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NCT ID: NCT04667728 Completed - Clinical trials for Diabetes Mellitus, Type 2

Professional Continuous Glucose Monitoring as an Adjuvant Educational Tool for Improving Glycemic Control in Patients With Type 2 Diabetes.

Start date: May 30, 2017
Phase: N/A
Study type: Interventional

The investigators conducted a three-month quasi-experimental study with an intervention and control group and ex-ante and ex-post evaluations in one family medicine clinic in Mexico City. Participants were type 2 diabetes patients with HbA1c>8 mg/dL attending a comprehensive diabetes care program (MIDE). In addition to the program, the intervention group wore a professional CGM sensor (iPro™2) during the first six days of the study. Following this period, intervention group participants had a medical consultation for the CGM results and treatment adjustments. Additionally, the intervention group participants received an educational session and a personalized diet plan from a dietitian. After three months, the intervention group again wore the CGM sensor for one week. The primary outcome variable was HbA1c level measured at baseline and three months after the CGM intervention. The investigators analyzed the effect of the intervention on HbA1c levels by estimating the differences-in-differences treatment effect. Additionally, baseline and three-month CGM and dietary information was recorded for the intervention group and analyzed using the Student's paired t-test and mixed-effects generalized linear models to control for patients' baseline characteristics.

NCT ID: NCT04666597 Completed - Clinical trials for Dental Caries in Children

Pandemic-adapted Caries Care Multicentre Single-group Interventional Study

Start date: November 15, 2020
Phase:
Study type: Observational

The current understanding of dental caries has not been completely transferred into the clinical practice to control caries lesion progression (severity / activity) and the individual risk of caries. This situation led to the development of the CariesCare International CCI Caries Management System (2018), derived from ICCMS™- International Caries Classification and Management System (2012) and the ICDAS - International Caries Detection and Assessment System (2002) in a consensus among more than 45 cariologists, epidemiologists, public health professionals, researchers and cliniciansfrom all over the world. The consensus aimed to guide dentists and dental teams in clinical practice, facilitating the control of the caries process and the maintenance of oral health in their patients. The general lack of implementation of an updated management of dental caries is evident in Colombia, in the survey of 1094 clinicians, teachers and students, failures were reported to adopt related behaviours, motivation barriers (remuneration), opportunity (in terms of relevance, physical/infrastructure resources, time) and training. As an additional barrier, the Colombian Chapter of the Alliance for a Cavity-Free Future (ACFF), evidences the absence of a facilitating Oral Health Record (OHR), this situation lead to stablish a new Alliance between the Ministry of Health and Social Protection (MSPS) and the AFLC to develop an inter-institutional consensus at the national level, of a clinical history for diagnosis and management of lesions and caries risk. Finally, 55 institutions participated in this consensus, and we have just finished a pilot test of the forms to submit a proposal for national standardization from the MSPS. The aim of this multicentre case series is to assess after 3, 6 and 12 months in children oral health outcomes, caregivers' satisfaction and in dentists' process outcomes, after the implementation of the CCI system adapted for the COVID-19 era -non-aerosol generating procedures. Oral health outcomes will be evaluated in terms of: - Effectiveness of CCI to control bacterial plaque, caries progression and caries risk, and to achieve behavioural change in oral health in children. - Acceptance of CCI caries management adapted for COVID-19 through Treatment Evaluation Interventory in dentists, and in children/parents through satisfaction questionnaire. - Costs of CCI adapted for caries management, in economic terms, number and appointment time.

NCT ID: NCT04661969 Completed - Surgery Clinical Trials

"Outcomes of Surgical Removal of Foreign Body Granulomas"

Start date: January 2014
Phase:
Study type: Observational

Illicit subcutaneous injection of high-viscosity fluids for restoration and improvement of body contour is a growing trend all around the world. Many local and systemic complications have been described. Local complications include deformity at the site of injection, granulomas and several skin changes like erythema, induration, and plaques (well-circumscribed, elevated, superficial, solid lesion). The investigator designed a single-center, cross-sectional, retrospective, consecutive case series study and evaluated 49 surgeries performed in 35 patients with the history of foreign substances injection for cosmetic purposes and developed local complications. Investigators divided 4 groups accordingly to localization of foreign substances (FS). Group 1) FS disseminated to both lower extremities and buttocks; group 2) FS isolated to buttocks with moderate to severe skin changes, Group 3) FS isolated to lower legs with mild skin changes and superficial ulcerations and 4) FS isolated to lower legs with moderate to severe skin changes and/or ulceration. The investigators treated all patients surgically, which consisted of isolate ultrasonic liposuction for extraction of the material from the affected region (group 1) In-bloc excision and primary closure (group 2), Resection plus Vacuum assisted closure (VAC) and split thickness skin graft (STSG) (group 3) and In-bloc excision and microsurgical reconstruction (group 4). Statistical analysis was performed to find relations between type of surgery with complications, reactivation of symptoms, time for reactivation and a disease-free survival test (kaplan meier) was done.

