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NCT ID: NCT04619290 Recruiting - Sars Cov 2 Clinical Trials

Outpatient Treatment With CoVid-19 With Prexablu

Start date: October 12, 2020
Phase: Phase 1
Study type: Interventional

Within the epidemic context of phase 3 in Mexico, the implementation of new treatments that have been shown to be beneficial for patients in other countries is an urgent need. Methylene blue (MB, the oxidized form, blue color) has been used in many different clinical medicine areas, ranging from malaria to orthopedics. Methylene blue absorbs energy directly from a light source and then transfers this energy to molecules of oxygen creating singlet oxygen (O2), which is the first electronic excited state of molecular oxygen (O2). Singlet oxygen is extremely electrophilic; thus, it can directly oxidize electron-rich double bonds in biological molecules and macromolecules. For this reason, methylene blue has been used as a photosensitizer in the treatment of cancer and the protection of serum from viral agents. Methylene blue can be reactivated using energy from a light source in the body until processed out through the kidneys.

NCT ID: NCT04616326 Recruiting - Chronic Migraine Clinical Trials

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine

REBUILD-2
Start date: November 25, 2020
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.

NCT ID: NCT04615949 Terminated - COVID-19 Clinical Trials

Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors

Start date: April 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.

NCT ID: NCT04615871 Recruiting - Covid19 Clinical Trials

Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19

SEMPATICO
Start date: September 10, 2021
Phase: Phase 2
Study type: Interventional

With the results of this study the investigators aim to identify an effective treatment that will reduce morbidity and mortality of patients with symptomatic COVID-19 infection, which would in turn reduce the burden on the healthcare system by decreasing the need for intensive care. Objectives: The main objective of this research is to determine if once weekly treatment with the GLP-1 agonist semaglutide for 4 doses will reduce cardiac as well as non-cardiac complications of COVID-19 infection. Study Plan: The study design is prospective randomized open-label blinded-evaluation (PROBE). Eligible patients with symptomatic COVID-19 infection and an enhanced risk profile as described above, who have been admitted to hospital due to symptoms of COVID-19 infection but do not as yet require critical care will be approached to participate in this study. Provided there are no exclusion criteria and the participants agree by means of documented written informed consent, The participants the participants will be randomized to receive s.c. semaglutide 0.25 mg s.c. or control immediately after randomization and then 0.5 mg s.c. at Day 7, Day 14 and Day 21. Blood will be drawn at Day 7±2 and Day 14±2 for the cardiac troponin biomarker and safety parameters. ECG will be obtained at Day 7±2 and Day 14±2. Primary outcome will be assessed on Day 28. Primary outcome measure: A composite of (1) death from any cause or (2) mechanical ventilation (invasive or non-invasive) at 28 days. Major secondary outcome measure: (1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a baseline cardiac troponin >99th percentile URL; measured at 1 week (7-days) post randomization. Other major secondary outcome measure: A composite of 1. Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days 2. an elevation to >99th percentile URL in those with a normal baseline troponin level; or 3x elevation from baseline in those with a baseline troponin; measured at 1 and 2 weeks (7±2 and 14±2 days) post randomization.

NCT ID: NCT04613921 Recruiting - Liver Cirrhosis Clinical Trials

Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs

CHANCE
Start date: July 8, 2021
Phase:
Study type: Observational

Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.

NCT ID: NCT04613596 Recruiting - Clinical trials for Advanced Non-Small Cell Lung Cancer

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

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

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.

NCT ID: NCT04613063 Completed - Cystic Fibrosis Clinical Trials

Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome

Start date: October 19, 2020
Phase:
Study type: Observational

A case of a patient with cystic fibrosis with bowel obstruction due to a proximal intestinal obstruction syndrome (PIOS) is presented.This syndrome can be diagnosed with the DIOS definition, with the only distinction of a more proximal location in the gastrointestinal tract, such as the stomach, the duodenum, or the jejunum.

NCT ID: NCT04612088 Active, not recruiting - Clinical trials for Adherence, Medication

Intervention for Multivitamin Adherence on Bariatric Patients

CDIPMABP
Start date: September 14, 2020
Phase: N/A
Study type: Interventional

This project has a parallel randomized controlled experimental design since within the methodology there will be a control of the conditions under study, that is, the selection of subjects, the way the treatment will be administered, the way in which the observations will be obtained, the use of instruments to perform the measurements and the interpretation of the criteria will be implemented in a homogeneous manner. Convenience sampling was used to obtain the subjects for the study, the sample size was 34 bariatric patients from a private bariatric center in Tijuana, Baja California, Mexico. Participants were randomly assigned to one of two groups. The group understudy or experimental or the control group on the waitlist; that is, no researcher or study participant made the decision of treatment that participants receive. The intervention consists of two psychoeducative sessions and five cognitive dissonance sessions. All participants will receive the same multivitamin for the duration of the study. Validated tests for adherence, medication knowledge, self-care, self-efficacy, and psychopathological symptoms were applied to both groups. Additionally, a blood sample was collected for the determination of Hemoglobin, Iron, Copper, Zinc, Calcium, Phosphate, Vitamin D, and Folate. Measurements using tests and blood samples will be made before and after receiving the intervention [pre and post-test]. For results analysis, Repeated measures ANOVA will be used, the study population shall be stratified into subgroups, by type of bariatric surgery, age, and sex; this in order to restrict comparisons to participants who are part of the same subgroup. The aim of the study is to assess the impact of an intervention based on the cognitive dissonance theory to promote adherence to the bariatric multivitamin. The hypothesis of the study is: Participants exposed to Festinger's theory-based intervention will exhibit changes in their attitude and behavior towards multivitamin intake as a product of cognitive dissonance.

NCT ID: NCT04611802 Completed - Covid19 Clinical Trials

A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2

Start date: December 27, 2020
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants. Additionally providing a Booster Dose to fully vaccinated participants. A substudy is to be conducted at selected sites to evaluate the safety and immunogenicity of a fourth dose (second booster) of NVX-CoV2373 in adults and adolescents, previously fully vaccinated and subsequently boosted with a third dose (first booster)

NCT ID: NCT04611256 Recruiting - Covid19 Clinical Trials

Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

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

The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.