Pub Date : 2023-08-17DOI: 10.18203/2349-3259.ijct20232501
Sunil S. Iyer, Rajat Singal, Sandip Mitra, Muneeb Ahsan, Paridhi Mathur, Rakesh Jain
Background: Individuals with major depressive disorder (MDD) commonly present with comorbid anxiety and have greater depressive illness severity and chronicity, more suicide attempts, and completions. This randomized, double blind, double dummy, parallel-group clinical phase IV trial (CTRI/2022/11/047050) is aimed to compare the safety and efficacy of Placida® (FDC of flupentixol 0.5 mg + melitracen 10 mg) versus escitalopram + clonazepam in patients with comorbid anxiety and depression. Methods: This is a randomized, controlled, double blind, double dummy, parallel-group, phase IV trial. A total of 440 patients was enrolled across 11 sites in India who fulfilled the inclusion and exclusion criteria. All the subjects will be followed up for 2, 4, 6, 8, 10, 12, 16, 20, and 24 weeks with a buffer period of 1 week in each visit. The patient will be checked for severity of adverse events (AEs) and serious adverse events (SAEs). Efficacy will be assessed using the Hamilton depression rating scale (HAM-D), Hamilton anxiety rating scale (HAM-A) at baseline, weeks 4, 8 and 16, 24 score-reduction rate from baseline to end of treatment and extrapyramidal symptom rating scale (ESRS) at week 16 and end of the study. The first enrolment was done on 26 November 2022 and presently the subjects are under follow-up stage. The anticipated completion date for the study is March 2024. Conclusions: Outcomes of this trial will provide valuable information on safety and efficacy of Placida® as compared to escitalopram and clonazepam in treating patients with comorbid anxiety and depression. Trial Registration: The trial is registered with clinical trial registry India (CTRI/2022/11/047050) prospectively.
{"title":"Safety and efficacy of Placida® (fixed dose combination of flupentixol 0.5 mg and melitracen 10 mg) in comparison to escitalopram 10 mg and clonazepam 0.5 mg in patients with comorbid anxiety and depression: a randomized, double blind, double dummy, parallel group clinical trial","authors":"Sunil S. Iyer, Rajat Singal, Sandip Mitra, Muneeb Ahsan, Paridhi Mathur, Rakesh Jain","doi":"10.18203/2349-3259.ijct20232501","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232501","url":null,"abstract":"Background: Individuals with major depressive disorder (MDD) commonly present with comorbid anxiety and have greater depressive illness severity and chronicity, more suicide attempts, and completions. This randomized, double blind, double dummy, parallel-group clinical phase IV trial (CTRI/2022/11/047050) is aimed to compare the safety and efficacy of Placida® (FDC of flupentixol 0.5 mg + melitracen 10 mg) versus escitalopram + clonazepam in patients with comorbid anxiety and depression. Methods: This is a randomized, controlled, double blind, double dummy, parallel-group, phase IV trial. A total of 440 patients was enrolled across 11 sites in India who fulfilled the inclusion and exclusion criteria. All the subjects will be followed up for 2, 4, 6, 8, 10, 12, 16, 20, and 24 weeks with a buffer period of 1 week in each visit. The patient will be checked for severity of adverse events (AEs) and serious adverse events (SAEs). Efficacy will be assessed using the Hamilton depression rating scale (HAM-D), Hamilton anxiety rating scale (HAM-A) at baseline, weeks 4, 8 and 16, 24 score-reduction rate from baseline to end of treatment and extrapyramidal symptom rating scale (ESRS) at week 16 and end of the study. The first enrolment was done on 26 November 2022 and presently the subjects are under follow-up stage. The anticipated completion date for the study is March 2024. Conclusions: Outcomes of this trial will provide valuable information on safety and efficacy of Placida® as compared to escitalopram and clonazepam in treating patients with comorbid anxiety and depression. Trial Registration: The trial is registered with clinical trial registry India (CTRI/2022/11/047050) prospectively.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"62 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136215313","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 : 2023-07-26DOI: 10.18203/2349-3259.ijct20232200
R. K. Jinjwaria
The Rajendra Jinjwaria quality of life-22 (RJQOL-22) scale will help assess the overall quality of life in various acute and chronic diseases such as rheumatoid arthritis, osteo arthritis, and other conditions that affect the quality of life such as cardiovascular, HIV, and cancer. The tool was developed from 29 January 2019 to 01 May 2023 by Rajendra Kumar Jinjwaria at King George's Medical University Lucknow and Banaras Hindu University, Uttar Pradesh, India. The validity of the RJQOL-22 scale was established as per the content validity index (CVI) 98% and validated by more than 100 expert faculty across the world. The scale is standardized and highly valid for assessing the quality of life in acute and chronic diseases. The overall reliability of the scale based on a study was estimated to be (>0.983) through (Cronbach’s alpha value) and it indicates a highly reliable scale. While the individual reliability of group I and group II was 0.989 and 0.978 respectively. The acceptable cut-off value of coefficients was 0.7 for moderate and 0.8 for high reliability. This indicates that the tool used in the studies was highly reliable.
