Clinical trials: sponsored by Istituto Clinico Humanitas
Colonic Neoplasms
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of…
- Trial name
- SAVE (NCT06041945)
- Testing
- Standard, high-definition colonoscopy with the use of CADe assistance, Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ, Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
- Where
- 2 sites in Italy
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Istituto Clinico Humanitas
IPF, ILD
Photon-counting CT Scan vs Standard HRCT Scan in the Identification of Idiopathic Pulmonary Fibrosis
The CT-IPF ANTHEM study is designed to prospectively compare PCDCT to HRCT scan in the identification of specific ILD diagnosis discussed during the multidisciplinary discussion to increase diagnostic confidence and reduce…
- Conditions
- IPF, ILD, Interstitial Lung Disease (ILD), Interstitial Lung Diseases
- Trial name
- CT-IPF ANTHEM (NCT07790614)
- Testing
- Photon counting CT
- Where
- Italy
- Volunteers
- 156 people
- Sponsor
- Istituto Clinico Humanitas
Prostate Cancer
Photon-Counting Computed Tomography-Based Urethral Visualization Without Catheterization for Radiotherapy Planning: A Prospective Pilot Study Under ANTHEM
In prostate cancer radiotherapy, it is important to accurately identify and protect healthy organs near the prostate. One of these structures is the urethra, the tube that carries urine from the bladder out of the body.
- Trial name
- PURE-CT/ANTHEM (NCT07730203)
- Testing
- image acquisition
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Istituto Clinico Humanitas
Developing Acute Respiratory Distress Syndrome
Advanced Respiratory Monitoring for Safer Mechanical Ventilation in Patients Without Respiratory Failure
Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome…
- Trial name
- ADAPT (NCT07686315)
- Testing
- Advanced Non-Invasive Respiratory Monitoring
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Istituto Clinico Humanitas
Lung Surgery, Right Ventricular Function
RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery
Major pulmonary resection is associated with high postoperative morbidity and mortality, mainly due to cardiorespiratory complications.
- Trial name
- RIVER-2 (NCT07362342)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Istituto Clinico Humanitas
Serum Lactate Post-pancreatic Duodenectomy
Intra-operative Hypotension and Post-operative Lactate Level After Pancreatic-duodenectomy
Intraoperative hypotension is a frequent occurrence during pancreaticoduodenectomy (PD) and has been associated with impaired tissue perfusion and organ dysfunction.
- Trial name
- HYPOL (NCT07346274)
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Istituto Clinico Humanitas
Bloodstream Infection, Gram-Negative Infections
The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST)
The ACT-FAST study aims to compare commercially available Rapid Antimicrobial Susceptibility Testing (R-AST) tools with the current standard of care for patients with Bloodstream Infections (BSI).
- Conditions
- Bloodstream Infection, Gram-Negative Infections, Gram-Positive Infections, Bacteremia Sepsis
- Trial name
- ACT-FAST (NCT07491419)
- Testing
- Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship, Standard of Care (SOC)
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Istituto Clinico Humanitas
Head & Neck Cancer
REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors
Some patients with head and neck cancer may develop a tumor recurrence in an area that has already been treated with radiotherapy.
- Trial name
- REPROton-HN (NCT07635641)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Clinico Humanitas
Seminoma
PRISTINE Trial: PRoton Beam Therapy In Seminoma - Toxicity INvestigation and Evaluation of Outcome
Stage II seminoma is a type of cancer that is usually highly curable and most often affects young men. Radiotherapy is an effective treatment, but it can sometimes cause side effects in the long term and, rarely, increase the…
- Trial name
- PRISTINE (NCT07601672)
- Testing
- protontherapy
- Volunteers
- 20 people
- Sponsor
- Istituto Clinico Humanitas
Colorectal Cancer, Colorectal Surgery
Nutritional Supplementation to Improve Colorectal Cancer Surgery
This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional…
- Trial name
- NUTRICOLOR (NCT07599501)
- Testing
- Diet Optimization (DO), Oral Nutritional Supplement (ONS)
- Where
- Italy
- Volunteers
- 190 people
- Sponsor
- Istituto Clinico Humanitas
Acute Hypoxemic Respiratory Failure, Ventilation, Mechanical
Association Between EIT and CT During PEEP Titration in Patients With Acute Respiratory Failure
This observational study will analyze data already collected by the investigators as part of their routine clinical practice from patients with acute respiratory failure (ARF) treated with mechanical ventilation.
