bluuebunny/crossref_metadata_2025_split huggingface dataset:
Early outcomes of novel Temren atherectomy device combined with drug-coated balloon angioplasty for treatment of femoropopliteal lesions
Authors: Yiğit Görkem 
Published: June 2021

Objectives In this study, perioperative properties and early outcomes of patients who underwent combined Temren rotational atherectomy (RA) and drug-coated balloon (DCB) angioplasty treatment for complex femoropopliteal lesions in a single center were reported. Methods Between June 2019 and February 2020, 40 patients who underwent combined Temren RA and DCB treatment due to critical lower limb ischemia or claudication-limiting daily living activities were retrospectively evaluated. Results The mean age of patients was 73.2 ± 7.8 years and the majority of the patients were male (65%). Of the patients, 17 had critical limb ischemia and 23 had lifestyle-limiting claudication. Pathologies were total occlusion in 33 limbs and critical stenosis in seven limbs. Nine patients previously underwent endovascular intervention or surgery. The mean total occlusion length was 140.9 ± 100.9 (range, 20–360) mm in patients with chronic total occlusion. There was an additional iliac artery pathology in 5 and below the knee pathology in 8 patients. Rotational atherectomy was possible in all cases. Flow-limiting dissection was seen in six patients (15%). Provisional stent was performed to these patients. Following Temren RA, all patients underwent DCB. Adequate vascular lumen (less than 30% stenosis) was provided in all patients and the symptoms regressed. No distal embolization was encountered. Access site complications (17.5%) were small hematoma in four patients, ecchymosis in two patients, and pseudoaneurysm of the femoral artery in one patient. The mean follow-up was 13.55 ± 4.2 (range, 1–18) months. Re-occlusion was seen in three patients (7.5%) ( n = 2 at 2 months and n = 1 at 4 months). Of these patients, two had required open revascularization via femoropopliteal bypass graft with common, superficial femoral, and popliteal artery endarterectomy and one had required femoro-posterior tibial artery bypass. Four minor toe amputations (10%) were performed to reach complete wound healing in the critical limb ischemia patients. A below-knee amputation was performed in a 94-year-old patient with long segment stenosis at the end of a 1-month follow-up period. There was no mortality after follow-ups. The Kaplan–Meier estimator estimated the rate of freedom from target lesion revascularization (TLR) which was 92.3%. The decrease in the Rutherford levels after the procedure was found to be statistically significant in 36 patients ( p < 0.001). The increase in the ankle–brachial index after the procedure was found to be statistically significant in 36 patients ( p < 0.001). Conclusions Combined use of Temren RA with adjunctive DCB is safe and effective method with high rates of primary patency and freedom from TLR and low rates of complication in the treatment of femoropopliteal lesions.
Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel preparation in patients with baseline renal impairment or diabetes: subanalysis of a randomized, controlled trial
Authors: Mankaney Gautam N. , Ando Masakazu , Dahdal David N. , Burke Carol A. 
Published: June 2021

Background: Selecting a bowel preparation for patients with renal impairment or diabetes requires special consideration. We aimed to describe the effect of baseline renal impairment or diabetes on the safety, efficacy, and tolerability of low-volume sodium picosulfate, magnesium oxide, and citric acid (SPMC) ready-to-drink oral solution bowel preparation. Methods: A post hoc secondary analysis was performed from a randomized, assessor-blinded study of SPMC oral solution bowel preparation in participants with mild or moderate baseline renal impairment or diabetes. Primary efficacy endpoint (‘responders’) was the proportion of participants with ‘excellent’ or ‘good’ ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of ascending colon cleansing from the Boston Bowel Preparation Scale (BBPS), and selected results from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs), adenoma detection, and laboratory evaluations. Results: Similar overall colon cleansing was demonstrated in the subgroups, with >85% of participants in any subgroup rated as responders by the AS, and >92% of participant responders by the BBPS. Most participants reported a tolerable bowel preparation, regardless of baseline renal impairment or diabetes history. Safety of SPMC oral solution was similar between all subgroups and the overall cohort. For the mild renal impairment, moderate renal impairment, and diabetes subgroups, respectively, commonly reported, drug-related AEs were nausea (2.6%, 5.3%, 1.4%) and headache (2.2%, 2.6%, 4.3%). Conclusions: Ready-to-drink SPMC oral solution demonstrated efficacious colon cleansing in patients with baseline mild/moderate renal impairment or diabetes, with a tolerable bowel preparation reported by most. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03017235
Percutaneous nephrolithotomy outcomes based on body mass index: A 5-year retrospective study in an Indonesian tertiary hospital
Authors: Wibowo DNSA , Soebadi Doddy M , Rizaldi Fikri 
Published: June 2021

