Stability of Allopurinol in Extemporaneously Compounded Oral Suspensions with Oral Mix and Oral Mix SF.

Allopurinol is a xanthine oxidase inhibitor used to reduce the production of uric acid in the body. Commercial tablets may be crushed and suspended in a compounding vehicle and provide an alternative dosage form for patients with difficulty swallowing, such as children. The stability of a compounded preparation of allopurinol 20 mg/mL was evaluated in ready-to-use vehicles, namely Oral Mix and Oral Mix SF.

A novel model of care for paediatric patients with developmental disabilities and associated behaviours of concern.

Aim: Children and adolescents with autism spectrum disorder and/or intellectual disability often present to emergency departments with behaviours of concern: irritability, aggression and self-injurious behaviour. The objective of this study was to design, implement and evaluate a new model of care to support these patients and their families following presentation to reduce the need for re-presentation.

Methods: We designed and evaluated a new model of care for these patients, comprising consultations with a developmental paediatrician and a child psychiatrist, referral to a specialist behavioural service and 6 weeks of care coordination by a clinical nurse consultant.

Feasibility and Clinical Utility of Patient-Reported Outcome Measurement Information System-29 in a Newly Established Adolescent and Young Adult Oncology Program.

Despite improvements in survival, adolescent and young adult (AYA) oncology patients are at high risk for experiencing negative health-related quality of life (HRQOL) outcomes. AYA cancer programs have attempted to develop assessment tools to identify areas of need. We aimed to demonstrate the feasibility/utility of the Patient-Reported Outcome Measurement Information System-29 (PROMIS-29) within an AYA oncology program clinic.

Case Report on the Effect of AlpaWash® on the Healing of a Post-surgical Wound in a Female Canine Initially Diagnosed with Pyometra.

Pyometra is a common disease in intact female canines characterized by an infection of the uterus. If it is not treated immediately, it could result in various complications such as fistulous tract development, sepsis, hemorrhage, uveitis, conjunctivitis, pyelonephritis, urinary tract infection, and myocarditis. In this case report, we highlight the benefits of the application of a topical ointment on wound healing after ovariohysterectomy in canine Pyometra.

Bracketed Stability Evaluation of Methimazole USP in PLO Gel Mediflo™30 Pre-Mixed.

Extemporaneously compounded Methimazole 1% and 10% in PLO Gel Mediflo™30 Pre-Mixed were studied to assess physical, chemical and microbial stability over time. The formulations were stored at room temperature in tightly closed, light resistant plastic containers. Chemical stability was evaluated using a validated, stability indicating HPLC analysis and physical stability was evaluated through observation of organoleptic appearance and pH measurement at predetermined time points.

ASCT2-Targeting Antibody-Drug Conjugate MEDI7247 in Adult Patients with Relapsed/Refractory Hematological Malignancies: A First-in-Human, Phase 1 Study.

Background: MEDI7247 is a first-in-class antibody-drug conjugate (ADC) consisting of an anti-sodium-dependent alanine-serine-cysteine transporter 2 antibody-conjugated to a pyrrolobenzodiazepine dimer.

Objective: This first-in-human phase 1 trial evaluated MEDI7247 in patients with hematological malignancies.

Patients And Methods: Adults with acute myeloid leukemia (AML), multiple myeloma (MM), or diffuse large B-cell lymphoma (DLBCL) relapsed or refractory (R/R) to standard therapies, or for whom no standard therapy exists, were eligible.

Stability Evaluation of Bracketed Diclofenac Sodium USP in VersaPro™ Cream Base, VersaPro™ Gel Base and PLO Gel Mediflo™ 30 Compound Kit.

Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been found to be effective in treating a variety of acute and chronic pain and inflammatory conditions. A stability study was designed to assess the physical, chemical, and antimicrobial stability of three extemporaneously compounded bracketed Diclofenac Sodium formulations over time using a validated, stability indicating HPLC method. Diclofenac Sodium 1% and 15% were compounded in Medisca VersaPro™ Cream Base, VersaPro™ Gel Base and PLO Gel Mediflo™30 Compound Kit and stored at room temperature, in tightly closed, light resistant, plastic containers for 180 days.

Highlighting the Benefits of AlpaWash in Wound Care: Case Reports in Small Animals.

Several studies have reported the potential of utilizing natural extracts in wound care, emphasizing those with anti-inflammatory and antimicrobial properties. In veterinary medicine, dermal-lesion treatment can be very challenging considering the patient's compliance and awareness of their condition. In this article, six veterinary case reports have been presented to elucidate the advantages of AlpaWash, a topical application utilized in combination with the prescribed medications of the patients, for the purpose of addressing the process of wound healing in three cats and three dogs.

