bluuebunny/crossref_metadata_2025_split huggingface dataset:
Graft Tensioning in Superior Capsular Reconstruction Improves Glenohumeral Joint Kinematics in Massive Irreparable Rotator Cuff Tears: A Biomechanical Study of the Influence of Superior Capsular Reconstruction on Dynamic Shoulder Abduction
Authors: Dyrna Felix , Berthold Daniel P. , Muench Lukas N. , Beitzel Knut , Kia Cameron , Obopilwe Elifho , Pauzenberger Leo , Adams Christopher R. , Cote Mark P. , Scheiderer Bastian , Mazzocca Augustus D. 
Published: October 2020

Background: Superior capsular reconstruction (SCR) for massive, irreparable rotator cuff tears has become more widely used recently; however, ideal tensioning of the graft and the influence on joint kinematics remain unknown. Purpose/Hypothesis: The purpose of this study was to assess the effects of graft tensioning on glenohumeral joint kinematics after SCR using a dermal allograft. The hypothesis was that a graft fixed under tension would result in increased glenohumeral abduction motion and decreased cumulative deltoid forces compared with a nontensioned graft. Study Design: Controlled laboratory study. Methods: A total of 10 fresh-frozen cadaveric shoulders were tested using a dynamic shoulder simulator. Each shoulder underwent the following 4 conditions: (1) native, (2) simulated irreparable supraspinatus (SSP) tear, (3) SCR using a nontensioned acellular dermal allograft, and (4) SCR using a graft tensioned with 30 to 35 N. Mean values for maximum glenohumeral abduction and cumulative deltoid forces were recorded. The critical shoulder angle (CSA) was also assessed. Results: Native shoulders required a mean (±SE) deltoid force of 193.2 ± 45.1 N to achieve maximum glenohumeral abduction (79.8° ± 5.8°). Compared with native shoulders, abduction decreased after SSP tears by 32% (54.3° ± 13.7°; P = .04), whereas cumulative deltoid forces increased by 23% (252.1 ± 68.3 N; P = .04). The nontensioned SCR showed no significant difference in shoulder abduction (54.1° ± 16.1°) and required deltoid forces (277.8 ± 39.8 N) when compared with the SSP tear state. In contrast, a tensioned graft led to significantly improved shoulder abduction compared with the SSP tear state ( P = .04) although abduction and deltoid forces could not be restored to the native state ( P = .01). A positive correlation between CSA and maximum abduction was found for the tensioned-graft SCR state ( r = 0.685; P = .02). Conclusion: SCR using a graft fixed under tension demonstrated a significant increase in maximum shoulder abduction compared with a nontensioned graft; however, abduction remained significantly less than the intact state. The nontensioned SCR showed no significant improvement in glenohumeral kinematics compared with the SSP tear state. Clinical Relevance: Because significant improvement in shoulder function after SCR may be expected only when the graft is adequately tensioned, accurate graft measurement and adequate tension of at least 30 N should be considered during the surgical procedure. SCR with a tensioned graft may help maintain sufficient acromiohumeral distance, improve clinical outcomes, and reduce postoperative complications.
Bilateral Central Retinal Artery Occlusion in Infective Endocarditis
Authors: Mohamed Mohamed , Scholle Tahira 
Published: October 2020

Purpose: This report describes a patient with bilateral, sequential central retinal artery occlusions (CRAOs) due to infective endocarditis (IE). Methods: A case report is presented. Results: A 35-year-old man with IE who recently completed a course of intravenous antibiotic therapy presented with sudden right-eye vision loss. Examination revealed hand motion vision, a cherry-red spot in the macula in the right eye, and an embolus in the inferotemporal arcade of the left eye. The diagnosis of right-eye CRAO secondary to IE was made, with the presumed source being his dental caries. The patient was admitted with plans for aortic valve replacement and dental extraction. During his hospitalization, the patient suffered from a CRAO in his left eye, resulting in bilateral loss of vision. Conclusions: IE can have severe embolic complications; prompt diagnosis and treatment medically and surgically are necessary to reduce further morbidity and mortality.
Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study
Authors: Silberstein Stephen , Diamond Merle , Hindiyeh Nada A. , Biondi David M. , Cady Roger , Hirman Joe , Allan Brent , Pederson Susan , Schaeffler Barbara , Smith Jeff 
Published: October 2020

Abstract
Background
PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide–targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment.

