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NCT ID: NCT05478551 Active, not recruiting - Scar Clinical Trials

Randomized Controlled Trial Examining the Efficacy of Botulinum Toxin in Biopsy Scar Minimization

Start date: June 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The proposed study seeks to evaluate the scar reduction capacity of BTA on excision/biopsy wounds compared to the control (normal saline) in a double-blinded randomized control trial. It will expand upon previous studies that have already demonstrated the safety and good tolerance profile of BTA. We will be conducting a split-scar study/study involving two biopsy sites in a singular patient, allowing them to serve as their own control. In keeping with the results from previously conducted studies, we hypothesize that the wounds treated with BTA will have significantly less evidence of scar formation than those sites treated with normal saline.

NCT ID: NCT05478499 Active, not recruiting - Psoriasis Clinical Trials

Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Start date: October 6, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

NCT ID: NCT05477706 Active, not recruiting - Depression Clinical Trials

Peer Intervention to Improve Access Among Rural Women Veterans With Psychological Distress and Unmet Social Needs

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

This research project will refine and evaluate delivery of a peer-delivered evidence-based intervention to improve perceived access and actual engagement with mental health treatment and social resource service use among rural women Veterans, especially Veterans of color, with psychological distress and unmet social needs.

NCT ID: NCT05477576 Active, not recruiting - Clinical trials for Neuroendocrine Tumors

Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

ACTION-1
Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.

NCT ID: NCT05477524 Active, not recruiting - Lyme Disease Clinical Trials

An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)

VALOR
Start date: August 4, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence. Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months after end of primary vaccination series. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. A subset of participants will be followed for a third Lyme disease season. Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective. If enrolled, participants will need to visit the research site at least 7 times during the study, and for a subset of participants up to 9 times. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years. The subset of participants followed for a third Lyme disease season will take part in this study for up to about to 3 and a half years.

NCT ID: NCT05477147 Active, not recruiting - Atrial Fibrillation Clinical Trials

Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion

RESTART
Start date: March 17, 2023
Phase: N/A
Study type: Interventional

Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation.

NCT ID: NCT05476783 Active, not recruiting - Alzheimer's Disease Clinical Trials

A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease

Start date: September 14, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label long term extension study for participants with Alzheimer's disease (AD) who have completed Protocol TB006AD2102 (lead-in study) or participants who would have been eligible for the lead-in study but were not enrolled (de novo). The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TB006. The total study duration for each participant will be up to 113 weeks.

NCT ID: NCT05473182 Active, not recruiting - Cerebral Palsy Clinical Trials

IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

Power wheelchairs (PWCs) offer children who are unable to independently opportunities for participation in social, educational, and leisure activities. Unfortunately, children who have severe cognitive, motor, or sensory impairments may need extended training to be able to master the PWC skills needed to "qualify" for their own PWC. The IndieTrainer system was developed to address this need. The IndieTrainer system is comprised of the IndieGo device and video-game modules. The IndieGo device temporarily converts a manual wheelchair into a powered wheelchair, thereby allowing children to remain in their own manual wheelchair and use their own custom seating system during power wheelchair skills training activities. The video-game modules are integrated into the IndieGo device such that the video games can be played on a TV screen using the specific access method used to control the IndieGo (i.e., switch or joystick). The IndieTrainer system is designed to allow a child to practice power wheelchair skills as part of the video-game modules or as part of more traditional power wheelchair skills training activities wherein children are able to actively explore the environment and practice executing actual wheelchair skills. This study will evaluate the use of the IndieTrainer system in children with cerebral palsy, ages 5-21 years.

NCT ID: NCT05472831 Active, not recruiting - Clinical trials for Cognitive Function 1, Social

Optimizing Cognition Via Exercise and Nutrition

OCEAN
Start date: August 15, 2022
Phase: N/A
Study type: Interventional

Investigators propose to test the preliminary efficacy of the refined BAILAMOS™ Latin dance program plus a culturally tailored MIND diet (Mediterranean-DASH diet intervention for neurodegenerative delay) program on cognitive function among older Latinos (ages 50+) at risk of cognitive decline. This project will test whether participants randomized to the BAILAMOS™ Latin dance plus MIND diet experience better cognitive outcomes than participants randomized to the BAILAMOS™ Latin dance plus a health education program.

NCT ID: NCT05472688 Active, not recruiting - Dysbiosis Clinical Trials

My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)

Start date: July 14, 2022
Phase:
Study type: Observational [Patient Registry]

My Baby Biome is an observational study that will use 600 infant stool samples to determine the biomarkers associated with a healthy infant gut. Biomarkers identified in this study will be used to develop precision probiotics and LBPs for improving infant gut health outcomes to the benefit of all infants. Parents will be asked to submit follow-up questionnaires regarding infant immune health to improve insights obtained from the data.