WorldWideScience

Sample records for syndrome study protocol

  1. Structured Wii protocol for rehabilitation of shoulder impingement syndrome: A pilot study.

    Science.gov (United States)

    Rizzo, John-Ross; Thai, Peter; Li, Edward J; Tung, Terence; Hudson, Todd E; Herrera, Joseph; Raghavan, Preeti

    2017-11-01

    To determine the feasibility and efficacy of using a structured Nintendo Wii protocol to improve range of motion, strength, and quality of life in patients with shoulder impingement syndrome. A total of 14 patients with shoulder pain were randomized to perform a structured Wii protocol (n=8) or conventional therapy (n=6). Pain-free shoulder range of motion, strength, shoulder pain and disability, and quality of life were assessed pre- and post-treatment. All 8 patients completed the Wii protocol, and 3 completed conventional therapy. The Wii protocol conferred significant improvements in shoulder range of motion, pain and disability, and quality of life but not strength, whereas conventional therapy conferred a significant improvement in strength. As compared to conventional treatment, the structured Wii protocol implemented in this pilot study was a viable adjunct to therapy for shoulder impingement syndrome. Gaming may have a supplemental benefit by increasing motivation, pleasure, and/or adherence. Further investigation in larger cohorts is warranted. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  2. Multisite Semiautomated Clinical Data Repository for Duplication 15q Syndrome: Study Protocol and Early Uses.

    Science.gov (United States)

    Ajayi, Oluwaseun Jessica; Smith, Ebony Jeannae; Viangteeravat, Teeradache; Huang, Eunice Y; Nagisetty, Naga Satya V Rao; Urraca, Nora; Lusk, Laina; Finucane, Brenda; Arkilo, Dimitrios; Young, Jennifer; Jeste, Shafali; Thibert, Ronald; Reiter, Lawrence T

    2017-10-18

    Chromosome 15q11.2-q13.1 duplication syndrome (Dup15q syndrome) is a rare disorder caused by duplications of chromosome 15q11.2-q13.1, resulting in a wide range of developmental disabilities in affected individuals. The Dup15q Alliance is an organization that provides family support and promotes research to improve the quality of life of patients living with Dup15q syndrome. Because of the low prevalence of this condition, the establishment of a single research repository would have been difficult and more time consuming without collaboration across multiple institutions. The goal of this project is to establish a national deidentified database with clinical and survey information on individuals diagnosed with Dup15q syndrome. The development of a multiclinic site repository for clinical and survey data on individuals with Dup15q syndrome was initiated and supported by the Dup15q Alliance. Using collaborative workflows, communication protocols, and stakeholder engagement tools, a comprehensive database of patient-centered information was built. We successfully established a self-report populating, centralized repository for Dup15q syndrome research. This repository also resulted in the development of standardized instruments that can be used for other studies relating to developmental disorders. By standardizing the data collection instruments, it allows us integrate our data with other national databases, such as the National Database for Autism Research. A substantial portion of the data collected from the questionnaires was facilitated through direct engagement of participants and their families. This allowed for a more complete set of information to be collected with a minimal turnaround time. We developed a repository that can efficiently be mined for shared clinical phenotypes observed at multiple clinic sites and used as a springboard for future clinical and basic research studies. ©Oluwaseun Jessica Ajayi, Ebony Jeannae Smith, Teeradache Viangteeravat

  3. A feasibility study comparing two chiropractic protocols in the treatment of patellofemoral pain syndrome.

    Science.gov (United States)

    Brantingham, James W; Globe, Gary A; Jensen, Muffit L; Cassa, Tammy K; Globe, Denise R; Price, Jennifer L; Mayer, Stephan N; Lee, Felix T

    2009-09-01

    The purpose of this pilot study was to determine the feasibility of (1) using the existing clinic, clinicians, interns, faculty, and staff from our college in conducting all components of a planned randomized controlled clinical trial; (2) successfully recruiting patients with patellofemoral pain syndrome (PFPS); and (3) consistently, effectively, and safely implementing the study protocols and therapy. Diagnostic, treatment, and blind assessment procedures were carried out while recruitment and administrative techniques for managing long-term storage of data and files were developed. Thirty-one patients were randomized into a local manipulative group (group A) or to a full kinetic chain manipulative therapy group (group B), each combined with exercise and soft tissue treatment. The Anterior Knee Pain Scale, visual analog scale, and Patient Satisfaction Scale were used. All phases of the feasibility study including use of the clinic, staff, recruitment techniques, treatment protocols, data collection, input, and analysis were effectively and safely carried out. A feasibility study investigating the ability to conduct a randomized controlled trial of a manipulative therapy protocol for PFPS using available chiropractic college infrastructure was accomplished. A fully powered PFPS trial is feasible and merited.

  4. Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bernal Daniel DL

    2012-04-01

    Full Text Available Abstract Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible

  5. Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome

    Directory of Open Access Journals (Sweden)

    Sternlieb Beth

    2011-01-01

    Full Text Available Abstract Introduction Irritable bowel syndrome affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms that can significantly impact quality of life and daily functioning. Emotional stress appears to exacerbate irritable bowel syndrome symptoms suggesting that mind-body interventions reducing arousal may prove beneficial. For many sufferers, symptoms can be traced to childhood and adolescence, making the early manifestation of irritable bowel syndrome important to understand. The current study will focus on young people aged 14-26 years with irritable bowel syndrome. The study will test the potential benefits of Iyengar yoga on clinical symptoms, psychospiritual functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and spiritual benefits to practitioners and has been associated with reduced stress and pain. Through its focus on restoration and use of props, Iyengar yoga is especially designed to decrease arousal and promote psychospiritual resources in physically compromised individuals. An extensive and standardized teacher-training program support Iyengar yoga's reliability and safety. It is hypothesized that yoga will be feasible with less than 20% attrition; and the yoga group will demonstrate significantly improved outcomes compared to controls, with physiological and psychospiritual mechanisms contributing to improvements. Methods/Design Sixty irritable bowel syndrome patients aged 14-26 will be randomly assigned to a standardized 6-week twice weekly Iyengar yoga group-based program or a wait-list usual care control group. The groups will be compared on the primary clinical outcomes of irritable bowel syndrome symptoms, quality of life and global improvement at post-treatment and 2-month follow-up. Secondary outcomes will include visceral pain sensitivity assessed with a standardized

  6. Measurements of Corneal Thickness in Eyes with Pseudoexfoliation Syndrome: Comparative Study of Different Image Processing Protocols

    Directory of Open Access Journals (Sweden)

    Katarzyna Krysik

    2017-01-01

    Full Text Available Purpose. Comparative analysis of central and peripheral corneal thickness in PEX patients using three different imaging systems: Pentacam-Scheimpflug device, time-domain optical coherence tomography (OCT Visante, and swept-source OCT Casia. Materials and Methods. 128 eyes of 80 patients with diagnosed PEX were examined and compared with 112 normal, non-PEX eyes of 72 cataract patients. The study parameters included 5 measured zones: central and 4 peripheral (superior, inferior, nasal, and temporal. Results. The mean CCT in eyes with PEX syndrome measured with all three instruments was thicker than that in normal eyes. Corneal thickness measurements in the PEX group were statistically significantly different between Pentacam and OCT Casia: central corneal thickness (p=0.04, inferior corneal zone (p=0.01, and nasal and temporal corneal zones (p<0.01. Between Pentacam and OCT Visante inferior, nasal and temporal corneal zones were statistically significantly different (p<0.01. Between OCT Casia and OCT Visante, there were no statistically significant differences in measured parameters values. Conclusion. The central corneal thickness in eyes with PEX syndrome measured with three different independent methods is higher than that in the non-PEX group, and despite variable peripheral corneal thickness, this one parameter is still crucial in intraocular pressure measurements.

  7. Study protocol subacromial impingement syndrome: the identification of pathophysiologic mechanisms (SISTIM

    Directory of Open Access Journals (Sweden)

    de Witte Pieter

    2011-12-01

    Full Text Available Abstract Background The Subacromial Impingement Syndrome (SIS is the most common diagnosed disorder of the shoulder in primary health care, but its aetiology is unclear. Conservative treatment regimes focus at reduction of subacromial inflammatory reactions or pathologic scapulohumeral motion patterns (intrinsic aetiology. Long-lasting symptoms are often treated with surgery, which is focused at enlarging the subacromial space by resection of the anterior part of the acromion (based on extrinsic aetiology. Despite that acromionplasty is in the top-10 of orthopaedic surgical procedures, there is no consensus on its indications and reported results are variable (successful in 48-90%. We hypothesize that the aetiology of SIS, i.e. an increase in subacromial pressure or decrease of subacromial space, is multi-factorial. SIS can be the consequence of pathologic scapulohumeral motion patterns leading to humerus cranialisation, anatomical variations of the scapula and the humerus (e.g. hooked acromion, a subacromial inflammatory reaction (e.g. due to overuse or micro-trauma, or adjoining pathology (e.g. osteoarthritis in the acromion-clavicular-joint with subacromial osteophytes. We believe patients should be treated according to their predominant etiological mechanism(s. Therefore, the objective of our study is to identify and discriminate etiological mechanisms occurring in SIS patients, in order to develop tailored diagnostic and therapeutic strategies. Methods In this cross-sectional descriptive study, applied clinical and experimental methods to identify intrinsic and extrinsic etiologic mechanisms comprise: MRI-arthrography (eligibility criteria, cuff status, 3D-segmented bony contours; 3D-motion tracking (scapulohumeral rhythm, arm range of motion, dynamic subacromial volume assessment by combining the 3D bony contours and 3D-kinematics; EMG (adductor co-activation and dynamometry instrumented shoulder radiographs during arm tasks (force and

  8. Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set.

    Science.gov (United States)

    Khalil, Asma; Perry, Helen; Duffy, James; Reed, Keith; Baschat, Ahmet; Deprest, Jan; Hecher, Kurt; Lewi, Liesbeth; Lopriore, Enrico; Oepkes, Dick

    2017-07-14

    Twin-Twin Transfusion Syndrome (TTTS) is associated with an increased risk of perinatal mortality and morbidity. Several treatment interventions have been described for TTTS, including fetoscopic laser surgery, amnioreduction, septostomy, expectant management, and pregnancy termination. Over the last decade, fetoscopic laser surgery has become the primary treatment. The literature to date reports on many different outcomes, making it difficult to compare results or combine data from individual studies, limiting the value of research to guide clinical practice. With the advent and ongoing development of new therapeutic techniques, this is more important than ever. The development and use of a core outcome set has been proposed to address these issues, prioritising outcomes important to the key stakeholders, including patients. We aim to produce, disseminate, and implement a core outcome set for TTTS. An international steering group has been established to oversee the development of this core outcome set. This group includes healthcare professionals, researchers and patients. A systematic review is planned to identify previously reported outcomes following treatment for TTTS. Following completion, the identified outcomes will be evaluated by stakeholders using an international, multi-perspective online modified Delphi method to build consensus on core outcomes. This method encourages the participants towards consensus 'core' outcomes. All key stakeholders will be invited to participate. The steering group will then hold a consensus meeting to discuss results and form a core outcome set to be introduced and measured. Once core outcomes have been agreed, the next step will be to determine how they should be measured, disseminated, and implemented within an international context. The development, dissemination, and implementation of a core outcome set in TTTS will enable its use in future clinical trials, systematic reviews and clinical practice guidelines. This is

  9. The SCIentinel study - prospective multicenter study to define the spinal cord injury-induced immune depression syndrome (SCI-IDS) - study protocol and interim feasibility data

    Science.gov (United States)

    2013-01-01

    Background Infections are the leading cause of death in the acute phase following spinal cord injury and qualify as independent risk factor for poor neurological outcome (“disease modifying factor”). The enhanced susceptibility for infections is not stringently explained by the increased risk of aspiration in tetraplegic patients, neurogenic bladder dysfunction, or by high-dose methylprednisolone treatment. Experimental and clinical pilot data suggest that spinal cord injury disrupts the balanced interplay between the central nervous system and the immune system. The primary hypothesis is that the Spinal Cord Injury-induced Immune Depression Syndrome (SCI-IDS) is 'neurogenic’ including deactivation of adaptive and innate immunity with decreased HLA-DR expression on monocytes as a key surrogate parameter. Secondary hypotheses are that the Immune Depression Syndrome is i) injury level- and ii) severity-dependent, iii) triggers transient lymphopenia, and iv) causes qualitative functional leukocyte deficits, which may endure the post-acute phase after spinal cord injury. Methods/Design SCIentinel is a prospective, international, multicenter study aiming to recruit about 118 patients with acute spinal cord injury or control patients with acute vertebral fracture without neurological deficits scheduled for spinal surgery. The assessment points are: i) trauma. Assessment includes infections, concomitant injury, medication and neurological classification using American Spinal Injury Association impairment scale (AIS) and neurological level. Laboratory analyses comprise haematological profiling, immunophenotyping, including HLA-DR expression on monocytes, cytokines and gene expression of immune modulators. We provide an administrative interim analysis of the recruitment schedule of the trial. Discussion The objectives are to characterize the dysfunction of the innate and adaptive immune system after spinal cord injury and to explore its proposed 'neurogenic’ origin

  10. 'Red Ruby': an interactive web-based intervention for lifestyle modification on metabolic syndrome: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jahangiry, Leila; Shojaeizadeh, Davoud; Najafi, Mahdi; Mohammad, Kazem; Abbasalizad Farhangi, Mahdieh; Montazeri, Ali

    2014-07-24

    Although effectiveness of web-based interventions on lifestyle changes are recognized, the potential of such programs on metabolic syndrome has not been explored. We describe the protocol of a randomized controlled trial that aims to determine the feasibility, acceptability, usability, and effectiveness of interactive technology on lifestyle intervention in a population with metabolic syndrome. This is a two-arm randomized controlled trial. The study includes 160 participants (n = 80 per arm) who will be recruited via online registration on the study website. The inclusion criteria are that they should have metabolic syndrome and have access to the Internet. All participants will receive information on dietary intake and physical activity through the study website. The intervention group will receive additional resources via the study website including interactive Healthy Heart Profile and calorie restricted diet tailored to the participants. The primary outcomes are feasibility, acceptability, usability, and the change in metabolic syndrome components. The secondary outcomes are comparing quality of life, physical activity and food intake among the study arms. The participants will be followed up to 6 months with data collection scheduled at baseline, 3 and 6 months. There is a need for developing and evaluating web-based interventions that target people with high risk for cardiovascular diseases. This study will therefore make an important contribution to this novel field of research and practice. IRCT201111198132N1.

  11. The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol.

    Science.gov (United States)

    Back, Hyang-Im; Ha, Ki-Chan; Kim, Hye-Mi; Kim, Min-Gul; Yu, Ok-Kyeong; Byun, Moon-Sun; Jeong, Do-Youn; Jeong, Seong-Yeop; Cha, Youn-Soo; Park, Tae-Sun

    2013-10-31

    Metabolic syndrome is a set of disorders that increases the risk of developing cardiovascular disease. The primary target of treatment of patients with metabolic syndrome is therapeutic lifestyle change. Numerous preclinical study have reported positive effects of chungkookjang in in vivo models of diabetes and obesity, but there is a paucity of controlled clinical trials on variables of metabolic syndrome in obese subjects. Thus, the objective of this trial is to examine the effect of chungkookjang compared to placebo on variables of metabolic syndrome in overweight/obese subjects. This double-blind randomized controlled crossover trial will be conducted on 120 overweight/obese subjects; aged 19-29 years. Subjects will be recruited from the Chonbuk National University, Jeonju, South Korea. Enrolled subjects will be randomly assigned to two groups of equal number; one group received 35 g of chungkookjang (n = 60) and the other group received placebo (n = 60) on a regular daily basis for 12 weeks. After a 12-week washout period, the groups will be crossed over. In addition to anthropometric measures and blood pressure, glucose parameter, lipid profile, adipocytokine, and carnitine assay will be determined at baseline and 12 week. Also, safety will be assessing by measuring total bilirubin, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, total protein, albumin, blood urea nitrogen, creatinine, and creatine kinase at baseline and 12 weeks. 24-hour dietary recalls were collected at the baseline and at the end of the trial. This trial will evaluate the effects of chungkookjang on variables of metabolic syndrome in overweight/obese subjects. The results of this study may contribute to the reduction of risk factor for metabolic syndrome caused by obesity. Clinical trials NCT01811511.

  12. Achieving behaviour change for detection of Lynch syndrome using the Theoretical Domains Framework Implementation (TDFI) approach: a study protocol.

    Science.gov (United States)

    Taylor, Natalie; Long, Janet C; Debono, Deborah; Williams, Rachel; Salisbury, Elizabeth; O'Neill, Sharron; Eykman, Elizabeth; Braithwaite, Jeffrey; Chin, Melvin

    2016-03-12

    Lynch syndrome is an inherited disorder associated with a range of cancers, and found in 2-5 % of colorectal cancers. Lynch syndrome is diagnosed through a combination of significant family and clinical history and pathology. The definitive diagnostic germline test requires formal patient consent after genetic counselling. If diagnosed early, carriers of Lynch syndrome can undergo increased surveillance for cancers, which in turn can prevent late stage cancers, optimise treatment and decrease mortality for themselves and their relatives. However, over the past decade, international studies have reported that only a small proportion of individuals with suspected Lynch syndrome were referred for genetic consultation and possible genetic testing. The aim of this project is to use behaviour change theory and implementation science approaches to increase the number and speed of healthcare professional referrals of colorectal cancer patients with a high-likelihood risk of Lynch syndrome to appropriate genetic counselling services. The six-step Theoretical Domains Framework Implementation (TDFI) approach will be used at two large, metropolitan hospitals treating colorectal cancer patients. Steps are: 1) form local multidisciplinary teams to map current referral processes; 2) identify target behaviours that may lead to increased referrals using discussion supported by a retrospective audit; 3) identify barriers to those behaviours using the validated Influences on Patient Safety Behaviours Questionnaire and TDFI guided focus groups; 4) co-design interventions to address barriers using focus groups; 5) co-implement interventions; and 6) evaluate intervention impact. Chi square analysis will be used to test the difference in the proportion of high-likelihood risk Lynch syndrome patients being referred for genetic testing before and after intervention implementation. A paired t-test will be used to assess the mean time from the pathology test results to referral for high

  13. The AQUA-FONTIS study: protocol of a multidisciplinary, cross-sectional and prospective longitudinal study for developing standardized diagnostics and classification of non-thyroidal illness syndrome

    Directory of Open Access Journals (Sweden)

    Klein Harald H

    2008-10-01

    Full Text Available Abstract Background Non-thyroidal illness syndrome (NTIS is a characteristic functional constellation of thyrotropic feedback control that frequently occurs in critically ill patients. Although this condition is associated with significantly increased morbidity and mortality, there is still controversy on whether NTIS is caused by artefacts, is a form of beneficial adaptation, or is a disorder requiring treatment. Trials investigating substitution therapy of NTIS revealed contradictory results. The comparison of heterogeneous patient cohorts may be the cause for those inconsistencies. Objectives Primary objective of this study is the identification and differentiation of different functional states of thyrotropic feedback control in order to define relevant evaluation criteria for the prognosis of affected patients. Furthermore, we intend to assess the significance of an innovative physiological index approach (SPINA in differential diagnosis between NTIS and latent (so-called "sub-clinical" thyrotoxicosis. Secondary objective is observation of variables that quantify distinct components of NTIS in the context of independent predictors of evolution, survival or pathophysiological condition and influencing or disturbing factors like medication. Design The approach to a quantitative follow-up of non-thyroidal illness syndrome (AQUA FONTIS study is designed as both a cross-sectional and prospective longitudinal observation trial in critically ill patients. Patients are observed in at least two evaluation points with consecutive assessments of thyroid status, physiological and clinical data in additional weekly observations up to discharge. A second part of the study investigates the neuropsychological impact of NTIS and medium-term outcomes. The study design incorporates a two-module structure that covers a reduced protocol in form of an observation trial before patients give informed consent. Additional investigations are performed if and after

  14. How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study

    Science.gov (United States)

    Zheng, Yanhua; Stener-Victorin, Elisabet; Ng, Ernest H Y; Li, Juan; Wu, Xiaoke; Ma, Hongxia

    2015-01-01

    Introduction Hyperinsulinaemia and insulin resistance (IR) are key features of polycystic ovary syndrome (PCOS) and metabolic syndrome. The effect of 5 weeks of acupuncture treatment has been investigated in a completed prospective pilot trial (Clinicaltrials.gov: NCT01457209), and acupuncture with electrical stimulation applied to insulin-resistant rats with dihydrotestosterone-induced PCOS was shown to improve insulin sensitivity. Therefore, we now aim to conduct a prospective pilot study to evaluate whether using the same acupuncture treatment protocol given over a longer period of time (6 months) than in the previous pilot trial will improve insulin sensitivity in women with PCOS and IR. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles will improve insulin sensitivity in women with PCOS and IR. Methods/analysis This is a prospective pilot trial. A total of 112 women with PCOS and IR will be recruited and categorised according to their body mass index (BMI) as normal weight (BMI=18.5−23 kg/m2) or as overweight/obese (BMI>23 kg/m2). Acupuncture will be applied three times per week for 6 months at 30 min per treatment. The primary outcome will be the change in insulin sensitivity before and after 6 months of acupuncture treatment, as measured by an oral glucose tolerance test. Ethics/dissemination Ethical approval of this study has been granted from the ethics committee of the First Affiliated Hospital of Guangzhou Medical University (No. 2013039). Written and informed consent will be obtained from each patient before any study procedure is performed, according to good clinical practice. The results of this trial will be disseminated in a peer-reviewed journal and presented at international congresses. Trial registration numbers NCT02026323 and ChiCTR-OCH-13003921. PMID:25941189

  15. Recommended protocol for failed back surgery syndrome

    Directory of Open Access Journals (Sweden)

    Fakhr Tabatabaei SA

    1996-06-01

    Full Text Available Failed back surgery syndrome (FBSS is many a times an intractable problem confronted in patients with surgical disease of lumbar spine and at the same time is a pressing problem for the physicians as well. This clinical entity is defined as continuation of pain in the lumbar region and lower extremities following surgery of the lumbar spine. Knowledge of the etiological factors and their prevention is the best line of treatment to overcome the evolution of this syndrome. During this study, which was conducted in Imam Khomeini hospital Tehran from the year 1989 till 1990, 43 out of 114 patients developed "FBSS". 23 cases responded to conservative treatment and psychotherapy whereas medical treatment failed to achieve fruitful results in the rest. The latter underwent extensive radiological investigations and repeat surgery. According to this study, we recommend that in the initial management of these patients. The surgeon should observe the dictum of "5-mis" to overcome and minimize the "FBSS" entity

  16. A study protocol of a randomised controlled trial to investigate if a community based strength training programme improves work task performance in young adults with Down syndrome

    Directory of Open Access Journals (Sweden)

    Taylor Nicholas F

    2010-03-01

    Full Text Available Abstract Background Muscle strength is important for young people with Down syndrome as they make the transition to adulthood, because their workplace activities typically emphasise physical rather than cognitive skills. Muscle strength is reduced up to 50% in people with Down syndrome compared to their peers without disability. Progressive resistance training improves muscle strength and endurance in people with Down syndrome. However, there is no evidence on whether it has an effect on work task performance or physical activity levels. The aim of this study is to investigate if a student-led community-based progressive resistance training programme can improve these outcomes in adolescents and young adults with Down syndrome. Methods A randomised controlled trial will compare progressive resistance training with a control group undertaking a social programme. Seventy adolescents and young adults with Down syndrome aged 14-22 years and mild to moderate intellectual disability will be randomly allocated to the intervention or control group using a concealed method. The intervention group will complete a 10-week, twice a week, student-led progressive resistance training programme at a local community gymnasium. The student mentors will be undergraduate physiotherapy students. The control group will complete an arts/social programme with a student mentor once a week for 90 minutes also for 10 weeks to control for the social aspect of the intervention. Work task performance (box stacking, pail carry, muscle strength (1 repetition maximum for chest and leg press and physical activity (frequency, duration, intensity over 7-days will be assessed at baseline (Week 0, following the intervention (Week 11, and at 3 months post intervention (Week 24 by an assessor blind to group allocation. Data will be analysed using ANCOVA with baseline measures as covariates. Discussion This paper outlines the study protocol for a randomised controlled trial on the

  17. Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial

    Science.gov (United States)

    Wildes, T S; Winter, A C; Maybrier, H R; Mickle, A M; Lenze, E J; Stark, S; Lin, N; Inouye, S K; Schmitt, E M; McKinnon, S L; Muench, M R; Murphy, M R; Upadhyayula, R T; Fritz, B A; Escallier, K E; Apakama, G P; Emmert, D A; Graetz, T J; Stevens, T W; Palanca, B J; Hueneke, R L; Melby, S; Torres, B; Leung, J; Jacobsohn, E; Avidan, M S

    2016-01-01

    Introduction Postoperative delirium, arbitrarily defined as occurring within 5 days of surgery, affects up to 50% of patients older than 60 after a major operation. This geriatric syndrome is associated with longer intensive care unit and hospital stay, readmission, persistent cognitive deterioration and mortality. No effective preventive methods have been identified, but preliminary evidence suggests that EEG monitoring during general anaesthesia, by facilitating reduced anaesthetic exposure and EEG suppression, might decrease incident postoperative delirium. This study hypothesises that EEG-guidance of anaesthetic administration prevents postoperative delirium and downstream sequelae, including falls and decreased quality of life. Methods and analysis This is a 1232 patient, block-randomised, double-blinded, comparative effectiveness trial. Patients older than 60, undergoing volatile agent-based general anaesthesia for major surgery, are eligible. Patients are randomised to 1 of 2 anaesthetic approaches. One group receives general anaesthesia with clinicians blinded to EEG monitoring. The other group receives EEG-guidance of anaesthetic agent administration. The outcomes of postoperative delirium (≤5 days), falls at 1 and 12 months and health-related quality of life at 1 and 12 months will be compared between groups. Postoperative delirium is assessed with the confusion assessment method, falls with ProFaNE consensus questions and quality of life with the Veteran's RAND 12-item Health Survey. The intention-to-treat principle will be followed for all analyses. Differences between groups will be presented with 95% CIs and will be considered statistically significant at a two-sided pAnesthesia to Alleviate Geriatric Syndromes (ENGAGES) is approved by the ethics board at Washington University. Recruitment began in January 2015. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and

  18. Network Authentication Protocol Studies

    Science.gov (United States)

    2009-04-01

    This is called the “Decision Diffie-Hellman Problem” ( DDH ) [68]. For the protocols discussed in this paper, the cryptographic strength of the generated...group key is solely dependent upon the strength of the underlying two-party protocols. That said, we will not address the DDH problem further in this

  19. Observational study on efficacy of negative expiratory pressure test proposed as screening for obstructive sleep apnea syndrome among commercial interstate bus drivers - protocol study

    Directory of Open Access Journals (Sweden)

    Hirata Raquel P

    2011-12-01

    enrollment of this study protocol, the expectation is to encounter predictive NEP values for different degrees of OSA in order to contribute toward an early diagnosis of this condition and reduce its impact and complications among commercial interstate bus drivers. Trial registration Registro Brasileiro de Ensaios Clinicos (local acronym RBEC [Internet]: Rio de Janeiro (RJ: Instituto de Informaçao Cientifica e Tecnologica em Saude (Brazil; 2010 - Identifier RBR-7dq5xx. Cross-sectional study on efficacy of negative expiratory pressure test proposed as screening for obstructive sleep apnea syndrome among commercial interstate bus drivers; 2011 May 31 [7 pages]. Available from http://www.ensaiosclinicos.gov.br/rg/RBR-7dq5xx/.

  20. Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Arabi, Yaseen M; Alothman, Adel; Balkhy, Hanan H; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M; Assiri, Abdullah M; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Almekhlafi, Ghaleb A; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Memon, Javed; Taha, Yusri; Almotairi, Abdullah; Maghrabi, Khalid A; Qushmaq, Ismael; Al Bshabshe, Ali; Kharaba, Ayman; Shalhoub, Sarah; Jose, Jesna; Fowler, Robert A; Hayden, Frederick G; Hussein, Mohamed A

    2018-01-30

    It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

  1. A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey.

    Science.gov (United States)

    Kelly, Lauren E; Jansson, Lauren M; Moulsdale, Wendy; Pereira, Jodi; Simpson, Sarah; Guttman, Astrid; Allegaert, Karel; Askie, Lisa; Roukema, Henry; Lacaze, Thierry; Davis, Jonathan M; Finnegan, Loretta; Williamson, Paula; Offringa, Martin

    2016-11-08

    The prevalence of neonatal abstinence syndrome (NAS) is increasing globally resulting in an increased incidence of adverse neonatal outcomes and health system costs. Evidence regarding the effectiveness of NAS prevention and management strategies is very weak and further research initiatives are critically needed to support meta-analysis and clinical practice guidelines. In NAS research, the choice of outcomes and the use of valid, responsive and feasible measurement instruments are crucial. There is currently no consensus and evidence-based core outcome set (COS) for NAS. The development of the NAS-COS will include five stages led by an international Multidisciplinary Steering Committee: (1) qualitative interviews with parents/families and a systematic review (SR) to identify items for inclusion in a COS. The SR will also identify participants for the Delphi survey, (2) a three-round Delphi survey to gain expert opinion on the importance of health outcomes influencing NAS management decisions, (3), a consensus meeting to finalize the items and definitions with experts and COS users, (4) feasibility and pilot testing, development of the COS and explanatory document and (5) implementation planning. Since standardized outcome measurement and reporting will improve NAS clinical research consistency, efficacy and impact, this COS will reflect the minimum set of health outcomes which should be measured in trials evaluating interventions for preventing or treating NAS.

  2. REducing STEroids in Relapsing Nephrotic syndrome: the RESTERN study- protocol of a national, double-blind, randomised, placebo-controlled, non-inferiority intervention study.

    Science.gov (United States)

    Schijvens, A M; Dorresteijn, E M; Roeleveld, N; Ter Heine, R; van Wijk, J A E; Bouts, A H M; Keijzer-Veen, M G; van de Kar, N C A J; van den Heuvel, L P W J; Schreuder, M F

    2017-09-27

    Oral corticosteroids are the first-line treatment for idiopathic childhood nephrotic syndrome. Most children experience several relapses, needing repeated courses of corticosteroid therapy. This exposes them to side effects and long-term complications. For most patients, long-term prognosis is for complete resolution of the disease over time and maintenance of normal kidney function. Therefore, it is vital to focus on minimising adverse events of the disease and its therapy. Unfortunately, no randomised controlled trials are available to determine the optimal corticosteroid treatment of an infrequent relapse of nephrotic syndrome. Recent studies show that treatment schedules for the first episode can safely be shortened to 2 months. The hypothesis of the REducing STEroids in Relapsing Nephrotic syndrome (RESTERN) study is that a 4-week reduction of alternate-day steroids after inducing remission is effective and safe, reduces steroid exposure by 35% on average and is therefore preferable. The RESTERN study is a nationwide, double-blind, randomised, placebo-controlled, non-inferiority intervention study. Children aged 1-18 years with a relapse of steroid-sensitive nephrotic syndrome are eligible for this study. Study subjects (n=144) will be randomly assigned to either current standard therapy in the Netherlands or a reduced prednisolone schedule. The primary outcome of the RESTERN study is the time to first relapse after the final prednisolone dose. The secondary outcomes are the number or relapses, progression to frequent relapsing or steroid dependent nephrotic syndrome and the cumulative dosage of prednisolone during the study period. This non-inferiority trial will be performed in accordance with the Declaration of Helsinki and has been approved by the medical ethical committee of Arnhem-Nijmegen and the Dutch Competent Authority (Central Committee on Research Involving Human Subjects, CCMO). After completion of this study, results will be published in

  3. Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Hong, Shou-Hai; Ding, Sha-Sha; Wu, Fei; Bi, Ying; Xu, Fu; Wan, Yi-Jia; Xuan, Li-Hua

    2017-03-06

    Manual acupuncture (MA) manipulations are one of the key factors influencing acupuncture effects in traditional Chinese medicine theory. Different MA manipulations contain different stimulating parameters, thus generating different acupuncture responses or effects. Evidence has demonstrated that acupuncture is effective for functional dyspepsia (FD). However, the effects of different stimulating parameters of MA manipulations on FD remain unclear. This study is a randomized controlled trial with a four-arm, parallel-group structure. Patients with FD with epigastric pain syndrome (EPS) will be included and randomly allocated into four groups: three MA manipulation groups (separately treated with a frequency of 1 Hz, 2 Hz, or 3 Hz) and a control group. All groups will receive omeprazole as a basic treatment and acupuncture: in the MA manipulation groups, the needles will be manipulated manually with three different frequencies on the basis when de qi is reached, while in the control group, the needles will be inserted without any manipulation. All patients will receive acupuncture treatment of five consecutive sessions per week for 2 weeks and be followed up at 4, 8, and 12 weeks. The primary outcomes of the study include patients' response to the treatment. The secondary outcomes include dyspeptic symptoms, quality of life, mental status, fasting serum gastrin, motilin, and ghrelin concentrations, and adverse events. The protocol was approved by the Ethics committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (2016-K-057-01). The aim of this study is to evaluate the efficacy and safety of MA manipulations with different stimulating parameters (different frequencies) on EPS in patients with FD. Chinese Clinical Trial Registry, ChiCTR-IOR-16008189 . Registered on 30 March 2016.

  4. Randomised controlled trial of online continuing education for health professionals to improve the management of chronic fatigue syndrome: a study protocol.

    Science.gov (United States)

    Li, Sophie H; Sandler, Carolina X; Casson, Sally M; Cassar, Joanne; Bogg, Tina; Lloyd, Andrew R; Barry, Benjamin K

    2017-05-10

    Chronic fatigue syndrome (CFS) is a serious and debilitating illness that affects between 0.2%-2.6% of the world's population. Although there is level 1 evidence of the benefit of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) for some people with CFS, uptake of these interventions is low or at best untimely. This can be partly attributed to poor clinician awareness and knowledge of CFS and related CBT and GET interventions. This trial aims to evaluate the effect of participation in an online education programme, compared with a wait-list control group, on allied health professionals' knowledge about evidence-based CFS interventions and their levels of confidence to engage in the dissemination of these interventions. A randomised controlled trial consisting of 180 consenting allied health professionals will be conducted. Participants will be randomised into an intervention group (n=90) that will receive access to the online education programme, or a wait-list control group (n=90). The primary outcomes will be: 1) knowledge and clinical reasoning skills regarding CFS and its management, measured at baseline, postintervention and follow-up, and 2) self-reported confidence in knowledge and clinical reasoning skills related to CFS. Secondary outcomes include retention of knowledge and satisfaction with the online education programme. The influence of the education programme on clinical practice behaviour, and self-reported success in the management of people with CFS, will also be assessed in a cohort study design with participants from the intervention and control groups combined. The study protocol has been approved by the Human Research Ethics Committee at The University of New South Wales (approval number HC16419). Results will be disseminated via peer-reviewed journal articles and presentations at scientific conferences and meetings. ACTRN12616000296437. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

  5. Community-based physical activity and nutrition programme for adults with metabolic syndrome in Vietnam: study protocol for a cluster-randomised controlled trial.

    Science.gov (United States)

    Tran, Van Dinh; Lee, Andy H; Jancey, Jonine; James, Anthony P; Howat, Peter; Thi Phuong Mai, Le

    2016-06-02

    Metabolic syndrome (MetS) is a cluster of risk factors for cardiovascular diseases and type II diabetes. In Vietnam, more than one-quarter of its population aged 50-65 have MetS. This cluster-randomised controlled trial aims to evaluate the effectiveness of interventions to increase levels of physical activity and improve dietary behaviours among Vietnamese adults aged 50-65 years with MetS. This 6-month community-based intervention includes a range of strategies to improve physical activity and nutrition for adults with MetS in Hanam, a province located in northern Vietnam. 600 participants will be recruited from 6 communes with 100 participants per commune. The 6 selected communes will be randomly allocated to either an intervention group (m=3; n=300) or a control group (m=3; n=300). The intervention comprises booklets, education sessions, resistance bands and attending local walking groups that provide information and encourage participants to improve their physical activity and healthy eating behaviours during the 6-month period. The control group participants will receive standard and 1-time advice. Social cognitive theory is the theoretical concept underpinning this study. Measurements will be taken at baseline and postintervention to evaluate programme effectiveness. The research protocol was approved by the Curtin University Human Research Ethics Committee (approval number: HR139/2014). The results of the study will be disseminated through publications, reports and conference presentations. ACTRN12614000811606. 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/

  6. Validation of a clinical screening instrument for tumour predisposition syndromes in patients with childhood cancer (TuPS) : Protocol for a prospective, observational, multicentre study

    NARCIS (Netherlands)

    Postema, Floor A M; Hopman, Saskia M J; De Borgie, Corianne A J M; Hammond, Peter; Hennekam, Raoul C.; Merks, Johannes H M; Aalfs, Cora M.; Anninga, Jakob K.; Berger, Lieke P V; Bleeker, Fonnet E.; De Bont, Eveline S J M; Dommering, Charlotte J.; Van Eijkelenburg, Natasha K A; Van Den Heuvel-Eibrink, Marry M.; Jongmans, Marjolijn C J; Kors, Wijnanda A.; Letteboer, Tom G W; Loeffen, Jan L C M; Olderode-Berends, Maran J W; Wagner, Anja

    2017-01-01

    Introduction: Recognising a tumour predisposition syndrome (TPS) in patients with childhood cancer is of significant clinical relevance, as it affects treatment, prognosis and facilitates genetic counselling. Previous studies revealed that only half of the known TPSs are recognised during standard

  7. Incorporating thyroid markers in Down syndrome screening protocols.

    Science.gov (United States)

    Dhaifalah, Ishraq; Salek, Tomas; Langova, Dagmar; Cuckle, Howard

    2017-05-01

    The article aimed to assess the benefit of incorporating maternal serum thyroid disease marker levels (thyroid-stimulating hormone and free thyroxine) into first trimester Down syndrome screening protocols. Statistical modelling was used to predict performance with and without the thyroid markers. Two protocols were considered: the combined test and the contingent cell-free DNA (cfDNA) test, where 15-40% women are selected for cfDNA because of increased risk based on combined test results. Published parameters were used for the combined test, cfDNA and the Down syndrome means for thyroid-stimulating hormone and free thyroxine; other parameters were derived from a series of 5230 women screened for both thyroid disease and Down syndrome. Combined test: For a fixed 85% detection rate, the predicted false positive rate was reduced from 5.3% to 3.6% with the addition of the thyroid markers. Contingent cfDNA test: For a fixed 95% detection rate, the proportion of women selected for cfDNA was reduced from 25.6% to 20.2%. When screening simultaneously for maternal thyroid disease and Down syndrome, thyroid marker levels should be used in the calculation of Down syndrome risk. The benefit is modest but can be achieved with no additional cost. © 2017 John Wiley & Sons, Ltd. © 2017 John Wiley & Sons, Ltd.

  8. Antecedent Drug Exposure Aetiology and Management Protocols in Steven-Johnson Syndrome and Toxic Epidermal Necrolysis, A Hospital Based Prospective Study.

    Science.gov (United States)

    Farhat, Samina; Banday, Muddasir; Hassan, Iffat

    2016-01-01

    The study sought to identify the magnitude and characteristic of severe cutaneous adverse reactions (SCAR's) like Steven-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). A prospective study was conducted by the Department of Pharmacology in association with Department of Dermatology in SMHS hospital. The study was carried out from June 2013-June 2015 on hospitalized cases of cutaneous adverse drug reaction reporting in hospital. The SCAR's were reported in a structured questionnaire based on adverse drug reaction (ADR) reporting form provided by the Central Drug Standard Control Organization (CDSCO) Ministry of Health and Family welfare, Government of India. The SCAR's were analysed for their characteristics, causality, severity and prognosis. Causality assessment was done by using a validated ADR probability scale of Naranjo as well as WHO Uppsala Monitoring Center (WHO-UMC) system for standardized case causality assessment. The management protocol were analysed for their clinical outcome through a proper follow up period. A total of 52 hospitalized cases of cutaneous adverse drug reactions were reported during the study period. We identified a total of 15 cases (28%) of SCAR's involving 9(17%) of SJS and 6 (12%) of TEN. SJS was seen in 2(22%) males and 7(78%) females. TEN was seen in all females (100%) and in no male. Drugs implicated in causing these life threatening reactions were identified as anticonvulsant agents like carbamazepine (CBZ), phenytoin (PHT) and Lamotrigine (LTG), oxicam NSAID, Sulfasalazine and levofloxacin. Despite higher reported mortality rates in SJS and TEN all patients survived with 2 patients surviving TEN suffered from long term opthalmological sequelae of the disease. Present study suggest that drug induced cutaneous eruptions are common ranging from common nuisance rashes to rare life threatening diseases like SJS and TEN, SJS/TEN typically occur 1-3 weeks after initiation of therapy. Aromatic AED's, LTG, oxicam NSAID

  9. The DOMUS study protocol

    DEFF Research Database (Denmark)

    Nordly, Mie; Benthien, Kirstine Skov; Von Der Maase, Hans

    2014-01-01

    BACKGROUND: The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate...... is a controlled randomized clinical trial with a balanced parallel-group randomization (1:1). The planned sample size is 340 in- and outpatients treated at the Department of Oncology at Copenhagen University Hospital. Patients are randomly assigned either to: a) standard care plus SPC enriched with a standardized...... be a powerful tool to improve patients' quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient's preferred place of care and attempt to clarify challenges. TRIAL REGISTRATION: Clinicaltrials...

  10. REducing STEroids in Relapsing Nephrotic syndrome: the RESTERN study- protocol of a national, double-blind, randomised, placebo-controlled, non-inferiority intervention study

    NARCIS (Netherlands)

    Schijvens, A. M.; Dorresteijn, E. M.; Roeleveld, N.; ter Heine, R.; van Wijk, J. A. E.; Bouts, A. H. M.; Keijzer-Veen, M. G.; van de Kar, N. C. A. J.; van den Heuvel, L. P. W. J.; Schreuder, M. F.

    2017-01-01

    Introduction Oral corticosteroids are the first-line treatment for idiopathic childhood nephrotic syndrome. Most children experience several relapses, needing repeated courses of corticosteroid therapy. This exposes them to side effects and long-term complications. For most patients, long-term

  11. REducing STEroids in Relapsing Nephrotic syndrome : the RESTERN study- protocol of a national, double-blind, randomised, placebo-controlled, non-inferiority intervention study

    NARCIS (Netherlands)

    Schijvens, A M; Dorresteijn, Eiske M.; Roeleveld, N.; ter Heine, R.; van Wijk, Joanna A E; Bouts, Antonia H M; Keijzer-Veen, M G; van de Kar, Nicole C A J; van den Heuvel, L P W J; Schreuder, M F

    2017-01-01

    INTRODUCTION: Oral corticosteroids are the first-line treatment for idiopathic childhood nephrotic syndrome. Most children experience several relapses, needing repeated courses of corticosteroid therapy. This exposes them to side effects and long-term complications. For most patients, long-term

  12. REducing STEroids in Relapsing Nephrotic syndrome: the RESTERN study- protocol of a national, double-blind, randomised, placebo-controlled, non-inferiority intervention study

    NARCIS (Netherlands)

    Schijvens, A.M.; Dorresteijn, E.M.; Roeleveld, N.; Heine, R. ter; Wijk, J.A. van; Bouts, A.H.M.; Keijzer-Veen, M.G.; Kar, N.C.A.J. van de; Heuvel, L.P.W.J. van den; Schreuder, M.F.

    2017-01-01

    INTRODUCTION: Oral corticosteroids are the first-line treatment for idiopathic childhood nephrotic syndrome. Most children experience several relapses, needing repeated courses of corticosteroid therapy. This exposes them to side effects and long-term complications. For most patients, long-term

  13. REducing STEroids in Relapsing Nephrotic syndrome: the RESTERN study— protocol of a national, double-blind, randomised, placebo-controlled, non-inferiority intervention study

    Science.gov (United States)

    Schijvens, A M; Dorresteijn, E M; Roeleveld, N; ter Heine, R; van Wijk, J A E; Bouts, A H M; Keijzer-Veen, M G; van de Kar, N C A J; van den Heuvel, L P W J; Schreuder, M F

    2017-01-01

    Introduction Oral corticosteroids are the first-line treatment for idiopathic childhood nephrotic syndrome. Most children experience several relapses, needing repeated courses of corticosteroid therapy. This exposes them to side effects and long-term complications. For most patients, long-term prognosis is for complete resolution of the disease over time and maintenance of normal kidney function. Therefore, it is vital to focus on minimising adverse events of the disease and its therapy. Unfortunately, no randomised controlled trials are available to determine the optimal corticosteroid treatment of an infrequent relapse of nephrotic syndrome. Recent studies show that treatment schedules for the first episode can safely be shortened to 2 months. The hypothesis of the REducing STEroids in Relapsing Nephrotic syndrome (RESTERN) study is that a 4-week reduction of alternate-day steroids after inducing remission is effective and safe, reduces steroid exposure by 35% on average and is therefore preferable. Methods and analysis The RESTERN study is a nationwide, double-blind, randomised, placebo-controlled, non-inferiority intervention study. Children aged 1–18 years with a relapse of steroid-sensitive nephrotic syndrome are eligible for this study. Study subjects (n=144) will be randomly assigned to either current standard therapy in the Netherlands or a reduced prednisolone schedule. The primary outcome of the RESTERN study is the time to first relapse after the final prednisolone dose. The secondary outcomes are the number or relapses, progression to frequent relapsing or steroid dependent nephrotic syndrome and the cumulative dosage of prednisolone during the study period. Ethics and dissemination This non-inferiority trial will be performed in accordance with the Declaration of Helsinki and has been approved by the medical ethical committee of Arnhem-Nijmegen and the Dutch Competent Authority (Central Committee on Research Involving Human Subjects, CCMO

  14. A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare': Study protocol

    Directory of Open Access Journals (Sweden)

    Hare David L

    2011-02-01

    Full Text Available Abstract Background Coronary heart disease (CHD and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL, decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare for depression and CHD secondary prevention, with Usual Care (UC. Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group. The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake, medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1, 6 months (post-intervention (Time 2, 12 months (Time 3 and 24 months follow-up for longer term effects (Time 4. We are comparing depression (Cardiac Depression Scale [CDS] and HRQOL (Short Form-12 [SF-12] scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of

  15. EFFICACY AND SAFETY OF ACCELERATED DIAGNOSTIC PROTOCOL USE IN PATIENTS WITH SUSPECTED ACUTE CORONARY SYNDROME

    Directory of Open Access Journals (Sweden)

    O. V. Baturina

    2014-01-01

    Full Text Available The use of modern accelerated diagnostic protocols in patients with suspected acute coronary syndrome is discussed. Evidence base that can give occasion to selection of acceptable accelerated diagnostic protocol for safe exclusion of acute myocardial infarction early after seeking medical attention is presented. Advantages and disadvantages of certain protocols are discussed.

  16. Protocol for physical assessment in patients with fibromyalgia syndrome.

    Science.gov (United States)

    dos Santos, Michele R; Moro, Claudia M C; Vosgerau, Dilmeire S R

    2014-01-01

    Fibromyalgia syndrome (FMS) is a chronic disease that causes pain and fatigue, presenting a negative impact on quality of life. Exercise helps maintaining physical fitness and influences directly on the improvement of quality of life. Develop a protocol for health-related physical fitness assessment of patients with FMS with tests that are feasible and appropriate for this population. An exploratory and analytical literature review was performed, seeking to determine the tests used by the scientific community. With this in mind, we performed a literature revision through the use of virtual libraries databases: PubMed, Bireme, Banco de Teses e Dissertações da Capes and Biblioteca Digital Brasileira de Teses e Dissertações, published in between 1992-2012. A variety of tests was found; the following, by number of citations, stood out: Body Mass Index (BMI) and bioimpedance; 6-minute walk; handgrip strength (dynamometer, 1RM [Repetition Maximum]); Sit and reach and Shoulder flexibility; Foot Up and Go, and Flamingo balance. These are the tests that should make up the protocol for the physical evaluation of FMS patients, emphasizing their ease of use.

  17. Publication trends of study protocols in rehabilitation.

    Science.gov (United States)

    Jesus, Tiago S; Colquhoun, Heather L

    2017-09-04

    Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved

  18. Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

    Science.gov (United States)

    Pastora-Bernal, Jose-Manuel; Martín-Valero, Rocío; Barón-López, Francisco Javier; García-Gómez, Oscar

    2017-02-23

    Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery. We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design. Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing. ClinicalTrials.gov, NCT02909920 . 14 September 2016.

  19. Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo)

    NARCIS (Netherlands)

    Vos-Vromans, D.C.; Smeets, R.J.P.; Rijnders, L.J.; Gorrissen, R.R.; Pont, M.; Koke, A.J.; Hitters, M.W.; Evers, S.M.; Knottnerus, A.J.

    2012-01-01

    ABSTRACT: BACKGROUND: Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to

  20. Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture-controlled trial.

    Science.gov (United States)

    Qin, Zongshi; Zang, Zhiwei; Wu, Jiani; Zhou, Jing; Liu, Zhishun

    2016-11-07

    Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. The currently available therapies offer little or no proven benefit for CP/CPPS. We designed this study to assess the efficacy of acupuncture therapy for the treatment of CP/CPPS. This study is designed as a randomized, sham acupuncture-controlled trial. We will compare patients with CP/CPPS in an acupuncture group and a sham acupuncture group. Sixty-eight patients will be randomly allocated to receive acupuncture or sham acupuncture. The treatments will consist of 30-min sessions, three times weekly, for 8 weeks. The primary outcome measure is change in the weekly mean National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline through the 8-week treatment period. Secondary measures include the NIH-CPSI subscale scores, the total International Prostate Symptom Score (IPSS), patients' response rate, and patient satisfaction after treatment. We will also assess changes in the NIH-CPSI total score from baseline at the 20 th and 32 nd week of follow-up. This is a randomized, sham-controlled trial of acupuncture treatment for CP/CPPS. The results of this trial will provide more evidence on whether acupuncture is efficacious for treating CP/CPPS. Clinical Trials.gov NCT02588274.

  1. The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial

    Directory of Open Access Journals (Sweden)

    Xuemei Liu

    2017-01-01

    Full Text Available Background. Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS is an important but less addressed traditional Chinese medicine (TCM pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG for treating CCQDS. Methods/Design. This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 eligible patients will be recruited from five centers. Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson’s scale, and TCM symptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson’s scale and TCM symptom scale. Ethics and Trial Registration. This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12 and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349.

  2. Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lee Beom-Joon

    2011-10-01

    Full Text Available Abstract Background Irritable bowel syndrome (IBS is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habits without organic disease. Many patients seek alternative IBS treatments because of the limitations of conventional treatments. Gwakhyangjeonggisan (GJS, a herbal formula, has long been used for alleviating diarrhea-predominant IBS (D-IBS in traditional medicine. Duolac7S, which comprises 7 bacterial species as probiotics, has been frequently used for D-IBS. Although GJS and Duolac7S have been administered simultaneously in many D-IBS patients, no study has investigated the effects of GJS and Duolac7S combination therapy on D-IBS. Methods/Design The current trial is a randomized, double-blinded, placebo-controlled, 4-arm study. After a 2-week run-in period, 60 patients with D-IBS will be randomly assigned to one of the 4 combination groups consisting of GJS (water extract granules, 3 g/pack, 3 times a day with Duolac7S (powder form, 1 capsule, 2 times a day or their placebos and followed up for 2 weeks. The assigned treatments will last for 8 weeks. The primary outcomes are adequate relief of IBS pain and discomfort and the proportion of responders (on a weekly basis. The secondary outcomes are visual analog scale for IBS symptoms (on a daily basis, quality of life (at 0, 8, and 10 weeks, intestinal permeability, and composition of intestinal microbiota (at 0 and 8 weeks. Discussion The present study is designed to examine the safety and efficacy of GJS and Duolac7S combination therapy on D-IBS. Our study provides the clinical evidence of a new therapeutic strategy for D-IBS. Trial registration ClinicalTrials.gov NCT01342718.

  3. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy

    Science.gov (United States)

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-01-01

    Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN

  4. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy.

    Science.gov (United States)

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-07-30

    A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370.

  5. Clinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Collings, Sunny; Mathieson, Fiona; Dowell, Anthony; Stanley, James; Hatcher, Simon; Goodyear-Smith, Felicity; Lane, Brigitte; Munsterman, Amy

    2015-06-05

    Although mild to moderate mental health problems are common and often debilitating, treatment options in primary care settings in New Zealand are often severely limited for patients with these conditions. Previously, we developed an ultra-brief intervention (UBI) to address mild to moderate psychological concerns, designed to be delivered by primary care clinicians. Recent feasibility testing, including an adaptation for Māori individuals (the indigenous people of New Zealand), showed that the brief intervention was feasible and acceptable to both clinicians and their patients. This protocol describes a large pragmatic randomized controlled trial of our UBI in primary care settings across the greater Wellington region, compared with practice as usual. We are using a two-arm cluster randomized controlled trial, with primary care practices randomized to exclusively deliver either the UBI or practice as usual to all their recruited participants. The structured, guided self-help UBI is delivered in three brief general practitioner (GP) appointments over a five week period. Participants are invited into the study based on partner primary health organization access criteria (youth, people with low income, or people with Māori or Pacific Island heritage). Improvements in mental health from baseline to post-treatment will be compared between the intervention and control groups using a mixed-models application of analysis of covariance. Data analysis will be on an intention-to-treat basis, to increase the real-world relevance of UBI and to meet the study's objective of releasing UBI to primary care clinicians nationwide. The UBI is a first-line intervention tool for GPs that models the stepped care approach advocated in New Zealand, against a background of limited access to treatments for often-overlooked patient groups. It is proposed to be accessible to clinicians and patients alike, with the potential to be relevant to primary care clinicians across New Zealand

  6. The effects of probiotic and synbiotic supplementation on metabolic syndrome indices in adults at risk of type 2 diabetes: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kassaian, Nazila; Aminorroaya, Ashraf; Feizi, Awat; Jafari, Parvaneh; Amini, Masoud

    2017-03-29

    The incidence of type 2 diabetes, cardiovascular diseases, and obesity has been rising dramatically; however, their pathogenesis is particularly intriguing. Recently, dysbiosis of the intestinal microbiota has emerged as a new candidate that may be linked to metabolic diseases. We hypothesize that selective modulation of the intestinal microbiota by probiotic or synbiotic supplementation may improve metabolic dysfunction and prevent diabetes in prediabetics. In this study, a synthesis and study of synbiotics will be carried out for the first time in Iran. In a randomized triple-blind controlled clinical trial, 120 adults with impaired glucose tolerance based on the inclusion criteria will be selected by a simple random sampling method and will be randomly allocated to 6 months of 6 g/d probiotic, synbiotic or placebo. The fecal abundance of bacteria, blood pressure, height, weight, and waist and hip circumferences will be measured at baseline and following treatment. Also, plasma lipid profiles, HbA1C, fasting plasma glucose, and insulin levels, will be measured and insulin resistance (HOMA-IR) and beta-cell function (HOMA-B) will be calculated at baseline and will be repeated at months 3, 6, 12, and 18. The data will be compared within and between groups using statistical methods. The results of this trial could contribute to the evidence-based clinical guidelines that address gut microbiota manipulation to maximize health benefits in prevention and management of metabolic syndrome in prediabetes. Iranian Registry of Clinical Trials: IRCT201511032321N2 . Registered on 27 February 2016.

  7. Treatment with L-citrulline in patients with post-polio syndrome: study protocol for a single-center, randomised, placebo-controlled, double-blind trial.

    Science.gov (United States)

    Schmidt, Simone; Gocheva, Vanya; Zumbrunn, Thomas; Rubino-Nacht, Daniela; Bonati, Ulrike; Fischer, Dirk; Hafner, Patricia

    2017-03-09

    Post-polio syndrome (PPS) is a condition that affects polio survivors years after recovery from an initial acute infection by the Poliomyelitis virus. Most often, patients who suffered from polio start to experience gradual new weakening in muscles, a gradual decrease in the size of muscles (muscle atrophy) and fatigue years after the acute illness. L-citrulline is known to change muscular metabolism synthesis by raising nitric oxide (NO) levels and increasing protein synthesis. This investigator-initiated, randomised, placebo-controlled, double-blind, trial aims to demonstrate that L-citrulline positively influences muscle function and increases muscular energy production in patients with PPS. Thirty ambulant PPS patients will be recruited in Switzerland. Patients will be randomly allocated to one of the two arms of the study (placebo:verum 1:1). After a 24-week run-in phase to observe natural disease history and progression, participants will be treated either with L-citrulline or placebo for 24 weeks. The primary endpoint is change in the 6-min Walking Distance Test. Secondary endpoints will include motor function measure, quantitative muscle force, quantitative muscle magnetic resonance imaging and magnetic resonance spectroscopy and serum biomarker laboratory analysis DISCUSSION: The aim of this phase IIa trial is to determine if treatment with L-citrulline shows a positive effect on clinical function and paraclinical biomarkers in PPS. If treatment with L-citrulline shows positive effects, this might represent a cost-efficient symptomatic therapy for PPS patients. ClinicalTrial.gov, ID: NCT02801071 . Registered on 6 June 2016.

  8. Different exercise protocols improve metabolic syndrome markers, tissue triglycerides content and antioxidant status in rats

    Directory of Open Access Journals (Sweden)

    Botezelli José D

    2011-12-01

    Full Text Available Abstract Background An increase in the prevalence of obesity entails great expenditure for governments. Physical exercise is a powerful tool in the combat against obesity and obesity-associated diseases. This study sought to determine the effect of three different exercise protocols on metabolic syndrome and lipid peroxidation markers and the activity of antioxidant enzymes in adult Wistar rats (120 days old. Methods Animals were randomly divided into four groups: the control (C group was kept sedentary throughout the study; the aerobic group (A swam1 h per day, 5 days per week, at 80% lactate threshold intensity; the strength group (S performed strength training with four series of 10 jumps, 5 days per week; and the Concurrent group (AS was trained using the aerobic protocol three days per week and the strength protocol two days per week. Results Groups A and S exhibited a reduction in body weight compared to group C. All exercised animals showed a reduction in triglyceride concentrations in fatty tissues and the liver. Exercised animals also exhibited a reduction in lipid peroxidation markers (TBARS and an increase in serum superoxide dismutase activity. Animals in group A had increased levels of liver catalase and superoxide dismutase activities. Conclusions We concluded that all physical activity protocols improved the antioxidant systems of the animals and decreased the storage of triglycerides in the investigated tissues.

  9. Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo

    Directory of Open Access Journals (Sweden)

    Vos-Vromans Desirée CWM

    2012-05-01

    Full Text Available Abstract Background Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome. Methods One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators—self-efficacy, causal attributions and present-centred attention-awareness—will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life

  10. The effect of MElatonin on Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome (MEDACIS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Madsen, Michael Tvilling; Isbrand, Anders; Andersen, Ulla Overgaard; Andersen, Lars Juel; Taskiran, Mustafa; Simonsen, Erik; Gögenur, Ismail

    2017-02-23

    Depression following acute coronary syndrome (ACS) constitutes a serious and debilitating problem. Approximately one in five patients will develop significant depression following ACS and less severe depressive symptoms are even more frequent. Furthermore, anxiety symptoms and sleep-wake disturbances are frequent. The objective of the MEDACIS trial is to investigate whether prophylactic treatment with melatonin has a preventive effect on depression, depressive and anxiety symptoms, sleep, and circadian disturbances following ACS. "The effect of MElatonin and Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome" trial (MEDACIS) is a multicenter, double-blinded, placebo-controlled, randomized clinical trial. A total of 240 patients with ACS and no depressive symptoms will be included in the trial for treatment with either 25 mg melatonin or placebo for a 12-week period. Development and severity of depressive symptoms will be evaluated using Major Depression Inventory every 2 weeks with the purpose of investigating the potential preventive effect of melatonin on depressive symptoms. Previously, only selective serotonin reuptake inhibitors (SSRIs) have been investigated in a primary preventive setup in patients following ACS. However, SSRIs are associated with several side effects. An ideal intervention would constitute the highest degree of prevention of depressive symptoms with the lowest risk of side effects. In this regard, melatonin may have advantages due to its low toxicity as well as its proven anxiolytic and hypnotic effects. ClinicalTrials.gov, Identifier: NCT02451293 . Registered on 12 May 2015. EudraCT nr. 2015-002116-32.

  11. Compassionate Use Protocol for the Treatment of Autoinflammatory Syndromes

    Science.gov (United States)

    2018-03-16

    Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature (CANDLE); Juvenile Dermatomyositis (JDM); Stimulator of Interferon Genes (STING)-Associated Vasculopathy With Onset During Infancy (SAVI); Aicardi-Goutières Syndrome (AGS)

  12. Evaluation of homoeopathic medicines as add-on to institutional management protocol in Acute Encephalitis Syndrome: An exploratory observational comparative study

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2015-01-01

    Conclusion: This exploratory observational study suggests reduction of mortality and morbidity with add-on homoeopathic medicine. Further randomized controlled trial study with comparable groups is desirable. If findings are confirmed by subsequent research, add-on Homoeopathy might have relevant implication for its management.

  13. NEURAPRO-E study protocol

    DEFF Research Database (Denmark)

    Markulev, Connie; McGorry, Patrick D; Nelson, Barnaby

    2017-01-01

    polyunsaturated fatty acids (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study......AIM: Recent research has indicated that preventative intervention is likely to benefit patients 'at-risk' for psychosis, both in terms of symptom reduction and delay or prevention of onset of threshold psychotic disorder. The strong preliminary results for the effectiveness of omega-3...... omega-3 PUFAs plus cognitive-behavioural case management (CBCM) will be less likely to transition to psychosis over a 6-month period compared to treatment with placebo plus CBCM. Secondary outcomes will examine symptomatic and functional changes, as well as examine if candidate risk factors predict...

  14. ART Outcomes in GnRH Antagonist Protocol (Flexible) and Long GnRH Agonist Protocol during Early Follicular Phase in Patients with Polycystic Ovary Syndrome: A Randomized Clinical Trial

    Science.gov (United States)

    Mokhtar, Sara; Sadeghi, Mohammad Reza; Akhondi, Mohammad Mehdi; Zafardoust, Simin; Badenush, Bita; Fatemi, Farnaz; Nazari, Fattane; Kamali, Koorosh; Mohammadzade, Afsaneh

    2015-01-01

    Background: Since increased LH in the early follicular phase in PCOS patients especially in GnRH antagonist protocol could be associated with reduced oocyte quality and pregnancy and impared implantation. The current study was conducted to determine ART outcomes in GnRH antagonist protocol (flexible) and long GnRH agonist protocol and compare them with adding GnRH antagonist in GnRH antagonist (flexible) protocol during early follicular phase in patients with polycystic ovary syndrome undergoing ICSI. Methods: In this randomized clinical trial, 150 patients with polycystic ovary syndrome undergoing ICSI were enrolled from 2012 to 2014 and randomly assigned to receive either GnRH antagonist protocol during early and late follicular phase or GnRH antagonist protocol (flexible) or long GnRH agonist protocol. The clinical and laboratory pregnancy in three groups was determined and compared. In this context, the chi-square and Fisher's exact test and ANOVA were used for data analysis. Statistical significance was defined as p<0.05. Results: There was no statistically significant difference with respect to chemical pregnancy and clinical pregnancy between the three groups. Also, other indices such as number and quality of oocytes and embryos were alike. Conclusion: Totally, according to our results, GnRH antagonist protocol during early and late follicular phase and GnRH antagonist protocol (flexible) and long GnRH agonist protocol in patients with polycystic ovary syndrome undergoing ICSI are similarly effective and use of each one based on patients' condition and physicians' opinion could be considered. PMID:26913233

  15. Three year outcome of childhood idiopathic nephrotic syndrome under a unified immunosuppressive protocol.

    Science.gov (United States)

    Hibino, Satoshi; Uemura, Osamu; Nagai, Takuhito; Yamakawa, Satoshi; Iwata, Naoyuki; Ito, Hidekazu; Nakano, Masaru; Tanaka, Kazuki

    2015-01-01

    This retrospective study was performed to assess the 3 year outcome of a unified protocol for childhood idiopathic nephrotic syndrome. Cyclosporine A (CsA) or CsA plus mycophenolate mofetil (MMF) were used in patients without remission on high-dose steroid therapy. CsA was maintained at an area under the whole blood concentration-time curve up to 4 h after dose (AUC0-4 ) of 1500 and 2000 ng·h/mL in steroid-dependent nephrotic syndrome (SDNS) and steroid-resistant nephrotic syndrome (SRNS), respectively. Ninety-one children were enrolled in the study (SDNS, n = 64; SRNS, n = 18). Patients were divided into minimal change (MC) and focal segmental glomerulosclerosis (FSGS) groups. Three year outcome was evaluated using clinical severity defined as degree of dependence on immunosuppressive therapy for maintenance of remission. In the SDNS group, the numbers of MC and no biopsy were 51 and 13, respectively. No patient had FSGS. Twelve SRNS patients had FSGS and six had MC. In SDNS, 15/64 patients (23%) received no medication. CsA was effective as steroid-sparing agent in 31/38 patients (82%). MMF was effective in all eight patients for whom CsA was unsuccessful. Remission rate in the SRNS group was 14/18 (78%; eight with CsA, and six with a combination of CsA + MMF). Five of the 14 SRNS remission patients received methylprednisolone pulse therapy. Four were resistant to therapy, and had impaired renal function. The clinical severity of MC and FSGS overlapped. Treatment with CsA and combination of CsA plus MMF was useful for SDNS and for remission induction in SRNS. © 2014 Japan Pediatric Society.

