Adult Female Patients Research Articles

Adult Onset of Pyruvate Dehydrogenase Deficiency Presenting with Dystonia and Chorea in Female Patient from India - A Very Rare Case

We reported a very rare case of pyruvate dehydrogenase complex E1α (PDHA1) gene deficiency presenting as cervical dystonia and chorea in an adult female patient from India. Patient was presented with a history of involuntary rhythmic repetitive movements of both hands, legs, and head, lips and stammering of speech with tilting of neck to one side along with orofacial dyskinetic movements since past 6 years and gait changes since past 4 years. Her symptoms were progressive in nature. Her physical examination and systemic examinations were normal. Neurological examinations suggestive of cervical dystonia with chorea form movements. Brain MRI investigations revealed marked atrophy of bilateral caudate nuclei and putamina. Patient had a familial history of father and second brother had mild hand tremors. Patient has been referred for whole exome sequencing. The exome data analysis identified a very rare and unusual heterozygous indel variant c.-20_-19delinsCT, (chrX:19344018_19344019delinsCT) in 5’UTR region of PDHA1 gene caused late phenotypic onset of cervical dystonia as major clinical manifestation of PDHA1 deficiency along with chorea form movement disorders at the age of 24 year. In conclusion, to the best of our literature knowledge this is the novel and unusual case of adult female patient wherein we are reporting a novel heterozygous indel variant c.-20_-19delinsCT, (chrX:19344018_19344019delinsCT) in 5’UTR region of PDHA1 gene responsible for PDHA1 deficiency presenting with cervical dystonia and chorea as major clinical manifestations. Hence, dystonia and chorea as major clinical manifestations of PDH deficiency could be considered in adult patients also rather than only in paediatric patients.

Correlation of HbA1c with red cell width distribution and other red cell indices in Type II diabetic females.

Objective: To assess the correlation of HbA1c with hemoglobin concentration, RWD, and other red cell indices in Type II diabetes mellitus female patients. Study Design: Cross-sectional study. Setting: Department of Physiology, Al Nafees Medical College, and Pakistan Institute of Medical Sciences, Islamabad. Period: January 2019 to December 2020. Material & Methods: The study included 70 adult female diabetic patients, adhering to International Diabetes Federation guidelines. Exclusion criteria encompassed uncontrolled diabetes, pregnancy, renal issues, cardiac failure, and hemoglobinopathies. Laboratory tests, such as Complete Blood Count and HbA1c measurements, were conducted. SPSS version 23 was used for statistical analysis, employing mean, standard deviation, and Pearson's correlation to assess relationships among HbA1c, hemoglobin, Red Cell Distribution Width (RDW), and other red cell parameters. Results: A total of 70 female patients with diagnosed Type II diabetes mellitus were included in our study with a mean age of 40.45±12.70 years. The Mean±SD of study variables like HbA1c, hemoglobin, MCV, MCHC, RDW, and FBS of the patients was 5.91±0.89%, 11.23±1.59 gm/dl, 76.32±9.50fl, 31.02±3.39mg/dl, 12.78±1.51 and 100.53±15.52mg/dl respectively. A significant correlation between HbA1c and RDW was found and showed that both variables were positively correlated with each other. (r= 320, p=0.001). Conclusion: RDW correlates with HbA1C in female Type II diabetes patients, suggesting CBC, including RDW, as a cost-effective diagnostic marker alongside HbA1c for glycemic status assessment.

Adult Acne: Its Response to Therapy

Abstract Background: Although acne is principally a disorder of adolescence, the prevalence of adult acne is increasing. Adult acne has been defined as presence of acne beyond the age of 25 years. Various studies have shown that a significant percentage of adult women with acne failed to respond to treatment with systemic antibiotics and isotretinoin which indicates a need for treatment alternatives with improved effectiveness and acceptable side effects for resistant acne. Aim: This study aims to study the response of oral antibiotic therapy and oral hormonal therapy in Adult Acne. Objective: The objective of the study is to examine the response of oral antibiotic and oral hormonal therapy along with their side effects in cases diagnosed with adult acne. Material and Methods: (i) Study design: Interventional study, (ii) Basis of adequate sample size: All patients diagnosed with adult acne will be considered for study. Seventy-two adult female patients presenting with acne fulfilling the inclusion and exclusion criterias were enrolled for the study. (iii) Sampling frame and method: Written informed consent will be obtained and identity of the participants will be kept confidential. Sequential photographs will be taken after patient’s consent to check the response rate. Data will be analyzed using ‘Friedman test”. Result: Based on the results of our study, it can be concluded that although both antibiotics and hormonal therapy improved acne lesions, but results were statistically significant with hormonal therapy as compared to antibiotic therapy. Conclusion: Both antibiotic and hormonal therapies are safe and effective options for treating adult acne. All patients of adult acne may not have an underlying hormonal imbalance or hyperandrogenism, thus the role of oral antibiotics in the treatment should not be underestimated.

Quality of Life and Its Accompanying Factors among Adult Female Patients with Chronic Bronchial Asthma

Background: Asthma is a well-known chronic respiratory disease and a common global health problem. In Bangladesh, more than 100 million people are suffering from cough and shortness of breath. Patients with a known diagnosis of asthma are an important determinant of reduced quality of life. Objectives: To determine the quality of life and its accompanying factors among adult female patients with chronic bronchial asthma. Materials and methods: This cross-sectional study was conducted at the National Institute of Diseases of the Chest and Hospital, Dhaka from January to December 2021. Total eighty-five diagnosed adult female bronchial asthma patients were included in this study. Data were collected by face-to-face interviews with a semi-structured questionnaire using the Asthma Quality of Life Questionnaire (AQLQ) and Asthma Control Test (ACT) scale. The checklist was used for collecting data by reviewing medical records. Results: Among all the patients, the mean (±SD) age was 39.74±8.98 years and the highest frequency 48 (56.5%) patient’s age were in the 31-45 years group. In this study, the mean AQLQ score was 3.55 so, it indicated a moderate degree of impairment of quality of life and the most affected domain was environmental stimuli. Among all patients, 52 (61.2%) had partially controlled asthma. The study finding showed that the level of impairment of quality of life decreased with the increase of age (p=0.001). Uncontrolled asthma was associated with a lower quality of life (p=0.001). The low educational level 25 (29.4%), residing in rural areas 26 (30.6%) and having comorbidity 44 (51.8%) adversely affected the level of AQLQ. Conclusion: Now a day’s chronic bronchial asthma is a major public health issue, and it affects the quality of life. So, the current study may contribute to the prevention of worsening the level of impairment of quality of life in bronchial asthma patients. Eastern Med Coll J. July 2023; 8 (2):61-67

Subtunical Reduction Clitoroplasty of a 22 years old Female for Clitoromegaly with Congenital Adrenal Hyperplasia-Case Report

Clitoromegaly is an abnormal condition commonly related to congenital adrenal hyperplasia. We presented a 22 years old adult female patient with chief complaint of enlarged clitoris since birth, other female secondary sexual characteristics were normal. The karyotype test result was 46 XX. Subtunical resection of erectile cavernous tissue of the enlarged clitoris with preservation of intact blood supply to the glans is a safe method of diminishing shaft and glans size and allow the patient to do sexual activity after marriage during a two-years follow up. Bangabandhu Sheikh Mujib Med. Coll. J. 2023;2(2):127-130.

The role of psychosocial factors in the interprofessional management of women with chronic pelvic pain: A systematic review.

Chronic pelvic pain (CPP) is a common pain disorder in women associated with negative biopsychosocial consequences. The multifactorial etiology and maintaining aspects of CPP logically require an interprofessional treatment approach. However, the effects of interprofessional treatment strategies on psychosocial factors remain unclear. The study aims to investigate how interprofessional therapy helps to treat psychosocial factors in women with CPP. The systematic review summarizes the current evidence of interprofessional treatment in women with CPP. A systematic literature review was performed in six databases (Medline, Web of Science, Cochrane Library, PEDro, CINAHL, and PsycINFO) until February 2023. Studies were selected in a two-step approach applying as inclusion criteria the search combinations of Chronic Pelvic Pain and CPP, synonyms for interprofessional therapies, and for female patients. Studies were excluded if they were not quantitative primary research published in English, if CPP was not defined appropriately, if the study population was not female adult patients, if the interprofessional intervention was not operationalized appropriately, if they were single case studies, and if outcomes did not include at least one of the psychosocial factors pain, depressive symptoms, pain catastrophizing, fear, or anxiety. Risk of bias of the included studies was rated with the McMaster Critical Review Form. Studies were summarized narratively. The review is registered in PROSPERO (CRD42023391008). Five studies with a total sample size of n = 186 women were included, three of them were uncontrolled retrospective before-after chart review. Only one study used a randomized controlled design, the other study used a non-randomized controlled group. The studies' methodological quality is adequate with perspective of study design. The multiprofessional treatment approaches used in the studies differed with regard to professions involved, therapy methods, and modalities. Psychosocial outcome measures were pain (five studies), depressive symptoms (three studies), and anxiety symptoms (four studies). Although interprofessional treatment strategies for women with CPP are recommended in existing guidelines, available evidence is scarce and does not allow for identification of the best interprofessional treatment approach. The effect on psychosocial factors remains unclear. More research is needed determining the best practice interprofessional treatment option for women with CPP.

