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NCT ID: NCT05824143 Completed - Clinical trials for Healthy Participants

Open-label Trial to Evaluate the Effect Carbamazepine on Darigabat Pharmacokinetics in Healthy Adult Participants

Start date: April 17, 2023
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to evaluate the effect of increased metabolizing enzyme (cytochrome P450 [CYP] 3A4) due to carbamazepine, a strong CYP3A4 inducer, on the pharmacokinetics (PK) of darigabat in healthy adult participants.

NCT ID: NCT05823948 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)

ONWARDS 9
Start date: April 11, 2023
Phase: Phase 3
Study type: Interventional

This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor (a small sensor inserted under the skin to measure blood sugar all the time). The study will look at how well insulin icodec controls blood sugar when used in combination with a flash glucose monitor. Participants will get insulin icodec that they have to inject once a week on the same day of the week. The insulin will be injected with a needle in a skin fold in the thigh, upper arm, or stomach. The study will last for about 8 months. Participants will have to wear a flash glucose monitor throughout the study. This is a sensor that fits on arm. Participants will be asked to use a commercially available app called LibreView to allow team to view flash glucose monitor data. Participants will get a study phone to scan the flash glucose monitor 4 times daily and they will be able to see all of the flash glucose monitor data during the study. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

NCT ID: NCT05823597 Completed - Clinical trials for Dietary Added Sugar Consumption

Reducing Dietary Added-Sugar Consumption During the Transition to College

ASUsugarLIA
Start date: September 8, 2020
Phase: N/A
Study type: Interventional

The goal of this cluster randomized controlled trial was to compare the effects of two single-session interventions (sugar-intensive vs. general health control) on added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar 6 weeks later, in a sample of first-semester undergraduates.

NCT ID: NCT05823090 Completed - Depression Clinical Trials

Light Therapy for Depression in Adolescent Outpatients

Start date: December 21, 2021
Phase: Phase 4
Study type: Interventional

The goal of this placebo lead-in clinical trial was to test bright light therapy (BLT) in adolescents with depression. The main question[s] it aimed to answer were: 1. characterize and define facilitators/barriers to treatment with BLT in adolescents); 2. evaluate the acceptability and feasibility of outpatient BLT in a dose titration protocol; 3. establish an effective, safe and tolerable light dose.

NCT ID: NCT05822973 Completed - Knee Arthroscopy Clinical Trials

Sutures for Treatment of Knee Arthroscopy

Start date: November 18, 2018
Phase: N/A
Study type: Interventional

For a knee arthroscopy, two small incisions are made at the level of the joint line on each side of the patellar tendon. Closure of surgical incisions consists of using either nonabsorbable or absorbable sutures. Some surgeons prefer using nonabsorbable sutures due to it being easier to tie, these sutures are less likely to break prematurely, and that they elicit a minimal inflammatory response. On the other hand, some surgeons prefer using absorbable sutures due to the time savings of not having to remove the sutures at a later date and that these sutures decrease patient anxiety and discomfort. The purpose of this study is to prospectively investigate and compare patient's pain, swelling and cosmesis following knee arthroscopy surgery between patients who had their arthroscopy portals closed using resorbable sutures vs. patients who had their portals closed using nonabsorbable sutures.

NCT ID: NCT05822921 Completed - Clinical trials for Autism Spectrum Disorder

Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia

Start date: July 17, 2019
Phase: N/A
Study type: Interventional

This study will be the pilot/feasibility phase of a future clinical trial. The proposed feasibility and pilot study aims to bridge the barriers to diagnosis by providing easy-to-access assessment for free, through a mobile unit that travels to rural locations and telehealth assessments. The diagnostic evaluation will confirm or rule out a diagnosis of ASD, followed by purposeful ASD psychoeducation for parents whose children are diagnosed. Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) or are suspected to have ASD will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials). Parents will complete outcome measures related to their satisfaction, empowerment, and autism spectrum disorder knowledge. Changes in empowerment and ASD knowledge from pre- to post- psychoeducation will be measured using t-tests. The investigators will also track if participants sought and/or received additional ASD-related services throughout the study up to 6-months post-psychoeducation. Results from this study will help to guide a future, fully powered efficacy trial with a larger sample. Added April 2020: In light of the Virginia governor's stay-at-home order in response to the COVID-19 outbreak, the investigators are altering the protocol in line with the university's request to move to remote conduct of research where possible as well as to continue to provide services to families in this time, in line with Executive Order 53 from the VA Governor. Parents in the latter half of the study conducted entirely remotely, will be randomized into the two psychoeducation conditions, telehealth or paper materials psychoeducation groups, as in-person visits are not permitted. Statistical analyses will be added to compare results between and within those who received in-person versus telehealth assessments. The investigators and participants may return to in-person assessments if and when it is possible to do so, but reserve the right to continue tele-assessment even once stay-at-home orders are lifted, in order to fully answer the research aim of the feasibility and validity or tele-assessment procedures in ASD.

NCT ID: NCT05822648 Completed - Type 2 Diabetes Clinical Trials

Evaluating a Type 2 Diabetes Prevention Program

Start date: April 15, 2023
Phase: N/A
Study type: Interventional

This study aims to test the effectiveness of a Type 2 Diabetes (T2D) prevention program for individuals who have been diagnosed with prediabetes compared to a T2D educational control group. Project health is an obesity prevention program and has produced a 42% to 53% reduction in future onset of overweight/obesity and also produced greater reductions in negative affect compared to assessment-only controls that persisted. Project Health has been adapted to prevent onset of T2D among individuals with prediabetes. The study aims to test the effectiveness of Project Health at reducing BMI, HbA1c levels, increase physical activity and improve glucose control.

NCT ID: NCT05822440 Completed - Healthy Clinical Trials

A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.

Start date: April 13, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn how Itraconazole affects the blood level of PF-07817883 in Healthy Adults. This study is seeking participants who are: - male and female aged 18 to 65 years old, - overtly healthy. This can be determined my medical evaluation, medical history, lab tests etc. This study will consist of 2 parts, Period 1 and Period 2. Period 1: participants will take PF-07817883 one time by mouth at the study clinic. Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will also take daily itraconazole by mouth for 7 days. Participants will stay at the study clinic for 2 weeks in total. The study doctors will collect blood and urine samples from everyone. The study doctors will check participants' reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35 days from the last dose of PF-07817883. Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some medicines, it affects the actual level of these medicines in the body. This study will compare blood levels of PF-07817883 given with and without Itraconazole. This will help decide safety and right amount for PF-07817883 when given with metabolism inhibitors.

NCT ID: NCT05822206 Completed - Trauma Clinical Trials

Trauma Informed Intervention to Support Engagement in HIV Care Among MSM (THRIVE+)

THRIVE+
Start date: August 3, 2016
Phase: N/A
Study type: Interventional

This purpose of this project is to specify and provide an initial test of a 10 session, individual-based cognitive therapy intervention to address symptoms of PTSD and poor engagement in HIV care among men who have sex with men (MSM) with trauma histories

NCT ID: NCT05821842 Completed - Clinical trials for Nasal Congestion and Inflammations

Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion

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

To demonstrate the safety and effectiveness of Sonu for the treatment of patients suffering from moderate to severe nasal congestion.