Applied Clinical Research, Clinical Trials and Regulatory Affairs最新文献

{"title":"Influence of nicotine upon human brain metabolism, an in vivo noninvasive Near Infrared Spectroscopy (NIRS) study","authors":"F. Crespi","doi":"10.31579/2693-4779/067","DOIUrl":"https://doi.org/10.31579/2693-4779/067","url":null,"abstract":"Nicotine, a natural alkaloid derived from tobacco, is involved in various outcomes ranging from addiction to toxicity and/or neuro-protective actions. Nevertheless, the literature on the effects of nicotine administration upon the activity of brain regions is mixed; either increased, decreased, or no overall effect was reported when being evaluated by various methodologies such as positron emission tomography (PET), functional Magnetic Resonance Imaging (fMRI). In this work, Near Infrared Spectroscopy (NIRS) is applied as it allows monitoring oxygen saturation in the living tissue as well as changes in oxygenation of hemoglobin and when applied on brain studies, it gives indications of cerebral haemo-dynamics as well as brain metabolism. In particular, here NIRS has been applied in human volunteers as this methodology is based upon the use of harmless radiations so that to provide a non-invasive, non-ionizing procedure to monitor 2 main forms of hae­moglobin: oxy-haemoglobin (HbO2) and deoxy-haemoglobin (Hb). The data gathered indicate an overall positive influence of nicotine upon HbO2 levels, as well as total blood volume (V) therefore suggesting an increased brain metabolism. Finally these data further propose NIRS with its characteristics of noninvasiveness, easy to-use, portable, restraint-free therefore relatively psychologically undemanding, as replicable and ideal methodology for clinical applications and translational approaches.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87647572","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":"Caudal Regression Syndrome","authors":"F. Bouchenaki, K. Badache, N. Habchi, M. Benachour, S. Bakhti","doi":"10.31579/2693-4779/066","DOIUrl":"https://doi.org/10.31579/2693-4779/066","url":null,"abstract":"Caudal Regression Syndrome (CRS) is a rare malformation syndrome associating to varying degrees agenesis of the coccygeal or lumbosacral vertebrae.This vertebral anomaly can therefore be reduced clinically to a simple coccygeal agenesis without any deficit or even lumbosacral agenesis accompanying a clinical picture with sphincter disorders associated or not with transit disorders and various deficits involving the lower limbs.This syndrome is accompanied by other orthopedic malformations such as shortening of the lower limbs, and / or gastrointestinal abnormalities, see also genitourinary as well as cardiovascular.Its incidence is 1 to 5 cases per 100,000 births. Its precise cause has not yet been identified, but its relationship to maternal diabetes is well established. We report in our study 5 patients with CRS from different clinics whose sphincter disorders were found in the foreground in all our patients and whose results vary according to the inaugural clinical picture. MRI made it possible to refine and confirm the diagnosis highlighting the congenital anomaly and the associated lesions.We have obtained 75% good results and 25% clinical stabilization; nor do we deplore any case of aggravation or death. The interest is to suspect the diagnosis of CRS; document it at the start of the prenatal period and determine its severity and associated abnormalities in order to present options for patient management; because once the diagnosis is made, surgical treatment becomes imperative due to the formidable neurological sequelae compromising the functional prognosis.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"56 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80207937","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":"Digital Therapeutics Hold a Promising Prospect in the Healthcare Sector – Explore How","authors":"Ashish M. Gujrathi","doi":"10.31579/2693-4779/060","DOIUrl":"https://doi.org/10.31579/2693-4779/060","url":null,"abstract":"The treatments of several diseases are evolving continuously towards a digital future indeed. Digital therapeutics use digital technologies to prevent, manage, or cure physical and mental health conditions. In the past ten years, the outcomes from digital therapeutics in a broad range of symptoms, such as cancer, ADHD, asthma, mental disorders, and insomnia have improved to a great extent, thereby making it more popular around the world.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"71 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85645662","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":"Phytochemical & Pharmacological Studies of Moltkiopsis ciliata","authors":"M. Kamil, F. A. M. T. Abdalla","doi":"10.31579/2693-4779/062","DOIUrl":"https://doi.org/10.31579/2693-4779/062","url":null,"abstract":"The stem and branches have silvery white colour with a pink tint. They bear stiff covering trichomes and leaves or leaves remaining are found at their numerous inter nodes. Dark brown scars are left by falling leaves. The branches are brittle and their outer layer separate on breaking. Microscopically، the powder shown many free conical، warty، tapering covering trichomes of various lengths and sizes; the comparatively smaller ones belong to leaves while the significantly large ones are detached from stem and branches. The powder also shows light orange-brown fragments of leaf exhibiting compact endings of palisade cells rounded in outlines; some of these fragments bear many covering trichomes. There are also many grey or grayish-brown fragments of fibro-vascular tissues of branches، some are thick and closely packed، in addition to many fragments of light brown bark cells polygonal or almost square in outlines.