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Clinical Activity (clinical + activity)
Terms modified by Clinical Activity Selected AbstractsOral, colonic-release low-molecular-weight heparin: an initial open study of Parnaparin-MMX for the treatment of mild-to-moderate left-sided ulcerative colitisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2008L. PASTORELLI Summary Background, Efficacy of heparin and low-molecular-weight heparins (LMWHs) in inflammatory bowel disease (IBD) treatment has been suggested. The multimatrix oral formulation MMX releases active drugs in the colon, avoiding systemic absorption. Parnaparin sodium is the LMWH chosen to be carried in the MMX formulation. Aim, To assess the safety of three different oral dosages (70, 140 and 210 mg once daily) of Parnaparin-MMX (CB-01-05) in left-sided ulcerative colitis (UC). Methods, Left-sided UC patients, with a mild-to-moderate relapse were enrolled. All patients received Parnaparin-MMX for 8 weeks. Clinical Activity Index (CAI), Disease Activity Index (DAI), Endoscopic Activity Index and IBD-QoL were assessed throughout the study. A strict clinical and laboratory follow-up, including assessment of anti-factor Xa activity, was performed. Clinical remission was defined as CAI <4. Results, Ten UC patients were enrolled. One patient retired for clinical deterioration. No relevant side effects, including either interference with haemostasis parameters or increased bleeding, were observed. At the end of the treatment, seven patients (70%) were in clinical remission, only one achieving endoscopic healing. Mean final CAI, DAI and IBD-QoL scores were significantly improved from baseline. Conclusions, Parnaparin-MMX appears to be a safe treatment option in mild-to-moderate UC. Controlled studies are warranted. [source] Correlation of C-reactive protein with clinical, endoscopic, histologic, and radiographic activity in inflammatory bowel diseaseINFLAMMATORY BOWEL DISEASES, Issue 8 2005Craig A Solem MD Abstract Introduction: We sought to examine the relationship between C-reactive protein (CRP) and clinical, endoscopic, histologic, and radiographic activity in inflammatory bowel disease (IBD). Methods: All IBD patients at our institution between January 2002 and August 2003 who had a CRP, colonoscopy, and either small bowel follow-through (SBFT) or CT enterography (CTE) performed within 14 days were identified. Clinical activity was assessed retrospectively through review of the medical record. Logistic regression was used in Crohn's disease (CD) patients to estimate the odds ratio (OR) with 95% confidence intervals for an elevated CRP. Associations were assessed using Fisher exact test in ulcerative colitis (UC) patients due to small sample size. Results: One-hundred four CD patients (46% males) and 43 UC and indeterminate colitis patients (44% males) were identified. In CD patients, moderate-severe clinical activity (OR, 4.5; 95% CI, 1.1-18.3), active disease at colonoscopy (OR, 3.5; 95% CI, 1.4-8.9), and histologically severe inflammation (OR, 10.6; 95% CI; 1.1-104) were all significantly associated with CRP elevation. Abnormal small bowel radiographic imaging was not significantly associated with CRP elevation. In UC patients, CRP elevation was significantly associated with severe clinical activity, elevation in sedimentation rate, anemia, hypoalbuminemia, and active disease at ileocolonoscopy, but not with histologic inflammation. Conclusions: CRP elevation in IBD patients is associated with clinical disease activity, endoscopic inflammation, severely active histologic inflammation (in CD patients), and several other biomarkers of inflammation, but not with radiographic activity. [source] Integrating pediatric hospitalists in the academic health science center: Practice and perceptions in a canadian center,,JOURNAL OF HOSPITAL MEDICINE, Issue 4 2010FRCPC, Sanjay Mahant MD Abstract BACKGROUND: The integration of hospitalists in academic settings has been identified as a challenge to the hospitalist movement. The Division of Pediatric Medicine, Hospital for Sick Children, Toronto, was established in 1981, providing a rich resource to examine this field in the academic context and inform academic program development. OBJECTIVES: To explore the characteristics, practice, perceptions, and contributions of pediatric hospital medicine in an academic health science center (AHSC). METHODS: A cross-sectional survey of physicians attending on the pediatric medicine inpatient unit (PMIU) (n = 20). RESULTS: Clinical activity included attending on the PMIU, consultation and comanagement outside the PMIU, and outpatient care of "hospital intense" patients. There was a high level of engagement in research, education, and quality improvement activities. Perceived advantages to a career as a hospitalist included: working in a team; generalist approach to care; stability relative to community practice; intellectually stimulating and rewarding work; and growing area for scholarship. Perceived disadvantages to a career as a hospitalist included: burnout; recognition and respect; and lack of long-term relationships with patients. Themes regarding barriers to establishing a career as a hospitalist in an AHSC were as follows: burnout; time and skills to develop an academic niche; balance between clinical and academic priorities; and system for career advancement. CONCLUSIONS: The contributions of pediatric hospitalists to the academic mission were diverse. Fellowship training, faculty development, and balance between time allocated to direct patient care and academic pursuits should be defined. This will help ensure career development, viability, and realization of excellence in the academic context. Journal of Hospital Medicine 2010;5:228,233. © 2010 Society of Hospital Medicine. [source] Clinical trial: five or ten cycles of granulocyte,monocyte apheresis show equivalent efficacy and safety in ulcerative colitisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 12 2010A. U. DIGNASS Aliment Pharmacol Ther,31, 1286,1295 Summary Background, Ulcerative colitis is characterized by leucocyte infiltration into the colonic mucosa. Granulocyte,monocyte apheresis depletes these cells. Aim, To assess the non-inferiority of 5,10 apheresis treatments in patients with steroid-dependent or steroid-refractory ulcerative colitis. Methods, A total of 196 adults with moderate,severe ulcerative colitis were randomized 1:1 to 5 (n = 96) or 10 (n = 90) open label apheresis treatments. The primary endpoint was non-inferiority of clinical activity index score after 12 weeks. Results, The intent-to-treat population