Pub Date : 2024-02-05DOI: 10.18203/2349-3259.ijct20240303
Mihir Gadani, Sneha Badak, Ratna Upadhyay
Background: There are several concerns related to combating signs of ageing. Considering the long-term safety concerns of cosmetic formulations, a safe and effective approach using nutritional supplements and naturals should be of great help. CollabZenTM is one such a blend of three plant materials known as Phyllanthus emblica, Camellia sinensis, and Coffea arabica, earlier tested for collagen building in human cells in-vitro. The current study aims to explore its potential as a nutraceutical product for skin ageing. Methods: The study enrolled 64 volunteers both genders (mean age=45.75) with crow's feet wrinkles. One group (n=32) received a placebo capsule (Product A) and other group received CollabZenTM capsules (Product B). Dermatological parameters were assessed at 0th day, 4th and 8th week, and self-assessment questionnaires for efficacy and tolerance were collected on 4th and 8th week. The trial is registered at https://ctri.nic.in/, CTRI/2022/10/046168. Results: The results showed that product B (CollabZenTM) was significantly effective than the placebo in improving deep skin hydration on the face (p=0.009), increasing facial skin elasticity (p=0.001), and enhancing firmness (p=0.001) after 8 weeks. Participants in Group B reported higher levels of satisfaction regarding their perceived skin health compared to group A based on self-assessment at the 8th weeks (p<0.01). Moreover, only one volunteer in each group experienced mild intolerance at the end of 8th week, demonstrating the safety of these nutraceutical ingredients and excipients. Conclusions: CollabZenTM, with its known antioxidant and collagen-boosting properties and current findings can be considered a valuable nutraceutical product for the anti-ageing sector of the cosmetic industry.
{"title":"Anti-ageing effects of CollabZenTM in healthy human volunteers: a randomized, double blind, placebo-controlled study","authors":"Mihir Gadani, Sneha Badak, Ratna Upadhyay","doi":"10.18203/2349-3259.ijct20240303","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240303","url":null,"abstract":"Background: There are several concerns related to combating signs of ageing. Considering the long-term safety concerns of cosmetic formulations, a safe and effective approach using nutritional supplements and naturals should be of great help. CollabZenTM is one such a blend of three plant materials known as Phyllanthus emblica, Camellia sinensis, and Coffea arabica, earlier tested for collagen building in human cells in-vitro. The current study aims to explore its potential as a nutraceutical product for skin ageing.\u0000Methods: The study enrolled 64 volunteers both genders (mean age=45.75) with crow's feet wrinkles. One group (n=32) received a placebo capsule (Product A) and other group received CollabZenTM capsules (Product B). Dermatological parameters were assessed at 0th day, 4th and 8th week, and self-assessment questionnaires for efficacy and tolerance were collected on 4th and 8th week. The trial is registered at https://ctri.nic.in/, CTRI/2022/10/046168.\u0000Results: The results showed that product B (CollabZenTM) was significantly effective than the placebo in improving deep skin hydration on the face (p=0.009), increasing facial skin elasticity (p=0.001), and enhancing firmness (p=0.001) after 8 weeks. Participants in Group B reported higher levels of satisfaction regarding their perceived skin health compared to group A based on self-assessment at the 8th weeks (p<0.01). Moreover, only one volunteer in each group experienced mild intolerance at the end of 8th week, demonstrating the safety of these nutraceutical ingredients and excipients.\u0000Conclusions: CollabZenTM, with its known antioxidant and collagen-boosting properties and current findings can be considered a valuable nutraceutical product for the anti-ageing sector of the cosmetic industry.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139862613","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 : 2024-02-05DOI: 10.18203/2349-3259.ijct20240303
Mihir Gadani, Sneha Badak, Ratna Upadhyay
Background: There are several concerns related to combating signs of ageing. Considering the long-term safety concerns of cosmetic formulations, a safe and effective approach using nutritional supplements and naturals should be of great help. CollabZenTM is one such a blend of three plant materials known as Phyllanthus emblica, Camellia sinensis, and Coffea arabica, earlier tested for collagen building in human cells in-vitro. The current study aims to explore its potential as a nutraceutical product for skin ageing. Methods: The study enrolled 64 volunteers both genders (mean age=45.75) with crow's feet wrinkles. One group (n=32) received a placebo capsule (Product A) and other group received CollabZenTM capsules (Product B). Dermatological parameters were assessed at 0th day, 4th and 8th week, and self-assessment questionnaires for efficacy and tolerance were collected on 4th and 8th week. The trial is registered at https://ctri.nic.in/, CTRI/2022/10/046168. Results: The results showed that product B (CollabZenTM) was significantly effective than the placebo in improving deep skin hydration on the face (p=0.009), increasing facial skin elasticity (p=0.001), and enhancing firmness (p=0.001) after 8 weeks. Participants in Group B reported higher levels of satisfaction regarding their perceived skin health compared to group A based on self-assessment at the 8th weeks (p<0.01). Moreover, only one volunteer in each group experienced mild intolerance at the end of 8th week, demonstrating the safety of these nutraceutical ingredients and excipients. Conclusions: CollabZenTM, with its known antioxidant and collagen-boosting properties and current findings can be considered a valuable nutraceutical product for the anti-ageing sector of the cosmetic industry.
