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NCT ID: NCT01590342 Terminated - Pulmonary Embolism Clinical Trials

Diclofenac for Submassive PE

AINEP-1
Start date: May 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to demonstrate the clinical benefits of diclofenac (added to standard anticoagulant therapy) over placebo in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction. The secondary objective is to assess the safety after administration of diclofenac in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction.

NCT ID: NCT01584297 Terminated - Clinical trials for Granulosa Cell Tumour of the Ovary

Ketoconazole as Inhibitor of the Enzyme CYP17 in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary

GreKo
Start date: October 2012
Phase: Phase 2
Study type: Interventional

Our proposal is to conduct an open phase II clinical trial that allows us to explore the activity of ketoconazole, an inhibitor of the enzyme CYP17, in ovarian granulosa tumors similar to what has been done in prostate cancer. The rational is based on dysregulation that FOXL2 mutations present in almost all granulosa tumors result in the expression of CYP17 that appears to be key in the development and progression of the disease. This work would represent the first attempt to address the treatment of ovarian granulosa cancer with a molecular solid rational, drawing on the recent identification of the mutation "leader" of this tumor. If succeed provide a widely available therapeutic alternative compared with current cancer therapies, with low toxicity. In addition it would open a new line of research with CYP17 enzyme inhibitors that could alter the course and outcome, usually fatal, in advanced stages of disease.

NCT ID: NCT01583114 Terminated - Clinical trials for Dilated Cardiomyopathy

PREclinical Mutation CARriers From Families With DIlated Cardiomyopathy and ACE Inhibitors

PRECARDIA
Start date: December 2011
Phase: Phase 3
Study type: Interventional

This is a multicentre European double-blind,randomized and controlled trial with 2 parallel groups (1 study medication, 1 placebo) in order to analyse the impact of ACE inhibitors (ACEi) in subjects who carry a mutation but have not yet developed DCM (dilated cardiomyopathy). Objective of the trial: Study the impact of ACE inhibitors (ACEi) in subjects who carry a mutation (leading to a genetic form of heart failure) but have not yet developed DCM. Context. Dilated Cardiomyopathy (DCM) is one of the leading causes of Heart Failure due to systolic dysfunction and at least 30% of DCM are of familial/genetic origin, usually with autosomal dominant inheritance, and underlying genes and mutations are increasingly identified. Familial Dilated Cardiomyopathy (fDCM) is characterized by age-related penetrance (or delayed-onset), that means that the cardiac expression of the disease (echocardiographic abnormalities) is usually absent for a long period and progressively appears with advanced age, usually after 20 years of age Hypothesis : ACEi may delay or prevent the occurrence of DCM in these subjects (pre-clinical stage). Expected results: If the hypothesis is confirmed, and as a consequence, the knowledge derived from basic research (genes identification in DCM) will be translated into clinical practice (early identification of subjects at high risk of developing heart failure through predictive genetic testing) with the development of new therapeutic management (early ACEi) that will help to decrease the morbidity and mortality associated with the disease. This will constitute a paradigm of the development of preventive medicine thanks to the development of genetics in the cardiovascular field. Subjects who are concerned are ≥18 years of age and ≤60 years, carry a mutation responsible for DCM and are at a preclinical stage of the disease. Total duration of treatment (perindopril versus placebo) is 3 years. A total number of 200 participants will be enrolled (100 in each group) in 7 centres.

NCT ID: NCT01582672 Terminated - Clinical trials for Renal Cell Carcinoma

Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

ADAPT
Start date: November 2012
Phase: Phase 3
Study type: Interventional

This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

NCT ID: NCT01579578 Terminated - Clinical trials for Metastatic, Gastric or Gastro-oesophageal Junction, Cancer

Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer

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

The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.

NCT ID: NCT01576432 Terminated - Pain Clinical Trials

Non-pharmacological Analgesia During Heel Prick

Start date: January 2011
Phase: N/A
Study type: Interventional

Objective To investigate the analgesic effect (measured with NIPS) of breastfeeding in addition to skin-to-skin contact versus other methods of non-pharmacological analgesia during blood sampling through heel lance in healthy term neonates. The influences of non-pharmacological methods on crying time, percentage of crying while sampling, heart rate, number of attempts and duration of sampling were studied. Methods Randomised controlled trial performed on 136 healthy term newborns in the maternity ward of a tertiary hospital. The inclusion criteria were: healthy term neonates, wish to breastfeed and absence of feeding during the previous 60 minutes. Neonates were randomly assigned to four groups: group 1, breastfed with skin-to-skin contact ; group 2, oral sucrose with skin-to-skin contact ; group 3, skin-to-skin contact ; or group 4, receiving oral sucrose Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.

NCT ID: NCT01570530 Terminated - Atrial Fibrillation Clinical Trials

Atorvastatin Using as a Possible Prophylaxis of Postoperative Atrial Fibrillation After Cardiac Surgery

PROFACE
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs.

NCT ID: NCT01570361 Terminated - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Progression Trial

ATTEST
Start date: February 13, 2012
Phase: Phase 4
Study type: Interventional

The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.

NCT ID: NCT01570192 Terminated - Bacterial Pneumonia Clinical Trials

Clinical Trials to Reduce the Risk of Antimicrobial Resistance

Start date: September 2010
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged infusion in combination with a parenteral aminoglycoside plus tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 - control arm).

NCT ID: NCT01568216 Terminated - Schizophrenia Clinical Trials

20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms

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

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.