comprised 82 and 80 patients for the 5- and 10-treatment groups, respectively. The difference between the two groups in mean clinical activity index was 0.24 with an upper 95% confidence interval of 1.17, which was below a predefined non-inferiority threshold of 1.33. Clinical activity index score improved from baseline in both groups (from 8.7 to 5.6 with 5 treatments, and from 8.8 to 5.4 with 10), with no significant difference between the groups (P = 0.200). Outcomes for the 5- and 10-treatment groups were similar , Clinical remission: 44% and 40%, respectively (P = 0.636); clinical response: 56% and 59%, respectively (P = 0.753). The treatment was well tolerated in both groups. Conclusions, This prospective study comparing apheresis regimens in ulcerative colitis demonstrates that 5 treatments were not inferior to 10 treatments in steroid-refractory or -dependent ulcerative colitis. [source] Undergraduate teaching in gerodontology in Leipzig and Zürich , a comparison of different approachesGERODONTOLOGY, Issue 3 2009Ina Nitschke Objective:, To evaluate undergraduate students' attitude towards the clinical components of the Leipzig (LPEG) and Zürich (ZPEG) Programmes of Education in Gerodontology. Background:, Undergraduate student education is the seedbed for conscientious professionals. Extramural clinical education contributes to the formation of positive attitudes. Students in Zürich participate in three clinical activities (in-house gerodontology clinic, extramural acute geriatrics ward, mobile dental service), in Leipzig they visit a long-term care facility on six occasions within 4 years. Methods:, A structured questionnaire with 10 items was administered to students in Leipzig [n = 34, 70.6% female, mean age 25.8 (SD 3.04) years] at the beginning and after completion of gerodontology training and to students in Zürich [n = 33, 48.5% female, mean age 27.0 (SD 3.28) years] on three occasions after clinical training. Students indicated the degree of their agreement with seven statements presented using a 5-point scale. A choice of responses which characterised the course was offered for assessment. Results:, Close collaboration with dental tutors, while self-treating patients in the mobile dental service (mobiDentÔ) attracted the most positive responses. Ratings from students completing their training in Leipzig were less favourable than their initial responses. Conclusion:, The lack of a dental service and Leipzig students' inability to offer treatment in the presence of disease was associated with frustrations. Practical training should go beyond dental examinations at a long-term care facility and include the opportunity for dental treatment. Personnel and equipment required for mobile treatment exceed resources available at most German dental schools. [source] Impact of COPD severity on physical disability and daily living activities: EDIP-EPOC I and EDIP-EPOC II studiesINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 5 2009J. M. Rodriguez Gonzalez-Moro Summary Aims:, The severity of chronic obstructive pulmonary disease (COPD) is associated to patients' health-related quality of life (HRQL). Physical impairment increasingly affects daily activities creating economic, social and personal burden for patients and their families. This burden should be considered in the management of COPD patients; therefore, we intended to assess the impact of the disease severity on physical disability and daily activities. Methods:, Two epidemiological observational cross-sectional descriptive studies were carried out in 1596 patients with moderate COPD and 2012 patients with severe or very severe COPD in the routine clinical practice. Demographic and basic clinical-epidemiological data were collected and patients completed questionnaires to assess their physical disability because of COPD [Medical Research Council (MRC)], COPD repercussion on daily activities [London Chest Activity of Daily Living (LCADL)], job, economy and family habits and their health status [EQ-5D visual analogue scale (VAS)]. Results:, In all, 37% of severe/very severe COPD patients and 10% of moderate (p < 0.0001) had MRC grades 4 and 5. Mean global LCADL was significantly higher in severe/very severe than in moderate patients [29.6 (CI 95%: 28.91,30.25) vs. 21.4 (CI 95%: 20.8,21.9); p < 0.0001]. COPD job impact and economic and family habits repercussions were significantly higher and health status significantly worse in severe/very severe cases than in patients with moderate COPD. Conclusions:, COPD severity is highly associated with physical disability by MRC grading, with functionality on daily activities and with impairment of other social and clinical activities. Moderate COPD patients show already a significant degree of impairment in all these parameters. [source] Experiences of Students in Pediatric Nursing Clinical CoursesJOURNAL FOR SPECIALISTS IN PEDIATRIC NURSING, Issue 2 2001Marilyn H. Oermann ISSUES AND PURPOSE. Learning may be inhibited if students experience undue stress in the clinical setting. This study described the stresses, challenges, and emotions experienced by pediatric nursing students. DESIGN AND METHODS. Students (n = 75) completed a modified Pagana Clinical Stress Questionnaire at the end of their pediatric nursing clinical course. The comparison group of students (n = 383) was enrolled in nonpediatric clinical courses in the same nursing programs. RESULTS. The most stressful aspect of clinical practice was giving medications to children. High stress scores were related to more fear and disappointment in clinical practice. Students who experienced high stress were less stimulated by their clinical activities and developed less confidence in practice. PRACTICE IMPLICATIONS. Knowledge of students' perceptions of clinical stress can help educators and clinicians promote a positive and rewarding clinical atmosphere. [source] The Nurse Educator's clinical roleJOURNAL OF ADVANCED NURSING, Issue 1 2005Odette Griscti MHSc RN Aim., This paper reports a two-phase descriptive study exploring the clinical role of the nurse educator in Malta. Background., Previous studies indicate a number of similarities and differences in the clinical role of nurse educators by country of practice. These include importance assigned to the role, factors inhibiting/facilitating the role, means to eliminate barriers to the role, and perceptions of the ideal role. Design and methods., Data were collected using both quantitative and qualitative strategies. The quantitative phase involved asking all educators to fill in a time log of their academic and clinical activities