bluuebunny/crossref_metadata_2025_split huggingface dataset:
The HIV care cascade for adolescents initiated on antiretroviral therapy in a health district of South Africa: a retrospective cohort study
Authors: Haghighat Roxanna , Toska Elona , Bungane Nontuthuzelo , Cluver Lucie 
Published: January 2021

Abstract
Background
Little evidence exists to comprehensively estimate adolescent viral suppression after initiation on antiretroviral therapy in sub-Saharan Africa. This study examines adolescent progression along the HIV care cascade to viral suppression for adolescents initiated on antiretroviral therapy in South Africa.

Methods
All adolescents ever initiated on antiretroviral therapy (n=1080) by 2015 in a health district of the Eastern Cape, South Africa, were interviewed in 2014–2015. Clinical records were extracted from 52 healthcare facilities through January 2018 (including records in multiple facilities). Mortality and loss to follow-up rates were corrected for transfers. Predictors of progression through the HIV care cascade were tested using sequential multivariable logistic regressions. Predicted probabilities for the effects of significant predictors were estimated by sex and mode of infection.

Results
Corrected mortality and loss to follow-up rates were 3.3 and 16.9%, respectively. Among adolescents with clinical records, 92.3% had ≥1 viral load, but only 51.1% of viral loads were from the past 12 months. Adolescents on ART for ≥2 years (AOR 3.42 [95%CI 2.14–5.47], p< 0.001) and who experienced decentralised care (AOR 1.39 [95%CI 1.06–1.83], p=0.018) were more likely to have a recent viral load. The average effect of decentralised care on recent viral load was greater for female (AOR 2.39 [95%CI 1.29–4.43], p=0.006) and sexually infected adolescents (AOR 3.48 [95%CI 1.04–11.65], p=0.043). Of the total cohort, 47.5% were recorded as fully virally suppressed at most recent test. Only 23.2% were recorded as fully virally suppressed within the past 12 months. Younger adolescents (AOR 1.39 [95%CI 1.06–1.82], p=0.017) and those on ART for ≥2 years (AOR 1.70 [95%CI 1.12–2.58], p=0.013) were more likely to be fully viral suppressed.

Conclusions
Viral load recording and viral suppression rates remain low for ART-initiated adolescents in South Africa. Improved outcomes for this population require stronger engagement in care and viral load monitoring.
Demographic features of identified PLWHA infected through commercial and nonmarital noncommercial heterosexual contact in China from 2015 to 2018: a retrospective cross-sectional study
Authors: Dong Zhilong , Ma Liying , Cai Chang , Gao George Fu , Lyu Fan 
Published: January 2021

Abstract
Background
Understanding the demographic characteristics of people living with HIV/AIDS (PLWHA) infected through commercial heterosexual contact (CHC) or nonmarital noncommercial heterosexual contact (NMNCHC) is important for HIV/AIDS prevention and control.

Methods
Cases reported through the Chinese HIV/AIDS Case Reporting System (CRS) from 2015 to 2018 were analyzed. A descriptive and preliminary inferential analysis were performed for those demographic characteristics deemed of interest.

Results
Overall, 523,121 identified PLWHA between 2015 and 2018 in the CRS were analyzed. The constituent ratio of heterosexual transmission increased from 66.25% in 2015 to 71.48% in 2018. The proportion of CHC heterosexual transmission decreased from 40.18% in 2015 to 37.99% in 2018, while that of NMNCHC increased from 46.33% in 2015 to 49.02% in 2018. PLWHA infected through NMNCHC were significantly younger than those who were infected through CHC (Student’s t test, P < 0.0001), with an average age gap ranging from 5.63 (2015) to 7.46 (2018) years, and the average age of both groups increased annually. The frequency of newly identified PLWHA who were infected through CHC had a remarkable increase among the ages of 65 and above. Gender distribution was significantly different between CHC and NMNCHC (χ2 = 8909.00(2015), 9941.90(2016), 11,004.00 (2017), 12,836.00(2018), all P < 0.0001), and the ratio of men to women in the NMCHC group was 1.50:1 (2015), 1.51:1 (2016), 1.54:1 (2017), and 1.52:1 (2018), while in the commercial heterosexual contact (CHC) group, these ratios were 11.45:1 (2015), 12.08:1 (2016), 12.53:1 (2017), and 13.28:1 (2018). Marital status was significantly different between CHC and NMNCHC (χ2 = 94.67 (2015), 109.88(2016), 58.18(2017), 152.38(2018), all P < 0.0001). As the educational level improved, the proportion of NMNCHC also increased (Cochran - Armitage test, P < 0.0001).

