WorldWideScience

Sample records for open-label two-month follow-up

  1. Postural and Balance Disorders in Patients with Parkinson's Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

    Science.gov (United States)

    Santamato, Andrea; Ranieri, Maurizio; Cinone, Nicoletta; Stuppiello, Lucia Anna; Valeno, Giovanni; De Sanctis, Jula Laura; Fortunato, Francesca; Solfrizzi, Vincenzo; Greco, Antonio; Seripa, Davide; Panza, Francesco

    2015-01-01

    Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson's disease (PD) to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy) for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients. PMID:26798551

  2. Postural and Balance Disorders in Patients with Parkinson’s Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

    Directory of Open Access Journals (Sweden)

    Andrea Santamato

    2015-01-01

    Full Text Available Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson’s disease (PD to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients.

  3. Six-month open-label follow-up of risperidone long-acting injection use in pediatric bipolar disorder.

    Science.gov (United States)

    Boarati, Miguel A; Wang, Yuan-Pang; Ferreira-Maia, Ana Paula; Cavalcanti, Ana Rosa S; Fu-I, Lee

    2013-01-01

    Recent studies suggest that risperidone long-acting injection (RLAI) may be considered for controlling mood episodes in bipolar disorder patients who have relapsed due to medication nonadherence or failure to respond to standard therapies. Currently, no study has reported the usefulness of RLAI in youths with bipolar disorder. The aim of this study was to evaluate short-term effects of RLAI in the naturalistic treatment of early-onset bipolar disorder and its role in symptomatic remission and adherence to treatment. Nineteen early-onset bipolar disorder outpatients receiving RLAI were observed in a 6-month naturalistic study at the outpatient clinic of the Child and Adolescent Affective Disorders Program at the Institute of Psychiatry of the University of São Paulo, São Paulo, Brazil. All patients met DSM-IV criteria for bipolar disorder. Clinical response to RLAI was evaluated using the Children's Global Assessment Scale (CGAS) and Clinical Global Impressions scale (CGI) across 3 time periods: index time (T0), 8 weeks after (T1), and 24 weeks after (T2). These subjects were recruited from May 2008 to December 2009. Patients receiving RLAI presented considerable improvement in global functioning (CGAS: T0 = 20.6; T1 = 42.9; and T2 = 49.2) and clinical severity (CGI: T0 = 5.9; T1 = 3.9; and T2 = 3.4). Global CGI mean scores of clinical improvement were 2.2 at T1 and 2.4 at T2. There were no significant changes in laboratory measurements and weight throughout follow-up. RLAI was shown to be an alternative treatment for youths with bipolar disorder failing to respond to prior medication trials or with adherence problems. Further blind, randomized controlled studies are necessary to confirm these initial findings. Sistema Nacional de Informaçōes Sobre Ética em Pesquisa Envolvendo Seres Humanos-Commisão Nacional de Ética em Pesquisa identifier: CAAE 0709.0.015.000-06.

  4. Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: Open-label, noncomparative, multicenter, long-term follow-up study.

    LENUS (Irish Health Repository)

    Delanty, Norman

    2012-02-01

    Purpose: To evaluate the long-term efficacy and tolerability of adjunctive levetiracetam (LEV) in patients with uncontrolled idiopathic generalized epilepsy (IGE). Methods: This phase III, open-label, long-term, follow-up study (N167; NCT00150748) enrolled patients (4 to <65 years) with primary generalized seizures (tonic-clonic, myoclonic, absence). Patients received adjunctive LEV at individualized doses (1,000-4,000 mg\\/day; 20-80 mg\\/kg\\/day for children\\/adolescents weighing <50 kg). Efficacy results are reported for all seizure types [intention-to-treat (ITT) population, N = 217] and subpopulations with tonic-clonic (n = 152), myoclonic (n = 121), and\\/or absence (n = 70) seizures at baseline. Key Findings: One hundred twenty-five (57.6%) of 217 patients were still receiving treatment at the end of the study. Mean (standard deviation, SD) LEV dose was 2,917.5 (562.9) mg\\/day. Median (Q1-Q3) exposure to LEV was 2.1 (1.5-2.8) years, and the maximum duration was 4.6 years. Most patients were taking one (124\\/217, 57.1%) or >\\/=2 (92\\/217, 42.4%) concomitant antiepileptic drugs (AEDs). Seizure freedom of >\\/=6 months (all seizure types; primary efficacy end point) was achieved by 122 (56.2%) of 217 patients, and 49 (22.6%) of 217 patients had complete seizure freedom. Seizure freedom of >\\/=6 months from tonic-clonic, myoclonic, and absence seizures was achieved by 95 (62.5%) of 152, 75 (62.0%) of 121, and 44 (62.9%) of 70 patients, respectively. Mean (SD) maximum seizure freedom duration was 371.7 (352.4) days. At least one treatment-emergent adverse event (TEAE) was reported by 165 (76%) of 217 patients; most TEAEs were mild\\/moderate in severity, with no indication of an increased incidence over time. Seventeen (7.8%) of 217 patients discontinued medication because of TEAEs. The most common psychiatric TEAEs were depression (16\\/217, 7.4%), insomnia (9\\/217, 4.1%), nervousness (8\\/217, 3.7%), and anxiety (7\\/217, 3.2%). Significance: Adjunctive

  5. Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence

    DEFF Research Database (Denmark)

    Toozs-Hobson, Philip; Al-Singary, Waleed; Fynes, Michelle

    2012-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence....

  6. Effects of a structured 20-session slow-cortical-potential-based neurofeedback program on attentional performance in children and adolescents with attention-deficit hyperactivity disorder: retrospective analysis of an open-label pilot-approach and 6-month follow-up.

    Science.gov (United States)

    Albrecht, Johanna S; Bubenzer-Busch, Sarah; Gallien, Anne; Knospe, Eva Lotte; Gaber, Tilman J; Zepf, Florian D

    2017-01-01

    The aim of this approach was to conduct a structured electroencephalography-based neurofeedback training program for children and adolescents with attention-deficit hyperactivity disorder (ADHD) using slow cortical potentials with an intensive first (almost daily sessions) and second phase of training (two sessions per week) and to assess aspects of attentional performance. A total of 24 young patients with ADHD participated in the 20-session training program. During phase I of training (2 weeks, 10 sessions), participants were trained on weekdays. During phase II, neurofeedback training occurred twice per week (5 weeks). The patients' inattention problems were measured at three assessment time points before (pre, T0) and after (post, T1) the training and at a 6-month follow-up (T2); the assessments included neuropsychological tests (Alertness and Divided Attention subtests of the Test for Attentional Performance; Sustained Attention Dots and Shifting Attentional Set subtests of the Amsterdam Neuropsychological Test) and questionnaire data (inattention subscales of the so-called Fremdbeurteilungsbogen für Hyperkinetische Störungen and Child Behavior Checklist/4-18 [CBCL/4-18]). All data were analyzed retrospectively. The mean auditive reaction time in a Divided Attention task decreased significantly from T0 to T1 (medium effect), which was persistent over time and also found for a T0-T2 comparison (larger effects). In the Sustained Attention Dots task, the mean reaction time was reduced from T0-T1 and T1-T2 (small effects), whereas in the Shifting Attentional Set task, patients were able to increase the number of trials from T1-T2 and significantly diminished the number of errors (T1-T2 & T0-T2, large effects). First positive but very small effects and preliminary results regarding different parameters of attentional performance were detected in young individuals with ADHD. The limitations of the obtained preliminary data are the rather small sample size, the

  7. Effects of a structured 20-session slow-cortical-potential-based neurofeedback program on attentional performance in children and adolescents with attention-deficit hyperactivity disorder: retrospective analysis of an open-label pilot-approach and 6-month follow-up

    Directory of Open Access Journals (Sweden)

    Albrecht JS

    2017-03-01

    Full Text Available Johanna S Albrecht,1–3 Sarah Bubenzer-Busch,1,2 Anne Gallien,1,4 Eva Lotte Knospe,1,2 Tilman J Gaber,1,2,5 Florian D Zepf1,2,6,7 1Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, RWTH Aachen University, Aachen, 2JARA Translational Brain Medicine, Aachen & Jülich, 3Center for Pediatrics and Adolescent Medicine Elisabeth Hospital Rheydt, Mönchengladbach, 4Clinic for Neurology, Medical Center City Region Aachen, Würselen, 5NeuroCare Group, Munich, Germany; 6Centre and Discipline of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, School of Paediatrics and Child Health & School of Psychiatry and Clinical Neurosciences, Faculty of Medicine, Dentistry and Health Sciences, The University of Western Australia, 7Department of Health in Western Australia, Specialised Child and Adolescent Mental Health Services, Perth, WA, Australia Objective: The aim of this approach was to conduct a structured electroencephalography-based neurofeedback training program for children and adolescents with attention-deficit hyperactivity disorder (ADHD using slow cortical potentials with an intensive first (almost daily sessions and second phase of training (two sessions per week and to assess aspects of attentional performance. Patients and methods: A total of 24 young patients with ADHD participated in the 20-session training program. During phase I of training (2 weeks, 10 sessions, participants were trained on weekdays. During phase II, neurofeedback training occurred twice per week (5 weeks. The patients’ inattention problems were measured at three assessment time points before (pre, T0 and after (post, T1 the training and at a 6-month follow-up (T2; the assessments included neuropsychological tests (Alertness and Divided Attention subtests of the Test for Attentional Performance; Sustained Attention Dots and Shifting Attentional Set subtests of the Amsterdam Neuropsychological Test and questionnaire data

  8. Treatment and Follow Up

    Science.gov (United States)

    ... Close Celiac Disease Understanding Celiac Disease What is Celiac Disease? Symptoms Screening and Diagnosis Treatment and Follow-Up Dermatitis ... you find the right healthcare practitioner to discuss symptoms, diagnose, and ... Our nationwide Healthcare Practitioner Directory lists primary care ...

  9. Follow-Up Testing

    Science.gov (United States)

    ... second should occur after 1 year on the gluten-free diet. After that, a celiac should receive follow-up ... test result is straightforward—a celiac on the gluten-free diet should have a negative test. The numerical value ...

  10. CONTRACT FOLLOW UP TRAINING

    CERN Multimedia

    Technical Training; Tel. 74460

    2001-01-01

    SPL is organizing Training Sessions on the Contract Follow Up application. CFU is a Web based tool, developped and supported by the Administrative Information Services. It allows the creation of Divisional Requests and the follow up of their processing, from the Market Survey to the Invitation to Tender or Price Enquiry, approval by the Finance Committee, up to the actual signature of a Contract, acccording to the CERN Purchasing procedures. It includes a document management component. It also provides link with other AIS applications such as BHT and EDH. The course is primarily intended for DPOs, Contract Technical responsibles in the division and their assistants, but is beneficial to anybody involved in the follow up of such Purchasing Procedures. This course is free of charge, but application is necessary. The details of the course may be found at http://training.web.cern.ch/Training/ENSTEC/P2001/Bureautique/cfu4_f.htm General information of CFU may be found at http://ais.cern.ch/apps/cfu/ The dates of t...

  11. Atomoxetine Open-Label Trial in ADHD

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2002-07-01

    Full Text Available Atomoxetine (originally named tomoxetine, a new therapy for attention deficit hyperactivity disorder (ADHD marketed by Eli Lilly, was compared to methylphenidate in a prospective, randomized, open-label study for 10 weeks duration, at the University of Nebraska Medical Center, Massachusetts General Hospital, Mount Sinai Medical Center, Carolinas Medical Center, and Lilly Research Laboratories.

  12. 15-Year Follow-Up

    OpenAIRE

    Karjula, Salla; Morin-Papunen, Laure; Auvinen, Juha; Ruokonen, Aimo; Puukka, Katri; Franks, Stephen; Jarvelin, Marjo-Riitta; Tapanainen, Juha S.; Jokelainen, Jari; Miettunen, Jouko; Piltonen, Terhi T.

    2017-01-01

    Context: Polycystic ovary syndrome (PCOS) is associated with increased psychological distress, obesity and hyperandrogenism being suggested as key promoters. Objectives: To investigate the prevalence of anxiety/depression and their coexistence in women with PCOS/PCOS-related symptoms at ages 31 and 46. The roles of obesity, hyperandrogenism, and awareness of PCOS on psychological distress were also assessed. Design: Population-based follow-up. Setting: Northern Finland Birth Cohort 1966 with ...

  13. Open-label placebo treatment in chronic low back pain: a randomized controlled trial.

    Science.gov (United States)

    Carvalho, Cláudia; Caetano, Joaquim Machado; Cunha, Lidia; Rebouta, Paula; Kaptchuk, Ted J; Kirsch, Irving

    2016-12-01

    This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland-Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (-0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain.

  14. Towards sustainability assessment follow-up

    Energy Technology Data Exchange (ETDEWEB)

    Morrison-Saunders, Angus, E-mail: a.morrison-saunders@murdoch.edu.au [Murdoch University (Australia); North-West University (South Africa); Pope, Jenny, E-mail: jenny@integral-sustainability.net [North-West University (South Africa); Integral Sustainability (Australia); Curtin University (Australia); Bond, Alan, E-mail: alan.bond@uea.ac.uk [North-West University (South Africa); University of East Anglia (United Kingdom); Retief, Francois, E-mail: francois.retief@nwu.ac.za [North-West University (South Africa)

    2014-02-15

    This paper conceptualises what sustainability assessment follow-up might entail for three models of sustainability assessment: EIA-driven integrated assessment, objectives-led integrated assessment and the contribution to sustainability model. The first two are characterised by proponent monitoring and evaluation of individual impacts and indicators while the latter takes a holistic view based around focused sustainability criteria relevant to the context. The implications of three sustainability challenges on follow-up are also examined: contested time horizons and value changes, trade-offs, and interdisciplinarity. We conclude that in order to meet these challenges some form of adaptive follow-up is necessary and that the contribution to sustainability approach is the best approach. -- Highlights: • We explore sustainability follow-up for three different sustainability models. • Long-time frames require adaptive follow-up and are a key follow-up challenge. • Other key challenges include interdisciplinarity, and trade-offs. • Sustainability follow-up should be a direction of travel and not an outcome. • Only the follow-up for contribution to sustainability model addresses sustainability challenges sufficiently.

  15. Follow-up utterances in QA dialogue

    NARCIS (Netherlands)

    van Schooten, B.W.; op den Akker, Hendrikus J.A.

    2006-01-01

    The processing of user follow-up utterances by a QA system is a topic which is still in its infant stages, but enjoys growing interest in the QA community. In this paper, we discuss the broader issues related to handling follow-up utterances in a real-life "information kiosk" setting. With help of a

  16. Towards sustainability assessment follow-up

    International Nuclear Information System (INIS)

    Morrison-Saunders, Angus; Pope, Jenny; Bond, Alan; Retief, Francois

    2014-01-01

    This paper conceptualises what sustainability assessment follow-up might entail for three models of sustainability assessment: EIA-driven integrated assessment, objectives-led integrated assessment and the contribution to sustainability model. The first two are characterised by proponent monitoring and evaluation of individual impacts and indicators while the latter takes a holistic view based around focused sustainability criteria relevant to the context. The implications of three sustainability challenges on follow-up are also examined: contested time horizons and value changes, trade-offs, and interdisciplinarity. We conclude that in order to meet these challenges some form of adaptive follow-up is necessary and that the contribution to sustainability approach is the best approach. -- Highlights: • We explore sustainability follow-up for three different sustainability models. • Long-time frames require adaptive follow-up and are a key follow-up challenge. • Other key challenges include interdisciplinarity, and trade-offs. • Sustainability follow-up should be a direction of travel and not an outcome. • Only the follow-up for contribution to sustainability model addresses sustainability challenges sufficiently

  17. Follow-up in Childhood Functional Constipation

    DEFF Research Database (Denmark)

    Modin, Line; Walsted, Anne-Mette; Rittig, Charlotte Siggaard

    2016-01-01

    OBJECTIVES: Guidelines recommend close follow-up during treatment of childhood functional constipation. Only sparse evidence exists on how follow-up is best implemented. Our aim was to evaluate if follow-up by phone or self-management through web-based information improved treatment outcomes....... METHODS: In this randomized, controlled trial, conducted in secondary care, 235 children, aged 2-16 years, who fulfilled the Rome III criteria of childhood constipation, were assigned to one of three follow-up regimens: (I) control group (no scheduled contact), (II) phone group (2 scheduled phone contacts......: Improved self-management behavior caused by access to self-motivated web-based information induced faster short-term recovery during treatment of functional constipation. Patient empowerment rather than health care promoted follow-up might be a step towards more effective treatment for childhood...

  18. Ethosuximide for Essential Tremor: An Open-Label Trial

    OpenAIRE

    Gironell, Alexandre; Marin-Lahoz, Juan

    2016-01-01

    Background: T-type calcium channel activation has been postulated to underlie rhythmicity in the olivo-cerebellar system that is implicated in ET. Ethosuximide reduces T-type calcium currents and can suppress tremor in two animal models of ET. We explored the effects of ethosuximide in subjects with ET in an open-label trial using both clinical scales and accelerometric recordings measures. We initially planned to conduct the trial with 15 patients, but due to lack of efficacy and a high inci...

  19. Minocycline treatment in acute stroke: an open-label, evaluator-blinded study.

    Science.gov (United States)

    Lampl, Y; Boaz, M; Gilad, R; Lorberboym, M; Dabby, R; Rapoport, A; Anca-Hershkowitz, M; Sadeh, M

    2007-10-02

    Ischemic animal model studies have shown a neuroprotective effect of minocycline. To analyze the effect of minocycline treatment in human acute ischemic stroke. We performed an open-label, evaluator-blinded study. Minocycline at a dosage of 200 mg was administered orally for 5 days. The therapeutic window of time was 6 to 24 hours after onset of stroke. Data from NIH Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Barthel Index (BI) were evaluated. The primary objective was to compare changes from baseline to day 90 in NIHSS in the minocycline group vs placebo. One hundred fifty-two patients were included in the study. Seventy-four patients received minocycline treatment, and 77 received placebo. NIHSS and mRS were significantly lower and BI scores were significantly higher in minocycline-treated patients. This pattern was already apparent on day 7 and day 30 of follow-up. Deaths, myocardial infarctions, recurrent strokes, and hemorrhagic transformations during follow-up did not differ by treatment group. Patients with acute stroke had significantly better outcome with minocycline treatment compared with placebo. The findings suggest a potential benefit of minocycline in acute ischemic stroke.

  20. Probiotics in diverticular disease of the colon: an open label study.

    Science.gov (United States)

    Lamiki, Pepu; Tsuchiya, Junji; Pathak, Surajit; Okura, Ruichi; Solimene, Umberto; Jain, Shalini; Kawakita, Shichiro; Marotta, Francesco

    2010-03-01

    To investigate the effectiveness and safety of a symbiotic mixture in preventing recurrence of constipation-related abdominal pain in patients with uncomplicated diverticular disease of the colon. Forty-six consecutive patients (10 men, 36 women, mean age 62.5 years, range 49 to 77 years), previously affected by symptomatic uncomplicated diverticular disease of the colon, were enrolled in a 6-month follow-up study in a prospective, randomized, open-label study. The following symptoms were assessed at entry and through follow-up by using a quantitative scale: constipation, diarrhoea and abdominal pain. After recruitment, the patients were assigned to the following treatment: SCM-III symbiotic mixture, 10 ml three times a day. The colonization of ingested Lactobacillus acidophilus 145 and Bifidobacterium spp. 420 was assessed by species-specific PCR. Forty-five patients completed the study (97%). Thirty-one patients (68%) were still symptom free after the 6th month of treatment. Treatment with SCM-III was regarded as "effective" or "very effective" in more than 78% of the patients altogether (pdiverticular disease of the colon, especially in those patients with constipation-predominant features.

  1. Audit Follow-up Tracking System (AFTS)

    Data.gov (United States)

    Office of Personnel Management — The Audit Follow-up Tracking System (AFTS) is used to track, monitor, and report on audits and open recommendations of the U.S. Office of Personnel Management (OPM)...

  2. Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance : Minimum 24-month follow-up

    NARCIS (Netherlands)

    Gambacorti-Passerini, Carlo; Brümmendorf, Tim H; Kim, Dong-Wook; Turkina, Anna G; Masszi, Tamas; Assouline, Sarit; Durrant, Simon; Kantarjian, Hagop M; Khoury, H Jean; Zaritskey, Andrey; Shen, Zhi-Xiang; Jin, Jie; Vellenga, Edo; Pasquini, Ricardo; Mathews, Vikram; Cervantes, Francisco; Besson, Nadine; Turnbull, Kathleen; Leip, Eric; Kelly, Virginia; Cortes, Jorge E

    Bosutinib is an orally active, dual Src/Abl tyrosine kinase inhibitor for treatment of chronic myeloid leukemia (CML) following resistance/intolerance to prior therapy. Here, we report the data from the 2-year follow-up of a phase 1/2 open-label study evaluating the efficacy and safety of bosutinib

  3. 12-month follow-up study of drug treatment in pathological gamblers: a primary outcome study.

    Science.gov (United States)

    Dannon, Pinhas N; Lowengrub, Katherine; Musin, Ernest; Gonopolsky, Yehudit; Kotler, Moshe

    2007-12-01

    Pathological gambling (PG) is a relatively common and highly disabling impulse control disorder. A range of psychotherapeutic agents including selective serotonin reuptake inhibitors, antiepileptic drugs, and opioid antagonists are shown to be effective in the short-term treatment of PG. The use of a wide range of pharmacological treatments for PG is consistent with the observation that PG shares features of obsessive-compulsive spectrum disorders, impulse control disorders, and addictive disorders. The aim of the study is to assess the rate of relapse in treatment-responder pathological gamblers after discontinuation of the active treatment. Our study sample was composed of 43 male pathological gamblers who had been full responders to 1 of 4 drug treatment regimens (fluvoxamine, topiramate, bupropion SR, or naltrexone) from several previous acute open-label (12-week) comparison studies. Full response was defined as the absence of gambling for a 1-month duration together with improvement on the Clinical Global Improvement scale. The 43 full responders were then followed prospectively for an additional 9 months, which included a 3-month open-label continuation phase and a 6-month medication-free follow-up phase. Follow-up visits were performed on a monthly basis throughout the duration of study. At every follow-up visit, a comprehensive psychiatric diagnostic evaluation was performed on all patients, and patients were assessed for symptoms of gambling using a self-report instrument and collateral family reports. The Clinical Global Impression Improvement scale was also administered at every follow-up visit. Raters were blind to the previous drug treatment. Most patients did not relapse during the 6-month medication-free follow-up phase. Three of 6 patients with fluvoxamine, 3 of 9 with topiramate, 7 of 18 with bupropion SR, and 4 of 10 with naltrexone relapsed. Relapse was strictly defined as gambling behavior at any time during the 6-month medication-free follow-up

  4. Rectal neoplasms. Postoperative follow-up

    International Nuclear Information System (INIS)

    Galano Urgelles, Rolando; Rodriguez Fernandez, Zenen; Casaus Prieto, Arbelio

    1997-01-01

    A study of 31 patients operated on for rectal neoplasms between September, 1989 and September, 1995 in SantiAug de Cuba was performed. Patients Webre followed-up during this period for the purpose of the study. There was a frank predominance of males and ages between 45 and 64, of the stage II and the groups BI and BII according to Dukes' classification. Most patients received 5-fluoracil, without tumor relapses. The current survival rate of the series was 76 % at the end of the investigation. It is recommended that all patients operated on for this segment be followed-up after the operation; to continue with cytostatic treatment using 5-fluoracil, and to emphasize the importance of the use of tumor markers during the follow-up, in addition to transrectal ultrasound, as well as to make an early diagnosis through mass screening methods

  5. Follow-up after rectal cancer

    DEFF Research Database (Denmark)

    Hovdenak Jakobsen, Ida; Juul, Therese; Bernstein, Inge

    2017-01-01

    BACKGROUND: The main treatment for non-metastatic rectal cancer (RC) is surgical resection. Late adverse effects that are highly prevalent and negatively impact patients' symptom burden and quality of life are: bowel-, urological and sexual dysfunctions; psychological distress; fear of recurrence....... As a consequence, the randomized controlled trial Follow-up after Rectal Cancer (FURCA) has been launched, testing the effect of a new patient-led, follow-up program. The aim of this paper is to describe the methodology used in the FURCA study and to report results from the development of the patient-led, follow......, or a control group following the current follow-up program with routine medicals. The primary outcomes are symptom burden and quality of life, measured by the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire. Other outcome and demographic data are collected as patient...

  6. The Kepler follow-up observation program

    DEFF Research Database (Denmark)

    Gautier...[], T.N.; Batalha, N.M.; Borucki, W. J.

    2010-01-01

    The Kepler Mission was launched on March 6, 2009 to perform a photometric survey of more than 100,000 dwarf stars to search for terrestrial-size planets with the transit technique. Follow-up observations of planetary candidates identified by detection of transit-like events are needed both...

  7. Comparison of oral psoralen-UV-A with a portable tanning unit at home vs hospital-administered bath psoralen-UV-A in patients with chronic hand eczema - An open-label randomized controlled trial of efficacy

    NARCIS (Netherlands)

    van Coevorden, AM; Kamphof, WG; van Sonderen, E; Bruynzeel, DP; Coenraads, PJ

    2004-01-01

    Objective: To study whether oral psoralen-UV-A (PUVA) with a portable tanning unit at home is as effective as hospital-administered bath PUVA in patients with chronic hand eczema. Design: Open-label randomized controlled trial, with a 10-week treatment period and an 8-week follow-up period. Setting:

  8. DRY CUPPING IN CHILDREN WITH FUNCTIONAL CONSTIPATION: A RANDOMIZED OPEN LABEL CLINICAL TRIAL.

    Science.gov (United States)

    Shahamat, Mahmoud; Daneshfard, Babak; Najib, Khadijeh-Sadat; Dehghani, Seyed Mohsen; Tafazoli, Vahid; Kasalaei, Afshineh

    2016-01-01

    As a common disease in pediatrics, constipation poses a high burden to the community. In this study, we aimed to investigate the efficacy of dry cupping therapy (an Eastern traditional manipulative therapy) in children with functional constipation. One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation. There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period. This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation.

  9. Autologous Bone Marrow Mononuclear Cell Therapy for Autism: An Open Label Proof of Concept Study

    Directory of Open Access Journals (Sweden)

    Alok Sharma

    2013-01-01

    Full Text Available Cellular therapy is an emerging therapeutic modality with a great potential for the treatment of autism. Recent findings show that the major underlying pathogenetic mechanisms of autism are hypoperfusion and immune alterations in the brain. So conceptually, cellular therapy which facilitates counteractive processes of improving perfusion by angiogenesis and balancing inflammation by immune regulation would exhibit beneficial clinical effects in patients with autism. This is an open label proof of concept study of autologous bone marrow mononuclear cells (BMMNCs intrathecal transplantation in 32 patients with autism followed by multidisciplinary therapies. All patients were followed up for 26 months (mean 12.7. Outcome measures used were ISAA, CGI, and FIM/Wee-FIM scales. Positron Emission Tomography-Computed Tomography (PET-CT scan recorded objective changes. Out of 32 patients, a total of 29 (91% patients improved on total ISAA scores and 20 patients (62% showed decreased severity on CGI-I. The difference between pre- and postscores was statistically significant (P<0.001 on Wilcoxon matched-pairs signed rank test. On CGI-II 96% of patients showed global improvement. The efficacy was measured on CGI-III efficacy index. Few adverse events including seizures in three patients were controlled with medications. The encouraging results of this leading clinical study provide future directions for application of cellular therapy in autism.

  10. Homoeopathic management of Schizophrenia: A prospective, non-comparative, open-label observational study

    Directory of Open Access Journals (Sweden)

    Praveen Oberai

    2016-01-01

    Full Text Available Objectives: To evaluate the usefulness of homoeopathic intervention in Schizophrenia, in untreated cases and antipsychotic treatment resistant cases, to verify indications of medicines, and to assess relapse, if any. Materials and Methods: A prospective, non-comparative, open-label observational study was carried out from October 2005-September 2010 by CCRH at Central Research Institute (H, Kottayam, Kerala, India. Patients between 20 and 60 years of age, presenting with symptoms of Schizophrenia were screened for inclusion and exclusion criteria. The patients who were on antipsychotic drugs were allowed to continue the same along with homoeopathic medicine, the dose of antipsychotics was monitored by the Psychiatrist. The symptoms of each patient were repertorized, and medicine was initially prescribed in 30C potency after consulting Materia Medica. Patients were followed up for 12 months. Outcome of treatment was assessed with Brief Psychiatric Rating Scales (BPRS. Analysis was done using Statistical Package for the Social Sciences  SPSS Version 20.0. Results: Out of 188 enrolled patients, 17 cases did not complete the baseline information. Total 171 patients were analysed as per modified Intention to Treat Principle. Significant difference (P = 0.0001, P < 0.05 in the mean scores of BPRS, using paired t test was observed at end of the study. Sulphur, Lycopodium, Natrum muriaticum, Pulsatilla and Phosphorus were found to be the most useful medicines in treating schizophrenic patients. Conclusion: The study reflects the positive role of homoeopathic medicines in the management of patients suffering from schizophrenia as measured by BPRS.

  11. Follow-up of colorectal cancer patients: quality of life and attitudes towards follow-up

    NARCIS (Netherlands)

    Stiggelbout, A. M.; de Haes, J. C.; Vree, R.; van de Velde, C. J.; Bruijninckx, C. M.; van Groningen, K.; Kievit, J.

    1997-01-01

    The aims of our study were to assess the effect of follow-up on the quality of life of colorectal cancer patients and to assess the attitudes of patients towards follow-up as a function of patient characteristics. Patients who had been treated with curative intent were selected from four types of

  12. Open-label study of donepezil in traumatic brain injury.

    Science.gov (United States)

    Masanic, C A; Bayley, M T; VanReekum, R; Simard, M

    2001-07-01

    To determine preliminarily whether donepezil will improve memory, behavior, and global function after chronic traumatic brain injury (TBI). Sixteen-week open-label study. Outpatient TBI rehabilitation program. Four patients with chronic, severe TBI. Donepezil 5mg daily for 8 weeks followed by 10mg daily for 4 weeks. Memory measures included the Rey Auditory Verbal Learning Test (RAVLT), the Complex Figure Test (CFT), items from the Rivermead Behavioural Memory Test (RBMT), and a semantic fluency task. The Neuropsychiatric Inventory (NPI) evaluated behavior and affect. Function was assessed by using the FIM instrument and a clinical global impression of change. On the RAVLT, the mean scores for learning and short- and long-term recall improved by 0.4, 1.04, and.83 standard deviations (SDs) above baseline, respectively. On the CFT, the mean scores for short-term recall and long-term recall improved by 1.56 and 1.38 SDs above baseline, respectively. A positive trend was observed on the RBMT and on the NPI subscales. Donepezil may improve some aspects of memory and behavior in persons with chronic TBI. Randomized clinical trials are required to support these preliminary findings. Copyright 2001 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation

  13. Ethosuximide for Essential Tremor: An Open-Label Trial

    Science.gov (United States)

    Gironell, Alexandre; Marin-Lahoz, Juan

    2016-01-01

    Background T-type calcium channel activation has been postulated to underlie rhythmicity in the olivo-cerebellar system that is implicated in ET. Ethosuximide reduces T-type calcium currents and can suppress tremor in two animal models of ET. We explored the effects of ethosuximide in subjects with ET in an open-label trial using both clinical scales and accelerometric recordings measures. We initially planned to conduct the trial with 15 patients, but due to lack of efficacy and a high incidence of adverse effects, the trial was stopped after seven patients had participated. Methods Seven patients diagnosed with ET were included in the study. The ethosuximide dose was 500 mg daily (BID). The main outcome measures were: 1) tremor clinical rating scale (TCRS) score, 2) accelerometric recordings, and 3) self-reported disability scale score. Results Five patients completed the study, and two dropped out due to adverse effects. There were no significant changes in clinical scores in motor task performance (TCRS 1+2), daily living activities (TCRS 3), or in the patients’ subjective assessment (TCRS 4) and global appraisal. There were no differences observed for accelerometry data or disability scale scores. Anxiety, nervousness, headache, and dizziness were reported by two patients while on ethosuximide, causing them to stop the trial. No patient preferred to continue ethosuximide treatment. Discussion The results of our exploratory study suggest that ethosuximide is not an effective treatment for ET. PMID:27625899

  14. Ethosuximide for Essential Tremor: An Open-Label Trial

    Directory of Open Access Journals (Sweden)

    Alexandre Gironell

    2016-07-01

    Full Text Available Background: T-type calcium channel activation has been postulated to underlie rhythmicity in the olivo-cerebellar system that is implicated in ET. Ethosuximide reduces T-type calcium currents and can suppress tremor in two animal models of ET. We explored the effects of ethosuximide in subjects with ET in an open-label trial using both clinical scales and accelerometric recordings measures. We initially planned to conduct the trial with 15 patients, but due to lack of efficacy and a high incidence of adverse effects, the trial was stopped after seven patients had participated. Methods: Seven patients diagnosed with ET were included in the study. The ethosuximide dose was 500 mg daily (BID. The main outcome measures were: 1 tremor clinical rating scale (TCRS score, 2 accelerometric recordings, and 3 self-reported disability scale score. Results: Five patients completed the study, and two dropped out due to adverse effects. There were no significant changes in clinical scores in motor task performance (TCRS 1+2, daily living activities (TCRS 3, or in the patients’ subjective assessment (TCRS 4 and global appraisal. There were no differences observed for accelerometry data or disability scale scores. Anxiety, nervousness, headache, and dizziness were reported by two patients while on ethosuximide, causing them to stop the trial. No patient preferred to continue ethosuximide treatment. Discussion: The results of our exploratory study suggest that ethosuximide is not an effective treatment for ET.

  15. Methylphenidate, cognition, and epilepsy: A 1-month open-label trial.

    Science.gov (United States)

    Adams, Jesse; Alipio-Jocson, Valerie; Inoyama, Katherine; Bartlett, Victoria; Sandhu, Saira; Oso, Jemima; Barry, John J; Loring, David W; Meador, Kimford J

    2017-12-01

    Cognitive difficulties are common in epilepsy. Beyond reducing seizures and adjusting antiepileptic medications, no well-validated treatment exists in adults. Methylphenidate is used effectively in children with epilepsy and attention-deficit/hyperactivity disorder, but its effects in adults have not been systematically evaluated. We hypothesized that methylphenidate can safely improve cognition in adults with epilepsy. We detail here the open-label follow-up to a double-blind, placebo-controlled, single-dose study. Thirty epilepsy patients entered a 1-month open-label methylphenidate trial after a double-blind phase. Doses were titrated according to clinical practice and patient tolerance, ranging 20-40 mg/day. Primary measures included: Conners' Continuous Performance Test (CPT), Symbol-Digit Modalities Test (SDMT), and Medical College of Georgia Memory Test (MCG). Secondary measures were: Beck Depression Inventory, 2nd Edition (BDI-II), Beck Anxiety Inventory, Apathy Evaluation Scale (AES), Stimulant Side-Effect Checklist, Adverse Events Profile, Quality of Life in Epilepsy-89 (QOLIE-89), and seizure frequency. Fourteen healthy, nonmedicated controls were tested concurrently. Twenty-eight participants with epilepsy (13 men/15 women) completed the trial. Withdrawals occurred due to anxiety (n = 1) and fatigue (n = 1). Mean age was 36.4 years (range = 20-60). Epilepsy types were: focal (n = 21), generalized (n = 6), or unclassified (n = 1). Mean epilepsy duration was 12.3 years. Mean baseline seizure frequency was 2.8/month. There were significant improvements on methylphenidate for SDMT, MCG, CPT (the ability to discriminate between targets and nontargets [d'] hits, hit reaction time standard deviation, omissions, and commissions), and QOLIE subscales (energy/fatigue, attention/concentration, memory, and language; paired t tests; p ≤ 0.002). BDI-II and additional subscales also improved, at a lower level of statistical significance. Effect

  16. Randomized open-label trial of dextromethorphan in Rett syndrome.

    Science.gov (United States)

    Smith-Hicks, Constance L; Gupta, Siddharth; Ewen, Joshua B; Hong, Manisha; Kratz, Lisa; Kelley, Richard; Tierney, Elaine; Vaurio, Rebecca; Bibat, Genila; Sanyal, Abanti; Yenokyan, Gayane; Brereton, Nga; Johnston, Michael V; Naidu, Sakkubai

    2017-10-17

    To determine safety and perform a preliminary assessment of dose-dependent efficacy of dextromethorphan in normalizing electrographic spikes, clinical seizures, and behavioral and cognitive functions in girls with Rett syndrome. We used a prospective randomized, open-label trial in fast metabolizers of dextromethorphan to examine the effect of dextromethorphan on core clinical features of Rett syndrome. Interictal spike activity and clinical seizures were determined using EEG and parent reporting. Cognitive data were obtained using the Mullen Scales of Early Learning and Vineland Adaptive Behavior Scales, while behavioral data were obtained from parent-completed checklists, the Aberrant Behavior Checklist-Community Version, and the Screen for Social Interaction. Anthropometric data were obtained according to the National Health and Nutrition Examination Survey. The Rett Syndrome Severity Scale provided a clinical global impression of the effect of dextromethorphan on clinical severity. Dextromethorphan is safe for use in 3- to 15-year-old girls with Rett syndrome. Thirty-five girls were treated with 1 of 3 doses of dextromethorphan over a period of 6 months. Statistically significant dose-dependent improvements were seen in clinical seizures, receptive language, and behavioral hyperactivity. There was no significant improvement in global clinical severity as measured by the Rett Syndrome Severity Scale. Dextromethorphan is a potent noncompetitive antagonist of the NMDA receptor channel that is safe for use in young girls with Rett syndrome. Preliminary evidence suggests that dextromethorphan may improve some core features of Rett syndrome. This study provides Class IV evidence that dextromethorphan at various doses does not change EEG spike counts over 6 months, though precision was limited to exclude an important effect. © 2017 American Academy of Neurology.

  17. Spectroscopic follow up of Kepler planet candidates

    DEFF Research Database (Denmark)

    Latham..[], D. W.; Cochran, W. D.; Marcy, G.W.

    2010-01-01

    Spectroscopic follow-up observations play a crucial role in the confirmation and characterization of transiting planet candidates identified by Kepler. The most challenging part of this work is the determination of radial velocities with a precision approaching 1 m/s in order to derive masses from...... spectroscopic orbits. The most precious resource for this work is HIRES on Keck I, to be joined by HARPS-North on the William Herschel Telescope when that new spectrometer comes on line in two years. Because a large fraction of the planet candidates are in fact stellar systems involving eclipsing stars...... and not planets, our strategy is to start with reconnaissance spectroscopy using smaller telescopes, to sort out and reject as many of the false positives as possible before going to Keck. During the first Kepler observing season in 2009, more than 100 nights of telescope time were allocated for this work, using...

  18. Long-term follow-up of psilocybin-facilitated smoking cessation.

    Science.gov (United States)

    Johnson, Matthew W; Garcia-Romeu, Albert; Griffiths, Roland R

    2017-01-01

    A recent open-label pilot study (N = 15) found that two to three moderate to high doses (20 and 30 mg/70 kg) of the serotonin 2A receptor agonist, psilocybin, in combination with cognitive behavioral therapy (CBT) for smoking cessation, resulted in substantially higher 6-month smoking abstinence rates than are typically observed with other medications or CBT alone. To assess long-term effects of a psilocybin-facilitated smoking cessation program at ≥12 months after psilocybin administration. The present report describes biologically verified smoking abstinence outcomes of the previous pilot study at ≥12 months, and related data on subjective effects of psilocybin. All 15 participants completed a 12-month follow-up, and 12 (80%) returned for a long-term (≥16 months) follow-up, with a mean interval of 30 months (range = 16-57 months) between target-quit date (i.e., first psilocybin session) and long-term follow-up. At 12-month follow-up, 10 participants (67%) were confirmed as smoking abstinent. At long-term follow-up, nine participants (60%) were confirmed as smoking abstinent. At 12-month follow-up 13 participants (86.7%) rated their psilocybin experiences among the five most personally meaningful and spiritually significant experiences of their lives. These results suggest that in the context of a structured treatment program, psilocybin holds considerable promise in promoting long-term smoking abstinence. The present study adds to recent and historical evidence suggesting high success rates when using classic psychedelics in the treatment of addiction. Further research investigating psilocybin-facilitated treatment of substance use disorders is warranted.

  19. Morbidity follow-up feasibility study

    International Nuclear Information System (INIS)

    Carpenter, M.

    1988-02-01

    The report reviews the available sources of data within Canada for undertaking morbidity follow-up studies to both supplement and complement studies using Canadian mortality data. Such studies would permit earlier detection and more sensitive measures of differences in risk for exposures to radiation and allow timely measures to be taken to minimize any occupational and environmental health risk to radiation workers. The technical feasibility of using these sources was reviewed using the criteria of adequate personal identifying information, automation of data records, file size and the accuracy of the morbidity diagnosis information. At the present time certain of the provincial cancer registry files meet these criteria best. A work plan was prepared suggesting a morbidity pilot study to clarify the role of occupational factors in the incidence of cancer among radiation workers using the Alberta Cancer Registry file and the National Dose Registry (NDR) file of radiation workers. For the longer term a full cohort study using the National Cancer Incidence Reporting System (NCIRS) and the NDR workers as the study population would provide information on all radiation workers on a national basis. A work plan was prepared and some initial format conversion of historical data was undertaken to begin developing the NCIRS into a data base suitable for long-term health studies

  20. Therapeutic abortion follow-up study.

    Science.gov (United States)

    Margolis, A J; Davison, L A; Hanson, K H; Loos, S A; Mikkelsen, C M

    1971-05-15

    To determine the long-range psychological effects of therapeutic abortion, 50 women (aged from 13-44 years), who were granted abortions between 1967 and 1968 Because of possible impairment of mental and/or physical health, were analyzed by use of demographic questionnaires, psychological tests, and interviews. Testing revealed that 44 women had psychiatric problems at time of abortion. 43 patients were followed for 3-6 months. The follow-up interviews revealed that 29 patients reacted positively after abortion, 10 reported no significant change and 4 reacted negatively. 37 would definitely repeat the abortion. Women under 21 years of age felt substantially more ambivalent and guilty than older patients. A study of 36 paired pre- and post-abortion profiles showed that 15 initially abnormal tests had become normal. There was a significant increase in contraceptive use among the patients after the abortion, but 4 again became pregnant and 8 were apparently without consistent contraception. It is concluded that the abortions were therapeutic, but physicians are encouraged to be aware of psychological problems in abortion cases. Strong psychological and contraceptive counselling should be exercised.

  1. Colon neoplasms. Postoperative follow-up

    International Nuclear Information System (INIS)

    Galano Urgelles, Rolando; Rodriguez Fernandez, Zenen; Casaus Prieto, Arbelio

    1997-01-01

    A longitudinal and prospective study of 69 patients operated on for colon cancer was carried out during 6 years. Patients Webre folloWebd-up for the purpose of the study. The analysis evidenced that the most frequent age group ranged betWeben 65 and 74 years and that there was a predominance of females, as Webll as of stages II and III b and groups BI and BII according to Dukes' classification. Certain relapses resulting in re operations Webre detected. 5-fluoracil was used as a therapeutic agent, while the highest survival rate was attained in patients presenting with tumors in 0, I, II, and III a stages from groups A, BI, and CI of Dukes, or in those who complied with the cytostatic treatment. Survival outcomes Webre higher than the ones reported. Recommendations include to encourage mass screening in those risk groups at primary care level in order to detect early the entity, and thus improve the surgical outcomes and the results of postoperative follow-up

  2. The Effect of Medicinal Cannabis on Pain and Quality-of-Life Outcomes in Chronic Pain: A Prospective Open-label Study.

    Science.gov (United States)

    Haroutounian, Simon; Ratz, Yael; Ginosar, Yehuda; Furmanov, Karina; Saifi, Fayez; Meidan, Ronit; Davidson, Elyad

    2016-12-01

    The objective of this prospective, open-label study was to determine the long-term effect of medicinal cannabis treatment on pain and functional outcomes in participants with treatment-resistant chronic pain. The primary outcome was the change in the pain symptom score on the S-TOPS (Treatment Outcomes in Pain Survey-Short Form) questionnaire at the 6-month follow-up in an intent-to-treat population. Secondary outcomes included the change in S-TOPS physical, social, and emotional disability scales, the pain severity, and pain interference on the Brief Pain Inventory, sleep problems, and the change in opioid consumption. A total of 274 participants were approved for treatment; complete baseline data were available for 206 (intent-to-treat), and complete follow-up data for 176 participants. At follow-up, the pain symptom score improved from median 83.3 (95% confidence interval [CI], 79.2-87.5) to 75.0 (95% CI, 70.8-79.2) (Pmedicinal cannabis in this open-label, prospective cohort resulted in improved pain and functional outcomes, and a significant reduction in opioid use. Results suggest long-term benefit of cannabis treatment in this group of patients, but the study's noncontrolled nature should be considered when extrapolating the results.

  3. Follow-up radiological surveillance, Marshall Islands

    International Nuclear Information System (INIS)

    Greenhouse, N.A.

    1978-01-01

    The political approvals have been given for the return of Bikini and Enewetak Atolls to their original inhabitants. These two regions, which comprised the Pacific Nuclear Testing Areas from 1946 to 1958, are now being repopulated by their original inhabitants and their families. Recent assessments of internal and external exposure pathways at Bikini and Enewetak have indicated that doses and dose commitments in excess of current radiation protection guidelines are possible or even likely for persons living in these areas. Rongelap and Utirik Atolls, which were downwind of the 1954 Bravo event, also received significant fallout; potential radiological problems exist in these areas as well. In view of this prospect, follow-up environmental monitoring and personnel monitoring programs are being established to maintain our cognizance of radiological conditions, and to make corrective action where necessary. The unexpected finding of detectable amounts (above background) of plutonium in the urine of individuals at Bikini and Rongelap Atolls also raises the possibility of radiological problems in the long term from environmentally-derived plutonium via pathways which are not completely understood. This finding adds further impetus to the surveillance programs for an area where real radiological concerns for the general public are already known to exist. The continuing environmental and personnel monitoring programs which this paper describes are a necessary part of the BNL radiological safety program in the Marshall Islands, which is designed to do the following: (1) elucidate the internal exposure pathways; (2) define the external radiation environment; (3) assess the doses and dose commitments from radioactivity in the environment; (4) provide the feedback necessary to improve existing predictive modelling of radiological trends; and (5) suggest actions which will minimize doses via the more significant pathways. (author)

  4. Electroconvulsive therapy for the treatment of clozapine nonresponders suffering from schizophrenia--an open label study

    NARCIS (Netherlands)

    Kho, K. H.; Blansjaar, B. A.; de Vries, S.; Babuskova, D.; Zwinderman, A. H.; Linszen, D. H.

    2004-01-01

    OBJECTIVE: This open label study describes the efficacy of electroconvulsive therapy (ECT) as adjunctive treatment in clozapine nonresponders suffering from schizophrenia. METHOD: The results of clozapine and ECT treatment in 11 clozapine nonresponders suffering from schizophrenia are reported in

  5. Open-label extension studies: do they provide meaningful information on the safety of new drugs?

    Science.gov (United States)

    Day, Richard O; Williams, Kenneth M

    2007-01-01

    The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. If undertaken primarily to gather more patient-years of exposure to the new drug in order to understand and gain confidence in its safety profile, open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this can only occur if the open-label extension study is designed, executed, analysed and reported competently. Most of the value accrued in open-label extension studies is gained from a refinement in the perception of the expected incidence of adverse effects that have most likely already been identified as part of the preclinical and clinical trial programme. We still have to rely heavily on post-marketing safety surveillance systems to alert us to type B (unpredictable) adverse reactions because open-label extension studies are unlikely to provide useful information about these types of often serious and relatively rare adverse reactions. Random allocation into test and control groups is needed to produce precise incidence data on pharmacologically expected, or type A, adverse effects. Some increased confidence about incidence rates might result from the open-label extension study; however, as these studies are essentially uncontrolled and biased, the data are not of great value. Other benefits have been proposed to be gained from open-label extension studies. These include ongoing access to an effective but otherwise unobtainable medicine by the volunteers who participated in the phase III pivotal trials. However, there are unappreciated ethical issues about the appropriateness of enrolling patients whose response to previous treatment is uncertain, largely because treatment allocation in the preceding randomised, double-blind, controlled trial has not been revealed at the

  6. Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study.

    Science.gov (United States)

    Carhart-Harris, Robin L; Bolstridge, Mark; Rucker, James; Day, Camilla M J; Erritzoe, David; Kaelen, Mendel; Bloomfield, Michael; Rickard, James A; Forbes, Ben; Feilding, Amanda; Taylor, David; Pilling, Steve; Curran, Valerie H; Nutt, David J

    2016-07-01

    Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species. Recent studies have assessed the therapeutic potential of psilocybin for various conditions, including end-of-life anxiety, obsessive-compulsive disorder, and smoking and alcohol dependence, with promising preliminary results. Here, we aimed to investigate the feasibility, safety, and efficacy of psilocybin in patients with unipolar treatment-resistant depression. In this open-label feasibility trial, 12 patients (six men, six women) with moderate-to-severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 mg and 25 mg, 7 days apart) in a supportive setting. There was no control group. Psychological support was provided before, during, and after each session. The primary outcome measure for feasibility was patient-reported intensity of psilocybin's effects. Patients were monitored for adverse reactions during the dosing sessions and subsequent clinic and remote follow-up. Depressive symptoms were assessed with standard assessments from 1 week to 3 months after treatment, with the 16-item Quick Inventory of Depressive Symptoms (QIDS) serving as the primary efficacy outcome. This trial is registered with ISRCTN, number ISRCTN14426797. Psilocybin's acute psychedelic effects typically became detectable 30-60 min after dosing, peaked 2-3 h after dosing, and subsided to negligible levels at least 6 h after dosing. Mean self-rated intensity (on a 0-1 scale) was 0·51 (SD 0·36) for the low-dose session and 0·75 (SD 0·27) for the high-dose session. Psilocybin was well tolerated by all of the patients, and no serious or unexpected adverse events occurred. The adverse reactions we noted were transient anxiety during drug onset (all patients), transient confusion or thought disorder (nine patients), mild and transient nausea (four patients), and transient headache (four patients). Relative to baseline, depressive symptoms were markedly reduced 1

  7. Meeting increased demand for total knee replacement and follow-up: determining optimal follow-up.

    Science.gov (United States)

    Meding, J B; Ritter, M A; Davis, K E; Farris, A

    2013-11-01

    The strain on clinic and surgeon resources resulting from a rise in demand for total knee replacement (TKR) requires reconsideration of when and how often patients need to be seen for follow-up. Surgeons will otherwise require increased paramedical staff or need to limit the number of TKRs they undertake. We reviewed the outcome data of 16 414 primary TKRs undertaken at our centre to determine the time to re-operation for any reason and for specific failure mechanisms. Peak risk years for failure were determined by comparing the conditional probability of failure, the number of failures divided by the total number of TKRs cases, for each year. The median times to failure for the most common failure mechanisms were 4.9 years (interquartile range (IQR) 1.7 to 10.7) for femoral and tibial loosening, 1.9 years (IQR 0.8 to 3.9) for infection, 3.1 years (IQR 1.6 to 5.5) for tibial collapse and 5.6 years (IQR 3.4 to 9.3) for instability. The median time to failure for all revisions was 3.3 years (IQR 1.2 to 8.5), with an overall revision rate of 1.7% (n = 282). Results from our patient population suggest that patients be seen for follow-up at six months, one year, three years, eight years, 12 years, and every five years thereafter. Patients with higher pain in the early post-operative period or high body mass index (≥ 41 kg/m(2)) should be monitored more closely.

  8. Methylphenidate Transdermal System in Adults with Past Stimulant Misuse: An Open-Label Trial

    Science.gov (United States)

    McRae-Clark, Aimee L.; Brady, Kathleen T.; Hartwell, Karen J.; White, Kathleen; Carter, Rickey E.

    2011-01-01

    Objective: This 8-week, open-label trial assessed the efficacy of methylphenidate transdermal system (MTS) in 14 adult individuals diagnosed with ADHD and with a history of stimulant misuse, abuse, or dependence. Method: The primary efficacy endpoint was the Wender-Reimherr Adult ADHD Scale (WRAADS), and secondary efficacy endpoints included the…

  9. An open-label Optional Titration Trial to Evaluate the Efficacy ...

    African Journals Online (AJOL)

    An eight-week open-label optional titration trial to evaluate the efficacy, tolerability and safety of Valsartan 80 mg/ & 160 mg once daily was carried out in patients with mild to moderate essential hypertension at the Lagos University Teaching Hospital. There was a significant reduction in both systolic and diastolic blood ...

  10. Open-Label Trial of Atomoxetine Hydrochloride in Adults with ADHD

    Science.gov (United States)

    Johnson, Mats; Cederlund, Mats; Rastam, Maria; Areskoug, Bjorn; Gillberg, Christopher

    2010-01-01

    Background: While atomoxetine is an established treatment for attention-deficit/hyperactivity disorder in children, few studies have examined its efficacy for adults. Methods: Open-label trial of atomoxetine in 20 individuals with ADHD, aged 19-47 years, for 10 weeks, and a total of one year for responders. Results: Ten patients met primary…

  11. An Open-Label Trial of Escitalopram in Pervasive Developmental Disorders.

    Science.gov (United States)

    Owley, Thomas; Walton, Laura; Salt, Jeff; Guter, Stephen J., Jr.; Winnega, Marrea; Leventhal, Bennett L.; Cook, Edwin H., Jr.

    2005-01-01

    Objective: To assess the effect of escitalopram in the treatment of pervasive developmental disorders (PDDs). Method: This 10-week study had a forced titration, open-label design. Twenty-eight subjects (mean age 125.1 [+ or -] 33.5 months) with a PDD received escitalopram at a dose that increased weekly to a maximum dose of 20 mg as tolerated. The…

  12. Safety of telmisartan in patients with arterial hypertension - An open-label observational study

    NARCIS (Netherlands)

    Michel, Martin C.; Bohner, Herbert; Köster, Jürgen; Schäfers, Rafael; Heemann, Uwe

    2004-01-01

    Objective: To determine whether age, gender, concomitant disease and/or previous or present antihypertensive medication affect the safety or antihypertensive efficacy of telmisartan in the treatment of arterial hypertension. Study Design and Methods: In this large-scale, open-label postmarketing

  13. The value of gynecologic cancer follow-up

    DEFF Research Database (Denmark)

    Lajer, Henrik; Jensen, Mette B.; Kilsmark, Jannie

    2010-01-01

    that follow-up affects the women's quality of life. CONCLUSIONS:: The main purpose of follow-up after treatment of cancer is improved survival. Our review of the literature showed no evidence of a positive effect on survival in women followed up after primary treatment of endometrial or ovarian cancer......INTRODUCTION:: To explore the extent of evidence-based data and cost-utility of follow-up after primary treatment of endometrial and ovarian cancer, addressing perspectives of technology, organization, economics, and patients. METHODS:: Systematic literature searches according......:: None of the identified studies supported a survival benefit from hospital-based follow-up after completion of primary treatment of endometrial or ovarian cancer. The methods for follow-up were of low technology (gynecologic examination with or without ultrasound examination). Other technologies had...

  14. Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rickard Kristen

    2011-03-01

    Full Text Available Abstract Background Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth. Methods We used a prospective, randomized, open-label, blinded-endpoint (PROBE study design. Pregnant women presenting at Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg or usual care (screening result is not revealed, no treatment. The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth Results Of 779 women approached, 500 (64% participated in candidiasis screening, and 98 (19.6% had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03. Conclusions A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12609001052224

  15. 29 CFR 99.315 - Audit findings follow-up.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Audit findings follow-up. 99.315 Section 99.315 Labor Office... § 99.315 Audit findings follow-up. (a) General. The auditee is responsible for follow-up and corrective... include the reference numbers the auditor assigns to audit findings under § 99.510(c). Since the summary...

  16. Gegen sexismus- Gegen Rassismus. Two months after Colonia night

    Directory of Open Access Journals (Sweden)

    Laura Guidi

    2016-03-01

    Full Text Available Two months later the thefts and sexual assaults on women carried out by groups of men in the German city of Cologne on New Year’s Eve, the article focuses on the Media debate about the subject: from the Islamophobic interpretations to the opinions expressed by both Western and Islamic feminists.

  17. Sweat gland carcinoma in a two-month old child

    International Nuclear Information System (INIS)

    Andrea, M.L.M. de; Antoneli, C.B.G.; Novaes, P.E.R.S.; Saba, L.M.; Bianchi, A.

    1982-01-01

    A case is presented of a two-month old child, female, with a sweat gland carcinoma of the left palm. The rarity of this tumor in this age is commented and the national and international literature are reviewed. It is concluded that this is probably the first case in the age group. (M.A.) [pt

  18. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study

    DEFF Research Database (Denmark)

    Chartier-Kastler, E; Lauge, I; Ruffion, A

    2011-01-01

    Self-catheterising males aged ≥18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial.......Self-catheterising males aged ≥18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial....

  19. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study

    DEFF Research Database (Denmark)

    Chartier-Kastler, E; Lauge, I; Ruffion, A

    2011-01-01

    Self-catheterising males aged =18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial.......Self-catheterising males aged =18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial....

  20. National screening program vs. standardized neurodevelopmental follow-up

    NARCIS (Netherlands)

    Maschke, Cornelia; Ellenrieder, Birte; Hecher, Kurt; Bartmann, Peter

    Background: Long-term follow-up is urgently needed to decide on the consequences of new therapies. Objective: This study assesses the use of a national child development screening program for a follow-up examination of a defined patient group. Patients and methods: Neurodevelopmental outcome of 139

  1. Carcinoembryonic Antigen (CEA) in colorectal cancer follow-up

    NARCIS (Netherlands)

    Verberne, Charlotte

    2016-01-01

    Colorectal cancer follow-up aims to detect recurrent disease as soon as possible, since earlier detection of recurrent disease is associated with greater chances for cure. A part of follow-up is the measurement of Carcinoembryonic Antigen (CEA) in the blood of the patient. This tumor marker is

  2. The follow-up time issue on small roundabouts

    Directory of Open Access Journals (Sweden)

    Janusz WOCH

    2008-01-01

    Full Text Available The follow-up time was investigated. The aim of this analysis was to create a formula that allows the follow-up time calculated using the most important external parameters. The studies were based on empirical data collected at small roundabouts localized on Upper Silesia. The follow-up time is the average time gap between two cars of the minor stream being queued and entered the same major stream gap one behind the other. Follow-up times were measured directly by observing traffic flow. Resulting follow-up times were analyzed to determine their dependence on parameters such as intersection layout, roundabouts diameter and left visibility. These parameters were tested using the conventional calculation method (regression analysis. The dependence of follow-up time was then integrated into the own capacity estimation method for small roundabouts localized on urban areas. One of the biggest advantages this dependence is that capacity and traffic flow on small roundabouts can be determined reliably and appropriately for actual situations. The new follow-up time values for all range of external diameters of small roundabout 26 (22 – 40 m have been presented in this article.

  3. CLINICAL OUTCOMES AND SELF-REPORTED SYMPTOMS IN PATIENTS WITH ACROMEGALY: AN 8-YEAR FOLLOW-UP OF A LANREOTIDE STUDY.

    Science.gov (United States)

    Khairi, Shafaq; Sagvand, Babak Torabi; Pulaski-Liebert, Karen J; Tritos, Nicholas A; Klibanski, Anne; Nachtigall, Lisa B

    2017-01-01

    The aim of this study was to evaluate the proportion of patients with acromegaly who remained on long-term lanreotide depot after completion of an open-label multicenter phase III clinical trial (SALSA: A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel), compare baseline and long-term follow-up symptoms scores, and correlate scores with individual longitudinal clinical outcomes. Records of all subjects previously enrolled at the Massachusetts General Hospital site of SALSA were reviewed. Those who remained on lanreotide were interviewed and asked to complete a questionnaire that they had filled out in SALSA in 2007 regarding their current symptomatology and injection side effects, as well as to complete the Acromegaly Quality of Life Questionnaire. Furthermore, clinical, biochemical, and radiographic data related to acromegaly and its comorbidities were tracked throughout follow-up. Six out of 7 patients chose to remain on lanreotide, and 5 of them continued lanreotide depot through last follow-up, for up to 8 years or in 1 case until death. In all cases, lanreotide remained well tolerated, and insulin-like growth factor-1 levels and pituitary imaging remained well controlled on stable doses. While comorbidities persisted or developed, the self-reported symptom score after up to 8 years of therapy showed a significant decrease in frequency or resolution in symptoms that were reported at baseline. This study shows a significant decrease in frequency or resolution in self-reported symptoms in well-controlled patients receiving long-term lanreotide therapy. AcroQoL = Acromegaly Quality of Life Questionnaire GH = growth hormone GI = gastrointestinal IGF-1 = insulin-like growth factor-1 SALSA = A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel.

  4. The Danish Cerebral Palsy Follow-up Program

    DEFF Research Database (Denmark)

    Rasmussen, Helle Mätzke; Nordbye-Nielsen, Kirsten; Møller-Madsen, Bjarne

    2016-01-01

    AIM OF DATABASE: The Danish Cerebral Palsy Follow-up Program is a combined follow-up program and national clinical quality database that aims to monitor and improve the quality of health care for children with cerebral palsy (CP). STUDY POPULATION: The database includes children with CP aged 0...... indicators in three of five regions in Denmark comprising 432 children with CP, corresponding to a coverage of 82% of the expected population. CONCLUSION: The Danish Cerebral Palsy Follow-up Program is currently under development as a national clinical quality database in Denmark. The database holds...

  5. The Effects of Individual Upper Alpha Neurofeedback in ADHD: An Open-Label Pilot Study

    OpenAIRE

    Escolano , Carlos; Navarro-Gil , Mayte; Garcia-Campayo , Javier; Congedo , Marco; Minguez , Javier

    2014-01-01

    International audience; Standardized neurofeedback (NF) protocols have been extensively evaluated in attention-deficit/hyperactivity disorder (ADHD). However, such protocols do not account for the large EEG heterogeneity in ADHD. Thus, individualized approaches have been suggested to improve the clinical outcome. In this direction, an open-label pilot study was designed to evaluate a NF protocol of relative upper alpha power enhancement in fronto-central sites. Upper alpha band was individual...

  6. Follow-up Medical Care After Cancer Treatment

    Science.gov (United States)

    ... Data Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Questions to Ask About Cancer Research Follow-Up Medical Care Once you’re done with cancer treatment, ...

  7. Post-Discharge Follow-Up Visits and Hospital Utilization

    Data.gov (United States)

    U.S. Department of Health & Human Services — Analysis reported in Post-Discharge Follow-Up Visits and Hospital Utilization by Medicare Patients, 2007-2010, published in Volume 4, Issue 2 of Medicare and...

  8. N-Acetylcysteine for Nonsuicidal Self-Injurious Behavior in Adolescents: An Open-Label Pilot Study.

    Science.gov (United States)

    Cullen, Kathryn R; Klimes-Dougan, Bonnie; Westlund Schreiner, Melinda; Carstedt, Patricia; Marka, Nicholas; Nelson, Katharine; Miller, Michael J; Reigstad, Kristina; Westervelt, Ana; Gunlicks-Stoessel, Meredith; Eberly, Lynn E

    2018-03-01

    Nonsuicidal self-injury (NSSI) is common in adolescents and young adults, and few evidence-based treatments are available for this significant problem. N-acetylcysteine (NAC) is a widely available nutritional supplement that has been studied in some psychiatric disorders relevant to NSSI including mood and addictive disorders. This pilot study tested the use of NAC as a potential treatment for NSSI in youth. Thirty-five female adolescents and young adults with NSSI aged 13-21 years were enrolled in this study that had an open-label, single-arm study design. All participants were given oral NAC as follows: 600 mg twice daily (weeks 1-2), 1200 mg twice daily (weeks 3-4), and 1800 mg twice daily (weeks 5-8). Patients were seen every 2 weeks throughout the trial, at which time youth reported the frequency of NSSI episodes. Levels of depression, impulsivity, and global psychopathology were measured at baseline and at the end of the trial using the Beck Depression Inventory-II (BDI-II), Barratt Impulsivity Scale, and Symptoms Checklist-90 (SCL-90). About two-thirds of the enrolled female youth completed the trial (24/35). NAC was generally well tolerated in this sample. NAC treatment was associated with a significant decrease in NSSI frequency at visit 6 and visit 8 compared to baseline. We also found that depression scores and global psychopathology scores (but not impulsivity scores) decreased after NAC treatment. Decrease in NSSI was not correlated with decrease in BDI-II or SCL-90 scores, suggesting these might be independent effects. We provide preliminary evidence that NAC may have promise as a potential treatment option for adolescents with NSSI. The current results require follow-up with a randomized, placebo-controlled trial to confirm efficacy.

  9. Effect of thread embedding acupuncture for facial wrinkles and laxity: a single-arm, prospective, open-label study

    Directory of Open Access Journals (Sweden)

    Younghee Yun

    2017-12-01

    Full Text Available Background: There is a growing trend for patients to seek the least invasive treatments with less risk of complications and downtime for facial rejuvenation. Thread embedding acupuncture has become popular as a minimally invasive treatment. However, there is little clinical evidence in the literature regarding its effects. Methods: This single-arm, prospective, open-label study recruited participants who were women aged 40–59 years, with Glogau photoaging scale III–IV. Fourteen participants received thread embedding acupuncture one time and were measured before and after 1 week from the procedure. The primary outcome was a jowl to subnasale vertical distance. The secondary outcomes were facial wrinkle distances, global esthetic improvement scale, Alexiades–Armenakas laxity scale, and patient-oriented self-assessment scale. Results: Fourteen participants underwent thread embedding acupuncture alone, and 12 participants revisited for follow-up outcome measures. For the primary outcome measure, both jowls were elevated in vertical height by 1.87 mm (left and 1.43 mm (right. Distances of both melolabial and nasolabial folds showed significant improvement. In the Alexiades–Armenakas laxity scale, each evaluator evaluated for four and nine participants by 0.5 grades improved. In the global aesthetic improvement scale, improvement was graded as 1 and 2 in nine and five cases, respectively. The most common adverse events were mild bruising, swelling, and pain. However, adverse events occurred, although mostly minor and of short duration. Conclusion: In this study, thread embedding acupuncture showed clinical potential for facial wrinkles and laxity. However, further large-scale trials with a controlled design and objective measurements are needed. Keywords: polydioxanone, rejuvenation, rhytidoplasty, skin aging, thread embedding acupuncture

  10. High-dose nifuratel for simple and mixed aerobic vaginitis: A single-center prospective open-label cohort study.

    Science.gov (United States)

    Liang, Qian; Li, Nan; Song, Shurong; Zhang, Aihua; Li, Ni; Duan, Ying

    2016-10-01

    The efficacy and safety of two nifuratel dosages for the treatment of aerobic vaginitis (AV) were compared. This was a prospective open-label cohort study of patients diagnosed and treated at the Tianjin Third Central Hospital between January 2012 and December 2013. The co-presence of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or/and trichomonal vaginitis (TV; mixed AV) was determined. Patients were randomized to nifuratel-500 (500 mg nifuratel, intravaginal, 10 days) or nifuratel-250 (250 mg nifuratel, intravaginal, 10 days), and followed-up for three to seven days after treatment completion. Primary and secondary outcomes were recovery rate and adverse events, respectively. The study included 142 patients with AV. Age was not significantly different between the groups (n = 71 each), and disease distribution was identical: 29 (40.85%) simple AV and 42 (59.15%) mixed AV (AV + BV, 42.86 %; AV + VVC, 30.95%; AV + TV, 26.19%). In patients with simple AV, the recovery rate did not differ significantly between the nifuratel-500 (26/29, 89.66%) and nifuratel-250 (22/29, 75.86%) groups. In patients with mixed AV, recovery rates were significantly higher in the nifuratel-500 than in the nifuratel-250 group (AV + BV, 88.89% vs 50.00 %; AV + VVC, 76.92 % vs 30.77 %; AV + TV, 90.91 % vs 36.36%; all P < 0.05). Only one patient (nifuratel-500) reported an adverse event (mild anaphylactic reaction). Nifuratel 500 mg showed good clinical efficacy for the treatment of AV, particularly mixed AV, and is superior to the 250 mg dosage in the treatment of mixed AV. © 2016 Japan Society of Obstetrics and Gynecology.

  11. Internet of things and bariatric surgery follow-up: Comparative study of standard and IoT follow-up.

    Science.gov (United States)

    Vilallonga, Ramon; Lecube, Albert; Fort, José Manuel; Boleko, Maria Angeles; Hidalgo, Marta; Armengol, Manel

    2013-09-01

    Follow-up of obese patient is difficult. There is no literature related to patient follow-up that incorporates the concept of Internet of Things (IoT), use of WiFi, Internet, or portable devices for this purpose. This prospective observational study commenced in June 2011. Patients were prospectively offered to participate in the IoT study group, in which they received a WiFi scale (Withing®, Paris) that provides instant WiFi data to the patient and surgeon. Other patients were admitted to the standard follow-up group at the outpatient clinic. A total of 33 patients were included in our study (ten in the IoT group). Twelve patients did not have WiFi at home, ten lacked of computer knowledge, and seven preferred standard for follow-up. All patients underwent different surgical procedures. There were no complications. Excess weight loss (EWL) was similar in both groups. More than 90% of patients were satisfied. In the IoT group, patients considered it valuable in saving time, and considered seeing their evolution graphics extremely motivating. IoT technology can monitor medical parameters remotely and collect data. A WiFi scale can facilitate preoperative and follow-up. Standard follow-up in a classical outpatient clinic setting with the surgeon was preferred globally.

  12. Nonimaging aspects of follow-up in breast cancer reconstruction.

    Science.gov (United States)

    Wood, W C

    1991-09-01

    Follow-up of patients with breast cancer is directed to the early detection of recurrent or metastatic disease and the detection of new primary breast cancer. The survival benefit of early detection is limited to some patients with local failure or new primary tumors. That imaging is not used in follow-up of patients who have had breast cancer reconstruction is related to possible interference with this putative benefit by the reconstructive procedure. Such follow-up is accomplished by the patient's own surveillance, clinical examination, and laboratory testing supplemented by imaging studies. Clinical follow-up trials of women who have undergone breast reconstructive surgery show no evidence that locally recurrent breast carcinoma is masked when compared with follow-up of women who did not undergo reconstructive procedures. Reshaping of the contralateral breast to match the reconstructed breast introduces the possibility of interference with palpation as well as mammographic distortion in some women. This is an uncommon practical problem except when complicated by fat necrosis.

  13. Follow-up care of children suffered from burns

    Directory of Open Access Journals (Sweden)

    Konstantin Aleksandrovich Afonichev

    2015-03-01

    Full Text Available Outcomes of III-VI AB degree burns in children,regardless of the nature of treatment in the acute andrecovery period, are the development of scar contractures and deformities of the joints. However, thecorrect organization of follow-up care and rehabilitation treatment can significantly reduce the severity and facilitates the full recovery of the affected segment. Based on the analysis of their own material, the author defines the early stage of rehabilitation in these patients before full maturation of scar tissue or before the formation of functionally significant joint contractures, and later period, when there are indications for surgical rehabilitation. In the early period, follow-up care is recommended in 1 month after discharge and then on a quarterly basis, and with the appearance of deformities - at least once in 2 months. At the2nd stage of rehabilitation, older children and children of secondary school age are subject to follow-up care at least 1 time per year of primary school age - atleast once in 6 months, preschool children - every3 months. The proposed assessment of scar tissuehelps to determine the terms of follow-up care. Usingthis scheme of follow-up care and appropriate treatment allowed the author to obtain excellent and goodresults in 87-90 % of cases at the stages of rehabilitaion.

  14. Peritoneal inclusion cysts: Changes on follow-up ultrasonography

    International Nuclear Information System (INIS)

    Kim, Jung Sik; Lee, Jin Hee; Lee, Hee Jung; Lee, Sung Moon; Woo, Seong Ku

    2003-01-01

    To evaluate the volume change of peritoneal inclusion cysts on the follow-up ultrasonography (US). From March 1995 to May 1999, thirty seven women with ultrasonographically diagnosed peritoneal inclusion cysts were included in this study. Six patients underwent surgery for several reasons. Follow-up ultrasonography was performed 70-456 days (mean=191 days) after initial US examination in 12 of the remaining 31 patient with no further treatment. US was performed with a 3.5 or 4 MHz transabdominal probe in all 18 patients who underwent either surgery or follow-up US, and additional tranvaginal US examination using a 5-7 MHz probe in 15 of 18 patients. The volume change of the cysts was recorded for each US examination. Three cysts (25%) (volume=170 cm 3 , 61 cm 3 , and 38 cm 3 , respectively) were completely resolved on the follow-up US while the other nine cysts showed a decreased volume in seven patients (58%) and increased volume in two patients (17%). Spontaneous regression of peritoneal inclusion cysts is more common than it is believed to be, and ultrasonography may be a useful follow-up examination for peritoneal inclusion cysts.

  15. Course of disease and follow-up in breast cancer

    International Nuclear Information System (INIS)

    Ebner, F.; Hackl, H.; Hoermann, M.; Schneider, G.

    1986-01-01

    Besides individual care, regular follow-up studies in breast cancer patients have different aims, relative to different tumor stages at presentation. In early stages emphasis has to be laid on detection of loco-regional recurrences, which will not reduce overall survival if diagnosed and treated early. In addition, treatment effects and changes in the activity of disease are evaluated. Radiographic studies for detection of distant metastases are justified if followed by proper treatment. Early diagnosis of cancer of the opposite breast and of such cancers that are associated with breast cancer (colon, ovaries, endometrium) is imperative. The aim of a regular follow-up in more advanced tumor stages is to monitor the extent of disease and to prevent complications (e.g. fractures, spinal cord compression). In familial breast cancer first degree relatives should be included in the follow-up plan. The patient's psychosocial needs, even if not verbalized, should not be neglected. (Author)

  16. Follow up of Graves' Opthalmopathy after radioiodine therapy

    International Nuclear Information System (INIS)

    Miah, M.S.R.; Paul, A. K.; Rahman, H.A.

    2002-01-01

    Graves' ophthalmopathy may first appear or worsen during or after treatment for hyperthyroidism. We followed up 158 Graves' hyperthyroid patients treated with radioiodine of which 49 had Grave's' ophthalmopathy during presentation in Nuclear Medicine Centre, Khulna during the period from 1995 to 2000. The aim of our study is to see the effect of radioiodine in Graves' ophthalmopathy. All the patients received radioiodine at fixed dose regime ranged from 7 mCi to 12 mCi. The duration of follow up was at least 12 months Graves' ophthalmopathy patients, 4 (4/49 i.e., 8.2%) showed exaggeration of ophthalmopathy and the rest (45/49 i.e., 91.8%) remained unchanged. None of ophthalmopathy developed among any of Graves' hyperthyroid or disappeared after radioiodine treatment during follow up period. From the study we concluded that eye changes in Graves' hyperthyroidism remain unchanged or exaggerated after radioiodine therapy and needs ophthalmologist care.(author)

  17. Esophageal atresia: long-term interdisciplinary follow-up

    Directory of Open Access Journals (Sweden)

    Lidia B. Giúdici

    2016-07-01

    Full Text Available Background: We provide protocolized interdisciplinary follow-up to babies born with Esophageal Atresia (EA. There are few reports in Argentina about follow-up of EA patients.Objective: To describe outcomes in follow-up of EA patients at 1, 3 and 6 years old and to compare outcomes at age 1 with those at age 6.Methods: Prospective, longitudinal, analytic study of the cohort of babies born with EA, admitted to the follow-up program from 11/01/03 to 10/31/14. Follow-up includes: growth (weight > 10th centile, WHO, neurology-psychomotor development, audiology, vision, genetic, mental health, surgical reintervention, phonostomatology, language, pulmonology, re-hospitalization for clinical causes, lost to follow-up. Outcomes were described at age 1, 3 and 6. We included all EA patients who had reached age 1 at the start of this study.Results: 27 babies were admitted; 30% had long-gap EA; 18% presented VACTERL association; 23 children met inclusion criteria. Genetics  was assessed in 18 newborns (78%; a chromosomal map was performed in 11 babies; 3 had an abnormal karyotype. Mental health: 5/14 of the assessed children showed problems. Phonostomatology: 11 newborns checked (6 required treatment, 4 recovered at age 1. Pulmonologist evaluated 18 babies (7 with recurrent wheezing, 6 with moderate tracheomalacia. Gastroenterology and endoscopy: 80% presented gastroesophageal reflux (GER grade 3-4, and 50% showed a pathologic pHmetry. Lost to follow-up: age 1, 2 (8%; age 3, 3 (17%; age 6, 3 (23%. Normal outcomes observed are the following. Age 1 – growth: 81%; neurologic-psychomotor developmental index (NPDI: 76%; audiology: 95%; vision: 85%; language: 62%; re-hospitalization for clinical causes: 38%; surgical reinterventions: 47%. Age 3 – growth: 78%; NPDI: 50%; audiology: 93%; vision: 93%; language: 43%; re-hospitalization: 35%; surgical reinterventions: 14%. Age 6 – growth: 50%; NPDI: 30%; audiology: 90%; vision: 40%; language: 50%; re

  18. Exercise-Induced Ventricular Fibrillation: Seven Years Follow-Up

    Directory of Open Access Journals (Sweden)

    Gökmen Gemici

    2011-11-01

    Full Text Available We present a 7-year follow-up of a 55-year-old male who experienced ventricular fibrillation during the recovery period of exercise testing and refused implantation of an ICD. Normal left ventricular systolic function was found on echocardiographic examination, and coronary angiography revealed only a side branch disease with a vessel diameter of less than 2 millimeters. The patient was discharged on metoprolol and ASA in addition to his previous treatment with lisinopril and simvastatin. Outpatient cardiac evaluation by repeated 24-hour ECG monitorizations (Holter revealed normal findings. On follow up visits every six months for the past seven years, the patient was found to be asymptomatic.

