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NCT ID: NCT03021915 Suspended - Clinical trials for Primary Ovarian Insufficiency

Single Center, Prospective Controlled Pilot Study of the OvaPrime Procedure

Start date: October 2016
Phase: N/A
Study type: Interventional

This is a single center, prospective, controlled pilot safety research study. The primary objective of this research study is to assess the safety with the use of the OvaPrime procedure in women who are diagnosed with either primary ovarian insufficiency (POI) or poor ovarian response (POR). A maximum of ninety-five (95) subjects will be enrolled consisting of a minimum of thirty (30) POI subjects and a minimum of fifty (50) POR to achieve the target sample size of 70 Modified Intent-to-Treat (mITT) subjects as the primary analysis population. Each subject shall have one ovary exposed to the EggPC cells while the contralateral ovary is exposed to the EggPC vehicle as a means to have each subject serve as their own control. Results between the treatment and control ovary will be examined for relevant endpoints such as antral follicle counts. The duration of the research study is estimated at approximately 6 years total, for the period spanning enrollment (estimated at approximately six months), eight months to the last hyperstimulation and through completion of 5-year follow-up (main study protocol with one year primary endpoint and LTFU sub-study which extends to 5 additional years).

NCT ID: NCT02769130 Suspended - Children Clinical Trials

Pilot Trial: the Safety and Feasibility of Losartan for Pulmonary Vein Stenosis

Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This pilot study evaluates the safety and feasibility of losartan in pediatric patients with pulmonary vein stenosis. It is an open label single arm interventional study. The patient population involves pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given losartan for 1 year. Outcomes include measures of safety/adverse events and progression of pulmonary vein stenosis.

NCT ID: NCT02579005 Suspended - Lung Cancer Clinical Trials

Radio-Immuno-Modulation in Lung Cancer

RIM
Start date: April 20, 2018
Phase: Phase 1
Study type: Interventional

This project will assess the feasibility of treating advanced cancer using the immune system, without any anti-cancer drug. In this pilot study, the investigators propose combining low-dose radiotherapy, in lung cancer patients, with allogeneic immune cells obtained from a donor. The patients will receive radiotherapy directed to one of the patient's tumors, as well as an immunomodulatory drug called cyclophosphamide. Thereafter, they will receive the infusion of donor immune cells.

NCT ID: NCT02546102 Suspended - Clinical trials for Glioblastoma Multiforme

Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma

Start date: December 2024
Phase: Phase 3
Study type: Interventional

ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.

NCT ID: NCT02528487 Suspended - Clinical trials for Chronic Obstructive Pulmonary Disease

Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?

Start date: May 2015
Phase:
Study type: Observational

The present study aims to assess the prevalence and impact of comorbid psychiatric disorders among patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation (PR), in order to determine the effects of psychiatric comorbidity on exercise tolerance and physical activity post-PR and HRQoL, as well as to determine the processes by which these psychiatric disorders may impact on these patient behaviours.

NCT ID: NCT02432989 Suspended - Brain Concussion Clinical Trials

Establishing Early Exercise Interventions in Concussion Recovery

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

This is a Phase 1 study to determine (1) the safety of an exercise protocol in adolescents and young adults with concussion in the first week post-injury and (2) to evaluate the effects of mild symptoms on brain function using EEG. This pilot study will inform subsequent grant applications, and a Phase II randomized control trial that will explore the influence of age on an early re-introduction to exercise, as well as the influence of varying intensity levels of exercise.

NCT ID: NCT02420522 Suspended - Clinical trials for Mild Cognitive Impairment

Magnetic Brain Stimulation in the Treatment of Mild Cognitive Impairment

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

This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). The main objective of this study is to investigate the ability of rTMS to produce cognitive improvement in individuals with MCI. A secondary objective is to determine whether individuals with MCI following mild brain trauma respond differently to rTMS treatment compared to individuals with non-trauma related MCI. Participants will undergo both active and sham (placebo) rTMS treatment. Cognitive and psychological assessments will be administered before and after each week of rTMS therapy, for both active and sham conditions. Cognitive testing will include verbal, semantic, logic, visual, conceptual, and memory tasks.

NCT ID: NCT02275858 Suspended - Clinical trials for Small Bowel Diseases

Enteroscopy Stiffening Device for Retrograde Balloon Assisted Enteroscopy

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

Balloon assisted enteroscopy has revolutionized the management of small bowel diseases by enabling endoscopic access deep into the small bowel. Using a combination of antegrade (through the mouth) and retrograde (through the anus) approaches, a large portion of the small bowel can be examined. Access to the proximal small bowel through the pylorus using the antegrade approach is straightforward but intubating the distal small bowel through the ileocecal valve is challenging due to the flexibility of the enteroscope. Recently, an enteroscopy stiffening wire has been developed. The purpose of our double blind placebo controlled randomized cross over study is to evaluate the performance of the enteroscopy stiffening wire in achieving terminal ileum intubation (TI) during retrograde balloon assisted enteroscopy.

NCT ID: NCT02157532 Suspended - Stroke, Acute Clinical Trials

Endovascular Acute Stroke Intervention Trial - the EASI Trial

EASI
Start date: January 2013
Phase: N/A
Study type: Interventional

Stroke constitutes the primary cause of acquired disability in adults and the second cause of dementia following Alzheimer disease. It has been shown that patients with a moderate to severe clinical score have occlusion of brain large vessels, resulting in a worse clinical outcome. Many studies have demonstrated that early recanalization after IV rtPA is more restricted, the larger and more proximal the artery. Several systems for mechanical intracranial arterial thrombectomy of large trunks have recently been proposed and are now available. Potential advantages of these mechanical systems on chemical thrombolysis are speed (a few minutes versus 1 hour) and absence of thrombolytic injection. The objective of the EASI trial is thus to: - To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in patients treated with IV thrombolysis or in patients for whom thrombolysis is contra-indicated. - To determine whether a combined approach, standard treatment plus thrombectomy, is superior to standard treatment alone within 5 h of the appearance of symptoms, in patients with occlusion of proximal cerebral arteries following moderate to severe stroke (NIHSS larger than or equal to 8), evaluated at 3 months. The design is a randomized, controlled multicentric trial, with a parallel comparison between standard and combined (standard plus thrombectomy) treatment. 480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or equal to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment at 3 months. IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is carried out with already approved devices, according to the manufacturer's instructions, following a diagnostic cerebral angiography. The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3 months. The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage at 24 hours. If the primary hypothesis is validated, expected benefits of this study is a higher rate of autonomy for stroke patients with all the attendant consequences: reduction in hospital stays, and a faster return to the activities of daily life.

NCT ID: NCT02142998 Suspended - GERD Clinical Trials

A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring

GERD
Start date: October 2014
Phase: N/A
Study type: Interventional

Obesity has become a significant health problem in Canada. It is known to be a risk factor for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts to lose weight fail, patients often consider bariatric surgical procedures as the next step. The two most common bariatric procedures performed are Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG). The gold standard for diagnosing GERD is Esophageal pH monitoring, as it is the most objective method to document the reflux, assess the severity and monitor the response to treatment of the disease. In the last few years LSG has gained in popularity due to its simplicity and short operative time. Currently the comparison between bariatric surgery and GERD symptoms is very one sided. There are significant numbers of studies with conclusive results that state that LRYGB has a positive effect on GERD symptoms, however there is little evidence that states the same about LSG. This means that the relationship between LSG and GERD is inconclusive. An objective evaluation of GERD using 24 hour pH monitoring and validated CRFs at different follow up time points will contribute greatly to our understanding of what this relationship might be.