Brain network mechanisms of visual shape completion.

Visual shape completion recovers object shape, size, and number from spatially segregated edges. Despite being extensively investigated, the process's underlying brain regions, networks, and functional connections are still not well understood. To shed light on the topic, we scanned (fMRI) healthy adults during rest and during a task in which they discriminated pac-man configurations that formed or failed to form completed shapes (illusory and fragmented condition, respectively).

Impact of depth of clinical response on outcomes of acute myeloid leukemia patients in first complete remission who undergo allogeneic hematopoietic cell transplantation.

Acute myeloid leukemia (AML) patients often undergo allogeneic hematopoietic cell transplantation (alloHCT) in first complete remission (CR). We examined the effect of depth of clinical response, including incomplete count recovery (CRi) and/or measurable residual disease (MRD), in patients from the Center for International Blood and Marrow Transplantation Research (CIBMTR) registry. We identified 2492 adult patients (1799 CR and 693 CRi) who underwent alloHCT between January 1, 2007 and December 31, 2015.

Barriers and Facilitators of Smoking Cessation among Latinos Living with HIV: Perspectives from Key Leaders of Community-Based Organizations and Clinics.

The purpose of this study was to identify the perspectives from key leaders of community-based organizations (CBOs) and clinics serving people living with HIV on barriers and facilitators of smoking cessation among Latino smokers living with HIV. Semi-structured interviews were conducted in English and Spanish with 10 key leaders. Using a social ecological model, qualitative theoretical analysis was used to analyze the results.

The Development and Prototype Feedback of Digital Cancer 101 Videos to Enhance Cancer Education for Marginalized Communities With Limited Health Literacy.

Social media, in the form of digital videos targeted to people with limited health literacy, as well as disadvantaged or marginalized groups, may help reduce cancer health disparities and improve health outcomes in these populations. In this article, we document the process of adapting the content from the Cancer 101 curriculum to create animated scripts about the cancer care continuum that is clear, straightforward, and in plain language. The development of the Cancer 101 digital videos required a multidisciplinary collaboration from-public health, medicine, technology, and expertise in correctional health, smoking cessation, web development, video producers, and individuals directly impacted by cancer disparities.

Data Sharing Goals for Nonprofit Funders of Clinical Trials.

Sharing clinical trial data can provide value to research participants and communities by accelerating the development of new knowledge and therapies as investigators merge data sets to conduct new analyses, reproduce published findings to raise standards for original research, and learn from the work of others to generate new research questions. Nonprofit funders, including disease advocacy and patient-focused organizations, play a pivotal role in the promotion and implementation of data sharing policies. Funders are uniquely positioned to promote and support a culture of data sharing by serving as trusted liaisons between potential research participants and investigators who wish to access these participants' networks for clinical trial recruitment.

Cost-impact analysis of baroreflex activation therapy in chronic heart failure patients in the United States.

Background: The study evaluated the cost of baroreflex activation therapy plus guideline directed therapy (BAT + GDT) compared to GDT alone for HF patients with reduced ejection fraction and New York Heart Association Class III or II (with a recent history of III). Baroreflex activation therapy (BAT) is delivered by an implantable device that stimulates the baroreceptors through an electrode attached to the outside of the carotid artery, which rebalances the autonomic nervous system to regain cardiovascular (CV) homeostasis. The BeAT-HF trial evaluated the safety and effectiveness of BAT.

Safety and Efficacy of Endoscopic Retrograde Cholangiopancreatography in Nonagenarians: A Systematic Review and Meta-Analysis.

Background: Recent advances in modern medicine have translated into increase in life expectancy in the USA and with that, a rise in the demand for invasive procedures in elderly patients. Endoscopic retrograde cholangiopancreatography (ERCP) is the procedure of choice for managing various benign and malignant pancreatobiliary conditions and can be associated with various adverse events.

Aim: We performed a systematic review and meta-analysis to evaluate outcomes of ERCP in nonagenarians.

Design, Analysis, and Pitfalls of Clinical Trials Using Ex Situ Liver Machine Perfusion: The International Liver Transplantation Society Consensus Guidelines.

Background: Recent trials in liver machine perfusion (MP) have revealed unique challenges beyond those seen in most clinical studies. Correct trial design and interpretation of data are essential to avoid drawing conclusions that may compromise patient safety and increase costs.

Methods: The International Liver Transplantation Society, through the Special Interest Group "DCD, Preservation and Machine Perfusion," established a working group to write consensus statements and guidelines on how future clinical trials in liver perfusion should be designed, with particular focus on relevant clinical endpoints and how different techniques of liver perfusion should be compared.

Crowdsourcing digital health measures to predict Parkinson's disease severity: the Parkinson's Disease Digital Biomarker DREAM Challenge.

Consumer wearables and sensors are a rich source of data about patients' daily disease and symptom burden, particularly in the case of movement disorders like Parkinson's disease (PD). However, interpreting these complex data into so-called digital biomarkers requires complicated analytical approaches, and validating these biomarkers requires sufficient data and unbiased evaluation methods. Here we describe the use of crowdsourcing to specifically evaluate and benchmark features derived from accelerometer and gyroscope data in two different datasets to predict the presence of PD and severity of three PD symptoms: tremor, dyskinesia, and bradykinesia.

