bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effectiveness and safety of light vegetarian diet on functional constipation with gastrointestinal damp-heat pattern
Authors: Liu Yu , Gao Xudong , Ding Yuehua , Zhou Yuanchen , Liu Xinyuan , Wang Huijing , Wang Qianqian , Ma Bingzhi , Yao Shukun 
Published: December 2019

Abstract

Introduction:
Functional constipation (FC) is one of the common gastrointestinal disorders that affects people of almost every age. Persistent FC significantly affects quality of life and well-being along with economic burden on patients as well as health care system. Therapeutic efficacy of currently used treatment strategies becomes limited shortly after their discontinuation as constipation occurs again as a result of inappropriate dietary habits. Previous studies have revealed that light vegetarian diet (LVD) can significantly improve both typical and atypical subtypes of major traditional Chinese medicine (TCM) FC syndrome such as gastrointestinal damp-heat syndrome. This protocol aims at exploratorily investigating effectiveness and safety of LVD following a rigorous clinical trial.

Methods and design:
Total 92 patients in each of the 2 subtypes will be recruited in China-Japan Friendship Hospital for participating in this prospective, placebo-controlled, randomized trial and exploratory study. The patients in each subtype will be randomly divided into 4 groups according to 1:1:1:1 ratio with allocation concealment, which are drug + diet group, drug group, placebo + diet group and placebo group. Patients in the group with diet intervention will be required to strictly follow the LVD. The study will continue for a period of 28 days, including a drug or placebo supervised intervention and a 14th-day telephone follow-up. During the intervention, patients will be required to record a designed diary for controlling the diet quality (DQ) and analyzing the defecation. The study will focus investigation of complete spontaneous bowel movements (CSBM) per week as its primary outcome and constipation-related symptom rating scale (CSS), TCM syndrome scale (TCMSS), 48-hour gastrointestinal transit time (48-hour GITT), high resolution anorectal manometry (HRAM) and fecal flora detection (FFD) will be included in secondary outcomes. Furthermore, the study will also determine safety, DQ and compliance indicators.

Ethics and dissemination:
This study has been approved by China-Japan Friendship Hospital clinical research ethics committee (No. 2017–46–1). A SPIRIT checklist is available for this protocol.

Trial registration number:
ChiCTR1800019686 in Chinese Clinical Trial Registry (WHO ICTRP member).
Efficacy and safety of Shenmayizhi decoction as an adjuvant treatment for vascular dementia
Authors: Wang Huichan , Liu Nanyang , Wei Yun , Pei Hui , Liu Meixia , Diao XueMei , Zhang Huiqin , Li Hao 
Published: December 2019

Abstract

Background:
Vascular dementia (VaD) is the second most common cause of dementia. The treatment of VaD still remains a challenge so far. Traditional Chinese Herbal medicine is a promising therapy due to their multiple components and targets. Shenmayizhi decoction (SMYZD), a Chinese Herbal prescription, has been reported its effective in alleviating cognitive dysfunction in clinical practice. However, strong clinical research of SMYZD in the treatment of VaD was lack. Therefore, we design this study to evaluate the adjuvant role of SMYZD in the treatment of VaD.

Methods:
This is a multicenter, randomized, blind, controlled trial. A total of 196 eligible patients will be assigned to receive Ginkgo biloba extracts (GBEs) plus SMYZD granule or GBEs plus SMYZD mimetic granule in a 1:1 ratio. The duration of the trial will be 12 weeks, and a follow-up will be performed at the 24th week. The primary outcomes are the National Institute of Health stroke scale (NIHSS) and the Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcomes include the Mini-Mental State Examination (MMSE), the traditional Chinese Medicine (TCM) syndrome scale, Activities of Daily Living (ADL), concentrations of hypersensitive C-reactive protein (Hs-CRP), neuron-specific enolase (NSE) and homocysteine (HCY) in serum. Researchers will record any adverse events throughout the trial.

Discussion:
This study will provide evidences to evaluate the efficacy and safety of SMYZD in combination with GBEs in treatment of VaD, as well as the adjuvant role of SMYZD in combination.

