ASIDE Journals (American Society for Inclusion, Diversity, and Equity in Healthcare)
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Environmental Monitoring in a Class D Pharmaceutical Facility: Microbial Load and Hygiene Practices, a Risk-Based Cross-Sectional Study
Get PDFBackground: Environmental monitoring is a crucial current Good Manufacturing Practice (cGMP) tool for assessing the status of the working environment in a Pharmaceutical Manufacturing Facility.
Methods: The test was conducted between May 20 and 25, 2025. 90 mm Diameter Settle Plates methods, 4 hours exposure under dynamic conditions, were used as a test method to study the microbial load in controlled and classified areas. The finger dab test was used to assess hygiene and sanitization practices in the plant. The non-viable count was excluded from the study due to limitations, including a lack of facilities for conducting the tests.
Result: The result of the environmental monitoring test was below 100 colony-forming units (CFU) in the rooms. The mean value of Total Aerobic Microbial Count and Total Yeast and Mold Count shows a higher microbial count at the Near Return air loop. The p-value of Total aerobic microbial count and Total Yeast and Mold Count was found to be 0.8685 and 0.8716, respectively. The result is not significant at p<0.05. The result of the Finger dab test was below 100 CFU/5 fingerprints in both hands and complies with the internal action limit.
Conclusion: The result of the study suggests that the higher load of organisms was found at the “near return loop area”. The result of the Finger dab test was satisfactory according to the in-house limit (100 CFU). The result can serve as a basis for selecting a sample spot for regular Environmental Monitoring in a Manufacturing Facility
Epidemiological Patterns of Diabetes Mellitus in The United States of America: An Observational Multicenter Analysis From 1990 to 2024
Get PDFIntroduction: Diabetes mellitus represents a significant public health challenge, however, the current trends in its epidemiology remain incompletely characterized. This study aimed to analyze epidemiological changes and demographic patterns in diabetes incidence and prevalence across the United States from 1990 to 2024.
Methods: We conducted a retrospective cohort study utilizing the TriNetX Global Health Research Network, analyzing de-identified electronic health records from 52,922,301 patients across 92 U.S. healthcare organizations. Time-based changes in disease trends regarding diabetes incidence and prevalence were targeted, and stratified by age, sex, race, and diabetes type.
Results: Combined diabetes incidence increased from 3.98 per 1,000 in 1990-1994 to 60.98 per 1,000 in 2020-2024, while prevalence doubled from 6.26% to 12.00%. T2DM showed a twenty-fold increase in incidence (3.52 to 59.30 per 1,000), while T1DM peaked at 7.46 per 1,000 in 2010-2014 before declining to 4.59 per 1,000. Significant disparities were observed across demographic groups, with the highest rates among Native Hawaiians/Pacific Islanders (incidence: 94.75 per 1,000; prevalence: 20.65%) and consistent male predominance (incidence: 69.40 vs 54.07 per 1,000).
Conclusions: These findings reveal concerning trends in diabetes epidemiology, characterized by a prominent and significant elevation in disease burden and persistent demographic disparities. The results call for the urgent need for optimized preventive strategies, targeted interventions for high-risk populations, and systematic changes in healthcare delivery to address this growing public health challenge effectively
Mycophenolate Mofetil Use for Inflammatory Bowel Disease
Get PDFMycophenolate Mofetil (MMF) is a prodrug that gets converted to mycophenolic acid (MPA). MPA inhibits the Akt/mTOR and STAT5 pathways and has a reversible cytostatic effect on T and B lymphocytes [1].
MMF is FDA-approved for immunosuppressive therapy after solid organ transplantation. MMF has been used for multiple inflammatory/autoimmune conditions including psoriasis, dermatomyositis, autoimmune hepatitis, lupus erythematosus, myasthenia gravis, and Takayasu arteritis [2].
In this Editorial, we discuss the recently published systematic review and meta-analysis by Balassiano et al [3]. This systematic review and meta-analysis studied the use of MMF for the treatment of IBD patients. This review included both retrospective studies, case series, and clinical trials that evaluated the use of MMF in patients with IBD. Included patients were intolerant or unresponsive to Azathioprine. MMF was used in the included studies for induction and maintenance of remission, or as a steroid sparing agent/immunomodulator. This study demonstrated MMF’s efficacy in both induction and maintenance of remission in IBD patients. MMF was associated with added benefits for patients on steroids as well as those on anti-TNF therapy [3].
