Open Access Journal of Clinical Trials最新文献

{"title":"The ADOPT trial (Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D) for Heart Failure Patients in China): rationale, design, and end-points","authors":"Bing Liu, F. Yi, H. Cai, Wen-yi Guo, Weijie Li, M. Shen, J. Xia, Li-wen Liu, Hai-Chang Wang","doi":"10.2147/OAJCT.S19583","DOIUrl":"https://doi.org/10.2147/OAJCT.S19583","url":null,"abstract":"Bing Liu1* Fu Yi1* hongwei Cai2 Wenyi guo1 Weijie Li1 Min shen1 Jielai Xia3 Liwen Liu4 haichang Wang1 on behalf of The ADOPT study steering Committee and investigators 1Department of Cardiology, Xijing hospital, FMMU, Xi’an, China; 2Department of information, school of stomatology, FMMU, Xi’an, China; 3Department of statistics, FMMU, Xi’an, China; 4Department of Ultrasound, Xijing hospital, FMMU, Xi’an, China","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2011-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S19583","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phenyramidol in acute conditions of lumbago, integumental pain and musculo-skeletal pain: an open label, noncomparative, multi-center study","authors":"Hitesh Shah, A. Shakeel, N. Karne, Chetan S Patil, Rajesh M Kewalramani, V. Kasodekar, Malhar Dave","doi":"10.2147/OAJCT.S18505","DOIUrl":"https://doi.org/10.2147/OAJCT.S18505","url":null,"abstract":"Objective: To assess the safety and efficacy of phenyramidol hydrochloride tablets in acute conditions of lumbago, integumental pain and musculo-skeletal pain. Methods: This open label, noncomparative, phase IV study recruited adult patients with acute lumbago, integumental pain and musculoskeletal pain who gave written informed consent. Those with elevated liver enzymes, or on analgesics, muscle relaxants, tranquilizers, anti-coagulants, or anti-epileptics were excluded as were pregnant/lactating women. 1 to 2 tablets of 400 mg phenyramidol were given orally 2 to 3 times daily for 3 to 7 days. Safety measures included complete blood count (CBC); liver and renal function tests; electrocardiogram (ECG); global assessments and adverse events. Efficacy measures included change in numerical pain rating scale (NPRS) score and global assessments. Results: 100 patients completed the study. There were no serious adverse events (SAEs) or deaths. The mean (SEM) reduction in the total white blood cell count [0.27 (0.13) thou/µL, P , 0.05] and the mean (SEM) increase in the serum glutamic pyruvic transaminase (SGPT) level [8.78 (3.40) U/L, P , 0.05] were not clinically significant at the end of the treatment period. Investigators’ assessment of safety was: 80% – excellent, 13% – good, 7% – fair. Tolerability grading by patients was: 53% – excellent, 34% – good, 12% – fair; 1% – poor. Out of the total 12 adverse events (AEs) recorded in 11% patients, 7 were clinical, while 5 were laboratory-related pertaining to increased liver enzymes (5%). The average NPRS score showed an improvement of 68% (P , 0.0001). Investigators assessed 89% patients to have clinically meaningful improvement, patients’ assessment of efficacy was: excellent – 43%; good – 38%; fair – 15%; poor – 4%. Conclusion: Phenyramidol is effective and well-tolerated in acute lumbago, musculoskeletal pain and integumental pain when given for up to 7 days. However it should be used with caution in patients with liver disease and with drugs known to cause liver damage.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2011-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S18505","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records","authors":"Keiichi Yamamoto, S. Matsumoto, K. Yanagihara, S. Teramukai, M. Fukushima","doi":"10.2147/OAJCT.S19579","DOIUrl":"https://doi.org/10.2147/OAJCT.S19579","url":null,"abstract":"Keiichi Yamamoto1 shigemi Matsumoto2 Kazuhiro Yanagihara2 satoshi Teramukai1 Masanori Fukushima1,2,3 1Department of Clinical Trial Design and Management, Translational research Center, Kyoto University hospital, Kyoto, Japan; 2Outpatient Oncology Unit, Kyoto University hospital, Kyoto, Japan; 3Translational research informatics Center, Foundation for Biomedical research and innovation, Kobe, Japan","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2011-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S19579","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Data retention after a patient withdraws consent in clinical trials.","authors":"André P Gabriel,&nbsp;Charles P Mercado","doi":"10.2147/OAJCT.S13960","DOIUrl":"https://doi.org/10.2147/OAJCT.S13960","url":null,"abstract":"<p><p>Patient retention is critically important in the conduct of a successful clinical trial. The power in numbers in multicenter trials is dependent on the completion of follow-up for every patient randomized. If at the end of a clinical trial, a significant number of randomized patients are missing outcome data, there will not be enough pool for data analyses to conclude a study based on its primary and secondary objectives. When patients who are either lost to follow-up or who withdraw consent during the clinical trial are eliminated from the data pool, they subsequently affect the power and the validity of conclusions derived from the clinical study. This paper aims to present current guidance on data retention for patients who have withdrawn consent from clinical trials.