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NCT ID: NCT05687903 Completed - Narcolepsy Type 1 Clinical Trials

A Study of TAK-861 in Participants With Narcolepsy Type 1

Start date: January 9, 2023
Phase: Phase 2
Study type: Interventional

The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.

NCT ID: NCT05687656 Completed - Diabetic Foot Ulcer Clinical Trials

Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers

Start date: October 6, 2022
Phase: N/A
Study type: Interventional

A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs) Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

NCT ID: NCT05687253 Completed - Surgery Clinical Trials

Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery

Start date: October 25, 2022
Phase: Phase 2
Study type: Interventional

Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).

NCT ID: NCT05687240 Completed - Clinical trials for Cardiometabolic Risk Factors

Heart Focused Movement Effects on Cardiometabolic Risk

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

This study is designed as a two-group parallel randomized controlled trial (N=50) to test effects of 8-weeks of Qigong/Tai Chi (QTC) intervention compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., BMI, waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional regulation, eating behaviors, and cognitive performance).

NCT ID: NCT05687162 Completed - Depression Clinical Trials

SSIs for Mental Health and Loneliness

Start date: December 4, 2022
Phase: N/A
Study type: Interventional

This project includes three studies that explore the effectiveness of brief internet interventions for mental health and loneliness. Study 1: The goal of this clinical trial is to examine if a brief online single-session intervention (SSI) adapted from an evidence-based internet cognitive behavioral therapy can reduce feelings of loneliness in people aged 16 and older who struggle with loneliness. The main question it aims to answer is if a brief SSI is sufficient to meaningfully reduce loneliness compared to an active control. Researchers will test these questions by comparing change in loneliness after 8 weeks between participants randomly assigned to either 1) a 30-minute online SSI for loneliness or 2) a 3-session online intervention for loneliness or 3) an active control SSI. Study 2: The goal of this clinical trial is to examine if an SSI for psychological distress that uses popular online content as its primary form of intervention content can reduce feelings of psychological distress in people aged 16 and older who struggle with psychological distress. The main questions it aims to answer are 1) if curated popular online content can be more effective in supporting people struggling with psychological distress than researcher-created content and 2) if curated popular online content can be more effective in supporting people struggling with psychological distress than un-curated self-selected popular online content. Researchers will test these questions by comparing change in distress after 8 weeks between participants randomly assigned to either 1) 25-minute popular online content-based SSI for distress or 2) an effective 25-minute online SSI for distress with evidence-based researcher-created content or 3) online help-seeking as usual. Study 3: The goal of this clinical trial is to examine if an SSI for loneliness that uses popular online content as its primary form of intervention content can reduce feelings of loneliness in people aged 16 and older who struggle with loneliness. The main questions it aims to answer are 1) if curated popular online content can be more effective in supporting people struggling with loneliness than researcher-created content, 2) if curated popular online content can be more effective in supporting people struggling with psychological distress than an active control, and 3) replicating the comparison in study 1, if a brief SSI is sufficient to meaningfully reduce loneliness compared to an active control. The study will test these questions by comparing change in loneliness after 8 weeks between participants randomly assigned to either 1) a 25-minute popular online content-based SSI for loneliness or 2) a 25-minute online SSI for loneliness with evidence-based researcher-created content or 3) an active control SSI.

NCT ID: NCT05686980 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Adverse Events and How Oral ABBV-552 Capsules Moves Through the Body of Healthy Adult Japanese and Han Chinese Participants

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

This study will assess how safe ABBV-552 is and how ABBV-552 moves through the body of adult healthy Japanese and Han Chinese participants. Adverse Events will be assessed. ABBV-552 is an investigational drug being developed for potential treatment of Alzheimer's disease (AD). Approximately 18 adult healthy Japanese and Han Chinese volunteers will be enrolled in 2 sites in the United States. Japanese participants assigned to Arm 1 will receive ascending doses of ABBV-552 oral capsules once every week for 3 weeks. Han Chinese participants assigned to Arm 2 will receive oral ABBV-552 capsules on Day 1. All participants will be followed for 30 days after their last dose. Participants will be confined for 22 days or 8 days depending on the Arm they are assigned to. Adverse Events and blood tests will be performed.

NCT ID: NCT05686928 Completed - Surgical Wound Clinical Trials

Healing Ointment Usage Post-surgical Procedure

Cetaphil
Start date: August 17, 2022
Phase: Phase 4
Study type: Interventional

To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures

NCT ID: NCT05686421 Completed - Glaucoma Clinical Trials

Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations

Start date: March 30, 2023
Phase: N/A
Study type: Interventional

In this study, participants will be imaged using two Optical Coherence Tomography (OCT) devices: device N, a standard conventional OCT device with an invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device; and device C, the standard conventional OCT device with no invention attached. The investigators will assess whether the chin and forehead rest attachment (invention) provides a more comfortable experience for patients.

NCT ID: NCT05686408 Completed - Depression Clinical Trials

Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

UPLIFT
Start date: March 2, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).

NCT ID: NCT05686369 Completed - Celiac Disease Clinical Trials

A Decentralized Home-Based Study To Investigate Novel Objective Biomarker Of Gluten-Mediated Symptoms In Celiac Disease Participants (CeDar ROSE Study)

Start date: March 8, 2023
Phase:
Study type: Observational

This is a decentralized study to primarily explore a novel objective digital biomarker (i.e., Gluten Dependency Index) for celiac disease-related responses triggered by gluten exposure using a wearable biosensor. This study also explores a novel objective blood biomarker specific to celiac disease activity and evaluates participant symptoms, lifestyle and an objective comprehensive measurement (e.g., activity, stress and sleep) in celiac disease participants. Approximately 170 well-controlled celiac disease participants (Cohort A) and 40 celiac disease participants with persistent symptoms (Cohort B) will be monitored for 13 and 8 weeks in the observation period, respectively, in a home-based setting using the wearable biosensor along with a mobile platform including some electronic questionnaires. The wearable biosensor continuously records biosensor data. These data will be used to develop a new algorithm for Gluten Dependency Index and calculate the Gluten Dependency Index, Activity Value, Stress Value, or Sleep Time. Participants will report celiac disease-related symptoms, diet (including any accidental gluten exposures), exercise, menstruation questionnaires in CDSD and mobile platform questionnaire (MPFQ), which is originally designed by the Sponsor. All participants both in Cohort A and B are required to maintain gluten-free diet throughout the study. Only participant who are enrolled in Cohort A will be required gluten challenge.