for a 2-week period. In the qualitative phase, the first author interviewed five educators, five nurses and five students about their perceptions of factors which impact the nurse educator's clinical role, as well as what the ideal clinical role of the nurse educator should be. Findings., Maltese nurse educators allot minimal time to their clinical role. Main reasons cited included workload, perceived lack of control over the clinical area, and diminished clinical competence. Nurse educators who frequented the clinical settings (who were either university or joint university and health service employees) where the study took place perceived that employment inequities among the various categories of nurse educators played an important role in the amount of time dedicated by each group to their clinical roles, and the importance individuals in these groups assigned to that role. The majority of interviewees saw the current role of nurse educators in Malta as preparing students for successful completion of the didactic sections of their programme, rather than preparing them with all the knowledge and clinical skills necessary to be competent practitioners. Participants considered that, when in clinical areas, nurse educators did focus on their students, as they should. However, they also thought that they often did not take the opportunity to forge links with professional staff. Conclusion., The clinical role of the Maltese nurse educator needs to be more multifaceted in approach. [source] The double helix of activity and scholarship: building a medical education career with limited resourcesMEDICAL EDUCATION, Issue 1 2008Page S Morahan Context, Creating respected scholarship from educational and clinical activities is challenging for medical school faculty members. In the USA and Europe, criteria for ,scholarship' has broadened and enriched. However, in developing countries, promotion systems generally continue to emphasise traditional laboratory or clinical research. Objective, This paper sets forth a broad conception of scholarship and provides international distribution venues that reinforce the importance of scholarly activity corresponding to clinical and educational work. Methods, Information sources about non-traditional scholarship included 50 medical school faculty from 20 economically developing nations plus senior faculty from throughout the USA. Resources for distribution venues were drawn from a citation index search, a literature search and Google. Results, The authors provide resources for faculty advancement, including examples of non-traditional scholarship that meet rigorous criteria, and a comprehensive list of venues for the dissemination of educational materials and studies. They give a relative value process for academic work to assist faculty in developing educational scholarship. Finally, they propose a double helix model for academic advancement, consisting of 2 congruent helices with the same axis, 1 representing educational, service or clinical activity and the other scholarly achievement. Conclusions, These materials and the double helix model will support faculty and promotion committees, especially those from schools that have not yet broadened their view of scholarship, to envisage a realistic starting point and see how educational and clinical activities can generate internationally recognised, high-quality scholarship. [source] How residents learn: qualitative evidence for the pivotal role of clinical activitiesMEDICAL EDUCATION, Issue 8 2007P W Teunissen Objectives, Medical councils worldwide have outlined new standards for postgraduate medical education. This means that residency programmes will have to integrate modern educational views into the clinical workplace. Postgraduate medical education is often characterised as a process of learning from experience. However, empirical evidence regarding the learning processes of residents in the clinical workplace is lacking. This qualitative study sought insight into the intricate process of how residents learn in the clinical workplace. Methods, We carried out a qualitative study using focus groups. A grounded theory approach was used to analyse the transcribed tape recordings. A total of 51 obstetrics and gynaecology residents from teaching hospitals and affiliated general hospitals participated in 7 focus group discussions. Participants discussed how they learn and what factors influence their learning. Results, An underlying theoretical framework emerged from the data, which clarified what happens when residents learn by doing in the clinical workplace. This framework shows that work-related activities are the starting point for learning. The subsequent processes of ,interpretation' and ,construction of meaning' lead to refinement and expansion of residents' knowledge and skills. Interaction plays an important role in the learning process. This is in line with both cognitivist and sociocultural views on learning. Conclusions, The presented theoretical framework of residents' learning provides much needed empirical evidence for the actual learning processes of residents in the clinical workplace. The insights it offers can be used to exploit the full educational potential of the clinical workplace. [source] An appraisal of medical students' reflection-in-learningMEDICAL EDUCATION, Issue 3 2000Sobral Introduction How do students reflect as they strive for some control of learning early in their clinical activities? The purpose of this study was to examine the reflection-in-learning profile of medical students as they started their clinical apprenticeship. Methods A measure of reflection-in-learning was used to appraise the level and direction of change of reflection in relation to a course experience. The study involved 103 medical students of both sexes who were beginning clinical activities. Assessments of self-regulation of learning, of the meaningfulness of the learning experience, and of diagnostic thinking were also obtained. Results The results showed that 81% of the students had an increase in scores for reflection-in-learning between the beginning and the end of a course. At the end of the course, the level of reflection-in-learning was significantly associated with self-perceived competence for self-regulated learning and with the meaningfulness of the learning experience. In the following term, students who had high reflection-in-learning scores at the end of the course had higher grade-point averages and greater self-reported diagnostic ability in comparison with those with low scores. Conclusions There was some evidence of an improved quality of