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NCT ID: NCT05925257 Recruiting - Breast Cancer Clinical Trials

Digital Health Intervention to Improve Health Care and Outcomes for Breast Cancer Patients

Start date: March 5, 2024
Phase: Phase 2
Study type: Interventional

Background: Nearly 30,000 Mexican women develop breast cancer annually. These patients frequently present multiple unmet supportive care needs. In high-income settings, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. The objectives of this study are (I) to design a two-component intervention for monitoring ePROs among breast cancer patients using a responsive digital application and proactive follow-up by nurses, (II) to perform intervention pilot testing of the study materials, and (III) to conduct the clinical trial to assess usability and effectiveness of the intervention. Methods. The investigators designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. The investigators will conduct a pilot test of the intervention with 50 breast cancer patients for six weeks to assess the feasibility and inform intervention adaptations. After that, the investigators will conduct a parallel arm randomized controlled trial assigning 205 patients each to intervention and control in one of Mexico's largest public oncology hospitals. The intervention will be provided for six months, with additional three months of post-intervention observation. The control group will receive usual healthcare and a list of information sources on relevant breast cancer topics. Women diagnosed with stages I, II, or III breast cancer who initiate chemo and/or radiotherapy will be invited to participate. The study outcomes will include supportive care needs, quality of life, use of emergency services and unscheduled hospitalizations, the usability of the ePRO App, and adherence to the intervention. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6, and 9 months.

NCT ID: NCT05924516 Not yet recruiting - Clinical trials for Diabetes Mellitus Type 2

Randomized Clinical Trial to Evaluate the Efficacy of a Digital Intervention for Patients With Type 2 Diabetes

DIAVERA
Start date: February 2024
Phase: N/A
Study type: Interventional

This study aims to perform a digital intervention in patients with type 2 diabetes to analyze the efficacy of the digital intervention Adhera® Fatigue Digital Program in order to improve diabetes self-management and improve clinical outcomes, including chronic condition-related fatigue. This will be done through a randomized clinical trial in 3 of the main health centers in the city of Xalapa, Veracruz, Mexico. The digital health intervention is designed to be used for approximately 3 months. The study will enroll 150 participants (75 in control group and 75 in experimental group) who are patients with type 2 diabetes. There will be educational contents and personalized motivational messages through the Adhera Health Recommender System.

NCT ID: NCT05920356 Recruiting - Clinical trials for Non-Small Cell Lung Cancer (NSCLC)

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

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

The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

NCT ID: NCT05919186 Completed - Infertility, Female Clinical Trials

Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

Start date: October 12, 2021
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the impact of repeated antioxidant supplementation on blastocyst utilization and expansion rates in embryos under different oxygen concentrations. The study aims to answer the following main questions: - Does adding antioxidants every 12 hours to embryo culture media improve usable and expanded blastocyst utilization rates on days 5 and 6? - How are the O2 concentrations related to the effect of different methods of antioxidants supplementation on blastocysts utilization and expansion rates? Participants in this study are infertile couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles. - Zygotes will be incubated at either 5% or 20% oxygen tension until the blastocyst stage. - Sibling zygotes will be divided into four groups: Group 1A and 1B: Antioxidants every 12 hours at either 5% or 20% O2 tension, respectively. Group 2A and 2B: Antioxidants only once at the beginning of embryo culture at either 5% or 20% O2 tension, respectively. Researchers will compare the four groups to determine if the repeated antioxidant supplementation of the culture media leads to improved blastocyst utilization and expansion rates compared to the baseline group.

NCT ID: NCT05918575 Recruiting - Obesity, Morbid Clinical Trials

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Around 20% of the obese patients with higher body mass index (BMI) who are taken off the breathing tube and breathing machine (ventilator) end up needing it back to support breathing. The re-application of breathing tube is associated with poor outcomes, including high risk of pneumonia, longer hospital stays, and death. The purpose of this study is to assess if prophylactic use of noninvasive breathing support after removing the breathing tube lowers the chance of needing the breathing tube again.

NCT ID: NCT05913986 Recruiting - Clinical trials for Metabolic Associated Fatty Liver Disease

Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty Liver Disease

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This randomized, controlled, double-blind study evaluates the utility of alpha-lipoic acid and silybum marianum , versus placebo, in the treatment of metabolic associated fatty liver disease.

NCT ID: NCT05911880 Recruiting - Clinical trials for Rheumatoid Arthritis

The Effect of a Plant-based Diet on the Active Rheumatoid Arthritis Activity.

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

The increase in autoimmune diseases in Western countries has been linked to environmental factors, and diet is considered a modifier of rheumatoid arthritis (RA). A high-fat diet promotes systemic inflammation and alters the microbiome. Certain bacteria in the intestinal microbiota generate proinflammatory metabolites from components of red meat, eggs, and dairy products. However, fruits and vegetables can modulate the gut microbiota and have been associated with reduced inflammation in RA patients. The aim of this study is to determine the changes in RA activity associated with plant-based dietary modifications. The study will evaluate men and women aged 18 years and older with low, moderate, or severe RA activity, and the intervention will involve an individualized, isocaloric plant-based diet for 14 days. The 28-joint disease activity score index and c-reactive protein (DAS 28-PCR) will be used to determine disease severity, in addition to analyzing the expression of inflammatory cytokines and microRNAs associated with RA.

NCT ID: NCT05911841 Recruiting - Atopic Dermatitis Clinical Trials

A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

Start date: June 21, 2023
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT05911360 Active, not recruiting - HIV Infections Clinical Trials

A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF

EYEWITNESS
Start date: July 7, 2023
Phase: Phase 3
Study type: Interventional

The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.

NCT ID: NCT05909995 Recruiting - Melanoma Clinical Trials

Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors

Start date: August 29, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.