This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.
Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards

Objective To study the effectiveness of the complete ureterel reconstruction using bladder flap after cadaveric renal transplantaion.Methods In 13 recipients with complete necrosis of ureter after renal transplant from July 1995 to October 2003, tubelike bladder flaps were applied to ureteraplasty substitute for the necrosis ureter. Artificial pyeloureterostomy was performed and double T tubes were used as the stents. Routine drainage-tubes were placed in incisions. Results All patients were successful in ureteral reconstruction. The renal function of 10 patients was improved significantly 4 weeks postoperation. Nephrectomy was performed in one patient because of severe circumrenal infection 7 days after operation. One-year survival rate of recipients and allografts was ~100 % (13/13) and ~92.3 % (10/13) respectively. Urine reflow occurred in 2 patients during a follow-up of 12 months. Conclusion The use of bladder flap for ureteral reconstruction is an effective technique for total autograft ureteral necrosis.

Adult ; Aged ; Aged, 80 and over ; Biliary Tract Neoplasms ; complications ; Cholangitis ; etiology ; Cholestasis ; etiology ; therapy ; Drainage ; adverse effects ; Female ; Hepatic Encephalopathy ; etiology ; Humans ; Intraoperative Period ; Jaundice, Obstructive ; etiology ; therapy ; Liver Neoplasms ; complications ; Male ; Middle Aged ; Pancreatitis ; etiology ; Stents ; adverse effects

BACKGROUND: Biliary tract complications are one of the most common postoperative problems after liver transplantation.Balloon dilation and percutaneous transhepatic biliary drainage (PTBD) has become an effective method to improve biliary complication after orthotopic liver transplantation (OLT).OBJECTIVE: To evaluate the balloon dilation and PTBD in the treatment of biliary stricture after OLT through case follow up.DESIGN, TIME AND SETTING: A total of 53 consecutive patients underwent interventional procedures to treat biliary stricture after OLT in the Department of Radiology, Beijing Chaoyang Hospital, Capital Medical University from July 1999 to March 2007 and were recruited for this study. The series included 46 men and 7 women, with 17-64 years of age. After OLT transplantation, all patients had abnormally elevated serum bilirubin level, and confirmed to suffer from obstruction of biliary tract by CT or MRI examinations.METHODS: Of 50 patients who received PTBD treatment, 36 underwent PTBD through right bile duct, 14 underwent bilateral (right bile duct and left bile duct) PTBD with 6 patients through left bile duct in the second treatment. A total of 13 underwent balloon dilation, and 3 were subjected to balloon dilation alone.MAIN OUTCOME MEASURES: An averaged 9.6 months of follow up was performed in 53 patients to observe obstructive jaundice recurrence induced by abnormally elevated serum bilirubin level after percutaneous transhepatic biliary interventional procedures.RESULTS: Follow up results showed satisfactory clinical outcome with obstructive jaundice resolved in all patients, except one patient, who received treatment with T tube, died of acute rejection at month 1 during the follow up, and one patient with liver failure had extremely poor prognosis after discharge at month 1 during the follow up. Obstructive jaundice was recovered even healed and serum bilirubin level was decreased to normal level in 51 patients at the end of follow-up. Primary success rate was 79% (42 in 53 cases), and assisted success rate was 21%. The first interventional procedure failed to treat obstructive jaundice in 5 patients. Obstructive jaundice recurred after primary percutaneous procedure in other 6 cases. No procedure related severe complications happened.CONCLUSION: Balloon dilation and PTBD are safe to treat biliary tract complication after OLT, without complication.

