Journal of Clinical Trials and Regulations (e-ISSN: 2582-4422)

Genesis of Clinical Trial Failure: A Review

2023-12-08T10:18:15+0530

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.

A Case Report on Papillary Thyroid Carcinoma with Involvement of Right Cervical Lymph Node

2023-10-20T14:48:15+0530

Background: Papillary thyroid carcinoma (PTC) is an epithelial harm happening to the thyroid organ. The thyroid organ is found interior the front of the lower neck. The cause of this sort of cancer isn't well built up. A family history of the infection at a genetic imperfection can be a hazard, together with this radiation increase the chance free creating thyroid cancer. The survival rate for papillary thyroid cancer is amazing. More than 90% of grown-ups with PTC survive at slightest 10 to 20 long time after treatment. Most individuals with thyroid cancer have no known risk factors, so it’s not conceivable to anticipate most cases of papillary thyroid cancer.

Radiation presentation, particularly in childhood, could be a known PTC chance figure. Because of this, healthcare suppliers do not utilize radiation to treat less genuine illnesses. Imaging tests, such as X-rays and CT filters, moreover uncover children to radiation, but at much lower doses. It’s not clear how much they might increment the hazard of PTC.

Case presentation: The case portrays a 47-year man conceded with complaints of swelling within the front of the neck with a deceptive onset. Persistent too had a gentle raspiness of voice. FNAC from the thyroid module recommended papillary thyroid carcinoma and CECT neck appeared PTC with right cervical lymph hub association. Persistent experienced quick thyroidectomy, central compartment neck dismemberment and specific neck dismemberment and treated with restorative and steady treatment.

Conclusion: Accepting a cancer determination is unsettling, notwithstanding the sort. The great news is that papillary thyroid cancer (PTC) frequently has a fabulous forecast.

Case reports are put forward the part of a multidisciplinary group within the conclusion and administration of PTC.

In Silico Exploration of Dietary Polyphenol, Bisdemethoxycurcumin as a Potential CXCL12 Inhibitor in Breast Cancer Treatment

2023-07-31T10:53:25+0530

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.

Artificial Intelligence: A Promising Tool to Manage Clinical Studies During Fertility

2023-12-05T13:31:13+0530

Artificial intelligence (AI) may be an additional catalytic instrument to manage several diseases and disorders. This review article aims to address the significant intervention of AI to manage fertility-associated clinical symptoms. Several challenges in pregnancy research lie in the necessity to consider the welfare and interests of fertile parents. In addition to that, there are several challenges to developing, designing and delivering the new drugs intended for pregnant women. Some of the AI tools perform specific subtasks within the clinical trial design process to enhance the overall performance of clinical trials. Thus, by adhering to the AI approach which can be gradually integrated into the clinical trial ecosystem. This review has also examined the difficulties that emerge when conducting trials that are intended for use during pregnancy and childhood and further, AI techniques can act as potential strategies for mitigating adverse drug reactions during trial sessions. However, Various ethical and regulatory guidelines are set up for effective trial management.

Medico-Legal Cases: An Overview

2023-09-13T14:44:42+0530

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.