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

{"title":"The National Recovery & Resilience Plans According to Citizens’ Perspective: will the EU regain its Leadership in Health? From the Italian Case History to the XVI European Patients’ Rights Day","authors":"M. Votta, M. Cardillo","doi":"10.31579/2693-4779/074","DOIUrl":"https://doi.org/10.31579/2693-4779/074","url":null,"abstract":"Healthcare, well-being, and a healthy lifestyle are vital for all of us. In this regard, the engagement of European citizens is key to improve the health system and it is necessary to provide a leading role to the people, the communities, intermediate bodies such as Patients' Advocacy Groups (PAGs), citizens organizations involved in healthcare issues and, more generally, to all actors that promote health as a common good. European institutions struggle to translate into concrete actions the many times highlighted principle relating to the involvement of actors of the civil society and PAGs in the management of health issues. The need to close the gap between the principles affirmed and the real involvement is even more serious when discussing about the management of serious cross-border threats to health. In line with its standing point, the civic organization Cittadinanzattiva [1], being deeply involved in health issues that promote civic participation in the policy-making activities both at the national level in Italy and, through its EU branch Active Citizenship Network (ACN) [2], also at the EU level, is working – of course not alone – to promote civic participation in the drafting and implementation process of National Recovery and Resilience Plans (NRRPs), with relevant political goals already achieved. As the Conference on the Future of Europe (CoFoE) [3] is approaching, emphasizing the great contribution of civil society to the success of the EU recovery plans is urgent and essential, now more than ever.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88304605","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 Concise Review on Ethnobotany, Phytochemistry and Pharmacology of Plant Kyllinga Triceps Rottb","authors":"Abhijeet Vishnu Puri","doi":"10.31579/2693-4779/077","DOIUrl":"https://doi.org/10.31579/2693-4779/077","url":null,"abstract":"Kyllinga triceps rottb is a member of the Cyperaceae family and is one of the world's most widely distributed medicinal herbs. This review aims to look into the published report on ethnomedicinal, phytochemical and pharmacological activity, as well as the therapeutic potential of Kyllinga triceps rottb. An extensive literature is available in various recognized databases, including logical writing and scientific literature, as well as search engines such as Springerlink, ScienceDirect, SciFinder, PubMed, Scopus, Google Scholar, and BioMed Central, as well as relevant books, websites, scientific publications, and dissertations, was used to draft an up-to-date review. Phytochemical analysis of Kyllinga triceps species indicated the presence of essential phytochemicals like flavonoids, glycosides, alkaloids, phenolics, steroids, terpenoids, and tannins, the basis of its valuable therapeutic properties. The pharmacological activities exhibited by Kyllinga triceps rottb are antidiabetic, antimicrobial, antioxidant, hepatoprotective and antimicrobial, which are attributed to the presence of valuable bioactive phytoconstituents. Considering these facts, an attempt is made to give a thorough overview of ethnobotany, phytochemistry and the pharmacological activity of Kyllinga triceps rottb.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"115 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82020637","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":"Schistosomiasis of the Testis and Other Intra-Scrotal Organs: A Review and Update","authors":"A. Kodzo-Grey Venyo","doi":"10.31579/2693-4779/072","DOIUrl":"https://doi.org/10.31579/2693-4779/072","url":null,"abstract":"Schistosomiasis of the testis and other intra-scrotal contents is a very rare condition which can be encountered within Schistosomiasis endemic areas of the world. Because of global travelling and swimming in rivers within Schistosomiasis endemic areas of the world, intra-scrotal Schistosomiasis tends to be sporadically reported in all areas of the world in male children and adults. Intra-scrotal Schistosomiasis may manifest as (a) testicular mass that may be painless and thus simulate testicular tumour, other intra-scrotal Schistosomiasis may present as hydrocele, epididymal cyst or solid/firm epididymal mass, a mass on the tunica or extra-testicular parts of the scrotum, testicular/intra-scrotal discomfort / pain. The lesion could mimic epididymo-orchitis on very rare occasions. There would tend to be a history of travel to or return from a Schistosomiasis endemic region in patients who normally dwell within the non-Schistosomiasis endemic areas of the