bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment Patterns and Healthcare Outcomes with Collagenase Clostridium Histolyticum vs Surgery in Peyronie's Disease: A Retrospective Claims Database Analysis
Authors: Trost Landon , Huang Huan , Han Xu , Burudpakdee Chakkarin , Hu Yiqun 
Published: March 2021

Abstract

Introduction
Treatments for Peyronie's disease (PD) include surgical management and collagenase clostridium histolyticum (CCH).

Aims
To evaluate PD treatment trends after CCH approval and compare clinical outcomes in CCH- and surgery-treated cohorts.

Methods
Patients newly diagnosed with PD between January 2011 and December 2017 were identified in a U.S. claims database. Cohorts initiating treatment with CCH or surgery between January 2014 and June 2017 were included. Patients were continuously enrolled ≥6 months before and ≥12 months after index date. Post-treatment penile complications and analgesic use were compared 1 year after procedure in propensity score-matched cohorts.

Main outcome measures
The main outcome measures of this study were treatment patterns, penile complications, and analgesic use.

Results
In the newly diagnosed PD cohort, 1,609 patients received CCH and 1,555 patients had surgery. Overall CCH or surgery treatment rate/year increased from 9.8% in 2014 to 15.5% in 2017, with &lt;1% receiving verapamil or interferon. Initial treatment ratios of CCH to surgery increased from approximately 1:1 (2014) to 2:1 (2017). In the unmatched CCH (n = 1,227) and surgery (n = 620) cohorts, more (P &lt; .05) surgery-treated patients received analgesics (particularly opioids), oral PD therapies, vacuum erection devices, and phosphodiesterase-5 inhibitors before the index date. After propensity score matching (n = 620/cohort), newly occurring postprocedural complications during the follow-up period were higher in the surgery cohort (25.3% vs 18.4%, P = .003). The surgery cohort had significantly (P &lt; .05) higher rates of erectile dysfunction (65.0% vs 44.8%), penile pain (17.9% vs 8.9%), and penile swelling (8.1% vs 5.2%) and was more likely to be prescribed opioids (93.3% vs 38.9%; P &lt; .0001) or non-steroidal anti-inflammatory drugs (27.0% vs 20.3%; P = .006).

Conclusion
CCH demonstrated fewer complications and less analgesic use than surgery and was used as the initial therapy for PD twice as often as surgery.
Danish Health Professional Students' Attitudes Toward Addressing Sexual Health: A Cross-Sectional Survey
Authors: Gerbild Helle , Larsen Camilla Marie , Junge Tina , Laursen Birgitte Schantz , Areskoug-Josefsson Kristina 
Published: March 2021

Abstract

Introduction
Danish health professional (HP) students' attitudes toward addressing sexual health are unknown.

Aim
To investigate Danish HP students' attitudes toward addressing sexual health in their future professions, and to assess differences in perceived competences and preparedness between professional programs.

Methods
A Danish national survey of nursing, occupational therapy, and physiotherapy students was conducted. Totally, 1,212 students were invited to respond to an online questionnaire “The Students' Attitudes toward Addressing Sexual Health.”

Main Outcome Measure
The main outcome measures investigated were Danish HP students' attitudes toward addressing sexual health in their future professions, and differences in perceived competences and preparedness depending on the professional program.

Results
A total of 584 students (48%; nursing 44%, occupational therapy 70%, physiotherapy 43%) responded. Mean total score ranged between 63.7 and 66.3 (±8.3–8.8) classifying students in the low-end of the class: “comfortable and prepared in some situations.” No clinically relevant differences were determined between the professional programs with respect to perceived competences and preparedness to address sexual health.

Conclusion
In the field of addressing sexual health, most Danish HP students reported positive attitudes and a need for basic knowledge, competences, communication training, and education.
Expression of MicroRNAs (miR-15b, miR-16, miR-138, miR-221, and miR-222) as Biomarkers of Endothelial Corpus Cavernosum Dysfunction in a Diabetic Alcoholic Murine Model
Authors: Tiraboschi Ricardo Brianezi , Neto Fermino Sanches Lizarte , da Cunha Tirapelli Daniela Pretti , de Bessa Jose , Miranda Eduardo Paula , de Assis Cirino Mucio Luiz , Tirapelli Luis Fernando , Tucci Silvio , Molina Carlos Augusto Fernandes 
Published: March 2021

Abstract

Introduction
MicroRNAs (miRNAs) are short noncoding RNA molecules that regulate gene expression and are related to endothelial dysfunction (EnD). Recently, miRNAs have also been explored as potential biomarkers and target molecular therapy of erectile dysfunction (ED). Could the miRNAs be the tip of the iceberg of chronic arterial disease foreshadowed by the ED?

Aim
To investigate the expression of miR-15b, miR-16, miR-138, miR-221, and miR-222 in corpus cavernosum (CC) and peripheral blood in a rat model of endothelium dysfunction secondary to diabetes (DM) and alcohol consumption to assess potential endothelial lesion biomarkers.

Methods
Twenty males Wistar rats were divided into 4 groups: control group (C), alcohol consumption group (A), diabetic group (D), diabetic-alcohol consumption group (D + A). DM was alloxan-induced and alcohol consumption was through progressive increase of ethanol concentration in drinkable water. After 7 weeks, miRNAs expressions from CC and blood sample were evaluated by real-time PCR. Functional assessment of CC was performed in an acetylcholine endothelium-dependent relaxation pharmacological study.

Main Outcome Measure
miRNA expression in CC and blood were evaluated; pharmacological study in CC strips was conducted to validate EnD.

Results
We found that 3 miRNAs (miR-16, miR-221, and miR-222) were downregulated in the CC in the D+A group, while all 5 miRNAs were downregulated in the blood of D and D + A groups. The endothelium-dependent relaxation induced by acetylcholine was significantly decreased in groups A, D, and D + A. Diagnostic accuracy estimated by AUC, to discriminating groups A, D, and D + A from controls, was superior to &gt;0.9 in all plasmatic miRNAs.

Conclusion
miRNAs downregulation was identified in both CC and blood notably in DM associated with alcohol consumption animals (D + A), the greatest endothelial injury potential group. Serum miRNAs have also demonstrated high diagnostic accuracy properties in predicting CC relaxation dysfunction labeling EnD.
Efficacy and Safety of Avanafil in Chinese Subjects With Erectile Dysfunction: A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial
Authors: Jiang Hui , Lin Haocheng , Li Fubiao , Dai Yutian , Zhang Xiangsheng , Jiang Tao , Deng Junhong 
Published: March 2021

Abstract

Introduction
The incidence of erectile dysfunction (ED) increases with age in mainland China and phosphodiesterase 5 inhibitors (PDE5i) are the major drugs used for its treatment.

Aim
To determine the efficacy and safety of Chinese developed avanafil as therapy for ED in China.

Methods
This phase III trial was carried out in 7 medical centers in China. Eligible subjects suffering from ED were allocated randomly into 3 groups (ratio 1:1:1) and orally received a placebo, 100 or 200 mg avanafil for a total of 12 weeks.

Main Outcome Measures
The primary endpoint was changes in erectile function (EF) domain scores according to the International Index of EF (IIEF) questionnaire from baseline to week 12 of therapy. Secondary endpoints assessments were changes in the response rates of SEP, Q2 and Q3; changes in IIEF other domain scores. Safety evaluation monitored treatment-emergent adverse events (TEAEs), serious TEAEs, laboratory test results, vital signs and electrocardiographs.

Results
Of 218 randomized ED subjects, 182 (83.5%) completed the study. After 12-week therapy, alterations from baseline of the mean IIEF-EF domain scores in the 100 mg and 200 mg groups were greater than for the placebo (all P &lt; .05) group. The changes in mean SEP Q2 response rates from baseline to week 12 in the placebo, 100 mg and 200 mg groups were 5.4%, 22.3% and 22.1%, and SEP Q3 response rate were 22.7%, 42.6% and 38.1%, respectively. Avanafil treatment (regardless of dose) improved EF vs placebo for most of other secondary efficacy endpoints studied (all P &lt; .05). No differences were detected in efficacy endpoints between the 100 and 200 mg dosage groups (all P &gt; .05) or in the incidence of TEAEs and drug-related TEAEs among the 3 groups (all P &gt; .05).

Conclusion
Avanafil (100 or 200 mg) was effective and generally well tolerated in Chinese subjects with ED.
Treatment of hyperglycemia not associated with NAFLD improvement in children with type 2 diabetes mellitus
Authors: Beauchamp Giovanna , Barr Mary M. , Vergara Ariana , Ashraf Ambika , Bril Fernando 
Published: March 2021

Background and objectives:
Nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM) have become public health problems in the pediatric population. However, the relationship between these two conditions is not well understood. The primary objective of this study was to assess whether treatment of hyperglycemia in obese, treatment-naive children with type 2 diabetes (T2DM) was asso-ciated with an improvement of surrogate markers of NAFLD.

