Clinical trials

Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to spontaneous recovery as part of the natural evolution of the pathophysiological process, rather than with the contribution of rehabilitation. Additionally, existing therapies show partial effectiveness on the recovery of UE function, but do not avoid the use of compensatory strategies or alternatives to normal movement. Given this situation, there is an active search for new therapeutic approaches. In this clinical trial the investigators propose a rehabilitation paradigm that promotes the recovery of control of specific planes of movement through the selective restriction of degrees of freedom, simplifying control demands. The investigators sought to test the hypothesis that people with stroke in the early subacute stage and who present alterations in the movement of the upper extremity, a rehabilitation protocol that reduces the degrees of freedom of the UE and trunk, enables greater recovery of the movement of the UE and less use of compensatory movements compared to a protocol without DoF control. The general objective is to demonstrate the effect of training with restriction of the degrees of freedom of UE and trunk, mediated by an exoskeleton and videogames, on the control of the UE.

Acute respiratory infections are common reasons for seeking primary care. Most people recover at home, but some older adults may develop respiratory complications or worsening of long-term health conditions. Clear guidance about safe activity, breathing exercises, symptom monitoring, and when to seek further care may support recovery. The goal of this pilot clinical trial is to assess whether the AIRE respiratory self-care intervention and the planned study procedures can be carried out successfully in adults aged 60 to 80 years who receive care for an acute respiratory infection in a primary care center. The pilot will inform the procedures for a larger randomized clinical trial designed to evaluate whether AIRE can prevent complications. The main questions this pilot study aims to answer are: * Can eligible participants be successfully recruited and enrolled? * Can participants complete the 14-day follow-up and daily self-report diary? * Can the AIRE intervention be delivered as planned? * Can participants assigned to AIRE follow the respiratory self-care recommendations and breathing exercises? Researchers will also explore whether participants who receive AIRE experience fewer respiratory complications within 14 days than participants who receive usual care. The pilot study is not designed to provide a definitive test of the clinical effectiveness of AIRE. Participants will be randomly assigned to one of two groups. Participants in the AIRE group will receive usual care plus a respiratory self-care session. The session will include guidance about hydration, safe daily activity, avoidance of prolonged bed rest, warning signs, and simple breathing exercises. Participants will also receive supporting educational material. Participants in the control group will receive usual care without the AIRE intervention. Participants in both groups will: * Receive telephone follow-up during the 14 days after enrollment * Record their symptoms, daily activities, and use of health services in a self-report diary * Report any new medical visits, hospital admissions, or respiratory complications The respiratory complications assessed will include sinusitis, bronchitis, pneumonia, and worsening of a long-term health condition. The findings will help researchers identify changes needed before conducting the larger clinical trial.

Chronic low back pain can affect daily activities and may be influenced by how people understand pain, their fear of movement, and their responses to stressful or uncertain physical activities. This clinical trial will evaluate whether a 6-week program combining pain science education with graded exposure to movement is more effective than usual physical therapy for adults with chronic low back pain. Participants will be randomly assigned to one of two groups: pain science education combined with graded exposure to movement, or usual physical therapy. The study will assess changes in pain, disability, fear of movement, and pain-related thoughts. It will also examine physiological responses to stress and muscle activity while participants perform a lifting task. The study aims to determine whether combining education about pain with gradual exposure to feared movements can improve clinical outcomes, physiological responses to stress, and motor performance in people with chronic low back pain.

