louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06304038: Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome
Official title: Cost-consequence Analysis of Influenza Vaccination Among the Staff of a Large Teaching Hospital in Rome, Italy: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Vaccine
Cost-Benefit Analysis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 5483
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is represented by all employed healthcare workers of the FPG amounting to approximately 5000 (data provided by the Human Resources Department of the Hospital in December 2017).

The case group consists of all healthcare workers vaccinated in the 2017-2018 season at the specially designated facilities within the Teaching Hospital, filed on special registers.

The control group consists of healthcare workers who were not vaccinated in the 2017-2018 season at the specially designated facilities within the Teaching Hospital.

Brief summary: Flu vaccination, as well as being effective to prevent seasonal influenza, decreases staff illness and absenteeism and reduces costs resulting from loss of productivity. Despite the effectiveness of flu vaccination, the seasonal coverage among healthcare workers is usually low. The aim of this retrospective observational study is to analyze the vaccination coverage rate among all employees (healthcare workers and administrative staff) of a large teaching hospital in Rome during the 2017-2018 influenza season, to perform a cost-consequence analysis of influenza vaccination (by evaluating the absenteeism due to illness in the epidemic period), and to assess the impact of vaccination in terms of both costs and sick days.


Eligibility criteria: Inclusion Criteria:

• Healthcare workers at Fondazione Policlinico Universitario "A.Gemelli" IRCCS

Exclusion Criteria:

• Healthcare workers not working at Fondazione Policlinico Universitario "A.Gemelli" IRCCS

Primary outcomes:
measure: Effectiveness of the quadrivalent vaccine
timeFrame: 33 weeks
measure: Economic impact of the quadrivalent vaccine
timeFrame: 33 weeks
Secondary outcomes:
measure: Expected economic savings for each one percentage point increase in vaccination coverage
timeFrame: 33 weeks
measure: Non-economic incentives for healthcare personnel who decide to vaccinate
timeFrame: 33 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario "A.Gemelli" IRCCS
Study officials:
References:
Clinical trial NCT02822638: Cohort of STEMI Patients
Official title: CoHort of STEMI Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
biomarkers
STEMI
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 1204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STEMI PATIENT

Brief summary: Ischemic heart disease is the leading cause of mortality in industrialized countries. ST elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely reperfusion (primary percutaneous intervention) and significant progression in pharmacologic intervention.

However, death and heart failure incidence after STEMI remain elevated: up to 20% at one year.

Also, therapeutic management following international guidelines is standardized toward a "one-size fits all" therapeutic management.

In order to continue improving myocardial infarction outcomes, there is a need to better understand and individualize therapeutic targets such myocardial reperfusion injury, post reperfusion inflammation, adverse left ventricular (LV) remodeling ....

This knowledge will allow us to propose new therapeutic strategies and in the long run strive towards personalized medicine.

The aim objective of this cohort of STEMI patients is to identify new biological markers of injury and prognosis.


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
* Primary PCI within 12 hours of symptoms onset.

Exclusion Criteria:

* Diagnosis of STEMI not confirmed by angiography
* Refusal to participate in the study or to sign the consent
* Inability to give information to the subject about the study
* Lack of medical social coverage
* Deprivation of civil rights

Primary outcomes:
measure: Change in Troponin
timeFrame: Day 0
measure: Change in Creatine Kinase
timeFrame: Day 0
Secondary outcomes:
measure: New York Heart Association (NYHA) Class
timeFrame: at admission (Day 0)
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 24 hours after PCI (Day 1)
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine
Study officials:
affiliation: Centre d'investigation Clinique , Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine - 69677 BRON
name: Michel OVIZE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01964638: Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.
Official title: Comparative Analysis of Software-based MRI-Ultrasound Image Fusion Against Cognitive Targeting of Multi-Parametric MRI Findings With Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Prostate Biopsy
Targeted Biopsy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 126
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas


Eligibility criteria: Inclusion Criteria:

* No previous diagnosis of adenocarcinoma of the prostate
* No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations)
* Active urinary tract infection

Exclusion Criteria:

* Prior pelvic radiotherapy
* Prior androgen deprivation therapy
* Evidence urinary tract infection or significant urinary retention
* Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI.
* Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)

Primary outcomes:
measure: Evaluation of rates of prostate cancer diagnosis
timeFrame: One week after biopsy
Secondary outcomes:
measure: Evaluation of Rate of cancer diagnosis using targeted biopsy
timeFrame: One week after biopsy
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Smilow Prostate Cancer Center
state: New York
Study officials:
affiliation: Co-Director, Smilow Comprehensive Prostate Cancer Center
name: Samr S Taneja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00572338: Therapeutic Research in Multiple Myeloma
Official title: UARK 91-004 Therapeutic Research in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 6388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Samples will be studied in the laboratory and in experimental animal models. These analyses and animal models may help to better understand multiple myeloma and to better select the appropriate treatment for all participants with multiple myeloma.

