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NCT ID: NCT05966259 Recruiting - Childhood Obesity Clinical Trials

Management of Childhood Obesity

Start date: September 11, 2023
Phase: N/A
Study type: Interventional

The significant increase in the prevalence of obesity can also be attributed to various social changes, in which the environment (political, economic, social, cultural), and not only the individual and his choices, takes a strategic place in the analysis of the problem and proposed interventions. The food environment can influence the choice and consumption of foods that promote obesity, such as ultra-processed foods (UPA). It is suggested that to intervene to effectively change behavior and eating habits, intensive interventions are needed that consider multiple levels that include the family, school, and community rather than one-off interventions that may not be effective in changing behavior and lifestyle. Regarding the family environment, parents or guardians can assist in the adoption of obesity-related behavioral patterns. It is known that the context of Primary Health Care (PHC) is ideal for actions to prevent diseases and promote children's health, since the PHC professional team is closest to the reality of life of the child, family, and community. We emphasize the importance of this study from the perspective of treatment of childhood obesity, in order to generate scientific evidence and practical subsidies for the implementation of interventions focused not only on the individual, but also in the context of the Unified Health System (SUS). The hypothesis of the study is that there will be a decrease in the consumption of ultra-processed foods (UPA) among children, aged 6 to 10 years, living with obesity and who are treated in primary health care. In addition to encouraging healthy habits such as physical activity and the consumption of in natura and minimally processed foods. The management of childhood obesity is one of the priority topics on the national agenda of SUS's food, nutrition, and health promotion policies.

NCT ID: NCT05963321 Recruiting - Chronic Pain Clinical Trials

Cortical Excitability Modulation With ctDCS in Fibromyalgia.

ctDCS
Start date: June 15, 2023
Phase: N/A
Study type: Interventional

Fibromyalgia is a syndrome characterized by chronic generalized musculoskeletal pain, accompanied by other symptoms such as fatigue, sleep disturbance and depression. Complaints of memory deficit, cognitive dysfunction, headache and gastrointestinal disorders are also common. Although it is a relatively common syndrome, exist a limited effectiveness of the pharmacologycal treatment. However, In the last years new therapeutic and diagnostic options have been sought. This scenario includes the use of different techniques of non-invasive brain stimulation, such as transcranial direct current magnetic stimulation (tDCS) and transcranial magnetic stimulation (TMS), which have already had promising results in reducing pain. Based on the above, the objective of this research is to evaluate the effect of cerebellar tDCS on clinical measures of pain and cortical excitability in patients with fibromyalgia. In this study, the intervention consists of a single tDCS session in which two devices will be used simultaneously. The active electrode will be placed in the cerebellum and/or in the primary motor cortex and the cathode in the contralateral supraorbital region. It is expected that the application of this protocol will be able to have a modulatory effect on clinical pain measures. In addition to producing changes in cortical excitability as a reflection of the integration between the cerebellum-thalamus-cortical pathways.

NCT ID: NCT05959772 Recruiting - Pain Clinical Trials

Transcranial Photobiomodulation as a Therapy for Patients With Parkinson's Disease: Relationship Between Pain and Brain Functional Connectivity (FBM)

FBM
Start date: June 16, 2023
Phase: N/A
Study type: Interventional

Parkinson's disease is a progressive and degenerative neurological movement disorder that affects thousands of people. The disease is characterized by presenting motor and non-motor symptoms, as the disease progresses, it becomes more disabling, making it impossible for the individual to perform simple tasks. A non-motor symptom increasingly reported by patients and undertreated in clinical practice is pain. During the past few decades, possible neural substrates of pain have been studied extensively, resulting in a potential network of connected brain areas that are believed to underlie pain processing and experience. There is no definitive consensus on all areas involved in such a pain network; however, pain-related regions consistently found across all studies include the thalamus, anterior cingulate cortex (ACC), posterior and anterior insula, amygdala, prefrontal cortex (PFC), secondary somatosensory cortex (IBS), and periaqueductal gray (PAG). With the aim of helping to improve the painful condition, non-pharmacological therapies have been studied, and one of them is phototherapy, a non-invasive method used by several areas of health, which has been shown to be increasingly effective in the treatment of decreased pain sensitivity. The present study aims to evaluate the effects of transcranial photobiomodulation in patients with Parkinson's disease. This is a randomized study, in which investigators will analyze the effect of FBM on pain control and on magnetic resonance images to better elucidate the connectivities of pain areas. Afterwards, the researchers will carry out a better elaboration on the treatments of individuals diagnosed with Parkinson's disease, the researchers will evaluate the pain through questionnaires, and the researchers will also evaluate the motor cognitive capacity of these patients before and after the therapy.

NCT ID: NCT05959720 Recruiting - Clinical trials for Chemotherapeutic Toxicity

Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

BRALLA
Start date: September 5, 2023
Phase:
Study type: Observational [Patient Registry]

In this project, the investigators intend to start a prospective registry for patients with newly diagnosed Philadelphia-negative ALL from 16 years old and above in participating centers, provided that all patients will be treated with the same regimen (a pediatric regimen BFM-based incorporating peg-asparaginase). All diagnostic/follow-up (after induction and consolidation blocks) samples will be centrally biobanked at Instituto do Cancer do Estado de Sao Paulo. The main goal of this study is to examine whether the implementation of a pediatric protocol under a prospective registry can increase event-free survival (EFS) and overall survival (OS) of newly diagnosed patients in the participating centers.

