Pub Date : 2023-04-26DOI: 10.18203/2349-3259.ijct20231103
S. Biswas, B. Bal
Background: Probiotics are routinely prescribed to boost gut health and reduce severity of diarrhea. This study aimed to compare the efficacy and safety of Lactobacillus rhamnosus GG (LrGG) and Saccharomyces boulardii as an adjunct treatment for acute diarrhea in Indian children aged 6–36 months. Methods: In this single-center, open label, comparative, randomized controlled study, children were randomized into three groups (n=35, each) and provided either low osmolarity oral rehydration solution (ORS) and zinc (20 mg/day) alone or ORS+Zinc supplemented with one of the two probiotic preparations, LrGG ATCC 53103 or S. boulardii CNCM 1-745. Children were monitored every 8 hours after admission and the duration of diarrhea and hospital stay, and stool frequency were evaluated. Results: Of the total 105 children enrolled in the study, majority were aged between 13–24 months (40%). LrGG significantly reduced the mean duration of diarrhea by nearly 19 hours, when compared to the control group (p=0.003), while reduction by S. boulardii was not significant. The mean hospital stay duration for control group was about 6 days, which was significantly reduced (p=0.0001) by nearly 23 hours by LrGG, and non-significantly by S. boulardii. On day 2, LrGG significantly reduced stool frequency by 32.31%, as compared to 27.44% reduction in control group. S. boulardii reduced stool frequency by 31.76%, which was not statistically significant compared to that in control group. Conclusions: LrGG showed statistically significant reduction in duration of diarrhea and hospital stay, when compared against the group receiving ORS+zinc either alone or with S. boulardii.
{"title":"Comparative, randomized-controlled trial on efficacy and safety of Lactobacillus rhamnosus GG and Saccharomyces boulardii in treatment of acute diarrhea in Indian children (COMPARE-GG trial)","authors":"S. Biswas, B. Bal","doi":"10.18203/2349-3259.ijct20231103","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231103","url":null,"abstract":"Background: Probiotics are routinely prescribed to boost gut health and reduce severity of diarrhea. This study aimed to compare the efficacy and safety of Lactobacillus rhamnosus GG (LrGG) and Saccharomyces boulardii as an adjunct treatment for acute diarrhea in Indian children aged 6–36 months.\u0000Methods: In this single-center, open label, comparative, randomized controlled study, children were randomized into three groups (n=35, each) and provided either low osmolarity oral rehydration solution (ORS) and zinc (20 mg/day) alone or ORS+Zinc supplemented with one of the two probiotic preparations, LrGG ATCC 53103 or S. boulardii CNCM 1-745. Children were monitored every 8 hours after admission and the duration of diarrhea and hospital stay, and stool frequency were evaluated.\u0000Results: Of the total 105 children enrolled in the study, majority were aged between 13–24 months (40%). LrGG significantly reduced the mean duration of diarrhea by nearly 19 hours, when compared to the control group (p=0.003), while reduction by S. boulardii was not significant. The mean hospital stay duration for control group was about 6 days, which was significantly reduced (p=0.0001) by nearly 23 hours by LrGG, and non-significantly by S. boulardii. On day 2, LrGG significantly reduced stool frequency by 32.31%, as compared to 27.44% reduction in control group. S. boulardii reduced stool frequency by 31.76%, which was not statistically significant compared to that in control group.\u0000Conclusions: LrGG showed statistically significant reduction in duration of diarrhea and hospital stay, when compared against the group receiving ORS+zinc either alone or with S. boulardii.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"85 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79305874","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 : 2023-04-26DOI: 10.18203/2349-3259.ijct20231108
S. Bose, P. Basu, S. Sengupta, R. Mandal
Background: A system comprising of screening for pre-cancerous lesions succeeded by therapeutic interventions can greatly reduce the incidence of cervical cancer. High risk HPV detection in urine has proven itself as a potential primary screening tool. However, only a few studies have showed it’s concordance with matched self-collected vaginal samples while screening for high risk HPV infection in the community. Objective of the study was to determine the concordance between first void urine sample and self-collected vaginal sample for high risk HPV detection using Cobas 4800. The sensitivity and positive predictive value of screening by urine HPV testing for CIN 2+ detection would also be done along with its acceptability and cost analysis in community screening. Methods: This study will include women between 30-60 years with intact cervix and no precancerous lesions. Self-sampling will be provided by participants in the form of urine and vaginal swab collection by the Collipee device and vaginal swab stick respectively. This will be followed by high risk HPV testing using Cobas 4800 technology. The participants will also be asked to fill up a questionnaire about the acceptability of urine sampling for cancer screening. Conclusions: Screening tools can perhaps be diversified in order to suit the needs of low and middle income countries. Research and development of cervical cancer screening tools could hence bring to light feasible alternatives that could further improve compliance of non-attenders. Trial registration: The trial is registered with clinical trials registry (CTRI/2023/01/049322).
