bluuebunny/crossref_metadata_2025_split huggingface dataset:
Buzhong Tiaogan Formula for delaying colorectal liver metastasis (liver depression spleen deficient type)
Authors: Wang Zhi-Jie , Zheng Shi-Hang , Wang Xiao-Han , Zhang Yi-Zhe , Hao Shu-Lan , Liu Li-Kun , Wang Xi-Xing 
Published: December 2021

Abstract

Introduction:
Colorectal cancer has been ranked third among the most common cancers worldwide and raised to the second leading cause of cancer death with nearly one-tenth of cancer-related deaths globally, and nearly half of colorectal cancer patients present with or develop colorectal cancer liver metastasis (CRLM). Buzhong Tiaogan Formula (BTF) has been proven to treat CRLM in our team, but there are lacking of evidence on its effective in delaying colorectal liver metastasis (liver depression spleen deficiency type), so we will evaluate the efficacy and safety of BTF in preventing the occurrence of CRLM.

Methods:
This randomized controlled trial (RCT) will be carried out in 3 different hospitals in Shanxi Province planning to recruit 150 CRLM patients with the type of liver depression spleen deficiency. The control group will be treated by basic antitumor therapy and the treatment group will use BTF plus basic antitumor therapy. The primary outcomes will be quality of life of included patients, the time of occurrence of liver metastasis, the score of traditional Chinese medicine symptom for the type of liver depression spleen deficiency; and the secondary outcomes will include overall survival, progression-free survival, DFS, tumor microenvironment and immune state of the included patient. Safety evaluation will be recorded during the whole study. All data in this RCT will be analyzed by SPSS 23.0 software. This study has been approved by the Clinical Research Ethics Committee of Shanxi Province Hospital of Traditional Chinese medicine (2021Y-06016).

Discussion:
The results of this RCT will contribute to BTF for delaying colorectal liver metastasis (liver depression spleen deficient type). And the results from this RCT will be published in a relevant journal after finished.

Trial registration:
ChiMCTR2100005268 (September 4, 2021).
Effect and safety of anlotinib combined with S-1 for recurrent or metastatic esophageal cancer patients who refused or were intolerant to intravenous chemotherapy
Authors: Cai Jing , Zhou Shan , Luo Yuxi , Liu Anwen 
Published: December 2021

Abstract
This study aimed to evaluate the effect and safety of anlotinib combined with S-1 in the treatment of recurrent or metastatic esophageal cancer patients who refused or were intolerant to intravenous chemotherapy.
This study retrospectively reviewed 22 recurrent or metastatic esophageal cancer patients who refused or were intolerant to intravenous chemotherapy between June 1, 2018 and February 28, 2019. All patients did not previously receive anlotinib or S-1.
Of 22 patients, 20 patients had squamous cell cancer. Seventeen patients received at least 2 cycles of anlotinib plus S-1. The objective response rate (ORR) was 35.3%, and the disease control rate (DCR) was 82.4%. The median progression-free survival (PFS) was 3.5 months, and median overall survival (OS) was 5.2 months. In the first-line treatment subgroup, the ORR was 50%, the DCR was 80%, the median PFS was 4.5 months, and the median OS was 5.8 months. In the second-line and above treatment subgroup, the ORR was 14.3%, the DCR was 85.7%, the median PFS was 3.0 months, and the median OS was 3.7 months. The main adverse events (AEs) of anlotinib combined with S-1 were fatigue (58.8%), hypertension (47.1%), hemoptysis (29.4%), anemia (29.4%), nausea (23.5%), liver function damage (23.5%), albuminuria (17.6%), abdominal pain (17.6%), leukopenia (17.6%), neutropenia (11.8%), fever (11.8%), and hand-foot syndrome (11.8%). Grade 3 AEs included nausea (5.9%) and hypertension (5.9%), and no grade 4 or more AEs were reported.
Anlotinib combined with S-1 achieved promising disease control and satisfactory survival with tolerable safety in recurrent metastatic esophageal cancer who refused or were intolerant to intravenous chemotherapy.
The effect of non-pharmacological interventions on psychological stress and quality of life of parents of children with retinoblastoma
Authors: Wu Lei , Xiang Xitao , Guo Hong , Tan Hui 
Published: December 2021

