bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)
Authors: Lara Gongora Aline B. , Werutsky Gustavo , Jardim Denis L. , Nogueira-Rodrigues Angelica , Barrios Carlos H. , Mathias Clarissa , Maluf Fernando , Riechelmann Rachel , Fraga Maurício , Gomes Henry , William William N. , Yamada Camilla A. F. , de Castro Jr Gilberto , Rosa Daniela D. , de Melo Andreia C. , Sala Raul , Bustamante Eva , Bretel Denisse , Arrieta Oscar , Cardona Andrés F. , Bastos Diogo A. 
Published: May 2021

PURPOSE COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments. METHODS This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group. RESULTS There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine. CONCLUSION To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period.
Vitamin D3 Dose Requirement That Raises 25-Hydroxyvitamin D to Desirable Level in Overweight and Obese Elderly
Authors: Bacha Dania S , Rahme Maya , Al-Shaar Laila , Baddoura Rafic , Halaby Georges , Singh Ravinder J , Mahfoud Ziyad R , Habib Robert , Arabi Asma , El-Hajj Fuleihan Ghada 
Published: May 2021

Abstract

Context
Guidelines for the dosage of vitamin D supplementation vary widely globally.

Objective
To investigate the impact of 2 vitamin D doses, bracketed between the IOM recommended dietary allowance (RDA) and the upper tolerable limit, on vitamin D nutritional status in elderly individuals.

Methods
This post hoc analysis of data collected from a 12-month, double-blind, randomized control trial included 221 ambulatory participants (≥ 65 years) with a mean BMI of 30.2 kg/m2 and a mean baseline serum 25-hydroxyvitamin D [25(OH)D] level of 20.4 ± 7.4 ng/mL, who were recruited from 3 outpatient centers in Lebanon. All participants received 1000 mg of elemental calcium daily from calcium citrate plus the daily equivalent of either 600 IU or 3750 IU of vitamin D3.

Results
Mean 25(OH)D level at 12 months was 26.0 ng/mL with low dose and 36.0 ng/mL with high dose vitamin D3. The proportion of participants reaching a value ≥ 20 ng/mL was 86% in the low dose, and 99% in the high dose arms, with no gender differences. The increment of 25(OH)D per 100 IU/day was 1 ng/mL with the low dose, and 0.41 ng/mL with the high dose. Serum 25(OH)D levels at 1 year were highly variable in both treatment arms. Baseline 25(OH)D level and vitamin D dose—but not age, BMI, gender, or season—were significant predictors of serum 25(OH)D level post-intervention.

Conclusion
The IOM Recommended Dietary Allowance (RDA) of 600 IU/day does not bring 97.5% of ambulatory elderly individuals above the desirable threshold of 20 ng/mL. Country-specific RDAs are best derived taking into account the observed variability and predictors of achieved 25(OH)D levels.
Effects of Growth Hormone Treatment on Sleep-Related Parameters in Adults With Prader-Willi Syndrome
Authors: Shukur Hasanain Hamid , Hussain-Alkhateeb Laith , Farholt Stense , Nørregaard Ole , Jørgensen Anders Palmstrøm , Hoybye Charlotte 
Published: May 2021

Abstract

Context
Prader-Willi syndrome (PWS) is a rare, genetic, multisymptom, neurodevelopmental disease due to lack of the expression of the paternal genes in the q11 to q13 region of chromosome 15. The main characteristics of PWS are muscular hypotonia, hyperphagia, obesity, behavioral problems, cognitive disabilities, and endocrine deficiencies, including growth hormone (GH) deficiency. Sleep apnea and abnormal sleep patterns are common in PWS. GH treatment might theoretically have a negative impact on respiration.

Objective
Here we present the effect of GH treatment on polysomnographic measurements.

Methods
Thirty-seven adults, 15 men and 22 women, with confirmed PWS were randomly assigned to 1 year of GH treatment (n = 19) or placebo (n = 18) followed by 2 years of GH treatment to all. Polysomnographic measurements were performed every 6 months. A mixed-effect regression model was used for comparison over time in the subgroup that received GH for 3 years.