- Trial name
- TAC-EIT-20-5 (NCT07175194)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Istituto Clinico Humanitas
Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), Idiopathic Pulmonary Fibrosis (IPF)
Hereditary Influences on Pulmonary Fibrosis Trajectories
The SHIFT (Hereditary Influences on Pulmonary Fibrosis Trajectories) study is a prospective, multicenter, observational cohort study designed to investigate familial pulmonary fibrosis (FPF) within the Italian population.
- Conditions
- Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), Idiopathic Pulmonary Fibrosis (IPF), Telomere Disease, Progressive Pulmonary Fibrosis
- Trial name
- SHIFT (NCT07580053)
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Istituto Clinico Humanitas
Interstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder)
Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases.
The OCEAN-ILD study is designed to prospectively evaluate the prevalence and clinical relevance of environmental and occupational exposures in a large Italian cohort of patients affected by any ILD, using a standardised exposure…
- Conditions
- Interstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), Exposure Occupational, Occupational Exposure
- Trial name
- OCEAN-ILD (NCT07577115)
- Testing
- standard interview
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Istituto Clinico Humanitas
Bladder Cancer, Urothelial Carcinoma (UC)
Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA
Bladder cancer is the most common type of urothelial cancer. When the disease has spread to other parts of the body (metastatic disease), the prognosis is often poor, because there are only a few effective treatment options…
- Conditions
- Bladder Cancer, Urothelial Carcinoma (UC), Oligometastasis
- Trial name
- ASTRA (NCT07413523)
- Testing
- SBRT
- Where
- Italy
- Volunteers
- 44 people
- Sponsor
- Istituto Clinico Humanitas
Pancreas Cancer
Stereotactic PAncreatic RadioTherapy Adjuvant Therapy
While surgery is considered the only potentially curative therapy for pancreatic cancer, 5-year overall survival (OS) is typically <25%.
- Trial name
- SPARTA (NCT05043857)
- Testing
- Stereotactic Body Radiotherapy (SBRT)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Clinico Humanitas
Head and Neck Cancer
AI for Head Neck Cancer Treated With Adaptive RadioTherapy (RadiomicART)
Current clinical management algorithms for squamous cell carcinoma of head and neck (HNSCC) involve the use of surgery and / or radiotherapy (RT) depending on the stage of the disease at diagnosis.
- Trial name
- RadiomicArt (NCT05081531)
- Testing
- Adaptive Radiotherapy
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Clinico Humanitas
Brain Metastases, Adult
Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases
This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors suitable for surgical resection.
- Trial name
- SUPPORT (NCT05545007)
- Testing
- Hypofractionated Radiosurgery (HSRS), Brain metastases surgical resection
- Where
- 9 sites in Italy
- Volunteers
- 146 people
- Sponsor
- Istituto Clinico Humanitas
Precancerous Lesions
This Randomized, Single-center Trial Aims to Evaluate the Advantages of Underwater ESD (U-ESD) in Comparison to the Conventional ESD (C-ESD).
Large nonpedunculated colorectal lesions are increasingly detected thanks to screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps.
- Trial name
- Wave-ESD (NCT07040020)
- Testing
- Underwater ESD (U-ESD), Conventional ESD (C-ESD)
- Where
- Italy
- Volunteers
- 122 people
- Sponsor
- Istituto Clinico Humanitas
Polyneuropathies
ChatGPT in the Diagnosis and Management of Complex Polyneuropathies: Comparative Analysis With Neurologists Using Real-World Cases
BACKGROUND AND PURPOSE Polyneuropathies are diseases affecting the peripheral nerves that occur in approximately 1% of the general population, rising to up to 13% among older adults.
- Trial name
- REASON (NCT07493681)
- Testing
- ChatGPT-4o, chatGPT
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Istituto Clinico Humanitas
Critical Illness Polyneuromyopathy, Critical Illness Polyneuropathy
Critical Illness Weakness Outside the Intensive Care Unit.
When people become seriously ill, their bodies can be affected in many ways beyond the original disease. One well-known complication in patients treated in intensive care units (ICUs) is the development of severe muscle weakness…
- Conditions
- Critical Illness Polyneuromyopathy, Critical Illness Polyneuropathy, Critical Illness Myopathy
- Trial name
- CRI-WEAK-OUT (NCT07478367)
- Testing
- No Intervention: Observational Cohort
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Istituto Clinico Humanitas