  16. A combination of ascorbic acid and α-tocopherol to test the effectiveness and safety in the fragile X syndrome: study protocol for a phase II, randomized, placebo-controlled trial.

    Science.gov (United States)

    de Diego-Otero, Yolanda; Calvo-Medina, Rocio; Quintero-Navarro, Carolina; Sánchez-Salido, Lourdes; García-Guirado, Francisco; del Arco-Herrera, Ignacio; Fernández-Carvajal, Isabel; Ferrando-Lucas, Teresa; Caballero-Andaluz, Rafaela; Pérez-Costillas, Lucia

    2014-09-03

    Fragile X syndrome (FXS) is an inherited neurodevelopmental condition characterised by behavioural, learning disabilities, physical and neurological symptoms. In addition, an important degree of comorbidity with autism is also present. Considered a rare disorder affecting both genders, it first becomes apparent during childhood with displays of language delay and behavioural symptoms.Main aim: To show whether the combination of 10 mg/kg/day of ascorbic acid (vitamin C) and 10 mg/kg/day of α-tocopherol (vitamin E) reduces FXS symptoms among male patients ages 6 to 18 years compared to placebo treatment, as measured on the standardized rating scales at baseline, and after 12 and 24 weeks of treatment.Secondary aims: To assess the safety of the treatment. To describe behavioural and cognitive changes revealed by the Developmental Behaviour Checklist Short Form (DBC-P24) and the Wechsler Intelligence Scale for Children-Revised. To describe metabolic changes revealed by blood analysis. To measure treatment impact at home and in an academic environment. A phase II randomized, double-blind pilot clinical trial. male children and adolescents diagnosed with FXS, in accordance with a standardized molecular biology test, who met all the inclusion criteria and none of the exclusion criteria. clinical data, blood analysis, Wechsler Intelligence Scale for Children-Revised, Conners parent and teacher rating scale scores and the DBC-P24 results will be obtained at the baseline (t0). Follow up examinations will take place at 12 weeks (t1) and 24 weeks (t2) of treatment. A limited number of clinical trials have been carried out on children with FXS, but more are necessary as current treatment possibilities are insufficient and often provoke side effects. In the present study, we sought to overcome possible methodological problems by conducting a phase II pilot study in order to calculate the relevant statistical parameters and determine the safety of the proposed treatment. The

  17. The efficacy and safety of Jian-Wei-Qu-Tong Pills for the treatment of chronic non-atrophic gastritis (spleen and stomach qi deficiency with damp-heat stasis syndrome): study protocol for a phase II, randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Chronic gastritis (CG), a poorly understood entity, is a very common disease of the digestive tract and is difficult to cure. Chronic non-atrophic gastritis (CNG) is the most common type of CG. Even if treated with current standard chemotherapy, some patients will not be freed from this confusing disease. Many studies have shown traditional Chinese medicine (TCM) is more effective compared to chemotherapy in the treatment of chronic gastritis and no serious side effects have been identified. However, the studies that have been carried out were not scientifically rigorous trials. Our aim is to design a high-quality trial for a new TCM drug, the Jian-Wei-Qu-Tong Pills (JWQTP), to investigate the efficacy and safety of this new drug in treating chronic non-atrophic gastritis patients with spleen and stomach qi deficiency with damp-heat stasis syndrome (SSQDDSS). Methods/Design This is a phase II, multicenter, parallel-group, double-blind, randomized and placebo-controlled trial. A total of 240 participants will be assigned to a high-dose group, a low-dose group or a placebo control group with a 1:1:1 ratio at five sites. Then, one dose (six 1-g pills), with a variable ratio between real drug and dummy drug according to the intervention protocol, will be taken three times a day before each meal for 8 weeks. The primary outcome is the eradication rate of epigastric pain. The secondary outcome includes the changes of endoscopic examination, histopathological examination, traditional Chinese medicine symptom scores and patient-reported outcome instrument scores for chronic gastrointestinal diseases and the eradication rate of Helicobacter pylori (HP). Discussion Many CNG patients suffer from frequent, recurrent bouts of dyspeptic symptoms. This is the first clinical trial to evaluate the safety and efficacy of JWQTP in treating CNG with SSQDDSS in a multicenter, parallel-group, double-blind, randomized and placebo-controlled manner. This trial may not only

  18. Fatigue Intervention by Nurses Evaluation – The FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610

    Directory of Open Access Journals (Sweden)

    Dunn G

    2006-04-01

    Full Text Available Abstract Background Chronic fatigue syndrome, also known as ME (CFS/ME, is a condition characterised primarily by severe, disabling fatigue, of unknown origin, which has a poor prognosis and serious personal and economic consequences. Evidence for the effectiveness of any treatment for CFS/ME in primary care, where most patients are seen, is sparse. Recently, a brief, pragmatic treatment for CFS/ME, based on a physiological dysregulation model of the condition, was shown to be successful in improving fatigue and physical functioning in patients in secondary care. The treatment involves providing patients with a readily understandable explanation of their symptoms, from which flows the rationale for a graded rehabilitative plan, developed collaboratively with the therapist. The present trial will test the effectiveness and cost-effectiveness of pragmatic rehabilitation when delivered by specially trained general nurses in primary care. We selected a client-centred counselling intervention, called supportive listening, as a comparison treatment. Counselling has been shown to be as effective as cognitive behaviour therapy for treating fatigue in primary care, is more readily available, and controls for supportive therapist contact time. Our control condition is treatment as usual by the general practitioner (GP. Methods and design This study protocol describes the design of an ongoing, single-blind, pragmatic randomized controlled trial of a brief (18 week self-help treatment, pragmatic rehabilitation, delivered by specially trained nurse-therapists in patients' homes, compared with nurse-therapist delivered supportive listening and treatment as usual by the GP. An economic evaluation, taking a societal viewpoint, is being carried out alongside the clinical trial. Three adult general nurses were trained over a six month period to deliver the two interventions. Patients aged over 18 and fulfilling the Oxford criteria for CFS are assessed at baseline

  19. Fatigue Intervention by Nurses Evaluation--the FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610].

    Science.gov (United States)

    Wearden, A J; Riste, L; Dowrick, C; Chew-Graham, C; Bentall, R P; Morriss, R K; Peters, S; Dunn, G; Richardson, G; Lovell, K; Powell, P

    2006-04-07

    Chronic fatigue syndrome, also known as ME (CFS/ME), is a condition characterised primarily by severe, disabling fatigue, of unknown origin, which has a poor prognosis and serious personal and economic consequences. Evidence for the effectiveness of any treatment for CFS/ME in primary care, where most patients are seen, is sparse. Recently, a brief, pragmatic treatment for CFS/ME, based on a physiological dysregulation model of the condition, was shown to be successful in improving fatigue and physical functioning in patients in secondary care. The treatment involves providing patients with a readily understandable explanation of their symptoms, from which flows the rationale for a graded rehabilitative plan, developed collaboratively with the therapist. The present trial will test the effectiveness and cost-effectiveness of pragmatic rehabilitation when delivered by specially trained general nurses in primary care. We selected a client-centred counselling intervention, called supportive listening, as a comparison treatment. Counselling has been shown to be as effective as cognitive behaviour therapy for treating fatigue in primary care, is more readily available, and controls for supportive therapist contact time. Our control condition is treatment as usual by the general practitioner (GP). This study protocol describes the design of an ongoing, single-blind, pragmatic randomized controlled trial of a brief (18 week) self-help treatment, pragmatic rehabilitation, delivered by specially trained nurse-therapists in patients' homes, compared with nurse-therapist delivered supportive listening and treatment as usual by the GP. An economic evaluation, taking a societal viewpoint, is being carried out alongside the clinical trial. Three adult general nurses were trained over a six month period to deliver the two interventions. Patients aged over 18 and fulfilling the Oxford criteria for CFS are assessed at baseline, after the intervention, and again one year later

  20. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research to qu...... the statistical principles for trial protocols in terms of design, analysis, and reporting of findings....

  1. Protocol for assessing alcohol withdrawal syndrome by nursing professionals in emergency services: a pilot test

    OpenAIRE

    Luis,Margarita Antonia Villar; Lunetta,Ana Carolina Fuza; Ferreira,Paulo Sérgio

    2008-01-01

    OBJECTIVES: This work speaks of a pilot test administered in four public services with emergency care (one at a hospital and three at community clinics) in the city of Ribeirão Preto, São Paulo, to test an assessment protocol for Alcohol Withdrawal Syndrome. Involved were auxiliaries, technicians and soon-to-be-nurses. The object was to evaluate the protocol´s potential as a guide to nursing care, and to test whether it was adequate in terms of comprehension and applicability. METHODS: A prot...

  2. Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome and healthy control participants: study protocol for an exploratory randomized double- blind placebo-controlled trial.

    LENUS (Irish Health Repository)

    O'Connell, Karen

    2013-08-01

    There is increasing evidence linking vitamin D deficiency to both susceptibility to, and severity of, multiple sclerosis (MS). Patients with the clinically isolated syndrome represent the initial presentation of a demyelinating disorder, and those with asymptomatic lesions on magnetic resonance imaging (MRI) are at risk of progression to clinically definite MS. The aims of this study are to examine the immunologic effects of vitamin D in both healthy individuals and in patients with clinically isolated syndrome, and in the latter group the effects on disease progression assessed by MRI and clinical measures.

  3. Current Status of Open Surgical Treatment Protocols for Subacromial Impingement Syndrome Associated with Rotator Tear

    Directory of Open Access Journals (Sweden)

    Oktay Gazi

    2012-06-01

    Full Text Available Objective: The aim of this study was to evaluate the recent treatment protocols for Neer stage III subacromial impingement syndrome with open anterior acromioplasty and rotator cuff repair. Material and Methods: Twenty-two patients (8 males, 14 females; mean age: 52.9±10.2 who were diagnosed with a rotator cuff tear based on clinical and radiological findings between 2009 and 2010 participated in the study.. We used the open surgical decompression technique which was previously described by Neer. The ruptured tendon ends were isolated and were fixed to the bones with appropriate suture anchors and transosseoz sutures. Preoperative, postoperative and the final follow-up Constant and UCLA shoulder scores were evaluated. Results: The mean preoperative Constant score was 34.4±6.6 and UCLA score was 13.8±3.3. The mean postoperative Constant score was 73±7.6 and UCLA score was 31.7±3.3. Significant improvement was observed in postoperative shoulder scores (p<0.01 and postoperative shoulder range of motion in all patients (p<0.01. Conclusion: Currently, clinical and functional results of open and arthroscopic subacromial rotator cuff decompression are similar. However, many surgeons prefer the open method and achieve successful results. (The Me di cal Bul le tin of Ha se ki 2012; 50: 59-63

  4. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research to qu...... the statistical principles for trial protocols in terms of design, analysis, and reporting of findings.......In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research...

  5. Central blood pressure and pulse wave velocity: relationship to target organ damage and cardiovascular morbidity-mortality in diabetic patients or metabolic syndrome. An observational prospective study. LOD-DIABETES study protocol.

    Science.gov (United States)

    Gómez-Marcos, Manuel A; Recio-Rodríguez, José I; Rodríguez-Sánchez, Emiliano; Castaño-Sánchez, Yolanda; de Cabo-Laso, Angela; Sánchez-Salgado, Benigna; Rodríguez-Martín, Carmela; Castaño-Sánchez, Carmen; Gómez-Sánchez, Leticia; García-Ortiz, Luis

    2010-03-18

    Diabetic patients show an increased prevalence of non-dipping arterial pressure pattern, target organ damage and elevated arterial stiffness. These alterations are associated with increased cardiovascular risk.The objectives of this study are the following: to evaluate the prognostic value of central arterial pressure and pulse wave velocity in relation to the incidence and outcome of target organ damage and the appearance of cardiovascular episodes (cardiovascular mortality, myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus or metabolic syndrome. This is an observational prospective study with 5 years duration, of which the first year corresponds to patient inclusion and initial evaluation, and the remaining four years to follow-up. The study will be carried out in the urban primary care setting. Consecutive sampling will be used to include patients diagnosed with type 2 diabetes between 20-80 years of age. A total of 110 patients meeting all the inclusion criteria and none of the exclusion criteria will be included. Patient age and sex, family and personal history of cardiovascular disease, and cardiovascular risk factors. Height, weight, heart rate and abdominal circumference. Laboratory tests: hemoglobin, lipid profile, creatinine, microalbuminuria, glomerular filtration rate, blood glucose, glycosylated hemoglobin, blood insulin, fibrinogen and high sensitivity C-reactive protein. Clinical and 24-hour ambulatory (home) blood pressure monitoring and self-measured blood pressure. Common carotid artery ultrasound for the determination of mean carotid intima-media thickness. Electrocardiogram for assessing left ventricular hypertrophy. Ankle-brachial index. Retinal vascular study based on funduscopy with non-mydriatic retinography and evaluation of pulse wave morphology and pulse wave velocity using the SphygmoCor system. The medication used for diabetes, arterial hypertension and hyperlipidemia will be registered, together

  6. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    (rigorous) protocol writing too troublesome, will realize that they have already written the first half of the final paper if they follow these recommendations; authors simply need to change the protocols future tense into past tense. Thus, the aim of this clinical commentary is to describe and explain...

  7. Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Garland Eric L

    2009-07-01

    Full Text Available Abstract Background Irritable bowel syndrome (IBS, a functional bowel disorder with symptoms of abdominal pain and disturbed defecation experienced by 10% of U.S. adults, results in significant disability, impaired quality of life, and health-care burden. Conventional medical care focusing on pharmacological approaches, diet, and lifestyle management has been partially effective in controlling symptoms. Behavioral treatments, such as cognitive-behavioral therapy and hypnosis, are promising. This paper describes an on-going feasibility study to assess the efficacy of mindfulness training, a behavioral treatment involving directing and sustaining attention to present-moment experience, for the treatment of IBS. Methods/Design The study design involves randomization of adult women with IBS according to Rome II criteria, to either an eight-week mindfulness training group (based on a Mindfulness-based Stress Reduction [MBSR] format or a previously validated IBS social-support group as an attention-control condition. The primary hypothesis is that, compared to Support Group participants, those in the Mindfulness Program will demonstrate significant improvement in IBS symptoms as measured by the IBS Symptom Severity Scale 1. Discussion 214 individuals have been screened for eligibility, of whom 148 were eligible for the study. Of those, 87 were enrolled, with 21 withdrawing after having given consent. 66 have completed or are in the process of completing the interventions. It is feasible to undertake a rigorous randomized clinical trial of mindfulness training for people with IBS, using a standardized MBSR protocol adapted for those experiencing IBS, compared to a control social-support group previously utilized in IBS studies. Trial Registration Clinical Trials.gov Identifier: NCT00680693

  8. Antiphospholipid syndrome: A case study

    International Nuclear Information System (INIS)

    Davies, T.

    1998-01-01

    Full text: A forty-two-year-old male presented to the Royal Adelaide Hospital with symptoms of increasing shortness of breath, swelling in both ankles, petechial rash and blood in his sputum. Initial investigations showed cardiomegaly, right ventricular hypertrophy, patchy lung infiltrates, a platelet count of 1500 and a clotting time of 60 seconds. A V/Q scan indicated a high probability of pulmonary embolism. Further investigations showed that the patient was positive for lupus anticoagulant and cardiolipin antibodies. A diagnosis of primary antiphospholipid syndrome was made. The patient''s high risk of strokes and hemorrhaging prompted investigation by a 99 mTc-HMPAO brain scan. Further V/Q scans were performed to follow up the initial finding of multiple pulmonary embolism and a R-L shunt study was performed to investigate a left subclavian murmur. The patient was admitted for four weeks and began treatment which included cyclaphosphamide, corticosteroids and plasmaphoresis and was discharged when stable. Over the next six months he was re admitted three times for relapse of antiphospholipid syndrome. On his fourth admission he collapsed and died five hours after admission. Cause of death was due to cardiac arrhythmia secondary to severe right ventricular hypertrophy and dilation. The effects of antiphospholipid syndrome was believed to be responsible for this outcome

  9. Antiphospholipid syndrome: A case study

    Energy Technology Data Exchange (ETDEWEB)

    Davies, T. [Royal Adelaide Hospital, Adelaide, SA (Australia). Department of Nuclear Medicine

    1998-03-01

    Full text: A forty-two-year-old male presented to the Royal Adelaide Hospital with symptoms of increasing shortness of breath, swelling in both ankles, petechial rash and blood in his sputum. Initial investigations showed cardiomegaly, right ventricular hypertrophy, patchy lung infiltrates, a platelet count of 1500 and a clotting time of 60 seconds. A V/Q scan indicated a high probability of pulmonary embolism. Further investigations showed that the patient was positive for lupus anticoagulant and cardiolipin antibodies. A diagnosis of primary antiphospholipid syndrome was made. The patient``s high risk of strokes and hemorrhaging prompted investigation by a {sup 99}mTc-HMPAO brain scan. Further V/Q scans were performed to follow up the initial finding of multiple pulmonary embolism and a R-L shunt study was performed to investigate a left subclavian murmur. The patient was admitted for four weeks and began treatment which included cyclaphosphamide, corticosteroids and plasmaphoresis and was discharged when stable. Over the next six months he was re admitted three times for relapse of antiphospholipid syndrome. On his fourth admission he collapsed and died five hours after admission. Cause of death was due to cardiac arrhythmia secondary to severe right ventricular hypertrophy and dilation. The effects of antiphospholipid syndrome was believed to be responsible for this outcome.

  10. Preservation of the roots--management and prevention protocols for cracked tooth syndrome.

    Science.gov (United States)

    Zimet, P O; Endo, C

    2000-10-01

    It is essential that symptomatic fractures of teeth be suitably diagnosed to prevent propagation of the fracture and continuation of the symptoms. The importance of understanding the mechanism and progression of fractures within teeth is essential when considering the management of fractures within teeth. The relation of the fracture line to the pulp, periodontal ligament and root will influence the management protocols for the involved teeth. When does a Cracked Tooth Syndrome (CTS) become a cracked tooth i.e., unrestorable? Consideration is also required regarding when endodontic treatment should be commenced. Further, suitable-coronal restoration of teeth is required to prevent propagation of the fracture line and persistence of the symptoms. Patients diagnosed with CTS should be counselled in strategies to prevent CTS in other teeth.

  11. Influence of quality of care and individual patient characteristics on quality of life and return to work in survivors of the acute respiratory distress syndrome: protocol for a prospective, observational, multi-centre patient cohort study (DACAPO).

    Science.gov (United States)

    Brandstetter, Susanne; Dodoo-Schittko, Frank; Blecha, Sebastian; Sebök, Philipp; Thomann-Hackner, Kathrin; Quintel, Michael; Weber-Carstens, Steffen; Bein, Thomas; Apfelbacher, Christian

    2015-12-17

    Health-related quality of life (HRQoL) and return to work are important outcomes in critical care medicine, reaching beyond mortality. Little is known on factors predictive of HRQoL and return to work in critical illness, including the acute respiratory distress syndrome (ARDS), and no evidence exists on the role of quality of care (QoC) for outcomes in survivors of ARDS. It is the aim of the DACAPO study ("Surviving ARDS: the influence of QoC and individual patient characteristics on quality of life") to investigate the role of QoC and individual patient characteristics on quality of life and return to work. A prospective, observational, multi-centre patient cohort study will be performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyse a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. QoC will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (HRQoL and return to work) will be assessed by self-report questionnaires. Further data collection includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of QoC and individual patient characteristics on outcomes, taking the cluster structure of the data into account. By obtaining comprehensive data at patient and hospital level using a prospective multi-centre design, the DACAPO-study is the first study investigating the influence of QoC on individual outcomes of ARDS survivors.

  12. Prophylactic aortic root surgery in patients with Marfan syndrome : 10 years' experience with a protocol based on body surface area

    NARCIS (Netherlands)

    Aalberts, Jan J. J.; van Tintelen, J. Peter; Hillege, Hans L.; Boonstra, Piet W.; van den Berg, Maarten P.; Waterbolk, T

    Background: Current guidelines recommending prophylactic aortic root replacement in Marfan syndrome are based on absolute diameters of the aortic root. However, aortic root diameter is a function of body surface area (BSA). Here, we report our experience with a protocol for prophylactic aortic root

  13. Impact of aerobic exercise training during chemotherapy on cancer related cognitive impairments in patients suffering from acute myeloid leukemia or myelodysplastic syndrome - Study protocol of a randomized placebo-controlled trial.

    Science.gov (United States)

    Zimmer, P; Oberste, M; Bloch, W; Schenk, A; Joisten, N; Hartig, P; Wolf, F; Baumann, F T; Garthe, A; Hallek, M; Elter, T

    2016-07-01

    Cancer related cognitive impairments (CRCI) are frequently reported by patients prior to, during and after medical treatment. Although this cognitive decline severely affects patients' quality of life, little is known about effective treatments. Exercise programs represent a promising supportive strategy in this field. However, evidence is sparse and existing studies display methodological limitations. In the planned study, 83 men and women newly diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) will be randomized into one of three treatment groups. During 4weeks of induction chemotherapy with Anthracycline and Cytarabin patients allocated to exercise group will cycle 3×/week for 30min at moderate to vigorous intensity on an ergometer. Patients allocated to placebo group will receive a supervised myofascial release training (3×/week, approx. 30min) and patients at control group will get usual care. As primary endpoints a cognitive test battery will be conducted measuring performances depending on verbal/spatial memory and executive functioning. Secondary endpoints will be self-perceived cognitive functioning, as well as neurotrophic and inflammatory serum markers. All assessments will be conducted immediately after hospitalization and before chemotherapy is commenced, immediately before discharge of hospital after 4-5weeks as well as before continuing medical treatment 3-4weeks after discharge. This will be the first study investigating the impact of an aerobic exercise training on CRCI in AML/MDS patients. We hope that the study design and the state-of-the-art assessments will help to increase knowledge about CRCI in general and exercise as potential treatment option in this under investigated population. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Comparison of acupuncture pretreatment followed by letrozole versus letrozole alone on live birth in anovulatory infertile women with polycystic ovary syndrome: a study protocol for a randomised controlled trial

    Science.gov (United States)

    Li, Juan; Ng, Ernest Hung Yu; Stener-Victorin, Elisabet; Hu, Zhenxing; Wu, Wanting; Lai, Maohua; Wu, Taixiang; Ma, Hongxia

    2016-01-01

    Introduction The high prevalence of insulin resistance in women with polycystic ovary syndrome (PCOS) is considered to be one of the major pathophysiological changes in PCOS that leads to anovulatory infertility. We hypothesise that electroacupuncture pretreatment improves insulin sensitivity and leads to a higher ovulation rate and greater chances of live birth after the induction of ovulation. The effect of electroacupuncture pretreatment followed by ovulation induction in women with anovulatory PCOS has not been investigated before, and we present here a randomised controlled trial to test this hypothesis by comparing electroacupuncture pretreatment followed by letrozole versus letrozole alone in anovulatory women with PCOS. Methods/analysis This is a multicentre, randomised,and controlled trial. A total of 384 patients will be enrolled in this study and will be randomly allocated by a central randomisation system to the treatment group or the control group in a 1:1 ratio. The treatment group will undergo 16 weeks of electroacupuncture pretreatment followed by 4 cycles of letrozole, and the control group will only undergo 4 cycles of letrozole. The primary outcome will be the live birth rate. All statistical analyses will be performed using the SPSS program V.21.0 (SPSS, Chicago, Illinois, USA), and a p value <0.05 will be considered statistically significant. Ethics/dissemination This study has been approved by the ethics committees of each participating centre. Written consent will be obtained from each patient and her husband before any study procedure is performed. Adverse events will be categorised, and the percentage of patients experiencing adverse events or serious adverse events during the treatment period will be documented. The results of this trial will be disseminated in peer-reviewed journals and presented at international meetings. Trial registration number NCT02491333. PMID:27855085

  15. Extraction protocols for orthodontic treatment: A retrospective study

    Directory of Open Access Journals (Sweden)

    Vaishnevi N Thirunavukkarasu

    2016-01-01

    Full Text Available Background and Objectives: Various extraction protocols have been followed for successful orthodontic treatment. The purpose of this study was to evaluate the extraction protocols in patients who had previously undergone orthodontic treatment and also who had reported for continuing orthodontic treatment from other clinics. Materials and Methods: One hundred thirty eight patients who registered for orthodontic treatment at the Faculty of Dentistry were divided into 10 extraction protocols based on the Orthodontic treatment protocol given by Janson et al. and were evaluated for statistical significance. Results: The descriptive statistics of the study revealed a total of 40 (29% patients in protocol 1, 43 (31.2% in protocol 2, 18 (13% in protocol 3, 16 (11.6% in protocol 5, and 12 (8.7% in Type 3 category of protocol 9. The Type 3 category in protocol 9 was statistically significant compared to other studies. Midline shift and collapse of the arch form were noticed in these individuals. Conclusion: Extraction of permanent teeth such as canine and lateral incisors without rational reasons could have devastating consequences on the entire occlusion. The percentage of cases wherein extraction of permanent teeth in the crowded region was adopted as a treatment option instead of orthodontic treatment is still prevalent in dental practice. The shortage of orthodontists in Malaysia, the long waiting period, and lack of subjective need for orthodontic treatment at an earlier age group were the reasons for the patient's to choose extraction of the mal-aligned teeth such as the maxillary canine or maxillary lateral incisors.

  16. Radioisotope studies in algodystrophic syndrome

    Energy Technology Data Exchange (ETDEWEB)

    De Rossi, G.; Focacci, C.; Salvatori, M.; Regi, M.; Bertolini, C.; Piazzini, D.; Sterzi, S.; Greco, F.

    1983-10-01

    A total of 22 patients with algodystrophic syndrome was studied, treated with calcitonin (n = 11) or magnetotherapy (n = 11). Scintigraphy was performed before and 3 months after the onset of therapy. The ratio between the counts on the pathologic segment (P) vs. a contralateral normal area (N) was calculated. Pre-/posttherapy P/N difference was found to correlate well with clinical improvement. On the basis of such a follow-up method calcitonin treatment seemed to achieve better results than magnetotherapy, at least in the first clinical stadium of the disease.

  17. Quantitative methods for studying design protocols

    CERN Document Server

    Kan, Jeff WT

    2017-01-01

    This book is aimed at researchers and students who would like to engage in and deepen their understanding of design cognition research. The book presents new approaches for analyzing design thinking and proposes methods of measuring design processes. These methods seek to quantify design issues and design processes that are defined based on notions from the Function-Behavior-Structure (FBS) design ontology and from linkography. A linkograph is a network of linked design moves or segments. FBS ontology concepts have been used in both design theory and design thinking research and have yielded numerous results. Linkography is one of the most influential and elegant design cognition research methods. In this book Kan and Gero provide novel and state-of-the-art methods of analyzing design protocols that offer insights into design cognition by integrating segmentation with linkography by assigning FBS-based codes to design moves or segments and treating links as FBS transformation processes. They propose and test ...

  18. Efficacy of the genetic sonogram in a stepwise sequential protocol for down syndrome screening.

    Science.gov (United States)

    Shamshirsaz, Alireza A; Ravangard, Samadh F; Turner, Garry; Borgida, Adam; Janicki, Mary Beth; Campbell, Winston A; Zelop, Carolyn; Shamshirsaz, Amirhoushang A; Spiel, Melissa; Prabulos, Anne Marie; Feldman, Deborah; Rodis, John; Ingardia, Charles J; Gurram, Padmalatha; Fuller, Kisti; Fang, Yu M; Benn, Peter; Egan, James F X

    2013-09-01

    The purpose of this study was to evaluate the efficacy of the genetic sonogram in Down syndrome screening for women who have received the stepwise sequential test. This retrospective cohort study included women with singleton pregnancies who underwent stepwise sequential (first-trimester combined and second-trimester serum) screening and then had a genetic sonogram between March 2005 and January 2010. Stepwise sequential Down syndrome risks were multiplied by either a positive or negative likelihood ratio based on the second-trimester sonographic findings to determine the final Down syndrome risk. A final Down syndrome risk of 1:270 or higher was considered screen positive. A total of 6286 women fulfilled our criteria, including 17 with Down syndrome-affected fetuses. After stepwise sequential testing, the Down syndrome detection rate was 88.2% (15 of 17), and after the genetic sonogram, there was a non-significant reduction in detection to 82.4% (14 of 17; P > .05). For the 6269 unaffected pregnancies, the genetic sonogram converted 58 screen-negative results (1%) to positive and 183 screen-positive results (3.1%) to negative. The net effect was a change in the false-positive rate from 6.2% (390 of 6269) after stepwise sequential screening to 4.2% (266 of 6269) after the genetic sonogram. The genetic sonogram should be applied cautiously for women who have received prior prenatal screening tests. Women with screen-positive results need to be counseled that a negative sonographic result can be falsely reassuring. Conversely, for women with screen-negative results who have a risk close to the cutoff, a sonographic examination could assist in the decision of whether to accept or reject amniocentesis.

  19. Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Vento, Giovanni; Pastorino, Roberta; Boni, Luca; Cota, Francesco; Carnielli, Virgilio; Cools, Filip; Dani, Carlo; Mosca, Fabio; Pillow, Jane; Polglase, Graeme; Tagliabue, Paolo; van Kaam, Anton H.; Ventura, Maria Luisa; Tana, Milena; Tirone, Chiara; Aurilia, Claudia; Lio, Alessandra; Ricci, Cinzia; Gambacorta, Alessandro; Consigli, Chiara; D'Onofrio, Danila; Gizzi, Camilla; Massenzi, Luca; Cardilli, Viviana; Casati, Alessandra; Bottino, Roberto; Pontiggia, Federica; Ciarmoli, Elena; Martinelli, Stefano; Ilardi, Laura; Colnaghi, Mariarosa; Matassa, Piero Giuseppe; Vendettuoli, Valentina; Villani, Paolo; Fusco, Francesca; Gazzolo, Diego; Ricotti, Alberto; Ferrero, Federica; Stasi, Ilaria; Magaldi, Rosario; Maffei, Gianfranco; Presta, Giuseppe; Perniola, Roberto; Messina, Francesco; Montesano, Giovanna; Poggi, Chiara; Giordano, Lucio; Roma, Enza; Grassia, Carolina; Ausanio, Gaetano; Sandri, Fabrizio; Mescoli, Giovanna; Giura, Francesco; Garani, Giampaolo; Solinas, Agostina; Lucente, Maria; Nigro, Gabriella; del Vecchio, Antonello; Petrillo, Flavia; Orfeo, Luigi; Grappone, Lidia; Quartulli, Lorenzo; Scorrano, Antonio; Messner, Hubert; Staffler, Alex; Gargano, Giancarlo; Balestri, Eleonora; Nobile, Stefano; Cacace, Caterina; Meli, Valerio; Dallaglio, Sara; Pasqua, Betta; Mattia, Loretta; Gitto, Eloisa; Vitaliti, Marcello; Re, Maria Paola; Vedovato, Stefania; Grison, Alessandra; Berardi, Alberto; Torcetta, Francesco; Guidotti, Isotta; di Fabio, Sandra; Maranella, Eugenia; Mondello, Isabella; Visentin, Stefano; Tormena, Francesca

    2016-01-01

    Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E

  20. A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Kinsella, Rita; Cowan, Sallie M; Watson, Lyn; Pizzari, Tania

    2017-01-01

    Subacromial pain syndrome (SPS) involving rotator cuff tendinopathy is a common cause of shoulder pain and disability. Evidence suggests that structured physiotherapy may be as effective as surgery in this condition with significant improvements demonstrated in trials involving scapular retraining, rotator cuff strengthening and flexibility exercises. Most published programs typically utilise isotonic concentric and/or eccentric strengthening modes. Recently, immediate analgesic effects and muscle strength gains following heavy-load isometric exercises in lower limb tendinopathy conditions have been observed. It is pertinent to ascertain whether such outcomes can be replicated in SPS/rotator cuff tendinopathy. The primary aim of this study is to establish the feasibility of undertaking a full-scale randomised controlled trial (RCT) that compares the effects of isometric, isotonic concentric and isotonic eccentric rotator cuff contractions when used as part of a semi-standardised exercise-based physiotherapy program in patients diagnosed with SPS. The secondary aim is to explore potential trends or treatment effects of the exercise intervention. Thirty-six participants diagnosed with SPS will be randomised to one of three intervention groups and undergo a one-on-one exercise-based physiotherapy intervention, involving scapular and rotator cuff muscle retraining and strengthening. Each group will utilise a different mode of rotator cuff strengthening-isometric, isotonic concentric or isotonic eccentric. Rotator cuff tendon responses to isometric loading are not yet established in the literature; hence, individualised, progressive loading will be used in this pilot study in accordance with symptoms. The intervention will involve two phases: during Phase 1 (weeks 1-6) participants undertake the active group-specific physiotherapy treatment; in Phase 2 (weeks 6-12), they undertake a progressive, but no longer group-specific exercise program. To determine feasibility, an

  1. Neurocutaneous syndrome: A prospective study

    Directory of Open Access Journals (Sweden)

    Radheshyam Purkait

    2011-01-01

    Full Text Available Background: Neurocutaneous syndromes (NCS are a group of genetic disorders that produce a variety of developmental abnormalities of the skin along with an increased risk of neurological complications. Cutaneous manifestations usually appear early in life and progress with time, but neurological features generally present at a later age. There is a paucity of data regarding the evolution of skin lesions and their correlation with the central nervous system involvement in children. Aim: The primary objective was to track the course of skin lesions in various forms of NCS in the pediatric age group. Our secondary aim was to assess whether there was any predictive value of the lesions in relation to the neurological manifestations. Materials and Methods: This prospective longitudinal study was conducted at a tertiary care pediatric dermatology referral clinic of the Institute of Child Health, Kolkata, West Bengal. Children between the age group 0 and 12 years were included in the study on the basis of standard diagnostic criteria for different NCS, during the period from March, 2000 to February, 2004, and each of the enrolled cases were followed up for a duration of six years. Results: The study population comprised of 67 children (35 boys, 32 girls.The mean age of presentation was 33.8±27.8 months (range 10 days to 111 months. The various forms of NCS observed was neurofibromatosis 1(NF1 (n=33, tuberous sclerosis complex (TSC (n=23, Sturge Weber syndrome (n=6, ataxia telangiectasia (n=2, PHACE syndrome (n=1, incontinentia pigmenti (n=1, and hypomelanosis of Ito (n=1. The presentations were varied, ranging from predominantly cutaneous to primarily neurological, depending on the disease entity and age group concerned. There was a significant increase in the number of café au lait macules (CALMs with time (P=0.0002 in NF1, unlike that of hypopigmented macules of TSC (P=0.15. Statistically, no relation was documented between the evolution of skin

  2. Identification of a research protocol to study orthodontic tooth movement

    Directory of Open Access Journals (Sweden)

    Annalisa Dichicco

    2014-06-01

    Full Text Available Aim: The orthodontic movement is associated with a process of tissue remodeling together with the release of several chemical mediators in periodontal tissues. Each mediator is a potential marker of tooth movement and expresses biological processes as: tissue inflammation and bone remodeling. Different amounts of every mediator are present in several tissues and fluids of the oral cavity. Therefore, there are different methods that allow sampling with several degrees of invasiveness. Chemical mediators are also substances of different molecular nature, and multiple kind of analysis methods allow detection. The purpose of this study was to draft the best research protocol for an optimal study on orthodontic movement efficiency. Methods: An analysis of the international literature have been made, to identify the gold standard of each aspect of the protocol: type of mediator, source and method of sampling and analysis method. Results: From the analysis of the international literature was created an original research protocol for the study and the assessment of the orthodontic movement, by using the biomarkers of the tooth movement. Conclusions: The protocol created is based on the choice of the gold standard of every aspect already analyzed in the literature and in existing protocols for the monitoring of orthodontic tooth movement through the markers of tooth movement. Clinical trials re required for the evaluation and validation of the protocol created.

  3. A multicenter study on Leigh syndrome

    DEFF Research Database (Denmark)

    Sofou, Kalliopi; De Coo, Irenaeus F M; Isohanni, Pirjo

    2014-01-01

    to thrive, brainstem lesions on neuroimaging and intensive care treatment were significantly associated with poorer survival. CONCLUSIONS: This is a multicenter study performed in a large cohort of patients with Leigh syndrome. Our data help define the natural history of Leigh syndrome and identify novel...

  4. Prader-Willi Syndrome: Two Case Studies.

    Science.gov (United States)

    Bahling, Elizabeth F.

    1979-01-01

    Prader-Willi Syndrome, also called "the eating disease", is a low-incidence handicap which cannot be diagnosed in infancy. Most adults reported in the literature are institutionalized and profoundly retarded. A study of the diagnosis and intervention of two Prader-Willi Syndrome children is presented. (Author/JKS)

  5. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research...

  6. Study Protocol – Metabolic syndrome, vitamin D and bone status in South Asian women living in Auckland, New Zealand: A randomised, placebo-controlled, double-blind vitamin D intervention

    Science.gov (United States)

    von Hurst, Pamela R; Stonehouse, Welma; Matthys, Christophe; Conlon, Cathryn; Kruger, Marlena C; Coad, Jane

    2008-01-01

    Background The identification of the vitamin D receptor in the endocrine pancreas suggests a role for vitamin D in insulin secretion. There is also some limited evidence that vitamin D influences insulin resistance, and thus the early stages of the development of type 2 diabetes. Methods Eighty-four women of South Asian origin, living in Auckland, New Zealand, were randomised to receive either a supplement (4000IU 25(OH)D3 per day) or a placebo for 6 months. At baseline, all participants were vitamin D deficient (serum 25(OH)D3 1.93) and/or hyperinsulinaemic, hyperglycemic or had clinical signs of dislipidaemia. Changes in HOMA-IR, lipids, parathyroid hormone, calcium and bone markers were monitored at 3 months and 6 months. Discussion This randomised, controlled trial will be the first to investigate the effect of vitamin D supplementation on insulin resistance in non-diabetic subjects. It will subsequently contribute to the growing body of evidence about the role of vitamin D in metabolic syndrome.Registered clinical. Trial registration Registered clinical trial – Registration No. ACTRN12607000642482 PMID:18667086

  7. Study Protocol – Metabolic syndrome, vitamin D and bone status in South Asian women living in Auckland, New Zealand: A randomised, placebo-controlled, double-blind vitamin D intervention

    Directory of Open Access Journals (Sweden)

    Kruger Marlena C

    2008-07-01

    Full Text Available Abstract Background The identification of the vitamin D receptor in the endocrine pancreas suggests a role for vitamin D in insulin secretion. There is also some limited evidence that vitamin D influences insulin resistance, and thus the early stages of the development of type 2 diabetes. Methods Eighty-four women of South Asian origin, living in Auckland, New Zealand, were randomised to receive either a supplement (4000IU 25(OHD3 per day or a placebo for 6 months. At baseline, all participants were vitamin D deficient (serum 25(OHD3 1.93 and/or hyperinsulinaemic, hyperglycemic or had clinical signs of dislipidaemia. Changes in HOMA-IR, lipids, parathyroid hormone, calcium and bone markers were monitored at 3 months and 6 months. Discussion This randomised, controlled trial will be the first to investigate the effect of vitamin D supplementation on insulin resistance in non-diabetic subjects. It will subsequently contribute to the growing body of evidence about the role of vitamin D in metabolic syndrome.Registered clinical. Trial registration Registered clinical trial – Registration No. ACTRN12607000642482

  8. Frequency of psychological alterations in primary antiphospholipid syndrome: preliminary study.

    Science.gov (United States)

    Sadetski, M; Tourinho Moretto, M L; Correia de Araujo, R P; de Carvalho, J F

    2018-04-01

    Objectives To detect the frequency of psychological alterations in primary antiphospholipid syndrome patients. Methods Thirty-six primary antiphospholipid syndrome patients were analyzed by a psychological interview using a standard protocol and review of medical charts. Clinical manifestations, associated comorbidities, antiphospholipid antibodies, and treatment were also evaluated. Results The mean age was 44.2 ± 10.8 years, 29 (80%) were women and 29 (80%) were of Caucasian race. The mean duration of disease was 7.3 ± 5.2 years. The frequency of the presence of psychological alterations was 97.1%. Family dependence was observed in 14 (40%), memory loss in 12 (34.3%), social losses in 12 (34.3%), sexual limitations in seven (20%), sadness in six (17.1%), severe speech limitation in four (11.4%), anxiety in three (8.6%), learning difficulty in two (5.7%), generalized phobia in two (5.7%), suicide ideation in one (2.6%), agoraphobia in one (2.6%), and obsessive-compulsive disorder in one (2.6%). Conclusion This study demonstrated that almost all primary antiphospholipid syndrome patients have psychological alterations. These data reinforce the need for psychological evaluation in primary antiphospholipid syndrome patients.

  9. Periodontal growth in areas of vascular malformation in patients with Sturge-Weber syndrome: a management protocol.

    Science.gov (United States)

    Pontes, Flávia Sirotheau Corrêa; Conte Neto, Nicolau; da Costa, Rodrigo Moreira Bringel; Loureiro, Arlison Miranda; do Nascimento, Liliane Silva; Pontes, Hélder Antônio Rebelo

    2014-01-01

    Sturge-Weber syndrome (SWS) is a very rare condition characterized by abnormal vascular formations that encompass several manifestations: cutaneous, neurologic, ocular, and oral. Neurologic conditions are the most important factor, especially epilepsy, which frequently leads patients to make use of anticonvulsants. These drugs are capable of inducing abnormal tissue growth in the oral cavity that can be situated over areas with vascular malformation, requiring special attention by the clinician. This report describes 1 case of SWS and performs a literature review of treatments for this condition, providing a protocol of treatment for these clinical situations.

  10. Potential hazards and technical considerations associated with myocardial cell transplantation protocols for ischemic myocardial syndrome.

    Science.gov (United States)

    Ben-Dor, Itsik; Fuchs, Shmuel; Kornowski, Ran

    2006-10-17

    Cell transplantation has recently emerged as a promising therapeutic approach to ischemic cardiomyopathy syndromes. Clinical studies suggest important benefits, including improved myocardial perfusion and function. The safety profile so far seems to be high overall, although the technique may harbor several adverse effects, such as ventricular arrhythmia, acceleration of atherosclerosis or restenosis, and induction of ischemic events. Multiple factors may affect the safety of cell infusion into the diseased heart, including the mode of delivery, the type of cells injected, compound characterization, and the heart status, function, and arrhythmogenic potential. Also, any adjunctive treatment used to enhance cellular homing and/or transdifferentiation increases the likelihood of unexpected local or systemic toxicity or side effects. In the present review, we discuss the potential hazards of this novel treatment and its relationship to technical considerations.

  11. Studying protocol-based pain management in the emergency department

    Directory of Open Access Journals (Sweden)

    Akkamahadevi Patil

    2017-01-01

    Full Text Available Background: Majority of the patients presenting to emergency department (ED have pain. ED oligoanalgesia remains a challenge. Aims: This study aims to study the effect of implementing a protocol-based pain management in the ED on (1 time to analgesia and (2 adequacy of analgesia obtained. Settings and Design: Cross-sectional study in the ED. Methods: Patients aged 18–65 years of age with pain of numeric rating scale (NRS ≥4 were included. A series of 100 patients presenting before introduction of the protocol-based pain management were grouped “pre-protocol,” and managed as per existing practice. Following this, a protocol for management of all patients presenting to ED with pain was implemented. Another series of 100 were grouped as “post-protocol” and managed as per the new pain management protocol. The data of patients from both the groups were collected and analyzed. Statistical Analysis Used: Descriptive statistical tests such as percentage, mean and standard deviation and inferential statistical tests such as Pearson coefficient, Student's t-test were applied. Differences were interpreted as significant when P < 0.05. Results: Mean time to administer analgesic was significantly lesser in the postprotocol group (preprotocol 20.30 min vs. postprotocol 13.05 min; P < 0.001. There was significant difference in the pain relief achieved (change in NRS between the two groups, with greater pain relief achieved in the postprotocol group (preprotocol group 4.6800 vs. postprotocol group 5.3600; P < 0.001. Patients' rating of pain relief (assessed on E5 scale was significantly higher in the postprotocol group (preprotocol 3.91 vs. postprotocol 4.27; P = 0.001. Patients' satisfaction (North American Spine Society scale with the overall treatment was also compared and found to be significantly higher in postprotocol group (mean: preprotocol 1.59 vs. postprotocol 1.39; P = 0.008. Conclusion: Protocol-based pain management provided timely and

  12. Oxygen Exposure Resulting in Arterial Oxygen Tensions Above the Protocol Goal Was Associated With Worse Clinical Outcomes in Acute Respiratory Distress Syndrome.

    Science.gov (United States)

    Aggarwal, Neil R; Brower, Roy G; Hager, David N; Thompson, B Taylor; Netzer, Giora; Shanholtz, Carl; Lagakos, Adrian; Checkley, William

    2018-04-01

    High fractions of inspired oxygen may augment lung damage to exacerbate lung injury in patients with acute respiratory distress syndrome. Participants enrolled in Acute Respiratory Distress Syndrome Network trials had a goal partial pressure of oxygen in arterial blood range of 55-80 mm Hg, yet the effect of oxygen exposure above this arterial oxygen tension range on clinical outcomes is unknown. We sought to determine if oxygen exposure that resulted in a partial pressure of oxygen in arterial blood above goal (> 80 mm Hg) was associated with worse outcomes in patients with acute respiratory distress syndrome. Longitudinal analysis of data collected in these trials. Ten clinical trials conducted at Acute Respiratory Distress Syndrome Network hospitals between 1996 and 2013. Critically ill patients with acute respiratory distress syndrome. None. We defined above goal oxygen exposure as the difference between the fraction of inspired oxygen and 0.5 whenever the fraction of inspired oxygen was above 0.5 and when the partial pressure of oxygen in arterial blood was above 80 mm Hg. We then summed above goal oxygen exposures in the first five days to calculate a cumulative above goal oxygen exposure. We determined the effect of a cumulative 5-day above goal oxygen exposure on mortality prior to discharge home at 90 days. Among 2,994 participants (mean age, 51.3 yr; 54% male) with a study-entry partial pressure of oxygen in arterial blood/fraction of inspired oxygen that met acute respiratory distress syndrome criteria, average cumulative above goal oxygen exposure was 0.24 fraction of inspired oxygen-days (interquartile range, 0-0.38). Participants with above goal oxygen exposure were more likely to die (adjusted interquartile range odds ratio, 1.20; 95% CI, 1.11-1.31) and have lower ventilator-free days (adjusted interquartile range mean difference of -0.83; 95% CI, -1.18 to -0.48) and lower hospital-free days (adjusted interquartile range mean difference of -1.38; 95

  13. Oral appliances and maxillomandibular advancement surgery : An alternative treatment protocol for the obstructive sleep apnea-hypopnea syndrome

    NARCIS (Netherlands)

    Hoekema, A; de Lange, J; Stegenga, B; de Bont, LGM

    Purpose: The present study comprises a retrospective evaluation of the potential application of mandibular repositioning appliance (MRA) therapy preceding maxillomandibular advancement (MMA) surgery in the treatment of the Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). Our initial experiences

  14. Automated extraction protocol for quantification of SARS-Coronavirus RNA in serum: an evaluation study

    Directory of Open Access Journals (Sweden)

    Lui Wing-bong

    2006-02-01

    Full Text Available Abstract Background We have previously developed a test for the diagnosis and prognostic assessment of the severe acute respiratory syndrome (SARS based on the detection of the SARS-coronavirus RNA in serum by real-time quantitative reverse transcriptase polymerase chain reaction (RT-PCR. In this study, we evaluated the feasibility of automating the serum RNA extraction procedure in order to increase the throughput of the assay. Methods An automated nucleic acid extraction platform using the MagNA Pure LC instrument (Roche Diagnostics was evaluated. We developed a modified protocol in compliance with the recommended biosafety guidelines from the World Health Organization based on the use of the MagNA Pure total nucleic acid large volume isolation kit for the extraction of SARS-coronavirus RNA. The modified protocol was compared with a column-based extraction kit (QIAamp viral RNA mini kit, Qiagen for quantitative performance, analytical sensitivity and precision. Results The newly developed automated protocol was shown to be free from carry-over contamination and have comparable performance with other standard protocols and kits designed for the MagNA Pure LC instrument. However, the automated method was found to be less sensitive, less precise and led to consistently lower serum SARS-coronavirus concentrations when compared with the column-based extraction method. Conclusion As the diagnostic efficiency and prognostic value of the serum SARS-CoV RNA RT-PCR test is critically associated with the analytical sensitivity and quantitative performance contributed both by the RNA extraction and RT-PCR components of the test, we recommend the use of the column-based manual RNA extraction method.

  15. Protocols to Study Growth and Metabolism in Drosophila.

    Science.gov (United States)

    Strassburger, Katrin; Teleman, Aurelio A

    2016-01-01

    Signaling pathways such as the insulin/insulin-like growth factor pathway concurrently regulate organismal growth and metabolism. Drosophila has become a popular model system for studying both organismal growth and metabolic regulation. Care must be taken, however, when assessing such phenotypes because they are quantitative in nature, and influenced by environment. This chapter first describes how to control animal age and nutrient availability, since growth and metabolism are sensitive to these parameters. It then provides protocols for measuring tissue growth, cell size, and metabolic parameters such as stored lipids and glycogen, and circulating sugars.

  16. A study to determine the effectiveness of core stabilisation exercises in the treatment of patellofemoral pain syndrome

    OpenAIRE

    2010-01-01

    M.Tech. This study compared the effectiveness of two different Chiropractic treatment protocols in the treatment of patellofemoral pain syndrome. This was done in order to establish whether or not core stabilisation exercises play a role in the treatment of patellofemoral pain syndrome. Thirty participants were used for this study. They were randomly placed into two groups namely; group 1 and group 2. Group 1 received strengthening exercises of the quadriceps muscle group and stretching ex...

  17. Reye's Syndrome: A Review of Research Studies.

    Science.gov (United States)

    Lopez, Thomas P.; And Others

    1982-01-01

    Clinical and pathological studies of Reye's syndrome indicate that symptoms range from influenza-related encephalitis-type disease to cranial pressure, cerebral edema, hemorrhage, and coma. Biochemical research on the blood, ammonia, and the liver is increasing in sophistication, and hopes for future insight into the etiology of Reye's syndrome…

  18. Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

    Science.gov (United States)

    Reveiz, Ludovic; Haby, Michelle M; Martínez-Vega, Ruth; Pinzón-Flores, Carlos E; Elias, Vanessa; Smith, Emma; Pinart, Mariona; Broutet, Nathalie; Becerra-Posada, Francisco; Aldighieri, Sylvain; Van Kerkhove, Maria D

    2017-01-01

    Given the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV. We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols. Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design. Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at

  19. Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

    Directory of Open Access Journals (Sweden)

    Ludovic Reveiz

    Full Text Available Given the severity and impact of the current Zika virus (ZIKV outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV.We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols.Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome. Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design.Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to

  20. Viewing Social Scenes: A Visual Scan-Path Study Comparing Fragile X Syndrome and Williams Syndrome

    Science.gov (United States)

    Williams, Tracey A.; Porter, Melanie A.; Langdon, Robyn

    2013-01-01

    Fragile X syndrome (FXS) and Williams syndrome (WS) are both genetic disorders which present with similar cognitive-behavioral problems, but distinct social phenotypes. Despite these social differences both syndromes display poor social relations which may result from abnormal social processing. This study aimed to manipulate the location of…

  1. Work-related psychosocial factors and onset of metabolic syndrome among workers: a systematic review and meta-analysis protocol.

    Science.gov (United States)

    Sakuraya, Asuka; Watanabe, Kazuhiro; Kawakami, Norito; Imamura, Kotaro; Ando, Emiko; Asai, Yumi; Eguchi, Hisashi; Kobayashi, Yuka; Nishida, Norimitsu; Arima, Hideaki; Shimazu, Akihito; Tsutsumi, Akizumi

    2017-06-22

    Metabolic syndrome is an important public health target because of its high prevalence worldwide. Work-related psychosocial factors have been identified as determinants of metabolic syndrome components. However, there have been no systematic reviews or meta-analyses conducted to evaluate the relationship between work-related psychosocial factors and metabolic syndrome as an aggregated cluster. The aim of this study is to examine this association from published prospective studies. The systematic review and meta-analysis will be conducted using published studies that will be identified from electronic databases (ie, PubMed, EMBASE, PsycINFO, PsycARTICLES and Japan Medical Abstracts Society). Studies that (1) examined the association between work-related psychosocial factors and the onset of metabolic syndrome, (2) had a longitudinal or prospective cohort design, (3) were conducted among workers, (4) provided sufficient data for calculating ORs or relative risk with a 95% CI, (5) were published as original articles written in English or Japanese, and (6) having been published until the end of 2016 will be included. Study selection, data collection, quality assessment and statistical syntheses will be conducted based on discussions among investigators. Ethics approval was not required for this study because it was based on published studies. The results and findings of this study will be submitted and published in a scientific peer-reviewed journal. The findings from this study could be useful for assessing metabolic syndrome risk factors in the workplace, and determining approaches for prevention of metabolic syndrome in the future. PROSPERO CRD42016039096 (http://www.crd.york.ac.uk/PROSPERO_REBRANDING/display_record.asp?ID=CRD42016039096). © 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.

  2. Pain, motion and function comparison of two exercise protocols for the rotator cuff and scapular stabilizers in patients with subacromial syndrome.

    Science.gov (United States)

    Vallés-Carrascosa, Eva; Gallego-Izquierdo, Tomás; Jiménez-Rejano, José Jesús; Plaza-Manzano, Gustavo; Pecos-Martín, Daniel; Hita-Contreras, Fidel; Achalandabaso Ochoa, Alexander

    2018-01-09

    Randomized clinical trial. Eccentric exercise (EE) was shown to be an effective treatment in tendinopathies. However, the evidence of its effectiveness in subacromial syndrome (SS) is scarce. Moreover, consensus has not been reached on whether best results for SS are obtained by means of EE with or without pain. The purpose of this is to compare the effect on pain, active range of motion (AROM), and shoulder function of an exercise protocol performed with pain shoulder function using the modified Constant-Murley Score (CMS) before and after intervention. All dependent variables improved significantly in both groups (P shoulder AROM. Furthermore, PEE does not provide greater benefits. Further studies are needed with long-term follow-up to reinforce these results. Copyright © 2017. Published by Elsevier Inc.

  3. Biomass to energy : GHG reduction quantification protocols and case study

    International Nuclear Information System (INIS)

    Reusing, G.; Taylor, C.; Nolan, W.; Kerr, G.

    2009-01-01

    With the growing concerns over greenhouses gases and their contribution to climate change, it is necessary to find ways of reducing environmental impacts by diversifying energy sources to include non-fossil fuel energy sources. Among the fastest growing green energy sources is energy from waste facilities that use biomass that would otherwise be landfilled or stockpiled. The quantification of greenhouse gas reductions through the use of biomass to energy systems can be calculated using various protocols and methodologies. This paper described each of these methodologies and presented a case study comparing some of these quantification methodologies. A summary and comparison of biomass to energy greenhouse gas reduction protocols in use or under development by the United Nations, the European Union, the Province of Alberta and Environment Canada was presented. It was concluded that regulatory, environmental pressures, and public policy will continue to impact the practices associated with biomass processing or landfill operations, such as composting, or in the case of landfills, gas collection systems, thus reducing the amount of potential credit available for biomass to energy facility offset projects. 10 refs., 2 tabs., 6 figs

  4. [Colombia 2015 National Mental Health Survey. Study Protocol].

    Science.gov (United States)

    Gómez-Restrepo, Carlos; de Santacruz, Cecilia; Rodriguez, María Nelcy; Rodriguez, Viviana; Tamayo Martínez, Nathalie; Matallana, Diana; Gonzalez, Lina M

    2016-12-01

    The 2015 National Mental Health Survey (NMHS) is the fourth mental survey conducted in Colombia, and is part of the National System of Surveys and Population Studies for health. A narrative description is used to explain the background, references, the preparation, and characteristics of the 2015 NMHS. The 2015 NMHS and its protocol emerge from the requirements that support the national and international policies related to mental health. Together with the Ministry of Health and Social Protection, the objectives, the collection tools, the sample, and the operational plan are defined. The main objective was to obtain updated information about the mental health, mental problems and disorders, accessibility to health services, and an evaluation of health conditions. Participants were inhabitants from both urban and rural areas, over 7 years old, and in whom the comprehension of social determinants and equity were privileged. An observational cross-sectional design with national, regional and age group representativity, was used. The age groups selected were 7-11, 12-17, and over 18 years old. The regions considered were Central, Orient, Atlantic, Pacific, and Bogota. The calculated sample had a minimum of 12,080 and a maximum of 14,496 participants. A brief summary of the protocol of the 2015 NMHS is presented. The full document with all the collection tools can be consulted on the Health Ministry webpage. Copyright © 2016. Publicado por Elsevier España.

  5. A Comparative Study of Various Routing Protocols in VANET

    OpenAIRE

    Kumar, Rakesh; Dave, Mayank

    2011-01-01

    Vehicular Ad Hoc Networks (VANET) is a subclass of Mobile ad hoc networks which provides a distinguished approach for Intelligent Transport System (ITS). The survey of routing protocols in VANET is important and necessary for smart ITS. This paper discusses the advantages / disadvantages and the applications of various routing protocols for vehicular ad hoc networks. It explores the motivation behind the designed, and traces the evolution of these routing protocols. F inally the paper conclud...

  6. Critical illness outcome study: an observational study of protocols and mortality in intensive care units

    Directory of Open Access Journals (Sweden)

    Sevransky J

    2011-09-01

    Full Text Available Naeem A Ali1, David Gutteridge2, Sajid Shahul3, William Checkley4, Jonathan Sevransky4, Greg S Martin2 1The Ohio State University Medical Center, Columbus, OH; 2Emory University, Atlanta, GA; 3Beth Israel Deaconess Medical Center, Boston, MA; 4Johns Hopkins University, Baltimore, MD, USA Abstract: Individual intensive care unit (ICU characteristics including staffing, expertise, continuity, and team structure, have been associated with patient outcomes. Separately, some aspects of care in ICUs have been implemented through treatment protocols. The United States Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS was designed to determine whether the extent of protocol use in ICUs is associated with hospital survival in a large number of US ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS steering committee. USCIITG-CIOS is a prospective, observational, ecological, multicentered study of mixed ICUs in the US. The data to be collected include organizational information for the ICU (eg, protocol availability and utilization, multidisciplinary staffing assessment, and patient level information (eg, demographics, acute and chronic medical conditions. The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high-protocol and low-protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize multivariable regression approaches to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. We anticipate at least 60 ICUs participating in USCIITG-CIOS to enroll approximately 6000 study subjects. USCIITG-CIOS is a multicenter study

  7. Mobile Ad Hoc Networks: A Comparative Study of QoS Routing Protocols

    OpenAIRE

    Gangwar, Sanjeev; Pal, Saurabh; Kumar, Krishan

    2012-01-01

    This Article presents a thorough overview of QoS routing metrics, resources and factors affecting performance of QoS routing protocols. The relative strength, weakness, and applicability of existing QoS routing protocols are also studied and compared. QoS routing protocols are classified according to the QoS metrics used type of QoS guarantee assured.

  8. Recommended Protocol for Round Robin Studies in Additive Manufacturing.

    Science.gov (United States)

    Moylan, Shawn; Brown, Christopher U; Slotwinski, John

    2016-03-01

    One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST's experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed.

  9. Study protocol for the Cities Changing Diabetes programme

    DEFF Research Database (Denmark)

    Napier, A David; Nolan, John J; Bagger, Malene

    2017-01-01

    . The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care......INTRODUCTION: Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many...... Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. ETHICS AND DISSEMINATION: The protocol steers the collection of primary and secondary data across the study sites. Research ethics...

  10. The effect of reduced disclusion time in the treatment of myofascial pain dysfunction syndrome using immediate complete anterior guidance development protocol monitored by digital analysis of occlusion.

    Science.gov (United States)

    Thumati, Prafulla; Manwani, Rakhi; Mahantshetty, Minal

    2014-10-01

    Chronic myofascial pain dysfunction syndrome (MPDS) has been a nightmare for patients suffering from it, who have been treated with various treatment options with varied outcomes. This population of patients has been neglected, due to nagging revisits to a clinician and decreased percentage of success. T-Scan-based immediate complete anterior guidance development (ICAGD) has been shown by a researcher to reduce the muscle hyperactivity consistent with MPDS. The purpose of this study is to evaluate the effect of reduced disclusion time in lateral excursions in treating the MPDS symptoms. Fifty-one myofascial pain patients with symptoms in the area of the head and neck region were treated with ICAGD. The quantified force and time data from T-Scan records were used to correct the prolonged disclusion time, and the subjects were assessed for the symptom relief. The Wilcoxon Signed Ranks Test was used for statistical analysis (P<0·05 denotes significant changes). The changes in disclusion time and intensity of various symptoms were found to be statistically significant (P<0·05) from Day 1 onwards, and patients were relieved of their symptoms after reduction of disclusion time of less than 0·5 seconds. The results clearly indicated that ICAGD protocol reduces musculoskeletal-based symptoms of MPDS patients, and this protocol can prove beneficial for the clinical treatment success.

  11. Constant round group key agreement protocols: A comparative study

    NARCIS (Netherlands)

    Makri, E.; Konstantinou, Elisavet

    2011-01-01

    The scope of this paper is to review and evaluate all constant round Group Key Agreement (GKA) protocols proposed so far in the literature. We have gathered all GKA protocols that require 1,2,3,4 and 5 rounds and examined their efficiency. In particular, we calculated each protocol’s computation and

  12. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cerritelli, Francesco; Cicchitti, Luca; Martelli, Marta; Barlafante, Gina; Renzetti, Cinzia; Pizzolorusso, Gianfranco; Lupacchini, Mariacristina; D'Orazio, Marianna; Marinelli, Benedetta; Cozzolino, Vincenzo; Fusilli, Paola; D'Incecco, Carmine

    2015-03-08

    Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy

  13. Monomelic neurogenic syndromes: a prospective study.

    Science.gov (United States)

    de Carvalho, Mamede; Swash, Michael

    2007-12-15

    Monomelic neurogenic syndromes are rare. Their classification and prognostic features have not been addressed in the European population. A prospective study of 17 patients with monomelic neurogenic amyotrophy, of upper or lower limb onset, with progression limited to one limb for three or more years. Clinical and neurophysiological studies were performed in the subsequent 3 or more years. Fifteen patients were of European origin and two were Asian. Those presenting with proximal monomelic weakness or with involvement of the posterior compartment of the lower leg showed no further progression after the initial period of development of the syndrome. Brisk reflexes in wasted muscles did not predict progression. Electromyographic signs of denervation in the opposite limb at presentation did not predict later progression. Transcranial magnetic stimulation (TMS) features of corticospinal dysfunction were a useful predictor of subsequent progression (p=0.01). One patient with lower limb onset developed conduction block with weakness in an upper limb nine years after presentation, and this upper limb weakness responded to IVIg therapy. This adult-onset European group of patients is different as compared with juvenile-onset Asian cases. The clinical syndromes appear heterogeneous, but neurophysiological investigations, in particular TMS, can be helpful in determining prognosis. Multifocal motor neuropathy should be considered when there is progression, even years after onset.

