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NCT ID: NCT01645059 Completed - Clinical trials for Disseminated HER2+ Breast Cancer

Multicenter Descriptive Study of the Patient Clinical Profile That Begins With Disseminated Her 2 + Breast Cancer or Develops a Metastasis After or During the Adjuvant Therapy

PRIMHER
Start date: July 2011
Phase: N/A
Study type: Observational

This is an observational, cross-sectional study that the main objective is to describe the patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a metastasis after or during the adjuvant treatment.

NCT ID: NCT01644643 Completed - Clinical trials for Complicated Urinary Tract Infection

Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

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

To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

NCT ID: NCT01643980 Completed - Clinical trials for Early Onset of Delivery Before 37 Weeks

Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies

PESAPRO
Start date: August 2012
Phase: Phase 4
Study type: Interventional

The preterm birth is considered as a main problem in the modern obstetrics, being the responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the significant medical advances, the rate of prematurity has not declined over the past 40 years and even continues to rise in the developed countries. In order to decrease the prematurity is necessary that two premises: to identify the pregnant women at risk of preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm delivery. The investigators propose a clinical trial with the objective to identify effective strategies to reduce the premature birth (34 weeks and earlier) rate in the population of pregnant women at risk for premature birth, which will be identified by ultrasound during the second trimester of their pregnancy. The investigators intend to compare two accepted strategies: administration of progesterone (vaginally) or the placement of vaginal pessaries. These 2 strategies are affordable, easy to apply, and they present very few maternal-fetal secondary effects.

NCT ID: NCT01643915 Completed - Clinical trials for Disruptive Global Behavior During Previous Treatment Visits

Behavior Management Using Audiovisual Tools

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

The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric patients during dental treatment improves when a cartoon film is viewed or a videogame is played as methods of distraction.

NCT ID: NCT01642472 Completed - Uterine Fibroids Clinical Trials

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

PEARLext2
Start date: July 2012
Phase: Phase 3
Study type: Interventional

This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024). This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.

NCT ID: NCT01642394 Completed - Diabetes Mellitus Clinical Trials

Impact of Self-care Education Program in Patients With Type 2 Diabetes in Primary Care in the Basque Country

Start date: October 1, 2011
Phase: N/A
Study type: Interventional

Main objective:To evaluate the effectiveness of the "Diabetes Self-Management Programme" (DSMP) on the metabolic control, cardiovascular risk reduction, quality of life and self-efficacy in adult patients with type 2 diabetes, compared with current standard care of patients with type 2 diabetes, in the context of Osakidetza's Primary Care network. Secondary objectives: - To evaluate the impact of the implementation of DSMP in the use of health services. - To assess the impact of DSMP in the cost of treatment of the involved population. - To evaluate the improvement in physical activity and diet patterns among the participants. - To describe the feasibility of implementing the DSMP in the Basque Country's primary health care system Methodology: Randomized clinical trial in which patients diagnosed with type 2 diabetes aged between 18 and 80 years pertaining to 4 primary regions of the Basque country, who agree to participate in the study, will be randomly assigned to two groups: the intervention group (the DSMP programme) and the control group. The intervention will be performed by trained patients with type 2 diabetes and health professionals and it will consist in 6 group sessions of two and a half hours each, on a weekly basis with a overall duration of 6 weeks. The session content includes techniques for dealing with problems, promotion of exercise, nutrition concepts, proper use of medication, effective communication and basic knowledge about diabetes and its complications. The sessions are supported with educational material. The main outcome is the improvement of HbA1c (glycated hemoglobin) levels. Secondary outcomes are reduction of cardiovascular risk, increase of quality of life and self-efficacy. The results will be analyzed at 6, 12 and 24 months after the intervention. Hypothesis: An educational intervention on patients with type 2 diabetes mellitus based on the program DSMP conducted by previously trained lay persons and health professionals, improve metabolic control as measured on a 0.5% decrease in Hb A1c (Clar, 2010),compared to regular health education. On the other hand, it is expected to see improvements in the quality of life for these patients. The intervention may reduce the weight and cardiovascular risk due to changes in the physical activity and diet patterns, getting to a more appropriate use of health services and medication. It is expected that changes in the variables occur 6 months after the intervention and remain over the time

NCT ID: NCT01642134 Completed - Stroke Clinical Trials

Dual Antiplatelet Therapy Versus Oral Anticoagulation for a Short Time to Prevent Cerebral Embolism After TAVI

AUREA
Start date: April 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the incidence of major vascular events (ischemic or haemorrhagics) at the third month after initiation of the antithrombotic treatment (oral anticoagulation or dual antiplatelet therapy) in both arms followed TAVI.

NCT ID: NCT01642004 Completed - Clinical trials for Squamous Cell Non-small Cell Lung Cancer

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

Start date: October 16, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

NCT ID: NCT01641978 Completed - Clinical trials for To Evaluate Glasgow Coma Scale's Interobserver Reliability Among ICU's Nurses

INTEROBSERVER CORRELATION OF GLASGOW COMA SCORE

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

The assessment of the level of consciousness in patients admitted to intensive care units (ICU) can be complicated because the varaibles that are evaluated can be interpreted in a diferent way by different observers. The main objective is to determine interobserve agreement of the Glasgow Coma Scale (GCS) among ICU nurses and assess wheter prpfessional experience change the results. Secondary objective: to determine interobserver agreement in each of the three components (motor response, verbal and eye opening) of the GCS

NCT ID: NCT01641965 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Impact of Early Non Invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Patients

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

Timing of initiating domiciliary no invasive ventilation (NIV) in amyotrophic lateral sclerosis patients remains unclear. The hypothesis of the study is that the early use of NIV, in the initial phase of respiratory muscle weakness, improves the prognosis of ALS patients. Principal objective: To evaluate the impact of early NIV in the survival of ALS patients. Secondary objectives:To determine the effects from early NIV in the progression of respiratory muscle weakness. To analyze the impact of early NIV in the quality of life of ALS patients. To evaluate the correlation between the FVC and other parameters of respiratory evaluation (maximal inspiratory pressure (MIP), sniff nasal inspiratory pressure (SNP), nocturnal desaturation) and their utility in the early indication of the NIV. To evaluate the tolerance to the early NIV. Methods: multicentric, randomized, open-label, controlled clinical trial with a parallel treatment design. Patients will be included when their FVC reaches the threshold of the 75% of the predicted value and will be randomized in: Group A: the NIV treatment will begin immediately and Group B: the NIV treatment will be started when patients fulfil at least one of the following criteria: (i) FVC < 50% predicted, (ii) orthopnea, and/or (iii) PaCO2 > 45 mmHg. Follow-up visits will be done every three months with pulmonary function test, nocturnal pulse oximetry, quality of life and quality of sleep tests, assessment of disease progression (ALSFSR-R scale), tolerance and compliance with NIV.