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NCT ID: NCT05996003 Recruiting - Clinical trials for Duchenne Muscular Dystrophy

NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)

Start date: February 22, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, multi-center, 2-part study of NS-089/NCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to <15 years with DMD due to mutations amenable to exon 44 skipping. Participants will receive a selected dose of NS-089/NCNP-02 administered once weekly. The study consists of 2 parts: Part 1 and Part 2. Six participants (Cohort 1) will participate in both Part 1 and Part 2, and 14 participants (Cohort 2) will be added for Part 2.

NCT ID: NCT05995964 Recruiting - Atopic Dermatitis Clinical Trials

A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Start date: August 22, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis (AD). AD is a long- lasting itchy red rash, caused by a skin reaction. This study is seeking participants who: - are 18 years of age or more. - Were confirmed to have AD at least 6 months ago. - Are not having an effective treatment result from medicines that are applied on skin for AD. - Are considered by their doctors to have moderate to severe AD. All participants in the study will receive either PF-07275315 or PF-07264660 or placebo. A placebo does not have any medicine in it but looks just like the medicines being studied. PF-07275315 or PF-07264660 or placebo will be given as multiple shots in the clinic over the course of 12 weeks. Stage 1 participants will receive shots at the study clinic on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12. Stage 2 participants will receive shots at the study clinic on Day 1, Week 4, Week 8 and Week 12. The experiences of people receiving PF-07275315 or PF-07264660 will be compared to people who do not. This will help determine if PF-07275315 and PF-07264660 are safe and effective. Participants will be involved in this study for up to 40 weeks (20 months). During this time, Stage 1 participants will have 16 visits at the study clinic, and Stage 2 participants will have 12 visits at the study clinic.

NCT ID: NCT05995899 Recruiting - Clinical trials for IBS - Irritable Bowel Syndrome

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

Start date: February 6, 2024
Phase: Phase 4
Study type: Interventional

The aim of this study is to better understand how tenapanor affects the metagenomics and metabolomics of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is the newest FDA-approved agent for IBS-C. It is a small molecule that inhibits the NHE3 receptor, leading to impaired sodium and water absorption in the intestine. Previous clinical trials comparing tenapanor to placebo showed that a 50 mg dose of tenapanor led to increased bowel movements and decreased abdominal pain. This study consists of an 8-week treatment period in which subjects will ingest one capsule of tenapanor (50 mg per dose), twice daily, and send in stool samples following 4 weeks and 8 weeks of treatment.

NCT ID: NCT05995886 Recruiting - Opioid Use Disorder Clinical Trials

Using Facebook to Support Opioid Recovery Among American Indian Women

Start date: October 16, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to find out whether a Facebook group will help Native women in recovery from opioid use.

NCT ID: NCT05995873 Recruiting - Opioid Use Clinical Trials

A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.

Start date: January 22, 2024
Phase: N/A
Study type: Interventional

Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the investigators determine to be healthier, more mature, and less traumatized. Investigators will compare among actively using participants an active and a sham treatment given either once or twice weekly for 25-weeks at 2 sites. Investigators hope this will lead to a significant weapon in the battle against the opioid epidemic as well as lead to psychological and physiological insights into possible relations among trauma, cerebral laterality, and addiction.

NCT ID: NCT05995860 Active, not recruiting - Clinical trials for Stage IV Ovarian Cancer

Study of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery

PRECursOr
Start date: June 14, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to help test an idea designed to foster more supportive talk between providers (doctors or nurse practitioners), patients, and caregivers during an outpatient oncology appointment. A caregiver is the person the patient identifies is primarily involved in their healthcare. This study is collecting your reaction to this idea in order to understand needed changes before we introduce the idea to a larger group of patients.

NCT ID: NCT05995821 Recruiting - Lung Cancer Clinical Trials

Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies

Start date: August 25, 2016
Phase:
Study type: Observational

This research is being done to collect and store biological specimens (biospecimens) from people with cancer, regardless of tumor type, who are receiving treatments known or thought to have an effect on the immune system. The goal of this discovery and exploratory study is to: - Understand changes in the immune system associated with various cancer treatments, in order to better design new therapies or tests to predict how these treatments might work. - Identify risk factors for those who go on to develop side effects from immunotherapy. Participants may be asked to: - Donate samples of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal smears) scraped from the inside of participant's cheek, urine, saliva, or other tissue samples. - Complete questionnaires about immunotherapy side effects at baseline and with follow-up appointments. - Undergo knee x-rays. - Allow the use of demographic and clinical information.