Brief summary: The purpose of this study is to learn how myeloma cells grow and become a cancer, how to distinguish them from normal cells and how to eliminate these cells selectively.

Detailed description: Participating in this study will require that blood and bone marrow samples be obtained as a part of the diagnostic work-up or follow-up of your multiple myeloma. Bone marrow/peripheral blood/tissue samples will be collected for research purposes, as well as testing for genetic traits of Castleman's disease if you consent to this study. In addition, data will be collected including demographic information gathered from your medical record, including gender, date of birth, ethnicity, date of diagnosis, laboratory and pathology results, treatment protocols, dates of relapses, subsequent treatment protocols, and current treatments and medications.

Eligibility criteria: Inclusion Criteria:

* Any subject evaluated for a MIRT protocol

Exclusion Criteria:

* Subjects who have not been evaluated for a MIRT protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences/MIRT
state: Arkansas
Study officials:
affiliation: UAMS Myeloma Institute for Research and Therapy
name: Bart Barlogie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02003638: Assessment Of Vascular Health After Niacin Therapy (AVANT)
Official title: A 12-WEEK STUDY EVALUATING THE EFFECTS OF NIACIN ON VASCULAR HEALTH ASSESSED BY FLUORODEOXYGLUCOSE-PET/CT AND CIRCULATING ENDOTHELIAL PROGENITOR CELLS AND MICROPARTICLES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Carotid Artery Disease
Peripheral Artery Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 9
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and favorably affect circulating levels of endothelial progenitor cells and microparticles in people with atherosclerotic disease on chronic statin therapy.


Eligibility criteria: Inclusion Criteria:

* Men age 55 years and above with coronary artery disease or women age 65 years and above with coronary artery disease OR Men age 45 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease or women age 55 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease.
* Subjects must be on statin monotherapy, defined as a stable statin dose for at least 12 weeks, with no anticipated need for further titration during the study period

Exclusion Criteria:

* Anxiety or claustrophobia prohibiting imaging
* History of allergy to intravenous contrast, iodine, or shellfish
* Renal insufficiency
* History of allergy or severe intolerance to niacin
* History of diabetes mellitus or elevated fasting glucose
* Moderate to severe gout
* Peptic ulcer disease
* Acute coronary syndrome, transient ischemic attack or cerebrovascular accident, or acute limb ischemia in the preceding 12 months
* Heart failure or unstable angina pectoris
* Use of daily non-statin lipid-altering therapy prior to the initiation of study medication

Primary outcomes:
measure: Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Emil deGoma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02927938: Leukemia Stem Cell Detection in Acute Myeloid Leukemia
Official title: Leukemia Stem Cell Detection in Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia (AML)
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following induction chemotherapy. However, a large majority subsequently relapse and succumb to the disease. Currently, cytogenetics and molecular aberrations are the best prognostic indicators; however, these factors cannot prognosticate accurately for individual patients. Overall, the majority of patients with favorable or intermediate-risk AML will experience relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably translate into cure. This study is undertaken to determine whether the presence of LSCs has prognostic value as well as to determine whether the presence of LSCs has predictive value. This study has an observational component, whereby we intent evaluate whether the presence or absence of LSCs is prognostic. This study also has an interventional component in which it uses LSC status to determine whether favorable and intermediate risk AML patients in CR receive consolidation with chemotherapy or allogeneic HCT.


Eligibility criteria: Inclusion Criteria:

1. Must have previously signed the specimen procurement protocol consent associated with the leukemia stem cell assay ("Step 1 informed consent") prior to starting AML therapy.
2. Age 18 years and older
3. New diagnosis of AML, other than APL, confirmed by bone marrow aspirate/biopsy and reviewed by an institutional hematopathologist
4. Completion of induction therapy, as defined by the Investigator and post-induction bone marrow biopsy.

Exclusion Criteria:

1. Any debilitating medical or psychiatric illness that would preclude ability to follow study procedures.
2. Indeterminate leukemia stem cell assay results at diagnosis.

Primary outcomes:
measure: 2 Year Relapse Free Survival (RFS)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Grunwald, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854438: Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes
Official title: Pharmacist-initiated Reduction of Anticholinergic Drug Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anticholinergic Side Effects
Keywords: anticholinergic drugs
adverse events
elderly
clinical pharmacist
Evaluate the clinical effects of reducing anticholinergic in elderly
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: Norwegian Directorate of Health
First posted: 2009-03-03
Enrollment: 87
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Thesis: Is drug-induced anticholinergic activity additive resulting in a total anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to reduce the anticholinergic load by multidisciplinary medical review including a pharmacist and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity, activity of daily living and neuropsychiatric symptoms.

Design: A randomized, controlled, single blinded interventional study in Norwegian nursing homes.

