Journal of clinical trials最新文献

{"title":"Research Progress and Challenges to Coronavirus Vaccine Development","authors":"M. David","doi":"10.35248/2167-0870.20.S8.E001","DOIUrl":"https://doi.org/10.35248/2167-0870.20.S8.E001","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"12 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77082164","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":"Rationale and Design of a Spanish Mulicenter Randomized Controlled Trial of Use of Preoperative Levosimendan to Reduce Low Cardiac Output Syndrome (LCOS) in Low Ejection Fraction (andle; 35%) Cardiac Surgery Patients Spanish Randomized Clinical Trial on Sindax (Spartans Study)","authors":"M. Á. Tena, Luis Santana, S. Urso, J. González, Dolores Fiuza, M. Barbeito, F. Paredes, F. Portela","doi":"10.35248/2167-0870.10.7.440","DOIUrl":"https://doi.org/10.35248/2167-0870.10.7.440","url":null,"abstract":"Background: Low Cardiac Output Syndrome (LCOS) is a complication that appears in approximately 20%of cardiac surgeries with extracorporeal circulation. This is associated with increased mortality, delayed recovery and prolonged hospital stay. The Spanish Randomized Clinical Trial on Sindax (SPARTANS) aims to demonstrate the effectiveness of the preoperative use of levosimendan in reducing LCOS in patients with poor Left Ventricle Ejection Fraction (LVEF) undergoing elective cardiac surgery. Methods: SPARTANS study is a multicenter, randomized triple-blind, placebo-controlled trial. 300 patients with LVEF ≤ 35%, undergoing elective cardiac surgery will be recruited from 9 Spanish hospitals and randomized into two groups: Preoperative administration of levosimendan or placebo for 24 hours. The study drug will be started as a continuous infusion (0.1 μg/kg/ min) at least 8 hours before surgery. The primary endpoint will be 30-day LCOS. It will be evaluated using any of the following criteria: 1) Postoperated cardiac index ≤ 2.0 L/min/m2, 2) Need to implant a intra-aortic balloon pump/left ventricular assist device, 3) Vasoactive inotropic scale (VIS) >5.5. The secondary end-point will be composite event rate at one year including the following events: death from any cause, need for renal replacement therapy or dialysis and LCOS. The sample size is based on the assumption that levosimendan reduces LCOS by 50%. Conclusion: The effectiveness of levosimendan has not yet been reported with a good evidence in cardiac surgery. We will test the hypothesis that levosimendan reduces LCOS in patients with compromised left ventricular function. Trial registration number: NCT04179604 (ClinicalTrials.gov). Rationale and Design of a Spanish Mulicenter Randomized Controlled Trial of Use of Preoperative Levosimendan to Reduce Low Cardiac Output Syndrome (LCOS) in Low Ejection Fraction (≤ 35%) Cardiac Surgery Patients Spanish Randomized Clinical Trial on Sindax (Spartans Study)","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"57 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73866266","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":"Neuroaesthetics of Art Vision: An Experimental Approach to the Sense of Beauty","authors":"Mazzacane Sante, C. Maddalena, Caselli Elisabetta, Lanzoni Luca, Volta Antonella, Bisi Matteo, Cesari Silvia, Vivarelli Arianna, Balboni Pier Giorgio, S. Giuseppe, Avanzini Pietro, Vecchiato Giovanni, F. Maddalena, Sironi Vittorio Aless, ro, Portera Mariagrazia, Gatti Andrea, Domenicali Filippo, Folgieri Raffaella, Banzi Annalisa, Sassu Giovanni, Salvinelli Fabrizio","doi":"10.35248/2167-0870.20.10.404","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.404","url":null,"abstract":"Objective: NEVArt research aims to study the correlation between a set of neurophysiological/emotional reactions and the level of aesthetic appreciation of around 500 experimental subjects, during the observation of 18 different paintings from the XVI-XVIII century, in a real museum context. Methods: Several bio-signals have been recorded to evaluate the participants’ reactions during the observation of paintings. Among them: (a) neurovegetative, motor and emotional biosignals were recorded using wearable tools for EEG (electroencephalogram), ECG (electrocardiogram) and EDA (electrodermal activity); (b) gaze pattern during the observation of art works, while (c) data of the participants (age, gender, education, familiarity with art, etc.) and their explicit judgments about paintings have been obtained. Participants were invited to respond during the observation of paintings, reporting the degree of pleasantness, perceived movement and familiarity with the painted subject. Results: Each recorded bio-signal will be correlated with the explicit evaluations obtained by participants during the museum experience. These results may contribute to enlarge the theoretical framework on the physiological, cognitive and emotional responses of people when viewing pictorial artworks. Conclusion: The NEVArt research, both in term of technical skills and upgrade in neuroscientific awareness, can be the basis to proceed with a set of further research topics in the near future. Ground-breaking and statistically significant observations can be derived from the present research, mainly at the biological, medical and didactical point of view, by paving the way for many other multidisciplinary research developments on art exhibit, architecture, etc.