Journal of clinical trials and regulations最新文献

{"title":"Genesis of Clinical Trial Failure: A Review","authors":"S. Chaudhry, Abhijit Trailokya","doi":"10.46610/jctr.2023.v05i02.005","DOIUrl":"https://doi.org/10.46610/jctr.2023.v05i02.005","url":null,"abstract":"Clinical Trials are often labelled as failure or negative when the anticipated results are not observed. The negative results can be due to multiple factors such as primary and secondary endpoints not being met higher incidence of adverse reactions, and sluggish recruitment of trial subjects due to stringent inclusion and exclusion criteria, higher dropout rates due to changed biochemical parameters such as raised liver or hepatic enzymes. Trial Failures are reported globally but within developing countries, the reports are meagre. Inclusion in trials imposes a financial burden on patients and hence dropout rates proportionately increase. Recruitment of patients is often better in open trials as compared to blind studies as drug awareness imposes better confidence in the recruited subjects. The oncology trials that use biomarkers in patient selection have higher overall success probabilities than trials without biomarkers. Complexities in drug development and the inherent uncertainties in medical research also play an important role in a high rate of clinical trial failures.","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":"49 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139011727","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":"Medico-Legal Cases: An Overview","authors":"Gurmeet Singh Sarla","doi":"10.46610/jctr.2023.v05i02.002","DOIUrl":"https://doi.org/10.46610/jctr.2023.v05i02.002","url":null,"abstract":"A Medico-Legal Case can be defined as a case of injury or ailment in which investigations by the law-enforcing agencies are essential to fix the responsibility regarding the causation of the injury or ailment. Once the attending doctor decides to treat the case as Medico Legal Case, immediately he is required to inform the jurisdictional police as provided under Section 39 of Criminal Procedure Code, failure to do so, may result in a prosecution under Sections 176 or 202 of Indian Penal Code. Based on the report, police visits the patient to verify details mentioned in Medico-Legal Case. If there is subsequent death of patient or if the relatives wish to take a legal action against the offender, then based on the Medico-Legal Report, a First Information Report is registered under the relevant Indian Penal Code section. Medical practitioners share the responsibility of action against crime by supporting the justice system. The best way for a medical practitioner to achieve this is by proper examination of victims and/or perpetrators, and completing the legal documents meticulously. Medico-legal documentation is more than the compilation of a medico-legal report. Inappropriate completion of medico-legal documentation may necessitate the practitioner having to explain the documentation to make it understandable to the court.","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135740764","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":"In Silico Exploration of Dietary Polyphenol, Bisdemethoxycurcumin as a Potential CXCL12 Inhibitor in Breast Cancer Treatment","authors":"A. Mishra","doi":"10.46610/jctr.2023.v05i02.001","DOIUrl":"https://doi.org/10.46610/jctr.2023.v05i02.001","url":null,"abstract":"Breast cancer stands as one of the most prevalent malignancies in women worldwide. The World Health Organization reported 2.3 million new cases and 685,000 fatalities due to breast cancer in 2020. In India alone, 162,468 new diagnoses and 87,090 deaths were recorded in 2018. CXCL12, also known as stromal cell-derived factor 1 (SDF-1), plays a significant role in tumor progression and metastasis in breast cancer, rendering it a promising target for intervention. Curcumin and its derivatives are known to inhibit breast cancer and enhance the efficacy of chemotherapeutic drugs. This study explores the potential of Bisdemethoxycurcumin, a synthesized derivative of curcumin, as a CXCL12 inhibitor in breast cancer. Our in-silico screening of Bisdemethoxycurcumin demonstrated a strong binding affinity to CXCL12, surpassing that of the reference compound, Plerixafor. We also compared our lead molecule with the reference compound (Plerixafor). Conversely, we observe that Bisdemethoxycurcumin shows a good binding affinity with the target protein and shows a strong bond interaction, particularly H-bond interaction in molecular docking and MD simulation studies both. Our findings identify Bisdemethoxycurcumin as a lead compound for future studies, necessitating validation through in