The subjective assessment of work and social adjustment impairments and associated psychopathologies in Japanese adult female patients with anorexia nervosa.

Patients with anorexia nervosa (AN) sometimes undergo a chronic course, and they hardly maintain social participation. Work and social adjustment impairments are generally significantly associated with the clinical symptoms of eating disorders. Psychopathologies associated with the subjective social difficulties of patients with AN have been unclear. This study examined the association between AN psychopathologies and work and social adjustment impairments in adult female patients with AN. This study included 36 Japanese adult female patients with AN who completed the Work and Social Adjustment Scale (WSAS) and the Eating Disorder Inventory-2 (EDI-2). Spearman's rank correlation coefficient was used to assess correlations between WSAS and EDI-2 or demographic variables. The mean age was 31.8 years, the mean current body mass index was 13.4 kg/m2, and the median illness duration was 5 years. Patients demonstrated social difficulties, especially in social leisure activities. The total WSAS scores were significantly correlated with EDI-2 "impulse regulation" and "asceticism." WSAS "social leisure" was significantly correlated with EDI-2 "bulimia," "interoceptive awareness," "impulse regulation," and "asceticism." Psychopathologies, such as impulse regulation, asceticism, and interoceptive awareness, may be related factors to social difficulties. Emotion regulation, such as impulse regulation and emotional awareness, could be an important realm of treatment not only for psychopathology but also for social functioning in patients with AN.

Radial and ulnar nerve palsies in closed humerus fracture: A case report and literature review

Fractures of the humeral shaft are commonly associated with radial nerve injury because of the anatomical course of the nerve. An ulnar nerve injury is rarely associated with such fractures. We present a case of a humeral shaft fracture with combined radial and ulnar nerve injuries in a female adult patient. The patient subsequently underwent radial and ulnar nerve exploration with internal fixation of the left humerus. According to our literature review, no similar cases were previously reported.

Albuminuria Is Affected by Urinary Tract Infection: A Comparison between Biochemical Quantitative Method and Automatic Urine Chemistry Analyzer UC-3500.

The automated urine reagent strip test is a cost-effective tool for detecting albuminuria in patients. However, prior research has not investigated how urinary tract infections (UTIs) affect the test's accuracy. Therefore, this study aims to assess the impact of UTIs on albuminuria diagnosis using both the biochemical quantitative method and the test strip method of the Fully Automatic Urine Chemistry Analyzer, UC-3500 (Sysmex, Kobe, Japan). From March to December 2019, we prospectively collected midstream urine from adult female UTI patients before and after one week of cephalexin treatment. The urine samples were subjected to culture, routine urinalysis, and albuminuria diagnosis using the biochemical quantitative method and UC-3500. Albuminuria was defined as a urine albumin to creatinine ratio (UACR) ≥ 30 mg/g in the biochemical quantitative method. The results were compared between the two methods. Among fifty-four female patients (average age: 50.5 ± 4.4 years) with UTIs, 24 (44.44%) had transient albuminuria. The quantitative UACR significantly decreased after one week of antibiotic treatment (median: 53 mg/g to 9 mg/g; median difference: -0.54, p < 0.0001). UC-3500 exhibited a higher false positive rate for diagnosing albuminuria during UTIs (42%) compared to after treatment (19%). Its agreement with the biochemical quantitative method was moderate during UTI (κ = 0.49, 95% confidence interval [CI]: 0.24-0.73) and good after treatment (κ = 0.65, 95% CI: 0.45-0.86). UC-3500's accuracy in diagnosing albuminuria is influenced by UTIs, leading to either transient albuminuria or a false positive reaction of the test strip. UTI should be excluded or treated before its application in albuminuria screening.

