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NCT ID: NCT03771976 Completed - Clinical trials for Pregnancy Complications

Risk of Cesarean Section in Primiparous Women Over 35 Years of Age.

Start date: April 1, 2017
Phase:
Study type: Observational

The investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period and compared two cohorts of patients (primiparous women over 35 years of age and primiparous woman between 20 and 34 years of age). The objective was to determine the risk of cesarean section and other perinatal complications between the groups.

NCT ID: NCT03731182 Completed - Clinical trials for Pneumococcal Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)

Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.

NCT ID: NCT03721562 Completed - Clinical trials for Antibiotic Resistant Infection

Antibiotic Resistance in Global Pediatric Oncology Centers

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

Antibiotic resistance is one of the major health threats facing global as well as domestic populations, however it is not well characterized in pediatric patients. Pediatric patients receiving cancer-directed therapy have several risk factors implicated in development of antibiotic resistance including multiple courses of antibiotics, repeated exposures to the hospital environment, indwelling devices and chemotherapy-related damage to mucosal barriers. The investigators propose to capitalize upon the unique position of St. Jude Global within the global pediatric oncology community by using its regional alliance network to describe the molecular epidemiology of antibiotic resistance in Gram-negative bacteria in this population. Primary Objectives 1. Describe the epidemiology and the phenotypic and previously determined molecular determinants of antimicrobial resistance in Gram-negative organisms isolated from pediatric diagnostic specimens in selected Central American and US sites with capacity to treat pediatric cancer 2. Utilize strain typing by whole genome sequencing to describe relatedness between organisms at participating sites

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: NCT03671616 Completed - Poliomyelitis Clinical Trials

Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given as a Booster at Age 15-18 Months

Start date: May 15, 2018
Phase: Phase 3
Study type: Interventional

This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.

NCT ID: NCT03636906 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV

Start date: April 8, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.

NCT ID: NCT03616678 Recruiting - Clinical trials for Functional Mitral Regurgitation

VenTouch OUS Feasibility Study

Start date: March 25, 2019
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.

NCT ID: NCT03614676 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance

PEPNI
Start date: May 30, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their new-borns. The study will also determine incidence of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in the new-borns during their first year of life.

NCT ID: NCT03593590 Active, not recruiting - Multiple Sclerosis Clinical Trials

Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

MuSicalE
Start date: November 12, 2018
Phase:
Study type: Observational

This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.

NCT ID: NCT03572049 Completed - Clinical trials for Invasive Fungal Infections

Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole

MSG15
Start date: September 17, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective, multi-center, randomized, open-label parallel arm study involving patients with proven or probable invasive endemic fungal infection to ascertain the pharmacokinetics, safety, efficacy, tolerability and health economics of oral SUBA-itraconazole compared to conventional itraconazole. Patients will receive randomized open-label study drug (SUBA-itraconazole or conventional itraconazole) over a 42 day period and then continue therapy until Day 180. Patients will be stratified based on clinically reported infection with the human immunodeficiency virus (HIV).