Site for Multicenter Randomized Pragmatic Clinical Trial Comparing Two- Versus Three-Antibiotic Therapy for Pulmonary Mycobacterium avium Complex Disease
Site for To determine whether 2-drug is non-inferior to 3-drug (standard) therapy against pulmonary Mycobacterium avium complex (MAC) and whether 2-drug therapy is better tolerated than 3-drug therapy.
Site for NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I HORMONE SENSITIVE HER2-NEGATIVE ONCOTYPE RECURRENCE SCORE = 18 BREAST CANCER
Site for Primary ObjectiveTo evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of ipsilateral-breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.Primary HypothesisBreast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral-breast tumor recurrence (IBTR) as compared to breast conservation, breast radiation, and endocrine therapy.
Site for OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
Site for OptimICE-pCR is a randomized phase III trial that is enrolling early-stage TNBC patients with a pCR after the completion of neoadjuvant therapy consisting of a minimum of 6 cycles of chemotherapy in combination with an ICI. Patients are randomized 1:1 to receive 27 weeks of adjuvant pembrolizumab or observation. Schedule of pembrolizumab is per physician’s choice, with a choice of either pembrolizumab 200 mg IV administered on day 1 of each 21-day cycle or 400 mg IV administered on day 1 of every 42-day cycle. If every 42 day (6 week dosing) is chosen, then 4 doses of 400 mg IV every 42 days can be administered followed by one cycle of 200 mg IV every 21 days, so that a total of 27 weeks of pembrolizumab is received.
Site for PE-TRACT NYU Enrollment Site
Site for PE TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare CDT and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.Primary Objective: Determine whether patients with submassive PE who are treated with CDT plus medical therapy (CDT group) have better cardiopulmonary health in the year following PE than patients treated with medical therapy alone (No-CDT).Primary Safety Objective: Determine whether CDT is associated with a higher rate of major adverse events at 7 days than No-CDTSecondary Objectives: Determine: 1) Whether patients treated with CDT have better generic quality of life than No-CDT2) Rates of clinical deterioration in the first 7 days in both groups. 3) The cost-effectiveness of CDT compared with No-CDT. 4) Length of 6MWD at 12 months in both groups.Primary Efficacy Outcomes: At 3 months: Peak oxygen uptake (PVO2) on cardiopulmonary exercise testing and at 12 months: New York Heart Association (NYHA) classThe primary safety outcome will be major bleeding within 30 days of randomization. Secondary outcomes include generic quality of life (QOL) (SF-36), 6-minute walk distance, clinical deterioration from PE, and cost-effectiveness. Exploratory analyses will assess: disease-specific QOL, other cardiopulmonary exercise test parameters, recurrent venous thromboembolism and complications of the CDT procedure. Predictors of therapeutic response will also be sought.The safety endpoints are major, intracranial, and minor bleeding, and CDT related complications.
Site for Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES): A multi country non-interventional prospective cohort study among patients with human growth hormone (hGH) treatments under routine clinical care
Site for This study will explore how safe and effective hGH treatments are in the long term. This study is “non-interventional” because it collects information only.
Site for Primary Ciliary Dyskinesia Foundation (PCDF) Registry: A longitudinal study of patients with primary ciliary dyskinesia
The PCD Foundation registry will be conducted at PCD approved care centers throughout the US.Parental consent will be obtained to collect pertinent clinical data four times per year.
Site for Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck
This study will therefore address the question whether docetaxel alone is as active as docetaxel and cetuximab combination and whether either taxane-based regimen is better than cisplatin monotherapy given to this high-risk group of patients with concurrent radiation. The less toxic weekly cisplatin regimen is selected to enhance compliance in the control arm and to parallel to weekly regimen proposed for the 2 experimental arms. If positive, this study will provide a new standard of care with a non-cisplatin regimen for patients with high-risk head and neck squamous cell carcinoma in the postop setting.
Site for Registry of Asthma Patients Initiating
Site for Participant in this observational research study sponsored by Regeneron Pharmaceuticals, Inc., are being asked to participate because they are receiving treatment with dupilumab, since you are currently being treated for asthma by a study participating physician. The study is being done to characterize and collect long term data on patients 12 years and older with moderate to severe asthma, who receive treatment with dupilumab (also known as DUPIXENT®).
Site for Rheumatoid Arthritis-patient reported outcomes (RA-PRO) study for treatment strategies after methotrexate inadequate-response (MTX-IR)
Site for RA-PRO is a 12-month, 2-arm, open-label, RCT pragmatic study to test whether adding TNF-biologic strategy is superior to the alternative approach of small molecule Jak-kinase inhibitor in RA patients with active disease despite adequate trial of methotrexate, i.e. MTX-inadequate responder (IR), in a variety of clinical care settings across the U.S. at multiple sites. There is equipoise between these two strategies in RA.
Site for S2212 SHORTER ANTHRACYCLINE-FREE CHEMO IMMUNOTHERAPY ADAPTED TO PATHOLOGICAL RESPONSE IN EARLY TRIPLE NEGATIVE BREAST CANCER (SCARLET) A RANDOMIZED PHASE III STUDY
Site for This is a randomized Phase III trial comparing a standard neoadjuvant chemotherapyregimen to an experimental neoadjuvant chemotherapy regimen that omits AC therapy. Both arms receive pembrolizumab for one year. If participants in the experimental arm have residual disease after neoadjuvant therapy, then they may receive adjuvant therapy post-surgery at physician discretion. This is a parallel randomization open-label design with equal allocation to the two treatment groups: (1) standard neoadjuvant chemotherapy and (2) neoadjuvant chemotherapy without AC. Randomization will be stratified by nodal status (negative or positive).