reflection as the students strive for some control of learning. Overall, the findings support the idea that a greater effort at reflection is associated with a more positive learning experience. They also suggest that reflection-in-learning is related to readiness for self-regulation of learning and may be conducive to enhanced diagnostic ability. In conclusion, measuring reflection-in-learning may be a useful tool in the appraisal of medical students' learning profiles. [source] Use of theory to interpret elements of changeTHE JOURNAL OF CONTINUING EDUCATION IN THE HEALTH PROFESSIONS, Issue 4 2002Dr. Henry B. Slotnick PhD, PhD Visiting Professor Abstract Actions useful in reducing unacceptable variation in physicians' clinical activities have been identified through critical reviews of randomized controlled trials, and, from them, Richard Grol proposed six elements of effective change for mounting programs to improve clinical practice. The elements include consideration of the complex reality of clinical practice, attention to the designated change, analysis of the target group and setting, mixed interventions to address needs, and a plan of action. Although empirically based, the elements lack a theoretical underpinning that explains why the elements work. This article interprets the elements using theories separately advanced by Dewey, Slotnick, and Wenger to suggest ways for understanding what studies have shown. [source] Day Float: An Alternative to the Night Float Coverage System for Residency Programs,THE LARYNGOSCOPE, Issue 7 2008Amar C. Suryadevara MD Abstract Objectives: The Accreditation Council for Graduate Medical Education (ACGME) has mandated an 80-hour work week that has resulted in changes to many residency programs. In otolaryngology, most programs have switched to either home call or night float systems. Our department covers all of the maxillofacial trauma and backup airway calls, which has made it difficult to employ a home call system. Instead of a night float coverage system, our program implemented a day float coverage system that allows the residents to participate in a 24-hour call period. After call and sign-out, the residents go home; however, their clinical duties are covered by the day float resident. Study Design: A brief review of the literature pertaining to call coverage systems followed by a description of our day float system. Residents who have participated in either night float, day float, or both systems were then surveyed regarding their experiences or perceptions of both systems. Methods: A nine-question survey was handed out to our otolaryngology residents and their responses were recorded. Results: The averaged responses strongly favored the day float over the night float coverage system regardless of the level of training and the systems in which the residents have participated. Conclusions: The day float coverage system is favored by residents in our program. It allows for a more attending-like 24-hour period of call, continuity of care, attendance at educational activities, and more time with family. In addition, it eliminates a prolonged period devoid of clinical activities. [source] Evaluating performance of and organisational capacity to deliver brief interventions in Aboriginal and Torres Strait Islander medical servicesAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 1 2010Katie Panaretto Abstract Objective: This study assessed brief intervention (BI) activity and organisation capacity for smoking, nutrition, alcohol and physical activity (SNAP framework) and key clinical prevention activities in four Aboriginal and Torres Strait Islander medical services in Queensland. Methods: A mixed methods design was used including: staff surveys of knowledge and attitudes (n=39), focus groups to discuss perceived barriers and enablers and chart audits (n=150) to quantify existing BI activity. Results: Of 50 clinical staff, 46 participated in the staff survey and focus groups across the four sites. BI was perceived to be important. There was significant variation in completion of records for SNAP risk factors, key clinical and BI activities across the sites. At least one SNAP factor status was recorded in 130/150 (86.7%) patient charts audited and there was a significant trend of increased recording of SNAP factors with increasing number of patient visits. Of those identified at risk 78% received at least one BI. Where risk was identified 65/96 (67.7%) patients required multiple BIs. BI for tobacco use was consistently high across all sites. Only one site recorded regular care planning and Adult Health Checks. Impacting factors included leadership, high staff turnover, multiple medical records and staff health status. Conclusions: Inflexible staff training, competing health priorities and high levels of staff turnover were identified as key barriers to the delivery of BI in clinical settings. The data suggests a good base of existing BI activity for smoking and key clinical activities which may improve with further support. [source] Epigenetic therapy in myelodysplastic syndromesEUROPEAN JOURNAL OF HAEMATOLOGY, Issue 6 2010Caterina Musolino Abstract The wide spectrum of clonal hematopoietic disorders that fall under the broad diagnostic category of myelodysplastic syndromes (MDS) consist of a family of bone marrow malignancies , with ineffective, inadequate, and dysplastic hematopoiesis, and with an increased risk of life-threatening infections, bleeding, and progression to acute myeloid leukemia (AML) , that are characterized by a deep heterogeneity on the clinical, biologic and prognostic level. The intrinsic complexity of this group of disorders and the frequent association with one or more comorbidities have limited for many years the number of effective treatment options available: most patients are, indeed, still managed by supportive care measures, with just a minority of them being eligible for allogeneic stem cell transplantation, which is still the only potentially curative modality. In the last two decades, the progressively better understanding of MDS biology has shown how an abnormal epigenetic modulation might play a crucial part in the pathogenesis and in the process of biologic evolution of these disorders. Moreover, pharmacological agents that target the so-called epigenome have shown a significant clinical activity for diverse hematologic malignancies, including MDS. The aim of this review is to highlight recent developments within the context of current knowledge of MDS and its altered epigenetic regulation and to recall the experimental steps that have brought to the clinical