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NCT ID: NCT05359575 Completed - Clinical trials for Cervical Vertebra Injury

Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

It is not known if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for c-spine immobilization. Therefore, POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design.

NCT ID: NCT05359328 Completed - Hypoxia Clinical Trials

RDS MultiSense® SpO2 Validation Study

Start date: April 26, 2022
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to arterial blood samples assessed by measuring carbon monoxide (CO) bound to hemoglobin by CO-Oximetry. Additionally, data will be collected for heart rate accuracy as compared to reference ECG. The end goal is to provide supporting documentation for the SpO2 and heart rate accuracy validation for RDS MultiSense® Pulse Oximetry. A minimum of 10 healthy adult male and female participants, ranging in age and pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by International Organization for Standardization ISO 80601-2-61:2017: corrected version 2018-02 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The investigational device will be placed on the placed on the thorax of the participants (patch on the upper back and external electrode on the right pectoral) per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.

NCT ID: NCT05358860 Completed - Clinical trials for Acne Scars - Mixed Atrophic and Hypertrophic

Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

NCT ID: NCT05358847 Completed - Cellulite Clinical Trials

Treatment for Cellulite Appearance

Start date: November 21, 2021
Phase: N/A
Study type: Interventional

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

NCT ID: NCT05358821 Completed - Huntington Disease Clinical Trials

28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease

Start date: June 22, 2022
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess the magnitude of the baseline difference between participants with early Huntington's Disease (HD) and healthy participants (HP) with respect to measures of cognitive performance.

NCT ID: NCT05358756 Completed - Healthy Subject Clinical Trials

A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers

Start date: October 9, 2021
Phase: Phase 1
Study type: Interventional

This was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet.

NCT ID: NCT05358522 Completed - Surgery Clinical Trials

Increasing Implementation of Post-Operative Opioid Prescribing Guidelines

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The objective of this research study is to evaluate the effect of a quality improvement initiative carried out by a health system opioid stewardship task force aiming to increase clinician post-operative prescribing adherence with procedure specific guidelines that were developed using patient reported data. The feedback compares the clinician's average number of opioid pills prescribed after a given procedure to other clinicians in the health system and to the health system guideline recommended amount based on patient reported data on opioid pills taken for that procedure. The feedback also provides historical data on mean patient reported number opioid pills taken following a given procedure and on patients' ability to manage pain among those who received guideline adherent prescriptions compared with patients who received greater than the guideline recommended amount.

NCT ID: NCT05358444 Completed - Type 2 Diabetes Clinical Trials

Family Diabetes Prevention Program Pilot Study

Start date: July 8, 2022
Phase: N/A
Study type: Interventional

This study will examine the feasibility and acceptability of a family-oriented augmentation of the Diabetes Prevention Program lifestyle intervention (DPP), called the Family DPP. It will also preliminarily examine adult and child health and health behavior outcomes. The DPP is a 12-month, group-based lifestyle intervention for adults at high-risk for type 2 diabetes, in which adult participants learn skills and strategies to achieve the program's goals of 5% weight loss and 150 minutes/week of moderate-vigorous physical activity. The Family DPP will consist of all elements of the evidence-based DPP, along with augmentations including additional child-focused sessions in which adult participants will learn about principles and strategies for promoting healthy lifestyle behaviors in children, ages 5 through 12 years. Children may participate in certain child-focused sessions, too. The non-randomized pilot feasibility study will consists of 2 arms/groups: 1) the concurrent "control" group, consisting of adults who are enrolled in the DPP; and 2) the "intervention" arm, in which the adult participants will engage in the Family DPP (and children may participate in certain aspects of the Family DPP focused on children). The study will recruit 10-15 adult-child dyads, for the "intervention" groups, and 10-15 adults for the concurrent control group. In addition to data collected from adult participants as a routine part of the DPP, the study will examine additional adult health behaviors and health outcomes and child health outcomes (change in body mass index z-score) and health behaviors at baseline, 6 months and 12 months (program end) among participants in the "intervention" group.

NCT ID: NCT05358366 Completed - HIV Infections Clinical Trials

Love Infection: A Dramatized Story Intervention (Telenovela/Soap Opera) for HIV Prevention

IA
Start date: May 10, 2022
Phase: N/A
Study type: Interventional

Purpose: To test the feasibility, acceptability of the IA intervention (four telenovela episodes), assessment of the mechanisms of action (self-efficacy, narrative engagement, and emotional elicitation) and conduct a randomized controlled pilot study to examine the change in primary outcomes (condom use, HIV testing, Pre-exposure Prophylaxis (PrEP) awareness and use) and secondary outcomes (Substance abuse (SA), intimate partner violence (IPV), and depression comparing 33 intervention- and 33 control Latinas at baseline (T1, pre-intervention), T2 (immediately post-intervention, 1 month) and T3 (3 months after the end of the intervention, with no intervening contact with study staff). Participants: 66 Latinas ages 18-44 years who report sexual activity with a man in the last 6 months, have internet access from any device, and reside in NC. Procedures (methods): Participants will be asked to: (1) receive an orientation about the use of the Infección de Amor (IA) telenovela website and access the telenovela website once a week for 4 weeks to watch a telenovela episode and answer some questions about the episode (half hour each week, 2 in total), (2) attend to a one hour-meeting with the research team to complete a baseline survey, (3) complete a survey (on their own) one-month after the baseline survey, and (4) complete another survey (on their own) 4-months after the baseline survey. Participants will complete a structured survey in the first meeting (baseline survey) with a member of the research team and then they will complete the follow-up surveys (1-month and 4-months after baseline) on their own. Participants can request help to complete these surveys with the help of the research team (online using Zoom or face to face if needed). The moment that participants will access the IA intervention will depend on the group to be assigned by the research team (intervention or control group).

NCT ID: NCT05358327 Completed - Lax Skin Clinical Trials

Treatment for Lifting Upper Arm Lax Skin

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.