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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01431326




Registration number
NCT01431326
Ethics application status
Date submitted
17/08/2011
Date registered
9/09/2011

Titles & IDs
Public title
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Scientific title
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Secondary ID [1] 0 0
IND 113645
Secondary ID [2] 0 0
Pro00029638
Universal Trial Number (UTN)
Trial acronym
PTN_POPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenovirus 0 0
Anesthesia 0 0
Anxiety 0 0
Anxiolysis 0 0
Autism 0 0
Autistic Disorder 0 0
Bacterial Meningitis 0 0
Bacterial Septicemia 0 0
Benzodiazepine 0 0
Bipolar Disorder 0 0
Bone and Joint Infections 0 0
Central Nervous System Infections 0 0
Convulsions 0 0
Cytomegalovirus Retinitis 0 0
Early-onset Schizophrenia Spectrum Disorders 0 0
Epilepsy 0 0
General Anesthesia 0 0
Gynecologic Infections 0 0
Herpes Simplex Virus 0 0
Infantile Hemangioma 0 0
Infection 0 0
Inflammation 0 0
Inflammatory Conditions 0 0
Intra-abdominal Infections 0 0
Lower Respiratory Tract Infections 0 0
Migraines 0 0
Pain 0 0
Pneumonia 0 0
Schizophrenia 0 0
Sedation 0 0
Seizures 0 0
Skeletal Muscle Spasms 0 0
Skin and Skin-structure Infections 0 0
Treatment-resistant Schizophrenia 0 0
Urinary Tract Infections 0 0
Withdrawal 0 0
Sepsis 0 0
Gram-negative Infection 0 0
Bradycardia 0 0
Cardiac Arrest 0 0
Cardiac Arrhythmia 0 0
Staphylococcal Infections 0 0
Nosocomial Pneumonia 0 0
Neuromuscular Blockade 0 0
Methicillin Resistant Staphylococcus Aureus 0 0
Endocarditis 0 0
Neutropenia 0 0
Headache 0 0
Fibrinolytic Bleeding 0 0
Pulmonary Arterial Hypertension 0 0
CMV Retinitis 0 0
Hypertension 0 0
Chronic Kidney Diseases 0 0
Hyperaldosteronism 0 0
Hypokalemia 0 0
Heart Failure 0 0
Hemophilia 0 0
Heavy Menstrual Bleeding 0 0
Insomnia 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Skin 0 0 0 0
Other skin conditions
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Epilepsy
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Autistic spectrum disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of pharmacokinetic outcomes for understudied drugs in children
Timepoint [1] 0 0
Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary outcome [1] 0 0
Composite pharmacodynamic outcomes of understudied drugs in children
Timepoint [1] 0 0
Data will be collected throughout the hospital or outpatient stay up to 90 days
Secondary outcome [2] 0 0
Biomarkers associated with understudied drugs in children
Timepoint [2] 0 0
Data will be collected throughout the hospital or outpatient stay up to 90 days