Results
At baseline median age was 29.5 years, body mass index 27.1, insulin-like growth factor 115 µg/L, apnea-hypopnea index (AHI) 1.4 (range, 0.0-13.9), and sleep efficiency (SE) 89.0% (range, 41.0%-99.0%). No differences in sleep or respiratory parameters were seen between GH- and placebo-treated patients. SE continuously improved throughout the study, also after adjustment for BMI, and the length of the longest apnea increased. AHI inconsistently increased within normal range.

Conclusion
SE improved during GH treatment and no clinical, significantly negative impact on respiration was seen. The etiology of breathing disorders is multifactorial and awareness of them should always be present in adults with PWS with or without GH treatment.
Additional Insulin Is Required in Both the Early and Late Postprandial Periods for Meals High in Protein and Fat: A Randomized Trial
Authors: Keating Barbara , Smart Carmel E M , Harray Amelia J , Paramalingam Nirubasini , Smith Grant , Jones Timothy W , King Bruce R , Davis Elizabeth A 
Published: May 2021

AbstractContextThe pattern and quantity of insulin required for high-protein high-fat (HPHF) meals is not well understood.ObjectiveThis study aimed to determine the amount and delivery pattern of insulin required to maintain euglycemia for 5 hours after consuming a HPHF meal compared with a low-protein low-fat (LPLF) meal.MethodsThis randomized crossover clinical trial, conducted at 2 Australian pediatric diabetes centers, included 10 patients (12-21 years of age) with type 1 diabetes for ≥ 1 year. Participants were randomized to HPHF meal (60 g protein, 40 g fat) or LPLF meal (5 g protein, 5 g fat) with identical carbohydrate content (30 g). A modified insulin clamp technique was used to determine insulin requirements to maintain postprandial euglycemia for 5 hours. Total mean insulin requirements over 5 hours were measured.ResultsThe total mean insulin requirements for the HPHF meal were significantly greater than for the LPLF meal (11.0 [CI 9.2, 12.8] units vs 5.7 [CI 3.8, 7.5] units; P = 0.001). Extra intravenous insulin was required for HPHF: 0 to 2 hours (extra 1.2 [CI 0.6, 1.6] units/h), 2 to 4 hours (extra 1.1 [CI 0.6, 1.6] units/h), and 4 to 5 hours (extra 0.6 [CI 0.1, 1.1] units/h) after the meal. There were marked inter-individual differences in the quantity of additional insulin (0.3 to 5 times more for HPHF) and the pattern of insulin delivery (0%-85% of additional insulin required in the first 2 hours).ConclusionThe addition of protein and fat to a standardized carbohydrate meal almost doubled the mean insulin requirement, with most participants requiring half of the additional insulin in the first 2 hours.
Case Report: A five-year follow up after pediatric renal transplantation using flow cytometry crossmatch and HLA immunophenotyping based on DNA for screening test
Authors: Dwi Meiyanto Johanes , Daryanto Besut , Penta Seputra Kurnia 
Published: May 2021

Background: There are three methods for renal replacement therapy for end stage chronic kidney disease; dialysis, continuous ambulatory peritoneal dialysis, and renal transplantation which is the best because of the least morbidity rate, the best survival rates, the best quality of life, and the best improvement in activities of daily living. In the field, flow cytometry serves a well-established role in pre- and post-transplant crossmatching, and if it is combined with human leukocyte antigen (HLA) immunophenotyping based on DNA, it will produce a more sensitive prediction of the chronic graft rejection compared to complement-dependent cytotoxicity crossmatching and can eliminate irrelevant antibody (IgM). This is the first experience using this method in our hospital. The survival rate at one, five and ten years has been shown to be 99%, 97% and 96%, respectively; therefore, we wanted to find out the five year follow up of the patient. Case presentation: We evaluated a 20-year-old female with a history of pediatric renal transplantation five years previously due to end stage renal disease caused by bilateral parenchymatous renal disease. She had a history of hypertension since December 2014 and underwent hemodialysis for three months. The transplantation took place in March 2015. A kidney from her mother was transplanted to recipient using end-to-side anastomoses. After five years, the patient was routinely monitored at the urology clinic, with creatinine serum results between 1.5 and 2 mg/dL, urea and electrolyte serum levels within normal limits and she could resume normal life. Conclusions: Survival five years after the procedure showed a beneficial outcome of the method used.
Care-seeking patterns amongst suspected paediatric pneumonia deaths in rural Malawi
Authors: King Carina , Banda Masford , Bar-Zeev Naor , Beard James , French Neil , Makwenda Charles , McCollum Eric D , Mdala Malizani , Bin Nisar Yasir , Phiri Tambosi , Ahmad Qazi Shamim , Colbourn Tim 
Published: May 2021

