Archives of Clinical Trials最新文献

{"title":"Assessment of the role of lipoprotein a level in the development of cardiovascular diseases","authors":"Vishneva E, Vishneva K","doi":"10.33425/2768-4598.1011","DOIUrl":"https://doi.org/10.33425/2768-4598.1011","url":null,"abstract":"A comparative trial within 2 groups of patients with cardiovascular diseases who have high and normal levels of lipoprotein (a) was conducted to determine the link between high levels of Lp (a) and the nature of the development of cardiovascular events. According to the results of the study, conclusions about the significance of the level of Lp(a), as well as hypolipidemic therapy in patients with cardiovascular pathology were made. The features of the population of patients with an expected increase in Lp(a) and the predominance of lesions of the brachiocephalic arteries among individuals with increased Lp(a) were revealed. Hypolipidemic statin therapy with a passable correction of the lipid spectrum does not always allow to control the increase in Lp(a)","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125938344","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 Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: Clinical Randomized Trial","authors":"Marcelo Rudelir","doi":"10.33425/2768-4598.1012","DOIUrl":"https://doi.org/10.33425/2768-4598.1012","url":null,"abstract":"Objective: The purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than treatment with alprazolam alone. Description: We have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments than those who did not. The objective is to compare the efficacy of a pharmacological monotherapy (alprazolam), which is one of the options for the pharmacological treatment of panic disorder, with another treatment such as the combination of aerobic physical exercise and alprazolam, and to determine if this combination results in a better therapeutic response. Methods: 150 outpatients with panic disorder were randomly assigned to 4 mg of alprazolam or 4 mg of alprazolam associated to a programmed aerobic exercise reaching a heart rate between 50% and 75% of their maximum. Both groups completed their treatments in 12 weeks and were scored using the Hamilton Anxiety Rating Scale (H.A.R.S./14) and the Clinical Global Impression (CGI) before the study and during weeks 1, 4, 8, and 12. Patients assigned to the pharmacological plan received 4 mg alprazolam daily for 12 weeks. Two weeks after the first interview they had their first baseline psychiatric control, where all the patients were evaluated. Then, at the same visit, all the patients were prescribed 4 mg of alprazolam. The dose was gradually increased from 1 to 4 mg throughout the first week of treatment. The test was repeated during weeks 2, 4, 8 and 12. Patients assigned to exercise had to pass an ergometric test to determine their functional capacity expressed in METs for future indication of exercise. Two weeks after the first interview they had their first baseline psychiatric control and at the same time a 4 mg dose of alprazolam was prescribed, gradually increased from 1 to 4 mg along the first week of treatment. The test was repeated during weeks 2, 4, 8 and 12. Then they followed a protocolized aerobic exercise plan for this study for 12 weeks. The type of exercise consisted of a brisk walk for 30 minutes divided into stages. After each stage, the patient must control his own heart frequency, which must be between 50 and 75% of its maximum to ensure an aerobic condition (according yo American Cardiological Association criteria) Results: 106 of the 150 selected patients managed to fulfill both treatments: 51 for the alprazolam + exercise group (dropout rate 32%) and 55 for the alprazolam group (dropout rate 27 %). The group treated with alprazolam + exercise experienced a significant improvement (p < 0.001) respect to the group treated only with alprazolam, reaching lower Hamilton Anxiety Scale scores (4,16 ± 1,06 and 8.57 ± 2,39 respectively) and Global Clinical Evaluation scores (Severity 1,86 ± 0,60 and 2.71 ± 0,62 ; Improvement 2,19 ± 0,49 and 2,87 ± 0,63 respectively for each group). Also, ","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133778213","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":"PEGylated COVID-19 vaccines and cell-cell fusion","authors":"A. Sfera, Sarvin Sasannia, Z. Kozlakidis","doi":"10.33425/2768-4598.1015","DOIUrl":"https://doi.org/10.33425/2768-4598.1015","url":null,"abstract":"","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129235109","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":"Effects of physical exercise on sarcopenia after bariatric surgery: Study protocol of a randomized controlled trial","authors":"Cláudia Amaro Santos, A. Raimundo, M. Carvalho, S. Martins","doi":"10.33425/2768-4598.1014","DOIUrl":"https://doi.org/10.33425/2768-4598.1014","url":null,"abstract":"Introduction: Bariatric surgery is the treatment of severe obesity with associated pathologies, with proven evidence in its benefits. By treating overweight allows a better and even reversal of pathologies associated with obesity. Weight loss associated with bariatric surgery is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, which leads us to induce that after bariatric surgery, patients incur an increased risk of sarcopenia. The need for prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the framing of long-term surgical success of bariatric and metabolic surgery. The aim of this randomized clinical trial will be to study the effects of a 16-week supervised exercise intervention program on the prevention of sarcopenia after bariatric surgery Method: This randomized controlled trial study will include 60 patients of both sexes on the waiting list for bariatric surgery and who have subsequently performed the surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity and sedentary behavior will be determined. Results: Assessments will take place in five moments, the surgery, the intervention, the post-intervention, six months after the intervention, twelve months after the intervention.","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"42 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127885669","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":"Treatment of cutaneous photoaging lesions with autologous platelet concentrate","authors":"Yetter Cruz León, I. Trujillo, Yaquelín Luciana Morales Novo, Ángela Rosa Gutiérrez Rojas, Jesús Diego de la Campa, J. L. López Silva, Daymi Serpa Almaguer","doi":"10.33425/2768-4598.1013","DOIUrl":"https://doi.org/10.33425/2768-4598.1013","url":null,"abstract":"Background: Facial aging causes a devastating physical and mental impact on quality of life. Objective: To evaluate the efficacy and safety of autologous platelet concentrate (APC) in the treatment of cutaneous photoaging (SCF). Method: Between March 1, 2017 and March 31, 2021, at the “Hermanos Ameijeiras” hospital, a randomized, single-center, double-blind and controlled clinical trial was carried out in 164 patients with ECF. A group treated with CPA was compared to another treated with fresh autologous plasma (AFP). The treatment was applied monthly for 1 year. Results: Three months after the end of the treatment, there were significant differences between the patients treated with CPA compared to those treated with PFA in terms of the improvement in the degree of photodamage and the degree of satisfaction (p <0.001). All adverse events were of mild intensity, did not imply changes before the intervention and were completely resolved. Conclusions: The autologous platelet concentrate proved to be effective and safe to reduce the signs of skin aging, associated with a high degree of patient satisfaction.","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132131059","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":"A Unified Primary Care Approach for the Management of Insomnia and Confusion Using the Clinical Pathway","authors":"Megumi Kabeya, S. Yuasa, K. Ina, C. Tokoro, Yosuke Kubota, S. Kayukawa","doi":"10.21203/rs.3.rs-955231/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-955231/v1","url":null,"abstract":"\u0000 Background\u0000 Delirium -characterized by an acute or subacute decline in cognitive functioning- and confusion are risk factors for falls and its related injuries. Therefore, we designed a unified clinical pathway to reduce the risk of delirium among hospitalized patients.\u0000Methods\u0000 A unified approach of pharmacotherapy for managing insomnia and confusion, which is subdivided based on the patients’ age (<70 versus ≧70 years) and presence of diabetes mellitus, was implemented in Nagoya Memorial Hospital, Japan. Risk factors for delirium were assessed via a multidisciplinary approach. For older high-risk patients, suvorexant or trazodone was prophylactically prescribed to promote sleep. If delirium occurred, either quetiapine or perospirone was administered prior to the usage of risperidone or haloperidol. The amounts of prescribed sleep inducers and antipsychotic agents were examined. The application rate of the clinical pathway and incidence of falls were compared before and after its introduction.\u0000Results\u0000 The application of a unified approach significantly decreased the prescribed amounts of benzodiazepines and may be associated with the reduced incidence of falls among inpatients.\u0000Conclusions\u0000 A clinical pathway assisted the selection of sleep inducers and antipsychotic agents. This is useful for managing elderly patients safely by preventing delirium and subsequent falls.","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"103 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122973386","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":"A double blind, randomized, placebo-controlled study to evaluate efficacy and safety of “ViraCide” in the management of Corona Virus Disease 2019 (COVID-19)","authors":"Mahir Abduldaim","doi":"10.33425/2768-4598.1010","DOIUrl":"https://doi.org/10.33425/2768-4598.1010","url":null,"abstract":"Introduction: The purpose of this study was to evaluate the safety and efficacy of ViraCide in the management of Corona Virus Disease 2019. Methodology: The study was a randomized, multi center, parallel design, placebo controlled, double blind, clinical trial in patients diagnosed with corona virus disease 2019 with mild or no symptoms and with stable co-morbidities. 118 enrolled subjects were randomized in a 1:1 ratio to either placebo treatment or ViraCide (active treatment). Result: The primary efficacy parameters of National Early Warning Score (NEWS) and 7 point ordinal showed a significantly greater improvement in the active group at the end of the study (P < 0.05). In case of NEWS, in the ViraCide group at visit 3, 74.6 % of the subjects had score of “0” which was higher than the placebo in which only 49.2% showed the reduction. In case of the 7 point ordinal scale, in the active group 76.3 % of the subjects had score of 1 which is significantly higher than that of placebo group which is only 47.5%. Time taken for clinical improvement with respect to negative RT PCR test also showed significant difference in the active v/s placebo group. The mean time taken by patients in the active group to test negative was 5.47 days which was significantly lower than placebo which was 6.97 days. The adverse events rate and severity were comparable in both the groups