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Background and Aims Methods Results Conclusion Metabolic dysfunction‐associated steatohepatitis (MASH) with bridging fibrosis is a critical stage in the evolution of fatty liver disease. Second harmonic generation/two‐photon excitation fluorescence (SHG/TPEF) microscopy with artificial intelligence (AI) provides sensitive and reproducible quantitation of liver fibrosis. This methodology was applied to gain an in‐depth understanding of intra‐stage fibrosis changes and septa analyses in a homogenous, well‐characterised group with MASH F3 fibrosis.Paired liver biopsies (baseline [BL] and end of treatment [EOT]) of 57 patients (placebo, n = 17 and tropifexor n = 40), with F3 fibrosis stage at BL according to the clinical research network (CRN) scoring, were included. Unstained sections were examined using SHG/TPEF microscopy with AI. Changes in liver fibrosis overall and in five areas of liver lobules were quantitatively assessed by qFibrosis. Progressive, regressive septa, and 12 septa parameters were quantitatively analysed.qFibrosis demonstrated fibrosis progression or regression in 14/17 (82%) patients receiving placebo, while the CRN scoring categorised 11/17 (65%) as ‘no change’. Radar maps with qFibrosis readouts visualised quantitative fibrosis dynamics in different areas of liver lobules even in cases categorised as ‘No Change’. Measurement of septa parameters objectively differentiated regressive and progressive septa (p < .001). Quantitative changes in individual septa parameters (BL to EOT) were observed both in the ‘no change’ and the ‘regression’ subgroups, as defined by the CRN scoring.SHG/TPEF microscopy with AI provides greater granularity and precision in assessing fibrosis dynamics in patients with bridging fibrosis, thus advancing knowledge development of fibrosis evolution in natural history and in clinical trials. [ABSTRACT FROM AUTHOR]

Objectives: Standardized criteria for disease activity and end of treatment of systemic treatment of atopic dermatitis have not been established. The objective of this study is to explore the experience using upadacitinib retrospectively, to find clues to weaning from systemic treatment, and to determine the algorithm for setting treatment goals and terminating systemic treatment. Methods: Fourteen patients treated with upadacitinib between 1 November 2021 and 31 December 2023 were enrolled in the study. Topical antiinflammatory treatments were combined. Treatment outcomes were established according to the European Task Force of Atopic Dermatitis guidelines. To evaluate disease status and control, we adopted the Treat to target strategy. Changes in serum biomarkers (TARC and IgE) were also observed. Results: All patients achieved EASI 50 after 52 weeks. At 76 weeks, 80% and 30% of patients achieved EASI 75 and EASI 90, respectively. Four patients completed upadacitinib, five patients discontinued treatment, and five patients remained on treatment. Two patients achieved complete remission without topical antiinflammatory treatment. Two patients discontinued due to adverse events. Patients with better treatment adherence, mainly topical treatment, tended to be able to withdraw from UPA. IgE increased from baseline in 11 patients (78.6%) and TARC increased in 14 patients (100%). These biomarkers decreased from the peak 24-48 weeks after initiating treatment, after the improvement of eczema. Conclusion: Combining systemic and topical treatments effectively induces remission in AD patients. Transitioning off systemic treatment begins by achieving remission maintained solely with topical therapy, emphasizing the importance of adherence. [ABSTRACT FROM AUTHOR]

Background: Psychotic spectrum disorders (PSD) are associated with poor social function. In this study, we investigate which of two different types of 2-month long training courses is more effective in improving day-to-day interactions and quality of life. Methods/design: Participants with psychotic spectrumdisorders will be randomly assigned to one of two training courses. Social functioning, everyday activities, social cognition and symptoms will be assessed at multiple timepoints, including baseline, treatment midpoint, end of treatment and 2-month follow-up. One training focuses on howto make good judgments about what other peoplemay be thinking or feeling in social situations, and why people might act in certain ways in different situations. The other training focuses on different strategies for handling everyday problems and stressors. Both trainings are done in one-on-one sessions with a research staff member. There will be 16-20 training sessions, each about 45-60 minutes long. The investigators will ask participants to attend 2 training sessions per week, so the total training time should be about 2 months. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusions To measure the effectiveness and sustainability of the Juniper UK digital weight‐loss service (DWLS), which delivers 6 months of personalized, proactive lifestyle coaching supplemented with tirzepatide to patients through a multidisciplinary team (MDT).An observer‐blinded randomized controlled trial (RCT) will be conducted on a cohort of non‐diabetic patients of the Juniper DWLS in the UK. Participants in both the intervention and control groups will receive weekly subcutaneous injections of 2.5 mg tirzepatide for 4 weeks, uptitrating the dose to 5.0 mg from weeks 5 to 8, and by 2.5 mg every 4 weeks until reaching 15 mg in week 21, which they will maintain until the end of the intervention period at 6 months, when participants will be taken off the medication. The intervention group will receive personalized weeklylifestyle coaching with a focus on protein intake and resistance training for 6 months. Participants in the control group will attend a diet and exercise group counselling session at programme inception and will be sent a summary of the session's content at months 2 and 4. Aside from these events, health coaches will only interact with control group participants on a reactive basis. From month 6 to month 12, participants from both groups will no longer have access to their MDTs. The trial's co‐primary endpoints include weight loss, fat‐free to fat‐mass ratio and composite strength measures at 12 months (6 months following the end of treatment), compared with baseline. Secondary endpoints include percentage change in weight, fat‐free to fat‐mass ratio, and composite strength from baseline to 6 months, side effect incidence, and change in cardiometabolic risk factors at 12 months. Quality of life and programme engagement represent the study's exploratory endpoints.A total of 688 participants enrolled in the study, with a mean age of 44.6 (± 11.4) years and a mean body mass index of 34.8 (± 7.5) kg/m2; 81.0% of participants are women, and 72.8% are of White ethnicity. More than three‐quarters of participants have at least one co‐morbidity, with dyslipidaemia (42.4%), hypertension (35.3%) and high cholesterol (31.8%) being the most prevalent conditions.This RCT will be the first to assess the effectiveness and sustainability of a real‐world intensive, multidisciplinary DWLS, and it should highlight the potential of such a service for long‐term obesity treatment compared with programmes that deliver standard health counselling. [ABSTRACT FROM AUTHOR]

This article discusses a retrospective cohort study that aimed to predict relapse in patients with chronic spontaneous urticaria (CSU) who were treated with omalizumab. CSU is a condition that affects a small percentage of the population and significantly impacts patients' quality of life. Omalizumab is the only registered therapy for CSU, but its discontinuation remains uncertain. The study found that approximately 30% of patients achieved long-term remission after 24 weeks of therapy, and most relapse episodes occurred within the first 6 weeks after treatment discontinuation. Factors such as higher Urticaria Activity Score (UAS7) after 24 weeks, longer time to treatment, and prior relapses increased the risk of relapse, while Hashimoto's disease favored remission. The findings can help determine appropriate treatment duration and withdrawal regimens. Further research is needed to optimize omalizumab withdrawal and identify additional predictive factors for long-term remissions and relapse rates in CSU patients. [Extracted from the article]

This document provides translated abstracts from the journal "Person-Centered & Experiential Psychotherapies." The first abstract discusses a study on Emotion Focused Therapy (EFT) for youth, which found that EFT-Y led to a significant decrease in emotion dysregulation and depression scores in the treatment group compared to the control group. The second abstract reviews research on Emotion-Focused Skills Training (EFST) for parents and children, highlighting its effectiveness in improving mental health. Another study examined factors that may predict dropout rates and treatment outcomes in psychotherapy for generalized anxiety disorder (GAD), finding that younger age, higher anxiety levels, and lower social support were associated with higher dropout rates and poorer treatment outcomes. Lastly, a case study explored the use of emotion-focused therapy in the treatment of a client with anorexia nervosa, tracking changes in emotional experience and the client's process throughout therapy. These abstracts provide valuable insights into the effectiveness and application of emotion-focused therapies for various populations and mental health concerns. [Extracted from the article]

Although there is considerable evidence to support Emotion Focused Therapy (EFT) in the adult population, it has not been empirically studied in youth. EFT does not rely on an individual's adherence to manualized strategies or between-session homework tasks, focusing instead on within-session processes. These processes activate and transform core emotions that are often linked to experiences with primary caregivers, family members, and other significant relationships. This novel study reports on an adaptation of EFT for youth. Building upon the evidence base for EFT with adults, we examined the impact of an 8-session EFT-Y intervention on clinical disorders in youth (n = 43). Using a single-site randomized waitlist-controlled design, outcomes from a treatment group (n = 22) were compared to a waitlist control group (n = 21), similar in age and presenting problems. In comparison to youth in the waitlist control group, the treatment group reported a significant decrease in their emotion dysregulation and depression scores at the end of treatment. Youth in the treatment group also demonstrated a decrease in their emotion difficulties, conduct problems, and overall difficulties, with baseline scores controlled for. These findings provide preliminary evidence that EFT-Y is an efficacious therapeutic approach for common child and adolescent psychopathology. [ABSTRACT FROM AUTHOR]

The phase 3b FREEDOM trial (ClinicalTrials.gov: NCT03755518) evaluates efficacy/safety of fedratinib in intermediate- or high-risk myelofibrosis patients with platelet count ≥50 × 109/L, previously treated with ruxolitinib. The trial design included protocol specified strategies to mitigate the risk for gastrointestinal (GI) adverse events (AEs), thiamine supplementation, and encephalopathy surveillance. Due to COVID-19, accrual was cut short with 38 patients enrolled. In the efficacy evaluable population (n = 35), nine (25.7%; 95% confidence interval 12.5–43.3) patients achieved primary endpoint of ≥35% spleen volume reduction (SVR) at end of cycle (EOC) 6; and 22 (62.9%) patients showed best overall response of ≥35% SVR up to end of treatment. Sixteen (44.4%) patients showed ≥50% reduction in total symptom score at EOC6 (n = 36). Compared to previously reported JAKARTA-2 trial, rates of GI AEs were lower, and no patient developed encephalopathy. Overall, FREEDOM study showed clinically relevant spleen and symptom responses with fedratinib, and effective mitigation of GI AEs. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The aim of this study was to investigate the impact of the sodium–glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin on tissue fatty acid (FA) uptake in the skeletal muscle, brain, small intestine, and subcutaneous and visceral adipose tissue of individuals with type 2 diabetes by using positron emission tomography (PET). RESEARCH DESIGN AND METHODS: In a 6-week randomized double-blind placebo-controlled trial, 53 patients with type 2 diabetes treated with metformin received either 10 mg dapagliflozin or placebo daily. Tissue FA uptake was quantified at baseline and end of treatment with PET and the long-chain FA analog radiotracer 14(R , S)-[18F]fluoro-6-thia-heptadecanoic acid. Treatment effects were assessed using ANCOVA, and the results are reported as least square means and 95% CIs for the difference between groups. RESULTS: A total of 38 patients (dapagliflozin n = 21; placebo n = 17) completed the study. After 6 weeks, skeletal muscle FA uptake was increased by dapagliflozin compared with placebo (1.0 [0.07, 2.0] μmol ⋅ 100 g−1 ⋅ min−1; P = 0.032), whereas uptake was not significantly changed in the small intestine or visceral or subcutaneous adipose tissue. Dapagliflozin treatment significantly increased whole-brain FA uptake (0.10 [0.02, 0.17] μmol ⋅ 100 g−1 ⋅ min−1; P = 0.01), an effect observed in both gray and white matter regions. CONCLUSIONS: Six weeks of treatment with dapagliflozin increases skeletal muscle and brain FA uptake, partly driven by a rise in free FA availability. This finding is in accordance with previous indirect measurements showing enhanced FA metabolism in response to SGLT2 inhibition and extends the notion of a shift toward increased FA use to muscle and brain. [ABSTRACT FROM AUTHOR]

Loss and absence of melanocytes due to a number of factors is responsible for vitiligo; known to be the commonest disorder of pigmentation. The aim of the current work was to compare the efficacy and safety of excimer light with topical tacrolimus ointment 0.1% versus excimer light with topical bimatoprost gel 0.01% in treatment of facial vitiligo. The study was carried out on 48 patients presented with facial vitiligo. The patients were divided randomly using sealed envelope method into two groups (24 patients each). Group 1 were treated with excimer light plus topical tacrolimus ointment 0.1% and group 2 treated with excimer light plus topical bimatoprost gel 0.01%. Clinical improvement based on the quartile grading scale at the end of treatment did not show any statistically significant difference between groups. The majority of subjects in both groups experienced good to excellent improvement. Only 20.9% of patients in group 1 and 33.3% of subjects in group 2 achieved less than 50% repigmentation (p = 0.889). Our study demonstrated that 0.01% topical bimatoprost gel in combination with excimer light is considered safe and effective as treatment of nonsegmental facial vitiligo with comparable results to 0.1% tacrolimus. [ABSTRACT FROM AUTHOR]

The purpose of this report is to provide a comprehensive description of a post-transplant febrile patient's clinical course, complications, surgical procedure, and long-term management including evaluation by 18 F-fluorodeoxyglucose [(18 F)FDG] positron-emission tomography combined with computed tomography (PET/CT). A 35-year-old male, a postrenal transplant patient, developed chronic allograft dysfunction and presented with fever with chills, with suspicion of acute-on-chronic graft dysfunction, but no infective focus localization on chest X-ray, ultrasonography (USG) whole abdomen, or blood culture. Urine microscopy showed 8 to 10 pus cells/high-power field (hpf) and culture showed Klebsiella pneumoniae and Pseudomonas aeruginosa with low colony count. Culture-sensitive antibiotics were prescribed for 2 weeks, and after 3 weeks febrile episodes relapsed, symptoms progressed, and required emergency hospitalization due to acute painful urinary retention. Proteinuria and no growth were noted in urine analysis, serum creatinine was 5.36 mg/dL, and C-reactive protein was 15.7mg/dL, and remaining parameters were unremarkable. [ 18 F]FDG-PET/CT was considered in order to resolve diagnosis, which revealed abnormal heterogeneous tracer uptake in the enlarged prostate with hypodense areas within, suggesting prostatitis with abscess formation and pyelonephritis in the upper pole of the transplant kidney. USG kidney urinary bladder (KUB) correlation confirmed prostatic abscess and transurethral drainage done, and pus culture revealed Burkholderia pseudomallei. Culture-sensitive intravenous meropenem treatment was given for 3 weeks. At 5 weeks, follow-up [ 18 F]FDG-PET/CT showed low metabolic residual prostate uptake, suggesting a good response with residual infection. Thus, intravenous antibiotics was changed to oral antibiotics for another 6 weeks. His symptoms completely resolved at the end of treatment; however, his graft function worsened, with serum creatinine reaching 6 to 7 mg/dL, and eventually, after 8 months he became dialysis dependent. [ABSTRACT FROM AUTHOR]

• We conducted this meta -analysis based on relevant protocols, showed a complete overview of the available data in terms of prognostic value of HPV cell-free DNA in cervical cancer. • This study demonstrated that cervical cancer patients with positive HPV cell-free DNA detection at end of treatment had significantly worse oncological outcomes compared with that of negative patients. • Personalized monitoring of HPV cell-free DNA is expected to be a promising prognostic biomarker for cervical cancer patients. This meta -analysis aimed to investigate the association between circulating human papillomavirus (HPV) cell-free DNA and oncological outcomes of cervical cancer patients. Searches were performed in MEDLINE, Embase, and CENTRAL from their inception until 26 November 2023. Inclusion criteria were: (1) pathologically confirmed cervical cancer with available HPV test results; (2) detection of HPV cell-free DNA was performed in serum/plasma before or at end of treatment; (3) studies reported oncological outcomes of cervical cancer patients according to the levels of HPV cell-free DNA. Data extraction and study quality assessment were performed independently by two authors. Pooled hazard ratios and 95% confidence intervals were calculated using the inverse-variance method for survival outcomes. Five studies were finally included in this meta -analysis. Blood samples were collected from 167 patients before treatment, with 150 individuals available for analysis at the end of treatment. Furthermore, 82 patients with available samples at 3 months post-treatment were included in the analysis. The pooled results indicated a significant association between positive HPV cell-free DNA at end of treatment and worse progression-free survival in patients with cervical cancer (pooled hazard ratio: 5.49; 95 % confidence interval: 2.85–10.58; I2: 0 %). Similar findings were observed in patients with detectable HPV cell-free DNA at 3 months post-treatment (pooled hazard ratio: 7.86; 95 % confidence interval: 3.32–18.60; I2: 0 %). However, the detection of HPV cell-free DNA before treatment was not significantly associated with progression-free survival (pooled hazard ratio: 0.97; 95 % confidence interval: 0.55–1.71; I2: 0 %). Cervical cancer patients testing positive for HPV cell-free DNA at the end of treatment or 3 months post-treatment displayed significantly poorer oncological outcomes compared to those testing negative. Thus, personalized monitoring of HPV cell-free DNA holds promise as a prognostic biomarker for patients with cervical cancer. [ABSTRACT FROM AUTHOR]

AbstractBackgroundMethods and findingsConclusionAbbreviationsHepatitis C virus (HCV) is a major cause of chronic liver disease, in which liver stiffness increases. Liver stiffness measurements (LSM) are therefore essential in diagnosing liver diseases and predicting disease development. The study objective was to perform a comprehensive prospective assessment of the liver before, after and 4 years after treatment for HCV, including an assessment of the long-term outcome of fibrosis, steatosis and inflammation.Patients eligible for HCV treatment were included prospectively in 2018 (n = 47). Liver stiffness was measured using transient elastography and 2D shear-wave elastography (SWE). Blood tests, B-mode ultrasound (US) and SWE, were performed before, after (end of treatment [EOT]), 3 months after (EOT3) and 4 years after treatment (4Y). At the final visit, we added attenuation imaging and shear-wave dispersion slope (SWDS) measurements to assess steatosis and inflammation. Three months after treatment, the sustained virologic response rate was 93%. The median liver stiffness for baseline, EOT, EOT3 and 4Y was 8.1, 5.9, 5.6 and 6.3 kPa, respectively. There was a significant reduction in liver stiffness from baseline to EOT, and from EOT to EOT3. After 4 years, the mean attenuation coefficient (AC) was 0.58 dB/cm/MHz, and the mean SWDS value was 14.3 (m/s)/kHz.The treatment for HCV was highly effective. Measurements of liver stiffness decreased significantly after treatment and remained low after 4 years. AC measurements indicated low levels of liver steatosis. Shear-wave dispersion values indicated inflammation of the liver, but the clinical implication is undetermined and should be explored in larger studies.Clinicaltrials.gov: NCT03434470AC: attenuation coefficient; APRI: aspartate aminotransferase to platelet ratio index; ATI: attenuation imaging; cACLD: compensated advanced chronic liver disease; CAP: controlled attenuation parameter; FIB-4: Fibrosis-4 Index for liver fibrosis; HCC: hepatocellular carcinoma; LSM: liver stiffness measurement; NAFLD: non-alcoholic fatty liver disease; NASH: non-alcoholic steatohepatitis; SWDS: shear-wave dispersion slope; SWE: shear-wave elastography; US: ultrasound [ABSTRACT FROM AUTHOR]