Clinical analysis of adult oculomoclonus-myoclonus syndrome with vertigo

The clinical manifestation, physical and laboratory examination, electrophysiological, and imaging data of 2 female adult OMS patients with vertigo were analyzed at the Department of Neurology of the First Medical Center of Chinese PLA General Hospital from February 2021 to March 2022. The treatment strategy and clinical outcome were followed up. The two female patients were aged 42 and 66 years. Anti-NMDA receptor antibody and anti-GABAB receptor antibody were detected in serological screening, respectively. The two patients met the diagnostic criteria for OMS, and one was screened for breast tumor. The clinical symptoms of the two patients were relieved after immunomodulation therapy. OMS is a group of rare clinical syndromes; its clinical evaluation process should be standardized and the etiology should be actively searched for.

External validation of a cardiovascular risk model for Omani patients with type 2 diabetes mellitus: a retrospective cohort study

ObjectivesTo externally validate a recently developed cardiovascular disease (CVD) risk model for Omanis with type 2 diabetes mellitus (T2DM).DesignRetrospective cohort study.SettingNine primary care centres in Muscat Governorate, Oman.ParticipantsA total of...

Efficacy of Manual Vacuum Aspiration versus Dilatation and Curettage in First Trimester Miscarriages

Objective: To compare the efficacy of Manual Vacuum Aspiration (MVA) with Dilatation and Curettage (DNC) in miscarriages of the first trimester. Study Design: Quasi-experimental study. Place and Duration of Study: Department of Obstetrics and Gynaecology CMH, Peshawar Pakistan, from Feb to Aug 2018. Methodology: A total number of 182 Adult female (20-35 years of age) patients having miscarriage during the first trimester who were either primigravida or with previous history of spontaneous vaginal delivery were included in this study. Patients were assigned randomly into Manual vacuum aspiration (MVA) and Dilatation and Curettage (DNC) groups using the draw randomization technique. Data regarding the efficacy of both procedures and procedural success rate was measured in all patients. Results: A total of 182 Adult female patients, with a mean age of 30.53+5.23 years, having miscarriage in the first trimester, were evaluated. The mean gestational age at the time of abortion was 8.64+1.30 weeks, and the mean parity of study females was 1.96±0.82. The procedure was successfully done in 87(95.6%) patients in the MVA Group versus 84(92.3%) in the D&amp;C Group (p-value 0.35). Conclusion: Manual vacuum aspiration (MVA) is an effective and safe method of abortion with a success rate comparable to that of Dilatation and Curettage (D&amp;C).

Neuromodulation with aerobic exercise reduces fatigue in systemic lupus erythematosus: a randomised, sham-controlled, double-blind study.

Transcranial direct current stimulation (tDCS) combined with aerobic exercise (tDCS-AE) effectively reduces fatigue in patients with fibromyalgia. However, no study has assessed this method in systemic lupus erythematosus (SLE) patients with significant fatigue. Therefore, we evaluated the safety and efficacy of tDCS-AE for significant fatigue symptoms in adult female SLE patients. This randomised, sham-controlled, double-blind study included 25 patients with SLE in remission or low disease activity (SLEDAI-2K £4) and with significant fatigue [≥36 points on the Fatigue Severity Scale (FSS) or ≥38 points on the Modified Fatigue Scale (MFIS)]. The patients received sham or tDCS for five consecutive days. The anode and cathode were positioned at M1 and Fp2, respectively (international 10-20 EEG system). tDCS was applied at an intensity of 2mA, and density of 0.057mA/cm2 in the tDCS-AE group. Both groups underwent combined low-intensity treadmill exercise. FSS, MFIS, pain visual analogue scale, physical activity, and sleep quality were evaluated at baseline and on days 7, 30, and 60. Adherence and safety were assessed using a standardised questionnaire. Improvement in fatigue levels was observed in both groups. However, a sustained reduction in fatigue levels on days 30 and 60 occurred only with tDCS-AEs (p<0.05). No significant differences were observed in pain level, sleep quality, or physical activity. No disease flares occurred and the adverse effects were mild and transient. Finally, the patient's adherence to the treatment was satisfactory. Despite isolated AEs, there was an improvement in fatigue, however, only tDCS-AE maintained significant and sustained improvement.