Methods
Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32).

Results
A total of 1072 adults received treatment: eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366. The reduction in mean monthly migraine days observed during the first dosing interval (100 mg, − 7.7 days; 300 mg, − 8.2 days; placebo, − 5.6 days) was further decreased after an additional dose (100 mg, − 8.2 days; 300 mg, − 8.8 days; placebo, − 6.2 days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The ≥50% and ≥ 75% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (≥50% MRRs weeks 13–24: 100 mg, 61.0%; 300 mg, 64.0%; placebo, 44.0%; and ≥ 75% MRRs weeks 13–24: 100 mg, 39.3%; 300 mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events.

Conclusion
Eptinezumab 100 mg or 300 mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24 weeks and demonstrated an acceptable safety profile in patients with chronic migraine.

Trial registration
ClinicalTrials.gov (Identifier: NCT02974153). Registered November 23, 2016.
Enhanced MRI-guided radiotherapy with gadolinium-based nanoparticles: preclinical evaluation with an MRI-linac
Authors: Byrne H. L. , Le Duc G. , Lux F. , Tillement O. , Holmes N. M. , James A. , Jelen U. , Dong B. , Liney G. , Roberts T. L. , Kuncic Z. 
Published: October 2020

Abstract
Background
The AGuIX® (NH TherAguix) nanoparticle has been developed to enhance radiotherapy treatment and provide strong MR contrast. These two properties have previously been investigated separately and progressed to clinical trial following a clinical workflow of separate MR imaging followed some time later by radiotherapy treatment. The recent development of MRI-linacs (combined Magnetic Resonance Imaging–linear accelerator systems enabling MRI-guided radiotherapy) opens up a new workflow where MR confirmation of nanoparticle uptake can be carried out at the time of treatment. A preclinical study was carried out to assess the suitability of a gadolinium-containing nanoparticle AGuIX® (NH TherAguix) for nano-enhanced image-guided radiotherapy on an MRI-linac.

Methods
Treatments were carried out on F344 Fischer rats bearing a 9L glioma brain tumour. Animals received either: (A) no treatment; (B) injection of nanoparticles followed by MRI; (C) radiotherapy with MRI; or (D) injection of nanoparticles followed by radiotherapy with MRI. Pre-clinical irradiations were carried out on the 1.0 T, 6 MV in-line Australian MRI-linac. Imaging used a custom head coil specially designed to minimise interference from the radiotherapy beam. Anaesthetised rats were not restrained during treatment but were monitored with a cine-MRI sequence. Inductively Coupled Plasma Mass Spectrometry (ICP-MS) analysis was used to quantify residual gadolinium in the brain in normal and tumour tissue.

Results
A preclinical evaluation of nano-enhanced radiation treatment has been carried out on a 1.0 T MRI-linac, establishing a workflow on these novel systems. Extension of life when combining radiotherapy with nanoparticles was not statistically different from that for rats receiving radiotherapy only. However, there was no detrimental effect for animals receiving nanoparticles and radiation treatment in the magnetic field compared with control branches. Cine-MR imaging was sufficient to carry out monitoring of anaesthetised animals during treatment. AGuIX nanoparticles demonstrated good positive contrast on the MRI-linac system allowing confirmation of tumour extent and nanoparticle uptake at the time of treatment.