Background: Urinary incontinence (UI) negatively affects the well-being of women globally. Pelvic Floor Muscle Training (PFMT) is a complex intervention that aims to decrease UI symptoms. Information about how the multiple complex components involved in PFMT achieve and maintain the desired effect are rarely studied as a whole. The evidence base lacks data about how women experience PFMT over time and in the longer-term. This study explored women's experiences of biofeedback-assisted PFMT and PFMT alone, to identify and understand what influenced self-reported adherence to PFMT, and UI outcomes over time. Methods: This rigorous longitudinal qualitative case study, nested within a randomised controlled trial, recruited forty cases (women with stress or mixed UI; 20 in biofeedback-assisted and 20 in PFMT alone group). A case included up to four semi-structured interviews with each woman (prior to starting PFMT, end of treatment [6 months], 12 months, 24 months). Analysis followed case study analytic traditions, resulting in a Programme Theory about PFMT from the perspectives of women with UI. Findings: The theory demonstrates factors that motivated women to seek UI treatment, and how these influenced long-term adherence. Therapists who delivered PFMT played a crucial role in supporting women to know how to undertake PFMT (to have capability). Some, but not all, women developed self-efficacy for PFMT. Where women did not have PFMT self-efficacy, adherence tended to be poor. When women had PFMT self-efficacy, the conditions to support adherence were present, but contextual factors could still intercede to inhibit adherence. The intercession of contextual factors was individual to a woman and her life, meaning any particular contextual factor had inconsistent influences on PFMT adherence over time for individual women and exerted varying influences across different women. Conclusion: Long term adherence to PFMT is a complex interaction between many different factors. Enquiring about an individual woman's motivation to seek treatment and understanding the contextual factors that affect an individual woman will enable a practitioner to support longer-term adherence. [ABSTRACT FROM AUTHOR]

Spinal cord injury (SCI) results in lesions that destroy tissue and spinal tracts, leading to deficits in locomotor and autonomic function. We have previously shown that after SCI, surviving motoneurons innervating hindlimb muscles exhibit extensive dendritic atrophy, which can be attenuated by treadmill training or treatment with gonadal hormones post-injury. We have also shown that following SCI, both exercise and treatment with gonadal hormones improve urinary function. Animals exercised with forced running wheel training show improved urinary function as measured by bladder cystometry and sphincter electromyography, and treatment with gonadal hormones improves voiding patterns as measured by metabolic cage testing.The objective of the current study was to examine the potential protective effects of exercise or hormone treatment on the structure and function of motoneurons innervating the external urethral sphincter (EUS) after contusive SCI.Gonadally intact young adult male rats received either a sham or a thoracic contusion injury. Immediately after injury, one cohort of animals was implanted with subcutaneous Silastic capsules filled with estradiol (E) and dihydrotestosterone (D) or left blank; continuous hormone treatment occurred for 4 weeks post-injury. A separate cohort of SCI-animals received either 12 weeks of forced wheel running exercise or no exercise treatment starting two weeks after injury. At the end of treatment, urinary void volume was measured using metabolic cages and EUS motoneurons were labeled with cholera toxin-conjugated horseradish peroxidase, allowing for assessment of dendritic morphology in three dimensions.Locomotor performance was improved in exercised animals after SCI. Void volumes increased after SCI in all animals; void volume was unaffected by treatment with exercise, but was dramatically improved by treatment with E + D. Similar to what we have previously reported for hindlimb motoneurons after SCI, dendritic length of EUS motoneurons was significantly decreased after SCI compared to sham animals. Exercise did not reverse injury-induced atrophy, however E + D treatment significantly protected dendritic length.These results suggest that some aspects of urinary dysfunction after SCI can be improved through treatment with gonadal hormones, potentially through their effects on EUS motoneurons. Moreover, a more comprehensive treatment regime that addresses multiple SCI-induced sequelae, i.e., locomotor and voiding deficits, would include both hormones and exercise. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this retrospective study was to investigate the influence of chemotherapy on the immune status of individual patients diagnosed with acute lymphoblastic leukemia (ALL) and to elucidate the clinical characteristics of immune reconstitution in ALL patients following chemotherapy. Methods: Clinical data of children with ALL were gathered, including information on the number of lymphocyte subsets prior to chemotherapy, at the end of therapy, six months, and one year after the end of the treatment. Results: A total of 146 children with ALL were included, and T cells, B cells, and NK cells all decreased to various degrees prior to treatment. The abnormal CD3 + T cell numbers group experienced a considerably higher mortality (21.9% vs. 6.1%) and recurrence rate (31.3% vs. 11.4%) compared to the normal group (P < 0.05). T cells, B cells, and NK cells were all significantly compromised at the end of therapy compared to the beginning of chemotherapy, with B cells being more severely compromised (P < 0.001). At the end of treatment, levels of B cells, CD4 + T cells, CD4/CD8, IgG and IgM in low risk (LR) group were significantly higher than those in intermediate risk (IR) group (P < 0.01), and levels of NK cells in LR group were evidently lower than those in IR group (P < 0.001). Six months after the end of therapy, all the above indicators recovered (P < 0.001) except CD4/CD8 ratio (P = 0.451). Conclusions: The immune systems of the ALL patients were severely compromised upon therapy withdrawal, particularly the B cells. At six months after the therapy ended, the B cells were basically restored to normal level, while the T-cell compartment was not. The impaired numbers of CD3 + T cell may contribute to a weakened anti-tumor response, potentially leading to a poorer prognosis. [ABSTRACT FROM AUTHOR]

AbstractBackgroundObjectivesMethodsResultsConclusionComorbidities complicate the management of tuberculosis (TB) and have become an essential part of the end TB strategy to eradicate TB. However, pulmonary TB has received the most attention, and little is known about the impact of comorbidities and other factors on outcomes in patients with extrapulmonary tuberculosis (EPTB).Our aim was to analyze the factors associated with hospitalization and mortality in EPTB at a hospital in Central India, using non-TB patients with similar clinical presentations as a comparison.Patients with presumptive EPTB were prospectively enrolled and followed up until the end of treatment or for at least 6 months. Detailed demographic and clinical information was collected for all participants, and patients were categorized as TB or non-TB using a composite reference standard. Multivariate logistic regression was used to analyze the impact of various clinical findings and risk factors on hospitalization and mortality.A total of 276 patients were categorized as TB cases and 175 as non-TB cases. Factors associated with hospitalization in children were younger age and non-adenitis site of disease. In adults, factors associated with mortality were older age, non-adenitis site of disease and HIV infection regardless of TB diagnosis, while diabetes mellitus increased the odds of mortality in EPTB patients.Our results show that comorbidities increase the odds of death in both TB and non-TB patients in low-resource settings. This argues for a shift away from the traditional vertical management of diseases in these areas and supports a continued focus on building robust healthcare systems. [ABSTRACT FROM AUTHOR]

Visceral leishmaniasis (VL) is a neglected tropical disease caused by parasites from the Leishmania (L.) donovani complex. VL is characterised by uncontrolled parasite replication in spleen, liver and bone marrow, and by an impaired immune response and high systemic levels of inflammation. Monocytes have been poorly characterised in VL patients. The aim of this study was to evaluate the expression levels of markers involved in the regulation of T cell responses on different subsets of monocytes from the blood of VL patients and healthy non-endemic controls (HNEC). Monocytes can broadly be divided into three subsets: classical, intermediate and non-classical monocytes. Our results show that the percentages of all three subsets stay similar at the time of VL diagnosis (ToD) and at the end of anti-leishmanial treatment (EoT). We first looked at co-stimulatory receptors: the expression levels of CD40 were significantly increased on classical and intermediate, but not non-classical monocytes, at ToD as compared to EoT and HNEC. CD80 expression levels were also increased on intermediate monocytes at ToD as compared to EoT and HNEC, and on classical monocytes only as compared to HNEC. The levels of CD86 were similar at EoT and ToD and in HNEC on classical and intermediate monocytes, but significantly higher at EoT on non-classical monocytes. We also looked at an inhibitory molecule, PD-L1. Our results show that the expression levels of PD-L1 is significantly higher on all three monocyte subsets at ToD as compared to HNEC, and to EoT on classical and intermediate monocytes. These results show that monocytes from the blood of VL patients upregulate both co-stimulatory and inhibitory receptors and that their expression levels are restored at EoT. Author summary: Visceral leishmaniasis (VL) is a neglected tropical disease caused by Leishmania parasites. VL is characterised by uncontrolled parasite replication in internal organs and is often fatal if untreated. Monocytes are part of a group of cells called white blood cells. These cells can become activated and play an important role against infections. They have been poorly characterised in VL patients. The aim of this study was to evaluate the expression levels of markers of activation on different subsets of monocytes from the blood of VL patients and healthy non-endemic controls (HNEC). We assessed the expression levels of monocyte markers that are essential for activating and regulating the immune response. Our results how that these are increased on some monocyte subsets at the time of diagnosis as compared to the end of treatment and HNEC. We also looked at a marker that can inhibit the immune response and show that it is highly expressed at the time of diagnosis as compared to the end of treatment and HNEC. These results show that monocytes from the blood of VL patients upregulate both activating and inhibitory receptors and that their expression levels are restored at the end of treatment. [ABSTRACT FROM AUTHOR]