{"title":"Rajendra Jinjwaria quality of life-22 scale (RJQOL-22) scale","authors":"R. K. Jinjwaria","doi":"10.18203/2349-3259.ijct20232200","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232200","url":null,"abstract":"The Rajendra Jinjwaria quality of life-22 (RJQOL-22) scale will help assess the overall quality of life in various acute and chronic diseases such as rheumatoid arthritis, osteo arthritis, and other conditions that affect the quality of life such as cardiovascular, HIV, and cancer. The tool was developed from 29 January 2019 to 01 May 2023 by Rajendra Kumar Jinjwaria at King George's Medical University Lucknow and Banaras Hindu University, Uttar Pradesh, India. The validity of the RJQOL-22 scale was established as per the content validity index (CVI) 98% and validated by more than 100 expert faculty across the world. The scale is standardized and highly valid for assessing the quality of life in acute and chronic diseases. The overall reliability of the scale based on a study was estimated to be (>0.983) through (Cronbach’s alpha value) and it indicates a highly reliable scale. While the individual reliability of group I and group II was 0.989 and 0.978 respectively. The acceptable cut-off value of coefficients was 0.7 for moderate and 0.8 for high reliability. This indicates that the tool used in the studies was highly reliable.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"96 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76665392","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 : 2023-07-26DOI: 10.18203/2349-3259.ijct20232203
K. Vassis, I. Maliousis, S. Spanos, I. A. Poulis
The use of the internet for surveys and research is becoming increasingly widespread, including in observational research, which employs questionnaires and surveys to study various characteristics in patients, professionals, and institutions in biomedical and primary care research
{"title":"Improving the quality of Greek web surveys: adaptation of the checklist for reporting results of internet e-surveys in Greek language","authors":"K. Vassis, I. Maliousis, S. Spanos, I. A. Poulis","doi":"10.18203/2349-3259.ijct20232203","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232203","url":null,"abstract":"The use of the internet for surveys and research is becoming increasingly widespread, including in observational research, which employs questionnaires and surveys to study various characteristics in patients, professionals, and institutions in biomedical and primary care research","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88020544","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 : 2023-07-26DOI: 10.18203/2349-3259.ijct20232192
M. Bengtström, N. Tamminen, Niina Laaksonen, S. Pakkala, A. Juppo
Background: Clinical trials have been reported to cause medication cost avoidance (MCA) for hospitals and societies, but there are no studies documenting MCA from the Nordic countries or from the pharmaceutical industry perspective. Methods: Three different methods were tested for determining the yearly MCA in clinical trials conducted by the pharmaceutical industry in Finland. MCA was evaluated with questionnaires to pharmaceutical companies operating in Finland in 2001, 2009 and 2013. Results: In method 1 (year 2001), the MCA in Finland was 70.3 million euros in wholesale price and 50.9 million euros when excluding patients receiving placebo treatment. In method 2 (2009), the MCA was 52.0 million euros in wholesale price and 71.0 million euros in out-sale price i.e. including pharmacy fee and tax. The MCA in method 3 (2013) was 47.2 million euros in wholesale price. The collection of data and the MCA calculation was simple in method 1 (response rate 100%). The methods 2 and 3 were more precise but more time-consuming for the respondents, somewhat affecting the response rate (response rates 90% and 72%, respectively). Conclusions: All three methods covered the majority of industry-sponsored clinical medicine trials (64-100%) representing 59-63 % of all clinical trials conducted in Finland in those years. Regardless of the methods, the study medications provided by the pharmaceutical industry promoted significant cost saving for the society. We recommend method 1 for a general and less time consuming MCA calculation and method 3 for a more precise calculation, to be conducted in survey format and interview.
