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NCT ID: NCT01515423 Completed - Schizophrenia Clinical Trials

Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

NCT ID: NCT01515189 Completed - Melanoma Clinical Trials

Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

Start date: February 17, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg

NCT ID: NCT01515007 Completed - Clinical trials for Non Cystic Fibrosis Bronchiectasis

Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)

Start date: March 31, 2014
Phase: Phase 3
Study type: Interventional

This study (ARD-3150-1201, ORBIT-3) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.

NCT ID: NCT01514188 Completed - Clinical trials for Metastatic Soft Tissue Sarcoma

Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma

Start date: January 11, 2012
Phase: Phase 2
Study type: Interventional

This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.

NCT ID: NCT01513018 Completed - Clinical trials for Postoperative Lung Injury

Effects of High and Low Tidal Volumes on Arterial Oxygenation and Pulmonary Shunt During One-Lung Ventilation

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

The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery. The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during OLV. One hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute. During the subsequent 30 minutes, each patient received the alternative management. Minute volume was thus kept constant during each experimental condition. Arterial blood partial pressures, hemodynamic responses, and ventilatory parameters were recorded. Results are presented as means ± SDs; P < 0.05 was considered statistically significant.

NCT ID: NCT01511367 Completed - Asthma Clinical Trials

Comparison of Flutiform, Fluticasone and Seretide in Treatment of Moderate to Severe Asthma in Paediatric Patients

Start date: March 2012
Phase: Phase 3
Study type: Interventional

This is a comparator study to assess safety and efficacy of Flutiform compared with Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe persistent, reversible asthma.

NCT ID: NCT01507831 Completed - Clinical trials for Hypercholesterolemia

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Start date: January 2012
Phase: Phase 3
Study type: Interventional

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: - To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. - To evaluate the effects of alirocumab on other lipid parameters.

NCT ID: NCT01506609 Completed - Clinical trials for Metastatic Breast Cancer

Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

Start date: January 23, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

NCT ID: NCT01500720 Completed - Clinical trials for Small Cell Lung Cancer

Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

Start date: March 2012
Phase: Phase 2
Study type: Interventional

Primary Objective: To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy. Secondary Objectives: - To assess disease progression free rate at 12 weeks - To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response - To assess Overall Survival (OS) - To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03) - To assess the Health-Related Quality of Life (HRQoL)

NCT ID: NCT01500616 Completed - Clinical trials for Hepatitis C, Chronic

Telaprevir Open-Label Study in Co-Infected Patients

Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect safety and tolerability data on telaprevir treatment in combination with Peg‑IFN‑alfa and RBV in patients with HIV/genotype 1 chronic HCV coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment into an ongoing clinical study of telaprevir.