This document is a summary of a study on the efficacy and safety of ISIS 449884 injection as a monotherapy for patients with type 2 diabetes. The study found that the use of ISIS 449884 resulted in a significant improvement in HbA1c levels compared to a placebo group. The treatment was well-tolerated with no serious adverse events reported. However, there were some limitations to the study, including a small sample size and a lack of data on hepatic lipid values and hepatic fat content. Overall, the study suggests that ISIS 449884 may be an effective and safe treatment option for patients with type 2 diabetes. [Extracted from the article]

Objective: To evaluate the effectiveness of pelvic floor muscle training (PFMT) on pelvic floor muscle (PFM) function and quality of life (QoL) in women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Methods: This study will be a randomized, controlled, parallel, and blinded clinical trial. The final sample will consist of 32 women diagnosed with SUI and cystocele (stage I and II). All volunteers will be assessed and reassessed using the same protocol: assessment form, gynecological examination, functional evaluation of PFM, and questionnaires to assess quality of life, urinary function, and sexual function. All volunteers will be evaluated for satisfaction levels post-treatment. The intervention will be PFMT, totaling 16 sessions to be conducted twice a week. Reevaluation will take place at the end of treatment and 1 month after completion of PFMT. Descriptive analysis and repeated measures ANOVA will be used for result analysis. A significance level of p<0.05 will be considered for all statistical tests. Ethics and dissemination: This study has been submitted to the Ethics in Research Committee of the Federal University of Rio Grande do Norte and approved under protocol number 5.826.563. It has been registered with the Brazilian Clinical Trials Registry ReBec (RBR-49p6g3t). It is expected that these studies will provide a deeper understanding of the efficacy of PFMT in women with SUI and cystocele. Additionally, it aims to provide more insights into the efficacy of PFMT prior to surgery. [ABSTRACT FROM AUTHOR]

To study the laser acupuncture (LA) effects on postmenopausal obese women's metabolic syndrome. Randomized controlled trial. Benha university hospital. Thirty postmenopausal women were randomized into two equal groups. Group A received a diet regimen and Group B received LA treatment for 30 min three times a week for two months beside the diet regimen. Included weight (W), body mass index (BMI), waist (WC), hip (HC), waist-hip ratio (WHR), systolic blood pressure (SBP), diastolic blood pressure (DBP), serum level of total cholesterol (TC), triglycerides (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), fasting blood glucose (FBG), fasting blood insulin (FBI), homeostatic model assessment-insulin resistance (HOMA-IR) before and after the end of treatment. The study's findings showed that both groups experienced a highly statistically significant decrease in the post-testing mean value of W, BMI, WC, HC, WHR, SBP, DBP, TC, TG, LDL, FBG, FBI, and HOMA-IR, while both groups experienced a significant increase in the post-treatment mean value of HDL (p 0.0001). The posttreatment SBP, DBP, TC, TG, LDL, FBS, FBI and insulin resistance were significantly lower while HDL was significantly higher in women who received combined LA and diet regimen compared to those who received dietary regimen only. LA beside the nutritional intervention is a physical therapy technique that may be used safely, easily, and effectively to minimize metabolic syndrome features during menopause. [ABSTRACT FROM AUTHOR]

Background: The aim of our study was to investigate serum chitotriosidase level in tuberculosis patients, its relationship with microbiological and clinical parameters, and response to treatment. Materials and methods: This longitudinal panel study included 149 patients with confirmed TB disease. Serum chitotriosidase activity was measured at the beginning and the end of treatment. Factors associated with chitotriosidase activity were explored using univariate and multivariable logistic regression analysis. Results: Out of 149 study participants, 71(47.7%) were female. The mean age was 53.0 (SD = 18.2). Majority of cases were new 118(79.2), predominantly 145 (97.3%) having pulmonary tuberculosis. More than half of the patients were sputum smear positive 91 (61.1%) while culture positive in 146 (98%) of them. According to radiological findings, cavitary lesions were found in 92 (63.4%) patients. Anti TB treatment was associated with significant decrease in serum chitotriosidase level (< 0.001). New TB treatment (OR = 4.41%;95% CI = 1.20–9.89), and cavitary lesions (OR = 3.86;95%CI = 0,59-26.57) were found to be significantly associated with decrease of chitotriosidase activity. Conclusions: The results of our study showed that serum chitotriosidase values are strong biomarkers for starting anti TB treatment and for treatment monitoring, since decrease in serum chitotriosidase level can predict favorable treatment response in patients with tuberculosis. Further studies are needed to explore these, and other factors associated with chitotriosidase activity among tuberculosis patients. [ABSTRACT FROM AUTHOR]

Background: Diagnosis and treatment for pharyngeal cancer are decisive in determining prognosis. Diagnosis delays are frequent, representing a significant cause of avoidable mortality, and an important factor in subpar survival across the continuous HNC care delivery. Methods: The present study represents a retrospective analysis of medical records from Western Romania, which included 180 patients, to evaluate the impact of time-to-treatment delay on patients diagnosed with pharyngeal cancer. The data analyses were performed using the Kaplan–Meier method R (version 3.6.3) packages, including tidyverse, final-fit, mcgv, survival, stringdist, janitor, and Hmisc. Results: The mean days from diagnosis until the end of treatment were higher for the nasopharynx group. Cox regression analysis regarding diagnosis to treatment duration categories showed an increased risk mortality by 3.11 times (95%CI: 1.51–6.41, p = 0.0021) with a Harrell's C-index of 0.638 (95%CI: 0.552–0.723). The hypopharynx and oropharynx locations increased risk mortality by 4.59 (95%CI: 1.55–13.55) and 5.49 times (95%CI: 1.79–16.81) compared to the nasopharynx location. Conclusions: The findings of this study led to the conclusion that it seems there is a trend of mortality risk for oropharynx and hypopharynx cancers due to delays in the time to treatment over 70 days, standing as a basis for further research as there is an imperative need for prospective multicenter studies. [ABSTRACT FROM AUTHOR]

Summary: Primary gastric diffuse large B‐cell lymphoma (PG‐DLBCL) accounts for the majority of extra‐nodal DLBCL. Even so, literature is lacking on early, localised presentations. We studied a cohort of patients with stage I disease, diagnosed between 2006 and 2018, from six centres between Australia, Canada and Denmark. Our goal was to characterise outcomes, review treatment and investigate the role of interim positron emission tomography (iPET). Thirty‐seven eligible patients were identified. The median duration of follow‐up was 42.2 months. All received chemoimmunotherapy with 91.9% (n = 34) given rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R‐CHOP). 35.1% (n = 13) underwent consolidative radiotherapy. Eighteen patients were H. pylori positive and 11 had the documentation of H. pylori eradication therapy. The 4‐year progression‐free survival and overall survival of R‐CHOP was 88% (95% CI: 71–95) and 91% (95% CI: 75–97) respectively. All patients who achieved a partial metabolic response or complete metabolic response on iPET went on to achieve complete response at the end of treatment. R‐CHOP‐based therapy with iPET assessment appears to offer favourable outcomes, with radiotherapy and H. pylori eradication therapy implemented on a case‐by‐case basis. [ABSTRACT FROM AUTHOR]

To describe the effects of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg on physical and emotional premenstrual and menstrual symptoms. We used Menstrual Distress Questionnaire (MDQ) data from a phase-3 trial (NCT02817828) in Europe and Russia with participants (18 − 50 years) using E4/DRSP for up to 13 cycles. We assessed mean changes in MDQ-t-scores from baseline to end of treatment in premenstrual (4 days before most recent flow) and menstrual (most recent flow) scores for 4 MDQ domains in starters and switchers (use of hormonal contraception in prior 3 months) and performed a shift analysis on individual symptoms within each domain. Of 1,553 treated participants, 1,398(90.0%), including 531(38%) starters, completed both MDQs. Starters reported improvements for premenstrual Pain (−1.4), Water Retention (−3.3) and Negative Affect (−2.5); and for menstrual Pain (−3.5), Water Retention (−3.4), and Negative Affect (−2.7) (all p < 0.01). For switchers, no changes were significant except an increase in premenstrual (+1.0, p = 0.02) and menstrual (+1.5, p = 0.003) Water Retention. We observed a change in symptom intensity in >40% of participants for Cramps, Backache and Fatigue (domain Pain), Painful or Tender Breast and Swelling (domain Water Retention) and Mood Swings and Irritability (domain Negative Affect). E4/DRSP starters experienced significant improvements in the domains Pain, Water Retention and Negative Affect particularly benefiting those with more severe baseline symptoms. Switchers showed minimal changes. A phase 3 study in Europe and Russia showed that Estetrol/Drospirenone, a new combined oral contraceptive, significantly improved the MDQ scores for domains Pain, Water Retention and Negative Affect in women starting COC use, while switchers showed minimal changes. [ABSTRACT FROM AUTHOR]