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S13960","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31648890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phase II trial of second-line erlotinib and digoxin for nonsmall cell lung cancer (NSCLC)","authors":"F. Kayali, M. Janjua, D. Laber, Donald M Miller, G. Kloecker","doi":"10.2147/OAJCT.S16347","DOIUrl":"https://doi.org/10.2147/OAJCT.S16347","url":null,"abstract":"Correspondence: goetz h Kloecker University of Louisville, 529 s. Jackson street, Louisville, KY 40202, UsA Tel +1 502 562 4358 Fax +1 502 562 6811 email ghkloe01@louisville.edu; goetzkloecker@yahoo.com Background: In vitro digoxin sensitizes cancer cells to the induction of apoptosis by c hemotherapy. Inhibition of the Na/K-ATPase enzyme by ouabain disturbs the intracellular ion composition of cancer cells, altering cellular homeostasis. This suggests that inhibition of the Na/K pump results in cellular sensitization of malignant but not benign cells to the induction of apoptosis. Epidemiologic studies have also shown beneficial effects of digitalis in breast cancer incidence. At ASCO (American Society of Clinical Oncology) 2007 our group presented a Phase II study showing encouraging results by adding digoxin to biochemotherapy for melanoma. Erlotinib is one of the standard second-line treatments for nonsmall cell lung cancer (NSCLC), with a response rate (RR) of 10%. This study’s hypothesis was that adding digoxin to erlotinib will improve the RR and time to progression (TTP) in NSCLC. Methods: Patients with progressive disease (PD) after chemotherapy were enrolled if they had an ECOG (Eastern Cooperative Oncology Group) score from 0 to 2 and good organ f unction. Daily erlotinib 150 mg and digoxin 0.25 mg were taken by mouth. The digoxin dose was adjusted to keep levels between 1 and 2 ng/mL. Computed tomography scans were done every 6 weeks. Treatment continued until PD or significant toxicity occurred. Results: Patient accrual lasted from March 2006 until August 2008 and was stopped early at the time of interim analysis. Twenty-eight patients were enrolled, and 24 who completed at least 6 weeks of therapy are presented here. All patients had unresectable NSCLC stage III/IV at diagnosis. Median age was 61 (34–78), 14 were female, 17 had prior radiation (not involving the target lesions), 23 had one prior chemotherapy, and one subject had two. Only one patient was a never-smoker. Histologies were 50% adenocarcinoma, 30% squamous, and 20% u nspecified. One patient had a partial response, nine had stable disease, and 14 had progressive disease. The median TTP was 61 days (9–366) and median survival 157 days (9–844). Side effects were similar to erlotinib single agent with no treatment-related mortality. There were no unexpected or increased adverse events related to digoxin. Conclusions: Digoxin did not increase the response rate of erlotinib in the treatment of p rogressive NSCLC. The TTP and survival seen in this study were similar to the published results with erlotinib alone. This combination does not warrant further clinical studies in NSCLC.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2011-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S16347","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prospective evidence that HIV lipoatrophy and visceral adiposity are partially independent processes","authors":"H. Wand, D. Carey, A. Calmy, M. Law, D. Cooper, S. Emery, A. Carr","doi":"10.2147/OAJCT.S14359","DOIUrl":"https://doi.org/10.2147/OAJCT.S14359","url":null,"abstract":"Correspondence: Handan Wand national Centre in HiV Epidemiology and Clinical research, University of new South Wales, Sydney, nSW 2052, Australia Tel +61 2 9385 0900 Fax +61 2 9385 0910 Email hwand@nchecr.unsw.edu.au Purpose: To investigate the patterns of change in objectively assessed body composition parameters and to determine to what extent the observed patterns correlate with modifiable variables and potential risk factors for lipodystrophy in human immunodeficiency virus (HIV)-infected lipoatrophic adults. Method: Changes from baseline in limb fat and