There are about 2320 clinical studies being (or have been) conducted in Chile. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.
Study Design: A double-blind randomized controlled study. Background: Patients operated on for carpal tunnel release surgery may persist with pain after surgery, which could be modulated by psychosocial factors such as depression, catastrophic thinking and kinesiophobia. Objectives: To evaluate the efficacy of a preoperative session in pain neuroscience education combined with postoperative therapeutic exercise in the perception of pain, functionality and psychosocial variables in patients following carpal tunnel release. Methods: Thirty participants were randomly assigned to the pain neuroscience education group combined with postoperative therapeutic exercise (n = 15) or to the control group with preoperative usual care combined with postoperative therapeutic exercise (n = 15). Evaluations included the Visual Analogue Scale (VAS), Disability of Arm, Shoulder, and Hand Questionnaire (QuickDASH), pain Catastrophizing Scale (PCS), Tampa scale of kinesiophobia (TSK-11) and Hospital Anxiety and Depression Scale (HADS) . A basal, fourth and twelfth week measurement was made.
This study is a pilot randomized controlled trial, comparing a group of older patients with standardized non-pharmacological delirium prevention plus a basic tablet versus a group with standardized non-pharmacological delirium prevention plus a tablet with a software of cognitive stimulation (PREVEDEL). Software:It is a local development, including a interprofessional team of delirium healthcare experts, older patients and a team og engineers. The software was developed during the first year of this project and was inscribed for author rights. Inclusion criteria: Older patients > 65 y.o. Admitted to medicine room or intermediate care unit > 48 hrs, and informed consent to participate. Exclusion Criteria:Delirium positive, neuroleptic use, dementia, and non-spanish speakers. The study was approved by ethical committee of Hospital Clinico University of Chile Standardized Non-pharmacological intervention: Health workers were previously educated in delirium, and environmental issues were implemented. This intervention coverage in nine different domains: orientation, early mobilization, environmental noise and light, sensorial deficit, sleep, hydratation, drug reduction, and family participation. Intervention: All patients will have a tablet with or without the software PREVEDEL between 09:00-19:00 hrs. Measures: delirium will be monitoring with CAM (Confusion Assessment Method) twice a day for 5 days. Primary outcome: Delirium rate between both groups Secondary outcomes:Long of stay, severity od delirium, time of use of electronic device, and Barthel to discharge.
The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.
This study evaluates whether the use of warmed solutions during cerebral angiography reduces the incidence of post-anaesthetic shivering. Half of participants will receive pre-warmed (39ºC) isotonic saline, while the other half receives the same solution at room temperature.
Primary Objective: - To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate the efficacy of dupilumab in children of 6 to <12 years of age with uncontrolled persistent asthma in the Japan sub-study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers. - To evaluate the safety and tolerability of dupilumab in pediatric patients with asthma in the Japan sub-study - To evaluate dupilumab in pediatric patients with asthma in the Japan substudy with regard to: - Systemic exposure, - Anti-drug antibodies (ADAs), - Biomarkers
- Introduction: The Cocaine Base Paste (or Coca Paste or CBP), a highly toxic and addictive smokable drug (a by-product of the cocaine extraction chain), has become in the last years a real social scourge for Chile. Today, there is not a pharmacological treatment approved in Chile neither around the world for the management of the withdrawal syndrome nor the dependence caused by the use of this substance. The N-Acetylcysteine (NAC), a derivative of the amino acid cysteine, with mucolytic and antioxidant properties, used in Chile since several years for bronchopulmonary treatments, as well as a hepatic and renal protector, among others, has shown, in animal and human research, that has benefits to reduce the craving for cocaine and in the management of the withdrawal syndrome of this and other psychoactive substances. - Objectives: To evaluate whether the use of NAC in patients with problematic CBP consumption reduce the craving for this substance and prolong its abstinence time. - Methods: will be carried out a randomized, double-blind, controlled, phase II-b clinical trial, with a parallel group design with CBP dependent patients in different outpatient care units in the province of Concepción, Chile. Patients who meet the cocaine (CBP) consumption disorder criteria, who have used of CBP within the last month and who have started to use it one year at least prior to admission to the study, will be selected from among the consulting population. Patients who agree to participate in the study must sign an informed consent form before being clinically evaluated. During the evaluations, semi-structured interviews and standardized questionnaires were used to investigate both consumption habits and symptoms of withdrawal and intensity of CBP craving, among others. All patients in the study will be attended twice weekly to treatment centers for four weeks, reporting their craving for CBP, the use of this substance (as well as urine tests), adverse reactions to the indicated medication, among others. - Expected results: It is expected that, thanks to the use of NAC, patients with CBP use disorder entered to this study significantly reduce their craving to consume this substance, they can prolong the abstinence time of it and they can reduce their falls in CBP consumption.
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo. Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.
This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.