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Sample records for arthritis clinical trial

  1. RANDOMIZED CLINICAL TRIAL IN CHIKUNGUNYA ARTHRITIS CASES

    Directory of Open Access Journals (Sweden)

    Mansoor

    2012-11-01

    Full Text Available ABSTRACT: Chikungunya virus is no stranger to the Indian sub- continent. Since its first isolation in Calcutta [1] in 1963, there have been several reports of chikung unya virus infection in different parts of India [2], [3], [4]. The last outbreak of chikungunya virus infection o ccurred in India in 1971. Subsequently there has been no activ e or passive surveillance carried out in the country and therefore, it ‘seemed’ that the virus h ad ‘disappeared’ from the subcontinent [5] However, recent reports of large scale outbreaks of fever caused by chikungunya virus infection in several parts of Southern India have confirmed th e re-emergence of this virus. It has been estimated that over 1,80,000 cases have occurred in India since December 2005 [6] Andhra Pradesh (AP was the first state to report this dise ase in December 2005, and one of the worst affected (over 80,000 suspected cases . Over 12% of patients who contract chikungunya virus infection develop chronic joint symptoms [7] . OBJECTIVE: To test the efficacy of chloroquine in reducing the pain of chikungunya induced arthritis a s compared to paracetamol. METHODOLOGY: A Randomized Clinical Trial was carried out in a c ommunity attached to urban health centre of PESIMSR, Kuppam during August 2006. Among the 132 cases of arthritis, 86 persons were selected based on their availability and consent to participate. They were divided into two randomly assigned groups namely Cat egory–1(Chloroquine group and Category–2 ( Paracetamol group. Chloroquine tablet -155 mg and Paracetamol tablet - 500 mg were administered as a single dose to the two groups respectively. The groups were followed up for 8 days and the results were analyzed. STATISTICAL ANALYSIS: Analysis was carried out by using S.P.S.S. package. Asymptoic test statistic an d X 2 MH (Chi square test were used to evaluate the effect of the drugs. RESULTS OF THE STUDY: The decrease of pain in chikungunya arthritis cases was

  2. Prospective Clinical Trial for Septic Arthritis

    DEFF Research Database (Denmark)

    Schmal, Hagen; Bernstein, Anke; Feucht, Matthias J;

    2016-01-01

    clinical trial and the cytokine composition of effusions (n = 76) was analyzed. Characteristics of epidemiology and disease severity were correlated with levels of cytokines with known roles in cartilage turnover and degradation. Results. Higher synovial IL-1β concentrations were associated with clinical......-2, and BMP-7. Infections with Staphylococcus species induced higher IL-1β expression but less cartilage destruction than other bacteria. Conclusion. Articular infections have bacteria-specific implications on cartilage metabolism. Collagen type II cleavage products reliably mark destruction, which...... is associated with upregulation of typical cartilage turnover cytokines. This trial is registered with DRKS00003536, MISSinG....

  3. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials

    DEFF Research Database (Denmark)

    Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip

    2016-01-01

    OBJECTIVE: To identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities. METHODS: We conducted (1) a systematic literature review (SLR) of domains assessed in PsA; (2) international focus groups t...

  4. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations.

    NARCIS (Netherlands)

    Aletaha, D.; Landewe, R.B.; Karonitsch, T.; Bathon, J.; Boers, M.; Bombardier, C.; Bombardieri, S.; Choi, H.; Combe, B.; Dougados, M.; Emery, P.; Gomez-Reino, J.; Keystone, E.C.; Koch, G.; Kvien, T.K.; Martin-Mola, E.; Matucci-Cerinic, M.; Michaud, K.; O'Dell, J.; Paulus, H.; Pincus, T.; Richards, P.; Simon, L.; Siegel, J.; Smolen, J.S.; Sokka, T.; Strand, V.; Tugwell, P.; Heijde, D. van der; Riel, P.L.C.M. van; Vlad, S.; Vollenhoven, R. van; Ward, M.; Weinblatt, M.; Wells, G.A.; White, B.; Wolfe, F.; Zhang, B.; Zink, A.; Felson, D.T.

    2008-01-01

    OBJECTIVE: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). METHODS: The project followed the EULAR standardized operating procedures, w

  5. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations.

    NARCIS (Netherlands)

    Aletaha, D.; Landewe, R.B.; Karonitsch, T.; Bathon, J.; Boers, M.; Bombardier, C.; Bombardieri, S.; Choi, H.; Combe, B.; Dougados, M.; Emery, P.; Gomez-Reino, J.; Keystone, E.C.; Koch, G.; Kvien, T.K.; Martin-Mola, E.; Matucci-Cerinic, M.; Michaud, K.; O'Dell, J.; Paulus, H.; Pincus, T.; Richards, P.; Simon, L.; Siegel, J.; Smolen, J.S.; Sokka, T.; Strand, V.; Tugwell, P.; Heijde, D. van der; Riel, P.L.C.M. van; Vlad, S.; Vollenhoven, R. van; Ward, M.; Weinblatt, M.; Wells, G.A.; White, B.; Wolfe, F.; Zhang, B.; Zink, A.; Felson, D.T.

    2008-01-01

    OBJECTIVE: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). METHODS: The project followed the EULAR standardised operating procedures, w

  6. Improving physical activity in arthritis clinical trial (IMPAACT): study design, rationale, recruitment, and baseline data.

    Science.gov (United States)

    Chang, Rowland W; Semanik, Pamela A; Lee, Jungwha; Feinglass, Joseph; Ehrlich-Jones, Linda; Dunlop, Dorothy D

    2014-11-01

    Over 21 million Americans report an arthritis-attributable activity limitation. Knee osteoarthritis (OA) and rheumatoid arthritis (RA) are two of the most common/disabling forms of arthritis. Various forms of physical activity (PA) can improve a variety of health outcomes and reduce health care costs, but the proportion of the US population engaging in the recommended amount of PA is low and even lower among those with arthritis. The Improving Motivation for Physical Activity in Arthritis Clinical Trial (IMPAACT) is a randomized clinical trial that studied the effects of a lifestyle PA promotion intervention on pain and physical function outcomes. The IMPAACT intervention was based on a chronic care/disease management model in which allied health professionals promote patient self-management activities outside of traditional physician office encounters. The program was a motivational interviewing-based, individualized counseling and referral intervention, directed by a comprehensive assessment of individual patient barriers and strengths related to PA performance. The specific aims of IMPAACT were to test the efficacy of the IMPAACT intervention for persons with arthritis (N=185 persons with RA and 155 persons with knee OA) in improving arthritis-specific and generic self-reported pain and Physical Function outcomes, observed measures of function, and objectively measured and self-reported PA levels. Details of the stratified-randomized study design, subject recruitment, and data collection are described. The results from IMPAACT will generate empiric evidence pertaining to increasing PA levels in persons with arthritis and result in widely applicable strategies for health behavior change. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. Effects of aerobic exercise on hematologic indices of women with rheumatoid arthritis: A randomized clinical trial

    OpenAIRE

    2016-01-01

    Background: To investigate the effects of moderate aerobic exercise on the hemoglobin, hematocrit, and red blood cell (RBC) mass of women with rheumatoid arthritis (RA). Materials and Methods: This randomized clinical trial was conducted at the Specialized Clinic of Physical Medicine and Rehabilitation, Al-Zahra Hospital of Isfahan, during a 4-month period in 2014. We included patients with RA who did not have any malignancy and hematologic disorder. Two groups — one group receiving aerobic t...

  8. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis

    DEFF Research Database (Denmark)

    Heiligenhaus, Arnd; Foeldvari, Ivan; Edelsten, Clive

    2012-01-01

    To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis.......To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis....

  9. A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis.

    Science.gov (United States)

    Kirkham, Jamie J; Clarke, Mike; Williamson, Paula R

    2017-05-17

    Objective To assess the uptake of the rheumatoid arthritis core outcome set using a new assessment method of calculating uptake from data in clinical trial registry entries.Design Review of randomised trials.Setting ClinicalTrials.gov.Subjects 273 randomised trials of drug interventions for the treatment of rheumatoid arthritis and registered in ClinicalTrials.gov between 2002 and 2016. Full publications were identified for completed studies from information in the trial registry or from an internet search using Google and the citation database Web of Science.Main outcome measure The percentage of trials reporting or planning to measure the rheumatoid arthritis core outcome set calculated from the information presented in the trial registry and compared with the percentage reporting the rheumatoid arthritis core outcome set in the resulting trial publications.Results The full rheumatoid arthritis core outcome set was reported in 81% (116/143) of trials identified on the registry as completed (or terminated) for which results were found in either the published literature or the registry. For trials identified on the registry as completed (or terminated), using information only available in the registry gives an estimate for uptake of 77% (145/189).Conclusions The uptake of the rheumatoid arthritis core outcome set in clinical trials has continued to increase over time. Using the information on outcomes listed for completed or terminated studies in a trial registry provides a reasonable estimate of the uptake of a core outcome set and is a more efficient and up-to-date approach than examining the outcomes in published trial reports. The method proposed may provide an efficient approach for an up-to-date assessment of the uptake of the 300 core outcome sets already published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  10. Clinical trials documenting the efficacy of low-dose glucocorticoids in rheumatoid arthritis.

    Science.gov (United States)

    Pincus, Theodore; Cutolo, Maurizio

    2015-01-01

    Twelve clinical trials have documented that prednisone or prednisolone in doses of 10 mg/day or less is efficacious to improve function, maintain status and/or slow radiographic progression in patients with rheumatoid arthritis (RA). An early trial reported by de Andrade et al. [Ann Rheum Dis 1964;23:158-162] in 1964 indicated that 5 mg of prednisolone at night was preferred to 5 mg of prednisone in the morning. Harris et al. [J Rheumatol 1983;10:713-721] documented the efficacy of 5 mg/day of prednisone in a non-double-blind trial in 1983. Two important trials in the 1990s by Kirwan [N Engl J Med 1995;333:142-146] using 7.5 mg/day, and the COBRA study by Boers et al. [Lancet 1997;350:309-318] with step-down from 60 mg rapidly tapered to 5 mg/day led to strong advocacy of low-dose glucocorticoids. In 2002, the first Utrecht Study [Ann Intern Med 2002;136:1-12] indicated that 10 mg/day prednisone slowed radiographic progression, a finding confirmed and extended in 2005 by Svensson et al. [Arthritis Rheum 2005;52:3360-3370] with 7.5 mg/day, and Wassenberg et al. [Arthritis Rheum 2005;52:3371-3380] with 5 mg/day of prednisolone. In 2008, Buttgereit et al. [Lancet 2008;371:205-214] reported CAPRA-1, which documented that modified-release prednisone or prednisolone taken at bedtime led to lower morning stiffness and IL-6 levels compared to usual morning prednisone. In 2009, Pincus et al. [Ann Rheum Dis 2009;68:1715-1720] reported a withdrawal clinical trial, in which patients who took 3 mg/day were gradually withdrawn to placebo, and dropped out at a significantly higher rate than control patients who were 'withdrawn' to prednisone. In 2012, a second Utrecht Study [Ann Intern Med 2012;156:329-339], CAMERA-II, documented that 10 mg of prednisone added to a 'treat-to-target' strategy with methotrexate provided incremental slowing of radiographic progression. An Italian study of patients with early RA who received step-up disease-modifying antirheumatic drug therapy over 2

  11. Clinical trials of new drugs for the treatment of rheumatoid arthritis: focus on early disease.

    Science.gov (United States)

    Smolen, Josef S; Collaud Basset, Sabine; Boers, Maarten; Breedveld, Ferdinand; Edwards, Christopher J; Kvien, Tore K; Miossec, Pierre; Sokka-Isler, Tuulikki; van Vollenhoven, Ronald F; Abadie, Eric C; Bruyère, Olivier; Cooper, Cyrus; Mäkinen, Heidi; Thomas, Thierry; Tugwell, Peter; Reginster, Jean-Yves

    2016-07-01

    The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases convened a task force of experts in rheumatoid arthritis (RA) and clinical trial methodology to comment on the new draft 'Guideline on clinical investigation of medicinal products for the treatment of RA' released by the European Medicines Agency (EMA). Special emphasis was placed by the group on the development of new drugs for the treatment of early RA. In the absence of a clear definition of early RA, it was suggested that clinical investigations in this condition were conducted in disease-modifying antirheumatic drugs naïve patients with no more than 1 year disease duration. The expert group recommended using an appropriate improvement in disease activity (American College of Rheumatology (ACR) or Simplified/Clinical Disease Activity Index (SDAI/CDAI) response criteria) or low disease activity (by any score) as primary endpoints, with ACR/European League Against Rheumatism remission as a secondary endpoint. Finally, as compelling evidence showed that the Disease Acrivity Score using 28-joint counts (DAS28) might not provide a reliable definition of remission, or sometimes even low disease activity, the group suggested replacing DAS28 as a measurement instrument to evaluate disease activity in RA clinical trials. Proposed alternatives included SDAI, CDAI and Boolean criteria.

  12. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations.

    Science.gov (United States)

    Aletaha, D; Landewe, R; Karonitsch, T; Bathon, J; Boers, M; Bombardier, C; Bombardieri, S; Choi, H; Combe, B; Dougados, M; Emery, P; Gomez-Reino, J; Keystone, E; Koch, G; Kvien, T K; Martin-Mola, E; Matucci-Cerinic, M; Michaud, K; O'Dell, J; Paulus, H; Pincus, T; Richards, P; Simon, L; Siegel, J; Smolen, J S; Sokka, T; Strand, V; Tugwell, P; van der Heijde, D; van Riel, P; Vlad, S; van Vollenhoven, R; Ward, M; Weinblatt, M; Wells, G; White, B; Wolfe, F; Zhang, B; Zink, A; Felson, D

    2008-10-15

    To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). The project followed the EULAR standardized operating procedures, which use a three-step approach: 1) expert-based definition of relevant research questions (November 2006); 2) systematic literature search (November 2006 to May 2007); and 3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007). Eleven relevant questions were identified for the literature search. Based on the evidence from the literature, the expert panel recommended that each trial should report the following items: 1) disease activity response and disease activity states; 2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; 3) baseline disease activity levels (in general); 4) the percentage of patients achieving a low disease activity state and remission; 5) time to onset of the primary outcome; 6) sustainability of the primary outcome; 7) fatigue. These recommendations endorsed by EULAR and ACR will help harmonize the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.

  13. Limitations of clinical trials in chronic diseases: is the efficacy of methotrexate (MTX) underestimated in polyarticular psoriatic arthritis on the basis of limitations of clinical trials more than on limitations of MTX, as was seen in rheumatoid arthritis?

    Science.gov (United States)

    Pincus, Theodore; Bergman, Martin J; Yazici, Yusuf

    2015-01-01

    Clinical trials are the optimal method to establish efficacy of a drug versus placebo or another drug. Nonetheless, important limitations are seen, particularly in chronic diseases over long periods, although most are ignored. Pragmatic limitations of clinical trials include a relatively short observation period, suboptimal dosage schedules, suboptimal surrogate markers for long-term outcomes, statistically significant results which may not be clinically unimportant and vice versa. Even ideal clinical trials have intrinsic limitations, including the influence of design on results, data reported in groups which ignore individual variation, non-standard observer-dependent interpretation of a balance of efficacy and toxicity, and distortion of a "placebo effect." Limitations are seen in many clinical trials of methotrexate (MTX) in rheumatoid arthritis (RA) and psoriatic arthritis (PsA). The first MTX clinical trial in rheumatology documented excellent efficacy in PsA, but frequent adverse events in 1964, explained by intravenous doses up to 150 kg. MTX was abandoned until the 1980s for RA, while gold salts and penicillamine were termed "remission-inducing," on the basis limitations of clinical trials. In the most recent MTX in PsA (MIPA) trial, all outcomes favoured MTX, but only patient and physician global estimates met the pclinical trials than from limitations of MTX.

  14. American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials

    NARCIS (Netherlands)

    Felson, D.T.; Smolen, J.S.; Wells, G.; Zhang, B.; van Tuyl, L.H.D.; Funovits, J.; Aletaha, D.; Allaart, C.F.; Bathon, J.; Bombardieri, S.; Brooks, P.; Brown, A.; Matucci-Cerinic, M.; Choi, H.; Combe, B.; de Wit, M.; Dougados, M.; Emery, P.; Furst, D.; Gomez-Reino, J.; Hawker, G.; Keystone, E.; Khanna, D.; Kirwan, J.; Kvien, T.K.; Landewé, R.; Listing, J.; Michaud, K.; Martin-Mola, E.; Montie, P.; Pincus, T.; Richards, P.; Siegel, J.N.; Simon, L.S.; Sokka, T.; Strand, V.; Tugwell, P.; Tyndall, A.; van der Heijde, D.; Verstappen, S.; White, B.; Wolfe, F.; Zink, A.; Boers, M.

    2011-01-01

    Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. A committee

  15. From inhibition of radiographic progression to maintaining structural integrity: a methodological framework for radiographic progression in rheumatoid arthritis and psoriatic arthritis clinical trials.

    Science.gov (United States)

    Landewé, Robert; Strand, Vibeke; van der Heijde, Désirée

    2013-07-01

    Usually, a clinical trial in rheumatoid arthritis and psoriatic arthritis aiming to demonstrate that a new antirheumatic drug treatment can inhibit progression of structural damage has a 'superiority design': The new treatment is compared to placebo or to another active treatment. Currently, many new drug treatments have shown to be able to completely suppress progression (progression rates close to zero). For largely unknown reasons, during the last 10 years, radiographic progression rates in clinical trials have gradually decreased, so that progression rates in the comparator groups are often too low to demonstrate meaningful inhibition, and thus superiority of the new treatment. We here propose an alternative framework to demonstrate that new treatments have the ability to 'preserve structural integrity' rather than to 'inhibit radiographic progression'. Anno 2013, preserving structural integrity is conceptually more realistic than inhibiting radiographic progression.

  16. Effects of aerobic exercise on hematologic indices of women with rheumatoid arthritis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Yaser Jafari Shapoorabadi

    2016-01-01

    Full Text Available Background: To investigate the effects of moderate aerobic exercise on the hemoglobin, hematocrit, and red blood cell (RBC mass of women with rheumatoid arthritis (RA. Materials and Methods: This randomized clinical trial was conducted at the Specialized Clinic of Physical Medicine and Rehabilitation, Al-Zahra Hospital of Isfahan, during a 4-month period in 2014. We included patients with RA who did not have any malignancy and hematologic disorder. Two groups - one group receiving aerobic therapy along with medical therapy (N = 16 and the other group receiving medical therapy alone (N = 17 both for a period of 8 weeks. The levels of RBC mass, Hb, and HCT were measured before and after the intervention. The changes in these parameters were compared between the two study groups. Results: There was no significant difference between the two study groups regarding the baseline characteristics. The aerobic exercise resulted in increased RBC mass (P < 0.001, Hb (P < 0.001, and HCT (P < 0.001. However, those who received medical therapy alone did not experience any significant changes in these parameters. We found that the RBC mass (P = 0.581, Hb (P = 0.882, and HCT (P = 0.471 were comparable between the two study groups after 8 weeks of intervention. Conclusion: Although the aerobic exercise results in increased Hb, HCT, and RBC mass in patients with RA, the increase was not significant when compared to that in controls. Thus, the increase in the HB, HCT, and RBC could not be attributable to aerobic exercise.

  17. Ethical and practical issues in conducting clinical trials in psoriasis and psoriatic arthritis.

    Science.gov (United States)

    Kavanaugh, A

    2005-03-01

    Ethical considerations are inexorably intertwined with the conduct of clinical research. As a result of progress in immunology and biotechnology, several potent novel therapeutics have recently emerged for the treatment of patients with various immunologically driven systemic inflammatory conditions, including psoriasis and psoriatic arthritis. Because of these developments, there is a need to continually assess the design of current and future research studies so that they may be conducted in the optimal and most ethical manner.

  18. [Caprine arthritis-encephalitis: trial of an adjuvant vaccine preparation. I. Clinical and virological study].

    Science.gov (United States)

    Russo, P; Vitu, C; Fontaine, J J; Vignoni, M

    1993-04-01

    In purpose to protect goats against caprine arthritis encephalitis virus (CAEV), the first group of kids (I) was inoculated with purified, inactivated and adjuvant-treated virions, the second group (II) with adjuvant and the third one (III) with culture medium. 2-4 months later, the three groups were challenged with virulent CAEV by intraarticular route. On the clinical level, vaccinated and challenged kids show more early and severe arthritis than other groups. On the virological level, isolation of lentivirus from white blood cells and different organs is more important in group I than groups II and III. Therefore, vaccinations with inactivated and adjuvant-treated virions do not protect against a virulent challenge; there is an enhancement of lesions. We note that the adjuvant elicits a mild non-specific protection against virulent challenge.

  19. Efficacy of prednisone 1–4 mg/day in patients with rheumatoid arthritis: a randomised, double-blind, placebo controlled withdrawal clinical trial

    OpenAIRE

    2008-01-01

    Objective: A randomised double-blind placebo controlled withdrawal clinical trial of prednisone versus placebo in patients with rheumatoid arthritis (RA), treated in usual clinical care with 1–4 mg/day prednisone, withdrawn to the same dose of 1 mg prednisone or identical placebo tablets. Methods: All patients were from one academic setting and all trial visits were conducted in usual clinical care. Patients were taking stable doses of 1–4 mg prednisone with stable clinical status, documented...

  20. Brief Report: Clinical Trials Aiming to Prevent Rheumatoid Arthritis Cannot Detect Prevention Without Adequate Risk Stratification: A Trial of Methotrexate Versus Placebo in Undifferentiated Arthritis as an Example.

    Science.gov (United States)

    Burgers, Leonie E; Allaart, Cornelia F; Huizinga, Tom W J; van der Helm-van Mil, Annette H M

    2017-05-01

    Prevention of rheumatoid arthritis (RA) was the aim of several trials in undifferentiated arthritis (UA), with overall negative results. As preparatory work has revealed that only ∼30% of UA patients progress to having RA, we hypothesized that inclusion of patients without imminent RA could lead to false-negative results. We undertook this study to evaluate this hypothesis by reinvestigating the Probable Rheumatoid Arthritis: Methotrexate versus Placebo Treatment (PROMPT) trial (a 1-year course of methotrexate [MTX] versus placebo in UA) after excluding patients without a high risk of developing RA. A validated prediction model was used to determine the risk of RA in all patients included in the PROMPT trial. Patients with a prediction score of ≥8 (positive predictive value of ≥84% for developing RA) were considered to have a high risk of developing RA. The effect of a 1-year course of MTX during 5 years of follow-up was reinvestigated in these patients. Twenty-two of the 110 patients in the PROMPT trial had a high risk of RA at baseline. In the MTX arm, 6 of 11 patients (55%) developed RA, compared to 11 of 11 patients (100%) in the placebo arm (P = 0.011). Time to RA development was longer in the MTX arm than in the placebo arm (median 22.5 months versus 3 months; P < 0.001). Drug-free remission was achieved by 4 of 11 patients (36%) in the MTX arm compared to 0 of 11 patients (0%) in the placebo arm (P = 0.031). These beneficial effects of MTX were observed both in anti-citrullinated protein antibody (ACPA)-positive and in ACPA-negative UA patients with a high risk of RA, but not in UA patients without a high risk of RA. In retrospect, 43 of 110 patients fulfilled the American College of Rheumatology/European League Against Rheumatism 2010 classification criteria for RA at baseline. In addition, beneficial effects were observed only in patients with a high prediction score. A 1-year course of MTX delayed and prevented RA development in high

  1. [Arthritis and clinical history].

    Science.gov (United States)

    Silva, Lígia; Sampaio, Luzia; Pinto, José; Ventura, Francisco S

    2011-01-01

    In front of a patient with arthritis, clinical good-sense tells that the most probable diagnosis are the most prevalent ones. Nevertheless, we have to exclude a multiplicity of other aetiologies, less frequent, but with highest implications in the therapeutic conduct. Infections by Brucella and by Borrelia are rare causes of chronic arthritis, yet are diagnosis to consider, even when the clinical manifestations aren't the most typical, as there still exist endemic areas in Portugal. Here we report two clinical cases about patients with arthritis for more than one year, subject to ineffective exams ant treatments. Only the clinical history could put on evidence clinical-epidemiological data, suggestive of Brucellosis and Lyme Disease, namely the professional contact with infected animals, and the history of probable erythema migrans, that pointed toward the correct diagnosis. So, with directed therapeutic, there was complete resolution of the inflammatory symptoms.

  2. Effects of cold mist shower on patients with inflammatory arthritis: a crossover controlled clinical trial.

    Science.gov (United States)

    Hinkka, H; Väättänen, S; Ala-Peijari, S; Nummi, T

    2017-05-01

    To evaluate the safety and effects of a new home treatment method, a whole-body cold mist treatment, on patients with chronic inflammatory arthritis. Whole-body cold mist shower therapy was given to 121 voluntary patients with chronic inflammatory arthritis in this crossover study during 1-week rehabilitation periods. Pain and sleep quality were assessed by a 10-cm visual analogue scale (VAS). Mental status was assessed by the Depression Scale (DEPS). Body temperature, blood pressure, heart rate, use of occasional pain and sleep medication, and possible side-effects were recorded. The differences in pain (VAS) between treatment and control periods were significant (2.0 vs. 2.4, p = 0.006, paired t-test) in the last measurement, when assessing the pain of the past week as a whole. A trend could be seen of an increasing difference towards the end of the week. The treatment effect was statistically significant [likelihood ratio test (LRT), p cold treatment method may offer a safe option for self-treatment of pain at home but further study is needed to determine the clinical significance of the effect after longer use.

  3. Comparison of 2 dosages of intraarticular triamcinolone for the treatment of knee arthritis: results of a 12-week randomized controlled clinical trial

    NARCIS (Netherlands)

    Popma, J.W.; Snel, Frank W.; Haagsma, Cees J.; Brummelhuis-Visser, Petra; Oldenhof, Hans G.J.; van der Palen, Jacobus Adrianus Maria; van de Laar, Mart A F J

    2015-01-01

    Objective. To determine whether a double dose of intraarticular triamcinolone acetonide is more effective for knee arthritis than a 40-mg dose. Methods. In this 12-week randomized controlled clinical trial, 40 mg and 80 mg of intraarticular triamcinolone acetonide were compared in patients with knee

  4. Selecting magnetic resonance imaging (MRI) outcome measures for juvenile idiopathic arthritis (JIA) clinical trials: first report of the MRI in JIA special interest group.

    Science.gov (United States)

    Hemke, Robert; Doria, Andrea S; Tzaribachev, Nikolay; Maas, Mario; van der Heijde, Désirée M F M; van Rossum, Marion A J

    2014-02-01

    Recent advances in magnetic resonance imaging (MRI) techniques have substantially improved the evaluation of joint pathologies in juvenile idiopathic arthritis (JIA). Because of the current availability of highly effective antirheumatic therapies and the unique and useful features of MRI, there is a growing need for an accurate and reproducible MRI assessment scoring system for JIA, such as the rheumatoid arthritis MRI Scoring (RAMRIS) for patients with rheumatoid arthritis (RA). To effectively evaluate the efficacy of treatment in clinical research trials, we need to develop and validate scoring methods to accurately measure joint outcomes, standardize imaging protocols for data acquisition and interpretation, and create imaging atlases to differentiate physiologic and pathologic joint findings in childhood and adolescence. Such a standardized, validated, JIA-MRI scoring method could be used as an outcome measure in clinical trials.

  5. American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials

    Science.gov (United States)

    Felson, David T.; Smolen, Josef S.; Wells, George; Zhang, Bin; van Tuyl, Lilian H. D.; Funovits, Julia; Aletaha, Daniel; Allaart, Renée; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Dan; Gomez-Reino, Juan; Hawker , Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Mola, Emilio Martin; Montie, Pam; Pincus, Ted; Richards, Pam; Siegel, Jeff; Simon, Lee; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Fred; Zink, Angela; Boers, Maarten

    2010-01-01

    Background With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials. Methods A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient reported outcomes and the ability of candidate measures to predict later good x-ray and functional outcomes. Results Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the

  6. Effects of intensive exercise on patients with active rheumatoid arthritis: a randomised clinical trial.

    NARCIS (Netherlands)

    Ende, C.H.M. van den; Breedveld, F.C.; Cessie, S. le; Dijkmans, B.A.C.; Mug, A.W. de

    2000-01-01

    Objectives: To investigate the effects of a dynamic, intensive exercise regimen on pain, disease activity, and physical functioning in active rheumatoid arthritis (RA). Methods: 64 patients with RA with a mean age of 60 (13) years and mean disease duration of 8 (8) years, admitted to hospital becaus

  7. CCR5 blockade in rheumatoid arthritis: a randomised, double-blind, placebo-controlled clinical trial

    NARCIS (Netherlands)

    A.W.R. van Kuijk; C.E. Vergunst; D.M. Gerlag; B. Bresnihan; J.J. Gomez-Reino; R. Regine; P.C. Verschueren; C. van der Leij; M. Maas; M.C. Kraan; P.P. Tak

    2010-01-01

    Objective C-C chemokine receptor type 5 (CCR5), a chemokine receptor expressed on T cells and macrophages, and its ligands are found in inflamed synovial tissue (ST) of patients with rheumatoid arthritis (RA). The rationale for testing CCR5 blockade in patients with RA was supported by the effects o

  8. Evaluation of the Anti-inflammatory Effects of Atorvastatin on Patients with Rheumatoid Arthritis: A Randomized Clinical Trial

    Science.gov (United States)

    Sarabi, Zhaleh Shariati; Saeidi, Mehran Ghazi; Khodashahi, Mandana; Rezaie, Ali Etemad; Hashemzadeh, Kamila; Khodashahi, Rozita; Heidari, Hossein

    2016-01-01

    Background Rheumatoid arthritis (RA) is a chronic inflammatory joint disorder with unknown etiology. Atorvastatin is a lipid-lowering agent that affects the inflammatory processes. Objective This study aimed to determine the anti-inflammatory effects of atorvastatin on the Disease Activity Index and high-density lipoprotein (HDL) concentrations in RA patients. Methods This clinical trial was performed on 38 RA patients, who were referred to the Imam Reza and Ghaem Medical Centers of Mashhad, Iran between 2013 and 2014. Patients were divided into two groups: 1) the intervention group, which received 40 mg of atorvastatin, and 2) the control group. Response to treatment and the clinical status of patients were evaluated using the Disease Activity Score (DAS-28) and Visual Analogue Scale (VAS) at weeks zero, four, eight, and twelve, based on the 2010 ACR/EULAR Criteria by two rheumatologists. Disease activity and laboratory parameters, including erythrocyte sedimentation rate (ESR), high-sensitivity C-reactive protein (hs-CRP), DAS-ESR, DAS- hs-CRP, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and liver function test (LFT) were measured in both groups. Results There was a significant difference in the mean number of swollen joints (p<0.011), ESR (p <0.005), DAS-ESR (P<0.043), LDL (0.036), and HDL (0.016) between the two groups. The changes in trend showed no significant difference in the mean number of tender joints (p =0.38), VAS (p =0.715), CRP (p =0.07), DAS-hs-CRP (p=0.431), total cholesterol (p=0.285), or TG (p =0.331) between the two groups. However, the Disease Activity Index decreased by 48.4% in the intervention group, compared to 35.5% in the control group. Conclusion As the results indicated, atorvastatin has a positive effect on the course of RA. In fact, atorvastatin, as an anti-inflammatory agent, could significantly influence inflammation in RA patients. Therefore, adding a lipid-lowering agent to standard medications in RA may be

  9. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  10. Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

    Science.gov (United States)

    Daily, James W; Yang, Mini; Park, Sunmin

    2016-08-01

    Although turmeric and its curcumin-enriched extracts have been used for treating arthritis, no systematic review and meta-analysis of randomized clinical trials (RCTs) have been conducted to evaluate the strength of the research. We systemically evaluated all RCTs of turmeric extracts and curcumin for treating arthritis symptoms to elucidate the efficacy of curcuma for alleviating the symptoms of arthritis. Literature searches were conducted using 12 electronic databases, including PubMed, Embase, Cochrane Library, Korean databases, Chinese medical databases, and Indian scientific database. Search terms used were "turmeric," "curcuma," "curcumin," "arthritis," and "osteoarthritis." A pain visual analogue score (PVAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were used for the major outcomes of arthritis. Initial searches yielded 29 articles, of which 8 met specific selection criteria. Three among the included RCTs reported reduction of PVAS (mean difference: -2.04 [-2.85, -1.24]) with turmeric/curcumin in comparison with placebo (P turmeric/curcumin treatment (mean difference: -15.36 [-26.9, -3.77]; P = .009). Furthermore, there was no significant mean difference in PVAS between turmeric/curcumin and pain medicine in meta-analysis of five studies. Eight RCTs included in the review exhibited low to moderate risk of bias. There was no publication bias in the meta-analysis. In conclusion, these RCTs provide scientific evidence that supports the efficacy of turmeric extract (about 1000 mg/day of curcumin) in the treatment of arthritis. However, the total number of RCTs included in the analysis, the total sample size, and the methodological quality of the primary studies were not sufficient to draw definitive conclusions. Thus, more rigorous and larger studies are needed to confirm the therapeutic efficacy of turmeric for arthritis.

  11. Effects of probiotic supplementation on lipid profile of women with rheumatoid arthritis: A randomized placebo-controlled clinical trial

    Science.gov (United States)

    Vaghef-Mehrabany, Elnaz; Vaghef-Mehrabany, Leila; Asghari-Jafarabadi, Mohammad; Homayouni-Rad, Aziz; Issazadeh, Karim; Alipour, Beitullah

    2017-01-01

    Background: Probiotics are live beneficial microorganisms which may exert hypolipidemic effects through many mechanisms. Lipid profile disturbances are frequently reported in rheumatoid arthritis (RA) patients. The objective of this study was to evaluate the effects of Lactobacillus casei on serum lipids of RA women. Methods: In the present parallel randomized double-blind placebo-controlled clinical trial, 60 RA patients were recruited and divided into 2 groups. They received either a daily capsule containing 108 CFU of L. casei 01, or identical capsules containing maltodextrin, for 8 weeks. Anthropometric parameters, dietary intake and physical activity were assessed at 2 ends of the study. Serum levels of total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C) and triglyceride (TG) were measured. Independent-samples t test and analysis of covariance (ANCOVA) test, and paired t test were used to test between- and within-group differences, respectively. Results: There were no significant between- or within-group differences for demographic and anthropometric parameters, physical activity and dietary intakes, throughout the study. No statistically significant within-group changes were observed for serum lipids in either group; between-group differences were also insignificant by the end of study period (TC: -0.18 [-0.65, 0.29], P = 0.801, HDL-C: -1.66 [-19.28, 15.59], P = 0.663, LDL-C: -2.73 [-19.17, 13.73], P = 0.666, TG: 0.12 [-19.76, 20.00], P = 0.900). Conclusion: Lactobacillus casei 01 could not improve serum lipids in RA patients. Further studies using probiotic foods and different probiotic strains are suggested.

  12. THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA® IN RHEUMATOID ARTHRITIS (THE BIORA STUDY

    Directory of Open Access Journals (Sweden)

    E. L. Nasonov

    2016-01-01

    Full Text Available The article considers the results of an international multicenter randomized clinical trial of the efficacy and safety of the brand-name drug rituximab (MabThera, a monoclonal antibody against CD20 antigen of B cells, and its biosimi-lar drug (Acellbia® (the BIORA study in patients with rheumatoid arthritis (RA refractory to therapy with tumor necrosis factor-а inhibitors.Objective: to provide evidence for the therapeutic equivalence of Acellbia® and MabThera® and also to assess their interchangeability.Subjects and methods. The trial enrolled adult patients with active seropositive RA, who were randomized into two groups (1:1: 1 the patients who received Acellbia® 1000 mg intravenously on days 1 and 15; 2 those who had MabThera® in a similar way. When RA activity persisted at 24 weeks, there was re-randomization (1:1 with a partial overlap: Group 1 patients were randomized into group AA (the drug of the second therapy cycle was Acellbia® or Group AM (that was MabThera®, the similar methodology was followed in Group 2 (Groups MM and MA. Throughout the study, the patients received methotrexate at a stable dose of 7.5—25 mg/week and folic acid at a dose of 5 mg/week. The follow-up lasted 48 weeks.Results and discussion. 24 weeks after treatment initiation, the ACR20 response was observed in 84.1% of the patients in the Acellbia® group (95% CI, 74.75—90.50 and in 87% in the MabThera® group (95% CI, 77.71—92.79%; p = 0.773, which suggests that the drugs are therapeutically equivalent. In the second phase of the study, the efficiency of therapy remained high; there were no differences in Groups AA/MM, AA/AM and MM/MA. In both phases, the safety profile of the drugs was comparable; the immunogenicity of treatment remained low. The findings suggest that the brand-name MabThera® and its biosimilar drug Acellbia® are equivalent. Switching from the biosimilar drug to the brand-name one and vice versa has no negative impact on treatment

  13. Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial

    Science.gov (United States)

    2013-01-01

    Background Rheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA. Methods/design The ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group. The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health

  14. Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial.

    Science.gov (United States)

    Monsarrat, Paul; Vergnes, Jean-Noël; Cantagrel, Alain; Algans, Nadège; Cousty, Sarah; Kémoun, Philippe; Bertrand, Caroline; Arrivé, Elise; Bou, Christophe; Sédarat, Cyril; Schaeverbeke, Thierry; Nabet, Cathy; Sixou, Michel

    2013-08-14

    Rheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA. The ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group.The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health Assessment Questionnaire and the

  15. Leflunomide, a new disease-modifying drug for treating active rheumatoid arthritis in methotrexate-controlled phase Ⅱ clinical trial

    Institute of Scientific and Technical Information of China (English)

    鲍春德; 陈顺乐; 顾越英; 劳志英; 倪立青; 於强; 徐建华; 李向培; 刘嘉玲; 孙凌云; 何培根; 马骥良; 徐淑云; 丁长海

    2003-01-01

    Objective To evaluate the efficacy and safety of leflunomide in comparison with methotrexate (MTX) on patients with rheumatoid arthritis (RA) in China.Methods Five hundred and sixty-six patients with active rheumatoid arthritis were randomly assigned to receive leflunomide at 20 mg once daily or MTX at 15 mg once weekly in a controlled trial. Five hundred and four patients completed the 12-week treatment and some patients continued the treatment for 24 weeks.Results Both leflunomide and MTX could improve the symptoms, signs, and joint function, but there were no changes in X-ray observations of patients with rheumatoid arthritis. In the leflunomide group, the overall rates of effectiveness at 12 weeks and 24 weeks were 86.94% and 92.31% respectively; the rates of remarkable improvement were 64.95% and 79.81% respectively. In the MTX group, the overall rates of effectiveness at 12 weeks and 24 weeks were 84.04% and 83.15% respectively; the rates of remarkable improvement were 56.81% and 75.28% respectively. According to intent-to-treat analysis, the ACR 20% response rates at 12 weeks and 24 weeks in the leflunomide group were 62.54% and 67.18% respectively, compared with 60.08% and 61.32% respectively in MTX group. No statistical differences were shown in the efficacy between the two groups (P>0.05). The adverse events in the leflunomide group were gastrointestinal symptoms, skin rash, alopecia, nervous system symptoms, decreased leukocyte count, and elevation of alanine aminotransferase (ALT). Most of these side effects were mild and transient. The incidence of adverse events in the leflunomide group was 16.84%, significantly lower than that in MTX group (28.17%, P=0.002).Conclusions Leflunomide is effective in the treatment of RA with less adverse events than MTX. Its efficacy is similar to MTX, but the incidence of adverse events and the rate of withdrawal due to adverse events were lower in the leflunomide group than in MTX group.

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits ... of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study ...

  17. Testing of the preliminary OMERACT validation criteria for a biomarker to be regarded as reflecting structural damage endpoints in rheumatoid arthritis clinical trials: the example of C-reactive protein

    DEFF Research Database (Denmark)

    Keeling, Stephanie O; Landewe, Robert; van der Heijde, Desiree;

    2007-01-01

    OBJECTIVE: A list of 14 criteria for guiding the validation of a soluble biomarker as reflecting structural damage endpoints in rheumatoid arthritis (RA) clinical trials was drafted by an international working group after a Delphi consensus exercise. C-reactive protein (CRP), a soluble biomarker...

  18. A randomised trial of differentiated prednisolone treatment in active rheumatoid arthritis. Clinical benefits and skeletal side effects

    DEFF Research Database (Denmark)

    Hansen, M; Podenphant, J; Florescu, A

    1999-01-01

    to have a protective effect against bone loss in the hand and distal forearm. CONCLUSIONS: This study does not allow any firm conclusions for or against the treatment of rheumatoid arthritis with prednisolone. The data suggest that the beneficial effects of prednisolone are not as clear cut in established...... rheumatoid arthritis as in early disease. Furthermore the data indicate that treatment in the chosen relatively low dose does not provide sufficient control of disease. On the other hand the spinal bone loss observed in the prednisolone group does invite considerations about using higher doses.......OBJECTIVES: To study benefits and skeletal side effects of carefully monitored prednisolone treatment in patients with active rheumatoid arthritis. METHODS: One hundred and two patients with active rheumatoid arthritis were randomly allocated to treatment with disease modifying anti...

  19. What Are Clinical Trials?

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials What Are Clinical Trials? Past Issues / Fall 2010 Table of Contents Clinical ... conducted all the time. The Different Phases of Clinical Trials Clinical trials related to drugs are classified into ...

  20. Participating in Clinical Trials

    Science.gov (United States)

    ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  1. Prospective Clinical Trial for Septic Arthritis: Cartilage Degradation and Inflammation Are Associated with Upregulation of Cartilage Metabolites

    Directory of Open Access Journals (Sweden)

    Hagen Schmal

    2016-01-01

    Full Text Available Background. Intra-articular infections can rapidly lead to osteoarthritic degradation. The aim of this clinical biomarker analysis was to investigate the influence of inflammation on cartilage destruction and metabolism. Methods. Patients with acute joint infections were enrolled in a prospective clinical trial and the cytokine composition of effusions (n=76 was analyzed. Characteristics of epidemiology and disease severity were correlated with levels of cytokines with known roles in cartilage turnover and degradation. Results. Higher synovial IL-1β concentrations were associated with clinical parameters indicating a higher disease severity (p<0.03 excluding the incidence of sepsis. Additionally, intra-articular IL-1β levels correlated with inflammatory serum parameters as leucocyte counts (LC and C-reactive protein concentrations (p<0.05 but not with age or comorbidity. Both higher LC and synovial IL-1β levels were associated with increased intra-articular collagen type II cleavage products (C2C indicating cartilage degradation. Joints with preinfectious lesions had higher C2C levels. Intra-articular inflammation led to increased concentrations of typical cartilage metabolites as bFGF, BMP-2, and BMP-7. Infections with Staphylococcus species induced higher IL-1β expression but less cartilage destruction than other bacteria. Conclusion. Articular infections have bacteria-specific implications on cartilage metabolism. Collagen type II cleavage products reliably mark destruction, which is associated with upregulation of typical cartilage turnover cytokines. This trial is registered with DRKS00003536, MISSinG.

  2. Testing of the preliminary OMERACT validation criteria for a biomarker to be regarded as reflecting structural damage endpoints in rheumatoid arthritis clinical trials: the example of C-reactive protein

    DEFF Research Database (Denmark)

    Keeling, Stephanie O; Landewe, Robert; van der Heijde, Desiree

    2007-01-01

    OBJECTIVE: A list of 14 criteria for guiding the validation of a soluble biomarker as reflecting structural damage endpoints in rheumatoid arthritis (RA) clinical trials was drafted by an international working group after a Delphi consensus exercise. C-reactive protein (CRP), a soluble biomarker......-based survey. RESULTS: Minimal data were extracted from the literature pertaining to those criteria listed under the category of truth. Ratings for strength of evidence were moderate to low (

  3. Effects of probiotic supplementation on lipid profile of women with rheumatoid arthritis: A randomized placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Elnaz Vaghef-Mehrabany

    2017-03-01

    lipids of RA women. Methods: In the present parallel randomized double-blind placebo-controlled clinical trial, 60 RA patients were recruited and divided into 2 groups. They received either a daily capsule containing 108 CFU of L. casei 01, or identical capsules containing maltodextrin, for 8 weeks. Anthropometric parameters, dietary intake and physical activity were assessed at 2 ends of the study. Serum levels of total cholesterol (TC, high-density lipoprotein-cholesterol (HDL-C, low-density lipoprotein-cholesterol (LDL-C and triglyceride (TG were measured. Independent-samples t test and analysis of covariance (ANCOVA test, and paired t test were used to test between- and within-group differences, respectively. Results: There were no significant between- or within-group differences for demographic and anthropometric parameters, physical activity and dietary intakes, throughout the study. No statistically significant within-group changes were observed for serum lipids in either group; between-group differences were also insignificant by the end of study period (TC: -0.18 [-0.65, 0.29], P = 0.801, HDL-C: -1.66 [-19.28, 15.59], P = 0.663, LDL-C: -2.73 [-19.17, 13.73], P = 0.666, TG: 0.12 [-19.76, 20.00], P = 0.900. Conclusion: Lactobacillus casei 01 could not improve serum lipids in RA patients. Further studies using probiotic foods and different probiotic strains are suggested.

  4. Types of Treatment: Clinical Trials

    Science.gov (United States)

    ... Disease Information Treatment Types of Treatment Clinical Trials Clinical Trials Clinical Trials SHARE: Print Glossary Taking part in a clinical ... for cancer are based on previous clinical trials. Clinical Trial Service: LLS provides personalized clinical trial navigation when ...

  5. Clinical management of septic arthritis.

    Science.gov (United States)

    Sharff, Katie A; Richards, Eric P; Townes, John M

    2013-06-01

    Septic arthritis is a rheumatologic emergency as joint destruction occurs rapidly and can lead to significant morbidity and mortality. Accurate diagnosis can be particularly challenging in patients with underlying inflammatory joint disease. This review outlines the risk factors for septic arthritis and summarizes the causative bacterial organisms. We highlight advances in antibiotic management with a focus on new drugs for methicillin-resistant Staphylococcus aureus (MRSA) and discuss the use of adjunctive therapies for treatment of septic arthritis in adults.

  6. The effects of written emotional disclosure and coping skills training in rheumatoid arthritis: a randomized clinical trial.

    Science.gov (United States)

    Lumley, Mark A; Keefe, Francis J; Mosley-Williams, Angelia; Rice, John R; McKee, Daphne; Waters, Sandra J; Partridge, R Ty; Carty, Jennifer N; Coltri, Ainoa M; Kalaj, Anita; Cohen, Jay L; Neely, Lynn C; Pahssen, Jennifer K; Connelly, Mark A; Bouaziz, Yelena B; Riordan, Paul A

    2014-08-01

    Two psychological interventions for rheumatoid arthritis (RA) are cognitive-behavioral coping skills training (CST) and written emotional disclosure (WED). These approaches have developed independently, and their combination may be more effective than either one alone. Furthermore, most studies of each intervention have methodological limitations, and each needs further testing. We randomized 264 adults with RA in a 2 × 2 factorial design to 1 of 2 writing conditions (WED vs. control writing) followed by 1 of 2 training conditions (CST vs. arthritis education control training). Patient-reported pain and functioning, blinded evaluations of disease activity and walking speed, and an inflammatory marker (C-reactive protein) were assessed at baseline and 1-, 4-, and 12-month follow-ups. Completion of each intervention was high (>90% of patients), and attrition was low (10.2% at 12-month follow-up). Hierarchical linear modeling of treatment effects over the follow-up period, and analyses of covariance at each assessment point, revealed no interactions between writing and training; however, both interventions had main effects on outcomes, with small effect sizes. Compared with control training, CST decreased pain and psychological symptoms through 12 months. The effects of WED were mixed: Compared with control writing, WED reduced disease activity and physical disability at 1 month only, but WED had more pain than control writing on 1 of 2 measures at 4 and 12 months. The combination of WED and CST does not improve outcomes, perhaps because each intervention has unique effects at different time points. CST improves health status in RA and is recommended for patients, whereas WED has limited benefits and needs strengthening or better targeting to appropriate patients. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  7. The AMBITION trial: tocilizumab monotherapy for rheumatoid arthritis.

    Science.gov (United States)

    Jones, Graeme

    2010-03-01

    Recent years have seen many exciting developments in the treatment of inflammatory arthritis. Tocilizumab (TCZ) is a compound that inhibits the IL-6 receptor. Following initial studies in Japan, it has been extensively studied in five multicenter clinical trials. This report concentrates on the Actemra Versus Methotrexate Double-blind Investigative Trial in Monotherapy (AMBITION), which compared TCZ monotherapy (8 mg/kg every 4 weeks) with methotrexate monotherapy over 24 weeks. TCZ was shown to be the first biologic agent that is superior to methotrexate across a whole range of clinical outcomes measures with a rapid onset of effect. Significant liver toxicity was less common in the TCZ group. However, increases in lipids and decreases in neutrophils and skin infections were more common in the TCZ arm. Long-term efficacy and safety follow-up is ongoing. This trial supports the use of TCZ as monotherapy and suggests it should be regarded as a first-line biologic therapy.

  8. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... NICHD Publications Data Sharing and Other Resources Research Clinical Trials & Clinical Research Skip sharing on social media links ... health care providers, and researchers. Find NICHD-Supported Clinical Trials Use this link to find a list of ...

  9. Synovial tissue sublining CD68 expression is a biomarker of therapeutic response in rheumatoid arthritis clinical trials: consistency across centers.

    LENUS (Irish Health Repository)

    Bresnihan, Barry

    2012-02-01

    OBJECTIVE: To determine whether the correlation between the mean change in disease activity and the mean change in synovial sublining (sl) CD68 expression could be demonstrated across different academic centers. METHODS: Synovial biopsies obtained at arthroscopy from patients with rheumatoid arthritis before and 160 days after rituximab therapy were selected and coded. Paired sections were processed independently at Amsterdam Medical Center (AMC) and at St. Vincent\\'s University Hospital (SVUH), Dublin. Digital image analysis (DIA) was employed at both centers to quantify sublining CD68 expression. RESULTS: After analysis of CD68sl expression at centers in 2 different countries, high levels of intracenter and intercenter agreement were observed. For the pooled sections stained at AMC, the correlation between 2 investigators was R = 0.942, p = 0.000, and for sections stained at SVUH, R = 0.899, p = 0.001. Similarly, the intracenter correlations for DeltaCD68sl expression after treatment were R = 0.998, p = 0.000, for sections stained at AMC and R = 0.880, p = 0.000, for sections stained at SVUH. The intercenter correlation for the pooled scores of sections stained at AMC was R = 0.85, p = 0.000, and for the sections stained at SVUH, R = 0.62, p = 0.001. The consistent correlation between DeltaDAS (Disease Activity Score) and DeltaCD68sl expression across different studies (Pearson correlation = 0.895, p < 0.001) was confirmed. The standardized response mean values for DeltaCD68sl, calculated from analyses at both AMC and SVUH, were consistently 0.5 or greater, indicating a moderate to high potential to detect change. CONCLUSION: The correlation between mean DeltaDAS and mean DeltaCD68sl expression was confirmed across 2 centers. Examination of serial biopsy samples can be used reliably to screen for interesting biological effects at the site of inflammation at an early stage of drug development.

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will ... disease. Phases of Clinical Trials Clinical trials of drugs are usually described based on their phase. The ...

  11. Marine Oil Supplements for Arthritis Pain: A Systematic Review and Meta-Analysis of Randomized Trials

    Directory of Open Access Journals (Sweden)

    Ninna K. Senftleber

    2017-01-01

    Full Text Available Arthritis patients often take fish oil supplements to alleviate symptoms, but limited evidence exists regarding their efficacy. The objective was to evaluate whether marine oil supplements reduce pain and/or improve other clinical outcomes in patients with arthritis. Six databases were searched systematically (24 February 2015. We included randomized trials of oral supplements of all marine oils compared with a control in arthritis patients. The internal validity was assessed using the Cochrane Risk of Bias tool and heterogeneity was explored using restricted maximum of likelihood (REML-based meta-regression analysis. Grading of Recommendations Assessment, Development and Evaluation (GRADE was used to rate the overall quality of the evidence. Forty-two trials were included; 30 trials reported complete data on pain. The standardized mean difference (SMD suggested a favorable effect (−0.24; 95% confidence interval, CI, −0.42 to −0.07; heterogeneity, I2 = 63%. A significant effect was found in patients with rheumatoid arthritis (22 trials; −0.21; 95% CI, −0.42 to −0.004 and other or mixed diagnoses (3 trials; −0.63; 95% CI, −1.20 to −0.06, but not in osteoarthritis patients (5 trials; −0.17; 95% CI, −0.57–0.24. The evidence for using marine oil to alleviate pain in arthritis patients was overall of low quality, but of moderate quality in rheumatoid arthritis patients.

  12. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Eye Health Information > Clinical Trials in Vision Research Clinical Trials in Vision Research Clinical studies depend on people ... vision research in the United States. Basics of Clinical Trials What is a clinical trial? Clinical trials are ...

  13. Clinical management of septic arthritis in cattle.

    Science.gov (United States)

    Desrochers, André; Francoz, David

    2014-03-01

    Synovial fluid, ultrasound, and radiographic imaging are common diagnostic tools for septic arthritis. Mycoplasma septic arthritis is suspected in calves with clinical signs of otitis and pneumonia. Commonly affected joints are carpus, stifle, and tarsus. Treatment strategy must include long-term antibiotics, anti-inflammatories, and joint lavage. Knowledge of communication and boundaries for commonly affected joints is essential to perform joint lavage and arthrotomy.

  14. Clinical Trials

    Science.gov (United States)

    ... and her initial results. Nueva Esperanza Para Las Enfermedades Del Corazón 09/23/2014 Milena tuvo un ... Story 09/23/2014 Nueva Esperanza Para Las Enfermedades Del Corazón 09/23/2014 Children and Clinical ...

  15. An open randomized active-controlled clinical trial with low-dose SKA cytokines versus DMARDs evaluating low disease activity maintenance in patients with rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Martin-Martin LS

    2017-03-01

    Full Text Available LS Martin-Martin,1 F Giovannangeli,2 E Bizzi,2 U Massafra,2 E Ballanti,2 M Cassol,3 A Migliore2 1Department of Internal Medicine, Regina Apostolorum Hospital, 2Operative Unit of Rheumatology, 3Department of Internal Medicine, San Pietro Fatebenefratelli Hospital, Rome, Italy Background: Biologic agents are currently the strongest immunosuppressive drugs able to induce remission in rheumatoid arthritis (RA. One of the objectives of the medical scientific community now is how to maintain remission or low disease activity (LDA. The aim of this trial is to evaluate the contribution of low-dose sequential kinetic activation (SKA IL-4, IL-10, and anti-IL-1 antibodies (10 fg/mL in patients affected by RA in maintaining LDA or remission obtained after biological therapy. Method: This is a randomized, open, active-controlled, prospective, Phase IV trial. Disease activity score (DAS28, clinical disease activity index, simplified disease activity index, erythrocyte sedimentation rate and C-reactive protein levels, global health assessment, and pain visual analog scale were evaluated at baseline visit and then every 3 months together with an assessment of side effects till 12 months. Thirty-nine RA patients were enrolled and randomized to continue disease-modifying antirheumatic drugs (DMARDs therapy or to receive a combination of SKA low-dose cytokines formulated in concentration of 10 fg/mL orally administered at a dose of 20 drops/d for 12 consecutive months. Results: The rate of maintenance of LDA at 12 months was superior in the group treated with low-dose cytokines compared with patients treated with DMARDs, 66.7% and 42.1%, respectively; however, the difference between the groups was not statistically significant. No side effects were reported in both groups. Conclusion: This is the first study using a combination of three low-dose cytokines in RA, after data published on psoriasis. These data suggest that the use of a combination of low-dose SKA

  16. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Studies NHLBI Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical ... protect patients and help produce reliable study results. Clinical Trial Protocol Each clinical trial has a master plan ...

  17. Efficacy and safety of Tofacitinib in patients with active rheumatoid arthritis resistant to conventional therapy: Preliminary results of an open-label clinical trial

    Directory of Open Access Journals (Sweden)

    E. L. Luchikhina

    2016-01-01

    Full Text Available Despite the advances in the therapy of rheumatoid arthritis (RA, which are associated with the use of biological anti-rheumatic drugs, the problemof effective treatment of RA is not still solved. Inclusion of new methods in treatment strategies, in particular the so-called «small molecules», i.e. synthetic compounds acting on intracellular signaling pathways, such as Tofacitinib (TOFA approved for use in rheumatologic practice, is very important.Objective: to evaluate the efficacy and safety of therapy with TOFA in combination with synthetic disease-modifying anti-rheumatic drugs (s-DMARDs, primarily methotrexate (MTX in in patients with active RA in real clinical practice.Subjects and methods. This ongoing open-label trial is a part of the scientific program «Russian Investigation of Methotrexate and Biologics in Early Active Inflammatory Arthritis» (REMARCA that explores the possibility of adapting the «treat-to-target» strategy in real prac-tice in Russia. The study included RA patients with moderate to high disease activity despite treatment with MTX or other DMARDs. A total of 41 patients with RA were included (8 males, 33 females; mean age 52.6±14.2 years, disease duration 47.2±49.7 months, 82.9% RF+ and 80.5% anti-CCP+,DAS28-ESR 5.45±0.95, SDAI 30.2±12.2. All the patients had previously received s-DMARDs; 12 (29.3% patients also had biological DMARDs (1 to 4 biologics. Oral TOFA 5 mg in combination with MTX or leflunomide was administered twice daily to 40 and 1 patients, respectively, with the possibility of increasing the dose up to 10 mg BID. To date, 37 and 12 patients received TOFA for 3 and 6 months, respectively.Results. TOFA was used as a second-line drug (after s-DMARDs failure in 29 (70.7%, as a third line drug (after s-DMARDs and biologics failure in 12 (29.3% patients. The dose was escalated to 10 mg BID in 13 (31.2% patients, on the average, 11.2±1.7 weeks after treatment initiation. TOFA was not

  18. Evaluation of several ultrasonography scoring systems for synovitis and comparison to clinical examination: results from a prospective multicentre study of rheumatoid arthritis

    DEFF Research Database (Denmark)

    Dougados, Maxime; Jousse-Joulin, Sandrine; Mistretta, Frederic

    2010-01-01

    To evaluate different global ultrasonographic (US) synovitis scoring systems as potential outcome measures of rheumatoid arthritis (RA) according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) filter....

  19. Informed Consent (Clinical Trials)

    Science.gov (United States)

    ... Research Cancer Treatment Types of Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...

  20. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  1. ClinicalTrials.gov

    Science.gov (United States)

    ... to This Site Terms and Conditions Disclaimer ClinicalTrials.gov is a registry and results database of publicly ... of human participants conducted around the world. ClinicalTrials.gov is a registry and results database of publicly ...

  2. What Is Juvenile Arthritis?

    Science.gov (United States)

    ... Analgesics for Osteoarthritis (Report from AHRQ) Joint Replacement Surgery: Health Information Basics for You and Your Family NIH Pediatric Rheumatology Clinic Health Information Juvenile Arthritis Find a Clinical Trial Journal Articles Juvenile Arthritis PDF Version Size: 123 KB ...

  3. A nurse-led rheumatology clinic versus rheumatologist-led clinic in monitoring of patients with chronic inflammatory arthritis undergoing biological therapy: a cost comparison study in a randomised controlled trial.

    Science.gov (United States)

    Larsson, Ingrid; Fridlund, Bengt; Arvidsson, Barbro; Teleman, Annika; Svedberg, Petra; Bergman, Stefan

    2015-11-16

    Recommendations for rheumatology nursing management of chronic inflammatory arthritis (CIA) from European League Against Rheumatism (EULAR) states that nurses should take part in the monitoring patients' disease and therapy in order to achieve cost savings. The aim of the study was to compare the costs of rheumatology care between a nurse-led rheumatology clinic (NLC), based on person-centred care (PCC), versus a rheumatologist-led clinic (RLC), in monitoring of patients with CIA undergoing biological therapy. Patients with CIA undergoing biological therapy (n = 107) and a Disease Activity Score of 28 ≤ 3.2 were randomised to follow-up by either NLC or RLC. All patients met the rheumatologist at inclusion and after 12 months. In the intervention one of two annual monitoring visits in an RLC was replaced by a visit to an NLC. The primary outcome was total annual cost of rheumatology care. A total of 97 patients completed the RCT at the 12 month follow-up. Replacing one of the two annual rheumatologist monitoring visits by a nurse-led monitoring visit, resulted in no additional contacts to the rheumatology clinic, but rather a decrease in the use of resources and a reduction of costs. The total annual rheumatology care costs including fixed monitoring, variable monitoring, rehabilitation, specialist consultations, radiography, and pharmacological therapy, generated € 14107.7 per patient in the NLC compared with € 16274.9 in the RCL (p = 0.004), giving a € 2167.2 (13 %) lower annual cost for the NLC. Patients with CIA and low disease activity or in remission undergoing biological therapy can be monitored with a reduced resource use and at a lower annual cost by an NLC, based on PCC with no difference in clinical outcomes. This could free resources for more intensive monitoring of patients early in the disease or patients with high disease activity. The trial is registered as a clinical trial at the ClinicalTrials.gov (NCT01071447). Registration date: October 8

  4. Reappraisal of the clinical use of leflunomide in rheumatoid arthritis and psoriatic arthritis

    Directory of Open Access Journals (Sweden)

    Peter BB Jones

    2010-11-01

    Full Text Available Peter BB Jones1,2, Douglas HN White21Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, 2Rheumatology Department, Waikato Hospital, Hamilton, New ZealandAbstract: Leflunomide is a disease-modifying antirheumatic drug (DMARD that has been in routine clinical use for the treatment of rheumatoid arthritis (RA and psoriatic arthritis for a decade. In RA, clinical trials of up to two years’ duration showed that leflunomide monotherapy was equivalent to methotrexate in clinical and radiographic disease outcomes (tender and swollen joint counts, physician and patient global assessments, American College of Rheumatology and Disease Activity Score responses, slowing or halting of radiographic progression. In a number of studies, quality of life measurements indicated that leflunomide is superior to methotrexate. Leflunomide has been studied in combination with methotrexate and shows efficacy in patients only partly responsive to this agent. Recent trials have shown that leflunomide can be used safely with biologic DMARDs, including antitumor necrosis factor agents and rituximab as part of the treatment algorithm in place of methotrexate as a cotherapy. Leflunomide has demonstrated efficacy as a monotherapy in psoriatic arthritis, and it also has a beneficial effect in psoriasis. Postmarketing studies have shown that retention on treatment with leflunomide is equal to methotrexate and superior to other DMARDs. In general, its side effect profile is acceptable compared with other DMARDS, with nausea, diarrhea, and hair fall occurring commonly, but only rarely leading to discontinuation. Liver toxicity is the most significant problem in clinical use although it is uncommon. Peripheral neuropathy, hypertension, pneumonitis, and cytopenia occur more rarely. Leflunomide is contraindicated in pregnancy and should be used with caution in women during child-bearing years. In this review, the place of leflunomide in therapy

  5. One year in an Alaskan arthritis clinic.

    Science.gov (United States)

    Templin, D

    1999-10-01

    During 1997 visits were made by 852 individuals to an arthritis clinic in Alaska serving predominantly Alaska Natives. Three hundred twenty- seven of these were seen for the first time. The ratio of women to men was 3:1. Rheumatoid Arthritis was the most common arthritic condition seen, followed by Degenerative Joint Disease and Spondyloarthropathies. Three hundred five Tlingit and 246 Eskimo made up 65% of the patients seen that year. Methotrexate was the most frequently used Disease Modifying Antirheumatic Drug but the other such drugs were prescribed as well. Recording demographic and clinical information on a portable computer at the time of visit provided record linkage and the data for this report and was used in Health Care Planning.

  6. Testing of the preliminary OMERACT validation criteria for a biomarker to be regarded as reflecting structural damage endpoints in rheumatoid arthritis clinical trials: the example of C-reactive protein

    DEFF Research Database (Denmark)

    Keeling, Stephanie O; Landewe, Robert; van der Heijde, Desiree;

    2007-01-01

    OBJECTIVE: A list of 14 criteria for guiding the validation of a soluble biomarker as reflecting structural damage endpoints in rheumatoid arthritis (RA) clinical trials was drafted by an international working group after a Delphi consensus exercise. C-reactive protein (CRP), a soluble biomarker...... of individual criteria in the draft set. METHODS: A systematic literature review was conducted to elicit evidence in support of each specific criterion composing the 14-criteria draft set. A summary of the key literature findings per criterion was presented to both the working group and to participants......-based survey. RESULTS: Minimal data were extracted from the literature pertaining to those criteria listed under the category of truth. Ratings for strength of evidence were moderate to low (

  7. Synovial tissue rank ligand expression and radiographic progression in rheumatoid arthritis: observations from a proof-of-concept randomized clinical trial of cytokine blockade.

    LENUS (Irish Health Repository)

    Rooney, Terence

    2012-02-01

    The objective of the study was to evaluate synovial tissue receptor activator of nuclear factor-kappabeta ligand (RANKL) and osteoprotegerin (OPG) as biomarkers of disease activity, progressive joint damage, and therapeutic response, during cytokine blockade in rheumatoid arthritis (RA). Patients with active RA entered a randomized open-label 12-month study of anakinra 100 mg\\/day, administered as monotherapy or in combination with pegsunercept 800 mug\\/kg twice weekly. Arthroscopic synovial tissue biopsies were obtained at baseline, at 4 weeks and at the final time point. Following immunohistochemical staining, RANKL and OPG expression was quantified using digital image analysis. Radiographic damage was evaluated using the van der Heijde modification of the Sharp scoring system. Twenty-two patients were randomized. Baseline expression of RANKL, but not OPG, correlated significantly with baseline CRP levels (r = 0.61, P < 0.01). While a significant reduction in OPG expression following treatment was observed in clinical responders at the final time point (P < 0.05 vs. baseline), RANKL levels did not change, and the RANKL:OPG ratio remained unaltered, even at the highest levels of clinical response. When potential predictors of radiographic outcome were evaluated, baseline RANKL expression correlated with erosive progression at 1 year (r = 0.71, P < 0.01). Distinct, though related, pathophysiologic processes mediate joint inflammation and destruction in RA. Elevated synovial tissue RANKL expression is associated with progressive joint erosion, and may be independent of the clinical response to targeted therapy. The potential therapeutic importance of modulating RANKL in RA is highlighted, if radiographic arrest is to be achieved.

  8. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

    Directory of Open Access Journals (Sweden)

    Sternlieb Beth

    2011-01-01

    Full Text Available Abstract Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823

  9. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  10. Juvenile idiopathic arthritis: a clinical overview

    Energy Technology Data Exchange (ETDEWEB)

    Davidson, J

    2000-02-01

    The chronic arthritides in childhood remain a poorly understood group of conditions. Their classification has been a source of much confusion over the years with differences in terminology between Europe and North America. A significant step forward in paediatric rheumatology has been the recent development of an internationally agreed classification system which uses the overall term juvenile idiopathic arthritis (JIA). The various subtypes of JIA and their clinical features are described, together with an overview of their differential diagnosis, complications and outcomes. An outline of current management strategies is given and potential future developments highlighted.

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... a disease. A clinical trial may compare experimental products or tests to those already available or may ... Institutes of Health | U.S. Department of Health & Human Services Customer Support | Accessibility | Copyright | Privacy | Viewers and Players

  12. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  14. Falsificationism and clinical trials.

    Science.gov (United States)

    Senn, S J

    1991-11-01

    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  15. Clinical and immunologic effects of fractionated total lymphoid irradiation in refractory rheumatoid arthritis

    Energy Technology Data Exchange (ETDEWEB)

    Trentham, D.E. (Harvard Medical School, Boston, MA); Belli, J.A.Anderson, R.J.; Buckley, J.A.; Goetzl, E.J.; David, J.R.; Austen, K.F.

    1981-10-01

    Ten patients with refractory rheumatoid arthritis were given 3000 rad of fractionated total lymphoid irradiation in an uncontrolled therapeutic trial. Total lymphoid irradiation was associated with objective evidence of considerable clinical improvement in eight patients and with reduced blood lymphocyte counts in all 10. On completion of irradiation, there was an abrogation of lymphocyte reactivity in vitro in the patients with clinical responses, but abnormal antibody activities characteristic of rheumatoid arthritis and normal components of humoral immunity were not suppressed. Partial recrudescence of arthritis occurred shortly before a year after the completion of irradiation and was paralleled by a restitution of lymphocyte concentrations and responsiveness to mitogens to levels similar to those observed before irradiation. These data provide further evidence of T-cell involvement in the pathogenesis of rheumatoid arthritis and demonstrate that total lymphoid irradiation can induce temporary relief, but they do not ascertain whether the natural history of this disease was altered.

  16. Clinical and immunologic effects of fractionated total lymphoid irradiation in refractory rheumatoid arthritis

    Energy Technology Data Exchange (ETDEWEB)

    Trentham, D.E.; Belli, J.A.; Anderson, R.J.; Buckley, J.A.; Goetzl, E.J.; David, J.R.; Austen, K.F.

    1981-10-22

    Ten patients with refractory rheumatoid arthritis were given 3000 rad of fractionated total lymphoid irradiation in an uncontrolled therapeutic trial. Total lymphoid irradiation was associated with objective evidence of considerable clinical improvement in eight patients and with reduced blood lymphocyte counts in all 10. On completion of irradiation, there was an abrogation of lymphocyte reactivity in vitro in the patients with clinical responses, but abnormal antibody activities characteristic of rheumatoid arthritis and normal components of humoral immunity were not suppressed. Partial recrudescence of arthritis occurred shortly after a year after the completion of irradiation and was paralleled by a restitution of lymphocyte concentrations and responsiveness to mitogens to levels similar to those observed before irradiation. These data provide further evidence of T-cell involvement in the pathogenesis of rheumatoid arthritis and demonstrate that total lymphoid irradiation can induce temporary relief, but they do not ascertain whether the natural history of this disease was altered.

  17. Clinical Orofacial Examination in Juvenile Idiopathic Arthritis

    DEFF Research Database (Denmark)

    Stoustrup, Peter; Twilt, Marinka; Spiegel, Lynn

    2017-01-01

    review. The level of evidence for the 5 recommendations was derived primarily from descriptive studies, such as cross-sectional and case-control studies. CONCLUSION: Five recommendations are proposed for the orofacial examination of patients with JIA to improve the clinical practice and aid standardized......OBJECTIVE: To develop international consensus-based recommendations for the orofacial examination of patients with juvenile idiopathic arthritis (JIA), for use in clinical practice and research. METHODS: Using a sequential phased approach, a multidisciplinary task force developed and evaluated...... a set of recommendations for the orofacial examination of patients with JIA. Phase 1: A Delphi survey was conducted among 40 expert physicians and dentists with the aim of identifying and ranking the importance of items for inclusion. Phase 2: The task force developed consensus about the domains...

  18. Clinical Trial Basics

    Science.gov (United States)

    ... How Am I Protected? Mark Bowden / iStock Ethical guidelines The goal of clinical research is to develop knowledge that improves human ... data and decide whether the results have medical importance. Results from clinical trials are often published in peer-reviewed scientific ...

  19. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...

  20. Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: Rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives

    OpenAIRE

    Sparks, Jeffrey A.; Iversen, Maura D.; Kroouze, Rachel Miller; Mahmoud, Taysir G.; Triedman, Nellie A.; Kalia, Sarah S.; Atkinson, Michael L.; Lu, Bing; Deane, Kevin D.; Costenbader, Karen H.; Green, Robert C.; Elizabeth W. Karlson

    2014-01-01

    We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concernin...

  1. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.;

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...... and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...... that target symptom or structure modification among individuals with knee OA. These updated recommendations incorporate novel technologies (e.g., magnetic resonance imaging (MRI)) and strategies to address the heterogeneity of knee OA....

  2. PSORIATIC ARTHRITIS: CLASSIFICATION, CLINICAL PRESENTATION, DIAGNOSIS, TREATMENT

    Directory of Open Access Journals (Sweden)

    T. V. Korotaeva

    2014-01-01

    Full Text Available The lecture gives basic information about psoriatic arthritis (PsA, a chronic inflammatory disease of the joints, spine, and enthesises from a group of spondyloarthritis. It describes the epidemiology of the disease and considers current ideas on its pathogenesis and factors influencing the development of PsA in psoriatic patients. The classification and clinical forms of PsA are presented. The major clinical manifestations of the disease are indicated to include peripheral arthritis, enthesitis, dactylitis, and spondylitis. The diagnosis of the disease is noted to be established on the basis of its detected typical clinical and radiological signs, by applying the CASPAR criteria. A dermatologist, rheumatologist, and general practitioner screen PsA, by actively detecting complaints, characteristic clinical and radiological signs of damage to the joints, and/or spine, and/or enthesises and by using screening questionnaires. There are data that patients with PsA are observed to be at higher risk for a number of diseases type 2 diabetes mellitus hypertension, coronary heart disease, obesity, metabolic syndrome, inflammatory bowel diseases, etc. The aim of current pharmacotherapy for PsA is to achieve remission or minimal activity of clinical manifestations of the disease, to delay or prevent its X-ray progression, to increase survival, to improve quality of life in patients, and to reduce the risk of comorbidities. The paper considers groups of medicines used to treat the disease, among other issues, information about biological agents (BA registered in the Russian Federation for the treatment of PsA. Most patients are mentioned to show a good response to this therapy option just 3–6 months after treatment initiation; however, some of them develop primary inefficiency. In this case, switching one BA to another is recommended. Some patients using a BA develop secondary treatment inefficiency, which is firstly due to the appearance of

  3. Traditional Chinese medicine: potential for clinical treatment of rheumatoid arthritis.

    Science.gov (United States)

    Moudgil, Kamal D; Berman, Brian M

    2014-07-01

    Rheumatoid arthritis (RA) is a chronic debilitating autoimmune disease affecting people worldwide. Increasing numbers of RA patients in the west are resorting to various complementary and alternative medicine modalities for relief of symptoms and well-being. Herbal products and acupuncture representing traditional Chinese medicine (TCM) are two of the most commonly used forms of complementary and alternative medicine. Frequently, their efficacy against RA and safety have been inferred from anecdotal experience or pilot testing on a relatively small number of patients following inadequate study designs. Accordingly, significant efforts need to be invested in objectively testing TCM in clinical trials that are sufficiently powered, randomized, blinded, possess appropriate controls and follow standard criteria for assessment of the outcomes. In addition, the mechanisms underlying the immunomodulatory and other antiarthritic activities of TCM modalities need to be better defined. These efforts would help validate the scientific rationale for the use of TCM for the management of RA.

  4. Participating in Clinical Trials

    Medline Plus

    Full Text Available skip navigation Help Search home health topics A-Z Videos A-Z about us Customer Support NIH SeniorHealth Built with You in Mind Resize Text: A A A Change Contrast print sign up Share Home > Health topics A-Z > Participating in Clinical Trials: About ...

  5. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... will not know if you are taking the medicine or the placebo until the clinical trial is over. How do ... can already get by prescription ) or sugar pills ( placebos ) with the new medicine may last longer than Phases I and II ...

  6. CLINICAL HETEROGENEITY OF EARLY PSORIATIC ARTHRITIS

    Directory of Open Access Journals (Sweden)

    V. V. Badokin

    2016-01-01

    Full Text Available Objective: to reveal the characteristic symptoms and syndromes of early-stage psoriatic arthritis (ePsA, which are pivotal to its early diagnosis.Patients and methods. Fifty-one patients with a PsA duration of less than 2 years (mean 12 months were examined. The diagnosis of PsA was established on the basis of the conventional CASPAR criteria and the Russian criteria developed by the expert method. The conventional current criteria, including the number of tender and swollen joints, DAS28, values of acute-phase indicators, were used to detect inflammatory activity. Skin syndrome was evaluated using the Psoriasis Area and Severity Index (PASI. X-ray study of the hands, distal and proximal feet, pelvis, and other involved joints and MRI of the distal hands/feet were performed. The Maastricht Ankylosing Spondylitis Enthesitis Score (MASES and reduced GUESS were used to assess enthesopathy.Results. The types of articular syndrome in ePsA were identified in accordance of the duration of the disease. The authors determined the characteristic features of arthritis, spondylitis, enthesitis, and dactylitis, their diagnostic value and associations with other manifestations in the first 2 years of PsA. There was a relationship of dermatitis and psoriatic onychopathy to the clinical picture of articular syndrome.Conclusion. ePsA is characterized by marked heterogeneity of articular syndrome with predominantly mono/oligoarthritic and polyarthritic articular syndrome. The significant signs are enthesitis and dactylitis, which serve as risk factors for the unfavorable course of the disease. 

  7. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations.

    Science.gov (United States)

    Ajeganova, Sofia; Huizinga, Tom

    2017-10-01

    Sustained remission is an ultimate treatment goal in the management of patients with rheumatoid arthritis (RA). Historically the frequency of sustained remission was low but the frequency of achieved sustained remission is increasing over time. The last years' clinical studies of tight control targeted treatment and intervention trials of early use of intensive strategy suggest that these treatment strategies are associated with higher rates of sustained remission. Achievement of sustained remission, in particular but not limited to early sustained remission, can provide tapering and stopping disease-modifying antirheumatic drugs (DMARDs). With new treatment strategies drug-free sustained remission is becoming an achievable goal. Sustained remission is associated with improved outcomes in regard to function, patient-reported outcomes and survival. Drug-free sustained remission is characterized by normalized function ability and survival. Sustained remission and, in particular, drug-free sustained remission offer hope that early identification of patients with arthritis, early improved novel treatments and treatment with target to achieve remission may potentially transform the progressive course of RA disease and disrupt RA chronicity. In this review we summarize the recent evidence on sustained remission in patients with RA, treatment strategies to achieve sustained remission, management of patients in sustained remission and significance of sustained remission from the patient perspective.

  8. Ethics and clinical trials.

    Science.gov (United States)

    Chassany, O; Duracinský, M

    1999-01-01

    The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.

  9. What Are Clinical Trial Phases?

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    Full Text Available ... Trials Insurance Coverage and Clinical Trials How to Work With Your Health Insurance Plan Federal Government Programs Patient Safety Informed Consent Children's Assent Scientific Review Ending Trials Early Deciding to Take Part ...

  10. A commentary on TREAT: The trial of early aggressive drug therapy in juvenile idiopathic arthritis

    Directory of Open Access Journals (Sweden)

    Baildam Eileen

    2012-06-01

    Full Text Available Abstract Polyarticular juvenile idiopathic arthritis (JIA is a category of JIA where multiple joints are affected by chronic inflammation, and where serious and lasting damage to joints is the expected natural history in untreated disease. There is evidence of response to disease-modifying antirheumatic and biologic drugs, but little evidence of permanent remission from any of the existing therapeutic trials. The TREAT trial by Wallace et al., recently published in Arthritis and Rheumatism, used a collaborative multicenter approach to studying early aggressive treatment of polyarticular JIA in an attempt to achieve full clinical inactive disease after 6 months of treatment. The study's main finding that the earlier in the disease course that treatment is started, the better the chance of disease control, has provided evidence that there is a 'window of opportunity' for treating JIA as there is in adult rheumatoid arthritis (RA. The study provides both a platform and an impetus for concentrating future treatment trials on early rather than established disease and investigating a standard of starting treatment within 10 to 12 weeks.

  11. Clinical outcome measures in juvenile idiopathic arthritis.

    Science.gov (United States)

    Consolaro, Alessandro; Giancane, Gabriella; Schiappapietra, Benedetta; Davì, Sergio; Calandra, Serena; Lanni, Stefano; Ravelli, Angelo

    2016-04-18

    Juvenile idiopathic arthritis (JIA), as a chronic condition, is associated with significant disease- and treatment-related morbidity, thus impacting children's quality of life. In order to optimize JIA management, the paediatric rheumatologist has begun to regularly use measurements of disease activity developed, validated and endorsed by international paediatric rheumatology professional societies in an effort to monitor the disease course over time and assess the efficacy of therapeutic interventions in JIA patients.A literature review was performed to describe the main outcome measures currently used in JIA patients to determine disease activity status.The Juvenile Disease Activity Score (JADAS), in its different versions (classic JADAS, JADAS-CRP and cJADAS) and the validated definitions of disease activity and response to treatment represent an important tool for the assessment of clinically relevant changes in disease activity, leading more and more to a treat-to-target strategy, based on a tight and thorough control of the patient condition. Moreover, in recent years, increasing attention on the incorporation of patient-reported or parent-reported outcomes (PRCOs), when measuring the health state of patients with paediatric rheumatic diseases has emerged.We think that the care of JIA patients cannot be possible without taking into account clinical outcome measures and, in this regard, further work is required.

  12. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2007-01-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: 4'-Thio-ara-C, 5-methyltetrahydrofolate; ABT-089, AD-237, AF-37702, alvocidib hydrochloride, apricitabine, armodafinil, atrasentan, AVE-5883, avian influenza vaccine, azimilide hydrochloride; Banoxantrone, BIBF-1120; CD34+ cells, certolizumab pegol, CHIR-258, cilansetron, CoFactor, CX-3543, cystemustine; D-003, dexloxiglumide, DMXB-anabaseine; Ecogramostim, elcometrine, elcometrine/ethinylestradiol, etravirine; Fenretinide, fingolimod hydrochloride, fospropofol disodium; Gaboxadol, gestodene, glutamine; Human insulin, hyaluronic acid; Incyclinide, indacaterol, ispronicline, istradefylline; Labradimil, lamifiban, lapatinib, L-arginine hydrochloride, liposomal cisplatin, liposome encapsulated paclitaxel, LY-517717; Manidipine hydrochloride/delapril hydrochloride, maraviroc, MBP(82-98), MD-0727, MDX-214, melanotan I, MMR vaccine; Nacystelyn, nalfurafine hydrochloride, nibentan, nilotinib, NK-105; OBI-1, oblimersen sodium, olmesartan medoxomil, olmesartan medoxomil/hydrochlorothiazide, oregovomab; Pexelizumab, PG-116800, PG-CPT, PHA-794428, prasugrel; RC-3095, rDNA insulin, RFB4(dsFv)-PE38, rhEndostatin, rhenium Re-186 etidronate, rhGM-CSF, roflumilast, romidepsin; Sarcosine, SGLU1, SGN-40, succinobucol; TAU, teduglutide, telatinib, tesofensine, tipifarnib, tirapazamine, TKA-731, tolvaptan, trabectedin; Vaccimel, vatalanib succinate, velafermin, vildagliptin, vinflunine; XP-19986; YM-155.

  13. Etanercept in the treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory polyarticular course juvenile idiopathic arthritis: experience from Japanese clinical trials.

    Science.gov (United States)

    Mori, Masaaki; Takei, Syuji; Imagawa, Tomoyuki; Imanaka, Hiroyuki; Nerome, Yasuhito; Kurosawa, Rumiko; Kawano, Yoshifumi; Yokota, Shumpei; Sugiyama, Noriko; Yuasa, Hirotoshi; Fletcher, Tracey; Wajdula, Joseph S

    2011-12-01

    Efficacy, safety, and pharmacokinetics results from 4 studies-3 open-label (OL) and 1 randomized double-blind (DB)-have provided data for approval of etanercept for treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory juvenile idiopathic arthritis (JIA) in Japan. Results from the 3 shorter-term (2 OL and 1 DB) studies are reported here. Subjects (4-17 years) enrolled in the OL studies had active JIA, i.e. ≥5 swollen joints and ≥3 joints with limitation of motion and pain or tenderness. Subjects enrolled in the primary OL study received etanercept 0.4 mg/kg subcutaneously twice weekly; in the lower-dose OL study subjects received etanercept 0.2 mg/kg. Subjects in the primary OL study who completed ≥48 weeks could continue into a 12-week DB dose-down extension study in which subjects received etanercept 0.4 or 0.2 mg/kg twice weekly. The primary endpoint in all 3 studies, i.e. 30% improvement in the American College of Rheumatology criteria for JIA (ACR Pedi 30) at 12 weeks, was achieved by ≥80% of subjects by week 2 and sustained to week 12. Common adverse events reported were injection site reactions, nasopharyngitis, and gastroenteritis. These results provide further evidence that etanercept is effective therapy for DMARD-refractory polyarticular JIA patients.

  14. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...

  16. Glenohumeral arthritis after Latarjet procedure: Progression and it's clinical significance.

    Science.gov (United States)

    Kee, Young Moon; Kim, Hwan Jin; Kim, Jung Youn; Rhee, Yong Girl

    2017-09-01

    The risk factors of glenohumeral arthritis after the Latarjet procedure remain relatively unexplored. The purposes of this study are to evaluate the clinical significance of glenohumeral arthritis after the Latarjet procedure, and to investigate risk factors associated with arthritis progression. We evaluated 110 patients (110 shoulders) who underwent the Latarjet procedure for recurrent anterior shoulder instability. Patients had a mean age of 23.8 years (range, 14-52 years) at the time of the operation, and the mean duration of follow-up was 31 months (range, 24-111 months). At the last follow-up, the mean Visual Analog Scale (VAS), Rowe and University of California at Los Angeles (UCLA) scores significantly improved from 3.1, 36.5 and 23.6 points preoperatively to 1.6, 87.6 and 32.6 points (all P Latarjet procedure was in 20 shoulders (18.2%). At the final, overall prevalence of arthritis was 23.6% (26 shoulders). The non-arthritis group showed significantly better functional outcomes (VAS score: 0.9, Rowe Score: 89.3, UCLA score: 33.5) than the arthritis group (2.1, 84.9, 29.2; all P Latarjet procedure yielded satisfactory functional outcomes with low recurrent rate at mid-term follow-up. Development or progression of arthritis was observed in 18.2% of patients, postoperatively. Glenohumeral arthritis after the Latarjet procedure had an adverse effect on clinical outcome. Generalized laxity and lateral overhang should be considered as risk factors of progression to glenohumeral arthritis after the Latarjet procedure. Copyright © 2017 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

  17. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  18. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study)

    Science.gov (United States)

    Kavanaugh, Arthur; McInnes, Iain B; Mease, Philip; Krueger, Gerald G; Gladman, Dafna; van der Heijde, Désirée; Zhou, Yiying; Lu, Jiandong; Leu, Jocelyn H; Goldstein, Neil; Beutler, Anna

    2014-01-01

    Objectives Assess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA). Methods Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-protein-based, 28-joint-count Disease Activity Score (DAS28-CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs). Results 126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8–72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate). Conclusions Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years. Trial registration number NCT00265096. PMID:24748630

  19. What Are Clinical Trial Phases?

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    Full Text Available ... Trials Information A to Z List of Cancer Drugs Complementary & Alternative Medicine (CAM) Questions to Ask about ... Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer Adjusting to ...

  20. What Are Clinical Trial Phases?

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    Full Text Available ... Unusual Cancers of Childhood Treatment Childhood Cancer Genomics Study Findings Metastatic Cancer Metastatic Cancer Research Common Cancer ... Trials Insurance Coverage and Clinical Trials How to Work With Your Health Insurance Plan Federal Government Programs ...

  1. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Trials Information A to Z List of Cancer Drugs Complementary & Alternative Medicine (CAM) Questions to Ask about ... Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer Adjusting to ...

  2. 77 FR 35988 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2012-06-15

    ... HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and... unwarranted invasion of personal privacy. Name of Committee: Arthritis and Musculoskeletal and Skin Diseases Initial Review Group; Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review...

  3. 78 FR 58320 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2013-09-23

    ... HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and... unwarranted invasion of personal privacy. Name of Committee: Arthritis and Musculoskeletal and Skin Diseases Initial Review Group; Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review...

  4. 78 FR 38065 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2013-06-25

    ... HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and... unwarranted invasion of personal privacy. Name of Committee: Arthritis and Musculoskeletal and Skin Diseases Initial Review Group; Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review...

  5. 77 FR 61011 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2012-10-05

    ... HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and... unwarranted invasion of personal privacy. Name of Committee: Arthritis and Musculoskeletal and Skin Diseases Initial Review Group; Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review...

  6. 78 FR 8549 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2013-02-06

    ... HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and... unwarranted invasion of personal privacy. Name of Committee: Arthritis and Musculoskeletal and Skin Diseases Initial Review Group; Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review...

  7. 77 FR 12605 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2012-03-01

    ... HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and... invasion of personal privacy. Name of Committee: Arthritis and Musculoskeletal and Skin Diseases Initial Review Group, Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review Committee....

  8. 77 FR 39714 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2012-07-05

    ... Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting Pursuant to section... Institute of Arthritis and Musculoskeletal and Skin Diseases, Special Emphasis Panel, Clinical Trials... of Arthritis, Musculoskeletal and Skin Diseases, National Institutes of Health, 6701 Democracy...

  9. 'Clinical features of women with gout arthritis' : a systematic review

    NARCIS (Netherlands)

    Dirken-Heukensfeldt, K.J.; Teunissen, T.A.M.; Lisdonk, E.H. van de; Lagro-Janssen, A.L.M.

    2010-01-01

    Clinically, gout is generally considered as a preferential male disease. However, it definitely does not occur exclusively in males. Our aim was to assess differences in the clinical features of gout arthritis between female and male patients. Five electronic databases were searched to identify rele

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial. Prevention Trials Click for more information In prevention trials, researchers study ways to reduce the risk of getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  11. [Critical reading of clinical trials].

    Science.gov (United States)

    Aptel, F; Cucherat, M; Blumen-Ohana, E; Denis, P

    2011-12-01

    Clinical trials are playing an increasingly crucial role in modern evidence based medicine, allowing for rigorous scientific evaluation of treatment strategies and validation of patient care. The results of clinical trials often form the rational basis from which physicians draw information used to adapt their therapeutic practices. Critical reading and analysis of trials involves the assessment of whether the available data provide enough credible evidence that the treatment will result in a clinically significant and relevant improvement. Evaluating the quality of a clinical trial is a process that draws upon sometimes complex methodological and statistical concepts, with which the reader should nonetheless be familiar in order to come to impartial conclusions regarding the raw data presented in the clinical trials. The goal of the current article is to review the methodological and statistical concepts required for the design and interpretation of clinical trials, so as to allow for a critical analysis of publications or presentations of clinical trials. The first section describes the major methodological principles of clinical trial design required for a rigorous evaluation of the treatment benefit, as well as the various pitfalls or biases that could lead to erroneous conclusions. The second section briefly describes the main statistical tests used in clinical trials, as well as certain situations that may increase the risk of false positive findings (type 1 error), such as multiple, subgroup, intermediate and non-inferiority analysis. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  12. What Are Clinical Trial Phases?

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    Full Text Available ... Phases of Clinical Trials Cancer Treatment Types of Cancer Treatment Surgery Radiation Therapy Chemotherapy Immunotherapy Targeted Therapy Hormone Therapy Stem Cell Transplant Precision ...

  13. A guide to clinical trials for cancer

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/patientinstructions/000823.htm A guide to clinical trials for cancer To use ... trial and where to find one. What is a Clinical Trial for Cancer? Clinical trials for cancer ...

  14. Yoga in Sedentary Adults with Arthritis: Effects of a Randomized Controlled Pragmatic Trial.

    Science.gov (United States)

    Moonaz, Steffany Haaz; Bingham, Clifton O; Wissow, Lawrence; Bartlett, Susan J

    2015-07-01

    To evaluate the effect of Integral-based hatha yoga in sedentary people with arthritis. There were 75 sedentary adults aged 18+ years with rheumatoid arthritis (RA) or knee osteoarthritis randomly assigned to 8 weeks of yoga (two 60-min classes and 1 home practice/wk) or waitlist. Poses were modified for individual needs. The primary endpoint was physical health [Medical Outcomes Study Short Form-36 (SF-36) physical component summary (PCS)] adjusted for baseline; exploratory adjusted outcomes included fitness, mood, stress, self-efficacy, SF-36 health-related quality of life (HRQOL), and RA disease activity. In everyone completing yoga, we explored longterm effects at 9 months. Participants were mostly female (96%), white (55%), and college-educated (51%), with a mean (SD) age of 52 years (12 yrs). Average disease duration was 9 years and 49% had RA. At 8 weeks, yoga was associated with significantly higher PCS (6.5, 95% CI 2.0-10.7), walking capacity (125 m, 95% CI 15-235), positive affect (5.2, 95% CI 1.4-8.9), and lower Center for Epidemiologic Studies Depression Scale (-3.0, 95% CI -4.8 - -1.3). Significant improvements (p yoga. Among all yoga participants, significant (p yoga. Preliminary evidence suggests yoga may help sedentary individuals with arthritis safely increase physical activity, and improve physical and psychological health and HRQOL. Clinical Trials NCT00349869.

  15. Participating in Clinical Trials

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    Full Text Available ... Institutes of Health funds much of this basic research. Screening Trials In screening trials, researchers study ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging tests ...

  16. A longitudinal, qualitative study exploring sustained adherence to a hand exercise programme for Rheumatoid Arthritis evaluated in the SARAH Trial

    OpenAIRE

    2016-01-01

    Purpose:\\ud This study explores the experience of participants taking part in a hand exercise programme for people with rheumatoid arthritis with a focus on adherence. The exercise programme was tested in a randomised controlled trial. This parallel qualitative study will inform future implementation into clinical practice. \\ud \\ud Method:\\ud Twenty-seven semi-structured interviews from 14 participants were undertaken at 2 time points (4 and 12 months after randomisation). We collected data o...

  17. Clinical and Epidemiological Characterization of Patients with Rheumatoid Arthritis

    Directory of Open Access Journals (Sweden)

    Zoe Alina González Otero

    2015-12-01

    Full Text Available Background: rheumatoid arthritis is a chronic systemic inflammatory disease, it has varied clinical manifestations and cause different degrees of discomfort and disability. Objective: to conduct a clinical and epidemiological characterization of all rheumatoid arthritis patients admitted to the clinical services of the Arnaldo Milián Castro Provincial University Hospital. Methods: a cross-sectional study was conducted in the clinical services of the Arnaldo Milián Castro University Hospital from 2009 through 2013. The universe consisted of 280 patients hospitalized due to rheumatoid arthritis. The following variables were studied: age, sex, skin color, past medical history, clinical manifestations, complications, affected organs, time of diagnosis and treatment. Chi square and prevalence ratio with a 95% confidence interval were calculated. Results: arthritis was found in 2 men every 5 women. White middle-aged patients predominated. Hypertension was the major illness described in the past medical history. Arthralgia and movement limitations prevailed. No family history of rheumatic disease was found. The time of diagnosis was less than six months and infection was among the most frequent complications. The most common treatment was the combination of non-steroidal anti-inflammatory drugs and steroids, especially in seropositive patients. Conclusions: rheumatoid arthritis was more common in females and white middle-aged patients. Hypertension was the major illness found in the past medical history. Patients with two target organs affected predominated. Arthralgia and movement limitations prevailed in the clinical picture. The most common treatment was the combination of non-steroidal anti-inflammatory drugs and steroids.

  18. The Dynamo Clinical Trial

    Science.gov (United States)

    Ayres, Thomas R.

    2016-04-01

    The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)

  19. Participating in Clinical Trials

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    Full Text Available ... disease or prevent a disease from returning. Supportive Care Trials In supportive care trials, researchers look for ways to make life ... groups, and various types of social interventions. Supportive care interventions are not intended to treat or cure ...

  20. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  1. Protocol for the Foot in Juvenile Idiopathic Arthritis trial (FiJIA: a randomised controlled trial of an integrated foot care programme for foot problems in JIA

    Directory of Open Access Journals (Sweden)

    Hendry Gordon J

    2009-06-01

    Full Text Available Abstract Background Foot and ankle problems are a common but relatively neglected manifestation of juvenile idiopathic arthritis. Studies of medical and non-medical interventions have shown that clinical outcome measures can be improved. However existing data has been drawn from small non-randomised clinical studies of single interventions that appear to under-represent the adult population suffering from juvenile idiopathic arthritis. To date, no evidence of combined therapies or integrated care for juvenile idiopathic arthritis patients with foot and ankle problems exists. Methods/design An exploratory phase II non-pharmacological randomised controlled trial where patients including young children, adolescents and adults with juvenile idiopathic arthritis and associated foot/ankle problems will be randomised to receive integrated podiatric care via a new foot care programme, or to receive standard podiatry care. Sixty patients (30 in each arm including children, adolescents and adults diagnosed with juvenile idiopathic arthritis who satisfy the inclusion and exclusion criteria will be recruited from 2 outpatient centres of paediatric and adult rheumatology respectively. Participants will be randomised by process of minimisation using the Minim software package. The primary outcome measure is the foot related impairment measured by the Juvenile Arthritis Disability Index questionnaire's impairment domain at 6 and 12 months, with secondary outcomes including disease activity score, foot deformity score, active/limited foot joint counts, spatio-temporal and plantar-pressure gait parameters, health related quality of life and semi-quantitative ultrasonography score for inflammatory foot lesions. The new foot care programme will comprise rapid assessment and investigation, targeted treatment, with detailed outcome assessment and follow-up at minimum intervals of 3 months. Data will be collected at baseline, 6 months and 12 months from baseline

  2. Designing clinical trials for amblyopia.

    Science.gov (United States)

    Holmes, Jonathan M

    2015-09-01

    Randomized clinical trial (RCT) study design leads to one of the highest levels of evidence, and is a preferred study design over cohort studies, because randomization reduces bias and maximizes the chance that even unknown confounding factors will be balanced between treatment groups. Recent randomized clinical trials and observational studies in amblyopia can be taken together to formulate an evidence-based approach to amblyopia treatment, which is presented in this review. When designing future clinical studies of amblyopia treatment, issues such as regression to the mean, sample size and trial duration must be considered, since each may impact study results and conclusions. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. Data fraud in clinical trials

    Science.gov (United States)

    George, Stephen L; Buyse, Marc

    2015-01-01

    Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality. PMID:25729561

  4. Participating in Clinical Trials

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    Full Text Available ... to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase ...

  5. Participating in Clinical Trials

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    Full Text Available ... out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or ... specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  6. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  7. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... new tests that could identify a disease in its early stages. Usually, trial participants must show signs ... often healthy people (20 to 80), to judge its safety and side effects, and to find the ...

  8. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    ... and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help researchers ... to HIV Can anyone participate in an HIV/AIDS clinical trial? It depends on the study. Some ...

  9. Inept media trials of clinical trials

    Directory of Open Access Journals (Sweden)

    N V Ramamurthy

    2012-01-01

    Full Text Available The Indian media in general, with the exception of a few domain expert journalists, have failed to comprehend the complexities involved in the clinical trial process. In the run up to the deadline-based coverage of a story, a majority of them fall short in conveying the right perspective to readers, but nevertheless they have been successful in sensationalizing an event in this arena. Possibly by unintended misrepresentation, or mostly out of ignorance of the nuances involved in the clinical trials process, the media has done more harm than good, and got away with it. On the other side, the industry has been reluctant to engage with the media in a meaningful dialog for too long now. It bears not only the consequences of damage to its professional reputation following such reportage, but also the repercussions of unnecessary clampdowns by the regulators. Science journalism in India has yet to rise as a profession.

  10. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Contacts Other Funding Find NCI funding for small business innovation, technology transfer, and contracts Training Cancer Training ...

  11. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Cancer Research and Discovery Stories of Discovery R&D Resources Conducting Clinical Trials Statistical Tools and Data ... about some of NCI's major research initiatives R&D Resources Tools and data sets for researchers Research ...

  12. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Bladder Cancer Breast Cancer Colorectal Cancer Kidney (Renal Cell) Cancer Leukemia Liver Lung Cancer Lymphoma Pancreatic Cancer ... Therapy Chemotherapy Immunotherapy Targeted Therapy Hormone Therapy Stem Cell Transplant Precision Medicine Side Effects Clinical Trials Information ...

  13. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Report (RPPR) Grant Closeout Grant Resources NCI Grants Management Legal Requirements NCI Grant Policies Grants Management Contacts ...

  14. What Are Clinical Trial Phases?

    Science.gov (United States)

    ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Report (RPPR) Grant Closeout Grant Resources NCI Grants Management Legal Requirements NCI Grant Policies Grants Management Contacts ...

  15. Differences between participants and nonparticipants in an exercise trial for adults with rheumatoid arthritis.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Jansen, L.M.; Ronday, K.; Schaardenburg, D.J. van; Brand, R.; Ende, C.H.M. van den; Vliet Vlieland, T.P.M.; Zuijderduin, W.M.; Hazes, J.M.

    2004-01-01

    OBJECTIVE: To investigate the generalizability of the results of a randomized controlled trial on the effectiveness of long-term, high-intensity exercises in the rheumatoid arthritis patients in training (RAPIT) trial by comparing the characteristics of the participants with the nonparticipants. MET

  16. A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial.

    Science.gov (United States)

    Cutolo, Maurizio; Myerson, Gary E; Fleischmann, Roy M; Lioté, Frédéric; Díaz-González, Federico; Van den Bosch, Filip; Marzo-Ortega, Helena; Feist, Eugen; Shah, Kamal; Hu, ChiaChi; Stevens, Randall M; Poder, Airi

    2016-09-01

    Apremilast, an oral phosphodiesterase 4 inhibitor, downregulates intracellular inflammatory mediator synthesis by elevating cyclic adenosine monophosphate levels. The PALACE 2 trial evaluated apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs and/or biologic therapy. Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg BID, or apremilast 30 mg BID. At Week 16, patients with swollen and tender joint count improvement 20% improvement in American College of Rheumatology response criteria (ACR20) at Week 16. In the intent-to-treat population (N = 484), ACR20 at Week 16 was achieved by more patients receiving apremilast 20 mg BID [37.4% (p = 0.0002)] and 30 mg BID [32.1% (p = 0.0060)] versus placebo (18.9%). Clinically meaningful improvements in signs and symptoms of PsA, physical function, and psoriasis were observed with apremilast through Week 52. The most common adverse events were diarrhea, nausea, headache, and upper respiratory tract infection. Diarrhea and nausea generally occurred early and usually resolved spontaneously with continued treatment. Laboratory abnormalities were infrequent and transient. Apremilast demonstrated clinical improvements in PsA for up to 52 weeks, including signs and symptoms, physical function, and psoriasis. No new safety signals were observed. ClinicalTrials.gov identifier: NCT01212757.

  17. Birth Control in Clinical Trials

    Science.gov (United States)

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  18. Patient-Reported Outcomes and the Association With Clinical Response in Patients With Active Psoriatic Arthritis Treated With Golimumab: Findings Through 2 Years of a Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

    Science.gov (United States)

    Kavanaugh, Arthur; McInnes, Iain B; Krueger, Gerald G; Gladman, Dafna; Beutler, Anna; Gathany, Tim; Mack, Michael; Tandon, Neeta; Han, Chenglong; Mease, Philip

    2013-01-01

    Objective To evaluate the effect of golimumab on physical function, health-related quality of life (HRQOL), and productivity in psoriatic arthritis (PsA). Methods GO-REVEAL was a multicenter, randomized, placebo-controlled study. Adult patients with active PsA (n = 405) received golimumab (50 or 100 mg) or placebo every 4 weeks, with early escape at week 16 (placebo → 50 mg, 50 → 100 mg) or placebo crossover to golimumab 50 mg at week 24. Patient-reported outcomes included physical function (Health Assessment Questionnaire [HAQ] disability index [DI] score), HRQOL (36-item Short Form health survey [SF-36] mental component summary [MCS] and physical component summary [PCS] scores), and productivity (home/school/work). Clinical response was assessed using the 28-joint Disease Activity Score using the C-reactive protein level (DAS28-CRP) and the Psoriasis Area and Severity Index (PASI) score for arthritis and skin symptoms, respectively. Results At week 24, golimumab-treated patients had significant mean improvements in HAQ DI (0.36), SF-36 (PCS 7.83, MCS 3.84), and productivity (2.24) scores compared with placebo (−0.01, 0.67, −0.60, and 0.08, respectively; P <0.001 for all). Also, greater proportions of golimumab- than placebo-treated patients had clinically meaningful improvements in HAQ DI (≥0.30) and SF-36 PCS and MCS (≥5) scores at week 24 (P <0.05). Also at week 24, improvements in DAS28-CRP scores were significantly but moderately correlated with improvements in HAQ DI, SF-36 PCS, and productivity scores. Correlations between these patient-reported outcomes and improvements in PASI, enthesitis, and dactylitis scores were very weak. Improvements in HAQ DI, SF-36, and productivity scores were similar among all groups by week 52 and week 104 when including placebo → golimumab crossover patients. Conclusion Golimumab-treated patients had significant improvements in physical function, HRQOL, and productivity through week 24; these improvements

  19. Quality-of-care standards for early arthritis clinics.

    Science.gov (United States)

    Ivorra, José Andrés Román; Martínez, Juan Antonio; Lázaro, Pablo; Navarro, Federico; Fernandez-Nebro, Antonio; de Miguel, Eugenio; Loza, Estibaliz; Carmona, Loreto

    2013-10-01

    The diagnosis and treatment of early arthritis is associated with improved patient outcomes. One way to achieve this is by organising early arthritis clinics (EACs). The objective of this project was to develop standards of quality for EACs. The standards were developed using the two-round Delphi method. The questionnaire, developed using the best-available scientific evidence, includes potentially relevant items describing the dimensions of quality of care in the EAC. The questionnaire was completed by 26 experts (physicians responsible for the EACs in Spain and chiefs of the rheumatology service in Spanish hospitals). Two hundred and forty-four items (standards) describing the quality of the EAC were developed, grouped by the following dimensions: (1) patient referral to the EAC; (2) standards of structure for an EAC; (3) standards of process; (4) relation between primary care physicians and the EAC; (5) diagnosis and assessment of early arthritis; (6) patient treatment and follow-up in the EAC; (7) research and training in an EAC; and (8) quality of care perceived by the patient. An operational definition of early arthritis was also developed based on eight criteria. The standards developed can be used to measure/establish the requirements, resources, and processes that EACs have or should have to carry out their treatment, research, and educational activities. These standards may be useful to health professionals, patient associations, and health authorities.

  20. Algorithm development for corticosteroid management in systemic juvenile idiopathic arthritis trial using consensus methodology

    Directory of Open Access Journals (Sweden)

    Ilowite Norman T

    2012-08-01

    Full Text Available Abstract Background The management of background corticosteroid therapy in rheumatology clinical trials poses a major challenge. We describe the consensus methodology used to design an algorithm to standardize changes in corticosteroid dosing during the Randomized Placebo Phase Study of Rilonacept in Systemic Juvenile Idiopathic Arthritis Trial (RAPPORT. Methods The 20 RAPPORT site principal investigators (PIs and 4 topic specialists constituted an expert panel that participated in the consensus process. The panel used a modified Delphi Method consisting of an on-line questionnaire, followed by a one day face-to-face consensus conference. Consensus was defined as ≥ 75% agreement. For items deemed essential but when consensus on critical values was not achieved, simple majority vote drove the final decision. Results The panel identified criteria for initiating or increasing corticosteroids. These included the presence or development of anemia, myocarditis, pericarditis, pleuritis, peritonitis, and either complete or incomplete macrophage activation syndrome (MAS. The panel also identified criteria for tapering corticosteroids which included absence of fever for ≥ 3 days in the previous week, absence of poor physical functioning, and seven laboratory criteria. A tapering schedule was also defined. Conclusion The expert panel established consensus regarding corticosteroid management and an algorithm for steroid dosing that was well accepted and used by RAPPORT investigators. Developed specifically for the RAPPORT trial, further study of the algorithm is needed before recommendation for more general clinical use.

  1. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.;

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...