{"title":"Concordance between urine and self-collected vaginal samples for high-risk HPV detection in cervical cancer screening","authors":"S. Bose, P. Basu, S. Sengupta, R. Mandal","doi":"10.18203/2349-3259.ijct20231108","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231108","url":null,"abstract":"Background: A system comprising of screening for pre-cancerous lesions succeeded by therapeutic interventions can greatly reduce the incidence of cervical cancer. High risk HPV detection in urine has proven itself as a potential primary screening tool. However, only a few studies have showed it’s concordance with matched self-collected vaginal samples while screening for high risk HPV infection in the community. Objective of the study was to determine the concordance between first void urine sample and self-collected vaginal sample for high risk HPV detection using Cobas 4800. The sensitivity and positive predictive value of screening by urine HPV testing for CIN 2+ detection would also be done along with its acceptability and cost analysis in community screening.\u0000Methods: This study will include women between 30-60 years with intact cervix and no precancerous lesions. Self-sampling will be provided by participants in the form of urine and vaginal swab collection by the Collipee device and vaginal swab stick respectively. This will be followed by high risk HPV testing using Cobas 4800 technology. The participants will also be asked to fill up a questionnaire about the acceptability of urine sampling for cancer screening.\u0000Conclusions: Screening tools can perhaps be diversified in order to suit the needs of low and middle income countries. Research and development of cervical cancer screening tools could hence bring to light feasible alternatives that could further improve compliance of non-attenders.\u0000Trial registration: The trial is registered with clinical trials registry (CTRI/2023/01/049322).","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"58 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80171915","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 : 2023-04-11DOI: 10.18203/2349-3259.ijct20231028
S. Mahajan, Salil Garg, Richa Sharma, Yogendra Pratap Singh, Nitin Chandola, T. Bhatia, Basundhara Bansal
Background: Reliable and early detection of myocardial ischemia using computer-aided analysis of electrocardiograms (ECG) provides an important reference for early diagnosis of CVD. We developed a 12-lead smartphone-based electrocardiogram (ECG) acquisition and monitoring system (called “Spandan”), and an application to assess underlying ischemia from analysis of electrocardiographic (ECG) signals only. Objectives of this study were to validate the Spandan 12 lead ECG interpretation for accuracy in the detection of Ischemia in comparison to cardiologists’ diagnosis and to evaluate the accuracy of ischemia in comparison to the interpretation of standard 12 lead ECG. Methods: In this multi-center study all patients (n=597) visiting the ECG room at the department of cardiology were enrolled in the study by taking their written consent and explaining the purpose of the study. Results: Mean age was 52.85 years. The male gender (n=344, 57.62%) shows the maximum frequency than female gender. 12 lead Spandan smartphone ECG recorded fewer false positive cases (8 versus 230) and identified greater true negative cases (310 versus 115). Spandan smartphone ECG recorded better specificity (97.4% versus 33.3%) and positive predictive value (87.4% versus 51.4%) as compared to gold standard ECG. The accuracy of interpretation of Ischemia by cardiologists diagnosis through 12 lead Spandan smartphone ECG was better (100%) as compared gold standard (95.3%). Conclusions: Our study highlights the potential of Spandan smartphone ECG in the detection of myocardial ischemia. This may improve patient satisfaction and reduce healthcare costs.