Background: Pneumonia remains a leading cause of paediatric deaths. To understand contextual challenges in care pathways, we explored patterns in care-seeking amongst children who died of pneumonia in Malawi. Methods: We conducted a mixed-methods analysis of verbal autopsies (VA) amongst deaths in children aged 1-59 months from 10/2011 to 06/2016 in Mchinji district, Malawi. Suspected pneumonia deaths were defined as: 1. caregiver reported cough and fast breathing in the 2-weeks prior to death; or, 2. the caregiver specifically stated the child died of pneumonia; or 3. cause of death assigned as ‘acute respiratory infection’ using InterVA-4. Data were extracted from free-text narratives based on domains in the ‘Pathways to Survival’ framework, and described using proportions. Qualitative analysis used a framework approach, with pre-specified themes. Results: We analysed 171 suspected pneumonia deaths. In total, 86% of children were taken to a healthcare facility during their final illness episode, and 44% sought care more than once. Of children who went to hospital (n=119), 70% were admitted, and 25% received oxygen. Half of the children died within a healthcare setting (43% hospital, 5% health centre and 2% private clinics), 64 (37%) at home, and 22 (13%) in transit. Challenges in delayed care, transport and quality of care (including oxygen), were reported. Conclusions: Healthcare was frequently sought for children who died of suspected pneumonia, however several missed opportunities for care were seen. Sustained investment in timely appropriate care seeking, quick transportation to hospital and improved case management at all levels of the system is needed.
Subjective wellbeing in people living with dementia: exploring processes of multiple object handling sessions in a museum setting
Authors: Camic Paul M. , Dickens Laura , Zeilig Hannah , Strohmaier Sarah 
Published: May 2021

Background: Dementia care guidance highlights the importance of supporting people living with dementia to access engaging and meaningful activities to promote their quality of life. There is a growing evidence base for the efficacy of heritage settings and arts-based interventions to provide social prescribing opportunities to help support wellbeing in this population. This study extended previous research and explored the potential processes underlying this effect in multiple small group object handling sessions in a museum setting. Methods: A mixed-methods design was used comprising a measure of subjective wellbeing and thematic analysis to explore in-the-moment session content across multiple sessions. Four people with dementia participated in three, one-hour group object handling sessions led by two facilitators. Results: Pre-post wellbeing scores showed increases after each session though this was largely not significant. Qualitative findings provided more compelling results, however, and identified four key themes: facilitating, interest in exploring objects, active participation, and group collaboration; interpretations were made around the dynamic interaction of themes and subthemes over the course of three sessions. Conclusions: This is the first study we are aware of that has taken an in-depth look at multiple museum-based group object handling sessions for people living with dementia. Findings offer ways to optimise object handling sessions for people with dementia by providing in-depth information about the processes involved across multiple object handling sessions facilitated by museum/heritage professionals in a museum setting. This has useful implications for community-based activities as part of dementia care planning and public health programming. The study contributes to a deeper understanding and elucidates the processes that enhance wellbeing for this population who participate in such sessions. It also helps to develop further theoretical understanding about why these types of activities are helpful in community-based dementia care. Limitations and implications for future research are discussed.
Prescriptive Analytics for Flexible Capacity Management
Authors: Notz Pascal M. , Pibernik Richard 
Published: May 2021