  2. The clinical role of nuclear medicine in rheumatoid arthritis patients

    Energy Technology Data Exchange (ETDEWEB)

    Vos, K. (Leiden Univ. Medical Center (Netherlands). Dept. of Rheumatology); Van der Linden, E. (Leiden Univ. Medical Center (Netherlands). Dept. of Radiology); Pauwels, E.K.J. (Leiden Univ. Medical Center (Netherlands). Dept. of Radiology Leiden Univ. Medical Center (Netherlands). Division of Nuclear Medicine)

    1999-03-01

    In patients with rheumatoid arthritis (RA) synovitis activity is the dominant clinical variable that determines the therapeutic approach. At present, the amount of painful and swollen joint assessed by physical examination, is generally used to measure the degree of synovitis activity is not available. The availability of an objective and reproducible method to evaluate synovitis activity in RA would be of great value in patient management and in examination of therapeutic effects. An advantage of the use of radiopharmaceuticals in detection of arthritis activity, compared with other imaging techniques, is the possibility to depict all joints in a single image. Furthermore the technique may image joints which are difficult to assess clinically or radiographically and may also detect joint inflammation in an early phase. In this overview different scintigraphic techniques are compared with each other and with other diagnostic imaging modalities.

  3. The Danish nationwide clinical register for patients with rheumatoid arthritis

    DEFF Research Database (Denmark)

    Ibfelt, Else Helene; Jensen, Dorte Vendelbo; Hetland, Merete Lund

    2016-01-01

    Introduction: DANBIO is a research register and a data source for rheumatologic diseases (rheumatoid arthritis [RA], axial spondyloarthritis, and psoriatic arthritis) for monitoring clinical quality at the national, regional, and hospital levels. Study population: The register includes patients...... with rheumatologic diseases who are treated at a hospital or a private rheumatologic clinic. Registration is mandatory for all patients with RA regardless of treatment and also for patients with other diagnoses if treated with biological disease-modifying antirheumatic drugs. Since 2006, the registration has been...... the following: patient-reported outcomes for disease activity, pain, fatigue, functional status, and physician-reported objective measures of disease activity, treatment, C-reactive protein, and, when indicated, imaging. For subgroups of patients, the variables such as quality of life, sociodemographic factors...

  4. MR imaging assessment of clinical problems in rheumatoid arthritis

    Energy Technology Data Exchange (ETDEWEB)

    Narvaez, Jose A.; Roca, Yolanda; Aguilera, Carlos [Department of CT and MR Imaging, Hospital Duran i Reynals, Universitaria de Bellvitge, Barcelona (Spain); Narvaez, Javier [Department of Medicine, Delfos Medical Center, Barcelona (Spain)

    2002-07-01

    Although MR imaging has been increasingly recognized as a useful tool in the diagnosis of early rheumatoid arthritis (RA) and in the assessment of disease activity, these applications have not yet been usually included in the routine management of this condition. Our goal is to review the current role of MRI in the everyday clinical management of patients with RA. The usefulness of MRI in the evaluation of articular and para-articular changes in specific locations, mainly the craniocervical region and the temporomandibular joint, are reviewed. Clinical problems derived from local extra-articular involvement, such as tenosynovitis, ''rice-bodies'' bursitis, and Baker's cyst rupture, are also described. Finally, we also review the value of MRI in evaluation of some complications of RA such as tendinous rupture, osteonecrosis, stress fracture, and septic arthritis/osteomyelitis. (orig.)

  5. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol)

    Science.gov (United States)

    2014-01-01

    Cox regression models will estimate the risk of work cessation associated with the intervention after controlling for risk factors for WD and other important predictors imbalanced at baseline. Discussion This program fills an important gap in arthritis health services and addresses an important and costly problem. Knowledge gained from the RCT will be useful to health care professionals, policy planners and arthritis stakeholders. Trial registration ClinicalTrials.gov NCT01852851; registered April 13, 2012; first participant randomized on July 6, 2013. PMID:25043631

  6. Clinical presentation and treatment of septic arthritis in children.

    Science.gov (United States)

    Moro-Lago, I; Talavera, G; Moraleda, L; González-Morán, G

    The aim of this study is to determine the epidemiological features, clinical presentation, and treatment of children with septic arthritis. A retrospective review was conducted on a total of 141 children with septic arthritis treated in Hospital Universitario La Paz (Madrid) between the years 2000 to 2013. The patient data collected included, the joint affected, the clinical presentation, the laboratory results, the appearance, Gram stain result, and the joint fluid culture, as well as the imaging tests and the treatment. Most (94%) of the patients were less than 2 years-old. The most common location was the knee (52%), followed by the hip (21%). The septic arthritis was confirmed in 53%. No type of fever was initially observed in 49% of them, and 18% had an ESR (mm/h) or CRP (mg/l) less than 30 in the initial laboratory analysis. The joint fluid was purulent in 45% and turbid in 12%. The Gram stain showed bacteria in 4%. The fluid culture was positive in 17%. Staphylococcus aureus was the most common pathogen found, followed by Streptococcus agalactiae, Streptococcus pneumoniae, and Kingella kingae. Antibiotic treatment was intravenous administration for 7 days, followed by 21 days orally. Surgery was performed in 18% of cases. The diagnosis was only confirmed in 53% of the patients. Some of the confirmed septic arthritis did not present with the classical clinical/analytical signs, demonstrating that the traumatologist or paediatrician requires a high initial level of clinical suspicion of the disease. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

  7. 御米油软胶囊干预痛风性关节炎缓解期的临床试验研究%Clinical Trial on the Effects of Yumi Oil Soft Capsules on Gouty Arthritis Remission

    Institute of Scientific and Technical Information of China (English)

    马方励; 徐强; 林昌松

    2011-01-01

    Objective: To evaluate the impact of Yumi oil soft capsules on gouty arthritis remission. Method: Using random comparison method ,50 cases of gouty arthritis patients were divided into test group and control group, respectively. The observation period was 8 weeks. Arthralgia indices, VAS score of overall disease condition, body weight, blood pressure, uric acid ( UA), erythrocyte sedimentation rate (ESR) and lipids ( triglyceride and total cholesterol) as the main efficacy indices,nocturia,urinary frequency,urinary urgency and dysuria as the minor efficacy indices,and blood tests,urine tests,stool check,liver function,kidney function and blood sugar level as the main security indices,the effect of Yumi oil soft capsules on gouty arthritis remission was studied. Result: Between the two groups,there was no statistical difference in the minor efficacy indices,while there was significant statistical difference in the other indices,especially in the joint pain and the blood level of UA,ESR and lipids. Conclusion: Under the premise of keeping the existing treatment programs of gouty arthritis patients, Yumi oil soft capsules can significantly improve the total score of clinical symptoms, tenderness and pain VAS score and reduce the uric acid and total cholesterol levels in serum,which enhance the overall efficacy of the treatment programs of gouty arthritis patients.%目的:评价御米油软胶囊对痛风性关节炎缓解期的干预作用.方法:采用随机对照方法,50例痛风性关节炎患者随机分为试验组和对照组,观察8周,疗效评价以关节痛指标、疾病总体状况的VAS评分、体质量、血压、血尿酸值(UA)、血沉(ESR)及血脂(三酰甘油、总胆固醇)为主要疗效指标,夜尿、尿频、尿急及尿痛为次要疗效指标;血尿常规、大便检查、肝肾功能及血糖等指标为主要安全性指标.结果:试验组与对照组除夜尿、尿频、尿急及尿痛次要疗效指标差异无统计学意义外,

  8. Cardiovascular thrombotic events in arthritis trials of the cyclooxygenase-2 inhibitor celecoxib.

    Science.gov (United States)

    White, William B; Faich, Gerald; Borer, Jeffrey S; Makuch, Robert W

    2003-08-15

    To determine whether the cyclooxygenase-2 (COX-2) inhibitor celecoxib affects cardiovascular thrombotic risk, we analyzed the incidence of cardiovascular events for celecoxib, placebo, and nonsteroidal anti-inflammatory drugs (NSAIDs) in the entire controlled, arthritis clinical trial database for celecoxib. The primary analysis used the Antiplatelet Trialists' Collaboration end points, which include: (1) cardiovascular, hemorrhagic, and unknown deaths, (2) nonfatal myocardial infarction, and (3) nonfatal stroke. Other secondary thrombotic events were also examined. Separate analyses were performed for all patients and for those not taking aspirin. Data from all controlled, completed arthritis trials of > or =4 weeks duration, including 13 new drug application studies and 2 large post-marketing trials (CLASS and SUCCESS) were included for analyses. Patients were randomized to celecoxib at doses from 100 to 400 mg twice daily (18,942 patients; 5,668.2 patient-years of exposure), diclofenac 50 to 75 mg twice daily, ibuprofen 800 mg thrice daily, naproxen 500 mg twice daily (combined NSAID exposure of 11,143 patients; 3,612.2 patient-years), or placebo (1,794 subjects; 199.9 subject-years). Data from a long-term uncontrolled trial with 5,209 patients (6,950 patients-years) treated with celecoxib were included in a supplemental analysis. The entire 15-trial database was searched for possible serious thrombotic events as well as to identify all deaths. For these patients, detailed clinical data were obtained and reviewed by 2 of the investigators (WBW and JSB), who were independently and blinded to exposure, to classify the event as primary, secondary, or neither. All analyses were done using the intent-to-treat population, and time-to-event analyses were performed using per-patient data. To examine heterogeneity of results among studies, tests of interaction were performed using the Cox model. Incidences of the primary and secondary events were not significantly

  9. A Correlated Binary Model for Ignorable Missing Data: Application to Rheumatoid Arthritis Clinical Data.

    Science.gov (United States)

    Erebholo, Francis; Apprey, Victor; Bezandry, Paul; Kwagyan, John

    2016-04-01

    Incomplete data are common phenomenon in research that adopts the longitudinal design approach. If incomplete observations are present in the longitudinal data structure, ignoring it could lead to bias in statistical inference and interpretation. We adopt the disposition model and extend it to the analysis of longitudinal binary outcomes in the presence of monotone incomplete data. The response variable is modeled using a conditional logistic regression model. The nonresponse mechanism is assumed ignorable and developed as a combination of Markov's transition and logistic regression model. MLE method is used for parameter estimation. Application of our approach to rheumatoid arthritis clinical trials is presented.

  10. SMi's Conducting Clinical Trials in Europe.

    Science.gov (United States)

    Jago, Charlotte

    2009-12-01

    The Conducting Clinical Trials in Europe meeting, held in London, included topics covering new developments in the field of clinical trials and recommendations on how to best conduct a trial. This conference report highlights selected presentations on the state of affairs of trials in Europe, conducting trials in emerging markets, strategies for improving trials, trial design options, peri-approval and pediatric trials, and the role of key players, such as physicians. Company perspectives from Pfizer Inc and Nycomed are also included.

  11. Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  12. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... Care Apply Online Application Process Veteran Eligibility Active Duty Families of Veterans Women Veterans Determine Costs Copays ... VHA Forms & Publications Quality & Safety Quality of Care Ethics VA/DOD Clinical Practice Guidelines Access and Quality ...

  13. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2017-07-31

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  14. Patellofemoral pain, instability, and arthritis. Clinical presentation, imaging, and treatment

    Energy Technology Data Exchange (ETDEWEB)

    Zaffagnini, Stefano [Laboratorio di Biomeccanica, Bologna (Italy). Istituti Ortopedici Rizzoli; Dejour, David [Lyon-Ortho-Clinic (France). Knee Surgery Orthopaedic Dept.; Arendt, Elizabeth A. (eds.) [Minnesota Univ., Minneapolis, MN (United States). Dept. of Orthopaedics

    2010-07-01

    Despite numerous studies, a lack of consensus still exists over many aspects of patellofemoral pain, instability, and arthritis. This book adopts an evidence-based approach to assess each of these topics in depth. The book reviews general features of clinical examination and global evaluation techniques including the use of different imaging methods, e.g. x-rays, CT, MRI, stress x-rays, and bone scan. Various conservative and surgical treatment approaches for each of the three presentations - pain, instability, and arthritis - are then explained and assessed. Postoperative management and options in the event of failed surgery are also evaluated. Throughout, careful attention is paid to the literature in an attempt to establish the level of evidence for the efficacy of each imaging and treatment method. It is hoped that this book will serve as an informative guide for the practitioner when confronted with disorders of the patellofemoral joint. (orig.)

  15. Ankle tenosynovitis in rheumatoid arthritis: clinical and ultrasonographic evaluation

    Directory of Open Access Journals (Sweden)

    Ana Luiza Naves Pereira

    2016-11-01

    Full Text Available Objective: To investigate ankle tenosynovitis in rheumatoid arthritis patients, regarding its presence, the kind of tendon involved and the concordance between clinical and ultrasound findings. Methods: Twenty patients with rheumatoid arthritis and pain or swollen ankle joint were evaluated. Tendon involvement was evaluated with ultrasound imaging. The Health Assessment Questionnaire (HAQ was performed for disability evaluation. Age, sex, disease duration, and vocational activity levels were also obtained. The statistical analysis included Fisher’s exact test. The significance level was 0.05. Results: Tenosynovitis was found in 13 of 20 (65.0% patients in 19 joints, in which 6 were bilaterally (46.1% and unilateral in 7 (53.8%. Tibialis posterior tenosynovitis was seen in nine (45.0% patients, Achilles tenosynovitis in seven (35.0%, tibialis anterior tenosynovitis in three (15.0%, and peroneal tenosynovitis in three (15.0% patients. We found concordance between symptomatic ankle and ultrasonographic findings in 92.3% of the patients with tenosynovitis. Association between severe HAQ with tendon involvement was not found (p>0.05. Disease duration was not associated with tenosynovitis. Patients were predominantly older, female, with mean age around 50.8 years. The long disease duration of patients presented a mean of 11.4 years and, most of them, with no vocational activity (65.0%. Conclusions: The results indicate that ankle tenosynovitis is very common in rheumatoid arthritis patients, both unilateral and bilateral. Tibialis posterior was the most common tendon involvement found. Finally, we found concordance between the clinical and ultrasound findings in almost all rheumatoid arthritis patients with ankle tenosynovitis.

  16. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    BACKGROUND: Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. AIM: To assess the efficacy...... of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using......: In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21)....

  17. [Juvenil idiopathic arthritis. Part 1: diagnosis, pathogenesis and clinical manifestations].

    Science.gov (United States)

    Espada, Graciela

    2009-10-01

    Juvenile idiopathic arthritis is not a single disease and constitutes an heterogeneous group of illnesses or inflammatory disorders. This new nomenclature encompasses different disease categories, each of which has different presentation, clinical signs, symptoms, and outcome. The cause of the disease is still unknown but both environmental and genetic factors seem to be related to its pathogenesis. Is the most common chronic rheumatic disease in children and an important cause of short-term and long-term disability. In this article, clinical manifestation, new classification and approach to diagnosis are reviewed.

  18. CLINICAL AND FUNCTIONAL FEATURES OF PANCREAS STATE IN RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    O. O. Basieva

    2000-01-01

    Full Text Available Aim of study: complex pancreas study in rheumatoid arthritis (RA. Material and methods: 120 RA pts were examined clinically Pancreas US-and biochemical study (level of a-amylase and lipase of blood serum by kinetic-calorimetric method was performed in this grouh. Results: 50.8% of pts demonstrated increase of pancreas echo, in 23.3%- widened Wirsung s duct, in 45%- single small focal indurations, more often in the body and cauda pancreatis. Decrease of lipolitic and amylolytic pancreas activity is characteristic for RA, especially in systemic process and long-term disease. Clinical and functional disturbances are connected with morphological changes.

  19. Medical coding in clinical trials

    Directory of Open Access Journals (Sweden)

    Deven Babre

    2010-01-01

    Full Text Available Data generated in all clinical trial are recorded on the data collection instrument Case report Form / Electronic Case Report Form by investigators located at various sites in various countries. In multicentric clinical trials since different investigator or medically qualified experts are from different sites / centers recording the medical term(s uniformly is a big challenge. Medical coders from clinical data management team process these terms and perform medical coding. Medical coding is performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed. This article describes process which is used for medical coding in clinical data management and two most commonly used medical dictionaries MedDRA and WHO-DDE in brief. It is expected to help medical coders to understand the process of medical coding in clinical data management. Few common issues which the medical coder faces while performing medical coding, are also highlighted.

  20. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries

    Directory of Open Access Journals (Sweden)

    Codreanu C

    2015-01-01

    Full Text Available Catalin O Codreanu,1 Nemanja Damjanov2 1Rheumatology Department, Center of Rheumatic Diseases, Bucharest, Romania; 2Institute of Rheumatology, School of Medicine, University of Belgrade, Belgrade, SerbiaAbstract: Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA. Biologics selectively target components of the immune system, resulting in better disease control. However, the growing use of biologics in RA has increased safety concerns among rheumatologists. Randomized controlled trials (RCTs and registries are the most reliable sources of clinical safety data. Although safety data from RCTs provide certain insights into the clinical safety profile of an agent, strict constraints in study design (eg, exclusion criteria and restrictive treatment protocols often do not accurately reflect possible safety issues in the use of the agent, either in the clinical setting or over long-term treatment. Registries, on the other hand, are not restrictive regarding patient enrollment, making them more reliable in evaluating long-term safety. A number of registries have been established globally: in Europe, the United States, and Asia. However, the availability of registry data from Eastern Europe is lacking. The notable exceptions so far are registries from the Czech Republic (ATTRA, a registry of patients treated with anti-tumor necrosis factor-alpha drugs and Serbia (National registry of patients with rheumatoid arthritis in Serbia [NARRAS]. The current report provides an overview of safety data with biologics in RA from RCTs and registries. Availability of regional safety data from Eastern Europe is of great importance to its clinicians for making evidence-based treatment decisions in RA. Keywords: biologic therapy, biologic drugs, adverse events, infections, pregnancy, malignancies

  1. Methylsulfonylmethane and boswellic acids versus glucosamine sulfate in the treatment of knee arthritis: Randomized trial.

    Science.gov (United States)

    Notarnicola, Angela; Maccagnano, Giuseppe; Moretti, Lorenzo; Pesce, Vito; Tafuri, Silvio; Fiore, Alessandra; Moretti, Biagio

    2016-03-01

    Until now glucosamine sulfate (GS) has been the most widely used supplement and has been shown to be efficacious in the treatment of osteoarthritis (OA). Methylsulfonylmethane (MSM) and boswellic acids (BA) are new effective supplements for the management of inflammation and joint degeneration, according to previous experimental studies. The aim of our study is to test the effectiveness of association of MSM and BA in comparison with GS in knee arthritis.In this prospective randomized clinical trial, MEBAGA (Methylsulfonylmethane and Boswellic Acids versus Glucosamine sulfate in the treatment of knee Arthritis), 120 participants affected by arthritis of the knee were randomly assigned to an experimental group (MB group) or a control group (GS group) treated for 60 days with 5 g of MSM and 7.2 mg of BA or with 1500 mg of GS daily, respectively. At the 2-month (T1) and 6-months (T2) follow-up , the efficacy of these two nutraceuticals was assessed using the visual analog pain scale (VAS) and the Lequesne Index (LI) for joint function, along with the use of anti-inflammatory drugs (non-steroidal anti-inflammatory drugs and anti-cyclooxygenase-2).The repeated measures ANOVA analysis shows that for VAS, LI, and the use of anti-inflammatory drugs scores there are improvements due to the time in the two groups (respectively, F=26.0; P<0.0001; F=4.15; P=0.02; F=3.38; P=0.04), with a tendency to better values for the MB group at T2.On the basis of these preliminary data, we could support the efficacy of the MSM in association with BA in the treatment of OA. These results are consistent with the anti-inflammatory and chondroprotective effects previously occurred in experimental studies. This new combination of integration (MSM and BS) has presented good results and satisfactory in comparison with GS, until now the cornerstone of the treatment of arthritis in according to guidelines.

  2. [Reading a clinical trial report].

    Science.gov (United States)

    Bergmann, J F; Chassany, O

    2000-04-15

    To improve medical knowledge by reading clinical trial reports it is necessary to check for the respect of the methodological rules, and to analyze and criticize the results. A control group and a randomisation are always necessary. Double blind assessment, sample size calculation, intention to treat analysis, a unique primary end point are also important. The conclusions of the trial are valid only for the population included and the clinical signification of the results, depending on the control treatment, has to be evaluated. Respect of the reading rules is necessary to assess the reliability of the conclusions, in order to promote evidence-based practice.

  3. Innovations in clinical trials informatics.

    Science.gov (United States)

    Summers, Ron; Vyas, Hiten; Dudhal, Nilesh; Doherty, Neil F; Coombs, Crispin R; Hepworth, Mark

    2008-01-01

    This paper will investigate innovations in information management for use in clinical trials. The application typifies a complex, adaptive, distributed and information-rich environment for which continuous innovation is necessary. Organisational innovation is highlighted as well as the technical innovations in workflow processes and their representation as an integrated set of web services. Benefits realization uncovers further innovations in the business strand of the work undertaken. Following the description of the development of this information management system, the semantic web is postulated as a possible solution to tame the complexity related to information management issues found within clinical trials support systems.

  4. Improved early identification of arthritis : evaluating the efficacy of Early Arthritis Recognition Clinics

    NARCIS (Netherlands)

    van Nies, Jessica A. B.; Brouwer, Elisabeth; van Gaalen, Floris A.; Allaart, Cornelia F.; Huizinga, Tom W. J.; Posthumus, Marcel D.; van der Helm-van Mil, Annette H. M.

    Objective Only 31% of Dutch rheumatoid arthritis (RA)-patients visit a rheumatologist within 12weeks after symptom onset; this is mainly due to delay at the level of the general practitioner (GP). In order to reduce delay of GPs in identifying early arthritis, we initiated an Early Arthritis

  5. Clinical Trials in Your Community

    Science.gov (United States)

    The NCI Community Oncology Research Program (NCORP) is a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP conducts multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States and Puerto Rico.

  6. Glossary of Clinical Trials Terms

    Science.gov (United States)

    ... National Institutes of Health grant numbers. (See also Secondary IDs data element on ClinicalTrials.gov.) OUTCOME MEASURE A planned ... and Secondary Outcome Measure . (See also Primary and Secondary Outcome Measures data element and Outcome Measure results data element on ...

  7. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Questions to Ask about Your Diagnosis Research Cancer Treatment Types of Cancer Treatment Side Effects Clinical Trials Information A to Z ... Alternative Medicine (CAM) Questions to Ask about Your Treatment Research Coping with Cancer Feelings and Cancer Adjusting ...

  8. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Questions to Ask about Your Diagnosis Research Cancer Treatment Types of Cancer Treatment Side Effects Clinical Trials Information A to Z ... Alternative Medicine (CAM) Questions to Ask about Your Treatment Research Coping with Cancer Feelings and Cancer Adjusting ...

  9. Randomized Trial of Tocilizumab in Systemic Juvenile Idiopathic Arthritis

    NARCIS (Netherlands)

    De Benedetti, Fabrizio; Brunner, Hermine I.; Ruperto, Nicolino; Kenwright, Andrew; Wright, Stephen; Calvo, Inmaculada; Cuttica, Ruben; Ravelli, Angelo; Schneider, Rayfel; Woo, Patricia; Wouters, Carine; Xavier, Ricardo; Zemel, Lawrence; Baildam, Eileen; Burgos-Vargas, Ruben; Dolezalova, Pavla; Garay, Stella M.; Merino, Rosa; Joos, Rik; Grom, Alexei; Wulffraat, Nico; Zuber, Zbigniew; Zulian, Francesco; Lovell, Daniel; Martini, Alberto

    2012-01-01

    BACKGROUND Systemic juvenile idiopathic arthritis (JIA) is the most severe subtype of JIA; treatment options are limited. Interleukin-6 plays a pathogenic role in systemic JIA. METHODS We randomly assigned 112 children, 2 to 17 years of age, with active systemic JIA (duration of >= 6 months and inad

  10. Clinical measures in rheumatoid arthritis and ankylosing spondylitis.

    Science.gov (United States)

    Fendler, C; Braun, J

    2009-01-01

    Except for morning stiffness, the clinical symptoms and the history of patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) usually differ: the location in RA is mostly the hands and feet, and in AS rather the back. Patients with RA tend to be older (>50 years) and female, while in AS there are somewhat more often male and younger (physical examens, a reduction of lateral spinal flexion and chest expansion are often the earliest signs which are also sensitive to change on therapy with biologics. The cervical spine may be affected in RA and AS - more frequently in advanced disease stages but rather early cases have been reported.

  11. Clinical and immunological features of early rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    N A Shostak

    2004-01-01

    Full Text Available Objective. To study clinical and immunological features of rheumatoid arthritis (RA early stage. Material and Methods. 130 RA pts aged 16 to 80 years (mean age 52,5 years, 105 female and 25 male were examined. 55 pts had disease duration up to 1 year, 34 - between 1 and 3 years and 41 - more than 3 years. Standard clinical, laboratory and radiological examination was performed in all pts. In 43 pts with earlv RA T and В cell receptors were studied with monoclonal antibodies against CD3, CD72, CD4, CD8, CDI6. Results. The most frequent initial symptoms preceding characteristic RA picture were arthralgia (39,2%, fever (34,6% and body weight loss (24,6%. Mono- or oligoarticuiar onset with subsequent quick transformation into polyarthritis within one year revealed in 61,5% of pts was the usual feature of early RA. The most frequent false diagnoses in early RA were osteoarthritis (in 25,1%, reactive arthritis (in 24,9% and gout (in 4,6%. Male pts had longer morning stiffness, higher levels of C-reactive protein, more pronounced functional disability, T and В cell immunity activation than female. Conclusion. Understanding of essential clinical and immunologic features of early RA will allow to diagnose the disease in time.

  12. The Effects of Aromatherapy Massage and Reflexology on Pain and Fatigue in Patients with Rheumatoid Arthritis: A Randomized Controlled Trial.

    Science.gov (United States)

    Gok Metin, Zehra; Ozdemir, Leyla

    2016-04-01

    Nonpharmacologic interventions for symptom management in patients with rheumatoid arthritis are underinvestigated. Limited data suggest that aromatherapy massage and reflexology may help to reduce pain and fatigue in patients with rheumatoid arthritis. The aim of this study was to examine and compare the effects of aromatherapy massage and reflexology on pain and fatigue in patients with rheumatoid arthritis. The study sample was randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in the first intervention group for 30 minutes. Reflexology was administered to both feet of subjects in the second intervention group for 40 minutes during weekly home visits. Control group subjects received no intervention. Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this randomized controlled trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks. Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p massage and reflexology are simple and effective nonpharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis.

  13. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    Directory of Open Access Journals (Sweden)

    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  14. Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Eichas Katy

    2010-01-01

    Full Text Available Abstract Background Lactic acid-producing bacteria (LAB probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA in combination with pharmacological anti-arthritic medications. Methods Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI, and laboratory tests for erythrocyte sedimentation rate (ESR and C-reactive protein (CRP. Results Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052 and statistically significant improvement in Pain Scale (P = .046 vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Conclusions Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. Trial registration ACTRN12609000435280

  15. Clinical trials on AIDS start.

    Science.gov (United States)

    A 6-month clinical trial in the Philippines sought to determine the efficacy of coconut oil and of "monolaurin," a coconut oil byproduct, in killing HIV by breaking down its coating. This research is based on the theory that medium-chain fatty acids, like monolaurin, can have this effect on certain viruses. The trial involves 12 women and 3 men in the early stage of HIV infection. 10 patients will take different doses of monolaurin, and 5 will consume coconut oil. It is hypothesized that the regimen will lead to higher CD4 counts and a lower viral load. The trial was almost abandoned because it received only lukewarm approval from the Health Secretary.

  16. Clinical Trials in Noninfectious Uveitis

    Science.gov (United States)

    Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida

    2015-01-01

    The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763

  17. INFLUENCE OF PHYSIOTHERAPY ON CLINICAL AND IMMUNOLOGICAL PARAMETERS IN CHILDREN WITH JUVENILE RHEUMATOID ARTHRITIS

    OpenAIRE

    T.L. Nastausheva; L.T. Dmitrieva

    2008-01-01

    Clinical and immunological status has been evaluated in 85 children with juvenile rheumatoid arthritis (RA) before and after physiotherapeutic procedures: electrophoresis with dimexid and magnetotherapy. The control group of 31 children did not follow physiotherapeutic procedures. The following results were fixed: clinical indices and immunological status of children with juvenile rheumatoid arthritis have been changed in a larger degree in case of magnetotherapy.

  18. Clinical potential of apremilast in the treatment of psoriatic arthritis

    Directory of Open Access Journals (Sweden)

    Cauli A

    2014-06-01

    Full Text Available Alberto Cauli, Giovanni Porru, Matteo Piga, Alessandra Vacca, Grazia Dessole, Alessandro MathieuRheumatology Unit, Department of Medical Sciences, Policlinico of University of Cagliari, Monserrato, ItalyAbstract: Psoriatic arthritis (PsA is a frequent chronic inflammatory disease characterized by joint and skin involvement, and by typical extra-articular manifestations. Although the pathogenesis of PsA is still under investigation, the available evidence suggests the importance of the patient's genetic background, microbial or environmental triggers, and an imbalance in the adaptive and acquired immune system, resulting in the production of inflammatory mediators. New therapeutic approaches have been proposed, among them the use of modulators of intracellular signals and gene transcription such as PDE4-inhibiting compounds, which are able to modulate the activity of transcription factors such as CREB and NF-κB and therefore the synthesis of inflammatory mediators, resulting in immunoregulation. This paper summarizes the mechanism of action of apremilast, a PDE4 inhibitor, and the clinical data available on its clinical efficacy and safety profile in the treatment of PsA patients.Keywords: psoriatic arthritis, apremilast, therapy

  19. Effect of improving depression care on pain and functional outcomes among older adults with arthritis: a randomized controlled trial.

    Science.gov (United States)

    Lin, Elizabeth H B; Katon, Wayne; Von Korff, Michael; Tang, Lingqi; Williams, John W; Kroenke, Kurt; Hunkeler, Enid; Harpole, Linda; Hegel, Mark; Arean, Patricia; Hoffing, Marc; Della Penna, Richard; Langston, Chris; Unützer, Jürgen

    2003-11-12

    Depression and arthritis are disabling and common health problems in late life. Depression is also a risk factor for poor health outcomes among arthritis patients. To determine whether enhancing care for depression improves pain and functional outcomes in older adults with depression and arthritis. Preplanned subgroup analyses of Improving Mood-Promoting Access to Collaborative Treatment (IMPACT), a randomized controlled trial of 1801 depressed older adults (> or =60 years), which was performed at 18 primary care clinics from 8 health care organizations in 5 states across the United States from July 1999 to August 2001. A total of 1001 (56%) reported coexisting arthritis at baseline. Antidepressant medications and/or 6 to 8 sessions of psychotherapy (Problem-Solving Treatment in Primary Care). Depression, pain intensity (scale of 0 to 10), interference with daily activities due to arthritis (scale of 0 to 10), general health status, and overall quality-of-life outcomes assessed at baseline, 3, 6, and 12 months. In addition to reduction in depressive symptoms, the intervention group compared with the usual care group at 12 months had lower mean (SE) scores for pain intensity (5.62 [0.16] vs 6.15 [0.16]; between-group difference, -0.53; 95% confidence interval [CI], -0.92 to -0.14; P =.009), interference with daily activities due to arthritis (4.40 [0.18] vs 4.99 [0.17]; between-group difference, -0.59; 95% CI, -1.00 to -0.19; P =.004), and interference with daily activities due to pain (2.92 [0.07] vs 3.17 [0.07]; between-group difference, -0.26; 95% CI, -0.41 to -0.10; P =.002). Overall health and quality of life were also enhanced among intervention patients relative to control patients at 12 months. In a large and diverse population of older adults with arthritis (mostly osteoarthritis) and comorbid depression, benefits of improved depression care extended beyond reduced depressive symptoms and included decreased pain as well as improved functional status and

  20. The ethics of clinical trials

    Science.gov (United States)

    Nardini, Cecilia

    2014-01-01

    Over the past decades, randomised controlled trials (RCTs) have prevailed over clinical judgement, case reports, and observational studies and became the gold evidential standard in medicine. Furthermore, during the same time frame, RCTs became a crucial part of the regulatory process whereby a new therapeutic can gain access to the drug market. Today, clinical trials are large and tightly regulated enterprises that have to comply with ethical requirements while maintaining high epistemic standards, a balance that becomes increasingly difficult as the research questions become more sophisticated. In this review, the author will discuss some of the most important ethical issues surrounding RCTs, with an eye to the most recent debates and the context of oncological research in particular. PMID:24482672

  1. Clinical Trials: Key to Medical Progress

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: Key to Medical Progress Past Issues / Summer 2008 ... this page please turn Javascript on. Photo iStock Clinical trials are research studies that test how well new ...

  2. Clinical trials in neurology: design, conduct, analysis

    National Research Council Canada - National Science Library

    Ravina, Bernard

    2012-01-01

    .... Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases...

  3. Comparison of clinical and biologic features of Kingella kingae and Staphylococcus aureus arthritis at initial evaluation.

    Science.gov (United States)

    Basmaci, Romain; Lorrot, Mathie; Bidet, Philippe; Doit, Catherine; Vitoux, Christine; Penneçot, Georges; Mazda, Keyvan; Bingen, Edouard; Ilharreborde, Brice; Bonacorsi, Stéphane

    2011-10-01

    We conducted a retrospective study comparing the presenting clinical and biologic features of 64 children who had septic arthritis caused by Kingella kingae with 26 children who had septic arthritis caused by Staphylococcus aureus. Children with K. kingae septic arthritis were significantly younger than those with S. aureus septic arthritis. Otherwise, there were no significant differences between the 2 groups with respect to fever, location, white blood cell count, synovial fluid cell count, C-reactive protein, or serum fibrinogen. However, the clinical course was significantly better for children with septic arthritis caused by K. kingae as evidenced by shorter hospitalization and fewer adverse events. Presumptive antibiotic therapy for septic arthritis in young infants should take into account both of these pathogens, even in case of mild presentation.

  4. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  5. Imaging in the diagnosis and management of peripheral psoriatic arthritis-The clinical utility of magnetic resonance imaging and ultrasonography

    DEFF Research Database (Denmark)

    Østergaard, Mikkel; Eder, Lihi; Christiansen, Sara Nysom

    2016-01-01

    Psoriatic arthritis (PsA) is an inflammatory joint disease characterised by the presence of arthritis and often enthesitis and/or spondylitis in patients with psoriasis. However, it presents a wide range of disease manifestations in various patterns. Imaging is an important part of management of ......A. In contrast to MRI, US is not useful for assessing axial involvement in the spine and sacroiliac joints. In this paper, we will provide an overview of the status, strengths and limitations of MRI and US in peripheral PsA in routine clinical practice and clinical trials.......A, and is used for multiple reasons including establishing/confirming a diagnosis of inflammatory joint disease, determining the extent of disease, monitoring activity and damage, assessing therapeutic efficacy, and identifying complications of disease or treatment, in the setting of clinical practice...

  6. Uveitis in juvenile chronic arthritis: incidence, clinical features and prognosis.

    Science.gov (United States)

    Kanski, J J

    1988-01-01

    Three hundred and fifteen patients with anterior uveitis and juvenile chronic arthritis were reviewed in order to determine the incidence, visual prognosis, and the clinical characteristics of the intraocular inflammation. The overall incidence of uveitis was 20%. Approximately 25% of patients had relatively mild and/or transient involvement and an excellent visual prognosis. In 50% the uveitis was more severe but could be controlled with topical medication. In the remaining 25% the visual prognosis was poor due to the intractable nature of the uveitis and the subsequent development of vision-threatening complications. The majority of patients (74%) were under the age of 8 years when the uveitis was first diagnosed. Clinically, the intraocular inflammation was most frequently an asymptomatic, chronic, non-granulomatous, iridocyclitis which was bilateral in 71% of cases. Other ocular lesions, which were rare, included keratoconjunctivitis sicca and corneal melting.

  7. Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation: 2-year results of the C-OPERA study, a phase III randomised trial.

    Science.gov (United States)

    Atsumi, Tatsuya; Tanaka, Yoshiya; Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Yasuda, Shinsuke; Yamanishi, Yuji; Kita, Yasuhiko; Matsubara, Tsukasa; Iwamoto, Masahiro; Shoji, Toshiharu; Togo, Osamu; Okada, Toshiyuki; van der Heijde, Désirée; Miyasaka, Nobuyuki; Koike, Takao

    2017-08-01

    To investigate the clinical impact of 1-year certolizumab pegol (CZP) therapy added to the first year of 2-year methotrexate (MTX) therapy, compared with 2-year therapy with MTX alone. MTX-naïve patients with early rheumatoid arthritis (RA) with poor prognostic factors were eligible to enter Certolizumab-Optimal Prevention of joint damage for Early RA (C-OPERA), a multicentre, randomised, controlled study, which consisted of a 52-week double-blind (DB) period and subsequent 52-week post treatment (PT) period. Patients were randomised to optimised MTX+CZP (n=159) or optimised MTX+placebo (PBO; n=157). Following the DB period, patients entered the PT period, receiving MTX alone (CZP+MTX→MTX; n=108, PBO+MTX→MTX; n=71). Patients who flared could receive rescue treatment with open-label CZP. 34 CZP+MTX→MTX patients and 14 PBO+MTX→MTX patients discontinued during the PT period. From week 52 through week 104, significant inhibition of total modified total Sharp score progression was observed for CZP+MTX versus PBO+MTX (week 104: 84.2% vs 67.5% (p<0.001)). Remission rates decreased after CZP discontinuation; however, higher rates were maintained through week 104 in CZP+MTX→MTX versus PBO+MTX→MTX (41.5% vs 29.3% (p=0.026), 34.6% vs 24.2% (p=0.049) and 41.5% vs 33.1% (p=0.132) at week 104 in SDAI, Boolean and DAS28(erythrocyte sedimentation rate) remission. CZP retreated patients due to flare (n=28) showed rapid clinical improvement. The incidence of overall adverse events was similar between groups. In MTX-naïve patients with early RA with poor prognostic factors, an initial 1 year of add-on CZP to 2-year optimised MTX therapy brings radiographic and clinical benefit through 2 years, even after stopping CZP. NCT01451203. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. [Septic arthritis in children with normal initial C-reactive protein: clinical and biological features].

    Science.gov (United States)

    Basmaci, R; Ilharreborde, B; Bonacorsi, S; Kahil, M; Mallet, C; Aupiais, C; Doit, C; Dugué, S; Lorrot, M

    2014-11-01

    Septic arthritis has to be suspected in children with joint effusion and fever so as to perform joint aspiration, which will confirm the diagnosis by bacteriological methods, and to perform surgical treatment by joint lavage. Since development of current molecular methods, such as real-time PCR, Kingella kingae has become the first microbial agent of osteoarticular infections in young children, whereas Staphylococcus aureus is second. C-reactive protein (CRP) is an aid used to diagnose septic arthritis, but its elevation could be moderate. In a previous study, conducted at our hospital, 10% of children hospitalized for S. aureus or K. kingae septic arthritis had a CRP levelseptic arthritis could be made by other parameters, we analyzed the clinical and biologic features of these patients and compared them to those of children hospitalized for septic arthritis with initial CRP ≥10 mg/L. Among the 89 children with septic arthritis, 10% (n=9) had initial CRPkingae, n=5/63 ; S. aureus, n=4/26). Initial temperature and fibrinogen were significantly lower in the CRPseptic arthritis had no fever, CRP elevation, or fibrinogen elevation. In the CRP-negative group, three of four children with S. aureus arthritis and one of five with K. kingae arthritis had a high CRP level (34, 40, 61, and 13 mg/L, respectively) 3 days after surgery and antibiotic treatment. One child with K. kingae septic arthritis and initial CRParthritis. In the S. aureus arthritis group, none of the children with initial CRP10 mg/L during septic arthritis in children, it could be negative in up to 20% of patients in different studies. However, a mild inflammatory syndrome or even a CRPseptic arthritis. Therefore, a first episode of monoarthritis in children has to be considered as septic arthritis and treatment should not be delayed.

  9. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  10. Clinical predictors of temporomandibular joint arthritis in juvenile idiopathic arthritis: A systematic literature review.

    Science.gov (United States)

    Kristensen, Kasper Dahl; Stoustrup, Peter; Küseler, Annelise; Pedersen, Thomas Klit; Twilt, Marika; Herlin, Troels

    2016-06-01

    To assess the level of evidence for subjective and objective parameters in clinical orofacial examination and determine if predictors for temporomandibular joint (TMJ) involvement in juvenile idiopathic arthritis (JIA) patients exist in the current literature. A comprehensive systematic electronic search strategy was performed in all major medical databases in June 2015. Studies were selected independently by two reviewers in accordance with a prespecified protocol and a risk of bias assessment for all included studies. Subjective examination outcome measures assessed were pain, decreased TMJ function, and TMJ sounds. The objective outcome measures assessed were maximal incisor opening, mandibular asymmetric opening, condylar translation, protrusion, myofascial pain on palpation, facial asymmetry, and micro- or retrognathism. The electronic database search identified 345 unique citations. After application of our strict, predefined inclusion and exclusion criteria, 21 articles were included and data extracted. The study heterogeneity did not allow for meta-analyses. No singular outcome measure can be suggested as a predictor of TMJ involvement in JIA, as sensitivity and/or specificity is too low compared to contrast-enhanced magnetic resonance imaging. The current low level of evidence and study heterogeneity do not allow us to conclude on singular clinical outcome measures. To increase study comparability, we call for a standardized terminology and evidence-based guidelines for clinical orofacial examination parameters in JIA patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Maintenance of Clinical and Radiographic Benefit With Intravenous Golimumab Therapy in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week-112 Efficacy and Safety Results of the Open-Label Long-Term Extension of a Phase III, Double-Blind, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Bingham, Clifton O; Mendelsohn, Alan M; Kim, Lilianne; Xu, Zhenhua; Leu, Jocelyn; Han, Chenglong; Lo, Kim Hung; Westhovens, Rene; Weinblatt, Michael E

    2015-12-01

    To evaluate the safety, efficacy, pharmacokinetics, immunogenicity, and radiographic progression through 2 years of treatment with intravenous (IV) golimumab plus methotrexate (MTX) in an open-label extension of a phase III trial of patients with active rheumatoid arthritis (RA) despite MTX therapy. In the phase III, double-blind, randomized, placebo-controlled GO-FURTHER trial, 592 patients with active RA were randomized (2:1) to intravenous golimumab 2 mg/kg plus MTX (Group 1) or placebo plus MTX (Group 2) at weeks 0 and 4, then every 8 weeks thereafter; placebo patients crossed over to golimumab at week 16 (early escape) or week 24 (crossover). The final golimumab infusion was at week 100. Assessments included American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) response criteria, 28-joint count disease activity score using the C-reactive protein level (DAS28-CRP), physical function and quality of life measures, and changes in the modified Sharp/van der Heijde scores (SHS). Safety was monitored through week 112. In total, 486 patients (82.1%) continued treatment through week 100, and 68.1%, 43.8%, and 23.5% had an ACR20/50/70 response, respectively, at week 100. Clinical response and improvements in physical function and quality of life were generally maintained from week 24 through 2 years. Mean change from baseline to week 100 in SHS score was 0.74 in Group 1 and 2.10 in Group 2 (P = 0.005); progression from week 52 to week 100 was clinically insignificant in both groups. A total of 481 patients completed the safety followup through week 112; 79.1% had an adverse event, and 18.2% had a serious adverse event. Clinical response to IV golimumab plus MTX was maintained through week 100. Radiographic progression following golimumab treatment was clinically insignificant between week 52 and week 100. No unexpected adverse events occurred through week 112, and the safety profile was consistent with anti-tumor necrosis factor therapy. © 2015 The

  12. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were......, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  13. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C

    2016-07-01

    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  14. Clinical utility of the oral JAK inhibitor tofacitinib in the treatment of rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Cutolo M

    2013-11-01

    Full Text Available Maurizio Cutolo, Marianna Meroni Research Laboratories and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Genova, Italy Abstract: Immune/inflammatory cells act in rheumatoid arthritis (RA-affected patients by synthesizing several inflammatory mediators, including cytokines that initiate intracellular signaling. Recently, small molecule inhibitors of transduction and transcription signals that influence the intracellular pathways (such as the Janus kinase [JAK] family of tyrosine kinases have been tested for RA treatment. Four members of the JAK family are known: JAK1, JAK2, JAK3, and TyK2. JAK1/JAK3 constitutively binds to the cytoplasmic portion of the cytokine receptor – the common gamma chain – that represents a common subunit of several cytokines involved in T-cell and natural killer cell development, as well as in B-cell activation. Tofacitinib is an oral JAK inhibitor that is now available and effective in RA treatment, as shown in multiple Phase II and Phase III clinical trials. However, long-term safety data and comparisons with other disease-modifying antirheumatic drugs and small molecule inhibitors are necessary to better determine the role of tofacitinib in RA. Keywords: Janus kinase inhibitors, tofacitinib, rheumatoid arthritis, kinases, small molecules inhibitors, intracellular signaling

  15. 78 FR 17679 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Closed Meeting

    Science.gov (United States)

    2013-03-22

    ... HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and... Musculoskeletal and Skin Diseases Special Emphasis Panel; NIAMS Clinical Trial Outcome Development. Date: March 29...., Scientific Review Officer, Scientific Review Branch, National Institute of Arthritis, Musculoskeletal...

  16. 77 FR 64814 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting

    Science.gov (United States)

    2012-10-23

    ... HUMAN SERVICES National Institutes of Health National Institute of Arthritis and Musculoskeletal and... Musculoskeletal and Skin Diseases Special Emphasis Panel; NIAMS clinical trial and planning grant applications in... Review Officer, National Institute of Arthritis, Musculoskeletal and Skin Diseases, National...

  17. Clinical Aspects of Pregnancy-induced Amelioration of Rheumatoid Arthritis: PARA-study

    NARCIS (Netherlands)

    Y.A. de Man (Yael)

    2009-01-01

    textabstractIn this PhD thesis, embedded in the PARA (Pregnancy-induced Amelioration of Rheumatoid Arthritis) study, several clinical aspects of the spontaneously occurring pregnancy-induced improvement of rheumatoid arthritis (RA) are addressed. An overview is given of inflammatory rheumatic disea

  18. a randomized controlled clinical trial

    OpenAIRE

    2013-01-01

    In this study we aimed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a randomized clinical trial. 77 with chronic neck pain who scored > 40 mm on a 100-mm visual analog scale (VAS) were randomized to a nine week Iyengar yoga program with weekly 90-minute classes or to a self-care/exercise program. The primary outcome measure was change of mean pain at rest (VAS) from baseline to week ten. Secondary outcomes included pain at motion, functional disabilit...

  19. Contrast-enhanced MRI of the knee in children unaffected by clinical arthritis compared to clinically active juvenile idiopathic arthritis patients

    Energy Technology Data Exchange (ETDEWEB)

    Nusman, Charlotte M.; Hemke, Robert [University of Amsterdam, Department of Radiology, Academic Medical Center, Amsterdam (Netherlands); University of Amsterdam, Department of Pediatric Hematology, Immunology, Rheumatology and Infectious Disease, Emma Children' s Hospital AMC, Amsterdam (Netherlands); Benninga, Marc A.; Kindermann, Angelika [University of Amsterdam, Department of Pediatric Gastroenterology, Emma Children' s Hospital AMC, Amsterdam (Netherlands); Schonenberg-Meinema, Dieneke; Berg, J.M. van den; Kuijpers, Taco W. [University of Amsterdam, Department of Pediatric Hematology, Immunology, Rheumatology and Infectious Disease, Emma Children' s Hospital AMC, Amsterdam (Netherlands); Rossum, Marion A.J. van [University of Amsterdam, Department of Pediatric Hematology, Immunology, Rheumatology and Infectious Disease, Emma Children' s Hospital AMC, Amsterdam (Netherlands); Reade, Department of Pediatric Rheumatology, Amsterdam (Netherlands); Maas, Mario [University of Amsterdam, Department of Radiology, Academic Medical Center, Amsterdam (Netherlands)

    2016-04-15

    To evaluate enhancing synovial thickness upon contrast-enhanced magnetic resonance imaging (MRI) of the knee in children unaffected by clinical arthritis compared with clinically active juvenile idiopathic arthritis (JIA) patients. A secondary objective was optimization of the scoring method based on maximizing differences on MRI between these groups. Twenty-five children without history of joint complaints nor any clinical signs of joint inflammation were age/sex-matched with 25 clinically active JIA patients with arthritis of at least one knee. Two trained radiologists, blinded for clinical status, independently evaluated location and extent of enhancing synovial thickness with the validated Juvenile Arthritis MRI Scoring system (JAMRIS) on contrast-enhanced axial fat-saturated T1-weighted MRI of the knee. Enhancing synovium (≥2 mm) was present in 13 (52 %) unaffected children. Using the total JAMRIS score for synovial thickening, no significant difference was found between unaffected children and active JIA patients (p = 0.091). Additional weighting of synovial thickening at the JIA-specific locations enabled more sensitive discrimination (p = 0.011). Mild synovial thickening is commonly present in the knee of children unaffected by clinical arthritis. The infrapatellar and cruciate ligament synovial involvement were specific for JIA, which - in a revised JAMRIS - increases the ability to discriminate between JIA and unaffected children. (orig.)

  20. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  1. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...

  2. Clinical trials: innovation, progress and controversy

    Directory of Open Access Journals (Sweden)

    Martin GS

    2011-08-01

    Full Text Available Greg S MartinDepartment of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, Georgia, USAThe Open Access Journal of Clinical Trials began in 2009 with the goal of being an authoritative, open access source for international, peer-reviewed publications in the field of human research and clinical trials. Since then, the Open Access Journal of Clinical Trials has published approximately 30 high-quality articles on original research, innovative reviews, and critical commentaries. These articles have spanned many aspects of clinical trials wonderfully, including trial design and management; legal, ethical and regulatory issues of clinical trials; subject participation and retention in clinical trials; and data collection and data management.

  3. Bayesian adaptive methods for clinical trials

    CERN Document Server

    Berry, Scott M; Muller, Peter

    2010-01-01

    Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISP...

  4. The rheumatoid arthritis treat-to-target trial: a cluster randomized trial within the Corrona rheumatology network.

    Science.gov (United States)

    Harrold, Leslie R; Reed, George W; Harrington, J Timothy; Barr, Christine J; Saunders, Katherine C; Gibofsky, Allan; Greenberg, Jeffrey D; John, Ani; Devenport, Jenny; Kremer, Joel M

    2014-11-21

    The treat-to-target (T2T) approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity, frequent follow-up visits for patients with moderate to high disease activity, and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores. The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices. It is designed to identify patient and provider barriers to implementing T2T management. This initial paper focuses on the novel study design and methods created to provide these insights. This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T2T or usual care (UC) for qualified patients who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity. Specific medication choices are left to the investigator and patient, rather than being specified in the protocol. Enrollment is expected to be completed by the end of 2013, with 30 practices randomized and enrolling a minimum of 530 patients. During the 12-month follow-up, visits are mandated as frequently as monthly in patients with active disease in the T2T group and every 3 months for the UC group. Safety data are collected at each visit. The coprimary endpoints include a comparison of the proportion of patients achieving low disease activity in the T2T and UC groups and assessment of the feasibility of implementing T2T in rheumatology practices, specifically assessment of the rates of treatment acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity in the 2 groups. This

  5. Baricitinib in rheumatoid arthritis: evidence-to-date and clinical potential

    Science.gov (United States)

    Kuriya, Bindee; Cohen, Marc D.; Keystone, Ed

    2017-01-01

    Biologics have changed expectation and outcomes for rheumatoid arthritis (RA). However, the optimal duration and sequence of therapy for this disease has yet to be determined. Also, a significant number of patients do not satisfactorily respond to currently available therapies. The Janus kinase (JAK) inhibitors represent a new class of therapies for RA. These drugs work uniquely by inhibiting intracellular pathways thought to be important in the pathogenesis of RA. They are available as oral agents, which is also different from the currently available biologics. Baricitinib has now been evaluated in four phase III clinical trials, and although safety concerns cannot fully be answered until the drug is studied over longer periods of time, the data to date suggest that this drug with its once daily dosing, rapid onset of action and efficacy as monotherapy represents an important addition to the RA therapeutic armamentarium. Further study and experience will better define how baricitinib will be used and by which patients. PMID:28255337

  6. Clinical features of rheumatoid arthritis-associated interstitial lung disease.

    Science.gov (United States)

    Wang, Ting; Zheng, Xing-Ju; Liang, Bin-Miao; Liang, Zong-An

    2015-10-07

    Interstitial lung disease (ILD) is the most common extra-articular manifestations of rheumatoid arthritis (RA) in the lung. This study aimed to identify clinical features of RA-associated ILD (RA-ILD). Patients with RA were retrospectively enrolled and sub-classified as RA-ILD or RA without ILD based on high-resolution computed tomography imaging. Pulmonary function testing parameters and levels of RA-related biomarkers, tumour markers, and acute-phase proteins were compared between the two groups. Logistic regression model was used to assess the strength of association between RA-ILD and clinical features of interest. Receiver operating characteristic analysis was performed to assess potential predictive value of clinical features for detecting RA-ILD. Comparison analysis indicated that the percentage of predicted value of total lung capacity, inspiratory capacity, and diffusion capacity of the lung for carbon monoxide (DLCO) were reduced in patients with RA-ILD. Tumour markers CA15-3 and CA125 were increased in patients with RA-ILD. Logistic regression analysis revealed that decreased DLCO was related to the increased likelihood of RA-ILD (OR = 0.94, 95%CI = [0.91, 0.98]). The cut-off point at 52.95 percent of predicted value could sensitively discriminate RA patients with or without ILD. Our study suggested that DLCO value could be a useful tool for detecting ILD in patients with RA.

  7. From clinical expert to guide: experiences from coaching people with rheumatoid arthritis to increased physical activity.

