Reviews on Recent Clinical Trials - Volume 19, Issue 1, 2024

Background: Cancer and infectious diseases are one of the greatest challenges of modern medicine. An unhealthy lifestyle, poor drug use, or drug misuse contribute to the rise in morbidity and mortality brought on by these illnesses. The inadequacies of the medications now being used to treat these disorders, along with the growing issue of drug resistance, have compelled researchers to look for novel compounds with therapeutic promise. The number of infections and diseases has significantly abated due to vaccine development and use over time, which is described in detail. Several novel vaccines can now be produced by manipulating Deoxyribonucleic acid (DNA), Ribonucleic acid (RNA), Messenger Ribonucleic acid (mRNA), proteins, viral vector Recombinant, and other molecules due to advances in genetic engineering and our understanding of the immune defense. Objective: The main topic of discussion is cancer-based vaccinations, which were developed less than a decade ago but have already been used to treat a wide range of both life-threatening and deadly diseases. It contains clinical studies for cancer vaccines against kidney, liver, prostate, cervix, and certain RNA-based cancer vaccines against breast and bladder cancer. Results: Numerous studies using various DNA and RNA-based methods have been conducted on the basis of cancer, with 9-10 diseases related to DNA and 8–9 diseases associated with RNA. Some of these studies have been completed, while others have been eliminated due to a lack of research; further studies are ongoing regarding the same. Conclusion: This brief discussion of vaccines and their varieties with examples also discusses vaccine clinical trials in relation to cancer diseases in this DNA and RNA-based cancer vaccine that has had successful clinical trials like the cervical cancer drug VGX-3100, the kidney cancer drug Pembrolizumab, MGN-1601, the prostate cancer drug pTVG-HP with rhGM-CSF, the melanoma cancer drug proteasome siRNA, and the lung cancer drug FRAME-001.

Background: Solid organ transplantation is a life-saving medical operation that has progressed greatly because of developments in diagnostic tools and histocompatibility tests. Crossmatching for complement-dependent cytotoxicity (CDC) and human leukocyte antigen (HLA) typing are two important methods for checking graft compatibility and reducing the risk of graft rejection. HLA typing and CDC crossmatching are critical in kidney, heart, lung, liver, pancreas, intestine, and multi-organ transplantation. Methods: A systematic literature search was conducted on the internet, using PubMed, Scopus, and Google Scholar databases, to identify peer-reviewed publications about solid organ transplants, HLA typing, and CDC crossmatching. Conclusion: Recent advances in HLA typing have allowed for high-resolution evaluation, epitope matching, and personalized therapy methods. Genomic profiling, next-generation sequencing, and artificial intelligence have improved HLA typing precision, resulting in better patient outcomes. Artificial intelligence (AI) driven virtual crossmatching and predictive algorithms have eliminated the requirement for physical crossmatching in the context of CDC crossmatching, boosting organ allocation and transplant efficiency. This review elaborates on the importance of HLA typing and CDC crossmatching in solid organ transplantation.

Dupilumab is a fully humanized IgG4 monoclonal antibody, inhibiting IL-4 and IL-13 signaling, which are the main cytokines involved in type 2 inflammatory diseases. Its introduction was a breakthrough in the treatment of moderate-to-severe atopic dermatitis, but it is also used in other inflammatory diseases, including asthma, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis. Recent advances in the understanding of inflammatory pathways have revealed that Th2-type inflammation is involved in a wider range of diseases than previously thought. The aim of our review is to examine off-label therapeutic indications of dupilumab, including bullous dermatoses (pemphigus, bullous pemphigoid) and alopecia areata, and to investigate its potential applications in cancer patients on anti-PD1 therapy.

