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NCT ID: NCT01794793 Completed - Prostate Cancer Clinical Trials

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

Start date: June 10, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

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: NCT01794520 Completed - Clinical trials for Relapsed/Refractory Multiple Myeloma

Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma

Start date: October 10, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study also assessed the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma. The Phase 2 primary objective was to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.

NCT ID: NCT01794299 Completed - Clinical trials for Acute Myeloid Leukemia

Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells (ATIR) in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor

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

The purpose of this study is to determine whether ATIR is safe and effective in reducing transplant-related mortality and improving overall survival, when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor.

NCT ID: NCT01793883 Completed - Influenza Clinical Trials

Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza

Igloo
Start date: May 2013
Phase: Phase 2
Study type: Interventional

This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.

NCT ID: NCT01793077 Completed - Prostate Cancer Clinical Trials

Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients

TREMODI
Start date: December 2011
Phase: N/A
Study type: Observational

Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients. Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study. There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient. Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.

NCT ID: NCT01792440 Completed - Healthy Clinical Trials

The Sputum Colour Chart as a Predictor of Lung Inflammation and Proteolysis in Non-cystic Fibrosis Bronchiectasis

Start date: September 2009
Phase: N/A
Study type: Observational

Non-cystic fibrosis bronchiectasis patients (and controls) were recruited for the study. The investigators' aim was to study the relevance of clinical parameters in terms of underlying disease severity, proteolysis and inflammation in a diverse non-cystic fibrosis bronchiectasis population.

NCT ID: NCT01792427 Completed - Clinical trials for Non-cystic Fibrosis Bronchiectasis

Mortality in Non-cystic Fibrosis Bronchiectasis

Start date: June 2006
Phase: N/A
Study type: Observational

In this study we analyzed the overall survival for all newly diagnosed patients with non-cystic fibrosis bronchiectasis from June 2006 onwards. The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa and evaluate the impact on survival of etiology, number of different bacteriological species in retrospective and prospective sputa, azithromycin use and presence/development of pulmonary hypertension.

NCT ID: NCT01791361 Completed - Clinical trials for Metastatic Colorectal Cancer

Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe

Start date: September 19, 2012
Phase:
Study type: Observational

This non-interventional retrospective medical record review study will assess the prevalence of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation testing, this study will also assess data from the laboratory that performed the KRAS test. The study will also monitor changes in the pattern of Vectibix treatment between the different rounds of the study.

NCT ID: NCT01791231 Completed - Healthy Clinical Trials

A Study to Investigate the Absorption, Metabolism, and Excretion of Canagliflozin (JNJ-28431754) in Healthy Male Volunteers

Start date: August 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the absorption (the way the drug enters the body), metabolism (the way the drug is broken down in the body), and excretion (the way drug leaves the body) of canagliflozin (JNJ-28431754) in healthy male volunteers after a single dose of radiolabeled 14C-canagliflozin (14C-JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed.