bluuebunny/crossref_metadata_2025_split huggingface dataset:
Study protocol: Effects of active versus passive recharge burst spinal cord stimulation on pain experience in persistent spinal pain syndrome type 2: a multicentre randomized trial (BURST-RAP study)
Authors: Mons Martijn R. , Edelbroek Caro , Zuidema Xander , Bürger Katja , Elzinga Lars , de Vries Jessica , van Kuijk Sander , Joosten Elbert A. , Kallewaard Jan-Willem 
Published: September 2022

Abstract
Background
Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Within burst stimulation, a recharge pattern is used to prevent buildup of charge in stimulated tissues. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It has been suggested that differences exist between active and passive recharge paradigms related to both efficacy of pain relief and their underlying mechanism of action. Active recharge has been shown to activate both the medial spinal pathway, engaging cortical sensorimotor areas involved in location and intensity of pain, and lateral pathway, reaching brain areas involved with cognitive-emotional aspects of pain. Passive recharge has been suggested to act via modulation of thalamic neurons, which fire in a similar electrical pattern, and thereby modulate activity in various cortical areas including those related to motivational and emotional aspects of pain. The objective of this randomized clinical trial is to assess and compare the effect of active versus passive recharge Burst SCS on a wide spectrum of pain in PSPS Type 2 patients.

Methods
This multicentre randomized clinical trial will take place in 6 Dutch hospitals. PSPS Type 2 patients (n=94) will be randomized into a group receiving either active or passive recharge burst. Following a successful trial period, patients are permanently implanted. Patients complete the Pain Catastrophizing Scale (PCS) (primary outcome at 6 months), Numeric Pain Rating Scale (NRS), Patient Vigilance and Awareness Questionnaire (PVAQ), Hospital Anxiety and Depression Scale (HADS), Quality of Life (EQ-5D), Oswestery Disability Index (ODI), Patient Global Impression of Change (PGIC) and painDETECT questionnaires (secondary outcomes) at baseline, after trial, 1, 3, 6 and 12 months following implantation.

Discussion
The BURST-RAP trial protocol will shed light on possible clinical differences and effectivity of pain relief, including emotional-motivational aspects between active and passive burst SCS in PSPS Type 2 patients.

Trial registration
ClinicalTrials.gov registration: NCT05421273. Registered on 16 June 2022. Netherlands Trial Register NL9194. Registered on 23 January 2021.
Pediatric Tuina for functional constipation in children: study protocol for a randomized controlled trail
Authors: Zhang Xinghe , Hu Luan , Li Li , Wang Yuanwang , Zhang Can , Su Jinyan , Di Hua , Gao Qing , Tai Xiantao , Guo Taipin 
Published: September 2022

Abstract
Background
Functional constipation (FC) is a common functional gastrointestinal disorder, which brings many negative impacts to the children’s daily life. Pediatric Tuina has been proved to be a potential therapy for FC. However, the evidence for its effectiveness and safety is insufficient due to the lack of high-quality study. This study aims to evaluate the efficacy and safety of pediatric Tuina for children with FC.

Methods/design
This study is a randomized, controlled, multicentre, clinical trial. We will include 176 children with FC from five hospitals. The participants will be randomly allocated into two groups: the pediatric Tuina group and the Medilac-Vita group. This study will include a 1-week actual treatment period and a 2-week follow-up period. Primary outcomes are weekly spontaneous bowel movements and weekly complete spontaneous bowel movements. The secondary outcomes are effective rate, stool form, distress sensation, and glycerine enema rate. The assessment will be performed each week. Adverse event will be monitored in the treatment period and follow-up period.

Discussion
This study is designed to evaluate the efficacy and safety of pediatric Tuina for children with FC, and we hypothesize that pediatric Tuina is more effective than probiotics. It will provide reliable evidence and support for the treatment of FC by pediatric Tuina.

Trial registration
This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2100046485).
The effects of aerobic exercise on body composition in overweight and obese patients with gout: a randomized, open-labeled, controlled trial
Authors: Jia Ertao , Zhu Haiqiong , Geng Hongling , Liu Ruilin , Wo Xueqian , Zeng Yaochi , Ma Wukai , Yao Xueming , Zhan Zhiying , Zhang Jianyong 
Published: September 2022

Abstract
Background
Overweight and obesity are typical risk factors for the increased prevalence and incidence of gout. The existing guidelines unequivocally indicated that exercise is highly advantageous for patients with gout. Nevertheless, there is still a lack of specific guidance and clinical evidence. The effects of exercise on improving gout, and the optimal frequency, timing, and types of exercise have not been fully clarified. The present trial aims to determine the effects of a specific aerobic exercise program on body composition in overweight and obese patients with gout.

Methods
In this randomized, open-labeled, controlled trial, a total of 60 overweight and obese patients with gout [body mass index (BMI) ≥ 24 kg/m2; age,18–55 years old] are equally randomized (1:1) into two groups (n = 30): moderate-intensity aerobic exercise group (MIAEG), heart rate reserve (HRR) = [(HRmax-HRrest) × 60% intensity] + HRrest, and control group (CG). The moderate-intensity aerobic exercise training program will be conducted for 30–40 min/session and 3 days/week for 12 weeks. Participants in the CG will be asked to avoid making changes in their exercise habits. There will be no limitation in the type of exercise. The primary outcome is the number of patients whose body fat is reduced after 12 weeks. The secondary outcomes include the changes in BMI, waist-to-hip ratio (WHR), insulin resistance index (IRI), serum uric acid (sUA), serum creatinine (SCr), estimated glomerular filtration rate (eGFR), triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), hepatic steatosis, and adverse effects after 12 weeks. One-way analysis of variance (ANOVA) will be used to compare the mean values of normally distributed variables between MIAEG and GC.

Discussion
The effect and optimal frequency of exercise for improving the status of overweight and obese patients with gout have not yet been determined. We design a 12-week randomized controlled trial and evaluate the effects of individualized aerobic exercise program on patients with gout. The results may assist such patients with a personalized scientific exercise program based on the disease status and motor abilities, so that patients are prone to exercise under the condition of low risk and achieve the greatest benefits.

Trial registration
ChiCTR2200062153. Registered on July 25, 2022, with ChiCTR. http://www.chictr.org.cn/
Potential benefits of a virtual, home-based combined exercise and mindfulness training program for HSC transplant survivors: a single-arm pilot study
Authors: Ma David D. F. , Fennessy Kate , Kliman David 
Published: September 2022

Abstract
Purpose
Impaired quality of life (QOL) including reduced physical fitness is a recognized late effect of hemopoietic cell transplantation (HCT). Guided exercise and mindfulness-based stress management (MBSM) programs have shown promise, mainly in the inpatient setting. We aimed to examine the feasibility of a virtual, home-based, combined exercise and MBSM program.

Methods
Patients attending post-HCT clinic were invited to participate in this single-arm pre-post study. Eligibility criteria included age 18–75 years, > 6 months post allogeneic HCT. Consented participants attended an in-person session, followed by weekly exercise and MBSM training for 6 weeks via videoconferencing. Assessments were performed pre-training, and at 3-, 6- and 12-months and compared using a linear mixed effects model.

Results
21 of 24 patients consenting to the study completed the program (median age 56 years [IQR 46–62], median time post-HCT 37 months [IQR 26–46]). Six-minute walk test scores were significantly higher at 3 (mean difference 79.6, 95%CI 28–131, ES 0.55) and 12 months (mean difference 48.4, 95%CI 13–84, ES 0.33) compared to baseline. Sit-to-stand test was significantly higher at 3 (mean difference 4.4, 95%CI 1.4–7.4, ES 0.68) and 12 months (mean difference 3.9, 95%CI 0.24–7.6, ES 0.61). Dominant hand grip was significantly stronger at 3 (mean difference 0.16, 95%CI 0.04–0.28, ES 0.45), and 12 months (mean difference 0.21, 95%CI 0.08–0.24, ES 0.62). Significantly higher FACT-BMT total (mean difference 6.9, 95%CI 1.5–12.4, ES 0.49) and FACT-G scores (mean difference 5.2, 95%CI 1.4–9.1, ES 0.48) were found at 3 months. Over 80% of participants rated the virtual combined modal program highly and no adverse events were reported.

Conclusion
A 6-week virtual, home-based exercise and MBSM program was an acceptable, and potentially effective intervention for sustained improvement of some physical capacity and QOL outcomes in HCT survivors. Virtual-based healthcare service is highly relevant particularly during pandemics. To our knowledge, this study has the longest follow-up observation period for Internet based combined modality training program reported to date and warrants additional investigation.
Trial Registration Research protocol approved by St Vincent’s Hospital Ethics Committee (HREC 12/SVH/175), approved 27/09/2012, trial commenced 24/05/13 and the first participant 07/06/13. Retrospectively registered with ANZCTR (ACTRN12613001054707) 23/09/2013.
Hungarian male water polo players’ body composition can predict specific playing positions and highlight different nutritional needs for optimal sports performance
Authors: Fritz Péter , Fritz Réka , Mayer Lívia , Németh Boglárka , Ressinka Judit , Ács Pongrác , Oláh Csilla 
Published: September 2022

Abstract
Background
Water polo is unique among aquatic—and generally other—sports as it includes cyclic elements typical in swimming and acyclic elements occurring mainly in ball games. Moreover, water polo demands high level of technical and tactical skills. Players need an optimal nutritional and physical condition to achieve high athletic performance, which is to a great extend influenced by nutritional habits. We aim to highlight possible shortfalls in players’ nutritional intake in relation to positions played within the team.

Methods
In the present study, we determined the anthropometric and body composition characteristics, dietary habits and laboratory parameters of elite adult male water polo players (n = 19) before the start of the championship and at the end of the regular season, which meant a 4-month intervention period. Analyses of body composition characteristics and nutritional habits were performed using bioimpedance analyzer InBody 770 and a 3-day nutrition diary, respectively. Paired-sample t-test were used to determine the differences between the variables measured before and after the championship. Correlations between the anthropometric and body composition characteristics and different serum parameters were analyzed using linear correlation calculation. K-mean cluster analysis was performed using the anthropometric and body composition characteristics of the athletes.

Results
Based on anthropometric and body composition characteristics, players can be divided into two significantly different clusters that shows an association with specific playing positions. Cluster I included goalkeepers and wing players, while defenders, centers, and shooters belonged to Cluster II. We observed significant differences in the physical composition and slight but not significant differences in nutritional habits of the clusters. Cluster I players were 5 cm shorter on average, while their mean body weight, skeletal muscle mass and body fat mass data were lower by 19 kg, 7 kg, and 7 kg, respectively. We studied the correlation between initial anthropometric and body composition parameters and the changes in laboratory parameters before and after the regular season. As a result, we detected numerous significant differences between the two clusters, such as the changes in glucose and magnesium levels, which showed a strong correlation with several body composition parameters in cluster II, but did not in cluster I.

Conclusions
Cluster differences between anthropometric and body compositional characteristics, and the changes in laboratory parameters can help to develop position-specific training and nutritional recommendations in the future. Therefore, the results may be applicable in sport sciences for elite athletes and sports coaches.
Dried blood spot is the feasible matrix for detection of some but not all hepatitis B virus markers of infection
Authors: Kikuchi Minami , Lindstrom Patrick , Tejada-Strop Alexandra , Mixson-Hayden Tonya , Kamili Saleem , Sawabe Motoji 
Published: September 2022

Abstract
Objective
Use of dried blood spots (DBS) for detection of hepatitis B virus (HBV) markers of infection has the potential to facilitate diagnosis of HBV infection especially in resource-limited countries. The aim of this study was to evaluate the feasibility of DBS for detection of various markers of HBV infections.

Results
Fifty-four DBS samples were engineered from well-characterized plasma samples. All DBS samples were tested for HBsAg, total anti-HBc and HBV DNA, 20 of 54 samples were also tested for HBeAg using commercially available assays. HBsAg was detected in 24 of 25 (96%), HBV DNA in 22 of 25 (88%), total anti-HBc in all 9 (100%), and HBeAg in all 7 (100%) DBS samples. The average difference in HBV DNA levels between DBS eluates and corresponding plasma samples was 2.7 log10 IU/mL. Fifteen DBS eluates positive for HBV DNA were sequenced and all of them belonged to HBV genotype A. Thirteen samples which were negative for all HBV markers showed HBeAg false positivity. Therefore, DBS is a reliable sample matrix for detection of HBsAg, total anti-HBc and HBV DNA, but not HBeAg. Further feasibility studies of DBS for diagnostic purposes and epidemiologic studies are warranted.
Expression of osteopontin-5 splice variant in the mouse primary and metastatic breast cancer cells
Authors: Kamalabadi-Farahani Mohammad , Atashi Amir , Jabbarpour Zahra , Aghayan Seyed Sajjad 
Published: September 2022

Abstract
Objective
Osteopontin (OPN) is a well-known glycoprotein involved in numerous pathobiological processes, including cancer. Despite having five splice variants for osteopontin in mice, the main focus of most studies has been on total OPN (tOPN). There are some studies on other splice variants, but the expression of osteopontin-5 (OPN5) has not been addressed in mouse cancer cells. Therefore, this study sought to evaluate OPN5 expression in mouse breast cancer cells.

