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NCT ID: NCT06217380 Terminated - Opioid Use Clinical Trials

Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

Start date: September 20, 2023
Phase: N/A
Study type: Interventional

This Clinical Trial will evaluate the Feasibility and Acceptability of Oxygen Saturation Monitoring using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

NCT ID: NCT06217367 Recruiting - Allergic Rhinitis Clinical Trials

Over-the-Counter Antihistamines & Heat Stress

Start date: December 5, 2023
Phase: Phase 4
Study type: Interventional

Allergic rhinitis (AR) currently affects ~25% of Canadians, and due to factors of climate change, this number is expected to increase over the coming decade. AR symptoms can significantly impact individuals' quality of life by compromising sleep, productivity, and social interactions. To alleviate AR symptoms, North Americans tend to rely on H1 antihistamine medications available over-the-counter (OTC) at most pharmacies. However, public health authorities currently suggest restraining all antihistamines during heat waves due to beliefs that M3 muscarinic receptor and H1 receptor antagonism, independent pharmacological mechanisms of H1 antihistamines, might suppress thermoregulatory responses to heat stress and increase individuals' susceptibility to heat-related illness/injury. To date, studies using supramaximal doses of antihistamines have demonstrated reductions in sweating, however these doses and administration routes are not the typical use case. Additional studies utilizing fexofenadine, a second-generation H1 antihistamine, have linked H1 receptor antagonism to reductions in skin blood flow, potentially impacting thermoregulation by reducing peripheral blood redistribution. Empirical evidence supporting OTC H1 antihistamines impacting thermoregulatory control at recommended doses is scarce. Thus, this study aims to systematically assess whether three common OTC H1 antihistamines, taken as prescribed, alter thermoregulatory responses during thermal stress.

NCT ID: NCT06217315 Active, not recruiting - Endometriosis Clinical Trials

Endometriosis and Health Care System Utilization in British Columbia

EndoCare
Start date: October 18, 2022
Phase:
Study type: Observational

Purpose & Background Endometriosis is a chronic inflammatory condition believed to affect 8-10% of reproductive-age women and an unmeasured number of gender-diverse people. It is a common cause of pelvic pain and infertility, is now known to be associated with other conditions such as heart disease and ovarian cancer and can have a devastating impact on a woman's ability to function and achieve their full potential. It has been shown that endometriosis and chronic pelvic pain are associated with considerable costs to the health-care system in Canada. The in-patient hospital costs for chronic pelvic pain were estimated to be $25 million/year and the total societal costs for endometriosis were estimated to be 1.8 billion/year. Standard therapies for endometriosis and pelvic pain include pain medications, hormonal suppressive therapies, and surgery. There is a tertiary referral centre of excellence for endometriosis at BC Women's Hospital (Centre for Pelvic Pain and Endometriosis), which provides advanced surgical treatment of endometriosis and interdisciplinary care for patients with endometriosis who have developed other pain comorbidities (e.g. due to central nervous system sensitization). Central sensitization responds best to treatments targeted to the nervous system, such as Interdisciplinary care includes pain education, physiotherapy, and mindfulness-based cognitive therapies. One randomized trial has shown the benefit of an interdisciplinary approach compared to standard treatment for the management of chronic pelvic pain. At our centre, the investigators reported improvements in pain, mental health, quality-of-life, and self-reported reduction in health care utilization, after interdisciplinary care, utilizing our ongoing prospective registry. However, a formal economic analysis of health care system utilization is required to quantify savings to the health care system with an interdisciplinary approach to endometriosis. Despite surgery being a common treatment of endometriosis, there is variability in outcome and a gap is the lack of ability to predict outcomes after endometriosis surgery. For example, utilizing self-reported outcomes from our registry, the investigators found that poorer outcome after endometriosis surgery was found in patients with evidence of pain comorbidities and central sensitization (as surgery is not a direct treatment of these factors) (in preparation). Moreover, the investigators have a biobank and have been studying biomarkers in surgically excised endometriosis tissue that may predict outcomes after surgery. These biomarkers include somatic cancer driver mutations and neuroinflammation. The investigators have preliminary data that suggests that these biomarkers may predict rates of re-operation at the centre. Beyond self-reported outcomes and re-operation at the centre, there is a need to assess health care utilization and re-operation occurring throughout the province as additional outcomes that may be associated with our clinical and biomarker predictors. Finally, the SARS-CoV-2 (COVID-19) pandemic has had profound physical and mental health effects on populations worldwide. However, there exists limited empirical evidence focusing on the wellbeing of patients with endometriosis and/or pelvic pain during the public health crisis. Herein, the investigators propose to compare a pre-pandemic cohort to a pandemic cohort of subjects with endometriosis and/or chronic pelvic pain, again in terms of health care system utilization. Therefore, the overall purpose of this project is to assess health care utilization patterns of patients with endometriosis in British Columbia, and to perform an economic analysis of interdisciplinary care, evaluate clinical-biomarker predictors of surgical outcome, and assess the impact of the covid pandemic. This will be achieved by linking Population Data BC datasets to our ongoing prospective registry (H16-00264) and prospective and retrospective biobanks (H14-03040, H17-00329).