Aim: The purpose of the present study was to determine cancer patients’ attitudes toward the anti-COVID-19 vaccine. Background: Historically, the scientific community’s responsibility was to investigate attitudes about vaccination. The course of COVID-19 in cancer patients makes them a high priority for vaccination. Cancer patients are at greater risk of serious complications and death because of COVID-19 infection. Objective: The purpose of the present study was to determine cancer patients’ attitudes toward the anti-COVID-19 vaccine. We examined several constructs that potentially influenced cancer patients' perceptions of the vaccine: health status, knowledge of COVID-19 and vaccination, cancer patients' perceptions of vulnerability, and attitudes toward general vaccines. Methods: We conducted a collective case study with 200 cancer patients undergoing treatment, and divided the sample into two groups: patients who “expected to heal” (Group A) and patients who “expected to chronicize” (Group B). Data were collected through a purpose-built questionnaire consisting of 22 questions and a study of medical records. Results: Data analysis showed that both groups, Group A (M= 3.89 SD= 0.64) and Group B (M= 3.98 SD= 0.64), had a favorable attitude toward the anti-COVID-19 vaccine. This favorable attitude toward the anti-COVID-19 vaccine depended on several factors: perception of vulnerability to COVID-19, perception of the severity of their oncological situation, and communication with oncologists. Conclusion: Our study highlighted the plurality of factors that influence attitudes toward the anti-COVID-19 vaccine. It is therefore of fundamental importance to increase the use of the shared decision-making approach (SDM) to guide the patient to an informed choice.

Background and Objective: Abdominal pain is a frequent reason for admission to the Emergency Department. It may be a symptom of an underlying "organic" disease or a "functional" manifestation without an underlying anatomic or physiologic alteration. The evaluation of patients with abdominal pain is a challenge for the emergency physician and the selection of patients for second-level radiological examinations or endoscopic procedures is not always easy to perform. Faecal calprotectin could be a useful diagnostic marker to distinguish between "organic" or "functional" form and its determination could be helpful to select patients for further examinations in the context of an emergency setting. Materials and Methods: This is an observational and retrospective study on 146 patients with abdominal pain and/or diarrhea (with or without rectal bleeding) admitted to the Emergency Department of Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, who collected a fecal sample to evaluate fecal calprotectin. We evaluated and correlated the level of fecal calprotectin with the final diagnosis they received. Results: 50/146 patients (34,24%) received a diagnosis of acute diverticulitis, in particular, 14/50 (28%) were complicated and 36/50 (72%) were uncomplicated; 4/146 (2,7%) were cholangitis, 32/146 (21,9%) were colitis, 6/146 (4,1%) gastritis, 42/146 (28,7%), Irritable bowel syndrome and 12/146 (8,2%) Inflammatory bowel disease. For the differential diagnosis between Irriable or inflammatory bowel diseses, our study showed a VPP and a VPN of 100% meanwhile for the differential diagnosis between Acute complicated and uncomplicated diverticulitis, our study showed a VPP of 40% and a VPN of 84%. Conclusion: In the emergency setting, faecal calprotectin could be a helpful marker to select patients with abdominal pain who need second-level radiological examinations or endoscopic procedures, guiding the emergency physician in the evaluation of such a complex and wideranging symptom.

Confidence interval (CI) is one of the important reporting tools for research data as it not only provides valuable information about the effect size along with its width but also possible clinical significance. Unfortunately, this approach is not being utilized to its fullest extent. Determining point estimate always includes an element of uncertainty due to associated sampling error. A confidence interval may be an appropriate tool to measure this uncertainty. Further, the P value does not convey information about the magnitude of an effect and the error associated with it. Thus, in an ideal situation effect size should preferably be associated with a confidence interval to assess precision. Not only does CI let us assess likely effects but also decides whether the intervention applied could have clinical utility. In contrast, the p-value limits our option to either reject any differences that are not significant or accept those that are. However, confidence intervals are commonly misinterpreted. It is imperative to understand that the CI is not the range of effects that 95% of patients in the population exhibit. Moreover, it would also be erroneous to say that there is a 95% probability that the CI includes the true population effect. Interpretation is usually based on the context in which the confidence interval is being looked at. From a utility point of view and like other statistical tools confidence interval approach does have several advantages as well as disadvantages and is far beyond being a perfect statistical tool.