world. There may also be a history of a previous episode of haematuria in some cases. The levels of serum Beta-Human Chorionic antigen, Alpha fetoprotein and Lactate Dehydrogenase usually tends to be normal. Some cases of Schistosomiasis of the testis had been mis-diagnosed as testicular cancer and the diagnosis of Schistosomiasis had been established based upon the histopathology examination findings of Schistosoma within the orchidectomy testis, but if there is a high-index of suspicion for Schistosomiasis of the scrotal content based upon a patient dwelling within or having travelled to a Schistosomiasis endemic area supported by a history of haematuria and the tumour or tumoral mass is completely excised for frozen section pathology examination, then the diagnosis of Schistosomiasis of the testis would be confirmed and the rest of the testis can be saved from excision. If all cases of excised epididymal cysts and Tunica from hydrocele operations are submitted for histopathology examination, then incidental cases of Schistosomiasis of scrotal contents would be made. Complete treatment of Schistosomiasis of testis and or scrotal contents does include excision / biopsy of the lesion for pathology examination confirmation and utilization of anti-Schistosomiasis medicaments. Schistosomiasis of intra-scrotal/testicular contents may be responsible for infertility and azoospermia and if this is properly investigated, diagnosed and treated this could be ensued by resolution of infertility with resulting pregnancy of the spouse and the production of a baby and because of this, individuals who have azoospermia and infertility in Schistosomiasis endemic areas, a high index of suspicion would be required in other to establish the cause as well as treat the cause of the infertility. Treatment of intra-scrotal content Schistosomiasis does entail excision / biopsy of the lesion plus utilization of anti-Schistosoma medicament and Praziquantel is a common medication that tends to be given and this tends to yie","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76842323","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":"Characterization of the Educational Methods as Prevention in Cuban’s Families’ Consumers of Alcohol","authors":"Jesús Cuéllar Álvarez, Sady Hisleydi Fariña Gutiérrez, Isabel Muñiz Casas, María Dolores Rodríguez Calvo","doi":"10.31579/2693-4779/078","DOIUrl":"https://doi.org/10.31579/2693-4779/078","url":null,"abstract":"Background: To improve the life styles from the Cuban community context of family health is a reality linked with the medical sciences. Objective: To characterize the educational methods as prevention in Cuban’s families’ consumers of alcohol. This process embraced the period of September 2018 to June 2019. The qualitative methodology was used, with a descriptive and traverse study. The universe the 45 families of studies, selected in an intentional way. Methods: Observation, interview and revision of clinic history. Results: The most frequent causing lifestyles of family dysfunction were the daily ingestion of alcoholic drinks. Conclusions: The Cuban’s families present difficulty in the family relations. The addiction to the alcohol is related with the tolerance and consumed by day that it generates in the life style from the family.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"43 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80729229","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":"Invent a Removable Orthosis with the Ability to Prevent Foot Drop and Venous Thrombosis and Maintain Muscle Contraction","authors":"A. Karbord, M. Mahmoudi, Kourosh Alimohammadbeik, Parnia Toudehfallah, Fatemeh Karimi Rouzbahani, Mahyar Mahmoudi","doi":"10.31579/2693-4779/079","DOIUrl":"https://doi.org/10.31579/2693-4779/079","url":null,"abstract":"Background Intensive care includes the care of patients with life-threatening diseases, under the supervision of the most skilled personnel with advanced equipment and facilities, which includes all sensitive care related to the patient's life. Complications of hospitalization in special wards include foot drop, deep vein thrombosis and atrophy, and decreased muscle strength. The aim of this study is working on approaches for preventing Foot drop, deep vein thrombosis and atrophy and decreased muscle strength. Methods This project started with a new researcher idea then by searching in the scientific content of articles and book, the title and proposal the project was compiled with opinion of the supervisor. Then model of the device was designed in collaboration with graphic & mechanical engineers Fianccy. The main tool was invented by the researchers. Results Results of this study and other surveys can be one of the most effective ways to prevent prevent ankle foot drop, deformity of the toes, muscle atrophy, improve blood flow from the lower to the upper and monitor vital signs and maintain the strength of the foot muscles. Also using orothesis can decrease it significantly. Besides, modifying the preventive policies such as producing instruments like Removable orthosis is recommended.