Adolescent ; Child ; Female ; Glomerulonephritis, IGA ; diagnosis ; pathology ; Humans ; Male ; Prognosis

Objective To analyze the occurrence of infections relative to percutanous biliary drainage(PTBD)or stenting for malignant obstructive jaundice and explore the therapy and prevention. Methods 181 patients(130 male and 51 female; median age 64.5 years old)with malignant biliary obstructive jaundice were investigated including 81 hepatobiliary cancers,42 pancreatico-ampullae tumors,58 gestro-intestinal portal lymphatic metastasis. All cases accepted PTBD or placement of metallic stents and the perioperative complications were recorded and analysed including the occurance and treatment. Results All cases accepted PTBD or stenting successfully. The perioperative biliary infection was the major complication including 50 out of 62 preoperative infected cases(34.25%). 18 cases(15.13%)suffered from biliary infection after operation with 13 under control,5 without control,4 complicated with pulmonary infection and 17(9.39%)died of serious biliary infections. Gram-negative bacilli and endotoxin were the main cause of the severe biliary infection. Postoperative mild pancreatitis occurred in 65 cases(35.91%)without severe necrotic changes and were cured after anti-inflammatory treatment. Hepatic abscess due to biliary leak occurred in 1 case(0.55%),and was cured by CT-guided drainage. Conclusion Biliary infection is the most common complication after interventional therapy and should be promptly under control for preventing mortality and prolonging survival. Simultaneously,acute pancreatitis should also be on alert but good prognosis would be obtained with apt therapy.(J Intervent Radiol,2007,16: 693-695)

Objective: To study the influence of high cell incubating temperature on AMP-activated protein kinase(AMPK) activity and lipid metabolites of piglets hepatocytes in vitro.Method: Primary hepatocytes of piglets about age 55d were separated and cultured under 37 ℃(control) or 42 ℃(heat stress).The anabolic and catabolic products of [14C]-oleic acid were detected for hepatocytes and culture media at 60min,120min and 180min.There were 9 replicates per time point.Result: Heat stress activated AMPK activity and enhanced fatty acid oxidation.The production of [14C]-CO2 and [14C]-acid soluble metabolites(ASM) was higher in heat stress group than in the control.At the same time,heat stress depressed the incorporation of [14C]-oleate into phospholipids,monoglycerides,triglycerides,cholesterol and cholesteryl ester.Conclusion: Heat stress activated AMPK activity and enhanced the formation of anabolic products and depressed catabolic products in piglets hepatocytes in vitro.

BackgroundIdiopathic epiretinal membranes(ERMs) is a common eye disease condition that leads to progressive decline of visual acuity. Studying the risk factors relating to this disease will shed light on its pathogenesis and allow opthalmologists to screen the affected individuals among the high-risk population and prepare for prevention and management strategies. ObjectiveThis survey was to investigate the risk factors of idiopathic ERMs in the population undergoing routine health check-ups. MethodsThe clinical data of idiopathic ERMs was obtained from the population of routine health check-ups in Peking Union Medical College Hospital from November 2009 to October 2010. The examination outcomes were compared between the individuals with and without idiopathic ERMs. The demographic and clinical factors associated with idiopathic ERMs were analyzed and assessed using univariate and multivariate logistic regression analyses. Result A total of 27 400 people were included in the survey and idiopathic ERMs were diagnosed in 76 cases. No obvious eye complaint was obtained from the idiopathic ERMs. The number of people affected with idiopathic ERMs was 12 ( 12/11 659 ) in the below 40 years group, 21 (21/4595) in the 51-60 years group and 32 (32/2544) in the over 60 years group. Hypertension, diabetes, diedyslipidemia, renal function insufficiency ,and cataract were found in 42％ ,5％ ,66％ ,6％ and 8％ of the patients, respectively. The univariate logistic regression analyses revealed that significant correlations were found between age,hypertension,hyperlipidemia and history of cataract( P＜0. 01 ). Multivariate regression models showed that the risk of idiopathic ERMs increased in age of 51-60( OR=2. 5,95％ CI:1. 2-5.4,P=0.02) and over 60 years( OR =7.3,95％ CI:3.4-15.6 ,P＜0.01 ) and patients suffering from hyperlipidemia ( OR--2. 1,95％ CI:1. 3-3.5, P＜0. 01 ). ConclusionsOver the age of 50 years and hyperlipidemia are primary risk factors of idiopathic ERM.