Purpose: To compare the effects of doxycycline (DOX) and conventional management in patients with refractory chronic rhinosinusitis and nasal polyps (CRSwNP). Methods: Six databases were searched to September 2023. We retrieved studies that compared improvements in refractory chronic sinusitis-related symptoms between DOX-treated and control groups. Results: DOX significantly reduced the Lund-Kennedy (LK) score [− 0.3670 (range − 0.6173; − 0.1166); I2 = 92.8%], the nasal polyposis score [− 0.9484 (− 1.2287; − 0.6680); I2 = 92.5%], the patient-reported Sinonasal Outcome Test (SNOT) score [− 0.3141 (− 0.4622; − 0.1660); I2 = 91.2%], and the nasal obstruction score [− 0.1813 (− 0.3382; − 0.0243); I2 = 86.2%]. On subgroup analyses by the measurement timepoints, the extent of nasal polyposis was significantly lower in the DOX group during treatment, at the end of treatment, and 4 and 8 weeks later. The LK scores also indicated improvements during treatment and at the end of treatment. The SNOT score tended to decrease with time in the treatment group. Nasal obstruction symptoms improved during treatment and 4 weeks later. Conclusion: DOX enhances the postoperative endoscopic outcomes of refractory CRSwNP patients by reducing recurrent polyposis and inflammation. [ABSTRACT FROM AUTHOR]

Purpose: Hemi-epiphysiodesis procedures in skeletally immature patients are commonly done to correct genu valgum over time. This study seeks to demonstrate the average rate of deformity correction for genu valgum using hinged tension band plates, while examining different age groups and sex-related differences. Methods: A retrospective chart review of patients who underwent hemi-epiphysiodesis with hinged tension band plates for valgus knee deformity from 2012 to 2022 by one pediatric orthopaedic surgeon was performed. Expected time of growth remaining was calculated as the difference between age of skeletal maturity and bone age at time of surgery. The mechanical lateral distal femoral angle, mechanical medial proximal tibial angle, mechanical femoral tibia angle, screw divergence angle, and hinge angle were measured immediately after implant placement and prior to implant removal. Results: 54 skeletally immature patients were treated for pathologic genu valgum. The mean age at time of surgery was 12.5 ± 1.9 years. The radiographic measurement of the valgus deformity between the beginning and end of treatment showed significant correction (p = 0.002). The lower limb axis of the younger cohort corrected significantly faster (7.5 ± 4.6°/year) than the older cohort (5.3 ± 2.8°/year) (p = 0.030). The mechanical lateral distal femoral angle correction rate was also significantly different between the two cohorts (7.0 ± 4.7°/year vs. 4.8 ± 2.8°/year, respectively (p = 0.002)). The group with greater expected time of growth remaining demonstrated a significantly faster rate of correction than the group with less than 2 years of growth remaining (p < 0.001). Conclusion: This study reaffirms the finding that timing is essential when performing temporary hemi-epiphysiodesis for valgus knee deformity in skeletally immature patients. [ABSTRACT FROM AUTHOR]

Health-related quality of life (HRQoL) data are important indicators of health status in patients with lymphoma. The objective of this analysis was to assess the impact of treatment with Sandoz rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) on HRQoL in treatment-naïve adult patients with diffuse large B-cell lymphoma (DLBCL) included in the prospective, real-world REFLECT study. REFLECT is the first prospective study to assess HRQoL in patients with DLBCL treated with a rituximab biosimilar. HRQoL was assessed via the patient-reported European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire at baseline, mid-treatment (month 3), end of treatment (month 6), and follow-up (months 9 and 12). Subgroup analyses were performed to evaluate the influence of baseline characteristics on HRQoL, and associations between baseline HRQoL and treatment response. HRQoL was assessed in 169 patients. Mean global health status score remained stable from baseline (54.8) to mid-treatment (month 3; 54.7), before steadily improving through to end of treatment (month 6; 61.4), and follow-up month 9 (64.9) and month 12 (68.8). Similar trends were observed across most functional and symptom subscales. Higher cognitive, physical, or role functioning, and less appetite loss, diarrhea, fatigue, or pain at baseline, were all associated with an improved likelihood of reaching a complete versus partial response at the end of treatment. Overall, these findings confirm the HRQoL benefits of R-CHOP therapy in treatment-naïve adult patients with DLBCL, and suggest that baseline HRQoL may be predictive of treatment response. [ABSTRACT FROM AUTHOR]

Background: Non-invasive biomarkers have largely replaced liver biopsy in assessment of liver fibrosis in chronic HCV. Autotaxin (ATX) is a novel serum marker that may be related to liver fibrosis. Aim: to clarify the role of ATX as a biomarker for the estimation of hepatic fibrosis and to compare its sensitivity and specificity to the well-known fibrosis-4 score (FIB-4) and the AST-to-Platelet Ratio Index (APRI) before treatment with direct-acting antiviral drugs (DAAs) for chronic HCV as well as six months after the end of treatment. Methods: Plasma samples were obtained from 86 chronic HCV patients with different degrees of liver fibrosis. Routine laboratory, transient elastography (TE) and ultrasonographic assessments were done. Enzyme-linked immunosorbent assay (ELISA) technique was used to detect ATX. Results: ATX, FIB-4, and APRI had AUC of 0.57, 0.95, and 0.92, respectively for the detection of cirrhosis (F4). Baseline ATX was higher in cirrhotic group vs. noncirrhotic group (250 vs. 210) pg/ml, although the difference was not significant (p= 0.3). Significant improvement of all the laboratory parameters, APRI, FIB-4 and liver stiffness occurred at sustained virological response after 24 weeks (SVR24). Nonsignificant increase of ATX level was noted six months after the end of treatment. Conclusion: ATX should be considered cautiously as a diagnostic marker for liver fibrosis in patients with chronic HCV. [ABSTRACT FROM AUTHOR]

Introduction: Rheocarna's therapeutic effect is associated with fibrinogen (Fib) and low‐density lipoprotein cholesterol (LDL‐C) adsorptive removal. This study aimed to retrospectively investigate the association between treatment volume (TV) and circulating blood volume (CBV) and the Fib removal rate (Fib‐RR) and LDL‐C‐RR. Methods: CBV and TV/CBV, cut‐off value (CO value), and area under the receiver operating characteristic (ROC) curve (AUC) were calculated. The Fib‐RR and LDL‐C‐RR at the midterm and end of treatment were compared. The groups were further categorized into three groups with TV/CBV lower than or higher than the CO value at the midterm and end (midterm/end; Group L: lower than/lower than CO; Group L/H: lower than/higher than CO; Group H: higher than/higher than CO), and the Fib‐RR and LDL‐RR of each group at the midterm and end were compared. Results: ROC analysis revealed a TV of 1.480 times the BV as CO value, which showed a maximum Youden index predicting a Fib‐RR of 20% (AUC: 0.828). Among the three groups, Group L and Group L/H demonstrated significantly higher Fib‐RR and LDL‐C‐RR at the end of the study than in the midterm, while Group H exhibited no difference. Conclusion: The results reveal that a treatment volume of 1.5 times the circulating blood volume is a sufficient solute removal capacity in the Rheocarna‐enabled cases. [ABSTRACT FROM AUTHOR]

Disruptive behavior disorders (DBDs) are common mental health problems among early childhood American youth that, if poorly managed, pose costly psychological and societal burdens. There is limited real world evidence on how parent management training (PMT) – the evidence-based treatment model of choice – implemented in common practice settings within the United States influences the behavioral progress of early childhood DBDs, and the risk factors associated with poor outcomes. This study used data from a measurement feedback system implemented within a U.S.-based private practice to study how behavioral outcomes change as a function of PMT treatment engagement and associated risk factors for 4–7 year-old children diagnosed with DBDs. Over 50% of patients reached optimal outcomes after 10 appointments. Attending 24–29 appointments provided maximum treatment effect – namely, 75% of patients reaching optimal outcomes by end of treatment. Outcomes attenuate after reaching the maximum effect. Patients also had higher odds of reaching optimal outcomes if they had consistent attendance throughout the treatment course. Notable risk factors associated with lower odds of reaching optimal outcomes included Medicaid insurance-type, greater clinical complexity, and having siblings concurrently in treatment. Increased implementation of systems that monitor and provide feedback on treatment outcomes in U.S.-based practice settings and similar investigations using its data can further enhance 'real world' management of early childhood DBDs among American youth. [ABSTRACT FROM AUTHOR]

(1) Background: Previous studies, mostly performed in European centers, have shown that in-patient multimodal intensive rehabilitation treatments lasting for two to four weeks can improve both motor and non-motor symptoms of Parkinson's disease (PD) with long-lasting effects. Here, we ascertain the effects of a similar in-patient program in a U.S. center with a retrospective study in a cohort of 153 patients in the moderately advanced stage of PD. (2) Methods: We compared indices of motor and non-motor functions before and immediately after such treatment and investigated the possible differences between men and women. We used the available records of the Beck Depression Inventory, PDQ39, PD Sleep Scale, Timed Up and Go, Vocal Volume, Voice Handicap, and total UPDRS scores. (3) Results: We found that at the end of treatment, which lasted an average of 14 days, all outcome measures significantly improved independently of sex. (4) Conclusions: These results confirm the previous findings with a similar in-patient approach in European centers. They further suggest that this in-patient treatment is a care model that is feasible in U.S. centers and can provide a more immediate benefit to the motor function and quality of life of patients with moderately advanced PD. [ABSTRACT FROM AUTHOR]