Materials and methods:
This retrospective, longitudinal study included 151 obese children with a diag-nosis of T2DM (Age: 14 ± 1 years, 72% female children, BMI: 98.6th percentile, and A1c: 10.3 ± 0.2%). Clinical/demographic information was collected before patients started any diabetes treatment and 1 and 3 years after starting metformin and/or insulin therapy.

Results:
Forty-eight patients (32%) had abnormal ALT/AST (i.e., >40 U/L), suggestive of NAFLD. After 1 year of therapy, there were no significant differences in plasma ALT among patients started on insulin, metformin, or combination: 5±4 vs. -10 ± 3 vs. -2±2 IU/L, respectively, P = .07. Of note, changes in plasma ALT were small, despite a significant reduction of A1c in patients prescribed insulin (alone or with metformin): -2.8 ± 1.0%, P = .01, and -2.7 ± 0.3%, P < .001, respectively. In line with this, no significant correlations were found between changes in A1c and plasma aminotransferases. In contrast, changes in plasma AST/ALT were more strongly associated with BMI changes (r = 0.32, P < .001, and r = 0.19, P = .04, respectively). Similar results were observed after 3 years of follow-up.

Conclusions:
Nonalcoholic fatty liver disease is highly prevalent in obese children with T2DM. Treatment of hyperglycemia with metformin and/or insulin did not result in any significant improvement in sur-rogate markers of NAFLD (i.e., plasma aminotransferases). While changes in ALT and/or AST may not perfectly reflect histological changes in NAFLD, our findings suggest that the treatment of hyperglycemia per se may not be associated with NAFLD improvement.
Prognostic Significance of Concomitant Superficial Vein Thrombosis in Patients with Deep Vein Thrombosis of the Lower Limbs
Authors: Dubois-Silva Álvaro , Barbagelata-López Cristina , Piñeiro-Parga Patricia , Francisco Iria , Falgá Conxita , Tirado Raimundo , Suriñach José María , Vela Jerónimo Ramón , Mella Carmen , Quere Isabelle , Siniscalchi Carmine , Monreal Manuel ,   the RIETE Investigators
Published: March 2021

Abstract
Background The prognostic significance of concomitant superficial vein thrombosis (SVT) in patients with lower-limb deep vein thrombosis (DVT) has not been consistently evaluated.
Methods We used the RIETE (Registro Informatizado de Enfermedad TromboEmbólica) registry to compare the rates of subsequent pulmonary embolism (PE), recurrent DVT, major bleeding or death in patients with lower-limb DVT, according to the presence or absence of concomitant SVT.
Results From March 2015 to May 2020, there were 8,743 patients with lower-limb DVT. Of these, 745 (8.5%) had concomitant SVT. Most patients (97.4% in both subgroups) received anticoagulant therapy (median duration: 138 vs. 147 days). During follow-up (median: 193 vs. 210 days), 156 (1.8%) patients developed subsequent PE, 336 (3.8%) had recurrent DVT, 201 (2.3%) had major bleeding and 844 (9.7%) died. Patients with concomitant SVT had a higher rate of subsequent PE (rate ratio [RR]: 2.11; 95% confidence interval [95%CI]: 1.33–3.24) than those with isolated DVT, with no significant differences in the rates of recurrent DVT (RR: 0.80; 95%CI: 0.50–1.21), major bleeding (RR: 0.77; 95%CI: 0.41–1.33) or death (RR: 0.81; 95%CI: 0.61–1.06). On multivariable analysis, patients with DVT and SVT concomitantly were at increased risk of subsequent PE during anticoagulation (adjusted hazard ratio [HR]: 2.23; 95%CI: 1.22–4.05) and also during the entire follow-up period (adjusted HR: 2.33; 95%CI: 1.49–3.66).
Conclusion Patients with lower-limb DVT and SVT concomitantly are at increased risk of developing PE. Further studies are needed to externally validate our findings and to determine if these patients could benefit from a different management strategy.
Lung Resection in Children with Necrotizing Pneumonia: Outcome and Follow-up
Authors: Frybova Barbora , Koucky Vaclav , Pohunek Petr , Cejnarova Kristyna , Coufal Stepan , Kokesova Alena , Dotlacil Vojtech , Petrasova Natalia , Pos Lucie , Snajdauf Jiri , Hlava Stepan , Polivka Natali , Rygl Michal 
Published: March 2021

