Case report form (CRF) is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion and statistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection should fully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields and standard coding for fields.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Documentation ; standards ; Research Design ; standards

Acute Coronary Syndrome ; therapy ; Angioplasty, Balloon, Coronary ; Humans ; No-Reflow Phenomenon ; prevention & control

Castleman's disease is a rare disorder of the lymphoid system characterized by noncancerous growths that may develop in lymph node tissues throughout the body. The incidence of this disease has been increasing in recent years. Because of the difficulty of diagnosis and high-misdiagnosis, more and more clinicians have paid close attention to this disease. By the clinical work, and with the help of related reports, the preliminary summary of this disease is made.

Objective To investigate the effect of psychological intervention combined with gliclazide and sitagliptin on the treatment of poorly obese obese patients with type 2 diabetes mellitus. Methods 96 obese patients with type 2 diabetes mellitus who had poor control of blood glucose after insulin treatment were randomly divided into control group and experimental group,48 cases in each groups. Gliclazide and sitagliptin (FBG), glycosylated hemoglobin (HbA1c), 2h postprandial blood glucose (2hPG), fasting insulin (FIns) were measured before and after 15 weeks of treatment in the control group. situation. Results FBG, HbA1c, 2hPG and FIns were significantly lower in the experimental group than in the control group (P<0.05). Conclusion The combination of gliclazide and sitagliptin on the treatment of poorly obese type 2 diabetes mellitus with insulin treatment can significantly reduce the blood glucose level of patients and promote it.

BACKGROUND:Bone marrow mesenchymal stem cel transplantation is a hot spot in the treatment of ischemic cerebrovascular diseases, and CT brain perfusion scan is mostly used to observe the improvement in the blood flow in the ischemic region. However, X-ray irradiation during CT brain perfusion may affect the viability of transplanted bone marrow mesenchymal stem cel s, and then influence the therapeutic efficacy. OBJECTIVE:To investigate the effect of CT brain perfusion dose on the viability of bone marrow mesenchymal stem cel s. METHODS:Passage 5 bone marrow mesenchymal stem cel s from Sprague-Dawley rats were selected and randomized into three groups, with 6 tubes in each group. One of the six tubes in each group was randomly selected with no irradiation, and the remaining five tubes in each group were subjected to CT brain perfusion scans 1-5 times, respectively. After scanning, the cel number was counted after 10-day continuous culture and cel growth curve of each tube was drawn. Cel cycle was detected by flow cytometry, and cel viability was measured by MTT method. RESULTS AND CONCLUSION:After 10 days of continuous counting, the number of cel s per tube showed no difference (P>0.05), and cel growth curves were basical y coincided. Moreover, there was no significant difference in the cel cycle and cel viability (P>0.05). Experimental findings show that the CT brain perfusion scan has no effect on the viability of bone marrow mesenchymal stem cel s.

Objective To study the effects of continuous oxygenated blood microperfusion on rat hearts preservation.Methods Forty-five Wistar rats were randomly divided into 3 groups.The isolated rat hearts were continuously microperfused with oxygenated blood at 4℃in experimental group,those in control group microperfused with St.Thomas solution and those in solution group were preserved with St.Thomas solution.After preservation the hemodynamic indexes of rat hearts were measured using Langendorff system,including the left ventricular end-diastolic pressure (LVEDP),the left ventricular systolic pressure (LVSP),the left ventricular developed pressure (LVDP) and the rate of the left ventricular pressure change (?dp/dt),then the contents of adenosine triphosphate (ATP) were determined by high-performance liquid chromatography and myoeardium ul- trastructures were observed under an electric microscope.Results After 30 min perfusion of Langen- dorff system,the LVSP,LVDP and?dp/dt were (38,25?3.84) mm Hg,(32.54?4.01) mm Hg and (1080?123) mm Hg/s respectively in experimental group;(34.48?4.68) mm Hg,(19.27?4.63) mm Hg and (935?196) mm Hg/s respectively in control group;(32.14?4.95) mm Hg, (16.99?4.85) mm Hg and (825?302) mm Hg/s respectively in solution group.The hemodynamic indexes in experimental group were superior to those in control group and solution group (P

Objective To explore the preventive and therapeutic effect of recombinant human interleukin-11(rhIL-11) on thrombocytopenia in children with non-lymphocytic leukemia after chemotherapy.Methods Sixteen children who had non-lymphocytic leukemia were divided into 2 groups by randomization,including a therapeutic group and a control group.RhIL-11[50 ?g/(kg?d)] was injected subcutaneously 24 h after chemiotherapy in the therapeutic group,and applied consecutively 10-14 days,and the control group was treated without RhIL-11.Duration of the thrombocytopenia,infusion of blood platelet,diversity of blood platelets counts and adverse effect were observed of the 2 groups.Differences between groups were examined using statistics analysis.Results There were 16 case-times(59.3%) in the therapeutic group that of could be cured without platelet transfusion,but that of control group only had 3 case-times(14.3%);the diffe-rence between 2 groups was significant(P

There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.
China ; Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; standards

Attitude to Health ; China ; Dust ; prevention & control ; Humans ; Needs Assessment ; Occupational Exposure ; prevention & control ; Occupational Health Services ; Pneumoconiosis ; prevention & control ; Surveys and Questionnaires