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NCT ID: NCT01573416 Completed - Clinical trials for Substance-Related Disorders

"Effectiveness of a Brief Intervention for Substances Consumption Linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): A Randomized Control Trial in Chilean Primary Care."

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

Alcohol and drugs consumption are among the highest risk factor for health in Chile and abroad. In Chile, harmful use of alcohol continues to be a major contributor to the burden of disease while lost years of healthy life are higher than many other risk factors such as hypertension, overweight and obesity, and hyperglycemia. It is important to say that the impact of alcohol consumption is greater in younger age groups where fatal injuries occur relatively early in life, as well. In Chile, the consumption pattern in 2008 showed that 49.8 % consumed at least once in the last month for alcohol, 3.5 % for marihuana and 1.3 % for cocaine. This prevalence was even greater in young adults and adolescents and is associated with other mental health issues and poorer life quality. Those who have consumed marihuana during the last year, 25% report dependence symptoms. For cocaine derives, dependency rises up to 50% among the consumers. This data reinforce the need to design and implement strategies for reducing alcohol and drugs consumption in our population. Also, it is well known that a high number of those who suffers from any addiction problem do not get attention in a specialized center. The are many barriers to do so, such as lack of motivation, lack of resources, social problems, access to care problems, and so on. Chile has a shortage of preventive interventions for those at risk to develop an addiction at an early stage of substance use because front line health services (Primary health care and emergency care) and other social services (police stations, local justice courts) do not have a screening system and a model of brief intervention. The Pontificia Universidad Catolica de Chile, through its Addiction Studies Center (CEDA UC) and its Department of Family Medicine, is working in conjunction with SENDA (Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol ) to design, implement and evaluate a communal system for early detection, brief intervention and referral to treatment (SBIRT), in people older than 18 years, with substance consumption in five municipalities in the country. The aid of this study is to demonstrate that a model of brief intervention is more effective than the approach currently used in patients with substance use at moderate risk (i.e.follow-up). It is a multicentric randomized controlled trial, single blind, with a group to receive brief intervention and a control group that is kept in control and waiting list being re-evaluated three months later. The target population is composed by users whose ASSIST screening scores place them in the moderate risk group, for which there has not been defined a structured intervention yet by our health system. The information will be obtained from the scores obtained after the application of the ASSIST-WHO questionnaire.

NCT ID: NCT01571284 Completed - Clinical trials for Colorectal Cancer Metastatic

Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

Start date: May 30, 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants Secondary Objective: To document the Health-Related Quality of Life of aflibercept in this participants population

NCT ID: NCT01566721 Completed - Breast Neoplasms Clinical Trials

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

SafeHER
Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

NCT ID: NCT01565070 Withdrawn - Knee Osteoarthritis Clinical Trials

Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

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

Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.

NCT ID: NCT01560637 Completed - Clinical trials for Pulmonary Arterial Hypertension

An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

Start date: September 11, 2013
Phase: Phase 3
Study type: Interventional

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

NCT ID: NCT01560624 Completed - Clinical trials for Pulmonary Arterial Hypertension

Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy

FREEDOM-EV
Start date: June 26, 2012
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.

NCT ID: NCT01555996 Completed - Delirium Clinical Trials

Early Occupational Therapy for Delirium Prevention in Older Patients Admitted to Critical Care Unit

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

This is a randomized, controlled trial to compare the efficacy of two strategies of non-pharmacological prevention of delirium in critically non-ventilated older patients: - standard non-pharmacological prevention - intensive nonpharmacological prevention (standard non-pharmacological prevention plus early and intensive occupational therapy).

NCT ID: NCT01553526 Active, not recruiting - Clinical trials for Coronary Artery Disease

BIOFLOW-III All-comers Orsiro Safety and Performance Registry

BIOFLOW-III
Start date: August 2011
Phase: N/A
Study type: Observational

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

NCT ID: NCT01550003 Completed - Clinical trials for Polyarticular-course Juvenile Idiopathic Arthritis (JIA)

Pediatric Arthritis Study of Certolizumab Pegol

PASCAL
Start date: March 8, 2012
Phase: Phase 3
Study type: Interventional

A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).

NCT ID: NCT01545492 Recruiting - Obesity Clinical Trials

Testing the Developmental Origins Hypothesis

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

INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk. CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference. OBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.