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

{"title":"Enteral feeding deficient in vitamin K. Is there a related substantial bleeding risk?","authors":"Jochanan E. Naschitz, Natalia Zaigraykin, Elena Zlotover, Faisal Neime, N. Starikov, Ygor Yalonetski, G. Leibovitz","doi":"10.31579/2693-4779/087","DOIUrl":"https://doi.org/10.31579/2693-4779/087","url":null,"abstract":"Vitamin K is essential for clotting factors II, VII, IX and X to be released in their active form. Under vitamin K deficiency a coagulopathy may develop that is marked by prolongation of the prothrombin time (PT). Patients receiving enteral feeding which does not cover the daily vitamin K requirements might be predisposed to develop a bleeding diathesis. Yet, current guidelines do not recommend monitoring the PT in patients receiving enteral feeding. In the present cross-sectional study, we assessed the prevalence of a prolonged PT in patients receiving long-term enteral feeding with one or a combination of the enteral formulas Osmolite®, Jevity®, Easymilk®. Sixty residents in long-term geriatric care received exclusively enteral feeding for a median 27 months (average 34.7, SD 29). The median daily vitamin K supplied by enteral feeding was 63.5 mcg (average 8.3, SD 17.2), i.e. less than the 150 mcg recommended by the Food and Drug Administration. In 57 patients the PT-INR was 0.9 - 1.2 (normal); the PT-INR was prolonged to 1.4 in 3 patients. There were 6 episodes of major bleeding and 4 episodes of minor bleeding during the study period, unrelated to prolonged PT and distributed at random along the time of enteral feeding. Accordingly, long-term vitamin K-deficient enteral nutrition did not affect vitamin K-dependent coagulation. This may argue against the need to regularly monitor the PT in patients receiving long-term enteral nutrition","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76268942","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":"Epidemics in Ancient Imperial China – Myths, Facts and Lessons for Posterity","authors":"Jsm Leung","doi":"10.31579/2693-4779/086","DOIUrl":"https://doi.org/10.31579/2693-4779/086","url":null,"abstract":"The recorded history of China spanned over 47 centuries. Since the beginning of the first century epidemics of each dynasty had been duly, if incompletely, recorded. This study is an attempt to review the epidemics recorded from the beginning of the first century A.D., when epidemic records first appeared as a regular entry, to the beginning of the 20th century which marked the end of the last dynasty in Imperial China. No attempt is made to stratify the types of individual infections as such scientific knowledge was lacking. Rather, epidemics are treated as one subject, in the broadest sense, of massive and highly contagious infections, occurring wave after wave, affecting society, culture, governments and the rise and fall of empires dynasties. Some of the materials had been used in a previous article in this Journal but reused out of necessity. Yet, every attempt has been made to minimize excessive repetition.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89392610","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":"Describing the Cardiopulmonary Resuscitation Factors and Outcomes","authors":"S. Kazkaz, Zubaria Altaf, Pocholo Isidro, Almunzer Zakaria","doi":"10.31579/2693-4779/085","DOIUrl":"https://doi.org/10.31579/2693-4779/085","url":null,"abstract":"This study is a retrospective, descriptive review of all cardiopulmonary resuscitation (CPR) attempts at Al Wakra Hospital (AWH) conducted for one year i.e. 1st Jan 2020 to 31st Dec 2020. AWH is a 329-bedded, multispecialty secondary care facility, part of Hamad Medical Corporation (HMC), Qatar’s Governmental Healthcare organization in Qatar. In 2020, AWH had 11,862 inpatient admissions which are inclusive of Adult, Pediatric, Neonatal, Geriatric populations. There were also 1,184 admissions to the different Intensive Care Units (Medical, Surgical, Pediatric, and Neonatal). AWH has a Rapid Response Team (RRT) and Code Blue (CPR) team which is responsible for the respective codes. Code Blue team comprises one ICU Physician, one Respiratory Therapist, one Registered Nurse, all trained in Advanced Life Support. All CPR attempts were documented and recorded in CPR Record Sheets which were reviewed and the Electronic Medical Records (Cerner) were sourced for data gathering. One copy of CPR record sheets was kept in Cerner (Patient File) and one was sent to the Quality department for review/audit. After obtaining the list of CPR attempts over 2020, patients were identified, and medical records reviewed. The parameters recorded were demographic information, location, comorbidities and other relevant history, duration of CPR, initial CPR outcome, patient disposition, patient status on disposition (quality of life), etc. All these variables were considered to support the objective of this study i.e. to perform a descriptive analysis of in-hospital CPR. Based on the analysis of 110 patients for whom CPR was done, the percentage of immediate survival on the initial CPR was 53.64%. However, only 8.18% were eventually discharged to home while 11.82% were discharged to other HMC facilities.