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"8 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79465919","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":"Erythrocyte Sedimentation Rate and C-Reactive Protein are Markers for Tumor Aggressiveness and Survival in Patients with Hepatocellular Carcinoma","authors":"B. Carr, H. Akkız, Guerra, R. Donghia, K. Yalcin, Ümit Karaoğullarından, E. Altıntaş, A. Özakyol, H. Şimşek, Balaban Hy, A. Balkan, A. Uyanıkoğlu, N. Ekin","doi":"10.35248/2167-0870.20.10.428","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.428","url":null,"abstract":"Introduction: Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) are acute phase reactants in clinical use for monitoring inflammatory diseases for several decades. CRP is also prognostically useful in several cancers. Objective: To evaluate the role of ESR as a possible indicator of tumor biology and survival in patients with hepatocellular carcinoma (HCC). Methods: A large cohort of HCC patients in Turkey was examined retrospectively for clinical and tumor characteristics with respect to blood CRP and ESR levels. Results: Portal vein thrombosis and high Aggressiveness Index were significantly related to elevated CRP or ESR levels and especially to the combination of elevated CRP and ESR, both in the total cohort and in patients with small tumors <5cm. A final logistic regression model of an Aggressiveness Index score gave an Odds Ratio of 10.37 for the ESR and CRP combination, compared to the reference category. Furthermore, a Cox regression model on death gave a Hazard Ratio of 2.53 for the ESR and CRP combination versus the reference category for each of them (p<0.001). A significant Hazard Ratio for the ESR and CRP combination was also found for patients with low alpha-fetoprotein. Conclusions: ESR is a useful biomarker for HCC extent and survival, especially in combination with CRP, in patients with small or large tumors and with elevated or low serum alpha-fetoprotein.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"7 1","pages":"1-11"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80195748","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":"Possible Anti-Diabetic and Anti-Hyperlipidemic Efficacy of Blended Rice Bran Oil with Sesame Oil in Comparison with Soybean Oil: A Clinical Investigation in Pre-Diabetic and Diabetic Individuals","authors":"D. Hota, An, Srinivasan, J. Sahoo, Kishore Behera, B. Patro, B. Debapriya, Yopadhyay, R. Sehgal","doi":"10.35248/2167-0870.20.10.419","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.419","url":null,"abstract":"Objective: Cooking oil is an important ingredient of the diet and type of cooking oil used can affect the incidence and progression of metabolic disorders. It is established that mono and polyunsaturated fatty acids lowers the risk of diabetes or helps in better management of diabetes. The blend of rice bran oil and sesame oil contains PUFA and MUFA in nearly recommended levels. The present study was planned to evaluate and validate effect of blend of Rice BranOil and Sesame Oil (RBSO) in subjects with type II diabetes. Research design and methods: Fifty one diabetic patients were randomized to receive either Fortune vivo blended rice-bran oil (RBSO; n=26) or the comparator soybean oil (n=25). RBSO was given to 29 non-diabetic, 28 pre-diabetic controls. The amount of cooking oils was given for the entire family as per the recommended daily dietary requirement for 12 weeks. Following 12 weeks of study and a subsequent wash-out period of 21 days, 12 patients were randomly selected from each arm of the 2 diabetic patient groups and were crossed over to receive the other study oil and evaluated every 4 weeks for another 12 weeks in a similar manner as before. Results: There was reduction in FBS and PPBS across all RBSO groups, but was significant only in the diabetic patients (p=0.010). There was no significant change in FBS or PPBS levels observed in soybean oil treated group. RBSO treated diabetic group showed 9.5% reduction of HbA1c while it was elevated in the soybean oil group. Both RBSO and soybean oil were well tolerated by all subjects and no adverse event was noted in any study group. Conclusion: In the present study, RBSO appeared to improve sugar metabolism as evidenced by reduction in FBS, PPBS and HbA1c in type-2 diabetic patients.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"36 5 1","pages":"1-10"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77964930","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":"Prognostic Value of Risk Assessment Tools for Patients with Pulmonary Arterial Hypertension in WHO Functional Class II: A Post Hoc Analysis of the EARLY Trial","authors":"N. Kim, Cass, R. Lickert, J. Pruett, Carol Zhao, W. Drake","doi":"10.35248/2167-0870.10.7.443","DOIUrl":"https://doi.org/10.35248/2167-0870.10.7.443","url":null,"abstract":"Background: Current practice guidelines for patients with Pulmonary Arterial Hypertension (PAH) recommend a multidimensional risk assessment, but World Health Organization (WHO) Functional Class (FC) remains a main criterion for treatment decisions. Objectives: A post hoc analysis was conducted to determine if different risk assessment tools evaluated in PAH registry populations can identify patients in WHO FC II at higher risk of death. Methods: Patients in the randomized, controlled EARLY trial (NCT00091715; N=185), which exclusively enrolled patients in FC II, were stratified into three categories—low-, intermediate-, and high-risk—using the original REVEAL risk calculator, revised REVEAL risk calculator 2.0, COMPERA categorical score, and two FPHN methods (invasive and non-invasive) counting low-risk criteria. Risk of all-cause death was compared between