bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical efficacy of Qi Di laxative decoction in the treatment of functional constipation
Authors: Wang Jian-Fang , Sun Zhong-Mei , Li Jun-Xiang 
Published: December 2020

Abstract

Background:
Functional constipation (FC) is a common gastrointestinal disorder characterized by slow bowel movement and defecation difficulties, significantly impacting patients’ quality of life and exerting heavy financial burden to whole society. However, more than 50% FC patients are not completely satisfied with current therapies and alternative therapies are urgently required. Increasing evidences have demonstrated that traditional Chinese medicine has a good therapeutic effect on FC, which is well known for its multitarget and multimode effects on diverse diseases as well as less side effects. Furthermore, studies proved that Qi Di Laxative Decoction was an effective treatment for FC. Its safety and effectiveness should be verified by further studies.

Methods:
We will search the following electronic databases for randomized controlled trials to evaluate the clinical efficacy of Qi Di Laxative Decoction in treating FC: Wanfang and Pubmed Database, China National Knowledge Infrastructure Database, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature, and Excerpta Medica database. Each database will be searched from inception to November 2020. The entire process will include study selection, data extraction, risk of bias assessment, and meta-analyses.

Results:
This proposed study will evaluate the clinical efficacy of Qi Di Laxative Decoction for patients with FC. The outcomes will include changes in FC relief and adverse effect.

Conclusion:
This proposed systematic review will evaluate the existing evidence on the clinical efficacy of Qi Di Laxative Decoction in treating FC.

Dissemination and ethics:
The results of this review will be disseminated through peer-reviewed publication. Because all of the data used in this systematic review and meta-analysis has been published, this review does not require ethical approval. Furthermore, all data will be analyzed anonymously during the review process.

OSF Registration Number:
DOI 10.17605/OSF.IO/M2ESR
The comparison of the effectiveness and safety of drospirone ethinyl estradiol and ethinyl estradiol cyproterone in the treatment of polycystic ovarian syndrome
Authors: Liu Zhimin , Song Ying , Xu Yuanfang , Wang Jing , Hu Hongyuan , Weng Yingchun 
Published: December 2020

Abstract

Background:
Polycystic ovarian syndrome (PCOS) is an endocrine disorder syndrome with reproductive dysfunction and abnormal glucose metabolism. Persistent non-ovulation, excessive androgens and insulin resistance are important features and they are the most common causes of menstrual disorders in women during childbearing years. At present, the cause of PCOS is not clinically clear. Current studies suggest that it may be due to the interaction of certain genetic genes with environmental factors. It is an important cause of infertility or early miscarriage with the characteristics of various causes and complex clinical manifestations. At present, for the treatment of PCOS patients, clinical treatment mainly includes hypoglycemia, insulin and menstrual regulation and other symptomatic and supportive treatment. Drospirone ethinyl estradiol and ethinyl estradiol cyproterone are 2 of the most commonly used drugs in clinical treatment of PCOS, but there is lack of the evidence of evidence-based medicine. Therefore, this study systematically evaluates the therapeutic effect and safety of PCOS patients with 2 short-acting oral contraceptives, drospirone ethinyl estradiol and ethinyl estradiol cyproterone, which provides the guidance for clinically selecting the appropriate drug to treat PCOS.

Methods:
Searching CNKI, WanFang Data, VIP, SinoMed, PubMed, EMbase, Web of Science, and The Cochrane Library database by computer, collecting the randomized controlled studies of DEE and EEC in the treatment of PCOS. The retrieval time limit is from the establishment of each database to July 1, 2020. In addition, tracing the references incorporated into the literature to supplement to the relevant literature. Using the retrieval method by combining the free words and the subject words, and the individual search of different databases is carried out. Meta-analysis is performed using RevMan 5.3 software after 2 researchers independently screens the literature, extracts the data, and evaluates the bias risk included in the study.

Results:
This study will systematically evaluate the DEE and EEC in the treatment of PCOS by collecting the required evidence to understand the effects of the 2 drugs on hypersotrophicemia, insulin resistance, lipid metabolism, and the safety during drug use in patients of this class, and the results will be published in highly influential academic journals.

Conclusion:
The results of this study will provide theoretical basis for the drug treatment of polycystic ovarian syndrome and provide help in the decision-making of clinical treatment of the disease.