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"86 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83926595","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":"New Product Launches, Approvals, And Acquisitions to Expand Pain Management Devices Portfolio Worldwide","authors":"Ashish M. Gujrathi","doi":"10.31579/2693-4779/084","DOIUrl":"https://doi.org/10.31579/2693-4779/084","url":null,"abstract":"Advancements in technology and the approach of innovation by healthcare companies led to considerable improvements in pain management devices over the past years. From management of chronic pain to reliving post-operative pain, innovative devices have been making their way into the world. Leading device manufacturers have been developing and launching their new products that would relive and manage different kinds of pain. From knee braces to cap-sized neuromodulation devices, new products have been launched to help people improve the quality of their lives. Some of the products are in the development stage, while some have been commercialized and launched. The trend of innovation is expected to bring breakthrough devices in the coming years.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"56 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79204870","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":"Acute Hepatitis E With Elevated Alpha Fetoprotein: A Case Report and Literature Review","authors":"Wei Liu, Yuan Lu, Shijue Zheng","doi":"10.31579/2693-4779/088","DOIUrl":"https://doi.org/10.31579/2693-4779/088","url":null,"abstract":"Acute Hepatitis E (AHE) is an acute self-limiting disease caused by Hepatitis E virus infection, which is mostly transmitted through the digestive tract. A few patients can lead to severe hepatitis and liver failure. Alpha fetoprotein is a sensitive serological marker of primary liver cancer. AFP may increase in different degrees in patients with gastrointestinal tumors, endodermal sinus tumors and germ cell carcinoma originating from endoderm. In addition, serum AFP can also be elevated in varying degrees in non-neoplastic acute and chronic liver diseases. We here report a case of Acute Hepatitis E with elevated serum AFP, and discuss the clinical characteristics and significance of elevated AFP in Acute Hepatitis E through literature review.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"48 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88496346","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":"Inclusion of Immunotherapy in the Management of Primary and Metastatic Malignant Tumours of the Kidney Including Adult Renal Cell Carcinoma: A Review and Update","authors":"A. Kodzo-Grey Venyo","doi":"10.31579/2693-4779/071","DOIUrl":"https://doi.org/10.31579/2693-4779/071","url":null,"abstract":"Various tumours of primary malignant tumours of the kidney exist bot the most common type of primary malignant tumour of the kidney is renal cell carcinoma (clear cell carcinoma of the kidney tend to be encountered most often globally. The biological behaviour of a kidney tumour tends to depend upon the size of the tumour, the histological grade and stage of the tumour. Most kidney tumours that are very small (less than 7 cm) and localized to the kidney of low-grade histopathology pattern tend not to be aggressive or develop further so these days a number of patients who have small low-grade / low stage renal tumours tend to be offered expectant management of regular periodical radiology imaging and if there is any subsequent evidence of increase in the size of small localized kidney tumours, then patients who have these tumours tend to be offered treatment of curative intent. Larger localised kidney tumours that are clear cell / renal cell carcinoma tend to be treated by surgical complete excision of the tumour with the undertaking of partial nephrectomy or radical complete nephrectomy, Individuals who have locally advanced tumours tend to be treated by means of radical nephrectomy plus excision of the lymph nodes within the para-renal and para-aortic region plus adjuvant radiotherapy plus / chemotherapy. Some of the treatment options that have been used form the management of metastatic renal cell carcinoma do include surgery, immunotherapy, targeted treatment, radiotherapy, and chemotherapy. Some of the systemic font-line treatment options which are available include: immune check point inhibitor based combination (IBC) treatment with the inclusion of pembrozulimab / axitinib, nivolumab / pilimumab, as well as avelimab / axitinib. It has been iterated that with unusual exceptions, the utilization of monotherapy with vascular growth factor tyrosine kinase inhibitors or mTOR inhibitors have been considered not to be appropriate options of treatment with regard to the front-line setting. Some of the immunotherapy strategies that are utilized do include: cancer vaccines, oncolytic viruses, adoptive transfer of ex vivo activated T as well as natural killer cells and administration of antibodies or recombinant proteins which either co-stimulate cells or bloc the so-called immune checkpoint pathways. The success of many immunotherapy treatment options recently, including monoclonal antibody blocking of cytotoxic T lymphocyte-associated protein 4 (CTLA-4) as