Improving the cancer adult patient support network (iCAN): a pilot study on a communication model and modified focus group

BackgroundMany consider that cancer has the greatest impact of any disease in the world, and it can drastically limit patients’ quality of life. Combating such a life-threatening disease can pose many challenges to daily life, highlighted by demonstrating the need to discuss one’s health status within a focus group and encourage treatment compliance.Aimthe purposes of this study were to share the authors’ experience of a modified focus group in an Oral Medicine Unit, termed “Improving Cancer Adult Patients Support Network” (iCAN), and to evaluate how effective communication could improve patients’ quality of life and empower them by virtue of enhanced knowledge and an awareness of cancer management.Methodsthe paper adhered to the COREQ checklist regarding its reporting procedures. The iCAN format was precisely reproduced four times with four groups, consisting of 12 adult male and female patients with solid cancers. They discussed several main topics relating to cancer treatment, as chosen by a majority of the participants. Four specialists were involved in the discussion of the selected topics The iCAN format was faithfully reproduced during each meeting, with the participants in the roles of moderator and health specialists. Finally, a satisfaction questionnaire was administered.Resultsthe most reliable results demonstrated a marked change in lifestyle and eating habits in more than 50% of participants. More than 80% were unaware of the side effects of cancer treatments in general and the oral mucosa in particular. Each meeting reported a maximum degree of satisfaction experienced by the participants.ConclusioniCAN focus group meetings appear to have facilitated a process of narrative interviewing, thereby improving the doctor-patient relationship underlying the humanization of the care process.

Type 2 diabetes progression in an adult Ugandan population with new-onset diabetes: an observational prospective study

BackgroundThe rate of progression of type 2 diabetes following diagnosis varies across individuals and populations. Studies investigating the progression of type 2 diabetes in adult African populations with newly diagnosed diabetes are limited. We aimed to investigate the prevalence and predictors of short-term (one year) diabetes progression in an adult Ugandan population with new-onset type 2 diabetes (type 2 diabetes diagnosed in < 3 months) initiated on oral hypoglycaemic agents (OHA).MethodsTwo hundred and seven adult participants with type 2 diabetes diagnosed within the previous three months were followed up for 12 months. We investigated the association of specific demographic, clinical, and metabolic characteristics, and short-term diabetes progression (defined as glycated haemoglobin or HbA1c ≥ 8% on ≥ 2 OHA and/or treatment intensification).ResultsOne hundred sixteen participants (56%) completed the follow-up period. Sixty-four participants (55.2%, 95% CI 45.7–64.4) showed evidence of diabetes progression during the 12-month period of follow-up. An HbA1c ≥ 8% on ≥ 2 OHA and treatment intensification were noted in 44.8% and 29.3% of the participants, respectively. On multivariate analysis, only the female gender (AOR 3.2, 95% CI 1.1–9.2, p = 0.03) was noted to be independently associated with short-term diabetes progression.ConclusionShort-term diabetes progression was relatively common in this study population and was independently associated with the female gender. Early intensified diabetes therapy in adult Ugandan female patients with new-onset type 2 diabetes should be emphasised to avert rapid short-term diabetes progression.

Impact of non-venereal genital dermatoses among female patients on the quality of life in a tertiary care center

Nonvenereal dermatoses of female external genitalia are genital diseases that are not transferred sexually and have a variety of etiologies. A prospective, observational study of adult female patients with nonvenereal dermatoses was conducted. A complete history and dermatological examination were performed, with skin biopsy in a few cases to aid in diagnosis. The data was collected and analyzed. During the course of this study, 82 cases of nonvenereal genital dermatoses were encountered. This study found that the most common age group was 20 to 45 years old [56%]. The most common presenting complaint was itching. In 42% of instances, fungal infections such as tinea cruris, vulval candidiasis, and scabies were identified. Lichen sclerosus et atrophicus, lichen simplex chronicus, contact dermatitis, vitiligo, psoriasis, seborrheic keratosis, and pemphigus vulgaris are among the other dermatoses identified. The Finlay dermatological life quality index (DLQI) questionnaire was used to assess the influence on patients' quality of life. Inflammatory illnesses such as lichen simplex chronicus lichen sclerosus et atrophicus, pemphigus vulgaris, psoriasis, hidradenitis suppurativa, and vitiligo reduced their quality of life moderately to severely.