Case Report in Equine: Highlighting the Benefits of Medisca CopaSil in Burn Scar Management.

In this case report, we highlight the benefits of Medisca CopaSil application for scar healing in a horse having sustained second-degree burn injuries covering most of its back. The application of CopaSil started three months after sustaining the burn injury when silver sulfadiazine topical cream treatment showed no significant improvement. CopaSil is formulated with ingredients that may help in reducing inflammation and accelerate healing by modulating the immune response.

Patterns of presentation to a Children's Hospital Emergency Department of patients with autism and/or intellectual disability with behaviours of concern.

Background: The aim of this study was to investigate the demographic, clinical characteristics, and service systems of patients with autism spectrum disorder (ASD) and/or intellectual disability presenting to a large paediatric hospital emergency department (ED) with behaviours of concern (BOC) over a two-year period.

Method: Retrospective audit of ED presentations with BOC in patients with ASD and/or intellectual disability from 1 January 2019 to 31 December 2020, at the Royal Children's Hospital, Melbourne, Australia.

Results: There were 124 presentations (84 patients) in 2019 and 129 presentations (82 patients) in 2020.

Case Report of Anal Fissures and Hemorrhoids Treated with Compounded Cromolyn Sodium and Naltrexone Hydrochloride in MEDISCA's SPG SUPPOSI-BASE.

The purpose of this case report is to evaluate and demonstrate the benefits of compounded therapy in treating chronic rectal fissures with hemorrhoids using a compounded suppository containing cromolyn sodium and naltrexone hydrochloride in MEDISCA's SPG SUPPOSI-BASE. The primary outcomes of symptomatic improvement and healed fissure were reported and confirmed by the practitioner and, via self-assessment, by the patient, which was observed after a long-troubled history of failed treatments. The case had no side effects or complications, and the patient reported a full recovery after using this compounded therapy for ten days.

Analysis of Pharmacodynamics and Single-Agent Activity of CD3xCD123 Bispecific Antibody APVO436 in Relapsed/Refractory AML and MDS Resistant to HMA or Venetoclax Plus HMA.

APVO436 is a recombinant bispecific antibody designed to direct host cytotoxic T-cells to CD123-expressing blast cells in patients with hematologic malignancies. APVO436 showed promising tolerability and single-agent activity in relapsed or refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary purpose of this analysis was to evaluate the therapeutic and pharmacodynamic effects of APVO436 in 14 R/R AML/MDS patients who had failed treatment with hypomethylating agents (HMA) or venetoclax plus HMA prior to being enrolled in the APVO436 Phase 1 dose-escalation study that was recently completed.

Structural and Ultrastructural Analysis of the Multiple Myeloma Cell Niche and a Patient-Specific Model of Plasma Cell Dysfunction.

Multiple myeloma (MM) is a deadly, incurable malignancy in which antibody-secreting plasma cells (PCs) become neoplastic. Previous studies have shown that the PC niche plays a role cancer progression. Bone marrow (BM) cores from MM and a premalignant condition known as monoclonal gammopathy of unknown significance (MGUS) patients were analyzed with confocal and transmission electron microscopy.

Phase 1/2 study of intratumoral G100 (TLR4 agonist) with or without pembrolizumab in follicular lymphoma.

Intratumoral injection of G100, a toll-like receptor 4 (TLR4) agonist, was shown pre-clinically to stimulate anti-tumor immune responses and tumor regression. This open-label, multicenter, phase 1/2 trial evaluated the safety, tolerability, and preliminary efficacy of intratumoral G100 injections following localized low-dose radiation in patients with follicular lymphoma (ClinicalTrials.gov #NCT02501473).

Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436.

We evaluate the risk, characteristics and biomarkers of treatment-emergent cytokine release syndrome (CRS) in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who received APVO436 during the dose-escalation phase of a Phase 1B study (ClinicalTrials.gov, identifier: NCT03647800). Of four patients who developed Grade ≥ 3 CRS, two received steroid prophylaxis.

Strategy management in collaborative clinical research partnerships.

Purpose: Today's clinical trial partnerships frequently join multi-disciplinary investigators and stakeholders, from different countries and cultures, to conduct research with a broad array of goals. This diversity, while a strength, can also foster divergent views about priorities and what constitutes success, thereby posing challenges for management, operations, and evaluation. As a sponsor and partner in such collaborations, we seek to assist and support their development and implementation of sound research strategies, to optimize their efficiency, sustainability, and public health impact.