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"69 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75627282","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":"The Effects of Neurosculpting® Meditation on Stress, Anxiety and Sleep on one group of college students","authors":"Kathleen K Kelley","doi":"10.31579/2693-4779/061","DOIUrl":"https://doi.org/10.31579/2693-4779/061","url":null,"abstract":"Objective: The purpose of this study was to examine if 11 weeks of Neurosculpting® meditation improved sleep and other variables in college aged students. Participants: Fifteen undergraduate students. Methods: Subjects were evaluated at the beginning and end of the semester using two tools: The Pittsburg Sleep Quality Index and the Depression Anxiety Stress Scale. During each session, heart rate and heart rate variability were measured using a smartphone app, fingertip sensor, and HRV monitor. Subjects received 60 minutes of Neurosculpting® Meditation, one time per week, for 11 weeks. Results: The average score of both the DASS and PSQI decreased (p = .54) and (p = .08) respectively. Within each session, average HR decreased and average HRV increased. However, neither variable showed significant changes from the beginning to the end of the semester. Conclusions: This study demonstrated that consistent Neurosculpting® meditation sessions may improve heart rate variability and sleep in college aged students.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"132 1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79619603","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":"Black Fungus an Escalating Threat for Covid-19 Patients Calling Out Captivation","authors":"Humaira Zafar, Irfan Ali Mirza, Wajid Hussain, M. Fayyaz","doi":"10.31579/2693-4779/053","DOIUrl":"https://doi.org/10.31579/2693-4779/053","url":null,"abstract":"Background Current year 2021, brought a hope for the world due to availability of various vaccines to prevent COVID 19. Researchers around the Globe, kept working around the clock to dig up various correlations of this infection. So, that morbidity and mortality rates can be reduced. In all this sprint, cases of black fungus came into light in India. The Indian researchers identified strong association of black fungus co infection in COVID patients resulting in high mortality rates. Objectives Therefore, this current systematic review was planned to identify the predisposing factors, clinical presentations and management options for black fungus in COVID 19 patients. Methodology: This ‘systematic review’ was carried out following preferred reporting items for systematic review and meta-analysis (PRISMA) guidelines & various search engines. Total 20(N) articles were selected and included for study. After following PRISMA guidelines and based upon inclusion and exclusion criteria of study, total 05 (N) manuscripts, were included. Results Out of 05(N) selected articles, 80 %( 04) strongly supported strong association of black fungus with COVID 19 patients. The highlighted predisposing factors includes, immunosuppression, anti virals, prolong hospital stay, use of tocilizumab and steroids as management of COVID patients. Timely diagnosis and provision of anti-fungal can be helpful to reduce mortality form this co infection. Conclusion It is concluded that immunosuppression, anti virals, prolong hospital stay, use of tocilizumab and steroids as management of COVID predisposes to black fungus. Timely diagnosis and use of systematic anti fungals can reduce mortality rate form this co infection.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74950998","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":"Hydatid Cyst of the Breast: A Review and Update of the Literature","authors":"A. Kodzo-Grey Venyo","doi":"10.31579/2693-4779/055","DOIUrl":"https://doi.org/10.31579/2693-4779/055","url":null,"abstract":"Hydatid cyst of the breast is a rare infection of the breast that tends to be reported sporadically in Echinococcus infection endemic areas; nevertheless, because of increasing global travel hydatid cyst of the breast may be encountered in a non-endemic area of the world where clinicians may not be familiar with the manifestation and biological behaviour of the disease. Hydatid cyst of the breast has been reported sporadically in females whose ages have ranged between 16 years and 87 years and these cases only represent 0.27% of all cases of hydatid cyst encountered globally. Hydatid cyst of the breast does present as a lump/mass in the breast which quite often tends to be painless but it could be associated with pain/discomfort. Hydatid cyst of the breast tends to present insidiously and the lump tends to be present for a long time before attention is sought by the patient because it had behaved innocuously and had either been growing slowly with a recent noticeable