baseline categories. Associations between change in risk category from baseline to month 6 (improved, worsened, or stable) and PAH worsening or death were estimated using a Cox proportional hazards model, adjusting for baseline risk category. Results: Patients classified as intermediate or high risk ranged from 35% using the original REVEAL risk calculator to 89% by the COMPERA method at baseline, and from 37% to 82%, respectively, at month 6. Higher risk category was associated with increased mortality risk. Rates of subsequent PAH worsening and death were higher in patients with worsened risk category and lower in those with improved risk category. Conclusion: Multiparametric assessment has additional prognostic value over FC alone, but different risk assessment tools vary in risk stratification. PAH patients in WHO FC II are not all at low risk, so should be assessed frequently.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"1 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90107649","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 South East Asia Multi-Country Survey Assessing Awareness and Preparedness of the Clinical Investigation Staff on Risk Based Monitoring (RBM) Approach","authors":"K. Kumar, M. Jadhav","doi":"10.35248/2167-0870.20.10.413","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.413","url":null,"abstract":"Background: Patient safety being paramount, the global agencies (US-FDA, EMA, MHRA, ICH) have developed various guidance to improve clinical trials quality, conduct, performance and assess these on risk based principles. Among these, Risk Based Monitoring (RBM) has gained a considerable traction globally to be implemented across all phases of clinical trials. Methods: A multi-type survey questionnaire containing 19 elements was developed, validated, and circulated among clinical trial staff, between July 2016-June 2017. The survey consisted questions pertaining to responder’s sex, role, trial experience in past 5 years, utilization of RBM tools, type of trials involved in RBM, opinion on better type of monitoring, timely oversight of trial data by RBM, implications of RBM in subject’s safety, data quality, overall efficiency, cost specifications, understanding of RBM methodologies and its future evaluation, readiness to adopt RBM and anticipating challenges in RBM strategies. The survey responses were collected, compiled and entries were verified by third party, and analyzed. Results: Overall 502 responses were received from 3 countries selected i.e. India (n=282), Malaysia (n=207) and Singapore (n=13); all responses were complete except one. In the survey, 260 (51.79%) males and 242 (48.21%) females participated. Among the responders 114 (28.69%) were investigators, 153(30.48%) were coordinator/research nurse, 134 (26.69%) were CRO personnel and 71 (14.14%) were other clinical staffs. 208 (80%) male participants and 181 (74.79%) female participants were aware about RBM awareness and it was proportionate with number of years of clinical trials experience. Overall, RBM awareness among the responders was 77.49% (n=389). Among the two groups i.e. responses received from Malaysia+Singapore (MS) and India, awareness rate among Investigators MS was 47.88% (n=34) and in India was 65.75% (n=48), among coordinator/research nurse it was 63.95% (n=55) and 85.07% (n=57), among CRO personnel it was 95.24% (n=40) and 95.65% (n=88) and with other clinical staffs it was 90.48% (n=19) and 96% (n=48) respectively. The awareness rate among investigators and coordinator/research nurse was significantly varied between two groups (p<0.03 and p<0.003) respectively. When asked if you will be ready to adopt the RBM concept, 60.45%% (n=133) from MS and 76.59% (n=216) of the participants from India agreed to adopt, 26.36% (n=58) and 12.05% (n=34) were neutral and 10.45% (n=23) and 7.09% (n=20) were not sure about it.Additionally, 77% of the responders agreed on adopting hybrid monitoring (onsite+ remote) approach and if embraced by sponsors this new approach of RBM can improve the trial conduct and minimize the risks. Chi’s Square or Fisher’s exact test used to analysis the significance between twogroups, the significance rate of p<0.001 was determined for demographics, trials involved in past 5 years, trials involve RBM, cost management via RBM, and anticipating cha","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"146 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85328129","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":"Developing an Effective Training Curriculum for Cell and Gene Therapy Operational Teams","authors":"Chris A. Learn, Tracy D. Stewart, Monica R. Shah","doi":"10.35248/2167-0870.20.10.432","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.432","url":null,"abstract":"Cell And Gene Therapies (CAGT) have become a market force across a continuum of therapeutic indications. The CAGT market value is expected to reach nearly $7 billion USD by 2027 with a cost-adjusted growth rate of nearly 20% according to leading market research indices. Given their complexity, scope and breadth, it is essential to effectively educate and train resources to perform the required CAGT clinical trial operational delivery functions, as the quality and integrity of this form of therapy directly impacts patient safety. Described herein are empirical data, experiences and best practices for establishing a CAGT training curriculum to help achieve clinical trial operational competencies, protocol compliance and better patient outcomes.