Ethics and dissemination:
In this study, meta-analysis was used to conduct a second study on the published literature. Therefore, this type of systematic review research does not need to be approved by ethics.

OSF Registration DOI:
10.17605/OSF.IO/8GW9M.
Comparison between open reduction and internal fixation and minimally invasive surgery in management of Sanders type II calcaneal fracture
Authors: Xue Dingshan , Lou Baozhen , Tan Rongrong , Yu Hongchang 
Published: December 2020

Abstract

Background:
The minimally invasive surgery possesses an essential and growing function in treating the calcaneal fractures, but the related literature on this topic is limited. For our study, the main purpose was to compare the early prognosis of a group of the patients with Sanders type II fracture of calcaneus treated via minimally invasive surgery and open reduction and internal fixation (ORIF).

Methods:
This is a prospective randomized controlled trial in the patients who suffer from displaced intra-articular calcaneal fractures. This current study was carried out in accordance with the guidelines of “CONSORT statement” for the randomized controlled studies. All patients were randomly assigned into 2 groups on the basis of a random number table, namely the minimally invasive treatment group and the ORIF group using conventional methods. Inclusion criteria included the followings: aged between 18 to 59 years old; closed and unilateral fracture; patients with displaced intra-articular calcaneal fracture (>2 mm) involving Sanders Type IIC and Type IIB; and patients have enough mental capacity to understand and answer questions in the evaluation scale. In the process of outpatient follow-up, the radiographs were taken at 1, 3, 6, and 12 months. The functional results involved the American Orthopaedic Foot and Ankle Score, Foot Function Index, and the pain score.

Conclusions:
This protocol will give us research directions in future work.

Trial registration:
This study protocol was registered in Research Registry (researchregistry6261).
Response evaluation after immunotherapy in NSCLC
Authors: Park Sohyun , Lee Youngjoo , Kim Tae-Sung , Kim Seok-ki , Han Ji-Youn 
Published: December 2020

Abstract
The present study aimed to evaluate the role of early F-18 2-deoxy-2-[fluorine-18] fluoro-D-glucose positron emission tomography/computed tomography (FDG PET/CT) in non-small cell lung cancer patients undergoing immune checkpoint inhibitor (ICI) treatment.
Twenty-four non-small cell lung cancer patients who received nivolumab or pembrolizumab and underwent FDG PET/CT as an interim analysis after 2 or 3 cycles of ICI treatment were retrospectively enrolled. Tumor response was assessed using the PET Response Criteria in Solid Tumors 1.0 (PERCIST) and the European Organization for Research and Treatment of Cancer (EORTC) criteria after 2 or 3 cycles of ICI treatment (SCAN-1) and after an additional 2 cycles of ICI treatment (SCAN-2). The best overall response was determined by FDG PET/CT or chest CT at ≥ 3 months after therapy initiation, and the clinical benefit was investigated. progression-free survival was investigated, and its correlation with clinicopathologic and metabolic parameters was examined using a Cox multivariate proportional hazards model.
In the interim analysis, 4 patients achieved a complete metabolic response (CMR), 1 patient exhibited a partial metabolic response (PMR), and 14 patients had Progressive metabolic disease (PMD) according to the PERCIST and EORTC criteria. Four patients showed stable metabolic disease (SMD) according to the PERCIST criteria, and 2 patients showed different responses (i.e., PMR) according to the EORTC criteria. Patients with a CMR or PMR at SCAN-1 had a clinical benefit. Among the 4 patients with SMD at SCAN-1, only 1 experienced a clinical benefit regardless of the percent change in the peak standardized uptake value. Two patients with discordant response assessments between the PERCIST and EORTC criteria showed conflicting clinical benefits. Among the 14 patients with PMD, none experienced any clinical benefit. Only metabolic parameters were significant factors for predicting progression in the multivariate analysis (peak standardized uptake value and metabolic tumor volume, HRs of 1.18 and 1.00, respectively).
Based on early F-18 FDG PET/CT after ICI treatment, metabolic parameters could predict post-treatment progression. Responses after ICI treatment were correctly assessed in patients with a CMR, a PMR, and PMD, but patients with SMD required a meticulous follow-up because of varying clinical benefits.
Effectiveness comparisons of Chinese patent medicine on sciatica
Authors: An Hongqiang , Li Bing , Zhao Jifeng , Ao Zhijian , Zhong Xiaohui , Zhu Pengfei , Wu Jianlin 
Published: December 2020