visceral adipose tissue (VAT), and their associations with antiretroviral therapy, body composition, and metabolic variables were investigated using linear and logistic regression models. Results: Increases in limb fat were significantly associated with higher baseline limb fat (P , 0.0001), VAT (P = 0.023), and change from baseline to week 72 in VAT (P , 0.0001). On-study use of zidovudine or stavudine was negatively associated with a limb fat increase (P = 0.017). High baseline limb fat mass and VAT had negative effects on subsequent VAT increases at week 72 (P = 0.016 and P = 0.001, respectively). Conclusions: This large, prospective study in HIV-infected adults with moderate or severe lipoatrophy at baseline showed positive associations between changes in limb fat and VAT over 72 weeks. Risk factors for these two lipodystrophic features were different. Our findings suggest that lipoatrophy and fat accumulation are at least partially independent processes.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2011-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S14359","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retrospective analysis of a South African cardiovascular trial site’s patient retention rates","authors":"L. Burgess, N. Sulzer","doi":"10.2147/OAJCT.S13896","DOIUrl":"https://doi.org/10.2147/OAJCT.S13896","url":null,"abstract":"Correspondence: Lesley J Burgess TreAD research/Cardiology Unit, Department of internal Medicine, Tygerberg hospital and Stellenbosch University, Parow, South Africa Tel +27 21 931 7825 Fax +27 21 933 3597 email lesley@treadresearch.com Introduction: Patient dropouts negatively affect study cost and validity of study results. Objectives: To investigate the attrition rate and reasons for patient discontinuations at a cardiovascular trial site in South Africa. Methods: Studies conducted over the past 10 years were randomly selected and retrospectively examined for attrition rates and reasons for patient discontinuation. Results: A total of 50 studies with a duration ranging from 3 to 45 months were examined. A total of 1386 patients were randomized. Of these, 88.9% completed all scheduled study visits, resulting in a mean 11.1% (n = 154) attrition rate. Reasons for discontinuation included death (39.6%), withdrawal of consent (33.1%), adverse events (22.7%), and relocation (4.5%). There were no patients lost to follow-up. Conclusion: The low attrition rate and absence of any patients lost to follow-up are the result of a dedicated retention plan in which each site staff member has a crucial role to play in keeping patients motivated and interested in participating in a clinical trial.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2010-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S13896","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68412608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Examining the readability of patient-informed consent forms","authors":"Marli Terblanche, L. Burgess","doi":"10.2147/OAJCT.S13608","DOIUrl":"https://doi.org/10.2147/OAJCT.S13608","url":null,"abstract":"Correspondence: Marli Terblanche Room 41, Department of Cardiology, 8th Floor, Tygerberg Hospital, Parow 7500, South Africa Tel +27 21 931 7825 Fax + 27 21 933 3597 Email marli@treadresearch.com Primary objective: To investigate the readability of informed consent forms (ICF) used at TREAD Research, a private clinical trial research unit located in Tygerberg Hospital. Secondary objective: To assess if there is a difference in readability between therapeutic areas, as well as a difference in readability over two time periods. Methods: The readability of 84 ICFs given to patients at TREAD Research between the years 2000 and 2009 was quantitatively assessed by means of the Flesch–Kincaid Reading Ease, Flesch–Kincaid Grade Level, and Gunning-Fog index. Results: The mean ± standard deviation (SD) Flesch–Kincaid Reading Ease score for the 84 ICFs was 46.60 ± 5.62 (range 33.2–65.6). The mean ± SD grade level was 12.13 ± 1.8 (range 8.3–14.9) using the Flesch–Kincaid formula and 13.96 ± 1.22 (range 10.3–16.6) using the Gunning-Fog index. Readability at grade level 8 was only found in 1.2% of all the ICFs assessed. No differences were found in readability between therapeutic areas or over the two time periods. Conclusions: The main finding is that these forms are too complex to be understood by average study participants and their families.