Assessing the Impact of a Designated Pharmacist Intervention on Drug Treatment Costs and Technical Efficiency in the Hemato-Oncology Outpatient Clinic.

Objectives: This study aimed to investigate the impact of a designated pharmacist (DPha) intervention in a hemato-oncology unit, focusing on reducing drug treatment costs and improving technical efficiency (TE).

Methods: Data from an 8-month intervention in the Israeli Clalit Health Services hemato-oncology outpatient unit were analyzed. During the study, the DPha reviewed the drug therapies being administered.

Phase 1 study of JNJ-64619178, a protein arginine methyltransferase 5 inhibitor, in patients with lower-risk myelodysplastic syndromes.

Splicing factor (SF) gene mutations are frequent in myelodysplastic syndromes (MDS), and agents that modulate RNA splicing are hypothesized to provide clinical benefit. JNJ-64619178, a protein arginine methyltransferase 5 (PRMT5) inhibitor, was evaluated in patients with lower-risk (LR) MDS in a multi-part, Phase 1, multicenter study. The objectives were to determine a tolerable dose and to characterize safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.

Phase 3 SELENE study: ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma.

The phase 3 SELENE study evaluated ibrutinib + chemoimmunotherapy (CIT; bendamustine and rituximab [BR]; or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for patients with relapsed/refractory (R/R) follicular lymphoma (FL) or marginal zone lymphoma (MZL). Adult patients who had received ≥1 prior line of CIT were randomized 1:1 to oral ibrutinib (560 mg) or placebo daily, plus 6 cycles of BR/R-CHOP. The primary end point was investigator-assessed progression-free survival (PFS).

Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Advanced Solid Tumors.

Purpose: In this first-in-human, Phase 1, open-label, multicenter study, we evaluated JNJ-64619178, a selective and potent PRMT5 inhibitor, in patients with advanced malignant solid tumors or non-Hodgkin lymphomas (NHL). The primary objective was to evaluate the safety and to identify a recommended Phase 2 dose (RP2D) of JNJ-64619178.

Patients And Methods: Adult patients with treatment-refractory advanced solid tumors or NHL and measurable disease received escalating doses of JNJ-64619178 following two schedules (Schedule A: 14 days on/7 days off; Schedule B: every day on a 21-day cycle).

[The German Association for Foot and Ankle (D.A.F.) registry on treatment of end-stage total ankle arthritis-what is its clinical impact?].

Initially established as a voluntary prosthesis register for total ankle replacement, the registry now enables analysis of revisions, complications, and clinical and functional outcomes-including patient-reported outcome measures-based on a period spanning more than 10 years. To allow analyses of the outcomes of ankle arthrodesis and supramalleolar osteotomies for treatment of end-stage arthritis in the future, the registry was extended by structured capturing of these procedures in 2018. While descriptive and analytical statistical evaluations of total ankle replacement are already possible today, the number of datasets on arthrodesis and supramalleolar osteotomies is still too small to support these analyses or comparative evaluations.

Association between PCV13 pneumococcal vaccination and risk of hospital admissions due to pneumonia or sepsis among patients with haematological malignancies: a single-centre retrospective cohort study in Israel.

Objectives: Patients with haematological malignancies receiving immunosuppressive therapy are at highest risk of invasive pneumococcal disease. Our goal was to investigate whether vaccination of haematological patients with pneumococcal 13-valent conjugated vaccine (PCV13) prior to therapy initiation is associated with decreased hospital admissions due to pneumonia or sepsis within 12 months.

Design And Setting: A longitudinal retrospective cohort study was conducted at the haematology unit of Carmel Medical Center, Israel.

Adherence with direct oral anticoagulants in patients with atrial fibrillation: Trends, risk factors, and outcomes.

Background: Adherence to direct oral anticoagulants (DOACs) remains a concern among non-valvular atrial fibrillation (AF) patients. We aimed to assess patterns of adherence with DOACs and examine their association with ischemic stroke and systemic embolism (SE).

Methods: This retrospective cohort study includes all adult members of Clalit Health Services, the largest healthcare provider in Israel, with newly diagnosed non-valvular AF between January 2014 and March 2019, who initiated DOACs within 90 days of AF diagnosis and used DOACs exclusively.

Novel mutation in coagulation factor VII (Carmel mutation): Identification and characterization.

Background: Measurement of factor VII (FVII) activity does not enable prediction of bleeding tendency in individuals with inherited FVII deficiency.

Objective: To characterize the molecular and functional features of FVII in a family with FVII deficiency and correlate them with the bleeding tendency.

Patients/methods: We studied 7 family members with very low FVII activity using prothrombin time (PT), activated factor VII (FVIIa), FVII activity level, and thrombin generation.

Implementation of oral anticoagulation treatment guidelines in patients with newly diagnosed atrial fibrillation.

Aims: Oral anticoagulants (OACs) are considered the mainstay in preventing stroke in atrial fibrillation (AF). OAC treatment remains suboptimal among AF patients, even after the introduction of direct oral anticoagulants (DOACs). We aimed to assess trends overtime and current implementation of OAC treatment guidelines in AF, using a large dataset of real world data from Israel.

