to severe COVID-19 disease.

NCT ID: NCT04766892 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT

EMBARK-HFpEF
Start date: March 30, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2a proof-of-concept study to assess safety, tolerability, and preliminary efficacy of mavacamten treatment on biomarker levels in participants with heart failure with preserved ejection fraction (HFpEF) and elevation of NT-proBNP with or without elevation of cTnT. Data from this study will inform future study designs of mavacamten in patients with HFpEF.

NCT ID: NCT04766814 Completed - Atrial Fibrillation Clinical Trials

Epigenetic Analysis of Regulation of the Inflammasome-activating NLRP3 Gene in Monocytes From Atrial Fibrillation Patients and Controls

Start date: October 22, 2021
Phase:
Study type: Observational

The study will analyze blood from volunteers to determine whether there is an underlying epigenetic cause of the inflammation of the heart associated with atrial fibrillation (AF) and its progression with age. Confirming the regions of epigenetic elements associated with upregulation of the inflammatory genes will help the investigators in identifying target sites for developing future therapeutic interventions. The investigators propose to confirm the monocyte-cell type specific DNA methylation profile of NOD-, LRR- and pyrin domain-containing protein 3 (NLRP3) and determine the age-related and AF-related changes in DNA methylation and expression of NLRP3 in monocytes. This study will provide insights into the epigenetic regulation of NLRP3 in young and elderly patients, as well as in AF patients vs. controls which will help in devising methods of modulating NLRP3 expression and decreasing cardiac fibrosis progression.