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NCT ID: NCT05720819 Completed - Virtual Reality Clinical Trials

Biofeedback-VR for Treatment of Chronic Migraine

Start date: September 9, 2020
Phase: N/A
Study type: Interventional

Migraine is a common, debilitating neurologic condition affecting more than 900 million individuals worldwide. Established treatments for migraine include medications, vitamin and herbal supplements, neuromodulation, and behavioral treatment strategies. This study aims to determine whether a novel, home-based behavioral approach, combined biofeedback-virtual reality therapy, can improve self-reported migraine-related outcomes in individuals living with chronic migraine. In this randomized, controlled pilot study, 50 adults with chronic migraine are randomized to the experimental group (frequent use of a heart rate variability biofeedback-virtual reality device plus standard medical care; n=25) or wait-list control group (standard medical care alone; n=25). The primary outcome is reduction in mean monthly headache days between groups at 12 weeks. Secondary outcomes include mean change in acute analgesic use frequency, depression, migraine-related disability, stress, insomnia, and catastrophizing between groups at 12 weeks. Tertiary outcomes include change in heart rate variability and device-related user experience measures.

NCT ID: NCT05720767 Completed - Clinical trials for Relapsed or Refractory Lymphoma

HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study

Start date: November 4, 2022
Phase: Phase 1
Study type: Interventional

A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, a CYP3A and P-glycoprotein Inhibitor, and the Effect of Rifampin, a CYP Enzyme Inducer, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers

NCT ID: NCT05720741 Completed - Depression Clinical Trials

Project THINK: Trial of a Brief Cognitive Restructuring Intervention

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This project will involve testing a brief (~30 minute) digital intervention aimed at teaching youth the evidence-based strategy of changing unhelpful thoughts (i.e., cognitive restructuring). The investigators will test the intervention's efficacy compared to an active control condition. Participants (students in grades 5-10 in U.S. schools) will be asked to complete measures of mental health and well-being prior to the intervention as well as 1, 3, and 6-months after the intervention. If the intervention is found to be effective, its brevity and scalability would make it an invaluable resource for supplementing traditional psychotherapy and potentially preventing the onset of mental illness requiring specialized intensive care.

NCT ID: NCT05720364 Completed - Healthy Clinical Trials

Study to Evaluate the Food Effect of TP-05 in Healthy Participants

Start date: January 19, 2023
Phase: Phase 1
Study type: Interventional

A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 under Fed and Fasted Conditions in Healthy Participants.

NCT ID: NCT05720013 Completed - Stroke Clinical Trials

Acute Effects of Beetroot Juice on Locomotor Economy and Capacity in Chronic Stroke

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if a beetroot juice supplement can improve oxygen capacity during walking tasks at a submaximal and maximal effort in people greater than 6 months following stroke.

NCT ID: NCT05719805 Completed - Clinical trials for Healthy Participants

A Study to Evaluate the Effects of Mavacamten in Healthy Participants

Start date: February 20, 2023
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.

NCT ID: NCT05719311 Completed - Cystic Fibrosis Clinical Trials

Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis

SPAN
Start date: February 1, 2023
Phase: Phase 2
Study type: Interventional

Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI). Currently, these patients take pancreatic enzymes that are obtained from pig pancreas to aid the digestion of food. The goals of this clinical study are to evaluate the safety and efficacy of a novel formulation of a non-porcine lipase, called adrulipase, in patients with EPI due to cystic fibrosis. The main question[s] the study aims to answer are: 1. Is the novel formulation of adrulipase safe to use at the doses being evaluated in the clinical study. 2. Is adrulipase as effective, or more effective, compared to the pig enzymes the patients currently use. Researchers will compare the results obtained with adrulipase to how the patients typically respond to their pig enzymes to see if adrulipase helps patients digest fats adequately and if their stomach feels good (signs and symptoms of malabsorption).

NCT ID: NCT05719285 Completed - Overactive Bladder Clinical Trials

Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection

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

The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder. The main question it aims to answer are: • Is the incidence of post-procedure UTI similar between single-dose and multi-day durations of peri-procedural antibiotics? Participants will be randomized to single-dose versus multi-day dose of antibiotic prophylaxis with bladder onabotulinumtoxinA injection. Researchers will compare incidence of UTI in each group to see if there is a significant difference.

NCT ID: NCT05719090 Completed - Healthy Lifestyle Clinical Trials

Acute Effects of Autoregulated and Non-autoregulated Blood Flow Restrictive Exercise on Indices of Arterial Stiffness

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

To investigate the acute effects of autoregulated (AR) and non-autoregulated (NAR) BFR exercise on indices of arterial stiffness. AR BFR training devices adjust pressure in the cuff ensuring similar pressure throughout the range of motion when the muscles are contracted (dilatated) and relaxed. NAR BFR training devices do not adjust pressure in the cuff throughout the range of motion when the muscles are contracted and relaxed which cause greater pressures at different points in the range of motion. METHODS: Following a randomized AR or NAR familiarization training session, 20 adults (23±5 years; 7 female) participated in 3 randomized treatment-order sessions with AR-BFR, NAR-BFR, and no- BFR separated by 1-week washout periods. Participants performed 4 sets of dumbbell wall squats to failure using 20% of 1 repetition maximum (1-RM) at 2-second concentric/eccentric cadence. Training limb occlusion pressure (LOP) was set at 60% of supine LOP for both the AT and NAR sessions. Testing before and immediately following the training session included ultrasonography of the carotid artery, applanation tonometry, and blood pressure acquisition. Two-way ANOVAs were used to examine the effects of treatment and the treatment-order interaction on pulse wave velocity (PWV), beta-stiffness index (β-stiff), and arterial compliance (AC). RESULTS: There were no baseline differences in CF- (carotid-femoral) PWV, CR- (carotid-radial) PWV, β-stiff, and AC (all p > 0.05). CF-PWV increased in the NAR-BFR (mean difference = 0.57±1.12 m/s, p = 0.02) and no-BFR (mean difference = 0.63±1.42 m/s, p = 0.03) groups following the exercise session. CR-PWV increased in the no-BFR (mean difference = 0.82±1.5 m/s, p = 0.03) group. And there was an interaction effect in CFPWV between AR-BFR and NAR-BFR (mean difference = 0.70±1.6 m/s, p = 0.03). CONCLUSION: These findings show acute AR-BFR training does not influence indices of arterial stiffness while acute NAR-BRF training increases central stiffness.

NCT ID: NCT05718921 Completed - Psoriasis Clinical Trials

A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers

Start date: April 8, 2023
Phase: Phase 1
Study type: Interventional

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.