Objectives: The aim of this study was to evaluate the impact of body mass index (BMI) on percutaneous nephrolithotomy (PCNL) outcomes and complications for nephrolithiasis. Patients and methods: Patients with a history of PCNL surgery from 2012 to 2017 in Dr. Soetomo General-Academic Hospital were retrospectively evaluated. Patients were then categorized into four groups: underweight (BMI <18.5 kg/m2), normal (BMI 18.5 to 24.99 kg/m2), overweight (BMI ⩾25–29.9 kg/m2), and obese (BMI ⩾30 kg/m2). The association between BMI, subjects’ characteristics, length of stay, stone-free rate (SFR), and complications were analyzed using one-way analysis of variance (ANOVA) and univariate logistic regression. Results: The study included 430 male patients (58%) and 310 female patients (42%). They were classified based on their BMI into underweight ( n = 5, 1%), normal weight ( n = 291, 39%), overweight ( n = 271, 37%), and obese ( n = 173, 23%) groups. The underweight BMI group had a higher average blood loss ( p=0.002) compared to the other groups; however, the univariate logistic regression showed that BMI had no significant effect on SFR ( p=0.491). Conclusion: PCNL is safe and feasible to be performed in patients with different BMI as obesity has no impact on the outcomes and complications associated with PCNL. Level of evidence 3
Early Recovery of Walking Ability in Patients After Total Knee Arthroplasty Using a Hip-Wearable Exoskeleton Robot: A Case-Controlled Clinical Trial
Authors: Koseki Kazunori , Mutsuzaki Hirotaka , Yoshikawa Kenichi , Iwai Koichi , Hashizume Yuko , Nakazawa Ryo , Kohno Yutaka 
Published: June 2021

Introduction: The Honda Walking Assist (HWA) is a hip-wearable exoskeleton robot for gait training that assists in hip flexion and extension movements to guide hip joint movements during gait. This study aimed to evaluate the effects of walking exercises with HWA in patients who underwent total knee arthroplasty (TKA). Materials and Methods: This study involved 10 patients (11 knees) in the HWA group and 11 patients (11 knees) in the control group who underwent conventional physical therapy. The patients assigned to the HWA group underwent a total of 17-20 gait training sessions, each lasting approximately 20 min from week 1 to 5 following TKA. Self-selected walking speed (SWS), maximum walking speed (MWS), range of motion (ROM), knee extension and flexion torque, and Western Ontario and McMaster Universities Osteoarthritis Index subscales of pain (WOMAC-p) and physical function (WOMAC-f) scores were measured preoperatively, at 2, 4, and 8 weeks following TKA. Results: Interventions were successfully completed in all patients, with no severe adverse events. A significant difference was noted in the time × group interaction effect between preoperative and week 2 SWS and MWS. Regarding knee function, there was a significant difference in the time × group interaction between preoperative and week 2 active ROM extension; however, no significant difference in knee torque, WOMAC-p, and WOMAC-f scores were observed. In the between-group post hoc analysis, WOMAC-f in the HWA group was higher than that in the control group at week 8. Discussion: Although the control group showed a temporary reduction in SWS and MWS 2 weeks after TKA, the HWA group did not. These results suggest that HWA intervention promotes early improvement in walking ability after TKA. Conclusions: The gait training using HWA was safe and feasible and could be effective for the early improvement of walking ability in TKA patients.
Effect of Capsular Closure After Hip Arthroscopy for Femoroacetabular Impingement Syndrome on Achieving Clinically Meaningful Outcomes: A Meta-analysis of Prospective and Comparative Studies
Authors: Kunze Kyle N. , Vadhera Amar , Devinney Annie , Nwachukwu Benedict U. , Kelly Bryan T. , Nho Shane J. , Chahla Jorge 
Published: June 2021

