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NCT Number: NCT05780099

Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

Patients referred to internal medicine wards are becoming increasingly complex and fragile. Despite deep knowledge of their specific disorders, steps are required to improve overall management of their acute and chronic conditions. The main objective of the study is to identify demographic, clinical, laboratory and radiological markers of disease severity and activity in patients with diseases treated at general medicine wards (respiratory disease, immune-mediated disease, sepsis, metabolic disease, rare disease, frailty, pregnancy pathology) in order to improve their diagnosis, monitoring and treatment processes.

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Key information

About this study

Among the most prevalent internal diseases worldwide are metabolic, respiratory and infectious diseases. Despite important progress in the field of these diseases, their frequent coexistence leads to a state of so-called fragility, now recognised as a genuine pathological condition, and entails the need to optimise their management in order to ensure faster and more effective diagnostic processes and targeted treatment procedures. On the other hand, those less frequent and less defined from both a pathogenetic and a management point of view include immune-mediated diseases, rare diseases, and internist disorders of pregnancy. Many times, diagnostic and therapeutic algorithms validated for specific diseases are arbitrarily applied to less common diseases based on the similarity of the clinical picture. For example, indices of inflammation such as C-reactive protein and erythrocyte sedimentation rate, traditionally used as markers of inflammatory response to infection, are commonly used as surrogate markers of disease activity in non-infectious immune-mediated diseases, despite the fact that there are no studies demonstrating their specific usefulness in patients suffering from them. This often leads to inappropriate care choices, as they are not based on sufficient degrees of evidence for those specific diseases. Studies focusing on specific disease categories are necessary to identify disease-specific markers and thus target therapy in an informed manner. Both the most prevalent and the least characterised pathologies require the integrated work of third-level centres, such as the San Raffaele Hospital, which have a large number of patient referrals and can therefore make a concrete contribution to the advancement of knowledge of these pathologies and their management and make their mark in the international scientific community. To this end, a prospective observational study is being conducted aimed at the detailed characterisation of patients suffering from these pathologies, in order to identify possible risk factors and markers of severity that can guide the development of new diagnostic and therapeutic strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receving treatment at internal medicine departments (inpatient, outopatient, day hospital) of San Raffaele Hospital
  • at least one suspected or confirmed diagnosis among:
  • immune mediated disorder
  • respiratory disorder
  • metabolic disorder
  • sepsis
  • rare disorder (according to Italian Ministry of Health list)
  • pregnancy-related disorder
  • frailty defined as: either ≥2 CIRS (Cumulative Illness Rating Scale) Severity Index 10 or ≤70% Karnofsky scale

Exclusion criteria

  • refusal to participate
  • enrolment in other intervantional study

Treatment and study plan

Inpatient or Outpatient visit

Other

Patients will be seen and treated at the clinics like in the usual care

Primary outcomes

  1. Number of participants with severe disease

    Time frame: The following variables will be collected during patient enrollment

    Identify demographic, clinical, laboratory and radiological markers of disease severity and activity

Study contacts

Contact information is provided by the study sponsor or research team.

Patrizia Rovere Querini, PhD, MD

CONTACT

[email protected]

+390226436095

Rebecca De Lorenzo, MD

CONTACT

[email protected]

+390226433065

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: MED-Cli

Important dates

Study start
2022
Primary completion
2031
Study completion
2032
First posted
Mar 22, 2023
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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