  14. Acute lymphoblastic leukemia in children with Down syndrome: A retrospective analysis from the Ponte di Legno study group

    NARCIS (Netherlands)

    T.D. Buitenkamp (Trudy); S. Izraeli (Shai); M. Zimmermann (Martin); E. Forestier (Erik); N.A. Heerema (Nyla); M.M. van den Heuvel-Eibrink (Marry); R. Pieters (Rob); C.M. Korbijn (Carin); L.B. Silverman (Lewis); K. Schmiegelow (Kjeld); D.-C. Liang (Der-Cheng); K. Horibe (Keizo); M. Aricò (Maurizio); A. Biondi (Andrea); G. Basso (Giuseppe); K.R. Rabin (Karin); M. Schrappe (Martin); G. Cario (Gunnar); G. Mann (Georg); M. Morak (Maria); R. Panzer-Grümayer (Renate); V. Mondelaers (Veerle); T. Lammens (Tim); H. Cavé (Hèléne); B. Stark (Batia); I. Ganmore (Ithamar); A.V. Moorman (Anthony); A. Vora (Ajay); S.P. Hunger (Stephen); C.H. Pui (Ching-Hon); C.G. Mullighan (Charles); A. Manabe (Atsushi); G. Escherich (Gabriele); J.R. Kowalczyk (Jerzy R.); J.A. Whitlock (James); C.M. Zwaan (Christian Michel)

    2014-01-01

    textabstractChildren with Down syndrome (DS) have an increased risk of B-cell precursor (BCP) acute lymphoblastic leukemia (ALL). The prognostic factors and outcome of DS-ALL patients treated in contemporary protocols are uncertain. We studied 653 DS-ALL patients enrolled in 16 international trials

  15. Study protocol: The Intensive Care Outcome Network ('ICON' study

    Directory of Open Access Journals (Sweden)

    Barber Vicki S

    2008-06-01

    Full Text Available Abstract Background Extended follow-up of survivors of ICU treatment has shown many patients suffer long-term physical and psychological consequences that affect their health-related quality of life. The current lack of rigorous longitudinal studies means that the true prevalence of these physical and psychological problems remains undetermined. Methods/Design The ICON (Intensive Care Outcome Network study is a multi-centre, longitudinal study of survivors of critical illness. Patients will be recruited prior to hospital discharge from 20–30 ICUs in the UK and will be assessed at 3, 6, and 12 months following ICU discharge for health-related quality of life as measured by the Short Form-36 (SF-36 and the EuroQoL (EQ-5D; anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS; and post traumatic stress disorder (PTSD symptoms as measured by the PTSD Civilian Checklist (PCL-C. Postal questionnaires will be used. Discussion The ICON study will create a valuable UK database detailing the prevalence of physical and psychological morbidity experienced by patients as they recover from critical illness. Knowledge of the prevalence of physical and psychological morbidity in ICU survivors is important because research to generate models of causality, prognosis and treatment effects is dependent on accurate determination of prevalence. The results will also inform economic modelling of the long-term burden of critical illness. Trial Registration ISRCTN69112866

  16. Inconsistent Reporting Between Meta-analysis Protocol and Publication - A Cross-Sectional Study.

    Science.gov (United States)

    Delgado, Alberto Falk; Delgado, Anna Falk

    2017-09-01

    Inconsistent reporting in published meta-analyses compared to registered protocol are poorly understood. The aim of the study was to assess inconsistencies between registered protocols and published reports among oncology drug meta-analyses. A cross-sectional study was performed including oncology drug meta-analyses published between January 1st and November 14th 2016 with a published protocol. Two investigators extracted data on: selection criteria, outcome(s) and statistical plan in protocol and manuscript, plus self-acknowledgement of inconsistent reporting between protocol and publication. Protocol registration was present in 19% (23/119) of all oncology drug meta-analyses. In meta-analyses with protocol (n=23), 70% (16/23) had issues with inconsistent reporting between protocol and published report concerning; inclusion criteria, comparator group, intervention, outcome (PICO) or statistical analysis. Self-acknowledgement of changes between protocol and publication was found in 50% (8/16). In meta-analyses with protocol, discrepancies between registered protocols and publications are frequent. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  17. How to design a (good) epidemiological observational study: epidemiological research protocol at a glance.

    Science.gov (United States)

    Fronteira, Ines

    2013-01-01

    In this article, we propose a general structure for designing a research protocol of an observational epidemiological study. We start by highlighting the importance of the research protocol, namely in accounting for some bias and guaranteeing methodologic rigor and study reproductability. Next, we reflect on some of the essential elements of a research protocol no matter its objective. We further present some specific issues to be included according to the type of study: cross-sectional, case-control and cohort.

  18. The gonadotropin-releasing hormone antagonist protocol--the protocol of choice for the polycystic ovary syndrome patient undergoing controlled ovarian stimulation

    DEFF Research Database (Denmark)

    Kol, Shahar; Homburg, Roy; Alsbjerg, Birgit

    2012-01-01

    Polycystic ovary syndrome (PCOS) patients are prone to develop ovarian hyperstimulation syndrome (OHSS), a condition which can be minimized or completely eliminated by the use of a gonadotropin-releasing hormone agonist (GnRHa) trigger. In this commentary paper, we maintain that the gonadotropin...

  19. A protocol for conducting rainfall simulation to study soil runoff.

    Science.gov (United States)

    Kibet, Leonard C; Saporito, Louis S; Allen, Arthur L; May, Eric B; Kleinman, Peter J A; Hashem, Fawzy M; Bryant, Ray B

    2014-04-03

    Rainfall is a driving force for the transport of environmental contaminants from agricultural soils to surficial water bodies via surface runoff. The objective of this study was to characterize the effects of antecedent soil moisture content on the fate and transport of surface applied commercial urea, a common form of nitrogen (N) fertilizer, following a rainfall event that occurs within 24 hr after fertilizer application. Although urea is assumed to be readily hydrolyzed to ammonium and therefore not often available for transport, recent studies suggest that urea can be transported from agricultural soils to coastal waters where it is implicated in harmful algal blooms. A rainfall simulator was used to apply a consistent rate of uniform rainfall across packed soil boxes that had been prewetted to different soil moisture contents. By controlling rainfall and soil physical characteristics, the effects of antecedent soil moisture on urea loss were isolated. Wetter soils exhibited shorter time from rainfall initiation to runoff initiation, greater total volume of runoff, higher urea concentrations in runoff, and greater mass loadings of urea in runoff. These results also demonstrate the importance of controlling for antecedent soil moisture content in studies designed to isolate other variables, such as soil physical or chemical characteristics, slope, soil cover, management, or rainfall characteristics. Because rainfall simulators are designed to deliver raindrops of similar size and velocity as natural rainfall, studies conducted under a standardized protocol can yield valuable data that, in turn, can be used to develop models for predicting the fate and transport of pollutants in runoff.

  20. Comparative Study on Various Authentication Protocols in Wireless Sensor Networks.

    Science.gov (United States)

    Rajeswari, S Raja; Seenivasagam, V

    2016-01-01

    Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated.

  1. [Cushing's syndrome: clinical study of fifteen cases].

    Science.gov (United States)

    Calvo Romero, J M; Morales Pérez, F; Alvarez Barreiro, J A; Diaz Pérez de Madrid, J

    1998-05-01

    To study the epidemiological and clinical features and diagnostic tests of Cushing's syndrome (CS) of non-iatrogenic etiology, because of there are few similar studies in the last ten years. Fifteen cases of CS were diagnosed from 1992 to 1997 at our hospital. We describe the epidemiological, clinical, biochemical, radiologic, therapeutic and evolutive characteristics. Both diabetes mellitus and hypertension were observed in 40% of patients. The frequency of etiologies was: Cushing's disease, 66.6%; ectopic ACTH syndrome, 13.3%; adrenal adenoma, 6.6%; adrenal carcinoma, 6.6%; and undiagnosed, 6.6%. The 24-hour urine free cortisol (UFC) and the overnight 1 mg oral dexamethasone suppression test yielded 93.3 and 100% diagnostic sensitivity for CS, respectively. The overnight 8 mg oral dexamethasone suppression test, the metyrapone test and the 7 mg intravenous dexmethasone test had 75, 50 and 60% diagnostic sensitivity for Cushing's disease, respectively. Ketoconazole treatment had success in to normalize the 24-hour UFC in all patients, except for the case of adrenal carcinoma. The Cushing's disease was the most common form of CS. The 24-hour UFC and overnight 1 mg oral dexamethasone suppression test were good screening studies. Ketoconazole was successful in normalizing the adrenal cortex function.

  2. Group schema therapy for eating disorders: study protocol.

    Science.gov (United States)

    Calvert, Fiona; Smith, Evelyn; Brockman, Rob; Simpson, Susan

    2018-01-01

    The treatment of eating disorders is a difficult endeavor, with only a relatively small proportion of clients responding to and completing standard cognitive behavioural therapy (CBT). Given the prevalence of co-morbidity and complex personality traits in this population, Schema Therapy has been identified as a potentially viable treatment option. A case series of Group Schema Therapy for Eating Disorders (ST-E-g) yielded positive findings and the study protocol outlined in this article aims to extend upon these preliminary findings to evaluate group Schema Therapy for eating disorders in a larger sample ( n  = 40). Participants undergo a two-hour assessment where they complete a number of standard questionnaires and their diagnostic status is ascertained using the Eating Disorder Examination. Participants then commence treatment, which consists of 25 weekly group sessions lasting for 1.5 h and four individual sessions. Each group consists of five to eight participants and is facilitated by two therapists, at least one of who is a registered psychologist trained on schema therapy. The primary outcome in this study is eating disorder symptom severity. Secondary outcomes include: cognitive schemas, self-objectification, general quality of life, self-compassion, schema mode presentations, and Personality Disorder features. Participants complete psychological measures and questionnaires at pre, post, six-month and 1-year follow-up. This study will expand upon preliminary research into the efficacy of group Schema Therapy for individuals with eating disorders. If group Schema Therapy is shown to reduce eating disorder symptoms, it will hold considerable promise as an intervention option for a group of disorders that is typically difficult to treat. ACTRN12615001323516. Registered: 2/12/2015 (retrospectively registered, still recruiting).

  3. Case study: BIM protocol for Skanska (Czech Republic

    Directory of Open Access Journals (Sweden)

    Kvirenc, Patrik

    2017-06-01

    Full Text Available The research paper introduces the problems of technical support of a model in projects in the area of BIM. Planning Requirements (BIM protocol describe the technical preparedness of models, data repletion, information sharing, communications and other processes in construction projects. This BIM protocol was developed for Skanska Inc. It consists of several parts, which are described in the article. At the introduction Skanska Inc. is presented together with its position in the area of BIM in the Czech market. The research analyzed the document itself, including its annexes. Another section is devoted to the importance of BIM protocol in project management of company Skanska. The document was prepared in cooperation with Skanska Inc. It applies only to commercial and residential projects in the area of building construction.

  4. Older Persons’ Transitions in Care (OPTIC: a study protocol

    Directory of Open Access Journals (Sweden)

    Cummings Greta G

    2012-12-01

    Full Text Available Abstract Background Changes in health status, triggered by events such as infections, falls, and geriatric syndromes, are common among nursing home (NH residents and necessitate transitions between NHs and Emergency Departments (EDs. During transitions, residents frequently experience care that is delayed, unnecessary, not evidence-based, potentially unsafe, and fragmented. Furthermore, a high proportion of residents and their family caregivers report substantial unmet needs during transitions. This study is part of a program of research whose overall aim is to improve quality of care for frail older adults who reside in NHs. The purpose of this study is to identify successful transitions from multiple perspectives and to identify organizational and individual factors related to transition success, in order to inform improvements in care for frail elderly NH residents during transitions to and from acute care. Specific objectives are to: 1. define successful and unsuccessful elements of transitions from multiple perspectives; 2. develop and test a practical tool to assess transition success; 3. assess transition processes in a discrete set of transfers in two study sites over a one year period; 4. assess the influence of organizational factors in key practice locations, e.g., NHs, emergency medical services (EMS, and EDs, on transition success; and 5. identify opportunities for evidence-informed management and quality improvement decisions related to the management of NH – ED transitions. Methods/Design This is a mixed-methods observational study incorporating an integrated knowledge translation (IKT approach. It uses data from multiple levels (facility, care unit, individual and sources (healthcare providers, residents, health records, and administrative databases. Discussion Key to study success is operationalizing the IKT approach by using a partnership model in which the OPTIC governance structure provides for team decision-makers and

  5. Assessing the feasibility, acceptability, and potential effectiveness of a behavioral-automaticity focused lifestyle intervention for African Americans with metabolic syndrome: The Pick two to Stick to protocol

    Directory of Open Access Journals (Sweden)

    Heather Fritz

    2017-09-01

    Full Text Available Background: Metabolic syndrome (MetS significantly increases the risk of developing diabetes and cardiovascular disease. Being physically active and eating a healthy diet can reduce MetS risk factors. Too frequently, however, studies report that the effects of interventions targeting those factors are not maintained once interventions are withdrawn. A potential solution to the problem is targeting behavioral automaticity (habit-development to aid in initiation and maintenance of health-behavior changes. The Pick two to Stick To (P2S2, is an 8-week, theory-based hybrid (face-to-face/telecoaching habit focused lifestyle intervention designed to increase healthful physical activity and dietary behavioral automaticity. The purpose of this article is to describe the rationale and protocol for evaluating the P2S2 program's feasibility, acceptability and potential effectiveness. Methods: Using a prospective, non-comparative design, the P2S2 program will be implemented by trained occupational therapy ‘coaches’ to 40 African Americans aged 40 and above with MetS recruited from the emergency department. Semi-structured interviews with participants, bi-weekly research meetings with study staff, and observations of intervention delivery will provide data for a process evaluation. Estimates of effectiveness include weight, blood pressure, waist circumference, BMI, and behavioral automaticity measures that will be collected at baseline and week 20. Conclusion: The P2S2 program could facilitate the development of healthful dietary and physical activity habits in an underserved population. Whether interventions aimed at changing habits can feasibly influence this automaticity, particularly for high-risk, low resource communities where other barriers exist, is not known. This pilot study, therefore, will fill an important gap, providing insight to inform subsequent trials. Keywords: Habits, Behavioral automaticity, Health behavior, Metabolic syndrome

  6. Irritable bowel syndrome is positively related to metabolic syndrome: a population-based cross-sectional study.

    Directory of Open Access Journals (Sweden)

    Yinting Guo

    Full Text Available Irritable bowel syndrome is a common gastrointestinal disorder that may affect dietary pattern, food digestion, and nutrient absorption. The nutrition-related factors are closely related to metabolic syndrome, implying that irritable bowel syndrome may be a potential risk factor for metabolic syndrome. However, few epidemiological studies are available which are related to this potential link. The purpose of this study is to determine whether irritable bowel syndrome is related to metabolic syndrome among middle-aged people. We designed a cross-sectional study of 1,096 subjects to evaluate the relationship between irritable bowel syndrome and metabolic syndrome and its components. Diagnosis of irritable bowel syndrome was based on the Japanese version of the Rome III Questionnaire. Metabolic syndrome was defined according to the criteria of the American Heart Association scientific statements of 2009. Dietary consumption was assessed via a validated food frequency questionnaire. Principal-components analysis was used to derive 3 major dietary patterns: "Japanese", "sweets-fruits", and "Izakaya (Japanese Pub "from 39 food groups. The prevalence of irritable bowel syndrome and metabolic syndrome were 19.4% and 14.6%, respectively. No significant relationship was found between the dietary pattern factor score tertiles and irritable bowel syndrome. After adjustment for potential confounders (including dietary pattern, the odds ratio (95% confidence interval of having metabolic syndrome and elevated triglycerides for subjects with irritable bowel syndrome as compared with non-irritable bowel syndrome are 2.01(1.13-3.55 and 1.50(1.03-2.18, respectively. Irritable bowel syndrome is significantly related to metabolic syndrome and it components. This study is the first to show that irritable bowel syndrome was significantly related to a higher prevalence of metabolic syndrome and elevated triglycerides among an adult population. The findings suggest that

  7. [Atypical Guillain-Barre syndrome clustering: is it necessary to reconsider the diagnostic criteria and microbiological protocol?

    Science.gov (United States)

    Dominguez-Mayoral, A; Gutierrez, C; Lopez-Dominguez, J M; Eichau, S; Abril, J; Navarro-Mascarell, G; Quesada-Garcia, M A; Ramos, M; Alvarez-Lopez, M; Menendez-De Leon, C; Izquierdo, G

    2017-05-01

    Guillain-Barre syndrome is classically defined as a symmetrical ascending acute polyradiculoneuropathy, although there are atypical variants that make diagnosis difficult. The medical data of six patients in our hospital area are collected during the first quarter of 2013. Lumbar punctures, imaging, neurophysiological studies, ganglioside antibodies and serologies have been proposed in all cases. We focus on the atypical features as late hyporeflexia, increased frequency of asymmetry and distal paresis and initial fever. From a neurophysiological point of view, all patients presented sensorimotor axonal forms. The most consistent datas in early studies is the F wave's alteration. A Miller Fisher variant associated with faciocervicobraquial paresis and cerebral reversible vasoconstriction syndrome has been detected. A bilateral brachial paresis and lumbar polyradiculopathy in the context of influenza A infection is other interesting case. The saltatory variant with cranial nerve involvement and lower limbs paresis has been demonstrated in one patient. Bands in cerebrospinal fluid are positive in three cases and anti-ganglioside antibodies in one patient. The syndrome of inappropriate secretion of antidiuretic hormone may explain some of the hyponatremias registered. The first line of treatment are inmunoglobulins in all patients. Plasmapheresis exchanges has been used as an additional therapy in four cases. These clusters of six axonal cases with atypical clinical features justifies the need for knowledge of these variants in order to achieve an early treatment. Late hyporeflexia and brachialfaciocervico, saltatory and lumbar forms should be considered in the spectrum of Guillain-Barre syndrome. The etiological study should rule out a lots of pathogens as influenza A.

  8. Post-operative outcomes after cleft palate repair in syndromic and non-syndromic children: a systematic review protocol.

    Science.gov (United States)

    Zhang, Zach; Stein, Michael; Mercer, Nigel; Malic, Claudia

    2017-03-09

    There is a lack of high-level evidence on the surgical management of cleft palate. An appreciation of the differences in the complication rates between different surgical techniques and timing of repair is essential in optimizing cleft palate management. A comprehensive electronic database search will be conducted on the complication rates associated with cleft palate repair using MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. Two independent reviewers with expertise in cleft pathology will screen all appropriate titles, abstracts, and full-text publications prior to deciding whether each meet the predetermined inclusion criteria. The study findings will be tabulated and summarized. The primary outcomes will be the rate of palatal fistula, the incidence and severity of velopharyngeal insufficiency, and the rate of maxillary hypoplasia with different techniques and also the timing of the repair. A meta-analysis will be conducted using a random effects model. The evidence behind the optimal surgical approach to cleft palate repair is minimal, with no gold standard technique identified to date for a certain type of cleft palate. It is essential to appreciate how the complication rates differ between each surgical technique and each time point of repair, in order to optimize the management of these patients. A more critical evaluation of the outcomes of different cleft palate repair methods may also provide insight into more effective surgical approaches for different types of cleft palates.

  9. Relationships among personality traits, metabolic syndrome, and metabolic syndrome scores: The Kakegawa cohort study.

    Science.gov (United States)

    Ohseto, Hisashi; Ishikuro, Mami; Kikuya, Masahiro; Obara, Taku; Igarashi, Yuko; Takahashi, Satomi; Kikuchi, Daisuke; Shigihara, Michiko; Yamanaka, Chizuru; Miyashita, Masako; Mizuno, Satoshi; Nagai, Masato; Matsubara, Hiroko; Sato, Yuki; Metoki, Hirohito; Tachibana, Hirofumi; Maeda-Yamamoto, Mari; Kuriyama, Shinichi

    2018-04-01

    Metabolic syndrome and the presence of metabolic syndrome components are risk factors for cardiovascular disease (CVD). However, the association between personality traits and metabolic syndrome remains controversial, and few studies have been conducted in East Asian populations. We measured personality traits using the Japanese version of the Eysenck Personality Questionnaire (Revised Short Form) and five metabolic syndrome components-elevated waist circumference, elevated triglycerides, reduced high-density lipoprotein cholesterol, elevated blood pressure, and elevated fasting glucose-in 1322 participants aged 51.1±12.7years old from Kakegawa city, Japan. Metabolic syndrome score (MS score) was defined as the number of metabolic syndrome components present, and metabolic syndrome as having the MS score of 3 or higher. We performed multiple logistic regression analyses to examine the relationship between personality traits and metabolic syndrome components and multiple regression analyses to examine the relationship between personality traits and MS scores adjusted for age, sex, education, income, smoking status, alcohol use, and family history of CVD and diabetes mellitus. We also examine the relationship between personality traits and metabolic syndrome presence by multiple logistic regression analyses. "Extraversion" scores were higher in those with metabolic syndrome components (elevated waist circumference: P=0.001; elevated triglycerides: P=0.01; elevated blood pressure: P=0.004; elevated fasting glucose: P=0.002). "Extraversion" was associated with the MS score (coefficient=0.12, P=0.0003). No personality trait was significantly associated with the presence of metabolic syndrome. Higher "extraversion" scores were related to higher MS scores, but no personality trait was significantly associated with the presence of metabolic syndrome. Copyright © 2018 Elsevier Inc. All rights reserved.

  10. Improving outpatient safety through effective electronic communication: a study protocol.

    Science.gov (United States)

    Hysong, Sylvia J; Sawhney, Mona K; Wilson, Lindsey; Sittig, Dean F; Esquivel, Adol; Watford, Monica; Davis, Traber; Espadas, Donna; Singh, Hardeep

    2009-09-25

    Health information technology and electronic medical records (EMRs) are potentially powerful systems-based interventions to facilitate diagnosis and treatment because they ensure the delivery of key new findings and other health related information to the practitioner. However, effective communication involves more than just information transfer; despite a state of the art EMR system, communication breakdowns can still occur. [1-3] In this project, we will adapt a model developed by the Systems Engineering Initiative for Patient Safety (SEIPS) to understand and improve the relationship between work systems and processes of care involved with electronic communication in EMRs. We plan to study three communication activities in the Veterans Health Administration's (VA) EMR: electronic communication of abnormal imaging and laboratory test results via automated notifications (i.e., alerts); electronic referral requests; and provider-to-pharmacy communication via computerized provider order entry (CPOE). Our specific aim is to propose a protocol to evaluate the systems and processes affecting outcomes of electronic communication in the computerized patient record system (related to diagnostic test results, electronic referral requests, and CPOE prescriptions) using a human factors engineering approach, and hence guide the development of interventions for work system redesign. This research will consist of multiple qualitative methods of task analysis to identify potential sources of error related to diagnostic test result alerts, electronic referral requests, and CPOE; this will be followed by a series of focus groups to identify barriers, facilitators, and suggestions for improving the electronic communication system. Transcripts from all task analyses and focus groups will be analyzed using methods adapted from grounded theory and content analysis.

  11. Studying privacy in electronic voting protocols and comparing its ...

    African Journals Online (AJOL)

    Then results of the investigations were given and the methods of providing privacy in the protocols were introduced. In the end these methods were examined and compared and the homomorphic encryption was proposed as the best method. Keywords: electronic voting; privacy; homomorphic encryption; blind signature ...

  12. Pathways to Language: A Naturalistic Study of Children with Williams Syndrome and Children with Down Syndrome

    Science.gov (United States)

    Levy, Yonata; Eilam, Ariela

    2013-01-01

    This is a naturalistic study of the development of language in Hebrew-speaking children with Williams syndrome (WS) and children with Down syndrome (DS), whose MLU extended from 1[multiplied by]0 to 4[multiplied by]4. Developmental curves over the entire span of data collection revealed minor differences between children with WS, children with DS,…

  13. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies.Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care

  14. Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial.

    Science.gov (United States)

    Wall, Peter Dh; Dickenson, Edward J; Robinson, David; Hughes, Ivor; Realpe, Alba; Hobson, Rachel; Griffin, Damian R; Foster, Nadine E

    2016-10-01

    Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility. In phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events. The final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12-26 weeks in 6-10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events. PHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839). ISRCTN 09754699. 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/

  15. PROTOCOL FOR THE EVALUATION AND FUNCTIONAL RE-EDUCATION OF THE LUMBARSACRAL PAIN SYNDROME WITH A MUSCULAR-LIGAMENT CAUSE

    Directory of Open Access Journals (Sweden)

    Călina Mirela-Lucia

    2009-03-01

    Full Text Available The current paper aims to evaluate the lumbar-sacral algo-functional syndromes with a muscular-ligament cause and to establish a staged program for its functional recovery which would also prevent reoccurrences and/ or complications, these being relatively frequent and with important functional implications [1]. These ailments,specific to patients who are at an active age have a particular social impact, important morbidity and can be easily mistaken for more serious lumbar-sacral ailments, thus leading to disproportionately serious, but inefficient for thereal cause, treatments [4].The study was made over a period of 6 months, on 18 patients with lumbar-sacral syndrome with a muscularligament cause, diagnosed as a result of clinical and paraclinic evaluation, an alternative etiology of the syndrome being excluded. The patients were integrated into a functional re-education programme which included drug therapy (anti-inflammatory +/- relaxant medication, physically-kinetically supported (thermal-kinetic-massage therapy, staged into 2 weeks, one and 3-6 months intervals, respectively. The results obtained emphasise the improvement in the clinical parameters form one stage to the other, in the third stage of the programme reaching asemi-complete (over 90% recovery of the affected areas, compared to the initial stages.

  16. Radiologic study of basal cell nevus syndrome

    International Nuclear Information System (INIS)

    Park, Tae Won

    1988-01-01

    Several cases of jaw cyst-basal cell nevus-bifid rib syndrome are presented. This syndrome consists principally of multiple jaw cysts, basal cell nevi, and bifid ribs but no one component is present in all patients. The purpose of this paper is to review the multiple characteristics of this syndrome and present three cases in a family and additional 4 cases. The many malformations associated with the syndrome have variable expressively. In the cases, multiple jaw cysts, pal mar and plantar pittings, bridging of sella, temporoparietal bossing, hypertelorism, cleft palate, and dystopia canthoru m have been observed.

  17. Secondary cancers among children with acute lymphoblastic leukaemia treated by the Tokyo Children's Cancer Study Group protocols: a retrospective cohort study.

    Science.gov (United States)

    Ishida, Yasushi; Maeda, Miho; Urayama, Kevin Y; Kiyotani, Chikako; Aoki, Yuki; Kato, Yoko; Goto, Shoko; Sakaguchi, Sachi; Sugita, Kenichi; Tokuyama, Mika; Nakadate, Naoya; Ishii, Eizaburo; Tsuchida, Masahiro; Ohara, Akira

    2014-01-01

    With improvement in survival, it is important to evaluate the impact of treatment on secondary cancers in acute lymphoblastic leukaemia (ALL) survivors. A retrospective cohort study comprising 2918 children diagnosed with ALL and enrolled on Tokyo Children's Cancer Study Group (TCCSG) protocols between 1984 and 2005 was conducted to evaluate the incidence of secondary cancers and associated factors including treatment protocol, cranial irradiation and other characteristics of the primary ALL. Thirty-seven patients developed secondary cancers, including acute myeloid leukaemia (n = 11), myelodysplastic syndrome (n = 5), non-Hodgkin lymphoma (n = 2), brain tumours (n = 13) and other solid carcinomas (n = 6) within a median follow-up duration of 9·5 years. The cumulative incidence of any secondary cancers was 1·0% (95% confidence interval (CI), 0·7-1·4%) at 10 years and 2·4% (95% CI, 1·5-3·7%) at 20 years, respectively. Standardized incidence rate ratio of secondary cancers was 9·3 (95% CI, 6·5-12·8). Multivariate analyses showed an increased risk of secondary cancers associated with the recent treatment protocol and cranial irradiation. There was no evidence of a reduction in secondary cancer incidence despite marked decreases in cranial irradiation use in the recent protocols. © 2013 John Wiley & Sons Ltd.

  18. Development of Acupuncture and Moxibustion Protocol in a Clinical Trial for Irritable Bowel Syndrome

    OpenAIRE

    Anastasi, Joyce K.; Capili, Bernadette; Chang, Michelle

    2017-01-01

    Traditional Chinese medicine encompasses many different practices, most notably acupuncture and moxibustion. Traditionally, these modalities are used in combination to augment treatment but seldom are they tested together in clinical studies. Numerous acupuncture studies have been conducted in Asia, Europe, and the United States but there have been few randomized controlled trials utilizing moxibustion outside of East Asia. Limited studies have described the use of a moxibustion control or pl...

  19. Alport syndrome in a Kazakh family: a case study

    Indian Academy of Sciences (India)

    Alport syndrome is a type-IV collagen inherited disorder caused by mutations in COL4A3 and COL4A4 (autosomal recessive) or COL4A5 (X-linked). In our study, we describe the case of Alport syndrome in a Kazakh family. The 20- year-old male, born in 1993, was diagnosed with chronic nephritic syndrome when he was ...

  20. Rett syndrome: a study of the face

    NARCIS (Netherlands)

    Allanson, Judith E.; Hennekam, Raoul C. M.; Moog, Ute; Smeets, Eric E.

    2011-01-01

    Rett syndrome is a unique disorder of neurodevelopment that is characterized by an evolving behavioral and developmental phenotype, which emerges after an apparently normal early infantile period. It almost exclusively affects females. The face of Rett syndrome is said to resemble that of Angelman

  1. Equal Improvement in Men and Women in the Treatment of Urologic Chronic Pelvic Pain Syndrome Using a Multi-modal Protocol with an Internal Myofascial Trigger Point Wand.

    Science.gov (United States)

    Anderson, Rodney U; Wise, David; Sawyer, Tim; Nathanson, Brian H; Nevin Smith, J

    2016-06-01

    Both men and women require treatment for urologic chronic pelvic pain syndromes (UCPPS), which includes interstitial cystitis/painful bladder syndrome, pelvic floor dysfunction, and chronic prostatitis/chronic pelvic pain syndrome. However, it is unknown if men and women respond differently to a protocol that includes specific physical therapy self-treatment using an internal trigger point wand and training in paradoxical relaxation. We performed a retrospective analysis by gender in a single arm, open label, single center clinical trial designed to evaluate the safety and effectiveness of a protocol for the treatment of UCPPS from October, 2008 to May, 2011. 314 adult men (79.9 %) and 79 (20.1 %) women met inclusion criteria. The median duration of symptoms was 60 months. The protocol required an initial 6-day clinic for training followed by a 6-month self-treatment period. The treatment included self-administered pelvic floor trigger point release with an internal trigger point device for physical therapy along with paradoxical relaxation training. Notable gender differences in prior treatments were observed. Men had a lower median [Interquartile Range] NIH-CPSI score at baseline than women (27 [21, 31] vs. 29 [22, 33], p = 0.04). Using a 1-10 scale with 10 = Most Severe, the median reduction in trigger point sensitivity was 3 units for both men and women after 6 months therapy (p = 0.74). A modified Intention to Treat analysis and a multivariate regression analysis found similar results. We conclude that men and women have similar, significant reductions in trigger point sensitivity with this protocol.

  2. The bakery protocol : a comparitive case-study in formal verification

    NARCIS (Netherlands)

    W.O.D. Griffioen; H.P. Korver

    1995-01-01

    textabstractA Comparative Case-Study in Formal Verification Groote and the second author verified (a version of) the Bakery Protocol in $muCRL$. Their process-algebraic verification is rather complex compared to the protocol. Now the question is: How do other verification techniques perform on this

  3. Replication protocol analysis: a method for the study of real-world design thinking

    DEFF Research Database (Denmark)

    Galle, Per; Kovacs, L. B.

    1996-01-01

    ’ is refined into a method called ‘replication protocol analysis’ (RPA), and discussed from a methodological perspective of design research. It is argued that for the study of real-world design thinking this method offers distinct advantages over traditional ‘design protocol analysis’, which seeks to capture...

  4. Temporomandibular disorders in burning mouth syndrome patients: an observational study.

    Science.gov (United States)

    Corsalini, Massimo; Di Venere, Daniela; Pettini, Francesco; Lauritano, Dorina; Petruzzi, Massimo

    2013-01-01

    Burning Mouth Syndrome (BMS) is a chronic disease characterized by absence of any lesions and burning of the oral mucosa associated to a sensation of dry mouth and/or taste alterations. The purpose of our study is to estimate signs and symptoms of Temporomandibular Disorders (TMD) in patients with BMS and to investigate for the existence of an association between BMS and TMD. Forty-four BMS patients were enrolled; BMS subtype was established according to the classification of Lamey. After a gnathological evaluation, according to the protocol of the European Academy of Craniomandibular Disorders, patients were classified by RDC/TMD criteria. The data were compared and analyzed using a chi-square test to describe the existence of an association between BMS and TMD. 65.9% the BMS patients showed disorders classified as primary signs and symptoms of TMD according to RDC / TMD criteria, and 72.7% showed parafunctional habits. The chi-square test revealed a statistically significant association (p = 0.035) between BMS and TMD. The data suggest that there is a possible relationship not yet well understood between BMS and TMD, may be for neurophatic alterations assumed for BMS that could be also engaged in TMD pathogenesis.

  5. Folk medicinal plant mixtures: Establishing a protocol for further studies.

    Science.gov (United States)

    Gras, Airy; Parada, Montse; Rigat, Montse; Vallès, Joan; Garnatje, Teresa

    2018-03-25

    Most ethnobotanical research bases its analyses on individual taxa catalogues and their uses, rather than on mixtures. However, mixtures constitute an important chapter of our different lines of research and they represent a large volume of information. The relevance of these data in folk medicine could be explained as a response to the cure of multicausal etiology diseases or by a possible polyvalent effect of the mixture as opposed to the effect of each taxon alone. The main goals are: i) to perform qualitative and quantitative analyses of these mixtures; ii) to carry out a comparison among the mixtures in two Catalan territories and their floristic composition; iii) to assess the worth of families association; and, iv) to evaluate whether the plants claimed to be used in mixtures have contraindications or possible negative interactions according to phytopharmaceutical literature. The ultimate goal is to test a protocol that can be implemented in similar studies. We have used data on medicinal plant mixtures obtained from two extensive ethnobotanical field studies carried out in two Catalan districts, Alt Empordà and Ripollès. The quantitative analyses by means of descriptive statistics were carried out with Excel. New contributions like the implementation of the Shannon index to quantify the diversity of families in plant combinations, the creation of a new index to calculate the taxon importance in mixtures, or the use of a social network analysis to study the connection between botanical families have been employed in this work. In total, a set of 484 mixtures from Alt Empordà and Ripollès (Catalonia, Iberian Peninsula) have been analysed: 462 for human use and 22 for veterinary. Thymus vulgaris and Rosmarinus officinalis are among the most commonly used species in mixtures. The aerial part of the plant is the most used, and the anticatarrhal usage is the most frequent in both territories. A wide diversity of families has been observed in mixtures and

  6. Study protocol for an approach based on diagnosis and therapy of cutaneous radiation induced lesions

    International Nuclear Information System (INIS)

    Di Giorgio, Marina; Vallerga, Maria B.; Radl, Analia; Portas, Mercedes

    2008-01-01

    Full text: In the frame of an agreement between the 'Hospital de Quemados del Gobierno de la Ciudad de Buenos Aires'-Burn Center- (a reference hospital of the Medical Radiological Emergency Response Network of Argentina) and the Nuclear Regulatory Authority, a research project for diagnostic and therapeutic approach of cutaneous radiation syndrome (CRS) is in progress. Sixty seven persons, which developed acute and/or late CRS, were included in this protocol from 1997 to 2007, treated with an equivalent therapeutic scheme and evaluated through clinical follow-up, serial photographic record and complementary tests (tele-thermography and high frequency ultrasonography). There exist individual variations that could condition the response to ionizing radiation (IR) in not only accidental but also planned exposures (such as radiotherapy and interventional radiology). Deficiencies in DNA repair mechanisms would be involved on hypersensitivity to deterministic effects of IR. Consequently, the characterization of DNA repair capacity in lymphocytes through cytokinesis blocked micronucleus (MN) and alkaline single-cell microgel electrophoresis (comet) assays could be suitable approaches to evaluate in vitro individual radiosensitivity. Under this context, individual radiosensitivity assessment was conducted in patients included in this research protocol that showed acute and/or late cutaneous reactions with grades 3 and 4 of the Toxicity Criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer. DNA repair capacity was evaluated through MN and comet assay for initial damage and after specific times of repair (0-120 minutes). DNA damage and repair capacity were quantified by the Olive tail moment. Previous own studies have identified three subpopulations, characterized by the mean values of their repair mean half-time: healthy controls (2.6 ± 0.3 minutes), average-reactor cancer patients (4.7 ± 2.9 minutes) and over

  7. Stressful life events and incident metabolic syndrome : The Hoorn study

    NARCIS (Netherlands)

    Rutters, F.; Pilz, S.; Koopman, A.D.; Rauh, S.P.; Pouwer, F.; Stehouwer, C.D.; Elders, P.J.; Nijpels, G.; Dekker, J.M.

    2015-01-01

    Stressful life events are associated with the metabolic syndrome in cross-sectional studies, but prospective studies addressing this issue are rare and limited. We therefore evaluated whether the number of stressful life events is associated with incident metabolic syndrome. We assessed the

  8. Síndromes mielodisplásicas: protocolo de exclusão Myelodysplastic syndrome: diagnostic protocol

    Directory of Open Access Journals (Sweden)

    Silvia Maria M. Magalhães

    2004-12-01

    heterogeneous clinical and laboratorial presentations, which result in progressive bone marrow failure and evolve to acute leukemia. Anemia is a common symptom. In elderly patients, it is not attributed to the normal aging process and the cause is identified in most cases. The presence of cytopenias associated with bone marrow dysplastic disorders may also be due to secondary and reversible non clonal disorders. Cytogenetic abnormalities found in a proportion of patients with myelodysplastic syndromes may be helpful in the differential diagnosis and to evaluate the prognosis. Ancillary laboratory tests to show clonality are not usually available. The diagnosis of myelodysplastic syndromes is, therefore, made by exclusion, sometimes helped by the passage of time. Considering the proposed multistep myelodysplastic syndrome pathogenesis, patients at the lowest grade, presenting minimal dysplastic features may be difficult to diagnose. Vitamin B12 and/or folate deficiency, recent exposure to heavy metals and recent cytotoxic or growth factor therapy should be considered absolute exclusion factors precluding the definite diagnosis. Alcohol use, chronic inflammatory states, auto-immune disorders, chronic liver or kidney diseases, hormonal disorders and viral infections including HIV must be ruled out or interpreted with caution. Some diseases of the pluripotential stem cells must also be distinguished from myelodysplastic syndromes. Exclusion of paroxysmal nocturnal hemoglobinuria and aplastic anemia may be difficult in the less common hypocellular myelodysplastic syndromes. Dysplastic abnormalities of the bone marrow, therefore, do not in themselves establish a diagnosis of myelodysplasia and a protocol of exclusion should be carried out.

  9. Pilot studies for the North American Soil Geochemical Landscapes Project - Site selection, sampling protocols, analytical methods, and quality control protocols

    Science.gov (United States)

    Smith, D.B.; Woodruff, L.G.; O'Leary, R. M.; Cannon, W.F.; Garrett, R.G.; Kilburn, J.E.; Goldhaber, M.B.

    2009-01-01

    In 2004, the US Geological Survey (USGS) and the Geological Survey of Canada sampled and chemically analyzed soils along two transects across Canada and the USA in preparation for a planned soil geochemical survey of North America. This effort was a pilot study to test and refine sampling protocols, analytical methods, quality control protocols, and field logistics for the continental survey. A total of 220 sample sites were selected at approximately 40-km intervals along the two transects. The ideal sampling protocol at each site called for a sample from a depth of 0-5 cm and a composite of each of the O, A, and C horizons. The HF. Separate methods were used for Hg, Se, total C, and carbonate-C on this same size fraction. Only Ag, In, and Te had a large percentage of concentrations below the detection limit. Quality control (QC) of the analyses was monitored at three levels: the laboratory performing the analysis, the USGS QC officer, and the principal investigator for the study. This level of review resulted in an average of one QC sample for every 20 field samples, which proved to be minimally adequate for such a large-scale survey. Additional QC samples should be added to monitor within-batch quality to the extent that no more than 10 samples are analyzed between a QC sample. Only Cr (77%), Y (82%), and Sb (80%) fell outside the acceptable limits of accuracy (% recovery between 85 and 115%) because of likely residence in mineral phases resistant to the acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset of 73 of these samples was analyzed for a suite of 19 organochlorine pesticides by gas chromatography. Only three of these samples had detectable pesticide concentrations. A separate sample of A-horizon soil was collected for microbial characterization by phospholipid fatty acid analysis (PLFA), soil enzyme assays, and determination of selected human and agricultural pathogens

  10. A Performance Study of LEACH and Direct Diffusion Routing Protocols in Wireless Sensor Network

    International Nuclear Information System (INIS)

    Fakher, S.; Sharshar, K.; Moawad, M.I.; Shokair, M.

    2016-01-01

    The Wireless Sensor Network (WSN) is composed of a large number of sensor nodes with limited computation communication, and battery facilities. One of the common applications of this network is environment monitoring through sensing motion, measuring temperature, humidity and radiation. One of the basic activities in WSN is data gathering which represents a great challenge. Many routing protocols are proposed for that network to collect and aggregate the data. The most popular ones are hierarchy and data centric routing protocols. The main goal of this study is to identify the most preferable routing protocol, to be used in each mobility model. This paper studies the performance of LEACH (Low Energy Adaptive Clustering Hierarchy) from hierarchy routing protocol and direct diffusion from data centric routing protocol which is not clarified until now. Moreover, a comparison between LEACH and direct diffusion protocol using NS2 simulator will be made, and an analysis of these protocols will be conducted. The comparison includes packet delivery ratio, throughput, average energy ratio, average delay, network lifetime, and routing overhead. The performance is evaluated by varying the number of sensor nodes under three mobility models Reference Point Group Mobility Model (RPGM), Manhattan and random waypoint mobility model. Simulation results show that LEACH routing protocol has a good performance in RPGM and Manhattan than random waypoint mobility model. Direct diffusion has a good performance in random waypoint mobility model than in RPGM and Manhattan mobility model

  11. Battered Child Syndrome; a Case Study

    Directory of Open Access Journals (Sweden)

    Arastoo Pezeshki

    2015-05-01

    Full Text Available One of the important and usual missed causes of pediatric traumas is child abuse. This ominous phenomenon, which can be presented physically, psychologically, sexually, and emotionally has grown significantly in recent years. Many children are not diagnosed in the early stages of evaluation. Battered Child Syndrome is used to describe the clinical condition of the child serious physical abuse by parents or caregivers. Medical staff should always keep the syndrome in their mind for those brought to the emergency department with trauma. In this report, we described a patient complained of dysphagia following a falling from a height and multiple epidural hematomas and final diagnosis of battered child syndrome.

  12. Ovarian hyperstimulation syndrome prevention strategies: oral contraceptive pills-dual gonadotropin-releasing hormone agonist suppression with step-down gonadotropin protocols.

    Science.gov (United States)

    Damario, Mark A

    2010-11-01

    The identification of patients at high risk for excessive responses to ovarian stimulation for in vitro fertilization and embryo transfer is essential in the tailoring of safe and effective treatment strategies. Known factors associated with increased sensitivity to gonadotropins include polycystic ovary syndrome, young age, prior ovarian hyperstimulation syndrome (OHSS), high baseline antral follicle count, and high baseline ovarian volume. Although several treatment strategies have been proposed for these patients, this report describes the experience using the dual suppression with gonadotropin step-down protocol. This protocol uses oral contraceptive pretreatment in combination with a long gonadotropin-releasing hormone agonist followed by a programmed step-down in gonadotropin dosing. Hormonal characteristics of dual suppression include an improved luteinizing hormone-to-follicle-stimulating hormone ratio and lower serum androgens, particularly dehydroepiandrosterone sulfate. Clinical characteristics of the protocol include a lower cancellation rate and favorable clinical and ongoing pregnancy rates per initiated cycle while mitigating the risk of OHSS. © Thieme Medical Publishers.

  13. The use of study registration and protocols in plastic surgery research: A systematic review.

    Science.gov (United States)

    Pidgeon, Thomas Edward; Limb, Christopher; Agha, Riaz A; Whitehurst, Katharine; Chandrakumar, Charmilie; Wellstead, Georgina; Fowler, Alexander J; Orgill, Dennis P

    2017-08-01

    In 2013, the Declaration of Helsinki changed to mandate that all research studies involving human subjects, rather than just clinical trials alone, must have a protocol registered in a publicly accessible database prior to the enrolment of the first patient. The objective of this work was to assess the number of research studies involving human participants published in leading journals of plastic surgery that had either published a protocol or registered a protocol with a publicly accessible database. This systematic review examined all research articles involving human participants published in Plastic and Reconstructive Surgery, The Journal of Plastic Reconstructive and Aesthetic Surgery and The Annals of Plastic Surgery from 1st April 2014-31st March 2015. The primary outcome measure was whether each study had either published or registered a protocol with any mainstream registry database. ClinicalTrials.gov, the International Standard Randomized Control Trial Number (ISRCTN) registry, the WHO (World Health Organisation) International Clinical Trials Registry Platform, The Cochrane Collaboration, the Research Registry, PROSPERO and PubMed were all reviewed. Of 595 included articles, the most common study designs were case series (n = 185, 31.1%). There were 24 randomized controlled trials (RCTs, 4.0%). A total of 24 studies had a protocol registered (4.0%). The most common database to register a protocol was with ClinicalTrials.gov (n = 17). The study design that most commonly had a registered protocol was the RCT (n = 8 of 24, 33.3% of RCTs). Three studies published a protocol in a journal (0.6%). Publication or registration of protocols for recent studies involving human participants in major plastic surgery journals is low. There is considerable scope to improve this and guidance is provided. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  14. The spectrum of Mobius syndrome: an electrophysiological study.

    NARCIS (Netherlands)

    Verzijl, H.T.F.M.; Padberg, G.W.A.M.; Zwarts, M.J.

    2005-01-01

    We studied the nature and extent of facial muscle innervation and the involvement of the motor and sensory long tracts in Mobius syndrome, in order to shed light on the pathophysiological mechanism of the syndrome. Standardized blink reflexes, direct responses of the facial nerves to the orbicularis

  15. Alport syndrome in a Kazakh family: a case study

    Indian Academy of Sciences (India)

    2National Research Center for Maternal and Child Health, 32 Turan Prospect, Astana 010000, Kazakhstan ... In our study, we describe the case of Alport syndrome in a Kazakh family. The 20-year-old male, born in 1993, was diagnosed with chronic nephritic syndrome, when he was 16 years old. ... Journal of Genetics, Vol.

  16. Intellectual development in Noonan syndrome: A longitudinal study

    NARCIS (Netherlands)

    Roelofs, R.L.; Janssen, N.; Wingbermühle, P.A.M.; Kessels, R.P.C.; Egger, J.I.M.

    2016-01-01

    INTRODUCTION: Although cognitive impairments in adults with Noonan syndrome seem to be limited to a low-average intelligence and slower processing speed, studies in children with Noonan syndrome have demonstrated more extensive cognitive problems. These include deficits in language skills, memory,

  17. A Comparative Study of Wireless Sensor Networks and Their Routing Protocols

    Directory of Open Access Journals (Sweden)

    Subhajit Pal

    2010-11-01

    Full Text Available Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs. Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols.

  18. A comparative study of wireless sensor networks and their routing protocols.

    Science.gov (United States)

    Bhattacharyya, Debnath; Kim, Tai-hoon; Pal, Subhajit

    2010-01-01

    Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs). Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols.

  19. [Neonatal Pearson syndrome. two case studies].

    Science.gov (United States)

    Collin-Ducasse, H; Maillotte, A-M; Monpoux, F; Boutté, P; Ferrero-Vacher, C; Paquis, V

    2010-01-01

    Among the etiologies of anemia in the newborn, those related to mitochondrial cytopathies are rare. Pearson syndrome is mostly diagnosed during infancy and characterized by refractory sideroblastic anemia with vacuolization of marrow progenitor cells and exocrine pancreatic dysfunction. We describe two diagnosed cases of Pearson syndrome in the early neonatal period caused by severe macrocytic aregenerative anemia. Bone marrow aspiration revealed sideroblastic anemia and vacuolization of erythroblastic precursors. The diagnosis was confirmed by genetic analysis revealing a deletion in the mitochondrial DNA. These two newborns received monthly transfusions. Five other newborns suffering from Pearson syndrome with various clinical symptoms were found in literature. Pearson syndrome, rarely diagnosed in newborns, should be suspected in the presence of macrocytic aregenerative anemia and requires a bone marrow aspirate followed by a genetic analysis from a blood sample. Copyright 2009 Elsevier Masson SAS. All rights reserved.

  20. MECONIUM ASPIRATION SYNDROME : A CLINICAL STUDY

    OpenAIRE

    BEHERA, MK; KULKARNI, SD; GUPTA, RK

    1998-01-01

    Forty two babies with Meconium aspiration syndrome managed in neonatal intensive care unit of a service hospital were analysed. Incidence was 1.7 per cent. Twelve babies were delivered by caserean section and 30 babies by vaginal route. Seventeen deliveries were conducted by team of gynaecologists, pediatrician and nursing staff whereas 25 deliveries were conducted by nursing staff alone. Out of total babies with meconium aspiration syndrome, thin meconium detected in 9 and thick meconium det...

  1. Nurse compliance with a protocol for safe injectable medication administration: comparison of two multicentre observational studies

    Science.gov (United States)

    Schutijser, Bernadette; Jongerden, Irene; Spreeuwenberg, Peter; Wagner, Cordula; de Bruijne, Martine

    2018-01-01

    Objectives Medication administration errors with injectable medication have a high risk of causing patient harm. To reduce this risk, all Dutch hospitals implemented a protocol for safe injectable medication administration. Nurse compliance with this protocol was evaluated as low as 19% in 2012. The aim of this second evaluation study was to determine whether nurse compliance had changed over a 4-year period, what factors were associated over time with protocol compliance and which strategies have been implemented by hospitals to increase protocol compliance. Methods In this prospective observational study, conducted between November 2015 and September 2016, nurses from 16 Dutch hospitals were directly observed during intravenous medication administration. Protocol compliance was complete if nine protocol proceedings were conducted correctly. Protocol compliance was compared with results from the first evaluation. Multilevel logistic regression analyses were used to assess the associations over time between explanatory variables and complete protocol compliance. Implemented strategies were classified according to the five components of the Systems Engineering Initiative for Patient Safety (SEIPS) model. Results A total of 372 intravenous medication administrations were observed. In comparison with 2012, more proceedings per administration were conducted (mean 7.6, 95% CI 7.5 to 7.7 vs mean 7.3, 95% CI 7.3 to 7.4). No significant change was seen in complete protocol compliance (22% in 2016); compliance with the proceedings ‘hand hygiene’ and ‘check by a second nurse’ remained low. In contrast to 2012, the majority of the variance was caused by differences between wards rather than between hospitals. Most implemented improvement strategies targeted the organisation component of the SEIPS model. Conclusions Compliance with ‘hand hygiene’ and ‘check by a second nurse’ needs to be further improved in order to increase complete protocol compliance. To do

  2. Evaluation of porcine reproductive and respiratory syndrome stabilization protocols in 23 French Farrow-to-finish farms located in a high-density swine area.

    Science.gov (United States)

    Berton, Pauline; Normand, Valérie; Martineau, Guy-Pierre; Bouchet, Franck; Lebret, Arnaud; Waret-Szkuta, Agnès

    2017-01-01

    Porcine reproductive and respiratory syndrome virus (PRRSV) is responsible for reproductive disorders in sows and respiratory problems in pigs, and has a major economic impact. Controlling PRRSV is therefore a priority for the swine industry. Stabilization of a herd, defined as the production of PRRSV-negative pigs at weaning from seropositive sows, is a common method of control, and different protocols have been described in the literature to achieve this stabilization. The objective of this study was to evaluate wether the combination of mass vaccination of sows and their piglets with a Genotype I modified live virus (MLV) vaccine, with temporal closure to the introduction of replacement animals and unidirectional pig and human flow can result in the production of PRRSV-negative pigs at weaning. The study took place in French farrow-to-finish farms located in a high-density swine area where the disease concerns over 60% of farms and only closely related strains of genotype I have been reported. Twenty-three 100-to-700 sow farrow-to-finish farms were selected prospectively between 2005 and 2014, regardless of their biosecurity level. Those farms adopted a stabilization protocol characterized by the following standardized measures: vaccination of sows, gilts, and piglets with the Genotype I MLV vaccine PORCILIS®PRRS, temporary herd closure, and strict internal biosecurity measures. Monitoring of herd status was then performed using a combination of 3 diagnostic tools: Real-time polymerase chain reaction (RT-PCR), enzyme-linked immunosorbent assay (ELISA), and Open reading frame (ORF) 5 and ORF7 sequencing. The status of finishing units (either active or inactive, meaning PRRSV-positive or PRRSV-negative, respectively) was not considered in this study. At the end of the monitoring period, considering the results of all the analyses, clinical signs, and epidemiology, 19 farms were considered stable and 1 remained unstable. In 3 farms it was commonly agreed to extend

  3. Study protocol for the Cities Changing Diabetes programme

    DEFF Research Database (Denmark)

    Napier, A David; Nolan, John J; Bagger, Malene

    2017-01-01

    . The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care......INTRODUCTION: Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many...... and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through...

  4. Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study.

    Science.gov (United States)

    Vischer, Nerina; Pfeiffer, Constanze; Kealy, Jennifer; Burri, Christian

    2017-01-01

    The trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa. We used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews. Protocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures. Our data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol

  5. [Turner syndrome: Study of 42 cases].

    Science.gov (United States)

    Bahíllo-Curieses, M Pilar; Prieto-Matos, Pablo; Quiroga González, Rocío; Regueras Santos, Laura; Blanco Barrio, Amaya; Rupérez Peña, Sara

    2016-10-21

    Turner syndrome (TS) is characterized by short stature, gonadal dysgenesis, and total or partial loss of X chromosome. A historical cohorts study of patients with TS≤18 years old followed up in public hospitals in Castilla y Leon was undertaken. Forty-two female patients were included (prenatal diagnosis 11.9%, neonatal diagnosis 14.3%) with current median age 11.9±4.2 years. Short stature was the reason for consultation in 87.1%. Total monosomy of X chromosome was present in 40.5%. The most frequently associated comorbidity was opthalmological (50%), with heart defects in 23.8%. Ninety-three percent were treated with growth hormone (GH), mean age at the beginning of treatment was 7.43±3.4 years and mean height standard deviation was -2.84±1.08. Final height was reached in 10 patients only (mean final height 151.47±6.09cm). Chronological age of puberty induction was 13.2±0.94 years (bone age 12.47±1.17 years). Short stature was an important clinical sign for the diagnosis of TS, accompanied in some cases by other findings, with good response to GH treatment. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  6. Candidate gene association studies in syndromic and non-syndromic cleft lip and palate

    Energy Technology Data Exchange (ETDEWEB)

    Daack-Hirsch, S.; Basart, A.; Frischmeyer, P. [Univ. of Iowa, IA (United States)] [and others

    1994-09-01

    Using ongoing case ascertainment through a birth defects registry, we have collected 219 nuclear families with non-syndromic cleft lip and/or palate and 111 families with a collection of syndromic forms. Syndromic cases include 24 with recognized forms and 72 with unrecognized syndromes. Candidate gene studies as well as genome-wide searches for evidence of microdeletions and isodisomy are currently being carried out. Candidate gene association studies, to date, have made use of PCR-based polymorphisms for TGFA, MSX1, CLPG13 (a CA repeat associated with a human homologue of a locus that results in craniofacial dysmorphogenesis in the mouse) and an STRP found in a Van der Woude syndrome microdeletion. Control tetranucleotide repeats, which insure that population-based differences are not responsible for any observed associations, are also tested. Studies of the syndromic cases have included the same list of candidate genes searching for evidence of microdeletions and a genome-wide search using tri- and tetranucleotide polymorphic markers to search for isodisomy or structural rearrangements. Significant associations have previously been identified for TGFA, and, in this report, identified for MSX1 and nonsyndromic cleft palate only (p = 0.04, uncorrected). Preliminary results of the genome-wide scan for isodisomy has returned no true positives and there has been no evidence for microdeletion cases.

  7. Research Protocol for Systematic Review and Meta-Analysis of Elder Abuse Prevalence Studies.

    Science.gov (United States)

    Yon, Yongjie; Mikton, Christopher; Gassoumis, Zachary D; Wilber, Kathleen H

    2017-06-01

    Elder abuse is an important public health and human rights issue, yet its true extent is not well understood. To address this, we will conduct a systematic review and meta-analysis of elder abuse prevalence studies from around the world. This protocol describes the methodological approach to be adopted for conducting this systematic review and meta-analysis. In particular, the protocol describes the search strategies and eligibility criteria to be used to identify and select studies and how data from the selected studies will be extracted for analysis. The protocol also describes the analytical approach that will be used to calculate pooled prevalence estimates and discusses the use of meta-regression to assess how studies' characteristics influence the prevalence estimates. This protocol conforms to the Preferred Reporting Items for Systematic reviews and Meta-Analysis - or PRISMA - guidelines and has been registered with the PROSPERO International Prospective Register of systematic reviews.

  8. Assessing the feasibility, acceptability, and potential effectiveness of a behavioral-automaticity focused lifestyle intervention for African Americans with metabolic syndrome: The Pick two to Stick to protocol.

    Science.gov (United States)

    Fritz, Heather; Brody, Aaron; Levy, Philip

    2017-09-01

    Metabolic syndrome (MetS) significantly increases the risk of developing diabetes and cardiovascular disease. Being physically active and eating a healthy diet can reduce MetS risk factors. Too frequently, however, studies report that the effects of interventions targeting those factors are not maintained once interventions are withdrawn. A potential solution to the problem is targeting behavioral automaticity (habit-development) to aid in initiation and maintenance of health-behavior changes. The Pick two to Stick To (P2S2), is an 8-week, theory-based hybrid (face-to-face/telecoaching) habit focused lifestyle intervention designed to increase healthful physical activity and dietary behavioral automaticity. The purpose of this article is to describe the rationale and protocol for evaluating the P2S2 program's feasibility, acceptability and potential effectiveness. Using a prospective, non-comparative design, the P2S2 program will be implemented by trained occupational therapy 'coaches' to 40 African Americans aged 40 and above with MetS recruited from the emergency department. Semi-structured interviews with participants, bi-weekly research meetings with study staff, and observations of intervention delivery will provide data for a process evaluation. Estimates of effectiveness include weight, blood pressure, waist circumference, BMI, and behavioral automaticity measures that will be collected at baseline and week 20. The P2S2 program could facilitate the development of healthful dietary and physical activity habits in an underserved population. Whether interventions aimed at changing habits can feasibly influence this automaticity, particularly for high-risk, low resource communities where other barriers exist, is not known. This pilot study, therefore, will fill an important gap, providing insight to inform subsequent trials.

  9. Uncommon genetic syndromes and narrative production - Case Studies with Williams, Smith-Magenis and Prader- Willi Syndromes

    OpenAIRE

    Garayzábal Heinze, Elena; Capo, Magdalena; Moruno Lopéz, Esther; Gonçalves, Óscar F.; Férnandez, Montserrat; Lens, María; Sampaio, Adriana

    2012-01-01

    This study compares narrative production among three syndromes with genetic microdeletions: Williams syndrome (WS), Smith-Magenis syndrome (SMS), and Prader-Willi syndrome (PWS), characterized by intellectual disabilities and relatively spared language abilities. Our objective is to study the quality of narrative production in the context of a common intellectual disability. To elicit a narrative production, the task Frog! Where Are You was used. Then, structure, process, an...

  10. A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

    Science.gov (United States)

    Hamilton, Michelle D; Cola, Philip A; Terchek, Joshua J; Werner, James J; Stange, Kurt C

    2011-01-01

    The "card study," in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks. Because an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study institutional review board (IRB) approval. We developed a protocol for a study of the card study method, allowing new card study proposals of specific research questions to be submitted as addenda to the approved Card Study Protocol. Seven card studies were proposed and approved under the Card Study Protocol during the first year after implementation, contrasted with one-card study proposed in the previous year. New card study ideas submitted as addenda to an approved protocol appeared to increase IRB comfort with the card study as a minimal risk method while reducing the hurdles to developing new study ideas. A Card Study Protocol allowing new study questions to be submitted as addenda decreases time between idea generation and IRB approval. Shortened turn-around times may be useful for translating ideas into action while reducing regulatory burden.

  11. Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol.

    Science.gov (United States)

    Röösli, Martin; Frei, Patrizia; Bolte, John; Neubauer, Georg; Cardis, Elisabeth; Feychting, Maria; Gajsek, Peter; Heinrich, Sabine; Joseph, Wout; Mann, Simon; Martens, Luc; Mohler, Evelyn; Parslow, Roger C; Poulsen, Aslak Harbo; Radon, Katja; Schüz, Joachim; Thuroczy, György; Viel, Jean-François; Vrijheid, Martine

    2010-05-20

    The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF) is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas.

  12. A longitudinal study of dental arch morphology in children with the syndrome of Crouzon or Apert

    NARCIS (Netherlands)

    Reitsma, J.H.; Elmi, P.; Ongkosuwito, E.M.; Buschang, P.H.; Prahl-Andersen, B.

    2013-01-01

    The aim of this study was to compare changes in dental arch morphology between patients with Crouzon syndrome or Apert syndrome and controls. Children between 4 and 14 yr of age with Crouzon syndrome (n = 40) or Apert syndrome (n = 28) were compared with non-syndromic controls (n = 457) in terms of

  13. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  14. Imaging studies for failed back surgery syndrome

    International Nuclear Information System (INIS)

    Cosnard, G.; Cordoliani, Y.S.; Sarrazin, J.L.; Soulie, D.

    1995-01-01

    In patients with failed back surgery syndrome, magnetic resonance imaging (MRI) can be the best first-line imaging study because it simplifies the diagnosis. This update is based on over 600 cases. MRI shows the scar tissue at the surgical site, persistent evidence of disk herniation for several weeks after surgery, and evidence of local and regional edema in one-fourth of cases. The edema is most marked between two months and two years after the operation and can misleadingly suggest discitis. MRI is the best investigation for detecting recurrent herniation at the same vertebral level or another level. Herniated disk material is seen as a mass that does not enhance after gadolinium, in contrast to the vascularized scar tissue. Free fragments are often clearly visible within the scar tissue. Fragments that migrate to the epidural space can give rise to granulomatous reactions. Scar tissue can be seen in the epidural space and within the disk; it can show enhancement after gadolinium for several years. The scar can be atrophic or hypertrophic and can encase or impinge on the dural sac and nerve roots. Pathological fibrosis cannot be differentiated from ordinary scar tissue. Arachnoiditis causing adherence of the nerve roots to the dura mater or to each other occurs in 5 % to 10 % of cases. Nerve root enhancement after gadolinium is seen in three-fourths of cases. Bone lesions are common, especially some time after surgery; they are usually accompanied with other lesions. Hematomas are seen in less than 10 % of cases. Infections are similarly rare (0.25 % each for discitis and epiduritis). The diagnosis of discitis is difficult and requires percutaneous biopsy of the disk, especially when MRI shows fluid within the disk, with decreased signal intensity on T2 images, and non enhancement after intravenous gadolinium. (authors). 19 refs., 7 figs

  15. Electrodiagnostic studies in Guillain-Barre syndrome

    NARCIS (Netherlands)

    J. Meulstee (Jan)

    1994-01-01

    textabstractThe Guillain-Barre syndrome (GBS) is a monophasic (sub)acute inflammatory demyelinating predominantly motor polyradiculo-neuropathy. Clinical criteria have been proposed by Asbury (Asbury et aI., 1978; Asbury and Cornblath, 1990). GBS is a selflimiting disease, however, up to 30% of the

  16. Growth study of cri du chat syndrome

    OpenAIRE

    Collins, M; Eaton-Evans, J

    2001-01-01

    We compared the growth of children with cri du chat (5p−) syndrome with the 1990 UK growth curves. Most subjects had impaired growth, particularly of head circumference. The more emaciated the child the more pronounced the microcephaly, showing the need for growth and nutrition monitoring.



  17. Growth study of cri du chat syndrome.

    Science.gov (United States)

    Collins, M S; Eaton-Evans, J

    2001-10-01

    We compared the growth of children with cri du chat (5p-) syndrome with the 1990 UK growth curves. Most subjects had impaired growth, particularly of head circumference. The more emaciated the child the more pronounced the microcephaly, showing the need for growth and nutrition monitoring.

  18. Paraneoplastic Neurological Syndromes: Clinical And Serological Studies

    NARCIS (Netherlands)

    S.G. Shamsili (Setareh)

    2011-01-01

    textabstractThe term “paraneoplastic syndromes” refers to symptoms or signs resulting from damage to organs or tissues that are remote from the site of a malignant neoplasm or its metastases. Paraneoplastic syndromes can affect most organs and tissues including the nervous system. Since the fi rst

  19. Math Learning Disability and Math LD Subtypes: Evidence from Studies of Turner Syndrome, Fragile X Syndrome, and Neurofibromatosis Type 1.

    Science.gov (United States)

    Mazzocco, Michele M. M.