Abstract
Introduction The number of patients with necrotizing pneumonia has increased in recent years. The aim of this study is to review the incidence, management, and outcome of pediatric necrotizing pneumonia requiring surgical therapy and to prove that lung resection results in favorable development of patients. We hypothesize that overall lung function in children after lung resection does not differ from that of the healthy population.
Materials and Methods A retrospective tertiary referral center study with a prospective follow-up spirometric study of patients with necrotizing pneumonia managed between January 2010 and December 2019 was performed.
Results The study cohort consisted of 1,295 patients admitted to the pediatric department for community-acquired pneumonia; 47 patients developed necrotizing pneumonia, 36 of whom underwent parenchymal lung resection. A 5-year rise in the occurrence of necrotizing pneumonia requiring resection was 77%, with a significant increase in the last 3 years (p < 0.05). The median age at the time of surgery was 32.5 (interquartile range [IQR]: 32.25) months. Streptococcus pneumoniae was the most prevalent pathogen (83%), although 53.3% of these patients were vaccinated against the agent. In 67% of patients, preresection procedures were performed: drainage of pneumothorax (17%), drainage of empyema (46%), drainage of empyema with use of alteplase (25%), and thoracoscopic decortication (12%). Surgical procedures included lobectomy (72.2%), wedge resection (13.9%), bilobectomy (8.3%), and pneumonectomy (5.6%). The postoperative complication was bronchopleural fistula in three patients. There were two (5.5%) postoperative deaths due to multiple organ failure. The follow-up spirometry was performed 43.3 (median, IQR 23.8–66.7) months after surgical intervention. Normal lung function was detected in 35 (64.8%) patients, restrictive pattern in 6 (11.1%) patients, obstructive pattern in 11 (20.4%) patients, and combined in 2 (3.7%) patients.
Conclusion The number of patients with necrotizing pneumonia requiring resection has increased significantly in the last 3 years (p < 0.05). Aggressive surgical treatment results in significant clinical improvement in most cases and favorable lung function outcome. Long-term follow-up showed normal spirometry in 64.8% of cases.
Correlation between Common Channel Length and Urethral Length in Cloacal Malformations
Authors: Abdelmalak Abokandil Mohamed , Waheeb Saber , Eltagy Gamal , Khairi Ahmad , Farghaly Yasmine , Aly Salmaa 
Published: March 2021

Abstract
Introduction This research aimed to study the relationship between common channel length and urethral length in cloaca patients by different diagnostic modalities and the ability of common channel length to predict the urethral length.
Materials and Methods The study was conducted on 30 cases of cloaca managed at Alexandria University Children Hospital and Cairo University Children Hospital from August 2018 to December 2019. Preoperative assessment included cystovaginoscopy and magnetic resonance imaging (MRI) studies with a recording of common channel length and urethral length by each modality.
Results There is substantial similarity between MRI and cystoscopy in measuring common channel length; 11 patients had common channel length 1 to 3 cm by cystoscopy. It is the same number by MRI measurement. Nineteen patients had common channel length 3 to 5 cm by cystoscopy and MRI. In total, 16 had urethral length <1.5 cm by MRI, while 14 patients with urethral length <1.5 cm by cystoscopy. However, there is a moderate negative correlation by MRI between common channel length and urethral length, while by cystovaginoscope, there is no significant correlation between common channel length and urethral length.
Conclusion Applying MRI or cystoscopy in the preoperative assessment of cloaca cases is equivalent to measuring common channel length, not measuring urethral length. Besides that, the common channel length cannot predict the urethral length.
Effective stiffness and thermal expansion of three-phase multifunctional polymer electrolyte coated carbon fibre composite materials
Authors: Schutzeichel M O H , Kletschkowski T , Monner H P 
Published: March 2021