Abstract

Background:
Sciatica is one of the common clinical diseases. Studies have proved the efficacy of Chinese patent medicine (CPM) in the treatment of sciatica, so far, there has not been a complete systematic review of its effectiveness and safety, and the comparative efficacy and safety of CPM have not been ranked. Therefore, it is necessary to evaluate the efficacy and safety of these CPM by means of systematic review and network meta-analysis (NMA), and to compare them in order.

Methods:
We will search PubMed, Cochrane Library, EMbase, Web of Science, CNKI, Wanfang, VIP, CBM and other databases for RCTs of CPM in the treatment of sciatica, (database established until December 30, 2020). In addition, we will manually search the “Pharmaceutical Information”, “National Essential Drug List”, “Chinese Pharmacopoeia”, etc. to inquire about drug instructions, and screen the market circulation and clinically commonly used CPM. We will use RevMan software, gemtc package, GeMTC software for statistical analysis, and draw the surface under cumulative ranking area (SUCRA) to predict the order of curative effect of treatment measures.

Results:
Our study will compare and evaluate the effectiveness of CPM in the treatment of sciatica, and rank different CPM. The outcome indicators will include clinical efficacy, pain degree, lumbar spine function and adverse events.

Conclusion:
Our research will provide support for clinical practice.

INPLASY registration number:
INPLASY2020110073.
Herbal medicine for cervicogenic dizziness
Authors: Oh Hyunjoo , Shin Seungwon , Lee Euiju 
Published: December 2020

Abstract

Background:
Herbal medicines are empirically used to treat cervicogenic dizziness. However, till date there have been no systematic review to evaluate the efficacy and safety of these medicines. Therefore, this study protocol describes the methods for evaluating the efficacy and safety of herbal medicine for cervicogenic dizziness.

Methods and analysis:
The following electronic academic databases will be searched up to December 2019 without language or publication status restrictions: Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), and the Cochrane Central Register of Controlled Trials (CENTRAL), together with Korean, Chinese, and Japanese databases. Any randomized controlled trials related to herbal medicine for cervicogenic dizziness will be included. The functional outcomes and the vertebrobasilar artery hemodynamic states will be evaluated as primary outcomes. The total effective rate, hematological conditions, and adverse events will be assessed as secondary outcomes. Study selection, data extraction, quality assessment of studies, and qualitative evaluation of clinical evidence will be performed by 2 independent reviewers. The methodological quality of the included studies will be evaluated using a revised Cochrane risk-of-bias tool for randomized trials. The strength of evidence from the included data will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Data synthesis will be performed as either a fixed-effects or a random-effects model using Review Manager software version 5.3. The results will be reported as a risk ratio for dichotomous outcomes and as a mean difference or standardized mean difference for continuous outcomes.

Ethics and dissemination:
No ethical approval is required since the individual clinical information of the patient is not used. The findings of this systematic review will be disseminated through the peer-reviewed publications or conference presentations.

Review Registry Unique Identifying Number:
reviewregistry1036.
Diagnosis of Schaaf-Yang syndrome in Korean children with developmental delay and hypotonia
Authors: Ahn Hyunji , Seo Go Hun , Oh Arum , Lee Yena , Keum Changwon , Heo Sun Hee , Kim Taeho , Choi Jeongmin , Kim Gu-Hwan , Ko Tae-Sung , Yum Mi-Sun , Lee Beom Hee , Choi In Hee 
Published: December 2020