    2001-01-01

    This study examined whether indicators of math learning disability were observed in 35 5- and 6-year-olds with either neurofibromatosis, Turner Syndrome, or fragile X syndrome and compared to controls. Findings indicate that girls with fragile X or Turner syndrome but not neurofibromatosis are significantly more likely to have specific math…

  20. TO STUDY THE INFLUENCE OF STRUCTURED EXERCISE PROTOCOL ON PHYSICAL ACTIVITY IN PERIMENOPAUSAL WOMEN

    Directory of Open Access Journals (Sweden)

    D. Manjusha

    2014-08-01

    Full Text Available Background: Peri-menopause is the stage immediately preceding menopause & lasts on average 4yrs. The hormonal changes in peri-menopausal women alter the cardiovascular status & increase the incidence of obesity. The purpose of this study is to improve physical activity of women to combat this risk in peri-menopausal women by using structured exercise protocol. Methods: A total of thirty peri-menopausal women who met inclusive criteria participated in this study with age between 35-45yrs. They were randomly divided into 2 groups-experimental group (group 1, n=15 and control group (group 2, n=15, a 12-week exercise protocol were given under supervision for experimental group. The experimental group underwent the protocol of warm up for 10min following 25min exercise protocol and 10min of cool down period. The same exercise protocols were followed by control group without supervision. Results: According to data analysis, a significant difference was found between pre and post values of BMI, WHR, Physical activity level and vo2 peak in both experimental and control groups(p<0.05, but comparatively more significant changes were found in experimental rather than control group(p<0.05. Conclusion: There was a significant change in physical factors like BMI, WHR and physical activity level and functional factors like vo2 peak. Hence, it is concluded that 12weeks exercise protocol is effective in peri-menopausal women.

  1. The Oxford Participation and Activities Questionnaire: study protocol.

    Science.gov (United States)

    Morley, David; Dummett, Sarah; Kelly, Laura; Dawson, Jill; Fitzpatrick, Ray; Jenkinson, Crispin

    2013-01-01

    With an ageing population and increasing demands on health and social care services, there is growing importance attached to the management of long-term conditions, including maximizing the cost-effectiveness of treatments. In line with this, there is increasing emphasis on the need to keep people both active and participating in daily life. Consequently, it is essential that well developed and validated instruments that can meaningfully assess levels of participation and activity are widely available. Current measures, however, are largely focused on disability and rehabilitation, and there is no measure of activity or participation for generic use that fully meets the standards set by regulatory bodies such as the US Food and Drug Administration. Here we detail a protocol for the development and validation of a new patient-reported outcome measure (PROM) for assessment of participation and activity in people experiencing a variety of health conditions, ie, the Oxford Participation and Activities Questionnaire (Ox-PAQ). The stages incorporated in its development are entirely in line with current regulations and represent best practice in the development of PROMs. Development of the Ox-PAQ is theoretically grounded in the World Health Organization International Classification of Functioning, Disability, and Health. The project incorporates a new strategy of engaging with stakeholders from the outset in an attempt to identify those characteristics of PROMs considered most important to a range of potential users. Items will be generated through interviews with patients from a range of conditions. Pretesting of the instrument will be via cognitive interviews and focus groups. A postal survey will be conducted, with data subject to factor and Rasch analysis in order to identify appropriate dimensions and redundant items. Reliability will be assessed by Cronbach's alpha and item-total correlations. A second, large-scale postal survey will follow, with the Ox-PAQ being

  2. The Oxford Participation and Activities Questionnaire: study protocol

    Directory of Open Access Journals (Sweden)

    Morley D

    2013-12-01

    Full Text Available David Morley, Sarah Dummett, Laura Kelly, Jill Dawson, Ray Fitzpatrick, Crispin JenkinsonNuffield Department of Population Health, University of Oxford, Oxford, UKBackground: With an ageing population and increasing demands on health and social care services, there is growing importance attached to the management of long-term conditions, including maximizing the cost-effectiveness of treatments. In line with this, there is increasing emphasis on the need to keep people both active and participating in daily life. Consequently, it is essential that well developed and validated instruments that can meaningfully assess levels of participation and activity are widely available. Current measures, however, are largely focused on disability and rehabilitation, and there is no measure of activity or participation for generic use that fully meets the standards set by regulatory bodies such as the US Food and Drug Administration. Here we detail a protocol for the development and validation of a new patient-reported outcome measure (PROM for assessment of participation and activity in people experiencing a variety of health conditions, ie, the Oxford Participation and Activities Questionnaire (Ox-PAQ. The stages incorporated in its development are entirely in line with current regulations and represent best practice in the development of PROMs.Methods: Development of the Ox-PAQ is theoretically grounded in the World Health Organization International Classification of Functioning, Disability, and Health. The project incorporates a new strategy of engaging with stakeholders from the outset in an attempt to identify those characteristics of PROMs considered most important to a range of potential users. Items will be generated through interviews with patients from a range of conditions. Pretesting of the instrument will be via cognitive interviews and focus groups. A postal survey will be conducted, with data subject to factor and Rasch analysis in order to

  3. Psychometric properties of health related quality of life measures in acute coronary syndrome patients: a systematic review protocol.

    Science.gov (United States)

    Brasil, Virginia; Oliveira, Gabriela; Moraes, Katarinne Lima

    2018-02-01

    The objective of this systematic review is to evaluate the psychometric properties and clinical utility of patient-reported outcome measures that assess health-related quality of life in patients with a clinical diagnosis of acute coronary syndrome.

  4. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial.

    Science.gov (United States)

    Kromer, Thilo O; de Bie, Rob A; Bastiaenen, Caroline H G

    2010-06-09

    Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants' adherence to the protocol, use of additional treatments

  5. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2010-06-01

    Full Text Available Abstract Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. Methods/Design This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants

  6. The Steven Johnson syndrome. A case study.

    Science.gov (United States)

    Baby, S; Doris, S

    1999-07-01

    Steven Johnson's Syndrome is a serious systemic disorder in which there are vesicobullous lesions involving the skin and mucous membranes. It can result as an immune response to an antigen or as a drug reaction. Most often it is considered as an allergic reaction. It is a self-limiting condition which responds to immediate management or may result in fluid loss, sepsis and death.

  7. SCISSOR-Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol.

    Science.gov (United States)

    Kopp, Marcel A; Liebscher, Thomas; Watzlawick, Ralf; Martus, Peter; Laufer, Stefan; Blex, Christian; Schindler, Ralf; Jungehulsing, Gerhard J; Knüppel, Sven; Kreutzträger, Martin; Ekkernkamp, Axel; Dirnagl, Ulrich; Strittmatter, Stephen M; Niedeggen, Andreas; Schwab, Jan M

    2016-07-26

    The approved analgesic and anti-inflammatory drugs ibuprofen and indometacin block the small GTPase RhoA, a key enzyme that impedes axonal sprouting after axonal damage. Inhibition of the Rho pathway in a central nervous system-effective manner requires higher dosages compared with orthodox cyclooxygenase-blocking effects. Preclinical studies on spinal cord injury (SCI) imply improved motor recovery after ibuprofen/indometacin-mediated Rho inhibition. This has been reassessed by a meta-analysis of the underlying experimental evidence, which indicates an overall effect size of 20.2% regarding motor outcome achieved after ibuprofen/indometacin treatment compared with vehicle controls. In addition, ibuprofen/indometacin may also limit sickness behaviour, non-neurogenic systemic inflammatory response syndrome (SIRS), neuropathic pain and heterotopic ossifications after SCI. Consequently, 'small molecule'-mediated Rho inhibition after acute SCI warrants clinical investigation. Protocol of an investigator-initiated clinical open-label pilot trial on high-dose ibuprofen treatment after acute traumatic, motor-complete SCI. A sample of n=12 patients will be enrolled in two cohorts treated with 2400 mg/day ibuprofen for 4 or 12 weeks, respectively. The primary safety end point is an occurrence of serious adverse events, primarily gastroduodenal bleedings. Secondary end points are pharmacokinetics, feasibility and preliminary effects on neurological recovery, neuropathic pain and heterotopic ossifications. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. Additional analyses will be mainly descriptive and casuistic. The clinical trial protocol was approved by the responsible German state Ethics Board, and the Federal Institute for Drugs and Medical Devices. The study complies with the Declaration of Helsinki, the principles of Good Clinical Practice and all further applicable regulations. This safety and pharmacokinetics trial

  8. SCISSOR—Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol

    Science.gov (United States)

    Kopp, Marcel A; Liebscher, Thomas; Watzlawick, Ralf; Martus, Peter; Laufer, Stefan; Blex, Christian; Schindler, Ralf; Jungehulsing, Gerhard J; Knüppel, Sven; Kreutzträger, Martin; Ekkernkamp, Axel; Dirnagl, Ulrich; Strittmatter, Stephen M; Niedeggen, Andreas; Schwab, Jan M

    2016-01-01

    Introduction The approved analgesic and anti-inflammatory drugs ibuprofen and indometacin block the small GTPase RhoA, a key enzyme that impedes axonal sprouting after axonal damage. Inhibition of the Rho pathway in a central nervous system-effective manner requires higher dosages compared with orthodox cyclooxygenase-blocking effects. Preclinical studies on spinal cord injury (SCI) imply improved motor recovery after ibuprofen/indometacin-mediated Rho inhibition. This has been reassessed by a meta-analysis of the underlying experimental evidence, which indicates an overall effect size of 20.2% regarding motor outcome achieved after ibuprofen/indometacin treatment compared with vehicle controls. In addition, ibuprofen/indometacin may also limit sickness behaviour, non-neurogenic systemic inflammatory response syndrome (SIRS), neuropathic pain and heterotopic ossifications after SCI. Consequently, ‘small molecule’-mediated Rho inhibition after acute SCI warrants clinical investigation. Methods and analysis Protocol of an investigator-initiated clinical open-label pilot trial on high-dose ibuprofen treatment after acute traumatic, motor-complete SCI. A sample of n=12 patients will be enrolled in two cohorts treated with 2400 mg/day ibuprofen for 4 or 12 weeks, respectively. The primary safety end point is an occurrence of serious adverse events, primarily gastroduodenal bleedings. Secondary end points are pharmacokinetics, feasibility and preliminary effects on neurological recovery, neuropathic pain and heterotopic ossifications. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. Additional analyses will be mainly descriptive and casuistic. Ethics and dissemination The clinical trial protocol was approved by the responsible German state Ethics Board, and the Federal Institute for Drugs and Medical Devices. The study complies with the Declaration of Helsinki, the principles of Good Clinical Practice and all further

  9. Design of a protocol for large-scale epidemiological studies in individual sports: the Swedish Athletics injury study.

    Science.gov (United States)

    Jacobsson, Jenny; Timpka, Toomas; Ekberg, Joakim; Kowalski, Jan; Nilsson, Sverker; Renström, Per

    2010-12-01

    Epidemiological studies have mainly been performed on team sports. The authors set out to develop a protocol for large-scale epidemiological studies of injuries among elite athletics athletes. An argument-based method for investigation of complex design problems was used to structure the collection and analysis of data. Specification of the protocol was preceded by an examination of requirements on injury surveillance in individual sports and iterated drafting of protocol specifications, and followed by formative evaluations. The requirements analysis shows that the central demand on the protocol is to allow for detailed epidemiological analyses of overuse injuries, which subsequently requires regular collection of self-reported data from athletes. The resulting study protocol is centred on a web-based weekly athlete e-diary enabling continual collection of individual-level data on exposure and injuries. To be able to interpret the self-reported data on injury events, collection of a wide range of personal baseline data from the athlete, including a psychological profile, is included in the protocol. The resulting protocol can be employed in intervention programmes that can prevent suffering among both adult elite and youth talent athletes who have made considerable life investments in their sport.

  10. "Aspergers syndrom är jag" En kvalitativ studie om hur det kan vara att leva med Aspergers syndrom

    OpenAIRE

    Abrahamsson, Charlotte; Behlic, Dzenana

    2005-01-01

    Asperger´s syndrome is a state with certain difficulties in social relations, communication and perception. People with Asperger´s syndrome often have a special interest for a certain topic. The main purpose of this study was to describe how grown people with Asperger´s syndrome make sense of living with Asperger´s syndrome. The inquiry was based on semi-structured interviews with eight persons with Asperger´s syndrome. We reached those subjects trough interest organisations for people with A...

  11. A Pilot Study on the effects of Music Therapy on Frontotemporal Dementia - developing a research protocol

    DEFF Research Database (Denmark)

    Ridder, Hanne Mette Ochsner; Wigram, Tony; Ottesen, Anne Marie

    2009-01-01

    . As an example of a non-pharmacologic treatment procedure music therapy was investigated. With the focus to develop a research protocol for a future larger population study a pilot study was carried out. In two case studies a combination of data collection methods were examined with the overall goal to document...... of Life (ADRQL), the Cohen-Mansfield Agitation Inventory (CMAI), and the Neuro-Psychiatric Inventory (NPI), and related to case descriptions and video analyses. Results: Recommendations for a mixed method research protocol focused on measuring the effect of music therapy with persons with frontotemporal......, and pharmacological treatment of the psychiatric symptoms is difficult, requiring specialist proficiency in the field. Pilot study: As there is not yet sufficient research that examines the effects of non-pharmacologic treatment with this group there is a need to develop valid and reliable research protocols...

  12. Burning mouth syndrome and associated factors: A case-control retrospective study.

    Science.gov (United States)

    Chimenos-Küstner, Eduardo; de Luca-Monasterios, Fiorella; Schemel-Suárez, Mayra; Rodríguez de Rivera-Campillo, María E; Pérez-Pérez, Alejandro M; López-López, José

    2017-02-23

    Burning mouth syndrome (BMS) can be defined as burning pain or dysesthesia on the tongue and/or other sites of the oral mucosa without a causative identifiable lesion. The discomfort is usually of daily recurrence, with a higher incidence among people aged 50 to 60 years, affecting mostly the female sex and diminishing their quality of life. The aim of this study was to evaluate the association between several pathogenic factors and burning mouth syndrome. 736 medical records of patients diagnosed of burning mouth syndrome and 132 medical records for the control group were studied retrospectively. The study time span was from January 1990 to December 2014. The protocol included: sex, age, type of oral discomfort and location, among other factors. Analysis of the association between pathogenic factors and BMS diagnosis revealed that only 3 factors showed a statistically significant association: triggers (P=.003), parafunctional habits (P=.006), and oral hygiene (P=.012). There were neither statistically significant differences in BMS incidence between sex groups (P=.408) nor association of BMS with the pathogenic factors of substance abuse (P=.915), systemic pathology (P=.685), and dietary habits (P=.904). Parafunctional habits like bruxism and abnormal movements of tongue and lips can explain the BMS main symptomatology. Psychological aspects and systemic factors should be always considered. As a multifactorial disorder, the treatment of BMS should be executed in a holistic way. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  13. Effectiveness of Aquatic Therapy vs Land-based Therapy for Balance and Pain in Women with Fibromyalgia: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Rivas Neira, Sabela; Pasqual Marques, Amélia; Pegito Pérez, Irene; Fernández Cervantes, Ramón; Vivas Costa, Jamile

    2017-01-19

    Fibromyalgia is a disease with an increasing incidence. It impairs the quality of life of patients and decreases their functional capacity. Aquatic therapy has already been used for managing the symptoms of this syndrome. However, aquatic therapy has only recently been introduced as a treatment modality for improving proprioception in fibromyalgia. The main objective of this study is to determine the effectiveness of two physiotherapy protocols, one in and one out of water, for improving balance and decreasing pain in women with fibromyalgia. The study protocol will be a single-blind randomised controlled trial. Forty women diagnosed with fibromyalgia will be randomly assigned into 2 groups: Aquatic Therapy (n = 20) or Land-based Therapy (n = 20). Both interventions include 60-min therapy sessions, structured into 4 sections: Warm-up, Proprioceptive Exercises, Stretching and Relaxation. These sessions will be carried out 3 times a week for 3 months. Primary outcomes are balance (static and dynamic) and pain (intensity and threshold). Secondary outcomes include functional balance, quality of life, quality of sleep, fatigue, self-confidence in balance and physical ability. Outcome measures will be evaluated at baseline, at the end of the 3-month intervention period, and 6-weeks post-treatment. Statistical analysis will be carried out using the SPSS 21.0 program for Windows and a significance level of p ≤ 0.05 will be used for all tests. This study protocol details two physiotherapy interventions in women with fibromyalgia to improve balance and decrease pain: aquatic therapy and land-based therapy. In current literature there is a lack of methodological rigour and a limited number of studies that describe physiotherapy protocols to manage fibromyalgia symptoms. High-quality scientific works are required to highlight physiotherapy as one of the most recommended treatment options for this syndrome. Date of publication in ClinicalTrials.gov: 18

  14. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol.

    Science.gov (United States)

    Hensel, Kendi L; Carnes, Michael S; Stoll, Scott T

    2016-11-01

    The structural and physiologic changes in a woman's body during pregnancy can predispose pregnant women to low back pain and its associated disability, as well as to complications of pregnancy, labor, and delivery. Anecdotal and empirical evidence has indicated that osteopathic manipulative treatment (OMT) may be efficacious in improving pain and functionality in women who are pregnant. Based on that premise, the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was designed as a prospective, randomized, placebo-controlled, and blinded clinical trial to evaluate the efficacy of an OMT protocol for pain during third-trimester pregnancy. The OMT protocol developed for the PROMOTE study was based on physiologic theory and the concept of the interrelationship of structure and function. The 12 well-defined, standardized OMT techniques used in the protocol are commonly taught at osteopathic medical schools in the United States. These techniques can be easily replicated as a 20-minute protocol applied in conjunction with usual prenatal care, thus making it feasible to implement into clinical practice. This article presents an overview of the study design and treatment protocols used in the PROMOTE study.

  15. Protocol: optimisation of a grafting protocol for oilseed rape (Brassica napus) for studying long-distance signalling.

    Science.gov (United States)

    Ostendorp, Anna; Pahlow, Steffen; Deke, Jennifer; Thieß, Melanie; Kehr, Julia

    2016-01-01

    Grafting is a well-established technique for studying long-distance transport and signalling processes in higher plants. While oilseed rape has been the subject of comprehensive analyses of xylem and phloem sap to identify macromolecules potentially involved in long-distance information transfer, there is currently no standardised grafting method for this species published. We developed a straightforward collar-free grafting protocol for Brassica napus plants with high reproducibility and success rates. Micrografting of seedlings was done on filter paper. Grafting success on different types of regeneration media was measured short-term after grafting and as the long-term survival rate (>14 days) of grafts after the transfer to hydroponic culture or soil. We compared different methods for grafting B. napus seedlings. Grafting on filter paper with removed cotyledons, a truncated hypocotyl and the addition of low levels of sucrose under long day conditions allowed the highest grafting success. A subsequent long-term hydroponic cultivation of merged grafts showed highest survival rates and best reproducibility.

  16. Viewing social scenes: a visual scan-path study comparing fragile X syndrome and Williams syndrome.

    Science.gov (United States)

    Williams, Tracey A; Porter, Melanie A; Langdon, Robyn

    2013-08-01

    Fragile X syndrome (FXS) and Williams syndrome (WS) are both genetic disorders which present with similar cognitive-behavioral problems, but distinct social phenotypes. Despite these social differences both syndromes display poor social relations which may result from abnormal social processing. This study aimed to manipulate the location of socially salient information within scenes to investigate the visual attentional mechanisms of: capture, disengagement, and/or general engagement. Findings revealed that individuals with FXS avoid social information presented centrally, at least initially. The WS findings, on the other hand, provided some evidence that difficulties with attentional disengagement, rather than attentional capture, may play a role in the WS social phenotype. These findings are discussed in relation to the distinct social phenotypes of these two disorders.

  17. The Evolution of Communication Protocols in an Online Web Discussion Site: A Case Study.

    Science.gov (United States)

    Bray, Marty

    This case study describes the use of World Wide Web discussion pages and examines the evaluation of online communication protocols in one graduate class. The study begins by describing the theories and grounding literature that guided the development of the online discussion site. The study also describes the process used to develop the online…

  18. The Strengthening Exercises in Shoulder Impingement trial (The SExSI-trial) investigating the effectiveness of a simple add-on shoulder strengthening exercise programme in patients with long-lasting subacromial impingement syndrome: Study protocol for a pragmatic, assessor blinded, parallel-group, randomised, controlled trial.

    Science.gov (United States)

    Clausen, Mikkel Bek; Bandholm, Thomas; Rathleff, Michael Skovdal; Christensen, Karl Bang; Zebis, Mette Kreutzfeldt; Graven-Nielsen, Thomas; Hölmich, Per; Thorborg, Kristian

    2018-03-02

    Subacromial impingement syndrome (SIS) is a painful, and often long lasting, shoulder condition affecting patient function and quality of life. In a recent study, we observed major strength impairments in shoulder external rotation and abduction (~30%) in a population of patients with pronounced and long-lasting SIS. However, the current rehabilitation of such strength impairments may be inadequate, with novel rehabilitation programmes including exercise therapy only improving external rotation strength by 4-13%. As these previous studies are the basis of current practice, this suggests that the strengthening component could be inadequate in the rehabilitation of these patients, and it seems likely that more emphasis should be placed on intensifying this part of the rehabilitation. The purpose of this study is to investigate the effectiveness of a programme consisting of progressive home-based resistance training using an elastic band, aimed at improving shoulder external rotation and abduction strength, added to usual care and initiated shortly after diagnosis has been established. A pragmatic randomised controlled superiority trial will be conducted, including 200 patients with pronounced and long-lasting SIS, diagnosed using predefined criteria. Participants will be randomised to receive either an add-on intervention of progressive home-based resistance training using an elastic band in addition to usual care or usual care alone in a 1:1 allocation ratio. The randomisation sequence is computer generated, with permuted blocks of random sizes. The primary outcome will be change in Shoulder Pain And Disability Index (SPADI) score from baseline to 16 weeks follow-up. Outcome assessors are blinded to group allocation. Intervention receivers will be kept blind to treatment allocation through minimal information about the content of the add-on intervention and control condition until group allocation is final. Analyses are performed by blinded data analysts. If

  19. Pregnancy outcome of “delayed start” GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study

    Directory of Open Access Journals (Sweden)

    Abbas Aflatoonian

    2017-08-01

    Full Text Available Background: Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART. Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards. Objective: The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF outcomes. Materials and Methods: This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30, delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30 treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups. Results: Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups. Conclusion: There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.

  20. Os trigonum syndrome: A retrospective and comparative study

    Directory of Open Access Journals (Sweden)

    Nihat Taşdemir

    2012-03-01

    Full Text Available Objectives: The aim of this study was to evaluate the os trigonum syndrome by magnetic resonance imaging (MRI.Materials and methods: A total of 76 ankle MRI images were evaluated, retrospectively. All MRI examinations were done in supine position with the injured foot in neutral position and then in forced plantar flexion.Results: Os trigonum syndrome was seen in 16/76 cases. Four of 16 os trigonum syndrome patients are female. The average age of this 16 patients who were defined as os trigonum syndrome by MRI was 34.81±14.16 years. Twelve of 16 os trigonum syndrome was seen in right ankle. Disruption of the cartilaginous synchondrosis between the accessory bone and the talus was observed in 12 patients. Tenosynovitis of the flexor halluces longus was associated in 7 patients. Subcutan edema, surrounding the os trigonum was detected in 11 patients.Conclusion: In patients with ostrigonum syndrome MR imaging allows complete diagnosis.

  1. Sarcopenia and its determinants among Iranian elderly (SARIR: study protocol

    Directory of Open Access Journals (Sweden)

    Hashemi Rezvan

    2012-11-01

    Full Text Available Abstract Background The elderly populations increase in world because of improved health status in communities, so health and independency of seniors has become and will be one of the main priorities of public health systems. Ageing have been associated with changes in body composition, including loss of muscle mass, loss of bone mass and increase fat mass. Involuntary age related loss of muscle mass, sarcopenia,has been linked to functional impairment and physical disability. Several definitions for sarcopenia have been presented based on the method of measuring body composition, but an internationally accepted definition doesn’t presently exist yet. In 2010, the European working group on sarcopenia developed a new definition for sarcopenia according to measure muscle mass and muscle function. Several studies have been done about sarcopenia in world, but to our knowledge this study is the first in Iran which is one of the largest countries of the Middle East that faces a fast growing elderly population. The aim of this study is to evaluate sarcopenia and related risk factors in Iran according new definition of sarcopenia. Methods This study will be conducted in two phase among elderly men and women over 55 years in the 6th district of TehranThe first phase will be a population-based cross-sectional study to determine the frequency of sarcopenia in the study population, and to conduct case finding for the second phase. The second phase will be a case–control study to comparison the metabolic and inflammatory factors in sarcopenic and non sarcopenic groups. The association between sarcopenia and major dietary pattern will be evaluated using factor analysis. Conclusion This study is the first study that evaluates sarcopenia and its risk factor in Iranian elderlies. We discuss details of how we collect the data and appropriate instruments to measure muscle mass, muscle power and muscle strength, and suitable cut- off to define sarcopenia in

  2. A clinical study of Noonan syndrome.

    Science.gov (United States)

    Sharland, M; Burch, M; McKenna, W M; Paton, M A

    1992-01-01

    Clinical details are presented on 151 individuals with Noonan syndrome (83 males and 68 females, mean age 12.6 years). Polyhydramnios complicated 33% of affected pregnancies. The commonest cardiac lesions were pulmonary stenosis (62%), and hypertrophic cardiomyopathy (20%), with a normal echocardiogram present in only 12.5% of all cases. Significant feeding difficulties during infancy were present in 76% of the group. Although the children were short (50% with a height less than 3rd centile), and underweight (43% with a weight less than 3rd centile), the mean head circumference of the group was on the 50th centile. Motor milestone delay was usual, the cohort having a mean age of sitting unsupported of 10 months and walking of 21 months. Abnormal vision (94%) and hearing (40%) were frequent findings, but 89% of the group were attending normal primary or secondary schools. Other associations included undescended testicles (77%), hepatosplenomegaly (50%), and evidence of abnormal bleeding (56%). The mean age at diagnosis of Noonan syndrome in this group was 9.0 years. Earlier diagnosis of this common condition would aid both clinical management and genetic counselling. Images Figure 1 Figure 2 Figure 3 PMID:1543375

  3. Impact of age on the selection of nuclear cardiology stress protocols: The INCAPS (IAEA nuclear cardiology protocols) study.

    Science.gov (United States)

    Al-Mallah, Mouaz H; Pascual, Thomas N B; Mercuri, Mathew; Vitola, João V; Karthikeyan, Ganesan; Better, Nathan; Dondi, Maurizio; Paez, Diana; Einstein, Andrew J

    2018-02-16

    There is growing concern about radiation exposure from nuclear myocardial perfusion imaging (MPI), particularly among younger patients who are more prone to develop untoward effects of ionizing radiation, and hence US and European professional society guidelines recommend age as a consideration in weighing radiation risk from MPI. We aimed to determine how patient radiation doses from MPI vary across age groups in a large contemporary international cohort. Data were collected as part of a global cross-sectional study of centers performing MPI coordinated by the International Atomic Energy Agency (IAEA). Sites provided information on each MPI study completed during a single week in March-April 2013. We compared across age groups laboratory adherence to pre-specified radiation-related best practices, radiation effective dose (ED; a whole-body measure reflecting the amount of radiation to each organ and its relative sensitivity to radiation's deleterious effects), and the proportion of patients with ED ≤ 9 mSv, a target level specified in guidelines. Among 7911 patients undergoing MPI in 308 laboratories in 65 countries, mean ED was 10.0 ± 4.5 mSv with slightly higher exposure among younger age groups (trend p value age groups, or in adherence to best practices based on the median age of patients in a laboratory. In contemporary nuclear cardiology practice, the age of the patient appears not to impact protocol selection and radiation dose, contrary to professional society guidelines. Copyright © 2017. Published by Elsevier B.V.

  4. A review of Down's syndrome studies and ionizing radiation

    International Nuclear Information System (INIS)

    Rose, K.S.B.

    1994-01-01

    This review collates results from 3 high dose (> 0.1 Gy) and 23 low dose epidemiological studies of parental radiation exposure and Down's syndrome incidence. A pattern of consistent results appears in 13 studies of irradiation received by women for diagnostic purposes. The pattern is an increase in Down's syndrome, the increase being approximately equivalent to an ovarian doubling dose of 20 mGy. The value is definitely not compatible with results from the high dose studies. Results from the other 10 low dose studies were used to test this value but most proved to be unsuitable for a variety of reasons. However, no associations between levels of high natural background and Down's syndrome have been observed in either New England or Aberdeen, which are areas in developed countries where reliable statistics ar collected. (author)

  5. Hemispherectomy in pediatric patients with epilepsy: a study of 45 cases with special emphasis on epileptic syndromes.

    Science.gov (United States)

    Caraballo, Roberto; Bartuluchi, Marcelo; Cersósimo, Ricardo; Soraru, Alejandra; Pomata, Hugo

    2011-12-01

    In this study we report the clinical outcomes of hemispherectomy for epilepsy in pediatric patients with special emphasis on the epileptic syndromes and their etiologies. We retrospectively studied 45 patients with medically refractory epilepsy with hemispheric lesions who underwent hemispherectomy at the "Hospital de Pediatría Prof. Dr. Juan P. Garrahan", Buenos Aires, Argentina between February 1990 and February 2010. Patients had been assessed using a standard protocol involving clinical, neuroradiological, neurophysiological, and neuropsychological teams. Twenty-seven males and 18 females with a mean age of 8.5 years (range, 2 months to 18 years) who underwent epilepsy surgery for refractory epilepsy were assessed. The mean time of follow-up was 9.5 years (range, 1 to 16 years). The following epileptic syndromes were recognized: West syndrome in 15 patients (33.5%), Rasmussen syndrome in 13 (29%), focal symptomatic epilepsy in 8 (17.5%), startle epilepsy in 6 (13.5%), Lennox-Gastaut syndrome in 2 (5%), and continuous spikes and waves during slow sleep in 1 (2%). The surgical specimens revealed malformations of cortical development in 18 patients (40%), Rasmussen encephalitis in 13 (29%), porencephalic lesions in 10 (22%), gliosis in 2 (4.4%), tumor in 1 (2.2%), and Sturge-Weber syndrome in 1 (2.2%). The outcome of hemispherectomy in pediatric patients is good for those with refractory epilepsies, such as West syndrome, Lennox-Gastaut syndrome, epileptic encephalopathy with continuous spikes and waves during slow sleep, and startle epilepsy arising from a hemispheric lesion associated with hemiplegia.

  6. Comparative study of chemotherapeutic protocols for advanced breast cancer

    International Nuclear Information System (INIS)

    Perveen, S.; Ilyas, N.; Shahid, M.A.; Asgar, S.

    2002-01-01

    Objective: To compare the efficacy and toxicity of epirubicin the two-dose levels with combination of standard chemotherapy drugs. Design: A single center trial conducted under the sponsorship of Pakistan oncology co-operative group (POCG). Place and Duration of Study: The trial was conducted at the Institute of Nuclear Medicine and Oncology Lahore (INMOL). The study started in October 1995 and patient accrual was completed in June 1997. Patients and Methods: Breast cancer patients presenting with distant metastases were randomized to receive either single agent epirubicin, 120 mg/ m/sup 2/ weekly (arm A), epirubicin 40 mg/m/sup 2/, (Arm B), standard CMF regimen (Arm C) or standard FEC regimen (Arm D). Efficacy of each regimen, its toxicity and the quality of life of the patients were the factors compared. Results: FEC showed a response rate of 68% with median duration of 14 months, CMF showed 57% response rate with median duration of 8 months. High dose epirubicin 120 mg/m/sup 2/ showed a response rate of 31% with response duration of 2.5 months, while epirubicin 40 mg/m/sup 2/ showed partial response (pr) in 17% of patients with response duration of 1.7 months. Both FEC and CMF arms were found to be more effective (p<0.05) than the epirubicin regimens. Conclusion: FEC regimen was most effective in producing long lasting palliation. Single agent regimens produced low response rare and intolerable toxicity amongst metastatic breast cancer patients. (author)

  7. Pacing, Conventional Physical Activity and Active Video Games to Increase Physical Activity for Adults with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Ferrar, Katia Elizabeth; Smith, Ashleigh E; Davison, Kade

    2017-08-01

    Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious illness of biological origin characterized by profound physical and cognitive exhaustion and postexertion malaise. Pacing is a common strategy used to manage available energy and complete activities of daily living; yet little research has investigated this as a strategy to increase physical activity levels. Typically, people living with ME/CFS are faced by unique barriers to physical activity participation and are less physically active than healthy peers. As such they are at increased risk of physical inactivity-related health consequences. Active video games may be a feasible and acceptable avenue to deliver physical activity intervention by overcoming many of the reported barriers to participation. The primary objective of this pilot study is to determine the feasibility and acceptability of active video games to increase physical activity levels of people with ME/CFS. The secondary aims are to explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing plus conventional physical activity to increase the physical activity levels of adults with ME/CFS and explore the relationship between physical activity and cumulative inflammatory load (allostatic load). This study will use a mixed method design, with a 3-arm pilot randomized controlled trial, exit interviews, and collection of feasibility and process data. A total of 30 adults with ME/CFS will be randomized to receive either (1) pacing, (2) pacing and conventional physical activity, or (3) pacing and active video gaming. The intervention duration will be 6 months, and participants will be followed up for 6 months postintervention completion. The intervention will be conducted in the participant's home, and activity intensity will be determined by continuously monitored heart rate and ratings of perceived exertion. Feasibility and acceptability and process data will be collected during and at the end

  8. Cancer incidence in kidney transplant recipients: a study protocol

    International Nuclear Information System (INIS)

    Pita-Fernandez, Salvador; Valdes-Cañedo, Francisco; Pertega-Diaz, Sonia; Seoane-Pillado, Maria Teresa; Seijo-Bestilleiro, Rocio

    2009-01-01

    Different publications show an increased incidence of neoplasms in renal transplant patients. The objective of this study is to determine the incidence of cancer in the recipients of renal transplants performed in the A Coruña Hospital (Spain) during the period 1981–2007. During the study period 1967 kidney transplants were performed, corresponding to 1710 patients. Patients with neoplasms prior to the transplant will be excluded (n = 38). A follow-up study was carried out in order to estimate cancer incidence after transplantation. For each patient, information included donor and recipient characteristics, patients and graft survival and cancer incidence after transplantation. Incident cancer is considered as new cases of cancer after the transplant with anatomopathological confirmation. Their location will be classified according to the ICD-9. The analysis will be calculated using the indirect standardisation method. Age-adjusted cancer incidence rates in the Spanish general population will be obtained from the Carlos III Health Institute, the National Epidemiology Centre of the Ministry of Science and Technology. Crude first, second and third-year post-transplantation cancer incidence rates will be calculated for male and female recipients. The number of cases of cancer at each site will be calculated from data in the clinical records. The expected number of cancers will be calculated from data supplied by the Carlos III Health Institute. For each tumour location we will estimate the standardized incidence ratios (SIRs), using sex-specific cancer incidence rates, by dividing the incidence rate for the transplant patients by the rate of the general population. The 95% confidence intervals of the SIRs and their associated p-values will be calculated by assuming that the observed cancers follow a Poisson distribution. Stratified analysis will be performed to examine the variation in the SIRs with sex and length of follow-up. Competing risk survival analysis

  9. Study protocol: effects of school gardens on children's physical activity.

    Science.gov (United States)

    Wells, Nancy M; Myers, Beth M; Henderson, Charles R

    2014-01-01

    Childhood obesity is an epidemic. Strategies are needed to promote children's healthy habits related to diet and physical activity. School gardens have the potential to bolster children's physical activity and reduce time spent in sedentary activity; however little research has examined the effect of gardens on children's physical activity. This randomized controlled trial (RCT) examines the effect of school gardens on children's overall physical activity and sedentary behavior; and on children's physical activity during the school day. In addition, physical activity levels and postures are compared using direct observation, outdoors, in the garden and indoors, in the classroom. Twelve New York State schools are randomly assigned to receive the school garden intervention or to serve in the wait-list control group that receives gardens and lessons at the end of the study. The intervention consists of a raised bed garden; access to a curriculum focused on nutrition, horticulture, and plant science and including activities and snack suggestions; resources for the school including information about food safety in the garden and related topics; a garden implementation guide provided guidance regarding planning, planting and maintaining the garden throughout the year; gardening during the summer; engaging volunteers; building community capacity, and sustaining the program. Data are collected at baseline and 3 post-intervention follow-up waves at 6, 12, and 18 months. Physical activity (PA) "usually" and "yesterday" is measured using surveys at each wave. In addition, at-school PA is measured using accelerometry for 3 days at each wave. Direct observation (PARAGON) is used to compare PA during an indoor classroom lesson versus outdoor, garden-based lesson. Results of this study will provide insight regarding the potential for school gardens to increase children's physical activity and decrease sedentary behaviors. Clinicaltrial.gov # NCT02148315.

  10. Syndromic surveillance in Vanuatu since Cyclone Pam: a descriptive study

    Directory of Open Access Journals (Sweden)

    George Worwor

    2016-12-01

    Full Text Available In 2012, Vanuatu designed and implemented a syndromic surveillance system based on the guidelines developed by the Pacific Community and the World Health Organization to provide early warning of outbreaks and other important public health events. Four core syndromes were endorsed for surveillance: acute fever and rash, prolonged fever, influenza-like illness and acute watery diarrhoea. In March 2015, Vanuatu was struck by Cyclone Pam, after which several important changes and improvements to the country's syndromic surveillance were made. To date, there has been no formal evaluation of whether regular reports are occurring or that core syndromes are being documented. We therefore carried out a descriptive study in the 11 sentinel sites in Vanuatu conducting syndromic surveillance between July and December 2015. There was a total of 53 822 consultations which were higher in the first 13 weeks (n = 29 622 compared with the last 13 weeks (n = 24 200. During the six months, there were no cases of acute fever and rash or prolonged fever. There were cases with influenza-like illness from week 27 to 35, but no case was reported after week 35. Acute watery diarrhoea occurred in one or two cases per week during the whole study period. For these two core syndromes, there were generally more females than males, and about one third were children aged under 5 years. In conclusion, Vanuatu implemented changes to its new syndromic surveillance system from July to December 2015, although laboratory components had not yet been incorporated. The laboratory components are working in 2016 and will be the subject of a further report.

  11. FIRE (facilitating implementation of research evidence: a study protocol

    Directory of Open Access Journals (Sweden)

    Seers Kate

    2012-03-01

    Full Text Available Abstract Background Research evidence underpins best practice, but is not always used in healthcare. The Promoting Action on Research Implementation in Health Services (PARIHS framework suggests that the nature of evidence, the context in which it is used, and whether those trying to use evidence are helped (or facilitated affect the use of evidence. Urinary incontinence has a major effect on quality of life of older people, has a high prevalence, and is a key priority within European health and social care policy. Improving continence care has the potential to improve the quality of life for older people and reduce the costs associated with providing incontinence aids. Objectives This study aims to advance understanding about the contribution facilitation can make to implementing research findings into practice via: extending current knowledge of facilitation as a process for translating research evidence into practice; evaluating the feasibility, effectiveness, and cost-effectiveness of two different models of facilitation in promoting the uptake of research evidence on continence management; assessing the impact of contextual factors on the processes and outcomes of implementation; and implementing a pro-active knowledge transfer and dissemination strategy to diffuse study findings to a wide policy and practice community. Setting and sample Four European countries, each with six long-term nursing care sites (total 24 sites for people aged 60 years and over with documented urinary incontinence Methods and design Pragmatic randomised controlled trial with three arms (standard dissemination and two different programmes of facilitation, with embedded process and economic evaluation. The primary outcome is compliance with the continence recommendations. Secondary outcomes include proportion of residents with incontinence, incidence of incontinence-related dermatitis, urinary tract infections, and quality of life. Outcomes are assessed at baseline

  12. Study protocol for the Fukushima health management survey

    International Nuclear Information System (INIS)

    Yasumura, Seiji; Hosoya, Mitsuaki; Yamashita, Shunichi; Kamiya, Kenji; Abe, Masafumi; Akashi, Makoto; Kodama, Kazunori; Ozasa, Kotaro

    2012-01-01

    The accidents that occurred at the Fukushima Daiichi Nuclear Power Plant after the Great East Japan Earthquake on 11 March 2011 have resulted in long-term, ongoing anxiety among the residents of Fukushima, Japan. Soon after the disaster, Fukushima Prefecture launched the Fukushima Health Management Survey to investigate long-term low-dose radiation exposure caused by the accident. Fukushima Medical University took the lead in planning and implementing this survey. The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects. This report describes the rationale and implementation of the Fukushima Health Management Survey. This cohort study enrolled all people living in Fukushima Prefecture after the earthquake and comprises a basic survey and 4 detailed surveys. The basic survey is to estimate levels of external radiation exposure among all 2.05 million residents. It should be noted that internal radiation levels were estimated by Fukushima Prefecture using whole-body counters. The detailed surveys comprise a thyroid ultrasound examination for all Fukushima children aged 18 years or younger, a comprehensive health check for all residents from the evacuation zones, an assessment of mental health and lifestyles of all residents from the evacuation zones, and recording of all pregnancies and births among all women in the prefecture who were pregnant on 11 March. All data have been entered into a database and will be used to support the residents and analyze the health effects of radiation. The low response rate (<30%) to the basic survey complicates the estimation of health effects. There have been no cases of malignancy to date among 38 114 children who received thyroid ultrasound examinations. The importance of mental health care was revealed by the mental health and lifestyle survey and the pregnancy and birth survey. This long

  13. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  14. Study protocol for the Fukushima Health Management Survey.

    Science.gov (United States)

    Yasumura, Seiji; Hosoya, Mitsuaki; Yamashita, Shunichi; Kamiya, Kenji; Abe, Masafumi; Akashi, Makoto; Kodama, Kazunori; Ozasa, Kotaro

    2012-01-01

    The accidents that occurred at the Fukushima Daiichi Nuclear Power Plant after the Great East Japan Earthquake on 11 March 2011 have resulted in long-term, ongoing anxiety among the residents of Fukushima, Japan. Soon after the disaster, Fukushima Prefecture launched the Fukushima Health Management Survey to investigate long-term low-dose radiation exposure caused by the accident. Fukushima Medical University took the lead in planning and implementing this survey. The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects. This report describes the rationale and implementation of the Fukushima Health Management Survey. This cohort study enrolled all people living in Fukushima Prefecture after the earthquake and comprises a basic survey and 4 detailed surveys. The basic survey is to estimate levels of external radiation exposure among all 2.05 million residents. It should be noted that internal radiation levels were estimated by Fukushima Prefecture using whole-body counters. The detailed surveys comprise a thyroid ultrasound examination for all Fukushima children aged 18 years or younger, a comprehensive health check for all residents from the evacuation zones, an assessment of mental health and lifestyles of all residents from the evacuation zones, and recording of all pregnancies and births among all women in the prefecture who were pregnant on 11 March. All data have been entered into a database and will be used to support the residents and analyze the health effects of radiation. The low response rate (<30%) to the basic survey complicates the estimation of health effects. There have been no cases of malignancy to date among 38 114 children who received thyroid ultrasound examinations. The importance of mental health care was revealed by the mental health and lifestyle survey and the pregnancy and birth survey. This long

  15. Study protocol: can a school gardening intervention improve children's diets?

    Science.gov (United States)

    Christian, Meaghan S; El Evans, Charlotte; Conner, Mark; Ransley, Joan K; Cade, Janet E

    2012-04-26

    The current academic literature suggests there is a potential for using gardening as a tool to improve children's fruit and vegetable intake. This study is two parallel randomised controlled trials (RCT) devised to evaluate the school gardening programme of the Royal Horticultural Society (RHS) Campaign for School Gardening, to determine if it has an effect on children's fruit and vegetable intake. Trial One will consist of 26 schools; these schools will be randomised into two groups, one to receive the intensive intervention as "Partner Schools" and the other to receive the less intensive intervention as "Associate Schools". Trial Two will consist of 32 schools; these schools will be randomised into either the less intensive intervention "Associate Schools" or a comparison group with delayed intervention. Baseline data collection will be collected using a 24-hour food diary (CADET) to collect data on dietary intake and a questionnaire exploring children's knowledge and attitudes towards fruit and vegetables. A process measures questionnaire will be used to assess each school's gardening activities. The results from these trials will provide information on the impact of the RHS Campaign for School Gardening on children's fruit and vegetable intake. The evaluation will provide valuable information for designing future research in primary school children's diets and school based interventions. ISRCTN11396528.

  16. Journey to vaccination: a protocol for a multinational qualitative study.

    Science.gov (United States)

    Wheelock, Ana; Miraldo, Marisa; Parand, Anam; Vincent, Charles; Sevdalis, Nick

    2014-01-31

    In the past two decades, childhood vaccination coverage has increased dramatically, averting an estimated 2-3 million deaths per year. Adult vaccination coverage, however, remains inconsistently recorded and substandard. Although structural barriers are known to limit coverage, social and psychological factors can also affect vaccine uptake. Previous qualitative studies have explored beliefs, attitudes and preferences associated with seasonal influenza (flu) vaccination uptake, yet little research has investigated how participants' context and experiences influence their vaccination decision-making process over time. This paper aims to provide a detailed account of a mixed methods approach designed to understand the wider constellation of social and psychological factors likely to influence adult vaccination decisions, as well as the context in which these decisions take place, in the USA, the UK, France, India, China and Brazil. We employ a combination of qualitative interviewing approaches to reach a comprehensive understanding of the factors influencing vaccination decisions, specifically seasonal flu and tetanus. To elicit these factors, we developed the journey to vaccination, a new qualitative approach anchored on the heuristics and biases tradition and the customer journey mapping approach. A purposive sampling strategy is used to select participants who represent a range of key sociodemographic characteristics. Thematic analysis will be used to analyse the data. Typical journeys to vaccination will be proposed. Vaccination uptake is significantly influenced by social and psychological factors, some of which are under-reported and poorly understood. This research will provide a deeper understanding of the barriers and drivers to adult vaccination. Our findings will be published in relevant peer-reviewed journals and presented at academic conferences. They will also be presented as practical recommendations at policy and industry meetings and healthcare

  17. Prenatal diagnosis of Down syndrome: A 13-year retrospective study.

    Science.gov (United States)

    Vičić, Ana; Hafner, Tomislav; Bekavac Vlatković, Ivanka; Korać, Petra; Habek, Dubravko; Stipoljev, Feodora

    2017-12-01

    The aim of this study is to summarize the experience on prenatal diagnosis of Down syndrome. The study includes a retrospective data analysis of 157 prenatally detected cases of Down syndrome, routinely diagnosed among 6448 prenatal investigations performed during a 13-year period (2002-2014) in a single tertiary center. The prevalence of diagnosed Down syndrome cases was 2.4%. Maternal age alone was indication for prenatal diagnosis in 47 cases (45.2%), increased first-/second-trimester biochemical screening test in 34 cases (21.7%), abnormal ultrasound examination in 69 cases (43.9%), positive familial history for chromosomal abnormalities in four cases, and high risk for trisomy 21 revealed by cell-free DNA testing in three cases. Ultrasound anomalies were present in total of 94 fetuses (59.8%). The most common abnormality was cystic hygroma found in 46 cases (29.3%). A regular form of Down syndrome (trisomy 21) was found in 147 cases (93.6%), Robertsonian translocation in six cases (3.8%), and mosaic form in four cases (2.6%). In prenatal diagnosis of Down syndrome noninvasive screening methods are important for estimation of individual risks, in both, young population of woman and older mothers, while conventional and molecular cytogenetic methods are essential for definite diagnosis and proper genetic counseling. Copyright © 2017. Published by Elsevier B.V.

  18. Sexuality in women with polycystic ovary syndrome: a pilot study

    Directory of Open Access Journals (Sweden)

    Jucilene Sales da Paixão Silva

    2010-12-01

    Full Text Available Objective: The objective of this study was to evaluate the sexual behavior of women with polycystic ovary syndrome and the relationship between sexual behavior and the clinical parameters related to this syndrome (obesity, hirsutism and menstrual irregularities. Methods: A cross-sectional study was carried out involving 48 women with polycystic ovary syndrome. The evaluation was based on the complaints reported by the women with particular emphasis on sexual satisfaction, the presence of a sexual partner, phases of the sexual response cycle (desire, arousal, orgasm and resolution phases, sexual frequency, practice of masturbation, evaluation of less usual sexual habits, degree of intimacy and the quality of communication in the women’s involvement with their sexual partner. The variables of sexual behavior (sexual satisfaction, masturbation, sexual fantasies, frequency of desire, arousal and orgasm were compared with three clinical parameters: menstrual cycle, hirsutism and body mass index (BMI. Results: The sexual initiation, ways of expressing sexuality, communication and intimacy with partner and sexual satisfaction were not influenced by the clinical aspects of the syndrome. With respect to association of polycystic ovary syndrome clinical parameters with sexual behavior, a statistically significant correlation was found with the menstrual cycle. Conclusion: The absence of menstruation affected sexual interest in activities not involving the partner, thus increasing the frequency of masturbation.

  19. Justice at Work and Metabolic Syndrome: the Whitehall II Study

    Science.gov (United States)

    Gimeno, David; Tabák, Ádám G.; Ferrie, Jane E.; Shipley, Martin J.; De Vogli, Roberto; Elovainio, Marko; Vahtera, Jussi; Marmot, Michael G.; Kivimäki, Mika

    2011-01-01

    Objectives Growing evidence shows that high levels of justice are beneficial for employee health, although biological mechanisms underlying this association are yet to be clarified. We aim to test whether high justice at work protects against metabolic syndrome. Methods A prospective cohort study of 20 civil service departments in London (the Whitehall II study) including 6123 male and female British civil servants aged 35 to 55 years without prevalent CHD at baseline (1985-1990). Perceived justice at work was determined by means of questionnaire on two occasions between 1985 and 1990. Follow-up for metabolic syndrome and its components occurring from 1990 through 2004 was based on clinical assessments on three occasions over more than 18 years. Results Cox proportional hazard models adjusted for age, ethnicity and employment grade showed that men who experienced a high level of justice at work had a lower risk of incident metabolic syndrome than employees with a low level of justice (hazard ratio 0.75; 95% confidence interval: 0.63-0.89). There was little evidence of an association between organizational justice and metabolic syndrome or its components in women (hazard ratio 0.88; 95%CI: 0.67-1.17). Conclusions Our prospective findings provide evidence of an association between high levels of justice at work and the development of metabolic syndrome in men. PMID:19819861

  20. Epileptic spasms in clusters and associated syndromes other than West syndrome: A study of 48 patients.

    Science.gov (United States)

    Caraballo, Roberto H; Fortini, Sebastian; Reyes, Gabriela; Carpio Ruiz, Aliria; Sanchez Fuentes, Salvador Vazquez; Ramos, Belen

    2016-07-01

    To study the different epilepsy syndromes that included epileptic spasms (ES) in clusters without hypsarrhythmia (WoH). Between 2/1990 and 7/2013, we registered 48 patients with the electroclinical diagnostic criteria of ES in clusters WoH. We recognized two subgroups. In the first subgroup of 30 patients, ES started at a mean age of 10.6 months (range, 2-40 months). Ictal EEG recordings showed diffuse high-amplitude slow waves in 15 patients, diffuse slow waves followed by voltage attenuation in six patients, diffuse fast rhythms in five, diffuse slow waves with superimposed fast rhythms in three, and diffuse sharp waves in one. In the second subgroup of 18 patients, nine had electroclinical features of Lennox-Gastaut syndrome, four had epilepsy with myoclonic and atonic seizures, two had Dravet syndrome, one 6-year-old boy had a non-convulsive status epilepticus characterized by atypical absences associated with ES, one had epilepsy with migrating seizures of infancy, and one patient had clinical features of subacute sclerosing panencephalitis with ES. ES started at a mean age of 6.3 years (range, 0.5-13 years). The ictal EEG recording during the ES showed diffuse fast rhythms in 10 cases, diffuse slow waves with superimposed fast rhythms in four, and diffuse slow waves in four. Our study shows two subgroups of children with ESWoH. The first subgroup had a well-defined electroclinical syndrome predominantly in infancy, and in the second subgroup ES was one more seizure type associated with an epileptic encephalopathy other than West syndrome predominantly occurring in childhood. Copyright © 2016 Elsevier B.V. All rights reserved.

  1. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

    Science.gov (United States)

    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  2. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  3. Asperger Syndrome and Schizophrenia: A Comparative Neuropsychological Study

    Science.gov (United States)

    Marinopoulou, Maria; Lugnegård, Tove; Unenge Hallerbäck, Maria; Gillberg, Christopher; Billstedt, Eva

    2016-01-01

    There has been an increasing interest in possible connections between autism spectrum disorder (ASD) and schizophrenia in the last decade. Neuropsychological comparison studies have, however, been few. The present study examined similarities and differences in intellectual and executive functioning between adults with Asperger syndrome (AS) and…

  4. Metacognitive Protocols: A Qualitative Study of Perceptions of "Smartness" of Adults and Children.

    Science.gov (United States)

    Morse, Linda W.; Smith-Mallette, Geraldine; Talento-Miller, Eileen

    Metacognition is a theoretical construct used to describe individuals' perceptions of their thinking processes and their own control over their thinking processes. This study examined the protocols of 78 undergraduates who responded to 3 questions from the Swanson Metacognitive Questionnaire: (1) What makes someone really smart? (2) How do…

  5. Digital protocol for reference-based guided surgery and immediate loading: a prospective clinical study

    NARCIS (Netherlands)

    Tahmaseb, A.; de Clerck, R.; Aartman, I.; Wismeijer, D.

    2012-01-01

    PURPOSE: To evaluate the performance of a computer-aided three-dimensional planning protocol in combination with previously inserted reference mini-implants and CAD/CAM technology to restore completely edentulous patients. The study evaluated implant and superstructure survival in a prospective

  6. Study protocol

    DEFF Research Database (Denmark)

    Thorsteinsson, Troels; Helms, Anne Sofie; Adamsen, Lis

    2013-01-01

    healthy classmates as ambassadors to facilitate the normalization of social life in the hospital. For children with cancer, RESPECT contributes to expanding knowledge on rehabilitation that can also facilitate rehabilitation of other children undergoing hospitalization for long-term illness....... intervention includes an educational program aimed at the child with cancer, the child’s schoolteachers and classmates, and the child’s parents. Children with cancer will each have two ambassadors assigned from their class. The ambassadors visit the child with cancer at the hospital at alternating 2-week...... intervals and participate in the intervention program. The physical and social intervention examines the effect of early, structured, individualized, and continuous physical activity from diagnosis throughout the treatment period. The patients are tested at diagnosis, at 3 and 6 months after diagnosis...

  7. Study protocol

    DEFF Research Database (Denmark)

    Smith, Benjamin E; Hendrick, Paul; Bateman, Marcus

    2017-01-01

    that target movements and activities patients find fearful and painful. High-quality research on exercise prescription in relation to pain mechanisms, not directed at specific tissue pathology, and dose response clearly warrants further investigation. Our primary aim is to establish the feasibility...... and acceptability of conducting a definitive RCT which will evaluate the clinical and cost-effectiveness of a loaded self-managed exercise programme for people with patellofemoral pain. METHOD: This is a single-centred, multiphase, sequential, mixed-methods trial that will evaluate the feasibility of running...... avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach...

  8. Study protocol

    DEFF Research Database (Denmark)

    Madsen, Helle Østergaard; Dam, Ole Henrik; Hageman, Ida

    2012-01-01

    and demographically matched control respondents will be contacted in a similar manner the subsequent winter season. The Seasonal Pattern Assessment Questionnaire rates seasonal variation within the six items: sleep, appetite, social activity, mood, energy and body weight. The Seasonal Pattern Assessment Questionnaire...... in persons with severe visual impairments or blindness and to compare the results to a control group without visual impairments. Moreover, the authors wish to investigate whether SAD is correlated to the degree of impairment or to the diagnosis. METHODS AND ANALYSIS: 2781 persons with visual impairments...... in a relevant scientific journal and be communicated to respondents and relevant institutions through cooperation with the Danish Association of the Blind....

  9. PROTOCOL FOR THE EVALUATION AND FUNCTIONAL RE-EDUCATION OF THE LUMBARSACRAL PAIN SYNDROME WITH A MUSCULAR-LIGAMENT CAUSE

    OpenAIRE

    Călina Mirela-Lucia; Rusu Ligia; Elena Taina Avramescu; Denisa Enescu-Bieru; Eugenia Rosulescu; Dragomir Mihai

    2009-01-01

    The current paper aims to evaluate the lumbar-sacral algo-functional syndromes with a muscular-ligament cause and to establish a staged program for its functional recovery which would also prevent reoccurrences and/ or complications, these being relatively frequent and with important functional implications [1]. These ailments,specific to patients who are at an active age have a particular social impact, important morbidity and can be easily mistaken for more serious lumbar-sacral ailments, t...

  10. Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

    Science.gov (United States)

    Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

    2014-12-01

    Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

  11. Dosimetry study on the conventional and three dimensional conformal radiation treatment planning protocols for rectal cancer

    International Nuclear Information System (INIS)

    Cai Yong; He Yuxiang; Han Shukui; Wu Hao; Gong Jian; Xu Bo

    2007-01-01

    Objective: To compare the dose distribution of clinical target volume (CTV), in normal tissues and organs for patients with rectal cancer on the conventional radiotherapy (2D) and three dimension- al conformal radiation treatment (3DCRT). Methods: The CT image data of 36 rectal cancer patients treated with 3DCRT were studied. The CTV, small bowel, colon, bladder, pelvic bone marrow, and femoral head and neck were contoured on consecutive axial slices of CT images. Two 3DCRT and three conventional treatment planning protocols were simulated using three dimensional treatment planning system (CMS Focus 2.31), were defined as 3D-3, 3D-4, 2D-2, 2D-3, 2D-4. The difference of five treatment planning protocols on the CTV and normal structure by analysis of dose-volume histograms (DVHs) were compared. Results: The D 95 and V 95 of these five protocols all exceeded 97%. The conformity index(CI) of 3D was obviously larger than that of 2D protocol. The dose inhomogeneity(DI) in 4 DCRT was less than that of 3 DCRT. The 3D as compared with the 2D, significantly reduced the mean dose of 45 Gy to the small bowel and colon. The 3D-3 as compared with the 2D-3, the 3D-4 as compared with the 2D-4, the mean dose of small bowel and colon was reduced by 28.5% and 25.7%, respectively. The 3D-3 as compared with the 2D-2, the 3D-3 as compared with the 2D-3 and the 3D4 as compared with the 2D-4, the percentage volume of small bowel and colon which received 45 Gy was reduced by 80.8% , 51.1% and 54.7% , respectively. Either the mean dose, or the percentage volume receiving 35 Gy and 45 Gy to the pelvic bone and bladder, the 3D planning protocols had advanage over the 2D planning protocols. The V 45 of bladder in 2D-2 planning proto- col was the highest in all planning protocols, exceeding 98%, but the highest V 45 of bladder was only 50% in the other planning protocols. Conclusions: Even though the difference in pelvic CTV of rectal cancer patients between the conventional radiotherapy and 3

  12. Exploratory Study of Childbearing Experiences of Women With Asperger Syndrome.

    Science.gov (United States)

    Gardner, Marcia; Suplee, Patricia D; Bloch, Joan; Lecks, Karen

    2016-01-01

    Increasing numbers of girls have been diagnosed with Asperger syndrome and other autism spectrum disorders (ASDs) over the past two decades; therefore, more women with ASDs are entering the childbearing phase of their lives. Little is known about the childbearing experiences of women with ASDs. This qualitative study describes the childbearing experiences of eight women with Asperger syndrome. Four major themes emerged: Processing Sensations, Needing to Have Control, Walking in the Dark, and Motherhood on My Own Terms. Clinicians can provide sensitive, individualized care by asking women with Asperger syndrome about their specific sensory experiences, counseling them about coping strategies for sensory intrusions, providing targeted support, and modifying the clinical environment to decrease distressing stimuli. © 2016 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses.

  13. [Intraoperative floppy iris syndrome--a prospective study].

    Science.gov (United States)

    Nicula, Cristina; Nicula, D; Popescu, Raluca

    2013-01-01

    is to evaluate the incidence and typical signs of floppy iris syndrome intraoperatory revealed in patients diagnosed with cataracts. We studied a total of 15 eyes diagnosed with cataracts, belonging to 14 patients who had been treated chronically with Tamsulosin for benign prostatic hyperplasia. In 80% of cases we have seen a preoperative semimidriasis which required iris hooks in 5 eyeballs. On 1 eye preoperative semimidriasis was sufficient for capsulorhexis, but later pupil became miotic, requiring iris hooks. On 4 eye flaccid iris was noticed, that prolabated in corneal incision. floppy iris syndrome occurs in patients treated with Tamsulosin for benign prostatic hyperplasia, generating a series of difficulties during cataract surgery.

  14. Clinical, radiological and imunogenectical study in patients with Reiter's Syndrome

    International Nuclear Information System (INIS)

    Souza Meirelles, E. de.

    1987-01-01

    This study puspose was to investigate the clinical, radiological and immunogenetical parameters from a brazilian Reiter's Syndrome population. Twenty Reiter's Syndrome patients from ''Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo'' were prospectivelly studied in their demographical (sex, race, age at study, age at disease onset and disease duration), epidemiological (family history), clinical (general, articular, mucocutaneous, genitourinary, ocular and intestinal manifestations besides functional capacity at study), radiological (sacro-iliitis, spondylitis and calcaneal spur) and immunogenetical (HLA loci A, B and DR typing). The technique employed in the 61 aloantigens from loci HLA A (17), B (34) and DR (10) typing was Terasaki microlymphocitotoxicity modified by Danilovs, had being performed in the ''Laboratorio de Imunogenetica da Faculdade de Medicina da Universidade de Sao Paulo''. We concluded that the clinical, radiological and immunogenetical Reiter's Syndrome expression in the brazilian population is similar to the others north american or european already studied populations and that the probability of one brazilian HLA B27 positie individual to develop Reiter's Syndrome is 19 fold larger when compared to one brazilian HLA B27 negative individual. (author) [pt

  15. Bioindicators in the MIDUS National Study: Protocol, Measures, Sample, and Comparative Context

    Science.gov (United States)

    Love, Gayle Dienberg; Seeman, Teresa E.; Weinstein, Maxine; Ryff, Carol D.

    2010-01-01

    Objectives MIDUS is a national study of health and aging among individuals aged 25 to 74 at baseline(1995/96). Longitudinal survey assessments (2004/05), were followed by biological assessments on a subsample aged 35–85. To facilitate public use, we describe the protocol, measures, and sample. Methods Respondents traveled to clinics for a two-day data collection protocol that included fasting blood specimens, 12-hour urine specimen, medical history, physical exam, bone densitometry, a laboratory challenge (heart rate variability, blood pressure, respiration, salivary cortisol). Results Response rates for the biological protocol (N = 1,255) were 39.3%, or 43.1% (adjusting for those who could not be located or contacted). Reasons for non-participation were travel, family obligations, and being too busy. Respondents were comparable to the recruitment pool on most demographic characteristics and health assessments. Discussion Strengths of the protocol vis-à-vis other similar studies include opportunities to link biological factors with diverse content from other MIDUS projects. PMID:20876364

  16. The Combined Intervention with Germinated Vigna radiata and Aerobic Interval Training Protocol Is an Effective Strategy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Other Alterations Related to the Metabolic Syndrome in Zucker Rats.

    Science.gov (United States)

    Kapravelou, Garyfallia; Martínez, Rosario; Nebot, Elena; López-Jurado, María; Aranda, Pilar; Arrebola, Francisco; Cantarero, Samuel; Galisteo, Milagros; Porres, Jesus M

    2017-07-19

    Metabolic syndrome (MetS) is a group of related metabolic alterations that increase the risk of developing non-alcoholic fatty liver disease (NAFLD). Several lifestyle interventions based on dietary treatment with functional ingredients and physical activity are being studied as alternative or reinforcement treatments to the pharmacological ones actually in use. In the present experiment, the combined treatment with mung bean ( Vigna radiata ), a widely used legume with promising nutritional and health benefits that was included in the experimental diet as raw or 4 day-germinated seed flour, and aerobic interval training protocol (65-85% VO₂ max) has been tested in lean and obese Zucker rats following a 2 × 2 × 2 (2 phenotypes, 2 dietary interventions, 2 lifestyles) factorial ANOVA (Analysis of Variance) statistical analysis. Germination of V. radiata over a period of four days originated a significant protein hydrolysis leading to the appearance of low molecular weight peptides. The combination of 4 day-germinated V. radiata and aerobic interval training was more efficient compared to raw V. radiata at improving the aerobic capacity and physical performance, hepatic histology and functionality, and plasma lipid parameters as well as reverting the insulin resistance characteristic of the obese Zucker rat model. In conclusion, the joint intervention with legume sprouts and aerobic interval training protocol is an efficient treatment to improve the alterations of glucose and lipid metabolism as well as hepatic histology and functionality related to the development of NAFLD and the MetS.