  19. Group anxiety management: effectiveness, perceived helpfulness and follow-up.

    Science.gov (United States)

    Cadbury, S; Childs-Clark, A; Sandhu, S

    1990-05-01

    An evaluation was conducted on out-patient cognitive-behavioural anxiety management groups. Twenty-nine clients assessed before and after the group and at three-month follow-up showed significant improvement on self-report measures. A further follow-up on 21 clients, conducted by an independent assessor at an average of 11 months, showed greater improvement with time. Clients also rated how helpful they had found non-specific therapeutic factors, and specific anxiety management techniques. 'Universality' was the most helpful non-specific factor, and 'the explanation of anxiety' was the most helpful technique.

  20. Barrett's esophagus. Diagnosis, follow-up and treatment

    DEFF Research Database (Denmark)

    Bremholm, Lasse; Funch-Jensen, Peter; Eriksen, Jan

    2012-01-01

    gastroesophageal junction. The extent of the endoscopic findings is described by the Prague classification. The metaplasia is histologically confirmed by the presence of intestinal metaplasia. The diagnosis of BE can only be made by a combined macroscopic and microscopic examination. The histological description...... and it is not recommended outside controlled studies. Treatment of high grade dysplasia and carcinoma in situ is handled in departments treating esophageal cancer. Follow-up with endoscopy and biopsy can be offered. Follow-up endoscopy with biopsy can only be recommended after thorough information to the patients...

  1. Danish offshore wind. Key environmental issues - a follow-up

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-02-15

    This follow-up to the Danish environmental monitoring programme on large-scale offshore wind power builds on the result of the former programme of 2006 and focuses on updated knowledge on harbour porpoises, water birds and fish communities, and on the cumulative effects of wind farms. The scientific quality of the projects in this follow-up has been assessed by experts from the International Advisory Panel of Experts on Marine Ecology (IAPEME), who have commented on the results in an independent evaluation which is reproduced in this publication. (LN)

  2. Spontaneous obliteration of right ventricular pseudoaneurysm after blunt chest trauma: Diagnosis and follow-up with multidetector CT

    Energy Technology Data Exchange (ETDEWEB)

    Kang, Tae Kyung; Kang, Mi Jin; Kim, Jae Hyung [Sanggye Paik Hospital, Inje University College of Medicine, Seoul (Korea, Republic of)

    2014-06-15

    Right ventricular (RV) pseudoaneurysm caused by trauma is very rare. We report a case of RV pseudoaneurysm which resolved without surgical treatment in a patient who survived a falling accident. Echocardiography failed to identify the pseudoaneurysm. Electrocardiography-gated CT showed a 17-mm-sized saccular pseusoaneurysm arsing from the RV outflow tract with a narrow neck. Follow-up CT after two months showed spontaneous obliteration of the lesion.

  3. Advances in diagnosis and follow-up in kidney cancer

    NARCIS (Netherlands)

    Rioja, Jorge; de La Rosette, Jean J. M. C. H.; Wijkstra, Hessel; Laguna, M. Pilar

    2008-01-01

    PURPOSE OF REVIEW: To review the most recent data on preoperative diagnostic methods in kidney cancer and in follow-up and monitoring after ablation therapy. RECENT FINDINGS: Although the role of the percutaneous biopsy in the diagnostics of renal masses has been limited, new data suggest a high

  4. 38 CFR 41.315 - Audit findings follow-up.

    Science.gov (United States)

    2010-07-01

    ... include audit findings from multiple years, it shall include the fiscal year in which the finding... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Audit findings follow-up... (CONTINUED) AUDITS OF STATES, LOCAL GOVERNMENTS, AND NON-PROFIT ORGANIZATIONS Auditees § 41.315 Audit...

  5. Follow-up of conservatively treated sleep apnoea patients

    African Journals Online (AJOL)

    Health of School Children: Treatment of /ntestinal. Helminths and Schistosomiasis (WHO/GDS/IPI/GTD 92.1). Geneva: WHO, 1992. Accepted 17 June 1994. Follow-up of conservatively treated sleep apnoea patients. P. R. Bartel, J. Verster, P. J. Becker. Polysomnograms have been recorded at our laboratory since 1985 for ...

  6. Nimh Treatment Study of ADHD Follow-Up

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2004-04-01

    Full Text Available The effects of changes in medication use between 14 and 24 months follow-up on effectiveness (symptom ratings and growth (height and weight measures were analyzed, comparing 4 groups of patients, in the Multimodal Treatment Study of ADHD (MTA reported by the MTA Cooperative Group.

  7. Handbook of Exemplary Practices in Placement and Follow-Up.

    Science.gov (United States)

    Mehallis, Mantha Vlahos

    This handbook for teachers, counselors, and administrators presents exemplary practices in the use of job placement and follow-up services based on results of a survey of Florida school districts and community colleges. A description of survey methodology and the survey questionnaire, as well as a statewide profile of Florida exemplary practices…

  8. Factors Associated with Adherence to Follow-up Colposcopy

    Science.gov (United States)

    Fish, Laura J.; Moorman, Patricia G.; Wordlaw-Stintson, Lashawn; Vidal, Adriana; Smith, Jennifer S.; Hoyo, Cathrine

    2013-01-01

    Background: Understanding the gaps in knowledge about human papilloma virus (HPV) infection, transmission, and health consequences and factors associated with the knowledge gap is an essential first step for the development of interventions to improve adherence to follow-up among women with abnormal Pap smears. Purpose: To examine the relationship…

  9. Immunological follow-up of hydatid cyst cases

    Directory of Open Access Journals (Sweden)

    Bulut Vedat

    2001-01-01

    Full Text Available Hydatid disease is caused by Echinococcus granulosus. In this study, we aimed to investigate the benefit of monitoring cases with hydatid cyst by means of immune components in patients in a long-term follow-up after surgery. Eighty-four preoperative and postoperative serum samples from 14 cases undergoing surgery for hydatid disease were evaluated in terms of immune parameters, such as total and specific IgE, IgG, IgM, IgA and complement. Total and specific IgE were determined by ELISA. Specific IgG levels were measured by indirect hemaglutination.Total IgG, IgM, IgA and complement (C3 and C4 were detected by nephelometry. Imaging studies were also carried out during the follow-up. In none of the patients hydatid cysts were detected during the follow-up. Total IgE levels in the sera of the patients decreased to normal six months after surgery. Although specific IgE against echinococcal antigens decreased one year after operation, levels were still significantly high. There were no changes in the levels of anti-Echinococcus IgG and total IgG in follow-up period. Additionally, other parameters, such as IgA, IgM, C3 and C4, were not affected.

  10. Refractive surgery for accommodative esotropia: 5-year follow-up.

    Science.gov (United States)

    Magli, Adriano; Forte, Raimondo; Gallo, Flavio; Carelli, Roberta

    2014-02-01

    To assess the long-term effectiveness and safety of refractive surgery with LASIK or photorefractive keratectomy (PRK) for treating accommodative esotropia in adults. All patients with accommodative esotropia treated with LASIK or PRK until December 2007 and with a minimum follow-up of 5 years were retrospectively included. LASIK was performed on 44 eyes of 22 patients (12 women, 10 men; mean age: 22.7 ± 2.9 years). Mean postoperative follow-up was 62.1 ± 3.2 months. PRK was performed on 16 eyes of 8 patients (4 women, 4 men; mean age: 23.7 ± 1.7 years). Mean postoperative follow-up was 61.3 ± 2.8 months. At the 5-year follow-up, the mean cycloplegic refraction was more hyperopic in the PRK group (0.3 ± 0.8 vs 0.06 ± 0.3 diopters, P = .01). Correction of esotropia to esophoria or orthotropia was present in 21 patients (95.4%) treated with LASIK and in all patients treated with PRK. Both LASIK and PRK were effective in the long-term reduction of accommodative esotropia. Copyright 2014, SLACK Incorporated.

  11. Women's experiences of a follow up childbearing journey with ...

    African Journals Online (AJOL)

    The purpose of this study was to describe and analyse the lived experiences of the follow up journey of a pregnant woman by listening to the voices of women as they reflect on their journey. A qualitative, descriptive and contextual design was used to examine into each woman's experience of her world from pregnancy to ...

  12. [Follow-up and treatment outcome of early anorexia nervosa].

    Science.gov (United States)

    Schulze, U; Neudörfl, A; Krill, A; Warnke, A; Remschmidt, H; Herpertz-Dahlmann, B

    1997-03-01

    In a two-center follow-up study on the early-onset form of anorexia nervosa, we reexamined 43 (74%) of 58 former patients who had developed anorexia nervosa at the age of 13 years or younger. In addition to make a standardized assessment of the eating disorder at follow-up we assessed psychiatric comorbidity with a structured interview based on the criteria of DSM-III-R and ICD-10. After an average follow-up period of 6.8 years, 8 (18%) of our former patients had an eating disorder not otherwise specified (EDNOS) and 4 (9%) still suffered from anorexia nervosa. 5 (11%) of the subjects had developed bulimia nervosa. In 3 cases (7%) we found both syndromes. 12 (28%) of our former patients had an additional psychiatric disorder. The results of our study indicate that the quality of outcome in patients with an early-onset form of anorexia nervosa does not differ from that in individuals with a later manifestation of the eating disorder. Factors of prognostic relevance were the existence of an eating disorder during the first year of life and the duration of the follow-up period.

  13. Eight to ten years follow-up after carotid endarterectomy

    DEFF Research Database (Denmark)

    Knudsen Rathenborg, Lisbet; Sillesen, H; Schroeder, T

    1990-01-01

    Follow-up information was obtained on 185 patients who consecutively underwent carotid endarterectomy eight to ten years previously. Doppler ultrasound examination was performed in 59 patients who were still alive and living within 100 miles of the hospital. Using lifetable analysis, the annual r...

  14. Challenges of loss to follow-up in tuberculosis research

    DEFF Research Database (Denmark)

    Nissen, Thomas N; Rose, Michala V; Kimaro, Godfather

    2012-01-01

    In studies evaluating methods for diagnosing tuberculosis (TB), follow-up to verify the presence or absence of active TB is crucial and high dropout rates may significantly affect the validity of the results. In a study assessing the diagnostic performance of the QuantiFERON®-TB Gold In-Tube test...

  15. Nurse-Initiated Telephone Follow Up after Ureteroscopic Stone Surgery.

    Science.gov (United States)

    Tackitt, Helen M; Eaton, Samuel H; Lentz, Aaron C

    2016-01-01

    This article presents findings of a quality improvement (QI) project using the DMAIC (define, measure, analyze, improve, and control) model designed to decrease the rate of emergency department (ED) visits and nurse advice line calls after ureteroscopic stone surgery. Results indicated that nurse-initiated follow- up phone calls can decrease ED visits.

  16. A Follow-Up Study of the Deaf.

    Science.gov (United States)

    Reich, P. A.; Reich, C. M.

    Followed up through interviews and questionnaires were 278 former students, average age 28 years, of two residential schools and one day school for the deaf in Ontario. Data was collected on the degree of hearing loss, use of a hearing aid, educational and occupational history, social integration, methods of communication, and attitudes toward…

  17. Loss to Follow-Up: Issues and Recommendations

    Science.gov (United States)

    Hoffman, Jeff; Munoz, Karen F.; Bradham, Tamala S.; Nelson, Lauri

    2011-01-01

    State coordinators of early hearing detection and intervention (EHDI) programs completed a strengths, weaknesses, opportunities, and threats, or SWOT, analysis that examined 12 areas within state EHDI programs. Related to how EHDI programs address loss to follow-up, 47 coordinators responded with 277 items, and themes were identified in each…

  18. MRI of penile fracture: diagnosis and therapeutic follow-up

    International Nuclear Information System (INIS)

    Uder, Michael; Gohl, Dietrich; Takahashi, Masahide; Kramann, Bernhard; Schneider, Guenther

    2002-01-01

    A rupture of corpus cavernosum (CC) is a rare injury of the erect penis. The present study describes the role of MRI for diagnosis and follow-up of this injury. Four patients with clinically suspected acute penile fractures underwent MRI. Imaging findings were confirmed at surgery. In three patients, follow-up MRI was also available at 1, 6 and 16 weeks after surgical repair. In all patients pre-contrast T1-weighted images (T1WI) clearly disclosed ruptures of CC, which depicted as discontinuity of low signal intensity of the tunica albuginea (TA). Concomitant subcutaneous haematoma were well visualised both on T1-weighted (T1WI) and T2-weighted images, whereas haematoma in CC were optimally demonstrated on contrast-enhanced T1WI. On follow-up MRI all fractures presented similar healing process. Shortly after the repair, the tunical suture showed an increase in signal intensity on pre-contrast T1WI and was strongly enhanced with the administration of contrast material. Then the tear site gradually recovered low signal intensity on all spin-echo sequences by 4 months after surgery. These serial findings may suggest the formation of vascularised granulation tissue during cicatrisation. Magnetic resonance imaging is of great value for the diagnosis and follow-up in patients with penile fracture. (orig.)

  19. A formula for continued improvement: Audit follow-up

    International Nuclear Information System (INIS)

    Maday, J.H. Jr.

    1989-10-01

    In his book Management Audits, Allan J. Sayle states, ''QA standards stipulate that corrective action, required as a result of performing an audit, be followed up and closed out. There would, indeed, be little point in performing audits, requiring corrective action, or having a QA system at all if the auditee knows that the auditor will never verify that the corrective action has been efficaciously implemented.'' The QA auditor has an obligation to include follow-up in the overall audit planning. All too often the auditor will go to great lengths to plan and perform an audit only to have a recurring finding in the next audit. The proposed corrective action was only promissory and was not designed to stop the problem from recurring or to identify its root cause. Auditors do a disservice to the overall QA program and particularly to the customer when they fail to follow up and verify that an audit corrective action has been effectively implemented. In this paper, the techniques used by the quality assurance auditors at the Pacific Northwest Laboratory (PNL) will be presented. Although PNL is a research and development laboratory, the techniques outlined in this paper could be applied to any industry conducting quality assurance audits. Most important, they provide a formula for continued improvement by assuring that audit follow-up is timely, meaningful, and permanent

  20. Analytical framework and tool kit for SEA follow-up

    International Nuclear Information System (INIS)

    Nilsson, Mans; Wiklund, Hans; Finnveden, Goeran; Jonsson, Daniel K.; Lundberg, Kristina; Tyskeng, Sara; Wallgren, Oskar

    2009-01-01

    Most Strategic Environmental Assessment (SEA) research and applications have so far neglected the ex post stages of the process, also called SEA follow-up. Tool kits and methodological frameworks for engaging effectively with SEA follow-up have been conspicuously missing. In particular, little has so far been learned from the much more mature evaluation literature although many aspects are similar. This paper provides an analytical framework and tool kit for SEA follow-up. It is based on insights and tools developed within programme evaluation and environmental systems analysis. It is also grounded in empirical studies into real planning and programming practices at the regional level, but should have relevance for SEA processes at all levels. The purpose of the framework is to promote a learning-oriented and integrated use of SEA follow-up in strategic decision making. It helps to identify appropriate tools and their use in the process, and to systematise the use of available data and knowledge across the planning organization and process. It distinguishes three stages in follow-up: scoping, analysis and learning, identifies the key functions and demonstrates the informational linkages to the strategic decision-making process. The associated tool kit includes specific analytical and deliberative tools. Many of these are applicable also ex ante, but are then used in a predictive mode rather than on the basis of real data. The analytical element of the framework is organized on the basis of programme theory and 'DPSIR' tools. The paper discusses three issues in the application of the framework: understanding the integration of organizations and knowledge; understanding planners' questions and analytical requirements; and understanding interests, incentives and reluctance to evaluate

  1. The effect of increasing the dose of hydroxychloroquine (HCQ) in patients with refractory cutaneous lupus erythematosus (CLE): An open-label prospective pilot study.

    Science.gov (United States)

    Chasset, François; Arnaud, Laurent; Costedoat-Chalumeau, Nathalie; Zahr, Noel; Bessis, Didier; Francès, Camille

    2016-04-01

    Up to 30% of patients with cutaneous lupus erythematosus (CLE) fail to respond to hydroxychloroquine (HCQ). We sought to evaluate the efficacy of increased daily doses of HCQ on cutaneous response in refractory CLE. We conducted an open-label prospective study between 2010 and 2014. Patients with CLE and HCQ blood level less than or equal to 750 ng/mL were included. The daily dose of HCQ was increased to reach blood concentrations greater than 750 ng/mL. The primary end point was the number of responders defined by an improvement of CLE Disease Area and Severity Index score (4 points or 20% decrease) in patients with HCQ blood concentration greater than 750 ng/mL. We included 34 patients (26 women; median age 45 [range 28-72] years). Two nonadherent patients were excluded. The median CLE Disease Area and Severity Index score before treatment was significantly improved after treatment (8 [range 2-30] vs 1.5 [range 0-30]), P < .001). The primary response criterion was reached in 26 (81%) of the 32 patients analyzed. A decrease in HCQ doses without further CLE flare (median follow-up 15.8 [range 3.06-77.4] months) was achieved in 15 of the 26 responders. The main limitations of the study are its open-label design and the limited number of patients included. Increasing HCQ doses to reach blood concentrations greater than 750 ng/mL should be considered before addition of other treatments in refractory CLE. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  2. Follow-up of Antihypertensive Therapy Improves Blood Pressure Control: Results of HYT (HYperTension survey) Follow-up.

    Science.gov (United States)

    Fici, F; Seravalle, G; Koylan, N; Nalbantgil, I; Cagla, N; Korkut, Y; Quarti-Trevano, F; Makel, W; Grassi, G

    2017-09-01

    Although improved during the past few years, blood pressure control remains sub optimal. The impact of follow-up assessment on blood pressure control was evaluated in a group of patients of the HYT (HYperTension survey), treated with a combination of different dihydropyridine calcium-channel blockers (CCBs regimen) and inhibitors of renin-angiotensin-aldosterone system (RAAS) and with uncontrolled blood pressure. This was obtained assessing (a) the rate of blood pressure control at 3 and 6 months of follow-up in the whole group of patients, (b) the rate of blood pressure control and the average blood pressure values in subjects treated with different DHP-CCBs regimen. From the 4993 patients with uncontrolled blood pressure, (BP ≥ 140/90 or ≥140/85 in patients with diabetes), 3729 (mean age 61.2 ± 11.5 years), maintained CCBs regimen combined wih RAAS blockers and were evaluated at 3 and 6 months follow-up. At each visit BP (semiautomatic device, Omron-M6, 3 measurements), heart rate, adverse events and treatment persistence were collected. At 1st and 2nd follow-up the rate of controlled BP was 63.5 and 72.8% respectively (p blood pressure control; (b) there is no significant difference in the antihypertensive effect between different CCBs regimen; (c) lipophilic CCBs induce less ankle edema.

  3. CT follow-up of conservatively treated lumbar disc herniation

    International Nuclear Information System (INIS)

    Schumacher, M.; Fischer, R.; Thoden, U.

    1990-01-01

    A CT study was carried out on 43 patients with low back pain and sciatica who were treated conservatively. They were followed up for over 20 months (mean) clinically and monitored by CT before and after treatment. Initially, 38 of them had herniation and 5 had protrusion of the disc. At the time of follow-up only 24 of the initial 40 patients still had neurological deficits. In 76.7% of the patients CT showed an improvement (clear regression in 15 patients, moderate decrease in 18 patients). A favourable tendency towards regression was observed in disc herniation at the L5-S1 level and in cases showing sequestration. The prognosis was unfavourable in herniations at higher levels than L5-S1 and in lateral herniation reaching the intervertebral foramen. (orig.) [de

  4. [Laparoscopic management of ureteroileal stenosis: Long term follow up.

    Science.gov (United States)

    Emiliani, Esteban; Gavrilov, Pavel; Mayordomo, Olga; Salvador, Josep; Palou, Joan; Rosales, Antonio; Villavicencio, Humberto

    2017-05-01

    To describe the laparoscopic approach for uretero-ileal anastomosis strictures and to analyse our long term series. A retrospective review was performed evaluating our series of patients with benign ureteroileal anastomosis strictures treated laparoscopically from 2011 to 2017. Demographics and perioperative data were obtained and analyzed. Complications were described with the Clavien-Dindo classification. The surgical technique was described and a literature review was performed. Eleven procedures were performed in ten patients. Mean blood loss was 180 ml. All the operations were performed laparoscopically without conversion. Mean hospital stay was 10 days (4-23). Early complications were Clavien-Dindo I y II: Two cases of limited anastomosis leakage, one lymphorrea, one paralitic ileum and one accidental descent of the ureteral catheter. Mean follow-up was 56 months (12-179) No late complications have been described. Based on our series with 5 year follow up, the laparoscopic approach for uretero-ileal anastomosis strictures is feasible and safe.

  5. Role of cytology in screening, staging and follow-up

    International Nuclear Information System (INIS)

    Fischnaller, M.

    1986-01-01

    Cytology has become an integral component in the battery of diagnostic tools for a rational diagnosis of tumors. When all materials obtainable with sophisticated methods are utilized, almost every pulmonary lesion can be defined micromorphologically. In urgent cases instant staining techniques will permit a 'stat diagnosis'. The characterization of a tumor cell by cytology with accurate typing and grading offers preliminary information for subsequent staging efforts. Bronchial cancer may be both of the single-cell and of the mixed-cell type with the more aggressive cell elements determining the metastasising potential and prognosis. Sampling for cytology is devoid of risks and does not make any special demands on the patients; it can safely be repeated for follow-up studies; it helps to detect tumor regrowths or secondaries at an early stage during postoperative follow-up programs and to monitor treatment-related cellular changes. (Author)

  6. Treatment of craniopharyngioma estimated by follow-up CT

    Energy Technology Data Exchange (ETDEWEB)

    Kubota, T.; Ito, H.; Aizumi, S.; Yamamoto, S.; (Kanazawa Univ. (Japan). School of Medicine)

    1981-12-01

    Follow-up CT scans were taken from 12 cases of craniopharyngiomas after various treatment. Preoperative CT findings of craniopharyngiomas could be classified into three types. Type 1 was a non-enhanced or a thinly ring-like enhanced large cystic mass. Type 2 was a thickly enhanced large cystic mass with small solid mass. Type 3 was a large solid mass. Postoperative follow-up CT findings were as follows: Type 1 had a favorable postoperative course because the tumor tissues of the thin cystic wall seemed to collapse only with the procedure of cystic fluid aspiration. Recurrence frequently took place in patients of Type 2 and 3 if the tumor couldn't be radically removed or radiotherapy was not given after partial resection. Radiotherapy was most effective in these cases.

  7. Treatment of craniopharyngioma estimated by follow-up CT

    International Nuclear Information System (INIS)

    Kubota, Toshihiko; Ito, Haruhide; Aizumi, Shinichi; Yamamoto, Shinjiro

    1981-01-01

    Follow-up CT scans were taken from 12 cases of craniopharyngiomas after various treatment. Preoperative CT findings of craniopharyngiomas could be classified into three types. Type 1 was a non-enhanced or a thinly ring-like enhanced large cystic mass. Type 2 was a thickly enhanced large cystic mass with small solid mass. Type 3 was a large solid mass. Postoperative follow-up CT findings were as follows: Type 1 had a favorable postoperative course because the tumor tissues of the thin cystic wall seemed to collapse only with the procedure of cystic fluid aspiration. Recurrence frequently took place in patients of Type 2 and 3 if the tumor couldn't be radically removed or radiotherapy was not given after partial resection. Radiotherapy was most effective in these cases. (author)

  8. Electronic Whiteboards and Intensive Care Unit follow up

    DEFF Research Database (Denmark)

    Østergaard, Kija Lin; Brandrup, Morten

    -ended dry-erase whiteboard (make-up-your-own-sentences). In conclusion the primary feature in the two subjects is to optimize communication/collaboration and information between ICU and general wards in the transition. To make it a long term solution the content of such a support would need involvement...... of the end-users in the design process (Participatory Design). Hence these two findings, this review is setting the stage for further research on how electronic whiteboards can support the initial follow up when patients are transferred from an ICU to a general ward.......This paper is reviewing the existing literature on Intensive Care Unit (ICU) Outreach, in-hospital follow up 24 hours after the transition to a general ward from an ICU. It also touches upon the use of Electronic Whiteboards in a hospital setting and how the electronic whiteboards might support...

  9. [Follow-up of newborns with hypoxic-ischaemic encephalopathy].

    Science.gov (United States)

    Martínez-Biarge, M; Blanco, D; García-Alix, A; Salas, S

    2014-07-01

    Hypothermia treatment for newborn infants with hypoxic-ischemic encephalopathy reduces the number of neonates who die or have permanent neurological deficits. Although this therapy is now standard of care, neonatal hypoxic-ischaemic encephalopathy still has a significant impact on the child's neurodevelopment and quality of life. Infants with hypoxic-ischaemic encephalopathy should be enrolled in multidisciplinary follow-up programs in order to detect impairments, to initiate early intervention, and to provide counselling and support for families. This article describes the main neurodevelopmental outcomes after term neonatal hypoxic-ischaemic encephalopathy. We offer recommendations for follow-up based on the infant's clinical condition and other prognostic indicators, mainly neonatal neuroimaging. Other aspects, such as palliative care and medico-legal issues, are also briefly discussed. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  10. From themes to hypotheses: following up with quantitative methods.

    Science.gov (United States)

    Morgan, David L

    2015-06-01

    One important category of mixed-methods research designs consists of quantitative studies that follow up on qualitative research. In this case, the themes that serve as the results from the qualitative methods generate hypotheses for testing through the quantitative methods. That process requires operationalization to translate the concepts from the qualitative themes into quantitative variables. This article illustrates these procedures with examples that range from simple operationalization to the evaluation of complex models. It concludes with an argument for not only following up qualitative work with quantitative studies but also the reverse, and doing so by going beyond integrating methods within single projects to include broader mutual attention from qualitative and quantitative researchers who work in the same field. © The Author(s) 2015.

  11. [Normocalcemic primary hyperparathyroidism: recommendations for management and follow-up].

    Science.gov (United States)

    Martínez Díaz-Guerra, Guillermo; Jódar Gimeno, Esteban; Reyes García, Rebeca; Gómez Sáez, José Manuel; Muñoz-Torres, Manuel

    2013-10-01

    To provide practical recommendations for evaluation and follow-up of patients with normocalcemic primary hyperparathyroidism. Members of the Bone Metabolism Working Group of the Spanish Society of Endocrinology. A systematic search was made in MEDLINE (PubMed), using the terms normocalcemic primary hyperparathyroidism and primary hyperparathyroidism, for articles in English published before 22 November 2012. Literature was reviewed by 2 members of the Bone Metabolism Working Group of the Spanish Society of Endocrinology, and after development of recommendations, the manuscript was reviewed by all other members of the Group, and their suggestions were incorporated. The document provides practical recommendations for evaluation and follow-up of patients with normocalcemic primary hyperparathyroidism. There is however little evidence available about different aspects of this disease, mainly progression rate and clinical impact. More data are therefore needed before definite recommendations may be made. Copyright © 2012 SEEN. Published by Elsevier Espana. All rights reserved.

  12. Pneumatic dilatation in achalasia cardia results and follow-up.

    Directory of Open Access Journals (Sweden)

    Supe A

    1990-10-01

    Full Text Available Pneumatic dilatation is one of the more recent methods in the management of achalasia cardia. Fifty dilatations were done in 42 patients with achalasia cardia over 5 years. There was a significant decrease in the maximum diameter of the oesophagus and a significant increase in diameter in the narrowed lower oesophageal segment in all the patients. Of the patients studied, 95.23% were relieved of their symptoms after only one to two sessions. There were no immediate complications. Out of the 38 patients on long term follow up, 8 (21.05% had recurrence of symptoms. On repeat dilatations, 4 (50% of them had good response. Late complication like reflux oesophagitis was observed in only 1 patient over a median follow up period of 22 months. It was thus concluded that pneumatic dilatation is a safe, simple and effective procedure in managing patients with achalasia cardia.

  13. Hyperfunctioning thyroid cancer: a five-year follow-up.

    Science.gov (United States)

    Azevedo, Monalisa Ferreira; Casulari, Luiz Augusto

    2010-02-01

    Differentiated thyroid cancer rarely occurs in association with hyperfunctioning nodules. We describe a case of a 47-year-old woman who developed symptoms of hyperthyroidism associated with a palpable thyroid nodule. Thyroid scintigraphy showed an autonomous nodule, and fine-needle aspiration biopsy was suggestive of papillary carcinoma. Laboratorial findings were consistent with the diagnosis of hyperthyroidism. The patient underwent thyroidectomy and a papillary carcinoma of 3.0 x 3.0 x 2.0 cm, follicular variant, was described by histological examination. The surrounding thyroid tissue was normal. Postoperatively, the patient received 100 mCi of (131)I, and whole body scans detected only residual uptake. No evidence of metastasis was detected during five years of follow-up. Hot thyroid nodules rarely harbor malignancies, and this case illustrated that, when a carcinoma occurs the prognosis seems to be very good with no evidence of metastatic dissemination during a long-term follow-up.

  14. Radiological follow-up of uncemented knee prostheses. Preliminary study

    International Nuclear Information System (INIS)

    Martin Hervas, C.; Gomez Barrena, E.; Marquez Moreno, I.; Calle Yuste, F.; Ordonez Parra, J.M.

    1993-01-01

    The preliminary results of a prospective study of 40 uncemented total knee prostheses (TKP) are presented following a radiological protocol with fluoroscopic control and follow-up of over 2 years. The prosthesis-bone interface and the components alignment were assessed. Several radiological signs were studied to assess this interface with respect to the fixing of the component, but they showed little clinical correlation. Statistical significance (p<0.05, chisquare) was found only in the observation of sclerosis in areas of support for the tibital tray as a reaction of the bone. This radiological follow-up is of interest to determine the evolution of the interface and position of the implant to prevent complications (especially loosening) in patients, particularly those under 60 years old, who represent the group that can most benefit from prosthetic systems with uncemented anchorage because of their life expectation and level of activity. Author

  15. Feasibility of an EIS Follow-up Program

    International Nuclear Information System (INIS)

    Nelson, I.C.; Jaquish, R.E.; Watson, D.G.

    1982-12-01

    The proposed level of an EIS Follow-up Program is believed to be feasible and that it can and should be implemented. Guidance to authors should result in fewer, but more important, commitments for mitigating adverse environmental impacts. Selecting the significant commitments from Records of Decisions published since July 1, 1979 for tracking to satisfaction should result in conformance with regulations, orders, and the intent of the NEPA

  16. Follow-up of prenatally diagnosed unilateral hydronephrosis

    DEFF Research Database (Denmark)

    Thorup, Jørgen Mogens; Lenz, K; Rabol, A

    1996-01-01

    Based on previous experience with prenatally diagnosed unilateral hydronephrosis, we found that the primary indications for surgical intervention should be symptoms or functional impairment of the hydronephrotic kidney. Nonoperative management of neonates without symptoms and with normal function...... of the affected kidney was proposed. However, the strategy of treatment after prenatally diagnosed hydronephrosis is still controversial. We studied 28 consecutive children with suspected unilateral pelviureteral junction obstruction and a normal contralateral kidney. The overall follow-up period varied between 2...

  17. Ute Unit: Study Guide and Follow Up Activities.

    Science.gov (United States)

    North Conejos School District, Capulin, CO.

    The study guide and follow-up activities were designed primarily to give students a feeling of Ute life in the San Luis Valley in Colorado. The unit begins with six Southern Ute stories about the wolf and coyote, the race between the skunk and the coyote, the frog and the eagle, why the frog croaks, the bear (Que Ye Qat), and the two Indian…

  18. Radiographic follow-up study of Little Leaguer's shoulder

    International Nuclear Information System (INIS)

    Kanematsu, Yoshiji; Iwase, Takenobu; Matsuura, Tetsuya; Suzue, Naoto; Sairyo, Koichi; Kashiwaguchi, Shinji; Iwame, Toshiyuki

    2015-01-01

    Little Leaguer's shoulder is a syndrome involving the proximal humeral epiphyseal plate. Conservative treatment usually resolves the symptoms. However, there are no reports of a radiographic follow-up study of this disease. The purpose of this study was to show the radiographic healing process of Little Leaguer's shoulder. A total of 19 male baseball players diagnosed as having Little Leaguer's shoulder were retrospectively evaluated. The mean age at first presentation was 12.7 years. External rotation anteroposterior radiographs of the shoulder were taken. All patients were treated with rest from throwing, and no throwing was recommended until remodeling was confirmed. Follow-up radiographs were taken at 1-month intervals to assess healing. All patients were observed until healing was confirmed radiographically, after which they returned to baseball. The mean follow-up period was 8.5 months. In addition to radiography, patients were asked whether they had any symptoms and whether they had been able to return to baseball. At the first examination, radiographs showed a wider epiphyseal plate of the throwing side compared with the asymptomatic contralateral shoulder. Healing was observed in all cases. Healing occurred first along the medial side and was then extended laterally. The mean time required for healing was 4.7 months. All patients were able to return to playing baseball at their pre-injury level of play and were asymptomatic when examined at the final follow-up. The healing process of Little Leaguer's shoulder advanced from medial to lateral, and healing was achieved about 5 months after initial examination. (orig.)

  19. Follow-up of permanent hearing impairment in childhood.

    Science.gov (United States)

    Della Volpe, A; De Lucia, A; Pastore, V; Bracci Laudiero, L; Buonissimo, I; Ricci, G

    2016-02-01

    Programmes for early childhood childhood hearing impairment identification allows to quickly start the appropriate hearing aid fitting and rehabilitation process; nevertheless, a large number of patients do not join the treatment program. The goal of this article is to present the results of a strategic review of the strengths, weaknesses, opportunities and threats connected with the audiologic/prosthetic/language follow-up process of children with bilateral permanent hearing impairment. Involving small children, the follow-up includes the involvement of specialised professionals of a multidisciplinary team and a complex and prolonged multi-faced management. Within the framework of the Italian Ministry of Health project CCM 2013 "Preventing Communication Disorders: a Regional Program for Early Identification, Intervention and Care of Hearing Impaired Children", the purpose of this analysis was to propose recommendations that can harmonise criteria for outcome evaluation and provide guidance on the most appropriate assessment methods to be used in the follow-up course of children with permanent hearing impairment. © Copyright by Società Italiana di Otorinolaringologia e Chirurgia Cervico-Facciale.

  20. Neonatal follow-up program: Where do we stand?

    Science.gov (United States)

    2012-01-01

    Neonatal follow-up program (NFP) is becoming the corner stone of standard, high quality care provided to newborns at risk of future neuorodevelopmental delay. Most of the recognized neonatal intensive care units in the developed countries are adopting NFP as part of their mandatory care for the best long term outcome of high risk infants, especially very low birth weight (VLBW) infants. Unfortunately, in the developing and in underdeveloped countries, such early detection and intervention programs are rarely existing, mainly because of the lack of awareness of and exposure to such programs in spite of the increasing numbers of surviving sick newborns due to advancement in neonatal care in these countries. This is a review article to explore the Neonatal follow-up programs looking at historical development, benefts and aims, and standard requirements for successful program development that can be adopted in our countries. In conclusion, proper Neonatal follow-up programs are needed to improve neonatal outcome. Therefore all professionals working in the feld of neonatal care in developing countries should cooperate to create such programs for early detection and hence early intervention for any adverse long term outcome in high-risk newborn infants PMID:27493326

  1. Complications and Follow-up after Unprotected Carotid Artery Stenting

    International Nuclear Information System (INIS)

    Hauth, Elke A.M.; Drescher, Robert; Jansen, Christian; Gissler, H. Martin; Schwarz, Michael; Forsting, Michael; Jaeger, Horst J.; Mathias, Klaus D.

    2006-01-01

    Purpose. This prospective study was undertaken to determine the success rate, complications, and outcome of carotid artery stenting (CAS) without the use of cerebral protection devices. Methods. During 12 months, 94 high-grade stenoses of the carotid artery in 91 consecutive patients were treated. Sixty-six (70%) of the stenoses were symptomatic and 28 (30%) were asymptomatic. Results. In all 94 carotid stenoses CAS was successfully performed. During the procedure and within the 30 days afterwards, there were 2 deaths and 3 major strokes in the 66 symptomatic patients, resulting in a combined death and stroke rate of 5 of 66 (7%). Only one of these complications, a major stroke, occurred during the procedure. In the 6-month follow-up, one additional major stroke occurred in a originally symptomatic patient resulting in a combined death and stroke rate of 6 of 66 (10%) for symptomatic patients at 6 months. No major complications occurred in asymptomatic patients during the procedure or in the 6-month follow-up period. At 6 months angiographic follow-up the restenosis rate with a degree of >50% was 3 of 49 (6%) and the rate with a degree of ≥70% was 1 of 49 (2%). Conclusions. Cerebral embolization during CAS is not the only cause of the stroke and death rate associated with the procedure. The use of cerebral protection devices during the procedure may therefore not prevent all major complications following CAS

  2. Mortality in acromegaly: a 20-year follow-up study.

    Science.gov (United States)

    Ritvonen, Elina; Löyttyniemi, Eliisa; Jaatinen, Pia; Ebeling, Tapani; Moilanen, Leena; Nuutila, Pirjo; Kauppinen-Mäkelin, Ritva; Schalin-Jäntti, Camilla

    2016-06-01

    It is unclear whether mortality still is increased in acromegaly and whether there are gender-related differences. We dynamically assessed outcome during long-term follow-up in our nationwide cohort. We studied standardized mortality ratios (SMRs) relative to the general population and causes of death in acromegaly (n=333) compared with age- and gender-matched controls (n=4995). During 20 (0-33) years follow-up, 113 (34%) patients (n=333, 52% women) and 1334 (27%) controls (n=4995) died (P=0.004). SMR (1.9, 95% CI: 1.53-2.34, Pacromegaly. Overall distribution of causes of death (Pacromegaly, but not in controls, causes of deaths shifted from 44% cardiovascular and 28% cancer deaths during the first decade, to 23% cardiovascular and 35% cancer deaths during the next two decades. In acromegaly, cancer deaths were mostly attributed to pancreatic adenocarcinoma (n=5), breast (n=4), lung (n=3) and colon (n=3) carcinoma. In acromegaly, men were younger than women at diagnosis (median 44.5 vs 50 years, Pacromegaly, men are younger at diagnosis and death than women. Compared with controls, mortality is increased during 20 years of follow-up, especially in women. Causes of deaths shift from predominantly cardiovascular to cancer deaths. © 2016 Society for Endocrinology.

  3. [Guidelines for the follow up of patients with bronchopulmonary dysplasia].

    Science.gov (United States)

    Pérez Tarazona, S; Rueda Esteban, S; Alfonso Diego, J; Barrio Gómez de Agüero, M I; Callejón Callejón, A; Cortell Aznar, I; de la Serna Blázquez, O; Domingo Miró, X; García García, M L; García Hernández, G; Luna Paredes, C; Mesa Medina, O; Moreno Galdó, A; Moreno Requena, L; Pérez Pérez, G; Salcedo Posadas, A; Sánchez Solís de Querol, M; Torrent Vernetta, A; Valdesoiro Navarrete, L; Vilella Sabaté, M

    2016-01-01

    Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth, and remains a major problem in pediatric pulmonology units. The decision of discharging from the Neonatal Unit should be based on a thorough assessment of the condition of the patient and compliance with certain requirements, including respiratory and nutritional stability, and caregiver education on disease management. For proper control of the disease, a schedule of visits and complementary tests should be established prior to discharge, and guidelines for prevention of exacerbations and appropriate treatment should be applied. In this paper, the Working Group in Perinatal Respiratory Diseases of the Spanish Society of Pediatric Pulmonology proposes a protocol to serve as a reference for the follow up of patients with BPD among different centers and health care settings. Key factors to consider when planning discharge from the Neonatal Unit and during follow up are reviewed. Recommendations on treatment and prevention of complications are then discussed. The final section of this guide aims to provide a specific schedule for follow-up and diagnostic interventions to be performed in patients with BPD. Copyright © 2015 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

  4. Follow-Up Photometry of Kelt Transiting Planet Candidates

    Science.gov (United States)

    Stephens, Denise C.; Joner, Michael D.; Hintz, Eric G.; Martin, Trevor; Spencer, Alex; Kelt Follow-Up Network (FUN) Team

    2017-10-01

    We have three telescopes at BYU that we use to follow-up possible transiting planet canidates for the KELT team. These telescopes were used to collect data on Kelt-16b and Kelt-9b, which is the hottest known exoplanet. More recently we used the newest of these telescopes, a robotic 8-inch telescope on the roof of our building, to confirm the most recent Kelt planet that will be published soon. This research has been ideal for the teaching and training of undergraduate students in the art of photometric observing and data reduction. In this presentation I will highlight how we are using our membership in the Kelt team to further the educational objective of our undergraduate astronomy program, while contributing meaningful science to the ever growing field of exoplanet discovery. I will also highlight a few of the more interesting Kelt planets and the minimum telescope requirements for detecting these planets. I will then discuss the sensitivities required to follow-up future TESS candidates, which may be of interest to others interested in joining the TESS follow-up teams.

  5. Appraising the value of independent EIA follow-up verifiers

    Energy Technology Data Exchange (ETDEWEB)

    Wessels, Jan-Albert, E-mail: janalbert.wessels@nwu.ac.za [School of Geo and Spatial Sciences, Department of Geography and Environmental Management, North-West University, C/O Hoffman and Borcherd Street, Potchefstroom, 2520 (South Africa); Retief, Francois, E-mail: francois.retief@nwu.ac.za [School of Geo and Spatial Sciences, Department of Geography and Environmental Management, North-West University, C/O Hoffman and Borcherd Street, Potchefstroom, 2520 (South Africa); Morrison-Saunders, Angus, E-mail: A.Morrison-Saunders@murdoch.edu.au [School of Geo and Spatial Sciences, Department of Geography and Environmental Management, North-West University, C/O Hoffman and Borcherd Street, Potchefstroom, 2520 (South Africa); Environmental Assessment, School of Environmental Science, Murdoch University, Australia. (Australia)

    2015-01-15

    Independent Environmental Impact Assessment (EIA) follow-up verifiers such as monitoring agencies, checkers, supervisors and control officers are active on various construction sites across the world. There are, however, differing views on the value that these verifiers add and very limited learning in EIA has been drawn from independent verifiers. This paper aims to appraise how and to what extent independent EIA follow-up verifiers add value in major construction projects in the developing country context of South Africa. A framework for appraising the role of independent verifiers was established and four South African case studies were examined through a mixture of site visits, project document analysis, and interviews. Appraisal results were documented in the performance areas of: planning, doing, checking, acting, public participating and integration with other programs. The results indicate that independent verifiers add most value to major construction projects when involved with screening EIA requirements of new projects, allocation of financial and human resources, checking legal compliance, influencing implementation, reporting conformance results, community and stakeholder engagement, integration with self-responsibility programs such as environmental management systems (EMS), and controlling records. It was apparent that verifiers could be more creatively utilized in pre-construction preparation, providing feedback of knowledge into assessment of new projects, giving input to the planning and design phase of projects, and performance evaluation. The study confirms the benefits of proponent and regulator follow-up, specifically in having independent verifiers that disclose information, facilitate discussion among stakeholders, are adaptable and proactive, aid in the integration of EIA with other programs, and instill trust in EIA enforcement by conformance evaluation. Overall, the study provides insight on how to harness the learning opportunities

  6. Appraising the value of independent EIA follow-up verifiers

    International Nuclear Information System (INIS)

    Wessels, Jan-Albert; Retief, Francois; Morrison-Saunders, Angus

    2015-01-01

    Independent Environmental Impact Assessment (EIA) follow-up verifiers such as monitoring agencies, checkers, supervisors and control officers are active on various construction sites across the world. There are, however, differing views on the value that these verifiers add and very limited learning in EIA has been drawn from independent verifiers. This paper aims to appraise how and to what extent independent EIA follow-up verifiers add value in major construction projects in the developing country context of South Africa. A framework for appraising the role of independent verifiers was established and four South African case studies were examined through a mixture of site visits, project document analysis, and interviews. Appraisal results were documented in the performance areas of: planning, doing, checking, acting, public participating and integration with other programs. The results indicate that independent verifiers add most value to major construction projects when involved with screening EIA requirements of new projects, allocation of financial and human resources, checking legal compliance, influencing implementation, reporting conformance results, community and stakeholder engagement, integration with self-responsibility programs such as environmental management systems (EMS), and controlling records. It was apparent that verifiers could be more creatively utilized in pre-construction preparation, providing feedback of knowledge into assessment of new projects, giving input to the planning and design phase of projects, and performance evaluation. The study confirms the benefits of proponent and regulator follow-up, specifically in having independent verifiers that disclose information, facilitate discussion among stakeholders, are adaptable and proactive, aid in the integration of EIA with other programs, and instill trust in EIA enforcement by conformance evaluation. Overall, the study provides insight on how to harness the learning opportunities

  7. Progressive numbness of distal limbs for two years, unsteady gait for two months

    Directory of Open Access Journals (Sweden)

    Jun MA

    2016-11-01

    Full Text Available A 50-year-old female was admitted to our department, complaining of progressive numbness of distal limbs for two years and unsteady gait for two months. “Peripheral neuropathy” was the presumed diagnosis. She has suffered dry mouth for months. Neurological examination revealed proximal upper muscle strength was normal and distal was 5-/5 while muscle strength in lower limbs was normal. Tendon reflexes in all limbs were reduced, and superficial sensation as well as deep sensation in all limbs was also diminished. Deep sensation below T8-10 was diminished. Romberg’s test was positive with negative pathological reflex. Several sensory nerves action potentials (SNAPs were diminished or absent with normal compound muscle action potentials (CMAPs. Cervical MRI showed hyperintensities in the dorsal column. Serum anti-Ro/SSA antibody was positive. Tear break-up time was abnormal in either eye (5s, normal range>10s; the rate of saliva production declined 0.02 ml/min (> 1.50 ml/15 min; parotid gland contrast sialography was abnormal; lip biopsy was positive with focal lymphocytic sialadenitis with focus score ≥1. The patient was diagnosed as primary Sjogren's syndrome and sensory neuronopathy. She received oral prednisone in dose of 1mg/(kg·d for four weeks, then reduce the dosage with 5mg/w to 0.50mg/ (kg·d. Later she reduced the dosage with 2.5mg/per week. At the same time, she got cyclophosphamide (100mg every other day and hydroxychloroquine (0.20g twice a day. Numbness of limbs and unsteady gait were improved when the patient was discharged. Two month later, during the follow-up, the patient’ gait was slightly improved, but the numbness still existed. DOI: 10.3969/j.issn.1672-6731.2016.11.016

  8. Colorectal cancer (CRC) monitoring by 6-monthly 18FDG-PET/CT: an open-label multicentre randomised trial.

    Science.gov (United States)

    Sobhani, I; Itti, E; Luciani, A; Baumgaertner, I; Layese, R; André, T; Ducreux, M; Gornet, J-M; Goujon, G; Aparicio, T; Taieb, J; Bachet, J-B; Hemery, F; Retbi, A; Mons, M; Flicoteaux, R; Rhein, B; Baron, S; Cherrak, I; Rufat, P; Le Corvoisier, P; de'Angelis, N; Natella, P-A; Maoulida, H; Tournigand, C; Durand Zaleski, I; Bastuji-Garin, S

    2018-04-01

    [18F]2-fluoro-2-deoxy-d-glucose positron emission tomography/computed tomography (18FDG-PET/CT) has high sensitivity for detecting recurrences of colorectal cancer (CRC). Our objective was to determine whether adding routine 6-monthly 18FDG-PET/CT to our usual monitoring strategy improved patient outcomes and to assess the effect on costs. In this open-label multicentre trial, patients in remission of CRC (stage II perforated, stage III, or stage IV) after curative surgery were randomly assigned (1 : 1) to usual monitoring alone (3-monthly physical and tumour marker assays, 6-monthly liver ultrasound and chest radiograph, and 6-monthly whole-body computed tomography) or with 6-monthly 18FDG-PET/CT, for 3 years. A multidisciplinary committee reviewed each patient's data every 3 months and classified the recurrence status as yes/no/doubtful. Recurrences were treated with curative surgery alone if feasible and with chemotherapy otherwise. The primary end point was treatment failure defined as unresectable recurrence or death. Relative risks were estimated, and survival was analysed using the Kaplan-Meier method, log-rank test, and Cox models. Direct costs were compared. Of the 239 enrolled patients, 120 were in the intervention arm and 119 in the control arm. The failure rate was 29.2% (31 unresectable recurrences and 4 deaths) in the intervention group and 23.7% (27 unresectable recurrences and 1 death) in the control group (relative risk = 1.23; 95% confidence interval, 0.80-1.88; P = 0.34). The multivariate analysis also showed no significant difference (hazards ratio, 1.33; 95% confidence interval, 0.8-2.19; P = 0.27). Median time to diagnosis of unresectable recurrence (months) was significantly shorter in the intervention group [7 (3-20) versus 14.3 (7.3-27), P = 0.016]. Mean cost/patient was higher in the intervention group (18 192 ± 27 679 € versus 11 131 ± 13  €, P CRC. The control group had very close follow-up

  9. Holter-electrocardiogram-monitoring in patients with acute ischaemic stroke (Find-AFRANDOMISED): an open-label randomised controlled trial.

    Science.gov (United States)

    Wachter, Rolf; Gröschel, Klaus; Gelbrich, Götz; Hamann, Gerhard F; Kermer, Pawel; Liman, Jan; Seegers, Joachim; Wasser, Katrin; Schulte, Anna; Jürries, Falko; Messerschmid, Anna; Behnke, Nico; Gröschel, Sonja; Uphaus, Timo; Grings, Anne; Ibis, Tugba; Klimpe, Sven; Wagner-Heck, Michaela; Arnold, Magdalena; Protsenko, Evgeny; Heuschmann, Peter U; Conen, David; Weber-Krüger, Mark

    2017-04-01

    Atrial fibrillation is a major risk factor for recurrent ischaemic stroke, but often remains undiagnosed in patients who have had an acute ischaemic stroke. Enhanced and prolonged Holter-electrocardiogram-monitoring might increase detection of atrial fibrillation. We therefore investigated whether enhanced and prolonged rhythm monitoring was better for detection of atrial fibrillation than standard care procedures in patients with acute ischaemic stroke. Find-AF randomised is an open-label randomised study done at four centres in Germany. We recruited patients with acute ischaemic stroke (symptoms for 7 days or less) aged 60 years or older presenting with sinus rhythm and without history of atrial fibrillation. Patients were included irrespective of the suspected cause of stroke, unless they had a severe ipsilateral carotid or intracranial artery stenosis, which were the exclusion criteria. We used a computer-generated allocation sequence to randomly assign patients in a 1:1 ratio with permuted block sizes of 2, 4, 6, and 8, stratified by centre, to enhanced and prolonged monitoring (ie, 10-day Holter-electrocardiogram [ECG]-monitoring at baseline, and at 3 months and 6 months of follow-up) or standard care procedures (ie, at least 24 h of rhythm monitoring). Participants and study physicians were not masked to group assignment, but the expert committees that adjudicated endpoints were. The primary endpoint was the occurrence of atrial fibrillation or atrial flutter (30 sec or longer) within 6 months after randomisation and before stroke recurrence. Because Holter ECG is a widely used procedure and not known to harm patients, we chose not to assess safety in detail. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01855035. Between May 8, 2013, and Aug 31, 2014, we recruited 398 patients. 200 patients were randomly assigned to the enhanced and prolonged monitoring group and 198 to the standard care group. After 6

  10. An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis.

    Science.gov (United States)

    Dolling, David I; Desai, Monica; McOwan, Alan; Gilson, Richard; Clarke, Amanda; Fisher, Martin; Schembri, Gabriel; Sullivan, Ann K; Mackie, Nicola; Reeves, Iain; Portman, Mags; Saunders, John; Fox, Julie; Bayley, Jake; Brady, Michael; Bowman, Christine; Lacey, Charles J; Taylor, Stephen; White, David; Antonucci, Simone; Gafos, Mitzy; McCormack, Sheena; Gill, Owen N; Dunn, David T; Nardone, Anthony

    2016-03-24

    Pre-exposure prophylaxis (PrEP) has proven biological efficacy to reduce the sexual acquisition of the human immunodeficiency virus (HIV). The PROUD study found that PrEP conferred higher protection than in placebo-controlled trials, reducing HIV incidence by 86 % in a population with seven-fold higher HIV incidence than expected. We present the baseline characteristics of the PROUD study population and place the findings in the context of national sexual health clinic data. The PROUD study was designed to explore the real-world effectiveness of PrEP (tenofovir-emtricitabine) by randomising HIV-negative gay and other men who have sex with men (GMSM) to receive open-label PrEP immediately or after a deferral period of 12 months. At enrolment, participants self-completed two baseline questionnaires collecting information on demographics, sexual behaviour and lifestyle in the last 30 and 90 days. These data were compared to data from HIV-negative GMSM attending sexual health clinics in 2013, collated by Public Health England using the genitourinary medicine clinic activity database (GUMCAD). The median age of participants was 35 (IQR: 29-43). Typically participants were white (81 %), educated at a university level (61 %) and in full-time employment (72 %). Of all participants, 217 (40 %) were born outside the UK. A sexually transmitted infection (STI) was reported to have been diagnosed in the previous 12 months in 330/515 (64 %) and 473/544 (87 %) participants reported ever having being diagnosed with an STI. At enrolment, 47/280 (17 %) participants were diagnosed with an STI. Participants reported a median (IQR) of 10 (5-20) partners in the last 90 days, a median (IQR) of 2 (1-5) were condomless sex acts where the participant was receptive and 2 (1-6) were condomless where the participant was insertive. Post-exposure prophylaxis had been prescribed to 184 (34 %) participants in the past 12 months. The number of STI diagnoses was high compared to those reported in

  11. A Remote Collaborative Care Program for Patients with Depression Living in Rural Areas: Open-Label Trial.

    Science.gov (United States)

    Rojas, Graciela; Guajardo, Viviana; Martínez, Pablo; Castro, Ariel; Fritsch, Rosemarie; Moessner, Markus; Bauer, Stephanie

    2018-04-30

    In the treatment of depression, primary care teams have an essential role, but they are most effective when inserted into a collaborative care model for disease management. In rural areas, the shortage of specialized mental health resources may hamper management of depressed patients. The aim was to test the feasibility, acceptability, and effectiveness of a remote collaborative care program for patients with depression living in rural areas. In a nonrandomized, open-label (blinded outcome assessor), two-arm clinical trial, physicians from 15 rural community hospitals recruited 250 patients aged 18 to 70 years with a major depressive episode (DSM-IV criteria). Patients were assigned to the remote collaborative care program (n=111) or to usual care (n=139). The remote collaborative care program used Web-based shared clinical records between rural primary care teams and a specialized/centralized mental health team, telephone monitoring of patients, and remote supervision by psychiatrists through the Web-based shared clinical records and/or telephone. Depressive symptoms, health-related quality of life, service use, and patient satisfaction were measured 3 and 6 months after baseline assessment. Six-month follow-up assessments were completed by 84.4% (221/250) of patients. The remote collaborative care program achieved higher user satisfaction (odds ratio [OR] 1.94, 95% CI 1.25-3.00) and better treatment adherence rates (OR 1.81, 95% CI 1.02-3.19) at 6 months compared to usual care. There were no statically significant differences in depressive symptoms between the remote collaborative care program and usual care. Significant differences between groups in favor of remote collaborative care program were observed at 3 months for mental health-related quality of life (beta 3.11, 95% CI 0.19-6.02). Higher rates of treatment adherence in the remote collaborative care program suggest that technology-assisted interventions may help rural primary care teams in the management

  12. Can JWST Follow Up on Gravitational-Wave Detections?

    Science.gov (United States)

    Kohler, Susanna

    2016-02-01

    Bitten by the gravitational-wave bug? While we await Thursdays press conference, heres some food for thought: if LIGO were able to detect gravitational waves from compact-object mergers, how could we follow up on the detections? A new study investigates whether the upcoming James Webb Space Telescope (JWST) will be able to observe electromagnetic signatures of some compact-object mergers.Hunting for MergersStudying compact-object mergers (mergers of black holes and neutron stars) can help us understand a wealth of subjects, like high-energy physics, how matter behaves at nuclear densities, how stars evolve, and how heavy elements in the universe were created.The Laser Interferometer Gravitational-Wave Observatory (LIGO) is searching for the signature ripples in spacetime identifying these mergers, but gravitational waves are squirrelly: LIGO will only be able to localize wave sources to tens of square degrees. If we want to find out more about any mergers LIGO discovers in gravitational waves, well need a follow-up search for electromagnetic counterparts with other observatories.The Kilonova KeyOne possible electromagnetic counterpart is kilonovae, explosions that can be produced during a merger of a binary neutron star or a neutron starblack hole system. If the neutron star is disrupted during the merger, some of the hot mass is flung outward and shines brightly by radioactive decay.Kilonovae are especially promising as electromagnetic counterparts to gravitational waves for three reasons:They emit isotropically, so the number of observable mergers isnt limited by relativistic beaming.They shine for a week, giving follow-up observatories time to search for them.The source location can beeasily recovered.The only problem? We dont currently have any sensitive survey instruments in the near-infrared band (where kilonova emission peaks) that can provide coverage over tens of square degrees. Luckily, we will soon have just the thing: JWST, launching in 2018!JWSTs

  13. Sleep During Menopausal Transition: A 6-Year Follow-Up.

    Science.gov (United States)

    Lampio, Laura; Polo-Kantola, Päivi; Himanen, Sari-Leena; Kurki, Samu; Huupponen, Eero; Engblom, Janne; Heinonen, Olli J; Polo, Olli; Saaresranta, Tarja

    2017-07-01

    Menopausal transition is associated with increased dissatisfaction with sleep, but the effects on sleep architecture are conflicting. This prospective 6-year follow-up study was designed to evaluate the changes in sleep stages and sleep continuity that occur in women during menopausal transition. Sixty women (mean age 46.0 years, SD 0.9) participated. All women were premenopausal at baseline, and at the 6-year follow-up, women were in different stages of menopausal transition. Polysomnography was used to study sleep architecture at baseline and follow-up. The effects of aging and menopause (assessed as change in serum follicle-stimulating hormone [S-FSH]) on sleep architecture were evaluated using linear regression models. After controlling for body mass index, vasomotor, and depressive symptoms, aging of 6 years resulted in shorter total sleep time (B -37.4, 95% confidence interval [CI] -71.5 to (-3.3)), lower sleep efficiency (B -6.5, 95%CI -12.7 to (-0.2)), as well as in increased transitions from slow-wave sleep (SWS) to wakefulness (B 1.0, 95%CI 0.1 to 1.9), wake after sleep onset (B 37.7, 95%CI 12.5 to 63.0), awakenings per hour (B 1.8, 95%CI 0.8 to 2.8), and arousal index (B 2.3, 95%CI 0.1 to 4.4). Higher S-FSH concentration in menopausal transition was associated with increased SWS (B 0.09, 95%CI 0.01 to 0.16) after controlling for confounding factors. A significant deterioration in sleep continuity occurs when women age from 46 to 52 years, but change from premenopausal to menopausal state restores some SWS. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  14. Neuroradiolological diagnosis and follow-up of brain tumors

    International Nuclear Information System (INIS)

    Kummer, R. von

    1997-01-01

    Primary tumors of the brain and cerebral metastases cause considerable morbidity and mortality. To assess the chance for cure and to develop a valid concept of treatment, the exact assessment of the tumor's location, of the tumor's borders and malignancy is essential. Today, neuroradiological examination mainly with magnetic resonance imaging (MRI) allows an almost histological diagnosis and description of the tumor's extent. MRI is as well useful for studying the patient's short- and long-term follow-up clinical course. This is illustrated by 3 case histories. (orig.)

  15. Primary cemented total hip arthroplasty: 10 years follow-up

    Directory of Open Access Journals (Sweden)

    Nath Rajendra

    2010-01-01

    Full Text Available Background: Primary cemented total hip arthroplasty is a procedure for non-traumatic and traumatic affections of the hip. Long term follow-up is required to assess the longevity of the implant and establish the procedure. Indo-Asian literature on long term result of total hip arthroplasty is sparse. We present a 10-year follow-up of our patients of primary cemented total hip arthroplasty. Materials and Methods: We operated 31 hips in 30 patients with primary cemented total hip arthroplasty. We followed the cases for a minimum period of 10 years with a mean follow-up period of 12.7 years. The mean age of the patients was 60.7 years (range 37-82 yrs male to female ratio was 2:1. The clinical diagnoses included - avascular necrosis of femoral head (n=15, sero positive rheumatoid arthritis (n=5, seronegative spondylo-arthropathy (n=4, neglected femoral neck fractures (n=3, healed tubercular arthritis (n=2 and post traumatic osteoarthritis of hip (n=2. The prostheses used were cemented Charnley′s total hip (n=12 and cemented modular prosthesis (n=19. The results were assessed according to Harris hip score and radiographs taken at yearly intervals. Results: The mean follow-up is 12.7 yrs (range 11-16 yrs Results in all operated patients showed marked improvement in Harris hip score from preoperative mean 29.2 to 79.9 at 10 years or more followup. However, the non-inflammatory group showed more sustained long term improvement as compared to the inflammatory group, as revealed by the Harris hip score. Mean blood loss was 450ml (±3.7 ml, mean transfusion rate was 1.2 units (±.3. The complications were hypotension (n=7, shortening> 1.5 cm (n=9, superficial infection (n=2 and malposition of prosthesis (n=1. Conclusion: The needs of Indian Asian patients, vary from what is discussed in literature. The pain tolerance is greater than western population and financial constraints are high. Thus revision surgery among Indian-Asian patients is less compared

  16. GRBs optical follow-up observation at Lunin observatory, Taiwan

    Energy Technology Data Exchange (ETDEWEB)

    Huang, K.Y.; Ip, W.H. [Chung-Li Univ., Taiwan (China). Institute of astronomy; Urata, Y. [RIKEN, Saitama (Japan); Tokyo Institute of Technology, Tokyo (Japan). Department of Physics; Tamagawa, T.; Onda, K. [RIKEN, Saitama (Japan); Makishima, K. [RIKEN, Saitama (Japan); Tokyo Univ., Tokyo (Japan). Department of Physics

    2005-07-15

    The Lulin GRB program, using the Lulin One-meter Telescope (LOT) in Taiwan started in July 2003. Its scientific aims are to discover optical counterparts of XRFs and short and long GRBs, then to quickly observe them in multiple bands. Thirteen follow-up observations were provided by LOT between July 2003 and Feb. 2005. One host galaxy was found at GRB 031203. Two optical afterglows were detected for GRB 040924 and GRB 041006. In addition, the optical observations of GRB 031203 and a discussion of the non-detection of the optical afterglow of GRB 031203 are also reported in this article.

  17. GRBs optical follow-up observation at Lunin observatory, Taiwan

    International Nuclear Information System (INIS)

    Huang, K.Y.; Ip, W.H.; Makishima, K.; Tokyo Univ., Tokyo

    2005-01-01

    The Lulin GRB program, using the Lulin One-meter Telescope (LOT) in Taiwan started in July 2003. Its scientific aims are to discover optical counterparts of XRFs and short and long GRBs, then to quickly observe them in multiple bands. Thirteen follow-up observations were provided by LOT between July 2003 and Feb. 2005. One host galaxy was found at GRB 031203. Two optical afterglows were detected for GRB 040924 and GRB 041006. In addition, the optical observations of GRB 031203 and a discussion of the non-detection of the optical afterglow of GRB 031203 are also reported in this article

  18. Postoperative follow-up studies in biliary atresia using radioisotope

    Energy Technology Data Exchange (ETDEWEB)

    Kanto, Kei; Ishida, Haruo; Hayashi, Akira; Kamagata, Shoichiro; Sanbonmatsu, Toru; Matsufuji, Hiroshi; Ishii, Katsumi

    1988-09-01

    With increasing numbers of long survival patients in biliary atresia, associated diseases such as liver cirrhosis and portal hypertension seem to be more important in their course. We use liver scintigraphy, hepatobiliary scintigraphy and transrectal portal scintigraphy as the follow-up study. Three studies generally correlate the present state of the patients, but there seems to be dissociation in the group of cirrhosis without icterus which are encountered most often in biliary atresia. That can be seen in hepatobiliary scintigraphy especially. So we emphasis that to choose several isotope studies are essential in determination of the postoperative state in biliary atresia.

  19. Follow-up study of memory deficits after ECT.

    Science.gov (United States)

    Shellenberger, W; Miller, M J; Small, I F; Milstein, V; Stout, J R

    1982-06-01

    Twenty-four patients received ECT induced by either alternating sine wave or brief pulsed-square wave stimulus and were evaluated at follow-up for clinical functioning and subjective memory loss. The hypothesis of less memory loss in the group receiving a weaker stimulus (pulsed-square wave) was not supported. The two treatment groups and a group of controls showed no significant differences on the memory test. On measures of clinical functioning the sine wave group scored better on every measure than the square wave group, although not significantly better.

  20. A follow-up of transients. Stage 1

    International Nuclear Information System (INIS)

    Enekull, Aa.; Wallner, B.

    1981-09-01

    A follow-up of the transients of temperature and pressure in the primary pressurized system of a nuclear power plant has been completed for the Barsebaeck-1 reactor. The investigation consists of the following steps:- the collation of transients - drawing up load data based on transients-analyses of stress - recommendations for future programs. It was found that the lifetime of the system will exceed 40 years excluding some of the pipes for feed water. The appendices give a detailed description of the transients.(G.B.)

  1. Shillapoo Wildlife Area 2007 Follow-up HEP Report.

    Energy Technology Data Exchange (ETDEWEB)

    Ashley, Paul R.

    2008-03-01

    In April and May 2007 the Regional HEP Team (RHT) conducted a follow-up HEP analysis on the Egger (612 acres) and Herzog (210 acres) parcels located at the north end of the Shillapoo Wildlife Area. The Egger and Herzog parcels have been managed with Bonneville Power Administration funds since acquired in 1998 and 2001 respectively. Slightly more than 936 habitat units (936.47) or 1.14 HUs per acre was generated as an outcome of the 2007 follow-up HEP surveys. Results included 1.65 black-capped chickadee HUs, 280.57 great blue heron HUs, 581.45 Canada goose HUs, 40 mallard HUs, and 32.80 mink HUs. Introduction A follow-up Habitat Evaluation Procedures (HEP) (USFWS 1980) analysis was conducted by the Columbia Basin Fish and Wildlife Authority's (CBFWA) Regional HEP Team (RHT) during April and May 2007 to document changes in habitat quality and to determine the number of habitat units (HUs) to credit Bonneville Power Administration (BPA) for providing operation and maintenance (O&M) funds since WDFW acquired the parcels. The 2007 follow-up HEP evaluation was limited to Shillapoo Wildlife Area (SWA) parcels purchased with Bonneville Power Administration funds. D. Budd (pers. comm.) reported WDFW purchased the 612 acre Egger Farms parcel on November 2, 1998 for $1,737,0001 and the 210 acre Herzog acquisition on June 21, 2001 for $500,000 with Memorandum of Agreement funds (BPA and WDFW 1996) as partial fulfillment of BPA's wildlife mitigation obligation for construction of Bonneville and John Day Dams (Rasmussen and Wright 1989). Anticipating the eventual acquisition of the Egger and Herzog properties, WDFW conducted HEP surveys on these lands in 1994 to determine the potential number of habitat units to be credited to BPA. As a result, HEP surveys and habitat unit calculations were completed as much as seven years prior to acquiring the sites. The term 'Shillapoo Wildlife Area' will be used to describe only the Herzog and Egger parcels in this

  2. Follow-up of young road accident victims.

    Science.gov (United States)

    Gillies, Marjorie L; Barton, Joanne; Di Gallo, Alain

    2003-10-01

    The aim of this study was to follow-up a group of children and young people previously examined for psychological sequelae following road traffic accidents. The group was assessed 18-month postaccident to assess the severity of continuing symptoms and examine any emergence of delayed onset of posttraumatic stress reactions. Participants (N = 31) completed the Revised Impact of Event Scale and the Child Posttraumatic Stress Reaction Index. Parents completed the Child Behavior Check-List and participated in a semistructured interview. Symptoms of PTSD were noted in a quarter of participants as was delayed onset of symptoms. The role of avoidance in symptom reporting and continuing disorder is discussed.

  3. Automated medical follow-up and delayed industrial risks

    International Nuclear Information System (INIS)

    Smith, M.E.

    In response to increasing demand for human data to identify social, environmental, and occupational influences upon health, Statistics Canada has been organizing existing files of vital and health records to facilitate such studies on a national scale. In particular, the development of a Canadian Mortality Data Base file, the initiation of the National Cancer Incidence system, and the development of new computer techniques have helped reduce the cost and increase the scale and efficiency of automated medical follow-up to produce statistics of sickness or death attributable to environmental factors. Specific occupational studies now in progress serve to illustrate the methods, practical difficulties, potential size, and products from such investigations

  4. Destructive spondyloarthropathy and radiographic follow-up in hemodialysis patients

    International Nuclear Information System (INIS)

    Orzincolo, C.; Cardona, P.; Bedani, P.L.; Gilli, P.; Scutellari, P.N.; Trotta, F.

    1990-01-01

    Nine patients undergoing regular dialytic treatment for more than 60 months showed clinical and radiologic features of a noninfective and destructive spondyloarthropathy. Typically, radiographs and CT scans revealed narrowing of intervertebral spaces, with destruction or sclerosis of the subchondral bone of the vertebral plate. A radiographic follow-up of the cervical spine was performed in seven patients after a period of 12 months and showed that the bone destruction in DSA is very rapid and progressive. The lower biocompatibility of the cuprophan membranes of dialyzers is probably the factor most responsible for hyperproduction of β 2 -m and subsequently osteoarticular deposition of a new type of amyloidosis. (orig./DG)

  5. Simplified method evaluation for piping elastic follow-up

    International Nuclear Information System (INIS)

    Severud, L.K.

    1983-05-01

    A proposed simplified method for evaluating elastic follow-up effects in high temperature pipelines is presented. The method was evaluated by comparing the simplified analysis results with those obtained from detailed inelastic solutions. Nine different pipelines typical of a nuclear breeder reactor power plant were analyzed; the simplified method is attractive because it appears to give fairly accurate and conservative results. It is easy to apply and inexpensive since it employs iterative elastic solutions for the pipeline coupled with the readily available isochronous stress-strain data provided in the ASME Code

  6. Omega-3 fatty acid monotherapy for pediatric bipolar disorder: a prospective open-label trial.

    Science.gov (United States)

    Wozniak, Janet; Biederman, Joseph; Mick, Eric; Waxmonsky, James; Hantsoo, Liisa; Best, Catherine; Cluette-Brown, Joanne E; Laposata, Michael

    2007-01-01

    To test the effectiveness and safety of omega-3 fatty acids (Omegabrite(R) brand) in the treatment of pediatric bipolar disorder (BPD). Subjects (N=20) were outpatients of both sexes, 6 to 17 years of age, with a DSM-IV diagnosis of BPD and Young Mania Rating Scale (YMRS) score of >15 treated over an 8-week period in open-label trial with omega-3 fatty acids 1290 mg-4300 mg combined EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). Subjects experienced a statistically significant but modest 8.9+/-2.9 point reduction in the YMRS scores (baseline YMRS=28.9+/-10.1; endpoint YMRS=19.1+/-2.6, pDHA increased in treated subjects. As only 35% of these subjects had a response by the usual accepted criteria of >50% decrease on the YMRS, omega-3 fatty acids treatment was associated with a very modest improvement in manic symptoms in children with BPD.

  7. An open-label naturalistic pilot study of acamprosate in youth with autistic disorder.

    Science.gov (United States)

    Erickson, Craig A; Early, Maureen; Stigler, Kimberly A; Wink, Logan K; Mullett, Jennifer E; McDougle, Christopher J

    2011-12-01

    To date, placebo-controlled drug trials targeting the core social impairment of autistic disorder (autism) have had uniformly negative results. Given this, the search for new potentially novel agents targeting the core social impairment of autism continues. Acamprosate is U.S. Food and Drug Administration-approved drug to treat alcohol dependence. The drug likely impacts both gamma-aminobutyric acid and glutamate neurotransmission. This study describes our initial open-label experience with acamprosate targeting social impairment in youth with autism. In this naturalistic report, five of six youth (mean age, 9.5 years) were judged treatment responders to acamprosate (mean dose 1,110 mg/day) over 10 to 30 weeks (mean duration, 20 weeks) of treatment. Acamprosate was well tolerated with only mild gastrointestinal adverse effects noted in three (50%) subjects.

  8. Follow-up at the corrected age of 24 months of preterm newborns receiving continuous infusion of fentanyl for pain control during mechanical ventilation.

    Science.gov (United States)

    Ancora, Gina; Lago, Paola; Garetti, Elisabetta; Pirelli, Anna; Merazzi, Daniele; Pierantoni, Luca; Ferrari, Fabrizio; Faldella, Giacomo

    2017-05-01

    The neurodevelopmental impact of fentanyl given to preterm newborns for pain control is still unknown. The aim of this study was to assess the neurodevelopmental impact of 2 regimens of fentanyl administration by a prospective follow-up evaluation. In our previous multicenter, double-blind, randomized controlled trial, 131 mechanically ventilated newborns (gestational age ≤32 weeks) were randomized to fentanyl (continuous infusion of fentanyl + open label boluses of fentanyl) or placebo (continuous infusion of placebo + open label boluses of fentanyl). Infant development was evaluated using Griffiths Mental Developmental Scales (Griffiths, 1996) until 24 months of corrected age by trained psychologists who were not aware of the group allocation. 106/131 infants survived at discharge; 3 died after discharge, 25 were lost to follow-up (12 in the fentanyl and 13 in the placebo group). Seventy-eight patients were evaluated at 2 years of corrected age. Children in the fentanyl group, compared with those in the placebo group, obtained significantly lower Griffiths general developmental quotient (mean [SD]: 89.95 [13.64] vs 97.18 [12.72], P = 0.024) together with the scores on the eye-hand coordination (mean [SD]: 89.09 [12.13] vs 99.19 [13.19], P = 0.002) and performance skills (mean [SD]: 79.71 [15.80] vs 90.09 [15.28], P = 0.009) scales. After adjustment for clinical confounders (gestational age, CRIB score, and sex) only eye-hand co-ordination was associated with fentanyl infusion. This study demonstrates that continuous infusion of fentanyl in very preterm infants, given at 1 mcg·kg·h during mechanical ventilation, is associated with a significant decrease in eye and hand co-ordination skills. Longer follow-up is needed to evaluate the impact on future motor, cognitive, and behavioral functions.

  9. Deconstructing tolerance with clobazam: Post hoc analyses from an open-label extension study.

    Science.gov (United States)

    Gidal, Barry E; Wechsler, Robert T; Sankar, Raman; Montouris, Georgia D; White, H Steve; Cloyd, James C; Kane, Mary Clare; Peng, Guangbin; Tworek, David M; Shen, Vivienne; Isojarvi, Jouko

    2016-10-25

    To evaluate potential development of tolerance to adjunctive clobazam in patients with Lennox-Gastaut syndrome. Eligible patients enrolled in open-label extension study OV-1004, which continued until clobazam was commercially available in the United States or for a maximum of 2 years outside the United States. Enrolled patients started at 0.5 mg·kg -1 ·d -1 clobazam, not to exceed 40 mg/d. After 48 hours, dosages could be adjusted up to 2.0 mg·kg -1 ·d -1 (maximum 80 mg/d) on the basis of efficacy and tolerability. Post hoc analyses evaluated mean dosages and drop-seizure rates for the first 2 years of the open-label extension based on responder categories and baseline seizure quartiles in OV-1012. Individual patient listings were reviewed for dosage increases ≥40% and increasing seizure rates. Data from 200 patients were included. For patients free of drop seizures, there was no notable change in dosage over 24 months. For responder groups still exhibiting drop seizures, dosages were increased. Weekly drop-seizure rates for 100% and ≥75% responders demonstrated a consistent response over time. Few patients had a dosage increase ≥40% associated with an increase in seizure rates. Two-year findings suggest that the majority of patients do not develop tolerance to the antiseizure actions of clobazam. Observed dosage increases may reflect best efforts to achieve seizure freedom. It is possible that the clinical development of tolerance to clobazam has been overstated. NCT00518713 and NCT01160770. This study provides Class III evidence that the majority of patients do not develop tolerance to clobazam over 2 years of treatment. © 2016 American Academy of Neurology.

  10. Laserlight cues for gait freezing in Parkinson's disease: an open-label study.

    Science.gov (United States)

    Donovan, S; Lim, C; Diaz, N; Browner, N; Rose, P; Sudarsky, L R; Tarsy, D; Fahn, S; Simon, D K

    2011-05-01

    Freezing of gait (FOG) and falls are major sources of disability for Parkinson's disease (PD) patients, and show limited responsiveness to medications. We assessed the efficacy of visual cues for overcoming FOG in an open-label study of 26 patients with PD. The change in the frequency of falls was a secondary outcome measure. Subjects underwent a 1-2 month baseline period of use of a cane or walker without visual cues, followed by 1 month using the same device with the laserlight visual cue. The laserlight visual cue was associated with a modest but significant mean reduction in FOG Questionnaire (FOGQ) scores of 1.25 ± 0.48 (p = 0.0152, two-tailed paired t-test), representing a 6.6% improvement compared to the mean baseline FOGQ scores of 18.8. The mean reduction in fall frequency was 39.5 ± 9.3% with the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods (p = 0.002; two-tailed one-sample t-test with hypothesized mean of 0). Though some individual subjects may have benefited, the overall mean performance on the timed gait test (TGT) across all subjects did not significantly change. However, among the 4 subjects who underwent repeated testing of the TGT, one showed a 50% mean improvement in TGT performance with the laserlight visual cue (p = 0.005; two-tailed paired t-test). This open-label study provides evidence for modest efficacy of a laserlight visual cue in overcoming FOG and reducing falls in PD patients. Copyright © 2010 Elsevier Ltd. All rights reserved.

  11. An open-label study of sodium oxybate in Spasmodic dysphonia.

    Science.gov (United States)

    Rumbach, Anna F; Blitzer, Andrew; Frucht, Steven J; Simonyan, Kristina

    2017-06-01

    Spasmodic dysphonia (SD) is a task-specific laryngeal dystonia that affects speech production. Co-occurring voice tremor (VT) often complicates the diagnosis and clinical management of SD. Treatment of SD and VT is largely limited to botulinum toxin injections into laryngeal musculature; other pharmacological options are not sufficiently developed. Open-label study. We conducted an open-label study in 23 SD and 22 SD/VT patients to examine the effects of sodium oxybate (Xyrem), an oral agent with therapeutic effects similar to those of alcohol in these patients. Blinded randomized analysis of voice and speech samples assessed symptom improvement before and after drug administration. Sodium oxybate significantly improved voice symptoms (P = .001) primarily by reducing the number of SD-characteristic voice breaks and severity of VT. Sodium oxybate further showed a trend for improving VT symptoms (P = .03) in a subset of patients who received successful botulinum toxin injections for the management of their SD symptoms. The drug's effects were observed approximately 30 to 40 minutes after its intake and lasted about 3.5 to 4 hours. Our study demonstrated that sodium oxybate reduced voice symptoms in 82.2% of alcohol-responsive SD patients both with and without co-occurring VT. Our findings suggest that the therapeutic mechanism of sodium oxybate in SD and SD/VT may be linked to that of alcohol, and as such, sodium oxybate might be beneficial for alcohol-responsive SD and SD/VT patients. 4 Laryngoscope, 127:1402-1407, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

  12. Follow up study of Alzheimer's type dementia with computed tomography

    International Nuclear Information System (INIS)

    Hirata, Nobuhide

    1987-01-01

    In 54 patients who were diagnosed as having Alzheimer's type dementia based on the Diagnostic and Statistical Manual of Mental Disorders, III, cranial computed tomography (CT) scans were obtained before and after their follow-up study ranging from 6 to 24 months (mean 15.4 +- 4.7 months). Cerebrospinal percentage and CT density in various regions of interest were examined. Six patients died during the study. Comparison of the group of the deceased (Group I) with the group of survivors (Group II) revealed: (1) there was no difference in average age and the degree of mental disorder at first presentation; (2) Group I had decreased activities of daily living; and (3) CT density was significantly decreased in the bilateral lateral and frontal lobes in Group I. As for Group II, decreased CT numbers were noticeable during the follow-up period in the frontal lobe, parietal lobe, and caudate nucleus in the group evaluated as aggravated, as compared with the group evaluated as unchanged. (Namekawa, K.)

  13. Rothmund-Thomson Syndrome: A 13-Year Follow-Up

    Directory of Open Access Journals (Sweden)

    Guillermo Antonio Guerrero-González

    2014-07-01

    Full Text Available Rothmund-Thomson syndrome (RTS is a rare autosomal recessive disorder presenting with poikiloderma and other clinical features, affecting the bones and eyes and, in type II RTS, presenting an increased risk for malignancy. With about 300 cases reported so far, we present a 13-year follow-up including clinical images, X-rays and genetic analysis. A 13-month-old female started with a facial rash with blisters on her cheeks and limbs at the age of 3 months along with congenital hypoplastic thumbs, frontal bossing and fine hair, eyebrows and eyelashes. The patient was lost to follow-up and returned 12 years later with palmoplantar hyperkeratotic lesions, short stature, disseminated poikiloderma and sparse scalp hair, with absence of eyelashes and eyebrows. Radiographic analysis showed radial ray defect, absence of the thumb and three wrist carpal bones, and reduced bone density. Gene sequencing for the RECQL4 helicase gene revealed a mutation on each allele. RTS is a rare disease, and in this patient we observed the evolution of her skin lesions and other clinical features, which were important for the classification of type II RTS. The next years will provide even more information on this rare disease.

  14. [Follow-up of children conceived by assisted reproductive technologies].

    Science.gov (United States)

    Bouillon, C; Fauque, P

    2013-05-01

    Since the birth of the first baby conceived by in vitro fertilization (IVF) 30 years ago (Louise Brown in 1978), there has been a rapid and constant increase in the number of couples using assisted reproductive technologies (ART). Around four million of children have been born from couples experiencing fertility problems, through the use of ART, comprising roughly 2-3 % of all births in Europe and U.S. That highlights that these modes of fertilization are now well assumed by our societies. However, several questions on health of these children remain to be elucidated. As evoked in this review, even if methodological limitations exist, numerous studies have reported increased risks of birth defects, like prematurity, foetal hypotrophy, neonatal complications, congenital malformations and epigenetic diseases among ART-conceived children as compared to naturally conceived children. Nowadays, it is difficult to determine if these increased risks found in ART infants are a consequence of the ART procedures or are inherent to the infertility problems per se. However, absolute risks remain moderate and reassuring as well as the data on follow-up into infancy and early childhood. Nevertheless, because the effects may occur at the adulthood, there is a need for long-term follow-up of children born after ART. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  15. Follow-up of pulmonary perfusion recovery after embolism

    International Nuclear Information System (INIS)

    Palla, A.; Donnamaria, V.; Petruzzelli, S.; Giuntini, C.

    1986-01-01

    Blood flow recovery in a group of 69 patients with pulmonary embolism was followed by serial lung scans over a six month period. Each patient underwent perfusion lung scan at diagnosis then 7, 30 and 180 days later; i.v. heparin was systematically administered for one week after diagnosis, followed by oral warfarin for six months. Blood flow impairment was evaluated by assessing the total number of unperfused lung segments (ULS), as calculated on both lateral views at each scan. The number of ULS was significantly reduced at each interval (P<0.001), ranging from 8.4±3.3 at diagnosis to 3.6±2.7 six months later; most of the recovery (79%) occurred within the first month. No patient had complete restoration of pulmonary blood flow during the whole follow-up period. No difference was found between the number of ULS in right lung versus that in left lung at each interval. Recovery of blood flow was heavily affected by coexisting cardiac or pulmonary disease. In fact, those patients with underlying cardiopulmonary disease (49.2% of the total) showed significantly smaller perfusion improvement after six months (P<0.001). Eight patients (6 with and 2 without cardiopulmonary disease) had clinical and scintigraphic evidence of recurrent embolism during the follow-up period

  16. Gastric and Duodenal Stents: Follow-Up and Complications

    International Nuclear Information System (INIS)

    Pinto Pabon, Isabel Teresa; Paul Diaz, Laura; Ruiz de Adana, Juan Carlos; Lopez Herrero, Julio

    2001-01-01

    Purpose: To assess the efficacy of self-expanding metallic stents in treating inoperable gastric and duodenal stenoses during follow-up and to evaluate the complications encountered.Methods: A total of 31 patients suffering from gastroduodenal obstruction (29 malignant, 2 benign) were treated with a self-expanding metallic stent (Wallstent). In 24 cases insertion was by the peroral route, in seven cases via gastrostomy.Results: All the strictures were successfully negotiated under fluoroscopic guidance without having to resort to endoscopy. A total of 27 patients (87%) were able to resume a regular diet, a soft diet, or a liquid diet orally. Complications included one case of stent malpositioning, one case of leakage of ascitic fluid through the gastrostomy orifice, one case of perforation and fistula to the biliary tree, and two cases of hematemesis. In two patients (6%) additional stents were implanted to improve patency. In all patients follow-up was maintained until death. Recurrence of symptoms immediately before death occurred in seven cases (23%). Mean survival time of patients was 13.3 weeks (SE ± 4.6).Conclusions: The deployment of gastroduodenal stents resulted in good palliation of inoperable gastric and duodenal stenoses. Certain technical aspects, e.g., adaptation of stents to bowel morphology, is critical to proper stent function and avoidance of complications

  17. CT follow-up after radiation therapy for pituitary adenomas

    International Nuclear Information System (INIS)

    Rush, S.C.; Newall, J.

    1988-01-01

    Between 1973 and 1985, 105 patients received radiation therapy as all or part of their treatment for pituitary tumor at the New York University Medical Center. Of these, 48 patients underwent computed tomography (CT) at a minimum of 2 years following treatment, with detailed reports available for analysis of tumor regression. There were 28 men with a median age of 46 years (range, 18-71 years) and 20 women with a median age of 53 years (range, 28-80 years). Tumors were classified as secretory in 23 patients, nonsecretory in 21, and undetermined in four. Sixteen patients were treated with radiation therapy alone, 23 patients with surgery and radiation therapy, and the other with bromocriptine and radiation therapy, with or without surgery. With a median follow-up of 5 years (range, 2-14 years), 16 patients developed an empty sella, 25 patients had residual sellar mass, and seven patients had persistent extrasellar components or no change in their intrasellar mass. Among patients who did not have hypopituitarism at the inception of radiation therapy, five of 13 with empty sellas and 12 of 22 with residual mass subsequently required therapy. The authors conclude that residual mass is commonly found in long-term follow-up after radiation therapy, that isolated imaging studies revealing such findings after treatment in no way herald a diagnosis of recurrence, and that hypopituitarism following pituitary radiation therapy does not correlate with the ablation or persistence of tissue within the sella

  18. Antidepressant effectiveness of deep Transcranial Magnetic Stimulation (dTMS) in patients with Major Depressive Disorder (MDD) with or without Alcohol Use Disorders (AUDs): a 6-month, open label, follow-up study.

    Science.gov (United States)

    Rapinesi, Chiara; Curto, Martina; Kotzalidis, Georgios D; Del Casale, Antonio; Serata, Daniele; Ferri, Vittoria Rachele; Di Pietro, Simone; Scatena, Paola; Bersani, Francesco Saverio; Raccah, Ruggero Nessim; Digiacomantonio, Vittorio; Ferracuti, Stefano; Bersani, Giuseppe; Zangen, Abraham; Angeletti, Gloria; Girardi, Paolo

    2015-03-15

    Co-occurrence of Major Depressive (MDD) and Alcohol Use Disorders (AUDs) is frequent, causing more burden than each disorder separately. Since the dorsolateral prefrontal cortex (DLPFC) is critically involved in both mood and reward and dysfunctional in both conditions, we aimed to evaluate the effects of dTMS stimulation of bilateral DLPFC with left prevalence in patients with MDD with or without concomitant AUD. Twelve MDD patients and 11 with concomitant MDD and AUD (MDD+AUD) received 20 dTMS sessions. Clinical status was assessed through the Hamilton Depression Rating Scale (HDRS) and the Clinical Global Impressions severity scale (CGIs), craving through the Obsessive Compulsive Drinking Scale (OCDS) in MDD+AUD, and functioning with the Global Assessment of Functioning (GAF). There were no significant differences between the two groups in sociodemographic (age, sex, years of education and duration of illness) and baseline clinical characteristics, including scores on assessment scales. Per cent drops on HDRS and CGIs scores at the end of the sessions were respectively 62.6% and 78.2% for MDD+AUD, and 55.2% and 67.1% for MDD (pdepressive episodes. The potential use of dTMS for mood modulation as an adjunct to treatment in patients with a depressive episode, with or without alcohol abuse, deserves further investigation. Copyright © 2014 Elsevier B.V. All rights reserved.

  19. Follow-up of breast cancer by bone scintigraphy

    International Nuclear Information System (INIS)

    Garcia N, E.; Castro, F.; Miranda, R.; Leon, L.; Bustamante, G.; Escobar, M.

    2004-01-01

    Full text: Breast cancer is one of the most common cancers in women. It is the second most widespread cancer in Mexican women. Among the several methods for diagnosis and follow up of the disease, tumor markers like CA-53 have high sensitivity and specificity. Bone scan is a useful method in the detection of bone metastases. In comparison to other diagnostic modalities, bone scan is more sensitive and less expensive for detection of early bone abnormalities and hence to select an appropriate treatment for better prognosis. In our country, in about 70% of cases diagnosis of breast cancer is made when the disease is in an advanced state - states III and IV. The aim of this study was to evaluate the follow up of breast cancer by bone scans and to correlate these findings with the stage of the disease and other diagnostic modalities. The work was carried out at Mexican General Hospital. A total of 350 patients with breast tumor were included; bone scans were performed in all patients at the time of clinical diagnosis and at every 6 months for a period of 1 to 5 years using an Elscint APEX SP6 HR gamma camera coupled with ultra high resolution collimator. Scan was performed 2-3 hours after intravenous administration of 555-925 MBq of Tc-99m methyl diphosphonate. Tumor classification was made according to TNM criteria. Serum levels of alkaline phosphates, carcino-embrionic antigen (CEA) and Ca 53 were also measured on the same day. Fifty-one patients confirmed to have a diagnosis of benign breast were excluded from the study group. Of the remaining 299 patients, 89 (39%) were between 41 years to 50 years, 69 between 51 to 60 years. The clinical stage most commonly observed was stage III (n=164, 54%) followed by stage II (25%). In 59.5% of patients, scintigraphy showed bone metastasis. Four patients with bone metastases showed regression and 42 (14%) with negative scans became positive on follow up bone scans. Ninety-three patients were free of bone metastases during all

  20. Long term follow up of medical therapy of thyroid cancer

    International Nuclear Information System (INIS)

    Jaffiol, C.; Daures, J.P.; Nsakala, N.; Guerenova, J.; Baldet, L.; Pujol, P.; Vannereau, D.; Bringer, J.

    1995-01-01

    106 patients, 114 W, 27 M, were thyroidectomized for differentiated thyroid cancer (follicular 29.3% - papillary 54.3%) with different stages of gravity (N O: 48.2% - N 1: 32.8% - N 2: 19%). Neck dissection was used in cases of involved nodes. One or several doses of 131 I were given to 126 subjects, 106 patients were treated with L thyroxine (LT4) (mean daily dose: 2.5 μg/kg BW). 23 patients presenting intolerance to LT4 with non suppressed TSH for 13 of them were treated by an association of tiratricol (TRIAC) + LT4. The follow up included a yearly check up involving clinical examination, plasma thyroglobulin (Tg) and thyroid stimulating hormone (TSH) assessment, neck ultrasonography and X ray of the chest. Therapy was stopped for 4 weeks in cases with Tg above its detectable value and a total body scan performed with Tg and TSH controls. The mean duration of follow up was 94.5 ± 67.7 months and extended to more than 5 years for 61% of the patients. We observed 22 relapses of the tumor with 4 deaths. Age less then 45 years, appears as the best factor of prognosis. 2 groups of patients were compared to evaluate the incidence of TSH suppression on the relapse free survival (group 1 n = 30 with a TSH ≤ 0.10 mU/1 and group 2 n = 15 with a TSH always > 1 mU/1 during the follow up). The relapse free survival was shorter in group 2 (p 0.01). Association of TRIAC with LT4 leads to a reduction of the daily dose of LT4 (m 25μg/day) with a significant improvement of TSH suppression and clinical tolerance. In conclusion, TSH suppression improves the prognosis in thyroidectomized patients for differentiated carcinoma. Association of TRIAC with LT4 seems able to approve TSH suppression and therapeutic tolerance. (authors). 40 refs., 5 tabs

  1. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients.

    Science.gov (United States)

    Pacik, Peter T; Geletta, Simon

    2017-06-01

    Vaginismus is mostly unknown among clinicians and women. Vaginismus causes women to have fear, anxiety, and pain with penetration attempts. To present a large cohort of patients based on prior published studies approved by an institutional review board and the Food and Drug Administration using a comprehensive multimodal vaginismus treatment program to treat the physical and psychologic manifestations of women with vaginismus and to record successes, failures, and untoward effects of this treatment approach. Assessment of vaginismus included a comprehensive pretreatment questionnaire, the Female Sexual Function Index (FSFI), and consultation. All patients signed a detailed informed consent. Treatment consisted of a multimodal approach including intravaginal injections of onabotulinumtoxinA (Botox) and bupivacaine, progressive dilation under conscious sedation, indwelling dilator, follow-up and support with office visits, phone calls, e-mails, dilation logs, and FSFI reports. Logs noting dilation progression, pain and anxiety scores, time to achieve intercourse, setbacks, and untoward effects. Post-treatment FSFI scores were compared with preprocedure scores. One hundred seventy-one patients (71%) reported having pain-free intercourse at a mean of 5.1 weeks (median = 2.5). Six patients (2.5%) were unable to achieve intercourse within a 1-year period after treatment and 64 patients (26.6%) were lost to follow-up. The change in the overall FSFI score measured at baseline, 3 months, 6 months, and 1 year was statistically significant at the 0.05 level. Three patients developed mild temporary stress incontinence, two patients developed a short period of temporary blurred vision, and one patient developed temporary excessive vaginal dryness. All adverse events resolved by approximately 4 months. One patient required retreatment followed by successful coitus. A multimodal program that treated the physical and psychologic aspects of vaginismus enabled women to achieve

  2. Mammographic follow-up after conservation therapy for breast cancer

    International Nuclear Information System (INIS)

    Gu Yajia; Xiao Qin; Zheng Xiaojing; Wu Jiong; Chen Jiayi; Gu Rongfeng; Feng Xiaoyuan

    2006-01-01

    Objective: To recognize the mammographic changes after conservation therapy for breast carcinoma. Methods: A total of 139 follow-up mammographic examinations in 85 cases were studied during the period between 1999 and 2004. Mammography was performed at intervals of 6 months for the first 2 years, then annually. Attention was paid to mammographic change patterns of conservation therapy for breast carcinoma, including breast edema, skin thickening, architectural disturbance, asymmetric density, architectural distortion retraction, and calcifications. SPSS version 11.0 for windows was used to perform all statistical tests. Kruskal-Wallis H test was used for calculating the overall statistical differences between difference periods. Categorical data were expressed as percentages and analyzed by using the X 2 test. The age of the patients ranged from 25 to 63 years (mediate, 44 years old). The time of follow-up observation ranged from 1 week to 72 months. Results: Two cases were normal on mammograms. High proportion of abnormal mammography was seen in the period of 12 month (40.3%, 56/139) and 24 month (21.6%, 30/139), respectively. Various findings appeared in various periods and the difference was statistically significant(X 2 =30.998, v=6, P=0.001). Mild edema appeared in the first 3 years. Moderately severe or marked breast edema may be present between 6 months to 12 months, then slowly resolved. The appearance and disappearance of skin thickening were similar to the process of breast edema. The changes of architectural disturbance did not correlate with time (X 2 =8.634, P>0.05), but on sequential mammograms for same patient, the extent of architectural disturbance relieved over time (17/19). Asymmetric density was found in only 5 patients, and disappeared in later period of follow-up in 3. Architectural distortion retraction got more and more obvious with time, and kept stable after certain period of time. Calcifications were shown in 2 patients, including 1

  3. Role of imaging in glaucoma diagnosis and follow-up

    Directory of Open Access Journals (Sweden)

    Vizzeri Gianmarco

    2011-12-01

    Full Text Available The purpose of the review is to provide an update on the role of imaging devices in the diagnosis and follow-up of glaucoma with an emphasis on techniques for detecting glaucomatous progression and the newer spectral domain optical coherence tomography instruments. Imaging instruments provide objective quantitative measures of the optic disc and the retinal nerve fiber layer and are increasingly utilized in clinical practice. This review will summarize the recent enhancements in confocal scanning laser ophthalmoscopy, scanning laser polarimetry, and optical coherence tomography with an emphasis on how to utilize these techniques to manage glaucoma patients and highlight the strengths and limitations of each technology. In addition, this review will briefly describe the sophisticated data analysis strategies that are now available to detect glaucomatous change overtime.

  4. Patients’ Vulnerability in Follow-up After Colorectal Cancer

    DEFF Research Database (Denmark)

    Thomsen, Thora Grothe; Hølge-Hazelton, Bibi

    2017-01-01

    and reorganizing follow-up after cancer treatment. OBJECTIVE:: The aim of this study was to identify the perspectives of fast-track colorectal cancer surgery patients on challenges experienced in the transition from being a hospitalized patient with cancer to being a cancer survivor. METHODS:: The current article......BACKGROUND:: In the transition between being a hospitalized patient with cancer and resuming “normal” life, many patients experience physical, mental, and social challenges. Scientifically, as well as politically, it is therefore recommended to undertake research with a focus on rethinking...... hospital after a few days; however, shortly after returning home, most of them became mentally overwhelmed by the feeling of vulnerability that was closely related to the feeling of being handed over the responsibility for a newly cancer-operated body and a fragile life situation. Four issues...

  5. Scintigraphic follow-up of fracture healing in animals

    International Nuclear Information System (INIS)

    Klug, W.; Franke, W.G.; Schulze, M.

    1983-01-01

    Secondary bone fracture heating was analysed by scintigraphic follow-up studies in rabbits using sup(99m)Tc-HEDP. 24 hours after fracture the activity ratio between the fractured and the non-fractured lower limb was 2,2. The maximal count density in the fracture region is found during the 14th and 28th day after fracture. Concomitantly there is a significant increase of bone marrow vessels and content of copper, magnesium, sodium and water in the callus. Although roentgenographic controls and static investigations with respect to consolidation reveal a complete heating already 126 days after fracture, the complete scintigraphic normalisation of the lower limb fracture of the rabbit is found not earlier than at the 203rd day after fracture. (orig.) [de

  6. Scintigraphic follow-up of fracture healing in animals

    Energy Technology Data Exchange (ETDEWEB)

    Klug, W.; Franke, W.G.; Schulze, M.

    1983-08-01

    Secondary bone fracture healing was analysed by scintigraphic follow-up studies in rabbits using sup(99m)Tc-HEDP. 24 hours after fracture the activity ratio between the fractured and the non-fractured lower limb was 2,2. The maximal count density in the fracture region is found during the 14th and 28th day after fracture. Concomitantly there is a significant increase of bone marrow vessels and content of copper, magnesium, sodium and water in the callus. Although roentgenographic controls and static investigations with respect to consolidation reveal a complete healing already 126 days after fracture, the complete scintigraphic normalisation of the lower limb fracture of the rabbit is found not earlier than at the 203rd day after fracture.

  7. Epidemiological follow-up study of Japanese Thorotrast cases

    International Nuclear Information System (INIS)

    Mori, T.; Maruyama, T.; Kato, Y.; Takahashi, S.

    1979-01-01

    The authors conducted a follow-up study on 243 Thorotrast-administered war-wounded ex-servicemen in 1975, after a lapse of 30 to 38 years from Thorotrast injections, and found 18 cases of malignant hepatic tumor, 15 cases of other malignant tumors, 2 cases of blood diseases, and 9 cases of liver cirrhosis in 224 cases who had been given Thorotrast intravascularly. The incidence of hepatic and other malignant tumors, blood diseases, and liver cirrhosis was significantly higher than in the controls. The total number of deaths in the Thorotrast-administered cases was also significantly higher than in the controls. In the remaining 19 cases who had been given Thorotrast by a route other than intravascularly, no fatal case related to Thorotrast administration was discovered. In the living cases, however, one sarcoma was observed to have developed at the site of the Thorotrast injection

  8. [Neuromuscular disease: respiratory clinical assessment and follow-up].

    Science.gov (United States)

    Martínez Carrasco, C; Villa Asensi, J R; Luna Paredes, M C; Osona Rodríguez de Torres, F B; Peña Zarza, J A; Larramona Carrera, H; Costa Colomer, J

    2014-10-01

    Patients with neuromuscular disease are an important group at risk of frequently suffering acute or chronic respiratory failure, which is their main cause of death. They require follow-up by a pediatric respiratory medicine specialist from birth or diagnosis in order to confirm the diagnosis and treat any respiratory complications within a multidisciplinary context. The ventilatory support and the cough assistance have improved the quality of life and long-term survival for many of these patients. In this paper, the authors review the pathophysiology, respiratory function evaluation, sleep disorders, and the most frequent respiratory complications in neuromuscular diseases. The various treatments used, from a respiratory medicine point of view, will be analyzed in a next paper. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  9. A follow-up of 72 cases referred for abortion.

    Science.gov (United States)

    Gillis, A

    1975-01-01

    Whilst the medical indications for therapeutic abortion and the legal limitations set vary enormously from one country to another there is in general an undoubted trend towards giving the pregnant woman herself a greater say in the decision. During the first year of the operation of the Abortion Act, 1967, in England some 72 pregnant women were referred to the author and his colleagues for a recommendation on abortion. A psychiatric examination and follow-up over a period of one year was made both in those cases where abortion was performed as well as in those cases who were refused therapeutic abortion. In this communication a comparison is made between the reactions and outcome in the two groups. A provisional conclusion is reached that no significant psychiatric disturbance could be attributed to the performance of the operation or on the other hand to refusal of the woman's request.

  10. Vertebral sarcoidosis: long-term follow-up with MRI

    Energy Technology Data Exchange (ETDEWEB)

    Lefere, M. [University Hospitals Gasthuisberg, Department of Radiology, Leuven (Belgium); Larbi, A.; Malghem, J.; Vande Berg, B.; Dallaudiere, B. [University Hospitals St Luc, Department of Radiology, Brussels (Belgium)

    2014-08-15

    Vertebral involvement in sarcoidosis is rare and its clinical and imaging features are non-specific. Indeed, because the lesions are hard to differentiate from metastatic disease based on imaging alone, a histological confirmation is advised. Fatty replacement is a well-known finding indicating stabilization and healing in both benign and malignant conditions. It can be used as an indicator of a favorable disease course and response to treatment. We report the case of a 43-year-old woman with multifocal vertebral sarcoidosis lesions and long-term follow-up showing progressive and gradual fatty involution on magnetic resonance imaging (MRI) during 4 years of steroid treatment with a final favorable outcome. (orig.)

  11. Hydrotherapy after total knee arthroplasty. A follow-up study.

    Science.gov (United States)

    Giaquinto, S; Ciotola, E; Dall'Armi, V; Margutti, F

    2010-01-01

    The study evaluated the subjective functional outcome following total knee arthroplasty (TKA) in participants who underwent hydrotherapy (HT) six months after discharge from a rehabilitation unit. A total of 70 subjects, 12 of which were lost at follow-up, were randomly assigned to either a conventional gym treatment (N=30) or HT (N=28). A prospective design was performed. Participants were interviewed with Western-Ontario McMasters Universities Osteoarthritis Index (WOMAC) at admission, at discharge and six months later. Kruskal-Wallis and Wilcoxon tests were applied for statistical analysis. Both groups improved. The WOMAC subscales, namely pain, stiffness and function, were all positively affected. Statistical analysis indicates that scores on all subscales were significantly lower for the HT group. The benefits gained by the time of discharge were still found after six months. HT is recommended after TKA in a geriatric population. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

  12. Magnetic resonance imaging in follow-up assessment of sciatica.

    Science.gov (United States)

    el Barzouhi, Abdelilah; Vleggeert-Lankamp, Carmen L A M; Lycklama à Nijeholt, Geert J; Van der Kallen, Bas F; van den Hout, Wilbert B; Jacobs, Wilco C H; Koes, Bart W; Peul, Wilco C

    2013-03-14

    Magnetic resonance imaging (MRI) is frequently performed during follow-up in patients with known lumbar-disk herniation and persistent symptoms of sciatica. The association between findings on MRI and clinical outcome is controversial. We studied 283 patients in a randomized trial comparing surgery and prolonged conservative care for sciatica and lumbar-disk herniation. Patients underwent MRI at baseline and after 1 year. We used a 4-point scale to assess disk herniation on MRI, ranging from 1 for "definitely present" to 4 for "definitely absent." A favorable clinical outcome was defined as complete or nearly complete disappearance of symptoms at 1 year. We compared proportions of patients with a favorable outcome among those with a definite absence of disk herniation and those with a definite, probable, or possible presence of disk herniation at 1 year. The area under the receiver-operating-characteristic (ROC) curve was used to assess the prognostic accuracy of the 4-point scores regarding a favorable or unfavorable outcome, with 1 indicating perfect discriminatory value and 0.5 or less indicating no discriminatory value. At 1 year, 84% of the patients reported having a favorable outcome. Disk herniation was visible in 35% with a favorable outcome and in 33% with an unfavorable outcome (P=0.70). A favorable outcome was reported in 85% of patients with disk herniation and 83% without disk herniation (P=0.70). MRI assessment of disk herniation did not distinguish between patients with a favorable outcome and those with an unfavorable outcome (area under ROC curve, 0.48). MRI performed at 1-year follow-up in patients who had been treated for sciatica and lumbar-disk herniation did not distinguish between those with a favorable outcome and those with an unfavorable outcome. (Funded by the Netherlands Organization for Health Research and Development and the Hoelen Foundation; Controlled Clinical Trials number, ISRCTN26872154.).

  13. SUBMILLIMETER FOLLOW-UP OF WISE-SELECTED HYPERLUMINOUS GALAXIES

    International Nuclear Information System (INIS)

    Wu Jingwen; Eisenhardt, Peter R. M.; Stern, Daniel; Assef, Roberto; Tsai, Chao-Wei; Cutri, Roc; Griffith, Roger; Jarrett, Thomas; Sayers, Jack; Bridge, Carrie; Benford, Dominic; Blain, Andrew; Petty, Sara; Lake, Sean; Bussmann, Shane; Comerford, Julia M.; Evans, Neal J. II; Lonsdale, Carol; Rho, Jeonghee; Stanford, S. Adam

    2012-01-01

    We have used the Caltech Submillimeter Observatory (CSO) to follow-up a sample of Wide-field Infrared Survey Explorer (WISE) selected, hyperluminous galaxies, the so-called W1W2-dropout galaxies. This is a rare (∼1000 all-sky) population of galaxies at high redshift (peaks at z = 2-3), which are faint or undetected by WISE at 3.4 and 4.6 μm, yet are clearly detected at 12 and 22 μm. The optical spectra of most of these galaxies show significant active galactic nucleus activity. We observed 14 high-redshift (z > 1.7) W1W2-dropout galaxies with SHARC-II at 350-850 μm, with nine detections, and observed 18 with Bolocam at 1.1 mm, with five detections. Warm Spitzer follow-up of 25 targets at 3.6 and 4.5 μm, as well as optical spectra of 12 targets, are also presented in the paper. Combining WISE data with observations from warm Spitzer and CSO, we constructed their mid-IR to millimeter spectral energy distributions (SEDs). These SEDs have a consistent shape, showing significantly higher mid-IR to submillimeter ratios than other galaxy templates, suggesting a hotter dust temperature. We estimate their dust temperatures to be 60-120 K using a single-temperature model. Their infrared luminosities are well over 10 13 L ☉ . These SEDs are not well fitted with existing galaxy templates, suggesting they are a new population with very high luminosity and hot dust. They are likely among the most luminous galaxies in the universe. We argue that they are extreme cases of luminous, hot dust-obscured galaxies (DOGs), possibly representing a short evolutionary phase during galaxy merging and evolution. A better understanding of their long-wavelength properties needs ALMA as well as Herschel data.

  14. Submillimeter Follow-up of Wise-Selected Hyperluminous Galaxies

    Science.gov (United States)

    Wu, Jingwen; Tsai, Chao-Wei; Sayers, Jack; Benford, Dominic; Bridge, Carrie; Blain, Andrew; Eisenhardt, Peter R. M.; Stern, Daniel; Petty, Sara; Assef, Roberto; hide

    2013-01-01

    We have used the Caltech Submillimeter Observatory (CSO) to follow-up a sample of Wide-field Infrared Survey Explorer (WISE) selected, hyperluminous galaxies, the so-called W1W2-dropout galaxies. This is a rare (approximately 1000 all-sky) population of galaxies at high redshift (peaks at zeta = 2-3), which are faint or undetected by WISE at 3.4 and 4.6 micrometers, yet are clearly detected at 12 and 22 micrometers. The optical spectra of most of these galaxies show significant active galactic nucleus activity. We observed 14 high-redshift (zeta greater than 1.7) W1W2-dropout galaxies with SHARC-II at 350-850 micrometers, with nine detections, and observed 18 with Bolocam at 1.1 mm, with five detections. Warm Spitzer follow-up of 25 targets at 3.6 and 4.5 micrometers, as well as optical spectra of 12 targets, are also presented in the paper. Combining WISE data with observations from warm Spitzer and CSO, we constructed their mid-IR to millimeter spectral energy distributions (SEDs). These SEDs have a consistent shape, showing significantly higher mid-IR to submillimeter ratios than other galaxy templates, suggesting a hotter dust temperature.We estimate their dust temperatures to be 60-120 K using a single-temperature model. Their infrared luminosities are well over 10(exp 13) solar luminosity. These SEDs are not well fitted with existing galaxy templates, suggesting they are a new population with very high luminosity and hot dust. They are likely among the most luminous galaxies in the universe.We argue that they are extreme cases of luminous, hot dust-obscured galaxies (DOGs), possibly representing a short evolutionary phase during galaxy merging and evolution. A better understanding of their long-wavelength properties needs ALMA as well as Herschel data.

  15. SUBMILLIMETER FOLLOW-UP OF WISE-SELECTED HYPERLUMINOUS GALAXIES

    Energy Technology Data Exchange (ETDEWEB)

    Wu Jingwen; Eisenhardt, Peter R. M.; Stern, Daniel; Assef, Roberto [Jet Propulsion Laboratory, California Institute of Technology, 4800 Oak Grove Drive, Pasadena, CA 91109 (United States); Tsai, Chao-Wei; Cutri, Roc; Griffith, Roger; Jarrett, Thomas [Infrared Processing and Analysis Center, California Institute of Technology, Pasadena, CA 91125 (United States); Sayers, Jack; Bridge, Carrie [Division of Physics, Math and Astronomy, California Institute of Technology, Pasadena, CA 91125 (United States); Benford, Dominic [NASA Goddard Space Flight Center, Greenbelt, MD 20771 (United States); Blain, Andrew [Department of Physics and Astronomy, University of Leicester, LE1 7RH Leicester (United Kingdom); Petty, Sara; Lake, Sean [Department of Physics and Astronomy, University of California Los Angeles, Los Angeles, CA 90095 (United States); Bussmann, Shane [Harvard-Smithsonian Center for Astrophysics, 60 Garden Street, MS78, Cambridge, MA 02138 (United States); Comerford, Julia M.; Evans, Neal J. II [Department of Astronomy, University of Texas, Austin, TX 78731 (United States); Lonsdale, Carol [National Radio Astronomy Observatory, 520 Edgemont Road, Charlottesville, VA 22903 (United States); Rho, Jeonghee [SETI Institute, 189 BERNARDO Avenue, Mountain View, CA 94043 (United States); Stanford, S. Adam, E-mail: jingwen.wu@jpl.nasa.gov [Department of Physics, University of California Davis, One Shields Avenue, Davis, CA 95616 (United States); and others

    2012-09-01

    We have used the Caltech Submillimeter Observatory (CSO) to follow-up a sample of Wide-field Infrared Survey Explorer (WISE) selected, hyperluminous galaxies, the so-called W1W2-dropout galaxies. This is a rare ({approx}1000 all-sky) population of galaxies at high redshift (peaks at z = 2-3), which are faint or undetected by WISE at 3.4 and 4.6 {mu}m, yet are clearly detected at 12 and 22 {mu}m. The optical spectra of most of these galaxies show significant active galactic nucleus activity. We observed 14 high-redshift (z > 1.7) W1W2-dropout galaxies with SHARC-II at 350-850 {mu}m, with nine detections, and observed 18 with Bolocam at 1.1 mm, with five detections. Warm Spitzer follow-up of 25 targets at 3.6 and 4.5 {mu}m, as well as optical spectra of 12 targets, are also presented in the paper. Combining WISE data with observations from warm Spitzer and CSO, we constructed their mid-IR to millimeter spectral energy distributions (SEDs). These SEDs have a consistent shape, showing significantly higher mid-IR to submillimeter ratios than other galaxy templates, suggesting a hotter dust temperature. We estimate their dust temperatures to be 60-120 K using a single-temperature model. Their infrared luminosities are well over 10{sup 13} L{sub Sun }. These SEDs are not well fitted with existing galaxy templates, suggesting they are a new population with very high luminosity and hot dust. They are likely among the most luminous galaxies in the universe. We argue that they are extreme cases of luminous, hot dust-obscured galaxies (DOGs), possibly representing a short evolutionary phase during galaxy merging and evolution. A better understanding of their long-wavelength properties needs ALMA as well as Herschel data.

  16. Clinical outcome and follow-up of prenatal hydronephrosis

    Directory of Open Access Journals (Sweden)

    Afshin Safaei Asl

    2012-01-01

    Full Text Available Hydronephrosis is probably the most common congenital abnormality detected prenatally by ultrasonography This study was performed to determine the cause and outcome of prenatal hydronephrosis in our hospital. A total of 45 infants, with 57 prenatally hydronephrotic renal units, were enrolled into this study. For the purpose of this study, the degree of hydronephrosis was defined as mild, moderate or severe. Postnatal ultrasonography was performed as soon as possible in those with bilateral hyronephrosis and 3-7 days after birth in those with unilateral hydronephrosis. Voiding cystourethrogram was performed in 6-8 weeks time. In the absence of vesicoureteral reflux (VUR, Diethylenetriamene penta acetate scan was performed to exclude obstructive uropathy. There were 29 males and 16 females (male:female ratio 1.8:1, and unilateral and bilateral hydronephrosis were seen in 33 (73% and 12 (27% of the cases, res-pectively. Hydronephrosis was caused by ureteropelvic junction obstruction (UPJO in 20 (44.5%, VUR in 10 (22.2%, ureterovesical junction obstruction in four (8.9 %, posteriorurethral valves in four (8.9 %, UPJO with VUR in two (4.4% and non-VUR non-obstructive in one (2.2%. During follow-up, 16 patients (35.5% required operative intervention while seven (15.5% improved spontaneously. Fetal hydronephrosis needs close follow-up during both ante-natal and postnatal periods. In this study, the most common cause for hydronephrosis were UPJO and VUR. Also seen in this study is the noteworthy point that mild fetal hydronephrosis is relatively benign and does not require surgical intervention in most cases and surgery should be performed only if there is renal function compromise. Prenatal consultation with a pediatric nephrologist and urologist is useful in decreasing parental anxiety and facilitating postnatal management.

  17. Follow up study and interested cases in subdural hematoma

    International Nuclear Information System (INIS)

    Kano, Mitsumasa; Goh, Jyunto; Koomura, Eiji; Nakao, Kazutami

    1983-01-01

    1. Out of 67 patients ranging from 16 to 82 years old, 20 were followed up by CT scan after operation. 2. Five patients presented hematoma on the both sides after operation, though they had suffered from the lesion of one side before operation. In four patients, hematoma was observed on the both sides before and after operation. Neither preoperative involved side changed nor hematoma appeared on the opposite side after operation in 11 patients. Follow-up examinations lasted up almost three months. 3. The maximum width of the subdural space was divided by the maximum intracranial width. These two factors were measured on horizontal CT scan. The calculated value was expressed in percentage and then, the result was regarded as Subdural Space (SDS) Index. Dividing a difference between the largest SDS Index (before operation) and the smallest by the number of days between the two points gave us a reduction rate of SDS Index. As a result, a reduction rate of 0.4 or less was obtained in all the patients less than 65 years old. There were three patients within the range from 0.7 to 1.0 of the rate. 76-year-old patients showed 2.6 and 5.7. Except the 76-old patients, mean duration of 35.5 days was calculated in Group I and SDS Index was 0, while Group II showed mean duration of 52.4 days, resulting in SDS Index of 0. 4. Specific progresses are shown below: 1) Hemorrhage of the caudate nucleus after operation 2) Subdural effusion of the both sides 3) Appearance of abscess 4) Subtentrial hemorrhage after operation 5) Postoperative epidural hematoma 6) Traumatic intracerebral hemorrhage, resulting in chronic subdural hematoma six months afterward (author)

  18. Long-term effects of ayahuasca in patients with recurrent depression: a 5-year qualitative follow-up

    Directory of Open Access Journals (Sweden)

    Rafael G. Dos Santos

    Full Text Available Abstract Background Ayahuasca is a botanical hallucinogenic preparation traditionally used by indigenous populations of Northwestern Amazonian countries for ritual and therapeutic purposes. It is rich in β-carboline alkaloids and N,N-dimethyltryptamine (DMT. Preclinical, observational, and experimental studies suggest that ayahuasca and its alkaloids have anxiolytic and antidepressive effects. We recently reported in an open-label trial that ayahuasca administration was associated with significant decreases in depression symptoms for 2-3 weeks after the experimental session in 17 patients with treatment-resistant major depressive disorder. Objectives To investigate if the experiment had any long-lasting effects on patients Methods Eight patients were interviewed 4 to 7 years after ayahuasca intake. Results Our results suggest that ayahuasca was well tolerated and that symptom reductions were limited to a few weeks. Importantly, most patients believed that the experience was among the most important of their lives, even 4-7 years later. Discussion To the best of our knowledge, this is the first long-term follow-up of a clinical sample that participated in an ayahuasca trial. Further studies with different and repeated dosing should be designed to further explore the antidepressive and anxiolytic effects of ayahuasca.

  19. Augmentation of light therapy in difficult-to-treat depressed patients: an open-label trial in both unipolar and bipolar patients

    Science.gov (United States)

    Camardese, Giovanni; Leone, Beniamino; Serrani, Riccardo; Walstra, Coco; Di Nicola, Marco; Della Marca, Giacomo; Bria, Pietro; Janiri, Luigi

    2015-01-01

    Objectives We investigated the clinical benefits of bright light therapy (BLT) as an adjunct treatment to ongoing psychopharmacotherapy, both in unipolar and bipolar difficult-to-treat depressed (DTD) outpatients. Methods In an open-label study, 31 depressed outpatients (16 unipolar and 15 bipolar) were included to undergo 3 weeks of BLT. Twenty-five completed the treatment and 5-week follow-up. Main outcome measures Clinical outcomes were evaluated by the Hamilton Depression Rating Scale (HDRS). The Snaith–Hamilton Pleasure Scale and the Depression Retardation Rating Scale were used to assess changes in anhedonia and psychomotor retardation, respectively. Results The adjunctive BLT seemed to influence the course of the depressive episode, and a statistically significant reduction in HDRS scores was reported since the first week of therapy. The treatment was well-tolerated, and no patients presented clinical signs of (hypo)manic switch during the overall treatment period. At the end of the study (after 5 weeks from BLT discontinuation), nine patients (36%, eight unipolar and one bipolar) still showed a treatment response. BLT augmentation also led to a significant improvement of psychomotor retardation. Conclusion BLT combined with the ongoing pharmacological treatment offers a simple approach, and it might be effective in rapidly ameliorating depressive core symptoms of vulnerable DTD outpatients. These preliminary results need to be confirmed in placebo-controlled, randomized, double-blind clinical trial on larger samples. PMID:26396517

  20. Metformin Treatment in Type 2 Diabetes in Pregnancy: An Active Controlled, Parallel-Group, Randomized, Open Label Study in Patients with Type 2 Diabetes in Pregnancy

    Directory of Open Access Journals (Sweden)

    Jahan Ara Ainuddin

    2015-01-01

    Full Text Available Aims. To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability. Methods. In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma. Results. Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P24 hours in metformin group (P<0.01. Significant reduction in cost of treatment was found in metformin group. Conclusion. Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.

  1. A Complex Multiherbal Regimen Based on Ayurveda Medicine for the Management of Hepatic Cirrhosis Complicated by Ascites: Nonrandomized, Uncontrolled, Single Group, Open-Label Observational Clinical Study.

    Science.gov (United States)

    Patel, Manish V; Patel, Kalapi B; Gupta, Shivenarain; Michalsen, Andreas; Stapelfeldt, Elmar; Kessler, Christian S

    2015-01-01

    Hepatic cirrhosis is one of the leading causes of death worldwide, especially if complicated by ascites. This chronic condition can be related to the classical disease entity jalodara in Traditional Indian Medicine (Ayurveda). The present paper aims to evaluate the general potential of Ayurvedic therapy for overall clinical outcomes in hepatic cirrhosis complicated by ascites (HCcA). In form of a nonrandomized, uncontrolled, single group, open-label observational clinical study, 56 patients fulfilling standardized diagnostic criteria for HCcA were observed during their treatment at the P. D. Patel Ayurveda Hospital, Nadiad, India. Based on Ayurvedic tradition, a standardized treatment protocol was developed and implemented, consisting of oral administration of single and compound herbal preparations combined with purificatory measures as well as dietary and lifestyle regimens. The outcomes were assessed by measuring liver functions through specific clinical features and laboratory parameters and by evaluating the Child-Pugh prognostic grade score. After 6 weeks of treatment and a follow-up period of 18 weeks, the outcomes showed statistically significant and clinically relevant improvements. Further larger and randomized trials on effectiveness, safety, and quality of the Ayurvedic approach in the treatment of HCcA are warranted to support these preliminary findings.

  2. Metformin treatment in type 2 diabetes in pregnancy: an active controlled, parallel-group, randomized, open label study in patients with type 2 diabetes in pregnancy.

    Science.gov (United States)

    Ainuddin, Jahan Ara; Karim, Nasim; Zaheer, Sidra; Ali, Syed Sanwer; Hasan, Anjum Ara

    2015-01-01

    To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability. In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma. Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P pregnancy induced hypertension (P = 0.029) were observed in metformin treated group. Small for date babies were more in metformin group (P 24 hours in metformin group (P metformin group. Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.

  3. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study.

    NARCIS (Netherlands)

    Leonardi, C.; Strober, B.; Gottlieb, A.B.; Elewski, B.E.; Ortonne, J.P.; Kerkhof, P.C.M. van de; Chiou, C.F.; Dunn, M.; Jahreis, A.

    2010-01-01

    BACKGROUND: In two previous phase 3 studies, up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis and was well tolerated. OBJECTIVE: To evaluate the long-term safety of etanercept in an open-label extension study for up to 72 weeks in patients with moderate-to-severe

  4. Six week open-label reboxetine treatment in children and adolescents with attention deficit hyperactivity disorder

    Directory of Open Access Journals (Sweden)

    Arabgol F

    2007-10-01

    Full Text Available Background: Attention Deficit Hyperactivity Disorder (ADHD is a common psychiatric disorder among children and adolescents. This disorder causes difficulties in academic, behavioral, emotional, social and family performance. Stimulants show robust efficacy and a good safety profile in children with this disorder, but a significant percent of ADHD children do not respond adequately or cannot tolerate the associated adverse effects with stimulants. Such difficulties highlight the need for alternative safe and effective medications in the treatment of this disorder. This open-label study assessed the effectiveness of reboxetine, a selective norepinephrine reuptake inhibitor, in children and adolescents with attention deficit hyperactivity disorder (ADHD."nMethods: Fifteen child and adolescent outpatients, aged 7 to 16 (Mean± SD=9.72±2.71 years, diagnosed with ADHD were enrolled in a six open-label study with reboxetine 4-6 mg/d. The principal measure of the outcome was the teacher and parent Attention Deficit Hyperactive Disorder Rating Scale (ADHD Rating Scale. Patients were assessed by a child psychiatrist at baseline, 2, 4 and 6 weeks of the medication started. Side effects questionnaire was used to detect side effects of reboxetine. Repeated measures Analysis of variance (ANOVA was done for comparison of Teacher and Parent ADHD Rating Scale scores during the intervention."nResults: Twelve of 15 (80% participants completed the treatment protocol. A significant decrease in ADHD symptoms on teacher (p=0.04 and parent (p=0.003 ADHD rating scale was noted. Adverse effects were mild to moderate in severity. The most common adverse effects were drowsiness/sedation and appetite decrease."nConclusion: The results of the current study suggest the effectiveness of reboxetine in the treatment of ADHD in children and adolescents. Double-blind, placebo-controlled studies and larger sample size with long duration of intervention are indicated to rigorously

  5. Armodafinil for fatigue associated with menopause: an open-label trial.

    Science.gov (United States)

    Meyer, Fremonta; Freeman, Marlene P; Petrillo, Laura; Barsky, Maria; Galvan, Thania; Kim, Semmie; Cohen, Lee; Joffe, Hadine

    2016-02-01

    This study aims to obtain preliminary data on the efficacy of armodafinil for improving menopause-related fatigue and quality of life. Women (aged 40-65 y) experiencing menopause-related fatigue received open-label armodafinil therapy (up to 150 mg/d) for 4 weeks. Changes from baseline in Brief Fatigue Inventory score and Menopause-Specific Quality of Life (MENQOL) physical domain score were examined using the Wilcoxon signed rank test. Exploratory analyses examined the effects of armodafinil on hot flashes, overall quality of life, insomnia, depression, anxiety, and perceived cognitive performance. After open-label treatment, participants were randomized to double-blind continuation of armodafinil versus placebo for 2 weeks to examine whether treatment discontinuation would precipitate symptom recurrence. Of 29 eligible participants, 20 women (69.0%) completed the trial. During treatment with armodafinil (mean dose, 120 mg/d), median Brief Fatigue Inventory scores decreased by 57.7% from 5.2 (interquartile range [IQR], 4.6-6.2) to 2.2 (IQR, 1.1-4.4; P = 0.0002), and median MENQOL physical domain scores decreased by 51.3% from 3.9 (IQR, 2.3-4.8) to 1.9 (IQR, 1.3-2.7; P = 0.0001). Median hot flashes for 24 hours decreased by 48.3% from 2.9 (IQR, 1.1-4.6) to 1.5 (IQR, 0.4-2.4; P = 0.0005). Improvements in MENQOL total score (49%; P = 0.0001), cognitive function (59.2%; P = 0.0002), depressive symptoms (64.7%; P = 0.0006), insomnia (72.7%; P = 0.0012), and excessive sleepiness (57.1%; P = 0.0006) were noted. Randomized continuation (n = 10) or discontinuation (n = 10) did not indicate group differences. Armodafinil was well-tolerated; three women (12%) were withdrawn for adverse events. These preliminary results suggest a therapeutic effect of armodafinil on fatigue affecting quality of life during menopause, and a potential benefit for other menopause-related symptoms.

  6. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results.

    Science.gov (United States)

    Wang, Michael L; Blum, Kristie A; Martin, Peter; Goy, Andre; Auer, Rebecca; Kahl, Brad S; Jurczak, Wojciech; Advani, Ranjana H; Romaguera, Jorge E; Williams, Michael E; Barrientos, Jacqueline C; Chmielowska, Ewa; Radford, John; Stilgenbauer, Stephan; Dreyling, Martin; Jedrzejczak, Wieslaw Wiktor; Johnson, Peter; Spurgeon, Stephen E; Zhang, Liang; Baher, Linda; Cheng, Mei; Lee, Dana; Beaupre, Darrin M; Rule, Simon

    2015-08-06

    Ibrutinib, an oral inhibitor of Bruton tyrosine kinase, is approved for patients with mantle cell lymphoma (MCL) who have received one prior therapy. We report the updated safety and efficacy results from the multicenter, open-label phase 2 registration trial of ibrutinib (median 26.7-month follow-up). Patients (N = 111) received oral ibrutinib 560 mg once daily, and those with stable disease or better could enter a long-term extension study. The primary end point was overall response rate (ORR). The median patient age was 68 years (range, 40-84), with a median of 3 prior therapies (range, 1-5). The median treatment duration was 8.3 months; 46% of patients were treated for >12 months, and 22% were treated for ≥2 years. The ORR was 67% (23% complete response), with a median duration of response of 17.5 months. The 24-month progression-free survival and overall survival rates were 31% (95% confidence interval [CI], 22.3-40.4) and 47% (95% CI, 37.1-56.9), respectively. The most common adverse events (AEs) in >30% of patients included diarrhea (54%), fatigue (50%), nausea (33%), and dyspnea (32%). The most frequent grade ≥3 infections included pneumonia (8%), urinary tract infection (4%), and cellulitis (3%). Grade ≥3 bleeding events in ≥2% of patients were hematuria (2%) and subdural hematoma (2%). Common all-grade hematologic AEs were thrombocytopenia (22%), neutropenia (19%), and anemia (18%). The prevalence of infection, diarrhea, and bleeding was highest for the first 6 months of therapy and less thereafter. With longer follow-up, ibrutinib continues to demonstrate durable responses and favorable safety in relapsed/refractory MCL. The trial is registered to www.ClinicalTrials.gov as #NCT01236391. © 2015 by The American Society of Hematology.

  7. Progression of Myopic Maculopathy during 18-Year Follow-up.

    Science.gov (United States)

    Fang, Yuxin; Yokoi, Tae; Nagaoka, Natsuko; Shinohara, Kosei; Onishi, Yuka; Ishida, Tomoka; Yoshida, Takeshi; Xu, Xian; Jonas, Jost B; Ohno-Matsui, Kyoko

    2018-06-01

    To examine the progression pattern of myopic maculopathy. Retrospective, observational case series. Highly myopic patients who had been followed up for 10 years or more. Using fundus photographs, myopic features were differentiated according to Meta-analysis of Pathologic Myopia (META-PM) Study Group recommendations. Progression pattern of maculopathy. The study included 810 eyes of 432 patients (mean age, 42.3±16.8 years; mean axial length, 28.8±1.9 mm; mean follow-up, 18.7±7.1 years). The progression rate of myopic maculopathy was 47.0 per 1000 eye-years. Within the pathologic myopia (PM) group (n = 521 eyes), progression of myopic maculopathy was associated with female gender (odds ratio [OR], 2.21; P = 0.001), older age (OR, 1.03; P = 0.002), longer axial length (OR, 1.20; P = 0.007), greater axial elongation (OR, 1.45; P = 0.005), and development of parapapillary atrophy (PPA; OR, 3.14; P < 0.001). Diffuse atrophy, found in 217 eyes without choroidal neovascularization (CNV) or lacquer cracks (LCs) at baseline, progressed in 111 (51%) eyes, leading to macular diffuse atrophy (n = 64; 64/111 or 58%), patchy atrophy (n = 59; 53%), myopic CNV (n = 18; 16%), LCs (n = 9; 5%), and patchy-related macular atrophy (n = 3; 3%). Patchy atrophy, detected in 63 eyes without CNV or LCs at baseline, showed progression in 60 eyes (95%), leading to enlargement of original patchy atrophy (n = 59; 59/60 or 98%), new patchy atrophy (n = 29; 48%), CNV-related macular atrophy (n = 13; 22%), and patchy-related macular atrophy (n = 5; 8%). Of 66 eyes with LCs, 43 eyes (65%) showed progression with development of new patchy atrophy (n = 38; 38/43 or 88%) and new LCs (n = 7; 16%). Reduction in best-corrected visual acuity (BCVA) was associated mainly (all P < 0.001) with the development of CNV or CNV-related macular atrophy and enlargement of macular atrophy. The most frequent progression patterns were an extension of peripapillary diffuse atrophy to macular diffuse

  8. Diagnosis, surgical treatment and follow-up of thyroid cancers

    International Nuclear Information System (INIS)

    Pacini, F.; Pinchera, A.; Vorontsova, T.; Demidchik, E.P.; Delange, F.; Reiners, C.; Schlumberger, M.

    1996-01-01

    This paper reports the activities and the results of the research carried out by the Centers participating to the JSP4 project, within the framework of the EU program on the consequences of the Chernobyl disaster. The project was aimed to develop and to control the application of basic principles for the diagnosis, treatment and follow-up of thyroid carcinoma, with special attention to the peculiar requirement of children and adolescents. To this purpose, training in Western European Centers was offered to a number of scientists from Belarus, Ukraine and Russia. Several official meetings were organized to share views and to discuss the progress of the project. A basic protocol for the diagnosis, treatment and follow-up of thyroid carcinoma has been developed and approved by all participating Centers. Hopefully, it will be applied to the new cases and to those already under monitoring. A large part of the protocol is dedicated to the post-surgical treatment with thyroid hormones for the suppression of TSH and with calcitriol for the management of surgical hypoparathyroidism. A detailed protocol to asses iodine deficiency and, eventually, to introduce a program of iodine supplementation has been proposed. The collection of control cases of childhood thyroid carcinoma in non-radiation exposed European countries has been initiated in Italy, France and Germany. This data will be used as control for the post-Chernobyl childhood thyroid carcinomas. Here is reported a preliminary comparison of the clinical and epidemiological features of almost all (n=368) radiation-exposed Belarus children who developed thyroid carcinoma (age at diagnosis < 16 years), with respect to 90 children of the same age group, who, in the past 20 years, have received treatment for thyroid carcinoma in two centers in Italy (Pisa and Rome). Finally, by molecular biology, genetic mutations of the RET proto-oncogene have been found in several samples of thyroid carcinomas provided by the Belarus

  9. Operative correction and follow-up of craniofacial duplication.

    Science.gov (United States)

    Kotrikova, Bibiana; Hassfeld, Stefan; Steiner, Hans H; Hähnel, Stefan; Krempien, Robert; Mühling, Joachim

    2007-03-01

    Anterior craniofacial duplication (diprosopus) is an extremely rare form of conjoined twins. The children share a single trunk with normal extremities and varying degrees of facial malformation. Duplication of specific structures, such as the nose (diprosopus dirrhinus), eyes (diprosopus tetraophthalmus), and ears, is possible. The authors present a case of partial facial duplication (diprosopus dirrhinus) in a male infant. The clinical and radiographic findings and the surgical correction and follow-up are described. In a single surgical session, the authors were able to achieve not only a functionally but also an aesthetically acceptable result. In the postoperative course, the child showed nearly normal growth and satisfactory psychosocial and motor development. However, 40 months postoperatively, we noticed a tendency of the orbitae to diverge (i.e., toward hypertelorism). The surgical management of complex craniofacial malformations such as diprosopus needs a precise morphologic analysis of the patient's deformity followed by a clear treatment plan. A staged reconstructive approach is carried out to coincide with facial growth patterns and brain and eye function. If the interorbital distance in our patient increases progressively, a second operation for reduction of the interorbital distance may be necessary.

  10. [Assessment and follow up of diabetic patients in hemodialysis].

    Science.gov (United States)

    Sanhueza, María Eugenia; Cotera, Alejandro; Elgueta, Leticia; López S, Gloria; Loncon, Patricia; Macan, Fernando; Pérez, Francisco; Cavada, Gabriel; Alvo, Miriam

    2008-03-01

    Despite a better management of the variables that influence the development of diabetic nephropathy there is a progressive increase in the prevalence of terminal renal failure among diabetics, whose cause is not clear. To study in a group of patients in hemodialysis, the quality of diabetes control previous to the entry to dialysis, their physical condition and their evolution. Diabetic patients with at least three months of hemodialysis answered a questionnaire about diabetes control quality previous to dialysis and had physical and laboratory assessment. They were followed for at least four years thereafter. Fifty seven patients aged 62+/-11 years were studied. Eighty four percent had some degree of disability. Eighty seven percent had high blood pressure and 73% had to enter dialysis as an emergency. Mean glycosilated hemoglobin was 7.7% and 58% had a dialysis dose with a Kt/Vofless than 1.2. Fifty eight percent died during follow up. No relationship between mortality and age, blood pressure, glycosilated hemoglobin of Kt/V, was observed. There is an inadequate management of blood glucose and blood pressure of diabetic patients before entry to dialysis. They are referred inverted exclamation markate to the nephrologist, the dialysis dose is insufficient and they have a high mortality.

  11. SDSS-III MARVELS Planet Candidate RV Follow-up

    Science.gov (United States)

    Ge, Jian; Thomas, Neil; Ma, Bo; Li, Rui; SIthajan, Sirinrat

    2014-02-01

    Planetary systems, discovered by the radial velocity (RV) surveys, reveal strong correlations between the planet frequency and stellar properties, such as metallicity and mass, and a greater diversity in planets than found in the solar system. However, due to the sample sizes of extant surveys (~100 to a few hundreds of stars) and their heterogeneity, many key questions remained to be addressed: Do metal poor stars obey the same trends for planet occurrence as metal rich stars? What is the distribution of giant planets around intermediate- mass stars and binaries? Is the ``planet desert'' within 0.6 AU in the planet orbital distribution of intermediate-mass stars real? The MARVELS survey has produced the largest homogeneous RV measurements of 3300 V=7.6-12 FGK stars. The latest data pipeline effort at UF has been able to remove long term systematic errors suffered in the earlier data pipeline. 18 high confident giant planet candidates have been identified among newly processed data. We propose to follow up these giant planet candidates with the KPNO EXPERT instrument to confirm the detection and also characterize their orbits. The confirmed planets will be used to measure occurrence rates, distributions and multiplicity of giants planets around F,G,K stars with a broad range of mass (~0.6-2.5 M_⊙) and metallicity ([Fe/H]~-1.5-0.5). The well defined MARVELS survey cadence allows robust determinations of completeness limits for rigorously testing giant planet formation theories and constraining models.

  12. Bilateral sacrospinous fixation without hysterectomy: 18-month follow-up

    Science.gov (United States)

    Şentürk, Mehmet Baki; Güraslan, Hakan; Çakmak, Yusuf; Ekin, Murat

    2015-01-01

    Objective The aim of this study was to evaluate the results of bilateral sacrospinous fixation (SSF), which was performed with surgical mesh interposition and bilateral vaginal repair. Material and Methods Twenty-two patients underwent SSF between 2010 and 2012, and the results were evaluated retrospectively. The results at preoperative and postoperative 6th, 12th, and 18th months of the pelvic organ prolapse quantification system (POP-Q) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) were compared using Friedman and Wilcoxon Signed Ranks tests. Values of p<0.05 and <0.01 were considered statistically significant. Results According to the POP-Q, significant healing was observed on all vaginal vault points (p=0.001), and no prolapse was observed until the 18-month follow-up stage. There were also prominent patients who felt satisfactory with respect to their sexual life according to PISQ-12 (p=0.001). Conclusion This technique appears to provide an adequate clinical resolution, and it may be the primary surgical option for women with pelvic organ prolapse. PMID:26097393

  13. Long term follow up in hemodialysis patients with parathyroidectomy

    International Nuclear Information System (INIS)

    Alvarez, A.; Petraglia, A.; Caorsi, H.; Mazzuchi, N.; Olaizola, I.; Acuna, G.; Fajardo, L.; Ambrosoni, P.; Morelli, R.

    1998-01-01

    A retrospective study was performed in 41 patients, in chronic hemodialysis with severe hyperparathyroidism (HPT), who underwent surgery during time period from 1985 to 1997. 22 females, 19 males, aged 50 and 14 years, with PTHI 1345 and 604 pg/ml were followed up 32 and 22 months. Three surgical methods we evaluated: group I) total para thyroidectomy(PTX) with Implants(n=24); group II) subtotal PTX(n=14) and group III) total PTX(n=3). It considered recurrence of HPT when PTH levels were higher than upper range of normal, after 6 months post surgery. persistence was defined when there was no standardization of PTH levels. In group I, 9 patients had normal parathyroid function, 7 had persistent hypoparathyroidism and had hyperparathyroidism (7 recurrences). Group II patients had parathyroid over function in 5 cases (4 persistence s), 5 were normal and 4 hypoparathyroidism. All patients of the third group had hypoparathyroidism. Long term normalization of parathyroid gland activity was achieved in one third of troduccion patients (34,1%) whereas 34,1% permanent hypoparathyroidism and 31,8% hyperparathyroidism. It found no differences in recurrence and histological subtype of parathyroid gland in the different groups. In conclusion, similar long term clinical results were obtained with the different groups. The surgical ideal treatment is controversial. We think that in the long run, the evolution of parathyroid status is mostly influenced by the persistence of uremic state rather than the type of surgery performed [es

  14. Congenital cytomegalovirus infection: treatment, sequelae and follow-up.

    Science.gov (United States)

    Lombardi, Giuseppina; Garofoli, Francesca; Stronati, Mauro

    2010-10-01

    Cytomegalovirus (CMV) is the most common cause of congenital infection affecting about 1% of all the live births worldwide. Its prevalence in the developed world seems to be slightly lower, ranging between 0.6 and 0.7%. Symptoms can be detected at birth in 10-15% of the congenitally infected of which 50-90% will develop sequelae, the most frequent being sensorineural hearing loss (SNHL), visual defect, psychomotor impairment, mental retardation, cerebral palsy and seizures. Eighty-five to 90% of the infected newborns are asymptomatic but 10-15% of them are equally at risk for sensorineural sequelae, like 20-30% of all the infected children. Therefore it is important a time prolonged and closer follow-up of infected children that we propose should be until 6 years of age. This should lead to an early intervention, better management and eventually even control the long-term sequelae. Infants born with symptomatic congenital infection have a worse prognosis than those with no evidence of clinical disease, and ganciclovir (GCV) intravenous 6 mg/kg every 12 h for 6 weeks is the most used therapy for symptomatic newborns. Valganciclovir (V-GCV) syrup is a pro-drug of GCV and presents high oral bioavailability. To date, it is possible to administer this drug at home, and the tolerability profile may allow for wider indications and longer treatments.

  15. Patients’ follow-up using biomechanical analysis of rehabilitation exercises

    Directory of Open Access Journals (Sweden)

    Bruno Bonnechère

    2017-03-01

    Full Text Available Thanks to the evolution of game controllers video games are becoming more and more popular in physical rehabilitation. The integration of serious games in rehabilitation has been tested for various pathologies. Parallel to this clinical research, a lot of studies have been done in order to validate the use of these game controllers for simple biomechanical evaluation. Currently, it is thus possible to record the motions performed by the patients during serious gaming exercises for later analysis. Therefore, data collected during the exercises could be used for monitoring the evolution of the patients during long term rehabilitation. Before using the parameters extracted from the games to assess patients’ evolution two important aspects must be verified: the reproducibility of measurement and a possible effect of learning of the task to be performed. Ten healthy adults played 9 sessions of specific games developed for rehabilitation over a 3-weeks period. Nineteen healthy children played 2 sessions to study the influence of age. Different parameters were extracted from the games: time, range of motion, reaching area. Results of this study indicates that it is possible to follow the evolution of the patients during the rehabilitation process. The majority of the learning effect occurred during the very first session. Therefore, in order to allow proper regular monitoring, the results of this first session should not be included in the follow-up of the patient.

  16. Bradykinesia in Huntington's disease. A prospective, follow-up study.

    Science.gov (United States)

    García Ruiz, Pedro J; Hernández, Jaime; Cantarero, Susana; Bartolomé, Manuel; Sánchez Bernardos, Vicenta; García de Yébenez, Justo

    2002-04-01

    Bradykinesia is a frequent finding in Huntington's disease (HD), but some aspects are presently unknown; including the natural evolution of bradykinesia over time and the correlation between bradykinesia and functional capacity. We studied the motor performance of 20 genetically confirmed patients with HD (age: 40+/-10.8 years; age at onset 33.6+/-11 years; total functional capacity (TFC): 9.57+/-3; UHDRS total motor scale: 31.4+/-13, triplet length (CAG)n: 46.7+/-4 triplets). These patients were studied in baseline conditions and after 18.7+/-6 months of follow-up. In addition, HD patients were compared with 20 age-matched normal controls. Motor study included the four CAPIT timed tests commonly used for Parkinson's disease: pronation-supination (PS), finger dexterity (FD), movement between two points (MTP) and walking test (WT). HD patients were significantly slower than controls in all motor tasks. A significant deterioration occurred over time in three of the four motor tasks (especially FD and WT). A significant correlation between timed tests and TFC score was found (for MTP, r: -0.845; p < 0,0001). In addition a significant correlation between timed tests and the UHDRDS total motor scale was also found (for MTP, r: 0.864; p < 0.0001). In conclusion, simple timed motor tests can detect a deterioration of motor activity over time in HD. Timed tests might be useful to follow the natural evolution of HD and to assess the efficacy of new therapies.

  17. Measles vaccine: a 27-year follow-up.

    LENUS (Irish Health Repository)

    Ramsay, M E

    1994-04-01

    In 1964, the Medical Research Council undertook a trial of measles vaccine in over 36,000 United Kingdom children; 9577 of whom received live vaccine, 10,625 received inactivated followed by live vaccines, and 16,328 acted as unvaccinated controls. Participants in this study have been followed to determine the long term protection from measles vaccine and follow-up data were available on 4194, 4638 and 274 respectively. During the 5-year period 1986-90, the protective efficacy of live measles vaccine has remained high at 87%, but the 95% confidence interval was wide (-43 to 99%) due to the small numbers of cases. Between 1976 and 1990, however, the overall efficacy of the live vaccine was 92% (95% confidence interval 86 to 95%) and there was no evidence of a decline in efficacy (P = 0.13) over the 15-year period. This study suggests that the protection from live measles vaccine persists for up to 27 years after vaccination, and that no change in the current United Kingdom measles immunization policy should be made on the grounds of waning immunity.

  18. Follow-up Sonography after Sonoguided Renal Biopsy

    International Nuclear Information System (INIS)

    Kim, Hyung Soo; Park, Cheol Min; Cha, In Ho

    1996-01-01

    To assess ultrasonographic findings and clinical significance after renal biopsy. 174 cases of post-biopsy sonography were studied retrospectively. We classified post-biopsy hematoma on the basis of their size as small (thickness less than 1 cm, length less than 3cm), medium (thickness less than 1cm, length greater than 3 cm), large (thickness greater than 1 cm, length greater than 3 cm). We also compared bleeding parameters (prothrombin time, partial thromboplastin time) and renal function in both cases which had hematoma or not. Total 33 hematomas were found (19%). Small hematoma was observed in 14 cases, medium hematoma in 16 cases, large hematoma in 3 cases. Severe complications requiring prompt therapy occurred in 1 case(0.6%). In 6 cases hematocrit fell by more than 4%, all of these hematomas were observed on US. Severe complications after sonoguided renal biopsy were rare. There was poor correlation between prebiopsybleeding parameter, renal function and post-biopsy hematomas. And sonography is considered as adequate method for follow up of post-biopsy hematoma

  19. Follow-up study on energy entrepreneurs; Laempoeyrittaejaet seurannassa

    Energy Technology Data Exchange (ETDEWEB)

    Solmio, H

    1995-11-01

    Energy supplying (i.e. wood and peat fuels) is a new form of entrepreneurship in which one or more entrepreneurs attend to the supply of energy to local buildings. At present there are about ten localities where this is practised. TTS Institute is engaged in a follow-up study of a chipfired heating system with energy entrepreneurs supplying the chipped wood. The study is part of the nationwide Bioenergy research programme. The targets of the study, three in number during the 1993-94 heating season, are rural schools located in southern and eastern Finland. The primary fuel used to heat these premises is chipped wood made from small-diameter timber with light fuel oil as the supplementary fuel. The entrepreneurs supplying the chip fuel are local farmers, and they both delivered the fuel and attended to the actual heating. The time consumed in transporting the chipped wood to the heating plant and to attend to the actual heating was 0,1-1,1 h/MWh with the work associated with heating representing 0,2-0,5 h/MWh. The productivity of fuelwood harvesting in the study sites was 0,4-0,8 m{sup 3}/h and the productivity of chipping was 3,8-7,5 loose m{sup 3}/h. TTS Institute expanded the study in 1994 to also include a few premises larger in their energy requirement than those mentioned in the above

  20. Spectroscopic follow-up of the Hercules-Aquila Cloud

    Science.gov (United States)

    Simion, Iulia T.; Belokurov, Vasily; Koposov, Sergey E.; Sheffield, Allyson; Johnston, Kathryn V.

    2018-05-01

    We designed a follow-up program to find the spectroscopic properties of the Hercules-Aquila Cloud (HAC) and test scenarios for its formation. We measured the radial velocities (RVs) of 45 RR Lyrae in the southern portion of the HAC using the facilities at the MDM observatory, producing the first large sample of velocities in the HAC. We found a double-peaked distribution in RVs, skewed slightly to negative velocities. We compared both the morphology of HAC projected on to the plane of the sky and the distribution of velocities in this structure outlined by RR Lyrae and other tracer populations at different distances to N-body simulations. We found that the behaviour is characteristic of an old, well-mixed accretion event with small apo-galactic radius. We cannot yet rule out other formation mechanisms for the HAC. However, if our interpretation is correct, HAC represents just a small portion of a much larger debris structure spread throughout the inner Galaxy whose distinct kinematic structure should be apparent in RV studies along many lines of sight.

  1. Thyroid carcinoma: A follow-up study of 11 years

    International Nuclear Information System (INIS)

    Ritzl, F.; Siebers, G.; Neumann, C.; Ritzl, E.K.

    1987-01-01

    During a follow-up of 11 years of thyroid carcinoma 136 patients were repeatedly examined. 43% papillary, 43% follicular, 11% anaplastic and 2% medullary carcinomas was found. The incidence of these types of carcinoma differed considerably; the frequency peak of papillary carcinomas was reached in 45-year-old humans, that of the follicular carcinomas in people aged 60, that of the anaplastic carcinomas in 70-year-old humans. 84% of the patients was female. Classification in pTNM-system: 8% in pT1, 27% in pT2, 12% in pT3 and 49% in pT4. Local and distant metastases were found at a low rate equally in pT1, pT2 and pT3; 26% of patients in pT4 had local metastases and 18% had distant ones in addition. There were 6 patients with metastases of a differentiated adenocarcinoma accumulating no 131-iodine and with no thyroglobulin in serum. 29% of patients had after thyroidectomy an unilateral paresis of the nervus recurrens and 4% a bilateral one. 26% of patients had a permanent hypoparathyroidism after thyroidectomy. (orig.)

  2. Thyroid carcinoma: A follow-up study of 11 years

    Energy Technology Data Exchange (ETDEWEB)

    Ritzl, F.; Siebers, G.; Neumann, C.; Ritzl, E.K.

    1987-09-01

    During a follow-up of 11 years of thyroid carcinoma 136 patients were repeatedly examined. 43% papillary, 43% follicular, 11% anaplastic and 2% medullary carcinomas was found. The incidence of these types of carcinoma differed considerably; the frequency peak of papillary carcinomas was reached in 45-year-old humans, that of the follicular carcinomas in people aged 60, that of the anaplastic carcinomas in 70-year-old humans. 84% of the patients was female. Classification in pTNM-system: 8% in pT1, 27% in pT2, 12% in pT3 and 49% in pT4. Local and distant metastases were found at a low rate equally in pT1, pT2 and pT3; 26% of patients in pT4 had local metastases and 18% had distant ones in addition. There were 6 patients with metastases of a differentiated adenocarcinoma accumulating no 131-iodine and with no thyroglobulin in serum. 29% of patients had after thyroidectomy an unilateral paresis of the nervus recurrens and 4% a bilateral one. 26% of patients had a permanent hypoparathyroidism after thyroidectomy.

  3. WFIRST Microlensing Exoplanet Characterization with HST Follow up

    Science.gov (United States)

    Bhattacharya, Aparna; David Bennett, Jay Anderson, J.P. Beaulieu.

    2018-01-01

    More than 50 planets are discovered with the different ground based telescopes available for microlensing. But the analysis of ground based data fails to provide a complete solution. To fulfill that gap, space based telescopes, like Hubble space telescope and Spitzer are used. My research work focuses on extracting the planet mass, host star mass, their separation and their distance in physical units from HST Follow-up observations. I will present the challenges faced in developing this method.This is the primary method to be used for NASA's top priority project (according to 2010 decadal survey) Wide Field InfraRed Survey Telescope (WFIRST) Exoplanet microlensing space observatory, to be launched in 2025. The unique ability of microlensing is that with WFIRST it can detect sub-earth- mass planets beyond the reach of Kepler at separation 1 AU to infinity. This will provide us the necessary statistics to study the formation and evolution of planetary systems. This will also provide us with necessary initial conditions to model the formation of planets and the habitable zones around M dwarf stars.

  4. Two Siblings Followed Up for Hereditary Multiple Exostoses

    Directory of Open Access Journals (Sweden)

    Meltem Erol

    2014-06-01

    Full Text Available Hereditary multiple exostoses is an autosomal dominant disease with abnormal bone formation especially at the long bones. Osteochondromas, which occur in the course of the disease, can cause growth disturbances in affected children. Due to pressure effects of osteochondromas, compression of vessels, nerves and tendons, restriction of joint motion, and neurologic compromise as well as painful local symptoms can be seen. Here, we aimed to present two siblings who had generalized pain and swelling in different parts of the body. We detected multiple osteochondromas in different parts of their bodies, especially at the long bones. Our patients had painful local symptoms. There was no growth retardation, but the presence of many osteochondromas led us to contemplate that it was serious form of the disease. Their father had lesser number of osteochondromas. In this paper, we aimed to emphasize the necessity of close follow-up for the risk of malignant transformation of osteochondromas. (The Me­di­cal Bul­le­tin of Ha­se­ki 2014; 52: 116-9

  5. Follow-up measles campaign in the Dominican Republic.

    Science.gov (United States)

    1998-12-01

    The Dominican Republic conducted a national follow-up measles vaccination campaign 6 weeks after sustaining heavy damage from Hurricane Georges, on November 6-12, targeting 830,517 children aged 9 months to 5 years in 29 provinces and the capital city. This campaign was the first mass vaccination effort in the country, following the beginning of the decentralized delivery of health services. Priority was given to vaccinating against diphtheria, whooping cough, and tetanus, especially in refugee camps. More than 500,000 vaccines were given to different age groups, with almost 100,000 of those immunized under 5 years old. Children aged 9 months to 5 years were targeted for immunization regardless of their vaccination status. At the same time, children aged 2 months through 2 years were immunized against poliomyelitis. Vaccination activities were continued until the entire target population was reached and no important side effects have thus far been reported. The government of Mexico donated 300,000 doses of measles vaccine, while other vaccines for the campaign were acquired through the PAHO Revolving Fund for Vaccine Procurement. The decentralized implementation of this campaign allowed the population to actively participate and the resulting high vaccination coverage rates.

  6. Follow-up of obstructive sleep apnea in children.

    Science.gov (United States)

    Barros, Emília Leite de; Pradella-Hallinan, Marcia; Moreira, Gustavo Antonio; Stefanini, Daniele de Oliveira Soares; Tufik, Sergio; Fujita, Reginaldo Raimundo

    2014-01-01

    the evolution of snoring and OSAS in children is not well established since few studies of patients without surgical treatment have been published. to evaluate the evolution of sleep disordered breathing in children who had not been submitted to upper airway surgery. twenty-six children with snoring who had not undergone upper airway surgery were evaluated prospectively. Patients were evaluated by full physical examination and nocturnal polysomnography, after which they were divided into 2 groups: apnea (16 children) and snoring (10 children). After 6 months following the initial evaluation, patients were submitted to a new nocturnal polysomnography, and all data were compared to those of the first examination. the groups did not show any differences regarding age, weight, height and airway physical examination. After 6 months of follow-up, the apnea index did not change, but the respiratory disturbance index increased in the snoring group and the number of hypopneas decreased in the group apnea. there was an increase in the percentage of N1 sleep stage and the respiratory disturbance index in the patients with primary snore. The AHI did not show significant alteration in both groups, but the number of hypopneas decreased in patients with SAOS. Copyright © 2014 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  7. Follow-up of obstructive sleep apnea in children

    Directory of Open Access Journals (Sweden)

    Emília Leite de Barros

    2014-07-01

    Full Text Available INTRODUCTION: the evolution of snoring and OSAS in children is not well established since few studies of patients without surgical treatment have been published. OBJECTIVE: to evaluate the evolution of sleep disordered breathing in children who had not been submitted to upper airway surgery. METHOD: twenty-six children with snoring who had not undergone upper airway surgery were evaluated prospectively. Patients were evaluated by full physical examination and nocturnal polysomnography, after which they were divided into 2 groups: apnea (16 children and snoring (10 children. After 6 months following the initial evaluation, patients were submitted to a new nocturnal polysomnography, and all data were compared to those of the first examination. RESULTS: the groups did not show any differences regarding age, weight, height and airway physical examination. After 6 months of follow-up, the apnea index did not change, but the respiratory disturbance index increased in the snoring group and the number of hypopneas decreased in the group apnea. CONCLUSION: there was an increase in the percentage of N1 sleep stage and the respiratory disturbance index in the patients with primary snore. The AHI did not show significant alteration in both groups, but the number of hypopneas decreased in patients with SAOS.

  8. Thoracic aortic coarctation: MR evaluation and follow-up

    International Nuclear Information System (INIS)

    Papavero, R.; Kastler, B.; Clair, C.; Livolsi, A.; Papavero, R.; Site, O.; Kastler, B.; Clair, C.; Litzler, J.F.; Delabrousse, E.; Scheneider, P.; Bernard, Y.

    2001-01-01

    Purpose: Report our experience in the evaluation and follow-up of thoracic aortic coarctation with MRI and describe its role to estimate trans-stenotic flow. Material and methods: 43 MR examinations were performed in 30 patients (age range 15 days to 73 years) referred to our institution in the last 7 years. Results: MRI visualized the ascending, horizontal and descending portions of the aorta and the supra-aortic vessels in 42/43 patients. MRI clearly identified preoperatively an aortic coarctation in 11/12 cases confirmed by surgery. Postoperatively MRI depicted 4 restenosis and one aneurysm. In 5 patients MRI demonstrated pseudo-coarctation. A significant correlation was established between the maximal trans-stenotic pressure gradient when measured by Doppler US or angiography and the size of the signal void measured on cine-MR images (r=0.72; p<0.01). Conclusion: MRI is a reliable non invasive investigation method for the diagnosis and semi-quantitative evaluation of aortic coarctation particularly when colour Doppler US is not satisfactory. (authors)

  9. Topical Ketamine 10% for Neuropathic Pain in Spinal Cord Injury Patients: An Open-Label Trial.

    Science.gov (United States)

    Rabi, Joseph; Minori, Joshua; Abad, Hasan; Lee, Ray; Gittler, Michelle

    2016-01-01

    Topical ketamine, an N-methyl-D-aspartate antagonist, has been shown to be effective in certain neuropathic pain syndromes. The objective of this study was to determine the efficacy of topical ketamine in spinal cord injury patients with neuropathic pain. An open label trial enrolled five subjects at an outpatient rehabilitation hospital with traumatic spinal cord injuries who had neuropathic pain at or below the level of injury. Subjects applied topical ketamine 10% three times a day for a two-week duration. Subjects recorded their numerical pain score-ranging from 0 to 10, with 0 representing "no pain, 5 representing "moderate pain," and 10 being described as "worst possible pain"-in a journal at the time of application of topical ketamine and one hour after application. Using a numerical pain scale allows for something as subjective as pain to be given an objective quantification. Subjects also recorded any occurrence of adverse events and level of satisfaction. All five subjects had a decrease in their numerical pain scale by the end of two weeks, ranging from 14% to 63%. The duration ranged from one hour in one subject to the next application in other subjects. There were no adverse effects. Overall, four out of the five subjects stated they were satisfied. Topical ketamine 10% is an effective neuropathic pain medicine in patients with spinal cord injuries; however, further studies need to be done with a placebo and larger sample size. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  10. Adjunctive low-dose docosahexaenoic acid (DHA) for major depression: An open-label pilot trial.

    Science.gov (United States)

    Smith, Deidre J; Sarris, Jerome; Dowling, Nathan; O'Connor, Manjula; Ng, Chee H

    2018-04-01

    Whilst the majority of evidence supports the adjunctive use of eicosapentaenoic acid (EPA) in improving mood, to date no study exists using low-dose docosahexaenoic acid (DHA) alone as an adjunctive treatment in patients with mild to moderate major depressive disorder (MDD). A naturalistic 8-week open-label pilot trial of low-dose DHA, (260 mg or 520 mg/day) in 28 patients with MDD who were non-responsive to medication or psychotherapy, with a Hamilton Depression Rating Scale (HAM-D) score of greater than 17, was conducted. Primary outcomes of depression, clinical severity, and daytime sleepiness were measured. After 8 weeks, 54% of patients had a ≥50% reduction on the HAM-D, and 45% were in remission (HAM-D ≤ 7). The eta-squared statistic (0.59) indicated a large effect size for the reduction of depression (equivalent to Cohen's d of 2.4). However confidence in this effect size is tempered due to the lack of a placebo. The mean score for the Clinical Global Impression Severity Scale was significantly improved by 1.28 points (P depression.

  11. Shelf Life of Food Products: From Open Labeling to Real-Time Measurements.

    Science.gov (United States)

    Corradini, Maria G

    2018-03-25

    The labels currently used on food and beverage products only provide consumers with a rough guide to their expected shelf lives because they assume that a product only experiences a limited range of predefined handling and storage conditions. These static labels do not take into consideration conditions that might shorten a product's shelf life (such as temperature abuse), which can lead to problems associated with food safety and waste. Advances in shelf-life estimation have the potential to improve the safety, reliability, and sustainability of the food supply. Selection of appropriate kinetic models and data-analysis techniques is essential to predict shelf life, to account for variability in environmental conditions, and to allow real-time monitoring. Novel analytical tools to determine safety and quality attributes in situ coupled with modern tracking technologies and appropriate predictive tools have the potential to provide accurate estimations of the remaining shelf life of a food product in real time. This review summarizes the necessary steps to attain a transition from open labeling to real-time shelf-life measurements.

  12. Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study.

    Science.gov (United States)

    Goadsby, P J; Grosberg, B M; Mauskop, A; Cady, R; Simmons, K A

    2014-10-01

    We sought to assess a novel, noninvasive, portable vagal nerve stimulator (nVNS) for acute treatment of migraine. Participants with migraine with or without aura were eligible for an open-label, single-arm, multiple-attack study. Up to four migraine attacks were treated with two 90-second doses, at 15-minute intervals delivered to the right cervical branch of the vagus nerve within a six-week time period. Subjects were asked to self-treat at moderate or severe pain, or after 20 minutes of mild pain. Of 30 enrolled patients (25 females, five males, median age 39), two treated no attacks, and one treated aura only, leaving a Full Analysis Set of 27 treating 80 attacks with pain. An adverse event was reported in 13 patients, notably: neck twitching (n = 1), raspy voice (n = 1) and redness at the device site (n = 1). No unanticipated, serious or severe adverse events were reported. The pain-free rate at two hours was four of 19 (21%) for the first treated attack with a moderate or severe headache at baseline. For all moderate or severe attacks at baseline, the pain-free rate was 12/54 (22%). nVNS may be an effective and well-tolerated acute treatment for migraine in certain patients. © International Headache Society 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  13. Open-label pilot study of memantine in the treatment of compulsive buying.

    Science.gov (United States)

    Grant, Jon E; Odlaug, Brian L; Mooney, Marc; O'Brien, Robert; Kim, Suck Won

    2012-05-01

    Although compulsive buying (CB) is relatively common, pharmacotherapy research for CB is limited. Memantine, an N-methyl-D-aspartate receptor antagonist, appears to reduce glutamate excitability and improve impulsive behaviors, suggesting it may help individuals with CB. Nine patients (8 females) with CB were enrolled in a 10-week open-label treatment study of memantine (dose ranging from 10 to 30 mg/d). Participants were enrolled from December 2008 until May 2010. The primary outcome measure was change from baseline to study endpoint on the Yale-Brown Obsessive Compulsive Scale-Shopping Version (Y-BOCS-SV). Of the 9 participants, 8 (88.9%) completed the 10-week study. Y-BOCS-SV scores decreased from a mean of 22.0 ± 1.3 at baseline to 11.0 ± 5.3 at endpoint (P impulsive buying and improvements on cognitive tasks of impulsivity. In addition, the medication was well-tolerated. These findings suggest that pharmacologic manipulation of the glutamate system may target the impulsive behavior underlying CB. Placebo-controlled, double-blind studies are warranted in order to confirm these preliminary findings in a controlled design.

  14. Topical Coconut Oil in Very Preterm Infants: An Open-Label Randomised Controlled Trial.

    Science.gov (United States)

    Strunk, Tobias; Pupala, Sameer; Hibbert, Julie; Doherty, Dorota; Patole, Sanjay

    2018-01-01

    The immature fragile skin of preterm infants represents an inadequate protective barrier. The emollient and anti-infective properties of coconut oil make it a potentially beneficial topical agent for this population. Our aim was to evaluate feasibility, safety, and the effects of topical coconut oil on skin condition in very preterm infants. An open-label randomised controlled trial in preterm infants coconut oil (5 mL/kg) twice daily for 21 days, starting within 24 h of birth. The neonatal skin condition was the primary outcome, and was assessed using the Neonatal Skin Condition Score (NSCS) on days 1, 7, 14, and 21. The number of coconut oil applications was recorded to assess clinical feasibility and all enrolled infants were monitored for adverse effects of topical coconut application, such as skin irritation. A total of 72 infants born coconut oil was feasible and without adverse effects. The NSCS was maintained in the coconut oil group throughout the intervention period, but deteriorated from a median (IQR) of 3 (3-4) on day 1 to 4 (4-4) on day 21 in the control group (p = 0.01). There were no differences in common neonatal outcomes, including sepsis, necrotising enterocolitis, retinopathy of prematurity, chronic lung disease, and mortality. Topical coconut oil maintained a better skin condition in very preterm infants without adverse effects. This simple, safe, and affordable intervention warrants further investigation. © 2017 S. Karger AG, Basel.

  15. Effect of omega-3 polyunsaturated fatty acids on the cytoskeleton: an open-label intervention study.

    Science.gov (United States)

    Schmidt, Simone; Willers, Janina; Riecker, Sabine; Möller, Katharina; Schuchardt, Jan Philipp; Hahn, Andreas

    2015-02-14

    Omega-3 polyunsaturated fatty acids (n-3 PUFAs) show beneficial effects on cardiovascular health and cognitive functions, but the underlying molecular mechanisms are not completely understood. Because of the fact that cytoskeleton dynamics affect almost every cellular process, the regulation of cytoskeletal dynamics could be a new pathway by which n-3 PUFAs exert their effects on cellular level. A 12-week open-label intervention study with 12 healthy men was conducted to determine the effects of 2.7 g/d n-3 PUFA on changes in mRNA expression of cytoskeleton-associated genes by quantitative real-time PCR in whole blood. Furthermore, the actin content in red blood cells was analyzed by immunofluorescence imaging. N-3 PUFA supplementation resulted in a significant down-regulation of cytoskeleton-associated genes, in particular three GTPases (RAC1, RHOA, CDC42), three kinases (ROCK1, PAK2, LIMK), two Wiskott-Aldrich syndrome proteins (WASL, WASF2) as well as actin related protein 2/3 complex (ARPC2, ARPC3) and cofilin (CFL1). Variability in F-actin content between subjects was high; reduced actin content was only reduced within group evaluation. Reduced cytoskeleton-associated gene expression after n-3 PUFA supplementation suggests that regulation of cytoskeleton dynamics might be an additional way by which n-3 PUFAs exert their cellular effects. Concerning F-actin, this analysis did not reveal unmistakable results impeding a generalized conclusion.

  16. An Open-Label Trial of Memantine for Cognitive Impairment in Patients with Posttraumatic Stress Disorder

    Directory of Open Access Journals (Sweden)

    Sriram Ramaswamy

    2015-01-01

    Full Text Available Background. Studies using standard neuropsychological instruments have demonstrated memory deficits in patients with PTSD. We evaluated the efficacy and safety of the N-methyl-D-aspartate antagonist memantine in veterans with PTSD and cognitive impairment. Methods. Twenty-six veterans with PTSD and cognitive impairment received 16 weeks of memantine in an open-label fashion. Cognition was assessed using the Spatial Span, Logical Memory I, and Letter-Number Sequencing subtests of the Wechsler Memory Scale III and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS. RBANS measures attention, language, visuospatial skills, and immediate and delayed memories. The Clinician Administered PTSD Scale (CAPS, Hamilton Depression Scale (HAM-D, Hamilton Anxiety Scale (HAM-A, Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q, and Sheehan Disability Scale (SDS were secondary outcome measures. Results. There was a significant improvement in RBANS, both total and subscale scores (P<0.05, over time. There was a reduction in total CAPS scores, avoidance/numbing symptoms (CAPS-C and hyperarousal symptoms (CAPS-D, HAM-D, Q-LES-Q, and SDS scores. However, there was no reduction in reexperiencing (CAPS-B and HAM-A scores. Memantine was well tolerated. Conclusions. Memantine improved cognitive symptoms, PTSD symptoms, and mood in veterans with PTSD. Randomized double-blind studies are needed to validate these preliminary observations.

  17. Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients

    Science.gov (United States)

    Tedesco-Silva, Helio; Peddi, V. Ram; Sánchez-Fructuoso, Ana; Marder, Brad A.; Russ, Graeme R.; Diekmann, Fritz; Flynn, Alison; Hahn, Carolyn M.; Li, Huihua; Tortorici, Michael A.; Schulman, Seth L.

    2016-01-01

    Background Calcineurin inhibitor–associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients. Methods This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus. The primary end point was percentage of patients with 5 mL/min per 1.73 m2 or greater improvement in estimated glomerular filtration rate from randomization to month 24. Results The on-therapy population included 195 patients (sirolimus, 86; tacrolimus, 109). No between-group difference was noted in percentage of patients with 5 mL/min per 1.73 m2 or greater estimated glomerular filtration rate improvement (sirolimus, 34%; tacrolimus, 42%; P = 0.239) at month 24. Sirolimus patients had higher rates of biopsy-confirmed acute rejection (8% vs 2%; P = 0.02), treatment discontinuation attributed to adverse events (21% vs 3%; P renal function improvement at 24 months is similar for patients with early conversion to sirolimus after kidney transplantation versus those remaining on tacrolimus. PMID:27500260

  18. Self-reported physical activity and lung function two months after cardiac surgery--a prospective cohort study.

    Science.gov (United States)

    Jonsson, Marcus; Urell, Charlotte; Emtner, Margareta; Westerdahl, Elisabeth

    2014-03-28

    Physical activity has well-established positive health-related effects. Sedentary behaviour has been associated with postoperative complications and mortality after cardiac surgery. Patients undergoing cardiac surgery often suffer from impaired lung function postoperatively. The association between physical activity and lung function in cardiac surgery patients has not previously been reported. Patients undergoing cardiac surgery were followed up two months postoperatively. Physical activity was assessed on a four-category scale (sedentary, moderate activity, moderate regular exercise, and regular activity and exercise), modified from the Swedish National Institute of Public Health's national survey. Formal lung function testing was performed preoperatively and two months postoperatively. The sample included 283 patients (82% male). Two months after surgery, the level of physical activity had increased (p < 0.001) in the whole sample. Patients who remained active or increased their level of physical activity had significantly better recovery of lung function than patients who remained sedentary or had decreased their level of activity postoperatively in terms of vital capacity (94 ± 11% of preoperative value vs. 91 ± 9%; p = 0.03), inspiratory capacity (94 ± 14% vs. 88 ± 19%; p = 0.008), and total lung capacity (96 ± 11% vs. 90 ± 11%; p = 0.01). An increased level of physical activity, compared to preoperative level, was reported as early as two months after surgery. Our data shows that there could be a significant association between physical activity and recovery of lung function after cardiac surgery. The relationship between objectively measured physical activity and postoperative pulmonary recovery needs to be further examined to verify these results.

  19. An Open-Label Pilot Study of Combined Augmentation With Creatine Monohydrate and 5-Hydroxytryptophan for Selective Serotonin Reuptake Inhibitor- or Serotonin-Norepinephrine Reuptake Inhibitor-Resistant Depression in Adult Women.

    Science.gov (United States)

    Kious, Brent M; Sabic, Hana; Sung, Young-Hoon; Kondo, Douglas G; Renshaw, Perry

    2017-10-01

    Many women with major depressive disorder (MDD) respond inadequately to standard treatments. Augmentation of conventional antidepressants with creatine monohydrate and 5-hydroxytryptophan (5-HTP) could correct deficits in serotonin production and brain bioenergetics associated with depression in women, yielding synergistic benefit. We describe an open-label study of 5-HTP and creatine augmentation in women with MDD who had failed selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) monotherapy. Fifteen women who were adequately adherent to an SSRI or SNRI and currently experiencing MDD, with a 17-item Hamilton Depression Rating Scale (HAM-D) score of 16 or higher, were treated with 5 g of creatine monohydrate daily and 100 mg of 5-HTP twice daily for 8 weeks, with 4 weeks of posttreatment follow-up. The primary outcome was change in mean HAM-D scores. Mean HAM-D scores declined from 18.9 (SD, 2.5) at pretreatment visits to 7.5 (SD, 4.4) (P creatine and 5-HTP may represent an effective augmentation strategy for women with SSRI- or SNRI-resistant depression. Given the limitations of this small, open-label trial, future study in randomized, placebo-controlled trials is warranted.

  20. Electrochemical sensors in breast cancer diagnostics and follow-up

    Directory of Open Access Journals (Sweden)

    Raquel Marques

    2015-12-01

    electrodes (SPCEs were used as the transducers. These SPCEs (working volume: ~40 μL are widely employed in the construction of electrochemical (biosensors because of several reasons: simplicity and low cost, versatility of design, small dimensions and possibility of incorporation in portable systems, as well as adequate electroanalytical characteristics. These SPCEs were modified with gold nanoparticles (nAu through the electrochemical deposition of ionic gold from a solution. The developed sensors were applied to the analysis of the selected biomarkers in spiked human serum samples.Besides these immunosensors, a molecularly imprinted polymer (MIP sensor was developed for the analysis of HER2-ECD. In this case a gold electrode was used as the transducer. The MIP was formed by surface imprinting and electrochemical impedance spectroscopy and voltammetry were used for detection purposes.Results: For the immunoassays the following parameters were optimized: capture and detection antibody concentration, surface blocking, reaction mixtures and incubation times. The best limits of detection obtained were below the established cut-off values (25 U/mL and 15 ng/mL for CA15-3 and HER2-ECD, respectively. For the MIP sensor the most adequate polymer was chosen and the electropolymerization, template removal, and incubation conditions were optimized. The lowest HER2-ECD concentration that was analyzed was 50 µg/mL.Conclusion: The obtained results indicate that the developed sensors could be promising tools in breast cancer diagnostics and follow-up. However, further studies should be conducted using patients' samples and the results of these assays should be validated with the established analysis procedures for these cancer biomarkers.-----------------------------------------Cite this article as:  Marques R, Pacheco J, Rama EC, Viswanathan S, Nouws H, Delerue-Matos C. Electrochemical sensors in breast cancer diagnostics and follow-up. Int J Cancer Ther Oncol 2015; 3(4:34012.[This

  1. Clinical 3-year follow-up of uterine fibroid embolization

    International Nuclear Information System (INIS)

    Radeleff, B.A.; Satzl, S.; Eiers, M.; Fechtner, K.; Hakim, A.; Kauffmann, G.W.; Richter, G.M.; Rimbach, S.

    2007-01-01

    Purpose: The purpose of this study was to evaluate the clinical long-term success of uterine artery embolization (UAE) in patients with symptomatic fibroids using spherical particles (Embosphere). Materials and Methods: 34 consecutive patients treated with UAE were initially enrolled in the study which had the following study goals (1) 1-year follow-up MRI evaluation of the fibroid behavior and (2) clinical long-term success due to standardized assessment of the main fibroid-related symptoms (hypermenorrhoea, dysmenorrhoea and dysuria) of the patients' individual overall health status and their therapy satisfaction at 1-year, 2- year and 3-year intervals after UAE. Results: Technical success was achieved in all procedures. Four patients had to be excluded from the long-term evaluation schedule: one because of a hysterectomy due to bleeding after 6 weeks, 3 patients were not available for the designated minimum follow-up interval. The preinterventional severe hypermenorrhoea (n = 27) with a score of 4.4 ± 0.7 (5 = extreme menstrual bleeding) decreased after one year to 2.1 ± 0.5 (p = 0.0001), after two years to 1.7 ± 0.5 (p = 0.0042) and after three years to 1.3 ± 0.6 (p = 0.0001). The preinterventional dysmenorrhoea (n = 15) with a score of 3.1 ± 1.5 (3 = distinctly increased dysmenorrhoea) decreased after one year to 1.1 ± 0.3 (p = 0.0001), after two years to 1.2 ± 0.2 and after three years to 1.2 ± 0.4 (p = 0.148). The pretreatment dysuria (n = 12) with a preinterventional score of 3.1 ± 1.5 (3 = distinctly increased dysuria) decreased after one year to 1.1 ± 0.3 (p 0.0069) and remained after two years at 1.1 ± 0.2 and after three years at 1.2 ± 0.4 (p = 0.905). The initial overall health status was 54.7 ± 20.1 (maximal value 100). After one year it rose to 90.5 ± 15.4 (p = 0.0001), was 91.8 ± 5.6 after two years and was 91.3 ± 8.5 (p = 0.8578) after three years. The satisfaction with the therapy was 2.9 ± 0.2 after one year, 2.6 ± 0.3 after two

  2. Postpartum follow-up: can psychosocial support reduce newborn readmissions?

    Science.gov (United States)

    Barilla, Dora; Marshak, Helen Hopp; Anderson, S Eric; Hopp, Joyce W

    2010-01-01

    To determine whether there was a relationship between postpartum psychosocial support from healthcare providers and the rate of normal newborn readmissions (NNRs), and whether there was a cost benefit to justify an intervention. Data were abstracted for all normal newborn births from 1999 to 2006 (N = 14,786) at a community hospital in southern California at three different time periods: (1) at baseline prior to any intervention (1999-2000), (2) the 4 years during the comprehensive psychosocial support intervention (2001-2004), and (3) the 2 years during a limited psychosocial support intervention (2004-2006). A cost-benefit analysis was performed to analyze whether the financial benefits from the intervention matched or exceeded the costs for NNRs. There was a significantly lower readmission rate of 1.0% (p = < .001) during the comprehensive intervention time period compared to baseline (2.3%) or to the limited intervention time period (2.3%). Although there was no significant difference in the average cost per newborn readmitted across the three study time periods, during the comprehensive intervention time period the average costs of a NNR were significantly lower ($4,180, p = .041) for the intervention group compared to those who received no intervention ($5,338). There was a cost benefit of 513,540 dollars due to fewer readmissions during the comprehensive time period, but it did not exceed the cost of the intervention. Providing comprehensive follow-up for new mothers in the postpartum period can reduce NNRs, thus lowering the average newborn readmission costs for those who receive psychosocial support. Followup for new mothers should be an accepted norm rather than the exception in postpartum care, but NNRs should not be considered the sole outcome in such programs.

  3. Parenchymal neurocysticercosis: follow-up and staging by MRI

    International Nuclear Information System (INIS)

    Dumas, J.L.; Visy, J.M.; Belin, C.; Gaston, A.; Goldlust, D.; Dumas, M.

    1997-01-01

    We describe the evolution of parenchymal cerebral cysticerci on MRI, to assess signs of early cyst degeneration. We studied 15 lesions in four treated and one untreated patient. MRI was performed before therapy and repeated in the 1st month after each course of anticysticercus drugs, every 4 months during the 1st year and then annually; the follow-up period was 8-48 months. Lesions were classified according to changes in four features: cyst content and capsule signal, gadolinium enhancement and oedema signal. We were able to recognise each of the pathological phases; five MRI stages were identified. Stage 1 showed oedema and/or nodular gadolinium enhancement in the tissue invasion phase; stage 2 was cerebrospinal fluid-like signal within a cyst in the vesicular phase; stage 3 showed a thick capsule with an impure liquid content signal and surrounding oedema, in the cystic phase; stage 4 showed the disappearance of the cyst fluid content signal in the degenerative phase; stage 5 showed a calcified lesion in the residual phase. Stage 1 lesions disappeared after therapy; the other progressed from one stage to another. Stage 4 indicated the end of viability of the parasite and determined the point after which treatment was useless. On T2-weighted images changes in the cyst content differed according to the history of the lesion; nodular low intensity followed the natural degeneration of the parasite and a mixed fluid signal with punctate low signal seemed to represent the specific result of therapy. MRI staging can help in the evaluation of indications for treatment and facilitate clinical therapeutic trials. (orig.). With 4 figs., 1 tab

  4. PNH revisited: Clinical profile, laboratory diagnosis and follow-up

    Directory of Open Access Journals (Sweden)

    Gupta P

    2009-01-01

    Full Text Available Background: Paroxysmal nocturnal hemoglobinuria (PNH is characterized by intravascular hemolysis, marrow failure, nocturnal hemoglobinuria and thrombophila. This acquired disease caused by a deficiency of glycosylphosphatidylinositol (GPI anchored proteins on the hematopoietic cells is uncommon in the Indian population. Materials and Methods: Data of patients diagnosed with PNH in the past 1 year were collected. Clinical data (age, gender, various presenting symptoms, treatment information and follow-up data were collected from medical records. Results of relevant diagnostic tests were documented i.e., urine analysis, Ham′s test, sucrose lysis test and sephacryl gel card test (GCT for CD55 and CD59. Results: A total of 5 patients were diagnosed with PNH in the past 1 year. Presenting symptoms were hemolytic anemia (n=4 and bone marrow failure (n=1. A GCT detected CD59 deficiency in all erythrocytes in 4 patients and CD55 deficiency in 2 patients. A weak positive PNH test for CD59 was seen in 1 patient and a weak positive PNH test for CD55 was seen in 3 patients. All patients were negative by sucrose lysis test. Ham′s test was positive in two cases. Patients were treated with prednisolone and/or androgen and 1 patient with aplastic anemia was also given antithymocyte globulin. A total of 4 patients responded with a partial recovery of hematopoiesis and 1 patient showed no recovery. None of the patients received a bone marrow transplant. Conclusion: The study highlights the diagnostic methods and treatment protocols undertaken to evaluate the PNH clone in a developing country where advanced methods like flowcytometry immunophenotyping (FCMI and bone marrow transplants are not routinely available.

  5. Tracking the follow-up of work in progress papers.

    Science.gov (United States)

    Mubin, Omar; Arsalan, Mudassar; Al Mahmud, Abdullah

    2018-01-01

    Academic conferences offer numerous submission tracks to support the inclusion of a variety of researchers and topics. Work in progress papers are one such submission type where authors present preliminary results in a poster session. They have recently gained popularity in the area of Human Computer Interaction (HCI) as a relatively easier pathway to attending the conference due to their higher acceptance rate as compared to the main tracks. However, it is not clear if these work in progress papers are further extended or transitioned into more complete and thorough full papers or are simply one-off pieces of research. In order to answer this we explore self-citation patterns of four work in progress editions in two popular HCI conferences (CHI2010, CHI2011, HRI2010 and HRI2011). Our results show that almost 50% of the work in progress papers do not have any self-citations and approximately only half of the self-citations can be considered as true extensions of the original work in progress paper. Specific conferences dominate as the preferred venue where extensions of these work in progress papers are published. Furthermore, the rate of self-citations peaks in the immediate year after publication and gradually tails off. By tracing author publication records, we also delve into possible reasons of work in progress papers not being cited in follow up publications. In conclusion, we speculate on the main trends observed and what they may mean looking ahead for the work in progress track of premier HCI conferences.

  6. Parenchymal neurocysticercosis: follow-up and staging by MRI

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    Dumas, J.L. [Dept. of Radiology, Hopital Avicenne, Bobigny (France)]|[Inst. of Tropical Neurology, Faculty of Medicine, Limoges (France); Visy, J.M. [Dept. of Neurology, Hopital Lariboisiere, Paris (France); Belin, C. [Dept. of Neurology, Hopital Avicenne, Bobigny (France); Gaston, A. [Dept. of Neuroradiology, Hopital Henri-Mondor, Creteil (France); Goldlust, D. [Dept. of Radiology, Hopital Avicenne, Bobigny (France); Dumas, M. [Inst. of Tropical Neurology, Faculty of Medicine, Limoges (France)

    1997-01-01

    We describe the evolution of parenchymal cerebral cysticerci on MRI, to assess signs of early cyst degeneration. We studied 15 lesions in four treated and one untreated patient. MRI was performed before therapy and repeated in the 1st month after each course of anticysticercus drugs, every 4 months during the 1st year and then annually; the follow-up period was 8-48 months. Lesions were classified according to changes in four features: cyst content and capsule signal, gadolinium enhancement and oedema signal. We were able to recognise each of the pathological phases; five MRI stages were identified. Stage 1 showed oedema and/or nodular gadolinium enhancement in the tissue invasion phase; stage 2 was cerebrospinal fluid-like signal within a cyst in the vesicular phase; stage 3 showed a thick capsule with an impure liquid content signal and surrounding oedema, in the cystic phase; stage 4 showed the disappearance of the cyst fluid content signal in the degenerative phase; stage 5 showed a calcified lesion in the residual phase. Stage 1 lesions disappeared after therapy; the other progressed from one stage to another. Stage 4 indicated the end of viability of the parasite and determined the point after which treatment was useless. On T2-weighted images changes in the cyst content differed according to the history of the lesion; nodular low intensity followed the natural degeneration of the parasite and a mixed fluid signal with punctate low signal seemed to represent the specific result of therapy. MRI staging can help in the evaluation of indications for treatment and facilitate clinical therapeutic trials. (orig.). With 4 figs., 1 tab.

  7. [Endoscopic follow-up of translaryngeal Fantoni tracheostomy].

    Science.gov (United States)

    Succo, G; Crosetti, E; Mattalia, P; Voltolina, M; Bramardi, F; Di Lisi, D; Riva, F; Sartoris, A

    2002-08-01

    Dilatational tracheotomy techniques are widely used in the long-term management of the respiratory tract in patients in intensive care units (ICU). The translaryngeal tracheotomy technique (TLT) was first described by Fantoni in 1993 and rapidly asserted itself, especially in Europe. This technique basically differs from the other percutaneous techniques in that it involves a progressive, retrograde, dilatation of the trachea in a single session conducted from inside the trachea, working outward, simultaneously exerting a counter-pressure on the pre-tracheal soft tissues with the fingers. The present study involves an endoscopy follow-up of 130 patients who had undergone TLT at the Intensive Care Unit of our Hospital between November 2000 and May 2001. The pre-operative oro-tracheal intubation time varied from 1 to 42 days. All patients filled out a brief questionnaire containing validated questions on their general health and quality of life with particular attention focused on respiratory conditions. Then, after receiving informed consent, the patients underwent laryngo-tracheoscopy with local anesthetic using a flexible tracheobronchoscope. All tests were recorded and viewed later by two operators in order to identify and divide the patients according to the level of execution of the tracheotomy and the presence of sequelae. The results obtained have shown that, like other percutaneous tracheotomy techniques, TLT provides some benefits including the fact that procedure can be performed at the bedside in a short time, with few post-operative complications, simpler nursing and fewer sequelae in time. Analysis of data concerning time of tracheostomy execution, tracheal level of stomia and nursing times has revealed three factors that determine severe sequelae: delay in tracheostomy execution, high level of execution with cricoid involvement and onset of problems during first tracheal cannula change.

  8. Long-Term, Open-Label Safety and Efficacy of Atomoxetine in Adults with ADHD: Final Report of a 4-Year Study

    Science.gov (United States)

    Adler, Lenard A.; Spencer, Thomas J.; Williams, David W.; Moore, Rodney J.; Michelson, David

    2008-01-01

    Objective: Previously, data from 97 weeks of open-label atomoxetine treatment of adults with attention-deficit/hyperactivity disorder (ADHD) were reported. This final report of that study presents results from over 4 years of treatment. Method: Results were derived from the study of 384 patients (125 patients remaining in the open-label trial…

  9. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study.

    Science.gov (United States)

    Beigel, John H; Tebas, Pablo; Elie-Turenne, Marie-Carmelle; Bajwa, Ednan; Bell, Todd E; Cairns, Charles B; Shoham, Shmuel; Deville, Jaime G; Feucht, Eric; Feinberg, Judith; Luke, Thomas; Raviprakash, Kanakatte; Danko, Janine; O'Neil, Dorothy; Metcalf, Julia A; King, Karen; Burgess, Timothy H; Aga, Evgenia; Lane, H Clifford; Hughes, Michael D; Davey, Richard T

    2017-06-01

    Influenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza. In this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA assessed the safety and efficacy of anti-influenza plasma with haemagglutination inhibition antibody titres of 1:80 or more to the infecting strain. Hospitalised children and adults (including pregnant women) with severe influenza A or B (defined as the presence of hypoxia or tachypnoea) were randomly assigned to receive either two units (or paediatric equivalent) of anti-influenza plasma plus standard care, versus standard care alone, and were followed up for 28 days. The primary endpoint was time to normalisation of patients' respiratory status (respiratory rate of ≤20 breaths per min for adults or age-defined thresholds of 20-38 breaths per min for children) and a room air oxygen saturation of 93% or more. This study is registered with ClinicalTrials.gov, number NCT01052480. Between Jan 13, 2011, and March 2, 2015, 113 participants were screened for eligibility and 98 were randomly assigned from 20 out of 29 participating sites. Of the participants with confirmed influenza (by PCR), 28 (67%) of 42 in the plasma plus standard care group normalised their respiratory status by day 28 compared with 24 (53%) of 45 participants on standard care alone (p=0·069). The hazard ratio (HR) comparing plasma plus standard care with standard care alone was 1·71 (95% CI 0·96-3·06). Six participants died, one (2%) from the plasma plus standard care group and five (10%) from the standard care group (HR 0·19 [95% CI 0·02-1·65], p=0·093). Participants in the plasma plus standard care group had non-significant reductions in days in hospital (median 6 days [IQR 4-16] vs 11 days [5-25], p=0·13) and days on mechanical ventilation (median 0 days [IQR 0-6] vs 3 days

  10. The effects of individual upper alpha neurofeedback in ADHD: an open-label pilot study.

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    Escolano, C; Navarro-Gil, M; Garcia-Campayo, J; Congedo, M; Minguez, J

    2014-12-01

    Standardized neurofeedback (NF) protocols have been extensively evaluated in attention-deficit/hyperactivity disorder (ADHD). However, such protocols do not account for the large EEG heterogeneity in ADHD. Thus, individualized approaches have been suggested to improve the clinical outcome. In this direction, an open-label pilot study was designed to evaluate a NF protocol of relative upper alpha power enhancement in fronto-central sites. Upper alpha band was individually determined using the alpha peak frequency as an anchor point. 20 ADHD children underwent 18 training sessions. Clinical and neurophysiological variables were measured pre- and post-training. EEG was recorded pre- and post-training, and pre- and post-training trials within each session, in both eyes closed resting state and eyes open task-related activity. A power EEG analysis assessed long-term and within-session effects, in the trained parameter and in all the sensors in the (1-30) Hz spectral range. Learning curves over sessions were assessed as well. Parents rated a clinical improvement in children regarding inattention and hyperactivity/impulsivity. Neurophysiological tests showed an improvement in working memory, concentration and impulsivity (decreased number of commission errors in a continuous performance test). Relative and absolute upper alpha power showed long-term enhancement in task-related activity, and a positive learning curve over sessions. The analysis of within-session effects showed a power decrease ("rebound" effect) in task-related activity, with no significant effects during training trials. We conclude that the enhancement of the individual upper alpha power is effective in improving several measures of clinical outcome and cognitive performance in ADHD. This is the first NF study evaluating such a protocol in ADHD. A controlled evaluation seems warranted due to the positive results obtained in the current study.

  11. A Phase Ib open label, randomized, safety study of SANGUINATE™ in patients with sickle cell anemia

    Directory of Open Access Journals (Sweden)

    Hemant Misra

    Full Text Available Abstract Background: Treatment of sickle cell anemia is a challenging task and despite the well understood genetic and biochemical pathway of sickle hemoglobin, current therapy continues to be limited to the symptomatic treatment of pain, supplemental oxygen, antibiotics, red blood cell transfusions and hydroxyurea. SANGUINATE is a carbon monoxide releasing molecule and oxygen transfer agent under clinical development for the treatment of sickle cell anemia and comorbidities. Methods: An open-label randomized Phase Ib study was performed in adult sickle cell anemia patients. Two dose levels of SANGUINATE were compared to hydroxyurea in 24 homozygotes for Hb SS. Twelve subjects received either a low dose (160 mg/kg of SANGUINATE or 15 mg/kg hydroxyurea. Another 12 subjects received either a high dose (320 mg/kg of SANGUINATE or 15 mg/kg hydroxyurea. The primary endpoint was the safety of SANGUINATE versus hydroxyurea in sickle cell anemia patients. Secondary endpoints included determination of the plasma pharmacokinetics and assessment of hematologic measurements. Results: Musculoskeletal related adverse events were the most common. Transient troponin I levels increased in three patients, one of whom had an increase in tricuspid regurgitant velocity; however, no clinical signs were noted. Following an assessment of vital signs, tricuspid regurgitant velocity, electrocardiogram, serum biochemistry, hematology, urinalysis, and analysis of reported adverse events, SANGUINATE was found to be safe in stable sickle cell anemia patients. Conclusions: The clinical trial met its primary objective of demonstrating an acceptable safety profile for SANGUINATE in patients with sickle cell anemia. This trial established the safety of SANGUINATE at both dose levels and permitted its advance to Phase II trials.

  12. Effects of rasagiline on freezing of gait in Parkinson's disease - an open-label, multicenter study.

    Science.gov (United States)

    Cibulcik, Frantisek; Benetin, Jan; Kurca, Egon; Grofik, Milan; Dvorak, Miloslav; Richter, Denis; Donath, Vladimir; Kothaj, Jan; Minar, Michal; Valkovic, Peter

    2016-12-01

    Freezing of gait is a disabling symptom in advanced Parkinson's disease. Positive effects have been suggested with MAO-B inhibitors. We report on an open label clinical study on the efficacy of rasagiline as add-on therapy on freezing of gait and quality of life in patients with Parkinson's disease. Forty two patients with freezing of gait were treated with 1 mg rasagiline daily as an add-on therapy. Patients were assessed at baseline and after 1, 2 and 3 months of treatment. Freezing of gait severity was assessed using the Freezing of Gait Questionnaire, motor impairment by the modified MDS UPDRS part III, and quality of life using the PDQ-39 questionnaire. Patients treated with rasagiline had a statistically significant decrease in FoG-Q score and modified MDS UPDRS score after 1, 2 and 3 months of therapy. A moderately strong (r = 0.686, P = 0.002) correlation between the effects on mobility and freezing of gait was found. We also observed a statistically significant improvement in global QoL and in the subscales mobility, ADL, stigma and bodily discomfort in patients after 3 months of rasagiline therapy. A significant correlation (r = 0.570, P = 0.02) between baseline FoG-Q score and the baseline score for the PDQ Mobility subscale was found. In our study rasagiline as add-on antiparkinsonian therapy significantly improved mobility, freezing of gait and quality of life. The positive effect on freezing of gait appears to be related to improvement of mobility.

  13. Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.

    Science.gov (United States)

    2017-10-01

    We aimed to explore the longer-term efficacy and safety of edaravone in an active-treatment extension period following the double-blind period of the second phase III study. Patients who met all the following criteria (scores ≥2 points on all 12 items of the revised amyotrophic lateral sclerosis functional rating scale [ALSFRS-R], forced vital capacity ≥80%, definite or probable ALS, and disease duration ≤2 years) were randomised to 60 mg intravenous edaravone or placebo for six cycles in the double-blind period, and then offered the opportunity to proceed to this 24-week open-label extension period. One hundred and twenty-three of 137 patients continued to the extension period: 65 edaravone-edaravone (E-E group) and 58 placebo-edaravone (P-E group). Change (mean ± standard deviation; SD) in the ALSFRS-R score from baseline in the double-blind period was -4.1 ± 3.4 and -6.9 ± 5.1 in the E-E group and P-E group, respectively, while it was -8.0 ± 5.6 in the E-E group and -10.9 ± 6.9 in the P-E group over the whole 48-week period. The ALSFRS-R score changed almost linearly throughout Cycles 1-12 in the E-E group. The most commonly reported adverse events were constipation, dysphagia, and contusion. There was no sudden deterioration in the ALSFRS-R score of the E-E group. No safety concerns related to edaravone were detected.

  14. An open-label trial of L-5-hydroxytryptophan in subjects with romantic stress.

    Science.gov (United States)

    Emanuele, Enzo; Bertona, Marco; Minoretti, Piercarlo; Geroldi, Diego

    2010-01-01

    This open-label trial assessed the clinical efficacy of L-5-hydroxytryptophan (5-HTP), a natural serotonin precursor, in nondepressed young subjects with high levels of romantic stress. Since both neurotrophins and serotonin have been linked to human romantic attachment, we sought to investigate the changes in serum brain-derived neurotrophic factor (BDNF) levels and platelet serotonin content in relation to the changes in romantic stress throughout the study. A total of 15 healthy subjects (11 females and 4 males, mean age: 23.3 ± 2.1 years) who experienced a recent romantic break-up or reported recent romantic problems took part in the study. The participants were treated openly for 6 weeks with L-5-hydroxytryptophan (60 mg Griffonia simplicifolia extract containing 12.8 mg 5-HTP b.i.d., Amorex, Coropharm, Villach, Austria). The subjects were evaluated at baseline, at 3 weeks and at the end of the 6-week trial using an adapted version of the Seiffge-Krenke's Problem Questionnaire. BDNF and platelet serotonin content were determined at baseline, at 3 weeks, and after the completion of the 6-week trial. We observed significant improvements in romantic stress scores from weeks 0 through 3 (p=0.007) but no further significant improvement was evident from weeks 3 through 6 (p=0.19). At 6 weeks, subjects had a significant increase from baseline in both BDNF and platelet serotonin values. Our data suggest that direct modulation of the serotonergic system may have use for the treatment of psychological suffering associated with unreciprocated romantic love.

  15. An open-label study of sodium oxybate (Xyrem®) in spasmodic dysphonia

    Science.gov (United States)

    Rumbach, Anna F.; Blitzer, Andrew; Frucht, Steven J.; Simonyan, Kristina

    2016-01-01

    Objective Spasmodic dysphonia (SD) is a task-specific laryngeal dystonia that affects speech production. Co-occurring voice tremor (VT) often complicates the diagnosis and clinical management of SD. Treatment of SD and VT is largely limited to botulinum toxin injections into laryngeal musculature; other pharmacological options are not sufficiently developed. Study Design and Methods We conducted an open-label study in 23 SD and 22 SD/VT patients to examine the effects of sodium oxybate (Xyrem®), an oral agent with therapeutic effects similar to those of alcohol in these patients. Blinded randomized analysis of voice and speech samples assessed symptom improvement before and after drug administration. Results Sodium oxybate significantly improved voice symptoms (p = 0.001) primarily by reducing the number of SD-characteristic voice breaks and severity of VT. Sodium oxybate further showed a trend for improving VT symptoms (p = 0.03) in a subset of patients who received successful botulinum toxin injections for the management of their SD symptoms. The drug’s effects were observed approximately 30–40 min after its intake and lasted about 3.5–4 hours. Conclusion Our study demonstrated that sodium oxybate reduced voice symptoms in 82.2% of alcohol-responsive SD patients both with and without co-occurring VT. Our findings suggest that the therapeutic mechanism of sodium oxybate in SD and SD/VT may be linked to that of alcohol and as such sodium oxybate might be beneficial for alcohol-responsive SD and SD/VT patients. PMID:27808415

  16. Switching from rivaroxaban to warfarin: an open label pharmacodynamic study in healthy subjects

    Science.gov (United States)

    Moore, Kenneth Todd; Byra, William; Vaidyanathan, Seema; Natarajan, Jaya; Ariyawansa, Jay; Salih, Hiba; Turner, Kenneth C

    2015-01-01

    Aims The primary objective was to explore the pharmacodynamic changes during transition from rivaroxaban to warfarin in healthy subjects. Safety, tolerability and pharmacokinetics were assessed as secondary objectives. Methods An open label, non-randomized, sequential two period study. In treatment period 1 (TP1), subjects received rivaroxaban 20 mg once daily (5 days), followed by co-administration with a warfarin loading dose regimen of 5 or 10 mg (for the 10 mg regimen, the dose could be uptitrated to attain target international normalized ratio [INR] ≥2.0) once daily (2–4 days). When trough INR values ≥2.0 were attained, rivaroxaban was discontinued and warfarin treatment continued as monotherapy (INR 2.0–3.0). During treatment period 2, subjects received the same warfarin regimen as in TP1, but without rivaroxaban. Results During co-administration, maximum INR and prothrombin time (PT) values were higher than with rivaroxaban or warfarin monotherapy. The mean maximum effect (Emax) for INR after co-administration was 2.79–4.15 (mean PT Emax 41.0–62.7 s), compared with 1.41–1.74 (mean PT Emax 20.1–25.2 s) for warfarin alone. However, rivaroxaban had the smallest effect on INR at trough rivaroxaban concentrations. Neither rivaroxaban nor warfarin significantly affected maximum plasma concentrations of the other drug. Conclusions The combined pharmacodynamic effects during co-administration of rivaroxaban and warfarin were greater than additive, but the pharmacokinetics of both drugs were unaffected. Co-administration was well tolerated. When transitioning from rivaroxaban to warfarin, INR monitoring during co-administration should be performed at the trough rivaroxaban concentration to minimize the effect of rivaroxaban on INR. PMID:25475601

  17. The Efficacy of Neurofeedback in Patients with Major Depressive Disorder: An Open Labeled Prospective Study.

    Science.gov (United States)

    Cheon, Eun-Jin; Koo, Bon-Hoon; Choi, Joong-Hyun

    2016-03-01

    The purpose of this study was to evaluate the effect of neurofeedback on depressive symptoms and electrophysiological disturbances in patients with major depressive disorder. We recruited participants suffering from depression to evaluate efficacy of left prefrontal beta with alpha/theta training. An 8-week, prospective, open-label study was undertaken. Twenty participants were recruited. The treatment protocol was twice or three times a week training of beta at F3 with alpha/theta at Pz for 8 weeks. When every visit, patients were received beta training for 30 min, and then alpha/theta training for 30 min. Baseline, 4 and 8 week scores of; the Hamilton rating scale for Depression (HAM-D), the Hamilton rating scale for Anxiety (HAM-A), the Beck Depression Inventory (BDI)-II, the Beck Anxiety Inventory (BAI), Clinical global impression-severity (CGI-S), and pre- and post-treatment resting state EEGs were compared. Interhemispheric alpha power asymmetry (A score) was computed for homologous sites F3-F4. Pre- and post-training clinical assessments revealed significant improvements in HAM-D, HAM-A, BDI, and CGI-S scores. Cumulative response rates by HAM-D were 35.0 and 75.0 % at 4 and 8 weeks, respectively, corresponding cumulative remission rates by HAM-D were 15.0 and 55.0 %, respectively. No significant differences were found between pre- and post-treatment A score. Neurofeedback treatment could improve depressive symptoms significantly. In addition, anxiety symptoms and clinical illness severity decreased significantly after neurofeedback treatment. Despite its several limitations, such as, small sample size and lack of a control group, this study suggested neurofeedback has significant effects in patients with major depressive disorder.

  18. Brief Report: An Open-Label Study of the Neurosteroid Pregnenolone in Adults with Autism Spectrum Disorder

    Science.gov (United States)

    Fung, Lawrence K.; Libove, Robin A.; Phillips, Jennifer; Haddad, Francois; Hardan, Antonio Y.

    2014-01-01

    The objective of this study was to assess the tolerability and efficacy of pregnenolone in reducing irritability in adults with autism spectrum disorder (ASD). This was a pilot, open-label, 12-week trial that included twelve subjects with a mean age of 22.5 ± 5.8 years. Two participants dropped out of the study due to reasons unrelated to adverse…

  19. Comparing the effects of education using telephone follow-up and smartphone-based social networking follow-up on self-management behaviors among patients with hypertension.

    Science.gov (United States)

    Najafi Ghezeljeh, Tahereh; Sharifian, Sanaz; Nasr Isfahani, Mehdi; Haghani, Hamid

    2018-03-05

    Little is known about the benefits of social networks in the management of patients. The aim of this study was to compare the effects of self-management (SM) education using telephone follow-up and mobile phone-based social networking on SM behaviors among patients with hypertension. This randomized clinical trial was conducted with 100 patients. They were randomly allocated to four groups: (i) control, (ii) SM training without follow-up, (iii) telephone follow-up and (iv) smartphone-based social networking follow-up. The hypertension SM behavior questionnaire was used for data collection before and six weeks after the study. Those patients who underwent SM education training (with and without follow-up) had statistically significant differences from those in the control group in terms of SM behaviors (p social networking follow-up influenced SM behaviors among patients with hypertension.

  20. Follow-up after acute respiratory distress syndrome caused by influenza a (H1N1 virus infection

    Directory of Open Access Journals (Sweden)

    Carlos Toufen Jr.

    2011-01-01

    Full Text Available BACKGROUND: There are no reports on the long-term follow-up of patients with swine-origin influenza A virus infection that progressed to acute respiratory distress syndrome. METHODS: Four patients were prospectively followed up with pulmonary function tests and high-resolution computed tomography for six months after admission to an intensive care unit. RESULTS: Pulmonary function test results assessed two months after admission to the intensive care unit showed reduced forced vital capacity in all patients and low diffusion capacity for carbon monoxide in two patients. At six months, pulmonary function test results were available for three patients. Two patients continued to have a restrictive pattern, and none of the patients presented with abnormal diffusion capacity for carbon monoxide. All of them had a diffuse ground-glass pattern on high-resolution computed tomography that improved after six months. CONCLUSIONS: Despite the marked severity of lung disease at admission, patients with acute respiratory distress syndrome caused by swine-origin influenza A virus infection presented a late but substantial recovery over six months of follow-up.

  1. Barriers to follow-up for pediatric cataract surgery in Maharashtra, India: How regular follow-up is important for good outcome. The Miraj Pediatric Cataract Study II

    Directory of Open Access Journals (Sweden)

    Parikshit Gogate

    2014-01-01

    Full Text Available Background: Regular follow up and amblyopia treatment are essential for good outcomes after pediatric cataract surgery. Aim: To study the regularity of follow-up after cataract surgery in children and to gauge the causes of poor compliance to follow up. Subjects: 262 children (393 cataracts who underwent cataract surgery in 2004-8. Materials and Methods: The children were identified and examined in their homes and a "barriers to follow-up" questionnaire completed. Demographic data collected, visual acuity estimated, and ocular examination performed. Statistical Analysis: SPSS version 19. Results: Of the 262 children, only 53 (20.6% had been regularly following up with any hospital, 209 (79.4% had not. A total of 150 (57.3% were boys and the average age was 13.23 years (Std Dev 5 yrs. Poor follow up was associated with the older age group ( P 1 line with regular follow-up. Conclusion: Regular follow-up is important and improves vision; eye care practitioners need to take special efforts to ensure better follow-up.

  2. Phase II open label study of valproic acid in spinal muscular atrophy.

    Directory of Open Access Journals (Sweden)

    Kathryn J Swoboda

    Full Text Available Preliminary in vitro and in vivo studies with valproic acid (VPA in cell lines and patients with spinal muscular atrophy (SMA demonstrate increased expression of SMN, supporting the possibility of therapeutic benefit. We performed an open label trial of VPA in 42 subjects with SMA to assess safety and explore potential outcome measures to help guide design of future controlled clinical trials. Subjects included 2 SMA type I ages 2-3 years, 29 SMA type II ages 2-14 years and 11 type III ages 2-31 years, recruited from a natural history study. VPA was well-tolerated and without evident hepatotoxicity. Carnitine depletion was frequent and temporally associated with increased weakness in two subjects. Exploratory outcome measures included assessment of gross motor function via the modified Hammersmith Functional Motor Scale (MHFMS, electrophysiologic measures of innervation including maximum ulnar compound muscle action potential (CMAP amplitudes and motor unit number estimation (MUNE, body composition and bone density via dual-energy X-ray absorptiometry (DEXA, and quantitative blood SMN mRNA levels. Clear decline in motor function occurred in several subjects in association with weight gain; mean fat mass increased without a corresponding increase in lean mass. We observed an increased mean score on the MHFMS scale in 27 subjects with SMA type II (p

  3. Foley Catheter for Induction of Labor at Term: An Open-Label, Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Ning Gu

    Full Text Available This study aimed to determine the optimal Foley catheter balloon volume (30-mL vs. 80-mL and the maximum time for cervical ripening (12 hours vs. 24 hours to improve vaginal delivery rate within 24 hours of induction.We conducted an open-label, randomized controlled trial in a teaching hospital in China. Women with a term singleton pregnancy, cephalic presentation, intact membrane and an unfavorable cervix (Bishop score <6 were randomly allocated, in 1:1:1:1 ratio, to receive either one of the four treatments: (1 30-mL balloon for a maximum of 12 hours, (2 30-mL balloon for a maximum of 24 hours, (3 80-mL balloon for a maximum of 12 hours, and (4 80-mL balloon for a maximum of 24 hours. The primary outcome was vaginal delivery within 24 hours. Secondary outcomes included cesarean section rate and maternal/neonatal morbidity. Data were analyzed on a per-protocol basis.Five hundred and four women were recruited and randomized (126 women in each group; nine women did not receive the assigned intervention. More women achieved vaginal delivery within 24 hours in 12-hour Foley catheter groups than in the 24-hour Foley catheter groups (30-mL/12 hours: 54.5%, 30-mL/24 hours: 33.1%, 80-mL/12 hours: 46.4%, 80-mL/24 hours: 24.0%, p < 0.001. Cesarean section rates and the incidence of chorioaminonitis were comparable among four groups. After adjustment for confounding factors, both ripening time and balloon size did not affect the proportion of women delivered vaginally within 24 hours of induction.For women with an unfavorable cervix at term, induction of labor with a Foley catheter is safe and effective. Higher balloon volume (80-mL vs. 30-mL and longer ripening time (24 hours vs. 12 hours would not shorten induction to delivery interval or reduce cesarean section rate.Chinese Clinical trial registry (ChiCTR-TRC-13003044.

  4. Effect of autogenic training on drug consumption in patients with primary headache: an 8-month follow-up study.

    Science.gov (United States)

    Zsombok, Terezia; Juhasz, Gabriella; Budavari, Agota; Vitrai, Jozsef; Bagdy, Gyorgy

    2003-03-01

    To examine the effects of Schultz-type autogenic training on headache-related drug consumption and headache frequency in patients with migraine, tension-type, or mixed (migraine plus tension-type) headache over an 8-month period. Behavioral treatments often are used alone or adjunctively for different types of headache. There are, however, only a few studies that have compared the efficacy and durability of the same treatment in different types of primary headache, and the effects of treatment on headache-related drug consumption rarely have been assessed even in these studies. Twenty-five women with primary headache (11 with mixed headache, 8 with migraine, and 6 with tension-type headache) were evaluated via an open-label, self-controlled, 8-month, follow-up study design. After an initial 4 months of observation, patients began learning Schultz-type autogenic training as modified for patients with headache. They practiced autogenic training on a regular basis for 4 months. Based on data from headache diaries and daily medication records, headache frequencies and the amounts of analgesics, "migraine-specific" drugs (ergots and triptans), and anxiolytics taken by the patients were compared in the three subgroups over the 8-month period. Results.-From the first month of implementation of autogenic training, headache frequencies were significantly reduced in patients with tension-type and mixed headache. Significant reduction in frequency was achieved in patients with migraine only from the third month of autogenic training. Decreases in headache frequencies were accompanied by decreases in consumption of migraine drugs and analgesics resulting in significant correlations among these parameters. Reduction in consumption of anxiolytic drugs was more rapid and robust in patients with tension-type headache compared to patients with migraine, and this outcome failed to show any correlation with change in headache frequency. Schultz-type autogenic training is an effective

  5. An open-label dose escalation study to evaluate the safety of administration of nonviral stromal cell-derived factor-1 plasmid to treat symptomatic ischemic heart failure.

    Science.gov (United States)

    Penn, Marc S; Mendelsohn, Farrell O; Schaer, Gary L; Sherman, Warren; Farr, Maryjane; Pastore, Joseph; Rouy, Didier; Clemens, Ruth; Aras, Rahul; Losordo, Douglas W

    2013-03-01

    Preclinical studies indicate that adult stem cells induce tissue repair by activating endogenous stem cells through the stromal cell-derived factor-1:chemokine receptor type 4 axis. JVS-100 is a DNA plasmid encoding human stromal cell-derived factor-1. We tested in a phase 1, open-label, dose-escalation study with 12 months of follow-up in subjects with ischemic cardiomyopathy to see if JVS-100 improves clinical parameters. Seventeen subjects with ischemic cardiomyopathy, New York Heart Association class III heart failure, with an ejection fraction ≤40% on stable medical therapy, were enrolled to receive 5, 15, or 30 mg of JVS-100 via endomyocardial injection. The primary end points for safety and efficacy were at 1 and 4 months, respectively. The primary safety end point was a major adverse cardiac event. Efficacy end points were change in quality of life, New York Heart Association class, 6-minute walk distance, single photon emission computed tomography, N-terminal pro-brain natruretic peptide, and echocardiography at 4 and 12 months. The primary safety end point was met. At 4 months, all of the cohorts demonstrated improvements in 6-minute walk distance, quality of life, and New York Heart Association class. Subjects in the 15- and 30-mg dose groups exhibited improvements in 6-minute walk distance (15 mg: median [range]: 41 minutes [3-61 minutes]; 30 mg: 31 minutes [22-74 minutes]) and quality of life (15 mg: -16 points [+1 to -32 points]; 30 mg: -24 points [+17 to -38 points]) over baseline. At 12 months, improvements in symptoms were maintained. These data highlight the importance of defining the molecular mechanisms of stem cell-based tissue repair and suggest that overexpression of stromal cell-derived factor-1 via gene therapy is a strategy for improving heart failure symptoms in patients with ischemic cardiomyopathy.

  6. Local Heat Application for the Treatment of Buruli Ulcer: Results of a Phase II Open Label Single Center Non Comparative Clinical Trial.

    Science.gov (United States)

    Vogel, Moritz; Bayi, Pierre F; Ruf, Marie-Thérèse; Bratschi, Martin W; Bolz, Miriam; Um Boock, Alphonse; Zwahlen, Marcel; Pluschke, Gerd; Junghanss, Thomas

    2016-02-01

    Buruli ulcer (BU) is a necrotizing skin disease most prevalent among West African children. The causative organism, Mycobacterium ulcerans, is sensitive to temperatures above 37°C. We investigated the safety and efficacy of a local heat application device based on phase change material. In a phase II open label single center noncomparative clinical trial (ISRCTN 72102977) under GCP standards in Cameroon, laboratory confirmed BU patients received up to 8 weeks of heat treatment. We assessed efficacy based on the endpoints 'absence of clinical BU specific features' or 'wound closure' within 6 months ("primary cure"), and 'absence of clinical recurrence within 24 month' ("definite cure"). Of 53 patients 51 (96%) had ulcerative disease. 62% were classified as World Health Organization category II, 19% each as category I and III. The average lesion size was 45 cm(2). Within 6 months after completion of heat treatment 92.4% (49 of 53, 95% confidence interval [CI], 81.8% to 98.0%) achieved cure of their primary lesion. At 24 months follow-up 83.7% (41 of 49, 95% CI, 70.3% to 92.7%) of patients with primary cure remained free of recurrence. Heat treatment was well tolerated; adverse effects were occasional mild local skin reactions. Local thermotherapy is a highly effective, simple, cheap and safe treatment for M. ulcerans disease. It has in particular potential as home-based remedy for BU suspicious lesions at community level where laboratory confirmation is not available. ISRCT 72102977. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America.

  7. OnabotulinumtoxinA (Botox) nerve blocks provide durable pain relief for men with chronic scrotal pain: a pilot open-label trial.

    Science.gov (United States)

    Khambati, Aziz; Lau, Susan; Gordon, Allan; Jarvi, Keith A

    2014-12-01

    Chronic scrotal pain (CSP) is a common, often debilitating, condition affecting approximately 4.75% of men. While nerve blocks using local anesthetics usually provide temporary pain relief, there are no publications on the use of longer acting nerve blocks to provide more durable pain relief for men with CSP. The aim of this study was to determine if onabotulinumtoxinA (Botox) cord blocks provide durable pain relief for men with CSP. In this pilot open-label study, men with CSP who had failed medical management but experienced temporary pain relief from a standard cord block underwent a cord block with 100U Botox. The outcomes measured were changes 1, 3, and 6 months post-Botox injection in (i) a 10-point visual analog scale (VAS) pain score; (ii) scrotal tenderness on a three-point scale as rated by physical examination; and (iii) the Chronic Epididymitis Symptom Index (CESI) to measure the severity and impact of scrotal pain on men. Paired t-tests were used to compare groups. Eighteen patients with CSP seen between April and September 2013 had Botox injected as a cord block. At the 1-month follow-up, pain reduction was reported by 72% of patients (mean VAS score: 7.36 vs. 5.61, P pain reduction and reduced tenderness based on the VAS score (mean: 7.36 vs. 6.02, P pain and tenderness. Our pilot study found that Botox cord blocks provide pain reduction for 3 months or more for most men with CSP. © 2014 International Society for Sexual Medicine.

  8. A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease.

    Science.gov (United States)

    Friedman, Neil J; Butron, Karla; Robledo, Nora; Loudin, James; Baba, Stephanie N; Chayet, Arturo

    2016-01-01

    Dry eye disease (DED), a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED. This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed). Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE) rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations. Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related) were reported. Intraocular pressure remained stable and most subjects showed little or no change in visual acuity at days 30 and 180. No significant findings from other clinical examinations were noted. Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

  9. Modest blood pressure reduction with valsartan in acute ischemic stroke: a prospective, randomized, open-label, blinded-end-point trial.

    Science.gov (United States)

    Oh, Mi Sun; Yu, Kyung-Ho; Hong, Keun-Sik; Kang, Dong-Wha; Park, Jong-Moo; Bae, Hee-Joon; Koo, Jaseong; Lee, Juneyoung; Lee, Byung-Chul

    2015-07-01

    To assess the efficacy and safety of modest blood pressure (BP) reduction with valsartan within 48 h after symptom onset in patients with acute ischemic stroke and high BP. This was a multicenter, prospective, randomized, open-label, blinded-end-point trial. A total of 393 subjects were recruited at 28 centers and then randomly assigned in a 1:1 ratio to receive valsartan (n = 195) or no treatment (n = 198) for seven-days after presentation. The primary outcome was death or dependency, defined as a score of 3-6 on the modified Rankin Scale (mRS) at 90 days after symptom onset. Early neurological deterioration (END) within seven-days and 90-day major vascular events were also assessed. There were 372 patients who completed the 90-day follow-up. The valsartan group had 46 of 187 patients (24·6%) with a 90-day mRS 3-6, compared with 42 of 185 patients (22·6%) in the control group (odds ratio [OR], 1·11; 95% confidence interval [CI], 0·69-1·79; P = 0·667). The rate of major vascular events did not differ between groups (OR, 1·41; 95% CI, 0·44-4·49; P = 0·771). There was a significant increase of END in the valsartan group (OR, 2·43; 95% CI, 1·25-4·73; P = 0·008). Early reduction of BP with valsartan did not reduce death or dependency and major vascular events at 90 days, but increased the risk of END. © 2015 World Stroke Organization.

  10. Prospective, open-label, uncontrolled pilot study to study safety and efficacy of sildenafil in systemic sclerosis-related pulmonary artery hypertension and cutaneous vascular complications.

    Science.gov (United States)

    Kumar, Uma; Sankalp, Gokhale; Gokhle, Sankalp S; Sreenivas, V; Kaur, Satbir; Misra, Durgaprasanna

    2013-04-01

    Pulmonary artery hypertension (PAH) remains the leading cause of morbidity and mortality in systemic sclerosis, while Raynaud's phenomenon and digital ulcers significantly add to the morbidity in systemic sclerosis (SSc). This study was undertaken to evaluate the role of sildenafil in PAH, Raynaud's phenomenon, and digital ulcers in systemic sclerosis patients. A prospective, open-label, uncontrolled pilot study was done at a tertiary care centre in India to study the safety and efficacy of oral sildenafil in PAH, Raynaud's phenomenon, digital infarcts, and ulcers in SSc. Seventeen patients fulfilling ACR classification criteria for scleroderma and having PAH were recruited. Six-minute walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and 2D ECHO were performed in all the study subjects at baseline and at 3 months post-treatment. All patients were treated with oral sildenafil 25 mg three times a day for a period of 3 months. The pre- and post-treatment values of mean pulmonary artery pressure (PAP), 6-min walk test, WHO class of dyspnoea, and severity of Raynaud's phenomenon were compared to look for any significant change. Sixteen patients who completed 3-month follow-up had shown statistically significant improvement in 6-min walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and mPAP. Also, there was no occurrence of new digital infarcts or ulcers, and existing ulcers showed signs of healing. Sildenafil is highly efficacious cheaper and safe alternative to other available therapies for SSc-associated PAH, Raynaud's phenomenon, and digital infarcts/ulcers.

  11. Can follow-up controls improve the confidence of MR of the breast? A retrospective analysis of follow-up MR images of the breast

    International Nuclear Information System (INIS)

    Betsch, A.; Arndt, E.; Stern, W.; Claussen, C.D.; Mueller-Schimpfle, M.; Wallwiener, D.

    2001-01-01

    Purpose: To assess the change in diagnostic confidence between first and follow-up dynamic MR examination of the breast (MRM). Methods: The reports of a total of 175 MRM in 77 patients (mean age 50 years; 36-76) with 98 follow-up MRM were analyzed. All examinations were performed as a dynamic study (Gd-DTPA, 0.16 mmol/kg; 6-7 repetitive studies). The change in diagnostic confidence was retrospectively classified as follows: Controlled lesion vanished during follow-up (category I); diagnostic confidence increases during follow-up (II), more likely benign (IIa), more suspicious (IIb); no difference in diagnostic confidence (III). Long-term follow-up over an average of four years was obtained for 57 patients with category IIa/III findings. Results: In 98 follow-up examinations, only two lesions vanished (2%). In 77/98 cases a category IIa lesion was diagnosed, in 11 cases a category IIb lesion. In 8 cases (8%) there was no change in diagnostic confidence during follow-up. Lesions in category IIb underwent biopsy in 10/11 cases, in one case long-term follow-up proved a completely regredient inflammatory change. In 8/11 suspicious findings (IIb) a malignant tumor was detected. The mean time interval between first and follow-up MRM was 8 months for I-IIb lesions, and 4 months for category III lesions. In the longterm follow-up two patients with a category II a lesion developed a carcinoma in a different breast area after four and five years. Conclusion: MRM follow up increases the diagnostic confidence if the time interval is adequate (>4 months). A persistently or increasingly suspicious finding warrants biopsy. (orig.) [de

  12. A Longitudinal Follow-Up Study of Saffron Supplementation in Early Age-Related Macular Degeneration: Sustained Benefits to Central Retinal Function

    Directory of Open Access Journals (Sweden)

    M. Piccardi

    2012-01-01

    Full Text Available Objectives. In a previous randomized clinical trial (Falsini et al. (2010, it was shown that short-term Saffron supplementation improves retinal flicker sensitivity in early age-related macular degeneration (AMD. The aim of this study was to evaluate whether the observed functional benefits from Saffron supplementation may extend over a longer follow-up duration. Design. Longitudinal, interventional open-label study. Setting. Outpatient ophthalmology setting. Participants. Twenty-nine early AMD patients (age range: 55–85 years with a baseline visual acuity >0.3. Intervention. Saffron oral supplementation (20 mg/day over an average period of treatment of 14 (±2 months. Measurements. Clinical examination and focal-electroretinogram-(fERG- derived macular (18° flicker sensitivity estimate (Falsini et al. (2010 every three months over a followup of 14 (±2 months. Retinal sensitivity, the reciprocal value of the estimated fERG amplitude threshold, was the main outcome measure. Results. After three months of supplementation, mean fERG sensitivity improved by 0.3 log units compared to baseline values (P<0.01, and mean visual acuity improved by two Snellen lines compared to baseline values (0.75 to 0.9, P<0.01. These changes remained stable over the follow-up period. Conclusion. These results indicate that in early AMD Saffron supplementation induces macular function improvements from baseline that are extended over a long-term followup.

  13. Effect of heart failure reversal treatment as add-on therapy in patients with chronic heart failure: A randomized, open-label study.

    Science.gov (United States)

    Sane, Rohit; Aklujkar, Abhijeet; Patil, Atul; Mandole, Rahul

    The present study was designed to evaluate effect of heart failure reversal therapy (HFRT) using herbal procedure (panchakarma) and allied therapies, as add-on to standard CHF treatment (SCT) in chronic heart failure (CHF) patients. This open-label, randomized study conducted in CHF patients (aged: 25-65 years, ejection fraction: 30-65%), had 3-phases: 1-week screening, 6-week treatment (randomized [1:1] to HFRT+SCT or SCT-alone) and follow-up (12-week). Twice weekly HFRT (60-75min) consisting of snehana (external oleation), swedana (passive heat therapy), hrudaydhara (concoction dripping treatment) and basti (enema) was administered. Primary endpoints included evaluation of change in metabolic equivalents of task (MET) and peak oxygen uptake (VO 2peak ) from baseline, at end of 6-week treatment and follow-up at week-18 (non-parametric rank ANCOVA analysis). Safety and quality of life (QoL) was assessed. Seventy CHF patients (n=35, each treatment-arm; mean [SD] age: 53.0 [8.6], 80% men) were enrolled in the study. All patients completed treatment phase. Add-on HFRT caused a significant increase in METs (least square mean difference [LSMD], 6-week: 1.536, p=0.0002; 18-week: -1.254, p=0.0089) and VO 2peak (LSMD, 6-week: -5.52, p=0.0002; 18-week: -4.517, p=0.0089) as compared with SCT-alone. Results were suggestive of improved functional capacity in patients with HFRT (QoL; Mean [SD] HFRT+SCT vs. SCT-alone; 6-week: -0.44 [0.34] vs. -0.06 [0.25], p<0.0001 and 18-week: -0.53 [0.35] vs. -0.29 [0.26], p=0.0013). Seven treatment-emergent adverse events (mild severity) were reported in HFRT-arm. Findings of this study highlight therapeutic efficacy of add-on HFRT vs. SCT-alone in CHF patients. The non-invasive HFRT showed no safety concerns. Copyright © 2016. Published by Elsevier B.V.

  14. Single-arm open-label study of Durolane (NASHA nonanimal hyaluronic acid for the treatment of osteoarthritis of the thumb

    Directory of Open Access Journals (Sweden)

    Velasco E

    2017-03-01

    Full Text Available Eloisa Velasco,1 Mª Victoria Ribera,2 Joan Pi3 1Department of Orthopedic Surgery, Hospital de Sant Joan Despí Moisés Broggi, Barcelona, Spain; 2Department of Anesthesiology, Vall d’Hebron University Hospital, Barcelona, Spain; 3Department of Orthopedics and Traumatology, Parc Taulí University Hospital, Sabadell, Barcelona, Spain Introduction: Osteoarthritis of the trapeziometacarpal (TMC joint of the thumb – also known as rhizarthrosis – is painful and has a significant impact on quality of life. Intra-articular injection of hyaluronic acid may potentially meet the need for effective, minimally invasive intervention in patients not responding adequately to initial treatment. We aimed to confirm the safety and effectiveness of viscosupplementation with Durolane (NASHA nonanimal hyaluronic acid in rhizarthrosis.Patients and methods: This was a prospective, single-arm, multicenter, open-label study with a 6-month follow-up period. Eligible patients had Eaton–Littler grade II–III rhizarthrosis in one TMC joint with pain and visual analog scale (VAS pain score ≥4 (scale: 0–10. A single injection of NASHA was administered to the affected TMC joint. The primary effectiveness variable was change from baseline in VAS pain score.Results: Thirty-five patients (mean age 60.8 years; 85.7% female received NASHA and completed the study. The least-squares mean change from baseline in VAS pain score over 6 months was –2.00, a reduction of 27.8% (p<0.001. The reduction in pain exceeded 25% as early as month 1 (26.5%, and gradual improvement was observed throughout the 6-month follow-up period. Secondary effectiveness parameters included QuickDASH (shortened version of Disabilities of the Arm, Shoulder, and Hand [DASH], Kapandji thumb opposition test, radial abduction, metacarpophalangeal (MCP joint flexion, and pinch (clamp strength. Most of these measurements showed statistically significant improvements from baseline over 6 months. Five

  15. Alternating Mupirocin/Gentamicin is Associated with Increased Risk of Fungal Peritonitis as Compared with Gentamicin Alone - Results of a Randomized Open-Label Controlled Trial.

    Science.gov (United States)

    Wong, Ping-Nam; Tong, Gensy M W; Wong, Yuk-Yi; Lo, Kin-Yee; Chan, Shuk-Fan; Lo, Man-Wai; Lo, Kwok-Chi; Ho, Lo-Yi; Tse, Cindy W S; Mak, Siu-Ka; Wong, Andrew K M

    2016-01-01

    ♦ Catheter-related infection, namely exit-site infection (ESI) and peritonitis, is a major infectious complication and remains a main cause of technique failure for patients receiving peritoneal dialysis (PD). Topical application of antibiotic cream might reduce catheter-related infection but emergence of resistant or opportunistic organisms could be a concern. Optimal topical agents and regimens remain to be determined. We did a study to examine the effect of an alternating topical antibiotic regimen in preventing catheter-related infection. ♦ We performed a single-center, randomized, open-label study to compare daily topical application of gentamicin cream with a gentamicin/mupirocin alternate regimen to the exit site. Patients randomized to alternating regimen were asked to have daily application of gentamicin cream in odd months and mupirocin cream in even months. Primary outcomes were ESI and peritonitis. Secondary outcomes were catheter removal or death caused by catheter-related infection. A total of 146 patients (71, gentamicin group; 75, alternating regimen group) were enrolled with a total follow-up duration of 174 and 181 patient-years for gentamicin and alternating groups, respectively. All patients were followed up until catheter removal, death, transfer to another unit, transplantation or the end of the study on March 31, 2014. There were no significant differences in the age, sex, dialysis vintage, and rate of diabetes, helper-assisted dialysis and methicillin-resistant Staphylococcus aureus (MRSA) carriage state. ♦ No difference was seen in the time to first ESI or peritonitis. However, the time to first gram-negative peritonitis seemed longer for the gentamicin group (p = 0.055). The 2 groups showed a similar rate of ESI (0.17/yr vs 0.19/yr, p = 0.93) but P. aeruginosa ESI was less common in the gentamicin group (0.06/yr vs 0.11/yr, p Peritonitis rate was significantly lower in the gentamicin group (0.22/yr vs 0.32/yr, p peritonitis (0.08/yr

  16. Adjunctive agomelatine therapy in the treatment of acute bipolar II depression: a preliminary open label study

    Directory of Open Access Journals (Sweden)

    Fornaro M

    2013-02-01

    Full Text Available Michele Fornaro,1 Michael J McCarthy,2,3 Domenico De Berardis,4 Concetta De Pasquale,1 Massimo Tabaton,5 Matteo Martino,6 Salvatore Colicchio,7 Carlo Ignazio Cattaneo,8 Emanuela D'Angelo,9 Pantaleo Fornaro61Department of Formative Sciences, University of Catania, Catania, Italy; 2Department of Psychiatry, Veteran's Affairs San Diego Healthcare System, 3University of California San Diego, La Jolla, CA, USA; 4Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, "ASL 4", Teramo, Italy; 5Department of Internal Medicine and Medical Specialties, University of Genova, Genoa, Italy; 6Department of Neurosciences, Section of Psychiatry, University of Genova, Genoa, Italy; 7Unit of Sleep Medicine, Department of Neuroscience, Catholic University, Rome, Italy; 8National Health System, "ASL 13", Novara, Italy; 9National Health System, "ASL 3", Genoa, ItalyPurpose: The circadian rhythm hypothesis of bipolar disorder (BD suggests a role for melatonin in regulating mood, thus extending the interest toward the melatonergic antidepressant agomelatine as well as type I (acute or II cases of bipolar depression.Patients and methods: Twenty-eight depressed BD-II patients received open label agomelatine (25 mg/bedtime for 6 consecutive weeks as an adjunct to treatment with lithium or valproate, followed by an optional treatment extension of 30 weeks. Measures included the Hamilton depression scale, Pittsburgh Sleep Quality Index, the Clinical Global Impression Scale–Bipolar Version, Young Mania Rating Scale, and body mass index.Results: Intent to treat analysis results demonstrated that 18 of the 28 subjects (64% showed medication response after 6 weeks (primary study endpoint, while 24 of the 28 subjects (86% responded by 36 weeks. When examining primary mood stabilizer treatment, 12 of the 17 (70.6% valproate and six of the 11 (54.5% lithium patients responded by the first endpoint. At 36 weeks, 14 valproate treated (82.4% and 10 lithium

  17. Gatifloxacin versus chloramphenicol for uncomplicated enteric fever: an open-label, randomised, controlled trial.

    Science.gov (United States)

    Arjyal, Amit; Basnyat, Buddha; Koirala, Samir; Karkey, Abhilasha; Dongol, Sabina; Agrawaal, Krishna Kumar; Shakya, Nikki; Shrestha, Kabina; Sharma, Manish; Lama, Sanju; Shrestha, Kasturi; Khatri, Nely Shrestha; Shrestha, Umesh; Campbell, James I; Baker, Stephen; Farrar, Jeremy; Wolbers, Marcel; Dolecek, Christiane

    2011-06-01

    We aimed to investigate whether gatifloxacin, a new generation and affordable fluoroquinolone, is better than chloramphenicol for the treatment of uncomplicated enteric fever in children and adults. We did an open-label randomised superiority trial at Patan Hospital, Kathmandu, Nepal, to investigate whether gatifloxacin is more effective than chloramphenicol for treating uncomplicated enteric fever. Children and adults clinically diagnosed with enteric fever received either gatifloxacin (10 mg/kg) once a day for 7 days, or chloramphenicol (75 mg/kg per day) in four divided doses for 14 days. Patients were randomly allocated treatment (1:1) in blocks of 50, without stratification. Allocations were placed in sealed envelopes opened by the study physician once a patient was enrolled into the trial. Masking was not possible because of the different formulations and ways of giving the two drugs. The primary outcome measure was treatment failure, which consisted of at least one of the following: persistent fever at day 10, need for rescue treatment, microbiological failure, relapse until day 31, and enteric-fever-related complications. The primary outcome was assessed in all patients randomly allocated treatment and reported separately for culture-positive patients and for all patients. Secondary outcome measures were fever clearance time, late relapse, and faecal carriage. The trial is registered on controlled-trials.com, number ISRCTN 53258327. 844 patients with a median age of 16 (IQR 9-22) years were enrolled in the trial and randomly allocated a treatment. 352 patients had blood-culture-confirmed enteric fever: 175 were treated with chloramphenicol and 177 with gatifloxacin. 14 patients had treatment failure in the chloramphenicol group, compared with 12 in the gatifloxacin group (hazard ratio [HR] of time to failure 0·86, 95% CI 0·40-1·86, p=0·70). The median time to fever clearance was 3·95 days (95% CI 3·68-4·68) in the chloramphenicol group and 3·90 days

  18. Primary care follow-up of radical prostatectomy patients: A regional New Zealand experience

    Directory of Open Access Journals (Sweden)

    Omid Yassaie

    2016-12-01

    Conclusion: Our study identified that follow-up by GPs after RP is insufficient. Accordingly, there is a requirement for formal educational programs if primary care is to take a greater role in follow-up of these patients.

  19. Patients highly value routine follow-up of skin cancer and cutaneous melanoma

    DEFF Research Database (Denmark)

    Themstrup, Lotte; Jemec, Gregor E; Lock-Andersen, Jørgen

    2013-01-01

    INTRODUCTION: Skin cancer follow-up is a substantial burden to outpatient clinics. Few studies have investigated patients' views on skin cancer follow-up and cutaneous melanoma. The objective was to investigate patients' perceived benefits and the impact of follow-up. MATERIAL AND METHODS...

  20. The impact of phone calls on follow-up rates in an online depression prevention study

    Directory of Open Access Journals (Sweden)

    R.F. Muñoz

    2017-06-01

    Conclusions: Adding phone call contacts to email reminders and monetary incentives did increase follow-up rates. However, the rate of response to follow-up was low and the number of phone calls required to achieve one completed follow-up raises concerns about the utility of adding phone calls. We also discuss difficulties with using financial incentives and their implications.

  1. Value of routine timed barium esophagram follow-up in achalasia after myotomy.

    Science.gov (United States)

    Kachala, Stefan S; Rice, Thomas W; Baker, Mark E; Rajeswaran, Jeevanantham; Thota, Prashanthi N; Murthy, Sudish C; Blackstone, Eugene H; Zanoni, Andrea; Raja, Siva

    2018-03-08

    The value of routine timed barium esophagram (TBE) in longitudinal follow-up of achalasia after Heller myotomy is unknown. We prospectively prescribed a yearly follow-up TBE. Purposes were to characterize esophageal emptying over time after myotomy, identify preoperative TBE measures associated with follow-up TBE, and characterize follow-up TBE over time in relationship to reintervention. From March 1995 to April 2013, 635 patients underwent Heller myotomy for achalasia; 559 had at least 1 follow-up TBE. Temporal trends of 1335 follow-up TBEs in all nonreintervention and reintervention patients were assessed. Multivariable longitudinal analysis identified preoperative TBE measures associated with follow-up TBE. On average, TBE height and width at 1 and 5 minutes decreased approximately 50% and 60%, respectively, at first postoperative follow-up, and remained stable or slightly decreased for up to 5 years. Wider TBE width at 5 minutes was associated with greater follow-up TBE height and width at 1 minute. Of 118 patients undergoing reintervention, 64 (57%) had only 1 reintervention, with follow-up TBE returning to that of nonreintervention patients. Patients whose follow-up TBE remained abnormal underwent a further reintervention, some normalizing on subsequent TBE, and some not. Follow-up TBE is valuable postmyotomy, particularly if there is substantial esophageal dilatation preoperatively. Follow-up TBE reassures patients with stable or decreasing TBE measures, permitting decreased follow-up intensity. Reintervention should not be considered a myotomy failure, because a successful, single, nonsurgical reintervention often results in long-term successful palliation. More than 1 reintervention requires intensification of TBE follow-up, facilitating treatment planning. Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  2. Methadone continuation versus forced withdrawal on incarceration in a combined US prison and jail: a randomised, open-label trial.

    Science.gov (United States)

    Rich, Josiah D; McKenzie, Michelle; Larney, Sarah; Wong, John B; Tran, Liem; Clarke, Jennifer; Noska, Amanda; Reddy, Manasa; Zaller, Nickolas

    2015-07-25

    Methadone is an effective treatment for opioid dependence. When people who are receiving methadone maintenance treatment for opioid dependence are incarcerated in prison or jail, most US correctional facilities discontinue their methadone treatment, either gradually, or more often, abruptly. This discontinuation can cause uncomfortable symptoms of withdrawal and renders prisoners susceptible to relapse and overdose on release. We aimed to study the effect of forced withdrawal from methadone upon incarceration on individuals' risk behaviours and engagement with post-release treatment programmes. In this randomised, open-label trial, we randomly assigned (1:1) inmates of the Rhode Island Department of Corrections (RI, USA) who were enrolled in a methadone maintenance-treatment programme in the community at the time of arrest and wanted to remain on methadone treatment during incarceration and on release, to either continuation of their methadone treatment or to usual care--forced tapered withdrawal from methadone. Participants could be included in the study only if their incarceration would be more than 1 week but less than 6 months. We did the random assignments with a computer-generated random permutation, and urn randomisation procedures to stratify participants by sex and race. Participants in the continued-methadone group were maintained on their methadone dose at the time of their incarceration (with dose adjustments as clinically indicated). Patients in the forced-withdrawal group followed the institution's standard withdrawal protocol of receiving methadone for 1 week at the dose at the time of their incarceration, then a tapered withdrawal regimen (for those on a starting dose >100 mg, the dose was reduced by 5 mg per day to 100 mg, then reduced by 3 mg per day to 0 mg; for those on a starting dose >100 mg, the dose was reduced by 3 mg per day to 0 mg). The main outcomes were engagement with a methadone maintenance-treatment clinic after release from

  3. Adjuvant capecitabine plus bevacizumab versus capecitabine alone in patients with colorectal cancer (QUASAR 2): an open-label, randomised phase 3 trial.

    Science.gov (United States)

    Kerr, Rachel S; Love, Sharon; Segelov, Eva; Johnstone, Elaine; Falcon, Beverly; Hewett, Peter; Weaver, Andrew; Church, David; Scudder, Claire; Pearson, Sarah; Julier, Patrick; Pezzella, Francesco; Tomlinson, Ian; Domingo, Enric; Kerr, David J

    2016-11-01

    Antiangiogenic agents have established efficacy in the treatment of metastatic colorectal cancer. We investigated whether bevacizumab could improve disease-free survival in the adjuvant setting after resection of the primary tumour. For the open-label, randomised, controlled QUASAR 2 trial, which was done at 170 hospitals in seven countries, we recruited patients aged 18 years or older with WHO performance status scores of 0 or 1 who had undergone potentially curative surgery for histologically proven stage III or high-risk stage II colorectal cancer. Patients were randomly assigned (1:1) to receive eight 3-week cycles of oral capecitabine alone (1250 mg/m 2 twice daily for 14 days followed by a break for 7 days) or the same regimen of oral capecitabine plus 16 cycles of 7·5 mg/kg bevacizumab by intravenous infusion over 90 min on day 1 of each cycle. Randomisation was done by a computer-generated schedule with use of minimisation with a random element stratified by age, disease stage, tumour site, and country. The study was open label and no-one was masked to treatment assignment. The primary endpoint was 3-year disease-free survival, assessed in the intention-to-treat population. Toxic effects were assessed in patients who received at least one dose of randomised treatment. This trial is registered with the ISRCTN registry, number ISRCTN45133151. Between April 25, 2005, and Oct 12, 2010, 1952 eligible patients were enrolled, of whom 1941 had assessable data (968 in the capecitabine alone group and 973 in the capecitabine and bevacizumab group). Median follow-up was 4·92 years (IQR 4·00-5·16). Disease-free survival at 3 years did not differ between the groups (75·4%, 95% CI 72·5-78·0 in the capecitabine and bevacizumab group vs 78·4%, 75·7-80·9 in the capecitabine alone group; hazard ratio 1·06, 95% CI 0·89-1·25, p=0·54). The most common grade 3-4 adverse events were hand-foot syndrome (201 [21%] of 963 in the capecitabine alone group vs 257 [27%] of

  4. Focused Ultrasound Lipolysis in the Treatment of Abdominal Cellulite: An Open-Label Study

    Science.gov (United States)

    Moravvej, Hamideh; Akbari, Zahra; Mohammadian, Shahrzad; Razzaghi, Zahra

    2015-01-01

    Introduction: Despite a growing popularity of noninvasive ultrasonic lipolysis procedure, there is a lack of evidence about the efficacy of this method. This study was performed to evaluate the efficacy of focused ultrasonic lipolysis on abdominal cellulite treatment. Methods: Twenty-eight consecutive subjects (age: 37.8 ± 8 years) underwent weekly transdermal focused ultrasonic lipolysis (Med Contour, General Project Ltd., Florence, Italy) and vacuum drainage for a maximum of eight sessions. Largest abdominal girth and 2 lines at 4 cm to 7 cm distance above and under it were located as fixed points of measurements. The mean value of the three fixed lines was considered as the abdominal circumference. Subjects were evaluated using measurements of circumference, immediately after and 3 weeks after the final treatment and compared using paired t test. Results: One hundred ninety-four ultrasonic lipolysis procedures were performed on 28 subjects. A statistically significant (P cellulite, although some amount of circumference reduction reversal may be observed in long term follow-up visit. PMID:26464776

  5. Yoga-based intervention in patients with somatoform disorders: an open label trial.

    Science.gov (United States)

    Sutar, Roshan; Desai, Geetha; Varambally, Shivarama; Gangadhar, B N

    2016-06-01

    Somatoform disorders are common mental disorders associated with impaired functioning and increased utilization of health resources. Yoga-based interventions have been used successfully for anxiety, depression, and chronic pain conditions. However, literature on the use of yoga in treatment of somatoform disorders is minimal. The current study assessed the effect of a specific yoga-based intervention in patients with somatoform disorders. Consenting patients meeting ICD-10 criteria for somatoform disorders were offered a specific yoga module (1 h per day) as a treatment. Assessments including Visual Analogue Scale (VAS), Brief Pain Inventory (BPI), and others were carried out at baseline and after 2, 6, and 12 weeks. Sixty-four subjects were included in the study and 34 completed 12 weeks follow-up. Significant improvement was noted in pain severity from baseline to 12 weeks after regular yoga sessions. The mean VAS score dropped from 7.24 to 2.88. Worst and average pain score in the last 24 h on BPI dropped from 7.71 to 3.26 and from 6.12 to 2.0,7 respectively. Results of the study suggest that yoga-based intervention can be one of the non-pharmacological treatment options in somatoform disorders. These preliminary findings need replication in larger controlled studies.

  6. Prospective open-label study of add-on and monotherapy topiramate in civilians with chronic nonhallucinatory posttraumatic stress disorder

    Directory of Open Access Journals (Sweden)

    Berlant Jeffrey L

    2004-08-01

    Full Text Available Abstract Background In order to confirm therapeutic effects of topiramate on posttraumatic stress disorder (PTSD observed in a prior study, a new prospective, open-label study was conducted to examine acute responses in chronic, nonhallucinatory PTSD. Methods Thirty-three consecutive newly recruited civilian adult outpatients (mean age 46 years, 85% female with DSM-IV-diagnosed chronic PTSD, excluding those with concurrent auditory or visual hallucinations, received topiramate either as monotherapy (n = 5 or augmentation (n = 28. The primary measure was a change in the PTSD Checklist-Civilian Version (PCL-C score from baseline to 4 weeks, with response defined as a ≥ 30% reduction of PTSD symptoms. Results For those taking the PCL-C at both baseline and week 4 (n = 30, total symptoms declined by 49% at week 4 (paired t-test, P Conclusions Promising open-label findings in a new sample converge with findings of a previous study. The use of topiramate for treatment of chronic PTSD, at least in civilians, warrants controlled clinical trials.

  7. The efficacy of N-acetylcysteine as an adjunctive treatment in bipolar depression: an open label trial.

    Science.gov (United States)

    Berk, Michael; Dean, Olivia; Cotton, Sue M; Gama, Clarissa S; Kapczinski, Flavio; Fernandes, Brisa S; Kohlmann, Kristy; Jeavons, Susan; Hewitt, Karen; Allwang, Christine; Cobb, Heidi; Bush, Ashley I; Schapkaitz, Ian; Dodd, Seetal; Malhi, Gin S

    2011-12-01

    Evidence is accumulating to support the presence of redox dysregulation in a number of psychiatric disorders, including bipolar disorder. This dysregulation may be amenable to therapeutic intervention. Glutathione is the predominant non-enzymatic intracellular free radical scavenger in the brain, and the most generic of all endogenous antioxidants in terms of action. N-acetylcysteine (NAC) is a glutathione precursor that effectively replenishes brain glutathione. Given the failure of almost all modern trials of antidepressants in bipolar disorder to demonstrate efficacy, and the limited efficacy of mood stabilisers in the depressive phase of the disorder, this is a major unmet need. This study reports data on the treatment of 149 individuals with moderate depression during the 2 month open label phase of a randomised placebo controlled clinical trial of the efficacy of 1g BID of NAC that examined the use of NAC as a maintenance treatment for bipolar disorder. In this trial, the estimated mean baseline Bipolar Depression Rating Scale (BDRS) score was 19.7 (SE=0.8), and the mean BDRS score at the end of the 8 week open label treatment phase was 11.1 (SE=0.8). This reduction was statistically significant (pdepression scores with NAC treatment. Large placebo controlled trials of acute bipolar depression are warranted. Copyright © 2011 Elsevier B.V. All rights reserved.

  8. Intermittent theta-burst transcranial magnetic stimulation for autism spectrum disorder: an open-label pilot study

    Directory of Open Access Journals (Sweden)

    Caio Abujadi

    2017-12-01

    Full Text Available Objective: Theta-burst stimulation (TBS modulates synaptic plasticity more efficiently than standard repetitive transcranial magnetic stimulation delivery and may be a promising modality for neuropsychiatric disorders such as autism spectrum disorder (ASD. At present there are few effective interventions for prefrontal cortex dysfunction in ASD. We report on an open-label, pilot study of intermittent TBS (iTBS to target executive function deficits and restricted, repetitive behaviors in male children and adolescents with ASD. Methods: Ten right-handed, male participants, aged 9-17 years with ASD were enrolled in an open-label trial of iTBS treatment. Fifteen sessions of neuronavigated iTBS at 100% motor threshold targeting the right dorsolateral prefrontal cortex were delivered over 3 weeks. Results: Parent report scores on the Repetitive Behavior Scale Revised and the Yale-Brown Obsessive Compulsive Scale demonstrated improvements with iTBS treatment. Participants demonstrated improvements in perseverative errors on the Wisconsin Card Sorting Test and total time for the Stroop test. The iTBS treatments were well tolerated with no serious adverse effects. Conclusion: These preliminary results suggest that further controlled interventional studies of iTBS for ASD are warranted.

  9. Intermittent theta-burst transcranial magnetic stimulation for autism spectrum disorder: an open-label pilot study.

    Science.gov (United States)

    Abujadi, Caio; Croarkin, Paul E; Bellini, Bianca B; Brentani, Helena; Marcolin, Marco A

    2017-12-11

    Theta-burst stimulation (TBS) modulates synaptic plasticity more efficiently than standard repetitive transcranial magnetic stimulation delivery and may be a promising modality for neuropsychiatric disorders such as autism spectrum disorder (ASD). At present there are few effective interventions for prefrontal cortex dysfunction in ASD. We report on an open-label, pilot study of intermittent TBS (iTBS) to target executive function deficits and restricted, repetitive behaviors in male children and adolescents with ASD. Ten right-handed, male participants, aged 9-17 years with ASD were enrolled in an open-label trial of iTBS treatment. Fifteen sessions of neuronavigated iTBS at 100% motor threshold targeting the right dorsolateral prefrontal cortex were delivered over 3 weeks. Parent report scores on the Repetitive Behavior Scale Revised and the Yale-Brown Obsessive Compulsive Scale demonstrated improvements with iTBS treatment. Participants demonstrated improvements in perseverative errors on the Wisconsin Card Sorting Test and total time for the Stroop test. The iTBS treatments were well tolerated with no serious adverse effects. These preliminary results suggest that further controlled interventional studies of iTBS for ASD are warranted.

  10. Follow-up skeletal surveys for nonaccidental trauma: can a more limited survey be performed?

    Energy Technology Data Exchange (ETDEWEB)

    Harlan, Susan R. [University of Utah School of Medicine, Department of Radiology, Salt Lake City, UT (United States); Nixon, G.W.; Prince, Jeffrey S. [Primary Children' s Medical Center, Department of Medical Imaging, Salt Lake City, UT (United States); Campbell, Kristine A.; Hansen, Karen [University of Utah School of Medicine, Department of Pediatrics, Salt Lake City, UT (United States)

    2009-09-15

    Studies have demonstrated the value of the follow-up skeletal survey in identifying additional fractures, clarifying indeterminate findings, and improving dating of skeletal injuries in victims of physical abuse. To determine whether a more limited follow-up survey could yield the same radiologic data as a full follow-up survey. The study cohort comprised 101 children who had follow-up surveys that met our inclusion criteria. Consensus readings of both original and follow-up surveys were performed by two pediatric radiologists. These results were compared to determine additional findings from the follow-up surveys. Limited skeletal survey protocols were evaluated to determine whether they would detect the same fractures seen with a complete osseous survey. In the 101 children 244 fractures were identified on the initial osseous survey. Follow-up surveys demonstrated new information in 38 children (37.6%). A 15-view limited follow-up survey identified all additional information seen on the complete follow-up survey. Our data demonstrate that a 15-view limited follow-up skeletal survey could be performed without missing clinically significant new fractures and still allow proper identification of confirmed fractures or normal findings. A limited survey would decrease radiation dose in children. (orig.)

  11. Follow-up skeletal surveys for nonaccidental trauma: can a more limited survey be performed?

    International Nuclear Information System (INIS)

    Harlan, Susan R.; Nixon, G.W.; Prince, Jeffrey S.; Campbell, Kristine A.; Hansen, Karen

    2009-01-01

    Studies have demonstrated the value of the follow-up skeletal survey in identifying additional fractures, clarifying indeterminate findings, and improving dating of skeletal injuries in victims of physical abuse. To determine whether a more limited follow-up survey could yield the same radiologic data as a full follow-up survey. The study cohort comprised 101 children who had follow-up surveys that met our inclusion criteria. Consensus readings of both original and follow-up surveys were performed by two pediatric radiologists. These results were compared to determine additional findings from the follow-up surveys. Limited skeletal survey protocols were evaluated to determine whether they would detect the same fractures seen with a complete osseous survey. In the 101 children 244 fractures were identified on the initial osseous survey. Follow-up surveys demonstrated new information in 38 children (37.6%). A 15-view limited follow-up survey identified all additional information seen on the complete follow-up survey. Our data demonstrate that a 15-view limited follow-up skeletal survey could be performed without missing clinically significant new fractures and still allow proper identification of confirmed fractures or normal findings. A limited survey would decrease radiation dose in children. (orig.)

  12. Effects of EAP follow-up on prevention of relapse among substance abuse clients.

    Science.gov (United States)

    Foote, A; Erfurt, J C

    1991-05-01

    Clients entering an employee assistance program (EAP) of a large manufacturing plant in 1985 who were assessed as having an alcohol or drug abuse problem (N = 325) were randomized into an experimental "special follow-up" group and a control "regular care" group. The regular care group received follow-up only as needed (following the usual practice of the EAP), while a follow-up counselor was hired to make routine contacts with the special follow-up group. Study intake continued through 1985, and follow-up continued through the end of 1986. Data collected on study subjects included EAP participation data, absenteeism, number of hospitalizations, health care claims paid and disability claims paid. The major study hypothesis was that EAP clients randomly allocated to special follow-up would show better results than regular care clients (i.e., would have fewer relapses, better job attendance and lower health benefit utilization during the follow-up year). The follow-up intervention was incompletely implemented due to a variety of organizational problems. Differences between the two groups on the six outcome measures were not statistically significant, although clients in the special follow-up group did show better results than clients in the regular care group on the three measures related to substance abuse. Differences on these three measures were marginally significant in regression analyses after controlling for the effects of number of follow-up visits, age, race and chronicity.

  13. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial.

    Science.gov (United States)

    Basset-Seguin, Nicole; Hauschild, Axel; Grob, Jean-Jacques; Kunstfeld, Rainer; Dréno, Brigitte; Mortier, Laurent; Ascierto, Paolo A; Licitra, Lisa; Dutriaux, Caroline; Thomas, Luc; Jouary, Thomas; Meyer, Nicolas; Guillot, Bernard; Dummer, Reinhard; Fife, Kate; Ernst, D Scott; Williams, Sarah; Fittipaldo, Alberto; Xynos, Ioannis; Hansson, Johan

    2015-06-01

    The Hedgehog pathway inhibitor vismodegib has shown clinical benefit in patients with advanced basal cell carcinoma and is approved for treatment of patients with advanced basal cell carcinoma for whom surgery is inappropriate. STEVIE was designed to assess the safety of vismodegib in a situation similar to routine practice, with a long follow-up. In this multicentre, open-label trial, adult patients with histologically confirmed locally advanced basal cell carcinoma or metastatic basal cell carcinoma were recruited from regional referral centres or specialist clinics. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and adequate organ function. Patients with locally advanced basal cell carcinoma had to have been deemed ineligible for surgery. All patients received 150 mg oral vismodegib capsules once a day on a continuous basis in 28-day cycles. The primary objective was safety (incidence of adverse events until disease progression or unacceptable toxic effects), with assessments on day 1 of each treatment cycle (28 days) by principal investigator and coinvestigators at the site. Efficacy variables were assessed as secondary endpoints. The safety evaluable population included all patients who received at least one dose of study drug. Patients with histologically confirmed basal cell carcinoma who received at least one dose of study drug were included in the efficacy analysis. An interim analysis was pre-planned after 500 patients achieved 1 year of follow-up. This trial is registered with ClinicalTrials.gov, number NCT01367665. The study is still ongoing. Between June 30, 2011, and Nov 6, 2014, we enrolled 1227 patients. At clinical cutoff (Nov 6, 2013), 499 patients (468 with locally advanced basal cell carcinoma and 31 with metastatic basal cell carcinoma) had received study drug and had the potential to be followed up for 12 months or longer. Treatment was discontinued in 400 (80

  14. Inconvenience due to travelers' diarrhea: a prospective follow-up study

    Directory of Open Access Journals (Sweden)

    Soonawala Darius

    2011-11-01

    Full Text Available Abstract Background Limited data exist documenting the degree to which travelers are inconvenienced by travelers' diarrhea (TD. We performed a prospective follow-up study at the travel clinic of Leiden University Medical Center in The Netherlands to determine the degree of inconvenience and to determine how experiencing TD affects travelers' perception. Methods Healthy adults who intended to travel to the (subtropics for less than two months were invited to take part. Participants filled out a web-based questionnaire before departure and after returning home. TD was defined as three or more unformed stools during a 24-hour period. Results 390 of 776 Eligible travelers completed both questionnaires. Participants' median age was 31 years and mean travel duration 23 days. Of 160 travelers who contracted TD (incidence proportion 41%, median duration of TD episode 2.5 days the majority (107/160, 67% could conduct their activity program as planned despite having diarrhea. However, 21% (33/160 were forced to alter their program and an additional 13% (20/160 were confined to their accommodation for one or more daylight days; 53 travelers (33% used loperamide and 14 (9% an antibiotic. Eight travelers (5% consulted a physician for the diarrheal illness. When asked about the degree of inconvenience brought on by the diarrheal illness, 39% categorized it as minor or none at all, 34% as moderate and 27% as large or severe. In those who regarded the episode of TD a major inconvenience, severity of symptoms was greater and use of treatment and necessity to alter the activity program were more common. Travelers who contracted travelers' diarrhea considered it less of a problem in retrospect than they had thought it would be before departure. Conclusion Conventional definitions of TD encompass many mild cases of TD (in our study at least a third of all cases for which treatment is unlikely to provide a significant health benefit. By measuring the degree of

  15. Inconvenience due to travelers' diarrhea: a prospective follow-up study.

    Science.gov (United States)

    Soonawala, Darius; Vlot, Jessica A; Visser, Leo G

    2011-11-20

    Limited data exist documenting the degree to which travelers are inconvenienced by travelers' diarrhea (TD). We performed a prospective follow-up study at the travel clinic of Leiden University Medical Center in The Netherlands to determine the degree of inconvenience and to determine how experiencing TD affects travelers' perception. Healthy adults who intended to travel to the (sub)tropics for less than two months were invited to take part. Participants filled out a web-based questionnaire before departure and after returning home. TD was defined as three or more unformed stools during a 24-hour period. 390 of 776 Eligible travelers completed both questionnaires. Participants' median age was 31 years and mean travel duration 23 days. Of 160 travelers who contracted TD (incidence proportion 41%, median duration of TD episode 2.5 days) the majority (107/160, 67%) could conduct their activity program as planned despite having diarrhea. However, 21% (33/160) were forced to alter their program and an additional 13% (20/160) were confined to their accommodation for one or more daylight days; 53 travelers (33%) used loperamide and 14 (9%) an antibiotic. Eight travelers (5%) consulted a physician for the diarrheal illness. When asked about the degree of inconvenience brought on by the diarrheal illness, 39% categorized it as minor or none at all, 34% as moderate and 27% as large or severe. In those who regarded the episode of TD a major inconvenience, severity of symptoms was greater and use of treatment and necessity to alter the activity program were more common. Travelers who contracted travelers' diarrhea considered it less of a problem in retrospect than they had thought it would be before departure. Conventional definitions of TD encompass many mild cases of TD (in our study at least a third of all cases) for which treatment is unlikely to provide a significant health benefit. By measuring the degree of inconvenience brought on by TD, researchers and policy makers

  16. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial.

    Science.gov (United States)

    Granel, Brigitte; Daumas, Aurélie; Jouve, Elisabeth; Harlé, Jean-Robert; Nguyen, Pierre-Sébastien; Chabannon, Christian; Colavolpe, Nathalie; Reynier, Jean-Charles; Truillet, Romain; Mallet, Stéphanie; Baiada, Antoine; Casanova, Dominique; Giraudo, Laurent; Arnaud, Laurent; Veran, Julie; Sabatier, Florence; Magalon, Guy

    2015-12-01

    In patients with systemic sclerosis (scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relieved by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune diseases. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability. We did an open-label, single arm, at one study site with 6-month follow-up among 12 female SSc patients with Cochin Hand Function Scale score >20/90. Autologous SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles. Primary outcome was the number and the severity of adverse events related to SVF-based therapy. Secondary endpoints were changes in hand disability and fibrosis, vascular manifestations, pain and quality of life from baseline to 2 and 6 months after cell therapy. All enrolled patients had surgery, and there were no dropouts or patients lost to follow-up. No severe adverse events occurred during the procedure and follow-up. Four minor adverse events were reported and resolved spontaneously. A significant improvement in hand disability and pain, Raynaud's phenomenon, finger oedema and quality of life was observed. This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population. GFRS (Groupe Francophone de Recherche sur la Sclérodermie). NCT01813279. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

  17. A Decade of GRB Follow-Up by BOOTES in Spain (2003–2013

    Directory of Open Access Journals (Sweden)

    Martin Jelínek

    2016-01-01

    Full Text Available This article covers ten years of GRB follow-ups by the Spanish BOOTES stations: 71 follow-ups providing 23 detections. Follow-ups by BOOTES-1B from 2005 to 2008 were given in a previous article and are here reviewed and updated, and additional detection data points are included as the former article merely stated their existence. The all-sky cameras CASSANDRA have not yet detected any GRB optical afterglows, but limits are reported where available.

  18. Follow up Evaluation of Air Force Blood Donors Screening Positive for Chagas Disease

    Science.gov (United States)

    2017-10-05

    59 MDW/SGVU SUBJECT: Professional Presentation Approval 31 JULY2017 Your paper, entitled Follow-up Evaluation of Air Force Blood Donors Screening...PUBLISHED OR PRESENTED: Follow-up Evaluation of Air Force Blood Donors Screening Positive for Chagas Disease 7. FUNDING RECEIVED FOR THIS STUDY? 0...PREVIOUS EDITIONS ARE OBSOLETE 50. DATE Page 3 of 3 Pages Follow-up Evaluation of Air Force Blood Donors Screening Positive for Chagas Disease

  19. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study).

    Science.gov (United States)

    Starling, Amaal J; Tepper, Stewart J; Marmura, Michael J; Shamim, Ejaz A; Robbins, Matthew S; Hindiyeh, Nada; Charles, Andrew C; Goadsby, Peter J; Lipton, Richard B; Silberstein, Stephen D; Gelfand, Amy A; Chiacchierini, Richard P; Dodick, David W

    2018-05-01

    Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a -2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (-0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of -2

  20. An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

    Directory of Open Access Journals (Sweden)

    Pandina Gahan

    2012-06-01

    Full Text Available Abstract Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7% subjects completed this study: 209 of the 279 subjects (75% in the 6-month group and 55 of the 111 subjects (50% in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (≥10% of subjects were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs were reported by 36 (9% subjects. The AE profile in this study was

  1. Dextrose and morrhuate sodium injections (prolotherapy) for knee osteoarthritis: a prospective open-label trial.

    Science.gov (United States)

    Rabago, David; Patterson, Jeffrey J; Mundt, Marlon; Zgierska, Aleksandra; Fortney, Luke; Grettie, Jessica; Kijowski, Richard

    2014-05-01

    This study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status. This was a prospective three-arm uncontrolled study with 1-year follow-up. The setting was outpatient. The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined). The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach. The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction. The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events. Prolotherapy using dextrose and morrhuate sodium injections for

  2. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up.

    Science.gov (United States)

    Carhart-Harris, R L; Bolstridge, M; Day, C M J; Rucker, J; Watts, R; Erritzoe, D E; Kaelen, M; Giribaldi, B; Bloomfield, M; Pilling, S; Rickard, J A; Forbes, B; Feilding, A; Taylor, D; Curran, H V; Nutt, D J

    2018-02-01

    Recent clinical trials are reporting marked improvements in mental health outcomes with psychedelic drug-assisted psychotherapy. Here, we report on safety and efficacy outcomes for up to 6 months in an open-label trial of psilocybin for treatment-resistant depression. Twenty patients (six females) with (mostly) severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 and 25 mg, 7 days apart) in a supportive setting. Depressive symptoms were assessed from 1 week to 6 months post-treatment, with the self-rated QIDS-SR16 as the primary outcome measure. Treatment was generally well tolerated. Relative to baseline, marked reductions in depressive symptoms were observed for the first 5 weeks post-treatment (Cohen's d = 2.2 at week 1 and 2.3 at week 5, both p psilocybin. Reductions in depressive symptoms at 5 weeks were predicted by the quality of the acute psychedelic experience. Although limited conclusions can be drawn about treatment efficacy from open-label trials, tolerability was good, effect sizes large and symptom improvements appeared rapidly after just two psilocybin treatment sessions and remained significant 6 months post-treatment in a treatment-resistant cohort. Psilocybin represents a promising paradigm for unresponsive depression that warrants further research in double-blind randomised control trials.

  3. Establishment of an inferior vena cava filter database and interventional radiology led follow-up - retrieval rates and patients lost to follow-up.

    Science.gov (United States)

    Klinken, Sven; Humphries, Charlotte; Ferguson, John

    2017-10-01

    To evaluate the rates of inferior vena cava (IVC) filter retrieval and the number of patient's lost to follow-up, before and after the establishment of an IVC filter database and interventional radiology (inserting physician) led follow-up. On the 1st of June 2012, an electronic interventional radiology database was established at our Institution. In addition, the interventional radiology team took responsibility for follow-up of IVC filters. Data were prospectively collected from the database for all patients who had an IVC filter inserted between the 1st June 2012 and the 31st May 2014. Data on patients who had an IVC filter inserted between the 1st of June 2009 to the 31st of May 2012 were retrospectively reviewed. Patient demographics, insertion indications, filter types, retrieval status, documented retrieval decisions, time in situ, trackable events and complications were obtained in the pre-database (n = 136) and post-database (n = 118) cohorts. Attempted IVC filter retrieval rates were improved from 52.9% to 72.9% (P = 0.001) following the establishment of the database. The number of patients with no documented decision (lost to follow-up) regarding their IVC filter reduced from 31 of 136 (23%) to 0 of 118 patients (P = database group (113 as compared to 137 days, P = 0.129). Following the establishment of an IVC filter database and interventional radiology led follow-up, we demonstrate a significant improvement in the attempted retrieval rates of IVC filters and the number of patient's lost to follow-up. © 2017 The Royal Australian and New Zealand College of Radiologists.

  4. Sputum smear microscopy at two months into continuation-phase: should it be done in all patients with sputum smear-positive tuberculosis?

    Directory of Open Access Journals (Sweden)

    Mohit Padamchand Gandhi

    Full Text Available BACKGROUND: The Revised National Tuberculosis Control Program (RNTCP of India recommends follow-up sputum smear examination at two months into the continuation phase of treatment. The main intent of this (mid-CP follow-up is to detect patients not responding to treatment around two-three months earlier than at the end of the treatment. However, the utility of mid-CP follow-up under programmatic conditions has been questioned. We undertook a multi-district study to determine if mid-CP follow-up is able to detect cases of treatment failures early among all types of patients with sputum smear-positive TB. METHODOLOGY: We reviewed existing records of patients with sputum smear-positive TB registered under the RNTCP in 43 districts across three states of India during a three month period in 2009. We estimated proportions of patients that could be detected as a case of treatment failure early, and assessed the impact of various policy options on laboratory workload and number needed to test to detect one case of treatment failure early. RESULTS: Of 10055 cases, mid-CP follow-up was done in 6944 (69% cases. Mid-CP follow-up could benefit 117/8015 (1.5% new and 206/2040 (10% previously-treated sputum smear-positive cases by detecting their treatment failure early. Under the current policy, 31 patients had to be tested to detect one case of treatment failure early. All cases of treatment failure would still be detected early if mid-CP follow-up were discontinued for new sputum smear-positive cases who become sputum smear-negative after the intensive-phase of treatment. This would reduce the related laboratory workload by 69% and only 10 patients would need to be tested to detect one case of treatment failure early. CONCLUSION: Discontinuation of mid-CP follow-up among new sputum smear-positive cases who become sputum smear-negative after completing the intensive-phase of treatment will reduce the laboratory workload without impacting overall early

  5. Ibrutinib, lenalidomide, and rituximab in relapsed or refractory mantle cell lymphoma (PHILEMON): a multicentre, open-label, single-arm, phase 2 trial.

    Science.gov (United States)

    Jerkeman, Mats; Eskelund, Christian Winther; Hutchings, Martin; Räty, Riikka; Wader, Karin Fahl; Laurell, Anna; Toldbod, Helle; Pedersen, Lone Bredo; Niemann, Carsten Utoft; Dahl, Christina; Kuitunen, Hanne; Geisler, Christian H; Grønbæk, Kirsten; Kolstad, Arne

    2018-03-01

    Regimens based on ibrutinib alone and lenalidomide and rituximab in combination show high activity in patients with relapsed or refractory mantle cell lymphoma. We hypothesised that the combination of all three drugs would improve efficacy compared with previously published data on either regimen alone. In this multicentre, open-label, single-arm, phase 2 trial, we enrolled patients aged 18 years or older with relapsed or refractory mantle cell lymphoma who had previously been treated with at least one rituximab-containing regimen, an Eastern Cooperative Oncology Group performance status score of 0-3, and at least one site of measurable disease, and who met criteria for several laboratory-assessed parameters. Treatment was divided into an induction phase of 12 cycles of 28 days with all three drugs and a maintenance phase with ibrutinib and rituximab only (cycle duration 56 days), given until disease progression or unacceptable toxicity. In the induction phase, patients received intravenous (375 mg/m 2 ) or subcutaneous (1400 mg) rituximab once a week during cycle 1 and then once every 8 weeks. Oral ibrutinib (560 mg once a day) was given to patients every day in the cycle, whereas oral lenalidomide (15 mg once a day) was given on days 1-21. The primary endpoint was overall response assessed in the intention-to-treat population according to Lugano criteria. Safety analysis included all patients who received the treatment, irrespective of eligibility or duration of treatment. The trial is ongoing, but is no longer accruing patients, and is registered with ClinicalTrials.gov, number NCT02460276. Between April 30, 2015, and June 1, 2016, we enrolled 50 patients with relapsed or refractory mantle cell lymphoma at ten centres in Sweden, Finland, Norway, and Denmark. At a median follow-up of 17·8 months (IQR 14·7-20·9), 38 (76%, 95% CI 63-86) patients had an overall response, including 28 (56%, 42-69) patients who had a complete response and ten (20%, 11-33) who had a

  6. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial.

    Science.gov (United States)

    O'Brien, Susan; Furman, Richard R; Coutre, Steven E; Sharman, Jeff P; Burger, Jan A; Blum, Kristie A; Grant, Barbara; Richards, Donald A; Coleman, Morton; Wierda, William G; Jones, Jeffrey A; Zhao, Weiqiang; Heerema, Nyla A; Johnson, Amy J; Izumi, Raquel; Hamdy, Ahmed; Chang, Betty Y; Graef, Thorsten; Clow, Fong; Buggy, Joseph J; James, Danelle F; Byrd, John C

    2014-01-01

    Chemoimmunotherapy has led to improved numbers of patients achieving disease response, and longer overall survival in young patients with chronic lymphocytic leukaemia; however, its application in elderly patients has been restricted by substantial myelosuppression and infection. We aimed to assess safety and activity of ibrutinib, an orally administered covalent inhibitor of Bruton tyrosine kinase (BTK), in treatment-naive patients aged 65 years and older with chronic lymphocytic leukaemia. In our open-label phase 1b/2 trial, we enrolled previously untreated patients at clinical sites in the USA. Eligible patients were aged at least 65 years, and had symptomatic chronic lymphocytic leukaemia or small lymphocytic lymphoma requiring therapy. Patients received 28 day cycles of once-daily ibrutinib 420 mg or ibrutinib 840 mg. The 840 mg dose was discontinued after enrolment had begun because comparable activity of the doses has been shown. The primary endpoint was the safety of the dose-fixed regimen in terms of frequency and severity of adverse events for all patients who received treatment. This study is registered with ClinicalTrials.gov, number NCT01105247. Between May 20, 2010, and Dec 18, 2012, we enrolled 29 patients with chronic lymphocytic leukaemia and two patients with small lymphocytic lymphoma. Median age was 71 years (range 65-84), and 23 (74%) patients were at least 70 years old. Toxicity was mainly of mild-to-moderate severity (grade 1-2). 21 (68%) patients had diarrhoea (grade 1 in 14 [45%] patients, grade 2 in three [10%] patients, and grade 3 in four [13%] patients). 15 (48%) patients developed nausea (grade 1 in 12 [39%] patients and grade 2 in three [10%] patients). Ten (32%) patients developed fatigue (grade 1 in five [16%] patients, grade 2 in four [13%] patients, and grade 3 in one [3%] patient). Three (10%) patients developed grade 3 infections, although no grade 4 or 5 infections occurred. One patient developed grade 3 neutropenia, and one

  7. A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease

    Directory of Open Access Journals (Sweden)

    Friedman NJ

    2016-05-01

    Full Text Available Neil J Friedman,1 Karla Butron,2 Nora Robledo,2 James Loudin,3 Stephanie N Baba,3 Arturo Chayet2 1Department of Ophthalmology, Stanford University, Mid-Peninsula Ophthalmology Medical Group, Palo Alto, CA, USA; 2Codet Vision Institute, Tijuana, Mexico; 3Oculeve, Inc., South San Francisco, CA, USA Background: Dry eye disease (DED, a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED. Methods: This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed. Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations. Results: Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related were reported. Intraocular pressure remained

  8. Nimotuzumab plus chemotherapy versus chemotherapy alone in advanced non-small-cell lung cancer: a multicenter, randomized, open-label Phase II study

    Directory of Open Access Journals (Sweden)

    Babu KG

    2014-06-01

    Full Text Available K Govind Babu,1 Kumar Prabhash,2 Ashok K Vaid,3 Bhawna Sirohi,3 Ravi B Diwakar,4 Raghunadha Rao,5 Madhuchanda Kar,6 Hemant Malhotra,7 Shona Nag,8 Chanchal Goswami,9 Vinod Raina,10 Ravi Mohan111Kidwai Memorial Institute of Oncology, Bangalore, 2Tata Memorial Hospital, Mumbai, 3Artemis Health Institute, Delhi, 4Bangalore Institute of Oncology, Bangalore, 5Nizam Institute of Medical Sciences, Hyderabad, 6B R Singh Hospital, Kolkata, 7Birla Cancer Centre, Jaipur, 8Jehangir Hospital, Pune, 9B P Poddar Hospital and Medical Research Ltd, Kolkata, 10Institute Rotary Cancer Hospital, New Delhi, 11King George Hospital, Visakhapatnam, IndiaBackground: The purpose of this study was to evaluate the safety and efficacy of nimotuzumab in combination with chemotherapy (docetaxel and carboplatin versus chemotherapy alone in patients with stage IIIB/IV non-small-cell lung cancer.Methods: This multicenter, open-label, Phase II study randomized 110 patients to receive nimotuzumab plus chemotherapy (nimotuzumab group or chemotherapy alone (control group, and comprised concomitant, maintenance, and follow-up phases. Nimotuzumab 200 mg was administered once weekly for 13 weeks during the first two phases with four cycles of chemotherapy and docetaxel 75 mg/m2 and carboplatin (area under the curve 5 mg/mL*min every 3 weeks for a maximum of four cycles during the concomitant phase. The primary endpoint was objective response rate (sum of complete response and partial response. Secondary endpoints, ie, overall survival and progression-free survival, were estimated using the Kaplan–Meier method. Efficacy was evaluated on the intent-to-treat and efficacy-evaluable sets. Safety was assessed from adverse event and serious adverse event data.Results: The objective response rate was significantly higher in the nimotuzumab group than in the control group in the intent-to-treat population (54% versus 34.5%; P=0.04. A complete response and partial response were achieved in 3

  9. A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma

    International Nuclear Information System (INIS)

    Schnitzbauer, Andreas A; Adam, Rene; Bechstein, Wolf O; Becker, Thomas; Beckebaum, Susanne; Chazouillères, Olivier; Cillo, Umberto; Colledan, Michele; Fändrich, Fred; Gugenheim, Jean; Hauss, Johann P; Zuelke, Carl; Heise, Michael; Hidalgo, Ernest; Jamieson, Neville; Königsrainer, Alfred; Lamby, Philipp E; Lerut, Jan P; Mäkisalo, Heikki; Margreiter, Raimund; Mazzaferro, Vincenzo; Mutzbauer, Ingrid; Graeb, Christian; Otto, Gerd; Pageaux, Georges-Philippe; Pinna, Antonio D; Pirenne, Jacques; Rizell, Magnus; Rossi, Giorgio; Rostaing, Lionel; Roy, Andre; Turrion, Victor Sanchez; Schmidt, Jan; Rochon, Justine; Troisi, Roberto I; Hoek, Bart van; Valente, Umberto; Wolf, Philippe; Wolters, Heiner; Mirza, Darius F; Scholz, Tim; Steininger, Rudolf; Soderdahl, Gunnar; Strasser, Simone I; Bilbao, Itxarone; Jauch, Karl-Walter; Neuhaus, Peter; Schlitt, Hans J; Geissler, Edward K; Burra, Patrizia; Jong, Koert P de; Duvoux, Christophe; Kneteman, Norman M

    2010-01-01

    The potential anti-cancer effects of mammalian target of rapamycin (mTOR) inhibitors are being intensively studied. To date, however, few randomised clinical trials (RCT) have been performed to demonstrate anti-neoplastic effects in the pure oncology setting, and at present, no oncology endpoint-directed RCT has been reported in the high-malignancy risk population of immunosuppressed transplant recipients. Interestingly, since mTOR inhibitors have both immunosuppressive and anti-cancer effects, they have the potential to simultaneously protect against immunologic graft loss and tumour development. Therefore, we designed a prospective RCT to determine if the mTOR inhibitor sirolimus can improve hepatocellular carcinoma (HCC)-free patient survival in liver transplant (LT) recipients with a pre-transplant diagnosis of HCC. The study is an open-labelled, randomised, RCT comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing LT for HCC. Patients with a histologically confirmed HCC diagnosis are randomised into 2 groups within 4-6 weeks after LT; one arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol and the second arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol for the first 4-6 weeks, at which time sirolimus is initiated. A 2 1/2 -year recruitment phase is planned with a 5-year follow-up, testing HCC-free survival as the primary endpoint. Our hypothesis is that sirolimus use in the second arm of the study will improve HCC-free survival. The study is a non-commercial investigator-initiated trial (IIT) sponsored by the University Hospital Regensburg and is endorsed by the European Liver and Intestine Transplant Association; 13 countries within Europe, Canada and Australia are participating. If our hypothesis is correct that mTOR inhibition can reduce HCC tumour growth while simultaneously providing immunosuppression to protect the liver allograft from

  10. Dabrafenib plus trametinib in patients with previously untreated BRAFV600E-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial.

    Science.gov (United States)

    Planchard, David; Smit, Egbert F; Groen, Harry J M; Mazieres, Julien; Besse, Benjamin; Helland, Åslaug; Giannone, Vanessa; D'Amelio, Anthony M; Zhang, Pingkuan; Mookerjee, Bijoyesh; Johnson, Bruce E

    2017-10-01

    BRAF V600E mutation occurs in 1-2% of lung adenocarcinomas and acts as an oncogenic driver. Dabrafenib, alone or combined with trametinib, has shown substantial antitumour activity in patients with previously treated BRAF V600E -mutant metastatic non-small-cell lung cancer (NSCLC). We aimed to assess the activity and safety of dabrafenib plus trametinib treatment in previously untreated patients with BRAF V600E -mutant metastatic NSCLC. In this phase 2, sequentially enrolled, multicohort, multicentre, non-randomised, open-label study, adults (≥18 years of age) with previously untreated metastatic BRAF V600E -mutant NSCLC were enrolled into cohort C from 19 centres in eight countries within North America, Europe, and Asia. Patients received oral dabrafenib 150 mg twice per day plus oral trametinib 2 mg once per day until disease progression, unacceptable adverse events, consent withdrawal, or death. The primary endpoint was investigator-assessed overall response, defined as the percentage of patients who achieved a confirmed complete response or partial response per Response Evaluation Criteria In Solid Tumors version 1.1. The primary and safety analyses were by intention to treat in the protocol-defined population (previously untreated patients). The study is ongoing, but no longer recruiting patients. This trial is registered with ClinicalTrials.gov, number NCT01336634. Between April 16, 2014, and Dec 28, 2015, 36 patients were enrolled and treated with first-line dabrafenib plus trametinib. Median follow-up was 15·9 months (IQR 7·8-22·0) at the data cutoff (April 28, 2017). The proportion of patients with investigator-assessed confirmed overall response was 23 (64%, 95% CI 46-79), with two (6%) patients achieving a complete response and 21 (58%) a partial response. All patients had one or more adverse event of any grade, and 25 (69%) had one or more grade 3 or 4 event. The most common (occurring in more than two patients) grade 3 or 4 adverse events were

  11. A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    Roy Andre

    2010-05-01

    Full Text Available Abstract Background The potential anti-cancer effects of mammalian target of rapamycin (mTOR inhibitors are being intensively studied. To date, however, few randomised clinical trials (RCT have been performed to demonstrate anti-neoplastic effects in the pure oncology setting, and at present, no oncology endpoint-directed RCT has been reported in the high-malignancy risk population of immunosuppressed transplant recipients. Interestingly, since mTOR inhibitors have both immunosuppressive and anti-cancer effects, they have the potential to simultaneously protect against immunologic graft loss and tumour development. Therefore, we designed a prospective RCT to determine if the mTOR inhibitor sirolimus can improve hepatocellular carcinoma (HCC-free patient survival in liver transplant (LT recipients with a pre-transplant diagnosis of HCC. Methods/Design The study is an open-labelled, randomised, RCT comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing LT for HCC. Patients with a histologically confirmed HCC diagnosis are randomised into 2 groups within 4-6 weeks after LT; one arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol and the second arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol for the first 4-6 weeks, at which time sirolimus is initiated. A 21/2 -year recruitment phase is planned with a 5-year follow-up, testing HCC-free survival as the primary endpoint. Our hypothesis is that sirolimus use in the second arm of the study will improve HCC-free survival. The study is a non-commercial investigator-initiated trial (IIT sponsored by the University Hospital Regensburg and is endorsed by the European Liver and Intestine Transplant Association; 13 countries within Europe, Canada and Australia are participating. Discussion If our hypothesis is correct that mTOR inhibition can reduce HCC tumour growth while simultaneously

  12. The positive effect of posterolateral lumbar spinal fusion is preserved at long-term follow-up: a RCT with 11-13 year follow-up

    DEFF Research Database (Denmark)

    Andersen, Thomas; Videbaek, Tina S; Hansen, Ebbe S

    2008-01-01

    outcome parameter. RESULTS: Follow-up was 83% of the original study population (107 patients). Average follow-up time was 12 years (range 11-13 years). DPQ-scores were significantly lower than preoperatively in both groups (P ... had retired due to low back pain had poorer outcome than patients retired for other reasons, best outcome was seen in patients still at work (P = 0.01 or less in all questionnaires, except SF-36 MCS P = 0.08). DISCUSSION: Improvement in functional outcome is preserved for 10 or more years after...

  13. Follow-up care of young childhood cancer survivors: attendance and parental involvement.

    Science.gov (United States)

    Vetsch, Janine; Rueegg, Corina S; Mader, Luzius; Bergstraesser, Eva; Rischewski, Johannes; Kuehni, Claudia E; Michel, Gisela

    2016-07-01

    Despite recommendations, only a proportion of long-term childhood cancer survivors attend follow-up care. We aimed to (1) describe the follow-up attendance of young survivors aged 11-17 years; (2) describe the parental involvement in follow-up, and (3) investigate predictors of follow-up attendance and parental involvement. As part of the Swiss Childhood Cancer Survivor Study, a follow-up questionnaire was sent to parents of childhood cancer survivors aged 11-17 years. We assessed follow-up attendance of the child, parents' involvement in follow-up, illness perception (Brief IPQ), and sociodemographic data. Clinical data was available from the Swiss Childhood Cancer Registry. Of 309 eligible parents, 189 responded (67 %; mean time since diagnosis 11.3 years, range 6.8-17.2) and 75 % (n = 141) reported that their child still attended follow-up. Of these, 83 % (n = 117) reported ≥1 visit per year and 17 % (n = 23) reported parents (92 %) reported being involved in follow-up (n = 130). In multivariable and Cox regression analyses, longer time since diagnosis (p = 0.025) and lower perceived treatment control (assessed by IPQ4: how much parents thought follow-up can help with late effects; p = 0.009) were associated with non-attendance. Parents' overall information needs was significantly associated with parental involvement in the multivariable model (p = 0.041). Educating survivors and their parents on the importance and effectiveness of follow-up care might increase attendance in the longer term.

  14. Structured nursing follow-up: does it help in diabetes care?

    Science.gov (United States)

    Shani, Michal; Nakar, Sasson; Lustman, Alex; Lahad, Amnon; Vinker, Shlomo

    2014-01-01

    In 1995 Clalit Health Services introduced a structured follow-up schedule, by primary care nurses, of diabetic patients. This was supplementary care, given in addition to the family physician's follow-up care. This article aims to describe the performance of diabetes follow-up and diabetes control in patients with additional structured nursing follow-up care, compared to those patients followed only by their family physician. We randomly selected 2,024 type 2 diabetic subjects aged 40-76 years. For each calendar year, from 2005-2007, patients who were "under physician follow-up only" were compared to those who received additional structured nursing follow-up care. Complete diabetes follow-up parameters including: HbA1c, LDL cholesterol, microalbumin, blood pressure measurements and fundus examination. The average age of study participants was 60.7 years, 52% were females and 38% were from low socioeconomic status (SES). In 2005, 39.5% of the diabetic patients received structured nursing follow-up, and the comparable figures for 2006 and 2007 were 42.1% 49.6%, respectively. The intervention subjects tended to be older, from lower SES, suffered from more chronic diseases and visited their family physician more frequently than the control patients. Patients in the study group were more likely to perform a complete diabetes follow-up plan: 52.8% vs. 21.5% (2005; p nursing follow-up care were more likely to perform complete diabetes follow-up protocol. Our results reinforce the importance of teamwork in diabetic care. Further study is required to identify strategies for channeling the use of the limited resources to the patients who stand to benefit the most.

  15. Profile and pattern of follow-ups of psychiatry outpatients at Christian Medical College, Ludhiana

    Directory of Open Access Journals (Sweden)

    Mamta Singla

    2015-01-01

    Full Text Available Context: As psychiatric illness requires long-term treatment, some patients are lost to follow-up. Aims: The present study aimed to find the follow-up pattern of psychiatric patients attending psychiatry outpatient department (OPD and to determine the correlation of follow-up with socio-demographic profile and diagnosis, if any. Settings and Design: This study was a retrospective data analysis study carried out at the OPD of Psychiatry, Christian Medical College and Hospital, Ludhiana. Subjects and Methods: New cases attending the OPD from April 2010 to March 2011 were included in this study. The data were scrutinized 1 year after the initial assessment. Socio-demographic data, diagnosis and follow-up information were obtained from the files. The collected data were statistically analyzed. Statistical Analysis Used: Chi-square and P value. Results: 53.1% of the patients dropped out after first visit, 29.4% patients had 1-3 follow-up, 14.9% had 4-10 follow-ups and only 2.6% had more than 10 follow-ups. Correlation between follow-up and various socio-demographic variables such as age, gender, place of living or distance from hospital, occupation, religion and marital status was not statistically significant. It was, however, seen that cognitive disorders, conversion disorder, mental retardation, and patients in which diagnosis was deferred, had more dropout rate after first visit. Conclusions: In our study 53.1% of the patients did not attend follow-up at all and only 2.6% had more than 10 follow ups. Correlation between follow-up and various socio-demographic variables was not statistically significant. Patients in which diagnosis was deferred had more drop out rate than patients who had a diagnosis and the difference was statistically significant.

  16. An open-label pilot trial of alpha-lipoic acid for weight loss in patients with schizophrenia without diabetes.

    Science.gov (United States)

    Ratliff, Joseph C; Palmese, Laura B; Reutenauer, Erin L; Tek, Cenk

    2015-01-01

    A possible mechanism of antipsychotic-induced weight gain is activation of hypothalamic monophosphate-dependent kinase (AMPK) mediated by histamine 1 receptors. Alpha-lipoic acid (ALA), a potent antioxidant, counteracts this effect and may be helpful in reducing weight for patients taking antipsychotics. The objective of this open-label study was to assess the efficacy of ALA (1,200 mg) on twelve non-diabetic schizophrenia patients over ten weeks. Participants lost significant weight during the intervention (-2.2 kg±2.5 kg). ALA was well tolerated and was particularly effective for individuals taking strongly antihistaminic antipsychotics (-2.9 kg±2.6 kg vs. -0.5 kg±1.0 kg). NCT01355952.

  17. An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder.

    Science.gov (United States)

    Kent, Justine M; Hough, David; Singh, Jaskaran; Karcher, Keith; Pandina, Gahan

    2013-12-01

    The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders. In this 6 month (26 week) open-label extension (OLE) study, patients (5-17 years of age, who completed the previous fixed-dose, 6 week, double-blind [DB] phase) were flexibly dosed with risperidone based on body weight. The maximum allowed dose was 1.25 mg/day for those weighing 20 to autistic, psychiatric, and behavioral disorders. Patients experienced some additional improvement in irritability and related behaviors. This phase-4 study is registered at ClinicalTrials.gov (NCT00576732).

  18. Evaluation of results and radiologic follow-up in detachable balloon occlusion therapy of the internal carotid artery aneurysms

    International Nuclear Information System (INIS)

    Chung, Sun Yang; Kim, Dong Ik; Lee, Kyu Chang; Huh, Seung Kon; Yoon, Pyeong Ho; Choi, Jin Young; Kim, Dong Jun

    1999-01-01

    The author has studied the clinical results of CT and MR findings of proximal carotid artery occlusion using detachable balloons in the treatement of unclippable internal carotid (IC) aneurysms. From 1987 to 1995, twenty-eight patients with IC aneurysms were treated by proximal artery occlusion with detachable balloons. Of these patients, 4 had aneurysms arising from the supraclinoid portion of the IC artery, 23 had aneuryms arising from cavernous portion of the IC artery, and one had aneurysm arising from cervical portion of the IC artery. Of the 28 patients, 7 patients without CT or MR examinations were excluded in this study. The mean follow-up period was 18.6 months. The causes of aneurysm formation were spontaneous in 17 cases and traumatic in 4 cases. Of 20 patients with aneurysms arising from supraclinoid and cavernous portion of the IC artery, 16 patients (80%) had cranial nerve symptoms by mass effect. Five patients had epistaxis (3 patient), carotid cavernous fistula (1 patient) or subarachnoid hemorrhage (1 patient) due to aneurysm rupture. Two patients, each with aneuryms arising from supraclinoid and cervical portion of carotid artery had 9th and 12th cranial nerve symptom. There were three instances of complication after permanent occlusion; two patients had subarachnoid and intracerebral hemorrhage by aneurysm rupture and expired. One patient had ischemia of posterior cerebral artery teritorry after one day. Delayed ischemic event did not occur during the follow-up period. All aneurysms of the carotid artery below the level of ophthalmic artery presented radiographic proof of complete thrombosis within two months. However, complete thrombosis of aneurysm was considerably delayed in two aneurysms arising from the supraclinoid portion of the carotid artery. In long-term follow-up study, completely thrombosed aneurysms decreased in size slowly. But incompletely thrombosed aneurysms did not decrease in size for a long time and began to contract after

  19. Evaluation of results and radiologic follow-up in detachable balloon occlusion therapy of the internal carotid artery aneurysms

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Sun Yang; Kim, Dong Ik; Lee, Kyu Chang; Huh, Seung Kon; Yoon, Pyeong Ho; Choi, Jin Young; Kim, Dong Jun [Yonsei Univ. College of Medicine, Seoul (Korea, Republic of)

    1999-06-01

    The author has studied the clinical results of CT and MR findings of proximal carotid artery occlusion using detachable balloons in the treatement of unclippable internal carotid (IC) aneurysms. From 1987 to 1995, twenty-eight patients with IC aneurysms were treated by proximal artery occlusion with detachable balloons. Of these patients, 4 had aneurysms arising from the supraclinoid portion of the IC artery, 23 had aneuryms arising from cavernous portion of the IC artery, and one had aneurysm arising from cervical portion of the IC artery. Of the 28 patients, 7 patients without CT or MR examinations were excluded in this study. The mean follow-up period was 18.6 months. The causes of aneurysm formation were spontaneous in 17 cases and traumatic in 4 cases. Of 20 patients with aneurysms arising from supraclinoid and cavernous portion of the IC artery, 16 patients (80%) had cranial nerve symptoms by mass effect. Five patients had epistaxis (3 patient), carotid cavernous fistula (1 patient) or subarachnoid hemorrhage (1 patient) due to aneurysm rupture. Two patients, each with aneuryms arising from supraclinoid and cervical portion of carotid artery had 9th and 12th cranial nerve symptom. There were three instances of complication after permanent occlusion; two patients had subarachnoid and intracerebral hemorrhage by aneurysm rupture and expired. One patient had ischemia of posterior cerebral artery teritorry after one day. Delayed ischemic event did not occur during the follow-up period. All aneurysms of the carotid artery below the level of ophthalmic artery presented radiographic proof of complete thrombosis within two months. However, complete thrombosis of aneurysm was considerably delayed in two aneurysms arising from the supraclinoid portion of the carotid artery. In long-term follow-up study, completely thrombosed aneurysms decreased in size slowly. But incompletely thrombosed aneurysms did not decrease in size for a long time and began to contract after

  20. Cardiac abnormalities in a follow-up study on carriers of Duchenne and Becker muscular dystrophy

    NARCIS (Netherlands)

    van Westrum, S. M. Schade; Hoogerwaard, E. M.; Dekker, L.; Standaar, T. S.; Bakker, E.; Ippel, P. F.; Oosterwijk, J. C.; Majoor-Krakauer, D. F.; van Essen, A. J.; Leschot, N. J.; Wilde, A. A. M.; de Haan, R. J.; de Visser, M.; van der Kooi, A. J.

    Objectives: Cardiac involvement has been reported in carriers of dystrophin mutations giving rise to Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD). The progress of these abnormalities during long-term follow-up is unknown. We describe the long-term follow-up of dilated

  1. Cardiac abnormalities in a follow-up study on carriers of Duchenne and Becker muscular dystrophy

    NARCIS (Netherlands)

    Schade van Westrum, S. M.; Hoogerwaard, E. M.; Dekker, L.; Standaar, T. S.; Bakker, E.; Ippel, P. F.; Oosterwijk, J. C.; Majoor-Krakauer, D. F.; van Essen, A. J.; Leschot, N. J.; Wilde, A. A. M.; de Haan, R. J.; de Visser, M.; van der Kooi, A. J.

    2011-01-01

    Objectives: Cardiac involvement has been reported in carriers of dystrophin mutations giving rise to Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD). The progress of these abnormalities during long-term follow-up is unknown. We describe the long-term follow-up of dilated

  2. Follow-up methods for retrospective cohort studies in New Zealand.

    Science.gov (United States)

    Fawcett, Jackie; Garrett, Nick; Bates, Michael N

    2002-01-01

    To define a general methodology for maximising the success of follow-up processes for retrospective cohort studies in New Zealand, and to illustrate an approach to developing country-specific follow-up methodologies. We recently conducted a cohort study of mortality and cancer incidence in New Zealand professional fire fighters. A number of methods were used to trace vital status, including matching with records of the New Zealand Health Information Service (NZHIS), pension records of Work and Income New Zealand (WINZ), and electronic electoral rolls. Non-electronic methods included use of paper electoral rolls and the records of the Registrar of Births Deaths and Marriages. 95% of the theoretical person-years of follow-up of the cohort were traced using these methods. In terms of numbers of cohort members traced to end of follow-up, the most useful tracing methods were fire fighter employment records, the NZHIS, WINZ, and the electronic electoral rolls. The follow-up process used for the cohort study was highly successful. On the basis of this experience, we propose a generic, but flexible, model for follow-up of retrospective cohort studies in New Zealand. Similar models could be constructed for other countries. Successful follow-up of cohort studies is possible in New Zealand using established methods. This should encourage the use of cohort studies for the investigation of epidemiological issues. Similar models for follow-up processes could be constructed for other countries.

  3. Colorectal cancer incidence in path_MLH1 carriers subjected to different follow-up protocols

    DEFF Research Database (Denmark)

    Seppälä, Toni; Pylvänäinen, Kirsi; Evans, Dafydd Gareth

    2017-01-01

    We have previously reported a high incidence of colorectal cancer (CRC) in carriers of pathogenic MLH1 variants (path_MLH1) despite follow-up with colonoscopy including polypectomy.......We have previously reported a high incidence of colorectal cancer (CRC) in carriers of pathogenic MLH1 variants (path_MLH1) despite follow-up with colonoscopy including polypectomy....

  4. Hearing screening follow-up return rate in a very low birth weight ...

    African Journals Online (AJOL)

    These may involve parental education and counselling, as well as involvement of nursing staff and medical professionals in implementation of EHDI programmes. It may be possible to improve followup by aligning follow-up screening with the day of neonatal follow-up clinics in provincial hospitals where such services are ...

  5. Socializing Intellectual Talk: A Case Study of Instructor Follow-Up Statements in Classroom Discourse

    Science.gov (United States)

    Parsons, Caroline S.

    2017-01-01

    By analyzing the audio recording and transcription of classroom discourse, this case study focused on the ways in which the instructor used follow-up statements to socialize students into intellectual talk. Four relevant categories of follow-up statements emerged: (a) revoicing, (b) contextualization, (c) parallel elaboration, and (d) assistive…

  6. Loss to follow-up in an international, multicentre observational study

    DEFF Research Database (Denmark)

    Mocroft, A; Kirk, O; Aldins, P

    2008-01-01

    OBJECTIVE: The aim of this work was to assess loss to follow-up (LTFU) in EuroSIDA, an international multicentre observational cohort study. METHODS: LTFU was defined as no follow-up visit, CD4 cell count measurement or viral load measurement after 1 January 2006. Poisson regression was used...

  7. Anxiety and depression after prostate cancer diagnosis and treatment: 5-year follow-up

    NARCIS (Netherlands)

    Korfage, I. J.; Essink-Bot, M.-L.; Janssens, A. C. J. W.; Schröder, F. H.; de Koning, H. J.

    2006-01-01

    To document anxiety and depression from pretreatment till 5-year follow-up in 299 men with localized prostate cancer. To assess, if baseline scores were predictive for anxiety and depression at 1-year follow-up. Respondents completed four assessments (pretreatment, at 6 and 12 months, and at 5-year

  8. Breast cancer follow-up: from the perspective of health professionals and patients

    NARCIS (Netherlands)

    Kwast, A.B.G.; Drossaert, Constance H.C.; Siesling, Sabine

    2013-01-01

    Increased breast cancer incidence and better survival have raised the number of patients requiring follow-up care. Despite guidelines, there is controversy about appropriate breast cancer follow-up. Therefore, semi-structured interviews were conducted in two hospitals with 23 patients and 18 health

  9. Patient's needs and preferences in routine follow-up after treatment for breast cancer

    NARCIS (Netherlands)

    de Bock, GH; Bonnema, J; Zwaan, RE; de Velde, CJH; Kievit, J; Stiggelbout, AM

    2004-01-01

    The purpose of the study was to analyse the needs of women who participated in a routine follow-up programme after treatment for primary breast cancer. A cross-sectional survey was conducted using a postal questionnaire among women without any sign of relapse during the routine follow-up period. The

  10. Methodological guide for the follow-up and elaboration of performance assessments of a methanization plant

    International Nuclear Information System (INIS)

    Bastide, Guillaume

    2014-06-01

    This guide aims at giving indications required for a good implementation of an exploitation follow-up of a methanization plant. More precisely, it aims at foreseeing equipment necessary to the follow-up of installation construction, at preparing the operator to the follow-up and command of his installation, at elaborating operation assessments and performance interpretations, at proposing solutions and/or improvements. The described follow-up process can be applied to all the process stages (from receipt to by-product valorization), and addresses technical as well as economic aspects. Thus, four types of assessments are made: technical, energetic, environmental, and social-economic. This guide comprises five parts: a presentation of follow-up objectives (information to be looked for, benefits and drawbacks, follow-up level to be implemented), the follow-up methodology, follow-up assessments (what they are and how to elaborate them), practical sheets (practical presentation of techniques, typical Excel spreadsheets), and a glossary which explains the main technical terms

  11. Towards increasing the utility of follow-up in Canadian EIA

    International Nuclear Information System (INIS)

    Noble, Bram; Storey, Keith

    2005-01-01

    The importance of follow-up in the EIA process is clearly recognized in the Canadian Environmental Assessment Act (Act) in which, where it is considered appropriate, the responsible authority for a project will design a follow-up program and ensure its implementation. The Act is also explicit in recommending that the results of follow-up programs be used to improve the quality of environmental assessments (EAs). The purpose of this paper is to examine whether the specific requirements for follow-up under the Act in fact provide the best opportunity for such quality improvements. The definition of follow-up under the Act requires the verification of the accuracy of the environmental assessment and determination of the effectiveness of measures taken to mitigate the adverse environmental effects of a project. We argue that the Act, generally, and the requirements for follow-up specifically, adopts a negative perspective towards project effects by focusing on the mitigation of adverse effects and discourages the follow-up of important social or economic effects which are independent of project-related changes to the biophysical environment. Secondly, we argue that verification of accuracy places an unwarranted emphasis on 'what was expected' rather than on 'what was wanted' in terms of environmental outcomes. Using examples from Canadian experience, we illustrate the limitations of the current approach to follow-up and suggest that greater utility would be achieved by focusing on whether the environmental objectives of the project in question have been achieved

  12. Follow-up, treatment, and reinfection rates among asymptomatic Chlamydia trachomatis cases in general practice

    NARCIS (Netherlands)

    Van Valkengoed, Irene G.M.; Morré, Servaas A.; Van Den Brule, Adriaan J.C.; Meijer, Chris J.L.M.; Bouter, Lex M.; Van Eijk, Jacques Th M.; Boeke, A. Joan P.

    2002-01-01

    Background: Adequate treatment and follow-up of patients is essential to the success of a screening programme for Chlamydia trachomatis. There has been a lack of data on follow-up, confirmation of infections, and reinfection rates among asymptomatic patients in general practice. Aim: To study the

  13. Follow-up, treatment, and reinfection rates among asymptomatic Chlamydia trachomatis cases in general practice

    NARCIS (Netherlands)

    Van Valkengoed, Irene G.M.; Morré, Servaas A.; Van Den Brule, Adriaan J.C.; Meijer, Chris J.L.M.; Bouter, Lex M.; Van Eijk, Jacques Th M.; Boeke, A. Joan P.

    2002-01-01

    BACKGROUND: Adequate treatment and follow-up of patients is essential to the success of a screening programme for Chlamydia trachomatis. There has been a lack of data on follow-up, confirmation of infections, and reinfection rates among asymptomatic patients in general practice. AIM: 7b study the

  14. Follow-up, treatment, and reinfection rates among asymptomatic chlamydia trachomatis cases in general practice

    NARCIS (Netherlands)

    van Valkengoed, Irene G. M.; Morré, Servaas A.; van den Brule, Adriaan J. C.; Meijer, Chris J. L. M.; Bouter, Lex M.; van Eijk, Jacques Th M.; Boeke, A. Joan P.

    2002-01-01

    BACKGROUND: Adequate treatment and follow-up of patients is essential to the success of a screening programme for Chlamydia trachomatis. There has been a lack of data on follow-up, confirmation of infections, and reinfection rates among asymptomatic patients in general practice. AIM: 7b study the

  15. Initial non-participation and loss to follow-up in a Danish youth cohort

    DEFF Research Database (Denmark)

    Winding, Trine Nøhr; Andersen, Johan H; Labriola, Merete

    2014-01-01

    BACKGROUND: Initial non-participation and loss to follow-up in the Danish youth cohort Vestliv could introduce selection bias of the measured risk estimates. OBJECTIVE: To investigate the impact of initial non-participation and loss to follow-up on the validity of descriptive measures and selected...

  16. Oral squamous cell carcinoma and a clinically negative neck : the value of follow-up

    NARCIS (Netherlands)

    Wensing, Bart M; Merkx, Matthias A W; Krabbe, Paul F M; Marres, Henri A M; Van den Hoogen, Frank J A

    2011-01-01

    BACKGROUND: In squamous cell carcinoma of the oral cavity (SCCOC), regular follow-up comprises 5 years of prescheduled visits, irrespective of tumor stage/classification and/or treatment. We analyzed our standard treatment and follow-up protocol in patients with a preoperative clinically negative

  17. 48 CFR 2427.305-2 - Follow-up by contractor.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Follow-up by contractor....305-2 Follow-up by contractor. (b) Contractor reports. Contractors shall complete and submit to the... Contracting Officer shall send the form to those contractors whose contract work may have required the...

  18. Long-Term Follow-up After Embolization of Pulmonary Arteriovenous Malformations with Detachable Silicone Balloons

    DEFF Research Database (Denmark)

    Andersen, Poul Erik; Kjeldsen, Anette D

    2008-01-01

    ) with pulmonary angiography. Fifty-four percent of the balloons were deflated at latest radiographic chest film follow-up, but at pulmonary angiographic follow-up all embolized malformations were without flow irrespective of whether or not the balloons were visible. Detachable silicone balloons are not available...

  19. Risk of Future Suicide Attempts in Adolescent Psychiatric Inpatients at 18-Month Follow-Up.

    Science.gov (United States)

    Brinkman-Sull, David C.; Overholser, James C.; Silverman, Eden

    2000-01-01

    Investigates potential predictors of suicidal behavior in adolescent psychiatric patients (N=60) during an 18-month follow-up period. Follow-up suicidality was most strongly predicted by high intake levels of hopelessness, and an increase in or persistent problems with depression. Proposes a model in which the impact of family functioning on…

  20. Infantile Amnesia across the Years: A 2-Year Follow-Up of Children's Earliest Memories

    Science.gov (United States)

    Peterson, Carole; Warren, Kelly L.; Short, Megan M.

    2011-01-01

    Although infantile amnesia has been investigated for many years in adults, only recently has it been investigated in children. This study was a 2-year follow-up and extension of an earlier study. Children (4-13 years old) were asked initially and 2 years later for their earliest 3 memories. At follow-up, their age at the time of these memories…

  1. Follow-up of treated coeliac patients: Sugar absorption test and intestinal biopsies compared

    NARCIS (Netherlands)

    Uil, J. J.; van Elburg, R. M.; van Overbeek, F. M.; Meyer, J. W.; Mulder, C. J.; Heymans, H. S.

    1996-01-01

    Objective: To determine whether the sugar absorption test (SAT) during follow-up of patients with coeliac disease on a gluten-free diet (GFD) correlates with improvement of the villous architecture of the small intestine. Methods: The SAT was performed in coeliacs at diagnosis and during follow-up

  2. Nurse-Led Telephone Follow-up: Improving Options for Women With Endometrial Cancer

    NARCIS (Netherlands)

    Smits, A.; Lopes, A.; Das, N.; Bekkers, R.L.M.; Kent, E.; McCullough, Z.; Galaal, K.

    2015-01-01

    BACKGROUND: Nurse-led follow-up (NLFU) has been identified as a suitable means of follow-up care in cancer patients, and its acceptability has already been demonstrated in other areas of cancer care. OBJECTIVES: The objectives of this study were to evaluate the effect of NLFU on quality of life and

  3. Effective follow-up consultations : the importance of patient-centered communication and shared decision making

    NARCIS (Netherlands)

    Brand, Paul L. P.; Stiggelbout, Anne M.

    2013-01-01

    Paediatricians spend a considerable proportion of their time performing follow-up visits for children with chronic conditions, but they rarely receive specific training on how best to perform such consultations. The traditional method of running a follow-up consultation is based on the doctor's

  4. International clinical guideline for the management of classical galactosemia: diagnosis, treatment, and follow-up

    NARCIS (Netherlands)

    Welling, Lindsey; Bernstein, Laurie E.; Berry, Gerard T.; Burlina, Alberto B.; Eyskens, François; Gautschi, Matthias; Grünewald, Stephanie; Gubbels, Cynthia S.; Knerr, Ina; Labrune, Philippe; van der Lee, Johanna H.; MacDonald, Anita; Murphy, Elaine; Portnoi, Pat A.; Õunap, Katrin; Potter, Nancy L.; Rubio-Gozalbo, M. Estela; Spencer, Jessica B.; Timmers, Inge; Treacy, Eileen P.; van Calcar, Sandra C.; Waisbren, Susan E.; Bosch, Annet M.

    2017-01-01

    Classical galactosemia (CG) is an inborn error of galactose metabolism. Evidence-based guidelines for the treatment and follow-up of CG are currently lacking, and treatment and follow-up have been demonstrated to vary worldwide. To provide patients around the world the same state-of-the-art in care,

  5. Follow-up care for breast cancer survivors: improving patient outcomes

    Directory of Open Access Journals (Sweden)

    Chopra I

    2014-08-01

    Full Text Available Ishveen Chopra,1 Avijeet Chopra2 1Department of Pharmacy Administration, Duquesne University, Pittsburgh, PA, USA; 2Department of Molecular and Cell Biology, University of Connecticut, Storrs, CT, USA Background: Appropriate follow-up care is important for improving health outcomes in breast cancer survivors (BCSs and requires determination of the optimum intensity of clinical examination and surveillance, assessment of models of follow-up care such as primary care-based follow-up, an understanding of the goals of follow-up care, and unique psychosocial aspects of care for these patients. The objective of this systematic review was to identify studies focusing on follow-up care in BCSs from the patient's and physician's perspective or from patterns of care and to integrate primary empirical evidence on the different aspects of follow-up care from these studies. Methods: A comprehensive literature review and evaluation was conducted for all relevant publications in English from January 1, 1990 to December 31, 2013 using electronic databases. Studies were included in the final review if they focused on BCS’s preferences and perceptions, physician's perceptions, patterns of care, and effectiveness of follow-up care. Results: A total of 47 studies assessing the different aspects of follow-up care were included in the review, with a majority of studies (n=13 evaluating the pattern of follow-up care in BCSs, followed by studies focusing on BCS's perceptions (n=9 and preferences (n=9. Most of the studies reported variations in recommended frequency, duration, and intensity of follow-up care as well as frequency of mammogram screening. In addition, variations were noted in patient preferences for type of health care provider (specialist versus non-specialist. Further, BCSs perceived a lack of psychosocial support and information for management of side effects. Conclusion: The studies reviewed, conducted in a range of settings, reflect variations in

  6. Exploration of Postoperative Follow-up Strategies for Early Staged NSCLC Patients on the Basis of Follow-up Result of 416 Stage I NSCLC Patients after Lobectomy

    Directory of Open Access Journals (Sweden)

    Liang DAI

    2018-03-01

    Full Text Available Background and objective Currently, there is no consensus on the follow-up strategy (follow-up time interval and content of non-small cell lung cancer (NSCLC in the world, and the relevant clinical evidence is also very limited. In this study, we aimed to summarize the recurrence/metastasis sites and timings of stage I NSCLC patients based on their follow-up data, aiming to provide a basis of follow-up time interval and content for this group of patients. Methods We retrospectively analyzed the 416 stage I NSCLC patients that underwent continuous anatomic lobectomy between Jan. 2000 to Oct. 2013 in our prospective lung cancer database. According to the recurrence/metastasis sites and timings, the long term follow-up time interval and content were explored. Results The 5-yr disease free survival (DFS and overall survival (OS in the whole group were 82.4% and 85.4%, respectively. There were 76 cases (18.3% had recurrence/metastasis during follow-up, among which the most frequent site was pulmonary metastasis (21 cases, 5.0%, followed by brain metastasis (20 cases, 4.8%, bone metastasis (12 cases, 2.9%, and mediastinal lymph node metastasis (12 cases, 2.9%. Among the factors that could influence recurrence/metastasis, patients with pT2a suffered from a higher recurrence/metastasis rate compared to patients with pT1 (P=0.006, with 5-yr DFS being 73.8% and 87.3%, respectively (P=0.002, and the 5-yr OS being 77.7% and 90.3%, respectively (P=0.011. Conclusion The commonest recurrence/metastasis sites of stage I NSCLC after anatomic lobectomy are lung, brain and mediastinal lymph nodes, the risk of recurrence/metastasis within 2 years were equal to that between 3 years and 5 years. The follow-up frequencies and content within 2 years could be adjusted according to T stages.

  7. Detecting violations of temporal regularities in waking and sleeping two-month-old infants

    NARCIS (Netherlands)

    Otte, R.A.; Winkler, I.; Braeken, M.A.K.A.; Stekelenburg, J.J.; van der Stelt, O.; Van den Bergh, B.R.H.

    2013-01-01

    Correctly processing rapid sequences of sounds is essential for developmental milestones, such as language acquisition. We investigated the sensitivity of two-month-old infants to violations of a temporal regularity, by recording event-related brain potentials (ERPs) in an auditory oddball paradigm

  8. Pondering Motivational Ups and Downs throughout a Two-Month Period: A Complex Dynamic System Perspective

    Science.gov (United States)

    Lasagabaster, David

    2017-01-01

    This paper describes a two-month longitudinal study in which five secondary education students learning English as a foreign language at school will be interviewed in order to analyse how their motivation varies during this period and what variables affect their motivational changes. The emphasis will thus be on motivation's dynamicity and…

  9. Congenital cystic adenomatoid malformation: case presentation in a two months old infant

    International Nuclear Information System (INIS)

    Aqrabawi, H.E.; Shabatat, M.; Abbadi, B.M.

    2015-01-01

    Congenital cystic adenomatoid malformation (CCAM) is a rare abnormality of lung development; it is increasingly detected by the routine ultrasound scan during pregnancy. The severity of the abnormality is very variable. Herein, we present a case of congenital cystic adenomatoid malformation that presented in a two months old infant who had normal initial chest X rays. (author)

  10. Recurrence after surgery due to cervical cancer - An evaluation of the follow-up program

    DEFF Research Database (Denmark)

    Fuglsang, Katrine; Petersen, Lone Kjeld; Blaakær, Jan

    Objective During the last 20 years the follow-up program after surgical treatment for cervical cancer has remained unchanged. Surprisingly, little is communicated in relation to the follow-up program even though it has a huge impact on the life of the women and their relatives for five years....... The focus for this study is to evaluate the follow-up program in fulfilling the purpose for early diagnosis of recurrence while reminding and concerning women, who we consider healthy after surgery, 10 times during five years. Already politicians are focusing on the subject due to the socioeconomic...... consequences, but there is a need for a foundation prior to an adjustment of the follow-up program. Methods Design: retrospective study of a cohort of women attending follow-up program after surgery due to cervical cancer. Material: From the patient register at the Department of Gynaecology and Obstetrics...

  11. Increasing Follow-up Outcomes of At-Risk Alcohol Patients Using Motivational Interviewing.

    Science.gov (United States)

    Wagner, Andrew J; Garbers, Rachael; Lang, Ann; Borgert, Andrew J; Fisher, Mason

    2016-01-01

    Our trauma division implemented a screening, brief intervention, and referral to treatment (SBIRT) program in 2009 and has maintained more than 92% screening rate for all inpatient admissions since inception. Brief interventions are proven to be more likely to effect and reinforce change if a follow-up contact is made with patients. This led to discussion regarding whether identified patients were more likely to follow up with our SBIRT wellness specialist using motivational interviewing or with our partners, exercise physiology, who use traditional interviewing techniques. We retrospectively reviewed more than 3,000 inpatient admissions in which screening for at-risk alcohol use were positive. Fifty-one percent of identified patients were referred for wellness specialist consultation with a follow-up rate of 52% compared with a follow-up rate of only 21% in the exercise physiology group. Motivational interviewing is more effective in encouraging at-risk alcohol users to participate in follow-up care.

  12. EA follow-up in the Ghanaian mining sector: Challenges and opportunities

    International Nuclear Information System (INIS)

    Appiah-Opoku, Seth; Bryan, Hobson C.

    2013-01-01

    Environmental assessment (EA) follow-up provides a means for monitoring and evaluating the implementation of environmental impact studies. It is integral to the success or failure of a project or program. In spite of its importance, very little attention is given to the need for follow-up programs in most jurisdictions in Africa. Using a case study in the Ghanaian mining sector, this paper explores the challenges and opportunities within the country's EA process for an effective follow-up program. The paper is based on informal interviews, content analysis of relevant publications, official EA documents, and internet searches. The authors suggest a standard EA follow-up program to be formalized as an integral part of Ghana's environmental assessment policy. They also propose a follow-up process that harnesses existing opportunities within the country's EA system. This approach can be replicated in other African countries

  13. [Health management system in outpatient follow-up of kidney transplantation patients].

    Science.gov (United States)

    Zhang, Hong; Xie, Jinliang; Yao, Hui; Liu, Ling; Tan, Jianwen; Geng, Chunmi

    2014-07-01

    To develop a health management system for outpatient follow-up of kidney transplant patients. Access 2010 database software was used to establish the health management system for kidney transplantation patients in Windows XP operating system. Database management and post-operation follow-up of the kidney transplantation patients were realized through 6 function modules including data input, data query, data printing, questionnaire survey, data export, and follow-up management. The system worked stably and reliably, and the data input was easy and fast. The query, the counting and printing were convenient. Health management system for patients after kidney transplantation not only reduces the work pressure of the follow-up staff, but also improves the efficiency of outpatient follow-up.

  14. Nut consumption and incidence of metabolic syndrome after 6-year follow-up: the SUN (Seguimiento Universidad de Navarra, University of Navarra Follow-up) cohort.

    Science.gov (United States)

    Fernández-Montero, Alejandro; Bes-Rastrollo, Maira; Beunza, Juan J; Barrio-Lopez, Maria Teresa; de la Fuente-Arrillaga, Carmen; Moreno-Galarraga, Laura; Martínez-González, Miguel Angel

    2013-11-01

    To assess the long-term relationship between tree nut consumption and the risk of developing metabolic syndrome (MetS). Nut consumption was collected using a validated 136-item FFQ. The MetS was defined according to the International Diabetes Federation and American Heart Association/National Heart, Lung, and Blood Institute harmonizing definition. The association between nut consumption and MetS was assessed with logistic regression models adjusting for potential confounders. We compared the incidence of MetS between extreme categories of nut intake (> or = 2 servings/week v. never/almost never) after 6 years of follow-up. The SUN Project (Seguimiento Universidad de Navarra, University of Navarra Follow-up) is a prospective cohort study, formed of Spanish university graduates. Information is gathered by mailed questionnaires collected biennially. Nut consumption and MetS information was collected by self-reported data. Participants (n 9887) initially free of MetS or diabetes and followed up for a minimum of 6 years were included. We observed 567 new cases of MetS during follow-up. Participants who consumed nuts > or = 2 servings/week presented a 32% lower risk of developing MetS than those who never/almost never consumed (adjusted OR = 0.68, 95% CI 0.50, 0.92). The inverse association was stronger among participants who were health professionals. Nut consumption was significantly associated with lower risk of developing MetS after a 6-year follow-up period in a cohort of Spanish graduates.

  15. Oral administration of a curcumin-phospholipid delivery system for the treatment of central serous chorioretinopathy: a 12-month follow-up study

    Directory of Open Access Journals (Sweden)

    Mazzolani F

    2013-05-01

    Full Text Available Fabio Mazzolani,1 Stefano Togni21Private Ophthalmology Practice, 2Indena SpA, Milan, ItalyBackground: The therapeutic effects of Meriva®, a curcumin-phospholipid (lecithin delivery system (formulated as Norflo® tablets, on visual acuity and retinal thickness in patients with acute and chronic central serous chorioretinopathy was previously investigated in a six-month open-label study.Methods: In this follow-up study, visual acuity was again assessed by ophthalmologic evaluation and retinal thickness by optical coherence tomography (OCT. Norflo tablets were administered twice daily to patients with central serous chorioretinopathy. The study group consisted of 12 patients (total 18 eyes who completed 12 months of follow-up. The primary endpoint was change in visual acuity before and after treatment with Norflo, and change in neuroretinal or retinal pigment epithelium detachment on OCT was the secondary endpoint.Results: After 12 months of therapy, no eyes showed further reduction in visual acuity, 39% showed stabilization, and 61% showed statistically significant improvement (P = 0.0001 by Student’s t-test and P = 0.0005 by Wilcoxon signed rank test. Ninety-five percent of eyes showed a reduction in neuroretinal or retinal pigment epithelium detachment and 5% showed stabilization. The difference in retinal thickness after 12 months was statistically significant (P = 0.0001 by Student’s t-test and P = 0.0004 by Wilcoxon signed rank test.Conclusion: These results, albeit preliminary, confirm our previous finding that this curcumin delivery system is effective in the management of central serous chorioretinopathy. When administered in a bioavailable formulation, curcumin is worth considering as a therapeutic agent for the management of inflammatory and degenerative eye conditions involving activation of retinal microglial cells.Keywords: curcumin, central serous chorioretinopathy, retinal pigment epithelium detachment, Norflo®, Meriva®

  16. Factors associated with intentions to adhere to colorectal cancer screening follow-up exams

    Directory of Open Access Journals (Sweden)

    Ishibashi Teruo

    2006-11-01

    Full Text Available Abstract Background To increase adherence rate to recommendations for follow-up after abnormal colorectal cancer (CRC screening results, factors that inhibit and facilitate follow-up must be identified. The purpose of this study was to identify the factors associated with intention to adhere to CRC screening follow-up exams. Methods During a 4-week period in October 2003, this survey was conducted with 426 subjects participating in a community-based CRC screening program in Nagano, Japan. Study measures included intention to adhere to recommendation for clinical follow-up in the event of an abnormal fecal occult blood test (FOBT result, perceived susceptibility and severity of CRC, perceived benefits and barriers related to undergoing follow-up examination, social support, knowledge of CRC risk factors, health status, previous CRC screening, personality and social demographic characteristics. Univariate and multivariate logistic regression analyses on intention to adhere to recommendations for follow-up were performed. Results Among the 288 individuals analyzed, approximately 74.7% indicated that they would definitely adhere to recommendations for follow-up. After controlling for age, gender, marital status, education, economic status, trait anxiety, bowel symptoms, family history of CRC, and previous screening FOBT, analyses revealed that lower levels of perceived barriers, higher levers of perceived benefits and knowledge of CRC risk factors were significantly associated with high intention respectively. Conclusion The results of this study suggest that future interventions should focus on reducing modifiable barriers by clarifying misperceptions about follow-up, promoting the acceptance of complete diagnostic evaluations, addressing psychological distress, and making follow-up testing more convenient and accessible. Moreover, educating the public regarding the risk factors of CRC and increasing understanding of the benefits of follow-up is

  17. Utility of MRI in the follow-up of pyogenic spinal infection in children

    International Nuclear Information System (INIS)

    Wang, Qiuyan; Babyn, Paul; Branson, Helen; Davila, Jorge; Mueller, Edrise L.; Tran, Dat

    2010-01-01

    MRI is used at an increasing rate in evaluation of pediatric spinal infections both at the time of diagnosis and in follow-up. However, the impact of MRI in follow-up has been rarely evaluated to date. To evaluate serial follow-up spinal MRI changes compared to clinical outcome and assess their impact on clinical management. All pediatric (<18 years) patients with pyogenic spinal infection over a 9-year period with at least one follow-up after treatment were included. Atypical infections were excluded. We examined 35 whole-spine and 16 localized spinal scans from 17 patients (2 months to 16 years, 9F:8 M) who had 51 follow-ups done 2 weeks to 4.75 years after baseline. Seven children (41%) younger than 3 years underwent 33 follow-ups (65%); most required GA or sedation. Short-term follow-up scans demonstrated epidural and/or paraspinal soft-tissue changes correlating with clinical status and laboratory findings in all cases. However, MRI showed that bone and/or disc abnormalities continued and progressed in some cases despite clinical improvement. Long-term follow-up scans showed bone, disc and soft-tissue changes 1-3 years after baseline, despite children being symptom free. Extension of antibiotics occurred in 47% of children partly based on follow-up MRI. Epidural and paraspinal soft-tissue changes correlated with children's clinical symptoms. Progression of bone and disc changes can manifest despite adequate clinical response. Long-term or serial routine follow-ups were not necessary. Management should be made based on clinical response. (orig.)

  18. New methods for estimating follow-up rates in cohort studies

    Directory of Open Access Journals (Sweden)

    Xiaonan Xue

    2017-12-01

    Full Text Available Abstract Background The follow-up rate, a standard index of the completeness of follow-up, is important for assessing the validity of a cohort study. A common method for estimating the follow-up rate, the “Percentage Method”, defined as the fraction of all enrollees who developed the event of interest or had complete follow-up, can severely underestimate the degree of follow-up. Alternatively, the median follow-up time does not indicate the completeness of follow-up, and the reverse Kaplan-Meier based method and Clark’s Completeness Index (CCI also have limitations. Methods We propose a new definition for the follow-up rate, the Person-Time Follow-up Rate (PTFR, which is the observed person-time divided by total person-time assuming no dropouts. The PTFR cannot be calculated directly since the event times for dropouts are not observed. Therefore, two estimation methods are proposed: a formal person-time method (FPT in which the expected total follow-up time is calculated using the event rate estimated from the observed data, and a simplified person-time method (SPT that avoids estimation of the event rate by assigning full follow-up time to all events. Simulations were conducted to measure the accuracy of each method, and each method was applied to a prostate cancer recurrence study dataset. Results Simulation results showed that the FPT has the highest accuracy overall. In most situations, the computationally simpler SPT and CCI methods are only slightly biased. When applied to a retrospective cohort study of cancer recurrence, the FPT, CCI and SPT showed substantially greater 5-year follow-up than the Percentage Method (92%, 92% and 93% vs 68%. Conclusions The Person-time methods correct a systematic error in the standard Percentage Method for calculating follow-up rates. The easy to use SPT and CCI methods can be used in tandem to obtain an accurate and tight interval for PTFR. However, the FPT is recommended when event rates and

  19. Ibrutinib for patients with rituximab-refractory Waldenström's macroglobulinaemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial.

    Science.gov (United States)

    Dimopoulos, Meletios A; Trotman, Judith; Tedeschi, Alessandra; Matous, Jeffrey V; Macdonald, David; Tam, Constantine; Tournilhac, Olivier; Ma, Shuo; Oriol, Albert; Heffner, Leonard T; Shustik, Chaim; García-Sanz, Ramón; Cornell, Robert F; de Larrea, Carlos Fernández; Castillo, Jorge J; Granell, Miquel; Kyrtsonis, Marie-Christine; Leblond, Veronique; Symeonidis, Argiris; Kastritis, Efstathios; Singh, Priyanka; Li, Jianling; Graef, Thorsten; Bilotti, Elizabeth; Treon, Steven; Buske, Christian

    2017-02-01

    In the era of widespread rituximab use for Waldenström's macroglobulinaemia, new treatment options for patients with rituximab-refractory disease are an important clinical need. Ibrutinib has induced durable responses in previously treated patients with Waldenström's macroglobulinaemia. We assessed the efficacy and safety of ibrutinib in a population with rituximab-refractory disease. This multicentre, open-label substudy was done at 19 sites in seven countries in adults aged 18 years and older with confirmed Waldenström's macroglobulinaemia, refractory to rituximab and requiring treatment. Disease refractory to the last rituximab-containing therapy was defined as either relapse less than 12 months since last dose of rituximab or failure to achieve at least a minor response. Key exclusion criteria included: CNS involvement, a stroke or intracranial haemorrhage less than 12 months before enrolment, clinically significant cardiovascular disease, hepatitis B or hepatitis C viral infection, and a known bleeding disorder. Patients received oral ibrutinib 420 mg once daily until progression or unacceptable toxicity. The substudy was not prospectively powered for statistical comparisons, and as such, all the analyses are descriptive in nature. This study objectives were the proportion of patients with an overall response, progression-free survival, overall survival, haematological improvement measured by haemoglobin, time to next treatment, and patient-reported outcomes according to the Functional Assessment of Cancer Therapy-Anemia (FACT-An) and the Euro Qol 5 Dimension Questionnaire (EQ-5D-5L). All analyses were per protocol. The study is registered at ClinicalTrials.gov, number NCT02165397, and follow-up is ongoing but enrolment is complete. Between Aug 18, 2014, and Feb 18, 2015, 31 patients were enrolled. Median age was 67 years (IQR 58-74); 13 (42%) of 31 patients had high-risk disease per the International Prognostic Scoring System Waldenstr

  20. Complementary feeding at 4 versus 6 months of age for preterm infants born at less than 34 weeks of gestation: a randomised, open-label, multicentre trial

    Directory of Open Access Journals (Sweden)

    Shuchita Gupta, MD

    2017-05-01

    Full Text Available Summary: Background: Evidence on the optimal time to initiation of complementary feeding in preterm infants is scarce. We examined the effect of initiation of complementary feeding at 4 months versus 6 months of corrected age on weight for age at 12 months corrected age in preterm infants less than 34 weeks of gestation. Methods: In this open-label, randomised trial, we enrolled infants born at less than 34 weeks of gestation with no major malformation from three public health facilities in India. Eligible infants were tracked from birth and randomly assigned (1:1 at 4 months corrected age to receive complementary feeding at 4 months corrected age (4 month group, or continuation of milk feeding and initiation of complementary feeding at 6 months corrected age (6 month group, using computer generated randomisation schedule of variable block size, stratified by gestation (30 weeks or less, and 31–33 weeks. Iron supplementation was provided as standard. Participants and the implementation team could not be masked to group assignment, but outcome assessors were masked. Primary outcome was weight for age Z-score at 12 months corrected age (WAZ12 based on WHO Multicentre Growth Reference Study growth standards. Analyses were by intention to treat. The trial is registered with Clinical Trials Registry of India, number CTRI/2012/11/003149. Findings: Between March 20, 2013, and April 24, 2015, 403 infants were randomly assigned: 206 to receive complementary feeding from 4 months and 197 to receive complementary feeding from 6 months. 22 infants in the 4 month group (four deaths, two withdrawals, 16 lost to follow-up and eight infants in the 6 month group (two deaths, six lost to follow-up were excluded from analysis of primary outcome. There was no difference in WAZ12 between two groups: −1·6 (SD 1·2 in the 4 month group versus −1·6 (SD 1·3 in the 6 month group (mean difference 0·005, 95% CI −0·24 to 0·25; p=0·965. There were more

  1. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

    Science.gov (United States)

    McCormack, Sheena; Dunn, David T; Desai, Monica; Dolling, David I; Gafos, Mitzy; Gilson, Richard; Sullivan, Ann K; Clarke, Amanda; Reeves, Iain; Schembri, Gabriel; Mackie, Nicola; Bowman, Christine; Lacey, Charles J; Apea, Vanessa; Brady, Michael; Fox, Julie; Taylor, Stephen; Antonucci, Simone; Khoo, Saye H; Rooney, James; Nardone, Anthony; Fisher, Martin; McOwan, Alan; Phillips, Andrew N; Johnson, Anne M; Gazzard, Brian; Gill, Owen N

    2016-01-01

    Summary Background Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir–emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect. Methods PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986). Findings We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1·2/100 person-years) versus 20 in the deferred group (9·0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64–96, p=0·0001; absolute difference 7·8/100 person-years, 90% CI 4·3–11·3). 13 men (90% CI 9–23

  2. The role of the follow-up chest radiograph in suspected non-accidental injury

    Energy Technology Data Exchange (ETDEWEB)

    Anilkumar, Adikesavalu; Fender, Laura J; Broderick, Nigel J; Somers, John M; Halliday, Katharine E [Nottingham University Hospital NHS Trust, Department of Radiology, Queen' s Medical Centre, Nottingham (United Kingdom)

    2006-03-15

    Rib fractures in children under the age of 2 years have a strong correlation with non-accidental injury (NAI). Follow-up radiographs can improve detection. To evaluate the value of the follow-up chest radiograph in suspected non-accidental injury. The study included all children less than 2 years of age who were investigated for suspected NAI in our institution between January 1998 and October 2003. Prior to January 2000, only selected patients were asked to attend for a follow-up chest radiograph. From January 2000 onwards all children were asked to reattend. Of 200 children included in the study, 59 (29.5%) reattended for a follow-up chest radiograph. The follow-up film provided useful additional information in 7 (12%) of the 59 children. In two children rib fractures were noted only on the follow-up chest radiograph. In a further two patients additional rib fractures were noted. Additional dating information was obtained for two patients. For one child both additional fractures and dating information were noted. The follow-up chest radiograph provides useful information in children with suspected NAI and it is recommended that it should be included routinely in the imaging investigations of these children. (orig.)

  3. The role of the follow-up chest radiograph in suspected non-accidental injury

    International Nuclear Information System (INIS)

    Anilkumar, Adikesavalu; Fender, Laura J.; Broderick, Nigel J.; Somers, John M.; Halliday, Katharine E.

    2006-01-01

    Rib fractures in children under the age of 2 years have a strong correlation with non-accidental injury (NAI). Follow-up radiographs can improve detection. To evaluate the value of the follow-up chest radiograph in suspected non-accidental injury. The study included all children less than 2 years of age who were investigated for suspected NAI in our institution between January 1998 and October 2003. Prior to January 2000, only selected patients were asked to attend for a follow-up chest radiograph. From January 2000 onwards all children were asked to reattend. Of 200 children included in the study, 59 (29.5%) reattended for a follow-up chest radiograph. The follow-up film provided useful additional information in 7 (12%) of the 59 children. In two children rib fractures were noted only on the follow-up chest radiograph. In a further two patients additional rib fractures were noted. Additional dating information was obtained for two patients. For one child both additional fractures and dating information were noted. The follow-up chest radiograph provides useful information in children with suspected NAI and it is recommended that it should be included routinely in the imaging investigations of these children. (orig.)

  4. Passive versus active follow-up to investigate the efficacy of primary prevention programs

    Directory of Open Access Journals (Sweden)

    Högel, Josef

    2005-04-01

    Full Text Available Before general application of a primary prevention program its efficacy has to be demonstrated. For this purpose a randomized controlled trial with active or passive follow-up may be conducted. In the last 5 years, the ratio of controlled trials with passive versus those with active follow-up was 1:13. However, under certain circumstances a passive follow-up may be more appropriate and useful to overcome the drawbacks of an active follow-up, as e.g. high costs and many drop-outs. In a randomized controlled trial, a passive follow-up is based on the reporting of cases by physicians or hospitals instead of actively following up all study participants individually. The statistical evaluation can be carried out using a one-sample chi2-test. Advantages and limitations are discussed. A passive follow-up may be advantageous in situations with low incidence, large number of participants, complete ascertainment of conditions with obligatory notification or effective disease registries and should be preferred in such a context.

  5. Can follow-up examination of tuberculosis patients be simplified? A study in Chhattisgarh, India.

    Directory of Open Access Journals (Sweden)

    Debashish Kundu

    Full Text Available BACKGROUND: Each follow-up during the course of tuberculosis treatment currently requires two sputum examinations. However, the incremental yield of the second sputum sample during follow-up of different types of tuberculosis patients has never been determined precisely. OBJECTIVES: To assess the incremental yield of the second sputum sample in the follow-up of tuberculosis patients under the Revised National Tuberculosis Control Programme (RNTCP in Chhattisgarh, India. METHODOLOGY: A record review of tuberculosis (TB patients registered in 2009 using a structured proforma from two sources, Tuberculosis and Laboratory Register, was undertaken in the six districts of Chhattisgarh, India. RESULTS: In smear positive cases, of 10,048 follow-up examinations, 45 (0.5% were found to be smear positive only on the second sputum when the result of the first sample was negative. In smear negative pulmonary and extra pulmonary TB patients, of 6,206 follow-up smear examinations, 11(0.2% were found to be smear positive. CONCLUSIONS: The incremental yield of a second smear examination was very low, indicating that examination of one sputum sample is enough during follow-up among TB patients. There is insufficient yield to support sputum smear microscopy for monitoring smear negative pulmonary TB and extra pulmonary TB patients. These results indicate that the follow-up smear microscopy can be substantially simplified with favourable resource implications.

  6. Adherence to Follow-Up Recommendations by Triathlon Competitors Receiving Event Medical Care.

    Science.gov (United States)

    Joslin, Jeremy D; Lloyd, Jarem B; Copeli, Nikoli; Cooney, Derek R

    2017-01-01

    Introduction . We sought to investigate triathlete adherence to recommendations for follow-up for participants who received event medical care. Methods . Participants of the 2011 Ironman Syracuse 70.3 (Syracuse, NY) who sought evaluation and care at the designated finish line medical tent were contacted by telephone approximately 3 months after the initial encounter to measure adherence with the recommendation to seek follow-up care after event. Results . Out of 750 race participants, 35 (4.6%) athletes received event medical care. Of these 35, twenty-eight (28/35; 80%) consented to participate in the study and 17 (61%) were available on telephone follow-up. Of these 17 athletes, 11 (11/17; 65%) of participants reported that they had not followed up with a medical professional since the race. Only 5 (5/17; 29%) confirmed that they had seen a medical provider in some fashion since the race; of these, only 2 (2/17; 12%) sought formal medical follow-up resulting from the recommendation whereas the remaining athletes merely saw their medical providers coincidentally or as part of routine care. Conclusion . Only 2 (2/17; 12%) of athletes who received event medical care obtained postrace follow-up within a one-month time period following the race. Event medical care providers must be aware of potential nonadherence to follow-up recommendations.

  7. Adherence to Follow-Up Recommendations by Triathlon Competitors Receiving Event Medical Care

    Directory of Open Access Journals (Sweden)

    Jeremy D. Joslin

    2017-01-01

    Full Text Available Introduction. We sought to investigate triathlete adherence to recommendations for follow-up for participants who received event medical care. Methods. Participants of the 2011 Ironman Syracuse 70.3 (Syracuse, NY who sought evaluation and care at the designated finish line medical tent were contacted by telephone approximately 3 months after the initial encounter to measure adherence with the recommendation to seek follow-up care after event. Results. Out of 750 race participants, 35 (4.6% athletes received event medical care. Of these 35, twenty-eight (28/35; 80% consented to participate in the study and 17 (61% were available on telephone follow-up. Of these 17 athletes, 11 (11/17; 65% of participants reported that they had not followed up with a medical professional since the race. Only 5 (5/17; 29% confirmed that they had seen a medical provider in some fashion since the race; of these, only 2 (2/17; 12% sought formal medical follow-up resulting from the recommendation whereas the remaining athletes merely saw their medical providers coincidentally or as part of routine care. Conclusion. Only 2 (2/17; 12% of athletes who received event medical care obtained postrace follow-up within a one-month time period following the race. Event medical care providers must be aware of potential nonadherence to follow-up recommendations.

  8. Compliance with follow-up after cataract surgery in rural China.

    Science.gov (United States)

    Huang, Guofu; Crooms, Rita; Chen, Qianyun; Congdon, Nathan; He, Mingguang

    2012-04-01

    To evaluate reasons for non-compliance with post-cataract surgical follow-up in rural China, and assess the impact of incentives on improving compliance. Patients having undergone cataract surgery more than 3 months previously at cataract surgery training hospitals in Guangdong were invited by telephone and advertisements to a hospital-based study examination, with compensation for travel costs (US$7). Information on prior post-surgical follow up was collected by questionnaire at the hospital or by telephone. Logistic regression was used to assess predictors of post-operative attendance with or without compensation. Among 518 eligible patients, 426 (82.2%) underwent interviews and 342 (66.0%) attended the compensated study examination. Ninety nine participants (23.2%) reported previously returning for uncompensated follow-up ≥ 3 months post-operatively, and 225 (52.8%) had returned for any prior post-operative examination. Uncompensated follow-up at ≥ 3 months was associated with higher income (P = 0.037), and recalling instruction by a doctor to follow-up (P = 0.001), while age, gender, travel cost, and post-operative satisfaction and vision were not associated. Younger (P = 0.002) patients and those reporting being instructed to follow up (P = 0.008) were more likely to return for the compensated research examination. Among all interviewed subjects, only 170 (39.9%) reported knowing they were to return to hospital. Modest compensation, advertisements and telephone contact can increase medium-term follow-up rates after cataract surgery by three-fold. Better communication of specific targets for follow-up may improve follow-up compliance.

  9. A Facebook Follow-Up Strategy for Rural Drug-Using Women.

    Science.gov (United States)

    Dickson, Megan F; Staton-Tindall, Michele; Smith, Kirsten E; Leukefeld, Carl; Webster, J Matthew; Oser, Carrie B

    2017-06-01

    Facebook (FB) use has grown exponentially over the past decade, including in rural areas. Despite its popularity, FB has been underutilized as a research follow-up approach to maintain contact with research participants and may have advantages in less densely populated areas and among more hard-to-reach, at-risk groups. The overall goal of this study was to examine FB as a supplemental follow-up approach to other follow-up strategies with rural drug-using women. Face-to-face interviews were conducted with randomly selected women who completed baseline interviews in 3 rural jails in 1 state. Analyses focus on participants who were released from jail and were eligible for 3-month follow-up (n = 284). Bivariate analyses were used to examine differences between FB users and nonusers, and multivariate logistic regression models examined predictors of 3-month follow-up participation and being located for follow-up using FB. About two-thirds (64.4%) of participants were regular FB users. Bivariate analyses indicated that FB users were younger, more educated, and more likely to have used alcohol in the 30 days before incarceration but less likely to have a chronic health problem. Regression analyses indicated that rural FB users had more than 5 times the odds of being located for the 3-month follow-up interview, even after controlling for other variables. There were no significant predictors of being followed up using FB. Findings suggest that FB is widely used and well accepted among rural drug-using women. Among hard-to-reach populations, including those in rural, geographically isolated regions, FB serves as a method to improve participant follow-up. © 2016 National Rural Health Association.

  10. Occupational disease disclosed by preventive follow-up of former uranium ore miners

    International Nuclear Information System (INIS)

    Pacina, V.; Vich, Z.; Elterlein, E.

    1982-01-01

    The aim of preventive follow-up examinations of former employees of the concern Czechoslovak Uranium Mines is to determine possible health damage of chronically exposed workers in an area that can become manifest even following a long time after leaving the high-risk working environment. In a group of 1,139 persons that had undergone preventive follow-up examinations in the years 1977 to 1980 there were 63 cases of newly detected affections that were reported as occupational diseases, and other serious affections. The system of preventive follow-up examinations represents a significant contribution to the improvement of health care of the workers. (author)

  11. A four-year follow-up study in fibromyalgia. Relationship to chronic fatigue syndrome

    DEFF Research Database (Denmark)

    Nørregaard, J; Bülow, P M; Prescott, E

    1993-01-01

    the overlap between fibromyalgia and chronic fatigue syndrome. Only in two of 91 the muscle pain was found to be caused by another somatic disease during the median 4 year follow-up period. In one of the 83 attending subjects a somatic disease associated with muscle symptoms was established at the follow......-up visit. 60 out of 83 reported increased pain, 8 reported improvement of pain. The 83 subjects showed no significant fall in muscle strength during the follow-up period. The majority reported severe fatigue but only one fifth fulfilled the proposed chronic fatigue syndrome criteria....

  12. Long-term follow-up of echolalia and question answering.

    OpenAIRE

    Foxx, R M; Faw, G D

    1990-01-01

    A long-term follow-up of echolalia and correct question answering was conducted for 6 subjects from three previously published studies. The follow-up periods ranged from 26 to 57 months. In a training site follow-up, subjects were exposed to baseline/posttraining conditions in which the original trainer and/or a novel person(s) presented trained and untrained questions. Four subjects displayed echolalia below baseline levels, and another did so in some assessments. Overall, echolalia was lowe...

  13. Long-term adherence to follow-up after treatment of cervical intraepithelial neoplasia

    DEFF Research Database (Denmark)

    Barken, Sidsel S; Lynge, Elsebeth; Andersen, Erik S.

    2013-01-01

    OBJECTIVE: To measure adherence to annual follow-up among women treated for cervical intraepithelial neoplasia. DESIGN: Prospective, population-based, register study. SETTING: Denmark, 1996-2007. POPULATION: All women treated for cervical intraepithelial neoplasia with conization. METHODS: Treated...... was poor in Denmark. Our findings suggest that because of this poor adherence, recommendations for long-term annual follow-up after treatment of cervical intraepithelial neoplasia may not be highly effective. Shorter follow-up schedules using highly sensitive tests appear attractive....

  14. What Happens Next? Follow-Up From the Children's Toddler School Program

    OpenAIRE

    Akshoomoff, Natacha; Stahmer, Aubyn C.; Corsello, Christina; Mahrer, Nicole E.

    2010-01-01

    This study was a follow-up of a group of 29 children diagnosed with autism spectrum disorders at age 2 who attended an inclusive toddler program until age 3. Children ranged in age from 4 to 12 years at the time of the parent survey and follow-up testing. The majority of children were placed in a special education (noninclusive) preschool class, but among the children who were in elementary school at the time of follow-up, 63% were in general education classroom placement. Diagnoses of autism...

  15. Extended heart failure clinic follow-up in low-risk patients

    DEFF Research Database (Denmark)

    Schou, Morten; Gustafsson, Finn; Videbaek, Lars

    2013-01-01

    BackgroundOutpatient follow-up in specialized heart failure clinics (HFCs) is recommended by current guidelines and implemented in most European countries, but the optimal duration of HFC programmes has not been established. Nor is it known whether all or only high-risk patients, e.g. identified...... by NT-proBNP, might benefit from an extended HFC follow-up.Methods and resultsIn a multi-centre setting, we randomly assigned 921 clinically stable systolic heart failure (HF) outpatients on optimal medical therapy to undergo either an extended follow-up in the HFC (n = 461) or referral back...

  16. IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS OF A TWO-YEAR FOLLOW-UP STUDY

    Directory of Open Access Journals (Sweden)

    M. S. Naumtseva

    2016-01-01

    Full Text Available Objective: to investigate the immunogenicity, safety, and clinical efficacy of 23-valent polysaccharide pneumococcal vaccine in patients with rheumatoid arthritis (RA during a two-year follow-up study.Subjects and methods. The prospective open-label comparative study enrolled 110 people, of them there were 81 (73.6% women and 29 (26.4% men at the age of 23 to 76 years, including 79 patients with RA, as well as 31 subjects without systemic inflammatory rheumatic diseases (RD (a control group. The group of RA patients exhibited a predominance of middle-aged women who had > 3 years’ disease duration and a moderate inflammatory activity (the mean value of DAS28, 4.32. 52 patients received methotrexate (MTX, 14 had Leflunomide (LEF, and 13 were treated with tumor necrosis factor-α (TNF-α inhibitors + MTX.The 23-valent polysaccharide pneumococcal vaccine Pneumo-23 (Sanofi Pasteur, France was administered in a single dose of 0.5 ml subcutaneously during continuous MTX or LEF therapy for the underlying disease or 3–4 weeks before the use of TNF-α inhibitors. Clinical examinations of the patient and conventional clinical and laboratory studies were performed during control visits (1, 3, 12, and 24 months after vaccination. Clinical effectiveness and safety were evaluated in all the patients included in the study. The serum levels of anti-pneumococcal capsular polysaccharide antibodies (Ab were measured in 72 patients with RA and in 30 individuals in the control group during a 12-month follow-up study, including in 25 patients with RA for a 24-month follow-up study by enzyme immunoassay using commercial VaccZymeTM Anti-PCP IgG Enzyme Immunoassay kits (The Binding Site Group Ltd, Birmingham, United Kingdom. Along with this, the post-immunization response coefficient was calculated for each patient as the ratio of postvaccination Ab levels during Visits 2, 3, 4, and 5 to the baseline Ab level. Results and discussion. No clinical and

  17. Effectiveness of one-year pharmacological treatment of adult attention-deficit/hyperactivity disorder (ADHD): an open-label prospective study of time in treatment, dose, side-effects and comorbidity.

    Science.gov (United States)

    Fredriksen, Mats; Dahl, Alv A; Martinsen, Egil W; Klungsøyr, Ole; Haavik, Jan; Peleikis, Dawn E

    2014-12-01

    How to generalize from randomized placebo controlled trials of ADHD drug treatment in adults to 'real-world' clinical practice is intriguing. This open-labeled prospective observational study examined the effectiveness of long-term stimulant and non-stimulant medication in adult ADHD including dose, side-effects and comorbidity in a clinical setting. A specialized ADHD outpatient clinic gave previously non-medicated adults (n=250) with ADHD methylphenidate as first-line drug according to current guidelines. Patients who were non-tolerant or experiencing low efficacy were switched to amphetamine or atomoxetine. Primary outcomes were changes of ADHD-symptoms evaluated with the Adult ADHD Self-Report Scale (ASRS) and overall severity by the Global Assessment of Functioning (GAF). Secondary outcomes were measures of mental distress, and response on the Clinical-Global-Impressions-Improvement Scale. Data at baseline and follow-ups were compared in longitudinal mixed model analyses for time on-medication, dosage, comorbidity, and side-effects. As results, 232 patients (93%) completed examination at the 12 month endpoint, and 163 (70%) remained on medication. Compared with the patients who discontinued medication, those still on medication had greater percentage reduction in ASRS-scores (median 39%, versus 13%, Ptreatment with stimulants or atomoxetine was associated with a clinically significant reduction in ADHD symptoms and mental distress, and improvement of measured function. No serious adverse events were observed. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

  18. An Analysis of Patient Adherence to Treatment during a 1-Year, Open-Label Study of OROS[R] Methylphenidate in Children with ADHD

    Science.gov (United States)

    Faraone, Stephen V.; Biederman, Joseph; Zimmerman, Brenda

    2007-01-01

    Objective: Treatment adherence is an important aspect of ADHD symptom management, but there are many factors that may influence adherence. Method: This analysis assessed adherence to OROS methylphenidate during a 1-year, open-label study in children. Adherence was defined as the number of days medication was taken divided by the number of days in…

  19. Effect of Micronutrients on Behavior and Mood in Adults with ADHD: Evidence from an 8-Week Open Label Trial with Natural Extension

    Science.gov (United States)

    Rucklidge, Julia; Taylor, Mairin; Whitehead, Kathryn

    2011-01-01

    Objective: To investigate the effect of a 36-ingredient micronutrient formula consisting mainly of minerals and vitamins in the treatment of adults with both ADHD and severe mood dysregulation (SMD). Method: 14 medication-free adults (9 men, 5 women; 18-55 years) with ADHD and SMD completed an 8-week open-label trial. Results: A minority reported…

  20. Efficacy of Atomoxetine for the Treatment of ADHD Symptoms in Patients with Pervasive Developmental Disorders: A Prospective, Open-Label Study

    Science.gov (United States)

    Fernandez-Jaen, Alberto; Fernandez-Mayoralas, Daniel Martin; Calleja-Perez, Beatriz; Munoz-Jareno, Nuria; Campos Diaz, Maria del Rosario; Lopez-Arribas, Sonia

    2013-01-01

    Objective: Atomoxetine's tolerance and efficacy were studied in 24 patients with pervasive developmental disorder and symptoms of ADHD. Method: Prospective, open-label, 16-week study was performed, using the variables of the Clinical Global Impression Scale and the Conners' Scale, among others. Results: A significant difference was found between…

  1. Safety of Repeated Open-Label Treatment Courses of Intravenous Ofatumumab, a Human Anti-CD20 Monoclonal Antibody, in Rheumatoid Arthritis

    DEFF Research Database (Denmark)

    Quattrocchi, Emilia; Ostergaard, Mikkel; Taylor, Peter C.

    2016-01-01

    Objectives To investigate the safety of ofatumumab retreatment in rheumatoid arthritis. Methods Patients with active rheumatoid arthritis participating in two phase III trials (OFA110635 and OFA110634) and a phase II extension trial (OFA111752) received individualised open-label ofatumumab retrea...

  2. No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a Phase I Open Label Study to assess safety, tolerability and cytokine responses

    Science.gov (United States)

    Although Lactobacillus rhamnosus GG ATCC 53103 (LGG) has been consumed since the mid 1990s by between 2 and 5 million people daily, the scientific literature lacks rigorous clinical trials that describe the potential harms of LGG, particularly in the elderly. The primary objective of this open label...

  3. Effects of switching from olanzapine to aripiprazole on the metabolic profiles of patients with schizophrenia and metabolic syndrome: a double-blind, randomized, open-label study [Corrigendum

    Directory of Open Access Journals (Sweden)

    Wani RA

    2015-03-01

    Full Text Available Wani RA, Dar MA, Chandel RK, et al Title of paper should have been “Effects of switching from olanzapine to aripiprazole on the metabolic profiles of patients with schizophrenia and metabolic syndrome: a randomized, open-label study”.  Read the original paper 

  4. Dormaier and Chester Butte 2007 Follow-up Habitat Evaluation Procedures Report.

    Energy Technology Data Exchange (ETDEWEB)

    Ashley, Paul R.

    2008-01-01

    Follow-up habitat evaluation procedures (HEP) analyses were conducted on the Dormaier and Chester Butte wildlife mitigation sites in April 2007 to determine the number of additional habitat units to credit Bonneville Power Administration (BPA) for providing funds to enhance, and maintain the project sites as partial mitigation for habitat losses associated with construction of Grand Coulee Dam. The Dormaier follow-up HEP survey generated 482.92 habitat units (HU) or 1.51 HUs per acre for an increase of 34.92 HUs over baseline credits. Likewise, 2,949.06 HUs (1.45 HUs/acre) were generated from the Chester Butte follow-up HEP analysis for an increase of 1,511.29 habitat units above baseline survey results. Combined, BPA will be credited with an additional 1,546.21 follow-up habitat units from the Dormaier and Chester Butte parcels.

  5. Strain concentration at structural discontinuities and its quantification by elastic follow-up parameter

    International Nuclear Information System (INIS)

    Kasahara, Naoto; Takasho, Hideki

    1998-12-01

    Elevated temperature structural design codes pay attention to strain concentration at structural discontinuities due to creep and plasticity, since it causes to enlarge creep-fatigue damage of material. One of the difficulties to predict strain concentration is its dependency on loading, constitutive equations, and relaxation time. This study investigated fundamental mechanism of strain concentration and its main factors. It was clarified that strain concentration was caused from strain redistribution between elastic and inelastic regions, which can be quantified by the elastic follow-up parameter. As a function of inelastic strain, the elastic follow-up parameter can describe variation of strain concentration during incremental loading and relaxation process, caused by transition of strain distribution from peak strain concentration to secondary stress redistribution. Structures have their own elastic follow-up characteristics as a function of inelastic strain, which is insensitive to constitutive equations. It means that application of inelastic analysis is not difficult to obtain elastic follow-up characteristics. (author)

  6. Long-term follow-up after bariatric surgery in a national cohort.

    Science.gov (United States)

    Thereaux, J; Lesuffleur, T; Païta, M; Czernichow, S; Basdevant, A; Msika, S; Millat, B; Fagot-Campagna, A

    2017-09-01

    Lifelong medical follow-up is mandatory after bariatric surgery. The aim of this study was to assess the 5-year follow-up after bariatric surgery in a nationwide cohort of patients. All adult obese patients who had undergone primary bariatric surgery in 2009 in France were included. Data were extracted from the French national health insurance database. Medical follow-up (medical visits, micronutrient supplementation and blood tests) during the first 5 years after bariatric surgery was assessed, and compared with national and international guidelines. Some 16 620 patients were included in the study. The percentage of patients with at least one reimbursement for micronutrient supplements decreased between the first and fifth years for iron (from 27.7 to 24.5 per cent; P bariatric surgery is poor, especially for young men with poor early follow-up. © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  7. A Long-Term Follow-Up of Treatment for Severe Self-Injury.

    Science.gov (United States)

    Williams, Don E.; And Others

    1994-01-01

    Treatment of a woman with severe mental retardation with the Self-Injurious Behavior Inhibiting System (SIBIS) resulted in significant reductions in SIB behavior which generalized to the natural environment and the brief follow-up sessions. (Author/DB)

  8. ESRD QIP - Pain Assessment and Follow-up - Payment Year 2018

    Data.gov (United States)

    U.S. Department of Health & Human Services — This dataset includes facility details, measure score, and the state and national average measure scores for the pain assessment and follow up reporting measure...

  9. Postoperative follow-up studies in congenital dilatation of the common bile duct using hepatobiliary scintigraphy

    Energy Technology Data Exchange (ETDEWEB)

    Hirobe, Seiichi; Ishida, Haruo; Hayashi, Akira; Kamagata, Shoichiro; Fuchimoto, Yasufumi; Mizuno, Dai; Yano, Tsunehiro [Tokyo Metropolitan Kiyose Children`s Hospital (Japan); Ishii, Katsumi

    1995-03-01

    Follow-up studies in congenital dilatation of the common bile duct were done in 20 cases ranging 3 to 20 years after operation. Operative cholangiography had shown dilatation of the intrahepatic bile ducts in 15 patients (75%), of these, 7 patients had cystic dilatation. Five cases of these 7 patients showed prolonged stasis of the nuclide in the cystic dilated intrahepatic bile ducts by {sup 99m}Tc-PMT hepatobiliary scintigraphy in the follow-up studies even at 10 years after operation. But none of 20 cases had complication such as intrahepatic lithiasis, cholangitis, and liver dysfunction. Hepatobiliary scintigraphy could provide moderate anatomic and excellent functional information which were useful for these follow-up studies and careful follow-up should be done in the case of cystic dilatation of the intrahepatic bile ducts. (author).

  10. ESRD QIP - Clinical Depression Screening and Follow-up - Payment Year 2018

    Data.gov (United States)

    U.S. Department of Health & Human Services — This dataset includes facility details, measure score, and the state and national average measure scores for the clinical depression screening and follow up...

  11. Health status and follow-up of the liquidators in Belarus

    International Nuclear Information System (INIS)

    Okeanov, A.E.; Antipova, S.I.; Polyakov, S.M.; Sobolev, A.V.; Bazulko, N.V.; Cardis, E.

    1996-01-01

    This paper presents information on the organization of the follow-up of Chernobyl liquidators in Belarus. The characteristics of the liquidators cohort and results of preliminary analyses of their health status, including cancer incidence and general morbidity, are presented

  12. Posttreatment follow-up of radiation oncology patients in a managed care environment

    International Nuclear Information System (INIS)

    Steinberg, Michael L.; Rose, Christopher M.

    1996-01-01

    Purpose: Health care delivery in the United States is in the midst of a structural revolution called managed care. Demands for cost control within the managed care environment force radiation oncologists to defend the need and obligation to follow their patients. Methods and Materials: We have analyzed this follow-up requirement from six potential justifications: patient care, medical-legal, quality assurance, outcome measurement, cost, and improvement of care. Results: Practical recommendations for discussing the need for follow-up with the medical directors and primary care physicians of managed care entities are given. Follow-up without valid documentation of benefit is hard to justify in this era of managed care. Conclusions: Collaborative follow-up between the referring physician, the treating radiation oncologist, and the other oncologic specialists will allow for outcome measurement and improvement in practice without driving up cost or exposing the patient to undue risk.

  13. Osteogenesis imperfecta in childhood: impairment and disability--a follow-up study

    NARCIS (Netherlands)

    Engelbert, R. H.; Beemer, F. A.; van der Graaf, Y.; Helders, P. J.

    1999-01-01

    To evaluate differences over time (mean follow-up, 14 months) on impairment parameters (range of joint motion and muscle strength), functional limitation parameters (functional ability), and disability parameters (caregiver assistance in achieving functional skills) in osteogenesis imperfecta (OI),

  14. Chondrodysplasia punctata after warfarin. Case report with 18-month follow-up

    Energy Technology Data Exchange (ETDEWEB)

    Tamburrini, O.; Bartolomeo-De Iuri, A.; Di Guglielmo, G.L.

    1987-05-01

    Administration of warfarin during pregnancy may cause a rare syndrome characterized by nasal hypoplasia, usually associated with stippled epiphyseal and extraepiphyseal calcifications ressembling chondrodysplasia punctata. A case of chondrodysplasia punctata after warfarin with 18 months follow-up is reported.

  15. Nurse-led telephone follow-up after total knee arthroplasty

    DEFF Research Database (Denmark)

    Szöts, Kirsten; Konradsen, Hanne; Solgaard, Søren

    2015-01-01

    AIM AND OBJECTIVES: To generate information on how telephone follow-up consultations, structured by nursing status according to the VIPS-model, functioned after total knee arthroplasty. The objectives were to unfold the content of the telephone follow-ups according to the structure for nursing...... status and to explore the patients' views of the telephone follow-ups. BACKGROUND: The length of stay in hospital following total knee arthroplasty has fallen markedly, and patients now have to be responsible for their recovery from a very early stage. After discharge, patients may experience a variety...... Telephone follow-up was valued by total knee arthroplasties patients as representing a holistic approach and providing adequate information, counselling and support after discharge to home. Three categories were identified with regard to the patients' views: 'A means for reflection and provision of adequate...

  16. Final results of a long-term, clinical follow-up in fatty liver patients

    DEFF Research Database (Denmark)

    Dam-Larsen, Sanne; Becker, Ulrik; Franzmann, Maria-Benedicte

    2009-01-01

    OBJECTIVE: There is increasing focus on non-alcoholic fatty liver disease (NAFLD). The aim of the present study was to conduct a long-term clinical follow-up of patients with biopsy-confirmed fatty liver without inflammation or significant fibrosis (pure fatty liver), to analyse for potential risk....... All admissions, discharge diagnoses and causes of death during follow-up were collected. All surviving patients were invited to a clinical follow-up. RESULTS: The follow-up period was 20.4 and 21.0 years, respectively, for the NAFLD and alcoholic fatty liver disease (AFLD) groups. Two NAFLD patients...... of death. Patients with AFLD died primarily from cirrhosis and other alcohol-related disorders, whereas in patients with NAFLD the main causes of death were cardiovascular disease and cancer. CONCLUSIONS: For patients with pure non-alcoholic fatty liver, survival was good and independent...

  17. Treatment satisfaction with paliperidone extended-release tablets: open-label study in schizophrenia patients dissatisfied with previous antipsychotic medication

    Directory of Open Access Journals (Sweden)

    Yang FD

    2017-04-01

    Full Text Available Fu De Yang,1 Juan Li,1 Yun Long Tan,1 Wei Ye Liang,1 Rongzhen Zhang,1 Ning Wang,1 Wei Feng,1 Shangli Cai,2 Jian Min Zhuo,2 Li Li Zhang2 1Beijing Hui-Long-Guan Hospital, 2Department of Medical Affairs, Xian Janssen Pharmaceutical Ltd, Beijing, People’s Republic of China Objective: The aim of this study was to evaluate the changes in treatment satisfaction after switching to paliperidone extended-release (ER in Chinese schizophrenia patients dissatisfied with their previous antipsychotic treatment.Methods: In this 8-week, open-label, single-arm, multicenter, prospective study, 1,693 patients dissatisfied with previous antipsychotic medication were enrolled and switched to paliperidone ER tablets (3–12 mg/d based on clinical judgment. The primary efficacy end point was change in Medication Satisfaction Questionnaire (MSQ score from baseline to week 8. The secondary end points included percentage of patients with MSQ score ≥4, as well as changes in Clinical Global Improvement-Severity (CGI-S and Personal and Social Performance (PSP scores.Results: MSQ scores increased significantly from baseline (mean [standard deviation {SD}]: 2.48 [0.55] to week 8 (5.47 [0.89], P<0.0001; primary end point, full analysis set. The percentage of patients with MSQ score ≥4 was 95.9% at week 8, indicating that most of the patients were satisfied with their treatment. Significant (P<0.0001 improvements from baseline to week 8 were noted in CGI-S score (2.37 [1.20] and PSP score (25.5 [15.0]. A total of 174 (10.28% patients experienced adverse events (AEs. The most common (>10 patients events were extrapyramidal disorder (n=84, 4.96%, poor quality sleep (n=18, 1.06% and akathisia (n=13, 0.77%. The majority of AEs were mild to moderate in severity. No deaths occurred.Conclusion: Treatment satisfaction improved after switching to paliperidone ER from the previous antipsychotic in Chinese patients with schizophrenia. Keywords: atypical antipsychotics, open label

  18. Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study

    Directory of Open Access Journals (Sweden)

    Sasaki T

    2014-01-01

    Full Text Available Tsuyoshi Sasaki,1,2 Kenji Hashimoto,3 Masumi Tachibana,1 Tsutomu Kurata,1 Keiko Okawada,1 Maki Ishikawa,1 Hiroshi Kimura,2 Hideki Komatsu,2 Masatomo Ishikawa,2 Tadashi Hasegawa,2 Akihiro Shiina,1 Tasuku Hashimoto,2 Nobuhisa Kanahara,3 Tetsuya Shiraishi,2 Masaomi Iyo1–31Department of Child Psychiatry, Chiba University Hospital, 2Department of Psychiatry, Chiba University Graduate School of Medicine, 3Division of Clinical Neuroscience, Chiba University Center for Forensic Mental Health, Chiba, JapanBackground: Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine has been used solely as a nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults has already been established. It is reported that tipepidine inhibits G-protein-coupled inwardly rectifying potassium (GIRK-channel currents. The inhibition of GIRK channels by tipepidine is expected to modulate the level of monoamines in the brain. We put forward the hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK channels. The purpose of this open-label trial was to confirm whether treatment with tipepidine can improve symptoms in pediatric patients with ADHD.Subjects and methods: This was a 4-week, open-label, proof-of-efficacy pilot study for pediatric subjects with ADHD. Ten pediatric ADHD subjects (70% male; mean age, 9.9 years; combined [inattentive and hyperactive/impulsive] subtype, n=7; inattentive subtype, n=3; hyperimpulsive subtype, n=0 received tipepidine hibenzate taken orally at 30 mg/day for 4 weeks. All subjects were assessed using the ADHD Rating Scale IV (ADHD-RS, Japanese version, and the Das–Naglieri Cognitive Assessment System (DN-CAS, Japanese version.Results: A comparison of baseline scores and 4-week end-point scores showed that all the ADHD-RS scores (total scores, hyperimpulsive subscores, and inattentive subscores

  19. Early Primary Care Provider Follow-up and Readmission After High-Risk Surgery

    Science.gov (United States)

    Brooke, Benjamin S.; Stone, David H.; Cronenwett, Jack L.; Nolan, Brian; DeMartino, Randall R.; MacKenzie, Todd A.; Goodman, David C.; Goodney, Philip P.

    2014-01-01

    IMPORTANCE Follow-up with a primary care provider (PCP) in addition to the surgical team is routinely recommended to patients discharged after major surgery despite no clear evidence that it improves outcomes. OBJECTIVE To test whether PCP follow-up is associated with lower 30-day readmission rates after open thoracic aortic aneurysm (TAA) repair and ventral hernia repair (VHR), surgical procedures known to have a high and low risk of readmission, respectively. DESIGN, SETTING, AND PARTICIPANTS In a cohort of Medicare beneficiaries discharged to home after open TAA repair (n = 12 679) and VHR (n = 52 807) between 2003 to 2010, we compared 30-day readmission rates between patients seen and not seen by a PCP within 30 days of discharge and across tertiles of regional primary care use. We stratified our analysis by the presence of complications during the surgical (index) admission. MAIN OUTCOMES AND MEASURES Thirty-day readmission rate. RESULTS Overall, 2619 patients (20.6%) undergoing open TAA repair and 4927 patients (9.3%) undergoing VHR were readmitted within 30 days after surgery. Complications occurred in 4649 patients (36.6%) undergoing open TAA repair and 4528 patients (8.6%) undergoing VHR during their surgical admission. Early follow-up with a PCP significantly reduced the risk of readmission among open TAA patients who experienced perioperative complications, from 35.0% (without follow-up) to 20.4% (with follow-up) (P < .001). However, PCP follow-up made no significant difference in patients whose hospital course was uncomplicated (19.4% with follow-up vs 21.9% without follow-up; P = .31). In comparison, early follow-up with a PCP after VHR did not reduce the risk of readmission, regardless of complications. In adjusted regional analyses, undergoing open TAA repair in regions with high compared with low primary care use was associated with an 18% lower likelihood of 30-day readmission (odds ratio, 0.82; 95% CI, 0.71–0.96; P = .02), whereas no significant

  20. Electronic Detection of Delayed Test Result Follow-Up in Patients with Hypothyroidism.

    Science.gov (United States)

    Meyer, Ashley N D; Murphy, Daniel R; Al-Mutairi, Aymer; Sittig, Dean F; Wei, Li; Russo, Elise; Singh, Hardeep

    2017-07-01

    Delays in following up abnormal test results are a common problem in outpatient settings. Surveillance systems that use trigger tools to identify delayed follow-up can help reduce missed opportunities in care. To develop and test an electronic health record (EHR)-based trigger algorithm to identify instances of delayed follow-up of abnormal thyroid-stimulating hormone (TSH) results in patients being treated for hypothyroidism. We developed an algorithm using structured EHR data to identify patients with hypothyroidism who had delayed follow-up (>60 days) after an abnormal TSH. We then retrospectively applied the algorithm to a large EHR data warehouse within the Department of Veterans Affairs (VA), on patient records from two large VA networks for the period from January 1, 2011, to December 31, 2011. Identified records were reviewed to confirm the presence of delays in follow-up. During the study period, 645,555 patients were seen in the outpatient setting within the two networks. Of 293,554 patients with at least one TSH test result, the trigger identified 1250 patients on treatment for hypothyroidism with elevated TSH. Of these patients, 271 were flagged as potentially having delayed follow-up of their test result. Chart reviews confirmed delays in 163 of the 271 flagged patients (PPV = 60.1%). An automated trigger algorithm applied to records in a large EHR data warehouse identified patients with hypothyroidism with potential delays in thyroid function test results follow-up. Future prospective application of the TSH trigger algorithm can be used by clinical teams as a surveillance and quality improvement technique to monitor and improve follow-up.

  1. Costs and role of ultrasound follow-up of polytrauma patients after initial computed tomography

    International Nuclear Information System (INIS)

    Maurer, M.H.; Winkler, A.; Powerski, M.J.; Elgeti, F.; Huppertz, A.; Roettgen, R.; Marnitz, T.; Wichlas, F.

    2012-01-01

    Purpose: To assess the costs and diagnostic gain of abdominal ultrasound follow-up of polytrauma patients initially examined by whole-body computed tomography (CT). Materials and Methods: A total of 176 patients with suspected multiple trauma (126 men, 50 women; age 43.5 ± 17.4 years) were retrospectively analyzed with regard to supplementary and new findings obtained by ultrasound follow-up compared with the results of exploratory FAST (focused assessment with sonography for trauma) at admission and the findings of whole-body CT. A process model was used to document the staff, materials, and total costs of the ultrasound follow-up examinations. Results: FAST yielded 26 abdominal findings (organ injury and/or free intra-abdominal fluid) in 19 patients, while the abdominal scan of whole-body CT revealed 32 findings in 25 patients. FAST had 81 % sensitivity and 100 % specificity. Follow-up ultrasound examinations revealed new findings in 2 of the 25 patients with abdominal injuries detected with initial CT. In the 151 patients without abdominal injuries in the initial CT scan, ultrasound follow-up did not yield any supplementary or new findings. The total costs of an ultrasound follow-up examination were EUR 28.93. The total costs of all follow-up ultrasound examinations performed in the study population were EUR 5658.23. Conclusion: Follow-up abdominal ultrasound yields only a low overall diagnostic gain in polytrauma patients in whom initial CT fails to detect any abdominal injuries but incurs high personnel expenses for radiological departments. (orig.)

  2. Occurrence of gastric cancer and carcinoids in atrophic gastritis during prospective long-term follow up.

    Science.gov (United States)

    Lahner, Edith; Esposito, Gianluca; Pilozzi, Emanuela; Purchiaroni, Flaminia; Corleto, Vito D; Di Giulio, Emilio; Annibale, Bruno

    2015-07-01

    Atrophic gastritis (AG) is a risk condition for gastric cancer and type I gastric carcinoids. Recent studies assessing the overall risk of gastric cancer and carcinoids in AG at long-term follow up are lacking. This study aimed to investigate in a prospective cohort of AG patients the occurrence of gastric cancer and carcinoids at long-term follow up. A total of 200 AG patients from a prospective cohort (67% female, median age 55 years) with a follow up of 7.5 (range: 4-23.4) years were included. Inclusion criteria were presence of AG and at least one follow-up gastroscopy with biopsies at ≥4 years after AG diagnosis. Follow-up gastroscopies at 4-year intervals were performed. Overall, 22 gastric neoplastic lesions were detected (crude incidence 11%). Gastric cancer was diagnosed in four patients at a median follow up of 7.2 years (crude incidence 2%). Eleven type I gastric carcinoids were detected at a median follow up of 5.1 years (crude incidence of 5.5%). In seven patients, six low-grade and one high-grade dysplasia were found. The annual incidence rate person-year were 0.25% (95% confidence interval [CI]: 0.067-0.63%), 0.43% (95% CI: 0.17-0.89%), and 0.68% (95% CI: 0.34-1.21%) for gastric cancer, dysplasia, and type I-gastric carcinoids, respectively. The incidence rates of gastric cancer and carcinoids were not different (p = 0.07). This study shows an annual incidence rate of 1.36% person-year for gastric neoplastic lesions in AG patients at long-term follow up. AG patients are similarly exposed to gastric cancer and type I gastric carcinoids.

  3. Follow-up Evaluation of Air Force Blood Donors Screening Positive for Chagas Disease

    Science.gov (United States)

    2017-08-27

    Blood Donors Screening Positive for Cbagas Disease presented at/published to Military Health System Research Symposium (Florida, 27-30 Aug 2017) in...disease upon blood donation at JBSA -Lackland 6. TITLE OF MATERIAL TO BE PUBLISHED OR PRESENTED: Follow-up evaluation of Air Force blood donors ...Designated Exempt Reviewer Follow-up evaluation of Air Force blood donors screening positive for Chagas disease Joseph Marcus1, Bryant Webber2, Leo Cropper2

  4. The value of gynecologic cancer follow-up: evidence-based ignorance?

    Science.gov (United States)

    Lajer, Henrik; Jensen, Mette B; Kilsmark, Jannie; Albæk, Jens; Svane, Danny; Mirza, Mansoor R; Geertsen, Poul F; Reerman, Diana; Hansen, Kåre; Milter, Maya C; Mogensen, Ole

    2010-11-01

    To explore the extent of evidence-based data and cost-utility of follow-up after primary treatment of endometrial and ovarian cancer, addressing perspectives of technology, organization, economics, and patients. Systematic literature searches according to the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions were conducted separately for each of the 4 perspectives. In addition, the organizational analysis included a nationwide questionnaire survey among all relevant hospital departments, and the operating costs were calculated. None of the identified studies supported a survival benefit from hospital-based follow-up after completion of primary treatment of endometrial or ovarian cancer. The methods for follow-up were of low technology (gynecologic examination with or without ultrasound examination). Other technologies had poor sensitivity and specificity in detecting recurrence. Small changes in applied technologies and organization lead to substantial changes in costs. Substantial differences especially in frequency and applied methods were found between departments. The literature review did not find evidence that follow-up affects the women's quality of life. The main purpose of follow-up after treatment of cancer is improved survival. Our review of the literature showed no evidence of a positive effect on survival in women followed up after primary treatment of endometrial or ovarian cancer. The conception of follow-up among physicians, patients, and their relatives therefore needs revision. Follow-up after treatment should have a clearly defined and evidence-based purpose. Based on the existing literature, this purpose should presently focus on other end points rather than early detection of relapse and improved survival. These end points could be quality of life, treatment toxicity, and economy.

  5. Factors Associated with Remission of Eczema in Children: a Population-based Follow-up Study.

    OpenAIRE

    von Kobyletzki, Laura; Bornehag, Carl-Gustaf; Breeze, Elizabeth; Larsson, Malin; Boman Lindström, Cecilia; Svensson, Åke

    2014-01-01

    The aim of this study was to analyse factors associated with remission of atopic dermatitis (AD) in childhood. A population-based AD cohort of 894 children aged 1-3 years from a cross-sectional baseline study in 2000 was followed up in 2005. The association between remission, background, health, lifestyle, and environmental variables was estimated with crude and multivariable logistic regression. At follow-up, 52% of the children had remission. Independent factors at baseline predicting remis...

  6. The value of gynecologic cancer follow-up: evidence-based ignorance?

    DEFF Research Database (Denmark)

    Lajer, Henrik; Jensen, Mette B; Kilsmark, Jannie

    2010-01-01

    To explore the extent of evidence-based data and cost-utility of follow-up after primary treatment of endometrial and ovarian cancer, addressing perspectives of technology, organization, economics, and patients.......To explore the extent of evidence-based data and cost-utility of follow-up after primary treatment of endometrial and ovarian cancer, addressing perspectives of technology, organization, economics, and patients....

  7. Annual Trends in Follow-Up Visits for Pediatric Concussion in Emergency Departments and Physicians' Offices.

    Science.gov (United States)

    Fridman, Liraz; Scolnik, Michal; Macpherson, Alison; Rothman, Linda; Guttmann, Astrid; Grool, Anne M; Rodriguez Duque, Daniel; Zemek, Roger L

    2018-01-01

    To assess whether children and youth with concussion receive follow-up visits in accordance with the recommended guidelines. We conducted a retrospective, population-based study using linked health administrative data from all concussion-related visits to emergency department and physician offices by children aged 5 through 18 years (range, 5.00-18.99) in Ontario between 2003 and 2013. We analyzed the percentage of children and youth seen for follow-up. The Mann-Kendall test for trends was used to assess a monotonic increasing trend over time in concussion follow-up visits. A total of 126 654 children and youth were evaluated for an index concussion visit. The number of children and youth assessed for concussion follow-up (N = 45 155) has increased significantly over time (P < .001). In 2003, 781 of 7126 patients (11.0%; 95% CI, 10.3-11.7) with an index visit for concussion had a follow-up assessment. By 2013, 6526 of 21 681 (30.1%; 95% CI, 29.5-30.7) patients received follow-up care. The proportion of children and youth receiving follow-up after an acute concussion has significantly increased between 2003 and 2013. Nevertheless, more than two-thirds of all patients do not seek medical follow-up or clearance as recommended by current concussion guidelines, suggesting that ongoing efforts to improve and monitor compliance with recommended guidelines by patients and physicians are important. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. An audit of follow-up chest radiography after coronary artery bypass graft

    Energy Technology Data Exchange (ETDEWEB)

    Karthik, S. [Department of Cardiothoracic Surgery, Yorkshire Heart Centre, Leeds General Infirmary, Leeds (United Kingdom); O' Regan, D.J. [Department of Cardiothoracic Surgery, Yorkshire Heart Centre, Leeds General Infirmary, Leeds (United Kingdom)]. E-mail: regan@leedsth.nhs.uk

    2006-07-15

    AIM: To investigate the clinical value and audit chest radiography, which is currently undertaken as part of routine practice, in the follow-up of coronary artery bypass graft (CABG) patients. MATERIAL AND METHODS: Six hundred and sixty-six first time CABG patients were identified from the Patient Analysis and Tracking System database representing the work of a single surgeon between February 2001 and September 2005. The data regarding the clinical and radiological findings on follow-up were collected from the follow-up clinic letters and case notes. Any need for re-admission/intervention was also noted. RESULTS: Of the 666 patients, 11 died and a further 10 either refused or failed to arrive for follow-up. Chest radiography was undertaken in 645 patients. Only 13 patients (2%) were found to have an abnormality on chest radiography. In all cases this was a pleural effusion that was confirmed on clinical examination in seven patients (53.9%) patients. Only one patient needed re-admission and intervention. In this case the effusion had been noted on clinical examination. Seven patients were discharged and the remaining five were followed up with repeat chest radiography before discharge. Seventy-four patients had a respiratory complication postoperatively, but only three had any evidence of an effusion on follow-up. CONCLUSION: The diagnostic yield of a routine chest radiography in a CABG follow-up clinic is low (2%) and the need for intervention is rare and is determined by clinical examination. The practice of routine radiography in this group of patients has now stopped and follow-up audit will be conducted in 12 months.

  9. Adherence to Follow-Up Recommendations by Triathlon Competitors Receiving Event Medical Care

    OpenAIRE

    Joslin, Jeremy D.; Lloyd, Jarem B.; Copeli, Nikoli; Cooney, Derek R.

    2017-01-01

    Introduction. We sought to investigate triathlete adherence to recommendations for follow-up for participants who received event medical care. Methods. Participants of the 2011 Ironman Syracuse 70.3 (Syracuse, NY) who sought evaluation and care at the designated finish line medical tent were contacted by telephone approximately 3 months after the initial encounter to measure adherence with the recommendation to seek follow-up care after event. Results. Out of 750 race participants, 35 (4.6%) ...

  10. Radiology-led Follow-up System for IVC Filters: Effects on Retrieval Rates and Times

    International Nuclear Information System (INIS)

    Lee, L.; Taylor, J.; Munneke, G.; Morgan, R.; Belli, A.-M.

    2012-01-01

    Purpose: Successful IVC filter retrieval rates fall with time. Serious complications have been reported following attempts to remove filters after 3–18 months. Failed retrieval may be associated with adverse clinical sequelae. This study explored whether retrieval rates are improved if interventional radiologists organize patient follow-up, rather than relying on the referring clinicians. Methods: Proactive follow-up of patients who undergo filter placement was implemented in May 2008. At the time of filter placement, a report was issued to the referring consultant notifying them of the advised timeframe for filter retrieval. Clinicians were contacted to arrange retrieval within 30 days. We compared this with our practice for the preceding year. Results: The numbers of filters inserted during the two time periods was similar, as were the numbers of retrieval attempts and the time scale at which they occurred. The rate of successful retrievals increased but not significantly. The major changes were better documentation of filter types and better clinical follow-up. After the change in practice, only one patient was lost to follow-up compared with six the preceding year. Conclusions: Although there was no significant improvement in retrieval rates, the proactive, radiology-led approach improved follow-up and documentation, ensuring that a clinical decision was made about how long the filter was required and whether retrieval should be attempted and ensuring that patients were not lost to follow-up.

  11. Creating the Action Model for High Risk Infant Follow Up Program in Iran.

    Science.gov (United States)

    Heidarzadeh, Mohammad; Jodiery, Behzad; Mirnia, Kayvan; Akrami, Forouzan; Hosseini, Mohammad Bagher; Heidarabadi, Seifollah; HabibeLahi, Abbas

    2013-11-01

    Intervention in early childhood development as one of the social determinants of health, is important for reducing social gap and inequity. In spite of increasingly developing intensive neonatal care wards and decreasing neonatal mortality rate, there is no follow up program in Iran. This study was carreid out to design high risk infants follow up care program with the practical aim of creating an model action for whole country, in 2012. This qualitative study has been done by the Neonatal Department of the Deputy of Public Health in cooperation with Pediatrics Health Research Center of Tabriz University of Medical Sciences, Iran. After study of international documents, consensus agreement about adapted program for Iran has been accomplished by focus group discussion and attended Delphi agreement technique. After compiling primary draft included evidence based guidelines and executive plan, 14 sessions including expert panels were hold to finalize the program. After finalizing the program, high risk infants follow up care service package has been designed in 3 chapters: Evidence based clinical guidelines; eighteen main clinical guidelines and thirteen subsidiaries clinical guidelines, executive plan; 6 general, 6 following up and 5 backup processes. Education program including general and especial courses for care givers and follow up team, and family education processes. We designed and finalized high risk infants follow up care service package. It seems to open a way to extend it to whole country.

  12. Effects of enterostomal nurse telephone follow-up on postoperative adjustment of discharged colostomy patients.

    Science.gov (United States)

    Zhang, Jun-e; Wong, Frances Kam Yuet; You, Li-ming; Zheng, Mei-chun; Li, Qiong; Zhang, Bing-yan; Huang, Man-rong; Ye, Xin-Mei; Liang, Ming-juan; Liu, Jin-ling

    2013-01-01

    People with a new colostomy encounter many difficulties as they struggle to adjust to their ostomies. Nurse telephone follow-up is a convenient way to ensure continuity of care. There is a paucity of studies testing if nurse telephone follow-up can enhance adjustment of postdischarged colostomy patients. The purpose of this study was to evaluate the effect of enterostomal nurse telephone follow-up on the adjustment levels of discharged colostomy patients. This was a randomized controlled trial. Participants (n = 103) who had undergone colostomy operations in China were recruited and randomly assigned to the study or control group. Both the study and control groups received routine discharge care, whereas the study group received 2-3 nurse telephone calls in the follow-up period. The outcome measures included Ostomy Adjustment Scale, Stoma Self-efficacy Scale, satisfaction with care, and stoma complications. Results of this study indicated that participants in the study group had significantly better ostomy adjustment, higher stoma self-efficacy, higher satisfaction with care, and less stoma complications compared with those in the control group. This study provided evidence to support that enterostomal nurse telephone follow-up can improve patient ostomy adjustment level and other related outcomes. Nurse telephone follow-up is an effective intervention to support the adjustment of stoma patients after hospital discharge.

  13. Comfort monitoring? Environmental assessment follow-up under community-industry negotiated environmental agreements

    International Nuclear Information System (INIS)

    Noble, Bram; Birk, Jasmine

    2011-01-01

    Negotiated environmental agreements are becoming common practice in the mining industry. In principle, negotiated environmental agreements are said to respond to many of the shortcomings of environmental impact assessment by providing for improved follow-up of project impacts through, among other things, data provision, engaging stakeholders in the monitoring and management of project impacts, and building capacity at the local level to deal with project-induced environmental change. In practice, however, little is known about the efficacy of follow-up under negotiated environmental agreements between proponents and communities and the demonstrated value added to project impact management. This paper examines follow-up practice under negotiated environmental agreements with a view to understanding whether and how community-based monitoring under privatized agreements actually contributes to improved follow-up and impact management. Based on lessons emerging from recent experiences with environmental agreements in Canada's uranium industry, we show that follow-up under negotiated agreements may be described as 'comfort monitoring'. While such monitoring does improve community-industry relations and enhance corporate image, it does little to support effects-based management. If follow-up under negotiated agreements is to be credible over the long term, there is a need to ensure that monitoring results are useful for, and integrated with, regulatory-based monitoring and project impact management practices.

  14. Long-term follow-up of two interventional procedures for achalasia

    International Nuclear Information System (INIS)

    Cheng Yingsheng; Li Minghua; Shang Kezhong

    2005-01-01

    Objective: To observed the long-term follow-up of the two types of interventional procedure for achalasia. Methods: The study cohort was comprised of 140 patients of achalasia including 70 patients treated under fluoroscopy with pneumatic dilation (group A) and 70 with temporary partially covered metal stent dilation (group B). Results: One hundred and forty dilations were performed on the 70 patients of group A with complications of chest pain (n=35), reflux (n=18), and bleeding (n=8); 38 patients of relapsing dysphagia during a 12-month follow-up, and 50 patients out of 60 of recurrent dysphagia during a 36-month follow-up. Seventy partially covered expandable metal stents were temporarily placed in the 70 patients of group B and withdrawn after 3-7 days via gastroscopy with complications of chest pain (n=28), reflux (n=15), and bleeding (n=9); 7 patients out of 70 exhibited dysphagia relapse during a 12-month followup, and 9 out of 58 patients exhibited dysphagia relapse during a 36-month follow-up. All the stents were inserted and withdrawn successfully. The follow-up in groups A-B lasted for 12-96 months. Conclusion: Temporary partially covered metal stent dilation is one of the best methods of interventional procedure for achalasia in long-term follow-up. (authors)

  15. Critical Care Follow-up Clinics: A Scoping Review of Interventions and Outcomes.

    Science.gov (United States)

    Lasiter, Sue; Oles, Sylwia K; Mundell, James; London, Susan; Khan, Babar

    2016-01-01

    The purpose of this scoping review is to identify evidence describing benefits of interventions provided in intensive care unit (ICU) survivor follow-up clinics. Advances in ICU treatments have increased the number of survivors who require specialized care for ICU-related sequelae. Intensive care unit survivor follow-up clinics exist, yet little is known about the nature and impact of interventions provided in such clinics. A scoping review of publications about in-person post-ICU follow-up care was undertaken. Ten databases were searched yielding 111 relevant unique publication titles and abstracts. Sample heterogeneity supported using a scoping review method. After excluding nonrelated publications, 33 reports were fully reviewed. Twenty international publications were included that described ICU follow-up clinic interventions and/or outcomes. Authors discussed very diverse interventions in 15 publications, and 9 reported some level of intervention effectiveness. Evidence was strongest that supported the use of prospective diaries as an intervention to prevent or improve psychological symptoms, whereas evidence to support implementation of other interventions was weak. Although ICU follow-up clinics exist, evidence for interventions and effectiveness of treatments in these clinics remains underexplored. Intensive care unit survivor follow-up clinics provide a venue for further interdisciplinary intervention research that could lead to better health outcomes for ICU survivors.

  16. An open-label trial of aripiprazole in the treatment of aggression in male adolescents diagnosed with conduct disorder.

    Science.gov (United States)

    Kuperman, Samuel; Calarge, Chadi; Kolar, Anne; Holman, Timothy; Barnett, Mitchell; Perry, Paul

    2011-11-01

    The adverse effect profiles of typical and atypical antipsychotics are problematic because of their extrapyramidal and endocrine adverse effects, respectively. Ten adolescent male patients diagnosed with conduct disorder received aripiprazole in doses of ≤20 mg/d in an open-label, intent-to-treat design to establish and characterize the efficacy of the drug in reducing aggressive behavior. Based on clinician and parent observations, aripiprazole was effective in reducing aggressive behavior in adolescent boys. The change in clinician-observed aggression ratings appears to have been driven by a decrease in physical aggression, whereas the change in parent-observed aggression ratings appears to have been driven by a decrease in verbal aggression and aggression against objects and animals. Aripiprazole was an effective and relatively well-tolerated treatment for overall aggression in adolescent males with conduct disorder, in the view of both clinicians and parents. Depending on the observer, aripiprazole improved aggression categorized as physical aggression, verbal aggression, and aggression against objects and animals.

  17. The efficacy of reboxetine in the treatment-refractory patients with panic disorder: an open label study.

    Science.gov (United States)

    Dannon, P N; Iancu, I; Grunhaus, L

    2002-10-01

    Selective serotonin reuptake inhibitors (SSRIs) are currently the first-line treatment for panic disorder, although up to 30% of patients either do not respond to SSRIs or withdraw due to adverse events. Reboxetine, a selective norepinephrine reuptake inhibitor (selective NRI), is effective in treating depression and may alleviate depression-related anxiety. This study aimed to investigate the efficacy of reboxetine in the treatment of patients with panic disorder who did not respond to SSRIs. In this 6-week, open-label study, 29 adult outpatients with panic disorder who had previously failed to respond to SSRI treatment received reboxetine 2 mg/day, titrated to a maximum of 8 mg/day over the first 10 days. Efficacy was assessed using the Panic Self-Questionnaire (PSQ), the Hamilton Rating Scale for Anxiety (HAM-A), the 17-item Hamilton Rating Scale for Depression (HRSD) and the Global Assessment of Functioning (GAF) Scale. The 24 patients who completed the study responded well to reboxetine treatment. Significant improvement (p < 0.001) was observed in the number of daily panic attacks, and on the scales measuring anxiety, depression and functioning. Reboxetine was generally well tolerated. Five patients withdrew due to adverse events. Reboxetine appears to be effective in the treatment of SSRI-refractory panic disorder patients and warrants further clinical investigation. Copyright 2002 John Wiley & Sons, Ltd.

  18. Simvastatin as an Adjunct to Conventional Therapy of Non-infectious Uveitis: A Randomized, Open-Label Pilot Study.

    Science.gov (United States)

    Shirinsky, Ivan V; Biryukova, Anastasia A; Shirinsky, Valery S

    2017-12-01

    Statins have been shown to reduce ocular inflammation in animal models of uveitis and to prevent development of uveitis in observational studies. There have been no experimental human studies evaluating statins' efficacy and safety in uveitis. In this study, we aimed to investigate efficacy and safety of simvastatin in patients with uveitis. For this single-center, open-label, randomized study, we enrolled patients with acute non-infectious uveitis. The patients were randomized to receive 40 mg simvastatin per day for 2 months in addition to conventional treatment or conventional treatment alone. The studied outcomes were the rate of steroid-sparing control of ocular inflammation, measures of ocular inflammation, intraocular pressure, and visual acuity. Fifty patients were enrolled in the study. Twenty-five patients were randomly assigned to receive simvastatin with conventional treatment and 25 to conventional treatment alone. Simvastatin was associated with significantly higher rates of steroid-sparing ocular inflammation control, decrease in anterior chamber inflammation, and improvement in visual acuity. The treatment was well tolerated, no serious adverse effects were observed. Our findings suggest that statins may have therapeutic potential in uveitis. These results need to be confirmed in double-blind, randomized, controlled studies.

  19. Continuing weight-loss effect after topiramate discontinuation in obese persons with schizophrenia: a pilot open-label study.

    Science.gov (United States)

    Liang, C-S; Yang, F-W; Huang, S-Y; Ho, P-S

    2014-07-01

    Few studies have investigated the likelihood of weight maintenance in obese persons with schizophrenia after their initial successful weight loss. This pilot open-label study examined the efficacy of topiramate in weight loss and the trajectory of weight changes after topiramate discontinuation. This study enrolled 10 obese persons with schizophrenia. A 4-month treatment phase was started, followed by a 12-month discontinuation phase. Body weight was measured as the primary outcome every month. Secondary outcomes included leptin levels, fasting glucose, lipid profiles, and insulin resistance index. After the 4-month addition of topiramate, participants lost 1.79 kg of their body weight (95% CI=-3.03 to -0.56, p=0.005). The maximum weight reduction was 4.32 kg, occurring when topiramate had been discontinued for 12 months (95% CI=-6.41 to -2.24, p<0.001). The continuing weight-loss effect after topiramate discontinuation might have resulted from topiramate's potential to improve leptin functioning. These findings demonstrate that topiramate's weight-loss effect could not only persist during its administration, but also continue to improve after its discontinuation. © Georg Thieme Verlag KG Stuttgart · New York.

  20. Effects of risperidone on core symptoms of autistic disorder based on childhood autism rating scale: an open label study.

    Science.gov (United States)

    Ghaeli, Padideh; Nikvarz, Naemeh; Alaghband-Rad, Javad; Alimadadi, Abbas; Tehrani-Doost, Mehdi

    2014-01-01

    The aim of the present study was to evaluate the effect of risperidone in patients afflicted by autistic disorder especially with regards to its three core symptoms, including "relating to others", "communication skills", and "stereotyped behaviors" based on Childhood Autism Rating Scale (CARS). An 8-week open-label study of risperidone for treatment of autistic disorder in children 4-17 years old was designed. Risperidone dose titration was as follow: 0.02 mg/kg/day at the first week, 0.04 mg/kg/day at the second week, and 0.06 mg/kg/day at the third week and thereafter. The outcome measures were scores obtained by CARS, Aberrant Behavior Checklist (ABC), and Clinical Global Impression-Improvement (CGI-I) scale. Fifteen patients completed this study. After 8 weeks, CARS total score decreased significantly, (P=0.001). At the end of the study, social interactions and verbal communication skills of the patients were significantly improved (Pautistic disorder.

  1. Onabotulinumtoxin A Treatment of Drooling in Children with Cerebral Palsy: A Prospective, Longitudinal Open-Label Study

    DEFF Research Database (Denmark)

    Møller, Eigild; Pedersen, Søren Anker; Vinicoff, Pablo Gustavo

    2015-01-01

    The aim of this prospective open-label study was to treat disabling drooling in children with cerebral palsy (CP) with onabotulinumtoxin A (A/Ona, Botox®) into submandibular and parotid glands and find the lowest effective dosage and least invasive method. A/Ona was injected in 14 children, Mean...... age 9 years, SD 3 years, under ultrasonic guidance in six successive Series, with at least six months between injections. Doses and gland involvement increased from Series A to F (units (U) per submandibular/parotid gland: A, 10/0; B, 15/0; C, 20/0; D, 20/20; E, 30/20; and F, 30/30). The effect...... in E and F, but with swallowing problems ≤5 weeks in 3 of 28 treatments. F had largest VAS and UWS reduction (64% and 49%). We recommend: Start with dose D A/Ona (both submandibular and parotid glands and a total of 80 U) and increase to E and eventually F (total 120 U) without sufficient response....

  2. Effectiveness of hydrogen rich water on antioxidant status of subjects with potential metabolic syndrome-an open label pilot study.

    Science.gov (United States)

    Nakao, Atsunori; Toyoda, Yoshiya; Sharma, Prachi; Evans, Malkanthi; Guthrie, Najla

    2010-03-01

    Metabolic syndrome is characterized by cardiometabolic risk factors that include obesity, insulin resistance, hypertension and dyslipidemia. Oxidative stress is known to play a major role in the pathogenesis of metabolic syndrome. The objective of this study was to examine the effectiveness of hydrogen rich water (1.5-2 L/day) in an open label, 8-week study on 20 subjects with potential metabolic syndrome. Hydrogen rich water was produced, by placing a metallic magnesium stick into drinking water (hydrogen concentration; 0.55-0.65 mM), by the following chemical reaction; Mg + 2H(2)O --> Mg (OH)(2) + H(2). The consumption of hydrogen rich water for 8 weeks resulted in a 39% increase (pfasting glucose levels during the 8 week study. In conclusion, drinking hydrogen rich water represents a potentially novel therapeutic and preventive strategy for metabolic syndrome. The portable magnesium stick was a safe, easy and effective method of delivering hydrogen rich water for daily consumption by participants in the study.

  3. Use of Vitex agnus-castus in migrainous women with premenstrual syndrome: an open-label clinical observation.

    Science.gov (United States)

    Ambrosini, Anna; Di Lorenzo, Cherubino; Coppola, Gianluca; Pierelli, Francesco

    2013-03-01

    Premenstrual syndrome (PMS) affects most women during their reproductive life. Headache is regarded as a typical symptom of PMS and, close to menses, migrainous women could experience their worst migraine attacks. Vitex agnus-castus (VAC) is a phytopharmaceutical compound, considered worldwide to be a valid tool to treat PMS. Aim of this study is to explore if headache is ameliorate in migrainous women treated with VAC for PMS by an open-label clinical observation. Migrainous women with PMS were enrolled in the study and advised to assume a treatment with VAC (40 mg/day) for PMS for a 3-month period. Effects both on PMS and headache were assessed. Out of 107 women, 100 completed the 3-month treatment for PMS. Out of them, 66 women reported a dramatic reduction of PMS symptoms, 26 a mild reduction, and 8 no effect. Concerning migraine, 42 % of patients experienced a reduction higher than 50 % in frequency of monthly attacks, and 57 % of patients experienced a reduction higher than 50 % in monthly days with headache. No patients reported remarkable side effects. Pending a placebo-controlled trial to confirm our results, we observed that the use of VAC in migrainous women affected by PMS resulted to be safe and well tolerated, and may positively influence the frequency and duration of migraine attacks.

  4. Effect of Facial Cosmetic Acupuncture on Facial Elasticity: An Open-Label, Single-Arm Pilot Study

    Directory of Open Access Journals (Sweden)

    Younghee Yun

    2013-01-01

    Full Text Available Background. The use of acupuncture for cosmetic purposes has gained popularity worldwide. Facial cosmetic acupuncture (FCA is applied to the head, face, and neck. However, little evidence supports the efficacy and safety of FCA. We hypothesized that FCA affects facial elasticity by restoring resting mimetic muscle tone through the insertion of needles into the muscles of the head, face, and neck. Methods. This open-label, single-arm pilot study was implemented at Kyung Hee University Hospital at Gangdong from August through September 2011. Participants were women aged 40 to 59 years with a Glogau photoaging scale III. Participants received five treatment sessions over three weeks. Participants were measured before and after FCA. The primary outcome was the Moire topography criteria. The secondary outcome was a patient-oriented self-assessment scale of facial elasticity. Results. Among 50 women screened, 28 were eligible and 27 completed the five FCA treatment sessions. A significant improvement after FCA treatment was evident according to mean change in Moire topography criteria (from 1.70 ± 0.724 to 2.26 ± 1.059, P<0.0001. The most common adverse event was mild bruising at the needle site. Conclusions. In this pilot study, FCA showed promising results as a therapy for facial elasticity. However, further large-scale trials with a controlled design and objective measurements are needed.

  5. Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol.

    Science.gov (United States)

    Rosenberg, Evan C; Louik, Jay; Conway, Erin; Devinsky, Orrin; Friedman, Daniel

    2017-08-01

    Recent clinical trials indicate that cannabidiol (CBD) may reduce seizure frequency in pediatric patients with certain forms of treatment-resistant epilepsy. Many of these patients experience significant impairments in quality of life (QOL) in physical, mental, and social dimensions of health. In this study, we measured the caregiver-reported Quality of Life in Childhood Epilepsy (QOLCE) in a subset of patients enrolled in a prospective, open-label clinical study of CBD. Results from caregivers of 48 patients indicated an 8.2 ± 9.9-point improvement in overall patient QOLCE (p < 0.001) following 12 weeks of CBD. Subscores with improvement included energy/fatigue, memory, control/helplessness, other cognitive functions, social interactions, behavior, and global QOL. These differences were not correlated to changes in seizure frequency or adverse events. The results suggest that CBD may have beneficial effects on patient QOL, distinct from its seizure-reducing effects; however, further studies in placebo-controlled, double-blind trials are necessary to confirm this finding. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  6. Cannabis (medical marijuana) treatment for motor and non-motor symptoms of Parkinson disease: an open-label observational study.

    Science.gov (United States)

    Lotan, Itay; Treves, Therese A; Roditi, Yaniv; Djaldetti, Ruth

    2014-01-01

    The use of cannabis as a therapeutic agent for various medical conditions has been well documented. However, clinical trials in patients with Parkinson disease (PD) have yielded conflicting results. The aim of the present open-label observational study was to assess the clinical effect of cannabis on motor and non-motor symptoms of PD. Twenty-two patients with PD attending the motor disorder clinic of a tertiary medical center in 2011 to 2012 were evaluated at baseline and 30 minutes after smoking cannabis using the following battery: Unified Parkinson Disease Rating Scale, visual analog scale, present pain intensity scale, Short-Form McGill Pain Questionnaire, as well as Medical Cannabis Survey National Drug and Alcohol Research Center Questionnaire. Mean (SD) total score on the motor Unified Parkinson Disease Rating Scale score improved significantly from 33.1 (13.8) at baseline to 23.2 (10.5) after cannabis consumption (t = 5.9; P effects of the drug were observed. The study suggests that cannabis might have a place in the therapeutic armamentarium of PD. Larger, controlled studies are needed to verify the results.

  7. A prospective, open-label study of low-dose total skin electron beam therapy in mycosis fungoides

    DEFF Research Database (Denmark)

    Kamstrup, Maria R; Specht, Lena; Skovgaard, Gunhild L

    2008-01-01

    causes and did not complete treatment. Acute side effects included desquamation, xerosis, and erythema of the skin. No severe side effects were observed. CONCLUSION: Low-dose total skin electron beam therapy can induce complete and partial responses in Stage IB-II mycosis fungoides; however, the duration......PURPOSE: To determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of Stage IB-II mycosis fungoides in a prospective, open-label study. METHODS AND MATERIALS: Ten patients (6 men, 4 women, average age 68.7 years [range, 55-82 years......]) with histopathologically confirmed mycosis fungoides T2-T4 N0-N1 M0 who did not achieve complete remission or relapsed within 4 months after treatment with psoralen plus ultraviolet-A were included. Treatment consisted of low-dose total skin electron beam therapy administered at a total skin dose of 4 Gy given in 4...

  8. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial.

    Science.gov (United States)

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-06-07

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism.

  9. Effect of mouth cleaning with hinokitiol-containing gel on oral malodor: a randomized, open-label pilot study.

    Science.gov (United States)

    Iha, Kosaku; Suzuki, Nao; Yoneda, Masahiro; Takeshita, Toru; Hirofuji, Takao

    2013-10-01

    The aim of the study was to evaluate the effect of mouth cleaning with hinokitiol-containing gel on oral malodor. An open-label, randomized, controlled trial was conducted to assess oral malodor and clinical parameters related to oral malodor before and after mouth cleaning with hinokitiol-containing gel (n = 9) or with gel not including hinokitiol (n = 9). Mouth cleaning included the teeth, gingiva, and tongue and was carried out 3 times per day for 4 weeks. Organoleptic test (OLT) scores (P = .021), levels of hydrogen sulfide (P = .008) and methyl mercaptan (P = .020), frequency of bleeding on probing, average probing pocket depth, and plaque index significantly improved in the group using hinokitiol. In contrast, only the OLT score (P = .031) significantly improved in the control group after the treatment regimen. Mouth cleaning with hinokitiol-containing gel may be effective for reduction of oral malodor. Copyright © 2013 Elsevier Inc. All rights reserved.

  10. Genealogical databases as a tool for extending follow-up in clinical reviews.

    Science.gov (United States)

    Ho, Thuy-Van; Chowdhury, Naweed; Kandl, Christopher; Hoover, Cindy; Robinson, Ann; Hoover, Larry

    2016-08-01

    Long-term follow-up in clinical reviews often presents significant difficulty with conventional medical records alone. Publicly accessible genealogical databases such as Ancestry.com provide another avenue for obtaining extended follow-up and added outcome information. No previous studies have described the use of genealogical databases in the follow-up of individual patients. Ancestry.com, the largest genealogical database in the United States, houses extensive demographic data on an increasing number of Americans. In a recent retrospective review of esthesioneuroblastoma patients treated at our institution, we used this resource to ascertain the outcomes of patients otherwise lost to follow-up. Additional information such as quality of life and supplemental treatments the patient may have received at home was obtained through direct contact with living relatives. The use of Ancestry.com resulted in a 25% increase (20 months) in follow-up duration as well as incorporation of an additional 7 patients in our study (18%) who would otherwise not have had adequate hospital chart data for inclusion. Many patients within this subset had more advanced disease or were remotely located from our institution. As such, exclusion of these outliers can impact the quality of subsequent outcome analysis. Online genealogical databases provide a unique resource of public information that is acceptable to institutional review boards for patient follow-up in clinical reviews. Utilization of Ancestry.com data led to significant improvement in follow-up duration and increased the number of patients with sufficient data that could be included in our retrospective study. © 2016 ARS-AAOA, LLC.

  11. Use of imaging during symptomatic follow-up after resection of pancreatic ductal adenocarcinoma.

    Science.gov (United States)

    Groot, Vincent P; Daamen, Lois A; Hagendoorn, Jeroen; Borel Rinkes, Inne H M; van Santvoort, Hjalmar C; Molenaar, I Quintus

    2018-01-01

    Controversy exists whether follow-up after resection of pancreatic ductal adenocarcinoma (PDAC) should include standardized imaging for the detection of disease recurrence. The purpose of this study was to evaluate how often patients undergo imaging in a setting where routine imaging is not performed. Secondly, the pattern, timing, and treatment of recurrent PDAC were assessed. This was a post hoc analysis of a prospective database of all consecutive patients undergoing pancreatic resection of PDAC between January 2011 and January 2015. Data on imaging procedures during follow-up, recurrence location, and treatment for recurrence were extracted and analyzed. Associations between clinical characteristics and post-recurrence survival were assessed with the log-rank test and Cox univariable and multivariable proportional hazards models. A total of 85 patients were included. Seventy-four patients (87%) underwent imaging procedures during follow-up at least once, with a mean amount of 3.1 ± 1.9 imaging procedures during the entire follow-up period. Sixty-eight patients (80%) were diagnosed with recurrence, 58 (85%) of whom after the manifestation of clinical symptoms. Additional tumor-specific treatment was administered in 17 of 68 patients (25%) with recurrence. Patients with isolated local recurrence, treatment after recurrence, and a recurrence-free survival >10 mo had longer post-recurrence survival. Even though a symptomatic follow-up strategy does not include routine imaging, the majority of patients with resected PDAC underwent additional imaging procedures during their follow-up period. Further prospective studies are needed to determine the actual clinical value, psychosocial implications, and cost-effectiveness of different forms of follow-up after resection of PDAC. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Follow-up CT Evaluation of the Mural Changes in Active Takayasu Arteritis

    International Nuclear Information System (INIS)

    Kim, Sang Young; Park, Jae Hyung; Chung, Jin Wook; Kim, Hyo Cheol; Lee, Whal; So, Young Ho; Jae, Hwan Jun

    2007-01-01

    We wanted to evaluate the mural changes by CT on the follow-up examination of patients with active Takayasu arteritis. The study included 18 patients, (4 males and 14 females), with active Takayasu arteritis. A total of 44 CT examinations were done during the follow-up period (mean: 55.6 months). At the time of the last follow-up CT, the disease, on the basis of the erythrocyte sedimentation rate (ESR), was found to be inactive in five patients and the disease was active and persistent in 13 patients. The thickness and CT attenuation of the aortic wall on the precontrast, arterial and venous phases were measured on the initial and the follow-up CT examinations. The ratio of the mural attenuation over that of the back muscle on the initial CT was compared with the ratio found on the follow-up CT. The initial CT findings included high density and calcifications of the aortic wall in the precontrast images and a thickened wall with enhancements in the arterial and the venous phases. A low-attenuation ring was demonstrated in the venous phase in 15 patients (83%). On the follow-up evaluation, the mean mural thickness decreased significantly from 4.1 mm to 2.4 mm. The mean mural attenuation ratio in the venous phase decreased significantly from 1.9 to 1.3 (p 0.001). The low attenuation ring was identified in seven patients (39%) who had only with active, persistent Takayasu arteritis. The mural changes demonstrated by the follow-up CT evaluations for the patients with active Takayasu arteritis included a decrease of the mural thickness and enhancement, disappearance of the low-attenuation ring on the venous phase, and an increase of the mural attenuation and calcification on the precontrast phase

  13. Functional recovery of patients with ischemic cardiomyopathy treated with coronary artery bypass surgery and concomitant intramyocardial bone marrow mononuclear cell implantation: A long term follow-up study

    Directory of Open Access Journals (Sweden)

    Trifunović Zoran

    2015-01-01

    Full Text Available Background/Aim. Intramyocardial bone marrow mononuclear cells (BMMNC implantation concomitant to coronary artery bypass grafting (CABG surgery as an option for regenerative therapy in chronic ischemic heart failure was tested in a very few number of studies, with not consistent conclusions regarding improvement in left ventricular function, and with a follow-up period between 6 months and 1 year. This study was focused on testing of the hypothesis that intramyocardial BMMNC implantation, concomitant to CABG surgery in ischemic cardiomyopathy patients, leads to better postoperative long-term results regarding the primary endpoint of conditional status-functional capacity and the secondary endpoint of mortality than CABG surgery alone in a median follow-up period of 5 years. Methods. A total of 30 patients with ischemic cardiomyopathy and the median left ventricular ejection fraction (LVEF of 35.9 ± 4.7% were prospectively and randomly enrolled in a single center interventional, open labeled clinical trial as two groups: group I of 15 patients designated as the study group to receive CABG surgery and intramyocardial implantation of BMMNC and group II of 15 patients as the control group to receive only the CABG procedure. All the patients in both groups received the average of 3.4 ± 0.7 implanted coronary grafts, and all of them received the left internal mammary artery (LIMA to the left anterior descending (LAD and autovenous to other coronaries. Results. The group with BMMNC and CABG had the average of 17.5 ± 3.8 injections of BMMNC suspension with the average number of injected bone marrow mononuclear cells of 70.7 ± 32.4 × 106 in the total average volume of 5.7 ± 1.5 mL. In this volume the average count of CD34+ and CD133+ cells was 3.96 ± 2.77 × 106 and 2.65 ± 1.71 × 106, respectively. All the patients were followed up in 2.5 to 7.5 years (median, 5 years. At the end of the follow-up period, significantly more patients from the group

  14. Efficacy of two-month treatment with Xiloial eyedrops for discomfort from disposable soft contact lenses.

    Science.gov (United States)

    Versura, Piera; Profazio, Vincenzo; Balducci, Nicole; Campos, Emilio C

    2010-09-20

    To evaluate the efficacy and tolerability of Xiloial(®) monodose eyedrops in the treatment of patients suffering from subjective symptoms of discomfort related to disposable soft contact lens (dSCL) wear. Fifteen (12 female, three male, medium age 39 ± 9 years) dSCL wearers were enrolled. Inclusion criteria were Ocular Surface Disease Index (ODSI) symptom questionnaire score >12, tear film break-up time (TFBUT) 10 mm over five minutes, mild punctuate keratopathy, and conjunctival staining (Oxford grading ≤4). Monodose Xiloial eyedrops were administered three times daily for a two-month period. Patients were evaluated at enrollment, after three days of washout (baseline), and after one and two months of treatment, by OSDI score, Schirmer test I, TFBUT, ferning test, ocular surface damage (Oxford grade), and serum albumin in tears (index of passive exudation related to serum leakage). At endpoint versus baseline, respectively, the mean ± standard deviation of all variables improved as follows: OSDI (8.5 ± 3 versus 20.2 ± 1.6); TFBUT (9.6 ± 1.1 versus 7.1 ± 1.0); Oxford grading (0.5 ± 0.1 versus 3.6 ± 0.8); ferning test (2 ± 1 versus 2.4 ± 0.5); and Schirmer test I (14.6 ± 1.1 versus 12 ± 2.1), with P < 0.05 for all variables (Friedman and Wilcoxon tests). Tolerability was high, with no adverse events noted. A two-month treatment with Xiloial showed good tolerance and appeared to reduce ocular surface damage and symptoms of discomfort.

  15. Effects of two months training on blood lactate levels in adolescent swimmers

    Directory of Open Access Journals (Sweden)

    T Atan

    2010-06-01

    Full Text Available The aim of this study is to examine the effects of two months swimming training on aerobic and anaerobic capacities with blood lactate. A total of 17 adolescent male swimmers (15.17±0.81 years were included in the study. The first measurement was conducted 1.5 months after the beginning of the season and this was followed by a second measurement conducted two months after the first measurement. A test protocol of 8x100 m crawl style was applied in the measurements and the subjects swam from slow to fast at five different swimming workloads. Between each training run, blood samples were provided from the earlobes of the subjects in order to measure the amount of blood lactate. Heart rate was measured after five swims. Furthermore, swimming styles and duration were recorded in order to calculate the swimming speed of each subject at each swimming workload. The comparison of blood lactate and speed values of all subjects before and after the training season revealed that lactate acid values had not changed significantly (p>0.05 at the lowest swimming workload (75% and that the speed had significantly increased (p<0.01. As for the rest of the swimming workloads, both lactate acid and speed increased significantly (p<0.05 and p<0.01. Our two month training programme dwelt heavily upon anaerobic training and accordingly aerobic capacity decreased and anaerobic capacity increased at higher speeds. On the other hand, in our study, we found out that anaerobic capacity had not increased only at the 75% workload and that it had decreased at the rest of the workloads.

  16. Telemedicine in the management of non-acute headaches: A prospective, open-labelled non-inferiority, randomised clinical trial.

    Science.gov (United States)

    Müller, Kai I; Alstadhaug, Karl B; Bekkelund, Svein I

    2017-08-01

    Objectives We determined headache patients' satisfaction with telemedicine and assessed how telemedicine influenced headache burden, compliance with diagnosis and treatment, and need for follow-up consultations. Methods During 2.5 years, patients from Northern Norway referred with non-acute headaches for a specialist consultation at Tromsø University Hospital were consecutively randomised to either telemedicine or traditional visits. Baseline data were recorded and compared to data from a three-month follow-up questionnaire (see Supplementary material). The following were evaluated: (1) satisfaction with the consultation; (2) headache status; subjective improvement, average pain intensity, treatment, headache days per month, and Headache Impact Test (HIT-6); and (3) treatment compliance and follow-up visits. Results Out of 402 consultations, 348 (86.6%) answered the questionnaire. Satisfaction was similar in the telemedicine and the traditional group (88.8% vs. 92.3%; p = 0.35). Subgroup analyses were not prespecified, but there were no differences in satisfaction among females, migraineurs, rural patients and urban patients. Improvement from baseline after three months was reported equally in the telemedicine and the traditional groups. There were also no differences in treatment compliance, but rural telemedicine patients had less-frequent headache visits at three months' follow-up (28.9% vs. 48.7%, p = 0.002). Conclusion Telemedicine is non-inferior to traditional consultations in patient satisfaction, specialist evaluation, and treatment of non-acute headaches. ClinicalTrials.gov ID: NCT02270177.

  17. Duloxetine in the long-term management of diabetic peripheral neuropathic pain: An open-label, 52-week extension of a randomized controlled clinical trial.

    Science.gov (United States)

    Wernicke, Joachim F; Raskin, Joel; Rosen, Amy; Pritchett, Yili L; D'Souza, Deborah N; Iyengar, Smriti; Knopp, Kelly; Le, Trong K

    2006-09-01

    data was collected at weeks 4 and 52, and glycosylated hemoglobin and lipid profile data were collected at weeks 20 and 52. Hematology and urinalysis laboratory assessments and diabetic complication assessments were done at week 52. All safety data was assessed in cases of early discontinuation. Treatment differences on quality of life (QOL) were compared using the Short Form-36 Health Status Survey (SF-36) and the EQ-5D instrument of the European Health-Related Quality of Life Measures. This was assessed at the last visit or at early discontinuation. The open-label extension-phase study included 337 patients (duloxetine, n = 222; routine care, n = 115). For the duloxetine group, mean age was 60.2 years, 61.3% were male, and 78.4% were white. For the routine-care group, mean age was 58.9 years, 60.0% were male, and 74.8% were white. Mean weight was 95.3 kg for both groups. None of the TEAEs occurred significantly more often in the duloxetine-treated group than in the routine-care-treated group. No TEAEs were reported by >10% of patients in the duloxetine group. The TEAEs reported by >10% of patients in the routine-care group included dizziness (11.3%), somnolence (13.0%), headache (10.4%), and vomiting (10.4%). No significant differences were found between treatment groups in the occurrence of serious AEs or in the number of patients discontinuing because of AEs. Duloxetine was significantly better than routine care on the bodily pain subscale of the SF-36 (mean change: 1.5 vs -4.1; P= 0.021) and on the EQ-5D (mean change: -0.00 vs -0.09; P = 0.001). Over 52 weeks of follow-up, treatment of these diabetic patients with duloxetine for peripheral neuropathic pain was associated with outcomes similar to, or significantly better than, that of routine care on most measures of tolerability, diabetic complications, and QOL.

  18. Value of early follow-up CT in paediatric tuberculous meningitis

    International Nuclear Information System (INIS)

    Andronikou, Savvas; Wieselthaler, Nicky; Smith, Bruce; Douis, Hassan; Fieggen, A. Graham; Toorn, Ronald van; Wilmshurst, Jo

    2005-01-01

    The value of CT in the diagnosis of tuberculous meningitis (TBM) in children is well reported. Follow-up CT scanning for these patients is, however, not well described and, in particular, the value of early follow-up CT has not been addressed for children with TBM. To assess the value of early follow-up CT in children with TBM in identifying diagnostic, prognostic and therapeutically relevant features of TBM. A retrospective 4-year review of CT scans performed within 1 week and 1 month of initial CT in children with proven (CSF culture-positive) and probable TBM (CSF profile-positive but culture-negative) and comparison with initial CT for the diagnostic, prognostic and therapeutic CT features of TBM. The CT scans of 50 children were included (19 ''definite'' TBM; 31 ''probable'' TBM). Of these, 30 had CT scans performed within 1 week of the initial CT. On initial CT, 44 patients had basal enhancement. Only 24 patients had contrast medium-enhanced follow-up scans. Important findings include: 8 of 29 patients (who were not shunted) developed new hydrocephalus. New infarcts developed in 24 patients; 45% of those who did not have infarction initially developed new infarcts. Three of the six patients who did not show basal enhancement on initial scans developed this on the follow-up scans, while in seven patients with pre-existing basal enhancement this became more pronounced. Two patients developed hyperdensity in the cisterns on non-contrast medium scans. Eight patients developed a diagnostic triad of features. Three patients developed CT features of TBM where there was none on the initial scans. Early follow-up CT is useful in making a diagnosis of TBM by demonstrating features that were not present initially and by demonstrating more sensitive, obvious or additional features of TBM. In addition, follow-up CT is valuable as a prognostic indicator as it demonstrates additional infarcts which may have developed or become more visible since the initial study. Lastly

  19. Value of early follow-up CT in paediatric tuberculous meningitis

    Energy Technology Data Exchange (ETDEWEB)

    Andronikou, Savvas [University of Cape Town, Department of Radiology, Cape Town (South Africa); Wieselthaler, Nicky; Smith, Bruce; Douis, Hassan [Red Cross Children' s Hospital, Department of Paediatric Radiology, School of Child and Adolescent Health, Cape Town (South Africa); Fieggen, A. Graham; Toorn, Ronald van; Wilmshurst, Jo [Red Cross Children' s Hospital, Department of Paediatric Radiology, School of Child and Adolescent Health, Cape Town (South Africa); Red Cross Children' s Hospital, Department of Neurosciences, School of Child and Adolescent Health, Cape Town (South Africa)

    2005-11-01

    The value of CT in the diagnosis of tuberculous meningitis (TBM) in children is well reported. Follow-up CT scanning for these patients is, however, not well described and, in particular, the value of early follow-up CT has not been addressed for children with TBM. To assess the value of early follow-up CT in children with TBM in identifying diagnostic, prognostic and therapeutically relevant features of TBM. A retrospective 4-year review of CT scans performed within 1 week and 1 month of initial CT in children with proven (CSF culture-positive) and probable TBM (CSF profile-positive but culture-negative) and comparison with initial CT for the diagnostic, prognostic and therapeutic CT features of TBM. The CT scans of 50 children were included (19 ''definite'' TBM; 31 ''probable'' TBM). Of these, 30 had CT scans performed within 1 week of the initial CT. On initial CT, 44 patients had basal enhancement. Only 24 patients had contrast medium-enhanced follow-up scans. Important findings include: 8 of 29 patients (who were not shunted) developed new hydrocephalus. New infarcts developed in 24 patients; 45% of those who did not have infarction initially developed new infarcts. Three of the six patients who did not show basal enhancement on initial scans developed this on the follow-up scans, while in seven patients with pre-existing basal enhancement this became more pronounced. Two patients developed hyperdensity in the cisterns on non-contrast medium scans. Eight patients developed a diagnostic triad of features. Three patients developed CT features of TBM where there was none on the initial scans. Early follow-up CT is useful in making a diagnosis of TBM by demonstrating features that were not present initially and by demonstrating more sensitive, obvious or additional features of TBM. In addition, follow-up CT is valuable as a prognostic indicator as it demonstrates additional infarcts which may have developed or become more

  20. Caffeine use and dependence in adolescents: one-year follow-up.

    Science.gov (United States)

    Oberstar, Joel V; Bernstein, Gail A; Thuras, Paul D

    2002-01-01

    The objectives were to conduct a 1-year follow-up of daily caffeine-using adolescents to further describe caffeine dependence symptoms and to determine whether caffeine dependence is associated with other substance dependence disorders. Twenty-one of 36 (58.3%) adolescents who participated in a study of caffeine dependence returned for follow-up. The previous study was a case series of adolescents who consumed caffeine daily and met some Diagnostic and Statistical Manual of Mental Disorders (fourth edition) substance dependence criteria as applied to caffeine. At follow-up, caffeine consumption from beverages was 179.9 +/- 151.8 mg/day. Of the 21 teenagers, 23.8% (n = 5) met criteria for caffeine dependence. Four of these participants developed caffeine dependence during the follow-up period. Other substance dependence disorders were not overrepresented in the caffeine dependent group compared to the caffeine nondependent group. The most commonly reported withdrawal symptoms in dependent teenagers (at baseline and follow-up combined) were feeling drowsy/tired, fatigued, or sluggish/slowed down (83.3% each) and headache (75.0%). Caffeine dependence occurs in some adolescents who drink caffeine daily and is marked by symptoms similar to those found in adults.

  1. Assessing factors for loss to follow-up of HIV infected patients in Guinea-Bissau

    DEFF Research Database (Denmark)

    Nordentoft, Pernille Bejer; Engell-Sørensen, Thomas; Jespersen, Sanne

    2017-01-01

    reasons were moving (29.1 %), travelling (17.5 %), and transferring to other clinics (11.7 %). Conclusion: A large proportion of the patients at the clinic were lost to follow-up. The main reason for this was found to be the geographic mobility of the population in Guinea-Bissau.......Purpose: The objective of this study was to ascertain vital status of patients considered lost to follow-up at an HIV clinic in Guinea-Bissau, and describe reasons for loss to follow-up (LTFU). Methods: This study was a cross-sectional sample of a prospective cohort, carried out between May 15...... and 12.6 % HIV-1/2) living within the DSS, 292 patients had been lost to follow-up and were, therefore, eligible for active follow-up. Vital status was ascertained in 65.9 % of eligible patients and 42.7 % were alive, while 23.2 % had died. Information on reasons for LTFU existed for 103 patients. Major...

  2. Improving Neurodevelopmental Surveillance and Follow-up in Infants with Congenital Heart Disease.

    Science.gov (United States)

    Michael, Mark; Scharf, Rebecca; Letzkus, Lisa; Vergales, Jeffrey

    2016-01-01

    We hypothesize that neurodevelopmental surveillance of targeted patients with congenital heart disease during the admission for their cardiac surgery would improve neurodevelopmental assessment and outpatient follow-up rates. All patients under 12 months of age who were operated on between October 2013 and October 2014 and were considered at risk for neurodevelopmental delay in accordance with the 2012 American Heart Association Scientific Statement were included. A protocol was implemented to increase surveillance of targeted patients during the hospitalization for their cardiac surgery. A historical control cohort was used from a 6-month period that preceded initiation of the program from July 2012 to December 2012. Univariate analysis assessed the effects of patient demographics, anatomy, postoperative course, and distance from clinic on inpatient screening and follow-up to evaluate areas for future improvement. Neurodevelopmental surveillance in the post-protocol period increased from 21% to 82% (P neurodevelopmental surveillance of high risk patients. Individuals that were younger and in the hospital longer were more likely to be successfully seen and comply with outpatient follow-up than those not receiving inpatient risk assessment. Patients with single ventricle anatomy may benefit from a modified follow-up schedule to improve compliance rates. Travel distance has no effect on likelihood of outpatient cardiac neurodevelopmental follow-up. © 2016 Wiley Periodicals, Inc.

  3. Pediatric superficial scald burns--reassessment of our follow-up protocol.

    Science.gov (United States)

    Egro, Francesco M; O'Neill, Jennifer K; Briard, Robert; Cubison, Tania C S; Kay, Alan R; Estela, Catalina M; Burge, Timothy S

    2010-01-01

    The most common pediatric burn injury is a superficial scald. The current follow-up protocol for such burns includes review of the patient at 2 weeks postinjury and then 2 months later. The authors decided to review the protocol to assess the need for this second follow-up. A retrospective study reviewed the case notes of patients younger than 16 years at the time of their injury presenting with a scald over 5% TBSA. The progress of healing and scar development up to 5 years follow-up was assessed. This study showed that scalds healing within 2 weeks following injury rarely became hypertrophic. A prospective study was performed over a 10-month period. All children who suffered a superficial partial-thickness scald injury were included. At the 2-week appointment, the need for further follow-up was predicted. The accuracy of this prediction was assessed 2 months later. This study showed that an experienced member of the burns team could reliably predict at 2-week appointment those children who could be safely discharged with no subsequent need for scar management. This study suggests that it will be safe to modify the follow-up protocol, reducing the number of clinic attendances.

  4. Parental Involvement in Cognitive Behavior Therapy for Children with Anxiety Disorders: 3-Year Follow-Up.

    Science.gov (United States)

    Walczak, Monika; Esbjørn, Barbara H; Breinholst, Sonja; Reinholdt-Dunne, Marie Louise

    2017-06-01

    Parental factors have been linked to childhood anxiety, hence, parental involvement in cognitive behavioral therapy (CBT) for anxious children has been examined. However, findings do not consistently show added effects of parent-enhanced CBT, longitudinal investigations are scarce and long-term effects unclear. In the present study, 40 out of 54 families who, 3 years previously, completed one of two types of CBT treatment: with limited or active parental involvement, were assessed using semi-structured diagnostic interviews. Diagnostic status at 3-years follow-up was compared between groups. Changes in diagnostic status across assessment points: posttreatment, 6-month and 3-year follow-up were analyzed within groups. Diagnostic change from 6-month to 3-year follow-up was compared between groups. Intent-to-treat analyses revealed no significant difference in diagnostic status between groups at 3-year follow-up. Nonetheless, children whose parents actively participated in treatment showed significantly more remission from 6-month to 3-year follow-up than children with limited parental participation.

  5. [Gender dysphoria in children and adolescents - treatment guidelines and follow-up study].

    Science.gov (United States)

    Meyenburg, Bernd; Kröger, Anne; Neugebauer, Rebecca

    2015-01-01

    Treatment guidelines for transidentity in children and adolescents are presently under discussion. We present an overview of the various treatment modalities. Further, follow-up data on children and adolescents referred for gender-identity problems are presented. Of the 84 patients seen for the first time more than 3 years before follow-up, 37 mailed in the completed questionnaires. In addition, 33 patients agreed to answer some short follow-up questions. We assessed steps of treatment, gender role, psychopathology, and psychotherapy. We compared differences in psychopathology in patients with vs. without gender role change and in patients with intense vs. less intense psychotherapy. A total of 22 patients had completely changed gender role, and some had started hormonal treatment und sex reassignment surgery. Most patients were satisfied with the treatment results. All patients showed less psychopathology on follow-up, independent of role change or intensity of psychotherapy. In general, the patients reported little psychopathology. Our follow-up results support the present treatment approach. In patients with little psychopathology, low-frequency supportive treatment appears sufficient to obtain safe judgement on hormonal of surgical treatment.

  6. Long-term follow-up of functional hypothalamic amenorrhea and prognostic factors.

    Science.gov (United States)

    Falsetti, Leopoldo; Gambera, Alessandro; Barbetti, Lorena; Specchia, Cristina

    2002-02-01

    This study evaluated the prognosis of functional hypothalamic amenorrhea (FHA) and the predictive factors of recovery, through a long-term follow-up. Ninety-three women affected by FHA underwent a follow-up for an average period of 8.1 yr (range 7-9 yr). At the end of the follow-up, 65 (70.7%) patients recovered. Statistical analysis showed that there was no association between recovery and anamnestic causes of FHA or with the echographic ovarian morphology but identified the predictive factors of recovery as the basal body mass index (BMI), the basal cortisol, and androstenedione plasma levels. A higher basal BMI and A, and lower cortisol values are positive prognostic factors for the recovery. Also the BMI, acquired during the follow-up, is important for FHA resolution: in fact, in recovered women the BMI increased or remained stable, whereas in nonrecovered women it decreased or remained stable. At the end of the follow-up, 52 (74.3%) patients treated with hormone replacement therapy and 8 (80%) with no therapy recovered, but only 5 (41.7%) with oral contraceptive pills recovered.

  7. Congenital arterioportal fistulas: radiological treatment and color Doppler US follow-up

    Energy Technology Data Exchange (ETDEWEB)

    Teplisky, Dario; Tincani, Eliana Uruena; Lipsich, Jose; Sierre, Sergio [Department of Interventional Radiology, Pichincha 1890, Buenos Aires (Argentina)

    2012-11-15

    Congenital intrahepatic arterioportal fistulas (APFs) are a rare cause of portal hypertension in children. Doppler US is a useful diagnostic imaging modality. Transarterial embolization is a minimally invasive and effective therapy allowing occlusion of the fistula and restoration of liver hemodynamics. To describe the clinical and radiologic findings, percutaneous treatment and role of D-US in the postembolization follow-up of children with APF. Between 2002 and 2011, four children with APF were treated. Initial diagnosis and follow-up was performed with D-US and confirmed by arteriography, followed by endovascular embolization in all patients. D-US demonstrated abnormal arterioportal communications in all patients. Six endovascular procedures were performed in these four children. In two children, no residual fistula was seen on D-US after the first procedure and symptoms resolved. In the other two children, D-US demonstrated residual flow through the fistula, with resolution of pathological D-US findings and symptoms after the second endovascular procedure. All four children were successfully treated and asymptomatic at the end of follow-up. The mean follow-up was 24 months. Interventional radiology has a key role in the treatment of congenital APF. D-US is a noninvasive and effective tool for the diagnosis and follow-up of these patients. (orig.)

  8. Medication overuse headache: a critical review of end points in recent follow-up studies

    DEFF Research Database (Denmark)

    Hagen, Knut; Jensen, Rigmor; Bøe, Magne Geir

    2010-01-01

    in headache index at the end of follow-up were reported in only one and two of nine studies, respectively. The present review demonstrated a lack of uniform end points used in recently published follow-up studies. Guidelines for presenting follow-up data on MOH are needed and we propose end points......No guidelines for performing and presenting the results of studies on patients with medication overuse headache (MOH) exist. The aim of this study was to review long-term outcome measures in follow-up studies published in 2006 or later. We included MOH studies with >6 months duration presenting...... a minimum of one predefined end point. In total, nine studies were identified. The 1,589 MOH patients (22% men) had an overall mean frequency of 25.3 headache days/month at baseline. Headache days/month at the end of follow-up was reported in six studies (mean 13.8 days/month). The decrease was more...

  9. Long-term follow-up of patients with Bartter syndrome type I and II.

    Science.gov (United States)

    Puricelli, Elena; Bettinelli, Alberto; Borsa, Nicolò; Sironi, Francesca; Mattiello, Camilla; Tammaro, Fabiana; Tedeschi, Silvana; Bianchetti, Mario G

    2010-09-01

    Little information is available on a long-term follow-up in Bartter syndrome type I and II. Clinical presentation, treatment and long-term follow-up (5.0-21, median 11 years) were evaluated in 15 Italian patients with homozygous (n = 7) or compound heterozygous (n = 8) mutations in the SLC12A1 (n = 10) or KCNJ1 (n = 5) genes. Thirteen new mutations were identified. The 15 children were born pre-term with a normal for gestational age body weight. Medical treatment at the last follow-up control included supplementation with potassium in 13, non-steroidal anti-inflammatory agents in 12 and gastroprotective drugs in five patients. At last follow-up, body weight and height were within normal ranges in the patients. Glomerular filtration rate was Bartter syndrome had a lower renin ratio (P Bartter syndrome. Patients with Bartter syndrome type I and II tend to present a satisfactory prognosis after a median follow-up of more than 10 years. Gallstones might represent a new complication of antenatal Bartter syndrome.

  10. International clinical guideline for the management of classical galactosemia: diagnosis, treatment, and follow-up.

    Science.gov (United States)

    Welling, Lindsey; Bernstein, Laurie E; Berry, Gerard T; Burlina, Alberto B; Eyskens, François; Gautschi, Matthias; Grünewald, Stephanie; Gubbels, Cynthia S; Knerr, Ina; Labrune, Philippe; van der Lee, Johanna H; MacDonald, Anita; Murphy, Elaine; Portnoi, Pat A; Õunap, Katrin; Potter, Nancy L; Rubio-Gozalbo, M Estela; Spencer, Jessica B; Timmers, Inge; Treacy, Eileen P; Van Calcar, Sandra C; Waisbren, Susan E; Bosch, Annet M

    2017-03-01

    Classical galactosemia (CG) is an inborn error of galactose metabolism. Evidence-based guidelines for the treatment and follow-up of CG are currently lacking, and treatment and follow-up have been demonstrated to vary worldwide. To provide patients around the world the same state-of-the-art in care, members of The Galactosemia Network (GalNet) developed an evidence-based and internationally applicable guideline for the diagnosis, treatment, and follow-up of CG. The guideline was developed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. A systematic review of the literature was performed, after key questions were formulated during an initial GalNet meeting. The first author and one of the working group experts conducted data-extraction. All experts were involved in data-extraction. Quality of the body of evidence was evaluated and recommendations were formulated. Whenever possible recommendations were evidence-based, if not they were based on expert opinion. Consensus was reached by multiple conference calls, consensus rounds via e-mail and a final consensus meeting. Recommendations addressing diagnosis, dietary treatment, biochemical monitoring, and follow-up of clinical complications were formulated. For all recommendations but one, full consensus was reached. A 93 % consensus was reached on the recommendation addressing age at start of bone density screening. During the development of this guideline, gaps of knowledge were identified in most fields of interest, foremost in the fields of treatment and follow-up.

  11. The impact of ocular tuberculosis on vision after two months of intensive therapy.

    Science.gov (United States)

    Oliveira, Suzana Batista Vereza de; Passos, Ângelo Ferreira; Hadad, David Jamil; Zbyszynski, Lorena; Júnior, Pedro Sousa de Almeida; Castellani, Luiz Guilherme Schmidt; Dietze, Reynaldo; Palaci, Moisés

    2018-04-18

    Tuberculosis (TB) is an infectious disease of global importance with major economic and social burden accounting for 25% of all avoidable deaths in developing countries. Extrapulmonary involvement may occur either in association with clinically apparent pulmonary tuberculosis or in isolation. This cross-sectional descriptive study aimed to evaluate the impact of ocular tuberculosis in visual acuity at baseline and after two months of intensive anti-tuberculous therapy. A sample of 133 pulmonary TB patients, seven disseminated TB, and three pleural TB patients was evaluated. All patients underwent routine ophthalmic evaluation, including assessment of visual acuity, biomicroscopy, applanation tonometry, indirect ophthalmoscopy, and fluorescent angiography as appropriate. None of the patients had impaired visual acuity due to TB. A rate of 4.2% (6/143) of ocular involvement was found. None of the patients with ocular involvement were HIV-infected. Of the six patients with ocular involvement, five met the diagnostic criteria for probable and one for possible ocular lesions. As for the type of ocular lesions, two patients had bilateral findings: one had sclerouveitis and the second had choroidal nodules. The other four patients presented with unilateral lesions: peripheral retinal artery occlusion in the right eye (one case), choroidal nodules in the left eye (one case), and choroidal nodules in the right eye (two cases). Patients progressed favorably after two month of intensive therapy, with no significant reduction in vision. Copyright © 2018 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.

  12. Open-label comparative clinical study of chlorproguanil-dapsone fixed dose combination (Lapdap alone or with three different doses of artesunate for uncomplicated Plasmodium falciparum malaria.

    Directory of Open Access Journals (Sweden)

    Daniel G Wootton

    2008-03-01

    Full Text Available The objective of this study was to determine the appropriate dose of artesunate for use in a fixed dose combination therapy with chlorproguanil-dapsone (CPG-DDS for the treatment of uncomplicated falciparum malaria.Open-label clinical trial comparing CPG-DDS alone or with artesunate 4, 2, or 1 mg/kg at medical centers in Blantyre, Malawi and Farafenni, The Gambia. The trial was conducted between June 2002 and February 2005, including 116 adults (median age 27 years and 107 children (median age 38 months with acute uncomplicated Plasmodium falciparum malaria. Subjects were randomized into 4 groups to receive CPG-DDS alone or plus 4, 2 or 1 mg/kg of artesunate once daily for 3 days. Assessments took place on Days 0-3 in hospital and follow-up on Days 7 and 14 as out-patients. Efficacy was evaluated in the Day 3 per-protocol (PP population using mean time to reduce baseline parasitemia by 90% (PC90. A number of secondary outcomes were also included. Appropriate artesunate dose was determined using a pre-defined decision matrix based on primary and secondary outcomes. Treatment emergent adverse events were recorded from clinical assessments and blood parameters. Safety was evaluated in the intent to treat (ITT population.In the Day 3 PP population for the adult group (N = 85, mean time to PC90 was 19.1 h in the CPG-DDS group, significantly longer than for the +artesunate 1 mg/kg (12.5 h; treatment difference -6.6 h [95%CI -11.8, -1.5], 2 mg/kg (10.7 h; -8.4 h [95%CI -13.6, -3.2] and 4 mg/kg (10.3 h; -8.7 h [95%CI -14.1, -3.2] groups. For children in the Day 3 PP population (N = 92, mean time to PC90 was 21.1 h in the CPG-DDS group, similar to the +artesunate 1 mg/kg group (17.7 h; -3.3 h [95%CI -8.6, 2.0], though the +artesunate 2 mg/kg and 4 mg/kg groups had significantly shorter mean times to PC90 versus CPG-DDS; 14.4 h (treatment difference -6.4 h [95%CI -11.7, -1.0] and 12.8 h (-7.4 h [95%CI -12.9, -1.8], respectively. An analysis of mean time

  13. Peg-interferon plus nucleotide analogue treatment versus no treatment in patients with chronic hepatitis B with a low viral load: a randomised controlled, open-label trial.

    Science.gov (United States)

    de Niet, Annikki; Jansen, Louis; Stelma, Femke; Willemse, Sophie B; Kuiken, Sjoerd D; Weijer, Sebastiaan; van Nieuwkerk, Carin M J; Zaaijer, Hans L; Molenkamp, Richard; Takkenberg, R Bart; Koot, Maarten; Verheij, Joanne; Beuers, Ulrich; Reesink, Hendrik W

    2017-08-01

    Antiviral treatment is currently not recommended for patients with chronic hepatitis B with a low viral load. However, they might benefit from acquiring a functional cure (hepatitis B surface antigen [HBsAg] loss with or without formation of antibodies against hepatitis B surface antigen [anti-HBs]). We assessed HBsAg loss during peg-interferon-alfa-2a (peg-IFN) and nucleotide analogue combination therapy in patients with chronic hepatitis B with a low viral load. In this randomised controlled, open-label trial, patients were enrolled from the Academic Medical Center (AMC), Amsterdam, Netherlands. Eligible patients were HBsAg positive and hepatitis B e antigen (HBeAg) negative for more than 6 months, could be treatment naive or treatment experienced, and had alanine aminotransferase (ALT) concentrations less than 5 × upper limit of normal (ULN). Participants were randomly assigned (1:1:1) by a computerised randomisation programme (ALEA Randomisation Service) to receive peg-IFN 180 μg/week plus adefovir 10 mg/day, peg-IFN 180 μg/week plus tenofovir disoproxil fumarate 245 mg/day, or no treatment for 48 weeks. The primary endpoint was the proportion of patients with serum HBsAg loss among those who received at least one dose of study drug or had at least one study visit (modified intention-to-treat population [mITT]). All patients have finished the initial study of 72 weeks and will be observed for up to 5 years of follow-up. This study is registered with ClinicalTrials.gov, number NCT00973219. Between Aug 4, 2009, and Oct 17, 2013, 167 patients were screened for enrolment, of whom 151 were randomly assigned (52 to peg-IFN plus adefovir, 51 to peg-IFN plus tenofovir, and 48 to no treatment). 46 participants in the peg-IFN plus adefovir group, 45 in the peg-IFN plus tenofovir group, and 43 in the no treatment group began treatment or observation and were included in the mITT population. At week 72, two (4%) patients in the peg-IFN plus adefovir group and two (4

  14. Open-label phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L

    Directory of Open Access Journals (Sweden)

    Tarakanovskaya MG

    2017-04-01

    Full Text Available Marina G Tarakanovskaya,1 Jigjidsuren Chinburen,2 Purev Batchuluun,2 Chogsom Munkhzaya,2 Genden Purevsuren,2 Dorjiin Dandii,3 Tsogkhuu Hulan,3 Dandii Oyungerel,4 Galyna A Kutsyna,5 Alan A Reid,6 Vika Borisova,6 Allen I Bain,7 Vichai Jirathitikal,7 Aldar S Bourinbaiar6–8 1Ekomed LLC, 2National Cancer Center, 3Monserum LLC, 4National Center for Public Health, Ulaanbaatar, Mongolia; 5Department of Infectious Diseases, Luhansk State Medical University, Luhansk, Ukraine; 6Immunitor China Ltd, Beijing, People’s Republic of China; 7Immunitor Inc, Vancouver, BC, Canada; 8Immunitor LLC, Ulaanbaatar, Mongolia Background: An increasing number of studies is now devoted to immunotherapy of cancer. We evaluated the clinical benefit of hepcortespenlisimut-L (Hepko-V5 [formerly known as V5]—an oral therapeutic vaccine designated by the United States Food and Drug Administration (FDA as an orphan drug for treatment of hepatocellular carcinoma (HCC. V5 was initially developed by us in 2002 to treat hepatitis B or C viral infections and liver cirrhosis.Methods: The outcome of open-label Phase II trial of daily dose of V5 pill was analyzed retrospectively. Over a period of 5 years, 75 patients with advanced HCC were enrolled, consisting of 29 (38.7% females and 46 (61.3% males with a median age of 60 years (mean 61.6±8.1 years. Out of these, 23 (30.7% had hepatitis B and 34 (45.3% had hepatitis C infections, including 9 (12% with dual infection, 4 (5.3% negative for both viruses, and 5 (6.7% without established viral diagnosis. Most patients (94.7% had underlying liver cirrhosis of varying severity.Results: After a median of 2 months of treatment, 50 out of 75 patients had experienced a decline in serum levels of the tumor marker, alpha-fetoprotein (AFP (66.7%; P=0.006 by Wilcoxon signed rank test. Baseline median AFP levels were 245.2 IU/mL (mean 4,233; range 7.2–92,407; 95% confidence interval [CI] 1,186–7,280 and post-treatment values were 102.3 IU

  15. Ibrutinib in combination with rituximab in relapsed or refractory mantle cell lymphoma: a single-centre, open-label, phase 2 trial.

    Science.gov (United States)

    Wang, Michael L; Lee, Hun; Chuang, Hubert; Wagner-Bartak, Nicolaus; Hagemeister, Frederick; Westin, Jason; Fayad, Luis; Samaniego, Felipe; Turturro, Francesco; Oki, Yasuhiro; Chen, Wendy; Badillo, Maria; Nomie, Krystle; DeLa Rosa, Maria; Zhao, Donglu; Lam, Laura; Addison, Alicia; Zhang, Hui; Young, Ken H; Li, Shaoying; Santos, David; Medeiros, L Jeffrey; Champlin, Richard; Romaguera, Jorge; Zhang, Leo

    2016-01-01

    Ibrutinib is approved in the EU, USA, and other countries for patients with mantle cell lymphoma who received one previous therapy. In a previous phase 2 study with single-agent ibrutinib, the proportion of patients who achieved an objective response was 68%; 38 (34%) of 111 patients had transient lymphocytosis. We hypothesised that adding rituximab could target mantle cell lymphoma cells associated with redistribution lymphocytosis, leading to more potent antitumour activity. Patients with a confirmed mantle cell lymphoma diagnosis (based on CD20-positive and cyclin D1-positive cells in tissue biopsy specimens), no upper limit on the number of previous treatments received, and an Eastern Cooperative Oncology Group performance status score of 2 or less were enrolled in this single-centre, open-label, phase 2 study. Patients received continuous oral ibrutinib (560 mg) daily until progressive disease or unacceptable toxic effects. Rituximab 375 mg/m(2) was given intravenously once per week for 4 weeks during cycle 1, then on day 1 of cycles 3-8, and thereafter once every other cycle up to 2 years. The primary endpoint was the proportion of patients who achieved an objective response in the intention-to-treat population and safety assessed in the as-treated population. The study is registered with ClinicalTrials.gov, number NCT01880567, and is still ongoing, but no longer accruing patients. Between July 15, 2013, and June 30, 2014, 50 patients were enrolled. Median age was 67 years (range 45-86), and the median number of previous regimens was three (range 1-9). At a median follow-up of 16·5 months (IQR 12·09-19·28), 44 (88%, 95% CI 75·7-95·5) patients achieved an objective response, with 22 (44%, 30·0-58·7) patients achieving a complete response, and 22 (44%, 30·0-58·7) a partial response. The only grade 3 adverse event in >=10% of patients was atrial fibrillation, which was noted in six (12%) patients. Grade 4 diarrhoea and neutropenia occurred in one

  16. Pembrolizumab in advanced soft-tissue sarcoma and bone sarcoma (SARC028): a multicentre, two-cohort, single-arm, open-label, phase 2 trial.

    Science.gov (United States)

    Tawbi, Hussein A; Burgess, Melissa; Bolejack, Vanessa; Van Tine, Brian A; Schuetze, Scott M; Hu, James; D'Angelo, Sandra; Attia, Steven; Riedel, Richard F; Priebat, Dennis A; Movva, Sujana; Davis, Lara E; Okuno, Scott H; Reed, Damon R; Crowley, John; Butterfield, Lisa H; Salazar, Ruth; Rodriguez-Canales, Jaime; Lazar, Alexander J; Wistuba, Ignacio I; Baker, Laurence H; Maki, Robert G; Reinke, Denise; Patel, Shreyaskumar

    2017-11-01

    Patients with advanced sarcomas have a poor prognosis and few treatment options that improve overall survival. Chemotherapy and targeted therapies offer short-lived disease control. We assessed pembrolizumab, an anti-PD-1 antibody, for safety and activity in patients with advanced soft-tissue sarcoma or bone sarcoma. In this two-cohort, single-arm, open-label, phase 2 study, we enrolled patients with soft-tissue sarcoma or bone sarcoma from 12 academic centres in the USA that were members of the Sarcoma Alliance for Research through Collaboration (SARC). Patients with soft-tissue sarcoma had to be aged 18 years or older to enrol; patients with bone sarcoma could enrol if they were aged 12 years or older. Patients had histological evidence of metastatic or surgically unresectable locally advanced sarcoma, had received up to three previous lines of systemic anticancer therapy, had at least one measurable lesion according to the Response Evaluation Criteria In Solid Tumors version 1.1, and had at least one lesion accessible for biopsy. All patients were treated with 200 mg intravenous pembrolizumab every 3 weeks. The primary endpoint was investigator-assessed objective response. Patients who received at least one dose of pembrolizumab were included in the safety analysis and patients who progressed or reached at least one scan assessment were included in the activity analysis. Accrual is ongoing in some disease cohorts. This trial is registered with ClinicalTrials.gov, number NCT02301039. Between March 13, 2015, and Feb 18, 2016, we enrolled 86 patients, 84 of whom received pembrolizumab (42 in each disease cohort) and 80 of whom were evaluable for response (40 in each disease cohort). Median follow-up was 17·8 months (IQR 12·3-19·3). Seven (18%) of 40 patients with soft-tissue sarcoma had an objective response, including four (40%) of ten patients with undifferentiated pleomorphic sarcoma, two (20%) of ten patients with liposarcoma, and one (10%) of ten patients

  17. A randomized, open-label study to investigate the effect of belimumab on pneumococcal vaccination in patients with active, autoantibody-positive systemic lupus erythematosus.

    Science.gov (United States)

    Chatham, W; Chadha, A; Fettiplace, J; Kleoudis, C; Bass, D; Roth, D; Gordon, D

    2017-12-01

    Objective Intravenous belimumab 10 mg/kg is approved as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus. This study aimed to assess the impact of belimumab on immune response to pneumococcal vaccination in patients with systemic lupus erythematosus. Methods This was a Phase 4, open-label study (GSK BEL115470; NCT01597492) conducted in the United States. Patients were randomized (7:9) to receive a 23-valent pneumococcal vaccination four weeks prior to (pre-belimumab cohort) or 24 weeks after (belimumab-concurrent cohort) commencing four-weekly belimumab 10 mg/kg intravenous treatment plus standard systemic lupus erythematosus therapy. Analyses of vaccine titers were performed on the as-treated population (received ≥1 dose of belimumab). The primary endpoint was the proportion of patients with positive antibody responses (≥2-fold increase from pre-vaccination levels, or post-vaccination level ≥ 0.6 µg/mL if pre-vaccination levels were unquantifiable) to ≥1 of 23 pneumococcal vaccine serotypes, four weeks post vaccination. Other endpoints included the proportion of patients with positive antibody responses to ≥2 to ≥10, and ≥11-23 (post hoc analysis) of serotypes. Safety was assessed by monitoring adverse events. Results Seventy-nine patients received pneumococcal vaccination (pre-belimumab cohort, n = 34; belimumab-concurrent cohort, n = 45). The majority (87.3% [69/79]) completed the study; 10 (12.7%) withdrew (patient request, n = 3; adverse event, n = 3; lost to follow-up, n = 2; other, n = 2). At Week 4 post-vaccination, 97.0% (32/33) and 97.6% (40/41) of patients (pre-belimumab and concurrent belimumab cohorts, respectively) had a positive response to ≥1 of 23 pneumococcal serotypes. Over 85% of patients in both cohorts responded to ≥10 of serotypes, approximately 80% responded to ≥12 serotypes, and approximately two-thirds responded to ≥16 serotypes. Little

  18. Safety and efficacy of diaphragm pacing in patients with respiratory insufficiency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial.

    Science.gov (United States)

    2015-09-01

    Non-invasive ventilation is part of the standard of care for treatment of respiratory failure in patients with amyotrophic lateral sclerosis (ALS). The NeuRx RA/4 Diaphragm Pacing System has received Humanitarian Device Exemption approval from the US Food and Drug Administration for treatment of respiratory failure in patients with ALS. We aimed to establish the safety and efficacy of diaphragm pacing with this system in patients with respiratory muscle weakness due to ALS. We undertook a multicentre, open-label, randomised controlled trial at seven specialist ALS and respiratory centres in the UK. Eligible participants were aged 18 years or older with laboratory supported probable, clinically probable, or clinically definite ALS; stable riluzole treatment for at least 30 days; and respiratory insufficiency. We randomly assigned participants (1:1), via a centralised web-based randomisation system with minimisation that balanced patients for age, sex, forced vital capacity, and bulbar function, to receive either non-invasive ventilation plus pacing with the NeuRx RA/4 Diaphragm Pacing System or non-invasive ventilation alone. Patients, carers, and outcome assessors were not masked to treatment allocation. The primary outcome was overall survival, defined as the time from randomisation to death from any cause. Analysis was by intention to treat. This trial is registered, ISRCTN number 53817913. Between Dec 5, 2011, and Dec 18, 2013, we randomly assigned 74 participants to receive either non-invasive ventilation alone (n=37) or non-invasive ventilation plus diaphragm pacing (n=37). On Dec 18, 2013, the Data Monitoring and Ethics Committee (DMEC) recommended suspension of recruitment on the basis of overall survival figures. Randomly assigned participants continued as per the study protocol until June 23, 2014, when the DMEC advised discontinuation of pacing in all patients. Follow-up assessments continued until the planned end of the study in December, 2014. Survival

  19. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial.