Background: Recent literature has demonstrated conflicting evidence as to whether capsular closure after hip arthroscopy for femoroacetabular impingement syndrome (FAIS) results in superior outcomes compared with capsulotomy without repair. Additionally, these studies have not explored the effect of capsular management on clinically significant outcome improvement. Purpose: To perform a meta-analysis of prospective and comparative studies to determine whether capsular management influences the rate of clinically significant outcome improvement after hip arthroscopy for FAIS. Study Design: Systematic review; Level of evidence, 3. Methods: PubMed, OVID/Medline, EMBASE, and Cochrane databases were queried in September 2020 for studies with evidence levels 1 to 3 that directly compared capsular management cohorts and reported rates of achieving the minimal clinically important difference (MCID) at a minimum follow-up of 2 years. Studies of level 4 evidence, those not describing or directly comparing capsular management techniques as well as those not reporting the MCID were excluded. Methodological quality was assessed using the methodological index for nonrandomized studies tool. Mantel-Haenszel fixed-effects models were constructed to quantitatively evaluate the association between capsular management and achievement of the MCID by generating effect estimates in the form of relative risk (RR) with 95% CIs. Results: A total of 6 studies with 1611 patients were included. The overall pooled rate of MCID achievement for the modified Harris Hip Score (mHHS), Hip Outcome Score Activities of Daily Living (HOS-ADL), and HOS Sports Subscale (HOS-SS) were 84.4%, 80.3%, and 82.5%, respectively, at a mean follow-up of 40.8 months (range, 24-87.6 months). Capsular closure was associated with a significantly higher rate of MCID achievement for the mHHS (RR, 1.06; 95% CI, 1.01-1.10; P = .001) and trended toward statistical significance for the HOS-ADL (RR, 1.11; 95% CI, 1.0-1.24; P = .055) and the HOS-SS (RR, 1.09; 95% CI, 0.99-1.21; P = .094). Conclusion: Although capsular closure appeared to result in higher rates of clinically significant outcome improvement in hip function, there was no definitively increased likelihood of achieving clinically significant improvement in relevant hip outcome scores with capsular closure.
Changes in carnitine levels through induction chemotherapy in head and neck cancer patients as a potential cause of therapy-related malaise
Authors: Ito Tatsuya , Tsukahara Kiyoaki , Sato Hiroki , Shimizu Akira , Okamoto Isaku 
Published: June 2021

Abstract
Background
Carnitine is related to malaise, and cisplatin is associated with decreased carnitine. The purpose of this study was to elucidate the effects of one course of induction chemotherapy (IC) for head and neck cancer on blood carnitine levels, focusing on free carnitine (FC).

Methods
This single-center prospective study investigated 20 patients diagnosed with primary head and neck cancer who underwent IC with cisplatin, docetaxel, and 5-fluorouracil. FC, acylcarnitine (AC), and total carnitine (TC) levels were measured before starting therapy and on Days 7 and 21 after starting IC. In addition, malaise was evaluated before and after therapy using a visual analog scale (VAS).

Results
All subjects were men and the most common primary cancer site was the hypopharynx (9 patients). FC levels before starting therapy and on Days 7 and 21 were 47.7 ± 2.2 μM/mL, 56.7 ± 2.2 μM/mL, and 41.1 ± 1.9 μM/mL, respectively. Compared with the baseline before starting therapy, FC had significantly decreased on Day 21 (p = 0.007). AC levels before starting therapy and on Days 7 and 21 were 12.5 ± 1.2 μM/mL, 13.6 ± 1.4 μM/mL, and 10.7 ± 0.7 μM/mL, respectively. TC levels before starting therapy and on Days 7 and 21 were 60.2 ± 2.5 μM/mL, 70.2 ± 3.3 μM/mL, and 51.7 ± 2.3 μM/mL, respectively. No significant differences in AC, TC or VAS were seen before the start of therapy and on Day 21.

