bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of lifestyle or metformin interventions before IVF/ICSI treatment on infertile women with overweight/obese and insulin resistance: a factorial design randomised controlled pilot trial
Authors: Wang Xiaojuan , Cai Sufen , Tang Sha , Yang Lanlin , Tan Jing , Sun Xin , Gong Fei 
Published: September 2023

Abstract
Background
For infertile women with overweight/obesity and insulin resistance (IR), it is uncertain whether intervention before infertility treatment can improve live birth rate (LBR). We implemented a factorial-design study to explore the effectiveness of lifestyle and metformin interventions. This pilot study aimed to evaluate the feasibility of a definitive study.

Methods
We randomised 80 women without polycystic ovarian syndrome (PCOS) who planned to start their first or second IVF/ICSI treatment with a body mass index ≥ 25 kg/m2 and IR. Participants were randomised (1:1:1:1) into four groups: (A) lifestyle intervention, (B) metformin intervention, (C) lifestyle + metformin intervention, or (D) no intervention. All interventions were performed before IVF/ICSI treatment.

Results
During 10 months, 114 women were screened and eligible; 80 were randomised, and 72 received the assigned treatment. The recruitment rate was 70.18% (80/114, 95% CI 61.65%–78.70%). An average of 10 participants were randomised each month. None of the participants crossed over from one group to another. Approximately 93.15% (68/73) of the participants achieved good intervention compliance. Only 77.78% (56/72) of the recruited participants started infertility treatment after achieving the goal of the intervention. All randomised participants completed the follow-up. Mild adverse events after metformin administration were reported in 43.24% (16/37) of the cases, although no serious adverse events related to the interventions occurred. The LBR for groups A + C and B + D were 33.33% (12/36) and 33.33% (12/36) (RR = 1.00, 95%CI:0.52–1.92) (lifestyle intervention effect). The LBR for groups B + C and A + D were 43.24% (16/37) and 22.86% (8/35) (RR = 1.89, 95% CI:0.93–3.86) (metformin intervention effect). There was no evidence for an intervention interaction between lifestyle and metformin. We cannot yet confirm the effects of lifestyle, metformin, or their interaction owing to the insufficient sample size in this pilot study.

Conclusions
Instituting a 2 × 2 factorial design randomized controlled trial (RCT) is feasible, as the pilot study showed a high recruitment rate and compliance. There is no evidence that lifestyle or metformin improves live birth, and adequately powered clinical trials are required.

Trial registration
clinicaltrials.gov NCT03898037. Registered: April 1, 2019.
Personalized Biomarker-Based Umbrella Trial for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: KCSG HN 15-16 TRIUMPH Trial
Authors: Keam Bhumsuk , Hong Min Hee , Shin Seong Hoon , Heo Seong Gu , Kim Ji Eun , Ahn Hee Kyung , Lee Yun-Gyoo , Park Keon-Uk , Yun Tak , Lee Keun-Wook , Kim Sung-Bae , Lee Sang-Cheol , Kim Min Kyoung , Cho Sang Hee , Oh So Yeon , Park Sang-Gon , Hwang Shinwon , Nam Byung-Ho , Kim Sangwoo , Kim Hye Ryun , Yun Hwan Jung ,   on behalf of KCSG TRIUMPH Investigators
Published: September 2023

PURPOSE
A precise oncologic approach for head and neck squamous cell carcinoma (HNSCC) is necessary. We performed a genomic profile-based umbrella trial for the patients with platinum-refractory recurrent and/or metastatic HNSCC.

METHODS
In this multicenter, open-label, single-arm phase II trial, we performed targeted next-generation sequencing (NGS). Patients were assigned to each treatment arm on the basis of their matching genomic profiles: arm 1, alpelisib, a PIK3CA inhibitor; arm 2, poziotinib, an epidermal growth factor receptor/HER2 inhibitor; arm 3, nintedanib, an fibroblast growth factor receptor inhibitor; and arm 4, abemaciclib, a CDK4/6 inhibitor. If there was no matching target, patients were allocated to arm 5, duvalumab ± tremelimumab, anti–PD-L1/cytotoxic T-cell lymphocyte-4 inhibitor. When progressive disease (PD) occurred in arms 1-4, cross over to arm 5 was allowed. The primary end point was disease control rate (DCR) in arm 1 and overall response rate (ORR) in arms 2-5 by investigator assessment.

RESULTS
Between October 2017 and August 2020, 203 patients were enrolled, including crossover. In arm 1, the ORR was 21.2% and DCR was 65.6%. The ORR was 0% for arm 2, 42.9% for arm 3, 0% for arm 4, and 15.6% for arm 5. In the case of PD with durvalumab, tremelimumab was added, and the ORR for durvalumab + tremelimumab was 2.2%. The median progression-free survival was 3.4, 3.2, 5.6, 1.6, and 1.7 months for each arm, respectively. The median overall survival was 12.4, 6.1, 11.1, 9.1, and 12.7 months, respectively. Overall, the toxicity profiles were manageable, and there were no treatment-related deaths.

CONCLUSION
To our knowledge, this study is the first biomarker-driven umbrella trial for platinum-refractory HNSCC using matched molecular targeted agents. We found that NGS-based genomic phenotyping was methodologically feasible and applicable.
Fatigue Resistance Is Altered during the High-Hormone Phase of Eumenorrheic Females but not Oral Contraceptive Users
Authors: Lee Serene J.L. , Sim Marc , Van Rens Fleur E.C.A. , Peiffer Jeremiah J. 
Published: September 2023

ABSTRACT

Purpose
To examine the effect of ovarian hormones and their synthetic equivalents on substrate utilisation and fatigue resistance during a race-specific cycling protocol.

Methods
17 well-trained female cyclists (9 eumenorrheic females, 8 oral contraceptive users), completed two experimental trials, in a randomised order, in their low (follicular/sugar pill) and high-hormone (luteal/active pill) phases. Each 91-min trial consisted of a 45-min moderate-intensity component (SMC) followed by 6-min of high-intensity (HIT) and then a fatigue resistance test (FRT): 6x1-min all-out efforts with 1-min active recovery. Meals, comprising carbohydrate (CHO) intake of 8 g.kg-1 body mass, were standardised 24-h pre-trial. An electrolyte-only solution was provided ad-libitum during each trial.

Results
In eumenorrheic females, a large reduction in average power during FRT was observed in the luteal phase (277 ± 31 vs. 287 ± 33 W; P = 0.032). Greater CHOox (~ 4 %, P = 0.020) during SMC and ventilatory inefficiencies during SMC and HIT (~ 7 %, P < 0.001) were also observed in the luteal phase. In OC users, despite some phasal changes in cardiorespiratory and metabolic data in SMC (~6% higher blood glucose and ~ 2% higher minute ventilation in active pill phase), none of the performance parameters in the FRT were different.

Conclusions
Fatigue resistance was compromised only in high-hormone phase of the menstrual cycle, with eumenorrheic females likely susceptible due to increased CHO utilisation during SMC. Hormone-induced ventilatory inefficiencies may also have increased metabolic demand. These findings emphasise the need to maintain CHO availability for power production, particularly in high-hormone phases.
AI in medical imaging grand challenges: translation from competition to research benefit and patient care
Authors: Armato Samuel G , Drukker Karen , Hadjiiski Lubomir 
Published: September 2023

Abstract
Artificial intelligence (AI), in one form or another, has been a part of medical imaging for decades. The recent evolution of AI into approaches such as deep learning has dramatically accelerated the application of AI across a wide range of radiologic settings. Despite the promises of AI, developers and users of AI technology must be fully aware of its potential biases and pitfalls, and this knowledge must be incorporated throughout the AI system development pipeline that involves training, validation, and testing. Grand challenges offer an opportunity to advance the development of AI methods for targeted applications and provide a mechanism for both directing and facilitating the development of AI systems. In the process, a grand challenge centralizes (with the challenge organizers) the burden of providing a valid benchmark test set to assess performance and generalizability of participants’ models and the collection and curation of image metadata, clinical/demographic information, and the required reference standard. The most relevant grand challenges are those designed to maximize the open-science nature of the competition, with code and trained models deposited for future public access. The ultimate goal of AI grand challenges is to foster the translation of AI systems from competition to research benefit and patient care. Rather than reference the many medical imaging grand challenges that have been organized by groups such as MICCAI, RSNA, AAPM, and grand-challenge.org, this review assesses the role of grand challenges in promoting AI technologies for research advancement and for eventual clinical implementation, including their promises and limitations.
Artificial intelligence in mental healthcare: an overview and future perspectives
Authors: Jin Kevin W , Li Qiwei , Xie Yang , Xiao Guanghua 
Published: September 2023