    Science.gov (United States)

    Nessen, Thomas; Opava, Christina H; Martin, Cathrin; Demmelmaier, Ingrid

    2014-05-01

    Physical activity levels in people with rheumatoid arthritis are lower than what are recommended for a healthful lifestyle. To support physical activity, health care professionals may use behavioral change techniques based on a biopsychosocial perspective. Investigating the implementation process may be relevant for understanding how these techniques translate to practice. The study objective was to explore the experiences of physical therapists using behavioral change techniques to coach people with rheumatoid arthritis to health-enhancing physical activity in a 2-year trial, the Physical Activity in Rheumatoid Arthritis 2010 study. This was an exploratory study with qualitative content analysis. Semistructured interviews were conducted with all 12 physical therapists in the study. They were asked about their experiences with an educational program and with their delivery of a health-enhancing physical activity intervention. Codes, subcategories, categories, and an overarching theme were derived from the transcribed interviews by use of qualitative content analysis. The overarching theme (from clinical expert to guide) was based on 3 main categories: challenges in the coaching role, growing into the coaching role, and coach education and support. Early in the process, the physical therapists encountered challenges that needed to be addressed for a smoother transition into their coaching role. Assisted by education and support, they gradually adopted practices that facilitated their use of behavioral change techniques and promoted growth into the role of coach. Adapting to a new role is a challenging process for health care professionals; it requires relevant education and support. The experiences identified in the present study may inform future educational programs targeting the skills of health care professionals in promoting various health-related behaviors.

  8. The state of infectious diseases clinical trials: a systematic review of ClinicalTrials.gov.

    Science.gov (United States)

    Goswami, Neela D; Pfeiffer, Christopher D; Horton, John R; Chiswell, Karen; Tasneem, Asba; Tsalik, Ephraim L

    2013-01-01

    There is a paucity of clinical trials informing specific questions faced by infectious diseases (ID) specialists. The ClinicalTrials.gov registry offers an opportunity to evaluate the ID clinical trials portfolio. We examined 40,970 interventional trials registered with ClinicalTrials.gov from 2007-2010, focusing on study conditions and interventions to identify ID-related trials. Relevance to ID was manually confirmed for each programmatically identified trial, yielding 3570 ID trials and 37,400 non-ID trials for analysis. The number of ID trials was similar to the number of trials identified as belonging to cardiovascular medicine (n = 3437) or mental health (n = 3695) specialties. Slightly over half of ID trials were treatment-oriented trials (53%, vs. 77% for non-ID trials) followed by prevention (38%, vs. 8% in non-ID trials). ID trials tended to be larger than those of other specialties, with a median enrollment of 125 subjects (interquartile range [IQR], 45-400) vs. 60 (IQR, 30-160) for non-ID trials. Most ID studies are randomized (73%) but nonblinded (56%). Industry was the funding source in 51% of ID trials vs. 10% that were primarily NIH-funded. HIV-AIDS trials constitute the largest subset of ID trials (n = 815 [23%]), followed by influenza vaccine (n = 375 [11%]), and hepatitis C (n = 339 [9%]) trials. Relative to U.S. and global mortality rates, HIV-AIDS and hepatitis C virus trials are over-represented, whereas lower respiratory tract infection trials are under-represented in this large sample of ID clinical trials. This work is the first to characterize ID clinical trials registered in ClinicalTrials.gov, providing a framework to discuss prioritization, methodology, and policy.

  9. [Profile of clinical trials enrolling Brazilian children].

    Science.gov (United States)

    Vieira, Jean Mendes de Lucena; Lima, Elisangela da Costa; Land, Marcelo Gerardin Poirot; Ventura, Miriam; Coelho, Helena Lutescia Luna

    2017-06-12

    This study aimed to characterize the clinical trials with medicines enrolling Brazilian children and adolescents, registered in the databases of Clinical Trials and the Brazilian Clinical Trials Network (ReBEC) from 1994 to 2014. Only 462 clinical trials enrolled Brazilian children and adolescents. There was an increase in registrations beginning in 2003, with an important drop in 2011. Among these trials, 35.5% were hosted in Brazil. The international clinical trials were mostly conducted by North American companies. In both cases, multinational industry was the principal source of funding. The clinical trials were predominantly phase III with injectable and solid oral pharmaceutical forms of antiviral drugs. Domestic clinical trials showed wider variation in the pharmaceutical forms and higher percentage of liquid formulations, when compared to the international trials. In addition to heavy external dependence for conducting clinical trials, the study emphasized the challenge for pediatric care in Brazil, which presents epidemiological peculiarities in an environment prone to the use of unlicensed medicines for children.

  10. Update on interleukin-17: a role in the pathogenesis of inflammatory arthritis and implication for clinical practice

    Science.gov (United States)

    Miossec, Pierre

    2017-01-01

    Interleukin-17 (IL-17A) is a cytokine critical for the acute defence against extracellular bacterial and fungal infections. Excess production during chronic inflammation has been associated with many inflammatory and autoimmune disorders. The present review describes the key molecules of the IL-17 pathway, which are or could be targeted for treatment. Since targeting of IL-17A may affect defence mechanisms, the pathogenesis of such possible adverse events is analysed. Then the contributions of IL-17 to bone changes in various forms of arthritis are discussed. Finally, the results of current inhibitors of the IL-17 pathway in clinical trials are detailed. IL-17A inhibition has been first registered for the treatment of psoriasis, psoriatic arthritis and ankylosing spondylitis. Other therapeutic options are now tested in a long list of diseases. PMID:28243466

  11. Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives.

    Science.gov (United States)

    Sparks, Jeffrey A; Iversen, Maura D; Miller Kroouze, Rachel; Mahmoud, Taysir G; Triedman, Nellie A; Kalia, Sarah S; Atkinson, Michael L; Lu, Bing; Deane, Kevin D; Costenbader, Karen H; Green, Robert C; Karlson, Elizabeth W

    2014-09-01

    We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics, and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and the execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention.

  12. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor

    Science.gov (United States)

    Kavanaugh, Arthur; Mease, Philip J; Gomez-Reino, Juan J; Adebajo, Adewale O; Wollenhaupt, Jürgen; Gladman, Dafna D; Lespessailles, Eric; Hall, Stephen; Hochfeld, Marla; Hu, ChiaChi; Hough, Douglas; Stevens, Randall M; Schett, Georg

    2014-01-01

    Objectives Apremilast, an oral phosphodiesterase 4 inhibitor, regulates inflammatory mediators. Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1 (PALACE 1) compared apremilast with placebo in patients with active psoriatic arthritis despite prior traditional disease-modifying antirheumatic drug (DMARD) and/or biologic therapy. Methods In the 24-week, placebo-controlled phase of PALACE 1, patients (N=504) were randomised (1:1:1) to placebo, apremilast 20 mg twice a day (BID) or apremilast 30 mg BID. At week 16, patients without ≥20% reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose. Patients on background concurrent DMARDs continued stable doses (methotrexate, leflunomide and/or sulfasalazine). Primary outcome was the proportion of patients achieving 20% improvement in modified American College of Rheumatology response criteria (ACR20) at week 16. Results At week 16, significantly more apremilast 20 mg BID (31%) and 30 mg BID (40%) patients achieved ACR20 versus placebo (19%) (p<0.001). Significant improvements in key secondary measures (physical function, psoriasis) were evident with both apremilast doses versus placebo. Across outcome measures, the 30-mg group generally had higher and more consistent response rates, although statistical comparison was not conducted. The most common adverse events were gastrointestinal and generally occurred early, were self-limiting and infrequently led to discontinuation. No imbalance in major adverse cardiac events, serious or opportunistic infections, malignancies or laboratory abnormalities was observed. Conclusions Apremilast was effective in the treatment of psoriatic arthritis, improving signs and symptoms and physical function. Apremilast demonstrated an acceptable safety profile and was generally well tolerated. Clinical trial registration number NCT

  13. Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice

    DEFF Research Database (Denmark)

    Leffers, Henrik Christian; Ostergaard, Mikkel; Glintborg, Bente;

    2011-01-01

    To describe drug survival, disease activity and clinical response in patients with rheumatoid arthritis (RA) treated with abatacept or tocilizumab in routine care, based on prospectively registered observational data from the nationwide Danish DANBIO registry.......To describe drug survival, disease activity and clinical response in patients with rheumatoid arthritis (RA) treated with abatacept or tocilizumab in routine care, based on prospectively registered observational data from the nationwide Danish DANBIO registry....

  14. INFLUENCE OF PHYSIOTHERAPY ON CLINICAL AND IMMUNOLOGICAL PARAMETERS IN CHILDREN WITH JUVENILE RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    T.L. Nastausheva

    2008-12-01

    Full Text Available Clinical and immunological status has been evaluated in 85 children with juvenile rheumatoid arthritis (RA before and after physiotherapeutic procedures: electrophoresis with dimexid and magnetotherapy. The control group of 31 children did not follow physiotherapeutic procedures. The following results were fixed: clinical indices and immunological status of children with juvenile rheumatoid arthritis have been changed in a larger degree in case of magnetotherapy.

  15. Uncertainty and the ethics of clinical trials.

    Science.gov (United States)

    Hansson, Sven Ove

    2006-01-01

    A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible.

  16. [Situation analysis for drug clinical trial institutions].

    Science.gov (United States)

    Chen, Yin-Ying; Wu, Ping; Wang, Jie

    2014-08-01

    Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.

  17. The clinical and radiological evaluation of pyogenic arthritis

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Young Jun; Kim, Kyung Joo; Yoo, Jung Keun; Kim, Young Chul; Hur, Don [Chosun University College of Medicine, Gwangju (Korea, Republic of)

    1984-12-15

    Pyogenic arthritis remain a difficult problem, despite the availability of a wide range of powerful modern antibiotics. Early and correct diagnosis is imperative to assure the prompt initiation of an effective therapeutic regimen and the prevent of late sequela. Careful clinical, laboratory and roentgenological analysis are fundamental to early and precise diagnosis. Therefore, plain roentgenogram should not be overlooked. A radiological and clinical observation was made in 51 cases of pyogenic arthritis admitted to Chosun University Hospital during the period from January 1976 to December 1983 and following results were obtained. 1. Among the 51 cases, 36 cases (70.6%) were male and 15 cases (29.4%) were females. The most prevalent age was 5 to 9 (27.6%). 2. Symptom duration less than 5 days was in 21 cases (41.2%) and more than 31 days was in 6 cases (11.7%). 3. The most common symptom on admission was pain around the involved joint and others are limitation of motion, swelling, tenderness, fever, local heating and erythema. 4. The underlying causes were composed of unknown in 21 cases (41.2%), trauma in 18 cases (35.3%), infections focus in 8 cases (15.7%) and iatrogenic reason 4 cases (7.8%). 5. The most commonly affected joint was hip joint (45.1%). The other affected sites in order of frequency were knee, ankle, shoulder, S-I and elbow joint. In infants and children, hip and knee joint are commonly affected: in adults, knee joint is most is most commonly affected. 6. In laboratory findings, the number of W.B.C and E.S.R were increased in 56.9%. Symptom duration more than 31 days in 5 cases were increased E.S.R only. Causative microorganism was isolated in 31 cases: the most common microorganism was Staphylococcus aureus in 22 cases. Others are B-hemolytics Stretoocccus, Enterobacteriaceae species and Pseudomonas aeruginosa. 7. In 26 cases (50.9%) of the patients, roentgenographic findings was negative. The most common radiological findings was soft tissue

  18. The dynamics of response as measured by multiple composite outcome tools in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial.

    Science.gov (United States)

    Coates, Laura C; Mahmood, Farrouq; Emery, Paul; Conaghan, Philip G; Helliwell, Philip S

    2017-06-12

    We aimed to evaluate the dynamics of treatment response with different composite measures in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial. Participants with early disease-modifying antirheumatic drug-naïve psoriatic arthritis (PsA) were randomised 1:1 to either tight control (TC; 4 weekly review with therapy escalation if criteria not met) or standard care (SC; 12 weekly review). We calculated modified versions of the Psoriatic ArthritiS Disease Activity Score (PASDAS), Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite scorE (GRACE) and Composite Psoriatic Disease Activity Index (CPDAI) at baseline and 12 weekly to 48 weeks by blinded assessor. For missing data, we used the last observation carried forward. Comparison between groups was made by analysis of covariance and comparison of area under the curve (AUC). 206 people were randomised to TC (n=101) or SC (n=105). Significant differences between treatment groups were seen (pcomposite measures). AUC analysis demonstrated a significant difference between groups for the PASDAS but not GRACE and CPDAI. For participants with oligoarthritis, a significant difference between groups was seen for each measure, although the significance levels were greatly diminished (PASDAS, p=0.04; GRACE p=0.01; CPDAI p=0.04). For oligoarthritis using AUC analysis, none of the measures could distinguish between groups. Composite measures of disease activity were able to distinguish between TICOPA treatment arms, although differences were diminished for those with oligoarthritis. Further data are needed to inform the preferred composite measure for use as the primary outcome in PsA trials. ClinicalTrials.gov (NCT01106079) and ISCRCTN registry (ISCRCTN30147736). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    OpenAIRE

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-01-01

    Background To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. Methods The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, p...

  20. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    OpenAIRE

    Cihoric, Nikola; Tsikkinis, Alexandros; Gutierrez Miguelez, Cristina; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-01-01

    Background To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. Methods The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type,...

  1. Trial analytics--a tool for clinical trial management.

    Science.gov (United States)

    Bose, Anindya; Das, Suman

    2012-01-01

    Prolonged timelines and large expenses associated with clinical trials have prompted a new focus on improving the operational efficiency of clinical trials by use of Clinical Trial Management Systems (CTMS) in order to improve managerial control in trial conduct. However, current CTMS systems are not able to meet the expectations due to various shortcomings like inability of timely reporting and trend visualization within/beyond an organization. To overcome these shortcomings of CTMS, clinical researchers can apply a business intelligence (BI) framework to create Clinical Research Intelligence (CLRI) for optimization of data collection and analytics. This paper proposes the usage of an innovative and collaborative visualization tool (CTA) as CTMS "add-on" to help overwhelm these deficiencies of traditional CTMS, with suitable examples.

  2. Clinical and radiologic predictive factors of septic hip arthritis.

    Science.gov (United States)

    Kung, Justin W; Yablon, Corrie; Huang, Edward S; Hennessey, Hooman; Wu, Jim S

    2012-10-01

    The purpose of our study was to identify the clinical and radiologic factors associated with a positive culture during image-guided hip joint aspiration. We performed a retrospective analysis of 167 consecutive hip aspirations for septic arthritis at a large tertiary medical center. Chart review was performed on the following clinical factors: serum WBC count≥11×10(3)/μL, serum erythrocyte sedimentation rate (ESR)≥20 mm/h, C-reactive protein (CRP)≥100 mg/L, synovial fluid WBC count, synovial fluid polymorphonuclear (PMN) leukocytes≥90%, fever, immunosuppression, antibiotic use, diabetes, presence of a prosthesis, and IV drug use (IVDU). Radiologic studies were reviewed for the following imaging and technical factors: presence of a sinus tract, fluid turbidity, volume of fluid (mL) aspirated, and whether the fluid analyzed was primarily aspirated or reaspirated after lavage. Logistic regression was used to calculate odds ratio (OR) and 95% CI. Of the 167 aspirations, 29 (17.4%) had positive cultures; 6 of 29 (20.7%) positive cultures occurred in reaspirated lavage fluid. On multivariate analysis using logistic regression with stepwise backward elimination, the significant clinical and radiologic predictors were elevated WBC (OR, 4.4; 95% CI, 1.1-17.3), high percentage of synovial fluid PMN leukocytes (OR, 10.6; 95% CI, 2.9-39.8), IVDU (OR, 9.0; 95% CI, 1.3-64.7), and fluid turbidity (OR, 20.5; 95% CI, 6.9-61.4). Positive hip cultures are associated with elevated serum WBC, IVDU, high percentage of synovial fluid PMN leukocytes, and fluid aspirate turbidity. Reaspiration of lavage fluid with either nonbacteriostatic saline or contrast material can yield positive cultures.

  3. Data monitoring committees for pragmatic clinical trials.

    Science.gov (United States)

    Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan

    2015-10-01

    In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical

  4. Clinical Trials.Gov: A Topical Analyses.

    Science.gov (United States)

    Anand, Vibha; Cahan, Amos; Ghosh, Soumya

    2017-01-01

    ClinicalTrials.gov was established as a web-based registry for clinical trials of human participants in 2000. Mandatory registration started in 2008. Given more than a decade of registered trials, it's important to understand the "topic" areas and their evolution over time from this resource. This information may help in identifying current knowledge gaps. We use dynamic topic model (DTM) methods to discover topics and their evolution over last 17 years. Our model suggests that there are disease or organ specific trials such as 'Cardiovascular disorders', Heart & Brain conditions', or 'Breast & Prostate cancer' as well as trials registered for general health. General health trials are less likely to be FDA regulated, but both health and pain management, as well as surgical, heart, and brain trials have upward trend in recent years while advanced cancer trials have downward trended. Our model derives unique insights from metadata associated with each topic area.

  5. Interleukin-34 in rheumatoid arthritis: potential role in clinical therapy.

    Science.gov (United States)

    Zhang, Fangze; Ding, Rui; Li, Ping; Ma, Cuili; Song, Ding; Wang, Xuetong; Ma, Tianjiao; Bi, Liqi

    2015-01-01

    To investigate, whether interleukin (IL)-34 can be used as marker for treatment effectiveness in rheumatoid arthritis (RA). Serum samples were collected from 35 healthy participants and 83 patients with RA before as well as 4 weeks and 12 weeks after treatment initiation with the tumor necrosis factor α (TNF-α) inhibitor Etanercept. Related clinical data and hand radiograms of the patients were evaluated and serum IL-34, IL-6, IL-8, TNF-α, matrix metalloproteinase-3 (MMP-3) in addition to anti-cyclic citrullinated peptide (CCP) antibody concentrations were measured by ELISA. Serum concentrations of IL-34, IL-6, IL-8, TNF-α, MMP-3 and anti-CCP antibodies were markedly elevated in RA patients compared with controls (Panti-CCP antibodies in RA patients at baseline (P<0.01) and also with IL-8, MMP-3, IL-6, and DAS28 changes during therapy. Patients in stage III of hand X-ray RA scores had higher IL-34 serum concentrations than in stage II (P<0.05). IL-34 level decreased significantly (P<0.01) starting from 4 weeks after therapy initiation. IL-34 serum concentrations correlated with inflammatory cytokines before and during therapy and were significantly higher in stage III of hand X-ray score patients than in stage II participants. IL-34 might be used both as a biomarker for RA diagnosis and therapy efficiency.

  6. Why are clinical trials necessary in India?

    Directory of Open Access Journals (Sweden)

    Subramani Poongothai

    2014-01-01

    Full Text Available Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP. This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field.

  7. Ethics of clinical trials in Nigeria

    Directory of Open Access Journals (Sweden)

    Patrick I Okonta

    2014-01-01

    Full Text Available The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  8. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  9. The utility of clinical decision tools for diagnosing osteoporosis in postmenopausal women with rheumatoid arthritis.

    Science.gov (United States)

    Brand, Caroline; Lowe, Adrian; Hall, Stephen

    2008-01-29

    Patients with rheumatoid arthritis have a higher risk of low bone mineral density than normal age matched populations. There is limited evidence to support cost effectiveness of population screening in rheumatoid arthritis and case finding strategies have been proposed as a means to increase cost effectiveness of diagnostic screening for osteoporosis. This study aimed to assess the performance attributes of generic and rheumatoid arthritis specific clinical decision tools for diagnosing osteoporosis in a postmenopausal population with rheumatoid arthritis who attend ambulatory specialist rheumatology clinics. A cross-sectional study of 127 ambulatory post-menopausal women with rheumatoid arthritis was performed. Patients currently receiving or who had previously received bone active therapy were excluded. Eligible women underwent clinical assessment and dual-energy-xray absorptiometry (DXA) bone mineral density assessment. Clinical decision tools, including those specific for rheumatoid arthritis, were compared to seven generic post-menopausal tools to predict osteoporosis (defined as T score perform better than generic tools, however, the National Osteoporosis Foundation score could potentially reduce the number of unnecessary DXA tests by approximately 45% in this population. There was limited utility of clinical decision tools for predicting osteoporosis in this patient population. Fracture prediction tools that include risk factors independent of BMD are needed.

  10. Functional limitations in the phase of clinically suspect arthralgia are as serious as in early clinical arthritis; a longitudinal study.

    Science.gov (United States)

    Ten Brinck, Robin M; van Steenbergen, Hanna W; Mangnus, Lukas; Burgers, Leonie E; Reijnierse, Monique; Huizinga, Tom Wj; van der Helm-van Mil, Annette Hm

    2017-01-01

    A phase of arthralgia may precede the emergence of rheumatoid arthritis (RA). Although several studies have focused on biomarkers, the relevance of this phase for patients is less studied. It is unknown if patients already have functional limitations and if this is correlated to the extent of subclinical inflammation. Therefore, we assessed functional disability in patients with clinically suspect arthralgia (CSA), its association with MRI-detected subclinical inflammation and its course during progression to clinical arthritis. From April 2012 to March 2015, 241 patients had arthralgia for <1 year and were, based on clinical presentation, considered at risk for RA by their rheumatologists. At baseline, Health Assessment Questionnaire (HAQ) scores were determined and unilateral 1.5 T MRI of metacarpophalangeal, wrist and metatarsophalangeal joints were made. Presence of MRI-detected subclinical inflammation was assessed by summing synovitis, tenosynovitis and bone marrow oedema scores (range 0-189). Patients were followed on arthritis development and HAQ scores were repeated when clinical arthritis had developed. The median HAQ score at presentation with CSA was 0.50. Higher MRI-inflammation scores were associated with higher HAQ scores (β=0.017, 95% CI=0.004 to 0.030). During median 103 weeks follow-up, 44 patients progressed to clinical arthritis. HAQ scores ≥1.0 were associated with arthritis development (HR=2.50, 95% CI=1.03 to 6.10). Within converters, median HAQ scores did not increase from presentation with CSA to arthritis development (0.88 and 0.75, p=0.36). HAQ scores ≥1.0 at presentation were associated with the development of clinical arthritis. Functional limitations in the prearthritis phase of CSA were as serious as in the early clinical phase, demonstrating the relevance of CSA from patients' perspectives.

  11. The unintended consequences of clinical trials regulations.

    Directory of Open Access Journals (Sweden)

    Alex D McMahon

    2009-11-01

    Full Text Available Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH guidance on good clinical practice (GCP, arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.

  12. The unintended consequences of clinical trials regulations

    OpenAIRE

    Alex D McMahon; Conway, David I; MacDonald, Tom M; McInnes, Gordon T

    2009-01-01

    Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.

  13. Experimental arthritis induced by a clinical Mycoplasma fermentans isolate

    Directory of Open Access Journals (Sweden)

    Giono Silvia

    2002-06-01

    Full Text Available Abstract Background Mycoplasma fermentans has been associated with rheumatoid arthritis. Recently, it was detected in the joints and blood of patients with rheumatoid arthritis, but it is not clear yet how the bacteria enter the body and reach the joints. The purpose of this study was to determine the ability of M. fermentans to induce experimental arthritis in rabbits following inoculation of the bacteria in the trachea and knee joints. Methods P-140 and PG-18 strains were each injected in the knee joints of 14 rabbits in order to evaluate and compare their arthritogenicity. P-140 was also injected in the trachea of 14 rabbits in order to test the ability of the bacteria to reach the joints and induce arthritis. Results M. fermentans produced an acute arthritis in rabbits. Joint swelling appeared first in rabbits injected with P-140, which caused a more severe arthritis than PG-18. Both strains were able to migrate to the uninoculated knee joints and they were detected viable in the joints all along the duration of the experiment. Changes in the synovial tissue were more severe by the end of the experiment and characterized by the infiltration of neutrophils and substitution of adipose tissue by connective tissue. Rabbits intracheally injected with P-140 showed induced arthritis and the bacteria could be isolated from lungs, blood, heart, kidney, spleen, brain and joints. Conclusion M. fermentans induced arthritis regardless of the inoculation route. These findings may help explain why mycoplasmas are commonly isolated from the joints of rheumatic patients.

  14. PREVALENCE OF CAPRINE ARTHRITIS ENCEPHALITIS VIRUS IN ASSOCIATION WITH CLINICAL ARTHRITIS IN SIX PRODUCTION FARMS OF FRENCH ALPINE GOATS IN NORTH-WESTERN CROATIA

    Directory of Open Access Journals (Sweden)

    Bruna Tariba

    2015-09-01

    Full Text Available Prevalence of Caprine Arthritis Encephalitis Virus (CAEV and occurrence of clinical arthritis were investigated on 543 goats of French Alpine breed on six intensive production farms in North-Western Croatia. The aim of the study was to determine seropositivity to CAEV and to examine the occurrence of clinical arthritis in relation to CAEV seropositive goats. All goats were examined clinically and presence of arthritis was noted. The blood samples were tested for antibodies against CAEV using the immunoenzyme test. All collected data were cross-classified in two-way contingency tables. Of the total number of goats, CAEV was serologically confirmed in 50.8% and 31.6% of all goats were diagnosed with clinical arthritis. CAEV seropositive goats were 21.9% and they also expressed clinical signs of arthritis. Statistical tests confirmed positive association between clinical arthritis diagnosis and seropositivity to CAEV with Phi coefficient of 0.25 (P<0.01. Results suggest that serious eradication programs should be introduced in north western Croatian goat herds, but also that further investigations in all Croatian herds should be conducted and measures should be applied on all herds.

  15. Minorities and Clinical Trials: Patients, Physicians, Clinical Trial Characteristics and their Environment

    Science.gov (United States)

    2012-07-01

    in peer-reviewed journals REPORTABLE OUTCOMES  Kaplan, C., Napoles, A., Gregorich, S., Nguyen, T., & Roach, M. (2011, March ). Assessment of the...Posting the trials on your hospital/organization’s website i. Other activities, please specify: Email Version: March 2010 4 of 4 21...1 0 77 99 i. Other Cancer 1 0 77 99 i1. CANCER SPECIFY: ____________________________ j. Depression 1 0 77 99 k. Arthritis ( Osteoarthritis

  16. Socio-demographic and clinical aspects of rheumatoid arthritis.

    Science.gov (United States)

    Owino, B O; Oyoo, G O; Otieno, C F

    2009-05-01

    To determine the socio-demographic profiles and some clinical aspects of patients with rheumatoid arthritis (RA). Prospective, cross-sectional study. Ambulatory out- patient clinics of Kenyatta National Hospital (KNH), a public national and referral hospital. Out of 180 patients interviewed and examined, 60 met American College of Rheumatology (ACR) diagnostic criteria of RA. Of the 60 patients recruited 52 (87%) were females with male: female ratio of 1: 6.5. The mean age of patients was 41.38(+/- 16.8) years. There were two peaks of age of occurrence, 20-29 and 40-49 years. In 75% of the study patients, one or more of metacarpophalangeal joints of the hand were involved in the disease. Other frequently involved sites were--wrists, elbows, knees, ankles and glenohumeral joints of shoulders in a symmetrical manner. Serum rheumatoid factor was positive in 78.9% while rheumatoid nodules were present in 13.3% of the study patients. A large majority of patients (88%) had active disease with 18% having mild disease, 38% moderate activity and 32% having severe disease. Only 12% of patients had disease in remission. Forty six point seven per cent (46.7%) of the study patients were on at least one Disease Modifying anti Rheumatic Drugs (DMARD) from a selection of methotrexate, sulphasalazine, hydroxychloroquine and leflunamide. The most frequent drug combination was methotrexate plus prednisolone at 30% of the study population; while 66.7% were on oral prednisolone with 25% of the study patients taking only Non-Steroidal anti Inflammatory Drugs (NSAIDS). A large majority of ambulatory patients with RA had active disease. Most of them were sub-optimally treated, especially the use of DMARDS. About two thirds were on oral steroids. Sub-optimal therapy in relatively young patients, peak 20-29 and 40-49 years is likely to impact negatively on their disease control and quality of life.

  17. Pathogenesis and clinical manifestations of juvenile rheumatoid arthritis.

    Science.gov (United States)

    Hahn, Youn-Soo; Kim, Joong-Gon

    2010-11-01

    Juvenile rheumatoid arthritis (JRA) is the most common rheumatic childhood disease; its onset is before 16 years of age and it persists for at least 6 weeks. JRA encompasses a heterogeneous group of diseases that is classified according to 3 major presentations: oligoarthritis, polyarthritis, and systemic onset diseases. These presentations may originate from the same or different causes that involve interaction with specific immunogenetic predispositions, and result in heterogeneous clinical manifestations. An arthritic joint exhibits cardinal signs of joint inflammation, such as swelling, pain, heat, and loss of function; any joint can be arthritic, but large joints are more frequently affected. Extra-articular manifestations include high fever, skin rash, serositis, and uveitis. The first 2 types of JRA are regarded as T helper 1 (Th1) cell-mediated inflammatory disorders, mainly based on the abundance of activated Th1 cells in the inflamed synovium and the pathogenetic role of proinflammatory cytokines that are mainly produced by Th1 cell-stimulated monocytes. In contrast, the pathogenesis of systemic onset disease differs from that of other types of JRA in several respects, including the lack of association with human leukocyte antigen type and the absence of autoantibodies or autoreactive T cells. Although the precise mechanism that leads to JRA remains unclear, proinflammatory cytokines are thought to be responsible for at least part of the clinical symptoms in all JRA types. The effectiveness of biologic therapy in blocking the action of these cytokines in JRA patients provides strong evidence that they play a fundamental role in JRA inflammation.

  18. Concepts of pathogenesis in psoriatic arthritis: genotype determines clinical phenotype.

    LENUS (Irish Health Repository)

    FitzGerald, Oliver

    2015-05-07

    This review focuses on the genetic features of psoriatic arthritis (PsA) and their relationship to phenotypic heterogeneity in the disease, and addresses three questions: what do the recent studies on human leukocyte antigen (HLA) tell us about the genetic relationship between cutaneous psoriasis (PsO) and PsA - that is, is PsO a unitary phenotype; is PsA a genetically heterogeneous or homogeneous entity; and do the genetic factors implicated in determining susceptibility to PsA predict clinical phenotype? We first discuss the results from comparing the HLA typing of two PsO cohorts: one cohort providing the dermatologic perspective, consisting of patients with PsO without evidence of arthritic disease; and the second cohort providing the rheumatologic perspective, consisting of patients with PsA. We show that these two cohorts differ considerably in their predominant HLA alleles, indicating the heterogeneity of the overall PsO phenotype. Moreover, the genotype of patients in the PsA cohort was shown to be heterogeneous with significant elevations in the frequency of haplotypes containing HLA-B*08, HLA-C*06:02, HLA-B*27, HLA-B*38 and HLA-B*39. Because different genetic susceptibility genes imply different disease mechanisms, and possibly different clinical courses and therapeutic responses, we then review the evidence for a phenotypic difference among patients with PsA who have inherited different HLA alleles. We provide evidence that different alleles and, more importantly, different haplotypes implicated in determining PsA susceptibility are associated with different phenotypic characteristics that appear to be subphenotypes. The implication of these findings for the overall pathophysiologic mechanisms involved in PsA is discussed with specific reference to their bearing on the discussion of whether PsA is conceptualised as an autoimmune process or one that is based on entheseal responses.

  19. Function: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shakuri Seyed Kazem

    2015-03-01

    Full Text Available Introduction: Prevention of pulmonary complications after coronary artery bypass graft is attended as a very important issue. The aim of this study was to evaluate the role of pulmonary rehabilitation before surgery for reducing the risk of pulmonary complications after surgery. Methods: In a randomized clinical trial, 60 patients undergoing heart surgery were randomly divided into two groups A and B. Chest physiotherapy was performed before and after surgery on group A patients however it was done on group B’s, only after surgery. Effects of preoperative pulmonary rehabilitation were compared between two groups, using spirometry and arterial blood gas (ABG. Results: Thirty nine males (65% and 21 females (35% with mean age of 8.10 ± 9.56 were analyzed.The mean differences were statistically significant for predicted forced vital capacity (FVC (CI95%:1.3 to 8.7 and Predicted Peak Flow indices (PEF (CI 95%: 1.9 to 9.4 of spirometry indicator,PCO2 index (of ABG parameter (CI 95%: 1.4 to 8.9 and mean oxygen saturation (mean Spo2 (CI 95%: 0.6 to 1.7 of ABG index in two groups. Conclusion: The performance of pulmonary rehabilitation program before surgery is recommended, as it may result in the reduction of complications of heart surgery.

  20. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  1. CLINICAL CASE OF TOCILIZUMAB THERAPY IN A PATIENT WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

    Directory of Open Access Journals (Sweden)

    E. I. Alexeeva

    2013-01-01

    Full Text Available The article presents a case of successful application of a monoclonal antibodies drug to interleukin 6 receptors (tocilizumab at severe systemic juvenile idiopathic arthritis with the development of secondary hemophagocytic syndrome. Tocilizumab treatment secured a decrease in clinical and laboratory parameters of the disease activity, life quality improvement, systemic juvenile idiopathic arthritis and hemophagocytic syndrome remission and allowed avoiding the per os prescription of glucocorticoids.

  2. Clinical Aspects of Pregnancy-induced Amelioration of Rheumatoid Arthritis: PARA-study

    OpenAIRE

    Man, Yael

    2009-01-01

    textabstractIn this PhD thesis, embedded in the PARA (Pregnancy-induced Amelioration of Rheumatoid Arthritis) study, several clinical aspects of the spontaneously occurring pregnancy-induced improvement of rheumatoid arthritis (RA) are addressed. An overview is given of inflammatory rheumatic diseases and the current knowledge about their disease courses and treatment options during pregnancy and postpartum. This thesis focuses firstly on the description of tools to objectively measure the di...

  3. Use of a validated screening tool for psoriatic arthritis in dermatology clinics

    OpenAIRE

    Ganatra, Bella; Manoharan, Dishan; Akhras, Victoria

    2015-01-01

    Dermatology clinics represent a key opportunity to screen patients with psoriasis for psoriatic arthritis (PA) which often remains unrecognised. A significant proportion of adults with psoriasis develop arthropathy [5] with around two-thirds having progressive arthritis.[6] NICE has recognised this by the annual use of a validated screening tool such as psoriasis epidemiological screening tool (PEST) on all psoriasis patients without PA. We introduced the PEST into our dermatology department ...

  4. Inflammation and autoantibody markers identify rheumatoid arthritis patients with enhanced clinical benefit following rituximab treatment.

    Science.gov (United States)

    Lal, Preeti; Su, Zheng; Holweg, Cecile T J; Silverman, Gregg J; Schwartzman, Sergio; Kelman, Ariella; Read, Simon; Spaniolo, Greg; Monroe, John G; Behrens, Timothy W; Townsend, Michael J

    2011-12-01

    Rituximab significantly improves the signs and symptoms of rheumatoid arthritis (RA) and slows the progression of joint damage. The aim of this study was to identify clinical characteristics and biomarkers that identify patients with RA in whom the clinical benefit of rituximab may be enhanced. The study group comprised 1,008 RA patients from 2 independent randomized placebo-controlled phase III clinical trials (REFLEX [Randomized Evaluation of Long-Term Efficacy of Rituximab in Rheumatoid Arthritis] and SERENE [Study Evaluating Rituximab's Efficacy in Methotrexate Inadequate Responders]). A novel threshold selection method was used to identify baseline candidate biomarkers present in at least 20% of patients that enriched for placebo-corrected American College of Rheumatology 50% improvement (ACR50 response; a high clinical efficacy bar) at week 24 after the first course of rituximab. The presence of IgM rheumatoid factor (IgM-RF), IgG-RF, IgA-RF, and IgG anti-cyclic citrullinated peptide (anti-CCP) antibodies together with an elevated C-reactive protein (CRP) level were associated with enhanced placebo-corrected ACR50 response rates in the REFLEX patients with RA who had an inadequate response to anti-tumor necrosis factor therapies. These findings were independently replicated using samples from patients in SERENE who had an inadequate response to disease-modifying antirheumatic drug treatment. The combination of an elevated baseline CRP level together with an elevated level of any RF isotype and/or IgG anti-CCP antibodies was further associated with an enhanced benefit to rituximab. The presence of any RF isotype and/or IgG anti-CCP autoantibodies together with an elevated CRP level identifies a subgroup of patients with RA in whom the benefit of rituximab treatment may be enhanced. Although the clinical benefit of rituximab was greater in the biomarker-positive population compared with the biomarker-negative population, the clinical benefit of rituximab

  5. Varied acceptance of clinical trial results.

    Science.gov (United States)

    Klimt, C R

    1989-12-01

    The subject of varied acceptance of clinical trial results is discussed in the context of review of trials with which I have been involved and my subjective evaluation of their impact on the practice of clinical medicine. My experience goes back to 1949 and a World Health Organization trial of hyperimmune gamma globulin against rabies. This was followed by a large trial of secondary prevention of poliomyelitis. I participated in the planning and initiation of the first chronic disease trial, the University Group Diabetes Program (UGDP). The latter lasted for 15 years and its ramifications continue to this day. My next trial was the Coronary Drug Project (CDP), a complex trial with more than 8,000 patients. The trials of aspirin and aspirin combined with persantine (the CDPA, AMIS, PARIS I, and PARIS II) followed. My last three trials were a trial of photocoagulation in diabetic retinopathy (DRS), a six-country trial of the antiarrhythmic drug mexiletine (IMPACT), and a study involving two diagnostic procedures for pulmonary embolism (PIOPED). When one considers, in retrospect, the plethora of trials one is struck by the uniform absence of a priori considerations of the impact on medical practice, or likely lack thereof, of possible outcomes.

  6. Acute Stroke | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available n(s) being investigated Acute Stroke MedDRA Classification E.1.3Condition being s... General Information on the Trial E.1 Medical condition or disease under investigation E.1.1Medical conditio

  7. Predictors of poor response to methotrexate in polyarticular-course juvenile idiopathic arthritis: analysis of the PRINTO methotrexate trial

    NARCIS (Netherlands)

    Vilca, I.; Munitis, P.G.; Pistorio, A.; Ravelli, A.; Buoncompagni, A.; Bica, B.; Campos, L.; Häfner, R.; Hofer, M.; Ozen, S.; Huemer, C.; Bae, S.C.; Sztajnbok, F.; Arguedas, O.; Foeldvari, I.; Huppertz, H.I.; Gamir, M.L.; Magnusson, B.; Dressler, F.; Uziel, Y.; van Rossum, M.A.J.; Hollingworth, P.; Cawkwell, G.; Martini, A.; Ruperto, N.

    2010-01-01

    Objectives To determine whether baseline demographic, clinical, articular and laboratory variables predict methotrexate (MTX) poor response in polyarticular-course juvenile idiopathic arthritis. Methods Patients newly treated for 6 months with MTX enrolled in the Paediatric Rheumatology Internationa

  8. Clinical uses of melatonin: evaluation of human trials.

    Science.gov (United States)

    Sánchez-Barceló, E J; Mediavilla, M D; Tan, D X; Reiter, R J

    2010-01-01

    During the last 20 years, numerous clinical trials have examined the therapeutic usefulness of melatonin in different fields of medicine. The objective of this article is to review, in depth, the science regarding clinical trials performed to date. The efficacy of melatonin has been assessed as a treatment of ocular diseases, blood diseases, gastrointestinal tract diseases, cardiovascular diseases, diabetes, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, infectious diseases, neurological diseases, sleep disturbances, aging and depression. Melatonin has been also used as a complementary treatment in anaesthesia, hemodialysis, in vitro fertilization and neonatal care. The conclusion of the current review is that the use of melatonin as an adjuvant therapy seems to be well funded for macular degeneration, glaucoma, protection of the gastric mucosa, irritable bowel syndrome, arterial hypertension, diabetes, side effects of chemotherapy and radiation in cancer patients or hemodialysis in patients with renal insufficiency and, especially, for sleep disorders of circadian etiology (jet lag, delayed sleep phase syndrome, sleep deterioration associated with aging, etc.) as well as in those related with neurological degenerative diseases (Alzheimer, etc.,) or Smith-Magenis syndrome. The utility of melatonin in anesthetic procedures has been also confirmed. More clinical studies are required to clarify whether, as the preliminary data suggest, melatonin is useful for treatment of fibromyalgia, chronic fatigue syndrome, infectious diseases, neoplasias or neonatal care. Preliminary data regarding the utility of melatonin in the treatment of ulcerative colitis, Crohn's disease, rheumatoid arthritis are either ambiguous or negative. Although in a few cases melatonin seems to aggravate some conditions, the vast majority of studies document the very low toxicity of melatonin over a wide range of doses.

  9. Paperless clinical trials: Myth or reality?

    Science.gov (United States)

    Gupta, Sandeep K.

    2015-01-01

    There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process. PMID:26288464

  10. Paperless clinical trials: Myth or reality?

    Directory of Open Access Journals (Sweden)

    Sandeep K Gupta

    2015-01-01

    Full Text Available There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.

  11. Paperless clinical trials: Myth or reality?

    Science.gov (United States)

    Gupta, Sandeep K

    2015-01-01

    There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.

  12. Clinical periodontal and microbiologic parameters in patients with rheumatoid arthritis.

    Science.gov (United States)

    Ziebolz, Dirk; Pabel, Sven O; Lange, Katharina; Krohn-Grimberghe, Berndt; Hornecker, Else; Mausberg, Rainer F

    2011-10-01

    A limited number of studies suggest a prevalence of periodontal pathogens in patients with rheumatoid arthritis (RA); however, results are inconsistent. The aim of this study is to investigate clinical periodontal and microbiologic parameters in patients with RA. Sixty-six patients with RA, aged 49.5 ± 8.4 years, participated in the study. The periodontal classification was assessed with the periodontal screening index (PSR/PSI) allocated to the following parameters: 1) healthy; 2) gingivitis (PSR/PSI score 0 to 2, maximum one sextant score; 3) moderate periodontitis (>1 sextant PSR/PSI score 3, maximum one sextant score; or, 4) severe periodontitis (>1 sextant PSR/PSI score 4). Pool samples were taken for microbiologic (polymerase chain reaction) analysis for the presence of 11 periodontal pathogens. Statistical analysis was by non-parametric analysis of covariance. No patients were periodontally healthy: 24 patients were classified as having gingivitis; 18 patients had moderate periodontitis; 23 patients had severe periodontitis; and one patient was toothless. For most patients, Fusobacterium nucleatum (98%), Eikenella corrodens (91%), and Parvimonas micra (previously Peptostreptococcus micros; 88%) were above the detection threshold. Strong periodontal pathogens were less frequently detected: Aggregatibacter actinomycetemcomitans (previously Actinobacillus actinomycetemcomitans, 16%); Porphyromonas gingivalis (58%); and Tannerella forsythia (previously T. forsythensis, 78%). Statistical analysis showed no significant influence of rheumatic factor (P = 0.33) on periodontal classification and on microbiologic parameters (P >0.05). Only smoking showed a significant influence (P = 0.0004) on the periodontal classification and in the case of E. corrodens (P = 0.02). Most patients with RA in this study showed moderate-to-severe periodontitis and the presence of periodontal pathogens. No association was found between rheumatic factor on periodontal classification and

  13. MRI comes of age in RA clinical trials

    DEFF Research Database (Denmark)

    Peterfy, Charles; Østergaard, Mikkel; Conaghan, Philip G

    2013-01-01

    The success of modern rheumatoid arthritis (RA) therapies and treatment strategies has led to extended placebo phases being unethical in RA randomised controlled trials (RCTs). Modern trials therefore increasingly involve active comparator designs, and this together with some technical issues has...

  14. Terminating a long-term clinical trial.

    Science.gov (United States)

    Klimt, C R

    1981-05-01

    Long-term clinical trials often include more than one active treatment group. These may be discontinued independently if found to be ineffective or possibly harmful. Certain subgroups of patients may be discovered, in the course of a clinical trial, who do not respond satisfactorily and are, therefore, excluded during the course of a trial. Yet another kind of termination comes when we have a therapeutic breakthrough or when hope has to be abandoned for demonstrating beneficial effects for one, several, or all treatments included in a trial. Examples from the authors' experience are presented, as are successful and unsuccessful techniques in managing terminations of various types.

  15. Construction of ethics in clinical research: clinical trials registration

    OpenAIRE

    C. A. Caramori

    2007-01-01

    Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong c...

  16. The Clinical Trials Transformation Initiative (CTTI

    Directory of Open Access Journals (Sweden)

    Alberto Grignolo

    2011-01-01

    Full Text Available The Clinical Trials Transformation Initiative (CTTI is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. The initiative was generated from the realization that the clinical trials system in the United States has been suffering as a result of increasingly longer study start-up times, slowing enrollment of patients into trials, increasing clinical trial costs, and declining investigator interest in participating in clinical trials. Although CTTI was created to address a crisis for US clinical research, it seeks to identify practice improvements that can be applied internationally, and is therefore engaging international collaborators with international efforts that have similar objectives. CTTI's approach is to involve all sectors in the selection, conduct, and interpretation of its projects; to keep the dialogue open across sectors; to provide evidence that can influence regulatory guidance, and to attempt to create a "level playing field" when recommending change. The hope is that a broad and diverse data-driven discussion of the important issues in clinical trials will lead to meaningful change for the benefit of all concerned, and importantly for patients.

  17. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong

    2013-04-01

    Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  18. The first national clinical audit for rheumatoid arthritis.

    Science.gov (United States)

    Firth, J; Snowden, N; Ledingham, J; Rivett, A; Galloway, J; Dennison, E M; MacPhie, E; Ide, Z; Rowe, I; Kandala, N; Jameson, K

    The first national audit for rheumatoid and early inflammatory arthritis has benchmarked care for the first 3 months of follow-up activity from first presentation to a rheumatology service. Access to care, management of early rheumatoid arthritis and support for self care were measured against National Institute for Health and Care Excellence quality standards; impact of early arthritis and experience of care were measured using patient-reported outcome and experience measures. The results demonstrate delays in referral and accessing specialist care and the need for service improvement in treating to target, suppression of high levels of disease activity and support for self-care. Improvements in patient-reported outcomes within 3 months and high levels of overall satisfaction were reported but these results were affected by low response rates. This article presents a summary of the national data from the audit and discusses the implications for nursing practice.

  19. Overlap between systemic sclerosis and rheumatoid arthritis: a distinct clinical entity?

    Directory of Open Access Journals (Sweden)

    Alex Magno Coelho Horimoto

    Full Text Available ABSTRACT Introduction: Systemic sclerosis (SSc is an autoimmune disease of the connective tissue characterized by the triad of vascular injury, autoimmunity (cellular and humoral and tissue fibrosis. It is estimated that musculoskeletal pain is a common complaint of patients with SSc, ranging from 40 to 80%, and mainly in patients with early diffuse disease. Arthritis, clinically observed, may be a feature seen in the presentation of SSc, often leading to early diagnostic errors with rheumatoid arthritis (RA. In the course of the disease, arthritis is observed in 24–97% of patients with SSc. Objectives: To correlate the occurrence or nonoccurrence of arthritis in patients with SSc of the Midwest region of Brazil with possible distinct clinical and laboratory manifestations observed in three groups of patients. To report the frequency of true association between systemic sclerosis and rheumatoid arthritis in patients with clinically and radiologically observed synovitis. Methods: Sixty-one SSc patients were subsequently assessed every 3 months within 1 year, in order to clinically observe the occurrence of synovitis and its patterns of progression. Patients were divided into 3 groups: 41 patients with SSc without arthritis, 16 SSc patients with arthritis and 4 patients with overlap of SSc and RA. All patients underwent a radiological examination of the hands at the end of the study. Results: Among all patients evaluated, we found a female predominance (98.7%, mean age of 50.94 years, white color (49.2%, limited form of the disease (47.6%, time of diagnosis between 5 and 10 years (47.6% and duration of the disease of 8.30 years. Among all patients, 14 (22.9% had positive rheumatoid factor (RF, while among those with positive RF, only 10 patients had arthritis during one-year follow-up. The antibody anticitrulline (anti-CCP test was performed in 24 patients, being positive in 4 of them (16.7%, with positivity being observed only in patients with

  20. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    BACKGROUND: Registration of interventional studies is necessary according to the Declaration of Helsinki but implementation has been a challenge for many journals. Acta Anaesthesiologica Scandinavica (Acta) requires registration for studies conducted after January 1(st) 2010. We aimed to assess...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...

  1. Clinical Trials and the Role of the Oncology Clinical Trials Nurse.

    Science.gov (United States)

    Ness, Elizabeth A; Royce, Cheryl

    2017-03-01

    Clinical trials are paramount to improving human health. New trial designs and informed consent issues are emerging as a result of genomic profiling and the development of molecularly targeted agents. Many groups and individuals are responsible for ensuring the protection of research participants and the quality of the data produced. The specialty role of the clinical trials nurse (CTN) is critical to clinical trials. Oncology CTNs have competencies that can help guide their practice; however, not all oncology clinical trials are supervised by a nurse. Using the process of engagement, one organization has restructured oncology CTNs under a nurse-supervised model.

  2. Acute Schizophrenia | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available nter, Randomized, Double-blind, Placebo-controlled Trial of Three Fixed Doses of OPC-34712 in the Treatment of Adults With Acute...2 in the Treatment of Adults With Acute Schizophrenia A.4.1Sponsor's protocol code number331-10-231 A.5.2US ... Information on the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...ition or disease under investigation E.1.2Version 14.1 E.1.2Level LLT E.1.2Classification code 10001064 E.1.2Term Acute

  3. Acute Schizophrenia | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available 2, and 1 mg/day) in the Treatment of Adults With Acute Schizophrenia A.3.1Title ...of the trial for lay people, in easily understood, i.e. non-technical, language Efficacy Study of OPC-34712 in Adults With Acute...e Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...nder investigation E.1.2Version 14.0 E.1.2Level LLT E.1.2Classification code 10001064 E.1.2Term Acute schizo

  4. Anti-TNFα-therapy as an evidence-based treatment option for different clinical manifestations of psoriatic arthritis.

    Science.gov (United States)

    Köhm, Michaela; Burkhardt, Harald; Behrens, Frank

    2015-01-01

    The development programmes of different TNF-blocking agents in psoriatic arthritis (PsA) not only provided substantial evidence for the therapeutic benefits of the specific treatment options, but also enabled new insights into the differential treatment effects on distinct disease manifestations. For the first time, specific robust evidence for distinctive effects on different manifestations of PsA, as a distinct entity separate from rheumatoid arthritis (RA), has been generated in a standardized way. The clearest evidence was shown for an effect on peripheral arthritis (polyarticular) with ACR20 response rates from 45 up to 58% (vs. 9-24% for placebo), and an inhibition of radiographic progression demonstrated for the first time for a treatment principle in PsA. However, as PsA does not remain confined to the peripheral joints, it was necessary to address diverse patterns of PsA-subtypes in the outcome measurements of the anti-TNF trials. Accordingly, the results of the clinical studies on anti-TNF treatment also have demonstrated efficacy on enthesitis, dactylitis and skin psoriasis, either in sub analysis of results from phase III RCTs, or in additional prospective studies.

  5. Justifying clinical trials for porcine islet xenotransplantation.

    Science.gov (United States)

    Ellis, Cara E; Korbutt, Gregory S

    2015-01-01

    The development of the Edmonton Protocol encouraged a great deal of optimism that a cell-based cure for type I diabetes could be achieved. However, donor organ shortages prevent islet transplantation from being a widespread solution as the supply cannot possibly equal the demand. Porcine islet xenotransplantation has the potential to address these shortages, and recent preclinical and clinical trials show promising scientific support. Consequently, it is important to consider whether the current science meets the ethical requirements for moving toward clinical trials. Despite the potential risks and the scientific unknowns that remain to be investigated, there is optimism regarding the xenotransplantation of some types of tissue, and enough evidence has been gathered to ethically justify clinical trials for the most safe and advanced area of research, porcine islet transplantation. Researchers must make a concerted effort to maintain a positive image for xenotransplantation, as a few well-publicized failed trials could irrevocably damage public perception of xenotransplantation. Because all of society carries the burden of risk, it is important that the public be involved in the decision to proceed. As new information from preclinical and clinical trials develops, policy decisions should be frequently updated. If at any point evidence shows that islet xenotransplantation is unsafe, then clinical trials will no longer be justified and they should be halted. However, as of now, the expected benefit of an unlimited supply of islets, combined with adequate informed consent, justifies clinical trials for islet xenotransplantation.

  6. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Science.gov (United States)

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

    2015-05-01

    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well.

  7. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  8. Acute pancreatitis | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available lot Trial of Indomethacin in Acute Pancreatitis Ensayo piloto controlado y aleatorizado con indometacina en ....1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...n criteria Patients ages 18 or above admitted to hospital with a diagnosis of Acute pancreatitis (AP) based

  9. Acute Rhinosinusitis | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available edical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute Rhinosinu....2.3Trial contains a sub-study No E.3Principal inclusion criteria 1. Adult male and female outpatients aged ≥ 18 - 75 years 2. Acute

  10. Clinical Trials: Information and Options for People with Mood Disorders

    Science.gov (United States)

    ... Releases & Announcements Public Service Announcements Partnering with DBSA Clinical Trials: Information and Options for People with Mood Disorders What are clinical trials? Clinical trials are research studies involving people, which ...

  11. Clinical Trials | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn JavaScript on. Feature: Clinical Trials Clinical Trials, A Healthier Future for All Past Issues / Fall ... in was reviewed by an IRB. Find a Clinical Trial Near You Health research takes place at hospitals, ...