Motivated by the real-world problem of a logistics company, this paper proposes a novel distribution-free prescriptive analytics approach—termed kernelized empirical risk minimization (kernelized ERM)—to solve a complex two-stage capacity planning problem with multivariate demand and vector-valued capacity decisions and compares this approach both theoretically and numerically with an extension of the well-known sample average approximation (SAA) approach termed weighted SAA. Both approaches use integrated machine learning algorithms to prescribe capacities directly from historical demand and numerous features (covariates) without having to make assumptions about the underlying multivariate demand distribution. We provide extensive analytical insights into both approaches. Most important, we prove the universal approximation property for the kernelized ERM approach when using a universal (data-independent) kernel and show how out-of-sample guarantees can be derived for various kernels. We demonstrate the applicability of both approaches to a real-world planning problem and evaluate their performance relative to traditional parametric approaches that first estimate a multivariate demand distribution and then solve a stochastic optimization problem and a nonparametric approach (SAA). Our results suggest that the two prescriptive analytics approaches can result in substantial performance improvements of up to 58% compared with traditional approaches. Additional numerical analyses shed light on the behavior and performance drivers of the various approaches and demonstrate that in our case, the prescriptive approaches are much more robust to variations of exogenous cost parameters than traditional approaches. This paper was accepted by J. George Shanthikumar, Management Science Special Section on Data-Driven Prescriptive Analytics.
30-Day postoperative COVID-19 outcomes in 398 patients from regional hospitals utilising a designated COVID-19 minimal surgical site pathway
Authors: Chong SMY , Hung RKY , Gwozdz A , Irwin S , Eastbury J , Cross T , Ahmed K , Taylor C , Goldenberg SD , Sanderson J , Olsburgh J 
Published: May 2021

Introduction Postoperative pulmonary complications and mortality rates during the COVID-19 pandemic have been higher than expected, leading to mass cancellation of elective operating in the UK. To minimise this, the Guy’s and St Thomas’ Hospital NHS Foundation Trust elective surgery hub and the executive team at London Bridge Hospital (LBH) created an elective operating framework at LBH, a COVID-19 minimal site, in which patients self-isolated for two weeks and proceeded with surgery only following a negative preoperative SARS-CoV-2 polymerase chain reaction swab. The aim was to determine the rates of rates of postoperative COVID-19 infection. Methods The collaboration involved three large hospital trusts, covering the geographic area of south-east London. All patients were referred to LBH for elective surgery. Patients were followed up by telephone interview at four weeks postoperatively. Results Three hundred and ninety-eight patients from 13 surgical specialties were included in the analysis. The median age was 60 (IQR 29–71) years. Sixty-three per cent (252/398) were female. In total, 78.4% of patients had an American Society of Anesthesiologists grade of 1–2 and the average BMI was 27.2 (IQR 23.7–31.8) kg/m2. Some 83.6% (336/402) were ‘major’ operations. The rate of COVID-19-related death in our cohort was 0.25% (1/398). Overall, there was a 1.26% (5/398) 30-day postoperative all-cause mortality rate. Seven patients (1.76%) reported COVID-19 symptoms, but none attended the emergency department or were readmitted to hospital as a result. Conclusion The risk of contracting COVID-19 in our elective operating framework was very low. We demonstrate that high-volume major surgery is safe, even at the peak of the pandemic, if patients are screened appropriately preoperatively.
Optical switch with ultra high extinction ratio using electrically controlled metal diffusion
Authors: Singh Lalit , Srivastava Sulabh , Rajput Swati , Kaushik Vishal , Mishra Rahul Dev , Kumar Mukesh 
Published: May 2021