Abstract

Background:
Retinoblastoma is the most common malignant tumor in infancy and early childhood. Due to the high incidences of intracranial metastasis and distant metastasis, retinoblastoma not only threatens the life of affected children, but also brings heavy mental stress to their parents. A strong mental stress often leads to anxiety, depression, and other adverse emotions, which is very unfavorable to the treatment and prognosis by generating great psychological pressure and reducing the quality of life of the family. Reducing the psychological stress of the parents and improving the quality of life of the family are beneficial to the treatment and prognosis of retinoblastoma in children. However, there are no recommended non-pharmacological therapies to reduce the psychological stress and improve the quality of life of the parents of children with retinoblastoma. This study aims to evaluate the effects of non-pharmacological therapies on psychological stress and quality of life of parents of children with retinoblastoma through a meta-analysis, thus providing clinical evidence.

Methods:
Randomized controlled trials reporting the effects of non-pharmacological therapies on psychological stress and quality of life of parents of children with retinoblastoma published before 2021 November will be searched in online databases, including the China National Knowledge Infrastructure, Wanfang, Chinese Scientific Journal Database, China Biomedical Literature Database, PubMed, Embase, The Cochrane Library, and Web of Science databases. The Cochrane Quality Assessment Manual will be used to assess the quality of the included literatures. Meta-analysis will be performed using Revman 5.4 software.

Results:
This study will evaluate the effects of non-pharmacological therapies on psychological stress and quality of life of parents of children with retinoblastoma via grading anxiety scores, depression scores, and quality-of-life scores.

Conclusion:
This study will provide a reliable evidence-based basis for non-pharmacological interventions on parents of children with retinoblastoma.

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. This review would be disseminated in a peer-reviewed journal or conference presentations.
OSF REGISTRATION NUMBER:
Long-acting versus short-acting granulocyte colony-stimulating factors among cancer patients after chemotherapy in China
Authors: Wang Genzhu , Zhang Yonghe , Wang Xiaoying , Sun Qiang , Xun Zhikun , Yuan Minglu , Li Zhongdong 
Published: December 2021

Abstract

Background:
Granulocyte colony-stimulating factors (G-CSFs) include long-acting ones and short-acting ones. They have been mainly applied in Chinese clinical practice for years to prevent neutropenia. However, which type of G-CSF is more superior has not been conclusively determined.

Methods:
A systematic literature search was conducted using the PubMed, Embase, Cochrane Library, clinical trials.gov, China National Knowledge Infrastructure, and WAN FANG databases for related studies published till August 2021. Revman 5.3 software was used to assess the effectiveness and safety of these 2 types of G-CSFs in patients undergoing chemotherapy.

Results:
Ten studies involving 1916 patients were included in our meta-analysis to compare the effectiveness and safety of long-acting G-CSFs and short-acting G-CSFs. We found that the incidence of febrile neutropenia (relative risk [RR] 0.82; 95% confidence interval [CI] 0.57–1.17), the recovery time of the absolute neutrophil count (mean difference –0.23; 95% CI –0.49 to 0.03), and the fatigue rate (RR 0.82; 95% CI 0.62–1.07) were similar between the long- and the short-acting G-CSFs. However, the long-acting G-CSFs significantly decreased the incidence (RR 0.86; 95% CI 0.76–0.96) and shortened the duration (mean difference –0.19; 95% CI –0.38 to 0.00) of severe (grade ≥3) neutropenia, and decreased the rate of bone and/or muscle pain (RR 0.75; 95% CI 0.58–0.98).

Conclusion:
Primary prophylaxis with long-acting G-CSFs was more effective and safer than primary prophylaxis with short-acting G-CSFs in Chinese adults undergoing chemotherapy.
Efficacy and safety of tacrolimus monotherapy versus tacrolimus-corticosteroid combination therapy for idiopathic membranous nephropathy
Authors: Gong Lifeng , Xu Min , Xu Wei , Tang Weigang , Lu Jingkui , Jiang Wei , Xie Fengyan , Ding Liping , Qian Xiaoli 
Published: December 2021

Abstract

Objective:
The objective of this meta-analysis was to compare the efficacy and safety of tacrolimus (TAC) monotherapy versus TAC-corticosteroid combination therapy in idiopathic membranous nephropathy (IMN) patients.

Methods:
Databases including PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, and Wanfang database were searched from inception to January 10, 2021. Eligible studies comparing TAC monotherapy and TAC-corticosteroid combination therapy in IMN patients were included. Data were analysed using Review Manager Version 5.3.