{"title":"The value of clinical trial medication and yearly medicine cost avoidance from clinical trials conducted by the pharmaceutical industry in Finland","authors":"M. Bengtström, N. Tamminen, Niina Laaksonen, S. Pakkala, A. Juppo","doi":"10.18203/2349-3259.ijct20232192","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232192","url":null,"abstract":"Background: Clinical trials have been reported to cause medication cost avoidance (MCA) for hospitals and societies, but there are no studies documenting MCA from the Nordic countries or from the pharmaceutical industry perspective.\u0000Methods: Three different methods were tested for determining the yearly MCA in clinical trials conducted by the pharmaceutical industry in Finland. MCA was evaluated with questionnaires to pharmaceutical companies operating in Finland in 2001, 2009 and 2013.\u0000Results: In method 1 (year 2001), the MCA in Finland was 70.3 million euros in wholesale price and 50.9 million euros when excluding patients receiving placebo treatment. In method 2 (2009), the MCA was 52.0 million euros in wholesale price and 71.0 million euros in out-sale price i.e. including pharmacy fee and tax. The MCA in method 3 (2013) was 47.2 million euros in wholesale price. The collection of data and the MCA calculation was simple in method 1 (response rate 100%). The methods 2 and 3 were more precise but more time-consuming for the respondents, somewhat affecting the response rate (response rates 90% and 72%, respectively).\u0000Conclusions: All three methods covered the majority of industry-sponsored clinical medicine trials (64-100%) representing 59-63 % of all clinical trials conducted in Finland in those years. Regardless of the methods, the study medications provided by the pharmaceutical industry promoted significant cost saving for the society. We recommend method 1 for a general and less time consuming MCA calculation and method 3 for a more precise calculation, to be conducted in survey format and interview.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90475337","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 : 2023-07-26DOI: 10.18203/2349-3259.ijct20232193
R. K. Jinjwaria
Background: Evaluate the effectiveness of hydrotherapy versus land-based exercise outcomes to decrease pain and improve the quality of life among patients with rheumatoid arthritis. Methods: Triple-blind, randomized controlled, parallel-group, multiple arm trial was conducted between 29/09/2019 to 30/09/2021 at the Department of PMR, KG University Lucknow India and randomization was done through the SNSOE. Eligible 90 patients suffering from rheumatoid arthritis. The intervention (RJHLERA) was administered in both study groups. NRPS used for pain and RJQOL-22 Scale was used for QoL. Results: The pre-test results showed all the subject’s average pain scores and quality of life had either poor or neither poor nor good levels of the RJQOL-22 scale. At the post-test, in terms of pain, the hydrotherapy exercise group showed the maximum response with an average pain score of 3.64±1.89, the land-based exercises group showed the next to maximum response with an average pain score of 5.88±1.37 while the control group showed the least response with an average pain score of 7.63±1.41. and in terms of quality of life, the hydrotherapy exercise group showed the maximum response with 67.9% very good, and 21.4% good. The land-based exercises group showed the next to maximum response with 19.2% good while the group the clear control group showed the least response. Conclusions: Effectiveness of hydrotherapy versus land-based exercises, in comparison to land-based exercises the Hydrotherapy exercises group showed the maximum response to reduce the pain and improve the quality of life among chronic rheumatoid arthritis patients.
