JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH最新文献

{"title":"Rare Presentation of Pleural Empyema due to Non Typhoidal Salmonella-A Case Report","authors":"S. Priya, M. Rizwana, D. Senthil, B. Appalaraju, M. Arun","doi":"10.7860/jcdr/2023/59737.17425","DOIUrl":"https://doi.org/10.7860/jcdr/2023/59737.17425","url":null,"abstract":"Non typhoidal Salmonella usually causes bacteraemia, enterocolitis, and endovascular infection, but pleuro-pulmonary illness is uncommon, mainly observed in patients with a background of malignancy, underlying pulmonary diseases. Localisation of the infection has been witnessed at various sites following a bacteraemia but case reports on pulmonary focus are minimal. Here, we report a case of a 36 year old male patient who presented to Emergency Department with an underlying non Hodgkin’s Lymphoma along with a left sided pleural effusion. Pleural fluid tapping was done and the sample was sent for microbiological analysis. The pleural fluid culture along with serotyping confirmed the organism as Salmonella enterica serovar Typhimurium. The patient was discharged after parenteral Ceftriaxone therapy and symptom resolution. This case adds to the growing body of evidence of rare presentation of non typhoidal Salmonella as a probable etiological agent of infection in exudative pleural effusions.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"30 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72591065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Radiological Overview of Tubercular Arthritis of Wrist Joint: A Case Report","authors":"Susmita Ghosh, R. Dasar, Soumyabrata Debnath, Ashu Chakma, DE Asim","doi":"10.7860/jcdr/2023/61343.17939","DOIUrl":"https://doi.org/10.7860/jcdr/2023/61343.17939","url":null,"abstract":"Musculoskeletal Tuberculosis (TB) worldwide with wrist involvement is very rare. Maximum cases of tuberculous arthritis arise in patients born in and migrated from endemic regions, particularly in patients who are co-infected with Human Immunodeficiency Virus (HIV). Authors present a rare case of tuberculous arthritis of the wrist joint in a 64-year-old male having pain, swelling, and decreased range of motion in the left wrist for six months. X-ray and Computed Tomography (CT) showed erosion of carpal bones, reduced joint space, and soft tissue oedema and abscess. On Ultrasonography (USG) joint effusion and soft tissue oedema, were seen around the wrist joint, and on Magnetic Resonance Imaging (MRI) along with this marrow oedema were also noted. Aspirated fluid culture from abscess suggested Mycobacterium positive culture and Ziehl–Neelsen (Z-N) staining showed acid-fast bacilli. Antitubercular therapy was the mainstay of treatment. A high level of suspicion should be kept for TB in every infection of the wrist joint.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"50 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74600158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Attention Deficit Hyperactivity Disorder and Use of Mobile Phones among Children- Need for Concern?","authors":"A. Varghese, G. Mathew, Cinderella Xson","doi":"10.7860/jcdr/2023/60328.17984","DOIUrl":"https://doi.org/10.7860/jcdr/2023/60328.17984","url":null,"abstract":"Introduction: The prevalence of Attention Deficit Hyperactivity Disorder (ADHD) is on the rise. Among multiple factors that are linked with ADHD, electronic media use has been gaining considerable attention recently. There is only a limited source of information regarding the burden of ADHD and its association with screen time in the Indian context. Aim: Screening of the children for ADHD and its association with mobile phone use at an outpatient service in a tertiary care hospital in Kerala. Materials and Methods: A cross-sectional questionnaire-based study was conducted among 157 children in the outpatient services in a tertiary care hospital in Pathanamthitta district, Kerala, India. School-going children aged between 6 and 11 years were included in the study. ADHD screening was done using Conner’s Abbreviated Rating Scale (CARS). Results: The mean age of children was 8.1±1.9 years. All the participants used mobile phones, and 15 (9.6%) owned one. The mean duration of mobile phone use per day was 1.4±0.7 hours. Among participants, 53 (33.8%) used mobile phones for more than one hour daily. Parents reported that nearly one-fifth of the children use mobile phones late at night (after 10 pm). Among children, 22.9% screened positive for ADHD. The ADHD scores are significantly correlated with the duration of mobile phone use (r=0.368 p<0.001). Among the children who used mobile phones for more than a year, 32.1% screened positive for ADHD (OR=3.21, CI 1.41-7.32). The mean ADHD score was significantly higher among children with >1 hour of mobile phone use/day than those who use <1 hour/day (t-test=-2.27 p-value=0.025). The vast majority, 148 (94.2%), also noticed behavioural changes among children when denied mobile phones. Significant changes included anger (22.9%), sadness (31.8%), withdrawal (20%), frustration (17.8%) and violence (8.9%). Conclusion: In this study, 22.9% of children screened positive for ADHD. Mobile phone use was found to be significantly associated with ADHD.