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NCT ID: NCT05540080 Completed - Fat Burn Clinical Trials

Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen

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

This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in subcutaneous fat and muscle tissue in the lateral abdomen region (also referred to as flanks or "love handles"). The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.

NCT ID: NCT05539976 Completed - Clinical trials for Healthy Participants

A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants

Start date: September 30, 2022
Phase:
Study type: Observational

The purpose of this study is to develop taste profiles of iberdomide and mezigdomide drug substances and oral formulation prototypes in order to develop a pediatric oral form of iberdomide and mezigdomide.

NCT ID: NCT05539872 Completed - Pharmacokinetics Clinical Trials

Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers

Start date: August 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.

NCT ID: NCT05539612 Completed - Clinical trials for Respiratory and Pulse Rate Accuracy Validation

Binah.ai Visual Vitals Application - Validation Study

Start date: July 18, 2022
Phase:
Study type: Observational

The purpose of this study is to conduct a Respiratory and Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda), and a standard ECG reference (respectively).

NCT ID: NCT05539443 Completed - Clinical trials for Hypertension Secondary

Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

TEAMS-BP
Start date: October 11, 2022
Phase: N/A
Study type: Interventional

TEAMS-BP is a multicenter, participant-randomized controlled trial designed to compare the effectiveness of Intensive Tailored Telehealth Monitoring (ITTM) versus Intensive Clinic Management (ICM) on Blood Pressure (BP) control and patient activation for BP management following stroke

NCT ID: NCT05539326 Completed - Clinical trials for Osteoarthritis, Knee

A Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension

Start date: December 29, 2022
Phase:
Study type: Observational

The purpose of this study is to determine the construct validity of the Canary Tibial Extension's measure of self-selected community walking speed. Construct validity will be assessed by the Pearson's correlation coefficient between self-selected community walking speed and the 4-meter walk test. The objective of this multicenter, prospective study is to demonstrate that remote measurement of community walking speed with the Canary canturioTM (CTE) tibial extension is correlated with the fast 4-meter walk test (4mWT).

NCT ID: NCT05538754 Completed - Myopia Clinical Trials

Post-Market Evaluation of the EVO ICL

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

The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).

NCT ID: NCT05538728 Completed - Clinical trials for Wrinkles in Decolletage

An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area

Start date: August 31, 2022
Phase: N/A
Study type: Interventional

This is a prospective open-label study to evaluate safety and effectiveness of two different reconstitution volumes of poly-l-lactic acid (PLLA) for correction of wrinkles in the décolletage area.

NCT ID: NCT05538585 Completed - Healthy Volunteers Clinical Trials

A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor

M23-492 FE
Start date: September 27, 2022
Phase: Phase 1
Study type: Interventional

Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The objectives of this study are to assess the effect of food on the safety and pharmacokinetics of navocaftor and galicaftor.

NCT ID: NCT05537961 Completed - Substance Use Clinical Trials

Impact of Mindfulness Training on Adolescent Well-Being and Behavior

Start date: January 13, 2022
Phase: N/A
Study type: Interventional

There is a broad consensus that preventing or delaying initiation of adolescent alcohol, tobacco, and other drug (ATOD) use can substantially improve both short- and long-term adolescent health. Despite the existence of effective prevention programs, adolescent ATOD use continues to be a substantial issue. Continued research on preventive interventions is needed. School-based mindfulness-based interventions (MBIs) have been shown to be feasible and effective at improving adolescent psychological well-being. Evidence from both quasi-experimental studies and randomized controlled trials suggests that incorporating MBIs into school-settings can lower levels of anxiety, depression, and stress, while improving capacity for emotional regulation. Greater mindfulness also been linked to reduced adolescent ATOD use via observational studies. There are strong theoretical reasons to believe that MBIs delivered in school settings can prevent or reduce ATOD use among youth. In particular, MBIs have been shown to improve psychological well-being among youth via multiple mechanisms also relevant for adolescent ATOD use. These mechanisms include enhanced attentional control, negative emotion regulation, promotion of positive emotion generation, and increased feelings of connectedness. Despite these connections, school-based MBIs are yet to demonstrate the ability to prevent or reduce adolescent ATOD use. The current study will examine psychological well-being and ATOD use among approximately 80 participants in a quasi-experimental, school-based MBI. In early 2022, approximately 40 high school seniors were provided with one semester of a weekly, classroom-based MBI embedded into their Social Studies curriculum; approximately 40 high school seniors participated in the standard curriculum. The intervention group was provided with an adaptation of Mindfulness-Oriented Recovery Enhancement (MORE). MORE is an evidence-based therapeutic program that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to treat addiction and enhance well-being. MORE has been shown to produce therapeutic benefits in the treatment of alcohol, tobacco, and other drug addiction in adult populations, but is yet to be tested as a preventive intervention for youth. Follow up data collection is planned for spring 2023 to assess psychological well-being, ATOD use, and proposed therapeutic mechanisms pre-intervention, post-intervention, and at 9-month follow up.