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NCT ID: NCT02478060 Completed - Rhinitis Clinical Trials

Birch-SPIRE Safety and Efficacy Study

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.

NCT ID: NCT02477618 Completed - Clinical trials for Super-Refractory Status Epilepticus

A Study With SAGE-547 for Super-Refractory Status Epilepticus

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

This is a randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to subjects in Super-Refractory Status Epilepticus (SRSE).

NCT ID: NCT02477488 Completed - Renal Insufficiency Clinical Trials

Optimal Administration of Allopurinol in Dialysis Patients

Start date: June 2015
Phase: Phase 4
Study type: Interventional

Gout has a strong association with the metabolic syndrome, and it is often seen in patients with renal insufficiency. Allopurinol is a medication intended to lower uric acid and therefore prevents gout attacks. Its metabolism is mainly renal, and some evidence shows that it is also dialyzable. The hypothesis is that allopurinol would be more efficacious to lower uric acid if it was given after dialysis only. The investigators will then switch administration of allopurinol to bedtime for dialysis patients currently taking that medication.

NCT ID: NCT02477332 Completed - Clinical trials for Chronic Spontaneous Urticaria

Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Start date: July 15, 2015
Phase: Phase 2
Study type: Interventional

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.

NCT ID: NCT02477072 Completed - Clinical trials for Peripheral Revascularisation

Optimized Heparin Regimen in Vascular Surgery

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

Hypothesis: Optimal anticoagulation defined as an Activated Clotting Time (ACT) of 300 to 350 seconds obtained by weight-adjusted doses of unfractionated heparin (UFH) will improve the hemostatic environment downstream from the vascular clamp, provide better blood flow in the distal bed following peripheral revascularization surgery. Objectives: This study is designed to assess the effects of an optimized regimen of UFH on the hemostatic environment downstream from the vascular clamp in major vascular surgery.

NCT ID: NCT02476968 Completed - Clinical trials for BRCA or HRR+ Mutated Ovarian Cancer Patients

To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer

ORZORA
Start date: September 28, 2015
Phase: Phase 4
Study type: Interventional

This is a prospective, open-label, single arm, multi-center study to assess the real world clinical effectiveness and safety of olaparib maintenance monotherapy as the capsule formulation (in line with the EU approved prescribing information) and will be conducted in platinum-sensitive relapsed high grade epithelial ovarian cancer patients (including patients with primary peritoneal and / or fallopian tube cancer) who carry germline or somatic BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious [known or predicted to be detrimental/lead to loss of function]).

NCT ID: NCT02476760 Completed - Clinical trials for Diabetes Mellitus, Type 2

Incretin-based Drugs and Acute Pancreatitis

Start date: March 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone or in combination with other anti-diabetic drugs are associated with an increased risk of acute pancreatitis (AP) compared to other combinations of oral hypoglycemic agents (OHA). The investigators will carry out separate population based cohort studies using administrative health databases in six jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for AP. The results from the separate sites will be combined to provide an overall assessment of the risk of AP in users of incretin-based drugs and by class of incretin-based drugs.

NCT ID: NCT02476279 Completed - Clinical trials for Post-ERCP Pancreatitis

Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis

SVI
Start date: September 2015
Phase: Phase 3
Study type: Interventional

Background: Pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality, and increased health care expenditures. Until recently, the only effective method of preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement (PSP), an intervention that is costly, time consuming, technically challenging, and potentially dangerous. The investigators recently reported the results of a large randomized controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (>80%) had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who received indomethacin alone were less likely to develop PEP than those who received a pancreatic stent alone or the combination of indomethacin and stent, even after adjusting for underlying differences in subject risk. If indomethacin were to obviate the need for PSP, major clinical and cost benefits in ERCP practice could be realized. Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP pancreatitis in high-risk cases. Methods: Comparative effectiveness multi-center non-inferiority trial of rectal indomethacin alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four hundred and thirty subjects at elevated risk for PEP who would normally receive a pancreatic stent for prophylaxis will be randomized to indomethacin alone or the combination of indomethacin and PSP. The proportion of patients developing PEP and moderate-severe PEP will be compared. In addition, the investigators will establish a quality-assured central repository of biological specimens obtained from study participants, permitting future translational research elucidating the molecular and genetic mechanisms of PEP, as well as the mechanisms by which non-steroidal anti-inflammatory drugs prevent this complication.

NCT ID: NCT02476266 Completed - Parkinson's Disease Clinical Trials

Two Resistance Training Protocols to Reduce the Risk of Falls in Parkinson's Disease

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

Parkinson's disease (PD) is a chronic neurodegenerative disorder that is characterized by a multitude of symptoms. Impairments in balance, muscle deficits and increased risk of falls are commonly experienced in PD.The purpose of this study is to investigate the effects of two different resistance training programs on improving balance and muscular strength to thereby reduce the risk of falls in those with PD. This study will randomize individuals to one of two groups, a power training group, or a strength training group. Both interventional groups will participate in 12 weeks of resistance training, two times per week for an hour each exercise session.

NCT ID: NCT02476006 Completed - Clinical trials for Hypercholesterolemia

Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Start date: June 23, 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population. Secondary Objectives: To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment. To document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).