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"321 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82706682","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 Girl from Qatar with Post-Infantile Acquired Cerebral Palsy Caused By Submersion Injury: A Rare Etiology and a Therapeutic Challenge","authors":"Aamir Jalal Al-Mosawi","doi":"10.31579/2693-4779/073","DOIUrl":"https://doi.org/10.31579/2693-4779/073","url":null,"abstract":"Background: Cerebral palsy is a heterogeneous disorder that can cause a lifelong disability that is associated with a non-progressive damage in the brain. It is commonly caused by antenatal, perinatal, early postnatal and neonatal conditions. However, post-neonatal cases of acquired cerebral palsy have also been reported, and were commonly caused by infection. Patients and methods: The family of a girl from Qatar, who developed severe cerebral palsy caused by submersion injury, consulted us about the possible therapies for her condition. Clinical picture and brain imaging abnormalities are described, and the relevant literatures were reviewed with the aim of suggesting possible evidence-based therapies. Results: At the age of 23 months, a previously healthy girl developed anoxic encephalopathy after experiencing submersion injury. MRI showed evidence of significant hypoxic ischemic injury primarily affecting the deep grey matter, hippocami, mid-brain and the posterior cortex. EEG showed diffuse slowness of cerebral activity and diffuse attenuation of the background without no epileptic abnormalities suggesting diffuse encephalopathy resulting from diffuse cortical injury. At the about age of three and half years, her family consulted us about her condition as she was still showing no awareness to the environment, showing no significant spontaneous movements. She had poor head control. Unable to sit or stand alone, and had a flexed posture. She was on levetiracetam (Keppra), diazepam, and baclofen 30 mg daily. She was still having tracheotomy, and was fed through gastrostomy tube. Conclusion: In this paper, the rare occurrence of severe post-infantile cerebral palsy is described. Emphasis is made on the possibility of using evidence-based multi-factorial therapies in cerebral palsy.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88863190","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":"Reducing Waiting Time in the General Pediatric Clinic at Al Wakra Hospital, Qatar","authors":"S. Kazkaz, Ghadeer Mustafa, Almunzer Zakaria, Muna Atrash, A. Tardi, Ayman Ghanem","doi":"10.31579/2693-4779/068","DOIUrl":"https://doi.org/10.31579/2693-4779/068","url":null,"abstract":"Background: Waiting times for clinic appointments constitute a key indicator of an outpatient department performance for access to care and patient satisfaction. This is particularly relevant for pediatric population. The Ministry of Public Health in Qatar set a waiting time of 28 days for patients to get new appointment in General Outpatient Department (GOPD). The current average waiting time to get a new appointment in the general pediatric clinic (GPC) at AWH is 57 days. Aim: Decrease the average waiting time to get a new clinic appointment from 57 days to 28 days by the end of December 2018, and to meet the national targets set by the Ministry of Public Health. Methodology: This is a Quality Improvement (QI) project using the Model for Improvement (MFI). The MFI framework is designed to support organizations answering fundamental questions before agreeing on drivers for change. The implementation of change was be facilitated by the Plan-Do-Study-Act (PDSA) cycles methodology. The QI project team performed a root cause analysis using the Ishikawa diagram and identified the key contributing factors to the long waiting times to get a new appointment. Twenty-seven PDSA cycle ramps were designed with support of predictive tool to test innovative changes in current operational processes in an attempt to improve waiting time in the general pediatric clinic at Al Wakra Hospital. Results: The monthly average number of referrals for GPC increased by 200% between the pre and post implementation periods. The average triage waiting time improved from 6 to 2.6 days in 2018 and the average become 1 day in 2019. Post-implementation the average waiting time for patients to get new appointment improved from 57 days to 28 days in 2018 and the average waiting time improved to 16 days in 2019. Conclusion: The quality improvement project for the AWH general pediatric clinic demonstrates significant improvement in waiting times for new appointments, the recommendation for the hospital leadership would be to rollout the improvement methodology to other clinics that suffer from similar challenges.