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NCT ID: NCT03680534 Completed - Clinical trials for Root Canal Infection

3D Analysis of Root Canal Conformation

Start date: August 24, 2017
Phase: N/A
Study type: Interventional

Aim To evaluate in vivo the shaping ability of the canal with 3 different single-file systems: Reciproc Blue, WaveOne Gold and XP Endo-Shaper, using cone beam computed tomography and 3D reconstructions to measure canal volume increase, centering ability of the instruments and canal transportation in human premolars in vivo. Methodology Thirty human lower premolars were randomly divided into three groups, in which root canals were prepared using one of these single-file systems: Reciproc Blue, WaveOne Gold, and XP EndoShaper. Root canals were scanned before and after root canal preparation by using CBCT and 3D reconstruction was carried out to evaluate canal volume increase, centering ability of the instrument and canal transportation for each group. Statistical analysis was made for each variable to determine statistically significant differences between groups.

NCT ID: NCT03676608 Recruiting - Breastfeeding Clinical Trials

Use of Bee Wax Mammary Areolae to Improve Breastfeeding

Start date: June 1, 2018
Phase: Phase 3
Study type: Interventional

A comparative randomized intervention study is presented between a mixed strategy of use of bee wax mammary areolae. Together with the health education program for the promotion of breastfeeding by the WHO and another educational program with the aim of improving the adherence of breastfeeding to primiparous women. The use of both interventions can contribute to the adherence to exclusive maternity in 20% in the first 6 months of life, than only with the educational program. The study provides evidence of nursing practice, thus contributing to the improvement of nursing mothers in the prevention of lesions in the nipple and care in them if they occur. Consequently, improve the rates of successful breastfeeding, as well as the quality of life of breastfeeding mothers. The study will be carried out with several groups of midwives in Health Centers, in Spain, Colombia and Mexico. The sample was calculated in 240 women who attend the midwife's controls between week 29 and 40.

NCT ID: NCT03663881 Not yet recruiting - Safety Issues Clinical Trials

Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia

Start date: October 2018
Phase: Phase 1
Study type: Interventional

Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols and has a major antioxidant activity. The extract shows immunomodulatory activity in healthy animals and anti-tumor activity in animals with breast cancer and melanoma as well. The use of P2Et in animals with tumors shows a synergistic effect with doxorubicin in drug-resistant cell lines. In addition, an increase in survival of transplanted animals with a TS/A breast cancer tumor model and treated with P2Et, in conjunction with calreticulin increase is observed. This open-label, single arm, Phase 1 study intends to assess the safety of P2Et extract obtained from Caesalpinia spinosa, with dose escalation, in healthy voluntary participants in Colombia.

NCT ID: NCT03650062 Recruiting - Acute Pancreatitis Clinical Trials

Patient-reported Outcome Scale in Acute Pancreatitis

PAN-PROMISE
Start date: May 30, 2017
Phase:
Study type: Observational [Patient Registry]

The PAN-PROMISE study (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis-an international proSpEctive cohort study) aims to measure an outcome variable in acute pancreatitis (AP) based in the patient´s experience. PAN-PROMISE is a cohort study involving patients with AP. The patient´s symptom perception will be compared with the opinion of the clinicians and with clinical outcomes.

NCT ID: NCT03646227 Enrolling by invitation - Clinical trials for Bacterial Infections

Multi-Drug Resistant Organism Network

MDRO Network
Start date: June 16, 2016
Phase:
Study type: Observational

This study is specifically designed to provide observational data which can be used to help in the design of future randomized clinical trials on both therapeutics and diagnostics for MDRO infections. To this end, clinical and epidemiological data will be collected on patients who have MDRO isolated from clinical cultures during hospitalization, as well as descriptions of the outcomes of patients treated with various antimicrobial regimens. Molecular and microbiological characterization will also be performed on MDRO isolates. These data will include a detailed clinical and epidemiological description of patients including identifying potential barriers to enrollment in future trials. In addition, data will be collected on species, strain type, and mechanism of drug resistance of the causative organism. Knowing the molecular characteristics will further inform future trial design as not all diagnostics detect and not all therapeutics are active against the same mechanisms of resistance.

NCT ID: NCT03643536 Completed - Quality of Life Clinical Trials

12-week Exercise-based Program in Myocardial Revascularization Subjects

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

To determine if a 12-week physical exercise program (12-WPEP), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) with different left ventricular ejection fraction (LVEF) might improve the health-related quality of life (HRQOL).

NCT ID: NCT03634371 Active, not recruiting - Healthy Clinical Trials

Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg

Start date: August 10, 2018
Phase: Phase 4
Study type: Interventional

The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.

