№ files_lp_4_process_2_70525
File format: docx
Character count: 3301
File size: 23 KB
Year:
2026
Study Type:
Clinical trial
Phase:
Phase 2
Intervention:
Tesnatilimab, Ustekinumab, Placebo
Primary Endpoint:
Change from baseline in CDAI score at Weeks 8 and 12
Secondary Endpoints:
Clinical remission, clinical response, PRO-2 score, SES-CD, GHAS
Analysis Methods:
ANCOVA, MMRM, Cochran-Mantel-Haenszel chi-square test, Multiple Comparison Procedures
Sample Size:
60 patients per arm (Week 8), 50 patients per arm (Week 12)
Power:
84% (Week 8), 85% (Week 12)
Error Rate:
0.05 (two-sided)
Covariates:
Baseline CDAI score, SNP-positive status, Bio-IR status, study visit, visit-by-treatment interaction
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
Not specified
Region / City:
Not specified
Topic:
Infliximab dose escalation in Crohn’s disease treatment
Document type:
Medical request letter
Institution / Organization:
Not specified
Author:
Not specified
Target audience:
Insurance company
Period of validity:
Not specified
Approval date:
Not specified
Date of modifications:
Not specified
Year:
[Insert Year]
Region / City:
[Insert City, State ZIP]
Topic:
Medical treatment authorization
Document type:
Request letter
Organization / Institution:
[Insert Organization Name]
Target audience:
Medical Director, Payer (Insurance Company)
Period of validity:
[Insert Start Date] - [Insert End Date]
Approval date:
[Insert Date of Approval]
Amendment date:
[Insert Date of Changes if any]
Year:
2026
Region / city:
Multiple centers
Topic:
Medical research, Crohn’s disease
Document type:
Research study
Organization / institution:
Various medical institutions
Author:
Not specified
Target audience:
Medical professionals, researchers
Period of validity:
N/A
Approval date:
N/A
Modification date:
N/A
Year:
2024
Region / city:
Tangier, Morocco
Topic:
Inflammatory Bowel Disease, Crohn’s Disease
Document Type:
Research Study
Organization / Institution:
Mohamed VI University Hospital, Hepato-Gastroenterology Department
Authors:
K. Attaqi, F.Z. Bouamama, S. Temsamani, A. Akjay, H. Ouaya, H. Meyiz, I. Mellouki
Target Audience:
Medical professionals, gastroenterologists
Period of Action:
2020-2024
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / City:
Not specified
Document type:
Medical Case Report
Organization / Institution:
Not specified
Author:
Nicole Wiebe, Liena Zhao, Jessica P. Woolfson
Target audience:
Healthcare professionals, pediatric gastroenterologists
Period of action:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2022
Country:
United States
Study name:
Study of a Prospective Adult Research Cohort with IBD (SPARC IBD)
Affiliated organization:
Crohn’s & Colitis Foundation
Study type:
Prospective cohort study
Number of centers:
17
Population:
Adult patients with Crohn’s disease initiating vedolizumab or ustekinumab after anti-TNF therapy
Exposures:
Ustekinumab, Vedolizumab, Anti-TNF inhibitors
Outcomes:
Treatment discontinuation, Crohn’s disease–related surgery, malignancy, cardiac events, thromboembolic events
Data sources:
Commercial claims data, SPARC IBD cohort data
Coding systems:
ICD-10-CM, ICD-10-PCS, HCPCS Level I and II, CPT-4, NDC
Sample size (SPARC IBD subset):
Vedolizumab n=77; Ustekinumab n=227
Primary measures:
Incidence rates per 1000 person-years, hazard ratios with 95% confidence intervals
Citation:
Raffals LE, Saha S, Bewtra M, et al. Inflamm Bowel Dis 2022;28:192–199
Year:
2017
Region:
International (studies from Europe, Australasia, North America)
Topic:
Paediatric Crohn’s disease, nutrition therapy
Document type:
Review article
Institution:
Southampton Children’s Hospital, University of Southampton
Authors:
James J Ashton, Joan Gavin, R Mark Beattie
Keywords:
Crohn’s disease, nutrition, paediatric, exclusive enteral nutrition
Population:
Children and selected adult patients with Crohn’s disease
Study period:
1980–2017
Evidence sources:
Randomised controlled trials, observational studies, retrospective studies, meta-analyses, review articles, editorials, conference abstracts, case reports
Main focus:
Induction of remission, immune modulation, microbiome changes, growth and nutritional outcomes
Guideline references:
ECCO, ESPGHAN, NASPGHAN, ESPEN
Year:
2011
Region / city:
EU
Topic:
Efficacy data and information in plant protection product registration
Document type:
Technical Guidance Paper
Institution:
ECPA
Author:
ECPA
Target audience:
Applicants in plant protection product registration
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Contextual description:
A technical guidance paper outlining the preparation of concise efficacy summaries for plant protection product registration in the EU regulatory zone.
