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NCT ID: NCT01126749 Terminated - Bladder Cancer Clinical Trials

Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer

Start date: April 16, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether Patients with Locally Advanced or Metastatic Bladder Cancer who receive Eribulin Mesylate Administered in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy is safety and tolerable when administered to patients with locally advanced or metastatic bladder cancer and to gain preliminary data on whether patients may benefit from this combination.

NCT ID: NCT01124227 Terminated - Clinical trials for Congestive Heart Failure

Peritoneal Dialysis in Congestive Heart Failure

PDinCHF
Start date: April 2010
Phase: Phase 3
Study type: Interventional

Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme. Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy.. Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF < 30%, older than 18 years). Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®). Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).

NCT ID: NCT01118728 Terminated - Clinical trials for Ankylosing Spondylitis

Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

SUSTAIN
Start date: June 2010
Phase: Phase 2
Study type: Interventional

Primary Objective: - To assess the long term safety of Sarilumab (SAR153191/REGN88) in patients with ankylosing spondylitis (AS) Secondary Objective: - To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in patients with AS

NCT ID: NCT01117987 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

IMPRES Extn
Start date: April 2010
Phase: Phase 3
Study type: Interventional

This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

NCT ID: NCT01116557 Terminated - Atrial Fibrillation Clinical Trials

Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)

CLARITY-AF
Start date: April 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.

NCT ID: NCT01110070 Terminated - Cartilage Defect Clinical Trials

ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee

Start date: July 2010
Phase: N/A
Study type: Interventional

The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.

NCT ID: NCT01107184 Terminated - Atrial Fibrillation Clinical Trials

Remote Ischemic Conditioning and Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)

RICO
Start date: January 2010
Phase: N/A
Study type: Interventional

Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.

NCT ID: NCT01092312 Terminated - Clinical trials for Arthroplasty, Replacement, Knee

Signature Personalised Patient Care System With the Vanguard Knee System Study

Start date: March 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.

NCT ID: NCT01088334 Terminated - Clinical trials for Venous Thromboembolism

Mortality Due to Malignancy in Patients With Idiopathic Venous Thromboembolism

Trousseau
Start date: December 2002
Phase: N/A
Study type: Observational

Background Patients with an idiopathic venous thromboembolism (IVTE) appear to have a risk of approximately 10% for symptomatic malignancy within 3 years after the IVTE. It is not clear if extensive screening for malignant disease leads to survival benefit in patients with an IVTE. The SOMIT study learned that it is feasible to screen patients with an IVTE for malignancy and screening by means of a computer tomography (CT) of the chest and abdomen plus a mammography in women had the potential to be most cost-effective. The SOMIT study could not show a survival benefit due to the design of the study. Primary objective: cancer related mortality Methods: The Trousseau study has been designed as a multicenter, prospective concurrently controlled cohort study. Inclusion criteria: 1. Proven first symptomatic deep venous thromboembolic event; 2. Without: known risk factor for venous thromboembolism. Exclusion criteria: 1. Proven deep venous thromboembolic event in the medical history, age under 40 years; 2. Patients without signs of malignancy after routine investigations (medical history, physical examination, laboratory investigations and chest X-ray) were included. Depending on the standard care in the hospital of interest, one group of patients has been screened by means of CT-chest and abdomen plus mammography, the other group had no additional investigations. Follow-up was aimed to be 3 years in both groups (at 3, 6, 12, 24 and 36 months after the thromboembolic event). Data like mortality rate, morbidity due to screening procedures, additional investigations, number of cancer patients detected by the extensive screening, number of cancer patients three years after the IVTE, number and kind of investigations performed and information about cancer treatment and hospitalization was collected. If this information indicate a survival benefit these data enable us to perform a cost-effectiveness analysis. Endpoint: Mortality. Statistics: Based on the prevalence of occult malignancy in VTE patients, the nature and stage of malignancies, the expected mortality, the anticipated detection of cancers and the early treatment related decrease in mortality we needed, in order to detect a true difference of this size with a 80 percent power and a two-tailed certainty of five percent, 750 patients for each group. Therefore, a total of 1500 patients is required for this study.

NCT ID: NCT01083472 Terminated - Hernia Clinical Trials

Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)

StAR
Start date: March 2010
Phase: Phase 4
Study type: Interventional

The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.