{"title":"Validation of the detection of ischemia using 12 lead smartphone based electrocardiography - a non-randomized, single blinded, cross-sectional, multicenter study","authors":"S. Mahajan, Salil Garg, Richa Sharma, Yogendra Pratap Singh, Nitin Chandola, T. Bhatia, Basundhara Bansal","doi":"10.18203/2349-3259.ijct20231028","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231028","url":null,"abstract":"Background: Reliable and early detection of myocardial ischemia using computer-aided analysis of electrocardiograms (ECG) provides an important reference for early diagnosis of CVD. We developed a 12-lead smartphone-based electrocardiogram (ECG) acquisition and monitoring system (called “Spandan”), and an application to assess underlying ischemia from analysis of electrocardiographic (ECG) signals only. Objectives of this study were to validate the Spandan 12 lead ECG interpretation for accuracy in the detection of Ischemia in comparison to cardiologists’ diagnosis and to evaluate the accuracy of ischemia in comparison to the interpretation of standard 12 lead ECG.\u0000Methods: In this multi-center study all patients (n=597) visiting the ECG room at the department of cardiology were enrolled in the study by taking their written consent and explaining the purpose of the study.\u0000Results: Mean age was 52.85 years. The male gender (n=344, 57.62%) shows the maximum frequency than female gender. 12 lead Spandan smartphone ECG recorded fewer false positive cases (8 versus 230) and identified greater true negative cases (310 versus 115). Spandan smartphone ECG recorded better specificity (97.4% versus 33.3%) and positive predictive value (87.4% versus 51.4%) as compared to gold standard ECG. The accuracy of interpretation of Ischemia by cardiologists diagnosis through 12 lead Spandan smartphone ECG was better (100%) as compared gold standard (95.3%).\u0000Conclusions: Our study highlights the potential of Spandan smartphone ECG in the detection of myocardial ischemia. This may improve patient satisfaction and reduce healthcare costs.\u0000 ","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81220185","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 : 2023-03-23DOI: 10.18203/2349-3259.ijct20230700
Dimitra Katsantoni, A. Chalkia, Giorgos Tsigaras, Thomas Besios, Konstantinos Chandolias
The brain is a system with multidimensional organization and architecture and requires a continuous supply of blood in order to normally function. If blood flow is interrupted for more than a few seconds, the brain is deprived of blood and oxygen, causing death in nerve cells in the affected area. Stroke in children after birth appears even more rarely than in adults. For the study, 10 children with hemiplegic cerebral palsy (7 boys and 3 girls) participated (mean age 10, 9 years), from the “General Hospital Hippocratio” of Thessaloniki, according to the inclusion criteria. The strength of the upper extremity was measured using the Jamar dynamometer and for the assessment of the balance the pediatric balance scale (PBS) affected and contralateral hands, results were analyzed and compared with norms for age and sex and related to the affected balance. It was found that the strength of the non-affected upper extremities was also reduced according to the data of the normal children and the balance was also affected because of the stroke. Physiotherapy programs may include exercises that give emphasis on the non-affected upper extremities, more similar research must be done on a bigger population.
