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NCT ID: NCT05291208 Recruiting - Clinical trials for Mild Cognitive Impairment

Clinical Trial Through Combined tACS Therapy in Patients With Mild Cognitive Impairment

Start date: January 26, 2022
Phase: Phase 2
Study type: Interventional

The aging of the population has led to an increase in the prevalence of disabling and high-cost diseases, such as dementia and Mild Cognitive Impairment (MCI). The latter can be considered a prodromal phase of some dementias and a critical stage for interventions to postpone the impairment of functionality and thus maintain a better quality of life. A cognitive function to intervene in working memory (WM) since it represents the fundamental component of executive functions and is the gateway to maintaining long-term memory. This project proposes an intervention to enhance WM in these users, combining cognitive training with non-invasive brain stimulation, specifically transcranial electrical stimulation of alternating current (tACS). This proposal arises from recent evidence showing that it is possible to increase the capacity of WM in users with MCI through cognitive training. Along with this, tACS has been proposed as a specific neuronal plasticity inducer for the oscillatory pattern required for each mental process. WM is a process particularly susceptible to being enhanced by this technique, as the underlying electrophysiological oscillatory patterns of this process are well described. Thus, tACS would act as a potentiator of the residual capacity of WM in patients with neurodegenerative diseases. This study is a phase II randomized, double-blind clinical trial with a 3-month follow-up. The study will be of 62 participants diagnosed with MCI over 60 years from Valparaíso, Chile. Participants will receive intervention that will combine 12 cognitive training sessions with non-invasive brain stimulation, specifically tACS. Depending on the intervention group to which they will be assigned, in 8 of these sessions, participants will receive either tACS or sham stimulation. Sessions will last approximately 1 hour and take place twice a week, over six weeks. The primary outcomes will be the electroencephalographic measurements, and the secondary effects will be cognitive assessments of WM. The outcomes will be performed before, immediately after, and three months after the end of the intervention. The outcomes of this trial will add evidence about the benefits and feasibility of an intervention that combines cognitive training with non-invasive brain stimulation. The objective is to contribute tools for optimal cognitive treatment in patients with MCI. To enhance WM capacity, postpone the impairment of functionality, and obtain a better quality of life.

NCT ID: NCT05288478 Enrolling by invitation - Clinical trials for Epidermolysis Bullosa

Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in People With Epidermolysis Bullosa.

Start date: April 6, 2022
Phase: Phase 2
Study type: Interventional

Inherited Epidermolysis Bullosa (EB) is a disorder that causes skin fragility and blistering in skin and mucous membranes, including the mouth. Recurrent oral blisters and ulcer result in oral pain and discomfort. Dentoxol® is a mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. It has significant potential to reduce EB related oral symptoms. This study includes people living with Inherited Epidermolysis Bullosa aged 6 and above; and is aimed at determining the efficacy of two different dose regimens of Dentoxol mouthrinse in reducing oral symptoms.

NCT ID: NCT05287919 Completed - Critical Illness Clinical Trials

Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects. Objective: to compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients. Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were strength, functionality, independence for activities of daily living, quality of life, and total days hospitalized.

NCT ID: NCT05281536 Completed - ARDS Clinical Trials

Effects of Trunk Postural Change on CO2 Removal Efficiency in ARDS Patients: Quasi-experimental Study

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

OBJECTIVES: The trunk inclination from semirecumbent to lying supine improves lung mechanics and reduces end-expiratory lung volume in Acute Respiratory Distress Syndrome (ARDS) patients. Besides, it can improve the ventilatory ratio and PaCO2, although the effects and mechanisms are not entirely elucidated. Therefore, this study aimed to evaluate the effects of trunk tilt from 45° to 10° on CO2 removal efficiency. DESIGN: Quasi-experimental study. SETTING: A medical ICU in Chile. PATIENTS: Twenty-two patients with ARDS. INTERVENTION: Patients in pressure-controlled ventilation underwent three 60-minute steps in which trunk inclination was changed from 45° (baseline) to 10° (intervention) and back to 45° (control) in the last step. Respiratory mechanics, arterial blood gas analysis, dead space by volumetric capnography, and electrical impedance tomography were recorded.

