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

    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.

  2. 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.

  3. Agomelatine versus Sertraline: An Observational, Open-labeled and 12 Weeks Follow-up Study on Efficacy and Tolerability

    Science.gov (United States)

    Akpınar, Esma; Cerit, Cem; Talas, Anıl; Tural, Ümit

    2016-01-01

    Objective In this open-labeled, 12 weeks follow-up study, we aimed to compare the efficacy and tolerability of agomelatine with sertraline Methods The outpatients of adult psychiatry clinic who have a new onset of depression and diagnosed as ‘major depressive episode’ by clinician according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition and prescribed agomelatine (25 mg/day) or sertraline (50 mg/day) were included in the study. Results The decline of mean Montgomery-Asberg Depression Rating Scale (MADRS) scores of agomelatine group was significantly higher than the sertraline group at the end of 2nd week; however, the difference was not significant at the end of 3 months. Mean Clinical Global Impression-Improvement scale (CGI-I) scores of agomelatine group was lower than sertraline group at first week. Mean CGI-Severity scale and CGI-I scores were favour to sertraline group at the end of the study. Remission rates were 46.7% for sertraline group and 33.3% for agomelatine group while response rates were 76.7% for both groups. Any patient from agomelatine group dropped-out due to adverse effects. The amount of side effects was also less with agomelatine. Conclusion Agomelatine has a rapid onset efficacy on depressive symptoms and this can be beneficial for some critical cases. Considering MADRS scores, agomelatine seems to have similar efficacy with sertraline but we also point the need for long term studies since CGI scores were favour to sertraline group at the end of the study. Agomelatine has a favourable tolerability profile both in terms of discontinuation and the amount of side effects compared to sertraline. PMID:27776387

  4. An open label follow-up study on amisulpride in the add-on treatment of bipolar I patients

    Directory of Open Access Journals (Sweden)

    Hardoy Maria

    2006-08-01

    Full Text Available Abstract Background Atypical antipsychotics are widely used in the treatment of bipolar disorders. Amisulpride is an atypical antipsychotic that has been proven to be effective in treatment of schizophrenia, major depressive disorder and, more recently, acute mania. At the moment, however, no study has assessed the effectiveness of this compound in maintenance therapy of bipolar disorders. The purpose of this study was to assess the long-term effectiveness of amisulpride in combination with standard treatments in patients with bipolar I disorder who have shown inadequate responses to ongoing standard therapies. Methods The study enrolled fourteen bipolar I outpatients, not responding to ongoing standard therapy. Three patients discontinued treatment but 11 were followed-up for 11.7 ± 8.2 months before (range 3–24 months and 5.2 ± 2.7 months after the introduction of amisulpride (range 3–9 months. Relapse rates before and during treatment with amisulpride were calculated in accordance to an increase of 1 or more in Clinical Global Impressions Scale-Bipolar Version (CGI-BP score that was accompanied by a change in therapy or to an exacerbation of the symptoms that required hospitalization. Results A statistically significant decrease in overall relapse rate was observed during the period of amisulpride therapy compared with months previous to the introduction of amisulpride. The relative risk of relapse in the absence of amisulpride therapy was 3.1 (χ2 = 4.2, P Discussion and conclusion This open-label study suggests that long-term therapy with amisulpride may benefit patients by improving global symptoms of bipolar disorder and reducing the rate of manic/mixed relapses. Large, randomized, double-blind, placebo-controlled studies are needed to explore the benefits of adding long-term amisulpride to standard therapies for bipolar disorder.

  5. Micronutrients supplementation and nutritional status in cognitively impaired elderly persons: a two-month open label pilot study.

    Science.gov (United States)

    von Arnim, Christine A F; Dismar, Stephanie; Ott-Renzer, Cornelia S; Noeth, Nathalie; Ludolph, Albert C; Biesalski, Hans K

    2013-11-15

    Malnutrition is a widespread problem in elderly people and is associated with cognitive decline. However, interventional studies have produced ambiguous results. For this reason, we wanted to determine the effect of micronutrient supplementation on blood and tissue levels and on general nutritional status in persons with mild or moderate cognitive impairment. We performed a 2-month, open-label trial, administering a daily micronutrient supplement to 42 memory clinic patients with mild cognitive deficits. Blood levels of antioxidants, zinc, and B vitamins were determined before and after supplementation. In addition, we assessed metabolic markers for B vitamins and intracellular (buccal mucosa cell [BMC]) antioxidant levels. Nutritional status was assessed by using the Mini Nutritional Assessment (MNA). Blood levels of B vitamins, folic acid, lutein, β-carotene, α-carotene, and α-tocopherol increased significantly. Decreases in homocysteine levels and the thiamine pyrophosphate effect and an increase in holotranscobalamin were observed. We found no increase in intracellular antioxidant levels of BMC. The MNA score in subjects at risk for malnutrition increased significantly, mainly owing to better perception of nutritional and overall health status. Micronutrient supplementation improved serum micronutrient status, with improved metabolic markers for B vitamins but not for intracellular antioxidant status, and was associated with improved self-perception of general health status. Our data underline the necessity of determining micronutrient status and support the use of additional assessments for general health and quality of life in nutritional supplementation trials.

  6. Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6: results of open-label, two-month, follow-up study

    Directory of Open Access Journals (Sweden)

    Jirathitikal Vichai

    2010-02-01

    Full Text Available Abstract Background Chronic inflammations, atherosclerosis and obesity, are major risk factors for cardiovascular diseases. Immune modulation of the inflammatory response has shown promise in animal models of atherogenesis and metabolic disease. Tableted dietary supplement, V-6, containing pooled antigens derived from pig adipose tissue has been administered daily to 12 volunteers for 2 months. Results No significant changes were observed in liver ALT and AST enzymes, i.e., 28 vs 23.8 IU and 22.6 vs 24.8 IU, with p = 0.07 and p = 0.49, respectively. Creatinine decreased; 0.88 vs 0.84 mg/dL (p = 0.05 while BUN moved upward; 14.5 vs 17.5 mg/dL (p = 0.01, but both values remained within normal range. Blood glucose remained within normal range; 96.1 vs 101.1 mg/dL (p = 0.04. Complete blood cell analysis has not revealed any change except slight increase in hemoglobin; 13.13 to 13.96 g/dL (p = 0.0002; hematocrit and red blood cells count 40.3 to 42.3% (p = 0.02 and 5.15 to 5.35 × 106 cells/mm3 (p = 0.03 respectively. Blood pressure systolic and diastolic values were not affected, i.e., 116.1 vs 116.3 (p = 0.12 and 76.8 vs 76.6 (p = 0.99. Body weight and body mass index (BMI remained same; 66.4 vs 66.3 kg (p = 0.47 and 25.7 vs 25.6 kg/m2 (p = 0.2. Body fat deposit indices, such as abdomen; mid-arm; and thigh circumferences declined by 3.5 cm (p = 0.008; 1.2 cm (p = 0.004; and 3.0 cm (p = 0.0007 respectively. The total cholesterol and LDL levels did not change; 195.5 vs 195.1 (-0.2%; p = 0.8 and 113.4 vs 120.3 (6.1%; p = 0.08 respectively. Triglycerides have been reduced but not statistically significant; 168.1 vs 118 mg/dL (-29.8%; p = 0.2. In contrast, HDL content had risen by 29.7% from 39.4 to 51.1 mg/dL in all 12 patients (p = 0.000003. TG/HDL ratio - a marker of insulin resistance - was reduced from 4.78 to 2.56 (-46.5%; p = 0.04. Conclusions These results demonstrate that V-6 is safe and has a potential as an anti-atherogenic and overweight/obesity immune intervention.

  7. 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

  8. Safety and efficacy of thrombectomy in acute ischaemic stroke (REVASCAT): 1-year follow-up of a randomised open-label trial.

    Science.gov (United States)

    Dávalos, Antoni; Cobo, Erik; Molina, Carlos A; Chamorro, Angel; de Miquel, M Angeles; Román, Luis San; Serena, Joaquín; López-Cancio, Elena; Ribó, Marc; Millán, Mónica; Urra, Xabier; Cardona, Pere; Tomasello, Alejandro; Castaño, Carlos; Blasco, Jordi; Aja, Lucía; Rubiera, Marta; Gomis, Meritxell; Renú, Arturo; Lara, Blanca; Martí-Fàbregas, Joan; Jankowitz, Brian; Cerdà, Neus; Jovin, Tudor G

    2017-05-01

    The REVASCAT trial and other studies have shown that the neurovascular thrombectomy improves outcomes at 90 days post stroke. However, whether the observed benefit is sustained in the long term remains unknown. We report the results of the prespecified 12-month analysis of the REVASCAT trial. Patients with acute ischaemic stroke who could be treated within 8 h of symptom onset were randomly assigned to medical therapy (including intravenous alteplase when eligible) and neurovascular thrombectomy with Solitaire FR or medical therapy alone. The main secondary outcome measure at 1 year follow-up was disability, measured using the modified Rankin Scale (mRS), ranging from 0 (no symptoms) to 6 (death) with categories 5 (severe disability) and 6 (death) collapsed into one category (severe disability or death), analysed as the distribution of the mRS. Additional prespecified secondary outcome measures included health-related quality of life measured with the EuroQol five dimensions questionnaire (EQ-5D) utility index (ranging from -0·3 to 1, higher values indicate better quality of life), the rate of functional independence (mRS 0-2), and cognitive function measured with the Trail Making Test (reported elsewhere). Treatment allocation was open label but endpoints at 12 months were assessed by masked investigators. The trial was registered at ClinicalTrials.gov, number NCT01692379. From Nov 24, 2012, to Dec 12, 2014, 206 patients were randomly assigned to medical therapy plus endovascular treatment (n=103) or medical treatment alone (n=103), at four centres in Catalonia, Spain. At 12 months post randomisation, based on 205 of 206 outcomes available at 12 months, thrombectomy reduced disability over the range of the mRS (common adjusted odds ratio [aOR] 1·80, 95% CI 1·09-2·99), and improved functional independence (mRS=0-2; 45 [44%] of 103 patients vs 31 [30%] of 103 patients; aOR 1·86, 95% CI 1·01-3·44). Health-related quality of life was superior in the

  9. 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....

  10. Deep brain stimulation of the subcallosal cingulate for treatment-refractory anorexia nervosa: 1 year follow-up of an open-label trial.

    Science.gov (United States)

    Lipsman, Nir; Lam, Eileen; Volpini, Matthew; Sutandar, Kalam; Twose, Richelle; Giacobbe, Peter; Sodums, Devin J; Smith, Gwenn S; Woodside, D Blake; Lozano, Andres M

    2017-04-01

    Anorexia nervosa is a life-threatening illness. Brain circuits believed to drive anorexia nervosa symptoms can be accessed with surgical techniques such as deep brain stimulation (DBS). Initial results suggest that DBS of the subcallosal cingulate is safe and associated with improvements in mood and anxiety. Here, we investigated the safety, clinical, and neuroimaging outcomes of DBS of the subcallosal cingulate in a group of patients during 12 months of active stimulation. We did this prospective open-label trial at the Department of Surgery of the University of Toronto (Toronto, ON, Canada). Patients were eligible to participate if they were aged 20-60 years and had a diagnosis of anorexia nervosa (restricting or binge-purging subtype) and a demonstrated history of chronicity or treatment resistance. Following a period of medical stabilisation, patients underwent surgery for DBS and received open-label continuous stimulation for the entire 1 year study duration. The primary outcome was safety and acceptability of the procedure. The secondary outcomes were body-mass index (BMI), mood, anxiety, affective regulation, and anorexia nervosa-specific behaviours at 12 months after surgery, as well as changes in neural circuitry (measured with PET imaging of cerebral glucose metabolism at baseline and at 6 and 12 months after surgery). This trial was registered with ClinicalTrials.gov, number NCT01476540. 16 patients with treatment-refractory anorexia nervosa were enrolled between September, 2011, and January, 2014, and underwent DBS of the subcallosal cingulate between November, 2011, and April, 2014. Patients had a mean age of 34 years (SD 8) and average illness duration of 18 years (SD 6). Two patients requested that their devices be removed or deactivated during the study, although their reasons for doing so were poorly defined. The most common adverse event was pain related to surgical incision or positioning that required oral analgesics for longer than 3-4 days

  11. Improvement of executive functions in boys with attention deficit hyperactivity disorder: an open-label follow-up study with once-daily atomoxetine.

    Science.gov (United States)

    Gau, Susan Shur-Fen; Shang, Chi-Yung

    2010-03-01

    Atomoxetine is efficacious in reducing symptoms of attention deficit hyperactivity disorder (ADHD) but its effect on executive functions needs more investigation. We examined the effect of atomoxetine on a wide range of non-verbal executive functions among 30 drug-naive male patients with DSM-IV ADHD, aged 8-16 yr, in an open-label 12-wk atomoxetine treatment trial. Before administration of atomoxetine, the participants were assessed by psychiatric interviews, the WISC-III, and the tasks involving executive functions of the Cambridge Neuropsychological Test Automated Battery (CANTAB): Intra-dimensional/Extra-dimensional Shifts (IED), Rapid Visual Information Processing (RVIP), Spatial Span (SSP), Spatial Working Memory (SWM), and Stockings of Cambridge (SOC); and reassessed at weeks 4 and 12. All the raw scores of the CANTAB were transformed to z scores based on a normative sample of 180 children aged 8-16 yr. Results showed significant improvement in executive functions after treatment with atomoxetine for 4 wk or 12 wk including improved shifting and flexibility of attention in the IED; improved spatial short-term memory in the SSP; improved sustained attention and increased response inhibition in the RVIP; improved spatial working memory in the SWM; and improved spatial planning and problem solving in the SOC. Our findings suggested that atomoxetine was associated with significant improvement in various non-verbal executive functions among boys with ADHD, in addition to its well-known efficacy in ADHD-related symptom reductions. However, owing to lack of a placebo-controlled trial design, the findings should be interpreted with caution that changes in performance may be due to practice effects.

  12. Effect of palmitoylethanolamide on visual field damage progression in normal tension glaucoma patients: results of an open-label six-month follow-up.

    Science.gov (United States)

    Costagliola, Ciro; Romano, Mario R; dell'Omo, Roberto; Russo, Andrea; Mastropasqua, Rodolfo; Semeraro, Francesco

    2014-09-01

    The purpose of this study is to assess the effect of palmitoylethanolamide (PEA) oral administration on intraocular pressure (IOP) and visual field damage progression in normal-tension glaucoma (NTG) patients. Thirty-two consecutive patients affected by NTG were enrolled and randomized in a 1:1 ratio to receive PEA treatment (group A) or no treatment (group B). Group A patients took ultramicronized 300 mg PEA tablets two times per day for six months. Best-corrected visual acuity (BCVA), IOP, and visual field test were evaluated at baseline and at the end of the six-month follow-up. No significant differences in clinical parameters between the two groups were observed at baseline. At six months, group A patients showed significant IOP reduction (from 14.4±3.2 mm Hg to 11.1±4.3 mm Hg, pVisual field parameters significantly diminished in patients receiving PEA compared to baseline values (-7.65±6.55 dB vs. -4.55±5.31 dB, pvisual field indices in individuals affected by NTG. Neither ocular nor systemic side effects were recorded during the study period.

  13. 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

    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 (inattention subscales of the so-called Fremdbeurteilungsbogen für Hyperkinetische Störungen and Child Behavior Checklist/4–18 [CBCL/4–18]). All data were analyzed retrospectively. Results 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). Conclusion 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

  14. 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...

  15. 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.

  16. Hyper Cold Systems follow up

    Science.gov (United States)

    Berges, Jean Claude; Beltrando, Gerard; Cacault, Philippe

    2016-04-01

    The follow up of intense precipitation system is a key information for climate studies. Whereas some rainfall measurement series cover more than one century they cannot retrieve these phenomena in their spatial and temporal continuity. The geostationary satellite data offer a good trade-off between the length of data series and the retrieval accuracy. However a difficulty arise from ambiguous interpretation of the lone infrared signal in nephanalysis. Hence the tropopause temperature is used as a proxy to characterize extreme precipitation event. That does not mean that the more intense rain-rate will be always collocated with the coldest temperature but that most of these intense events is produced by systems whose a part is colder than tropopause. Computations have been carried out on 38 months of MSG and Meteosat/IODC. System follow up is achieved by a simple 3D connexity algorithm, the time being considered as the third dimension. This algorithm produce three dimension clusters from where the main system parameters can be easily extracted. Thus the systems can be classified trajectory characteristic (duration, speed ans size variation). A drawback of this simple threshold method relies is some over-segmentation. In most of case the bias is minor as unconnected clusters are small and short-lived. However an aggregating algorithm have been developed to retrieve the most complex system trajectories. To assess the efficiency of this method three regional studies are displayed: the North African Maghreb, the West African Sahel and the Indian Ocean. On Maghreb, the location of system initialization shows a dramatic difference between the eastern and western parts. Whereas in Tunisia a significant part of these systems are generated on sea and most have no clear relation with relief, the Morocco is mainly characterized with land initiated system with a strong orographic effect on system triggering. Another difference relies on the low level wind shear impact which

  17. Open-Label Memantine in Fragile X Syndrome

    Science.gov (United States)

    Erickson, Craig A.; Mullett, Jennifer E.; McDougle, Christopher J.

    2009-01-01

    Glutamatergic dysfunction is implicated in the pathophysiology of fragile X syndrome (FXS). The purpose of this pilot study was to examine the effectiveness and tolerability of memantine for a number of target symptoms associated with FXS. Medical records describing open-label treatment with memantine in 6 patients with FXS and a comorbid…

  18. 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...... that have been selected for follow-up. A preliminary estimate indicates that between 24% and 62% of planetary candidates selected for follow-up will turn out to be true planets....

  19. Oral zinc sulfate treatment for viral warts: an open-label study.

    Science.gov (United States)

    Mun, Je-Ho; Kim, Su-Han; Jung, Do-Sang; Ko, Hyun-Chang; Kim, Byung-Soo; Kwon, Kyung-Sool; Kim, Moon-Bum

    2011-06-01

    Viral warts, which are caused by the human papilloma virus, are a common problem in dermatology. Various modalities have been used to treat warts, but none are uniformly effective or directly antiviral. Recent studies show that oral zinc sulfate could be effective in the treatment of viral warts. Thirty-one patients with multiple, non-genital viral warts were recruited in this open-label clinical study. The patients were treated with oral zinc sulfate (10 mg/kg to a maximum dose of 600 mg/day) for 2 months and followed up with assessments for the resolution of their warts and for any evidence of recurrence after treatment. Among the 31 patients, 18 patients showed low serum zinc levels (58%). Of 26 patients who completed the study (84%), 13 (50%) showed complete resolution of their warts after 2 months of treatment. Complete responders remained free of lesions at 6-month follow-up. No serious side-effects were reported apart from nausea (16%), mild gastric pain (3%) and itching sensation (3%). Oral zinc sulfate was found to be a good option in the treatment of viral warts, as it was safe and effective without important side-effects. © 2010 Japanese Dermatological Association.

  20. 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.

  1. Follow-up utterances in QA dialogue

    NARCIS (Netherlands)

    Schooten, van Boris; Akker, op den Rieks

    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

  2. Follow-up in Childhood Functional Constipation

    DEFF Research Database (Denmark)

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

    2015-01-01

    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...

  3. 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

    2016-01-01

    Abstract 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 < 0.001), with moderate to large effect sizes. 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 < 0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (−1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both 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. PMID:27755279

  4. Robotic Follow-Up for Human Exploration

    Science.gov (United States)

    Fong, Terrence; Bualat, Maria; Deans, Matthew C.; Adams, Byron; Allan, Mark; Altobelli, Martha; Bouyssounouse, Xavier; Cohen, Tamar; Flueckiger, Lorenzo; Garber, Joshua; Palmer, Elizabeth; Heggy, Essam; Jurgens, Frank; Kennedy, Tim; Kobayashi, Linda; Lee, Pascal; Lee, Susan Y.; Lees, David; Lundy, Mike; Park, Eric; Pedersen, Liam; Smith, Trey; To, Vinh; Utz, Hans; Wheeler, Dawn

    2010-01-01

    We are studying how "robotic follow-up" can improve future planetary exploration. Robotic follow-up, which we define as augmenting human field work with subsequent robot activity, is a field exploration technique designed to increase human productivity and science return. To better understand the benefits, requirements, limitations and risks associated with this technique, we are conducting analog field tests with human and robot teams at the Haughton Crater impact structure on Devon Island, Canada. In this paper, we discuss the motivation for robotic follow-up, describe the scientific context and system design for our work, and present results and lessons learned from field testing.

  5. 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)...

  6. Nurse-Led Follow-Up at Home vs. Conventional Medical Outpatient Clinic Follow-Up in Patients With Incurable Upper Gastrointestinal Cancer: A Randomized Study

    NARCIS (Netherlands)

    M.J. Uitdehaag (Madeleen); P.G. van Putten (Paul); C.H.J. van Eijck (Casper); E.M.L. Verschuur (Els); A. van der Gaast (Ate); C.J. Pek (Chulja); C.C.D. van der Rijt (Carin); R.A. de Man (Robert); E.W. Steyerberg (Ewout); C. Laheij (Claudia); P.D. Siersema (Peter); M.C.W. Spaander (Manon); E.J. Kuipers (Ernst)

    2013-01-01

    textabstractContext: Upper gastrointestinal cancer is associated with a poor prognosis. The multidimensional problems of incurable patients require close monitoring and frequent support, which cannot sufficiently be provided during conventional one to two month follow-up visits to the outpatient cli

  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. The Community Follow-up Project (CFUP).

    Science.gov (United States)

    Sherina, M S; Azhar, M Z; Mohd Yunus, A; Azlan Hamzah, S A

    2005-08-01

    The Community Follow-up Project (CFUP) is a project where medical students choose a hospital in-ward patient during their clinical ward-based attachments and follow-up this patient's progress after discharge from the hospital. The students do a series of home visits and also accompany their patients for some of their follow-ups at the hospital, government clinics, general practitioners' clinics and even to the palliative care or social welfare centres. The students assess the physical, psychological and social impact of the illness on the patient, family and community. By following their patients from the time their patients were in the hospital and back to their homes and community, the students are able to understand in depth the problems faced by patients, the importance of communication skills in educating patients on their illness and the importance of good communication between primary, secondary and tertiary care.

  9. The Kepler Follow-up Observation Program

    CERN Document Server

    Gautier, Thomas N; Borucki, William J; Cochran, William D; Dunham, Edward W; Howell, Steve B; Koch, David G; Latham, David W; Marcy, Geo? W; Buchhave, Lars A; Ciardi, David R; Endl, Michael; Furesz, Gabor; Isaacson, Howard; MacQueen, Phillip; Mandushev, Georgi; Walkowicz, Lucianne

    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 for identification of astrophysical phenomena that mimic planetary transits and for characterization of the true planets and planetary systems found by Kepler. We have developed techniques and protocols for detection of false planetary transits and are currently conducting observations on 177 Kepler targets that have been selected for follow-up. A preliminary estimate indicates that between 24% and 62% of planetary candidates selected for follow-up will turn out to be true planets.

  10. Follow-up of erlotinib related uveitis

    Science.gov (United States)

    Kumar, Indu; Ali, Kashif; Usman-Saeed, Muniba; Saeed, Muhammad Usman

    2012-01-01

    The authors report the follow-up of a 68-year-old lady with bilateral anterior uveitis secondary to erlotinib. Erlotinib was started and stopped after symptoms and signs suggestive of severe bilateral anterior uveitis were noted. The patient developed signs of a non-ST elevation myocardial infarction, 12 days after stopping the erlotinib, and recovered without major problems. The patient also reported intermittent low-grade fever since starting erlotinib which resolved after stopping this drug. No further symptoms of uveitis were noted up to 6 month follow-up. The patient reported improved well being, resolution of ocular symptoms and intermittent low-grade fever at last follow-up (6 months after stopping erlotinib). PMID:22892235

  11. 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.

  12. Open label trial of granulocyte apheresis suggests therapeutic efficacy in chronically active steroid refractory ulcerative colitis

    Institute of Scientific and Technical Information of China (English)

    Wolfgang Kruis; Robert L(o)fberg; Axel Dignass; Elisabeth Steinhagen-Thiessen; Julia Morgenstern; Joachim M(o)ssner; Stephan Schreiber; Maurizio Vecchi; Alberto Malesci; Max Reinshagen

    2005-01-01

    AIM:To study the efficacy, safety, and feasibility of a granulocyte adsorptive type apheresis system for the treatment of patients with chronically active ulcerative colitis despite standard therapy.METHODS: An open label multicenter study was carried out in 39 patients with active ulcerative colitis (CAI6-8) despite continuous use of steroids (a minimum total dose of 400 mg prednisone within the last 4 wk).Patients received a total of five aphereses using a granulocyte adsorptive technique (Adacolumn(R), Otsuka Pharmaceutical Europe, UK). Assessments at wk 6 and during follow-up until 4 mo comprised clinical (CAI) and endoscopic (EI) activity index, histology, quality of life(IBDQ), and laboratory tests.RESULTS: Thirty-five out of thirty-nine patients were qualified for intent-to-treat analysis. After the apheresis treatment at wk 6, 13/35 (37.1%) patients achieved clinical remission and 10/35 (28.6%) patients had endoscopic remission (CAI<4, EI<4). Quality of life (IBDQ) increased significantly (24 points, P<0.01)at wk 6. Apheresis could be performed in all but one patient. Aphereses were well tolerated, only one patient experienced anemia.CONCLUSION: In patients with steroid refractory ulcerative colitis, five aphereses with a granulocyte/monocyte depleting filter show potential short-term efficacy. Tolerability and technical feasibility of the procedure are excellent.

  13. 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.

  14. Follow-Up Treatment and Rehabilitation

    Science.gov (United States)

    ... Learn › Stages › In Treatment Follow-Up Treatment and Rehabilitation Originally published on November 10, 2009 Most recently ... will need to be monitored when treatment stops. Rehabilitation Therapist Either the tumor itself or the effects ...

  15. Giant Cholesteatoma : Recommendations for Follow-up

    NARCIS (Netherlands)

    Geven, Leontien I.; Mulder, Jef J. S.; Graamans, Kees

    2008-01-01

    This report presents the management of five patients who presented with giant recurrent or residual cholesteatoma after periods of 2 to 50 years. Their case histories are highly diverse, but all provide evidence of the need for long-term follow-up.

  16. Open-label escitalopram treatment for pathological skin picking.

    Science.gov (United States)

    Keuthen, Nancy J; Jameson, Mariko; Loh, Rebecca; Deckersbach, Thilo; Wilhelm, Sabine; Dougherty, Darin D

    2007-09-01

    Pathological skin picking is characterized by dysfunctional, repetitive and excessive manipulation of the skin resulting in noticeable tissue damage. This study sought to assess the effectiveness of escitalopram in treating pathological skin picking. Twenty-nine individuals with pathological skin picking were enrolled in an 18-week, open-label trial of escitalopram. Study measures assessing skin picking severity and impact, anxiety, depression, and quality of life were given at baseline and weeks 2, 4, 6, 10, 14, and 18. The mean maximally tolerated dose was 25.0 mg (standard deviation=8.4). For the 19 study completers, pre-post-treatment analyses revealed significant improvements (Ppicking severity and impact, quality of life, and self-rated anxiety and depression. Completer as well as intent-to-treat analyses indicated that approximately half of the sample satisfied full medication response criteria and one-quarter were partial medication responders. Correlational analyses indicated that changes in depression, anxiety, and quality of life co-occurred with reductions in skin picking severity but not impact. A high percentage of variance in severity, however, remained unexplained. These results suggest that escitalopram can be an effective agent in reducing pathological skin picking. The lack of medication response in a subset of our sample suggests the possibility of pathological skin picking subtypes.

  17. The LCOGT NEO Follow-up Network

    Science.gov (United States)

    Lister, Tim; Greenstreet, Sarah; Gomez, Edward; Christensen, Eric J.; Larson, Stephen M.

    2016-10-01

    The LCOGT NEO Follow-up Network is using the telescopes of the Las Cumbres Observatory Global Telescope Network (LCOGT) and a web-based target selection, scheduling and data reduction system to confirm NEO candidates and characterize radar-targeted known NEOs. Starting in July 2014, the LCOGT NEO Follow-up Network has observed over 3,500 targets and reported more than 16,000 astrometric and photometric measurements to the Minor Planet Center (MPC).The LCOGT NEO Follow-up Network's main aims are to perform confirming follow-up of the large number of NEO candidates and to perform characterization measurements of radar targets to obtain light curves and rotation rates. The NEO candidates come from the NEO surveys such as Catalina, PanSTARRS, ATLAS, NEOWISE and others. In particular, we are targeting objects in the Southern Hemisphere, where the LCOGT NEO Follow-up Network is the largest resource for NEO observations.LCOGT has completed the first phase of the deployment with the installation and commissioning of the nine 1-meter telescopes at McDonald Observatory (Texas), Cerro Tololo (Chile), SAAO (South Africa) and Siding Spring Observatory (Australia). The telescope network has been fully operational since 2014 May, and observations are being executed remotely and robotically. Future expansion to a site at Ali Observatory, Tibet is planned for 2017-2018.We have developed web-based software called NEOexchange which automatically downloads and aggregates NEO candidates from the Minor Planet Center's NEO Confirmation Page, the Arecibo and Goldstone radar target lists and the NASA ARM list. NEOexchange allows the planning and scheduling of observations on the LCOGT Telescope Network and the tracking of the resulting blocks and generated data. We have recently extended the NEOexchange software to include automated data reduction to re-compute the astrometric solution, determine the photometric zeropoint and find moving objects and present these results to the user via

  18. Intravenous Immunoglobulin Therapy in Pediatric Narcolepsy: A Nonrandomized, Open-Label, Controlled, Longitudinal Observational Study

    Science.gov (United States)

    Lecendreux, Michel; Berthier, Johanna; Corny, Jennifer; Bourdon, Olivier; Dossier, Claire; Delclaux, Christophe

    2017-01-01

    Study Objectives: Previous case reports of intravenous immunoglobulins (IVIg) in pediatric narcolepsy have shown contradictory results. Methods: This was a nonrandomized, open-label, controlled, longitudinal observational study of IVIg use in pediatric narcolepsy with retrospective data collection from medical files obtained from a single pediatric national reference center for the treatment of narcolepsy in France. Of 56 consecutively referred patients with narcolepsy, 24 received IVIg (3 infusions administered at 1-mo intervals) in addition to standard care (psychostimulants and/or anticataplectic agents), and 32 continued on standard care alone (controls). Results: For two patients in each group, medical files were unavailable. Of the 22 IVIg patients, all had cerebrospinal fluid (CSF) hypocretin ≤ 110 pg/mL and were HLA-DQB1*06:02 positive. Of the 30 control patients, 29 were HLA-DQB1*06:02 positive and of those with available CSF measurements, all 12 had hypocretin ≤ 110 pg/mL. Compared with control patients, IVIg patients had shorter disease duration, shorter latency to sleep onset, and more had received H1N1 vaccination. Mean (standard deviation) follow-up length was 2.4 (1.1) y in the IVIg group and 3.9 (1.7) y in controls. In multivariate-adjusted linear mixed-effects analyses of change from baseline in Ullanlinna Narcolepsy Scale (UNS) scores, high baseline UNS, but not IVIg treatment, was associated with a reduction in narcolepsy symptoms. On time-to-event analysis, among patients with high baseline UNS scores, control patients achieved a UNS score narcolepsy symptoms were not significantly reduced by IVIg. However, in patients with high baseline symptoms, a subset of IVIg-treated patients achieved remission more rapidly than control patients. Commentary: A commentary on this article appears in this issue on page 363. Citation: Lecendreux M, Berthier J, Corny J, Bourdon O, Dossier C, Delclaux C. Intravenous immunoglobulin therapy in pediatric

  19. A FOLLOW UP STUDY OF HYSTERIA1

    Science.gov (United States)

    Wig, N.N.; Mangalwedhe, K.; Bedi, Harminder; Murthy, R. Srinivas

    1982-01-01

    SUMMARY The present study undertook to examine the outcome of a group of cases who were diagnosed as hysteria, six or more years ago in a general hospital psychiatric unit and correlate various clinical factors with good or bad outcome. Of the 81 cases selected for the study, 57 (67%) could be located and followed up after a gap of 6-8 years. Majority of the cases (74%) had either no symptoms or symptoms less than before at the time of the follow up. In only 3 cases, there was evidence of an underlying organic illness which seemed to have been missed at the initial assessment. A new sub-classification of hysteria with glossary of terms used for this study is presented for future research work. PMID:21965899

  20. Radiological follow-up of inverted papilloma

    Energy Technology Data Exchange (ETDEWEB)

    Petit, P.; Vivarrat-Perrin, L.; Champsaur, P.; Juhan, V.; Chagnaud, C.; Vidal, V.; Gaubert, J.Y.; Bartoli, J.M.; Moulin, G. [Department of Radiology, Groupe Hospitalier de la Timone, Centre Hospitalier et Universitaire de Marseille, F-13385 Marseille Cedex 5 (France); Dessi, P.; Zanaret, M. [Department of Head and Neck Surgery, Groupe Hospitalier de la Timone, Centre Hospitalier et Universitaire de Marseille, F-13385 Marseille Cedex 5 (France)

    2000-07-01

    The aim of this study was to describe cross-sectional imaging features of recurrent papilloma of the nasal fossa and paranasal sinuses and to evaluate the role of MR and CT in the postoperative follow-up of this lesion. Magnetic resonance imaging and CT of ten patients who presented recurrence of inverted papilloma were reviewed and correlated to initial imaging, endoscopy, and surgical reports. Imaging patterns of recurrent inverted papilloma are identical to those of initial tumors and recurrence location is closely related to the site of the former lesion. Magnetic resonance is more efficient than CT for the diagnosis and evaluation of extensions. Magnetic resonance supplies the deficiencies of endoscopy in case of extensions to the frontal sinus or the lateral recess of the antrum, especially if mucosal hyperplasia or sinusitis is associated. Magnetic resonance imaging is the first imaging modality to perform in the follow-up after removal of inverted papilloma. (orig.)

  1. 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...... 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...... high-resolution spectrometers on the Lick 3.0-m Shane Telescope, the McDonald 2.7-m Reflector, the 2.5-m Nordic Optical Telescope, and the 1.5-m Tillinghast Reflector at the Whipple observatory. In this paper we will summarize the scope and organization of the spectroscopic follow-up observations...

  2. Radiologic findings and follow-up evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Young Tong; Kim, Cheol Hyun; Kim, Hyung Hwan; Shin, Hyeong Cheol; Bae, Won Kyung; Kim, Il Young [Soonchunhyang University, Chonan (Korea, Republic of)

    2003-07-01

    In esophageal perforation, fistulous tracts commonly occur between the esophagus and mediastinal or pleural spaces, but rarely between the esophagus and bronchi. The clinical manifestations and radiologic findings of esophageal perforation are nonspecfic, and diagnosis is the often delayed; esophagography is the standard technique for evaluation of its location and degree. CT is useful in demonstrating the extraluminal manifestations of esophageal perforation and for follow-up after medical treatment, and may depict the various manifestations of perforation, according to the causes.

  3. Prompt GRB optical follow-up experiments

    Energy Technology Data Exchange (ETDEWEB)

    Park, H-S; Williams, G; Ables, E; Band, D; Barthelmy, S; Bionta, R; Cline, T; Gehrels, N; Hartmann, D; Hurley, K; Kippen, M; Nemiroff, R; Pereira, W; Porrata, R

    2000-11-13

    Gamma Ray Bursts (GRBs) are brief, randomly located, releases of gamma-ray energy from unknown celestial sources that occur almost daily. The study of GRBs has undergone a revolution in the past three years due to an international effort of follow-up observations of coordinates provided by Beppo/SAX and IPN GRB. These follow-up observations have shown that GRBs are at cosmological distances and interact with surrounding material as described by the fireball model. However, prompt optical counterparts have only been seen in one case and are therefore very rare or much dimmer than the sensitivity of the current instruments. Unlike later time afterglows, prompt optical measurements would provide information on the GRB progenitor. LOTIS is the very first automated and dedicated telescope system that actively utilizes the GRB Coordinates Network (GCN) and it attempts to measure simultaneous optical light curve associated with GRBs. After 3 years of running, LOTIS has responded to 75 GRB triggers. The lack of any optical signal in any of the LOTIS images places numerical limits on the surrounding matter density, and other physical parameters in the environment of the GRB progenitor. This paper presents LOTIS results and describes other prompt GRB follow-up experiments including the Super-LOTIS at Kitt Peak in Arizona.

  4. Effect of high-dose phenobarbital on oxidative stress in perinatal asphyxia: an open label randomized controlled trial.

    Science.gov (United States)

    Gathwala, Geeta; Marwah, Ashish; Gahlaut, Veena; Marwah, Poonam

    2011-08-01

    To evaluate the effect of high dose phenobarbital on lipid peroxidation and antioxidant enzymes in perinatal asphyxia. Open label, Randomized controlled trial. Neonatal intensive care unit of a tertiary care teaching hospital. 72 full term inborn neonates with severe birth asphyxia. Neonates were randomized to Study (phenobarbital) group and Control group. The infants in the study group received phenobarbital infusion (40 mg/kg) within first two hours of life while babies in the control group did not receive any phenobarbital. Rest of the management in both the groups was as per the unit protocol for the management of hypoxic ischemic encephalopathy. A cerebrospinal fluid examination was done at 12 ± 2 hours of life to determine the levels of superoxide dismutase, glutathione peroxidise and malonyldialdehyde. 60 neonates were followed up at 1 month of age when a detailed neurological examination was done. Four neonates in the study group and six neonates in the control group died during the study. Two neonates in the study group were lost to follow up. The cerebrospinal fluid lipid peroxides and antioxidant enzymes were significantly lower in the phenobarbital group as compared to the control group. The neurological outcome at one month follow up was found to be comparable between the two groups. Phenobarbital (40 mg/kg) given in the first two hours of life in term neonates with perinatal asphyxia led to a decrease in CSF levels of lipid peroxides and antioxidant enzymes at 12 ± 2 hours of life.

  5. Disk Detective Follow-Up Program

    Science.gov (United States)

    Kuchner, Marc

    As new data on exoplanets and young stellar associations arrive, we will want to know: which of these planetary systems and young stars have circumstellar disks? The vast allsky database of 747 million infrared sources from NASA's Wide-field Infrared Survey Explorer (WISE) mission can supply answers. WISE is a discovery tool intended to find targets for JWST, sensitive enough to detect circumstellar disks as far away as 3000 light years. The vast WISE archive already serves us as a roadmap to guide exoplanet searches, provide information on disk properties as new planets are discovered, and teach us about the many hotly debated connections between disks and exoplanets. However, because of the challenges of utilizing the WISE data, this resource remains underutilized as a tool for disk and planet hunters. Attempts to use WISE to find disks around Kepler planet hosts were nearly scuttled by confusion noise. Moreover, since most of the stars with WISE infrared excesses were too red for Hipparcos photometry, most of the disks sensed by WISE remain obscure, orbiting stars unlisted in the usual star databases. To remedy the confusion noise problem, we have begun a massive project to scour the WISE data archive for new circumstellar disks. The Disk Detective project (Kuchner et al. 2016) engages layperson volunteers to examine images from WISE, NASA's Two Micron All-Sky Survey (2MASS) and optical surveys to search for new circumstellar disk candidates via the citizen science website DiskDetective.org. Fueled by the efforts of > 28,000 citizen scientists, Disk Detective is the largest survey for debris disks with WISE. It has already uncovered 4000 disk candidates worthy of follow-up. However, most host stars of the new Disk Detective disk candidates have no known spectral type or distance, especially those with red colors: K and M stars and Young Stellar Objects. Others require further observations to check for false positives. The Disk Detective project is supported by

  6. The LCOGT NEO Follow-up Network

    Science.gov (United States)

    Lister, Tim; Gomez, Edward; Greenstreet, Sarah

    2015-08-01

    Las Cumbres Observatory Global Telescope Network (LCOGT) has deployed a homogeneous telescope network of nine 1-meter telescopes to four locations in the northern and southern hemispheres, with a planned network of twelve 1-meter telescopes at 6 locations. This network is very versatile and is designed to respond rapidly to target of opportunity events and also to perform long term monitoring of slowly changing astronomical phenomena. The global coverage of the network and the apertures of telescope available make LCOGT ideal for follow-up and characterization of Solar System objects (e.g. asteroids, Kuiper Belt Objects, comets, Near-Earth Objects (NEOs)) and ultimately for the discovery of new objects.LCOGT has completed the first phase of the deployment with the installation and commissioning of the nine 1-meter telescopes at McDonald Observatory (Texas), Cerro Tololo (Chile), SAAO (South Africa) and Siding Spring Observatory (Australia). The telescope network has been fully operational since 2014 May, and observations are being executed remotely and robotically. Future expansion to sites in the Canary Islands and Tibet is planned for 2016.I am using the LCOGT network to confirm newly detected NEO candidates produced by the major sky surveys such as Catalina Sky Survey (CSS) and PanSTARRS (PS1) and several hundred targets are now being followed-up per year. An increasing amount of time is being spent to obtain follow-up astrometry and photometry for radar-targeted objects and those on the Near-Earth Object Human Space Flight Accessible Targets Study (NHATS) or Asteroid Retrieval Mission (ARM) lists in order to improve the orbits, determine the light curves and rotation periods and improve the characterization. This will be extended to obtain more light curves of other NEOs which could be targets. Recent results have included the first period determinations for several of the Goldstone-targeted NEOs. We are in the process of building a NEO Portal which will allow

  7. A follow up study on interstitial alveolitis

    Directory of Open Access Journals (Sweden)

    Kamat S

    2004-01-01

    Full Text Available Objective : To study the benefits of steroid therapy in interstitial alveolitis. Method and Materials : One hundred five adult clinic patients were studied with clinical evaluation, chest radiography, CT scan, bronchoscopic lavage, pulmonary function studies and a regular follow up. They were put on daily prednisolone (in 19 on intravenous methyl prednisolone, for several months. Results: Only a few had no cough or dypnoea; 91 cases had atleast gr. III exertional breathlessness; 61(58% had been given steroids earlier and 32(31% were on a prior antitubercular treatment. Only 16% had GERD symptoms. On radiography, interstitial deposits were seen in 102 cases. While 53 cases belonged to idiopathic variety, 41 were sarcoidosis. A majority had poor lung function with a restrictive disability; but 50% showed a significant response (10%+ to bronchodilators. On follow up in 92 cases, 14 died, 8 went in remission; 32 had a fluctuating course. At some stage 66 had showed improvement. Conclusion : A large majority of our interstitial alveolitis cases are very disabled. They show clinical, functional, and radiographic improvement to long term oral prednisolone. In nonresponsive cases, intravenous steroids show an objective response.

  8. Tocotrienol Treatment in Familial Dysautonomia: Open-Label Pilot Study.

    Science.gov (United States)

    Cheishvili, David; Maayan, Channa; Holzer, Naama; Tsenter, Jeanna; Lax, Elad; Petropoulos, Sophie; Razin, Aharon

    2016-07-01

    Familial dysautonomia (FD) is an autosomal recessive congenital neuropathy, primarily presented in Ashkenazi Jews. The most common mutation in FD patients results from a single base pair substitution of an intronic splice site in the IKBKAP gene which disrupts normal mRNA splicing and leads to tissue-specific reduction of IKBKAP protein (IKAP). To date, treatment of FD patients remains preventative, symptomatic and supportive. Based on previous in vitro evidence that tocotrienols, members of the vitamin E family, upregulate transcription of the IKBKAP gene, we aimed to investigate whether a similar effects was observed in vivo. In the current study, we assessed the effects of tocotrienol treatment on FD patients' symptoms and IKBKAP expression in white blood cells. The initial daily doses of 50 or 100 mg tocotrienol, doubled after 3 months, was administered to 32 FD patients. Twenty-eight FD patients completed the 6-month study. The first 3 months of tocotrienol treatment was associated with a significant increase in IKBKAP expression level in FD patients' blood. Despite doubling the dose after the initial 3 months of treatment, IKBKAP expression level returned to baseline by the end of the 6-month treatment. Clinical improvement was noted in the reported clinical questionnaire (with regard to dizziness, bloching, sweating, number of pneumonia, cough episodes, and walking stability), however, no significant effect was observed in any clinical measurements (weight, height, oxygen saturation, blood pressure, tear production, histamine test, vibration threshold test, nerve conduction, and heart rate variability) following Tocotrienol treatment. In conclusion, tocotrienol treatment appears significantly beneficial by clinical evaluation for some FD patients in a few clinical parameters; however it was not significant by clinical measurements. This open-label study shows the complexity of effect of tocotrienol treatment on FD patients' clinical outcomes and on

  9. Improving pediatric Inflammatory Bowel Disease (IBD) follow-up

    Science.gov (United States)

    Dykes, Dana; Williams, Elizabeth; Margolis, Peter; Ruschman, Jennifer; Bick, Julianne; Saeed, Shehzad; Opipari, Lisa

    2016-01-01

    Standardization of Inflammatory Bowel Disease (IBD) care through participation in the ImproveCareNow (ICN) Network has improved outcomes for pediatric patients with IBD, but under the current care model, our improvements have plateaued. Current ICN model care guidelines recommend health supervision visits every six months. We identified a gap in our practice's ability to ensure either a routine six month follow-up or a rapid follow-up after a disease flare, and a significant number of patients with active disease status during a six month period lacked timely reassessment after interventions or medication changes. Telemedicine provides an alternative method of care delivery to address these gaps, but has had limited use in patients with IBD. A multi-step approach to offer alternative follow-up care options via telemedicine was developed with potential impact on remission rates and quality of life. Short term goals of the pilot were to improve telemedicine access for patients with IBD were to 1) increase the percent of patients with active disease with a follow-up completed within two months of a visit from 40% to 70%, 2) increase the percent of patients with a visit scheduled within two months of their last sick visit from 20% to 70% (interim measure), 3) increase the number of eVisits from zero visits per month to two visits per month during pilot phase, 4) increase electronic communication with patients from zero messages per month to 200 messages per month, 5) no change in complications or adverse events (defined as an unplanned visit or ED (emergency department) encounter within 30 days of an eVisit. The expected outcomes of the e-visit model were to: maintain baseline care standards and health screening capabilities, improve access to care, and provide equivalent care delivery (no increase in the number of unplanned clinical encounters). Using the IHI model for improvement (Plan-Do-Study-Act) we have seen a progressive increase in the rate of patient signups

  10. Rufinamide for refractory focal seizures: an open-label, multicenter European study.

    Science.gov (United States)

    Coppola, Giangennaro; Zamponi, Nelia; Kluger, Gerhard; Mueller, Arndt; Anna Rita, Mazzotta; Parisi, Pasquale; Isone, Claudia; Santoro, Elena; Curatolo, Paolo; Verrotti, Alberto

    2013-01-01

    The present study aimed to assess the efficacy and tolerability of rufinamide as adjunctive drug for the treatment of a large series of children, adolescents and adults with refractory cryptogenic or symptomatic focal epilepsy. Patients were recruited in a prospective, add-on, open-label treatment study from six Italian and one German centers for pediatric and adolescent epilepsy care. Inclusion criteria were: (1) age 3 years or more; (2) diagnosis of cryptogenic or symptomatic focal epilepsy refractory to at least three previous antiepileptic drugs (AEDs), alone or in combination; (3) more than one seizure per month in the last 6 months; (4) use of at least one other AED, but no more than three, at baseline; (5) informed consent from parents and/or caregivers. Sixty-eight patients (40 males, 28 females), aged between 3 and 63 years (mean 19.9 years, median 16.0)±SD 12.58, with cryptogenic (28 pts, 41.2%) or symptomatic focal epilepsy (40 pts, 58.8%), were recruited in the study. After a mean follow-up period of 10.4±10.29 months, twenty-two patients (32.3%) had a 50-99% seizure reduction, and none became seizure-free. Twelve patients (17.6%) had a 25-49% seizure decrease, while in 30 (44.1%) seizure frequency was unchanged. A seizure worsening was reported in 5 patients (7.3%). A better response to rufinamide occurred in frontal lobe seizures (51.6%) and secondary generalized tonic-clonic seizures (50%). Rufinamide was effective against focal-onset seizures, particularly in the treatment of secondary generalized frontal lobe seizures. Copyright © 2012 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  11. Follow-up Observations of WASP-36

    Science.gov (United States)

    Kutra, Taylor; Boley, Aaron; Hughes, Anna; Hickson, Paul

    2017-06-01

    This ongoing work aims to provide follow-up observations of known transiting extrasolar planets using the 35-cm robotic telescope at The University of British Columbia's Southern Observatory (USO), located at the Cerro Tololo Inter-American Observatory (CTIO) in Chile. The observations are part of a long-term effort to search for changes in transit signatures, such as transit timing variations (TTVs) and transit duration variations (TDVs), which could indicate, for example, the presence of additional planets. To help characterize the USO for transit searches, we acquired I-band observations of WASP-36 spanning from 17 January 2017 to 27 February 2017. Three complete transits and one partial transit are included in the data. We present the analysis of these new observations and discuss potential future targets.

  12. Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial.

    Science.gov (United States)

    Stenberg, Erik; Szabo, Eva; Ågren, Göran; Ottosson, Johan; Marsk, Richard; Lönroth, Hans; Boman, Lars; Magnuson, Anders; Thorell, Anders; Näslund, Ingmar

    2016-04-02

    Small bowel obstruction due to internal hernia is a common and potentially serious complication after laparoscopic gastric bypass surgery. Whether closure of surgically created mesenteric defects might reduce the incidence is unknown, so we did a large randomised trial to investigate. This study was a multicentre, randomised trial with a two-arm, parallel design done at 12 centres for bariatric surgery in Sweden. Patients planned for laparoscopic gastric bypass surgery at any of the participating centres were offered inclusion. During the operation, a concealed envelope was opened and the patient was randomly assigned to either closure of mesenteric defects beneath the jejunojejunostomy and at Petersen's space or non-closure. After surgery, assignment was open label. The main outcomes were reoperation for small bowel obstruction and severe postoperative complications. Outcome data and safety were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01137201. Between May 1, 2010, and Nov 14, 2011, 2507 patients were recruited to the study and randomly assigned to closure of the mesenteric defects (n=1259) or non-closure (n=1248). 2503 (99·8%) patients had follow-up for severe postoperative complications at day 30 and 2482 (99·0%) patients had follow-up for reoperation due to small bowel obstruction at 25 months. At 3 years after surgery, the cumulative incidence of reoperation because of small bowel obstruction was significantly reduced in the closure group (cumulative probability 0·055 for closure vs 0·102 for non-closure, hazard ratio 0·56, 95% CI 0·41-0·76, p=0·0002). Closure of mesenteric defects increased the risk for severe postoperative complications (54 [4·3%] for closure vs 35 [2·8%] for non-closure, odds ratio 1·55, 95% CI 1·01-2·39, p=0·044), mainly because of kinking of the jejunojejunostomy. The results of our study support the routine closure of the mesenteric defects in laparoscopic

  13. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

  14. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

  15. 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.

  16. Four-year follow-up of endoscopic gastroplication for the treatment of gastroesophageal reflux disease

    Institute of Scientific and Technical Information of China (English)

    Matthijs; P; Schwartz; J; Rieneke; C; Schreinemakers; André; J; P; M; Smout

    2013-01-01

    AIM:To evaluate the long-term effect of Endocinch treatment for gastroesophageal reflux disease(GERD).METHODS:After unblinding and crossover,50 patients(32 males,18 females; mean age 46 years) with pH-proven chronic GERD were recruited from an initial randomized,placebo-controlled,single-center study,and included in the present prospective open-label follow-up study.Initially,three gastroplications using the Endocinch device were placed under deep sedation in a standardized manner.Optional retreatment was offered in the first year with 1 or 2 extra gastroplications.At baseline,3 mo after(re) treatment and yearly proton pump inhibitor(PPI) use,GERD symptoms,quality of life(QoL) scores,adverse events and treatment failures(defined as:patients using > 50% of their baseline PPI dose or receiving alternative antireflux therapy) were assessed.Intention-to-treat analysis was performed.RESULTS:Median follow-up was 48 mo [interquartile range(IQR):38-52].Three patients were lost to follow-up.In 44% of patients retreatment was done after a median of 4 mo(IQR:3-8).No serious adverse events occurred.At the end of follow-up,symptom scores and4 out of 6 QoL subscales were improved(all P < 0.01compared to baseline).However,80% of patients required PPIs for their GERD symptoms.Ultimately,64% of patients were classified as treatment failures.In 60% a post-procedural endoscopy was carried out,of which in 16% reflux esophagitis was diagnosed.CONCLUSION:In the 4-year follow-up period,the subset of GERD patients that benefit from endoscopic gastroplication kept declining gradually,nearly half opted for retreatment and 80% required PPIs eventually.

  17. Effect of Repeated Anthelminthic Treatment on Malaria in School Children in Kenya: A Randomized, Open-Label, Equivalence Trial.

    Science.gov (United States)

    Kepha, Stella; Nuwaha, Fred; Nikolay, Birgit; Gichuki, Paul; Mwandawiro, Charles S; Mwinzi, Pauline N; Odiere, Maurice R; Edwards, Tansy; Allen, Elizabeth; Brooker, Simon J

    2016-01-15

    School children living in the tropics are often concurrently infected with plasmodium and helminth parasites. It has been hypothesized that immune responses evoked by helminths may modify malaria-specific immune responses and increase the risk of malaria. We performed a randomized, open-label, equivalence trial among 2436 school children in western Kenya. Eligible children were randomized to receive either 4 repeated doses or a single dose of albendazole and were followed up during 13 months to assess the incidence of clinical malaria. Secondary outcomes were Plasmodium prevalence and density, assessed by repeat cross-sectional surveys over 15 months. Analysis was conducted on an intention-to-treat basis with a prespecified equivalence range of 20%. During 13 months of follow-up, the incidence rate of malaria was 0.27 episodes/person-year in the repeated treatment group and 0.26 episodes/person-year in the annual treatment group (incidence difference, 0.01; 95% confidence interval, -.03 to .06). The prevalence and density of malaria parasitemia did not differ by treatment group at any of the cross-sectional surveys. Our findings suggest that repeated deworming does not alter risks of clinical malaria or malaria parasitemia among school children and that school-based deworming in Africa may have no adverse consequences for malaria. NCT01658774. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America.

  18. Antidepressant monotherapy compared with combinations of antidepressants in the treatment of resistant depressive patients: a randomized, open-label study.

    Science.gov (United States)

    Bares, Martin; Novak, Tomas; Kopecek, Miloslav; Stopkova, Pavla; Cermak, Jan; Kozeny, Jiri; Höschl, Cyril

    2013-02-01

    This randomized, 6-week, open-label study compared efficacy of CAD and antidepressant monotherapies (ADM) that had been chosen according to clinical judgment of the attending psychiatrist. A total of 60 inpatients (intent-to-treat analysis) with depressive disorder (≥ 1 unsuccessful antidepressant treatment) were randomly assigned to the interventions. The responders who completed the acute phase of study, were evaluated for relapse within 2 months of follow-up treatment. The primary outcome measure was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) and response was defined as a ≥ 50% reduction of MADRS score. Mean changes in total MADRS score from baseline to week 6 for patients in both treatment modalities were not different (ADM = 13.2 ± 8.6 points; CAD = 14.5 ± 9.5 points; P = 0.58). The analysis of covariance performed for significantly higher value of imipramine equivalent dose in CAD group showed only a non-significant between-group difference for total MADRS change (P = 0.17). There were also no differences between groups in response rate (ADM = 48%; CAD = 58%) and number of drop-outs in acute treatment as well as proportion of responders' relapses in the follow-up. Both treatment modalities produced clinically relevant reduction of depressive symptomatology in acute treatment of patients with resistant depression and their effect was comparable.

  19. PF-03446962, a fully-human monoclonal antibody against transforming growth-factor β (TGFβ) receptor ALK1, in pre-treated patients with urothelial cancer: an open label, single-group, phase 2 trial.

    Science.gov (United States)

    Necchi, A; Giannatempo, P; Mariani, L; Farè, E; Raggi, D; Pennati, M; Zaffaroni, N; Crippa, F; Marchianò, A; Nicolai, N; Maffezzini, M; Togliardi, E; Daidone, M G; Gianni, A M; Salvioni, R; De Braud, F

    2014-06-01

    Despite a compelling preclinical rationale for the use of anti-angiogenic drugs in urothelial cancer (UC), short-living responses have been observed in clinical trials. PF-03446962 is a novel monoclonal antibody against Activin Receptor-Like Kinase-1 (ALK1), a type I subclass of the TGFβ receptor, with dose-dependent anti-angiogenic activity. An open label, single-group, phase 2 trial of PF-03446962 was conducted in salvage setting. Patients failing at least one chemotherapy regimen were eligible. Design provided PF-03446962 10 mg/Kg intravenously fortnightly until disease progression (PD) or unacceptable toxicity. Two-month progression-free survival (PFS) was the primary endpoint. The trial was registered with ClinicalTrials.gov, number NCT01620970. Fourteen patients were enrolled from October 2012 to July 2013. Median age was 64 years (interquartile range [IQR]: 58.2-69.5), 9 patients had a Bellmunt score of 1-2, median number of prior drugs was 3. One stable disease and 13 PD were recorded and the study met the futility stopping rule of interim analysis. Median PFS was 1.8 months (95 %CI, 1.4-2.0). After a median follow up of 7.4 months (IQR 4.5-10.9), 8 patients are alive. Median overall survival (OS) was 8 months (95 %CI, 2.9-not estimable). Most common toxicities were thrombocytopenia (G1-2 in 5 cases, persistent G3 in one, with 3 dose delays and 1 dose interruption), fatigue and abdominal pain (G1-2 in 4 cases each). Impairment of quality of life (ESAS score) was observed as well as an increase from baseline to +2 month median levels of vascular endothelial growth factor (VEGF) and interleukin-8. PF-03446962 had no activity as single drug in refractory UC and we do not recommend further investigation outside of the combination with agents targeting the VEGF receptor axis.

  20. Mindfulness meditation and cognitive behavioral therapy for insomnia: a naturalistic 12-month follow-up.

    Science.gov (United States)

    Ong, Jason C; Shapiro, Shauna L; Manber, Rachel

    2009-01-01

    A unique intervention combining mindfulness meditation with cognitive behavioral therapy for insomnia (CBT-I) has been shown to have acute benefits at posttreatment in an open label study. The aim of the present study was to examine the long-term effects of this integrated intervention on measures of sleep and sleep-related distress in an attempt to characterize the natural course of insomnia following this treatment and to identify predictors of poor long-term outcome. Analyses were conducted on 21 participants, who provided follow-up data at six and 12 months posttreatment. At each time point, participants completed one week of sleep and meditation diaries and questionnaires related to mindfulness, sleep, and sleep-related distress, including the Pre-Sleep Arousal Scale, the Glasgow Sleep Effort Scale, the Kentucky Inventory of Mindfulness Skills, and the Insomnia Episode Questionnaire. Analyses examining the pattern of change across time (baseline, end of treatment, six months, and 12 months) revealed that several sleep-related benefits were maintained during the 12-month follow-up period. Participants who reported at least one insomnia episode (>or=1 month) during the follow-up period had higher scores on the Pre-Sleep Arousal Scale (P insomnia episodes. Correlations between mindfulness skills and insomnia symptoms revealed significant negative correlations (P insomnia. These results suggest that most sleep-related benefits of an intervention combining CBT-I and mindfulness meditation were maintained during the 12-month follow-up period, with indications that higher presleep arousal and sleep effort at end of treatment constitute a risk for occurrence of insomnia during the 12 months following treatment.

  1. 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

  2. A randomised, open-label, comparative study of tranexamic acid microinjections and tranexamic acid with microneedling in patients with melasma

    Directory of Open Access Journals (Sweden)

    Leelavathy Budamakuntla

    2013-01-01

    Full Text Available Background: Melasma is a common cause of facial hyperpigmentation with significant cosmetic deformity. Although several treatment modalities are available, none is satisfactory. Aim: To compare the therapeutic efficacy and safety of tranexamic acid (TA microinjections versus tranexamic acid with microneedling in melasma. Materials and Methods: This is a prospective, randomised, open-label study with a sample size of 60; 30 in each treatment arms. Thirty patients were administered with localised microinjections of TA in one arm, and other 30 with TA with microneedling. The procedure was done at monthly intervals (0, 4 and 8 weeks and followed up for three consecutive months. Clinical images were taken at each visit including modified Melasma Area Severity Index MASI scoring, patient global assessment and physician global assessment to assess the clinical response. Results: In the microinjection group, there was 35.72% improvement in the MASI score compared to 44.41% in the microneedling group, at the end of third follow-up visit. Six patients (26.09% in the microinjections group, as compared to 12 patients (41.38% in the microneedling group, showed more than 50% improvement. However, there were no major adverse events observed in both the treatment groups. Conclusions: On the basis of these results, TA can be used as potentially a new, effective, safe and promising therapeutic agent in melasma. The medication is easily available and affordable. Better therapeutic response to treatment in the microneedling group could be attributed to the deeper and uniform delivery of the medication through microchannels created by microneedling.

  3. A Randomised, Open-label, Comparative Study of Tranexamic Acid Microinjections and Tranexamic Acid with Microneedling in Patients with Melasma

    Science.gov (United States)

    Budamakuntla, Leelavathy; Loganathan, Eswari; Suresh, Deepak Hurkudli; Shanmugam, Sharavana; Suryanarayan, Shwetha; Dongare, Aparna; Venkataramiah, Lakshmi Dammaningala; Prabhu, Namitha

    2013-01-01

    Background: Melasma is a common cause of facial hyperpigmentation with significant cosmetic deformity. Although several treatment modalities are available, none is satisfactory. Aim: To compare the therapeutic efficacy and safety of tranexamic acid (TA) microinjections versus tranexamic acid with microneedling in melasma. Materials and Methods: This is a prospective, randomised, open-label study with a sample size of 60; 30 in each treatment arms. Thirty patients were administered with localised microinjections of TA in one arm, and other 30 with TA with microneedling. The procedure was done at monthly intervals (0, 4 and 8 weeks) and followed up for three consecutive months. Clinical images were taken at each visit including modified Melasma Area Severity Index MASI scoring, patient global assessment and physician global assessment to assess the clinical response. Results: In the microinjection group, there was 35.72% improvement in the MASI score compared to 44.41% in the microneedling group, at the end of third follow-up visit. Six patients (26.09%) in the microinjections group, as compared to 12 patients (41.38%) in the microneedling group, showed more than 50% improvement. However, there were no major adverse events observed in both the treatment groups. Conclusions: On the basis of these results, TA can be used as potentially a new, effective, safe and promising therapeutic agent in melasma. The medication is easily available and affordable. Better therapeutic response to treatment in the microneedling group could be attributed to the deeper and uniform delivery of the medication through microchannels created by microneedling. PMID:24163529

  4. 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

  5. Aquatic therapy versus conventional land-based therapy for Parkinson's disease: an open-label pilot study.

    Science.gov (United States)

    Vivas, Jamile; Arias, Pablo; Cudeiro, Javier

    2011-08-01

    To assess and compare 2 different protocols of physiotherapy (land or water therapy) for people with Parkinson's disease (PD) focused on postural stability and self-movement, and to provide methodological information regarding progression within the program for a future larger trial. Randomized, controlled, open-label pilot trial. Outpatients, Parkinson's disease Center of Ferrol-Galicia (Spain). Individuals (N=11) with idiopathic PD in stages 2 or 3 according to the Hoehn and Yahr Scale completed the investigation (intervention period plus follow-up). After baseline evaluations, participants were randomly assigned to a land-based therapy (active control group) or a water-based therapy (experimental group). Participants underwent individual sessions for 4 weeks, twice a week, for 45 minutes per session. Both interventions were matched in terms of exercise features, which were structured in stages with clear objectives and progression criteria to pass to the next phase. Participants underwent a first baseline assessment, a posttest immediately after 4 weeks of intervention, and a follow-up assessment after 17 days. Evaluations were performed OFF-dose after withholding medication for 12 hours. Functional assessments included the Functional Reach Test (FRT), the Berg Balance Scale (BBS), the UPDRS, the 5-m walk test, and the Timed Up and Go test. A main effect of both therapies was seen for the FRT. Only the aquatic therapy group improved in the BBS and the UPDRS. In this pilot study, physiotherapy protocols produced improvement in postural stability in PD that was significantly larger after aquatic therapy. The intervention protocols are shown to be feasible and seem to be of value in amelioration of postural stability-related impairments in PD. Some of the methodological aspects detailed here can be used to design larger controlled trials. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  6. Open-label study of olanzapine in children with pervasive developmental disorder.

    NARCIS (Netherlands)

    Kemner, C.; Swinkels, S.H.N.; Jonge, M.J.A. de; Tuynman-Qua, H.G.; Engeland, H.M. van

    2002-01-01

    The effects of olanzapine on the symptomatology of children with pervasive developmental disorder with emphasis on problems of communication and the safety of the drug were investigated in a 3-month open-label, open-dosage study. Participating in the study were 25 children age 6 to 16 years with a d

  7. 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…

  8. 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…

  9. 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…

  10. Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial.

    NARCIS (Netherlands)

    R. van Linschoten (Robbart); M. van Middelkoop (Marienke); M.Y. Berger (Marjolein); E.M. Heintjes (Edith); J.A.N. Verhaar (Jan); S.P. Willemsen (Sten); B.W. Koes (Bart); S.M. Bierma-Zeinstra (Sita)

    2009-01-01

    textabstractOBJECTIVE: To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. DESIGN: Open label randomised controlled trial. SETTING: General practice and sport physician practic

  11. A randomized open-label comparison of the impact of olanzapine versus risperidone on sexual functioning

    NARCIS (Netherlands)

    Knegtering, H; Boks, M; Blijd, C; Castelein, S; Van den Bosch, RJ; Wiersma, D

    2006-01-01

    The objective of this study was to compare sexual functioning in patients treated with olanzapine or risperidone. This open-label trial included 46 patients randomized to olanzapine (5-15mg/d) or risperidone (1-6mg/d) for 6 weeks. We used sexual dysfunction was assessed by a semistructured interview

  12. Open-label study of olanzapine in children with pervasive developmental disorder.

    NARCIS (Netherlands)

    Kemner, C.; Swinkels, S.H.N.; Jonge, M.J.A. de; Tuynman-Qua, H.G.; Engeland, H.M. van

    2002-01-01

    The effects of olanzapine on the symptomatology of children with pervasive developmental disorder with emphasis on problems of communication and the safety of the drug were investigated in a 3-month open-label, open-dosage study. Participating in the study were 25 children age 6 to 16 years with a

  13. Rotigotine transdermal system for long-term treatment of patients with advanced Parkinson's disease: results of two open-label extension studies, CLEOPATRA-PD and PREFER.

    Science.gov (United States)

    LeWitt, Peter A; Boroojerdi, Babak; Surmann, Erwin; Poewe, Werner

    2013-07-01

    Open-label extensions [studies SP516 (NCT00501969) and SP715 (NCT00594386)] of the CLEOPATRA-PD and PREFER studies were conducted to evaluate the safety, tolerability and efficacy of the dopaminergic agonist, rotigotine, over several years of follow-up in patients with advanced Parkinson's disease (PD). Eligible subjects completing the double-blind trials received open-label adjunctive rotigotine (≤16 mg/24 h) for up to 4 and 6 years in Studies SP516 and SP715, respectively. Safety and tolerability were assessed using adverse events, vital signs and laboratory parameters, and efficacy assessed using the unified Parkinson's disease rating scale (UPDRS). Of the 395 and 258 patients enrolled in the SP516 and SP715 studies, 48 and 45 % completed, respectively. Adverse events were typically dopaminergic effects [e.g., somnolence (18-25 %/patient-year), insomnia (5-7 %/patient-year), dyskinesias (4-8 %/patient-year) and hallucinations (4-8 %/patient-year)], or related to the transdermal application of a patch (application site reactions: 14-15 %/patient-year). There were no clinically relevant changes in vital signs or laboratory parameters in either study. Mean UPDRS part II (activities of daily living) and part III (motor function) total scores improved from double-blind baseline during dose titration, then gradually declined over the maintenance period. In study SP516, mean UPDRS part II and III total scores were 0.8 points above and 2.8 points below double-blind baseline, respectively, at end of treatment. In study SP715, mean UPDRS part II and III total scores were 4.1 points above and 0.2 points below baseline, respectively, at end of treatment. In these open-label studies, adjunctive rotigotine was efficacious with an acceptable safety and tolerability profile in patients with advanced PD for up to 6 years.

  14. Open-label study of the short-term effects of memantine on FDG-PET in frontotemporal dementia

    Directory of Open Access Journals (Sweden)

    Chow TW

    2011-07-01

    metabolic activity in bilateral insulae and the left orbitofrontal cortex (P < 0.01. The increase on FDG-PET did not correlate with changes on behavioral inventories. Post hoc analysis indicated that semantic dementia participants drove this finding.Conclusion: This open-label clinical PET study suggests that memantine induces an increase in metabolism in the salience network in FTD. A placebo-controlled follow-up study is warranted.Keywords: Alzheimer's disease, frontotemporal dementia, metabolism, PET scan, semantic dementia 

  15. Clinical and hepatic evaluation in adult dengue patients: a prospective two-month cohort study

    Directory of Open Access Journals (Sweden)

    Ricardo Tristão-Sá

    2012-12-01

    Full Text Available INTRODUCTION: To analyze the liver dysfunction and evolution of signs and symptoms in adult dengue patients during a two-month follow-up period. METHODS: A prospective cohort study was conducted in Campos dos Goytacazes, Rio de Janeiro, Brazil, from January to July, 2008. The evolution of laboratory and clinical manifestations of 90 adult dengue patients was evaluated in five scheduled visits within a two-month follow-up period. Twenty controls were enrolled for the analysis of liver function. Patients with hepatitis B, hepatitis C, those known to be human immunodeficiency virus (HIV seropositive and pregnant women were excluded from the study. RESULTS: At the end of the second month following diagnosis, we observed that symptoms persisted in 33.3% (30/90 of dengue patients. We also observed that, 57.7% (15/26 of the symptoms persisted at the end of the second month. The most persistent symptoms were arthralgia, fatigue, weakness, adynamia, anorexia, taste alteration, and hair loss. Prior dengue virus (DENV infection did not predispose patients to a longer duration of symptoms. Among hepatic functions, transaminases had the most remarkable elevation and in some cases remained elevated up to the second month after the disease onset. Alanine aminotransferase (ALT levels overcame aspartate aminotransferase (AST during the convalescent period. Male patients were more severely affected than females. CONCLUSIONS: Dengue fever may present a wide number of symptoms and elevated liver transaminases at the end of the second month.

  16. Alberta Euthanasia Survey: 3-year follow-up.

    OpenAIRE

    Verhoef, M.J.; Kinsella, T D

    1996-01-01

    OBJECTIVE: To determine whether the opinions of Alberta physicians about active euthanasia had changed and to assess the determinants of potential changes in opinion. DESIGN: Follow-up survey (mailed questionnaire) of physicians included in the 1991 Alberta Euthanasia Survey. SETTING: Alberta. PARTICIPANTS: Of the 1391 physicians who participated in the 1991 survey 1291 (93%) had indicated that they were willing to take part in a follow-up survey. A follow-up questionnaire was mailed in 1994 ...

  17. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial.

    Science.gov (United States)

    Devinsky, Orrin; Marsh, Eric; Friedman, Daniel; Thiele, Elizabeth; Laux, Linda; Sullivan, Joseph; Miller, Ian; Flamini, Robert; Wilfong, Angus; Filloux, Francis; Wong, Matthew; Tilton, Nicole; Bruno, Patricia; Bluvstein, Judith; Hedlund, Julie; Kamens, Rebecca; Maclean, Jane; Nangia, Srishti; Singhal, Nilika Shah; Wilson, Carey A; Patel, Anup; Cilio, Maria Roberta

    2016-03-01

    Almost a third of patients with epilepsy have a treatment-resistant form, which is associated with severe morbidity and increased mortality. Cannabis-based treatments for epilepsy have generated much interest, but scientific data are scarce. We aimed to establish whether addition of cannabidiol to existing anti-epileptic regimens would be safe, tolerated, and efficacious in children and young adults with treatment-resistant epilepsy. In this open-label trial, patients (aged 1-30 years) with severe, intractable, childhood-onset, treatment-resistant epilepsy, who were receiving stable doses of antiepileptic drugs before study entry, were enrolled in an expanded-access programme at 11 epilepsy centres across the USA. Patients were given oral cannabidiol at 2-5 mg/kg per day, up-titrated until intolerance or to a maximum dose of 25 mg/kg or 50 mg/kg per day (dependent on study site). The primary objective was to establish the safety and tolerability of cannabidiol and the primary efficacy endpoint was median percentage change in the mean monthly frequency of motor seizures at 12 weeks. The efficacy analysis was by modified intention to treat. Comparisons of the percentage change in frequency of motor seizures were done with a Mann-Whitney U test. Between Jan 15, 2014, and Jan 15, 2015, 214 patients were enrolled; 162 (76%) patients who had at least 12 weeks of follow-up after the first dose of cannabidiol were included in the safety and tolerability analysis, and 137 (64%) patients were included in the efficacy analysis. In the safety group, 33 (20%) patients had Dravet syndrome and 31 (19%) patients had Lennox-Gastaut syndrome. The remaining patients had intractable epilepsies of different causes and type. Adverse events were reported in 128 (79%) of the 162 patients within the safety group. Adverse events reported in more than 10% of patients were somnolence (n=41 [25%]), decreased appetite (n=31 [19%]), diarrhoea (n=31 [19%]), fatigue (n=21 [13%]), and convulsion (n

  18. Leisure of Opiate Addicts at Posttreatment Follow-Up.

    Science.gov (United States)

    Simpson, D. Dwayne; And Others

    1981-01-01

    Comparisons of self-reported leisure showed an overall shift toward more positive, socially accepted leisure activities at follow-up. More free time was spent with family and friends who did not use drugs. Positive leisure at follow-up was related to favorable outcomes on drug use, criminality, and productive activities. (Author)

  19. 10 CFR 1022.17 - Follow-up.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Follow-up. 1022.17 Section 1022.17 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) COMPLIANCE WITH FLOODPLAIN AND WETLAND ENVIRONMENTAL REVIEW REQUIREMENTS Procedures for Floodplain and Wetland Reviews § 1022.17 Follow-up. For those DOE actions taken in...

  20. Shelf acetabuloplasty for Perthes' disease: 12-year follow-up.

    NARCIS (Netherlands)

    Geest, I.C.M. van der; Kooijman, H.M.; Spruit, M.; Anderson, P.G.; Smet, P.A.G.M. de

    2001-01-01

    The goal of all therapies for Perthes' disease is to achieve an optimal shape of the acetabulum and an optimal coverage of the femoral head. Thirty patients who were included in this follow-up study (mean follow-up 12 years) underwent a shelf acetabuloplasty for Catterall group III or IV. The mean I

  1. 38 CFR 41.315 - Audit findings follow-up.

    Science.gov (United States)

    2010-07-01

    ... action plan to address each audit finding included in the current year auditor's reports. The corrective... findings follow-up. (a) General. The auditee is responsible for follow-up and corrective action on all... reference numbers the auditor assigns to audit findings under § 41.510(c). Since the summary schedule may...

  2. The value of gynecologic cancer follow-up

    DEFF Research Database (Denmark)

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

    2010-01-01

    . 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...

  3. Follow-up schedules after treatment for malignant melanoma

    NARCIS (Netherlands)

    Francken, A. B.; Accortt, N. A.; Shaw, H. M.; Colman, M. H.; Wiener, M.; Soong, S. -J.; Hoekstra, H. J.; Thompson, J. F.

    2008-01-01

    Background: Existing follow-up guidelines after treatment for melanoma are based largely on dated literature and historical precedent. This study aimed to calculate recurrence rates and establish prognostic factors for recurrence to help redesign a follow-up schedule. Methods: Data were retrieved

  4. The Effects of Drug Education at Follow-Up.

    Science.gov (United States)

    Moskowitz, Joel M.; And Others

    1984-01-01

    Presents a one-year follow-up of a drug education course for 500 junior high school students. Analyses of variance and covariance were performed on class-level data collected at follow-up. None of the short-term effects of the course sustained. (JAC)

  5. Safety and Outcomes of Open-Label Deferasirox Iron Chelation Therapy for Mucormycosis▿

    OpenAIRE

    2009-01-01

    We sought to describe the safety profile of open-label, adjunctive deferasirox iron chelation therapy in eight patients with biopsy-proven mucormycosis. Deferasirox was administered for an average of 14 days (range, 7 to 21) at 5 to 20 mg/kg of body weight/day. The only adverse effects attributable to deferasirox were rashes in two patients. Deferasirox treatment was not associated with changes in renal or liver function, complete blood count, or transplant immunosuppressive levels. Thus, def...

  6. A 10-Month, Open-Label Evaluation of Desvenlafaxine in Outpatients With Major Depressive Disorder

    Science.gov (United States)

    Pitrosky, Bruno; Padmanabhan, S. Krishna; Rosas, Gregory R.

    2011-01-01

    Background: The primary objective was to evaluate the long-term safety of desvenlafaxine (administered as desvenlafaxine succinate) during open-label treatment in adult outpatients with a primary DSM-IV diagnosis of major depressive disorder (MDD). Method: Depressed adult outpatients (≥ 18 years) who had completed 8-week, double-blind therapy (desvenlafaxine, venlafaxine extended release, or placebo) in a phase 3 study of desvenlafaxine for MDD received up to 10 months of open-label treatment with flexible-dose desvenlafaxine (200 to 400 mg/d). Safety assessments included physical examination, measurement of weight and vital signs, laboratory determinations, and 12-lead electrocardiogram recordings. Adverse events (AEs) and discontinuations due to AEs were monitored throughout the trial. The primary efficacy outcome was mean change from baseline on 17-item Hamilton Depression Rating Scale (HDRS-17) total score. The trial was conducted from August 2003 to March 2006. Results: The safety population included 1,395 patients who took at least 1 dose of open-label desvenlafaxine. Treatment-emergent AEs were reported by 1,238 of 1,395 patients (89%) during the open-label, on-therapy period. Treatment-emergent AEs reported by 10% or more patients were headache, nausea, hyperhidrosis, dizziness, dry mouth, insomnia, upper respiratory infection, nasopharyngitis, and fatigue. Adverse events were the primary reason for study discontinuation in 296 of 1,395 patients (21%). Ten patients (Desvenlafaxine can be safely administered for up to 12 months. No new safety findings were observed in this study. Trial Registration: clinicaltrials.gov Identifier: NCT01309542 PMID:21977353

  7. 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.

  8. Urological outcome after myelomeningocele: 20 years of follow-up

    DEFF Research Database (Denmark)

    Thorup, Jørgen Mogens; Biering-Sorensen, Fin; Cortes, Dina

    2011-01-01

    Study Type - Therapy (case series)¿Level of Evidence 4 OBJECTIVES: To evaluate the urological outcome in a long-term follow-up of individuals with myelomeningocele and relate the findings obtained to urodynamic variables in childhood. MATERIAL AND METHODS: Individuals with myelomeningocele born....... In childhood and at follow-up, kidney function was estimated with renography and isotope-glomerular filtration rate examinations. RESULTS: In total, 52 individuals (28 boys and 24 girls) aged 19-41 years (median, 29 years) had follow-up. Of these, 37 (71%) individuals had bilateral normal kidney function...

  9. The efficacy of the modified Atkins diet in North Sea Progressive Myoclonus Epilepsy: an observational prospective open-label study.

    Science.gov (United States)

    van Egmond, Martje E; Weijenberg, Amerins; van Rijn, Margreet E; Elting, Jan Willem J; Gelauff, Jeannette M; Zutt, Rodi; Sival, Deborah A; Lambrechts, Roald A; Tijssen, Marina A J; Brouwer, Oebele F; de Koning, Tom J

    2017-03-07

    North Sea Progressive Myoclonus Epilepsy is a rare and severe disorder caused by mutations in the GOSR2 gene. It is clinically characterized by progressive myoclonus, seizures, early-onset ataxia and areflexia. As in other progressive myoclonus epilepsies, the efficacy of antiepileptic drugs is disappointingly limited in North Sea Progressive Myoclonus Epilepsy. The ketogenic diet and the less restrictive modified Atkins diet have been proven to be effective in other drug-resistant epilepsy syndromes, including those with myoclonic seizures. Our aim was to evaluate the efficacy of the modified Atkins diet in patients with North Sea Progressive Myoclonus Epilepsy. Four North Sea Progressive Myoclonus Epilepsy patients (aged 7-20 years) participated in an observational, prospective, open-label study on the efficacy of the modified Atkins diet. Several clinical parameters were assessed at baseline and again after participants had been on the diet for 3 months. The primary outcome measure was health-related quality of life, with seizure frequency and blinded rated myoclonus severity as secondary outcome measures. Ketosis was achieved within 2 weeks and all patients completed the 3 months on the modified Atkins diet. The diet was well tolerated by all four patients. Health-related quality of life improved considerably in one patient and showed sustained improvement during long-term follow-up, despite the progressive nature of the disorder. Health-related quality of life remained broadly unchanged in the other three patients and they did not continue the diet. Seizure frequency remained stable and blinded rating of their myoclonus showed improvement, albeit modest, in all patients. This observational, prospective study shows that some North Sea Progressive Myoclonus Epilepsy patients may benefit from the modified Atkins diet with sustained health-related quality of life improvement. Not all our patients continued on the diet, but nonetheless we show that the modified

  10. Eldecalcitol improves muscle strength and dynamic balance in postmenopausal women with osteoporosis: an open-label randomized controlled study.

    Science.gov (United States)

    Saito, Kimio; Miyakoshi, Naohisa; Matsunaga, Toshiki; Hongo, Michio; Kasukawa, Yuji; Shimada, Yoichi

    2016-09-01

    The antifracture efficacy of vitamin D in osteoporosis is due to its direct action on bones and indirect extraskeletal effects to prevent falls. Eldecalcitol is an analog of active vitamin D3 that improves bone mineral density and reduces the risk of osteoporotic fractures. However, the effects of eldecalcitol on muscle strength and static and dynamic postural balance are unclear. In this open-label randomized controlled study, we assessed the effects of eldecalcitol on muscle strength and static and dynamic postural balance in 50 postmenopausal women (mean age 74 years) with osteoporosis treated with bisphosphonate. Participants were randomly divided into a bisphosphonate group (alendronate at 35 mg/week; n = 25) or an eldecalcitol group (eldecalcitol at 0.75 μg/day and alendronate at 35 mg/week; n = 25) and were followed up for 6 months. Trunk muscle strength, including back extensor strength and iliopsoas muscle strength, was measured. Static standing balance was evaluated and the one leg standing test was performed to assess static postural balance. Dynamic sitting balance was evaluated and the 10-m walk test, functional reach test, and timed up and go test were performed to assess dynamic postural balance. At 6 months, there were no significant changes in any measure of muscle strength or balance in the bisphosphonate group, whereas eldecalcitol significantly increased back extensor strength (p = 0.012) and iliopsoas muscle strength (p = 0.035). Eldecalcitol also significantly improved findings on the timed up and go test (p = 0.001) and dynamic sitting balance (p = 0.015) at 6 months. These results with eldecalcitol may have an impact on prevention of falls.

  11. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients.

    Science.gov (United States)

    Flechner, Stuart M; Gurkan, Alihan; Hartmann, Anders; Legendre, Christophe M; Russ, Graeme R; Campistol, Josep M; Schena, Francesco P; Hahn, Carolyn M; Li, Huihua; Korth-Bradley, Joan M; Tai, Sandi See; Schulman, Seth L

    2013-05-27

    Despite a decreased incidence of acute rejection and early renal allograft loss due to calcineurin inhibitors (CNIs) in transplant recipients, nephrotoxicity associated with long-term CNI use remains an important issue. This study evaluated whether a CNI-free regimen, including sirolimus, mycophenolate mofetil, corticosteroids, and anti-interleukin-2 receptor antibody induction, results in improved long-term renal function. This open-label, randomized, parallel group, comparative study in primary de novo renal transplant recipients was planned for 48 months but terminated early because of high acute rejection rates in the sirolimus arm. Enrollment was stopped after ≈12 months, with 475 transplanted patients randomized (2:1) to sirolimus (n=314) or cyclosporine A (CsA) treatment (n=161). Mean length of follow-up after transplantation was 190 days; this article focuses on available data through 6 months. Mean±SD on-therapy Nankivell-calculated glomerular filtration rate was not significantly different between the sirolimus (69.1±18.7 mL/min) and CsA (66.0±15.2 mL/min) treatment groups. Occurrence and length of delayed graft function was not significantly different between groups. Patients in the sirolimus group experienced numerically lower survival rates (96.9% vs. 99.4%; P=0.14), with nine deaths reported with sirolimus and one with CsA; higher rates of biopsy-confirmed acute rejection (21.4% vs. 6.1%; P<0.001); and higher rates of discontinuations due to adverse events (17.4% vs. 6.8%; P=0.001). A sirolimus-based, CNI-free immunosuppressive regimen, when used with mycophenolate mofetil, corticosteroids, and anti-interleukin-2 receptor antibody induction, was associated with high rates of biopsy-confirmed acute rejection compared with CsA-based immunosuppression and is not recommended.

  12. 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...

  13. A CLINICAL AND FOLLOW UP STUDY OF ATYPICAL PSYCHOSES

    Science.gov (United States)

    Singh, Gurmeet; Sachdev, J. S.

    1980-01-01

    SUMMARY Twenty-two cases who fulfilled the criteria of having atypical manifestation at any stage of illness and had minimum follow up of three years were studied in detail. Their family history and follow up was analysed. The findings of the present study suggest that the cases showing admixture of schizophrenic and affective symptoms are probably a variant of affective disorders although a possibility of their being a third independent psychosis cannot be ruled out. PMID:22065727

  14. 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....

  15. Paradoxes of follow-up - health professionals' views on follow-up after surgical treatment in gynecological cancer

    DEFF Research Database (Denmark)

    Dahl, Lotte; Wittrup, Inge; Petersen, Lone Kjeld

    2015-01-01

    : A qualitative approach was undertaken with semi-structured focus group interviews. Three focus group interviews were conducted at neutral ground. One group with onco-gynecologists, one group with specialist nurses, and one mixed group. The main themes of the interviewguide were: Existing follow-up program, life...... and appraisal from the patients. A disadvantage was the inadequate use of the nurses' main competencies. Some dilemmas were described by the nurses as well as doctors: First, both groups were aware of the existing evidence that attendance of follow-up programs may not improve survival and yet, health...... that the existing follow-up regime contains several dilemmas. According to the health professionals, future follow-up must be more individualized, and a shift in focus is needed from relapse to quality of life after cancer....

  16. Congenital syphilis in a two-month-old infant

    Directory of Open Access Journals (Sweden)

    Daniele Serranti

    2011-06-01

    Full Text Available This report describes a rare case of congenital syphilis in a two-month-old Romanian infant. Diagnosis was possible when the baby showed decrease in the left upper limb movements and a papular rash. Her father had been infected and transmitted the infection to the mother, who had two non-treponemal serological tests during pregnancy, both with negative results. Congenital syphilis was confirmed by serological tests and the newborn was successfully treated. A global overview on diagnosis and treatment of children with suspected congenital syphilis is presented.

  17. 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.

  18. Safety and Outcomes of Open-Label Deferasirox Iron Chelation Therapy for Mucormycosis▿

    Science.gov (United States)

    Spellberg, Brad; Andes, David; Perez, Mario; Anglim, Anne; Bonilla, Hector; Mathisen, Glenn E.; Walsh, Thomas J.; Ibrahim, Ashraf S.

    2009-01-01

    We sought to describe the safety profile of open-label, adjunctive deferasirox iron chelation therapy in eight patients with biopsy-proven mucormycosis. Deferasirox was administered for an average of 14 days (range, 7 to 21) at 5 to 20 mg/kg of body weight/day. The only adverse effects attributable to deferasirox were rashes in two patients. Deferasirox treatment was not associated with changes in renal or liver function, complete blood count, or transplant immunosuppressive levels. Thus, deferasirox appears safe as an adjunctive therapy for mucormycosis. PMID:19433555

  19. [Telemedicine in pacemaker therapy and follow-up].

    Science.gov (United States)

    Schuchert, A

    2009-12-01

    Present-day remote systems for cardiovascular implantable electronic devices (CIEDs) provide, in contrast to previous solutions, a broad range of data about the patient and the implanted device ("remote control"). Telemedicine includes remote monitoring as well as remote follow-up: Remote monitoring is the continual interrogation of the device to detect patient- or device-related adverse events earlier than with standard follow-up visits. Remote follow-up aims to replace scheduled and unscheduled face-to-face follow-up visits due to the interrogation of the automatic pacemaker functions. Currently available remote systems, such as Home Monitoring, CareLink, Merlin.net, and Latitude, have in common that they interrogate the device, send these data to a server, and provide the data to the physician on a secured web site. Automatic wireless interrogation of the device is the preferred solution; however, the devices must have been equipped with a micro-antenna, which is usually restricted to more recent pacemaker models. Knowledge about remote control in pacemaker patients is limited, because most remote applications were evaluated in ICD and CRT patients. While the most frequently reported clinical event in pacemaker patients is atrial fibrillation, the impact in routine clinical follow-up still has to be evaluated in detail. Device-related adverse events are rare. Large, long-term, randomized trials are comparing remote and conventional approaches with the aim of demonstrating the benefits of telemedicine in this patient group.

  20. Follow-up care of children suffered from burns

    Directory of Open Access Journals (Sweden)

    Константин Александрович Афоничев

    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.

  1. Cohort follow-up: the 21st century procedures.

    Science.gov (United States)

    Bahr, Debra E; Hughes, Therese; Aldrich, Timothy E; Silver, Kenneth Z; Brion, Gall M

    2009-01-01

    The basic logic of designing an occupational cohort study has changed little since William R. Gaffey outlined the issues of follow-up, measurement of exposure, and analysis of data. However, many new avenues of tracking workers for epidemiological studies have been developed since Gaffey wrote his paper in 1973. Many disease registries also perform follow-up of subjects for vital status determination, so the procedures used with this process are common to the two applications. This article speaks to cohort construction for this occupational research as well as describes the 2007 methods for vital status follow-up. Rises in concern about work-related disease risks and the scientific resources for performing these studies coincided with the computer revolution. Government and private sources of data on vital status have changed in several ways over the 35 years since Gaffey's seminal paper. Some systems make the process of follow-up more rapid and productive, and some barriers have been imposed as societal concerns for privacy have risen. We describe the process of linking 5 sources of data to compile a roster of 6,820 workers employed at the Paducah Gaseous Diffusion Plant from 1953 to 2003. The record linkage processes achieved a final death cohort of 1672 deaths--the ascertainment of these deaths (by time period) was 1379 (1979-2003) and 293 (1953-1978); follow-up then was 100% for this cohort.

  2. Effects of Qianlie'an(前列安) Suppository in Patients with Chronic Prostatitis Syndrome: A Randomized Open-Labelled Prospective and Controlled Trial

    Institute of Scientific and Technical Information of China (English)

    邢俊平; 陈兴发; 杨志尚; 王明珠; 贺大林

    2003-01-01

    Objective: To evaluate the clinical efficacy of Qianlie'an(前列安,QLA) suppository via anal route administration in treating chronic prostatitis syndrome. Methods: A randomized open-labelled prospective controlled trial was carried out. The total of 120 patients with chronic prostatitis syndrome were randomly divided into 2 groups: 60 patients in the treated group who were treated with QLA suppository combined with ofloxacin, and the other 60 patients in the control group who were given ofloxacin alone. The efficacy was evaluated by WBC count in the expressed prostatic secretion (EPS) and the Chronic Prostatitis Symptom Index (CPSI) made by the National Institute of Health (NIH). The clinical effects were also observed in a 4-week follow-up. Results: All but six cases completed the trial and the follow-up.It showed that in the treated group recovery rate was 17. 2%, markedly effective rate 34. 5%, effective rate 32.8%, total markedly effective rate 51.7%, and total effective rate 84. 5%, all of which were superior to those in the control group (total markedly effective rate 32.1% and total effective rate 66.1%, respectively), P<0.01. Conclusion: Administration of QLA suppository via anal route combined with oral antibiotics is an effective therapy for chronic prostatitis syndrome. It can relieve the symptoms of chronic prostatitis syndrome markedly and rapidly. It is a new choice for treatment of the disease.

  3. Experience from multidisciplinary follow-up on critically ill patients treated in an intensive care unit.

    Science.gov (United States)

    Fonsmark, Lise; Rosendahl-Nielsen, Mette

    2015-05-01

    International literature describes that former intensive care unit (ICU) patients suffer considerable physical and neuropsychological complications. Systematic data on Danish ICU survivors are scarce as standardised follow-up after intensive care has yet to be described. This article describes and evaluates the knowledge gained from outpatient follow-up at a tertiary intensive care unit at Rigshospitalet, Copenhagen, during a three-year period. A total of 101 adult former ICU patients attended the outpatient clinic over a three-year period. Patients included were medical and surgical patients with a length of stay exceeding four days. Patients attended the clinic after discharge from hospital and for a minimum of two months from their discharge from the ICU. The patients were assessed for physical, neuropsychological and psychological problems and, if necessary, further treatment or rehabilitation was initiated. Reduced physical ability was seen in 82%. A total of 89% suffered a substantial weight loss. 83.2% had signs indicating acute brain dysfunction during the ICU stay, and approximately half of the patients still had cognitive problems. A total of 66 interventions were initiated. Our data confirmed that a large proportion of ICU survivors suffer considerable long-term physical and neuropsychological sequelae. Intensive care follow-up may contribute to address these specific problems and to initiate the needed interventions. Research is needed to determine whether specialised rehabilitation is required. not relevant. not relevant.

  4. Changes of Platelet Indices in Juvenile Idiopathic Arthritis in Acute Phase and After Two Months Treatment

    Directory of Open Access Journals (Sweden)

    Marjan Vakili

    2016-05-01

    Full Text Available Background Various indices have been raised as predictors of activity and severity of juvenile idiopathic arthritis. Objectives This study was conducted to investigate the changes of platelet indices in acute phase and two months after treatment in these patients. Patients and Methods In a cohort study, platelet count, mean platelet volume (MPV, platelet distribution width (PDW, plateletcrit (PCT were evaluated in children referred to children’s medical center, Tehran due to juvenile idiopathic arthritis from March 2013 to March 2014 during the acute phase and two months after standard treatment. The statistical data were analyzed by SPSS 19 software, and the significance level was set as P < 0.05. Results In this study, 55 children (24 boys and 31 girls with mean ± SD age of 7.50 ± 3.35 years were studied. The mean ± SD value of platelet count was 441872.7 ± 151836.9 in the acute phase and reached 395418.2 ± 119601.6 two months after treatment (P = 0.01. The mean ± SD PCT in the acute phase of various subtypes of the disease was 0.32 ± 0.11, which reached 0.29 ± 0.10 after treatment (P = 0.09. However, the PDW range in different subtypes of the disease reached 13.4 ± 8.0 from 13.9 ± 2.9 and MPV reached 8.7 ± 0.9 from 8.8 ± 1.1 after treatment, but they were not significantly different from the results in the acute phase (P = 0.5. Conclusions Platelet count is one of the most remarkable indices in JIA. Evaluation of PCT can also help determine the severity of the inflammatory process in the follow-up and treatment process.

  5. Efficacy and utility of phone call follow-up after pediatric general surgery versus traditional clinic follow-up.

    Science.gov (United States)

    Fischer, Kevin; Hogan, Virginia; Jager, Alesha; von Allmen, Daniel

    2015-01-01

    Typical follow-up for surgical procedures consists of an interim history and brief focused physical examination. These appointments occupy clinic resources, require a time investment by the family, and rarely identify problems. Previous studies have demonstrated the safety of a postoperative phone call. Compare a traditional in-person clinic postoperative visit with postoperative phone call follow-up regarding patient satisfaction, rate of successful follow-up, and clinic resource utilization in a large academic practice. A retrospective review of charts of patients who underwent select surgical procedures, along with a review of the clinic schedule for the same time period. Efficacy, patient/family satisfaction, and impact on the clinic. Families were contacted by telephone two weeks after select surgical procedures to assess for complications and questions. Cohorts of patients six months before and six months after implementation were assessed for main outcome measures. Before implementation, 55.5% of patients (427/769) who had one of the select surgical procedures were seen in the clinic postoperatively, and 62.6% (435/695) had a successful postoperative phone call follow-up. There were also 1090 overall scheduled postoperative appointments. Six months after implementation, overall postoperative appointments decreased 35.5% to 703. Overall, postoperative-scheduled visits decreased by 6% compared with new visits and other general follow-up visits, which each increased by 3%. A satisfaction survey revealed that 93% of patients (n = 231) were highly satisfied with the process. A hospital cost analysis suggested an 89% cost savings ($101.75 per patient for clinic visit vs $12.50 per patient for phone call follow-up). Postoperative phone call follow-up is an effective tool that improves patient and physician efficiency and satisfaction.

  6. Acromegalic patients lost to follow-up: a pilot study.

    Science.gov (United States)

    Kasuki, Leandro; Marques, Nelma Verônica; Nuez, Maria José Braga La; Leal, Vera Lucia Gomes; Chinen, Renata N; Gadelha, Mônica R

    2013-06-01

    Approximately 50 % of all acromegalic patients will require lifelong medical treatment to normalize mortality rates and reduce morbidity. Thus, adherence to therapy is essential to achieve treatment goals. To date, no study has evaluated the frequency and reasons for loss to follow-up in the acromegalic population. The current study aimed at evaluating the frequency of acromegalic patient loss to follow-up in three reference centers and the reasons responsible for their low compliance with treatment. All of the files for the acromegalic patients in the three centers were reviewed. Those patients, who had not followed up with the hospital for more than a year, were contacted via phone and/or mail and invited to participate. Patients who agreed to participate were interviewed, and blood samples were collected. A total of 239 files were reviewed; from these 42 patients (17.6 %) were identified who were lost to follow-up. It was possible to contact 27 of these patients, 10 of whom did not attend the appointments for more than one time and 17 of whom agreed to participate in the study. Fifteen of these 17 patients had active disease (88.2 %), and all of the patients restarted treatment in the original centers. The main reason for loss to follow-up was an absence of symptoms. High-quality follow-up is important in acromegaly to successfully achieve the aims of the treatment. An active search for patients may allow the resumption of treatment in a significant proportion of these cases, contributing to reduced morbidity and mortality in this patient population.

  7. Feasibility of telephone follow-up after medical abortion.

    Science.gov (United States)

    Perriera, Lisa K; Reeves, Matthew F; Chen, Beatrice A; Hohmann, Heather L; Hayes, Jennifer; Creinin, Mitchell D

    2010-02-01

    This study was conducted to assess the feasibility of using telephone calls combined with high-sensitivity urine pregnancy testing as a primary method of follow-up after medical abortion. We enrolled 139 women up to 63 days of gestation to receive mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, per their choice. Participants were contacted by phone one week after mifepristone administration and interviewed using standardized questions. If the subject or clinician thought the pregnancy was not expelled, the subject returned for an ultrasound examination. Otherwise, subjects performed high-sensitivity home urine pregnancy testing 30 days after the mifepristone and were called within 3 days of the test. Those with positive pregnancy tests returned for an ultrasound examination. Those with negative tests required no further follow-up. Six of the 139 (4.3%, 95% CI 1.6-9.1%) subjects presented prior to Phone Call 1 for an in-person visit. All 133 (100%, 95% CI 97.8-100%) subjects eligible for their first telephone follow-up were contacted. Eight of the 133 (6.1%, 95% CI 2.6-11.5%) women were asked to return for evaluation and all did so (100%, 95% CI 63.1-100%). Eight of the 133 women eligible for the 30 day phone call presented for an interim visit prior to the call. After 30 days, 116 of the 117 (99.1%, 95% CI 97.5-100%) eligible subjects were contacted. One subject was not reached for the day 30 phone call. Twenty-seven of the 116 (23.3%, 95% CI 15.6-31.0%) subjects had a positive pregnancy test and required follow-up. Two of these subjects (7.4%, 95% CI 1.0-24.2%) did not return for in-person follow-up. Two of the 116 (1.7%, 95% CI 0.2-6.1%) subjects had inconclusive pregnancy tests and were asked to return for follow-up. One of these subjects (50%, 95% CI 1.2-98.7%) did not return. Complete follow-up was achieved in 135 of the 139 subjects (97.1%, 95% CI 94.3-99.9%). None of the 26 women evaluated for a positive or inconclusive pregnancy

  8. Mitochondrial encephalomyopathy - two years follow-up by MRI

    Energy Technology Data Exchange (ETDEWEB)

    Hausegger, K.A.; Ebner, F.; Flueckiger, F.; Justich, E. (Graz Univ. (Austria). Radiologische Klinik); Millner, M.M. (Graz Univ. (Austria). Paediatrische Klinik)

    1991-04-01

    A case of mitochondrial encephalomyopathy (MEM) followed-up by MRI for 2 1/2 y is presented. MRI showed gross, diffusely distributed white matter lesions in both hemispheres predominantly in frontal, parietal, temporal and occipital locations a marked ventriculomegaly indicative of cerebral atrophy. Except a slight increase of the cerebral atrophy there were no changes in the follow-up examinations. There are no specific MRI findings in MEM, the diagnosis is established by the synopsis of MRI, laboratory data and muscle biopsy. (orig.).

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

    DEFF Research Database (Denmark)

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

    2012-01-01

    Barrett's Esophagus (BE) is a premalignant condition in the esophagus. Esophageal adenocarcinomas have the fastest increase of incidence of all solid tumors in the western world. BE is defined as areas with macroscopic visible columnar epithelium and intestinal metaplasia oral of the anatomical...... 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...

  10. 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.

  11. Three-year follow-up of bibliotherapy for depression.

    Science.gov (United States)

    Smith, N M; Floyd, M R; Scogin, F; Jamison, C S

    1997-04-01

    This study examined the durability of cognitive bibliotherapy for mild to moderately depressed adults by conducting a 3-year follow-up of participants from a previous study (C. Jamison & F. Scogin, 1995). The Hamilton Rating Scale for Depression, Beck Depression Inventory, and questions relating to participants' perceptions of the program were administered. Results indicated that treatment gains were maintained over the 3-year follow-up period and support the usefulness of cognitive bibliotherapy as an adjunct to traditional treatment modalities in a general adult population.

  12. 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)

  13. Adjunctive rufinamide in Lennox-Gastaut syndrome: a long-term, open-label extension study.

    Science.gov (United States)

    Kluger, G; Glauser, T; Krauss, G; Seeruthun, R; Perdomo, C; Arroyo, S

    2010-09-01

    This open-label extension evaluated the long-term efficacy and tolerability of rufinamide in patients with Lennox-Gastaut syndrome (LGS) who had previously completed a 12-week double-blind study. In total, 124 patients (aged 4-37 years), receiving 1-3 concomitant antiepileptic drugs, were treated with rufinamide approximately 25-60 mg/kg/day. Efficacy was assessed by seizure frequency; tolerability by adverse events (AEs) and laboratory tests. Overall, patients were treated with rufinamide for a median (range) of 432 (10-1149) days. Reductions in seizure frequency were observed throughout the study; during the last 12 months of treatment, 41.0% and 47.9% of patients had > or = 50% reduction in total and tonic-atonic seizure frequency, respectively. The most common AEs were vomiting (30.6%) and pyrexia (25.8%). In this open-label extension, rufinamide appeared to be an effective long-term adjunctive therapy for the treatment of LGS-associated seizures in children and young adults.