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"42 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80102856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum miRNA-30a-5p in Steroid Sensitive Idiopathic Nephrotic Syndrome in Indian Children: A Case-control Study","authors":"Abhishek Sreekumar, Gundyadka Moideen Safwan, Shilpa J Shetty, S. Kumari, R. Shenoy, V. Shenoy","doi":"10.7860/jcdr/2023/59329.17683","DOIUrl":"https://doi.org/10.7860/jcdr/2023/59329.17683","url":null,"abstract":"Introduction: Childhood Nephrotic Syndrome (NS) is a podocytopathy. Micro Ribonucleic Acid (miRNA), composed of 21-25 non coding nucleotides, regulates gene expression by inhibiting protein transcription by binding to complementary messenger RNA. The microRNA-30a is expressed in the human glomerular podocytes and collecting ducts. This microRNA protects the podocytes by targeting the Calcineurin-nuclear Factor of Activated T cells (NFATc) pathways. Serum microRNA30a-5p is a validated biomarker which is upregulated in NS. Aim: To determine the serum miRNA-30a-5p in steroid sensitive idiopathic NS in Indian children. Materials and Methods: This case-control study was conducted at the Department of Paediatrics, KS Hegde Medical Academy, Mangalore, Karnataka, India, from from January 2018 to June 2019. Thirty children with NS and age and gender matched controls were recruited. Relative expression of microRNA-30a5p was analysed by Real-Time quantitative Polymerase Chain Reaction (RT-qPCR). Estimations were done both in cases and controls at enrollment and also at four weeks when in remission in cases. The fold change was calculated as a power of cycle threshold. Statistical tests Kolmogorov-Smirnov test was used to establish the normality using Statistical Package for Social Sciences (SPSS) version 22.0. Results: There was upregulation of microRNA-30a-5p expression among children with NS with a significant fold change (~184) at enrollment. The levels declined, but remained above baseline (~6) after four weeks of treatment when compared to controls. The mean differences in delta threshold cycle and threshold cycle between the three groups were significant (p<0.001). There was no correlation with the biochemical parameters. Conclusion: The present study concludes that serum microRNA-30a-5p expression is upregulated in children with steroid sensitive NS in Indian children.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"1 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80120411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multifactorial Intraoperative Uterine Scar Dehiscence: A Case Report","authors":"Thacker Shriya Himmat, Sadhana Prasad Kaware","doi":"10.7860/jcdr/2023/60989.17731","DOIUrl":"https://doi.org/10.7860/jcdr/2023/60989.17731","url":null,"abstract":"Now-a-days, the number of Caesarean section (c-section) has increased, also the complications of c-section has increased. Obstetricians often encounter uterine scar dehiscence during delivery by c-section. However, it is rare to find a uterine scar dehiscence which is extending over one-third of the anterior uterine wall and it is yet to build the best surgical approach for repairing this rare complication of c-section or a torn anterior wall during delivery. Herein, a 23-year-old female who is Rhesus factor (Rh) negative G2P1L1 with seven months of amenorrhea came with chief complaints of pain in the abdomen since morning. On ultrasonography, severe oligohydramnios was diagnosed as Amniotic Fluid Index (AFI) was >5 cm. Hence, the patient was taken for emergency Lower Segment Caesarean Section (LSCS), Lower Uterine Section (LUS) was papery thin, uterovaginal fold of peritoneum was opened and the bladder was pushed down. One-third of the anterior uterine wall was involved. LUS was sutured using vicryl No. 1 and complete haemostasis was achieved. As uterine scar dehiscence is not preventable, efforts should be made to manage it efficiently and repair the myometrium safely.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"8 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80240534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Relationship between Breast Cancer Prevention and Breast Cancer Screening Behaviours in Tehranian Women: A Structural Equation Modeling Analysis","authors":"Mahla Rajabzadeh, R. Naderi, Sattar Bab, M. Riahi, F. Bahrami, M. Eghbali, Fateme Haseli","doi":"10.7860/jcdr/2023/62390.18134","DOIUrl":"https://doi.org/10.7860/jcdr/2023/62390.18134","url":null,"abstract":"Introduction: Breast cancer is the most commonly occurring cancer in women. It is also one of the most important health issues in many countries. Its high prevalence in women makes it necessary to encourage breast cancer screening behaviours. Aim: To investigate the relationship between breast cancer prevention behaviour and its screening behaviour in Tehranian women. Materials