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NCT ID: NCT05475691 Recruiting - Clinical trials for Spinal Muscular Atrophy

Longitudinal Data Collection in Pediatric and Adult Patients With Spinal Muscular Atrophy in Latin America

RegistrAME
Start date: August 17, 2022
Phase:
Study type: Observational [Patient Registry]

The natural history of SMA patients has changed, due to the improvements in treatment and technological advances. The systematic collection of data from routine clinical practice in multiple Latin American countries, harmonized to an internationally aligned core data set, is important to advancing the understanding the natural history of disease in the region and the influence of different drug treatments on patient outcomes. These data are critical to improving the care of these patients. So far, clinical trials regarding therapeutic approaches for SMA patients only cover a subgroup of the broad spectrum of severity of SMA. Thus, there is a strong need to monitor the full range of treated and untreated SMA patients in a real-world context.The aim of this study is to set up a regional healthcare provider (HCP) entered registry. The planned SMA registry will provide an online platform to collect longitudinal data on SMA patients across Latin America to achieve a better understanding of the clinical characteristics of SMA patients, the natural history of the disease, the use of DMTs and patients' outcomes, as well as to support further research projects and regional data generation.

NCT ID: NCT05414695 Active, not recruiting - Myofascial Pain Clinical Trials

Effect of Acupuncture on Craniomandibular Pain of Myofascial Origin.

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

Myofascial pain is one of the most prevalent conditions within temporomandibular disorders. Despite its high prevalence, health systems pay insufficient attention to it. Patients frequently receive multiple unnecessary and sometimes aggressive treatments. In this context, acupuncture has been studied as a plausible therapy for these conditions. However, researchers have encountered various methodological difficulties when demonstrating its actual effect. The main historical challenge in this area involves the difficulties inherent to using appropriate acupuncture controls such as placebos that allow for double blinding and cause minimum tactile stimulation. In a previous study, a validated an improved novel placebo acupuncture non-penetrating device with double blinding capability was presented. This project will allow to test the performance of this new placebo acupuncture device in a clinical experimental setting. The study will try to determine the actual effectiveness of acupuncture in treating craniomandibular pain of myofascial origin. The design will be a randomized, triple blind, placebo controlled, crossover clinical trial. The protocol follows the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) recommendations, and ethical approval was obtained. The central hypothesis is that acupuncture will be more effective than a placebo. Another hypothesis is that neither patients nor acupuncturists will be able to distinguish real acupuncture devices from placebo devices. The study will include consecutive patients diagnosed with pain in the craniomandibular region of muscular/myofascial origin according to accepted criteria. Sample size calculations were made with the assumption of an 80% power and a statistical difference accepted at the 5% level. A total of 60 patients will be included. Patients will be randomly divided into two groups: real acupuncture or placebo. Five sessions will be performed on each patient on a weekly basis. The total time for each intervention will be 30 minutes. A crossover design will be applied after a "washout" period of 14 days. Outcome measures will include pain, stress levels, quality of life, and mandibular dynamics, using validated and published criteria. Baseline measurements will be taken pre-treatment and at each treatment session. Follow-up outcomes will be measured after three and six months. A strict protocol for bias control will be followed. The triple-blind design will prevent the patient, the acupuncturist, and the person performing the statistical analysis from knowing what type of treatment each patient receives each time. Examiners will be calibrated and blinded to the treatment status. Data will be analyzed using a generalized mixed model framework and logistic regression models. Also, Fisher's exact test will be used to analyze the devices' blinding capability.

NCT ID: NCT05295641 Recruiting - Heart Failure Clinical Trials

American Registry of Ambulatory or Acute Decompensated Heart Failure

AMERICCAASS
Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to better characterize and understand the population of patients with ambulatory or acutely decompensated heart failure in the American continent, getting to know their sociodemographic, clinical and paraclinical characteristics

NCT ID: NCT05169164 Recruiting - Clinical trials for Postoperative Complications

Latin American Surgical Outcomes Study

LASOS
Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

Methods: International, seven-day observational cohort study of complications following elective or emergency surgery. Objectives: To provide detailed data describing post-operative complications and associated mortality. Number of participants: Our aim is to recruit as many patients from as many hospitals as possible in Latin American nations. Eligible countries for participation: Countries and dependencies in Latin America that are situated in the area stretching from the northern border of Mexico to the southern tip of South America, including the Caribbean. Inclusion criteria: all adult patients aged 18 years or older undergoing elective or emergency surgery during the seven-day study period with a planned overnight stay. Exclusion criteria: patients who are undergoing planned day-case surgery or radiological procedures. Statistical methodology and analysis: Single and multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors. A single final analysis is planned at the end of the study. A pre-defined analysis will focus on outcomes of patients who have undergone caesarean section. Study duration: Each nation will select a 7-day period between 1st April and 31th October 2022.

NCT ID: NCT05087160 Completed - COVID-19 Pandemic Clinical Trials

Socioeconomic Inequalities Exacerbated by Mitigation Measures to COVID-19 and Differences in Prematurity Prevalence

Start date: August 1, 2021
Phase:
Study type: Observational [Patient Registry]

Objective: to assess the perinatal results in Uruguay during the semester of successful control of the COVID 19 pandemic to evaluate the impact of the crises in the public and private sub sectors of the Health System. Methodology: An analytical observational study was carried out, comparing the semesters from March 15 to September 30, 2019 (year prior to the COVID 19 pandemic) with the same period 2020 (year of the COVID 19 pandemic), in the 2 sub sectors of public and private health care.

NCT ID: NCT04994756 Recruiting - Stroke Clinical Trials

Stroke Thrombectomy and Aneurysm Registry

STAR
Start date: September 17, 2019
Phase:
Study type: Observational [Patient Registry]

This international multi-center registry is used to collect existing information and outcomes for patients undergoing an operation for treatment of injuries to the brain including the blockage of blood flow to an area of the brain, an abnormal ballooning of an artery, abnormal tangling of blood vessels, abnormal formation of blood vessels, tearing of vein, and bleeding in the brain. This information is used to help predict outcomes that undergo an operation for treatment of the above-listed brain injuries. Additionally, the information is used to compare techniques and devices' effects on technical and clinical outcomes.

NCT ID: NCT04846244 Recruiting - Clinical trials for Radiographic Axial Spondylarthritis (r-axSpA)

A Study of the Change in Early and Sustained Pain Control in Radiographic Axial Spondylarthritis in Adult Participants Receiving Upadacitinib

UPSTAND
Start date: April 30, 2021
Phase:
Study type: Observational

Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. Despite this, there is a lack of detailed data and knowledge on pain in radiographic-axial spondyloarthritis (r-axSpA), including pain types, how it is localized, and how these different facets of pain are impacted by treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in radiographic axSpA participants. Upadacitinib is being developed for the treatment of r-axSpA. Approximately 877 adult participants with activer-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. The overall duration of the study is approximately 30 months. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

NCT ID: NCT04764188 Recruiting - NSCLC Clinical Trials

An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

ReAlec
Start date: May 10, 2021
Phase:
Study type: Observational

This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.

NCT ID: NCT04666597 Recruiting - Clinical trials for Dental Caries in Children

Pandemic-adapted Caries Care Multicentre Case Series

Start date: November 15, 2020
Phase:
Study type: Observational

TThe current understanding of dental caries has not been completely transferred into the clinical practice to control caries lesion progression (severity / activity) and the individual risk of caries. This situation led to the development of the CariesCare International CCI Caries Management System (2018), derived from ICCMS™- International Caries Classification and Management System (2012) and the ICDAS - International Caries Detection and Assessment System (2002) in a consensus among more than 45 cariologists, epidemiologists, public health professionals, researchers and cliniciansfrom all over the world. The consensus aimed to guide dentists and dental teams in clinical practice, facilitating the control of the caries process and the maintenance of oral health in their patients. The general lack of implementation of an updated management of dental caries is evident in Colombia, in the survey of 1094 clinicians, teachers and students, failures were reported to adopt related behaviours, motivation barriers (remuneration), opportunity (in terms of relevance, physical/infrastructure resources, time) and training. As an additional barrier, the Colombian Chapter of the Alliance for a Cavity-Free Future (ACFF), evidences the absence of a facilitating Oral Health Record (OHR), this situation lead to stablish a new Alliance between the Ministry of Health and Social Protection (MSPS) and the AFLC to develop an inter-institutional consensus at the national level, of a clinical history for diagnosis and management of lesions and caries risk. Finally, 55 institutions participated in this consensus, and we have just finished a pilot test of the forms to submit a proposal for national standardization from the MSPS. The aim of this multicentre case series is to assess after 3, 6 and 12 months in children oral health outcomes, caregivers' satisfaction and in dentists' process outcomes, after the implementation of the CCI system adapted for the COVID-19 era -non-aerosol generating procedures. Oral health outcomes will be evaluated in terms of: - Effectiveness of CCI to control bacterial plaque, caries progression and caries risk, and to achieve behavioural change in oral health in children. - Acceptance of CCI caries management adapted for COVID-19 through Treatment Evaluation Interventory in dentists, and in children/parents through satisfaction questionnaire. - Costs of CCI adapted for caries management, in economic terms, number and appointment time.

NCT ID: NCT04509908 Recruiting - Diet Habit Clinical Trials

Eating and Physical Activity Patterns of the Population Working in the Uruguayan State Electrical Company.

PAF
Start date: July 1, 2020
Phase:
Study type: Observational

Stuydy of eatin and physical activity patterns in Uruguayan workers and association with obesity, overweight, and tasks.