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NCT ID: NCT02441283 Completed - Hepatitis C Clinical Trials

A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530

Start date: June 22, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.

NCT ID: NCT02439749 Completed - Hypertension Clinical Trials

SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.

NCT ID: NCT02439710 Completed - Hemophilia Clinical Trials

Patient Reported Outcomes Burdens and Experiences - Phase 2

PROBE
Start date: June 2015
Phase:
Study type: Observational [Patient Registry]

The Patient Reported Outcomes, Burdens, and Experiences (PROBE) Study aims to develop a new global tool to enhance the direct patient-voice in health care decision-making. Government and private payers increasingly value data based on patient-centered outcomes research as part of the overall cost-benefit evaluation of high-cost care and treatment of diseases such as hemophilia. This emerging dimension of the healthcare environment presents a significant opportunity and urgent need to improve patient organizations' ability to collect and interpret relevant outcomes data. More robust patient reported data will improve advocacy efforts to build comprehensive care programs, promote home treatment and implement preventative treatment regimens thus allowing advocacy arguments to move beyond emotion and anecdote to those grounded in real-world patient experiences and evidence. With the support of the National Hemophilia Foundation, a global team of investigators will lead a patient focused research project to investigate and directly probe patient perspectives on outcomes they deem relevant to their care. Through PROBE, the investigators will develop and seek to validate the reliability, reproducibility and responsiveness of a low cost, easily administrable inventory for collecting patient self-reported outcomes, burdens and experiences in living with hemophilia. The investigators anticipate that the metrics established through PROBE will allow for comparison of patient outcomes within a country over time and cross-sectionally between countries (regionally and globally).

NCT ID: NCT02439671 Completed - Clinical trials for Autism Spectrum Disorder

Transition Support Program for Young Adults With Autism Spectrum Disorders

Start date: May 2012
Phase: N/A
Study type: Interventional

This study investigates a service delivery model to better support young adults with autism spectrum disorders (ASD) in the transition from school to the community. The effectiveness of the "McGill Transition Support Program", a small-group format intervention (meeting once a week for 2 hours over 10 weeks) focusing on communication, self-determination and working with others skills, is measured by multiple pre- and post-program-assessments in a "staggered enrollment trial", a variant of a randomized controlled trial (RCT).

NCT ID: NCT02438826 Completed - Clinical trials for Chronic Cluster Headache

A Study of Galcanezumab in Participants With Chronic Cluster Headache

Start date: June 18, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

NCT ID: NCT02438813 Completed - Submental Fullness Clinical Trials

Condition of Submental Fullness and Treatment Outcomes Registry

CONTOUR
Start date: May 11, 2015
Phase:
Study type: Observational [Patient Registry]

The primary objective of this registry is to develop a comprehensive understanding of the condition of submental (SM) fullness due to submental fat (SMF), how it is treated in current clinical practice, and the risks and benefits associated with its treatment.

NCT ID: NCT02438449 Completed - Breast Cancer Clinical Trials

Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study

Start date: July 2015
Phase:
Study type: Observational

It is estimated that about 25% and 40% of health care expenditures in Canada and USA respectively are wasted because of inefficiencies and not practicing evidence-based medicine. As health care resources are scarce it behooves all of us to use these in a cost-effective manner. The term "cost-effective" is used in the health care literature often but erroneously. Investigators compare a "novel' intervention to a "prevailing" one and if the novel intervention is less costly it is labeled "cost-effective". In a methodologically correct cost-effectiveness study however, investigators need to integrate both the effectiveness and costs of the competing interventions and calculate an incremental cost-effective ratio. If this ratio falls within acceptability thresholds, the novel intervention is labeled cost-effective. There are many techniques of breast reconstruction. The two most common approaches are the Autologous Abdominal Tissue (AAT) and the Tissue Expansion / Implant reconstructions. In this study these two most common breast reconstruction approaches after mastectomy due to cancer performed in the Hamilton/Niagara/Haldimand/Brant and Waterloo/Wellington LHINs will be investigated with a cost-effectiveness analysis coupled with a methodologically robust observational study.

NCT ID: NCT02438332 Completed - Breast Implantation Clinical Trials

Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants

RANBI-I
Start date: December 2014
Phase: N/A
Study type: Observational

This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.

NCT ID: NCT02438280 Completed - Malocclusion Clinical Trials

Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project

Start date: May 2015
Phase: N/A
Study type: Interventional

The AcceleDent® device has been introduced to the specialty of orthodontics in order to reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth movement to occur more quickly. Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort during orthodontic treatment. This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.

NCT ID: NCT02438189 Completed - Type 1 Diabetes Clinical Trials

Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms

PHM2
Start date: June 2015
Phase: Phase 2
Study type: Interventional

Objective: to gain experience with in-home use of a modified algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data. Study Design: randomized controlled trial, with randomization on a night level within subject. Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months; 15.0 to <46.0 years of age; HbA1c < 10.0%; no DKA in last 6 months; no hypoglycemic seizure or loss of consciousness in last 6 months; Living with a significant other or family member ("companion") committed to participating in all study activities, and being present and available to provide assistance when the system is being used at night. Sample Size: 30 subjects. Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use. Major Efficacy Outcomes: - Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight. - Secondary: time spent in hypoglycemia (≤70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight. Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis.