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NCT ID: NCT04315662 Not yet recruiting - Muscle Weakness Clinical Trials

Power Training on Muscle Quality and Functional Capacity in Women Aged 65-75.

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

Muscle power training has proven to be an effective intervention to prevent sarcopenia and frailty in old people. In the last decade, new concepts related to the functionality of old people have been generated, such as muscle quality and functional capacity. The power training consists of rapid movements of short duration that imply a more specialized neuromuscular response and that improve the functional response reflected in activities of daily life that demand a certain manifestation of muscular power (stand up of a chair, climbing stairs, rebalance, accelerate suddenly, among others). Therefore, it is important to investigate the dose-response relationships in power training in older people and establish how possible improvements in muscle quality can be reflected in functional capacity. The aim of this study is to compare the effects of power training at two different loads on muscle quality and functional capacity in women aged 65-75

NCT ID: NCT04175860 Not yet recruiting - Clinical trials for Treatment Adherence and Compliance

Adherence to the Transition-discharge-hospital Plan in Patient-family Caregiver With Chronic Pathology

Start date: November 30, 2019
Phase: N/A
Study type: Interventional

To evaluate the therapeutic adherence of the patient-family caregiver with non-communicable chronic disease through the hospital transition-discharge plan program in a second level institution in the metropolitan area of Bucaramanga. Methods: The study will be a randomized controlled clinical trial in 100 participants who meet the inclusion criteria, distributed in a 1: 1 ratio for the intervention group and the control group, considering a confidence level of 90%, power of 80% and a reduction of 30%. Expected results: demonstrate the relevance of the program in the target population through the formation of information mechanisms between the parties involved in direct care, the development of skills and safety at home; the timely identification of the risks inherent to clinical conditions or possible complications associated with care, which aim to reduce the burdens related to the health - disease experience; also emphasize the continuity of the treatment established. On the other hand, achieve a more informed professional performance, prepared, transparent, that responds to the needs and expectations of the user in terms of monitoring and comprehensive therapeutic management. Impact: It is expected that this research will be the basis for the protocolization and implementation of the hospital discharge transition plan program in the health institution and subsequently develop a prospective study on a larger scale, which will allow evaluating its impact on the target population in order to reduce the complications, re-admissions and costs derived from the care of chronic patients.

NCT ID: NCT04070066 Not yet recruiting - Telemedicine Clinical Trials

Educational Strategy IN Exchange Transfusion

INTEXUS
Start date: September 30, 2019
Phase: N/A
Study type: Interventional

Abstract Background: Exchange transfusion is a highly complex procedure that requires high levels of expertise. Paediatricians trainees do not have adequate training because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusions that allow the students to develop competencies to perform the technique in an appropriate and safe way. Methods/design: A randomized parallel single-blind clinical trial with allocation by simple randomization to the educational intervention (simulation or a digital didactic environment). Students from the paediatric specialization who volunteer to participate will be included. A practical evaluation of the procedure will be performed through a simulated scenario using a standardized clinical case. The main outcome is defined as the result of evaluation using the Objective Structured Clinical Examination; superior performance will be defined when the percentage is greater than or equal to 85%, and nonsuperior performance will be defined when the result is less than 84%. The chi-square independence test or the Fisher exact test will be used to evaluate the effect of the interventions. Multivariate analysis will be performed using a non-conditional logistic regression model. Stata 14 ® software will be used. Discussion: Exchange transfusion is a procedure that requires expertise to achieve adequate outcomes. The inclusion of new educational strategies, such as simulation and digital didactic environments, is seen as a training option that can improve performance in clinical skills, reduce adverse events and increase the level of trust.

