bluuebunny/crossref_metadata_2025_split huggingface dataset:
Smartwatch-Detected Arrhythmias in Patients After Transcatheter Aortic Valve Replacement (TAVR): Analysis of the SMART TAVR Trial
Authors: Fan Jiaqi , Dai Hanyi , Guo Yuchao , Xu Jianguo , Wang Lihan , Jiang Jubo , Lin Xinping , Li Cheng , Zhou Dao , Li Huajun , Liu Xianbao , Wang Jian'an 
Published: July 2024

Background
There are limited data available on the development of arrhythmias in patients at risk of high-degree atrioventricular block (HAVB) or complete heart block (CHB) following transcatheter aortic valve replacement (TAVR).

Objective
This study aimed to explore the incidence and evolution of arrhythmias by monitoring patients at risk of HAVB or CHB after TAVR using smartwatches.

Methods
We analyzed 188 consecutive patients in the prospective SMART TAVR (smartwatch-facilitated early discharge in patients undergoing TAVR) trial. Patients were divided into 2 groups according to the risk of HAVB or CHB. Patients were required to trigger a single-lead electrocardiogram (ECG) recording and send it to the Heart Health App via their smartphone. Physicians in the central ECG core lab would then analyze the ECG. The incidence and timing of arrhythmias and pacemaker implantation within a 30-day follow-up were compared. All arrhythmic events were adjudicated in a central ECG core lab.

Results
The mean age of the patients was 73.1 (SD 7.3) years, of whom 105 (55.9%) were men. The mean discharge day after TAVR was 2.0 (SD 1.8) days. There were no statistically significant changes in the evolution of atrial fibrillation or atrial flutter, Mobitz I, Mobitz II, and third-degree atrial ventricular block over time in the first month after TAVR. The incidence of the left bundle branch block (LBBB) increased in the first week and decreased in the subsequent 3 weeks significantly (P<.001). Patients at higher risk of HAVB or CHB received more pacemaker implantation after discharge (n=8, 9.6% vs n=2, 1.9%; P=.04). The incidence of LBBB was higher in the group with higher HAVB or CHB risk (n=47, 56.6% vs n=34, 32.4%; P=.001). The independent predictors for pacemaker implantation were age, baseline atrial fibrillation, baseline right bundle branch block, Mobitz II, and third-degree atrioventricular block detected by the smartwatch.

Conclusions
Except for LBBB, no change in arrhythmias was observed over time in the first month after TAVR. A higher incidence of pacemaker implantation after discharge was observed in patients at risk of HAVB or CHB. However, Mobitz II and third-degree atrioventricular block detected by the smartwatch during follow-ups were more valuable indicators to predict pacemaker implantation after discharge from the index TAVR.

Trial Registration
ClinicalTrials.gov NCT04454177; https://clinicaltrials.gov/study/NCT04454177
Feuerstein Instrumental Enrichment Program for People With Schizophrenia After the First Episode of Psychosis: Protocol for an Open-Label Intervention Study
Authors: Fonseca Ana Olivia , Gomes July Silveira , Novaes Rafael Angulo Condoretti Barros , Dias Cíntia Lopes , Rodrigues Maria Eva de Miranda Alves , Gadelha Ary , Noto Cristiano 
Published: July 2024

Background
Schizophrenia is a disorder associated with neurocognitive deficits that adversely affect daily functioning and impose an economic burden. Cognitive rehabilitation interventions, particularly during the early phases of illness, have been shown to improve cognition, functionality, and quality of life. The Feuerstein Instrumental Enrichment (FIE) program, based on the Mediated Learning Experience and the Structural Cognitive Modifiability theory, has been applied in various disorders, but its applicability in schizophrenia has not yet been clarified.

Objective
This study aims to investigate the effects of the FIE program on the functionality of patients with first-episode schizophrenia.

Methods
In total, 17 patients will be recruited for an open-label intervention consisting of twice-weekly sessions for 10 weeks. The primary outcome measure will be changes in the Goal Achievement Scale score. Maze task performance from the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery will serve as a secondary outcome measure. At the same time, changes in Positive and Negative Syndrome Scale scores and other MATRICS domains will be analyzed as exploratory outcomes. Assessments will be administered before and after the intervention, with a follow-up period of 6 months.

