A 77-year-old man was admitted to our hospital at July 5th,2010 with an unexplained massive pericardial effusion for 10 years.With dyspnea for one month and normal vital signs without pulsus paradoxus,other physical examination included a small amount of moist rale,normal heart sounds,jugular vein engorgement,positive hepatojugular reflux,hepatosplenomegaly and pitting edema of the extremities.The patient had a complex past history with lymph node tuberculosis,primary artertial hypertension,polycythernia vera,chronic renal insufficiency and hypothyroidism (Hashimoto's thyroiditis),and moreover,received a high dose radiation of 31p in 1967. Family history is negative.The patient had no cardiac tamponade or pericardial constriction during 10 years,he received pericardiocentesis twice,and pericardial effusion was exudative with a high proportion of monocyte.There was no evidences of tuberculosis infection,hypothyroidism,malignant tumor,severe heart failure,uremia,trauma,severe bacterial or fungus infection,chronic myeloid leukemia or bone marrow fibrosis during the admission. The patient refused anti tuberculosis,indwelling catheter drainage or surgical therapy.In this rare case,the aetiology of chronic massive pericardial effusion is most probably chronic idiopathic recurrent pericarditis.

Objective To summanrize the operative method and follow-up data of total aortic arch replacement combined with transaortic stented graft implantation into the descending aorta (Sun's procedure) for acute Stanford type A aortic dissection.Methods Between August 2004 and March 2012,73 patients with acute type A aortic dissection underwent this procedure.60 males and 13 females ranging in age from 26 to 79 years (mean age,49,6 years).Right axillary or femoral artery cannulation was routinely used for cardiopulmonary bypass.Cerebral protection was achieved by bilatero-antegrade or selected hrain perfusion.The stented elephant trunk was implanted throuugh the aortic arch under hypothermic circulatory arrest.The stented elephant trunk was a 10cmlong self expandable graft.Patent false lumina were evaluated using computed tomography 3 months and once each year after discharge to evaluate the postoperative time course of the residual false lumen.Results Mean cardiopulmonary bypass time was (248.1±69.8)min,and selected cerebral perfusion time was (38.2±10.5)min.Hospital morality was 6.85 ％ (5/73).Thrombus obliteration of the residual false lumen in the descending thoracic aorta was observed in 9 1.7％ of the aortic dissections 3 months postoperatively.The mean follow-up time was(36.4 ± 31.6)months (range,2 to91 months).Survival at 1,5,7 years was 97％,87％ and 81％,respectively.Conclusion Total aortic arch replacement combined with transaortic stented paft implantation into the descending aorta is an effective treatment and n more promising choice for acute type A aortic dissection.

Objective: To understand the clinical manifestation, imaging characteristics and outcomes of pulmonary malignant tumors in children. Method: We retrospectively collected information about seven cases of pulmonary malignant tumors in children in our hospital from Jan 2010 to Dec 2016. The information included clinical manifestation, imaging characteristics, pathologic results, and treatment. Result: (1) All the seven patients firstly visited pediatric internal medicine departments. Symptoms included cough (n=6), dyspnea (n=4), fever (n=2), anorexia (n=2), chest tightness (n=1), chest pain (n=1), lameness (n=1), abdominal distension and constipation (n=1). We did not find hemoptysis, wheezing or weight loss in those patients. Physical examinations revealed unilateral reduced breath sounds (n=5), moist rales and wheezes (n=1), and normal (n=1). Extrapulmonary signs included abdominal distension (n=2), left hip tenderness (n=1), and mass in left scrotum. We did not identify clubbing finger, anemic appearance, lymph node enlargement, or hepatosplenomegaly etc. (2) Laboratory examination results: complete blood count showed white blood cells in normal range except one case (17.44×10⁹/L). Neutrophil percentage ranged from 0.348 to 0.767. C reactive protein ranged between<1 and 162 mg/L. Hemoglobin was normal. Three out of four cases had abnormal blood tumor markers.(3) Imaging results showed multiple nodes (n=3), multiple cystic lesions in lungs (n=2) (both with pleuropulmonary blastoma), endobronchial soft tissue mass (n=1), pulmonary round-shaped mass (n=1), and mediastinal mass (n=1). Imaging results also found atelectasis (n=3), pneumonia (n=2), pneumothorax (n=2), longitudinal diaphragmatic hernia (n=2), pleural effusion (n=1), subcutaneous emphysema (n=1). (4) All the patients underwent tumor puncture biopsy or tumor resection. Pathology revealed the final diagnosis of pleuropulmonary blastoma (n=3), endodermal sinus tumors (n=2), squamous cell carcinoma of lung (n=1), and thyroid papillary carcinoma (n=1). All of them were malignant tumors. We followed up them. Two patients died (both with pleuropulmonary blastoma) after their parents refused any medical help. Two cases were lost to follow-up. Three patients survived (followed up for 19 months, 11 months and tow months, respectively). One case with thyroid papillary carcinoma pulmonary metastasis underwent right thyroid cancer radical plus left thyroid lobe resection plus modified selective central lymph node dissection, then iodine ¹³¹ treatment. One case with endodermal sinus tumor pulmonary metastasis underwent three times of chemotherapies, resection of left retroperitoneal tumor and left testicular tumor, and six additional chemotherapies. Another one case of endodermal sinus tumor pulmonary metastasis underwent three times of chemotherapies and was discharged. Conclusion Pulmonary malignant tumors are rare diseases in children. Clinical signs are often non-specific. For those with chest CT showing multiple cystic lesions, endobronchial soft tissue mass or multiple nodes, but no significant infection manifestation or no response to anti-infection therapy, pulmonary malignant tumors should be considered. Biopsy may be needed to confirm the final diagnosis.

