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NCT ID: NCT05073302 Recruiting - Type 1 Diabetes Clinical Trials

Device-Less Technique in Islet Transplantation

Start date: March 22, 2022
Phase: Phase 1
Study type: Interventional

Islet transplantation is an effective modality for treating type 1 diabetes. Despite marked progress in clinical islet transplantation with the achievement and maintenance of insulin independence in over half of recipients up to 5 years, transplant approaches are limited to those that struggle to control their diabetes. Furthermore, this approach remains restricted due to the scarcity of human pancreas donors. While transplanting insulin-producing cells into the liver has been demonstrated as an efficacious means of restoring glycemic control to patients with T1D, the procedure often results in cell loss, and carries risks. Moreover, transplant in to the liver does not permit imaging or retrieval of donor islets. The ability to retrieve the cells is also important for safety reasons. In theory, the space under the skin is an attractive alternate site for transplanting insulin producing cell, due to ready access, and potential for monitoring cellular transplant function through novel imaging techniques. However, transplantation of insulin producing cells into an unmodified site under the skin universally fails to reverse diabetes in research animal models, or in human studies. Other techniques using devices with different type of technologies and biomaterials have been explored with variable success. Unfortunately, the foreign body and inflammatory reaction persist in the implant. Shapiro Lab, has developed a novel technique called 'device-less' (DL) transplant modality. This approach was designed to harness an innate foreign body response in a favorable and controlled manner, to induce growth of new blood vessels to allow the survival of the insulin producing cells without the natural body response to foreign body. Briefly, this site transforms the inhospitable under the skin site into a viable location through the temporary implantation of a small tube called angiocatheter. For this study, 5 patients will received transplant in to the modified site under the skin using the DL transplant technique.

NCT ID: NCT05073081 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Feasibility of Prehab for Lumbar Spinal Stenosis

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

The literature has shown evidence of the effectiveness of prehabilitation programs on post-operative recovery for musculoskeletal conditions; however, evidence for prehabilitation for lumbar spinal stenosis (LSS) is limited. Investigators have found that there is very low to low quality evidence for the effect of prehabilitation interventions for improving outcomes following lumbar spine surgery. Therefore, the purpose of this study will be to determine the feasibility of a prehabilitation program for patients undergoing LSS surgery, and pilot test the protocol to provide the foundation for future design of a larger, multicenter randomized controlled trial.

NCT ID: NCT05072743 Recruiting - Sleep Disorder Clinical Trials

Improvement in Sleep Symptomatology and Neurocognitive Function Using Photobiomodulation in Post-Concussion Patients

Start date: October 20, 2021
Phase: N/A
Study type: Interventional

The emphasis on this study is to review the use of PBMT as a potential treatment modality to improve both sleep symptoms and consequent neuropsychological functions affected by sleep disturbances in a cohort of post-mTBI patients with sleep issues not secondary to sleep apnea.

NCT ID: NCT05072548 Recruiting - Sleep Problems Clinical Trials

The ABCs of SLEEPING: Effectiveness Study

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

This trial will examine the effectiveness of a mobile applicable intervention called the "ABCs of SLEEPING". This intervention provides parents with prioritized/customized sleep recommendations and a sleep report based on their responses to the "Sleep check-in". This app is evidence-based and developed by sleep researchers and its aim is to provide accessible evidence-based sleep information for parents of children aged 6 to 12 years of age.

NCT ID: NCT05072392 Not yet recruiting - Nasal Bleeding Clinical Trials

Determining the Effects of Foley Catheter-assisted Nasal Intubation on Nasal Bleeding in Adult Patients

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

Nasal endotracheal intubation is a well-utilized and important endotracheal intubation route to allow good surgical access for operations involving the oral cavity. Despite its utility, there are potential complications from nasal endotracheal intubation including that of nasal bleeding, which in severe cases can impair the ability to complete the procedure. The most accepted conventional practice to decrease bleeding associated with nasal endotracheal intubation is to warm the nasal endotracheal tube prior to insertion. However, this technique still yields high rates of nasal bleeding. In 1979, correspondence by MacKinnon and Harrison in Anaesthesia described the use of a flexible urinary catheter (Foley catheter) telescoped onto the endotracheal tube tip to aid atraumatic insertion of the tube. This also served to ensure the tube was not contaminated internally by nasal secretions or blood. This has been more rigorously studied in two RCTs looking at this technique in children, but there has been no similar study in adults. This study aims to extend the evidence base of the use of this technique in adults. Our hypothesis is that the use of a flexible urinary catheter to telescopically aid nasal intubation will result in a significant decrease in the incidence and severity of nasal bleeding.