Trial is registered at Chinese Clinical Trial Registry:
ChiCTR1800017359.
Dangguijagyag-san for primary dysmenorrhea
Authors: Seo Jihye , Lee Donghun , Jo Hee-Geun 
Published: December 2019

Abstract

Background:
Primary dysmenorrhea is the most common gynecological disorder in women of reproductive age. In East Asia, traditional herbal medicines have been used for a long time to treat symptoms of primary dysmenorrhea. Dangguijagyag-san (DJS) is one of the most widely known traditional herbal medicine for primary dysmenorrhea. Although there was the previous systematic review of DJS, it had some limitations. To assess the effectiveness of DJS for primary dysmenorrhea and to update the previous review, this protocol was developed to conduct a systematic review and meta-analysis.

Methods:
We will search the randomized controlled clinical trials of DJS for primary dysmenorrhea from inception to April 2019. The search database will be PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Oriental Medicine Advanced Searching Integrated System, Korean Traditional Knowledge Portal, Korean Medical Database, National Digital Science Library, and the China National Knowledge Infrastructure. Our 2 authors will perform the selection of studies, the extraction of data, and the quality assessment with risk of bias tool independently. To analyze the data, we will conduct the quantitative synthesis.

Results:
We will synthesize the data from selected studies and estimate the strength of the evidence DJS for the treatment of primary dysmenorrhea.

Conclusion:
This study will provide the scientific evidence of DJS.

Systematic review registration:
PROSPERO registration number is CRD42019130768.
Corneal decompensation due to spontaneous absorption of lens and anterior dislocation of lens capsule
Authors: Wu Shuangqing , Yu Xiaoyu , Dai Qi , Fu Yana , Lin Xiaolei 
Published: December 2019

Abstract

Rationale:
Spontaneous absorption of lenses or cataracts is rare. However, lens capsule attachment to the endothelium combined with corneal decompensation can still occur.

Patient concerns:
An 81-year-old male presented with left eye pain and bulbar conjunctival injection for 6 months. Diffuse corneal edema and inferior bullous lesions were observed by slit-lamp microscopy. Following examination with swept-source optical coherence tomography, we could clearly identify a membrane structure adherent to the corneal endothelium, as well as a lens not in situ. In vivo confocal microscopy found decreased corneal endothelial density of 745 ± 46 cells per mm2 in the left eye.

Diagnosis:
Lens dislocation and spontaneous absorption, combined with corneal decompensation were diagnosed.

Interventions:
Surgical removal of the membrane structure combined with anterior vitrectomy was performed.

Outcomes:
The patient's symptoms were partly relieved. However, the corneal endothelial decompensation could not be entirely reversed. In vivo confocal microscopy verified that corneal endothelium was in situ and the density was not significantly changed in the left eye.

Lessons:
This case study reports a rare dislocation and spontaneous absorption of lens without any trauma or subsequent surgery. Moreover, it demonstrates corneal endothelial decompensation due to the lens capsule adhering to the corneal endothelium. Timely intervention is required to remove the dislocated lens and prevent complications.
Evaluating Race and Ethnicity Reported in Hospital Discharge Data and Its Impact on the Assessment of Health Disparities
Authors: Howland Renata E. , Tsao Tsu-Yu 
Published: December 2019

Background:
Improving the collection and quality of race and ethnicity reported in hospital data is a key step in identifying disparities in health service utilization and outcomes and opportunities for quality improvement.

Objective:
The objective of this study was to assess the quality of race/ethnicity reported in hospital discharge data and examine the impact on the identification of disparities in select health outcomes in New York City.

Research Design:
Using the birth certificate as a gold standard, we examined the quality of hospital discharge race/ethnicity and estimated the impact of misclassification on racial/ethnic disparities in severe maternal morbidity and preventable hospitalizations.

Subjects:
Delivery hospitalizations from the New York State hospital discharge data (Statewide Planning and Research Cooperative System) linked with 2015 New York City birth certificates.

Measures:
Sensitivity and positive predictive value (PPV).

Results:
The non-Hispanic white and black race had relatively high sensitivity and PPV. Hispanic ethnicity and Asian race had moderate sensitivity and high PPV, but were often misclassified as “Other.” As a result, health disparities may be underestimated for those of Hispanic ethnicity and Asian race, particularly for indicators that use population denominators drawn from another source.

Conclusions:
The quality of hospital discharge data varies by race/ethnicity and may underestimate disparities in some groups. Future research should validate findings with other data sources, identify driving factors, and evaluate progress over time.
Risk of Frequent Emergency Department Use Among an Ambulatory Care Sensitive Condition Population
Authors: Hudon Catherine , Courteau Josiane , Chiu Yohann M. , Chouinard Maud-Christine , Dubois Marie-France , Dubuc Nicole , Elazhary Nicolas , Racine-Hemmings Francois , Dufour Isabelle , Vanasse Alain 
Published: December 2019

Background:
A small fraction of patients use a disproportionately large amount of emergency department (ED) resources. Identifying these patients, especially those with ambulatory care sensitive conditions (ACSC), would allow health care professionals to enhance their outpatient care.