{"title":"Evaluate the effectiveness of hydrotherapy versus land-based exercises outcome on pain and quality of life among patients with rheumatoid arthritis: triple-blind randomized controlled trial","authors":"R. K. Jinjwaria","doi":"10.18203/2349-3259.ijct20232193","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232193","url":null,"abstract":"Background: Evaluate the effectiveness of hydrotherapy versus land-based exercise outcomes to decrease pain and improve the quality of life among patients with rheumatoid arthritis.\u0000Methods: Triple-blind, randomized controlled, parallel-group, multiple arm trial was conducted between 29/09/2019 to 30/09/2021 at the Department of PMR, KG University Lucknow India and randomization was done through the SNSOE. Eligible 90 patients suffering from rheumatoid arthritis. The intervention (RJHLERA) was administered in both study groups. NRPS used for pain and RJQOL-22 Scale was used for QoL.\u0000Results: The pre-test results showed all the subject’s average pain scores and quality of life had either poor or neither poor nor good levels of the RJQOL-22 scale. At the post-test, in terms of pain, the hydrotherapy exercise group showed the maximum response with an average pain score of 3.64±1.89, the land-based exercises group showed the next to maximum response with an average pain score of 5.88±1.37 while the control group showed the least response with an average pain score of 7.63±1.41. and in terms of quality of life, the hydrotherapy exercise group showed the maximum response with 67.9% very good, and 21.4% good. The land-based exercises group showed the next to maximum response with 19.2% good while the group the clear control group showed the least response.\u0000Conclusions: Effectiveness of hydrotherapy versus land-based exercises, in comparison to land-based exercises the Hydrotherapy exercises group showed the maximum response to reduce the pain and improve the quality of life among chronic rheumatoid arthritis patients.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"48 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81780302","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 : 2023-07-26DOI: 10.18203/2349-3259.ijct20232191
Yuanyuan Lu, Wen Wang, Yangxin Huang, Henian Chen
Background: The hazard ratio has been widely used as an index of effect size in clinical trials for time-to-event data. The use of the Cox proportional hazards models and other hazard centered models is ubiquitous in clinical trials for time-to-event data. The relativity of effect sizes (small, medium, large) has been widely discussed and accepted when comparing magnitude of association for continuous and categorical data, but not yet for time-to-event outcomes. Methods: We review published hazard ratios, investigate the relationships among HR, relative risk (RR), odds ratio (OR), and Cohen’s d, and calculate the corresponding HRs for given event rate in control group ( ) by adding standard normal deviation with 0.2 (small), 0.5 (medium) and 0.8 (large) to the event rate in the case group ( based on equation . Results: Our results indicate that HRs are from 1.68 to 1.16 when the event rate of control group moves from 1% to 90%, which are equivalent to Cohen’s d = 0.2 (small). HRs are ranged between 3.43 and 1.43 when the event rate of control group moves from 1% to 90%, which are equivalent to Cohen’s d = 0.5 (medium), HRs are valued between 6.52 and 1.73 when the event rate of control group moves from 1% to 90%, which are equivalent to Cohen’s d = 0.8 (large). Conclusions: This study provides general guidelines in interpreting the magnitudes of HRs for time-to-event data in clinical trials.
背景:在临床试验中，风险比被广泛用作衡量事件时间数据效应大小的指标。Cox比例风险模型和其他以风险为中心的模型在临床试验中普遍用于事件时间数据。在比较连续数据和分类数据的关联程度时，效应大小(小、中、大)的相关性已被广泛讨论和接受，但在时间到事件结果方面尚未得到广泛讨论和接受。方法:我们回顾已发表的风险比，探讨HR、相对风险(RR)、优势比(OR)和Cohen’s d之间的关系，并通过在病例组的事件发生率中加入0.2(小)、0.5(中)和0.8(大)的标准正态偏差，计算出对照组()给定事件发生率的相应HR()。我们的结果表明，当对照组的事件率从1%移动到90%时，hr从1.68到1.16，相当于Cohen的d = 0.2(小)。当对照组事件率为1% ~ 90%时，hr介于3.43 ~ 1.43之间，相当于Cohen’s d = 0.5(中);当对照组事件率为1% ~ 90%时，hr介于6.52 ~ 1.73之间，相当于Cohen’s d = 0.8(大)。结论:本研究提供了解释临床试验中事件时间数据hr大小的一般指南。
{"title":"How big is a big hazard ratio in clinical trials?","authors":"Yuanyuan Lu, Wen Wang, Yangxin Huang, Henian Chen","doi":"10.18203/2349-3259.ijct20232191","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232191","url":null,"abstract":"Background: The hazard ratio has been widely used as an index of effect size in clinical trials for time-to-event data. The use of the Cox proportional hazards models and other hazard centered models is ubiquitous in clinical trials for time-to-event data. The relativity of effect sizes (small, medium, large) has been widely discussed and accepted when comparing magnitude of association for continuous and categorical data, but not yet for time-to-event outcomes.\u0000Methods: We review published hazard ratios, investigate the relationships among HR, relative risk (RR), odds ratio (OR), and Cohen’s d, and calculate the corresponding HRs for given event rate in control group ( ) by adding standard normal deviation with 0.2 (small), 0.5 (medium) and 0.8 (large) to the event rate in the case group ( based on equation .\u0000Results: Our results indicate that HRs are from 1.68 to 1.16 when the event rate of control group moves from 1% to 90%, which are equivalent to Cohen’s d = 0.2 (small). HRs are ranged between 3.43 and 1.43 when the event rate of control group moves from 1% to 90%, which are equivalent to Cohen’s d = 0.5 (medium), HRs are valued between 6.52 and 1.73 when the event rate of control group moves from 1% to 90%, which are equivalent to Cohen’s d = 0.8 (large).\u0000Conclusions: This study provides general guidelines in interpreting the magnitudes of HRs for time-to-event data in clinical trials.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"63 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80784039","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 : 2023-07-26DOI: 10.18203/2349-3259.ijct20232197
