bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomized, Placebo-Controlled Phase 1/2 Study to Determine the Appropriate ATX-101 Concentration for Reduction of Submental Fat
Authors: Goodman Greg J. , Spelman Lynda J. , Lowe Nicholas , Bowen Beta 
Published: June 2021

BACKGROUND
ATX-101 is indicated for submental fat treatment.

OBJECTIVE
Evaluate ATX-101 versus placebo for reducing submental fat.

MATERIALS AND METHODS
Adults with unwanted submental fat across 6 global sites were randomized to ATX-101 (0.5%, 1.0%, or 2.0%) or placebo for ≤4 treatments every 28 days. Outcomes included safety (adverse events and pain visual analog scale) throughout the study and efficacy (submental fat rating, patient satisfaction, and submental fat improvements) at Week 16.

RESULTS
Eighty-four of 85 enrolled patients received ≥1 ATX-101 treatment (0.5% [n = 20], 1.0% [n = 20], 2.0% [n = 22] or placebo [n = 22]). Most patients (n = 82) experienced adverse events, which were mostly mild/moderate, seemed to be dose-related, and led to no study discontinuations. The mean pain scores were highest in the ATX-101 1.0% and 2.0% groups. Week-16 change from baseline in the submental fat rating scale was significantly greater for ATX-101 0.5% and 1.0% versus placebo (p ≤ .05). At Week 16, 71%, 74%, 53%, and 40% of patients in the ATX-101 0.5%, 1.0%, 2.0%, and placebo groups, respectively, achieved a ≥1-grade reduction in submental fat from baseline. Satisfaction with appearance and patient-assessed global improvement ratings increased in all ATX-101 treatment groups versus placebo.

CONCLUSION
All ATX-101 concentrations were safe and efficacious for moderate/severe submental fat reduction.
Harmful Use of Alcohol as Predictor of Presex Drinking in Mexican Young College Women
Authors: Villegas-Pantoja Miguel A. , Mendez-Ruiz Martha D. , Sánchez-López Lucrecia , Herrera-Paredes José Manuel , Álvarez-Aguirre Alicia 
Published: June 2021

Abstract
Alcohol use presents a serious risk to women's health. Of particular interest is the association of harmful alcohol consumption and risky behaviors, such as drinking before sexual intercourse, an understudied phenomenon in the Mexican population.

Aim
The aim of this study was to identify whether the harmful use of alcohol is associated with an increased probability of presex drinking in Mexican young women.

Method
This was a study with a predictive design. Multiple logistic regressions were performed in a random sample of 304 young college women (between the ages of 18 and 24 years) from Guanajuato and Tamaulipas, Mexico. Participants completed a sociodemographic data survey and the Alcohol Use Disorders Identification Test questionnaire.

Results
Women with a pattern of harmful use of alcohol were more likely to report drinking before sex (adjusted odds ratio = 4.679, 95% confidence interval [1.619, 13.520], McFadden's pseudo R
2 = 25.5%). Further analyses revealed that presex drinking by partners was an even stronger predictor of alcohol use before sexual intercourse in women (adjusted odds ratio = 12.749, 95% confidence interval [4.714, 34.483], McFadden's pseudo R
2 = 34.7%).

Conclusions
The findings demand additional nursing studies to corroborate—and to better understand—the relationship between harmful use of alcohol in Mexican women, their partners' drinking behavior, and unhealthy behaviors like drinking before sexual intercourse.
Older Adult Patients Use More Aminosalicylate Monotherapy Compared With Younger Patients With Inflammatory Bowel Disease
Authors: Barnes Edward L. , Hanson John S. , Regueiro Miguel D. , Saha Sumona , Sands Bruce E. , Rubin David T. , Dubinsky Marla C. , Siegel Corey A. , Gazis Derek R. , Crawford Julie M. , Long Millie D. 
Published: June 2021

Goal:
The goal of this study was to describe medication utilization patterns in older inflammatory bowel disease (IBD) patients.

Background:
Despite a growing population of older patients with Crohn’s disease (CD) and ulcerative colitis (UC), questions remain regarding medication utilization patterns in comparison to younger populations.

Materials and Methods:
We collected data from the 34 sites in TARGET-IBD, a multicenter, observational cohort. The primary outcome in this study was the IBD-specific therapy utilized among older patients with IBD compared with younger age groups. Therapy use was analyzed using pairwise comparisons and then the odds of IBD-specific therapy use among patients older than age 65 were evaluated using multivariable logistic regression models.

