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.
In critically ill patients, sleep and circadian rhythms are markedly disturbed, including sleep deprivation and disruption, as well as altered sleep architecture, and loss of normal oscillations of Melatonin and Cortisol. These alterations have been associated with delirium, fatigue, and higher mortality. In addition, sleep disturbances may remain after hospital discharge, and they have been associated with psychological comorbidities, which may contribute to the low quality of life observed in ICU survivors. Patient factors for sleep deprivation in ICU are the type/severity of underlying illness, the pathophysiology of the acute illness, pain, and stress/anxiety. Factors associated with the ICU, such as exposure to inadequate levels of light and noise, or inflexible schedules of daily care activities, have also been reported to have a major role in sleep disturbance. A limited number of studies have evaluated interventions targeting sleep optimization in the ICU, using strategies like eye masks and/or earplugs to isolate patients from their environment, the application of a dynamic light system that ensures light at night and higher levels of light at daytime to restore circadian rhythm, or auditory masking, to avoid intense cortical stimuli secondary to annoying noises. These strategies have been reported to have some positive impacts on sleep in ICU but this has only been assessed by qualitative instruments. In addition, they have been tested as isolated interventions, and not as part of a more comprehensive approach. The goal of this project is to determine the impact of a multifaceted intervention of environmental control in the ICU, based on dynamic light therapy, auditory masking, and rationalization of ICU nocturnal patient care activities, on quantity and quality of sleep, assessed by polysomnography and other semi-quantitative methods, compared to standard care. In addition, the effect of both strategies on delirium, circadian rhythm biomarkers, and long-term neuropsychological outcomes will be compared. This is a prospective, parallel-group, randomized trial in 56 critically ill patients once they are starting to recover from their acute illness. After obtaining informed consent, patients will be randomized to receive a multifaceted intervention of environmental control or standard care. And this protocol will be applied from enrollment until ICU discharge, with a follow-up before hospital discharge and at 6 months.
Background: In postmenopausal women, an alteration in body composition occurs as a consequence of the secretion of low levels of serum estrogens by the ovaries. Observing an increase in abdominal and mammary fat mass and a decrease in skeletal muscle mass, which is also accompanied by loss of muscle strength and physical function, which leads early to a sarcopenia. On the other hand, the increase in estrogen production by adipose tissue has been associated with an increased risk of breast cancer during menopause because the mammary parenchyma is particularly sensitive to this type of estrogen. For this reason, Hormone Therapy (Aromatase Inhibitors and Tamoxifen) is prescribed in women with estrogen receptor-positive breast cancer. Antineoplastic treatments (Chemotherapy and Hormonal Therapy) have contributed to non-metastatic breast cancer currently presenting a high survival rate, not without adverse effects associated with the course of the disease, age and antineoplastic treatment, affecting various systems, but particularly skeletal muscle mass. Therefore, resistance exercise training has been proposed as an effective intervention strategy to increase muscle mass and strength in different populations. However, the level of muscle response to this type of training in postmenopausal women survivors of breast cancer with and without hormone treatment (Aromatase Inhibitors and Tamoxifen) is unknown.
Chronic nonspecific neck pain is a common musculoskeletal disorder recognized for its high rates of disability and economic losses, ranking second in musculoskeletal conditions after low back pain. There are several effective physical therapy interventions to treat chronic nonspecific neck pain, such as laser therapy. High-intensity laser therapy (HILT) is a recent treatment proposed to reduce musculoskeletal pain; however, there are few studies that prove its effects in reducing neck pain. The aim of this randomized clinical trial is to evaluate the effect of high-intensity laser therapy on pain intensity in patients with chronic nonspecific neck pain. The research will be carried out in the laboratory of physical agents at the Andrés Bello University, Campus Casona de las Condes. Participants will be employers and volunteer students with non-specific chronic neck pain. Participants will be randomized and allocated into 2 study groups: group 1 (HILT and stretching exercises) and group 2 (simulated HILT and stretching exercises). Treatments will be performed twice a week for 4 weeks with 3 assessments: before treatment, at the end of treatment, and 12 weeks after treatment (follow-up). The main results will be the differences in pain pressure threshold (ΔPPT), intensity of pain at rest (ΔRPI) and intensity of pain on movement (ΔMPI). Secondary outcome measures, on the other hand, will include differences in cervical spine range (ΔCROM) and cervical disability (ΔND).
This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic anticancer therapy.
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment
The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms. The main questions it aims to answer are: - How well cenerimod works on top of the treatment already being administered. - How safe cenerimod is for adult patients with Systemic Lupus Erythematosus. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.
- This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. - This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. - The primary objective of the study is to assess long-term safety of isatuximab as study treatment.
The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.
This study have as primary aim "To compare the H. pylori eradication rate between the quadruple bismuth therapy versus the standard triple therapy recommended by the AUGE Clinical Guidelines for Helicobacter pylori eradication treatment in peptic ulcer patients." Briefly, this is a randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists of omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, which consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days
An upper digestive endoscopy diagnostic procedure is undoubtedly a situation that will generate anxiety. The environment, protocols, distance the patient from the family member or partner, which is perceived as a threat to integrity. The objective of the study is to determine the effectiveness of a structured, significant follow-up nursing intervention to reduce anxiety in patients who are going to undergo upper digestive endoscopy in a public hospital in the Biobío Region, year 2021. The methodological proposal will be in a randomized, single-blind, third-party evaluation clinical trial, the intervention will consist of the visual and tactile presence of a significant companion throughout the endoscopic procedure. The sample will be 126 that will make up the experimental and control group. It is hypothesized that patients who have a significant follow-up will obtain 10 points less on the anxiety scale compared to those who did not have the intervention. The data will be collected with the Spielberg state / anxiety test (STAIT) and the Visual Analog Scale (VAS) to measure psychological effects, with vital parameters (pressure, pulse, respiration, saturometry), physiological effects, as well as the effects biochemicals with blood levels of potassium, glycemia and cortisol in saliva and mechanical effects through the monitoring of movements, using a mesh of pressure sensors. The difference-in-difference statistical method will be applied by t student, to analyze the data. The requirements of Emmanuel will be applied to safeguard the ethics of the study. It is hoped that significant follow-up as a nursing intervention will be shown to reduce the anxiety of the patient who is going to undergo an endoscopic procedure.