Clinical Research Support Center

Belfast, Ireland

Clinical Research Support Center

Belfast, Ireland
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Nagakura A.,Tokyo Metropolitan Childrens Medical Center | Morikawa Y.,Clinical Research Support Center | Sakakibara H.,Tokyo Metropolitan Childrens Medical Center | Miura M.,Tokyo Metropolitan Childrens Medical Center
Journal of Pediatrics | Year: 2017

Objective: To identify the prevalence of bradycardia associated with use of prednisolone in patients with Kawasaki disease and analyze the association between bradycardia and responsiveness to intravenous immunoglobulin (IVIG). Study design: We performed a retrospective cohort study of 176 patients with severe Kawasaki disease admitted to the Tokyo Metropolitan Children's Medical Center between March 2010 and December 2015. The group treated with IVIG plus prednisolone therapy from February 2012 was compared with the control group who received IVIG monotherapy before this date. The primary outcome was the prevalence of bradycardia, defined as heart rate less than the first percentile for normal children. Next, we determined whether bradycardia was associated with the clinical course in the patient subgroup treated with IVIG plus prednisolone therapy. Results: The prevalence of bradycardia was significantly higher in the IVIG plus prednisolone subgroup than in the IVIG group (79.1% vs 7.1%; P < .001). The median time to bradycardia onset was 63.0 hours (2.6 days). Prednisolone decreased the heart rate by 15.1 beats/minute (95% CI 10.2-20.0; P < .001) on average from day 2 to 7 after the initial therapy. Logistic regression analysis revealed that bradycardia was associated with responsiveness to initial IVIG plus prednisolone therapy (OR 7.2; 95% CI 2.3-23.0; P < .001). Conclusion: Bradycardia frequently occurred during IVIG plus prednisolone therapy in patients with Kawasaki disease, and was associated with responsiveness to IVIG. © 2017 Elsevier Inc.

Arakawa Y.,Clinical Research Support Center | Arakawa Y.,University of Tokyo
Yakugaku Zasshi | Year: 2013

At the University of Tokyo Hospital, investigator-driven clinical development of novel drugs and medical devices is mainly supported by the Translational Research Center and Clinical Research Support Center. The former supports non-clinical research and the preparation of test materials and the latter supports clinical trials. The Clinical Research Support Center was established in 2010 by the reorganization of the former Clinical Research Center, which was established in 2001. The center adopted International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) as a standard guideline for clinical trials and prepared standard operation procedures and templates for protocols and informed consent documents in 2001 and, thereafter, provided consultation services to researchers for protocol development. In 2010, the service was extended to project management, data management and monitoring to support the credibility of clinical trials. In 2011, The University of Tokyo Hospital was selected by the government as a base for the early and exploratory clinical development of drugs in the fields of psychological and neurological diseases. For this purpose, a phase 1 unit for early phase clinical pharmacology trials is now being built. The center provides training courses for clinical research coordinators and hold seminars for clinical researchers; however, the biggest challenge remains the education and training of medical students who will lead clinical trials in the future. © 2013 The Pharmaceutical Society of Japan.

Okada Y.,Tokyo Metropolitan Childrens Medical Center | Okada Y.,Jichi Medical University | Kumagai H.,Jichi Medical University | Morikawa Y.,Clinical Research Support Center | Akasawa A.,Tokyo Metropolitan Childrens Medical Center
Allergology International | Year: 2016

