Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.425
B. Carr, H. Akkız, H. Bag, Guerra, R. Donghia, K. Yalcin, Ümit Karaoğullarından, E. Altntaş, A. Özakyol, H. Şimşek, Balaban Hy, A. Balkan, A. Uyankoglu, N. Ekin
Introduction: Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) are acute phase reactants and gamma-glutamyl transpeptidase (GGT) is a liver enzyme that is associated with prognosis in patients with hepatocellular carcinoma (HCC). Objective: To evaluate the value of ESR and GGT singly and together in HCC prognosis and as predictors of tumor aggressiveness parameters. Methods: The database from a large cohort of Turkish HCC patients was examined retrospectively for the prognostic usefulness of blood ESR and GGT levels and the associated patient subgroup characteristics. Results: Patients with low vs. high blood ESR or GGT values had greater than double survival, with hazard ratios (HR) by Cox regression of 1.543 and 1.833 respectively. The combination of ESR plus GGT was associated with a 3- fold survival difference and an HR of 2.410. Patients with high vs. low ESR plus GGT levels had significantly greater maximum tumor diameters, alpha-fetoprotein levels, multifocality and percent of patients with portal vein thrombosis. Significant survival differences were also found for patients with low serum alpha-fetoprotein levels. Addition of CRP levels to the ESR plus GGT combination added further discriminant survival information, but for greater computational complexity. Conclusions: ESR plus GGT is a useful and powerful prognosticator in HCC patients, including those with low alpha-fetoprotein levels and significantly associates with all the tumor parameters of HCC patients.
{"title":"Erythrocyte Sedimentation Rate and Gamma-glutamyl Transpeptidase Combined are Potent Predictors of Survival and Tumor Characteristics inHepatocellular Carcinoma Patients","authors":"B. Carr, H. Akkız, H. Bag, Guerra, R. Donghia, K. Yalcin, Ümit Karaoğullarından, E. Altntaş, A. Özakyol, H. Şimşek, Balaban Hy, A. Balkan, A. Uyankoglu, N. Ekin","doi":"10.35248/2167-0870.20.10.425","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.425","url":null,"abstract":"Introduction: Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) are acute phase reactants and gamma-glutamyl transpeptidase (GGT) is a liver enzyme that is associated with prognosis in patients with hepatocellular carcinoma (HCC). Objective: To evaluate the value of ESR and GGT singly and together in HCC prognosis and as predictors of tumor aggressiveness parameters. Methods: The database from a large cohort of Turkish HCC patients was examined retrospectively for the prognostic usefulness of blood ESR and GGT levels and the associated patient subgroup characteristics. Results: Patients with low vs. high blood ESR or GGT values had greater than double survival, with hazard ratios (HR) by Cox regression of 1.543 and 1.833 respectively. The combination of ESR plus GGT was associated with a 3- fold survival difference and an HR of 2.410. Patients with high vs. low ESR plus GGT levels had significantly greater maximum tumor diameters, alpha-fetoprotein levels, multifocality and percent of patients with portal vein thrombosis. Significant survival differences were also found for patients with low serum alpha-fetoprotein levels. Addition of CRP levels to the ESR plus GGT combination added further discriminant survival information, but for greater computational complexity. Conclusions: ESR plus GGT is a useful and powerful prognosticator in HCC patients, including those with low alpha-fetoprotein levels and significantly associates with all the tumor parameters of HCC patients.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"204 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":"76023339","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}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.S3.002
F. Trémolières
{"title":"The Sinking of Clinical Trials! How Wrong done by a Virus could have Undermine Rigor and Compromises Response to Emergency","authors":"F. Trémolières","doi":"10.35248/2167-0870.20.S3.002","DOIUrl":"https://doi.org/10.35248/2167-0870.20.S3.002","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"146 1","pages":"2-3"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77683847","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}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.395
Abdulaziz Qobty, Saad Alqarni, S. Alnami, R. Traad, R. Shaker, Shahad Almutiri, M. Alhayan, Njood Alnahdi, Nadia Alhariri
Background: Total Thyroidectomy is common procedure among patients with thyroid disorders including malignancies, thyrotoxicosis, multi-nodular goiter and chronic thyroiditis. There are many complications that recorded after this procedure which is more related to surgeon experience and nature of disorder. Among these disorders, hematoma, recurrent laryngeal nerve injury and hypocalcaemia are the most frequent. Modern thyroidectomy is focused on the mortality of surgery by preventing damage to adjacent structures, such as parathyroid glands and recurrent laryngeal nerve. Aim of the study: To assess the clinical presentation and post-operative complications among total thyroidectomy cases in Aseer Central Hospital [ACH]. Methodology: A retrospective record based descriptive approach was used through reviewing medical records of all cases that underwent total thyroidectomy for different indications in Aseer Central Hospital [ACH] during the period from 2000 to 2019. Data extracted throng pre-structured questionnaire including patient's bio-clinical data, preoperative symptoms and complications of the procedure. Results: The study included 150 cases. One hundred and thirteen cases [75.3%] aged above 40 years. The main compliant recorded for the cases was neck swelling which was recorded among 56% of the cases followed with dysphagia. About 91% of the cases recorded post-operative complications. Scar was the most recorded complication followed with hypocalcaemia. Conclusion and recommendations: In conclusion, the study revealed that neck swelling was the most recorded clinical finding with dysphagia. Majority of cases recorded post-operative complications mainly scar and hypocalcaemia.
