1.
ClinicalTrials.gov; 25/01/2024; TrialID: NCT06234449
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06234449
ABSTRACT
Condition:
Pelvic Organ Prolapse;Vaginal ProlapseIntervention:
Procedure: Vaginal pessary before surgery for pelvic organ prolapsePrimary outcome:
evaluate a change in POPQ points on examination at the time of surgery from baseline evaluation.Criteria:
Inclusion Criteria:
- Pelvic organ prolapse with POP-Q stage >/= 3 in anterior and/or central compartments
- Women between 45 and 80 years old
Exclusion Criteria:
- Women who refuse to participate in the study
- Patients without baseline POPQ examination documented or with a pessary previously
positioned
- Previous pelvic surgeries
- Women with any contraindication for surgery or preference for conservative treatment
only (pelvic muscle exercise, vaginal pessary)
- Women who are not successfully fitted with pessaries
- Current genital ulcers/infections
- Active or chronic pelvic infection
- Women who are mentally incapable of completing the questionnaires.
2.
ClinicalTrials.gov; 18/12/2023; TrialID: NCT06177002
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06177002
ABSTRACT
Condition:
COVID-19;Testosterone Deficiency;Infertility, MaleIntervention:
Diagnostic Test: Collection of biological dataPrimary outcome:
Dosage of the androgenic hormonal environment in the blood of patients and healthy controlsCriteria:
Inclusion Criteria:
Patient Cohort:
- Male patients with an age > 18 hospitalized in the departments dedicated to the care
of patients affected by COVID-19 at the San Raffaele Hospital and with:
- biological samples positive for SARS-CoV-2;
- negative test but highly suggestive clinical and radiological picture;
- patients discharged from the emergency room with biological samples positive for
SARS-CoV-2;
- ability to read and sign the informed consent
Control Cohort:
- healthy donors with an age> 18 accessing the IRCCS OSR Blood Donor Center;
- ability to read and sign the informed consent
Exclusion Criteria:
- People with an age < 18;
- incapacity to read and sign the informed consent
3.
ClinicalTrials.gov; 12/03/2023; TrialID: NCT05770336
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05770336
ABSTRACT
Condition:
Cardiac Complication;COVID-19 PneumoniaPrimary outcome:
Identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage.Criteria:
Inclusion Criteria:
- Patient with previous hospitalization for Covid-19 infection confirmed by pharyngeal
molecular swab
- Adult patients between 18 and 90 years of age
- Signature of informed consent
Exclusion Criteria:
- Patient with poor echocardiographic acoustic window impairing the performance of the
examination
- Patients with atrial fibrillation
- Patients with ischemic or nonischemic heart disease with known decreased left
ventricular systolic function
4.
ClinicalTrials.gov; 30/01/2023; TrialID: NCT05706038
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05706038
ABSTRACT
Condition:
Inflammatory Bowel Diseases;Rheumatic DisorderIntervention:
Drug: AdalimumabPrimary outcome:
composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or deathCriteria:
Inclusion Criteria:
1. age = 18 years
2. diagnosis of immune-mediated inflammatory disease:
1. IBD: CD, UC or undetermined colitis
2. Rheumatic diseases: RA, PsA, axSpA, and nrx SpA
3. patients treated with adalimumab for IMID at time of SARS-CoV-2 infection diagnosis
4. COVID-19 positive PCR test
5. minimum treatment duration on adalimumab of 3 months before SARS-CoV-2 infection
diagnosis
6. minimum follow-up of one month after SARS-CoV-2 infection diagnosis
Exclusion Criteria:
1. Adalimumab withdrawal for other reasons than SARS-CoV-2 infection
2. Patients with COPD or lung co-morbidities
3. Pregnant, parturient, or breastfeeding woman
4. Minor person (non-emancipated)
5. Adult person under legal protection (any form of public guardianship)
6. Adult person incapable of giving consent and not under legal protection
7. Person deprived of liberty for judicial or administrative decision, person under
psychiatric care as referred in articles L. 3212-1 and L. 3213-1 of the Public Health
Code.
5.
Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-CoV-2 Infection (COVID-19)
ClinicalTrials.gov; 07/03/2022; TrialID: NCT05276388
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05276388
ABSTRACT
Condition:
Coronavirus InfectionsIntervention:
Other: biological bankPrimary outcome:
COVID-19 vaccines responseCriteria:
Inclusion Criteria:
- Age =18 years
- Who have vaccinated for SARS-CoV-2 with Pfizer-BioNTech vaccine or others
- Signing of informed consent from January to March 2021
Exclusion Criteria:
- none
6.
ClinicalTrials.gov; 09/11/2021; TrialID: NCT05115097
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05115097
ABSTRACT
Condition:
COVID-19;COVID-19 Respiratory Infection;Cough;Breathing Sound;Breathing, MouthPrimary outcome:
Accuracy evaluationCriteria:
Inclusion Criteria:
- Adults who tested positive for SARS-CoV-2
- Currently admitted to hospital at the study site
Exclusion Criteria:
- Patients under the age of 18.
- Patients unable to read in Italian.
- Patients unable to give informed consent to participate.
- Patients requiring life support (including, but not limited to, mechanical cardiac
support, ventilation, etc.)
- Patients who are pregnant
7.