Results:
We identified 2980 patients with IBD (61% CD). In multivariable analysis, younger patients with UC were significantly less likely to utilize aminosalicylate monotherapy when compared with patients above 65 years [age 18 to 29: adjusted odds ratio (aOR)=0.51, 95% confidence interval (CI): 0.33-0.78]. In patients with CD, younger patients were significantly less likely to use aminosalicylate monotherapy when compared with patients above 65 (greatest difference age 18 to 29: aOR=0.31, 95% CI: 0.18-0.52). Younger patients with CD and UC were significantly more likely to use anti–tumor necrosis factor monotherapy than patients above 65 years (age 18 to 29: aOR=3.87, 95% CI: 2.47-6.06 and aOR=2.68, 95% CI: 1.29-5.58, respectively).

Conclusions:
Older patients with IBD demonstrate significant differences in medication utilization, including more aminosalicylate monotherapy and less anti–tumor necrosis factor monotherapy compared with younger age groups. Given the aging population in the United States, these utilization patterns may have long-term implications for disease control.
A Pilot Randomized Trial of Polypectomy Techniques for 4 to 6 mm Colonic Polyps
Authors: Fatima Hala , Rex Douglas K. , Imperiale Thomas 
Published: June 2021

Background and Goals:
There is variation in polypectomy techniques for resection of small polyps. Aim was to compare techniques for 4 to 6 mm polyps for recurrent adenoma, efficiency, and adverse events and to establish methodological factors for definitive trial.

Materials and Methods:
The study was a randomized controlled trial. Outpatients with ≥1, 4 to 6 mm polyps were randomized to cold forceps (CF), cold snare (CS), and hot snare (HS). Polypectomy site was marked with SPOT to assess for recurrence at the original polypectomy site during surveillance colonoscopy. To assess feasibility of a definitive trial we measured (1) rates of patient refusal, participation, ineligibility; (2) retention; (3) recurrent neoplasia; and (4) sample size for a definitive trial.

Results:
Three hundred fifty-three patients were randomized to 1 of the 3 polypectomy techniques, of whom 260 (73.6%) completed the initial colonoscopy (mean age 57 y, 50.4% women), with 91, 87, and 82 patients randomized to CF, CS, and HS polypectomy, respectively. Mean time for polyp resection for CF, CS, and HS were 198.8, 58.5, and 96.8 seconds, respectively, with CS and HS requiring less time than CF (P<0.001). One hundred sixty-four (63.1%) completed surveillance colonoscopy. Polyp recurrences were 9 (14.5%) with CF, 5 (9.6%) with CS, and 0 (0%) with HS. Although the recurrence relative risks with CF and CS polypectomy were 1.84 and 1.65 as compared with HS, respectively, neither was statistically significant.

Conclusions:
CS and HS polypectomy require less time than CF. HS polypectomy may have a lower risk for recurrent neoplasia. High attrition rate is a challenge in conducting randomized controlled trial with polyp recurrence as endpoint.
RNA-sequencing of peripheral blood circular RNAs in Parkinson disease
Authors: Kong Fancong , Lv Zhanyun , Wang Lifang , Zhang Kui , Cai Ying , Ding Qingqing , Sun Zuzhen , Zhen Hefu , Jiao Fengjuan , Ma Qianqian , Nie Chao , Yang Yan 
Published: June 2021

Abstract

Background:
Circular RNAs (circRNAs) play an important role in many neurological diseases and can serve as biomarkers for these diseases. However, the information about circRNAs in Parkinson disease (PD) remained limited. In this study, we aimed to determine the circRNAs expression profile in PD patients and discuss the significance of circRNAs in the diagnosis of PD.

Methods and Results:
Using RNA-sequencing in peripheral blood RNAs, we showed that a significant number of mRNAs or circRNAs were differentially expressed between PD patients and normal controls (NCs), which included 273 up-regulated and 493 down-regulated mRNAs, and 129 up-regulated and 282 down-regulated circRNAs, respectively. Functional analysis was performed using the Kyoto Encyclopedia of Gene and Genomes (KEGG) pathway analysis, and the results showed that the second most enriched KEGG pathway was PD. These data suggest that the levels of mRNAs and circRNAs in peripheral blood could be potentially used as biomarkers for PD. In addition, we correlated mRNAs and circRNAs by constructing a competing endogenous RNA (ceRNA) network in PD. The resulted-in ceRNA network included 10 differentially expressed mRNAs from PD pathway, 13 predicted miRNAs, and 10 differentially expressed circRNAs.