{"title":"Epdimiology and Complications of Total Thyroidctomy in Aseer Central Hospital","authors":"Abdulaziz Qobty, Saad Alqarni, S. Alnami, R. Traad, R. Shaker, Shahad Almutiri, M. Alhayan, Njood Alnahdi, Nadia Alhariri","doi":"10.35248/2167-0870.20.10.395","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.395","url":null,"abstract":"Background: Total Thyroidectomy is common procedure among patients with thyroid disorders including malignancies, thyrotoxicosis, multi-nodular goiter and chronic thyroiditis. There are many complications that recorded after this procedure which is more related to surgeon experience and nature of disorder. Among these disorders, hematoma, recurrent laryngeal nerve injury and hypocalcaemia are the most frequent. Modern thyroidectomy is focused on the mortality of surgery by preventing damage to adjacent structures, such as parathyroid glands and recurrent laryngeal nerve. Aim of the study: To assess the clinical presentation and post-operative complications among total thyroidectomy cases in Aseer Central Hospital [ACH]. Methodology: A retrospective record based descriptive approach was used through reviewing medical records of all cases that underwent total thyroidectomy for different indications in Aseer Central Hospital [ACH] during the period from 2000 to 2019. Data extracted throng pre-structured questionnaire including patient's bio-clinical data, preoperative symptoms and complications of the procedure. Results: The study included 150 cases. One hundred and thirteen cases [75.3%] aged above 40 years. The main compliant recorded for the cases was neck swelling which was recorded among 56% of the cases followed with dysphagia. About 91% of the cases recorded post-operative complications. Scar was the most recorded complication followed with hypocalcaemia. Conclusion and recommendations: In conclusion, the study revealed that neck swelling was the most recorded clinical finding with dysphagia. Majority of cases recorded post-operative complications mainly scar and hypocalcaemia.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"77 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":"83922433","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}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.E410
M. Schlund
We take extreme pleasure to uphold that Journal of Clinical Trials had a promising journey since its inception and is being hailed as a revolutionary in the industry of open access journals. We appreciatively give thanks to all our marvelous Authors, Reviewers, teamed with the assistance of our honorable Editorial board members has played a major role in our success for creating Clinical Trails 2019 the simplest ever!
{"title":"Current Challenges in Clinical Trials","authors":"M. Schlund","doi":"10.35248/2167-0870.20.10.E410","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.E410","url":null,"abstract":"We take extreme pleasure to uphold that Journal of Clinical Trials had a promising journey since its inception and is being hailed as a revolutionary in the industry of open access journals. We appreciatively give thanks to all our marvelous Authors, Reviewers, teamed with the assistance of our honorable Editorial board members has played a major role in our success for creating Clinical Trails 2019 the simplest ever!","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"148 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77850931","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}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.402
Wail Alkashkari, Saad Albugami, Mohammed W Althobaiti, Mawaddah Alfouti, J. Alrahimi, A. Kinsara, Atif Alzahrani, J. Fern, Ez, Adel Tash, Hayam Aburemish
Aortic coarctation (CoA) is not uncommon congenital cardiac disease. Surgical repair of native CoA is nowadays a common and safe procedure at early childhood. However, late complications, including re-CoA and aneurysm formation, are not uncommon. The incidence of these complications is dependent on the type of the initial operation. Both transcatheter and surgical repair play important roles in the treatment of late surgical complications. This article will review the incidence of late complications after CoA repair and will discuss the transcatheter treatment options for such complications in the view of recent advancement in transcatheter therapy.