Conclusions
We found that heterosexual transmission was the primary mode of HIV transmission in China from 2015 to 2018. PLWHA infected through CHC and NMNCHC had different characteristics in age, gender, marital status, and educational level. The frequency of PLWHA infected through CHC increased substantially in the age group of 65 and above. This study provides useful baseline data for future studies on the heterosexual transmission of HIV in China.
Clinical physiological parameters for the prediction of gram-negative bacterial infection in the emergency department
Authors: Hsu Chan-Peng , Chen Hsin-Yu , Chen Wei-Lung , Chen Jiann-Hwa , Huang Chien-Cheng , Wu Po-Han , Chung Jui-Yuan 
Published: January 2021

AbstractBackgroundEarly detection and treatment of Gram-negative bacteria (GNB), major causative pathogens of sepsis (a potentially fatal condition caused by the body’s response to an infection), may benefit a patient’s outcome, since the mortality rate increases by 5–10% for each hour of delayed therapy. Unfortunately, GNB diagnosis is based on bacterial culture, which is time consuming. Therefore, an economic and effective GNB (defined as a positive blood, sputum, or urine culture) infection detection tool in the emergency department (ED) is warranted.MethodsWe conducted a retrospective cohort study in the ED of a university-affiliated medical center between January 01, 2014 and December 31, 2017. The inclusion criteria were as follows: (1) age ≥ 18; (2) clinical suspicion of bacterial infection; (3) bacterial culture from blood, sputum, or urine ordered and obtained in the ED. Descriptive statistics was performed on patient demographic characteristics, vital signs, laboratory data, infection sites, cultured microorganisms, and clinical outcomes. The accuracy of vital signs to predict GNB infection was identified via univariate logistic regression and receiver operating characteristic (ROC) curve analysis.ResultsA total of 797 patients were included in this study; the mean age was 71.8 years and 51.3% were male. The odds ratios of patients with body temperature ≥ 38.5 °C, heart rate ≥ 110 beats per minute, respiratory rate ≥ 20 breaths per minute, and Glasgow coma scale (GCS) < 14, in predicting GNB infection were found to be 2.3, 1.4, 1.9, and 1.6, respectively. The area under the curve values for ROC analysis of these measures were 0.70, 0.68, 0.69, and 0.67, respectively.ConclusionThe four physiological parameters were rapid and reliable independent predictors for detection of GNB infection.
The physician as a success determining factor in CT-guided pain therapy
Authors: Stueckle Christoph A. , Hackert Benedikt , Talarczyk Sarah , Wawro Martin , Haage Patrick , Weger Ulrich 
Published: January 2021

AbstractBackgroundBack pain is a common problem and a burden for the patient. MR-morphologically proven pain-causing changes of the spine is often successfully treated utilizing CT-guided pain therapy. The CT-guided execution enables a controlled and reproducible therapy. Nevertheless, treatment results can differ even with the same patient; the physician is a possible influencing factor of the outcome. Accordingly, the present study analyzes the different behaviors and forms of communication of the treating physicians during the course of the intervention as factors influencing the outcome of treatment.Methods67 patients suffering from specific back pain were included in this study. 5 treating physicians (2 female, 3 male) of different age (29–63 years), and experience and a total of 244 CT-guided treatments were included in this study. In every case a psychologist observed the treatment based on a standardized observation protocol. Observed were both the verbal and non-verbal interactions as well as the reaction of patient and physician. The success of the therapy was measured in the course of the treatment using the visual analogue pain scale. The technical comparability of the performed CT-guided periradicular therapy was ensured by the distribution of the drug mixture.ResultsThe outcome is significantly better if the patient considers the treating physician to be competent (correlation coefficient: 0.24,p < 0.006) and feels understood (correlation coefficient: 0.29,p < 0.001). In addition, the outcome is better when the physician believes that the treatment brings a positive reduction of pain, underlining his belief with positive statements of affirmation before the intervention thus creating a positive atmosphere [correlation coefficient: 0.24 (p < 0.009)]. In contrast, the outcome is worse if the patient complains about pain during the intervention [average pain reduction M = 0.9 (pain group) vs. M = 2.0 (no-pain group)].ConclusionOur study shows that with comparable implementation of CT-guided periradicular therapy, the outcome of the patient with specific back pain can be significantly improved by certain behavioral patterns of the performing physician and this without side effects and without significant additional time expenditure. Our findings indicate that there is a non-negligible psychological factor linking confidence in therapy to actual therapy success.Trial Registration: The study was designed as an observational study, therefore a trial registration was not necessary.
A qualitative study of women and partners from Lebanon and Quebec regarding an expanded scope of noninvasive prenatal testing
Authors: Haidar Hazar , Le Clerc-Blain Jessica , Vanstone Meredith , Laberge Anne-Marie , Bibeau Gilles , Ghulmiyyah Labib , Ravitsky Vardit 
Published: January 2021