Background The Ogasawara Islands, away from mainland Japan, belong to a subtropical area. Although the daily eating habits and food are relatively similar to that on the mainland, the living environment is quite different. The prevalence of allergic diseases in the Ogasawara Islands is unknown. This study aimed to identify the prevalence of allergic diseases in the Ogasawara Islands. Methods A survey was conducted among all children belonging to preschool, elementary school, and junior high school in the Ogasawara Islands. A questionnaire was prepared in accordance with the International Study of Asthma and Allergies in Childhood (ISAAC) core written questionnaire in bronchial asthma (BA) and the West Japan Study of Asthma and Allergies in Childhood core written questionnaire for atopic dermatitis (AD), allergic rhinitis (AR), and food allergy (FA). At the same time, height, weight, duration of dwelling on the island, home environment, lifestyle, and exercise habits were also asked. Results The target population comprised 352 children, of whom 284 (80.6%) completed the questionnaires. The current prevalence was 9.3% for BA, 4.3% for AD, 17.8% for AR, and 3.0% for FA. Significantly lower rates of current BA and AD were observed compared to previous reports from Japan. The percentage of children belonging to sports clubs, and exercising more than 3 times per week at the Ogasawara Islands is higher compared with the national average. Conclusions The lower prevalence of BA and AD in the Ogasawara Islands implies the influence of differences in the living environment and exercise habits. © 2015, Japanese Society of Allergology. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license.

Stockdale J.,University of Ulster | Sinclair M.,University of Ulster | Kernohan G.,University of Ulster | McCrum-Gardner E.,Clinical Research Support Center | Keller J.,Florida State University
PLoS ONE | Year: 2013

Breastfeeding has immense public health value for mothers, babies, and society. But there is an undesirably large gap between the number of new mothers who undertake and persist in breastfeeding compared to what would be a preferred level of accomplishment. This gap is a reflection of the many obstacles, both physical and psychological, that confront new mothers. Previous research has illuminated many of these concerns, but research on this problem is limited in part by the unavailability of a research instrument that can measure the key differences between first-time mothers and experienced mothers, with regard to the challenges they face when breastfeeding and the instructional advice they require. An instrument was designed to measure motivational complexity associated with sustained breast feeding behaviour; the Breastfeeding Motivational Measurement Scale. It contains 51 self-report items (7 point Likert scale) that cluster into four categories related to perceived value of breast-feeding, confidence to succeed, factors that influence success or failure, and strength of intentions, or goal. However, this scale has not been validated in terms of its sensitivity to profile the motivation of new mothers and experienced mothers. This issue was investigated by having 202 breastfeeding mothers (100 first time mothers) fill out the scale. The analysis reported in this paper is a three factor solution consisting of value, midwife support, and expectancies for success that explained the characteristics of first time mothers as a known group. These results support the validity of the BMM scale as a diagnostic tool for research on first time mothers who are learning to breastfeed. Further research studies are required to further test the validity of the scale in additional subgroups. © 2013 Stockdale et al.

PubMed | Tohoku University, Clinical Research Support Center and Nihon University
Type: Journal Article | Journal: World journal of pediatrics : WJP | Year: 2016

The only drug approved for pervasive developmental disorders (PDD) in Japan is pimozide. Several psychotropic drugs are also prescribed for offlabel use in Japan, but details regarding their prescription and use are largely unknown. The purpose of this study was to clarify the use of drug treatment in Japanese children with PDD.Data were extracted from claims data from the Japan Medical Data Center for children younger than 18 years of age who were newly diagnosed with PDD (International Classification of Diseases version 10 codes: F84) from 2005 to 2010 (total of 3276 patients as of 2010). The prescription rates were presented as the percentage of PDD patients who were prescribed each drug.Prior to 2010, the prescription rates for atypical antipsychotics, other antipsychotics, psychostimulants, all other central nervous system drugs, anticovnvulsants, non-barbiturates, and Parkinsons disease/syndrome drugs significantly increased among the Anatomical Therapeutic Chemical classifications defined as the nervous system (trend P0.02). The prescription rate for risperidone consistently increased, reaching 6.9% in 2010 (trend P<0.0001), the highest rate of the surveyed drugs among the antipsychotics. The prescription rate for aripiprazole also increased (trend P<0.0001), reaching 1.9% in 2010. The prescription rate for pimozide showed no annual changes, with a low rate of 0.4% in 2010.Compared with pimozide, the prescription rates for risperidone, aripiprazole and other psychotropic drugs have increased. Because safety data for these drugs in Japanese children are sparse, there is a need for future safety evaluations of these drugs in Japanese children.