{"title":"Transcatheter Intervention for Late Complications after Aortic Coarctation Surgical Repair","authors":"Wail Alkashkari, Saad Albugami, Mohammed W Althobaiti, Mawaddah Alfouti, J. Alrahimi, A. Kinsara, Atif Alzahrani, J. Fern, Ez, Adel Tash, Hayam Aburemish","doi":"10.35248/2167-0870.20.10.402","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.402","url":null,"abstract":"Aortic coarctation (CoA) is not uncommon congenital cardiac disease. Surgical repair of native CoA is nowadays a common and safe procedure at early childhood. However, late complications, including re-CoA and aneurysm formation, are not uncommon. The incidence of these complications is dependent on the type of the initial operation. Both transcatheter and surgical repair play important roles in the treatment of late surgical complications. This article will review the incidence of late complications after CoA repair and will discuss the transcatheter treatment options for such complications in the view of recent advancement in transcatheter therapy.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"42 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81644750","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}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.408
Saud M. Elsaughier, M. Salama, A. Hanafy, M. Ahmed, A. Ibrahim
Background: HF biomarkers have growing importance in daily clinical practice as well as in clinical trials. Several biomarkers are used for diagnosis and prognosis of HF patients. Recently, Galectine-3 has been proposed for diagnosis and prognosis of HF. In this study we aimed to determine the relationship between galectine-3 level and cardiac functions in patients with chronic heart failure and its correlation with clinical manifestations. Methods: The current study enrolled 90 patients with chronic heart failure and then divided according to ejection fraction (EF) into two groups , group I included 60 patients with clinical manifestation of HF and EF 50%.serum levels of Galectine-3 were measured in all patients with heart failure. Results: Level of galectine-3 was significantly increasing with advancing in NYHA classes [p value <0.001), while it had insignificant negative correlation with ejection fraction (r=0.06; P=0.51) and the Level of galactin-3 was significantly increasing with advancing in diastolic dysfunction grade (P= <0.001) Conclusion: Plasma galectine-3 concentration can be used as a biomarker to aid in clinical staging and severity of heart failure.
{"title":"Assessment of the Relationship between Galectine-3 and Cardiac Functions in Patients with Chronic Heart Failure","authors":"Saud M. Elsaughier, M. Salama, A. Hanafy, M. Ahmed, A. Ibrahim","doi":"10.35248/2167-0870.20.10.408","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.408","url":null,"abstract":"Background: HF biomarkers have growing importance in daily clinical practice as well as in clinical trials. Several biomarkers are used for diagnosis and prognosis of HF patients. Recently, Galectine-3 has been proposed for diagnosis and prognosis of HF. In this study we aimed to determine the relationship between galectine-3 level and cardiac functions in patients with chronic heart failure and its correlation with clinical manifestations. Methods: The current study enrolled 90 patients with chronic heart failure and then divided according to ejection fraction (EF) into two groups , group I included 60 patients with clinical manifestation of HF and EF 50%.serum levels of Galectine-3 were measured in all patients with heart failure. Results: Level of galectine-3 was significantly increasing with advancing in NYHA classes [p value <0.001), while it had insignificant negative correlation with ejection fraction (r=0.06; P=0.51) and the Level of galactin-3 was significantly increasing with advancing in diastolic dysfunction grade (P= <0.001) Conclusion: Plasma galectine-3 concentration can be used as a biomarker to aid in clinical staging and severity of heart failure.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"41 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80224877","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}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.394
N. Garg
Background: Any treatment for unknown infertility is empiric by default, and the broad range of treatment, including expectant management, superovulation, IUI, IVF and IVF–intracytoplasmic sperm injection, reflects the uncertainty with this diagnosis. There are limited data to support the efficacy of many of these treatments, and no uniform protocol exists in clinical practice. Autologous platelet rich plasma (A-PRP) can be a novel technique which has never been explored before much in this field. Objective: To compare autologous platelet rich plasma with expectant management in cases of unexplained infertility. Materials and methods: All cases (50) of primary unexplained infertility were treated with either A-PRP or by expectant management on the basis of their endometrial thickness (7 mm). All cases of thin endometrium (<7 mm) were subjected to A-PRP (25 cases). Whereas rest of the cases (25 in number) was monitored as per expectant management protocol for a maximum of three cycles after which they were switched over to being treated with PRP. The main outcomes measured were number of follicles, endometrial thickness, pregnancy rate and miscarriage rates. The statistical analysis was evaluated with IBM SPSS Statistics for Windows, Version 24.0, IBM Corp, and Chicago, IL. Results: Out of 46 patients, 25 patients (54.35%) got conceived with a single dose of intra-uterine autologous platelet rich plasma injection, which was found to be statistically highly significant. The correlation analysis with Spearman’s Rank correlation coefficient (rho ρ) was 0.891 which show highly positive correlation between intrauterine autologous platelet rich plasma injection and pregnancy rate and 0.247 which show weakly positive correlation between expectant management and pregnancy rate. Conclusion: Autologous platelet rich plasma (A-PRP) is a novel technique than can treat unexplained infertility with favorable outcomes.
