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NCT ID: NCT02160145 Completed - Clinical trials for Chronic Kidney Disease

Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Start date: May 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)

NCT ID: NCT02159638 Completed - Clinical trials for Diabetes Mellitus, Type 1

Accuracy of Two CGM Systems Tested Simultaneously in Ambulatory Patients With Type 1 Diabetes

Start date: May 2013
Phase: N/A
Study type: Interventional

Continuous glucose monitoring (CGM) is a tool used in the treatment of patients with type 1 diabetes. A continuous glucose monitor (CGM) is a subcutaneous tissue sensor, which provides a tissue fluid glucose measurement every 1 to 5 minutes. Since CGM measure the glucose level by a sensor in subcutaneous tissue, there is uncertainty in the estimation of blood glucose levels. The accuracy of a certain CGM system can be assessed by comparing the glucose levels estimated by CGM with measured glucose levels in plasma. In the current study, we will compare the accuracy of the 2 CGM systems available on the market for clinical use in patients with type 1 diabetes. The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction with 2 different CGM systems among adult type 1 diabetic patients.

NCT ID: NCT02158936 Terminated - Thrombocytopaenia Clinical Trials

A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Start date: June 10, 2014
Phase: Phase 3
Study type: Interventional

Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

NCT ID: NCT02158923 Recruiting - Clinical trials for Moderated-high Risk of Postoperative Pulmonary Complication

Individualized Perioperative Open Lung Ventilatory Strategy

iPROVE
Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and postoperative individualized ventilatory support will decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all patients at risk.

NCT ID: NCT02158455 Active, not recruiting - Angina Pectoris Clinical Trials

Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery

Start date: February 2004
Phase: N/A
Study type: Interventional

The investigators have developed a novel technique for saphenous vein graft harvesting for coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein grafts harvested with this new methode compared to conventional harvesting technique 8.5 years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized trial comparing patency between vein grafts harvested with surrounding tissue and radial artery grafts. The result showed that vein grafts harvested with surrounding tissue had a significantly higher patency rate compared to radial artery grafts 3 years after surgery (98 vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in the second randomized trial. The hypothesis is that vein grafts harvested with surrounding tissue have a significantly higher patency rate compared to radial artery grafts 8 years after surgery.

NCT ID: NCT02158286 Completed - Esophagectomy Clinical Trials

Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet

Start date: January 2012
Phase: N/A
Study type: Observational

Retention of the gastric tube after esophagectomy is a clinically important problem, and there is a need of a simple method to evaluate emptying rate from the gastric tube after esophagectomy. Scintigraphy is the golden standard of measuring emptying rate from the gastric tube. In non-operated patients, paracetamol clearance technique have been widely used for measuring gastric emptying rate. There is no validation however if paracetamol clearance technique can be used for measuring emptying rate of the gastric tube. The investigators aim of this pilot- study is to validate paracetamol clearance technique to scintigraphy for measuring emptying rate from the gastric tube and to evaluate if there is a correlation between symptoms of retention and quality of life with the emptying rate.

NCT ID: NCT02157922 Completed - Cystic Fibrosis Clinical Trials

A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis

SMR-2984
Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis.

NCT ID: NCT02156804 Completed - Melanoma Clinical Trials

A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)

Start date: October 7, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.

NCT ID: NCT02155660 Completed - Clinical trials for Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

TERRANOVA
Start date: June 25, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.

NCT ID: NCT02154620 Completed - Clinical trials for Distal Radius Fracture

Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster

70
Start date: April 2013
Phase: N/A
Study type: Interventional

Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination. An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study. A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.