The oral microbiome is a diverse and complex ecosystem essential for maintaining oral and systemic health. Our study is the first to define the oral microbial community in Egyptian young adults and investigate the effects of natural antimicrobials on the oral microbiome. SuperMint (SM) is a proprietary blend of peppermint, Japanese mint, bergamot mint, and spearmint essential oils encapsulated in a tiny soft beadlet. This work aimed to evaluate the effects of SM beadlets on the oral microbiome. This study recruited twenty healthy participants. A baseline investigation of the oral microbiome of the selected participants was performed by collecting saliva and swab samples before treatment. Treatment included chewing four SM beadlets twice a day for 7 days, and then, post-administration saliva and swab samples were collected at the end of treatment. The oral microbiome samples were analyzed by the high-throughput amplicon sequencing of 16S rRNA gene fragments, and the community composition was determined. The results showed that the abundance of some microbial genera and families decreased after using SM, including Prevotella, Streptococcus, Neisseria, and Haemophilus. However, some genera showed inconsistent patterns. We also found that the subject's gender and SM usage were significantly associated with diverse microbial composition. The results suggest that SM treatment decreased the abundance of several bacteria associated with halitosis and periodontal diseases, such as Actinomyces and Streptococcus. Furthermore, Corynebacterium species increased and Streptococcus decreased after SM usage. More research is needed to fully understand the antimicrobial effects of mint oils and their potential applications in maintaining good oral health. [ABSTRACT FROM AUTHOR]

In this paper, we discuss the effect of optimal chemotherapy doses on solid tumor during treatment and cancer recurrence after the end of treatment. First, an optimal control problem is designed. Then, by changing the control range, the objective function, and adding a control to the previous problem, three new optimal control problems are constructed. We pursue two critical ideas for the success of the drug delivery system to the patient: minimizing the normalized global population density of cancer cells during treatment and at the end of treatment and minimizing side effects during treatment. The optimal control problem is considered with two linear and quadratic objective functions. These models are solved by a well‐established numerical method with high accuracy and a low discretization cost. The numerical results have confirmed that reducing the total dose of the cytotoxic drugs during the treatment period leads to a rapid recurrence of cancer shortly after the end of the treatment period. [ABSTRACT FROM AUTHOR]

AbstractObjectiveMethodsResultsConclusionAmong postmenopausal women, oral, ultra-low-dose continuous combined estradiol (E0.5 mg) plus dydrogesterone (D2.5 mg) reduces vasomotor symptoms (VMS).This study was a post hoc analysis of data from two phase 3, double-blind studies. Postmenopausal women were randomized 2:1:2 to receive E0.5 mg/D2.5 mg, E1 mg/D5 mg (not included in this analysis) or placebo for 13 weeks (European study), or randomized 1:1 to receive E0.5 mg/D2.5 mg or placebo for 12 weeks (Chinese study). Endpoints assessed in ethnicity subgroups (European and Chinese) included changes from baseline in number of hot flushes, number of moderate-to-severe hot flushes and Menopause Rating Scale (MRS) score.Overall, 579 women were included in the analysis (E0.5 mg/D2.5 mg, n = 288; placebo, n = 291). European and Chinese women receiving E0.5 mg/D2.5 mg experienced greater reductions from baseline in mean daily number of hot flushes and mean daily number of moderate-to-severe hot flushes at week 4, week 8 and end of treatment versus those receiving placebo. Significant improvements in the ‘hot flushes, sweating’ MRS item score were reported in both European and Chinese women.Oral, ultra-low-dose continuous combined 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone improved VMS compared with placebo in European and Chinese postmenopausal women, with a positive impact on health-related quality of life. [ABSTRACT FROM AUTHOR]

Background: The treatment of stage I-III HPV+ oropharyngeal squamous cell carcinoma (HPV-OPSCC) is based on either surgery ± adjuvant therapy or exclusive radio±chemotherapy. We sought to compare these two therapeutic strategies in terms of efficacy, tolerance and quality of life (QoL). Methods: Patients treated for stage I-III HPV-OPSCC from 2010 to 2021 in 3 academic centers were included and sorted according to the treatment strategy: surgery or exclusive radio±chemotherapy. Efficacy and tolerance were retrospectively assessed, and a transversal exploratory QoL assessment was performed using QoL instruments. Results: A total of 83 patients were included, with 21 undergoing non-minimally invasive surgery and 62 receiving definitive radio-±chemotherapy. 2-year progression-free survival (PFS) and overall survival (OS) were respectively 80% and 86% in the surgical group and 92% and 95% in the non-surgical group, with no significant difference. At the end of treatment, 64.5% of patients presented with a grade III toxicity, without significant difference between the two groups. No patient had late grade III toxicity at 24 months. Forty-five patients (11 in the surgical group, 34 in the non-surgical group) participated in an exploratory quality-of-life analysis. Patients reported significantly more fatigue and loss of appetite after surgery, whereas patients in the radio±chemotherapy group described significantly more salivary and oral problems and difficulty swallowing, but the median time between treatment completion and the response to the questionnaires. Conclusion: There was no significant difference in efficacy, physician-reported toxicity and overall patient-reported quality of life was found between non-minimally invasive surgery and radio±chemotherapy in the treatment of stage I-III HPV-OPSCC. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective Methods Results Discussion Trial Registration To systematically review and evaluate the efficacy of eating disorder focused family therapy (FT‐ED) in comparison to all other forms of psychotherapy for children and adolescents with anorexia nervosa. A secondary aim is to assess the relative efficacy of different variations of FT‐ED (e.g., shorter vs. longer dose, parent‐focused).A search with relevant terms was systematically conducted on four databases. Twenty‐three publications across 18 randomized controlled trials met inclusion criteria. Outcomes of interest included variables related to weight, eating psychopathology, and remission status. Study quality was assessed, and data were extracted by two independent researchers.Adolescents receiving FT‐ED gained significantly more weight by the end of treatment in comparison to those receiving individual psychotherapy. FT‐ED that was delivered just to parents or to parents and child separately offered preferable weight outcomes and rates of recovery at the end of treatment in comparison to conjoint FT‐ED. No other outcomes tested in the meta‐analysis were statistically significant at the end of treatment or follow‐up.Currently available data suggest the use of FT‐ED in its conjoint or separated/parent focused format is the best outpatient treatment option for adolescents with anorexia nervosa when immediate weight gain is paramount. The variability of outcome measurement, including the tools used and timepoints chosen, limit comparison among no more than a handful of studies. The field would benefit from the standardization of measurement and reporting guidelines for future clinical trials.PROSPERO number: CRD42023396263. [ABSTRACT FROM AUTHOR]

Background: Tuberculosis (TB) lymphadenitis is the most common form of extra-pulmonary TB, and the treatment duration is six months. This non-inferiority based randomized clinical trial in South India evaluated the efficacy and safety of a four-month ofloxacin containing regimen in tuberculosis lymphadenitis (TBL) patients. Methods: New, adult, HIV-negative, microbiologically and or histopathologically confirmed superficial lymph node TB patients were randomized to either four-month oflaxacin containing test regimen [ofloxacin (O), isoniazid (H), rifampicin (R), pyrazinamide (Z) -2RHZO daily/ 2RHO thrice-weekly] or a six-month thrice-weekly control regimen (2HRZ, ethambutol/4RH). The treatment was directly observed. Clinical progress was monitored monthly during and up to 12 months post-treatment, and thereafter every three months up to 24 months. The primary outcome was determined by response at the end of treatment and TB recurrence during the 24 months post-treatment. Results: Of the 302 patients randomized, 298 (98.7%) were eligible for modified intention-to-treat (ITT) analysis and 294 (97%) for per-protocol (PP) analysis. The TB recurrence-free favourable response in the PP analysis was 94.0% (95% CI: 90.1–97.8) and 94.5% (95% CI: 90.8–98.2) in the test and control regimen respectively, while in the ITT analysis, it was 92.7% and 93.2%. The TB recurrence-free favourable response in the test regimen was non-inferior to the control regimen 0.5% (95% CI: -4.8-5.9) in the PP analysis based on the 6% non-inferiority margin. Treatment was modified for drug toxicity in two patients in the test regimen, while one patient had a paradoxical reaction. Conclusion: The 4-month ofloxacin containing regimen was found to be non-inferior and as safe as the 6-month thrice-weekly control regimen. [ABSTRACT FROM AUTHOR]

Background: Cervical cancers are mainly caused by an oncogenic HPV. For locally advanced stages, the standard treatment is radio-chemotherapy (RTCT) followed by brachytherapy. Nevertheless, the prognosis remains highly heterogeneous between patients. Objective: We investigated the prognostic value of HPV circulating tumor DNA (ctDNA) in locally advanced cervical cancers alongside that of Squamous Cell Carcinoma Antigen (SCC-A). Methods: This single-center retrospective study included patients treated in curative intent for an IB3 to IVA squamous cell cervical cancer. Quantification of HPV ctDNA in serum collected at diagnosis was performed using a multiplex digital PCR assay for the simultaneous detection of 8 HPV genotypes. Results: Among the 97 patients included, 76 patients (78.4%) were treated by RTCT, followed by brachytherapy for 57 patients (60%). HPV ctDNA was detected in 59/97 patients at diagnosis (60.8%). This detection was associated with lymph node invasion (p=0.04) but not with tumor stage. A high level of SCC-A at diagnosis was associated with tumor stage (p=0.008) and lymph node invasion (p=0.012). In univariate analysis, better disease-free survival (DFS) was associated with optimal RTCT regimen (p=0.002), exposure to brachytherapy (p=0.0001) and a low SCC-A at diagnosis (continuous analysis, p=0.002). Exploratory analysis revealed that 3/3 patients (100%) whose HPV ctDNA was still detectable at the end of treatment relapsed, while 6/22 patients (27.3%) whose HPV ctDNA was negative at the end of treatment relapsed. Conclusion: HPV ctDNA detection at diagnosis of locally advanced cervical squamous cell carcinomas is frequent and related to node invasion, but not to DFS. The prognostic value of HPV ctDNA detection after treatment warrants specific studies. [ABSTRACT FROM AUTHOR]