{"title":"Anti-ageing effects of CollabZenTM in healthy human volunteers: a randomized, double blind, placebo-controlled study","authors":"Mihir Gadani, Sneha Badak, Ratna Upadhyay","doi":"10.18203/2349-3259.ijct20240303","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240303","url":null,"abstract":"Background: There are several concerns related to combating signs of ageing. Considering the long-term safety concerns of cosmetic formulations, a safe and effective approach using nutritional supplements and naturals should be of great help. CollabZenTM is one such a blend of three plant materials known as Phyllanthus emblica, Camellia sinensis, and Coffea arabica, earlier tested for collagen building in human cells in-vitro. The current study aims to explore its potential as a nutraceutical product for skin ageing.\u0000Methods: The study enrolled 64 volunteers both genders (mean age=45.75) with crow's feet wrinkles. One group (n=32) received a placebo capsule (Product A) and other group received CollabZenTM capsules (Product B). Dermatological parameters were assessed at 0th day, 4th and 8th week, and self-assessment questionnaires for efficacy and tolerance were collected on 4th and 8th week. The trial is registered at https://ctri.nic.in/, CTRI/2022/10/046168.\u0000Results: The results showed that product B (CollabZenTM) was significantly effective than the placebo in improving deep skin hydration on the face (p=0.009), increasing facial skin elasticity (p=0.001), and enhancing firmness (p=0.001) after 8 weeks. Participants in Group B reported higher levels of satisfaction regarding their perceived skin health compared to group A based on self-assessment at the 8th weeks (p<0.01). Moreover, only one volunteer in each group experienced mild intolerance at the end of 8th week, demonstrating the safety of these nutraceutical ingredients and excipients.\u0000Conclusions: CollabZenTM, with its known antioxidant and collagen-boosting properties and current findings can be considered a valuable nutraceutical product for the anti-ageing sector of the cosmetic industry.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139802738","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 : 2024-01-24DOI: 10.18203/2349-3259.ijct20240044
Venkadalakshmi V., M. Dhandapani, Shalini Gainder, Vikas Suri, Karobi Das, Rajesh Vejeyvergiya, Abhishek Ghosh, Poonam Khanna, Rajan Chellappa, Babina
Background: Women who have experienced pre-eclampsia (PE) may also face additional health problems in later life, as the condition is associated with an increased risk of death from 2-fold increased risk of long-term cardiovascular disease (CVD), hypertension, stroke, an approximate 5-12-fold increased risk of end-stage renal disease (ESRD), metabolic syndrome, and diabetes. Methods: Method was randomized controlled trial. Women with PE who delivered in PGIMER will be enrolled and will be allocated into experimental ad control group using a computer random table with allocation concealment. Enrolment will be done at the time of discharge; baseline assessment will be done 6 weeks and the intervention bundle will be implemented to the women in experimental group. The women in control group will receive routine care. Women in both the groups will be followed up at 6 months. Conclusions: This study aims to determine the effectiveness of “extended postpartum comprehensive health care bundle (EP CHC bundle)” on selected outcomes of women with preeclampsia at 6 months. The comprehensive health care bundle will be designed with the inputs from all stakeholders, has the potential to suit the dynamic nature of management of women with preeclampsia after delivery. CTRI registration number: CTRI/2021/04/032749 ON 12/4/2021
{"title":"The effectiveness of extended postpartum comprehensive health care bundle selected outcomes of women with preeclampsia at 6 months: protocol of a randomized controlled trial","authors":"Venkadalakshmi V., M. Dhandapani, Shalini Gainder, Vikas Suri, Karobi Das, Rajesh Vejeyvergiya, Abhishek Ghosh, Poonam Khanna, Rajan Chellappa, Babina","doi":"10.18203/2349-3259.ijct20240044","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240044","url":null,"abstract":"Background: Women who have experienced pre-eclampsia (PE) may also face additional health problems in later life, as the condition is associated with an increased risk of death from 2-fold increased risk of long-term cardiovascular disease (CVD), hypertension, stroke, an approximate 5-12-fold increased risk of end-stage renal disease (ESRD), metabolic syndrome, and diabetes.\u0000Methods: Method was randomized controlled trial. Women with PE who delivered in PGIMER will be enrolled and will be allocated into experimental ad control group using a computer random table with allocation concealment. Enrolment will be done at the time of discharge; baseline assessment will be done 6 weeks and the intervention bundle will be implemented to the women in experimental group. The women in control group will receive routine care. Women in both the groups will be followed up at 6 months.\u0000Conclusions: This study aims to determine the effectiveness of “extended postpartum comprehensive health care bundle (EP CHC bundle)” on selected outcomes of women with preeclampsia at 6 months. The comprehensive health care bundle will be designed with the inputs from all stakeholders, has the potential to suit the dynamic nature of management of women with preeclampsia after delivery.\u0000CTRI registration number: CTRI/2021/04/032749 ON 12/4/2021","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139599126","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 : 2024-01-24DOI: 10.18203/2349-3259.ijct20240040
Sachin Nagar, Naresh Paliwal, Robin Lohia, Vivek Saluja, Narender Dutt
Background: Many prior studies have utilized thoracic or lumbar spinal anesthesia with isobaric/hyperbaric bupivacaine or Ropivacaine and opioids for laparoscopic cholecystectomy and have reported variable results. our study is centered around addressing the occurrence of intraoperative right shoulder pain and its potential impact on the need for conversion to general anesthesia. Methods: This is a prospective comparative case series study in which 70 patients scheduled for elective laparoscopic cholecystectomy were. Patients in Group R received 1 ml (1 mg) of Hypobaric Ropivacaine 0.1% at T10-11 followed by 25 mcg fentanyl, and 5 mg Isobaric Ropivacaine 0.5% whereas patients in Group B received 1.5 ml (7.5 mg) Isobaric levo Bupivacaine 0.5% and 25 mcg fentanyl at T8-T10. Patients in both the groups were compared for incidence of shoulder tip pain and Hemodynamic stability. Results: Both techniques achieved satisfactory anaesthesia quality, with similar results in surgical anaesthesia onset. Average surgical duration was 45-75 minutes with average of 60 mins with longer durations in two cases common to both the groups. In group R there was there was no bradycardia or hypotension recorded more than 10% of preinduction vitals. Whereas in group B 2 patients had bradycardia and hypotension more than 10% of preinduction vitals. Conclusions: The T10-11 technique using low-dose (6 mg) hypobaric ropivacaine and isobaric Ropivacaine appears to be superior in terms of shoulder tip pain, and hemodynamic stability compared to the T8-T10 technique using isobaric levo-Bupivacaine alone in higher dose.
背景：以前的许多研究都使用等压/高压布比卡因或罗哌卡因和阿片类药物进行胸椎或腰椎麻醉，用于腹腔镜胆囊切除术，报告的结果各不相同。我们的研究主要是解决术中右肩疼痛的发生及其对转为全身麻醉的潜在影响：这是一项前瞻性对比病例系列研究，其中包括 70 名计划接受择期腹腔镜胆囊切除术的患者。R组患者在T10-11时接受1毫升（1毫克）0.1%低压罗哌卡因，随后使用25微克芬太尼和5毫克0.5%等压罗哌卡因，而B组患者在T8-T10时接受1.5毫升（7.5毫克）0.5%等压左旋布比卡因和25微克芬太尼。对两组患者的肩尖疼痛发生率和血液动力学稳定性进行了比较：结果：两种技术都达到了令人满意的麻醉质量，手术麻醉起效时间相似。平均手术时间为 45-75 分钟，平均 60 分钟，两组均有两例手术时间较长。在 R 组中，心动过缓或低血压的记录不超过诱导前生命体征的 10%。而在 B 组中，有 2 名患者的心动过缓和低血压超过了诱导前生命体征的 10%：结论：使用低剂量（6 毫克）低压罗哌卡因和等压罗哌卡因的 T10-11 技术在肩尖疼痛和血流动力学稳定性方面似乎优于单独使用高剂量等压左旋布比卡因的 T8-T10 技术。
{"title":"Comparative study of two thoracic segmental spinal anaesthesia techniques for laparoscopic cholecystectomy: low-dose hypobaric ropivacaine and isobaric ropivacaine at T10-11 intervertebral space vs. standard technique using isobaric levo bupivacaine at T8-T10 intervertebral space","authors":"Sachin Nagar, Naresh Paliwal, Robin Lohia, Vivek Saluja, Narender Dutt","doi":"10.18203/2349-3259.ijct20240040","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240040","url":null,"abstract":"Background: Many prior studies have utilized thoracic or lumbar spinal anesthesia with isobaric/hyperbaric bupivacaine or Ropivacaine and opioids for laparoscopic cholecystectomy and have reported variable results. our study is centered around addressing the occurrence of intraoperative right shoulder pain and its potential impact on the need for conversion to general anesthesia.\u0000Methods: This is a prospective comparative case series study in which 70 patients scheduled for elective laparoscopic cholecystectomy were. Patients in Group R received 1 ml (1 mg) of Hypobaric Ropivacaine 0.1% at T10-11 followed by 25 mcg fentanyl, and 5 mg Isobaric Ropivacaine 0.5% whereas patients in Group B received 1.5 ml (7.5 mg) Isobaric levo Bupivacaine 0.5% and 25 mcg fentanyl at T8-T10. Patients in both the groups were compared for incidence of shoulder tip pain and Hemodynamic stability.\u0000Results: Both techniques achieved satisfactory anaesthesia quality, with similar results in surgical anaesthesia onset. Average surgical duration was 45-75 minutes with average of 60 mins with longer durations in two cases common to both the groups. In group R there was there was no bradycardia or hypotension recorded more than 10% of preinduction vitals. Whereas in group B 2 patients had bradycardia and hypotension more than 10% of preinduction vitals.\u0000Conclusions: The T10-11 technique using low-dose (6 mg) hypobaric ropivacaine and isobaric Ropivacaine appears to be superior in terms of shoulder tip pain, and hemodynamic stability compared to the T8-T10 technique using isobaric levo-Bupivacaine alone in higher dose.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139601077","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 : 2024-01-24DOI: 10.18203/2349-3259.ijct20240038
J. M. Gibson, John McCrae, Claire Williams, Paul M. Wilson, Peter Bower, Samantha Dixon
Background: Inclisiran is a cholesterol-lowering small interfering RNA treatment licensed in the UK for lowering low-density lipoprotein cholesterol (LDL-C). VICTORION-Spirit (NCT04807400) is an implementation science study designed to provide evidence for inclisiran implementation within the National Health Service. The aim was to describe the process of patient identification employed in VICTORION-Spirit. Methods: A Phase IIIb, multicentre, randomised controlled study, VICTORION-Spirit is evaluating inclisiran implementation in participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents and elevated LDL-C. Feasibility Assessment and Recruitment System for Improving Trial Efficiency (FARSITE) software utilising natural language search functions identified patients who may benefit from inclisiran. FARSITE searches were performed within Salford, Manchester, Trafford and Bury Clinical Commissioning Groups to identify individuals with elevated LDL-C or total cholesterol and pre-existing cardiovascular disease (CVD) or at risk of ASCVD. Results: FARSITE used ‘total cholesterol >4 mmol/l’ terminology rather than ‘LDL-C’; the former yielded >3 times the number of eligible patients. The search for individuals with pre-existing CVD identified 24,196 people in a population of 560,969 (4.3%); including ‘total cholesterol >4 mmol/l’ identified 10,431 individuals with pre-existing CVD and elevated total cholesterol. Searches for individuals at risk of ASCVD identified 65,457 people, narrowing to 26,580 at risk of ASCVD plus elevated total cholesterol. The most discriminatory SNOMED concept codes and their prevalence within the dataset can inform national approaches to develop similar searches. Conclusions: FARSITE searches employed in VICTORION-Spirit identified a population at risk of ASCVD in Greater Manchester, England, who may benefit from a cholesterol-lowering medication such as inclisiran.
{"title":"Identification of patients at risk of cardiovascular disease in greater Manchester in the VICTORION-Spirit study","authors":"J. M. Gibson, John McCrae, Claire Williams, Paul M. Wilson, Peter Bower, Samantha Dixon","doi":"10.18203/2349-3259.ijct20240038","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240038","url":null,"abstract":"Background: Inclisiran is a cholesterol-lowering small interfering RNA treatment licensed in the UK for lowering low-density lipoprotein cholesterol (LDL-C). VICTORION-Spirit (NCT04807400) is an implementation science study designed to provide evidence for inclisiran implementation within the National Health Service. The aim was to describe the process of patient identification employed in VICTORION-Spirit.\u0000Methods: A Phase IIIb, multicentre, randomised controlled study, VICTORION-Spirit is evaluating inclisiran implementation in participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents and elevated LDL-C. Feasibility Assessment and Recruitment System for Improving Trial Efficiency (FARSITE) software utilising natural language search functions identified patients who may benefit from inclisiran. FARSITE searches were performed within Salford, Manchester, Trafford and Bury Clinical Commissioning Groups to identify individuals with elevated LDL-C or total cholesterol and pre-existing cardiovascular disease (CVD) or at risk of ASCVD.\u0000Results: FARSITE used ‘total cholesterol >4 mmol/l’ terminology rather than ‘LDL-C’; the former yielded >3 times the number of eligible patients. The search for individuals with pre-existing CVD identified 24,196 people in a population of 560,969 (4.3%); including ‘total cholesterol >4 mmol/l’ identified 10,431 individuals with pre-existing CVD and elevated total cholesterol. Searches for individuals at risk of ASCVD identified 65,457 people, narrowing to 26,580 at risk of ASCVD plus elevated total cholesterol. The most discriminatory SNOMED concept codes and their prevalence within the dataset can inform national approaches to develop similar searches.\u0000Conclusions: FARSITE searches employed in VICTORION-Spirit identified a population at risk of ASCVD in Greater Manchester, England, who may benefit from a cholesterol-lowering medication such as inclisiran.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139602846","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 : 2024-01-24DOI: 10.18203/2349-3259.ijct20240042
Bedia Guler, Aysel Gurkan
Background: Patients undergoing surgery are at risk of developing pressure injuries because they remain immobile and in a fixed position on the operating table for a long time under anesthesia. Prevention of surgery-induced pressure injuries is the best strategy and requires risk assessment and timely implementation of preventive interventions. This trial aims to evaluate the effect of positioning in a different position pre-operatively and post-operatively than the position adopted during surgery on pressure injuries. Methods: This trial was designed as a prospective randomized controlled study. Participants meeting the inclusion criteria will be assigned to the intervention or control groups using a random number generator. The participants in the intervention group will be placed in different positions than their surgical position during the night before surgery, and the first 36 h after surgery. The control group will receive only routine care. The groups will be evaluated in terms of pressure injury development for at least 72 h, until discharge. Conclusions: Surgery-induced pressure injuries have important effects on patients, healthcare professionals, and healthcare organizations. Current guidelines recommend that patients be positioned in a different position preoperatively and postoperatively than the surgical position to redistribute the pressure generated during surgery. There is a need for well-designed, comprehensive studies to investigate the effectiveness of this weak evidence-level recommendation. This trial will provide valuable evidence to inform clinical practice, guide surgical nurses, and allow evaluation of the effects of this intervention. Trial registration: Clinical trials registration number NCT05549830
{"title":"Effect of different positioning before, during and after surgery on pressure injury: a randomized controlled trial protocol","authors":"Bedia Guler, Aysel Gurkan","doi":"10.18203/2349-3259.ijct20240042","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240042","url":null,"abstract":"Background: Patients undergoing surgery are at risk of developing pressure injuries because they remain immobile and in a fixed position on the operating table for a long time under anesthesia. Prevention of surgery-induced pressure injuries is the best strategy and requires risk assessment and timely implementation of preventive interventions. This trial aims to evaluate the effect of positioning in a different position pre-operatively and post-operatively than the position adopted during surgery on pressure injuries.\u0000Methods: This trial was designed as a prospective randomized controlled study. Participants meeting the inclusion criteria will be assigned to the intervention or control groups using a random number generator. The participants in the intervention group will be placed in different positions than their surgical position during the night before surgery, and the first 36 h after surgery. The control group will receive only routine care. The groups will be evaluated in terms of pressure injury development for at least 72 h, until discharge.\u0000Conclusions: Surgery-induced pressure injuries have important effects on patients, healthcare professionals, and healthcare organizations. Current guidelines recommend that patients be positioned in a different position preoperatively and postoperatively than the surgical position to redistribute the pressure generated during surgery. There is a need for well-designed, comprehensive studies to investigate the effectiveness of this weak evidence-level recommendation. This trial will provide valuable evidence to inform clinical practice, guide surgical nurses, and allow evaluation of the effects of this intervention.\u0000Trial registration: Clinical trials registration number NCT05549830","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139601311","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 : 2024-01-24DOI: 10.18203/2349-3259.ijct20240039
S. Chatio, N. Ansah, E. Nonterah, Oscar Bangre, D. Awuni, Irene Kuwolamo, Victor Asoala, Patrick Ansah
Background: Several COVID-19 vaccines were developed and are being tested to find effective vaccine to control the COVID-19 pandemic. The Navrongo health research centre was engaged to conduct trials on the safety and efficacy of some of the COVID-19 vaccines to inform policy in Ghana. This study explored perceptions and willingness to participate in the COVID-19 vaccine trials that were conducted in the Kassena-Nankana districts of Northen Ghana. Methods: This study used qualitative research approach where 10 focus group discussions and 30 in-depth interviews were conducted with participants. The data were coded into themes using QSR NVivo 12 software before thematic analysis. Results: The majority of participants perceived that the COVID-19 vaccine trial was a good initiative, which had helped people to get access to the vaccines to boost their immunity against the virus. However, some participants felt that it was not appropriate for NHRC to conduct the trials because of the perceived risks associated with the vaccines. Most participants said they were ready to participate in the trials if they were invited with many of them mentioning good health and compensation as the main factors that could influence their decision. Nonetheless, a good number of them maintained that they were not ready to participate because of perceived risks resulting from receiving the COVID-19 vaccines. Conclusion: Our recommendation is that effective community engagement strategies by researchers such as collaborating with key community leaders, to actively get involved during community education prior to conducting clinical trials, could improve understanding and participation.
{"title":"Community perceptions and willingness to participate in COVID-19 vaccine trials: a qualitative study in Northern Ghana","authors":"S. Chatio, N. Ansah, E. Nonterah, Oscar Bangre, D. Awuni, Irene Kuwolamo, Victor Asoala, Patrick Ansah","doi":"10.18203/2349-3259.ijct20240039","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240039","url":null,"abstract":"Background: Several COVID-19 vaccines were developed and are being tested to find effective vaccine to control the COVID-19 pandemic. The Navrongo health research centre was engaged to conduct trials on the safety and efficacy of some of the COVID-19 vaccines to inform policy in Ghana. This study explored perceptions and willingness to participate in the COVID-19 vaccine trials that were conducted in the Kassena-Nankana districts of Northen Ghana.\u0000Methods: This study used qualitative research approach where 10 focus group discussions and 30 in-depth interviews were conducted with participants. The data were coded into themes using QSR NVivo 12 software before thematic analysis.\u0000Results: The majority of participants perceived that the COVID-19 vaccine trial was a good initiative, which had helped people to get access to the vaccines to boost their immunity against the virus. However, some participants felt that it was not appropriate for NHRC to conduct the trials because of the perceived risks associated with the vaccines. Most participants said they were ready to participate in the trials if they were invited with many of them mentioning good health and compensation as the main factors that could influence their decision. Nonetheless, a good number of them maintained that they were not ready to participate because of perceived risks resulting from receiving the COVID-19 vaccines.\u0000Conclusion: Our recommendation is that effective community engagement strategies by researchers such as collaborating with key community leaders, to actively get involved during community education prior to conducting clinical trials, could improve understanding and participation.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139600951","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 : 2024-01-24DOI: 10.18203/2349-3259.ijct20240043
Natalie G. McGowan, Judy H. Zhong, L. Trasande, Jason Hellmann, Sean P. Heffron
Background: Low-dose aspirin is ineffective for primary prevention of cardiovascular events in people with body weight greater than 70kg. While the prevalent explanation for this is reduced platelet cyclooxygenase-1 (COX-1) inhibition at higher body weights, supporting data are limited, thereby demanding further investigation of the reason(s) underlying this observation. We propose that aspirin-mediated cyclooxygenase-2 (COX-2) acetylation and the resulting synthesis of 15-epi-lipoxin A4, a specialized pro-resolving mediator, is suboptimal in higher weight individuals, which may contribute to the clinical trial findings. Methods: To test this hypothesis, we are conducting a double-blind, placebo-controlled, randomized, mechanistic crossover trial. Healthy men and women exhibiting a wide range of body weights take 81mg aspirin and 325mg aspirin for 3 weeks each, following 3-week placebo run-in and wash-out phases. Our target sample size is 90 subjects, with a minimum of 72 completing all visits estimated to be necessary to achieve power adequate to test our primary hypothesis. Our primary endpoint is the difference in change in plasma 15-epi-lipoxin A4 occurring with each dose of aspirin. Secondary endpoints include lipid mediator profiles, serum bioactive lipid profiles, and other endpoints involved in the resolution of vascular inflammation. Conclusions: Study enrollment began in November 2021 and is ongoing. The results of this study will improve our understanding of the mechanisms underlying aspirin’s role(s) in the prevention of adverse cardiovascular outcomes. They may also lead to additional studies with the potential to inform dosing strategies for patients based on body weight. Trial registration: This trial is registered with ClinicalTrials.gov identifier NCT04697719.
{"title":"A randomized, placebo-controlled crossover trial to assess the influence of body weight on aspirin-triggered specialized pro-resolving mediators: protocol for the discover study","authors":"Natalie G. McGowan, Judy H. Zhong, L. Trasande, Jason Hellmann, Sean P. Heffron","doi":"10.18203/2349-3259.ijct20240043","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240043","url":null,"abstract":"Background: Low-dose aspirin is ineffective for primary prevention of cardiovascular events in people with body weight greater than 70kg. While the prevalent explanation for this is reduced platelet cyclooxygenase-1 (COX-1) inhibition at higher body weights, supporting data are limited, thereby demanding further investigation of the reason(s) underlying this observation. We propose that aspirin-mediated cyclooxygenase-2 (COX-2) acetylation and the resulting synthesis of 15-epi-lipoxin A4, a specialized pro-resolving mediator, is suboptimal in higher weight individuals, which may contribute to the clinical trial findings.\u0000Methods: To test this hypothesis, we are conducting a double-blind, placebo-controlled, randomized, mechanistic crossover trial. Healthy men and women exhibiting a wide range of body weights take 81mg aspirin and 325mg aspirin for 3 weeks each, following 3-week placebo run-in and wash-out phases. Our target sample size is 90 subjects, with a minimum of 72 completing all visits estimated to be necessary to achieve power adequate to test our primary hypothesis. Our primary endpoint is the difference in change in plasma 15-epi-lipoxin A4 occurring with each dose of aspirin. Secondary endpoints include lipid mediator profiles, serum bioactive lipid profiles, and other endpoints involved in the resolution of vascular inflammation.\u0000Conclusions: Study enrollment began in November 2021 and is ongoing. The results of this study will improve our understanding of the mechanisms underlying aspirin’s role(s) in the prevention of adverse cardiovascular outcomes. They may also lead to additional studies with the potential to inform dosing strategies for patients based on body weight.\u0000Trial registration: This trial is registered with ClinicalTrials.gov identifier NCT04697719.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139601935","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 : 2024-01-24DOI: 10.18203/2349-3259.ijct20240041
Benjamin Daniels, Daniel Rogger, Meyhar Mohammed, Katre Vaarsi, Kevin Croke
Background: Estonia’s aging population faces an increasing burden of non-communicable diseases (NCDs) and a growing population suffers with multiple chronic conditions. These changes have reduced well-being and quality of life for many older Estonians, while increasing the use of high cost specialist and emergency care. In response, the Estonia Health Insurance Fund (EHIF) is working to support primary care physicians to improve care for complex patients with multiple chronic conditions. A new EHIF program, Enhanced Care Management (ECM), trains family physicians to identify complex patients, co-develop proactive care plans with them, and conduct more active outreach and management of these patients. Methods: In this protocol we describe a randomized controlled trial, developed in partnership with EHIF, to evaluate the impact of ECM training for physicians. The RCT enrolled a randomly selected 97 family physicians out of the 786 family physicians practicing in Estonia. Among those physicians’ 6,739 ECM-eligible patients, 2,389 patients were randomly selected for enrolment into the ECM program. Results: Using administrative records, we evaluated the effects of ECM enrolment on: (1) health care utilization; (2) provider management of tracer conditions; and (3) markers of quality of care such as hospital admission for primary health care-sensitive conditions. Conclusions: This protocol presents a pre-specified analysis plan for this evaluation of Estonia’s ECM program. Trial registration: First registered with the American Economics Association, AEARCTR-0003661. Registered May 1, 2019. Retrospective secondary registration with www.clinicaltrials.gov P169891. Registered April 26, 2023.