development and application of epigenetic modifiers, such as azacytidine and decitabine, trying to explain the biologic rationale for their use in this setting. [source] Phase II study of arsenic trioxide and ascorbic acid for relapsed or refractory lymphoid malignancies: a Wisconsin Oncology Network study,HEMATOLOGICAL ONCOLOGY, Issue 1 2009JE Chang Abstract Arsenic trioxide (As2O3) has established clinical activity in acute promyelocytic leukaemia and has pre-clinical data suggesting activity in lymphoid malignancies. Cell death from As2O3 may be the result of oxidative stress. Agents which deplete intracellular glutathione, such as ascorbic acid (AA), may potentiate arsenic-mediated apoptosis. This multi-institution phase II study investigated a novel dosing schedule of As2O3 and AA in patients with relapsed or refractory lymphoid malignancies. Patients received As2O3 0.25,mg/kg IV and AA 1000,mg IV for five consecutive days during the first week of each cycle followed by twice weekly infusions during weeks 2,6. Cycles were repeated every 8 weeks. The primary end point was objective response. In a subset of patients, sequential levels of intracellular glutathione and measures of Bcl-2 and Bax gene expression were evaluated in peripheral blood mononuclear cells during treatment. Seventeen patients were enrolled between March 2002 and February 2004. The median age was 71, and the majority of enrolled patients had non-Hodgkin's lymphoma (12/17). Sixteen patients were evaluable, and one patient with mantle cell lymphoma achieved an unconfirmed complete response after five cycles of therapy for an overall response rate of 6%. The trial, which had been designed as a two-stage study, was closed after the first stage analysis due to lack of activity. Haematologic toxicities were the most commonly reported events in this heavily pre-treated population, and comprised the majority of grade 3 and 4 toxicities. Intracellular depletion of glutathione was not consistently observed during treatment. As2O3 and AA in this novel dosing strategy was generally well tolerated but had limited activity in patients with relapsed and refractory lymphoid malignancies. Copyright © 2008 John Wiley & Sons, Ltd. [source] N-3 polyunsaturated fatty acid diet therapy for patients with inflammatory bowel diseaseINFLAMMATORY BOWEL DISEASES, Issue 10 2010Kan Uchiyama MD Abstract Background: N-3 polyunsaturated fatty acids (PUFA) are considered important pharmaconutrients for modulating mucosal immunity and therapeutic responses in patients with inflammatory bowel disease (IBD). We investigated the influence of diet therapy involving the use of an "n-3 PUFA food exchange table" (n-3DP) on the fatty acid composition of the erythrocyte membranes of IBD patients and its remission-maintaining effects. Methods: We analyzed the fatty acid composition of the erythrocyte membrane before and after n-3DP intervention in 20 initial-onset IBD patients who had not undergone any dietary intervention. We then analyzed it again and evaluated disease activity after 12,18 months intervention in 230 IBD patients (168 ulcerative colitis, 62 Crohn's disease; follow-up group) in whom n-3DP was introduced after remission had been achieved. The follow-up group was divided into remission and relapse groups. Results: In the 20 initial-onset patients, the mean n-3/n-6 ratio significantly increased after intervention (0.41 ± 0.16 versus 0.70 ± 0.20; P < 0.001). In the follow-up group the ratio in the remission group (n = 145) was significantly higher than that in the relapse group (n = 85) (0.65 ± 0.28 versus 0.53 ± 0.18; P < 0.001). The ratio significantly decreased in those who suffered a relapse after the beginning of treatment (P < 0.01). Conclusions: N-3DP significantly increased the erythrocyte membrane n-3/n-6 ratio in IBD patients, and this ratio was significantly higher in the remission group, suggesting that n-3DP alters the fatty acid composition of the cell membrane and influences clinical activity in IBD patients. (Inflamm Bowel Dis 2010) [source] Ulcerative colitis: Correlation of the Rachmilewitz endoscopic activity index with fecal calprotectin, clinical activity, C-reactive protein, and blood leukocytesINFLAMMATORY BOWEL DISEASES, Issue 12 2009Alain M. Schoepfer MD Abstract Background: The accuracy of noninvasive markers for the detection of endoscopically active ulcerative colitis (UC) according the Rachmilewitz Score is so far unknown. The aim was to evaluate the correlation between endoscopic disease activity and fecal calprotectin, Clinical Activity Index, C-reactive protein (CRP), and blood leukocytes. Methods: UC patients undergoing colonoscopy were prospectively enrolled and scored independently according the endoscopic and clinical part of the Rachmilewitz Index. Patients and controls provided fecal and blood samples for measuring calprotectin, CRP, and leukocytes. Results: Values in UC patients (n = 134) compared to controls (n = 48): calprotectin: 396 ± 351 versus 18.1 ± 5 ,g/g, CRP 16 ± 13 versus 3 ± 2 mg/L, blood leukocytes 9.9 ± 3.5 versus 5.4 ± 1.9 g/L (all P < 0.001). Endoscopic disease activity correlated closest with calprotectin (Spearman's rank correlation coefficient r = 0.834), followed by Clinical Activity Index (r = 0.672), CRP (r = 0.503), and leukocytes (r = 0.461). Calprotectin levels were significantly lower in UC patients with inactive disease (endoscopic score 0,3, calprotectin 42 ± 38 ,g/g), compared to patients with mild (score 4,6, calprotectin 210 ± 121 ,g/g, P < 0.001), moderate (score 7,9, calprotectin 392 ± 246 ,g/g, P = 0.002), and severe disease (score 10,12, calprotectin 730 ± 291 ,g/g, P < 0.001). The overall accuracy for the detection of endoscopically active disease (score ,4) was 89% for calprotectin, 73% for Clinical Activity Index, 62% for elevated CRP, and 60% for leukocytosis. Conclusions: Fecal calprotectin correlated closest with endoscopic disease activity, followed by Clinical Activity Index, CRP, and blood leukocytes. Furthermore, fecal calprotectin was the only marker that reliably discriminated inactive from mild, moderate, and highly active disease, which emphasizes its usefulness for activity monitoring. Inflamm Bowel Dis 2009 [source] Correlation of C-reactive protein with clinical, endoscopic, histologic, and radiographic activity in inflammatory bowel diseaseINFLAMMATORY BOWEL DISEASES, Issue 8 2005Craig A Solem MD Abstract Introduction: We sought to examine the relationship between C-reactive protein (CRP) and clinical, endoscopic, histologic, and radiographic activity in inflammatory bowel disease (IBD). Methods: All IBD patients