and Methods: This was cross-sectional study conducted on 859 women from November to December 2019 by the Iran University of Medical Sciences in Tehran, Iran. These women were selected by the multistage cluster method among five socio-economic classes living in different districts of Tehran. Structural Equation Modeling (SEM) was used to determine the relationship between breast cancer prevention behaviour and its screening behaviour. Data were analysed by Statistical Package for Social Sciences (SPSS) version 22.0 and Analysis of Moment Structures (AMOS) software. The level of significance was set at 0.05. Results: The mean age of the participants was 42±6.94 years. Also,137 (15.9%) of the participants were single, and 604 (70.3%) were married, 78 (9.08%) were divorced and rest widow. Among the studied subjects, 510 (57%) had unfavourable breast cancer screening behaviour. In Pearson’s correlation test, there was a direct and significant relationship between the mean score of breast cancer prevention behaviour and its subscales with breast cancer screening behaviour, except for the dimension of information-seeking (r=0.35, p=0.007). In other words, with the increased breast cancer prevention behaviour, breast cancer screening behaviour also increased. The results of SEM analysis showed that breast cancer prevention behaviour was positively correlated to breast cancer screening behaviour (p<0.001), and about 41% of changes in the breast cancer screening behaviour could be explained by the breast cancer prevention behaviour (β=0.41, p=0.01). Conclusion: Based on the results, it seems vital to take measures to inform and educate women about breast cancer and its complications, problems, prevention, screening, and diagnostic methods. The findings of this study can be used to increase motivation in the design of interventions in order to improve attitude, strengthen self-efficacy, reduce stress, and improve breast cancer screening behaviour.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"15 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78870891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Histopathological Evaluation and Analysis of Immunohistochemical Markers p53 and CD44S in Renal Cell Carcinoma: A Cross-sectional Study","authors":"Shivani Gupta, C. W. Devadass, Shubham Varshney, Sml Prakash Babu","doi":"10.7860/jcdr/2023/63352.18192","DOIUrl":"https://doi.org/10.7860/jcdr/2023/63352.18192","url":null,"abstract":"Introduction: Renal Cell Carcinoma (RCC) is the 9th and 14th most common cancer in men and women, respectively, and among the most lethal urological cancers. Upto 30% of patients experience recurrence within five years postnephrectomy. Therefore, the predictors of disease survival and molecular markers associated with clinical prognostic parameters should be identified. Aim: To examine the histopathological features of RCC and investigate the association of Tumour protein p53 (p53) and Cluster of Differentiation 44S (CD44S) expression with prognostic factors. Materials and Methods: The present prospective crosssectional study was conducted in the Department of Pathology, M.S Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India, from June 2017 to May 2019. Radical and partial nephrectomy specimens of RCC patients were obtained for the study. In each case age, tumour histologic type, tumour size, Fuhrman nuclear grade, rhabdoid features, necrosis, tumour stage and p53 and CD44S status were evaluated through immunohistochemistry. The Chi-square test was used to evaluate differences in CD44S and p53 expression among different groups. Data were entered in Microsoft (MS) Excel version 11 and was analysed using International Business Machines Statistical Package for the Social Sciences (IBM SPSS) software version 20.0. Results: The study included 50 RCC patients with a mean age of 56.64 years and male:female ratio was 2.8:1. CD44S and p53 positivity were noted in 33 (66%) and 27 (54%) patients, respectively. Weak, moderate, and strong CD44S expression were observed in 13 (26%), 8 (16%) and 12 (24%) patients, respectively and those of p53 in 9 (18%), 14 (28%) and 13 (26%) patients, respectively. Patients with higher Fuhrman nuclear grades exhibited stronger CD44S (n=24, 85.71%) and p53 (n=19, 67.85%) expression than did those with lower grades. Conclusion: The clear cell carcinoma is the most common histologic subtype. Presence of rhabdoid features and necrosis is seen with advanced Tumour, Nodal and Metastasis (TNM) stage. A significant association between p53 and CD44S immunohistochemical expression and higher Fuhrman nuclear grade suggests increased expression of p53 and CD44S and indicates an aggressive clinical course that can be used as a marker of poor prognosis.