Pub Date : 2024-04-24DOI: 10.18203/2349-3259.ijct20240960
Efthalia Panagiotopoulou, A. Mavronasou, Savvas Spanos, Eleni A. Kortianou
Background: The COVID-19 pandemic has triggered rapid adaptive actions in favor of remote interventions and clinical assessment methods. The reliability of functional tests used in remote assessment is limited in patients with chronic stroke. The aim of the study was to assess the inter-reliability of the Berg balance scale, the timed-up and go test, and the box and block test via remote assessment, in patients with chronic stroke. Methods: Fifteen patients (8 men and 7 women) underwent a home-based teleassessment using a software platform and a center-based face-to-face assessment, on two consecutive days. The assessment order was randomized and conducted by an independent examiner. All participants were instructed regarding the use of the software platform, home equipment preparation, and safety issues Results: Participants aged 50-70 years (mean 59.6±7.34) with an average of 4.8±2.5 years after stroke and a moderate degree of motor dependence (Barthel scale: mean 83±8.61 units) completed all tests in both assessment procedures without experiencing adverse events. The inter-reliability was moderate for the total BBS score: ICC=0.869 (95% CI: 0.616 to 0.955), excellent for the total time of the TUG: ICC=0.968 (95% CI: 0.907 to 0.989) as well as for the upper right and left arm scores of the BBT: ICC=0.974 (95% CI: 0.922 to 0.991) and ICC=0.966 (95% CI: 0.897 to 0.988), respectively. Conclusions: Tele-assessment for BBS, TUG, and BBT appears moderate to excellent inter-reliability in functionally independent patients with chronic stroke.
{"title":"Tele-assessment of Berg balance scale, timed-up, go and box and block test in patients with chronic stroke: establishing agreement with the face-to-face assessment","authors":"Efthalia Panagiotopoulou, A. Mavronasou, Savvas Spanos, Eleni A. Kortianou","doi":"10.18203/2349-3259.ijct20240960","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240960","url":null,"abstract":"Background: The COVID-19 pandemic has triggered rapid adaptive actions in favor of remote interventions and clinical assessment methods. The reliability of functional tests used in remote assessment is limited in patients with chronic stroke. The aim of the study was to assess the inter-reliability of the Berg balance scale, the timed-up and go test, and the box and block test via remote assessment, in patients with chronic stroke.\u0000Methods: Fifteen patients (8 men and 7 women) underwent a home-based teleassessment using a software platform and a center-based face-to-face assessment, on two consecutive days. The assessment order was randomized and conducted by an independent examiner. All participants were instructed regarding the use of the software platform, home equipment preparation, and safety issues\u0000Results: Participants aged 50-70 years (mean 59.6±7.34) with an average of 4.8±2.5 years after stroke and a moderate degree of motor dependence (Barthel scale: mean 83±8.61 units) completed all tests in both assessment procedures without experiencing adverse events. The inter-reliability was moderate for the total BBS score: ICC=0.869 (95% CI: 0.616 to 0.955), excellent for the total time of the TUG: ICC=0.968 (95% CI: 0.907 to 0.989) as well as for the upper right and left arm scores of the BBT: ICC=0.974 (95% CI: 0.922 to 0.991) and ICC=0.966 (95% CI: 0.897 to 0.988), respectively.\u0000Conclusions: Tele-assessment for BBS, TUG, and BBT appears moderate to excellent inter-reliability in functionally independent patients with chronic stroke.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"41 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140662934","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 : 2024-04-24DOI: 10.18203/2349-3259.ijct20240965
Sara Monteiro, Teresa Tavares, Luís Salazar, Filipa Coelho, João Carvalho, Telma Barbosa, Maria G. Reis, Lurdes Morais, Ana Ramos, Manuel Ferreira-Magalhães
Background: Pneumonia, the leading infectious cause of death in children worldwide, often requires a chest radiograph (CXR) for diagnosis, involving radiation exposure. Point-of-Care Ultrasound (POCUS) offers a radiation-free alternative and, specifically the pocket-size variant, enhances convenience at the patient's bedside. While evidence supports ultrasound's accuracy in detecting community-acquired pneumonia (CAP) in children comparable to CXR, few studies have explored its ability to distinguish pneumonia etiology, especially utilizing pocket-size POCUS devices. Methods: In this prospective diagnostic cohort study conducted over a year in a tertiary pediatric referral center, we aim to assess the diagnostic accuracy of a pocket-size POCUS device compared to CXR for determining the etiology of CAP in pediatric patients (aged >6 months and <18 years). At least 76 participants diagnosed with CAP will undergo independent POCUS examinations at various intervals, complemented by CXRs when necessary, independently classified by a third investigator. The General Electrics Vscan AirTM®, featuring Bluetooth connectivity to smartphone/tablet, will be employed for POCUS. Data collection will include systematized POCUS and CXR descriptions, alongside sociodemographic, clinical, and therapeutic variables. Statistical analysis using SPSS® version 28 will evaluate the diagnostic accuracy of the POCUS device. Conclusions: This trial's outcomes hold significant promise in unveiling unknown data about the diagnostic accuracy of pocket-size POCUS for pediatric CAP etiological diagnosis. Utilizing a device meeting technical recommendations, featuring a dual-headed probe and Bluetooth connectivity, this study has the potential to bring innovation to clinical practice, improving patient care and creating scientific value. Trial Registration Number: NCT06296693.
{"title":"Diagnostic accuracy of pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized: a prospective diagnostic cohort study","authors":"Sara Monteiro, Teresa Tavares, Luís Salazar, Filipa Coelho, João Carvalho, Telma Barbosa, Maria G. Reis, Lurdes Morais, Ana Ramos, Manuel Ferreira-Magalhães","doi":"10.18203/2349-3259.ijct20240965","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240965","url":null,"abstract":"Background: Pneumonia, the leading infectious cause of death in children worldwide, often requires a chest radiograph (CXR) for diagnosis, involving radiation exposure. Point-of-Care Ultrasound (POCUS) offers a radiation-free alternative and, specifically the pocket-size variant, enhances convenience at the patient's bedside. While evidence supports ultrasound's accuracy in detecting community-acquired pneumonia (CAP) in children comparable to CXR, few studies have explored its ability to distinguish pneumonia etiology, especially utilizing pocket-size POCUS devices.\u0000Methods: In this prospective diagnostic cohort study conducted over a year in a tertiary pediatric referral center, we aim to assess the diagnostic accuracy of a pocket-size POCUS device compared to CXR for determining the etiology of CAP in pediatric patients (aged >6 months and <18 years). At least 76 participants diagnosed with CAP will undergo independent POCUS examinations at various intervals, complemented by CXRs when necessary, independently classified by a third investigator. The General Electrics Vscan AirTM®, featuring Bluetooth connectivity to smartphone/tablet, will be employed for POCUS. Data collection will include systematized POCUS and CXR descriptions, alongside sociodemographic, clinical, and therapeutic variables. Statistical analysis using SPSS® version 28 will evaluate the diagnostic accuracy of the POCUS device.\u0000Conclusions: This trial's outcomes hold significant promise in unveiling unknown data about the diagnostic accuracy of pocket-size POCUS for pediatric CAP etiological diagnosis. Utilizing a device meeting technical recommendations, featuring a dual-headed probe and Bluetooth connectivity, this study has the potential to bring innovation to clinical practice, improving patient care and creating scientific value.\u0000Trial Registration Number: NCT06296693.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140664994","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 : 2024-04-24DOI: 10.18203/2349-3259.ijct20240962
S. Chatio, J. Ganle, Ulrike Beisel, James Akazili, Patrick Ansah, P. Adongo
Background: The negative meaning and rumours associated with the conduct of clinical trials regarding their experimental nature adversely affect trust and their conduct. A typical example of the challenges in conducting clinical trial studies was where Ghana was selected to conduct the ebola vaccine trials, which was not successful. This study explored the social and political perspectives on the unsuccessful implementation of the ebola vaccine trial in Ghana. Methods: This was a cross-sectional exploratory study using qualitative research approach where 31 in-depth individual interviews and Key informant interviews were conducted with participants. The interviews were recorded, transcribed and coded into themes using Nvivo 12 software to aid thematic content analysis. Results: The views expressed by participants suggested that lack of stakeholder engagement to create awareness on the Ebola vaccine trial led to doubts on the purpose for the trial. Also, media propaganda, negative influence and the perception that conducting the vaccine trial in Ghana could introduce the Ebola virus into the country created panic and fear, which affected public trust and support for the Ebola vaccine trial conduct in Ghana. Furthermore, political influence linked with site selection and timing for the study in particular, led to mistrust and the subsequent suspension of the trial in Ghana. Conclusions: Based on the interpretation of our data, we conclude that the indefinite suspension of the Ebola vaccine trial in Ghana could largely be attributed to both fear and political influence as well as misinformation resulting from media propaganda leading to mistrust.
{"title":"Is it fear or politics? A qualitative exploration of stakeholders’ views on the failed Ebola vaccine trial in Southern Ghana","authors":"S. Chatio, J. Ganle, Ulrike Beisel, James Akazili, Patrick Ansah, P. Adongo","doi":"10.18203/2349-3259.ijct20240962","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240962","url":null,"abstract":"Background: The negative meaning and rumours associated with the conduct of clinical trials regarding their experimental nature adversely affect trust and their conduct. A typical example of the challenges in conducting clinical trial studies was where Ghana was selected to conduct the ebola vaccine trials, which was not successful. This study explored the social and political perspectives on the unsuccessful implementation of the ebola vaccine trial in Ghana.\u0000Methods: This was a cross-sectional exploratory study using qualitative research approach where 31 in-depth individual interviews and Key informant interviews were conducted with participants. The interviews were recorded, transcribed and coded into themes using Nvivo 12 software to aid thematic content analysis.\u0000Results: The views expressed by participants suggested that lack of stakeholder engagement to create awareness on the Ebola vaccine trial led to doubts on the purpose for the trial. Also, media propaganda, negative influence and the perception that conducting the vaccine trial in Ghana could introduce the Ebola virus into the country created panic and fear, which affected public trust and support for the Ebola vaccine trial conduct in Ghana. Furthermore, political influence linked with site selection and timing for the study in particular, led to mistrust and the subsequent suspension of the trial in Ghana.\u0000Conclusions: Based on the interpretation of our data, we conclude that the indefinite suspension of the Ebola vaccine trial in Ghana could largely be attributed to both fear and political influence as well as misinformation resulting from media propaganda leading to mistrust.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"19 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140660455","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}
Background: Controlling bleeding during arthroscopic shoulder surgery helps improve the clarity of the arthroscopic visual field. Adrenaline is considered an effective and safe method to reduce bleeding. Two doses of adrenaline (0.33 mg/l and 1 mg/l) have been evaluated in the literature, but never against each other. Methods: This prospective, double-blind, randomized controlled trial will study the clarity of the visual field using a numerical scale (NS) during rotator cuff surgery on 180 patients across 5 centres. The secondary objectives include: the duration of the operation, volume of saline used, increase in baseline pressure, number of arthropump hyperpressures, mean systolic blood pressure and heart rate, as well as sudden variability. Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p<0.001). Conclusions: This study aims to determine which of the two dosages previously studied in the literature (0.33 mg/l versus 1 mg/l) provides better clarity. Trial Registration Number: 2021-A02773-38.
{"title":"Comparison of the effects of two concentrations of adrenaline (0.33 mg/l versus 1 mg/l) in the irrigation serum for arthroscopic shoulder surgery: protocol of a randomized controlled trial","authors":"Edouard Harly, Anselme Billaud, H. Demezon, Thierry Joudet, Clément Tournier, Antony Pincin","doi":"10.18203/2349-3259.ijct20240966","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240966","url":null,"abstract":"Background: Controlling bleeding during arthroscopic shoulder surgery helps improve the clarity of the arthroscopic visual field. Adrenaline is considered an effective and safe method to reduce bleeding. Two doses of adrenaline (0.33 mg/l and 1 mg/l) have been evaluated in the literature, but never against each other.\u0000Methods: This prospective, double-blind, randomized controlled trial will study the clarity of the visual field using a numerical scale (NS) during rotator cuff surgery on 180 patients across 5 centres. The secondary objectives include: the duration of the operation, volume of saline used, increase in baseline pressure, number of arthropump hyperpressures, mean systolic blood pressure and heart rate, as well as sudden variability.\u0000Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p<0.001).\u0000Conclusions: This study aims to determine which of the two dosages previously studied in the literature (0.33 mg/l versus 1 mg/l) provides better clarity.\u0000Trial Registration Number: 2021-A02773-38. ","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"55 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140665057","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 : 2024-04-24DOI: 10.18203/2349-3259.ijct20240961
H. E. Lundberg, J. Sundgot-Borgen, Therese Fostervold Mathisen, Helge Holo, A. C. Whist, Stig Larsen
Background: Vitamin K2-rich Jarlsberg Cheese is demonstrated to increase Osteocalcin and bone turnover markers in fertile women. The impact on endurance-trained young cross-country skiers (XCS) with elevated bone turnover remains unclear. Purpose of study was to estimate the optimal daily efficacy dose of Jarlsberg cheese to increase serum Osteocalcin level in young female and male XCS and estimate the Jarlsberg effect on bone turnover markers (BTMs) and bone mineral density (BMD). Methods: In a parallel group study consisting of three design levels, 10 female and 10 male XCS were included, using Response Surface Pathway design. Blood samples were taken at each level for measurements of Osteocalcin, vitamin K2, BTMs and other biochemical parameters. Resting metabolic rate (RMR), BMD, VO2max and muscle strength were measured at start and at the end of the study. Results: The Osteocalcin development with increasing dose of Jarlsberg cheese was almost parallel in both sexes. These variables were reduced significantly from baseline during the first two design levels but increased above baseline by the end of the study. BTMs decreased significantly during the first and second level but increased during the third level. Total and L1-L4 BMD, s-phosphate, s-urea, RMR, muscle strength and Peak VO2 increased significantly while s-calcium and s-magnesium decreased. Conclusions: Estimated OED of Jarlsberg cheese was 73 and 84 g/day for females and male athletes, respectively. The development in OC, BTMs and BMD suggest an antiresorptive and perhaps anabolic effect of Jarlsberg Cheese on bone tissue. VO2 max, RMR and muscular strength development indicated an anabolic situation.
{"title":"Cheese positively affects serum osteocalcin levels, bone turnover markers and bone mineral density in cross-country skiers: a dose-response study","authors":"H. E. Lundberg, J. Sundgot-Borgen, Therese Fostervold Mathisen, Helge Holo, A. C. Whist, Stig Larsen","doi":"10.18203/2349-3259.ijct20240961","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240961","url":null,"abstract":"Background: Vitamin K2-rich Jarlsberg Cheese is demonstrated to increase Osteocalcin and bone turnover markers in fertile women. The impact on endurance-trained young cross-country skiers (XCS) with elevated bone turnover remains unclear. Purpose of study was to estimate the optimal daily efficacy dose of Jarlsberg cheese to increase serum Osteocalcin level in young female and male XCS and estimate the Jarlsberg effect on bone turnover markers (BTMs) and bone mineral density (BMD).\u0000Methods: In a parallel group study consisting of three design levels, 10 female and 10 male XCS were included, using Response Surface Pathway design. Blood samples were taken at each level for measurements of Osteocalcin, vitamin K2, BTMs and other biochemical parameters. Resting metabolic rate (RMR), BMD, VO2max and muscle strength were measured at start and at the end of the study.\u0000Results: The Osteocalcin development with increasing dose of Jarlsberg cheese was almost parallel in both sexes. These variables were reduced significantly from baseline during the first two design levels but increased above baseline by the end of the study. BTMs decreased significantly during the first and second level but increased during the third level. Total and L1-L4 BMD, s-phosphate, s-urea, RMR, muscle strength and Peak VO2 increased significantly while s-calcium and s-magnesium decreased.\u0000Conclusions: Estimated OED of Jarlsberg cheese was 73 and 84 g/day for females and male athletes, respectively. The development in OC, BTMs and BMD suggest an antiresorptive and perhaps anabolic effect of Jarlsberg Cheese on bone tissue. VO2 max, RMR and muscular strength development indicated an anabolic situation.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"65 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140665267","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 : 2024-04-24DOI: 10.18203/2349-3259.ijct20240964
Nikola Pluym, Therese Burkhardt, Max Scherer
Background: Despite decades of research on pharmacological and behavioural smoking cessation treatments, current quit aids are of limited success. The introduction of new, combustion-free nicotine and tobacco products extended the tool kit for people who smoke to switch away from their risky habit. We performed a systematic review including 120 studies resulting in several recommendations for a robust study design to determine the cessation efficacy of a new nicotine or tobacco product. Consequently, we prepared this study protocol to assess the cessation efficacy of heated tobacco products (HTPs) and nicotine pouches (NPs). Methods: 250 subjects (125 exclusive smokers and 125 exclusive smokeless tobacco (SLT) users) will be recruited and offered a choice of HTPs in case of smokers and a choice of NPs in case of SLT users in order to switch. Subjects will undergo four visits (baseline, 1, 3, and 6 months) to collect biospecimens and for physical examinations. Use behaviour and questionnaires will be monitored on a regular basis by means of a smartphone-app. We describe a sensitive and specific compliance monitoring using suitable biomarkers of exposure. The sample size of 250 subjects and duration of 6 months will allow the quit rates to be assessed with sufficient statistical power. Finally, the choice between different products shall reflect the individuals’ preferences. Conclusions: This protocol can be applied generically, providing a robust determination of a products’ cessation efficacy. Trial Registration: The trial will be registered in the International Clinical Trials Registry Platform.
{"title":"Exploring the cessation efficacy and harm reduction potential of heated tobacco and nicotine pouch products in smokers and smokeless tobacco users: study protocol of a 6-month randomized controlled switching trial","authors":"Nikola Pluym, Therese Burkhardt, Max Scherer","doi":"10.18203/2349-3259.ijct20240964","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240964","url":null,"abstract":"Background: Despite decades of research on pharmacological and behavioural smoking cessation treatments, current quit aids are of limited success. The introduction of new, combustion-free nicotine and tobacco products extended the tool kit for people who smoke to switch away from their risky habit. We performed a systematic review including 120 studies resulting in several recommendations for a robust study design to determine the cessation efficacy of a new nicotine or tobacco product. Consequently, we prepared this study protocol to assess the cessation efficacy of heated tobacco products (HTPs) and nicotine pouches (NPs).\u0000Methods: 250 subjects (125 exclusive smokers and 125 exclusive smokeless tobacco (SLT) users) will be recruited and offered a choice of HTPs in case of smokers and a choice of NPs in case of SLT users in order to switch. Subjects will undergo four visits (baseline, 1, 3, and 6 months) to collect biospecimens and for physical examinations. Use behaviour and questionnaires will be monitored on a regular basis by means of a smartphone-app. We describe a sensitive and specific compliance monitoring using suitable biomarkers of exposure. The sample size of 250 subjects and duration of 6 months will allow the quit rates to be assessed with sufficient statistical power. Finally, the choice between different products shall reflect the individuals’ preferences.\u0000Conclusions: This protocol can be applied generically, providing a robust determination of a products’ cessation efficacy.\u0000Trial Registration: The trial will be registered in the International Clinical Trials Registry Platform.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"2 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140661538","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}
Background: CAUTI bundle care aims to reduce catheter associated urinary tract infection, enhance quality of life and promote comfort. The present study aimed to assess the effect of CAUTI bundle approach on urinary catheter associated infection rate among children admitted in paediatric unit of KGMU. Methods: Quantitative research approach was done on 46 children who were admitted in paediatric unit, KGMU, Lucknow. Purposive sampling technique was used. Socio demographic was obtained by socio demographic Performa, CAUTI was assessed by urine culture test and symptomatic assessment of UTI. Results: The result revealed that on the basis of urine culture results, in exposed group majority of the children that is 18 (78.26%) was sterile and rest 5 (21.73%) was infected and in unexposed group 13 (56.52%) children was sterile and remain 10 (43.47%) was infected. And on the basis of symptomatic assessment for CAUTI, in exposed group majority of the children that is 17 (73.91%) are less symptomatic and remain 6 (26.08%) was more symptomatic for CAUTI and in unexposed group most of the children that is 14 (60.86%) was less symptomatic for CAUTI and rest 9 (39.13%) was more symptomatic for CAUTI. Conclusions: CAUTI bundles approach provides evidence-based prevention practices and strategies to reduce CAUTI. The present study found that CAUTI bundle care was effective in reducing CAUTI in children.
{"title":"Effectiveness of catheter-associated urinary tract infections bundle approach to reduce urinary catheter associated infection rate among children admitted in Paediatric unit","authors":"Anju Shukla, Subin S., Anugrah Charan, Neeraj Aanand","doi":"10.18203/2349-3259.ijct20240963","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240963","url":null,"abstract":"Background: CAUTI bundle care aims to reduce catheter associated urinary tract infection, enhance quality of life and promote comfort. The present study aimed to assess the effect of CAUTI bundle approach on urinary catheter associated infection rate among children admitted in paediatric unit of KGMU.\u0000Methods: Quantitative research approach was done on 46 children who were admitted in paediatric unit, KGMU, Lucknow. Purposive sampling technique was used. Socio demographic was obtained by socio demographic Performa, CAUTI was assessed by urine culture test and symptomatic assessment of UTI.\u0000Results: The result revealed that on the basis of urine culture results, in exposed group majority of the children that is 18 (78.26%) was sterile and rest 5 (21.73%) was infected and in unexposed group 13 (56.52%) children was sterile and remain 10 (43.47%) was infected. And on the basis of symptomatic assessment for CAUTI, in exposed group majority of the children that is 17 (73.91%) are less symptomatic and remain 6 (26.08%) was more symptomatic for CAUTI and in unexposed group most of the children that is 14 (60.86%) was less symptomatic for CAUTI and rest 9 (39.13%) was more symptomatic for CAUTI.\u0000Conclusions: CAUTI bundles approach provides evidence-based prevention practices and strategies to reduce CAUTI. The present study found that CAUTI bundle care was effective in reducing CAUTI in children.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"3 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140661870","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}
Background: Hair loss, a common multifactorial condition affecting both genders, results from causes like extrinsic factors (pollution, sun, humidity, and temperature), nutritional variation, or intrinsic factors such as ageing, heredity, hormonal and medical conditions. Some of the damages caused by these factors can be effectively managed with multivitamins, minerals, antioxidant natural products. Present study assessed use of standardised herbal Sesbania grandiflora extract for improving hair density, hair thickness and scalp health along with a serum biomarker to establish the probable mechanism of action. Methods: The study was approved by the ethics committee and was conducted as per standard national regulations. 51 randomized subjects (mean age: 39.40±5.80 years) received either test-treatment or placebo for consecutive 56 days. Instrumental assessments included a phototrichogram to assess hair density, thickness, and scalp condition. Results: SesZen-BioTM which is derived from Sesbania grandiflora extracts showed an improvement in hair density, hair thickness and ferritin in 8 weeks of usage suggesting it stimulates the keratin production which resulted in improved follicle growth. By day 56 of usage, hair density and thickness improved by 58.92±28.69 cm2 and 3.68±2.69 μm respectively from baseline (both p<0.0001) in the treatment group. This indicates towards 25% improvement in hair density, 16.94% in hair thickness and almost 72% volunteers indicated an improvement in hair health along with 27% increase in serum ferritin. Conclusions: Sesbania grandiflora extract -SesZen-Bio® showed beneficial nutritional effects on research subjects, proving its usefulness as a well-tolerated and efficient daily supplement to improve hair health.
{"title":"A prospective, randomized double-blind, placebo-controlled study for safety and efficacy of SesZen-BioTM: a proprietary Sesbania grandiflora extract in managing hair and scalp health in healthy adults","authors":"Ratna Upadhyay, Mihir C. Gadani, Sneha Badak, Nayan Patel, Apeksha Merja, Maheshvari Patel","doi":"10.18203/2349-3259.ijct20240929","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240929","url":null,"abstract":"Background: Hair loss, a common multifactorial condition affecting both genders, results from causes like extrinsic factors (pollution, sun, humidity, and temperature), nutritional variation, or intrinsic factors such as ageing, heredity, hormonal and medical conditions. Some of the damages caused by these factors can be effectively managed with multivitamins, minerals, antioxidant natural products. Present study assessed use of standardised herbal Sesbania grandiflora extract for improving hair density, hair thickness and scalp health along with a serum biomarker to establish the probable mechanism of action.\u0000Methods: The study was approved by the ethics committee and was conducted as per standard national regulations. 51 randomized subjects (mean age: 39.40±5.80 years) received either test-treatment or placebo for consecutive 56 days. Instrumental assessments included a phototrichogram to assess hair density, thickness, and scalp condition.\u0000Results: SesZen-BioTM which is derived from Sesbania grandiflora extracts showed an improvement in hair density, hair thickness and ferritin in 8 weeks of usage suggesting it stimulates the keratin production which resulted in improved follicle growth. By day 56 of usage, hair density and thickness improved by 58.92±28.69 cm2 and 3.68±2.69 μm respectively from baseline (both p<0.0001) in the treatment group. This indicates towards 25% improvement in hair density, 16.94% in hair thickness and almost 72% volunteers indicated an improvement in hair health along with 27% increase in serum ferritin.\u0000Conclusions: Sesbania grandiflora extract -SesZen-Bio® showed beneficial nutritional effects on research subjects, proving its usefulness as a well-tolerated and efficient daily supplement to improve hair health.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"12 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140734913","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 : 2024-03-01DOI: 10.18203/2349-3259.ijct20240655
A. Mavronasou, Vaia Sapouna, A. Spinou, Konstantinos Douros, Eleni A. Kortianou
Background: Home-based remote rehabilitation combining the use of new technological tools is an alternative way of rehabilitation when traditional center-based programs are limited or are not feasible. This systematic review aims to investigate the level of evidence for the effects of home-based remote rehabilitation on children and adolescents with cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (NCFB). Methods: This systematic review will follow the preferred reporting items for systematic reviews and meta-analysis (PRISMA). Five databases will be searched from the period of the inception until March 2024: PubMed, Web of Science, Medline (via EBSCOhost), ACM Digital Library, and Scopus. Methodological quality will be assessed using the revised Cochrane Risk of Bias tool for randomized trials (RoB 2) and the risk of bias in non-randomized studies – of interventions (ROBINS-1) tool. The overall quality of the evidence will be assessed using the grading of recommendations assessment, development, and evaluation (GRADE) approach. Conclusions: Evaluation of the level of evidence for the effects of home-based remote rehabilitation in children and adolescents with CF and NCFB is an important step in the context of telehealth, providing an alternative way of approaching pediatric patients, during the process of rehabilitation. Trial registration: PROSPERO registration number is CRD42024498403.
背景：当传统的中心康复项目受到限制或不可行时，结合使用新技术工具的家庭远程康复是另一种康复方式。本系统综述旨在调查家庭远程康复对囊性纤维化（CF）和非囊性纤维化支气管扩张症（NCFB）儿童和青少年的影响的证据水平：本系统综述将遵循系统综述和荟萃分析的首选报告项目（PRISMA）。从开始到 2024 年 3 月，将检索五个数据库：PubMed、Web of Science、Medline（通过 EBSCOhost）、ACM Digital Library 和 Scopus。方法学质量将使用修订后的科克伦随机试验偏倚风险工具（RoB 2）和非随机干预研究偏倚风险工具（ROBINS-1）进行评估。证据的总体质量将采用建议评估、制定和评价分级法（GRADE）进行评估：对 CF 和 NCFB 儿童和青少年家庭远程康复效果的证据水平进行评估是远程医疗背景下的重要一步，为儿科患者在康复过程中提供了另一种方法：PROSPERO注册号为CRD42024498403。
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Pub Date : 2024-02-23DOI: 10.18203/2349-3259.ijct20240400
Shalini Srivastava, R. Girandola
Background: A feasibility study was conducted to investigate the effect of different proprietary extracts on joint discomfort associated with repeated episodes of physical activity. Methods: A single-dose randomized, double-blind, placebo-controlled cross-over study was conducted in three phases with different extract combinations. Seventeen individuals aged 40-60 years with a history of knee joint pain aggravation on physical stress were randomized to receive the investigational product or the placebo in a 1:1 ratio. The primary outcome was the time taken to achieve meaningful pain relief (MPR) from baseline using a pain visual analog scale (VAS) compared to the placebo. The secondary outcomes were the pain intensity difference (PID) and joint discomfort at 1-, 2-, 3-, and 4-hours post-product administration and the time-weighted sum of pain intensity difference (SPID) over 4 hours compared to placebo. Results: Participants in two out of eight investigational product groups achieved MPR successfully. The proprietary combination ZV-E (consisting of Z. officinale and V. negundo) showed the fastest pain reduction with more than 50% of the participants achieving meaningful relief. The BS-ZP (consisting of B. serrata + Z. officinale + P. lanceolata) group also had more than 50% of participants reporting MPR at 4 hours post-IP administration. Subsequently, the SPID was found to be lowest in the participants of above stated groups. Conclusions: The proprietary combination of Z. officinale and V. negundo extracts, 200 mg could be a promising lead to conduct a further trial to investigate its effect on joint pain.
背景：我们开展了一项可行性研究，以探讨不同的专有提取物对反复运动引起的关节不适的影响：我们开展了一项可行性研究，以调查不同的专利提取物对反复体育锻炼引起的关节不适的影响：方法：一项单剂量随机、双盲、安慰剂对照交叉研究分三个阶段进行，采用不同的提取物组合。17名年龄在40-60岁之间、有膝关节疼痛病史且在体力活动时疼痛加剧的患者按1:1的比例随机接受了研究产品或安慰剂。主要结果是与安慰剂相比，使用疼痛视觉模拟量表（VAS）从基线达到有意义的疼痛缓解（MPR）所需的时间。次要结果是与安慰剂相比，服用产品后1、2、3和4小时的疼痛强度差异（PID）和关节不适感，以及4小时内疼痛强度差异的时间加权总和（SPID）：结果：八个研究产品组中有两个组的参与者成功实现了MPR。专有组合 ZV-E（由 Z. officinale 和 V. negundo 组成）的疼痛减轻速度最快，50% 以上的参与者获得了有意义的缓解。BS-ZP（由 B. serrata + Z. officinale + P. lanceolata 组成）组也有 50%以上的参与者在服用后 4 小时报告了 MPR。随后，发现上述组别的参与者的 SPID 最低：结论：200 毫克 Z. officinale 和 V. negundo 提取物的专有组合很有希望成为进一步研究其对关节疼痛影响的试验线索。
{"title":"Screening of herbal extracts for rapid effect on activity-induced knee joint discomfort: a randomized, placebo-controlled pilot study","authors":"Shalini Srivastava, R. Girandola","doi":"10.18203/2349-3259.ijct20240400","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240400","url":null,"abstract":"Background: A feasibility study was conducted to investigate the effect of different proprietary extracts on joint discomfort associated with repeated episodes of physical activity.\u0000Methods: A single-dose randomized, double-blind, placebo-controlled cross-over study was conducted in three phases with different extract combinations. Seventeen individuals aged 40-60 years with a history of knee joint pain aggravation on physical stress were randomized to receive the investigational product or the placebo in a 1:1 ratio. The primary outcome was the time taken to achieve meaningful pain relief (MPR) from baseline using a pain visual analog scale (VAS) compared to the placebo. The secondary outcomes were the pain intensity difference (PID) and joint discomfort at 1-, 2-, 3-, and 4-hours post-product administration and the time-weighted sum of pain intensity difference (SPID) over 4 hours compared to placebo.\u0000Results: Participants in two out of eight investigational product groups achieved MPR successfully. The proprietary combination ZV-E (consisting of Z. officinale and V. negundo) showed the fastest pain reduction with more than 50% of the participants achieving meaningful relief. The BS-ZP (consisting of B. serrata + Z. officinale + P. lanceolata) group also had more than 50% of participants reporting MPR at 4 hours post-IP administration. Subsequently, the SPID was found to be lowest in the participants of above stated groups.\u0000Conclusions: The proprietary combination of Z. officinale and V. negundo extracts, 200 mg could be a promising lead to conduct a further trial to investigate its effect on joint pain.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"130 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140438356","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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