Abstract
Schaaf-Yang syndrome (SYS) is a recently identified disorder caused by a loss-of-function mutation in a maternally imprinted gene, MAGEL2, at 15q11.2q13. Due to its extreme rarity and wide range of clinical severity, clinical suspicion is difficult for a physician. In the current study, its frequency among the Korean pediatric patients with developmental delay (DD) or intellectual disability (ID) was assessed. As the first report of Korean patients with SYS, our study aims to increase the awareness of this condition among the physicians taking care of the pediatric patients with DD/ID and hypotonia.
The patients diagnosed with SYS by whole-exome sequencing (WES) among the 460 Korean pediatric patients with DD/ID were included, and their clinical and molecular features were reviewed.
Four patients (0.9%) were diagnosed with SYS. Profound DD (4 patients), multiple anomalies including joint contractures and facial dysmorphism (4 patients), generalized hypotonia (3 patients), and severe respiratory difficulty requiring mechanical ventilation (3 patients) were noted in most cases, similar to those in previous reports. Sleep apnea (2 patients), autistic features (2 patients), a high grade of gastroesophageal reflux (1 patient), and seizures (1 patient) were found as well. A total of 3 different truncating MAGEL2 mutations were identified. A previously-reported mutation, to be the most common one, c.1996dupC, was found in 2 patients. The other 2 mutations, c.2217delC and c.3449_3450delTT were novel mutations. As MAGEL2 is maternally imprinted, 2 patients had inherited the MAGEL2 mutation from their respective healthy fathers.
SYS is an extremely rare cause of DD/ID. However, hypotonia, joint contractures, profound DD/ID and facial dysmorphism are the suggestive clinical features for SYS. As a maternally imprinted disorder, it should be reminded that SYS may be inherited in form of a mutation from a healthy father.
PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline
Authors: Tew William P. , Lacchetti Christina , Ellis Annie , Maxian Kathleen , Banerjee Susana , Bookman Michael , Jones Monica Brown , Lee Jung-Min , Lheureux Stéphanie , Liu Joyce F. , Moore Kathleen N. , Muller Carolyn , Rodriguez Patricia , Walsh Christine , Westin Shannon N. , Kohn Elise C. 
Published: December 2020

(Abstracted from J Clin Oncol 2020;38:3468–3493)
Despite advances in diagnosis and therapy, an individual with ovaries carries an approximate 1 in 108 lifetime chance to die due to ovarian cancer (OC). Primary therapy typically involves surgical cytoreduction and a combination regimen of platinum and a taxane.
Organ Donation Authorization After Brain Death Among Patients Admitted to PICUs in the United States, 2009–2018*
Authors: Spaulding Alicen B. , Zagel Alicia L. , Cutler Gretchen J. , Brown Angela , Zier Judith L. 
Published: December 2020

Objectives:
To identify trends in and factors associated with pediatric organ donation authorization after brain death.

Design:
Retrospective cohort study of data from Virtual Pediatric Systems, LLC (Los Angeles, CA).

Setting:
Data from 123 PICUs reporting to Virtual Pediatric Systems from 2009 to 2018.

Patients:
Patients less than 19 years old eligible for organ donation after brain death.

Measurements and Main Results:
Of 2,777 eligible patients, 1,935 (70%) were authorized for organ donation; the authorization rate remained unchanged over time (ptrend = 0.22). In a multivariable logistic regression model, hospitalizations lasting greater than 7 days had lower odds of authorization (adjusted odds ratio, 0.5; p < 0.001 vs ≤ 1 d) and White patients had higher odds than other race/ethnicity groups. Authorization was higher for trauma-related encounters (adjusted odds ratio, 1.5; p < 0.001) and when donation was discussed with an organ procurement organization coordinator (adjusted odds ratio, 1.7; p < 0.001). Of 123 hospitals, 35 (28%) met or exceeded a 75% organ donation authorization target threshold; these hospitals more often had an organ procurement organization coordinator discussing organ donation (85% vs 72% of encounters; p < 0.001), but no difference was observed by PICU bed size.

Conclusions:
Organ donation authorization after brain death among PICU patients was associated with length of stay, race/ethnicity, and trauma-related encounter, and authorization rates were higher when an organ procurement organization coordinator was involved in the donation discussion. This study identified factors that could inform initiatives to improve the authorization process and increase pediatric organ donation rates.
A rapid, high-sensitivity SARS-CoV-2 nucleocapsid immunoassay to aid diagnosis of acute COVID-19 at the point of care
Authors: Drain Paul K. , Ampajwala Madhavi , Chappel Christopher , Gvozden Andre B. , Hoppers Melanie , Wang Melody , Rosen Robert , Young Stephen , Zissman Edward , Montano Michalina 
Published: December 2020

