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NCT ID: NCT00737880 Completed - Diabetes Mellitus Clinical Trials

Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion in Clinical Pancreas Transplantation

Start date: July 2001
Phase: Phase 4
Study type: Interventional

Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by topic cooling and cold in situ flushing using special perfusion solutions designed to attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance. For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly used perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK) solution has been increasingly used for abdominal organ procurement. Retrospective reports published so far have demonstrated the safety of both perfusion solutions. However, to date, no prospective study comparing both perfusion solutions has been published. Aim of this study was to prospectively evaluate early pancreas graft function in clinical pancreas transplantation after organ perfusion with HTK vs. UW solution. The study hypothesis is that HTK is not inferior to UW for organ perfusion during procurement in clinical pancreas transplantation.

NCT ID: NCT00737568 Completed - Hepatitis B Clinical Trials

Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine

Start date: September 2008
Phase: Phase 3
Study type: Interventional

The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain suppression of viral replication to prevent the emergence of complications, which requires long-term therapy. Durable suppression of viral replication is achieved in the treatment of chronic viral diseases by preventing of the emergence of drug-resistant mutations. The clinical guidelines for the management of lamivudine resistant patients are variable. Some recommend switching to another agent without cross-resistance, while others recommend adding on another agent without cross-resistance. Limited clinical data exists to demonstrate whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for lamivudine resistant patients or if it should be used as part of a combination therapy regimen. This study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or without the rtL180M mutation) over a 240-week period. Participants in this study must be receiving lamivudine treatment at the time of enrollment.

NCT ID: NCT00737529 Completed - Clinical trials for Mantle Cell Lymphoma

A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial

EMERGE
Start date: December 22, 2008
Phase: Phase 2
Study type: Interventional

To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

NCT ID: NCT00736502 Completed - HIV Infections Clinical Trials

PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.

Start date: September 2008
Phase: N/A
Study type: Observational

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.

NCT ID: NCT00736151 Completed - Neuropathic Pain Clinical Trials

Phase II Dose Titration Study in Patients With Neuropathic Pain

Start date: May 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the effects of various increasing doses of Ralfinamide in patients with neuropathic pain.

NCT ID: NCT00736099 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment. The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)

NCT ID: NCT00735397 Completed - Epilepsy Clinical Trials

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

NCT ID: NCT00735163 Completed - Critical Illness Clinical Trials

Blood Glucose Control With A Software-Algorithm In Intensive Care Unit (ICU) Patients

Aldea _01
Start date: September 2008
Phase: N/A
Study type: Interventional

Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Recently, large randomized controlled trials have demonstrated that tight glycaemic control (TGC) reduces morbidity and mortality in this population. Based on this emerging evidence intensive insulin therapy is currently finding its way into the critical care practice. In the meantime numerous insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented. Recent reviews comparing different types of protocols describe widely ranging practice and difficulties in achieving TGC despite extensive efforts of the intensive care unit (ICU) staff. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. The primary objective of the current study is to investigate the performance (efficacy) of a control algorithm for glycaemic control in ICU patients for the whole length of ICU stay.

NCT ID: NCT00735137 Completed - Preterm Birth Clinical Trials

Randomized Study of Pessary Versus Standard Management in Women With Increased Chance of Premature Birth

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine the effect of cerclage pessary on the incidence of spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic women with singleton pregnancies found at routine mid-trimester screening to have a cervix of <25 mm in length and in twin pregnancies.

NCT ID: NCT00734747 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)

Start date: May 2008
Phase: Phase 3
Study type: Interventional

The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD. The system allows the operator to staple the stomach to the esophagus,in order to restore the gastroesophageal flap valve. The effect of the stapling is similar to a common operation for GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is not needed. The hypothesis of the study is that the treatment will be effective in improving GERD related quality of life by 50% or more in the majority of the subjects, and that the procedure will be as safe as surgery.