Population aging has increased the number of older adults exposed to interventions with high physiological demand, which are associated with frequent adverse outcomes such as delirium, organ dysfunction, and delayed functional recovery. Current clinical tools, such as frailty assessments, help identify higher-risk populations but do not adequately explain the marked individual variability in recovery or accurately predict who will develop complications. This variability may be partly explained by individual resilience, defined as the ability to recover toward, return to, or even surpass a prior functional state after an acute stressor. Evidence suggests that biological mechanisms related to aging influence resilience; however, biomarkers and integrated clinical models capable of characterizing and potentially modulating resilience in humans remain limited. Therefore, a standardized clinical platform is needed to characterize physiological resilience and its determinants, generating actionable knowledge to improve risk stratification, guide interventions, and optimize recovery in older adults. To this end, a single-center prospective cohort study will be conducted at Clinica Bicentenario Santiago, including individuals aged ≥65 years who are independent or have mild dependency and are undergoing elective cardiac surgery requiring sternotomy for valvular and/or coronary artery disease, recruited between 2026 and 2027. Participants will undergo a baseline assessment 2-3 weeks before surgery; an early postoperative assessment focused on the systematic recording of clinical outcomes, including delirium and organ dysfunction; and longitudinal follow-up to characterize recovery after discharge. Follow-up assessments will include frailty, intrinsic capacity (the composite of an individual's physical and mental capacities across the cognitive, locomotor, psychological, vitality, and sensory domains), functional status, health-related quality of life, and perceived fatigability, according to the prespecified assessment schedule. In addition, blood samples will be collected at three time points (baseline, 24 hours postoperatively, and one month after surgery) to measure plasma levels of growth differentiation factor 15 (GDF-15), a biomarker associated with aging-related biological stress and systemic responses to tissue injury. It is projected that at least 75 participants will be recruited over a 12-month period, allowing characterization of baseline clinical and functional profiles, the frequency of postoperative complications and organ dysfunction, trajectories of recovery, and associations between baseline characteristics, biological markers, and subsequent recovery outcomes.

The goal of this clinical trial is to learn if a combined antioxidant therapy (CAT) can reduce heart damage caused by the return of blood flow after blocked arteries are reopened in adults with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). It will also learn about the safety of this treatment. The main questions it aims to answer are: 1. Does combined antioxidant therapy lower infarct size, measured by cardiac magnetic resonance imaging (CMR), compared with placebo? 2. Does combined antioxidant therapy improve heart function, blood biomarkers of heart injury, and short-term clinical outcomes? 3. What problems do participants have when receiving the therapy? Researchers will compare CAT to placebo (a look-alike infusion with no active drug) to see if the treatment lowers infarct size after STEMI. Participants will: * Be randomly assigned to receive either CAT or placebo * Receive the study infusion before and during primary PCI, in addition to standard treatment for STEMI * Have blood tests to measure heart injury, oxidative stress, inflammation, and drug levels * Undergo cardiac magnetic resonance imaging about 3 to 7 days after STEMI. * Be followed for clinical outcomes and safety for 30 days.

This clinical trial evaluates whether an optimized exposure-based treatment improves long-term outcomes for adults with anxiety disorders. Specifically, it examines whether Expectancy Focused Exposure (EFE), based on the inhibitory learning model, is more effective than Anxiety Focused Exposure (AFE) in reducing anxiety symptoms and preventing the return of fear over time. The study includes adults aged 18 years and older diagnosed with an anxiety disorder, including social anxiety disorder, specific phobia, generalized anxiety disorder, and panic disorder with or without agoraphobia. Anxiety disorders are highly prevalent and can significantly interfere with daily functioning, work performance, and interpersonal relationships. Exposure therapy is a central component of cognitive behavioral treatment for anxiety disorders. Traditional exposure approaches often focus on reducing anxiety during exposure sessions, but many individuals experience a return of fear after treatment. New theoretical models suggest that exposure may be more effective when designed to violate threat expectations and strengthen inhibitory learning. Participants will be recruited in sequential cohorts and randomly assigned to immediate treatment or a brief waitlist before treatment begins. Those assigned to the waitlist will start treatment at the next study step. When treatment begins, participants will receive either EFE or AFE. Both treatments consist of approximately 10 weekly individual psychotherapy sessions delivered by trained therapists. Participants will complete clinical assessments before treatment, during treatment, immediately after treatment, and at 6, 12, and 18 months after treatment completion. In AFE, exposure exercises are organized along an anxiety hierarchy and focus on reducing anxiety responses through repeated confrontation with feared stimuli. In EFE, exposure focuses on identifying and testing threat expectations, and exercises are designed to maximize expectancy violation and strengthen inhibitory learning. Potential risks include temporary emotional discomfort during exposure exercises. All sessions will be conducted by trained clinicians who monitor participant safety throughout the study. The results may help improve exposure-based treatments for anxiety disorders by identifying strategies that enhance long-term outcomes and reduce relapse.