{"title":"Evaluation of the strength of the upper extremity in children with hemiplegia after stroke: a case series study","authors":"Dimitra Katsantoni, A. Chalkia, Giorgos Tsigaras, Thomas Besios, Konstantinos Chandolias","doi":"10.18203/2349-3259.ijct20230700","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20230700","url":null,"abstract":"The brain is a system with multidimensional organization and architecture and requires a continuous supply of blood in order to normally function. If blood flow is interrupted for more than a few seconds, the brain is deprived of blood and oxygen, causing death in nerve cells in the affected area. Stroke in children after birth appears even more rarely than in adults. For the study, 10 children with hemiplegic cerebral palsy (7 boys and 3 girls) participated (mean age 10, 9 years), from the “General Hospital Hippocratio” of Thessaloniki, according to the inclusion criteria. The strength of the upper extremity was measured using the Jamar dynamometer and for the assessment of the balance the pediatric balance scale (PBS) affected and contralateral hands, results were analyzed and compared with norms for age and sex and related to the affected balance. It was found that the strength of the non-affected upper extremities was also reduced according to the data of the normal children and the balance was also affected because of the stroke. Physiotherapy programs may include exercises that give emphasis on the non-affected upper extremities, more similar research must be done on a bigger population.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81538354","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 : 2023-02-18DOI: 10.18203/2349-3259.ijct20230350
S. Mahajan, Salil Garg, Richa Sharma, Yogendra Pratap Singh, N. Chandola, T. Bhatia, Basundhara Bansal
Background: In patients experiencing an ST-elevation myocardial infarction (STEMI), rapid diagnosis leads to optimal clinical outcomes. Recent technology has provided access to a reliable means of obtaining an ECG reading through a smartphone application (app) that works with an attachment providing all 12-leads of a standard ECG system. We developed a 12-lead smartphone-based electrocardiogram (ECG) called “Spandan”, and an application to accurately assess the presence of STEMI in patients presenting with chest pain. Objectives of study was to perform clinical observation studies on the patients screened for STEMIs and evaluate the variation in the diagnosis of STEMIs detected in both 12-lead gold standard and Spandan 12 lead ECG. Methods: This single-center study was carried out at Shri Mahant Indresh hospital (SMIH), Dehradun, Uttarakhand, India from April-2022 to November-2022. All patients (n=278) visiting the ECG room with symptoms of chest pain, shortness of breath and past history of cardiovascular disease at the department of cardiology of the SMIH, Dehradun were included in the study. Results: Mean age (SD) was 53.96±15.31 years. The male gender participants was 75.17%. 14.3% were STEMI patients as per the standard 12 lead interpretation, smartphone ECG interpreted 7.1% of the participants as STEMI and cardiologist interpreted nearly 15.4% of the participants of STEMI. Conclusions: This study confirmed the potential of a smartphone ECG for evaluation of STEMI and the feasibility of studying this technology further to define the diagnostic accuracy, limitations, and appropriate use of this new technology.
{"title":"Validation of interpretation of ST-elevation myocardial infarction using the smartphone based 12 lead electrocardiograms in comparison to the cardiologist-a cross sectional study, validation study, single-center study","authors":"S. Mahajan, Salil Garg, Richa Sharma, Yogendra Pratap Singh, N. Chandola, T. Bhatia, Basundhara Bansal","doi":"10.18203/2349-3259.ijct20230350","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20230350","url":null,"abstract":"Background: In patients experiencing an ST-elevation myocardial infarction (STEMI), rapid diagnosis leads to optimal clinical outcomes. Recent technology has provided access to a reliable means of obtaining an ECG reading through a smartphone application (app) that works with an attachment providing all 12-leads of a standard ECG system. We developed a 12-lead smartphone-based electrocardiogram (ECG) called “Spandan”, and an application to accurately assess the presence of STEMI in patients presenting with chest pain. Objectives of study was to perform clinical observation studies on the patients screened for STEMIs and evaluate the variation in the diagnosis of STEMIs detected in both 12-lead gold standard and Spandan 12 lead ECG.\u0000Methods: This single-center study was carried out at Shri Mahant Indresh hospital (SMIH), Dehradun, Uttarakhand, India from April-2022 to November-2022. All patients (n=278) visiting the ECG room with symptoms of chest pain, shortness of breath and past history of cardiovascular disease at the department of cardiology of the SMIH, Dehradun were included in the study.\u0000Results: Mean age (SD) was 53.96±15.31 years. The male gender participants was 75.17%. 14.3% were STEMI patients as per the standard 12 lead interpretation, smartphone ECG interpreted 7.1% of the participants as STEMI and cardiologist interpreted nearly 15.4% of the participants of STEMI.\u0000Conclusions: This study confirmed the potential of a smartphone ECG for evaluation of STEMI and the feasibility of studying this technology further to define the diagnostic accuracy, limitations, and appropriate use of this new technology.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79657026","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 : 2023-01-23DOI: 10.18203/2349-3259.ijct20230051
