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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000014120 |
Receipt No. | R000016407 |
Scientific Title | Prospective observational study for psychiatric symptoms of pediatric Basedow's disease |
Date of disclosure of the study information | 2014/06/01 |
Last modified on | 2017/06/02 |
Basic information | ||
Public title | Prospective observational study for psychiatric symptoms of pediatric Basedow's disease | |
Acronym | Prospective observational study for psychiatric symptoms of pediatric Basedow's disease | |
Scientific Title | Prospective observational study for psychiatric symptoms of pediatric Basedow's disease | |
Scientific Title:Acronym | Prospective observational study for psychiatric symptoms of pediatric Basedow's disease | |
Region |
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Condition | |||||
Condition | Basedow's disease | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To observe clinical characteristics, severity, and improvement course of psychiatric symptoms in Basedow's disease |
Basic objectives2 | Others |
Basic objectives -Others | To study the needs and methods of psychiatric therapy for cases that show psychiatric symptoms |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Description by a child psychiatrist and psychological examination about the course of behavior and emotional and social problems in clinical and borderline cases as assessed by the child behavior checklist (CBCL) and youth self-report (YSR) at the initial visit |
Key secondary outcomes | 1) point of improvement of psychiatric symptoms
2) point of improvement of GAF 3) frequency of clinical and borderline cases as assessed by CBCL and YSR |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Likely Basedow's disease according to the diagnostic guideline of thyroid disease
2)Patients were aged 4–16 years at the time of initial visit 3)Untreated Basedow's disease |
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Key exclusion criteria | 1)Past medical history of Basedow's disease or chronic thyroiditis
2)To find a case unsuitable by a doctor |
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Target sample size | 6 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokyo Metropolitan Children's Medical Center | ||||||
Division name | Division of Psychology and Welfare | ||||||
Zip code | |||||||
Address | 2-8-29 Musashidai Fuchu-shi Tokyo | ||||||
TEL | 042-300-5111 | ||||||
rie_kuge@tmhp.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokyo Metropolitan Children's Medical Center | ||||||
Division name | Division of Psychology and Welfare | ||||||
Zip code | |||||||
Address | 2-8-29 Musashidai Fuchu-shi Tokyo | ||||||
TEL | 042-300-5111 | ||||||
Homepage URL | |||||||
rie_kuge@tmhp.jp |
Sponsor | |
Institute | Tokyo Metropolitan Children's Medical Center |
Institute | |
Department |
Funding Source | |
Organization | none |
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 | |
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 | 東京都立小児総合医療センター |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | clinical characteristics, severity, and improvement course of psychiatric symptoms in Basedow's disease |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016407 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |