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NCT ID: NCT05995574 Not yet recruiting - Communication Clinical Trials

Adolescent Contraception: Communication Training Intervention to Engage Pediatrician-Adolescent-Mother Triads

Start date: April 1, 2025
Phase: N/A
Study type: Interventional

In order to support the desire of most adolescents to delay pregnancy (parenting) until their own adulthood, pediatricians must be comfortable and skilled in having reproductive health conversations with adolescents and the mothers of adolescents. Artificial intelligence, such as a chatbot, could be programmed to simulate the perspective of the mother or the daughter as a tool for pediatricians to practice communication before interacting with "real" families. Through human-centered design, an iterative problem-solving approach, our overall goal is to develop and test a communication training chatbot tool that is accurate, developmentally tailored for adolescents and mothers, culturally tailored, and aids pediatricians to manage resistance and conflict about contraception to ultimately close disparities in teen births. The investigator's primary hypothesis is that a communication focused intervention will improve pediatrician interactions with dyads about contraception. Through three stages, the study team will develop an artificial intelligence tool as a behavioral intervention. The study team will gather basic communication data to generate, refine, modify, adapt, and pilot test novel communication tools with real-world encounters while keeping humans at the center of attention

NCT ID: NCT05995535 Recruiting - Opioid Use Clinical Trials

Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

UH3
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.

NCT ID: NCT05995496 Recruiting - Bulimia Nervosa Clinical Trials

Changes in Inhibition and Valuation After Eating

Start date: December 12, 2023
Phase: N/A
Study type: Interventional

An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.

NCT ID: NCT05995444 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects

Start date: June 5, 2023
Phase: Phase 1
Study type: Interventional

A single-center, 4-way crossover study to evaluate the effect of single therapeutic and supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.

NCT ID: NCT05995405 Recruiting - Clinical trials for Aneurysmal Subarachnoid Hemorrhage (aSAH)

Safety and Tolerability of GTX-104 Compared With Oral Nimodipine in Patients With aSAH

STRIVE-ON
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to deliver nimodipine via IV directly into the bloodstream and to determine if this is as safe and tolerable as oral nimodipine capsules.

NCT ID: NCT05995392 Not yet recruiting - Dry Eye Disease Clinical Trials

The Effects and Safety of Topical Spironolactone Ophthalmic Solution, 0.005 mg/cc in Subjects With Dry Eye Disease

Start date: August 2023
Phase: Early Phase 1
Study type: Interventional

The objective of this study is to evaluate the clinical efficacy of topical spironolactone ophthalmic solution, 0.005 mg/cc in subjects with dry eye disease compared to placebo. The hypothesis for this study is that topical spironolactone ophthalmic solution will be beneficial in the management of signs and symptoms of dry eye disease when compared to placebo.

NCT ID: NCT05995366 Completed - Healthy Volunteer Clinical Trials

A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration

Start date: August 18, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the mass balance and safety of [14C] ABBV-903 in healthy male volunteers following a single oral dose administration.

NCT ID: NCT05995353 Recruiting - Crohn's Disease Clinical Trials

A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease

Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to < 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 110 pediatric participants with CD will be enrolled at around 100 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05995262 Active, not recruiting - Diabetes Clinical Trials

Effect of a Pharmacist-led, Collaborative Practice on Clinical Outcomes in Persons With Diabetes

Start date: April 6, 2023
Phase:
Study type: Observational

Diabetes is a complex chronic illness known for its high prevalence (11.3% in the United States), significant healthcare burdens in terms of cost and management, and high mortality rate (seventh leading cause of death in the United States in 2019). Diabetes-related complications including ischemic heart disease, stroke, hyperglycemic crises, amputations, and hypoglycemia accounted for 8.25 million hospital discharges and 25.9% of emergency department visits, contributing towards the $327 billion total cost of diabetes in 2017. Proper treatment of diabetes is integral to reduce a patient's risk of developing complications; however, a number of barriers can create additional burdens for persons with diabetes. Several studies have also demonstrated reductions in hospitalizations and/or ED visits for patients enrolled in pharmacist-led collaborative practice models. While the literature as a whole clearly describes the impact of ambulatory pharmacist intervention in achieving guideline-based clinical goals (i.e., HbA1c, blood pressure), few studies have reported on adherence with guideline-driven pharmacotherapy pre- and post-pharmacist intervention, or on pharmacist impact in reducing medication burden.

NCT ID: NCT05995249 Completed - Healthy Volunteers Clinical Trials

A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults

Start date: August 11, 2023
Phase: Phase 1
Study type: Interventional

The main aim of this study is to find out how the body of a healthy adult processes TAK-279 (pharmacokinetics) when substances that either hinder or help the human metabolism such as erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn about side effects and how well it is tolerated when TAK-279 is given alone and together with substances that impact human metabolism. The participants will need to stay at the clinic for up to 26 days.