  12. Clinical and Immunomodulatory Effect of Fun-boi, an Herbal Medicine, in Rheumatoid Arthritis.

    Science.gov (United States)

    Niizawa, A; Kogure, T; Fujinaga, H; Takahashi, K; Shimada, Y; Terasawa, K

    2000-10-01

    Crude preparations of Fun-boi (Fen-fan-ji in Chinese), a traditional anti-rheumatic herb, have been used safely over millennia. To begin to study the efficacy of Fun-boi on the disease activity and the peripheral lymphocyte subsets, we performed a 12-week, open-label trial of Fun-boi extract (a decoction of Fun-boi 10 g/day) in 29 patients with rheumatoid arthritis (RA). Most clinical and immunological variables: swollen joint count, physician's and patient's assessment, pain score and IgM rheumatoid factor, showed statistically significant improvement. Seven (24%) of the enrolled patients met the American College of Rheumatology (ACR) criteria for a 20 percent improvement in measures of disease activity (ACR20) and 3 (10%) met those for ACR50. The CD3+CD8+ lymphocytes were increased significantly. Accordingly, the CD4/CD8 ratio was decreased; however, these changes did not show any clear correlation with clinical response. Two patients (7%) experienced some minor transient adverse events. In conclusion, Fun-boi is safe and showed beneficial effect in some patients for the treatment of the relatively mild RA seen in the patients studied. Further controlled studies are indicated. Clinicians should keep an open mind about possible benefits of these still incompletely studied herbal agents.

  13. International Clinical Trials Registry Platform (ICTRP)

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    @@ Introduction The mission of the WHO Intemational Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.This will improve research transparency and will ultimately strengthen tha validity and value of the scientific evidence base.The registration of all interventional trials is a scientific, ethical and moral responsibility.

  14. Evaluation of new drugs in daily clinical practice : anti-TNFα in rheumatoid arthritis patients

    NARCIS (Netherlands)

    Kievit, Wietske

    2008-01-01

    The objective of this thesis was to explore the value and the validity of data collected in daily clinical practice for drug evaluation and cost-effectiveness studies, using data collected on TNFa blocking agents in rheumatoid arthritis. First, the need for and value of information from daily clinic

  15. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  16. Monitoring clinical trials: a practical guide.

    Science.gov (United States)

    Molloy, Síle F; Henley, Patricia

    2016-12-01

    This article describes the processes and procedures involved in planning, conducting and reporting monitoring activities for large Clinical Trials of Investigational Medicinal Products (CTIMPs), focusing on those conducted in resource-limited settings. © 2016 John Wiley & Sons Ltd.

  17. The New Math of Clinical Trials

    National Research Council Canada - National Science Library

    Jennifer Couzin

    2004-01-01

    ... altering them as they run to take into account accumulating results. Although Bayesian designs are now widely used in everything from astrophysics to ecology, they've been slower to catch on in medical research, particularly clinical trials...

  18. Smart Technology in Lung Disease Clinical Trials.

    Science.gov (United States)

    Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

    2016-01-01

    This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research.

  19. ORIGINAL ARTICLES Pharmacologically active: clinical trials and ...

    African Journals Online (AJOL)

    2008-01-22

    Jan 22, 2008 ... Manufacturers Association, on the basis of a survey of its members ... from this information. The US database, on the other hand, clearly identifies 172 ... workforce involved in clinical trials outside the public sector. This figure ...

  20. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.

    Science.gov (United States)

    Califf, Robert M; Zarin, Deborah A; Kramer, Judith M; Sherman, Rachel E; Aberle, Laura H; Tasneem, Asba

    2012-05-02

    Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials portfolio. To examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database. A data set comprising 96,346 clinical studies from ClinicalTrials.gov was downloaded on September 27, 2010, and entered into a relational database to analyze aggregate data. Interventional trials were identified and analyses were focused on 3 clinical specialties-cardiovascular, mental health, and oncology-that together encompass the largest number of disability-adjusted life-years lost in the United States. Characteristics of registered clinical trials as reported data elements in the trial registry; how those characteristics have changed over time; differences in characteristics as a function of clinical specialty; and factors associated with use of randomization, blinding, and data monitoring committees (DMCs). The number of registered interventional clinical trials increased from 28,881 (October 2004-September 2007) to 40,970 (October 2007-September 2010), and the number of missing data elements has generally declined. Most interventional trials registered between 2007 and 2010 were small, with 62% enrolling 100 or fewer participants. Many clinical trials were single-center (66%; 24,788/37,520) and funded by organizations other than industry or the National Institutes of Health (NIH) (47%; 17,592/37,520). Heterogeneity in the reported methods by clinical specialty; sponsor type; and the reported use of DMCs, randomization, and blinding was evident. For example, reported use of DMCs was less common in industry-sponsored vs NIH-sponsored trials (adjusted odds ratio [OR], 0.11; 95% CI, 0.09-0.14), earlier-phase vs phase 3 trials (adjusted OR, 0

  1. Acute Gout | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute Gou...t E.1.1.1Medical condition in easily understood language Acute Gout E.1.1.2Therapeutic area Diseases [C] - M...n the trial (if it is different from the expected normal treatment of that condition) Acute gout is a self l

  2. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    . Quality was assessed by means of a validated 5-point scale and separate quality components associated with empirical evidence of bias. Only 26% of all RCTs reported sample size calculations, 52% adequate generation of the allocation sequence, 34% adequate allocation concealment and 34% double......, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers...

  3. The utility of clinical decision tools for diagnosing osteoporosis in postmenopausal women with rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Brand Caroline

    2008-01-01

    Full Text Available Abstract Background Patients with rheumatoid arthritis have a higher risk of low bone mineral density than normal age matched populations. There is limited evidence to support cost effectiveness of population screening in rheumatoid arthritis and case finding strategies have been proposed as a means to increase cost effectiveness of diagnostic screening for osteoporosis. This study aimed to assess the performance attributes of generic and rheumatoid arthritis specific clinical decision tools for diagnosing osteoporosis in a postmenopausal population with rheumatoid arthritis who attend ambulatory specialist rheumatology clinics. Methods A cross-sectional study of 127 ambulatory post-menopausal women with rheumatoid arthritis was performed. Patients currently receiving or who had previously received bone active therapy were excluded. Eligible women underwent clinical assessment and dual-energy-xray absorptiometry (DXA bone mineral density assessment. Clinical decision tools, including those specific for rheumatoid arthritis, were compared to seven generic post-menopausal tools to predict osteoporosis (defined as T score Results One hundred and twenty seven women participated. The median age was 62 (IQR 56–71 years. Median disease duration was 108 (60–168 months. Seventy two (57% women had no record of a previous DXA examination. Eighty (63% women had T scores at femoral neck or lumbar spine less than -1. The area under the ROC curve for clinical decision tool prediction of T score Conclusion There was limited utility of clinical decision tools for predicting osteoporosis in this patient population. Fracture prediction tools that include risk factors independent of BMD are needed.

  4. Clinical Trials and their Impact on Society

    Directory of Open Access Journals (Sweden)

    Olga Lidia Cuevas Pérez

    2016-02-01

    Full Text Available Today there are countless examples that illustrate the nature of technoscience, including biotechnology and pharmacology. The clinical trial is the appropriate methodology used by clinical pharmacology to test the efficacy and safety of a treatment or intervention in humans. It constitutes the cornerstone of research. Once the preclinical research is completed, one of the biggest challenges currently facing the Cuban Pharmaceutical and Biotechnological Industry is precisely the clinical evaluation. Therefore, this work aims to provide a reflection on the most significant aspects of clinical trials and their impact on society.

  5. Lessons Learned from Radiation Oncology Clinical Trials

    OpenAIRE

    Liu, Fei-Fei; Okunieff, Paul; Bernhard, Eric J.; Stone, Helen B.; Yoo, Stephen; Coleman, C. Norman; Vikram, Bhadrasain; Brown, Martin; Buatti, John; Guha, Chandan

    2013-01-01

    A Workshop entitled “Lessons Learned from Radiation Oncology Trials” was held on December 7–8th, 2011 in Bethesda, MD, to present and discuss some of the recently conducted Radiation Oncology clinical trials with a focus on those that failed to refute the null hypothesis. The objectives of this Workshop were to summarize and examine the questions that these trials provoked, to assess the quality and limitations of the pre-clinical data that supported the hypotheses underlying these trials, an...

  6. Exercise and manual physiotherapy arthritis research trial (EMPART: a multicentre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Connell Paul

    2009-01-01

    results will contribute to the evidence base regarding the clinical efficacy for physiotherapy interventions in hip OA. Trial Registration Number: NCT00709566

  7. Systemic Arthritis in Children: A Review of Clinical Presentation and Treatment

    Directory of Open Access Journals (Sweden)

    R. Gurion

    2012-01-01

    Full Text Available Systemic juvenile idiopathic arthritis (sJIA constitutes a small part of juvenile idiopathic arthritis (JIA, yet has a disproportionally higher rate of mortality. Despite being grouped under JIA, it is considered to be a multifactorial autoinflammatory disease. The objective of this paper is to review the epidemiology, pathogenesis, genetics, clinical manifestations, complications, therapy, prognosis, and outcome of sJIA. The presentation and clinical manifestations of sJIA have not changed much in the past several decades, but the collective understanding of the pathogenesis and the development of new targeted therapies (particularly the biologic agents have transformed and improved the disease outcome for children with sJIA.

  8. Juvenil idiopatisk arthritis

    DEFF Research Database (Denmark)

    Herlin, Troels

    2002-01-01

    The new classification of juvenile idiopathic arthritis (JIA) is described in this review. Clinical characteristics divide JIA in to subtypes: systemic, oligoarticular (persistent and extended type), RF-positive and--negative polyarticular, enthesitis-related arthritis and psoriatic arthritis...

  9. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  10. CLINICAL AND LABORATORY PROFILE OF POST FEBRILE ARTHRITIS

    Directory of Open Access Journals (Sweden)

    Valluri Satya

    2015-04-01

    Full Text Available We have studied 47 cases out of hundreds of cases with poly arthralgias with o ut signs and symptoms suggestive of typical arthritis over a period of one year i.e., January 2013 to January 2014 out of which 28 cases are women, 19 are men, with history of fever and signs and symptoms of URTI followed by polyarthitis involving small to medium sized joints, and in few with large joints with underlying osteoarthritis with sinovitis. All these patients were evaluated for routine as well as HLAb27,ANA and other viral markers for epidemic arthritis ,out of which one case each of HLAb27 and Chikunguny a Elisa positive, incidentally Rheumatoid factor positive in 3 cases

  11. Clinical Biomarkers and Pathogenic-Related Cytokines in Rheumatoid Arthritis

    OpenAIRE

    Xiaoyin Niu; Guangjie Chen

    2014-01-01

    Rheumatoid arthritis (RA) is a common autoimmune disease with unknown etiology and pathogenesis. Although major therapeutic advances have been made in recent years, there is no cure for the disease. Current medications mainly reduce inflammation in order to relieve pain and slow joint damage, but many have potentially serious side effects. Therefore, to find specific biomarkers will benefit both RA patients to find relief from the disease and physicians to monitor the disease development. A n...

  12. The Effect of Milnacipran on Pain in Rheumatoid Arthritis Patients with Widespread Pain: A Randomized Blinded Crossover Trial

    Science.gov (United States)

    Lee, Yvonne C.; Massarotti, Elena; Edwards, Robert R.; Lu, Bing; Liu, ChihChin; Lo, Yuanyu; Wohlfahrt, Alyssa; Kim, Nancy D.; Clauw, Daniel J.; Solomon, Daniel H.

    2015-01-01

    Objective Clinical trials have shown that serotonin norepinephrine reuptake inhibitors, such as milnacipran, decrease pain in non-inflammatory pain conditions like fibromyalgia and osteoarthritis. We examined the effect of milnacipran on self-reported pain intensity and experimental pain sensitivity among rheumatoid arthritis (RA) patients with widespread pain and stable RA disease activity. Methods In this double-blind, crossover study, RA patients with widespread pain, on a stable treatment regimen, were randomized (via a random number generator) to receive milnacipran 50 mg twice daily or placebo for 6 weeks, followed by a 3-week washout and crossed over to the other arm for the remaining 6 weeks. The primary outcome was change in average pain intensity, assessed by the Brief Pain Inventory short form. The sample size was calculated to detect a 30% improvement in pain with power = 0.80 and alpha = 0.05. Results Of the 43 randomized subjects, 41 received study drug, and 32 completed the 15-week study per protocol. On a 0–10 scale, average pain intensity decreased by 0.39 (95% CI −1.27, 0.49; P = 0.37) more points during 6 weeks of milnacipran treatment compared to placebo. In the subgroup of subjects with swollen joint count ≤ 1, average pain intensity decreased by 1.14 (95% CI −2.26, −0.01; P= 0.04) more points during 6 weeks of milnacipran compared to placebo. Common adverse events included nausea (26.8%) and loss of appetite (9.7%). Conclusion Compared to placebo, milnacipran did not improve overall, self-reported pain intensity among subjects with widespread pain taking stable RA medications. Trial registration: ClinicalTrials.gov NCT01207453 PMID:26628607

  13. An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

    Science.gov (United States)

    Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

    2013-11-01

    To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

  14. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian

    2017-01-03

    The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.

  15. Quantitative Imaging in Cancer Clinical Trials.

    Science.gov (United States)

    Yankeelov, Thomas E; Mankoff, David A; Schwartz, Lawrence H; Lieberman, Frank S; Buatti, John M; Mountz, James M; Erickson, Bradley J; Fennessy, Fiona M M; Huang, Wei; Kalpathy-Cramer, Jayashree; Wahl, Richard L; Linden, Hannah M; Kinahan, Paul E; Zhao, Binsheng; Hylton, Nola M; Gillies, Robert J; Clarke, Laurence; Nordstrom, Robert; Rubin, Daniel L

    2016-01-15

    As anticancer therapies designed to target specific molecular pathways have been developed, it has become critical to develop methods to assess the response induced by such agents. Although traditional, anatomic CT, and MRI examinations are useful in many settings, increasing evidence suggests that these methods cannot answer the fundamental biologic and physiologic questions essential for assessment and, eventually, prediction of treatment response in the clinical trial setting, especially in the critical period soon after treatment is initiated. To optimally apply advances in quantitative imaging methods to trials of targeted cancer therapy, new infrastructure improvements are needed that incorporate these emerging techniques into the settings where they are most likely to have impact. In this review, we first elucidate the needs for therapeutic response assessment in the era of molecularly targeted therapy and describe how quantitative imaging can most effectively provide scientifically and clinically relevant data. We then describe the tools and methods required to apply quantitative imaging and provide concrete examples of work making these advances practically available for routine application in clinical trials. We conclude by proposing strategies to surmount barriers to wider incorporation of these quantitative imaging methods into clinical trials and, eventually, clinical practice. Our goal is to encourage and guide the oncology community to deploy standardized quantitative imaging techniques in clinical trials to further personalize care for cancer patients and to provide a more efficient path for the development of improved targeted therapies.

  16. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

  17. Acute cough | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available ion E.1.1Medical condition(s) being investigated Acute cough Akuter Husten E.1.1.1Medical condition in easily understood language Acu...igation E.1.2Version 17.1 E.1.2Level LLT E.1.2Classification code 10066522 E.1.2Term Acute cough E.1.2System...igible for inclusion in this trial must fulfill all of the following criteria:1. Acute cough with symptoms l...based on medical history and physical examination7. CS score of at least 50 mm on a 100 mm VAS at V1 8. Acute...te cough Akuter Husten E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Dis

  18. [Clinical trials: principles of the method].

    Science.gov (United States)

    Aboulker, J P

    2000-04-15

    Comparative judgement, which is seminal to any kind of science performing measurements, has been applied to clinical reasoning for many centuries. The need for systematizing the observational methods used in medicine in order to draw more reliable inferences about the effects of therapies has been active all along the 19th century. This has resulted in controlled studies which yielded important advances in clinical and therapeutic knowledge, although their designs were not fully satisfactory. Clinical trials have gained their status of "hard science", methodology allowing causal inference, by the end of the 1940s after having adopted the statistical theories developed in the 1930s by Fisher for experimental design in agronomy. A long way has been run since the first controlled randomized trial. However, half a century later, modern clinical trial remains essentially a controlled randomized prospective study using methods to limit potential biases and to establish statistical significance.

  19. [Ethical implications of clinical trials in Tunisia].

    Science.gov (United States)

    Chadly, Ali

    2004-11-01

    Clinical trials are necessary for medical advancement. They must respect legal obligations. Ethical questions related to protection of the human being's rights are yielded by these trials. Joining research to medical core is problematical in consideration of patient's consent to clinical trial. Exclusion by the Tunisian law of persons under age, pregnant or breast-feeding women from medical experimentation in the aim of protecting them against clinical research adverse events or abuses is ethically questionable since it deprives them from a possible medical progress. So why not to involve them in clinical research when there is an expected benefit, after bringing them protection as vulnerable persons like we should do for instance for the elderly, handicapped persons or prisoners. Legal creation of research ethics committees is important for the respect of experimentation rules on human beings.

  20. Involving South Asian patients in clinical trials.

    Science.gov (United States)

    Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P

    2004-10-01

    To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population

  1. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  2. Clinical features of psoriatic arthritis in Korean patients with psoriasis: a cross-sectional observational study of 196 patients with psoriasis using psoriatic arthritis screening questionnaires.

    Science.gov (United States)

    Shin, Dongyun; Kim, Hee Joo; Kim, Dae Suk; Kim, Soo Min; Park, Jin Su; Park, Yong-Beom; Lee, Min-Geol

    2016-02-01

    The prevalence and clinical features of psoriatic arthritis (PsA) in psoriasis patients vary widely in different countries, and studies on Korean population are rarely reported. The aim of this study was to investigate the clinical features of PsA in a Korean population of patients with psoriasis by using psoriatic arthritis screening questionnaires. A cross-sectional observational study was conducted, and consecutive psoriatic patients were evaluated for PsA by using two kinds of psoriatic arthritis screening questionnaires: Psoriatic Arthritis Screening and Evaluation tool (PASE) and Psoriasis Epidemiology Screening Tool (PEST). Psoriatic patients with higher score in screening questionnaires were referred to rheumatologist for confirmative diagnosis of PsA. Among 196 psoriasis patients screened by PASE and PEST, total prevalence of PsA was 11.2 % (n = 22/196) with 59.1 % of the cases being newly diagnosed. Compared with patients without PsA, patients with PsA had more extensive psoriasis, higher frequency of pustular and inverse type of psoriasis, and lower frequency of plaque type of psoriasis. Spondylitis was the most common manifestation pattern, followed by polyarthritis, oligoarthritis, predominant distal interphalangeal arthritis, and arthritis mutilans. Our findings are consistent with a low prevalence of PsA among patients with psoriasis in Asia. We also confirm a spondylitis as the most common pattern of PsA in Korea. PsA screening questionnaires can be a simple and useful tool to screen PsA in patients with psoriasis.

  3. Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Zwinderman, A.H.; Kroon, H.M.; Jansen, A.; Ronday, K.H.; Schaardenburg, D. van; Dijkmans, B.A.C.; Ende, C.H.M. van den; Breedveld, F.C.; Vliet Vlieland, T.P.M.; Hazes, J.M.W.

    2003-01-01

    OBJECTIVE: There are insufficient data on the effects of long-term intensive exercise in patients with rheumatoid arthritis (RA). We undertook this randomized, controlled, multicenter trial to compare the effectiveness and safety of a 2-year intensive exercise program (Rheumatoid Arthritis Patients

  4. RESULTS OF AN OPEN CLINICAL STUDY OF THE EFFICACY OF LEFLUNOMIDE IN RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    I M Marusenko

    2009-06-01

    Conclusion. The new basic drug leflunomide is as effective as the gold standard methotrexate, at the same time it allows clinical improvement to be more rapidly achieved. Leflunomide also slows down the rate of progression of erosive arthritis and it is well tolerated.

  5. The clinical course of juvenile idiopathic arthritis-associated uveitis in childhood and puberty

    NARCIS (Netherlands)

    Hoeve, Maretta; Ayuso, Viera Kalinina; Schalij-Delfos, Nicoline E.; Los, Leonoor I.; Rothova, Aniki; de Boer, Joke H.

    2012-01-01

    Aim The long-term course of juvenile idiopathic arthritis (JIA)-associated uveitis is not known yet. This study investigates the course and activity of JIA-associated uveitis in childhood and puberty. Design Retrospective study of the clinical data of 62 JIA patients with uveitis. The main outcome m

  6. Clinical and Serological Findings in Juvenile Patients with Idiopathic Arthritis in Southwestern of Iran

    Directory of Open Access Journals (Sweden)

    Soheila Alyasin

    2014-10-01

    Full Text Available Introduction: The purpose of this study was to describe clinical features and serological findings of children with idiopathic arthritis in south-western Iran.Methods: This descriptive study included 60 patients with juvenile idiopathic arthritis who were referred to a pediatric rheumatology clinic at a university hospital during 6-month period. Initial manifestations, first laboratory tests and clinical course of patients were reviewed.Results: Sixty children (32 boys and 28 girls with idiopathic arthritis ranged in age from 1.5 to 16 years. The mean age at the first presentation was 4.92 years (SD= 3.68. Oligoarthritis was the most common subtype in 27 (45%, followed by systemic- onset in 17 (28.3% and polyarthritis in 16 (26.7% of patients. The most commonly involved joints were knee 53(88.3%, ankle 28(46.6% and wrist 27(45%. Uveitis was detected in two patients, and positivity for ANA titer was revealed in one patient. Conclusions: In this study, the pattern of most clinical features in different subtypes of juvenile idiopathic arthritis resembles to other studies. Positive ANA was less; however, the low numbers of Iranian patients with uveitis was noteworthy.

  7. The clinical course of juvenile idiopathic arthritis-associated uveitis in childhood and puberty

    NARCIS (Netherlands)

    Hoeve, Maretta; Ayuso, Viera Kalinina; Schalij-Delfos, Nicoline E.; Los, Leonoor I.; Rothova, Aniki; de Boer, Joke H.

    2012-01-01

    Aim The long-term course of juvenile idiopathic arthritis (JIA)-associated uveitis is not known yet. This study investigates the course and activity of JIA-associated uveitis in childhood and puberty. Design Retrospective study of the clinical data of 62 JIA patients with uveitis. The main outcome m

  8. Septic arthritis: a 12 years retrospective study in a rheumatological university clinic

    Directory of Open Access Journals (Sweden)

    L. Riato

    2011-09-01

    Full Text Available Background: Septic arthritis is a disabling and potentially life-threatening condition that requires prompt diagnosis and treatment. The most important risk factors are joint prosthesis, pre-existing joint disease and immunosuppressive drugs. The aim of our study therefore was to revaluate all septic arthritis cases discharged from our Rheumatologic Unit in the last 12 years, to assess the risk factors, the clinical and laboratory characteristics, the causative microorganisms and its possible increase in frequency. Methods: The medical records of 42 consecutive patients with septic arthritis discharged from our Rheumatology Unit between January 1995 and December 2006 were reviewed. The patients ranged in age from 23 to 90 and there isn’t gender predominance. Septic arthritis was diagnosed based on the finding of purulent material in the joint space and/or the isolation of a bacterial pathogen from joint fluid. Demographic data, risk factors, co-morbidity, clinical manifestations, time interval between symptoms onset and diagnosis, treatment and laboratory data including serum white blood cell count, erythrocyte sedimentation rate (ESR, C reactive protein (CRP, synovial white blood cells and culture results were analysed. We considered these parameters in the whole population and in two different age groups (≤60, >60 and tried to determine if there was a change of microorganisms involved in septic arthritis during the years. Results: Of 42 patients, 47% were aged 60 and younger. Only 10 patients were admitted to our unit before 2001. A predisposing factor was recorded in 90,5% of cases: 15 patients had rheumatoid arthritis, 8 were diabetic, 6 had seronegative arthritis, 4 had a connective tissue disease, 8 patients had a prosthetic infection and 3 were subjected recently to arthrocentesis. We found that patients aged 60 and younger were more frequently affected by joint disease and had a synovial white blood cell count lower than patients

  9. Clinical trial networks in orthopaedic surgery.

    Science.gov (United States)

    Rangan, A; Jefferson, L; Baker, P; Cook, L

    2014-05-01

    The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs. Cite this article: Bone Joint Res 2014;3:169-74. ©2014 The British Editorial Society of Bone & Joint Surgery.

  10. An update on the pathology and clinical management of gouty arthritis.

    Science.gov (United States)

    Gonzalez, Emilio B

    2012-01-01

    Gouty arthritis is an inflammatory condition associated with debilitating clinical symptoms, functional impairments, and a substantial impact on quality of life. This condition is initially triggered by the deposition of monosodium urate crystals into the joint space. This causes an inflammatory cascade resulting in the secretion of several proinflammatory cytokines and neutrophil recruitment into the joint. While generally effective, currently available agents are associated with a number of adverse events and contraindications that complicate their use. Based on our increased understanding of the inflammatory pathogenesis of gouty arthritis, several new agents are under development that may provide increased efficacy and reduced toxicity.

  11. Periodontal disease, Porphyromonas gingivalis, and rheumatoid arthritis: what triggers autoimmunity and clinical disease?

    Science.gov (United States)

    Scher, Jose U; Abramson, Steven B

    2013-01-01

    Rheumatoid arthritis, currently regarded as a complex multifactorial disease, was initially characterized as such at the turn of the 19th century. Ever since, multiple lines of investigation have attempted to elucidate the etiological factor(s) involved in disease incidence. Genes--including those risk alleles within HLA-DR4--have been implicated but are insufficient to explain the vast majority of cases. Several environmental factors, therefore, are being studied. Among them, the role of periodontal disease and Porphyromonas gingivalis in the pathogenesis of rheumatoid arthritis has attracted both clinical and bench interest given supportive epidemiologic and mechanistic data.

  12. Marine oil supplements for arthritis pain

    DEFF Research Database (Denmark)

    Senftleber, Ninna K.; Nielsen, Sabrina M.; Andersen, Jens Rikardt;

    2017-01-01

    Arthritis patients often take fish oil supplements to alleviate symptoms, but limited evidence exists regarding their efficacy. The objective was to evaluate whether marine oil supplements reduce pain and/or improve other clinical outcomes in patients with arthritis. Six databases were searched...... systematically (24 February 2015). We included randomized trials of oral supplements of all marine oils compared with a control in arthritis patients. The internal validity was assessed using the Cochrane Risk of Bias tool and heterogeneity was explored using restricted maximum of likelihood (REML)-based meta...... interval, CI, -0.42 to -0.07; heterogeneity, I2 = 63%. A significant effect was found in patients with rheumatoid arthritis (22 trials; -0.21; 95% CI, -0.42 to -0.004) and other or mixed diagnoses (3 trials; -0.63; 95% CI, -1.20 to -0.06), but not in osteoarthritis patients (5 trials; -0.17; 95% CI, -0...

  13. Marine oil supplements for arthritis pain

    DEFF Research Database (Denmark)

    Senftleber, Ninna K.; Nielsen, Sabrina M.; Andersen, Jens Rikardt

    2017-01-01

    Arthritis patients often take fish oil supplements to alleviate symptoms, but limited evidence exists regarding their efficacy. The objective was to evaluate whether marine oil supplements reduce pain and/or improve other clinical outcomes in patients with arthritis. Six databases were searched...... systematically (24 February 2015). We included randomized trials of oral supplements of all marine oils compared with a control in arthritis patients. The internal validity was assessed using the Cochrane Risk of Bias tool and heterogeneity was explored using restricted maximum of likelihood (REML)-based meta...... interval, CI, -0.42 to -0.07; heterogeneity, I2 = 63%. A significant effect was found in patients with rheumatoid arthritis (22 trials; -0.21; 95% CI, -0.42 to -0.004) and other or mixed diagnoses (3 trials; -0.63; 95% CI, -1.20 to -0.06), but not in osteoarthritis patients (5 trials; -0.17; 95% CI, -0...

  14. The AIDS Clinical Trials Information Service (ACTIS): a decade of providing clinical trials information.

    Science.gov (United States)

    Katz, Deborah G; Dutcher, Gale A; Toigo, Theresa A; Bates, Ruthann; Temple, Freda; Cadden, Cynthia G

    2002-01-01

    The AIDS Clinical Trials Information Service (ACTIS) is a central resource for information about federally and privately funded HIV/AIDS clinical trials. Sponsored by four components of the U.S. Department of Health and Human Services, ACTIS has been a key part of U.S. HIV/AIDS information and education services since 1989. ACTIS offers a toll-free telephone service, through which trained information specialists can provide callers with information about AIDS clinical trials in English or Spanish, and a website that provides access to clinical trials databases and a variety of educational resources. Future priorities include the development of new resources to target diverse and underserved populations. In addition, research needs to be conducted on the use of telephone services vs. Web-based information exchange to ensure the broadest possible dissemination of up-to-date information on HIV infection and clinical trials.

  15. [Clinical observation of traumatic ankle arthritis with orthopedics lotion on 60 cases].

    Science.gov (United States)

    Zhang, Hui; Yu, Jie

    2014-02-01

    Observing the clinical curative effect of orthopedics lotion to treat traumatic ankle arthritis, the outpatient department of orthopedics in Guang'anmen Hospital collected 60 cases who were diagnosed as traumatic ankle arthritis. The cases who already met the inclusion criteria, were randomly divided into the treatment group (30 cases) and control group (30 cases). Thirty patients in treatment group were received fumigation treatment with orthopedics lotion; 30 patients in control group were treated by intra-articular injection of sodium hyaluronate. After 5 weeks treatment, the effects on the both groups would be observed and analysed. Baird-Jackson scoring system was used to assess the overall curative effect. Visual analogue scales (VAS) was used to assess analgesic effect. BJ scores of pre-treatment and post-treatment in both the treatment group and the control group were compared, P orthopedics lotion is a effective way to treat traumatic ankle arthritis, and it has significant effect on analgesic.

  16. Using e-technologies in clinical trials.

    Science.gov (United States)

    Rosa, Carmen; Campbell, Aimee N C; Miele, Gloria M; Brunner, Meg; Winstanley, Erin L

    2015-11-01

    Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored.

  17. Antibodies specific for carbamylated proteins precede the onset of clinical symptoms in mice with collagen induced arthritis.

    Directory of Open Access Journals (Sweden)

    Jeroen N Stoop

    Full Text Available OBJECTIVE: The immune response to post-translationally modified antigens is a key characteristic of rheumatoid arthritis. Carbamylation is such a posttranslational modification. Recently, we demonstrated that autoantibodies recognizing carbamylated proteins are present in sera of rheumatoid arthritis. The molecular mechanisms underlying the break of tolerance and hence the induction of anti-CarP antibody responses are unknown as well as their appearance in mouse models for systemic arthritis. Therefore we analyzed their appearance in the mouse collagen-induced arthritis model. METHODS: collagen induced arthritis was induced by immunization with type II collagen in complete Freund's adjuvant. Arthritis severity was monitored by clinical scoring and anti-CarP antibody levels were determined by ELISA. RESULTS: Anti-CarP antibodies were detectable in mice with collagen induced arthritis. We did not detect ACPA in mice with collagen induced arthritis. The specificity of the antibodies for carbamylated proteins was confirmed by inhibition assays and immunoblotting. Injection with complete Freund's adjuvant without type II collagen could also induce anti-CarP antibodies, however, in mice with arthritis, the anti-CarP antibody response was stronger and developed more rapidly. The onset of collagen induced arthritis was preceded by an increase of anti-CarP IgG2a levels in the serum. CONCLUSION: In mice with collagen induced arthritis we did not observe an immune response against citrullinated antigens, but we did observe an immune response against carbamylated antigens. This anti-CarP response already appeared before disease onset, indicating that collagen induced arthritis can be used as an in vivo model to study anti-CarP antibodies. Our data also indicate that the tolerance to carbamylated proteins, in contrast to the response to citrullinated proteins, is easily broken and that arthritis boosts the immune response against these proteins. The anti

  18. [Clinical trials with advanced therapy medicinal products].

    Science.gov (United States)

    Schüssler-Lenz, M; Schneider, C K

    2010-01-01

    For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as medicinal products or medical devices. Thus, for some products no data from clinical studies are available, e.g., for autologous chondrocyte products. The draft guideline on Good Clinical Practice for clinical trials with advanced therapies describes specific additional requirements, e.g., ensuring traceability. Most clinical studies with advanced therapies in Germany are still in early phase I or II trials with highly divergent types of products and clinical indications. The Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMEA) has been established to meet the scientific and regulatory challenges with advanced therapies.

  19. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  20. Clinical Trials in Male Hormonal Contraception

    Directory of Open Access Journals (Sweden)

    Nieschlag E

    2011-01-01

    Full Text Available Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers.

  1. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton;

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...

  2. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton;

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and k...

  3. Most Trial Eligibility Criteria and Patient Baseline Characteristics Do Not Modify Treatment Effect in Trials Using Targeted Therapies for Rheumatoid Arthritis

    DEFF Research Database (Denmark)

    Christensen, Anton Wulf; Tarp, Simon; Furst, Daniel E;

    2015-01-01

    )) for rheumatoid arthritis (RA). METHODS: We conducted a meta-epidemiological study of all trials evaluating a targeted therapy approved by regulatory authorities for treating RA. The database search was completed on December 11th 2013. Eligible trials reported ACR20 data at months 3-6 and used an add-on design......OBJECTIVE: To determine if variations in trial eligibility criteria and patient baseline characteristics could be considered effect modifiers of the treatment response when testing targeted therapies (biological agents and targeted synthetic disease modifying antirheumatic drugs (DMARDs...

  4. Mining disease risk patterns from nationwide clinical databases for the assessment of early rheumatoid arthritis risk.

    Science.gov (United States)

    Chin, Chu Yu; Weng, Meng Yu; Lin, Tzu Chieh; Cheng, Shyr Yuan; Yang, Yea Huei Kao; Tseng, Vincent S

    2015-01-01

    Rheumatoid arthritis (RA) is a chronic autoimmune rheumatic disease that can cause painful swelling in the joint lining, morning stiffness, and joint deformation/destruction. These symptoms decrease both quality of life and life expectancy. However, if RA can be diagnosed in the early stages, it can be controlled with pharmacotherapy. Although many studies have examined the possibility of early assessment and diagnosis, few have considered the relationship between significant risk factors and the early assessment of RA. In this paper, we present a novel framework for early RA assessment that utilizes data preprocessing, risk pattern mining, validation, and analysis. Under our proposed framework, two risk patterns can be discovered. Type I refers to well-known risk patterns that have been identified by existing studies, whereas Type II denotes unknown relationship risk patterns that have rarely or never been reported in the literature. These Type II patterns are very valuable in supporting novel hypotheses in clinical trials of RA, and constitute the main contribution of this work. To ensure the robustness of our experimental evaluation, we use a nationwide clinical database containing information on 1,314 RA-diagnosed patients over a 12-year follow-up period (1997-2008) and 965,279 non-RA patients. Our proposed framework is employed on this large-scale population-based dataset, and is shown to effectively discover rich RA risk patterns. These patterns may assist physicians in patient assessment, and enhance opportunities for early detection of RA. The proposed framework is broadly applicable to the mining of risk patterns for major disease assessments. This enables the identification of early risk patterns that are significantly associated with a target disease.

  5. Biomarkers in T cell therapy clinical trials

    Directory of Open Access Journals (Sweden)

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  6. Antibodies to Infliximab and Adalimumab in Patients with Rheumatoid Arthritis in Clinical Remission

    DEFF Research Database (Denmark)

    Eng, Grith P; Bendtzen, Klaus; Bliddal, Henning;

    2015-01-01

    Objective. To investigate if antibodies towards biological TNF-α inhibitors (anti-TNFi Abs) are present in patients with rheumatoid arthritis (RA) in clinical remission and to relate any anti-TNFi Abs to circulating level of TNF-α inhibitor (TNFi). Methods. Patients with RA, treated with infliximab....... These data suggest that continued infliximab treatment may be redundant in a proportion of RA patients treated with infliximab and in clinical remission....

  7. Clobazam: uncontrolled and standard controlled clinical trials.

    Science.gov (United States)

    Ban, T A; Amin, M M

    1979-01-01

    1 In an uncontrolled clinical trial, carried out in 11 psychiatric patients with the clinical diagnoses of anxiety neurosis and depressive neurosis, clobazam, a new benzodiazepine preparation, in the dosage range 10-60 mg daily produced statistically significant improvement in the total and both factor scores of the Hamilton Anxiety Scale (HAM-A). The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 48 mg daily. 2 Results of the uncontrolled clinical trial were further substantiated in a standard-controlled clinical study in which no statistically significant difference between the therapeutic effectiveness of clobazam and diazepam could be revealed. The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 49 mg daily. There was a lower incidence of adverse effects reported in patients receiving clobazam than in those taking the control drug (diazepam).

  8. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Craig Fiona F

    2012-04-01

    Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

  9. Gene therapy for arthritis: progress towards a clinical trial

    OpenAIRE

    Aalbers, C.J.

    2015-01-01

    De afgelopen twee decennia heeft de behandeling van reumatoïde artritis (RA) een vlucht genomen. Het huidige arsenaal aan anti-reumatica heeft voor veel patiënten een enorme verbetering opgeleverd, echter niet voor iedereen. Volledige remissie wordt bij slechts een minderheid van de patiënten bereikt, waarbij veel patiënten nog steeds één of meerdere ontstoken gewrichten overhouden. Omdat de plaats van ontsteking bij RA het gewricht is, lijkt intra-articulaire behandeling een logische keuze v...

  10. Novel ocular antihypertensive compounds in clinical trials

    Directory of Open Access Journals (Sweden)

    Chen J

    2011-05-01

    Full Text Available June Chen1, Stephen A Runyan1, Michael R Robinson21Department of Biological Sciences, 2Ophthalmology Clinical Research, Allergan, Inc, Irvine, CA, USAIntroduction: Glaucoma is a multifactorial disease characterized by progressive optic nerve injury and visual field defects. Elevated intraocular pressure (IOP is the most widely recognized risk factor for the onset and progression of open-angle glaucoma, and IOP-lowering medications comprise the primary treatment strategy. IOP elevation in glaucoma is associated with diminished or obstructed aqueous humor outflow. Pharmacotherapy reduces IOP by suppressing aqueous inflow and/or increasing aqueous outflow.Purpose: This review focuses on novel non-FDA approved ocular antihypertensive compounds being investigated for IOP reduction in ocular hypertensive and glaucoma patients in active clinical trials within approximately the past 2 years.Methods: The mode of IOP reduction, pharmacology, efficacy, and safety of these new agents were assessed. Relevant drug efficacy and safety trials were identified from searches of various scientific literature databases and clinical trial registries. Compounds with no specified drug class, insufficient background information, reformulations, and fixed-combinations of marketed drugs were not considered.Results: The investigational agents identified comprise those that act on the same targets of established drug classes approved by the FDA (ie, prostaglandin analogs and β-adrenergic blockers as well as agents belonging to novel drug classes with unique mechanisms of action. Novel targets and compounds evaluated in clinical trials include an actin polymerization inhibitor (ie, latrunculin, Rho-associated protein kinase inhibitors, adenosine receptor analogs, an angiotensin II type 1 receptor antagonist, cannabinoid receptor agonists, and a serotonin receptor antagonist.Conclusion: The clinical value of novel compounds for the treatment of glaucoma will depend

  11. Stromal cells and osteoclasts are responsible for exacerbated collagen-induced arthritis in interferon-beta-deficient mice

    DEFF Research Database (Denmark)

    Treschow, Alexandra P; Teige, Ingrid; Nandakumar, Kutty S;

    2005-01-01

    OBJECTIVE: Clinical trials using interferon-beta (IFNbeta) in the treatment of rheumatoid arthritis have shown conflicting results. We undertook this study to understand the mechanisms of IFNbeta in arthritis at a physiologic level. METHODS: Collagen-induced arthritis (CIA) was induced in IFNbeta...

  12. Lung Cancer Clinical Trials: Advances in Immunotherapy

    Science.gov (United States)

    New treatments for lung cancer and aspects of joining a clinical trial are discussed in this 30-minute Facebook Live event, hosted by NCI’s Dr. Shakun Malik, head of thoracic oncology therapeutics, and Janet Freeman-Daily, lung cancer patient activist and founding member of #LCSM.

  13. USE OF SUBCUTANEOUS METHOTREXATE FOR THE TREATMENT OF PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: THE REMARCA TRIAL

    Directory of Open Access Journals (Sweden)

    D. E. Karateev

    2016-01-01

    Full Text Available The early administration of methotrexate (MTX and the use of its high (by the rheumatology practice standards doses contribute to the enhanced efficiency of therapy and the reduced severity of rheumatoid arthritis (RA. One of the important merits of MTX in the treatment of RA is the possibility of adjusting its dose and choosing its (oral or subcutaneous administration routes, which makes it possible to individualize treatment. Particular emphasis has been recently placed just on a subcutaneous MTX formulation that creates prerequisites for substantially improving the efficiency of RA therapy. The paper gives the data of the REMARCA (Russian investigation of methotrexate and biologicals for early active arthritis trial assessing the results of RA treatment in the use of the subcutaneous MTX dosage form as a first-line drug and in the elaboration of management tactics for this disease.Subjects and methods. The investigation included 191 patients (34 men and 157 women with active RA; of whom 51.8% had very early RA (< 6 months' disease duration. 115 patients with RA completed a 24-month follow-up period; and their data were analyzed in more detail.Results and discussion. The findings may substantiate treatment policy based on the prescription of subcutaneous MTX (without previously administering its oral formulation in patients with early RA and high disease activity, starting the drug at 15 mg/week and rapidly escalating with the highest tolerable doses during 4-8 weeks, which allows remission (or low disease activity in the majority of patients without using glucocorticoids and biological agents.

  14. Prevalence and clinical features of arthralgia/arthritis in healthy pregnant women.

    Science.gov (United States)

    Choi, Hyo Jin; Lee, Jung Chan; Lee, Yun Jong; Lee, Eun Bong; Shim, Soon Sup; Park, Joong Shin; Jun, Jong Kwan; Song, Yeong Wook

    2008-09-01

    The authors prospectively investigated 155 pregnant women, without a history of rheumatic disease who visited the Department of Obstetrics and Gynecology for routine antenatal care, to evaluate the prevalences and clinical features of arthralgia and arthritis in healthy pregnant women. Mean of the 155 subjects' ages was 31.8 +/- 3.8 (years, +/-SD). Arthralgia was found in 26 (16.7%) and arthritis in 15 (9.6%) pregnant women. Arthralgia or arthritis developed in the third trimester (28-40 weeks of gestation), except in one case (16 weeks of gestation). Most commonly involved joints were the proximal interphalangeal (n = 19, 12.2%). Rheumatoid factor and antinuclear antibody were negative in patients with arthritis. Ten women (6.8%) had persistent arthralgia for over 6 weeks, post-delivery. Four of them were followed up at Rheumatology Clinic and were diagnosed as having spondyloarthropathy (1), or unspecified arthralgia (3). In conclusion, arthralgia is common during pregnancy and most frequent in proximal interphalangeal joints.

  15. Two to five repeated measurements per patient reduced the required sample size considerably in a randomized clinical trial for patients with inflammatory rheumatic diseases

    OpenAIRE

    Smedslund Geir; Zangi Heidi Andersen; Mowinckel Petter; Hagen Kåre Birger

    2013-01-01

    Abstract Background Patient reported outcomes are accepted as important outcome measures in rheumatology. The fluctuating symptoms in patients with rheumatic diseases have serious implications for sample size in clinical trials. We estimated the effects of measuring the outcome 1-5 times on the sample size required in a two-armed trial. Findings In a randomized controlled trial that evaluated the effects of a mindfulness-based group intervention for patients with inflammatory arthritis (n=71)...

  16. Strengthening and stretching for rheumatoid arthritis of the hand (SARAH: design of a randomised controlled trial of a hand and upper limb exercise intervention - ISRCTN89936343

    Directory of Open Access Journals (Sweden)

    Adams Jo

    2012-11-01

    Full Text Available Abstract Background Rheumatoid Arthritis (RA commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA. Methods/design 480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel. Discussion This paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care. Trial registration Current Controlled Trials ISRCTN89936343

  17. Information on blinding in registered records of clinical trials

    Directory of Open Access Journals (Sweden)

    Viergever Roderik F

    2012-11-01

    Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

  18. Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database

    Science.gov (United States)

    Subherwal, Sumeet; Patel, Manesh R.; Chiswell, Karen; Tidemann-Miller, Beth A.; Jones, W. Schuyler; Conte, Michael S.; White, Christopher J.; Bhatt, Deepak L.; Laird, John R.; Hiatt, William R.; Tasneem, Asba; Califf, Robert M.

    2014-01-01

    Background Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); however, until recently it has not been possible to examine the entire clinical trial portfolio of studies for treatment of PVD (both arterial and venous disease). Methods and Results We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower extremity peripheral artery disease and acute stroke (35% and 24%, respectively), while most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients aged >65 years. Enrollment in at least 1 US site decreased from 51% in 2007 to 41% of trials in 2010. Compared with non-cardiology disciplines, PVD trials were more likely to be double-blinded, investigate use of devices and procedures, and have industry sponsorship and assumed funding source, and less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. Conclusions PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD. PMID:25239436

  19. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.

    Science.gov (United States)

    Kloppenburg, M; Maheu, E; Kraus, V B; Cicuttini, F; Doherty, M; Dreiser, R-L; Henrotin, Y; Jiang, G-L; Mandl, L; Martel-Pelletier, J; Nelson, A E; Neogi, T; Pelletier, J-P; Punzi, L; Ramonda, R; Simon, L S; Wang, S

    2015-05-01

    Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future.

  20. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2009-01-01

    Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.

  1. Prostate cancer vaccines in clinical trials.

    Science.gov (United States)

    Lubaroff, David M

    2012-07-01

    This review presents important information about the current state of the art for vaccine immunotherapy of prostate cancer. It includes important preclinical research for each of the important prostate cancer vaccines to have reached clinical trials. To date, the only prostate cancer vaccine that has completed Phase III trials and has been approved and licensed by the US FDA is Sipuleucel-T, which immunizes patients against the prostate-associated antigen prostatic acid phosphatase. The benefits and concerns associated with the vaccine are presented. A current Phase III trial is currently underway using the vaccinia-based prostate-specific antigen vaccine Prostvac-TRICOM. Other immunotherapeutic vaccines in trials include the Ad/prostate-specific antigen vaccine Ad5-prostate-specific antigen and the DNA/prostatic acid phosphatase vaccine. A cellular vaccine, GVAX, has been in clinical trials but has not seen continuous study. This review also delves into the multiple immune regulatory elements that must be overcome in order to obtain strong antitumor-associated antigen immune responses capable of effectively destroying prostate tumor cells.

  2. Randomized controlled trial of a nurse-led rheumatology clinic for monitoring biological therapy.

    Science.gov (United States)

    Larsson, Ingrid; Fridlund, Bengt; Arvidsson, Barbro; Teleman, Annika; Bergman, Stefan

    2014-01-01

    To compare and evaluate the treatment outcomes of a nurse-led rheumatology clinic and a rheumatologist-led clinic in patients with low disease activity or in remission who are undergoing biological therapy. Patients with chronic inflammatory arthritis treated with biological therapy are usually monitored by rheumatologists. Nurse-led rheumatology clinics have been proposed in patients with low disease activity or in remission. Randomized controlled trial. A 12-month follow-up trial was conducted between October 2009 and August 2011, where 107 patients were randomized into two groups with a 6-month follow-up to a nurse-led rheumatology clinic based on person-centred care (intervention group; n = 53) or to a rheumatologist-led clinic (control group; n = 54). The hypothesis was that the nurse-led clinic outcomes would not be inferior to those obtained from a rheumatologist-led clinic at the 12-month follow-up. The primary outcome was disease activity measured by Disease Activity Score 28. A total of 47 patients in the intervention group and 50 in the control group completed the 12-month trial. The trial revealed no statistically significant differences between groups in mean change of Disease Activity Score 28, Visual Analogue Scales for pain, the Health Assessment Questionnaire, satisfaction with or confidence in obtaining rheumatology care. Patients with stable chronic inflammatory arthritis undergoing biological therapy could be monitored by a nurse-led rheumatology clinic without difference in outcome as measured by the Disease Activity Score 28. © 2013 The Authors. Journal of Advanced Nursing published by John Wiley & Sons Ltd.

  3. Optimizing biologically targeted clinical trials for neurofibromatosis.

    Science.gov (United States)

    Gutmann, David H; Blakeley, Jaishri O; Korf, Bruce R; Packer, Roger J

    2013-04-01

    The neurofibromatoses (neurofibromatosis type 1, NF1 and neurofibromatosis type 2, NF2) comprise the most common inherited conditions in which affected children and adults develop tumors of the central and peripheral nervous system. In this review, the authors discuss how the establishment of the Neurofibromatosis Clinical Trials Consortium (NFCTC) has positively impacted on the design and execution of treatment studies for individuals with NF1 and NF2. Using an extensive PUBMED search in collaboration with select NFCTC members expert in distinct NF topics, the authors discuss the clinical features of NF1 and NF2, the molecular biology of the NF1 and NF2 genes, the development and application of clinically relevant Nf1 and Nf2 genetically engineered mouse models and the formation of the NFCTC to enable efficient clinical trial design and execution. The NFCTC has resulted in a more seamless integration of mouse preclinical and human clinical trials efforts. Leveraging emerging enabling resources, current research is focused on identifying subtypes of tumors in NF1 and NF2 to deliver the most active compounds to the patients most likely to respond to the targeted therapy.

  4. Analysis of opioid consumption in clinical trials

    DEFF Research Database (Denmark)

    Juul, Rasmus Vestergaard; Nyberg, Joakim; Kreilgaard, Mads

    2017-01-01

    Inconsistent trial design and analysis is a key reason that few advances in postoperative pain management have been made from clinical trials analyzing opioid consumption data. This study aimed to compare four different approaches to analyze opioid consumption data. A repeated time-to-event (RTTE...... of potency was obtained with a RTTE model accounting for both morphine effects and time-varying covariates on opioid consumption. An RTTE analysis approach proved better suited for demonstrating efficacy of opioid sparing analgesics than traditional statistical tests as a lower sample size was required due...

  5. Massage Therapy for Pain and Function in Patients With Arthritis: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Nelson, Nicole L; Churilla, James R

    2017-09-01

    Massage therapy is gaining interest as a therapeutic approach to managing osteoarthritis and rheumatoid arthritis symptoms. To date, there have been no systematic reviews investigating the effects of massage therapy on these conditions. Systematic review was used. The primary aim of this review was to critically appraise and synthesize the current evidence regarding the effects of massage therapy as a stand-alone treatment on pain and functional outcomes among those with osteoarthritis or rheumatoid arthritis. Relevant randomized controlled trials were searched using the electronic databases Google Scholar, MEDLINE, and PEDro. The PEDro scale was used to assess risk of bias, and the quality of evidence was assessed with the GRADE approach. This review found seven randomized controlled trials representing 352 participants who satisfied the inclusion criteria. Risk of bias ranged from four to seven. Our results found low- to moderate-quality evidence that massage therapy is superior to nonactive therapies in reducing pain and improving certain functional outcomes. It is unclear whether massage therapy is more effective than other forms of treatment. There is a need for large, methodologically rigorous randomized controlled trials investigating the effectiveness of massage therapy as an intervention for individuals with arthritis.

  6. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design

    OpenAIRE

    Lammertse, D; Tuszynski, MH; Steeves, JD; Curt, A; Fawcett, JW; Rask, C; Ditunno, JF; Fehlings, MG; Guest, JD; Ellaway, PH; Kleitman, N; Blight, AR; Dobkin, BH; Grossman, R.; Katoh, H.

    2006-01-01

    The International Campaign for Cures of Spinal Cord Injury Paralysis established a panel tasked with reviewing the methodology for clinical trials for spinal cord injury (SCI), and making recommendations on the conduct of future trials. This is the fourth of four papers. Here, we examine the phases of a clinical trial program, the elements, types, and protocols for valid clinical trial design. The most rigorous and valid SCI clinical trial would be a prospective double-blind randomized contro...

  7. Plasma n-3 fatty acids and clinical outcomes in recent-onset rheumatoid arthritis.

    Science.gov (United States)

    Proudman, Susanna M; Cleland, Leslie G; Metcalf, Robert G; Sullivan, Thomas R; Spargo, Llewellyn D; James, Michael J

    2015-09-28

    A randomised controlled trial (RCT) of high-dose v. low-dose fish oil in recent-onset rheumatoid arthritis (RA) demonstrated that the group allocated to high-dose fish oil had increased remission and decreased failure of disease-modifying anti-rheumatic drug (DMARD) therapy. This study examines the relationships between plasma phospholipid levels of the n-3 fatty acids in fish oil, EPA and DHA, and remission and DMARD use in recent-onset RA. EPA and DHA were measured in blood samples from both groups of the RCT. The data were analysed as a single cohort, and Cox proportional hazards models were used to examine relationships between plasma phospholipid (PL) EPA and DHA and various outcome measures. When analysed as a single cohort, plasma PL EPA was related to time to remission, with a one unit increase in EPA (1% total fatty acids) associated with a 12% increase in the probability of remission at any time during the study period (hazard ratio (HR)=1.12; 95% CI 1.02, 1.23; P=0.02). Adjustment for smoking, anti-cyclic citrullinated peptide antibodies and 'shared epitope' HLA-DR allele status did not change the HR. Plasma PL EPA, adjusted for the same variables, was negatively related to time to DMARD failure (HR=0.85; 95% CI 0.72, 0.99; P=0.047). The HR for DHA and time to remission or DMARD failure were similar in magnitude to those for EPA, but not statistically significant. Biomarkers of n-3 status, such as plasma PL EPA, have the potential to predict clinical outcomes relevant to standard drug treatment of RA patients.

  8. Clinical significance in detection of inflammatory cytokines in rheumatoid arthritis patients

    Institute of Scientific and Technical Information of China (English)

    Liang-Qian Wang; Yang Tang; Xiu-Yang Li; Da-Jun Liu

    2016-01-01

    Objective:To investigate the relationship between inflammatory cytokines and rheumatoid arthritis, and explore the clinical application value of cytokines in the diagnosis, treatment and prognosis of rheumatoid arthritis.Methods:A total of 136 cases of patients with rheumatoid arthritis were regarded as the RA group. Among them, 62 patients were in remission and 74 patients were in the active phase of the disease. Besides, 53 cases of healthy volunteers were considered as the control group. The changes of the IL-1β, IL-6, IL-8, IL-10 and IFN-γ of the three groups were compared and the correlation of the inflammatory cytokines in patients with rheumatoid arthritis, DSA28 score and C-reactive protein would be explored. Results:The IL-1β and IFN-γ of patients in remission in the RA group showed no statistical differences as compared with those of the control group; the IL-1β and IFN-γ of patients in the active phase of the disease in the RA group presented statistical differences as compared with those of patients in the control group and patients in remission in the RA group; The IL-6, IL-8 and IL-10 were compared in pairs and all showed statistical differences; CRP and DSA28 score and IL-6, IL-8 and IL-10 were positively correlated, while IL-1β, IFN-γ and CRP and DSA 28 score had no correlations.Conclusions:It is of important significance in the clinic to detect inflammatory cytokines in the early diagnosis, disease evaluation and prognostic prediction of rheumatoid arthritis.