  17. The Combined Intervention with Germinated Vigna radiata and Aerobic Interval Training Protocol Is an Effective Strategy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD and Other Alterations Related to the Metabolic Syndrome in Zucker Rats

    Directory of Open Access Journals (Sweden)

    Garyfallia Kapravelou

    2017-07-01

    Full Text Available Metabolic syndrome (MetS is a group of related metabolic alterations that increase the risk of developing non-alcoholic fatty liver disease (NAFLD. Several lifestyle interventions based on dietary treatment with functional ingredients and physical activity are being studied as alternative or reinforcement treatments to the pharmacological ones actually in use. In the present experiment, the combined treatment with mung bean (Vigna radiata, a widely used legume with promising nutritional and health benefits that was included in the experimental diet as raw or 4 day-germinated seed flour, and aerobic interval training protocol (65–85% VO2 max has been tested in lean and obese Zucker rats following a 2 × 2 × 2 (2 phenotypes, 2 dietary interventions, 2 lifestyles factorial ANOVA (Analysis of Variance statistical analysis. Germination of V. radiata over a period of four days originated a significant protein hydrolysis leading to the appearance of low molecular weight peptides. The combination of 4 day-germinated V. radiata and aerobic interval training was more efficient compared to raw V. radiata at improving the aerobic capacity and physical performance, hepatic histology and functionality, and plasma lipid parameters as well as reverting the insulin resistance characteristic of the obese Zucker rat model. In conclusion, the joint intervention with legume sprouts and aerobic interval training protocol is an efficient treatment to improve the alterations of glucose and lipid metabolism as well as hepatic histology and functionality related to the development of NAFLD and the MetS.

  18. Factors influencing practice variation in the management of nephrotic syndrome: a qualitative study of pediatric nephrology care providers.

    Science.gov (United States)

    Samuel, Susan M; Flynn, Rachel; Zappitelli, Michael; Dart, Allison; Parekh, Rulan; Pinsk, Maury; Mammen, Cherry; Wade, Andrew; Scott, Shannon D

    2017-06-07

    Treatment protocols for childhood nephrotic syndrome are highly variable between providers and care centres. We conducted a qualitative study to understand the complex multilevel processes that lead to practice variation and influence provider management of nephrotic syndrome. Focus groups with multidisciplinary pediatric nephrology care providers ( n = 67) from 10 Canadian pediatric nephrology centres that had more than 1 pediatric nephrologist were conducted between September 2013 and April 2015. Focus group discussions were guided by the Ottawa Model for Research Use. We used a semistructured interview guide to elicit participants' perspectives regarding 1) the work setting and context of the clinical environment, 2) reasons for variation at the provider level and 3) clinical practice guidelines for nephrotic syndrome. Focus group discussions were transcribed and analyzed concurrently with the use of qualitative content analysis. Emerging themes were grouped into 2 categories: centre-level factors and provider-level factors. At the centre level, the type of care model used, clinic structures and resources, and lack of communication and collaboration within and between Canadian centres influenced care variation. At the provider level, use of experiential knowledge versus empirical knowledge and interpretation of patient characteristics influenced provider management of nephrotic syndrome. Centre- and provider-level factors play an important role in shaping practice differences in the management of childhood nephrotic syndrome. Further research is needed to determine whether variation in care is associated with disparities in outcomes. Copyright 2017, Joule Inc. or its licensors.

  19. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

    OpenAIRE

    Smith Chad E.; Lyons Brian; Hannon James C.

    2014-01-01

    Purpose. Complex training (CT) involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the...

  20. Consonants in Cri du Chat Syndrome: A Case Study

    Science.gov (United States)

    Kristoffersen, Kristian Emil

    2008-01-01

    This article reports on a longitudinal case study of consonant productions in one Norwegian girl with Cri du chat syndrome from age 4;6 to age 9;4. It was shown that she had many articulation errors throughout the period of observation. Furthermore, these errors were shown to fall into three main categories: (1) errors of differentiation and…

  1. Electrophysiological studies in the post-viral fatigue syndrome.

    OpenAIRE

    Jamal, G A; Hansen, S

    1985-01-01

    Single fibre electromyography (SFEMG) was studied in 40 patients with the post-viral fatigue syndrome. These patients were also assessed clinically, serologically, virologically and immunologically. About 75% of the patients had definitely abnormal SFEMG results. This was regarded as evidence of abnormality in the peripheral part of the motor unit. The muscle fibre was the likely site of involvement.

  2. Functional Communication Training in Rett Syndrome: A Preliminary Study

    Science.gov (United States)

    Byiers, Breanne J.; Dimian, Adele; Symons, Frank J.

    2014-01-01

    Rett syndrome (RTT) is associated with a range of serious neurodevelopmental consequences including severe communicative impairments. Currently, no evidence-based communication interventions exist for the population (Sigafoos et al., 2009). The purpose of the current study was to examine the effectiveness of functional assessment (FA) and…

  3. Marfan syndrome in Europe - A questionnaire study on patient perceptions

    NARCIS (Netherlands)

    de Bie, Sylvia; de Paepe, Anne; Delvaux, Isabelle; Davies, Sally; Hennekam, Raoul C. M.

    2004-01-01

    OBJECTIVES: Marfan syndrome (MFS) is a relatively frequent systemic connective tissue disorder with an important physical morbidity and mortality. The influences of MFS on physical problems, perception of severity, and impact on the quality of life and psychosocial well-being have been studied only

  4. Recumbence syndrome around calving in cattle: A Study of Risk ...

    African Journals Online (AJOL)

    A recumbency syndrome around calving in cattle was reported in Dar es salaam during the dry season and was thought to be associated with milk fever a disease common in high producing mature dairy cattle and is related to age, dry cow nutrition and general management. This study was conducted to establish the length ...

  5. A novel protocol for dispatcher assisted CPR improves CPR quality and motivation among rescuers-A randomized controlled simulation study.

    Science.gov (United States)

    Rasmussen, Stinne Eika; Nebsbjerg, Mette Amalie; Krogh, Lise Qvirin; Bjørnshave, Katrine; Krogh, Kristian; Povlsen, Jonas Agerlund; Riddervold, Ingunn Skogstad; Grøfte, Thorbjørn; Kirkegaard, Hans; Løfgren, Bo

    2017-01-01

    Emergency dispatchers use protocols to instruct bystanders in cardiopulmonary resuscitation (CPR). Studies changing one element in the dispatcher's protocol report improved CPR quality. Whether several changes interact is unknown and the effect of combining multiple changes previously reported to improve CPR quality into one protocol remains to be investigated. We hypothesize that a novel dispatch protocol, combining multiple beneficial elements improves CPR quality compared with a standard protocol. A novel dispatch protocol was designed including wording on chest compressions, using a metronome, regular encouragements and a 10-s rest each minute. In a simulated cardiac arrest scenario, laypersons were randomized to perform single-rescuer CPR guided with the novel or the standard protocol. a composite endpoint of time to first compression, hand position, compression depth and rate and hands-off time (maximum score: 22 points). Afterwards participants answered a questionnaire evaluating the dispatcher assistance. The novel protocol (n=61) improved CPR quality score compared with the standard protocol (n=64) (mean (SD): 18.6 (1.4)) points vs. 17.5 (1.7) points, pCPR. A novel bundle of care protocol improved CPR quality score and motivation among rescuers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  6. Stream Control Transmission Protocol as a Transport for SIP: a case study

    Directory of Open Access Journals (Sweden)

    Giuseppe De Marco

    2004-06-01

    Full Text Available The dominant signalling protocol both in future wireless and wired networks will be the Session Initiation Protocol (SIP, as pointed out in the 3G IP-based mobile networks specifications, entailing a fully Internet integrated network. The use of SIP in the IP Multimedia Subsytem (IMS of Release 5 involves the development of servers capable to handle a large number of call requests. The signaling traffic associated to such requests could explode, if an intelligent congestion control were not introduced. Stream Control Transmission Protocol (SCTP was born to support transport of SS7 signaling messages. However, many of the SCTP features are also useful for transport of SIP messages, as: congestion control mechanism, good separation among independent messages, multihoming. Indeed, adoption of SCTP as transport of SIP signaling might prove useful in some situations where usual transport protocols, like TCP and UDP, suffer performance degradation. In this paper, we analyse the general framework wherein SIP operates and we discuss the benefits of using SCTP as a transport for SIP, toward fair sharing of network resources. This study is carried on in the context of the implementation of an high-performance SIP Proxy Server. We also present some preliminar results of an implementation of SIP over SCTP/UDP in a real LAN environment.

  7. Disinfection Contact Time study plan (100-N Area tracer protocol). Revision 1

    International Nuclear Information System (INIS)

    Kretzschmar, S.P.; Bedi, G.S.; Martinez, P.; Ervin, K.

    1996-07-01

    Bechtel Hanford, Inc. will prepare an Engineering Tracer Study Protocol for the determination of contact time for the disinfection process at Group A Non-transient Non-community water treatment plant for the 100-N Water Plant at the Hanford Site in Richland, Washington. Included in this report are the results of a study that determine the actual detention time within the plant clearwell, and thus the disinfection contact time at several clearwell effluent flow rates

  8. Plain packaging of cigarettes and smoking behavior: study protocol for a randomized controlled study.

    Science.gov (United States)

    Maynard, Olivia M; Leonards, Ute; Attwood, Angela S; Bauld, Linda; Hogarth, Lee; Munafò, Marcus R

    2014-06-25

    Previous research on the effects of plain packaging has largely relied on self-report measures. Here we describe the protocol of a randomized controlled trial investigating the effect of the plain packaging of cigarettes on smoking behavior in a real-world setting. In a parallel group randomization design, 128 daily cigarette smokers (50% male, 50% female) will attend an initial screening session and be assigned plain or branded packs of cigarettes to smoke for a full day. Plain packs will be those currently used in Australia where plain packaging has been introduced, while branded packs will be those currently used in the United Kingdom. Our primary study outcomes will be smoking behavior (self-reported number of cigarettes smoked and volume of smoke inhaled per cigarette as measured using a smoking topography device). Secondary outcomes measured pre- and post-intervention will be smoking urges, motivation to quit smoking, and perceived taste of the cigarettes. Secondary outcomes measured post-intervention only will be experience of smoking from the cigarette pack, overall experience of smoking, attributes of the cigarette pack, perceptions of the on-packet health warnings, behavior changes, views on plain packaging, and the rewarding value of smoking. Sex differences will be explored for all analyses. This study is novel in its approach to assessing the impact of plain packaging on actual smoking behavior. This research will help inform policymakers about the effectiveness of plain packaging as a tobacco control measure. Current Controlled Trials ISRCTN52982308 (registered 27 June 2013).

  9. A simulation study comparing aberration detection algorithms for syndromic surveillance

    Directory of Open Access Journals (Sweden)

    Painter Ian

    2007-03-01

    Full Text Available Abstract Background The usefulness of syndromic surveillance for early outbreak detection depends in part on effective statistical aberration detection. However, few published studies have compared different detection algorithms on identical data. In the largest simulation study conducted to date, we compared the performance of six aberration detection algorithms on simulated outbreaks superimposed on authentic syndromic surveillance data. Methods We compared three control-chart-based statistics, two exponential weighted moving averages, and a generalized linear model. We simulated 310 unique outbreak signals, and added these to actual daily counts of four syndromes monitored by Public Health – Seattle and King County's syndromic surveillance system. We compared the sensitivity of the six algorithms at detecting these simulated outbreaks at a fixed alert rate of 0.01. Results Stratified by baseline or by outbreak distribution, duration, or size, the generalized linear model was more sensitive than the other algorithms and detected 54% (95% CI = 52%–56% of the simulated epidemics when run at an alert rate of 0.01. However, all of the algorithms had poor sensitivity, particularly for outbreaks that did not begin with a surge of cases. Conclusion When tested on county-level data aggregated across age groups, these algorithms often did not perform well in detecting signals other than large, rapid increases in case counts relative to baseline levels.

  10. Lennox–Gastaut syndrome: A prospective follow-up study

    Directory of Open Access Journals (Sweden)

    Bhanu Pratap Rathaur

    2017-01-01

    Full Text Available Objectives: Lennox–Gastaut syndrome is a catastrophic epileptic encephalopathy. In Lennox–Gastaut syndrome, seizures are resistant to pharmacological treatment. In this prospective study, we evaluated the clinical features, neuroimaging, and response to treatment. Materials and Methods: Forty-three consecutive newly diagnosed patients of Lennox–Gastaut syndrome were enrolled in the study. Baseline clinical assessment included seizure semiology, seizure frequency, electroencephalography, and neuroimaging. Patients were treated with combinations of preferred antiepileptic drugs (sodium valproate [VPA], clobazam [CLB], levetiracetam [LVT], lamotrigine [LMT], and topiramate [TPM]. Patients were followed for 6 months. The outcome was assessed using modified Barthel index. Results: Tonic and generalized tonic-clonic forms were the most common seizures types. Features suggestive of hypoxic-ischemic encephalopathy (37.2% were most frequent neuroimaging abnormality. Neuroimaging was normal in 32.6% of patients. With a combination valproic acid (VPA, CLB, and LVT, in 81.4% of patients, we were able to achieve >50% reduction in seizure frequency. Eleven (25.58% patients showed an improvement in the baseline disability status. Conclusions: A combination of VPA, CLB, and LVT is an appropriate treatment regimen for patients with Lennox–Gastaut syndrome.

  11. Photoanthropometric Study of Dysmorphic Features of the Face in Children with Autism and Asperger Syndrome

    Directory of Open Access Journals (Sweden)

    Katarzyna Ziora

    2012-04-01

    Full Text Available Objective: Childhood autism is a neurodevelopmental disorder characterized by impairments in social interactions, verbal and non-verbal communication and by a pattern of stereotypical behaviors and interests. The aim of this study was to estimate the dysmorphic facial features of children with autism and children with Asperger syndrome . Methods: The examination was conducted on 60 children (30 with childhood autism and 30 with Asperger syndrome. The photo anthropometric method used in this study followed the protocol established by Stengel-Rutkowski et al . Results: The performed statistical analysis showed that in patients with childhood autism, the anteriorly rotated ears and the long back of the nose appeared more often. In the group of children with autism, there was a connection between the amount of dysmorphies and the presence of some somatic diseases in the first-degree relatives. There was also a connection between the motor coordination and the age the child began to walk. Discussion: In patients with childhood autism, there were certain dysmorphies (like the anterior rotated ears and the long back of the nose which appeared more often. Although the connection was not statistically significant, it seemed to concur with data from the literature . Conclusion: Formulation of the other conclusions would require broader studies e.g. dealing with a familial analysis of dysmorphic features.

  12. Photoanthropometric study of dysmorphic features of the face in children with autism and asperger syndrome.

    Science.gov (United States)

    Gorczyca, Piotr; Kapinos-Gorczyca, Agnieszka; Ziora, Katarzyna; Oświęcimska, Joanna

    2012-01-01

    Childhood autism is a neurodevelopmental disorder characterized by impairments in social interactions, verbal and non-verbal communication and by a pattern of stereotypical behaviors and interests. The aim of this study was to estimate the dysmorphic facial features of children with autism and children with Asperger syndrome. The examination was conducted on 60 children (30 with childhood autism and 30 with Asperger syndrome). The photo anthropometric method used in this study followed the protocol established by Stengel-Rutkowski et al. The performed statistical analysis showed that in patients with childhood autism, the anteriorly rotated ears and the long back of the nose appeared more often. In the group of children with autism, there was a connection between the amount of dysmorphies and the presence of some somatic diseases in the first-degree relatives. There was also a connection between the motor coordination and the age the child began to walk. In patients with childhood autism, there were certain dysmorphies (like the anterior rotated ears and the long back of the nose) which appeared more often. Although the connection was not statistically significant, it seemed to concur with data from the literature. Formulation of the other conclusions would require broader studies e.g. dealing with a familial analysis of dysmorphic features.

  13. The precautionary principle as a provisional instrument in environmental policy: The Montreal Protocol case study

    International Nuclear Information System (INIS)

    Jacobs, J. Roger

    2014-01-01

    Highlights: • I examine whether a policy invoked under the Precautionary Principle can move beyond provisional status. • I review the certainty of conclusions based upon the Global Ozone Research and Monitoring Project. • There is high certainty that anthropogenic ozone depletion has health consequences in polar regions. • Current research focuses on long term projections of risk that perpetuates high uncertainty. • Establishment of a community to generate Assessments acts to perpetuate the period of uncertainty. - Abstract: Environmental studies identify possible threats to the health of the public or the environment when the scientific certainty of risk is low, but the potential cost is high. Governments may respond by invoking the Precautionary Principle, holding that scientific certainty is not required to take actions that reduce possible risk. EU guidelines suggest that precautionary measures remain provisional until sufficient scientific certainty is generated. Here I study the Scientific Assessments produced for the Montreal Protocol, and the scientific community that generates them, and ask whether a long-standing program of scientific investigation and monitoring can generate sufficient scientific certainty to move beyond dependence on the Precautionary Principle. When the Montreal Protocol was ratified, many scientists strongly suspected that anthropogenic substances like chlorofluorocarbons were depleting stratospheric ozone. Although the risk was uncertain, the perceived cost to public health of ozone depletion was high. A quarter century after formulating the Montreal Protocol, science can define the conditions for ozone depletion with great certainty, but uncertainty remains in determining the scale and distribution of the attributable increase in damaging ultra-violet (UV) radiation. Organisations, such as NASA, and scientists that contribute to the Scientific Assessments comprise the community in which the scientific consensus of risk is

  14. Prediction of Ovarian Hyperstimulation Syndrome in Patients Treated with Corifollitropin alfa or rFSH in a GnRH Antagonist Protocol.

    Directory of Open Access Journals (Sweden)

    Georg Griesinger

    Full Text Available What is the threshold for the prediction of moderate to severe or severe ovarian hyperstimulation syndrome (OHSS based on the number of growing follicles ≥ 11 mm and/or estradiol (E2 levels?The optimal threshold of follicles ≥11 mm on the day of hCG to identify those at risk was 19 for both moderate to severe OHSS and for severe OHSS. Estradiol (E2 levels were less prognostic of OHSS than the number of follicles ≥ 11 mm.In comparison to long gonadotropin-releasing hormone (GnRH agonist protocols, the risk of severe OHSS is reduced by approximately 50% in a GnRH antagonist protocol for ovarian stimulation prior to in vitro fertilisation (IVF, while the two protocols provide equal chances of pregnancy per initiated cycle. Nevertheless, moderate to severe OHSS may still occur in GnRH antagonist protocols if human chorionic gonadotropin (hCG is administered to trigger final oocyte maturation, especially in high responder patients. Severe OHSS following hCG trigger may occur with an incidence of 1-2% in a relatively young (aged 18 to 36 years IVF population treated in a GnRH-antagonist protocol.From the Engage, Ensure and Trust trials, in total, 2,433 women who received hCG for oocyte maturation and for whom the number of follicles ≥ 11 mm and the level of E2 on the day of hCG administration were known were included in the analyses.The threshold for OHSS prediction of moderate and severe OHSS was assessed in women treated with corifollitropin alfa or daily recombinant follicle stimulation hormone (rFSH in a gonadotropin-releasing hormone (GnRH-antagonist protocol. Receiver operating characteristics curve analyses for moderate to severe OHSS and severe OHSS were performed on the combined dataset and the sensitivity and specificity for the optimal threshold of number of follicles ≥ 11 mm, E2 levels on the day of (hCG, and a combination of both, were determined.The optimal threshold of follicles ≥ 11 mm on the day of hCG to identify those at

  15. Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

    Science.gov (United States)

    Napier, A David; Nolan, John J; Bagger, Malene; Hesseldal, Louise; Volkmann, Anna-Maria

    2017-11-08

    Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers. © Article author

  16. Prenatal diagnosis and prevention of toxoplasmosis in pregnant women in Northern Vietnam: study protocol.

    Science.gov (United States)

    Smit, G Suzanne A; Vu, Thi Lam Binh; Do, Trung Dung; Speybroeck, Niko; Devleesschauwer, Brecht; Padalko, Elizaveta; Roets, Ellen; Dorny, Pierre

    2017-05-25

    In Vietnam, no systematic prenatal toxoplasmosis screening is in place, and only few studies have assessed the prevalence and importance of this zoonotic parasite infection. In addition, no studies have been conducted to assess the risk factors associated with toxoplasmosis. This study protocol was developed to determine the seroprevalence of toxoplasmosis in pregnant women in Hanoi and Thai Binh, Northern Vietnam, and to evaluate the association with risk factors and congenital toxoplasmosis. The protocol was developed in a way that it could potentially evolve into a countrywide prenatal diagnosis and prevention program, with the main focus on primary prevention. The collaborating gynaecologists will invite eligible pregnant women attending antenatal care for the first time to participate in the study. At first consult, information about toxoplasmosis and its prevention will be provided. All participants will be asked to fill in a questionnaire, which is designed to analyse socio-demographic and biologically plausible risk factors associated with toxoplasmosis, and blood samples will be collected to determine the seroprevalence of toxoplasmosis in pregnant women. In case there is suspicion of a primary infection during pregnancy, the concerned women will be followed-up by the gynaecologists according to a predefined protocol. Every participant will be informed on her serological status, risk factors and prevention measures and is offered appropriate medical information and medical follow-up if required. The hypothesis is that congenital toxoplasmosis is an important but currently under-diagnosed public health problem in Vietnam. This study can strengthen sustainable control of toxoplasmosis in Vietnam, provide a protocol for prenatal diagnosis, boost overall awareness, improve the knowledge about toxoplasmosis prevention and can be essential for evidence-based health policy.

  17. Waardenburg Syndrome: A Case Study of Two Patients.

    Science.gov (United States)

    Sharma, Karan; Arora, Archana

    2015-09-01

    Waardenburg syndrome is an autosomal dominant disorder with an incidence of 1 in 40,000 that manifests with sensorineural deafness, pigmentation defects of the skin, hair and iris and various defects of neural crest-derived tissues. This genetically heterogeneous disease accounts for >2 % of the congenitally deaf population. Mutations in the EDN3, EDNRB, MITF, PAX3, SNAI2, and SOX10 genes can cause Waardenburg syndrome. We here report a case of 12 year old female who presented with chief complaint of decreased hearing in both ears and had clinical features consistent with Waardenburg syndrome. She had a distinct white forelock of hair in the midline along with striking bilateral blue iris. Also a white depigmented patch was present on the right forearm. Both eyes had bright red fundal reflex with choroidal depigmentation. Her younger brother, the second case in this study, had similar blue eyes, white forelock of hair, depigmented skin patch and choroidal depigmentation but with normal hearing. Their father had a history of premature graying of hair. All the primary care physicians coming across a child with blue eyes and white forelock of hair should get the child's hearing tested at the first instance, if not already tested. An early diagnosis and improvement of hearing impairment with timely intervention are the most important for psychological and intellectual development of children with Waardenburg syndrome.

  18. Mammalian Toxicology Testing: Problem Definition Study, AMTR Protocol/Pricing Report.

    Science.gov (United States)

    1981-04-01

    excretory . behavioral or other activity. as well as signs indicating an adverse effect on the central nervous system 54 ic Systcm, li". PROTOCOL Test No...A0-A112 832 LIFE SYSTEMS INC CLEVELAND OH F/G 6/20 MAMMA LIAN TOXICOLOGY TESTING: PROBLEM DEFINITION STUDY, AMTR PR--ETC(U) UNCLASSIFIED LSI-TR-477...S. PERFORMING ORGANIZATION NAME AND ADDRESS 10. PROGRAM ELEMENT. PROJECT, TASK AREA & WORK UNIT NUMBERS LIEL SYSTEMS , INC. ..... 24755 Highpoint Road

  19. The Protocol of Choice for Treatment of Snake Bite

    Directory of Open Access Journals (Sweden)

    Afshin Mohammad Alizadeh

    2016-01-01

    Full Text Available The aim of the current study is to compare three different methods of treatment of snake bite to determine the most efficient one. To unify the protocol of snake bite treatment in our center, we retrospectively reviewed files of the snake-bitten patients who had been referred to us between 2010 and 2014. They were contacted for follow-up using phone calls. Demographic and on-arrival characteristics, protocol used for treatment (WHO/Haddad/GF, and outcome/complications were evaluated. Patients were entered into one of the protocol groups and compared. Of a total of 63 patients, 56 (89% were males. Five, 19, and 28 patients were managed by Haddad, WHO, or GF protocols, respectively. Eleven patients had fallen into both GF and WHO protocols and were excluded. Serum sickness was significantly more common when WHO protocol was used while 100% of the compartment syndromes and 71% of deformities had been reported after GF protocol. The most important complications were considered to be deformity, compartment syndrome, and amputation and were more frequent after the use of WHO and GF protocols (23.1% versus 76.9%; none in Haddad; P = NS. Haddad protocol seems to be the best for treatment of snake-bitten patients in our region. However, this cannot be strictly concluded because of the limited sample size and nonsignificant P values.

  20. A follow-up study of heroin addicts (VEdeTTE2: study design and protocol

    Directory of Open Access Journals (Sweden)

    Lampis Fabio

    2007-03-01

    Full Text Available Abstract Background In Italy, a large cohort study (VEdeTTE1 was conducted between 1998–2001 to evaluate the effectiveness of treatments in reducing mortality and increasing treatment retention among heroin addicts. The follow-up of this cohort (VEdeTTE2 was designed to evaluate the effectiveness of treatments on long-term outcomes, such as rehabilitation and social re-integration. The purpose of this paper is to describe the protocol of the VEdeTTE2 study, and to present the results of the pilot study carried out to assess the feasibility of the study and to improve study procedures. Methods The source population for the VEdeTTE2 study was the VEdeTTE1 cohort, from which a sample of 2,200 patients, traced two or more years after enrolment in the cohort, were asked to participate. An interview investigates drug use; overdose; family and social re-integration. Illegal activity are investigated separately in a questionnaire completed by the patient. Patients are also asked to provide a hair sample to test for heroin and cocaine use. Information on treatments and HIV, HBV and HCV morbidity are obtained from clinical records. A pilot phase was planned and carried out on 60 patients. Results The results of the pilot phase pointed out the validity of the procedures designed to limit attrition: the number of traced subjects was satisfactory (88%. Moreover, the pilot phase was very useful in identifying possible causes of delays and attrition, and flaws in the instruments. Improvements to the procedures and the instruments were subsequently implemented. Sensitivity of the biological test was quite good for heroin (78% but lower for cocaine (42.3%, highlighting the need to obtain a hair sample from all patients. Conclusion In drug addiction research, studies investigating health status and social re-integration of subjects at long-term follow-up are lacking. The VEdeTTE2 study aims to investigate these outcomes at long-term follow-up. Results of the

  1. A CLINICORADIOLOGICAL STUDY OF MIDDLE LOBE SYNDROME DUE TO TUBERCULOSIS

    Directory of Open Access Journals (Sweden)

    Saurabh Karmakar

    2016-09-01

    Full Text Available BACKGROUND Although pulmonary tuberculosis is a common disease in India, tuberculosis of right middle lobe is infrequent. Tuberculosis of the right middle lobe leading to chronic collapse is a cause of Right Middle Lobe syndrome. METHODS The patients attended Pulmonary Medicine Outdoor at Era’s Lucknow Medical College, Lucknow from April 2015 to March 2016. The purpose of this study is to describe the clinicoradiological features of patients of middle lobe syndrome due to tuberculosis. All patients presented with cough with or without expectoration, fever, chest pain, haemoptysis and constitutional symptoms like loss of appetite and weight. Chest X-ray PA view revealed ill-defined opacity abutting the right cardiac border. HRCT thorax was done in each case. The diagnosis of tuberculous aetiology was based on (1 History of chronic cough and fever, not responding to antibiotic therapy and constitutional symptoms, (2 A positive tuberculin test using 2 TU of PPD RT 23 and (3 Detection of acid fast bacilli by direct smear or Mycobacterium tuberculosis by polymerase chain reaction in bronchoalveolar lavage. RESULTS Out of 10 patients, 4 (40% were males and 6 (60% were females. The mean ages of the males were 55.8 years and females were 60.8 years and overall mean age was 59 years. Most of the patients were females and belonged to the middle age and old age group. ATT was started in all the patients. CONCLUSIONS Right middle lobe syndrome predominantly affects the older population and the female gender. Although tuberculosis is a common disease in India, Middle Lobe Syndrome is a very rare presentation of the disease. Due to non-specific symptoms and usually normal chest X-ray PA view in Right Middle Lobe Syndrome, we should keep a high index of suspicion to diagnose the condition.

  2. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Directory of Open Access Journals (Sweden)

    Jimenez Carmen

    2005-10-01

    Full Text Available Abstract Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. The patients will be randomised into two groups: 1 experimental (acupuncture + physiotherapy; 2 control (TENS-placebo + physiotherapy; the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA Scale

  3. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Science.gov (United States)

    Vas, Jorge; Perea-Milla, Emilio; Mendez, Camila; Galante, Antonia Herrera; Madrazo, Fernando; Medina, Ivan; Ortega, Caridad; Olmo, Victoria; Fernandez, Francisco Perez; Hernandez, Luz; Seminario, Jose Maria; Brioso, Mauricio; Luna, Francisco; Gordo, Isabel; Godoy, Ana Maria; Jimenez, Carmen; Ruiz, Manuel Anselmo; Montes, Joaquin; Hidalgo, Alonso; Gonzalez-Quevedo, Rosa; Bosch, Pablo; Vazquez, Antonio; Lozano, Juan Vicente

    2005-01-01

    Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary

  4. The longitudinal urban cohort ageing study (LUCAS: study protocol and participation in the first decade

    Directory of Open Access Journals (Sweden)

    Dapp Ulrike

    2012-07-01

    Full Text Available Abstract Background We present concept, study protocol and selected baseline data of the Longitudinal Urban Cohort Ageing Study (LUCAS in Germany. LUCAS is a long-running cohort study of community-dwelling seniors complemented by specific studies of geriatric patients or diseases. Aims were to (1 Describe individual ageing trajectories in a metropolitan setting, documenting changes in functional status, the onset of frailty, disability and need of care; (2 Find determinants of healthy ageing; (3 Assess long-term effects of specific health promotion interventions; (4 Produce results for health care planning for fit, pre-frail, frail and disabled elderly persons; (5 Set up a framework for embedded studies to investigate various hypotheses in specific subgroups of elderly. Methods/Design In 2000, twenty-one general practitioners (GPs were recruited in the Hamburg metropolitan area; they generated lists of all their patients 60 years and older. Persons not terminally ill, without daily need of assistance or professional care were eligible. Of these, n = 3,326 (48 % agreed to participate and completed a small (baseline and an extensive health questionnaire (wave 1. In 2007/2008, a re-recruitment took place including 2,012 participants: 743 men, 1,269 women (647 deaths, 197 losses, 470 declined further participation. In 2009/2010 n = 1,627 returned the questionnaire (90 deaths, 47 losses, 248 declined further participation resulting in a good participation rate over ten years with limited and quantified dropouts. Presently, follow-up data from 2007/2008 (wave 2 and 2009/2010 (wave 3 are available. Data wave 4 is due in 2011/2012, and the project will be continued until 2013. Information on survival and need of nursing care was collected continuously and cross-checked against official records. We used Fisher’s exact test and t-tests. The study served repeatedly to evaluate health promotion interventions and concepts. Discussion LUCAS

  5. Replication protocol analysis: a method for the study of real-world design thinking

    DEFF Research Database (Denmark)

    Galle, Per; Kovacs, L. B.

    1996-01-01

    ’ is refined into a method called ‘replication protocol analysis’ (RPA), and discussed from a methodological perspective of design research. It is argued that for the study of real-world design thinking this method offers distinct advantages over traditional ‘design protocol analysis’, which seeks to capture......Given the brief of an architectural competition on site planning, and the design awarded the first prize, the first author (trained as an architect but not a participant in the competition) produced a line of reasoning that might have led from brief to design. In the paper, such ‘design replication...... the designer’s authentic line of reasoning. To illustrate how RPA can be used, the site planning case is briefly presented, and part of the replicated line of reasoning analysed. One result of the analysis is a glimpse of a ‘logic of design’; another is an insight which sheds new light on Darke’s classical...

  6. Estimations of isoprenoid emission capacity from enclosure studies: measurements, data processing, quality and standardized measurement protocols

    Science.gov (United States)

    Niinemets, Ü.; Kuhn, U.; Harley, P. C.; Staudt, M.; Arneth, A.; Cescatti, A.; Ciccioli, P.; Copolovici, L.; Geron, C.; Guenther, A.; Kesselmeier, J.; Lerdau, M. T.; Monson, R. K.; Peñuelas, J.

    2011-08-01

    The capacity for volatile isoprenoid production under standardized environmental conditions at a certain time (ES, the emission factor) is a key characteristic in constructing isoprenoid emission inventories. However, there is large variation in published ES estimates for any given species partly driven by dynamic modifications in ES due to acclimation and stress responses. Here we review additional sources of variation in ES estimates that are due to measurement and analytical techniques and calculation and averaging procedures, and demonstrate that estimations of ES critically depend on applied experimental protocols and on data processing and reporting. A great variety of experimental setups has been used in the past, contributing to study-to-study variations in ES estimates. We suggest that past experimental data should be distributed into broad quality classes depending on whether the data can or cannot be considered quantitative based on rigorous experimental standards. Apart from analytical issues, the accuracy of ES values is strongly driven by extrapolation and integration errors introduced during data processing. Additional sources of error, especially in meta-database construction, can further arise from inconsistent use of units and expression bases of ES. We propose a standardized experimental protocol for BVOC estimations and highlight basic meta-information that we strongly recommend to report with any ES measurement. We conclude that standardization of experimental and calculation protocols and critical examination of past reports is essential for development of accurate emission factor databases.

  7. Clinical implementation of an emergency department coronary computed tomographic angiography protocol for triage of patients with suspected acute coronary syndrome

    Energy Technology Data Exchange (ETDEWEB)

    Ghoshhajra, Brian B.; Staziaki, Pedro V.; Vadvala, Harshna; Kim, Phillip; Meyersohn, Nandini M.; Janjua, Sumbal A.; Hoffmann, Udo [Massachusetts General Hospital and Harvard Medical School, Cardiac MR PET CT Program, Department of Radiology (Cardiovascular Imaging) and Division of Cardiology, Boston, MA (United States); Takx, Richard A.P. [Massachusetts General Hospital and Harvard Medical School, Cardiac MR PET CT Program, Department of Radiology (Cardiovascular Imaging) and Division of Cardiology, Boston, MA (United States); University Medical Center Utrecht, Department of Radiology, Utrecht (Netherlands); Neilan, Tomas G.; Francis, Sanjeev [Massachusetts General Hospital and Harvard Medical School, Cardiac MR PET CT Program, Department of Radiology (Cardiovascular Imaging) and Division of Cardiology, Boston, MA (United States); Massachusetts General Hospital and Harvard Medical School, Division of Cardiology, Boston, MA (United States); Bittner, Daniel [Massachusetts General Hospital and Harvard Medical School, Cardiac MR PET CT Program, Department of Radiology (Cardiovascular Imaging) and Division of Cardiology, Boston, MA (United States); University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuernberg (FAU), Department of Medicine 2 - Cardiology, Erlangen (Germany); Mayrhofer, Thomas [Massachusetts General Hospital and Harvard Medical School, Cardiac MR PET CT Program, Department of Radiology (Cardiovascular Imaging) and Division of Cardiology, Boston, MA (United States); Stralsund University of Applied Sciences, School of Business Studies, Stralsund (Germany); Greenwald, Jeffrey L. [Massachusetts General Hospital and Harvard Medical School, Department of Medicine, Boston, MA (United States); Truong, Quyhn A. [Massachusetts General Hospital and Harvard Medical School, Cardiac MR PET CT Program, Department of Radiology (Cardiovascular Imaging) and Division of Cardiology, Boston, MA (United States); Weill Cornell College of Medicine, Department of Radiology, New York, NY (United States); Abbara, Suhny [Massachusetts General Hospital and Harvard Medical School, Cardiac MR PET CT Program, Department of Radiology (Cardiovascular Imaging) and Division of Cardiology, Boston, MA (United States); UT Southwestern Medical Center, Department Cardiothoracic Imaging, Dallas, TX (United States); Brown, David F.M.; Nagurney, John T. [Massachusetts General Hospital and Harvard Medical School, Department of Emergency Medicine, Boston, MA (United States); Januzzi, James L. [Massachusetts General Hospital and Harvard Medical School, Division of Cardiology, Boston, MA (United States); Collaboration: MGH Emergency Cardiac CTA Program Contributors

    2017-07-15

    To evaluate the efficiency and safety of emergency department (ED) coronary computed tomography angiography (CTA) during a 3-year clinical experience. Single-center registry of coronary CTA in consecutive ED patients with suspicion of acute coronary syndrome (ACS). The primary outcome was efficiency of coronary CTA defined as the length of hospitalization. Secondary endpoints of safety were defined as the rate of downstream testing, normalcy rates of invasive coronary angiography (ICA), absence of missed ACS, and major adverse cardiac events (MACE) during follow-up, and index radiation exposure. One thousand twenty two consecutive patients were referred for clinical coronary CTA with suspicion of ACS. Overall, median time to discharge home was 10.5 (5.7-24.1) hours. Patient disposition was 42.7 % direct discharge from the ED, 43.2 % discharge from emergency unit, and 14.1 % hospital admission. ACS rate during index hospitalization was 9.1 %. One hundred ninety two patients underwent additional diagnostic imaging and 77 underwent ICA. The positive predictive value of CTA compared to ICA was 78.9 % (95 %-CI 68.1-87.5 %). Median CT radiation exposure was 4.0 (2.5-5.8) mSv. No ACS was missed; MACE at follow-up after negative CTA was 0.2 %. Coronary CTA in an experienced tertiary care setting allows for efficient and safe management of patients with suspicion for ACS. (orig.)

  8. Experimental study of possible therapy of the acute radiation syndrome

    International Nuclear Information System (INIS)

    Willborn, M.

    1981-01-01

    These experimental studies showed that the survival time of rats, irradiated in a whole-body irradiation with 3000 rad 60 Co-gamma, can be positively influenced by the administration of an antibiotic and also by glucocorticoids. Contrary to our expectations, the combined application of the glucocorticoid and the antibiotic did not increase the survival time of the animals with gastrointestinal syndromes compared with the exclusive administration of the antibiotic. The mineral corticoid aldosterone resulted to be ineffective. (orig.) [de

  9. CLINICO PATHOLOGICAL STUDY OF NEPHROTIC SYNDROME IN ADULTS

    Directory of Open Access Journals (Sweden)

    Deepa

    2015-11-01

    Full Text Available CONTEXT: Etiology of nephrotic syndrome (NS in adults varies depending on the geographical location and is poorly studied in the Indian subcontinent. AIMS: To study the clinical features, biochemical profile and histopathological pattern of various types of glomerulonephritis in adult patients with nephrotic syndrome. METHODS AND MATERIAL: Patients (≥15 years old with nephrotic syndrome presenting to our center and undergoing a kidney biopsy from May 2009 to August 2011 were included for this study. All biopsies were subjected to light microscopy.The histopathological spectrum was analyzed according to the various clinical parameters. STATISTICAL ANALYSIS USED: Analysis was performed using SPSS software version 19.Measures obtained included percentages,medians,correlation coefficients and chi square tests. RESULTS: A total of 50 kidney biopsies were included in analysis. Twenty six(52% patients were male and twenty four(48% patients were female. The average age at presentation was 15-24 years. Among the patients, 22(44% were diagnosed with primary glomerular diseases (PGD and 4(8% with secondary glomerular diseases (SGD. The most common histological lesions was membranous nephropathy(24.4% followed by minimal change disease (MCD (17% and membranous nephropathy (MN (17%. The most common form of SGD was lupus nephritis (LN (10%. Membranous nephropathy and focal segmental glomerulosclerosis were the commonest lesions in males.Among females,membranous nephropathy was the commonest. 31(62% patients were in the age group of 15-34 yrs, 17(34% were in the age group 34- 54yrs and only 2(4% were aged above 55yrs. Among the patients, 6(12% had serum creatinine ≥1.5 mg/dL and 12(24% had either macroscopic or microscopic hematuria. CONCLUSIONS: Membranous nephropathy is still the commonest type of nephrotic syndrome in adults followed closely by focal segmental glomerulosclerosis and minimal change disease as per this study.

  10. On shaky ground - A study of security vulnerabilities in control protocols

    International Nuclear Information System (INIS)

    Byres, E. J.; Huffman, D.; Kube, N.

    2006-01-01

    The recent introduction of information technologies such as Ethernet R into nuclear industry control devices has resulted in significantly less isolation from the outside world. This raises the question of whether these systems could be attacked by malware, network hackers or professional criminals to cause disruption to critical operations in a manner similar to the impacts now felt in the business world. To help answer this question, a study was undertaken to test a representative control protocol to determine if it had vulnerabilities that could be exploited. A framework was created in which a test could express a large number of test cases in very compact formal language. This in turn, allowed for the economical automation of both the generation of selectively malformed protocol traffic and the measurement of device under test's (DUT) behavior in response to this traffic. Approximately 5000 protocol conformance tests were run against two major brands of industrial controller. More than 60 categories of errors were discovered, the majority of which were in the form of incorrect error responses to malformed traffic. Several malformed packets however, caused the device to respond or communicate in inappropriate ways. These would be relatively simple for an attacker to inject into a system and could result in the plant operator losing complete view or control of the control device. Based on this relatively small set of devices, we believe that the nuclear industry urgently needs to adopt better security robustness testing of control devices as standard practice. (authors)

  11. Conservative Treatment Protocol for Keratocystic Odontogenic Tumour: a Follow-up Study of 3 Cases

    Directory of Open Access Journals (Sweden)

    Gülsün Yildirim

    2010-07-01

    Full Text Available Background: The keratocystic odontogenic tumour is classified as a developmental cyst derived from the enamel organ or from the dental lamina. The treatment of keratocystic odontogenic tumour of the jaw remains controversial. The aim of this study was to report the outcome of our conservative treatment protocol for keratocystic odontogenic tumour.Methods: Three patients with different complaints referred to Oral and Maxillofacial Surgery Clinic, Faculty of Dentistry, Selçuk University. Initial biopsy was carried out in all patients and keratocystic odontogenic tumours was diagnosed subsequent to histopathological examination. The patients with keratocystic odontogenic tumours were treated by enucleation followed by open packing. This conservative treatment protocol was selected because of existing young aged patients. The average follow-up duration of the cases was 2 years.Results: Out of 3 cases, 2 lesions were present in mandible and 1 lesion in maxilla. There was no evidence of recurrence during follow-up. All the cases were monitored continuously with panoramic radiographs, computed tomography and clinical evaluations.Conclusions: This conservative treatment protocol for keratocystic odontogenic tumours, based on enucleation followed by open packing would be a possible choice with a view of offering low recurrence rate and low morbidity rate particularly in young patients.

  12. Efficiency of different protocols for enamel clean-up after bracket debonding: an in vitro study

    Directory of Open Access Journals (Sweden)

    Lara Carvalho Freitas Sigilião

    2015-10-01

    Full Text Available Objective: This study aimed to assess the efficiency of six protocols for cleaning-up tooth enamel after bracket debonding.Methods:A total of 60 premolars were divided into six groups, according to the tools used for clean-up: 12-blade bur at low speed (G12L, 12-blade bur at high speed (G12H, 30-blade bur at low speed (G30L, DU10CO ORTHO polisher (GDU, Renew System (GR and Diagloss polisher (GD. Mean roughness (Ra and mean roughness depth (Rz of enamel surface were analyzed with a profilometer. Paired t-test was used to assess Ra and Rz before and after enamel clean-up. ANOVA/Tukey tests were used for intergroup comparison. The duration of removal procedures was recorded. The association between time and variation in enamel roughness (∆Ra, ∆Rz were evaluated by Pearson's correlation test. Enamel topography was assessed by scanning electron microscopy (SEM.Results:In Groups G12L and G12H, original enamel roughness did not change significantly. In Groups G30L, GDU, GR and GD, a smoother surface (p < 0.05 was found after clean-up. In Groups G30L and GD, the protocols used were more time-consuming than those used in the other groups. Negative and moderate correlation was observed between time and (∆Ra, ∆Rz; Ra and (∆Ra, ∆Rz; Rz (r = - 0.445, r = - 0.475, p < 0.01.Conclusion:All enamel clean-up protocols were efficient because they did not result in increased surface roughness. The longer the time spent performing the protocol, the lower the surface roughness.

  13. The Healthy Primary School of the Future: study protocol of a quasi-experimental study

    Directory of Open Access Journals (Sweden)

    M. Willeboordse

    2016-07-01

    nature and sound scientific foundation, these integrated programmes have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society. Trial registration The study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with the reference number NCT02800616 .

  14. The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study.

    Science.gov (United States)

    Fagher, Kristina; Jacobsson, Jenny; Timpka, Toomas; Dahlström, Örjan; Lexell, Jan

    2016-01-01

    Paralympic sport provides sporting opportunities for athletes with a disability, with the Paralympic Games as the main event. Participation in sport is, however, associated with a significant risk for sustaining injuries and illnesses. Our knowledge of sports-related injuries and illnesses in Paralympic sport is very limited and there are no large-scale epidemiological cohort studies. The purpose here is to present a protocol for a prospective longitudinal study: The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS). An argument-based method for investigation of design problems was used to structure the study protocol. The primary requirement of the protocol is to allow prospective studies over time and include exposure to both training and competition. To reflect the complexity of Paralympic sport with athletes' pre-existing impairments, use of assistive equipment, pain and other and medical issues, it is required that the data collection system is specifically adapted to Paralympic sport. To allow the collection of data, at the same time as there is limited access to coaches and medical personnel, it is advantageous that data can be collected online directly from the athletes. Based on this a self-report athlete monitoring system will be developed, where the athletes can enter data weekly via their mobile phones or lap-tops. Data will be collected from around 100 Swedish Paralympic athletes for approximately 1 year, which will allow us to i) prospectively estimate the annual incidence of sports-related injuries and illnesses and ii) explore risk factors and mechanisms for sustaining sports-related injuries and illnesses based on athlete exposure and training loads. For effective implementation of injury and illness prevention measures, comprehensive epidemiological knowledge is required. This study will be the first prospective longitudinal self-report study of sports-related injuries and illnesses in Paralympic sport over a longer period

  15. Exploring interprofessional practices in rapid response systems: a case study protocol.

    Science.gov (United States)

    Allen, Emily; Jackson, Debra; Elliott, Doug

    2015-01-01

    To describe the development of a proposed case study protocol investigating interprofessional relationships in a rapid response system (RRS) in a socioculturally complex clinical environment. Suboptimal care of deteriorating ward patients remains a concern for many acute healthcare organisations. Despite the advent of RRSs, emergency response teams are not always used to their full potential. How and why interprofessional relationships influence practices associated with the care and management of ward patients at risk of clinical deterioration requires investigation. Theoretical and empirical literature describing case study research and RRSs. Review methods An integrative review approach of the literature, focusing on key terms relating to 'case study research' and 'rapid response system', provided context and informed development of the study protocol. A single-site mixed-method instrumental case study protocol was developed using methodological triangulation and a multi-level model to examine interprofessional relationships between a broad range of stakeholders. Concurrent data collection and analysis will occur using document review of clinical scenarios, non-participant observations and semi-structured interviews. Case study research is an effective method for investigating socioculturally complex clinical environments. A strength of this approach is the flexibility in the choice of methods, which allows the researcher to build the design most suitable for the subjects or phenomena being investigated. Although this flexibility may be considered a potential weakness, rigour can be achieved by application of the strategies described. Findings from this research will provide rich descriptive insights into RRS relationships and healthcare professional practices during day-to-day management of acute ward patients at risk of or experiencing clinical deterioration. Description of this structured case study research approach will also inform other researchers.

  16. Lessons learned from studying syndromic autism spectrum disorders.

    Science.gov (United States)

    Sztainberg, Yehezkel; Zoghbi, Huda Y

    2016-10-26

    Syndromic autism spectrum disorders represent a group of childhood neurological conditions, typically associated with chromosomal abnormalities or mutations in a single gene. The discovery of their genetic causes has increased our understanding of the molecular pathways critical for normal cognitive and social development. Human studies have revealed that the brain is particularly sensitive to changes in dosage of various proteins from transcriptional and translational regulators to synaptic proteins. Investigations of these disorders in animals have shed light on previously unknown pathogenic mechanisms leading to the identification of potential targets for therapeutic intervention. The demonstration of reversibility of several phenotypes in adult mice is encouraging, and brings hope that with novel therapies, skills and functionality might improve in affected children and young adults. As new research reveals points of convergence between syndromic and nonsyndromic autism spectrum disorders, we believe there will be opportunities for shared therapeutics for this class of conditions.

  17. Sjoegren's syndrome. A functional scintigraphic study of salivary glands

    International Nuclear Information System (INIS)

    Arrago, J.P.; Rain, J.D.; Rocher, F.; Vigneron, N.; Pecking, A.; Najean, Y.

    1984-01-01

    One-hundred and twenty patients with sicca syndrome, connective tissue disease or chronic graft-versus-host disease were investigated in the Saint-Louis Hospital Department of Nuclear Medicine. Technetium scanning of the salivary glands was performed in all patients. The results of the scintigraphic study were closely correlated with clinical and histological data in patients with Sjoegren's syndrome. This method, which accurately quantifies the salivary function without danger nor discomfort to the patients, has a number of advantages: (a) it is sensitive enough to detect minimal salivary gland dysfunction; (b) it differentiates between parotid gland and submandibular gland involvement demonstrates assymetry in pathological processes; (c) it helps in following up patients with Sjoegren's disease and in assessing the results of immunosuppressive or anti-inflammatory treatment [fr

  18. Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study

    Science.gov (United States)

    Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

    2016-06-01

    Objective. While promising, electroencephaloraphy based brain-computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users’ motor imagery based BCI (MI-BCI) control performance. Approach. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users’ spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Main results. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. Significance. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced

  19. Weight Status Measures Collected in the Healthy Communities Study: Protocols and Analyses.

    Science.gov (United States)

    Sroka, Christopher J; McIver, Kerry L; Sagatov, Robyn D F; Arteaga, S Sonia; Frongillo, Edward A

    2015-10-01

    The Healthy Communities Study is one of the largest studies to assess the relationship between characteristics of community programs and policies to prevent childhood obesity and obesity-related outcomes. The purpose of this paper is to describe the protocol that was developed for collecting the anthropometric data for the study and the procedures for analyzing the data. Data were collected from 2013 to 2015 and analyses will be completed by mid-2016. During in-home visits, Healthy Communities Study staff collected height, weight, and waist circumference measurements from child participants and height and weight measurements from adult participants. The protocol for obtaining these measurements was adapted from the protocol used by the National Health and Nutrition Examination Survey, with modifications to accommodate assessments conducted in homes rather than in a Mobile Examination Center. In addition to anthropometric data from in-home visits, the Healthy Communities Study collected retrospective height and weight measurements from the medical records of child participants. These data were used to calculate trajectories of BMI and BMI z-scores. The study implemented procedures for ensuring the accuracy of the in-home measurements and abstracted medical data. These procedures included automatically checking the ranges on entered data, reviewing data for end-digit patterns, and abstracting selected medical records using two independent abstractors to assess agreement. The collection of longitudinal height and weight measures will allow researchers to address several pressing questions related to how characteristics of community programs and policies are associated with obesity-related outcomes among children. Copyright © 2015 American Journal of Preventive Medicine. All rights reserved.

  20. A Study of Hypoalbuminemia and Pleural Effusionin Pediatric Nephrotic Syndrome

    Directory of Open Access Journals (Sweden)

    Tovan Perinandika

    2017-06-01

    Full Text Available Background: Nephrotic syndrome (NS is a kidney disease that is most often found in children. Hypoalbuminemia in NS can cause a decrease in oncotic pressure causing extravasation of fluid into the interstitial space. In conditions of severe hypoalbuminemia, fluid extravasation may cause occurrence of pleural effusion. The objectives of this study was to analyze the correlation between hypoalbuminemia and pleural effusion in children with NS. Methods: An analytical study was conducted on 69 medical records of pediatric nephrotic syndrome from 1 January 2008–31 December 2013 in dr. Hasan Sadikin General Hospital. Inclusion criteria were pediatric patients between 1-14 years old with NS. Exclusion criteria were patients who already had albumin transfusion, malnutrition, patients with chronic disease, and incomplete medical record information. Contingency coefficient test was carried out to discover the correlation between variables. Results: Out of 89 samples, 69 samples were included. Characteristics of the included patients are male (n=48, female (n=21, age 1–5 (n=24, 6–10 (n=22, 11–14 (n=23, mild hypoalbuminemia (n=3, moderate hypoalbuminemia (n=27, severe hypoalbuminemia (n=39, patients with pleural effusion (n=23, and non-pleural effusion (n=46. There was a significant correlation between  hypoalbuminemia and pleural effusion with p=0.000 (p<0.05 and moderate correlation (r=0.437. Conclusions: Hypoalbuminemia has correlation with pleural effusion in pediatric nephrotic syndrome. Keywords: Hypoalbuminemia, pediatric nephrotic syndrome, pleural effusion DOI: 10.15850/amj.v4n2.1075

  1. [Clinical study of area of Jiangsu province of polycystic ovarian syndrome correlation distribution of traditional Chinese medicine syndrome type and improper diet].

    Science.gov (United States)

    Feng, Yu; Gao, Yue-Ping

    2014-05-01

    Polycystic ovary syndrome (PCOS) is one of the most popular diseases in obstetrics and gynecology research at internal and abroad at present, traditional Chinese medicine(TCM)in the clinical treatment of the disease have the advantage. Clinical epidemiological study of descriptive research method this research adopts investigation, observation of TCM syndromes and improper diet through 401 cases in Jiangsu Province confirmed PCOS patients, to explore the relationship between TCM syndrome type distribution and improper diet factors, and to provide the clinical basis for further etiology of this disease research. TCM syndrome type distribution of the disease is kidney deficiency, phlegm stagnation syndrome, qi stagnation and blood stasis syndrome, syndrome of dampness heat of liver channel and is composed of 4 basic syndromes and formed complex syndrome, and the composite and syndrome type (60.85%); combined with the analysis of traditional Chinese medicine dialectical, Pure empirical syndrome this disease (46.88%), followed by the actual card (45.39%), pure deficiency is rare. Improper diet factors associated with the disease, in which improper diet with different TCM syndrome type distribution significantly related. Stagnation of phlegm dampness syndrome is the main syndrome of the disease type, improper diet factors and every syndrome PCOS type distribution is as follows: the partial eclipse fatness greasy with basic syndromes of phlegm dampness stagnation of kidney deficiency syndrome, the nephrasthenia syndrome is less; eating spicy stimulation by basic syndromes of stagnation of Qi and blood stasis; eating cold people the basic certificate type of qi stagnation and blood stasis; The diet of patients are more prone to stagnation of phlegm dampness syndrome.

  2. Where Words Fail, Music Speaks: A Mixed Method Study of an Evidence-Based Music Protocol.

    Science.gov (United States)

    Daniels, Ruby A; Torres, David; Reeser, Cathy

    2016-01-01

    Despite numerous studies documenting the benefits of music, hospice social workers are often unfamiliar with evidence-based music practices that may improve end of life care. This mixed method study tested an intervention to teach hospice social workers and chaplains (N = 10) an evidence-based music protocol. Participants used the evidence-based practice (EBP) for 30 days, recording 226 journal entries that described observations of 84 patients and their families. There was a significant increase in EBP knowledge (35%). Prompting behavioral and emotional responses, music was described frequently as a catalyst that facilitated deeper dialogue between patients, families, social workers, and chaplains.

  3. Longitudinal study of spherical refractive error in infantile nystagmus syndrome.

    Science.gov (United States)

    Healey, Natasha; McClelland, Julie F; Saunders, Kathryn J; Jackson, A Jonathan

    2014-05-01

    To explore the onset and progression of spherical refractive error in a population with infantile nystagmus syndrome. Retrospective refractive error data were obtained from 147 medical records of children with infantile nystagmus syndrome (albinism n = 98; idiopathic infantile nystagmus n = 49), attending a low vision clinic in Northern Ireland, over a 24 year period (1986-2010). Data were categorised by age to allow for comparisons with published studies. A prospective group of participants with Infantile nystagmus syndrome (INS) [n = 22 (albinism n = 18, idiopathic infantile nystagmus n = 4)] (aged 0-4) were also recruited. Cycloplegic streak retinoscopy was performed biannually, over a 3 year period. Spherical equivalent refractive error and most ametropic meridian were analysed. The mean spherical equivalent refractive errors for albinism and idiopathic infantile nystagmus groups (across all age categories) were hypermetropic, with highest levels demonstrated by the participants with albinism aged 1 ≤ 4 years (Mann-Whitney U test, p = 0.013). Mean most ametropic meridian was highest in the albinism group aged 1 ≤ 12 years (Mann-Whitney U test, p refractive errors over time. Prospective participants were hypermetropic at all visits and those with albinism had, on average, higher refractive errors than those with idiopathic infantile nystagmus (IIN). No significant correlations were noted between visual acuity and spherical equivalent refractive errors or most ametropic meridian. Hypermetropia is the most prevalent spherical refractive error in the INS population, irrespective of level of visual acuity. Individuals with infantile nystagmus syndrome fail to demonstrate typical patterns of emmetropisation, particularly in the presence of albinism. © 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists.

  4. A comparative study of routing protocols of heterogeneous wireless sensor networks.

    Science.gov (United States)

    Han, Guangjie; Jiang, Xu; Qian, Aihua; Rodrigues, Joel J P C; Cheng, Long

    2014-01-01

    Recently, heterogeneous wireless sensor network (HWSN) routing protocols have drawn more and more attention. Various HWSN routing protocols have been proposed to improve the performance of HWSNs. Among these protocols, hierarchical HWSN routing protocols can improve the performance of the network significantly. In this paper, we will evaluate three hierarchical HWSN protocols proposed recently--EDFCM, MCR, and EEPCA--together with two previous classical routing protocols--LEACH and SEP. We mainly focus on the round of the first node dies (also called the stable period) and the number of packets sent to sink, which is an important aspect to evaluate the monitoring ability of a protocol. We conduct a lot of experiments and simulations on Matlab to analyze the performance of the five routing protocols.

  5. Optional Protocol on the Sale of Children, Child Prostitution and Child Pornography: A Study on Iran's Accession to the Protocol

    Directory of Open Access Journals (Sweden)

    Seyyed Masoud Noori

    2007-03-01

    Full Text Available Reviewing this Protocol and comparing it with Iranian law, this article seeks to respond to the question of the possible consequences of Iran's accession to the Protocol. Examining the content of the Protocol shows that Iran's accession not only is not in contrary to moral principles, the statutes and the practical procedures of Iranian Government; but it will rather promote Iranian position in the international sphere. بسیاری از پیمان‌نامه‌های مهم بین‏المللی دارای اسناد ضمیمه‌ای به نام پروتکل هستند که موضوعات سند اصلی را تشریح می‌کنند. برای کنوانسیون حقوق کودک نیز که بیش از هر سند بین‌المللی به امضای کشورها رسیده، دو پروتکل الحاقی تدوین شده است: یکی دربارة بکارگیری کودکان در مناقشات مسلّحانه و دیگری دربارة خرید و فروش، خود فروشی و هرزه‌نگاری کودکان. مجلس شورای اسلامی الحاق جمهوری اسلامی ایران به پیمان‌نامة حقوق کودک را تصویب کرده است. یکی از توصیه‌های کمیتة حقوق کودک هنگام بررسی دومین گزارش ادواری ایران این بود که ایران پروتکل‌های مذکور را تصویب کند. مجلس شورای اسلامی در جلسه 9/5/1386 الحاق دولت ایران به پروتکل مربوط به فروش، فحشاء و هرزه‌نگاری کودکان را تصویب کرده است. مقاله حاضر با مروری بر این پروتکل و مطالعة تطبیقی آن با قوانین موضوعة ایران، در صدد است این پرسش را پاسخ گوید که اجابت درخواست کمیتة حقوق کودک و امضای آن پروتکل توسط دولت ایران، چه نتایجی در

  6. Pediatric restless legs syndrome diagnostic criteria: an update by the International Restless Legs Syndrome Study Group.

    Science.gov (United States)

    Picchietti, Daniel L; Bruni, Oliviero; de Weerd, Al; Durmer, Jeffrey S; Kotagal, Suresh; Owens, Judith A; Simakajornboon, Narong

    2013-12-01

    Specific diagnostic criteria for pediatric restless legs syndrome (RLS) were published in 2003 following a workshop at the National Institutes of Health. Due to substantial new research and revision of the adult RLS diagnostic criteria, a task force was chosen by the International Restless Legs Syndrome Study Group (IRLSSG) to consider updates to the pediatric diagnostic criteria. A committee of seven pediatric RLS experts developed a set of 15 consensus questions to review, conducted a comprehensive literature search, and extensively discussed potential revisions. The committee recommendations were approved by the IRLSSG executive committee and reviewed by the IRLSSG membership. The pediatric RLS diagnostic criteria were simplified and integrated with the newly revised adult RLS criteria. Specific recommendations were developed for pediatric application of the criteria, including consideration of typical words used by children to describe their symptoms. Pediatric aspects of differential diagnosis, comorbidity, and clinical significance were then defined. In addition, the research criteria for probable and possible pediatric RLS were updated and criteria for a related condition, periodic limb movement disorder (PLMD), were clarified. Revised diagnostic criteria for pediatric RLS have been developed, which are intended to improve clinical practice and promote further research. Copyright © 2013 The Authors. Published by Elsevier B.V. All rights reserved.

  7. An exploratory study of cannabis withdrawal among Indigenous Australian prison inmates: study protocol

    OpenAIRE

    Rogerson, Bernadette; Copeland, Jan; Buttner, Petra; Bohanna, India; Cadet-James, Yvonne; Sarnyai, Zoltan; Clough, Alan R

    2013-01-01

    Introduction Cannabis use and dependence is a serious health and criminal justice issue among incarcerated populations internationally. Upon abrupt, enforced cessation of cannabis, prisoners may suffer irritability and anger that can lead to threatening behaviour, intimidation, violence, sleep disturbances and self-harm. Cannabis withdrawal syndrome, proposed for inclusion in the Diagnostic and Statistical Manual of Mental Disorders in 2013, has not been examined in Indigenous populations. Ow...

  8. Radiation Dose Index of Renal Colic Protocol CT Studies in the United States

    Science.gov (United States)

    Lukasiewicz, Adam; Bhargavan-Chatfield, Mythreyi; Coombs, Laura; Ghita, Monica; Weinreb, Jeffrey; Gunabushanam, Gowthaman; Moore, Christopher L.

    2016-01-01

    Purpose To determine radiation dose indexes for computed tomography (CT) performed with renal colic protocols in the United States, including frequency of reduced-dose technique usage and any institutional-level factors associated with high or low dose indexes. Materials and Methods The Dose Imaging Registry (DIR) collects deidentified CT data, including examination type and dose indexes, for CT performed at participating institutions; thus, the DIR portion of the study was exempt from institutional review board approval and was HIPAA compliant. CT dose indexes were examined at the institutional level for CT performed with a renal colic protocol at institutions that contributed at least 10 studies to the registry as of January 2013. Additionally, patients undergoing CT for renal colic at a single institution (with institutional review board approval and informed consent from prospective subjects and waiver of consent from retrospective subjects) were studied to examine individual renal colic CT dose index patterns and explore relationships between patient habitus, demographics, and dose indexes. Descriptive statistics were used to analyze dose indexes, and linear regression and Spearman correlations were used to examine relationships between dose indexes and institutional factors. Results There were 49 903 renal colic protocol CT examinations conducted at 93 institutions between May 2011 and January 2013. Mean age ± standard deviation was 49 years ± 18, and 53.9% of patients were female. Institutions contributed a median of 268 (interquartile range, 77–699) CT studies. Overall mean institutional dose-length product (DLP) was 746 mGy · cm (effective dose, 11.2 mSv), with a range of 307–1497 mGy · cm (effective dose, 4.6–22.5 mSv) for mean DLPs. Only 2% of studies were conducted with a DLP of 200 mGy · cm or lower (a “reduced dose”) (effective dose, 3 mSv), and only 10% of institutions kept DLP at 400 mGy · cm (effective dose, 6 mSv) or less in at

  9. Study protocol. A prospective cohort study of unselected primiparous women: the pregnancy outcome prediction study

    Directory of Open Access Journals (Sweden)

    White Ian R

    2008-11-01

    Full Text Available Abstract Background There have been dramatic changes in the approach to screening for aneuploidy over the last 20 years. However, the approach to screening for other complications of pregnancy such as intra-uterine growth restriction, pre-eclampsia and stillbirth remains largely unchanged. Randomised controlled trials of routine application of high tech screening methods to the general population have generally failed to show improvement in outcome. We have previously reviewed this and concluded it was due, in large part, to poor performance of screening tests. Here, we report a study design where the primary aim is to generate clinically useful methods to screen women to assess their risk of adverse pregnancy outcome. Methods/design We report the design of a prospective cohort study of unselected primiparous women recruited at the time of their first ultrasound scan. Participation involves serial phlebotomy and obstetric ultrasound at the dating ultrasound scan (typically 10–14 weeks, 20 weeks, 28 weeks and 36 weeks gestation. In addition, maternal demographic details are obtained; maternal and paternal height are measured and maternal weight is serially measured during the pregnancy; maternal, paternal and offspring DNA are collected; and, samples of placenta and membranes are collected at birth. Data will be analysed as a prospective cohort study, a case-cohort study, and a nested case-control study. Discussion The study is expected to provide a resource for the identification of novel biomarkers for adverse pregnancy outcome and to evaluate the performance of biomarkers and serial ultrasonography in providing clinically useful prediction of risk.

