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NCT ID: NCT05310071 Active, not recruiting - Alzheimer's Disease Clinical Trials

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease

ENVISION
Start date: June 2, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

NCT ID: NCT05309044 Not yet recruiting - Obesity Clinical Trials

Evaluation of the Planetary Health Diet Included in a Lifestyle Program in Overweight or Obese Mexican Adults.

Start date: April 2022
Phase: N/A
Study type: Interventional

The EAT-Lancet Commission proposed the planetary health diet as a strategy to achieve health and sustainability goals. Currently, its effect in the treatment of obesity has not been evaluated. The main aim is to evaluate the efficacy of the planetary health diet included in an intensive lifestyle change program compared to a waiting list group, on weight and body fat at 4 months, in Mexican adults with overweight or obesity, in an online modality. This study is a 4-month randomized controlled trial, in an online modality in individuals with overweight or obesity randomly assigned 1:1:1 to one of three groups: 1) planetary health diet, 2) waiting list and 3) low fat-diet. The primary outcome is the difference in change in weight (kg) and body fat (kg) at 4 months between the planetary health diet group and the waiting list group. Comparison with the low-fat diet group will be an exploratory analysis. Secondary variables include changes in waist circumference, BMI, blood pressure, and health-related quality of life. Between group comparisons will be analyzed by intention-to-treat. The protocol was approved by a Research Bioethics Committee.

NCT ID: NCT05307159 Completed - Athletes Clinical Trials

Effect of a Bean Protein-added Supplement on Body Composition in High-performance Adolescent Athletes

Start date: May 2, 2022
Phase: N/A
Study type: Interventional

Background: Sport is a specialized competitive physical activity that is regulated and requires daily physical training. The workouts allow athletes to increase strength, endurance exercise performance, and muscle mass. Due to this, it is extremely important to consider that high-performance athletes require a meal plan with a higher energy requirement compared to a normal person who does not perform high-intensity activity. The diet of these athletes needs higher protein requirements to support the accumulation and/or maintenance of lean mass. Specifically athletes between 4 to 17 years of age, the protein requirement is of utmost importance to maintain muscle mass between 68-73%. Therefore, the recommendations for protein intake for athletes in this age range is approximately between 10 and 30% of the total energy intake. One of the strategies that has been used is supplementation with protein isolates, since in this way there is greater protein accessibility to maintain a balance between protein synthesis and degradation. The main protein supplements that are currently consumed come from proteins of animal origin; however, these usually have high costs, which makes them difficult to access for the population. Due to this, strategies have begun to be sought through the use of different proteins to generate similar effects. Objective: To evaluate the effect of a bean protein supplement on body composition in high-performance adolescent athletes. Methodology: The protocol will be divided into two stages, in the first one a supplement added with bean protein will be elaborated. First, the extraction of protein from the bean will be carried out, then it will be subjected to a heat treatment to eliminate anti-nutrients and finally its chemical composition will be analyzed. In the second stage, a pilot study will be carried out to evaluate the effect of the bean protein supplement in high-performance adolescent athletes. High-performance table tennis athletes, adolescents who agree to collaborate with the study will be included. Bean protein supplementation will be for 21 continuous days in the athletes' snack. Anthropometric measurements will be taken at the beginning and at the end of the intervention. A control of the diet and supplementation of the athletes will be carried out with the support of their coaches.

NCT ID: NCT05306002 Completed - DNA Damage Clinical Trials

Nutritional Intervention and DNA Damage of Patients With HBOC

Start date: November 28, 2017
Phase: N/A
Study type: Interventional

Breast and Ovarian Cancer Syndrome (HBOC) is characterized by mutations in tumor suppressor genes such as BRCA1 and BRCA2, which increase the carrier's risk of developing breast and ovarian cancer, especially before 40. In this pathology the DNA damage is increased because there is a state of chronic inflammation, plus the antineoplastic treatments and changes in body composition result in oxidative stress. The inductions of epigenetic changes by a nutritional intervention with an specific distribution of macronutrients, micronutrients and polyphenols, not only ensures an optimal nutritional status, but also shows a decrease in oxidative stress, and therefore in DNA damage. The aim of this study is to assess if the DNA damage in patients with HBOC decreases after the nutritional intervention.

NCT ID: NCT05305547 Completed - Clinical trials for SARS-CoV-2 Infection

A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19

SCORPIO-HR
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.

NCT ID: NCT05305001 Completed - Pancreatic Cancer Clinical Trials

Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico

Start date: September 9, 2020
Phase:
Study type: Observational

Pancreatic cancer is a highly lethal disease. The cause of pancreatic cancer is multifactorial. However, around 10% of cases are associated with hereditary predisposition. Germline mutations in BRCA1 and BRCA2, CDKN2A, STK11, DNA mismatch repair (MMR) genes (MLH1, MSH2, MSH6, or PMS2), PALB2, FANCC, FANCG, and ATM have been associated with an increased risk for pancreatic cancer. The prevalence of these germline mutations varies across populations. For instance, the prevalence of BRCA1/2 germline mutations in high-risk populations can be up to 20%. On the other hand, in unselected patient population, the prevalence of BRCA1/2 germline mutations is 5-7%. In Mexican population, data on the prevalence of BRCA1/2 germline mutations in patients with pancreatic cancer are lacking. Identification of BRCA germline mutations in patients with pancreatic cancer has implications for treatment. Also, it allows genetic testing and counselling for family members. This study will determine the prevalence of germline mutations associated with hereditary pancreatic cancer using a comprehensive gene panel in an unselected cohort of patients with pancreatic adenocarcinoma in Mexico.

NCT ID: NCT05303064 Recruiting - Schizophrenia Clinical Trials

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

Start date: June 30, 2022
Phase: Phase 3
Study type: Interventional

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

NCT ID: NCT05301842 Recruiting - Clinical trials for Hepatocellular Carcinoma

Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

EMERALD-3
Start date: March 28, 2022
Phase: Phase 3
Study type: Interventional

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

NCT ID: NCT05300191 Suspended - Clinical trials for End Stage Renal Disease

In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device

Start date: September 15, 2018
Phase:
Study type: Observational [Patient Registry]

A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.

NCT ID: NCT05298423 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)

Start date: May 3, 2022
Phase: Phase 3
Study type: Interventional

This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: - progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. - overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.