at our institution between January 2002 and August 2003 who had a CRP, colonoscopy, and either small bowel follow-through (SBFT) or CT enterography (CTE) performed within 14 days were identified. Clinical activity was assessed retrospectively through review of the medical record. Logistic regression was used in Crohn's disease (CD) patients to estimate the odds ratio (OR) with 95% confidence intervals for an elevated CRP. Associations were assessed using Fisher exact test in ulcerative colitis (UC) patients due to small sample size. Results: One-hundred four CD patients (46% males) and 43 UC and indeterminate colitis patients (44% males) were identified. In CD patients, moderate-severe clinical activity (OR, 4.5; 95% CI, 1.1-18.3), active disease at colonoscopy (OR, 3.5; 95% CI, 1.4-8.9), and histologically severe inflammation (OR, 10.6; 95% CI; 1.1-104) were all significantly associated with CRP elevation. Abnormal small bowel radiographic imaging was not significantly associated with CRP elevation. In UC patients, CRP elevation was significantly associated with severe clinical activity, elevation in sedimentation rate, anemia, hypoalbuminemia, and active disease at ileocolonoscopy, but not with histologic inflammation. Conclusions: CRP elevation in IBD patients is associated with clinical disease activity, endoscopic inflammation, severely active histologic inflammation (in CD patients), and several other biomarkers of inflammation, but not with radiographic activity. [source] Impairment of health-related quality of life in patients with inflammatory bowel disease: A Spanish multicenter studyINFLAMMATORY BOWEL DISEASES, Issue 5 2005Dr. F Casellas PhD Abstract Background: Inflammatory bowel disease impairs patients' perception of health and has a negative impact on health-related quality of life (HRQOL). Most studies include patients from a single hospital. This may bias limit results through the use of small patient samples and/or samples within a restricted disease spectrum. Methods: HRQOL was measured in patients with ulcerative colitis (UC) and Crohn's disease (CD) from 9 hospitals located in different geographical areas in Spain using 2 questionnaires: the Spanish version of the Inflammatory Bowel Disease Questionnaire (IBDQ) and the EuroQol. Results are expressed as medians. Results: The study included 1156 patients (528 patients with UC and 628 with CD; median age, 35 yr; slight predominance of women, 617 versus 539). HRQOL worsened in parallel with disease severity to a similar extent in both UC (IBDQ scores of 6.1, 4.7, and 4.0 for the 3 disease severity groups, respectively) and CD (IBDQ scores of 6.1, 5.0, and 4.1, respectively). A similar inverse relation between clinical activity and quality of life was observed when EuroQol preference values were used. All 5 dimensions of the IBDQ showed significantly lower scores in patients with active UC and CD than in patients in remission. The pattern of scores by IBDQ dimensions differed between patients in relapse (who scored worse on the digestive symptoms dimension) and patients in remission. Variables related with disease activity, time of evolution since diagnosis and female sex, were significantly associated with having a worse perception of HRQOL. The type of disease or geographical area of residence did not influence results on the IBDQ. Conclusions: UC and CD impair patients' HRQOL, and the degree of impairment depends on disease activity but is independent of the type of disease and place of residence. [source] EGFR and KRAS status of primary sarcomatoid carcinomas of the lung: Implications for anti-EGFR treatment of a rare lung malignancyINTERNATIONAL JOURNAL OF CANCER, Issue 10 2009Antoine Italiano Abstract Sarcomatoid carcinomas (SC) of the lung are uncommon malignant tumors composed of carcinomatous and sarcomatous cell components and characterized by a more aggressive outcome than other histological subtypes of nonsmall cell lung cancer (NSCLC). Although epidermal growth factor receptor (EGFR)-targeted therapies have emerged as a promising therapeutic approach in patients with advanced typical NSCLC such as adenocarcinoma, the potential clinical activity of these drugs in lung SC is still unknown. To investigate this point, we have analyzed the status of 4 EGFR pathways biomarkers in a series of lung SC. EGFR protein expression, EGFR gene copy number, EGFR mutational status and KRAS mutational status were assessed in a series of 22 consecutive cases of primary lung SC. EGFR protein overexpression was observed in all the cases. High level of polysomy (,4 copies of the gene in >40% of cells) was detected in 5 cases (23%). No EGFR mutation was detected. KRAS mutations were found in 8 patients (38%; Gly12Cys in 6 cases and Gly12Val in 2 cases). The consistent EGFR protein overexpression and the high rate of KRAS mutation may contribute to the poorer outcome of lung SC in comparison with typical NSCLC. The rare incidence of increased EGFR gene copy number, the lack of EGFR mutation and the high rate of KRAS mutation observed in our series also suggest that most patients with lung SC are not likely to benefit from anti-EGFR therapies. © 2009 UICC [source] Immunization with a P53 synthetic long peptide vaccine induces P53-specific immune responses in ovarian cancer patients, a phase II trial,INTERNATIONAL JOURNAL OF CANCER, Issue 9 2009Ninke Leffers Abstract The prognosis of ovarian cancer, the primary cause of death from gynecological malignancies, has only modestly improved over the last decades. Immunotherapy is one of the new treatment modalities explored for this disease. To investigate safety, tolerability, immunogenicity and obtain an impression of clinical activity of a p53 synthetic long peptide (p53-SLP) vaccine, twenty patients with recurrent elevation of CA-125 were included, eighteen of whom were immunized 4 times with 10 overlapping p53-SLP in Montanide ISA51. The first 5 patients were extensively monitored for toxicity, but showed no , grade 3 toxicity, thus accrual was continued. Overall, toxicity was limited to grade 1 and 2, mostly locoregional, inflammatory reactions. IFN-, producing p53-specific T-cell responses were induced in all patients who received all 4 immunizations as measured by IFN-, ELISPOT. An IFN-, secretion assay showed that vaccine-induced p53-specific T-cells were CD4+, produced both Th1 and Th2 cytokines as analyzed by cytokine bead array. Notably, Th2 cytokines dominated the p53-specific response. P53-specific T-cells were present in a biopsy of the last immunization site of at least 9/17 (53%) patients, reflecting the migratory capacity