Abstract
Artificial intelligence is disrupting the field of mental healthcare through applications in computational psychiatry, which leverages quantitative techniques to inform our understanding, detection, and treatment of mental illnesses. This paper provides an overview of artificial intelligence technologies in modern mental healthcare and surveys recent advances made by researchers, focusing on the nascent field of digital psychiatry. We also consider the ethical implications of artificial intelligence playing a greater role in mental healthcare.
Reduction of hydrocarbon pollutants by hyacinth plants (Eichhornia crassipes)
Authors: Nedi Syahril , Effendi Irwan , Tanjung Afrizal , Elizal Elizal 
Published: September 2023

Background: The application of phytoremediation by utilizing plants has been used to control oil pollution in waters. One of the plants that can act as a phytoremediator is the hyacinth because this plant can reduce various pollutants including petroleum hydrocarbons. This study aims to study the reduction ability of petroleum hydrocarbons at different concentrations including improving water quality. Methods: This research used an experimental method implementing a Completely Randomized Design (CRD) with one factor, namely TPH concentration with five treatment levels and three replications. The treatments were as follows E1 (10 mg/L), E2 (30 mg/L), E3 (50 mg/L), E4 (70 mg/L), and E5 (90 mg/L), and E0 (control) was carried out only at the highest concentration (90 mg/L), aiming to see whether there was a TPH reduction process without plants. Maintenance of water hyacinth was carried out in media with salinity (3 ppt). Observations were made for 14 days, with measurements of TPH and leaf chlorophyll content observed at D-1, D-7 and D-14. While water quality parameters such as temperature, pH and dissolved oxygen were observed every 2 days Results: The results showed that the hyacinth plant was able to reduce hydrocarbon in terms of total petroleum hydrocarbon (TPH) by 79% while it was only between 17–27% naturally without the hyacinth. The reduction of TPH in the water was in line with the decrease of chlorophyll in the leaves of hyacinths, and it was followed by the increase of dissolved oxygen in the water media. Conclusions: In conclusion, hyacinths can reduce petroleum hydrocarbons and they can improve the water quality as well. Futhermore, water hyacinth which are commonly found in freshwater can be used as phytoremediatiors in coastal area; its application in coastal areas requires futher study
Comparative evaluation of periapical healing in response to calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph
Authors: Umre Utkarsh , Sedani Shweta , Nikhade Pradnya , Bansod Akansha Vilas , Mishra Abeer 
Published: September 2023

Background: Success of root canal treatment depends upon 3-D seal obtained after obturation without any presence of post-operative symptoms. The focus of this investigation is on ability of a sealer to form 3D seal and to reduce periapical lesion. The study aims to evaluate periapical healing of teeth treated with calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph. The objectives of this study will be to evaluate periapical healing ability of root canal treated teeth with Sealapex, Nanoseal-S and Bio-ceramic sealers over the time period of 3, 6 and 9 months; and to compare the periapical healing ability of a root canal treated tooth. Methods: A total of 60 subjects having periapical radiolucencies will be divided into 3 groups of 20 subjects each; Group I- Calcium hydroxide based, Group II- Polydimethyl siloxane based and Group III- Calcium Silicate based sealers. Root canal procedure will be done. Patients will be recalled after 3, 6, 9 months for the evaluation of periapical healing and PAI score check-up using intraoral periapical radiograph. Expected results: It is expected that among the material used in the study Bio-Ceramic and Nanoseal-S sealer may give better results as compared to Sealapex used in routine practice due to its ability of anti-microbial properties, optimal biocompatibility and excellent sealing ability. Conclusion: Comparison amongst the three sealers would provide us with the information about the best material which offers better periapical healing to get the best outcome of the root canal treatment by clinician.
Predicting multi-vascular diseases in patients with coronary artery disease
Authors: Adiarto Suko , Nurachman Luthfian Aby , Dewangga Raditya , Indriani Suci , Taofan Taofan , Alkatiri Amir Aziz , Firman Doni , Santoso Anwar 
Published: September 2023

