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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000042191
受付番号 R000048159
科学的試験名
一般公開日(本登録希望日) 2021/05/01
最終更新日 2020/10/21

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Does going to the Orthopaedic outpatient clinic in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia
一般向け試験名略称/Acronym
Does going to the Orthopaedic outpatient clinic in the pandemic era increase the risk of developing COVID-19?
科学的試験名/Scientific Title
Does going to the Orthopaedic outpatient clinic in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia
科学的試験名略称/Scientific Title:Acronym
Does going to the Orthopaedic outpatient clinic in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Subjects were patients who went to the Orthopaedic outpatient clinic of our institution from April to May 2020. Those who were previously infected with COVID-19 from polymerase chain reaction (PCR) reverse transcriptase (RT) examination obtained via nasopharynx and oropharynx swab, as well as those who had fever were excluded from the study.
疾患区分1/Classification by specialty
整形外科学/Orthopedics 成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
This study aims to investigate the association between going to the Orthopaedic outpatient clinic and the risk of developing COVID-19.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
Prognosis, Risk Ratio
試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Variables analysed in this study includes age, gender, marital status, clinical symptoms, smoking status, comorbidities, any history of visitation to pandemic countries, and any frequent contact with COVID-19-positive patients. These variables are considered risk factors that may contribute to the development of COVID-19 infection.
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 観察/Observational

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
7 ヶ月/months-old 以上/<=
年齢(上限)/Age-upper limit
74 歳/years-old 未満/>
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Subjects were patients who went to the Orthopaedic outpatient clinic of our institution from April to May 2020.
除外基準/Key exclusion criteria
Those who were previously infected with COVID-19 from polymerase chain reaction (PCR) reverse transcriptase (RT) examination obtained via nasopharynx and oropharynx swab, as well as those who had fever were excluded from the study
目標参加者数/Target sample size 54

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Achmad
ミドルネーム Fauzi
Kamal
所属組織/Organization
Department of Orthopaedics and Traumatology, Faculty of Medicine Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
所属部署/Division name
Musculoskeletal Oncology and Reconstructive Division
郵便番号/Zip code 10430
住所/Address
Jl. Diponegoro no. 71, Jakarta 10430 Indonesia
電話/TEL +6281511450189
Email/Email fauzikamal@yahoo.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

I Wayan Arya Mahendra
ミドルネーム
Karda
組織名/Organization
Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
部署名/Division name
Department of Orthopaedics and Traumatology
郵便番号/Zip code 10430
住所/Address
Jl. Diponegoro no. 71, Jakarta 10430 Indonesia
電話/TEL 6287788408163
試験のホームページURL/Homepage URL
Email/Email arya961mahendra@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Universitas Indonesia
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Universitas Indonesia
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
住所/Address
Gedung Fakultas Kedokteran UI JI. Salemba Raya No.6, Jakarta 10430 PO.Box 1358
電話/Tel +62213912477
Email/Email humas@fk.ui.ac.id

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2021 05 01

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled 54
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2020 05 01
倫理委員会による承認日/Date of IRB
2020 05 18
登録・組入れ開始(予定)日/Anticipated trial start date
2020 05 20
フォロー終了(予定)日/Last follow-up date
2020 08 01
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information
This was a combined retrospective and prospective study and performed at the Orthopaedic outpatient clinic at a national tertiary hospital in Jakarta, Indonesia. Variables analysed including age, gender, marital status, clinical symptoms, smoking status, comorbidities, and any history of visitation to pandemic countries and any frequent contact with COVID-19-positive patients. Physical examination, laboratory testing and plain x-ray of the thorax were done to evaluate the outcome.

管理情報/Management information
登録日時/Registered date
2020 10 21
最終更新日/Last modified on
2020 10 21


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048159
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048159

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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