Willingness and concerns of transfusion-dependent hematological patients toward the option of home transfusion therapy.

Background: One of the main obstacles of providing home-based palliative care to transfusion-dependent hematology patients is the lack of home transfusions services. While healthcare professionals are concerned with safety and cost of home transfusions, the attitude of the patients toward home transfusions are mostly unknown.

Aim: To obtain quantitative data regarding the willingness and concerns of transfusion-dependent patients with hematological diseases toward the option of home transfusions.

Otoendoscopy in the Office and Operating Room.

Since its introduction into the field of otology in 1967 endoscopes are gaining acceptance in evaluation and treatment of middle ear disease. Endoscopes offer a wide field view enabling looking "around the corner" with reduced need for soft tissue and bone removal. Outcomes of middle ear surgery for cholesteatoma and need for second-look procedures are improving because of the addition of endoscopic evaluation.

Approach bias modification training to increase physical activity: A pilot randomized controlled trial in healthy volunteers.

Regular physical activity is associated with better physical and mental health outcomes as well as higher quality of life. This pilot randomized controlled trial examined whether approach bias modification, an economical and easily accessible computerized cognitive training, could increase objectively and subjectively measured physical activity in individuals aiming for more physical activity. Forty healthy volunteers of normal weight were randomly allocated to six sessions of approach bias modification or no treatment.

Improving emotion recognition in anorexia nervosa: An experimental proof-of-concept study.

Objective: Previous research has found increasing evidence for difficulties in emotion recognition ability (ERA) and social cognition in anorexia nervosa (AN), and recent models consider these factors to contribute to the development and maintenance of the disorder. However, there is a lack of experimental studies testing this hypothesis. Therefore, the present proof-of-concept study examined whether ERA can be improved by a single session of a computerized training in AN, and whether this has short-term effects on eating disorder symptoms.

Preoperative direct oral anticoagulants treatment and all-cause mortality in elderly patients with hip fracture: A retrospective cohort study.

Introduction: Hip fracture is common among the elderly and is associated with increased morbidity and mortality, particularly when surgery is delayed. Direct oral anticoagulants (DOACs) use might increase bleeding and postpone hip repair surgery. We aimed to assess the association between preoperative DOACs use and adverse outcomes in elderly patients with hip fracture.

Association between myelofibrosis and risk of non-hematologic malignancies: a population-based retrospective cohort study.

Controversy regarding the risk of non-hematologic malignancies in myelofibrosis patients still exists. We aimed to examine the association between myelofibrosis and non-hematologic malignancies. A cohort of 1,469,790 adults without a diagnosis of myelofibrosis was identified on 1 January 2007, from the electronic medical records of the largest healthcare provider in Israel.

Association between myelofibrosis and thromboembolism: A population-based retrospective cohort study.

Background: The risk of thromboembolism in myelofibrosis remains incompletely understood.

Objectives: To examine the association between myelofibrosis and each of venous and arterial thromboembolism.

Methods: A cohort of 1 469 790 adults without a diagnosis of myelofibrosis was identified on 1 January 2007, from the electronic medical records of the largest health-care provider in Israel.

Dissolution testing of oral film preparations: Experimental comparison of compendial and non-compendial methods.

In vitro dissolution testing is one of the most frequently used tests in pharmaceutical quality control, since evaluation of the drug release profile and estimation of the dosage form performance is enabled. However, for oral film preparations no standardized compendial dissolution method or specifications are available worldwide. Therefore, four different dissolution methods described in the literature, namely the basket method, the paddle and glass disc (PGD) method, the flow-through cell with adapted film sample holders produced via 3D printing (FTC + FH3D) and the "Punch and Filter" (PAF) method were chosen and their suitability to investigate oral films with different release properties was compared.

3D-Printed Isoniazid Tablets for the Treatment and Prevention of Tuberculosis-Personalized Dosing and Drug Release.

The aim of the present work was to produce 3D-printed oral dosage forms with a sufficient drug dose displaying various release profiles. Hot-melt extrusion was utilized to produce drug-loaded feedstock material that was subsequently 3D-printed into 6, 8, and 10 × 2.5 mm tablets with 15% and 90% infill levels.

Novel Dissolution Method for Oral Film Preparations with Modified Release Properties.

Oromucosal film preparations have gained popularity in pharmaceutical research and development. Therefore, oral films have been integrated into the monograph "oromucosal preparations" of the European Pharmacopeia in 2012. Regulatory authorities explicitly demand dissolution studies for films, but neither refer to suitable methods nor established specifications.

Prolonged release from orodispersible films by incorporation of diclofenac-loaded micropellets.

Prolonged drug release provided by multiple-unit dosage forms is highly beneficial to enhance the compliance and safety of the pharmacotherapy even for patients with swallowing deficiencies. To facilitate the intake for these patients, multiple-unit tablets and capsules have to be crushed or opened. An attempt to overcome these issues has been made by the introduction of orodispersible films (ODFs), which rapidly disintegrate within the oral cavity and facilitate the intake of oral solid dosage forms.