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

OBJECTIVETo observe the effect of external application of Zhuangshenling Recipe (ZR) combined with Western medicine (WM) on the heart function of chronic heart failure (CHF) patients of Xin-Shen yang deficiency, interior retention of water-fluid syndrome (XSYDIRWFS).

METHODSTotally 140 CHF patients of XSYDIRWFS were randomly assigned to two groups, the treatment group and the control group, 70 in each group. All patients received WM therapy. Those in the treatment group were applied with ZR at Xinshu (BL15) and Shenshu (BL23), while those in the control group were applied with placebos at Xinshu (BL15) and Shenshu (BL23). The therapeutic course for all was 12 weeks. The integrals of TCM syndrome, grading of cardiac function, brain natriuretic polypeptide (BNP), and 6 min walking distance were observed before and after treatment.

RESULTSAfter twelve weeks of treatment, the effective rate of improved grading of cardiac function, the total effective rate of TCM syndrome efficacy, and the BNP level were obviously better in the treatment group (P < 0.05). There was no statistical difference in 6 min walking distance between the two groups (P > 0.05).

CONCLUSIONExternal application of ZR combined with WM could improve the heart function of CHF patients of XSYDIRWFS.

Aged ; Chronic Disease ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Heart Failure ; drug therapy ; Humans ; Male ; Middle Aged ; Treatment Outcome ; Yang Deficiency ; drug therapy

Objective To investigate the patients with postoperative skin damage around the stoma after Miles operation,take measures according to the influencing factors,and explore an effective way to reduce the incidence of skin damage around the stoma patients.Methods There were 62 cases of skin damage around the stoma in 110 cases of patients with permanent colostomy in out-patient follow-up.Each patient with skin damage occurring around the stoma were retrospectively analyzed the reasons,and the related factors that might affect Miles postoperative stoma skin damage were analyzed.Results The incidence rate of Miles postoperative skin damage around the stoma was 56.36％,through the multi-factor Logistic regression analysis,there were six related factors with the Miles postoperative skin damage around the stoma,patients' excrement stimulation,ostomy bag allergies,improper operation of the replacement of the ostomy bag,the potential skin disease,excessive scrub / rub the skin,unfamiliar with ostomy care knowledge were the influencing factors of patients with skin damage around the stoma.Conclusions Appropriate stoma care products and paste methods,detailed guiding of patients and their families about ostomy care knowledge and skills can significantly reduce the incidence rate of Miles postoperative skin damage around the stoma.

Objective To explore the microbial etiology of early onset pulmonary infection after liver transplantation.Methods The 40 episodes of early onset pulmonary infection in 75 patients receiving liver transplantation in our hospital were reviewed and analyzed retrospectively.Results The incidence rate of pulmonary infection was 53.30% in these patients.A total of 54 pathogens were isolated,including 41(75.9%)strains of bacteria and 13(24.1%)fungal isolates.Gram-negative bacillus ac- counted for 68.3%(n=28)of the bacterial isolates,11(39.3%)of which were positive for extended spectrum?-lactamase. Gram-positive coccus accounted for 31.7%(n=13).Seven (58.3%)of the staphylococcal strains were methicillin-resistant. Conclusions The incidence of pulmonary infection is high early af- ter liver transplantation.Most of the isolated pathogens are drug resistant.Culture of sputum or secretion of lower respiratory tract and bedside X-ray examination are useful for the diagnosis.

Objective To compare the treatment effects,dosimetry,and toxicities to organs at risk of intensity-modulated radiation therapy (IMRT) and 3-dimentional conformal radiotherapy (3DCRT) plans for cervical carcinoma patients with recurrence and metastasis. Methods 62 cervical carcinoma patients with recurrence and metastasis were analyzed retrospectively, and divided into two groups including intensitymodulated radiation therapy group (n=29) and 3-dimentional conformal radiotherapy group (n=32).Patients were performed with 6 MV-X ray.The regimen was 1.8-2.2 Gy/f,1 f/d,18-33 times in total.Prescribed dose was 40-60 Gy and median dose was 52.8 Gy. At the same time for the IMRT group 29 cases were performed with 3DCRT, which was designed using the same prescribed dose to compare radiation dose distributed in organs at risk (OAR).Results The maximum dose of the two plans showed that bladder and small intestine in IMRT plans were lower than that in 3DCRT (P＜0.05), showing the IMRT's protective advantage. The maximum dose of PTV in IMRT plans were significantly higher than 3DCRT (P＜0.05). In the group of IMRT plans, the overall 1-,2-,and 3-year survival rates were 65.5 ％(19/29), 42.1％(8/19), and 25.0 ％(2/8),respectively,the median survival time was 19 months,of 28 deaths,21 patients died of tumor progression,7 patients died of distant metastases.In the group of 3DCRT plans,the overall 1-,2-,and 3-year survival rates were 60.6 ％(20/33),35.0 ％(7/20),and 14.3 ％(1/7),respectively,the median survival time was 17 months,of 32 deaths, 24 patients died of tumor progression, 8 patients died of distant metastasis. There were no significant differences in overall 1-, 2-, and 3-year survival rates between the two groups (P＞0.05). The incidence rate of toxicity in the IMRT plans was significantly lower than that in the 3DCRT plans, especially for patients with Ⅰ level and Ⅱ level.Conclusion The treatment effects of the IMRT plans are better than the 3DCRT plans for cervical carcinoma patients with recurrence and metastasis. IMRT plans can improve radiation dose in tumors and reduce the dose distributed in normal issue and reduce the incidence of the side effect.

AIM: To investigate the feasibility and clinical effect of punctoplasty by using trabeculectomy punch combined with a novel RS tube for the treatment of punctal stenosis.METHODS: Totally 39 patients (39 eyes) with punctual stenosis were selected from October 2013 to October 2015 in the Second People`s Hospital of Foshan.All patients underwent punctoplasty by using trabeculectomy punch combined with a novel RS tube.These tubes were removed at 3mo after operation.A follow-up of 6mo was taken for final analysis.The fluorescein dye disappearance test score was recorded before the operation and at 1,3 and 6mo after the extubation.The curative effect of the operation at 6mo after the extubation was assess.RESULTS: Fluorescein dye disappearance test: the scores at 1,3 and 6mo after the extubation all decreased compared with the preoperative ones.The difference was statistically significant(P<0.05).At the last following up, 35 eyes (90%) were cured completely, 4 eyes (10%) were improved significantly, no patients recurred.Effective rate was 100%.No serious intraoperative and postoperative complications happened.CONCLUSION: Punctoplasty by using trabeculectomy punch combined with novel RS tubes is a safe and effective method for the punctul stenosis, which is easy to perform, with high success rate.

Objective To investigate the effect of comprehensive intervention therapy of reducing fat on sex hormone and growth hormone(GH) in adolescent girl students with simple overweight and obesity.Methods Girl students with simple obesity were accepted a comprehensive measures composed of aerobicexercise,reasonable diet,behavior modification for 10 monthes,and their sex hormone and GH were detected and analyzed before,during and after test respectively.Results GH and estradiol(E_2) levels were significantly lower in obese subjects than those in normal subjects,but the level of testosterone(T) was highter,and GH and E_2 were increased obviously after reducing fat.Level of T decreased significantly(P

Through retrieval of all medical journals of CNKI and VIP from Jan. 1996 to Oct. 2012, ninety-nine articles were selected and analyzed. The result shows that reliable effect can be found in pain relieving, especially in pain of muscles and soft tissues. In mechanism research, action mechanism of Fu's subcutaneous needling (FSN) on pain relieving is expounded through theory of traditional medicine and modern medicine. Although the effect of FSN on pain relieving has been confirmed by numerous clinical trials, it is still lack of explanation on mechanism revealing. The further studies should focus on mechanism expounding, improving research methods and selecting more objective and reasonable evaluation system. Therefore, the effectiveness and scientificalness of FSN can be further enhanced.
Acupuncture Analgesia ; instrumentation ; methods ; Acupuncture Therapy ; instrumentation ; methods ; Humans ; Pain Management ; instrumentation ; methods ; Randomized Controlled Trials as Topic

As the most important antigen present cells in the processes of post-transplant complications in vivo, dendritic cells (DCs) play an important role in graft versus host disease (GVHD), infection, and relapse. DCs have became one of the most critical problems in the transplantation immune research recently. The reconstitution kinetics of circulating DCs after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and its relationship with the post-transplant complications, even the promoter or inhibitor affecting this process are summarized in this review.
Dendritic Cells ; immunology ; Graft vs Host Disease ; immunology ; prevention & control ; Hematologic Neoplasms ; immunology ; therapy ; Hematopoietic Stem Cell Transplantation ; adverse effects ; Humans ; Infection ; immunology ; Kinetics ; Neoplasm Recurrence, Local ; immunology ; prevention & control ; Transplantation, Homologous