Site organization and management.

Abstract:

:The principal investigator is responsible for everything involved in the conduct of a clinical research study. Prior to the initiation of any clinical trial, an investigator must become acquainted with the material requirements, personnel needs, and best practices involved in the conduct of the trial. Commitment to a clinical trial should not be taken lightly because even a simple study may require a major investment of staff, space, and time. Standard operating procedures help to standardize staff training and improve regulatory compliance. Reasons for participation in clinical research may differ between community and academic gastroenterologists, but responsibility for patient care, regulatory requirements, and assumption of accountability are identical. Careful attention to the details of site organization, administrative requirements, and patient recruitment and retention all contribute to the successful performance of clinical research.

journal_name

Inflamm Bowel Dis

authors

Wolf DC,Katz S,Safdi MA,Sandler RS,Lewis JD

doi

10.1097/01.mib.0000184848.61687.52

keywords:

subject

Has Abstract

pub_date

2005-11-01 00:00:00

pages

S29-33

eissn

1078-0998

issn

1536-4844

pii

00054725-200511001-00006

journal_volume

11 Suppl 1

pub_type

杂志文章
  • Use of Social Media for Health-Related Tasks by Adolescents With Inflammatory Bowel Disease: A Step in the Pathway of Transition.

    abstract:Background:Social media is commonly used among the adolescent and young adult population, including those with chronic diseases. For adults, these platforms have been shown to be a major source of health information. Our aims were to explore how youth with inflammatory bowel disease (IBD) use social media for (1) disea...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1093/ibd/izy021

    authors: Szeto W,van der Bent A,Petty CR,Reich J,Farraye F,Fishman LN

    更新日期:2018-05-18 00:00:00

  • Therapy with anti-TNFα antibody enhances number and function of Foxp3(+) regulatory T cells in inflammatory bowel diseases.

    abstract:BACKGROUND:Inflammatory bowel diseases (IBDs) are associated with up-regulation of TNFα, hyperactivation of proinflammatory effector T cells (Teffs) and inefficient control by regulatory CD4(+) CD25(+) Foxp3(+) T cells (Tregs). The aim of this prospective study was to investigate the short-term impact of treatment of I...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1002/ibd.21308

    authors: Boschetti G,Nancey S,Sardi F,Roblin X,Flourié B,Kaiserlian D

    更新日期:2011-01-01 00:00:00

  • Dilation of colonic strictures by intralesional injection of infliximab in patients with Crohn's colitis.

    abstract:BACKGROUND:Intestinal stenosis is a frequent complication of Crohn's disease, often leading to repeated bowel obstruction and surgery. The prevalence of small bowel stenosis has ranged from 20% to 40% and from 7% to 15% in patients with colonic disease. Although balloon dilation is the initial preferred approach, many ...

    journal_title:Inflammatory bowel diseases

    pub_type: 临床试验,杂志文章,评审

    doi:10.1002/ibd.20318

    authors: Swaminath A,Lichtiger S

    更新日期:2008-02-01 00:00:00

  • Mesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitis.

    abstract:BACKGROUND:High doses of mesalazine usually result in an inconvenient dosage schedule and reduced compliance. The goal of this trial was to compare the effects of mesalazine 4 g daily given as prolonged-release granules in packets of 1 g with that of prolonged-release tablets of 0.5 g. METHODS:Two hundred twenty-seven...

    journal_title:Inflammatory bowel diseases

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/00054725-200108000-00009

    authors: Farup PG,Hinterleitner TA,Lukás M,Hébuterne X,Rachmilewitz D,Campieri M,Meier R,Keller R,Rathbone B,Oddsson E

    更新日期:2001-08-01 00:00:00

  • Connecting Families: A Pediatric IBD Center's Development and Implementation of a Volunteer Parent Mentor Program.

    abstract::It is estimated that over one million people are living with inflammatory bowel disease (IBD) in the United States and that 20-25% of those are children. Pediatric IBD presents with more severe and extensive disease when compared to adults. As with all pediatric chronic illnesses, the patient as well as their parents ...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/MIB.0000000000000733

    authors: Donegan A,Boyle B,Crandall W,Dotson JL,Lemont C,Moon T,Kim SC

    更新日期:2016-05-01 00:00:00

  • Racial differences in disease phenotypes in patients with Crohn's disease.

    abstract:BACKGROUND:Our objectives were to assess the differences in perforating disease behavior, disease severity, and extraintestinal manifestations (EIM) in patients with Crohn's disease (CD) by race. MATERIALS AND METHODS:We identified outpatients with CD evaluated at the University of Maryland Gastroenterology Faculty Pr...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/01.MIB.0000217767.98389.20

    authors: Cross RK,Jung C,Wasan S,Joshi G,Sawyer R,Roghmann MC

    更新日期:2006-03-01 00:00:00

  • Socioeconomic and psychological factors associated with nonadherence to treatment in inflammatory bowel disease patients: results of the ISSEO survey.

    abstract:BACKGROUND:Adherence to treatment is a key condition in preventing relapses in inflammatory bowel disease (IBD). The aims of this study were specifically to study socioeconomic and psychological factors and adherence to treatment in a large cohort of patients. METHODS:A questionnaire concerning demographic, clinical, ...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1002/ibd.21482

    authors: Nahon S,Lahmek P,Saas C,Durance C,Olympie A,Lesgourgues B,Gendre JP

    更新日期:2011-06-01 00:00:00

  • Natural history of Crohn's disease: comparison between childhood- and adult-onset disease.

    abstract:BACKGROUND:Childhood-onset Crohn's disease (CD) might reflect a more severe form of disease. To test this hypothesis we analyzed the long-term natural history of CD in an adult cohort of patients with childhood-onset compared to adult-onset CD. METHODS:We selected 206 childhood-onset CD patients among 2992 adult patie...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1002/ibd.21152

    authors: Pigneur B,Seksik P,Viola S,Viala J,Beaugerie L,Girardet JP,Ruemmele FM,Cosnes J

    更新日期:2010-06-01 00:00:00

  • Anti-TNF-α Use During the Third Trimester of Pregnancy in Women with Moderate-severe Inflammatory Bowel Disease and the Risk of Preterm Birth and Low Birth Weight.

    abstract:BACKGROUND:Little knowledge exists about the association between anti-tumor necrosis factor-alpha (anti-TNF-α) therapy for inflammatory bowel disease during late pregnancy and adverse birth outcomes. We aimed to examine whether treatment with anti-TNF-α during the third trimester affected preterm birth and low birth we...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/MIB.0000000000001234

    authors: Kammerlander H,Nielsen J,Knudsen T,Kjeldsen J,Friedman S,Nørgård BM

    更新日期:2017-11-01 00:00:00

  • Interleukin 23 in Crohn's disease.

    abstract::: Crohn's disease (CD) is a lifelong inflammatory condition with underlying environmental and genetic components. CD affects multiple parts of the gastrointestinal tract, and it has a growing incidence in Western societies. IL-23 receptor variants have been identified as susceptibility or resistance factors for CD in ...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章,评审

    doi:10.1097/01.MIB.0000442014.52661.20

    authors: Eken A,Singh AK,Oukka M

    更新日期:2014-03-01 00:00:00

  • Words fail me: the verbal IQ deficit in inflammatory bowel disease and irritable bowel syndrome.

    abstract:BACKGROUND:Many chronic illnesses are accompanied by impaired cognitive functioning. In people with Inflammatory Bowel Disease (IBD), there is some research to suggest a decrement in verbal IQ (VIQ), when compared to people with Irritable Bowel Syndrome (IBS) and healthy controls. Although this is an important finding,...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1002/ibd.20837

    authors: Dancey CP,Attree EA,Stuart G,Wilson C,Sonnet A

    更新日期:2009-06-01 00:00:00

  • Enterotoxigenic bacteroides fragilis: a potential instigator of colitis.

