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NCT ID: NCT01375127 Completed - Clinical trials for Kidney Transplantation

Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

Start date: August 2011
Phase: N/A
Study type: Observational

This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.

NCT ID: NCT01375049 Completed - Cystic Fibrosis Clinical Trials

Aztreonam Lysine for Pseudomonas Infection Eradication Study

ALPINE
Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA. The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).

NCT ID: NCT01374906 Completed - Cushing's Disease Clinical Trials

Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

Start date: November 4, 2011
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

NCT ID: NCT01374451 Completed - Islet Cell Tumor Clinical Trials

Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET

COOPERATE-1
Start date: June 2011
Phase: Phase 2
Study type: Interventional

This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET

NCT ID: NCT01373502 Completed - Stable Angina Clinical Trials

International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions

NEXT
Start date: October 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.

NCT ID: NCT01373164 Completed - Pancreatic Cancer Clinical Trials

A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer

Start date: June 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.

NCT ID: NCT01373151 Completed - Clinical trials for Rheumatoid Arthritis

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

Start date: June 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

NCT ID: NCT01372709 Completed - Clinical trials for Abdominal Aortic Aneurysm

TriVascular Post-Market Registry

Start date: May 2011
Phase:
Study type: Observational

This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.

NCT ID: NCT01372007 Completed - Rectal Carcinoma Clinical Trials

Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma

Start date: July 2011
Phase: Phase 3
Study type: Interventional

Total mesorectal excision (TME) is a precise dissection of the rectum and all para-rectal lymph nodes within the mesorectal envelope. It is becoming universally recognized and accepted as the standard technique for surgical excision of rectum carcinomas. TME results in lowest rates of local recurrence, especially when combined with pre-operative chemo-radiotherapy. Especially after pre-operative chemo-radiotherapy, the post-operative drainage may be important. The quick decrease of this drainage will enable the early mobilisation of the patient and may shorten the time of hospitalization. If this decrease in fluid production can be achieved, it will have a positive effect on the Quality of Life of the patient and will ensure health economic savings by reduction of hospitalization time and resources. Somatostatin analogues have shown to be able to decrease the secretion of numerous types of bodily fluids. The aim of this study is to investigate if lanreotide Autogel 120mg is capable to reduce the fluid discharge in patients that underwent a TME for rectumcarcinoma. Lanreotide Autogel 120mg compared to placebo, administered post-surgery on the fluid discharge in the drain of the patient that underwent a total mesorectum excision (TME) for rectal carcinoma. Patient planned to have a TME will be asked to participate in the study. When they have provided written informed consent, they will be randomized 1:1 to receive either placebo or lanreotide autogel 120mg. Drain fluid will be checked for hematocrit daily post-surgery. Once hematocrit levels of the drain fluid are <10%, study medication or placebo will be administered. After administration the volume of the drain fluid will be measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24 hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride analysis afterwards. If the patient has a hematocrit >10% in his drain fluid for a period of 5 days, this patient can not be randomized.

NCT ID: NCT01371682 Completed - Parkinson Disease Clinical Trials

A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda

Start date: September 18, 2009
Phase: Phase 1
Study type: Interventional

This is an open-label, randomised, two-period crossover, single dose study to demonstrate bioequivalence between the extended release 2 mg ropinirole XL tablets manufactured at two different sites in healthy subjects. Dosing will be under fasting conditions and there will be a minimum one week washout between doses. Domperidone will be administered to control dopaminergic side effects. Pharmacokinetic samples will be taken following each dose. Safety assessments will include screening and follow-up vital signs, ECGs and safety laboratory tests. Vital signs and adverse events will be monitored periodically throughout the study.