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2010-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S13608","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sodium nitroprusside-associated cyanide toxicity in adult patients – fact or fiction? A critical review of the evidence and clinical relevance","authors":"P. Abraham","doi":"10.2147/OAJCT.S7573","DOIUrl":"https://doi.org/10.2147/OAJCT.S7573","url":null,"abstract":"Correspondence: Prasad Abraham Department of Pharmacy and Drug information, Box 2061, Grady Health System, 80 Jesse Hill Jr Dr Se, Atlanta, GA 30303, USA Tel +1 404-616-3246 Fax +1 404-616-2228 email pabraham@gmh.edu Abstract: Since its US Food and Drug Administration (FDA) approval in 1974, sodium nitroprusside (SNP) has been fraught with controversy in regards to its safety. Over the years, a growing concern related to SNPs propensity to cause cyanide (CN) toxicity culminated into a series of case reports that led the FDA to develop a black-box warning with dose limitations of ,2 μg/kg/min. These recommendations stemmed also from the reality of the difficulty of obtaining CN levels in a timely manner, as well as the presumed poor correlation of metabolic markers (lactate levels and pH) as it related to the severity of CN toxicity. All these issues have driven practitioners to the use of alternative agents. In this paper, we critically review the cases and the data that led to the development of these restrictive dosing recommendations and reveal several limitations of the data and assumptions that led to these recommendations. We conclude that SNP is still a reasonable agent to use in the management of patients with hypertension today and can safely be used beyond doses of 2 μg/kg/min. Furthermore, in lieu of CN levels, monitoring of lactic acid levels is also a reasonable measure to ensure safety.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2010-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S7573","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68415656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Time will tell: community acceptability of HIV vaccine research before and after the \"Step Study\" vaccine discontinuation.","authors":"Paula M Frew,&nbsp;Mark J Mulligan,&nbsp;Su-I Hou,&nbsp;Kayshin Chan,&nbsp;Carlos del Rio","doi":"10.2147/OAJCT.S11915","DOIUrl":"https://doi.org/10.2147/OAJCT.S11915","url":null,"abstract":"<p><p>OBJECTIVE: This study examines whether men-who-have-sex-with-men (MSM) and transgender (TG) persons' attitudes, beliefs, and risk perceptions toward human immunodeficiency virus (HIV) vaccine research have been altered as a result of the negative findings from a phase 2B HIV vaccine study. DESIGN: We conducted a cross-sectional survey among MSM and TG persons (N = 176) recruited from community settings in Atlanta from 2007 to 2008. The first group was recruited during an active phase 2B HIV vaccine trial in which a candidate vaccine was being evaluated (the \"Step Study\"), and the second group was recruited after product futility was widely reported in the media. METHODS: Descriptive statistics, t tests, and chi-square tests were conducted to ascertain differences between the groups, and ordinal logistic regressions examined the influences of the above-mentioned factors on a critical outcome, future HIV vaccine study participation. The ordinal regression outcomes evaluated the influences on disinclination, neutrality, and inclination to study participation. RESULTS: Behavioral outcomes such as future recruitment, event attendance, study promotion, and community mobilization did not reveal any differences in participants' intentions between the groups. However, we observed greater interest in HIV vaccine study screening (t = 1.07, P < 0.05) and enrollment (t = 1.15, P < 0.05) following negative vaccine findings. Means on perceptions, attitudes, and beliefs did not differ between the groups. Before this development, only beliefs exhibited a strong relationship on the enrollment intention (β = 2.166, P = 0.002). However, the effect disappeared following negative trial results, with the positive assessment of the study-site perceptions being the only significant contributing factor on enrollment intentions (β = 1.369, P = 0.011). CONCLUSION: Findings show greater enrollment intention among this population in the wake of negative efficacy findings from the Step Study. The resolve of this community to find an HIV vaccine is evident. Moreover, any exposure to information disseminated in the public arena did not appear to negatively influence the potential for future participation in HIV vaccine studies among this population. The results suggest that subsequent studies testing candidate vaccines could be conducted in this population.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2010-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/OAJCT.S11915","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29531180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}