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NCT ID: NCT04580901 Recruiting - Clinical trials for Postpartum Depression

IPT-G for Mums With Postpartum Depression

OPTIMUM
Start date: December 21, 2020
Phase: N/A
Study type: Interventional

Postpartum depression is a very common and costly illness with numerous, long-term deleterious effects for women, their offspring and families; yet most women are not treated. Group IPT delivered virtually offers women a 1st-line, low-cost intervention that overcomes existing treatment barriers. To test its acceptability and effectiveness, a RCT will be conducted to compare virtually delivered group IPT immediately to usual care in women in Ontario Canada who have postpartum depression.

NCT ID: NCT04580225 Recruiting - Arthritis Clinical Trials

Randomized Comparison of PARtial Wrist Fusion With or Without Triquetral Excision (PARTE)

PARTE
Start date: January 7, 2021
Phase: N/A
Study type: Interventional

This randomized clinical trial (RCT) aims to compare clinical and radiographic outcomes of different partial wrist fusion techniques in participants with post-traumatic wrist arthritis. Participants with stage II or III scapholunate advanced collapse (SLAC) or scaphoid nonunion advanced collapse (SNAC) who meet the eligibility criteria will be randomly assigned to one of two parallel groups: Group A (partial wrist arthrodesis without triquetral excision i.e. four-corner arthrodesis), or Group B (partial wrist arthrodesis with triquetral excision i.e. three-corner or capitolunate arthrodesis with triquetral excision). The results of this study will provide evidence to guide surgeons in determining the ideal wrist fusion technique in the management of patients with post-traumatic wrist arthritis requiring surgery.

NCT ID: NCT04579978 Recruiting - Clinical trials for Advanced Solid Tumor

Tumor Immunotherapy and Microbiome Analysis

TIME
Start date: April 1, 2018
Phase:
Study type: Observational

The composition of the gut microbiome has been associated with response and the development of toxicities on immune checkpoint inhibitors (ICIs) in multiple tumor types. The aim of this study is to examine the gut microbiome composition in patients undergoing standard of care treatment for advanced/unresectable and/or metastatic solid tumors with ICIs. Fecal samples and peripheral blood samples will be collected to further characterize the diversity of gut bacteria and to study potential mechanisms by which gut bacteria impact the immune response.

NCT ID: NCT04579900 Recruiting - Type 2 Diabetes Clinical Trials

Dissecting Host-microbiome Modifiers of Type 2 Diabetes Risk

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

It is now well documented that changes in gut microbiota composition accompany obesity and type 2 diabetes (T2D) and contribute to low-grade inflammation, insulin resistance,and glucose intolerance. It is not yet clear if T2D predisposes the intestine to allow more microbial products or possibly live bacteria to subvert the gut mucosal barrier. However, it is known that hyperglycemia during T2D induces a more permissive gut barrier allowing increased penetration of microbes and their products into the blood. An important next step is to determine which strains of bacteria promote dysbiosis, allowing bacteria or bacterial components to subvert the gut barrier and alter glucose control. It is hypothesized that gut microbes in the colon and other lower gut segments are key modulators of energy balance, glucose homeostasis and insulin sensitivity.

NCT ID: NCT04579484 Recruiting - Clinical trials for Metastatic Breast Cancer

Determinants of Acquired Endocrine Resistance in Metastatic Breast Cancer: A Pilot Study

ENDO-RESIST
Start date: February 4, 2019
Phase:
Study type: Observational

This is a single-center prospective study involving analysis of circulating tumor DNA (ctDNA) and the gut microbiome in patients with metastatic breast cancer on standard of care endocrine therapy with an aromatase inhibitor in combination with an inhibitor of the cyclin-dependent kinases 4 and 6 (CDK 4/6). Up to 20 patients with Estrogen Receptor positive (ER+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) metastatic breast cancer and Eastern Cooperative Oncology Group (ECOG) performance status 0-1 will be enrolled. This study involves the collection and analysis of patient samples and does not involve therapeutic intervention.

NCT ID: NCT04578652 Recruiting - Insulin Resistance Clinical Trials

Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance

Start date: October 22, 2021
Phase: Phase 3
Study type: Interventional

This is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (MET) alone and in combination over 12 months on glucose metabolism (insulin resistance [IR]), inflammation and BMI in adolescents with obesity and IR, and to assess the relationship between therapeutic intervention(s) and changes in gut microbiome composition and function. Since MET and FIBER have been shown to reduce weight and increase insulin sensitivity through distinct but overlapping mechanisms of action, our central hypothesis is that the combination of FIBER + MET will have a synergistic effect and be more effective than FIBER or MET alone in improving metabolic function (IR) and reducing BMI and inflammation in adolescents with obesity, IR and family history (FM) of T2DM. .

NCT ID: NCT04578392 Recruiting - Crohn Disease Clinical Trials

MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)

SPARES
Start date: July 28, 2020
Phase: N/A
Study type: Interventional

Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence. Endpoints - Primary endpoint; 6 months Secondary endpoints at 1 and 5 years post ileocecal resection Study population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection. Study sites - Multicenter international study Description of study intervention - Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection Participate duration - 5 years

NCT ID: NCT04577690 Recruiting - Pain, Postoperative Clinical Trials

PECS Study for CIED Implantation Surgery

Start date: December 1, 2019
Phase: Phase 4
Study type: Interventional

We aim to determine whether pectoral nerve block (PECS) performed after induction of anesthesia but before surgical incision results less opioid use in the post operative period compared with local infiltration alone in children undergoing Cardiac Implantable Electronic Device (CIED) surgery.

NCT ID: NCT04576117 Recruiting - Clinical trials for Recurrent WHO Grade 2 Glioma

A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

Start date: February 16, 2021
Phase: Phase 3
Study type: Interventional

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

NCT ID: NCT04575883 Recruiting - Clinical trials for Congenital Heart Disease

HIIT in Youth With Congenital Heart Disease (MedBIKE)

Start date: November 22, 2022
Phase: N/A
Study type: Interventional

Congenital heart disease (CHD), the most common birth defect, is present in nearly 1% of the population. CHD patients are associated with intense resource utilization and premature death in adulthood. The risk of premature death is linked with reduced exercise capacity, a finding consistently noted in youth with CHD. Reduced exercise capacity in this population has also been associated with reduce physical activity and health-related quality of life. Cardiac rehabilitation (CR) in adults with acquired heart disease is an established secondary prevention strategy that improves exercise capacity. The investigators propose a prospective clinical trial of a home-based high intensity interval training (HIIT) program using a novel telemedicine-equipped video game-linked cycle ergometer (MedBIKE™) for 10 to 18 year olds with repaired moderate-complex CHD. The pilot study with the MedBIKE has shown promising results. The investigators now seek to study the efficacy of this program in a broader CHD population.