AbstractBackgroundIn the near future, developments in non-invasive prenatal testing (NIPT) may offer couples the opportunity to expand the range of genetic conditions tested with this technology. This possibility raises a host of ethical and social concerns, such as the type of information (medical vs. non-medical information) that couples might be exposed to and how this might complicate their informed decision-making. Currently, only limited research, mainly carried out in western countries, was conducted on women’s and partners’ views regarding the potential expansion of NIPT.MethodsThis study used semi-structured interviews with pregnant women and their partners to explore their views on future potential NIPT applications such as non-medical sex selection and non-medical traits, paternity testing, and NIPT use for fetal whole genome sequencing (FWGS). It was conducted in Lebanon and Quebec, as case studies to explore the impact of cultural differences on these views.ResultsWe found no differences and many similarities when comparing the perceptions of participants in both contexts. While couples in both settings disapproved of the use of NIPT for non-medical sex selection and non-medical traits such as physical characteristics, they were near-unanimous about their support for its use for paternity testing in specific cases, such as legal doubts or conflicts related to the identity of the father. Participants were more ambivalent about NIPT for Fetal Whole Genome Sequencing. They supported this use to detect conditions that would express at birth or early childhood, while objecting to testing for adult-onset conditions.ConclusionsThese results can further inform the debate on the future uses of NIPT and future policy related its implementation.
Optimal biological dose: a systematic review in cancer phase I clinical trials
Authors: Fraisse J. , Dinart D. , Tosi D. , Bellera C. , Mollevi C. 
Published: January 2021

Abstract
Background
Classical phase 1 dose-finding designs based on a single toxicity endpoint to assess the maximum tolerated dose were initially developed in the context of cytotoxic drugs. With the emergence of molecular targeted agents and immunotherapies, the concept of optimal biological dose (OBD) was subsequently introduced to account for efficacy in addition to toxicity. The objective was therefore to provide an overview of published phase 1 cancer clinical trials relying on the concept of OBD.

Methods
We performed a systematic review through a computerized search of the MEDLINE database to identify early phase cancer clinical trials that relied on OBD. Relevant publications were selected based on a two-step process by two independent readers. Relevant information (phase, type of therapeutic agents, objectives, endpoints and dose-finding design) were collected.

Results
We retrieved 37 articles. OBD was clearly mentioned as a trial objective (primary or secondary) for 22 articles and was traditionally defined as the smallest dose maximizing an efficacy criterion such as biological target: biological response, immune cells count for immunotherapies, or biological cell count for targeted therapies. Most trials considered a binary toxicity endpoint defined in terms of the proportion of patients who experienced a dose-limiting toxicity. Only two articles relied on an adaptive dose escalation design.