Conclusions
After IC, a latent decrease in FC occurred without any absolute deficiency or subjective malaise.
Survival analysis and influence of the surgical aggression of a cohort of orthopedic and trauma patients in a non-controlled spread COVID-19 scenario
Authors: Corella Fernando , Rosales Roberto S. , Guzman Domenech David , Cañones Martín Miguel , Larrainzar-Garijo Ricardo 
Published: June 2021

Abstract
Background
Determining the infection rate and mortality probability in healthy patients who have undergone orthopedic and trauma surgeries (OTS) during a period of uncontrolled COVID-19 transmission may help to inform preparations for future waves. This study performed a survival analysis in a cohort of non-infected OTS patients and determined the effect of COVID-19 on mortality.

Methods
This observational study included 184 patients who underwent OTS in the month before surgical activities ceased and before the implementation of special measures. Four groups of surgery (GS) were established based on the location of the surgery and the grade of inflammation produced. Crude risk of infection and infection rates were assessed. Survival and failure functions by GS were analyzed. Comparison of the Kaplan-Meier survival curves by GS was assessed. Cox regression and Fine-Gray models were used to determine the effect of different confounders on mortality.

Results
The crude risk of COVID-19 diagnosis was 14.13% (95% CI: 9.83–19.90%). The total incidence rate was 2.67 (1000 person-days, 95% CI: 1.74–3.91). At the end of follow-up, there was a 94.42% chance of surviving 76 days or more after OTS. The differences in K-M survivor curves by GS indicated that GS 4 presented a lower survival function (Mantel-Cox test, p = 0.024; Wilcoxon-Breslow test, p = 0.044; Tarone-Ware test, p = 0.032). One of the best models to determine the association with mortality was the age-adjusted model for GS, high blood pressure, and respiratory history, with a hazard ratio of 1.112 in Cox regression analysis (95% CI: 1.005–1.230) and a sub hazard ratio of 1.111 (95% CI: 1.046–1.177) in Fine-Gray regression analysis for competitive risk.

Conclusions
The infection risk after OTS was similar to that of the general population in a community transmission area; the grade of surgical aggression did not influence this rate. The survival probability was extremely high if patients had not previously been infected. With higher grades of surgical aggression, the risk of mortality was higher in OTS patients. Adjusting for age and other confounders (e.g., GS, high blood pressure and respiratory history) was associated with higher mortality rates.
Changes in the management of urinary tract infections in women: impact of the new recommendations on antibiotic prescribing behavior in France, between 2014 and 2019
Authors: Piraux Arthur , Faure Sébastien , Naber Kurt G. , Alidjanov Jakhongir F. , Ramond-Roquin Aline 
Published: June 2021

Abstract
Background
Urinary tract infections (UTIs) are among the most common infections that require antibiotic therapy. In December 2015, new guidelines for UTI management were published in France with the aim of reducing antibiotic misuse and the risk of antimicrobial resistance.

Objectives
To analyze changes in antibiotic prescribing behavior for acute uncomplicated UTI in women in France from 2014 to 2019.

Methods
Retrospective study using data extracted from the medico-administrative database ‘OpenMedic’ that is linked to the French National Health Data System and collects data on the reimbursement of prescribed drugs. The analyses focused on the number of boxes of antibiotics delivered by community pharmacies, the molecule class, and the prescriber’s specialty.

Results
Overall, antibiotic dispensing by community pharmacies increased by 2% between 2014 and 2019, but with differences in function of the antibiotic class. The use of antibiotics recommended as first-line and second-line treatment increased (+ 41% for fosfomycin and + 7430% for pivmecillinam). Conversely, the dispensing of lomefloxacin and norfloxacin decreased by 80%, and that of ciprofloxacin by 26%. Some antibiotics were mostly prescribed by general practitioners (lomefloxacin, pivmecillinam) and others by secondary care physicians (ofloxacin). Dispensing increased for antibiotics prescribed by secondary care physicians (+ 13% between 2014 and 2019) and decreased for antibiotics prescribed by GPs (− 2% for the same period).

