Development and Validation of a META-Algorithm to Identify the Indications of Use of Biological Drugs Approved for the Treatment of Immune-Mediated Inflammatory Diseases from Claims Databases: Insights from the VALORE Project.

Purpose: This research aimed to develop and validate a META-algorithm combining individual immune-mediated inflammatory disease (IMID)-specific algorithms to identify the exact IMID indications for incident biological drug users from claims data within the context of the Italian VALORE project.

Methods And Patients: All subjects with at least one dispensing of TNF-alpha inhibitors, anti-interleukin agents, and selective immunosuppressants approved for IMIDs were identified from claims databases of Latium region in Italy (observation period: 2010-2020). Validated coding algorithms for identifying individual IMIDs from claims databases were found from published literature and combined into a META-algorithm.

Switching patterns of biological drugs in patients with psoriasis and psoriatic arthritis: insight from the VALORE database network.

Background: Switch patterns among different biologics and from originators to biosimilars (and vice versa) can be complex in patients with psoriasis (PsO) and psoriatic arthritis (PsA).

Objective: The aim of this study was to describe switching patterns of biological drugs in PsO/PsA patients and to explore predictors of multiple switches and switch-back.

Research Design And Methods: A large-scale retrospective cohort study was conducted using the Italian VALORE database.

Comparing clinical trial population representativeness to real-world users of 17 biologics approved for immune-mediated inflammatory diseases: An external validity analysis of 66,639 biologic users from the Italian VALORE project.

To date, no population-based studies have specifically explored the external validity of pivotal randomized clinical trials (RCTs) of biologics simultaneously for a broad spectrum of immuno-mediated inflammatory diseases (IMIDs). The aims of this study were, firstly, to compare the patients' characteristics and median treatment duration of biologics approved for IMIDs between RCTs' and real-world setting (RW); secondly, to assess the extent of biologic users treated for IMIDs in the real-world setting that would not have been eligible for inclusion into pivotal RCT for each indication of use. Using the Italian VALORE distributed database (66,639 incident biologic users), adult patients with IMIDs treated with biologics in the Italian real-world setting were substantially older (mean age ± SD: 50 ± 15 years) compared to those enrolled in pivotal RCTs (45 ± 15 years).

Immune landscape and oncobiota in HPV-Associated Colorectal Cancer: an explorative study.

Worldwide more than 550,000 new patients suffering from malignant tumors are associated with human papillomaviruses (HPV) infection. However, only a small portion of patients infected progress to cancer, suggesting that other factors other than HPV may play a role. Some studies have investigated HPV infection in colorectal cancer (CRC) with discordant results; moreover, the role of HPV in CRC development is still unknown.

Mixed mucinous adenocarcinoma/large cell neuroendocrine carcinoma of the uterine cervix: case report and molecular characterization of a rare entity.

Mixed neuroendocrine-non-neuroendocrine carcinomas of the cervix are rare and generally aggressive diseases. They often present at an advanced stage with hematogenous or lymphatic metastases. The prognosis is poor, mostly influenced by the neuroendocrine component.

Paving the Path for Immune Enhancing Nutrition in Colon Cancer: Modulation of Tumor Microenvironment and Optimization of Outcomes and Costs.

Introduction: Published evidence suggests that immunonutrition has the potential to decrease postoperative complications and reduce length of stay in patients undergoing surgery for colorectal cancer. However, only a few studies have analyzed the effects of immunonutrition on tumor microenvironment and evaluated its prognostic impact.

Material And Methods: This is a single center retrospective study enrolling 50 patients undergoing elective surgery for colorectal cancer managed with immunonutrition and 50 patients managed with standard nutrition for comparison.

Peripancreatic paraganglioma: Lesson from a round table.

We described the case of a peripancreatic paraganglioma (PGL) misdiagnosed as pancreatic lesion. Surgical exploration revealed an unremarkable pancreas and a large well-defined cystic mass originating at the mesocolon root. Radical enucleation of the mass was performed, preserving the pancreatic tail.

Correlation between olfactory function, age, sex, and cognitive reserve index in the Italian population.

Purpose: Loss of smell decreases the quality of life and contributes to the failure in recognizing hazardous substances. Given the relevance of olfaction in daily life, it is important to recognize an undiagnosed olfactory dysfunction to prevent these possible complications. Up to now, the prevalence of smell disorders in Italy is unknown due to a lack of epidemiological studies.

Surgeon-Pathologist Team Approach Dramatically Affects Lymph Nodes Detection and Improves Patients' Short-Term Outcome.

