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Trial registered on ANZCTR
Registration number
ACTRN12616001540404
Ethics application status
Approved
Date submitted
11/10/2016
Date registered
8/11/2016
Date last updated
30/01/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Clinical importance of biomarkers in the management and to predict survival of critically ill patients after resuscitation from cardiac arrest in Emergency Departament.
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Scientific title
Neuron-specific enolase, S100B and Resistin - Clinical importance of biomarkers in the management and to predict survival of critically ill patients after resuscitation from cardiac arrest in Emergency Departament.
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Secondary ID [1]
290307
0
none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cardiac arrest
300562
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Condition category
Condition code
Cardiovascular
300419
300419
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
30
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Target follow-up type
Days
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Description of intervention(s) / exposure
In this study we try to identify the role of biomarkers: Neuron specific enolase (NSE), S-100B protein, resistin in the management of critically ill patients and to predict survival after resuscitation from cardiac arrest within 30 days.
The biomarkers seric level will be determinate at time 0 (T0- the moment of the admission in ED- Emergency Department) , and T6, T12, T24, T48 and T72 hours from the admission, using the ELISA technique. For each biomarker we will strictly follow the producer instruction for sampling blood, determination and conservation. The results of these biomarkers determined by the patients admitted in the study (who meet the inclusion criteria) will be compared with values obtained from 40 healthy volunteers interpreted as normal reference values.
Correlation between the level of biomarkers with Sequential Organ Failure Assessment (SOFA) and Cerebral Performance Category (CPC) to establish the outcome of survival after resuscitation from cardiac arrest patients. The SOFA score will be calculate at the moment of admission in the study and at 24, 48, 72 hours. The CPC score will calculate at the moment of admission in the study and at 24, 48, 72 hours and to hospital discharge, at 30 days or at the moment of recording the death (if death occurred until the end of the 30 days of monitoring). And we will also note date when the death occurred.
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Intervention code [1]
296118
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
299861
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The correlation between serum levels of resistin, with severity of organ dysfunction assessed by SOFA to predict survival prognosis (survival to 30 days) in patients with cardiorespiratory arrest (CRA).
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Assessment method [1]
299861
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Timepoint [1]
299861
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Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
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Primary outcome [2]
299985
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The correlation between serum levels of enolase specific neuron with severity of neuronal dysfunction assessed by CPC to predict neurological outcome (at 30 days) in patients with cardiorespiratory arrest (CRA).
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Assessment method [2]
299985
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Timepoint [2]
299985
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Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
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Primary outcome [3]
299986
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The correlation between serum levels of protein S100B with severity of neuronal dysfunction assessed by CPC to predict neurological outcome (at 30 days) in patients with cardiorespiratory arrest (CRA).
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Assessment method [3]
299986
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Timepoint [3]
299986
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Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
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Secondary outcome [1]
328330
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The correlation between serum levels of resistin to determin cutoff values that predict survival after CRA assessed by values obtained with statistical methods
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Assessment method [1]
328330
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Timepoint [1]
328330
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Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
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Secondary outcome [2]
328583
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The correlation between serum levels of resistin and pathology that led to the occurrence of the CRA assessed by review of medical records.
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Assessment method [2]
328583
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Timepoint [2]
328583
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Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
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Secondary outcome [3]
328584
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The correlation between serum levels of resistin and duration of resuscitation until they get ROSC (return of spontaneous circulation) assessed through review of medical records.
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Assessment method [3]
328584
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Timepoint [3]
328584
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Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
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Secondary outcome [4]
328762
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The correlation between serum levels of enolase specific neuron to determin cutoff values that predict poor neurological outcomes assessed by values obtained with statistical methods.
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Assessment method [4]
328762
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Timepoint [4]
328762
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Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
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Secondary outcome [5]
328763
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The correlation between serum levels of protein S100B to determin cutoff values that predict poor neurological outcomes assessed by values obtained with statistical methods.