Background: Because of its systemic nature, the occurrence of atherosclerosis in the coronary arteries can also indicate a risk for other vascular diseases. However, screening program targeted for all patients with coronary artery disease (CAD) is highly ineffective and no studies have assessed the risk factors for developing multi-vascular diseases in general. This study constructed a predictive model and scoring system to enable targeted screening for multi-vascular diseases in CAD patients. Methods: This cross-sectional study includes patients with CAD, as diagnosed during coronary angiography or percutaneous coronary intervention from March 2021 to December 2021. Coronary artery stenosis (CAS) and abdominal aortic aneurysm (AAA) were diagnosed using Doppler ultrasound while peripheral artery disease (PAD) was diagnosed based on ABI score. Multivariate logistic regression was conducted to construct the predictive model and risk scores. Validation was conducted using ROC analysis and Hosmer-Lemeshow test. Results: Multivariate analysis showed that ages of >60 years (OR [95% CI] = 1.579 [1.153-2.164]), diabetes mellitus (OR = 1.412 [1.036-1.924]), cerebrovascular disease (OR = 3.656 [2.326-5.747]), and CAD3VD (OR = 1.960 [1.250-3.073]) increased the odds for multi-vascular disease. The model demonstrated good predictive capability (AUC = 0.659) and was well-calibrated (Hosmer-Lemeshow p = 0.379). Targeted screening for high-risk patients reduced the number needed to screen (NNS) from 6 in the general population to 3 and has a high specificity of 96.5% Conclusions: Targeted screening using clinical risk scores was able to decrease NNS with good predictive capability and high specificity
Faculty development for strengthening online teaching capability: a mixed-methods study of what staff want, evaluated with Kirkpatrick’s model of teaching effectiveness
Authors: Singleton Rachelle , Ruiz Cosignani Daniela , Kam Monica , Clune Megan , Charlton Amanda , Jowsey Tanisha 
Published: September 2023

Background: Globally, tertiary teachers are increasingly being pushed and pulled into online teaching. While most developments in online education have focused on the student perspective, few studies have reported faculty development (FD) initiatives for increasing online teaching capability and confidence from a staff perspective. Method: We designed and evaluated FD workshops, using five datasets, and the use of H5P software for interactive online teaching. We used educational theory to design our FD (Mayer multimedia principles, active learning) and evaluated our FD initiatives using the Best Evidence Medical Education (BEME) 2006 modified Kirkpatrick levels. Results: Teaching staff reported that Communities of Practice were important for their learning and emotional support. Uptake and deployment of FD skills depended on the interactivity of FD sessions, their timeliness, and sufficient time allocated to attend and implement. Staff who applied FD learning to their online teaching created interactive learning resources. This content was associated with an increase in student grades, and the roll-out of an institutional site-wide H5P license. Conclusion: This paper demonstrates an effective strategy for upskilling and upscaling faculty development. The use of H5P as a teaching tool enhances student learning. For successful FD, we make four recommendations. These are: provide just-in-time learning and allocate time for FD and staff to create online teaching material; foster supportive communities; offer personalized support; and design hands on active learning.
Association of MG53 with presence of type 2 diabetes mellitus, glycemic control, and diabetic complications
Authors: Andaç Burak , Özgün Eray , Bülbül Buket Yılmaz , Çolak Serpil Yanık , Okur Mine , Yekdeş Ali Cem , Öcal Eftal , Tapan Mehmet Emin , Çelik Mehmet 
Published: September 2023

Objectives
Mitsugumin 53 (MG53) is a myokine that acts as a membrane repair protein in tissues. Data on the effect of MG53 on insulin signaling and type 2 diabetes mellitus (T2 DM) are still unknown; most are from preclinical studies. Nevertheless, some researchers have argued that it may be a new pathogenic factor, and therapies targeting MG53 may be a new avenue for T2 DM. Our study aims to evaluate the relationship of circulating MG53 levels with the presence of diabetes, diabetic complications, and glycemic control.

Methods
We conducted a case-control study with 107 patients with T2 DM and 105 subjects without insulin resistance-related disease. Concurrent blood samples were used for serum MG53 levels and other biochemical laboratory data. MG53 concentration was measured using Human-MG53, an enzyme-linked immunosorbent assay kit (Cat# CSB-EL024511HU).

Results
We found no difference in MG53 levels between the diabetic and control groups (p = 0.914). Furthermore, when the subjects were divided into tertiles according to their MG53 levels, we did not find any difference between the groups in terms of the presence of diabetes (p = 0.981). Additionally, no correlation was observed between weight, BMI, waist circumference, systolic and diastolic blood pressure, fasting blood glucose, HbA1c, albumin excretion in the urine, e-GFR levels, and MG53. Finally, MG53 levels were similar between the groups with and without microvascular and macrovascular complications of diabetes.