NCT ID: NCT05995678 Recruiting - PTSD Clinical Trials

A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans

SH-SP
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Risk of Veteran suicide is elevated during the first year of transition from military service to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA healthcare. Suicide prevention and connection to care are therefore critical for recently transitioning Veterans. Transitioning Veterans require services to provide them with suicide prevention education, skills to manage their transition effectively, and support in their access to VA healthcare. Convenient, accessible, palatable, patient-centered care options that are cost-effective, easy to implement nationwide, and target domains known to mitigate suicide risk are needed during this critical transition period. This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education, skills to improve transition, support to access VA care, and a platform to decrease social isolation early in their military to civilian transition, thereby reducing suicide risk downstream.

NCT ID: NCT05995626 Recruiting - Scleroderma Clinical Trials

Hyaluronidase Via LADD Scleroderma-induced Microstomia

Start date: March 1, 2024
Phase: Early Phase 1
Study type: Interventional

Two treatment methods, ablative carbon dioxide (CO2) laser and intradermal hyaluronidase, will be combined to maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown to be effective for the administration of medications in diverse skin diseases but not previously reported for the treatment of scleroderma-induced microstomia. By using this laser technique, the investigator can reduce the pain of typical hyaluronidase injections and reap the therapeutic benefit of the laser treatment itself. The investigator's goal is to create greater mouth mobility for chewing and speaking as well as improved oral hygiene, self-esteem, and overall quality of life. Each participant will undergo three separate laser sessions at 4 to 8-week intervals. Participants will also complete a follow-up visit three months after the last laser session to evaluate the response.

NCT ID: NCT05995613 Recruiting - Oxygen Saturation Clinical Trials

Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of Color

Start date: September 6, 2023
Phase:
Study type: Observational

Purpose: Investigate the safe wearability and basic functionality - epidermal melanin concentration and blood oxygen estimation - of our developed device: Melanin-Adjusted Blood Oxygen Sensor (MABOS) Participants: Healthy adults 18-65 years of age Procedures (methods): The investigators plan to enroll 12 healthy adult participants for the study. The investigators aim to enroll 4 participants with skin tones associated with those of African descent (Group A), 4 of East Asian descent (Group B), and 4 of European descent (Group C). Additionally, the investigators aim to ensure half of group is male, and the other half female. For the duration of the study, two wearable devices will be placed on the participant: a Nonin PureSat pulse oximeter on a forefinger, and the novel wearable pulse oximeter - MABOS - on the other forefinger. Prior to testing, an Ocean HR2 XR Spectrometer will be used to assess the absorbance of three wavelengths of light - 410, 660, 940 nm - on each patient's inner wrist. Following this, the two devices will be placed on the patient, set up, and calibrated for 10 minutes. During the calibration period, MABOS will be used to measure the same three wavelengths of light utilized by the Ocean HR2 XR Spectrometer (410, 660, and 940 nm). After the calibration period, all participants will be asked to perform the following procedure 5 times as part of the testing period: a deep inhalation lasting no longer than 10 seconds, followed by a slow exhalation lasting no longer than 30 seconds. Between each trial, a five-minute break will be required. For the entire testing period, all two devices will be continuously acquiring data. After this testing period, all two devices will continue taking measurements until 90 minutes have elapsed. Skin integrity will be examined before spectrometer use, after spectrometer use, after the calibration period, every 30 minutes after the start of the testing period, and after the testing period. During the study, if the participants report any uncomfortable feeling and/or pain or if a change to the skin at the site of device placement occurs, the measurements will be discontinued, and all the devices placed on the participants will be removed. Questionnaires will be provided after the study period and during follow-up visits approximately 48 hours and 96 hours post the device testing visit for a proof-of-concept evaluation of the safe wearability.