Results:
Seven studies were included in the meta-analysis. One randomized controlled trial and six cohort studies involving 372 patients were identified. Compared with TAC monotherapy, TAC-corticosteroid had a higher total remission at the sixth month (odd ratio (OR) 0.49, 95% confidence interval (CI) 0.31–0.78, P < .01). The two therapy regimens had similar complete remission rates (OR 0.79, 95% CI 0.43–1.48, P = .47) at the sixth month and similar relapse rates (OR 1.44, 95% CI 0.70–2.92, P = .32). TAC-corticosteroid combination therapy had a higher incidence of infection (OR 0.38, 95% CI 0.18–0.81, P = .01). The two therapy regimens had similar incidences of gastrointestinal symptoms (OR 0.96, 95% CI 0.34–2.70, P = .93), abnormal aminotransferase (OR 0.90, 95% CI 0.34–2.38, P = .84), and glucose intolerance (OR 0.58, 95% CI 0.32–1.07, P = .08).

Conclusion:
TAC-corticosteroid combination therapy had a higher total remission rate at the sixth month but had a higher incidence of infection than TAC monotherapy in the treatment of IMN. The two therapeutic regimens had similar relapse rates.
The value of intraoperative nerve monitoring against recurrent laryngeal nerve injury in thyroid reoperations
Authors: Pei Maowei , Zhu Siqi , Zhang Chunjie , Wang Guoliang , Hu Mingrong 
Published: December 2021

Abstract
Reoperative thyroidectomy is challenging for surgeons because of the higher incidence of recurrent laryngeal nerve (RLN) palsy. RLN identification is the gold standard during thyroidectomy; however, it is sometimes difficult to perform thyroid reoperations. In recent years, intraoperative nerve monitoring (IONM) has gained increased acceptance, and the use of IONM can be a valuable adjunct to visual identification. The aim of this study was to evaluate the value of IONM during thyroid reoperation.
A total of 109 patients who met our criteria at the Affiliated Hospital of Hangzhou Normal University from January 2010 to June 2020 were retrospectively analyzed and divided into the IONM group and the visualization-alone group (VA group) according to whether neuromonitoring was used during the operation. The patients’ characteristics, perioperative data, and intraoperative information including the RLN identification, time of RLNs confirmation, operative time, intraoperative blood loss, and the rate of RLN injury were collected.
Sixty-five procedures (94 RLNs at risk) were performed in the IONM group, whereas 44 (65 RLNs at risk) were in the VA group. The rate of RLN identification was 96.8% in the IONM group and 75.4% in the VA group (P < .05). The incidence of RLN injury was 5.3% in the IONM group and 13.8% in the VA group (P > .05). The incidence of surgeon-related RLN injury rate was 0% in the IONM group compared to 7.7% in the VA group (P < .05), but the tumor-related or scar-related RLN injury rate between the 2 groups were not significantly different (4.3% vs 3.1%, 1.1% vs 3.1%, P > .05).
IONM in thyroid reoperation was helpful in improving the RLN identification rate and reducing the surgeon-related RLN injury rate, but was ineffective in reducing the tumor-related and scar-related RLN injury rate. In the future, multicenter prospective studies with large sample sizes may be needed to further assess the role of IONM in thyroid reoperations.
Musculoskeletal manifestations in Alkaptonuria
Authors: Khan Aysha Habib , Afroze Bushra , Majid Hafsa , Zaidi Yusra , Jamil Azeema , Jafri Lena 
Published: December 2021

Abstract
This study aimed to determine the patient characteristics and clinical presentation of Alkaptonuria cases reported by the Biochemical Genetics Lab.
An observational study was conducted at the Biochemical Genetics Lab. Alkaptonuria patients were diagnosed based on the homogentisic acid peak in urine and their demographics and clinical data collected from to 2013 to 2019. Clinical history related to joint diseases, ochronotic presentation, and urine darkening on standing was collected.
During 7 years, 21 Alkaptonuria cases were reported from BGL; mean age 19.4 ± 24.5 years (range 0.2–66 years) and male to female ratio of 2:1. Of the total, only 9 were adults (mean age, 44 ± 12 years). Most adult patients had musculoskeletal involvement, with joint pain (n = 9) and ochronotic pigmentation (n = 6), whereas all patients presented with a history of urine darkening on standing (21/21 cases).
The high prevalence of musculoskeletal involvement observed in patients with albuminuria is likely to be missed by physicians unless specifically tested for in such cases.
Bordetella bronchiseptica infections in patients with HIV/AIDS
Authors: Gujju Veena R. , Akram Bushra , Shibib Dena R. , McGhee Miranda A. , Drevets Douglas A. 
Published: December 2021