Conclusions
Novel nano-enhanced radiotherapy with gadolinium-containing nanoparticles is ideally suited for implementation on an MRI-linac, allowing a workflow with time-of-treatment imaging. Live irradiations using this treatment workflow, carried out for the first time at the Australian MRI-linac, confirm the safety and feasibility of performing MRI-guided radiotherapy with AGuIX® nanoparticles. Follow-up studies are needed to demonstrate on an MRI-linac the radiation enhancement effects previously shown with conventional radiotherapy.
HbA1c variability and long-term glycemic control are linked to peripheral neuropathy in patients with type 1 diabetes
Authors: Pinto M. V. , Rosa L. C. G. F. , Pinto L. F. , Dantas J. R. , Salles G. F. , Zajdenverg L. , Rodacki M. , Lima M. A. 
Published: October 2020

Abstract
Background
HbA1c variability has been linked to retinopathy, renal disease and autonomic neuropathy in patients with type 1 diabetes mellitus (T1D) and type 2 diabetes mellitus (T2D). Although the same relationship has been demonstrated for diabetic peripheral neuropathy (DPN) in patients with T2D, data for T1D are still lacking.

Methods
Patients older than 17 years of age with ≥ 10 years of T1D duration and follow-up were included. All patients underwent nerve conduction studies and neurological examination. Laboratorial data was retrospectively extracted from chart review. Mean HbA1c (mHbA1c) over 10 years was calculated, as well as HbA1c variability estimated by standard deviation (HbA1c-SD) and coefficient of variation (HbA1c-CV).

Results
Fifty patients with T1D were included (30 females and 21 non-caucasians), with mean age and T1D duration of 25.6 ± 5.0 and 17.9 ± 6.1 years, respectively. The frequency of DPN was 24%. Higher mHbA1c (10.4 ± % vs 8.1 ± %; p < 0.001), HbA1c-SD (1.8 ± 0.8 vs 0.9 ± 0.4; p < 0.001), and HbA1c-CV (1.7 ± 0.8 vs 1.2 ± 1.1; p = 0.006) were observed in patients with DPN compared to others. SD-HbA1c and HbA1c-CV were associated with DPN, diagnosed by either clinical or NCS criteria, independent of mHbA1c, age and gender.

Conclusions
Not only long-term glycemic control, but also its variability is associated with DPN in patients with T1D. Larger studies are required to confirm this finding.
Human platelet lysate as a potential clinical-translatable supplement to support the neurotrophic properties of human adipose-derived stem cells
Authors: Palombella Silvia , Guiotto Martino , Higgins Gillian C. , Applegate Laurent L. , Raffoul Wassim , Cherubino Mario , Hart Andrew , Riehle Mathis O. , di Summa Pietro G. 
Published: October 2020

AbstractBackgroundThe autologous nerve graft, despite its donor site morbidity and unpredictable functional recovery, continues to be the gold standard in peripheral nerve repair. Rodent research studies have shown promising results with cell transplantation of human adipose-derived stem cells (hADSC) in a bioengineered conduit, as an alternative strategy for nerve regeneration. To achieve meaningful clinical translation, cell therapy must comply with biosafety. Cell extraction and expansion methods that use animal-derived products, including enzymatic adipose tissue dissociation and the use of fetal bovine serum (FBS) as a culture medium supplement, have the potential for transmission of zoonotic infectious and immunogenicity. Human-platelet-lysate (hPL) serum has been used in recent years in human cell expansion, showing reliability in clinical applications.MethodsWe investigated whether hADSC can be routinely isolated and cultured in a completely xenogeneic-free way (using hPL culture medium supplement and avoiding collagenase digestion) without altering their physiology and stem properties. Outcomes in terms of stem marker expression (CD105, CD90, CD73) and the osteocyte/adipocyte differentiation capacity were compared with classical collagenase digestion and FBS-supplemented hADSC expansion.ResultsWe found no significant differences between the two examined extraction and culture protocols in terms of cluster differentiation (CD) marker expression and stem cell plasticity, while hADSC in hPL showed a significantly higher proliferation rate when compared with the usual FBS-added medium. Considering the important key growth factors (particularly brain-derived growth factor (BDNF)) present in hPL, we investigated a possible neurogenic commitment of hADSC when cultured with hPL. Interestingly, hADSC cultured in hPL showed a statistically higher secretion of neurotrophic factors BDNF, glial cell-derived growth factor (GDNF), and nerve-derived growth factor (NFG) than FBS-cultured cells. When cocultured in the presence of primary neurons, hADSC which had been grown under hPL supplementation, showed significantly enhanced neurotrophic properties.ConclusionsThe hPL-supplement medium could improve cell proliferation and neurotropism while maintaining stable cell properties, showing effectiveness in clinical translation and significant potential in peripheral nerve research.
Raising Well at Home: a pre-post feasibility study of a lifestyle intervention for caregivers and their child with obesity
Authors: Haire-Joshu Debra , Schwarz Cindy , Jacob Rebekah , Kristen Pat , Johnston Shelly , Quinn Karyn , Tabak Rachel 
Published: October 2020