Conclusions
In practice, OBD should be a primary objective for the assessment of the recommended phase 2 dose (RP2D) for a targeted therapy or immunotherapy phase I cancer trial. Dose escalation designs have to be adapted accordingly to account for both efficacy and toxicity.
Identifying response and predictive biomarkers for Transcranial magnetic stimulation outcomes: protocol and rationale for a mechanistic study of functional neuroimaging and behavioral biomarkers in veterans with Pharmacoresistant depression
Authors: Williams Leanne M. , Coman John T. , Stetz Patrick C. , Walker Nicole C. , Kozel F. Andrew , George Mark S. , Yoon Jong , Hack Laura M. , Madore Michelle R. , Lim Kelvin O. , Philip Noah S. , Holtzheimer Paul E. 
Published: January 2021

Abstract
Background
Although repetitive transcranial magnetic stimulation (‘TMS’) is becoming a gold standard treatment for pharmacoresistant depression, we lack neural target biomarkers for identifying who is most likely to respond to TMS and why. To address this gap in knowledge we evaluate neural targets defined by activation and functional connectivity of the dorsolateral prefrontal cortex-anchored cognitive control circuit, regions of the default mode network and attention circuit, and interactions with the subgenual anterior cingulate. We evaluate whether these targets and interactions between them change in a dose-dependent manner, whether changes in these neural targets correspond to changes in cognitive behavioral performance, and whether baseline and early change in neural target and cognitive behavioral performance predict subsequent symptom severity, suicidality, and quality of life outcomes. This study is designed as a pragmatic, mechanistic trial partnering with the National Clinical TMS Program of the Veteran’s Health Administration.

Methods
Target enrollment consists of 100 veterans with pharmacoresistant Major Depressive Disorder (MDD). All veterans will receive a clinical course of TMS and will be assessed at ‘baseline’ pre-TMS commencement, ‘first week’ after initiation of TMS (targeting five sessions) and ‘post-treatment’ at the completion of TMS (targeting 30 sessions). Veterans will be assessed using functional magnetic resonance imaging (fMRI), a cognitive behavioral performance battery, and established questionnaires. Multivariate linear mixed models will be used to assess whether neural targets change with TMS as a function of dose (Aim 1), whether extent and change of neural target relates to and predicts extent of behavioral performance (Aim 3), and whether extent of neural target change predicts improvement in symptom severity, suicidality, and quality of life (Aim 3). For all three aims, we will also assess the contribution of baseline moderators such as biological sex and age.

Discussion
To our knowledge, our study will be the first pragmatic, mechanistic observational trial to use fMRI imaging and cognitive-behavioral performance as biomarkers of TMS treatment response in pharmacoresistant MDD. The results of this trial will allow providers to select suitable candidates for TMS treatment and better predict treatment response by assessing circuit connectivity and cognitive-behavioral performance at baseline and during early treatment.

Trial registration
ClinicalTrials.gov NCT04663481, December 5th, 2020, retrospectively registered. The first veteran was enrolled October 30th, 2020.
Metacognitive training: a useful complement to community-based rehabilitation for schizophrenia patients in China
Authors: Chen Qi , Sang Yueyun , Ren Lifang , Wu Jinping , Chen Yajun , Zheng Menglei , Bian Guolin , Sun Hanying 
Published: January 2021

Abstract
Background
The traditional general practitioner-based model (community-based rehabilitation [CBR]) for Chinese schizophrenia patients lacks sufficient content, usefulness, and theoretical basis for rehabilitation. Based on previous research, we postulate that Metacognitive Training (MCT) is effective in the community for schizophrenic patients.

Method
A randomized controlled, assessor-blinded trial was conducted. A total of 124 schizophrenia patients were recruited from Ningbo China and were randomly assigned to an intervention or a control group. A general practitioner (GP) training plan was carried out before intervention. Intervention and control groups received two CBR follow-ups once a month, while the intervention group, received an additional eight once-a-in-week session of MCT. The Positive and Negative Syndrome Scale (PANSS), and the Psychotic Symptom Rating Scales (PSYRATS) were the primary outcome instruments, while the Quality of Life Scale (SQLS) was the secondary outcome instrument.

Results
In the post-treatment between-groups assessment, the patients in the intervention group showed significantly more reductions on PSYRATS delusions, PSYRATS total, PANSS P6, PANSS core delusions, PANSS positive, PANSS negative, PANSS general and PANSS total, and a significant improvement in SQLS psychosocial aspect.

Conclusions
The study provides preliminary evidence for the usefulness of MCT as a complementary measure for community-based rehabilitation of schizophrenia patients.