Conclusion:
Collectively, we first characterized the expression profiles of circRNAs and mRNAs in peripheral blood from PD patients and proposed their possible characters in the pathogenesis of PD. These results provided valuable insights into the clues underlying the pathogenesis of PD.
Prognostic factors of chondroblastic osteosarcoma and nomogram development for prediction
Authors: Peng Cheng , Hao Yingjie , Ren Zhinan , Zhu Guangduo , Yu Lei 
Published: June 2021

Abstract
The present study aimed to develop nomograms to predict survival in patients with chondroblastic osteosarcoma (COS).
An analysis was conducted of 320 cases of COS collected from the surveillance, epidemiology, and end results (SEER) database between 2004 and 2015. Independent prognostic factors were screened using univariate and multivariate Cox analyses. Subsequently, nomograms were established to predict the patients’ cancer-specific survival (CSS) and overall survival (OS) rates. The prediction accuracy and discriminative ability of the nomograms were examined using calibration curves and the concordance index (C-index).
As revealed in the univariate and multivariate Cox regression analysis, age, tumor size, the primary site, the presence of metastasis, a history of having undergone surgery, and a history of having received radiotherapy were found to be independent prognostic factors associated with survival in patients with COS (all P < .05). Furthermore, age >39 years, the presence of distant metastasis, no history of having undergone any surgery, and tumor size >103 mm were found to be associated with poor prognosis in patients, while the primary site of the mandible and no history of having undergone radiotherapy showed associations with a more favorable prognosis in patients. Next, nomograms were constructed to predict the OS and CSS in patients with COS.
We constructed nomograms that can provide accurate survival predictions in patients with chondroblastic osteosarcoma. These nomograms can help surgeons customize the treatment strategies for patients with chondroblastic osteosarcoma.
CNKSR2 gene mutation leads to Houge type of X-linked syndromic mental retardation
Authors: Kang Qingyun , Yang Liming , Liao Hongmei , Wu Liwen , Chen Bo , Yang Sai , Kuang Xiaojun , Yang Haiyang , Liao Caishi 
Published: June 2021

Abstract

Rationale:
Mutations of connector enhancer of kinase suppressor of Ras-2 (CNKSR2) gene were identified as the cause of Houge type of X-linked syndromic mental retardation. The mutations of CNKSR2 gene are rare, we reporta patient carrying a novel nonsense mutation of CNKSR2,c.625C > T(p.Gln209∗) and review the clinical features and mutations of CNKSR2 gene for this rare condition considering previous literature.

Patient concerns:
We report a case of a 7-year and 5-month-old Chinese patient with clinical symptoms of intellectual disability, language defect, epilepsy and hyperactivity. Genetic study revealed a novel nonsense variant of CNKSR2, which has not been reported yet.

Diagnosis:
According to clinical manifestations, genetic pattern and ACMG classification of mutation site as Class 1-cause disease, the patient was diagnosed as Houge type of X-linked syndromic mental retardation caused by CNKSR2 gene mutation.

Interventions:
The patient was administrated with a gradual titration of valproic acid (VPA).

Outcomes:
On administration of valproic acid, he had no further seizures.

Lessons:
This is the first time to report a nonsense variant in CNKSR2, c.625C > T(p.Gln209∗), this finding could expand the spectrum of CNKSR2 mutations and might also support the further study of Houge type of X-linked syndromic mental retardation.
Efficacy and safety of chemotherapy combined with different doses of IL-2 maintenance therapies for acute myeloid leukemia
Authors: Yin Xuewei , Ding Yi , Yu Liming , Guo Chenchen , Cui Yanyan , Zhai Xixi , Wang Yan , Ding Shumin , Shen Mingyue , Li Zonghong , Xu Ruirong 
Published: June 2021

Abstract

Background:
Acute myeloid leukemia (AML) is the most common malignant tumor of the hematopoietic system, which seriously threatens the lives of patients. Most AML patients have acute onset, severe condition, and poor prognosis. The present study aimed to comprehensively evaluate the effectiveness and safety of chemotherapy combined with different doses of interleukin-2 (IL-2) maintenance treatments in AML by Bayesian network meta-analysis (NMA).

Methods:
From its inception until October 2021, we will search PubMed, Cochrane Library, CNKI, Embase, and other databases to comprehensively collect randomized controlled trials (RCTs) of chemotherapy combined with different doses of IL-2 maintenance therapies for AML. Two independent researchers will complete the literature screening and data extraction according to the inclusion and exclusion criteria, and then independently conduct a bias risk assessment of all the evidence. Bayesian NMA was used to evaluate all the evidence comprehensively. Use STATA16.0 and WinBUGS1.4.3 software to process and analyze all data, and classify the quality of evidence in NMA according to grading of recommendations assessment, development, and evaluation .

