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  • 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/A

    Span

    241 weeks

    Sponsor

    Pfizer

    Hollywood, 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

    2

    Span

    219 weeks

    Sponsor

    Alumis Inc

    Hollywood, Florida

    Recruiting

  • Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

    Phase

    3

    Span

    561 weeks

    Sponsor

    Pfizer

    Hollywood, Florida

    Recruiting

  • A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

    Phase

    3

    Span

    258 weeks

    Sponsor

    Bristol-Myers Squibb

    Hollywood, Florida

    Recruiting

  • Product Surveillance Registry

    Phase

    N/A

    Span

    1466 weeks

    Sponsor

    Medtronic

    Hollywood, 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/A

    Span

    3027 weeks

    Sponsor

    Medtronic

    Hollywood, Florida

    Recruiting

  • A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

    Phase

    3

    Span

    184 weeks

    Sponsor

    Otsuka Pharmaceutical Development & Commercialization, Inc.

    Hollywood, Florida

    Recruiting

  • Efficacy and Safety of VDPHL01 in Males With AGA

    Phase

    2/3

    Span

    91 weeks

    Sponsor

    Veradermics, Inc.

    Hollywood, Florida

    Recruiting

  • PREEMIE: Study for Treatment of PDA in Premature Infants

    Phase

    N/A

    Span

    69 weeks

    Sponsor

    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

    3

    Span

    244 weeks

    Sponsor

    Children's Oncology Group

    Hollywood, Florida

    Recruiting

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