Abstract

Rationale:

Bordetella bronchiseptica is a common cause of upper respiratory tract infections in domesticated dogs and cats and a rare zoonotic pathogen in immunocompromised humans. With increasing numbers of people acquiring pets and spending time with them in confined spaces due to COVID-19 lockdowns, it is important to be aware of adverse health consequences brought about by this interaction. We present a case of B bronchiseptica pneumonia in a patient with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) and review key characteristics of an additional 30 cases of B bronchiseptica infections in 29 patients with HIV/AIDS that were identified by literature review.

Patient concerns:
A 61-year-old male with HIV/AIDS who was not on antiretroviral therapy and had advanced immunosuppression with a CD4+ T-lymphocyte count of 3 cells/μL sought medical attention for multiple somatic issues including subjective fevers, shortness of breath, and intermittent chest pain.

Diagnosis:
Computed tomography of the chest identified bilateral nodular opacities in the lower lobes with scattered areas of ground glass opacities. B bronchiseptica was identified in sputum culture by mass spectrometry followed by supplementary biochemical testing.

Interventions:
Empiric broad-spectrum antibiotics were initiated and changed to levofloxacin after susceptibility testing was completed.

Outcomes:
The patient was discharged after symptomatic improvement with levofloxacin.

Lessons:
Pneumonia with interstitial infiltrates in the setting of advanced CD4 lymphocyte depletion is the most common clinical syndrome caused by B bronchiseptica in patients with HIV/AIDS, and may be accompanied by sepsis. Advanced immune suppression, as well as chronic medical conditions, for example, alcoholism, diabetes, and renal failure that compromise host defenses are also commonly found in cases of B bronchiseptica infection in patients who do not have HIV infection. Reported animal contact among patients was not universal. Isolates were susceptible to aminoglycosides, carbapenems, fluoroquinolones, but typically resistant to most cephalosporins.
CCDC40 mutation as a cause of infertility in a Chinese family with primary ciliary dyskinesia
Authors: Liu Li , Zhou Kechong , Song Yuxuan , Liu Xiaoqiang 
Published: December 2021

Abstract

Trial design:
Primary ciliary dyskinesia (PCD) is a genetical disease that inherited in an autosomal-recessive way. Its clinical manifestations (such as male infertility) are mainly caused by defects of motion-related cilia that encoded by mutated genes. Although some mutation has been verified, a number of mutations of PCD remain elusive. The main purpose of this study is to identify mutant genes in a Chinese family with PCD, and to verify the safety and effectiveness of intracytoplasmic sperm injection (ICSI) of infertility caused by PCD.

Methods:
Imaging examination was used to exclude pulmonary inflammation and visceral translocation. Semen analysis was used to assess the quality of the proband's sperm. Transmission electron microscopy (TEM) was conducted to assess the ultrastructure of flagella and cilia. Targeted next generation sequencing and Sanger sequencing and qPCR (real-time quantitative polymerase chain reaction detecting system) were applied to identified mutation of Chinese Family suspected of having PCD. Viable sperm were selected by hypo-osmotic swelling test (HOST) for ICSI.

Results:
We report 2 novel mutations in CCDC40 gene (c.1259delA and EX17_20 deletion) resulted in immobility of sperm and infertility of the proband. These mutations were confirmed in the proband's sister (heterozygous) and his parents (recessive carrier) by Sanger sequencing and qPCR. All the spermatozoa from the proband were immotile. Ultrastructural defects were found in flagella and cilia of proband and his sister. Viable sperms were selected by HOST for ICSI and fertilized 9 of 21 eggs. Two frozen embryos were transplanted and a healthy 3500 g boy was delivered at 40 + 4 weeks’ gestation. And then, we summarized the genes related to PCD and the mutant sites of CCDC40 gene.