Conclusion
These data suggest that the new recommendations are followed, as indicated by the increased prescription of fosfomycin and pivmecillinam and decreased prescription of fluoroquinolones. However, the efficient transmission and implementation of new recommendations by practitioners requires time, means and dedicated tools.
Accessing and utilising gender-affirming healthcare in England and Wales: trans and non-binary people’s accounts of navigating gender identity clinics
Authors: Wright Talen , Nicholls Emily Jay , Rodger Alison J , Burns Fiona M , Weatherburn Peter , Pebody Roger , McCabe Leanne , Wolton Aedan , Gafos Mitzy , Witzel T. Charles 
Published: June 2021

AbstractBackgroundTransgender, or trans, people experience a number of barriers to accessing gender-affirming healthcare and have a range of barriers and facilitators to primary care and specialist services, commonly citing discrimination and cisgenderism playing a central role in shaping accessibility. The pathway through primary care to specialist services is a particularly precarious time for trans people, and misinformation and poorly applied protocols can have a detrimental impact on wellbeing.MethodWe recruited trans participants from an HIV Self-Testing Public Health Intervention (SELPHI) trial to interviews which explored contemporary gender-affirming service experiences, with an aim to examine the path from primary care services through to specialist gender services, in the UK.ResultsA narrative synthesis of vignettes and thematic analysis of in-depth qualitative interviews were conducted with twenty trans individuals. We summarise positive and negative accounts of care under three broad categories: Experiences with primary care physicians, referrals to gender identity clinics (GICs), and experiences at GICs.ConclusionsWe discuss implications of this research in terms of how to improve best practice for trans people attempting to access gender-affirming healthcare in the UK. Here we highlight the importance of GP’s access to knowledge around pathways and protocols and clinical practice which treats trans patients holistically.
Combination of computed tomography imaging-based radiomics and clinicopathological characteristics for predicting the clinical benefits of immune checkpoint inhibitors in lung cancer
Authors: Yang Bin , Zhou Li , Zhong Jing , Lv   Tangfeng , Li Ang , Ma Lu , Zhong Jian , Yin Saisai , Huang Litang , Zhou Changsheng , Li Xinyu , Ge Ying Qian , Tao Xinwei , Zhang Longjiang , Son Yong , Lu Guangming 
Published: June 2021

AbstractBackgroundIn this study, we tested whether a combination of radiomic features extracted from baseline pre-immunotherapy computed tomography (CT) images and clinicopathological characteristics could be used as novel noninvasive biomarkers for predicting the clinical benefits of non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICIs).MethodsThe data from 92 consecutive patients with lung cancer who had been treated with ICIs were retrospectively analyzed. In total, 88 radiomic features were selected from the pretreatment CT images for the construction of a random forest model. Radiomics model 1 was constructed based on the Rad-score. Using multivariate logistic regression analysis, the Rad-score and significant predictors were integrated into a single predictive model (radiomics nomogram model 1) to predict the durable clinical benefit (DCB) of ICIs. Radiomics model 2 was developed based on the same Rad-score as radiomics model 1.Using multivariate Cox proportional hazards regression analysis, the Rad-score, and independent risk factors, radiomics nomogram model 2 was constructed to predict the progression-free survival (PFS).ResultsThe models successfully predicted the patients who would benefit from ICIs. For radiomics model 1, the area under the receiver operating characteristic curve values for the training and validation cohorts were 0.848 and 0.795, respectively, whereas for radiomics nomogram model 1, the values were 0.902 and 0.877, respectively. For the PFS prediction, the Harrell’s concordance indexes for the training and validation cohorts were 0.717 and 0.760, respectively, using radiomics model 2, whereas they were 0.749 and 0.791, respectively, using radiomics nomogram model 2.ConclusionsCT-based radiomic features and clinicopathological factors can be used prior to the initiation of immunotherapy for identifying NSCLC patients who are the most likely to benefit from the therapy. This could guide the individualized treatment strategy for advanced NSCLC.