  14. Is DRE essential for the follow up of prostate cancer patients? A prospective audit of 194 patients

    Directory of Open Access Journals (Sweden)

    Matanhelia Shyam S

    2005-01-01

    Full Text Available Abstract Background Prostate cancer follow up forms a substantial part of the urology outpatient workload. Nurse led prostate cancer follow up clinics are becoming more common. Routine follow-up may involve performing DRE, which may require training. Objectives The aim of this audit was to assess the factors that influenced the change in the management of prostate cancer patients during follow up. This would allow us to pave the way towards a protocol driven follow up clinic led by nurse specialists without formal training in DRE. Results 194 prostate cancer patients were seen over a period of two months and all the patients had DRE performed on at least one occasion. The management was changed in 47 patients. The most common factor influencing this change was PSA trend. A change in DRE findings influenced advancement of the clinic visit in 2 patients. Conclusions PSA is the most common factor influencing change in the management of these patients. Nurse specialists can run prostate cancer follow-up clinics in parallel to existing consultant clinics and reserve DRE only for those patients who have a PSA change or have onset of new symptoms. However larger studies are required involving all the subgroups of patients to identify the subgroups of patients who will require DRE routinely.

  15. The Minnesota Couple Communication Program: A Follow-Up Study.

    Science.gov (United States)

    Wampler, Karen Smith; Sprenkle, Douglas H.

    1980-01-01

    The Minnesota Couple Communication Program had a positive effect on the couple's use of open-style communication and on perceived quality of the couple's relationship immediately after training. Only the positive changes in perceived quality of relationship persisted at the follow-up. (Author)

  16. 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...

  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. A Follow-Up Study of Former Student Health Advocates

    Science.gov (United States)

    Streng, Nancy J.

    2007-01-01

    Student health advocates (SHAs) are high school students who, under the supervision of the school nurse, provide health education and health promotion activities to other students via a peer education model. This 3-year follow-up study explored how the SHA experience influences career choice and attitudes of the participants. It also examined what…

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

    Energy Technology Data Exchange (ETDEWEB)

    Uder, Michael; Gohl, Dietrich; Takahashi, Masahide; Kramann, Bernhard; Schneider, Guenther [Universitaet des Saarlandes, Homburg/Saar (Germany). Radiologische Klinik; Derouet, Harry [Universitaet des Saarlandes, Homburg/Saar (Germany). Urologische Klinik; Defreyne, Luc [Department of Radiology and Medical Imaging, University Hospital of Gent (Belgium)

    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.)

  20. Follow-up photometry of iPTF16geu

    Science.gov (United States)

    Lee, C.-H.

    2016-10-01

    We report follow-up photometry of the strongly lensed SNIa iPTF16geu (ATel #9603, #9626). We observed iPTF16geu on 2016/10/17 with the 2.5-m Isaac Newton Telescope (INT) + WFC at La Palma, under ~0.9" seeing condition.

  1. A Follow-Up Study of Dyslexic Boys.

    Science.gov (United States)

    Finucci, Joan M.; And Others

    1985-01-01

    Over 500 men who attended an independent school for children with developmental dyslexia were followed up from one to 38 years after they left the school. Socioeconomic status and IQ were not predictive of adult outcome. Severity of reading problem upon entrance and academic and remedial progress while at school were predictive of adult…

  2. 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.

  3. Transient Alert Follow-up Planned for CCAT

    CERN Document Server

    Jenness, Tim

    2014-01-01

    CCAT is a sub-millimeter telescope to be built on Cerro Chajnantor in Chile near the ALMA site. The remote location means that all observing will be done by remote observers with the future goal of fully autonomous observing using a dynamic scheduler. The fully autonomous observing mode provides a natural means for accepting transient alert notifications for immediate follow up.

  4. Magnetic Resonance Imaging in Follow-up Assessment of Sciatica

    NARCIS (Netherlands)

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

    2013-01-01

    BACKGROUND 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. METHODS We studied 283 patients in a randomized trial

  5. Treatment, follow-up and microbiota in acute diverticulitis

    NARCIS (Netherlands)

    Daniels, L.

    2015-01-01

    Er bestaat veel controverse rondom diverticulitis. Er is tegenstrijdigheid omtrent de beste behandeling van de verschillende stadia. Voor acute ongecompliceerde diverticulitis is het onzeker of antibiotica nodig zijn. De waarde van routine follow-up colonoscopie wordt betwijfeld. Er bestaat onduidel

  6. A Follow-up Study of Secretarial Students.

    Science.gov (United States)

    Gell, Robert L.; Bleil, David F.

    To determine how effectively the Secretarial Studies Department's program was meeting the needs of its students, a follow-up study was conducted of former Montgomery Community College Secretarial Studies students. The survey sought to determine, in particular, if the students had secured employment that was related to their course work at the…

  7. 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…

  8. 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.

  9. Morning Star Cycle Two: Follow-up Study.

    Science.gov (United States)

    Sloan, L. V.

    Semi-structured telephone interviews were used to gather follow-up data on students who completed the 1977-1979 Morning Star cycle two program, a community-based Native teacher education program at the Blue Quills Native Education Centre leading to a Bachelor of Education degree from the University of Alberta. Of the 24 students who completed…

  10. 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...

  11. 49 CFR 219.211 - Analysis and follow-up.

    Science.gov (United States)

    2010-10-01

    ...-accident toxicological testing under this subpart are reported to the railroad's Medical Review Officer and... Medical Review Officer may not disclose to FRA the underlying physical condition for which any medication... 49 Transportation 4 2010-10-01 2010-10-01 false Analysis and follow-up. 219.211 Section 219.211...

  12. Outpatient follow-up after traumatic injury: Challenges and opportunities

    Directory of Open Access Journals (Sweden)

    Luke Hansen

    2014-01-01

    Full Text Available Background: It has been shown that rates of ambulatory follow-up after traumatic injury are not optimal, but the association with insurance status has not been studied. Aims: To describe trauma patient characteristics associated with completed follow-up after hospitalization and to compare relative rates of healthcare utilization across payor types. Setting and Design: Single institution retrospective cohort study. Materials and Methods: We compared patient demographics and healthcare utilization behavior after discharge among trauma patients between April 1, 2005 and April 1, 2010. Our primary outcome of interest was outpatient provider contact within 2 months of discharge. Statistical Analysis: Multivariate logistic regression was used to determine the association between characteristics including insurance status and subsequent ambulatory and acute care. Results: We reviewed the records of 2906 sequential trauma patients. Patients with Medicaid and those without insurance were significantly less likely to complete scheduled outpatient follow-up within 2 months, compared to those with private insurance (Medicaid, OR 0.67, 95% CI 0.51-0.88; uninsured, OR 0.29, 95% CI 0.23-0.36. Uninsured and Medicaid patients were twice as likely as privately insured patients to visit the Emergency Department (ED for any reason after discharge (uninsured patients (Medicaid, OR 2.6, 95% CI 1.50-4.53; uninsured, OR 2.10, 94% CI 1.31-3.36. Conclusion: We found marked differences between patients in scheduled outpatient follow-up and ED utilization after injury associated with insurance status; however, Medicaid seemed to obviate some of this disparity. Medicaid expansion may improve outpatient follow-up and affect patient outcome disparities after injury.

  13. Duloxetine in the treatment of major depressive disorder: an open-label study

    Directory of Open Access Journals (Sweden)

    Wang Fujun

    2007-08-01

    Full Text Available Abstract Background Major depressive disorder (MDD is a chronic and highly disabling condition. Existing pharmacotherapies produce full remission in only 30% to 40% of treated patients. Antidepressants exhibiting dual reuptake inhibition of both serotonin (5-HT and norepinephrine (NE may achieve higher rates of remission compared with those acting upon a single neurotransmitter. In this study, the safety and efficacy of duloxetine, a potent dual reuptake inhibitor of 5-HT and NE, were examined. Methods Patients (N = 533 meeting DSM-IV criteria for MDD received open-label duloxetine (60 mg once a day [QD] for 12 weeks during the initial phase of a relapse prevention trial. Patients were required to have a 17-item Hamilton Rating Scale for Depression (HAMD17 total score ≥18 and a Clinical Global Impression of Severity (CGI-S score ≥4 at baseline. Efficacy measures included the HAMD17 total score, HAMD17 subscales, the CGI-S, the Patient Global Impression of Improvement (PGI-I scale, Visual Analog Scales (VAS for pain, and the Symptom Questionnaire, Somatic Subscale (SQ-SS. Quality of life was assessed using the Sheehan Disability Scale (SDS and the Quality of Life in Depression Scale (QLDS. Safety was evaluated by recording spontaneously-reported treatment-emergent adverse events, changes in vital signs and laboratory analytes, and the Patient Global Impression of Sexual Function (PGI-SF scale. Results The rate of discontinuation due to adverse events was 11.3%. Treatment-emergent adverse events reported by ≥10% duloxetine-treated patients were nausea, headache, dry mouth, somnolence, insomnia, and dizziness. Following 12 weeks of open-label duloxetine therapy, significant improvements were observed in all assessed efficacy and quality of life measures. In assessments of depression severity (HAMD17, CGI-S the magnitude of symptom improvement continued to increase at each study visit, while for painful physical symptoms the onset of

  14. KLENOT Project - Near Earth Objects Follow-up Program

    Science.gov (United States)

    Tichy, Milos; Ticha, Jana; Kocer, Michal; Tichy, Milos

    2015-08-01

    Near Earth Object (NEO) research is important not only as a great challenge for science but also as an important challenge for planetary defense. Therefore NEO discoveries, astrometric follow-up, orbit computations as well as physical studies are of high interest both to science community and humankind.The KLENOT Project of the Klet Observatory, South Bohemia, Czech Republic pursued the confirmation, early follow-up, long-arc follow-up and recovery of NEOs since 2002. Tens of thousands astrometric measurements helped to make inventory of NEOs as well as to understand the NEO distribution. It ranked among the world most prolific professional NEO follow-up programmes during its first phase from 2002 to 2008.The fundamental improvement of the 1.06-m KLENOT Telescope was started in autumn 2008. The new computer controlled paralactic mount was built to substantially increase telescope-time efficiency, the number of observations, their accuracy and limiting magnitude. The testing observations of the KLENOT Telescope Next Generation were started in October 2011. The new more efficient CCD camera FLI ProLine 230 was installed in summer 2013.The original Klet Software Package has been continually upgraded over the past two decades of operation.Both the system and strategy for the NEO follow-up observation used in the framework of the KLENOT Project are described here, including methods for selecting useful and important targets for NEO follow-up astrometry.The modernized KLENOT System was put into full operation in September 2013. More than 8000 of minor planet and comet astrometric positions including NEA measurements were published from September 2013 to February 2015.The 1.06-m KLENOT telescope is still the largest telescope in continental Europe used exclusively for observations of asteroids and comets. Full observing time is dedicated to the KLENOT team. Considering our results and long-time experience obtained at the Klet Observatory, we have the large potential to

  15. 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-AFrandomised 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 months

  16. Long-term follow-up of congenital diaphragmatic hernia.

    Science.gov (United States)

    Hollinger, Laura E; Harting, Matthew T; Lally, Kevin P

    2017-06-01

    Increased survival of patients with congenital diaphragmatic hernia has created a unique cohort of children, adolescent, and adult survivors with complex medical and surgical needs. Disease-specific morbidities offer the opportunity for multiple disciplines to unite together to provide long-term comprehensive follow-up, as well as an opportunity for research regarding late outcomes. These children can exhibit impaired pulmonary function, altered neurodevelopmental outcomes, nutritional insufficiency, musculoskeletal changes, and specialized surgical needs that benefit from regular monitoring and intervention, particularly in patients with increased disease severity. Below we aim to characterize the specific challenges that these survivors face as well as present an algorithm for a multidisciplinary long-term follow-up program. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. 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.

  18. Improving Lunar Exploration with Robotic Follow-up

    Science.gov (United States)

    Fong, T.; Bualat, M.; Deans, M.; Heggy E.; Helper, M.; Hodges, K.; Lee, P.

    2011-01-01

    We are investigating how augmenting human field work with subsequent robot activity can improve lunar exploration. Robotic "follow-up" might involve: completing geology observations; making tedious or long-duration measurements of a target site or feature; curating samples in-situ; and performing unskilled, labor-intensive work. To study this technique, we have begun conducting a series of lunar analog field tests at Haughton Crater (Canada). Motivation: In most field geology studies on Earth, explorers often find themselves left with a set of observations they would have liked to make, or samples they would have liked to take, if only they had been able to stay longer in the field. For planetary field geology, we can imagine mobile robots - perhaps teleoperated vehicles previously used for manned exploration or dedicated planetary rovers - being deployed to perform such follow-up activities [1].

  19. Trismus-pseudocamptodactyly syndrome: a 20 year follow-up.

    Science.gov (United States)

    Marianetti, T M; Dall'Asta, L; Torroni, A; Gasparini, G; Pelo, S

    2014-07-01

    Trismus-Pseudocamptodactyly Syndrome (TPS) is a rare autosomal syndrome characterised by the inability to open the mouth fully, pseudocamptodactyly, short stature and foot deformities. The maxillofacial feature entails hyperplasia of the coronoid processes which mechanically interfere with the zygomatic processes during mouth opening. A 22-year- old girl affected by a severe form of TPS was followed from the age of three years. Bone reossification was observed after two coronoidotomies of both hyperplasic coronoid processes. After the decision to perform a coronoidectomy, the four-year follow-up showed a favourable outcome. Meanwhile the patient developed an anterior open bite which was treated with a fourth orthognathic surgery. The follow-up underscores how the correction of malformation leads to the generation of EMG activity of the masticatory muscles after many years of passiveness.

  20. Is follow-up capacity the current NHS bottleneck?

    Science.gov (United States)

    Allder, Steven; Walley, Paul; Silvester, Kate

    2011-02-01

    Capacity and demand theory suggests that the presence of a queue is not necessarily an indication of a shortage of capacity in a system. It is much more likely that either there is a demand and capacity variation that creates queues or there is a delay designed into the system. A shortage of capacity is only really indicated where a backlog is not stable and continues to grow. In this article, data are taken from one NHS trust that provides evidence for a continually growing backlog for follow-up outpatient services. It is believed that these data are representative of most locations within the NHS in England and therefore suggest an immediate shortage in effective follow-up capacity. To avoid compromise to patient care, the problem will have to be addressed before the situation becomes unmanageable. The paper highlights options to reduce or deflect demand or to increase effective capacity.

  1. [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.

  2. The Safe Dates program: 1-year follow-up results.

    Science.gov (United States)

    Foshee, V A; Bauman, K E; Greene, W F; Koch, G G; Linder, G F; MacDougall, J E

    2000-01-01

    OBJECTIVES: An earlier report described desirable 1-month follow-up effects of the Safe Dates program on psychological, physical, and sexual dating violence. Mediators of the program-behavior relationship also were identified. The present report describes the 1-year follow-up effects of the Safe Dates program. METHODS: Fourteen schools were in the randomized experiment. Data were gathered by questionnaires in schools before program activities and 1 year after the program ended. RESULTS: The short-term behavioral effects had disappeared at 1 year, but effects on mediating variables such as dating violence norms, conflict management skills, and awareness of community services for dating violence were maintained. CONCLUSIONS: The findings are considered in the context of why program effects might have decayed and the possible role of boosters for effect maintenance. PMID:11029999

  3. A randomized, open-label pilot comparison of gabapentin and bupropion SR for smoking cessation.

    Science.gov (United States)

    White, William D; Crockford, David; Patten, Scott; El-Guebaly, Nady

    2005-10-01

    This 6-week, randomized, open-label pilot study estimated the treatment effect size of gabapentin (n = 17) compared with bupropion SR (n = 19) for smoking cessation, thereby allowing sample size calculations for a definitive comparison study. The primary outcome measure was smoking cessation. Secondary outcome measures included smoking reduction and withdrawal severity. Gabapentin was less efficacious than bupropion for smoking cessation but was associated with fewer dropouts from adverse effects. Withdrawal severity was less with bupropion. Bupropion remains the first-line non-nicotine pharmacotherapy for smoking cessation. Further study is required to determine if gabapentin has any useful role in smoking cessation. Based on our primary outcome measure, 79 subjects would be required in each treatment group of a two-armed study to achieve 90% power for detecting a difference in efficacy between gabapentin and bupropion.

  4. An open-label pilot study of infliximab therapy in diffuse cutaneous systemic sclerosis

    DEFF Research Database (Denmark)

    Denton, C P; Engelhart, M; Tvede, N

    2008-01-01

    AIM: The safety and potential efficacy of a chimaeric anti-tumour necrosis factor alpha monoclonal antibody (infliximab) were examined in diffuse cutaneous systemic sclerosis (dcSSc). METHODS: A 26-week open-label pilot study in which 16 cases of dcSSc received five infusions of infliximab (5 mg...... of type I collagen by dermal fibroblasts was reduced at 26 weeks compared with baseline (p = 0.02). There were no deaths during the study and no suspected unexpected serious adverse reactions. 21 serious adverse events (AE) occurred in seven subjects, mostly attributable to dcSSc. 127 distinct AE occurred...... in 16 subjects. Of these, 19 AE (15%) were probably or definitely related to infliximab treatment. Eight (50%) patients prematurely discontinued infliximab. Anti-infliximab antibodies developed during the study in five subjects and were significantly associated with suspected infusion reactions (p = 0...

  5. EMCS Installation Follow-Up Study. Volume 2.

    Science.gov (United States)

    1984-03-01

    were in progress at the time of this site visit. A post occupancy evaluation (POE) was performed on August 9 & 10. Copies of three documents related to...FOLLOW-UP INVESTIGATION SITE VISIT ATTACHMENTS I. Norfolk Naval Shipyard - Post Occupancy Evaluation Field 1 Notes 2. Norfolk Naval Shipyard - Additional... Post Occupancy Evaluation Comments 3. Norfolk Naval Shipyard - Post Occupancy Evaluation Station Comments 4. Langley Air Force Base - F-i. F-2 POST

  6. Serial extraction: 20 years of follow-up

    OpenAIRE

    Renato Rodrigues de Almeida; Marcio Rodrigues de Almeida; Paula Vanessa Pedron Oltramari-Navarro; Ana Cláudia de Castro Ferreira Conti; Ricardo de Lima Navarro; Karen Regina Siqueira de Souza

    2012-01-01

    This paper reports a case treated by a serial extraction program at the mixed dentition stage followed by a corrective orthodontic treatment, with a long-term follow-up period. Twenty years after the interceptive treatment, a harmonious face was observed along with treatment stability in the anterior posterior direction, deep overbite (which has been mentioned as a disadvantage of the serial extraction program), and a small relapse of anterior tooth crowding. All these conditions have been re...

  7. Alberta Euthanasia Survey: 3-year follow-up.

    Science.gov (United States)

    Verhoef, M J; Kinsella, T D

    1996-01-01

    OBJECTIVE: To determine whether the opinions of Alberta physicians about active euthanasia had changed and to assess the determinants of potential changes in opinion. DESIGN: Follow-up survey (mailed questionnaire) of physicians included in the 1991 Alberta Euthanasia Survey. SETTING: Alberta. PARTICIPANTS: Of the 1391 physicians who participated in the 1991 survey 1291 (93%) had indicated that they were willing to take part in a follow-up survey. A follow-up questionnaire was mailed in 1994 to 1146 physicians who could be traced through the 1994 Medical Directory of the provincial college of physicians and surgeons; 25 questionnaires were returned because they could not be delivered. OUTCOME MEASURES: Physicians' opinions about (a) the morality of active euthanasia, (b) changes in the law to permit active euthanasia and (c) the practice of legalized euthanasia. RESULTS: Of the 1121 physicians sent a follow-up questionnaire 866 (77%) returned it completed. The responses of these same 866 physicians in 1991 provided a basis for comparison. Of the 866, 360 (42%) stated in the 1994 survey that it is sometimes right to practise active euthanasia; a similar proportion (384 [44%]) gave this response in 1991. However, other opinions changed significantly. In 1991, 250 of the respondents (29%) indicated that they would practise active euthanasia if it were legalized, as compared with 128 (15%) in 1994 (p euthanasia, as compared with 316 (37%) in 1994 (p euthanasia between 1991 and 1994, in both surveys at least 70% of those who responded to this question indicated that active euthanasia, if it were legalized, should be performed only by physicians and should be taught at medical sites. CONCLUSION: Alberta physicians' support for the practice and legalization of active euthanasia decreased considerably between 1991 and 1994. However, most physicians remain in favour of restricting active euthanasia, if it were legalized, to the medical profession. These results suggest a

  8. [Renal lithiasis. Biochemical changes in the follow-up].

    Science.gov (United States)

    Spivacow, Francisco R; del Valle, Elisa E; Zancheta, José R

    2006-01-01

    With the aim of assessing if biochemical changes occur in the follow up of patients with renal lithiasis, 237 patients were studied (115 women and 122 men, mean age 39 +/- 8 and 42 +/- 7 years, respectively) and controlled during 27.3 +/- 19.3 months. All of them had previously undergone metabolic evaluations at baseline and one or more than one control studies afterwards. Patients with a diagnosis of sponge kidney, renal tubular acidosis, primary hyperparathyroidism, anatomical malformations of the urinary tract, or urinary infections were not included. Two populations were identified: those who presented changes in the baseline diagnosis (139 patients, Group I) and those who presented no changes (98 patients, Group II). In these groups, no differences were observed in baseline metabolic diagnoses or in the follow-up period. Hypocitraturia was the additional diagnosis most frequently observed (43.1%), followed by Idiopatic hypercalciuria (20.8%) and abnormalities of uric acid (16.5%). In the group of 110 patients followed up for more than 3 years, 37 patients recurred (33%). Among the latter, 25 (23%) changed the baseline metabolic diagnosis vs. 12 (11%) that maintained the same diagnosis (p < 0.002). Changes in metabolic disorders were frequently observed in the follow up of patients with nephrolithiasis. These changes are not necessarily associated with the diet indicated or drug treatment. Hypocitraturia was the additional metabolic disorder most frequently found. In general, there is a higher recurrence rate in those patients who present changes in their biochemical parameters and undergo no treatment.

  9. A Follow-Up Study of 69 Discharged SARS Patients

    Institute of Scientific and Technical Information of China (English)

    韩云; 庚慧; 冯维斌; 汤湘江; 欧爱华; 老膺荣; 许银姬; 林浩; 刘惠; 李咏文

    2003-01-01

    @@ Sixty-nine patients with severe acute respiratory syndrome (SARS) discharged from Guangdong Provincial TCM Hospital were followed up from January to April 2003 during which the patients were asked to fill the questionnaire form and at the same time received blood routine examination, hepatic, renal,pulmonary and immune function tests, and spiral computerized tomography (CT) of the chest, color Bultrasonography of the heart with the collected data treated by descriptive analysis and deductive analysis.

  10. 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…

  11. Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations.

    Science.gov (United States)

    Blease, Charlotte; Colloca, Luana; Kaptchuk, Ted J

    2016-07-01

    The doctor-patient relationship is built on an implicit covenant of trust, yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically.

  12. A prospective open-label trial of lamotrigine monotherapy in children and adolescents with bipolar disorder.

    Science.gov (United States)

    Biederman, Joseph; Joshi, Gagan; Mick, Eric; Doyle, Robert; Georgiopoulos, Anna; Hammerness, Paul; Kotarski, Meghan; Williams, Courtney; Wozniak, Janet

    2010-04-01

    To evaluate the safety and efficacy of lamotrigine monotherapy as an acute treatment of bipolar mood elevation in children with bipolar spectrum disorders. This was a 12-week, open-label, prospective trial of lamotrigine monotherapy to assess the effectiveness and tolerability of this compound in treating pediatric bipolar disorder. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale (CGI-I), Children's Depression Rating Scale (CDRS), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs weight monitoring, and laboratory analysis. Thirty-nine children with bipolar disorder (YMRS at entry: 31.6 +/- 5.5) were enrolled in the study and 22 (56%) completed the 12-week trial. Lamotrigine was slowly titrated to an average endpoint dose of 160.7 +/- 128.3 in subjects children 12-17 years of age (N = 17). Treatment with lamotrigine was associated with statistically significant levels of improvement in mean YMRS scores (-14.9 +/- 9.7, P disorder (ADHD), and psychotic symptoms. Lamotrigine was generally well tolerated with marginal increase in body weight (47.0 +/- 18.0 kg vs. 47.2 +/- 17.9 kg, P= 0.6) and was not associated with abnormal changes in laboratory parameters. Several participants were discontinued due to skin rash; in all cases, the rash resolved shortly after discontinuation of treatment. No patient developed Steven Johnson syndrome. Open-label lamotrigine treatment appears to be beneficial in the treatment of bipolar disorder and associated conditions in children. Future placebo-controlled, double-blind studies are warranted to confirm these findings.

  13. Paediatrician office follow-up of common minor fractures

    Science.gov (United States)

    Koelink, Eric; Boutis, Kathy

    2014-01-01

    BACKGROUND: Evidence suggests that minor paediatric fractures can be followed by primary care paediatricians (PCPs). OBJECTIVES: To determine PCP opinions, knowledge and perceived barriers to managing minor paediatric fractures in the office. METHODS: An online survey was sent between June and September 2013 to all paediatricians who subscribed to the American Academy of Pediatrics PROS-Net Listerv and to those who were registered with the Scott’s Canadian Medical Directory as paediatricians who treated children in a primary care capacity. The primary outcome was the proportion of PCPs who agreed with PCP follow-up of minor paediatric fractures. Secondary outcomes included PCP’s perceived barriers to office follow-up. RESULTS: A total of 1752 surveys were sent; 1235 were eligible and 459 (37.2%) responded to the survey. Overall, 296 (69.5% [95% CI 65.2% to 74.0%]) PCPs agreed that minor paediatric fractures could be followed in a PCP office. The most frequently reported barriers were lack of materials to replace immobilization (58.1%), PCP knowledge deficits (44.8%) and a perceived parental preference for an orthopedic surgeon (38.6%). Finally, 58.8% of respondents believed that further education was necessary if PCPs assumed responsibility for follow-up of midshaft clavicle fractures, while 66.5% and 77.1% (Pmanagement strategy, including a desire for more education on this topic. PMID:25382996

  14. Investigating follow-up outcome change using hierarchical linear modeling.

    Science.gov (United States)

    Ogrodniczuk, J S; Piper, W E; Joyce, A S

    2001-03-01

    Individual change in outcome during a one-year follow-up period for 98 patients who received either interpretive or supportive psychotherapy was examined using hierarchical linear modeling (HLM). This followed a previous study that had investigated average (treatment condition) change during follow-up using traditional methods of data analysis (repeated measures ANOVA, chi-square tests). We also investigated whether two patient personality characteristics-quality of object relations (QOR) and psychological mindedness (PM)-predicted individual change. HLM procedures yielded findings that were not detected using traditional methods of data analysis. New findings indicated that the rate of individual change in outcome during follow-up varied significantly among the patients. QOR was directly related to favorable individual change for supportive therapy patients, but not for patients who received interpretive therapy. The findings have implications for determining which patients will show long-term benefit following short-term supportive therapy and how to enhance it. The study also found significant associations between QOR and final outcome level.

  15. 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.

  16. Follow-up after treatment for breast cancer

    Science.gov (United States)

    Sisler, Jeffrey; Chaput, Genevieve; Sussman, Jonathan; Ozokwelu, Emmanuel

    2016-01-01

    Objective To offer FPs a summary of evidence-based recommendations to guide their follow-up survivorship care of women treated for breast cancer. Quality of evidence A literature search was conducted in MEDLINE from 2000 to 2016 using the search words breast cancer, survivorship, follow-up care, aftercare, guidelines, and survivorship care plans, with a focus on review of recent guidelines published by national cancer organizations. Evidence ranges from level I to level III. Main message Survivorship care involves 4 main tasks: surveillance and screening, management of long-term effects, health promotion, and care coordination. Surveillance for recurrence involves only annual mammography, and screening for other cancers should be done according to population guidelines. Management of the long-term effects of cancer and its treatment addresses common issues of pain, fatigue, lymphedema, distress, and medication side effects, as well as longer-term concerns for cardiac and bone health. Health promotion emphasizes the benefits of active lifestyle change in cancer survivors, with an emphasis on physical activity. Survivorship care is enhanced by the involvement of various health professionals and services, and FPs play an important role in care coordination. Conclusion Family physicians are increasingly the main providers of follow-up care after breast cancer treatment. Breast cancer should be viewed as a chronic medical condition even in women who remain disease free, and patients benefit from the approach afforded other chronic conditions in primary care. PMID:27737976

  17. 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

  18. 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

  19. Open-label, multicentre safety study of vemurafenib in 3219 patients with BRAF(V600) mutation-positive metastatic melanoma : 2-year follow-up data and long-term responders' analysis

    NARCIS (Netherlands)

    Blank, Christian U.; Larkin, James E.; Arance, Ana M.; Hauschild, Axel; Queirolo, Paola; Del Vecchio, Michele; Ascierto, Paolo A.; Krajsova, Ivana; Schachter, Jacob; Neyns, Bart; Garbe, Claus; Sileni, Vanna Chiarion; Mandala, Mario; Gogas, Helen; Espinosa, Enrique; Hospers, Geke A. P.; Miller, Wilson H.; Robson, Susan; Makrutzki, Martina; Antic, Vladan; Brown, Michael P.

    2017-01-01

    Background: The orally available BRAF kinase inhibitor vemurafenib is an effective and tolerable treatment option for patients with metastatic melanoma harbouring BRAF(V600) mutations. We assessed the safety of vemurafenib in a large population of patients with few alternative treatment options; we

  20. 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

  1. Colonic resection for colovesical fistula: 5-year follow-up.

    Science.gov (United States)

    Walker, K. G; Anderson, J. H; Iskander, N; McKee, R. F; Finlay, I. G

    2002-07-01

    OBJECTIVES: The outcome of colovesical fistula management may be unsatisfactory; complications are reported in up to 45% of patients. Published studies are retrospective and tend to lack standardized management strategies and long-term follow-up. This cohort study assesses a policy of resection of colovesical fistulae in continuity with any distal colorectal stricture, and includes 5-year follow-up. METHOD: All patients undergoing surgery in our institution for colovesical fistula between February 1991 and April 1995 were entered into the study. The fistulae were resected in continuity with any distal bowel stricture, according to a standard single-stage operative protocol. Postoperative mortality and morbidity were recorded, and prospective review was undertaken at April 2000. RESULTS: Nineteen consecutive patients entered the study. The source of the fistula was diverticular disease (n = 14), colorectal cancer (n = 3), trauma (n = 1) or Crohn's (n = 1) disease. Thirteen patients had a colorectal stricture. One patient died due to ischaemic colitis within 30 days of surgery. Eleven other patients died of unrelated causes before April 2000, in whom there was no evidence of fistula recurrence before death at a median of 37 months after operation (range 2-95 months). At 5-year follow-up there was no evidence of fistula recurrence in the seven remaining patients. CONCLUSIONS: A policy of resection of the fistula and associated colorectal stricture with primary bowel anastomosis and bladder drainage, resulted in no recurrences and low morbidity. However comorbidity is important in this patient population, most of whom will die from unrelated causes within a few years.

  2. Education On Prehospital Pain Management: A Follow-Up Study

    Directory of Open Access Journals (Sweden)

    Scott C. French

    2013-03-01

    Full Text Available Introduction: The most common reason patients seek medical attention is pain. However,there may be significant delays in initiating prehospital pain therapy. In a 2001 qualityimprovement (QI study, we demonstrated improvement in paramedic knowledge,perceptions, and management of pain. This follow-up study examines the impact of thisQI program, repeated educational intervention (EI, and effectiveness of a new painmanagement standard operating procedure.Methods: 176 paramedics from 10 urban and suburban fire departments and two privateambulance services participated in a 3-hour EI. A survey was performed prior to the EI andrepeated one month after the EI. We reviewed emergency medical services (EMS runs withpain complaints prior to the EI and one month after the EI. Follow-up results were comparedto our prior study. We performed data analysis using descriptive statistics and chi-square tests.Results: The authors reviewed 352 surveys and 438 EMS runs with pain complaints. Usingthe same survey questions, even before the EI, 2007 paramedics demonstrated significantimprovement in the knowledge (18.2%; 95% CI 8.9%, 27.9%, perceptions (9.2%; 95% CI6.5%, 11.9%, and management of pain (13.8%; 95% CI 11.3%, 16.2% compared to 2001.Following EI in 2007, there were no significant improvements in the baseline knowledge (0%;95% CI 5.3%, 5.3% but significant improvements in the perceptions of pain principles (6.4%;95% CI 3.9%, 9.0% and the management of pain (14.7%; 95% CI 11.4%, 18.0%.Conclusion: In this follow up study, paramedics’ baseline knowledge, perceptions, andmanagement of pain have all improved from 6 years ago. Following a repeat educationalintervention, paramedics further improved their field management of pain suggestingparamedics will still benefit from both initial and also ongoing continuing education on thetopic of pain management.

  3. Cervical disc prosthesis: 2-year follow-up

    Directory of Open Access Journals (Sweden)

    Romero Pinto de Oliveira Bilhar

    2015-06-01

    Full Text Available OBJECTIVE: To review the medical records of patients who underwent surgery for placement of cervical disc prosthesis after two years of postoperative follow-up, showing the basic epidemiological data, the technical aspects and the incidence of complications.METHODS: Medical records of seven patients who underwent surgery for placement of cervical disc prosthesis were reviewed after two years of follow-up, at the Institute of Orthopedics and Traumatology, Faculty of Medicine, University of São Paulo.RESULTS: The average age of patients participating in this study was 43.86 years. Six patients (85.7% had one level approached while one patient (14.3% had two levels addressed. The level C5-C6 has been approached in one patient (14.3% while the C6-C7 level was addressed in five patients (71.4%. One patient (14.3% had these two levels being addressed, C5-C6 and C6-C7. The mean operative time was 164.29±40 minutes. Three patients were hospitalized for 2 days and four for 3 days making an average of 2.57±0.535 days. Two patients (28.6% underwent a new surgical intervention due to loosening of the prosthesis. The mean follow-up was 28.14±5.178 months (23-35 months.CONCLUSIONS: Although cervical arthroplasty appears to be a safe procedure and present promising results in our study as well as in many other studies, it requires long-term studies.

  4. 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

  5. Klenot Project - Near Earth Objects Follow-Up Program

    Science.gov (United States)

    Tichý, Miloš; Tichá, Jana; Kočer, Michal

    2016-01-01

    NEO research is a great challenge just now - for science, for exploration and for planetary defence. Therefore NEO discoveries, astrometric follow-up, orbit computations as well as physical studies are of high interest both to science community and humankind. The KLENOT Project of the Klet Observatory, South Bohemia, Czech Republic pursued the confirmation, early follow-up, long-arc follow-up and recovery of Near Earth Objects since 2002. Tens of thousands astrometric measurements helped to make inventory of NEOs as well as to understand the NEO population. It ranked among the world most prolific professional NEO follow-up programmes during its first phase from 2002 to 2008. The fundamental improvement of the 1.06-m KLENOT Telescope was started in autumn 2008. The new computer controlled paralactic mount was built to substantially increase telescope-time efficiency, the number of observations, their accuracy and limiting magnitude. The testing observations of the KLENOT Telescope Next Generation (NG) were started in October 2011. The new more efficient CCD camera FLI ProLine 230 was installed in summer 2013. The original Klet Software Package has been continually upgraded over the past two decades of operation. Along with huge hardware changes we have decided for essential changes in software and the whole KLENOT work-flow. Using the current higher computing power available, enhancing and updating our databases and astrometry program, the core of our software package, will prove highly beneficial. Moreover, the UCAC4 as the more precise astrometric star catalog was implemented. The modernized KLENOT System was put into full operation in September 2013. This step opens new possibilities for the KLENOT Project, the long-term European Contribution to Monitoring and Cataloging Near Earth Objects. KLENOT Project Goals are confirmatory observations of newly discovered fainter NEO candidates, early follow-up of newly discovered NEOs, long-arc follow-up astrometry of NEOs

  6. GRBs Optical follow-up observation at Lulin observatory, Taiwan

    CERN Document Server

    Huang, K Y; Ip, W H; Tamagawa, T; Onda, K; Makishima, K

    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.

  7. 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.

  8. Serial extraction: 20 years of follow-up

    Science.gov (United States)

    de ALMEIDA, Renato Rodrigues; de ALMEIDA, Marcio Rodrigues; OLTRAMARI-NAVARRO, Paula Vanessa Pedron; CONTI, Ana Cláudia de Castro Ferreira; NAVARRO, Ricardo de Lima; de SOUZA, Karen Regina Siqueira

    2012-01-01

    This paper reports a case treated by a serial extraction program at the mixed dentition stage followed by a corrective orthodontic treatment, with a long-term follow-up period. Twenty years after the interceptive treatment, a harmonious face was observed along with treatment stability in the anterior posterior direction, deep overbite (which has been mentioned as a disadvantage of the serial extraction program), and a small relapse of anterior tooth crowding. All these conditions have been regarded as normal occurrences for most orthodontic treatments with a long-term follow-up period. This case report demonstrated that the establishment of a serial extraction protocol determined relevant esthetic changes that afforded an improvement of the patient's self-esteem, with a positive social impact. Furthermore, the low cost of this protocol permits the use of this therapy with underprivileged populations. It is important to emphasize that an early correction of tooth crowding by this protocol does not guarantee stability, but small relapses do not invalidate its accomplishment. PMID:23032213

  9. Long-term follow-up of atomic bomb survivors.

    Science.gov (United States)

    Sakata, Ritsu; Grant, Eric J; Ozasa, Kotaro

    2012-06-01

    The Life Span Study (LSS) is a follow-up study of atomic bomb (A-bomb) survivors to investigate the radiation effects on human health and has collected data for over 60 years. The LSS cohort consists of 93,741 A-bomb survivors and another 26,580 age and sex-matched subjects who were not in either city at the time of the bombing. Radiation doses have been computed based on individual location and shielding status at the time of the bombings. Age at death and cause of death are gathered through the Japanese national family registry system and cancer incidence data have been collected through the Hiroshima and Nagasaki cancer registries. Noncancer disease incidence and health information are collected through biannual medical examinations among a subset of the LSS. Radiation significantly increases the risks of death (22% at 1 Gy), cancer incidence (47% at 1 Gy), death due to leukemia (310% at 1 Gy), as well as the incidence of several noncancer diseases (e.g. thyroid nodules, chronic liver disease and cirrhosis, uterine myoma, and hypertension). Significant effects on maturity (e.g. growth reduction and early menopause) were also observed. Long-term follow-up studies of the A-bomb survivors have provided reliable information on health risks for the survivors and form the basis for radiation protection standards for workers and the public. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  10. Cold urticaria: a 20-year follow-up study.

    Science.gov (United States)

    Jain, S V; Mullins, R J

    2016-12-01

    Chronic cold urticaria results in significant morbidity, yet information on its natural history is limited. We examined the natural history of chronic cold urticaria and its impact on quality of life. We analysed the characteristics of patients diagnosed with cold urticaria at a community-based specialist allergy practice in the Australian Capital Territory (ACT) between 1995 and 2015. Follow-up data were obtained using a mailed questionnaire. Possible predictive factors of disease severity and symptom duration were evaluated. A total of 99 patients were assessed with a median age of 42 (range 5-81 years); 63% were female and the median age of onset of symptoms was 22 years. Of 41 questionnaire responders (14 ± 10.9 years follow-up; median 12 years), 5- and 10-year resolution rates were 17.9% ± 6.2% and 24.5% ± 7.2%, respectively. Whereas 22% reported resolution and 23% described improvement, the remaining 55% reported stable or worsening disease. Most individuals relied on lifestyle modification to ameliorate symptoms rather than medication. Risk factors for persistent disease were intercurrent atopic disease (P = 0.025) and those with longer duration of symptoms at the time of initial assessment (P urticaria were identified in only two patients, both with B-cell malignancy. In a subset of patients, cold urticaria has low rates of spontaneous resolution and results in lifestyle changes and impaired quality of life. © 2016 European Academy of Dermatology and Venereology.

  11. Serial extraction: 20 years of follow-up.

    Science.gov (United States)

    Almeida, Renato Rodrigues de; Almeida, Marcio Rodrigues de; Oltramari-Navarro, Paula Vanessa Pedron; Conti, Ana Cláudia de Castro Ferreira; Navarro, Ricardo de Lima; Souza, Karen Regina Siqueira de

    2012-01-01

    This paper reports a case treated by a serial extraction program at the mixed dentition stage followed by a corrective orthodontic treatment, with a long-term follow-up period. Twenty years after the interceptive treatment, a harmonious face was observed along with treatment stability in the anterior posterior direction, deep overbite (which has been mentioned as a disadvantage of the serial extraction program), and a small relapse of anterior tooth crowding. All these conditions have been regarded as normal occurrences for most orthodontic treatments with a long-term follow-up period. This case report demonstrated that the establishment of a serial extraction protocol determined relevant esthetic changes that afforded an improvement of the patient's self-esteem, with a positive social impact. Furthermore, the low cost of this protocol permits the use of this therapy with underprivileged populations. It is important to emphasize that an early correction of tooth crowding by this protocol does not guarantee stability, but small relapses do not invalidate its accomplishment.

  12. Serial extraction: 20 years of follow-up

    Directory of Open Access Journals (Sweden)

    Renato Rodrigues de Almeida

    2012-08-01

    Full Text Available This paper reports a case treated by a serial extraction program at the mixed dentition stage followed by a corrective orthodontic treatment, with a long-term follow-up period. Twenty years after the interceptive treatment, a harmonious face was observed along with treatment stability in the anterior posterior direction, deep overbite (which has been mentioned as a disadvantage of the serial extraction program, and a small relapse of anterior tooth crowding. All these conditions have been regarded as normal occurrences for most orthodontic treatments with a long-term follow-up period. This case report demonstrated that the establishment of a serial extraction protocol determined relevant esthetic changes that afforded an improvement of the patient's self-esteem, with a positive social impact. Furthermore, the low cost of this protocol permits the use of this therapy with underprivileged populations. It is important to emphasize that an early correction of tooth crowding by this protocol does not guarantee stability, but small relapses do not invalidate its accomplishment.

  13. THE FOLLOW-UP STUDY IN α-KETOADIPIC ACIDURIA

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    Objective To follow up study on α-ketoadipic aciduria , which is a rare inborn error of metabolism of L-ly sine, hydroxy-L-lysine, and L-tryptophan. Methods The case with α-ketoadipic aciduria was investigated clinically and metabolites were detected by using gas chromatography-mass spectrometry techniques during a period of 15 years (9months~ 15years). Results The case had growth retardation at the onset but later grew normally. The urinary metabolites showed persisent abnormality compatible with α-ketoadipic aciduria. The concentrations of α-ketoadipate , α-aminoadipate and α-hy droxyadipate were 33mmol/mol creatinine, 92~266mmol/mol creatinine and 17~28mmol/mol creatinine , respectively. Glutarate also increased in their urine. Conclusion The study suggested the clinical course of a-ketoadipic aciduria is benign and the clinical manifestations are various. The follow-up study on this case with α-ketoadipic aciduria must be continued.

  14. 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.

  15. Omega-3 fatty acids in the management of autism spectrum disorders: findings from an open-label pilot study in Singapore.

    Science.gov (United States)

    Ooi, Y P; Weng, S-J; Jang, L Y; Low, L; Seah, J; Teo, S; Ang, R P; Lim, C G; Liew, A; Fung, D S; Sung, M

    2015-08-01

    The goal of this open-label trial was to examine the efficacy and safety of a 12-week omega-3 fatty acids supplementation among children suffering with Autism Spectrum Disorders (ASD). A total of 41 children and adolescents aged 7-18 years (36 boys, 5 girls; mean age = 11.66, s.d. = 3.05) diagnosed with ASD participated in the study. At post-treatment, participants showed significant improvements on all subscales of the Social Responsiveness Scale (P fatty acid levels were significantly correlated with changes in the core symptoms of ASD. Baseline levels of blood fatty acid levels were also predictive of response to the omega-3 treatment. Omega-3 fatty acids supplementation was well-tolerated and did not cause any serious side effects. Our findings lend some preliminary support for the use of omega-3 fatty acids supplementation in addressing ASD. Future randomized controlled trials of omega-3 fatty acids in ASD with blood fatty acid measurements with a larger sample and longer follow-up period is warranted.

  16. Effect of enzyme therapy and prognostic factors in 69 adults with Pompe disease: an open-label single-center study

    Directory of Open Access Journals (Sweden)

    de Vries Juna M

    2012-09-01

    Full Text Available Abstract Background Enzyme replacement therapy (ERT in adults with Pompe disease, a progressive neuromuscular disorder, is of promising but variable efficacy. We investigated whether it alters the course of disease, and also identified potential prognostic factors. Methods Patients in this open-label single-center study were treated biweekly with 20 mg/kg alglucosidase alfa. Muscle strength, muscle function, and pulmonary function were assessed every 3–6 months and analyzed using repeated-measures ANOVA. Results Sixty-nine patients (median age 52.1 years were followed for a median of 23 months. Muscle strength increased after start of ERT (manual muscle testing 1.4 percentage points per year (pp/y; hand-held dynamometry 4.0 pp/y; both p Relative to the pre-treatment period (49 patients with 14 months pre-ERT and 22 months ERT median follow-up, ERT affected muscle strength positively (manual muscle testing +3.3 pp/y, p Conclusions We conclude that ERT positively alters the natural course of Pompe disease in adult patients; muscle strength increased and upright FVC stabilized. Functional outcome is probably best when ERT intervention is timely.

  17. 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

    Directory of Open Access Journals (Sweden)

    Manish V. Patel

    2015-01-01

    Full Text Available 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.

  18. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial

    DEFF Research Database (Denmark)

    Home, Philip D; Pocock, Stuart J; Beck-Nielsen, Henning

    2009-01-01

    BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared with the comb......BACKGROUND: Rosiglitazone is an insulin sensitiser used in combination with metformin, a sulfonylurea, or both, for lowering blood glucose in people with type 2 diabetes. We assessed cardiovascular outcomes after addition of rosiglitazone to either metformin or sulfonylurea compared...... with the combination of the two over 5-7 years of follow-up. We also assessed comparative safety. METHODS: In a multicentre, open-label trial, 4447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy with mean haemoglobin A(1c) (HbA(1c)) of 7.9% were randomly assigned to addition of rosiglitazone (n...... were increased mainly in women randomly assigned to rosiglitazone. Mean HbA(1c) was lower in the rosiglitazone group than in the control group at 5 years. INTERPRETATION: Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart...

  19. Suppressive therapy versus episodic therapy with oral valacyclovir for recurrent herpes labialis: efficacy and tolerability in an open-label, crossover study.

    Science.gov (United States)

    Gilbert, Stanley C

    2007-04-01

    Oral valacyclovir's efficacy and tolerability as suppressive therapy versus episodic therapy were compared for recurrent herpes labialis (RHL). Subjects with a history of at least 3 RHL episodes in the past year were randomized to receive 6 months of oral valacyclovir episodic therapy at the first sign of prodrome (two 2-g doses separated by 12 hours) and 6 months of oral valacyclovir suppressive therapy (1 g once daily) for 6 months in open-label, crossover fashion. The mean +/- SE number of recurrences per 120 days of follow-up (primary endpoint) was lower with suppressive therapy (0.30 +/- 0.41) than episodic therapy (0.71 +/- 0.79) (P 180 days) for suppressive therapy (P = 0.021). Data for secondary efficacy endpoints (pain severity score, mean duration of recurrences, maximal total lesion area) showed approximately a 30% to 50% reduction in mean values with suppressive therapy compared with episodic therapy, but results were statistically significantly different between the regimens for pain severity only. The percentage of subjects with at least one adverse event over 6 months of treatment that was considered to be drug related was 3% with suppressive therapy and 6% with episodic therapy. Suppressive therapy with oral valacyclovir was more effective than episodic therapy with oral valacyclovir in reducing the frequency of recurrences of herpes labialis and prolonging the time to first recurrence and was also similarly well-tolerated.

  20. 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

  1. Effectiveness of telemedicine and distance learning applications for patients with chronic heart failure. A protocol for prospective parallel group non-randomised open label study.

    Science.gov (United States)

    Vanagas, Giedrius; Umbrasiene, Jelena; Slapikas, Rimvydas

    2012-01-01

    Chronic heart failure in Baltic Sea Region is responsible for more hospitalisations than all forms of cancer combined and is one of the leading causes of hospitalisations in elderly patients. Frequent hospitalisations, along with other direct and indirect costs, place financial burden on healthcare systems. We aim to test the hypothesis that telemedicine and distance learning applications is superior to the current standard of home care. Prospective parallel group non-randomised open label study in patients with New York Heart Association (NYHA) II-III chronic heart failure will be carried out in six Baltic Sea Region countries. The study is organised into two 6-month follow-up periods. The first 6-month period is based on active implementation of tele-education and/or telemedicine for patients in two groups (active run period) and one standard care group (passive run period). The second 6-month period of observation will be based on standard care model (passive run period) to all three groups. Our proposed practice change is based on translational research with empirically supported interventions brought to practice and aims to find the home care model that is most effective to patient needs. This study has been approved by National Bioethics Committee (2011-03-07; Registration No: BE-2-11). This study has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR) with registration number ACTRN12611000834954.

  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

    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.

  3. 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

  4. Efficacy of two versus three-day regimens of dihydroartemisinin-piperaquine for uncomplicated malaria in military personnel in northern Cambodia: an open-label randomized trial.

    Directory of Open Access Journals (Sweden)

    Chanthap Lon

    Full Text Available Emerging antimalarial drug resistance in mobile populations remains a significant public health concern. We compared two regimens of dihydroartemisinin-piperaquine in military and civilians on the Thai-Cambodian border to evaluate national treatment policy.Efficacy and safety of two and three-day regimens of dihydroartemisinin-piperaquine were compared as a nested open-label evaluation within a malaria cohort study in 222 otherwise healthy volunteers (18% malaria-infected at baseline. The first 80 volunteers with slide-confirmed Plasmodium falciparum or vivax malaria were randomized 1:1 to receive either regimen (total dose 360 mg dihydroartemisinin and 2880 mg piperaquine and followed weekly for up to 6 months. The primary endpoint was malaria recurrence by day 42. Volunteers with vivax infection received primaquine at study discharge with six months follow-up.Eighty patients (60 vivax, 15 falciparum, and 5 mixed were randomized to dihydroartemisinin-piperaquine. Intention-to-treat all-species efficacy at Day 42 was 85% for the two-day regimen (95% CI 69-94 and 90% for the three-day regimen (95% CI 75-97. PCR-adjusted falciparum efficacy was 75% in both groups with nearly half (45% still parasitemic at Day 3. Plasma piperaquine levels were comparable to prior published reports, but on the day of recrudescence were below measurable in vitro piperaquine IC50 levels in all falciparum treatment failures.In the brief period since introduction of dihydroartemisinin-piperaquine, there is early evidence suggesting declining efficacy relative to previous reports. Parasite IC50 levels in excess of plasma piperaquine levels seen only in treatment failures raises concern for clinically significant piperaquine resistance in Cambodia. These findings warrant improved monitoring of clinical outcomes and follow-up, given few available alternative drugs.ClinicalTrials.gov NCT01280162.

  5. Effect of enzyme therapy in juvenile patients with Pompe disease: a three-year open-label study.

    NARCIS (Netherlands)

    Capelle, C.I. van; Beek, N.A. van der; Hagemans, M.L.; Arts, W.F.M.; Hop, W.C.J.; Lee, P.; Jaeken, J.; Frohn-Mulder, I.M.; Merkus, P.J.F.M.; Corzo, D.; Puga, A.C.; Reuser, A.J.J.; Ploeg, A.T. van der

    2010-01-01

    Pompe disease is a rare neuromuscular disorder caused by deficiency of acid alpha-glucosidase. Treatment with recombinant human alpha-glucosidase recently received marketing approval based on prolonged survival of affected infants. The current open-label study was performed to evaluate the response

  6. Open-label trial of anti-TNF-alpha in dermato- and polymyositis treated concomitantly with methotrexate

    DEFF Research Database (Denmark)

    Hengstman, G.J.; Bleecker, J.L. De; Feist, E.

