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NCT ID: NCT01736735 Recruiting - Heart Failure Clinical Trials

Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects

STEPWISE
Start date: January 2013
Phase: Phase 2
Study type: Interventional

This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.

NCT ID: NCT01729663 Recruiting - Cutaneous Melanoma Clinical Trials

Phase II/III Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in Stage IIB, IIC and III Melanoma Patients

Start date: April 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine , allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon alfa 2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous melanoma patients. This study has been approved by ANMAT ( Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar). The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma de Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.). Study population include a total of 108 patients (72 patients will receive CSF470 vaccine and 36 patients will receive alpha IFN-alpha 2b) for a total of 24 months. CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then one dose every two months for the first year and them every three months for the second year. Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines, not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used. IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for four weeks and then 5 MU (3t/w) for 23 months. Both treatments will also compare quality of life (QOL) and study a possible correlation in the CSF470 vaccine arm between the induced immune response and clinical outcome

NCT ID: NCT01719055 Recruiting - Pain Clinical Trials

RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

RELIEF
Start date: November 19, 2012
Phase:
Study type: Observational

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use - and - To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

NCT ID: NCT01705873 Recruiting - HIV Clinical Trials

Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen

Start date: September 2012
Phase: N/A
Study type: Observational

The objective of this study is to evaluate changes in Framingham score (from low to moderate, from moderate to high) based on changes in lipid profile and other parameters from baseline to 48 weeks of HAART in naïve patients or patients in second line of treatment, considering LPV/r vs EFV based HAART. The null hyphotesis is that there is an increased Framingham score in patients treated with LPV/r as second line treatment and in patients treated with LPV/r or EFV regimen as first line treatments.

NCT ID: NCT01610037 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation

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

The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.

NCT ID: NCT01574053 Recruiting - Clinical trials for Huntington's Disease

Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

Start date: July 2012
Phase:
Study type: Observational [Patient Registry]

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

NCT ID: NCT01524276 Recruiting - Clinical trials for Coronary Artery Disease

Product Surveillance Registry

PSR
Start date: January 2012
Phase:
Study type: Observational

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

NCT ID: NCT01502098 Recruiting - Rotator Cuff Tear Clinical Trials

Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

Start date: January 2012
Phase: N/A
Study type: Interventional

The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.

NCT ID: NCT01432548 Recruiting - Ischemic Lesions Clinical Trials

Ischemic Preconditioning. Prospective Comparison

IP
Start date: July 2011
Phase: N/A
Study type: Interventional

Vascular occlusion is used to reduce blood loss during liver resection (LR), but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. This restriction of blood flow (ischemia) and subsequent restoration (reperfusion) causes a harm that is called ischemia- reperfusion injury. Injuries sustained during the ischemic phase are related to a lack of oxygen to reduce cellular respiratory events can lead to, in a few minutes, irreversible damage. Ischemic preconditioning as a technique to protect the liver parenchyma during liver resection consists of an initial flow clamping for 10 minutes, with subsequent reperfusion for 10-15min, followed by a complete portal triad clamping during transection.

NCT ID: NCT01372514 Recruiting - Pulmonary Embolism Clinical Trials

Institutional Registry of Thromboembolic Disease

IRTD
Start date: August 2006
Phase:
Study type: Observational

The purpose of this study is to create an institutional registry of Thromboembolic disease through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival. The main goal is to describe the occurrence of thromboembolic disease and the characteristics of clinical presentation, evolution and predisposing factors of these episodes in the population of the Hospital Italiano de Buenos Aires.