Juiz De Fora ¿ Mg, Brazil
A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
This is an observational test-negative design study in which all study participants are adults ≥65 years of age hospitalized with RAD+CAP at one of the study sites. The only protocol-specified study procedure is a non-invasive urine specimen collection for pneumococcal detection using BinaxNOW® S. pneumoniae and the serotype-specific urinary antigen detection (UAD) assays. Cases and controls will be differentiated by the presence of vaccine serotypes that are identified by any method, including Quellung reaction of pneumococcal isolates obtained from standard of care (SOC) cultures from blood or high-quality respiratory tract specimens, or serotype specific UAD assays performed on urine specimens. The serotype-specific UAD assays, termed UAD-1 and UAD-2, detect the 13 serotypes in 13vPnC (1, 3, 4, 5, 6A/C, 6B/D, 7F/A, 9V/A, 14, 18C/A/ B/ F, 19A, 19F, 23F) (UAD-1) and 11 additional serotypes (2, 8, 9N, 10A/39, 11A/D/F, 12F, 15B/C, 17F/A, 20A/B, 22F/A, 33F/A) (UAD-2). For the primary objective, cases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified. All other participants who meet study inclusion criteria but for whom 20vPnC serotypes are not identified from any source and all other RAD+CAP of non-pneumococcal etiologies will serve as test-negative controls.
Phase
N/ASpan
241 weeksSponsor
PfizerHollywood, Florida
Recruiting
Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus
This study will consist of a 5 week screening period, 48 week treatment period, and a 4 week follow up period for a total of 57 weeks. Each participant will be randomized to receive ESK-001 or placebo for 48 weeks. An open label extension study will be available for those patients who complete the study.
Phase
2Span
219 weeksSponsor
Alumis IncHollywood, Florida
Recruiting
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Phase
3Span
561 weeksSponsor
PfizerHollywood, Florida
Recruiting
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
Phase
3Span
258 weeksSponsor
Bristol-Myers SquibbHollywood, Florida
Recruiting
Product Surveillance Registry
Phase
N/ASpan
1466 weeksSponsor
MedtronicHollywood, Florida
Recruiting
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
Phase
N/ASpan
3027 weeksSponsor
MedtronicHollywood, Florida
Recruiting
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Phase
3Span
184 weeksSponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.Hollywood, Florida
Recruiting
Efficacy and Safety of VDPHL01 in Males With AGA
Phase
2/3Span
91 weeksSponsor
Veradermics, Inc.Hollywood, Florida
Recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Phase
N/ASpan
69 weeksSponsor
Merit Medical Systems, Inc.Hollywood, Florida
Recruiting
Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
PRIMARY OBJECTIVES: I. Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age < 40 years (exclusive of breast cancer). II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients. SECONDARY OBJECTIVES: I. Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients. II. Determine the feasibility of measuring estrogen deprivation symptoms (i.e., hot flashes, sexual dysfunction) menstrual pattern, and quality of life among randomized patients. EXPLORATORY OBJECTIVE: I. Establish a unique cohort of female AYA patients treated with alkylating agent chemotherapy and randomized to receive or not receive triptorelin, that can be followed long-term to study reproductive health concerns and outcomes as well as genetic risk factors for premature menopause. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study. ARM B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 1 and 2 years.
Phase
3Span
244 weeksSponsor
Children's Oncology GroupHollywood, Florida
Recruiting