    2008-01-01

    BACKGROUND/AIMS: To determine the efficacy of infliximab combined with weekly methotrexate in drug-naive recent-onset dermatomyositis and polymyositis. METHODS: A multicentre open-label controlled trial was conducted. Disease activity was assessed using patient's and physician's disease activity...

  7. Effect of enzyme therapy in juvenile patients with Pompe disease: a three-year open-label study.

    NARCIS (Netherlands)

    Capelle, C.I. van; Beek, N.A. van der; Hagemans, M.L.; Arts, W.F.M.; Hop, W.C.J.; Lee, P.; Jaeken, J.; Frohn-Mulder, I.M.; Merkus, P.J.F.M.; Corzo, D.; Puga, A.C.; Reuser, A.J.J.; Ploeg, A.T. van der

    2010-01-01

    Pompe disease is a rare neuromuscular disorder caused by deficiency of acid alpha-glucosidase. Treatment with recombinant human alpha-glucosidase recently received marketing approval based on prolonged survival of affected infants. The current open-label study was performed to evaluate the response

  8. An Open-Label Study of Aripiprazole : Pharmacokinetics, Tolerability, and Effectiveness in Children and Adolescents with Conduct Disorder

    NARCIS (Netherlands)

    Findling, Robert L.; Kauffman, Ralph; Sallee, Floyd R.; Salazar, Daniel E.; Sahasrabudhe, Vaishali; Kollia, Georgia; Kornhauser, David M.; Vachharajani, Nimish N.; Assuncao-Talbott, Sheila; Mallikaarjun, Suresh; Iwamoto, Taro; McQuade, Robert D.; Boulton, David W.; Blumer, Jeffrey

    2009-01-01

    Objectives: This study evaluated flexible-dose pharmacokinetics, safety, and effectiveness of aripiprazole in children and adolescents with conduct disorder (CD). Methods: This open-label, 15-day, three-center study with an optional 36-month extension enrolled a total of 23 patients: 12 children (6-

  9. An Open-Label Study of Aripiprazole : Pharmacokinetics, Tolerability, and Effectiveness in Children and Adolescents with Conduct Disorder

    NARCIS (Netherlands)

    Findling, Robert L.; Kauffman, Ralph; Sallee, Floyd R.; Salazar, Daniel E.; Sahasrabudhe, Vaishali; Kollia, Georgia; Kornhauser, David M.; Vachharajani, Nimish N.; Assuncao-Talbott, Sheila; Mallikaarjun, Suresh; Iwamoto, Taro; McQuade, Robert D.; Boulton, David W.; Blumer, Jeffrey

    Objectives: This study evaluated flexible-dose pharmacokinetics, safety, and effectiveness of aripiprazole in children and adolescents with conduct disorder (CD). Methods: This open-label, 15-day, three-center study with an optional 36-month extension enrolled a total of 23 patients: 12 children

  10. Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa

    NARCIS (Netherlands)

    Olivennes, F.; Trew, G.; Borini, A.; Broekmans, F.; Arriagada, P.; Warne, D. W.; Howles, C. M.

    2015-01-01

    In this randomized, controlled, open-label, phase IV study, ovarian response after a follitropin alfa starting dose determined by the CONSORT calculator was compared with a standard dose (150 IU). Normo-ovulatory women (aged 18-34 years) eligible for assisted reproductive techniques were recruited (

  11. Loss to follow up within an HIV cohort

    Directory of Open Access Journals (Sweden)

    H Wood

    2012-11-01

    Full Text Available BHIVA guidelines recommend that all ARV-naïve and stable on-treatment patients are monitored at least 6 monthly [1]. Studies have shown that loss to follow up (LFU not only worsens outcomes [2] but has increased potential for onward transmission. Case notes of 1275 HIV patients registered under our care up to January 2011 were examined for attendance within the previous 6 months. 788 (61% patients had not been seen within the previous 6 months. Reasons for non attendance were identified. These are outlined below: 76% of the 130 LFU whose demographics were further examined were of Black African ethnicity, 54% female, 51% of single marital status and 48% of patients had been taking ARVs at the time of LFU. Interestingly, 53% of patients were lost to follow up within 1 year of diagnosis. The LFU patients (88 that had a local GP and a registered current address were sent recall letters. A small number of patients reengaged with care as a result of this action, some having not attended for over 5 years. Partner notification led to a number of new diagnoses in these cases. Failure to respond led to subsequent letters inviting them to clinic and finally a letter to their GP informing them of non attendance. In September 2011, a new recall system using Lillie Electronic Patient Records (EPR was introduced to promptly recognise if a patient had not attended for care as planned. Prior to this, recall was a manual process carried out by the Health Advising Team. We conclude that within our cohort we had a particularly mobile group of patients; 455 (36% transferring care to another clinic within the UK, 54 (4% moving out of UK. 76% of the LFU group being of Black African ethnicity highlights the ongoing problem of retention of care in this group. Further exploration is needed to identify additional issues besides housing and immigration that lead to LFU. Furthermore, the disportionate number of patients (53% disengaging with services within 1 year of

  12. A Multicenter Pivotal Study to Evaluate Tissue Stabilized-Guided Subcision Using the Cellfina Device for the Treatment of Cellulite With 3-Year Follow-up.

    Science.gov (United States)

    Kaminer, Michael S; Coleman, William P; Weiss, Robert A; Robinson, Deanne M; Grossman, Jody

    2017-06-28

    Cellulite is a common female cosmetic concern for which no single treatment option had been proven effective over the long term. A novel tissue stabilized-guided subsicion system (TS-GS system) has demonstrated significant reduction in the appearance of cellulite after treatment. The objective of this extended follow-up period was to assess the effectiveness of TS-GS out to 3 years after initial treatment. After completing an open-label, multicenter, pivotal study, 45 subjects were followed for an extended period of up to 3 years after receiving a single treatment using the TS-GS system. Treatment areas were photographed prior to the procedure and at multiple time points post-treatment throughout the 3 years. In this open-label study, subjects served as their own controls. Effectiveness was assessed based on blinded independent physician panel assessments of improvement from baseline using a cellulite severity scale. Subject aesthetic improvement and patient-reported satisfaction were also collected. The results of this trial supported Food and Drug Administration clearance of the device for the long-term reduction in the appearance of cellulite following TS-GS. These data further demonstrate the safety and efficacy of this treatment with no reduction in treatment benefits out to 3 years.

  13. [Obesity surgery--useful knowledge in indication and follow up].

    Science.gov (United States)

    Scheiwiller, A; Sykora, M

    2009-10-07

    In the last years, obesity has become one of the main problems of health care systems in Western countries. Among morbid obese patients, four out of five will develop comorbidities doubling the mortality risk in women and increase the numbers in men at a threefold risk. According to evidence based guidelines, nowadays surgery is the best and most effective treatment resulting in excellent long-term weight loss, reduction of comorbidities while extending expectation of life. A sound indication is the most important step for successful surgery. In this paper we focus on Swiss regulations and some special indications which have to be taken into consideration. After bariatric surgery clinical follow up on a regular basis is also of great importance. Furthermore, we explain typical mechanical and nutritional complications after different types of surgery and give some recommendations.

  14. The Danish Cerebral Palsy Follow-up Program

    DEFF Research Database (Denmark)

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

    2016-01-01

    -15 years and children with symptoms of CP aged 0-5 years. MAIN VARIABLES: In the follow-up program, the children are offered examinations throughout their childhood by orthopedic surgeons, physiotherapists, occupational therapists, and pediatricians. Examinations of gross and fine motor function, manual...... ability, muscle tone, passive range of motion, use of orthotics, and assistive devices are performed once a year; radiographic examination of the hips is planned based on the child's age and gross motor function; and the diagnosis is performed once before the age of 5 years. Six indicators were developed...... based on scientific literature and consensus in the steering committee, and their calculation is based on the following four main variables: radiographic examination of the hip, gross motor function, manual ability, and diagnosis. DESCRIPTIVE DATA: The 2014 annual report includes results of the quality...

  15. Home/community monitoring using telephonic follow-up.

    Science.gov (United States)

    Martin, Elisabeth Moy; French, Louis; Janos, Alicia

    2010-01-01

    Service members who have had a traumatic brain injury (TBI) in a war theatre [Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF)] may have associated injuries far different and/or more complex (i.e., polytrauma) than injuries obtained outside the theatre of operation. This article expands on what has been learned from monitoring patients injured during peacetime to the newly injured war veterans being monitored in the home setting via routine telephonic follow-up. As Tanielian et al. state TBI, post traumatic stress disorder (PTSD) and major depression may occur during and following deployment/s which then pose a significant health risk to these veterans. This is particularly important as veterans of these two conflicts may incur these "invisible wounds of war". Thus, safe and effective monitoring of these veterans by nurses/case managers in the home/community setting becomes important in the recovery process.

  16. Spheroid degeneration of conjunctiva and cornea. Two years' follow up.

    Science.gov (United States)

    Norn, M

    1980-10-01

    Twenty-six subjects with spheroid degeneration were followed up after two years. The number of colourless conjunctival droplets was seen to have increased by on an average 46% (2 alpha = 0.05) and that of autofluorescent conjunctival droplets by 223% (2 alpha less than 0.01). Counting within the individual sites sites disclosed that some droplets will disappear (not less than 30 and 21% respectivelY), while recently formed will constitute at least 76 and 243%. The number of areas with band-shaped keratopathy was found to rise from 3 to 26 (P less than 0.001) out of 104 possibilities, (nasally and temporally of right and left eye). Vital staining (fluorescein, rose bengal, tetrazolium, alcian blue) showed the epithelium above the droplets to be intact, and the droplet-containing eyes were found not to be abnormally dry (break up time, tear production).

  17. 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.)

  18. MANDIBULAR INCISOR EXTRACTION: A 5-YEAR FOLLOW-UP

    Directory of Open Access Journals (Sweden)

    Kadir BEYCAN

    2016-10-01

    Full Text Available This case report presents the mandibular incisor extraction treatment of a patient with dental Class I malocclusion and lower crowding, in whom one mandibular incisor extraction was selected as the treatment of choice to improve the dental occlusion. A 19-year-old male patient’s chief complaint was the crowding of lower incisors. He had a straight profile with normal upper and lower lip projection. Upper and lower dental midlines were coincident with the facial midline. The patient had Class I molar and canine relationships on both sides. He had Class I skeletal relationship, low angle vertical pattern, and proclined upper and lower incisors. The treatment plan included the extraction of lower right central incisor to resolve the crowding. At the end of 16-month active fixed treatment, lower dental crowding was resolved. At the 5-year follow-up, the patient had a stable occlusion, with the results of the orthodontic treatment maintained.

  19. Pulmonary radiofrequency ablation (Part 2): Procedure and follow-up.

    Science.gov (United States)

    Plasencia Martínez, J M

    2015-01-01

    Pulmonary radiofrequency ablation requires more than just interventional radiology skills. Patients must be selected carefully, and the acts that need to be done before, during, and after the procedure must be coordinated. To guarantee patient safety, radiologists need to know the variants of the technique, the precautions that must be taken, the complications that can occur, and the risks involved. Early differentiation between tumor tissue and normal changes secondary to treatment on imaging tests will make it possible to repeat the treatment without delays, and this will increase survival. This article describes how to coordinate and carry out pulmonary radiofrequency ablation, the complications of the technique, and the current evidence in follow-up. Copyright © 2014 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

  20. Electronic Whiteboards and Intensive Care Unit follow up

    DEFF Research Database (Denmark)

    Østergaard, Kija Lin; Brandrup, Morten

    /collaboration and 2) information. However no literature has been found on how to maintain the communication and collaboration between wards when time of the respectively project has run out. Research on electronic whiteboards in hospital settings find that supporting communication between e.g. wards and the transfer......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...... of information is optimized using an electronic whiteboard. Negative findings in the research on electronic whiteboards are present too e.g. it is crucial to have the same use language when sharing the same interface and reports on system in-flexibility; dash-board (standardized use of language) vs. open...

  1. [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.

  2. A New GRB follow-up Software at TUG

    Science.gov (United States)

    Dindar, M.; Parmaksizoglu, M.; Helhel, S.; Esenoglu, H.; Kirbiyik, H.

    2016-12-01

    A gamma-ray burst (GRB) optical photometric follow-up system at TUBITAK (Scientic and Technological Research Council of Turkey) National Observatory (TUG) has been planned. It uses the 0.6 m Telescope (T60) and can automatically respond to GRB Coordinates Network (GCN) alerts. The telescopes slew relatively fast, being able to point to a new target field within 30 s upon a request. Whenever available, the 1 m T100 and 2.5 m RTT150 telescopes will be used in the future. As an example in 2015, the GRB software system (will be server side) at T60-telescope responded to GRB alert and started the observation as early as 129 s after the GRB trigger autonomously.

  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. Facilitation of DDD follow-up using the DDT mode.

    Science.gov (United States)

    Kamke, W; Nitschke, M; Gutschker, A; Worzewski, W

    1992-11-01

    To facilitate follow-up, modern dual chamber pacemakers provide a variety of diagnostic features like ECG interpretation channels and intracardiac electrograms. For evaluation of the sensing performance at rest and during exercise, for assessment of the presence of crosstalk, and for measurement of the retrograde conduction time, dual chamber triggered pacing, particularly the DDT mode, can be used alternatively or additionally in pacemakers equipped with this option. In contrast to ECG interpretation channels, ECG documentation is not required for evaluation of the sensing performance, because the triggered pulses serving as markers for sense events can also be seen on the monitor. Selection of the DDT mode not only as temporary but also as permanent program serves to facilitate pacemaker ECG interpretation for exercise tests and Holter recordings as well.

  5. Leflunomide treatment in corticosteroid-dependent myasthenia gravis: an open-label pilot study.

    Science.gov (United States)

    Chen, Pei; Feng, Huiyu; Deng, Juan; Luo, Yufei; Qiu, Li; Ou, Changyi; Liu, Weibin

    2016-01-01

    Leflunomide is an effective drug used in the treatment of rheumatoid arthritis. Here we report the findings of an open-label pilot study, which found that leflunomide is also an effective treatment for myasthenia gravis (MG). This study recruited 15 corticosteroid-dependent MG patients. For 6 months, leflunomide 20 mg was given to these patients daily along with prednisone. The quantitative myasthenia gravis (QMG) scores and MG activities of daily living (MG-ADL) profiles were measured in these MG patients. After 6 months of treatment, 9 of the 15 patients enrolled in this study showed improvements in both QMG and MG-ADL. The mean QMG scores (13.4 to 8.5) and MG-ADL profiles (5.8 to 2.8) were significantly decreased (P = 0.01, 0.006 respectively). Furthermore, we found that the mean corticosteroid doses were reduced after treatment with leflunomide (24.3 to 12.3 mg per day). Leflunomide is a well-tolerated and efficacious treatment for corticosteroid-dependent MG, which may also enable lower doses of corticosteroids to be administered.

  6. 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.

  7. "Burst" ketamine for refractory cancer pain: an open-label audit of 39 patients.

    Science.gov (United States)

    Jackson, K; Ashby, M; Martin, P; Pisasale, M; Brumley, D; Hayes, B

    2001-10-01

    The results of a novel approach to the use of ketamine in refractory cancer pain are reported. In this prospective, multicenter, unblinded, open-label audit, 39 patients (with a total of 43 pains) received a short duration (3 to 5 days) ketamine infusion. The initial dose of 100 mg/24 hr was escalated if required to 300 mg/24 hr and then to a maximum dose of 500 mg/24hr. The overall response rate was 29/43 (67%). Analysis of results according to pain mechanisms showed that 15/17 somatic and 14/23 neuropathic pains responded. In 5 patients who appeared to respond, it is possible that another concurrent intervention may have contributed in whole or part for the pain relief observed. After cessation of ketamine, 24/29 maintained good pain control, with a maximum documented duration of eight weeks. However, 5 of the initial 29 responders experienced a recurrence of pain within 24 hours, and ketamine was recommenced. Of these, 2 underwent another intervention for pain control while 3 continued on ketamine until their deaths between two and four weeks later. Twelve patients reported adverse psychomimetic effects, with the incidence rising with increasing dose. Four of these were non-responders and the ketamine was stopped. Eight were responders, and in 3 the adverse effects were rendered acceptable with dose reduction; the other 5 rejected a dose reduction. The results reported suggest the need for further investigation of the place of ketamine in cancer pain management.

  8. 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 < 0.001), and lower rates of squamous cell carcinoma of the skin (0% vs 5%; P = 0.012). Conclusions Our findings suggest that 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

  9. EFFICACY AND SAFETY OF SIMVASTATIN IN RHEUMATOID ARTHRITIS: AN OPEN-LABEL, CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    I. V. Shirinsky

    2008-01-01

    Full Text Available Abstract. Recently discovered immune–modulating and anti-inflammatory properties of statins have resulted in application of these drugs for treatment of autoimmune disorders. There are few studies investigating therapeutic potential of simvastatin in rheumatoid arthritis (RA. In present study, we investigated efficacy and safety of simvastatin in active RA patients treated with conventional disease-modifying antirheumatic drugs (DMARDs. Thirty-three patients were enrolled into an open-label, controlled study. The patients received treatment with 40 mg of simvastatin daily for 12 weeks. A group of historical controls consisted of nine patients taking placebo combined with disease-modifying therapy. No differences in demographic characteristics and disease activity were observed between the two groups. By the end of therapy (12 weeks, simvastatin-treated patients exhibited a significant reduction in disease activity scores with 28-joint counts (DAS28, and according to physician’s assessment of disease, as compared with control group. The estimate of trea tment effect (DAS28 scores was 0.76 (95% confidence interval 0.01-1.5, thus corresponding to moderate decrease in disease activity. In conclusion, combination therapy with simvastatin and conventional DMARDs results into decreased RA activity. However, additional studies are required in order to specify exact role of simvastatin in RA treatment. (Med. Immunol., vol. 10, N 4-5, pp 477-482.

  10. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial.

    Science.gov (United States)

    Nguyen, Liem Thanh; Nguyen, Anh Tuan; Vu, Chinh Duy; Ngo, Doan V; Bui, Anh V

    2017-04-12

    Stem cell therapy has emerged as a promising method for improving motor function of patients with cerebral palsy. The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation in patients with cerebral palsy related to oxygen deprivation. An open label uncontrolled clinical trial was carried out at Vinmec International Hospital. The intervention consisted of two administrations of stem cells, the first at baseline and the second 3 months later. Improvement was monitored at 3 months and 6 months after the first administration of stem cells, using the Gross Motor Function Measure (GMFM) and Modified Ashworth Score which measures muscle tone. No severe complications were recorded during the study. After transplantation, 12 patients encountered fever without infections and 9 patients experienced vomiting which was easily managed with medications. Gross motor function was markedly improved 3 months or 6 months after stem cell transplantation than at baseline. The post-transplantation GMFM-88 total score, each of its domains and the GMFM-66 percentile were all significantly higher (p-value  0.05). Autologous bone marrow mononuclear cell transplantation appears to be a safe and effective therapy for patients with cerebral palsy. ClinicalTrials.gov Identifier: NCT02569775 . Retrospectively registered on October 15, 2015.

  11. Flaxseed supplementation in non-alcoholic fatty liver disease: a pilot randomized, open labeled, controlled study.

    Science.gov (United States)

    Yari, Zahra; Rahimlou, Mehran; Eslamparast, Tannaz; Ebrahimi-Daryani, Naser; Poustchi, Hossein; Hekmatdoost, Azita

    2016-06-01

    A two-arm randomized open labeled controlled clinical trial was conducted on 50 patients with non-alcoholic fatty liver disease (NAFLD). Participants were assigned to take either a lifestyle modification (LM), or LM +30 g/day brown milled flaxseed for 12 weeks. At the end of the study, body weight, liver enzymes, insulin resistance and hepatic fibrosis and steatosis decreased significantly in both groups (p< 0.05); however, this reduction was significantly greater in those who took flaxseed supplementation (p < 0.05). The significant mean differences were reached in hepatic markers between flaxseed and control group, respectively: ALT [-11.12 compared with -3.7 U/L; P< 0.001], AST [-8.29 compared with -4 U/L; p < 0.001], GGT [-15.7 compared with -2.62 U/L; p < 0.001], fibrosis score [-1.26 compared with -0.77 kPa; p = 0.013] and steatosis score [-47 compared with -15.45 dB/m; p = 0.022]. In conclusion, flaxseed supplementation plus lifestyle modification is more effective than lifestyle modification alone for NAFLD management.

  12. A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD

    Directory of Open Access Journals (Sweden)

    Tara Rheault

    2016-04-01

    Full Text Available This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease. This was a 12-week, multicentre, randomised, open-label, parallel-group study (Clinicaltrials.gov: NCT02236611. Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV1 at day 85 in the per-protocol population. Other endpoints included: weighted mean FEV1 over 0–24 h and patient-reported outcomes (transition dyspnoea index score and St George's Respiratory Questionnaire total score. Adverse events were also assessed. A total of 1037 patients were randomised to treatment. Umeclidinium was non-inferior (margin: −50 mL to glycopyrronium (trough FEV1 at day 85 treatment difference: 24 mL, 95% confidence intervals: −5–54. Improvements in other endpoints were similar between treatments. Adverse event incidences were similar for umeclidinium (37% and glycopyrronium (36%. Once-daily umeclidinium was non-inferior to once-daily glycopyrronium in patients with chronic obstructive pulmonary disease in trough FEV1 at day 85. Patient-reported outcomes and safety profiles were similar for both treatments.

  13. A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD.

    Science.gov (United States)

    Rheault, Tara; Khindri, Sanjeev; Vahdati-Bolouri, Mitra; Church, Alison; Fahy, William A

    2016-04-01

    This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease. This was a 12-week, multicentre, randomised, open-label, parallel-group study (Clinicaltrials.gov: NCT02236611). Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at day 85 in the per-protocol population. Other endpoints included: weighted mean FEV1 over 0-24 h and patient-reported outcomes (transition dyspnoea index score and St George's Respiratory Questionnaire total score). Adverse events were also assessed. A total of 1037 patients were randomised to treatment. Umeclidinium was non-inferior (margin: -50 mL) to glycopyrronium (trough FEV1 at day 85 treatment difference: 24 mL, 95% confidence intervals: -5-54). Improvements in other endpoints were similar between treatments. Adverse event incidences were similar for umeclidinium (37%) and glycopyrronium (36%). Once-daily umeclidinium was non-inferior to once-daily glycopyrronium in patients with chronic obstructive pulmonary disease in trough FEV1 at day 85. Patient-reported outcomes and safety profiles were similar for both treatments.

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

    Science.gov (United States)

    Ramaswamy, Sriram; Madabushi, Jayakrishna; Hunziker, John; Bhatia, Subhash C.; Petty, Frederick

    2015-01-01

    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. PMID:26064685

  15. An open-label conversion study of pramipexole to ropinirole prolonged release in Parkinson's disease.

    Science.gov (United States)

    Lyons, Kelly E; Pahwa, Rajesh

    2009-10-30

    Ropinirole prolonged release (PR) is a once daily oral dopamine agonist approved for the treatment of Parkinson's disease (PD). The goal of this 4 week, open-label study was to determine the most effective conversion ratio with the fewest adverse effects (AEs) when switching from pramipexole to ropinirole PR. Sixty patients with PD taking pramipexole were converted overnight to ropinirole PR at ratios of 1:3, 1:4, or 1:5 such that 20 consecutive subjects were enrolled in each group. Ropinirole PR dose adjustments were allowed to maintain efficacy or to reduce AEs. An overnight switch from pramipexole to ropinirole PR was found to be well tolerated and AEs were typical for a dopamine agonist. The most common AEs were worsening of PD symptoms, dizziness, somnolence, and nausea, the majority of which resolved after dose adjustments. Thirteen subjects discontinued ropinirole PR before 4 weeks. These subjects were taking a significantly greater dose of pramipexole, the majority greater than 4 mg/day, and tended to have longer disease durations. A conversion ratio of 1 mg of pramipexole to 4 mg of ropinirole PR resulted in the fewest discontinuations of ropinirole PR, the fewest dose adjustments and the largest percentage of subjects that preferred ropinirole PR.

  16. 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 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.

  17. Neural correlates of change in major depressive disorder anhedonia following open-label ketamine.

    Science.gov (United States)

    Lally, Níall; Nugent, Allison C; Luckenbaugh, David A; Niciu, Mark J; Roiser, Jonathan P; Zarate, Carlos A

    2015-05-01

    Anhedonia is a cardinal symptom of major depression and is often refractory to standard treatment, yet no approved medication for this specific symptom exists. In this exploratory re-analysis, we assessed whether administration of rapid-acting antidepressant ketamine was associated specifically with reduced anhedonia in medication-free treatment-refractory patients with major depressive disorder in an open-label investigation. Additionally, participants received either oral riluzole or placebo daily beginning 4 hours post-infusion. A subgroup of patients underwent fluorodeoxyglucose positron emission tomography scans at baseline (1-3 days pre-infusion) and 2 hours post-ketamine infusion. Anhedonia rapidly decreased following a single ketamine infusion; this was sustained for up to three days, but was not altered by riluzole. Reduced anhedonia correlated with increased glucose metabolism in the hippocampus and dorsal anterior cingulate cortex (dACC) and decreased metabolism in the inferior frontal gyrus and orbitofrontal cortex (OFC). The tentative relationship between change in anhedonia and glucose metabolism remained significant in dACC and OFC, and at trend level in the hippocampus, a result not anticipated, when controlling for change in total depression score. Results, however, remain tenuous due to the lack of a placebo control for ketamine. In addition to alleviating overall depressive symptoms, ketamine could possess anti-anhedonic potential in major depressive disorder, which speculatively, may be mediated by alterations in metabolic activity in the hippocampus, dACC and OFC. © The Author(s) 2015.

  18. Open-label study of duloxetine for the treatment of obsessive-compulsive disorder.

    Science.gov (United States)

    Dougherty, Darin D; Corse, Andrew K; Chou, Tina; Duffy, Amanda; Arulpragasam, Amanda R; Deckersbach, Thilo; Jenike, Michael A; Keuthen, Nancy J

    2015-01-01

    This study sought to investigate the efficacy of duloxetine for the treatment of obsessive-compulsive disorder (DSM-IV). Twenty individuals were enrolled in a 17-week, open-label trial of duloxetine at Massachusetts General Hospital. Data were collected between March 2007 and September 2012. Study measures assessing obsessive-compulsive disorder symptoms, quality of life, depression, and anxiety were administered at baseline and weeks 1, 5, 9, 13, and 17. The primary outcome measures were the Yale-Brown Obsessive Compulsive Scale and Clinical Global Improvement scale. For the 12 study completers, pre- and posttreatment analyses revealed significant improvements (Pobsessive-compulsive disorder symptoms and quality of life. Among the 12 completers, more than one-half (n=7) satisfied full medication response criteria. Intention-to-treat analyses (n=20) showed similar improvements (Pobsessive-compulsive disorder. ClinicalTrials.gov NCT00464698; http://clinicaltrials.gov/ct2/show/NCT00464698?term=NCT00464698&rank=1. © The Author 2015. Published by Oxford University Press on behalf of CINP.

  19. 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.

  20. Male sexual dysfunctions and multimedia immersion therapy (follow-up).

    Science.gov (United States)

    Optale, Gabriele; Marin, Silvia; Pastore, Massimiliano; Nasta, Alberto; Pianon, Carlo

    2003-06-01

    The aim of the study was to evaluate the efficiency, after 1 year, of combined use of psychodynamic psychotherapy integrating virtual reality (VR) for the treatment of erectile dysfunction (ED) and premature ejaculation (PE) in 160 heterosexual males who had neither any prior sexual therapy nor had made use (either before, during or after therapy) of any specific pharmaceuticals for the treatment of primary sexual dysfunction. All subjects had given their informed consent. After a clinical diagnosis in an andrologic center, 50 presumably psychological ED (average age 43.7 years), 60 mixed ED (53.9 years) and 50 primary PE (39 years) who suffered these problems over 6 months were undergoing a cycle of 12 sessions, over a 25-week period, of psychotherapy, integrating an audio CD and helmet with miniature television screens that projected specially designed CD-ROM program on the ontogenetic development of male sexual identity. The clinical follow up was done after 6 and 12 months after the cycle. After one year, the overall partial (two times out of three) and complete positive response rate for psychological ED was 75%, for mixed ED was 47% and for PE was 54%. We considered drop-out cases as only before the 7th session of the treatment cycle, the drop-outs after session 7 and the patients that did not show up for follow-up are counted as negative results. Two patients reported nausea and one, vertigo during the first 15-min virtual reality experience. Considering the particular way that full-immersion virtual reality involves the subject who experiences it, we hypothesized that this methodological approach could speed up the therapeutic process. The evidence that positive results persist over time allows us to hypothesize that certain changes in cerebral function can be possible and that these changes are correlated to favorable sexual performance in the male.

  1. Rectal leiomyosarcoma, three-year follow-up

    Directory of Open Access Journals (Sweden)

    Juliano Alves Figueiredo

    2012-03-01

    Full Text Available Rectal leiomyosarcomas are rare tumors originated from smooth muscle cells. Differential diagnosis includes gastrointestinal stromal tumors (GIST, leiomyomas or schwannomas, and the differentiation of these tumors is usually made through immunohistochemistry. Due to its rarity, the standard treatment has not been defined. The purpose of this study was to present the follow-up of a patient with leiomyosarcoma of medium rectum submitted to exclusive operative treatment. The tumor size was 6 cm and it had a high mitotic index. The patient remains with good urinary function and good sphincter function, and free of the disease after a three-year follow-up.Os leiomiossarcomas retais são tumores raros e originários de células de músculo liso. O diagnóstico diferencial inclui tumores estromais do trato gastrointestinal (GIST, leiomiomas ou schwannomas, e a diferenciação desses tumores normalmente é feita por imunohistoquímica. Devido a sua raridade, o tratamento-padrão ainda não está bem definido. O objetivo deste relato foi mostrar o seguimento de um paciente com leiomiossarcoma de reto médio submetido a tratamento operatório exclusivo. O paciente se manteve com bom controle urinário e boa função evacuatória. O tumor tinha alto índice mitótico e tamanho de 6 cm, mas não há sinais de recidiva após três anos da operação.

  2. Long-term follow-up of elite controllers

    Science.gov (United States)

    Stafford, Kristen A.; Rikhtegaran Tehrani, Zahra; Saadat, Saman; Ebadi, Maryam; Redfield, Robert R.; Sajadi, Mohammad M.

    2017-01-01

    Abstract To estimate the effect of hepatitis C virus (HCV) coinfection on the development of complications and progression of human immunodeficiency virus (HIV) disease among HIV-infected elite controllers. Single-center retrospective cohort. Kaplan–Meier methods, prevalence ratios, and Cox proportional-hazards models were used. In all, 55 HIV-infected elite controllers were included in this study. Among them, 45% were HIV/HCV coinfected and 55% were HIV mono-infected. Median follow-up time for the cohort was 11 years. Twenty-five patients experienced a complication and 16 lost elite controller status during the study period. HCV coinfected patients were 4.78 times (95% confidence interval 1.50–15.28) more likely to develop complications compared with HIV mono-infected patients. There was no association between HCV coinfection status and loss of elite control (hazard ratio 0.75, 95% confidence interval 0.27–2.06). Hepatitis C virus coinfection was significantly associated with the risk of complications even after controlling for sex, injecting drug use, and older age. HCV coinfected patients had higher levels of cellular activation while also having similar levels of lipopolysaccharide and soluble CD14. HCV coinfection was not associated with loss of elite controller status. Taken together, this suggests that HCV coinfection does not directly affect HIV replication dynamics or natural history, but that it may act synergistically with HIV to produce a greater number of associated complications. Continued follow-up will be needed to determine whether HCV cure through the use of direct-acting antivirals among HIV/HCV coinfected elite controllers will make the risk for complications among these patients similar to their HIV mono-infected counterparts. PMID:28658155

  3. The Iowa follow-up of chemically sensitive persons.

    Science.gov (United States)

    Black, D W; Okiishi, C; Schlosser, S

    2001-03-01

    Clinical symptoms and self-reported health status in persons reporting multiple chemical sensitivities (MCS) are presented from a 9-year follow-up study. Eighteen (69%) subjects from a sample of 26 persons originally interviewed in 1988 were followed up in 1997 and given structured interviews and self-report questionnaires. In terms of psychiatric diagnosis, 15 (83%) met DSM-IV criteria for a lifetime mood disorder, 10 (56%) for a lifetime anxiety disorder, and 10 (56%) for a lifetime somatoform disorder. Seven (39%) of subjects met criteria for a personality disorder using the Personality Diagnostic Questionnaire-IV. Self-report data from the Illness Behavior Questionnaire and Symptom Checklist-90-Revised show little change from 1988. The 10 most frequent complaints attributed to MCS were headache, memory loss, forgetfulness, sore throat, joint aches, trouble thinking, shortness of breath, back pain, muscle aches, and nausea. Global assessment showed that 2 (11%) had "remitted", 8 (45%) were "much" or "very much" improved, 6 (33%) were "improved", and 2 (11%) were "unchanged/worse". Mean scores on the SF-36 health survey showed that, compared to U.S. population means, subjects reported worse physical functioning, more bodily pain, worse general health, worse social functioning, and more emotional-role impairment; self-reported mental health was better than the U.S. population mean. All subjects maintained a belief that they had MCS; 16 (89%) acknowledged that the diagnosis was controversial. It is concluded that the subjects remain strongly committed to their diagnosis of MCS. Most have improved since their original interview, but many remain symptomatic and continue to report ongoing lifestyle changes.

  4. Detailed Follow-up Study of Pediatric Orofacial Granulomatosis Patients.

    Science.gov (United States)

    Haaramo, Anu; Alapulli, Heikki; Aine, Liisa; Saarnisto, Ulla; Tuokkola, Jetta; Ruuska, Tarja; Sipponen, Taina; Pitkäranta, Anne; Kolho, Kaija-Leena

    2017-10-01

    Orofacial granulomatosis (OFG) is a chronic inflammatory condition affecting the orofacial area. Its connection to Crohn disease (CD) is debated. Our aim was to describe a cohort of pediatric patients with OFG in detail, study the long-term behavior of OFG, and evaluate factors predicting CD in patients with OFG. We invited patients diagnosed with OFG at 2 university hospitals, Finland for a follow-up appointment. Patients (n = 29) were examined by a dentist and an otorhinolaryngologist using a structural schema. Orofacial findings were also recorded using digital photographing. Patients filled in questionnaires about general health and special diets. Patients' nutrition was evaluated from food records. The findings were compared between patients with OFG only and OFG with CD. Patients with CD had more findings in the orofacial area (total score for orofacial findings median 11) compared to patients with OFG only (total score median 7.5). There was no statistically significant difference in the type of lesions between these groups, except the upper lip was more often affected in patients with CD (n = 11) than in patients with OFG only (n = 0). Most of the patients had normal otorhinolaryngological findings. All patients with elevated anti-Saccharomyces cerevisiae antibody A levels had CD (n = 6) and they presented with more orofacial findings (total score) than patients with normal levels of anti-S cerevisiae antibody A (P = 0.0311). Long-term follow-up of pediatric-onset patients with OFG shows good prognosis. Patients with OFG do not seem to have otorhinolaryngological comorbidity. Anti-S cerevisiae antibody A may serve as a factor to indicate the possible presence of underlying CD in patients with OFG, but further studies are requested.

  5. 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; Bussmann, Shane; Comerford, Julia M.; Cutri, Roc; Evans, Neal J., II; Griffith, Roger; Jarrett, Thomas; Lake, Sean; Lonsdale, Carol; Rho, Jeonghee; Stanford, S. Adam

    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.

  6. 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.

  7. A follow-up study of hypertensive patients after operative treatment of unilateral renovascular or renal disease

    DEFF Research Database (Denmark)

    McNair, A; Nielsen, M D; Gammelgaard, P A;

    1979-01-01

    years. As a group, the patients had severe hypertension with extensive target organ damage and widespread atherosclerosis. A fairly rigorous selection process was applied, and an unsatisfactory response to medical management was considered a point of major importance. In the majority of cases......A study of 44 hypertensive patients with unilateral renovascular or renal parenchymal disease is presented. All patients underwent corrective surgery. Out of the 44 operated patients, five did not participate in the follow-up examination. The remaining 39 patients constitute the study population....... The effects of surgery on the hypertensive state could be evaluated in 35 patients, whereas four died less than two months after the operation. Follow-up studies were carried out at 8-60 months after the operation. The average period of observation was 32 months; 24 patients were observed for more than two...

  8. Evaluation of safety and efficacy of zonisamide in adult patients with partial, generalized, and combined seizures: an open labeled, noncomparative, observational Indian study

    Directory of Open Access Journals (Sweden)

    Dash A

    2016-02-01

    Full Text Available Amitabh Dash,1 Sangeeta Ravat,2 Avathvadi Venkatesan Srinivasan,3 Ashutosh Shetty,4 Vivek Kumar,5 Renu Achtani,6 Vivek Narain Mathur,7 Boby Varkey Maramattom,8 Veeresh Bajpai,9 Nanjappa C Manjunath,10 Randhi Venkata Narayana,11 Suyog Mehta12 1Eisai Co. Ltd., 2Department of Neurology, Seth GS Medical College & KEM Hospital, Mumbai, 3Department of Neurology, Trinity Acute Care Hospital, Chennai, 4Department of Neurology, Criticare Multispeciality Hospital & Research Centre, Mumbai, 5Department of Neurology, Metro Multispeciality Hospital, Noida, 6Department of Neurology, Mata Chanan Devi Hospital, New Delhi, 7Department of Neurology, Vivekananda Hospital, Hyderabad, 8Department of Neurology, Lourdes Hospital, Kochi, 9Department of Neurology, Sai Neurology Clinic, Lucknow, 10Department of Neurology, Brain and Nerve Care, Bangalore, 11Department of Neurology, Seven Hills Hospital, Visakhapatnam, 12Department of Pharmacology & Therapeutics,Government Medical College, Solapur, India Abstract: A prospective, multicentric, noncomparative open-label observational study was conducted to evaluate the safety and efficacy zonisamide in Indian adult patients for the treatment of partial, generalized, or combined seizures. A total of 655 adult patients with partial, generalized, or combined seizures from 30 centers across India were recruited after initial screening. Patients received 100 mg zonisamide as initiating dose as monotherapy/adjunctive therapy for 24 weeks, with titration of 100 mg every 2 weeks if required. Adverse events, responder rates, and seizure freedom were observed every 4 weeks. Efficacy and safety were also assessed using Clinicians Global Assessment of Response to Therapy and Patients Global Assessment of Tolerability to Therapy, respectively. Follow-up was conducted for a period of 24 weeks after treatment initiation. A total of 655 patients were enrolled and received the treatment and 563 completed the evaluation phase. A total of 20

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

    Science.gov (United States)

    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

    2015-01-01

    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. PMID:26059948

  10. Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial.

    Science.gov (United States)

    Egede, Leonard E; Acierno, Ron; Knapp, Rebecca G; Lejuez, Carl; Hernandez-Tejada, Melba; Payne, Elizabeth H; Frueh, B Christopher

    2015-08-01

    Many older adults with major depression, particularly veterans, do not have access to evidence-based psychotherapy. Telemedicine could increase access to best-practice care for older adults facing barriers of mobility, stigma, and geographical isolation. We aimed to establish non-inferiority of behavioural activation therapy for major depression delivered via telemedicine to same-room care in largely male, older adult veterans. In this randomised, controlled, open-label, non-inferiority trial, we recruited veterans (aged ≥58 years) meeting DSM-IV criteria for major depressive disorder from the Ralph H Johnson Veterans Affairs Medical Center and four associated community outpatient-based clinics in the USA. We excluded actively psychotic or demented people, those with both suicidal ideation and clear intent, and those with substance dependence. The study coordinator randomly assigned participants (1:1; block size 2-6; stratified by race; computer-generated randomisation sequence by RGK) to eight sessions of behavioural activation for depression either via telemedicine or in the same room. The primary outcome was treatment response according to the Geriatric Depression Scale (GDS) and Beck Depression Inventory (BDI; defined as a 50% reduction in symptoms from baseline at 12 months), and Structured Clinical Interview for DSM-IV, clinician version (defined as no longer being diagnosed with major depressive disorder at 12 months follow-up), in the per-protocol population (those who completed at least four treatment sessions and for whom all outcome measurements were done). Those assessing outcomes were masked. The non-inferiority margin was 15%. This trial is registered with ClinicalTrials.gov, number NCT00324701. Between April 1, 2007, and July 31, 2011, we screened 780 patients, and the study coordinator randomly assigned participants to either telemedicine (120 [50%]) or same-room treatment (121 [50%]). We included 100 (83%) patients in the per-protocol analysis in

  11. Multicenter follow-up study of ankle fracture surgery

    Institute of Scientific and Technical Information of China (English)

    XU Hai-lin; WANG Gang; WANG Guang-lin; WU Xin-bao; LIU Li-min; LI Xuan; ZHANG Dian-ying; FU Zhong-guo; WANG Tian-bing; ZHANG Pei-xun; JIANG Bao-guo; SHEN Hui-liang

    2012-01-01

    Background Few data on ankle fractures in China from large multicenter epidemiological and clinical studies are available.The aim of this research was to evaluate the epidemiological features and surgical outcomes of ankle fractures by reviewing 235 patients who underwent ankle fracture surgery at five hospitals in China.Methods This study included patients who underwent ankle fracture surgery at five Chinese hospitals from January 2000 to July 2009.Age,gender,mechanism of injury,Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture type,fracture pattern,length of hospital stay and treatment outcome were recorded.Statistical analyses were conducted using SPSS software.The American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale,visual analogue scale (VAS),and arthritis scale were used to evaluate outcome.Results Of 235 patients with ankle fractures,105 were male with an average age of 37.8 years and 130 were female with an average age of 47.3 years.The average follow-up period was 55.7 months.There were significant differences in the ratios of patients in different age groups between males and females,and in mechanisms of injury among different age groups.There were also significant differences in the length of hospital stay among different fracture types and mechanisms of injury.In healed fractures,the average AOFAS ankle-hindfoot score was 95.5,with an excellence rate of 99.6%,the average VAS score was 0.17,and the average arthritis score was 0.18.Movement of the injured ankle was significantly different to that of the uninjured ankle.There were no significant differences between AO fracture types,fracture patterns or follow-up periods and AOFAS score,but there were some significant differences between these parameters and ankle joint movements,pain VAS score and arthritis score.Conclusions Ankle fractures occur most commonly in middle-aged and young males aged 20-39 years and in elderly females aged 50-69 years.The most common mechanisms of

  12. Long-term follow-up of thyroid nodule growth.

    Science.gov (United States)

    Quadbeck, B; Pruellage, J; Roggenbuck, U; Hirche, H; Janssen, O E; Mann, K; Hoermann, R

    2002-10-01

    Benign thyroid nodules are common in iodine deficient countries. Although many recent studies have addressed the molecular basis and short-term outcome of treatment in nodular thyroid disease, data on the long-term follow-up of thyroid nodule growth are widely lacking. The aim of the present study was to evaluate the long-term behaviour of benign thyroid nodules growth. We followed 109 consecutive patients seen at yearly intervals in our Outpatient Clinic for at least 3 years (range 3-12 years, mean 4.9 +/- 2.6 years) presenting with 139 benign nodules in uni- or multinodular goiters. The size of the nodules and thyroid glands was analysed retrospectively. The study included a spectrum of benign thyroid nodules, 86 functioning and 53 non-functioning. 27 patients were treated with levothyroxine, 8 with iodide and 16 with a combination of both. 58 patients were not treated mainly because of thyroid functional autonomy. Patients with overt hyperthyroidism or suspected malignancy by fine-needle aspiration were excluded from the study. The nodules and glands were assessed by ultrasonography at yearly intervals and documented by photoprints. Relevant growth was defined as an increase in nodule volume of at least 30%. For statistical analyses, Cox Proportional Hazard Model and life-table analyses according to Kaplan-Meier were performed. Most thyroid nodules grew slowly but continuously during follow-up. After about 3 years, half of the nodules had increased their volume by at least 30%. Growth of the nodules was significantly faster than of the corresponding thyroid glands (p < 0.0001). Age and sex of the patients and size or function of the nodules at initial presentation were not significantly related to their growth. Suppression of TSH did not affect growth of the nodules irrespective of the source of thyroid hormones, endogenous or by administration of levothyroxine. In conclusion, benign thyroid nodules have a slow intrinsic growth potential, which is apparently

  13. Congenital hypothyroidism: follow up of a case for 13 years.

    Directory of Open Access Journals (Sweden)

    Sudhir M Naik

    2014-04-01

    Full Text Available Background/objectives: Congenital hypothyroidism is one of the most common preventable causes of mental retardation in children. The prognosis of infants detected by neonatal screening and started on treatment early is excellent, with intelligence quotients similar to sibling or classmate without the disease. Setting: Department of ENT, Head and Neck Surgery, KVG Medical College, Sullia. 1Case report: A 15 year old boy came with history of head ache, generalized body ache and lack of concentration in school. He was a case of congenital hypothyroidism and was on irregular treatment for the last 13 years. Intervention: The patient was advised strictly to continue the oral l-thyroxine 100μg one hour before food and come for regular follow-up. Conclusion: Definite intellectual deterioration is seen if oral l-thyroxine is not started within 50 days of life and the deterioration is irreversible. So in India newborn screening programs should be implemented as a national program as it is very important to diagnose and treatcongenital hypothyroidism as soon as possible and to treat it effectively.

  14. Myxedema madness complicating postoperative follow-up of thyroid cancer.

    Science.gov (United States)

    Morosán Allo, Yanina J; Rosmarin, Melanie; Urrutia, Agustina; Faingold, Maria Cristina; Musso, Carla; Brenta, Gabriela

    2015-08-01

    Although hypothyroidism is associated with an increased prevalence of psychiatric manifestations, myxedema madness is rarely observed. We report the case of a 62-year-old woman with no prior history of psychiatric disorders, who presented to the emergency department with psychomotor agitation 6 weeks after total thyroidectomy for papillary thyroid cancer. Serum thyroid stimulating hormone (TSH) on admission was 62.9 mIU/L and free T4 was madness was considered; hence, antipsychotic drug treatment and intravenous levothyroxine were prescribed. Behavioral symptoms returned to normal within 4 days of presentation, while levels of thyroid hormones attained normal values 1 week after admission. Recombinant TSH (Thyrogen®) was used successfully to prevent new episodes of mania due to thyroid hormone withdrawal in further controls for her thyroid cancer. This case illustrates that myxedema madness can occur in the setting of acute hypothyroidism, completely reverting with levothyroxine and antipsychotic treatment. Recombinant TSH may be a useful tool to prevent myxedema madness or any severe manifestation of levothyroxine withdrawal for the follow-up of thyroid cancer.

  15. Follow-up Sonography after Sonoguided Renal Biopsy

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyung Soo; Park, Cheol Min; Cha, In Ho [Korea University College of Medicine, Seoul (Korea, Republic of)

    1996-06-15

    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

  16. [Follow-up and counselling after pelvic inflammatory disease].

    Science.gov (United States)

    Derniaux, E; Lucereau-Barbier, M; Graesslin, O

    2012-12-01

    Pelvic inflammatory disease (PID) can be responsible for infertility and chronic pelvic pain. Treatment of acute PID is very important as it can reduce the risk of sequelae. However, follow-up, partner treatment and counselling are also useful to reduce the reinfection rate. Few weeks after PID, clinical evaluation as well as transvaginal and transabdominal sonography must be performed. The interest of systematic bacteriological tests is not proved. Hysterosalpingography and second-look laparoscopy should be considered only for women with infertility and severe infection. Use of condom is advisable in this population in order to prevent sexually transmitted diseases (STD) including HIV and to decrease rate of recurrence, associated to contraceptive pill, which is also a good option. In selected cases, intrauterine devices can be used in patients with history of PID if the infection is resolved and no significant risk factors for STD exist. Infertility and chronic pelvic pain are the most common sequelae in the population of young women with severe and recurrent infection. The risk of ectopic pregnancy is higher for these women and must be kept in mind. Counselling and risk-reduction interventions decreased significatively the rate of recurrence and sequelae in PID. Copyright © 2012. Published by Elsevier Masson SAS.

  17. A long-term follow-up of postpartum thyroiditis.

    Science.gov (United States)

    Othman, S; Phillips, D I; Parkes, A B; Richards, C J; Harris, B; Fung, H; Darke, C; John, R; Hall, R; Lazarus, J H

    1990-05-01

    To investigate the long-term outcome of postpartum thyroiditis (PPT), 43 patients with PPT and 171 control women were evaluated 3.5 (range 2-4) years postpartum. Ten (23%) PPT patients were hypothyroid compared to none of the controls (P less than 0.001). Factors associated with the development of hypothyroidism were high antimicrosomal antibody titre measured at 16 weeks gestation (P less than 0.01), severity of hypothyroid phase of PPT, multiparity, and a previous history of spontaneous abortion. The presence of microsomal antibody but no PPT in one pregnancy did not prevent the occurrence of PPT in the next pregnancy in two patients and a further five patients had PPT in two successive pregnancies. There was no association between HLA haplotype, family history of thyroid disease, smoking or frequency of oral contraception, and the development of long-term hypothyroidism after PPT. It is concluded that permanent hypothyroidism is an important sequel to PPT and patients with PPT should be followed up appropriately.

  18. Long-term follow-up of trigonoplasty antireflux operation.

    Science.gov (United States)

    Sharifiaghdas, Farzaneh; Mahmoudnejad, Nastaran; Kashi, Amir H; Ramezani, Mehdi H; Narouie, Behzad

    2017-02-03

    Open trigonoplasty antireflux operation has been associated with promising results. However, its success in controlling reflux has not been evaluated in the long term. All patients who underwent trigonoplasty for vesicoureteral reflux by one surgeon from 2004 to 2014 were included. Preoperative evaluations included direct radionuclide cystography (DRNC) or voiding cystourethrography, urine analysis and culture and abdominal sonography. Urodynamic study and cystoscopy was performed in selected patients. Trigonoplasty was done by a modified Gil-Verent method. The latest available patients' DRNCs were used to judge for reflux relapse. Ninety-one patients, 142 refluxing units; median (range) age, 10.5 (1-45) years; M/F, (11/80) were followed for 18 to 135 months. Reflux resolution rate was 73.6% for patients and 75.4% for refluxing units. Relapse was associated with reflux grade (67% in grade V), ureteral orifice appearance (40% in golf hole/stadium), and patients with a history of pyelonephritis. Multivariable model based on the above variables had less than 10% sensitivity in predicting relapse. Trigonoplasty success rate can decrease with long-term follow-up.

  19. Banked cadaveric fascia lata: 3-year follow-up.

    Science.gov (United States)

    Almeida, S H M; Gregório, E P; Rodrigues, M A F; Grando, J P S; Moreira, H A; Fraga, F C

    2004-05-01

    Autologous fascial and synthetic materials have been widely used to repair the stress form of urinary incontinence (SUI) as well as pelvic floor prolapse. The safety and long-term durability of cadaveric fascia lata in orthopedic and ophthalmologic surgery have encouraged urogynecologists to use this material for a sling material. The rationale of placement of a sling from cadaveric fascia lata is based upon decreasing the complication rates caused by autologous and synthetic materials. However, the high costs of the commercially available tissues in Brazil have limited its use in public health. In our institution we developed a cadaveric fascia lata bank, harvesting the material according to the Brazilian Transplantation Legislation and storing it at -70 degrees C. The safety of the tissue is achieved by 25-kGy irradiation. Since 1999, 30 patients have undergone surgery using material from five donors in repairs for stress urinary incontinence and pelvic floor prolapse at a mean of 34 months' follow-up (ranging from 30 to 40 months), there was no evidence of rejection. Therefore, we have shown the safety of cadaveric fascia lata harvested and treated as described above in our group of patients.

  20. COPD and microalbuminuria: a 12-year follow-up study.

    Science.gov (United States)

    Romundstad, Solfrid; Naustdal, Thor; Romundstad, Pål Richard; Sorger, Hanne; Langhammer, Arnulf

    2014-04-01

    Chronic obstructive pulmonary disease (COPD), low lung function independent of diagnosis and markers of inflammation are all associated with increased morbidity and mortality. Microalbuminuria, reflecting endothelial dysfunction, could be a relevant inflammatory marker of potential systemic effects of COPD. We hypothesised that there was a positive association between microalbuminuria and mortality in individuals with COPD. We conducted a 12-year follow-up study of 3129 participants in the second survey of the Nord-Trøndelag Health Study (HUNT), Norway. At baseline, albuminuria was analysed in three urine samples and spirometry was performed. Among the participants, 136 had COPD and microalbuminuria, defined as a urinary albumin/creatinine ratio between 2.5 and 30.0 mg·mmol(-1). The main outcome measures were hazard ratio of all-cause mortality according to microalbuminuria. Compared to those with COPD without microalbuminuria, the adjusted hazard ratio for all-cause mortality in those with COPD and microalbuminuria was 1.54, 95% CI 1.16-2.04. This result was similar after excluding cardiovascular disease at baseline. Classifying COPD severity by Global Initiative for Chronic Obstructive Lung Disease, there was a positive association trend with increasing severity stages. Microalbuminuria is associated with all-cause mortality in individuals with COPD and could be a relevant tool in identification of patients with poor prognosis.

  1. Follow-up of MARVELS Brown Dwarf Candidates using EXPERT

    Science.gov (United States)

    Ma, Bo; Ge, Jian; Li, Rui; Sithajan, Sirinrat; Thomas, Neil; Wang, Ji; De Lee, Nathan

    2013-02-01

    The SDSS-III MARVELS survey is a comprehensive radial velocity survey of 3,300 nearby F-K stars, between 7.6 < V < 12.0 in 2008-2012. All of the survey data for 2580 FGK stars from the first two and half years have been processed with the latest data pipeline. A total of 26 new brown dwarfs (BD) candidates have been identified in the processed RV data. We expect to have 8 more BD candidates from the ~800 stars currently under processing, which will make a total of 34 BD candidates. This proposal requests KPNO 2.1m telescope time with the EXPERT instrument, to follow up all of these BD candidates to confirm the detections and characterize the orbits. The results will be used to (1) reveal the overall distribution of the new BDs in the parameter space; (2) measure the occurrence rate of BD around FGK type stars; (3) measure dryness of the brown dwarf desert around stars with different mass and metallicity; (4) constrain theoretical models regarding the formation of brown dwarfs; (5) confirm the discovery of `desert in the brown dwarf desert'; (6) identify additional companions associated with the detected systems.

  2. 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.

  3. [Surgery for phimosis with Plastibell. A follow-up study].

    Science.gov (United States)

    Jensen, M K

    1998-06-22

    Fifty-three boys were interviewed 11 years (9-14 years) after an operation for phimosis using the Plastibell technique. The interview concentrated on the cosmetic result, sexual function and late complications. Seventeen patients (31%) experienced cosmetic complications, and 11 patients (21%) claimed to have experienced psycho-social problems due to the appearance of the penis after the operation. Nonetheless an overall of 44 patients (83%) were fully satisfied/satisfied with the cosmetic result. Four patients (8%) claimed to have pain or discomfort on erection or intercourse. One patient (2%) was re-operated three years after the primary operation because of a recurrence of the symptoms. Overall 48 patients (91%) were fully satisfied or satisfied with the result after the operation. In conclusion we find the Plastibell procedure to be a safe and reliable method in treating phimosis. There are some minor technical pitfalls that have to be addressed in learning the technique, but performed in trained hands, the technique offers a very high satisfaction rate at long term follow-up.

  4. 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.

  5. 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.

  6. Intensity of follow-up after pancreatic cancer resection.

    Science.gov (United States)

    Castellanos, Jason A; Merchant, Nipun B

    2014-03-01

    The prognosis of patients diagnosed with pancreatic adenocarcinoma remains dismal. Of the 15-20 % of patients who are candidates for potentially curative resection, 66-92 % will develop recurrent disease. Although guidelines for surveillance in the postoperative setting exist, they are not evidence based, and there is wide variability of strategies utilized. Current surveillance guidelines as suggested by the National Comprehensive Cancer Network (NCCN) include routine history and physical, measurement of serum cancer-associated antigen 19-9 (CA19-9) levels, and computed tomographic imaging at 3- to 6-month intervals for the first 2 years, and annually thereafter. However, the lack of prospective clinical data examining the efficacy of different surveillance strategies has led to a variability of the intensity of follow-up and a lack of consensus on its necessity and efficacy. Recent therapeutic advances may have the potential to significantly alter survival after recurrence, but a careful consideration of current surveillance strategies should be undertaken to optimize existing approaches in the face of high recurrence and low survival rates.

  7. Amantadine augmentation therapy for obsessive compulsive patients resistant to SSRIs-an open-label study.

    Science.gov (United States)

    Stryjer, Rafael; Budnik, Dana; Ebert, Tania; Green, Tamar; Polak, Lea; Weizman, Shira; Spivak, Baruch

    2014-01-01

    It has been hypothesized that glutamatergic dysfunction may play a role in the development of obsessive compulsive disorder (OCD) and that glutamatergic modulation may ameliorate some of the OC symptoms. We evaluated the effectiveness of amantadine (AMN)- a weak, noncompetitive, antagonist of the N-methyl-D-aspartic acid (NMDA) receptor-as an adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs), and its role in improving OC symptoms in cases refractory to SSRI pharmacotherapy alone. Eight patients (5 males and 3 females, aged 42.6 ± 13.1 years) that met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for OCD, scored above 20 points on Yale Brown Obsessive Compulsive Scale (Y-BOCS) and were unresponsive to at least one SSRI, completed an open label study of 6 weeks duration. AMN was added to the current stable SSRI regimen and baseline and endpoint changes in Y-BOCS, depression and anxiety levels were analyzed. Significant reductions in total Y-BOCS (28 ± 4.5 vs. 18.8 ± 8.8; P < 0.01; df = 7; t = 2.36), Y-BOCS compulsion sub-scale (15.3 ± 3.2 vs. 10.6 ± 4.7; P < 0.02; df = 7; t = 2.36), and Y-BOCS obsession sub-scale (12.7 ± 3.3 vs. 8.1 ± 5; P < 0.05; df = 7; t = 2.36) scores were obtained at endpoint. The anxiety and depression levels remained unaltered. AMN adjunction to SSRI treatment may lead to a significant reduction in OC symptoms, supporting the hypothesis that transduction of the glutamate signal via NMDA receptor may play a role in OCD. A large scale, double-blind, placebo-controlled study is warranted to confirm our results.

  8. Dexmedetomidine versus propofol in dilatation and curettage: An open-label pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Priyanka Sethi

    2015-01-01

    Full Text Available Background: Traditionally propofol has been used for providing sedation in dilatation and curettage (D and C. Recently, dexmedetomidine has been tried, but very little evidence exists to support its use. Aims: The aim was to compare hemodynamic and recovery profile of both the drugs along with a degree of comfort experienced by patients and the usefulness of the drug to surgeons. Settings and Design: Tertiary care center and open-label randomized controlled trial. Materials and Methods: Patients posted for D and C were enrolled in two groups (25 each. Both groups received fentanyl 1 μg/kg intravenous (IV at the beginning of the procedure. Group P received IV propofol in dose of 1.5 mg/kg over 10-15 min and Group D received dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by 0.5 μg/kg/h infusion until Ramsay sedation score reached 3-4. Hemodynamic vitals were compared during and after the procedure. In the recovery room time to reach modified Aldrete score (MAS of 9-10 and patient′s and surgeon′s satisfaction scores were also recorded and compared. Results: In Group D, patients had statistically significant lower heart rate at 2, 5, 10 and 15 min as compared to Group P. Hypotension was present in 52% in Group P and 4% in Group D (P < 0.05. MAS of 9-10 was achieved in 4.4 min in subjects in Group D in contrast to 16.2 min in Group P (P < 0.05. Group D showed higher patient and surgeon satisfaction scores (P < 0.05. Conclusion: Dexmedetomidine provide better hemodynamic and recovery profile than propofol. It can be a superior alternative for short surgical day care procedures.

  9. An open-label pilot trial of minocycline in children as a treatment for Angelman syndrome.

    Science.gov (United States)

    Grieco, Joseph C; Ciarlone, Stephanie L; Gieron-Korthals, Maria; Schoenberg, Mike R; Smith, Amanda G; Philpot, Rex M; Heussler, Helen S; Banko, Jessica L; Weeber, Edwin J

    2014-12-10

    Minocycline, a member of the tetracycline family, has a low risk of adverse effects and an ability to improve behavioral performance in humans with cognitive disruption. We performed a single-arm open-label trial in which 25 children diagnosed with Angelman syndrome (AS) were administered minocycline to assess the safety and tolerability of minocycline in this patient population and determine the drug's effect on the cognitive and behavioral manifestations of the disorder. Participants, age 4-12 years old, were randomly selected from a pool of previously screened children for participation in this study. Each child received 3 milligrams of minocycline per kilogram of body weight per day for 8 weeks. Participants were assessed during 3 study visits: baseline, after 8-weeks of minocycline treatment and after an 8-week wash out period. The primary outcome measure was the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III). Secondary outcome measures included the Clinical Global Impressions Scale (CGI), Vineland Adaptive Behavior Scales 2nd Edition (VABS-II), Preschool Language Scale 4th Edition (PLS-IV) and EEG scores. Observations were considered statistically significant if p VABS-II after treatment with minocycline. Finally, mean scores of the BSID-III self-direction subdomain and CGI scale score were significantly improved both after minocycline treatment and after the wash out period. The clinical and neuropsychological measures suggest minocycline was well tolerated and causes improvements in the adaptive behaviors of this sample of children with Angelman syndrome. While the optimal dosage and the effects of long-term use still need to be determined, these findings suggest further investigation into the effect minocycline has on patients with Angelman syndrome is warranted. NCT01531582 - clinicaltrials.gov.

  10. A 10-month, open-label evaluation of desvenlafaxine in Japanese outpatients with major depressive disorder.

    Science.gov (United States)

    Tourian, Karen; Wang, Ying; Ii, Yoichi

    2013-07-01

    The objective of this study was to evaluate the long-term safety of desvenlafaxine for continuation treatment of major depressive disorder (MDD) in Japanese patients. This was a phase 3, multicenter, 10-month, open-label study with flexible dosing of desvenlafaxine (25, 50, 100 mg/day). Japanese patients with MDD who had completed an 8-week, double-blind, placebo-controlled study in which patients received 25 or 50 mg/day desvenlafaxine or placebo were enrolled. In this study, patients received desvenlafaxine 25 mg/day from days 1 to 14, with subsequent upward titration, to a maximum of 100 mg/day, determined by clinical response. Of 304 patients, 75 (24.7%) discontinued during the on-therapy period; patient request was the most common reason (11.5%). Treatment-emergent adverse events were reported by 240 patients (78.9%) during the on-therapy period; the most common adverse events were nasopharyngitis (37.2%), somnolence (11.5%), headache (10.5%), and nausea (10.2%). For the ITT-LOCF population, the mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D₁₇) total score was -4.76 (95% confidence interval: -5.47 to -4.05); continued numerical improvements in the HAM-D₁₇ total scores and other depression outcome measures were observed irrespective of treatment in the previous study. Long-term use of desvenlafaxine was safe and well tolerated, with a clinical benefit/risk profile similar to that in other populations.

  11. Nerve Growth Factor for the Treatment of Spinocerebellar Ataxia Type 3: An Open-label Study

    Institute of Scientific and Technical Information of China (English)

    Song Tan; Rui-Hao Wang; Hui-Xia Niu; Chang-He Shi; Cheng-Yuan Mao; Rui Zhang; Bo Song

    2015-01-01

    Background:Spinocerebellar ataxia type 3 (SCA3) is the most common subtype of SCA worldwide,and runs a slowly progressive and unremitting disease course.There is currently no curable treatment available.Growing evidence has suggested that nerve growth factor (NGF) may have therapeutic effects in neurodegenerative diseases,and possibly also in SCA3.The objective of this study was to test the efficacy of NGF in SCA3 patients.Methods:We performed an open-label prospective study in genetically confirmed adult (>18 years old) SCA3 patients.NGF was administered by intramuscular injection (18 μg once daily) for 28 days consecutively.All the patients were evaluated at baseline and 2 and 4 weeks after treatment using the Chinese version of the scale for assessment and rating of ataxia (SARA).Results:Twenty-one SCA3 patients (10 men and 11 women,mean age 39.14 ± 7.81 years,mean disease duration 4.14 ± 1.90 years,mean CAG repeats number 77.57 ± 2.27) were enrolled.After 28 days of NGF treatment,the mean total SARA score decreased significantly from a baseline of 8.48 ± 2.40 to 6.30 ± 1.87 (P < 0.001).Subsections SARA scores also showed significant improvements in stance (P =0.003),speech (P =0.023),finger chase (P =0.015),fast alternating hand movements (P =0.009),and heel-shin slide (P =0.001).Conclusions:Our preliminary data suggest that NGF may be effective in treating patients with SCA3.

  12. An open-label study of quetiapine in the treatment of fibromyalgia.

    Science.gov (United States)

    Hidalgo, Javier; Rico-Villademoros, Fernando; Calandre, Elena Pita

    2007-01-30

    The aim of this exploratory study was to systematically assess the potential effectiveness and tolerability of quetiapine, an atypical antipsychotic, for the treatment of patients with fibromyalgia. This was a unicentre, open-label study conducted in thirty-five outpatients, 18 years or older, who met the ACR criteria for fibromyalgia and who had not satisfactorily responded to their previous fibromyalgia treatment. Quetiapine, flexibly dosed (25-100 mg/day), was added to their original treatment regimen for 12 weeks. The primary outcome measure was the mean change from baseline to endpoint in the Fibromyalgia Impact Questionnaire (FIQ) total score. Secondary efficacy measures included mean changes from baseline to endpoint in the scores of the Clinical Global Impression (CGI) of Severity scale, Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), 12-Item Short Form Health Survey (SF-12), and individual items of the FIQ. Thirty (85.7%) patients (mean age 47+/-7.9, 93.3% females) had a postbaseline evaluation and constituted the intent-to-treat efficacy sample. Mean FIQ total score decreased significantly by 10.2 points from a baseline of 63.2 to 53.0 at study endpoint (pfatigue subscores but not in FIQ pain subscore. Large effect sizes were observed for the FIQ total (1.04), CGI-severity (1.00) and PSQI (1.07), while moderate effect sizes (i.e.> or =0.50) were encountered in the FIQ fatigue, FIQ stiffness and SF-12 mental component summary. Quetiapine was safely administered and well tolerated. Despite the lack of effect on pain, the significant and relevant improvement in overall efficacy measures and quality of life suggests that quetiapine may be a valuable drug for treatment of patients with fibromyalgia that should be further tested in double-blind, placebo-controlled trials.

  13. 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

  14. The Analysis of two-months effects of muscle stretching. Immediately following injection of methyl prednisolon

    Directory of Open Access Journals (Sweden)

    L. Bidkoli

    2008-01-01

    Full Text Available AbstractBackground and Purpose: Trigger points have been described as causing pain in clinical practice and are a common source of musculoskeletal pain. Trigger point injection can effectively inactivate the trigger points and provide symptomatic relief. Efficacy of injection in the treatment of trigger points depends strongly on the technique of trigger point injection. This study compares muscle stretching immediately after injection of methyl prednisolon vs. injection without stretching in the treatment of trigger points.Materials and Methods: Patients with trigger point pain in the gluteal muscles were recruited using strict inclusion and exclusion criteria from Shiraz Medical School Clinic. Subjects under went two office visits and two phone follow-ups. All patients received injection of lidocaine and methyl prednisolon. In group A, injection was without stretching. In group B, stretching of muscle was done immediately after injection. Evaluation measure tools were 0-10 NRS, VAS and BPI.Results: In respect to VAS, there was a significant statistical difference between both groups one month following injection. In respect to NRS, there was a significant statistical difference between both groups 1 month and 2 months after injection. However, there was no significant statistical difference between both groups in all measurement aspect of BPI, except mood.Conclusion: Muscle stretching immediately after injection was more effective up to two months, than without muscle stretching in the symptomatic treatment of gluteal trigger points.Key words: Trigger points, Stretching, InjectionJ Mazand Univ Med Sci 2008; 18(64: 29-36 (Persian

  15. 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.

  16. Clinical follow up of uniparental disomy 16: First data

    Energy Technology Data Exchange (ETDEWEB)

    Dworniczak, B.; Koppers, B.; Bogdanova, N. [Univ. of Muenster (Germany)] [and others

    1994-09-01

    Following the introduction of the concept of uniparental disomy (UPD) in 1980 by Engel this segregational anomaly is reported in an ever increasing number of patients. So far, several groups of individuals with an increased risk for UPD have been identified including abnormal carriers of familial balanced translocations or centric fusions, carriers of mosaic trisomies, and fetuses after prenatal diagnosis of confined placental mosaicism. A major pathogenetic mechanism appears to be post-meiotic chromosome loss in trisomic conceptuses. UPD was repeatedly observed in the fetus after diagnosis of mosaic or non-mosaic trisomies in the placenta which are usually considered {open_quotes}lethal{close_quotes} (i.e. trisomies 15 and 16). In an ongoing study to determine the incidence and clinical consequences of UPD we investigated the parental origin of chromosomes in the disomic cell line after prenatal diagnosis of mosaicism for various trisomies (e.g. 2, 7, 14, 15, and 16). At present, two maternal disomies 16 and one maternal disomy 15 were identified. Severe intrauterine growth retardation was a common symptome which, however, was also present in some but not all mosaics with a biparental origin of the chromosomes in question. While prognosis is clear in some instances (i.e. UPD 15) counseling can be extremely difficult in others, when imprinting effects and homozygosity for unknown recessive traits present in a parent have to be considered. To assess the clinical significance, detailed follow-up studies of proven cases of uniparental disomies are essential. First data of two cases with UPD 16 are presented.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  18. Cancer mortality among German aircrew: second follow-up.

    Science.gov (United States)

    Zeeb, Hajo; Hammer, Gaël P; Langner, Ingo; Schafft, Thomas; Bennack, Sabrina; Blettner, Maria

    2010-05-01

    Aircrew members are exposed to cosmic radiation and other specific occupational factors. In a previous analysis of a large cohort of German aircrew, no increase in cancer mortality or dose-related effects was observed. In the present study, the follow-up of this cohort of 6,017 cockpit and 20,757 cabin crew members was extended by 6 years to 2003. Among male cockpit crew, the resulting all-cancer standardized mortality ratio (SMR) (n = 127) is 0.6 (95% CI 0.5-0.8), while for brain tumors it is 2.1 (95% CI 1.0-3.9). The cancer risk is significantly raised (RR = 2.2, 95% CI 1.2-4.1) among cockpit crew members employed 30 years or more compared to those employed less than 10 years. Among both female and male cabin crew, the all-cancer SMR and that for most individual cancers are close to 1. The SMR for breast cancer among female crew is 1.2 (95% CI 0.8-1.8). Non-Hodgkin's Lymphoma among male cabin crew is increased (SMR 4.2; 95% CI 1.3-10.8). However, cancers associated with radiation exposure are not raised in the cohort. It is concluded that among cockpit crew cancer mortality is low, particularly for lung cancer. The positive trend of all cancer with duration of employment persists. The increased brain cancer SMR among cockpit crew requires replication in other cohorts. For cabin crew, cancer mortality is generally close to population rates. Cosmic radiation dose estimates will allow more detailed assessments, as will a pooling of updated aircrew studies currently in planning.

  19. [Delirium in elderly inpatients. An 18 month follow-up].

    Science.gov (United States)

    Vázquez, Fernando J; Benchimol, Javier; Giunta, Diego; Cafferata, Carlos; Freixas, Antonio; Vallone, Marcelo; Andresik, Diego; Pollan, Javier; Aprile, Ana; Lorenzo, Jimena; Waisman, Gabriel; Camera, Luis

    2010-01-01

    Delirium usually hardens care during hospitalization and increases morbidity during hospital stay and after discharge. The objective of this study was to describe the prevalence of delirium in elderly inpatients in a Buenos Aires hospital, its morbidity and mortality during hospital stay and the next 18 month follow-up. Patients aged 70 or older admitted to internal medicine unit between September 2005 and May 2006 were enrolled. Delirium was assessed with the Spanish version of Confusion Assessment Method. Demographic data, cause of admition and length of stay, destination after discharge and mortality were registered. A new evaluation was made 18 months after discharge. We evaluated 194 patients and 74 were excluded. Of the 120 included, 52 (43.3%) presented delirium. We found significant differences between patients with and without delirium in previous placement in nursing home (17.3% vs. 1.5%; p < 0.002), dementia (40.4% vs. 8.8%; p < 0.001), median activity of daily living (5 vs. 6; p < 0.001), length-of-stay (7 vs. 5; p = 0.04) and mortality rate (21.2% vs. 1.5%; p < 0.001). Evaluation 18 months later showed differences between patients with and without delirium in median of activity of daily living (1/6 vs. 5/6), patients living in nursing homes (27.5% vs. 7.9%), estimated survival 35.3% (CI 95%: 24-49%) at day 569 and 49% (CI 95%: 32.9-65.4%) at day 644. The difference between survival curves was statistically significant (p = 0.027). Delirium increases morbidity and mortality during hospital stay. Elderly with delirium are at risk of worsening disability and of becoming dependent after discharge and it is a risk factor for higher mortality during the following months after discharge.

  20. Efficacy and safety of tolterodine in subjects with symptoms of overactive bladder: An open label, noncomparative, prospective, multicentric study

    OpenAIRE

    Anant Kumar

    2002-01-01

    Objective: To evaluate the clinical efficacy and safety of Tolterodine 2 mg twice daily in Indian subjects with symptoms of overactive bladder including frequency, ur-gency with or without urge incontinence. Methods: This multicentric open-label, noncompara-tive, prospective study was conducted at 7 centers across India. Eligible patients were assigned to treatment with Tab. Tolterodine 2 mg twice daily for 8 weeks. Subjects were seen at visit ](day 3 to 10), visit 2 (day 1) and after 8...

  1. An open-label,randomized,cross-over bioequivalence study of lafutidine 10 mg under fasting condition

    Institute of Scientific and Technical Information of China (English)

    Bhupesh; Dewan; Raghuram; Chimata

    2010-01-01

    AIM:To assess the relative bioavailability and pharmacokinetic properties of two formulations(test and reference) of Lafutidine 10 mg.METHODS:The study was performed as an open label,randomized,two-way,two-period,two-treatment,single dose cross-over bioequivalence study,under non-fed condition to compare the pharmacokinetic prof iles of the lafutidine formulation manufactured by Emcure Pharmaceuticals Ltd.,India using an indigenously developed active pharmaceutical ingredient(API) and the commercially available Stogra formulation,of UCB Japan Co.,Ltd.,Japan.The two treatments were separated by a washout period of 5 d.After an overnight fasting period of 10 h,the subjects were administered either the test or the reference medication as per the randomization schedule.Blood samples were collected at intervals up to 24 h,as per the approved protocol.Concentrations of lafutidine in plasma were analyzed by a validated liquid chromatography/tandem mass spectrometry(LC/MS/MS) method,and a non-compartmental model was used for pharmacokinetic analysis.The pharmacokinetic parameters were subjected to a 4-way ANOVA accounting for sequence,subjects,period and treatment.Statistical significance was evaluated at 95% conf idence level(P ≥ 0.05).RESULTS:The mean(±SD) values of the pharmacokinetic parameters(test vs reference) were Cmax(265.15±49.84 ng/mL vs 246.79±29.30 ng/mL,P<0.05),Area under the curve(AUC)(0-t)(1033.13±298.74 ng.h/mL vs 952.93±244.07 ng.h/mL,P < 0.05),AUC(0-∞)(1047.61±301.22 ng.h/mL vs 964.21±246.45 ng.h/mL,P<0.05),and tv2(1.92±0.94 h vs 2.05±1.01 h,P<0.05).The 90% conf idence intervals(CI) for the test/reference ratio of mean Cmax,AUC(0-t),and AUC(0-∞) were within the acceptable range of 80.00 to 125.00.The mean times(± SD) to attain maximal plasma concentration(tmax) of lafutidine were 0.95±0.24 h vs 1.01±0.29 h(P<0.05) for the test and the reference formulations respectively.Both the formulations were well tolerated.

  2. Safety of long-term use of linezolid: results of an open-label study

    Directory of Open Access Journals (Sweden)

    Vazquez JA

    2016-09-01

    Full Text Available Jose A Vazquez,1 Anthony C Arnold,2 Robert N Swanson,3 Pinaki Biswas,3 Matteo Bassetti4 1Section of Infectious Diseases, Medical College of Georgia, Georgia Regents University, Augusta, GA, USA; 2UCLA Department of Ophthalmology, Jules Stein Eye Institute, Los Angeles, CA, USA; 3Clinical Research, Global Innovative Pharmaceutical, Pfizer Inc., New York, NY, USA; 4Infectious Diseases Division, Santa Maria della Misericordia University Hospital, Udine, Italy Objective: The objective of this study was to assess the long-term safety of linezolid in patients with chronic infections requiring treatment for ≥6 weeks. Enhanced monitoring for optic neuropathy was included to characterize the early development of this side effect and to identify ophthalmologic tests that might be valuable in early detection of this event. Methods: This was a multicenter, open-label, pilot study of patients aged ≥18 years on long-term linezolid therapy. Matched control patients were included for baseline assessment comparison. Patients were assessed at study entry, monthly while on treatment, at the end of treatment, and 30 days following the last dose. Aggregate ocular safety data were reviewed. Response to treatment was reported. Results: The study was terminated owing to slow enrollment. Twenty-four patients received linezolid; nine patients were included as matched controls. Linezolid was prescribed for a median of 80.5 days (range, 50–254 days. In patients with a reported clinical outcome, the majority were considered improved or cured. Common treatment-related adverse events (AEs included anemia, peripheral neuropathy, polyneuropathy, vomiting, and asthenia, and were consistent with the known safety profile. Most AEs resolved or stabilized with discontinuation of treatment. Results of ophthalmologic tests in the one case adjudicated as probable linezolid-associated optic neuropathy revealed abnormal color vision, characteristic changes in the optic disk

  3. Pattern of follow-up care and early relapse detection in breast cancer patients

    NARCIS (Netherlands)

    Geurts, S.M.E.; Vegt, de F.; Siesling, S.; Flobbe, K.; Aben, K.K.H.; Heiden-van der Loo, van der M.; Verbeek, A.L.M.; Dijck, van J.A.A.M.; Tjan-Heijnen, V.C.G.

    2012-01-01

    Routine breast cancer follow-up aims at detecting second primary breast cancers and loco regional recurrences preclinically. We studied breast cancer follow-up practice and mode of relapse detection during the first 5 years of follow-up to determine the efficiency of the follow-up schedule. The Neth

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

    Science.gov (United States)

    Velasco, Eloisa; Ribera, Mª Victoria; Pi, Joan

    2017-01-01

    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% (pKapandji 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 adverse events (injection site reactions) were reported in four patients (11.4%), and there were no serious or allergic reactions. Conclusion This study suggests that viscosupplementation using NASHA is effective and well tolerated in treating the symptoms of rhizarthrosis. PMID:28392718

  5. Classic high lateral tension and triangular resection methods to prevent dog ear and elongation scar in patients undergoing abdominoplasty: A comparative open-label clinical trial

    Directory of Open Access Journals (Sweden)

    Hossein Abdali

    2017-01-01

    Full Text Available Background: One of the most common operations in the plastic surgery curse is abdominoplasty. Several methods were recommended for achieving better results. In the present study, efficacy of a new method compared with classical high lateral tension on preventing dog ear and elongation scar was evaluated. Materials and Methods: in an open-label, randomized clinical trial, seventy patients who were candidates for abdominoplasty were selected and randomly divided into two groups. The first group was operated by classic high lateral method and the second group was operated by a new method concentrating on changing incision line and angle. Dog ear prevention, length of scar, improvement, and postoperative complications were compared between the two groups. Results: The mean ± standard deviation (SD length of scar in treated patients with classical and new abdominoplasty surgical methods was 53.68 ± 6.34 and 41.71 ± 1.78 cm, respectively, and the length of scar in the group treated with the new method was significantly shorter (P < 0.001. The mean ± SD distance between two anterior superior iliac spine in group treated by new method was significantly decreased after surgery (31.3 ± 1.3 cm compared to before intervention (36.7 ± 3.9 cm (P < 0.01. Conclusion: The new method is more likely to be successful in patients with high lateral tension abdominoplasty. However, according to the lack of similar studies in this regard and the fact that this method was introduced for the first time, it is recommended that further studies in this area are needed and patients in term of complications after surgery need a longer period of follow-up.

  6. Itolizumab in combination with methotrexate modulates active rheumatoid arthritis: safety and efficacy from a phase 2, randomized, open-label, parallel-group, dose-ranging study.

    Science.gov (United States)

    Chopra, Arvind; Chandrashekara, S; Iyer, Rajgopalan; Rajasekhar, Liza; Shetty, Naresh; Veeravalli, Sarathchandra Mouli; Ghosh, Alakendu; Merchant, Mrugank; Oak, Jyotsna; Londhey, Vikram; Barve, Abhijit; Ramakrishnan, M S; Montero, Enrique

    2016-04-01

    The objective of this study was to assess the safety and efficacy of itolizumab with methotrexate in active rheumatoid arthritis (RA) patients who had inadequate response to methotrexate. In this open-label, phase 2 study, 70 patients fulfilling American College of Rheumatology (ACR) criteria and negative for latent tuberculosis were randomized to four arms: 0.2, 0.4, or 0.8 mg/kg itolizumab weekly combined with oral methotrexate, and methotrexate alone (2:2:2:1). Patients were treated for 12 weeks, followed by 12 weeks of methotrexate alone during follow-up. Twelve weeks of itolizumab therapy was well tolerated. Forty-four patients reported adverse events (AEs); except for six severe AEs, all others were mild or moderate. Infusion-related reactions mainly occurred after the first infusion, and none were reported after the 11th infusion. No serum anti-itolizumab antibodies were detected. In the full analysis set, all itolizumab doses showed evidence of efficacy. At 12 weeks, 50 % of the patients achieved ACR20, and 58.3 % moderate or good 28-joint count Disease Activity Score (DAS-28) response; at week 24, these responses were seen in 22 and 31 patients. Significant improvements were seen in Short Form-36 Health Survey and Health Assessment Questionnaire Disability Index scores. Overall, itolizumab in combination with methotrexate was well tolerated and efficacious in RA for 12 weeks, with efficacy persisting for the entire 24-week evaluation period. (Clinical Trial Registry of India, http://ctri.nic.in/Clinicaltrials/login.php , CTRI/2008/091/000295).

  7. Effectiveness and acceptability of accelerated repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depressive disorder: an open label trial.

    Science.gov (United States)

    McGirr, Alexander; Van den Eynde, Frederique; Tovar-Perdomo, Santiago; Fleck, Marcelo P A; Berlim, Marcelo T

    2015-03-01

    Major depressive disorder (MDD) is a significant cause of worldwide disability and treatment resistance is common. High-frequency repetitive transcranial magnetic stimulation (HF-rTMS) has emerged as a treatment for MDD, and while efficacious, the daily commitment for typical 4-6 weeks of treatment poses a significant challenge. We aimed to determine the effectiveness and acceptability of an accelerated rTMS protocol for MDD. In this naturalistic trial, 27 patients with moderate to severe chronic and treatment-resistant MDD were treated with twice-daily HF-rTMS (10 Hz) applied over the left dorsolateral prefrontal cortex for 2 consecutive weeks (60,000 pulses). The primary outcomes were rates of clinical remission and response (16-item Quick Inventory of Depressive Symptomatology post-treatment score ≤ 6, and ≥ 50% reduction, respectively). Secondary outcomes were self-reported anxious symptoms, depressive symptoms and quality of life, and dropout rates as a proxy for acceptability. Ten (37.0%) patients met criteria for clinical remission and 15 (55.6%) were classified as responders, with comparable outcomes for both moderate and severe MDD. Clinician-rated improvements in depressive symptoms were paralleled in self-reported depressive and anxious symptoms, as well as quality of life. No patient discontinued treatment. This study is limited by short treatment duration that might be lengthened with corresponding improvements in effectiveness, limited duration of follow-up, small sample size, and an open-label design requiring randomized controlled replication. An accelerated protocol involving twice-daily sessions of HF-rTMS over the left DLPFC for 2 weeks was effective in treatment-resistant MDD, and had excellent acceptability. Additional research is required to optimize accelerated rTMS treatment protocols and determine efficacy using sham-controlled trials. Copyright © 2014 Elsevier B.V. All rights reserved.

  8. Safety and tolerability of intrathecal delivery of autologous bone marrow nucleated cells in children with cerebral palsy: an open-label phase I trial.

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    Mancías-Guerra, Consuelo; Marroquín-Escamilla, Alma Rosa; González-Llano, Oscar; Villarreal-Martínez, Laura; Jaime-Pérez, José Carlos; García-Rodríguez, Fernando; Valdés-Burnes, Sagrario Lisete; Rodríguez-Romo, Laura Nely; Barrera-Morales, Dinorah Catalina; Sánchez-Hernández, José Javier; Cantú-Rodríguez, Olga Graciela; Gutiérrez-Aguirre, César Homero; Gómez-De León, Andrés; Elizondo-Riojas, Guillermo; Salazar-Riojas, Rosario; Gómez-Almaguer, David

    2014-06-01

    Cerebral palsy (CP) is related to severe perinatal hypoxia with permanent brain damage in nearly 50% of surviving preterm infants. Cell therapy is a potential therapeutic option for CP by several mechanisms, including immunomodulation through cytokine and growth factor secretion. In this phase I open-label clinical trial, 18 pediatric patients with CP were included to assess the safety of autologous bone marrow-derived total nucleated cell (TNC) intrathecal and intravenous injection after stimulation with granulocyte colony-stimulating factor. Motor, cognitive, communication, personal-social and adaptive areas were evaluated at baseline and 1 and 6 months after the procedure through the use of the Battelle Developmental Inventory. Magnetic resonance imaging was performed at baseline and 6 months after therapy. This study was registered in ClinicaTrials.gov (NCT01019733). A median of 13.12 × 10(8) TNCs (range, 4.83-53.87) including 10.02 × 10(6) CD34+ cells (range, 1.02-29.9) in a volume of 7 mL (range, 4-10.5) was infused intrathecally. The remaining cells from the bone marrow aspirate were administered intravenously; 6.01 × 10(8) TNCs (range, 1.36-17.85), with 3.39 × 10(6) cells being CD34+. Early adverse effects included headache, vomiting, fever and stiff neck occurred in three patients. No serious complications were documented. An overall 4.7-month increase in developmental age according to the Battelle Developmental Inventory, including all areas of evaluation, was observed (±SD 2.63). No MRI changes at 6 months of follow-up were found. Subarachnoid placement of autologous bone marrow-derived TNC in children with CP is a safe procedure. The results suggest a possible increase in neurological function. Copyright © 2014 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  9. Cardiovascular risk factors in children after kidney transplantation--from short-term to long-term follow-up.

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    Kaidar, Maital; Berant, Michael; Krauze, Irit; Cleper, Roxana; Mor, Eitan; Bar-Nathan, Nathan; Davidovits, Miriam

    2014-02-01

    Cardiovascular-related mortality is 100-fold higher in pediatric renal transplant recipients than in the age-matched general population. Seventy-seven post-renal transplant children's charts were reviewed for cardiovascular risk factors at two and six months after transplantation (short term) and at two yr after transplantation and the last follow-up visit (mean 7.14 ± 3.5 yr) (long term). Significant reduction was seen in cardiovascular risk factors prevalence from two months after transplantation to last follow-up respectively: Hypertension from 52.1% to 14%, hypercholesterolemia from 48.7% to 33%, hypertriglyceridemia from 50% to 12.5%, anemia from 29.6% to 18.3%, hyperparathyroidism from 32% to 18.3% and hyperglycemia from 11.7% to 10%, and left ventricular hypertrophy from 25.8% at short term to 15%. There was an increase in the prevalence of obesity from 1.5% to 3.9% and of CKD 3-5 from 4.75% to 24%. The need for antihypertensive treatment decreased from 54% to 42%, and the percentage of patients controlled by one medication rose from 26% to 34%, whereas the percentage controlled by 2, 3, and 4 medications decreased from 21.9%, 5.5%, and 1.4% to 6%, 2%, and 0. Children after renal transplantation appear to have high rates of cardiovascular risk factors, mainly on short-term follow-up.

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

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    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.

  11. Long-Term Treatment Outcome in Adult Male Prisoners With Attention-Deficit/Hyperactivity Disorder: Three-Year Naturalistic Follow-Up of a 52-Week Methylphenidate Trial.

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    Ginsberg, Ylva; Långström, Niklas; Larsson, Henrik; Lindefors, Nils

    2015-10-01

    Despite high rates of attention-deficit/hyperactivity disorder (ADHD) among adult lawbreakers, particularly the long-term effects of ADHD pharmacotherapy remain unclear, not the least because of ethical challenges with preventing control subjects in randomized controlled trials from receiving medication over prolonged time. We followed up adult male prisoners with ADHD who completed a 5-week randomized, double-blind, placebo-controlled trial followed by a 47-week open-label extension of osmotic-release oral system methylphenidate in a Swedish high-security prison from 2007 to 2010 (ClinicalTrials.gov: NCT00482313). Twenty-five trial completers were prospectively followed up clinically 1 year (24/25, 96% participated fully or in part) and 3 years (20/25, 80% participation) after trial regarding ADHD symptoms (observer and self-reports), psychosocial functioning, substance misuse, and criminal reoffending. Methylphenidate-related improvements in ADHD symptoms and psychosocial functioning obtained during the 52-week trial were maintained at 1- and 3-year follow-ups. Specifically, after 3 years, 75% (15/20) of the respondents had been released from prison, and 67% of these (10/15) had employment, usually full time. In contrast, nonmedicated respondents at the 3-year follow-up (5/20) reported more ADHD symptoms, functional impairment, and substance misuse compared with currently medicated respondents (15/20). Further, 40% of the respondents self-reported reoffending, indicating a substantially lower relapse rate than expected (70%-80%).In summary, although these observations need validation from new and larger samples, positive effects were maintained after 4 years of methylphenidate treatment. Most study completers were employed and had no relapse in substance misuse or criminality. These results suggest that motivational support and continued medication are important for improved outcome in adult criminal offenders with ADHD.

  12. 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

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    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.

  13. Effectiveness of artemether-lumefantrine provided by community health workers in under-five children with uncomplicated malaria in rural Tanzania: an open label prospective study

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    Blessborn Daniel

    2011-03-01

    Full Text Available Abstract Background Home-management of malaria (HMM strategy improves early access of anti-malarial medicines to high-risk groups in remote areas of sub-Saharan Africa. However, limited data are available on the effectiveness of using artemisinin-based combination therapy (ACT within the HMM strategy. The aim of this study was to assess the effectiveness of artemether-lumefantrine (AL, presently the most favoured ACT in Africa, in under-five children with uncomplicated Plasmodium falciparum malaria in Tanzania, when provided by community health workers (CHWs and administered unsupervised by parents or guardians at home. Methods An open label, single arm prospective study was conducted in two rural villages with high malaria transmission in Kibaha District, Tanzania. Children presenting to CHWs with uncomplicated fever and a positive rapid malaria diagnostic test (RDT were provisionally enrolled and provided AL for unsupervised treatment at home. Patients with microscopy confirmed P. falciparum parasitaemia were definitely enrolled and reviewed weekly by the CHWs during 42 days. Primary outcome measure was PCR corrected parasitological cure rate by day 42, as estimated by Kaplan-Meier survival analysis. This trial is registered with ClinicalTrials.gov, number NCT00454961. Results A total of 244 febrile children were enrolled between March-August 2007. Two patients were lost to follow up on day 14, and one patient withdrew consent on day 21. Some 141/241 (58.5% patients had recurrent infection during follow-up, of whom 14 had recrudescence. The PCR corrected cure rate by day 42 was 93.0% (95% CI 88.3%-95.9%. The median lumefantrine concentration was statistically significantly lower in patients with recrudescence (97 ng/mL [IQR 0-234]; n = 10 compared with reinfections (205 ng/mL [114-390]; n = 92, or no parasite reappearance (217 [121-374] ng/mL; n = 70; p ≤ 0.046. Conclusions Provision of AL by CHWs for unsupervised malaria treatment at home

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

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    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. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study

    Science.gov (United States)

    Fenaux, Pierre; Mufti, Ghulam J; Hellstrom-Lindberg, Eva; Santini, Valeria; Finelli, Carlo; Giagounidis, Aristoteles; Schoch, Robert; Gattermann, Norbert; Sanz, Guillermo; List, Alan; Gore, Steven D; Seymour, John F; Bennett, John M; Byrd, John; Backstrom, Jay; Zimmerman, Linda; McKenzie, David; Beach, C L; Silverman, Lewis R

    2014-01-01

    Summary Background Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens. Methods In a phase III, international, multicentre, controlled, parallel-group, open-label trial, patients with higher-risk myelodysplastic syndromes were randomly assigned one-to-one to receive azacitidine (75 mg/m² per day for 7 days every 28 days) or conventional care (best supportive care, low-dose cytarabine, or intensive chemotherapy as selected by investigators before randomisation). Patients were stratified by French–American–British and international prognostic scoring system classifications; randomisation was done with a block size of four. The primary endpoint was overall survival. Efficacy analyses were by intention to treat for all patients assigned to receive treatment. This study is registered with ClinicalTrials.gov, number NCT00071799. Findings Between Feb 13, 2004, and Aug 7, 2006, 358 patients were randomly assigned to receive azacitidine (n=179) or conventional care regimens (n=179). Four patients in the azacitidine and 14 in the conventional care groups received no study drugs but were included in the intention-to-treat efficacy analysis. After a median follow-up of 21·1 months (IQR 15·1–26·9), median overall survival was 24·5 months (9·9–not reached) for the azacitidine group versus 15·0 months (5·6–24·1) for the conventional care group (hazard ratio 0·58; 95% CI 0·43–0·77; stratified log-rank p=0·0001). At last follow-up, 82 patients in the azacitidine group had died compared with 113 in the conventional care group. At 2 years, on the basis of Kaplan-Meier estimates, 50·8% (95% CI 42·1–58·8) of patients in the azacitidine group were alive compared with 26·2% (18·7–34·3) in the conventional care group (p<0·0001). Peripheral cytopenias were the most

  16. Open-label trial with artemether-lumefantrine against uncomplicated Plasmodium falciparum malaria three years after its broad introduction in Jimma Zone, Ethiopia

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    Eshetu Teferi

    2012-07-01

    Full Text Available Abstract Background In Jimma Zone, Ethiopia, the first-line treatment of uncomplicated falciparum malaria has been changed from sulphadoxine-pyrimethamine (SP to artemether-lumefantrine (AL in 2006. The objective of this study was to assess the effectiveness of AL in Jimma Zone two to three years after its broad introduction. Methods An open-label, single-arm, 42-day study of AL against falciparum malaria was conducted in four areas with moderate transmission in Jimma Zone between November 2008 and January 2009 and between August and December 2009. Patients (one-81 years with uncomplicated Plasmodium falciparum mono-infection were consecutively enrolled. Follow-up visits were at day 2, 3, 7, 28 and 42 or any other day if symptoms reoccurred. Primary and secondary endpoints were PCR-corrected and uncorrected cure rates (molecular differentiation between recrudescence and re-infection on days 28 and 42. Other secondary endpoints were gametocytaemia at day 7 and day 28, parasitaemia at day 2 and 3, and re-infection rates at day 28 and day 42. Results Of 348 enrolled patients, 313 and 301 completed follow-up at day 28 and at day 42, respectively. No early treatment failure occurred. For per protocol analysis, PCR-uncorrected cure rates at day 28 and 42 were 99.1% (95% CI 98.0-100.0 and 91.1% (95% CI 87.9-94.3, respectively. PCR-corrected cure rates at day 28 and 42 were 99.4% (95% CI 98.5-100.0 and 94.7% (95% CI 92.2-97.2, respectively. PCR-corrected cure rate at day 42 for children ≤5 years was 90.6% (95% CI 82.4-98.7 only. Adverse events were in general mild to moderate. Incidence of new infections was 3.4% during 42 days, no new infections with Plasmodium vivax were observed. Microscopically detected gametocytaemia was reduced by 80% between day 0 and day 7. Conclusion In general, AL was effective and well tolerated in Jimma Zone, Ethiopia. However, the PCR-corrected recrudescence rate per-protocol at day 42 for children ≤5 years was

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

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    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

  18. Verteporfin photodynamic therapy combined with intravitreal ranibizumab in neovascular age-related macular degeneration: 24-month follow-up

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    Rosalia Giustolisi

    2014-09-01

    Full Text Available Purpose: to evaluate the efficacy and safety of combined therapy with Photodynamic Therapy with Verteporfin (PDT-V and intravitreal ranibizumab same-day compared with monotherapy with ranibizumab (three monthly injections for the treatment of the choroidal neovascularization (CNV due to age-related macular degeneration (AMD. Type of study : open-label, randomized controlled trial (RCT. Materials and Methods: 17 eyes of 17 patients were consecutively enrolled and randomly assigned to ranibizumab intravitreal injection + PDT compared with a control group of 30 eyes of 30 patients treated with only ranibizumab 0.5mg in three monthly injections. Best corrected visual acuity (BCVA, central macular thickness (CMT on optical coherence tomography were examined before and after treatment. Patients were followed-up for twelve months. Results: in the combined therapy group, the mean baseline BCVA is 32.6 letters, at 24-months after treatment it’s 31.4 letters with a loss of 1.2 letters. The mean central thickness at baseline is 314.6 µm. After twenty four months the mean CMT is 222.5 µm, with mean CMT reduction of 92.1µm. In the ranibizumab-alone group, the mean baseline BCVA is 29.1 letters at 24-months it’s 28.6 letters with a little loss of 0.5 letters. The mean baseline CMT is 297.6 µm, at 24-months it is 235.9 µm, with mean CMT reduction of 61,7µm. Conclusions: the two treatments showed the same efficacy from a functional and anatomic point of view with a less number of retreatments in the combined therapy group. There were no serious ocular adverse events such as retinal detachment, endophthalmitis or ocular hypertone.

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

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    Piccardi, M.; Marangoni, D.; Minnella, A. M.; Savastano, M. C.; Valentini, P.; Ambrosio, L.; Capoluongo, E.; Maccarone, R.; Bisti, S.; Falsini, B.

    2012-01-01

    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. PMID:22852021

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

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    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.

  1. Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol.

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    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 Epilepsy.

  2. A randomized, open-label, controlled trial of gabapentin and phenobarbital in the treatment of alcohol withdrawal.

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    Mariani, John J; Rosenthal, Richard N; Tross, Susan; Singh, Prameet; Anand, Om P

    2006-01-01

    Gabapentin was compared with phenobarbital for the treatment of alcohol withdrawal in a randomized, open-label, controlled trial in 27 inpatients. There were no significant differences in the proportion of treatment completers between treatment groups or the proportion of patients in each group requiring rescue medication for breakthrough signs and symptoms of alcohol withdrawal. There were no significant treatment differences in withdrawal symptoms or psychological distress, nor were there serious adverse events. These findings suggest that gabapentin may be as effective as phenobarbital in the treatment of alcohol withdrawal. Given gabapentin's favorable pharmacokinetic profile, further study of its effectiveness in treating alcohol withdrawal is warranted.

  3. Over 10 years follow-up of Coats' disease in adulthood

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    Otani T

    2011-12-01

    Full Text Available Tatsuro Otani1, Kanako Yasuda1, Naoko Aizawa2, Fumiaki Sakai3, Toru Nakazawa2, Masahiko Shimura11Department of Ophthalmology, NTT East Japan Tohoku Hospital, 2Department of Ophthalmology, Tohoku University School of Medicine, 3Heisei Ophthalmic Associates P.O., Sendai, Miyagi, JapanAbstract: Coats' disease diagnosed in adulthood is rare; therefore, the treatment options and longer clinical course are not well established. We report on two cases of adult onset Coats' disease, which have been observed for more than 10 years after conventional treatment. In the first case, a 76-year-old man with 9 years of diabetic retinopathy noticed a visual field defect in his left eye. Yellowish subretinal exudation with serous retinal detachment in his superior peripheral retina, and telangiectatic vessels with fluorescein leakage, numerous microaneurysms, and areas of capillary nonperfusion observed in a fluorescein angiography indicated adult Coats' disease, and retinal photocoagulation was applied. Within 1 year, subretinal exudation was regressed and visual acuity was improved from 20/50 to 20/20, and was maintained for the next 11 years. In the second case, a 71-year-old man presented with decreased vision in his right eye. The fundus of his right eye showed multiple telangiectasic vessels and subretinal exudates extended to the fovea, which is diagnosed as adult Coats’ disease. Despite retinal photocoagulation, an increase of exudation and an enlargement of retinal detachment was observed within 1 month, and subsequently, additional treatment of cryotherapy was performed. Two months after these therapies, the exudation was regressed without retinal detachment, and visual acuity was improved to 20/200 which was maintained for the next 10 years. Even with adult Coats’ disease, conventional therapies of retinal photocoagulation and cryotherapy are effective and are the initial choice for improving or maintaining visual function.Keywords: adult onset

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

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    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.

  5. Swaddling: Maternal Option and Sleep Behaviour in Two-Month-Old Infants

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    Kelmanson, Igor

    2013-01-01

    This study aimed to assess possible association between swaddling and sleep behaviour in two-month-old infants. It comprised 198 apparently healthy infants from the community setting selected by chance (86 boys, 112 girls), aged two months, who were singletons born in St Petersburg in 2007. The mothers were asked to complete the questionnaires…

  6. Inhaled low-dose iloprost for pulmonary hypertension: a prospective, multicenter, open-label study.

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    Sun, Yun-Juan; Xiong, Chang-Ming; Shan, Guang-Liang; Gu, Qing; Zeng, Wei-Jie; Lu, Xian-Ling; Zhu, Feng; Liu, Zhi-Hong; Ni, Xin-Hai; He, Jian-Guo

    2012-06-01

    Inhaled iloprost (average >30 µg/d) has been considered an effective treatment for severe pulmonary hypertension (PH). Further evidence also showed that low-dose iloprost given intravenously was equally effective as high-dose iloprost in the therapy of systemic sclerosis. Patients with pulmonary hypertension will benefit from inhalation of low-dose iloprost. Sixty-two patients with PH were enrolled and initiated with neubulizedlow-dose iloprost (2.5 µg per inhalation, 6× daily) for 24 weeks in 13 medical centers in China. Efficacy endpoints included changes in 6-minute walk distance (6MWD), World Health Organization functional class (WHO-FC), and hemodynamic parameters. Fourteen patients (22.6%) prematurely discontinued the study: 8 due to clinical worsening (6 in WHO-FCIII-IV at baseline), 4 because of protocol change, and 2 patients lost during follow-up. In the remaining 48 patients, 6MWD was increased from 356 ± 98 meters to 414 ± 99 meters (P iloprost inhalation significantly improved exercise capacity and functional status in patients with PH. It was well tolerated. The improvement of hemodynamics was confirmed in patients with WHO-FCI-II but not in patients with WHO-FCIII-IV, suggesting the importance of early treatment in patients with advanced disease stages. © 2012 Wiley Periodicals, Inc.

