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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033632
Receipt No. R000038346
Scientific Title Study of evaluation of neurocognitive function and psycho-social problem in HIV-infected hemophilia
Date of disclosure of the study information 2018/09/01
Last modified on 2019/08/05

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Basic information
Public title Study of evaluation of neurocognitive function and psycho-social problem in HIV-infected hemophilia
Acronym Study of dimentia & mental health in HIV-infected hemophilia
Scientific Title Study of evaluation of neurocognitive function and psycho-social problem in HIV-infected hemophilia
Scientific Title:Acronym Study of dimentia & mental health in HIV-infected hemophilia
Region
Japan

Condition
Condition Hemophilia, HIV infection, neurocognitive disorder
Classification by specialty
Hematology and clinical oncology Neurology Infectious disease
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An evaluation of the prevalence and severity of neurocognitive disorder in HIV-infected hemophilia
Basic objectives2 Others
Basic objectives -Others Neuropsychological evaluation in HIV-infected hemophilia and compairisons with data of patients sexually transmitted HIV
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The prevalence and severity of neurocognitive disorder in HIV-infected hemophilia
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)HIV-infected hemophilia, (2)Older than 20 years old, (3)Written informed consent
Key exclusion criteria (1)Active AIDS-defining disease
(2)Congenital developmental retardation
(3)Definitive diagnosis of following diseases
a. Mental disorder: major depressive disorder, schizophrenia
b. Alzheimer's disease, Frontotemporallobar degeneration, Lewy-body disease, Vascular disease, Traumatic brain injury, Prion disease, Parkinson's disease, Huntington's disease
c. Another functional neurocognitive disorder
d. Illegal substance use
e. Severe alcoholism
f. Endocrine disorder: hypothyroidism, Wernicke encephalopathy, Vitamin B12 deficiency
g. Current treatment or sever sequelae of CNS opportunistic infections
h. Symptoms of a current, active infection a body temperature of >38.5 at the time of recruitment
(4)Experience of neuropsychiatric test within past 1 year
(5)Other inappropriate condition for neuropsychiatric test
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Endo
Organization Hokkaido University Hospital
Division name Department of blood
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo, 060-8648, Japan
TEL 011-706-7025
Email t-endo@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Ishida
Organization Hokkaido University Hospital
Division name HIV infection Medical Support Center
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo, 060-8648, Japan
TEL 011-706-7025
Homepage URL
Email issi3@huhp.hokudai.ac.jp

Sponsor
Institute HIV infection Medical Support Center, Hokkaido University Hospital
Institute
Department

Funding Source
Organization HIV infection Medical Support Center, Hokkaido University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 26 Day
Date of IRB
2018 Year 11 Month 30 Day
Anticipated trial start date
2018 Year 11 Month 30 Day
Last follow-up date
2019 Year 12 Month 30 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information Neuropsycgiatric examination

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038346

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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