M. McVey, S. Saeed, R. Siddiqui, C. Armali, Amie T Kron, D. Branch, D. Brinc, Liying Zhang, N. Shehata, K. Pavenski, Akash Gupta, Yulia Lin, L. Lieberman, J. Pendergrast, J. Callum, C. Cserti-Gazdewich
Background: Cardiorespiratory transfusion reactions drive most transfusion-related morbidity and mortality. Transfusion-associated circulatory overload and transfusion-related acute lung injury have established causes, important impacts, mitigation options, and revised definitions, while non-conforming CRTRs fall into a category known as transfusion-associated dyspnea. Though procedures to investigate high-risk febrile transfusion reactions are typically rooted in detecting incompatibility or bacterial contamination, a common standard for examining CRTRs is lacking. CRTRs are further challenged by charting limitations, confounding (or enhanced susceptibility) by comorbidities, and/or overlapping insults. Deeper profiling of CRTRs could improve categorizations, reveal best-value diagnostics, and decipher the nature of (and/or minimize) reactions coded as TAD. Methods: The primary objective of this multi-center study is to reduce uncertainty in final conclusions drawn on CRTRs (cases), defined by dyspnea with objective disturbances and/or significant hemodynamic insults, with/without fever (±F). HRFTRs (controls) represent higher-grade F (T≥39°C or chills/rigors or lower-grade F (≥38°C by +Δ1°C) with non-respiratory effects). Patients (goal: 200) consent to additional sampling (≤24h post-TR) to identify contributing factors in case/control presentations, and in diagnostic groups (TRALI, TACO±F, TAD). Mechanistic axes of interest are cardiorenal, hemolytic, leukoagglutinating, biolipid, vasoactive, and inflammatory. Secondary goals include elucidation of real-life “insult-multiplicity” in CRTRs, tests of greatest yield, and distinguishing features in TRALI/TACO/TAD. Conclusions: A deep systematic CRTR probe may not only reduce diagnostic uncertainty but frame biomarker performance and pathologic signatures in definition-specific CRTRs. The re-classifiability or biology of TAD may be better understood. High-quality, mechanistic, true-to-quantity hemovigilance better exposes burdens and management options. Trial Registration: The trial is registered with ClinicalTrials.gov. with registry number NCT04267029.
{"title":"The transfusion-associated dyspnea prospective observation and laboratory assessment study: a protocol for investigating and disambiguating cardiopulmonary and high-grade febrile transfusion reactions in adults","authors":"M. McVey, S. Saeed, R. Siddiqui, C. Armali, Amie T Kron, D. Branch, D. Brinc, Liying Zhang, N. Shehata, K. Pavenski, Akash Gupta, Yulia Lin, L. Lieberman, J. Pendergrast, J. Callum, C. Cserti-Gazdewich","doi":"10.18203/2349-3259.ijct20230051","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20230051","url":null,"abstract":"Background: Cardiorespiratory transfusion reactions drive most transfusion-related morbidity and mortality. Transfusion-associated circulatory overload and transfusion-related acute lung injury have established causes, important impacts, mitigation options, and revised definitions, while non-conforming CRTRs fall into a category known as transfusion-associated dyspnea. Though procedures to investigate high-risk febrile transfusion reactions are typically rooted in detecting incompatibility or bacterial contamination, a common standard for examining CRTRs is lacking. CRTRs are further challenged by charting limitations, confounding (or enhanced susceptibility) by comorbidities, and/or overlapping insults. Deeper profiling of CRTRs could improve categorizations, reveal best-value diagnostics, and decipher the nature of (and/or minimize) reactions coded as TAD.\u0000Methods: The primary objective of this multi-center study is to reduce uncertainty in final conclusions drawn on CRTRs (cases), defined by dyspnea with objective disturbances and/or significant hemodynamic insults, with/without fever (±F). HRFTRs (controls) represent higher-grade F (T≥39°C or chills/rigors or lower-grade F (≥38°C by +Δ1°C) with non-respiratory effects). Patients (goal: 200) consent to additional sampling (≤24h post-TR) to identify contributing factors in case/control presentations, and in diagnostic groups (TRALI, TACO±F, TAD). Mechanistic axes of interest are cardiorenal, hemolytic, leukoagglutinating, biolipid, vasoactive, and inflammatory. Secondary goals include elucidation of real-life “insult-multiplicity” in CRTRs, tests of greatest yield, and distinguishing features in TRALI/TACO/TAD.\u0000Conclusions: A deep systematic CRTR probe may not only reduce diagnostic uncertainty but frame biomarker performance and pathologic signatures in definition-specific CRTRs. The re-classifiability or biology of TAD may be better understood. High-quality, mechanistic, true-to-quantity hemovigilance better exposes burdens and management options.\u0000Trial Registration: The trial is registered with ClinicalTrials.gov. with registry number NCT04267029.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82920877","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 : 2023-01-23DOI: 10.18203/2349-3259.ijct20230056
Deepika C., Jayalakshmy R., G. Roy, S. R.
