The Requirements of Managing Phase I Clinical Trials Risks: The British and Italian Case Studies.

Phase I clinical trials represent a critical point in drug development because the investigational medicinal product is being tested in humans for the first time. For this reason, it is essential to evaluate and identify the Maximum Tolerated Dose (MTD) and the safety of the new compound. To mitigate the possible risks associated with drug administration and treatment, the European Competent Authority issued various guidelines to provide provisions and harmonize risk management processes.

Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries.

Background: Phase 1 clinical trials represent a critical phase of drug development because new candidate therapeutic agents are tested for the first time on humans. Therefore, international guidelines and local laws have been released to mitigate and control possible risks for human health in agreement with the declaration of Helsinki and the international Good Clinical Practice principles. Despite numerous scientific works characterizing the registered clinical trials on ClinicalTrials.

The Problems and Contradictions Inherent in Analytic Training and the Ultimate Requirement: Working with Uncertainty.

In this essay, the author's aim is to outline the specifics of psychoanalytic intervention and its current relevance. She explores the boundaries of the clinician's identity, (whether psychotherapist or psychoanalyst), examines the training itself, as well as how and where one can develop the skills necessary to engage in this profession. She specifically assesses the Italian situation.

Retrospective analysis of the effectiveness and costs of traditional treatments for moderate-to-severe psoriasis: A single-center, Italian study.

Background: Current guidelines recommend the use of systemic therapy and phototherapy for the treatment of moderate-to-severe plaque psoriasis.

Objectives: To evaluate the effectiveness, impact on health status perception, and costs of traditional systemic therapies and phototherapy in real-life patients with moderate-to-severe psoriasis.

Methods: Retrospective analysis of data from 100 psoriatic patients referring to a dermatology clinic in Italy and treated with traditional therapies.

Personality profiles and coping styles in migraine patients with fibromyalgia comorbidity.

Fibromyalgia syndrome (FM) is frequently associated with migraine. In this study we aimed to compare personality profiles and coping styles across 23 migraine without aura patients sharing FM comorbidity (MWA-FM), 28 migraine without aura patients without FM symptoms (MWA) and 51 age- and sex-matched controls, by means of Big Five Questionnaire (BFQ) and Coping Orientation to Problem Experienced (COPE), and to correlate main results with clinical features. The "Energy" personality factor was significantly reduced in patients presenting with FM symptoms, compared to both migraine without aura patients and controls.