Contraceptive Use in Females With Advanced CKD: A Qualitative Study

Pregnancy in females with kidney disease is not uncommon and is associated with adverse maternal and fetal outcomes. The use of contraception in females with chronic kidney disease remains low. We sought to describe the perspectives of female patients with advanced chronic kidney disease on the use of contraception. Qualitative study. We conducted 5 focus group interviews involving 16 adult female patients with advanced chronic kidney disease (n=3nondialysis nontransplant chronic kidney disease, n=9kidney transplant, and n=4kidney failure receiving dialysis) in the United States, following which thematic saturation was reached. Interview transcripts were analyzed thematically. We identified the following 5 themes: 1) variable knowledge regarding reproductive health with kidney disease, 2) inadequate counseling about contraceptive use, 3) lack of interdisciplinary coordination regarding contraceptive use, 4) insufficient educational resources available to guide the contraceptive discussion, and 5) need for research to better understand reproductive needs in females with kidney disease. Patients were from a single center in the United States, and the study is limited by the transferability of findings to other settings. Patients with chronic kidney disease report emotional challenges with reproductive health, lack of counseling and care coordination, and insufficient resources for contraceptive use. Strategies to strengthen these factors may improve the quality of reproductive care and increase contraceptive use for females with chronic kidney disease. Pregnancy in females with kidney disease is common and associated with a higher risk of adverse maternal and fetal outcomes, but the use of contraception remains low. Little is known about female patients' experiences in contraceptive use that may contribute to low contraceptive use in this high-risk population. In the present study using focus group interviews, patients with chronic kidney disease reported emotional challenges with reproductive health, lack of counseling and care coordination, and insufficient resources for contraceptive use. Interventions are needed to strengthen these factors to improve the quality of reproductive care and increase contraceptive use for females with chronic kidney disease.

Referral and Prescription Patterns for Female Patients With Urinary Incontinence.

Although behavioral modifications, medications, and other interventions can improve urinary incontinence (UI), many women never receive them. To better characterize UI treatment patterns in primary care, we examined prescriptions and referrals to pelvic floor physical therapy (PFPT) and specialist physicians within a large Midwestern academic health system. Electronic health records were queried to identify a cohort of adult female patients receiving a new UI diagnosis during outpatient primary care visits from 2016 to 2020. Urinary incontinence referrals and referral completion were examined for the overall cohort, and medication prescriptions were examined for women with urgency or mixed UI. Logistic regression was used to assess the association of prescriptions and/or referrals with patient demographics, comorbidities, and UI diagnosis dates. In the year after primary care UI diagnosis, 37.2% of patients in the overall cohort (n = 4,382) received guideline-concordant care. This included 20.6% of women who were referred for further management: 17.7% to urology/urogynecology and 3.2% to PFPT. Most women who were referred attended an initial appointment. Among those with urgency (n = 2,398) or mixed UI (n = 552), 17.1% were prescribed medication. Women with stress (odds ratio [OR], 3.10; 95% CI, 2.53-3.79) and mixed UI (OR, 6.17; 95% CI, 4.03-9.66) were more likely to be referred for further management, and women diagnosed during the COVID-19 pandemic were less likely to be referred for further care (OR, 0.39; 95% CI, 0.29, 0.48). Only slightly above 1 in 3 women with a new diagnosis of UI in primary care received guideline-based medications or referrals within 1 year, suggesting missed opportunities for timely care.