vitro and in vivo investigations.","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43186859","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":"Gel of Betel (Areca Catechu Linn.) Nut Ethanol Extract Activity Test as Cuts Healing against Diabetic Rabbits (Oryctolagus cuniculus)","authors":"E. Gunawan, M. Silvia, Nur Fadilah Bakri","doi":"10.46610/jctr.2023.v05i01.004","DOIUrl":"https://doi.org/10.46610/jctr.2023.v05i01.004","url":null,"abstract":"Background: Areca nut (Areca catechu Linn.) contains the main components in the form of tannins, flavonoids, alkaloids, and saponins. People usually use the young betel nut as cuts medicine by mashing it and applying it directly to the cuts cut area or by boiling the betel nut and the boiled water is used to clean cuts and other skin infections. Objective: The purpose of this study was to determine the effect of giving betel nut (Areca catechu Linn.) ethanol extract gel and to determine the most effective concentration of cuts healing in diabetic rabbits (Oryctolagus cuniculus). Method: This study used 6 treatment groups, namely the group that was given a gel with an extract concentration of 1%, 3%, and 5%, a group that was given conventional preparations as a positive control, a group that was given a gel base as a negative control, and a group that was not given the test substance. The rabbit's back area was anesthetized with 2% lidocaine subcutaneously and a 2 cm long incision was made with a depth of 1.5 mm using a scalpel. The data obtained were the percentage of cuts healing in diabetic rabbits which were analyzed using One-way ANOVA. Results: The results showed that the percentage of cuts healing was 100% healed on gel treatment with 1% areca nut ethanol extract on the 11th day, gel with 3% betel nut ethanol extract on the 11th day, and gel with 5% betel nut ethanol extract on the 10th day. The results of One-way ANOVA statistical analysis showed a significant difference in the cuts healing effect of diabetic rabbits in each treatment with a value of p = 0.000 (p <0.05). Conclusion: The results of the study concluded that areca nut has activity in cuts healing in diabetic rabbits which was formulated in the form of a gel with an extract concentration of 5%.","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44240990","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 Review on Angiosarcoma of the Breast: Case Studies","authors":"Palvi Sharma, Vikrant Dalwal, Sunaina Rana, Shilpa Thakur, Anu Sharma","doi":"10.46610/jctr.2023.v05i01.003","DOIUrl":"https://doi.org/10.46610/jctr.2023.v05i01.003","url":null,"abstract":"An uncommon kind of cancer called angiosarcoma originates in the lining of lymph and blood arteries. The immune system includes the lymphatic vessels. The lymph vessels remove waste materials, viruses, and germs from the body. Any region of the body can develop cancer of this kind. Angiosarcoma is an aggressive tumour, It is a form of soft tissue sarcoma. The treatment of angiosarcoma is very difficult. Breast cancer arises in the breast's lymphatic or blood vessel networks eventually migrating to the breast and the skin of the arms. Most angiosarcomas have unknown origins. Researchers have found a number of variables that could raise the disease's risk. Angiosarcoma develops when the DNA of cells lining a blood artery or lymph channel changes. The instructions that inform a cell what to do are encoded in its DNA. The adjustment which scientists refer to as mutations, instruct the cells to divide quickly. When healthy cells would perish, the alterations prevent the cells from dying. As a result, cancer cells can accumulate and spread outside of the blood vessel or lymph channel. Cancerous cells are able to infiltrate and obliterate healthy body tissue. Cancer cells could eventually separate and travel to different parts of the body. Angiosarcomas have a rapid development rate and body-wide dissemination. Breast angiosarcomas come in two varieties, primary and secondary, and they are both treated surgically by removing the tumour. Angiosarcoma can be spread in other part of body from breast. Primary breast angiosarcoma is an uncommon kind of breast cancer that only affects women, typically developing in the third to fourth decade. For diagnosis, biopsy, mammogram, breast MRI, PET Scan, ultrasound were performed and for the treatment of breast cancer surgery, chemotherapy, radiotherapy were performed. Only 0.04% of malignant breast tumours are primary breast angiosarcomas, making it a rare form of breast cancer. Secondary malignant tumour growth is one of the dangers of therapeutic radiation. In this paper, various cases are reported of angiosarcoma of the breast.","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46154855","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":"Nutritional Optimization for Post-Spinal Surgery Recovery.","authors":"Anjalika Chalamgari, Grace Hey, Akanksha Dave, Annika Liu, Aparna Nanduru, Brandon Lucke-Wold","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Adequate nutritional intake is a key component of uncomplicated recovery from spinal surgery. Though much in the literature exists regarding its importance, specific dietary regimens for spinal surgery remain understudied, and little is available in compiling both preoperative and postoperative nutritional recommendations for patients. The complexity that may exist with these recommendations -- especially in the context of patients with diabetes or those who use substances -- has led in recent years to the development of protocols such as Enhanced Recovery After Surgery (ERAS), which gives providers a guideline upon which to base their nutritional counselling. More innovative regimens, such as the use of bioelectrical impedance analyses to assess nutritional status, have also emerged, resulting in a vast array of dietary recommendations and protocols for spinal surgery. In the following paper, we aim to compile a few of these guidelines, comparing various preoperative and postoperative nutritional strategies as well as making note of special considerations, like patients with diabetes or those who use substances. We also work to overview several such dietary \"protocols\" available in the literature, with a special focus on ERAS and more recent regimens like the Northwestern High-Risk Spine Protocol. We briefly mentioned preclinical work on novel nutritional recommendations as well. Ultimately, we hope to highlight the importance of nutrition in spinal surgery and address the need for greater cohesion of dietary strategies already in existence.</p>","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":"5 1","pages":"1-16"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9431259","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":"Vital Medications in the World According to Preliminary BCS Classification: Prognostication of Solubility and Permeability","authors":"Kiran Dudhat","doi":"10.46610/jctr.2022.v04i02.001","DOIUrl":"https://doi.org/10.46610/jctr.2022.v04i02.001","url":null,"abstract":"The Biopharmaceutical Classification System (BCS) has been used as a predictive method to evaluate potential formulation impacts on oral medication bioavailability in humans. The BCS can assist in the prediction of in vivo product performance and the construction of mechanistic models that enable formulation assessments through the generation of scenarios when used in conjunction with in vitro dissolution testing. The applicability of current human BCS standards has not yet been examined in dogs, which restricts its application in canine medication development. The BCS has had a significant impact on drug discovery, development, and regulation on a global scale and the BCS continues to receive much validation, discussion, and extension in the literature. Drug regulatory organizations from all across the world have fully deployed the BCS when establishing bioavailability/bio-equivalence requirements for the approval of oral drugs with instant release (IR). In this study, we examine the provisional BCS classification of the most popular medications sold worldwide and discuss the BCS scientific framework and its influence on regulatory exercise of oral medicinal products. Also mentioned is the Biopharmaceutical Drug Disposition Classification System and how it relates to the BCS.","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42597028","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":"Surgical Management of Neurotrauma: When to Intervene.","authors":"Daisy Valle, Xuban Palau Villarreal, Caroline Lunny, Anjalika Chalamgari, Manahil Wajid, Arman Mahmood, Siya Buthani, Brandon Lucke-Wold","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Neurotrauma, often defined as abrupt damage to the brain or spinal cord, is a substantial cause of mortality and morbidity that is widely recognized. As such, establishing an effective course of action is crucial to the enhancement of neurotrauma guidelines and patient outcomes in healthcare worldwide. Following the onset of neurotraumatic injuries, time is perhaps the most critical facet in diminishing mortality and morbidity rates. Thus, procuring the airway should be of utmost priority in a patient to allow for optimal ventilation, with a shift in focus resorting to surgical interventions after the patient reaches a suitable care facility. In particular, ventriculoperitoneal shunt (VPS) procedures