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

Objective To observe the effect of aerobic exercises on the expression of synaptophysin (SYP)and postsynaptic density protein-95 (PSD-95) in the prefrontal lobe of brain-aging rats induced by D-galactose (D-gal) and to explore the underlying mechanism of aerobic exercises relieving learning and memory deficits in the brain-aging process.Methods Thirty-six 3-month-old male Sprage-Dawley rats were randomly divided into a saline control group (C),a D-gal control group (D),and a D-gal and aerobic exercises group (DE),each of 12.The rats in both group D and DE were injected D-gal (100 mg/kg body weight) abdominally every day for 6 consecutive weeks,while those in group C were injected the same amount of saline.Meanwhile,the rats in group DE had performed aerobic swimming for 1 hour daily,while the other two groups did not do any exercises.Then,the Morris Water Maze (MWM) test was performed to estimate the learning and memory abilities.The immunofluorescence technology,Western blotting and real-time PCR were used to determine the expression levels of SYP,PSD-95,SYP mRNA and PSD-95 mRNA in the prefrontal lobe.Results In the process of navigation training,all animals' escape latencies shortened gradually,indicating that each rat was able to learn to locate the submerged platform.The rats in group C and DE showed best performance on day 3 and no significant improvement was observed thereafter,whereas those in group D improved at a slower pace,and reached maximal performance on day 5.On the 2nd,3rd and 4th days of the navigation training,the average escape latency of group D was significantly longer than that of group C and group DE (P＜0.05),while on the 1st,5th and 6th days,there was no significant difference among the 3 groups.In the probe trial,rats in group D spent significantly less time in the target quadrant compared with both group C and DE (P＜0.05),and rats in group C and DE crossed where the platform was fixed significanlty more often than group D (P＜0.05).The expression levels of SYP and SYP mRNA in the prefrontal lobe of rats in group D were significantly lower than group C (P＜0.01),and group DE (P＜ 0.05).Compared with group C,the expression levels of PSD-95 and PSD mRNA in the prefrontal lobe of rats in group D declined significantly (P＜0.01).There was no significant difference in PSD-95 expression between group D and DE,but the level of PSD-95 protein molecule of group DE was significantly higher than that of group D (P＜0.05).Conclusions The aerobic exercises can ameliorate the deficits of SYP and PSD-95 expression in the frontal cortex of aging rats induced by D-gal to some extent,and improve their learning and memory abilities.

Abstract: Objective　To analyze the epidemiological characteristics of 151 cases of melioidosis and the drug resistance of Burkholderia pseudomallei (BP), in order to provide the basis for diagnosis, treatment and reasonable prevention of melioidosis. Methods　A total of 151 inpatients and outpatients from the Second Affiliated Hospital of Hainan Medical University from January 1, 2013 to August 31, 2022 were collected, and clinical specimens were submitted for examination to isolate and identify BP strains. The clinical data of 151cases of melioidosis and the drug resistance characteristics of pathogenic bacteria were retrospectively analyzed, and using SPSS26.0 software for statistical analysis. Results　Among 151 cases with BP infection, there were 138 males (91.4%) and 13 females (8.6%); the most patients were aged from 45-<60 years old, accounting for 74 cases (49.0%); melioidosis incidence was concentrated in October (19.2%), November (19.2%), August (9.9%) and July (8.6%), and; the number of confirmed cases showed an increasing trend and the time for confirmation was <10 d; Internal medicine system (31.1%), surgery system (26.5%) and intensive care department (20.5%) were the common departments for treating melioidosis; blood (49.0%), sputum (9.9%) and wound secretion (8.6%) were the main clinical specimens for detecting BP; pulmonary infection (68.2%), sepsis (35.1%) and local suppurative infection (23.8%) were the top clinical manifestations in patients with BP infection; the effective rate of treating melioidosis was 74.8%; abnormal liver function was a risk factor for the curative effect of melioidosis (χ2=5.010, P<0.05); the sensitivity rates of BP strains to sulfamethoxazole-trimethoprim (SXT), doxycycline (DOX), imipenem(IPM), ceftazidime (CAZ), amoxicillin/clavulanate (AMC) and tetracycline (TCY) were generally more than 90%, with sensitivities of 98.7%, 97.2%, 96.7%, 94.0%, 93.2% and 90.7%, respectively. Conclusions　It can be concluded that misdiagnosis or missed diagnosis of melioidosis is easy to occur, and the understanding of the epidemiological characteristics and risk factors in this area should be strengthened. The sensitivity of BP to commonly used antibiotics has shown a certain downward trend, clinical use should be standardized, and drug resistance monitoring should be strengthened to improve the efficacy of melioidosis treatment.

