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NCT ID: NCT03675737 Active, not recruiting - Stomach Neoplasms Clinical Trials

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

Start date: November 8, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

NCT ID: NCT03675308 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy

KEEPsAKE 1
Start date: March 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).

NCT ID: NCT03674983 Completed - HIV Infections Clinical Trials

PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

The objective of this R34 application is to prepare for testing innovative user-centered ways to promote PrEP adherence at scale. Our central hypothesis is that adherence to PrEP can be improved among MSW if PrEP is provided for free along with highly-tailored conditional economic incentives (CEI). The specific aims are: Aim 1: To refine the design of PrEP adherence intervention with user-centered conditional economic incentives to maximize sustained adherence behaviors through a user-responsive computerized survey (n=200). We incorporate quantitatively identified preferences for CEIs through a user- responsive computerized survey. We use conjoint analysis to understand preferences for CEI intervention components and how CEIs should be integrated into an optimal combination package to be tested in Aim 2. Aim 2: Measure the extent to which a user-centered CEI intervention can help MSW increase their adherence to free PrEP in a randomized controlled pilot (n=100). Among MSW who accept to take free PrEP, and return at month 1 for a second pill bottle, we will randomize n=100 MSW to either: standard of care (SoC: information, prescription, free PrEP) or CEI (SoC + incentives contingent on sufficiently-high adherence to PrEP). We will assess the primary outcome (biomarker of adherence using scalp hair analysis) at months 3 and 6, as well as secondary outcomes: clinic attendance/retention, medication possession ratio, self-reported PrEP use, and sexual behavioral disinhibition (number of partners, condom use, incident STI). Aim 3: Estimate the preliminary cost-effectiveness of incentives for PrEP adherence to maximize future policy and practice relevance of this promising intervention strategy. Our working hypothesis is that conditional economic incentives for PrEP adherence will be cost-effective in terms of cost per fully- adherent month on PrEP, cost per HIV infection averted, and cost per disability-adjusted life year saved when compared to controls not receiving the conditional incentives. The expected outcome of this R34 is a demonstration that is feasible to implement user-centered CEIs in this context, as well as preliminary efficacy and cost-effectiveness data. The project will have positive impact because it is a critical step toward scaled-up implementation of PrEP in this highly-at-risk population of MSWs in Mexico, with implications for other concentrated epidemics among MSW worldwide.

NCT ID: NCT03674203 Completed - Melasma Clinical Trials

Efficacy of Platelet-rich Plasma in Treatment of Melasma

Start date: May 1, 2017
Phase: Phase 2
Study type: Interventional

The application of Platelet Rich Plasma (PRP) on three occasions with an interval of 15 days between each one, is related to a decrease in the intensity of the spots and improvement in the quality of the skin of patients with melasma.

NCT ID: NCT03674112 Completed - Clinical trials for HER2-Positive Early Breast Cancer

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

PHranceSCa
Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.

NCT ID: NCT03673306 Active, not recruiting - Breast Cancer Clinical Trials

Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

Start date: January 16, 2017
Phase:
Study type: Observational

The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.

NCT ID: NCT03672409 Recruiting - Knowledge Clinical Trials

Diabetes Training Program for Health Professionals From Hermosillo, Sonora

Start date: September 5, 2018
Phase: N/A
Study type: Interventional

Primary health care is the medical assistance available to all individuals in a community and is considered the core of the health system. Diabetes, among other chronic diseases, is a common reason for medical consultation in primary health care. Worldwide and in Mexico, the prevalence of diabetes has been increasing in recent decades, which also leads to an increase in the number of deaths. On the other hand, the annual cost of medical care for diabetes in the country has increased due to the exacerbation of complications and comorbidities associated, which are presented, among other causes, by a deficiency of knowledge in the diagnosis, evaluation, management and follow-up of type 2 diabetes, of health professionals (doctors, nurses, nutritionists) working in primary health care. The present study will allow evaluating the effect of a training program, is a single-cohort clinical study with pre- and post-intervention measurements lasting 6 weeks, including the initial and final measurements of health professionals currently working in primary health care of Hermosillo Sonora.

NCT ID: NCT03670875 Completed - Clinical trials for Obesity in Childhood

Non-Pharmacologic Alternatives for Childhood Obesity

Start date: July 31, 2021
Phase: N/A
Study type: Interventional

Childhood obesity is a global health issue. Mexico has been considered as the country with the higher number of children with obesity. There are not approved drugs to support diet and exercise as the first step to lose weight. Animal models and clinical trials in adults have provided evidence about safety and efficacy of interventions such as: prebiotics, curcumin, and omega- 3 fatty acids. The hypothesis of this study is: that non-pharmacological alternatives could support diet and exercise to decrease the weight of children with obesity.

NCT ID: NCT03670810 Completed - Migraine Clinical Trials

A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Start date: June 24, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

NCT ID: NCT03669718 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Oropharynx

A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC

Start date: November 30, 2018
Phase: Phase 2
Study type: Interventional

This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.