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NCT ID: NCT01809665 Completed - Clinical trials for Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs

ProMRI PROVEN Master Study

Start date: June 2013
Phase: N/A
Study type: Observational

This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.

NCT ID: NCT01809327 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

Start date: June 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.

NCT ID: NCT01807923 Completed - Clinical trials for Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

TRAFFIC
Start date: May 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

NCT ID: NCT01807039 Completed - Clinical trials for Fracture of Neck of Femur (Hip)

Mortality Following Surgery for Proximal Femoral Fractures

HipMo
Start date: December 2012
Phase: N/A
Study type: Observational

Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses undergoing surgery. It affect most seniors and accompanied by a series of complications. The aim of our retrospective clinical trial is to establish a thirty-day mortality rate after surgical solutions, mortality during hospitalization and compare the types of anesthesia chosen during the performance (general vs. subarachnoid anesthesia).

NCT ID: NCT01798485 Terminated - Clinical trials for Non-small Cell Lung Cancer Metastatic

A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC

Galaxy 2
Start date: March 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

NCT ID: NCT01795872 Completed - Multiple Sclerosis Clinical Trials

Follow-up Study After 11 Years of Patients Who Were Included in the BENEFIT Trial (304747) With a First Demyelinating Event Suggestive of Multiple Sclerosis

Start date: September 2013
Phase: Phase 4
Study type: Interventional

This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.

NCT ID: NCT01794663 Completed - Clinical trials for Delayed Graft Function

Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function

Start date: October 2012
Phase: Phase 2
Study type: Interventional

When a patient receives a kidney transplant particularly if the kidney is from an older donor or one who has had the kidney removed after their heart has stopped, there is a risk that the newly transplanted kidney may not function immediately. If the delay in function means that dialysis is needed in the first 7 days after the transplantation then this is known as delayed graft function or dDGF. Also delayed graft function that does not require dialysis but is present because the serum creatinine does not fall sufficiently is known as functional delayed graft function or fDGF. This problem is often due to an excessive inflammatory reaction to not having had a blood supply between the time of donation and transplant. OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be partly responsible for increasing the risk of this inflammation. It is hoped that the effects of the inflammation will be reduced and therefore prevent dDGF and fDGF from occurring. The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF as well as improving other measures of kidney function and the overall safety of the antibody. In the first part of the study, each patient received an Infusion of one of three possible doses of OPN-305 or a placebo and in the second part the most suitable dose of OPN-305 and a placebo would be used. The purpose of this second part of the study is to find out if a dose of OPN-305 which has already been tested in an earlier part of this study can prevent kidney graft dysfunction. For the purposes of this study, kidney function will be assessed using the composite of delayed graft function (dDGF) because dialysis is necessary in the first 7 days and functional delayed graft function that does not require dialysis but is present because the serum creatinine, a key measure of renal function, does not fall sufficiently (fDGF) in the first 7 days post-transplant. Protocol OPN305-103 follows out to 12 months post-transplant the clinical status and graft function of patients who have completed the 6-month post-transplant period under Part A or Part B of OPN305-102.

NCT ID: NCT01786668 Completed - Clinical trials for Ankylosing Spondylitis

Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

Start date: April 2013
Phase: Phase 2
Study type: Interventional

This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.

NCT ID: NCT01784562 No longer available - Clinical trials for Hypertension, Pulmonary

Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

EAS
Start date: n/a
Phase: N/A
Study type: Expanded Access

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

NCT ID: NCT01783158 Completed - Clinical trials for Squamous Cell Carcinomas of the Head and Neck

Chromoendoscopy to Detect Early Synchronous Second Primary Esophageal Carcinoma

HNSCC
Start date: January 2004
Phase: N/A
Study type: Observational

Patients with HNSCC represent a high-risk group for the development of SESCC. Thus, esophagogastrofibroscopy should be performed to detect possible synchronous esophageal carcinomas in these patients. Although only two patients with synchronous primary carcinomas were found among the patients with newly diagnosed HNSCC in this study, esophagoscopy and better some of advanced endoscopic methods should be recommended after detection of HNSCC to exclude secondary esophageal carcinoma or dysplasia. Staining of the esophagus with Lugol's solution is an easy and inexpensive option and can be done in most of gastroenterology offices.