{"title":"Evaluation of Estonia’s enhanced care management program: protocol for a cluster randomized trial","authors":"Benjamin Daniels, Daniel Rogger, Meyhar Mohammed, Katre Vaarsi, Kevin Croke","doi":"10.18203/2349-3259.ijct20240041","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240041","url":null,"abstract":"Background: Estonia’s aging population faces an increasing burden of non-communicable diseases (NCDs) and a growing population suffers with multiple chronic conditions. These changes have reduced well-being and quality of life for many older Estonians, while increasing the use of high cost specialist and emergency care. In response, the Estonia Health Insurance Fund (EHIF) is working to support primary care physicians to improve care for complex patients with multiple chronic conditions. A new EHIF program, Enhanced Care Management (ECM), trains family physicians to identify complex patients, co-develop proactive care plans with them, and conduct more active outreach and management of these patients.\u0000Methods: In this protocol we describe a randomized controlled trial, developed in partnership with EHIF, to evaluate the impact of ECM training for physicians. The RCT enrolled a randomly selected 97 family physicians out of the 786 family physicians practicing in Estonia. Among those physicians’ 6,739 ECM-eligible patients, 2,389 patients were randomly selected for enrolment into the ECM program.\u0000Results: Using administrative records, we evaluated the effects of ECM enrolment on: (1) health care utilization; (2) provider management of tracer conditions; and (3) markers of quality of care such as hospital admission for primary health care-sensitive conditions.\u0000Conclusions: This protocol presents a pre-specified analysis plan for this evaluation of Estonia’s ECM program.\u0000Trial registration: First registered with the American Economics Association, AEARCTR-0003661. Registered May 1, 2019. Retrospective secondary registration with www.clinicaltrials.gov P169891. Registered April 26, 2023.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139601473","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 : 2023-12-27DOI: 10.18203/2349-3259.ijct20233941
S. Karanasios, Dimitra Mertyri, Fotis Karydis
Background: The thumb carpometacarpal osteoarthritis (CMC-OA) is a common musculoskeletal condition of the hand causing increased pain and significant disability. Although different modes of exercises are usually prescribed during the management of the condition, the evidence for their effectiveness is sparse. The aim of this protocol is to investigate through a systematic review the effectiveness of exercises compared with other non-surgical interventions in reducing pain and improving function in the management of the thumb CMC-OA. Methods: We will conduct this systematic review following the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines. PubMed, CINAHL, EMBASE, PEDro, ScienceDirect, Cochrane Library, Grey literature databases and clinical trial registries will be searched. Two reviewers will independently evaluate the retrieved results. Subsequently, data extraction of the eligible trials will be conducted by two independent researchers. We will use the grading of recommendations assessment, development, and evaluation (GRADE) approach to assess the certainty of evidence. Conclusions: This systematic review will provide evidence for the clinical benefits of exercises compared with other conservative interventions in the management of patients with thumb CMC-OA. Trial registration: PROSPERO registration number is CRD42023461505.
{"title":"The effectiveness of exercises in patients with thumb carpometacarpal osteoarthritis: a study protocol for a systematic review and meta-analysis","authors":"S. Karanasios, Dimitra Mertyri, Fotis Karydis","doi":"10.18203/2349-3259.ijct20233941","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20233941","url":null,"abstract":"Background: The thumb carpometacarpal osteoarthritis (CMC-OA) is a common musculoskeletal condition of the hand causing increased pain and significant disability. Although different modes of exercises are usually prescribed during the management of the condition, the evidence for their effectiveness is sparse. The aim of this protocol is to investigate through a systematic review the effectiveness of exercises compared with other non-surgical interventions in reducing pain and improving function in the management of the thumb CMC-OA. Methods: We will conduct this systematic review following the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines. PubMed, CINAHL, EMBASE, PEDro, ScienceDirect, Cochrane Library, Grey literature databases and clinical trial registries will be searched. Two reviewers will independently evaluate the retrieved results. Subsequently, data extraction of the eligible trials will be conducted by two independent researchers. We will use the grading of recommendations assessment, development, and evaluation (GRADE) approach to assess the certainty of evidence. Conclusions: This systematic review will provide evidence for the clinical benefits of exercises compared with other conservative interventions in the management of patients with thumb CMC-OA. Trial registration: PROSPERO registration number is CRD42023461505.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139153325","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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