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NCT ID: NCT05210023 Completed - Clinical trials for Overweight and Obesity

Nutrigenetic Intervention on Blood Lipid Markers and Body Composition of Adults With Overweight and Obesity

Start date: June 9, 2021
Phase: N/A
Study type: Interventional

Obesity is defined as the accumulation of excessive fat, attributed to the maintenance of a positive energy imbalance between calorie intake and expenditure. Obesity contributes to the development of many comorbidities such as type 2 diabetes, cardiovascular diseases, hypertension, metabolic syndrome, and dyslipidemias, among others. Dyslipidemias indicate a high concentration of lipids in the blood. Dyslipidemias cause more than 4 million premature deaths per year. The pathogenesis of obesity is complex as it involves environmental, sociocultural, physiological, medical, behavioral, genetic, epigenetic, and many other factors. On the other hand, the causes of dyslipidemias can be: genetic / hereditary (primary dyslipidemias) or an inadequate lifestyle (secondary dyslipidemias). Sufficient evidence indicates that lifestyle, mainly diet, plays a decisive role in the development of diseases such as obesity and dyslipidemias, in addition to that, recent research shows the importance of individual genetic predisposition to suffer from diseases. Data based on genome-wide association studies suggest a genetic predisposition for obesity and dyslipidemias with identification of various genes and genetic variations associated with these conditions. In this sense, the postulates of nutrigenetics as applied science are emphasized, since it states that food components can act on the human genome, directly or indirectly, to alter the expression of genes and gene products; diet can potentially compensate or accentuate the effects of genetic polymorphisms; and the consequences of a certain diet depend on the balance of health and disease states and the genetic background of an individual. Therefore, when advising a change in diet and lifestyle as prevention and as part of the treatment for obesity and dyslipidemias, it is considered that a nutrigenetic intervention, that is, the administration of a diet designed according to genotypic characteristics and personal phenotypic, will have a much greater positive impact on the health status of people with detected genetic variations that make them susceptible to these pathologies. For this reason, the implementation of nutrigenetic interventions could be a timely and successful avant-garde treatment to mitigate various cardiometabolic diseases such as dyslipidemias and others that are highly prevalent worldwide.

NCT ID: NCT05208047 Recruiting - Metastatic Cancer Clinical Trials

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Start date: April 14, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner.

NCT ID: NCT05206773 Recruiting - Fabry Disease Clinical Trials

A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease

PERIDOT
Start date: March 11, 2022
Phase: Phase 3
Study type: Interventional

This is a 12-month, parallel treatment, Phase 3, double-blind, randomized, placebo controlled study to evaluate the effect of venglustat on neuropathic and abdominal pain symptoms of Fabry disease in participants ≥16 years of age with Fabry disease who are treatment-naïve or untreated for at least 6 months. - Study visits will take place approximately every 3 months. - The double-blind period will be followed by an open-label extension (OLE) during which participants who have completed the double-blind period will be treated with venglustat for up to an additional 12 months.

NCT ID: NCT05205746 Completed - Clinical trials for SARS CoV 2 Infection

Phase II Study of AVX/COVID-12 Vaccine in Subjects With Prior SARS-CoV-2 Immunity Evidence

Start date: November 23, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase II study with single-blinded safety phase followed by double-blinded randomization, placebo-controlled, of administration of a single dose by two different administration routes (intramuscular route or intranasal route), to evaluate immunogenicity and safety of the recombinant SARS-CoV-2 vaccine (AVX/COVID-12 vaccine) based a live Newcastle disease viral vector (rNDV) in 396 healthy subjects with evidence of prior immunity to SARS-CoV-2, followed by a booster response assessment with an intramuscular dose of COVID-19 vaccine (ChAdOx-1 -S[recombinant]) in subjects originally randomized to the placebo arm at several research sites in Mexico City.