NCT ID: NCT04652102 Completed - Covid19 Clinical Trials

A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older

Start date: December 11, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants.

NCT ID: NCT04648085 Completed - Dry Eye Clinical Trials

Effect of Trigeminal Nerve Stimulation on Corneal Nerves and Chronic Ocular Pain

Start date: February 3, 2021
Phase: N/A
Study type: Interventional

Individuals with dry eye tend to present with ocular pain which persists despite the use of topical treatment. This could be secondary to somatosensory impairment attributable to neuropathic pain. The purpose of this study is to evaluate the effect of trigeminal nerve stimulation (TNS) on corneal nerves and chronic ocular pain in patients with dry eye.

NCT ID: NCT04646733 Completed - Weight Loss Clinical Trials

Effect of a Low-carbohydrate, High-protein Energy-restricted Diet on Weight and Body Composition Using DXA

Start date: January 13, 2020
Phase: N/A
Study type: Interventional

People often choose certain diets to lose weight or to change their habits or lifestyle. The Dukan diet was created in the '70s and took on importance in the last decade. It is a 4 phase diet similar to the Atkins diet. However, this diet is aggressive in its first phase because it suppresses carbohydrates, the main source of external energy being saturated low-fat protein. Studies of this diet are scarce and have been limited to describing the contribution of micronutrients. In nutritional practice, it is often assumed that a popular high-protein or low-calorie ketogenic diet could cause rapid or unfavourable changes in a patient's weight and body composition. However, the effect of these diets in the short or long term on weight and on body fat, muscle mass and other components is not clear. This means that body composition has not been the main objective when analyzing the effect of a popular diet. For this reason, the meta-analyzes focus on weight change and the absence of body composition data is a limitation of the selected studies. Changes in body composition due to a popular diet should be evaluated with techniques such as DXA. The aim of this study is to analyze the effect of a low-carbohydrate, high-protein diet with energy restriction on weight and body composition using DXA. For this, a randomized controlled study will be used where a group will receive the diet protocol. The control group will have a normal diet, and only one oatmeal drink will be added (55 g of oats in 250 ml of water). The drink will contain 1.6 g of BetaG per serving according to FDA recommendations that correspond to the 50% BetaG required per day.

NCT ID: NCT04645979 Completed - Rhinitis, Allergic Clinical Trials

A Study to Learn What Participants Think of Treatment With Betamethasone Plus Loratadine to Treat Their Acute Allergic Rhinitis, Also Known as Hay Fever in Mexico

Start date: November 11, 2020
Phase:
Study type: Observational

Acute allergic rhinitis is a common allergic reaction to things like pollen or dust. It causes inflammation inside the nose, resulting in symptoms similar to the common cold. Allergic rhinitis is also known as hay fever. In this study, the researchers want to learn what participants think of betamethasone plus loratadine as a treatment for their acute allergic rhinitis. These participants will have used betamethasone plus loratadine as a treatment for their acute allergic rhinitis within the past two months. During the study, participants will complete an online questionnaire about their experience with betamethasone plus loratadine.

NCT ID: NCT04645745 Completed - Clinical trials for Polycystic Ovary Syndrome

Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS

Start date: June 15, 2019
Phase: N/A
Study type: Interventional

The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of women, belonging to the Mexican and Italian population, both affected by Polycystic Ovary Syndrome.

NCT ID: NCT04640194 Completed - Clinical trials for Acute Respiratory Distress Syndrome

A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19

TRISTARDS
Start date: December 16, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster. The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment. Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month. Participants are in the study for 3 months.

NCT ID: NCT04640168 Completed - COVID-19 Clinical Trials

Adaptive COVID-19 Treatment Trial 4 (ACTT-4)

Start date: December 2, 2020
Phase: Phase 3
Study type: Interventional

ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.