Aim To screen a more suitable transfection recep-tor,and improve the efficiency of constructing cell lines highly expressing human peptide transporters 1 (hPepT1 ).Methods The recombinant plasmid pcDNA3.1 (+)-hPepT1 was transfect-ed into MDCK cells and HeLa cells by LipofectamineTM 2000 transfection reagent,respectively.The monoclonal cells were se-lected and cultured.Expression of hPepT1 mRNA and protein were determined by qRT-PCR and Western blot,respectively. The uptake capacity of Glysar in transfected cells was examined. Results Compared with wild type cells,the expression of hPepT1 and the uptake of Glysar in transfected MDCK cells and HeLa cells significantly increased (P <0.05).Although the up-take of Glysar in HeLa cells was higher than that of MDCK cells,on the contrary,the expression of hPepT1 and the uptake of Glysar in MDCK-hPepT1 cells was higher than that of HeLa-hPepT1 cells.Conclusion MDCK cells may serve as a more suitable transfected receptor for the construction of a cellular model with high expression of hPepT1 ,which would make the construction of a cell model highly expressing hPepT1 more effi-cient.

To study the chemical constituents of Artemisia lactiflora. The compounds were isolated by column chromatography with silica gel, C18 reverse-phase silica gel, semi-preparative HPLC, and their structures were elucidated on the basis of spectral analysis. Twelve compounds were isolated from alcohol extracts of A. lactiflora and identified as 7-hydroxycoumarin (1), 7-methoxycoumarin (2), balanophonin (3), aurantiamide (4), aurantiamide acetate (5), isovitexin (6), kaempferol-3-O-beta-D-rutinoside (7), rutin (8), caffeic acid ethyl ester (9), quercetin (10), methyl 3, 5-di-O-caffeoyl quinate (11) and methyl 3, 4-di-O-caffeoyl quinate (12), respectively. Compounds 3-12 were obtained from this plant for the first time.
Artemisia ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Molecular Structure ; Spectrometry, Mass, Electrospray Ionization

OBJECTIVETo observe the effect of TCM treatment according to syndrome differentiation in en-hancing curative effect and reducing side-effect of madopa in patients with Parkinson' s disease (PD).

METHODSThe trial was conducted in 101 PD patients with a prospective stratified randomized and controlled method. They were assigned to group 1 in which the patients of rigidity were treated with Pabing Recipe 1 (PR1) plus Madopa tablets, group 2 with those of tremor given Pabing Recipe 3 (PR3) plus Madopa tablets, and group 3 given a fixed Chinese recipe plus Madopa tablets as the control. The treatment course for all the groups was 3 months. Clinical efficacy was evaluated with unified Parkinson's disease rating scale (UPDRS) and the adverse reactions observed before and after treatment.

RESULTSAfter treatment, the 4 partial scores and the total score of UPDRS decreased significantly in group 2 (P<0.01), and the former of them and the total score declined in group 1 and 3 (P<0.01), the improvement was better in group 1 and 2 than that in group 3 (P<0.01); the improvement rate in group 1 to 3 was 95.5%, 100.0% and 83.7%, respectively, which was significantly higher in group 1 and 2 than that in group 3 (P<0.05).

CONCLUSIONTCM treatment according to syndrome differentiation could improve the clinical symptoms and reduce complications in PD patients, which could enhance curative effect and reduce side-effect of madopa.

Aged ; Aged, 80 and over ; Benserazide ; adverse effects ; therapeutic use ; Diagnosis, Differential ; Dopamine Agents ; adverse effects ; therapeutic use ; Drug Combinations ; Drug Synergism ; Drug Therapy, Combination ; Drug-Related Side Effects and Adverse Reactions ; etiology ; prevention & control ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Levodopa ; adverse effects ; therapeutic use ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Parkinson Disease ; diagnosis ; drug therapy ; Phytotherapy ; Prospective Studies ; Syndrome ; Treatment Outcome