Results
This trial was preregistered in The Brazilian Registry of Clinical Trials (RBR-4gzhy4s). By February 2024, 11 participants were enrolled in the training. Recruitment is expected to be completed by May 2024. Data analysis will be conducted between May and September 2024. The results are expected to be published in January 2025.

Conclusions
This study may establish a protocol for the FIE program that uses mediation techniques for individuals in the early stages of schizophrenia. The results will add to the knowledge about strategies to promote cognitive skills and functional impairment in daily life.

International Registered Report Identifier (IRRID)
DERR1-10.2196/57031
Impact of Consumer Wearables Data on Pediatric Surgery Clinicians’ Management: Multi-Institutional Scenario-Based Usability Study
Authors: Carter Michela , Linton Samuel C , Zeineddin Suhail , Pitt J Benjamin , De Boer Christopher , Figueroa Angie , Gosain Ankush , Lanning David , Lesher Aaron , Islam Saleem , Sathya Chethan , Holl Jane L , Ghomrawi Hassan MK , Abdullah Fizan 
Published: July 2024

Background
At present, parents lack objective methods to evaluate their child’s postoperative recovery following discharge from the hospital. As a result, clinicians are dependent upon a parent’s subjective assessment of the child’s health status and the child’s ability to communicate their symptoms. This subjective nature of home monitoring contributes to unnecessary emergency department (ED) use as well as delays in treatment. However, the integration of data remotely collected using a consumer wearable device has the potential to provide clinicians with objective metrics for postoperative patients to facilitate informed longitudinal, remote assessment.

Objective
This multi-institutional study aimed to evaluate the impact of adding actual and simulated objective recovery data that were collected remotely using a consumer wearable device to simulated postoperative telephone encounters on clinicians’ management.

Methods
In total, 3 simulated telephone scenarios of patients after an appendectomy were presented to clinicians at 5 children’s hospitals. Each scenario was then supplemented with wearable data concerning or reassuring against a postoperative complication. Clinicians rated their likelihood of ED referral before and after the addition of wearable data to evaluate if it changed their recommendation. Clinicians reported confidence in their decision-making.

Results
In total, 34 clinicians participated. Compared with the scenario alone, the addition of reassuring wearable data resulted in a decreased likelihood of ED referral for all 3 scenarios (P<.01). When presented with concerning wearable data, there was an increased likelihood of ED referral for 1 of 3 scenarios (P=.72, P=.17, and P<.001). At the institutional level, there was no difference between the 5 institutions in how the wearable data changed the likelihood of ED referral for all 3 scenarios. With the addition of wearable data, 76% (19/25) to 88% (21/24 and 22/25) of clinicians reported increased confidence in their recommendations.

Conclusions
The addition of wearable data to simulated telephone scenarios for postdischarge patients who underwent pediatric surgery impacted clinicians’ remote patient management at 5 pediatric institutions and increased clinician confidence. Wearable devices are capable of providing real-time measures of recovery, which can be used as a postoperative monitoring tool to reduce delays in care and avoidable health care use.
Assessment of haematological parameters in HIV patients attending Kabutare district Hospital
Authors: Emmanuel NTIVUGURUZWA , ALAIN PRUDENCE ISHIMWE , Danny UFITEYEZU Pierre , Yoranda IMURINDE , Athanasie UWIRINGIYIMANA 
Published: July 2024

Background: Human Immunodeficiency virus (HIV) infection is characterized by progressive weakening of the immune system attributed to the decrease in the number of circulating CD4+ T-helper cells. This predisposes HIV patients to a variety of opportunistic infections and neoplastic disorders. also lead to defective hematopoiesis and a decrease in cell lineage. Haematological parameters including red blood cells, white blood cells, platelet and hemoglobin are widely used clinical indicators of health and disease.
Aim: The aim of this study was to assess haematological parameters in HIV patients attending Kabutare District hospital.
Methodology: This study was a cross-sectional study conducted to assess haematological parameters in HIV patients attending Kabutare District hospital. Venous blood sample were collected for complete blood count which was determined using sysmex 500i machine automation analyser.
Results: A total of 80 HIV infected patient participated. 7.5% of the study participants were proven to have white blood cells below the normal range as it was below 4.26.25% of patients were found below the normal range of red blood cells. Hemoglobin and hematocrit levels of 35% patients were found to below their normal ranges. 10% of patient were found to have low platelet and 23.5% were found to have low levels of lymphocytes. Association between CD4 counts and hemoglobin levels was significant with p value of 0.000 as it is less than confidence level of 0.05.
Conclusion: This study concluded that haematological parameters are affected by HIV infection and there is association between CD4 counts and hemoglobin concentration levels. I would recommend health practioners to also consider complete blood count as prognostic test of HIV as it is clinical health indicator and diseases.
Keywords: Haematological parameters, Human Immunodeficiency virus, CD4 counts, acquired immunodeficiency syndrome.
Evaluation of Antidepressant Like Activity of Extract of Boerhavia diffusa in Swiss Albino Mice
Authors: Yadav Shailja , Malaiya Saumya , Jain Harshita , Shrivastava Arpit 
Published: July 2024