  9. Use of Complementary Therapies Among Primary Care Clinic Patients With Arthritis

    Directory of Open Access Journals (Sweden)

    Carla J. Herman

    2004-10-01

    Full Text Available Introduction Use of complementary and alternative medicine (CAM for chronic conditions has increased in recent years. There is little information, however, on CAM use among adults with clinic-confirmed diagnoses, including arthritis, who are treated by primary care physicians. Methods To assess the frequency and types of CAM therapy used by Hispanic and non-Hispanic white women and men with osteoarthritis, rheumatoid arthritis, or fibromyalgia, we used stratified random selection to identify 612 participants aged 18–84 years and seen in university-based primary care clinics. Respondents completed an interviewer-administered survey in English or Spanish. Results Nearly half (44.6% of the study population was of Hispanic ethnicity, 71.4% were women, and 65.0% had annual incomes of less than $25,000. Most (90.2% had ever used CAM for arthritis, and 69.2% were using CAM at the time of the interview. Current use was highest for oral supplements (mainly glucosamine and chondroitin (34.1%, mind-body therapies (29.0%, and herbal topical ointments (25.1%. Fewer participants made current use of vitamins and minerals (16.6%, herbs taken orally (13.6%, a CAM therapist (12.7%, CAM movement therapies (10.6%, special diets (10.1%, or copper jewelry or magnets (9.2%. Those with fibromyalgia currently used an average of 3.9 CAM therapies versus 2.4 for those with rheumatoid arthritis and 2.1 for those with osteoarthritis. Current CAM use was significantly associated with being female, being under 55 years of age, and having some college education. Conclusion Hispanic and non-Hispanic white arthritis patients used CAM to supplement conventional treatments. Health care providers should be aware of the high use of CAM and incorporate questions about its use into routine assessments and treatment planning.

  10. Analysis of regulatory-ethical framework of clinical trials

    OpenAIRE

    Milošević-Georgiev Andrijana; Krajnović Dušanka; Milovanović Srđan; Ignjatović Svetlana; Đurić Dušan; Marinković Valentina

    2013-01-01

    Introduction. Every clinical trial has to meet all ethical criteria in addition to the scientific ones. The basic ethical principles in the clinical trials are the following: nonmaleficence, beneficence, respect for autonomy and the principle of justice. Objective. The aim of the study was to analyze clinical cases with the outcomes leading to the changes in regulatory­ethical framework related to the clinical trials, as well as the outcomes of key clinical trials that influenced the in...

  11. Menaquinone-7 as a novel pharmacological therapy in the treatment of rheumatoid arthritis: A clinical study.

    Science.gov (United States)

    Abdel-Rahman, Mahran S; Alkady, Eman A M; Ahmed, Sameh

    2015-08-15

    Menaquinones (MKs) have been reported to induce apoptosis in rheumatoid arthritis (RA) synovial cells. Recently, menaquinone-4 (MK-4) was proven as a new potential agent for the treatment of RA. However, menaquinone-7 (MK-7) has greater bioavailability and efficacy than MK-4 after oral administration. Yet, the therapeutic benefits of MK-7 in the management of patients with RA have never been addressed. This study was designed to clarify the therapeutic role of MK-7 added to normal therapeutic regimen of RA in patients with different stages of the disease with a clinical follow up through a randomized clinical trial. In a cross sectional study, 84 RA patients (24 male, 60 female) (average age=47.2 years) were enrolled in this study. The patients were divided into MK-7 treated group (n=42) and MK-7 naïve group (n=42). MK-7 capsules were administered in a dose of 100µg/day for three months in the first group without changing in other medications. The clinical and biochemical markers on RA patients treated with MK-7 and naïve group were assessed. In MK-7 treated group, serum concentrations of MK-7 were monitored before and after three months of MK-7 administration. In the cross sectional study, a significant decrease in MK-7 treated group for the levels of undercarboxylated osteocalcin (ucOC), erythrocyte sedimentation rate (ESR), disease activity score assessing 28 joints with ESR (DAS28-ESR), C-reactive protein (CRP) and matrix metalloproteinase (MMP-3) was found. In MK-7 treated group, a marked decrease in RA clinical and biochemical markers for moderate and good response compared to non-responders was observed in ucOC, ESR and DAS28-ESR. A marked increase in the levels of MK-7 for the moderate and good responders compared to non-responders was observed. The results suggest that MK-7 improves disease activity in RA patients. Therefore, MK-7 represents a new promising agent for RA in combination therapy with other disease modifying antirheumatic drugs.

  12. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian;

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  13. Eosinophilia predicts poor clinical outcomes in recent-onset arthritis: results from the ESPOIR cohort

    Science.gov (United States)

    Guellec, Dewi; Milin, Morgane; Cornec, Divi; Tobon, Gabriel J; Marhadour, Thierry; Jousse-Joulin, Sandrine; Chiocchia, Gilles; Vittecocq, Olivier; Devauchelle-Pensec, Valérie; Saraux, Alain

    2015-01-01

    Objectives To determine the prevalence of eosinophilia in patients with recent-onset arthritis suggestive of rheumatoid arthritis (RA) and to describe their features and outcomes. Methods We performed an ancillary study of data from a French prospective multicentre cohort study monitoring clinical, laboratory and radiographic data in patients with inflammatory arthritis of 6 weeks to 6 months duration. We determined the proportion of patients with eosinophilia, defined as a count >500/mm3, at baseline and after 3 years. Features of patients with and without baseline eosinophilia were compared. Results Baseline eosinophilia was evidenced in 26 of 804 (3.2%) patients; their mean eosinophil count was 637.7±107/mm3. Baseline eosinophilia was ascribed to atopic syndrome in 6 of 26 (23.1%) patients. After 3 years, patients with eosinophilia had higher Health Assessment Questionnaire scores (0.9 vs 0.5, p=0.004), higher patient visual analogue scale activity score and morning stiffness intensity (p=0.05), and were more often taking disease-modifying antirheumatic drugs (p=0.02). Baseline eosinophilia was not associated with presence of extra-articular manifestations. Conclusions Eosinophilia is rare in recent-onset arthritis suggestive of RA, and is usually directly related to the rheumatic disease. Our data suggest that patients with mild eosinophilia at diagnosis could respond worse to the treatment than those without. PMID:26509068

  14. Rheumatoid arthritis associated pulmonary hypertension: Clinical challenges reflecting the diversity of pathophysiology

    Directory of Open Access Journals (Sweden)

    Evangelia Panagiotidou

    2017-01-01

    Full Text Available The present article reports three clinical cases in order to elucidate the diversity of the pathophysiological mechanisms that underlie rheumatoid arthritis associated pulmonary hypertension. The condition's three major causes are: interstitial lung disease, vasculitis, and chronic thromboembolic disease, but it should be noted that the multiple pulmonary manifestations of rheumatoid arthritis, can all contribute to chronic lung disease or hypoxia. The first patient in this report suffered from moderate restriction due to fibrosis and was diagnosed with pulmonary hypertension during an episode of life threatening hypoxia. Early upfront combination therapy prevented intubation and reversed hypoxia to adequate levels. The second presented patient was a case of isolated pulmonary hypertension attributable to vasculopathy. The patient maintained normal lung volumes but low diffusion capacity and echocardiography dictated the need for right heart catheterization. Finally, the third patient presented severe functional limitation due to several manifestations of rheumatoid arthritis, but a past episode of acute pulmonary embolism was also reported although it had never been evaluated. Chronic thromboembolic disease was eventually proved to be one major cause of the patient's pulmonary hypertension. The importance of early identification of pulmonary hypertension in patients with rheumatoid arthritis is therefore emphasized, especially since multiple treatment options are available, symptoms can be treated, and right heart failure can be avoided.

  15. Rheumatoid arthritis associated pulmonary hypertension: Clinical challenges reflecting the diversity of pathophysiology.

    Science.gov (United States)

    Panagiotidou, Evangelia; Sourla, Evdokia; Kotoulas, Serafim Xrisovalantis; Akritidou, Sofia; Bikos, Vasileios; Bagalas, Vasileios; Stanopoulos, Ioannis; Pitsiou, Georgia

    2017-01-01

    The present article reports three clinical cases in order to elucidate the diversity of the pathophysiological mechanisms that underlie rheumatoid arthritis associated pulmonary hypertension. The condition's three major causes are: interstitial lung disease, vasculitis, and chronic thromboembolic disease, but it should be noted that the multiple pulmonary manifestations of rheumatoid arthritis, can all contribute to chronic lung disease or hypoxia. The first patient in this report suffered from moderate restriction due to fibrosis and was diagnosed with pulmonary hypertension during an episode of life threatening hypoxia. Early upfront combination therapy prevented intubation and reversed hypoxia to adequate levels. The second presented patient was a case of isolated pulmonary hypertension attributable to vasculopathy. The patient maintained normal lung volumes but low diffusion capacity and echocardiography dictated the need for right heart catheterization. Finally, the third patient presented severe functional limitation due to several manifestations of rheumatoid arthritis, but a past episode of acute pulmonary embolism was also reported although it had never been evaluated. Chronic thromboembolic disease was eventually proved to be one major cause of the patient's pulmonary hypertension. The importance of early identification of pulmonary hypertension in patients with rheumatoid arthritis is therefore emphasized, especially since multiple treatment options are available, symptoms can be treated, and right heart failure can be avoided.

  16. Randomization in substance abuse clinical trials

    Directory of Open Access Journals (Sweden)

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  17. IL-23 dependent and independent stages of experimental arthritis: no clinical effect of therapeutic IL-23p19 inhibition in collagen-induced arthritis.

    Directory of Open Access Journals (Sweden)

    Ferry Cornelissen

    Full Text Available IL-23p19 deficient mice have revealed a critical role of IL-23 in the development of experimental autoimmune diseases, such as collagen-induced arthritis (CIA. Neutralizing IL-23 after onset of CIA in rats has been shown to reduce paw volume, but the effect on synovial inflammation and the immunological autoimmune response is not clear. In this study, we examined the role of IL-23 at different stages of CIA and during T cell memory mediated flare-up arthritis with focus on changes in B cell activity and Th1/Th17 modulation. Anti-IL-23p19 antibody (anti-IL23p19 treatment, starting 15 days after the type II collagen (CII-immunization but before clinical signs of disease onset, significantly suppressed the severity of CIA. This was accompanied with significantly lower CII-specific IgG1 levels and lower IgG2a levels in the anti-IL-23p19 treated mice compared to the control group. Importantly, neutralizing IL-23 after the first signs of CIA did not ameliorate the disease. This was in contrast to arthritic mice that underwent an arthritis flare-up since a significantly lower disease score was observed in the IL-23p19 treated mice compared to the control group, accompanied by lower synovial IL-17A and IL-22 expression in the knee joints of these mice. These data show IL-23-dependent and IL-23-independent stages during autoimmune CIA. Furthermore, the memory T cell mediated flare-up arthritis is IL-23-mediated. These data suggest that specific neutralization of IL-23p19 after onset of autoimmune arthritis may not be beneficial as a therapeutic therapy for patients with rheumatoid arthritis (RA. However, T cell mediated arthritis relapses in patients with RA might be controlled by anti-IL-23p19 treatment.

  18. A comparison of ultrasound and clinical examination in the detection of flexor tenosynovitis in early arthritis

    Directory of Open Access Journals (Sweden)

    Abouqal Redouane

    2011-05-01

    Full Text Available Abstract Background Tenosynovitis is widely accepted to be common in rheumatoid arthritis (RA and postulated to be the first manifestation of RA, but its true prevalence in early disease and in particular the hand has not been firmly established. The aims of this study were first to investigate the frequency and distribution of finger flexor tenosynovitis using ultrasound in early arthritis, second to compare clinical examination with ultrasound (US using the latter as the gold standard. Methods 33 consecutive patients who had who were initially diagnosed with polyarthritis and suspected of polyarthritis and clinical suspicion of inflammatory arthritis of the hands and wrists were assessed during consecutive, routine presentations to the rheumatology outpatient clinic. We scanned a total of 165 finger tendons and subsequent comparisons were made using clinical examination. Results Flexor tenosynovitis was found in 17 patients (51.5% on ultrasound compared with 16 (48.4% of all patients on clinical examination. Most commonly damaged joint involved on US was the second finger followed by the third, fifth, and fourth. Both modalities demonstrated more pathology on the second and third metacarpophalangeal (MCP compared with the fourth and fifth MCP. A joint-by-joint comparison of US and clinical examination demonstrated that although the sensitivity, specificities and positive predictive values of clinical examination were relatively high, negative predictive value of clinical examination was low (0.23. Conclusions Our study suggest that clinical examination can be a valuable tool for detecting flexor disease in view of its high specificity and positive predictive values, but a negative clinical examination does not exclude inflammation and an US should be considered. Further work is recommended to standardize definitions and image acquisition for peritendinous inflammation for ultrasound.

  19. Privacy and confidentiality in pragmatic clinical trials.

    Science.gov (United States)

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations.

  20. Clinical trials integrity: a CRO perspective.

    Science.gov (United States)

    Beach, J E

    2001-01-01

    When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.

  1. Rhizomes of Eremostachys laciniata: Isolation and Structure Elucidation of Chemical Constituents and a Clinical Trial on Inflammatory Diseases

    Directory of Open Access Journals (Sweden)

    Abbas Delazar

    2013-08-01

    Full Text Available Purpose: The purpose of this study was the isolation and structure elucidation of chemical compounds from the rhizomes of Eremostachys laciniata (L Bunge (EL, an Iranian traditional medicinal herb with a thick root and pale purple or white flowers as well as the clinical studies on the therapeutic efficacy and safety of topical application of the EL extract in the management of some inflammatory conditions, e.g., arthritis, rheumatoid arthritis and septic arthritis (Riter’s syndrome. Methods: The structures of the isolated compounds were elucidated unequivocally on the basis of one and two dimensional NMR, UV and HR-FABMS spectroscopic data analyses. A single-blinded randomized clinical trial was carried out with the extract of the rhizomes of E. laciniata (EL to determine the efficacy and safety of the traditional uses of EL compared to that of piroxicam in treatment of inflammatory diseases, e.g., osteoarthritis, rheumatoid arthritis and Reiter’s syndrome. Results: Eleven iridoid glycosides, two phenylethanoids and two phytosterols were isolated and identified for the first time from the rhizomes of EL. After 14 days of treatment with the EL and piroxicam ointments, all groups showed significant improvements compared to the control groups. EL (5% ointment induced better initial therapeutic response than piroxicam (5% onitment. Conclusion: This clinical trial established that EL was suitable for topical applications as a safe and effective complementary therapy for inflammatory diseases.

  2. Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFα therapy medication

    Directory of Open Access Journals (Sweden)

    Veale Douglas J

    2011-01-01

    Full Text Available Abstract Background Substantial progress has been made in the medical management of rheumatoid arthritis (RA over the past decade with the introduction of biologic therapies, including anti-tumour necrosis factor alpha (anti-TNFα therapy medications. However, individuals with RA taking anti-TNFα medication continue to experience physical, psychological and functional consequences, which could potentially benefit from rehabilitation. There is evidence that therapeutic exercise should be included as an intervention for people with RA, but to date there is little evidence of the benefits of therapeutic exercise for people with RA on anti-TNFα therapy medication. A protocol for a multicentre randomised controlled three-armed study which aims to examine the effect of dynamic group exercise therapy on land or in water for people with RA taking anti-TNFα therapy medication is described. Methods/Design Six hundred and eighteen individuals with RA, on anti-TNFα therapy medication, will be randomised into one of 3 groups: a land-based exercise group; a water-based exercise group or a control group. The land and water-based groups will exercise for one hour, twice a week for eight weeks. The control group will receive no intervention and will be asked not to alter their exercise habits for the duration of the study. The primary outcome measure, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI which measures functional ability, and secondary measures of pain, fatigue and quality of life, will be assessed at baseline, eight and 24 weeks by an independent assessor unaware of group allocation. Changes in outcome from 0 to 8 weeks and 0 to 24 weeks in the 'land-based exercise group versus control group' and the 'water-based exercise group versus control group' will be examined. Analysis will be conducted on an intention to treat basis. Discussion This trial will evaluate the effectiveness of group exercise therapy on land or in water

  3. Therapeutic roles of curcumin: lessons learned from clinical trials.

    Science.gov (United States)

    Gupta, Subash C; Patchva, Sridevi; Aggarwal, Bharat B

    2013-01-01

    Extensive research over the past half century has shown that curcumin (diferuloylmethane), a component of the golden spice turmeric (Curcuma longa), can modulate multiple cell signaling pathways. Extensive clinical trials over the past quarter century have addressed the pharmacokinetics, safety, and efficacy of this nutraceutical against numerous diseases in humans. Some promising effects have been observed in patients with various pro-inflammatory diseases including cancer, cardiovascular disease, arthritis, uveitis, ulcerative proctitis, Crohn's disease, ulcerative colitis, irritable bowel disease, tropical pancreatitis, peptic ulcer, gastric ulcer, idiopathic orbital inflammatory pseudotumor, oral lichen planus, gastric inflammation, vitiligo, psoriasis, acute coronary syndrome, atherosclerosis, diabetes, diabetic nephropathy, diabetic microangiopathy, lupus nephritis, renal conditions, acquired immunodeficiency syndrome, β-thalassemia, biliary dyskinesia, Dejerine-Sottas disease, cholecystitis, and chronic bacterial prostatitis. Curcumin has also shown protection against hepatic conditions, chronic arsenic exposure, and alcohol intoxication. Dose-escalating studies have indicated the safety of curcumin at doses as high as 12 g/day over 3 months. Curcumin's pleiotropic activities emanate from its ability to modulate numerous signaling molecules such as pro-inflammatory cytokines, apoptotic proteins, NF-κB, cyclooxygenase-2, 5-LOX, STAT3, C-reactive protein, prostaglandin E(2), prostate-specific antigen, adhesion molecules, phosphorylase kinase, transforming growth factor-β, triglyceride, ET-1, creatinine, HO-1, AST, and ALT in human participants. In clinical trials, curcumin has been used either alone or in combination with other agents. Various formulations of curcumin, including nanoparticles, liposomal encapsulation, emulsions, capsules, tablets, and powder, have been examined. In this review, we discuss in detail the various human diseases in which the

  4. Impact of tumour necrosis factor inhibitor treatment on radiographic progression in rheumatoid arthritis patients in clinical practice

    DEFF Research Database (Denmark)

    Ornbjerg, Lykke Midtbøll; Østergaard, Mikkel; Bøyesen, Pernille;

    2013-01-01

    To compare radiographic progression during treatment with disease-modifying antirheumatic drugs (DMARD) and subsequent treatment with tumour necrosis factor α inhibitors (TNF-I) in rheumatoid arthritis (RA) patients in clinical practice.......To compare radiographic progression during treatment with disease-modifying antirheumatic drugs (DMARD) and subsequent treatment with tumour necrosis factor α inhibitors (TNF-I) in rheumatoid arthritis (RA) patients in clinical practice....

  5. Impact of tofacitinib on patient outcomes in rheumatoid arthritis – review of clinical studies

    Directory of Open Access Journals (Sweden)

    Boyce EG

    2016-01-01

    Full Text Available Eric G Boyce, Deepti Vyas, Edward L Rogan, Cynthia S Valle-Oseguera, Kate M O'Dell Department of Pharmacy Practice, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USAAbstract: Rheumatoid arthritis is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's quality of life and function. Tofacitinib was approved for the treatment of rheumatoid arthritis in the USA in 2012 and subsequently in other countries, but not by the European Medicines Agency. The goal of this review was to evaluate the impact of tofacitinib on patient-reported and patient-specific outcomes from prior clinical studies, focusing on quality of life, functionality, pain, global disease assessment, major adverse consequences, and withdrawals. A total of 13 reports representing 11 clinical studies on tofacitinib in rheumatoid arthritis were identified through PubMed and reference lists in meta-analyses and other reviews. Data on improvements in patient-driven composite tools to measure disease activity in rheumatoid arthritis, such as the Health Assessment Questionnaire, served as a major outcome evaluated in this review and were extracted from each study. Additional data extracted from those clinical studies included patient assessment of pain (using a 0–100 mm visual analog scale, patient global assessment of disease (using a 0–100 mm visual analog scale, patient withdrawals, withdrawals due to adverse effects or lack of effect, and risk of serious adverse effects, serious infections, and deaths. Tofacitinib 5 mg bid appears to have a favorable impact on patient outcomes related to efficacy and safety when compared with baseline values and with comparator disease-modifying antirheumatic drugs and placebo. Improvements were seen in the composite and individual measures of disease activity. Serious adverse effects, other

  6. Registration of clinical trials: Is it really needed?

    Directory of Open Access Journals (Sweden)

    Ameer Aslam

    2013-01-01

    Full Text Available Background and Aims: Withholding findings of clinical trials for publication or presentation to the regulatory authorities is a major concern. We aimed to address the importance of clinical trial registration and whether it is needed or not. Discussion: For ethical conduct of clinical trial, registration is an important but debatable issue due to proprietary interest of the pharmaceutical industry. Over the years, investigating agencies uncovered several instances of misconduct during the clinical trial. The International committee of medical journal editors requires registration of trial methodology, but does not require registration of trial results; however, the U.S. Food and Drug Administration Amendments does require researchers to register results. Conclusion: Prospective registration of clinical trial is mandatory for more transparent research and sustaining the validity of evidence based practice and availability of reliable data. Clinical trials registration has the potential to contribute substantially to improve clinical trial transparency and reducing publication bias and selective reporting.

  7. Assessment of enthesitis in patients with psoriatic arthritis using clinical examination and ultrasound

    Science.gov (United States)

    Kristensen, Salome; Christensen, Jeppe Hagstrup; Schmidt, Erik Berg; Olesen, Jens Lykkegaard; Johansen, Martin Berg; Arvesen, Kristian Bakke; Schlemmer, Annette

    2016-01-01

    Summary Background Enthesitis is a major feature of psoriatic arthritis. However, clinical assessment of enthesitis is known to lack accuracy and have poor interobserver reliability. Objective To determine effect of training on clinical assessment of enthesitis and to compare ultrasonography with clinical examination for the detection of entheseal abnormalities. Methods 20 rheumatologists performed repeated assessment of enthesitis in patients with established psoriatic arthritis before and after a 2-hour training session in standardised enthesitis count according to Leeds Enthesitis Index (LEI) and Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC). Moreover, 20 patients underwent clinical and ultrasonographic examination of entheses to evaluate consensus-based elementary lesions of enthesitis. Results Training significantly increased Intra-class Correlation Coefficient for LEI from 0.18 to 0.82 and for SPARCC from 0.38 to 0.67. Ultrasound examination showed high associations between hypoechogenicity and increased thickness of the entheses and clinical examination. There was no correlation between erosions and enthesophytes found by ultrasound and clinical assessments. Conclusion Training in standardised enthesitis scoring systems significantly improved clinical assessments of enthesitis and should be performed before use in daily clinical practice. Ultrasound revealed more advanced stages of enthesitis, such as enthesophytes and erosions, which were not detected with clinical examination. PMID:27900299

  8. Medical ozone increases methotrexate clinical response and improves cellular redox balance in patients with rheumatoid arthritis.

    Science.gov (United States)

    León Fernández, Olga Sonia; Viebahn-Haensler, Renate; Cabreja, Gilberto López; Espinosa, Irainis Serrano; Matos, Yanet Hernández; Roche, Liván Delgado; Santos, Beatriz Tamargo; Oru, Gabriel Takon; Polo Vega, Juan Carlos

    2016-10-15

    Medical ozone reduced inflammation, IL-1β, TNF-α mRNA levels and oxidative stress in PG/PS-induced arthritis in rats. The aim of this study was to investigate the medical ozone effects in patients with rheumatoid arthritis treated with methotrexate and methotrexate+ozone, and to compare between them. A randomized clinical study with 60 patients was performed, who were divided into two groups: one (n=30) treated with methotrexate (MTX), folic acid and Ibuprophen (MTX group) and the second group (n=30) received the same as the MTX group+medical ozone by rectal insufflation of the gas (MTX+ozone group). The clinical response of the patients was evaluated by comparing Disease Activity Score 28 (DAS28), Health Assessment Questionnaire Disability Index (HAQ-DI), Anti-Cyclic Citrullinated (Anti-CCP) levels, reactants of acute phase and biochemical markers of oxidative stress before and after 20 days of treatment. MTX+ozone reduced the activity of the disease while MTX merely showed a tendency to decrease the variables. Reactants of acute phase displayed a similar picture. MTX+ozone reduced Anti-CCP levels as well as increased antioxidant system, and decreased oxidative damage whereas MTX did not change. Glutathione correlated with all clinical variables just after MTX+ozone. MTX+ozone increased the MTX clinical response in patients with rheumatoid arthritis. No side effects were observed. These results suggest that ozone can increase the efficacy of MTX probably because both share common therapeutic targets. Medical ozone treatment is capable of being a complementary therapy in the treatment of rheumatoid arthritis.

  9. How do researchers decide early clinical trials?

    Science.gov (United States)

    Grankvist, Hannah; Kimmelman, Jonathan

    2016-06-01

    Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We then review what is currently understood about how research teams exercise this discretion, and close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research.

  10. A Randomized, Controlled, Single-Blind Trial of Leflunomide in the Treatment of Rheumatoid Arthritis

    Institute of Scientific and Technical Information of China (English)

    胡永红; 涂胜豪; 刘沛霖

    2001-01-01

    The efficacy and safety of leflunomide (LEF) in the treatment of rheumatoid arthritis (RA) were evaluated and the comparison with methotrexate's (MTX's) was performed in a 12-week, single-blind, randomized, parallel trial for treating 81 patients with RA. There were 56 cases in LEF group and 25 cases in MTX group. The dose of LEF was 20 mg per day and MTX 15 mg per week. All patients took oxaproxin simultaneously at the 4th to 6th week after the trail. The results showed that the general effective rate and notable effective rate were 94.64 % and 73.21 % in LEF group, 72 % and 44 % in MTX group, respectively, with the differences being statistically significant between the two groups (P<0.05). LEF and oxaprozin could obviously improve the symptoms, signs and joint functions. The incidence of side reactions was lower in LEF group (17.86 %) than in MTX group (40.00 %, P<0.05). LEF had a good therapeutic effect for RA, especially for refractory RA and had slight side reactions, and could be regarded as a superior immunosuppressive agent used in the treatment of RA and other connective tissue diseases.

  11. FDA Encourages More Participation, Diversity in Clinical Trials

    Science.gov (United States)

    ... Consumer Updates FDA Encourages More Participation, Diversity in Clinical Trials Share Tweet Linkedin Pin it More sharing options ... while research is conducted. back to top Do clinical trials have possible risks and benefits? Yes. Sometimes patients ...

  12. ClinicalTrials.gov | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... this page please turn Javascript on. Clinical Trials.gov Past Issues / Summer 2011 Table of Contents “...a ... help with a clinical trial: Visit www.clinicaltrials.gov Brought to you by the National Library of ...

  13. Physical function continues to improve when clinical remission is sustained in rheumatoid arthritis patients.

    Science.gov (United States)

    Radner, Helga; Alasti, Farideh; Smolen, Josef S; Aletaha, Daniel

    2015-08-11

    To investigate the course of functional status assessed by health assessment questionnaire (HAQ) in rheumatoid arthritis (RA) patients with sustained clinical remission (REM). In recent RA clinical trials, we identified patients with subsequent visits of ≥24 weeks in clinical REM according to the disease activity score using 28-joint counts including C-reactive protein (DAS28) (≤2.6), or simplified disease activity index (SDAI) (≤3.3). Area under the curve (AUC) and mean HAQ scores throughout the time in sustained REM were compared using t test, analyses of variance (ANOVA) and adjusted general linear modeling (GLM) with repeated measures. In Cox regression analyses, the time to regain full physical function was modeled. Sensitivity analyses were performed in patients of sustained SDAI low disease activity (LDA; SDAI ≤11). A total of 610 out of 4364 patients achieved sustained DAS28 REM (14%) and 252 SDAI REM (5.8%). ANOVA testing for linear trend showed significant decrease of mean HAQ from week 0 (start of REM) to week 24, regardless of REM criteria used. AUC of HAQ throughout 24 weeks of REM was higher in DAS28 compared to SDAI REM (p ≤0.01). GLM adjusting for covariates showed significant decrease of monthly HAQ scores from week 0 to 24 (DAS28: 0.276, 0.243, 0.229, 0.222, 0.219, 0.209 to 0.199; p = 0.0001; SDAI: 0.147, 0.142, 0.149, 0.129, 0.123, 0.117 to 0.114; p = 0.029). Similarly, a decrease of HAQ over time was found in patients of sustained SDAI LDA. In DAS28 REM, the chance of regaining full physical function was higher for female (hazard ratio HR [95% confidence interval]: 1.41 [1.13-1.76]) and early RA patients (disease duration ≤2 years: HR 1.29 [1.01-1.65]); in SDAI REM no significant differences were found. Physical function continues to improve if the target of REM or LDA is sustained. The stringency of the remission criteria determines achievement of the best possible functional improvement.

  14. AUTOANTIBODIES TO CIRTULLINATED ANTIGENS FOR DIAGNOSIS AND PREDICTION OF CLINICAL COURSE IN EARLY RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    I. B. Belyaeva

    2007-01-01

    , both RF- and anti-CCP seropositivity represent sufficient risk factors for erosive arthritis within a year after clinical manifestations.

  15. Differences Between Clinical Trials of Medical Devices and Drugs

    Institute of Scientific and Technical Information of China (English)

    ZHANG Zhi-jun; LIU Wei

    2014-01-01

    How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of defi-nition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conduct-ing clinical trial design for medical devices.

  16. Prevalence and clinical patterns of psoriatic arthritis in Indian patients with psoriasis

    Directory of Open Access Journals (Sweden)

    Ramesh Kumar

    2014-01-01

    Full Text Available Background: The prevalence and clinical patterns of psoriatic arthritis (PsA varies in different parts of the world and there is little clinical and epidemiological data from the Indian subcontinent. Aims: Our study was designed to evaluate the prevalence and clinical patterns of PsA in Indian patients. Methods: This was a non-interventional, cross-sectional study, in which 1149 consecutive psoriasis patients seen over 1 year were screened for PsA according to classification of psoriatic arthritis (CASPAR criteria. Demographic and disease parameters were recorded including Psoriasis Area and Severity Index (PASI, Nail Psoriasis Severity Index (NAPSI, and number of swollen and tender joints. Results: Among 1149 patients with psoriasis, 100 (8.7% patients had PsA, of which 83% were newly diagnosed. The most common pattern was symmetrical polyarthritis (58%, followed by spondyloarthropathy 49%, asymmetric oligoarthritis (21%, isolated spondyloarthropathy (5%, predominant distal interphalangeal arthritis (3%, and arthritis mutilans (1%. Enthesitis and dactylitis were present in 67% and 26% of cases, respectively. The mean number of swollen and tender joints were 3.63 ± 3.59 (range, 0-22 and 7.76 ± 6.03 (range, 1-26, respectively. Nail changes were present in 87% of the cases. The median PASI and NAPSI of the subjects with PsA was 3.6 and 20, respectively. There was no significant correlation of number of swollen/tender joints with PASI or NAPSI. Conclusion: There is a relatively low prevalence of PsA among Indian psoriasis patients presenting to dermatologists. No correlation was found between the severity of skin and nail involvement and articular disease.

  17. Innovative medicines for treatment of psoriatic arthritis

    Directory of Open Access Journals (Sweden)

    Levitan A.l.

    2015-09-01

    Full Text Available The problem of effective treatment of psoriatic arthritis has not been solved yet. The search for new therapeutic options is very active in many directions. At the stage of clinical trials are drugs that block interleukin-17-a (secukinumab, ixekizumab, brodalumab, drugs that suppress interleukin-12 and interleukin-23 (ustekinumab. To modern means to ensure psoriatic arthritis include drugs that are inhibitors of small molecules orkinase pathways (apremilast, tofacitinib.

  18. To fail or not to fail : clinical trials in depression

    NARCIS (Netherlands)

    Santen, Gijs Willem Eduard

    2008-01-01

    To fail or not to fail – Clinical trials in depression investigates the causes of the high failure rate of clinical trials in depression research. Apart from the difficulties in the search for new antidepressants during drug discovery, faulty clinical trial designs hinder their evaluation during dru

  19. Psoriatic Arthritis in Psoriasis Patients: Evaluation of Clinical and Radiological Features

    Directory of Open Access Journals (Sweden)

    Hatice Reşorlu

    2016-08-01

    Full Text Available Objective: The purpose of this study was to perform radiological and clinical determination of the presence of psoriatic arthritis (PsA in patients with psoriasis and to evaluate associations with clinical findings. Materials and Methods: The medical files of 72 patients with psoriasis presenting to our clinic between years 2009-2014 with a pre-diagnosis of PsA were reviewed retrospectively. Hand, foot and sacroiliac joint radiograms were evaluated by a radiologist who was blinded to the patient’s clinical status and who is experienced on musculoskeletal radiology. Patients with psoriasis were divided into two groups according to the presence of arthritis which was determined based on radiographic findings or on Classification Criteria for Psoriatic Arthritis (CASPAR criteria. All patients’ demographic characteristics, length of disease, nail involvement, smoking-alcohol consumption were recorded. Results: The mean age of all patients was 47.24±14.61 years, and the mean duration of disease was 14.13±11.92 years. Smoking and alcohol consumptions were determined in 54.2% (n=39 and 23.6% (n=17 of the cases, respectively. Nail involvement was determined in 56.9% (n=41 of the cases. PsA was determined based on radiological findings in 58.3% (n=42 of the patients. The mean age and age at onset of disease were higher in PsA (+ patients than in radiologically non-PsA subjects. Based on clinical findings, PsA based on CASPAR criteria was determined in only 18.1% (n=13 of all patients. Conclusion: A higher level of PsA was determined using radiological evaluation in this study. The main cause of this condition is the existence of asymptomatic-subclinical patients. A detailed medical history should therefore be taken from patients, and good clinical evaluation is very important. Radiological and clinical evaluation should be performed together in the diagnosis.

  20. [Ethical aspects of randomized clinical trials].

    Science.gov (United States)

    Bartoli, E; Sorrentino, D; Trevisi, A

    1997-01-01

    Randomized clinical trials represent the final, essential link between basic medical research and human health. However, their conduction presents very complex ethical problems, since the patient is the actual target of the experiment. Proper randomization, informed consent, and preliminary disclosure of results create deep ethical conflicts between the role of caretaker and that of impartial observer, both played by the same doctor. The dilemma reproduces the conflict between two different ethics. One is based on the inalienable individual rights stemming from the concept of man as an end in himself and not a means to an end. The other, derived from utilitarian philosophies, is based on the benefit for society as a whole. If we agree that randomized clinical trials represent the best method to test the validity of a new treatment, there is no easy solution. The dilemma could be solved by separating the role of the family doctor, committed to the best treatment possible for his patient, from the role of the scientist, committed to the progress of science and humanity. The former is involved in the treatment of individual patients, the latter in clinical and scientific experiments of a therapeutic nature. The patient may trade his rights to the best possible cure for the safety and the efficiency guaranteed by the scientific institution conducting the trial. Trials on relevant issues--expected to produce important results and impeccably designed scientifically--could be endowed with the ethics of science per se and this could be considered equivalent to the individual rights waived by the patient.

  1. Correlation analyses of clinical and molecular findings identify candidate biological pathways in systemic juvenile idiopathic arthritis

    Directory of Open Access Journals (Sweden)

    Ling Xuefeng B

    2012-10-01

    Full Text Available Abstract Background Clinicians have long appreciated the distinct phenotype of systemic juvenile idiopathic arthritis (SJIA compared to polyarticular juvenile idiopathic arthritis (POLY. We hypothesized that gene expression profiles of peripheral blood mononuclear cells (PBMC from children with each disease would reveal distinct biological pathways when analyzed for significant associations with elevations in two markers of JIA activity, erythrocyte sedimentation rate (ESR and number of affected joints (joint count, JC. Methods PBMC RNA from SJIA and POLY patients was profiled by kinetic PCR to analyze expression of 181 genes, selected for relevance to immune response pathways. Pearson correlation and Student's t-test analyses were performed to identify transcripts significantly associated with clinical parameters (ESR and JC in SJIA or POLY samples. These transcripts were used to find related biological pathways. Results Combining Pearson and t-test analyses, we found 91 ESR-related and 92 JC-related genes in SJIA. For POLY, 20 ESR-related and 0 JC-related genes were found. Using Ingenuity Systems Pathways Analysis, we identified SJIA ESR-related and JC-related pathways. The two sets of pathways are strongly correlated. In contrast, there is a weaker correlation between SJIA and POLY ESR-related pathways. Notably, distinct biological processes were found to correlate with JC in samples from the earlier systemic plus arthritic phase (SAF of SJIA compared to samples from the later arthritis-predominant phase (AF. Within the SJIA SAF group, IL-10 expression was related to JC, whereas lack of IL-4 appeared to characterize the chronic arthritis (AF subgroup. Conclusions The strong correlation between pathways implicated in elevations of both ESR and JC in SJIA argues that the systemic and arthritic components of the disease are related mechanistically. Inflammatory pathways in SJIA are distinct from those in POLY course JIA, consistent with

  2. Clinical Trials and Treatment of ATL

    Directory of Open Access Journals (Sweden)

    Kunihiro Tsukasaki

    2012-01-01

    Full Text Available ATL is a distinct peripheral T-lymphocytic malignancy associated with human T-cell lymphotropic virus type I (HTLV-1. The diversity in clinical features and prognosis of patients with this disease has led to its subtype-classification into four categories, acute, lymphoma, chronic, and smoldering types, defined by organ involvement, and LDH and calcium values. In case of acute, lymphoma, or unfavorable chronic subtypes (aggressive ATL, intensive chemotherapy like the LSG15 regimen (VCAP-AMP-VECP is usually recommended if outside of clinical trials, based on the results of a phase 3 trial. In case of favorable chronic or smoldering ATL (indolent ATL, watchful waiting until disease progression has been recommended, although the long-term prognosis was inferior to those of, for instance, chronic lymphoid leukemia. Retrospective analysis suggested that the combination of interferon alpha and zidovudine was apparently promising for the treatment of ATL, especially for types with leukemic manifestation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT is also promising for the treatment of aggressive ATL possibly reflecting graft versus ATL effect. Several new agent trials for ATL are ongoing and in preparation, including a defucosylated humanized anti-CC chemokine receptor 4 monoclonal antibody, IL2-fused with diphtheria toxin, histone deacetylase inhibitors, a purine nucleoside phosphorylase inhibitor, a proteasome inhibitor, and lenalidomide.

  3. A matched crossover design for clinical trials.

    Science.gov (United States)

    Simon, Laura J; Chinchilli, Vernon M

    2007-09-01

    Two design principles are used frequently in clinical trials: 1) A subject is "matched" or "paired" with a similar subject to reduce the chance that other variables obscure the primary comparison of interest. 2) A subject serves as his/her own control by "crossing over" from one treatment to another during the course of an experiment. There are situations in which it may be advantageous to use the two design principles - crossing over and matching - simultaneously. That is, it may be advantageous to conduct a "paired crossover design," in which each subject, while paired with a similar subject, crosses over and receives each experimental treatment. In this paper, we describe two clinical trials conducted by the National Heart, Lung and Blood Institute's Asthma Clinical Research Network that used a paired 2x2 crossover design. The Beta Adrenergic Response by GEnotype (BARGE) Study compared the effects of regular use of inhaled albuterol on mildly asthmatic patients with different genotypes at the 16th position of the beta-agonist receptor gene. The Smoking Modulates Outcomes of Glucocorticoid (SMOG) Therapy in Asthma Study evaluated the hypothesis that smoking reduces the response to inhaled corticosteroids. For such paired crossover designs, the primary parameter of interest is typically the treatment-by-pairing interaction term. In evaluating the relative efficiency of the paired 2x2 crossover design to two independent crossover designs with respect to this interaction term, we show that the paired 2x2 crossover design is more efficient if the correlations between the paired members on the same treatments are greater than their correlations on different treatments. This condition should hold in most circumstances, and therefore the paired crossover design deserves serious consideration for any clinical trial in which the crossing over and matching of subjects is deemed simultaneously beneficial.

  4. Clinical trials in Ayurveda: Analysis of clinical trial registry of India.

    Science.gov (United States)

    Sridharan, Kannan; Sivaramakrishnan, Gowri

    Ayurveda is one of the complementary and alternative systems of medicine requiring generation of high quality evidence for rational practice. Evidence can be generated from study designs and the present study is an attempt to critically assess the registered studies in the field of Ayurveda from clinical trial registry of India. We found low number of trials conducted with more focus required on the quality of these studies to contribute to high quality evidence.

  5. Utility of the new rheumatoid arthritis 2010 ACR/EULAR classification criteria in routine clinical care

    Science.gov (United States)

    Kennish, Lauren; Labitigan, Monalyn; Budoff, Sam; Filopoulos, Maria T; McCracken, W Andrew; Swearingen, Christopher J; Yazici, Yusuf

    2012-01-01

    Objectives The new 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria for rheumatoid arthritis (RA) have been designed to classify early onset RA, but has not been studied to identify RA in patients with arthritis seen in routine clinical care where correct ‘classification’ of patients, when they are not selected for having RA would be important. Design Prospective, consecutive patients cohort. Setting Outpatient clinic of a university rheumatology centre. Participants A total of 126 patients with joint symptoms were consecutively recruited. Interventions The ACR/EULAR RA criteria were applied, with questions followed by a targeted musculoskeletal exam. The gold standard for the diagnosis of RA was the primary rheumatologist's diagnosis. Primary outcome measure Number of patients with non-RA diagnosis who were classified as having RA by the new classification criteria. Results The sensitivity and specificity of the 2010 criteria in classifying RA were 97% and 55%, respectively, compared with the 1987 RA criteria which were 93% and 76%, respectively. The 2010 criteria as applied to this group of patients had a poorer positive predictive (44% vs 61%) and a similar negative predictive value (98% vs 97%) compared with the 1987 criteria. More specifically, 66.7% of systemic lupus erythematosus patients, 50% of osteoarthritis, 37.5% of psoriatic arthritis and 27.2% of others fulfilled the new criteria and could have been classified as RA. Conclusions In this, we believe, the first study to examine the new 2010 ACR/EULAR RA criteria among consecutive patients seen in routine care, we found the criteria to have low specificity, and therefore incorrectly label those as having RA when, in fact, they may have a different type of inflammatory arthritis. Physicians need to be aware of this when applying the new criteria for classifying their patients for any purpose. PMID:23035013

  6. [PDCA Applied in Special Rectification of Medical Instrument Clinical Trial].

    Science.gov (United States)

    Wang, Lei; Qu, Xintao; Yu, Xiuchun

    2015-09-01

    PDCA cycle was applied in special rectification activities for medical instrument clinical trial, with quality criteria of implementation made. Completed medical instrument clinical trial from January 2011 to December 2012 was believed as control group, from January 2013 to December 2014 as PDCA group, the scores of clinical trial and the score rate of items were compared and analyzed. Results show quality scores of clinical trial in PDCA group are higher than that in control group (51 vs. 81, P rectification activities with PDCA applied in our department are feasible and effective. It significantly improves implement quality of medical instrument clinical trial.

  7. Ottawa Panel Evidence-Based Clinical Practice Guidelines for Patient Education in the Management of Rheumatoid Arthritis (RA)

    Science.gov (United States)

    Brosseau, Lucie; Wells, George A.; Tugwell, Peter; Egan, Mary; Dubouloz, Claire-Jehanne; Welch, Vivian A.; Trafford, Laura; Sredic, Danjiel; Pohran, Kathryn; Smoljanic, Jovana; Vukosavljevic, Ivan; De Angelis, Gino; Loew, Laurianne; McEwan, Jessica; Bell, Mary; Finestone, Hillel M.; Lineker, Sydney; King, Judy; Jelly, Wilma; Casimiro, Lynn; Haines-Wangda, Angela; Russell-Doreleyers, Marion; Laferriere, Lucie; Lambert, Kim

    2012-01-01

    Background and purpose: The objective of this article is to create guidelines for education interventions in the management of patients ([greater than] 18 years old) with rheumatoid arthritis (RA). Methods: The Ottawa Methods Group identified and synthesized evidence from comparative controlled trials using Cochrane Collaboration methods. The…

  8. Ottawa Panel Evidence-Based Clinical Practice Guidelines for Patient Education in the Management of Rheumatoid Arthritis (RA)

    Science.gov (United States)

    Brosseau, Lucie; Wells, George A.; Tugwell, Peter; Egan, Mary; Dubouloz, Claire-Jehanne; Welch, Vivian A.; Trafford, Laura; Sredic, Danjiel; Pohran, Kathryn; Smoljanic, Jovana; Vukosavljevic, Ivan; De Angelis, Gino; Loew, Laurianne; McEwan, Jessica; Bell, Mary; Finestone, Hillel M.; Lineker, Sydney; King, Judy; Jelly, Wilma; Casimiro, Lynn; Haines-Wangda, Angela; Russell-Doreleyers, Marion; Laferriere, Lucie; Lambert, Kim

    2012-01-01

    Background and purpose: The objective of this article is to create guidelines for education interventions in the management of patients ([greater than] 18 years old) with rheumatoid arthritis (RA). Methods: The Ottawa Methods Group identified and synthesized evidence from comparative controlled trials using Cochrane Collaboration methods. The…

  9. Tofacitinib versus methotrexate in rheumatoid arthritis: patient-reported outcomes from the randomised phase III ORAL Start trial

    Science.gov (United States)

    Strand, Vibeke; Lee, Eun Bong; Fleischmann, Roy; Koncz, Tamas; Zwillich, Samuel H; Gruben, David; Wilkinson, Bethanie; Krishnaswami, Sriram; Wallenstein, Gene

    2016-01-01

    Objectives To compare patient-reported outcomes (PROs) in methotrexate (MTX)-naive patients (defined as no prior treatment or ≤3 doses) receiving tofacitinib versus MTX. Methods In the 24-month, phase III, randomised, controlled, ORAL Start trial (NCT01039688), patients were randomised 2:2:1 to receive tofacitinib 5 mg two times per day (n=373), tofacitinib 10 mg two times per day (n=397) or MTX (n=186). PROs assessed included Patient Global Assessment of disease (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and health-related quality of life (Short Form-36 [SF-36]). Results PROs improved following tofacitinib and MTX treatment: benefits were sustained over 24 months. Patients receiving tofacitinib reported earlier responses which were significantly different between each tofacitinib dose and MTX at month 3 through month 24. At month 6 (primary end point), significant improvements versus MTX were observed in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 5/8 domain scores and FACIT-F with tofacitinib 5 mg two times per day; all PROs, except SF-36 Mental Component Summary Score and Medical Outcomes Survey-Sleep, with tofacitinib 10 mg two times per day. At month 6, the proportion of patients reporting improvements ≥minimum clinically important difference were significant versus MTX with tofacitinib 5 mg two times per day in PtGA and 3/8 SF-36 domains; and with tofacitinib 10 mg two times per day in PtGA, pain, HAQ-DI, SF-36 PCS, 4/8 domains and FACIT-F. Conclusions Patients with rheumatoid arthritis receiving tofacitinib 5 and 10 mg two times per day monotherapy versus MTX reported statistically significant and clinically meaningful improvements in multiple PROs over 24 months; onset of benefit with tofacitinib treatment occurred earlier. Trial registration number NCT01039688.

  10. The Way Forward: Practical Clinical Considerations for the Use of Canakinumab in Patients With Difficult-to-Treat Gouty Arthritis.

    Science.gov (United States)

    Bardin, Thomas; van de Laar, Martinus A F J

    2015-10-01

    Canakinumab is indicated for patients with frequent gouty arthritis attacks who cannot be managed with standard-of-care medication, and should be used according to the labeled indication. Given its mechanism of action, physicians need to be aware of the potential contraindications and precautions with its use. When deciding as to whether a patient with gouty arthritis is an appropriate candidate for canakinumab treatment, several key clinical considerations should be kept in mind, which are discussed herein.

  11. What is the impact of ethics on clinical trials?

    Science.gov (United States)

    Spielman, Bethany

    2016-01-01

    Ethics has often been ignored or evaded in clinical trials, and the conditions under which global clinical trials are conducted make this problem likely to persist. Ethics can, however, have an impact at any of several stages of a trial when the individuals involved are committed. This editorial provides historical examples of ignoring, evading or, alternatively, using ethical help to improve clinical trials, and suggests that the actual role of ethics depends on the individuals involved.

  12. Systematic review of the methodological quality of controlled trials evaluating Chinese herbal medicine in patients with rheumatoid arthritis

    Science.gov (United States)

    Pan, Xin; Lopez-Olivo, Maria A; Song, Juhee; Pratt, Gregory; Suarez-Almazor, Maria E

    2017-01-01

    Objectives We appraised the methodological and reporting quality of randomised controlled clinical trials (RCTs) evaluating the efficacy and safety of Chinese herbal medicine (CHM) in patients with rheumatoid arthritis (RA). Design For this systematic review, electronic databases were searched from inception until June 2015. The search was limited to humans and non-case report studies, but was not limited by language, year of publication or type of publication. Two independent reviewers selected RCTs, evaluating CHM in RA (herbals and decoctions). Descriptive statistics were used to report on risk of bias and their adherence to reporting standards. Multivariable logistic regression analysis was performed to determine study characteristics associated with high or unclear risk of bias. Results Out of 2342 unique citations, we selected 119 RCTs including 18 919 patients: 10 108 patients received CHM alone and 6550 received one of 11 treatment combinations. A high risk of bias was observed across all domains: 21% had a high risk for selection bias (11% from sequence generation and 30% from allocation concealment), 85% for performance bias, 89% for detection bias, 4% for attrition bias and 40% for reporting bias. In multivariable analysis, fewer authors were associated with selection bias (allocation concealment), performance bias and attrition bias, and earlier year of publication and funding source not reported or disclosed were associated with selection bias (sequence generation). Studies published in non-English language were associated with reporting bias. Poor adherence to recommended reporting standards (<60% of the studies not providing sufficient information) was observed in 11 of the 23 sections evaluated. Limitations Study quality and data extraction were performed by one reviewer and cross-checked by a second reviewer. Translation to English was performed by one reviewer in 85% of the included studies. Conclusions Studies evaluating CHM often fail to

  13. Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial

    DEFF Research Database (Denmark)

    Herly, M; Stengaard-Pedersen, K.; Hørslev-Petersen, K.

    2017-01-01

    INTRODUCTION: Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (RA), and among these patients, the prevalence of hypovitaminosis D is high. Moreover, low vitamin D levels have been associated with increased cardiovascular risk in healthy subjects. OBJECTIVE......: To evaluate the long-term risk of cardiovascular events in patients having low total 25-hydroxyvitamin D levels at baseline compared with patients with normal levels, in an efficiently treated, closed cohort of patients with an early diagnosis of RA. METHODS AND ANALYSIS: This study is a prospective, closed......, blinded endpoint cohort study, based on secondary analyses from a previous randomised trial (CIMESTRA study; NCT00209859, approved September 1999) including 160 patients with an early diagnosis of RA from Danish University clinics. Primary outcome will be the proportion of patients with any cardiovascular...

  14. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Science.gov (United States)

    2012-08-16

    ... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial... Pharmaceutical Clinical Trial; (3) Medical Device Aspects of Clinical Research; (4) Adverse Event...