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Assessment method [5]
328763
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Timepoint [5]
328763
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Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
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Eligibility
Key inclusion criteria
- age over 18 and under 85 years
- cardiac arrest with ROSC (return of spontaneous circulation)
- GCS (coma Glasgow score) >/=3
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- age under 18 and over 85 years
- pregnant women
- sever brain trauma, politrauma, major burns
- cardiac arrest secondary to acute bleeding
- cardiac arrest without ROSC in the first 6 hours after admission
- cardiac arrest secondary to hypothermia
- terminal neoplasia
- patients in detention
- patients with informed consent not obtained
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Statistical analysis of data will be done with parametric and nonparametric tests depending on the parameter analyzed data and the distribution on the study group. If needed, be applied a specific correction type to serial determinations for multiple values.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/12/2016
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Actual
12/01/2017
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Date of last participant enrolment
Anticipated
1/12/2017
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Actual
8/10/2017
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Date of last data collection
Anticipated
4/12/2017
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Actual
8/11/2017
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment outside Australia
Country [1]
8305
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Romania
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State/province [1]
8305
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Cluj county, Cluj-Napoca city
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Funding & Sponsors
Funding source category [1]
294689
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University
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Name [1]
294689
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Iuliu Hatieganu UMF Cluj-Napoca, Romania
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Address [1]
294689
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Victor Babes street, no.8, Cluj-Napoca City, Cluj county, postal code 400012, Romania
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Country [1]
294689
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Romania
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Primary sponsor type
University
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Name
Iuliu Hatieganu UMF Cluj-Napoca, Romania
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Address
Victor Babes street, no.8, Cluj-Napoca City, Cluj county, postal code 400012, Romania
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Country
Romania
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Secondary sponsor category [1]
293533
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None
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Name [1]
293533
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Address [1]
293533
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Country [1]
293533
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296114
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Ethics Committee of Scientific Research - UMF Cluj-Napoca, Romania
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Ethics committee address [1]
296114
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Louis Pasteur street, no. 4-6, Cluj-Napoca city, Cluj county, postal code 400349, Romania
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Ethics committee country [1]
296114
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Romania
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Date submitted for ethics approval [1]
296114
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17/02/2016
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Approval date [1]
296114
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14/03/2016
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Ethics approval number [1]
296114
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59
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Summary
Brief summary
Cardio-respiratory arrest (CRA) remains a major health problem with great implications for the emotional and financial impact of the patient, the family and society. The management of cardiac arrest patients represents an ongoing challenge to clinicians in order to reduce mortality and restore patient functionality with minimal disability. Current research in medicine have the foreground of identifying biomarkers useful in assessing the diagnosis, risk stratification, therapy and prognosis of cardiac arrest patients admitted in the emergency department. The study aimed to determine the role of biomarkers – NSE, protein S-100B and resistin - along with clinical data to assess early prognosis (survival at 30 days of admission to study) and the opportunity to further develop the protocols management of the diagnosis and treatment of patients resuscitated after CRA depending on the level of these markers. Our primary objective is to determine the correlation between serum levels of resistin, NSE and protein S100B (dosed at predetermined time intervals) and the severity of organ dysfunction, to predict survival prognosis and neurological outcome in patients with CRA. Our secondary objectives are: - the correlation between serum levels of resistin and duration of resuscitation until they get ROSC (return of spontaneous circulation) assessed through review of medical records. - the correlation between the serum levels of resistin and the pathology that led to the occurrence of the CRA. - determining cutoff values that predict poor outcomes and determin survival correlated with the serum levels of biomarkers studied. Observational study, prospective, single-center, will include CRA resuscitated patients admitted to ED with enrolled inclusion and exclusion criteria very well established. All patients will receive customary blood sampling and biological samples that characterize the specific pathology/comorbidities in each case, the radiology and imagistic medical case management needed. Determinations will be done for each biomarker in preestablish time intervals set in the study protocol and following manufacturers indications of sampling and storage. It will mark the benchmarks of the results obtained in the study. Monitoring data will be done after severity scores SOFA, CPC, serum levels of sampling biomarkers studied and after patient survival duration. Statistical analysis will be performed according to rigors established from information resulting from demographic data, levels of serum markers and parameters evaluated in the study. With this study we hope to bring more informations to the current research, identifying the role of biomarkers and correlating the levels with the survival, identifying the biomarkers with high specificity and sensitivity to predict survival in critically ill patients after resuscitation from cardiac arrest in ED and setting up the future protocols for management in resuscitated patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
69598
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Dr Raluca - Mihaela Tat
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Address
69598
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Emergency County Hospital Cluj-Napoca, Clinicilor street, no. 3-5, Cluj-Napoca City, Cluj County, Romania, 400006
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Country
69598
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Romania
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Phone
69598
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+ 40026431876
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Fax
69598
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Email
69598
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[email protected]
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Contact person for public queries
Name
69599
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Raluca - Mihaela Tat
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Address
69599
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Emergency County Hospital Cluj-Napoca, Clinicilor street, no. 3-5, Cluj-Napoca City, Cluj County, Romania, 400006
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Country
69599
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Romania
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Phone
69599
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+ 40026431876
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Fax
69599
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Email
69599
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[email protected]
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Contact person for scientific queries
Name
69600
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Raluca - Mihaela Tat
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Address
69600
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Emergency County Hospital Cluj-Napoca, Clinicilor street, no. 3-5, Cluj-Napoca City, Cluj County, Romania, 400006
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Country
69600
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Romania
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Phone
69600
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+ 40026431876
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Fax
69600
0
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Email
69600
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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