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NCT ID: NCT05974293 Not yet recruiting - Spasticity, Muscle Clinical Trials

A Phase IIb Study of Nabiximols for Spasticity Due to Neuromyelitis Optica Spectrum Disorders

SENS-NMO
Start date: April 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and efficacy of nabiximols, a cannabinoid spray, for the treatment of moderate to severe spasticity in adult patients with AQP4-IgG positive and antibody-negative NMOSD. The main question it aims to answer is whether treatment with nabiximols improves patient-reported spasticity ratings compared to treatment with a placebo. This trial will also answer whether nabiximols impact pain, spasm frequency, mood, walking ability, and sleep. Participants will be mailed the treatments and placebo treatments, and will be asked to complete study visits and questionnaires remotely. There is also an optional sub-study that involves in-person visits with ultrasound imaging and in-person neurologic exams.

NCT ID: NCT05973942 Not yet recruiting - Suicide Prevention Clinical Trials

Population Impact of Wingman-Connect Implemented by the US Air Force

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This study involves collection of implementation data and analysis of USAF de-identified administrative data on base-level suicide attempt rates following US Air Force (USAF) delivery of Wingman-Connect training at 8 operational AF bases, as part of a force-wide scale out of the program. Implementation of Wingman-Connect by the USAF will occur over 51 months. The AF has agreed to stagger implementation based on a randomized stepped-wedge design. Once Wingman-Connect has been initiated at each base, all entering first-term Airmen will receive Wingman-Connect, with ~17,400 total Airmen receiving Wingman-Connect across all bases. Implementation. The study will directly collect data from USAF prevention personnel who are involved in the delivery of the intervention to measure fidelity and measure implementation barriers and facilitators. These base-level data are essential to test Wingman-Connect impact on suicide attempt rates in a general USAF population, to study Wingman-Connect diffusion, and to refine implementation processes and tools. Suicide Rates. Bases routinely provide their base-wide suicide attempt rates to the Air Force Medical Readiness Agency (AFMRA). AFMRA will provide these routinely-collected aggregate administrative data to this study in order to analyze changes in base-level suicide attempt rates (USAF administrative data) among the 8 bases.

NCT ID: NCT05973734 Not yet recruiting - Clinical trials for Islet Transplantation

Islet Transplantation With Recipient T-Reg Cells or Deceased Donor Vertebral Bone Marrow Therapy

Start date: October 1, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn if patients who have brittle type 1 diabetes receiving an islet transplantation will have better control of their sugars if they also receive one of 2 types of immune cells along with the islet transplant. The participants will receive either their own immune cells, called regulatory T cells, or immune cells from the bone marrow of the islet donor.

NCT ID: NCT05973669 Not yet recruiting - Clinical trials for Hearing Loss, Sensorineural

MED-EL Remote Care Multi-Center Feasibility Study

Start date: September 2024
Phase: N/A
Study type: Interventional

MED-EL Remote Care is a way for MED-EL cochlear implant users to check their hearing and cochlear implant device from any location, without the need for a scheduled, in-person appointment with their audiologist. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.

NCT ID: NCT05973071 Not yet recruiting - Contraceptive Usage Clinical Trials

Clinical Use of a Contraceptive Decision Aid and Patient Outcomes

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The study at hand aims to examine whether incorporating use of a contraceptive decision aid (Tuune for Clinics) improves outcomes for patients seeking contraceptive care. To achieve this the investigators will test: the hypothesis that use of the Tuune decision aid in contraceptive care appointments will: (a) improve patient satisfaction, (b) increase patient positivity toward contraceptive use, and (c) improve patient outcomes, including: (ci) greater adherence to their prescribed contraceptive and (cii) fewer negative side-effects, relative to that which is observed for patients receiving a contraceptive recommendation from a traditional contraceptive counseling appointment.

NCT ID: NCT05972681 Not yet recruiting - Clinical trials for Vaginal Laceration During Delivery

The PAIN (Pelvic Area Injection for Numbness) Study

Start date: May 31, 2024
Phase: N/A
Study type: Interventional

The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair of such lacerations in the institution is usually done using lidocaine for non-epiduralized patients versus no local injection in patients with a pre-existing epidural analgesia. The prevalence of epidural analgesia use among women who underwent vaginal delivery in cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled postpartum pain which can affect both the physical and mental recovery period, extend hospital stays, and increase the potential for serious adverse reactions with pain medications. The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction. This is a superiority two-arm, quadruple-blinded, prospective randomized controlled trial with the objective to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair. Women with a working epidural analgesia, and status post a vaginal delivery involving a second-degree laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get an injection with saline. The differences in perineal pain between the groups will be evaluated at time of the first analgesic (TFA) demand, maternal satisfaction at 24 hours, and visual analog scale (VAS) pain score.

NCT ID: NCT05969080 Not yet recruiting - Clinical trials for Self-Injurious Behavior

Self-Injury Treatment and Recovery in Veterans

STRIVe
Start date: March 1, 2025
Phase: N/A
Study type: Interventional

Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans.

NCT ID: NCT05968924 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology

DFUMAT
Start date: May 2024
Phase: N/A
Study type: Interventional

The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period. The device is a foot mat, which can detect changes in foot temperature that may predict foot ulceration in patients with diabetes mellitus. This mat, the Podimetrics Smart Mat, is FDA cleared.

NCT ID: NCT05968755 Not yet recruiting - HIV Prevention Clinical Trials

Leveraging Chatbot to Improve PrEP in the Southern United States

Start date: June 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.

NCT ID: NCT05968716 Not yet recruiting - Clinical trials for Utilization, Health Care

Addressing Unmet Social Needs Among Hospitalized Children

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

The purpose of this pilot study is to determine the feasibility and acceptability of implementing a social needs screening and intervention protocol in the pediatric inpatient setting by conducting a pilot trial on a pediatric ward. The investigators' hypothesis is that it will be feasible and acceptable to implement a social needs screening and intervention protocol. The investigators will work with pediatric word healthcare team members to develop a social needs screening and intervention protocol. They will then compare preliminary health and social outcome measures between children hospitalized during the pre-intervention period (control group) vs. the post-intervention period (intervention group).