Depression often known as depressive disorder is described by a persistent lack of enjoyment, enthusiasm in pursuits, or melancholy feelings. Depression is not the same as normal mood swings and feelings about day-to-day living. It could affect every aspect of life, including relationships with friends, family, and the community. It could be brought on by or exacerbated by problems at work or in the classroom. This study aims to evaluate antidepressant like activity of ethanolic extract of roots of Boerhavia diffusa (Nyctaginaceae). control and cure of this diseases, a vast variety of medications are used daily. The herbal drugs are biodegradable and are natural medications hence are becoming more and more popular. Using a Soxhlet equipment and a normal extraction procedure, the ethanolic extract was produced. The mice were administered several dosages of the extract (100, 200, and 400 mg/kg) in addition to the vehicle (normal saline) for the control group & ARS (Acute Restraint Stress) Group and fluoxetine as the conventional medication. The mice were subjected to ARS and were treated with ethanolic extract of Boerhavia diffusa at a dose of 100mg/kg, 200mg/kg and 400mg/kg respectively. After that they were subjected to animal models, the tail suspension test (TST), force suspension test (FST) to assess the antidepressant potential and open field test (OFT), to assess locomotor & antidepressant potential of administered drug The TST revealed prolonged immobility in the BDEE (Boerhavia diffusa ethanolic extract) treated animals. The crossing over of squares activity in the OFT rose, indicating a decline in depression levels. The mice's FST revealed a decrease in their ability to reach the plateau stage following immobility. According to the study, BDEE demonstrates strong antidepressant effect and offer a natural alternative to pharmaceutical treatment for depression disorders. In futuristic study, further investigation is required to identify certain active molecules and have a deeper comprehension of the underlying processes of action.
Keywords: Antidepressant activity, Boerhavia diffusa, Tail suspension test, Forced swim test, Open field test, Traditional medicine
Development of a Validated RP-HPLC/UV Method for the Quantitative Determination of Tyrosine Kinase RET Inhibitor: Selpercatinib in Capsule Formulation
Authors: Ramya Paka , Srinivas Medidi , Udaya Kumari Bula 
Published: July 2024

A validated RP-HPLC/UV method was developed to estimate the selpercatinib in capsules. The wavelength chosen for detection was at 248 nm. The RP-HPLC separation was carried out using a Hypersil ODS C18 column (250×4.6 mm, 5 μm) with a mobile phase consisting of 0.2% TFA (pH 6.5) and acetonitrile in a ratio of 70:30 v/v. The flow rate was set at 1 ml/min. The retention time for selpercatinib was determined to be 3.012 min. Linearity was detected within the concentration range of 2.5-15 μg/mL for selpercatinib. The approach has been confirmed to be linear, accurate, precise, robust, and has established limits of detection and quantitation. The established procedure was uncomplicated, cost-effective, and suitable for the routine analysis of selpercatinib in capsule dosage form.
Keywords: Selpercatinib, RP-HPLC and Validation.
333-OR: Hypoimmune Islet Cells Mediate Insulin Independence after Allogeneic Transplantation in a Fully Immunocompetent Nonhuman Primate without Immunosuppression
Authors: HU XIAOMENG , WHITE KATHY , YOUNG CHI , OLROYD ARI G. , KIEVIT PAUL , CONNOLLY ANDREW , DEUSE TOBIAS , SCHREPFER SONJA 
Published: July 2024