S. Vijayan, T. Babu, Arti Gupta, V. Reddy, D. Ramamohan
Background: Mistreatment of women during pregnancy and childbirth by healthcare workers is a common issue in both private and public sector health facilities in India. Improving the quality of maternity care in these sectors is crucial for promoting institutional births and ensuring positive birth experiences. This study aims to develop guidelines for respectful maternity care (RMC) in India through a multiphase quantitative and qualitative study. Methods: The study will utilize a mixed methods multiphase design, which involves collecting, analyzing, and integrating both quantitative and qualitative data. This approach follows the principles of pragmatism paradigm, where the integration of different approaches enhances understanding. The quantitative data will be used to expand and explain the qualitative data collected in the first phase. The integration of both types of data will contribute to the development of new RMC guidelines. Conclusions: This study is the first of its kind in India to develop comprehensive RMC guidelines based on a multiphase study. By exploring the experiences of Indian women regarding disrespect and abuse (D&A) during childbirth and its determinants, the study will provide valuable insights for guideline development. The integration of quantitative and qualitative approaches in the mixed method design will address potential limitations and provide a more comprehensive understanding of the subject.
{"title":"Identifying predictive factors and developing evidence-based guidelines for promoting respectful maternal and newborn care: a mixed method multiphase study design","authors":"S. Vijayan, T. Babu, Arti Gupta, V. Reddy, D. Ramamohan","doi":"10.18203/2349-3259.ijct20232197","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232197","url":null,"abstract":"Background: Mistreatment of women during pregnancy and childbirth by healthcare workers is a common issue in both private and public sector health facilities in India. Improving the quality of maternity care in these sectors is crucial for promoting institutional births and ensuring positive birth experiences. This study aims to develop guidelines for respectful maternity care (RMC) in India through a multiphase quantitative and qualitative study.\u0000Methods: The study will utilize a mixed methods multiphase design, which involves collecting, analyzing, and integrating both quantitative and qualitative data. This approach follows the principles of pragmatism paradigm, where the integration of different approaches enhances understanding. The quantitative data will be used to expand and explain the qualitative data collected in the first phase. The integration of both types of data will contribute to the development of new RMC guidelines.\u0000Conclusions: This study is the first of its kind in India to develop comprehensive RMC guidelines based on a multiphase study. By exploring the experiences of Indian women regarding disrespect and abuse (D&A) during childbirth and its determinants, the study will provide valuable insights for guideline development. The integration of quantitative and qualitative approaches in the mixed method design will address potential limitations and provide a more comprehensive understanding of the subject.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"121 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79442513","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 : 2023-07-26DOI: 10.18203/2349-3259.ijct20232194
Sharanabasappa ., K. Mathur, Shivakanth M. Sangapur, B. Meena
Background: The incidence of AKI in cardiac ICU is attributed mainly to Heart Failure and Acute Coronary Syndrome. AKI occurs commonly in the setting of AHF, and is termed CRS type 1. Biomarkers and bioelectrical impedance analysis can be helpful in estimating the real volume overload and may be useful to predict and avoid AKI. The role of UF remains controversial, and it is currently recommended only for diuretic-resistant patients. Objective of current study was to study demographic & clinical profile and outcome of patients with AKI in intensive coronary care unit. Methods: This prospective study was conducted in ICCU of R.N.T. Medical College, Udaipur. All the patients with increase in serum creatinine >50% were included in the study. Detailed investigations like urinary analysis, renal function tests (blood urea, serum creatinine, serum electrolytes), USG whole abdomen, 12 lead ECG, Echocardiography and Troponin T. Results: Among cases 56.67% had ADHF, 25% had MI, 10% had structural heart disease, 3.3% had systemic illness, 1.67% had cardiogenic shock, 1.67% were cardiac surgery associated and 1.67% had other causes of AKI. 30.0% of cases required ionotropic support while 2.5% of controls required ionotropic support. 5.0% of cases required ventilator support & renal replacement therapy while none of the controls required these. Conclusions: Patients with AKI had worse outcomes when compared to non-AKI. Mortality among cases was significantly higher than controls, 10% among cases versus only 2.5% in controls.