AbstractBackgroundThe LumiraDx SARS-CoV-2 antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2, was evaluated for diagnosing acute COVID-19 in adults and children across point-of-care settings.MethodsTwo paired anterior nasal swabs or two paired nasopharyngeal swabs were collected from each participant. Swabs were tested by the LumiraDx SARS-CoV-2 antigen test and compared with real-time PCR (rt-PCR; Roche cobas 6800 platform). Positive- and negative predictive values and likelihood ratios were calculated. Results stratified based on gender, age, duration of symptoms, and rt-PCR cycle threshold.ResultsOut of the 512 participants, aged 0-90 years, of this prospective validation study, 414 (81%) were symptomatic for COVID-19 and 123 (24%) swabs were positive for SARS-CoV-2 based on rt-PCR testing. Compared with rt-PCR, the 12-minute swab test had 97.6% sensitivity and 96.6% specificity within 12 days of symptom onset, representing the period of infectivity. All (100%) samples detected within 33 rt-PCR cycles were also identified using the antigen test. Results were consistent across age and gender. Despite being performed by minimally trained healthcare workers, the user error rate of the test system was 1%.ConclusionThe rapid high-sensitivity assay using nasopharyngeal or anterior nasal sampling may offer significant improvements for diagnosing acute SARS-CoV-2 infection in clinic- and community-based settings.SummaryA 12-minute nasal swab test detects 97.6% of COVID-19 infections, compared to gold standard real-time PCR testing, up to 12 days following symptom onset using a microfluidic immunoassay for SARS-CoV-2 nucleocapsid protein.
Changes in cardiovascular disease monitoring in English primary care during the COVID-19 pandemic: an observational cohort study
Authors: Bankhead Clare R , Lay-Flurrie Sarah , Nicholson Brian D , Sheppard James P , Gale Chris P , Liyanage Harshana , McGagh Dylan , Minchin Mark , Perera Rafael , Sherlock Julian , Smith Margaret , Thomas Nicholas PB , Drakesmith Cynthia Wright , de Lusignan Simon , Hobbs FD Richard 
Published: December 2020

AbstractObjectiveTo quantify the impact and recovery in cardiovascular disease monitoring in primary care associated with the first COVID-19 lockdown.DesignRetrospective nationwide primary care cohort study, utilising data from 1st January 2018 to 27th September 2020.SettingWe extracted primary care electronic health records data from 514 primary care practices in England contributing to the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID). These practices were representative of English primary care across urban and non-urban practices.ParticipantsThe ORCHID database included 6,157,327 active patients during the study period, and 13,938,390 patient years of observation (final date of follow-up 27th September 2020). The mean (SD) age was 38±24 years, 49.4% were male and the majority were of white ethnicity (65% [21.9% had unknown ethnicity])ExposureThe primary exposure was the first national lockdown in the UK, starting on 23rd March 2020.Main outcome measuresRecords of cholesterol, blood pressure, HbA1c and International Normalised Ratio (INR) measurement derived from coded entries in the primary care electronic health record.ResultsRates of cholesterol, blood pressure, HbA1c and INR recording dropped by 23-87% in the week following the first UK national lockdown, compared with the previous week. The largest decline was seen in cholesterol (IRR 0.13, 95% CI 0.11 to 0.15) and smallest for INR (IRR 0.77, 95% CI 0.72 to 0.81).Following the immediate drop, rates of recorded tests increased on average by 5-9% per week until 27th September 2020. However, the number of recorded measures remained below that expected for the time of year, reaching 51.8% (95% CI 51.8 to 51.9%) for blood pressure, 63.7%, (95% CI 63.7% to 63.8%) for cholesterol measurement and 70.3% (95% CI 70.2% to 70.4%) for HbA1c. Rates of INR recording declined throughout the previous two years, a trend that continued after lockdown. There were no differences in the times series trends based on sex, age, ethnicity or deprivation.ConclusionsCardiovascular disease monitoring in English primary care declined substantially from the time of the first UK lockdown. Despite a consistent recovery in activity, there is still a substantial shortfall in the numbers of recorded measurements to those expected. Strategies are required to ensure cardiovascular disease monitoring is maintained during the COVID-19 pandemic.