This study aims to evaluate the effectiveness of NeoMayor, a mobile health (mHealth) intervention designed to improve cardiovascular health among older adults at elevated cardiovascular risk in Chile. NeoMayor is a smartphone-based application that provides personalized guidance on physical activity, diet, sleep, and mental well-being through a multidomain lifestyle approach. This multicenter randomized controlled trial will enroll community-dwelling older adults aged 55 to 75 years recruited from primary healthcare centers in urban and rural settings. Participants will be randomized in a 2:1 ratio to either the NeoMayor intervention or a control group receiving standard health information and usual care. The intervention duration will be four months. The primary objective is to determine whether the NeoMayor intervention improves cardiovascular health as measured by the Life's Essential 8 Cardiovascular Health Index. Secondary objectives include evaluating changes in cognitive performance, depressive symptoms, anxiety symptoms, quality of life and physical performance outcomes. The study will also assess feasibility and adherence to digital intervention.

Hemophilia is an inherited bleeding disorder that is commonly associated with chronic joint pain, reduced physical function, and decreased quality of life. Pain science education combined with exercise therapy has shown beneficial effects in people with chronic musculoskeletal pain; however, its effectiveness in people with hemophilia remains largely unknown. Telerehabilitation may improve access to rehabilitation by reducing geographical and transportation barriers, but its effectiveness compared with face-to-face delivery has not been established in this population. This randomized controlled non-inferiority trial will compare a 6-week multimodal telerehabilitation program consisting of pain science education and therapeutic exercise with an equivalent face-to-face program in adults with hemophilia and chronic pain. Participants will be randomly assigned to one of the two interventions. Clinical outcomes will be assessed before and after the intervention by an assessor blinded to group allocation. The study aims to determine whether telerehabilitation provides clinical outcomes that are not inferior to those achieved with conventional face-to-face rehabilitation.

This study is a randomized controlled field experiment embedded in the medical institution Early Diagnosis Program in Chile. Participants with two exams pending (a cancer screening test and a chronic disease test for diabetes and dyslipidemia) will be randomly assigned across a 3 × 3 factorial design: three message framing conditions (Basic, Risk/Importance, Peace of Mind) crossed with three exam-type conditions (cancer screening only, chronic disease test only, or both exams). Participants with only a cancer screening pending will be assigned to the 3 framing conditions and be encouraged to get the cancer screening. In both cases, participants are assigned to each experimental arm at twice the rate of an additional arm receiving the standard message currently used by the medical institution. This standard-message arm is included for operational purposes, is not part of the pre-specified analyses, and is thus not described in the "Arms and Intervention" section (or counted for "number of arms").

