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NCT ID: NCT05543759 Recruiting - Child Malnutrition Clinical Trials

Simplified Treatment Protocol for Acute Malnutrition in Venezuela

Start date: September 5, 2022
Phase:
Study type: Observational [Patient Registry]

Global acute malnutrition (GAM) in children under five is defined by being too thin for a given height and/or having the Mid-upper arm circumference less than a given threshold. GAM includes moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). This study has been designed to generate new evidence about the simplified combined protocol for the identification and treatment of GAM in Venezuela. The objective of the study is to document the safety and effectiveness of the Venezuelan simplified treatment protocol for GAM, which includes reduced frequency of follow-up visits, single product use and optimized daily RUTF dose. This prospective longitudinal study was conducted in 19 centers treating GAM in children aged 6-59 months diagnosed with uncomplicated GAM, defined as WHZ <-2 or MUAC <125mm or ++ bilateral edema. Children will be prospectively followed for a total of 6 months, including the treatment phase and the immediate post-discharge weeks until 6 months. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment and changes in anthropometry (weight, height and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.

NCT ID: NCT05445089 Completed - COVID-19 Clinical Trials

Study to Verify the Effectiveness and Safety of Isothymol or Carvacrol Compound Against SARS-CoV-2 in COVID-19 Patients

Start date: August 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

• Check the efficacy, safety and tolerability of the compound Modified isothymol against the SARS-CoV-2 agent in patients COVID-19.

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: NCT04945304 Recruiting - Clinical trials for Bariatric Surgery Candidate

9-Step Magnetic Bariatric Revisional Surgery

Start date: May 31, 2021
Phase:
Study type: Observational

RYGB represents one of the best alternatives for weight loss in obese patients achieving a weight loss of up to 60% and a resolution of comorbidities of 70%. Revision surgery contemplates multiple techniques including the conversion from one surgical technique to another, structural changes to the primary technique, among others. GERD is now a long-term problem for patients who have undergone LGS. RYGB is one of the best techniques to resolve this problem.

NCT ID: NCT04944810 Recruiting - Surgery Clinical Trials

Magnetic System in Bariatric and General Surgery

Start date: June 10, 2021
Phase:
Study type: Observational

Magnetic devices have been successfully used in bariatric surgery. To the date the only reported use of the magnet was for liver retraction. This study is to demonstrate the safety and viability of using the magnetic system as a second surgical assistant in bariatric surgery and not only for liver retraction.

NCT ID: NCT04931706 Recruiting - Obesity Clinical Trials

Nissen Sleeve by Single Port With Magnetic Assistance

Start date: June 5, 2021
Phase:
Study type: Observational [Patient Registry]

New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system

NCT ID: NCT04927871 Completed - Obesity Clinical Trials

Hybridized Three Steps Intervention to Prevent Diabetes in Venezuela

HITS
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

The American Diabetes Association recommends implementing the Diabetes Prevention Program (DPP) in subjects with prediabetes. In the DPP, weight reduction was the main predictor of a lower incidence of type 2 diabetes (T2D), each kilogram lost was related with 16% lower incidence. However, the effectiveness of the DPP in primary care settings is lower than the original study. A meta-analysis of 36 pragmatic clinical trials of DPP in primary care settings showed a reduction in T2D incidence by 26%, less than half than the original study (58%), with a pooled mean weight loss 1.57 kg higher than standard care, demonstrating the large difficulties to reduce weight of participants at community levels. Total diet replacement (TDR) with low-energy liquid-diet or solid diet (825-853 kcal/day) is an effective strategy to reduce weight. The effectiveness of an intervention including initial rapid weight loss before starting the DPP is ignored in primary care levels in Venezuela. We aim: 1- To compare the weight loss achieved of two lifestyle intervention programs in a community health center of Venezuela: a) A hybrid lifestyle including rapid weight loss with total diet replacement (TDR), then medical nutrition therapy (MNT), and the DPP, VS b) only the DPP; 2- To evaluate the change of cardiometabolic risk factors between groups; 3- To evaluate the implementation process. Our hypothesis is: after six months of intervention, subjects receiving a hybridized lifestyle (TDR+MNT+DPP) will double the weight loss of those that only receive DPP.

NCT ID: NCT04884230 Completed - Obesity Clinical Trials

Oversewing Staple Line of The Gastric Remnant

Start date: February 5, 2017
Phase:
Study type: Observational [Patient Registry]

Background: Roux-en-Y gastric bypass (RYGB) is a surgery with low rate complications. However, it is not exempt from them, and 1-6% suffer complications such as postoperative bleeding. Many intraoperative techniques have been evaluated to reduce postoperative bleeding, like the oversewing or reinforcement of the staple line. This study aims to evaluate the rate of postoperative bleeding in the oversewing of the staple line of the gastric remnant group versus the stapling only group. Methods: This is a 2-center, case-control study. The investigators randomly selected two groups who underwent RYGB or OAGB: group A (n=225) with oversewing from 2019-2020 and group B (n=225) with stapling only between the period of 2017-2018; both groups with similar demographic characteristics.

NCT ID: NCT04585308 Recruiting - Aortic Stenosis Clinical Trials

transShield Embolic Protection System Feasibility Study

Start date: December 15, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).

NCT ID: NCT04545307 Completed - Clinical trials for Apical Periodontitis

Transplantation of Allogeneic MSC in Patients With Pulp Necrosis and Chronic Apical Periodontitis

MSC
Start date: November 27, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of Mesenchymal Stromal Cell (MSC) implantation on pulp and periapical regeneration of immature teeth with pulp necrosis and chronic apical periodontitis. BACKGROUND: - Post-traumatic pulp necrosis prevents root development in children and adolescents. - The multipotent ability of MSC to differentiate into bone-forming cells (osteoblasts) and dentin-forming cells (Odontoblast) has allowed the development of protocols to induce dental pulp regeneration in preclinical models and patients with immature teeth with pulpal necrosis. IMPACT: - Worldwide, post-traumatic pulp necrosis in children and adolescents constitutes a health problem in the endodontic area. - Treatment with MSC would provide an effective therapeutic alternative to patients with pulp necrosis and incomplete root formation. - The possible pulp and periapical regeneration of immature teeth induced by MSC would have a huge impact on the treatment of these patients. Eligibility for EMC implant study Age: 6 to 16 years Sex: Male or Female Healthy volunteers accepted: NO. TREATMENT GROUPS: In the present study, the implantation of MSC will be performed in patients with immature teeth with pulpal necrosis with apical periodontitis, who will receive the appropriate endodontic treatment (according to the guidelines of the American Association of Endodontics) and implantation of allogeneic BM-MSC . This group will be compared with the history made in the Postgraduate Endodontics of the Universidad Central de Venezuela (UCV) and with international case series made by revascularization. Clinical follow-up of each patient: 1. Clinical controls (facial evaluation, gingival evaluation, apical palpation, horizontal and vertical percussion, cold and heat sensitivity tests) will be carried out on days 0, 7, 30, 90, 180 and 364. Additionally, a clinical evaluation will be carried out at the two years post-implantation of MSC. 2. Radiological controls will be carried out on days 0, 7, 30, 90, 180 and 364. Additionally, they will be carried out two years post-implantation of MSC. 3. A tomographic evaluation will be performed when was evident periapical repair in a periapical radiograph. To measure root formation, root canal narrowing and verification the periapical repair in 3D.