and no clinically significant adverse event was found in the active or placebo group. Conclusion: The use of ViraCide in mild or asymptomatic COVID-19 patients showed time frame reduction with respect to RT-PCR test, as well as clinical improvement demonstrated by NEWS and 7-point ordinal scale and certain laboratory parameters. Further clinical trials are required to evaluate role of ViraCide in managing COVID-19 and establish its mode of action.","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"127 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127399874","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":"Value of 3T diffusion weighted MRI in comparison with CECT in detection of ovarian cancer and ovarian cancer recurrence","authors":"Härmä Kirsi, Sipola Petri J, Vainio Pauli, Pelkonen Outi, Rautiainen Suvi, Anttila Maarit, R. Vanninen","doi":"10.33425/2768-4598.1006","DOIUrl":"https://doi.org/10.33425/2768-4598.1006","url":null,"abstract":"Purpose: To investigate the value of 3T diffusion weighted magnetic resonance imaging (DW-MRI) compared to contrast enhanced computed tomography (CECT), in the preoperative staging of patients with suspected ovarian cancer (OC) or with suspected recurrence of ovarian cancer (ROC). Materials and methods: Thirty-two women (mean age 65 ± 14) with suspected (n = 23) or recurrent (n = 9) ovarian cancer were included prospectively in a single center study. CECT and abdominal 3T DW-MRI were performed. Both methods were used to independently score the presence of 1) ovarian tumor, 2) peritoneal or omental carcinomatosis, 3) pathological lymph nodes (LN), along with 4) liver parenchymal, 5) liver capsular, 6) diaphragmatic, and 7) extra-abdominal metastases. Findings were scored as: 0=benign, 1=suspicious for malignancy, or 2=definitely malignant. In addition, the lowest ADC values were measured in existing primary tumors. The extent of disease burden and correlation to histopathological findings were analyzed. Results: The mean disease score was higher in DW-MRI than in CT (4.9 ± 2.6 vs. 3.5 ± 2.2, P < 0.001). Compared to CT, DW-MRI depicted more LN (P = 0.001) and diaphragmatic (P = 0.024) lesions. The lowest ADC values were significantly lower in malignant tumors (n = 18) than in benign tumors (n = 5) (0.640 x10-3mm2 /s ± 159 vs. 0.992 x10-3mm2 /s ± 218, P = 0.002). Conclusion: The results of our prospective single center study show incremental value of abdominal 3T DW-MRI in comparison with CECT, especially in detecting diaphragmatic and peritoneal ovarian cancer metastases, excluding lymph nodal metastases and in differentiating malignant adnexal tumors from benign.","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"107 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116232228","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":"Faisability pilot study to explore inflammation with 18F-DPA-714 PET CT versus immunochemistry in triple negative breast cancer: Design protocol","authors":"T. Godefroy, N. Arlicot, O. Kerdraon, L. Ferrer, Nadia Fleury, F. Kraeber-Bodéré, L. Campion, C. Rousseau","doi":"10.33425/2768-4598.1009","DOIUrl":"https://doi.org/10.33425/2768-4598.1009","url":null,"abstract":"The Triple Negative Breast Cancer (TNBC), despite a good initial response to conventional chemotherapy, relapses frequently and has a poor prognosis after the onset of metastases. It is therefore interesting to develop new relevant targets to establish a prognosis but also potentially to propose a targeted therapy for a theranostic approach. A high density of M2-type macrophages presence in the primary TNBC tumor predicted an unfavorable prognosis. The presence of activated M2-type macrophages can be evaluated by measuring the expression of a translocating protein (TSPO) with [18F]-DPA-714 PETCT. This proof-of-concept study with [18F]-DPA-714 PET-CT has a design to establish the correlation between immunohistochemistry tumor characterization and in vivo imaging. If a valid correlation will be established, [18F]-DPA-714 PET-CT could be a based image prognosis biomarker, apart from pathological data, which can be fragmented as biopsy or modified by previous treatments. It would allow adapting early the type/dose-intensity of treatment and considering developments of treatments targeting M2-type macrophages","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"66 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124530132","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":"Giant cystic hygroma of the neck in a 3-year-old child: Clinical case and literature review","authors":"Caiazzo Paolo, Del Prete Immacolata, Di Lascio Pierpaolo, Guarini Giuseppe, LopesRaquel Marianna, Gilio Francesco, Iside Giovanni, Dinatale Giuseppe, Pascale Giovanni, Mirauda Maria Pia, Giuliani Antonio, Manieri Sergio","doi":"10.33425/2768-4598.1007","DOIUrl":"https://doi.org/10.33425/2768-4598.1007","url":null,"abstract":"Giant cystic hygroma of the neck often represents a pathology in children with severe potential complications and considerable technical difficulties in surgical therapy, which often makes it necessary because the alternative therapies provided are not available. A case of a cystic hygroma with a maximum diameter of 10 cm, located in the neck of a 3-year-old girl, with sudden rapid growth and an underlying inclusion cyst compressing the internal jugular vein, is described. The case was resolved with radical surgical therapy, without complications, without recurrence, and with acceptable aesthetic results.","PeriodicalId":371381,"journal":{"name":"Archives of Clinical Trials","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129060581","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}