Objective:
The objectives of the study were to determine predictive factors associated with frequent ED use in a Quebec adult population with ACSCs and to compare several models predicting the risk of becoming an ED frequent user following an ED visit.

Research Design:
This was an observational population-based cohort study extracted from Quebec’s administrative data.

Subjects:
The cohort included 451,775 adult patients, living in nonremote areas, with an ED visit between January 2012 and December 2013 (index visit), and previously diagnosed with an ACSC but not dementia.

Measures:
The outcome was frequent ED use (≥4 visits) during the year following the index visit. Predictors included sociodemographics, physical and mental comorbidities, and prior use of health services. We developed several logistic models (with different sets of predictors) on a derivation cohort (2012 cohort) and tested them on a validation cohort (2013 cohort).

Results:
Frequent ED users represented 5% of the cohort and accounted for 36% of all ED visits. A simple 2-variable prediction model incorporating history of hospitalization and number of previous ED use accurately predicted future frequent ED use. The full model with all sets of predictors performed only slightly better than the simple model (area under the receiver-operating characteristic curve: 0.786 vs. 0.759, respectively; similar positive predictive value and number needed to evaluate curves).

Conclusions:
The ability to identify frequent ED users based only on previous ED and hospitalization use provides an opportunity to rapidly target this population for appropriate interventions.
Pharmaceutical Preconditioning With Nitric Oxide Synthase and l-Arginine in Ischemic Tissues
Authors: Gazyakan Emre , Hirche Christoph , Reichenberger Matthias A. , Germann Günter , Engel Holger 
Published: December 2019

Background
Nitric oxide (NO) is a multifunctional signaling molecule involved in regulating vascular tone and tissue oxygenation. It is also an important cytoprotective agent against ischemia-reperfusion injury (IRI). Enhancing NO bioavailability via exogenous NO synthases (NOSs) and l-arginine promotes conversation to NO, circumventing the problem of nonfunctioning NOSs under hypoxic and acidic conditions. In this study, the authors evaluated the therapeutic efficacy of neuronal, inducible, and endothelial NOS and l-arginine on reperfusion-induced skin flap alterations.

Methods
The vascular pedicle isolated rat skin flap model was used and underwent 3 hours of ischemia. At 30 minutes before ischemia, normal saline, endothelial-, inducible-, and neuronal NOSs (1/2 IU) and l-arginine (100 mg/kg body weight) were administered by means of intravenous infusion. The IRI-induced alterations were measured 5 days after the operation.

Results
The 3 isoforms of NOS increased the flap vitality rate (VR) from 10% to 23% compared with the control group. l-Arginine treatment also increased the VR by approximately 15%. The combination of l-arginine with NOS resulted in even higher flap VRs. The best results could be achieved with the combination of endothelial NOS (2 IU) and l-arginine.

Conclusions
Modulation of NO bioavailability via exogenous application of NOSs and l-arginine significantly improved VRs in a skin flap rat model. This pharmacologic preconditioning has the potential to attenuate IRI-induced alterations in skin flaps.
Predictive Value of Endoscopic Features for a Complete Response After Chemoradiotherapy for Rectal Cancer
Authors: van der Sande Marit E. , Maas Monique , Melenhorst Jarno , Breukink Stéphanie O. , van Leerdam Monique E. , Beets Geerard L. 
Published: December 2019

Objective and Background:
Watch-and-wait approach in rectal cancer relies on the identification of a clinical complete response (CR) after neoadjuvant (chemo)radiotherapy. This is mainly performed by rectal examination, magnetic resonance imaging, and endoscopy. Endoscopy has been less well studied, and the objective of the study is to assess the diagnostic value of endoscopy and the predictive value of endoscopic features for the identification of CR.

Patients and Methods:
A total of 161 patients with primary rectal cancer undergoing flexible sigmoidoscopy for response assessment after neoadjuvant (chemo)radiotherapy between January 2012 and December 2015 at a single institution were evaluated retrospectively. Three independent readers scored endoscopic features and a confidence level score for a CR. Diagnostic performance of endoscopy and positive predictive value (PPV) of endoscopic features for a CR were calculated. If available, biopsy results were revealed to the reader and a change in confidence level was noted. Reference standard was histology after surgery, or long-term outcome in a watch-and-wait policy.

