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NCT ID: NCT05377619 Completed - Dyspepsia Clinical Trials

Preventing Gastric Glitch With Prucalopride and Buspirone: N-of-1 Clinical Trial

Start date: January 6, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Gastric glitch is a new functional disease characterized by severe and transient epigastric pain occurring after challenges such as drinking alcohol and eating specific foods. Aims: In this N-of-1 trial, we first characterized the clinical and gastric tomographic images of a patient with gastric glitch highly reproducible after alcohol challenging, and then tested the effect of prucalopride and buspirone on the prevention of gastric glitch crises.

NCT ID: NCT05370573 Completed - Meningitis Clinical Trials

Brazil ICU Encephalitis Surveillance

Start date: June 1, 2019
Phase:
Study type: Observational

Our proposal is to develop a sentinel syndromic surveillance strategy to identify encephalitis cases possibly related to emerging pathogens admitted to ICUs in Brazil. "Sentinel" to allow a diagnostic intensive approach on a smaller number of cases, "syndromic" to guarantee a sensitive criterion to include new or unexpected pathogens, and in ICUs to prioritize potentially severe threats. In a resource-limited setting it won't be possible to monitor and investigate all cases of encephalitis, so a cost-effective algorithm for early identification of the cases that are most likely to be caused by unusual, unexpected or emerging pathogens must be developed. As universal surveillance of encephalitis is not recommended in Brazil, data on incidence, causes and prognosis is not available, leaving a gap in the understanding of the epidemiology of this central nervous system disease in the country. This study will review cases of encephalitis admitted in the last five years to ICUs in a large metropolitan area. Its results will help understand the epidemiology of encephalitis in Brazil and will provide data to build a strategy for early identification of outbreaks and of emerging infectious diseases.

NCT ID: NCT05363696 Completed - Clinical trials for Cardiac Surgical Procedures

The REPLICCAR Registry and The Statewide Quality Improvement Initiative

REPLICCAR
Start date: August 1, 2013
Phase:
Study type: Observational [Patient Registry]

Cardiovascular diseases remain the leading cause of death for the healthcare system and cardiac surgery has an important impact on their resolubility. Healthcare systems in the world have evolved to optimize their clinical records and thus learn from the real world through the interactivity between results, processes, and structure. When the rate of growth of healthcare costs scenario is greater than the one of Gross Domestic Product of countries, there is a considerable challenge to increment the quality of healthcare services and the primordial patient safety, as well as the necessary control and traceability of implantable devices. The association and correlation of patients' demographic and clinically relevant information with the resources required for the care provided for each stratum represent the possibility to adapt, improve and innovate the healthcare programs; This will allow improving the optimization of the therapeutic protocols and the creation of related research areas, aiming to promote more equitable resources allocation, increase access and effectiveness, as well as to ascertain the magnitude of available and used resources and its impact.

NCT ID: NCT05362071 Completed - Clinical trials for Diabetes Mellitus, Type 2

Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes

RED
Start date: May 2, 2022
Phase: N/A
Study type: Interventional

The present study, characterized as a randomized clinical trial, aims to verify the effects of a remotely supervised exercise program, compared to a control group, on cardiometabolic, functional, and psychosocial outcomes in individuals with type 2 diabetes (DMT2). Males and females with T2DM from the city of Pelotas/RS who meet the study eligibility criteria will participate in the study. Participants will be randomized into the intervention group (IG) and control group (CG). The IG will perform a 12-week exercise program supervised remotely via video call, while GC will receive recommendations for physical activity. Participants will be evaluated at baseline (week 0) and after intervention (week 13). Initially, data for sample characterization, blood pressure, capillary blood glucose, and functional tests will collect during a home visit. In a second moment, participants will be invited to go to a specific laboratory for collecting glycated hemoglobin (HbA1c). Subsequently, a third date will be scheduled to apply self-administered questionnaires (online via GoogleDocs) related to the quality of life, sleep quality, depressive symptoms, emotional stress related to diabetes, level of physical activity, and eating habits. Additionally, acute glycemic responses will be evaluated before and immediately after an exercise session three times throughout the intervention. Capillary blood glucose will be collected in sessions performed in the initial period of mesocycles 1, 2, and 4. At week 13, reassessment will be realized by the same baseline assessors. Over the 12 weeks, a combined training will be carried out with remote supervision. Participants will perform strength exercises at usual and maximum execution speed and aerobic exercises at a rating of perceived effort between 11 and 15 on Borg's scale. The sessions will have a total duration between 37 and 57 min and a weekly frequency of two weekly sessions in the first six weeks and three weekly sessions in the remaining six weeks. Data will be expressed as mean and standard deviation. Data analysis between pre-and post-intervention moments, as well as between groups, will be performed by Generalized Estimated Equations, with Bonferroni post hoc, considering both per-protocol (including participants who meet 70% of frequency in the intervention) and intention to treat analysis (including all randomized participants), assuming an alpha level of 5%.

NCT ID: NCT05362058 Completed - Diabetes Clinical Trials

A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

QWINT-2
Start date: June 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.

NCT ID: NCT05354193 Completed - Clinical trials for Cardiovascular Diseases

Analysis of miRNAs Expression in Vasoplegic Syndrome After On-pump Coronary Artery Bypass Surgery

PREVENT
Start date: August 28, 2017
Phase:
Study type: Observational

This study looks for a correlation between microRNAs (miRNAs) and vasoplegic syndrome after on-pump coronary artery bypass surgery.

NCT ID: NCT05344222 Completed - Clinical trials for Impacted Third Molar Tooth

Effects of Photobiomodulation Conditioning in Impacted Third Molars

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

The removal of third molars should be considered to avoid problems such as cysts and other complications. Surgical intervention with the manipulation of oral tissues has the undesirable postoperative effects of pain, trismus (limited mouth opening) and edema. Photobiomodulation has also proved effective regarding reductions in pain, edema and trismus. The aim of the present study was to evaluate the effectiveness of photobiomodulation for the conditioning of tissues involved in the surgical removal of impacted mandibular third molars in terms of reducing or eliminating postoperative pain, trismus and edema.

NCT ID: NCT05343871 Completed - COVID-19 Clinical Trials

Immunogenicity and Safety of Fractional Booster Dose of COVID-19 Vaccines Available for Use in Pakistan/Brazil: A Phase 4 Dose-optimizing Trial

Start date: July 5, 2022
Phase: Phase 4
Study type: Interventional

Since the emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogen in late 2019, millions of people around the world have fallen ill and died from coronavirus disease 2019 (COVID-19), with variant-fueled case spikes causing repeated cycles of morbidity and mortality. The rapid development and emergency use authorization of vaccines against SARS-CoV-2 presents an enormous opportunity to protect populations, but bottlenecks in production have led to demand for vaccines that far outpaces supply. This project will investigate the immunogenicity of fractional doses of SARS-CoV-2 vaccines given a minimum of six months following an initial two-dose schedule or following natural immunity via documented infection. The consortium of research partners from the Sabin Vaccine Institute, Aga Khan University, Fundação Oswaldo Cruz (Fiocruz), and Stanford University will recruit volunteers to receive a full or fractional booster dose of BNT162b2, AZD1222 or Sinovac following receipt of their primary vaccination series or PCR-confirmed natural infection in Pakistan. The research team will follow participants for six months from boosting, with blood draws at baseline, 28 days, 3 months and 6 months, and measure sero-response rate (SRR) by anti-Spike immunoglobulin G (IgG) binding enzyme-linked immunosorbent assay (ELISA) with the ultimate aim of identifying whether fractional doses provide a similar immune response compared to full doses of vaccine.

NCT ID: NCT05343078 Completed - Clinical trials for End-stage Renal Disease

Pharmacokinetics and Dialyzability of Dapagliflozin in Dialysis Patients

DARE-ESKD 1
Start date: April 25, 2022
Phase: Phase 4
Study type: Interventional

Sodium-glucose co-transporter 2 inhibitors (Sglt2i) attenuate the incidence of cardiovascular events in individuals with preserved or mildly reduced kidney function. Whether this benefit is also observed among individuals with end-stage renal disease (ESRD), in whom cardiovascular disease is a leading cause of mortality, remains unexplored. To appraise the influence of dialysis on the pharmacokinetics of Sglt2i is a prerequisite to determining the treatment regimen that best fits this population. In this study ESRD individuals, aged 18 years and older, on a regular dialysis regimen for a minimum of 3 months at the Nephrology Division of the Clinics Hospital of the University of Campinas (Unicamp) will be enrolled in a pharmacokinetics study. In the single-dose protocol, hemodialysis participants will take Dapagliflozin 10mg P.O. immediately before the dialysis session, and blood samples will be collected every 30min during dialysis and again 24h and 48h after termination. The dialysate will be continuously sampled in a tank and aliquots collected for further analysis. In the multiple-dose protocol, both hemodialysis and peritoneal dialysis participants will take Dapagliflozin 10mg P.O. daily in the morning for 7 days. Blood samples will be collected at baseline, and again after 48h and 7 days. The plasma levels of dapagliflozin and its inactive metabolite, D3OG, will be calculated from blood and dialysate samples using liquid chromatography mass spectrometry. The primary outcome is the plasma concentration-time curve of dapagliflozin and its inactive metabolite D3OG during a regular hemodialysis session. Secondary outcomes are: (i) the steady-state plasma concentration of Dapa; (ii) the accumulation ratio of Dapa; (iii) the total mass of Dapa and D3OG extracted by the dialysate; (iv) the dialytic clearance of dapagliflozin.

NCT ID: NCT05336500 Completed - Low Back Pain Clinical Trials

Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates

Start date: June 6, 2022
Phase: N/A
Study type: Interventional

This study aims to investigate the effectiveness of education to keep the abdomen relaxed versus contracted during Pilates exercises in patients with primary chronic low back pain. Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks. The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way. Primary outcomes will be pain intensity and disability 12 weeks post randomisation.