Treatment of type 1 diabetes mellitus (T1DM) via allogeneic donor transplant has limited success due to morbidities from immunosuppression (IS) and a gradual loss of engrafted pancreatic islet function. We report that allogeneic transplantation of engineered, primary, hypoimmune, pseudo-islets (HIP p-islets) engraft into a fully immunocompetent, diabetic non-human primate (NHP), provide stable endocrine function, and enable insulin independence without inducing any detectable immune response in the absence of IS. NHP cadaveric islet cells were engineered to disrupt function of MHC class I and II and overexpress CD47 thus rendering them hypoimmune (HIP). Diabetes was induced in the NHP with streptozotocin and daily insulin injections started to re-establish glucose control. After 78 days, NHP underwent transplantation of HIP p-islets by intramuscular injection resulting in insulin independence. As early as one week after the transplantation, the NHP’s serum c-peptide level had normalized and remained stable throughout the follow-up period of 6 months. The NHP showed tightly controlled blood glucose levels for 6 months, was completely insulin-independent, and continuously healthy. Up to 6 months after HIP p-islet transplantation, PBMCs and serum were obtained for immune analyses. HIP PI showed no T cell recognition, no graft-specific antibodies, and were protected from NK cell and macrophage killing. To prove that the monkey’s insulin-independence was fully dependent on the HIP p-islets graft and there was no regeneration of his endogenous islet cell population, we triggered the destruction of the HIP p-islet transplant using a CD47-targeting strategy resulting in loss of glycemic control and return to exogenous insulin dependence. These data demonstrate evidence for immune evasion of HIP p-islets, graft mediated insulin-independence of the diabetic NHP, and a potential safety strategy.

Disclosure
X. Hu: Employee; Sana Biotechnology. Stock/Shareholder; Sana Biotechnology. K. White: None. C. Young: Employee; Sana biotechnology. Stock/Shareholder; Sana biotechnology. A.G. Olroyd: Employee; Sana Biotechnology. Stock/Shareholder; Sana Biotechnology. P. Kievit: Consultant; Alnylam Pharmaceuticals, Inc., Embark Bio. Research Support; Sana Biotechnology, Novo Nordisk A/S. A. Connolly: None. T. Deuse: Stock/Shareholder; Sana Biotechnology, Shinobi Therapeutics. S. Schrepfer: Stock/Shareholder; Sana Biotechnology. Employee; Sana Biotechnology.
345-OR: Beyond Size Matters—The Impact of Pancreatic Volume and Pancreatic Fat on Type 2 Diabetes
Authors: YAMAZAKI HAJIME , TAUCHI SHIN-ICHI , DOHKE MITSURU , HANAWA NAGISA , KODAMA YOSHIHISA , KATANUMA AKIO , FUKUHARA SHUNICHI , PRYSTUPA KATSIARYNA , HUMMEL JULIA , WAGNER ROBERT , HENI MARTIN 
Published: July 2024

Introduction & Objective: Individuals with type 2 diabetes (T2D) are thought to have a smaller pancreas; however, whether this is cause or consequence of T2D is unclear. We investigated the association between pancreas volume and T2D risk and whether this association was modified by pancreatic fat.
Methods: Using magnetic resonance imaging from the UK Biobank, 25,389 individuals were classified into four groups based on the median values of pancreas volume (60 cm3) and pancreatic fat (8%). Odds ratios (ORs) for prevalent T2D were estimated using logistic regression. Additionally, we conducted a 6-year case-cohort study in an independent Japanese cohort using computed tomography during health examinations. Hazard ratios (HRs) for incident T2D were estimated using weighted-Cox regression in 658 randomly-selected individuals and 146 incident T2D cases among 2,168 individuals without diabetes. The regression models in both studies were adjusted for age, sex, body mass index, daily alcohol intake, current smoking, liver fat, and visceral fat.
Results: In the UK Biobank, individuals who had fat accumulation in a smaller pancreas exhibited the highest likelihood of T2D. Compared with large/low-fat pancreas, the adjusted ORs (95%CI) of T2D were 1.63 (1.36-1.97) in small/high-fat pancreas, 1.09 (0.89-1.33) in large/high-fat pancreas, and 1.08 (0.85-1.37) in small/low-fat pancreas. This finding was prospectively validated in the Japanese cohort with 6.27-year median follow-up. The adjusted HRs (95%CI) of incident T2D were 3.12 (1.40-6.96) in small/high-fat pancreas, 1.00 (0.59-1.69) in large/high-fat pancreas, and 0.74 (0.26-2.14) in small/low-fat pancreas.
Conclusion: Fat accumulation in an already smaller pancreas appears to be a key determinant of elevated T2D risk and might therefore be a novel target for preventive interventions.