Objective To investigate the production path of major histocompatibility complex class Ⅰ chain-related gene A(MICA) antibodies and the impact on the therapeutic efficacy after acute rejection in renal transplantation recipients.Methods Luminex flow cytometry was used to detect antiMICA antibodies and the antibody specificity in 157 pre-transplant kidney transplant recipients randomly selected.The clinical data were collected,anti-MICA antibody production pathway and immunoglobulin types were analyzed,and the impact of IgM anti-MICA antibody and IgM&IgG complex anti-MICA antibodies on acute rejection (AR) incidence and therapeutic efficacy after renal transplantation.Results Of the total 157 recipients,19 recipients were positive for anti-MICA antibodies before renal transplantation in 68 recipients who had history of blood transfusion,pregnancy and transplant sensitized experience (27.9％ ); In 89 recipients having no sensitized experience,MICA antibodies were positive in 26 recipients (29.2％ ) (P＞0.05).In 45 anti-MICA antibody-positive recipients,the anti-MICA antibodies type was IgM in 26 cases having no sensitized experience; and that was IgG and IgM complex in 19 cases having sensitized experience.In 38 antiMICA antibody-positive recipients undergoing kidney transplantation,7 out of 22 IgM anti-MICA antibodies recipients had AR (31.8％) that was reversed by methylprednisolone pulse therapy,and 7out of 16 IgM&IgG complex anti-MICA antibodies recipients had AR (43.8％) and treated with methylprednisolone pulse therapy:reversion in 3 recipients (42.9％),and the graft function loss in 4 recipients.The AR incidence was not associated with the two immunoglobulin types of MICA antibodies(P＞0.05),but there was significant difference in the reversal rate of AR (P＜0.05).Conclusion For non-allergenic history recipients,there exists the classic “natural antibodies” pathway in the production of the anti-MICA antibodies whose immunoglobulin type was IgM.In addition,the reversal effect of AR in recipients with IgM anti-MICA antibodies was much better.We need to attach importance to IgM&IgG complex anti-MICA antibodies for the pre-transplant anti-MICA antibodies in renal transplant recipients,because their AR treatment outcome is poor.

Objective To observe the treatment of ~(99)Te-MDP on typeⅡcollagen induced arthritis (CIA)in rat,and the effect on the expression of synovial MMP-3 and TIMP-1 mRNA.To explore the mech anisms of the ~(99)Te-MDP in the treatment of rheumatoid arthritis.Methods The rats in which C1A(n=24)were divided into three group:the control group(n=8),~(99)Tc-MDP group(n=8)and Methotrexate group(n=8). Arthritis were evaluated by arthritis index and histopathological index and the expressions of MMP-3 and TIMP-1 mRNA in synovium were detected by RT-PCR.Results①The arthritis indexs of the control group, the methotrexate group,the ~(99)Tc-MDP group were increased with time.②The histopathological scnres of the control group were significantly higher than those of methotrexate group and ~(99)Tc-MDP group(P＜0.01).The histopathological scores of cartilage destruction and bone erosion of ~(99)Tc-MDP group were lower than those of methotrexate group(P＜0.05).③The levels of MMP-3 mRNA of the control group,~(99)Tc-MDP group, methotrexate group were notably higher than those of the control group(P＜0.01).The levels of control group was notably higher than that of the ~(99)Tc-MDP group(P＜0.05).There was not significant difference in all groups on the levels of TIMP-1 mRNA(P＞0.05).Conclusions ~(99)Tc-MDP can notably relieve the arthritis symdrome and retard the catilage damage and bone erosion of CIA in rats,and could significantly decrease the MMP-3 mRNA in the synovium.Which may be one of the therapeutic mechanism.~(99)Tc-MDP is better than methotrexate in retarding catilage and bone erosion and decreasing MMP-3 mRNA in CIA rats in a 3-week therapeutic intervention.

Objective To explore the liver toxicities of the VDLD scheme in children with malignant tumor.Methods In a prospective trial,the levels of serum total protein,albumin, globulin,rate of albumin/globuin alanine aminotransferase,aspartate transaminase,gamma glutamyltranspeptidase,total bile acid and alkaline phosphatase were tested in children with malignant tumour before and after VDLD scheme,and compared with each other.Results The concentration of the serum total bile acid was significantly increased after VDLD scheme than before(P

Objective To study the effect of nickel-titanium stent(NTS) and consequent anti-allergy dexamethasone therapy on macrophage cells reactivity to lipopolysaccharide (LPS) from gram-negative bacterium .Methods The macrophage cell line Raw 264 .7 and dexamethasone-pretreated Raw264 .7 were co-cultured with NTS for 4 days ,and stimulated with LPS for 24 hours .The surface marker CD molecules of CD80 ,CD86 and FasL were detected with flowcytometr method ,the supernant cytokine production of proinflammatory cytokines IL-6 and TNF-αwas valued with ELISA method ,and intracellular inflammatory signal pathway acti-vation of NF-κB ,GAS ,ISRE and STAT3 was checked with signal molecule specific promoter lunciferase analysis .Results The stent pre-treatment improved LPS-mediated CD80 expression ,suppressed FasL production ,decreased IL-6 secretion and NF-κB ac-tivation ,the results have statistical significance (P<0 .05) .The dexamethasone treatment improved stent-mediated up-regulated ex-pression of CD80 ,FasL and TNF-α,and suppressed the activation of intracellular inflammatory signal pathway of NF-κB ,ISRE and STAT3 ,the results have statistical significance(P<0 .05) .Conclusion NTS inhibit macrophage cells Raw264 .7 react to TLR4 ag-onist LPS ,and dexamethasone treatment improved the function .