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"27 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79627586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Symptomatic Gallstone Disease and Associated Upper Gastrointestinal Pathologies-A Prospective Cohort Study","authors":"Haresh Kumar Gobu, D. Pai","doi":"10.7860/jcdr/2023/60310.18141","DOIUrl":"https://doi.org/10.7860/jcdr/2023/60310.18141","url":null,"abstract":"Introduction: Gallstones Disease (GSD) is one of the common medical problems leading to surgical intervention. The gold standard treatment for cholelithiasis is cholecystectomy. Co-existence of concurrent Upper Gastrointestinal (UGI) problems in GSD patients have attributed to the Post-cholecystectomy Syndrome (PCS). PCS consists of a group of abdominal symptoms, that recur and/or persist after cholecystectomy. The associated upper Gastrointestinal (GI) pathologies are identified by UGI endoscopy. Helicobacter pylori (H.pylori) infection has been implicated in many GI and extra-GI diseases. This aspect of identifying associated pathologies in symptomatic gallstone disease and identifying H.pylori infection using gene-sequencing method has not been studied in Indian population. Aim: To study the associated UGI pathology detected by preoperative UGI endoscopy in symptomatic GSD and to compare the outcome based on the trend of PCS overtime. Materials and Methods: This prospective cohort study conducted in the Department of Surgery at Mahatma Gandhi Medical College and Research Insititute, Puducherry, India. The duration of the study was 18 months, from January 2019 to July 2020. The individuals over 18 years of age, who were symptomatic and ultrasonographically proven to have cholelithiasis formed the study group. The sample size was calculated to be N=50 (reduced to N=30 due to Coronavirus Disease-2019 (COVID19) pandemic). Patients underwent UGI endoscopy prior to surgery, to assess for associated pathology including H.pylori. They were followed at regular intervals postoperatively and assessed based on questionnaire for the occurrence of PCS. The quantitative and qualitative variables were summarised as frequency, percentage and Pearson’s Chi-square test and Fisher’s-exact test, respectively. The sensitivity and specificity of H.pylori positivity by Histopathological Evaluation (HPE) in biopsy samples was compared to Polymerase Chain Reaction (PCR) as the gold standard. The significance level was set at p-value&lt;0.05. The trend of the symptoms was also studied overtime. Results: The mean age of the study population was 39.4±11.93 years. UGI abnormalities were present in 89.7% of the study group. H.pylori was identified in eight patients by histopathology examination while PCR detected 16 patients to have H.pylori. Sixteen out of 30 patients (53.3%) had PCS. It was also noted that, early PCS numbers tend to reduce over time, but the overall and late PCS numbers tend to increase over time. Although, a statistical analysis could not be performed, a graph was drawn to study the symptoms over the study period allowing observation of vital relation to gallstone disease. UGI pathology and H.pylori infection had a significant association with overall PCS with p-value=0.022 and 0.026, respectively. Conclusion: The present study recommends the use of preoperative UGI endoscopy in symptomatic GSD. The identification of H.pylori by PCR using population-based g","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"69 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76307410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of First, Second and Third Generation Probe after Phase I Therapy in Chronic Periodontitis PatientsA Randomised Clinical Study","authors":"Salma Raja, J. R. James, Tamilselvan Kumar, JP Mohan Raj, S. Divya, P. Fairlin, G. Rajkumar, M. Beulah","doi":"10.7860/jcdr/2023/60170.17948","DOIUrl":"https://doi.org/10.7860/jcdr/2023/60170.17948","url":null,"abstract":"Introduction: Periodontitis manifested by the presence of periodontal pocket depth and loss of attachment level is detected and measured by using periodontal probes. Various generations of probes have been discovered and are used to measure the pocket depth. There has been a huge difference in the accuracy of different generations of probe. Aim: To compare the interprobe accuracy of first, second and third generations of probe on clinical parameters in patients with chronic periodontitis. Materials and Methods: This randomised comparative clinical study was conducted at the Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India and included 30 chronic periodontitis patients, randomly allocated into three groups with each group consisting of 10 patients. The study was conducted over a period of eight months, from February 2001 to October 2001. Conventional periodontal probe, True Pressure Sensitive (TPS) probe and Florida probe were used to examine the patients. The probes were used in sequence of I, II and III for first 10 patients, II, III and I for next 10 patients and III, I and II for the last 10 patients to avoid bias due to examiner memory of clinical parameters. The recorded clinical parameters were Plaque Index (PI) (Silness and Loe 1964), Gingival Index (GI) (Loe and Silness 1963), Bleeding On Probing (BOP) index (Ainamo and Bay 1975), Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL). At