Abstract
Multifunctional composites including polymer electrolyte coated carbon fibres and polymer matrix systems gained recent interest in light-weight design related research areas. Compared to classical fibre reinforced plastics, the interphase, made by electropolymerisation on the fibre surface, represents a new, third material phase. The coating serves as ion-conducting separator in structural batteries and as insulating layer in energy transmitting multifunctional composites. The importance of this study is related to the fact, that multifunctional applications, based on such composites, are exposed to temperature changes in many cases. The coating material, acting as thin interphase, shows a significant temperature dependant Young’s modulus, determining the overall macroscopic behaviour under thermal loads. The new influences on the effective elastic properties of the composite are determined in this work in a 3D microstructural simulation approach based on a unit cell geometry. For the first time, the resulting effective properties are discussed towards the state of research and future work. First, the effective elastic stiffness is computed by isothermal virtual material testing, applying unit strain modes on the unit cell. Second, a uniform temperature change is applied and the effective thermal expansion coefficients are computed. The results show that a change of stiffness in the coating domain has a great influence on the effective stiffness in the transversal isotropic plane. The effective thermal expansion of the composite is also highly sensitive to the thermal expansion behaviour of the coating phase. Main conclusions are drawn towards multiphysical material simulation: Influences of the coating material properties have to be taken into account to compute effective properties. In particular, it is necessary to include the temperature dependant stiffness and the coefficients of thermal expansion of the interphase, which affect effective properties significantly. A thermo-mechanic coupled microscale model is needed to represent in-situ properties of such composites for applications with heat exposure.
A Cultural Dance Program Improves Hypertension Control and Cardiovascular Disease Risk in Native Hawaiians: A Randomized Controlled Trial
Authors: Kaholokula Joseph Keawe'aimoku , Look Mele , Mabellos Tricia , Ahn Hyeong Jun , Choi So Yung , Sinclair Ka'imi A , Wills Thomas A , Seto Todd B , de Silva Māpuana 
Published: March 2021

Abstract

Background
Native Hawaiians have higher hypertension (HTN) and cardiovascular disease (CVD) rates than non-Hispanic whites, calling for culturally responsive interventions to close this gap.

Purpose
We tested the effects of a 6-month behavioral intervention, a cultural dance program based on hula (the customary dance of Hawai'i), for improving blood pressure (BP) and CVD risk among Native Hawaiians with uncontrolled HTN.

Methods
In a randomized controlled trial, we tested the effects of the hula-based intervention among 263 Native Hawaiians with uncontrolled HTN (systolic ≥ 140 or ≥ 130 mmHg if diabetes) and no CVD at enrollment. All participants received a brief culturally tailored heart health education before random assignment to the hula-based intervention (n = 131) or the education-only waitlist control (n = 132). Intervention received hula lessons and group-based activities for 6 months. Control received only 1-week education through 6 months.

Results
Intervention yielded greater reductions in systolic (−15.3 mmHg) and diastolic (−6.4 mmHg) BP than control (−11.8 and −2.6 mmHg, respectively) from baseline to 6 months (p &lt; .05). At 6 months, 43% of intervention participants compared to 21% of controls achieved a HTN stage &lt;130/80 mmHg (p &lt; .001). The 10-year CVD risk reduction was two times greater for the intervention group than the control group based on the Framingham Risk Score calculator. All improvements for intervention participants were maintained at 12 months.

Conclusions
This trial represents one of the few rigorously conducted examinations of an Indigenous practice leveraged for health promotion, with implications for other ethnic populations.
Decoding gene therapy: Current impact and future considerations for health-system and specialty pharmacy practice
Authors: Canfield Scott L 
Published: March 2021

Abstract

Purpose
To provide health systems with baseline knowledge on existing and pipeline gene therapy treatments, including considerations that health-system pharmacies and specialty pharmacy programs may reference when evaluating and implementing services around gene therapies.

Summary
Advancements in research and biotechnology have recently led to the development and launch of the first commercially available gene therapy treatments in the United States. These treatments have the ability to significantly alter and even effectively cure diseases. Alongside these significant advances and clinical benefits, these therapies present unique challenges due to their cost and complexity. Given the large number of additional gene therapy treatments that are currently in late-stage clinical development, stakeholders across the healthcare industry must increasingly adapt and ready themselves to meet these challenges. The diagnosis and treatment of patients with diseases being targeted by gene therapies largely occurs within health systems, and judging by the gene therapy pipeline, this trend is likely to continue. To prepare for these novel treatments, health systems must understand and consider the methods in which gene therapies are developed, procured, reimbursed, administered, and monitored.

Conclusion
The future of health-system pharmacy practice must include comprehensive gene therapy services and stakeholder engagement strategies to ensure patients have access to these life-changing treatments.