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NCT ID: NCT03804151 Recruiting - Sedentary Behavior Clinical Trials

Long-term Evaluation of the FitSpirit Intervention

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates the long-term effects of the FitSpirit extra-curricular, girl-only intervention on numerous health outcomes of adolescent girls.

NCT ID: NCT03802877 Not yet recruiting - Clinical trials for Gestational Diabetes

Active Patient GDM

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Among women with GDM, we will determine if a strategy of (1) a website-based information and motivational resource bank; (2) biosensor/ePlatform-based physical activity and GWG tracking; and/or (3) a health coach will lead to more favourably outcomes; namely, GWG closer to target, higher physical activity levels, better glycemic and blood pressure control, and lower incidence of LGA in offspring. The current project is designed to assess feasibility and usability to inform the development of a large randomized controlled trial. We will monitor the implementation process and examine patient-oriented outcomes, including perceptions of utility, challenges, and burden. These will be assessed through telephone-based in-depth interview. Methodology / Study design This is a feasibility randomized controlled trial with a factorial design. We will recruit women with a diagnosis of GDM between 24 and 28 weeks' pregnancy. All will receive access to a website resource bank with tips and resources to optimize physical activity and dietary intake a quality during pregnancy. In addition, they will be randomized to one of the four following groups: (1) No additional intervention; (2) ePlatform-based automated support combined with pedometer-based physical activity monitoring and digital scale-based weight monitoring; (3) weekly telephone calls with a health coach to discuss physical activity, eating, gestational weight gain; (4) combination of ePlatform and telephone calls from a health coach. We will evaluate recruitment rates, drop-out rates, women's perceptions of the strengths and limitations of the strategy, and ease and feasibility of outcome assessment. Assessments will be through in-clinic assessments, on-line questionnaires, clinic-based measures, mailed-in pedometers, and telephone-based interviews. Assessments will be at study entry and two to three weeks before the expected date of delivery or date of scheduled C-section. There will be a telephone-based interview at 12 weeks postpartum.

NCT ID: NCT03802708 Recruiting - Clinical trials for Fetal Alcohol Spectrum Disorder

Fetal Alcohol Spectrum Disorder-Is This a Ciliopathy?

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Urine sample and exhaled Nitric Oxide will analyzed and compared between children diagnosed with Fetal Alcohol Spectrum Disorder and healthy control. Pilot study- 5 children in each group

NCT ID: NCT03802461 Not yet recruiting - Infection Clinical Trials

Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization

EFFECT-CPE
Start date: February 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Carbapenemase-producing Enterobacteriaceae (CPE) are bacteria carried in the gastrointestinal tract that are resistant to carbapenems, antibiotics of last resort. CPE infections result in death in 25-50% of cases. Fecal microbiota transplantation (FMT) is the transfer of stool from a healthy donor to a recipient to alter the composition of gut microbes. Early studies support its use for eliminating CPE carriage but definitive studies are lacking. The investigators propose a feasibility pilot for a multicenter, non-blinded randomized trial comparing the effectiveness of FMT with no intervention (standard of care) in eliminating intestinal carriage of CPE. Forty patients with CPE will be randomly assigned to receive FMT by enema or no intervention. Feasibility will be demonstrated by the ability to recruit and retain 40 patients over 12 months, and to provide FMT made at a central site to at least one off-site hospital. The primary clinical endpoint for the full trial is CPE intestinal carriage 3 months after the intervention. Secondary endpoints include: CPE carriage at 1, 6 and 12 months; time to decolonization of CPE; safety; CPE infections over 12 months; and, intestinal carriage of other antibiotic-resistant organisms. Data on the clinical outcomes will be collected but not analyzed in this feasibility study.

NCT ID: NCT03802188 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Hydroxychloroquine in Systemic Lupus Erythematosus

Start date: May 9, 2018
Phase:
Study type: Observational

A Systemic lupus erythematosus, SLE is disease in which immune system is over-active causing inflammation in joints skin or any organ system. There are many areas where better approaches in SLE could improve outcomes. One example relates to hydroxychloroquine (HCQ) key drug which can reduce risk of serious disease flares. There are increasing concerns about eye damage main side effect with long-term use of HCQ. At present investigators cannot precisely predict which SLE patient is most likely to flare once HCQ is tapered. It is not clear what drives risk of eye damage. Investigators' study will fill these knowledge gaps. Investigators' hypothesis is that baseline demographic and clinical factors are associated with risk of SLE flare after HCQ taper/discontinuation and with risk of retinal toxicity in all HCQ exposed patients. Research will link and analyze data on 3700 SLE patients across Canada.

NCT ID: NCT03801889 Not yet recruiting - Iron Overload Clinical Trials

SP-420 in Subjects With Transfusion-dependent Beta-Thalassemia or Other Rare Anemias

Start date: May 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety and tolerability of SP-420 and it's efficacy in terms of lowering iron in subjects with Beta-thalassemia or other rare anemias who need regular blood transfusions.

NCT ID: NCT03801759 Active, not recruiting - Clinical trials for Drug Interaction Potentiation

A Phase 1, Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide

Start date: July 20, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects.

NCT ID: NCT03801746 Active, not recruiting - Clinical trials for Drug Interaction Potentiation

Phase 1 Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin

Start date: July 20, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects.

NCT ID: NCT03801733 Recruiting - Clinical trials for Drug Interaction Potentiation

Phase 1, Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

Start date: June 17, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin and simvastatin in healthy male and female subjects.

NCT ID: NCT03800875 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Triple-hormone (Insulin-pramlintide-glucagon) Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting

Triple
Start date: November 10, 2018
Phase: Phase 2
Study type: Interventional

Closed-loop system systems that are shown to alleviate the burden of carbohydrate counting without degrading glucose control are still lacking. In this proposal, the investigators aim to develop a novel, fully-automated, triple-hormone, closed-loop system that delivers insulin, pramlintide, and glucagon that controls postprandial glucose levels without any input from the user.