  10. Computerized method of visual acuity testing: adaptation of the amblyopia treatment study visual acuity testing protocol.

    Science.gov (United States)

    Moke, P S; Turpin, A H; Beck, R W; Holmes, J M; Repka, M X; Birch, E E; Hertle, R W; Kraker, R T; Miller, J M; Johnson, C A

    2001-12-01

    To report a computerized method for determining visual acuity in children using the Amblyopia Treatment Study visual acuity testing protocol. A computerized visual acuity tester was developed that uses a programmed handheld device that uses the Palm operating system (Palm, Inc, Santa Clara, California). The handheld device communicates with a personal computer running a Linux operating system and 17-inch monitor. At a test distance of 3 m, single letters can be displayed from 20/800 to 20/12. A C program on the handheld device runs the Amblyopia Treatment Study visual acuity testing protocol. Using this method, visual acuity was tested in both the right and left eyes, and then the testing was repeated in 156 children age 3 to 7 years at four clinical sites. Test-retest reliability was high (r =.92 and 0.95 for and right and left eyes, respectively), with 88% of right eye retests and 94% of left eye retests within 0.1 logarithm of minimal angle of resolution (logMAR) units of the initial test. The 95% confidence interval for an acuity score was calculated to be the score +/- 0.13 logMAR units. For a change between two acuity scores, the 95% confidence interval was the difference +/- 0.19 logMAR units. We have developed a computerized method for measurement of visual acuity. Automation of the Amblyopia Treatment Study visual acuity testing protocol is an effective method of testing visual acuity in children 3 to 7 years of age.

  11. The Bakery Protocol: A Comparative Case-Study in Formal Verification

    NARCIS (Netherlands)

    Griffioen, D.; Korver, H.

    Groote and the second author verified (a version of) the Bakery Protocol in μCRL. Their process-algebraic verification is rather complex compared to the protocol. Now the question is: How do other verification techniques perform on this protocol? In this paper we present a new correctness proof by

  12. Pilot study: Assessing the effect of continual position monitoring technology on compliance with patient turning protocols

    OpenAIRE

    Schutt, Suann Cirigliano; Tarver, Christine; Pezzani, Michelle

    2017-01-01

    Abstract Aim The study aim was to evaluate if continual patient position monitoring, taking into account self‐turns and clinician‐assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. Background While patient turning has clinical benefits, current models to help staff remember to turn patients, such as “turn clocks” and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2‐hr windo...

  13. GnRH antagonist versus long agonist protocols in IVF

    DEFF Research Database (Denmark)

    Lambalk, C B; Banga, F R; Huirne, J A

    2017-01-01

    was not the only variable between the compared study arms. OBJECTIVE AND RATIONALE: The aim of the current study was to compare GnRH antagonist protocols versus standard long agonist protocols in couples undergoing IVF or ICSI, while accounting for various patient populations and treatment schedules. SEARCH......BACKGROUND: Most reviews of IVF ovarian stimulation protocols have insufficiently accounted for various patient populations, such as ovulatory women, women with polycystic ovary syndrome (PCOS) or women with poor ovarian response, and have included studies in which the agonist or antagonist...... METHODS: The Cochrane Menstrual Disorders and Subfertility Review Group specialized register of controlled trials and Pubmed and Embase databases were searched from inception until June 2016. Eligible trials were those that compared GnRH antagonist protocols and standard long GnRH agonist protocols...

  14. Iatrogenic newborn weight loss: knowledge translation using a study protocol for your maternity setting

    Directory of Open Access Journals (Sweden)

    Woodend A Kirsten

    2011-08-01

    Full Text Available Abstract Background In our original study of newborn weight loss, we determined there were positive correlations among newborn weight loss, neonatal output, and the IV fluids mothers received before their babies' birth. Basically, an increase in maternal IV fluids is correlated to an increase in neonatal output and newborn weight loss. When assessing newborn weight change, our recommendation is to change baseline from birth weight to a weight measured at 24 hours. The purpose of this paper is to provide a protocol for clinicians to collect and analyze data from their own maternity site to determine if the newborns experience such an iatrogenic weight loss and to make decisions about how to assess newborn weight changes. Methods We recommend a prospective observational study with data collected about maternal fluids, neonatal output, and newborn weight measurements. The methods we suggest include specifics about recruitment, data collection, and data analysis. Discussion Quality assurance and research ethics considerations are described. We also share practical information that we learned from our original study. Ultimately, to encourage knowledge translation and research uptake, we provide a protocol and sound advice to do a research study in your maternity setting.

  15. Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols

    Energy Technology Data Exchange (ETDEWEB)

    Verger, Antoine; Karcher, Gilles [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Djaballah, Wassila [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Fourquet, Nicolas [Clinique Pasteur, Toulouse (France); Rouzet, Francois; Le Guludec, Dominique [AP-HP, Hopital Bichat, Department of Nuclear Medicine, Paris (France); INSERM U 773 Inserm and Denis Diderot University, Paris (France); Koehl, Gregoire; Roch, Veronique [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Imbert, Laetitia [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Centre Alexis Vautrin, Department of Radiotherapy, Vandoeuvre (France); Poussier, Sylvain [INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Fay, Renaud [INSERM, Centre d' Investigation Clinique CIC-P 9501, Nancy (France); Marie, Pierre-Yves [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); INSERM U961, Nancy (France); Hopital de Brabois, CHU-Nancy, Medecine Nucleaire, Vandoeuvre-les-Nancy (France)

    2013-03-15

    The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving {sup 201}Tl (n = 120) or {sup 99m}Tc-sestamibi injected at low dose at stress ({sup 99m}Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ({sup 99m}Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, {sup 201}Tl 92 %, {sup 99m}Tc-Low 86 %, {sup 99m}Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p < 0.001). This larger extent was mainly observed in 50 obese patients who were in the {sup 201}Tl or {sup 99m}Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 {+-} 101 kcounts) and dramatically enhanced with CZT SPECT (+279 {+-} 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT. (orig.)

  16. Estimations of isoprenoid emission capacity from enclosure studies: measurements, data processing, quality and standardized measurement protocols

    Directory of Open Access Journals (Sweden)

    Ü. Niinemets

    2011-08-01

    Full Text Available The capacity for volatile isoprenoid production under standardized environmental conditions at a certain time (ES, the emission factor is a key characteristic in constructing isoprenoid emission inventories. However, there is large variation in published ES estimates for any given species partly driven by dynamic modifications in ES due to acclimation and stress responses. Here we review additional sources of variation in ES estimates that are due to measurement and analytical techniques and calculation and averaging procedures, and demonstrate that estimations of ES critically depend on applied experimental protocols and on data processing and reporting. A great variety of experimental setups has been used in the past, contributing to study-to-study variations in ES estimates. We suggest that past experimental data should be distributed into broad quality classes depending on whether the data can or cannot be considered quantitative based on rigorous experimental standards. Apart from analytical issues, the accuracy of ES values is strongly driven by extrapolation and integration errors introduced during data processing. Additional sources of error, especially in meta-database construction, can further arise from inconsistent use of units and expression bases of ES. We propose a standardized experimental protocol for BVOC estimations and highlight basic meta-information that we strongly recommend to report with any ES measurement. We conclude that standardization of experimental and calculation protocols and critical examination of past reports is essential for development of accurate emission factor databases.

  17. Postpartum physiology, psychology and paediatric follow up study (P4 Study) - Study protocol.

    Science.gov (United States)

    Davis, Gregory K; Roberts, Lynne; Mangos, George; Henry, Amanda; Pettit, Franziska; O'Sullivan, Anthony; Homer, Caroline S E; Craig, Maria; Harvey, Samuel B; Brown, Mark A

    2016-10-01

    Women who have had hypertension in pregnancy are at greater risk of long term cardiovascular disease (CVD). Little is known about their cardiovascular risk postpartum or the effects on the woman's mental health and the outcomes of their infants. In this project we will study the physiological and psychological health of women and the physical health and development of their infants six months, two years and five years after birth. We will establish normal blood pressure (BP) and metabolic function for women who were normotensive in pregnancy and use these to assess women who had gestational hypertension (GH) or preeclampsia (PE). Women will be asked to participate if they have given birth in the preceding six months. They will be excluded if they had diabetes, hypertension, renal or other serious maternal disease prior to pregnancy or congenital anomaly in the pregnancy. We will recruit 292 women who were normotensive and their babies, 100 who had GH and 100 who had PE and their babies. They will be assessed at six months, two and five years after birth. At each assessment mothers will have their blood pressure (BP) assessed peripherally with a liquid crystal sphygmomanometer and 24h ambulatory blood pressure monitoring (ABPM), and centrally with non-invasive applanation tonometry. Additional physiological testing will include: body composition; energy balance; vascular compliance; cardiac function; liver and renal function, lipids and biochemistry; glucose and insulin; and urinalysis. Psychological status will be assessed with validated self-report questionnaires for depression, anxiety, post-traumatic stress disorder (PTSD) and mother-infant bonding. The babies will have a medical examination by a paediatrician at each assessment. Their behavioural development will be assessed with an Ages and Stages Questionnaire completed by their mother at each assessment and a developmental assessment by a child psychologist at two and five years. This study will re

  18. The POWERPLAY workplace physical activity and nutrition intervention for men: Study protocol and baseline characteristics.

    Science.gov (United States)

    Caperchione, Cristina M; Sharp, Paul; Bottorff, Joan L; Stolp, Sean; Oliffe, John L; Johnson, Steven T; Jones-Bricker, Margaret; Errey, Sally; Christian, Holly; Healy, Theresa; Medhurst, Kerensa; Lamont, Sonia

    2015-09-01

    Many health promotion programs hold little "manly" appeal and as a consequence fail to influence men's self-health practices. That said, the workplace can provide an important delivery point for targeted health promotion programs by supporting positive aspects of masculinity. The purpose of this article is to, a) describe the intervention design and study protocol examining the feasibility of a gender-sensitive workplace health promotion intervention focusing on physical activity and healthy eating in male-dominated rural and remote worksites, and b) report baseline findings. This study is a non-randomized quasi-experimental intervention trial examining feasibility and acceptability, and estimated intervention effectiveness. The POWERPLAY program was developed through consultations with men and key workplace personnel, and by drawing on a growing body of men's health promotion research. The program includes masculine print-based messaging, face-to-face education sessions, friendly competition, and self-monitoring concerning physical activity and healthy eating. Male participants (N=139) were recruited from four worksites in northern British Columbia, Canada. Baseline data were collected via computer assisted telephone interview (CATI) survey which assessed physical activity, dietary behavior and workplace environment. This protocol will also be used to collect follow-up data at 6months. A process evaluation, using semi-structured interviews, will be undertaken to assess feasibility and acceptability among participants and worksites. Study outcomes will guide intervention refinement and further testing in a sufficiently powered randomized control trial. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  19. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

    Science.gov (United States)

    Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-06-27

    Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

  20. Asperger syndrome related suicidal behavior: two case studies.

    Science.gov (United States)

    Kocourkova, Jana; Dudova, Iva; Koutek, Jiri

    2013-01-01

    Asperger syndrome hinders adaptation to developmental challenges during childhood and adolescence, particularly with regard to interpersonal relationships. Individuals with Asperger syndrome display lack of empathy and limited ability to understand social and emotional exchanges with other people. Individuals with Asperger syndrome are significantly exposed to the risk of suicidal behavior, especially during adolescence. The authors describe cases of suicidal behavior in two adolescent boys with Asperger syndrome.

  1. Dancing with Down Syndrome: A Phenomenological Case Study

    Science.gov (United States)

    Reinders, Nicole; Bryden, Pamela J.; Fletcher, Paula C.

    2015-01-01

    "Dance for individuals with Down syndrome has many benefits; however, there is little research on this topic." Down syndrome is the most common "genetic condition," resulting in psychological, physical, and social impairments. There is research to suggest that dance may be a beneficial activity for people with Down syndrome;…

  2. Pilot study: Assessing the effect of continual position monitoring technology on compliance with patient turning protocols.

    Science.gov (United States)

    Schutt, Suann Cirigliano; Tarver, Christine; Pezzani, Michelle

    2018-01-01

    The study aim was to evaluate if continual patient position monitoring, taking into account self-turns and clinician-assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. While patient turning has clinical benefits, current models to help staff remember to turn patients, such as "turn clocks" and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2-hr windows (such as turning on "even" hours) rather than on individual patient activity, including self-turns. This is a first inpatient, non-randomized, pre-/postintervention study. Data collection occurred from May 2013-February 2014 on a 39-bed medical unit in a community hospital. Baseline patient turning data were recorded by a sensor; however, the patient data were not displayed at the nurses' station to establish compliance with the hospital's turning protocol. Postintervention, patient position information was wirelessly displayed on nurses' station computer monitors in real time. A Student t test was used to compare baseline to postintervention "mean time in compliance." Data from 138 patients ( N  =   7,854 hr of monitoring) were collected. The baseline phase yielded 4,322 hr of position monitoring data and the postintervention phase yielded 3,532 hr of data. Statistically significant improvement was demonstrated in the percentage of time a patient's position changed at least every 2 hr from baseline to postintervention.

  3. Effect of Iranian Ministry of Health protocols on cesarean section rate: a quasi-experimental study.

    Science.gov (United States)

    Yavangi, Mahnaz; Sohrabi, Mohammad-Reza; Alishahi Tabriz, Amir

    2013-05-29

    High Cesarean section rate is a major health problem in developing countries. This study was established to evaluate the effectiveness of Iranian Ministry of Health and Medical Education protocols on Cesarean section rate trend. Through a non-concurrent controlled quasi-experimental study, Cesarean section rate in Shohada-e-Tajrish and Taleghani hospitals in Tehran was compared during 2008-2009. Intervention group included 578 participants hospitalized because of premature rupture of membranes, prolonged pregnancy, pre-eclampsia, intra-uterine growth retardation, vaginal bleeding and premature labor in first and second trimester underwent interventions based on MOHME new protocol. On the other hand 594 cases as control group were selected during the same time before the intervention and underwent routine treatments. Descriptive statics, t-test, chi square and univariate analysis were used when appropriate. Basic characteristics in two groups had no statistically significant difference. Cesarean section applied for 360 (67.8%) women in case group and on the other hand, 270 (48.8%) Cesarean sections were done for control group (PComplication of pregnancies had increased by 6% in intervention group (PCesarean section rate. Providing appropriate service may increase the ability of service providers to find more indications for Cesarean section.

  4. Pilot study of a robotic protocol to treat shoulder subluxation in patients with chronic stroke

    Science.gov (United States)

    2013-01-01

    Background Shoulder subluxation is a frequent complication of motor impairment after stroke, leading to soft tissue damage, stretching of the joint capsule, rotator cuff injury, and in some cases pain, thus limiting use of the affected extremity beyond weakness. In this pilot study, we determined whether robotic treatment of chronic shoulder subluxation can lead to functional improvement and whether any improvement was robust. Methods 18 patients with chronic stroke (3.9 ± 2.9 years from acute stroke), completed 6 weeks of robotic training using the linear shoulder robot. Training was performed 3 times per week on alternate days. Each session consisted of 3 sets of 320 repetitions of the affected arm, and the robotic protocol alternated between training vertical arm movements, shoulder flexion and extension, in an anti-gravity plane, and training horizontal arm movements, scapular protraction and retraction, in a gravity eliminated plane. Results Training with the linear robot improved shoulder stability, motor power, and resulted in improved functional outcomes that were robust 3 months after training. Conclusion In this uncontrolled pilot study, the robotic protocol effectively treated shoulder subluxation in chronic stroke patients. Treatment of subluxation can lead to improved functional use of the affected arm, likely by increasing motor power in the trained muscles. PMID:23914834

  5. Total sleep deprivation study in delayed sleep-phase syndrome.

    Science.gov (United States)

    Manzar, Md Dilshad; Hameed, Unaise Abdul; Hussain, M Ejaz

    2011-04-01

    Delayed sleep-phase syndrome (DSPS) is characterized by delayed sleep onset against the desired clock time. It often presents with symptoms of sleep-onset insomnia or difficulty in awakening at the desired time. We report the finding of sleep studies after 24 h total sleep deprivation (TSD) in a 28-year-old DSPS male patient. He had characteristics of mild chronic DSPS, which may have been precipitated by his frequent night shift assignments. The TSD improved the patients sleep latency and efficiency but all other sleep variables showed marked differences.

  6. Studies of microparticles in patients with the antiphospholipid syndrome (APS).

    Science.gov (United States)

    Vikerfors, A; Mobarrez, F; Bremme, K; Holmström, M; Ågren, A; Eelde, A; Bruzelius, M; Antovic, A; Wallén, H; Svenungsson, E

    2012-06-01

    To study circulating platelet, monocyte and endothelial microparticles (PMPs, MMPs and EMPs) in patients with antiphospholipid syndrome (APS) in comparison with healthy controls. Fifty-two patients with APS and 52 healthy controls were investigated. MPs were measured on a flow cytometer (Beckman Gallios) and defined as particles sized APS patients versus controls (p APS patients. We observed a high number of EMPs expressing TF in APS patients. The numbers of MMPs and total EMPs were also higher as compared with healthy controls but in contrast to previous reports, the number of PMPs did not differ between groups.

  7. Comparative study of agar gel immunodiffusion (AGID protocols for the diagnosis of equine infectious anemia in Brazil

    Directory of Open Access Journals (Sweden)

    Fernanda Gonçalves Oliveira

    2014-02-01

    Full Text Available To evaluate the Equine Infectious Anemia (EIA agar gel immunodiffusion (AGID protocols, two different kits commercially available in Brazil were used: an imported kit (kit A and a domestically produced kit (kit B. Kit A was submitted to the protocols recommended by the World Organization for Animal Health (OIE and the protocol recommended by the Ministério da Agricultura Pecuária e Abastecimento (MAPA. Kit B, the Brazilian kit, was submitted only to the MAPA-recommended protocol and was used as a reference in this study. A total of 345 equid serum samples, including field samples, serum sets from official laboratories and a weak positive serum control from National Veterinary Services Laboratories (NVSL, were used. Parameters such as the sensitivity of kit A in the two protocols, the detection limit of kits and the occurrence of nonspecific reactions or non-identity were evaluated. When Kit A was used for an AGID procedure performed according to the OIE-recommended protocol, the kit demonstrated good agreement with kit B and 99 % relative sensitivity. However, when kit A was processed according to the MAPA-recommended protocol, it failed to detect 1.16 % of weak positive samples and its relative sensitivity decreased to 96 %. The detection limit of kit A was lower than the detection limit of kit B for weak positive samples in both protocols. The occurrence of nonidentity reactions was higher with kit B than with kit A. The training of veterinarians to ensure the correct execution of the AGID test protocol should be intensified in Brazil.

  8. Metabolic Syndrome among Women: A Study from Bursa Turkey

    Directory of Open Access Journals (Sweden)

    Hasan Orhan

    2011-08-01

    Full Text Available AIM: Obesity is one of the risk factors of metabolic syndrome (MetS and its prevalence is rapidly increasing in Turkey. The purpose of this study was to assess the prevalence of MetS and obesity among women aged 20 years and older. METHOD: This is a cross- sectional study, undergone in a primary health care setting in Bursa /Turkey in the year 2008. A total of 807 women were included in the study. Body weight, height, waist circumference, blood pressure, total and HDL cholesterol, fasting plasma glucose and triglyceride levels were measured. Metabolic Syndrome definition was made according to the International Diabetes Federation (IDF criteria. RESULTS: The mean age was 42.713.2 years, 96.4% were married, 50.7% had education of less than 8 years, 93.7% were housewives and 85.3% had a monthly family income of $650 or less. The prevalence of MetS and abdominal obesity were 17.5 % and 87.7% respectively. Those with diabetes mellitus and elevated plasma lipids had increased risk of developing MetS 11.3 and 4.5 times more than those without these situations respectively. The risk of MetS increases with age and increasing BMI. CONCLUSION: Obesity is an alarming risk factor for the development of MetS in our study group. [TAF Prev Med Bull 2011; 10(4.000: 421-432

  9. Development of West syndrome in a patient with Reye syndrome: a case study.

    Science.gov (United States)

    Garcia de Alba, G O; Gamboa Marrufo, J D; Valencia Mayoral, P; Delgadillo, J F

    1989-04-01

    We report the case of a 3 month old female with a diagnosis of Reye Syndrome, confirmed with laboratory exams. Three months after apparently recovering from the acute clinical picture, the patient developed massive spasms and psychomotor delay with an EEG tracing typical of hypsarrythmia, the classic triade which suggests West Syndrome.

  10. [Diogenes's syndrome: an observatory study in a Paris district].

    Science.gov (United States)

    Monfort, Jean-Claude; Hugonot-Diener, Laurence; Devouche, Emmanuel; Wong, Catherine; Péan, Isabelle

    2010-06-01

    Diogenes syndrome, DS, is a behavioral disorder affecting more often older adults. It is a controversial syndrome with at least 4 almost permanent symptoms: no request from the subject although he possesses nothing; unusual relationship with objects (hoarding of rubbish, or nothing in the house); unusual relationship with people (misanthropy) and extreme self-neglect. Difficulties in taking care of such subjects has conducted the socio-medical team to carry out a descriptive study to find out if these subjects had a pathological state or not. A retrospective observatory survey based on 600 questionnaires sent to medical and social workers to describe potential cases of DS. 136 questionnaires concerning 121 subjects have been completed by 53 professional workers, which represent 1.6 case for 10,000 individuals. Mean age of the subjects was 77.8 +/- 9.9 years (range 52 to 95); 71% were women. All socio professional categories were represented among the patients. Half of the patients had a psychiatric disorder and 26% a dementia; 7% were alcohol addicts. One forth of DS had no associated mental pathology, and could be primary, but a "queer" personality was reported in these cases and a traumatism during childhood in 12%. The variety of the clinical typology may explain the controversial data on the literature about the relevance of this syndrome. We propose 14 different types according to the present symptoms, and eventual associated mental pathology. In primary SD, without associated psychiatric pathology, an "exceptional" personality and, in 12% of cases, a traumatism during childhood were reported. These results may help designing a future prospective study.

  11. A Comprehensive study of a New Multipath Energy Aware Routing Protocol for Mobile Ad-hoc Networks

    OpenAIRE

    Chettibi, Saloua

    2009-01-01

    S. Chettibi, M. Benmohammed, "A comprehensive study of a new multipath energy aware routing protocol for mobile ad-hoc networks"; International Conference on Systems and Information Processing, ICSIP'09, May 02 – 04, 2009, Guelma, Algeria; Maximizing network lifetime is a very challenging issue in routing protocol design for Mobile Ad-hoc NETworks (MANETs), since mobile nodes are powered by limited-capacity batteries. Furthermore, replacing or recharging batteries is often impossible in criti...

  12. A Comparison of Oral Structure and Oral-Motor Function in Young Males with Fragile X Syndrome and Down Syndrome

    Science.gov (United States)

    Barnes, Elizabeth F.; Roberts, Joanne; Mirrett, Penny; Sideris, John; Misenheimer, Jan

    2006-01-01

    This study compared the oral structure and oral-motor skills of 59 boys with fragile X syndrome (FXS), 34 boys with Down syndrome (DS), and 36 developmentally similar typically developing (TD) boys. An adaptation of the J. Robbins and T. Klee (1987) Oral Speech Motor Protocol was administered to participants and their scores on measures of oral…

  13. Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis.

    Science.gov (United States)

    Alanazi, Adwan; Elleithy, Khaled

    2015-09-02

    Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol.

  14. Asperger syndrome related suicidal behavior: two case studies

    Directory of Open Access Journals (Sweden)

    Kocourkova J

    2013-11-01

    Full Text Available Jana Kocourkova, Iva Dudova, Jiri Koutek Department of Child Psychiatry, Charles University Second Faculty of Medicine, University Hospital Motol, Prague, Czech Republic Abstract: Asperger syndrome hinders adaptation to developmental challenges during childhood and adolescence, particularly with regard to interpersonal relationships. Individuals with Asperger syndrome display lack of empathy and limited ability to understand social and emotional exchanges with other people. Individuals with Asperger syndrome are significantly exposed to the risk of suicidal behavior, especially during adolescence. The authors describe cases of suicidal behavior in two adolescent boys with Asperger syndrome. Keywords: Asperger syndrome, suicidal behavior, adolescence

  15. Association between kyphosis and subacromial impingement syndrome: LOHAS study.

    Science.gov (United States)

    Otoshi, Kenichi; Takegami, Misa; Sekiguchi, Miho; Onishi, Yoshihiro; Yamazaki, Shin; Otani, Koji; Shishido, Hiroaki; Kikuchi, Shinichi; Konno, Shinichi

    2014-12-01

    Kyphosis is a cause of scapular dyskinesis, which can induce various shoulder disorders, including subacromial impingement syndrome (SIS). This study aimed to clarify the impact of kyphosis on SIS with use of cross-sectional data from the Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS). The study enrolled 2144 participants who were older than 40 years and participated in health checkups in 2010. Kyphosis was assessed by the wall-occiput test (WOT) for thoracic kyphosis and the rib-pelvic distance test (RPDT) for lumbar kyphosis. The associations between kyphosis, SIS, and reduction in shoulder elevation (RSE) were investigated. Age- and gender-adjusted logistic regression analysis demonstrated significant association between SIS and WOT (odds ratio, 1.65; 95% confidence interval, 1.02, 2.64; P shoulder elevation induced by the restriction of the thoracic spine extension and scapular dyskinesis. Copyright © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  16. Dissociations in mathematical knowledge: case studies in Down's syndrome and Williams syndrome.

    Science.gov (United States)

    Robinson, Sally J; Temple, Christine M

    2013-02-01

    A study is reported of mathematical vocabulary and factual mathematical knowledge in PQ, a 22 year old with Down's syndrome (DS) who has a verbal mental age (MA) of 9 years 2 months and ST, a 15 year old with Williams syndrome (WS) who has a verbal MA of 9 years 6 months, matched to typically developing controls. The number of mathematical words contained within PQ's lexical stores was significantly reduced as reflected by performance on lexical decision. PQ was also impaired at both naming from descriptions and describing mathematical words. These results contrast with normal lexical decision and item descriptions for concrete words reported recently for PQ (Robinson and Temple, 2010). PQ's recall of mathematical facts was also impaired, whilst his recall of general knowledge facts was normal. This performance in DS indicates a deficit in both lexical representation and semantic knowledge for mathematical words and mathematical facts. In contrast, ST, the teenager with WS had good accuracy on lexical decision, naming and generating definitions for mathematical words. This contrasted with the atypical performance with concrete words recently reported for ST (Robinson and Temple, 2009). Knowledge of addition facts and general knowledge facts was also unimpaired for ST, though knowledge of multiplication facts was weak. Together the cases form a double dissociation and provide support for the distinct representation of mathematical and concrete items within the lexical-semantic system during development. The dissociations between mathematical and general factual knowledge also indicate that different types of factual knowledge may be selectively impaired during development. There is further support for a modular structure within which mathematical vocabulary and mathematical knowledge have distinct representations. This supports the case for the independent representation of factual and language-based knowledge within the semantic system during development. Copyright

  17. The Metabolic Syndrome and Risk of Sudden Cardiac Death: The Atherosclerosis Risk in Communities Study.

    Science.gov (United States)

    Hess, Paul L; Al-Khalidi, Hussein R; Friedman, Daniel J; Mulder, Hillary; Kucharska-Newton, Anna; Rosamond, Wayne R; Lopes, Renato D; Gersh, Bernard J; Mark, Daniel B; Curtis, Lesley H; Post, Wendy S; Prineas, Ronald J; Sotoodehnia, Nona; Al-Khatib, Sana M

    2017-08-23

    Prior studies have demonstrated a link between the metabolic syndrome and increased risk of cardiovascular mortality. Whether the metabolic syndrome is associated with sudden cardiac death is uncertain. We characterized the relationship between sudden cardiac death and metabolic syndrome status among participants of the ARIC (Atherosclerosis Risk in Communities) Study (1987-2012) free of prevalent coronary heart disease or heart failure. Among 13 168 participants, 357 (2.7%) sudden cardiac deaths occurred during a median follow-up of 23.6 years. Participants with the metabolic syndrome (n=4444) had a higher cumulative incidence of sudden cardiac death than those without it (n=8724) (4.1% versus 2.3%, P metabolic syndrome, the metabolic syndrome was independently associated with sudden cardiac death (hazard ratio, 1.70, 95% confidence interval, 1.37-2.12, P metabolic syndrome criteria components. The risk of sudden cardiac death varied according to the number of metabolic syndrome components (hazard ratio 1.31 per additional component of the metabolic syndrome, 95% confidence interval, 1.19-1.44, P metabolic syndrome was associated with a significantly increased risk of sudden cardiac death irrespective of sex or race. The risk of sudden cardiac death was proportional to the number of metabolic syndrome components. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  18. Outcome of acute lymphoblastic leukemia in children with down syndrome-Polish pediatric leukemia and lymphoma study group report.

    Science.gov (United States)

    Zawitkowska, Joanna; Odój, Teresa; Drabko, Katarzyna; Zaucha-Prażmo, Agnieszka; Rudnicka, Julia; Romiszewski, Michał; Matysiak, Michał; Kwiecińska, Kinga; Ćwiklińska, Magdalena; Balwierz, Walentyna; Owoc-Lempach, Joanna; Derwich, Katarzyna; Wachowiak, Jacek; Niedźwiecki, Maciej; Adamkiewicz-Drożyńska, Elżbieta; Trelińska, Joanna; Młynarski, Wojciech; Kołtan, Andrzej; Wysocki, Mariusz; Tomaszewska, Renata; Szczepański, Tomasz; Płonowski, Marcin; Krawczuk-Rybak, Maryna; Ociepa, Tomasz; Urasiński, Tomasz; Mizia-Malarz, Agnieszka; Sobol-Milejska, Grażyna; Karolczyk, Grażyna; Kowalczyk, Jerzy

    2017-05-01

    Children with Down syndrome (DS) have a 20-fold increased risk of developing leukemia compared with the general population. The aim of the study was to analyze the outcome of patients diagnosed with Down syndrome and acute lymphoblastic leukemia (ALL) in Poland between the years 2003 and 2010. A total of 1848 children were diagnosed with ALL (810 females and 1038 males). Of those, 41 (2.2%) had DS. The children were classified into three risk groups: a standard-risk group-14 patients, an intermediate-risk group-24, a high-risk group-3. All patients were treated according to ALLIC 2002 protocol. The median observation time of all patients was 6.1 years, and in patients with DS 5.3 years. Five-year overall survival (OS) was the same in all patients (86% vs 86%, long-rank test, p = .9). The relapse-free survival (RFS) was calculated as 73% in patients with DS and 81% in patients without DS during a median observation time (long-rank test, p = .3). No statistically significant differences were found in the incidence of nonrelapse mortality between those two groups of patients (p = .72). The study was based on children with ALL and Down syndrome who were treated with an identical therapy schedule as ALL patients without DS, according to risk group. This fact can increase the value of the presented results.

  19. Mood and Anxiety Disorders in Chronic Fatigue Syndrome, Fibromyalgia, and Irritable Bowel Syndrome : Results From the LifeLines Cohort Study

    NARCIS (Netherlands)

    Janssens, Karin A. M.; Zijlema, Wilma L.; Joustra, Monica L.; Rosmalen, Judith G. M.

    Objective: Functional somatic syndromes (FSSs) have often been linked to psychopathology. The aim of the current study was to compare prevalence rates of psychiatric disorders among individuals with chronic fatigue syndrome (CFS), fibromyalgia (FM), and irritable bowel syndrome (IBS). Methods: This

  20. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    Directory of Open Access Journals (Sweden)

    Fayers Peter

    2010-09-01

    Full Text Available Abstract Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1 To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2 To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1 To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1 in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2 To conduct patient focus group discussions at each of these (Phase 1 to determine care received. 3 To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2. 4 To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2. 5 To undertake document

  1. Serious gaming during multidisciplinary rehabilitation for patients with complex chronic pain or fatigue complaints: study protocol for a controlled trial and process evaluation.

    Science.gov (United States)

    Vugts, Miel A P; Joosen, Margot C W; Mert, Agali; Zedlitz, Aglaia; Vrijhoef, Hubertus J M

    2017-06-08

    Many individuals suffer from chronic pain or functional somatic syndromes and face boundaries for diminishing functional limitations by means of biopsychosocial interventions. Serious gaming could complement multidisciplinary interventions through enjoyment and independent accessibility. A study protocol is presented for studying whether, how, for which patients and under what circumstances, serious gaming improves patient health outcomes during regular multidisciplinary rehabilitation. A mixed-methods design is described that prioritises a two-armed naturalistic quasi-experiment. An experimental group is composed of patients who follow serious gaming during an outpatient multidisciplinary programme at two sites of a Dutch rehabilitation centre. Control group patients follow the same programme without serious gaming in two similar sites. Multivariate mixed-modelling analysis is planned for assessing how much variance in 250 patient records of routinely monitored pain intensity, pain coping and cognition, fatigue and psychopathology outcomes is attributable to serious gaming. Embedded qualitative methods include unobtrusive collection and analyses of stakeholder focus group interviews, participant feedback and semistructured patient interviews. Process analyses are carried out by a systematic approach of mixing qualitative and quantitative methods at various stages of the research. The Ethics Committee of the Tilburg School of Social and Behavioural Sciences approved the research after reviewing the protocol for the protection of patients' interests in conformity to the letter and rationale of the applicable laws and research practice (EC 2016.25t). Findings will be presented in research articles and international scientific conferences. A prospective research protocol for the naturalistic quasi-experimental outcome evaluation was entered in the Dutch trial register (registration number: NTR6020; Pre-results). © Article author(s) (or their employer(s) unless

  2. Prevalence of metabolic syndrome in Central America: a cross-sectional population-based study

    Directory of Open Access Journals (Sweden)

    Roy A. Wong-McClure

    2015-09-01

    Full Text Available OBJECTIVE: To report the prevalence of metabolic syndrome (MetS as found by the Central American Diabetes Initiative (CAMDI study for five major Central American populations: Belize (national; Costa Rica (San José; Guatemala (Guatemala City; Honduras (Tegucigalpa; and Nicaragua (Managua. METHODS: Study data on 6 185 adults aged 20 years or older with anthropometric and laboratory determination of MetS from population-based surveys were analyzed. Overall, the survey response rate was 82.0%. MetS prevalence was determined according to criteria from the Adult Treatment Panel III of the National Cholesterol Education Program. The study's protocol was reviewed and approved by the bioethical committee of each country studied. RESULTS: The overall standardized prevalence of MetS in the Central American region was 30.3% (95% confidence interval (CI: 27.1-33.4. There was wide variability by gender and work conditions, with higher prevalence among females and unpaid workers. The standardized percentage of the population free of any component of MetS was lowest in Costa Rica (9.0%; CI: 6.5-11.4 and highest in Honduras (21.1%; CI: 16.4-25.9. CONCLUSIONS: Overall prevalence of MetS in Central America is high. Strengthening surveillance of chronic diseases and establishing effective programs for preventing cardiovascular diseases might reduce the risk of MetS in Central America.

  3. Frey's syndrome analysis with biosensor. A preliminary study.

    Science.gov (United States)

    Laccourreye, O; Bernard, D; de Lacharriere, O; Bazin, R; Brasnu, D

    1993-09-01

    Objective quantification of Frey's syndrome (gustatory sweating), following total parotidectomy. A biosensoring method of enzymatic electrodes enabling the detection of L-lactate on intact skin with the use of a skin extraction device and enzymatic electrodes is presented and analyzed. A criterion standard study. This prospective trial was undertaken at our research laboratory (University of Paris [France]). Parotidectomy was performed in our department, which is a tertiary care center for parotid gland pathology. Twenty-eight patients with gustatory sweating following total parotidectomy and nine control patients not operated on were asked to take part in this prospective study. Gustatory sweating was assessed in all patients using a clinical scale, the Minor starch iodine test, and the L-lactate biosensoring method. Instrumentation and assay procedure for the L-lactate biosensoring method are detailed. Statistical analysis of data was performed using the Kruskal-Wallis H Test and the Mann-Whitney U Test. Results demonstrate that this method enables objective measurement of the L-lactate on skin without the need for chemical reagents, continuous nondestructive analysis in real time, and physiological dynamic monitoring of the L-lactate rate of production after stimulus. Data achieved strongly suggested that the aberrant regeneration theory is the main clue to Frey's syndrome pathogenesis. This safe, reliable, noninvasive, objective, and highly sensitive method provides an investigative tool for clinicians as well as physiologists involved with patients presenting gustatory sweating following parotid gland surgery.

  4. Study of Testicular Structure in Fetuses with Prune Belly Syndrome.

    Science.gov (United States)

    Favorito, Luciano A; Costa, Suelen F; Costa, Waldemar S; Vieiralves, Rodrigo; Bernardo, Fabio O; Sampaio, Francisco J B

    2017-01-01

    To compare the structure of the testis in fetuses with prune belly syndrome (PBS) to normal controls. We studied 6 testes obtained from 3 fetuses with PBS and 14 testes from 7 male fetuses. The testicular specimens were cut into 5- μ m thick sections and stained with hematoxylin and eosin (HE), to observe the seminiferous tubules; Weigert's solution to observe elastic fibers; and picrosirius red to observe collagen. The images were captured with an Olympus BX51 microscope and Olympus DP70 camera. The stereological analysis was done with the Image Pro and Image J programs. Means were statistically compared using the Mann-Whitney U test ( p < 0.005). Quantitative analysis documented no differences ( p = 0.4) in number of seminiferous tubules (ST) in PBS testes (mean = 8.87%, SD = 1.59), when compared to the control (mean = 11.4%, SD = 2.99) and no differences ( p = 0.8) in diameter of ST in PBS testes (mean = 52.85  μ m, SD = 1.58) when compared to the control group (mean = 53.17  μ m, SD = 1.55), but we did observe a lower number ( p = 0.0002) of Leydig cells in the PBS testes (mean = 67.03% and SD = 3.697) when compared to the control group (mean = 90.1% and SD = 2.986). Our study showed a lower concentration of Leydig cells in the triad syndrome fetuses.

  5. Sleep disturbances in Angelman syndrome: a questionnaire study.

    Science.gov (United States)

    Bruni, Oliviero; Ferri, Raffaele; D'Agostino, Gaetana; Miano, Silvia; Roccella, Michele; Elia, Maurizio

    2004-06-01

    Only few studies are available on sleep disorders in Angelman syndrome (AS), a neurodevelopmental disorder with several behavior disturbances. The aim of this study was to determine the prevalence of sleep disorders in a relatively large group of AS subjects, compared to that of age-matched controls. Forty-nine consecutive parents of patients with AS (26 males and 23 females aged 2.3-26.2 years) were interviewed and filled out a comprehensive sleep questionnaire. Based on their genetic etiology, four groups were defined: deletion of chromosome 15q11-13 (25 subjects); methylation imprinting mutation (six subjects), UBE3A mutations (seven subjects) and paternal uniparental disomy (five subjects). In the remaining cases genetic testings were negative. A significantly high frequency of disorders of initiating and maintaining sleep, prolonged sleep latency, prolonged wakefulness after sleep onset, high number of night awakenings and reduced total sleep time were found in our AS patients, as compared to age-matched controls. We also found other types of sleep disorders, never reported before, such as enuresis, bruxism, sleep terrors, somnambulism, nocturnal hyperkinesia, and snoring. No differences were found between the four genetic aetiology groups. Moreover, we did not find important improvement of sleep disturbances from pre-pubertal to post-pubertal ages. Our data confirm the significant presence of sleep/wake rhythms fragmentation, peculiar of AS, and also demonstrate the presence of several other types of sleep disturbances in this syndrome.

  6. Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention.

    Science.gov (United States)

    Farquharson, Barbara; Johnston, Marie; Smith, Karen; Williams, Brian; Treweek, Shaun; Dombrowski, Stephan U; Dougall, Nadine; Abhyankar, Purva; Grindle, Mark

    2017-05-01

    To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text + visual and text-only) with usual care. Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for acute coronary syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions. A three-arm web-based, parallel randomized controlled trial of a theory-based intervention. The intervention comprises 12 behaviour change techniques systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n = 177 participants who have experienced acute coronary syndrome in the previous 6 months from a National Health Service Hospital. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care, ii) usual care plus text-only behaviour change technique-based intervention or iii) usual care plus text + visual behaviour change technique-based intervention. The primary outcome will be the change in intention to phone an ambulance immediately with symptoms of acute coronary syndrome ≥15-minute duration, assessed using two randomized series of eight scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care). Funding granted January 2014. Positive results changing intentions would lead to a randomized controlled trial of the behaviour change intervention in clinical practice, assessing patient delay in the event of actual symptoms. Registered at ClinicalTrials.gov: NCT02820103. © 2016 John Wiley & Sons Ltd.

  7. A Study on the Distributed Antenna Based Heterogeneous Cognitive Wireless Network Synchronous MAC Protocol

    Directory of Open Access Journals (Sweden)

    Lian-Fen Huang

    2015-01-01

    Full Text Available This paper introduces distributed antennas into a cognitive radio network and presents a heterogeneous network. The best contribution of this paper is that it designs a synchronous cognitive MAC protocol (DAHCWNS-MAC protocol: distributed antenna based heterogeneous cognitive wireless network synchronous MAC protocol. The novel protocol aims at combining the advantages of cognitive radio and distributed antennas to fully utilize the licensed spectrum, broaden the communication range, and improve throughput. This paper carries out the mathematical modeling and performance simulation to demonstrate its superiority in improving the network throughput at the cost of increasing antenna hardware costs.

  8. [Evaluation of ear acupressure on painful shoulder syndrome: case study].

    Science.gov (United States)

    Zanelatto, Ana Paula

    2013-01-01

    The Painful Shoulder Syndrome (PSS) is defined as pain and functional limitation resulting from impairment of static and dynamic structures of the shoulder, such as ligaments, capsule and muscles. It is one of the most common and disabling of the musculoskeletal system in the general population with prevalence estimated between 15-25%. This study aimed to evaluate the results of auricular acupressure when used as therapy in the treatment of chronic pain secondary to SOD, and the analgesic effect and therapeutic satisfactory and the estimated time of treatment. To obtain the objective was to perform a case study was to intervene with auricular acupressure beads and crystals as an indicator of the outcome questionnaire Penn Shoulder Score (PSS - Brazil). Data were analyzed qualitatively and quantitatively. We conclude that auriculotherapy is an important therapeutic technique, because the study showed an improvement in the total score of the PSS - Brazil at 34.3%.

  9. Sexually transmitted disease syndromic case management through public sector facilities: development and assessment study in Punjab Pakistan.

    Science.gov (United States)

    Khan, Muhammad Amir; Javed, Wajiha; Ahmed, Maqsood; Walley, John; Munir, Muhammad Arif

    2014-01-01

    Sexually transmitted infections (STIs) are a priority health problem. We proposed a prospective study in two districts of Punjab, using an intervention package, which included guidelines and protocols on syndrome-based management of STIs, adapted in light of technical guidelines from the National AIDS Control Program and the World Health Organization. The aim of this study was to assess the operational effectiveness of STI case management guidelines and to assess factors that determine the adherence to guidelines for management of STIs at public health facilities in Pakistan. A prospective study lasting 18 months (January 2008 to June 2009), which reviewed early implementation experiences of updated case management guidelines for delivery of syndrome-based STI/reproductive tract infection care, through public-sector health care facilities. The project was implemented in two districts of Punjab, Sargodha and Jhang. A Cox regression model with stratification was done. The prevalence of STI was 26 per 100,000 patients. In women, the reported symptoms were 80% vaginal discharge and 12% abdominal pain. Forty-four percent of men had a genital ulcer and 29% of men had genital discharge. Age of participants ranged from 13 to 60 years. The study comprised 28.6% men and 71.4% women. The majority of the population attending these clinics was from rural areas (70%). The variables independently associated with adherence to guidelines were availability of male paramedic, age of patient, and type of diagnosis made. There was an important interaction (effect modification) present between the area of health facility and patient sex. Screening, diagnosis, and treatment costs for many STIs are expensive and thus an easier, low-cost, syndrome-based public health strategy is the adoption of the proposed STI syndrome case management guidelines. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

  10. Diabetes mellitus and optic atrophy: study of the Wolfram syndrome

    Science.gov (United States)

    Rivas-Gómez, Bernardette; Reza-Albarrán, Alfredo Adolfo

    2017-01-01

    Wolfram syndrome (WS), also known by the acronym DIDMOAD, is a rare and progresive hereditary disease of autosomal recessive inheritance which minimum ascertainment diagnostic criteria are the occurrence together of diabetes mellitus and optic atrophy before 15 years of age. To describe the clinical, biochemical and molecular profile of WS in a tertiary care hospital in Mexico. We reviewed patients records who fulfill the minimum ascertainment diagnostic criteria of WS presenting between January 1987 and May 2015 in a tertiary care hospital in Mexico. Five patients fulfill the inclusion criteria (three male and two female). Diabetes mellitus was the first manifestation of the syndrome in all of them, with a mean age at diagnosis of 5.8 ± 2.71 years, while the WS diagnosis was established at a mean age of 15.8 ± 8.37 years. All the patients had optic atrophy and two of them presented with the complete DIDMOAD spectrum. We found new associations with autoimmune hepatitis and testicular cancer. This study shows the variability of clinical presentation of WS, as well as two new associations. Copyright: © 2017 SecretarÍa de Salud

  11. Developing protocols for geochemical baseline studies: An example from the Coles Hill uranium deposit, Virginia, USA

    International Nuclear Information System (INIS)

    Levitan, Denise M.; Schreiber, Madeline E.; Seal, Robert R.; Bodnar, Robert J.; Aylor, Joseph G.

    2014-01-01

    Highlights: • We outline protocols for baseline geochemical surveys of stream sediments and water. • Regression on order statistics was used to handle non-detect data. • U concentrations in stream water near this unmined ore were below regulatory standards. • Concentrations of major and trace elements were correlated with stream discharge. • Methods can be applied to other extraction activities, including hydraulic fracturing. - Abstract: In this study, we determined baseline geochemical conditions in stream sediments and surface waters surrounding an undeveloped uranium deposit. Emphasis was placed on study design, including site selection to encompass geological variability and temporal sampling to encompass hydrological and climatic variability, in addition to statistical methods for baseline data analysis. The concentrations of most elements in stream sediments were above analytical detection limits, making them amenable to standard statistical analysis. In contrast, some trace elements in surface water had concentrations that were below the respective detection limits, making statistical analysis more challenging. We describe and compare statistical methods appropriate for concentrations that are below detection limits (non-detect data) and conclude that regression on order statistics provided the most rigorous analysis of our results, particularly for trace elements. Elevated concentrations of U and deposit-associated elements (e.g. Ba, Pb, and V) were observed in stream sediments and surface waters downstream of the deposit, but concentrations were below regulatory guidelines for the protection of aquatic ecosystems and for drinking water. Analysis of temporal trends indicated that concentrations of major and trace elements were most strongly related to stream discharge. These findings highlight the need for sampling protocols that will identify and evaluate the temporal and spatial variations in a thorough baseline study

  12. Lasting improvements in left spatial neglect following a protocol combining neck-muscle vibration and voluntary arm movements: a case-study.

    Science.gov (United States)

    Ceyte, Hadrien; Beis, Jean-Marie; Simon, Mathilde; Rémy, Ariane; Anxionnat, René; Paysant, Jean; Caudron, Sébastien

    2018-01-22

    Beyond promising experimental results of sensory passive stimulations in spatial cognition disorders, some questions still remain regarding interests of these stimulations during the daily activities in neglect. The aim of this case-study was to evaluate the effects of a protocol combining left neck-muscle vibration with daily simple movements, like arm pointing movements, on perceptivo-locomotor deficits in a left spatial neglect patient. Two neuropsychological tests, one subjective straight-ahead pointing (SSA) test and one wheelchair navigation test were carried out before the combination protocol, immediately after, 1 h later, and 24 h later. The results showed a reduction of neglect spatial bias following the protocol lasted at least 24 h in all the tests (except for the SSA test due to the unavailability of the pointing device). The range of improvements in the symptoms of spatial neglect suggests that this therapeutic intervention based on the combining neck-muscle vibration to voluntary arm movements could be a useful treatment for this condition. One of future investigation axes should be the development of a vibratory tool in order to facilitate the combining this proprioceptive stimulation to daily activities. Implications for rehabilitation Spatial neglect is a perplexing neuropsychological syndrome, affecting different domains of spatial cognition and impacting also the functional domain. The treatments based on neck-muscle vibration are simple to use, non-invasive and requires none active participation of patient. A therapeutic intervention based on the combining left neck-muscle vibration and voluntary arm movements in a left-spatial-neglect show a lasting reduction of symptoms especially in daily activities. The combination of treatments based on the Bottom-Up approach opens innovative perspectives in rehabilitation.

  13. Back muscle strength and fatigue in healthy and chronic low back pain subjects: a comparative study of 3 assessment protocols.

    Science.gov (United States)

    da Silva, Rubens A; Arsenault, A Bertrand; Gravel, Denis; Larivière, Christian; de Oliveira, Eros

    2005-04-01

    To compare the sensitivity of 3 different back test protocols in measuring differences in strength and fatigue between subjects with and without chronic low back pain (CLBP). Descriptive study using a repeated-measures design. A research laboratory within a rehabilitation center. Eighteen healthy subjects and 13 subjects with CLBP were assessed in a single session to compare the 3 protocols. The protocols were an upright position test (UPP), a semicrouched lifting test (LIF), and the Sorensen fatigue test. Not applicable. Moments of force and surface electromyography were recorded bilaterally from 4 homologous back muscles while the subjects performed static trunk extension efforts for each protocol. Fatigue was quantified by the slopes of the linear regression of electromyography time-series. The back muscle fatigue and strength scores did not differ significantly for the 2 subject groups for any of the 3 protocols. The electromyography fatigue indices revealed that the Sorensen fatigue test and UPP produced more fatigue in the back muscles than the LIF. It was impossible to specify which protocol is more sensitive to low back status because no between-group difference was observed for any of the 3 tests.

  14. National validation study of a swab protocol for the recovery of Bacillus anthracis spores from surfaces.

    Science.gov (United States)

    Hodges, Lisa R; Rose, Laura J; O'Connell, Heather; Arduino, Matthew J

    2010-05-01

    Twelve Laboratory Response Network (LRN) affiliated laboratories participated in a validation study of a macrofoam swab protocol for the recovery, detection, and quantification of viable B. anthracis (BA) Sterne spores from steel surfaces. CDC personnel inoculated steel coupons (26cm(2)) with 1-4 log(10) BA spores and recovered them by sampling with pre-moistened macrofoam swabs. Phase 1 (P1) of the study evaluated swabs containing BA only, while dust and background organisms were added to swabs in Phase 2 (P2) to mimic environmental conditions. Laboratories processed swabs and enumerated spores by culturing eluted swab suspensions and counting colonies with morphology consistent with BA. Processed swabs were placed in enrichment broth, incubated 24h, and cultured by streaking for isolation. Real-time PCR was performed on selected colonies from P2 samples to confirm the identity of BA. Mean percent recovery (%R) of spores from the surface ranged from 15.8 to 31.0% (P1) and from 27.9 to 55.0% (P2). The highest mean percent recovery was 31.0% (sd 10.9%) for P1 (4 log(10) inoculum) and 55.0% (sd 27.6%) for P2 (1 log(10) inoculum). The overall %R was higher for P2 (44.6%) than P1 (24.1%), but the overall reproducibility (between-lab variability) was lower in P2 than in P1 (25.0 vs 16.5%CV, respectively). The overall precision (within-lab variability) was close to identical for P1 and P2 (44.0 and 44.1, respectively), but varied greatly between inoculum levels. The protocol demonstrated linearity in %R over the three inoculum levels and is able to detect between 26 and 5x10(6)spores/26cm(2). Sensitivity as determined by culture was >98.3% for both phases and all inocula, suggesting that the culture method maintains sensitivity in the presence of contaminants. The enrichment broth method alone was less sensitive for sampled swabs (66.4%) during P2, suggesting that the presence of background organisms inhibited growth or isolation of BA from the broth. The addition of

  15. Nationwide cross-sectional survey of schistosomiasis and soil-transmitted helminthiasis in Sudan: study protocol.

    Science.gov (United States)

    Cha, Seungman; Hong, Sung-Tae; Lee, Young-Ha; Lee, Keon Hoon; Cho, Dae Seong; Lee, Jinmoo; Chai, Jong-Yil; Elhag, Mousab Siddig; Khaled, Soheir Gabralla Ahmad; Elnimeiri, Mustafa Khidir Mustafa; Siddig, Nahid Abdelgadeir Ali; Abdelrazig, Hana; Awadelkareem, Sarah; Elshafie, Azza Tag Eldin; Ismail, Hassan Ahmed Hassan Ahmed; Amin, Mutamad

    2017-09-12

    Schistosomiasis and soil-transmitted helminthiasis (STHs) are target neglected tropical diseases (NTDs) of preventive chemotherapy, but the control and elimination of these diseases have been impeded due to resource constraints. Few reports have described study protocol to draw on when conducting a nationwide survey. We present a detailed methodological description of the integrated mapping of schistosomiasis and STHs on the basis of our experiences, hoping that this protocol can be applied to future surveys in similar settings. In addition to determining the ecological zones requiring mass drug administration interventions, we aim to provide precise estimates of the prevalence of these diseases. A school-based cross-sectional design will be applied for the nationwide survey across Sudan. The survey is designed to cover all districts in every state. We have divided each district into 3 different ecological zones depending on proximity to bodies of water. We will employ a probability-proportional-to-size sampling method for schools and systematic sampling for student selection to provide adequate data regarding the prevalence for schistosomiasis and STHs in Sudan at the state level. A total of 108,660 students will be selected from 1811 schools across Sudan. After the survey is completed, 391 ecological zones will be mapped out. To carry out the survey, 655 staff members were recruited. The feces and urine samples are microscopically examined by the Kato-Katz method and the sediment smears for helminth eggs respectively. For quality control, a minimum of 10% of the slides will be rechecked by the federal supervisors in each state and also 5% of the smears are validated again within one day by independent supervisors. This nationwide mapping is expected to generate important epidemiological information and indicators about schistosomiasis and STHs that will be useful for monitoring and evaluating the control program. The mapping data will also be used for overviewing

  16. Impact of alprazolam in allostatic load and neurocognition of patients with anxiety disorders and chronic stress (GEMA): observational study protocol

    Science.gov (United States)

    Soria, Carlos A; Remedi, Carolina; Núñez, Daniel A; D'Alessio, Luciana; Roldán, Emilio J A

    2015-01-01

    Introduction The allostatic load model explains the additive effects of multiple biological processes that accelerate pathophysiology related to stress, particularly in the central nervous system. Stress-related mental conditions such as anxiety disorders and neuroticism (a well-known stress vulnerability factor), have been linked to disturbances of hypothalamo–pituitary–adrenal with cognitive implications. Nevertheless, there are controversial results in the literature and there is a need to determine the impact of the psychopharmacological treatment on allostatic load parameters and in cognitive functions. Gador study of Estres Modulation by Alprazolam, aims to determine the impact of medication on neurobiochemical variables related to chronic stress, metabolic syndrome, neurocognition and quality of life in patients with anxiety, allostatic load and neuroticism. Methods/analysis In this observational prospective phase IV study, highly sympthomatic patients with anxiety disorders (six or more points in the Hamilton-A scale), neuroticism (more than 18 points in the Neo five personality factor inventory (NEO-FFI) scale), an allostatic load (three positive clinical or biochemical items at Crimmins and Seeman criteria) will be included. Clinical variables of anxiety, neuroticism, allostatic load, neurobiochemical studies, neurocognition and quality of life will be determined prior and periodically (1, 2, 4, 8, and 12 weeks) after treatment (on demand of alprazolam from 0.75 mg/day to 3.0 mg/day). A sample of n=55/182 patients will be considered enough to detect variables higher than 25% (pretreatment vs post-treatment or significant correlations) with a 1-ß power of 0–80. t Test and/or non-parametric test, and Pearson's test for correlation analysis will be determined. Ethics and dissemination This study protocol was approved by an Independent Ethics Committee of FEFyM (Foundation for Pharmacological Studies and Drugs, Buenos Aires) and by regulatory

  17. Impact of alprazolam in allostatic load and neurocognition of patients with anxiety disorders and chronic stress (GEMA): observational study protocol.

    Science.gov (United States)

    Soria, Carlos A; Remedi, Carolina; Núñez, Daniel A; D'Alessio, Luciana; Roldán, Emilio J A

    2015-07-14

    The allostatic load model explains the additive effects of multiple biological processes that accelerate pathophysiology related to stress, particularly in the central nervous system. Stress-related mental conditions such as anxiety disorders and neuroticism (a well-known stress vulnerability factor), have been linked to disturbances of hypothalamo-pituitary-adrenal with cognitive implications. Nevertheless, there are controversial results in the literature and there is a need to determine the impact of the psychopharmacological treatment on allostatic load parameters and in cognitive functions. Gador study of Estres Modulation by Alprazolam, aims to determine the impact of medication on neurobiochemical variables related to chronic stress, metabolic syndrome, neurocognition and quality of life in patients with anxiety, allostatic load and neuroticism. In this observational prospective phase IV study, highly sympthomatic patients with anxiety disorders (six or more points in the Hamilton-A scale), neuroticism (more than 18 points in the Neo five personality factor inventory (NEO-FFI) scale), an allostatic load (three positive clinical or biochemical items at Crimmins and Seeman criteria) will be included. Clinical variables of anxiety, neuroticism, allostatic load, neurobiochemical studies, neurocognition and quality of life will be determined prior and periodically (1, 2, 4, 8, and 12 weeks) after treatment (on demand of alprazolam from 0.75 mg/day to 3.0 mg/day). A sample of n=55/182 patients will be considered enough to detect variables higher than 25% (pretreatment vs post-treatment or significant correlations) with a 1-ß power of 0-80. t Test and/or non-parametric test, and Pearson's test for correlation analysis will be determined. This study protocol was approved by an Independent Ethics Committee of FEFyM (Foundation for Pharmacological Studies and Drugs, Buenos Aires) and by regulatory authorities of Argentina (ANMAT, Dossier # 61 409-8 of 20

  18. Recall of intensive care unit stay in patients managed with a sedation protocol or a sedation protocol with daily sedative interruption: a pilot study.

    Science.gov (United States)

    Ethier, Cheryl; Burry, Lisa; Martinez-Motta, Carlos; Tirgari, Sam; Jiang, Depeng; McDonald, Ellen; Granton, John; Cook, Deborah; Mehta, Sangeeta

    2011-04-01

    Analgesics and sedatives are integral for the relief of pain and anxiety in critically ill patients. However, these agents may contribute to amnesia for intensive care unit (ICU) events; which has been associated with development of posttraumatic stress disorder. Drug administration strategies that minimize sedative use have been associated with less amnesia. The objective of this pilot study was to evaluate recall of ICU stay in patients managed with 2 sedation strategies: a sedation protocol or a combination of sedation protocol and daily sedative/analgesic interruption. A questionnaire was administered on day 3 following ICU discharge to evaluate patients' recollections of pain, anxiety, fear, and sleep, as well as memories for specific ICU procedures. Participants were ICU survivors who had been enrolled in SLEAP - a randomized pilot trial comparing two sedation strategies, at 3 university-affiliated medical/surgical ICUs. Twenty-one patients who regained orientation within 72 hours of ICU discharge completed the questionnaire. More than 50% of patients recalled experiencing pain, anxiety, and fear to a moderate or extreme extent; and 57% reported inadequate sleep while in the ICU. Of the 21 patients, 48%, 33%, and 29% had no memories of endotracheal tube suctioning, being on a "breathing machine," and being bathed, respectively. A notable percentage of patients discharged from the ICU report moderate to extreme pain, anxiety, and fear, and inability to sleep during their ICU stay; and 29% to 48% have no recall of specific ICU events. Copyright © 2011 Elsevier Inc. All rights reserved.

  19. Optimal protocol for teleconsultation with a cellular phone for dentoalveolar trauma: an in-vitro study

    International Nuclear Information System (INIS)

    Park, Won Se; Lee, Hae Na; Jeong, Jin Sun; Kwon, Jung Hoon; Lee, Grace H; Kim, Kee Dong

    2012-01-01

    Dental trauma is frequently unpredictable. The initial assessment and urgent treatment are essential for dentists to save the patient's teeth. Mobile-phone-assisted teleconsultation and telediagnosis for dental trauma could be an aid when a dentist is not available. In the present in-vitro study, we evaluated the success rate and time to transfer images under various conditions. We analyzed the image quality of cameras built into mobile phones based on their resolution, autofocus, white-balance, and anti-movement functions. The image quality of most built-in cameras was acceptable to perform the initial assessment, with the autofocus function being essential to obtain high-quality images. The transmission failure rate increased markedly when the image size exceeded 500 kB and the additional text messaging did not improve the success rate or the transmission time. Our optimal protocol could be useful for emergency programs running on the mobile phones.

  20. Imaging findings in cardiac masses (Part I): study protocol and benign tumors.

    Science.gov (United States)

    Díaz Angulo, C; Méndez Díaz, C; Rodríguez García, E; Soler Fernández, R; Rois Siso, A; Marini Díaz, M

    2015-01-01

    Cardiac masses represent a diagnostic challenge because decisions about treatment are based on imaging techniques. Echocardiography, magnetic resonance (MR) and computed tomography (CT) are fundamental for the detection, characterization, and staging of cardiac masses as well as for planning their treatment. Most primary cardiac tumors are benign; myxomas, papillary fibroelastomas, and lipomas are the most common. The location of the tumors and its characteristics on CT and MR orient the etiologic diagnosis in most cases. This article describes the protocols for CT and MR studies of cardiac masses as well as the morphologic findings, predominant locations, and most useful characteristics for characterizing benign cardiac masses and establishing the differential diagnosis with malignant cardiac tumors and non-neoplastic pseudotumors. Copyright © 2014 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

  1. Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism

    DEFF Research Database (Denmark)

    Stott, David J.; Gussekloo, Jacobijn; Kearney, Patricia M.

    2017-01-01

    BACKGROUND: Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large...... in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.......0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic...

  2. Optimal protocol for teleconsultation with a cellular phone for dentoalveolar trauma: an in-vitro study

    Energy Technology Data Exchange (ETDEWEB)

    Park, Won Se; Lee, Hae Na; Jeong, Jin Sun; Kwon, Jung Hoon; Lee, Grace H; Kim, Kee Dong [College of Dentistry, Yonsei University, Seoul (Korea, Republic of)

    2012-06-15

    Dental trauma is frequently unpredictable. The initial assessment and urgent treatment are essential for dentists to save the patient's teeth. Mobile-phone-assisted teleconsultation and telediagnosis for dental trauma could be an aid when a dentist is not available. In the present in-vitro study, we evaluated the success rate and time to transfer images under various conditions. We analyzed the image quality of cameras built into mobile phones based on their resolution, autofocus, white-balance, and anti-movement functions. The image quality of most built-in cameras was acceptable to perform the initial assessment, with the autofocus function being essential to obtain high-quality images. The transmission failure rate increased markedly when the image size exceeded 500 kB and the additional text messaging did not improve the success rate or the transmission time. Our optimal protocol could be useful for emergency programs running on the mobile phones.