NCT ID: NCT06217302 Not yet recruiting - Heart Failure Clinical Trials

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

SUGARNSALT
Start date: May 2024
Phase: Phase 3
Study type: Interventional

Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.

NCT ID: NCT06217159 Recruiting - Cerebral Blood Flow Clinical Trials

Mechanistic Effect of Ketones on Cerebral Blood Flow

MEKC
Start date: January 19, 2024
Phase: N/A
Study type: Interventional

Oral supplements containing exogenous ketones have recently become available and represent a novel tool for increasing plasma ketone bodies without the need for dietary restriction. Early evidence suggests that oral ketone supplements may enhance cerebral blood flow (CBF). However, a higher dose of a ketone monoester has been shown to slightly lower blood pH and reduce end-tidal CO2 (PetCO2) due to compensatory hyperventilation, which is accompanied by parallel reductions in CBF. Whether reductions in PetCO2 causes reductions in CBF is currently unknown. The purpose of this study is to investigate the effect of manipulating PetCO2 at normocapnia (PetCO2 maintained at baseline) or poikilocapnia (no PetCO2 targeting; breathing room air), following the ingestion of a dose of a ketone monoester on CBF and cerebrovascular reactivity to CO2 in young adults.

NCT ID: NCT06217120 Not yet recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

COL-Micro-HF
Start date: March 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the impact of colchicine on the change in coronary flow reserve (CFR), a marker for coronary microvascular dysfunction (CMD), compared to placebo in patients with heart failure and ejection fraction above 40% (including patients with improved EF).

NCT ID: NCT06216899 Recruiting - Crohn Disease Clinical Trials

Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

mRE-EEN
Start date: March 11, 2024
Phase: N/A
Study type: Interventional

This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD). Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.

NCT ID: NCT06216470 Recruiting - Clinical trials for Hepatitis B, Chronic

Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]

Start date: March 13, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection. The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body. This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.

NCT ID: NCT06216028 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis

ACCELERATE3
Start date: September 2024
Phase: Phase 3
Study type: Interventional

The purpose of the ACCELERATE3 trial is to assess the efficacy of a single intra-articular (IA) injection of autologous BMAC, in one or both knees, compared to a single IA injection of Standard of Care (SOC) in patients with mild to severe knee OA.

NCT ID: NCT06215963 Recruiting - Clinical trials for Opioid-Related Disorders

A4i-O: A Platform for Complex Behavioral Health to Address OUD

Start date: February 5, 2024
Phase: N/A
Study type: Interventional

For the purposes of beta testing the first version of A4i-O, 15 individuals with OUD will use the platform for one month. From a design perspective this sample size is viewed as being sufficient to answer questions regarding app functionality and feasibility before moving to larger trials. Additionally, 15 individuals is a larger sample size than in the A4i pilot. This is an open label pilot with a primary objective of troubleshooting and providing early feedback on the beta version of the technology. To that end, 15 participants are anticipated to be sufficient to provide robust, early feedback. As with the focus groups, through sampling an effort will be made to secure a diverse group. Any individuals who might be declined in that effort at this stage (e.g., it is determined that no more male identifying participants are needed but they were interested) would be invited to take part in the subsequent RCT.