  15. Clinical and immunogenetic characteristics of psoriatic arthritis: a single-center experience from South India

    Directory of Open Access Journals (Sweden)

    CB Mithun

    2013-02-01

    Full Text Available AimThe aim of this study was to determine the clinical characteristics and prevalence of HLA B27 in patients with psoriatic arthritis presenting to a tertiary care centre in South India. BackgroundAlthough the prevalence of psoriasis is high in India, there is paucity of data, especially on Ps A. Materials and methodsThis retrospective study included 141 patients satisfying the ClASsification criteria for Ps A (CASPAR. Demographic, clinical, and laboratory data of the patients were collected through personal interviews, clinical examination, appropriate investigations, and analysis of case records. HLA-B27 typing by PCR method was done for all patients. ResultsAmong the 141 patients, 89 subjects were males and 52 were females, and the male to female ratio was 1.7:1. Polyarthritis (n=51, 36.2% was the most common Ps A subtype noted during the study, followed by oligoarthritis (n=48, 34%, spondyloarthropathy (n=29, 20.6%, distal interphalangeal (DIP predominant arthritis (n=25, 7.8%, and arthritis mutilans (n=2, 1.4%. Arthritis preceded skin involvement in 9.2% (n=13 of the cases. Dactylitis was seen in 24.1% (n=34 of the patients. Extra-articular features like enthesitis (n=16, 11.3% and eye involvement (n=1, 0.7% were also observed. Deformities were seen in 32.6% (n=46 of the subjects. The most common type of psoriatic skin lesion noted was psoriasis vulgaris (n=119, 84.4%. Nail involvement was seen in 17.7% (n=25 of the patients and it was observed in all subjects with DIP predominant arthritis (100%. Family history of psoriasis was present in 11.3% (n=16 of the patients. The number of patients positive for HLA B27 was 16 (11.3%. Additionally, the antigen positivity was noted in 35.7% (n=10 of the patients with spondyloarthropathy. ConclusionPs A was more common in males. Polyarthritis and oligoarthritis were the most prevalent subtypes. The prevalence of HLA-B27 in our study population was 11.3% and was found to be strongly associated with

  16. Impact of sonography in gouty arthritis: Comparison with conventional radiography, clinical examination, and laboratory findings

    Energy Technology Data Exchange (ETDEWEB)

    Schueller-Weidekamm, Claudia [Department of Diagnostic Radiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria)]. E-mail: claudia.schueller-weidekamm@meduniwien.ac.at; Schueller, Gerd [Department of Diagnostic Radiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria); Aringer, Martin [Department of Rheumatology, Internal Medicine III, Medical University of Vienna (Austria); Weber, Michael [Department of Diagnostic Radiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria); Kainberger, Franz [Department of Diagnostic Radiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria)

    2007-06-15

    Objective: To explore the typical sonographic features of gray-scale and Power Doppler of acute and chronic gouty arthritis in conjunction with radiographic, clinical, and laboratory findings. Materials and methods: All hand, finger, and toe joints of 19 patients with acute and chronic gout were examined with gray-scale and Power Doppler sonography. The number and size of bone changes detected with sonography was compared to radiographic findings. Vascularization of the synovial tissue was scored on Power Doppler (grades 0-3), and was compared with clinical appearance, including swelling, tenderness, and redness (grades 0-3). Results: In acute gout, mild to moderate echogenic periarticular nodules with sonotransmission and hypervascularization of the edematous surrounding soft tissue were found. In chronic gout, tophaceous nodules completely blocked transmission of US wave, leading to strong reflexion and dorsal shadowing in a minority of cases. No significant difference in the detection of large bone changes (>2 mm) was found between sonography and radiography. However, gray-scale sonography was significantly more sensitive in the detection of small bone changes (p < 0.001). Power Doppler scores were statistically significantly higher than clinical examination scores (p < 0.001). Discussion: Sonography is superior to radiographs in evaluating small bone changes. The inflammatory process in joints can be better detected with Power Doppler sonography than with clinical examination. Typical sonographic appearance of acute and in particular of chronic gout might provide clues on gouty arthritis that adds to the information available from conventional radiography, clinical, and laboratory findings.

  17. Adalimumab reduces hand bone loss in rheumatoid arthritis independent of clinical response: Subanalysis of the PREMIER study

    Directory of Open Access Journals (Sweden)

    Elden Aake

    2011-02-01

    Full Text Available Abstract Background Anti-TNF therapy has been shown to reduce radiographic joint damage in rheumatoid arthritis (RA independent of clinical response. This has previously not been examined for periarticular bone loss, the other characteristic feature of bone involvement in RA. The objective of this study was to examine if treatment with the TNF-α inhibitor adalimumab also could reduce periarticular bone loss in RA patients independent of disease activity. Methods RA patients were recruited from the PREMIER study and included 214 patients treated with methotrexate (MTX plus adalimumab and 188 patients treated with MTX monotherapy. Periarticular bone loss was assessed by digital X-ray radiogrammetry metacarpal cortical index (DXR-MCI. Change in DXR-MCI was evaluated in patients with different levels of clinical response, as assessed by changes in DAS28 score at 52 weeks and in mean C-reactive protein (CRP levels during follow-up. Results In the MTX group, there was a greater median DXR-MCI loss among patients with moderate and high disease activity compared to those in remission or with low disease activity (-3.3% vs. -2.2%, p = 0.01. In contrast, periarticular bone loss was independent of disease activity (-1.9% vs. -2.4%, p = 0.99 in the combination group. In the MTX group patients with a mean CRP of ≥ 10 mg/l lost significantly more DXR-MCI than patients with low CRP (-3.1% vs. -1.9%, p Conclusion Adalimumab in combination with MTX reduces periarticular bone loss independently of clinical response. These results support the hypothesis that TNF-α stimulates the osteoclast not only by the inflammatory pathway but do also have a direct effect on the osteoclast. Trial Registration ClinicalTrials (NCT: NCT001195663

  18. Spa therapy adjunct to pharmacotherapy is beneficial in rheumatoid arthritis: a crossover randomized controlled trial

    Science.gov (United States)

    Karagülle, Mine; Kardeş, Sinan; Dişçi, Rian; Karagülle, Müfit Zeki

    2017-09-01

    This study aims to investigate whether 2-week spa therapy, as an adjunct to usual pharmacological therapy, has any beneficial effect in patients with rheumatoid arthritis (RA). In this single-blind crossover study, 50 patients were randomly assigned in a 1:1 manner to receive usual pharmacological therapy plus 2-week spa therapy or usual pharmacological therapy alone (period 1.6 months); after a 9-month washout, patients were crossed over to the opposite assignment (period 2.6 months). Spa therapy program included a daily saline balneotherapy session at 36-37 °C for 20 min except Sundays. The clinical outcomes were evaluated at baseline, after spa therapy (2 weeks) and 3 and 6 months after the spa therapy in both period and were pain (Visual Analogue Scale (VAS)), patient and physician global assessments (VAS), Health Assessment Questionnaire (HAQ), and Disease Activity Score (DAS28). Spa therapy was superior to control therapy in improving all the assessed clinical outcomes at the end of the spa therapy. This superiority persisted significantly in physician global assessment (p = 0.010) and with a trend in favor of spa group in patient global assessment (p = 0.058), function (p = 0.092), and disease activity (p = 0.098) at 3 months. Statistically significant improvements were found in spa therapy compared to control in disease activity (p = 0.006) and patient (p = 0.020) and physician global (p = 0.011) assessments, and a trend toward improvements in pain (p = 0.069) and swollen joints (p = 0.070) at 6 months. A 2-week spa therapy adjunct to usual pharmacological therapy provided beneficial clinical effects compared to usual pharmacological therapy alone, in RA patients treated with traditional disease-modifying antirheumatic drugs. These beneficial effects may last for 6 months.

  19. TNF-α Polymorphisms in Juvenile Idiopathic Arthritis: Which Potential Clinical Implications?

    Directory of Open Access Journals (Sweden)

    A. Scardapane

    2012-01-01

    Full Text Available Whether tumor necrosis factor alpha (TNF-α gene polymorphisms (SNPs influence disease susceptibility and treatment of patients with juvenile idiopathic arthritis (JIA is presently uncertain. TNF-α is one of the most important cytokine involved in JIA pathogenesis. Several single nucleotide polymorphisms (SNPs have been identified within the region of the TNF-α gene but only a very small minority have proven functional consequences and have been associated with susceptibility to JIA. An association between some TNF-α SNPs and adult rheumatoid arthritis (RA susceptibility, severity and clinical response to anti-TNF-α treatment has been reported. The most frenquetly studied TNF-α SNP is located at −308 position, where a substitution of the G allele with the rare A allele has been found. The presence of the allele −308A is associated to JIA and to a poor prognosis. Besides, the −308G genotype has been associated with a better response to anti-TNF-α therapy in JIA patients, confirming adult data. Psoriatic and oligoarticular arthritis are significantly associated to the −238 SNP only in some works. Studies considering other SNPs are conflicting and inconclusive. Large scale studies are required to define the contribution of TNF-α gene products to disease pathogenesis and anti-TNF-α therapeutic efficacy in JIA.

  20. Use of crowdsourcing for cancer clinical trial development.

    Science.gov (United States)

    Leiter, Amanda; Sablinski, Tomasz; Diefenbach, Michael; Foster, Marc; Greenberg, Alex; Holland, John; Oh, William K; Galsky, Matthew D

    2014-10-01

    Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct.

  1. Globalization of clinical trials - where are we heading?

    Science.gov (United States)

    George, Melvin; Selvarajan, Sandhiya; S, Suresh-Kumar; Dkhar, Steven A; Chandrasekaran, Adithan

    2013-05-01

    The last decade has witnessed a greater transparency in clinical research with the advent of clinical trial registries. The aim of the study was to describe the trends in the globalization of clinical trials in the last five years. We performed an internet search using the WHO International clinical trials registry platform (WHO ICTRP) to identify the clinical trials conducted from January 2007 to December 31, 2011 among 25 countries. Among the 25 countries, the United States, Japan and Germany occupy the top positions in the total number of clinical trials conducted. Clinical trials in the US (36312) constituted 31.5% of the total number of trials performed during this period. However over a period of five years both US and Western Europe appear to show a decline, while the emerging countries show a rise in clinical trials registered. Among the emerging countries China, India and Republic of Korea are most active regions involved in clinical trials. Cancer, diabetes and respiratory diseases were most widely researched areas overall. Although the study confirms the transition in the clinical trials research towards emerging countries, the developed regions of the world still contribute to more than 70% of the trials registered worldwide.

  2. Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA: A randomised placebo-controlled crossover trial

    Directory of Open Access Journals (Sweden)

    Richmond Stewart J

    2008-09-01

    Full Text Available Abstract Background Rheumatoid arthritis is a common inflammatory autoimmune disease. Although disease activity may be managed effectively with prescription drugs, unproven treatments such as magnet therapy are sometimes used as an adjunct for pain control. Therapeutic devices incorporating permanent magnets are widely available and easy to use. Magnets may also be perceived as a more natural and less harmful alternative to analgesic compounds. Of interest to health service researchers is the possibility that magnet therapy might help to reduce the economic burden of managing chronic musculoskeletal disorders. Magnets are extremely cheap to manufacture and prolonged treatment involves a single cost. Despite this, good quality scientific evidence concerning the safety, effectiveness and cost-effectiveness of magnet therapy is scarce. The primary aim of the CAMBRA trial is to investigate the effectiveness of magnet therapy for relieving pain and inflammation in rheumatoid arthritis. Methods/Design The CAMBRA trial employs a randomised double-blind placebo-controlled crossover design. Participant will each wear four devices: a commercially available magnetic wrist strap; an attenuated wrist strap; a demagnetised wrist strap; and a copper bracelet. Device will be allocated in a randomised sequence and each worn for five weeks. The four treatment phases will be separated by wash out periods lasting one week. Both participants and researchers will be blind, as far as feasible, to the allocation of experimental and control devices. In total 69 participants will be recruited from general practices within the UK. Eligible patients will have a verified diagnosis of rheumatoid arthritis that is being managed using drugs, and will be experiencing chronic pain. Outcomes measured will include pain, inflammation, disease activity, physical function, medication use, affect, and health related costs. Data will be collected using questionnaires, diaries, manual

  3. Septic arthritis in patients with rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Al-Ahaideb Abdulaziz

    2008-07-01

    Full Text Available Abstract There is an increasing number of rheumatoid patients who get septic arthritis. Chronic use of steroids is one of the important predisposing factors. The clinical picture of septic arthritis is different in immunocompromised patients like patients with rheumatoid arthritis. The diagnosis and management are discussed in this review article.

  4. Septic arthritis in patients with rheumatoid arthritis

    OpenAIRE

    Al-Ahaideb Abdulaziz

    2008-01-01

    Abstract There is an increasing number of rheumatoid patients who get septic arthritis. Chronic use of steroids is one of the important predisposing factors. The clinical picture of septic arthritis is different in immunocompromised patients like patients with rheumatoid arthritis. The diagnosis and management are discussed in this review article.

  5. Clinical trials for stem cell transplantation: when are they needed?

    Science.gov (United States)

    Van Pham, Phuc

    2016-04-27

    In recent years, both stem cell research and the clinical application of these promising cells have increased rapidly. About 1000 clinical trials using stem cells have to date been performed globally. More importantly, more than 10 stem cell-based products have been approved in some countries. With the rapid growth of stem cell applications, some countries have used clinical trials as a tool to diminish the rate of clinical stem cell applications. However, the point at which stem cell clinical trials are essential remains unclear. This commentary discusses when stem cell clinical trials are essential for stem cell transplantation therapies.

  6. Real-time enrollment dashboard for multisite clinical trials

    Directory of Open Access Journals (Sweden)

    William A. Mattingly

    2015-10-01

    Conclusion: We have designed and implemented a visualization dashboard for managing multi-site clinical trial enrollment in two community acquired pneumonia studies. Information dashboards are useful for clinical trial management. They can be used in a standalone trial or can be included into a larger management system.

  7. Bruton's tyrosine kinase inhibitor BMS-986142 in experimental models of rheumatoid arthritis enhances efficacy of agents representing clinical standard-of-care.

    Science.gov (United States)

    Gillooly, Kathleen M; Pulicicchio, Claudine; Pattoli, Mark A; Cheng, Lihong; Skala, Stacey; Heimrich, Elizabeth M; McIntyre, Kim W; Taylor, Tracy L; Kukral, Daniel W; Dudhgaonkar, Shailesh; Nagar, Jignesh; Banas, Dana; Watterson, Scott H; Tino, Joseph A; Fura, Aberra; Burke, James R

    2017-01-01

    Bruton's tyrosine kinase (BTK) regulates critical signal transduction pathways involved in the pathobiology of rheumatoid arthritis (RA) and other autoimmune disorders. BMS-986142 is a potent and highly selective reversible small molecule inhibitor of BTK currently being investigated in clinical trials for the treatment of both RA and primary Sjögren's syndrome. In the present report, we detail the in vitro and in vivo pharmacology of BMS-986142 and show this agent provides potent and selective inhibition of BTK (IC50 = 0.5 nM), blocks antigen receptor-dependent signaling and functional endpoints (cytokine production, co-stimulatory molecule expression, and proliferation) in human B cells (IC50 ≤ 5 nM), inhibits Fcγ receptor-dependent cytokine production from peripheral blood mononuclear cells, and blocks RANK-L-induced osteoclastogenesis. Through the benefits of impacting these important drivers of autoimmunity, BMS-986142 demonstrated robust efficacy in murine models of rheumatoid arthritis (RA), including collagen-induced arthritis (CIA) and collagen antibody-induced arthritis (CAIA). In both models, robust efficacy was observed without continuous, complete inhibition of BTK. When a suboptimal dose of BMS-986142 was combined with other agents representing the current standard of care for RA (e.g., methotrexate, the TNFα antagonist etanercept, or the murine form of CTLA4-Ig) in the CIA model, improved efficacy compared to either agent alone was observed. The results suggest BMS-986142 represents a potential therapeutic for clinical investigation in RA, as monotherapy or co-administered with agents with complementary mechanisms of action.

  8. Juvenile idiopathic arthritis: clinically relevant imaging in diagnosis and monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Southwood, Tauny [Birmingham Children' s Hospital NHS Foundation Trust, Department of Rheumatology, Birmingham (United Kingdom)

    2008-06-15

    The role of plain radiographs in monitoring the disease process in JIA is being increasingly superseded by MRI. The use of ultrasound by clinicians is contentious, but has the potential to corroborate and supplement the clinical impression of individual joint inflammation and it can be very useful for localising intra-articular treatment at the bedside. There are exciting developments in MRS technology which may eventually allow in vivo evaluation of the acute inflammatory process, measurement of early responses to treatment and detection of residual inflammation. The aim of this article is to describe a clinician's view of the current role of imaging in the diagnosis and monitoring of JIA. (orig.)

  9. THE FIRST RUSSIAN STRATEGIC STUDY OF PHARMACOTHERAPY FOR RHEUMATOID ARTHRITIS (REMARCA TRIAL: RESULTS OF 12-MONTH TREATMENT IN 130 PATIENTS

    Directory of Open Access Journals (Sweden)

    D. E. Karateev

    2014-01-01

    Full Text Available To introduce treat-to-target recommendations is an important task of modern rheumatology; however, there is still a diversity of serious problems relating to a scientific rationale and a clinical one for this strategy and to the possibilities of its implementation in real clinical practice, in the rheumatology service of the Russian Federation in particular, by taking into account the specific features of funding for high-tech medical care.Objective: to determine the efficiency and safety of combined therapy with subcutaneous methotrexate (MT and biological agents (BA when using the treat-to-target strategy in patients with active early and extended-stage rheumatoid arthritis (RA who have risk factors for a poor prognosis.Subjects and methods.The results of the REMARCA (Russian InvEstigation of MethotrexAte and biologicals in eaRly aCtive inflammatory Arthritis trial of 130 patients followed up for 12 months or more were given. There was a female preponderance; mean age 48.9±13.9 years, rheumatoid factor positivity (86.9%; anti-cyclic citrullinated peptide antibody positivity (89.2%. Seventy patients formed a subgroup of early RA (disease duration ≤6 months (mean 4.17±1.39 months; 60 patients were a subgroup of advanced-stage RA (disease duration >6 months (mean 30.8±32.7 months. In all the patients, therapy was initiated by using subcutaneous MT with its rapid dose escalation up to 20–30 mg/week and the achievement of the treatment goal (low disease activity or remission was checked every 3 months and depending on the result a decision had been taken to add or not to add a biological agent (BA (a tumor necrosis factor inhibitor or abatacept. If the former was insufficiently effective, it was substituted for a BA from another class.Results. Subcutaneous MT monotherapy provided remission or low disease activity in 49 (37.7% patients; a BA was given to 81 (62.3% patients. Following 6 and 12 months, low activity or remission

  10. THE FIRST RUSSIAN STRATEGIC STUDY OF PHARMACOTHERAPY FOR RHEUMATOID ARTHRITIS (REMARCA TRIAL: RESULTS OF 12-MONTH TREATMENT IN 130 PATIENTS

    Directory of Open Access Journals (Sweden)

    D. E. Karatee

    2016-01-01

    Full Text Available To introduce treat-to-target recommendations is an important task of modern rheumatology; however, there is still a diversity of serious problems relating to a scientific rationale and a clinical one for this strategy and to the possibilitiesof its implementation in real clinical practice, in the rheumatology service of the Russian Federation in particular, by taking into account the specific features of funding for high-tech medical care.Objective: to determine the efficiency and safety of combined therapy with subcutaneous methotrexate (MT and biological agents (BA when using the treat-to-target strategy in patients with active early and extended-stage rheumatoid arthritis (RA who have risk factors for a poor prognosis.Subjects and methods. The results of the REMARCA (Russian InvEstigation of MethotrexAte and biologicals in eaRly aCtive inflammatory Arthritis trial of 130 patients followed up for 12 months or more were given. There was a female preponderance; mean age 48.9±13.9 years, rheumatoid factor positivity (86.9%; anti-cyclic citrullinated peptide anti body positivity (89.2%. Seventy patients formed a subgroup of early RA (disease duration ≤6 months (mean 4.17±1.39 months; 60 patients were a subgroup of advanced-stage RA (disease duration >6 months (mean 30.8±32.7 months. In all the patients, therapy was initiated by using subcutaneous MT with its rapid dose escalation up to 20–30 mg/week and the achievement of the treatment goal (low disease activity or remission was checked every 3 months and depending on the result a decision had been taken to add or not to add a biological agent (BA (a tumor necrosis factor inhibitor or abatacept. If the former was insufficientlyeffective, it was substituted for a BA from another class.Results. Subcutaneous MT monotherapy provided remission or low disease activity in 49 (37.7% patients; a BA was given to 81 (62.3% patients. Following 6 and 12 months, low activity or remission according to

  11. THE FIRST RUSSIAN STRATEGIC STUDY OF PHARMACOTHERAPY FOR RHEUMATOID ARTHRITIS (REMARCA TRIAL: RESULTS OF 12-MONTH TREATMENT IN 130 PATIENTS

    Directory of Open Access Journals (Sweden)

    D. E. Karateev

    2015-01-01

    Full Text Available To introduce treat-to-target recommendations is an important task of modern rheumatology; however, there is still a diversity of serious problems relating to a scientific rationale and a clinical one for this strategy and to the possibilities of its implementation in real clinical practice, in the rheumatology service of the Russian Federation in particular, by taking into account the specific features of funding for high-tech medical care. Objective: to determine the efficiency and safety of combined therapy with subcutaneous methotrexate (MT and biological agents (BA when using the treat-to-target strategy in patients with active early and extended-stage rheumatoid arthritis (RA who have risk factors for a poor prognosis. Subjects and methods. The results of the REMARCA (Russian InvEstigation of MethotrexAte and biologicals in eaRly aCtive inflammatory Arthritis trial of 130 patients followed up for 12 months or more were given. There was a female preponderance; mean age 48.9±13.9 years, rheumatoid factor positivity (86.9%; anti-cyclic citrullinated peptide antibody positivity (89.2%. Seventy patients formed a subgroup of early RA (disease duration ≤6 months (mean 4.17±1.39 months; 60 patients were a subgroup of advanced-stage RA (disease duration >6 months (mean 30.8±32.7 months. In all the patients, therapy was initiated by using subcutaneous MT with its rapid dose escalation up to 20–30 mg/week and the achievement of the treatment goal (low disease activity or remission was checked every 3 months and depending on the result a decision had been taken to add or not to add a biological agent (BA (a tumor necrosis factor inhibitor or abatacept. If the former was insufficiently effective, it was substituted for a BA from another class. Results. Subcutaneous MT monotherapy provided remission or low disease activity in 49 (37.7% patients; a BA was given to 81 (62.3% patients. Following 6 and 12 months, low activity or remission according

  12. 76 FR 51375 - Dialogues in Diversifying Clinical Trials: Successful Strategies for Engaging Women and...

    Science.gov (United States)

    2011-08-18

    ... HUMAN SERVICES Food and Drug Administration Dialogues in Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials AGENCY: Food and Drug Administration, HHS... Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials....

  13. ClinicalTrials.gov Turns 10! | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... please turn Javascript on. Feature: Clinical Trials ClinicalTrials.gov Turns 10! Past Issues / Fall 2010 Table of ... and whom to contact for more information. ClinicalTrials.gov's Helpful Features ClinicalTrials.gov has many helpful consumer ...

  14. [Clinical trials: vulnerability and ethical relativism].

    Science.gov (United States)

    Lima, Cristina

    2005-01-01

    Research in human beings is an important chapter of medical ethics. In recent years, investigation has been taken over by profit driven corporations that must guarantee the medical and commercial application of results. This new model of investigation has generated conflicts of interest in doctor-patient, researcher-subject relationship. The inevitable debate and media reaction has led. These trials of controversial design to regions of the globe where the vulnerability of the populations continues to allow their undertaking. This article includes a historical perspective on experimentation in human beings and the conditions that led to its regulation: the Nuremberg CODE, followed by the Helsinky Declaration in its different versions, and the Belmont Report, that defend the subject according to the ethic of principles used in western medicine. There is then a review of the attempts to change international regulation to reintroduce clinical trials with placebo--which since 1996 is only permitted where there are no therapeutic or diagnostic methods--on populations that would otherwise have no access to treatment. This then leads on to the issue of double standards in medical investigation defended by many investigators and some official entities. The article concludes that it may be prudent to allow local ethical commissions to approve deviation from the established norm if such is necessary to resolve urgent questions of health in the country, but it is unacceptable that any such emergency is used as a reason to reduce the ethical prerequisites, in clinical trials. It also concludes that true urgency is in making available to all who need it the effective products already in existence. Furthermore, that the acceptance of ethical relativism can result in the exploitation of vulnerable third world populations for research programmes that cannot be undertaken in their sponsoring countries due to the ethical restrictions in place.

  15. Specification of phase I of new drugs' clinical tolerance trials

    Institute of Scientific and Technical Information of China (English)

    LI Guo-xin

    2008-01-01

    Phase I of clinical trials is the first stage of clinical pharmacology and body safety evaluation, including body tolerance test and pharmacokinetics test. The aim is providing evidence for dosage regimen and be the cornerstone of the preliminary assessment of efficacy and safety of phase II of clinical trials. This text discussed the technique and requirement of phase I of new drugs' clinical tolerance trials.

  16. Citation Sentiment Analysis in Clinical Trial Papers

    Science.gov (United States)

    Xu, Jun; Zhang, Yaoyun; Wu, Yonghui; Wang, Jingqi; Dong, Xiao; Xu, Hua

    2015-01-01

    In scientific writing, positive credits and negative criticisms can often be seen in the text mentioning the cited papers, providing useful information about whether a study can be reproduced or not. In this study, we focus on citation sentiment analysis, which aims to determine the sentiment polarity that the citation context carries towards the cited paper. A citation sentiment corpus was annotated first on clinical trial papers. The effectiveness of n-gram and sentiment lexicon features, and problem-specified structure features for citation sentiment analysis were then examined using the annotated corpus. The combined features from the word n-grams, the sentiment lexicons and the structure information achieved the highest Micro F-score of 0.860 and Macro-F score of 0.719, indicating that it is feasible to use machine learning methods for citation sentiment analysis in biomedical publications. A comprehensive comparison between citation sentiment analysis of clinical trial papers and other general domains were conducted, which additionally highlights the unique challenges within this domain. PMID:26958274

  17. Statistical reasoning in clinical trials: hypothesis testing.

    Science.gov (United States)

    Kelen, G D; Brown, C G; Ashton, J

    1988-01-01

    Hypothesis testing is based on certain statistical and mathematical principles that allow investigators to evaluate data by making decisions based on the probability or implausibility of observing the results obtained. However, classic hypothesis testing has its limitations, and probabilities mathematically calculated are inextricably linked to sample size. Furthermore, the meaning of the p value frequently is misconstrued as indicating that the findings are also of clinical significance. Finally, hypothesis testing allows for four possible outcomes, two of which are errors that can lead to erroneous adoption of certain hypotheses: 1. The null hypothesis is rejected when, in fact, it is false. 2. The null hypothesis is rejected when, in fact, it is true (type I or alpha error). 3. The null hypothesis is conceded when, in fact, it is true. 4. The null hypothesis is conceded when, in fact, it is false (type II or beta error). The implications of these errors, their relation to sample size, the interpretation of negative trials, and strategies related to the planning of clinical trials will be explored in a future article in this journal.

  18. Citation Sentiment Analysis in Clinical Trial Papers.

    Science.gov (United States)

    Xu, Jun; Zhang, Yaoyun; Wu, Yonghui; Wang, Jingqi; Dong, Xiao; Xu, Hua

    2015-01-01

    In scientific writing, positive credits and negative criticisms can often be seen in the text mentioning the cited papers, providing useful information about whether a study can be reproduced or not. In this study, we focus on citation sentiment analysis, which aims to determine the sentiment polarity that the citation context carries towards the cited paper. A citation sentiment corpus was annotated first on clinical trial papers. The effectiveness of n-gram and sentiment lexicon features, and problem-specified structure features for citation sentiment analysis were then examined using the annotated corpus. The combined features from the word n-grams, the sentiment lexicons and the structure information achieved the highest Micro F-score of 0.860 and Macro-F score of 0.719, indicating that it is feasible to use machine learning methods for citation sentiment analysis in biomedical publications. A comprehensive comparison between citation sentiment analysis of clinical trial papers and other general domains were conducted, which additionally highlights the unique challenges within this domain.

  19. Subgroup identification from randomized clinical trial data.

    Science.gov (United States)

    Foster, Jared C; Taylor, Jeremy M G; Ruberg, Stephen J

    2011-10-30

    We consider the problem of identifying a subgroup of patients who may have an enhanced treatment effect in a randomized clinical trial, and it is desirable that the subgroup be defined by a limited number of covariates. For this problem, the development of a standard, pre-determined strategy may help to avoid the well-known dangers of subgroup analysis. We present a method developed to find subgroups of enhanced treatment effect. This method, referred to as 'Virtual Twins', involves predicting response probabilities for treatment and control 'twins' for each subject. The difference in these probabilities is then used as the outcome in a classification or regression tree, which can potentially include any set of the covariates. We define a measure Q(Â) to be the difference between the treatment effect in estimated subgroup  and the marginal treatment effect. We present several methods developed to obtain an estimate of Q(Â), including estimation of Q(Â) using estimated probabilities in the original data, using estimated probabilities in newly simulated data, two cross-validation-based approaches, and a bootstrap-based bias-corrected approach. Results of a simulation study indicate that the Virtual Twins method noticeably outperforms logistic regression with forward selection when a true subgroup of enhanced treatment effect exists. Generally, large sample sizes or strong enhanced treatment effects are needed for subgroup estimation. As an illustration, we apply the proposed methods to data from a randomized clinical trial.

  20. Future clinical trials in DIPG: bringing epigenetics to the clinic

    Directory of Open Access Journals (Sweden)

    Andres E. Morales La Madrid

    2015-07-01

    Full Text Available In spite of major recent advances in DIPG molecular characterization, this body of knowledge has not yet translated into better treatments.To date,more than 250 clinical trials evaluating radiotherapy along with conventional cytotoxic chemotherapy as well as newer biologic agents,have failed to improve the dismal outcome when compared to palliative radiation alone.The biology of DIPG remained unknown until recently when the neurosurgical expertise along with the recognition by the scientific and clinical community of the importance of tissue sampling at diagnosis;ideally in the context of a clinical trial and by trained neurosurgical teams to maximize patient safety.These pre-treatment tumor samples,and others coming from tissue obtained post-mortem,have yielded new insights into DIPG molecular biology.We now know that DIPG comprises a heterogeneous disease with variable molecular phenotypes, different from adult high grade glioma,other non-pontine pediatric high grade gliomas and even between pontine gliomas.The discovery of histone H3.3 or H3.1 mutations has been an important step forward in understanding tumor formation,maintenance and progression.Pharmacologic reversal of DIPG histone demethylation therefore offers an important potential intervention strategy for the treatment of DIPG.To date,clinical trials of newly diagnosed or progressive DIPG with epigenetic modifiers have been unsuccessful.Whether this failure represents limited activity of the agents used,their CNS penetration,redundant pathways within the tumor,or the possibility that histone mutations are necessary only to initiate DIPGs but not maintain their growth,suggest that a great deal still needs to be elucidated in both the underlying biology of these pathways,and the drugs designed to target them.In this review, we discuss the role of both epigenetic and genetic mutations within DIPG and the development of treatment strategies directed against the unique abnormalities

  1. Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial

    Science.gov (United States)

    Svensson, Annemarie Lyng; Løgstrup, Brian Bridal; Giraldi, Annamaria; Graugaard, Christian; Blegvad, Jesper; Thygesen, Tina; Sheetal, Ekta; Svendsen, Lone; Emmertsen, Henrik

    2016-01-01

    Introduction Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria. Methods and analysis The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, blood pressure <140/90 mm  Hg for patients without diabetes and <130/80 mm Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30 mg/g) after 1 year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1 year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60 months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60 months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia

  2. Mechanistic aspects of inflammation and clinical management of inflammation in acute gouty arthritis.

    Science.gov (United States)

    Cronstein, Bruce N; Sunkureddi, Prashanth

    2013-01-01

    It has been recently demonstrated that interleukin 1β (IL-1β) plays a central role in monosodium urate crystal-induced inflammation and that the NALP3 inflammasome plays a major role in IL-1β production. These discoveries have offered new insights into the pathogenesis of acute gouty arthritis. In this review, we discuss the molecular mechanisms by which monosodium urate crystals induce acute inflammation and examine the mechanisms of action (MOAs) of traditional anti-inflammatory drugs (e.g., nonsteroidal anti-inflammatory drugs, colchicine, and glucocorticoids) and biologic agents (e.g., the IL-1β antagonists anakinra, rilonacept, and canakinumab) to understand how their MOAs contribute to their safety profiles. Traditional anti-inflammatory agents may act on the IL-1β pathway at some level; however, their MOAs are broad-ranging, unspecific, and biologically complex. This lack of specificity may explain the range of systemic adverse effects associated with them. The therapeutic margins of nonsteroidal anti-inflammatory drugs, colchicine, and glucocorticoids are particularly low in elderly patients and in patients with cardiovascular, metabolic, or renal comorbidities that are frequently associated with gouty arthritis. In contrast, the IL-1β antagonists act on very specific targets of inflammation, which may decrease the potential for systemic adverse effects, although infrequent but serious adverse events (including infection and administration reactions) have been reported. Because these IL-1β antagonists target an early event immediately downstream from NALP3 inflammasome activation, they may provide effective alternatives to traditional agents with minimal systemic adverse effects. Results of ongoing trials of IL-1β antagonists will likely provide clarification of their potential role in the management of acute gouty arthritis.

  3. Comparative assessment of clinical response in patients with rheumatoid arthritis between PF‐05280586, a proposed rituximab biosimilar, and rituximab

    Science.gov (United States)

    Williams, Jason H.; Hutmacher, Matthew M.; Zierhut, Matthew L.; Becker, Jean‐Claude; Gumbiner, Barry; Spencer‐Green, George; Melia, Lisa A.; Liao, Kai‐Hsin; Suster, Matthew; Li, Ruifeng; Meng, Xu

    2016-01-01

    Aims To evaluate potential differences between PF‐05280586 and rituximab sourced from the European Union (rituximab‐EU) and USA (rituximab‐US) in clinical response (Disease Activity Score in 28 Joints [DAS28] and American College of Rheumatology [ACR] criteria), as part of the overall biosimilarity assessment of PF‐05280586. Methods A randomised, double‐blind, pharmacokinetic similarity trial was conducted in patients with active rheumatoid arthritis refractory to anti‐tumour necrosis factor therapy on a background of methotrexate. Patients were treated with 1000 mg of PF‐05280586, rituximab‐EU or rituximab‐US on days 1 and 15 and followed over 24 weeks for pharmacokinetic, clinical response and safety assessments. Key secondary end points were the areas under effect curves for DAS28 and ACR responses. Mean differences in areas under effect curves were compared against respective reference ranges established by observed rituximab‐EU and rituximab‐US responses using longitudinal nonlinear mixed effects models. Results The analysis included 214 patients. Demographics were similar across groups with exceptions in some baseline disease characteristics. Baseline imbalances and group‐to‐group variation were accounted for by covariate effects in each model. Predictions from the DAS28 and ACR models tracked the central tendency and distribution of observations well. No point estimates of mean differences were outside the reference range for DAS28 or ACR scores. The probabilities that the predicted differences between PF‐05280586 vs. rituximab‐EU or rituximab‐US lie outside the reference ranges were low. Conclusions No clinically meaningful differences were detected in DAS28 or ACR response between PF‐05280586 and rituximab‐EU or rituximab‐US as the differences were within the pre‐specified reference ranges. TRIAL REGISTRATION Number: NCT01526057. PMID:27530379

  4. Empowering natural clinical trial advocates: nurses and outreach workers.

    Science.gov (United States)

    Mitschke, Diane B; Cassel, Kevin; Higuchi, Paula

    2007-03-01

    Cancer clinical trials are essential to advancing the prevention and treatment of cancer, yet adult participation rates in clinical trials remain abysmal. Despite the essential contributions of clinical trials to science and medicine, adult participation in clinical trials remains exceedingly low, with only 2%-4% of all adult patients with cancer in the U.S. participating in clinical trials. Clinical trials accrual rates in Hawai'i follow this national trend of less than 3% of eligible patients participating in trials. Recognizing the need to increase awareness about clinical trials, the National Cancer Institute's Cancer Information Service-Pacific Region, through the Hawai'i Clinical Trials Education Coalition, has employed strategic dissemination plans to train and educate key target audiences, including registered nurses, nursing students, and community outreach workers about the availability of over 90 cancer clinical trials in Hawai'i. Previous research suggests that nurses often play a vital role in increasing a patient's understanding of clinical trials and may also act as a patient advocate in regards to participation in a clinical trial. A train-the-trainer model curriculum was developed using the Clinical Trials Education Series (CTES), a collection of multi-level resources designed by the National Cancer Institute, to educate various constituents about clinical trials. The training curriculum and workshop format is adapted based on both formal and informal needs assessments conducted with audiences prior to the planned training, yet key elements remain central to the training model. In addition, an interactive, internet-based case study was developed using local place names and cultural cues to allow training participants to engage in realistic and practical methods for locating and sharing information about clinical trials with patients and the public. This training model has been implemented in a variety of settings including three statewide nursing

  5. Prevalence Of Lung Involvement Due To Rheumatoid Arthritis Based On Clinical, Radiographic And Pulmonary Functions Test

    Directory of Open Access Journals (Sweden)

    Sedighi N

    2004-07-01

    Full Text Available Background: Pulmonary involvement is a common and serious complication of rheumatoid arthritis. This cross sectional study sought to determine the prevalence of pulmonary disease in patients with rheumatoid arthritis on the basis of history, physical examination, chest X-ray and PFT. Materials and Methods: 103 patients (81 Women, 22 Men fulfilling the ACR (American College of Rheumatology criteria for RA (Rheumatoid arthritis were consecutively included in a cross sectional study. Detailed medical (including respiratory symptoms and the disease activity symptoms and drug and occupational histories and smoking were obtained. All patients underwent a complete pulmonary and rheumatologic examination and conventional chest radiography. All patients underwent PFT that comprised spirometry and body plethysmography. Results for PFTs were expressed as percentage of predicted values for each individual adjusted for age, sex, and height. Results: On the basis of history: Their mean age was 43.3 ± 2.6 years (range: 17-74 and the mean duration of the disease was 69.3 ± 15.6 months. Rheumatoid factor was positive in% 61.2. No patients were 0.5Pack/Year smoker in whole life. Prevalence of pulmonary involvement based on radiographic and pulmonary function test detected in 41 patients (39/7%. The most frequent respiratory clinical finding was dyspnea (33%, (NYHA grade I in 17.5% and NYHA grade II in 15.5%, Cough (with or without sputum in 13.6 %, Crackle was the most sign in pulmonary examination (5.8%. Chest X-ray was abnormal in 13.3 % that the most common finding in this study was reticulonodular pattern in 20 patients (19.4 %, and pleural effusion detected in 7 patients (6.7%. PFT was abnormal in 30 patients (29.1 %. A significant decrease of FEF 25%-75% below 1.64 SD. Small airway involvements was the most abnormal finding of PFT. No relation between rheumatoid arthritis disease activity (ESR>30, Morning stiffness>30', Anemia, thrombocytosis with

  6. Synovitis and osteitis are very frequent in rheumatoid arthritis clinical remission: results from an MRI study of 294 patients in clinical remission or low disease activity state

    DEFF Research Database (Denmark)

    Gandjbakhch, Frédérique; Conaghan, Philip G; Ejbjerg, Bo;

    2011-01-01

    In rheumatoid arthritis (RA), radiographic progression may occur despite clinical remission. This may be explained by subclinical inflammation. Magnetic resonance imaging (MRI) provides a greater sensitivity than clinical examination and radiography for assessing disease activity. Our objective w...... was to determine the MRI characteristics of RA patients in clinical remission or low disease activity (LDA) state....

  7. Bacteriophage Therapy: Advances in Formulation Strategies and Human Clinical Trials.

    Science.gov (United States)

    Vandenheuvel, Dieter; Lavigne, Rob; Brüssow, Harald

    2015-11-01

    Recently, a number of phage therapy phase I and II safety trials have been concluded, showing no notable safety concerns associated with the use of phage. Though hurdles for efficient treatment remain, these trials hold promise for future phase III clinical trials. Interestingly, most phage formulations used in these clinical trials are straightforward phage suspensions, and not much research has focused on the processing of phage cocktails in specific pharmaceutical dosage forms. Additional research on formulation strategies and the stability of phage-based drugs will be of key importance, especially with phage therapy advancing toward phase III clinical trials.

  8. Sponsorship and design characteristics of trials registered in ClinicalTrials.gov.

    Science.gov (United States)

    Roumiantseva, Dina; Carini, Simona; Sim, Ida; Wagner, Todd H

    2013-03-01

    We examine the extent to which ClinicalTrials.gov is meeting its goal of providing oversight and transparency of clinical trials with human subjects. We analyzed the ClinicalTrials.gov database contents as of June 2011, comparing interventions, medical conditions, and trial characteristics by sponsor type. We also conducted a detailed analysis of incomplete data. Among trials with only government sponsorship (N=9252), 36% were observational and 64% interventional; in contrast, almost all (90%) industry-only sponsored trials were interventional. Industry-only sponsored interventional trials (N=30,036) were most likely to report a drug intervention (81%), followed by biologics (9%) and devices (8%). Government-only interventional trials (N=5886) were significantly more likely to test behavioral interventions (28%) and procedures (13%) than industry-only trials (pgov. Published by Elsevier Inc.

  9. Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

    Directory of Open Access Journals (Sweden)

    S. Kannan

    2016-03-01

    Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

  10. Imaging of the temporomandibular joint in juvenile idiopathic arthritis.

    Science.gov (United States)

    Vaid, Yoginder N; Dunnavant, F Daniel; Royal, Stuart A; Beukelman, Timothy; Stoll, Matthew L; Cron, Randy Q

    2014-01-01

    Temporomandibular joint (TMJ) arthritis in children with juvenile idiopathic arthritis (JIA) is extremely common but frequently asymptomatic. Magnetic resonance imaging (MRI) with contrast remains the gold standard for identifying TMJ arthritis in JIA. A reliable scoring system with published MRI examples of typical acute and chronic TMJ arthritis changes will be invaluable for future prospective treatment trials of TMJ arthritis in JIA. MRIs were collected from routine clinical studies assessing TMJ arthritis in JIA. Representative images were selected for publication to depict acute (synovial fluid, bone marrow edema, and synovial enhancement) and chronic (pannus, disc derangement, and condylar head flattening and erosions) TMJ arthritis findings. A preliminary MRI-based scoring system for assessing degrees of acute and chronic TMJ arthritis was developed and tested for inter- and intrareader reliability. TMJ MRIs representative of acute and chronic TMJ arthritis in JIA were selected from among thousands taken (>500 TMJ MRI studies annually at Children's of Alabama) since September 2007. Moreover, computed tomography scans depicting select bony changes (osteophyte formation, micrognathia) were chosen for publication. A description of the MRI protocol for assessing TMJ arthritis is included. A preliminary scoring system weighted for degree of acute and chronic TMJ arthritis MRI findings was found to have substantial inter- and intrareader reliability. A published set of MRIs depicting representative acute and chronic changes will help establish a standardized scoring system to assess TMJ arthritis in children with JIA. Future validation will aid in assessing improvement during treatment trials of TMJ arthritis. Copyright © 2014 by the American College of Rheumatology.

  11. Immune checkpoints in cancer clinical trials

    Institute of Scientific and Technical Information of China (English)

    Elad Sharon; Howard Streicher; Priscila Goncalves; Helen XChen

    2014-01-01

    Immunology-based therapy is rapidly developing into an effective treatment option for a surprising range of cancers. We have learned over the last decade that powerful immunologic effector cells may be blocked by inhibitory regulatory pathways controlled by specific molecules often called“immune checkpoints.” These checkpoints serve to control or turn off the immune response when it is no longer needed to prevent tissue injury and autoimmunity. Cancer cells have learned or evolved to use these mechanisms to evade immune control and elimination. The development of a new therapeutic class of drugs that inhibit these inhibitory pathways has recently emerged as a potent strategy in oncology. Three sets of agents have emerged in clinical trials exploiting this strategy. These agents are antibody-based therapies targeting cytotoxic T-lymphocyte antigen4 (CTLA4), programmed cell death1 (PD-1), and programmed cell death ligand 1 (PD-L1). These inhibitors of immune inhibition have demonstrated extensive activity as single agents and in combinations. Clinical responses have been seen in melanoma, renal cellcarcinoma, non-smal celllung cancer, and several other tumor types. Despite the autoimmune or inflammatory immune-mediated adverse effects which have been seen, the responses and overall survival benefits exhibited thus far warrant further clinical development.

  12. Clinical trials in branch retinal vein occlusion

    Directory of Open Access Journals (Sweden)

    Tandava Krishnan Panakanti

    2016-01-01

    Full Text Available Branch retinal vein occlusion (BRVO is the second most common retinal vascular disorder. The management of macular edema has changed considerably over time. The laser is considered the gold standard treatment for over two decades. However, visual recovery with laser is usually slow and incomplete. The advent of intravitreal agents, specifically anti-vascular endothelial growth factors (VEGF have heralded a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have reported optimal results with anti-VEGF agents (ranibizumab, bevacizumab, and aflibercept compared to laser therapy or steroids. However, nearly 50% of the patients require repeat intravitreal anti-VEGF therapy up to 4 years after initiating therapy to sustain the visual gains. The adverse events (systemic and ocular of these agents are minimal. Monotherapy with anti-VEGF agents have been found to provide better results than any combination with laser. This review article summarizes evidence from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special focus on anti-VEGF therapy.

  13. Clinical Trials in Branch Retinal Vein Occlusion

    Science.gov (United States)

    Panakanti, Tandava Krishnan; Chhablani, Jay

    2016-01-01

    Branch retinal vein occlusion (BRVO) is the second most common retinal vascular disorder. The management of macular edema has changed considerably over time. The laser is considered the gold standard treatment for over two decades. However, visual recovery with laser is usually slow and incomplete. The advent of intravitreal agents, specifically anti-vascular endothelial growth factors (VEGF) have heralded a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have reported optimal results with anti-VEGF agents (ranibizumab, bevacizumab, and aflibercept) compared to laser therapy or steroids. However, nearly 50% of the patients require repeat intravitreal anti-VEGF therapy up to 4 years after initiating therapy to sustain the visual gains. The adverse events (systemic and ocular) of these agents are minimal. Monotherapy with anti-VEGF agents have been found to provide better results than any combination with laser. This review article summarizes evidence from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special focus on anti-VEGF therapy. PMID:26957837

  14. Spa therapy adjunct to pharmacotherapy is beneficial in rheumatoid arthritis: a crossover randomized controlled trial.

    Science.gov (United States)

    Karagülle, Mine; Kardeş, Sinan; Dişçi, Rian; Karagülle, Müfit Zeki

    2017-09-07

    This study aims to investigate whether 2-week spa therapy, as an adjunct to usual pharmacological therapy, has any beneficial effect in patients with rheumatoid arthritis (RA). In this single-blind crossover study, 50 patients were randomly assigned in a 1:1 manner to receive usual pharmacological therapy plus 2-week spa therapy or usual pharmacological therapy alone (period 1.6 months); after a 9-month washout, patients were crossed over to the opposite assignment (period 2.6 months). Spa therapy program included a daily saline balneotherapy session at 36-37 °C for 20 min except Sundays. The clinical outcomes were evaluated at baseline, after spa therapy (2 weeks) and 3 and 6 months after the spa therapy in both period and were pain (Visual Analogue Scale (VAS)), patient and physician global assessments (VAS), Health Assessment Questionnaire (HAQ), and Disease Activity Score (DAS28). Spa therapy was superior to control therapy in improving all the assessed clinical outcomes at the end of the spa therapy. This superiority persisted significantly in physician global assessment (p = 0.010) and with a trend in favor of spa group in patient global assessment (p = 0.058), function (p = 0.092), and disease activity (p = 0.098) at 3 months. Statistically significant improvements were found in spa therapy compared to control in disease activity (p = 0.006) and patient (p = 0.020) and physician global (p = 0.011) assessments, and a trend toward improvements in pain (p = 0.069) and swollen joints (p = 0.070) at 6 months. A 2-week spa therapy adjunct to usual pharmacological therapy provided beneficial clinical effects compared to usual pharmacological therapy alone, in RA patients treated with traditional disease-modifying antirheumatic drugs. These beneficial effects may last for 6 months.

  15. Publication bias in clinical trials of electronic health records.

    Science.gov (United States)

    Vawdrey, David K; Hripcsak, George

    2013-02-01

    To measure the rate of non-publication and assess possible publication bias in clinical trials of electronic health records. We searched ClinicalTrials.gov to identify registered clinical trials of electronic health records and searched the biomedical literature and contacted trial investigators to determine whether the results of the trials were published. Publications were judged as positive, negative, or neutral according to the primary outcome. Seventy-six percent of trials had publications describing trial results; of these, 74% were positive, 21% were neutral, and 4% were negative (harmful). Of unpublished studies for which the investigator responded, 43% were positive, 57% were neutral, and none were negative; the lower rate of positive results was significant (pelectronic health record studies is similar to that in other biomedical studies. There appears to be a bias toward publication of positive trials in this domain. Copyright © 2012 Elsevier Inc. All rights reserved.

  16. Drug interactions in controlled clinical trials.

    Science.gov (United States)

    Gershon, S

    1982-12-01

    As much information as possible should be obtained in clinical trials to assess possible interactions between test drugs and concomitant medications prescribed for other medical indications. Side effect profiles were compared in patients taking buspirone, mean = 20 mg/day; diazepam, 20 mg/day; clorazepate, 23 mg/day; and placebo, with or without concomitant medications. Approximately 1,000 anxious patients were included in the analysis; 700 received buspirone. The use of a variety of common medications did not affect the side effect profile in the buspirone, clorazepate, and placebo groups, but did increase the incidence of side effects in the diazepam group. The increased incidence of sedation noted with diazepam and clorazepate, however, was not due to concomitant medication.

  17. Recruitment and Retention of Patients into Emergency Medicine Clinical Trials

    OpenAIRE

    Cofield,Stacey; Conwit, Robin; Barsan, William; Quinn, James

    2010-01-01

    The emergency medicine and pre-hospital environments are unlike any other clinical environments and require special consideration to allow the successful implementation of clinical trials. This article reviews the specific issues involved in Emergency Medicine Clinical Trials (EMCT), and provides strategies from emergency medicine and non-emergency medicine trials to maximize recruitment and retention. While the evidence supporting some of these strategies is deficient, addressing recruitment...

  18. Biopharmaceutical industry-sponsored global clinical trials in emerging countries

    OpenAIRE

    Lenio Souza Alvarenga; Elisabeth Nogueira Martins

    2010-01-01

    OBJECTIVE: To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. METHODS: Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial pl...

  19. Perceptions of reimbursement for clinical trial participation.

    Science.gov (United States)

    Breitkopf, Carmen Radecki; Loza, Melissa; Vincent, Kathleen; Moench, Thomas; Stanberry, Lawrence R; Rosenthal, Susan L

    2011-09-01

    A greater understanding of participant views regarding reimbursement will help investigators plan studies that have better potential for reaching target enrollment, maximize efficient recruitment, maintain scientific integrity, and enhance retention over time. As part of a clinical trial in the area of sexual health, healthy women's perceptions of reimbursement for research participation were investigated. Semi-structured, audio-recorded, qualitative interviews were conducted immediately upon women's completion of the clinical trial to enable a participant-driven understanding of perceptions about monetary reimbursement. Audio-recordings were transcribed and analyzed using framework analysis. Women (N = 30) had a mean age of 29.5 ± 5.7 years (range 22-45 years). Sixty-three percent of participants (n = 19) were non-Hispanic (white n = 13, black n = 4, and Asian n = 2), while the remaining were Hispanic (n = 11). Seventy-three percent (n = 22) reported previous participation in research. In general, women viewed reimbursement as a benefit to research participation, the amount of which should reflect time, the inconvenience to the research subject, and the potential for unknown risks in the short- and long-term. They believed reimbursement should take into account the degree of risk of the study, with investigations of experimental products offering greater reimbursement. Women believed that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable. The results of this study can be used to provide guidance to those planning and evaluating reimbursement for research participation.

  20. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Directory of Open Access Journals (Sweden)

    Joseph S Ross

    2009-09-01

    Full Text Available BACKGROUND: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication. METHODS AND FINDINGS: We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006. CONCLUSIONS: Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low

  1. Clinical factors, anticitrullinated peptide antibodies and MRI-detected subclinical inflammation in relation to progression from clinically suspect arthralgia to arthritis.

    Science.gov (United States)

    van Steenbergen, Hanna W; Mangnus, Lukas; Reijnierse, Monique; Huizinga, Tom W J; van der Helm-van Mil, Annette H M

    2016-10-01

    Patients with clinically suspect arthralgia (CSA) have, according to their rheumatologists, an increased risk of rheumatoid arthritis (RA), but their actual outcome is unexplored. This longitudinal study investigated (1) progression from CSA to clinically detectable arthritis and (2) associations of clinical factors, serological factors (among which are anticitrullinated peptide antibodies (ACPAs)) and MRI-detected subclinical inflammation with arthritis development. 150 patients with CSA were followed for ≥6 months. At baseline, clinical and serological data were collected and unilateral 1.5 T-MRI of metacarpophalangeal (MCP), wrist and metatarsophalangeal (MTP) joints was made. MRI scoring was done according to the RA MRI scoring system. Subclinical MRI inflammation was defined based on MRI results of 193 symptom-free persons. During follow-up (median=75 weeks, IQR=41-106 weeks), 30 patients developed clinical arthritis; 87% did so <20 weeks after inclusion. In multivariable analyses, age, localisation of initial symptoms in small and large joints (compared with small joints only), C-reactive protein level, ACPA-positivity and subclinical MRI inflammation significantly associated with arthritis development; ACPA and MRI inflammation were most strongly associated (HR (95% CI) respectively, 6.43 (2.57 to 16.05) and 5.07 (1.77 to 14.50)). After 1-year follow-up, 31% of the patients with MRI inflammation and 71% of the ACPA-positive patients with MRI inflammation had progressed to arthritis. Forty-three per cent of the patients that developed arthritis within 1 year were ACPA-negative; 78% of them had subclinical MRI inflammation at baseline. When MRI inflammation was absent arthritis development was infrequent (6% in all patients with CSA and 3% in ACPA-negative patients with CSA). Subclinical MRI inflammation precedes clinical arthritis with a few months. Subclinical MRI inflammation is, independent of other factors such as ACPA, associated with

  2. Exploring Willingness to Participate in Clinical Trials by Ethnicity.

    Science.gov (United States)

    Pariera, Katrina L; Murphy, Sheila T; Meng, Jingbo; McLaughlin, Margaret L

    2016-09-07

    African-Americans and Hispanic-Americans are disproportionately affected by cancer, yet underrepresented in cancer clinical trials. Because of this, it is important to understand how attitudes and beliefs about clinical trials vary by ethnicity. A national, random sample of 860 adults was given an online survey about attitudes toward clinical trials. We examined willingness to participate in clinical trials, attitudes toward clinical trials, trust in doctors, attitudes toward alternative and complementary medicine, and preferred information channels. Results indicate that African-American and Hispanic-American participants have more negative attitudes about clinical trials, more distrust toward doctors, more interest in complementary and alternative medicine, and less willingness to participate in clinical trials than white/non-Hispanics, although specific factors affecting willingness to participate vary. The channels people turn to for information on clinical trials also varied by ethnicity. These results help explain the ethnic disparities in cancer clinical trial enrollment by highlighting some potential underlying causes and drawing attention to areas of importance to these groups.

