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NCT ID: NCT04948827 Completed - Smoking Cessation Clinical Trials

A First-in-Human Study of SBP-9330 in Healthy Subjects

Start date: July 20, 2021
Phase: Phase 1
Study type: Interventional

This is a single center, first-in-human, randomized, double-blind, placebo-controlled, Single-Ascending Dose (SAD) / Multiple-Ascending Dose (MAD) study incorporating a food-effect cohort.

NCT ID: NCT04948307 Completed - Opioid-use Disorder Clinical Trials

OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder

Start date: June 30, 2021
Phase: N/A
Study type: Interventional

This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patterns in subjects with OUD. Approximately 400 subjects will be randomized. The study will include a screening visit and a randomization visit, followed by 24 weeks of study treatment. Subjects will be scheduled for evaluation visits, which will include a UDS and a self report of drug use, weekly during the first four weeks of treatment, then every other week from weeks 5 through 12, then monthly through week 25. Subjects will also return to the site for only a urine drug screen (UDS) and a self-report of drug use each week between the evaluation visits. The primary objective of the study is to determine whether the combination of sublingual (SL) buprenorphine/naloxone (BUP/NAL) standard of care (SOC) background therapy and the digital therapeutic OXD01 is superior to SL BUP/NAL alone to reduce opioid use.

NCT ID: NCT04948099 Completed - Clinical trials for Dendritic Cell -Mediated Rheumatic Diseases

A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases

Start date: July 6, 2021
Phase: Phase 1
Study type: Interventional

A first-in-human study to evaluate the safety and tolerability of escalating, single and multiple ascending doses of VIB1116 in adult participants with rheumatic diseases.

NCT ID: NCT04947878 Completed - Clinical trials for Musculoskeletal Diseases

Development and Validation of an Orthopedic Visit Prompt List

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

Investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.

NCT ID: NCT04947709 Completed - Clinical trials for Childhood Cancer Survivors

Physical Activity Post-Cancer for Adolescents and Young Adults

PAPAYA
Start date: June 21, 2022
Phase: N/A
Study type: Interventional

The Physical Activity Post-Cancer for Adolescents and Young Adults (PAPAYA) trial aims to carry out a pilot randomized controlled trial among 10-17 year-old adolescents and young adults, at least 1 year and up to 5 years post-cancer treatment. The trial will evaluate the effects of a 12 week physical activity intervention to improve patient reported outcomes and physical function, in comparison to a delayed-intervention control group.

NCT ID: NCT04947514 Completed - Clinical trials for Venous Thromboembolism

Use of Tranexamic Acid in Reduction Mammoplasty

TREX-ARM
Start date: October 29, 2021
Phase: Phase 4
Study type: Interventional

Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic surgery. However, postoperative hematoma is one of the most common complications following BRM. Hematoma-related complications include unplanned surgery, need for blood transfusion, wound healing issues, and unfavorable surgical outcomes. Tranexamic acid has emerged in the literature as a promising agent that reduces perioperative blood loss and need for transfusion. However, despite its consistently reported efficacy, low cost, and favorable safety profile, tranexamic acid remains underutilized in plastic surgery. The investigators propose a prospective, double-blinded randomized controlled study of the efficacy of tranexamic acid in reducing hematoma development in patients undergoing reduction mammoplasty. The investigators hope to contribute to the growing body of literature supporting tranexamic acid to reduce unwanted surgical bleeding.

NCT ID: NCT04947436 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

ALS and Airway Clearance (ALSAC) Therapy

ALSAC
Start date: January 25, 2012
Phase: N/A
Study type: Interventional

Patients will receive one of three respiratory therapy interventions for airway clearance assistance: 1) High frequency chest wall oscillation (HFCWO) and mechanical insufflation/exsufflation (MIE), 2) HFCWO or 3) MIE. The study period will be six months and include three clinic visits, baseline and follow-up visits at 3 and 6 months, and 6 monthly home visits by the respiratory therapist.

NCT ID: NCT04947423 Completed - Motion Sickness Clinical Trials

Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion

Start date: June 14, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, two-arm, randomized, double-blind, placebo-controlled, single dose efficacy and safety study evaluating the use of a nasal gel to prevent nausea and vomiting associated with motion

NCT ID: NCT04947150 Completed - Cancer Clinical Trials

Optimizing an mHealth Intervention to Change Food Purchasing Behaviors for Cancer Prevention

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

Dietary intake is a powerful, modifiable factor that influences cancer risk. Unfortunately, most adults in the U.S. find it difficult to adhere to dietary guidelines for cancer prevention. One promising pathway for improving dietary adherence is to target grocery shopping habits, i.e., foods purchased for consumption at home. Two-thirds of daily food intake is sourced from or eaten in the home, so improving the quality of the home food environment should improve overall diet quality. When healthy foods are purchased and unhealthy foods are not, minimal self-control is needed to make healthy eating choices in the home. At the point of purchase, it is difficult to resist the temptation of palatable foods, but interventions might facilitate healthy choices by promoting dietary goal salience in real-time while grocery shopping, enhancing motivation to make and sustain changes to the diet, and increasing household support and accountability for healthy food purchasing. The proposed study will enroll adults who have low adherence to cancer prevention dietary recommendations. All participants will attend a nutrition education workshop conducted via Zoom. For 20 weeks, all participants also will receive once weekly reminders and recommendations for food purchasing via an app. The study will experimentally test four additional intervention components: location-triggered messages, coaching monitoring of food purchases, benefit of change content, and household member involvement. The preliminary aim of the study is to assess feasibility and acceptability of the intervention components. The primary aim of the study is to quantify the effect of each intervention component, individually and in combination, on dietary intake (assessed with 24-hour food recalls). The overarching goal of this project is to optimize this mHealth intervention, which can be tested in the future in a fully powered clinical trial.

NCT ID: NCT04947124 Completed - Glaucoma Clinical Trials

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101

Start date: October 19, 2021
Phase: Phase 2
Study type: Interventional

Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).