背景:对不明原因不孕症的任何治疗默认都是经验性的，广泛的治疗，包括期待治疗、超排卵、人工授精、体外受精和体外受精-卵胞浆内单精子注射，反映了这种诊断的不确定性。支持这些治疗方法有效性的数据有限，在临床实践中也没有统一的方案。自体富血小板血浆(a - prp)是一种新的技术，在这一领域从未被探索过。目的:比较自体富血小板血浆与保守治疗不明原因不孕症的疗效。材料和方法:所有原发不明原因不孕症患者(50例)均根据其子宫内膜厚度(7 mm)采用A-PRP或预期治疗。25例子宫内膜薄(<7 mm)均行A-PRP。而其余病例(25例)根据预期管理方案进行了最多三个周期的监测，之后他们切换到PRP治疗。主要观察指标为卵泡数、子宫内膜厚度、妊娠率和流产率。采用IBM SPSS Statistics for Windows, Version 24.0, IBM Corp, Chicago, IL进行统计学分析。结果:46例患者中，单剂量子宫内自体富血小板血浆注射成功怀孕25例(54.35%)，差异有统计学意义。相关分析与Spearman’s Rank相关系数(rho ρ)为0.891，表明宫内自体富血小板血浆注射与妊娠率呈高度正相关;相关系数为0.247，表明孕妇管理与妊娠率呈弱正相关。结论:自体富血小板血浆(a - prp)是一种治疗不明原因不孕症的新技术，疗效良好。
{"title":"Autologous Platelet Rich Plasma (A-PRP) in Unexplained Infertility: A Revolution in Reproductive Medicine","authors":"N. Garg","doi":"10.35248/2167-0870.20.10.394","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.394","url":null,"abstract":"Background: Any treatment for unknown infertility is empiric by default, and the broad range of treatment, including expectant management, superovulation, IUI, IVF and IVF–intracytoplasmic sperm injection, reflects the uncertainty with this diagnosis. There are limited data to support the efficacy of many of these treatments, and no uniform protocol exists in clinical practice. Autologous platelet rich plasma (A-PRP) can be a novel technique which has never been explored before much in this field. Objective: To compare autologous platelet rich plasma with expectant management in cases of unexplained infertility. Materials and methods: All cases (50) of primary unexplained infertility were treated with either A-PRP or by expectant management on the basis of their endometrial thickness (7 mm). All cases of thin endometrium (<7 mm) were subjected to A-PRP (25 cases). Whereas rest of the cases (25 in number) was monitored as per expectant management protocol for a maximum of three cycles after which they were switched over to being treated with PRP. The main outcomes measured were number of follicles, endometrial thickness, pregnancy rate and miscarriage rates. The statistical analysis was evaluated with IBM SPSS Statistics for Windows, Version 24.0, IBM Corp, and Chicago, IL. Results: Out of 46 patients, 25 patients (54.35%) got conceived with a single dose of intra-uterine autologous platelet rich plasma injection, which was found to be statistically highly significant. The correlation analysis with Spearman’s Rank correlation coefficient (rho ρ) was 0.891 which show highly positive correlation between intrauterine autologous platelet rich plasma injection and pregnancy rate and 0.247 which show weakly positive correlation between expectant management and pregnancy rate. Conclusion: Autologous platelet rich plasma (A-PRP) is a novel technique than can treat unexplained infertility with favorable outcomes.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"16 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":"74028173","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}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.412
Masaya Sato, Shin Suzuki, R. Tateishi, M. Kinoshita, Takuma Nakatsuka, T. Ogawa, R. Nakagawa, Kohta Satake, Y. Yatomi, K. Koike
Background and Aims: The incidences of end-stage liver disease and hepatocellular carcinoma arising from nonalcoholic steatohepatitis (NASH) are rapidly increasing. Although weight reduction is recommended as an initial treatment, no pharmacologic treatments for this condition are presently available. The aims of the current study were(1) to develop a smartphone application-based intervention for weight reduction in NASH patients, and (2) to evaluate the feasibility of using this application in daily clinical practice. Methods: We developed a mobile phone application for NASH patients (NASH App). We then prospectively enrolled 9 clinically diagnosed NASH patients and applied a 24-week intervention using the NASH App in addition to the usual follow-up with laboratory and imaging studies. The use of the NASH App by the patients and the changes in weight and biomarkers were evaluated after the 24-week intervention. Results: The mean patient age was 37.67 years, and 7 patients (77.78%) were male. The mean BMI was 29.63 kg/m2. Seven patients completed the counseling provided by the NASH App. Since one patient was lost to follow-up, the comparison between pre- and post-intervention values was performed for 8 patients. A post-intervention weight reduction was observed in 7 patients, and this weight reduction was statistically significant (p=0.02).Normalization of the ALT level (<30 U/L) was observed in two patients. Conclusion: The NASH App intervention for NASH patients is feasible and acceptable. Further studies using a control arm and a larger population are needed to confirm the efficacy of the NASH App.
