Mechanistically based blood proteomic markers in the TGF-β pathway stratify risk of hepatocellular cancer in patients with cirrhosis.

Hepatocellular carcinoma (HCC) is the third leading cause of death from cancer worldwide but is often diagnosed at an advanced incurable stage. Yet, despite the urgent need for blood-based biomarkers for early detection, few studies capture ongoing biology to identify risk-stratifying biomarkers. We address this gap using the TGF-β pathway because of its biological role in liver disease and cancer, established through rigorous animal models and human studies.

Leveraging electronic health record query to streamline adverse event reporting and protocol compliance.

Electronic medical records are increasingly being leveraged to improve the efficiency and effectiveness of clinical trials. Reporting safety data and adhering to follow-up schedules are two challenges faced by study centers conducting a large number of clinical trials led by a single principal investigator. The Lenox Hill Electrophysiology Research Department collaborated with Northwell Health's informatics department to develop a live query accessing both inpatient and outpatient data.

Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial.

Objective: We assessed whether famotidine improved inflammation and symptomatic recovery in outpatients with mild to moderate COVID-19.

Design: Randomised, double-blind, placebo-controlled, fully remote, phase 2 clinical trial (NCT04724720) enrolling symptomatic unvaccinated adult outpatients with confirmed COVID-19 between January 2021 and April 2021 from two US centres. Patients self-administered 80 mg famotidine (n=28) or placebo (n=27) orally three times a day for 14 consecutive days.

More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant.

Background: Good clinical practice (GCP) training is the industry expectation for ensuring quality conduct of registrational clinical trials. However, concerns exist about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials.

Methods: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure quality conduct of clinical trials.

Lichenoid drug reaction following influenza vaccination in an HIV-positive patient: a case report and literature review.

Lichenoid drug reactions to vaccinations are rare but well-documented events. The vast majority of these reported reactions have been triggered by Hepatitis B vaccination (HBV). We describe an impressive generalized lichenoid drug reaction following the influenza vaccination.

Short-term outcomes using magnetic sphincter augmentation versus Nissen fundoplication for medically resistant gastroesophageal reflux disease.

Background: In 2012 the United States Food and Drug Administration approved implantation of a magnetic sphincter to augment the native reflux barrier based on single-series data. We sought to compare our initial experience with magnetic sphincter augmentation (MSA) with laparoscopic Nissen fundoplication (LNF).

Methods: A retrospective case-control study was performed of consecutive patients undergoing either procedure who had chronic gastrointestinal esophageal disease (GERD) and a hiatal hernia of less than 3 cm.

Cooks syndrome: a case report and brief review.

Congenital anonychia is rare, particularly when all 10 toenails are absent. When anonychia is associated with absence of distal phalanges, a diagnosis of Cooks syndrome must be considered. We present a case and discussion of a patient with congenital anonychia, absent distal phalanges, and rudimentary hypoplastic middle phalanges and brachydactyly, consistent with Cooks syndrome.

Carotid stenting and bivalirudin with and without vascular closure: 3-year analysis of procedural outcomes.

Objectives: The purpose of this study was to examine the outcome of carotid stenting using bivalirudin and the influence of vascular closure devices (VCD) on the incidence and severity of peri-procedural hypotension.

Background: Bivalirudin, a short-acting direct thrombin inhibitor, has been shown to be an effective anticoagulant in coronary interventions, with less risk of bleeding compared with heparin. Routine use of VCD has become the standard of care, facilitating patient ambulation after percutaneous carotid and coronary interventions.

One-year clinical outcomes, midterm survival, and predictors of mortality after carotid stenting in elderly patients.

Background: It has been demonstrated recently that carotid stenting can be performed safely in patients > or =80 years of age. However, it is uncertain whether these patients will derive benefit because longevity after revascularization is an important consideration. This study was conducted to determine survival and predictors of mortality of selected elderly patients after stenting.

Carotid artery stenting in elderly patients: importance of case selection.

Objectives: This study was conducted to determine if carotid stenting (CS) could be safely performed in the elderly.

Background: Age has been shown to be a predictor of neurological complications during CS. We postulated that CS could be safely performed in elderly patients if certain anatomical and clinical markers such as excessive vascular tortuosity, heavy concentric calcification of the lesion, and decreased cerebral reserve were avoided.

Realizing the potential of carotid artery stenting: proposed paradigms for patient selection and procedural technique.

Carotid artery stenting, compared with carotid endarterectomy, is emerging as an effective and less invasive method of revascularization for extracranial carotid artery stenosis. Carotid stenting is established as the treatment of choice for certain high-risk patient subsets, and ongoing clinical trials are evaluating this method across a broader clinical spectrum, including asymptomatic patients. For carotid stenting to reach its full potential, an acceptable risk of periprocedural complications, particularly in low-risk patients, must be ensured (the "3% rule").