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NCT ID: NCT06076109 Terminated - COVID-19 Pneumonia Clinical Trials

Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19.

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

Introduction: The disease caused by the new coronavirus (COVID-19) represents a pandemic with significant affectation in our country, generating critical illness in around 5% of the patients who present this disease at an international level, with the requirement of invasive mechanical ventilation being the main cause of admission to intensive care units (UTI). Objective: to evaluate the utility of using the prone position in patients with hypoxemic respiratory failure with COVID-19 who are with non-invasive oxygenation devices to reduce the need for invasive mechanical ventilation and mortality in this population. Material and methods: a controlled and randomized clinical trial will be carried out, which will include patients who come to the institution for medical attention with a confirmed or suspected diagnosis of COVID-19 with a severe presentation, hypoxemic respiratory failure, and non-existent oxygen therapy. invasive with a FiO2 contribution ≥40%. The patients enter 2 follow-up groups: an intervention group in which the prone position maneuver performed by the patient himself will be implemented, and another group where the patients will remain supine with the head of their bed between 30-60º. The demographic and clinical variables of these patients will be described. The primary outcome to be evaluated will be the proportion of patients requiring orotracheal intubation during their hospital stay. The secondary outcomes that will be evaluated will be hospital mortality, development of ARDS, and changes in oxygenation by determining SpO2 and SpO2/FiO2 on admission and at 1, 6, 12, 24, 48, and 72 hours after inclusion in the protocol. , as well as PaO2/FiO2 on admission and at 24 hours; the time interval between inclusion in the protocol and orotracheal intubation, use of non-invasive ventilatory therapies, days of hospital stay, days of stay in intensive care, days free of mechanical ventilation, development of acute organ failure during hospitalization and complications related to the treatment with the prone position.

NCT ID: NCT06075667 Recruiting - Obesity Clinical Trials

A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.

NCT ID: NCT06075095 Recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a New Propellant (HFO) in Participants 40 to 80 Years of Age With COPD

Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that the lung function effect from orally inhaled BGF delivered via HFO propellant is equivalent to the lung function effect from orally inhaled BGF delivered via HFA propellant in participants with COPD. The study duration for each participant will be approximately 15 to 16 weeks and consist of: 1. A screening and placebo run-in period of approximately 2 weeks prior to first dosing 2. Three treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) 3. A final safety follow-up visit via telephone contact approximately 1 to 2 weeks after the final dose administration Participants will be provided with rescue SABA (albuterol or salbutamol) to be used as needed throughout the study. Participants will attend in-clinic study visits approximately weekly during the screening/run-in period (Visits 1, 2, and 3), then every 4 weeks (Visits 4, 5, and 6) to receive take-home study treatment, measure their lung function, and assess their health and safety

NCT ID: NCT06074835 Recruiting - Infertility Clinical Trials

Automation of Gamete Preparation, Intracytoplasmic Sperm Injection (ICSI), Embryo Culture, and Vitrification

Start date: October 30, 2023
Phase: N/A
Study type: Interventional

Patients suffering from infertility may seek assisted conception treatment. In a full treatment cycle, the sperm and eggs (gametes) from the intended parents will be looked after by skilled laboratory staff (embryologists) who will rely on manual laboratory processes to achieve fertilization. The most commonly employed method to achieve fertilization is intracytoplasmic sperm injection (ICSI), a treatment that involves the injection of a single sperm cell directly inside an egg. The embryos so obtained are then be maintained in an appropriate environment (incubator) for several days before deciding whether they can be immediately used to attempt to establish a pregnancy (embryo transfer), or should be frozen in preparation for a future treatment (cryopreservation). The laboratory steps required to complete a full assisted conception treatment (from sperm and egg retrieval, to fertilization, and then to embryo transfer and/or cryopreservation) are often manual and time-consuming, and thus the success of the treatment is highly dependent on the skill of individual staff and outcomes can be affected by fatigue, stress, and workload. The combination of robotics and artificial intelligence (AI) has the potential to provide improvements to, and standardize, the fertility laboratory, but such integration has not been achieved routinely. Other medical fields, such as regenerative medicine, have long benefited from the implementation of robotic solutions; however, modern automation has yet to find its way into the fertility laboratory. The goal for Conceivable Life Sciences (the study sponsor) is the delivery of a suite of solutions that, collectively, will allow a fully autonomous ICSI cycle to take place (from sperm/egg preparation, to sperm injection, to embryo culture and cryopreservation) in an effort to reduce costs, assist laboratory staff, and possibly, improve outcomes. The purpose of this study is to deliver a core aspect of this project: the digital control and individual automation of all key steps of a complete laboratory workflow. The data generated in this study will help the future development of these automated systems. Patients undergoing an ICSI treatment may be recruited in this study. Their gametes (sperm and/or eggs) may be distributed across two groups (test and control) and undergo one or more elements of an automated full assisted conception workflow (for the test group) or a standard assisted conception workflow (for the control group). Robotic automation may include any of the following steps: robotic sperm preparation, robotic oocyte selection and denudation, robotic sperm injection, automated embryo culture, and automated cryopreservation. The resulting embryos may be employed for embryo transfer. The main hypothesis of this study is that the use of robotic assistants as part of a full assisted conception cycle may improve laboratory workflows without reducing the treatment success rates.