Introduction: Chronic hepatitis B (CHB) is a worldwide infectious disease caused by hepatitis B virus (HBV). Optimizing antiviral treatment strategies could improve the functional cure (FC) rate of patients with CHB. This study aims to systematically review the FC rate of the de novo combination of nucleos(t)ide analogs (NAs) and pegylated interferon a (PEG-IFNa) versus that of PEG-IFNa monotherapy for CHB. Methods: Databases were searched until 31 December 2023. Selected studies included randomized controlled trials on the de novo combination of NAs and PEG-IFNa versus PEG-IFNa monotherapy for 48 weeks in patients with CHB to achieve FC, which was defined as hepatitis B surface antigen (HBsAg) loss and/or HBsAg seroconversion. Meta-analysis was conducted in accordance with the efficacy at the end of treatment and different time points during follow-up. Results: A total of 10 studies, encompassing 2,339 patients in total, were included. Subgroup analysis was conducted in accordance with whether first-line NAs were used. It found no statistically significant difference between HBsAg loss and HBsAg seroconversion at the end of treatment. Serum HBV DNA <500 copies/mL significantly differed between the two groups at the end of treatment and did not significantly differ during follow-up. Meanwhile, HBsAg loss and HBsAg seroconversion showed statistically significant differences at 24 weeks of follow-up. By contrast, no statistically significant difference was found in HBsAg loss at 48 weeks of follow-up. Discussion: Without distinguishing the eligible preponderant population, the efficacy of the de novo combination of NAs and PEG-IFNa in treating patients with CHB was not superior to that of PEG-IFNa monotherapy. [ABSTRACT FROM AUTHOR]

Summary: Background: Sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) is the recommended rescue therapy for patients with chronic hepatitis C infection who fail direct‐acting antivirals (DAAs). Data are limited on the effectiveness of this treatment after the current first‐line therapies. Our aim was to analyse the effectiveness and safety of SOF/VEL/VOX among patients failing sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB). Methods: Retrospective multicentre study (26 Spanish hospitals), including chronic hepatitis C patients unsuccessfully treated with SOF/VEL or GLE/PIB, and retreated with SOF/VEL/VOX ± ribavirin for 12 weeks between December 2017 and December 2022. Results: In total, 142 patients included: 100 (70.4%) had failed SOF/VEL and 42 (29.6%) GLE/PIB. Patients were mainly men (84.5%), White (93.9%), with hepatitis C virus genotype (GT) 3 (49.6%) and 47.2% had liver cirrhosis. Sustained virological response (SVR) was evaluated in 132 patients who completed SOF/VEL/VOX and were followed 12 weeks after end of treatment; 117 (88.6%) achieved SVR. There were no significant differences in SVR rates according to initial DAA treatment (SOF/VEL 87.9% vs. GLE/PIB 90.2%, p = 0.8), cirrhosis (no cirrhosis 90% vs. cirrhosis 87.1%, p = 0.6) or GT3 infection (non‐GT3 91.9% vs. GT3 85.5%, p = 0.3). However, when considering the concurrent presence of SOF/VEL treatment, cirrhosis and GT3 infection, SVR rates dropped to 82.8%. Ribavirin was added in 8 (6%) patients, all achieved SVR. Conclusion: SOF/VEL/VOX is an effective rescue therapy for failures to SOF/VEL or GLE/PIB, with an SVR of 88.6%. Factors previously linked to lower SVR rates, such as GT3 infection, cirrhosis and first‐line therapy with SOF/VEL were not associated with lower SVRs. [ABSTRACT FROM AUTHOR]

Background: By encouraging treatment adherence and lowering mortality, dietary supplements can serve as adjuvant therapy for the success of medical interventions. We determined the effect of locally accessible food supplements on treatment outcomes, and health-related quality of life in patients with pulmonary tuberculosis initiating anti-tuberculosis treatment (ATT) in Odisha, India. Method: Between September 2017 and December 2018, implementation research in patients with newly diagnosed sputum smear-positive pulmonary tuberculosis initiating ATT in five districts of the tribal belt of Odisha, offered food supplements along with ATT in a phased manner. Clinical symptoms, anthropometry, sputum for M. tuberculosis (M. tb), health-related quality of life and return to normal function were assessed periodically, and favourable treatment outcome (cure or treatment completed) was measured at the end of treatment. The effect of the food supplement on unfavorable outcomes (treatment failure, death, or lost-to-follow-up) was modelled using mixed-effects Poisson regression to determine the risk factors. Results: Among the 761 participants enrolled, 614 participants received the food supplement and 147 did not receive the food supplement. Among the 614 participants in the supplement group, 537 (87%) had a favorable outcome and among the 147 participants in the no-supplement group, 113 (77%) had a favorable outcome (p = 0.0017). Higher age (>55 years) [aRR = 2.1(95% CI: 1.1–3.8)], male gender [aRR = 1.7(95% CI: 1.2–2.9)], and smear grading ≥2+ [aRR = 1.5 (95% CI: 1.1–2.2)] were associated with unfavorable treatment outcomes. Nutritional status, quality of life and lung health showed significant improvement from baseline in the supplement group. Conclusion: Improvement in the nutritional status of the patient can be considered a predictor of treatment success rates. Early food supplementation has a positive impact on the nutritional status. [ABSTRACT FROM AUTHOR]

Background and Aims Methods Results Conclusions Accurate biomarkers to predict outcomes following discontinuation of nucleos(t)ide analogue (NA) therapy are needed. We evaluated serum hepatitis B core‐related antigen (HBcrAg) level as a biomarker for predicting outcomes after NA discontinuation.Patients with HBeAg‐negative chronic hepatitis B (CHB) without cirrhosis were enrolled in a prospective trial evaluating clinical outcomes until 96 weeks after NA discontinuation. End of treatment (EOT) and off‐treatment levels of serum HBcrAg, HBsAg, HBV RNA and HBV DNA were used to predict key clinical outcomes including hepatitis flare (ALT ≥5 × ULN and HBV DNA > 2000 IU/mL). The SCALE‐B score was calculated for the purposes of model validation.HBcrAg was tested amongst 65 participants. The median age was 54 years, 54% were male and 83% were Asian. HBcrAg was detectable in 86% patients. HBcrAg level ≥4 log U/mL at EOT was predictive of hepatitis flare [8/10 (80%) vs. 17/55 (31%), p = .001]. The presence of either HBcrAg ≥4 log U/mL or detectable HBV RNA at EOT predicted for both biochemical relapse and hepatitis flare. The SCALE‐B model at EOT predicted for virological relapse, biochemical relapse, hepatitis flare and HBsAg loss in this cohort. An increase in the serum HBcrAg level off‐treatment was also associated with hepatitis flare. No participant with EOT HBcrAg level ≥4 log U/mL achieved HBsAg loss.High levels of serum HBcrAg predict for hepatitis flare after stopping NA therapy and low likelihood of HBsAg loss at week 96. People with high levels of serum HBcrAg are not suitable candidates for NA discontinuation. [ABSTRACT FROM AUTHOR]

Objectives Methods Results Conclusion We aimed to assess the effectiveness of the use of topical imiquimod for the management of oral leukoplakia (OL).This was a retrospective study. Medical chart reviews were conducted to identify patients with biopsy‐proven OL treated with topical 5% imiquimod. Data included OL characteristics, histopathological diagnosis, treatment outcome, and adverse events (AEs). Treatment response was assessed by measuring the percentage reduction in the size of OL lesions.33 patients (51.5% females; median age: 65 years) with 38 lesions were included. OLs were either localized (23.7%) or multifocal lesions (76.3%), with the majority on the gingiva (86.8%). Pretreatment histopathological diagnoses were dysplasia in 84.2% and nonreactive hyperkeratosis in 15.8%. Most regimens consisted of 60‐minute applications, 5‐days‐a‐week, for 6 weeks. At the end of treatment, 81.6% of 38 lesions showed a reduction in size with 68.4% exhibiting ≥50% reduction in size, and 42.1% exhibiting complete resolution. Application site reactions were the most common with pain/soreness/sensitivity occurring in 86.8%. Fatigue was the most frequently reported systemic AE (28.9%).Two‐thirds of OL lesions had ≥50% reduction in size. Most AEs were temporary and resolved upon treatment discontinuation. Prospective studies are needed to further assess Imiquimod's effectiveness in OL management. [ABSTRACT FROM AUTHOR]