PubMed | Shizuoka Cancer Center, Aichi Cancer Center Hospital, Niigata Cancer Center Hospital, National Cancer Center Hospital East and 5 more.
Type: | Journal: The Annals of thoracic surgery | Year: 2016

The purpose of this study was to clarify the long-term survival outcomes after repeated lung resection (RLR) of pulmonary metastases from colorectal cancer (PM-CRC) using data from a Japanese nationwide investigation.Among 898 patients who underwent R0 resection of PM-CRC at 46 Japanese institutions between 2004 and 2008, we analyzed the data of 216 patients who experienced recurrence limited to the lung after initial resection of PM-CRC. Overall survival (OS) after RLR was analyzed, and prognostic factors were explored using a multivariate Cox analysis.Of a total 216 patients, 132 (61%) received RLR, and their 5-year OS rate was 75.3%. Twenty-two patients underwent a second RLR, and 2 patients underwent a third RLR; a favorable survival outcome was observed even after a second RLR (5-year OS rate, 55.1%). The prognostic factors associated with worse survival after RLR were concomitant liver metastasis, which had been completely resected or ablated at the initial lung metastasectomy (hazard ratio [HR], 4.84; 95% confidence interval [CI], 1.48-14.8) and location of the primary tumor in the rectum (HR, 3.16; 95% CI, 1.17-9.35). Patients without these 2 poor prognostic factors (n= 58) showed a 5-year OS rate of 82.6% after RLR.This nationwide database study showed that RLR for resectable lung-limited recurrence after PM-CRC resection could provide favorable survival, especially for patients with colon cancer without liver metastases at the initial PM-CRC resection.

Patterson S.M.,Clinical and Practice Research Group | Hughes C.M.,Clinical and Practice Research Group | Cardwell C.,Queen's University of Belfast | Lapane K.L.,Virginia Commonwealth University | And 2 more authors.
Journal of the American Geriatrics Society | Year: 2011

OBJECTIVES: To evaluate the cost-effectiveness of an adapted U.S. model of pharmaceutical care to improve psychoactive prescribing for nursing home residents in Northern Ireland (Fleetwood NI Study). DESIGN: Economic evaluation alongside a cluster randomized controlled trial. SETTING: Nursing homes in NI randomized to intervention (receipt of the adapted model of care; n=11) or control (usual care continued; n=11). PARTICIPANTS: Residents aged 65 and older who provided informed consent (N=253; 128 intervention, 125 control) and who had full resource use data at 12 months. INTERVENTION: Trained pharmacists reviewed intervention home residents' clinical and prescribing information for 12 months, applied an algorithm that guided them in assessing the appropriateness of psychoactive medication, and worked with prescribers (general practitioners) to make changes. The control homes received usual care in which there was no pharmacist intervention. MEASUREMENTS: The proportion of residents prescribed one or more inappropriate psychoactive medications (according to standardized protocols), costs, and a cost-effectiveness acceptability curve. The latter two outcomes are the focus for this article. RESULTS: The proportions of residents receiving inappropriate psychoactive medication at 12 months in the intervention and control group were 19.5% and 50.4%, respectively. The mean cost of healthcare resources used per resident per year was $4,923 (95% confidence interval (CI)=$4,206-5,640) for the intervention group and $5,053 (95% CI=$4,328-5,779) for the control group. The probability of the intervention being cost-effective was high, even at low levels of willingness to pay to avoid a resident receiving inappropriately prescribed psychoactive medication. CONCLUSION: The Fleetwood NI model of care was more cost-effective than usual care. © 2011, The American Geriatrics Society.