A novel drug delivery system combining oral fast dissolving film with sodium deoxycholate/phospholipid mixed micelles was prepared to increase the absorption of cucurbitacin B that is a poor aqueous solubility substance. Encapsulation efficiency, particle size, zeta potential, polydispersity coefficient, investigated the morphology, disintegration time of oral fast dissolving film and the pharmacodynamic properties of cucurbitacin B sodium deoxycholate/phospholipid-mixed micelles before and after solidified in mice were evaluated and compared. The oral fast dissolving film prepared in this study showed a homogeneous pale yellow and could completely disintegrated in the 30 s. It could meet the requirements of rapidly disintegrating fully. The encapsulation efficiency, particle size, zeta potential, polydispersity coefficient of cucurbitacin B sodium deoxycholate/phospholipid-mixed micelles loaded in oral fast dissolving film were (43.36 +/- 2.12)%, (108.82 +/- 5.2) nm, (-34.18 +/- 1.07) mV, 0.088 +/- 0.012, respectively. The encapsulation efficiency, particle size, zeta potential, polydispersity coefficient of cucurbitacin B sodium deoxycholate/phospholipid-mixed micelles in solution were (41.26 +/- 2.22)%, (181.82 +/- 4.48) nm, (-30.67 +/- 0.81) mV, 0.092 +/- 0.012, respectively. The difference of pharmacodynamics among film of cucurbitacin B-loaded micelles, cucurbitacin B-loaded micelles and free cucurbitacin B in vivo was compared. Solubility of cucurbitacin B loaded in sodium deoxycholate/phospholipid-mixed micelles has also been greatly improved. The tumor inhibition rate of cucurbitacin B loaded in sodium deoxycholate/phospholipid-mixed micelles was significantly improved and did not change significantly before and after solidified. These showed that the sodium deoxycholate/phospholipid-mixed micelles could enhance the antitumor activities of cucurbitacin B and the stability of cucurbitacin B sodium deoxycholate/phospholipid-mixed micelles was improved significantly after solidified by oral fast dissolving film technology without pharmacodynamic properties changed significantly.
Animals ; Antineoplastic Agents ; administration & dosage ; chemistry ; Cell Line, Tumor ; Deoxycholic Acid ; chemistry ; Drug Carriers ; chemistry ; Humans ; Male ; Mice ; Neoplasms ; drug therapy ; Phospholipids ; chemistry ; Solubility ; Triterpenes ; administration & dosage ; chemistry

Appropriate selection and measurement of lead biomarkers of exposure are critically important for health care management purposes, public health decision making, and primary prevention synthesis. Lead is one of the neurotoxicants that seems to be involved in the etiology of psychologies. Biomarkers are generally classified into three groups: biomarkers of exposure, effect, and susceptibility.The main body compartments that store lead are the blood, soft tissues, and bone; the half-life of lead in these tissues is measured in weeks for blood, months for soft tissues, and years for bone. Within the brain, lead-induced damage in the prefrontal cerebral cortex, hippocampus, and cerebellum can lead to a variety of neurological disorders, such as brain damage, mental retardation, behavioral problems, nerve damage, and possibly Alzheimer's disease, Parkinsons disease, and schizophrenia. This paper presents an overview of biomarkers of lead exposure and discusses the neurotoxic effects of lead with regard to children and adults.
Alzheimer Disease ; chemically induced ; metabolism ; pathology ; physiopathology ; psychology ; Animals ; Behavior ; drug effects ; Biomarkers ; metabolism ; Brain ; metabolism ; pathology ; physiopathology ; Brain Diseases ; chemically induced ; pathology ; physiopathology ; Environmental Exposure ; adverse effects ; Humans ; Lead ; pharmacokinetics ; toxicity ; Lead Poisoning ; etiology ; metabolism ; pathology ; physiopathology ; psychology ; Neurotoxicity Syndromes ; etiology ; metabolism ; pathology ; physiopathology ; psychology ; Parkinson Disease, Secondary ; chemically induced ; metabolism ; pathology ; physiopathology ; psychology ; Schizophrenia ; chemically induced ; metabolism ; pathology ; physiopathology