well as programmed cell death protein 1 (PD1), had boosted the development of immunotherapy and this has been ensued by description of new therapeutic targets and schemes that combine various immunology agents at a fast pace. Despite the confirmed efficacy of frontline IBC in the treatment of renal cell carcinomas, majority of the patients would eventually require the need to undergo additional options of treatment and based upon this oncologists have been advised to take into consideration this k","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"115 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77598058","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":"Neurological complications related to COVID-19 infections following exposure to airborne aerosol particles","authors":"M. Ehsanifar, M. Rafati, Jie Wang","doi":"10.31579/2693-4779/081","DOIUrl":"https://doi.org/10.31579/2693-4779/081","url":null,"abstract":"Some of the recent researches show that air pollutants such as particulate matter (PM), including fine particles (PM<2.5μm, PM2.5) and very fine particles (PM <0.1μm, PM 0.1) can reach the brain and affect CNS health. Neurological complications with Coronavirus Disease 2019 (COVID-19) have been observed. The aim of this review the relationship between air pollutants exposure and COVID-19 was focused on the role of airborne aerosol particles in the prevalence of the disease, as well as the neurological effects of COVID-19. It is not yet clear how the virus is transmitted from one sick person to another and why it is so transmissible. Viruses can be probably transmitted through speech and exhalation aerosols. Findings show that SARS-CoV-2 aerosol transmission is possible. Spike (S) proteins of SARS‑CoV‑2 determine tissue tropism using an angiotensin-converting enzyme receptor type2 (ACE-2) to bind to the cells. ACE-2 receptor is found in the tissues of the nervous system. Neurological disorders that occur with COVID-19 can have many pathophysiological backgrounds. Some are the result of a direct viral attack on tissues of the nervous system, others appear to be an autoimmune process post-viral, and still others appear to be the result of systemic and metabolic complications associated with critical illness.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84120256","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":"Major Problems Confronting the Covid-19 Pandemic","authors":"Jsm Leung","doi":"10.31579/2693-4779/075","DOIUrl":"https://doi.org/10.31579/2693-4779/075","url":null,"abstract":"Beginning from December 2019, the present COVID-19 has ravaged the world for almost two years. While it appears to have peaked in many countries, it is still not under control in other areas. Worse still, new mutations of the virus continue to drive new waves of infection which manage to break through natural and human measures of defence.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79143260","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":"Gorlin Goltz Syndrome: A Disease in Disguise","authors":"N. Jain, Ajay K. Pillai, Nisha Mishra, MD Ishtiyak, G. Reddy, S. Nahar","doi":"10.31579/2693-4779/080","DOIUrl":"https://doi.org/10.31579/2693-4779/080","url":null,"abstract":"Gorlin Goltz syndrome also known as nevoid basal cell carcinoma is an autosomal dominant inherited disorder caused due to mutation in patched (PTCH) tumor suppressor gene present in the 9q chromosome. Gorlin goltz syndrome display diversified odontogenic as well as systemic manifestations. Early diagnosis and prompt treatment is mandatory to decrease morbidity and mortality. Here we present a subtle case report of a 17-year-old boy who presented with multiple odontogenic keratocysts of the mandible and maxilla which upon further examination was diagnosed as Gorlin Goltz Syndrome.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81633652","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":"Pregnancy Following D & C and Hydrotubation After Failed IUI - A Rare Case Report.","authors":"Kalyani singh","doi":"10.31579/2693-4779/082","DOIUrl":"https://doi.org/10.31579/2693-4779/082","url":null,"abstract":"Infertility is a defined as failure to achieve a pregnancy after 12 months or more of regular, unprotected sex. It affects millions of people of reproductive age worldwide and has an impact on their families and communities. Having babies gives an unparalleled satisfaction to parents and lack of baby may make one’s life miserable at times. Here we are presenting a case where a lady who got pregnant and gave birth to a child just following Dilatation & Curettage and Hydrotuabtion (tubal flushing) when other measures like diagnostic laparoscopy and IUI failed. Dilatation and curettage and tubal patency test/ hydrotubation (D & C & TPT} was an old diagnostic procedure before the advent of ultrasonography and laparoscopic technique. It is an easy, minor operative procedure to evaluate the condition of uterus and tubes. Examination under anesthesia gives information regarding parametrium also to a considerable extent.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"147 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76136149","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}