Background: We aimed to assess serum 25-hydroxyvitamin D3 (25(OH)D3) concentrations in extrapulmonary tuberculosis (EPTB) patients and to evaluate the effect of vitamin D3 supplementation on their treatment course. Methods: Serum 25(OH)D3concentrations were measured in 47 newly diagnosed EPTB patients and 42 controls. Vitamin D-deficient EPTB patients were randomly assigned to receive 50,000 IU of vitamin D3 (cholecalciferol) orally once a week for 6 weeks (total 300,000 IU), followed by maintenance doses of 1000 IU a day besides anti-TB drugs or the first line anti-TB treatment only. Follow up serum 25(OH)D3 concentrations were measured after 3 months of starting vitamin D3 supplementation. Both groups were evaluated for clinical, laboratory, and radiological outcomes after treatment. Results: Serum 25(OH)D3 concentrations were significantly lower among TB cases (17.1 ± 5.5 nmol/L) compared to healthy controls (51.8 ± 27.3 nmol/L), and vitamin D deficiency was observed in all EPTB patients (n = 47). Patients in VD3 supplementation group had significantly higher weight gain and serum albumin level at 2 months and end of treatment, higher hemoglobin concentration at the end of treatment, significantly lower CRP and ESR at 2 months and at the end of treatment. In cases with TB pleurisy, a significant higher rate of full resolution of pleural fluid after 6 months of anti-TB treatment and shorter treatment duration were noted compared to the other group. Conclusions: Vitamin D deficiency is prevalent in EPTB patients, in whom, vitamin D supplementation is a useful adjunctive therapy to anti-TB drugs and improves treatment course. [ABSTRACT FROM AUTHOR]

BACKGROUND In a phase 3 trial, bulevirtide monotherapy led to a virologie response in patients with chronic hepatitis D. Pegylated interferon (peginterferon) alfa-2a is recommended by guidelines as an off-label treatment for this disease. The role of combination therapy with bulevirtide and peginterferon alfa-2a, particularly with regard to finite treatment, is unclear. METHODS In this phase 2b, open-label trial, we randomly assigned patients to receive peginterferon alfa-2a alone (180 jxg per week) for 48 weeks; bulevirtide at a daily dose of 2 mg or 10 mg plus peginterferon alfa-2a (180 jig per week) for 48 weeks, followed by the same daily dose of bulevirtide for 48 weeks; or bulevirtide at a daily dose of 10 mg alone for 96 weeks. All the patients were followed for 48 weeks after the end of treatment. The primary end point was an undetectable level of hepatitis D virus (HDV) RNA at 24 weeks after the end of treatment. The primary comparison was between the 10-mg bulevirtide plus peginterferon alfa-2a group and the 10-mg bulevirtide monotherapy group. RESULTS A total of 24 patients received peginterferon alfa-2a alone, 50 received 2 mg and 50 received 10 mg of bulevirtide plus peginterferon alfa-2a, and 50 received 10 mg of bulevirtide monotherapy. At 24 weeks after the end of treatment, HDV RNA was undetectable in 17% of the patients in the peginterferon alfa-2a group, in 32% of those in the 2-mg bulevirtide plus peginterferon alfa-2a group, in 46% of those in the 10-mg bulevirtide plus peginterferon alfa-2a group, and in 12% of those in the 10-mg bulevirtide group. For the primary comparison, the between-group difference was 34 percentage points (95% confidence interval, 15 to 50; P<0.001). At 48 weeks after the end of treatment, HDV RNA was undetectable in 25% of the patients in the peginterferon alfa-2a group, in 26% of those in the 2-mg bulevirtide plus peginterferon alfa-2a group, in 46% of those in the 10-mg bulevirtide plus peginterferon alfa-2a group, and in 12% of those in the 10-mg bulevirtide group. The most frequent adverse events were leukopenia, neutropenia, and thrombocytopenia. The majority of adverse events were of grade 1 or 2 in severity. CONCLUSIONS The combination of 10-mg bulevirtide plus peginterferon alfa-2a was superior to bulevirtide monotherapy with regard to an undetectable HDV RNA level at 24 weeks after the end of treatment. [ABSTRACT FROM AUTHOR]

Introduction: Feline Infectious Peritonitis (FIP) has historically been a fatal coronavirus disease in cats. In recent years, the therapeutic agent GS-441524, developed by Gilead Sciences, was found to be a successful treatment for FIP in most patients in clinical trials. However, this particular drug has remained stalled in the therapeutic pipeline, leaving patients and cat owners without a licensed medication. In the meantime, online social media platforms began to emerge, connecting cat owners with a community of citizen non-veterinary professionals sourcing unlicensed GS-441524. Methods: This study prospectively followed participants (N  =  141) that successfully completed 12 weeks of treatment, capturing their treatment experiences with self-administered GS-441524-like medication. A one-time survey was administered to enrolled participants with mixed format of questions (open-ended and multiple-choice) asking about treatment administration techniques, observed side effects of GS-441524, accrued cost, veterinarian involvement, impact on the cat-human bond, and social media usage. Results: Our results show cat owners experienced a shift in treatment modality from injectable GS-441524 to pill formulation across the treatment period. The average total cost of medication has decreased since 2021 to approximately USD 3100, and participants reported the human–animal bond being affected negatively. Additionally, there was an increased trend in veterinarian awareness of GS-441524-like therapeutics and monitoring of clients undergoing treatment. Social media usage was reported as being important at the beginning of treatment to establish treatment administration but lessened by the end of treatment. Discussion: This study is the first detailed, prospective account of owner experiences with unlicensed GS-441524, raising an important discussion surrounding citizen veterinary medicine. [ABSTRACT FROM AUTHOR]

Background: Sexuality and gender minoritised (SGM) adolescents are at increased risk of self-injury and suicide, and experience barriers to accessing mental health support. Dialectical behaviour therapy (DBT) is an effective treatment for self-injury and emotion dysregulation in adolescent populations, but few studies have published outcomes of DBT for SGM young people. Aims: This study aimed to investigate treatment outcomes and completion for SGM adolescents and their cisgender and heterosexual peers, in the National & Specialist CAMHS, DBT service (UK). Method: Treatment completion, and opting out before and during treatment were examined for sexual and gender identity groups, as well as changes by the end of treatment in emotion dysregulation, self-injury, in-patient bed-days, emergency department attendances, and borderline personality disorder, depression and anxiety symptoms. Results: SGM adolescents were over-represented in this service, even after considering their increased risk for self-injury. No statistically significant differences were found for treatment completion between the sexual orientation and gender identity groups, although there were patterns indicating possible lower treatment uptake and completion that warrant further investigation. Clinical outcomes for treatment-completers showed improvement by the end of DBT for each group, with few exceptions. Discussion: These results are from relatively small subsamples, and it was not possible to separate by sex assigned at birth. Findings should be treated tentatively and as early indications of effect sizes to inform future studies. This study suggests that DBT could be a useful treatment for SGM adolescents in a highly specialist treatment setting. [ABSTRACT FROM AUTHOR]

Negative posttraumatic cognitions (NPCs) have been linked to symptoms of PTSD and are an important target of cognitive behavioral treatments for PTSD, including Cognitive Processing Therapy (CPT). Yet to be explored are the different change trajectories of NPCs during CPT. Knowledge of such change trajectories could elucidate common NPC change processes within CPT and their relationship to PTSD symptom severity. We examined NPC change trajectories in a group of 443 veterans who completed a 2-week intensive CPT program. We identified four NPC trajectory groups termed start high end high, start high end moderate, start moderate end low, and start low end low. Most of the groups showed an increase in NPCs at the midpoint of treatment before ultimately decreasing. As predicted, baseline PTSD symptom severity predicted change trajectory group membership. Also, NPC change trajectories were associated with PTSD severity at the end of treatment such that individuals in smaller NPC change groups had higher PTSD symptoms at the end of treatment, and vice versa. Clinicians can use this knowledge to make predictions of a particular client's NPC change trajectory and set expectations for what progress in treatment may look like, including normalizing increases in NPCs from the start of treatment. [ABSTRACT FROM AUTHOR]

Background: Subclinical involvement of nerves may sometimes be present much before the overt clinical manifestations become apparent. Protein gene product (PGP) 9.5, a ubiquitin‑C‑terminal hydrolase, has been widely used as a marker to study the involvement of peripheral nerve fibers in many diseases. Aim and Objectives: To evaluate the change in cutaneous nerve fiber staining and distribution from pre‑treatment and post completion of multidrug therapy through the expression of PGP9.5 and to assess PGP9.5 as a marker of treatment response. Materials and Methods: In this prospective single‑center observational study, skin biopsy was taken in patients with leprosy, having areas of nerve function impairment (NFI), based on findings of nerve conduction studies (NCSs), but not having lesions or impaired tactile or thermal impairment clinically. The thin nerve fiber density in the clinically normal skin in areas supplied by nerve showing changes of sensory neuropathy was evaluated to study the density of the fibers. A second biopsy was taken at the end of treatment from a site near the previous site to assess the changes in intra‑epidermal nerve fiber staining and distribution. Results: Thirty‑three patients were recruited in the present study (24 males and 9 females). Pre‑treatment, 27 patients had abnormal NCSs, while six patients did not have any evidence of neuropathy on NCSs. Staining for nerve fibers using PGP9.5; in the epidermis was positive in five patients pre‑treatment and 11 patients post treatment (P = 0.181). Staining in the dermis revealed positivity in 14 pre‑treatment, which increased to 18 post treatment (P = 0.342). Adnexae showed positivity in five patients pre‑treatment and increased to 17 post treatment (P = 0.005). Conclusion: A reduced PGP9.5 staining in the epidermal, dermal, and adnexal regions was seen in leprosy patients, which improved post treatment. Thus, PGP9.5 may serve as a marker of NFI and treatment response. [ABSTRACT FROM AUTHOR]