Trial registration
ISRCTN, ISRCTN17333276. Registered 09 August 2020 - Retrospectively registered.
A randomized controlled trial of long-acting muscarinic antagonist and long-acting β2 agonist fixed-dose combinations in patients with chronic obstructive pulmonary disease
Authors: Muraki Masato , Kunita Yuki , Shirahase Ken , Yamazaki Ryo , Hanada Soichiro , Sawaguchi Hirochiyo , Tohda Yuji 
Published: January 2021

Abstract
Background
In chronic obstructive pulmonary disease (COPD) patients, combination treatment with long-acting muscarinic antagonist (LAMA) and long-acting β2 agonist (LABA) increases forced expiratory volume in one second and reduces symptoms compared to monotherapy. In Japan, three different once-daily fixed-dose combinations (FDCs) have been prescribed since 2015, although a direct comparison of these FDCs has never been performed. The objective of the present study was to compare the effectiveness, preference, and safety of three LAMA/LABA FDCs—glycopyrronium/indacaterol (Gly/Ind), umeclidinium/vilanterol (Ume/Vil), and tiotropium/olodaterol (Tio/Olo)—in patients with COPD.

Methods
We enrolled 75 COPD outpatients (male:female ratio, 69:6; 77.4 ± 6.9 years). A prospective, randomized, crossover study was conducted on three groups using three FDCs: Gly/Ind; Ume/Vil; and Tio/Olo. Each medication was administered for 4 weeks before crossover (total 12 weeks). After each FDC administration, a respiratory function test and questionnaire survey were conducted. A comparative questionnaire survey of all three LAMA/LABA FDCs was conducted after 12 weeks (following administration of final FDC).

Results
No significant differences in COPD Assessment Test or modified Medical Research Council dyspnea questionnaire were reported in the surveys completed after each FDC administration; no significant differences in spirometric items were observed. In the final comparative questionnaire survey, patients reported better actual feeling of being able to inhale following Gly/Ind administration compared with Tio/Olo, although no significant differences in adverse events or other evaluations were reported.

Conclusions
The three LAMA/LABA FDCs administered to COPD patients show similar effects and safety, although some minor individual preference was reported.
Trial registration This study retrospectively registered with the University Hospital Medical Information Network Clinical Trials Registry (number UMIN000041342, registered on August 6, 2020).
Factors associated with failure of bony union after conservative treatment of acute cases of unilateral lumbar spondylolysis
Authors: Tatsumura Masaki , Gamada Hisanori , Okuwaki Shun , Eto Fumihiko , Nagashima Katsuya , Ogawa Takeshi , Mammoto Takeo , Hirano Atsushi , Koda Masao , Yamazaki Masashi 
Published: January 2021

Abstract
Background
If bone union is expected, conservative treatment is generally selected for lumbar spondylolysis. However, sometimes conservative treatments are unsuccessful. We sought to determine the factors associated with failure of bony union in acute unilateral lumbar spondylolysis with bone marrow edema including contralateral pseudarthrosis.

Methods
This study targeted unilateral lumbar spondylolysis treated conservatively in high school or younger students. Conservative therapy was continued until the bone marrow edema disappeared on MRI and bone union was investigated by CT. We conducted a univariate analysis of sex, age, pathological stage, lesion level complicating the contralateral bone defect, lesion level, and intercurrent spina bifida occulta, and variables with p < 0.1 were considered in a logistic regression analysis. An item with p < 0.05 was defined as a factor associated with failure of bony union.

Results
We found 92 cases of unilateral spondylolysis with bone marrow edema and 66 cases were successfully treated conservatively. Failure of bony union in unilateral lumbar spondylolysis with bone marrow edema was associated with progressive pathological stage (p = 0.004), contralateral pseudarthrosis (p < 0.001), and L5 lesion level (p = 0.002). The odds ratio was 20.0 (95% CI 3.0–193.9) for progressive pathological stage, 78.8 (95% CI 13–846) for contralateral pseudarthrosis, and 175 (95% CI 8.5–8192) for L5 lesion level.

Conclusions
Conservative therapy aiming at bony union is contraindicated in cases of acute unilateral spondylolysis when the pathological stage is progressive, the lesion level is L5, or there is contralateral pseudarthrotic spondylolysis.