Background: Road traffic injuries are the single biggest contributor of fatality among age 10 to 24 years worldwide. Also, there is no standardized education system for providing road safety education in schools. This study aims to check the effectiveness of teacher-led activity-based road safety educational intervention to the school children of age 11-15 years will improve their knowledge, attitude, self-reported practice and self-reported parent practice, compared to the existing curriculum and to find the feasibility, perception of children and teachers in implementing this intervention as a part of routine curriculum. Methods: This mixed-methods study has stratified cluster randomized trial as quantitative part and focused group discussions as qualitative part. This will be carried out in co-education English medium schools located in urban Puducherry. Study participants are school children of age 11-15 years in the class 7, 8 and 9 of the selected schools. The data will be collected using pre-tested semi-structured questionnaire. Assessments will be done at three time points in the intervention schools and at baseline and end-line in the control schools. The module for intervention will be developed by principal investigator and provided to the teachers after prior sensitization. Conclusions: This study protocol is designed to test the hypothesis that, the teacher-lead activity-based learning for school children will improve their road safety knowledge, practices and behavior compared to existing curriculum if any. Trial Registration: The trial is registered in Clinical Trials Registry, India (REF/2018/01/016902).
{"title":"Effect of teacher-led activity-based learning on road safety education among school children protocol for a mixed-methods study","authors":"Deepika C., Jayalakshmy R., G. Roy, S. R.","doi":"10.18203/2349-3259.ijct20230056","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20230056","url":null,"abstract":"Background: Road traffic injuries are the single biggest contributor of fatality among age 10 to 24 years worldwide. Also, there is no standardized education system for providing road safety education in schools. This study aims to check the effectiveness of teacher-led activity-based road safety educational intervention to the school children of age 11-15 years will improve their knowledge, attitude, self-reported practice and self-reported parent practice, compared to the existing curriculum and to find the feasibility, perception of children and teachers in implementing this intervention as a part of routine curriculum.\u0000Methods: This mixed-methods study has stratified cluster randomized trial as quantitative part and focused group discussions as qualitative part. This will be carried out in co-education English medium schools located in urban Puducherry. Study participants are school children of age 11-15 years in the class 7, 8 and 9 of the selected schools. The data will be collected using pre-tested semi-structured questionnaire. Assessments will be done at three time points in the intervention schools and at baseline and end-line in the control schools. The module for intervention will be developed by principal investigator and provided to the teachers after prior sensitization.\u0000Conclusions: This study protocol is designed to test the hypothesis that, the teacher-lead activity-based learning for school children will improve their road safety knowledge, practices and behavior compared to existing curriculum if any.\u0000Trial Registration: The trial is registered in Clinical Trials Registry, India (REF/2018/01/016902).","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88215824","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 : 2023-01-23DOI: 10.18203/2349-3259.ijct20230057
S. Milovanov
Mostly of attraction to gender is related with participant subjects of clinical trials. Based on percentage of subject of each gender it is calculating enrollment fracture, bias and some other indexes. Enrollment is very important parameter and genders is considering as one of the internal factors which is influencing to enrollment. Authors also marking the more prevalence of male above the female in some aspects of clinical trials. It is obviously that investigators also has a differences in gender and this could have a differences in some parameters and enrollment is one of them. Enrolment parameters also not developed very much. We stepped forward to find out the relations of gender’s investigator and the enrollment. Materials and methods: Data of four clinical trials II-III phases in oncology and hematology, conducted since 2007 to 2017 years has been used for retrospective analysis. Study objectives: to investigate the study recruitment rate using different parameters and it’s changes along with acting of gender’s of investigator; to develop new parameters and values (derivatives) which could be sensitive for evaluation of enrollment. Statistical analysis: data had been collected from feasibility questionnaires, open statistical sources. Results: It was showed the values of enrollment parameters in perspective of investigator’s gender. Discussion: Statistical differences in some existing and developed enrollment parameters has been found. Gender’s influence to enrollment also was investigated.
