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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 December 2018
Main ID:  ChiCTR1800019958
Date of registration: 2018-12-09
Prospective Registration: Yes
Primary sponsor: Daping Hospital, Army Medical University (Third Military Medical University)
Public title: Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease
Scientific title: Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease
Date of first enrolment: 2018-12-16
Target sample size: Case series:60;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=33693
Study type:  Observational study
Study design:  Case series  
Phase:  New Treatment Measure Clinical Study
Countries of recruitment
China
Contacts
Name: YANG YANG   
Address:  10 Changjiang Branch Road, Yuzhong District, Chongqing, China
Telephone: +86 18202388902
Email: yyang_tmmu@163.com
Affiliation:  Daping Hospital, Army Medical University (Third Military Medical University)
Name: YANG YANG   
Address:  10 Changjiang Branch Road, Yuzhong District, Chongqing, China
Telephone: +86 18202388902
Email: yyang_tmmu@163.com
Affiliation:  Daping Hospital, Army Medical University (Third Military Medical University)
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients diagnosed as CD based on the established criteria;and Patients willing to accept infliximab treatment;
2. Patients diagnosed as Perianal CD were confirmed by pelvic floor MRI

Exclusion criteria: 1. Patients diagnosed as pulmonary diseases, acute and chronic infectious diseases, heart diseases, ear and nose diseases or claustrophobia;
2. Acute abdomen or Intestinal obstruction or superior position intestinal fistula;
3. Allergic or intolerance to infliximab treatment or Hyperbaric Oxygen Therapy;
4. Patients with liver and kidney dysfunction: TBIL> 1.5 ULN, ALT or AST> 2.0 ULN, Cr> 1.5 ULN.


Age minimum: 18
Age maximum: 65
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Case series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy;
Primary Outcome(s)
remission rate;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status: Not approved
Approval date: 26/08/2013
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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