NCT ID: NCT05072288 Recruiting - Clinical trials for Myotonic Dystrophy Type 1 (DM1)

A Remote Physical Activity Program in the Population Suffering From Type 1 Myotonic Dystrophy

Start date: August 11, 2021
Phase: N/A
Study type: Interventional

The COVID-19 pandemic exacerbates health problems by reducing access to adapted and advanced physical rehabilitation for several people who need rehabilitation services, including the population with myotonic dystrophy type 1 (DM1). The PACE tool, an innovative web tool integrating pragmatic physical activity programs, seems to be an interesting and innovative intervention to counter physical deficiencies of people with DM1, which are unfortunately accentuated by the pandemic, while reducing the risk of COVID-19 exposure. Objectives: 1) Evaluate the feasibility, usability and acceptability of the PACE tool in the DM1 population; 2) Evaluate the effects of the intervention on their physical and cognitive health; and 3) Estimate the cost-effectiveness ratio of this intervention. Method: Sixty people (experimental group = 40 and control group = 20) will participate in this randomized intervention study. Participants in the experimental group will be assigned to one of the 35 physical activity programs adapted to their condition of the PACE tool. The program must be performed on a daily basis for a period of 12 weeks. Physical and cognitive health will be assessed before and after the remote intervention via ZOOM, for all participants.

NCT ID: NCT05072210 Completed - Depression Clinical Trials

Mobile Interventions for the Prevention and Detection of Distress

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

Stress, anxiety, distress and depression are exceptionally high among healthcare providers at the frontline of the COVID-19 pandemic. Knowledge of factors underlying distress and resilience and evidence based interventions to impact the mental wellbeing of frontline healthcare providers is limited. This study will evaluate a novel mobile platform to gather the "distress experience" of healthcare workers at Unity Health Toronto in real time during and after the COVID-19 pandemic, use automated personalized mobile interventions (e.g. routine, sleep, exercise) to nudge active/passive parameters to manage distress.

NCT ID: NCT05071768 Completed - Depression Clinical Trials

Virtual Focused ACT Groups in Primary Care

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

Acceptance and commitment therapy (ACT) is a transdiagnostic intervention whose aim is to reduce experiential avoidance and promote psychological flexibility, which involves engaging in values-based behaviour while accepting painful internal experiences with openness and awareness. A growing body of research supports the efficacy of brief ACT for a variety of issues, including depression, anxiety, chronic pain, and stress. Given that ACT is a transdiagnostic intervention that targets the core processes related to human suffering, this treatment may be particularly useful for implementation in primary care with diverse groups of individuals and presentations. The objective of this study is to develop and pilot test a brief, virtual, group-based ACT intervention for depression and anxiety delivered in primary care settings to determine if a future randomized controlled trial of this group treatment is both warranted and feasible. The investigators will examine (1) the feasibility and acceptability of the study procedures, (2) clinician adherence to the treatment protocol, and (3) a preliminary analysis of the treatment effectiveness. A total of 3 groups (N = 30-45) will be conducted via three primary care clinics in Winnipeg, Manitoba, Canada. The group treatment will be delivered over four 90-minute sessions. Participants will complete assessment measures at pretreatment, post-treatment, and at two follow-up time points (1-month post-treatment and 3-6-months post-treatment). All assessments and treatment sessions will be conducted virtually via videoconferencing platform.

NCT ID: NCT05071716 Active, not recruiting - Clinical trials for Hepatic Encephalopathy

Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

RED-C-3131
Start date: April 7, 2022
Phase: Phase 3
Study type: Interventional

Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.

NCT ID: NCT05071300 Recruiting - Clinical trials for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

A Study to Assess the Long-Term Safety and Efficacy of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Start date: January 4, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of extended dosing with Eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN).