Medicine, case reports and study protocols最新文献

{"title":"Efficacy and safety of Xiang-Sha-Liu-Jun-Zi (XSLJZ) for treatment of Semaglutide-induced gastrointestinal side effects: Study protocol for a multicentre, randomized, open-label trial","authors":"Meixi Liu, Xianliang Qiu, Shunlian Fu, Yuting Tian, Wen Li, Qing Li, Qiu Chen","doi":"10.1097/md9.0000000000000297","DOIUrl":"https://doi.org/10.1097/md9.0000000000000297","url":null,"abstract":"Background: Semaglutide is a newly approved glucagon-like peptide 1 receptor agonist(GLP-1 RA), significantly reducing HbA1c and body weight. However, it is associated with an increased incidence of gastrointestinal adverse events. Xiang-Sha-Liu-jun-Zi (XSLJZ), is a classic traditional Chinese medicine (TCM) formula with the effects of modulating gastrointestinal disturbance. This study aims to evaluate the clinical efficacy and safety of the XSLJZ for treatment of Semaglutide-induced gastrointestinal side effects. Methods: This is a multicentre, randomized, open-label trial. The trial included a run-in period within 2 weeks, a 4-week treatment period, and another 4 weeks after the end of the experimental phase. Patients who have Gastrointestinal Adverse Reactions during the run-in period will be randomly divided (1:1) into 2 groups. The primary outcome measures were changes in scores on the Gastrointestinal System Rating Scale(GSRS), the duration of individual gastrointestinal adverse events. The secondary outcomes were TCM syndrome score, changes in glycaemic excursions, homeostatic model assessment 2-B (HOMA2-B)and homeostatic model assessment 2-insulin resistance(HOMA2-IR), glucagon, C-peptide, plasma lipids, Anthropometric parameters: body weight, body mass index, waist-hip circumference, waist-hip ratio. Discussion: The results of this trial will provide initial evidence for the use of XSLJZ as an alternative and complementary intervention to manage Semaglutide-induced gastrointestinal side effects.","PeriodicalId":493673,"journal":{"name":"Medicine, case reports and study protocols","volume":"44 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135809352","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}

{"title":"Electrocautery ablation of high-grade anal intraepithelial lesions: A protocol for a clinical trial","authors":"Naokatsu Ando, Daisuke Mizushima, Hiroshi Kitamura, Daisuke Shiojiri, Takato Nakamoto, Misao Takano, Takahiro Aoki, Shinichi Oka, Hiroyuki Gatanaga","doi":"10.1097/md9.0000000000000299","DOIUrl":"https://doi.org/10.1097/md9.0000000000000299","url":null,"abstract":"Background: Anal cancer is predominantly caused by the human papillomavirus. The use of high-resolution anoscopy (HRA) for screening, followed by appropriate therapeutic interventions, is progressively being acknowledged as a standardized procedure to manage anal cancer. Commonly, lesions identified as potentially high-grade squamous intraepithelial lesions undergo biopsy and receive treatment if classified as anal intraepithelial neoplasia (AIN) grade 2 or 3. Numerous studies have underscored the substantial efficacy of electrocautery ablation in treating grade 2 or 3 AIN. However, relapse within and outside the targeted areas after intervention is a clinical problem. Postintervention recurrence within and beyond the initial targeted areas presents a significant clinical challenge. Most healthcare facilities in Japan do not offer electrocautery ablation. An initial pilot study demonstrated the safety and efficacy of electrocautery ablation. Consequently, we aimed to scrutinize the effectiveness and safety profile of electrocautery ablation procedures using a larger sample size. Methods: This single-arm, open-label intervention trial aims to examine the efficacy and safety associated with electrocautery ablative treatments by utilizing high-frequency medical instruments. The cohort will comprise patients diagnosed with grade 2 or 3 AIN who will then undergo ablative treatments. Subsequent follow-ups will be scheduled at intervals of 6, 12, 24, and 36 months posttreatment, incorporating HRA-guided sextant biopsies to monitor disease progression. To minimize the chances of overlooking the lesions before and after the treatment phase, systematic HRA-guided sextant biopsies will be performed. Within the scope of this study, a sextant biopsy necessitates a minimum of 6 biopsy procedures in various directions, irrespective of any abnormalities detected during HRA inspections. The principal objective of this study is to ascertain the 12-month recurrence rate, with secondary objectives focusing on monitoring adverse events and recurrence rates at the 6-, 24-, and 36-month time points. Conclusion: This study aims to provide substantial data concerning the effectiveness and safety parameters of electrocautery ablation as a viable alternative treatment for patients with grade 2 or 3 AIN.","PeriodicalId":493673,"journal":{"name":"Medicine, case reports and study protocols","volume":"137 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135809350","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}

{"title":"Anisodine hydrobromide injection in the treatment of acute ischemic stroke: A protocol for systematic review and meta-analysis","authors":"Yunlu Liu, Yang Wang, Feng Wan","doi":"10.1097/md9.0000000000000298","DOIUrl":"https://doi.org/10.1097/md9.0000000000000298","url":null,"abstract":"Background: Acute ischemic stroke (AIS) is a common disease of the central nervous system, with high mortality, and disability rates. Anisodine hydrobromide (Ani) injection has been used clinically for the treatment of AIS in China. However, no systematic review and meta-analysis have provided rigorous evidence for the clinical use of Ani injection in the treatment of AIS. This study aims to assess the efficacy and safety of Ani injection in the treatment of AIS. Methods: Following databases will be searched to identify eligible articles: CNKI, VIP, Wanfang, Chinese Biomedical Literature Database, EMBASE, PubMed, Cochrane, and Web of Science. All databases will be searched from their inception to May, 2023. RevMan software will be used for data analysis. Results: The results from meta-synthesis and descriptive analysis of National Institute of Health Stroke Scale, modified Rankin scale, Barthel Index, CT parameters, clinical efficacy rate, and adverse reactions of included articles will provide latest evidence. Conclusion: Findings of this study will provide a solid evidence-based basis for the rational and precise application of Ani injection for the treatment of AIS.","PeriodicalId":493673,"journal":{"name":"Medicine, case reports and study protocols","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135809351","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}

{"title":"Efficacy of Lactococcus lactis strain Plasma on clearance of anal HPV infection in men who have sex with men: A single-center, double-blinded, randomized placebo-controlled trial (CLEAR HPV study)","authors":"Daisuke Mizushima, Misao Takano, Naokatsu Ando, Hiroshi Kitamura, Daisuke Shiojiri, Takato Nakamoto, Takahiro Aoki, Koji Watanabe, Yosuke Shimizu, Yukari Uemura, Hiroyuki Gatanaga, Shinichi Oka","doi":"10.1097/md9.0000000000000300","DOIUrl":"https://doi.org/10.1097/md9.0000000000000300","url":null,"abstract":"Background: Anal cancer is a human papillomavirus-related cancer; specifically, it is preceded by high-grade squamous intraepithelial lesions, which are less likely to regress spontaneously than low-grade intraepithelial lesions. Although most human papillomavirus (HPV) infections are thought to clear spontaneously, anal HPV infection persists, especially in people living with HIV. Preliminary results from a recent small randomized placebo-controlled trial of oral bacteriotherapy using a high dose of probiotics demonstrated clearance of anal high-risk HPV (hr-HPV) infection and lower onset of new high-grade squamous intraepithelial lesions among people living with HIV. Lactococcus lactis strain Plasma is a lactic acid bacterium directly activating plasmacytoid dendritic cells and inducing release of type I and III interferons via Toll-like receptor 9 stimulation. Based on these findings, oral bacteriotherapy with LC-plasma may contribute to clearing anal hr-HPV infection and reducing anal precancerous lesions by activating innate and acquired immune responses. This randomized placebo-controlled trial aims to investigate the efficacy and safety of LC-plasma therapy in clearing anal hr-HPV infection and reducing anal precancerous lesions among men who have sex with men with or without HIV infection. Methods: Participants with anal hr-HPV infection will be included and receive test capsules. A total of 150 patients will be included in the intervention group with follow-up, which will consist of HPV genotype test, cytology by anal pap smear, and biopsy with high-resolution anoscopy. The primary endpoint will be the clearance rate of the hr-HPV genotype infection at the anal site at 180 days. The secondary endpoints will be changes in anal epithelial neoplasia detected using high-resolution anoscopy at 180 days; change in abnormal cytology by anal pap smear at 180 days; change in hr-HPV genotype at the anal site at 180 days; change or percentage change in peripheral blood CD4 positive T-lymphocyte numbers in HIV-infected participants at 180 days; changes in quantitative hepatitis B surface antigen levels at 180 days in the HBV-infected participants; and adherence to the study drugs. Conclusion: This randomized controlled study will provide data on the efficacy and safety of LC-plasma as a treatment for anal HPV infection and grade 2 or 3 anal intraepithelial neoplasia.","PeriodicalId":493673,"journal":{"name":"Medicine, case reports and study protocols","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135850314","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}

{"title":"Immediate versus MOdified DElayed coloanal anastomosis after total mesorectal excision: A protocol for a randomized controlled trial","authors":"Hani Bendib, Abdelkrim Anou, Nabil Djelali, Hind Oukrine, Hassan Alikhodja, Abdelghani Azzouz, Azeddine Djennaoui, Chemseddine Chekman","doi":"10.1097/md9.0000000000000286","DOIUrl":"https://doi.org/10.1097/md9.0000000000000286","url":null,"abstract":"Background: Immediate coloanal anastomosis (ICA) remains the standard technique for restoring the digestive tract after proctectomy for low rectal cancer. Often, it requires a temporary diversion stoma, thus increasing the risk of complications. Recent data have shown a great potential of the delayed coloanal anastomosis both in decreasing anastomosis morbidity and in avoiding ileostomy to the patients. More recently, a modified delayed coloanal anastomosis (mDCA) has been described and seems to have promising results. This study aims to determine whether mDCA is non-inferior to ICA. Methods: The IMODE trial is a randomized, controlled, non-inferiority trial designed to enroll 70 adults with mid or low rectal cancer. Participants are randomized to ICA or mDCA. The primary endpoint is the anastomotic fistulas rate at 6 months. Conclusions: The mDCA can constitute an interesting modality to restore the digestive tract following proctectomy for mid and low rectal cancer; this by decreasing the morbidity of the coloanal anastomosis on the one hand and by avoiding ileostomy on the other hand.","PeriodicalId":493673,"journal":{"name":"Medicine, case reports and study protocols","volume":"60 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134994380","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}

{"title":"Effectiveness of education on linear programmed dietary plan using locally available food on energy intake among HIV-infected children aged 2 to 5 years in Simiyu region: A cluster randomized control trial protocol","authors":"Heriet Carin, Leonard Katalambula, Mariam Munyogwa, Kihulya Mageda, Halidi Lyeme","doi":"10.1097/md9.0000000000000290","DOIUrl":"https://doi.org/10.1097/md9.0000000000000290","url":null,"abstract":"Background: Most of human immunodeficiency virus (HIV) infected children have decreased energy intake due to loss of appetite which resulted in weight loss. The diets of many HIV-infected children do not meet the recommended levels of energy intake required. However, caregivers with poor nutrition knowledge are more likely to feed their children with low-quality and diverse foods and at a lower frequency than recommended. This study aims to test the effectiveness of education on the linear programmed dietary plan using locally available food on energy intake of HIV-infected children in Tanzania mainland. Methods: The study will be a cluster randomized control trial study designed with both intervention and control arms and will use a quantitative approach. Care and treatment center will be the unit of randomization. The study will involve 200 asymptomatic HIV-infected children aged 2 to 5 years. The children will be randomly allocated into the intervention and control arm. The intervention will be implemented for 3 months. Participants from all groups will be assessed nutrition knowledge and attitude as well as 24-hour recall at baseline and end line. Education on how to use the energy-dense dietary plan developed by using linear programming techniques will be provided to the intervention group. The main outcome measures will be changes in knowledge, attitude, and energy intake in the intervention group compared with the control group. An unpaired t test will be used to establish the effectiveness of the intervention. A P value of less than .05 will be considered statistically significant. Discussion: The results of this study will provide evidence of the effectiveness of linear programmed dietary plan education on energy intake in community settings of rural Tanzania. It will form the basis for strengthening diet intake among HIV-infected children to improve energy intake using locally available food.","PeriodicalId":493673,"journal":{"name":"Medicine, case reports and study protocols","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134995071","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}

{"title":"Effectiveness of respiratory training in home-based pulmonary rehabilitation for elderly patients with stable COPD: Study protocol for a randomized controlled trial","authors":"Xiaoyu Shen, Jianguo Zhong, Cuihua Shan, Dailiang Zhang","doi":"10.1097/md9.0000000000000291","DOIUrl":"https://doi.org/10.1097/md9.0000000000000291","url":null,"abstract":"Introduction: Chronic Obstructive Pulmonary Disease (COPD) brought a heavy risk of morbidity, hospital admission, and death. Respiratory training as an important part of pulmonary rehabilitation has not been validated in home-based elderly patients with stable COPD. This study aims to demonstrate the efficacy of a standardized respiratory training in home-based elderly patients with stable COPD. Methods: The prospective, randomized controlled trial will be designed and conduced in the Second Affiliated Hospital of Chengdu Medical College (China National Nuclear Corporation 416 Hospital),China. Eligible patients with stable COPD will be randomly divided into experimental group and control group, both of the 2 groups will carry out regular home-based pulmonary rehabilitation for 3 months, additionally experimental group will receive a standardized respiratory training for 3 months. The primary outcome is the pulmonary function test before and after 3 months exercises. Discussion: The study will provide a objective basis for the use of respiratory training in home-based pulmonary rehabilitation for elderly patients with stable COPD.","PeriodicalId":493673,"journal":{"name":"Medicine, case reports and study protocols","volume":"49 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134994532","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}