  7. 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

    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. 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. 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.

  8. 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.

  9. 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

  10. 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.

  11. Pregabalin augmentation of antidepressants in older patients with comorbid depression and generalized anxiety disorder-an open-label study.

    Science.gov (United States)

    Karaiskos, Dimitrios; Pappa, Dimitra; Tzavellas, Elias; Siarkos, Kostas; Katirtzoglou, Everina; Papadimitriou, George N; Politis, Antonios

    2013-01-01

    The objective of this 12-week open-label study was to evaluate the efficacy, safety, and tolerability of pregabalin as an adjunctive treatment to antidepressants in older patients suffering from depression and comorbid generalized anxiety disorder (GAD). The initial sample of this open-label study consisted of 94 older patients fulfilling criteria for depression with comorbid GAD who were treated with antidepressants. Twenty of them who had received antidepressant monotherapy for an adequate time and shown partial response to the antidepressant prescribed, in terms of either anxiety or depressive symptomatology, followed the next phase. During the 12-week study period, pregabalin was gradually added to the previously prescribed antidepressant, reaching 225 mg/day over 4 weeks. Depression and anxiety scores as well as side effects were monitored. Within groups, differences of depression and anxiety scores at baseline and during the following 12 weeks of treatment were estimated with repeated-measure analysis of variance. A statistical significant reduction in depression scores was observed after the 4th week of treatment (p anxiety scores, a statistically significant improvement was noted between the 2nd and 4th weeks (p anxiety and depressive symptomatology significantly improved, and minimal side effects were observed. Copyright © 2012 John Wiley & Sons, Ltd.

  12. 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

    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 histopatholog......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...... 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...

  13. The IRRS follow-up mission to the Nuclear Safety Council; La mision follow-up de la IRRS al Consejo de Seguridad Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Gurgi Ferrer, A. P.; Collet Campo, D.

    2011-07-01

    The IRRS follow-up mission to the Nuclear Safety Council. From January 25th to February 1st last the CSN headquarters hosted a follow-up to the IAEA Integrated Regulatory Review Service (IRRS) mission carried out in January 2008. The objective of this follow-up has been to check the extent to which the suggestions and recommendations made by the original IRRS mission have been adopted by the audited regulator and, as a result, to verify its degree of adherence to the strictest international standards. (Author)

  14. 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......: This study included an open sample of patients attending routine follow-up at the outpatient Departments of Plastic Surgery and Dermatology, Roskilde Hospital. A total of 218 follow-up patients diagnosed with cutaneous malignant melanoma (MM), non-melanoma skin cancer (NMSC) or actinic keratosis (AK...

  15. Safety and Feasibility of Autologous Mesenchymal Stem Cell Transplantation in Chronic Stroke in Indian patients. A four-year follow up.

    Science.gov (United States)

    Bhasin, Ashu; Kumaran, Senthil S; Bhatia, Rohit; Mohanty, Sujata; Srivastava, M V Padma

    2017-01-01

    Introduction: Stem cell (SC) therapy has been envisioned as a therapeutic vehicle to promote recovery in resistant neurological diseases. Knowing the logistics and paradigms in recovery processes after Stroke, clinicians have pioneered the transplantation therapy. This study presents four-year follow up of our previous trial transplanting bone-marrow-derived animal-free culture expanded intravenous mesenchymal stem cells (MSCs) in chronic stroke which was published in 2010. Methods: We performed an open-label, pilot trial on 12 patients with chronic stroke. Patients were allocated to two groups, those who received intravenous autologous ex vivo cultured mesenchymal stem cells (MSC group) or those who did not (control group), all followed for four years from the day of cell transplantation. Results: The reports have been optimistic regarding safety as we did not find any cell related side effects / mortality till 208th week. We observed that modified Barthel Index showed statistical significant improvement at 156 and 208 weeks of transplantation (95 % CI : -10.27 to 0.07; p =0.041) follow up in the MSC group as compared to controls. The 2nd and 3rd quartile for mBI in MSC group was 89 & 90 respectively suggesting good performance of patients in the stem cell group. The impairment scales i.e., Fugl Meyer, Ashworth tone scale, strength of hand muscles (MRC) did not show any significant improvement at 208th week which is similar to our previous published report. Conclusion: This follow up study primarily indicates safety, tolerance and applicability of autologous mesenchymal stem cells in Stroke. MSCs may act as "chaperones" or work through paracrine mechanisms leading to functional recovery post stroke.

  16. A probiotic treatment containing Lactobacillus, Bifidobacterium and Enterococcus improves IBS symptoms in an open label trial

    Institute of Scientific and Technical Information of China (English)

    FAN Yu-jing; CHEN Shu-jie; YU Ying-cong; SI Jian-min; LIU Bin

    2006-01-01

    Objective: To evaluate the efficacy and safety of live combined Bifidobacterium, Lactobacillus and Enterococcus capsules in treatment of irritable bowel syndrome. Methods: Eighty-five patients [male 32, female 53; age (45.31±11.72) years]were given live combined Bifidobacterium, Lactobacillus and Enterococcus capsules 1260 mg/d t.i.d.×4 weeks. Syndrome scales were used to evaluate the efficacy in gastrointestinal syndrome. Fecal flora was also measured before and after the treatment. Six bacteria were cultured and the colony forming units were counted in stool. SPSS was used for data analysis. Results: Seventy-four patients finished the follow-up. No side-effect was found. For treatment of irritable bowel syndrome, the effective rate of live combined Bifidobacterium, Lactobacillus and Enterococcus capsules was 56.8% in the second week, 74.3% in the fourth week and 73.0% in the sixth week. Single symptom was improved, especially in abdominal pain and stool character. The probiotica containing live combined Bifidobacterium, Lactobacillus and Enterococcus could increase bifidobacterium count (P<0.01) and lactobacillus count (P<0.05); decrease bacteroides count (P<0.05) and enterococci count (P<0.01); No obvious changes were observed in clostridium difficile colonitis and enterobacteriaceae (P>0.05). Conclusion: The result of the study indicated that the administration of live combined Bifidobacterium, Lactobacillus and Enterococcus improved the symptom of irritable bowel syndrome and that there was a gradual increase of this effect. Thereafter conditions remained stable for 2 weeks. That improvement may be associated with alterations in gastrointestinal flora.

  17. Postoperative Follow-up After Bariatric Surgery: Effect on Weight Loss.

    Science.gov (United States)

    Spaniolas, Konstantinos; Kasten, Kevin R; Celio, Adam; Burruss, Matthew B; Pories, Walter J

    2016-04-01

    While adherence to long-term follow-up after bariatric surgery is a mandate for center of excellence certification, the effect of attrition on weight loss is not well understood. The aim of this study was to assess the effect of postoperative follow-up on 12-month weight loss using the Bariatric Outcomes Longitudinal Database (BOLD) dataset. Patients with complete follow-up (3, 6, and 12 months) were compared to patients who had one or more prior missed visits. There were 51,081 patients with 12-month follow-up data available. After controlling for baseline characteristics, complete follow-up was independently associated with excess weight loss ≥50%, and total weight loss ≥30%. Adherence to postoperative follow-up is independently associated with improved 12-month weight loss after bariatric surgery. Bariatric programs should strive to achieve complete follow-up for all patients.

  18. 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

    : This study included an open sample of patients attending routine follow-up at the outpatient Departments of Plastic Surgery and Dermatology, Roskilde Hospital. A total of 218 follow-up patients diagnosed with cutaneous malignant melanoma (MM), non-melanoma skin cancer (NMSC) or actinic keratosis (AK......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......) completed a structured interview. RESULTS: A total of 97% patients found follow-up useful. Continuity and consistency were important. One third of patients felt some degree of pre follow-up anxiety. The number of anxious MM patients was significantly greater than that of NMSC patients. No significant...

  19. An open label prospective randomized trial to compare the efficacy of coal tar-salicylic acid ointment versus calcipotriol/betamethasone dipropionate ointment in the treatment of limited chronic plaque psoriasis

    Directory of Open Access Journals (Sweden)

    Sujay Khandpur

    2014-01-01

    Full Text Available Background: Chronic plaque psoriasis is a common papulosquamous skin disorder, for which a number of topical agents are being used including coal tar, topical steroids and more recently topical calcipotriol/betamethasone dipropionate. There is no study comparing purified coal tar preparation with calcipotriol/betamethasone dipropionate ointment in limited chronic plaque psoriasis. Aims and Objectives: A prospective randomized open label controlled trial to compare the efficacy and safety of topical application of coal tar-salicylic acid ointment with calcipotriol/betamethasone dipropionate ointment applied once at night for 12 weeks for the treatment of limited chronic plaque psoriasis. Materials and Methods: A total of 62 patients of limited chronic plaque psoriasis (body surface area <10% were randomized into two treatment groups: Group A received topical application of 6% coal tar with 3% salicylic acid ointment and Group B received calcipotriol/betamethasone dipropionate, once at night for 12 weeks. Results were assessed based on psoriasis area severity index (PASI scores and patient global assessment (PGA at each visit. Results: Mean PASI was significantly lower at week 2 (P = 0.01 and week 4 follow-up (P = 0.05 and the mean reduction in PASI was significantly higher at week 2 (P = 0.02 with calcipotriol/betamethasone than coal tar-salicylic acid, but this difference was not sustained at subsequent follow-up visits. Similarly, PGA scores at weeks 2 and 4 were significantly lower with calcipotriol/betamethasone dipropionate ointment (P = 0.003 and P = 0.007 respectively. There was no significant difference in any parameter during subsequent follow-up visits or at the end of the treatment phase (12 weeks. Conclusion: Topical nightly application of calcipotriol/betamethasone dipropionate ointment leads to an initial, more rapid reduction in disease severity, but the overall outcome parameters are comparable in the two treatment groups.

  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. Patients lost to follow-up in acromegaly: results of the ACROSPECT study.

    Science.gov (United States)

    Delemer, B; Chanson, Ph; Foubert, L; Borson-Chazot, F; Chabre, O; Tabarin, A; Weryha, G; Cortet-Rudelli, C; Raingeard, I; Reznik, Y; Reines, C; Bisot-Locard, S; Castinetti, F

    2014-05-01

    The complex management of acromegaly has transformed this disease into a chronic condition, with the risk of patients being lost to follow-up. The objective of this study was to estimate the proportion of acromegalic patients lost to follow-up in France and to determine the impact that abandoning follow-up has on the disease and its management. ACROSPECT was a French national, multicentre, cross-sectional, observational study. Acromegalic patients were considered lost to follow-up if no new information had been entered in their hospital records during the previous 2 years. They were traced where possible, and data were collected by means of a recall visit or questionnaire. In the study population, 21% of the 2392 acromegalic patients initially followed in 25 tertiary endocrinology centres were lost to follow-up. At their last follow-up visit, 30% were uncontrolled, 33% were receiving medical therapy and 53% had residual tumour. Of the 362 traced, 62 had died and 77% were receiving follow-up elsewhere; the leading reason for abandoning follow-up was that they had not been informed that it was necessary. Our analysis of the questionnaires suggests that they were not receiving optimal follow-up. This study underlines the need to better inform acromegalic patients of the need for long-term follow-up, the absence of which could be detrimental to patients' health, and to develop shared care for what must now be regarded as a chronic disease.

  2. 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.)

  3. 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

  4. Efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren contracture: short-term results from 2 open-label studies.

    Science.gov (United States)

    Witthaut, Jörg; Jones, Graeme; Skrepnik, Nebojsa; Kushner, Harvey; Houston, Anthony; Lindau, Tommy R

    2013-01-01

    The JOINT I (United States) and JOINT II (Australia and Europe) studies evaluated the efficacy and safety of collagenase clostridium histolyticum (CCH) injection for the treatment of Dupuytren contracture. Both studies used identical open-label protocols. Patients with fixed-flexion contractures of metacarpophalangeal (MCP) (20° to 100°) or proximal interphalangeal (PIP) joints (20° to 80°) could receive up to three 0.58-mg CCH injections per cord (up to 5 total injections per patient). We performed standardized finger extension procedures to disrupt injected cords the next day, with follow-up 1, 2, 6, and 9 months thereafter. The primary end point (clinical success) was reduction in contracture to within 0° to 5° of full extension 30 days after the last injection. Clinical improvement was defined as 50% or more reduction from baseline contracture. Dupuytren cords affecting 879 joints (531 MCP and 348 PIP) in 587 patients were administered CCH injections at 14 U.S. and 20 Australian/European sites, with similar outcomes in both studies. Clinical success was achieved in 497 (57%) of treated joints using 1.2 ± 0.5 (mean ± SD) CCH injections per cord. More MCP than PIP joints achieved clinical success (70% and 37%, respectively) or clinical improvement (89% and 58%, respectively). Less severely contracted joints responded better than those more severely contracted. Mean change in contracture was 55° for MCP joints and 25° for PIP joints. With average contracture reductions of 73% and improvements in range of motion by 30°, most patients (92%) were "very satisfied" (71%) or "quite satisfied" (21%) with treatment. Physicians rated change from baseline as "very much improved" (47%) or "much improved" (35%). The CCH injections were well tolerated, causing no tendon ruptures or systemic reactions. Collagenase clostridium histolyticum was an effective, minimally invasive option for the treatment of Dupuytren contracture of a broad range of severities. Most

  5. Symptomatic or prophylactic treatment of weekend migraine: an open-label, nonrandomized, comparison study of frovatriptan versus naproxen sodium versus no therapy

    Directory of Open Access Journals (Sweden)

    Guidotti M

    2013-01-01

    Full Text Available Mario Guidotti,1 Caterina Barrilà,1 Serena Leva,1 Claudio De Piazza,1 Stefano Omboni21Department of Neurology, Valduce Hospital, Como, 2Italian Institute of Telemedicine, Varese, ItalyBackground: Migraine often occurs during weekends. The efficacy of frovatriptan, naproxen sodium, or no therapy for the acute or prophylactic treatment of weekend migraineurs was tested in an open-label, nonrandomized pilot study.Methods: Twenty-eight subjects (mean age 36 ± 12 years, including 18 females suffering from migraine without aura were followed up for six consecutive weekends. No treatment was administered during the first two weekends. On the third and fourth weekends, patients were given frovatriptan 2.5 mg and on the fifth and sixth weekends naproxen sodium 500 mg. Treatment was taken on Saturday and Sunday morning, regardless of the occurrence of migraine. Efficacy was evaluated through a diary, where patients reported the severity of migraine on a scale from 0 (no migraine to 10 (severe migraine and use of rescue medication.Results: The migraine severity score was significantly lower with frovatriptan (4.8 [95% confidence interval (CI 3.8–5.9] than with naproxen sodium (5.7 [CI 5.1–6.4], P < 0.05 versus frovatriptan or no therapy (6.6 [6.2–7.0], P < 0.01 versus frovatriptan. The difference in favor of frovatriptan was more striking in patients not taking rescue medication (frovatriptan, 1.9 [1.5–2.3] versus naproxen sodium 3.6 [3.0–4.2], P < 0.001 and versus no therapy (5.1 [4.4–5.8], P < 0.001 and on the second day of treatment. The rate of use of rescue medication was significantly (P < 0.05 lower on frovatriptan (12.5% than on naproxen sodium (31.3% or no therapy (56.3%.Conclusion: This pilot study provides the first evidence of the efficacy of a second-generation triptan as symptomatic or prophylactic treatment for weekend migraine.Keywords: migraine, frovatriptan, naproxen sodium, weekend

  6. Comparison of Doxycycline, Minocycline, Doxycycline plus Albendazole and Albendazole Alone in Their Efficacy against Onchocerciasis in a Randomized, Open-Label, Pilot Trial

    Science.gov (United States)

    Batsa, Linda; Ayisi-Boateng, Nana Kwame; Osei-Mensah, Jubin; Mubarik, Yusif; Konadu, Peter; Ricchiuto, Arcangelo; Fimmers, Rolf; Arriens, Sandra; Dubben, Bettina; Ford, Louise; Taylor, Mark; Hoerauf, Achim

    2017-01-01

    The search for new macrofilaricidal drugs against onchocerciasis that can be administered in shorter regimens than required for doxycycline (DOX, 200mg/d given for 4–6 weeks), identified minocycline (MIN) with superior efficacy to DOX. Further reduction in the treatment regimen may be achieved with co-administration with standard anti-filarial drugs. Therefore a randomized, open-label, pilot trial was carried out in an area in Ghana endemic for onchocerciasis, comprising 5 different regimens: the standard regimen DOX 200mg/d for 4 weeks (DOX 4w, N = 33), the experimental regimens MIN 200mg/d for 3 weeks (MIN 3w; N = 30), DOX 200mg/d for 3 weeks plus albendazole (ALB) 800mg/d for 3 days (DOX 3w + ALB 3d, N = 32), DOX 200mg/d for 3 weeks (DOX 3w, N = 31) and ALB 800mg for 3 days (ALB 3d, N = 30). Out of 158 randomized participants, 116 (74.4%) were present for the follow-up at 6 months of whom 99 participants (63.5%) followed the treatment per protocol and underwent surgery. Histological analysis of the adult worms in the extirpated nodules revealed absence of Wolbachia in 98.8% (DOX 4w), 81.4% (DOX 3w + ALB 3d), 72.7% (MIN 3w), 64.1% (DOX 3w) and 35.2% (ALB 3d) of the female worms. All 4 treatment regimens showed superiority to ALB 3d (p < 0.001, p < 0.001, p = 0.002, p = 0.008, respectively), which was confirmed by real-time PCR. Additionally, DOX 4w showed superiority to all other treatment arms. Furthermore DOX 4w and DOX 3w + ALB 3d showed a higher amount of female worms with degenerated embryogenesis compared to ALB 3d (p = 0.028, p = 0.042, respectively). These results confirm earlier studies that DOX 4w is sufficient for Wolbachia depletion and the desired parasitological effects. The data further suggest that there is an additive effect of ALB (3 days) on top of that of DOX alone, and that MIN shows a trend for stronger potency than DOX. These latter two results are preliminary and need confirmation in a fully randomized controlled phase 2 trial. Trial

  7. Randomized open-label phase II study comparing oxycodone-naloxone with oxycodone in early return of gastrointestinal function after laparoscopic colorectal surgery.

    Science.gov (United States)

    Creamer, F; Balfour, A; Nimmo, S; Foo, I; Norrie, J D; Williams, L J; Fearon, K C; Paterson, H M

    2017-01-01

    Combined oral modified-release oxycodone-naloxone may reduce opioid-induced postoperative gut dysfunction. This study examined the feasibility of a randomized trial of oxycodone-naloxone within the context of enhanced recovery for laparoscopic colorectal resection. In a single-centre open-label phase II feasibility study, patients received analgesia based on either oxycodone-naloxone or oxycodone. Primary endpoints were recruitment, retention and protocol compliance. Secondary endpoints included a composite endpoint of gut function (tolerance of solid food, low nausea/vomiting score, passage of flatus or faeces). Eighty-two patients were screened and 62 randomized (76 per cent); the attrition rate was 19 per cent (12 of 62), leaving 50 patients who received the allocated intervention with 100 per cent follow-up and retention (modified intention-to-treat cohort). Protocol compliance was more than 90 per cent. Return of gut function by day 3 was similar in the two groups: 13 (48 per cent) of 27 in the oxycodone-naloxone group and 15 (65 per cent) of 23 in the control group (95 per cent c.i. for difference -10·0 to 40·7 per cent; P = 0·264). However, patients in the oxycodone-naloxone group had a shorter time to first bowel movement (mean(s.d.) 87(38) h versus 111(37) h in the control group; 95 per cent c.i. for difference 2·3 to 45·4 h, P = 0·031) and reduced total (oral plus parenteral) opioid consumption (mean(s.d.) 78(36) versus 94(56) mg respectively; 95 per cent c.i. for difference -10·2 to 42·8 mg, P = 0·222). High participation, retention and protocol compliance confirmed feasibility. Potential benefits of oxycodone-naloxone in reducing time to bowel movement and total opioid consumption could be tested in a randomized trial. Registration number: NCT02109640 (https://www.clinicaltrials.gov/). © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

  8. Long-term efficacy and tolerability of a fixed-dose combination of antihypertensive agents: an open-label surveillance study in China.

    Science.gov (United States)

    Wu, Yiqun; Hu, Yonghua; Tang, Xun; He, Liu; Ren, Tao; Tao, Qiushan; Qin, Xueying; Sun, Ningling; Wang, Hongyi; Cao, Weihua; Wu, Tao; Zhan, Siyan; Wang, Jin; Chen, Weihua; Li, Liming

    2011-11-01

    A fixed-dose combination (FDC) of four compounds, hydrochlorothiazide 12.5 mg, triamterene 12.5 mg, dihydralazine 12.5 mg and reserpine 0.1 mg (HTDR), is widely used as an antihypertensive treatment in China. Although HTDR has been used in China for more than 30 years, there have been few comprehensive evaluations of this treatment. The aim of this study was to investigate the long-term efficacy and tolerability of HTDR in Chinese patients with essential hypertension. This was a 36-month, community-based, open-label surveillance study, conducted in the Huangpu District (Shanghai, China). The study was based in local primary healthcare settings. Subjects were recruited if they had essential hypertension, were aged ≥35 years at the time of enrolment, were expected to remain in the area for 3 years, and were able to provide informed consent. Patients who had secondary hypertension, myocardial infarction or stroke within 6 months of screening, impaired renal or hepatic function, history of cardiomyopathy or chronic heart failure, or were pregnant or lactating were excluded. HTDR was administered as one or two tablets per day in the morning. If necessary, additional hydrochlorothiazide was added. Blood pressure (BP) was measured at baseline and throughout the 36-month surveillance period every 3 months. Biochemical indicators (e.g. fasting blood glucose, plasma lipid parameters, plasma sodium and potassium, plasma uric acid and serum creatinine) were also measured, and adverse events were noted. BP reductions and the rate at which patients achieved BP targets (systolic BP [SBP] treatment period, 93.1% of patients had achieved the SBP target, 97.9% had achieved the DBP target, and 92.1% had achieved both. The mean decreases in SBP and DBP were 15.3 mmHg and 9.9 mmHg, respectively. Overall, 127 adverse events in 119 patients (7.8%) occurred during the follow-up period, most of which were mild to moderate. Plasma lipid profiles were improved after 24 months of treatment

  9. Intravenous pamidronate versus oral and intravenous clodronate in bone metastatic breast cancer: a randomized, open-label, non-inferiority Phase III trial

    Directory of Open Access Journals (Sweden)

    von Au A

    2016-07-01

    Full Text Available Alexandra von Au,1 Eva Milloth,1 Ingo Diel,2 Stefan Stefanovic,1 Andre Hennigs,1 Markus Wallwiener,1 Joerg Heil,1 Michael Golatta,1 Joachim Rom,1 Christof Sohn,1 Andreas Schneeweiss,1 Florian Schuetz,1 Christoph Domschke1 1Breast Unit, Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, 2CGG Clinic – Centrum für ganzheitliche Gynäkologie Mannheim, Mannheim, Germany Purpose: Patients with metastasized breast cancer often suffer from discomfort caused by metastatic bone disease. Thus, osteoprotection is an important part of therapy in breast cancer metastasized to bone, and bisphosphonates (BPs are a major therapeutic option. In this study, our objectives were to compare the side effects of oral versus intravenous BP treatment and to assess their clinical effectiveness.  Patients and methods: In this prospective randomized, open-label, non-inferiority trial, we enrolled breast cancer patients with at least one bone metastasis and an Eastern Cooperative Oncology Group performance status of 0–2. Patients were randomly assigned to one of the three treatment groups: A, 60 mg pamidronate intravenously q3w; B-iv, 900 mg clodronate intravenously q3w; and B-o, 2,400 mg oral clodronate daily. Assessments were performed at baseline and every 3 months thereafter.  Results: Between 1995 and 1999, 321 patients with confirmed bone metastases from breast cancer were included in the study. At first follow-up, gastrointestinal (GI tract side effects were most common, and adverse effects on the GI tract were more frequent in the oral treatment group (P=0.002 and P<0.001, respectively. There were no statistically significant differences among the treatment cohorts for other documented side effects (skin, serum electrolytes, urinary tract, immune system, and others. No significant differences in clinical effectiveness of BP treatment, as assessed by pain score, were detected among the groups; however, pathologic fractures

  10. Early versus deferred antiretroviral therapy for children older than 1 year infected with HIV (PREDICT): a multicentre, randomised, open-label trial

    Science.gov (United States)

    Puthanakit, Thanyawee; Vonthanak, Saphonn; Ananworanich, Jintanat; Kosalaraksa, Pope; Hansudewechakul, Rawiwan; Vibol, Ung; Kerr, Stephen J.; Kanjanavanit, Suparat; Ngampiyaskul, Chaiwat; Wongsawat, Jurai; Luesomboon, Wicharn; Ngo-Giang-Huong, Nicole; Chettra, Kea; Cheunyam, Theshinee; Suwarnlerk, Tulathip; Ubolyam, Sasiwimol; Shearer, William T.; Paul, Robert; Mofenson, Lynne M.; Fox, Lawrence; Law, Matthew G.; Cooper, David A.; Phanuphak, Praphan; Vun, Mean Chhi; Ruxrungtham, Kiat

    2012-01-01

    Summary Background The optimum time to start antiretroviral therapy for children diagnosed with HIV infection after 1 year of age is unknown. We assessed whether antiretroviral therapy could be deferred until CD4 percentages declined to less than 15% without affecting AIDS-free survival. Methods In our multicentre, randomised, open-label trial at nine research sites in Thailand and Cambodia, we enrolled children aged 1–12 years who were infected with HIV and had CD4 percentages of 15–24%. Participants were randomly assigned (1:1) by a minimisation scheme to start antiretroviral therapy at study entry (early treatment group) or antiretroviral therapy to start when CD4 percentages declined to less than 15% (deferred treatment group). The primary endpoint was AIDS-free survival (based on US Centers for Disease Control and Prevention category C events) at week 144, assessed with the Kaplan-Meier analysis and the log-rank approach. This study is registered with ClinicalTrials.gov, number NCT00234091. Findings Between March 28, 2006, and Sept 10, 2008, we enrolled 300 Thai and Cambodian children infected with HIV, with a median age of 6·4 years (IQR 3·9–8·4). 150 children were randomly allocated early antiretroviral therapy (one participant was excluded from analyses after withdrawing before week 0) and 150 children were randomly allocated deferred antiretroviral therapy. Median baseline CD4 percentage was 19% (16–22%). 69 children (46%) in the deferred treatment group started antiretroviral therapy during the study. AIDS-free survival at week 144 in the deferred treatment group was 98·7% (95% CI 94·7–99·7; 148 of 150 patients) compared with 97·9% (93·7–99·3; 146 of 149 patients) in the early treatment group (p=0·6). Interpretation AIDS-free survival in both treatment groups was high. This low event rate meant that our study was underpowered to detect differences between treatment start times and thus additional follow-up of study participants or

  11. Rifaximin Is Effective for the Treatment of Clostridium difficile—Associated Diarrhea: Results of an Open-Label Pilot Study

    Directory of Open Access Journals (Sweden)

    David T. Rubin

    2011-01-01

    Full Text Available Objectives. This open-label trial assessed the efficacy and safety of rifaximin as first-line therapy in hospitalized patients with Clostridium difficile-associated diarrhea (CDAD. Methods. We enrolled thirteen patients who had a confirmed diagnosis of CDAD characterized by ≥3 unformed stools/day and positive C. difficile toxin assay. Those patients received rifaximin 400 mg three times daily for 10 days. Resolution of symptoms, repeat assay 10 days after treatment, and followup for recurrence were assessed. Results. Eight patients completed the study, and all reported symptom resolution during treatment. Mean time to last unformed stool was 132 h ± 42.5 h. Seven patients had no relapse by week 2 and in longer followup (median 162 days. One patient had recurrent CDAD during a repeat hospitalization. Conclusions. Rifaximin was effective and safe as first-line treatment for CDAD and did not result in recurrence in most patients.

  12. The effects of amisulpride on five dimensions of psychopathology in patients with schizophrenia: a prospective open- label study

    Directory of Open Access Journals (Sweden)

    Fresan Ana

    2005-05-01

    Full Text Available Abstract Background The efficacy of antipsychotics can be evaluated using the dimensional models of schizophrenic symptoms. The D2/D3-selective antagonist amisulpride has shown similar efficacy and tolerability to other atypical antipsychotics. The aim of the present study was to determine the efficacy of amisulpride on the dimensional model of schizophrenic symptoms and tolerability in latin schizophrenic patients. Method Eighty schizophrenic patients were enrolled and 70 completed a prospective open-label 3-month study with amisulpride. The schizophrenic symptoms, psychosocial functioning and side-effects were evaluated with standardized scales. Results The patients showed significant improvement in the five dimensions evaluated. Amisulpride (median final dose 357.1 mg/d was well-tolerated without treatment-emergent extrapyramidal side-effects. Conclusion Amisulpride showed efficacy on different psychopathological dimensions and was well tolerated, leading to consider this drug a first line choice for the treatment of schizophrenia.

  13. Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder

    Directory of Open Access Journals (Sweden)

    Berman R

    2011-05-01

    Full Text Available Robert M Berman1, Michael E Thase2, Madhukar H Trivedi3, James A Hazel4, Sabrina Vogel Marler5, Robert D McQuade6, William Carson7, Ross A Baker8, Ronald N Marcus91Neuroscience Global Clinical Research Bristol-Myers Squibb, Wallingford, CT, USA; 2Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, USA; 3Division of Mood Disorders Research Program and Clinic, University of Texas Southwestern Medical School, Dallas, TX, USA; 4Neuroscience Global Clinical Research, Bristol-Myers Squibb, Wallingford, CT, USA; 5Global Biometric Sciences, Bristol-Myers Squibb, Wallingford, CT, USA; 6Global Medical Affairs at Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 7Global Clinical Development, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, NJ, USA; 8Neuroscience Medical Strategy, Bristol-Myers Squibb Company, Plainsboro, NJ, USA; 9Neuroscience Global Clinical Research, Bristol-Myers Squibb, Wallingford, CT, USABackground: Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting.Patients and methods: Patients (n = 706 completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296 nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received open-label aripiprazole for up to 52 weeks.Results: Open-label treatment was completed by 323 patients (32.2%. At endpoint (n = 987, the mean dose of aripiprazole was 10.1 mg/day. Common (>15% of patients spontaneously reported adverse events were akathisia (26.2%, fatigue (18.0%, and weight gain (17.1%. The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%; all resolved within 45 days of drug

  14. Topical tretinoin 0.1% for pregnancy-related abdominal striae: an open-label, multicenter, prospective study.

    Science.gov (United States)

    Rangel, O; Arias, I; García, E; Lopez-Padilla, S

    2001-01-01

    In an open-label, multicenter, prospective study, 20 women applied tretinoin (retinoic acid) cream 0.1% daily for 3 months to pregnancy-related stretch marks in the abdominal area. Efficacy was evaluated by analysis of one preselected target lesion, which was rated on a six-point scale (-1 = worse to 4 = cleared). At week 12, significant global improvement was noted from baseline in all stretch marks, and the target lesion decreased in length by 20% (P = .01). Erythema and scaling, the most common adverse events, occurred in 11 patients, decreased in severity after the first month of treatment, and were controlled with continued application of tretinoin and petroleum jelly ointment. In this small study, topical application of tretinoin significantly improved the clinical appearance of pregnancy-related stretch marks.

  15. Comparison of remote and in-clinic follow-up after methotrexate/misoprostol abortion.

    Science.gov (United States)

    Dunn, Sheila; Panjwani, Dilzayn; Gupta, Melini; Meaney, Christopher; Morgan, Rebecca; Feuerstein, Erika

    2015-09-01

    This study compared adherence to follow-up and clinical outcomes between standard in-clinic and remote follow-up after methotrexate/misoprostol abortion. This nonrandomized trial recruited women requesting medical abortion at two sexual health clinics in Toronto, Canada. Women received methotrexate 50 mg/m(2) followed 3-7 days later by 800 mcg of misoprostol self-administered vaginally. For Day 15, follow-up participants could choose standard in-clinic follow-up with ultrasound and assessment or remote telephone follow-up with serum β-hCG performed at a community laboratory and symptom checklist. Standard and remote follow-up groups were compared for adherence, defined as completing follow-up within 7 days of the scheduled time, and clinical outcomes. Characteristics associated with adherence were assessed using multivariable logistic regression. Of 129 women, 86 (67%) chose remote follow-up. Nonadherence rates for remote (28%) and standard (23%) follow-up groups did not differ in univariate (p=.57) or multivariable analysis (odds ratio: 1.09, 95% confidence interval: 0.39-3.01). Rates of emergency/hospital visits were 3% and 9% for remote and standard groups, respectively (p=.22), and complete loss to follow was 6% and 14% in remote and standard groups (p=.18). Nonadherent women were more likely to be undecided about their contraception (65% vs. 28%; p=.002), and this difference persisted in the multivariable analysis. Given a choice of remote or in-clinic follow-up after methotrexate/misoprostol abortion, most women chose remote follow-up. Rates of adherence to follow-up, adverse outcomes and complete loss to follow-up were similar for women choosing remote and standard follow-up. Since standard and remote follow-up after methotrexate/misoprostol abortion are associated with similar adherence to follow-up and similar safety profiles, women should be offered their choice of follow-up method. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Mindfulness Meditation and CBT for Insomnia: A Naturalistic 12-Month Follow-up

    OpenAIRE

    Ong, Jason C.; Shapiro, Shauna L.; Manber, Rachel

    2009-01-01

    A unique intervention combining mindfulness meditation with cognitive behavioral therapy for insomnia (CBT-I) has been shown to have acute benefits at post-treatment in an open label study. The aim of the present study was to examine the long-term effects of this integrated intervention on measures of sleep and sleep-related distress in an attempt to characterize the natural course of insomnia following this treatment and to identify predictors of poor long-term outcome. Analyses were conduct...

  17. Escitalopram in the treatment of patients with schizophrenia and obsessive-compulsive disorder: an open-label, prospective study.

    Science.gov (United States)

    Stryjer, Rafael; Dambinsky, Yael; Timinsky, Igor; Green, Tamar; Kotler, Moshe; Weizman, Abraham; Spivak, Baruch

    2013-03-01

    The current data suggest that up to 50% of patients with schizophrenia have obsessive-compulsive (OC) symptoms coexisting with psychosis and between 7.8 and 46% of schizophrenia patients also have full-blown obsessive-compulsive disorder (OCD). The aim of this study was to examine the efficacy of the most selective serotonin reuptake inhibitor escitalopram in the management of OCD in schizophrenia patients. The study was an open-label prospective trial of 12 weeks' duration in which escitalopram at a dose of up to 20 mg/day was added to the existing antipsychotic drug regimen in schizophrenia patients with OCD. Fifteen patients (10 men/five women) with the diagnosis of schizophrenia and OCD were recruited for the study (mean age: 39±14, range 21-61 years) and received escitalopram according to the study design. A significant improvement was observed in the total Yale Brown Obsessive-Compulsive Scale (Y-BOCS) scores and in the scores of both the Y-BOCS-Obsession and the Y-BOCS-Compulsion subscale at the end point. In addition, a significant improvement was observed in the total scores of the Positive and Negative Syndrome Scale and particularly in scores of anxiety, tension, depression, and preoccupation items. No adverse effects of escitalopram were reported by patients during the trial. In our prospective 12-week open-label study, escitalopram 20 mg/day was well tolerated and improved OC symptoms in schizophrenia patients. Our preliminary results are encouraging and a double-blind randomized study is required to confirm our results.

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

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    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.