Eligibility
Key inclusion criteria
* 1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 1) Failure to obtain consent/assent (as indicated)
* 2) Known pregnancy as determined via interview or testing if available.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
Accrual to date
Final
3520
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Merewether
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Keswick
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Box Hill
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fremantle
Recruitment hospital [5] 0 0
Peninsula Health Mental Health Services - Frankston
Recruitment hospital [6] 0 0
Neurotherapy Victoria - Malvern
Recruitment hospital [7] 0 0
The Alfred, Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment hospital [8] 0 0
The Melbourne Clinic - Richmond
Recruitment hospital [9] 0 0
Lyell McEwin Hospital, Mental Health Clinical Trials Unit - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2291 - Merewether
Recruitment postcode(s) [2] 0 0
5035 - Keswick
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3121 - Richmond
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Oregon
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
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Arkansas
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California
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United States of America
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Hawaii
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
Country [17] 0 0
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Michigan
Country [18] 0 0
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Mississippi
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Missouri
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Montana
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Nebraska
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New Hampshire
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New Mexico
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North Carolina
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Ohio
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Utah
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Vermont
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Ontario
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Israel
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Tel Aviv
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Petah Tikva
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Singapore
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Singapore
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United Kingdom
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Hampshire
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Merseyside
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Pennsylvania
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Rio De Janeiro
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Oulu
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Seinajoki
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Dresden
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Friedrichsthal
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Furth Im Wald
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Goch
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Hamburg
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Ludwigshafen
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Münster
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Saarbrücken
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Schweinfurt
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Sulzbach
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Greece
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Ampelokipoi
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Greece
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Athens
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Mako
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Salgotarjan
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Sopron
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Beer Sheva
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Haifa
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Raanana
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Carpi
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Castellanza
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Foggia
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Forli
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Sesto San Giovanni
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Utena
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Auckland
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Kamieniec Zabkowicki
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Szczecin
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Tychy
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Warsaw
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Puerto Rico
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Hato Rey
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Puerto Rico
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Manati
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Puerto Rico
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San Juan
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Romania
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Bucharest
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Cluj-Napoca
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Iasi
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Oradea
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Ploiesti
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Romania
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Resita
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Romania
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Targu-Mures
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Russian Federation
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Paarl
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Parow
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Alicante
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Cordoba
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Spain
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Pozuelo De Alarcon
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Requena
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Spain
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Seville
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Spain
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Toledo
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Turkey
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Gaziantep
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Turkey
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Hatay
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Turkey
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Izmir
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Turkey
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Kayseri
Country [131] 0 0
United Kingdom
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Berks
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United Kingdom
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Leicestershire
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Surrey
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United Kingdom
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Wales
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Argentina
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Cordoba
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Chile
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Il Region
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Chile
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Santiago
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Warrington Cheshire
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Derby
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Horsham
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Newcastle upon Tyne
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Other
Name
Daniel Benjamin
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
The Emmes Company, LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chi Hornik, PharmD
Address 0 0
Duke University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Completed study datasets (limited PHI) may be requested from https://pediatrictrials.org/data-sharing-opportunities Study data may be posted to the NICHD Data and Specimen Hub (DASH)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Tremoulet A, Le J, Poindexter B, Sullivan JE, Laug... [More Details]
Journal Gonzalez D, Melloni C, Yogev R, Poindexter BB, Men... [More Details]
Journal Gonzalez D, Melloni C, Poindexter BB, Yogev R, Atz... [More Details]
Journal Hornik CP, Benjamin DK Jr, Smith PB, Pencina MJ, T... [More Details]
Journal Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poinde... [More Details]
Journal Autmizguine J, Melloni C, Hornik CP, Dallefeld S, ... [More Details]
Journal Le J, Poindexter B, Sullivan JE, Laughon M, Delmor... [More Details]
Journal Dallefeld SH, Atz AM, Yogev R, Sullivan JE, Al-Uzr... [More Details]
Journal Hornik CP, Gonzalez D, van den Anker J, Atz AM, Yo... [More Details]
Journal Drolet BA, Boakye-Agyeman F, Harper B, Holland K, ... [More Details]
Journal Hornik CP, Yogev R, Mourani PM, Watt KM, Sullivan ... [More Details]
Journal Maharaj AR, Gonzalez D, Cohen-Wolkowiez M, Hornik ... [More Details]
Journal Maharaj AR, Wu H, Zimmerman KO, Speicher DG, Sulli... [More Details]
Journal Thompson EJ, Wu H, Melloni C, Balevic S, Sullivan ... [More Details]
Journal Ge S, Mendley SR, Gerhart JG, Melloni C, Hornik CP... [More Details]
Journal Maharaj AR, Wu H, Zimmerman KO, Autmizguine J, Kal... [More Details]
Journal Commander SJ, Wu H, Boakye-Agyeman F, Melloni C, H... [More Details]
Journal Wu YSS, Cohen-Wolkowiez M, Hornik CP, Gerhart JG, ... [More Details]
Journal Maharaj AR, Wu H, Zimmerman KO, Muller WJ, Sulliva... [More Details]
Journal Gerhart JG, Carreno FO, Ford JL, Edginton AN, Perr... [More Details]
Journal Karatza E, Ganguly S, Hornik CD, Muller WJ, Al-Uzr... [More Details]
Journal Smith MJ, Gonzalez D, Goldman JL, Yogev R, Sulliva... [More Details]
Journal Richards C, Iosifescu DV, Mago R, Sarkis E, Reynol... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT01431326