NCT ID: NCT04011059 Not yet recruiting - Clinical trials for Coronary Artery Disease

Randomized Study of Coronary Revascularization Surgery With Injection of WJ-MSCs and Placement of an Epicardial Extracellular Matrix

scorem-cells
Start date: July 2, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Ischemic heart disease is one of the most important causes of mortality and morbidity in the Western world and is a public health problem. Among ischemic heart diseases, myocardial infarction has specific significance because the cardiac muscle does not have sufficient and adequate capacity to regenerate; therefore, necrosis of a region leads to the formation of a fibrous scar. Infarction can lead to a progressive and irreversible decrease in cardiac function, resulting in heart failure (HF) syndrome, depending on the area affected by this scar, via a ventricular remodeling mechanism. In recent years, HF has been revealed as a major public health problem due to its incidence and its social, economic and especially human impact, as it represents a serious limitation of the quality of life of individuals. The prevalence of HF in the general population of the United States and the United Kingdom is approximately 1%, and in those older than 75 years, the prevalence varies between 5 and 10%. Regarding its prognosis, recent data from the Framingham Study indicate that at 5 years, the mortality rate of HF is 75% in men and 62% in women; the mean mortality rate of all cancers is 50%. The molecular basis of congestive HF is the absence of cardiac cells capable of regenerating the heart muscle. Despite the publication of recent studies suggesting the existence of stem cells capable of regenerating cardiomyocytes destroyed because of myocardial infarction, in humans, the capacity of these cells is insufficient to replace the cells destroyed due to necrosis secondary to ischemia. In recent years, the accumulation of results derived from preclinical studies has allowed the development of the first clinical trials of the feasibility and safety of cardiac regeneration using cellular therapy. Several studies have shown that t cells exist in adult bone marrow, such as mesenchymal stem cells, hematopoietic stem cells and, more recently, multipotent stem cells (MAPC), with the ability to differentiate into endothelial tissue and cardiac muscle, which can contribute to the regeneration of damaged myocardial tissue and improve cardiac function in animal infarction models. However, cell therapy research has moved rapidly toward the use of more undifferentiated cells rather than hematopoietic lineages, such as mesenchymal cells. These cells can be obtained from different sources, with a tendency toward the use of characterized allogeneic cells, which are immediately available in the potential recipient. Given that this type of therapy has not been rigorously investigated in Latin America, we aim to determine the effect of therapy using Wharton's jelly-derived mesenchymal cells (WJ-MSCs) from the human umbilical cord on neomyogenesis in patients with previous myocardial infarction who are undergoing open revascularization. Our hospital has some experience with regenerative therapy, both in patients with acute myocardial infarction and chronic infarction, with encouraging results that support this new phase of inter-institutional research. Objective: To evaluate the safety and estimate the effect of coronary revascularization accompanied by intramyocardial injection of WJ-MSCs and the placement of an extracellular matrix patch seeded with WJ-MSCs compared to coronary revascularization accompanied by injection of culture medium without the presence of WJ-MSC and placement of an extracellular matrix patch without seeding with WJ-MSC on global and regional cardiac function, myocardial viability and the incidence of adverse effects determined as ventricular arrhythmias.

NCT ID: NCT03917134 Not yet recruiting - Hysterectomy Clinical Trials

Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Operative site infection remains the most common complication after performing a gynecological procedure, and has a great implication in the morbidity and mortality of patients. Gynecological procedures, including laparoscopic hysterectomy, represent a unique challenge due to the amount of microorganisms found at the skin level of the vagina or the endocervix. However, there is no clear evidence that the complication decreases with the use of postoperative antibiotics. With the completion of this study, a multicentre triple-blind controlled randomized controlled trial is intended to determine the behavior of the application of this intervention. Patients who attend an outpatient clinic with benign pathology will be selected, in which indication of laparoscopic hysterectomy, consents are completed and research content is widely explained. Prior to surgery, the sample is taken for a gram of vaginal discharge and in the post-surgical phase delivery of the medication will be performed. Follow-up will be carried out by surgical control and by telephone. The investigator intend to find that with the prophylaxis not only of presurgical cephalosporin, but with the formulation of metronidazole ovules in the postoperative, the incidence of laparoscopic post-hysterectomy vaginal abscess and cellulitis of cuff is reduced.

