As an important resource for a country to participate in international high-tech competition in the bio-pharma-ceutical field, clinical research resources play a key role in the multi-center clinical research and the translation from basic research to clinical practice.China has a large population and diverse diseases, but chinical disease research relevant policies and regulations are imperfect.In contrast, the United States has perfect laws and regulations related to clinical research.By comparatively analyzing the disease resource, platform support and regulatory environment between China and the U.S., this article offers suggestions on the development of clinical research resources so as to facilitate the clinical research in China.

In October 2015 ,the White House issued a New Strategy for American Innovation which was also concerned with precision medicine initiative , BRAIN initiative and health care .This paper introduces the background , main content and developments of this new strategy ,hoping to facilitate the development of healthcare in China .

Objective:To transfect human osteoprotegerin( o pg) gene into Cos-7 cells.Methods:The primers were designed b ased on the human opg cDNA sequence,total mRNA was isolated from 293 cells and RT-PCR was performed.The fragment of opg cDNA was inserted into pSecTag 2/B vector and sequenced by automatic sequence analyzer. The recombined plasmid was transfected into Cos-7 cells by Lipofectamine 2000 and OPG protein expressi on in Cos-7 cells was determined by immunohistochemistry and Western blot. Results:The sequence of opg cDNA from 293 cells obtained by RT- PCR was identical to the sequence provided by GenBank [gi:33878056]. The fragm ents of the recombinant plasmid digested with Hind Ⅲ,EcoR I and BamH Ⅰ and exa mined by 10 g/L agarose electrophoresis were consistent with predicted size.OPG over-expressing Cos-7 cells was selected and confirmed by immunohistochemistry and Western blot.Conclusion:Human opg gene may be transfect ed into Cos-7 cells.

Objective To develop an in vitro model for cranial suture of neonatal SD rat. Methods The parietal hones with the sagittal suture were removed from SD rats (19-days old) for organ culture. In the experimental group, tensile force 3.92×10~(-3) N (0.4 g) was applied by helical springs, whereas no tension (0 N) was set in control group. These explants were observed under inverted microscope. At the end of the incubation period for 24 hours, general conditions were observed under inverted microscope and histological conditions were observed after hematoxylin and eosin stain. Results Under inverted micro-scope, sutures had no obvious changes in control group, whereas sutures were enlarged gradually in the experimental group. With histological observation, sutures developed normally in control group, but in experimental group, osteohlasts and capillary vessels proliferated actively in the suture. Conclusions In vitro model of cranial suture can be cultured and grown successively.

Objective To evaluate the application of 64-slice computed tomography (CT) and software-assisted image analysis in preoperative evaluation and surgical planning of hilar cholangiocarcinoma. Methods The clinical data of six patients with hilar cholangiocarcinoma who were admitted to The First Affiliated Hospital of Sun Yat-sen University from June to December, 2009 were retrospectively analyzed. All six patients underwent 64-slice CT scanning before the operation, and then three-dimensional (3D) reconstruction of the liver, tumor, blood vessels and bile ducts was achieved with the assistance of Myrian (R) XP-Hepatic software. The relationships of the tumor, blood vessels and bile ducts were illustrated in the 3D model. Virtual liver resection was carried out for surgical planning. Results The 3D models of the liver, tumor, blood vessels and bile ducts were successfully constructed . The 3D models were able to be rotated and magnified as necessary. Preoperative evaluation and surgical planning were in accordance with actual surgery. The relative accuracy of the software-assisted image analysis system for calculating the hepatic volume to be resected was 5%. Patients recovered well without occurrence of hepatic failure. Conclusion Sixty-four-slice CT scanning and software-assisted image analysis are important for preoperative evaluation and surgical planning of hilar cholangiocarcinoma.

Objective To investigate precipitants of epileptic seizure, and to explore the correlation between various precipitants and relationship between precipitants and clinical features of epilepsy.Methods Data were collected from 154 patients attending a tertiary-care epilepsy clinic of Nanjing Brain Hospital between April 2015 and April 2016.The patients with epilepsy were older than 16 years, had a clinical history of one year or more, and one seizure at least a year and one seizure at least in the latest three months.An enclosed questionnaire was combined with open interview to identify and characterize seizure precipitants and clinical characteristics of patients.Patients were asked respectively whether there were some precipitants three months before and during last three months.Correlation between seizure precipitants and relationship between precipitants and clinical characteristics, such as age, gender, course, seizure frequency and so on, were calculated.Results A total of 125 (81.2%) participants reported at least one precipitant.Common precipitants (in descending order) were as follows: emotional stress (56.0%), sleep disorder (38.4%), fatigue (27.2%), missed medication (20.0%).There were one to six different precipitants for one patient, and 60.8% of patients had two or more precipitants.There was a correlation between emotional stress and sleep disorders as well as fatigue (χ2=4.665, 8.668;P<0.05).Patients with idiopathic epilepsy were more sensitive to sleep disorders.There was no relationship between total precipitants and clinical features such as age, gender, age of onset, duration, type of seizure, seizure frequency, number of drug taking and so on.Conclusions Seizure precipitants were found widespread.The most common precipitants were found to be emotional stress, sleep disorders, fatigue and missed medication.There existed a correlation between emotional stress and sleep disorders as well as fatigue.There was no connection between total precipitants and patient′s demographic characteristics as well as clinical features.However, the type of seizure precipitants was different in patients with different demographic and clinical characteristics.