increase in size over a few months. A history of previous contact with dogs and sheep as well as present or previous residence in an echinococcus endemic area tends to be helpful in alerting the clinician to the possibility of the diagnosis of hydatid cyst. A past history of treatment for echinococcal infection elsewhere in the body would also be helpful in alerting the clinician to the diagnosis of the disease. There tends to be no family history of breast cancer, and no history of previous hormone replacement therapy. The general and systematic examinations of most of the patients tend to be normal unless they have other non-related medical conditions. Clinical examination usually tends to reveal a swelling that tends to be well-circumscribed with clear margin that may be non-tender but at times there may be tenderness associated with the lump. The clinical examination findings tend to be non-specific and would usually mimic fibroadenoma, phyllodes tumour, or intra-cystic carcinoma of the breast. Usually the results of routine haematology and haematology blood tests would tend to be normal unless there is a non-related disease but there could be eosinophilia. Echinococcus hemagglutination test and Elisa test for Echinococcal IgE test would tend to be positive in cases of hydatid cyst of the breast. Various radiology imaging modalities tend to be utilized to assess hydatid cyst of the breast including mammogram, ultrasound scan of the breast, computed tomography (CT) scan of the breast, thorax, and abdomen, magnetic resonance imaging (MRI) scan of breast, thorax, and abdomen. Diagnosis of hydatid cyst of the breast tends to be diagnosed by undertaking fine needle aspiration biopsy of the breast lesion for cytology/histopathology examination or histopathology examination of excised hydatid cysts of the breast. Successful treatment of hydatid cyst of the breast requires complete excision without spillage of the hydatid cyst and additionally to minimise recurrence of disease Albendazol","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79168121","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":"The Role of Positron Emission Tomography - Computed Tomography (PET - CT) Scan in the Assessment and Management of Carcinoma of the Prostate Gland: A Review and Update","authors":"A. Kodzo-Grey Venyo","doi":"10.31579/2693-4779/054","DOIUrl":"https://doi.org/10.31579/2693-4779/054","url":null,"abstract":"Background: PET CT Scan has been used on numerous occasions in the assessment and management of various malignancies but it is only occasionally used in the assessment management of carcinoma of the prostate gland globally. There is the need to establish whether or not PET/CT scan is a useful imaging technique which should be used more often in the investigation of biochemical failure following treatment of carcinoma of prostate gland with curative intent Aim: To investigate the suggestion that PET/CT scan would be a useful and reliable imaging option for the investigation of biochemical recurrence resulting following the treatment of prostate cancer with curative intent by reviewing the literature relating to the use of PET / CT scan in carcinoma of the prostate gland. Method: Various internet data bases were searched including: Google, Google Scholar, Yahoo, and PUBMED. The search words that were used included: PET/CT Scan in carcinoma of the prostate, PET/CT scan in prostate cancer, PET/CT scan and prostate cancer, PET/CT scan and carcinoma of the prostate. Results: Fifty two manuscripts that have been published relating to the use of a form of PET/CT scan in relationship to investigation of carcinoma of the prostate gland were utilized to write the article. One of the articles published in Dutch was a review article. Another paper reported the use of PET CT scan in the diagnosis of Hurtle tumour (a benign tumour) in association with carcinoma of the prostate gland. The remaining manuscripts contained case reports and studies regarding the use of various types of PET/CT scan in the investigation of biochemical failure as well as in the treatment and follow-up of some cases of metastasis. On the whole almost all of the papers had confirmed the high sensitivity and high specificity of PET/CT scan in detecting localized and distant metastatic lesions in the scenario of slight elevations of serum PSA. There have been reports of PET/CT scan being able to detect localized and distant metastasis when conventional computed tomography scan and isotope bone scan failed to detect metastases. In one case when the serum PSA level was high isotope bone scan and CT scan failed to detect bone metastases but PET/CT scan detected bone metastases. Conclusions: PET/CT Scan is a very useful imaging modality that detects localized and distant metastases in biochemical recurrence of prostate cancer and this modality of imaging should be used more often from now onwards. CT scan would usually detect nodes/lesions that measure 1 cm or larger but PET/CT scan would detect smaller sized lesions at slightly raised levels of serum PSA. The detection of small localized metastasis at a slightly elevated serum PSA values would make it easier for the undertaking of a second-line treatment of curative intent in the form of salvage lymphadenectomy or salvage radiotherapy targeted at the lesion. Perhaps