Reviews on Recent Clinical Trials - Volume 17, Issue 4, 2022

Inflammatory Bowel Diseases (IBDs) are chronic, relapsing and disabling diseases that affect the gastrointestinal tract. This relapsing course is often unpredictable with severe flares and the need for intensive medical treatment, hospitalization, or emergent/urgent surgery, all of which significantly impact patients’ quality of life (QoL). QoL in IBD patients is significantly lower than in the general population, and depression and anxiety have been shown to have a higher prevalence than in healthy individuals, especially during disease flares. Complications requiring hospitalization and repeated surgeries are not uncommon during the disease course and significantly affect QoL in IBD patients. Patient-reported outcome measures (PROMs) can be used to measure the impact of chronic disease on QoL from the patient’s perspective. The use of PROMs in IBD patients undergoing surgery could help to investigate the impact of the surgical procedure on QoL and determine whether there is any improvement or worsening. This review summarizes the use of PROMs to assess QoL after various surgical procedures required for IBD treatment.

The gut microbiota is one of the great innovations of modern medicine. In the modern microbiota revolution era, more comprehensive and in-depth studies have been performed regarding the microbial gut communities and their impact on acute and chronic diseases, including those of the nervous system as acute neurological diseases. The microbiota has changed our knowledge of medical conditions; in particular, considering stroke (both ischemic and hemorrhagic), literature studies, experimental and clinical researches indicate that the individual’s risk and outcomes are substantially impacted by the gut microbiota. The aim of our review article is to investigate and discuss the recent insights into the emerging role of this complex “gut microbiota-brain axis” in affecting some acute neurological diseases, such as stroke, responsible for a significant number of deaths worldwide. We performed electronic research on PubMed® and collected articles published in the last ten years, finding that changes in the gut microbiota composition could affect various aspects of stroke pathophysiology and individual predisposition, risk, and outcomes. Our review article suggests that there is a strong connection between the gut microbiota and the brain, both in health and in acute neurological diseases such as stroke. Investigating and exploring this relationship can be a challenge useful to learn more about this disabling/deadly condition, and it can be a useful tool to identify novel potential therapeutic approaches, improving an individual’s outcomes and life.

Head trauma and delirium are two common conditions in the elderly population. They both carry a heavy burden in terms of mortality and morbidity and are associated with one another through several environmental and clinical factors, such as comorbidities, age, and sex. One factor that may play a role in both these conditions is inflammation, which might also represent a link between them. In particular, head trauma can cause both systemic and neuroinflammation, while delirium appears to be precipitated by inflammatory conditions, while also involving a number of inflammatory pathways in its pathogenesis. Interleukin 6 and tumor necrosis factor α are only two of the main actors in this crosstalk, which also involves microglia and immune cells. An indirect proof is that anti-inflammatory drugs have proven effective in reducing post-traumatic delirium, thus demonstrating the importance of inflammation in the pathophysiology of this disease. In this paper, we have revised the available literature exploring the links between inflammation, head trauma and delirium and we will discuss the mechanisms of this relationship, paying particular attention to the possible future implications.

Patients affected by inflammatory bowel disease (IBD) frequently report impaired quality of sexual life and complain of sexual dysfunctions. Both disease-specific features and psychological factors can be held responsible for these conditions. However, sexuality and all matters relating to sexual health are often wrongfully considered unrelated to IBD and, therefore, overlooked during medical visits. To overcome these difficulties and to best assess patients’ perceptions about their sexual health status, the use of patient-reported outcomes (PROs) could represent a valid strategy. In real-world studies, several non-IBD specific questionnaires, exploring different domains of sexuality, have been applied and validated for the IBD population. This review summarizes the available evidence on sexual health among IBD patients and the data supporting the application of PROs to screen the quality of sexual life, as well as the rate and types of sexual dysfunctions, among IBD patients.

Viral infections of the central nervous system cause frequent hospitalization. The pathogenesis of viral encephalitis involves both the direct action of invading pathogens and the damage generated by the inflammatory reaction they trigger. The type of signs and symptoms presented by the patient depends on the severity and location of the ongoing inflammatory process. Most of the viral encephalitides are characterized by an acute development, fever, variable alterations in consciousness (confusion, lethargy, even coma), seizures (focal and generalized) and focal neurologic signs. The specific diagnosis of encephalitis is usually based on lumbar puncture. Cerebrospinal fluid examination should be performed in all patients unless absolutely contraindicated. Also, electroencephalogram and neuroimaging play a prominent role in diagnosis. Airway protection, ventilatory support, the management of raised intracranial pressure and correction of electrolyte disorders must be immediately considered in a patient with altered mental status. The only therapy strictly recommended is acyclovir in HSV encephalitis. The use of adjunctive glucocorticoids has poor-quality evidence in HSV, EBV, or VZV encephalitis. The role of antiviral therapy in other types of viral encephalitis is not well defined.

Background: Traumatic brain injury (TBI) can be considered a "silent epidemic", causing morbidity, disability, and mortality in all age cohorts. Therefore, a greater understanding of the underlying pathophysiological intricate mechanisms and interactions with other organs and systems is necessary to intervene not only in the treatment but also in the prevention of complications. In this complex of reciprocal interactions, the complex brain-gut axis has captured a growing interest. Scope: The purpose of this manuscript is to examine and systematize existing evidence regarding the pathophysiological processes that occur following TBI and the influences exerted on these by the brain-gut axis. Literature Review: A systematic review of the literature was conducted according to the PRISMA methodology. On the 8th of October 2021, two independent databases were searched: PubMed and Scopus. Following the inclusion and exclusion criteria selected, 24 (12 from PubMed and 12 from Scopus) eligible manuscripts were included in the present review. Moreover, references from the selected articles were also updated following the criteria mentioned above, yielding 91 included manuscripts. Discussion: Published evidence suggests that the brain and gut are mutually influenced through four main pathways: microbiota, inflammatory, nervous, and endocrine. Conclusion: These pathways are bidirectional and interact with each other. However, the studies conducted so far mainly involve animals. An autopsy methodological approach to corpses affected by traumatic brain injury or intestinal pathology could represent the keystone for future studies to clarify the complex pathophysiological processes underlying the interaction between these two main systems.

Background: Type 2 diabetes is a metabolic disease characterized by hyperglycemia as a result of insulin resistance and decreased insulin secretion. A relatively large number of patients with this type of diabetes have abdominal obesity, which also affects insulin resistance development. Chronic hyperglycemia can lead to damage and dysfunction of various organs, and a striking example is diabetic nephropathy. Diabetic nephropathy is a specific kind of kidney damage that occurs due to complications of diabetes and is accompanied by the formation of diffuse or nodular glomerulosclerosis, which can lead to terminal renal failure and requires immediate substitution through renal therapy or renal transplantation. Diabetic nephropathy is diagnosed with albuminuria and a decrease in the rate of glomerular filtration. Methods: This review was based on a literature search for the most important evidence of vitamin D as a possible method of prevention for obesity, type 2 diabetes, and diabetic nephropathy. Collected published articles were summarized according to their overall themes. Results: In this review, we considered vitamin D as a possible method of treatment for type 2 diabetes, as well as its complications, including diabetic nephropathy. Conclusion: Studies show that vitamin D inhibits the renin-angiotensin-aldosterone system, resulting in improved renal function in diabetic nephropathy. Vitamin D also has antiinflammatory, antiproliferative, and anti-metastatic effects, which improve endothelial function.

Aims: Cancer is a high-mortality disease (9.6 million deaths in 2018 worldwide). Given various anticancer drugs, drug selection plays a key role in patient survival in clinical trials. Methods: Drug Sensitivity Testing (DST), one of the leading drug selective systems, was widely practiced for therapeutic promotion in the clinic. Notably, DSTs assist in drug selection that benefits drug responses against cancer from 20-22% to 30-35% over the past two decades. The relationship between drug resistance in vitro and drug treatment benefits was associated with different tumor origins and subtypes. Medical theory and underlying DST mechanisms remain poorly understood until now. The study of the clinical scenario, sustainability and financial support for mechanism and technical promotions is indispensable. Results: Despite the great technical advance, therapeutic prediction and drug selection by DST needs to be miniature, versatility and cost-effective in the clinic. Multi-parameters and automation of DST should be a future trend. Advanced biomedical knowledge and clinical approaches to translating oncologic profiles into drug selection were the main focuses of DST developments. With a great technical stride, the clinical architecture of the DST platform was entering higher levels (drug response testing at any stage of cancer patients and miniaturization of tumor samples). Discussion: The cancer biology and pharmacology for drug selection mutually benefit the clinic. New proposals to reveal more therapeutic information and drug response prediction at genetic, molecular and omics levels should be estimated overall. Conclusion: By upholding this goal of non-invasive, versatility and automation, DST could save the life of several thousand annually worldwide. In this article, new insights into DST novelty and development are highlighted.