Abstract
Background
Few efficacious pediatric obesity interventions have been successfully translated and sustained in real-world practice, often due to inadequate fit with the priorities of under-resourced populations. Lifestyle interventions, which incorporate tailoring of essential weight loss ingredients and adaptation of mode and intensity to the living circumstances of children with obesity, are needed. The purpose of this pilot study was to test the feasibility and efficacy of a tailored lifestyle intervention for caregivers and their children with obesity, conducted in partnership with Envolve, Inc., a family of comprehensive health solutions and wholly owned subsidiary of Centene Corporation.

Methods
This 6-month pilot study employed a pretest-posttest design to assess the impact of a tailored lifestyle intervention delivered by peer coaches on (a) caregiver and child weight impacted by changes in dietary intake, walking, and screen time; (b) changes in the home environment; and (c) caregiver engagement and satisfaction. The intervention was delivered via 3 core home visits every 4–6 weeks, with additional support via text.

Results
The majority of caregivers were female (95.2%) and Black (73.7%). Children had median age of 11.1 years and majority were female (57.6%), with a median BMI near the 99th percentile (Mdn 98.8, IQR 3.5) or 118.3% (IQR 35.8) of the 95th percentile for their sex and age. Participants expressed high satisfaction with the program (mean range 96.7–100.0% agreement on satisfaction items). From baseline to post, caregivers’ BMI decreased by 1.8% (p = 0.016, r = 0.22), while children’s BMI percentile z-score decreased significantly (p = 0.023, r = 0.18) and BMI percent of the 95th percentile remained constant (p = 0.05, r = 0.15). Caregivers and children decreased sugar-sweetened beverage intake (p = 0.026, r = 0.22; p = 0.006, r = 0.23, respectively), reduced presence of soda in the home (p = 0.002, g = 0.43), and decreased screen time (p = 0.046, g = 0.22). Other eating and walking behaviors remained stable for caregivers and child.

Conclusion
The Raising Well at Home pilot demonstrated that tailored lifestyle interventions, delivered by peer coaches in the home and via text, are feasible and can improve weight, eating, and environmental measures of caregivers and children with obesity. Future work should determine the effectiveness, sustainability, and scalability of this intervention in sites located across the country.

Trial registration
ClinicalTrials.gov (NCT04224623). Registered 9 January 2020—retrospectively registered.
An explorative approach to the cross-section of international migration and sexual preference: same-sex couples in Germany
Authors: Braack Mirko K. , Milewski Nadja 
Published: October 2020