The goal of this clinical trial is to learn if omega-3 fatty acid supplements (n-3 PUFAs) can help reduce inflammation and promote intestinal healing in adults newly diagnosed with celiac disease (CD). Celiac disease is a chronic autoimmune disorder where eating gluten-a protein found in wheat-triggers an immune response that damages the lining of the small intestine. This damage causes inflammation and symptoms such as stomach pain, diarrhea, and nutrient absorption problems. The only current treatment is a strict gluten-free diet (GFD), which can help most people recover, but some continue to have inflammation and symptoms. This study will test whether supplementing with 2.4 grams of n-3 PUFAs daily for three months, alongside starting a gluten-free diet, reduces inflammation in the blood and intestine more effectively than the gluten-free diet alone. Participants will: Be adults recently diagnosed with celiac disease who have not yet started a gluten-free diet Be randomly assigned to one of two groups: One group will receive omega-3 supplements containing 2,400 mg of n-3 PUFAs daily (2,000 mg DHA and 400 mg EPA) The other group will receive a placebo (a pill with no active ingredients that looks like the supplement) Take the assigned supplement every day for 3 months while following a supervised gluten-free diet Visit the clinic regularly for checkups, blood tests, and monitoring of symptoms and diet adherence Provide blood and stool samples before and after the intervention to measure inflammation and changes in gut bacteria A subgroup of participants will undergo small intestinal biopsies to assess local inflammation and healing The study aims to answer these main questions: Does omega-3 supplementation change the fatty acid composition in blood cells? Does it reduce markers of inflammation in the blood and small intestine? Does it improve the diversity and health of gut bacteria in the intestine? Does it help the small intestine heal faster compared to diet alone? Researchers will measure inflammation by analyzing immune signaling pathways, oxidative stress markers, and antioxidant activity in blood cells. They will also study the composition of the gut microbiota and its metabolites. These detailed measurements will help understand how omega-3 fatty acids may influence the immune response and gut health in celiac disease. This is a randomized, double-blind, placebo-controlled crossover study. This means participants and researchers will not know who receives the supplement or placebo during the study period, reducing bias and improving the reliability of the results. This study is important because it could offer a simple, additional treatment to improve recovery in celiac disease beyond the gluten-free diet. If omega-3 supplements are shown to reduce inflammation and support healing, they could become a valuable part of managing this chronic condition. Participation is voluntary, and participants can leave the study at any time without affecting their medical care. All participants will be closely monitored to ensure safety throughout the study.

This study evaluates the effectiveness of price discounts in encouraging patients to schedule dental check-ups. Patients will be randomized to receive WhatsApp messages offering a preventive dental check-up at different price levels with or without a discount coupon for future dental treatments.

The goal of this clinical trial is to study whether physical therapy can reduce NLRP3 inflammasome activation and muscle atrophy in patients with critical illness myopathy (CIM). It will also explore the role of NLRP3 inflammasome in the pathophysiology of CIM. The main questions this study aims to answer are: Is NLRP3 inflammasome activation associated with muscle atrophy through the upregulation of atrogenes? Does physical therapy attenuate NLRP3 inflammasome activation in skeletal muscle, thereby contributing to the prevention or reduction of muscle atrophy in CIM? Researchers will compare enhanced physical therapy using servo-assisted bed cycling (Motomed Letto®) in critically ill patients at risk of developing CIM during the early phase of ICU stay to conventional physical therapy (standard physiotherapy), to assess whether physical therapy reduces NLRP3 inflammasome activation and muscle degradation. Participants will: Be randomized to receive either conventional physical therapy or enhanced physical therapy (Motomed Letto®) for 7 consecutive days. A control group of patients without CIM will also be included. Undergo assessments of NLRP3 activity, muscle atrophy markers, and transcriptomic profiles from serum and vastus lateralis muscle biopsies. Be clinically evaluated using the SOFA scale and muscle ultrasound for CIM diagnosis. Be followed up for changes in muscle strength and physical functionality. Provide sociodemographic and clinical information to be recorded throughout the study.

The goal of this observational study is to examine JAK1/2 pathway activation in gingival tissues from adults with healthy gingiva and those with inflamed gingiva (periodontitis). The main question it aims to answer is: Is the JAK1/2 pathway overactivated in periodontitis compared to health? Participants with healthy gingiva and periodontitis will donate gingival tissue to study the JAK1/2 pathway. All participants wil receive diagnosis and treatment of the gingival condition.