Results:
Median time to endoscopy was 9 (interquartile range 8–12) weeks. Area under the receiver operator characteristic curve, sensitivity, specificity, PPV, and negative predictive value for a CR were 0.80 to 0.84, 72% to 94%, 61% to 85%, 63% to 78% and 80% to 89%, respectively. A flat scar was the most predictive feature of a CR (PPV 70%–80%). The PPV of small flat ulcers and large flat ulcers were 40% to 50% and 29% to 33%, respectively. The addition of biopsy results led to a significant change in confidence level score in 4% to 13% of patients.

Conclusions:
More than 70% of the patients with a luminal CR after neoadjuvant treatment for rectal cancer can be identified by endoscopy at ±9 weeks. Together with findings on digital rectal examination (DRE) and magnetic resonance imaging, specific endoscopic features can be used to select patients for an extended observation period to select for organ preservation.
Patient Views on Surgeon-specific Outcome Reporting in Vascular Surgery
Authors: John Imogen J. , Choo Huay , Pettengell Christopher J. , Riga Celia V. , Martin Guy F. J. , Bicknell Colin D. 
Published: December 2019

Background:
SSMD are used to enhance transparency, improve quality and facilitate patient choice. The use of SSMD is controversial, but patients’ views on such data are largely unknown.

Objectives:
The aim of this study was therefore to explore the views of patients and to identify their priorities for outcome reporting in vascular surgery.

Methods:
A prospective questionnaire study of 165 patients receiving care in a single academic vascular unit was performed. Data on patients’ current understanding and use of SSMD, together with future priorities were collected.

Results:
Of the 165 patients 80% were unaware of SSMD. 72% thought they should be made aware of the data, although 63% thought they were likely to misinterpret the results. The majority recognized the utility of SSMD to inform treatment (60%) and surgeon (53%) choice. The majority prioritize the patient-surgeon relationship (90%) and past experiences of care (71%) when making treatment decisions. A significant majority (66% vs 49%; P < 0.005) would favour hospital-level to surgeon-level data. The main patient priorities for future outcome reporting were waiting list length (56%), the quality of hospital facilities (55%), and patient satisfaction (54%).

Conclusions:
The aims of SSMD reporting are not currently being met, and both patients and healthcare professionals have shared concerns over the nature and usefulness of the data. Patients express a preference for hospital-level outcomes and prioritize the experience of receiving care over outcomes when making treatment decisions. Future outcome reporting should include patient-directed hospital-level metrics that are readily accessible and understood by all.
Preoperative Statin Use and 90-Day Mortality After Noncardiac Surgery
Authors: Im Chami , Oh Tak Kyu , Song In-Ae , Jeon Young-Tae 
Published: December 2019

Objective:
The aim of this study was to investigate the association between preadmission statin use and 90-day mortality after planned elective noncardiac surgery in adult patients.

Summary Background Data:
Statin therapy is known to have pleiotropic effects, which improve the outcomes of various diseases. However, the effect of perioperative statin therapy on postoperative mortality remains controversial.

Methods:
This retrospective cohort study analyzed the medical records of adult patients who were admitted to a single tertiary academic hospital for elective noncardiac surgery between January 2012 and December 2018. The primary endpoint was 90-day mortality, which was defined as any mortality within 90 days after surgery. The secondary endpoint was overall survival.

Results:
After propensity score matching, a total of 33,514 patients (16,757 patients in each group) were included in the analysis. The logistic regression analysis of the propensity score-matched cohort indicated that the odds ratio (OR) of 90-day mortality in the statin group was 26% lower than that of the nonstatin group [OR: 0.74; 95% confidence interval (CI): 0.59 to 0.92; P = 0.009]. The sensitivity analysis indicated that the high-dose intensity statin group had a 61% lower 90-day mortality rate than the nonstatin group (OR: 0.39; 95% CI: 0.18–0.84; P = 0.016). The overall survival time was significantly longer in the statin group than in the nonstatin group after propensity score matching (P < 0.001 by log-rank test).