Results
The expression of OPN5 in primary and metastatic breast cancer cells of mice was confirmed in our study. These findings provided important insights regarding the OPN alternative splicing in mice for the first time. It is concluded that, like other OPN-SVs, OPN5 probably plays an essential role in tumor progression, which requires further investigation in different tumor models.
Efficacy and safety of dutasteride with tadalafil add-on therapy in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia
Authors: Gotoh Daisuke , Torimoto Kazumasa , Morizawa Yosuke , Hori Shunta , Nakai Yasushi , Miyake Makito , Fujimoto Kiyohide 
Published: September 2022

Abstract
Objective
To evaluate the efficacy and safety of add-on therapy with the phosphodiesterase type 5 inhibitor tadalafil in Japanese men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) treated with dutasteride.

Results
Twenty-four patients were enrolled. The participants had a median age of 71.0 (64.8–73.0) years and a median prostate volume of 37.3 (29.7–41.8) mL as measured using transabdominal sonography. The efficacy indicators, such as International Prostate Symptom Score (IPSS), quality of life (QOL) score, night-time urinary frequency, and night-time maximum voided volume, improved significantly at 4 weeks, and the effects lasted until 24 weeks (IPSS: 9.5 vs. 17.0, QOL: 2.0 vs. 4.0, nocturia: 2.0 vs. 2.0, night-time maximum voided volume: 290.0 vs. 240.0 mL). Overactive bladder symptom score (OABSS) and sexual health inventory for men (SHIM) significantly improved at 12 weeks, and the effects lasted until 24 weeks (OABSS: 3.0 vs. 5.0, SHIM: 11.0 vs. 7.5). However, maximum urine flow and residual urine volume showed no improvement at any point. Adverse events occurred in two cases. Taken together, add-on therapy with tadalafil was effective for patients with LUTS/BPH resistant to dutasteride monotherapy. In addition, this therapy was not associated with severe adverse events.
Interventions and methods to prepare, educate or familiarise children and young people for radiological procedures: a scoping review
Authors: Bray Lucy , Booth Lisa , Gray Victoria , Maden Michelle , Thompson Jill , Saron Holly 
Published: September 2022

AbstractChildren attending hospital for radiological procedures can experience uncertainty, anxiety and distress; this can result in sub-optimal experiences for children, poor scan quality and the need for radiological procedures to be rescheduled or sedation to be used. The preparation and education of children before clinical procedures has been shown to have a positive influence on procedural outcomes. This scoping review aimed to locate and examine the evidence relating to non-invasive interventions and methods to prepare, educate and familiarise children for radiological procedures within a healthcare setting. A comprehensive search strategy identified 36 articles. A narrative synthesis approach was adopted to make sense of the key findings. Studies investigated a range of radiological procedures (MRI, plain radiographs, CT, fluoroscopy and Micturating cystourethrogram) using a wide range of interventions (smartphone applications, storybooks, videos, mock scanners) which varied by method, mode of delivery and target audience. The outcomes used to evaluate the value and impact of the interventions are wide, varied and inconsistently applied making it difficult to judge which interventions offer the optimal impact on scan quality, scan completion and children’s experiences. This review highlights that there is a need to further understand which specific elements of the non-invasive interventions ‘work best’ for children. There is a need for consistency on the outcomes measured and for these measures to include child-centred outcomes alongside scan quality and length of radiological procedure.
Multiparametric MRI with MR elastography findings in patients with sinusoidal obstruction syndrome after oxaliplatin-based chemotherapy
Authors: Poker Ahmet , Karcaaltıncaba Musturay , Ozmen Mustafa N. , Karaosmanoğlu Ali D. , Erdemir Ahmet G. , Ocal Osman , Akata Deniz , Idilman Ilkay S. 
Published: September 2022

Abstract
Objective
To evaluate the magnetic resonance elastography (MRE)-derived liver stiffness measurement (LSM), T1 and T2 relaxation times, and hepatobiliary phase images in patients, who developed sinusoidal obstruction syndrome (SOS) after oxaliplatin-based chemotherapy.