{"title":"Epidemiology, clinical profile and outcome of acute kidney injury in intensive coronary care unit","authors":"Sharanabasappa ., K. Mathur, Shivakanth M. Sangapur, B. Meena","doi":"10.18203/2349-3259.ijct20232194","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232194","url":null,"abstract":"Background: The incidence of AKI in cardiac ICU is attributed mainly to Heart Failure and Acute Coronary Syndrome. AKI occurs commonly in the setting of AHF, and is termed CRS type 1. Biomarkers and bioelectrical impedance analysis can be helpful in estimating the real volume overload and may be useful to predict and avoid AKI. The role of UF remains controversial, and it is currently recommended only for diuretic-resistant patients. Objective of current study was to study demographic & clinical profile and outcome of patients with AKI in intensive coronary care unit.\u0000Methods: This prospective study was conducted in ICCU of R.N.T. Medical College, Udaipur. All the patients with increase in serum creatinine >50% were included in the study. Detailed investigations like urinary analysis, renal function tests (blood urea, serum creatinine, serum electrolytes), USG whole abdomen, 12 lead ECG, Echocardiography and Troponin T.\u0000Results: Among cases 56.67% had ADHF, 25% had MI, 10% had structural heart disease, 3.3% had systemic illness, 1.67% had cardiogenic shock, 1.67% were cardiac surgery associated and 1.67% had other causes of AKI. 30.0% of cases required ionotropic support while 2.5% of controls required ionotropic support. 5.0% of cases required ventilator support & renal replacement therapy while none of the controls required these.\u0000Conclusions: Patients with AKI had worse outcomes when compared to non-AKI. Mortality among cases was significantly higher than controls, 10% among cases versus only 2.5% in controls.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79464832","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 : 2023-07-26DOI: 10.18203/2349-3259.ijct20232195
J. Muñoz-Padros, M. Garolera, A. Bartes, S. Anderson, Fabian Contreras-Briñez, Sonia Jimenez-Fuentes, Yemila Plana-Alcaide, Q. Foguet-Boreu
Background: Alzheimer's disease (AD) has a significant impact on the quality of life (QOL) and interventions aimed at their improvement show inconclusive results. Objectives were study protocol to evaluate the effectiveness of a multicomponent caregiver intervention on the QOL of persons with AD. Methods: The design is a randomized clinical trial with blinded assessment of response variables. Ninety-four dyads of informal caregivers and their relatives with AD will be recruited in the Osona and Ripollès territorial service of geriatrics and palliative care of the Consorci Hospitalari de Vic (Osona, Spain) and randomized into experimental (EG) and control group (CG). An 8-week online multicomponent psychological intervention including psychoeducation and mindfulness will be provided to the EG caregivers. The CG will perform the usual care. Outcome will be the QOL of persons with AD assessed with the QOL-AD. Conclusions: The multicomponent online caregiver research detailed in this protocol could be incorporated into health and care facilities for persons with AD and their families to improve caregiving and QOL.