    abstract:BACKGROUND:Inflammatory bowel disease (IBD) is proposed to result from a dysregulated mucosal immune response to the colonic flora in genetically susceptible individuals. Enterotoxigenic Bacteroides fragilis (ETBF), a molecular subclass of the common human commensal, B. fragilis, has been associated with IBD. This stud...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1002/ibd.20265

    authors: Rabizadeh S,Rhee KJ,Wu S,Huso D,Gan CM,Golub JE,Wu X,Zhang M,Sears CL

    更新日期:2007-12-01 00:00:00

  • Resources Utilization and Costs the Year Before and After Starting Treatment with Adalimumab in Crohn's Disease Patients.

    abstract:BACKGROUND:This study examines the resources utilization in patients with Crohn's disease (CD) during the year before (Y - 1) and after (Y + 1) starting treatment with adalimumab and the drug's efficiency. METHODS:Observational, multicenter, prospective cohort study of patients with CD naive to biological drugs. The p...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章,多中心研究

    doi:10.1097/MIB.0000000000000413

    authors: Saro C,Ceballos D,Muñoz F,De la Coba C,Aguilar MD,Lázaro P,Iglesias-Flores E,Barreiro-de Acosta M,Hernández-Durán MD,Barrio J,Riestra S,Fernández Salazar L,EFICADEC Researchers Group.

    更新日期:2015-07-01 00:00:00

  • Knowledge of Fecal Calprotectin and Infliximab Trough Levels Alters Clinical Decision-making for IBD Outpatients on Maintenance Infliximab Therapy.

    abstract:BACKGROUND:Infliximab is an effective therapy for inflammatory bowel disease (IBD). However, more than 50% of patients lose response. Empiric dose intensification is not effective for all patients because not all patients have objective disease activity or subtherapeutic drug level. The aim was to determine how an obje...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/MIB.0000000000000376

    authors: Huang VW,Prosser C,Kroeker KI,Wang H,Shalapay C,Dhami N,Fedorak DK,Halloran B,Dieleman LA,Goodman KJ,Fedorak RN

    更新日期:2015-06-01 00:00:00

  • Targeted inhibition of heat shock protein 90 suppresses tumor necrosis factor-α and ameliorates murine intestinal inflammation.

    abstract::Inflammatory bowel diseases are chronic intestinal inflammatory diseases thought to reflect a dysregulated immune response. Although antibody-based inhibition of tumor necrosis factor-α (TNF-α) has provided relief to many inflammatory bowel diseases patients, these therapies are either ineffective in a patient subset ...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/01.MIB.0000442839.28664.75

    authors: Collins CB,Strassheim D,Aherne CM,Yeckes AR,Jedlicka P,de Zoeten EF

    更新日期:2014-04-01 00:00:00

  • Severe Legionella pneumophila pneumonia following infliximab therapy in a patient with Crohn's disease.

    abstract:BACKGROUND:Immunosuppressive therapy with anti-TNF-alpha antibodies is effective in patients with inflammatory bowel disease (IBD). However, there is an increased risk for infections associated with this therapy. METHODS:Here, we report the case of a 58-year-old patient with Crohn's disease (CD) treated with steroids ...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1002/ibd.20866

    authors: Beigel F,Jürgens M,Filik L,Bader L,Lück C,Göke B,Ochsenkühn T,Brand S,Seiderer J

    更新日期:2009-08-01 00:00:00

  • Pediatric Inflammatory Bowel Diseases: Should We Be Looking for Kidney Abnormalities?

    abstract:Background:Kidney disease has been reported in adults with inflammatory bowel disease (IBD) and is regarded an extraintestinal manifestation or more rarely a side effect of the medical treatment. Methods:In this cross-sectional study we describe the extent of kidney pathology in a cohort of 56 children with IBD. Blood...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1093/ibd/izy166

    authors: Lauritzen D,Andreassen BU,Heegaard NHH,Klinge LG,Walsted AM,Neland M,Nielsen RG,Wittenhagen P

    更新日期:2018-11-29 00:00:00

  • Objective structured clinical examination as a novel tool in inflammatory bowel disease fellowship education.