Conclusions:
Preoperative statin use was associated with lower 90-day mortality and longer overall survival for adult patients who underwent elective noncardiac surgery. This association was more evident for high-intensity statin users.
The Prevalence and Significance of Jejunal and Duodenal Bulb Polyposis After Duodenectomy in Familial Adenomatous Polyposis
Authors: Yoon Ji Yoon , Mehta Neal , Burke Carol A. , Augustin Toms , O’Malley Margaret , LaGuardia Lisa , Cruise Michael , Mankaney Gautam , Church James , Kalady Matthew , Walsh R. Matthew , Bhatt Amit 
Published: December 2019

Objective:
To evaluate the prevalence, natural history, and severity of polyposis of the duodenal bulb and jejunum after duodenectomy in patients with FAP.

Summary of Background Data:
Advanced duodenal polyposis stage in FAP requires consideration of duodenal resection to prevent cancer; pylorus-preserving approach of pancreas-sparing duodenectomy (PSD) is preferred. Post-duodenectomy data indicate polyps occur in the duodenal bulb and the post-anastomotic jejunum, but limited data exists regarding their significance.

Methods:
We identified consecutive FAP patients After duodenal resection, including pancreaticoduodenectomy, PSD, or segmental duodenectomy, at Cleveland Clinic. Medical records were used to determine time to diagnosis of duodenal bulb or jejunal polyps, length of follow up, and severity of polyposis including maximal Spigelman stage (SS) of jejunal polyposis (neo-SS).

Results:
64 patients with FAP underwent duodenectomy and endoscopic follow up. 28% underwent pancreaticoduodenectomy, 61% PSD, and 11% segmental duodenectomy. Postoperatively, 38/64 (59%) were diagnosed with jejunal polyposis, with median time to diagnosis of 55 months and follow up time of 127 months. Jejunal polyposis was advanced in 21% (neo- SS III or IV). Fifty percent were treated endoscopically, 1 patient required surgery. Jejunal polyp-free survival after duodenectomy differed by surgery type (P = 0.008). A total of 55/64 patients underwent a pylorus-preserving procedure, and 6/55 (11%) developed duodenal bulb polyps. All bulb polyps were large (>20 mm) and found after PSD. Endoscopic resection was unsuccessful in 5 patients, but no surgical intervention was required.

Conclusions:
Polyposis occurs in the remaining duodenal and jejunal mucosa in the majority of patients after surgical duodenectomy. Jejunal polyposis is advanced in 1 in 5 patients, but rarely requires surgery. Endoscopic management of jejunal polyposis seems feasible but has proven difficult for duodenal bulb polyps.
Oncological Outcome After Diagnostic Biopsies in Gastrointestinal Stromal Tumors
Authors: van Houdt Winan J. , IJzerman Nikki S. , Schrijver Anne Marjolein , Huis in ‘t Veld Eva , Thway Khin , Jones Robin L. , Fotiadis Nicos , Hayes Andrew J. , Bruining Annemarie , Zavrakidis Ioannis , van Coevorden Frits , Steeghs Neeltje , Mathijssen Ron H. J. , Strauss Dirk C. , Smith Myles J. F. 
Published: December 2019

Objective:
To analyze whether the route of preoperative biopsy influences oncological outcome in GIST patients.

Summary of Background Data:
Preoperative biopsies are widely used for diagnosing GIST. Little is known about the risk of tumor seeding after different routes of biopsy.

Methods:
Patients who underwent resection of a primary GIST between 1996 and 2014 were identified from 2 databases from 2 tertiary referral centers. Survival data were obtained using the Kaplan-Meier method. Possible confounders were identified using Cox regression analysis. The primary endpoint was local recurrence free survival (RFS) and the secondary endpoint was DSS.

Results:
A total of 228 patients were included, with a median age of 62 years (range 17–86) and a median follow-up time of 53 months (range 1–204). From these patients, 42 patients did not have a biopsy (18%), 70 underwent a transcutaneous biopsy (31%), and 116 a transluminal biopsy (51%). A total of 42 patients (19.0%) had a local and/or distant recurrence. From the 70 patients with a transcutaneous biopsy, only 1 patient developed a needle tract recurrence (1.4%). Local RFS and DSS were both significantly shorter in the transcutaneous biopsy group on univariate analysis compared to the other groups; however, in multivariate analysis the route of biopsy did not influence local RFS (P = 0.128) or DSS (P = 0.096).

Conclusions:
Transluminal or transcutaneous biopsies for diagnosing GIST do not significantly alter the risk of local recurrent disease or DSS in multivariate Cox regressions. The risk of needle tract seeding after transcutaneous biopsy was low.