Results:
The study will evaluate the efficacy and safety of chemotherapy combined with different doses of IL-2 maintenance therapies for AML.

Conclusion:
The study will provide a basis for the efficacy and safety of chemotherapy combined with different doses of IL-2 maintenance therapies for AML. We hope that this study can provide meaningful support for clinicians and patients.

Protocol registration number:
INPLASY202140106

Ethical approval:
Since the study is based on published or registered RCTs, ethical approval and patient informed consent are abandoned.
Effects of respiratory training on pulmonary function, bad mood, and quality of life in patients with COVID-19
Authors: Zhu Jianfei , Long Qing , Mao Huihui , Ran Weirong 
Published: June 2021

Abstract

Background:
At present, whether respiratory training can improve the lung function, quality of life, and mental health of patients with Coronavirus Disease 2019 (COVID-19) is still controversial. Therefore, in order to provide new evidence-based medicine for clinical treatment, we conducted a systematic review and meta-analysis to evaluate the effects of respiratory training in improving lung function, quality of life, and mental health of patients with COVID-19.

Methods:
Relevant publications were searched from clinical trials. Computer was used to retrieve Cochrane Central Register of Controlled Trials Repositories, PubMed, Embase, and Web of Science databases. The retrieval time limit was from the establishment of the database to April 2021. Two researchers independently carried out data extraction and literature quality evaluation on the quality and meta-analysis of the included literature was performed with Revman 5.3 software.

Results:
The results of this meta-analysis will be submitted to a peer-reviewed journal for publication.

Conclusion:
This study will provide reliable evidence-based evidence on the effects of breathing training on lung function, bad mood, and quality of life in patients with COVID-19.

Ethics and dissemination:
Ethical approval was not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms.

OSF Registration number:
DOI 10.17605/OSF.IO/ZQTGY.
A rare case of diabetic ketoacidosis presenting with severe hypertriglyceridemia requiring plasmapheresis in an adult with type-2 diabetes mellitus
Authors: Roy Pooja , Koetter Paige , Cunningham Jessica , Komanduri Saketram , Cinicola John 
Published: June 2021

Abstract

Introduction:
Severe hypertriglyceridemia (HTG) is a rare complication of insulin resistance. Its presentation with diabetic ketoacidosis (DKA) has been reported in a few cases, where most patients have type-1 diabetes mellitus (DM). Our case represents a unique presentation of DKA associated with severe HTG above 10,000 mg/dL in an adult with type-2 DM.

Patient concerns and diagnosis:
Case Report: A 51-year-old man with no prior illnesses presented to the emergency department with abdominal pain and nausea. He was found to have DKA with a blood glucose level of 337 mg/dL, pH of 7.17, beta-hydroxybutyrate of 7.93 mmol/L, and anion gap of 20 mmol/L. His triglyceride levels were >10,000 mg/dL. His serum was found to be lipemic. Computerized tomography scan of the abdomen demonstrated mild acute pancreatitis. Negative GAD65 antibodies supported the diagnosis of type-2 DM.

Interventions and outcomes:
Endocrinology was consulted and one cycle of albumin-bound plasmapheresis was administered. This therapy significantly improved his HTG. DKA gradually resolved with insulin therapy as well. He was discharged home with endocrinology follow-up.

Conclusion:
This unique case highlights an uncommon but critical consequence of uncontrolled DM. It brings forth the possibility of severe HTG presenting as a complication of uncontrolled type-2 DM. Severe HTG commonly presents with acute pancreatitis, which can be debilitating if not managed promptly. Most patients with this presentation are managed with insulin infusion. The use of plasmapheresis for management of severe HTG has not been well studied. Our case supports the use of plasmapheresis as an effective and rapid treatment for severe HTG.
Distribution of complete blood count constituents in gestational diabetes mellitus
Authors: Zhang Yonggang , Zhang Yipeng , Zhao Limin , Shang Yanyan , He Dabao , Chen Jiying 
Published: June 2021

Abstract

Background (Trial Design):
The incidence rate of gestational diabetes is high. In the long run, it harms the health of both the mother and child. In order to understand the distribution of hematological cells with gestational diabetes mellitus (GDM), a longitudinal cohort study was conducted from 2012 to 2018.

Methods:
A longitudinal case control study of 1860 pregnant women was conducted between 2012 and 2018. Data of hematological parameters at 11 time points of gestational stage were obtained from a laboratory database. Repeated measures analysis and independent t-test were used to analyze the effect of the hematological parameters on GDM.