AbstractWe study the intersection of international migration and sexual preference from a socio-demographic perspective by looking at same-sex couples among migrants in Germany. Despite increasing ethnic diversity and greater social and legal liberality toward non-normative living arrangements, there are hardly any available quantitative data on this vulnerable group, which crosses two social boundaries. Drawing on the scientific-use file of the German Microcensus (2013), we estimate the prevalence of same-sex couples among female and male migrants, and describe their socio-demographic characteristics. We use different approaches to imputing data to account for the possibility that the reported information on same-sex relationships may be missing or wrong, and consider different definitions of “migrant status”. Our results show that the share of couples who were same-sex was smaller among the immigrant (0.2 to 1.4%) than among the native population (0.6 to 2.0%). Moreover, migrants in a same-sex couple were more similar in terms of other socio-demographic variables (age, education) to natives in a same-sex union than to migrants in an opposite-sex union. This study contributes to the LGBT social science literature by providing the first quantitative description of this minority-in-a minority group in Germany.
Field evaluation of horticultural mineral oils and botanicals against bean thrips, Megalurothrips distalis (Karny) (Thysanoptera: Thripidae), in summer mung bean
Authors: Singh Harkamalpreet , Cheema Harpreet Kaur , Singh Ravinder 
Published: October 2020

Abstract
Background
Bean thrips, Megalurothrips distalis (Karny), are a serious insect pest of mung bean grown in summer season as a catch crop in wheat–rice cropping system in North West India. Severe incidence leads to flower shedding and fewer pods leading to loss in grain yield. Field studies were conducted to evaluate the efficacy of horticultural mineral oils, neem-based botanicals, and pongamia soap in the form of spray in comparison to the insecticide dimethoate in 2018 and 2019.

Main body
Randomized complete block design (RCBD) was used with 11 treatments including untreated control in 3 replications. Neem seed kernel extract (NSKE) at 5% gave the highest mean percent reduction in the number of thrips (90.44 and 79.59%), followed by 10 ml l−1 of Neem Kavach 1500 ppm (85.55 and 78.97%) and the insecticide dimethoate 30% EC at 250 ml ha−1 (84.92 and 78.22%) 1 and 3 days after treatment. Neem Baan 1500 ppm, Indo-Neem 1500 ppm, and Nimbecidine 300 ppm each at 10 ml l−1 also provided 75.29–82.42% and 61.18–75.82% reduction 1 and 3 days after treatment. Horticultural mineral oils also reduced the insect population by about 64%, while pongamia soap was least effective (31.58%) among botanicals. Dimethoate 30% EC at 250 ml ha−1 recorded the highest grain yield and net returns, followed by NSKE, Nimbecidine, and Neem Kavach that were on par with it. Homemade neem extracts evaluated in 2019 caused 62.7–77.3% reduction in thrips population up to 3 days after treatment with yields comparable to 10 ml l–1 of Indo-Neem spray.

Conclusion
The study indicated that neem extract was capable to manage the bean thrips in flowers of summer mung bean and obtained a high grain yield.
Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users: a quasi-experimental study in Germany
Authors: Manthey Jakob , Kalke Jens , Rehm Jürgen , Rosenkranz Moritz , Verthein Uwe 
Published: October 2020

Background:New approaches are required to slow down or reverse increasing trends of levels of delta-9-tetrahydrocannabinol (THC) and cannabis-attributable hospitalizations in Germany. Legal access to cannabis may constitute one viable effective policy response; however, available evidence does not suffice to inform a regulation model for Germany. The proposed study aims to reduce harm for cannabis users through legal access to herbal cannabis through pharmacies.Protocol:A quasi-experimental study comparing cannabis users with legal access to herbal cannabis (Berlin, intervention group) to those without legal access (Hamburg, control group) (total N=698). As the primary outcome, we hypothesize that: 1) illegal THC consumption will reduce by at least 50% in the intervention group and 2) total THC exposure in the intervention group will be reduced by at least 10% lower than that of the control group, taking into account baseline values. Secondary outcomes comprise measures of frequency of use, THC-impaired driving, and mode of administration. Paired t-tests and multilevel regression models will be performed for statistical analyses.Discussion:This study proposal is currently being reviewed by the ‘Federal Institute for Drugs and Medical Devices’ – the body responsible for approving research studies on classified substances, including cannabis. Upon approval and prior to the start of the study, a full ethical review will be undertaken. Results may inform a regulation model for Germany and other jurisdictions and are expected to deepen the understanding of the effects of legal access to cannabis.Pre-registration:German Clinical Trials Register (DRKS), DRKS00020829