MMF has several boxed warnings in the United States, limiting its use outside FDA-approved indications. MMF should be prescribed only by healthcare providers experienced in immunosuppressive therapy and organ transplant management, with access to comprehensive laboratory and medical resources [4].
There is also a significant risk of infections associated with immunosuppression including but not limited to opportunistic infections, which may result in significant morbidity and mortality. MMF use is associated with an increased risk of malignancy including but not limited to lymphoma and skin cancers. There is also a boxed warning suggesting avoiding MMF use in pregnancy if alternative therapies are available as its use is associated with congenital malformation and first-trimester pregnancy loss [5].
MMF has been associated with endoscopic findings that could be similar to acute colitis, IBD, ischemia, and graft-versus-host disease. Development of such side effects or endoscopic findings can lead to discontinuation of treatment, treatment interruption, or medication non-compliance [6, 7].
In this study, the pooled event rate for adverse events was 26.1% (20.3%-32.8%). The side effect profile is crucial in determining the role of MMF in IBD treatment. The IBD field is evolving around a patient-centered approach when it comes to therapeutic selection. IBDologists extensively discuss potential side effects and explore the patient’s risk appetite. In general, more than one in four is considered a relatively high risk.
While side effects could constitute a major challenge for MMF use in IBD patients, their impact on treatment adherence, disease progression, and quality of life must be carefully weighed against MMF’s potential benefits. The development of side effects has been associated with specific risk factors that increase the risk of developing side effects which could open the door for drug adjustment and close monitoring that might allow its use. These risk factors include using a non-enteric coated formulation, increased MMF blood levels, concomitant use of other immunosuppressant agents like calcineurin inhibitors, and female sex [8-11].
MMF is relatively inexpensive compared to other IBD therapies. A dose price can be as low as 129.57 for an IV dose. This is cheaper compared to Azathioprine prices [12]. With the evolving widespread use of biosimilars, we are heading to an era with better accessibility to advanced IBD therapies and this will allow gastroenterologists to adopt the recommended top-down approach in therapeutic selection [13].
The ACG guidelines for Crohn’s disease recommend combining an immunomodulator with anti-TNF rather than using anti-TNF alone [14]. Hernandez-Camba et al. showed added benefits of anti-TNF when combined with MMF [15]. This suggests potential benefits of MMF as an immunomodulator that could decrease anti-TNF immunogenicity and decrease the risk of secondary non-response.
The study has some significant limitations. The included studies had heterogeneous designs. The study lacked a control group and did not compare MMF to alternatives such as Azathioprine or Mercaptopurine.
The IBD therapies are expanding and it’s an evolving field with multiple advancements annually. Selection of therapy in patients with IBD is a multi-step and complex process that involves close consideration of the disease stage, patient population, disease complications, medication history, prognostic factors, presence of extra-intestinal manifestations of IBD, potential side effects of medications, patients’ preferences and cost implications [14].
In conclusion, this study highlights the potential benefits of MMF as a steroid-sparing agent or as an immunomodulator in conjunction with ant-TNF. It provides evidence for the use of MMF as an alternative for those intolerant or unresponsive to Azathioprine and Methotrexate
Rare Case of Disseminated Nocardiosis with Simultaneous Lung, Brain, and Spinal Cord Involvement in a Patient with Sarcoidosis
Get PDFNocardiosis is an uncommon opportunistic infection commonly affecting the lungs in immunocompromised individuals. We present an unusual case of disseminated nocardiosis involving the spinal cord and brain in a patient previously diagnosed with sarcoidosis and treated with glucocorticoids. We are presenting the case of a 46-year-old Caucasian male with sarcoidosis who develops pulmonary nocardiosis, with chest X-ray (CXR) revealing left lower lobe infiltrates diagnosed as community-acquired pneumonia usually caused by Nocardia, confirmed by excisional biopsy. A few days later, the disease progressed to the spinal cord, leading to an epidural abscess, and disseminated to the brain, leading to multiple ring-enhancing lesions confirmed by MR. Timely surgical intervention, such as abscess drainage, is crucial in the management of abscesses to prevent life-threatening complications and preserve neurological function. Clinicians should maintain a broad differential diagnosis when evaluating new pulmonary infiltrates in patients with sarcoidosis. Early CNS imaging should be considered in cases of severe pulmonary nocardiosis to prevent catastrophic complications
Concurrent Diabetic Ketoacidosis and Acute Coronary Syndrome: A Systematic Review of Case Reports
Get PDFBackground: Diabetic ketoacidosis (DKA) and acute coronary syndrome (ACS) represent serious medical emergencies with a complex bidirectional relationship. The clinical presentations and outcomes of these conditions when they co-occur remain incompletely characterized in the literature. We aim to investigate this correlation.