{"title":"Moyamoya disease mimicking primary central nervous system vasculitis: A case report","authors":"Ryo Morikawa, Junichiro Suzuki, Noriyoshi Nakai, Syuntaro Takasu, Takayuki Itoh, Yasuhiro Ito","doi":"10.1097/md9.0000000000000287","DOIUrl":"https://doi.org/10.1097/md9.0000000000000287","url":null,"abstract":"Rationale: Both Moyamoya disease (MMD) and primary central nervous system vasculitis (PCNSV) cause cerebrovascular stenosis resulting in similar ischemic neurological events, although therapeutic approaches are distinct from each other. High-resonance vascular wall imaging (HRVWI) with contrast-enhanced magnetic resonance imaging (MRI) is believed to be useful to differentiate PCNSV from MMD by detecting enhancement of cerebral vascular walls. However, recent studies have reported that the vascular walls of major arteries and superficial cerebral arteries are also enhanced by HRVWI in some MMD cases. Patient concerns: A 40-year-old Chinese woman admitted to our hospital with transient weakness of the right hand for a week. A cerebral infarction of the left frontal lobe was detected by diffusion-weighted brain MRI. Magnetic resonance angiography demonstrated severe stenosis of the left middle cerebral artery (MCA) and extensive vascular narrowing. Magnetic resonance angiography incidentally taken 3 years before admission showed only a mild stenosis at the proximal portion of right MCA with intact left internal carotid artery (ICA) and MCA. Moreover, on HRVWI with contrast-enhanced MRI after admission, the wall of ICA was strongly enhanced, and the superficial cerebral arteries were also highly enhanced, which initially suggested PCNSV. Despite these findings, reticular blood vessels were confirmed by digital subtraction angiography, and p.R4810K polymorphism in the ring finger protein 213 gene was detected. Diagnosis: Based on these result, the patient was diagnosed with MMD. Interventions: Bypass surgery was performed. Outcomes: Ischemic events have never been experienced since surgery. Lessons: Our MMD case demonstrated marked asymmetrical progression of cerebral artery stenosis, and enhanced vascular walls of ICA and superficial cerebral arteries by HRVWI, which made differential diagnosis from PCNSV difficult. Genetic analysis of SNP in the ring finger protein 213 gene should be performed to rule out MMD to avoid misdiagnosis of PCNSV particularly in Asian population.","PeriodicalId":493673,"journal":{"name":"Medicine, case reports and study protocols","volume":"178 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134994918","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}

{"title":"Propiverine induced pure visual hallucinations without cognitive impairment: A case report","authors":"Mahmut Selçuk","doi":"10.1097/md9.0000000000000294","DOIUrl":"https://doi.org/10.1097/md9.0000000000000294","url":null,"abstract":"Rationale: Propiverine is believed to have fewer adverse effects on the central nervous system than other anticholinergic medications since it penetrates the blood–brain barrier less deeply. In daily practice, no evidence links propiverine use to neuropsychiatric adverse effects. To our knowledge, this is the first report of psychotic symptoms being linked to propiverine use. Patient concerns: A urologist prescribed 30 mg/day of propiverine capsules to a 62-year-old male patient who complained of urine incontinence and visited the urology outpatient clinic. The patient returned to the urology outpatient clinic a week later because he was experiencing visual hallucinations. Interventions: In the psychiatry outpatient clinic, the patient was conscious, cooperative, and oriented during the mental state examination. He spoke about daylong visual hallucinations that included visions of numerous animals and geometric forms. His mood was somewhat anxious as a result of these images, which started appearing 3 days after taking the propiverine capsule and persisted for 4 days. His cognitive functions were normal. Physical examination, blood chemistry, endocrinology, and brain exams using cranial tomography and electroencephalogram revealed no abnormalities. We advised stopping the medication since visual hallucinations started soon after taking propiverine capsules. Outcomes: After discontinuation of propiverine capsules, the patient’s visual hallucinations disappeared. Lessons: Health practitioners should be aware that adverse effects like visual hallucinations can happen even with anticholinergic medications like propiverine that have a low level of penetration into the blood–brain barrier.","PeriodicalId":493673,"journal":{"name":"Medicine, case reports and study protocols","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134995519","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}