PubMed | Gunma Prefectural Cancer Center, Gunma University and Clinical Research Support Center
Type: Journal Article | Journal: Thoracic cancer | Year: 2016

The effects of first-line chemotherapy on overall survival (OS) might be confounded by subsequent therapies in patients with small-cell lung cancer (SCLC). Therefore, the objective of our study was to determine the relationships between progression-free survival (PFS) or post-progression survival (PPS) and OS after first-line chemotherapy in elderly patients with extensive disease-SCLC (ED-SCLC), using individual level data.Between July 1998 and December 2014, we analyzed 57 cases of elderly patients with ED-SCLC who were treated with carboplatin and etoposide as first-line chemotherapy. The relationships between PFS and PPS with OS were analyzed at an individual level.Spearman rank correlation and linear regression analyses showed that PPS was strongly correlated with OS (r=0.92, P< 0.05, R PPS has a stronger impact on OS than PFS in elderly ED-SCLC patients after first-line chemotherapy. In addition, the response at second-line treatment and the number of additional regimens after first-line treatment are significant independent prognostic factors for PPS. These results suggest that OS in elderly ED-SCLC patients may be influenced by treatments subsequent to first-line chemotherapy; however, this remains to be verified with prospective studies.

Patterson S.M.,Queen's University of Belfast | Hughes C.M.,Queen's University of Belfast | Crealey G.,Clinical Research Support Center | Cardwell C.,Queen's University of Belfast | Lapane K.L.,Virginia Commonwealth University
Journal of the American Geriatrics Society | Year: 2010

Objectives: To test the effect of an adapted U.S. model of pharmaceutical care on prescribing of inappropriate psychoactive (anxiolytic, hypnotic, and antipsychotic) medications and falls in nursing homes for older people in Northern Ireland (NI). Design: Cluster randomized controlled trial. Setting: Nursing homes randomized to intervention (receipt of the adapted model of care; n=11) or control (usual care continued; n=11). Participants: Residents aged 65 and older who provided informed consent (N=334; 173 intervention, 161 control). Intervention: Specially trained pharmacists visited intervention homes monthly for 12 months and reviewed residents' clinical and prescribing information, applied an algorithm that guided them in assessing the appropriateness of psychoactive medication, and worked with prescribers (general practitioners) to improve the prescribing of these drugs. The control homes received usual care. Measurements: The primary end point was the proportion of residents prescribed one or more inappropriate psychoactive medicine according to standardized protocols; falls were evaluated using routinely collected falls data mandated by the regulatory body for nursing homes in NI. Results: The proportion of residents taking inappropriate psychoactive medications at 12 months in the intervention homes (25/128, 19.5%) was much lower than in the control homes (62/124, 50.0%) (odds ratio=0.26, 95% confidence interval=0.14-0.49) after adjustment for clustering within homes. No differences were observed at 12 months in the falls rate between the intervention and control groups. Conclusion: Marked reductions in inappropriate psychoactive medication prescribing in residents resulted from pharmacist review of targeted medications, but there was no effect on falls. © 2009, The American Geriatrics Society.

Donaghy C.,Royal Victoria Hospital | Clarke J.,Clinical Research Support Center | Patterson C.,Queen's University of Belfast | Kee F.,Royal Victoria Hospital | And 2 more authors.
Amyotrophic Lateral Sclerosis | Year: 2010

Capture-recapture analysis allows an investigator to estimate the number of unobserved cases in an epidemiological survey, although it has not been employed widely in published research to date. This study examines the usefulness of capture-recapture analysis in measuring the incidence and prevalence of motor neuron disease (MND) in Northern Ireland (NI). Cases were ascertained from the NI MND register to measure incidence and prevalence. The authors then employed capture-recapture analysis to estimate the number of missing cases. Less than one case was estimated to be missing from the prevalence study, providing a completeness of ascertainment of 99%. Prevalence was 3.3 per 100,000 population adjusted to the European standard population and was unchanged when adjusted for missing cases. Incidence was 1.4 per 100,000 person-years adjusted to the European standard population. Due to the lack of overlapping sources it was inferred that there were no missing cases and completeness of ascertainment was estimated at 100%. In conclusion, capture-recapture analysis is relatively simple to perform and provides an objective measure of case ascertainment in epidemiological studies. The authors feel that future investigators should consider employing capture-recapture methods, where possible, to validate their estimations of disease frequency in MND. © 2010 Informa UK Ltd.

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