Methods: We systematically searched the PubMed, Scopus, and Web of Science databases, using terms related to acute coronary syndrome (including myocardial infarction, unstable angina, STEMI, and NSTEMI) combined with diabetic ketoacidosis terms, from inception to April 2025, for case reports. The CARE checklist was applied to assess the risk of bias in the included reports.
Results: Twenty-one case reports met inclusion criteria, describing 11 males and 9 females (one unspecified) with a mean age of 51 years. Patients had both type 1 (42.8%) and type 2 (57.1%) diabetes mellitus. Chest pain was the most common presenting symptom (52.3%), but was absent in nearly half of the cases. Six patients (28.5%) on sodium-glucose cotransporter-2 (SGLT2) inhibitors presented with euglycemic DKA. ST-segment elevation was observed in 61.9% of patients, while five patients had normal coronary arteries despite elevated troponin levels. All patients survived after receiving standard DKA management and appropriate cardiac interventions.
Conclusion: This systematic review highlights the importance of maintaining high clinical suspicion for concurrent DKA and ACS, even when typical symptoms such as chest pain or hyperglycemia are absent. We recommend routine cardiac evaluation, including ECG, troponin assessment, and echocardiography, for all DKA patients to ensure early recognition and appropriate management of these potentially life-threatening conditions
Epidemiological Assessment of Risk Factors for Inguinal Hernia Among Male Patients in Iraq: A Case-Control Study
Get PDFIntroduction: Inguinal hernia is one of the most common surgical conditions, particularly among males. Despite its prevalence, limited regional data exist on the associated risk factors in Iraq. This study aimed to identify socio-demographic, lifestyle, and clinical risk factors contributing to inguinal hernia among male patients.
Methods: A case-control study was conducted on 250 male patients diagnosed with inguinal hernia at multiple public hospitals and surgical clinics across three major cities in Iraq: Wasit, Baghdad, and Basra. Compared with a 250-member control group. Data were collected using structured questionnaires covering socio-demographic details, occupational exposure, lifestyle habits, medical history, and family history. Univariate and logistic regression analyses were performed to identify significant risk factors.
Results: Most patients (57.5%) were between 41 and 60 years old. Heavy lifting (63.6%), smoking(62.0%), chronic cough (38.6%), and constipation (32.4%) were frequently reported. A positive family history was noted in 22.4% of cases. Univariate analysis revealed significant associations between inguinal hernia and heavy lifting (p < 0.001), smoking (p < 0.001), chronic cough (p = 0.002), constipation (p = 0.020), and a family history of inguinal hernia (p = 0.001). Logistic regression confirmed heavy lifting (OR=2.78), family history (OR=2.46), smoking (OR=1.69), and chronic cough (OR=1.54) as independent risk factors.
Conclusion: Heavy lifting, smoking, chronic cough, and family history were significantly associated with increased risk of inguinal hernia among Iraqi males. Public health strategies that focus on prevention, early identification, and lifestyle modification are essential for reducing the incidence and recurrence of this condition
A Hidden Cause of Bone Fragility: Late Diagnosis of Hypophosphatasia in a 40-Year-Old Female
Get PDFHypophosphatasia (HPP) is a rare inherited metabolic disorder caused by loss-of-function mutations in the ALPL gene, leading to deficient activity of tissue-nonspecific alkaline phosphatase (TNSALP). This results in impaired bone and dental mineralization, causing a wide range of clinical manifestations, from perinatal lethality to mild adult-onset forms. We report a case of a 40-year-old female with a history of joint pain, multiple fractures, dental issues, and bipolar disorder, who was diagnosed with adult-onset HPP. Laboratory investigations revealed persistently low alkaline phosphatase (ALP) levels and elevated vitamin B6. Genetic testing confirmed a pathogenic ALPL mutation. The patient was initiated on enzyme replacement therapy (ERT) with asfotase alfa, resulting in significant symptom improvement. This case highlights the importance of recognizing HPP in adults with unexplained musculoskeletal symptoms and underscores the role of genetic testing in the diagnosis and management of this condition
Bone Marrow Necrosis in A Male Patient with Anti-Phospholipid Syndrome: A Case Report with Literature Review