Conclusion:
We reported 2 novel mutants in CCDC40 gene (c.1259delA and EX17_20 deletion), which could be candidates for genetic diagnosis in PCD patients. The combination of targeted next generation sequencing and Sanger sequencing may be a useful tool to diagnose PCD. ICSI is a considerable method in treatment of infertility caused by PCD.
Efficacy and safety of the combination of modern medicine and traditional Chinese medicine in pulmonary fibrosis caused by novel coronavirus disease
Authors: Li Feiran , Wang Guanyu , Zhang Wei , Zhang Caiqing 
Published: December 2021

Abstract

Background:
Novel coronavirus disease (COVID-19) is a kind of pulmonary inflammation induced by New Coronavirus. It seriously threatens people's health and safety. Clinical studies have found that some patients have different degrees of inflammation after discharge from hospital, especially in patients with severe inflammatory lung fibrosis. Early combination of Chinese medicine and modern medicine has important clinical significance. There are still many deficiencies in the current research. We studied the effectiveness of the combination of traditional Chinese medicine and modern medicine in the treatment of pulmonary fibrosis caused by COVID-19, and proposed a network meta-analysis (NMA) scheme.

Methods:
According to the search strategy, we will search Chinese and English databases to collect all randomized controlled trials of traditional Chinese medicine combined with modern drugs or only using traditional Chinese medicine for new coronavirus-19-induced pulmonary fibrosis between December 1, 2019 and November 15, 2021. First, the literature was screened according to the eligibility criteria, endnotex9 was used to manage the literature, and the Cochrane Collaboration's tool was used to assess the quality of the included literature. Revman 5.3, Stata 14.2, and gemtc14.3 meta-analysis software was then used for data processing and analysis, and the grading of recommendations assessment will be used to develop and evaluate a hierarchy for classifying the quality of evidence for NMA.

Results:
Through the analysis, the ranking of efficacy and safety of various treatments for pulmonary fibrosis caused by COVID-19 will be drawn, thus providing stronger evidence support for the choice of clinical treatment methods.

Conclusion:
Traditional Chinese medicine (TCM) combined with modern drugs has played a positive role in the treatment of pulmonary fibrosis caused by COVID-19, and this study may provide more references for the clinical medication of pulmonary fibrosis caused by COVID-19.

INPLASY registration number:
INPLASY2021110061.
Nebulized enriched heparin to treat no critical patients with Sars-Cov-2
Authors: Bertanha Matheus , Rodrigues Lenize da Silva , Mellucci Filho Pedro Luciano , Moroz Andrei , Pardini Maria Inês de Moura Campos , Sobreira Marcone Lima , Durigon Edison Luiz , Machado Rafael Rahal Guaragna , Grotto Rejane Maria Tommasini , Lima Marcelo Andrade de , Nader Helena Bonciani , Moraes Marli Leite de , Barbosa Alexandre Naime , Medolago Natália Bronzatto , Cardoso Fábio Florença , Magro Angelo José , Carvalho Cristiane Rodrigues Guzzo , Moraes Leonardo Nazário de , Alvarado Rita de Cássia , Nunes Helga Caputo , Campos Gustavo Constantino de , Grillo Vinicius Tadeu Ramos da Silva , Sertorio Nathalia Dias , Fortaleza Carlos Magno Castelo Branco 
Published: December 2021

Abstract

Background:
Coronavirus disease 2019 (COVID-19) is a viral respiratory disease that spreads rapidly, reaching pandemic status, causing the collapse of numerous health systems, and a strong economic and social impact. The treatment so far has not been well established and there are several clinical trials testing known drugs that have antiviral activity, due to the urgency that the global situation imposes. Drugs with specific mechanisms of action can take years to be discovered, while vaccines may also take a long time to be widely distributed while new virus variants emerge. Thus, drug repositioning has been shown to be a good strategy for defining new therapeutic approaches. Studies of the effect of enriched heparin in the replication of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) in vitro assays justify the advance for clinical tests.

Methods and analysis:
A phase I/II triple-blind parallel clinical trial will be conducted. Fifty participants with radiological diagnosis of grade IIA pneumonia will be selected, which will be allocated in 2 arms. Participants allocated in Group 1 (placebo) will receive nebulized 0.9% saline. Participants allocated in Group 2 (intervention) will receive nebulized enriched heparin (2.5 mg/mL 0.9% saline). Both groups will receive the respective solutions on a 4/4 hour basis, for 7 days. The main outcomes of interest will be safety (absence of serious adverse events) and efficacy (measured by the viral load).
Protocols will be filled on a daily basis, ranging from day 0 (diagnosis) until day 8.