NCT ID: NCT05275140 Completed - Clinical trials for Healthy People Programs

Adapted Taekwondo on Health Status in Older Women

TKD&Aging
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The main aim of this project is to analyze and compare the effects of an adapted taekwondo program with respect to multi-component training and walking program on health status in independent older women. The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach. The sample will be 64 women without health problems, between 60 and 65 years old and who decide to participate voluntarily. The participants will be randomized and distributed into four groups: experimental group 1 (adapted taekwondo), experimental group 2 (multi-component training), experimental group 3 (walking program) and a control group (no intervention). Assessments will consist of: systolic and diastolic blood pressure with automatic blood pressure monitor; lipid profile with the Cardiochek meter; frequency of food consumption with the modified dietary habits survey for older people; body composition by direct anthropometry and bioimpedance; cognitive status with the survey of memory, phonetic fluency and temporal-spatial orientation (in Spanish, MEFO); brain activity by means of surface electromyography; quality of life perception with the Health Survey Short Form (SF-36) version 2; physical-functional fitness with the Senior Fitness Test; handgrip strength with a hydraulic dynamometer; and postural balance with a force platform. Assessments will be performed before the 16-week intervention and after the intervention. To analyze the pre-and post-intervention results, repeated measures ANOVA will be applied for group factors (EG1 vs. EG2 vs. EG3 vs. CG) and time (pre-and post-intervention) with the Bonferroni post-hoc test; the reliability of the evaluations will be verified by means of the coefficient of intraclass correlation, and the inter-individual variability to the intervention (responders vs. non-responders) will be calculated using the technical error of measurement. The expected results indicate that adapted taekwondo produces significantly greater effects and a more favorable inter-individual response in cognitive status, brain activity, quality of life perception and postural balance compared to a multi-component training and walking program, in addition to producing similar effects at the group and inter-individual level for blood pressure, lipid profile, frequency of food consumption, body composition and physical-functional fitness in independent older women.

NCT ID: NCT05264909 Recruiting - Parkinson Disease Clinical Trials

Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Parkinson's disease affects 1 in 100 people over the age of 60. Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia Over time, different strategies have been developed to treat and slow the progress of the disease, including pharmacological, rehabilitative and even surgical treatments. Transcranial direct current stimulation (tDCS) is a brain stimulation technique that delivers a low-intensity electrical current to the scalp, usually between 1 and 2 mA over approximately 5 to 30 minutes. The tDCS technique is used with the aim of enhancing a specific brain activity through the neuromodulation of neuronal excitability. In pathologies such as PD, these therapies have been shown to induce immediate after-effects in the brain that translate into reduced gait freezing and improvements in executive function and mobility. In addition, the combined effects of tDCS and physical therapy on the walking ability of PD patients have been studied, where it was shown that anodic tDCS and physiotherapy could be used as a combination treatment to improve patients' gait speed. Another potential therapeutic tool in the treatment of PD consists of the use of sound stimulation with beat frequencies similar to the step. Specifically, this technology is characterized by presenting two tones of different frequencies for each ear in order to influence the mood and mental performance of the listener. This protocol is proposed in order to evaluate the effect of tDCS combined with auditory and binaural stimulus strategies during gait therapy in patients with Parkinson's disease.

NCT ID: NCT05264467 Completed - Colorectal Surgery Clinical Trials

Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis

Start date: March 12, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Anastomotic leak rate in colorectal surgery is estimated between 4 and 20 percent. Leukocyte and and platelet-rich fibrin plasma (L-PRF) is second generation platelet concentrate whose application in colorectal anastomosis in animals has shown promising results that suppose a lower leakage rate. The objective of this study was to assess the feasibility of using L-PRF in colorectal surgery and to determine the incidence of anastomotic leakage after colorectal anastomosis.

NCT ID: NCT05261399 Recruiting - Carcinoma Clinical Trials

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

SAFFRON
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib.

NCT ID: NCT05255991 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

TETON-2
Start date: October 4, 2022
Phase: Phase 3
Study type: Interventional

Study RIN-PF-303 is a multinational study designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.

NCT ID: NCT05254743 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

BRUIN-CLL-314
Start date: July 22, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.