Year:
2023
Region / City:
Northern Ireland, UK; Sfax, Tunisia
Theme:
Antimicrobial agents, Biosurfactants, Oral hygiene
Document Type:
Research article
Institution:
Ulster University, University of Sfax
Author:
Mohamed Elshikh, Scott Funston, Alif Chebbi, Syed Ahmed, Roger Marchant, Ibrahim M. Banat
Target Audience:
Researchers, Biomedical professionals
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2017
Region / city:
Moscow
Subject:
Medical products, Registration, Electronic documents
Document type:
Board Decision
Institution:
Eurasian Economic Commission
Author:
Eurasian Economic Commission Board
Target audience:
Business entities, Authorized authorities of the Member States
Period of validity:
Indefinite
Approval date:
June 30, 2017
Date of amendments:
Not specified
Year:
2026
Region / City:
United States
Topic:
Urgency urinary incontinence treatment
Document Type:
Clinical trial report
Institution:
Multiple U.S. medical centers
Authors:
Alexandra Rogers, MD; Rebecca McCrery, MD; Scott MacDiarmid, MD; Subhro Sen, MD; James Lukban, DO; Bilal Kaaki, MD; Andrew Shapiro, MD; Thomas Giudice, MD; John Nguyen, MD; Joseph Gauta, MD; Scott Serels, MD; Chris Threatt, MD; Jed Kaminetsky, MD; Vincent Lucente, MD; Sonia Dutta, MD; Peter Sand, MD; Kimberly Ferrante, MD
Study Design:
Prospective, multi-center, single-arm trial
Participants:
133 adults aged 18-80 with daily UUI episodes
Intervention:
Subcutaneous tibial neurostimulator (eCoin) implantation
Primary Outcome:
≥50% improvement in UUI episodes at 48 weeks
Secondary Outcomes:
3-day voiding diary data, patient-reported outcomes
Procedure Time:
20.8 minutes
Safety:
One serious device-related adverse event (localized infection resolved by explant)
Year:
2025
Region / city:
Not specified
Topic:
Antibiotic efficacy, nanotechnology
Document type:
Research article
Organization / institution:
Not specified
Author:
Diana Marcos Fernandez, Natalia Alfaro, Andrea Cutró, Diego Pazos-Castro, Inés Oliver Camacho, Luis Tebar Palmero, Ana Bouchet, Axel Hollmann
Target audience:
Researchers, healthcare professionals, microbiologists
Effective period:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2023
Region / city:
USA, UK, AUS, ITA, PL, JP, KR
Topic:
Medical Research
Document Type:
Research Article
Institution:
Multiple medical institutions
Author:
M. Lia Palomba, Manish R. Patel, Toby A. Eyre, Wojciech Jurczak, et al.
Target Audience:
Medical professionals, researchers
Period of validity:
Not specified
Approval Date:
Not specified
Date of amendments:
Not specified
Year:
2017
Region / City:
Chennai, Tamil Nadu, India
Topic:
Antimicrobial research, oral pathogens
Document Type:
Research article
Author:
Murali Iyangar Radhika, Devaraj Ezhilarasan, Prakasam Gopinath
Target Audience:
Researchers, microbiologists, pharmacologists
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / city:
Rohtak, Haryana
Topic:
Schizophrenia, Psychiatric Rehabilitation
Document Type:
Research Article
Organization / Institution:
Institute of Mental Health, Pt. B.D. Sharma University of Health Sciences, PGIMS
Author:
Dr. Aakanksha Kharb, Dr. Nandini Lamba, Dr. Pradeep Kumar
Target Audience:
Mental Health Professionals, Researchers, Medical Students
Period of Action:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Region / city:
USA, Austria, Norway, Brazil, Canada, Colombia, Denmark, UK, Australia
Subject:
Human papillomavirus vaccine, Cervical cancer prevention
Document Type:
Clinical trial report
Organization / institution:
Multiple research institutions and hospitals
Authors:
Warner K. Huh, Elmar A. Joura, Anna R. Giuliano, Ole-Erik Iversen, Rosires Pereira de Andrade, Kevin A. Ault, Deborah Bartholomew, Ramon M. Cestero, Edison N. Fedrizzi, Angelica L. Hirschberg, Marie-Hélène Mayrand, Angela Maria Ruiz-Sternberg, Jack T. Stapleton, Dorothy J. Wiley, Alex Ferenczy, Robert Kurman, Brigitte M. Ronnett, Mark H. Stoler, Jack Cuzick, Suzanne M. Garland, Susanne K. Kjaer, Oliver M. Bautista, Richard Haupt, Erin Moeller, Michael Ritter, Christine C. Roberts, Christine Shields, Alain Luxembourg
Target Audience:
Healthcare professionals, Researchers, Public health policymakers
Period of validity:
6 years
Approval date:
2026
Date of changes:
2026
Keywords:
human papillomavirus, vaccine, cervical cancer, persistent infection, cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia
Funding:
Merck & Co., Inc., Kenilworth, NJ, USA
Clinical trial registration:
NCT00543543 (https://clinicaltrials.gov/ct2/show/NCT00543543
Note:
)
Word count:
4963/4500
References:
30/30
Contextual description:
This clinical trial report presents the long-term efficacy, immunogenicity, and safety outcomes of a nine-valent HPV vaccine for preventing HPV-related cervical diseases in young women.
Year:
2021
Region / City:
Żory, Poland
Topic:
Pain Management, Dental Surgery
Document Type:
Research Article
Institution:
Medical University of Silesia in Katowice
Authors:
Hanna Frelich-Truchel, Rafał Wiench, Piotr Wichary, Henryk Frelich, Hanna Misiołek
Target Audience:
Medical professionals, dental surgeons, anesthesiologists
Period of validity:
N/A
Date of Approval:
2021
Date of Changes:
N/A
Year:
2024
Region / City:
Guangzhou, Guangdong Province, China
Topic:
Hepatocellular carcinoma, postoperative radiation therapy
Document Type:
Research article
Organization / Institution:
The Third Affiliated Hospital of Sun Yat-sen University, Qilu Hospital, Shandong University, The First Affiliated Hospital, Guangzhou Medical University
Authors:
Gao-Yuan Yang, Zhi-Wei He, Yong-Chang Tang, Feng Yuan, Ming-Bo Cao, Yu-Peng Ren, Yu-Xuan Li, Xiao-Rui Su, Zhi-Cheng Yao, Mei-Hai Deng
Target Audience:
Medical researchers, clinicians specializing in oncology and hepatobiliary surgery
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Revision:
December 9, 2023
Date of Acceptance:
January 9, 2024
Funding:
The Science and Technology Plan Project of Guangzhou, National Natural Science Foundation Cultivation Project of The Third Affiliated Hospital of Sun Yat-sen University, Natural Science Foundation of Guangdong Province, CSCO-Roche Joint Cancer Research Fund
Year:
2023
Region / City:
Multiple international locations
Topic:
Clinical trial, treatment for eosinophilic granulomatosis with polyangiitis
Document Type:
Research Article
Organization / Institution:
GlaxoSmithKline (GSK), National Institutes of Health (NIH), various academic institutions
Author:
Michael E. Wechsler, Praveen Akuthota, David Jayne, Paneez Khoury, Amy Klion, Carol A. Langford, Peter A. Merkel, Frank Moosig, Ulrich Specks, Maria C. Cid, Raashid Luqmani, Judith Brown, Stephen Mallett, Richard Philipson, Steve W. Yancey, Jonathan Steinfeld, Peter F. Weller, Gerald J. Gleich
Target Audience:
Medical professionals, researchers, healthcare providers
Period of Action:
52 weeks
Approval Date:
2023-01-01
Date of Revisions:
None