have long been utilized to treat traumatic brain and spinal cord injuries to direct additional cerebrospinal fluid (CSF) from the lateral ventricles through a ventricular catheter attached to a valve that is further connected to a distal catheter. Decompressive cranio omie (DCs), cranioplasties, and intracranial pressure measurements (ICP) are also frequently performed in combination with VPS to manage intracranial hypertension and cerebral edema. Although the current surgical methods utilized in the treatment of neurotrauma prove to be highly efficacious in the prevention of adverse outcomes, emergent therapies are growing in popularity. Of interest, the Three Pillars Expansive Craniotomy, cisternostomy, and external lumbar drainages are cutting-edge procedures with promising results that can potentially usher change in the neurosurgical industry but require additional examination.</p>","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":"4 2","pages":"41-55"},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9211591","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":"Clinical Application of Tocilizumab in Covid-19 Patients","authors":"Pranjal Chandrakar, Hemasri Velmurugan, P. T, D. Dash, Vaibhav Tripathi","doi":"10.46610/jctr.2022.v04i01.001","DOIUrl":"https://doi.org/10.46610/jctr.2022.v04i01.001","url":null,"abstract":"Over these previous years, clinicians dealing with patients with COVID infection 2019 have discovered that the abundant inflammatory response induced by the virus serves as a significant cause of the acute respiratory distress syndrome (ARDS) and multi-organ dysfunction, which happen in majority of the lethal cases. Presently, there is not a single drug available as an approved and genuine medication for corona infection, in this sphere of time immunomodulatory agents has exhibited encouraging response against coronavirus infection. The initial finding that interleukin-6 (IL-6) levels are raised in serious COVID-19 and independently foresee the risk of developing ARDS and finally death, such results had centered the clinical investigations on this pro-incendiary and pleiotropic cytokine. Tocilizumab (TCZ) is humanized anti-interleukin 6 receptor monoclonal immunizer and has been endorsed for different rheumatological ailments. Currently, many steroids as they act as an immunomodulatory agent have shown fantastic therapeutic effects while used in COVID infected peoples, such clinical data advocated the application of tocilizumab to combat corona infection. Patients who were in life threatening condition because of COVID-19 initiated pneumonia developed hyper aggravation. This medication lessens the further decay of the patient caused because of agglomeration of lymphocytic cells and diminishes the degree of high CRP (C-responsive protein). Nevertheless, several clinical investigations have been in progress to ascertain the drug profile. So that TCZ may be used in COVID patients with optimal effectiveness associated with minimum risk of adverse events. In this article, we have tried to encompass all relevant information about the pharmacology of TCZ, which will surely help to understand clinical behaviour of the drug.","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70565668","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":"Pharmaceutical Law and Patent Law","authors":"Carlo A. Piria","doi":"10.46610/jctr.2021.v03i02.005","DOIUrl":"https://doi.org/10.46610/jctr.2021.v03i02.005","url":null,"abstract":"The patent law and pharma laws and regulations need to be coordinated. The interpretative proposal of the author is that a patent claim aiming at protecting the invention as a medicinal product must necessarily be expressed using the appropriate terms provided for by the laws and regulations concerning the industrial medicinal product, such as “medicinal product” and “active substance”; otherwise the patent may not be considered as covering a “medicinal product” or an “active substance”. Moreover, as a consequence, the presentation of a product in a patent claim as a medicinal product or an active substance implies that the enforceability of such claim is conditioned upon the demonstration of the efficacy and safety of the product through the preparation and approval by the competent authorities of a dossier of pharmacological and clinical trials. The legal system taken into consideration by the author is the European one, but the interpretative proposal is, mutatis mutandis, applicable to other systems of law.","PeriodicalId":73671,"journal":{"name":"Journal of clinical trials and regulations","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41365763","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}