Detailed description: Several studies have claimed that drugs showing anticholinergic activity in vitro cause high levels of serum anticholinergic activity in vivo that might cause impaired cognitive and functional functions in elderly. Pathophysiological changes in Alzheimer's dementia makes these patients particularly vulnerable for anticholinergic cognitive impairments. The PRADA-study is the first interventional study evaluating the clinical effects of reducing drug-induced anticholinergic load in patients with dementia. This is also the first interventional study in the Nordic countries evaluating the clinical effects of clinical pharmacy.

Eligibility criteria: Inclusion Criteria:

* Long-term nursing home patients with none, mild or moderate dementia (evaluated by CDR9,using drugs with a total anticholinergic burden that might lead to adverse events.

Exclusion Criteria:

* Not able to perform the testes because of physical or psychiatric illnesses.

Primary outcomes:
measure: CERADS word list measuring immediately and delayed recall
timeFrame: 4 years
Secondary outcomes:
measure: Mouth dryness
timeFrame: 4 years
measure: ADL
timeFrame: 4 years
measure: Serum anticholinergic activity
timeFrame: 4 years
measure: CERADS word list recognition
timeFrame: 4 years
measure: MMSE
timeFrame: 4 years
measure: NPI
timeFrame: 4 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevaal University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Torgeir B. Wyller, Professor
role: STUDY_DIRECTOR
affiliation: Ullevaal University Hospital
name: Hege Kersten, MScPharm/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03433638: Juvenile Dermatomyositis
Official title: Retrospective Descriptive Study of Juvenile Dermatomyositis in Alsace
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Juvenile Dermatomyositis
Keywords: Juvenile dermatomyositis
Inflammatory myopathy
Clinical features
Treatment
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 22
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975

Brief summary: This is a retrospective descriptive cross-sectional and observational multicenter clinical and progressive study of juvenile dermatomyositis. The aim is to determine the clinical, paraclinical, and evolutive characteristics and therapeutic modalities from a series of juvenile dermatomyositis identified in Alsace between 2000 to 2015.


Eligibility criteria: Inclusion Criteria:

* Age under 16 years
* Have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Study of clinical characteristics of juvenile dermatomyositis
timeFrame: The period from from January 1st, 2000 to December 31st, 2015 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Dermatologie
Study officials:
References:
Clinical trial NCT02548338: Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer
Official title: Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are selecting sixty (60) with breast cancer diagnoses where the surgical treatment is indicated.Furthermore the investigators divided in two groups : 1) surgical treatment using regular electric scalpel ; 2) surgical treatment using argon plasma coagulation scalpel. Our primary goal is to measure the bleeding during the surgery using the weight of the surgical tissues used. Secondary we'll evaluate the immediate post operative outcomes, like infection, hematomas and seromas. All these variables will be evaluated by a doctor using our standard clinical record and it will be measured using reliable parameters, for exemple: if the investigators clinically detect a hematoma then we'll perform an ultrasound to take the real extension; if the investigators clinically pick an infection we'll measure the extension of the hiperemia; and if the investigators clinically pick a seroma we'll drain and quantify it. Secondary the investigators going to evaluate and measure (centimeters) the terminal damage caused on the surgical specimens (samples) using the microscope.


Eligibility criteria: Inclusion Criteria:

* operable breast cancer

Exclusion Criteria:

* coagulation disturbs

Primary outcomes:
measure: intra-operative outcomes
timeFrame: surgery duration
measure: post operative outcomes
timeFrame: 30 days
Secondary outcomes:
measure: margin damage
timeFrame: during the surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00836108: Unsupported Arm Exercise and Breathing Strategy in Patients With Chronic Obstructive Pulmonary Disease
Official title: Unsupported Arm Exercise and Breathing Strategy in Patients With Chronic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Lung Diseases, Obstructive
Breathing Exercises
Exercise Tolerance
Dyspnea
Arm Exercise
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Controlling the way people with lung problems breathe during arm exercises may reduce their breathlessness during activities of daily living that require them to lift their arms (i.e. brushing their hair, putting groceries away on high shelves). The main aim of this study is to determine the effects of specific breathing strategies during arm exercise on dyspnoea in patients with chronic lung disease. Coordinating inspiration with the action of arm elevation will reduce dyspnoea during a rhythmic overhead arm activity


Eligibility criteria: Inclusion Criteria:

* diagnosis of COPD including forced expiratory volume in one second \< 80% predicted normal
* presence of lung hyperinflation at rest

Exclusion Criteria:

* musculoskeletal or neurological condition which could adversely affect arm activity

Primary outcomes:
measure: Dyspnoea during arm exercise
timeFrame: 1 week
Secondary outcomes:
measure: Arm exercise endurance
timeFrame: 1 week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Dina Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dolmage TE, Janaudis-Ferreira T, Hill K, Price S, Brooks D, Goldstein RS. Arm elevation and coordinated breathing strategies in patients with COPD. Chest. 2013 Jul;144(1):128-135. doi: 10.1378/chest.12-2467.