Conclusion
Our research finding provides insightful clinical evidence of lack of association between the levels of MG53 and T2 DM or glycemic control, at least in the studied population of Turkeys ethnicity. However, further clinical studies are warranted to establish solid evidence of the link between MG53, insulin resistance and glycemic control in a wider population elsewhere in the world.
Myalgic Encephalomyelitis—Chronic Fatigue Syndrome Common Data Element item content analysis
Authors: Slavin Mary D. , Bailey Hannah M. , Hickey Emily J. , Vasudevan Ananya , Ledingham Aileen , Tannenbaum Linda , Bateman Lucinda , Kaufman David L. , Peterson Daniel L. , Ruhoy Ilene S. , Systrom David M. , Felsenstein Donna , Kazis Lewis E. 
Published: September 2023

Introduction
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a multisystem chronic disease estimated to affect 836,000–2.5 million individuals in the United States. Persons with ME/CFS have a substantial reduction in their ability to engage in pre-illness levels of activity. Multiple symptoms include profound fatigue, post-exertional malaise, unrefreshing sleep, cognitive impairment, orthostatic intolerance, pain, and other symptoms persisting for more than 6 months. Diagnosis is challenging due to fluctuating and complex symptoms. ME/CFS Common Data Elements (CDEs) were identified in the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element Repository. This study reviewed ME/CFS CDEs item content.

Methods
Inclusion criteria for CDEs (measures recommended for ME/CFS) analysis: 1) assesses symptoms; 2) developed for adults; 3) appropriate for patient reported outcome measure (PROM); 4) does not use visual or pictographic responses. Team members independently reviewed CDEs item content using the World Health Organization International Classification of Functioning, Disability and Health (ICF) framework to link meaningful concepts.

Results
119 ME/CFS CDEs (measures) were reviewed and 38 met inclusion criteria, yielding 944 items linked to 1503 ICF meaningful concepts. Most concepts linked to ICF Body Functions component (b-codes; n = 1107, 73.65%) as follows: Fatiguability (n = 220, 14.64%), Energy Level (n = 166, 11.04%), Sleep Functions (n = 137, 9.12%), Emotional Functions (n = 131, 8.72%) and Pain (n = 120, 7.98%). Activities and Participation concepts (d codes) accounted for a smaller percentage of codes (n = 385, 25.62%). Most d codes were linked to the Mobility category (n = 69, 4.59%) and few items linked to Environmental Factors (e codes; n = 11, 0.73%).

Discussion
Relatively few items assess the impact of ME/CFS symptoms on Activities and Participation. Findings support development of ME/CFS-specific PROMs, including items that assess activity limitations and participation restrictions. Development of psychometrically-sound, symptom-based item banks administered as computerized adaptive tests can provide robust assessments to assist primary care providers in the diagnosis and care of patients with ME/CFS.
The sweet spot study—Developing e-liquid product standards for nicotine form and concentration to improve public health: Protocol for a randomized, double-blinded, crossover study
Authors: Cho Yoo Jin , Brinkman Marielle C. , Hinton Alice , Nshimiyimana Jean D. , Mehta Toral , Adeniji Ayomipo , Norton Kaila , El Hellani Ahmad , Wagener Theodore L. 
Published: September 2023

Objectives
E-cigarettes pose significant risks to youth, but smokers may benefit from switching to e-cigarettes by reducing their exposure to toxicants, which creates a challenge for the Food and Drug Administration (FDA) in regulating e-cigarettes to protect population health. This study aims to develop e-liquid product standards for nicotine form and concentration that reduce the appeal of e-cigarettes to young people while keeping e-cigarettes available as a safer alternative for smokers.

Design and participants
A single-visit, double-blinded, randomized crossover design will be used to examine the effects of e-liquids with varying fractions of free-base nicotine (5%, 25%, 45%, 65%, 85%) among a sample of 66 young adult EC users and 66 older adult smokers, across ecologically valid total nicotine concentrations (20 mg or 50 mg/mL).

Interventions and outcomes
A 2-puff session will be conducted to test each of the 10 e-liquids in randomly assigned sequences, followed by a 10-minute washout period and participant ratings on appeal and sensory attributes such as throat hit and harshness, as well as behavioral intentions for continued use. Generalized linear mixed models will be used to determine a free-base nicotine level that has limited or no appeal to young adult e-cigarette users while remaining acceptable to smokers.

Conclusions
This study will provide the FDA with scientific evidence regarding the effect of product standards that mandate a minimum threshold for the fraction of free-base nicotine.

Trial registration
The study is registered on clinicaltrials.gov under the identifier NCT05864586.