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A Phase 2 Randomized Controlled Trial of Single-Agent Hydroxyurea Versus Thalidomide Among Adult Transfusion Dependent β Thalassemia Patients
Hydroxyurea and low dose thalidomide are low-cost, easily accessible Hb F inducing agents that have been found to decrease transfusion dependency...
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Selective Enhancement of Swine Myocardium with a Novel Ultrasound Enhancing Agent During Transthoracic Echocardiography
Ultrasound enhancing agents are approved to delineate the endocardial border and opacify the left ventricle cavity (LVC). We present a nested phase...
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Study design for development of novel safety biomarkers of drug-induced liver injury by the translational safety biomarker pipeline (TransBioLine) consortium: a study protocol for a nested case–control study
A lack of biomarkers that detect drug-induced liver injury (DILI) accurately continues to hinder early- and late-stage drug development and remains a...
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Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Four Global Roxadustat Phase 3 Trials
IntroductionRisk factors for thromboembolic events in patients with dialysis-dependent chronic kidney disease (CKD) receiving roxadustat are unknown....
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Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Phase 3 Roxadustat Trials in Japan
IntroductionThromboembolic events have occurred in clinical trials of roxadustat. This post hoc analysis explored potential factors related to...
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Effect of glucagon like peptide-1 receptor agonist exenatide, used as an intracranial pressure lowering agent, on cognition in Idiopathic Intracranial Hypertension
BackgroundCognitive function can be affected in conditions with raised intracranial pressure (ICP) such as idiopathic intracranial hypertension...
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Spliceosome mutations are associated with clinical response in a phase 1b/2 study of the PLK1 inhibitor onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia
PLK1 is overexpressed in acute myeloid leukemia (AML). A phase 1b trial of the PLK1 inhibitor onvansertib (ONV) combined with decitabine (DAC)...
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Response prediction of hepatocellular carcinoma undergoing transcatheter arterial chemoembolization: unlocking the potential of CT texture analysis through nested decision tree models
ObjectivesTo investigate if nested multiparametric decision tree models based on tumor size and CT texture parameters from pre-therapeutic imaging...
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Computerized Relational Agent to Deliver Alcohol Brief Intervention and Referral to Treatment in Primary Care: a Randomized Clinical Trial
BackgroundAlcohol screening and brief intervention have demonstrated efficacy but limited effectiveness and implementation in real-world primary care...
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Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial
PurposeInvestigate safety and tolerability of adrecizumab, a humanized monoclonal adrenomedullin antibody, in septic shock patients with high...
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A Phase 1, Open-Label Study to Evaluate the Effects of Food and Evening Dosing on the Pharmacokinetics of Oral Trofinetide in Healthy Adult Subjects
Background and ObjectiveTrofinetide, a synthetic analog of tripeptide glycine-proline-glutamate, is an investigational agent for the treatment of...
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ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing
BackgroundDolutegravir (DTG)-based antiretroviral therapy (ART) is highly effective and well-tolerated in adults and is rapidly being adopted...
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A PK-PD model linking biomarker dynamics to progression-free survival in patients treated with everolimus and sorafenib combination therapy, EVESOR phase I trial
PurposeThe objective was to develop a pharmacokinetic-pharmacodynamic (PK-PD) model linking everolimus and sorafenib exposure with biomarker dynamics...
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Molecular-based study of scrub typhus in Kerala, South India from 2014 to 2021: a laboratory-based study
Scrub typhus (ST) is a neglected acute, febrile, infectious disease caused by the intracellular parasite Orientia tsutsugamushi , a gram-negative...
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Eight characteristics of rigorous multilevel implementation research: a step-by-step guide
BackgroundAlthough healthcare is delivered in inherently multilevel contexts, implementation science has no widely endorsed methodological standards...
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Teriparatide and pelvic fracture healing: a phase 2 randomized controlled trial
SummaryPelvic fracture patients were randomized to blinded daily subcutaneous teriparatide (TPTD) or placebo to assess healing and functional...
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Stress response during early sedation with dexmedetomidine compared with usual-care in ventilated critically ill patients
BackgroundSedative agents may variably impact the stress response. Dexmedetomidine is a sympatholytic alpha 2 -adrenergic agonist mainly used as a...
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Performance of cardiac PET/CT with and without phase analysis for detection of scar in cardiac sarcoidosis: Comparison to cardiac magnetic resonance imaging
BackgroundThe presence of myocardial scar in CS patients results in poor prognosis and worse outcomes. 18 F-fluorodeoxyglucose ( 18 F-FDG) PET/CT...
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Translational PK-PD/TD modeling of antitumor effects and peripheral neuropathy in gemcitabine and nab-paclitaxel chemotherapy from xenograft mice to patients for optimal dose and schedule
PurposeGemcitabine and nab-paclitaxel (GnP) treatment, the standard first-line chemotherapy for unresectable pancreatic cancer, often causes...
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Management of pulmonary aspergillosis in children: a systematic review
Invasive pulmonary aspergillosis (IPA) is a severe condition in immunocompromised children, but the optimal management is still under debate. In...