  3. Recruitment and Retention of Patients into Emergency Medicine Clinical Trials

    Science.gov (United States)

    Cofield, Stacey; Conwit, Robin; Barsan, William; Quinn, James

    2010-01-01

    The emergency medicine and pre-hospital environments are unlike any other clinical environments and require special consideration to allow the successful implementation of clinical trials. This article reviews the specific issues involved in Emergency Medicine Clinical Trials (EMCT), and provides strategies from emergency medicine and non-emergency medicine trials to maximize recruitment and retention. While the evidence supporting some of these strategies is deficient, addressing recruitment and retention issues with specific strategies will help researchers deal with these issues in their funding applications and in turn develop the necessary infrastructure to participate in emergency medicine clinical trials. PMID:21040112

  4. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  5. Primary Clinical Evaluation of the Joint Replacement for the Treatment of the First Metatarsophalangeal Arthritis

    Institute of Scientific and Technical Information of China (English)

    Qi-yi Li; Jin Jin; Xi-sheng Weng; Jin Lin; Yi-dan Zhang; Gui-xing Qiu

    2011-01-01

    Objective To retrospectively assess the primary clinical results of a cohort of the first metatarsophalangeal joint replacement with double-stemmed hinge silicone implant. Methods A total of 12 patients (15 feet) received the joint replacement with double-stemmed hinge silicone implant. There were 2 males and 10 females with a mean age of 61.4 (range, 56-75) years old. Of them, 9 cases (11 feet) were hallux valgus with osteoarthritis; 1 case (2 feet) was rheumatic arthritis; 2 cases (2 feet) were traumatic arthritis. The subjective and objective results were evaluated during follow-up.Results All of the patients were followed up regularly with an average of 24.7 months, ranging from 12 to 38 months. Ten patients were completely satisfied with the operation; 1 patient showed partial satisfaction, and 1 patient was not satisfied because of the first matatarsophalangeal joint pain due to severe hyperosteogeny surrounding the cut bone surface 3 years after the operation. Osteolysis around the implant occurred in 2 cases without clinical symptoms, and no special treatment was given.Conclusion The joint replacement is a preferable method in alleviating pain and improving walking function with proper indication.

  6. Acute gouty arthritis and rapidly progressive renal failure as manifestation of multiple myeloma: clinical case description

    Directory of Open Access Journals (Sweden)

    O.V. Gudym

    2017-09-01

    Full Text Available The article describes a clinical case of multiple myeloma in 78-year-old man, its clinical onset was as an acute attack of gout. The patient was admitted to hospital due to the development of the first acute attack of gout. The attack was characterized by polyarthricular joint lesion of the upper and lower extremities, pronounced inflammatory reaction, insufficient response to the use of non-steroidal anti-inflammatory drugs, and a high level of hyperuricemia. The serum uric acid concentration ranged from 636 to 712 μmol/l. The study of the synovial fluid of the inflamed knee joint made it possible to reveal uric acid crystals and to confirm the diagnosis of acute gouty arthritis. Simultaneously, the patient had significant renal impairment: creatinine was 574 μmol/l, urea — 39.9 mmol/l, glomerular filtration rate according to CKD-EPI — 8 ml/min. The daily proteinuria was 1.8 g. A retrospective assessment of laboratory parameters allowed to reveal completely normal indicators of renal function 6 months ago. Considering the development of acute gouty arthritis, its polyarticular nature, persistent course, rapid involvement of new joints, high uric acid levels during an acute attack exceeding 600 μmol/l (10 mg/dL, rapid development of renal failure within 6 months until the terminal stage, it was suggested the secondary nature of gout on the background of kidney damage by another pathological process. Further clinical, laboratory and instrumental studies allowed verifying multiple myeloma with renal damage. Bence Jones protein in the urine was not detected, there was also no evidence of hyperproteinemia. However, pain in the spine, ribs and chest was the basis for carrying out an X-ray study of the bones of the skeleton. Changes in the skeleton typical for multiple myeloma have been identified. Myelogram showed a high content of plasma cells (21.1 %, electrophoresis of blood proteins showed a high M-gradient (30.42 %, and a cytochemical

  7. [Acupuncture clinical trials published in high impact factor journals].

    Science.gov (United States)

    Hu, Min; Liu, Jian-Ping; Wu, Xiao-Ke

    2014-12-01

    Acupuncture clinical trials are designed to provide reliable evidence of clinical efficacy, and SCI papers is one of the high-quality clinical efficacy of acupuncture research. To analyze these papers published in high impact factor journals on acupuncture clinical trials, we can study clinical trials from design to implementation, the efficacy of prevention and cure, combined with international standard practices to evaluate the effectiveness and safety of acupuncture. That is the core of acupuncture clinical trials, as well as a prerequisite for outstanding academic output. A scientific and complete acupuncture clinical trial should be topically novel, designed innovative, logically clear, linguistically refining, and the most important point lies in a great discovery and solving the pragmatic problem. All of these are critical points of papers to be published in high impact factor journal, and directly affect international evaluation and promotion of acupuncture.

  8. Open-access clinical trial registries: the Italian scenario

    Directory of Open Access Journals (Sweden)

    Mosconi Paola

    2012-10-01

    Full Text Available Abstract Background Citizens, patients and their representatives are increasingly insisting on working with health professionals to organize and discuss research protocols. The International Committee of Medical Journal Editors recommended setting up a public clinical trial registry where anyone can find key information about a trial. Around the world, governments have, in fact, now begun to legislate mandatory disclosure of all clinical trials. The aims of the present survey were to assess the availability of clinical trial registries for Italian citizens and to examine the transparency of the data items reported. Methods The availability of open-access clinical trial registries was surveyed on a sample of 182 websites, including research institutes and centers of excellence (IRCCS-teaching hospitals, hospitals and associations. For each registry we downloaded a sample of two trials to assess the correspondence of the data items reported. Results from the Italian and international registries were compared. Results Fifteen percent of the sample had an open-access registry of clinical trials. Comparison of the data items available, in terms of completeness and transparency, from institutional and international registries indicated wide variability. Conclusions Italian citizens, patients and their associations have scant access to local registries of clinical trials, and international registries are generally more informative. On the European level, advocacy and lobby actions are needed among citizens and patients to boost the diffusion of open-access clinical trial registries without language barriers, thereby facilitating participation, access to information, and the coordination of clinical research.

  9. Clinical trials of chemotherapy for falciparum malaria.

    Science.gov (United States)

    Winstanley, P; Olliaro, P

    1998-02-01

    Plasmodium falciparum remains one of the World's most prevalent and devastating pathogens. Mainly for economic reasons, the parasite's ability to develop resistance to drugs has not been matched by the rate at which new compounds are developed. Even so, there are new drugs (or new combinations of old drugs) currently under investigation, or in the process of development (at the moment): Pyronaridine, a well-tolerated, synthetic drug that may have utility for multi-resistant falciparum malaria in many parts of the world; however,problems remain over the formulation of this drug (which is a major determinant of its bioavailability) and its eventual cost. Chlorproguanil-dapsone (lap dap) is being studied as a possible low-cost'successor' to pyrimethamine-sulfadoxine; the utility of chlorproguanil-dapsone as 'salvage' therapy for clinical cases of pyrimethamine-sulfadoxine failure has yet to be tested in clinical trials. Atovaquone-proguanil (malarone) has utility against multi-resistant parasites; however, it is likely to be expensive (but is currently being provided free-of-charge in certain areas of Africa). Artemether-benflumetol (coartemether) combines the advantages of artemether (a rapid reduction in parasite load) with a second drug that reduces the risk of recrudescence; the cost of this combination is unclear. Rectal artesunate is being studied as an intervention to reduce the proportion of children with falciparum malaria who deteriorate to severe disease; the formulation is appropriate for use in rural health centres.

  10. Effects of Person-Centered Physical Therapy on Fatigue-Related Variables in Persons With Rheumatoid Arthritis: A Randomized Controlled Trial.

    Science.gov (United States)

    Feldthusen, Caroline; Dean, Elizabeth; Forsblad-d'Elia, Helena; Mannerkorpi, Kaisa

    2016-01-01

    To examine effects of person-centered physical therapy on fatigue and related variables in persons with rheumatoid arthritis (RA). Randomized controlled trial. Hospital outpatient rheumatology clinic. Persons with RA aged 20 to 65 years (N=70): intervention group (n=36) and reference group (n=34). The 12-week intervention, with 6-month follow-up, focused on partnership between participant and physical therapist and tailored health-enhancing physical activity and balancing life activities. The reference group continued with regular activities; both groups received usual health care. Primary outcome was general fatigue (visual analog scale). Secondary outcomes included multidimensional fatigue (Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire) and fatigue-related variables (ie, disease, health, function). At posttest, general fatigue improved more in the intervention group than the reference group (P=.042). Improvement in median general fatigue reached minimal clinically important differences between and within groups at posttest and follow-up. Improvement was also observed for anxiety (P=.0099), and trends toward improvements were observed for most multidimensional aspects of fatigue (P=.023-.048), leg strength/endurance (P=.024), and physical activity (P=.023). Compared with the reference group at follow-up, the intervention group improvement was observed for leg strength/endurance (P=.001), and the trends toward improvements persisted for physical (P=.041) and living-related (P=.031) aspects of fatigue, physical activity (P=.019), anxiety (P=.015), self-rated health (P=.010), and self-efficacy (P=.046). Person-centered physical therapy focused on health-enhancing physical activity and balancing life activities showed significant benefits on fatigue in persons with RA. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  11. Development and delivery of an exercise intervention for rheumatoid arthritis: strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial.

    Science.gov (United States)

    Heine, P J; Williams, M A; Williamson, E; Bridle, C; Adams, J; O'Brien, A; Evans, D; Lamb, S E

    2012-06-01

    This paper describes the development and implementation of a hand exercise intervention for rheumatoid arthritis (RA) as part of a large multi-centred randomised controlled trial in a U.K. National Health Service (NHS) setting. Participants are eligible if diagnosed with RA according to American College of Rheumatology criteria, have a history of disease activity, functional deficit or impairment in the hand and/or wrist, and have been on a stable medication regime for at least 3 months. The intervention development was informed by the current evidence base, published guidelines, clinician and expert opinion, and a pilot study. The exercise programme targets known, potentially modifiable physical impairments of the hand with 5 exercise sessions and a home exercise component over a 12 week period. The intervention will be provided to 240 participants along with usual care. A further 240 will receive usual care only as part of the control arm. Specific details of the treatments delivered are described. [ISRCTN no: 89936343].

  12. Anti-citrullinated protein antibodies (ACPA) in rheumatoid arthritis : linking genetic predisposition to clinical outcome

    NARCIS (Netherlands)

    Woude, Diane van der

    2012-01-01

    Rheumatoid arthritis (RA) is a disease characterized by arthritis of mainly the small joints of the hands and feet, which is thought to be the result of an autoimmune response. It is the most common inflammatory arthritis with a prevalence of 0.5-1.0% in European and North-American populations 1. Th

  13. Management of Early Rheumatoid Arthritis: Solving the unresolved the tREACH trial

    NARCIS (Netherlands)

    P.H.P. de Jong (Pascal Hendrik Pieter)

    2013-01-01

    markdownabstract__Abstract__ Rheumatoid arthritis (RA) is a systemic auto-immune disease, which is characterized by chronic inflammation of multiple joints. About 1% of the people in western countries have RA, and each year in 5 – 50 per 100.000 persons the diagnose of RA is made. The prevalence of

  14. A double blind randomized controlled trial of Maharishi Vedic vibration technology in subjects with arthritis.

    Science.gov (United States)

    Nader, T A; Smith, D E; Dillbeck, M C; Schanbacher, V; Dillbeck, S L; Gallois, P; Beall-Rougerie, S; Schneider, R H; Nidich, S I; Kaplan, G P; Belok, S

    2001-04-01

    To explore ancient Vedic medical techniques, one hundred and seventy-six subjects with arthritis participated in a controlled study through the non-pharmacologic approach known as the Maharishi Vedic Vibration Technology (MVVT). Using a double-blinded and randomized experimental design, the findings showed significant reductions of pain and stiffness, and improvement in range of motion in the study sample. One hundred percent relief of symptoms was the most commonly reported category of improvement due to treatment. For the group as a whole, differences in mean response of treatment and control conditions with respect to relief of pain, limitation of motion, and reduction in stiffness were highly significant: t values ranged from a low of 5.609 in stiffness to a high of 20.950 in pain, p = 0.000009 to <10-49 respectively. Analysis by sub-categories of peripheral arthritis, painful conditions of the spine, and rheumatoid arthritis likewise produced significant results. Mechanisms of action were proposed, drawing on Maharishi Vedic Science, developments in quantum field theory, and specifically the theories of chaos and self-organizing systems as they relate to physiological functioning. The instantaneous relief of pain and improvement in function in such a high proportion of subjects with chronic arthritis is unparalleled in modern medical science

  15. Clinical efficacy of Shiva Guggulu and Simhanada Guggulu in Amavata (Rheumatoid Arthritis).

    Science.gov (United States)

    Pandey, Shweta A; Joshi, Nayan P; Pandya, Dilip M

    2012-04-01

    Amavata is the second most common joint disorders. Nowadays erroneous dietary habits, lifestyle and environment have led to various autoimmune disorders i.e. Amavisajanya Vikaara and Amavata is one among them. Rheumatoid arthritis can be correlated with Amavata in view of its clinical features. Many research studies have been done to solve this clinical enigma, but an effective, safe, less complicated treatment is still required for the management of Amavata. In the present study, 24 patients of Amavata were registered and randomly grouped into two. In group A, Shiva Guggulu 6 g/day in divided doses and in group B, Simhanada Guggulu 6 g/day in divided doses were given for 8 weeks. On analysis of the results, it was found that Simhanada Guggulu provided better results as compared to Shiva Guggulu in the management of Amavata.

  16. Correlation of Demographic and Clinical Characteristics with Rheumatoid Factor Seropositivity in Rheumatoid Arthritis Patients.

    Science.gov (United States)

    Othman, Maizatul Akmal; Ghazali, Wan Syamimee Wan; Yahya, Nurul Khaiza; Wong, Kah Keng

    2016-11-01

    The rheumatoid factor (RF) blood test is the most commonly adopted test for the diagnosis of rheumatoid arthritis (RA). RA patients who are seropositive for RF might face a greater likelihood of developing more aggressive symptoms. Our goal was to study the demographic and clinical characteristics, as well as their correlation with RF seropositivity, among a series of 80 RA patients aged ≥ 18 years who attend Hospital Universiti Sains Malaysia (HUSM). Of the 80 RA patients included in this study, 66 (82.5%) were female and 14 (17.5%) were male. No significant associations between RF seropositivity and demographic and/or clinical characteristics or other laboratory investigations were observed, including gender, morning stiffness, individual joint involvement (from multiple sites of the body), and erythrocyte sedimentation rate (ESR) measurement. However, a significant association between RF seropositivity and patients aged ≥ 50 was found (P = 0.032). RF seropositivity was found to be more common in much older RA patients.

  17. Application of the GRAPPA psoriatic arthritis treatment recommendations in clinical practice.

    LENUS (Irish Health Repository)

    Mumtaz, Aizad

    2012-02-01

    Psoriatic disease presents with a complex array of clinical features, including peripheral synovitis and skin psoriasis, but there is also variable involvement of the nail, dactylitis, enthesitis, and spinal disease. Composite assessment of disease activity and response taking into account the impact of the disease as a whole on an individual\\'s health and quality of life is of vital importance. Following an extensive literature review, discussions, and consensus, the Group for Research in Psoriasis and Psoriatic Arthritis (GRAPPA) published guidelines to help clinicians make treatment decisions. The utility of these guidelines in routine clinical practice is further enhanced by incorporating them into a Composite Psoriatic Disease Activity Index (CPDAI). The potential application of the CPDAI in typical psoriatic disease patients is presented and discussed. Validation and possible modification of a composite disease activity and responder index is currently being undertaken by GRAPPA.

  18. Factors predicting publication of spinal cord injury trials registered on www.ClinicalTrials. gov.

    Science.gov (United States)

    DePasse, J Mason; Park, Sara; Eltorai, Adam E M; Daniels, Alan H

    2017-08-11

    Treatment options for spinal cord injuries are currently limited, but multiple clinical trials are underway for a variety of interventions, drugs, and devices. The Food and Drug Administration website www.ClinicalTrials.gov catalogues these trials and includes information on the status of the trial, date of initiation and completion, source of funding, and region. This investigation assesses the factors associated with publication and the publication rate of spinal cord injury trials. Retrospective analysis of publically available data on www.ClinicalTrials.gov. The www.ClinicalTrials.gov was queried for all trials on patients with spinal cord injury, and these trials were assessed for status, type of intervention, source of funding, and region. Multiple literature searches were performed on all completed trials to determine publication status. There were 626 studies identified concerning the treatment of patients with spinal cord injury, of which 250 (39.9%) were completed. Of these, only 119 (47.6%) were published. There was no significant difference in the rate of publication between regions (p> 0.16) or by study type (p> 0.29). However, trials that were funded by the NIH were more likely to be published than trials funded by industry (p= 0.01). The current publication rate of spinal cord injury trials is only 47.6%, though this rate is similar to the publication rate for trials in other fields. NIH-funded trials are significantly more likely to become published than industry-funded trials, which could indicate that some trials remain unpublished due to undesirable results. However, it is also likely that many trials on spinal cord injury yield negative results, as treatments are often ineffective.

  19. Gouty arthritis

    Energy Technology Data Exchange (ETDEWEB)

    Barthelemy, C.R.; Nakayama, D.A.; Lightfoot, R.W. Jr.; Wortmann, R.L.; Carrera, G.F.

    1984-01-01

    A prospective analysis of 60 patients with gout was undertaken to evaluate the radiographic spectrum of gouty arthritis in patients treated in the era of hypouricemic therapy. Twenty-two of these patients were clinically tophaceous; 36 were considered to have radiographic findings diagnostic of gouty arthritis by strict radiographic criteria. Up to 24% of the patients denied symptoms in joints with radiographic changes of gout; 42% with no evidence of tophi on clinical examination had radiographic changes characteristic of gout. Radiographic assessment can be extremely helpful in the management of gout by documenting the degree and extent of bony involvement, particularly in patients with limited symptoms or without clinical tophi.

  20. Clinical profile of 266 Filipino patients with rheumatoid arthritis included in the rheumatoid arthritis database and registry (RADAR) of the Philippine General Hospital.

    Science.gov (United States)

    Penserga, Ester G; Natividad, Therese Aileen L; Salido, Evelyn S

    2015-05-01

    To describe Filipino patients with rheumatoid arthritis (RA) entered in the Rheumatoid arthritis database and registry (RADAR) of the Philippine General Hospital. Cases entered to RADAR from 2010-2012 were included. All fulfilled the 1987 American College of Rheumatology criteria for classification of RA. Included cases gave written infomed consent. Data extracted were demographics, clinical presentation, laboratory tests, treatment and disease course. Means and proportions were used for population characteristics. Two hundred and sixty-six cases were included. Mean age was 44 years, with 9 : 1 female preponderance and mean diagnosis time of 5 years. There was symmetrical polyarthritis with high tender and swollen joint count and mean Disease Activity Score of 28 joints, erythrocyte sedimentation rate of 5.27 (3.39, 8.13). Rheumatoid factor was positive in 2/3 of cases. Hypertension, tuberculosis and diabetes were important co-morbidities. Treatment included prednisone, non-steroidal anti-inflammatory drugs and methotrexate. At 12 months of treatment, evaluable cases (arthritis unit whose disease characteristics are similar to what is reported worldwide. This cohort differs from most studies in having a high female to male ratio, a long delay in diagnosis, and high attrition rate. Mean methotrexate dose was low and there was less access to biologic disease-modifying anti-rheumatic drugs. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  1. Slowing of bone loss in patients with rheumatoid arthritis by long-term high-intensity exercise: results of a randomized, controlled trial.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Lems, W.F.; Zwinderman, A.H.; Kroon, H.M.; Pauwels, E.K.; Jansen, A.; Ronday, K.H.; Dijkmans, B.A.C.; Breedveld, F.C.; Vliet Vlieland, T.P.M.; Hazes, J.M.W.

    2004-01-01

    OBJECTIVE: Patients with rheumatoid arthritis (RA) are more at risk for the development of osteoporosis and osteoporotic fractures than are their healthy peers. In this randomized, controlled, multicenter trial, the effectiveness of a 2-year high-intensity weight-bearing exercise program (the Rheuma

  2. Lack of effect of doxycycline on disease activity and joint damage in patients with rheumatoid arthritis. A double blind, placebo controlled trial

    NARCIS (Netherlands)

    Laan, W. van der; Molenaar, E.; Ronday, K.; Verheijen, J.; Breedveld, F.; Greenwald, R.; Dijkmans, B.; Tekoppele, J.

    2001-01-01

    Objective. To investigate the effects of doxycycline on disease activity and joint destruction in patients with rheumatoid arthritis (RA). Methods. A 36 week double blind, placebo controlled crossover trial was conducted. Patients (n = 66) received 50 mg doxycycline or placebo twice a day during 12,

  3. Spiritual Healing in the Treatment of Rheumatoid Arthritis: An Exploratory Single Centre, Parallel-Group, Double-Blind, Three-Arm, Randomised, Sham-Controlled Trial

    DEFF Research Database (Denmark)

    Bliddal, H.; Christensen, Robin Daniel Kjersgaard; Hojgaard, L.

    2014-01-01

    Our objective was to investigate the efficacy of "energy/spiritual healing" in rheumatoid arthritis (RA). Eligible patients were women with RA on stable medication. The design was a randomised, blinded, sham-controlled trial; the third group included an external unblinded control of the natural c...

  4. Hand bone loss in early rheumatoid arthritis during a methotrexate-based treat-to-target strategy with or without adalimumab-a substudy of the optimized treatment algorithm in early RA (OPERA) trial

    DEFF Research Database (Denmark)

    Ørnbjerg, L M; Østergaard, M; Jensen, T

    2017-01-01

    This study aims to investigate 1-year hand bone loss (HBL1-year) in early rheumatoid arthritis (RA) patients treated with a methotrexate (MTX) and intra-articular triamcinolone treat-to-target strategy +/- adalimumab and to determine if HBL6months is associated with radiographic progression after 2...... years. In a clinical trial (OPERA) of 180 treatment-naive early RA patients, bone mineral density (BMD) was estimated from hand radiographs with digital X-ray radiogrammetry (DXR) at baseline, after 6 (n = 90) and 12 months (n = 70) of follow-up. Baseline and 2-year radiographs were scored according...

  5. Clinical Trials: A Crucial Key to Human Health Research

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...

  6. Laboratory research at the clinical trials of Veterinary medicinal Products

    OpenAIRE

    ZHYLA M.I.

    2011-01-01

    The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.

  7. Metaanalysis vs large clinical trials: which should guide our management?

    Science.gov (United States)

    Scifres, Christina M; Iams, Jay D; Klebanoff, Mark; Macones, George A

    2009-05-01

    Large, randomized clinical trials have long been considered the gold standard to guide clinical care. Metaanalysis is a type of analysis in which results of a number of randomized clinical trials are combined and a summary measure of effect for a given treatment is ascertained. The clinician in practice often is faced with a dilemma regarding the type of evidence that should be used to guide clinical practice; for many clinical problems, there are both randomized controlled trials and metaanalyses available. The cases of calcium and aspirin therapy for the prevention of preeclampsia afford an opportunity to explore the benefits and limitations of each type of study to guide clinical practice. We conclude that, when available, large randomized clinical trials should be used to guide clinical practice.

  8. Compliance with results reporting at ClinicalTrials.gov.

    Science.gov (United States)

    Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James; Califf, Robert M

    2015-03-12

    The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results. Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions. Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic

  9. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND:Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS......:We conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two......%). Heterogeneity was moderate (I(2) = 46%, p = 0.02) and unexplained by metaregression. INTERPRETATION:We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk...

  10. Simulating Clinical Trials With and Without Intracranial EEG Data.

    Science.gov (United States)

    Goldenholz, Daniel M; Tharayil, Joseph J; Kuzniecky, Rubin; Karoly, Philippa; Theodore, William H; Cook, Mark J

    2017-06-01

    It is currently unknown if knowledge of clinically silent (electrographic) seizures improves the statistical efficiency of clinical trials. Using data obtained from 10 patients with chronically implanted subdural electrodes over an average of 1 year, a Monte Carlo bootstrapping simulation study was performed to estimate the statistical power of running a clinical trial based on A) patient reported seizures with intracranial EEG (icEEG) confirmation, B) all patient reported events, or C) all icEEG confirmed seizures. A "drug" was modeled as having 10%, 20%, 30%, 40% and 50% efficacy in 1000 simulated trials each. Outcomes were represented as percentage of trials that achieved pseizures (pseizure detection using chronically implanted icEEG improves statistical power of clinical trials. Newer invasive and noninvasive seizure detection devices may have the potential to provide greater statistical efficiency, accelerate drug discovery and lower trial costs.

  11. Phases I–III Clinical Trials Using Adult Stem Cells

    Directory of Open Access Journals (Sweden)

    Ricardo Sanz-Ruiz

    2010-01-01

    Full Text Available First randomized clinical trials have demonstrated that stem cell therapy can improve cardiac recovery after the acute phase of myocardial ischemia and in patients with chronic ischemic heart disease. Nevertheless, some trials have shown that conflicting results and uncertainties remain in the case of mechanisms of action and possible ways to improve clinical impact of stem cells in cardiac repair. In this paper we will examine the evidence available, analyze the main phase I and II randomized clinical trials and their limitations, discuss the key points in the design of future trials, and depict new directions of research in this fascinating field.

  12. Unfulfilled translation opportunities in industry sponsored clinical trials

    DEFF Research Database (Denmark)

    Smed, Marie; Getz, Kenneth A.

    2013-01-01

    in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract...... knowledge gained by physicians in the process of clinical trials. These restrictions to knowledge-transfer between site and sponsor are further challenged if CRO partners are integrated in the trial process. © 2013 Elsevier Inc. All rights reserved....

  13. Arthritis - resources

    Science.gov (United States)

    Resources - arthritis ... The following organizations provide more information on arthritis : American Academy of Orthopaedic Surgeons -- orthoinfo.aaos.org/menus/arthritis.cfm Arthritis Foundation -- www.arthritis.org Centers for Disease Control and Prevention -- www. ...

  14. A CLINICAL STUDY ON AJMODADI CHURNA AND ERANDA TAILA IN THE MANAGEMENT OF AMAVATA (RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    Mishra Pramod Kumar

    2013-06-01

    Full Text Available Despite amazing diagnostic techniques and medicines, our society is suffering from unpreventable epidemics of heart diseases, cancers, rheumatoid diseases and other autoimmune diseases. Amavata is a crippling disease caused due to ama. In this disease, doshas get mingled with ama and take seat of kapha specially joints causing swelling, pain and stiffness there. In modern system of medicine its very clinical correlate is rheumatoid arthritis, an autoimmune inflammatory disease. In spite of superb anti inflammatory and immunosuppressive drugs and biological agents it is very difficult to cure rheumatoid arthritis completely. These drugs have various multi system side effect on prolong use. On the contrary, Ayurvedic medicines have minimal or no side effects on long term use and there is improvement in quality of life as well. In present study 17 patients were selected randomly from OPD and IPD of Sir Sundar Lal Hospital, BHU, Varanasi, India to study the effect of Ajmodadi churna and Eranda taila. There was quite improvement in the symptoms and not any side effect was observed as such.

  15. Characterization of rheumatoid arthritis subtypes using symptom profiles, clinical chemistry and metabolomics measurements.

    Directory of Open Access Journals (Sweden)

    Herman A van Wietmarschen

    Full Text Available OBJECTIVE: The aim is to characterize subgroups or phenotypes of rheumatoid arthritis (RA patients using a systems biology approach. The discovery of subtypes of rheumatoid arthritis patients is an essential research area for the improvement of response to therapy and the development of personalized medicine strategies. METHODS: In this study, 39 RA patients are phenotyped using clinical chemistry measurements, urine and plasma metabolomics analysis and symptom profiles. In addition, a Chinese medicine expert classified each RA patient as a Cold or Heat type according to Chinese medicine theory. Multivariate data analysis techniques are employed to detect and validate biochemical and symptom relationships with the classification. RESULTS: The questionnaire items 'Red joints', 'Swollen joints', 'Warm joints' suggest differences in the level of inflammation between the groups although c-reactive protein (CRP and rheumatoid factor (RHF levels were equal. Multivariate analysis of the urine metabolomics data revealed that the levels of 11 acylcarnitines were lower in the Cold RA than in the Heat RA patients, suggesting differences in muscle breakdown. Additionally, higher dehydroepiandrosterone sulfate (DHEAS levels in Heat patients compared to Cold patients were found suggesting that the Cold RA group has a more suppressed hypothalamic-pituitary-adrenal (HPA axis function. CONCLUSION: Significant and relevant biochemical differences are found between Cold and Heat RA patients. Differences in immune function, HPA axis involvement and muscle breakdown point towards opportunities to tailor disease management strategies to each of the subgroups RA patient.

  16. Low vaccination rates among patients with rheumatoid arthritis in a German outpatient clinic.

    Science.gov (United States)

    Krasselt, Marco; Ivanov, Jean-Philipp; Baerwald, Christoph; Seifert, Olga

    2017-02-01

    Patients with rheumatoid arthritis (RA) are at an increased risk of acquiring infections due to two reasons: the disease itself and the immunosuppressive therapy. Vaccinations against preventable diseases are therefore of utmost importance for these group of patients. To estimate vaccination frequencies among patients with rheumatoid arthritis, we studied patients in a survey and calculated vaccination rates based on their vaccination documents. Patients have been recruited from our outpatient clinic during one of their routine visits. For the statistical analysis, they have been divided by age (≥60 vs vaccination rates, in particular for the strongly recommended vaccines against Pneumococcus and Influenza (33 and 53%, respectively). Furthermore, protection rates for important basic vaccinations, e.g. against Pertussis, were found to be very low with 12% only. Beside these findings, we saw age-dependent differences for a variety of vaccines: while Pneumococcus and Influenza vaccines were more often given to patients ≥60 years, MMR, Pertussis, Diphtheria and Hepatitis were significantly more often applied to younger patients. Vaccination rates have to be improved among RA patients, in particular for vaccines protecting from respiratory tract infections such as Pneumococcus.

  17. A REVIEW ON CLINICAL TRIALS: WHY TO INTRODUCE ZERO PHASE

    OpenAIRE

    MANINDER KAUR; AMRITPAL SINGH

    2016-01-01

    Objective: The main objective of this study is to know clinical trials in nutshell and phase 0 clinical trial are to establish at the very earliest opportunity-before large numbers of patients have been accrued and exposed to potential drug-associated toxicity-whether an agent is modulating its target in a tumor, and consequently whether further clinical development is warranted. We review here the fundamental requirements of clinical studies conducted under an exploratory IND and address som...

  18. Inability of positive phase II clinical trials of investigational treatments to subsequently predict positive phase III clinical trials in glioblastoma.

    Science.gov (United States)

    Mandel, Jacob J; Yust-Katz, Shlomit; Patel, Akash J; Cachia, David; Liu, Diane; Park, Minjeong; Yuan, Ying; A Kent, Thomas; de Groot, John F

    2017-07-31

    Glioblastoma is the most common primary malignant brain tumor in adults, but effective therapies are lacking. With the scarcity of positive phase III trials, which are increasing in cost, we examined the ability of positive phase II trials to predict statistically significant improvement in clinical outcomes of phase III trials. A PubMed search was conducted to identify phase III clinical trials performed in the past 25 years for patients with newly diagnosed or recurrent glioblastoma. Trials were excluded if they did not examine an investigational chemotherapy or agent, if they were stopped early owing to toxicity, if they lacked prior phase II studies, or if a prior phase II study was negative. Seven phase III clinical trials in newly diagnosed glioblastoma and 4 phase III clinical trials in recurrent glioblastoma met the inclusion criteria. Only 1 (9%) phase III study documented an improvement in overall survival and changed the standard of care. The high failure rate of phase III trials demonstrates the urgent need to increase the reliability of phase II trials of treatments for glioblastoma. Strategies such as the use of adaptive trial designs, Bayesian statistics, biomarkers, volumetric imaging, and mathematical modeling warrant testing. Additionally, it is critical to increase our expectations of phase II trials so that positive findings increase the probability that a phase III trial will be successful.

  19. Facilitating recruitment of patients with schizophrenia to a clinical trial

    DEFF Research Database (Denmark)

    Grønbech, Bettina Ellen

    People with severe mental illness, such as schizophrenia have higher rates of mortality especially due to cardiovascular disease. We have established a clinical trial named “Coronary artery disease and schizophrenia”. However, patients with schizophrenia have cognitive disturbances, which make re...... recruitment of patients challenging. The purpose of this study is to understand which type of recruitment strategy is needed in clinical trials....

  20. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  1. Review on clinical trials of targeted treatments in malignant mesothelioma

    DEFF Research Database (Denmark)

    Jakobsen, Jan Nyrop; Sørensen, Jens Benn

    2011-01-01

    Malignant mesothelioma (MM) is an aggressive tumor of the serosal surfaces with a poor prognosis. Advances in the understanding of tumor biology have led to the development of several targeted treatments, which have been evaluated in clinical trials. This article is a comprehensive review of all...... clinical trials evaluating the effect of targeted treatments in MM....

  2. Perspectives on randomized clinical trials : the case for albuminuria

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo Jan

    2008-01-01

    Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious random

  3. Future vision for the quality assurance of oncology clinical trials

    Directory of Open Access Journals (Sweden)

    Thomas eFitzGerald, MD

    2013-03-01

    Full Text Available The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.

  4. Implementation of the NCI’s National Clinical Trials Network

    Science.gov (United States)

    NCI is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year. The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initia

  5. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  6. The application of disease management to clinical trial designs.

    Science.gov (United States)

    Puterman, Jared; Alter, David A

    2009-08-01

    The utilization of disease management (DM) as a minimum standard of care is believed to facilitate pronounced benefits in overall patient outcome and cost management. Randomized clinical trials remain the gold standard evaluative tool in clinical medicine. However, the extent to which contemporary cardiovascular clinical trials incorporate DM components into their treatment or control arms is unknown. Our study is the first to evaluate the extent to which clinical trials incorporate DM as a minimum standard of care for both the intervention and control groups. In total, 386 clinical trials published in 3 leading medical journals between 2003 and 2006 were evaluated. For each study, elements related to DM care, as defined using the American Heart Association Taxonomy, were abstracted and characterized. Our results demonstrate that while the application of DM has increased over time, only 3.4% of the clinical trials examined incorporated all 8 DM elements (and only 11% of such trials incorporated 4 DM elements). A significant association was found between study year and the inclusion of more than 3 elements of DM (chi(2) = 10.10 (3); p = 0.018). In addition, associations were found between study objective and DM criteria, as well as between cohort type and domains described. Our study serves as a baseline reference for the tracking of DM within, and its application to, randomized clinical trials. Moreover, our results underscore the need for broader implementation and evaluation of DM as a minimum care standard within clinical trial research.

  7. The Pharmacodynamic Impact of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, on Circulating Levels of Inflammatory Biomarkers in Patients with Psoriatic Arthritis: Substudy Results from a Phase III, Randomized, Placebo-Controlled Trial (PALACE 1

    Directory of Open Access Journals (Sweden)

    Peter H. Schafer

    2015-01-01

    Full Text Available Apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated effectiveness (versus placebo for treatment of active psoriatic arthritis in the psoriatic arthritis long-term assessment of clinical efficacy (PALACE phase III clinical trial program. Pharmacodynamic effects of apremilast on plasma biomarkers associated with inflammation were evaluated in a PALACE 1 substudy. Of 504 patients randomized in PALACE 1, 150 (placebo: n=51; apremilast 20 mg BID: n=51; apremilast 30 mg BID: n=48 provided peripheral blood plasma samples for analysis in a multiplexed cytometric bead array assay measuring 47 proteins associated with systemic inflammatory immune responses. Association between biomarker levels and achievement of 20% improvement from baseline in modified American College of Rheumatology (ACR20 response criteria was assessed by logistic regression. At Week 24, IL-8, TNF-α, IL-6, MIP-1β, MCP-1, and ferritin were significantly reduced from baseline with apremilast 20 mg BID or 30 mg BID versus placebo. ACR20 response correlated with change in TNF-α level with both apremilast doses. At Week 40, IL-17, IL-23, IL-6, and ferritin were significantly decreased and IL-10 and IL-1 receptor antagonists significantly increased with apremilast 30 mg BID versus placebo. In patients with active psoriatic arthritis, apremilast reduced circulating levels of Th1 and Th17 proinflammatory mediators and increased anti-inflammatory mediators.

  8. Incorporation of n-3 PUFA and γ-linolenic acid in blood lipids and red blood cell lipids together with their influence on disease activity in patients with chronic inflammatory arthritis - a randomized controlled human intervention trial

    Directory of Open Access Journals (Sweden)

    Springer Monika

    2011-08-01

    Full Text Available Abstract Background and aim Marine n-3 fatty acids and γ-linolenic acid both have anti-inflammatory effects and may be useful to help treat inflammatory diseases. The effects of these alone or combined were examined in patients with arthritis in a randomized controlled trial. Design Patients with rheumatoid arthritis or psoriatic arthritis were randomized into four groups in a double-blind, placebo-controlled parallel designed study. Patients received the respective capsules (1: 3.0 g n-3 LC-PUFA/d; 2: 3.2 g γ-linolenic acid/d; 3: 1.6 g n-3 LC-PUFA + 1.8 g γ-linolenic acid/d; 4: 3.0 g olive oil for a twelve week period. Clinical status was evaluated and blood samples were taken at the beginning and at the end of the period. Differences before and after intervention were tested with paired t-test or with Wilcoxon test for non-normal data distribution. Results 60 patients (54 rheumatoid arthritis, 6 psoriatic arthritis were randomised, 47 finished per protocol. In group 1, the ratio of arachidonic acid (AA/eicosapentaenoic acid (EPA decreased from 6.5 ± 3.7 to 2.7 ± 2.1 in plasma lipids and from 25.1 ± 10.1 to 7.2 ± 4.7 in erythrocyte membranes (p ≤ 0.001. There was no significant influence on AA/EPA ratio due to interventions in group 2-4. In group 2, the intake of γ-linolenic acid resulted in a strong rise of γ-linolenic acid and dihomo-γ-linolenic acid concentrations in plasma lipids, cholesteryl esters, and erythrocyte membranes. The combination of n-3 LC-PUFA and γ-linolenic acid (group 3 led to an increase of γ-linolenic acid and dihomo-γ-linolenic acid concentrations in plasma lipids, cholesteryl esters, and erythrocyte mem-branes. This increase was only half of that in group 2. Conclusions Incorporation of eicosanoid precursor FAs was influenced by an intake of n-3 LC-PUFA and γ-linolenic acid suggesting a possible benefit for therapy of chronic inflammatory diseases. Trial Registration ClinicalTrials NCT01179971

  9. Randomized and Controlled Clinical Study of Modified Prescriptions of Simiao Pill(四妙丸) in the Treatment of Acute Gouty Arthritis

    Institute of Scientific and Technical Information of China (English)

    SHI Xin-de; LI Guo-chun; QIAN Zu-xi; JIN Ze-qiu; SONG Yan

    2008-01-01

    Objective: To investigate the compatibility of a modified prescription of Simiao Pill (四妙丸) in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial. Methods: A randomized and controlled clinical trial was designed based on clinical epidemiological principles, A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group Ⅰ) included 27 patients taking gout prescription Ⅰ ; the second group (Group Ⅱ) included 27 patients taking gout prescription Ⅱ ; the third group (Group Ⅲ) included 28 patients taking gout prescription Ⅲ; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment, the index of blood uric acid, blood leukocyte count, score of clinical symptoms, etc. were observed and measured. Results: The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%,significantly superior to that of the control group (68%, P<0.05). In terms of the improvement of main symptoms, the scores of four symptoms in all TCM treatment and control groups decreased after treatment, with statistically significant differences (P<0.05). Moreover, the scores markedly fell more so in the three Chinese herb groups than in the control group, and especially in Group Ⅲ (P<0.05). There was a statistically significant difference in blood uric acid values before and after the treatment in the same group but no significant inter-group difference was seen. Conclusion: The modified prescriptions, based on the clinical research, clinical experience and traditional Chinese medicine theory, did show a better effect than Western medicine in this clinical study. Moreover, the prescriptions were precise, with the herbs inexpensive and readily available. The

  10. Gene therapy clinical trials worldwide to 2012 - an update.

    Science.gov (United States)

    Ginn, Samantha L; Alexander, Ian E; Edelstein, Michael L; Abedi, Mohammad R; Wixon, Jo

    2013-02-01

    To date, over 1800 gene therapy clinical trials have been completed, are ongoing or have been approved worldwide. Our database brings together global information on gene therapy clinical trials from official agency sources, published literature, conference presentations and posters kindly provided to us by individual investigators or trial sponsors. This review presents our analysis of clinical trials that, to the best of our knowledge, have been or are being performed worldwide. As of our June 2012 update, we have entries on 1843 trials undertaken in 31 countries. We have analysed the geographical distribution of trials, the disease indications (or other reasons) for trials, the proportions to which different vector types are used, and which genes have been transferred. Details of the analyses presented, and our searchable database are available on The Journal of Gene Medicine Gene Therapy Clinical Trials Worldwide website at: http://www.wiley.co.uk/genmed/clinical. We also provide an overview of the progress being made in clinical trials of gene therapy approaches around the world and discuss the prospects for the future.

  11. Adult cancer clinical trials that fail to complete: an epidemic?

    Science.gov (United States)

    Stensland, Kristian D; McBride, Russell B; Latif, Asma; Wisnivesky, Juan; Hendricks, Ryan; Roper, Nitin; Boffetta, Paolo; Hall, Simon J; Oh, William K; Galsky, Matthew D

    2014-09-01

    The number and diversity of cancer therapeutics in the pipeline has increased over the past decade due to an enhanced understanding of cancer biology and the identification of novel therapeutic targets. At the same time, the cost of bringing new drugs to market and the regulatory burdens associated with clinical drug development have progressively increased. The finite number of eligible patients and limited financial resources available to evaluate promising new therapeutics represent rate-limiting factors in the effort to translate preclinical discoveries into the next generation of standard therapeutic approaches. Optimal use of resources requires understanding and ultimately addressing inefficiencies in the cancer clinical trials system. Prior analyses have demonstrated that a large proportion of trials initiated by the National Cancer Institute (NCI) Cooperative Group system are never completed. While NCI Cooperative Group trials are important, they represent only a small proportion of all cancer clinical trials performed. Herein, we explore the problem of cancer clinical trials that fail to complete within the broader cancer clinical trials enterprise. Among 7776 phase II-III adult cancer clinical trials initiated between 2005-2011, we found a seven-year cumulative incidence of failure to complete of approximately 20% (95% confidence interval = 18% to 22%). Nearly 48000 patients were enrolled in trials that failed to complete. These trials likely contribute little to the scientific knowledge base, divert resources and patients from answering other critical questions, and represent a barrier to progress.

  12. Placebos used in clinical trials for Chinese herbal medicine.

    Science.gov (United States)

    Qi, Guan D; We, Ding A; Chung, Leung P; Fai, Cheng K

    2008-06-01

    One of the important components in randomized Controlled Trial (RCT) is blinding. The gold standard of clinical trials is to achieve a double blind design. However, only a small number of randomized controlled trials in traditional Chinese medicine have been reported, most of them are of poor quality in methodology including placebo preparation and verification. The purpose of the article is to review the validity of placebo used in blinded clinical trials for Chinese herbal medicine (CHM) in recent years and related patents. We searched the Wanfang Database (total of 827 Chinese journals of medicine and/or pharmacy, from 1999 to 2005) and 598 full-length articles related to placebo clinical trials were found. 77 placebo blinded clinical trials for Chinese medicine were extracted by manual search from the 598 articles. After reviewing the 77 full-length articles, we found that nearly half of the clinical trials did not pay attention to the physical quality of the testing drug and placebo and whether they were of comparable physical quality. The rest provided very limited placebo information so that blinding assurance could not be assumed. Only 2 articles (2.6%) specifically validated the comparability between the testing drug and the placebo. Researchers in Chinese medicine commonly ignored the quality of the placebo in comparison to the test drug. This may be causing bias in the clinical trials. Quality specifications and evaluation of the placebo should deserve special attention to reduce bias in randomized controlled trials in TCM study.

  13. Efficiency and safety of leflunomide in rheumatoid arthritis: Results of a Russian observational multicenter of trial

    Directory of Open Access Journals (Sweden)

    R. M. Balabanova

    2015-01-01

    Full Text Available Methotrexate or leflunomide is used as a first-line synthetic disease-modifying anti-rheumatic drug in the therapy of rheumatoid arthritis (RA. In 2011, the Russian Federation registered and since it has been successfully using leflunomide**.Objective: to evaluate the efficacy and tolerability of leflunomide** used to treat RA in routine clinical practice.Subjects and methods.The investigation enrolled patients with varying duration of RA that met the 1987 classification criteria. The patients were followed up in 33 healthcare facilities of Russia from March 2013 to October 2014. A total of 235 patients were randomized; the data of 196 patients were statistically processed. The mean age of the patients was 52.4±11.8 years; the mean duration of the disease was 75.4±69.1 months. The disease activity estimated by DAS28 and CDAI were 5.5±1.2 and 35.1±14.3 scores, respectively. 105 and 57 patients had X-ray Stages II and III disease, respectively. 80.1% of the patients were positive for rheumatoid factor and anti-cyclic citrullinated peptide antibodies. According to the instruction of its use, leflunomide was administered in a dose of 100 mg/day during the first 3 days and then in that of 20 mg/day. When adverse reactions (ARs occurred, it was recommended that the daily dose of the drug was decreased to 10 mg. The patients were examined before and 1, 3, and 6 months after treatment. The investigators measured the number of tender joints (NTJ and that of swollen joints (NSJ, and visual analog scale (VAS pain intensity, performed a laboratory examination involving clinical blood test, erythrocyte sedimentation rate (ESR, and C-reactive protein (CRP, in patients during their visits to physicians. The disease activity was assessed with DAS28 and CDAI and ARs were recorded.Results. Six-month therapy reduced the mean NSJ from 10.9 to 7.5%, NTJ from 12.3 to 8.9, VAS pain intensity from 64.1 to 39.3 mm, on average, ESR from 37.04 to 23.6 mm/hr, and

  14. QUEST-RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries

    DEFF Research Database (Denmark)

    Sokka, Tuulikki; Kautiainen, Hannu; Toloza, Sergio

    2007-01-01

    OBJECTIVE: To conduct a cross-sectional review of non-selected consecutive outpatients with rheumatoid arthritis (RA) as part of standard clinical care in 15 countries for an overview of the characteristics of patients with RA. METHODS: The review included current disease activity using data from...

  15. Most Trial Eligibility Criteria and Patient Baseline Characteristics Do Not Modify Treatment Effect in Trials Using Targeted Therapies for Rheumatoid Arthritis: A Meta-Epidemiological Study.

    Directory of Open Access Journals (Sweden)

    Anton Wulf Christensen

    Full Text Available To determine if variations in trial eligibility criteria and patient baseline characteristics could be considered effect modifiers of the treatment response when testing targeted therapies (biological agents and targeted synthetic disease modifying antirheumatic drugs (DMARDs for rheumatoid arthritis (RA.We conducted a meta-epidemiological study of all trials evaluating a targeted therapy approved by regulatory authorities for treating RA. The database search was completed on December 11th 2013. Eligible trials reported ACR20 data at months 3-6 and used an add-on design. Odds ratios (ORs were calculated from the response rates and compared among the trial eligibility criteria/patient baseline characteristics of interest. Comparisons are presented as the Ratio of Odds Ratios (ROR.Sixty-two trials (19,923 RA patients were included in the primary analyses using ACR20 response. Overall, targeted therapies constituted an effective treatment (OR 3.96 95% confidence interval (CI 3.41 to 4.60. The majority of the trial eligibility criteria and patient baseline characteristics did not modify treatment effect. The added benefit of targeted therapies was lower in trials including "DMARD-naïve" patients compared with trials including "DMARD inadequate responders" (ROR = 0.45, 95%CI 0.31 to 0.66 and trials including "targeted therapy inadequate responders" (0.50, 95%CI 0.29 to 0.87, test for interaction: p = 0.0002. Longer mean disease duration was associated with a higher likelihood of responding to treatment (β = 1.05, 95%CI 1.00 to 1.11 OR's per year; p = 0.03. Analyses conducted using DAS28-remission as the outcome supported the above-mentioned findings.Our results suggest that a highly selective inclusion is not associated with greater treatment effect, as might otherwise be expected. The added benefit of a targeted therapy was lower in trials including patients who were DMARD-naïve and trials including patients with shorter disease durations.

  16. [Multi-national clinical trial in circulatory disorders].

    Science.gov (United States)

    Takahashi, Kihito

    2009-02-01

    As Japan becomes more integrated into the global market, pharmaceutical research and development (R&D) in Japan faces considerable challenges. While global simultaneous development including Asian countries has become a common strategy for multi-national pharmaceutical companies, Japan has been frequently set aside because of its provincial regulatory and clinical trial infrastructure. Meanwhile, many improvement programs in pharmaceutical area have been initiated in Japan. With this increased scrutiny, significant improvements in regulatory process, clinical trial costs, and site performance are anticipated over the next few years. RENAAL is the first multi-national clinical trial involving Japanese patients diabetic nephropathy associated with type II diabetes mellitus. In this article, issues which have been observed in the process of conducting multi-national clinical trial were discussed based on the experience with RENAAL. It is hoped that, as we gain more experiences in multi-national clinical trials, solutions for these issues are found in near future.

  17. Towards a framework of success factors for clinical trials

    DEFF Research Database (Denmark)

    Buonansegna, Erika; Salomo, Søren; Maier, Anja

    2012-01-01

    Clinical trials in the pharmaceutical industry are the most critical part of the drug development process with respect to obtaining the market approval from the authorities. Clinical trials are highly expensive, time-consuming and often unsuccessful. While new product development (NPD) literature...... clinical trials reducing failures and increasing profits. The framework directs managerial focus on the most important factors for success and helps managers in decision-making of operational tasks. The framework can also be applied as a checklist for assessing the status of a clinical trial and later...... as a benchmarking tool to compare clinical trial processes. Dependencies among the identified factors seem to exist, thus a set of propositions, can be developed from the success factors and be the basis for future empirical testing....

  18. Towards a framework of success factors for clinical trials

    DEFF Research Database (Denmark)

    Buonansegna, Erika; Salomo, Søren; Maier, Anja

    2012-01-01

    of success factors. This paper creates the new framework by combining success factors from NPD literature and from empirical evidence collected through 11 semi-structured interviews with experts in clinical trials. The framework of success factors provides managerial guidelines for practitioners to optimize...... clinical trials reducing failures and increasing profits. The framework directs managerial focus on the most important factors for success and helps managers in decision-making of operational tasks. The framework can also be applied as a checklist for assessing the status of a clinical trial and later......Clinical trials in the pharmaceutical industry are the most critical part of the drug development process with respect to obtaining the market approval from the authorities. Clinical trials are highly expensive, time-consuming and often unsuccessful. While new product development (NPD) literature...

  19. Clinical Trial: Marine Lipid Suppositories as Laxatives

    Science.gov (United States)

    Ormarsson, Orri Thor; Geirsson, Thormodur; Bjornsson, Einar Stefan; Jonsson, Tomas; Moller, Pall; Loftsson, Thorsteinn; Stefansson, Einar

    2012-01-01

    Cod-liver oil and other marine products containing polyunsaturated fatty acids have anti-inflammatory, anti-bacterial and anti-viral effects and may be useful in the treatment of various inflammatory and infectious diseases. We developed suppositories and ointment with 30% free fatty acid (FFA) extract from omega-3 fish oil. Our purpose was to evaluate the safety of marine lipid suppositories and ointment in healthy volunteers and to explore the laxative effect of the suppositories. Thirty healthy volunteers were randomized either to a study group administrating 30% FFA suppositories and applying 30% FFA ointment to the perianal region twice per day for two weeks, or to a control group using placebo suppositories and ointment in a double blinded manner. Results: No serious toxic effects or irritation were observed. In the study group 93% felt the urge to defecate after administration of the suppositories as compared to 37% in the control group (P = 0.001). Subsequently 90% in the study group defecated, compared to 33% in the control group (P = 0.001). Conclusion: The marine lipid suppositories and ointment were well tolerated with no significant toxic side effects observed during the study period. The suppositories have a distinct laxative effect and we aim to explore this effect in further clinical trials. PMID:23118720

  20. Clinical evidence for Japanese population based on prospective studies--linking clinical trials and clinical practice.

    Science.gov (United States)

    Ogawa, Hisao; Kojima, Sunao

    2009-10-01

    "Evidence-based medicine (EBM)" implies effective and high quality practice for patients based on well-grounded medical science. The success of clinical trials in Japan is essential to build original evidence specific for Japanese patients. Based on this concept, we have performed several large-scale clinical trials to provide EBM, including the Japanese Antiplatelets Myocardial Infarction Study [JAMIS; clinical improvement in acute myocardial infarction (AMI) patients with antiplatelet therapy], the Japanese beta-Blockers and Calcium Antagonists Myocardial Infarction (JBCMI; comparison of the effects of beta-blockers and calcium antagonists on cardiovascular events in post-AMI patients), a multicenter study for aggressive lipid-lowering strategy by HMG-CoA reductase inhibitors in patients with AMI (MUSASHI; effects of statin therapy on cardiovascular events in patients with AMI), and the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD trial; efficacy of low-dose aspirin therapy for primary prevention of atherosclerotic events in type 2 diabetic patients). The results of these prospective studies were directly linked with clinical practice. We have acquired the know-how of large-scale clinical trials; an important point is to have passion for "buildup evidence specific for the Japanese" and to recruit subjects for enrollment after explaining the significance of "clinical trials for the Japanese".