  19. Supplement: Localization and broadband follow-up of the gravitational-wave transient GW150914

    CERN Document Server

    Abbott, B.P.; Abbott, T.D.; Abernathy, M.R.; Acernese, F.; Ackley, K.; Adams, C.; Adams, T.; Addesso, P.; Adhikari, R.X.; Adya, V.B.; Affeldt, C.; Agathos, M.; Agatsuma, K.; Aggarwal, N.; Aguiar, O.D.; Aiello, L.; Ain, A.; Ajith, P.; Allen, B.; Allocca, A.; Altin, P.A.; Anderson, S.B.; Anderson, W.G.; Arai, K.; Araya, M.C.; Arceneaux, C.C.; Areeda, J.S.; Arnaud, N.; Arun, K.G.; Ascenzi, S.; Ashton, G.; Ast, M.; Aston, S.M.; Astone, P.; Aufmuth, P.; Aulbert, C.; Babak, S.; Bacon, P.; Bader, M.K.M.; Baker, P.T.; Baldaccini, F.; Ballardin, G.; Ballmer, S.W.; Barayoga, J.C.; Barclay, S.E.; Barish, B.C.; Barker, D.; Barone, F.; Barr, B.; Barsotti, L.; Barsuglia, M.; Barta, D.; Barthelmy, S.; Bartlett, J.; Bartos, I.; Bassiri, R.; Basti, A.; Batch, J.C.; Baune, C.; Bavigadda, V.; Bazzan, M.; Behnke, B.; Bejger, M.; Bell, A.S.; Bell, C.J.; Berger, B.K.; Bergman, J.; Bergmann, G.; Berry, C.P.L.; Bersanetti, D.; Bertolini, A.; Betzwieser, J.; Bhagwat, S.; Bhandare, R.; Bilenko, I.A.; Billingsley, G.; Birch, J.; Birney, R.; Biscans, S.; Bisht, A.; Bitossi, M.; Biwer, C.; Bizouard, M.A.; Blackburn, J.K.; Blair, C.D.; Blair, D.G.; Blair, R.M.; Bloemen, S.; Bock, O.; Bodiya, T.P.; Boer, M.; Bogaert, G.; Bogan, C.; Bohe, A.; Bojtos, P.; Bond, C.; Bondu, F.; Bonnand, R.; Boom, B.A.; Bork, R.; Boschi, V.; Bose, S.; Bouffanais, Y.; Bozzi, A.; Bradaschia, C.; Brady, P.R.; Braginsky, V.B.; Branchesi, M.; Brau, J.E.; Briant, T.; Brillet, A.; Brinkmann, M.; Brisson, V.; Brockill, P.; Brooks, A.F.; Brown, D.A.; Brown, D.D.; Brown, N.M.; Buchanan, C.C.; Buikema, A.; Bulik, T.; Bulten, H.J.; Buonanno, A.; Buskulic, D.; Buy, C.; Byer, R.L.; Cadonati, L.; Cagnoli, G.; Cahillane, C.; Bustillo, J.C.; Callister, T.; Calloni, E.; Camp, J.B.; Cannon, K.C.; Cao, J.; Capano, C.D.; Capocasa, E.; Carbognani, F.; Caride, S.; Diaz, J.C.; Casentini, C.; Caudill, S.; Cavaglia, M.; Cavalier, F.; Cavalieri, R.; Cella, G.; Cepeda, C.B.; Baiardi, L.C.; Cerretani, G.; Cesarini, E.; Chakraborty, R.; Chalermsongsak, T.; Chamberlin, S.J.; Chan, M.; Chao, S.; Charlton, P.; Chassande-Mottin, E.; Chen, H.Y.; Chen, Y.; Cheng, C.; Chincarini, A.; Chiummo, A.; Cho, H.S.; Cho, M.; Chow, J.H.; Christensen, N.; Chu, Q.; Chua, S.; Chung, S.; Ciani, G.; Clara, F.; Clark, J.A.; Cleva, F.; Coccia, E.; Cohadon, P.F.; Colla, A.; Collette, C.G.; Cominsky, L.; Constancio, M., Jr.; Conte, A.; Conti, L.; Cook, D.; Corbitt, T.R.; Cornish, N.; Corsi, A.; Cortese, S.; Costa, C.A.; Coughlin, M.W.; Coughlin, S.B.; Coulon, J.P.; Countryman, S.T.; Couvares, P.; Cowan, E.E.; Coward, D.M.; Cowart, M.J.; Coyne, D.C.; Coyne, R.; Craig, K.; Creighton, J.D.E.; Cripe, J.; Crowder, S.G.; Cumming, A.; Cunningham, L.; Cuoco, E.; Dal Canton, T.; Danilishin, S.L.; D'Antonio, S.; Danzmann, K.; Darman, N.S.; Dattilo, V.; Dave, I.; Daveloza, H.P.; Davier, M.; Davies, G.S.; Daw, E.J.; Day, R.; DeBra, D.; Debreczeni, G.; Degallaix, J.; De Laurentis, M.; Deleglise, S.; Del Pozzo, W.; Denker, T.; Dent, T.; Dereli, H.; Dergachev, V.; DeRosa, R.T.; De Rosa, R.; DeSalvo, R.; Dhurandhar, S.; Diaz, M.C.; Di Fiore, L.; Di Giovanni, M.; Di Lieto, A.; Di Pace, S.; Di Palma, I.; Di Virgilio, A.; Dojcinoski, G.; Dolique, V.; Donovan, F.; Dooley, K.L.; Doravari, S.; Douglas, R.; Downes, T.P.; Drago, M.; Drever, R.W.P.; Driggers, J.C.; Du, Z.; Ducrot, M.; Dwyer, S.E.; Edo, T.B.; Edwards, M.C.; Effler, A.; Eggenstein, H.B.; Ehrens, P.; Eichholz, J.; Eikenberry, S.S.; Engels, W.; Essick, R.C.; Etzel, T.; Evans, M.; Evans, T.M.; Everett, R.; Factourovich, M.; Fafone, V.; Fair, H.; Fairhurst, S.; Fan, X.; Fang, Q.; Farinon, S.; Farr, B.; Farr, W.M.; Favata, M.; Fays, M.; Fehrmann, H.; Fejer, M.M.; Ferrante, I.; Ferreira, E.C.; Ferrini, F.; Fidecaro, F.; Fiori, I.; Fiorucci, D.; Fisher, R.P.; Flaminio, R.; Fletcher, M.; Fournier, J.D.; Franco, S.; Frasca, S.; Frasconi, F.; Frei, Z.; Freise, A.; Frey, R.; Frey, V.; Fricke, T.T.; Fritschel, P.; Frolov, V.V.; Fulda, P.; Fyffe, M.; Gabbard, H.A.G.; Gair, J.R.; Gammaitoni, L.; Gaonkar, S.G.; Garufi, F.; Gatto, A.; Gaur, G.; Gehrels, N.; Gemme, G.; Gendre, B.; Genin, E.; Gennai, A.; George, J.; Gergely, L.; Germain, V.; Ghosh, A.; Ghosh, S.; Giaime, J.A.; Giardina, K.D.; Giazotto, A.; Gill, K.; Glaefke, A.; Goetz, E.; Goetz, R.; Gondan, L.; Gonzalez, G.; Castro, J.M.G.; Gopakumar, A.; Gordon, N.A.; Gorodetsky, M.L.; Gossan, S.E.; Gosselin, M.; Gouaty, R.; Graef, C.; Graff, P.B.; Granata, M.; Grant, A.; Gras, S.; Gray, C.; Greco, G.; Green, A.C.; Groot, P.; Grote, H.; Grunewald, S.; Guidi, G.M.; Guo, X.; Gupta, A.; Gupta, M.K.; Gushwa, K.E.; Gustafson, E.K.; Gustafson, R.; Hacker, J.J.; Hall, B.R.; Hall, E.D.; Hammond, G.; Haney, M.; Hanke, M.M.; Hanks, J.; Hanna, C.; Hannam, M.D.; Hanson, J.; Hardwick, T.; Harms, J.; Harry, G.M.; Harry, I.W.; Hart, M.J.; Hartman, M.T.; Haster, C.J.; Haughian, K.; Heidmann, A.; Heintze, M.C.; Heitmann, H.; Hello, P.; Hemming, G.; Hendry, M.; Heng, I.S.; Hennig, J.; Heptonstall, A.W.; Heurs, M.; Hild, S.; Hoak, D.; Hodge, K.A.; Hofman, D.; Hollitt, S.E.; Holt, K.; Holz, D.E.; Hopkins, P.; Hosken, D.J.; Hough, J.; Houston, E.A.; Howell, E.J.; Hu, Y.M.; Huang, S.; Huerta, E.A.; Huet, D.; Hughey, B.; Husa, S.; Huttner, S.H.; Huynh-Dinh, T.; Idrisy, A.; Indik, N.; Ingram, D.R.; Inta, R.; Isa, H.N.; Isac, J.M.; Isi, M.; Islas, G.; Isogai, T.; Iyer, B.R.; Izumi, K.; Jacqmin, T.; Jang, H.; Jani, K.; Jaranowski, P.; Jawahar, S.; Jimenez-Forteza, F.; Johnson, W.W.; Jones, D.I.; Jones, R.; Jonker, R.J.G.; Ju, L.; H. K; Kalaghatgi, C.V.; Kalogera, V.; Kandhasamy, S.; Kang, G.; Kanner, J.B.; Karki, S.; Kasprzack, M.; Katsavounidis, E.; Katzman, W.; Kaufer, S.; Kaur, T.; Kawabe, K.; Kawazoe, F.; Kefelian, F.; Kehl, M.S.; Keitel, D.; Kelley, D.B.; Kells, W.; Kennedy, R.; Key, J.S.; Khalaidovski, A.; Khalili, F.Y.; Khan, I.; Khan, S.; Khan, Z.; Khazanov, E.A.; Kijbunchoo, N.; Kim, C.; Kim, J.; Kim, K.; Kim, N.; Kim, N.; Kim, Y.M.; King, E.J.; King, P.J.; Kinzel, D.L.; Kissel, J.S.; Kleybolte, L.; Klimenko, S.; Koehlenbeck, S.M.; Kokeyama, K.; Koley, S.; Kondrashov, V.; Kontos, A.; Korobko, M.; Korth, W.Z.; Kowalska, I.; Kozak, D.B.; Kringel, V.; Krolak, A.; Krueger, C.; Kuehn, G.; Kumar, P.; Kuo, L.; Kutynia, A.; Lackey, B.D.; Landry, M.; Lange, J.; Lantz, B.; Lasky, P.D.; Lazzarini, A.; Lazzaro, C.; Leaci, P.; Leavey, S.; Lebigot, E.O.; Lee, C.H.; Lee, H.K.; Lee, H.M.; Lee, K.; Lenon, A.; Leonardi, M.; Leong, J.R.; Leroy, N.; Letendre, N.; Levin, Y.; Levine, B.M.; Li, T.G.F.; Libson, A.; Littenberg, T.B.; Lockerbie, N.A.; Logue, J.; Lombardi, A.L.; Lord, J.E.; Lorenzini, M.; Loriette, V.; Lormand, M.; Losurdo, G.; Lough, J.D.; Luck, H.; Lundgren, A.P.; Luo, J.; Lynch, R.; Ma, Y.; MacDonald, T.; Machenschalk, B.; MacInnis, M.; Macleod, D.M.; Magana-Sandoval, F.; Magee, R.M.; Mageswaran, M.; Majorana, E.; Maksimovic, I.; Malvezzi, V.; Man, N.; Mandel, I.; Mandic, V.; Mangano, V.; Mansell, G.L.; Manske, M.; Mantovani, M.; Marchesoni, F.; Marion, F.; Marka, S.; Marka, Z.; Markosyan, A.S.; Maros, E.; Martelli, F.; Martellini, L.; Martin, I.W.; Martin, R.M.; Martynov, D.V.; Marx, J.N.; Mason, K.; Masserot, A.; Massinger, T.J.; Masso-Reid, M.; Matichard, F.; Matone, L.; Mavalvala, N.; Mazumder, N.; Mazzolo, G.; McCarthy, R.; McClelland, D.E.; McCormick, S.; McGuire, S.C.; McIntyre, G.; McIver, J.; McManus, D.J.; McWilliams, S.T.; Meacher, D.; Meadors, G.D.; Meidam, J.; Melatos, A.; Mendell, G.; Mendoza-Gandara, D.; Mercer, R.A.; Merilh, E.; Merzougui, M.; Meshkov, S.; Messenger, C.; Messick, C.; Meyers, P.M.; Mezzani, F.; Miao, H.; Michel, C.; Middleton, H.; Mikhailov, E.E.; Milano, L.; Miller, J.; Millhouse, M.; Minenkov, Y.; Ming, J.; Mirshekari, S.; Mishra, C.; Mitra, S.; Mitrofanov, V.P.; Mitselmakher, G.; Mittleman, R.; Moggi, A.; Mohan, M.; Mohapatra, S.R.P.; Montani, M.; Moore, B.C.; Moore, C.J.; Moraru, D.; Moreno, G.; Morriss, S.R.; Mossavi, K.; Mours, B.; Mow-Lowry, C.M.; Mueller, C.L.; Mueller, G.; Muir, A.W.; Mukherjee, A.; Mukherjee, D.; Mukherjee, S.; Mukund, N.; Mullavey, A.; Munch, J.; Murphy, D.J.; Murray, P.G.; Mytidis, A.; Nardecchia, I.; Naticchioni, L.; Nayak, R.K.; Necula, V.; Nedkova, K.; Nelemans, G.; Neri, M.; Neunzert, A.; Newton, G.; Nguyen, T.T.; Nielsen, A.B.; Nissanke, S.; Nitz, A.; Nocera, F.; Nolting, D.; Normandin, M.E.N.; Nuttall, L.K.; Oberling, J.; Ochsner, E.; O'Dell, J.; Oelker, E.; Ogin, G.H.; Oh, J.J.; Oh, S.H.; Ohme, F.; Oliver, M.; Oppermann, P.; Oram, R.J.; O'Reilly, B.; O'Shaughnessy, R.; Ottaway, D.J.; Ottens, R.S.; Overmier, H.; Owen, B.J.; Pai, A.; Pai, S.A.; Palamos, J.R.; Palashov, O.; Palliyaguru, N.; Palomba, C.; Pal-Singh, A.; Pan, H.; Pankow, C.; Pannarale, F.; Pant, B.C.; Paoletti, F.; Paoli, A.; Papa, M.A.; Paris, H.R.; Parker, W.; Pascucci, D.; Pasqualetti, A.; Passaquieti, R.; Passuello, D.; Patricelli, B.; Patrick, Z.; Pearlstone, B.L.; Pedraza, M.; Pedurand, R.; Pekowsky, L.; Pele, A.; Penn, S.; Perreca, A.; Phelps, M.; Piccinni, O.; Pichot, M.; Piergiovanni, F.; Pierro, V.; Pillant, G.; Pinard, L.; Pinto, I.M.; Pitkin, M.; Poggiani, R.; Popolizio, P.; Post, A.; Powell, J.; Prasad, J.; Predoi, V.; Premachandra, S.S.; Prestegard, T.; Price, L.R.; Prijatelj, M.; Principe, M.; Privitera, S.; Prodi, G.A.; Prokhorov, L.; Puncken, O.; Punturo, M.; Puppo, P.; Purrer, M.; Qi, H.; Qin, J.; Quetschke, V.; Quintero, E.A.; Quitzow-James, R.; Raab, F.J.; Rabeling, D.S.; Radkins, H.; Raffai, P.; Raja, S.; Rakhmanov, M.; Rapagnani, P.; Raymond, V.; Razzano, M.; Re, V.; Read, J.; Reed, C.M.; Regimbau, T.; Rei, L.; Reid, S.; Reitze, D.H.; Rew, H.; Reyes, S.D.; Ricci, F.; Riles, K.; Robertson, N.A.; Robie, R.; Robinet, F.; Rocchi, A.; Rolland, L.; Rollins, J.G.; Roma, V.J.; Romano, R.; Romanov, G.; Romie, J.H.; Rosinska, D.; Rowan, S.; Rudiger, A.; Ruggi, P.; Ryan, K.; Sachdev, S.; Sadecki, T.; Sadeghian, L.; Salconi, L.; Saleem, M.; Salemi, F.; Samajdar, A.; Sammut, L.; Sanchez, E.J.; Sandberg, V.; Sandeen, B.; Sanders, J.R.; Sassolas, B.; Sathyaprakash, B.S.; Saulson, P.R.; Sauter, O.; Savage, R.L.; Sawadsky, A.; Schale, P.; R. Schilling$^; Schmidt, J.; Schmidt, P.; Schnabel, R.; Schofield, R.M.S.; Schonbeck, A.; Schreiber, E.; Schuette, D.; Schutz, B.F.; Scott, J.; Scott, S.M.; Sellers, D.; Sentenac, D.; Sequino, V.; Sergeev, A.; Serna, G.; Setyawati, Y.; Sevigny, A.; Shaddock, D.A.; Shah, S.; Shahriar, M.S.; Shaltev, M.; Shao, Z.; Shapiro, B.; Shawhan, P.; Sheperd, A.; Shoemaker, D.H.; Shoemaker, D.M.; Siellez, K.; Siemens, X.; Sigg, D.; Silva, A.D.; Simakov, D.; Singer, A.; Singh, A.; Singh, R.; Singhal, A.; Sintes, A.M.; Slagmolen, B.J.J.; Smith, J.R.; Smith, N.D.; Smith, R.J.E.; Son, E.J.; Sorazu, B.; Sorrentino, F.; Souradeep, T.; Srivastava, A.K.; Staley, A.; Steinke, M.; Steinlechner, J.; Steinlechner, S.; Steinmeyer, D.; Stephens, B.C.; Stone, R.; Strain, K.A.; Straniero, N.; Stratta, G.; Strauss, N.A.; Strigin, S.; Sturani, R.; Stuver, A.L.; Summerscales, T.Z.; Sun, L.; Sutton, P.J.; Swinkels, B.L.; Szczepanczyk, M.J.; Tacca, M.; Talukder, D.; Tanner, D.B.; Tapai, M.; Tarabrin, S.P.; Taracchini, A.; Taylor, R.; Theeg, T.; Thirugnanasambandam, M.P.; Thomas, E.G.; Thomas, M.; Thomas, P.; Thorne, K.A.; Thorne, K.S.; Thrane, E.; Tiwari, S.; Tiwari, V.; Tokmakov, K.V.; Tomlinson, C.; Tonelli, M.; C.V. Torres$^; Torrie, C.I.; Toyra, D.; Travasso, F.; Traylor, G.; Trifiro, D.; Tringali, M.C.; Trozzo, L.; Tse, M.; Turconi, M.; Tuyenbayev, D.; Ugolini, D.; Unnikrishnan, C.S.; Urban, A.L.; Usman, S.A.; Vahlbruch, H.; Vajente, G.; Valdes, G.; van Bakel, N.; van Beuzekom, M.; van den Brand, J.F.J.; Van Den Broeck, C.; Vander-Hyde, D.C.; van der Schaaf, L.; van Heijningen, J.V.; van Veggel, A.A.; Vardaro, M.; Vass, S.; Vasuth, M.; Vaulin, R.; Vecchio, A.; Vedovato, G.; Veitch, J.; Veitch, P.J.; Venkateswara, K.; Verkindt, D.; Vetrano, F.; Vicere, A.; Vinciguerra, S.; Vine, D.J.; Vinet, J.Y.; Vitale, S.; Vo, T.; Vocca, H.; Vorvick, C.; Voss, D.; Vousden, W.D.; Vyatchanin, S.P.; Wade, A.R.; Wade, L.E.; Wade, M.; Walker, M.; Wallace, L.; Walsh, S.; Wang, G.; Wang, H.; Wang, M.; Wang, X.; Wang, Y.; Ward, R.L.; Warner, J.; Was, M.; Weaver, B.; Wei, L.W.; Weinert, M.; Weinstein, A.J.; Weiss, R.; Welborn, T.; Wen, L.; Wessels, P.; Westphal, T.; Wette, K.; Whelan, J.T.; White, D.J.; Whiting, B.F.; Williams, R.D.; Williamson, A.R.; Willis, J.L.; Willke, B.; Wimmer, M.H.; Winkler, W.; Wipf, C.C.; Wittel, H.; Woan, G.; Worden, J.; Wright, J.L.; Wu, G.; Yablon, J.; Yam, W.; Yamamoto, H.; Yancey, C.C.; Yap, M.J.; Yu, H.; Yvert, M.; Zadrozny, A.; Zangrando, L.; Zanolin, M.; Zendri, J.P.; Zevin, M.; Zhang, F.; Zhang, L.; Zhang, M.; Zhang, Y.; Zhao, C.; Zhou, M.; Zhou, Z.; Zhu, X.J.; Zucker, M.E.; Zuraw, S.E.; Zweizig, J.; Allison, J.; Bannister, K.; Bell, M.E.; Chatterjee, S.; Chippendale, A.P.; Edwards, P.G.; Harvey-Smith, L.; Heywood, Ian; Hotan, A.; Indermuehle, B.; Marvil, J.; McConnell, D.; Murphy, T.; Popping, A.; Reynolds, J.; Sault, R.J.; Voronkov, M.A.; Whiting, M.T.; Castro-Tirado, A.J.; Cunniffe, R.; Jelinek, M.; Tello, J.C.; Oates, S.R.; Zhang, B.B.; Hu, Y.D.; Kubanek, P.; Guziy, S.; Castellon, A.; Garcia-Cerezo, A.; Munoz, V.F.; Perez, C.; Castillo-Carrion, S.; Castro, J.M.; Hudec, R.; Caballero-Garcia, M.D.; Pata, P.; Vitek, S.; Adame, J.A.; Konig, S.; Rendon, F.; de J. Mateo, T.; Fernandez-Munoz, R.; Yock, P.C.; Rattenbury, N.; Allen, W.H.; Querel, R.; Jeong, S.; Park, I.H.; Bai, J.; Cui, Ch.; Fan, Y.; Wang, Ch.; Hiriart, D.; Lee, W.H.; Claret, A.; Sanchez-Ramirez, R.; Pandey, S.B.; Mediavilla, T.; Sabau-Graziati, L.; Abbott, T.M.C.; Abdalla, F.B.; Allam, S.; Annis, J.; Armstrong, R.; Benoit-Levy, A.; Berger, E.; Bernstein, R.A.; Bertin, E.; Brout, D.; Buckley-Geer, E.; Burke, D.L.; Capozzi, D.; Carretero, J.; Castander, F.J.; Chornock, R.; Cowperthwaite, P.S.; Crocce, M.; Cunha, C.E.; D'Andrea, C.B.; da Costa, L.N.; Desai, S.; Diehl, H.T.; Dietrich, J.P.; Doctor, Z.; Drlica-Wagner, A.; Drout, M.R.; Eifler, T.F.; Estrada, J.; Evrard, A.E.; Fernandez, E.; Finley, D.A.; Flaugher, B.; Foley, R.J.; Fong, W.F.; Fosalba, P.; Fox, D.B.; Frieman, J.; Fryer, C.L.; Gaztanaga, E.; Gerdes, D.W.; Goldstein, D.A.; Gruen, D.; Gruendl, R.A.; Gutierrez, G.; Herner, K.; Honscheid, K.; James, D.J.; Johnson, M.D.; Johnson, M.W.G.; Karliner, I.; Kasen, D.; Kent, S.; Kessler, R.; Kim, A.G.; Kind, M.C.; Kuehn, K.; Kuropatkin, N.; Lahav, O.; Li, T.S.; Lima, M.; Lin, H.; Maia, M.A.G.; Margutti, R.; Marriner, J.; Martini, P.; Matheson, T.; Melchior, P.; Metzger, B.D.; Miller, C.J.; Miquel, R.; Neilsen, E.; Nichol, R.C.; Nord, B.; Nugent, P.; Ogando, R.; Petravick, D.; Plazas, A.A.; Quataert, E.; Roe, N.; Romer, A.K.; Roodman, A.; Rosell, A.C.; Rykoff, E.S.; Sako, M.; Sanchez, E.; Scarpine, V.; Schindler, R.; Schubnell, M.; Scolnic, D.; Sevilla-Noarbe, I.; Sheldon, E.; Smith, N.; Smith, R.C.; Soares-Santos, M.; Sobreira, F.; Stebbins, A.; Suchyta, E.; Swanson, M.E.C.; Tarle, G.; Thaler, J.; Thomas, D.; Thomas, R.C.; Tucker, D.L.; Vikram, V.; Walker, A.R.; Wechsler, R.H.; Wester, W.; Yanny, B.; Zhang, Y.; Zuntz, J.; Connaughton, V.; Burns, E.; Goldstein, A.; Briggs, M.S.; Zhang, B.B.; Hui, C.M.; Jenke, P.; Wilson-Hodge, C.A.; Bhat, P.N.; Bissaldi, E.; Cleveland, W.; Fitzpatrick, G.; Giles, M.M.; Gibby, M.H.; Greiner, J.; von Kienlin, A.; Kippen, R.M.; McBreen, S.; Mailyan, B.; Meegan, C.A.; Paciesas, W.S.; Preece, R.D.; Roberts, O.; Sparke, L.; Stanbro, M.; Toelge, K.; Veres, P.; Yu, H.F.; Blackburn, L.; Ackermann, M.; Ajello, M.; Albert, A.; Anderson, B.; Atwood, W.B.; Axelsson, M.; Baldini, L.; Barbiellini, G.; Bastieri, D.; Bellazzini, R.; Bissaldi, E.; Blandford, R.D.; Bloom, E.D.; Bonino, R.; Bottacini, E.; Brandt, T.J.; Bruel, P.; Buson, S.; Caliandro, G.A.; Cameron, R.A.; Caragiulo, M.; Caraveo, P.A.; Cavazzuti, E.; Charles, E.; Chekhtman, A.; Chiang, J.; Chiaro, G.; Ciprini, S.; Cohen-Tanugi, J.; Cominsky, L.R.; Costanza, F.; Cuoco, A.; D'Ammando, F.; de Palma, F.; Desiante, R.; Digel, S.W.; Di Lalla, N.; Di Mauro, M.; Di Venere, L.; Dominguez, A.; Drell, P.S.; Dubois, R.; Favuzzi, C.; Ferrara, E.C.; Franckowiak, A.; Fukazawa, Y.; Funk, S.; Fusco, P.; Gargano, F.; Gasparrini, D.; Giglietto, N.; Giommi, P.; Giordano, F.; Giroletti, M.; Glanzman, T.; Godfrey, G.; Gomez-Vargas, G.A.; Green, D.; Grenier, I.A.; Grove, J.E.; Guiriec, S.; Hadasch, D.; Harding, A.K.; Hays, E.; Hewitt, J.W.; Hill, A.B.; Horan, D.; Jogler, T.; Johannesson, G.; Johnson, A.S.; Kensei, S.; Kocevski, D.; Kuss, M.; La Mura, G.; Larsson, S.; Latronico, L.; Li, J.; Li, L.; Longo, F.; Loparco, F.; Lovellette, M.N.; Lubrano, P.; Magill, J.; Maldera, S.; Manfreda, A.; Marelli, M.; Mayer, M.; Mazziotta, M.N.; McEnery, J.E.; Meyer, M.; Michelson, P.F.; Mirabal, N.; Mizuno, T.; Moiseev, A.A.; Monzani, M.E.; Moretti, E.; Morselli, A.; Moskalenko, I.V.; Negro, M.; Nuss, E.; Ohsugi, T.; Omodei, N.; Orienti, M.; Orlando, E.; Ormes, J.F.; Paneque, D.; Perkins, J.S.; Pesce-Rollins, M.; Piron, F.; Pivato, G.; Porter, T.A.; Racusin, J.L.; Raino, S.; Rando, R.; Razzaque, S.; Reimer, A.; Reimer, O.; Salvetti, D.; Saz Parkinson, P.M.; Sgro, C.; Simone, D.; Siskind, E.J.; Spada, F.; Spandre, G.; Spinelli, P.; Suson, D.J.; Tajima, H.; Thayer, J.B.; Thompson, D.J.; Tibaldo, L.; Torres, D.F.; Troja, E.; Uchiyama, Y.; Venters, T.M.; Vianello, G.; Wood, K.S.; Wood, M.; Zhu, S.; Zimmer, S.; Brocato, E.; Cappellaro, E.; Covino, S.; Grado, A.; Nicastro, L.; Palazzi, E.; Pian, E.; Amati, L.; Antonelli, L.A.; Capaccioli, M.; D'Avanzo, P.; D'Elia, V.; Getman, F.; Giuffrida, G.; Iannicola, G.; Limatola, L.; Lisi, M.; Marinoni, S.; Marrese, P.; Melandri, A.; Piranomonte, S.; Possenti, A.; Pulone, L.; Rossi, A.; Stamerra, A.; Stella, L.; Testa, V.; Tomasella, L.; Yang, S.; Bazzano, A.; Bozzo, E.; Brandt, S.; Courvoisier, T.J.L.; Ferrigno, C.; Hanlon, L.; Kuulkers, E.; Laurent, P.; Mereghetti, S.; Roques, J.P.; Savchenko, V.; Ubertini, P.; Kasliwal, M.M.; Singer, L.P.; Cao, Y.; Duggan, G.; Kulkarni, S.R.; Bhalerao, V.; Miller, A.A.; Barlow, T.; Bellm, E.; Manulis, I.; Rana, J.; Laher, R.; Masci, F.; Surace, J.; Rebbapragada, U.; Cook, D.; Van Sistine, A.; Sesar, B.; Perley, D.; Ferreti, R.; Prince, T.; Kendrick, R.; Horesh, A.; Hurley, K.; Golenetskii, S.V.; Aptekar, R.L.; Frederiks, D.D.; Svinkin, D.S.; Rau, A.; Zhang, X.; Smith, D.M.; Cline, T.; Krimm, H.; Abe, F.; Doi, M.; Fujisawa, K.; Kawabata, K.S.; Morokuma, T.; Motohara, K.; Tanaka, M.; Ohta, K.; Yanagisawa, K.; Yoshida, M.; Baltay, C.; Rabinowitz, D.; Ellman, N.; Rostami, S.; Bersier, D.F.; Bode, M.F.; Collins, C.A.; Copperwheat, C.M.; Darnley, M.J.; Galloway, D.K.; Gomboc, A.; Kobayashi, S.; Mazzali, P.; Mundell, C.G.; Piascik, A.S.; Pollacco, Don; Steele, I.A.; Ulaczyk, K.; Broderick, J.W.; Fender, R.P.; Jonker, P.G.; Rowlinson, A.; Stappers, B.W.; Wijers, R.A.M.J.; Lipunov, V.; Gorbovskoy, E.; Tyurina, N.; Kornilov, V.; Balanutsa, P.; Kuznetsov, A.; Buckley, D.; Rebolo, R.; Serra-Ricart, M.; Israelian, G.; Budnev, N.M.; Gress, O.; Ivanov, K.; Poleshuk, V.; Tlatov, A.; Yurkov, V.; Kawai, N.; Serino, M.; Negoro, H.; Nakahira, S.; Mihara, T.; Tomida, H.; Ueno, S.; Tsunemi, H.; Matsuoka, M.; Croft, S.; Feng, L.; Franzen, T.M.O.; Gaensler, B.M.; Johnston-Hollitt, M.; Kaplan, D.L.; Morales, M.F.; Tingay, S.J.; Wayth, R.B.; Williams, A.; Smartt, S.J.; Chambers, K.C.; Smith, K.W.; Huber, M.E.; Young, D.R.; Wright, D.E.; Schultz, A.; Denneau, L.; Flewelling, H.; Magnier, E.A.; Primak, N.; Rest, A.; Sherstyuk, A.; Stalder, B.; Stubbs, C.W.; Tonry, J.; Waters, C.; Willman, M.; Olivares E., F.; Campbell, H.; Kotak, R.; Sollerman, J.; Smith, M.; Dennefeld, M.; Anderson, J.P.; Botticella, M.T.; Chen, T.W.; Valle, M.D.; Elias-Rosa, N.; Fraser, M.; Inserra, C.; Kankare, E.; Kupfer, T.; Harmanen, J.; Galbany, L.; Le Guillou, L.; Lyman, J.D.; Maguire, K.; Mitra, A.; Nicholl, M.; Razza, A.; Terreran, G.; Valenti, S.; Gal-Yam, A.; Cwiek, A.; Cwiok, M.; Mankiewicz, L.; Opiela, R.; Zaremba, M.; Zarnecki, A.F.; Onken, C.A.; Scalzo, R.A.; Schmidt, B.P.; Wolf, C.; Yuan, F.; Evans, P.A.; Kennea, J.A.; Burrows, D.N.; Campana, S.; Cenko, S.B.; Giommi, P.; Marshall, F.E.; Nousek, J.; O'Brien, P.; Osborne, J.P.; Palmer, D.; Perri, M.; Racusin, J.; Siegel, M.; Tagliaferri, G.; Klotz, A.; Turpin, D.; Laugier, R.; Beroiz, M.; Penuela, T.; Macri, L.M.; Oelkers, R.J.; Lambas, D.G.; Vrech, R.; Cabral, J.; Colazo, C.; Dominguez, M.; Sanchez, B.; Gurovich, S.; Lares, M.; Marshall, J.L.; DePoy, D.L.; Padilla, N.; Pereyra, N.A.; Benacquista, M.; Tanvir, N.R.; Wiersema, K.; Levan, A.J.; Steeghs, D.; Hjorth, J.; Fynbo, J.P.U.; Malesani, D.; Milvang-Jensen, B.; Watson, D.; Irwin, M.; Fernandez, C.G.; McMahon, R.G.; Banerji, M.; Gonzalez-Solares, E.; Schulze, S.; de U. Postigo, A.; Thoene, C.C.; Cano, Z.; Rosswog, S.

    2016-01-01

    This Supplement provides supporting material for arXiv:1602.08492 . We briefly summarize past electromagnetic follow-up efforts as well as the organization and policy of the current electromagnetic follow-up program. We compare the four probability sky maps produced for the gravitational-wave transient GW150914, and provide additional details of the electromagnetic follow-up observations that were performed in the different bands.

  20. A decade of GRB follow-up by BOOTES in Spain (2003-2013)

    CERN Document Server

    Jelínek, Martin; Cunniffe, Ronan; Gorosabel, Javier; Vítek, Stanislav; Kubánek, Petr; Postigo, Antonio de Ugarte; Guziy, Sergey; Tello, Juan C; Páta, Petr; Sánchez-Ramírez, Rubén; Oates, Samantha; Jeong, Soomin; Štrobl, Jan; Castillo-Carrión, Sebastián; Sanguino, Tomás Mateo; Rabaza, Ovidio; Pérez-Ramírez, Dolores; Fernández-Muñoz, Rafael; Carretero, Benito A de la Morena; Hudec, René; Reglero, Víctor; Sabau-Graziati, Lola

    2016-01-01

    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 the previous article, and are here reviewed, updated, and include additional detection data points 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.

  1. Lost to follow-up: reasons and outcomes following tibial plateau fractures.

    Science.gov (United States)

    Hoffmann, Martin F; Sietsema, Debra L; Jones, Clifford B

    2016-12-01

    Different reasons for lost to follow-up are assumed. Besides "objective" reasons, "subjective" reasons and satisfaction contribute to treatment adherence. Retrospective studies usually lack the possibility of acquisition of additional outcome information. Purpose of this study was to determine outcome and factors for patients not returning for follow-up. Between 2002 and 2009, 380 patients underwent internal fixation for tibial plateau fractures. Short Musculoskeletal Function Assessment (SMFA) was collected at 6, 12, and 24 months as long as patients returned for follow-up. Pain and range of motion were measured. Records were studied for reasons of termination of follow-up. Statistical analysis was performed comparing lost to follow-up versus continued office visits regarding demographics, contributing factors, and SMFA. Two hundred fifty-nine patients were followed until treatment was completed (PRN), while 120 patients (32 %) terminated further follow-up. Patients in the 12- and 24-month follow-up groups were older (p = 0.02; p leaving treatment untimely and those being released from office visits. Follow-up remains important to obtain as much up-to-date information as possible. The current study does not support the assumption that patients lost to follow-up have a different SMFA outcome than patients returning until PRN. III.

  2. 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

    -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...... follow-up, or because of organizational aspects of the screening program, where communication regarding test results can fail either in content or with delay.This study will evaluate two interventions designed to increase follow-up: 1) A letter with the test result and potential recommendation for follow...

  3. Long-term safety, tolerability and efficacy of fesoterodine in subjects with overactive bladder symptoms stratified by age: pooled analysis of two open-label extension studies.

    Science.gov (United States)

    Sand, Peter K; Heesakkers, John; Kraus, Stephen R; Carlsson, Martin; Guan, Zhonghong; Berriman, Sandra

    2012-02-01

    Previous work has demonstrated the efficacy and safety of fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term fesoterodine treatment in different age groups has not been assessed. The aim was to determine the impact of age on the safety, tolerability and efficacy of long-term treatment with fesoterodine 8 mg in subjects with OAB syndrome. This was a pooled analysis of two identically designed open-label extensions of 12-week, randomized, double-blind, placebo-controlled studies. The setting was urology and general practice offices. Subjects who participated in the 12-week, double-blind studies and opted to continue long-term, open-label treatment with fesoterodine were included. Subjects were initiated on fesoterodine 8 mg/day at open-label baseline. After 1 month, subjects could elect dose reduction to 4 mg/day and subsequent re-escalation to 8 mg; each was permitted once annually. Maximal duration of open-label treatment ranged from 24 to 36 months. Discontinuations, subject-reported treatment tolerance, and efficacy (3-day diaries) were assessed at open-label baseline and months 1, 4, 8, 12 and 24. A total of 890 subjects were treated (age fesoterodine 8 mg throughout treatment; this rate was highest among subjects aged ≥75 years (age fesoterodine 8 mg at each visit after open-label baseline up to 36 months. No new or unexpected safety signals were observed in any age group. Most subjects reported 'good' or 'excellent' treatment tolerance throughout the study (age fesoterodine (administered primarily as 8 mg) was well tolerated and associated with sustained improvements in OAB symptoms, irrespective of age.

  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. 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

    2017-04-17

    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.

  6. [Impact of follow-up loss over visual deficiency in open-globe ocular trauma].

    Science.gov (United States)

    Lima-Gómez, Virgilio; García-Rubio, Yatzul Zuhaila; Blanco-Hernández, Dulce Milagros Razo

    2013-01-01

    Open-globe ocular trauma causes visual deficiency; calculating the magnitude of the latter often misses the estimation in patients without follow-up. to identify the modification of the postoperative proportion of visual deficiency in open-globe ocular trauma, which would introduce considering the proportion estimated in patients without follow-up. Non-interventional, retrospective, longitudinal, analytical study. Visual outcome in eyes with open-globe trauma, with and without follow-up, was calculated using the Ocular Trauma Score. The observed postoperative proportion of visual deficiency was identified in eyes with follow-up; in eyes without follow-up, the postoperative proportion of visual deficiency was estimated using an analysis of scenarios: best (Ocular Trauma Score), mean (that of eyes with follow-up) and worst (last observation/no visual improvement). The estimated proportion of visual deficiency was added to that observed in eyes with follow-up, and the resulting proportion was compared with that expected in the sample, using the Ocular Trauma Score (χ(2)). 104 eyes, 70 without follow-up and 34 without it. In eyes with follow-up the expected proportion of visual deficiency was 58.6%, and the observed one was 71.4% (p = 0.1); the estimated proportion of visual deficiency in eyes without follow-up was 76.5%. The resulting postoperative proportion of visual deficiency in the sample would be 73.1%, which would overcome that expected by the Ocular Trauma Score (59.6%, p = 0.04). In open-globe ocular trauma, the efficacy of surgery to reduce the proportion of visual deficiency would decrease with regard to the standard expected by the Ocular Trauma Score, if the deficiency estimated in eyes without follow-up were considered.

  7. The process and outcomes of a nurse-led colorectal cancer follow-up clinic.

    Science.gov (United States)

    McFarlane, K; Dixon, L; Wakeman, C J; Robertson, G M; Eglinton, T W; Frizelle, F A

    2012-05-01

    Evidence suggests that follow-up after colorectal cancer improves survival. Colorectal cancer is so common that patient follow-up can overwhelm a service, affecting the ability to see new referrals and reassess patients seen previously who have new symptoms. In order to cope with this demand a nurse-led follow-up service was started in 2004. We aimed to review the results of a nurse-led colorectal cancer follow-up clinic. Between 1 December 2004 and 31 January 2011, patients who underwent resection for colorectal cancer were followed up by a nurse specialist according to a protocol determined by the colorectal surgeons in the unit. All patient details were recorded prospectively in a purpose designed database. Nine hundred and fifty patients were followed up over 7 years. Some 368 patients were discharged from the follow-up programme, 474 patients remain actively involved in the programme and 108 patients died. Of the patients discharged from the follow-up scheme 269 (73%) were discharged to their general practitioner free of disease after 5 years. Of the 108 who patients died, 98 were as a result of colorectal cancer. Twenty patients (2.1%) were identified with local (peri-anastomotic) disease recurrence and 93 patients (9.8%) were found to have developed distant metastatic disease. Of these, 65 patients (6.8%) were referred for palliative care and 28 (2.9%) had surgery for focal metastatic disease of whom 18 were still alive at the time of this analysis. This paper shows that a nurse-led clinic for colorectal cancer follow-up can achieve satisfactory results with detection rates of recurrent or metastatic disease comparable to consultant follow-up. A nurse-led clinic provides the benefits of follow-up without overwhelming the consultant colorectal surgical clinic practice. © 2011 The Authors. Colorectal Disease © 2011 The Association of Coloproctology of Great Britain and Ireland.

  8. Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer

    Directory of Open Access Journals (Sweden)

    Dirksen Carmen D

    2010-04-01

    Full Text Available Abstract Background Current frequent follow-up after treatment for breast cancer does not meet its intended aims, but does depend on expensive and scarce specialized knowledge for routine history taking and physical examinations. The study described in this paper compared patient satisfaction with a reduced follow-up strategy, i.e. nurse-led telephone follow-up, to satisfaction with traditional hospital follow-up. Methods Patient satisfaction was assessed among patients (n = 299 who were participants of a randomized controlled trial investigating the cost-effectiveness of several follow-up strategies in the first year after treatment for breast cancer. Data on patient satisfaction were collected at baseline, three, six and 12 months after treatment, using the Dutch version of Ware's Patient Satisfaction Questionnaire III (PSQ III. In addition to general satisfaction, the PSQ III reports on satisfaction scores for technical competence, interpersonal aspects, and access of care. Regression analysis was used to predict satisfaction scores from whether or not nurse-led telephone follow-up was received. Results Nurse-led telephone follow-up had no statistically significant influence on general patient satisfaction (p = 0.379, satisfaction with technical competence (p = 0.249, and satisfaction with interpersonal aspects (p = 0.662. Regarding access of care, patient satisfaction scores were significantly higher for patients receiving telephone follow-up (p = 0.015. However, a mean difference at 12 months of 3.1 points was judged to be not clinically relevant. Conclusions No meaningful differences were found in satisfaction scores between nurse-led telephone and hospital follow-up in the first year after breast cancer treatment. With high satisfaction scores and the potential to substantially reduce clinic visits, nurse-led telephone follow-up may be an acceptable alternative to traditional hospital follow-up. Trial registration number ISRCTN 74071417.

  9. 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.

  10. 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.

    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 cardio

  11. Long-term follow-up after urethral injection with polyacrylamide hydrogel for female stress incontinence

    DEFF Research Database (Denmark)

    Mouritsen, Lone; Lose, Gunnar; Møller-Bek, Karl

    2014-01-01

    Urethral injection therapy for treatment of stress urinary incontinence has been in use for years, but only a few long-term follow-up studies have been published. Twenty-five women, injected with polyacrylamide hydrogel 8 years earlier, were invited for follow-up. Twenty-four could be contacted; ...

  12. How Do Mode and Timing of Follow-up Surveys Affect Evaluation Success?

    Science.gov (United States)

    Koundinya, Vikram; Klink, Jenna; Deming, Philip; Meyers, Andrew; Erb, Kevin

    2016-01-01

    This article presents the analysis of evaluation methods used in a well-designed and comprehensive evaluation effort of a significant Extension program. The evaluation data collection methods were analyzed by questionnaire mode and timing of follow-up surveys. Response rates from the short- and long-term follow-ups and different questionnaire…

  13. Follow Up Study of Non College Bound Somerset County High School Graduates June 1990, New Jersey.

    Science.gov (United States)

    Doty, Charles R.

    A follow-up study sought to determine what happened to the 1990 noncollege-bound graduates of all the high schools in Somerset County, New Jersey. Data were gathered through a mailed survey and telephone follow-up (approximately 45 percent response) of the 408 graduates of the 12 of 13 high schools providing names. Some of the findings from…

  14. Two-Year Follow-Up of Bibliotherapy and Individual Cognitive Therapy for Depressed Older Adults

    Science.gov (United States)

    Floyd, Mark; Rohen, Noelle; Shackelford, Jodie A. M.; Hubbard, Karen L.; Parnell, Marsha B.; Scogin, Forrest; Coates, Adriana

    2006-01-01

    This study examined the stability of treatment gains after receiving either cognitive bibliotherapy or individual cognitive psychotherapy for depression in older adults. A 2-year follow-up of 23 participants from Floyd, Scogin, McKendree-Smith, Floyd, and Rokke (2004) was conducted by comparing pre- and posttreatment scores with follow-up scores…

  15. PERMANENT CARDIAC PACING IN CHILDREN - MORBIDITY AND EFFICACY OF FOLLOW-UP

    NARCIS (Netherlands)

    KERSTJENSFREDERIKSE, MWS; BINKBOELKENS, MTE; DEJONGSTE, MJL; VANDERHEIDE, JNH

    1991-01-01

    The data from 50 permanently paced children [mean standard deviation follow-up 5.3 +/- 3.7 years] were reviewed, with special attention being paid to the cause of complications and the efficacy of follow-up. The 5-year survival (SD) of the patients was 78 +/- 6%; mortality was mainly due to the unde

  16. Follow-up after gamma knife radiosurgery for vestibular schwannomas: volumetric and axial control rates

    NARCIS (Netherlands)

    Timmer, F.C.A.; Hanssens, P.E.; Haren, A.E. van; Overbeeke, J.J. van; Mulder, J.J.S.; Cremers, C.W.R.J.; Graamans, K.

    2011-01-01

    OBJECTIVES/HYPOTHESIS: A prospective long-term follow-up study was conducted to evaluate the results of gamma knife radiosurgery (GKRS) for vestibular schwannoma (VS) patients. Both axial and volumetric measurements are used to determine tumor size during follow-up. STUDY DESIGN: Individual prospect

  17. The RETHINK Parenting and Anger Management Program: A Follow-Up Validation Study

    Science.gov (United States)

    Fetsch, Robert J.; Yang, Raymond K.; Pettit, Matthew J.

    2008-01-01

    This study is the first follow-up assessment of the RETHINK Parenting and Anger Management Program. Parent participants (N = 168) reduced their anger, violence, and family conflict levels from posttest to follow-up, on average, at 2.5 months on 13 of 15 dependent variables. Current findings are consistent with a small, albeit growing body of…

  18. 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

  19. Routine follow-up after laryngeal cancer treatment : the assessment of pre-symptomatic recurrence detection

    NARCIS (Netherlands)

    Ritoe, Savitri Christine

    2007-01-01

    The principal goal of the follow-up program as formulated for patients with laryngeal carcinoma is the pre-symptomatic detection of local and regional recurrences. Different studies were conducted to evaluate the effectiviness of this follow-up protocol. The first study comprised 402 patients with s

  20. 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 agen

  1. Long-term follow-up results of primary and recurrent pigmented villonodular synovitis

    NARCIS (Netherlands)

    Verspoor, F.G.; Zee, A.A.; Hannink, G.; Geest, I.C. van der; Veth, R.P.H.; Schreuder, H.W.

    2014-01-01

    OBJECTIVE: Adequate documentation of the outcome of treatment of pigmented villonodular synovitis (PVNS) is sparse. Available case series show relatively short follow-up times and often combine locations or subtypes to increase patient numbers. This article describes the long-term follow-up of a sin

  2. Neuroleptic Malignant Syndrome Requiring Neurological Intensive Care Unit Follow-up: Review with Nine Cases

    Directory of Open Access Journals (Sweden)

    Nazlı Gamze Bülbül

    2014-12-01

    Full Text Available Neuroleptic malignant syndrome (NMS is a rare but life-threatening clinical manifestation induced by neuroleptic medication. Although NMS is regarded as a psychiatric diagnosis, its treatment requires a systematic approach and thus intensive care follow-up. In this paper, we report nine cases with NMS followed up in our Neurology Intensive Care Unit over the last three years.

  3. A Research on Students' Needs for Follow-Up Curriculum of College English

    Science.gov (United States)

    Jin, Jie; Liu, Hengying; Zhang, Yan

    2015-01-01

    Increased universities and colleges offer the undergraduates with more follow-up courses with the further reform in college English education in China. An investigation on self-evaluation, difficulty, and willingness of undergraduates in learning English further was made in order to design more appropriate and adaptable follow-up courses. This…

  4. The RETHINK Parenting and Anger Management Program: A Follow-Up Validation Study

    Science.gov (United States)

    Fetsch, Robert J.; Yang, Raymond K.; Pettit, Matthew J.

    2008-01-01

    This study is the first follow-up assessment of the RETHINK Parenting and Anger Management Program. Parent participants (N = 168) reduced their anger, violence, and family conflict levels from posttest to follow-up, on average, at 2.5 months on 13 of 15 dependent variables. Current findings are consistent with a small, albeit growing body of…

  5. Individual Risk Profiling For Breast Cancer Recurrence: Towards Tailored Follow-Up Schemes

    NARCIS (Netherlands)

    Kraeima, J.; Vliegen, I.; Siesling, S.; Klaase, J.; IJzerman, M.J.

    2013-01-01

    Objectives Current international guidelines for breast cancer follow-up are not specific to individual risk of local regional recurrences. Instead, for personalised follow-up it is required to have more precise estimates of local regional recurrence probability as a function of time. The objective o

  6. Clinical and radiological long-term follow-up after embolization of pulmonary arteriovenous malformations

    DEFF Research Database (Denmark)

    Andersen, Poul Erik; Kjeldsen, Anette D

    2005-01-01

    . Outcome parameters at follow-up were PaO(2) and patients' satisfaction. During follow-up, the patients had a clinical examination, measurement of arterial blood gases, chest X-ray, and contrast echocardiography performed and were asked to fill in a questionnaire exploring experience of the treatment...

  7. Patient preference regarding assessment of clinical follow-up after percutaneous coronary intervention: the PAPAYA study

    NARCIS (Netherlands)

    Kok, M.; Birgelen, von C.; Lam, M.K.; Lowik, M.; Houwelingen, van G.; Stoel, M.; Louwerenburg, H.; Man, de F.H.; Hartmann, M.; Doggen, C.J.; Til, van J.A.; IJzerman, M.J.

    2015-01-01

    Aims: To keep patients in long-term clinical follow-up programmes after percutaneous coronary intervention (PCI), knowledge of the patient-preferred mode for follow-up assessment is crucial. We systematically assessed patient preference, and explored potential relationships with age and gender.Metho

  8. Patient preference regarding assessment of clinical follow-up after percutaneous coronary intervention: the PAPAYA study

    NARCIS (Netherlands)

    Kok, Marlies M.; Birgelen, von Clemens; Lam, Ming Kai; Löwik, Marije M.; Houwelingen, van K. Gert; Stoel, Martin G.; Louwerenburg, J. (Hans) W.; Man, de Frits H.A.F.; Hartmann, Marc; Doggen, Carine J.M.; Til, van Janine A.; IJzerman, Maarten J.

    2016-01-01

    Aims: To keep patients in long-term clinical follow-up programmes after percutaneous coronary intervention (PCI), knowledge of the patient-preferred mode for follow-up assessment is crucial. We systematically assessed patient preference, and explored potential relationships with age and gender.Metho

  9. The clinical value and the cost-effectiveness of follow-up in endometrial cancer patients.

    Science.gov (United States)

    Tjalma, W A A; van Dam, P A; Makar, A P; Cruickshank, D J

    2004-01-01

    The aim of the present article was to evaluate the cost-effectiveness of follow-up in endometrial cancer patients. A literature review was performed regarding the studies that addressed routine follow-up of endometrial cancer. For each published study, the costs of the follow-up program were calculated according to Belgium standards. A mean total of 13% relapsed. Symptomatology and clinical examination detected over 83% of the recurrences. The follow-up cost in euro after 5 and 10 years ranged between 127.68 and 2,028.78 and between 207.48 and 2,353.48, respectively. Based on the available data, there is little evidence of routine follow-up improving survival rates. Multiple protocols are used in practice without an evidence base. There is an urgent need for prospective randomized studies to evaluate the value of the current so-called 'standard medical practice of follow-up.' It is to be expected that the cost of follow-up could be reduced considerably, for instance, by tailoring to low- and high-risk groups, or by abandoning routine follow-up. Symptomatic patients, however, should be evaluated immediately. A reduction in the number of visits and examinations would mean an enormous reduction in costs. This economic benefit would be warmly welcomed in the times of increased health costs and decreased budgets.

  10. Effect on Mail Survey Return Rates of Including Questionnaires With Follow-Up Letters.

    Science.gov (United States)

    Futrell, Charles M.; Lamb, Charles W., Jr.

    1981-01-01

    Two thousand questionnaires were mailed to respondents allocated among seven treatments. Controls received an initial mailing (questionnaire and cover letter) only. The remaining six treatments varied by number of follow-up mailings and whether another questionnaire copy was included. Results suggest more than one follow-up letter with a…

  11. Follow-up after gamma knife radiosurgery for vestibular schwannomas: volumetric and axial control rates

    NARCIS (Netherlands)

    Timmer, F.C.A.; Hanssens, P.E.; Haren, A.E. van; Overbeeke, J.J. van; Mulder, J.J.S.; Cremers, C.W.R.J.; Graamans, K.

    2011-01-01

    OBJECTIVES/HYPOTHESIS: A prospective long-term follow-up study was conducted to evaluate the results of gamma knife radiosurgery (GKRS) for vestibular schwannoma (VS) patients. Both axial and volumetric measurements are used to determine tumor size during follow-up. STUDY DESIGN: Individual

  12. Long-term follow-up of surgical treatment for thumb duplication

    NARCIS (Netherlands)

    Larsen, M; Nicolai, JPA

    2005-01-01

    There are few long-term follow-up reports concerning the treatment of thumb duplication. We reviewed the treatment of 19 of 74 patients treated at our institution between 1956 and 2002. The average follow-up was 22 (range, 7 years to 35 years) years. Satisfactory function was achieved in 18 thumbs a

  13. Individual Risk Profiling For Breast Cancer Recurrence: Towards Tailored Follow-Up Schemes

    NARCIS (Netherlands)

    Kraeima, J.; Vliegen, I.; Siesling, Sabine; Klaase, J.; IJzerman, Maarten Joost

    2013-01-01

    Objectives Current international guidelines for breast cancer follow-up are not specific to individual risk of local regional recurrences. Instead, for personalised follow-up it is required to have more precise estimates of local regional recurrence probability as a function of time. The objective

  14. 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

  15. Two-Year Follow-Up of Bibliotherapy and Individual Cognitive Therapy for Depressed Older Adults

    Science.gov (United States)

    Floyd, Mark; Rohen, Noelle; Shackelford, Jodie A. M.; Hubbard, Karen L.; Parnell, Marsha B.; Scogin, Forrest; Coates, Adriana

    2006-01-01

    This study examined the stability of treatment gains after receiving either cognitive bibliotherapy or individual cognitive psychotherapy for depression in older adults. A 2-year follow-up of 23 participants from Floyd, Scogin, McKendree-Smith, Floyd, and Rokke (2004) was conducted by comparing pre- and posttreatment scores with follow-up scores…

  16. 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

  17. 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 ne

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

    NARCIS (Netherlands)

    Wensing, B.M.; Merkx, M.A.W.; Krabbe, P.F.M.; Marres, H.A.M.; Hoogen, F.J.A. van den

    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 ne

  19. 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

  20. Vagus nerve stimulation in drug-resistant epilepsy: the efficacy and adverse effects in a 5-year follow-up study in Iran.

    Science.gov (United States)

    Pakdaman, Hossein; Amini Harandi, Ali; Abbasi, Mehdi; Karimi, Mohammad; Arami, Mohammad Ali; Mosavi, Seyed Ali; Haddadian, Karim; Rezaei, Omidvar; Sadeghi, Sohrab; Sharifi, Guive; Gharagozli, Koroush; Bahrami, Parviz; Ashrafi, Farzad; Kasmae, Hosein Delavar; Ghassemi, Amirhossein; Arabahmadi, Mehran; Behnam, Behdad

    2016-11-01

    Drug-resistant epilepsy seems like a different disease compared with easy to control epilepsy, and new strategies are needed to help these patients. Vagus nerve stimulation (VNS) therapy is the most frequently used neurostimulation modality for patients with drug-resistant epilepsy who are not eligible for seizure surgery. In this study, we aimed to evaluate the efficacy and adverse effects of VNS in patients with drug-resistant epilepsy in an open-label, prospective, long-term study in Iran. We selected 48 patients with partial-onset drug-resistant epilepsy. Implantations were performed in the neurosurgery department of Loghman Hospital, Tehran, Iran. Follow-up visits were done on monthly bases for 5 years. Forty-four patients completed the study. Mean age of patients was 24.4 years. Mean years of epilepsy history was 14 years. The mean number of anti-epileptic drugs did not significantly change over five years (p = 0.15). There was no exacerbation of epilepsy; however, one patient discontinued his therapy due to unsatisfactory results. Five patient had more than 50 %, and 26 patients (59 %) had 25-49 % reduction in the frequency of monthly seizures persistently. Overall mean frequency of monthly seizures decreased by 57.8, 59.6, 65, 65.9, and 67 %, in 1st, 2nd, 3rd, 4th, and 5th years of follow-up, respectively. Most common side effects were as follows: hoarseness (25 %) and throat discomfort (10 %). We found VNS as a safe and effective therapy for drug-resistant epilepsy, with an approximate long-term decrease in mean seizure frequency of 57.8-67 %. Thus, VNS is recommended for suitable patients in developing countries.

  1. EA follow-up in the Ghanaian mining sector: Challenges and opportunities

    Energy Technology Data Exchange (ETDEWEB)

    Appiah-Opoku, Seth, E-mail: sappiah@bama.ua.edu [Geography Department, University of Alabama, 230 Farrah Hall, Tuscaloosa, AL 35487 (United States); Bryan, Hobson C. [Geography Department, University of Alabama, 330 Farrah Hall, Tuscaloosa, AL 35487 (United States)

    2013-07-15

    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.

  2. Post-surgical tympanostomy tube follow up with audiology: experience at the Freeman Hospital.

    Science.gov (United States)

    Davies-Husband, C R; Harker, C; Davison, T; Yates, P D

    2012-02-01

    Tympanostomy tube (grommet) insertion is a common procedure, with little guidance in the current literature regarding post-operative surveillance. Our institution implemented a protocol to follow up post-surgical grommet patients via audiology at six weeks. A retrospective audit of all patients less than 16 years old who had undergone grommet insertion during a three-month period. A total of 149 patients had grommets inserted. Exclusion criteria left a cohort of 123 individuals; 82 (67 per cent) were followed up by audiology. Of these, 13 (11 per cent) did not attend follow up, and were discharged; 53 (43 per cent) were discharged from audiology with normal thresholds; and 16 (13 per cent) were referred back to a consultant. Therefore, the overall reduction in patients followed up by an otolaryngologist was 54 per cent. We recommend a six-week follow up with audiology following grommet insertion, allowing for referral back to ENT services in the event of related complications.

  3. Effects of nurse-led telephone follow-up for discharged patients treated with chemotherapy

    Directory of Open Access Journals (Sweden)

    Gui Li

    2014-01-01

    Full Text Available Objective: Nurse-led telephone follow-up is effective in meeting information and psycho-social needs. We explored the potential effects of nurse-led telephone follow-up for patients treated with chemotherapy in China. Methods: A quasi-experimental study was employed in the research. 300 cases of cancer inpatients in a cancer hospital in Beijing during July-October 2012 were selected by convenience sampling. To compare the satisfaction and response regarding to chemotherapy adverse side effects, patients who discharged on Monday and Friday were provided with telephone follow-up. Patients who discharged on Tuesday, Wednesday and Thursday received routine care. Results: Via telephone follow-up, patient satisfaction relating to nursing care increased. Moreover, their response to chemotherapy adverse side effects showed a significant difference. Conclusion: Telephone follow-up by specialist nurses may be a feasible option. It was well received by patients, with no physical or psychological disadvantage.

  4. 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...

  5. Gynaecological cancer follow-up: national survey of current practice in the UK.

    Science.gov (United States)

    Leeson, Simon; Stuart, Nick; Sylvestre, Yvonne; Hall, Liz; Whitaker, Rhiannon

    2013-01-01

    To establish a baseline of national practice for follow-up after treatment for gynaecological cancer. Questionnaire survey. Gynaecological cancer centres and units. Members of the British Gynaecological Cancer Society and the National Forum of Gynaecological Oncology Nurses. A questionnaire survey. To determine schedules of follow-up, who provides it and what routine testing is used for patients who have had previous gynaecological cancer. A total of 117 responses were obtained; 115 (98%) reported hospital scheduled regular follow-up appointments. Two involved general practitioners. Follow-up was augmented or replaced by telephone follow-up in 29 responses (25%) and patient-initiated appointments in 38 responses (32%). A total of 80 (68%) cancer specialists also offered combined follow-up clinics with other specialties. Clinical examinations for hospital-based follow-up were mainly performed by doctors (67% for scheduled regular appointments and 63% for patient-initiated appointments) while telephone follow-up was provided in the majority by nurses (76%). Most respondents (76/117 (65%)) provided routine tests, of which 66/76 (87%) reported carrying out surveillance tests for ovarian cancer, 35/76 (46%) for cervical cancer, 8/76 (11%) for vulval cancer and 7/76 (9%) for endometrial cancer. Patients were usually discharged after 5 years (82/117 (70%)), whereas three (3%) were discharged after 4 years, nine (8%) after three years and one (1%) after 2 years. Practice varied but most used a standard hospital-based protocol of appointments for 5 years and routine tests were performed usually for women with ovarian cancer. A minority utilised nurse-led or telephone follow-up. General practitioners were rarely involved in routine care. A randomised study comparing various models of follow-up could be considered.

  6. Results of a phase II, open-label, non-comparative study of intralesional PV-10 followed by radiotherapy for the treatment of in-transit or metastatic melanoma.

    Science.gov (United States)

    Foote, Matthew; Read, Tavis; Thomas, Janine; Wagels, Michael; Burmeister, Bryan; Smithers, B Mark

    2017-06-01

    In-transit and recurrent dermal or subcutaneous melanoma metastases represent a significant burden of advanced disease. Intralesional Rose Bengal can elicit tumor selective ablation and a T-cell mediated abscopal effect in untreated lesions. A subset of patients in a phase II trial setting received external beam radiotherapy to their recurrent lesions with complete or partial response and no significant acute radiation reaction. An open-label, single-arm phase II study was performed to assess the efficacy and safety of PV-10 followed by hypofractionated radiotherapy. Patients had in-transit melanoma metastases suitable for IL therapy and radiotherapy. Fifteen patients were enrolled and thirteen completed both treatment components. The overall response rate was 86.6% and the clinical benefit was 93.3% on an intention to treat analysis (CR 33.3%, PR 53.3%, SD 6.7%). The median follow up duration was 19.25 months. Size of metastases (Treatment was well tolerated with no associated grade 4 or 5 adverse events. The combination of PV-10 and radiotherapy resulted in lesion-specific, normal tissue-sparing, ablation of disease with minimal local or systemic adverse effects. © 2017 Wiley Periodicals, Inc.

  7. Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study

    Science.gov (United States)

    Brodnicki, Elizabeth; Desai, Monica; McCormack, Sheena; Nutland, Will; Wayal, Sonali; White, Ellen; Wood, Gemma; Barber, Tristan; Bell, Gill; Clarke, Amanda; Dolling, David; Dunn, David; Fox, Julie; Haddow, Lewis; Lacey, Charles; Nardone, Anthony; Quinn, Killian; Rae, Caroline; Reeves, Iain; Rayment, Michael; White, David; Apea, Vanessa; Ayap, Wilbert; Dewsnap, Claire; Collaco-Moraes, Yolanda; Schembri, Gabriel; Sowunmi, Yinka; Horne, Rob

    2017-01-01

    Background PROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design. Methods Participants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants. Results Acceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported ‘being deferred’ as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design. Conclusion The quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and

  8. Short-term open-label chamomile (Matricaria chamomilla L.) therapy of moderate to severe generalized anxiety disorder.

    Science.gov (United States)

    Keefe, John R; Mao, Jun J; Soeller, Irene; Li, Qing S; Amsterdam, Jay D

    2016-12-15

    Conventional drug treatments for Generalized Anxiety Disorder (GAD) are often accompanied by substantial side effects, dependence, and/or withdrawal syndrome. A prior controlled study of oral chamomile (Matricaria chamomilla L.) extract showed significant efficacy versus placebo, and suggested that chamomile may have anxiolytic activity for individuals with GAD. We hypothesized that treatment with chamomile extract would result in a significant reduction in GAD severity ratings, and would be associated with a favorable adverse event and tolerability profile. We report on the open-label phase of a two-phase randomized controlled trial of chamomile versus placebo for relapse-prevention of recurrent GAD. Subjects with moderate to severe GAD received open-label treatment with pharmaceutical-grade chamomile extract 1500mg/day for up to 8 weeks. Primary outcomes were the frequency of clinical response and change in GAD-7 symptom scores by week 8. Secondary outcomes included the change over time on the Hamilton Rating Scale for Anxiety, the Beck Anxiety Inventory, and the Psychological General Well Being Index. Frequency of treatment-emergent adverse events and premature treatment discontinuation were also examined. Of 179 subjects, 58.1% (95% CI: 50.9% to 65.5%) met criteria for response, while 15.6% prematurely discontinued treatment. Significant improvement over time was also observed on the GAD-7 rating (β=-8.4 [95% CI=-9.1 to -7.7]). A similar proportion of subjects demonstrated statistically significant and clinically meaningful reductions in secondary outcome ratings of anxiety and well-being. Adverse events occurred in 11.7% of subjects, although no serious adverse events occurred. Chamomile extract produced a clinically meaningful reduction in GAD symptoms over 8 weeks, with a response rate comparable to those observed during conventional anxiolytic drug therapy and a favorable adverse event profile. Future comparative effectiveness trials between chamomile and

  9. An open-label pilot study of quetiapine plus mirtazapine for heavy drinkers with alcohol use disorder.

    Science.gov (United States)

    Brunette, Mary F; Akerman, Sarah C; Dawson, Ree; O'Keefe, Christopher D; Green, Alan I

    2016-06-01

    Animal research suggests that medications that produce a weak dopamine D2 receptor blockade and potentiate noradrenergic activity may decrease alcohol drinking. In an open-label pilot study of subjects with alcohol dependence, we tested whether the combination of quetiapine, a weak dopamine D2 receptor antagonist, whose primary metabolite, desalkylquetiapine, is a norepinephrine reuptake inhibitor, and mirtazapine, a potent α2 norepinephrine receptor antagonist, would decrease alcohol drinking and craving. Twenty very heavy drinkers with alcohol dependence entered a trial of 8 weeks of treatment with quetiapine followed by 8 weeks of treatment with a combination of quetiapine plus mirtazapine. Alcohol use was assessed weekly with a Timeline Follow-Back interview and craving with the Penn Alcohol Craving Scale. Among the 11 completers, subjects reported improved outcomes in the quetiapine plus mirtazapine period compared to the quetiapine alone period: fewer very heavy drinking days per week (1.3 [SD = 2.4] vs. 2.1 [SD = 2.8]; t = 2.3, df = 10, p = 0.04); fewer total number of drinks per week (39.7 [SD = 61.6] vs. 53.4 [SD = 65.0]; t = 2.8, df = 10, p = 0.02); and lower craving scores (2.5 [SD = 1.4] vs. 3.2 [SD = 1.2]; t = 2.4, df = 10, p = 0.04). All subjects reported at least one adverse event; 72.7% reported somnolence. In this open-label pilot study, treatment with quetiapine plus mirtazapine was associated with a decrease in alcohol drinking and craving. These findings are consistent with our previous work in animal models of alcohol use disorders and suggest that further study of medications or combinations of medications with this pharmacologic profile is warranted.