    Science.gov (United States)

    Kaufman, Howard L; Russell, Jeffery; Hamid, Omid; Bhatia, Shailender; Terheyden, Patrick; D'Angelo, Sandra P; Shih, Kent C; Lebbé, Céleste; Linette, Gerald P; Milella, Michele; Brownell, Isaac; Lewis, Karl D; Lorch, Jochen H; Chin, Kevin; Mahnke, Lisa; von Heydebreck, Anja; Cuillerot, Jean-Marie; Nghiem, Paul

    2016-10-01

    Merkel cell carcinoma is a rare, aggressive skin cancer with poor prognosis in patients with advanced disease. Current standard care uses various cytotoxic chemotherapy regimens, but responses are seldom durable. Tumour oncogenesis is linked to Merkel cell polyomavirus integration and ultraviolet-radiation-induced mutations, providing rationale for treatment with immunotherapy antibodies that target the PD-L1/PD-1 pathway. We assessed treatment with avelumab, an anti-PD-L1 monoclonal antibody, in patients with stage IV Merkel cell carcinoma that had progressed after cytotoxic chemotherapy. In this multicentre, international, prospective, single-group, open-label, phase 2 trial, patients with stage IV chemotherapy-refractory, histologically confirmed Merkel cell carcinoma (aged ≥18 years) were enrolled from 35 cancer treatment centres and academic hospitals in North America, Europe, Australia, and Asia. Key eligibility criteria were an ECOG performance status of 0 or 1, measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, adequate haematological, hepatic, and renal function, and immune-competent status (patients with HIV, immunosuppression, haematological malignancies, and previous organ transplantation were excluded). Patient selection was not based on PD-L1 expression or Merkel cell polyomavirus status. Collection of biopsy material or use of archival tissue for these assessments was mandatory. Avelumab was given intravenously at a dose of 10 mg/kg every 2 weeks. The primary endpoint was confirmed objective response (complete response or partial response) assessed according to RECIST version 1.1 by an independent review committee. Safety and clinical activity were assessed in all patients who received at least one dose of study drug (the modified intention-to-treat population). This trial is registered with ClinicalTrials.gov as NCT02155647. Between July 25, 2014, and Sept 3, 2015, 88 patients were enrolled and received at

  20. Intravitreous injection of AAV2-sFLT01 in patients with advanced neovascular age-related macular degeneration: a phase 1, open-label trial.

    Science.gov (United States)

    Heier, Jeffrey S; Kherani, Saleema; Desai, Shilpa; Dugel, Pravin; Kaushal, Shalesh; Cheng, Seng H; Delacono, Cheryl; Purvis, Annie; Richards, Susan; Le-Halpere, Annaig; Connelly, John; Wadsworth, Samuel C; Varona, Rafael; Buggage, Ronald; Scaria, Abraham; Campochiaro, Peter A

    2017-07-01

    Long-term intraocular injections of vascular endothelial growth factor (VEGF)-neutralising proteins can preserve central vision in many patients with neovascular age-related macular degeneration. We tested the safety and tolerability of a single intravitreous injection of an AAV2 vector expressing the VEGF-neutralising protein sFLT01 in patients with advanced neovascular age-related macular degeneration. This was a phase 1, open-label, dose-escalating study done at four outpatient retina clinics in the USA. Patients were assigned to each cohort in order of enrolment, with the first three patients being assigned to and completing the first cohort before filling positions in the following treatment groups. Patients aged 50 years or older with neovascular age-related macular degeneration and a baseline best-corrected visual acuity score of 20/100 or less in the study eye were enrolled in four dose-ranging cohorts (cohort 1, 2 × 10 8 vector genomes (vg); cohort 2, 2 × 10 9 vg; cohort 3, 6 × 10 9 vg; and cohort 4, 2 × 10 10 vg, n=3 per cohort) and one maximum tolerated dose cohort (cohort 5, 2 × 10 10 vg, n=7) and followed up for 52 weeks. The primary objective of the study was to assess the safety and tolerability of a single intravitreous injection of AAV2-sFLT01, through the measurement of eye-related adverse events. This trial is registered with ClinicalTrials.gov, number NCT01024998. 19 patients with advanced neovascular age-related macular degeneration were enrolled in the study between May 18, 2010, and July 14, 2014. All patients completed the 52-week trial period. Two patients in cohort 4 (2 × 10 10 vg) experienced adverse events that were possibly study-drug related: pyrexia and intraocular inflammation that resolved with a topical steroid. Five of ten patients who received 2 × 10 10 vg had aqueous humour concentrations of sFLT01 that peaked at 32·7-112·0 ng/mL (mean 73·7 ng/mL, SD 30·5) by week 26 with a slight decrease to

  1. Scanning usefulness for bone metastases diagnosis in the breast cancer follow-up

    International Nuclear Information System (INIS)

    Guillen, G.; Martinez, P.; Garcia, F.; Tres, A.

    1988-01-01

    It is studied the incidence of osseus metastases and the usefulness of 179 bone scanning realized in the diagnosis and follow-up (average: 23,6 months) of 87 patients operated by breast cancer. It is obvious the scan sensitivity and its unspecificity (15,08% phase-positives). In 13 (14,9%) patients who showed them, during the follow-up, scan was pathological at the moment of the osseus metastases diagnosis or a bit later; there were other clinical data or abnormal analytical ones of suspicion in 77% of them. The time average of appearance is 27 months after surgery. We concluded that the bone scan in the follow-up of breast cancer will be realized only when clinical or analytical suspicion of bone metastases. (Author)

  2. Weight Suppression Predicts Maintenance and Onset of Bulimic Syndromes at 10-Year Follow-up

    Science.gov (United States)

    Keel, Pamela K.; Heatherton, Todd F.

    2010-01-01

    Conflicting results have emerged regarding the prognostic significance of weight suppression for maintenance of bulimic symptoms. This study examined whether the magnitude of weight suppression would predict bulimic syndrome maintenance and onset in college-based samples of men (n=369) and women (n=968) at 10-year follow-up. Data come from a longitudinal study of body weight and disordered eating with high retention (80%). Among those with a bulimic syndrome at baseline, greater weight suppression significantly predicted maintenance of the syndrome, and, among those without a bulimic syndrome at baseline, greater weight suppression predicted onset of a bulimic syndrome at 10-year follow-up in multivariate models that included baseline body mass index, diet frequency, and weight perception. Future research should address mechanisms that could account for the effects of weight suppression over a long duration of follow-up. PMID:20455599

  3. Balloon catheter dilatation in esophageal achalasia: long term follow-up

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Cheol Yong; Park, Hyun Mee; Kim, So Eun; Lee, Shin Hyung; Kim, Seung Hyeon; Lee, Chang Joon [National Medical Center, Seoul (Korea, Republic of)

    1994-12-15

    To evaluate the clinical efficacy of balloon catheter dilatation in the treatment of esophageal achalasia. Seven patients(three males and four females) with esopha-geal achalasia were treated with balloon catheter dilatation. Balloon catheters of variable sizes were used depending on patient's conditions. The patients were followed up over a period of 12-39 months. Balloon catheter dilatation in esophageal achalasia was successful in all patients without esophageal perforation. All patients were relieved from dysphagia. Recurrence was not found in 5 patients on long term follow-up study, but was seen in 2 patients after 18 and 21 months, respectively. Balloon catheter dilatation was a safe and effective method in the treatment of esophageal achalasia with low recurrence rate of 29% on follow-up study.

  4. Balloon catheter dilatation in esophageal achalasia: long term follow-up

    International Nuclear Information System (INIS)

    Shin, Cheol Yong; Park, Hyun Mee; Kim, So Eun; Lee, Shin Hyung; Kim, Seung Hyeon; Lee, Chang Joon

    1994-01-01

    To evaluate the clinical efficacy of balloon catheter dilatation in the treatment of esophageal achalasia. Seven patients(three males and four females) with esopha-geal achalasia were treated with balloon catheter dilatation. Balloon catheters of variable sizes were used depending on patient's conditions. The patients were followed up over a period of 12-39 months. Balloon catheter dilatation in esophageal achalasia was successful in all patients without esophageal perforation. All patients were relieved from dysphagia. Recurrence was not found in 5 patients on long term follow-up study, but was seen in 2 patients after 18 and 21 months, respectively. Balloon catheter dilatation was a safe and effective method in the treatment of esophageal achalasia with low recurrence rate of 29% on follow-up study

  5. The Effect of Auditor Quality on the Follow-Up of Audit Recommendation

    Directory of Open Access Journals (Sweden)

    Dyah Setyaningrum

    2013-08-01

    Full Text Available The purpose of this study is to measure auditor quality of The Audit Board of the Republic of Indonesia (BPK and investigates the effect of auditor quality on the follow-up of audit recommendation. This study uses sample of local government financial statements in Indonesia from 2010-2012. Using principle component analysis method, the result shows that there are four components extracted that form auditor quality which is experience, training, motivation, and education. All four components are then combined into a single auditor quality index that represents comprehensive measure of auditor quality. The test result shows positive effect between auditor quality and follow-up of audit recommendation. This indicates that high quality auditor is able to produce appropriate recommendations that can be easily followed up by the auditee. The more recommendations are acted upon, the better the quality of local government financial statements.

  6. DESGW: Optical Follow-up of BBH LIGO-Virgo Events with DECam

    Energy Technology Data Exchange (ETDEWEB)

    Butler, Robert E. [Indiana U.; Soares-Santos, M. [Brandeis U.; Annis, j. [Fermilab; Herner, K. [Fermilab

    2017-12-14

    The DESGW program is a collaboration between members of the Dark Energy Survey, the wider astronomical community, and the LIGO-Virgo Collaboration to search for optical counterparts of gravitational wave events, such as those expected from binary neutron star mergers or neutron star-black hole mergers. While binary black hole (BBH) events are not expected to produce an electromagnetic (EM) signature, emission is certainly not impossible. The DESGW program has performed follow-up observations of four BBH events detected by LIGO in order to search for any possible EM counterpart. Failure to nd such counterparts is still relevant in that it produces limits on optical emission from such events. This is a review of follow-up results from O1 BBH events and a discussion of the status of ongoing uniform re-analysis of all BBH events that DESGW has followed up to date.

  7. Loss to follow up did not bias associations between early life factors and adult depression

    DEFF Research Database (Denmark)

    Osler, Merete; Kriegbaum, Margit; Christensen, Ulla

    2008-01-01

    a single mother at birth, low educational attainment at age 18, and low cognitive function at ages 12 and 18. Hospitalizations for depression and having claimed a prescription for an antidepressive drug were also most frequent among men who did not respond in the follow up. However, the effect......OBJECTIVE: This study examines the consequences of nonresponse in a follow-up survey for the associations of early life factors with adult depression. STUDY DESIGN AND SETTING: A cohort of 11,532 Danish men born in 1953 had nearly complete follow up for outcomes retrieved from the Danish...... characteristics and four measures of depression were described by odd ratios (OR), estimated by logistic regression. For the register-based measures the effect of nonresponse was described by a relative OR(OR(responders)/OR(entire cohort)=ROR). RESULTS: Nonresponse at 50 years of age was related to having...

  8. Prognosis on follow-up CT of chronic subdural hematomas treated by burr hole evacuation

    International Nuclear Information System (INIS)

    Higeta, Toshiaki; Yamada, Hiroshi; Itoh, Hakuji

    1986-01-01

    A consecutive series of 47 adult patients with chronic subdural hematoma was studied in respect to postoperative follow-up CT after burr hole evacuation. In 15 of our patients, the CT scan was normalized within 60 days. Six patients required reoperation because of reaccumulation or of poor re-expansion, and in 13 patients the follow-up CT showed a persisting subdural fluid collection even after 60 postoperative days. Further studying the correlation between the prognosis on follow-up CT and various factors, such as patient's age, preoperative neurological condition and CT findings or others, authors found that the elderly, especially older than 70 years, had a poor prognosis, and that the prognosis was correlated to the density and the thickness of hematoma on preoperative CT scan. (author)

  9. Follow-up services for stroke survivors after hospital discharge--a randomized control study

    DEFF Research Database (Denmark)

    Andersen, Hanne Elkjaer; Eriksen, Karen; Brown, Anne

    2002-01-01

    OBJECTIVE: To evaluate whether follow-up services for stroke survivors could improve functional outcome and reduce readmission rate. In this paper results of functional outcome are reported. DESIGN: Randomized controlled trial allocating patients to one of three different types of aftercare: (1......) follow-up home visits by a physician, (2) physiotherapist instruction in the patient's home, or (3) standard aftercare. SUBJECTS: Stroke patients with persisting impairment and disability who, after completing inpatient rehabilitation, were discharged to their homes. OUTCOME MEASURES: Six months after...... discharge, functional outcome was assessed with Functional Quality of Movement, Barthel Index, Frenchay Activity Index and Index of Extended Activites of Daily Living. RESULTS: One-hundred and fifty-five stroke patients were included in the study. Fifty-four received follow-up home visits by a physician, 53...

  10. A simplified approach for ratcheting analysis in structures with elastic follow-up

    International Nuclear Information System (INIS)

    Berton, M.N.; Cabrillat, M.T.

    1991-01-01

    In the framework of an elastic analysis, the RCC-MR design code uses the concept of the efficiency diagram to assess the behaviour of a structure relatively to ratcheting. This diagram was obtained from a lot of experimental results and allows to cover many reactor situations. However this approach needs to classify stresses between primary and secondary stresses and for a few cases, in particular for structures with significant elastic follow-up, this classification is not obvious. After a recall of elastic follow-up definition and a few considerations on the way to evaluate it, an approach is proposed to take it into account in an elastic analysis verifying the avoidance of ratcheting. An experimental program has been developed to study this interaction between elastic follow-up and ratcheting. The first results are presented together with interpretations with the proposed method. (author)

  11. Slow-growing labyrinthine masses: contribution of MRI to diagnosis, follow-up and treatment

    International Nuclear Information System (INIS)

    Deux, J.F.; Marsot-Dupuch, K.; Tubiana, J.M.; Tran Ba Huy, P.; Sterkers, J.M.

    1998-01-01

    We report the use of MRI in the diagnosis, follow-up and therapeutic management of three cases of intralabyrinthine Schwannoma. The diagnosis was based on the history and initial and follow-up MRI findings. The main feature suggesting the diagnosis was a nodular intralabyrinthine mass of low signal intensity on T2-weighted images, and high or isointense signal on T1-weighted images (relative to cerebrospinal fluid), which showed contrast enhancement. Follow-up imaging showed growth of the tumour in one patient. One patient underwent surgery for severe tinnitus. To detect these lesions, MRI should be focussed on the inner ear, using thin-section T2-weighted and T1-weighted images before and after contrast medium. MRI allowed informed surgical planning. (orig.) (orig.)

  12. Slow-growing labyrinthine masses: contribution of MRI to diagnosis, follow-up and treatment

    Energy Technology Data Exchange (ETDEWEB)

    Deux, J F; Marsot-Dupuch, K; Tubiana, J M [Hopital Saint-Antoine, Paris (France). Service de Radiology; Ouayoun, M; Meyer, B [Service d` ORL, Hopital Saint-Antoine, 184 rue du Faubourg Saint-Antoine, F-75012 Paris (France); Tran Ba Huy, P [Service d` ORL, Hopital Lariboisiere, 2 rue Ambroise Pare, F-75010 Paris (France); Sterkers, J M

    1998-10-01

    We report the use of MRI in the diagnosis, follow-up and therapeutic management of three cases of intralabyrinthine Schwannoma. The diagnosis was based on the history and initial and follow-up MRI findings. The main feature suggesting the diagnosis was a nodular intralabyrinthine mass of low signal intensity on T2-weighted images, and high or isointense signal on T1-weighted images (relative to cerebrospinal fluid), which showed contrast enhancement. Follow-up imaging showed growth of the tumour in one patient. One patient underwent surgery for severe tinnitus. To detect these lesions, MRI should be focussed on the inner ear, using thin-section T2-weighted and T1-weighted images before and after contrast medium. MRI allowed informed surgical planning. (orig.) (orig.) With 3 figs., 1 tab., 21 refs.

  13. What Happens Next? Follow-Up From the Children's Toddler School Program.

    Science.gov (United States)

    Akshoomoff, Natacha; Stahmer, Aubyn C; Corsello, Christina; Mahrer, Nicole E

    2010-10-01

    This study was a follow-up of a group of 29 children diagnosed with autism spectrum disorders at age 2 who attended an inclusive toddler program until age 3. Children ranged in age from 4 to 12 years at the time of the parent survey and follow-up testing. The majority of children were placed in a special education (noninclusive) preschool class, but among the children who were in elementary school at the time of follow-up, 63% were in general education classroom placement. Diagnoses of autism spectrum disorders remained stable, socialization skills remained a weakness, and child-related parental stress remained high despite average cognitive and language skills in the majority of children. Social skill development and support remained a service need.

  14. [Testicular cancer: a model to optimize the radiological follow-up].

    Science.gov (United States)

    Stebler, V; Pauchard, B; Schmidt, S; Valerio, M; De Bari, B; Berthold, D

    2015-05-20

    Despite being rare cancers, testicular seminoma and non-seminoma play an important role in oncology: they represent a model on how to optimize radiological follow-up, aiming at a lowest possible radiation exposure and secondary cancer risk. Males diagnosed with testicular cancer undergo frequently prolonged follow-up with CT-scans with potential toxic side effects, in particular secondary cancers. To reduce the risks linked to ionizing radiation, precise follow-up protocols have been developed. The number of recommended CT-scanners has been significantly reduced over the last 10 years. The CT scanners have evolved technically and new acquisition protocols have the potential to reduce the radiation exposure further.

  15. Follow-up of abnormal or inadequate test results in the Danish Cervical Cancer Screening Program

    DEFF Research Database (Denmark)

    Kristiansen, Bettina Kjær

    2014-01-01

    Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23–65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer. Annually 40 000 women receives an abnormal or inadequate test result and a follow......-up recommendation. However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress into cancer. Delayed follow-up is found in situations where women either consciously or unconsciously postpone...... up will be sent to the women (RCT). The intention is to ensure that all women will be notified about the test result, quickly, homogenously and in layman’s written language, still with the opportunity to contact or be contacted by the GP, if there is special needs. Furthermore, it is assumed that GP...

  16. Gynecologic follow up of 129 women on dialysis and after kidney transplantation: a retrospective cohort study.

    Science.gov (United States)

    Chakhtoura, Zeina; Meunier, Marie; Caby, Jacqueline; Mercadal, Lucile; Arzouk, Nadia; Barrou, Benoît; Touraine, Philippe

    2015-04-01

    To describe the gynecologic issues and follow-up in our referral center of women on dialysis and after kidney transplantation. This retrospective cohort study included 129 dialysed women among whom 102 had had transplants. Data on menstrual pattern, pregnancies, contraception, and cervical cytology were retrieved from patients' files. The follow-up started at age 41.6±14.2 years and lasted for 9.5±10.2 years. Of the women, 78.7% had regular menses before dialysis, decreasing to 30.6% on dialysis (pirregular menses and metrorrhagia which was improved by chlormadinone acetate. We noted high rates of obstetrical complications and abnormal smear tests. Consequently, this population must have close follow-up to identify and treat gynecologic issues. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  17. Results of remote follow-up and monitoring in young patients with cardiac implantable electronic devices.

    Science.gov (United States)

    Silvetti, Massimo S; Saputo, Fabio A; Palmieri, Rosalinda; Placidi, Silvia; Santucci, Lorenzo; Di Mambro, Corrado; Righi, Daniela; Drago, Fabrizio

    2016-01-01

    Remote monitoring is increasingly used in the follow-up of patients with cardiac implantable electronic devices. Data on paediatric populations are still lacking. The aim of our study was to follow-up young patients both in-hospital and remotely to enhance device surveillance. This is an observational registry collecting data on consecutive patients followed-up with the CareLink system. Inclusion criteria were a Medtronic device implanted and patient's willingness to receive CareLink. Patients were stratified according to age and presence of congenital/structural heart defects (CHD). A total of 221 patients with a device - 200 pacemakers, 19 implantable cardioverter defibrillators, and two loop recorders--were enrolled (median age of 17 years, range 1-40); 58% of patients were younger than 18 years of age and 73% had CHD. During a follow-up of 12 months (range 4-18), 1361 transmissions (8.9% unscheduled) were reviewed by technicians. Time for review was 6 ± 2 minutes (mean ± standard deviation). Missed transmissions were 10.1%. Events were documented in 45% of transmissions, with 2.7% yellow alerts and 0.6% red alerts sent by wireless devices. No significant differences were found in transmission results according to age or presence of CHD. Physicians reviewed 6.3% of transmissions, 29 patients were contacted by phone, and 12 patients underwent unscheduled in-hospital visits. The event recognition with remote monitoring occurred 76 days (range 16-150) earlier than the next scheduled in-office follow-up. Remote follow-up/monitoring with the CareLink system is useful to enhance device surveillance in young patients. The majority of events were not clinically relevant, and the remaining led to timely management of problems.

  18. Emphysema Quantification Using Low Dose Chest CT: Changes in Follow-Up Examinations of Asymptomatic Smokers

    Energy Technology Data Exchange (ETDEWEB)

    Jang, Eun Ho; Sun, Joo Sung; Kang, Doo Kyung [Dept. of Radiology, Ajou University School of Medicine, Suwon (Korea, Republic of); Park, Kwang Joo; Park, Kyung Joo [Dept. of Pulmolary Medicine, Ajou University School of Medicine, Suwon (Korea, Republic of)

    2012-01-15

    To evaluate the changes of emphysema quantification in a follow-up low dose CT compared with pulmonary function test (PFT) results in asymptomatic smokers. We selected 66 asymptomatic smokers (> 40 years old) who underwent a follow-up low dose CT at least one year after the first CT as well as PFT within the same time period. Emphysema quantification was performed using an automated measurement software and an emphysema index (EI) was calculated using multiple threshold values (-970--900 HU). The interval change of EI ({Delta} EI) was compared with the change in the PFT values. Mean follow-up %forced expiratory volume in 1 second (88.1), %forced vital capacity (FVC) (89.5) and forced expiratory flow between 25 and 75% of vital capacity (3.21) were significantly lower compared with the values of initial tests (93.3, 93.1, 3.48). The mean EIs (2.4-25.6%) increased on follow-up CTs compared with initial EIs (2.1-24.5%), though the increase was not statistically significant. In a group with a follow-up period of 2 years or more (n = 32), EI significantly increased when using -900 HU as the threshold. The ({Delta} EIs were poorly correlated with the ({Delta} PFT values, but significantly correlated with ({Delta} FVC (r = -0.32--0.27). Emphysema quantification using low dose CT was not effective for the evaluation of short-term changes in less than a 2-year period, but may be used for long term follow-up series in asymptomatic smokers.

  19. Seven-year follow-up of percutaneous closure of patent foramen ovale.

    Science.gov (United States)

    Mirzada, Naqibullah; Ladenvall, Per; Hansson, Per-Olof; Johansson, Magnus Carl; Furenäs, Eva; Eriksson, Peter; Dellborg, Mikael

    2013-12-01

    Observational studies favor percutaneous closure of patent foramen ovale (PFO) over medical treatment to reduce recurrent stroke while randomized trials fail to demonstrate significant superiority of percutaneous PFO closure. Few long-term studies are available post PFO closure. This study reports long-term clinical outcomes after percutaneous PFO closure. Between 1997 and 2006, 86 consecutive eligible patients with cerebrovascular events, presumably related to PFO, underwent percutaneous PFO closure. All 86 patients were invited to a long-term follow-up, which was carried out during 2011 and 2012. Percutaneous PFO closure was successfully performed in 85 of 86 patients. The follow-up rate was 100%. No cardiovascular or cerebrovascular deaths occurred. Two patients (both women) died from lung cancer during follow-up. Follow-up visits were conducted for 64 patients and the remaining 20 patients were followed up by phone. The mean follow-up time was 7.3 years (5 to 12.4 years). Mean age at PFO closure was 49 years. One patient had a minor stroke one month after PFO closure and a transient ischemic attack (TIA) two years afterwards. One other patient suffered from a TIA six years after closure. No long-term device-related complications were observed. Percutaneous PFO closure was associated with very low risk of recurrent stroke and is suitable in most patients. We observed no mortality and no long-term device-related complications related to PFO closure, indicating that percutaneous PFO closure is a safe and efficient treatment even in the long term.

  20. Follow-up of pineal cysts in children. Is it necessary?

    Energy Technology Data Exchange (ETDEWEB)

    Jussila, Miro-Pekka [Oulu University Hospital and University of Oulu, Department of Diagnostic Radiology, Oulu (Finland); Oulu University Hospital and University of Oulu, Department of Children and Adolescents, Oulu (Finland); Olsen, Paeivi [Oulu University Hospital and University of Oulu, Department of Children and Adolescents, Oulu (Finland); University of Oulu, PEDEGO Research Group, Medical Research Center, Oulu (Finland); Salokorpi, Niina [Oulu University Hospital and University of Oulu, Department of Neurosurgery, Oulu (Finland); University of Oulu, Medical Research Center, Oulu (Finland); Suo-Palosaari, Maria [Oulu University Hospital and University of Oulu, Department of Diagnostic Radiology, Oulu (Finland); University of Oulu, Medical Research Center, Oulu (Finland)

    2017-12-15

    Pineal cysts are common incidental findings in children undergoing magnetic resonance imaging (MRI). Several studies have suggested MRI follow-up if the cyst is larger than 10 mm. However, cysts do not usually change during follow-up. Prevalence, growth, and structure of the pineal cysts were analyzed to decide if follow-up MRI is necessary. A retrospective review between 2010 and 2015 was performed using 3851 MRI examinations of children aged 0-16 years to detect pineal cysts having a maximum diameter ≥ 10 mm. Eighty-one children with pineal cysts were identified and 79 of them had been controlled by MRI. Cysts were analyzed for the size, growth, and structure. A total of 1.8% of the children had a pineal cyst with a diameter ≥ 10 mm. Cysts were present in 48 girls (59.3%) and 33 boys (40.7%). Most pineal cysts (70/79) did not significantly grow during the follow-up (median 10 months, range 3-145 months). A total of 11.4% (9/79) of the cysts grew with the biggest change measured from the outer cyst wall sagittal anteroposterior dimension (mean 3.4 mm ± 1.7 mm). Only one cyst grew more than 5 mm. We found no factors correlating with the cyst growth among 9 cysts that grew > 2 mm. A majority of pineal cysts remained unchanged during the MRI follow-up. Results of this study suggest that routine MRI follow-up of pineal cysts is not necessary in the absence of unusual radiological characteristics or related clinical symptoms. (orig.)

  1. Timeliness of abnormal screening and diagnostic mammography follow-up at facilities serving vulnerable women.

    Science.gov (United States)

    Goldman, L Elizabeth; Walker, Rod; Hubbard, Rebecca; Kerlikowske, Karla

    2013-04-01

    Whether timeliness of follow-up after abnormal mammography differs at facilities serving vulnerable populations, such as women with limited education or income, in rural areas, and racial/ethnic minorities is unknown. We examined receipt of diagnostic evaluation after abnormal mammography using 1998-2006 Breast Cancer Surveillance Consortium-linked Medicare claims. We compared whether time to recommended breast imaging or biopsy depended on whether women attended facilities serving vulnerable populations. We characterized a facility by the proportion of mammograms performed on women with limited education or income, in rural areas, or racial/ethnic minorities. We analyzed 30,874 abnormal screening examinations recommended for follow-up imaging across 142 facilities and 10,049 abnormal diagnostic examinations recommended for biopsy across 114 facilities. Women at facilities serving populations with less education or more racial/ethnic minorities had lower rates of follow-up imaging (4%-5% difference, Pfacilities serving more rural and low-income populations had lower rates of biopsy (4%-5% difference, Pfacilities serving vulnerable populations had longer times until biopsy than those at facilities serving nonvulnerable populations (21.6 vs. 15.6 d; 95% confidence interval for mean difference 4.1-7.7). The proportion of women receiving recommended imaging within 11 months and biopsy within 3 months varied across facilities (interquartile range, 85.5%-96.5% for imaging and 79.4%-87.3% for biopsy). Among Medicare recipients, follow-up rates were slightly lower at facilities serving vulnerable populations, and among those women who returned for diagnostic evaluation, time to follow-up was slightly longer at facilities that served vulnerable population. Interventions should target variability in follow-up rates across facilities, and evaluate effectiveness particularly at facilities serving vulnerable populations.

  2. Factors Associated With Follow-Up Attendance Among Rape Victims Seen in Acute Medical Care.

    Science.gov (United States)

    Darnell, Doyanne; Peterson, Roselyn; Berliner, Lucy; Stewart, Terri; Russo, Joan; Whiteside, Lauren; Zatzick, Douglas

    2015-01-01

    Rape is associated with posttraumatic stress disorder (PTSD) and related comorbidities. Most victims do not obtain treatment for these conditions. Acute care medical settings are well positioned to link patients to services; however, difficulty engaging victims and low attendance at provided follow-up appointments is well documented. Identifying factors associated with follow-up can inform engagement and linkage strategies. Administrative, patient self-report, and provider observational data from Harborview Medical Center were combined for the analysis. Using logistic regression, we examined factors associated with follow-up health service utilization after seeking services for rape in the emergency department. Of the 521 diverse female (n = 476) and male (n = 45) rape victims, 28% attended the recommended medical/counseling follow-up appointment. In the final (adjusted) logistic regression model, having a developmental or other disability (OR = 0.40, 95% CI = 0.21-0.77), having a current mental illness (OR = 0.25, 95% CI = 0.13-0.49), and being assaulted in public (OR = 0.50, 95% CI = 0.28-0.87) were uniquely associated with reduced odds of attending the follow-up. Having a prior mental health condition (OR = 3.02, 95% CI = 1.86-4.91), a completed Sexual Assault Nurse Examiner's (SANE) examination (OR = 2.97, 95% CI = 1.84-4.81), and social support available to help cope with the assault (OR = 3.54, 95% CI = 1.76-7.11) were associated with an increased odds of attending the follow-up. Findings point to relevant characteristics ascertained at the acute care medical visit for rape that may be used to identify victims less likely to obtain posttraumatic medical and mental health services. Efforts to improve service linkage for these patients is warranted and may require alternative service delivery models that engage rape survivors and support posttraumatic recovery.

  3. A five-year follow-up study of Swedish adults with gender identity disorder.

    Science.gov (United States)

    Johansson, Annika; Sundbom, Elisabet; Höjerback, Torvald; Bodlund, Owe

    2010-12-01

    This follow-up study evaluated the outcome of sex reassignment as viewed by both clinicians and patients, with an additional focus on the outcome based on sex and subgroups. Of a total of 60 patients approved for sex reassignment, 42 (25 male-to-female [MF] and 17 female-to-male [FM]) transsexuals completed a follow-up assessment after 5 or more years in the process or 2 or more years after completed sex reassignment surgery. Twenty-six (62%) patients had an early onset and 16 (38%) patients had a late onset; 29 (69%) patients had a homosexual sexual orientation and 13 (31%) patients had a non-homosexual sexual orientation (relative to biological sex). At index and follow-up, a semi-structured interview was conducted. At follow-up, 32 patients had completed sex reassignment surgery, five were still in process, and five-following their own decision-had abstained from genital surgery. No one regretted their reassignment. The clinicians rated the global outcome as favorable in 62% of the cases, compared to 95% according to the patients themselves, with no differences between the subgroups. Based on the follow-up interview, more than 90% were stable or improved as regards work situation, partner relations, and sex life, but 5-15% were dissatisfied with the hormonal treatment, results of surgery, total sex reassignment procedure, or their present general health. Most outcome measures were rated positive and substantially equal for MF and FM. Late-onset transsexuals differed from those with early onset in some respects: these were mainly MF (88 vs. 42%), older when applying for sex reassignment (42 vs. 28 years), and non-homosexually oriented (56 vs. 15%). In conclusion, almost all patients were satisfied with the sex reassignment; 86% were assessed by clinicians at follow-up as stable or improved in global functioning.

  4. Randomized controlled trial of physiotherapy for postpartum stress incontinence: 7-year follow-up.

    Science.gov (United States)

    Dumoulin, Chantale; Martin, Claudine; Elliott, Valérie; Bourbonnais, Daniel; Morin, Mélanie; Lemieux, Marie-Claude; Gauthier, Robert

    2013-06-01

    To estimate the long-term effect of intensive, 6-week physiotherapy programs, with and without deep abdominal muscle (TrA) training, on persistent postpartum stress urinary incontinence (SUI). The study was a single-blind randomized controlled trial. Fifty-seven postnatal women with clinically demonstrated persistent SUI 3 months after delivery participated in 8 weeks of either pelvic floor muscle training (PFMT) (28) or PFMT with deep abdominal muscle training (PFMT + TrA) (29). Seven years post-treatment, 35 (61.4%) participants agreed to the follow-up; they were asked to complete a 20-min pad test and three incontinence-specific questionnaires with an assessor blinded to each participant's group assignment. Of the 35 (61.4%) who agreed to the follow-up: 26 (45.6%) took the 20-min pad test (12 PFMT and 14 PFMT + TrA) and 35 (61.4%) completed the questionnaires (18 PFMT and 17 PFMT + TrA). The baseline clinical characteristics of the follow-up and non-follow-up participants were not significantly different; nor did they differ between PFMT and PFMT + TrA participants enrolled in the follow-up study. At 7 years, the pad test scores for the PFMT group did not differ statistically from those of the PFMT + TrA group. When combining both treatment groups, a total of 14/26 (53%) follow-up participants were still continent according to the pad test. The addition of deep abdominal training does not appear to further improve the outcome of PFM training in the long term. However, benefits of physiotherapy for postpartum SUI, although not as pronounced as immediately after the initial intervention, is still present 7 years post-treatment. Copyright © 2013 Wiley Periodicals, Inc.

  5. Automated detection of follow-up appointments using text mining of discharge records.

    Science.gov (United States)

    Ruud, Kari L; Johnson, Matthew G; Liesinger, Juliette T; Grafft, Carrie A; Naessens, James M

    2010-06-01

    To determine whether text mining can accurately detect specific follow-up appointment criteria in free-text hospital discharge records. Cross-sectional study. Mayo Clinic Rochester hospitals. Inpatients discharged from general medicine services in 2006 (n = 6481). Textual hospital dismissal summaries were manually reviewed to determine whether the records contained specific follow-up appointment arrangement elements: date, time and either physician or location for an appointment. The data set was evaluated for the same criteria using SAS Text Miner software. The two assessments were compared to determine the accuracy of text mining for detecting records containing follow-up appointment arrangements. Agreement of text-mined appointment findings with gold standard (manual abstraction) including sensitivity, specificity, positive predictive and negative predictive values (PPV and NPV). About 55.2% (3576) of discharge records contained all criteria for follow-up appointment arrangements according to the manual review, 3.2% (113) of which were missed through text mining. Text mining incorrectly identified 3.7% (107) follow-up appointments that were not considered valid through manual review. Therefore, the text mining analysis concurred with the manual review in 96.6% of the appointment findings. Overall sensitivity and specificity were 96.8 and 96.3%, respectively; and PPV and NPV were 97.0 and 96.1%, respectively. of individual appointment criteria resulted in accuracy rates of 93.5% for date, 97.4% for time, 97.5% for physician and 82.9% for location. Text mining of unstructured hospital dismissal summaries can accurately detect documentation of follow-up appointment arrangement elements, thus saving considerable resources for performance assessment and quality-related research.

  6. Adherence to Follow-up Recommendations Among Individuals in the Philadelphia Glaucoma Detection and Treatment Project.

    Science.gov (United States)

    Hark, Lisa A; Leiby, Benjamin E; Waisbourd, Michael; Myers, Jonathan S; Fudemberg, Scott J; Mantravadi, Anand V; Dai, Yang; Gilligan, John P; Resende, Arthur F; Katz, L Jay

    2017-08-01

    To evaluate rates of adherence to free follow-up eye exam appointments among participants in the Philadelphia Glaucoma Detection and Treatment Project. Ophthalmologists and testing equipment were brought directly to participants at risk for glaucoma at 43 community sites in Philadelphia. Those diagnosed with glaucoma-related pathology were recommended to return for follow-up to be reexamined on site. Rates of adherence and clinical and demographic risk factors for adherence were evaluated. Five hundred thirty-one participants were diagnosed with glaucoma-related conditions and recommended to attend community-based follow-up exams. Follow-up adherence rate was 61.2% (n=325/531). Significant factors associated with greater eye exam appointment adherence, based on our univariable analysis, included final diagnosis of glaucoma (risk ratio [RR]=1.33; 95% confidence interval [CI], 1.13-1.57), male sex (RR=1.19; 95% CI, 1.04-1.36), white race (RR=1.26; 95% CI, 1.08-1.48), age (RR=1.17; 95% CI, 1.00-1.37) recommendation for glaucoma medication (RR=1.52; 95% CI, 1.35-1.71), recommendation for laser peripheral iridotomy (RR=1.18; 95% CI, 1.02-1.35), diagnosis of age-related macular degeneration (RR=1.42; 95% CI, 1.13-1.77) and an increased intraocular pressure (>22 mm Hg in the worse eye) (RR=1.23; 95% CI, 1.06-1.42). On the basis of our multivariable model, diagnosis, sex, and recommended glaucoma medications were significantly associated with follow-up adherence. This study demonstrates that individuals living in underserved urban communities would take advantage of free eye exams in community sites and return for follow-up eye exams in these same settings. Future studies could investigate interventions to improve eye exam appointment adherence in community-based settings to detect glaucoma-eye conditions.

  7. Disparities in Barriers to Follow-up Care between African American and White Breast Cancer Survivors

    Science.gov (United States)

    Palmer, Nynikka R. A.; Weaver, Kathryn E.; Hauser, Sally P.; Lawrence, Julia A.; Talton, Jennifer; Case, L. Douglas; Geiger, Ann M.

    2015-01-01

    Purpose Despite recommendations for breast cancer survivorship care, African American women are less likely to receive appropriate follow-up care, which is concerning due to their higher mortality rates. This study describes differences in barriers to follow-up care between African American and White breast cancer survivors. Methods We conducted a mailed survey of women treated for non-metastatic breast cancer in 2009–2011, 6–24 months post-treatment (N=203). Survivors were asked about 14 potential barriers to follow-up care. We used logistic regression to explore associations between barriers and race, adjusting for covariates. Results Our participants included 31 African American and 160 White survivors. At least one barrier to follow-up care was reported by 62%. Compared to White survivors, African Americans were more likely to identify barriers related to out-of-pocket costs (28% vs. 51.6%, p=0.01), other healthcare costs (21.3% vs. 45.2%, p=0.01), anxiety/worry (29.4% vs. 51.6%, p=0.02), and transportation (4.4% vs. 16.1%, p=0.03). After adjustment for covariates, African Americans were three times as likely to report at least one barrier to care (OR=3.3, 95%CI=1.1–10.1). Conclusions Barriers to care are common among breast cancer survivors, especially African American women. Financial barriers to care may prevent minority and underserved survivors from accessing follow-up care. Enhancing insurance coverage or addressing out-of-pocket costs may help address financial barriers to follow-up care among breast cancer survivors. Psychosocial care aimed at reducing fear of recurrence may also be important to improve access among African American breast cancer survivors. PMID:25821145

  8. Survival analysis with functional covariates for partial follow-up studies.

    Science.gov (United States)

    Fang, Hong-Bin; Wu, Tong Tong; Rapoport, Aaron P; Tan, Ming

    2016-12-01

    Predictive or prognostic analysis plays an increasingly important role in the era of personalized medicine to identify subsets of patients whom the treatment may benefit the most. Although various time-dependent covariate models are available, such models require that covariates be followed in the whole follow-up period. This article studies a new class of functional survival models where the covariates are only monitored in a time interval that is shorter than the whole follow-up period. This paper is motivated by the analysis of a longitudinal study on advanced myeloma patients who received stem cell transplants and T cell infusions after the transplants. The absolute lymphocyte cell counts were collected serially during hospitalization. Those patients are still followed up if they are alive after hospitalization, while their absolute lymphocyte cell counts cannot be measured after that. Another complication is that absolute lymphocyte cell counts are sparsely and irregularly measured. The conventional method using Cox model with time-varying covariates is not applicable because of the different lengths of observation periods. Analysis based on each single observation obviously underutilizes available information and, more seriously, may yield misleading results. This so-called partial follow-up study design represents increasingly common predictive modeling problem where we have serial multiple biomarkers up to a certain time point, which is shorter than the total length of follow-up. We therefore propose a solution to the partial follow-up design. The new method combines functional principal components analysis and survival analysis with selection of those functional covariates. It also has the advantage of handling sparse and irregularly measured longitudinal observations of covariates and measurement errors. Our analysis based on functional principal components reveals that it is the patterns of the trajectories of absolute lymphocyte cell counts, instead of

  9. Patients with computed tomography-proven acute diverticulitis require follow-up to exclude colorectal cancer

    Directory of Open Access Journals (Sweden)

    Shafquat Zaman

    2017-04-01

    Full Text Available Background/Aims: Traditionally, patients with acute diverticulitis undergo follow-up endoscopy to exclude colorectal cancer (CRC. However, its usefulness has been debated in this era of high-resolution computed tomography (CT diagnosis. We assessed the frequency and outcome of endoscopic follow-up for patients with CT-proven acute diverticulitis, according to the confidence in the CT diagnosis.Methods: Records of patients with CT-proven acute diverticulitis between October 2007 and March 2014 at Sandwell & West Birmingham Hospitals NHS Trust were retrieved. The National Cancer Registry confirmed the cases of CRC. Endoscopy quality indicators were compared between these patients and other patients undergoing the same endoscopic examination over the same period.Results: We identified 235 patients with CT-proven acute diverticulitis, of which, 187 were managed conservatively. The CT report was confident of the diagnosis of acute diverticulitis in 75% cases. Five of the 235 patients were subsequently diagnosed with CRC (2.1%. Three cases of CRC were detected in the 187 patients managed conservatively (1.6%. Forty-eight percent of the conservatively managed patients underwent follow-up endoscopy; one case of CRC was identified. Endoscopies were often incomplete and caused more discomfort for patients with diverticulitis compared with controls.Conclusions: CRC was diagnosed in patients with CT-proven diverticulitis at a higher rate than in screened asymptomatic populations, necessitating follow-up. CT reports contained statements regarding diagnostic uncertainty in 25% cases, associated with an increased risk of CRC. Follow-up endoscopy in patients with CT-proven diverticulitis is associated with increased discomfort and high rates of incompletion. The use of other follow-up modalities should be considered.

  10. The effect of race on postsurgical ambulatory medical follow-up among United States Veterans.

    Science.gov (United States)

    Schonberger, Robert B; Dai, Feng; Brandt, Cynthia; Burg, Matthew M

    2017-08-01

    To investigate the association between self-identified black or African American race and the presence of ambulatory internal medicine follow-up in the year after surgery. Our hypothesis was that among US Veterans who presented for surgery, black or African American race would be associated with a decreased likelihood to receive ambulatory internal medicine follow-up in the year after surgery. Retrospective observational. All US Veterans Affairs hospitals. A total of 236,200 Veterans undergoing surgery between 2006 and 2011 who were discharged within 10 days of surgery and survived the full 1-year exposure period. None. Attendance at an internal medicine follow-up appointment within 1 year after surgery. After controlling for year of surgery, age, age ≥65 years, sex, Hispanic ethnicity, and number of inpatient days, black or African American patients were 11% more likely to lack internal medicine follow-up after surgery (adjusted odds ratio, 1.11; 95% confidence interval, 1.06-1.16). When accounting for geographic region, this difference remained significant at the Bonferoni-corrected P < .007 level only in the Midwest United States where black or African American patients were 28% more likely to lack medical follow-up in the year after surgery (odds ratio, 1.28; 95% confidence interval, 1.16-1.42; P < .0001). The disparity in ambulatory medical follow-up following surgery among black or African American vs nonblack or non-African American Veterans in the Midwest region deserves further study and may lead to important quality improvement initiatives aimed specifically at this population. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Obese patients lose weight independently of nutritional follow-up after bariatric surgery

    Directory of Open Access Journals (Sweden)

    Beatriz Helena Tess

    2015-04-01

    Full Text Available Summary Objective: to examine the association between preoperative body weight, adherence to postsurgical nutritional follow-up, length of postoperative period, and weight loss during the first 18 months among adults who have undergone bariatric surgery. Methods: a retrospective cohort study was conducted on 241 consecutive patients who underwent open Roux-en-Y gastric bypass (RYGBP from January 2006 to December 2008, in a teaching hospital in São Paulo (Brazil. Data were collected through hospital records review and the variables analyzed included sex, age, immediate preoperative weight, adherence to postsurgical nutritional visits and length of postoperative period. Proportional body weight reductions during the 18-month follow-up period were examined using generalized estimating equations. Results: 81% (n=195 of participants were female, with overall mean age of 44.4 ± 11.6 years, mean preoperative weight of 123.1± 21.2 kg and mean preoperative body mass index of 47.2± 6.2 kg/m2. The overall adherence to postoperative follow- up schedule was 51% (95%CI: 44.5-57.5%. Preoperative body weight and adherence were not associated with proportional weight reduction (Wald’s test p > 0.18. Weight loss leveled off at the end of the 18-month follow-up period for both compliant and non-compliant patients (Wald’s test p = 0.00. Conclusions: our study showed that weight loss occurred steadily over the first 18 months after RYGBP, leveling off at around 40% weight reduction. It was associated with neither presurgical weight, nor nutritional follow-up and it may be primarily dependent on the surgical body alterations themselves. This finding may have implications for intervention strategies aimed at motivating patients to comply with early postsurgical and life-long follow-up.

  12. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study.

    Science.gov (United States)

    O'Brien, Susan; Jones, Jeffrey A; Coutre, Steven E; Mato, Anthony R; Hillmen, Peter; Tam, Constantine; Österborg, Anders; Siddiqi, Tanya; Thirman, Michael J; Furman, Richard R; Ilhan, Osman; Keating, Michael J; Call, Timothy G; Brown, Jennifer R; Stevens-Brogan, Michelle; Li, Yunfeng; Clow, Fong; James, Danelle F; Chu, Alvina D; Hallek, Michael; Stilgenbauer, Stephan

    2016-10-01

    The TP53 gene, encoding tumour suppressor protein p53, is located on the short arm of chromosome 17 (17p). Patients with 17p deletion (del17p) chronic lymphocytic leukaemia have poor responses and survival after chemoimmunotherapy. We assessed the activity and safety of ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase, in relapsed or refractory patients with del17p chronic lymphocytic leukaemia or small lymphocytic lymphoma. We did a multicentre, international, open-label, single-arm study at 40 sites in the USA, Canada, Europe, Australia, and New Zealand. Patients (age ≥18 years) with previously treated del17p chronic lymphocytic leukaemia or small lymphocytic lymphoma received oral ibrutinib 420 mg once daily until progressive disease or unacceptable toxicity. The primary endpoint was overall response in the all-treated population per International Workshop on Chronic Lymphocytic Leukaemia 2008 response criteria modified for treatment-related lymphocytosis. Preplanned exploratory analyses were progression-free survival, overall survival, sustained haematological improvement, and immunological improvement. Patient enrolment is complete, but follow-up is ongoing. Treatment discontinuation owing to adverse events, unacceptable toxicity, or death were collected as a single combined category. This study is registered with ClinicalTrials.gov, number NCT01744691. Between Jan 29, 2013, and June 19, 2013, 145 patients were enrolled. The all-treated population consisted of 144 patients with del17p chronic lymphocytic leukaemia or small lymphocytic lymphoma who received at least one dose of study drug, with a median age of 64 years (IQR 57-72) and a median of two previous treatments (IQR 1-3). At the prespecified primary analysis after a median follow-up of 11·5 months (IQR 11·1-13·8), 92 (64%, 95% CI 56-71) of 144 patients had an overall response according to independent review committee assessment; 119 patients (83%, 95% CI 76-88) had an overall

  13. Follow-up of the ovarial carcinoma from the point of view of the gynecologist

    International Nuclear Information System (INIS)

    Vahrson, H.

    1983-01-01

    A co-operation between the different institutions and doctors and the tumor centre is indispensable for an adequate follow-up of the ovarial carcinoma. Besides diagnosis and therapy of side effects of the treatment as well as early diagnosis of recurrences, a psychical and social care is particularly necessary. The follow-up treatment aims at a full social rehabilitation of probably cured patients and, in case of incurable patients, at a relief of pain until death. The determination of t-RNA as a reliable tumor marker and the examinations necessary for routine controls (minimal and maximal programme) are indicated. (orig.) [de

  14. CYSTINURIA - A TEN-YEAR FOLLOW-UP OF THE PATIENTS

    Directory of Open Access Journals (Sweden)

    Anđelka Slavković

    2001-09-01

    Full Text Available In the period from 1991 to 2001 there were four patients followed up who suffered from cystinuria and cystine calcinosis. The therapy consisting of the cystine dilution in the urine by a great taking-in of liquids and the urine alkalization was combined with alphamercaptopropione glycine and captoprile that bind cystine as well as a respective diet. Alphamercaptopropione glycine leads to the reduction of the already-formed calculus and their easier treatment in the case of a possible need for extracorporeal lithotripsy (ESWEL. During the ten-year follow-up of a small series of patients there were no complications related to the medicament treatment.

  15. Treatment and follow-up of children with common chronic liver diseases in children

    Directory of Open Access Journals (Sweden)

    LYU Xintong

    2017-10-01

    Full Text Available Chronic liver diseases in children greatly affect their growth and development and quality of life in future. There are many causes of chronic liver diseases in children, and such causes, diet, and treatment guidance are closely associated with prognosis. This article discusses the guidance and follow-up of common chronic liver diseases in children, such as infantile cholestatic liver disease, chronic hepatitis B, hepatolenticular degeneration, and nonalcoholic fatter liver disease, in order to deepen the understanding of these diseases among patients, raise the awareness of follow-up in medical staff, and improve the cure rate of liver diseases with different causes and children’s quality of life.

  16. Hepatic pseudoaneurysm after traumatic liver injury; is CT follow-up warranted?

    DEFF Research Database (Denmark)

    Østerballe, Lene; Helgstrand, Frederik; Axelsen, Thomas

    2014-01-01

    INTRODUCTION: Hepatic pseudoaneurysm (HPA) is a rare complication after liver trauma, yet it is potentially fatal, as it can lead to sudden severe haemorrhage. The risk of developing posttraumatic HPA is one of the arguments for performing follow-up CT of patients with liver injuries. The aim...... no treatment failures. There was no correlation between the severity of the liver injury and development of HPA. 5 out of 7 patients were asymptomatic and would have been discharged without treatment if the protocol did not include a default follow-up CT. CONCLUSIONS: In conclusion, this study shows that HPA...

  17. Irritable bowel syndrome--prognosis and diagnostic safety. A 5-year follow-up study

    DEFF Research Database (Denmark)

    Svendsen, Jesper Hastrup; Munck, L K; Andersen, J R

    1985-01-01

    The irritable bowel syndrome is the commonest diagnosis in gastroenterological clinics, although diagnostic criteria and investigatory programs vary. To elucidate the diagnostic safety and prognosis of the syndrome, a retrospective study was conducted. One hundred and twelve consecutive patients...... with irritable bowel syndrome as the final and only abdominal diagnosis in the period 1977-79 were followed up in 1984. Seventeen patients died during the follow-up period; two of these were considered diagnostic failures (chronic pancreatitis and pancreatic cancer). Of the remaining 95 patients, 93 were...

  18. Pulmonary function and autoantibodies in a long-term follow-up of juvenile dermatomyositis patients

    DEFF Research Database (Denmark)

    Mathiesen, Pernille Raasthøj; Buchvald, Frederik Fouirnaies; Nielsen, Kim G

    2014-01-01

    outcome, and (iii) identify possible associations between pulmonary impairment and myositis-specific autoantibodies (MSAs).Methods. Fifty-one JDM patients performed conventional spirometry in a cross-sectional follow-up study. The scores of the Myositis Damage Index (MDI), Myositis Damage by visual...... analogue scale (MYODAM-VAS) and physician's global damage assessment were used to estimate JDM outcome. ANAs, MSAs and myositis-associated autoantibodies were analysed in all patients.Results. Forty-two patients (82%) (mean follow-up time 14.3 years) had normal lung function. Four patients (8%) were...

  19. Socioeconomic position and participation in baseline and follow-up visits

    DEFF Research Database (Denmark)

    Bender, Anne M; Jørgensen, Torben; Hansen, Bodil Helbech

    2012-01-01

    Background:The aim of this paper was to identify the extent of socioeconomic inequality in participation at baseline and follow-up visits.Design:The Inter99 study is a randomized intervention with the aim of investigating the effects of an individualized lifestyle consultation on ischaemic heart ...... inequality in participation at baseline and follow-up visits. Effort should be made to increase participation in individualized lifestyle interventions among persons of low socioeconomic position. Otherwise, the consequence may be increased socioeconomic inequality in IHD....

  20. Pediatric vocal fold immobility: natural history and the need for long-term follow-up.

    Science.gov (United States)

    Jabbour, Jad; Martin, Timothy; Beste, David; Robey, Thomas

    2014-05-01

    IMPORTANCE The clinical course and outcomes of pediatric vocal fold immobility (VFI) vary widely in the literature, and follow-up in these patients varies accordingly. A better understanding of the natural history of pediatric VFI is crucial to improved management. OBJECTIVE To characterize the natural history of pediatric VFI, including symptoms and rates of resolution and surgical intervention. DESIGN, SETTING, AND PARTICIPANTS Retrospective review at an academically affiliated private pediatric otolaryngology practice in a metropolitan area of all patients seen between July 15, 2001, and September 1, 2012, with a diagnosis of complete or partial VFI. After elimination of 92 incomplete or duplicate files, 404 patient records were reviewed for demographic characteristics, etiologies, symptoms, follow-up, resolution, and interventions. Follow-up records were available for 362 patients (89.6%). MAIN OUTCOMES AND MEASURES Resolution of VFI confirmed by repeated laryngoscopy, length of follow-up, and surgical intervention rates. RESULTS Among the 404 patients, left VFI was present in 66.8%, right VFI in 7.9%, and bilateral VFI in 25.3%. Median (range) age at presentation was 2.9 (0-528.1) months. Major etiological categories included cardiac surgery in 68.8%, idiopathic immobility in 21.0%, and neurologic disease in 7.4%. At presentation, 61.4%experienced dysphonia, 54.0%respiratory symptoms, and 49.5%dysphagia. Tracheotomy was performed in 25.7%and gastrostomy in 40.8%. Median (range) duration of follow-up among the 89.6%of patients with follow-up was 17.2 (0.2-173.5) months. Resolution evidenced by laryngoscopy was found in 28.0%, with a median (range) time to resolution of 4.3 (0.4-38.7) months. In patients without laryngoscopic resolution, median follow-up was 26.0 months, and 28.9% reported symptomatic resolution. CONCLUSIONS AND RELEVANCE The natural history of pediatric VFI involves substantial morbidity, with lasting symptoms and considerable rates of surgical

  1. Predictors of Attendance and Dropout at the Lung Health Study 11-Year Follow-Up

    OpenAIRE

    Snow, Wanda M.; Connett, John E.; Sharma, Shweta; Murray, Robert P.

    2006-01-01

    Participant attrition and attendance at follow-up were examined in a multicenter, randomized, clinical trial. The Lung Health Study (LHS) enrolled a total of 5, 887 adults to examine the impact of smoking cessation coupled with the use of an inhaled bronchodilator on chronic obstructive pulmonary disease (COPD). Of the initial LHS 1 volunteers still living at the time of enrolment in LHS 3 (5,332), 4,457 (84%) attended the LHS 3 clinic visit, a follow-up session to determine current smoking s...

  2. The importance of complete follow-up for results after femoro-infrapopliteal vascular surgery

    DEFF Research Database (Denmark)

    Jensen, L P; Nielsen, O M; Schroeder, T V

    1996-01-01

    intervals and all data have been recorded prospectively in a vascular registry. As part of a randomised trial on adjuvant medication in femorocrural bypass surgery, 102 patients, operated on between 1990 and 1992 were independently and simultaneously monitored. This subgroup was examined at 3 and 12 months...... is lost to follow-up, since failure to examine the patient for any reason may be related to the patients health. In addition to the number of patients at risk, it is suggested, that life-table plots should be supplemented with information on the number of patients lost to follow-up....

  3. Clinical and radiological follow-up examinations following fractures of the Collum mandibulae

    International Nuclear Information System (INIS)

    Guss, K.

    1981-01-01

    All patients presented a fracture of the collum mandibulae, which had occurred between 1 and 10 years before treatment. The patients were exclusively treated conservatively. 57 of 67 patients did not indicate any subjective pain. 10 patients complained about pain and restricted movability. In only 22 cases no pathologic findings were obtained in the clinical follow-up examinations. In 33 patients the roentgenologic follow-up examination led to pathologic findings. Severe complications as disturbance of growth and formation of ankyloses, occurred only in one single case, due to a fracture of the mandibular joint in childhood. (orig./MG) [de

  4. Scandinavian Clinical Practice Guidelines on the diagnosis, management and follow-up of anaphylaxis during anaesthesia

    DEFF Research Database (Denmark)

    Kroigaard, M; Garvey, L H; Gillberg, L

    2007-01-01

    to the rare and unforeseeable nature of anaphylaxis, mainly includes case series and expert opinion (grade of evidence IV and V). These guidelines include an overview of the epidemiology of anaphylactic reactions during anaesthesia. A treatment algorithm is suggested, with emphasis on the incremental...... advice concerning follow-up procedures is provided. In addition, an algorithm is included with advice on how to manage patients with previous suspected anaphylaxis during anaesthesia. Lastly, Appendix 2 provides an overview of the incidence, mechanisms and possibilities for follow-up for some common drug...

  5. Outpatient follow-up system using a personal computer for patients with hepatocellular carcinoma after surgery.

    Science.gov (United States)

    Itasaka, H; Matsumata, T; Taketomi, A; Yamamoto, K; Yanaga, K; Takenaka, K; Akazawa, K; Sugimachi, K

    1994-12-01

    A simple outpatient follow-up system was developed with a laptop personal computer to assist management of patients with hepatocellular carcinoma after hepatic resections. Since it is based on a non-relational database program and the graphical user interface of Macintosh operating system, those who are not a specialist of the computer operation can use it. It is helpful to promptly recognize current status and problems of the patients, to diagnose recurrences of the disease and to prevent lost from follow-up cases. A portability of the computer also facilitates utilization of these data everywhere, such as in clinical conferences and laboratories.

  6. FOLLOW-UP DATA ON 179 DANISH CHILDREN AFTER THEIR FIRST PYELONEPHRITIS

    DEFF Research Database (Denmark)

    Breinbjerg, Anders; Kamperis, Konstantinos; Frøkjær, Jørgen

    Introduction: Controversy exists regarding follow-up investigations in children diagnosed with their first pyelonephritis. In our centre children with upper urinary tract infections are subjected to a DMSA or MAG3 scan to assess renal parenchymal damage app. 6 months following the UTI. We aimed...... to analyse follow-up data on 179 consecutive Danish children after their first pyelonephritis. Material and methods:We examined the records of children diagnosed with their first upper UTI confirmed by urine culture during the years 2011-2013.We collected data on the clinical course of the pyelonephritis...

  7. Effects of quetiapine and olanzapine in patients with psychosis and violent behavior: a pilot randomized, open-label, comparative study

    Directory of Open Access Journals (Sweden)

    Gobbi G

    2014-05-01

    Full Text Available Gabriella Gobbi,1,2 Stefano Comai,1 Guy Debonnel1,2,† 1Neurobiological Psychiatric Unit, Department of Psychiatry, McGill University and McGill University Health Center, 2Institut Philippe Pinel, Department of Psychiatry, Université de Montréal, Montréal, QC, Canada †Guy Debonnel passed away on November 4, 2006 Objective: Patients suffering from psychosis are more likely than the general population to commit aggressive acts, but the therapeutics of aggressive behavior are still a matter of debate. Methods: This pilot randomized, open-label study compared the efficacy of quetiapine versus olanzapine in reducing impulsive and aggressive behaviors (primary endpoints and psychotic symptoms (secondary endpoints from baseline to days 1, 7, 14, 28, 42, 56, and 70, in 15 violent schizophrenic patients hospitalized in a maximum-security psychiatric hospital. Results: Quetiapine (525±45 mg and olanzapine (18.5±4.8 mg were both efficacious in reducing Impulsivity Rating Scale from baseline to day 70. In addition, both treatments reduced the Brief Psychiatric Rating Scale, Positive and Negative Syndrome Scale, and Clinical Global Impression Scale scores at day 70 compared to baseline, and no differences were observed between treatments. Moreover, quetiapine, but not olanzapine, yielded an improvement of depressive symptoms in the items “depression” in Brief Psychiatric Rating Scale and “blunted affect” in Positive and Negative Syndrome Scale. Modified Overt Aggression Scale scores were also decreased from baseline to the endpoint, but due to the limited number of patients, it was not possible to detect a significant difference. Conclusion: In this pilot study, quetiapine and olanzapine equally decreased impulsive and psychotic symptoms after 8 weeks of treatment. Double-blind, large studies are needed to confirm the validity of these two treatments in highly aggressive and violent schizophrenic patients. Keywords: schizophrenia, aggression

  8. Eplerenone for early cardiomyopathy in Duchenne muscular dystrophy: results of a two-year open-label extension trial

    Directory of Open Access Journals (Sweden)

    Subha V. Raman

    2017-02-01

    Full Text Available Abstract Background Cardiomyopathy is a leading cause of morbidity and mortality in boys with Duchenne muscular dystrophy (DMD. We recently showed in a 12-month double-blind randomized controlled trial that adding eplerenone to background medical therapy was cardioprotective in this population. The objective of this study was to evaluate the safety and efficacy of longer-term eplerenone therapy in boys with DMD. Results Eleven subjects (phase 1 baseline median [range] age: 13 [7 – 25] years from the original 12-month trial at a single participating center were enrolled. Importantly, those who entered the extension study who had been on eplerenone previously were significantly older than those who had originally been on placebo (median age 10.5 vs. 18.0 years, p = 0.045. During an additional 24-month open-label extension study, all boys received eplerenone 25 mg orally once daily to treat preclinical DMD cardiomyopathy, defined as evident myocardial damage by late gadolinium enhancement cardiac magnetic resonance (LGE with preserved ejection fraction (EF. The threshold for potassium level, the primary safety measure, was not exceeded in any non-hemolyzed blood sample. Over 24 months, left ventricular (LV systolic strain, a more sensitive marker whose more negative values indicate greater contractility significantly improved (median change -4.4%, IQR -5.8 to -0.9% in younger subjects whereas older subjects’ strain remained stable without significant worsening or improvement (median change 0.2%, IQR -1.1 to 4.3%. EF and extent of myocardial damage by LGE remained stable in both groups over 2 years. Conclusions Eplerenone offers effective and safe cardioprotection for boys with DMD, particularly when started at a younger age. Eplerenone is a useful clinical therapeutic option, particularly if treatment is initiated earlier in life when cardiac damage is minimal. Trial registration http://ClinicalTrials.gov identifier NCT01521546

  9. An instrument assessing satisfaction with iron chelation therapy: Psychometric testing from an open-label clinical trial.

    Science.gov (United States)

    Rofail, Diana; Viala, Muriel; Gater, Adam; Abetz-Webb, Linda; Baladi, Jean-Francois; Cappellini, Maria Domenica

    2010-08-01

    The Satisfaction with Iron Chelation Therapy (SICT) instrument was developed based on a literature review, in-depth patient and clinician interviews, and cognitive debriefing interviews. An, open-label, single arm, multicenter trial evaluating the efficacy and safety of deferasirox in patients diagnosed with transfusion-dependent iron overload, provided an opportunity to assess the psychometric measurement properties of the instrument. Psychometric analyses were performed using data at baseline from 273 patients with a range of transfusion-dependent iron overload conditions who were participating in a multinational study. Responsiveness was further evaluated for all patients who also had subsequent satisfaction domain scores collected at week 4. Baseline SICT domain scores had acceptable floor and ceiling effects and internal consistency reliability (Cronbach's alpha: 0.75-0.85). Item discriminant and item convergent validity were both excellent although one item in each analysis did not meet the specified criterion. Small to moderate correlations were observed between SICT and Short Form 36 Health Survey (SF-36) domain scores. Patients with the highest levels of serum ferritin at baseline (>3100 ng/mL) were the least satisfied about the Perceived Effectiveness of ICT and vice versa. Satisfaction improved in all patients, although there were no clear differences observed between groups of patients defined according to changes in serum ferritin levels from baseline to week 4 (stable, improved, or worsened). The SICT domains are reliable and valid. Further testing using a more specific criterion (such as assessing patient global ratings of change in satisfaction domains that correspond to the SICT domains) could help to establish with greater confidence the responsiveness of the instrument.

  10. Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study.

    Science.gov (United States)

    Kobalava, Zhanna; Villevalde, Svetlana; Kotovskaya, Yulia; Hinrichsen, Holger; Petersen-Sylla, Marc; Zaehringer, Andreas; Pang, Yinuo; Rajman, Iris; Canadi, Jasna; Dahlke, Marion; Lloyd, Peter; Halabi, Atef

    2015-06-01

    Serelaxin is a recombinant form of human relaxin-2 in development for treatment of acute heart failure. This study aimed to evaluate the pharmacokinetics (PK) of serelaxin in patients with hepatic impairment. Secondary objectives included evaluation of immunogenicity, safety and tolerability of serelaxin. This was an open-label, parallel group study (NCT01433458) comparing the PK of serelaxin following a single 24 h intravenous (i.v.) infusion (30 μg kg(-1)  day(-1) ) between patients with mild, moderate or severe hepatic impairment (Child-Pugh class A, B, C) and healthy matched controls. Blood sampling and standard safety assessments were conducted. Primary non-compartmental PK parameters [including area under the serum concentration-time curve AUC(0-48 h) and AUC(0-∞) and serum concentration at 24 h post-dose (C24h )] were compared between each hepatic impairment group and healthy controls. A total of 49 subjects (including 25 patients with hepatic impairment) were enrolled, of which 48 subjects completed the study. In all groups, the serum concentration of serelaxin increased over the first few hours of infusion, reached steady-state at 12-24 h and then declined following completion of infusion, with a mean terminal half-life of 7-8 h. All PK parameter estimates were comparable between each group of patients with hepatic impairment and healthy controls. No serious adverse events, discontinuations due to adverse events or deaths were reported. No serelaxin treatment-related antibodies developed during this study. The PK and safety profile of serelaxin were not affected by hepatic impairment. No dose adjustment is needed for serelaxin treatment of 48 h i.v. infusion in patients with hepatic impairment. © 2014 The British Pharmacological Society.

  11. Influence of Renal Impairment on the Pharmacokinetics of Afatinib: An Open-Label, Single-Dose Study.

    Science.gov (United States)

    Wiebe, Sabrina; Schnell, David; Külzer, Raimund; Gansser, Dietmar; Weber, Anne; Wallenstein, Gudrun; Halabi, Atef; Conrad, Anja; Wind, Sven

    2017-06-01

    Afatinib is an oral irreversible ErbB-Family Blocker indicated for treatment of patients with EGFR mutation positive advanced non-small cell lung cancer. This trial assessed whether renal impairment influences the pharmacokinetics and safety of afatinib. This was an open-label, single-dose study. Pharmacokinetic parameters after afatinib 40 mg were investigated in subjects with moderate (n = 8) or severe (n = 8) renal impairment (estimated glomerular filtration rate 30-59 mL/min/1.73 m 2 and 15-29 mL/min/1.73 m 2 , respectively) and healthy matched controls (n = 14). Plasma and urine samples were collected before and up to 14 days after dosing for pharmacokinetic and plasma protein-binding assessment. Primary endpoints were area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC last ) and maximum plasma concentration (C max ) between subjects with renal impairment and healthy matched controls. Pharmacokinetic profiles and plasma protein binding were similar in all groups. The extent of exposure, as indicated by AUC last and C max , was generally similar between the matched treatment groups, with the exception of the geometric mean ratio of AUC last for subjects with severe renal impairment, which showed a trend towards a higher value compared with matched healthy subjects (150.0 % [90 % CI 105.3-213.7]) Inter-individual variability was moderate (geometric mean coefficient of variation 28-39 % for moderate impairment, 34-42 % for severe impairment). Afatinib was well tolerated and urinary excretion was minimal. Moderate-to-severe renal impairment had a minor influence on the pharmacokinetics of afatinib that was within the observed inter-individual variability, suggesting that afatinib treatment can be considered in this patient population. Registered at ClinicalTrials.gov as NCT02096718.

  12. The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study.

    Science.gov (United States)

    Yataba, Ikuko; Otsuka, Noboru; Matsushita, Isao; Matsumoto, Hideo; Hoshino, Yuichi

    2016-08-01

    The newly developed S-flurbiprofen plaster (SFPP) is a tape-type patch that shows innovative percutaneous absorption. This study was designed to evaluate the safety of a long-term 52-week SFPP application to osteoarthritis (OA) patients. This was a multi-center, open-label, uncontrolled prospective study that included 201 OA patients. SFPP at 40 mg/day was applied to the site of pain in 101 patients and at 80 mg/day (2 patches) in 100 patients at a total of 301 sites for 52 weeks. The affected sites assessed included the knee (192), lumbar spine (66), cervical spine (26), and others (17). Drug safety was evaluated by medical examination, laboratory tests, and examination of vital signs. Efficacy was evaluated by the patient's and clinician's global assessments and clinical symptoms. Most patients (80.1 %) completed the 52-week SFPP application. The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46.8 % of the sites. No photosensitive dermatitis was observed. Systemic AEs occurred in 9.0 % of the patients; a serious AE (gastric ulcer hemorrhage) occurred in one patient. No clinically significant changes in the laboratory tests and vital signs were observed. The efficacy evaluation showed an improvement from 2 weeks after the SFPP application, which continued during the 52 weeks' treatment. No apparent safety concerns were observed, even during the long-term SFPP application. Therefore, SFPP could be an additional pharmacotherapy in OA treatment.

  13. Green tea (Camellia sinensis) for patients with knee osteoarthritis: A randomized open-label active-controlled clinical trial.

    Science.gov (United States)

    Hashempur, Mohammad Hashem; Sadrneshin, Sara; Mosavat, Seyed Hamdollah; Ashraf, Alireza

    2018-02-01

    Green tea is known as a dietary supplement and a novel functional food worldwide. Since there are increasing preclinical evidence about efficacy of green tea for treating osteoarthritis, this study has aimed at assessing its efficacy and safety for patients with knee osteoarthritis. This is a randomized open-label active-controlled clinical trial. As many as fifty adults with osteoarthritis of knee were randomly allocated to receive the green tea extract (in dosage form of tablet) plus diclofenac tablet as "intervention group"; or: diclofenac tablet alone as "control group" for a period of four weeks. Patients were assessed at the beginning of intervention, and then 4 weeks later, in terms of pain score via visual analogue scale (VAS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire's total score in addition to its 3 sub-scores. Furthermore, they were asked about any adverse effects during intervention period. Mean differences of VAS pain, total WOMAC, and WOMAC physical function scores in green tea group showed a significant reduction, compared with the control group (P = 0.038, P = 0.006, and P = 0.004, respectively). However, No significant differences between the two groups were observed, regarding mean differences of WOMAC pain and stiffness scores of the enrolled patients (P = 0.163, and P = 0.150, respectively). Additionally, only 1 patient reported gastric upset [in control group]. It seems that green tea extract might well be considered as an adjunctive treatment both for control of pain and for the betterment of knee joint physical function in adults with osteoarthritis. However, further studies of longer duration and larger sample size are needed. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  14. Redefining face contour with a novel anti-aging cosmetic product: an open-label, prospective clinical study.

    Science.gov (United States)

    Garre, Aurora; Martinez-Masana, Gemma; Piquero-Casals, Jaime; Granger, Corinne

    2017-01-01

    Skin aging is accelerated by multiple extrinsic factors: ultraviolet radiation, smoking and pollution increase oxidative activity, damaging cellular and extracellular components such as DNA, proteins, and lipids. With age, collagen and hyaluronic acid levels decline, resulting in loss of elasticity and moisture of the skin. Over time this damage leads to characteristic signs that make the skin look older: altered facial contour, sagging skin, wrinkles, and an uneven complexion. This study evaluated the anti-aging effects of a new facial cream formulated with carnosine, Alteromonas ferment extract, crosspolymer hyaluronic acid, and a tripeptide. An open-label intra-individual study to assess the anti-aging efficacy of the investigational product in 33 women aged 45 to 65 years. The product was applied twice daily for 56 days. Facial contour and skin deformation, elasticity, hydration, and complexion were measured with specialized equipment at baseline and days 28 and 56. Additionally, subjects completed questionnaires at days 28 and 56 on the perceived efficacy and cosmetic characteristics of the product. After 56 days of use of the investigational product, a redefining effect was observed, with a significant decrease in sagging jawline (7%). Skin was significantly more hydrated (12%), firmer (29%), and more elastic (20%) ( P <0.001 for all). On complexion assessment, skin texture (a measure of skin smoothness) and spots (brown and red skin lesions) also improved significantly (12% and 6% decrease, respectively). In the subjective self-evaluation, the majority of subjects reported that the skin was visibly tightened and more elastic, flexible, and moisturized (91%, 88%, 91%, and 90%, respectively). The product was well tolerated with no adverse events reported during the study. This new cosmetic product demonstrated anti-aging effects after 56 days of use, most notably a redefined facial contour and improved complexion. It is a safe and effective anti-aging product.

  15. A single dose, randomized, open-label, cross-over bioequivalence study of sildenafil citrate tablets in healthy Chinese volunteers
.

    Science.gov (United States)

    Li, Dai; Wang, Yu-Lu; Xu, Su-Mei; Li, Dan; Li, Xiao-Min; Pan, Jing; Xu, Ping-Sheng

    2017-02-01

    The present study was designed to evaluate the bioequivalence of a newly developed sildenafil citrate tablet 50 mg (Jinge®, Test) and a marketed counterpart (Viagra®, 100 mg, Reference) in healthy adult male Chinese volunteers. This single-dose, randomized, open-label, four-period, and two-treatment self-crossover study included two parts: fasting and postprandial studies. In each part of the study, the subjects were randomly assigned to receive test or reference products (100 mg sildenafil) in a 1 : 1 ratio, and then received the alternative products, following a 1-week washout period. Plasma sildenafil concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Tolerability was assessed during the entire study period. 32 healthy volunteers (aged 19 - 30) were enrolled in the study; 31 volunteers completed the fasting study, while 32 volunteers completed the postprandial study. The test formulation was bioequivalent to the marketed formulation as the 90% CIs for the ratio of geometric means of Cmax (fasting: 98.79 - 119.61%; fed: 94.47 - 119.65%), AUClast (fasting: 98.70 - 109.71%; fed: 96.39 - 112.89%), and AUC∞ (fasting: 98.45 - 108.87%; fed: 96.36 - 112.74%) were within equivalence limits (80 - 125%) under both fasting and postprandial conditions. When sildenafil was given with high-fat meals, mean Cmax was reduced by 23%, and median tmax ranged from 0.75 to 1.50 hours (p ≤ 0.05). However, both AUClast and AUC∞ were comparable between fasting and postprandial conditions. No serious adverse events were found among the subjects. This study confirmed that test and reference sildenafil citrate tablets were bioequivalent under fasting and postprandial conditions.
.

  16. Maternal vitamin D supplementation during pregnancy prevents vitamin D deficiency in the newborn: an open-label randomized controlled trial.

    Science.gov (United States)

    Rodda, C P; Benson, J E; Vincent, A J; Whitehead, C L; Polykov, A; Vollenhoven, B

    2015-09-01

    To determine whether maternal vitamin D supplementation, in the vitamin D deficient mother, prevents neonatal vitamin D deficiency. Open-label randomized controlled trial. Metropolitan Melbourne, Australia, tertiary hospital routine antenatal outpatient clinic. Seventy-eight women with singleton pregnancies with vitamin D deficiency/insufficiency (serum 25-OH Vit D l) at their first antenatal appointment at 12-16-week gestation were recruited. Participants were randomized to vitamin D supplementation (2000-4000 IU cholecalciferol) orally daily until delivery or no supplementation. The primary outcome was neonatal serum 25-OH vit D concentration at delivery. The secondary outcome was maternal serum 25-OH vit D concentration at delivery. Baseline mean maternal serum 25-OH vit D concentrations were similar (P = 0·9) between treatment (32 nmol/l, 95% confidence interval 26-39 nmol/l) and control groups (33 nmol/l, 95% CI 26-39 nmol/l). Umbilical cord serum 25-OH vit D concentrations at delivery were higher (P l, 95% CI; 70-91 nmol/l) compared with neonates of control group mothers (42 nmol/l, 95% CI; 34-50 nmol/l) with a strongly positive correlation between maternal serum 25-OH Vit D and umbilical cord ser