Newly Diagnosed Anaplastic Astrocytoma: &gt; 23 Year Survival in a 31-Year and 11-Month-Old Female Treated with Antineoplastons

Rationale: Anaplastic astrocytoma (AA), a malignant brain tumor that arises from astrocytic cells, has a poor prognosis. It accounts for 6–7% of gliomas and 1-2% of brain tumors. Objectives: A 31-year and 11-month-old female with an AA is presented to discuss the efficacy of Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) in the treatment of AA. She presented to the Burzynski Clinic (BC) for treatment and was enrolled in Protocol BT-08, “Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Anaplastic Astrocytoma”, receiving both intravenous (IV) and oral Antineoplastons A10 and AS2-1 (ANP therapy). IV ANP therapy was delivered continuously via subclavian catheter and infusion pump. Tumor response was determined by comparison of baseline brain magnetic resonance imaging (MRI) to sequential brain MRIs during therapy. Findings: The patient presented to the BC with no prior treatment and a one-month history of right arm clumsiness and right leg weakness. Brain MRI and stereotactic biopsy performed elsewhere had demonstrated an AA. Baseline MRI at the BC showed a 2.0 cm2 nonenhancing lesion and two enhancing lesions (0.02 cm2 and 0.15 cm2 ) in the left parietal lobe. IV ANP therapy was given over 56 days, and a complete response (CR) was demonstrated after one month of therapy. Oral ANP therapy was subsequently provided for 17 months. At last follow-up, in June 2023, the patient was healthy and showed no evidence of recurrent disease. She had an overall survival (OS) of &gt; 23 years and one month since diagnosis and an OS of &gt; 23 years since the start of IV ANP therapy. Conclusions: The utilization of ANP therapy in an adult female patient with AA is presented. The patient achieved a CR and prolonged OS, suggesting that ANP therapy may be an effective therapeutic option for adults with AA.

B-138 Skewed Demographics of Patient Population Contributes to Selection Biases in Clinical Study Population

Abstract Background The racial, ethnic and sex compositions of a study population may impact the clinical performance of a biomarker. In a prospective clinical study to evaluate biomarkers for asthmatic and allergic conditions in a large medical center in the upper Midwest, a largely White-alone patient population was encountered. Using several outreach strategies, potential eligible patients were contacted to enroll in a biomarker clinical study and to provide blood specimens. The patient demographics between the eligible candidates and the enrolled participants were compared. The analysis was carried out to understand the likelihood of enrollment in different race, ethnicity, and sex groups; and to identify factors that contribute to selection biases in enrolled cohorts. Methods Patients with eligible asthma and allergic conditions were selected based on relevant diagnostic codes in their electronic medical records, verified by clinical research coordinator. In accordance with Institutional Review Board approval, eligible patients were contacted via their electronic healthcare portal or with a phone call. The study information was also posted in an internal classified ad as an additional outreach strategy. Interested participants were then contacted a second time to complete consent. Upon consent, participants were considered as “enrolled”. Demographics information including sex, race, ethnicity, and age were de-identified for comparison analysis. Results Among all eligible patients, a disproportionally low representation of Blacks, Asians, and Hispanics (“non-White” groups) was observed, relative to regional demographics (22.2% non-White groups, 2021 census) and higher asthma and allergy prevalence in the non-White groups. In eligible adult patients (&amp;gt;18 years old) with asthma, only 13.4% were from non-White racial and ethnic groups. In eligible pediatric asthma patients, a larger proportion at 24.1% were from American Indian, Asian, Black, or Hispanic groups. In patients with allergic conditions, 10.3% of the adult patients were from non-White only groups, compared to 21.9% in pediatric patients. Among all eligible patients, White-alone patients were more likely to enroll in the study compared to their counterparts from non-White groups, further skewing the racial and ethnic distribution in the enrolled cohorts. As a result, less than 10% of enrolled adult patients were from non-White background in both allergy and asthma cohorts. Among the enrolled pediatric asthma and allergy patients, 16.9% and 10.3% respectively were from non-White groups. We also identified sex and age dependent enrollment behavior across different study cohorts. In adult groups, there were more female eligible patients (allergy: 66.7% female; asthma: 66.7% female) than male patients. Female adult patients were significantly more likely to participate, thus constituting 79.6% and 75.8% of the enrolled allergy and asthma cohorts. In the pediatric groups, male patients represented a larger share of eligible patients (allergy: 58.6%; asthma 64.7%). Female pediatric patients were still more likely to participate in the study. Hence, male and female enrolled patients were closer to equal distribution (allergy: 50.0% male; asthma 59.7% male). Conclusion The non-even distribution of demographics in eligible patients contributed to biased distribution in enrolled patients. Existing outreach approaches were not effective in reversing enrollment rates in underrepresented racial and ethnic groups.