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NCT ID: NCT04628390 Not yet recruiting - Malocclusion Clinical Trials

Laser Therapy on Controlling Pain During Orthondontic Treatment

Start date: November 20, 2020
Phase: N/A
Study type: Interventional

To evaluate the effectiveness of pain reduction on a initial orthodontic treatment by using 810nm Diode laser compared to a placebo. Methods: This study will include two parallels groups, 30 adult patients each (mean age 18 - 40) that will be asked to fill a questionnaire related with pain before starting orthodontic treatment with Tip edge technique. Patients from one of the groups will receive laser therapy on both upper and lower maxillary according to the protocol. The patients from the other group will receive a placebo simulating a laser therapy on both maxillary. After the process, both groups will be checked on different times (12hrs-24hrs-48hrs-72hrs after) by filling a questionnaire related with pain each time.

NCT ID: NCT04607343 Not yet recruiting - Clinical trials for Obstructive Sleep Apnoea

Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea

Start date: January 2021
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate in a clinical trial a rehabilitation device for patients with obstructive sleep apnoea (OSA) based on oropharyngeal electrical stimulation, which strengthens the dilating muscles of the upper airway, improves mechanical laryngopharyngeal sensitivity and improves OSA. Furthermore, to perform experimental electrotherapy, nasoendoscopy, polygraphy and polysomnography tests with the device in order to calculate thresholds of functional and sensory intensities on the dilating muscles of the upper airway in patients with OSA. These tests also include the detection of signals that measure breathing events during sleep in patients with OSA in order to use them in the control mechanisms of the electrostimulation device. Assess the effects and safety of the device in a group of five healthy volunteers for preliminary results. Finally, to evaluate in a small group of patients with OSA the device capacity to stimulate the upper-airway dilating muscles and to reduce the Apnea-Hypopnea Index (AHI) and oxygen desaturation indices when the electrostimulation device is used over a medium-term period (eight weeks) with morning and evening therapy sessions.

NCT ID: NCT04563364 Not yet recruiting - Premature Birth Clinical Trials

Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children

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

Motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. In Colombia, one out of every five births corresponds to premature babies. In preterm infants requiring hospitalization, early clinical interventions focused on home care have been shown to improve motor development and decrease morbidity. However, interdisciplinary work, supported by information and communication Technologies (ICT), shows a knowledge gap that can be explored. This leads to the following research question: What is the effect of the Interdisciplinary Hospital-Home Intervention on the adaptation of the motor development of premature children compared to traditional intervention in Colombia and Polonia? Objective: To determine the effect of the interdisciplinary Hospital-Home intervention on the adaptation of the motor development of premature children compared to traditional intervention in Colombia and Polonia Methodology Experimental quantitative study with pre-test and post-test to two groups, experimental and control, which compares before and after the intervention. The intervention will be developed in two scenarios: the hospital and the home. The experimental group will receive the intervention and the control group the traditional care established in the institutions for premature children. The calculation of the sample size is 130 participants. Type of results expected to be obtained It is expected to obtain a supported that justifies the importance of education from hospital stay, post discharge follow-up and parental participation in the adequate stimulation of motor development of the premature. It is expected to incorporate the use of ICT in home monitoring, while implementing the use of a mobile application for this purpose. It is also expected to contribute to the research training of undergraduate and graduate students. In addition, participate in national and international presentations and in the production of scientific articles.

NCT ID: NCT04527211 Not yet recruiting - Covid19 Clinical Trials

Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel

IveprofCovid19
Start date: September 7, 2020
Phase: Phase 3
Study type: Interventional

It will be performed a randomized, multicenter, triple-masked, placebo-controlled clinical experiment to determine the effectiveness and safety of the administration to of ivermectin at a dose of 200 mcg/kg once a week for 7 weeks in a prophylactic treatment against SARS COV-2 infection in 550 Colombian health workers during the COVID-19 pandemic.

NCT ID: NCT04480632 Not yet recruiting - COVID-19 Clinical Trials

Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis

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

Introduction: The SARS-CoV-2 outbreak has left more than two million infected worldwide in the first four months of COVID-19 epidemic. To date, there is no specific treatment for the disease and in critically ill patients there is an additional challenge in controlling the systemic inflammatory response, which is characterized by cytokine storm, alteration in coagulation and endothelial activation in addition to infection. Strategies used in previous viral epidemics, such as convalescent plasma, are therapeutic options to rescue, especially in individuals with a critical presentation of the disease. Aim: To establish clinical response of critically ill patients with COVID-19 who received convalescent plasma from subjects recovered from SARS-CoV-2 during their stay in Intensive Care Unit at Fundación Cardiovascular de Colombia (Hospital Internacional de Colombia). Methodology: Quasi-experimental study (no randomization will be performed). Adult patients who meet selection criteria will receive 500 ml of ABO compatible convalescent plasma, obtained by apheresis from patients recovered from SARS-CoV-2 infection. The main outcome will be in-hospital mortality at 30 days, while indication for ventilatory support (intubation) and adverse events at thirty days will be evaluated as secondary outcomes, compared to subjects receiving usual treatment for clinical sign and symptoms given the absence of ABO compatible plasma units. A survival analysis will be performed using Kaplan-Meier method and association strength will be reported using HR and 95% CI crude and adjusted for confounding variables. Expected results: It is expected to know the clinical and paraclinical response of patients receiving convalescent plasma in our institution, as well as to establish their probability of survival and its associated factors.

NCT ID: NCT04425837 Not yet recruiting - Covid-19 Clinical Trials

Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19

Start date: July 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.

NCT ID: NCT04395170 Not yet recruiting - Clinical trials for Coronavirus Disease 2019 (COVID-19)

Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

Start date: September 2020
Phase: Phase 2/Phase 3
Study type: Interventional

A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia.

NCT ID: NCT04391101 Not yet recruiting - SARS-Cov-2 Clinical Trials

Convalescent Plasma for the Treatment of Severe SARS-CoV-2 (COVID-19)

Start date: June 2020
Phase: Phase 3
Study type: Interventional

Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. The hypothesis is that convalescent plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in ICU

NCT ID: NCT04385186 Not yet recruiting - Clinical trials for Infections, Coronavirus

Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19

Start date: June 20, 2020
Phase: Phase 2
Study type: Interventional

Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.

NCT ID: NCT04384237 Not yet recruiting - Rotated Teeth Clinical Trials

Er,Cr:YSGG Laser-aided Fiberotomy in the Prevention of the Lower Incisors Rotational Relapse

laser
Start date: March 2021
Phase: N/A
Study type: Interventional

To establish the effect of erbium, chromium,yttrium,scandium,gallium and garnet (Er,Cr: YSGG) laser-aided circumferential supracrestal fiberotomy compared to a conventional circumferential supracrestal fiberotomy group, after leveling and alignment during the first month after arch wire removal on the prevention of rotational relapse in lower incisors. Methods: Randomized clinical trial in 60 orthodontic patients with two to four lower incisors rotation between 30º-50º degrees before treatment.They are going to be assigned in two intervention groups, each group with 30 patients. One group are going to be treated with Er;Cr: YSGG laser -aided CSF and the other group with conventional circumferential supracrestal fiberotomy. After leveling and alignment each procedure will be performed and after one month healing the arch wire will be removed for a month and lower incisor relapse will be measured through cast models in a software. Periodontal parameters will be registered before and after procedures.The outcomes are going to be determined and compared between groups with corresponding statistical test and results will be analyzed