{"title":"Effect of Smartphone Application-Enabled Daily Intervention for Patients with Nonalcoholic Steatohepatitis: A Feasibility Study","authors":"Masaya Sato, Shin Suzuki, R. Tateishi, M. Kinoshita, Takuma Nakatsuka, T. Ogawa, R. Nakagawa, Kohta Satake, Y. Yatomi, K. Koike","doi":"10.35248/2167-0870.20.10.412","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.412","url":null,"abstract":"Background and Aims: The incidences of end-stage liver disease and hepatocellular carcinoma arising from nonalcoholic steatohepatitis (NASH) are rapidly increasing. Although weight reduction is recommended as an initial treatment, no pharmacologic treatments for this condition are presently available. The aims of the current study were(1) to develop a smartphone application-based intervention for weight reduction in NASH patients, and (2) to evaluate the feasibility of using this application in daily clinical practice. Methods: We developed a mobile phone application for NASH patients (NASH App). We then prospectively enrolled 9 clinically diagnosed NASH patients and applied a 24-week intervention using the NASH App in addition to the usual follow-up with laboratory and imaging studies. The use of the NASH App by the patients and the changes in weight and biomarkers were evaluated after the 24-week intervention. Results: The mean patient age was 37.67 years, and 7 patients (77.78%) were male. The mean BMI was 29.63 kg/m2. Seven patients completed the counseling provided by the NASH App. Since one patient was lost to follow-up, the comparison between pre- and post-intervention values was performed for 8 patients. A post-intervention weight reduction was observed in 7 patients, and this weight reduction was statistically significant (p=0.02).Normalization of the ALT level (<30 U/L) was observed in two patients. Conclusion: The NASH App intervention for NASH patients is feasible and acceptable. Further studies using a control arm and a larger population are needed to confirm the efficacy of the NASH App.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"25 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":"82499596","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}
Pub Date : 2020-01-01DOI: 10.35248/2167-0870.20.10.E415
Abigail Mk
The current novel coronavirus disease 2019 (COVID-19) pandemic has led to substantial changes in health risks, access to health care, and daily interactions. Through these and other challenges, the pandemic is affecting ongoing clinical trials that are evaluating interventions aimed at preventing or treating diseases other than COVID-19. Meaningful alterations to the implementation of protocol-specified procedures for adherence and retention of study participants, without careful consideration of the consequences to statistical analysis, can compromise the generalizability of clinical trial results about efficacy and safety of studied interventions in the postpandemic setting [1].
{"title":"Clinical Trials during Covid-19","authors":"Abigail Mk","doi":"10.35248/2167-0870.20.10.E415","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.E415","url":null,"abstract":"The current novel coronavirus disease 2019 (COVID-19) pandemic has led to substantial changes in health risks, access to health care, and daily interactions. Through these and other challenges, the pandemic is affecting ongoing clinical trials that are evaluating interventions aimed at preventing or treating diseases other than COVID-19. Meaningful alterations to the implementation of protocol-specified procedures for adherence and retention of study participants, without careful consideration of the consequences to statistical analysis, can compromise the generalizability of clinical trial results about efficacy and safety of studied interventions in the postpandemic setting [1].","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"39 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":"82068420","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：