NCT ID: NCT03631719 Recruiting - Wolbachia Clinical Trials

Wolbachia Disease Impact in Medellin and Bello

WMP-COL
Start date: October 25, 2017
Phase:
Study type: Observational [Patient Registry]

Study setting: Medellin and Bello municipalities, Colombia Health condition(s) studied: Dengue, Zika and chikungunya virus infection Intervention: Deployment of Wolbachia-infected Aedes aegypti mosquitoes in Medellin and Bello, in addition to standard practice dengue control activities. Primary endpoints and analysis: Strategy 1. Measurement of incidence rate ratio of dengue cases before and after Wolbachia deployment as measured by the public health surveillance system in Medellin and Bello. Strategy 2. Estimate of the odds of symptomatic, virologically-confirmed dengue virus (DENV) infection of any severity in the case-control study area in Medellin. The intention-to-treat analysis will consider Wolbachia exposure as binary depending on the location of the study participants' residence in the period 3-10 days prior to study enrolment.

NCT ID: NCT03615118 Recruiting - Depression Clinical Trials

AniMovil mHealth Support for Depression Management in a Low-Income Country

AniMovil
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Depression is a huge public health problem in low and middle-income countries (LMICs). Mental health care systems in most LMICs are extremely limited, impeding the dissemination of WHO-recommended models for improving care via "task-shifting" services to community health workers (CHWs) who deliver evidence-based treatments such as cognitive behavioral therapy (CBT). This comprehensive intervention will use IVR and text messaging (SMS) to support effective depression care. Intervention patients will receive weekly automated (IVR) calls and daily text messages (SMS) throughout the 12 week intervention. Patients with more severe depression will receive up to 12 weekly CHW-delivered telephone CBT sessions, based on WHO recommendations and a treatment model developed and tested in India. CHWs will use patients' IVR contacts to enhance psychoeducation and they will use SMS plus web-based reports based on patients' IVR calls to identify individuals needing additional follow-up. The CHWs' clinical supervisor will use SMS messages to CHWs to reinforce best practices and monitor service delivery. Patients will be enrolled from Colombian clinics associated with the Universidad de Los Andes in Bogota, Colombia. 114 patients will be randomized to either a usual enhanced care or intervention group. Intervention group patients will receive weekly automated (IVR) calls and daily text messages throughout the duration of the 12 week intervention. Patients with more severe depression will receive up to 12 weekly CHW-delivered telephone CBT sessions, based on WHO recommendations and a treatment model developed and tested in India. CHWs will use patients' IVR contacts to enhance psychoeducation and they will use SMS plus web-based reports based on patients' IVR calls to identify individuals needing additional follow-up. The CHWs' clinical supervisor will use SMS messages to CHWs to reinforce best practices and monitor service delivery. Program components will be modified to fit the local culture and clinical environment via iterative engagement of health professionals and patients with depression. Those patients in usual enhanced care will receive the study manual and daily text messages and feedback throughout the duration of the program. Patients in the enhanced usual care group who present with more severe depression will be referred to the national program office for depression services support - a free service available to all citizens diagnosed with depression.

NCT ID: NCT03613103 Not yet recruiting - Clinical trials for Airway Complication of Anesthesia

Airway Injuries After Intubation Using Videolaryngoscopy Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation

Start date: August 2018
Phase: N/A
Study type: Interventional

Abstract Background Successful tracheal intubation during general anesthesia requires a direct laryngoscope to retract the tongue and soft tissues of the mouth to achieve a line of sight for the larynx. Generally, Macintosh blade laryngoscopy is used to achieve the tracheal intubation. However, difficulties with the tracheal intubation arise the need to use alternative laryngoscopes that use digital or fiberoptic technology, to improve the larynx visibility. Among these devices, highly curved blade videolaryngoscope uses a curved blade to retract the soft tissues of floor of the mouth and transmits a video image to a screen, achieving better larynx visibility. Also, the decrease of the force in the soft tissues with videolaryngoscope could reduce airway injures. Objectives Our primary objective is to assess whether use of videolaryngoscopy using highly curved blades for tracheal intubation in adults requiring general anesthesia reduces risk of airways injuries compared with Macintosh direct laryngoscopy. Our secondary aim is to assess postoperative satisfaction of the patients, successful intubation at the first attempt, successful global intubation, degree of larynx visibility according to classification Cormack - Lehane and time taken to perform intubation in videolaryngoscopy vs direct laryngoscopy. Finally, we assess the risk of presenting serious adverse event with the use of videolaryngoscopy compared with Macintosh laryngoscopy in hypoxemia, bradycardia and heart arrest.