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"57 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88258301","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":"Efficacy of Mobile Phone Short Message Service (SMS) Reminders on Malaria Treatment Adherence and Day 3 Post-Treatment Reviews (SMS-RES-MAL) in Kenya: A Study Protocol.","authors":"Ambrose O Talisuna,&nbsp;Dejan Zurovac,&nbsp;Sophie Githinji,&nbsp;Amos Oburu,&nbsp;Josephine Malinga,&nbsp;Andrew Nyandigisi,&nbsp;Caroline Oh Jones,&nbsp;Robert W Snow","doi":"10.4172/2167-0870.1000217","DOIUrl":"https://doi.org/10.4172/2167-0870.1000217","url":null,"abstract":"<p><strong>Background: </strong>Mobile phone short messaging services (SMS) have been investigated in health information reporting, provider performance, drug and diagnostic stock management and patient adherence to treatment for chronic diseases. However, their potential role in improving patients' adherence to malaria treatment and day 3 post treatment reviews remains unclear.</p><p><strong>Methods/design: </strong>A \"proof of concept\" open label randomised controlled trial will be conducted at four sites in Western Kenya. Principal research questions are: 1) Can mobile phone SMS reminders improve patient adherence to malaria treatment? 2) Can mobile phone SMS reminders improve day 3 post treatment reviews? Eligible caregivers (n=1000 per arm) of children under five years old with uncomplicated malaria will be randomly assigned (one to one) to: a) the current standard of care (provider counselling and health education); and b) the current standard of care plus SMS reminders. Within each arm, caregivers will be further randomized to three different categories. In categories 1 and 2, 300 caregivers per arm per category will be visited at home on day 1 and 2 of follow up respectively, to measure appropriate timing and adherence of the second Artemether-Lumefantrine (AL) dose and doses 3 and 4. Further, caregivers in categories 1 and 2 will be required to come to the health facility for the day 3 post treatment reviews. Finally, in category 3, 400 caregivers per arm will be visited at home on day 3 to measure adherence for the full AL course. Each category will be visited at home only once to avoid biases in the measures of adherence as a result of home consultations. Primary outcomes will be adherence to the full AL course (category 3), as well as, the proportion of patients reporting back for day 3 post treatment reviews (categories 1 and 2). The primary analysis will be intention-to-treat. Costs of the intervention will be measured over the period of the intervention, and a cost-effectiveness ratio will be estimated.</p><p><strong>Discussion: </strong>If successful, evidence from this trial could improve malaria treatment adherence and offer pragmatic approaches for antimalarial drug resistance surveillance and risk mitigation in Africa.</p><p><strong>Current controlled trials: </strong>ISRCTN39512726.</p>","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"5 2","pages":"217"},"PeriodicalIF":0.0,"publicationDate":"2019-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4172/2167-0870.1000217","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37405169","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":"Effects on Patients Home Care by Telephone Follow-up after Hospital Discharge: Study Protocol of a Randomized Controlled Trial","authors":"Tsukasa Domoto, Y. Matsumura, Midori Fukada","doi":"10.4172/2167-0870.1000360","DOIUrl":"https://doi.org/10.4172/2167-0870.1000360","url":null,"abstract":"Objective: To investigate patients’ post-discharge difficulties through periodic telephone follow-ups from the hospital nurse to the care manager.Methods: The effects of the intervention will be examined using a randomized controlled trial and prospective randomized, open blinded-endpoint evaluation. This research targets patients who are older than 65 years of age, require a care manager and leave the hospital for their homes or residential care facilities. The participants, 50 pairs of patients and care managers, will provide consent for this study. In the intervention group, telephone follow ups from the hospital nurse to the care manager will be carried out three times: one week, one month, and two months after discharge; the control group will follow standard protocols. A self-administered questionnaire survey about difficulties after discharge will be conducted twice (one week and two months after discharge), and the results will be compared between groups. In addition, 10 care managers from the intervention group will be interviewed, and the contents will be analyzed as a process evaluation.Discussion: The novelty of this study is that it strengthens the cooperation between the staff using telephone follow-ups and the evaluates the patients’ unease and frustration. If effective, the telephone follow-up could be systematized and incorporated into standard care. Furthermore, the appropriate period, timing, and frequency of telephone follow-ups may become clear with the study. In terms of future research, the development of a new follow up program based on the results of this study and the examination of its effects will contribute to the development of the follow-up system.Trial registration: This study was registered with the UMIN Clinical Trials Registry on May 7, 2018 (ID: UMIN000032251).","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"302 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2019-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89041334","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}