    abstract:BACKGROUND:Experiential learning in medical education, as exemplified by objective structured clinical examinations (OSCEs), is a well-validated approach for improving trainee performance. Furthermore, the Accreditation Council for Graduate Medical Education has identified OSCEs as an ideal method for assessing the cor...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/MIB.0000000000000317

    authors: Wolff MJ,Balzora S,Poles M,Zabar S,Mintah A,Wong L,Weinshel E,Malter LB

    更新日期:2015-04-01 00:00:00

  • AVX-470: a novel oral anti-TNF antibody with therapeutic potential in inflammatory bowel disease.

    abstract:BACKGROUND:Inflammatory bowel disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract, which is currently treated with injected monoclonal antibodies specific for tumor necrosis factor (TNF). We developed and characterized AVX-470, a novel polyclonal antibody specific for human TNF. We evaluated t...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/MIB.0b013e3182a11958

    authors: Bhol KC,Tracey DE,Lemos BR,Lyng GD,Erlich EC,Keane DM,Quesenberry MS,Holdorf AD,Schlehuber LD,Clark SA,Fox BS

    更新日期:2013-10-01 00:00:00

  • IFNG rs1861494 polymorphism is associated with IBD disease severity and functional changes in both IFNG methylation and protein secretion.

    abstract:BACKGROUND:Mucosal expression of interferon (IFN)-γ plays a pivotal role in the pathogenesis of inflammatory bowel disease (IBD) and IBD risk regions flank IFNG. The conserved IFNG rs1861494 T/C introduces a new CpG methylation site, is associated with disease severity and lack of therapeutic response in other infectio...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/MIB.0000000000000172

    authors: Gonsky R,Deem RL,Landers CJ,Haritunians T,Yang S,Targan SR

    更新日期:2014-10-01 00:00:00

  • Assessing Small Bowel Stricturing and Morphology in Crohn's Disease Using Semi-automated Image Analysis.

    abstract:BACKGROUND:Evaluating structural damage using imaging is essential for the evaluation of small intestinal Crohn's disease (CD), but it is limited by potential interobserver variation. We compared the agreement of enterography-based bowel damage measurements collected by experienced radiologists and a semi-automated ima...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1093/ibd/izz196

    authors: Stidham RW,Enchakalody B,Waljee AK,Higgins PDR,Wang SC,Su GL,Wasnik AP,Al-Hawary M

    更新日期:2020-04-11 00:00:00

  • Efficacy of infliximab in intestinal Behçet's disease: a Korean multicenter retrospective study.

    abstract:BACKGROUND:Although infliximab is widely accepted as a therapeutic option for inflammatory bowel disease, its therapeutic efficacy for the treatment of intestinal Behçet's disease (BD) is unknown. We investigated the short-term and long-term response rates to infliximab in intestinal BD and predictive factors of sustai...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章,多中心研究

    doi:10.1097/MIB.0b013e31828f19c9

    authors: Lee JH,Cheon JH,Jeon SW,Ye BD,Yang SK,Kim YH,Lee KM,Im JP,Kim JS,Lee CK,Kim HJ,Kim EY,Kim KO,Jang BI,Kim WH

    更新日期:2013-08-01 00:00:00

  • Serological antibodies in inflammatory bowel disease: a systematic review.

    abstract::The diagnosis of inflammatory bowel disease (IBD) is traditionally based on a combination of clinical, endoscopic, histological, and radiological criteria. However, further testing is needed in cases of diagnostic uncertainty and in predicting disease course. This systematic review focuses on the potential for 10 sero...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章,评审

    doi:10.1002/ibd.21903

    authors: Prideaux L,De Cruz P,Ng SC,Kamm MA

    更新日期:2012-07-01 00:00:00

  • Co-prescribing azathiopurine or 6-mercaptopurine and 5-aminosalicylate compounds in ulcerative colitis.

    abstract:BACKGROUND:A total of 254 senior consultant gastroenterologists with valid e-mail addresses were identified from the membership list of the British Society of Gastroenterology (BSG) 2007. METHODS:They were sent by e-mail a questionnaire which dealt with aspects of clinical practice and addressed cancer prevention in u...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1002/ibd.20750

    authors: Mayberry H,Moshkovska T,Mayberry JF

    更新日期:2009-02-01 00:00:00

  • Critical appraisal of the current practice in murine TNBS-induced colitis.