  3. A prospective study of total sleep duration and incident metabolic syndrome: the ARIRANG study.

    Science.gov (United States)

    Kim, Jang-Young; Yadav, Dhananjay; Ahn, Song Vogue; Koh, Sang-Baek; Park, Jong Taek; Yoon, Junghan; Yoo, Byung-Su; Lee, Seung-Hwan

    2015-12-01

    Chronic sleep deprivation is increasingly common in industrialized societies. Recent data have revealed that chronic sleep deprivation is associated with negative health outcome. While prospective studies lack the predictive value of sleep duration to identify individuals at high risk of new-onset metabolic syndrome, total sleep duration may play a role in the development of metabolic abnormalities. This study investigates the association between total sleep duration and the incidence of metabolic syndrome in a population-based longitudinal study. At baseline, a prospective cohort study was conducted with 2579 adults without metabolic syndrome aged between 40 and 70 years. Based on a self-reported questionnaire, the participants in this study were investigated between 2005-2008 (baseline) and 2008-2011 (follow-up) and were categorized according to their total sleep duration (definition. During an average of 2.6 years of follow-up, 558 (21.6%) subjects developed metabolic syndrome. In multivariable adjusted models, the odds ratio (95% confidence interval (CI)) for incident metabolic syndrome comparing the 6 to 7.9 h to the sleep duration was 1.41 (1.06-1.88). The corresponding odds ratios (95% CI) for high waist circumference, low high-density lipoprotein (HDL) cholesterol, high triglycerides, high blood pressure, and high blood glucose were 1.30 (0.98-1.69), 0.75 (0.56-0.97), 0.82 (0.60-1.11), 1.56 (1.19-2.03), and 1.31 (0.96-1.79), respectively. Short sleep duration is an independent risk factor for incident metabolic syndrome in a population-based longitudinal study. Copyright © 2015 Elsevier B.V. All rights reserved.

  4. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  5. [An integrative and transdiagnostic relaxation protocol for anxious patients. Results of a pilot study].

    Science.gov (United States)

    Servant, D; Germe, A; Autuori, M; De Almeida, F; Hay, M; Douilliez, C; Vaiva, G

    2014-12-01

    The literature data show that relaxation practice is effective in reducing anxiety symptoms. Different techniques such as progressive muscular relaxation, autogenic training, applied relaxation and meditation have been evaluated independently for anxiety disorders. The question is to know whether the combination of various techniques may be of interest in the transdiagnostic treatment of anxiety disorders. The present study assessed the short-term efficacy of a 10-week integrative and transdiagnostic relaxation program for anxiety disorders in outpatients of an anxiety disorders unit. The diagnoses were made according to the Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) and completed with an assessment of anxiety and depressive symptoms using: the State Trait Anxiety Inventory (STAI-Y, -S and -T), the Penn State Worry Questionnaire (PSWQ) and the Beck Depression Inventory (BDI-II). Four techniques were integrated into the structured 10-week protocol: breathing control, muscular relaxation, meditation and mental visualization. Twenty-eight patients (12 men and 16 women), mean age (S.D.)=38.82 years (11.57), were included in the study. All the included patients fulfilled the DSM-IV criteria for a current diagnosis of Generalized Anxiety Disorder (n=13) or Panic Disorder (n=15) with or without agoraphobia. At the end of the 10 sessions, we found a significant reduction in mean scores (S.D.) on the STAI-T from 53.179 (6.037) to 49.821 (8.028) (Panxiety, depression and worry. The integrative and transdiagnostic relaxation program could represent an accessible and effective treatment to reduce anxious and depressive symptoms in various anxiety disorders. Future research should address the development of controlled trials assessing the impact of the different dimensions of anxiety and the long-term effects of this protocol. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  6. Comparative study of 2 oral care protocols in intensive care units.

    Science.gov (United States)

    Ory, Jérôme; Raybaud, Evelyne; Chabanne, Russell; Cosserant, Bernard; Faure, Jean Sébastien; Guérin, Renaud; Calvet, Laure; Pereira, Bruno; Mourgues, Charline; Guelon, Dominique; Traore, Ousmane

    2017-03-01

    The quality of oral care is important in limiting the emergence of ventilator-associated pneumonia (VAP) in intubated patients. Our main objective was to measure the quality improvement in oral care following the implementation of a new oral care protocol. We also monitored VAP rates. This was a cohort study of patients in 5 adult ICUs covering different specialties. During period 1, caregivers used a foam stick for oral care and during period 2 a stick and tooth brushing with aspiration. Oral chlorhexidine was used during both periods. The caregivers rated improvement in oral health on the basis of 4 criteria (tongue, mucous membranes, gingivae, and teeth). Caregiver satisfaction was also assessed. The incidence of VAP was monitored. A total of 2,030 intubated patients admitted to intensive care units benefited from oral care. The patient populations during the 2 periods were similar with regard to demographic data and VAP potential risk factors. Oral health was significantly better from the third day of oral care in period 2 onward (period 1, 6.4 ± 2.1; period 2, 5.6 ± 1.8; P = .043). Caregivers found the period 2 protocol easier to implement and more effective. VAP rates decreased significantly between the 2 periods (period 1, 12.8%; period 2, 8.5%; P = .002). Our study showed that the implementation of a simple strategy improved the quality of oral care of patients in intensive care units, and decreased VAP rates. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  7. Parental Alienation Syndrome in Italian legal judgments: an exploratory study.

    Science.gov (United States)

    Lavadera, Anna Lubrano; Ferracuti, Stefano; Togliatti, Marisa Malagoli

    2012-01-01

    The present study highlights the characteristics of separated families in Italy for whom Parental Alienation Syndrome (PAS) has been diagnosed during court custody evaluations. The study analyzed the psychological reports of 12 court-appointed expert evaluations of families for whom PAS had been diagnosed. Twelve evaluations that did not receive the PAS diagnosis served as a control group. A specific coding system was used for data analysis. The results indicated that the alienating parents were always the parents who had custody of the children. Children who were diagnosed with PAS were predominantly the only child in the family, had identity problems and manifested manipulative behavior. The consultant in these cases suggested individual psychotherapy for the children and recommended foster care to the Social Services agency. Copyright © 2012 Elsevier Ltd. All rights reserved.

  8. Asperger Syndrome and Schizophrenia: A Comparative Neuropsychological Study.

    Science.gov (United States)

    Marinopoulou, Maria; Lugnegård, Tove; Hallerbäck, Maria Unenge; Gillberg, Christopher; Billstedt, Eva

    2016-07-01

    There has been an increasing interest in possible connections between autism spectrum disorder (ASD) and schizophrenia in the last decade. Neuropsychological comparison studies have, however, been few. The present study examined similarities and differences in intellectual and executive functioning between adults with Asperger syndrome (AS) and adults with schizophrenic psychosis (SP). A group with AS and a group with SP were assessed neuropsychologically with WAIS-III and D-KEFS. Similarities were found between groups, as displayed by an uneven cognitive profile, limitations in working memory, processing speed and some aspects of executive functioning. Full Scale IQ was higher in the AS group. These results add to the current research illuminating similarities and differences between ASD and schizophrenia on a cognitive level.

  9. Concrete release protocol case studies for decommissioning work at the Idaho National Engineering and Environmental Laboratory

    International Nuclear Information System (INIS)

    Kamboj, S.; Arnish, J.; Chen, S-Y; Parker, F. L.; Phillips, A. M.; Tripp, J. L.; Meservey, R. H.

    2000-01-01

    The US Department of Energy (DOE) Order 5400.5, ''Radiation Protection of the Public and Environment'' contains provisions pertinent to releasing potentially radioactive materials from DOE facilities for reuse or recycle. A process of authorized release for materials recovered from radiation areas is permitted under Order 5400.5 and the proposed rule in Title 10, Part 834, of the Code of Federal Regulations (10 CFR Part 834). A generic disposition protocol to facilitate release of concrete under these provisions has been developed. This report analyzes the application of that generic protocol to site-specific cases at the Idaho National Engineering and Environmental Laboratory (INEEL). The potential radiological doses and costs for several concrete disposition alternatives for the sewage treatment plant (STP) at the Central Facilities Area (CFA) of INEEL were evaluated in this analysis. Five disposition alternatives were analyzed for the concrete: (A) decontaminate, crush, and reuse; (B) crush and reuse without decontamination; (C) decontaminate, demolish, and dispose of at a nonradiological landfill; (D) demolish and dispose of at a nonradiological landfill without decontamination; and (E) demolish and dispose of at a low-level radioactive waste (LLW) facility. The analysis was performed for disposition of concrete from four INEEL structures: (1) trickle filter, (2) primary clarifier, (3) secondary clarifier, and (4) CFA-691 pumphouse for a generic case (based on default parameters from the disposition protocol) and an INEEL-specific case (based on INEEL-specific parameters). The results of the analysis indicated that Alternatives B and D would incur the lowest cost and result in a dose less than 1 mrem/yr (except for the trickle filter, the dose for which was estimated at 1.9 mrem/yr) for nonradiological workers. The analysis indicated that the main contributor to the radiological dose would be cobalt-60 contamination in the concrete. A characterization conducted

  10. Contacting of authors by systematic reviewers: protocol for a cross-sectional study and a survey.

    Science.gov (United States)

    Meursinge Reynders, Reint; Ladu, Luisa; Di Girolamo, Nicola

    2017-12-08

    Synthesizing outcomes of underreported primary studies can pose a serious threat to the validity of outcomes and conclusions of systematic reviews. To address this problem, the Cochrane Collaboration recommends reviewers to contact authors of eligible primary studies to obtain additional information on poorly reported items. In this protocol, we present a cross-sectional study and a survey to assess (1) how reviewers of new Cochrane intervention reviews report on procedures and outcomes of contacting of authors of primary studies to obtain additional data, (2) how authors reply, and (3) the consequences of these additional data on the outcomes and quality scores in the review. All research questions and methods were pilot tested on 2 months of Cochrane reviews and were subsequently fine-tuned. Eligibility criteria are (1) all new (not-updates) Cochrane intervention reviews published in 2016, (2) reviews that included one or more primary studies, and (3) eligible interventions refer to contacting of authors of the eligible primary studies included in the review to obtain additional research data (e.g., information on unreported or missing data, individual patient data, research methods, and bias issues). Searching for eligible reviews and data extraction will be conducted by two authors independently. The cross-sectional study will primarily focus on how contacting of authors is conducted and reported, how contacted authors reply, and how reviewers report on obtained additional data and their consequences for the review. The same eligible reviews for the cross-sectional study will also be eligible for the survey. Surveys will be sent to the contact addresses of these reviews according to a pre-defined protocol. We will use Google Forms as our survey platform. Surveyees are asked to answer eight questions. The survey will primarily focus on the consequences of contacting authors of eligible primary studies for the risk of bias and Grading of Recommendations

  11. Neurophysiology versus clinical genetics in Rett syndrome: A multicenter study

    Science.gov (United States)

    Halbach, Nicky; Julu, Peter; Witt‐Engerström, Ingegerd; Pini, Giorgio; Bigoni, Stefania; Hansen, Stig; Apartopoulos, Flora; Delamont, Robert; van Roozendaal, Kees; Scusa, Maria F.; Borelli, Paolo; Candel, Math; Curfs, Leopold

    2016-01-01

    Many studies have attempted to establish the genotype–phenotype correlation in Rett syndrome (RTT). Cardiorespiratory measurements provide robust objective data, to correlate with each of the different clinical phenotypes. It has important implications for the management and treatment of this syndrome. The aim of this study was to correlate the genotype with the quantitative cardiorespiratory data obtained by neurophysiological measurement combined with a clinical severity score. This international multicenter study was conducted in four European countries from 1999 to 2012. The study cohort consisted of a group of 132 well‐defined RTT females aged between 2 and 43 years with extended clinical, molecular, and neurophysiological assessments. Diagnosis of RTT was based on the consensus criteria for RTT and molecular confirmation. Genotype–phenotype analyses of clinical features and cardiorespiratory data were performed after grouping mutations by the same type and localization or having the same putative biological effect on the MeCP2 protein, and subsequently on eight single recurrent mutations. A less severe phenotype was seen in females with CTS, p.R133C, and p.R294X mutations. Autonomic disturbances were present in all females, and not restricted to nor influenced by one specific group or any single recurrent mutation. The objective information from non‐invasive neurophysiological evaluation of the disturbed central autonomic control is of great importance in helping to organize the lifelong care for females with RTT. Further research is needed to provide insights into the pathogenesis of autonomic dysfunction, and to develop evidence‐based management in RTT. © 2016 The Authors. American Journal of Medical Genetics Part A published by Wiley Periodicals, Inc. PMID:27354166

  12. The Study and Simulation of Multi-interface Extension for OLSR Protocol

    Directory of Open Access Journals (Sweden)

    Zhong Hui

    2016-01-01

    Full Text Available The way to improve the performance of the throughput in the wireless Mesh network is nodes with multiple interfaces. In view of the problem of multi-interface multi-channel extension for OLSR protocol, multi–interface multi-channel OLSR protocol is proposed. Nodes can have multiple network interfaces, but each node has only one IP, using the index of interface to distinguish the multiple interfaces of the node. Selected the receiving interface according to the channel, modified the message delivery method and introduces the protocol implementation and technology. Finally, the simulation is carried out by using the extended NS2. Simulation results show that extended OLSR protocol has high network performance, and improve the network throughput. What is new and original in this paper is adding multiple physical interface support for proactive protocol OLSR.

  13. Thyroid function and the metabolic syndrome in older persons: a population-based study

    NARCIS (Netherlands)

    Heima, N.E.; Eekhoff, E.M.W.; Oosterwerff, M.M.; Lips, P.T.A.M.; van Schoor, N.M.; Simsek, S.

    2013-01-01

    Background: Studies suggest an association between a high TSH and (individual components of) the metabolic syndrome. Only a few studies have been performed in the general older population. Objective: This study investigates the association between serum TSH and the metabolic syndrome in a

  14. Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol

    Directory of Open Access Journals (Sweden)

    van der Vlugt Maureen J

    2011-02-01

    Full Text Available Abstract Background Cerebral small vessel disease (SVD is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML and the normal appearing white matter (NAWM. Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. Methods/Design The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. Discussion The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white

  15. Brazilian Samba Protocol for Individuals With Parkinson's Disease: A Clinical Non-Randomized Study.

    Science.gov (United States)

    Tillmann, Ana Cristina; Andrade, Alexandro; Swarowsky, Alessandra; Guimarães, Adriana Coutinho De Azevedo

    2017-07-04

    In the 10 most populated countries in the world, Parkinson's disease (PD) affects more than 5 million individuals. Despite optimal treatment options already developed for the disease, concomitant involvement of other areas of health care plays an important role in complementing the treatment. From this perspective, dancing can be viewed as a non-drug alternative that can reduce falls by improving some motor skills, such as mobility, balance, gait, and posture, and can also improve the overall quality of life. Brazilian samba promotes improvement in motor and non-motor symptoms in individuals with PD, providing a new treatment option for this population. The main objective of this quasi-experimental study is to provide a 12-week samba protocol (2x/week) for individuals with PD and to compare its effects with the group without intervention. The hypothesis is that the Brazilian samba protocol will promote improvement in primary (motor) and secondary (non-motor) outcomes in individuals with PD. The sample will be selected at random from individuals diagnosed with PD in the city of Florianopolis (SC, Brazil). Sample size calculation was performed with the G*Power 3.1.9.2 software, with 0.447 effect size, at 5% significance level, power of 0.9, and test and sample loss of 20%. This yielded 60 individuals divided between the intervention and control groups. The questionnaires will be filled out before and after the dance intervention. The data collection for the control group will be held simultaneously to the intervention group. The classes will last for 1 hour, twice a week in the evening for 12 weeks, and all classes will be divided into warm-up, main part, and relaxation. Two-way analysis of variance with repeated measures and Sidak post-hoc comparison test will be used for a comparative analysis of the final results of the control group with the experimental group and of the within-group changes between pre- and postintervention period. We expect to complete follow

  16. Restless legs syndrome and post polio syndrome: a case-control study.

    Science.gov (United States)

    Romigi, A; Pierantozzi, M; Placidi, F; Evangelista, E; Albanese, M; Liguori, C; Nazzaro, M; Risina, B U; Simonelli, V; Izzi, F; Mercuri, N B; Desiato, M T

    2015-03-01

    The aim was to investigate the prevalence of restless legs syndrome (RLS), fatigue and daytime sleepiness in a large cohort of patients affected by post polio syndrome (PPS) and their impact on patient health-related quality of life (HRQoL) compared with healthy subjects. PPS patients were evaluated by means of the Stanford Sleepiness Scale and the Fatigue Severity Scale (FSS). The Short Form Health Survey (SF-36) questionnaire was utilized to assess HRQoL in PPS. RLS was diagnosed when standard criteria were met. Age and sex matched healthy controls were recruited amongst spouses or friends of PPS subjects. A total of 66 PPS patients and 80 healthy controls were enrolled in the study. A significantly higher prevalence of RLS (P < 0.0005; odds ratio 21.5; 95% confidence interval 8.17-57) was found in PPS patients (PPS/RLS+ 63.6%) than in healthy controls (7.5%). The FSS score was higher in PPS/RLS+ than in PPS/RLS- patients (P = 0.03). A significant decrease of SF-36 scores, including the physical function (P = 0.001), physical role (P = 0.0001) and bodily pain (P = 0.03) domains, was found in PPS/RLS+ versus PPS/RLS- patients. Finally, it was found that PPS/RLS+ showed a significant correlation between International Restless Legs Scale score and FSS (P < 0.0001), as well as between International Restless Legs Scale score and most of the SF-36 items (physical role P = 0.0018, general health P = 0.0009, vitality P = 0.0022, social functioning P = 0.002, role emotional P = 0.0019, and mental health P = 0.0003). Our findings demonstrate a high prevalence of RLS in PPS, and that RLS occurrence may significantly influence the HRQoL and fatigue of PPS patients. A hypothetical link between neuroanatomical and inflammatory mechanisms in RLS and PPS is suggested. © 2014 EAN.

  17. Think-Aloud Protocols in Research on Essay Rating: An Empirical Study of Their Veridicality and Reactivity

    Science.gov (United States)

    Barkaoui, Khaled

    2011-01-01

    Think-aloud protocols (TAPs) are frequently used in research on essay rating processes. However, there are very few empirical studies of the completeness of TAP data and the effects of this technique on rater performance (i.e., rating processes and outcomes). This study aims to start to address this research gap. As part of a larger study on rater…

  18. Study of effective dose of various protocols in equipment cone beam CT

    Energy Technology Data Exchange (ETDEWEB)

    Soares, M. R.; Maia, A. F. [Universidade Federale de Sergipe, Departamento de Fisica, Cidade Universitaria Prof. Jose Aloisio de Campos, Marechal Rondon s/n, Jardim Rosa Elze, 49-100000 Sao Cristovao, Sergipe (Brazil); Batista, W. O. [Instituto Federal da Bahia, Rua Emidio dos Santos s/n, Barbalho, Salvador, 40301015 Bahia (Brazil); Caldas, L. V. E.; Lara, P. A., E-mail: mrs2206@gmail.com [Instituto de Pesquisas Energeticas e Nucleares / CNEN, Av. Lineu Prestes 2242, Cidade Universitaria, 05508-000 Sao Paulo (Brazil)

    2014-08-15

    Currently the cone beam computed tomography is widely used in various procedures of dental radiology. Although the doses values associated with the procedures of cone beam CT are low compared to typical values associated with dental radiology procedure in multi slices CT. However can be high compared to typical values of other techniques commonly used in dental radiology. The present scenario is a very wide range of designs of equipment and, consequently, lack of uniformity in all parameters associated with x-ray generation and geometry. In this context, this study aimed to evaluate and calculate the absorbed dose in organs and tissues relevant and estimate effective dose for different protocols with different geometries of exposure in five cone beam CT equipment. For this, a female Alderson anthropomorphic phantom, manufactured by Radiology Support Devices was used. The phantom was irradiated with 26 dosimeters LiF: Mg, Ti (TLD-100), inserted in organs and tissues along the layers forming the head and neck of the phantom. The equipment used, in this present assessment, was: i-CAT Classical, Kodak 9000 3D, Gendex GXCB 500, Sirona Orthophos X G 3D and Planmeca Pro Max 3D. The effective doses were be determined by the ICRP 103 weighting factors. The values were between 7.0 and 111.5 micro Sv, confirming the broad dose range expected due to the diversity of equipment and protocols used in each equipment. The values of effective dose per Fov size were: between 7 and 51.2 micro Sv for located Fov; between 17.6 and 52.0 micro Sv for medium Fov; and between 11.5 and 43.1 micro Sv to large Fov (maxillofacial). In obtaining the effective dose the measurements highlighted a relevance contribution of dose absorbed by the remaining organs (36%), Salivary glands (30%), thyroid (12%) and bone marrow (12%). (Author)

  19. Design, rationale and feasibility of a multidimensional experimental protocol to study early life stress

    Directory of Open Access Journals (Sweden)

    M. Dillwyn Bartholomeusz

    2017-09-01

    Full Text Available There is a rapidly accumulating body of evidence regarding the influential role of early life stress (ELS upon medical and psychiatric conditions. While self-report instruments, with their intrinsic limitations of recall, remain the primary means of detecting ELS in humans, biological measures are generally limited to a single biological system. This paper describes the design, rationale and feasibility of a study to simultaneously measure neuroendocrine, immune and autonomic nervous system (ANS responses to psychological and physiological stressors in relation to ELS. Five healthy university students were recruited by advertisement. Exclusion criteria included chronic medical conditions, psychotic disorders, needle phobia, inability to tolerate pain, and those using anti-inflammatory medications. They were clinically interviewed and physiological recordings made over a two-hour period pre, during and post two acute stressors: the cold pressor test and recalling a distressing memory. The Childhood Trauma Questionnaire and the Parental Bonding Index were utilised to measure ELS. Other psychological measures of mood and personality were also administered. Measurements of heart rate, blood pressure, respiratory rate, skin conductance, skin blood flow and temporal plasma samples were successfully obtained before, during and after acute stress. Participants reported the extensive psychological and multisystem physiological data collection and stress provocations were tolerable. Most (4/5 participants indicated a willingness to return to repeat the protocol, indicating acceptability. Our protocol is viable and safe in young physically healthy adults and allows us to assess simultaneously neuroendocrine, immune and autonomic nervous system responses to stressors in persons assessed for ELS. Keywords: Childhood-stress, Adverse-childhood-events, Childhood-trauma questionnaire, Parental-bonding-instrument, Type D scale (DS14

  20. Study of effective dose of various protocols in equipment cone beam CT

    International Nuclear Information System (INIS)

    Soares, M. R.; Maia, A. F.; Batista, W. O.; Caldas, L. V. E.; Lara, P. A.

    2014-08-01

    Currently the cone beam computed tomography is widely used in various procedures of dental radiology. Although the doses values associated with the procedures of cone beam CT are low compared to typical values associated with dental radiology procedure in multi slices CT. However can be high compared to typical values of other techniques commonly used in dental radiology. The present scenario is a very wide range of designs of equipment and, consequently, lack of uniformity in all parameters associated with x-ray generation and geometry. In this context, this study aimed to evaluate and calculate the absorbed dose in organs and tissues relevant and estimate effective dose for different protocols with different geometries of exposure in five cone beam CT equipment. For this, a female Alderson anthropomorphic phantom, manufactured by Radiology Support Devices was used. The phantom was irradiated with 26 dosimeters LiF: Mg, Ti (TLD-100), inserted in organs and tissues along the layers forming the head and neck of the phantom. The equipment used, in this present assessment, was: i-CAT Classical, Kodak 9000 3D, Gendex GXCB 500, Sirona Orthophos X G 3D and Planmeca Pro Max 3D. The effective doses were be determined by the ICRP 103 weighting factors. The values were between 7.0 and 111.5 micro Sv, confirming the broad dose range expected due to the diversity of equipment and protocols used in each equipment. The values of effective dose per Fov size were: between 7 and 51.2 micro Sv for located Fov; between 17.6 and 52.0 micro Sv for medium Fov; and between 11.5 and 43.1 micro Sv to large Fov (maxillofacial). In obtaining the effective dose the measurements highlighted a relevance contribution of dose absorbed by the remaining organs (36%), Salivary glands (30%), thyroid (12%) and bone marrow (12%). (Author)

  1. Restless Legs Syndrome and Cognitive Function: A Population-based Cross-sectional Study.

    Science.gov (United States)

    Rist, Pamela M; Elbaz, Alexis; Dufouil, Carole; Tzourio, Christophe; Kurth, Tobias

    2015-09-01

    Restless legs syndrome has been speculated to be linked to cognitive impairment through vascular risk factors or through its effect on sleep deprivation. Previous studies on the association between restless legs syndrome and cognitive function have been inconclusive. We performed a cross-sectional analysis of the association between restless legs syndrome and cognitive function using data from a large population-based study of elderly individuals residing in France. We used information from 2070 individuals from the Dijon, France center of the Three-City study who had available information on restless legs syndrome and cognitive functioning measures. Restless legs syndrome was assessed using the 4 minimal diagnostic criteria of the International Restless Legs Study Group. During the same wave in which restless legs syndrome status was assessed, cognitive functions also were assessed using 4 tests: Isaacs' test of verbal/category fluency, the Benton Visual Retention Test, the Trail Making Test B, and the Mini-Mental State Examination. We created a summary global cognitive score by summing the z scores for the 4 tests and used analysis of covariance to explore the association between restless legs syndrome and cognitive function. We did not observe any statistically significant differences in any cognitive z-score between those with restless legs syndrome and those without restless legs syndrome. The mean global z-score after multivariate adjustment was -0.003 (SE 0.173) for those with restless legs syndrome and -0.007 (SE 0.129) for those without restless legs syndrome (P-value = .98). Data from this large, population-based study do not suggest that restless legs syndrome is associated with prevalent cognitive deficits in elderly individuals. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Study of abdominal MR imaging in hemolytic-uremic syndrome

    Energy Technology Data Exchange (ETDEWEB)

    Yamazaki, Takeshi; Mori, Yasuhiko; Takenaka, Yoshito [Osaka Rosai Hospital, Sakai (Japan)] [and others

    1995-09-01

    This study was performed to examine the usefulness of MR imaging in predicting disease course of hemolytic-uremic syndrome (HUS). The subjects were 7 HUS child patients, including 2 who underwent transfusion, whose ages ranged from one year and nine months to 6 years and nine months. Abdominal MR imaging was performed between 3 days and 11 months from the onset of HUS. Cortico-medullary differentiation (CMD) in the kidney disappeared on T1-weighted images in 4 patients. The presence or absence of CMD was suggested to reflect the renal function, especially glomerular function. T2-weighted images showed low signal intensities in the liver and spleen in 4 patients, which was considered to be due to hemosiderin precipitation, suggesting a correlation with disease stage and transfusion. (Y.S.).

  3. Protocol for the prospective validation study: 'Screening programme for pre-eclampsia' (SPREE).

    Science.gov (United States)

    Tan, M Y; Koutoulas, L; Wright, D; Nicolaides, K H; Poon, L C Y

    2017-08-01

    Pre-eclampsia (PE), which affects about 2% of pregnancies, is a major cause of maternal and perinatal morbidity and mortality. Early detection of PE can improve pregnancy outcome by providing timely intervention and closer monitoring. The current guideline from the UK National Institute for Health and Care Excellence (NICE) recommends that, at the booking visit, women identified with one major risk factor or more than one moderate risk factor for PE should be advised to take low-dose aspirin daily from 12 weeks until delivery. However, performance of the current method of screening is poor and identifies only about 35% of PE. Extensive studies in the last decade have established that the best performance for early prediction of PE can be achieved by using a novel Bayes' theorem-based method that combines maternal characteristics and medical history together with measurements of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI), serum placental growth factor (PlGF) and pregnancy-associated plasma protein-A (PAPP-A) at 11-13 weeks' gestation. This forms the 'combined test', which could be simplified to the 'mini combined test' when only maternal factors, MAP and PAPP-A are taken into consideration. We present the protocol (version 3.1, 14 November 2016) for the 'Screening programme for pre-eclampsia' (SPREE) study, a prospective multicenter cohort study that will be carried out in seven National Health Service maternity hospitals in England. Eligible pregnant women attending their routine scan at 11-13 weeks' gestation will be invited to participate in this study. Maternal characteristics and history and measurements of MAP, UtA-PI, serum PAPP-A and PlGF will be recorded according to standardized protocols. The patient-specific risk for PE will be calculated and data on pregnancy outcomes collected. We hypothesize that the first-trimester mini combined test and combined test for PE screening, using the Bayes' theorem-based method, are likely to

  4. Parental intimate partner homicide and its consequences for children: protocol for a population-based study.

    Science.gov (United States)

    Alisic, Eva; Groot, Arend; Snetselaar, Hanneke; Stroeken, Tielke; van de Putte, Elise

    2015-07-29

    The loss of a parent due to intimate partner homicide has a major impact on children. Professionals involved have to make far-reaching decisions regarding placement, guardianship, mental health care and contact with the perpetrating parent, without an evidence base to guide these decisions. We introduce a study protocol to a) systematically describe the demographics, circumstances, mental health and wellbeing of children bereaved by intimate partner homicide and b) build a predictive model of factors associated with children's mental health and wellbeing after intimate partner homicide. This study focuses on children bereaved by parental intimate partner homicide in the Netherlands over a period of 20 years (1993 - 2012). It involves an incidence study to identify all Dutch intimate partner homicide cases between 1993 and 2012 by which children have been bereaved; systematic case reviews to describe the demographics, circumstances and care trajectories of these children; and a mixed-methods study to assess mental health, wellbeing, and experiences regarding decisions made and care provided. Clinical experience and initial research suggest that the children involved often need long-term intensive mental health and case management. The costs of these services are extensive and the stakes are high. This study lays the foundation for an international dataset and evidence-informed decision making.

  5. Genetic study of a new X-linked recessive immunodeficiency syndrome.

    OpenAIRE

    de Saint-Basile, G; Le Deist, F; Caniglia, M; Lebranchu, Y; Griscelli, C; Fischer, A

    1992-01-01

    Seven forms of X-linked (XL) immunodeficiency have been described (XL agammaglobulinemia, XL severe combined immunodeficiency [SCID], Wiskott-Aldrich syndrome, XL chronic granulomatous disease, XL hyper-IgM syndrome with low IgG and IgA, and XL lymphoproliferative syndrome), and properdine deficiency. Although there are (some) phenotypic variants, diagnosis is relatively simple on the basis of clinical, immunological, and genetic characteristics. We studied a family in which several males wer...

  6. EFFECT OF DANCE EXERCISE ON COGNITIVE FUNCTION IN ELDERLY PATIENTS WITH METABOLIC SYNDROME: A PILOT STUDY

    OpenAIRE

    Sang-Wook Song; Seo-Jin Park; Jung-hyoun Cho; Sung-Goo Kang; Hyun-Kook Lim; Yu-Bae Ahn; Minjeong Kim; Se-Hong Kim

    2011-01-01

    Metabolic syndrome is associated with an increased risk of cognitive impairment. The purpose of this prospective pilot study was to examine the effects of dance exercise on cognitive function in elderly patients with metabolic syndrome. The participants included 38 elderly metabolic syndrome patients with normal cognitive function (26 exercise group and 12 control group). The exercise group performed dance exercise twice a week for 6 months. Cognitive function was assessed in all participants...

  7. Study of Testicular Structure in Fetuses with Prune Belly Syndrome

    Directory of Open Access Journals (Sweden)

    Luciano A. Favorito

    2017-01-01

    Full Text Available Purpose. To compare the structure of the testis in fetuses with prune belly syndrome (PBS to normal controls. Materials and Methods. We studied 6 testes obtained from 3 fetuses with PBS and 14 testes from 7 male fetuses. The testicular specimens were cut into 5-μm thick sections and stained with hematoxylin and eosin (HE, to observe the seminiferous tubules; Weigert’s solution to observe elastic fibers; and picrosirius red to observe collagen. The images were captured with an Olympus BX51 microscope and Olympus DP70 camera. The stereological analysis was done with the Image Pro and Image J programs. Means were statistically compared using the Mann–Whitney U test (p<0.005. Results. Quantitative analysis documented no differences (p=0.4 in number of seminiferous tubules (ST in PBS testes (mean = 8.87%, SD=1.59, when compared to the control (mean = 11.4%, SD=2.99 and no differences (p=0.8 in diameter of ST in PBS testes (mean = 52.85 μm, SD=1.58 when compared to the control group (mean = 53.17 μm, SD=1.55, but we did observe a lower number (p=0.0002 of Leydig cells in the PBS testes (mean = 67.03% and SD=3.697 when compared to the control group (mean = 90.1% and SD=2.986. Conclusions. Our study showed a lower concentration of Leydig cells in the triad syndrome fetuses.

  8. An exploratory study of cannabis withdrawal among Indigenous Australian prison inmates: study protocol.

    Science.gov (United States)

    Rogerson, Bernadette; Copeland, Jan; Buttner, Petra; Bohanna, India; Cadet-James, Yvonne; Sarnyai, Zoltan; Clough, Alan R

    2013-05-28

    Cannabis use and dependence is a serious health and criminal justice issue among incarcerated populations internationally. Upon abrupt, enforced cessation of cannabis, prisoners may suffer irritability and anger that can lead to threatening behaviour, intimidation, violence, sleep disturbances and self-harm. Cannabis withdrawal syndrome, proposed for inclusion in the Diagnostic and Statistical Manual of Mental Disorders in 2013, has not been examined in Indigenous populations. Owing to the exceptionally high rates of cannabis use in the community, high proportions of Australian Indigenous prisoners may suffer from withdrawal upon entry to custody. 60 male and 60 female Indigenous prisoners (18-40 years) at a high risk of cannabis dependence will be recruited upon entry to custody. A pictorial representation of the standard Cannabis Withdrawal Scale will be tested for reliability and validity. Cortisol markers will be measured in saliva, as the indicators of onset and severity of cannabis withdrawal and psychological distress. The characteristics will be described as percentages and mean or median values with 95% CI. Receiver operator curve analysis will determine an ideal cut-off of the Cannabis Withdrawal Scale and generalised estimating equations modelling will test changes over time. The acceptability and efficacy of proposed resources will be assessed qualitatively using thematic analysis. A valid and reliable measure of cannabis withdrawal for use with Indigenous populations, the onset and time course of withdrawal symptoms in this population and the development of culturally acceptable resources and interventions to identify and manage cannabis withdrawal. The project has been approved by the James Cook University Human Research Ethics Committee (approval number H4651).The results will be reported via peer reviewed publications, conference, seminar presentations and on-line media for national and international dissemination.

  9. Bioremediation protocols

    National Research Council Canada - National Science Library

    Sheehan, David

    1997-01-01

    ..., .. . . . . .. ,. . . .. . . . . . . . .. . . . . .. . . .. . .. 3 2 Granular Nina Sludge Christiansen, Consortia lndra for Bioremediation, M. Mathrani, and Birgitte K. Ahring . 23 PART II PROTOCOLS...

  10. Asperger syndrome related suicidal behavior: two case studies

    OpenAIRE

    Kocourkova J; Dudova I; Koutek J

    2013-01-01

    Jana Kocourkova, Iva Dudova, Jiri Koutek Department of Child Psychiatry, Charles University Second Faculty of Medicine, University Hospital Motol, Prague, Czech Republic Abstract: Asperger syndrome hinders adaptation to developmental challenges during childhood and adolescence, particularly with regard to interpersonal relationships. Individuals with Asperger syndrome display lack of empathy and limited ability to understand social and emotional exchanges with other people. Individuals with ...

  11. Thrombocytopenia-absent radius syndrome: a clinical genetic study.

    NARCIS (Netherlands)

    Greenhalgh, K.L.; Howell, R.; Bottani, A.; Ancliff, P.J.; Brunner, H.G.; Verschuuren-Bemelmans, C.C.; Vernon, E.; Brown, K.W.; Newbury-Ecob, R.

    2002-01-01

    The thrombocytopenia-absent radius (TAR) syndrome is a congenital malformation syndrome characterised by bilateral absence of the radii and a thrombocytopenia. The lower limbs, gastrointestinal, cardiovascular, and other systems may also be involved. Shaw and Oliver in 1959 were the first to

  12. Thrombocytopenia-absent radius syndrome : a clinical genetic study

    NARCIS (Netherlands)

    Greenhalgh, KL; Howell, RT; Bottani, A; Ancliff, PJ; Brunner, HG; Verschuuren-Bemelmans, CC; Vernon, E; Brown, KW; Newbury-Ecob, RA

    2002-01-01

    The thrombocytopenia-absent radius (TAR) syndrome is a congenital malformation syndrome characterised by bilateral absence of the radii and a thrombocytopenia. The lower limbs, gastrointestinal, cardiovascular, and other systems may also be involved. Shaw and Oliver in 1959 were the first to

  13. Short and long-term effectiveness of couple counselling: a study protocol

    Directory of Open Access Journals (Sweden)

    Schofield Margot J

    2012-09-01

    Full Text Available Abstract Background Healthy couple relationships are fundamental to a healthy society, whereas relationship breakdown and discord are linked to a wide range of negative health and wellbeing outcomes. Two types of relationship services (couple counselling and relationship education have demonstrated efficacy in many controlled studies but evidence of the effectiveness of community-based relationship services has lagged behind. This study protocol describes an effectiveness evaluation of the two types of community-based relationship services. The aims of the Evaluation of Couple Counselling study are to: map the profiles of clients seeking agency-based couple counselling and relationship enhancement programs in terms of socio-demographic, relationship, health, and health service use indicators; to determine 3 and 12-month outcomes for relationship satisfaction, commitment, and depression; and determine relative contributions of client and therapy factors to outcomes. Methods/Design A quasi-experimental pre-post-post evaluation design is used to assess outcomes for couples presenting for the two types of community-based relationship services. The longitudinal design involves a pre-treatment survey and two follow-up surveys at 3- and 12-months post-intervention. The study is set in eight Relationships Australia Victoria centres, across metropolitan, outer suburbs, and regional/rural sites. Relationships Australia, a non-government organisation, is the largest provider of couple counselling and relationship services in Australia. The key outcomes are couple satisfaction, relationship commitment, and depression measured by the CESD-10. Multi-level modelling will be used to account for the dyadic nature of couple data. Discussion The study protocol describes the first large scale investigation of the effectiveness of two types of relationship services to be conducted in Australia. Its significance lies in providing more detailed profiles of couples who

  14. The role of xerostomia in burning mouth syndrome: a case-control study

    Directory of Open Access Journals (Sweden)

    Luciana Alvarenga da Silva

    2014-02-01

    Full Text Available Objective : To assess the efficacy of anti-xerostomic topical medication (urea 10% in patients with burning mouth syndrome (BMS. Method : Thirty-eight subjects diagnosed with BMS according to the International Association for the Study of Pain guidelines were randomized to either placebo (5% sodium carboxymethylcellulose, 0.15% methyl paraben, and 10% glycerol in distilled water qsp 100 g or treatment (urea 10% to be applied to the oral cavity 3-4 times per day for 3 months. The patients were evaluated before and after treatment with the following instruments: the EDOF-HC protocol (Orofacial Pain Clinic – Hospital das Clínicas, a xerostomia questionnaire, and quantitative sensory testing. Results : There were no differences in salivary flow or gustative, olfactory, or sensory thresholds (P>0.05. Fifteen (60% patients reported improvement with the treatments (P=0.336. Conclusion : In conclusion, there were no differences between groups, and both exhibited an association between reported improvement and salivation.

  15. Wearable Monitoring Devices for Assistive Technology: Case Studies in Post-Polio Syndrome

    Directory of Open Access Journals (Sweden)

    Giuseppe Andreoni

    2014-01-01

    Full Text Available The correct choice and customization of an orthosis are crucial to obtain the best comfort and efficiency. This study explored the feasibility of a multivariate quantitative assessment of the functional efficiency of lower limb orthosis through a novel wearable system. Gait basographic parameters and energetic indexes were analysed during a Six-Minute Walking Test (6-MWT through a cost-effective, non-invasive polygraph device, with a multichannel wireless transmission, that carried out electro-cardiograph (ECG; impedance-cardiograph (ICG; and lower-limb accelerations detection. Four subjects affected by Post-Polio Syndrome (PPS were recruited. The wearable device and the semi-automatic post-processing software provided a novel set of objective data to assess the overall efficiency of the patient-orthosis system. Despite the small number of examined subjects, the results obtained with this new approach encourage the application of the method thus enlarging the dataset to validate this promising protocol and measuring system in supporting clinical decisions and out of a laboratory environment.

  16. Histomorphometric assessment of bone necrosis produced by two cryosurgery protocols using liquid nitrogen: an experimental study on rat femurs

    Directory of Open Access Journals (Sweden)

    Fábio Wildson Gurgel Costa

    2011-12-01

    Full Text Available OBJECTIVE: The aim of this study was to evaluate the effects of liquid nitrogen cryosurgery on the femoral diaphysis of rats. MATERIAL AND METHODS: The femoral diaphyses of 42 Wistar rats were exposed to three local and sequential applications of liquid nitrogen for 1 or 2 min, intercalated with periods of 5 min of passive thawing. The animals were sacrificed after 1, 2, 4 and 12 weeks and the specimens obtained were processed and analyzed histomorphometrically. RESULTS: The depth and extent of peak bone necrosis were 124.509 µm and 2087.094 µm for the 1-min protocol, respectively, and 436.424 µm and 12046.426 µm for the 2-min protocol. Peak necrosis was observed in the second experimental week with both cryotherapy protocols. CONCLUSIONS: The present results indicate that the 2-min protocol produced more marked bone necrosis than the 1-min protocol. Although our results cannot be entirely extrapolated to clinical practice, they contribute to the understanding of the behavior of bone tissue submitted to different cycles of liquid nitrogen freezing and may serve as a basis for new studies.

  17. Ex post facto assessment of diffusion tensor imaging metrics from different MRI protocols: preparing for multicentre studies in ALS.

    Science.gov (United States)

    Rosskopf, Johannes; Müller, Hans-Peter; Dreyhaupt, Jens; Gorges, Martin; Ludolph, Albert C; Kassubek, Jan

    2015-03-01

    Diffusion tensor imaging (DTI) for assessing ALS-associated white matter alterations has still not reached the level of a neuroimaging biomarker. Since large-scale multicentre DTI studies in ALS may be hampered by differences in scanning protocols, an approach for pooling of DTI data acquired with different protocols was investigated. Three hundred and nine datasets from 170 ALS patients and 139 controls were collected ex post facto from a monocentric database reflecting different scanning protocols. A 3D correction algorithm was introduced for a combined analysis of DTI metrics despite different acquisition protocols, with the focus on the CST as the tract correlate of ALS neuropathological stage 1. A homogenous set of data was obtained by application of 3D correction matrices. Results showed that a fractional anisotropy (FA) threshold of 0.41 could be defined to discriminate ALS patients from controls (sensitivity/specificity, 74%/72%). For the remaining test sample, sensitivity/specificity values of 68%/74% were obtained. In conclusion, the objective was to merge data recorded with different DTI protocols with 3D correction matrices for analyses at group level. These post processing tools might facilitate analysis of large study samples in a multicentre setting for DTI analysis at group level to aid in establishing DTI as a non-invasive biomarker for ALS.

  18. Flow rate calibration II: a clinical evaluation study using PanLeucoGating as a single-platform protocol.

    Science.gov (United States)

    Storie, Ian; Sawle, Alex; Whitby, Liam; Goodfellow, Karen; Granger, Vivian; Reilly, John T; Barnett, David

    2003-09-01

    CD4(+) T-lymphocyte enumeration is vital for monitoring disease progression in individuals positive for the human immunodeficiency virus (HIV), and as a result, there is a need to develop cost-effective protocols that provide accuracy, precision, and affordability. Recently, PanLeucoGating has been shown to fulfill these requirements; however, although comparable to state-of-the-art single-platform protocols (SP), there is still a requirement for an accurate total white cell count. To overcome this limitation, we recently developed a flow-rate based calibration method that enables the PanLeucoGating protocol to be used as a SP approach, and in this study show that this approach can be used for CD4(+) T-lymphocyte enumeration. A total of 113 HIV samples were analyzed using three protocols: (a) state-of-the art SP bead-based method (MultiSet; predicate protocol), (b) PanLeucoGating protocol used as a dual-platform (DP) approach, and (c) the newly developed flow rate-based SP approach. We demonstrate that flow rate calibration can be achieved easily and that the method is highly comparable to the state-of-the-art SP method. A high correlation was observed between the predicate protocol and the SP PanLeucoGating approach over the whole range of CD4 counts tested (r(2) = 0.9928; bias 8 cells/microl), including the clinically relevant range (e.g., 0-200 CD4 cells/microl; bias 0 cells/microl). For batched samples, the cost of providing a CD4(+) T-lymphocyte count was reduced to approximately US $1. The SP PanLeucoGating is a cost-effective approach to CD4(+) T-lymphocyte enumeration that maintains accuracy and precision. Copyright 2003 Wiley-Liss, Inc.

  19. Prophylactic antidepressant treatment following acute coronary syndrome

    DEFF Research Database (Denmark)

    Christiansen, Ole G; Madsen, Michael T; Simonsen, Erik

    2017-01-01

    the current evidence of primary prophylactic treatment of depression in patients after acute coronary syndrome. The study protocol was prospectively registered at PROSPERO (registration number CRD42015025587). A systematic review were conducted and reported according to Preferred Reporting Items......Major depressive disorder is significantly increased in patients following acute coronary syndrome resulting in twofold increased mortality compared with patients without depression. The depression diagnosis is often missed leading to considerable undertreatment. This systematic review assesses...

  20. Static postural sway of women with and without fibromyalgia syndrome: A cross-sectional study.

    Science.gov (United States)

    Trevisan, Deborah Colucci; Driusso, Patricia; Avila, Mariana Arias; Gramani-Say, Karina; Moreira, Fernando Manuel Araujo; Parizotto, Nivaldo Antonio

    2017-05-01

    There is a frequent complaint about balance problems among fibromyalgia syndrome patients; however, there are not enough studies that have shown static postural sway of women with fibromyalgia syndrome. This study aimed to compare static postural sway of women with and without fibromyalgia syndrome. This is a cross-sectional study in which twenty-nine women with fibromyalgia syndrome and 20 without took part. A posturography evaluation was performed in six different situations (bipedal, right tandem and left tandem, with eyes opened and closed), and questionnaires for clinical depression symptoms, clinical anxiety symptoms, sleep quality, and Visual Analogue Scales for Pain and Fatigue were applied. Mann-Whitney U test was used to check differences among groups; Wilcoxon matched-pair test was used to check differences intragroup; Cohen d coefficient was used to measure effect sizes and Pearson Correlation Coefficient was used for correlations among variables. Level of significance adopted was 5%. Women with fibromyalgia syndrome have presented worse postural sway than women without fibromyalgia syndrome in all situations (Pfibromyalgia syndrome presented worse postural sway than women without in the same conditions. Women with fibromyalgia syndrome have worse performance in the static posture test, more prominent in reduced support bases with eyes closed. Pain, fatigue, depression and anxiety may have directly influenced postural sway in fibromyalgia syndrome patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. A study on phenomenology of Dhat syndrome in men in a general medical setting.

    Science.gov (United States)

    Prakash, Sathya; Sharan, Pratap; Sood, Mamta

    2016-01-01

    "Dhat syndrome" is believed to be a culture-bound syndrome of the Indian subcontinent. Although many studies have been performed, many have methodological limitations and there is a lack of agreement in many areas. The aim is to study the phenomenology of "Dhat syndrome" in men and to explore the possibility of subtypes within this entity. It is a cross-sectional descriptive study conducted at a sex and marriage counseling clinic of a tertiary care teaching hospital in Northern India. An operational definition and assessment instrument for "Dhat syndrome" was developed after taking all concerned stakeholders into account and review of literature. It was applied on 100 patients along with socio-demographic profile, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Mini International Neuropsychiatric Interview, and Postgraduate Institute Neuroticism Scale. For statistical analysis, descriptive statistics, group comparisons, and Pearson's product moment correlations were carried out. Factor analysis and cluster analysis were done to determine the factor structure and subtypes of "Dhat syndrome." A diagnostic and assessment instrument for "Dhat syndrome" has been developed and the phenomenology in 100 patients has been described. Both the health beliefs scale and associated symptoms scale demonstrated a three-factor structure. The patients with "Dhat syndrome" could be categorized into three clusters based on severity. There appears to be a significant agreement among various stakeholders on the phenomenology of "Dhat syndrome" although some differences exist. "Dhat syndrome" could be subtyped into three clusters based on severity.

  2. TABADO: "Evaluation of a smoking cessation program among Adolescents in Vocational Training Centers": Study protocol

    Directory of Open Access Journals (Sweden)

    Martinet Yves

    2009-11-01

    Full Text Available Abstract Background Most of the efforts to reduce teenagers' tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program (TABADO study, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees, was developed. This study aims to evaluate the efficacy of the program which was offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC. This paper presents the TABADO study protocol. Methods The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC in Lorraine, France, during the 2008-2009 period. The intervention group (1000 trainees benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months. Discussion If the program proves effective, it will be a new tool in the action against smoking in populations that have been seldom targeted until now. In addition, the approach could be expanded to other young subjects from socially disadvantaged backgrounds in the context of a public health policy against smoking among adolescents. Trial registration Clinical trial identification number is NTC00973570.

  3. Wayfinding in ageing and Alzheimer's disease within a virtual senior residence: study protocol.

    Science.gov (United States)

    Davis, Rebecca; Ohman, Jennifer

    2016-07-01

    To report a study protocol that examines the impact of adding salient cues in a virtual reality simulation of a senior residential building on wayfinding for older adults with and without Alzheimer's disease. An early symptom of Alzheimer's disease is the inability to find one's way (wayfinding). Senior residential environments are especially difficult for wayfinding. Salient cues may be able to help persons with Alzheimer's disease find their way more effectively so they can maintain independence. A repeated measures, within and between subjects design. This study was funded by the National Institutes of Health (August 2012). Older adults (N = 40) with normal cognition and older adults with early stage Alzheimer's disease/mild cognitive impairment (N = 40) will try to find their way to a location repeatedly in a virtual reality simulation of senior residence. There are two environments: standard (no cues) and salient (multiple cues). Outcome measures include how often and how quickly participants find the target location in each cue condition. The results of this study have the potential to provide evidence for ways to make the environment more supportive for wayfinding for older adults with Alzheimer's disease. This study is registered at Trialmatch.alz.org (Identifier 260425-5). © 2016 John Wiley & Sons Ltd.

  4. A Study of Early Fine Motor Intervention in Down's Syndrome Children

    Science.gov (United States)

    Aparicio, Teresa Sanz; Balana, Javier Menendez

    2009-01-01

    The marked delay in acquisition of fine motor skills in trisomic-21/Down's syndrome children is undeniable. In this study, we began with an affirmation that the cause of this deficit could be found in a different environment for which early intervention is essential. A sample of 30 Down's syndrome children was used to study at different ages: six…

  5. Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hayes Loran P

    2011-05-01

    Full Text Available Abstract Background This protocol is for a study of a new program to improve outcomes in children suffering from chronic pain disorders, such as fibromyalgia, recurrent headache, or recurrent abdominal pain. Although teaching active pain self-management skills through cognitive-behavioral therapy (CBT or a complementary program such as hypnotherapy or yoga has been shown to improve pain and functioning, children with low expectations of skill-building programs may lack motivation to comply with therapists' recommendations. This study will develop and test a new manualized peer-mentorship program which will provide modeling and reinforcement by peers to other adolescents with chronic pain (the mentored participants. The mentorship program will encourage mentored participants to engage in therapies that promote the learning of pain self-management skills and to support the mentored participants' practice of these skills. The study will examine the feasibility of this intervention for both mentors and mentored participants, and will assess the preliminary effectiveness of this program on mentored participants' pain and functional disability. Methods This protocol will recruit adolescents ages 12-17 with chronic pain and randomly assign them to either peer mentorship or a treatment-as-usual control group. Mentored participants will be matched with peer mentors of similar age (ages 14-18 who have actively participated in various treatment modalities through the UCLA Pediatric Pain Program and have learned to function successfully with a chronic pain disorder. The mentors will present information to mentored participants in a supervised and monitored telephone interaction for 2 months to encourage participation in skill-building programs. The control group will receive usual care but without the mentorship intervention. Mentored and control subjects' pain and functioning will be assessed at 2 months (end of intervention for mentored participants and

  6. The Dresden Burnout Study: Protocol of a prospective cohort study for the bio-psychological investigation of burnout.

    Science.gov (United States)

    Penz, Marlene; Wekenborg, Magdalena K; Pieper, Lars; Beesdo-Baum, Katja; Walther, Andreas; Miller, Robert; Stalder, Tobias; Kirschbaum, Clemens

    2018-04-03

    The Dresden Burnout Study (DBS) is a 12-year longitudinal cohort study that aims to provide a description of the burnout syndrome on the basis of time and symptom criteria with a special focus on the search for biomarkers. Biological and psychosocial approaches are applied to examine the long-term course and consequences of burnout within a population-based German-speaking sample aged 18 to 68 years. Demographics and psychosocial data are generated by online assessments, including demographics and questionnaires on burnout, burnout-related constructs, work-environment, and health-related factors. The lab-based biomarker assessment includes endocrine, physiological, immunological, and epigenetic markers obtained from blood and hair samples. In addition, heart rate variability is also measured repeatedly. Within the first 2 years, the DBS collected psychosocial data from over 7,600 participants with biological data obtained from more than 800 individuals. During the following 10 years, detailed assessments of biomarkers and psychosocial factors will be collected in annual study waves. Results will be generated during the following decade. The findings of the DBS are expected to pave the road for an in-depth biopsychosocial characterization of burnout and to give insight into the long-term course and potential mental and physical health consequences of the burnout syndrome. Copyright © 2018 John Wiley & Sons, Ltd.

  7. Association between obesity and depression in patients with diabetes mellitus type 2; a study protocol.

    Science.gov (United States)

    De la Cruz-Cano, Eduardo; Tovilla-Zarate, Carlos Alfonso; Reyes-Ramos, Emilio; Gonzalez-Castro, Thelma Beatriz; Juarez-Castro, Isela; López-Narváez, Maria Lilia; Fresan, Ana

    2015-01-01

    Diabetes mellitus and depression are highly prevalent conditions throughout the world and have significant impact on health outcomes. It has been estimated that diabetes mellitus type 2 affects about 246 million people in the world; nevertheless, incidence varies among countries. There is evidence that depression is associated with a poor metabolic control in patients with type 2 diabetes mellitus that present other health problems (such as hypertension and obesity). The aim of this study protocol is to determine if obesity increases the risk for depression in patient with diabetes type 2. The analysis will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).The studies suitable for inclusion will be assessed by the Newcastle-Ottawa Scale (NOS) to determine their methodological quality. To identify the studies of interest, we will search on PubMed and EBSCO databases. We will use the following keyword combinations: "Diabetes Mellitus type 2 AND obesity AND depression", "depression AND Diabetes Mellitus type 2", "Diabetes Mellitus type 2 AND body mass index cross sectional study", "depression AND obesity cross-sectional study". Causes for exclusion will be publications that studied patients diagnosed with diabetes mellitus type 1; articles that focused on the treatment and complications of diabetes mellitus type 2; publications that have studied other clinical or psychiatric conditions (for instance, seizure disorder or history of schizophrenia, bipolar disorder, psychotic symptoms or dementia). The results of this study will form the basis for a better understanding of the association between obesity and depression in patients with diabetes mellitus type 2, and will allow development of prediction tools and better interventions. It is evident that several modifiable and non-modifiable risk factors play an important role in the pathogenesis of diabetes among population. Currently, evidence for the deleterious effects

  8. Health risk behaviours amongst school adolescents: protocol for a mixed methods study

    Directory of Open Access Journals (Sweden)

    Youness El Achhab

    2016-11-01

    Full Text Available Abstract Background Determining risky behaviours of adolescents provides valuable information for designing appropriate intervention programmes for advancing adolescent’s health. However, these behaviours are not fully addressed by researchers in a comprehensive approach. We report the protocol of a mixed methods study designed to investigate the health risk behaviours of Moroccan adolescents with the goal of identifying suitable strategies to address their health concerns. Methods We used a sequential two-phase explanatory mixed method study design. The approach begins with the collection of quantitative data, followed by the collection of qualitative data to explain and enrich the quantitative findings. In the first phase, the global school-based student health survey (GSHS was administered to 800 students who were between 14 and 19 years of age. The second phase engaged adolescents, parents and teachers in focus groups and assessed education documents to explore the level of coverage of health education in the programme learnt in the middle school. To obtain opinions about strategies to reduce Moroccan adolescents’ health risk behaviours, a nominal group technique will be used. Discussion The findings of this mixed methods sequential explanatory study provide insights into the risk behaviours that need to be considered if intervention programmes and preventive strategies are to be designed to promote adolescent’s health in the Moroccan school.

  9. Design, Implementation, and Study Protocol of a Kindergarten-Based Health Promotion Intervention

    Directory of Open Access Journals (Sweden)

    Susanne Kobel

    2017-01-01

    Full Text Available Inactivity and an unhealthy diet amongst others have led to an increased prevalence of overweight and obesity even in young children. Since most health behaviours develop during childhood health promotion has to start early. The setting kindergarten has been shown as ideal for such interventions. “Join the Healthy Boat” is a kindergarten-based health promotion programme with a cluster-randomised study focussing on increased physical activity, reduced screen media use, and sugar-sweetened beverages, as well as a higher fruit and vegetable intake. Intervention and materials were developed using Bartholomew’s Intervention Mapping approach considering Bandura’s social-cognitive theory and Bronfenbrenner’s ecological framework for human development. The programme is distributed using a train-the-trainer approach and currently implemented in 618 kindergartens. The effectiveness of this one-year intervention with an intervention and a control group will be examined in 62 kindergartens using standardised protocols, materials, and tools for outcome and process evaluation. A sample of 1021 children and their parents provided consent and participated in the intervention. Results of this study are awaited to give a better understanding of health behaviours in early childhood and to identify strategies for effective health promotion. The current paper describes development and design of the intervention and its implementation and planned evaluation. Trial Registration. The study is registered at the German Clinical Trials Register (DRKS, Freiburg University, Germany, ID: DRKS00010089.

  10. [Study of the reproducibility of the sterilization process and proposal of an sterilizer requalification protocol].

    Science.gov (United States)

    Gibory, V; Robelet, A; Riou, J; Lebelle Dehaut, A-V

    2018-03-01

    Unlike EN 554, and since the publication of ISO 17665-1 standard, the user of autoclaves may use methods other than those indicated in the guidelines. Outsourcing the requalification of sterilizers by an external service provider and after observing from the previous requalification reports that the thermometric data seemed reproducible, we decided to propose and validate a validation method for the reproducibility of the sterilization process. This is to exempt from the study of the repeatability of the EN 554 standard in future requalifications. Reproducibility was studied with the sensors of the sterilization service and from the production cycles. This study was carried out in three parts. First, we checked whether our sensors were reliable. Then we evaluated the sterilization process fidelity of each sterilizer. Finally, we compared our measurements performed by the service sensors with the measurements performed by the service provider during the requalifications of the previous years. This work leads us to describe a new protocol of requalification of our sterilizers. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

  11. Cardiovascular Risk and Its Associated Factors in Health Care Workers in Colombia: A Study Protocol.

    Science.gov (United States)

    Gamboa Delgado, Edna M; Rojas Sánchez, Lyda Z; Bermon Angarita, Anderson; Rangel Díaz, Yully Andrea; Jaraba Suárez, Silvia J; Serrano Díaz, Norma C; Vega Fernández, Evaristo

    2015-07-30

    Cardiovascular diseases are the leading cause of mortality worldwide, for this reason, they are a public health problem. In Colombia, cardiovascular diseases are the main cause of mortality, having a death rate of 152 deaths per 100,000 population. There are 80% of these cardiovascular events that are considered avoidable. The objective of the study is to determine the prevalence of the cardiovascular risk and its associated factors among the institution's workers in order to design and implement interventions in the work environment which may achieve a decrease in such risk. An analytical cross-sectional study was designed to determine the cardiovascular risk and its associated factors among workers of a high complexity health care institution. A self-applied survey will be conducted considering sociodemographic aspects, physical activity, diet, alcohol consumption, smoking, level of perceived stress, and personal and family history. In a second appointment, a physical examination will be made, as well as anthropometric measurements and blood pressure determination. Also, blood samples for evaluating total and high density lipoprotein cholesterol, triglycerides, and fasting blood sugar will be taken. A ten-year global risk for cardiovascular disease will be determined using the Framingham score. A descriptive analysis of the population's characteristics and a stratified analysis by sex, age, and occupation will be made. Bivariate and multivariate analysis will be made using logistic regression models to evaluate the association between cardiovascular risk and the independent variables. The research protocol was approved by the Scientific and Technical Committee and the Ethics Committee on Research of the Fundación Cardiovascular de Colombia. The protocol has already received funding and the enrollment phase will begin in the coming months. The results of this study will give the foundation for the design, implementation, and evaluation of a program based on

  12. Establishing a clinical phenotype for cachexia in end stage kidney disease - study protocol.

    Science.gov (United States)

    Reid, Joanne; Noble, Helen R; Adamson, Gary; Davenport, Andrew; Farrington, Ken; Fouque, Denis; Kalantar-Zadeh, Kamyar; Mallett, John; McKeaveney, C; Porter, S; Seres, David S; Shields, Joanne; Slee, Adrian; Witham, Miles D; Maxwell, Alexander P

    2018-02-13

    Surveys using traditional measures of nutritional status indicate that muscle wasting is common among persons with end-stage kidney disease (ESKD). Up to 75% of adults undergoing maintenance dialysis show some evidence of muscle wasting. ESKD is associated with an increase in inflammatory cytokines and can result in cachexia, with the loss of muscle and fat stores. At present, only limited data are available on the classification of wasting experienced by persons with ESKD. Individuals with ESKD often exhibit symptoms of anorexia, loss of lean muscle mass and altered energy expenditure. These symptoms are consistent with the syndrome of cachexia observed in other chronic diseases, such as cancer, heart failure, and acquired immune deficiency syndrome. While definitions of cachexia have been developed for some diseases, such as cardiac failure and cancer, no specific cachexia definition has been established for chronic kidney disease. The importance of developing a definition of cachexia in a population with ESKD is underscored by the negative impact that symptoms of cachexia have on quality of life and the association of cachexia with a substantially increased risk of premature mortality. The aim of this study is to determine the clinical phenotype of cachexia specific to individuals with ESKD. A longitudinal study which will recruit adult patients with ESKD receiving haemodialysis attending a Regional Nephrology Unit within the United Kingdom. Patients will be followed 2 monthly over 12 months and measurements of weight; lean muscle mass (bioelectrical impedance, mid upper arm muscle circumference and tricep skin fold thickness); muscle strength (hand held dynamometer), fatigue, anorexia and quality of life collected. We will determine if they experience (and to what degree) the known characteristics associated with cachexia. Cachexia is a debilitating condition associated with an extremely poor outcome. Definitions of cachexia in chronic illnesses are required

  13. Influence of optimizing protocol choice on the integral dose value in prostate radiotherapy planning by dynamic techniques - Pilot study.

    Science.gov (United States)

    Zaleska, Anna; Bogaczyk, Krzysztof; Piotrowski, Tomasz

    2017-01-01

    The purpose of this study was to compare the values of integral dose, calculated for treatment plans of dynamic radiotherapy techniques prepared with two different optimization protocols. Delivering radiation by IMRT, VMAT and also HT techniques has an influence on the low dose deposition of large areas of the patient body. Delivery of low dose can induce injury of healthy cells. In this situation, a good solution would be to reduce the area, which receives a low dose, but with appropriate dose level for the target volume. To calculate integral dose values of plans structures, we used 90 external beam radiotherapy plans prepared for three techniques (intensity modulated radiotherapy, volumetric modulated arc therapy and helical tomotherapy). One technique includes three different geometry combinations. 45 plans were prepared with classic optimization protocol and 45 with rings optimization protocol which should reduce the low doses in the normal tissue. Differences in values of the integral dose depend on the geometry and technique of irradiation, as well as optimization protocol used in preparing treatment plans. The application of the rings optimization caused the value of normal tissue integral dose (NTID) to decrease. It is possible to limit the area of low dose irradiation and reduce NTID in dynamic techniques with the same clinical constraints for OAR and PTV volumes by using an optimization protocol other than the classic one.

  14. Study of accent-based music speech protocol development for improving voice problems in stroke patients with mixed dysarthria.

    Science.gov (United States)

    Kim, Soo Ji; Jo, Uiri

    2013-01-01

    Based on the anatomical and functional commonality between singing and speech, various types of musical elements have been employed in music therapy research for speech rehabilitation. This study was to develop an accent-based music speech protocol to address voice problems of stroke patients with mixed dysarthria. Subjects were 6 stroke patients with mixed dysarthria and they received individual music therapy sessions. Each session was conducted for 30 minutes and 12 sessions including pre- and post-test were administered for each patient. For examining the protocol efficacy, the measures of maximum phonation time (MPT), fundamental frequency (F0), average intensity (dB), jitter, shimmer, noise to harmonics ratio (NHR), and diadochokinesis (DDK) were compared between pre and post-test and analyzed with a paired sample t-test. The results showed that the measures of MPT, F0, dB, and sequential motion rates (SMR) were significantly increased after administering the protocol. Also, there were statistically significant differences in the measures of shimmer, and alternating motion rates (AMR) of the syllable /K$\\inve$/ between pre- and post-test. The results indicated that the accent-based music speech protocol may improve speech motor coordination including respiration, phonation, articulation, resonance, and prosody of patients with dysarthria. This suggests the possibility of utilizing the music speech protocol to maximize immediate treatment effects in the course of a long-term treatment for patients with dysarthria.

  15. Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects with Metabolic Syndrome: a Double-blind Randomized Controlled Study.

    Science.gov (United States)

    Park, Byoung-Jin; Lee, Yong-Jae; Lee, Hye-Ree; Jung, Dong-Hyuk; Na, Ha-Young; Kim, Hong-Bae; Shim, Jae-Yong

    2012-07-01

    This study investigated the effects of Korean red ginseng (KRG) supplementation on metabolic parameters, inflammatory markers, and arterial stiffness in subjects with metabolic syndrome. We performed a randomized, double-blind, placebo-controlled, single-center study in 60 subjects who were not taking drugs that could affect metabolic and vascular functions. Subjects were randomized into either a KRG (4.5 g/d) group or a placebo group for a 12-week study. We collected anthropometric measurements, blood for laboratory testing, and brachial-ankle pulse wave velocity (baPWV) at the initial (week 0) and final (week 12) visits. A total of 48 subjects successfully completed the study protocol. Oral administration of KRG did not significantly affect blood pressure, oxidative or inflammatory markers, or baPWV. We found no evidence that KRG had an effect on blood pressure, lipid profile, oxidized low density lipoprotein, fasting blood glucose, or arterial stiffness in subjects with metabolic syndrome. These findings warrant subsequent longer-term prospective clinical investigations with a larger population. ClinicalTrials.gov Identifier: NCT00976274.

  16. Adherence to MRI protocol consensus guidelines in multiple sclerosis: an Australian multi-centre study

    International Nuclear Information System (INIS)

    Curley, Michael; Josey, Lawrence; Lucas, Robyn; Dear, Keith; Taylor, Bruce V.; Coulthard, Alan; Ausimmune Investigator Group

    2012-01-01

    Multiple sclerosis (MS) is a debilitating disease that causes significant morbidity within a young demographic. Diagnostic guidelines for MS have evolved, and imaging has played an increasingly important role in diagnosis over the last two decades. For imaging to contribute to diagnosis in a meaningful way, it must be reproducible. Consensus guidelines for MRI in MS exist to define correct sequence type and imaging technique, but it is not clear to what extent they are followed. This study reviewed MRI studies performed on Australian individuals presenting with a first clinical diagnosis of central nervous system demyelination (FCD) for adherence to published guidelines and discussed practical implementation of MS guidelines in light of recent updates. The Ausimmune study was a prospective case control study of Australian participants presenting with FCD from 2003 to 2006. Baseline cranial and spinal cord MRI studies of 226 case participants from four separate Australian regions were reviewed. MRI sequences were classified according to anatomical location, slice plane, tissue weighting and use of gadolinium-containing contrast media. Results were compared with the 2003 Consortium of Multiple Sclerosis Centres MRI protocol for the diagnosis of MS. The composition of core cranial MRI sequences performed varied across the 226 scans. Of the studies, 91% included sagittal fluid attenuated inversion recovery (FLAIR) sequences. Cranial axial T2-weighted, axial FLAIR and axial proton density-weighted sequences were performed in 88%, 60% and 16% (respectively) of scans. Only 25% of the studies included a T1-weighted contrast-enhanced sequence. Concordance with the guidelines in all sequences was very low (2). Only a small number of MRI investigations performed included all of the sequences stipulated by consensus guidelines. This is likely due to poor awareness in the imaging community of the guidelines and the rationale behind certain sequences. Radiologists with a sub

  17. Brazilian Samba Protocol for Individuals With Parkinson’s Disease: A Clinical Non-Randomized Study

    Science.gov (United States)

    2017-01-01

    Background In the 10 most populated countries in the world, Parkinson's disease (PD) affects more than 5 million individuals. Despite optimal treatment options already developed for the disease, concomitant involvement of other areas of health care plays an important role in complementing the treatment. From this perspective, dancing can be viewed as a non-drug alternative that can reduce falls by improving some motor skills, such as mobility, balance, gait, and posture, and can also improve the overall quality of life. Brazilian samba promotes improvement in motor and non-motor symptoms in individuals with PD, providing a new treatment option for this population. Objective The main objective of this quasi-experimental study is to provide a 12-week samba protocol (2x/week) for individuals with PD and to compare its effects with the group without intervention. The hypothesis is that the Brazilian samba protocol will promote improvement in primary (motor) and secondary (non-motor) outcomes in individuals with PD. Methods The sample will be selected at random from individuals diagnosed with PD in the city of Florianopolis (SC, Brazil). Sample size calculation was performed with the G*Power 3.1.9.2 software, with 0.447 effect size, at 5% significance level, power of 0.9, and test and sample loss of 20%. This yielded 60 individuals divided between the intervention and control groups. The questionnaires will be filled out before and after the dance intervention. The data collection for the control group will be held simultaneously to the intervention group. The classes will last for 1 hour, twice a week in the evening for 12 weeks, and all classes will be divided into warm-up, main part, and relaxation. Two-way analysis of variance with repeated measures and Sidak post-hoc comparison test will be used for a comparative analysis of the final results of the control group with the experimental group and of the within-group changes between pre- and postintervention period

  18. A protocol for isolating insect mitochondrial genomes: a case study of NUMT in Melipona flavolineata (Hymenoptera: Apidae).

    Science.gov (United States)

    Françoso, Elaine; Gomes, Fernando; Arias, Maria Cristina

    2016-07-01

    Nuclear mitochondrial DNA insertions (NUMTs) are mitochondrial DNA sequences that have been transferred into the nucleus and are recognized by the presence of indels and stop codons. Although NUMTs have been identified in a diverse range of species, their discovery was frequently accidental. Here, our initial goal was to develop and standardize a simple method for isolating NUMTs from the nuclear genome of a single bee. Subsequently, we tested our new protocol by determining whether the indels and stop codons of the cytochrome c oxidase subunit I (COI) sequence of Melipona flavolineata are of nuclear origin. The new protocol successfully demonstrated the presence of a COI NUMT. In addition to NUMT investigations, the protocol described here will also be very useful for studying mitochondrial mutations related to diseases and for sequencing complete mitochondrial genomes with high read coverage by Next-Generation technology.

  19. Bio-repository of DNA in stroke: a study protocol of three ancestral populations

    Directory of Open Access Journals (Sweden)

    Ioana Cotlarciuc

    2012-07-01

    Full Text Available Stroke is a leading cause of death and disability in the world. Identifying the genes underlying stroke risk may help us to improve our understanding of the mechanisms that cause stroke and also identify novel therapeutic targets. To have sufficient power to disentangle the genetic component of stroke, large-scale highly phenotyped DNA repositories are necessary. The BRAINS (Bio-repository of DNA in stroke study aims to recruit subjects with all subtypes of stroke as well as controls from UK, India, Sri Lanka and Qatar. BRAINS-UK will include 1500 stroke patients of European ancestry as well as British South Asians. BRAINS-South Asia aims to recruit 3000 stroke subjects and 3000 controls from across India and Sri Lanka. BRAINS-Middle East aims to enrol 1500 stroke patients from Qatar. The controls for BRAINS-Middle East will be recruited from a population-based Qatari Biobank. With the addition of new recruitment centres in India and Qatar, we present an updated version of the BRAINS study protocol. This is the first international DNA biobank for stroke patients and controls from the Middle East. By investigating the influence of genetic factors on stroke risk in European, South Asian and Middle Eastern populations, BRAINS has the potential to improve our understanding of genetic differences between these groups and may lead to new population-specific therapeutic targets.

  20. Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jimin Park

    2015-01-01

    Full Text Available Background. Atrial fibrillation (AF is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF. Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA and left atrial appendage (LAA changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs of Kyung Hee University Hospital (number 1335-04. This trial is registered with clinicaltrials.gov NCT02110537.

  1. Methodological Study to Develop Standard Operational Protocol on Oral Drug Administration for Children.

    Science.gov (United States)

    Bijarania, Sunil Kumar; Saini, Sushma Kumari; Verma, Sanjay; Kaur, Sukhwinder

    2017-05-01

    To develop standard operational protocol (SOP) on oral drug administration and checklist to assess the implementation of the developed SOP. In this prospective methodological study, SOPs were developed in five phases. In the first phase, the preliminary draft of SOPs and checklists were prepared based on literature review, assessment of current practices and focus group discussion (FGD) with bedside working nurses. In the second phase, content validity was checked with the help of Delphi technique (12 experts). Total four drafts were prepared in stages and necessary modifications were made as per suggestions after each Delphi round. Fourth Delphi round was performed after conducting a pilot study. In the fourth phase, all bedside nurses were trained as per SOPs and asked to practice accordingly and observation of thirty oral drug administrations in children was done to check reliability of checklists for implementation of SOPs. In Phase-V, 7 FGDs were conducted with bedside nurses to assess the effectiveness of SOPs. The Content Validity Index (CVI) of SOP and checklists was 99.77%. Overall standardized Cronbach's alpha was calculated as 0.94. All the nurses felt that the SOP is useful. Valid and feasible SOP for drug administration to children through oral route along with valid and reliable checklist were developed. It is recommended to use this document for drug administration to children.

  2. New finite element study protocol: Clinical simulation of orthodontic tooth movement.

    Science.gov (United States)

    Bouton, Antoine; Simon, Yohann; Goussard, Florent; Teresi, Luciano; Sansalone, Vittorio

    2017-06-01

    The aim of this work was to model tooth movement in a more clinically-exact fashion, thanks to the use of new IT tools and imaging systems (cone-beam). Image segmentation and 3D reconstruction now enable us to model the anatomy realistically, while finite element (FE) analysis makes it possible to evaluate stresses and their distribution on the level of the tooth, the periodontal ligament (PDL) and the alveolar bone when a force is applied. The principle is to monitor tooth movement by obtaining optical impressions at each stage of treatment. The model corresponds to a genuine clinical situation. FE analysis is correlated with the clinically-observed displacement. The protocol remains long and complex. It nevertheless makes it possible to obtain, throughout the duration of treatment, patient-specific models that can be exploited using finite element methods. It requires further validation in more thorough studies but offers interesting prospects: precise study of induced tooth movement, distribution of stresses in the PDL, and development of a customized previsualization tool. Copyright © 2017. Published by Elsevier Masson SAS.

  3. [Validation of the Italian Clinical Learning Environment Instrument (SVIAT):study protocol].

    Science.gov (United States)

    Palese, Alvisa; Destrebecq, Anne; Terzoni, Stefano; Grassetti, Luca; Altini, Pietro; Bevilacqua, Anita; Brugnolli, Anna; Benaglio, Carla; Dalponte, Adriana; De Biasio, Laura; Dimonte, Valerio; Gambacorti, Benedetta; Fasci, Adriana; Grosso, Silvia; Mansutti, Irene; Mantovan, Franco; Marognolli, Oliva; Montalti, Sandra; Nicotera, Raffaela; Perli, Serena; Randon, Giulia; Stampfl, Brigitte; Tollini, Morena; Canzan, Federica; Zannini, Lucia; Saiani, Luisa

    2016-01-01

    . Validation of the Italian Clinical Learning Environment Instrument (SVIAT): study protocol. Nursing students obtain most of their university credits in internship environments whose quality can affect their clinical learning. Several tools are available to measure the quality of the clinical learning environment (CLE) as perceived by students: these instruments developed in other countries, were validated in Italian but do not discriminate those CLEs capable (or not) to promote significant clinical learning. To validate an instrument to measure the capability of the CLE to generate clinical learning; the secondary aim is to describe the learning environments as perceived by nursing students according to individual course site and tutorial models adopted. The study will be developed in three phases: a) instrument development and pilot phase, b) validation of the psychometric properties of the instrument and c) description of the CLEs as perceived by the students including factors/item confirmed in the validation process. Expected outcomes. A large validation, with more than 8,000 participating students is expected; the construct under lying will be confirmed through exploratory and confirmatory factor analysis and will report high internal consistency; the instrument will report also a high test-retest and inter-rater reliability; in addition, the instrument will demonstrate predictive ability by discriminating those units able (or not) to activate effective learning processes.

  4. Methylene blue for postcardiopulmonary bypass vasoplegic syndrome: A cohort study

    Directory of Open Access Journals (Sweden)

    Michael Mazzeffi

    2017-01-01

    Full Text Available Background: Methylene blue (MB has been used to treat refractory hypotension in a variety of settings. Aims: We sought to determine whether MB improved blood pressure in postcardiopulmonary bypass (CPB vasoplegic syndrome (VS in a complex cardiac surgery population. Furthermore, to determine variables that predicted response to MB. Setting and Design: This was conducted in a tertiary care medical center; this study was a retrospective cohort study. Materials and Methods: Adult cardiac surgery patients who received MB for post-CPB VS over a 2-year period were studied. Mean arterial blood pressure (MAP and vasopressor doses were compared before and after MB, and logistic regression was used to model which variables predicted response. Results: Eighty-eight patients received MB for post-CPB VS during the study period. MB administration was associated with an 8 mmHg increase in MAP (P = 0.004, and peak response occurred at 2 h. Variables that were associated with a positive drug response were deep hypothermic circulatory arrest during surgery and higher MAP at the time of drug administration (P = 0.006 and 0.02. A positive response had no correlation with in-hospital mortality (P = 0.09. Conclusions: MB modestly increases MAP in cardiac surgery patients with VS. Higher MAP at the time of drug administration and surgery with deep hypothermic circulatory arrest predict a greater drug response.

  5. A study protocol to evaluate the relationship between outdoor air pollution and pregnancy outcomes.

    Science.gov (United States)

    Ribeiro, Manuel C; Pereira, Maria J; Soares, Amílcar; Branquinho, Cristina; Augusto, Sofia; Llop, Esteve; Fonseca, Susana; Nave, Joaquim G; Tavares, António B; Dias, Carlos M; Silva, Ana; Selemane, Ismael; de Toro, Joaquin; Santos, Mário J; Santos, Fernanda

    2010-10-15

    The present study protocol is designed to assess the relationship between outdoor air pollution and low birth weight and preterm births outcomes performing a semi-ecological analysis. Semi-ecological design studies are widely used to assess effects of air pollution in humans. In this type of analysis, health outcomes and covariates are measured in individuals and exposure assignments are usually based on air quality monitor stations. Therefore, estimating individual exposures are one of the major challenges when investigating these relationships with a semi-ecologic design. Semi-ecologic study consisting of a retrospective cohort study with ecologic assignment of exposure is applied. Health outcomes and covariates are collected at Primary Health Care Center. Data from pregnant registry, clinical record and specific questionnaire administered orally to the mothers of children born in period 2007-2010 in Portuguese Alentejo Litoral region, are collected by the research team. Outdoor air pollution data are collected with a lichen diversity biomonitoring program, and individual pregnancy exposures are assessed with spatial geostatistical simulation, which provides the basis for uncertainty analysis of individual exposures. Awareness of outdoor air pollution uncertainty will improve validity of individual exposures assignments for further statistical analysis with multivariate regression models. Exposure misclassification is an issue of concern in semi-ecological design. In this study, personal exposures are assigned to each pregnant using geocoded addresses data. A stochastic simulation method is applied to lichen diversity values index measured at biomonitoring survey locations, in order to assess spatial uncertainty of lichen diversity value index at each geocoded address. These methods assume a model for spatial autocorrelation of exposure and provide a distribution of exposures in each study location. We believe that variability of simulated exposure values at

  6. Early signaling, referral, and treatment of adolescent chronic pain: a study protocol

    Directory of Open Access Journals (Sweden)

    Voerman Jessica S

    2012-06-01

    Full Text Available Abstract Background Chronic pain is prevalent among young people and negatively influences their quality of life. Furthermore, chronic pain in adolescence may persist into adulthood. Therefore, it is important early on to promote the self-management skills of adolescents with chronic pain by improving signaling, referral, and treatment of these youngsters. In this study protocol we describe the designs of two complementary studies: a signaling study and an intervention study. Methods and design The signaling study evaluates the Pain Barometer, a self-assessed signaling instrument for chronic pain in adolescents. To evaluate the feasibility of the Pain Barometer, the experiences of youth-health care nurses will be evaluated in semi-structured interviews. Also, we will explore the frequencies of referral per health-care provider. The intervention study evaluates Move It Now, a guided self-help intervention via the Internet for teenagers with chronic pain. This intervention uses cognitive behavioural techniques, including relaxation exercises and positive thinking. The objective of the intervention is to improve the ability of adolescents to cope with pain. The efficacy of Move It Now will be examined in a randomized controlled trial, in which 60 adolescents will be randomly assigned to an experimental condition or a waiting list control condition. Discussion If the Pain Barometer is proven to be feasible and Move It Now appears to be efficacious, a health care pathway can be created to provide the best tailored treatment promptly to adolescents with chronic pain. Move It Now can be easily implemented throughout the Netherlands, as the intervention is Internet based. Trial registration Dutch Trial Register NTR1926

  7. A study protocol to evaluate the relationship between outdoor air pollution and pregnancy outcomes

    Directory of Open Access Journals (Sweden)

    Selemane Ismael

    2010-10-01

    Full Text Available Abstract Background The present study protocol is designed to assess the relationship between outdoor air pollution and low birth weight and preterm births outcomes performing a semi-ecological analysis. Semi-ecological design studies are widely used to assess effects of air pollution in humans. In this type of analysis, health outcomes and covariates are measured in individuals and exposure assignments are usually based on air quality monitor stations. Therefore, estimating individual exposures are one of the major challenges when investigating these relationships with a semi-ecologic design. Methods/Design Semi-ecologic study consisting of a retrospective cohort study with ecologic assignment of exposure is applied. Health outcomes and covariates are collected at Primary Health Care Center. Data from pregnant registry, clinical record and specific questionnaire administered orally to the mothers of children born in period 2007-2010 in Portuguese Alentejo Litoral region, are collected by the research team. Outdoor air pollution data are collected with a lichen diversity biomonitoring program, and individual pregnancy exposures are assessed with spatial geostatistical simulation, which provides the basis for uncertainty analysis of individual exposures. Awareness of outdoor air pollution uncertainty will improve validity of individual exposures assignments for further statistical analysis with multivariate regression models. Discussion Exposure misclassification is an issue of concern in semi-ecological design. In this study, personal exposures are assigned to each pregnant using geocoded addresses data. A stochastic simulation method is applied to lichen diversity values index measured at biomonitoring survey locations, in order to assess spatial uncertainty of lichen diversity value index at each geocoded address. These methods assume a model for spatial autocorrelation of exposure and provide a distribution of exposures in each study location

  8. Optimal Scanning Protocols for Dual-Energy CT Angiography in Peripheral Arterial Stents: An in Vitro Phantom Study

    Directory of Open Access Journals (Sweden)

    Abdulrahman Almutairi

    2015-05-01

    Full Text Available Objective: To identify the optimal dual-energy computed tomography (DECT scanning protocol for peripheral arterial stents while achieving a low radiation dose, while still maintaining diagnostic image quality, as determined by an in vitro phantom study. Methods: Dual-energy scans in monochromatic spectral imaging mode were performed on a peripheral arterial phantom with use of three gemstone spectral imaging (GSI protocols, three pitch values, and four kiloelectron volts (keV ranges. A total of 15 stents of different sizes, materials, and designs were deployed in the phantom. Image noise, the signal-to-noise ratio (SNR, different levels of adaptive statistical iterative reconstruction (ASIR, and the four levels of monochromatic energy for DECT imaging of peripheral arterial stents were measured and compared to determine the optimal protocols. Results: A total of 36 scans with 180 datasets were reconstructed from a combination of different protocols. There was a significant reduction of image noise with a higher SNR from monochromatic energy images between 65 and 70 keV in all investigated preset GSI protocols (p < 0.05. In addition, significant effects were found from the main effect analysis for these factors: GSI, pitch, and keV (p = 0.001. In contrast, there was significant interaction on the unstented area between GSI and ASIR (p = 0.015 and a very high significant difference between keV and ASIR (p < 0.001. A radiation dose reduction of 50% was achieved. Conclusions: The optimal scanning protocol and energy level in the phantom study were GSI-48, pitch value 0.984, and 65 keV, which resulted in lower image noise and a lower radiation dose, but with acceptable diagnostic images.

  9. MyVoice National Text Message Survey of Youth Aged 14 to 24 Years: Study Protocol.

    Science.gov (United States)

    DeJonckheere, Melissa; Nichols, Lauren P; Moniz, Michelle H; Sonneville, Kendrin R; Vydiswaran, V G Vinod; Zhao, Xinyan; Guetterman, Timothy C; Chang, Tammy

    2017-12-11

    There has been little progress in adolescent health outcomes in recent decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health care policy. Our aim is to describe the protocol of the MyVoice Project, a longitudinal mixed methods study designed to engage youth, particularly those not typically included in research. Text messaging surveys are collected, analyzed, and disseminated in real time to leverage youth perspectives to impact policy. Youth aged 14 to 24 years are recruited to receive weekly text message surveys on a variety of policy and health topics. The research team, including academic researchers, methodologists, and youth, develop questions through an iterative writing and piloting process. Question topics are elicited from community organizations, researchers, and policy makers to inform salient policies. A youth-centered interactive platform has been developed that automatically sends confidential weekly surveys and incentives to participants. Parental consent is not required because the survey is of minimal risk to participants. Recruitment occurs online (eg, Facebook, Instagram, university health research website) and in person at community events. Weekly surveys collect both quantitative and qualitative data. Quantitative data are analyzed using descriptive statistics. Qualitative data are quickly analyzed using natural language processing and traditional qualitative methods. Mixed methods integration and analysis supports a more in-depth understanding of the research questions. We are currently recruiting and enrolling participants through in-person and online strategies. Question development, weekly data collection, data analysis, and dissemination are in progress. MyVoice quickly ascertains the thoughts and opinions of youth in real time using a widespread, readily available technology-text messaging. Results are disseminated to researchers, policy makers, and

  10. Acupuncture, Counseling, and Usual care for Depression (ACUDep: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MacPherson Hugh

    2012-11-01

    Full Text Available Abstract Background The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. Methods/Design Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. Participants: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II. Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. Interventions: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. Outcome: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. Analysis: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. Analysis of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will

  11. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study.

    Science.gov (United States)

    Quanbeck, Andrew R; Gustafson, David H; Marsch, Lisa A; McTavish, Fiona; Brown, Randall T; Mares, Marie-Louise; Johnson, Roberta; Glass, Joseph E; Atwood, Amy K; McDowell, Helene

    2014-05-29

    Healthcare reform in the United States is encouraging Federally Qualified Health Centers and other primary-care practices to integrate treatment for addiction and other behavioral health conditions into their practices. The potential of mobile health technologies to manage addiction and comorbidities such as HIV in these settings is substantial but largely untested. This paper describes a protocol to evaluate the implementation of an E-Health integrated communication technology delivered via mobile phones, called Seva, into primary-care settings. Seva is an evidence-based system of addiction treatment and recovery support for patients and real-time caseload monitoring for clinicians. Our implementation strategy uses three models of organizational change: the Program Planning Model to promote acceptance and sustainability, the NIATx quality improvement model to create a welcoming environment for change, and Rogers's diffusion of innovations research, which facilitates adaptations of innovations to maximize their adoption potential. We will implement Seva and conduct an intensive, mixed-methods assessment at three diverse Federally Qualified Healthcare Centers in the United States. Our non-concurrent multiple-baseline design includes three periods - pretest (ending in four months of implementation preparation), active Seva implementation, and maintenance - with implementation staggered at six-month intervals across sites. The first site will serve as a pilot clinic. We will track the timing of intervention elements and assess study outcomes within each dimension of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, including effects on clinicians, patients, and practices. Our mixed-methods approach will include quantitative (e.g., interrupted time-series analysis of treatment attendance, with clinics as the unit of analysis) and qualitative (e.g., staff interviews regarding adaptations to implementation protocol) methods, and assessment of

  12. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ubbink Dirk T

    2011-10-01

    Full Text Available Abstract Background Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. Methods A 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale. Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009. Discussion This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such

  13. Magnitude and management of metabolic syndrome in Spain in 2008-2010: the ENRICA study.

    Science.gov (United States)

    Guallar-Castillón, Pilar; Pérez, Raúl Francisco; López García, Esther; León-Muñoz, Luz M; Aguilera, M Teresa; Graciani, Auxiliadora; Gutiérrez-Fisac, Juan Luis; Banegas, José R; Rodríguez-Artalejo, Fernando

    2014-05-01

    Few studies in Spain have reported the distribution of metabolic syndrome using the harmonized definition and that of premorbid metabolic syndrome, which consists of metabolic syndrome without diabetes mellitus or cardiovascular disease. Moreover, their regional distributions and clinical management are unknown. The present study examined the distributions and clinical management of both syndromes in Spain. This cross-sectional study was performed from 2008 to 2010 in 11 149 representative individuals of the Spanish population aged 18 years or older. Data were obtained through standardized physical examination, and analytical measurements were done in a central laboratory. The prevalences (95% confidence interval) of metabolic syndrome and premorbid metabolic syndrome were 22.7% (21.7%-23.7%) and 16.9% (16.0%-17.8%), respectively. The frequency of both syndromes increased with age and was higher in men than in women up to 65 years; above this age, the frequency was higher in women. The communities of the south of Spain and the Balearic and Canary islands had the highest prevalence of both syndromes, in some regions reaching double that of the community with the lowest prevalence. About one third of patients with premorbid metabolic syndrome reported that they had not received health recommendations to improve their lifestyles; of those that did receive advice, adherence was low, particularly for reducing weight (31.9%) and salt intake (38.3%). The prevalence of metabolic syndrome is high in Spain and considerable geographical differences exist in its distribution. There is substantial room for improvement in the clinical management of premorbid metabolic syndrome. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  14. A Pooled Genome-Wide Association Study of Asperger Syndrome.

    Directory of Open Access Journals (Sweden)

    Varun Warrier

    Full Text Available Asperger Syndrome (AS is a neurodevelopmental condition characterized by impairments in social interaction and communication, alongside the presence of unusually repetitive, restricted interests and stereotyped behaviour. Individuals with AS have no delay in cognitive and language development. It is a subset of Autism Spectrum Conditions (ASC, which are highly heritable and has a population prevalence of approximately 1%. Few studies have investigated the genetic basis of AS. To address this gap in the literature, we performed a genome-wide pooled DNA association study to identify candidate loci in 612 individuals (294 cases and 318 controls of Caucasian ancestry, using the Affymetrix GeneChip Human Mapping version 6.0 array. We identified 11 SNPs that had a p-value below 1x10-5. These SNPs were independently genotyped in the same sample. Three of the SNPs (rs1268055, rs7785891 and rs2782448 were nominally significant, though none remained significant after Bonferroni correction. Two of our top three SNPs (rs7785891 and rs2782448 lie in loci previously implicated in ASC. However, investigation of the three SNPs in the ASC genome-wide association dataset from the Psychiatric Genomics Consortium indicated that these three SNPs were not significantly associated with ASC. The effect sizes of the variants were modest, indicating that our study was not sufficiently powered to identify causal variants with precision.

  15. Complex regional pain syndrome 1 – the Swiss cohort study

    Directory of Open Access Journals (Sweden)

    Perez Roberto SGM

    2008-06-01

    Full Text Available Abstract Background Little is known about the course of Complex Regional Pain Syndrome 1 and potential factors influencing the course of this disorder over time. The goal of this study is a to set up a database with patients suffering from suspected CRPS 1 in an initial stadium, b to perform investigations on epidemiology, diagnosis, prognosis, and socioeconomics within the database and c to develop a prognostic risk assessment tool for patients with CRPS 1 taking into account symptomatology and specific therapies. Methods/design Prospective cohort study. Patients suffering from a painful swelling of the hand or foot which appeared within 8 weeks after a trauma or a surgery and which cannot be explained by conditions that would otherwise account for the degree of pain and dysfunction will be included. In accordance with the recommendations of International Classification of Functioning, Disability and Health (ICF model, standardised and validated questionnaires will be used. Patients will be monitored over a period of 2 years at 6 scheduled visits (0 and 6 weeks, 3, 6, 12, and 24 months. Each visit involves a physical examination, registration of therapeutic interventions, and completion of the various study questionnaires. Outcomes involve changes in health status, quality of life and costs/utility. Discussion This paper describes the rationale and design of patients with CRPS 1. Ideally, potential risk factors may be identified at an early stage in order to initiate an early and adequate treatment in patients with increased risk for delayed recovery. Trial registration Not applicable

  16. A Pooled Genome-Wide Association Study of Asperger Syndrome.

    Science.gov (United States)

    Warrier, Varun; Chakrabarti, Bhismadev; Murphy, Laura; Chan, Allen; Craig, Ian; Mallya, Uma; Lakatošová, Silvia; Rehnstrom, Karola; Peltonen, Leena; Wheelwright, Sally; Allison, Carrie; Fisher, Simon E; Baron-Cohen, Simon

    2015-01-01

    Asperger Syndrome (AS) is a neurodevelopmental condition characterized by impairments in social interaction and communication, alongside the presence of unusually repetitive, restricted interests and stereotyped behaviour. Individuals with AS have no delay in cognitive and language development. It is a subset of Autism Spectrum Conditions (ASC), which are highly heritable and has a population prevalence of approximately 1%. Few studies have investigated the genetic basis of AS. To address this gap in the literature, we performed a genome-wide pooled DNA association study to identify candidate loci in 612 individuals (294 cases and 318 controls) of Caucasian ancestry, using the Affymetrix GeneChip Human Mapping version 6.0 array. We identified 11 SNPs that had a p-value below 1x10-5. These SNPs were independently genotyped in the same sample. Three of the SNPs (rs1268055, rs7785891 and rs2782448) were nominally significant, though none remained significant after Bonferroni correction. Two of our top three SNPs (rs7785891 and rs2782448) lie in loci previously implicated in ASC. However, investigation of the three SNPs in the ASC genome-wide association dataset from the Psychiatric Genomics Consortium indicated that these three SNPs were not significantly associated with ASC. The effect sizes of the variants were modest, indicating that our study was not sufficiently powered to identify causal variants with precision.

  17. STX1A and Asperger syndrome: a replication study.

    Science.gov (United States)

    Durdiaková, Jaroslava; Warrier, Varun; Banerjee-Basu, Sharmila; Baron-Cohen, Simon; Chakrabarti, Bhismadev

    2014-02-18

    Autism spectrum conditions (ASC) are a group of conditions characterized by difficulties in communication and social interaction, alongside unusually narrow interests and repetitive, stereotyped behaviour. Genetic association and expression studies have suggested an important role for the GABAergic circuits in ASC. Syntaxin 1A (STX1A) encodes a protein involved in regulation of serotonergic and GABAergic systems and its expression is altered in autism. In this study, the association between three single nucleotide polymorphisms (SNPs) (rs4717806, rs941298 and rs6951030) in STX1A gene and Asperger syndrome (AS) were tested in 650 controls and 479 individuals with AS, all of Caucasian ancestry. rs4717806 (P = 0.00334) and rs941298 (P = 0.01741) showed a significant association with AS, replicating previous results. Both SNPs putatively alter transcription factor binding sites both directly and through other variants in high linkage disequilibrium. The current study confirms the role of STX1A as an important candidate gene in ASC. The exact molecular mechanisms through which STX1A contributes to the etiology remain to be elucidated.

  18. [Ogilvie syndrome in the elderly: retrospective study of 40 cases].

    Science.gov (United States)

    Fraisse, Adeline; Brosse, Sophie; Manckoundia, Patrick; Popitéan, Laura; Pfitzenmeyer, Pierre

    2003-10-04

    To assess, in a population of elderly patients, the circumstances clinical and progressive characteristics and form of management of an acute colonic pseudo-obstruction (ACPO). Retrospective study of the files of 40 patients aged 70 and more having presented an acute colonic pseudo-obstruction and hospitalised in the university hospital in Dijon from January 1995 to June 2000. The population was composed of 24 men (60%) and 16 women (40%) with a mean age of 80.8 years. The reasons for hospitalisation were varied: only 15 patients had been referred for an occlusive syndrome. 39 patients presented with abdominal distension, 30 suffered from abdominal pain. In this population, 17 patients exhibited reduced or clearly limited mobility, 20 patients had altered cognitive capacity with an MMS colon aspiration was performed in 20 patients and molecules to improve peristaltism were administered in 21 cases, with neostigmine prescribed for 9 patients. Surgery was required for 7 patients and 3 of them subsequently died. In terms of progression, 20 patients were cured after treatment, 13 relapsed and 7 patients worsened. Unfortunately, 10 patients died in our series. In our study, the clinical profiles of acute colonic pseudo-obstruction were similar to those described in the literature: they occurred in varying circumstances, in medical or surgical settings ina predominantly male population of elderly, heavily dependent,patients. Treatment of this affection is not clearly codified for fragile patients with multiple diseases and the mortality rate observed should stimulate further studies, notably on pharmacological level.

  19. Oculomotor neurocircuitry, a structural connectivity study of infantile nystagmus syndrome.

    Directory of Open Access Journals (Sweden)

    Nasser H Kashou

    Full Text Available Infantile nystagmus syndrome (INS is one of the leading causes of significant vision loss in children and affects about 1 in 1000 to 6000 births. In the present study, we are the first to investigate the structural pathways of patients and controls using diffusion tensor imaging (DTI. Specifically, three female INS patients from the same family were scanned, two sisters and a mother. Six regions of interest (ROIs were created manually to analyze the number of tracks. Additionally, three ROI masks were analyzed using TBSS (Tract-Based Spatial Statistics. The number of fiber tracks was reduced in INS subjects, compared to normal subjects, by 15.9%, 13.9%, 9.2%, 18.6%, 5.3%, and 2.5% for the pons, cerebellum (right and left, brainstem, cerebrum, and thalamus. Furthermore, TBSS results indicated that the fractional anisotropy (FA values for the patients were lower in the superior ventral aspects of the pons of the brainstem than in those of the controls. We have identified some brain regions that may be actively involved in INS. These novel findings would be beneficial to the neuroimaging clinical and research community as they will give them new direction in further pursuing neurological studies related to oculomotor function and provide a rational approach to studying INS.

  20. Grammatical Constructions in Cri du Chat Syndrome--Findings from a Case Study

    Science.gov (United States)

    Kristoffersen, Kristian Emil

    2009-01-01

    The literature on grammatical skills in persons with Cri du chat syndrome (CCS) is very limited, and the need for more knowledge in this area is thus evident, in particular for speech and language therapists working with individuals with this syndrome. This case study report describes the syntactic skills of a 14-year-old Norwegian girl with CCS.…

  1. A Longitudinal Study of Narrative Development in Children and Adolescents with Down Syndrome

    Science.gov (United States)

    Cleave, Patricia; Bird, Elizabeth Kay-Raining; Czutrin, Rachael; Smith, Lindsey

    2012-01-01

    The present study examined narrative development in children and adolescents with Down syndrome longitudinally. Narratives were collected from 32 children and adolescents with Down syndrome three times over a 1-year period. Both micro- and macrolevel analyses were conducted. Significant growth over the 1-year period was seen in semantic complexity…

  2. Pregnancy and aortic root growth in the Marfan syndrome: a prospective study

    NARCIS (Netherlands)

    Meijboom, Lilian J.; Vos, Frederiek E.; Timmermans, Janneke; Boers, Godfried H.; Zwinderman, Aeiko H.; Mulder, Barbara J. M.

    2005-01-01

    Aims In women with Marfan syndrome pregnancy presents an increased risk of dilatation, dissection, and rupture of the aorta. The aim of this study was to investigate the influence of pregnancy on growth of the aortic root. Methods and results Between 1993 and 2004 127 women with Marfan syndrome were

  3. Pregnancy and aortic root growth in the Marfan syndrome: a prospective study.

    NARCIS (Netherlands)

    Meijboom, L.J.; Vos, F.E.; Timmermans, J.; Boers, G.H.J.; Zwinderman, A.H.; Mulder, B.J.M.

    2005-01-01

    AIMS: In women with Marfan syndrome pregnancy presents an increased risk of dilatation, dissection, and rupture of the aorta. The aim of this study was to investigate the influence of pregnancy on growth of the aortic root. METHODS AND RESULTS: Between 1993 and 2004 127 women with Marfan syndrome

  4. Denervation of the renal arteries in metabolic syndrome : The DREAMS-study

    NARCIS (Netherlands)

    Verloop, WL; Spiering, Wilko; Vink, Eva E.; Beeftink, Martine M A; Blankestijn, Peter J.; Doevendans, Pieter A.; Voskuil, Michiel

    2015-01-01

    Chronic elevation of sympathetic nervous system is a key factor in metabolic syndrome. Because renal denervation (RDN) is thought to modulate sympathetic activity, we performed the Denervation of the Renal Arteries in Metabolic Syndrome (DREAMS)-study to investigate the effects of RDN on insulin

  5. Study of Different Social Rewards Used in Down's Syndrome Children's Early Stimulation

    Science.gov (United States)

    Sanz, Teresa; Menendez, Javier; Rosique, Teresa

    2011-01-01

    This article describes the results obtained with two types of social rewards used in early stimulation of Down's syndrome children. In the study we focus on the efficiency of the employment of the social rewards or reinforcements used in the early stimulation, bearing in mind that the children with Down's syndrome possess a social development…

  6. Dental development in Down syndrome and healthy children: a comparative study using the Demirjian method.

    NARCIS (Netherlands)

    Linden, M.S. van der; Vucic, S.; Marrewijk, D.J.F. van; Ongkosuwito, E.M.

    2017-01-01

    OBJECTIVE: In children with Down syndrome, the timing of dental eruption is important for orthodontics treatment planning. Aim of this study was to determine whether tooth eruption and development of the dentition in children with Down syndrome are impaired. MATERIAL AND METHODS: Dental development

  7. Prevalence of metabolic syndrome in Chinese psoriasis patients: A hospital-based cross-sectional study.

    Science.gov (United States)

    Gui, Xin-Yu; Yu, Xiao-Ling; Jin, Hong-Zhong; Zuo, Ya-Gang; Wu, Chao

    2018-01-01

    Psoriasis, a chronic autoimmune skin disorder, is believed to contribute to cardiovascular diseases and metabolic syndrome. Psoriasis's association with the components of metabolic syndrome has been reported previously. However, large-scale cross-sectional studies about psoriasis and metabolic syndrome are rare in China. We assessed the prevalence of metabolic syndrome in Chinese psoriasis patients and controls. A total of 859 psoriasis patients and 1,718 controls were recruited in an age- and sex-matched cross-sectional study. Metabolic syndrome occurred in 14.3% of the psoriasis patients as opposed to 10.0% of the control participants (P = 0.001). Psoriasis patients had a higher prevalence of overweight/obesity, hyperglycemia and dyslipidemia when compared with controls. Meanwhile, psoriasis patients with metabolic syndrome were older, and had an older age of onset and a longer disease duration when compared with those without metabolic syndrome. The prevalence of metabolic syndrome is higher in the Chinese psoriatic population, which can favor cardiovascular events. The present study strengthens the value of treating psoriasis patients not only dealing with the skin lesions, and we suggest appropriate screening and relevant health education be carried out in the treatment of psoriasis patients. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  8. A study of new potential risk factors for Down syndrome in Upper Egypt

    African Journals Online (AJOL)

    Down syndrome is a common chromosomal anomaly causing multiple congenital malformations and mental retardation (MR) in humans. The well-established risk factor, advanced maternal age, was not found in many of the Down syndrome cases in Egypt, while other possible risk factors have not been well studied yet.

  9. Antipsychotic Polypharmacy and Its Relation to Metabolic Syndrome in Patients With Schizophrenia: An Egyptian Study.

    Science.gov (United States)

    Aly El-Gabry, Dina M; Abdel Aziz, Karim; Okasha, Tarek; Azzam, Hanan; Okasha, Ahmed

    2018-02-01

    Few studies have examined the relationship between antipsychotic polypharmacy and metabolic syndrome in schizophrenia. Some studies suggest that antipsychotic polypharmacy may be associated with greater metabolic risk, whereas other studies suggest that this is uncertain. To date, there have been no studies in Egypt or the Arab world that have investigated this relationship. We sought to compare subjects with schizophrenia receiving antipsychotic polypharmacy and monotherapy as regards metabolic outcomes and to investigate medication-related factors associated with metabolic syndrome. We recruited 118 subjects with schizophrenia and compared between those receiving antipsychotic polypharmacy (86 subjects) and monotherapy (32 subjects) as regards demographic, clinical, metabolic, and antipsychotic medication characteristics. We examined the effect of antipsychotic-related factors an outcome of metabolic syndrome. The prevalence of metabolic syndrome in our sample was 38.1%. Except for gender, there was no statistically significant difference as regards demographic and clinical characteristics, rates of metabolic syndrome, or for individual metabolic parameters. We found a statistically significant difference (P antipsychotics (oral and depot) and a number of individual antipsychotic medications. Using logistic regression, receiving haloperidol depot was the only antipsychotic-related factor predictive for metabolic syndrome. The prevalence of metabolic syndrome does not differ in schizophrenia whether patients are receiving polypharmacy and monotherapy nor do they differ for individual metabolic parameters. Most antipsychotic-related characteristics did not predict for metabolic syndrome.

  10. Learning from positively deviant wards to improve patient safety: an observational study protocol.

    Science.gov (United States)

    Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Lawton, Rebecca

    2015-12-11

    Positive deviance is an asset-based approach to improvement which has recently been adopted to improve quality and safety within healthcare. The approach assumes that solutions to problems already exist within communities. Certain groups or individuals identify these solutions and succeed despite having the same resources as others. Within healthcare, positive deviance has previously been applied at individual or organisational levels to improve specific clinical outcomes or processes of care. This study explores whether the positive deviance approach can be applied to multidisciplinary ward teams to address the broad issue of patient safety among elderly patients. Preliminary work analysed National Health Service (NHS) Safety Thermometer data from 34 elderly medical wards to identify 5 'positively deviant' and 5 matched 'comparison' wards. Researchers are blinded to ward status. This protocol describes a multimethod, observational study which will (1) assess the concurrent validity of identifying positively deviant elderly medical wards using NHS Safety Thermometer data and (2) generate hypotheses about how positively deviant wards succeed. Patient and staff perceptions of safety will be assessed on each ward using validated surveys. Correlation and ranking analyses will explore whether this survey data aligns with the routinely collected NHS Safety Thermometer data. Staff focus groups and researcher fieldwork diaries will be completed and qualitative thematic content analysis will be used to generate hypotheses about the strategies, behaviours, team cultures and dynamics that facilitate the delivery of safe patient care. The acceptability and sustainability of strategies identified will also be explored. The South East Scotland Research Ethics Committee 01 approved this study (reference: 14/SS/1085) and NHS Permissions were granted from all trusts. Findings will be published in peer-reviewed, scientific journals, and presented at academic conferences. This study

  11. Effects of chronic inflammatory bowel diseases on left ventricular structure and function: a study protocol

    Directory of Open Access Journals (Sweden)

    Botti Fiorenzo

    2002-09-01

    Full Text Available Abstract Background Experimental evidences suggest an increased collagen deposition in inflammatory bowel diseases (IBD. In particular, large amounts of collagen type I, III and V have been described and correlated to the development of intestinal fibrotic lesions. No information has been available until now about the possible increased collagen deposition far from the main target organ. In the hypothesis that chronic inflammation and increased collagen metabolism are reflected also in the systemic circulation, we aimed this study to evaluate the effects on left ventricular wall structure by assessing splancnic and systemic collagen metabolism (procollagen III assay, deposition (ultrasonic tissue characterization, and cardiac function (echocardiography in patients with different long standing history of IBD, before and after surgery. Methods Thirty patients affected by active IBD, 15 with Crohn and 15 with Ulcerative Colitis, submitted to surgery will be enrolled in the study in a double blind fashion. They will be studied before the surgical operation and 6, 12 months after surgery. A control group of 15 healthy age and gender-matched subjects will also be studied. At each interval blood samples will be collected in order to assess the collagen metabolism; a transthoracic echocardiogram will be recorded for the subsequent determination of cardiac function and collagen deposition. Discussion From this study protocol we expect additional information about the association between IBD and cardiovascular disorders; in particular to address the question if chronic inflammation, through the altered collagen metabolism, could affect left ventricular structure and function in a manner directly related to the estimated duration of the disease.

  12. A trial of a job-specific workers' health surveillance program for construction workers: study protocol.

    Science.gov (United States)

    Boschman, Julitta S; van der Molen, Henk F; van Duivenbooden, Cor; Sluiter, Judith K; Frings-Dresen, Monique H W

    2011-09-29

    Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS) to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS) group (n = 206) with that of a control (WHS) group (n = 206). The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the preventive actions undertaken by them within the scope of a job

  13. A trial of a job-specific workers' health surveillance program for construction workers: study protocol

    Directory of Open Access Journals (Sweden)

    Sluiter Judith K

    2011-09-01

    Full Text Available Abstract Background Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. Methods/Design The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS group (n = 206 with that of a control (WHS group (n = 206. The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. Discussion This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the

  14. Acute symptoms related to air pollution in urban areas: a study protocol

    Directory of Open Access Journals (Sweden)

    Forouzanfar Mohammad

    2006-08-01

    Full Text Available Abstract Background The harmful effects of urban air pollution on general population in terms of annoying symptoms are not adequately evaluated. This is in contrast to the hospital admissions and short term mortality. The present study protocol is designed to assess the association between the level of exposure to certain ambient air pollutants and a wide range of relevant symptoms. Awareness of the impact of pollution on the population at large will make our estimates of the pertinent covert burden imposed on the society more accurate. Methods/design A cross sectional study with spatial analysis for the addresses of the participants was conducted. Data were collected via telephone interviews administered to a representative sample of civilians over age four in the city. Households were selected using random digit dialling procedures and randomization within each household was also performed to select the person to be interviewed. Levels of exposure are quantified by extrapolating the addresses of the study population over the air pollution matrix of the city at the time of the interview and also for different lag times. This information system uses the data from multiple air pollution monitoring stations in conjunction with meteorological data. General linear models are applied for statistical analysis. Discussion The important limitations of cross-sectional studies on acute effects of air pollution are personal confounders and measurement error for exposure. A wide range of confounders in this study are controlled for in the statistical analysis. Exposure error may be minimised by employing a validated geographical information system that provides accurate estimates and getting detailed information on locations of individual participants during the day. The widespread operation of open air conditioning systems in the target urban area which brings about excellent mixing of the outdoor and indoor air increases the validity of outdoor pollutants

  15. Efficacy of family mediation and the role of family violence: study protocol.

    Science.gov (United States)

    Cleak, Helen; Schofield, Margot; Bickerdike, Andrew

    2014-01-21

    Family law reforms in Australia require separated parents in dispute to attempt mandatory family dispute resolution (FDR) in community-based family services before court attendance. However, there are concerns about such services when clients present with a history of high conflict and family violence. This study protocol describes a longitudinal study of couples presenting for family mediation services. The study aims to describe the profile of family mediation clients, including type of family violence, and determine the impact of violence profiles on FDR processes and outcomes, such as the type and durability of shared parenting arrangements and clients' satisfaction with mediated agreements. A mixed method, naturalistic longitudinal design is used. The sampling frame is clients presenting at nine family mediation centres across metropolitan, outer suburban, and regional/rural sites in Victoria, Australia. Data are collected at pre-test, completion of mediation, and six months later. Self-administered surveys are administered at the three time points, and a telephone interview at the final post-test. The key study variable is family violence. Key outcome measures are changes in the type and level of acrimony and violent behaviours, the relationship between violence and mediated agreements, the durability of agreements over six months, and client satisfaction with mediation. Family violence is a major risk to the physical and mental health of women and children. This study will inform debates about the role of family violence and how to manage it in the family mediation context. It will also inform decision-making about mediation practices by better understanding how mediation impacts on parenting agreements, and the implications for children, especially in the context of family violence.

  16. [Immunogenetic study in a case of DiGeorge syndrome].

    Science.gov (United States)

    Ramos Artana, M; Orea Solano, M; Flores Sandoval, G

    1993-01-01

    DiGeorge Syndrome is a congenital immunodeficiency characterized clinically by hypocalcemic tetany, congenital heart disease, unusual facies, and increased susceptibility to infection. Pathologically, the syndrome is marked by the abscence or hipoplasia of the thymus and parathyroid glands as well as cardiac or aortic arch abnormalities. Most patients show partial or complete T cell immunodeficiency and normal or near-normal B-cell immunity. A review is made on a clinical case of DiGeorge syndrome is presented. A 52 days old boy, was admitted through emergency. There was no familial evidence of alcoholism or immunodeficiency. He showed irritability due to hypocalcemia. The examination revealed facial and cardiovascular abnormalities and the immunological investigation revealed hypogammaglobulinemia, deficiency of the cell, CD4 and CD8 decreased and with inverted relation. Chest X ray showed cardiomegaly grade II, and no thymus was seen. The diagnosis of the complete DiGeorge syndrome was based on the abnormalities found.

  17. Case Study: The dietary management of irritable bowel syndrome ...

    African Journals Online (AJOL)

    , Dianne Ivison. Abstract. Keywords: irritable bowel syndrome, functional gastrointestinal disorders, FODMAPs, probiotics. Full Text: EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT.

  18. Iliopsoas Syndrome in Dancers.

    Science.gov (United States)

    Laible, Catherine; Swanson, David; Garofolo, Garret; Rose, Donald J

    2013-08-01

    Coxa saltans refers to a constellation of diagnoses that cause snapping of the hip and is a major cause of anterior hip pain in dancers. When the internal type is accompanied by weakness or pain, it is referred to as iliopsoas syndrome. Iliopsoas syndrome is the result of repetitive active hip flexion in abduction and can be confused with other hip pathology, most commonly of labral etiology. To report the incidence, clinical findings, treatment protocol, and results of treatment for iliopsoas syndrome in a population of dancers. Retrospective case series; Level of evidence, 4. A retrospective database review of 653 consecutive patients evaluated for musculoskeletal complaints over a 3-year period was completed. The diagnosis of iliopsoas syndrome was made based on anterior hip or groin pain, weakness with resisted hip flexion in abduction, or symptomatic clicking or snapping with a positive iliopsoas test. Patients identified with iliopsoas syndrome were further stratified according to age at time of onset, insidious versus acute onset, duration of symptoms, side of injury, presence of rest pain, pain with activities of daily living, and associated lower back pain. All patients diagnosed with iliopsoas syndrome underwent physical therapy, including hip flexor stretching and strengthening, pelvic mobilization, and modification of dance technique or exposure as required. A total of 49 dancers were diagnosed and treated for iliopsoas syndrome. Within this injured population of 653 patients, the incidence in female dancers was 9.2%, significantly higher than that in male dancers (3.2%). The mean age at the time of injury was 24.6 years. The incidence of iliopsoas syndrome in dancers younger than 18 years was 12.8%, compared with 7% in dancers older than 18 years. Student dancers had the highest incidence (14%), followed by amateur dancers (7.5%), while professional dancers had the lowest incidence (4.6%). All patients responded to conservative treatment, and no

  19. Regional gastrointestinal transit and pH studied in 215 healthy volunteers using the wireless motility capsule: influence of age, gender, study country and testing protocol.

    Science.gov (United States)

    Wang, Y T; Mohammed, S D; Farmer, A D; Wang, D; Zarate, N; Hobson, A R; Hellström, P M; Semler, J R; Kuo, B; Rao, S S; Hasler, W L; Camilleri, M; Scott, S M

    2015-09-01

    The wireless motility capsule (WMC) offers the ability to investigate luminal gastrointestinal (GI) physiology in a minimally invasive manner. To investigate the effect of testing protocol, gender, age and study country on regional GI transit times and associated pH values using the WMC. Regional GI transit times and pH values were determined in 215 healthy volunteers from USA and Sweden studied using the WMC over a 6.5-year period. The effects of test protocol, gender, age and study country were examined. For GI transit times, testing protocol was associated with differences in gastric emptying time (GET; shorter with protocol 2 (motility capsule ingested immediately after meal) vs. protocol 1 (motility capsule immediately before): median difference: 52 min, P = 0.0063) and colonic transit time (CTT; longer with protocol 2: median 140 min, P = 0.0189), but had no overall effect on whole gut transit time. Females had longer GET (by median 17 min, P = 0.0307), and also longer CTT by (104 min, P = 0.0285) and whole gut transit time by (263 min, P = 0.0077). Increasing age was associated with shorter small bowel transit time (P = 0.002), and study country also influenced small bowel and CTTs. Whole gut and CTTs showed clustering of data at values separated by 24 h, suggesting that describing these measures as continuous variables is invalid. Testing protocol, gender and study country also significantly influenced pH values. Regional GI transit times and pH values, delineated using the wireless motility capsule (WMC), vary based on testing protocol, gender, age and country. Standardisation of testing is crucial for cross-referencing in clinical practice and future research. © 2015 John Wiley & Sons Ltd.

  20. Characterisation of exposure to non-ionising electromagnetic fields in the Spanish INMA birth cohort: Study protocol

    NARCIS (Netherlands)

    M. Gallastegi (Mara); M. Guxens Junyent (Mònica); A. Jiménez-Zabala (Ana); I. Calvente (Irene); M. Fernández (Marta); L. Birks (Laura); B. Struchen (Benjamin); M. Vrijheid (Martine); M. Estarlich (Marisa); M.F. Fernandez (Mariana); M. Torrent (Maties); F. Ballester (Ferran); J.J. Aurrekoetxea (Juan José); J. Ibarluzea (Jesús); D. Guerra (David); J. González (Julián); M. Röösli (Martin); L. Santa-Marina (Loreto)

    2016-01-01

    textabstractBackground: Analysis of the association between exposure to electromagnetic fields of non-ionising radiation (EMF-NIR) and health in children and adolescents is hindered by the limited availability of data, mainly due to the difficulties on the exposure assessment. This study protocol

  1. Defining antimicrobial stewardship competencies for undergraduate health professional education in the United Kingdom: A study protocol.

    Science.gov (United States)

    Courtenay, Molly; Castro-Sánchez, Enrique; Deslandes, Rhian; Hodson, Karen; Lim, Rosemary; Morris, Gary; Reeves, Scott; Weiss, Marjorie

    2018-04-16

    Multi-drug resistant infections have been identified as one of the greatest threats to human health. Healthcare professionals are involved in an array of patient care activities for which an understanding of antimicrobial stewardship is important. Although antimicrobial prescribing and stewardship competencies have been developed for healthcare professionals who adopt the role of a prescriber, competencies do not exist for other medicine-related stewardship activities. Undergraduate education provides an ideal opportunity to prepare healthcare professionals for these roles and activities. This report presents a protocol for a study designed to provide national consensus on antimicrobial stewardship competencies appropriate for undergraduate healthcare professional education. A modified Delphi process will be used in which a panel of Experts, comprising members from across the United Kingdom, with expertise in prescribing and medicines management with regard to the education and practice of healthcare professionals, and antimicrobial prescribing and stewardship, will be invited to take part in two survey rounds. The competencies developed will be applicable to all undergraduate healthcare professional education programmes. They will help to standardise curricula content and enhance the impact of antimicrobial stewardship education.

  2. Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme European QUality Improvement Programme for Acute Coronary Syndrome: The EQUIP-ACS project protocol and design

    Directory of Open Access Journals (Sweden)

    Bardaji Alfredo

    2010-01-01

    Full Text Available Abstract Background Acute coronary syndromes, including myocardial infarction and unstable angina, are important causes of premature mortality, morbidity and hospital admissions. Acute coronary syndromes consume large amounts of health care resources, and have a major negative economic and social impact through days lost at work, support for disability, and coping with the psychological consequences of illness. Several registries have shown that evidence based treatments are under-utilised in this patient population, particularly in high-risk patients. There is evidence that systematic educational programmes can lead to improvement in the management of these patients. Since application of the results of important clinical trials and expert clinical guidelines into clinical practice leads to improved patient care and outcomes, we propose to test a quality improvement programme in a general group of hospitals in Europe. Methods/Design This will be a multi-centre cluster-randomised study in 5 European countries: France, Spain, Poland, Italy and the UK. Thirty eight hospitals will be randomised to receive a quality improvement programme or no quality improvement programme. Centres will enter data for all eligible non-ST segment elevation acute coronary syndrome patients admitted to their hospital for a period of approximately 10 months onto the study database and the sample size is estimated at 2,000-4,000 patients. The primary outcome is a composite of eight measures to assess aggregate potential for improvement in the management and treatment of this patient population (risk stratification, early coronary angiography, anticoagulation, beta-blockers, statins, ACE-inhibitors, clopidogrel as a loading dose and at discharge. After the quality improvement programme, each of the eight measures will be compared between the two groups, correcting for cluster effect. Discussion If we can demonstrate important improvements in the quality of patient care as

  3. Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cabassa, Leopoldo J; Stefancic, Ana; O'Hara, Kathleen; El-Bassel, Nabila; Lewis-Fernández, Roberto; Luchsinger, José A; Gates, Lauren; Younge, Richard; Wall, Melanie; Weinstein, Lara; Palinkas, Lawrence A

    2015-09-02

    The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese. The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial. This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI. www

  4. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

    Directory of Open Access Journals (Sweden)

    Smith Chad E.

    2014-09-01

    Full Text Available Purpose. Complex training (CT involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the inclusion of a power exercise instead of a strength exercise as the first exercise in CT would produce differences in lower body power. Methods. Thirty-six recreationally-trained men and women aged 20 to 29 years attending a college physical education course were randomly assigned to one of three groups: squat and countermovement squat jumps (SSJ, kettlebell swings and countermovement squat jumps (KSJ, and a control (CON. Training involving CT lasted 6 weeks. All participants were pre- and posttested for vertical jump performance in order to assess lower body power. Results. Vertical jump scores improved for all groups (p < 0.01. The results also indicated that there were no statistically significant differences between group scores across time (p = 0.215. The statistical power for this analysis was low (0.312, most likely due to the small sample size. However, the results did reveal a trend suggesting that the training improvements were greater for both the SSJ and KSJ groups compared with the CON (by 171% and 107%, respectively although significance was not reached. Conclusions. Due to the observed trend, a replication of this study with a greater number of participants over a longer period of time is warranted.

  5. The Malaysian Breast Cancer Survivorship Cohort (MyBCC): a study protocol.

    Science.gov (United States)

    Islam, Tania; Bhoo-Pathy, Nirmala; Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohd; Ng, Chong Guan; Dahlui, Maznah; Hussain, Samsinah; Cantwell, Marie; Murray, Liam; Taib, Nur Aishah

    2015-10-26

    Over recent decades, the burden of breast cancer has been increasing at an alarming rate in Asia. Prognostic research findings from Western countries may not readily be adapted to Asia, as the outcome of breast cancer depends on a multitude of factors ranging from genetic, clinical and histological predictors, to lifestyle and social predictors. The primary aim of this study is to determine the impact of lifestyle (eg, nutrition, physical activity), mental and sociocultural condition, on the overall survival and quality of life (QoL) among multiethnic Malaysian women following diagnosis of breast cancer. This study aims to advance the evidence on prognostic factors of breast cancer within the Asian setting. The findings may guide management of patients with breast cancer not only during active treatment but also during the survivorship period. This hospital-based prospective cohort study will comprise patients with breast cancer (18 years and above), managed in the University Malaya Medical Centre (UMMC). We aim to recruit 1000 cancer survivors over a 6-year period. Data collection will occur at baseline (within 3 months of diagnosis), 6 months, and 1, 3 and 5 years following diagnosis. The primary outcomes are disease-free survival and overall survival, and secondary outcome is QoL. Factors measured are demographic and socioeconomic factors, lifestyle factors (eg, dietary intake, physical activity), anthropometry measurements (eg, height, weight, waist, hip circumference, body fat analysis), psychosocial aspects, and complementary and alternative medicine (CAM) usage. This protocol was approved by the UMMC Ethical Committee in January 2012. All participants are required to provide written informed consent. The findings from our cohort study will be disseminated via scientific publication as well as presentation to stakeholders including the patients, clinicians, the public and policymakers, via appropriate avenues. Published by the BMJ Publishing Group

  6. Impact of the implementation of electronic guidelines for cardiovascular prevention in primary care: study protocol

    Directory of Open Access Journals (Sweden)

    Eva Comin

    2013-03-01

    Full Text Available Background The electronic medical records software of the Catalan Institute of Health has recently incorporated an electronic version of clinical practice guidelines (e-CPGs. This study aims to assess the impact of the implementation of e-CPGs on the diagnosis, treatment, control and management of hypercholesterolaemia, diabetes mellitus type 2 and hypertension.Methods Eligible study participants are those aged 35–74 years assigned to family practitioners (FPs of the Catalan Institute of Health. Routinely collected data from electronic primary care registries covering 80% of the Catalan population will be analysed using two approaches: (1 a cross-sectional study to describe the characteristics of the sample before e-CPG implementation; (2 a controlled before-and-after study with 1-year follow-up to ascertain the effect of e-CPG implementation. Patients of FPs who regularly use the e-CPGs will constitute the intervention group; the control group will comprise patients assigned to FPs not regularly using the e-CPG. The outcomes are: (1 suspected and confirmed diagnoses, (2 control of clinical variables, (3 requests for tests and (4 proportions of patients with adequate drug prescriptions.Results This protocol should represent a reproducible process to assess the impact of the implementation of e-CPGs. We anticipate reporting results in late 2013.Conclusion This project will assess the effectiveness of e-CPGs to improve clinical decisions and healthcare procedures in the three disorders analysed. The results will shed light on the use of evidence-based medicine to improve clinical practice of FPs.

  7. Describing the first 2000 registrations to the Research Registry®: A study protocol

    Directory of Open Access Journals (Sweden)

    Alexander J. Fowler

    Full Text Available Background: In 2013, the Declaration of Helsinki was updated and required the registration of all research studies involving human participants. Prior registries focussed on the registration of clinical trials and systematic reviews, and we estimate that only 10% of observational research is registered in a publically accessible registry. The Research Registry® was established to provide a venue of registration for any study, prospectively or retrospectively, involving human participants. This protocol describes the analysis for the first 2000 registrations received to the Research Registry®. Methods and analysis: Data for each registration to the Research Registry® (www.researchregistry.com, adapted from the World Health Organisation minimum data set, has been collected since the launch of the registry in 2015. A weekly curation process ensures that inappropriate registrations, such as duplicate studies or those not involving human participants, are removed from the registry. We will present the characteristics of the first 2000 registrations and how they have changed overtime. A quality score will be calculated for each registration by two independent teams, and inter-rater reliability will be calculated. Funding sources of work registered will also be presented. This process will also be performed for the systematic review portion of the registry (‘The Review Registry’, which will be considered separately. Ethics and dissemination: Ethical approval is not required for this study as it involves no human participants. The findings will be presented at international conferences and published in a peer reviewed journal.

  8. DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol

    Directory of Open Access Journals (Sweden)

    Kiss Alex

    2009-05-01

    Full Text Available Abstract Background The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management. Methods and design The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed. Discussion The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management. Trial Registration Protocol NCT00325624

  9. DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol.

    Science.gov (United States)

    Tobe, Sheldon W; Wentworth, Joan; Ironstand, Laurie; Hartman, Susan; Hoppe, Jackie; Whiting, Judi; Kennedy, Janice; McAllister, Colin; Kiss, Alex; Perkins, Nancy; Vincent, Lloyd; Pylypchuk, George; Lewanczuk, Richard Z

    2009-05-09

    The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management. The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed. The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel) study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management. Protocol NCT00325624.

  10. Promoting fit bodies, healthy eating and physical activity among Indigenous Australian men: a study protocol

    Directory of Open Access Journals (Sweden)

    Ricciardelli Lina A

    2012-01-01

    Full Text Available Abstract Background Overall the physical health of Indigenous men is among the worst in Australia. Research has indicated that modifiable lifestyle factors, such as poor nutrition and physical inactivity, appear to contribute strongly to these poor health conditions. To effectively develop and implement strategies to improve the health of Australia's Indigenous peoples, a greater understanding is needed of how Indigenous men perceive health, and how they view and care for their bodies. Further, a more systematic understanding of how sociocultural factors affect their health attitudes and behaviours is needed. This article presents the study protocol of a community-based investigation into the factors surrounding the health and body image of Indigenous Australian men. Methods and design The study will be conducted in a collaborative