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NCT ID: NCT01960634 Completed - Clinical trials for Stage IV Skin Melanoma

Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma

BRAFV600
Start date: April 2013
Phase: N/A
Study type: Observational

This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples. Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice. The treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.

NCT ID: NCT01960543 Completed - Clinical trials for Complication of Anesthesia

Effects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients

Start date: October 2013
Phase: Phase 4
Study type: Interventional

Elderly patients with hip fracture are frail due to associated comorbidity. In these situations, regional anesthesia is recommended as it is associated to less postoperative cognitive dysfunction. However, hypotension during the process may impair ischemic cardiopathy and induce a cerebrovascular stroke. Selection of the right anesthetic agent and the administration of vasoactive drugs during the process can minimize these risks. Although bupivacaine and levobupivacaine share pharmacokinetic and pharmacodynamic properties, the studies show conflicting results. The aim of this study is to investigate if there are clinically relevant differences between these two drugs in terms of hemodynamic parameters during the surgical process with special focus on the effects on regional cerebral oximetry and cognitive status after surgery.

NCT ID: NCT01960348 Completed - Clinical trials for Amyloidosis, Hereditary

APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis

Start date: November 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.

NCT ID: NCT01959659 Completed - Schizophrenia Clinical Trials

A Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia to Describe Medical Resource Utilization and Burden of Illness

Start date: May 2013
Phase: N/A
Study type: Observational

This non-interventional, cross-sectional survey and retrospective review will evaluate the medical resource utilization and burden of illness in patients who have persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the 3 months prior to enrolment. Medical records will be reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at a single visit will include rating scales and questionnaires that reflect the clinical status and the quality of life of the patients and the economic impact of schizophrenia.

NCT ID: NCT01959555 Completed - Clinical trials for Congenital Bleeding Disorder

Project to Update the Study of Congenital Haemophilia in Spain

PUCHS
Start date: March 2014
Phase: N/A
Study type: Observational

This study is conducted in Europe. The aim of the study is to update the knowledge about the prevalence and severity of congenital haemophilia (A and B) in Spain.

NCT ID: NCT01959529 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

DEVOTE
Start date: October 29, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

NCT ID: NCT01959516 Completed - COPD Clinical Trials

Effect of Glycopyrronium on Morning Symptoms and Pulmonary Function in Patients With Moderate to Severe COPD

Start date: February 2014
Phase: Phase 4
Study type: Interventional

This study purpose is to further study the profiles of glycopyrronium (NVA237) and tiotropium during the first hours after dosing and their impact on pulmonary function, COPD symptoms and ability to perform daily activities by the patient.

NCT ID: NCT01958021 Completed - Clinical trials for Advanced, Metastatic Breast Cancer

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)

MONALEESA-2
Start date: December 17, 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo controlled trial.

NCT ID: NCT01957878 Completed - Clinical trials for HUMAN PAPILLOMA VIRUS

Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL

RHEIA-VAC
Start date: December 2013
Phase: Phase 2
Study type: Interventional

Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential. This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream). ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant. The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.

NCT ID: NCT01957150 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

Start date: January 28, 2014
Phase: Phase 4
Study type: Interventional

This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.