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NCT ID: NCT01335477 Completed - Pulmonary Fibrosis Clinical Trials

Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II

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

Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo. Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data. Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

NCT ID: NCT01335399 Completed - Multiple Myeloma Clinical Trials

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

ELOQUENT - 1
Start date: August 4, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

NCT ID: NCT01335087 Completed - Clinical trials for Obstructive Sleep Apnea

Continuous Positive Airway Pressure (CPAP) in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea (OSA)

ISAACC
Start date: April 2011
Phase: N/A
Study type: Interventional

OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA admitted in a hospital for an acute coronary syndrome. Overall objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical evolution of patients with acute coronary syndrome (ACS). Primary objectives: 1. To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with ACS and co-occurring sleep apnea. Secondary objectives: 1. Determine the prevalence of OSA in patients who have suffered an episode of ACS. 2. Other secondary objectives will include the effects of CPAP on: - To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic stroke. - Components of primary composite endpoints - Re-vascularization procedures - To evaluate all-cause death - To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias - To evaluate newly diagnosed diabetes mellitus, according to standard definitions - To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS)) - To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D). 3. To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS. 4. To establish the relationship between CPAP compliance and CV events incidence. 5. To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients. 6. To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.

NCT ID: NCT01335035 Completed - Iron Overload Clinical Trials

Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload

Start date: December 2008
Phase: Phase 4
Study type: Interventional

This study has been designed to establish the efficacy and safety of deferasirox in patients with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant (HSCT). The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of treatment with deferasirox, in patients with iron overload (defined with serum ferritin levels ≥ 1000 ng/ml and receiving > 20 RBC concentrates) after allogeneic HSCT.

NCT ID: NCT01334840 Completed - Clinical trials for Cardiovascular Diseases

Mechanism of Action of Vichy Catalan Water

Start date: November 2009
Phase: N/A
Study type: Interventional

Water consumption is essential to maintain hydration and good health. Sodium-bicarbonated mineral waters are reported to have beneficial digestive and hypocholesterolemic properties. The aim of this study was to investigate the effects of the consumption of a sodium-bicarbonated mineral water (BW) with or without a meal, compared to a low mineral content water as a control water (CW), on postprandial serum triacylglycerols (TAG), cholecystokinin (CCK), and gallbladder volume.

NCT ID: NCT01333228 Completed - Liver Cirrhosis Clinical Trials

Evaluate Safety and Efficacy of Autologous Bone Marrow-derived Endothelial Progenitor Cells in Advanced Liver Cirrhosis

Start date: June 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Endothelial Progenitor Cells (EPC) represent a small cellular population of bone marrow and peripheral blood cells. EPCs are recruited into injured tissues and play an important role in regeneration and reparation. Experimental and clinical data suggest that EPCs have hepatoprotective activity and could improve liver regeneration during acute and chronic liver injury. The aim of this project is to evaluate the safety and therapeutic effects of autologous bone marrow-derived EPCs, when administered through the hepatic artery of patients with advanced liver cirrhosis.

NCT ID: NCT01332968 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)

Start date: July 6, 2011
Phase: Phase 3
Study type: Interventional

This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response [CR] or partial response [PR]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.

NCT ID: NCT01332656 Completed - Clinical trials for Ovarian Cancer Recurrent

Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

OPSALIN
Start date: May 2011
Phase: Phase 2
Study type: Interventional

Primary Objective: - To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin. Secondary Objectives: - To compare the overall survival (OS) between the 2 treatment arms - To compare the objective response rate (RR) between the 2 treatment arms

NCT ID: NCT01332604 Completed - Solid Cancers Clinical Trials

GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.

NCT ID: NCT01332227 Completed - Clinical trials for HIV, Combination Therapy

Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1—Infected Patients

SPARTAN
Start date: October 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether HIV-1—infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.