Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

NCT05780099 | Recruiting

• 1 other identifier: MED-Cli
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Respiratory Disease; Cardiovascular Diseases; Infectious Disease; Critical Illness; Immunological Disease; Pregnancy Disease; Metabolic Syndrome; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with severe disease

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

  The following variables will be collected during patient enrollment

Study Arms (1)

Cases

patients treated at internal medicine wards

Other: Inpatient or Outpatient visit

Interventions

Inpatient or Outpatient visit OTHER

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

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in outpatient, inpatient or day hospital setting of internal medicine units at San Raffaele Hospital

You may qualify if:

• 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

You may not qualify if:

• refusal to participate
• enrolment in other intervantional study

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (2)

Ospedale San Raffaele

Milan, Italy

RECRUITING

San Raffaele Hospital

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Respiration Disorders; Cardiovascular Diseases; Communicable Diseases; Critical Illness; Immune System Diseases; Metabolic Syndrome; Chronic Disease

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Central Study Contacts

Patrizia Rovere Querini, PhD, MD

CONTACT

+390226436095; rovere.patrizia@hsr.it

Rebecca De Lorenzo, MD

CONTACT

+390226433065; delorenzo.rebecca@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 22, 2023
• Study Start: June 24, 2022
• Primary Completion (Estimated): September 10, 2031
• Study Completion (Estimated): September 10, 2032
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

IT (2)