NCT ID: NCT06073444 Recruiting - Neonatal Jaundice Clinical Trials

mHealth to Screen for Neonatal Jaundice in Low-resource Mexican Settings: a Feasibility Study

JAUND-EASE
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Neonatal jaundice (NNJ) is a common condition in newborns during the first week of life due to increased levels of bilirubin. Usually, it resolves without consequences after 7 to 10 days. However, around 10% of the newborns develop a severe form, which if is not detected on time, can lead to irreversible consequences including brain damage, disabilities and even death. The goal of this study is to determine the feasibility of implementing a smartphone app (Picterus JP) to screen for NNJ in low resource health facilities in Mexico and to evaluate its potential effectiveness to detect severe cases of the condition compared to the current used method that consists in visual assessment (VA). Research questions are: 1. Is it feasible to implement the smartphone app Picterus JP to screen for NNJ in low resource health facilities in Mexico? 2. Will Picterus JP increase the detection of severe NNJ compared to VA? Participants will include: 1. Newborns who attend the health facilities for neonatal check up 2. Health care workers (HCWs) using the app 3. Parents of newborns screened with Picterus JP Methodology: Mothers will be asked to consent their newborn's participation. The newborns will be then randomly assigned to either: 1. control group in which jaundice will be screened by healthcare workers using VA or 2. intervention group in which jaundice will be screened using Picterus JP in addition to VA If the bilirubin measurement with Picterus is >15 mg/dl or there is suspicion of severe NNJ by VA, newborns will be referred to emergency room for further evaluation by a doctor and/or measure the level of bilirubin in blood. Researchers will compare the number of bilirubin blood levels >15 mg/dl between the two groups. HCWs and newborns' parents will be interviewed to identify their perceptions and experiences towards the use of the app.

NCT ID: NCT06073093 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

SPECIFI-RA
Start date: November 7, 2023
Phase: Phase 2
Study type: Interventional

This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (6 weeks ± 3 days) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

NCT ID: NCT06065748 Recruiting - Clinical trials for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

NCT ID: NCT06065566 Completed - Clinical trials for Insufficiency;Cardiac

Effect of Parenteral Glutamine on Myocardial Injury and Inflammation Biomarkers

Start date: February 4, 2020
Phase: N/A
Study type: Interventional

The effect of parenteral glutamine on the biomarkers of myocardial injury and inflammation in patients undergoing cardiac surgery with and without cardiopulmonary bypass (DCP) will be analyzed. Randomized controlled clinical trial, from October 2018 to February 2022. 124 patients: 14 patients with DCP and 14 patients without DCP, both + glutamine (L-alanyl-L-glutamine dipeptide, at a dose of 0.4 g / kg) 6 hours before surgery and 14 patients with PCD and 14 patients without PCD + placebo (saline) 6 hours before surgery. Blood samples will be taken to measure the level of TROP-I, CPK-MB, HSP-70, TNFa, IL6, IL10 and PCR 1 hour before the administration of Glutamine / Placebo, 1 hour before surgery, then at 1 , 12 and 24 hours after surgery.

NCT ID: NCT06065540 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

REIMAGINE 2
Start date: September 27, 2023
Phase: Phase 3
Study type: Interventional

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

NCT ID: NCT06065163 Recruiting - Clinical trials for Cardiorenal Syndrome Type 1

Ultrasound Guided Diuretic Therapy in Type 1 Cardiorenal Syndrome

NEEDED
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

A double-blind, randomized, controlled trial was conducted with the main objective of evaluating if patients with clinical assessment and VExUS reach decongestion faster within a maximum period of 7 days during the hospital stay. Likewise, the study will describe those patients who experience a decrease in serum creatinine (CrS), NT-proBNP at discharge, greater diuretic adjustment, rate of intrahospital readmission, and 30-day mortality.