{"title":"Effectiveness of online psychological intervention for caregivers on the quality of life of people with Alzheimer disease: a randomized clinical trial protocol","authors":"J. Muñoz-Padros, M. Garolera, A. Bartes, S. Anderson, Fabian Contreras-Briñez, Sonia Jimenez-Fuentes, Yemila Plana-Alcaide, Q. Foguet-Boreu","doi":"10.18203/2349-3259.ijct20232195","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232195","url":null,"abstract":"Background: Alzheimer's disease (AD) has a significant impact on the quality of life (QOL) and interventions aimed at their improvement show inconclusive results. Objectives were study protocol to evaluate the effectiveness of a multicomponent caregiver intervention on the QOL of persons with AD.\u0000Methods: The design is a randomized clinical trial with blinded assessment of response variables. Ninety-four dyads of informal caregivers and their relatives with AD will be recruited in the Osona and Ripollès territorial service of geriatrics and palliative care of the Consorci Hospitalari de Vic (Osona, Spain) and randomized into experimental (EG) and control group (CG). An 8-week online multicomponent psychological intervention including psychoeducation and mindfulness will be provided to the EG caregivers. The CG will perform the usual care. Outcome will be the QOL of persons with AD assessed with the QOL-AD.\u0000Conclusions: The multicomponent online caregiver research detailed in this protocol could be incorporated into health and care facilities for persons with AD and their families to improve caregiving and QOL.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74258932","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 : 2023-07-26DOI: 10.18203/2349-3259.ijct20232196
H. Kumar, Suksham Jain, Supreet Khurana, D. Chawla
Background: Neonatal resuscitation is a critical process for a newborn with effective ventilation as its key component. Three manual ventilation devices, including self-inflating bags (SIB), flow-inflating bags (FIB), and T-piece resuscitator (TPR) are recommended for positive pressure ventilation (PPV) in the delivery room. To date, there is insufficient evidence regarding the optimal device for establishing effective ventilation in newborns. This study is planned to compare the effectiveness of TPR and SIB during resuscitation. Methods: This will be a single centre, open-label, randomized controlled trial. Study participants will be preterm ≤34 of gestation needing PPV at birth as per NRP algorithm. Newborns will be randomly assigned to two groups (TPR or SIB). SpO2 at 2 and 5 min, time to reach heart rate >100/min by pulse oximetry, and duration of PPV will be recorded. Primary outcome is need of delivery room intubation. Intention to treat analysis will be done using STATA version 17.0. A priori defined subgroup for purpose of analysis will be gestation ≤30 and 31-34 weeks. Trial will be done as per good clinical practice guidelines. Conclusions: If PPV with TPR is proven to be more efficacious in terms of less delivery room intubation, there would be a way towards finalizing the TPR as primary device for providing PPV during delivery room resuscitation at birth. This study has potential to bring down need of delivery room intubation with less duration of mechanical ventilation and morbidity in form of IVH, BPD and composite outcome of BPD and death. Trial registration: CTRI number: CTRI/2023/01/048660.
{"title":"Protocol of randomized controlled trial comparing T piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonates","authors":"H. Kumar, Suksham Jain, Supreet Khurana, D. Chawla","doi":"10.18203/2349-3259.ijct20232196","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232196","url":null,"abstract":"Background: Neonatal resuscitation is a critical process for a newborn with effective ventilation as its key component. Three manual ventilation devices, including self-inflating bags (SIB), flow-inflating bags (FIB), and T-piece resuscitator (TPR) are recommended for positive pressure ventilation (PPV) in the delivery room. To date, there is insufficient evidence regarding the optimal device for establishing effective ventilation in newborns. This study is planned to compare the effectiveness of TPR and SIB during resuscitation.\u0000Methods: This will be a single centre, open-label, randomized controlled trial. Study participants will be preterm ≤34 of gestation needing PPV at birth as per NRP algorithm. Newborns will be randomly assigned to two groups (TPR or SIB). SpO2 at 2 and 5 min, time to reach heart rate >100/min by pulse oximetry, and duration of PPV will be recorded. Primary outcome is need of delivery room intubation. Intention to treat analysis will be done using STATA version 17.0. A priori defined subgroup for purpose of analysis will be gestation ≤30 and 31-34 weeks. Trial will be done as per good clinical practice guidelines.\u0000Conclusions: If PPV with TPR is proven to be more efficacious in terms of less delivery room intubation, there would be a way towards finalizing the TPR as primary device for providing PPV during delivery room resuscitation at birth. This study has potential to bring down need of delivery room intubation with less duration of mechanical ventilation and morbidity in form of IVH, BPD and composite outcome of BPD and death.\u0000Trial registration: CTRI number: CTRI/2023/01/048660.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"221 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89135351","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}
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