of p53-specific T-cells. As best clinical response, stable disease evaluated by CA-125 levels and CT-scans, was observed in 2/20 (10%) patients, but no relationship was found with vaccine-induced immunity. This study shows that the p53-SLP vaccine is safe, well tolerated and induces p53-specific T-cell responses in ovarian cancer patients. Upcoming trials will focus on improving T helper-1 polarization and clinical efficacy. © 2009 UICC [source] Indirect modulation of dopamine D2 receptors as potential pharmacotherapy for schizophrenia: III.JOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 3 2002Retinoids Present antipsychotic drugs, whose clinical activity correlates with direct binding to dopamine D2 or other receptors, alleviate some of the symptoms of schizophrenia, but not all and not completely in many patients. In continuation of our overview of potential novel antipsychotic pharmacotherapy that would be based upon indirect modulation of dopamine or other neurotransmitter functioning, we focus in this article on the postulated use of retinoid analogs as novel antipsychotic agents. Several lines of evidence can be viewed as implicating retinoid dysregulation in schizophrenia, either as a causative or contributory factor. It has been proposed that using retinoid analogs to alter the downstream expression of dopamine D2 receptors might represent a novel approach to the treatment of the disease or amelioration of symptoms when used either as monotherapy or as adjunct pharmacotherapy to dopamine D2 receptor antagonists. [source] Serum YKL-40 as a marker of disease activity and stricture formation in patients with Crohn's diseaseJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 8pt2 2008Yusuf Erzin Abstract Background and Aim:, YKL-40 is secreted by macrophages and neutrophils and is a growth factor for vascular endothelial cells and fibroblasts. Elevated serum levels of YKL-40 have been reported in patients with various inflammatory conditions and ongoing fibrosis. The aim of this study was to investigate the relationship between serum concentrations of YKL-40 and disease activity, acute phase reactants, and the presence of strictures in patients with Crohn's disease (CD). Methods:, We studied the serum concentrations of YKL-40 in 41 patients with CD, in which 12 had an endoscopically- or radiologically-proven stricture formation. Forty-six age- and sex-matched healthy volunteers served as controls and a multivariate regression analysis was performed to find out the independent predictors of intestinal strictures and clinical activity. Results:, The serum YKL-40 concentrations in the patients were significantly higher than that in the healthy controls (105.69 ± 88.08 ng/mL [range 20.23,333.57]vs 44.92 ± 24.89 ng/mL [range 18.31,113.43], P = 0.000) and patients with a stricture formation had significantly higher YKL-40 levels than those without strictures (167.50 ± 119.30 ng/mL [range 23.62,333.57]vs 80.12 ± 56.38 ng/mL [range 20.23,259.19], P = 0.003). Significant correlations were noted between YKL-40 levels and clinical activity (r = 0.681; P = 0.000) and the presence of intestinal strictures (r = 0.457; P = 0.003). The multivariate regression analysis found the serum YKL-40 levels to be an independent predictor of intestinal strictures (P = 0.001) and clinical activity (P = 0.001). Conclusion:, Patients with CD, particularly those with a stricture formation, have significantly higher levels of YKL-40. YKL-40 seems to be a useful marker of disease activity as well as stricture formation in patients with CD. [source] Reluctant but resourceful middle managers: the case of nurses in the NHSJOURNAL OF NURSING MANAGEMENT, Issue 1 2006BSc (Hons), GRAEME CURRIE PhD This study counters the widely held view that middle managers have little to contribute to strategic change in health care organizations. In particular, it argues that middle managers with a nursing background that manage clinical activity should be involved in strategic change beyond mere implementation of decisions made by executive management. Constraints upon this are noted , the power of doctors and central government intervention , that means middle managers enact a semiautonomous strategic role. Antecedents for the semiautonomous role are investment in organization and management development, developing lateral organizational structures that allow middle managers to make a contribution to the development, as well as the implementation of strategy and allowing middle managers to interact with other stakeholders outside the confines of the organization. [source] Clinical trial: five or ten cycles of granulocyte,monocyte apheresis show equivalent efficacy and safety in ulcerative colitisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 12 2010A. U. DIGNASS Aliment Pharmacol Ther,31, 1286,1295 Summary Background, Ulcerative colitis is characterized by leucocyte infiltration into the colonic mucosa. Granulocyte,monocyte apheresis depletes these cells. Aim, To assess the non-inferiority of 5,10 apheresis treatments in patients with steroid-dependent or steroid-refractory ulcerative colitis. Methods, A total of 196 adults with moderate,severe ulcerative colitis were randomized 1:1 to 5 (n = 96) or 10 (n = 90) open label apheresis treatments. The primary endpoint was non-inferiority of clinical activity index score after 12 weeks. Results, The intent-to-treat population comprised 82 and 80 patients for the 5- and 10-treatment groups, respectively. The difference between the two groups in mean clinical activity index was 0.24 with an upper 95% confidence interval of 1.17, which was below a predefined non-inferiority threshold of 1.33. Clinical activity index score improved from baseline in both groups (from 8.7 to 5.6 with 5 treatments, and from 8.8 to 5.4 with 10), with no significant difference between the groups (P = 0.200). Outcomes for the 5- and 10-treatment groups were similar , Clinical remission: 44% and 40%, respectively (P = 0.636); clinical response: 56% and 59%, respectively (P = 0.753). The treatment was well tolerated in both groups. Conclusions, This prospective study comparing apheresis regimens in ulcerative colitis demonstrates that 5 treatments were not inferior to 10 treatments in steroid-refractory or -dependent ulcerative colitis. [source] Clinical trial: oral colon-release parnaparin sodium tablets (CB-01-05 MMX®) for active left-sided ulcerative colitisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2010G. CELASCO Aliment Pharmacol Ther 31, 375-386 Summary Background, The administration of parnaparin sodium as oral colon-release tablets (CB-01-05 MMX®) has been proposed as a novel approach for the treatment of ulcerative colitis (UC). Aim, To assess the efficacy and the tolerability of 8 weeks' oral daily administration of 210 mg of parnaparin sodium compared with placebo in subjects treated with stable-doses of oral aminosalicylates. Methods, This multicenter, randomized, double-blind proof of concept trial compared the efficacy of CB-01-05 MMX® 210 mg tablets to placebo in 141 subjects with mild to moderately active left-sided UC treated with stable-doses of aminosalicylates. The efficacy was assessed by clinical activity index (CAI), endoscopic index (EI) and histological score (HS). Results, A total of 121 subjects (61 in test group and 60 in control group) formed the per protocol (PP) population. After 8 weeks of treatment, clinical remission was achieved in 83.6% of the CB-01-05 MMX® group, and in 63.3% in the comparator group (P = 0.011). This effect was also significantly evident in the test group at week 4 (P = 0.028). A significant difference was also detected in rectal bleeding, (disappeared respectively in 75.4% and 55.0%; P = 0.018), and in mucosal friability (recovered respectively in 80.3% and in 56.7%; P = 0.005). Conclusions, CB-01-05 MMX® was safe and significantly effective in treating subjects with mild-to-moderate left-sided UC treated with stable-doses of aminosalicylates. [source] Early changes in rectal nitric oxide and mucosal inflammatory mediators in Crohn's colitis in response to infliximab treatmentALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2007T. LJUNG SUMMARY Background Treatment with tumor necrosis factor-, monoclonal antibody (infliximab) reduces clinical activity and intestinal inflammation in Crohn's disease. Aim To study the time-course of the effects of infliximab with reference to mucosal cytokine and inducible nitric oxide synthase expression. Methods Thirty-two patients with Crohn's disease were treated with single dose infliximab (5 mg/kg). Disease activity was assessed days 1, 3, 7 and 28 using Harvey,Bradshaw index. Rectal nitric oxide levels were determined and rectal biopsies collected before treatment, 1 h after infusion and on days 3, 7 and 28. Immunohistochemical staining against inducible nitric oxide synthase, tumor necrosis factor-,, interleukin-1, and interferon-, were performed. Results Clinical response was seen in 14 patients with down-regulation of global immunohistochemistry expression, reaching nadir day 3. Rectal nitric oxide was increased at baseline (3578 ± 1199 parts per billion, ppb) compared with controls (89 ± 13 ppb) (P < 0.001). In patients with clinical response, rectal nitric oxide decreased from 3926 ± 1687 ppb to 1050 ± 428 ppb day 28 (P < 0.05). Conclusions Down-regulation of mucosal inflammatory mediators occurs after infliximab. Rectal nitric oxide levels parallel down-regulation of inducible nitric oxide synthase, tumor necrosis factor-,, interleukin-1, and interferon-, and may serve as a quantitative biomarker of intestinal inflammation. [source] Randomized placebo-controlled trial assessing the effect of bifidobacteria-fermented milk on active ulcerative colitisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2004K. Kato Summary Background :,Probiotics are efficacious for treating and maintaining remission of ulcerative colitis. Aim :,To conduct a randomized placebo-controlled trial of bifidobacteria-fermented milk supplementation as a dietary adjunct in treating active ulcerative colitis. Methods :,Twenty patients with mild to moderate, active, ulcerative colitis randomly received 100 mL/day of bifidobacteria-fermented milk or placebo for 12 weeks with conventional treatment. Results :,Clinical and endoscopic activity indices and histological scores were similar in the two groups before treatment. Although improvements were significant in both groups, the clinical activity index was significantly lower in the bifidobacteria-fermented milk than in the placebo group after treatment. The post-treatment endoscopic activity index and histological score were significantly reduced in the bifidobacteria-fermented milk, but not the placebo group. Increases in faecal butyrate, propionate and short-chain fatty acid concentrations were significant in the bifidobacteria-fermented milk, but not the placebo group. No adverse effects were observed in either group. Conclusion :,Supplementation with this bifidobacteria-fermented milk product is safe and more effective than conventional treatment alone, suggesting possible beneficial effects in managing active ulcerative colitis. This is a pilot study and further larger studies are required to confirm the result these preliminary results. [source] The double helix of activity and scholarship: building a medical education career with limited resourcesMEDICAL EDUCATION, Issue 1 2008Page S Morahan Context, Creating respected scholarship from educational and clinical activities is challenging for medical school faculty members. In the USA and Europe, criteria for ,scholarship' has broadened and enriched. However, in developing countries, promotion systems generally continue to emphasise traditional laboratory or clinical research. Objective, This paper sets forth a broad conception of scholarship and provides international distribution venues that reinforce the importance of scholarly activity corresponding to clinical and educational work. Methods, Information sources about non-traditional scholarship included 50 medical school faculty from 20 economically developing nations plus senior faculty from throughout the USA. Resources for distribution venues were drawn from a citation index search, a literature search and Google. Results, The authors provide resources for faculty advancement, including examples of non-traditional scholarship that meet rigorous criteria, and a comprehensive list of venues for the dissemination of educational materials and studies. They give a relative value process for academic work to assist faculty in developing educational scholarship. Finally, they propose a double helix model for academic advancement, consisting of 2 congruent helices with the same axis, 1 representing educational, service or clinical activity and the other scholarly achievement. Conclusions, These materials and the double helix model will support faculty and promotion committees, especially those from schools that have not yet broadened their view of scholarship, to envisage a realistic starting point and see how educational and clinical activities can generate internationally recognised, high-quality scholarship. [source] | ||||||||||||||||||||||||||||||||||