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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 Completed - 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.

NCT ID: NCT04352634 Recruiting - Depression Clinical Trials

The Covid-19 HEalth caRe wOrkErS (HEROES) Study

HEROES
Start date: April 26, 2020
Phase:
Study type: Observational

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.

NCT ID: NCT04329247 Not yet recruiting - Clinical trials for Carpal Tunnel Syndrome

Physical Therapy in the Treatment of Carpal Tunnel Syndrome

Start date: May 2020
Phase: N/A
Study type: Interventional

In the present investigation the pain reduction effects of a physical therapy technique will be compared to those produced by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

NCT ID: NCT04328805 Not yet recruiting - Clinical trials for Carpal Tunnel Syndrome

Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.

Start date: September 2020
Phase: Phase 4
Study type: Interventional

In the present investigation the pain reduction effect of an oral ibuprofen treatment will be compared to those produced by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

NCT ID: NCT04285281 Not yet recruiting - Clinical trials for Carpal Tunnel Syndrome

Oral Gabapentin in the Treatment of Carpal Tunnel Syndrome

Start date: March 2020
Phase: Phase 4
Study type: Interventional

In the present investigation the pain reduction effects of Gabapentin will be compared to those produced by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.