Objective To observe curative effect of Ningdong granules on tourette syndrome (TS) concomitant with sleep disorder in children.Methods Eighty-three cases were diagnosed by diagnosis and statistics of mental-disorder (DSMIV) TS criterion and diagnostic standard of traditional Chinese medicine,and then were divided into 3 groups:tiapride hydrochloride group (n =25),Ningdong granules group (n =30) and tiapride hydrochloride plus Ningdong granules group (n =28).Yale global tic severity scale (YGTSS) and Athens insomnia scale (Athens) were used for rating the clinical efficacy before and after treatment.The enrolled children were treated for a period of three months.Results The therapeutic effective rate of TS in tiapride hydrochloride group,Ningdong granules group and tiapride hydrochloride plus Ningdong granules group was 92.0％,90.0％ and 96.4％,respectively.The therapeutic effective rate of sleep disorder was 84.0％,93.3％ and 96.4％,respectively.Mter treatment,YGTSS and Athens scores were significantly changed in all three groups (P ＜ 0.05).Athens score was significantly different between tiapride hydrochloride plus Ningdong granules group and tiapride hydrochloride group (P ＜ 0.05).The total number of adverse reactions was 16,1 and 8,with significant difference (P ＜ 0.01).Conclusion Curative effect of Ningdong granules is similar to that of tiapride hydrochloride on treating TS,but Ningdong granules is more effective than tiapride hydrochloride on treating sleep disorder with less adverse reactions.Combination therapy of Ningdong granules with tiapride hydrochloride is the better choice for treating TS with sleep disorder,and it can also reduce the incidence of adverse reactions of tiapride hydrochloride.

Objective To find out about the demands of health education in the border defense army .Methods A self-made questionaire was used to investigate both the demand of health education in the border defense army and the knowledge-attitude-practice of health .Comprehensive evaluation was conducted on the spectrum of disease in hospitals of border defense army in the previous year .Results Mental health (63.605%), lifestyle (53.829%) and knowledge on occupational protection (41.375%) were the most needed knowledge in the border defense army .Videos and lectures were the means of health education , accounting for respectively 69 .368%and 42 .936%.The total rate of awareness of knowl-edge about health education reached 64.156%.The total rates of holding health attitude and health behavior were 80.765%and 49.113%, respectively.Recently, intervertebral disc disorders,arthritis and other injuries (dislocation, sprain and strain ) were atop the disease spectrum at border defense hospitals .Conclusion Knowledge of mental health , lifestyle and occupational protection along with videos and lectures are the most urgent demand of the border defense army . What needs to be done right away is to improve the awareness of military occupation protection and develop healthy behaviors .

Objective To investigate therapeutic effect of the low dose clomiphene treatment of idiopathic oligoasthenospermia and effect on sperm epididymal protein level 4.Methods183 cases of idiopathic oligoasthenospermia were divided into three groups, vitamin group of 61 patients were given vitamin E,clomiphene group(61 cases)treated with low dose clomiphene, combined group of 61 patients were given low dose clomiphene and vitamin E, lasted for 12 weeks.Semen volume, sperm density, sperm motility, sperm survival rate and sperm reactive oxygen species (ROS), malondialdehyde (MDA), superoxide dismutase (SOD), human epididymis protein 4 (HE4), follicle stimulating hormone, luteinizing hormone, testosterone concentration were observed before and after treatment.After treatment, the patients were followed up for 1 year, the observation of the natural pregnancy rate after treatment.ResultsSperm density, sperm survival rate and sperm and a A+B grade sperm in the clomiphene group were significantly higher comparedwith the vitamin group (P< 0.05), sperm density, sperm survival rate and sperm and a A+B grade sperm in the combined group were significantly increasedcompared with clomiphene group and vitamin group (P< 0.05),levels of HE4 after treatment was significantly lower compared with before treatment (P< 0.05), And the difference between the three groups were statistically significant (P< 0.05).Follicle stimulating hormone, luteinizing hormone, testosterone in clomiphene group and combined group after treatment, were significantly increased compared with before treatment (P< 0.05), and the combined group had no statistically difference compared with clomiphene group.The pregnancy rate in 1 year of vitamin group, clomiphene group and combined group were 24.59%, 42.62% and 62.29% (P< 0.05).ConclusionClomiphene treatment of idiopathic asthenospermia is better than vitamin E, the combination of the two has a synergistic effect.