The goal of this observational study is to determine whether macrophage/monocyte mediated inflammatory signaling contributes to reduced anesthetic requirements in older adults undergoing major abdominal surgery. The main questions it aims to answer are: * Is there a difference in anesthetic dosing requirements (minimum effective dose) between young and older patients undergoing major abdominal surgery? * How do electroencephalographic (EEG) signatures under anesthesia correlate with age and systemic inflammatory markers? * Is there an association between age, levels of circulating inflammatory cytokines, and monocyte/macrophage phenotypes with anesthetic requirements? If there is a comparison group: Researchers will compare older adult patients undergoing major abdominal surgery to younger adult patients undergoing major abdominal surgery to see if macrophage/monocyte-mediated inflammatory signaling influences anesthetic sensitivity and the risk of postoperative neurocognitive complications in the older population. Participants will: * Receive general anesthesia for major abdominal surgery, with continuous recording of anesthetic dose requirements. * Undergo electroencephalographic (EEG) monitoring during the anesthetic period. * Provide blood samples for the measurement of circulating inflammatory cytokines and the assessment of monocyte phenotypes. * Provide peritoneal tissue samples (collected during surgery) to evaluate tissue macrophage populations. * Provide cerebrospinal fluid (CSF) samples to assess biomarkers of blood-brain barrier permeability.

The goal of this observational study is to determine the relationship between brain activity patterns and recovery time in adult patients (ages 35-50, ASA I-II) undergoing elective general anesthesia. The main question it aims to answer is: \- Does a lower magnitude of intraoperative alpha wave power correlate with a longer time for patients to emerge from general anesthesia? Participants will: * Undergo a standardized general anesthesia (GA) protocol for elective surgery. * Have their EEG activity recorded using a standard clinical BIS™ anesthetic depth monitor during the procedure. * Have their time to awakening precisely measured after the cessation of anesthetic gases.

The goal of this clinical trial is to determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol in adult patients (18-60 years) candidates for elective surgery who require remifentanil and American Society of Anesthesiology (ASA) classification I or II. The main question it aims to answer are: • To determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol. Participants will undergo general anesthesia with remifentanil and propofol sequentially. After loss of consciousness, remifentanil will be adjusted to a medium or high concentration randomly and it will be determined at what concentration of propofol the burst suppressions are generated. Then, the concentrations of propofol that generate burst suppression associated with either a medium or high concentration of remifentanil will be compared.

The goal of this observational study is to learn about the effect of general anesthetic on spatial memory in adults who will undergo to an elective surgery. The main question it aims to answer is: • A surgical event under general anesthesia with sevoflurane transiently impairs spatial memory in humans and induces an increase in inflammatory cytokines. Participants will perform a virtual maze test and plasma samples will be taken before and after surgery.

This pilot study aims to evaluate the feasibility of implementing immersive virtual reality (VR) in cognitive rehabilitation for adults with post-stroke cognitive impairment receiving outpatient therapy. Participants will use a head-mounted display and interactive software to engage in gamified cognitive exercises that simulate memory, attention, and executive function tasks. The intervention consists of 10 sessions, delivered two to three times per week over a period of approximately four weeks. The study will assess multiple feasibility indicators, including the recruitment rate based on eligibility criteria, the safety and tolerability of VR sessions for participants, and the usability and satisfaction reported by occupational therapists administering the intervention. Additionally, exploratory outcomes include changes in global cognition and specific cognitive domains, as well as self-reported quality of life. Adverse effects related to VR use will be tracked. This pilot study will help inform the design and implementation of future, larger-scale clinical trials.

The goal of this observational study is to evaluate the feasibility and inter-rater reliability of muscle and peripheral nerve ultrasound for the early detection of ICU-acquired weakness (ICU-AW) in critically ill patients. The main questions it aims to answer are: Can ICU physical therapists consistently measure muscle and nerve ultrasound variables such as muscle thickness, cross-sectional area, pennation angle, and echogenicity in critically ill patients? Do clinical scales (MRC-SS and FSS-ICU) show inter-evaluator agreement and correlate with ultrasound findings? Participants are adult ICU patients at Clínica INDISA who are undergoing routine neuromuscular assessments by trained physical therapists. Each patient will be evaluated by three independent raters using ultrasound and standardized clinical scales. Data will be collected and analyzed to determine inter-rater reliability and correlations between clinical and imaging findings.

