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NCT ID: NCT04109391 Completed - Breast Cancer Clinical Trials

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

Start date: August 20, 2019
Phase: Phase 3
Study type: Interventional

This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.

NCT ID: NCT04109066 Completed - Breast Cancer Clinical Trials

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

CheckMate 7FL
Start date: November 20, 2019
Phase: Phase 3
Study type: Interventional

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

NCT ID: NCT04105049 Completed - Clinical trials for Students at Risk of Obtaining Low Academic Performance

Multivariate Predictive-discriminatory Model of Academic Performance in Medical Students. A Mixed Longitudinal Study.

Start date: August 26, 2019
Phase:
Study type: Observational

Reported studies on individual differences related to academic performance based on personality aspects describe self-efficiency, motivation and self-control as the main indicators of academic performance. Students who are motivated tend to have a better academic performance (AP) than peers with less motivation. On the other hand, differences in the environment related to academic performance have been linked to social aspects, among which are: family environment, family socioeconomic status and academic socialization. A constant factor in aspects of the environment that seems to permeate and impose itself on others is the socioeconomic one. About the personal factors of medical students, it has been found that university students who report stress caused by socioeconomic factors are more likely to have some psychological morbidity. There are certain ways to deal with stress that are related to better performance. Due to the complexity of the study of AP, it is necessary to develop holistic models that allow a better approach to reality. The educational research work related to academic disillusionment has been aimed at determining the factors involved in it. However, the methodological approach that has been used to document these works focuses on reductionism, where each variable that is studied and correlated independently with the AP. Although, this approach has provided valuable information, it is necessary to postulate holistic models that allow a better approach to reality. Although, there are published works on the correlation of the factors that can influence the academic performance of medical students of the Faculty of Medicine of the UNAM, no multivariate predictive models have been developed that include the main psychosocial factors and the resilience of students and how they impact academic performance; and also, study their behavior throughout a school year of the career, using stochastic models that allow characterizing a succession of random variables that evolve as a function of time. Therefore, the present work has as main purpose to establish a predictive model that allows predictions of expected academic performance and timely detection of students in situations of academic risk; and in turn tutorials, educational guidance, psychological support and / or specialized advice.

NCT ID: NCT04102189 Completed - Obesity Clinical Trials

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Start date: October 7, 2019
Phase: Phase 3
Study type: Interventional

This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.

NCT ID: NCT04099407 Completed - Liver Fibrosis Clinical Trials

Pirfenidone and Advanced Liver Fibrosis.

PROMETEO
Start date: August 1, 2019
Phase: Phase 2
Study type: Interventional

Pirfenidone (PFD), an oral antifibrotic drug with anti-inflammatory and anti-oxidant properties, has been granted marketing authorization by the European Medicine Agency and FDA, for the treatment of idiopathic pulmonary fibrosis (IPF). However, few studies have focused on its clinical utilization in patients with advanced hepatic fibrosis. Therefore, Investigators aim to evaluate a prolonged-release PFD formulation (PR-PFD) plus standard of care management on disease progression in patients with advanced liver fibrosis (ALF). Methods: Patients with diverse chronic liver disease etiology (alcohol-related, hepatitis B or C, autoimmune or fatty liver disease) will be screened with two non invasive liver fibrosis methods (Fibroscan®) and Fibro Test®) and those with ALF (F3 or F4) will be treated for at least 12 months with PR-PFD. Antifibrotic effects Will be assessed at 6 and 12 months; variations greater than 30% in estimated fibrosis scores or 1 point on the METAVIR scale will be considered clinically significant. PFD plasma levels, serum endothelin-1, IL6, TNFα and TGFβ1, Quality of life and fatigue scales will be evaluated. Parametric and non parametric statistics will be utilized and p values lower tan 5% will be considered clinically significant.

NCT ID: NCT04096469 Completed - Quality of Life Clinical Trials

Impact of Diet and Physical Activity Changes on Body Weight, Biomarkers and Quality of Life in Breast Cancer Survivors

Start date: May 1, 2016
Phase: N/A
Study type: Interventional

This study is a randomized controlled clinical trial of two arms, which included 60 women survivors of breast cancer of the state of Sonora, Mexico.The intervention is for 8 months and includes home visits every 15 days for the first four months and monthly for the last four months.The objective was to evaluate the effect of a diet and physical activity intervention program using the motivational interviewing (MI) strategy compared to an orientation with a traditional educational approach to improve anthropometric variables such as body weight, fat, muscle mass and bone mineral density, as well as biomarkers of the disease such as mammographic density, telomere length, telomerase activity, DNA methylation, ceramide-1-phosphate transport protein (CPTP), vascular endothelial growth factor (VEGF), C-reactive protein (CRP), interlucin 6 (IL-6) , interlucin 8 (IL-8), tumor necrosis factor alpha (TNF-α), leptin and adiponectin. Finally, the study also aims to improve psychological variables such as quality of life, sleep quality, anxiety and optimism.

NCT ID: NCT04095910 Completed - Childhood Obesity Clinical Trials

Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren

Start date: March 18, 2019
Phase: N/A
Study type: Interventional

Obesity prevention programs in schools are essential to promoting healthy lifestyles. There are programs with positive effects on obesity parameters, but only a few of them have didactic material for its dissemination. In United States they have effective programs (with materials for their implementation) and some are already being implemented in different schools. In Mexico our study group has developed a program called "Planet Nutrition" that includes a manual.The main aim of this study is to evaluate the efficacy of the program "Planet Nutrition"—a nutrition education and behaviour change program— on BMI Z score in school children compared to a control group at 9 weeks. This pilot stud is a randomized controlled trial. The study will be conducted with 41 participants. The primary outcome was the change in the BMI Z score from baseline to 9 weeks. Secondary outcomes were the changes from baseline to 9 weeks in body fat percentage, waist circumference, systolic and diastolic blood pressure, consumption of healthy and unhealthy food, physical activity and sedentary lifestyle, cardiorespiratory capacity and nutrition knowledge. Additionally BMI Z score will be measured at 23 weeks, after the summer vacations. Considering evidence that this period could have a negative impact on children´s weight.

NCT ID: NCT04093024 Completed - Clinical trials for Lung Diseases, Interstitial

A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)

InPedILD®
Start date: December 3, 2019
Phase: Phase 3
Study type: Interventional

The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).

NCT ID: NCT04090411 Completed - Clinical trials for Moderate to Severe Ulcerative Colitis

A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

Start date: December 19, 2019
Phase: Phase 2
Study type: Interventional

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

NCT ID: NCT04089566 Completed - Clinical trials for Muscular Atrophy, Spinal

Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

DEVOTE
Start date: March 26, 2020
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C). The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).