Background Clinicians currently rely on patient-designated and next-of-kin surrogates to
make end-of-life treatment decisions for incapacitated patients. Surrogates are instructed to …

The Continual Reassessment Method (CRM), along with other adaptive dose-finding study
designs, has gained popularity since its proposal by O'Quigley. Several of the reasons it has …

The goals and objectives of phase 1 clinical trials are changing to include further evaluation
of endpoints such as molecular targeted effects, in addition to dose-toxicity profile of the …

Objective: To determine whether a multifaceted systems intervention would eliminate
catheter-related bloodstream infections (CR-BSIs). Design: Prospective cohort study in a …

Abnormal accumulation of myeloid-derived suppressor cells (MDSC) is an important
mechanism of tumor immune evasion. Cyclophosphamide (CTX) has also been shown in …

Background: Autism is rarely diagnosed before three years of age despite evidence
suggesting prenatal abnormalities in neurobiological processes. Little is known about when …

Cancer clinical trials have typically investigated agents or regimens in patients selected for
study based primarily on tumor histology and clinical characteristics. This approach, when …

Context To our knowledge, no prospective studies of the developmental course of early and
later diagnosis of autism spectrum disorders from 14 months of age exist. Objective To …

Purpose The primary purposes of eligibility criteria are to protect the safety of trial
participants and define the trial population. Excessive or overly restrictive eligibility criteria …

Background Immunotherapy with PD-1 or PD-L1 blockade fails to induce a response in
about 80% of patients with unselected non-small cell lung cancer (NSCLC), and many of …