baseline, all the clinical parameters were recorded by two calibrated examiners i.e., Examiner-1 and Examiner-2. Examiner-I recorded all the clinical parameters postoperatively at Ist, IInd, IIIrd and IVth consecutive weeks. The statistical analysis was done using paired t-test, One-way Analysis of Variance (ANOVA), studentised range test and Karl Pearson’s correlation coefficient test for calculation and comparison of interexaminer and intraexaminer variability. Results: Among the 30 patients included in the present study, 22 were males and eight were females. The mean age of the patients involved in the study was 45.16±1.33 years. The mean value of PI and GI showed a statistically significant reduction at different intervals with a value of 0.16±0.21 and 0.22±0.21 postoperatively (4th week). The probing depths measured using Williams periodontal probe, TPS probe and Florida probe were reduced to 4.2±0.4 mm, 3.9±0.4 mm and 3.5±0.4 mm, respectively at the end of 4th week. The CAL measured using Williams periodontal probe, TPS probe and Florida probe were reduced to 7.0±0.6 mm, 6.6±0.5 mm and 6.1±0.6 mm, respectively at the end of 4th week. Conclusion: The TPS probe, Williams probe, and Florida probe showed their superiority regarding the accuracy of recording clinical parameters in the decreasing order respectively","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"66 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76530358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of the Pharmacokinetics, Bioequivalence and Safety of Aqueous Progesterone Formulation Administered as either Intramuscular or Subcutaneous Injection versus Oil-based Progesterone Formulation Administered as Intramuscular Injection: A Randomised Study","authors":"Sonal S. Mehta, A. Chaturvedi","doi":"10.7860/jcdr/2023/56291.17889","DOIUrl":"https://doi.org/10.7860/jcdr/2023/56291.17889","url":null,"abstract":"Introduction: Progesterone is the treatment of choice for support of the luteal phase of controlled ovarian stimulation cycles in women undergoing an Assisted Reproductive Technology (ART) treatment. Available progesterone preparations include oral, vaginal and oil-based Intramuscular (i.m.) formulations. Oral formulation has poor bioavailability whereas vaginal formulations cause side-effects such as vaginal discharge and/ or local irritation. Oil-based progesterone formulations for i.m. use are associated with discomfort and pain at the injection site. Hence, a novel aqueous-based progesterone formulation for i.m./Subcutaneous (s.c.) was developed to avoid the local tolerability issues of the existing parenteral formulations. Aim: To assess single-dose Pharmacokinetics (PK) and relative bioavailability of i.m. (test-1; T1) or s.c. (test-2; T2) administration of novel aqueous progesterone formulation with i.m. (reference; R) administration of oil-based progesterone formulation. Materials and Methods: In this open-label, three-sequence, three-period, single-dose, cross-over study, 51 healthy human postmenopausal female subjects between 45 to 65 years of age were included. The study was conducted at Lambda Therapeutic Research Limited, Ahmedabad, Gujarat, India, between 21 May 2018 to 06 July 2018. Subjects were randomised to a single 25 mg dose of T1, T2 or R in three-periods (Period-I: T1, R, T2; Period-II: T2, T1, R; Period-III: R, T2, T1) with ≥18 days washout period. Blood samples were collected at prespecified time points in each period and analysed using validated liquid chromatography with tandem mass spectrometry. PK parameters {maximum plasma concentration (Cmax), time to reach Cmax (Tmax), area under the plasma concentration vs. time curve (AUC0-t), AUC from time 0 to ∞ (AUC0-∞), plasma half-life (t1/2)} were calculated from the plasma concentration vs. time profile by non compartmental model. The total study duration was about 47 days (11 hours prior to the drug administration in Period-I until the last ambulatory sample in Period-III). All patients provided written informed consent form and an approval from the Conscience-Independent Ethics Committee (CIEC) was taken. Descriptive statistics were calculated and reported for PK parameters for baseline corrected and uncorrected data. Results: Of 72 screened patients, 51 patients were included for the PK and statistical analysis. The mean±SD age of the patients was 55.1±4.67 years. The baseline corrected PK data shows that in T1, T2 and R arms, mean (range) Tmax were 1.00 (0.50– 1.75), 1.00 (0.75–1.75) and 8.00 hours (1.00–12.00), mean±SD t ½ (h) were 15.43±5.81, 15.27±6.68 and 19.80±6.35; mean±SD Cmax (ng/mL) were 101.91±73.07, 51.67±14.81 and 18.89±7.89, and mean±SD AUC0-t (ng/mL) were 385.10±89.29, 349.63±64.41 and 371.50±56.25, respectively. Similarly, the AUC0-∞ was also comparable in all three arms. The baseline uncorrected data were also in line with baseline corrected data. For AU","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"25 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76565228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}