Anemia is a highly prevalent condition in the surgical population (1, 2). On the other hand, the oncology population is at higher risk of developing anemia due to specific treatments for the disease, such as chemotherapy and radiotherapy. Preoperative anemia has been associated with an increased risk of postoperative morbidity and even mortality (3). Despite this, the prevalence of preoperative anemia in the Chilean oncology population has not been quantified. To answer this question, a retrospective cohort study was designed between January and December 2022 to quantify the prevalence of anemia in the surgical population of the National Cancer Institute. In addition, the impact on morbidity and mortality at 30 days, 6 months, and 1 year will be evaluated. Statistical analysis will be performed using R. Studio Version 2023.09.1+494 (2023.09.1+494).

The objective of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of glycated hemoglobin levels in adult patients with concurrent type 2 diabetes mellitus and periodontitis. Non-surgical periodontal treatment and the application of a quality of life survey will be performed and then controls will be carried out for 1 year.

In a recent study, direct periarticular local anesthetic infiltration (PAI) showed a greater incidence of early quadriceps weakness (33% at 3 hours and 13% at 6 hours) than pericapsular nerve group block (PENGB) in total hip arthroplasty (THA) but, in turn, demonstrated a statistically significant better pain control. Additionally, PENGB could not completely circumvent motor compromise either, particularly at 3 hours (20% incidence), probably secondary to an injectate migration towards the femoral nerve. Posteriorly to this publication, a cadaveric trial looking into the maximum effective volume that spared the femoral nerve resulted in 13.2 mL. This newer evidence led to the design of a strategy that combines both interventions, aiming to obtain the best of them and have a solid alternative for those cases where very early mobilization is pursued. Thus, it is hypothesized that posterior PAI added to a low-volume PENGB (10mL) represents a superior alternative to PAI in terms of strength preservation and provides effective analgesia during the first 24 postoperative hours after THA.

There are several techniques for performing minimally invasive urological surgeries. Among them, laparoscopic surgery, robotic surgery, and lumboscopy are noteworthy (1). The medical literature extensively documents the impact of pneumoperitoneum a procedure involving the insufflation of the peritoneal cavity with carbon dioxide (CO2), which is essential for laparoscopic and robotic surgeries on ventilatory mechanics. As an alternative, CO2 insufflation into the retroperitoneum, as utilized in lumboscopic surgery, has been proposed. This approach is believed to exert a lesser impact on respiratory function and pulmonary mechanics. However, it is important to note that no conclusive evidence has yet been found to support this claim. Assessing the impact of lumboscopic surgery could help establish it as a viable alternative for patients with pulmonary conditions, where mechanical ventilation poses significant challenges. To explore this possibility, a physiological study was designed to compare the effects of laparoscopic and lumboscopic surgery on ventilatory mechanics.

High positive end-expiratory pressure (PEEP) levels required to achieve clinical benefits may increase ICP and reduce cerebral perfusion pressure (CPP) in patients at risk of intracranial hypertension. However, individualizing ventilation parameters is essential for each patient. Among protective ventilation strategies, PEEP is key to preventing alveolar collapse. The PEEP level that minimizes alveolar collapse while avoiding overdistension of the pulmonary parenchyma is known as the Best PEEP. This study aims to evaluate the application of Best PEEP in cranial neurosurgery.

Endothelial dysfunction is a cardiovascular disease hallmark. After non-cardiac surgery, cardiovascular events correlate with surgical outcomes. Understanding the role of endothelial function in these events is crucial. This research aims to study endothelial function and its association with cardiovascular events.