Objective:To provide decision-making support for electronic informed consent selection and promotion in clinical research, and lay a possible theoretical foundation for better protection of subjects′ rights and interests, as well as promotion of clinical research quality and efficiency.Methods:This paper summarized the relevant laws and regulations of electronic informed consent, analyzed the advantages and challenges of the application of electronic informed consent in clinical research, sorted out several common electronic informed consent modes in domestic clinical research, explored their operational processes and applications, and discussed their advantages and limitations.Results:At present, three electronic informed consent modes were mainly used in domestic clinical studies. Each had their own advantages and limitations in terms of convenience of operation, data security, privacy protection of subjects, cost input, popularization degree and so on.Conclusions:Electronic informed consent needs continuing improvement of relevant laws and regulations and the joint efforts of all stakeholders engaged in clinical research. The sponsor and the researcher should take full consideration of the cost, safety, security, feasibility, and ofters, and make the selection according to the actual needs of the research.

Objective To assess the prognostic value of the serum level and its change of N-terminal pro-B-type natriuretic peptides(NT-proBNP)in the elderly with acute decompensated heart failure with preserved ejection fraction(HFpEF). Methods A total of 138 consecutive patients(≥ 65 years old) admitted in Geriatrics and Gerontology Department at Beijing Friendship Hospital were enrolled from June 2013 to June 2015.Demographic characteristics,combination of diseases,medication administration, laboratorial and echocardiographic data were recorded.Meanwhile,NT-proBNP levels at admission,7thday after admission,changes over 7 days were also recorded and calculated.At the end of 1 year follow up,all patients were divided into events group(n=72)with,and control group(n=66)without,adverse outcomes of heart failure death,heart failure readmission and all-cause death.The differences in NT-proBNP level at admission,7thday after admission,and its changed value and rate over 7 days were compared between the two groups.Logistic regression was used for analysis of independent risk factors for prognosis.And the cut-off points of NT-proBNP values to predict adverse events were determined by receiver operating characteristic (ROC)curve. Results NT-proBNP values were significantly higher at admission and at 7thdays after admission in the events group than in control group(P=0.000).There were no significantly differences in NT-proBNP level and its changes over 7 days between two groups(P= 0.370 and P= 0.272).Logistic regression analysis showed that NT-proBNP values at admission and 7thdays after admission,and NYHA functional classification were independent risk factors for adverse outcomes in 1 year in the elderly with HFpEF(all P<0.05).Furthermore,by the ROC curve,NT-proBNP values at admission and 7thdays after admission could predict adverse outcomes including composite endpoints of heart failure,re-admission,heart failure associated death,and all-cause mortality in 1 year. Conclusions Both the plasma NT-proBNP levels at admission and at 7thdays after admission have a correlation with prognosis in elderly patients with acute decompensated HFpEF,while changes of NT-proBNP concentration over 7 days could not predict adverse outcomes in this cohort.

Objective:To explore the development, application and practical experience of investigator-initiated integrated clinical research information platform.Methods:The process of developing and constructing an integrated clinical research platform in a tertiary hospital in Beijing was introduced, the functions and advantages of the platform were described and displayed, and the main problems and risk points in the development and construction process were analyzed.Results:The integrated clinical research platform meets the management requirements of clinical research initiated by investigators, and the standardized management of the whole life cycle of the project can be realized through the platform, and the key issues of data security, information capture, sharing and interoperability need to be further explored in terms of platform docking.Conclusions:The integrated clinical research platform effectively improves the standardization, management quality and efficiency of investigator-initiated clinical research.