NCT ID: NCT03138486 Not yet recruiting - Clinical trials for Various Advanced Cancer

A Study of the Effectiveness in Patients With Gastric or Gastroesophageal Junction Cancer With Nivolumab by Itself or in Combination With Ipilimumab and in Patients With Esophageal Cancer With Combination of Nivolumab and Ipilimumab.

CheckMate 648
Start date: June 1, 2017
Phase: Phase 2
Study type: Interventional

The main purpose of this study for patients with gastric or gastroesophageal cancer is to evaluate how well the tumor is responding to treatment with nivolumab by itself, or in combination with ipilimumab. For patients with esophageal cancer, the main purpose is to evaluate how well the tumor is responding to treatment with the combination of nivolumab and ipilimumab.

NCT ID: NCT02948491 Not yet recruiting - Premature Birth Clinical Trials

Effectiveness of Music Therapy on the Development of Preterm Neonates

EMT-DRNP
Start date: June 2017
Phase: N/A
Study type: Interventional

Pragmatic, randomized controlled clinical trial with blinding of the evaluator, performed in order to estimate the effectiveness, six (6) months after hospital discharge, of music therapy on the intra-hospital evolution and neurodevelopment of preterm neonates (gestational ages 28 to 37weeks) who are treated in Neonatal Intensive Care Units (NICU) in the Bucaramanga Metropolitan Area.

NCT ID: NCT02299908 Not yet recruiting - Pain, Postoperative Clinical Trials

Ultrasound-guided Transverses Abdominis Plane Block in Inguinal Herniorrhaphy: Randomized Controlled Clinical Trial

Start date: November 2014
Phase: Phase 4
Study type: Interventional

Acute postoperative pain is one of the most important centers of therapeutic attention in postoperative phase of any procedure. It is a complex entity that requires a multiple intervention to be treated and, depending on the intervened surgical site, it has different approaches. Despite attempts to reduce postoperative pain by implementing management protocols, rates of pain prevalence from moderate acute to severe pain are still reported as high as 50% in the first 24 postoperative hours. Among the surgeries that report greater intensity of postoperative pain is open inguinal Herniorrhaphy. That is why several techniques have been described for the management of acute pain in this surgery postoperative, among which PAT blocking has shown to be beneficial in some studies. However, some reports question its usefulness but with the emergence of ultrasound-guided techniques for its realization, interest in this blockage has grown back. This study aims to demonstrate the utility of the PAT blocking in the management of acute pain of pre-peritoneal inguinal herniorrhaphy with mesh.

NCT ID: NCT01917032 Not yet recruiting - Malnutrition Clinical Trials

Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín

Start date: September 2013
Phase: Phase 3
Study type: Interventional

Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable preschool population, to corroborate the reported benefits of the experiences in other countries. Question: Will it improve the nutritional status and hematological levels after the home fortification with Sprinkles in children of two child care centres in the city of Medellin, in 2013? Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators will be better in the intervention group with Sprinkles, compared with the placebo group. Design: Randomized clinical trial, triple-blind and placebo-controlled. Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or with severe malnourished, full-time assistants to two children's centres that have the same alimentation menu. Intervention: The daily diet will be supplemented with sprinkles in one of the children's centres and will be compared anthropometric and hematological values before and after with a group receiving the same diet with placebo. Outcome measures: Nutritional status (anthropometric measures) and haematological values (hemoglobin, ferritin, transferrin and folate).

NCT ID: NCT01734954 Not yet recruiting - Anesthesia Clinical Trials

Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery

Start date: April 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the latency period (timing between the injection of the local anesthetic and the onset of complete sensory nerve block) of two approaches for ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned nerve. Our main hypothesis is that the first approach will decrease the latency period, and probably, will increase the success rate of the nerve block as well as patient satisfaction.