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NCT ID: NCT03260868 Terminated - Clinical trials for Type 1 Diabetes Mellitus

Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)

Start date: September 19, 2017
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate the effect of virtual approach via novel technologies versus traditional study conduct on glycemic control in terms of glycated hemoglobin (HbA1c). Secondary Objective: To evaluate the appropriate utilization of virtual approach via novel technologies during the study and to assess the effect of the virtual versus traditional study conduct on multiple outcomes in terms of study methodology and diabetes management.

NCT ID: NCT03259308 Terminated - Ulcerative Colitis Clinical Trials

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

FIGARO UC 302
Start date: December 5, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03259178 Terminated - Clinical trials for Concussion; Syndrome

Correlation Between Changes in Measures of the Visual System and Changes in Concussion-associated Symptoms

Start date: June 8, 2017
Phase:
Study type: Observational

Sports-related concussion affect 1.6 to 3.8 million people each year in the United States. Despite increased media attention and awareness campaigns, the exact number is difficult to determine due to underreporting by athletes. The types of symptoms experienced with a concussion depend on the area of the brain that was affected. The most frequent symptoms include: headaches, cognitive difficulties, dizziness, neck pain, visual disturbances, difficulty sleeping, and fatigue. Despite the availability of many treatment options, some patients continue to experience many symptoms - such as headaches, dizziness, visual disturbances, balance problems, sensitivity to light, and difficulties concentrating - that negatively affect school, work, and quality of life for long periods of time. All of these symptoms are similarly experienced by individuals with visual dysfunctions, such as the inability of the eyes to move together. This finding has led some to recommend a visual component in concussion management. Therefore, the purpose of this study is to determine whether changes in the results of 7 binocular vision tests (BVT) over time in patients with concussion correlate with changes in concussion symptoms. The investigators will measure 46 concussion patients aged 18 to 30 years with each of these tests and assess their concussion symptoms on up to four separate visits, which depend on when the patient's symptoms improve. The tests the investigators will evaluate measure: 3D vision, uniform movement of the eyes, ability of the eyes to adapt to a target moving towards and/or away from the eyes, quick movements of the eyes, natural alignment of the eyes, and double vision as a target is moved towards the eyes. In addition, concussion symptoms will be measured by a standardized concussion questionnaire (SCAT3) at each visit. The results of each BVT will be entered into a statistical model with the participant's concussion symptom score to determine if there is an association between the change in symptoms and the change in the results of the tests.

NCT ID: NCT03251924 Terminated - Cancer Clinical Trials

A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

Start date: September 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.

NCT ID: NCT03251872 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Olaparib for PAH: a Pilot Study

OPTION-p
Start date: October 25, 2018
Phase: Early Phase 1
Study type: Interventional

The main OBJECTIVE of this proposal is to extend our preclinical findings on the role of DNA damage and poly(ADP-ribose) polymerases (PARP) inhibition as a therapy for a devastating disease, pulmonary arterial hypertension (PAH), to early-phase clinical trials. We, and others, have published strong evidence that DNA damage accounts for disease progression in PAH and showed that PARP1 inhibition can reverse PAH in several animal models1. Interestingly, PARP1 inhibition is also cardioprotective. Olaparib, an orally available PARP1 inhibitor, can reverse cancer growth in animals and humans with a good safety profile, and is now approved for the treatment of ovarian cancer in Canada, Europe and the USA. The time is thus right to translate our findings in human PAH. The industry-sponsored clinical research on PARP1 inhibitor is currently entirely cancer-oriented. Nonetheless, AstraZeneca Canada accepted to support an early phase clinical trial through in-kind contribution, but the support from foundations and federal agencies is critical to catalyze early-stage development of PARP1 inhibitors for other indications, especially for orphan diseases. A CIHR Project Scheme grant will thus be submitted on September 15 2017, proposing a Phase 1, followed by a Phase 2 trial that will be conducted in recognized PAH programs throughout Canada. At this stage, however, we propose a pilot study to assess the feasibility of the proposed trials in the PAH population. The overall HYPOTHESIS is that PARP1 inhibition with olaparib is a safe and effective therapy for PAH. The primary objective of the study is to confirm feasibility, to support the safety of using olaparib in PAH patients, and precise the sample size of the coming Phase 1B trial. The feasibility of the comprehensive patient phenotyping that will be proposed within the phase 1B trial will thus be assessed, in addition to adverse events and efficacy signals. ***OPTION pilot trial was merged with the new OPTION multicenter trial (NCT03782818)***

NCT ID: NCT03250468 Terminated - Clinical trials for Cardiovascular Diseases

Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients

Start date: April 19, 2018
Phase: N/A
Study type: Interventional

Research aims: 1. To determine if participation in a group-based cognitive behavioural therapy intervention (CBT-I) intervention results in improved sleep quality. 2. To determine if participation in a group-based CBT-I intervention results in improved cardiovascular disease risk factors, and if the CBT-I intervention moderates that relationship.

NCT ID: NCT03249727 Terminated - Colorectal Cancer Clinical Trials

Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy

ANKA-HR
Start date: July 5, 2017
Phase: N/A
Study type: Interventional

This study will measure the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue in high risk subjects (Quebec risk categories P2, P3 and P4) scheduled for colonoscopy.

NCT ID: NCT03247244 Terminated - Tourette Syndrome Clinical Trials

Safety and Efficacy of Cannabis in Tourette Syndrome

Start date: January 15, 2018
Phase: Phase 2
Study type: Interventional

For many individuals with Tourette syndrome (TS), available medications do not help with their symptoms, or cause significant side effects. Two small controlled trials have investigated the effect of oral delta-9-tetrahydrocannabinol (THC), a principal psychoactive ingredient of cannabis, in TS patients. While these trials have shown promising results, the effect sizes were not as large and consistent as those reported by patients with regards to inhaled cannabis (smoked or vaporized). Indeed, based on anecdotal evidence, patients have much greater improvement in their symptoms using inhaled cannabis than using cannabinoid pharmaceuticals. However, there have been no controlled trials of inhaled medical cannabis for TS to date. Furthermore, various medical cannabis products are authorized in Canada with different contents of THC and cannabidiol (CBD), another primary cannabinoid. No data exists regarding the dosing, efficacy and safety of these products in the treatment of TS. To gather such data, a double-blind, randomized, crossover pilot trial will be conducted to compare the efficacy and safety of three vaporized medical cannabis products with different THC and CBD contents, as well as placebo, in adults with TS. As well, the PK/PD profile of THC and CBD of the products will be assessed and correlated with tic symptoms

NCT ID: NCT03247023 Terminated - Clinical trials for Rheumatoid Arthritis

Long Term Follow-up of Integra® Cadenceā„¢ Total Ankle System in Primary Ankle Joint Replacement

Start date: September 18, 2017
Phase:
Study type: Observational

This study will evaluate the long term performance and safety data for the Cadenceā„¢ Total Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)

NCT ID: NCT03242265 Terminated - Prostatic Neoplasm Clinical Trials

Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy

ANKA-PCA
Start date: April 4, 2017
Phase: N/A
Study type: Interventional

This study will look at measuring the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue in subjects being screened for prostate cancer using prostate biopsy.