The downstaging of gastric cancer has recently gained particular attention in the field of gastric cancer surgery. The phenomenon is mainly due to an inappropriate sampling of lymph nodes during standard lymphadenectomy. Hence, collection of the maximum number of lymph nodes is a critical factor affecting the outcome of patients.

A look towards the clonal origin of metastatic pulmonary carcinosarcoma: Report of a patient with an unexpected long-term survival.

Introduction: Pulmonary carcinosarcoma is a rare histological subtype of non-small cell lung cancer, defined by the combination of epithelial and mesenchimal elements. Prognosis is usually dismal, with a median survival of about 6 months. The use of immunotherapy by blockade of PD1/PD-L1 immune checkpoint signaling has been shown to improve patients' survival.

Arousal influences olfactory abilities in adults with different degree of food neophobia.

Food neophobia, i.e., the aversion to novel foods, and olfaction are both factors strongly affecting food choices.

Specific intranasal and central trigeminal electrophysiological responses in Parkinson's disease.

Olfactory dysfunction is a frequent early non-motor symptom of Parkinson's disease (PD). There is evidence that with regard to trigeminal perception, PD-related olfactory dysfunction is different from other olfactory disorders. More specifically, trigeminal sensitivity, when measured behaviorally, was unimpaired in PD patients as opposed to patients with non-Parkinsonian olfactory dysfunction (NPOD).

The scent of the other women: Body odor-induced behavioral and physiological effects on face categorization.

In body odor research, the interaction of female donors and receivers is scarcely investigated. With the aim to investigate effects of female body odor in a competitive context, we tested 51 women divided into two groups (i.e.

Neural processing of odor-associated words: an fMRI study in patients with acquired olfactory loss.

Perception of olfactory information is mediated by both bottom-up (from molecules to perception) and top-down (e.g. cross-modal associative learning) processes.

Detection thresholds for quinine, PTC, and PROP measured using taste strips.

Purpose: In clinical practice, when ability to perceive bitter taste is studied, quinine is preferred to phenylthiocarbamide (PTC) and 6-n-propylthiouracil (PROP) as taste stimulus, because many subjects are genetically non-tasters for PTC/PROP. However, it is poorly known how sensitive anterior (front) and posterior (back) parts of the tongue are to different bitter tastants that are detected by different bitter taste receptors (TAS2Rs). In the present study, we aimed to characterize sensitivity to bitter taste at front and back parts of tongue.

Sensory-specific impairment among older people. An investigation using both sensory thresholds and subjective measures across the five senses.

Age-related sensory impairment is a slow and gradual progress, which affects multiple modalities. Two contradictory hypotheses exist about the age-related decline of sensory thresholds. The common factor theory assumes one underlying factor-which accounts for the loss of several sensory modalities simultaneously-and the specific factor theory predicts that the sensory decline is uncorrelated between different modalities.

Correlation among olfactory function, motors' symptoms, cognitive impairment, apathy, and fatigue in patients with Parkinson's disease.

Although Parkinson's disease (PD) is usually considered as a movement disorder, it is strongly associated with non-motor symptoms (NMS), including smell and taste dysfunctions, cognitive impairment, apathy, fatigue, and autonomic dysregulation. Olfactory deficit is considered the most common NMS in PD preceding the motor symptoms for years. The aim of this study was to investigate olfactory function, cognitive impairment, apathy, and fatigue in patients with PD in comparison with healthy controls, and subsequently to analyse the correlations between these NMS and motor symptoms severity in subjects with PD.

Electro-olfactogram Responses Before and After Aversive Olfactory Conditioning in Humans.

The aim of the present study was to investigate whether repetitive aversive odor conditioning induced changes at the level of the peripheral olfactory system in humans. A total of 51 volunteers participated. A pair of indistinguishable odor enantiomers [(+)-rose oxide and (-)-rose oxide] were used as stimuli.

Indistinguishable odour enantiomers: Differences between peripheral and central-nervous electrophysiological responses.

The ability of humans to discriminate enantiomeric odour pairs is substance -specific. Current literature suggests that psychophysical discrimination of odour enantiomers mainly depends on the peripheral processing at the level of the olfactory sensory neurons (OSN). To study the influence of central processing in discrimination, we investigated differences in the electrophysiological responses to psychophysically indistinguishable (+)- and (-)- rose oxide enantiomers at peripheral and central-nervous levels in humans.

Postinfectious olfactory loss: A retrospective study on 791 patients.

Objectives/hypothesis: Postinfectious olfactory loss is among the most common causes of olfactory impairment and has substantial negative impact on patients' quality of life. Recovery rates have been shown to spontaneously improve in most of patients, usually within 2 to 3 years. However, existing studies are limited by small sample sizes and short follow-up.