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

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.

Abstract: Objective　This article summarizes the clinical characteristics and diagnosis and treatment experience of an elderly patient infected with Omicron variant BA.5.1.3 of COVID-19 in Hainan Province. Methods　The clinical data and treatment of an elderly patient infected with Omicron variant BA.5.1.3 of COVID-19 admitted to Haikou designated hospital on August 15, 2022 were retrospectively analyzed. Results　A 107-year-old female patient was admitted to the hospital with "fever and cough for 1 day". Two of her family members have infected with COVID-19. The patient initially developed fever, accompanied by cough, expectoration, a little white sticky sputum, accompanied by sore throat, muscle pain, fatigue. Nucleic acid test was positive in throat swab, indicating Omicron variant BA.5.1.3 infection. The patient was diagnosed as mild COVID-19 and treated with antiviral therapy, Chinese medicine conditioning, anticoagulation, electrolyte disorder regulation and symptomatic treatment for 9 days. The patient's clinical symptoms were relieved, and she was cured and discharged after two negative nucleic acid tests. One week later, the patient recovered well. Conclusions　Omicron variant BA.5.1.3 is highly infectious, and comprehensive treatment such as antiviral treatment and traditional Chinese medicine treatment has achieved good efficacy. For elderly patients, attention should be paid to maintaining the stability of organ function and internal environment, which is helpful to improve the prognosis of patients.

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

This study was aimed to construct a lentiviral vector of ha1 gene and obtain a stable packaging cell lines, which will be beneficial to guiding further study on the foundation of ha1 on the dissociation of graft versus host disease (GVHD) and graft versus leukemia (GVL) effect after allogenic hematopoietic stem cell transplantation (allo-HSCT). The targeting ha1 gene was obtained from plasmid T-ha1 by digesting. Then the ha1 gene was subcloned into the lentiviral vector pRRLSIN, cPPT, PGK/GFP, WPRE to construct a lentiviral vector carrying ha1 gene named pLenti-ha1 plasmid. And the pLenti-ha1 plasmid was confirmed by PCR, digesting and sequencing. 293T cells were co-transfected with lentiviral vector pLenti-ha1 and packaging system. The titer of virus was tested by real-time PCR. The results indicated that the construction of ha1 recombinant lentiviral vector was confirmed to be exact by PCR assay, digesting and sequencing; the assayed titer of virus was 2.0 × 10(8) TU/ml. In conclusion, the lentiviral vector of ha1 gene is constructed successfully.
Cell Line ; Gene Expression ; Genetic Engineering ; Genetic Vectors ; Humans ; Lentivirus ; genetics ; Plasmids ; genetics ; Transfection

Objective To identify the polyreactivity of a monoclonal natural anti-keratin autoantibody 3B4 and to analyze its possible molecular me chanism.Methods enzyme-linked immunosorbent assay (ELISA)and immunohistoche mistry were applied to test the binding reactivity of 3B4 against different anti gens and tissues.The variable region genes and their amino acid composition wer e sequenced.Results 3B4 could reacted with a range of antigens and tissues,i n addition to keratin and skin.The variable region genes of its light chain and heavy chain showed high homology with germline genes VK1 am4 and VH1 J558.42.H CDR3 region,which mainly composed of short side chain amino acids(from 294 to 324 nucleotides around the heavy chain),was the only motif that differs from ot her highly homologous immunoglobulin genes.Conclusions The monoclonal natural anti-keratin autoantibody 3B4,with its variable region genes highly homologo us to germline genes,is highly polyreactive.The flexibility of HCDR3 may contr ibute to the polyreactivity.

Objective To investigate plasma levels of total carnitine (TC) and free camitine (FC) in patients undergoing hemodialysis and peritoneal dialysis.Methods 200 cases of normal group came from physical examination in this hospital,all testing cases were the in-hospital patients in the department of nephropathy.TC and FC were determined by use of an enzymatic cycle assay on Hitachi 7170 automatic biochemical analyzer.Results In 200 cases of normal group,TC level was (56.52?9.61) ?mol/L,and FC was (46.60?8.23) ?mol/L.In 37 hemodialysis patients,TC and FC levels were (41.47?13.22) ?mol/L and (24.58?8.91)?mol/L before dialysis,a statistic difference was observed against the control group (P0.05).Conclusions Carnitine deficiency was seen in most patients undergoing hemodialysis and peritoneal dialysis.Furthermore,the deficiency status got worse along with the dialysis course in hemodialysis patients.Carnitine infusion can effectively improve the status of these patients.

Aged ; Biopsy, Needle ; methods ; Coal Mining ; Humans ; Lung ; pathology ; Lung Neoplasms ; complications ; diagnosis ; Middle Aged ; Pneumoconiosis ; complications

Objective To explore whether the degree of 99Tcm-methoxyisobutylisonitrile (MIBI) uptake in non-small cell lung cancer (NSCLC) could be correlated with the treatment response to three-dimensional conformal radiotherapy.Methods A total of 102 patients with NSCLC were studied with 99Tcm-MIBI SPECT before radiotherapy.The patients were classified by a follow-up CT as responders (complete or partial remission) and non-responders (stable or progressive disease).After intravenous administration of 740 MBq 99Tcm-MIBI, SPECT imaging at 10-30 min (early) and 2-3 h (delayed) were performed.Region of interest (ROI) was placed over the tumors and contralateral normal lung tissue.The uptake ratio of tumor to contralateral normal lung (T/N) was obtained from both early (ER) and delayed (DR) SPECT images.The retention index (RI) was measured as:RI = (DR - ER)/ER×100%.Statistical analysis was performed by two independent-sample t-test and Mann-Whitney U test using software SPSS 13.0.Results 99Tcm-MIBI uptake was significantly higher in responders than in non-responders:2.36 ±0.17 vs 1.82 ±0.14 (ER) and 2.48 ± 0.20 vs 1.94 ± 0.16 (DR), respectively (t = - 13.1,- 12.7, both P＜ 0.05).The median RI in the responders group was also significantly higher than that in the non-responders group (6.60% vs 5.13%, z = - 6.83, P ＜ 0.05).Conclusion ER, DR and RI of 99Tcm-MIBI SPECT might be useful to estimate the treatment response to three-dimensional conformal radiotherapy in patients with NSCLC.