PET/CT scan should be the first-line imaging modality which should be used in","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83310724","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":"Assessment of Clinical Characteristics and Chest CT Findings of COVID-19 Prediagnosed Patients Admitted to the Emergency Department: A Retrospective Study","authors":"Murat Muratoglu, Sevil Ozek, Hayrettin Meftun Kaptan, Ishaaq S akwa Eshikumo, Ishaaq Sakwa Eshikumo","doi":"10.31579/2693-4779/058","DOIUrl":"https://doi.org/10.31579/2693-4779/058","url":null,"abstract":"Introduction: This study aimed to define the clinical features and laboratory findings that may be associated with COVID-19 pneumonia in patients with suspected COVID-19 pneumonia who presented to the emergency department in order to be able to recognize the disease early until molecular tests are available, and thus to isolate sick people as soon as possible. Patients and Methods: We retrospectively examined patients who were evaluated with the suspicion of COVID-19 between March 2020 and August 2020. We used the patient information management system to record patient demographic and clinical features, laboratory findings, and CT results. In subgroups with and without pneumonia, we compared these characteristics in confirmed COVID-19 patients. Results: Our study included 1,277 patients who were evaluated for suspected COVID-19. COVID-19 pneumonia was detected in 71.2% (n=210) of a total of 295 (23.4%) patients with a diagnosis of COVID-19 who were confirmed by RT-PCR positivity. Although 56.2% (n=18) of those with pneumonia were men, no statistically significant relationship was detected between gender distribution and CT findings (p=0.449). When we compared the patients in 3 subgroups according to age groups, it was observed that 59.4% (n=38) of those with negative CT findings were in the 18-44 age group, and 44.8% (n=94) of those with positive CT findings were 65 and over age group, and this distribution was found to be statistically significant (p<0.001). Pneumonia was detected in 58.3% (n=49) of COVID-19 cases (n=84) with a suspected exposure history (p=0.008). The most common symptoms in patients with positive CT findings (n=210) were fever (40.5% n=85) and fatigue (40.5% n=85), cough (32.9% n=69), and shortness of breath (28.6% n=60). The most common comorbidity in cases diagnosed with COVID-19 was HT (33.9%; n=100/295), followed by AF (19.3%; n=57/295), and the rates of HT and AF in those with COVID-19 pneumonia were statistically significantly higher compared to the CT-negative group (p<0.001 and p=0.002, respectively).COVID-19 pneumonia was more common in hospitalized patients (n=124), and hospitalization lengths were longer in both emergency and ICU admissions (p<0.001 and p=0.008). In our analysis in terms of the survival relationship, it was observed that 87.5% (n=35) of the COVID-19 cases who died had pneumonia (p<0.042). Low saturation and high respiratory rate per minute at the time of admission were associated with COVID-19 pneumonia (p<0.001). In the group with COVID-19 pneumonia, haemoglobin, GFR, and pCO2 values were recorded lower at the time of admission compared to patients with negative CT (p<0.001, p<0.001, p<0.05, respectively), while leukocytes, neutrophils, CRP, D-dimer, LDH, hs-troponin, AST and bilirubin were recorded as higher (p<0.05, p<0.01, p<0.001, p<0.001, p<0.001, p<0.001, p=0.01, p=0.01, respectively). Conclusion: Identifying patient features linked with COVID-19 pneumonia at the time of admission may influen","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"90 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90968514","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":"Physicians’ knowledge, attitude, practice and perceived barriers to subject recruitment for randomized controlled trials in ghana.","authors":"Ubong U. Ekpene, M. Ametefe, P. Bankah, George Wepeba, H. Akoto, J. Boatey, Mutawakilu Iddrissu, T. Dakurah","doi":"10.31579/2693-4779/045","DOIUrl":"https://doi.org/10.31579/2693-4779/045","url":null,"abstract":"Objectives: This study assesses the knowledge, attitude, practice and perceived barriers to subject recruitment into randomized controlled trials, and determine strategies to maximize subject recruitment and retention. Methods: A cross sectional, quantitative survey of 73 physicians working in Ghana was conducted assessing their knowledge and attitude towards randomized controlled trials, subject recruitment practices, self-reported barriers to subject recruitment and strategies to enhance subject recruitment. Results: Responses from 73 Ghanaian physicians were analyzed. 23 (31.5%) respondents knew of ongoing clinical trials in their specialty in Ghana while 32 (43.8%) physicians knew about trials in their specialties in various places in the world. 23 (31.5%) physicians responded that they had referred patients for recruitment into clinical trials before. 49 (67.1%) respondents had never referred any patient for recruitment into clinical trials. Conclusion: Most Ghanaian doctors are unaware of ongoing trials in their specialty and thus do not refer patients for recruitment.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"108 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87627574","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}