Methods
Thirty-four patients (M/F:22/12) who underwent liver MRI-MRE and received oxaliplatin for colorectal, gastric, and pancreas cancer were included in the study. SOS was diagnosed by Gd-EOB-DTPA-enhanced MRI in 18 patients. MRE-LSM and T1–T2 maps were evaluated. Patients with SOS were grouped according to the amount of reticular hypointensity on the hepatobiliary phase images.

Results
The mean MRE-LSM in the patients with SOS was 3.14 ± 0.45 kPa, and the control group was 2.6 ± 0.5 kPa (p = 0.01). The mean-corrected T1 (cT1) relaxation time was 1181 ± 151 ms in the SOS group and 1032 ± 129 ms in the control group (p = 0.005). The mean T2 relaxation time was 50.29 ± 3.6 ms in the SOS group and 44 ± 3.9 ms in the control group (p = 0.01). Parenchymal stiffness values were 2.8 ± 0.22 kPa, 3 ± 0.33 kPa, and 3.65 ± 0.28 kPa in patients with mild, moderate, and advanced SOS findings, respectively (p = 0.002). Although cT1 and T2 relaxation times increased with increasing SOS severity, no statistical significance was found.

Conclusions
We observed increased MRE-LSM in patients with SOS after chemotherapy compared to control group. T1 and T2 relaxation times were also useful in diagnosing SOS but were found inadequate in determining SOS severity. MRE is effective in diagnosing SOS and determining SOS severity in patients who cannot receive contrast agents, and it may be useful in the follow-up evaluation of these patients.
Rejuvenated endothelial progenitor cells through overexpression of cellular prion protein effectively salvaged the critical limb ischemia in rats with preexisting chronic kidney disease
Authors: Yeh Jui-Po , Sung Pei‐Hsun , Chiang John Y. , Huang Chi-Ruei , Chen Yi-Ling , Lai Jui-Pin , Sheu Jiunn-Jye 
Published: September 2022

Abstract
Background
This study tested the hypothesis that overexpression of cellular prion protein in endothelial progenitor cells (PrPcOE-EPCs), defined as “rejuvenated EPCs,” was superior to EPCs for salvaging the critical limb ischemia (CLI) induced after 28-day chronic kidney disease (CKD) induction in rat.

Methods and Results
Cell viability and flow cytometric analyses of early/late apoptosis/total-intracellular ROS/cell cycle (sub-G1, G2/M phase) were significantly higher in EPCs + H2O2 than in EPCs that were significantly reversed in PrPcOE-EPCs + H2O2 (all p < 0.001). The protein expressions of inflammation (IL-1ß/IL-6/MMP-9/p-NF-κB) were significantly increased in EPC + TNF-α than in EPCs that were significantly reversed in PrPcOE-EPCs + TNF-α (all p < 0.001). Adult-male SD rats (n = 8/each group) were categorized into group 1 (sham-operated control), group 2 (CKD + CLI), group 3 [CKD + CLI + EPCs by intravenous (0.6 × 105)/intra-muscular (0.6 × 105) injections at 3 h after CLI induction], group 4 (CKD + CLI + PrPcOE-EPCs/dose-administration as group 3) and group 5 (CKD + CLI + siPrnp-EPCs/dose-administration as group 3). By day 14 after CLI induction, the ratio of ischemia to normal blood flow (INBF) in CLI area was highest in group 1/lowest in group 2/significantly higher in group 4 than in groups 3/5 and significantly higher in group 3 than in group 5 (all p < 0.0001). Histopathology demonstrated that the angiogenesis (number of small vessels/CD31 + cells) exhibited a similar trend, whereas the fibrosis/kidney injury score exhibited an opposite pattern of INBF among the groups (all p < 0.0001). The protein expressions of angiogenesis (SDF-1α/VEGF/CXCR4)/cell-stress signaling (p-PI3K/p-Akt/p-m-TOR) were significantly and progressively increased from groups 1–4 that were reversed in group 5 (all p < 0.0001). The protein expressions of fibrotic (p-Smad3/TGF-ß)/oxidative-stress (NOX-1/NOX-2/oxidized-protein)/apoptotic (mitochondrial-Bax/cleaved caspase3/cleaved PARP)/mitochondrial-damaged (cytosolic-cytochrome-C) biomarkers displayed an opposite pattern of INBF among the groups (all p < 0.0001).

Conclusion
PrPcOE-EPCs were superior to EPCs only therapy for salvaging the CLI.