NCT ID: NCT05204238 Active, not recruiting - Heart Failure Clinical Trials

Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)

FUTURE-HIT
Start date: September 1, 2020
Phase:
Study type: Observational

Acute heart failure (AHF) is defined as rapid onset or rapid worsening of typical signs and symptoms of heart failure (HF) according to the 2016 European Society of Cardiology Guidelines. AHF is the first cause of hospitalization in people over 65 in Western countries, accounting for more than 1 million hospitalizations per year in the USA. This disease has many repercussions not only in terms of mortality and morbidity, but also in terms of resources and infrastructures necessary for these patients' treatment, which constitutes a high economic burden for the national health care system. Even with growing knowledge and means, nowadays, the prognosis of AHF is still poor and there are no proven therapies that lead to long-term benefits in terms of reduced mortality. A better management of the acute phase of decompensation, including the definition of effective diagnostic-therapeutic workup and the use of innovative drugs, could improve the course of the disease, with positive effects on the patient (gain in survival and reduction of admissions), but also on the community (containment of the overall health costs). In recent years, numerous scores have been outlined in various AHF settings, considering only a small number of parameters. Several prognostic models have been developed suggesting how difficult it is to evaluate the AHF patients' prognosis. All this effort towards the development of so numerous prognostic models is justified by the fact that, despite the evolution of treatments, the risk of re-hospitalization and of both intrahospital mortality and after discharge remains high. Several studies have investigated potential prognostic factors that could help evaluating the risk of cardiovascular events, but now there is no accurate and complete prognostic score, particularly for AHF patients. Therefore, to date there are no accurate scores or determinants of short- and medium-term prognosis that allow to improve the management of these patients. This will be an observational, prospective, multicentric, international, non-commercial (non-profit) study. The primary endpoint will be to evaluate the best parameters, among clinical, laboratory and echocardiographic variables assessed within 24 hours from the hospital admission and before discharge, that are able to predict rehospitalization for HF and cardiovascular death at 3 and 6 months, in patients admitted to the cardiology department for acute exacerbation of chronic HF or de novo AHF.

NCT ID: NCT05202067 Completed - Type 2 Diabetes Clinical Trials

Impact of Pharmaceutical Education on Medication Adherence

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Purpose. To evaluate the impact of pharmaceutical education in patients with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension on their medication adherence. Material and research methods. Randomized clinical trial with a control group with a duration of 6 months of follow-up. Patients with a diagnosis of Type 2 Diabetes Mellitus andWE Systemic Arterial Hypertension treated in the internal medicine outpatient of a school hospital will be included. Adherence to medication will be evaluated using Morisky's 8-item medication adherence scale. The investigators believe that Pharmaceutical education increases therapeutic adherence in patients with Type 2 Diabetes Mellitus and Systemic Arterial Hypertension.

NCT ID: NCT05201794 Recruiting - Dengue Clinical Trials

A Study of JNJ-64281802 for the Prevention of Dengue Infection

Start date: February 22, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline.

NCT ID: NCT05200468 Completed - Obesity Clinical Trials

Effect of Dietary Restrictions and Ketogenic Diet on Mitochondrial Function and Gut Microbiota in Subjects With Obesity

Start date: July 28, 2022
Phase: N/A
Study type: Interventional

The benefits of nutritional interventions with dietary restrictions are associated with improvement and preservation of mitochondrial function. Evidence suggests that dietary restrictions, including modifications in caloric intake (caloric restriction), or in the timing of food intake (e.g., intermittent fasting), play an important role in stimulating cell and mitochondrial autophagy, favoring the elimination of old and dysfunctional mitochondria. In addition to the observed effects on mitochondrial function, there is evidence that intermittent fasting, caloric restriction, and the ketogenic diet also generate changes in gut microbiota and microbial metabolite composition. The main aim of this study is to evaluate the effect of intermittent fasting, caloric restriction and ketogenic diet on mitochondrial function determined by respirometry in monocytes, modulated by the gut microbiota in subjects with obesity. An open randomized controlled clinical trial will be conducted with 80 participants divided by a draw in 4 nutritional interventions groups for 1 month, each for 20 participants, then participants will receive 550 mg of rifaximin and will finish the study with the assigned nutritional intervention for another month of follow-up. Knowledge of these dynamics will allow us to explore and understand the relationship between metabolites from the gut microbiota and their effect on mitochondrial function associated with the dietary interventions mentioned above.

NCT ID: NCT05199181 Completed - Clinical trials for Symptomatic Irreversible Pulpitis

Full Pulpotomy in Mature Teeth With Symptomatic Irreversible Pulpitis as a Routine Treatment in the Primary Care Clinics

Start date: November 19, 2019
Phase: N/A
Study type: Interventional

The present study has the objective of being a first approach of the full feasibility study in order to find out whether the Full Pulpotomy performed by a general practice dentist in a primary care dental clinic at the public health system with limited armamentarium could be suitable and present an appropriate success rate as well as patient satisfaction.

NCT ID: NCT05198934 Active, not recruiting - Clinical trials for Colorectal Cancer (CRC)

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

CodeBreak300
Start date: April 19, 2022
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).