Results:
The trend of blood cells fluctuated with gestational age in normal controls but was more remarkable in GDM. Compared with the controls, blood neutrophils, lymphocytes, and monocytes augmented in the second trimester but decreased in the third trimester; platelet (PLT) and thrombocytocrit increased throughout the three trimesters, and red blood cell (RBC) was abundant in the last 2 trimesters in GDM.

Conclusions:
Peripheral blood leukocytes, platelets, and erythrocytes were significantly different during gestation between GDM and normal controls. Inflammation may also be involved in GMD.
Universal approach for full endoscopic decompression and percutaneous transpedicular fixation of the lumbar spine
Authors: Malo-Camacho Víctor Hugo , Bañuelos-Díaz Gerardo Enrique , Martínez-Velázquez Víctor Hugo , López-Ortega Luis , Malo-Macías Oscar , Villarreal-Ríos Enrique , Sosa-Gallegos Alejandro , Alva-Nájera Mauricio , Mejía-Valencia Mario Iván 
Published: June 2021

Abstract
Cohort study.
This study aimed to determine the effectiveness of the universal approach of full endoscopy and percutaneous transpedicular fixation via a medial central approach (ACM) performed to surgically treat patients with lumbar degenerative surgical pathologies.
Alternatives to interventionist treatments available to patients with lumbar degenerative surgical pathologies are related to recovery from minimally invasive surgery. Considering this, full endoscopic spinal decompression (full endoscopy) and percutaneous transpedicular fixation via an ACM represent advances in neurosurgical procedures, in particular, spinal surgery. Thus, the introduction of endoscopic and minimally invasive surgeries for the lumbar region has become 1 of the most important advances in modern surgery.
A cohort of 79 patients undergoing full endoscopy and percutaneous transpedicular fixation was evaluated 6 times in 1 year. Pain intensity was measured using the visual analog scale (VAS), and lumbar functionality was measured using the Oswestry Disability Index (ODI). Six evaluations were performed: before surgery and on discharge after surgery as well as at 1, 3, 6, and 12 months after surgery.
Before the ACM was applied, the VAS pain score was 8.52. At 11 hours post-surgery, the pain score reduced to 2.59 points (a difference of 5.73 points; P = 0.001). Of the 10 ODI domains evaluated, a difference was found between the period prior to surgery and 1 month later (P < 0.01).
The universal approach to full endoscopy and lumbar percutaneous transpedicular fixation via an ACM is highly effective for patients with lumbar surgical degenerative pathologies.
Organ failure, aetiology and 7-day all-cause mortality among acute adult patients on arrival to an emergency department: a hospital-based cohort study
Authors: Pedersen Peter Bank , Henriksen Daniel Pilsgaard , Brabrand Mikkel , Lassen Annmarie Touborg 
Published: June 2021

Background
Organ failure is both a frequent and dangerous condition among adult patients on arrival to an emergency department (ED). The risk of an unfavourable outcome could depend on the underlying aetiology. Knowledge of the relation between aetiology and prognosis could improve the risk stratification at arrival.

Objectives
To describe the relation between organ failure, aetiology and prognosis through 7-day all-cause mortality.

Methods
An observational three-year cohort study at the ED at Odense University Hospital, Denmark, including all acute adult patients.
First-measured vital signs and laboratory values were included to evaluate the presence of the following organ failures: respiratory, coagulation, hepatic, circulatory, cerebral or renal.
The primary outcome was 7-day all-cause mortality. Aetiological disease categories were based on primary discharge diagnoses. We described the association between 7-day mortality, aetiology category, site of organ failures and number of patients at risk.

Results
Of 40 423 patients with a first-time visit at the ED, 5883(14.6%) had an organ failure on arrival. The median age was 69 (IQR 54–80), and 50% were men. The most frequent aetiology was infection (1495, 25.4%). Seven-day all-cause mortality ranged between aetiologies from 0.0% (95% confidence interval [CI], 0.0–14.2) allergy) to 45.6% (95% CI, 41.3–50.0) (cardiac). Combining aetiology and site of organ failure, 7-day all-cause mortality was the highest in the cardiac category, from 14.8% (95% CI, 4.2–3.7) with hepatic failure to 79.2% (95% CI, 73.6–84.1) with cerebral failure. The combination of infection and respiratory failure characterised most patients (n = 949).

Conclusion
Infection was the most prevalent aetiology, and 7-day all-cause mortality was highly associated with the site of organ failure and aetiology.