ClinicalTrials.gov; 28/10/2021; TrialID: NCT05102669
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05102669
ABSTRACT
Condition:
COVID19;Vaccination;Immune ResponseIntervention:
Other: analysis of immunological response;Diagnostic Test: analysis of serum antibodiesPrimary outcome:
measurement of cellular responseCriteria:
Inclusion Criteria:
- vaccinated and non vaccinated subjects
- subjects that never tested positive for COVID19
Exclusion Criteria:
- subjects that tested positive for COVID-19
8.
ClinicalTrials.gov; 31/05/2021; TrialID: NCT04913701
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04913701
ABSTRACT
Condition:
SARS-Cov2Intervention:
Other: Observation group 1Primary outcome:
Number of participants with positive RT-PCR against SARS-CoV2Criteria:
Inclusion Criteria:
- Patients/Participants > 18 years
- Subjects who agree with the study signing the informed consent
Exclusion Criteria:
- Age <18 years;
- Pregnancy in progress;
- Simultaneous participation in another clinical study
- Ongoing immunosuppressive therapy or during the last month
9.
ClinicalTrials.gov; 22/04/2021; TrialID: NCT04890600
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04890600
ABSTRACT
Condition:
Distress, Emotional;Coping BehaviorIntervention:
Behavioral: well-being assessmentPrimary outcome:
Levels of anxiety and depression;Coping strategies;Levels of resilience;Levels of fear of COVID-19Criteria:
Inclusion Criteria:
- Healthworkers of San Raffaele Institution
- age>18
Exclusion Criteria:
- all those who do not agree
10.
ClinicalTrials.gov; 06/04/2021; TrialID: NCT04834934
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04834934
ABSTRACT
Condition:
Covid19Primary outcome:
Training, testing and validation of an AI platform for predicting Italian first wave Covid-19 patients prognosis.Criteria:
Inclusion Criteria:
- confirmed SARS-CoV-2 infection with RT-PCR
- non contrast chest CT scan performed within 72 hours after admission to the emergency
department
Exclusion Criteria:
- age < 18 ys
11.
ClinicalTrials.gov; 25/02/2021; TrialID: NCT04775784
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04775784
ABSTRACT
Condition:
COVID-19 Testing;CNS Disease;CNS InfectionIntervention:
Diagnostic Test: Determination of SARS-CoV2 presence in CNSPrimary outcome:
Determination of SARS-CoV-2 presence in the CNSCriteria:
Inclusion Criteria:
- Adult patients
- Patients candidate for CNS surgery
- Patients who have been tested for nasopharyngeal swab for SARS-CoV-2
- Patients who have been tested for serology test for anti SARS-CoV-2 immunoglobulinG
(IgG) and immunoglobulinM (IgM) antibodies
- Patients able to sign informed consent
Exclusion Criteria:
- Patients not meeting inclusion criteria
12.
ClinicalTrials.gov; 13/01/2021; TrialID: NCT04712448
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04712448
ABSTRACT
Condition:
Healthy;Chronic DiseaseIntervention:
Diagnostic Test: Anti-COVID testPrimary outcome:
Seroprevalence of antibodies anti-COVID-19Criteria:
Inclusion Criteria:
- Both sexes
- Age >18 years
- Signed informed consent for the donation / sample storage in the Biological Bank
Exclusion Criteria:
- for healthy subjects: all those who have shown any symptoms, albeit mild, in the 28
days prior to the donation.
- for patients: who have not signed the informed consent for the conservation of their
samples in the Biological Bank.
13.
ClinicalTrials.gov; 21/05/2020; TrialID: NCT04410549
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04410549
ABSTRACT
Condition:
Covid19;Pulmonary EmbolismIntervention:
Diagnostic Test: Optical Coherence Tomography (OCT)Primary outcome:
optical coherence tomography pulmonary microthrombosis assessment in COVID-19 pneumonia patientsCriteria:
Inclusion Criteria:
(part A)
- Severe pulmonary coronarvirus disease 19 (COVID 19) with suspect for MicroCLOTS
(microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome) AND
- Contrast CT scan negative for pulmonary thrombosis AND
- D-Dimer > 10 mcg/mL OR
- 5 < D-dimer < 10 mcg/mL and either C Reactive Protein (CRP) > 100 mg/dL or IL-6 > 6
pg/mL or ferritin > 900 ng/L
(part B)
- Severe pulmonary coronarvirus disease 19 (COVID 19) with suspect for MicroCLOTS
(microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome) AND
- Contrast CT scan positive for pulmonary thrombosis
Exclusion Criteria:
- Age < 18
- Pregnancy or breastfeeding
- Known allergy to iodinated contrast dye
- Hemodynamic instability
- Glomerular Filtration rate < 30 ml/min
- Active bleeding or absolute contraindication to anticoagulant therapy
14.
ClinicalTrials.gov; 05/05/2020; TrialID: NCT04377776
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04377776
ABSTRACT
Condition:
Kidney Transplant;Pancreas Tranplant;Pancreatic Islet TransplantationIntervention:
Other: Practice detailsPrimary outcome:
Global Prevalence of COVID-19 TX;Hospitalization rate in COVID-19 TXCriteria:
Inclusion Criteria:
Transplanted Kidney or Kidney/Pancreas or Pancreas or Pancreatic Islet patients at
Transplant Medicine Unit - San Raffaele Scientif Institute
15.
ClinicalTrials.gov; 31/03/2020; TrialID: NCT04335201
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04335201