NCT ID: NCT05958134 Recruiting - Clinical trials for Diffuse Large B Cell Lymphoma

Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL

Start date: July 15, 2023
Phase:
Study type: Observational

National, multicenter, non-randomized, retrospective observational study (Real World Evidence-RWE) to analyze the epidemiological profile of diffuse large B cell lymphoma, clinical management, treatment in molecular subgroups, progression profile and patient survival outcomes enrolled and treated within the last 6 years (2017 to 2022), in national cancer reference centers.

NCT ID: NCT05957276 Recruiting - Clinical trials for Inherited Retinal Diseases

Global Patient Registry of Inherited Retinal Diseases

EYERD Registry
Start date: August 31, 2023
Phase:
Study type: Observational

The purpose of this study is to better understand the natural history of Inherited Retinal Disease (IRD) and help inform patient management.

NCT ID: NCT05956249 Recruiting - Depressive Symptoms Clinical Trials

Online Group Therapy for Mothers of Babies With Congenital Heart Disease

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

Introduction: Mothers of babies with congenital heart disease tend to have higher levels of depression, stress and anxiety. Currently, psychological support group technology has been a resource increasingly used by health professionals, with a therapeutic objective as an instrument to promote care. Objective: The aim of this study is to evaluate the effectiveness of a group intervention in improving depression, anxiety and the psychological well-being of mothers of babies with congenital heart disease. Methods: Randomized, parallel clinical trial, in which the factor under study will be online group therapy and the outcome the level of depressive symptoms, anxiety and psychological well-being, assessed using the instruments: BECK-II, BAI and Wellness Scale Ryff's psychological well-being at the beginning and after the intervention. The fellow who will reapply the instruments will be blinded to the groups. Patients will be randomized 1:1, with odd numbers assigned to treatment (online group therapy) and even numbers assigned to controls (no online group therapy). The intervention group will have 8 weekly group consultations, psychoeducational and focused on depression, anxiety and psychological well-being. The sample size was calculated at 36 individuals for each group. Data will be analyzed using the statistical program Statistical Package for Social Sciences (SPSS) version 27.0. For comparison between groups, Student's t test or Kruskall-Wallis or Chi-square test will be used. A two-tailed value of p≤ 0.05 will be considered significant. The normality of instrument scores will be evaluated using the Kolmogorov-Smirnov test. Covariance analysis will be performed to assess the influence of initial scores of anxiety, depression and well-being and their changes after intervention. The effect size will also be calculated. Expected results: It is expected to know and describe the population studied with regard to the level of depressive symptoms, anxiety and psychological well-being. In addition to seeking knowledge about the effectiveness of Group Therapy for these variables.

NCT ID: NCT05956145 Recruiting - Clinical trials for Coronary Artery Disease

Effect of Low Dose of Colchicine on Platelet Reactivity

Start date: June 17, 2021
Phase: Phase 3
Study type: Interventional

Inflammation plays an important role in atherosclerosis and the occurrence of ischemic events. Statins, in addition to their lipid-lowering effect, have also documented anti-inflammatory effect that may partly explain their clinical benefit in reducing cardiovascular ischemic events. Colchicine is an orally administered anti-inflammatory drug that has been used for centuries in several anti-inflammatory or autoimmune diseases. Its mechanism of action occurs by the inhibition of tubulin polymerization and the generation of microtubules and by effects on cell adhesion molecules and inflammatory chemokines. However, there are no studies evaluating the in vivo "antiplatelet action" of colchicine in patients with established cardiovascular disease. We will evaluate the effect of low-dose 0.5 mg QD colchicine for 30 ± 3 days on platelet reactivity by MultiplateTRAP. Patients with proven chronic coronary artery disease, that is, documented previous myocardial infarction, will be randomized to receive colchicine 0.5 mg QD or placebo for a period of 30 ± 3 days.

NCT ID: NCT05954702 Recruiting - Esophagus Cancer Clinical Trials

Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

Supercharged
Start date: July 21, 2023
Phase: N/A
Study type: Interventional

Esophagectomy has high rates of morbidity and mortality, in many cases due to esophagus reconstruction. Anastomotic leakage and fistula are the main esophagectomy complications. Many studies underwent to investigate the cause for anastomotic leakage after esophagectomy, however none of them conclude it is related to surgery or suture technique. However, it seems to be triggered by the ischemia caused after stomach mobilization to esophagus reconstruction, or even tension in the anastomosis. Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. In this study researchers will evaluate whether a TRAM flap transfer supercharged is effective on decrease morbidity related to anastomosis ischemia in patients undergoing esophagectomy.

NCT ID: NCT05953155 Recruiting - Low Back Pain Clinical Trials

YOga for Patients With Chronic BACK Pain and Poor PROgnosis

YOBACK-PRO
Start date: July 27, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effectiveness of yoga for patients with chronic low back pain and high risk of poor prognosis. The main question it aims to answer is: - In patients with back pain and high risk of poor prognosis, what is the effectiveness of yoga plus education on reducing pain and disability compared to a control group receiving education alone? A total of 110 patients with chronic low back pain and classified as high risk of poor prognosis according to the Orebro Musculoskeletal Pain Screening Questionnaire (i.e. score ≥ 50 points out of 100) will be recruited for this study. Participants will be randomized into two groups: yoga and control. The yoga group will receive a 3-month course of yoga program consisting of two sessions per week and 3 educational classes. The control group will receive 3 educational classes over a 12-week period. Outcome measures will be assessed at baseline, at post-intervention (i.e. 3-months post randomization) and at 6-month follow up (i.e. 6-months post randomization).