Disclosure
H. Yamazaki: Other Relationship; AstraZeneca, Janssen Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma Corporation, Kowa Company, Ltd., Kyorin Pharmaceutical Co. Ltd, Takeda Pharmaceutical Company Limited, Takeda Pharmaceutical Company Limited, Magmitt Pharmaceutical Co. S. Tauchi: None. M. Dohke: None. N. Hanawa: None. Y. Kodama: None. A. Katanuma: None. S. Fukuhara: None. K. Prystupa: None. J. Hummel: None. R. Wagner: Speaker's Bureau; Sanofi. Advisory Panel; Lilly Diabetes. Speaker's Bureau; Boehringer-Ingelheim, Novo Nordisk. M. Heni: Research Support; Boehringer-Ingelheim. Advisory Panel; Amryt Pharma Plc. Speaker's Bureau; Amryt Pharma Plc. Advisory Panel; Boehringer-Ingelheim, Boehringer-Ingelheim. Speaker's Bureau; Lilly Diabetes, Novartis AG, Novo Nordisk, Sanofi.

Funding
Japan Society for the Promotion of Science KAKENHI grants (JP22K15685); Deutsche Forschungsgemeinschaft (DFG, German Research Foundation: 518749683)
346-OR: Hypothalamic Gliosis Is Associated with CVD Risk Factors in the Framingham Heart Study (FHS)
Authors: LO JUSTIN , MELHORN SUSAN J. , OLERICH KELSEY , HUANG ALYSSA , KEE SARAH , BEISER ALEXA , SESHADRI SUDHA , DECARLI CHARLES , SCHUR ELLEN 
Published: July 2024

Introduction: Hypothalamic gliosis is linked to obesity and insulin resistance in rodent models and humans. We tested associations between a radiologic measure of hypothalamic gliosis and clinically relevant cardiovascular disease (CVD) risk factors, as well as prevalent coronary heart disease (CHD).
Methods: Using brain MRI images from FHS participants (n=867), T2 signal intensities were extracted bilaterally from the region of interest in the mediobasal hypothalamus (MBH) and reference regions in amygdala (AMY) and putamen (PUT). T2 signal ratios were created in which greater values suggest gliosis. The primary measure compared MBH to AMY (MBH/AMY); a positive control ratio (MBH/PUT) also assessed MBH whereas a negative control (PUT/AMY) did not. Outcomes were BMI, HDL-C, LDL-C, triglycerides, and the presence of hypertension (HTN; n=225), diabetes mellitus (DM; n=66), or metabolic syndrome (MetS; n=254). Prevalent CHD (n=22) was adjudicated by FHS. Linear and logistic regression models included age, sex, smoking, treatment status (e.g., lipids), and BMI (for outcomes except BMI and MetS).
Results: Mean age was 54.9±8.8 y; 54.9% were female. Greater MBH/AMY ratios were associated with higher BMI (P&lt;0.001). MBH/AMY ratios were associated with higher triglycerides, presence of HTN, and lower HDL-C, and the latter two were independent of BMI (both P&lt;0.05). Results were consistent for the MBH/PUT ratios (all P&lt;0.05). Findings for DM were mixed and attenuated by adjusting for BMI. MetS was strongly associated with MBH/AMY and MBH/PUT ratios (P&lt;0.001). PUT/AMY ratios were unrelated to any outcome. No T2 signal ratio was associated with prevalent CHD (P&gt;0.05), and confidence intervals were wide.
Conclusion: Using a well-established study of CVD development, we found evidence linking hypothalamic gliosis to multiple CVD risk factors, independent of adiposity. Our results highlight the need to consider neurologic mechanisms in efforts to understand and improve cardiometabolic health.

Disclosure
J. Lo: None. S.J. Melhorn: None. K. Olerich: None. A. Huang: None. S. Kee: None. A. Beiser: None. S. Seshadri: None. C. DeCarli: None. E. Schur: Consultant; Amgen Inc.

Funding
National Institutes of Health (K24 HL144917; R01 DK089036; R01 DK117623; R01 DK098466; P30 DK035816)