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NCT ID: NCT01968213 Completed - Ovarian Cancer Clinical Trials

Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)

ARIEL3
Start date: April 7, 2014
Phase: Phase 3
Study type: Interventional

Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

NCT ID: NCT01968031 Completed - Clinical trials for Idiopathic Parkinson's Disease

A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

KW-6002
Start date: October 2013
Phase: Phase 3
Study type: Interventional

This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.

NCT ID: NCT01967888 Completed - Clinical trials for Pancreatectomy for Chronic Pancreatitis

Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation

Start date: February 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The study is a phase 2/3, multicenter, double-blind, parallel assignment study. It involves 100 adult recipients of an intra-hepatic pancreatic Islet Auto-Transplantation (IAT). The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by the proportion of insulin-independent patients following IAT. The safety of reparixin in the specific clinical setting will be also evaluated.

NCT ID: NCT01967797 Completed - Clinical trials for Overweight and Obesity

Implementation and Validation of the "5As Framework of Obesity Management" in Primary Care. "5AsT"

5AsT
Start date: October 21, 2013
Phase: N/A
Study type: Interventional

The main goal of this project is to develop, implement and evaluate the 5As Team intervention (5AsT)for healthcare practitioners to improve their weight management patient encounters and improve patient health outcomes. The 5As of Obesity Management suite of tools is a robust, evidence-based approach to weight management, however its implementation and uptake has been heterogeneous in primary care. This project was co-created by, and will be implemented with, our partners the Southside Primary Care Network (SSPCN). A needs assessment on weight management by the SSPCN revealed the need to change provider practice to increase the number of weight management visits. Despite a robust didactic training session on weight management for all providers, which includes the 5As, the uptake in practice has been highly heterogeneous. Thus, the 5AsT intervention to address the implementation of the 5As of Obesity Management in clinical practice was developed by the collaborative team. The SSPCN consists of 25 autonomous groups of multidisciplinary professionals that provide service to a defined group of patients within the SSPCN. The 5As Team consists of multidisciplinary providers (Registered Nurse/ Nurse Practitioner, dietician, mental health worker) who work collaboratively. The intervention is a learning collaborative where these 12 different 5AsTs get together to work to address facilitators and barriers to weight management in their settings over a 6 month period. Half of the teams (N=12) will remain as controls and deliver usual care. They serve as a comparison group for the 5AsTs. This mixed methods study's primary outcomes will assess the change in provider practice and the effectiveness of the intervention and implementation. To assess the impact of 5AsT on patients, we will recruit patients presenting to the central SSPCN programming, We will not intervene directly on patients; we will observe the impact of the 5AsT and SSPCN programming on their health outcomes for a minimum of 6 months, and where possible for 18 months. Data collected includes demographics, weight (BMI), waist circumference, vital signs,and Short Form-12 (SF-12,these measures are routinely measured in the SSPCN), EuroQol-5 dimensions 5 Level (EQ-5D-5L), modified patient assessment of chronic illness (PACIC), and observed adherence to routine clinical care for guideline recommended laboratory monitoring (cholesterol panel, fasting glucose, HbA1c, where appropriate).

NCT ID: NCT01967329 Completed - Clinical trials for Helicobacter Pylori Infection

CANHelp Working Group Treatment Trials

Start date: November 2008
Phase: Phase 4
Study type: Interventional

The CANHelp Working Group Treatment Trials are part of a comprehensive research program carried out by the Canadian North Helicobacter pylori (CANHelp) Working Group. The treatment component involves a series of community-specific trials designed with community input and varying on the specific treatment regimens and number of treatment arms among other study details.

NCT ID: NCT01966614 Completed - Clinical trials for Benign Prostatic Hyperplasia

Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH

PLUS-1
Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.

NCT ID: NCT01966601 Completed - Clinical trials for Acute Decompensated Heart Failure

A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure

BLAST-AHF
Start date: December 2013
Phase: Phase 2
Study type: Interventional

To evaluate the overall safety and efficacy of TRV027 when administered in addition to standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients hospitalized with Acute Decompensated Heart Failure (ADHF).

NCT ID: NCT01966471 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

Start date: January 31, 2014
Phase: Phase 3
Study type: Interventional

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

NCT ID: NCT01966393 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults With Type 1 Diabetes

Start date: April 2014
Phase: Phase 2
Study type: Interventional

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes. The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional pump therapy.

NCT ID: NCT01966107 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.

ASCENT COPD
Start date: October 16, 2013
Phase: Phase 4
Study type: Interventional

The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.