Clinical Trials Logo

Filter by:
NCT ID: NCT02344277 Completed - Brugada Syndrome Clinical Trials

Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

S-ICD Brugada
Start date: May 12, 2015
Phase:
Study type: Observational

Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and sudden death resulting from episodes of polymorphic ventricular tachychardia and fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only treatment available is the implantation of an ICD. There is no discussion on the interest of the ICD implantation in secondary prevention and in patients who experienced syncope but the best therapeutic is more difficult to draw in asymptomatic patients. Recently we demonstrated that in asymptomatic patients with a spontaneous type 1 aspect of Brugada syndrome, (i) there was a significant risk of ventricular arrhythmia, (ii) the problem of inappropriate shocks can be solve with a good ICD programming and (iii) the problem of lead failure remains the main problem in this young population very active and represent the main limitation to larger indication of ICD implantation in this population with a very long life expectancy as these patients had a normal life expectancy except the risk of ventricular arrhythmia. In this context the S-ICD System (Boston Scientific Inc.) which is an implantable defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse generator and electrode system rather than a transvenous lead system, represents a very attractive opportunity as it gives the possibility to protect the patients of the risk of ventricular arrhythmia with no risk of lead failure. However, as this is a new technology and as Brugada syndrome patients are a very specific population (very active patients, specific and changing over time ECG aspect that is at risk of T wave over sensing and high risk of SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in this specific context.

NCT ID: NCT02344173 Completed - Atrial Fibrillation Clinical Trials

ABLATOR Ablation Observational Registry

ABLATOR
Start date: November 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

NCT ID: NCT02343874 Completed - Alcohol Consumption Clinical Trials

Impact of Alcohol Consumption on Use of Health Care Resources

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

The prevalence of alcohol-related disorders in the general population is around 10%. The relationship between the use of healthcare services, costs and the amount of alcohol consumed by the general population is unknown. Because alcoholism is a major public health problem, it is significant to determine the prevalence of consumption of primary users and the relationship between the dose of alcohol and health care costs. This information may allow the implementation of preventive strategies to reduce consumption with the aim to reduce morbidity and healthcare expenditure. A cross-sectional study will be carried out. Patients over 17 years old, treated at primary healthcare centers in Catalonia that have available data on alcohol consumption from January 2010 to December 2012 will be included. Clinical and sociodemographic data will be collected. Health service use and health care costs from 2013 will be collected from SIDIAP (The Information System for the Development of Research in Primary Care) database. A positive relationship between grams of alcohol consumed per week and the use of resources and health expenditure will be expected and also the level of risk of alcohol consumption. There will be a descriptive analysis of the clinical data and sociodemographic variables. A multivariate analysis will be done to see the relationship between alcohol consumption and health care costs and health care service utilization.

NCT ID: NCT02343406 Completed - Glioblastoma Clinical Trials

Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas

INTELLANCE-2
Start date: February 17, 2015
Phase: Phase 2
Study type: Interventional

This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.

NCT ID: NCT02343185 Completed - Low Back Pain Clinical Trials

Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

Start date: January 2014
Phase: N/A
Study type: Interventional

This study is a double-blind randomized clinical trial with two arms which aims to study the effects of diaphragmatic treatment in patients with nonspecific low back pain. Low back pain has a great importance in today's society, and it is therefore important to develop an effective treatment for this condition. People with chronic nonspecific low back pain, can present respiratory disorders and get anxiety states, affecting mainly the diaphragm muscle. Therefore, given its direct anatomic relationship, the diaphragm may be part of the development of chronic low back pain. Although clinical practice guidelines for chronic low back pain have been developed, it hasn't been explored before a physiotherapy treatment especially aimed at a diaphragmatic treatment. A double-blind randomized clinical trial with two arms will be used for this purpose, 64 patients with nonspecific low back pain referred from different hospitals of Castellón will be randomized into two groups: - Diaphragmatic intervention with osteopathic manual therapy treatment (D). - Diaphragmatic intervention with placebo treatment group (P). An osteopathic manual therapy protocol for the treatment of back pain including techniques for the diaphragm muscle will be applied to the patients in group D, in a total of 5 sessions. For patients in group P, the same protocol will be performed on the diaphragm but with placebo treatment techniques. The study focuses on the analysis of the following variables: scores on the questionnaires: - Pain: McGill Pain Questionnaire and VAS (Visual Analogical Scale ). - Fear Avoidance: (FABQ) - Disability: Oswestry Disability Index and Roland-Morris - Anxiety: HADS: (Hospital Anxiety and Depression Scale) - Catastropizing: PCS (Pain Catastropizing Scale) - Satisfaction with treatment (Escala de Satisfacción con el tratamiento) The results of these pre-intervention and post-intervention variables will be compared between the two groups in the first session, in the fourth session and in the first and third month after the first intervention. The VAS score will also be assessed in the second and third session.

NCT ID: NCT02343172 Completed - Liposarcoma Clinical Trials

Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma

Start date: March 13, 2015
Phase: Phase 1
Study type: Interventional

To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.

NCT ID: NCT02342847 Completed - Clinical trials for Pancreatic Neoplasms

Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer

aLIVE
Start date: December 10, 2014
Phase:
Study type: Observational

This is an observational, post-authorization, prospective follow-up, multi-centre, national study designed to describe the spectrum of health-related quality of life in patients with metastatic pancreatic cancer previously untreated with chemotherapy This study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. Patients will be enrolled in 7 Spanish sites. In all cases, the decision to treat patients will be performed prior to the decision to include the patient in the study. Given the observational nature of the study, follow-up of patients will be performed according to standard clinical practice of each site.

NCT ID: NCT02342522 Completed - STEMI Clinical Trials

Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.

NCT ID: NCT02341768 Completed - Arrythmia Clinical Trials

Clinical and Device Functional Assessment of Real World ICD Patients

CARAT
Start date: June 2015
Phase:
Study type: Observational

The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms of techniques and medical devices, based on the patient's condition. It is extremely important in the clinical practice to identify which patients' subgroup benefits the most from the ICD therapy, which comorbidity has a major impact on the patients' prognosis, or which pre-intra-post procedural behaviors provoke less complications, and affect the patient's outcome (including prolonged or unwanted hospitalizations).

NCT ID: NCT02341534 Completed - Clinical trials for Myocardial Infarction

BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction

BIO-GUARD-MI
Start date: August 7, 2015
Phase: N/A
Study type: Interventional

The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.