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NCT ID: NCT04129164 Completed - Sjögren's Syndrome Clinical Trials

A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome

SS
Start date: October 16, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).

NCT ID: NCT04118738 Completed - Hearing Loss Clinical Trials

International Cohort Study of Children Born to Women Infected With Zika Virus During Pregnancy

Start date: June 12, 2019
Phase:
Study type: Observational

The International Cohort Study of Children Born to Women Infected with Zika Virus (ZIKV) During Pregnancy study is a prospective, observational, international cohort study of children previously enrolled in the ZIP study or other ZIP 2.0 Protocol Team approved ZIKV-cohort study that will continue the longitudinal follow-up of children born with documented confirmed or presumptive in-utero ZIKV exposure ("ZIKV-exposed" cohort) and children born without documented confirmed or presumptive in-utero ZIKV exposure, matched by site and birth sex ("ZIKV-unexposed" cohort). Follow-up evaluations and assessments will allow for the determination and comparison of long-term neurodevelopmental outcomes among in utero ZIKV-exposed and ZIKV-unexposed children. Each participant will be followed for about 2 years, beginning at approximately 18 months through 42 months of age.

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: NCT04092582 Completed - Asthma Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller

Start date: October 31, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase IIa, randomized, placebo-controlled, double-blind, multicenter, two-arm study to evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A as an add-on therapy in patients with uncontrolled moderate to severe asthma who are receiving daily ICS therapy and at least one of the following additional controller medications: long-acting beta-agonist (LABA), leukotriene modulator (leukotriene modifier [LTM] or leukotriene receptor antagonist [LTRA]), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation.

NCT ID: NCT04088695 Completed - Blood Donors Clinical Trials

Effect of a Web Page Based on a Motivational Video for Voluntary Blood Donation

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

Voluntary blood donation is currently a key issue in many countries, as the shortage of voluntary donors results in a deficit in the supplies of the Blood Banks of the hospitals. One factor for which there is a low number of voluntary donors is the limited dissemination of information that is given to the population regarding the facilities and benefits of blood donation. Objective: To evaluate the effect of a web page containing a motivational video and an informative text to promote the voluntary donation of blood disseminated through the use of social networks such as Facebook and WhatsApp. Design and Participants: Online randomized controlled trial for a group of 102 university students. Intervention: One group exposed to the intervention with video and the other control group exposed to informative text.

NCT ID: NCT04085601 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH

Start date: August 27, 2019
Phase: Phase 3
Study type: Interventional

Evaluation of the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria .

NCT ID: NCT04054193 Completed - Clinical trials for Chemotherapy-induced Nausea and Vomiting

Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)

Start date: September 9, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment cycle and 14 days of follow-up for a total of 17 days.

NCT ID: NCT04021849 Completed - Sexual Harassment Clinical Trials

Evaluation of Virtual Course to Increase Knowledge in Sexual Harassment,Prevention and Sanction Policies of a University

Start date: September 10, 2019
Phase: N/A
Study type: Interventional

Sexual harassment is the behavior of sexual or sexist connotation unwanted by the affected person. Despite being considered as gender-based violence, victims of sexual harassment can be of both sexes. The university is the most frequent place where university students suffer sexual harassment. Law No. 27942 - "Ley de Prevención y Sanción del Hostigamiento Sexual" and its amendments, includes training and prevention in sexual harassment. The Universidad Peruana Cayetano Heredia (UPCH) has a regulation for the prevention and punishment of sexual harassment. Education through the use of Information and Communications Technologies (ICT) is presented as an alternative to face-to-face classes, optimizing resources and achieving greater scope. The early, mandatory and massive dissemination at the university of a training in sexual harassment could be achieved through a virtual course. However, there is little research on the evaluation of the effectiveness of prevention programs in sexual violence in university students. The objective is to prove that taking a virtual course about sexual harassment, prevention and sanction policies of the UPCH can achieve a greater or same knowledge of the subject in the students of the UPCH, compared to a face-to-face course. The study design is a randomized controlled trial to assess the level of knowledge in this subject, whose control group is provided classes in face-to-face mode. Also, both modalities of the course will include a survey with Likert scale to measure the degree of satisfaction with the course taken. And finally, it includes a qualitative study through focus groups with the university students of the classroom and virtual classes to know their appreciations of both modalities of the course.

NCT ID: NCT03988738 Completed - Blood Donors Clinical Trials

Promoting Repeat Blood Donation Through Social Media Among First-time Donors in a Peruvian Blood Bank

Start date: June 20, 2019
Phase: N/A
Study type: Interventional

Blood donations are an important need worldwide. In Peru, only 10% of donations are voluntary, of which only a quarter are repeat donors. Repeat donations are crucial to maintaining a safe and adequate blood supply. Social media presents a unique opportunity to promote blood donation, because of its increasing use and its prior successes in promoting positive health-related behaviors . The present study aims to develop and evaluate a social media intervention - Facebook and WhatsApp - to improve communication and promote repeat blood donations in voluntary first-time donors attending donation campaigns organized by the Hospital Nacional Cayetano Heredia (HCH).

NCT ID: NCT03986177 Completed - Asthma Clinical Trials

Asthma Implementation Research Trial

AIRE
Start date: June 3, 2019
Phase: N/A
Study type: Interventional

Asthma is the most common chronic disease among children worldwide, with 80% of asthma related deaths occurring in low- and middle-income countries (LMICs), such as Peru. While evidence-based guidelines exist for asthma treatment and management, adherence to guideline-based practices is low in high-income country (HIC) and LMIC settings alike. There a clear need for effective, locally-tailored solutions to address the asthma treatment gap in low-income communities in LMICs, such as Peru. This study aims to develop and test a locally-adapted intervention package to improve adoption of self-management practices and utilization of preventive health services for asthma among children in Lima. There is a paucity of research regarding the development and testing of interventions to improve asthma self-management in LMIC settings, which experience unique or exacerbated barriers to receiving evidence-based care. To the investigators' knowledge, no studies have systematically developed and evaluated an asthma management program in Peru. Therefore, the long-term goal of this study is to disseminate locally appropriate asthma management strategies to reduce asthma-related emergency department visits and improve service utilization in LMIC settings. For the current study, the investigators will carry out a randomized controlled trial to test the effectiveness of the intervention package in a group of 110 children with asthma who will be randomized to the intervention (55 children) or no intervention (55 children) arm. Participants in the intervention group will receive case management from a designated nurse manager, who will provide ongoing educational, social, and self-management support during monthly follow-up home visits and text-message based communication. Participants will be followed up every month for data collection over a six-month period. Throughout the follow-up period, the investigators will collect data on asthma control, healthcare utilization, medication adherence, quality of life of children with asthma and the children's caregivers, caregiver mental health, fidelity to the intervention, and acceptability and feasibility. Ultimately, this study will inform the scientific community about effective strategies and treatment programs for asthma in low-income settings.