{"title":"Investigator’s gender and clinical trials performance in recruitment of patients","authors":"S. Milovanov","doi":"10.18203/2349-3259.ijct20230057","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20230057","url":null,"abstract":"Mostly of attraction to gender is related with participant subjects of clinical trials. Based on percentage of subject of each gender it is calculating enrollment fracture, bias and some other indexes. Enrollment is very important parameter and genders is considering as one of the internal factors which is influencing to enrollment. Authors also marking the more prevalence of male above the female in some aspects of clinical trials. It is obviously that investigators also has a differences in gender and this could have a differences in some parameters and enrollment is one of them. Enrolment parameters also not developed very much. We stepped forward to find out the relations of gender’s investigator and the enrollment. Materials and methods: Data of four clinical trials II-III phases in oncology and hematology, conducted since 2007 to 2017 years has been used for retrospective analysis. Study objectives: to investigate the study recruitment rate using different parameters and it’s changes along with acting of gender’s of investigator; to develop new parameters and values (derivatives) which could be sensitive for evaluation of enrollment. Statistical analysis: data had been collected from feasibility questionnaires, open statistical sources. Results: It was showed the values of enrollment parameters in perspective of investigator’s gender. Discussion: Statistical differences in some existing and developed enrollment parameters has been found. Gender’s influence to enrollment also was investigated.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"41 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74070062","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 : 2023-01-23DOI: 10.18203/2349-3259.ijct20230053
R. Koca, Aysel Gurkan, Hasan Fehmi Küçük
Background: It has been shown that the formation of an ostomy affects sleep quality, and sleep problems or insomnia cause fatigue in daily life, reducing the health-related quality of life. This trial aims to investigate the effects of sleep hygiene education and lavender oil inhalation alone and in combination on sleep quality, fatigue, and health-related quality of life in adults with an ostomy. Methods: This trial has been planned as a randomized controlled clinical trial and will use a 2×2 factor design in which an equal number of participants meeting the inclusion criteria will be randomly allocated to one of four groups. The study sample will comprise 120 adult patients who have undergone ostomy surgery in a city hospital in Turkey. Lavender oil inhalation together with sleep hygiene education will be applied in the first group (n=30), only sleep hygiene education in the second group (n=30), only lavender oil inhalation in the third group (n=30), and no intervention in the fourth group (n=30). The sleep quality of the groups will be evaluated using the Pittsburgh sleep quality index, their fatigue levels with the chalder fatigue scale, and their quality of life with the ostomy a quality-of-life scale. Conclusions: Non-pharmacological interventions are needed to prevent sleep and/or other problems that may develop due to insomnia in adults with ostomy. By evaluating the effects of these interventions, this trial will provide valuable evidence to guide clinical practice. Trial registration: This trial was registered in October 2022 (NCT05573256).
{"title":"Effects of sleep hygiene education and lavender oil inhalation on sleep quality, fatigue, and health-related quality of life in adults with an ostomy: a randomized controlled trial protocol","authors":"R. Koca, Aysel Gurkan, Hasan Fehmi Küçük","doi":"10.18203/2349-3259.ijct20230053","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20230053","url":null,"abstract":"Background: It has been shown that the formation of an ostomy affects sleep quality, and sleep problems or insomnia cause fatigue in daily life, reducing the health-related quality of life. This trial aims to investigate the effects of sleep hygiene education and lavender oil inhalation alone and in combination on sleep quality, fatigue, and health-related quality of life in adults with an ostomy.\u0000Methods: This trial has been planned as a randomized controlled clinical trial and will use a 2×2 factor design in which an equal number of participants meeting the inclusion criteria will be randomly allocated to one of four groups. The study sample will comprise 120 adult patients who have undergone ostomy surgery in a city hospital in Turkey. Lavender oil inhalation together with sleep hygiene education will be applied in the first group (n=30), only sleep hygiene education in the second group (n=30), only lavender oil inhalation in the third group (n=30), and no intervention in the fourth group (n=30). The sleep quality of the groups will be evaluated using the Pittsburgh sleep quality index, their fatigue levels with the chalder fatigue scale, and their quality of life with the ostomy a quality-of-life scale.\u0000Conclusions: Non-pharmacological interventions are needed to prevent sleep and/or other problems that may develop due to insomnia in adults with ostomy. By evaluating the effects of these interventions, this trial will provide valuable evidence to guide clinical practice.\u0000Trial registration: This trial was registered in October 2022 (NCT05573256).","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88241956","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 : 2023-01-23DOI: 10.18203/2349-3259.ijct20230046
Pravinkumar Bharde, Rajalingam Venkat Sai, S. Sripriya, Umamaheshwar Reddy, Swapna
Background: The present study was conducted with the primary aim of evaluating the role of computed tomography imaging in the assessment of blunt abdominal trauma (BAT) and penetrating abdominal trauma injuries. Methods: This prospective study comprised 53 patients with BAT and PAT injuries referred from the emergency department to the department of radio-diagnosis for ultrasonography and CT. Multidetector computed tomography scans were performed on GE Bright Speed Elite 16 slice CT Scanner. The various injuries seen on the CT images were grouped and examined based on the injury site and the organs involved. Results: The majority of the study subjects, i.e., 17/53 (32.08%) belonged age group of 20-30 yrs. Out of the 53 study subjects, 48 had BAT and 5 had PAT. The majority of study subjects who had BAT, i.e., 26/48 RTA, was the cause of trauma, and 5 out of 5 who had PAT assault was the cause of trauma. The most common organ injured was the spleen (18), followed by the liver (17), bowel (15), Anterior abdominal wall (6), pancreas (1), Kidney (1), Uterus (2), Multiple organs (1) and Hemoperitoneum without solid organ injury (1). CT showed 100% accuracy in the diagnosis of abdominal organ injuries. Conclusions: CT imaging plays a pivotal role in the rapid identification of life-threatening injuries and is helpful for prompt initiation of appropriate care, which leads to an increase in the chance of survival of patients with BAT and PAT injuries.
{"title":"Role of computed tomography imaging in the diagnosis of blunt and penetrating abdominal trauma injuries","authors":"Pravinkumar Bharde, Rajalingam Venkat Sai, S. Sripriya, Umamaheshwar Reddy, Swapna","doi":"10.18203/2349-3259.ijct20230046","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20230046","url":null,"abstract":"Background: The present study was conducted with the primary aim of evaluating the role of computed tomography imaging in the assessment of blunt abdominal trauma (BAT) and penetrating abdominal trauma injuries.\u0000Methods: This prospective study comprised 53 patients with BAT and PAT injuries referred from the emergency department to the department of radio-diagnosis for ultrasonography and CT. Multidetector computed tomography scans were performed on GE Bright Speed Elite 16 slice CT Scanner. The various injuries seen on the CT images were grouped and examined based on the injury site and the organs involved.\u0000Results: The majority of the study subjects, i.e., 17/53 (32.08%) belonged age group of 20-30 yrs. Out of the 53 study subjects, 48 had BAT and 5 had PAT. The majority of study subjects who had BAT, i.e., 26/48 RTA, was the cause of trauma, and 5 out of 5 who had PAT assault was the cause of trauma. The most common organ injured was the spleen (18), followed by the liver (17), bowel (15), Anterior abdominal wall (6), pancreas (1), Kidney (1), Uterus (2), Multiple organs (1) and Hemoperitoneum without solid organ injury (1). CT showed 100% accuracy in the diagnosis of abdominal organ injuries.\u0000Conclusions: CT imaging plays a pivotal role in the rapid identification of life-threatening injuries and is helpful for prompt initiation of appropriate care, which leads to an increase in the chance of survival of patients with BAT and PAT injuries.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82603355","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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