Prospective, Randomized, Double-Blind, Placebo-Controlled Study on Efficacy of Copaiba Oil in Silicone-Based Gel to Reduce Scar Formation.

Introduction: Scars are the end result of a biologic and natural process of wound repair after injury, surgery, acne, illness, burns, and infection. When skin is damaged, a fast and coordinated body response is triggered by four highly integrated and overlapping phases including homeostasis, inflammation, proliferation, and tissue remodeling. Healing of a skin wound may result in an abnormal scar if the balance among these four phases is lost during the healing process.

A Clinical Phase 1B Study of the CD3xCD123 Bispecific Antibody APVO436 in Patients with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome.

APVO436 is a recombinant T cell-engaging humanized bispecific antibody designed to redirect host T cell cytotoxicity in an MHC-independent manner to CD123-expressing blast cells from patients with hematologic malignancies and has exhibited single-agent anti-leukemia activity in murine xenograft models of acute myeloid leukemia (AML). In this first-in-human (FIH) multicenter phase 1B study, we sought to determine the safety and tolerability of APVO436 in R/R AML/myelodysplastic syndrome (MDS) patients and identify a clinically active recommended phase 2 dose (RP2D) level for its further clinical development. A total of 46 R/R AML/MDS patients who had failed 1-8 prior lines of therapy received APVO436 as weekly intravenous (IV) infusions at 10 different dose levels, ranging from a Minimum Anticipated Biological Effect Level (MABEL) of 0.

A Phase II Study of Durvalumab in Combination with Tremelimumab in Patients with Rare Cancers.

Lessons Learned: Disease control with signals of response were demonstrated, which should lead to future validating clinical trials using checkpoint inhibitors in this underserved rare malignancy population. Although the study of single types of rare cancers is practically challenging, clinical trial designs that aggregate such patients into cohorts treated similarly are feasible, even in the community setting.

Background: Patients with rare cancers are an underserved population with limited access to clinical trials aside from phase I trials in the refractory setting.

The tetraspanin Tspan15 is an essential subunit of an ADAM10 scissor complex.

A disintegrin and metalloprotease 10 (ADAM10) is a transmembrane protein essential for embryonic development, and its dysregulation underlies disorders such as cancer, Alzheimer's disease, and inflammation. ADAM10 is a "molecular scissor" that proteolytically cleaves the extracellular region from >100 substrates, including Notch, amyloid precursor protein, cadherins, growth factors, and chemokines. ADAM10 has been recently proposed to function as six distinct scissors with different substrates, depending on its association with one of six regulatory tetraspanins, termed TspanC8s.

Heart failure as interstitial cancer: emergence of a malignant fibroblast phenotype.

A prolonged state of left ventricular pressure overload, commonly caused by hypertension and aortic valve disease, promotes remodelling of the myocardium that can progress to heart failure with preserved ejection fraction (HFpEF). In animal models, a major factor driving progression from pressure-overload hypertrophy (POH) to HFpEF is the activation and proliferation of an abnormal fibroblast phenotype that is resistant to apoptosis, degrades normal stromal matrix and is replaced with a fibrotic matrix structure. A similar fibroblast phenotype has been identified in the stroma of solid cancers.

Politics trumps policy: How health ministers make decisions.

This paper explores how health ministers make decisions. It is not intended to be an exhaustive inquiry into the subject; rather it draws on my personal experience as a public servant, a health minister, and a political advisor in the British Columbia government over the past 40 years, plus informal interviews with former health ministers from different political parties.

Clinical Use of Anti-Xa Monitoring in Malignancy-Associated Thrombosis.

Introduction. Low molecular weight heparin (LMWH) is preferred for malignancy-associated venous thromboembolism (VTE). Many providers monitor LMWH with anti-Xa levels, despite little validation on correspondence with patient outcome.

The coagulopathy in acute promyelocytic leukaemia--what have we learned in the past twenty years.

Coagulopathy is a unique component of the pathology of acute promyelocytic leukaemia (APL). Though many causative factors have been elucidated, therapies to rectify the coagulopathy are far from being realised. Thrombotic and bleeding complications remain the major causes of early deaths.

Contemporary treatment of APL.

Acute promyelocytic leukemia (APL) is characterized by coagulopathy, leukopenic presentation and sensitivity to anthracyclines, all-trans retinoic acid (ATRA) and arsenic trioxide (ATO). For the last 25 years, APL has been treated with a combination of ATRA and chemotherapy for induction followed by consolidation and maintenance therapy. This general treatment approach has resulted in cure rates of 80-90 %.