An optical switch with ultra high extinction ratio is proposed. Optical switching is realized using the resistive switching effect through the lateral coupling between the input nanophotonic waveguide and output waveguide at a wavelength of 1550 nm. The coupled waveguide system is engineered to increase the number of mode beats in a unit length of the device. An increase in the number of mode beats and controlled diffusion of metal ions through a thin dielectric layer with an applied electric field is responsible for a high optical extinction ratio of 27 dB for a 20 µm long device. Compared to electrical control by plasma dispersion in silicon, the resistive switching effect enables a reduction in the coupling length and an increase in the waveguide absorption, leading to an almost 100 times higher extinction ratio. The proposed compact on-chip silicon-based nanophotonic resistive device is a potential candidate for a large-scale integrated photonic circuit for applications in optical switching, modulation, memory, and computation.
A phase 1 clinical trial of SP16, a first-in-class anti-inflammatory LRP1 agonist, in healthy volunteers
Authors: Wohlford George F. , Buckley Leo F. , Kadariya Dinesh , Park Taeshik , Chiabrando Juan Guido , Carbone Salvatore , Mihalick Virginia , Halquist Matthew S. , Pearcy Adam , Austin Dana , Gelber Cohava , Abbate Antonio , Van Tassell Benjamin 
Published: May 2021

Background
Endogenous serine protease inhibitors are associated with anti-inflammatory and pro-survival signaling mediated via Low-density lipoprotein receptor-related protein 1 (LRP1) signaling. SP16 is a short polypeptide that mimics the LRP1 binding portion of alpha-1 antitrypsin.

Methods
A pilot phase I, first-in-man, randomized, double blind, placebo-controlled safety study was conducted to evaluate a subcutaneous injection at three dose levels of SP16 (0.0125, 0.05, and 0.2 mg/kg [up to 12 mg]) or matching placebo in 3:1 ratio in healthy individuals. Safety monitoring included vital signs, laboratory examinations (including hematology, coagulation, platelet function, chemistry, myocardial toxicity) and electrocardiography (to measure effect on PR, QRS, and QTc).

Results
Treatment with SP16 was not associated with treatment related serious adverse events. SP16 was associated with mild-moderate pain at the time of injection that was significantly higher than placebo on a 0–10 pain scale (6.0+/-1.4 [0.2 mg/kg] versus 1.5+/-2.1 [placebo], P = 0.0088). No differences in vital signs, laboratory examinations and electrocardiography were found in those treated with SP16 versus placebo.

Conclusion
A one-time treatment with SP16 for doses up to 0.2 mg/kg or 12 mg was safe in healthy volunteers.
Challenges experienced by patients with hypertension in Ghana: A qualitative inquiry
Authors: Atibila Fidelis , Ten Hoor Gill , Donkoh Emmanuel Timmy , Kok Gerjo 
Published: May 2021

Background
Hypertension (HPT) is an essential public health problem affecting both lower and middle-income countries disproportionately. Evidence suggests that HPT is the leading risk factor for cardiovascular diseases and chronic kidney disease. Yet, challenges faced by patients with HPT in Ghana are not sufficiently explored. This study, documents the challenges patients with HPT face in Ghana.

Methods
We used an explorative descriptive qualitative design. Face-to-face in-depth interviews were conducted with 15 patients with HPT. Interviews were recorded and transcribed verbatim. A thematic content analysis procedure was followed to analyse the data.

Results
Four main themes emerged from interviews; three of which pertained to dimensions of challenges and a fourth which pertained to coping strategies. These include: [1] impairment in physical activities and mobility constraints [2]. Psychological challenges such as suicidal ideations, sadness, fear, anxiety, and reduced sexual affection [3]. Socio-economic challenges identified include loss of friends and social network, difficulty in job demands, and financial burden, and [4] coping strategies such as health system support, social support, and religiosity were identified.

Conclusion
Patients with HPT experience an array of challenges. We suggest that health care facilities incorporate post HPT diagnosis counseling sessions for HPT patients in the study area. Also, the National Health Insurance Authority (NHIA) should re-examine their scope of services; thus, drugs, laboratory services, and electrocardiogram services to avoid the issue of co-payment. Collaboration between healthcare professionals and family relations of patients with HPT ought to also be strengthened to ensure optimal care.