First trimester mechanisms of gestational sac placental and foetal teratogenicity: a framework for birth cohort studies.

Background: The function of the gestational sac (GS) and the placenta in the closely related processes of embryogenesis and teratogenicity in the first trimester has been minimally described. The prevailing assumption is that direct teratogenic effects are mediated by the critical extraembryonic organ, the placenta, which either blocks or transfers exposures to the foetus. Placental transfer is a dominant mechanism, but there are other paradigms by which the placenta can mediate teratogenic effects.

Efficacy and safety of EMA401 in peripheral neuropathic pain: results of 2 randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy.

The analgesic efficacy and safety of 2 phase 2b studies of EMA401 (a highly selective angiotensin II type 2 receptor antagonist) in patients with postherpetic neuralgia (EMPHENE) and painful diabetic neuropathy (EMPADINE) were reported. These were multicentre, randomised, double-blind treatment studies conducted in participants with postherpetic neuralgia or type I/II diabetes mellitus with painful distal symmetrical sensorimotor neuropathy. Participants were randomised 1:1:1 to either placebo, EMA401 25 mg, or 100 mg twice daily (b.

Veterans with Gulf War Illness perceptions of management strategies.

Aims: Gulf War Illness (GWI) is a prevalent and disabling condition characterized by persistent physical symptoms. Clinical practice guidelines recommend self-management to reduce the disability from GWI. This study evaluated which GWI self-management strategies patients currently utilize and view as most effective and ineffective.

Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study.

Background: Most systemic agents used for moderate-to-severe atopic dermatitis (AD) may lead to adverse events requiring routine laboratory monitoring, increasing patient burden and possibly decreasing treatment adherence.

Objective: To evaluate clinical laboratory findings in adults with moderate-to-severe AD treated with dupilumab up to 3 years.

Methods: LIBERTY AD OLE (NCT01949311) was a phase 3, multicenter, open-label extension study in adults with moderate-to-severe AD receiving dupilumab 300 mg weekly.

Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis.

Background: Dupilumab has demonstrated efficacy with acceptable safety in clinical trials in patients with moderate to severe atopic dermatitis (AD).

Objective: To assess dupilumab's impact on asthma and sinonasal conditions in adult patients with moderate to severe AD in four randomized, double-blinded, placebo-controlled trials.

Methods: In LIBERTY AD SOLO 1 (NCT02277743), SOLO 2 (NCT02755649), CHRONOS (NCT02260986), and CAFÉ (NCT02755649), patients received placebo, dupilumab 300 mg every 2 weeks (q2w), or dupilumab 300 mg weekly (qw).

Absence of Excess Intra-Individual Variability in Retinal Function in People With Schizophrenia.

People with schizophrenia exhibit increased intra-individual variability in both behavioral and neural signatures of cognition. Examination of intra-individual variability may uncover a unique functionally relevant aspect of impairment that is not captured by typical between-group comparisons of mean or median values. We and others have observed that retinal activity measured using electroretinography (ERG) is significantly reduced in people with schizophrenia; however, it is currently unclear whether greater intra-individual variability in the retinal response can also be observed.

Preoperative measurement of the thickness of the center of the humeral head predicts screw cutout after locked plating of proximal humeral fractures.

Hypothesis And Background: Preoperative computed tomography (CT) scans can be used to measure the thickness of the center of the humeral head to identify patients at a higher risk of screw cutout after open reduction-internal fixation.

Methods: At an academic medical center, we performed a retrospective review of all patients aged ≥ 18 years who had sustained a proximal humeral fracture that was treated with open reduction-internal fixation between January 1, 2005, and December 31, 2014, and who underwent preoperative shoulder CT. Ninety-four patients were included.

Clinical trial design in phase 2 and 3 trials for pulmonary hypertension.

This article on clinical trial design incorporates the broad experience of members of the Pulmonary Vascular Research Institute's (PVRI) Innovative Drug Development Initiative (IDDI) as an open debate platform for academia, the pharmaceutical industry and regulatory experts surrounding the future design of clinical trials in pulmonary hypertension. It is increasingly clear that the design of phase 2 and 3 trials in pulmonary hypertension will have to diversify from the traditional randomised double-blind design, given the anticipated need to trial novel therapeutic approaches in the immediate future. This article reviews a wide range of differing approaches and places these into context within the field of pulmonary hypertension.

Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington's Disease Patients-A Randomized Phase 2 Clinical Trial.

SRX246 is a vasopressin (AVP) 1a receptor antagonist that crosses the blood-brain barrier. It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials. The present study was a 3-arm, multicenter, randomized, placebo-controlled, double-blind, 12-week, dose escalation study of SRX246 in early symptomatic Huntington's disease (HD) patients with irritability.

Decisional involvement and information preferences of patients with hematologic malignancies.

Understanding decisional involvement and information preferences in patients with hematologic malignancies may help to optimize physician-patient communication about treatment decisions and align the decision-making processes with patients' preferences. We described and examined factors associated with preferences of patients with hematologic malignancies for decisional involvement, information sources, and presentation of information. In a multicenter observational study, we recruited 216 patients with hematologic malignancies of any stage from September 2003 to June 2007.