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"44 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83571175","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 HBV Related ALF- Successful Outcome with Oral Antiviral Treatment","authors":"P. Malhotra, V. Malhotra, Y. Sanwariya, A. Chugh, I. Pahuja, A. Akshay","doi":"10.31579/2693-4779/069","DOIUrl":"https://doi.org/10.31579/2693-4779/069","url":null,"abstract":"Case report: We present a young female of fourteen years who was admitted to the hospital with short duration of Icterus, malaise, vomiting and diagnosed to be having acute hepatitis B. She went into acute liver failure as evidenced by development of hepatic encephalopathy and coagulopathy. She was managed on lines of hepatic encephalopathy along with oral antiviral treatment. She recovered successfully and was discharged after two weeks in heamodynamically stable condition. After a gap of six months, she became Hepatitis B surface (HbsAg) & hepatitis B e-antigen (HbeAg) negative and Hepatitis B Virus DNA (HBV DNA) was undetectable with normal liver function tests. She is on regular follow up for last one year and is absolutely normal. Conclusion: Acute hepatitis B can go into acute liver failure in 1% of cases, treatment for which includes liver transplantation and oral antiviral treatment which is especially helpful in cases who cannot afford liver transplantation, as was in our case.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87606208","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":"Case report of a de novo mutation of PCDH19 in Saudi family limited to females","authors":"Rawan Alsheikh, Amal Al-Qassmi","doi":"10.31579/2693-4779/063","DOIUrl":"https://doi.org/10.31579/2693-4779/063","url":null,"abstract":"Up to date more than 60 different mutations in PCDH19 have been identified. Most of PCDH19 gene is located in Xq22 and produces nonclustered delta protocadherin. This disorder primarily manifests in heterozygote females due to random X chromosome inactivation leading to somatic mosaicism and abnormal cellular interference between cells with and without delta-protocadherin., but we a heterozygous nucleotide mutation causing amino acid 561 to change from Pro to Ser (p.Pro561Ser). This mutation was de novo, and this alteration was not found in her parents. PCDH19-related epilepsy is a distinct childhood-onset epilepsy syndrome characterized by brief clusters of febrile and afebrile seizures with onset primarily before the age of three years, cognitive impairment, autistic traits, and behavioral abnormalities. We describe the features of a de novo mutation in 3 sibling, presented with early onset of seizure, two of them were controlled and wean off medication was at age of six year and her sister at age of 10 year .The youngest sister still partially controlled on medication, she had seizure only during febrile illness.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84084778","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":"Vitamin K deficiency under enteral feeding: real or imagined threat","authors":"Jochanan E. Naschitz, Natalia Zaigraykin, Elena Zlotover, Faisal Neime","doi":"10.31579/2693-4779/065","DOIUrl":"https://doi.org/10.31579/2693-4779/065","url":null,"abstract":"Patients receiving enteral feeding may develop vitamin K deficiency if the nutrition formula does not meet their daily vitamin K requirement. Vitamin K is essential for clotting factors II, VII, IX and X to be released in their functional form. Under vitamin K deficiency a coagulopathy may develop which is marked by prolongation of the prothrombin time (PT). There might be a need, unrecognized to-day, for monitoring the PT in patients receiving enteral feeding to unmask a latent coagulopathy. We assessed the prevalence of a prolonged PT in patients receiving enteral feeding for 3 months of more with one or a combination of the enteral formulas Osmolite®, Jevity®, Easymilk®. Twenty-three residents in long-term hospital care received solely enteral feeding for an average of 37 months, SD 21 months. The median daily vitamin K supplied by enteral feeding was 96.8 mcg (average 103.3 mcg, SD 28.8); this does not satisfy the 150 mcg of vitamin K required by the Food and Drug Administration. In 21 patients the PT-INR was 1-1.2 (normal). The PT was prolonged in two patients. In one of the latter, prolongation of PT-INR was not confirmed two days later. In the second case, the patient having repeatedly a PT-INR 1.4 (and a normal APTT), administration of vitamin K did not correct the PT. In conclusion, long-term vitamin K-deficient nutrition did not affect the vitamin K-dependent coagulation. This data may argue against the supposed need to monitor the PT in patients receiving long-term enteral nutrition.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87672345","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}