Objective To compare early outcomes of the minimally invasive aortic valve surgery (MIAVS) through right parasternal mini-thoracotomy with conventional mitral valve surgery (AVS),and evaluate feasibility and safety of MIAVS.Methods From January 2017 to December 2017,60 patients undergoing elective AVS in Nanjing First Hospital were prospectively enrolled in this study.There were 32 male and 28 female patients with their age of 28-72 (46.5 ± 10.2)years.Using a random number table,all the patients were randomly divided into a port-access MIAVS group (MIAVS group,n =20) and a conventional AVS group (conventional group,n =60).MIAVS group patients received port-access cardiopulmonary bypass (CPB) establishment via femoral artery,femoral vein and right internal jugular vein cannulation through right the 3rd in tercostal space with 5-6 cm right parasternal incision in length.Special MIAVS operative instruments were used for mitral valve repair or replacement.Conventional group patients received mitral valve repair or replacement under conventional CPB through median sternotomy.Perioperative clinical data,morbidity and mortality were compared between the 2 groups.Results There was no death in-hospital or shortly after discharge in this study.CPB time [(106.0 ± 21.0) minutes vs (73.0 ± 15.0) minutes] and aortic cross-clamping time [(78.0 ± 10.0) minutes vs (47.0 ± 7.0) minutes] of MIAVS group were significantly longer than those of conventional group (P ≤ 0.05).Postoperative mechanical ventilation time [(7.0 ±4.2) hours vs (10.2 ±5.3)hours],length of intensive care unit (ICU) stay [(19.0 ± 4.0) hours vs (27.5 ± 8.0) hours] and postoperative hospital stay [(8.5 ± 2.5) days vs (13.0 ± 3.0) days] of MIAVS group were significantly shorter than those of conventional group (P ≤ 0.05).Chest drainage volume within postoperative 12 hours [(100.0 ±40.0)ml vs (410.0 ±80.0)ml] and the percentage of patients receiving blood transfusion (15.0％ vs 55.0％) of MIAVS group were significantly lower than those of conventional group (P ≤0.05).Patients were followed up for 1-12 months,and the follow-up rate was 96.7％.There was no statistical difference in postoperative morbidity or mortality between the 2 groups (P ＞ 0.05).Conclusions Minimally invasive aortic valve surgery through right right parasternal mini-thoracotomy is a safe and feasible procedure for surgical treatment of mitral valve diseases.MIAVS can achieve similar clinical outcomes as conventional AVS,with more quickly recovery and less blood transfusion,and is a good alternative to conventional AVS.

Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.

To meet China′s requirements for scientific and technological innovation and high-quality development in the new era, it is imperative to actively implement the innovation-driven development strategy and build high-level research hospitals. Beijing Friendship Hospital, Capital Medical University has been working to build a research hospital since 2018. The hospital promoted discipline construction through the development mode of discipline clusters, made the research wards as a platform, adopted the " shared comprehensive service" mode to improve the quality and efficiency of clinical research, and strengthened talent cultivation through such key measures as a new talent recruitment system. The mode has proved successful in such aspects as improving the ranking of scientific and technological value of hospitals and disciplines, introducing high-level talents, and outputting scientific and technological achievements, supporting by research wards for other departments of the hospital, and improving the efficiency and quality of clinical trials. Such a mode can provide reference for general hospitals in building research hospitals.

Faced with the increasing demand for technological innovation, how to effectively carry out and regulate the export of medical-related scientific research data has become an urgent issue. The author reviewed the current requirements and status of data export in China and abroad, as well as the relevant requirements for medical data management in China, and introduced the practical experience of the first data compliance export case of medical field in China. In view of the main difficulties in the management of medical-related scientific research data export, such as the lack of multi-professional background members of the project team, the difficulty in writing professional documents, the relatively single template, the lack of personalized templates suitable for different professional field, and the need for homogenization of regulatory standards and requirements, it is proposed to rely on a qualified third-party platform in the form of entrusted business, adopt the optional mode under the general declaration template, establish unified regulatory standards, pay attention to the important data and national core data involved in the data export, pay attention to the ethical issues, and replace the original data with derivative data, and keep to " necessity principle" and " minimization principle", so as to provide reference for medical institutions and management departments to strengthen the standardized management and security guarantee of medical-related scientific research data export.