    abstract::There is no standard practice in the induction of colitis by 2,4,6-trinitrobenzene sulfonic acid. In this review the current practice in 2,4,6-trinitrobenzene sulfonic acid colitis is studied using 20 recently published articles. We compare the different protocols, discuss the mechanism of disease and give recommendat...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章,评审

    doi:10.1097/01.mib.0000227817.54969.5e

    authors: te Velde AA,Verstege MI,Hommes DW

    更新日期:2006-10-01 00:00:00

  • Smoking cessation alters intestinal microbiota: insights from quantitative investigations on human fecal samples using FISH.

    abstract:BACKGROUND:There has been a dramatic increase in investigations on the potential mechanistic role of the intestinal microbiota in various diseases and factors modulating intestinal microbial composition. We recently reported on intestinal microbial shifts after smoking cessation in humans. In this study, we aimed to co...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1097/MIB.0000000000000129

    authors: Biedermann L,Brülisauer K,Zeitz J,Frei P,Scharl M,Vavricka SR,Fried M,Loessner MJ,Rogler G,Schuppler M

    更新日期:2014-09-01 00:00:00

  • The Use of Cannabinoids in Colitis: A Systematic Review and Meta-Analysis.

    abstract:Background:Clinical trials investigating the use of cannabinoid drugs for the treatment of intestinal inflammation are anticipated secondary to preclinical literature demonstrating efficacy in reducing inflammation. Methods:We systematically reviewed publications on the benefit of drugs targeting the endo-cannabinoid ...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章,meta分析

    doi:10.1093/ibd/izy014

    authors: Couch DG,Maudslay H,Doleman B,Lund JN,O'Sullivan SE

    更新日期:2018-03-19 00:00:00

  • Combination of innate and adaptive immune alterations increased the likelihood of fibrostenosis in Crohn's disease.

    abstract:BACKGROUND:Mutations in the nucleotide oligomerization domain-2 (NOD2) gene and positive antibodies to microbial antigens have been found to be associated with the Crohn's disease (CD) phenotype, fibrostenosis. The aim of this study was to confirm these relationships in a large cohort of CD patients and to determine th...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1002/ibd.21196

    authors: Ippoliti A,Devlin S,Mei L,Yang H,Papadakis KA,Vasiliauskas EA,McGovern DP,Abreu MT,Melmed G,Shaye O,Enayati P,Chen G,Choi J,Taylor K,Landers CJ,Rotter JI,Targan SR

    更新日期:2010-08-01 00:00:00

  • The Relationship Between Adverse Childhood Experiences and Health Care Use in the Manitoba IBD Cohort Study.

    abstract:BACKGROUND:We aimed to determine the prevalence of adverse childhood experiences (ACEs) in persons with inflammatory bowel disease (IBD) and whether having ACEs was associated with health care utilization post-IBD diagnosis. METHOD:Three hundred forty-five participants from the population-based Manitoba IBD Cohort Stu...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1093/ibd/izz054

    authors: Witges KM,Bernstein CN,Sexton KA,Afifi T,Walker JR,Nugent Z,Lix LM

    更新日期:2019-09-18 00:00:00

  • Defect in CEACAM family member expression in Crohn's disease IECs is regulated by the transcription factor SOX9.

    abstract:BACKGROUND:CEACAM1, CEACAM5, and CEACAM6 represent 3 of the CEACAM (carcinoembryonic antigen-related cell adhesion molecule) subfamily members expressed on intestinal epithelial cells (IECs). Deficiency in their expression, as seen in inflammatory bowel disease (IBD), results in the lack of activation of CD8+ regulator...

    journal_title:Inflammatory bowel diseases

    pub_type: 杂志文章

    doi:10.1002/ibd.21023

    authors: Roda G,Dahan S,Mezzanotte L,Caponi A,Roth-Walter F,Pinn D,Mayer L

    更新日期:2009-12-01 00:00:00