Get PDFAnti-phospholipid syndrome (APS) is a systemic autoimmune disease causing arterial and venous thrombosis, leading to macrovascular and microvascular complications. Bone marrow necrosis (BMN) is defined as the death of hematopoietic tissue and the loss of fat cells in a bone marrow biopsy. BMN is typically associated with a poor prognosis, with most patients dying within weeks. We present a case of BMN in a 32-year-old male patient with APS admitted to our hospital. The patient presented with bilateral non-healing leg ulcers and bilateral lower limb edema. The findings of the duplex ultrasound were consistent with old bilateral deep vein thromboses in the calves. The presence of acute kidney injury and proteinuria prompted a renal biopsy, which revealed chronic thrombotic microangiopathy. Bone marrow biopsy revealed BMN. Unfortunately, the patient did not respond to immunosuppressive treatment and passed away due to septic shock. The unique features in the patient’s presentation, combined with the availability of extensive data on the patient’s history and investigations, further enhance its significance. It is not possible to establish a cause-and-effect relationship or draw conclusive findings from this case report alone. More case reports from clinicians who come across BMN in patients with APS are needed to broaden our understanding of the pathogenesis, presentation, management, and outcomes
Search Filters to Identify Automation in HEOR: An Umbrella Review of Performance and Overlap
Get PDFBackground: Search strategies used to identify evidence on automation in Health Economics and Outcomes Research (HEOR) often lack sensitivity and specificity, resulting in information overload or missed studies. This umbrella review evaluated and compared the performance and overlap of search filters commonly used to retrieve automation-related HEOR evidence.
Methods: Systematic literature reviews (SLRs) and search filters focusing on any form of automation in HEOR were included. Searches (January 01, 2023–July 03, 2024) were conducted in EMBASE, ISSG Resource, and Google Scholar. Subject headings, search terms, and performance metrics were extracted. Reference lists were cross-checked. Screening was performed by one reviewer, with 20% verified by a second reviewer. The PRESS checklist was used to assess search strategy quality. The protocol was registered with the Open Science Framework (OSF).
Results: Seven SLRs and one standalone filter, reporting 11 search strategies, met the inclusion criteria. HEOR relevance was defined by studies applying search filters in contexts of SLRs, indirect treatment comparisons, and economic modeling. Included SLRs retrieved between 5-273 studies. PubMed was the most frequently searched database. Commonly used subject headings included “artificial intelligence,” “deep learning,” “machine learning,” and “natural language processing,” with “artificial intelligence” the most frequent free-text term. Inclusion rates varied: title/abstract (1%–8%), full-text (27%–86%), and final inclusion (0.13%–2.31%). Time to include one study ranged from 0.6-8 hours.
Conclusions: Considerable variability in search filter performance was observed, causing lower specificity and inefficient evidence retrieval. Standardized, high-performing search strategies are needed to enhance efficiency and reliability in identifying automation-related HEOR evidence
Aqueous Basella alba Mitigates Cyclosporine-Induced Nephrotoxicity in Wistar Rats: Relevance in Adjuvant Therapy
Get PDFIntroduction: Cyclosporine A (CsA) is an immunosuppressant agent that is usually considered as a first-line therapy against organ rejection after a transplant procedure. However, its administration is often associated with nephrotoxicity and a compromise of kidney function. There is a paucity of literature on the effects of aqueous Basella alba leaf extract (ABALE) in this condition. This study aimed to bridge the knowledge gap.
Methods: Thirty male Wistar rats were divided into 6 groups of 5 rats each, such that the experimental groups received graded doses of ABALE at 100mg/kg, 200mg/kg, and 400mg/kg for 21 consecutive days, after inducing nephrotocity with CsA at 20mg/kg/day (i.p).
Results: Treatment with ABALE resulted in a dose-dependent reduction of oxidative stress, inflammation, and elevated plasma markers of kidney dysfunction, with the highest dose showing the greatest protective effect (p < 0.05). Histological analysis of the kidneys also revealed near-normal architecture following ABALE treatment, while CsA administration was associated with marked vacuolation of the kidney interstitium and glomerular atrophy. However, no significant difference was observed between the untreated recovery group and the nephrotoxicity model group.
Conclusion: ABALE mitigated cyclosporine-induced nephrotoxicity by suppressing plasma pro-inflammatory cytokines and restoring antioxidant balance. These findings suggest that the extract may serve as a promising adjuvant therapy in CsA-induced nephrotoxicity