  10. 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

  11. Large Regional Differences in Serological Follow-Up of Q Fever Patients in The Netherlands

    Science.gov (United States)

    Morroy, Gabriëlla; Wielders, Cornelia C. H.; Kruisbergen, Mandy J. B.; van der Hoek, Wim; Marcelis, Jan H.; Wegdam-Blans, Marjolijn C. A.; Wijkmans, Clementine J.; Schneeberger, Peter M.

    2013-01-01

    Background During the Dutch Q fever epidemic more than 4,000 Q fever cases were notified. This provided logistical challenges for the organisation of serological follow-up, which is considered mandatory for early detection of chronic infection. The aim of this study was to investigate the proportion of acute Q fever patients that received serological follow-up, and to identify regional differences in follow-up rates and contributing factors, such as knowledge of medical practitioners. Methods Serological datasets of Q fever patients diagnosed between 2007 and 2009 (N = 3,198) were obtained from three Laboratories of Medical Microbiology (LMM) in the province of Noord-Brabant. One LMM offered an active follow-up service by approaching patients; the other two only tested on physician's request. The medical microbiologist in charge of each LMM was interviewed. In December 2011, 240 general practices and 112 medical specialists received questionnaires on their knowledge and practices regarding the serological follow-up of Q fever patients. Results Ninety-five percent (2,226/2,346) of the Q fever patients diagnosed at the LMM with a follow-up service received at least one serological follow-up within 15 months of diagnosis. For those diagnosed at a LMM without this service, this was 25% (218/852) (OR 54, 95% CI 43–67). Although 80% (162/203) of all medical practitioners with Q fever patients reported informing patients of the importance of serological follow-up, 33% (67/203) never requested it. Conclusions Regional differences in follow-up are substantial and range from 25% to 95%. In areas with a low follow-up rate the proportion of missed chronic Q fever is potentially higher than in areas with a high follow-up rate. Medical practitioners lack knowledge regarding the need, timing and implementation of serological follow-up, which contributes to patients receiving incorrect or no follow-up. Therefore, this information should be incorporated in national guidelines

  12. Large regional differences in serological follow-up of Q fever patients in the Netherlands.

    Directory of Open Access Journals (Sweden)

    Gabriëlla Morroy

    Full Text Available BACKGROUND: During the Dutch Q fever epidemic more than 4,000 Q fever cases were notified. This provided logistical challenges for the organisation of serological follow-up, which is considered mandatory for early detection of chronic infection. The aim of this study was to investigate the proportion of acute Q fever patients that received serological follow-up, and to identify regional differences in follow-up rates and contributing factors, such as knowledge of medical practitioners. METHODS: Serological datasets of Q fever patients diagnosed between 2007 and 2009 (N = 3,198 were obtained from three Laboratories of Medical Microbiology (LMM in the province of Noord-Brabant. One LMM offered an active follow-up service by approaching patients; the other two only tested on physician's request. The medical microbiologist in charge of each LMM was interviewed. In December 2011, 240 general practices and 112 medical specialists received questionnaires on their knowledge and practices regarding the serological follow-up of Q fever patients. RESULTS: Ninety-five percent (2,226/2,346 of the Q fever patients diagnosed at the LMM with a follow-up service received at least one serological follow-up within 15 months of diagnosis. For those diagnosed at a LMM without this service, this was 25% (218/852 (OR 54, 95% CI 43-67. Although 80% (162/203 of all medical practitioners with Q fever patients reported informing patients of the importance of serological follow-up, 33% (67/203 never requested it. CONCLUSIONS: Regional differences in follow-up are substantial and range from 25% to 95%. In areas with a low follow-up rate the proportion of missed chronic Q fever is potentially higher than in areas with a high follow-up rate. Medical practitioners lack knowledge regarding the need, timing and implementation of serological follow-up, which contributes to patients receiving incorrect or no follow-up. Therefore, this information should be incorporated in

  13. A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya

    Directory of Open Access Journals (Sweden)

    Akhwale Willis S

    2008-12-01

    Full Text Available Abstract Background Artemether/lumefantrine (AL has been adopted as the treatment of choice for uncomplicated malaria in Kenya and other countries in the region. Six-dose artemether/lumefantrine tablets are highly effective and safe for the treatment of infants and children weighing between five and 25 kg with uncomplicated Plasmodium falciparum malaria. However, oral paediatric formulations are urgently needed, as the tablets are difficult to administer to young children, who cannot swallow whole tablets or tolerate the bitter taste of the crushed tablets. Methods A randomized, controlled, open-label trial was conducted comparing day 28 PCR corrected cure-rates in 245 children aged 6–59 months, treated over three days with either six-dose of artemether/lumefantrine tablets (Coartem® or three-dose of artemether/lumefantrine suspension (Co-artesiane® for uncomplicated falciparum malaria in western Kenya. The children were followed-up with clinical, parasitological and haematological evaluations over 28 days. Results Ninety three percent (124/133 and 90% (121/134 children in the AL tablets and AL suspension arms respectively completed followed up. A per protocol analysis revealed a PCR-corrected parasitological cure rate of 96.0% at Day 28 in the AL tablets group and 93.4% in the AL suspension group, p = 0.40. Both drugs effectively cleared gametocytes and were well tolerated, with no difference in the overall incidence of adverse events. Conclusion The once daily three-dose of artemether-lumefantrine suspension (Co-artesiane® was not superior to six-dose artemether-lumefantrine tablets (Coartem® for the treatment of uncomplicated malaria in children below five years of age in western Kenya. Trial registration ClinicalTrials.gov NCT00529867

  14. Effect of open-label infusion of an apoA-I-containing particle (CER-001) on RCT and artery wall thickness in patients with FHA

    NARCIS (Netherlands)

    Kootte, Ruud S.; Smits, Loek P.; van der Valk, Fleur M.; Dasseux, Jean-Louis; Keyserling, Constance H.; Barbaras, Ronald; Paolini, John F.; Santos, Raul D.; van Dijk, Theo H.; Dallinga-van Thie, Geesje M.; Nederveen, Aart J.; Mulder, Willem J. M.; Hovingh, G. Kees; Kastelein, John J. P.; Groen, Albert K.; Stroes, Erik S.

    2015-01-01

    Reverse cholesterol transport (RCT) contributes to the anti-atherogenic effects of HDL. Patients with the orphan disease, familial hypoalphalipoproteinemia (FHA), are characterized by decreased tissue cholesterol removal and an increased atherogenic burden. We performed an open-label uncontrolled pr

  15. 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…

  16. Sustained improvement in patient-reported outcomes during long-term fesoterodine treatment for overactive bladder symptoms: pooled analysis of two open-label extension studies.

    Science.gov (United States)

    Kelleher, Con J; Dmochowski, Roger R; Berriman, Sandra; Kopp, Zoe S; Carlsson, Martin

    2012-08-01

    • To evaluate the effects of long-term fesoterodine treatment on health-related quality of life (HRQL) and treatment satisfaction in subjects with overactive bladder (OAB) symptoms. • To determine the impact of gender and age on these effects. • This is a post hoc analysis of data pooled from identically designed open-label extensions of two randomized, double-blind, 12-week fesoterodine studies. • Initial treatment was once-daily fesoterodine 8 mg; subjects had the opportunity to receive open-label fesoterodine for ≥24 months. • After 1 month, subjects could elect dose reduction to 4 mg and subsequent re-escalation to 8 mg; dose reduction and re-escalation were each allowed once annually. • Changes in scores on the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and a Likert scale evaluating severity of bladder-related problems were assessed at open-label baseline and months 12 and 24; treatment satisfaction was assessed at open-label baseline and at months 4, 12 and 24. • A total of 864 enrolled subjects were included (men, n= 182; women, n= 682; aged fesoterodine treatment was associated with sustained improvement in measures of health-related quality of life and bladder-related problems and with high treatment satisfaction in subjects with overactive bladder symptoms. • Effects of gender and age were minimal. © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

  17. Bumetanide for the treatment of seizures in newborn babies with hypoxic ischaemic encephalopathy (NEMO) : an open-label, dose finding, and feasibility phase 1/2 trial

    NARCIS (Netherlands)

    Pressler, Ronit M.; Boylan, Geraldine B.; Marlow, Neil; Blennow, Mats; Chiron, Catherine; Cross, J. Helen; de Vries, Linda S.; Hallberg, Boubou; Hellstrom-Westas, Lena; Jullien, Vincent; Livingstone, Vicki; Mangum, Barry; Murphy, Brendan; Murray, Deirdre; Pons, Gerard; Rennie, Janet; Swarte, Renate; Toet, Mona C.; Vanhatalo, Sampsa; Zohar, Sarah

    Background Predinical data suggest that the loop-diuretic bumetanide might be an effective treatment for neonatal seizures. We aimed to assess dose and feasibility of intravenous bumetanide as an add-on to phenobarbital for treatment of neonatal seizures. Methods In this open-label, dose finding,

  18. 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...

  19. Long-term tolerability of tolterodine extended release in children 5-11 years of age : Results from a 12-month, open-label study

    NARCIS (Netherlands)

    Nijman, Rien J. M.; Borgstein, Niels G.; Ellsworth, Pamela; Siggaard, Charlotte

    2007-01-01

    Objective: To evaluate the long-term tolerability of tolterodine extended release (ER) in children (aged 5-11 yr) with urgency urinary incontinence (UUI). Methods: This was a multicenter, open-label extension of a 12-wk, double-blind, placebo-controlled study of tolterodine ER. Patients had UUI sugg

  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. Bumetanide for the treatment of seizures in newborn babies with hypoxic ischaemic encephalopathy (NEMO) : an open-label, dose finding, and feasibility phase 1/2 trial

    NARCIS (Netherlands)

    Pressler, Ronit M.; Boylan, Geraldine B.; Marlow, Neil; Blennow, Mats; Chiron, Catherine; Cross, J. Helen; de Vries, Linda S.; Hallberg, Boubou; Hellstrom-Westas, Lena; Jullien, Vincent; Livingstone, Vicki; Mangum, Barry; Murphy, Brendan; Murray, Deirdre; Pons, Gerard; Rennie, Janet; Swarte, Renate; Toet, Mona C.; Vanhatalo, Sampsa; Zohar, Sarah

    2015-01-01

    Background Predinical data suggest that the loop-diuretic bumetanide might be an effective treatment for neonatal seizures. We aimed to assess dose and feasibility of intravenous bumetanide as an add-on to phenobarbital for treatment of neonatal seizures. Methods In this open-label, dose finding, an

  2. 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…

  3. Effect of enzyme therapy and prognostic factors in 69 adults with Pompe disease : an open-label single-center study

    NARCIS (Netherlands)

    de Vries, Juna M.; van der Beek, Nadine A. M. E.; Hop, Wim C. J.; Karstens, Francois P. J.; Wokke, John H.; de Visser, Marianne; van Engelen, Baziel G. M.; Kuks, Jan B. M.; van der Kooi, Anneke J.; Notermans, Nicolette C.; Faber, Catharina G.; Verschuuren, Jan J. G. M.; Kruijshaar, Michelle E.; Reuser, Arnold J. J.; van Doorn, Pieter A.; van der Ploeg, Ans T.

    2012-01-01

    Background: Enzyme replacement therapy (ERT) in adults with Pompe disease, a progressive neuromuscular disorder, is of promising but variable efficacy. We investigated whether it alters the course of disease, and also identified potential prognostic factors. Methods: Patients in this open-label

  4. Blonanserin Augmentation of Atypical Antipsychotics in Patients with Schizophrenia-Who Benefits from Blonanserin Augmentation?: An Open-Label, Prospective, Multicenter Study

    National Research Council Canada - National Science Library

    Woo, Young Sup; Park, Joo Eon; Kim, Do-Hoon; Sohn, Inki; Hwang, Tae-Yeon; Park, Young-Min; Jon, Duk-In; Jeong, Jong-Hyun; Bahk, Won-Myong

    2016-01-01

    ...) with augmentation by blonanserin in schizophrenic patients. aA total of 100 patients with schizophrenia who were partially or completely unresponsive to treatment with an AAP were recruited in this 12-week, open-label, non-comparative, multicenter study...

  5. 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…

  6. 45 CFR 233.26 - Retrospective budgeting; determining eligibility after the initial one or two months.

    Science.gov (United States)

    2010-10-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES COVERAGE AND CONDITIONS OF ELIGIBILITY IN FINANCIAL ASSISTANCE... 45 Public Welfare 2 2010-10-01 2010-10-01 false Retrospective budgeting; determining eligibility after the initial one or two months. 233.26 Section 233.26 Public Welfare Regulations Relating to Public...

  7. Does Sentential Prosody Improve Two-Month Olds' Memory for Speech?

    Science.gov (United States)

    Mandel, Denise; And Others

    This study investigated two-month-old infants' memory for phonetic information using the high-amplitude-sucking procedure (HAS). Specifically, the study explored whether the availability of prosodic organization enhances infants' memory for the phonetic information they hear. After a baseline measure was obtained, infant sucking resulted in a…

  8. Design of the Pacemaker REmote Follow-up Evaluation and Review (PREFER trial to assess the clinical value of the remote pacemaker interrogation in the management of pacemaker patients

    Directory of Open Access Journals (Sweden)

    Johnson W Ben

    2008-04-01

    Full Text Available Abstract Background Although pacemakers are primarily used for the treatment of bradycardia, diagnostic data available in current pacemakers allow them to be also used as sophisticated, continuous monitoring devices. Easy access to these stored data may assist clinicians in making diagnostic and therapeutic decisions sooner, thus avoiding potential long-term sequelae due to untreated clinical disorders. Internet-based remote device interrogation systems provide clinicians with frequent and complete access to stored data in pacemakers. In addition to monitoring device function, remote monitors may be a helpful tool in assisting physicians in the management of common arrhythmia disorders. Methods The Pacemaker REmote Follow-up Evaluation and Review (PREFER trial is a prospective, randomized, parallel, unblinded, multicenter, open label clinical trial to determine the utility of remote pacemaker interrogation in the earlier diagnosis of clinically actionable events compared to the existing practice of transtelephonic monitoring. There have been 980 patients enrolled and randomized to receive pacemaker follow up with either remote interrogation using the Medtronic CareLink® Network (CareLink versus the conventional method of transtelephonic monitoring (TTM in addition to periodic in-person interrogation and programming evaluations. The purpose of this manuscript is to describe the design of the PREFER trial. The results, to be presented separately, will characterize the number of clinically actionable events as a result of pacemaker follow-up using remote interrogation instead of TTM. Trial registration ClinicalTrials.gov: NCT00294645.

  9. Rural-Urban Differences in the Effect of Follow-Up Care on Postdischarge Outcomes.

    Science.gov (United States)

    Toth, Matthew; Holmes, Mark; Van Houtven, Courtney; Toles, Mark; Weinberger, Morris; Silberman, Pam

    2017-08-01

    To assess rural-urban differences in quality of postdischarge care among Medicare beneficiaries, controlling for selection bias of postdischarge services. The Medicare Current Beneficiary Survey (MCBS), Cost and Use Files from 2000 to 2010, the Area Resource File, Provider of Services File, and the Dartmouth Atlas of Health Care. Retrospective analysis of 30- and 60-day hospital readmission, emergency department (ED) use, and mortality using two-stage residual inclusion; receipt of 14-day follow-up care was the main independent variable. We defined index admission from the MCBS as any admission without a previous admission within 60 days. Noninstrumental variables estimation was the preferred estimation strategy. Fourteen-day follow-up care reduced the risk of readmission, ED use, and mortality. There were no rural- urban differences in the effect of 14-day follow-up care on readmission and mortality. Rural beneficiaries experienced a greater effect of 14-day follow-up care on reducing 30-day ED use compared to urban beneficiaries. Follow-up care reduces 30- and 60-day readmission, ED use, and mortality. Rural and urban Medicare beneficiaries experience similar beneficial effects of follow-up care on the outcomes. Policies that improve follow-up care in rural settings may be beneficial. © Health Research and Educational Trust.

  10. 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.

  11. Adherence to Follow-Up Recommendations by Triathlon Competitors Receiving Event Medical Care

    Science.gov (United States)

    Lloyd, Jarem B.; Copeli, Nikoli

    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. PMID:28203462

  12. 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.

  13. Adherence to follow-up CT scans in patients with small pulmonary nodules, a retrospective study

    DEFF Research Database (Denmark)

    Johansson, Sofie Lock; Gerner Hansen, Niels-Christian

    2010-01-01

    Adherence to follow-up CT scans in patients with small pulmonary nodules, a retrospective study The Danish National guidelines have since 2008 suggested serial follow-up CT scans at 3, 6, 12, and 24 months for nodules between 5 and 10 mm and at 12 and 24 months for nodules less than 5 mm in accor...... is that management of the follow-up of small nodules did improve in 2008-2009, but adherence to the guidelines was still limited. We will now implement a prospective program for monitoring the adherence to the follow-up CTs.......Adherence to follow-up CT scans in patients with small pulmonary nodules, a retrospective study The Danish National guidelines have since 2008 suggested serial follow-up CT scans at 3, 6, 12, and 24 months for nodules between 5 and 10 mm and at 12 and 24 months for nodules less than 5 mm...... in the four year period 2006-2009. In 72 cases, 19 in 2006-2007 and 51 in 2008-2009, one or more small nodules, with diameter ≤ 10 mm, were detected on CT in patients with no known recent malignant disease. For these patients follow-up was suggested, either with CT or PET-CT. One of the 70 patients from 2008...

  14. 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.

  15. Language barriers, location of care, and delays in follow-up of abnormal mammograms.

    Science.gov (United States)

    Karliner, Leah S; Ma, Lin; Hofmann, Michael; Kerlikowske, Karla

    2012-02-01

    Breast cancer is frequently diagnosed after an abnormal mammography result. Language barriers can complicate communication of those results. We evaluated the association of non-English language with delay in follow-up. Retrospective cohort study of women at 3 mammography facilities participating in the San Francisco Mammography Registry with an abnormal mammogram result from 1997 to 2008. We measured median time from report of abnormal result to first follow-up test. Of 13,014 women with 16,109 abnormal mammograms, 4027 (31%) had a non-English patient language. Clinical facilities differed in proportion of non-English speakers and in time to first follow-up test: facility A (38%; 25 d), facility B (18%; 14 d), and facility C (51%; 41 d). Most mammography examinations (67%) had breast imaging and reporting data system 0 (incomplete) assessment, requiring radiographic follow-up. At 30 days of follow-up, 67% of all English speakers with incomplete assessments had a follow-up examination compared with 50% of all non-English speakers (Planguage; compared with English speakers and adjusting for education, non-English speakers had twice the odds ratio of >30-day delay in follow-up (odds ratio=2.3; 95% confidence interval, 1.4-3.9). There are considerable differences among facilities in delays in diagnostic follow-up of abnormal mammography results. More attention must be paid to understanding mammography facility factors, such as wait time to schedule diagnostic mammography and radiology workload, to improve rates of timely follow-up, particularly for those facilities disproportionately serving vulnerable non-English speaking patients.

  16. Language Barriers, Location of Care and Delays in Follow-up of Abnormal Mammograms

    Science.gov (United States)

    Karliner, LS; Ma, L; Hofmann, M; Kerlikowske, K

    2013-01-01

    Background Breast cancer is frequently diagnosed after an abnormal mammography result. Language barriers can complicate communication of those results. Objectives We evaluated the association of non-English language with delay in follow-up. Methods: Retrospective cohort study of women at three mammography facilities participating in the San Francisco Mammography Registry (SFMR) with an abnormal mammogram result from 1997-2008. We measured median time from report of abnormal result to first follow-up test. Results Of 13,014 women with 16,109 abnormal mammograms, 4,027 (31%) had a non-English patient language. Clinical facilities differed in proportion of non-English-speakers and in time to first follow-up test: facility A (38%; 25 days), facility B (18%; 14 days), facility C (51%; 41 days). Most (67%) mammography examinations had BIRADS 0 (incomplete) assessment, requiring radiographic follow-up. At 30 days of follow-up 67% of all English speakers with incomplete assessments had a follow-up exam compared with 50% of all non-English speakers (p30 day delay in follow-up (OR 2.3; 95 CI 1.4-3.9). Conclusions There are considerable differences among facilities in delays in diagnostic follow-up of abnormal mammography results. More attention must be paid to understanding mammography facility factors, such as wait time to schedule diagnostic mammography and radiology workload, in order to improve rates of timely follow-up, particularly for those facilities disproportionately serving vulnerable non-English speaking patients. PMID:21993060

  17. 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.

  18. Preoperative predictors of adherence to multidisciplinary follow-up care postbariatric surgery.

    Science.gov (United States)

    Larjani, Soroush; Spivak, Israel; Hao Guo, Ming; Aliarzadeh, Babak; Wang, Wei; Robinson, Sandra; Sockalingam, Sanjeev; Aarts, Mary-Anne

    2016-02-01

    Long-term multidisciplinary care after bariatric surgery is important for weight maintenance and management of co-morbidities. Despite this, the rate of attendance to follow-up appointments is universally low. To identify patient factors that contribute to adherence to follow-up care after bariatric surgery. Three university-affiliated hospitals in Canada A cohort study of 388 patients who underwent bariatric surgery from January 2011 to December 2011 was performed. This program mandates multidisciplinary follow-up care at 3, 6, and 12 months, and annually thereafter. Patients' socioeconomic, psychosocial, and medical and psychiatric co-morbidities were recorded prospectively. Adherence to follow-up care was defined as having attended the majority of clinic visits (3 or 4 out of 4); all other patients were considered nonadherent. The mean age of patients was 45.0 years, 81.2% were female, and the majority underwent a gastric bypass (91.8%) versus a sleeve gastrectomy (8.2%); 62.1% of patients were adherent to follow-up appointments. Patients older than 25 years had a higher adherence rate than those who were younger (63.2% versus 37.5%, P = .040). Patients with full-time or part-time employment had a significantly higher adherence rate than those who were unemployed or retired (65.6% versus 50.0%, P = .017, odds ratio 1.9). Patients with obstructive sleep apnea (OSA) before surgery had higher follow-up adherence than those without OSA (62.2% versus 37.8%, P = .044). In multivariate analysis, employment remained an independent predictor of follow-up adherence (P = .017). Employment was the strongest predictor of attendance to follow-up clinic. Patients with OSA and older patients were also more likely to return consistently for scheduled follow-up. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  19. 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

  20. Kyoto Conference Dinner Speech: Follow-up in the age of surveys

    CERN Document Server

    Groot, Paul J

    2010-01-01

    Future big surveys are going to provide many targets of rare compact binary populations that will require photometric and spectroscopic follow-up to use them to answer questions on the formation and evolution of compact binaries, their space densities and the connection to other astrophysical phenomena such as Supernovae Type Ia and the populations of gravitational wave emitters. Now is the time to start preparing efficient follow-up strategies for upcoming static and synoptic surveys. The proposal is to develop a standard photometer that will facilitate a homogeneous multi-band follow-up strategy.

  1. Association between subjective memory complaints and nursing home placement: a four-year follow-up

    DEFF Research Database (Denmark)

    Waldorff, Frans Boch; Siersma, Volkert; Waldemar, Gunhild

    2009-01-01

    OBJECTIVE: In order to evaluate whether elderly persons with subjective memory complaints may be regarded as a group of potentially vulnerable patients who need close follow-up, we investigated the risk of nursing home placement during a 4-year follow-up period. METHODS: Prospective cohort survey...... with 4-year follow-up in general practice. Cox proportional hazard models were used to examine the influence of risk factors on nursing home placement. RESULTS: A total 758 non-nursing home residents aged 65 years and older consulted the General Practitioners in October and November 2002 of whom 50...

  2. Pi of the Sky involvement in LSC-Virgo electromagnetic follow-up project

    Science.gov (United States)

    ZadroŻny, Adam; Sokołowski, Marcin; Mankiewicz, Lech; Żarnecki, Aleksander Filip

    2016-09-01

    Pi of the Sky took part in LSC-Virgo's Electromagnetic (EM) Follow-up project during first science run of Advanced LIGO detectors between September 2015 and January 2016. More than 60 astronomical teams have signed Memorandum-of-Understanding with LSC-Virgo for EM Follow-up project. LSC-Virgo's EM Follow-up is aimed for searching electromagnetic counterparts to gravitational wave transient candidates. Observing an event both in EM and gravitational wave band might be a important step forward to multi-messenger astronomy. The aim of this paper is to show algorithms used by Pi of the Sky for analysing data taken during the science runs.

  3. 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...

  4. Follow-up research of moose and other wild animals at Pernaja European Highway E18

    OpenAIRE

    Vare, Seija

    2001-01-01

    The follow up study at Pernaja has continued now for nearly three years. The follow up research has been started before the road was built, it continued during the construction period 1995 -1998. The amounts of animals and the traces of animals were examined. The semi -motorway was opened to traffic in the year 1998, and then started the follow - up research at under passages. At the road there were 11 under passages, which were built for local traffic, but they were suitable also for animals...

  5. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial

    Directory of Open Access Journals (Sweden)

    Caihong Sun

    2016-06-01

    Full Text Available 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.

  6. Effects of risperidone on core symptoms of autistic disorder based on childhood autism rating scale: An open label study

    Directory of Open Access Journals (Sweden)

    Padideh Ghaeli

    2014-01-01

    Full Text Available Background: 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. Materials and Methods: 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. Results: 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 (P<0.001, P=0.03, respectively. However, stereotypic behaviors did not show any significant change in this study. Increase in appetite and somnolence were the most reported side effects. Conclusion: This study suggests that risperidone may be an effective treatment for the management of core symptoms of autistic disorder.

  7. Reduction of tinnitus severity by the centrally acting muscle relaxant cyclobenzaprine: an open-label pilot study.

    Science.gov (United States)

    Coelho, Claudia; Figueiredo, Ricardo; Frank, Elmar; Burger, Julia; Schecklmann, Martin; Landgrebe, Michael; Langguth, Berthold; Elgoyhen, Ana Belen

    2012-01-01

    Tinnitus, the phantom perception of sounds, is a highly prevalent disorder. Although a wide variety of drugs have been investigated off label for the treatment of tinnitus, there is no approved pharmacotherapy. We report an open-label exploratory pilot study to assess the effect of muscle relaxants acting on the central nervous system on tinnitus patients. Cyclobenzaprine at high (30 mg) and low doses (10 mg), orphenadrine (100 mg), tizanidine (24 mg) and eperisone (50 mg) were administered to a maximum of 20 patients per group over a 12-week period. High-dose cyclobenzaprine resulted in a significant reduction in the Tinnitus Handicap Inventory (THI) score between baseline and week 12 in the intention-to-treat sample. On the other hand, other treatments were not effective. These results were confirmed in an explorative analysis where baseline corrected THI and Clinical Global Impression scores at week 12 were compared between groups. The present open trial presents a new promising pharmacotherapy for tinnitus that should be validated in placebo-controlled double-blind trials.

  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. 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....

  10. Adalimumab induction therapy for ulcerative colitis with intolerance or lost response to infliximab: An open-label study

    Institute of Scientific and Technical Information of China (English)

    Laurent Peyrin-Biroulet; Cécils Laclotte; Xavier Roblin; Marc-André Bigard

    2007-01-01

    AIM: To evaluate the efficacy of adalimumab induction therapy in patients with ulcerative colitis who previously responded to infliximab and then lost response or became intolerant.METHODS: Ten patients with ulcerative colitis were enrolled in a 4-wk open-label trial. The patients received a loading dose of 160 mg adalimumab at wk 0 followed by 80 mg at wk 2. The primary efficacy measure was clinical improvement at wk 4, as defined by a decrease in clinical activity index (CAI) of more than 4.RESULTS: Four of 10 patients (40%) benefited from subsequent adalimumab therapy; one patient achieved remission (CAI < 4) and 3 had clinical improvement at wk 4. 6 patients had no response (60%); 2 of 6 (33.3%) subsequently underwent colectomy. This was accompanied by a decrease in median CRP concentration from 16.8 mg/mL at baseline to 3.85 mg/mL at wk 4, excluding two patients who underwent colectomy after two infusions of adalimumab. Among the 6 patients with severe colitis (CAI > 12) at baseline, none achieved remission and only one patient had clinical improvement at wk 4.CONCLUSION: The small advantage of adalimumab in patients with mild to moderate ulcerative colitis and lost response or intolerance to infliximab needs to be confirmed in randomised, double-blind, placebocontrolled trials.

  11. An Open-Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity

    Science.gov (United States)

    Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G.

    2011-01-01

    Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans. PMID:22164340

  12. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study

    Science.gov (United States)

    Wyndaele, J-J; Goldfischer, E R; Morrow, J D; Gong, J; Tseng, L-J; Guan, Z; Choo, M-S

    2009-01-01

    Aims: To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder (OAB) who were dissatisfied with previous tolterodine treatment. Methods: This was a 12-week, open-label, flexible-dose study of adults with OAB (≥ 8 micturitions and ≥ 3 urgency episodes per 24 h) who had been treated with tolterodine (immediate- or extended-release) for OAB within 2 years of screening and reported dissatisfaction with tolterodine treatment. Subjects received fesoterodine 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on the subject’s and physician’s subjective assessment of efficacy and tolerability. Subjects completed 5-day diaries, the Patient Perception of Bladder Condition (PPBC) and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12 and rated treatment satisfaction at week 12 using the Treatment Satisfaction Question (TSQ). Safety and tolerability were assessed. Results: Among 516 subjects treated, approximately 50% opted for dose escalation to 8 mg at week 4. Significant improvements from baseline to week 12 were observed in micturitions, urgency urinary incontinence episodes, micturition-related urgency episodes and severe micturition-related urgency episodes per 24 h (all pfesoterodine significantly improved OAB symptoms, HRQL, and rates of treatment satisfaction and was well tolerated in subjects with OAB who were dissatisfied with prior tolterodine therapy. PMID:19348029

  13. A multicenter, open-label, 52-week study of 2% rebamipide (OPC-12759) ophthalmic suspension in patients with dry eye.

    Science.gov (United States)

    Kinoshita, Shigeru; Awamura, Saki; Nakamichi, Norihiro; Suzuki, Hiroyuki; Oshiden, Kazuhide; Yokoi, Norihiko

    2014-03-01

    To investigate the efficacy and safety of 2% rebamipide ophthalmic suspension administered 4 times daily for 52 weeks in patients with dry eye. Multicenter (17 sites), open-label, single-arm study. A total of 154 patients with dry eye were enrolled in this study. After a 2-week screening period, patients received 2% rebamipide, instilled as 1 drop in each eye, 4 times daily for 52 weeks. The signs and symptoms measures were assessed at baseline, at weeks 2 and 4, and at every 4 weeks thereafter. The objective signs were fluorescein corneal staining score, lissamine green conjunctival staining score, and tear film break-up time, while subjective symptoms were dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision). The safety variable was the occurrence of adverse events. For all objective signs and subjective symptoms, the scores significantly improved at week 2 compared with baseline (P rebamipide is effective in improving both the objective signs and subjective symptoms of dry eye patients for at least 52 weeks. In addition, 2% rebamipide treatment was generally well tolerated. Copyright © 2014. Published by Elsevier Inc.

  14. Effect of topical vitamin D on chronic kidney disease-associated pruritus: An open-label pilot study.

    Science.gov (United States)

    Jung, Kyung Eun; Woo, Yu Ri; Lee, Joong Sun; Shin, Jong Ho; Jeong, Jin Uk; Koo, Dae Won; Bang, Ki Tae

    2015-08-01

    Chronic kidney disease-associated pruritus (CKD-aP) is a troublesome symptom in patients with end-stage renal disease (ESRD). Recently, vitamin D deficiency has been known to be one of the possible etiologic factors in CKD-aP. However, limited data is available on whether topical vitamin D treatment is effective for relieving CKD-aP. Therefore, the purpose of this study is to evaluate the effectiveness of topically vitamin D for CKD-aP. Twenty-three patients with CKD-aP were enrolled in a single center, open-label study. Patients were instructed to apply a topical vitamin D (calcipotriol) agent (Daivonex solution; LEO Pharma) or vehicle solution twice daily for a month. We assessed the efficacy and safety of topical vitamin D on CKD-aP using clinical and dermoscopic photographs, and questionnaires including the validated modified pruritus assessment score (VMPAS) and visual analog scale (VAS) every 2 weeks. Dry dermoscopic findings showed significant improvement of scale (dryness) on the skin of topical vitamin D-treated patients compared with those of the vehicle group. Both VMPAS and VAS were significantly decreased after 2 and 4 weeks of the topical vitamin D treatment compared with the vehicle, respectively (P < 0.05). No significant side-effects were observed. Topical vitamin D may be one of the safe and effective therapeutic candidates for CKD-aP.

  15. Treprostinil sodium (Remodulin), a prostacyclin analog, in the treatment of critical limb ischemia: open-label study.

    Science.gov (United States)

    Berman, Scott; Quick, Rhonda; Yoder, Pam; Voigt, Sonia; Strootman, Deborah; Wade, Michael

    2006-01-01

    The purpose of this study was to assess the safety of continuous subcutaneous therapy with treprostinil sodium (Remodulin), a prostacyclin analog, and its effect on ischemic rest pain and ischemic wound healing in subjects with critical limb ischemia (CLI) and no planned revascularization procedure. This was a 12-week, open-label, single-center pilot study enrolling 10 subjects (mean age 82.4 years) with Fontaine stage III to IV (Rutherford class 4-6) peripheral arterial disease and ankle brachial indices less than 0.55. The primary end point was safety, and the secondary end points were the effects of treatment on ischemic rest pain, limb salvage, and wound healing. There was a 62% reduction in mean worst rest pain and a 57% reduction in mean average rest pain at week 12, with most subjects using less pain medication. Three subjects experienced complete healing of their wounds. No subject developed a new wound during the trial. Treprostinil was generally well tolerated. Subcutaneous infusion-site pain was the most frequently reported side effect, with one subject withdrawing from the study as a result. Jaw pain was reported by two subjects. One subject experienced two serious adverse events considered unrelated to treprostinil (cholecystitis and congestive heart failure). This study demonstrates that chronic, continuous subcutaneous treprostinil is safe and can be useful in the treatment of ischemic pain and wounds in subjects with CLI. Future controlled studies are needed to evaluate these effects and determine appropriate patient selection.

  16. An Open Label, Phase 2 Study of MABp1 Monotherapy for the Treatment of Acne Vulgaris and Psychiatric Comorbidity.

    Science.gov (United States)

    Carrasco, Daniel; Stecher, Michael; Lefebvre, Gigi Claire; Logan, Alan C; Moy, Ronald

    2015-06-01

    Acne vulgaris is a common inflammatory skin disorder. There remain few rapid, safe, and effective therapy options for patients with moderate to severe acne vulgaris that also address psychological comorbidities such as anxiety. To assess the efficacy of interleukin 1 alpha blockade in patients with moderate to severe acne vulgaris using the true human monoclonal antibody MABp1. Eleven patients were administered open-label, subcutaneous injections of MABp1 over a six-week period. Objectives were assessment of safety, change in inflammatory lesion count and change in psychosocial functioning using two validated questionnaires. There were no serious adverse events, or adverse events greater than grade I. Median inflammatory lesion counts decreased 36% (IQR -44% to 1%). Anxiety scores improved (from median 6 to 1) as well as self-image assessment (2.3±0.9 to 2.1±0.1) as measured by the Hospital Anxiety and Depression Scale and the modified Body Image Disturbance Questionnaire. Patients had rapid improvement of skin lesions, as well as psychosocial functioning and anxiety. MABp1 may provide a safe and effective means for treating inflammatory acne lesions and. Further studies using this antibody are warranted in this patient population.

  17. Pharmacokinetics, safety, and tolerability of a depot formulation of naltrexone in alcoholics: an open-label trial

    Directory of Open Access Journals (Sweden)

    Koch Monika

    2005-04-01

    Full Text Available Abstract Background Naltrexone is an effective medication for treatment of alcohol dependence, but its efficacy is limited by lack of adherence to the oral dosage form. A long-acting depot formulation of naltrexone may increase adherence. Methods A single site, 6-week open label study was conducted with 16 alcohol dependent subjects each receiving 300 mg of Naltrexone Depot by intramuscular injection. The main outcomes were safety and tolerability of the Naltrexone Depot formulation, blood levels of naltrexone and its main metabolite 6-beta naltrexol, and self-reported alcohol use. All subjects received weekly individual counseling sessions. Results The medication was well tolerated with 88% of subjects completing the 6-week trial. The most common side effect experienced was injection site complications. There were no serious adverse events. Subjects had naltrexone and 6-beta-naltrexol concentrations throughout the trial with mean values ranging from 0.58 ng/mL to 2.04 ng/mL and 1.51 ng/mL to 5.52 ng/mL, respectively, at each sampling time following administration. Compared to baseline, subjects had significantly reduced number of drinks per day, heavy drinking days and proportion of drinking days. Conclusion Naltrexone Depot is safe and well tolerated in alcoholics and these findings support the further investigation of its utility in larger double-blind placebo controlled trials.

  18. 4-WEEK OPEN-LABEL CONTROLLED RANDOMIZED COMPARATIVE STUDY OF THE INJECTABLE AND TABLETTED FORMULATIONS OF METHOTREXATE IN RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    Yu. V. Muravyev

    2011-01-01

    Full Text Available Objective: to estimate the advantages and disadvantages of using the injectable formulation of methotrexate (MT (Methoject (MTJ in rheumatoid arthritis (RA in clinical practice. Subjects and methods. A 24-week open-label controlled randomized comparative study evaluated the therapeutic and side effects of MTJ and methotrexate tablets in RA and clarified whether MTJ treatment might be continued if its tabletted formulation was discontinued because of adverse reactions. Results and discussion. MTJ was found to be more effective than the tabletted formulation of MT and as a whole; and following 3-month therapy, more patients receiving MTJ achieved an ACR20 response. The advantage of MTJ was also retained 6 months after therapy. Higher transaminase levels were noted in 2 patients, one in each group. Switching from MT to MTJ noticeably reduced the number of adverse reactions in the majority of patients from an additional group. Conclusion. As compared to MT, MTJ used in RA patients is more effective when given in an equivalent dose, exerts a therapeutic effect more rapidly, and induces adverse gastrointestinal reactions less frequently. 

  19. Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study.

    Science.gov (United States)

    Petersenn, Stephan; Bollerslev, Jens; Arafat, Ayman M; Schopohl, Jochen; Serri, Omar; Katznelson, Laurence; Lasher, Janet; Hughes, Gareth; Hu, Ke; Shen, George; Reséndiz, Karina Hermosillo; Giannone, Vanessa; Beckers, Albert

    2014-11-01

    Pasireotide (SOM230), a multireceptor-targeted somatostatin analogue, has exhibited favorable safety/tolerability in several clinical studies. A long-acting-release (LAR) formulation of pasireotide may offer advantages over the subcutaneous formulation. This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study. Steady-state pasireotide concentrations were achieved following three monthly injections. Trough pasireotide concentrations (ng/mL) 28 days after each injection were: 2.48, 4.16, and 3.10 (20 mg group); 6.42, 6.62, and 7.12 (40 mg group); and 9.51, 11.7, and 13.0 (60 mg group). At study end, 51% and 57% of patients achieved GH levels ≤2.5 μg/L and IGF-1 levels below ULN, respectively. Compared with baseline, fasting blood glucose and HbA1c levels increased, whereas fasting blood insulin levels decreased. Acromegaly symptoms were generally improved. Adverse events were mostly gastrointestinal and mild/moderate. Pasireotide LAR was generally well tolerated. Steady-state PK was achieved after three monthly doses; exposures were approximately dose proportional. Control of GH, IGF-1, and symptoms improved, suggesting that pasireotide LAR may be an effective treatment for acromegaly.

  20. Patient follow up screening evaluations. Examples with regard to congenital hip dislocation and congenital heart disease

    NARCIS (Netherlands)

    R.E. Juttmann (Rikard); J. Hess (Jakob); P.J. van der Maas (Paul); G.J. van Oortmarssen (Gerrit)

    2001-01-01

    textabstractOBJECTIVE: To discuss the merits of the patient follow up study design for the evaluation of some specific mass screening programmes. DESIGN: Theoretical evaluation illustrated by two examples. SETTING: Department of Public Health Erasmus University

  1. 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.

  2. Parental education on asthma severity in the emergency department and primary care follow-up rates.

    Science.gov (United States)

    Williams, Kelli W; Word, Carolyn; Streck, Maria R; Titus, M Olivia

    2013-07-01

    Asthma is the most prevalent chronic condition affecting children and a common chief complaint in emergency departments (EDs). We aimed to improve parents' understanding of their child's asthma severity on accessing our pediatric ED for an acute asthma exacerbation. A retrospective chart review was conducted to determine outpatient follow-up rates from our ED in 2010-2011. In an attempt to educate parents at ED discharge about their child's asthma severity at presentation, we included a visual severity scale on their discharge instructions. Postdischarge telephone interviews were completed to determine postintervention follow-up rates. Asthma follow-up rates at 1 week improved from 20.8% to 50% after intervention. This difference was statistically significant after controlling for age and clinical asthma score with logistic regression (P education about a child's initial asthma severity is a simple intervention that significantly improved follow-up rates for children seen in the ED for asthma exacerbation.

  3. Benefits of and barriers to SEA follow-up - Theory and practice

    Energy Technology Data Exchange (ETDEWEB)

    Gachechiladze-Bozhesku, M., E-mail: mayagachechiladze@gmail.com [Center for Environment and Security, Central European University, Nador ut. 9, Budapest 1051 (Hungary); Fischer, T.B., E-mail: fischer@liverpool.ac.uk [School of Environmental Sciences, 4imPiAct research team, University of Liverpool, Liverpool, 74 Bedford Street South, Liverpool L69 7ZQ (United Kingdom)

    2012-04-15

    If SEA is to facilitate 'strategic' changes, it needs to focus on shaping the ways in which strategic initiatives are implemented, not just formulated. This is why follow-up which refers to postdecisional activities of SEA and strategic initiatives is increasingly seen as crucial. However, to date follow-up has only received limited attention in the SEA literature, as well as in practical guidance. The key reasons for why post decision activities are often overlooked are the lack of understanding of its actual benefits and purportedly multiple problems with its accomplishment. This paper reports on the results of a comprehensive literature review and an international e-survey on the topic, as well as an in-depth analysis of six SEA follow-up cases from England and Canada. Practically encountered and perceived benefits of, and obstacles to SEA follow-up are identified and discussed.

  4. 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....

  5. [Feasibility of following up a representative sample of the adult population in Barcelona (Spain)].

    Science.gov (United States)

    Martínez-Sánchez, Jose M; Fu, Marcela; Sureda, Xisca; Ballbè, Montse; Riccobene, Anna; Fernández, Esteve

    2013-01-01

    The objective of this work was to study the feasibility of following up a representative sample of the adult population of Barcelona 8 years after the baseline study. We selected a random sample (n=100) of the 1161 participants who consented to be re-contacted. We contacted 66 participants: 52 (78.8%) agreed to participate in the follow-up, three (4.5%) had died, four (6.1%) had moved, and seven (10.6%) declined to participate in the follow-up. The participation rate in the feasibility study was 52%. In conclusion, the results of our study show a good feasibility of conducting a follow-up study 8 years after the baseline study. Copyright © 2012 SESPAS. Published by Elsevier Espana. All rights reserved.

  6. Ultrasonographic features of vascular closure devices: initial and 6-month follow-up results

    Directory of Open Access Journals (Sweden)

    Hye Jung Choo

    2014-10-01

    Initial ultrasonographic evaluation reflected the unique structure of each VCD, with most of them being easily distinguishable. Follow-up ultrasonography revealed various changes in the affected vessels.

  7. 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).

  8. 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...... better school abilities and came more often from homes with two adults, higher income or higher educational level. These differences increased at subsequent follow-ups. The effect of initial non-participation on the ORs was modest with most RORs being close to one. Loss to follow-up led to larger...... variations in the RORs ranging from 0.77 to 1.62 although for most estimates, the bias was minor. None of the measured RORs were statistically different from one indicating no significant bias. CONCLUSIONS: Although certain characteristics were related to those who initially chose to participate...

  9. 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.

  10. Two-year follow-up of self-examination therapy for generalized anxiety disorder.

    Science.gov (United States)

    Floyd, Mark; McKendree-Smith, Nancy; Bailey, Elaine; Stump, Jamie; Scogin, Forrest; Bowman, Daniel

    2002-01-01

    This study examined the stability of treatment gains after receiving self-examination therapy (SET) [Bowman, D. (1995). Innovations in clinical practice: a source book. Professional Resource Press.] for generalized anxiety disorder. A 2-year follow-up of 16 participants from Bowman, Scogin, Floyd, Patton, and Gist [J. Counsel. Psychol. 44 (1997) 267] was conducted by comparing pre- and post-treatment measures with follow-up measures from the Hamilton Anxiety Rating Scale-Revised (HARS-R), the State-Trait Anxiety Inventory (STAI), and the SET quiz. Results indicated treatment gains from baseline to the 2-year follow-up period were maintained on all measures, and there was not a significant decline from post-treatment to follow-up on the HARS-R and STAI. These results suggest that SET for treatment of generalized anxiety disorder (GAD) may be effective in both the immediate and long-term reduction of GAD symptoms.

  11. Use of mobile phones to improve post-hospitalisation follow-up of ...

    African Journals Online (AJOL)

    ... suggest that a substantial proportion of re-admissions are preventable through effective discharge planning and close patient follow up. ... Design: A cross sectional study. Setting: Siaya County Health facilities, in Nyanza province, Kenya.

  12. 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.

  13. Suicide risk in schizophrenia – a follow-up study after 20 years ...

    African Journals Online (AJOL)

    Suicide risk in schizophrenia – a follow-up study after 20 years. ... South African Journal of Psychiatry. Journal Home · ABOUT ... Crosstabulations were then performed to identify factors associated with increased suicide risk. For those subjects ...

  14. 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...

  15. Echocardiographic Follow-up of Robotic Mitral Valve Repair for Mitral Regurgitation due to Degenerative Disease

    Directory of Open Access Journals (Sweden)

    Yao Wang

    2016-01-01

    Conclusion: Robotic MV repair for MR due to degenerative disease is associated with a low rate of recurrent MR, and a significant improvement in MR grade, LAD, and LVEDD, but a significant decrease in LVEF at echocardiographic follow-up.

  16. 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: Treate...

  17. Long-Term follow up after intra-Uterine transfusionS; the LOTUS study

    National Research Council Canada - National Science Library

    Verduin, Esther P; Lindenburg, Irene T M; Smits-Wintjens, Vivianne E H J; van Klink, Jeanine M M; Schonewille, Henk; van Kamp, Inge L; Oepkes, Dick; Walther, Frans J; Kanhai, Humphrey H H; Doxiadis, Ilias I N; Lopriore, Enrico; Brand, Anneke

    2010-01-01

    .... We set up a large long-term observational follow-up study (LOTUS study), in cooperation with the Sanquin Blood Supply Foundation and the LUMC departments of Obstetrics, Neonatology and ImmunoHematology...

  18. 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

    2016-01-01

    to face or by phone by a field assistant and patients were asked why they had not shown up for the scheduled appointment. Patients were included by date of HIV testing and risk factors for LTFU were assessed using Cox proportional hazard model. Results: Among 561 patients (69.5 % HIV-1, 18.0 % HIV-2......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......, 2013, and January 31, 2014. Patients lost to follow-up, who lived within the area of the Bandim Health Project, a demographic surveillance site (DSS), were eligible for inclusion. Active follow-up was attempted by telephone and tracing by a field assistant. Semi-structured interviews were done face...

  19. 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...

  20. Course of adolescent headache: 4-year annual face-to-face follow-up study

    OpenAIRE

    Karlı, Necdet; Bican, Aylin; Zarifoğlu, Mehmet

    2010-01-01

    The objective of this study is to investigate the course of the diagnosis and characteristics of headache in 12- to 17-year-old adolescents during a follow-up period of 4 years. Headache prevalence and characteristics, and even the type of headache show important changes during adolescence. The course of adolescent headache might reveal important insight into the pathophysiology of headache. Subjects who received a single headache diagnosis were invited to participate in a follow-up study con...

  1. Outcome of knee injuries in general practice: 1-year follow-up

    OpenAIRE

    2010-01-01

    Background Knee injuries may lead to pain and to functional limitations in the activities of daily living. Patients with knee injuries are frequently seen in general practice; however, the outcome and management in these patients is not known. Aim To assess the outcome and management of knee injuries at 12 months' follow-up in general practice. Design of study A prospective observational cohort study with a 1-year follow-up. Setting. Primary health care. Method Adult patients consulting their...

  2. Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies.

    Science.gov (United States)

    Hill, Karl G; Woodward, Danielle; Woelfel, Tiffany; Hawkins, J David; Green, Sara

    2016-10-01

    Preventive interventions are often designed and tested with the immediate program period in mind, and little thought that the intervention sample might be followed up for years or even decades beyond the initial trial. However, depending on the type of intervention and the nature of the outcomes, long-term follow-up may well be appropriate. The advantages of long-term follow-up of preventive interventions are discussed and include the capacity to examine program effects across multiple later life outcomes, the ability to examine the etiological processes involved in the development of the outcomes of interest, and the ability to provide more concrete estimates of the relative benefits and costs of an intervention. In addition, researchers have identified potential methodological risks of long-term follow-up such as inflation of type 1 error through post hoc selection of outcomes, selection bias, and problems stemming from attrition over time. The present paper presents a set of seven recommendations for the design or evaluation of studies for potential long-term follow-up organized under four areas: Intervention Logic Model, Developmental Theory and Measurement Issues; Design for Retention; Dealing with Missing Data; and Unique Considerations for Intervention Studies. These recommendations include conceptual considerations in the design of a study, pragmatic concerns in the design and implementation of the data collection for long-term follow-up, as well as criteria to be considered for the evaluation of an existing intervention for potential for long-term follow-up. Concrete examples from existing intervention studies that have been followed up over the long term are provided.

  3. 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.

    2010-01-01

    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,…

  4. Sleep complaints in adolescent depression: one year naturalistic follow-up study

    OpenAIRE

    Anna S. Urrila; Karlsson, Linnea; Kiviruusu, Olli; Pankakoski, Maiju; Pelkonen, Mirjami; Strandholm, Thea; Marttunen, Mauri; ,

    2014-01-01

    Background Sleep complaints are highly prevalent in adolescents suffering from major depressive disorder (MDD). The aims of this study were to describe the longitudinal course of sleep complaints, and to assess the association between sleep complaints and clinical outcome in a sample of adolescents with MDD during naturalistic follow-up. Methods A sample of adolescent outpatients (n = 166; age 13–19 years, 17.5% boys) diagnosed with MDD was followed-up during one year in naturalistic settings...

  5. Bilateral Ovarian Torsion during Follow-up for Antenatally Detected Ovarian Cysts.

    Science.gov (United States)

    Zupancic, Bozidar; Baskovic, Marko; Sovic, Ljudevit; Habek, Dubravko

    2017-01-01

    Ovarian torsion is a surgical emergency demanding timely diagnosis and treatment to prevent loss of the ovaries which if happens may result in functional and emotional consequences. Simple (less than 5cm in size) ovarian cysts require follow-up for potential self-resolution. We describe a case of antenatally detected bilateral ovarian cysts that developed bilateral ovarian torsions on follow-up, postnatally.

  6. 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.

  7. The Experience of Melanoma Follow-Up Care: An Online Survey of Patients in Australia

    OpenAIRE

    Janine Mitchell; Peta Callaghan; Jackie Street; Susan Neuhaus; Taryn Bessen

    2014-01-01

    Investigating patients’ reports on the quality and consistency of melanoma follow-up care in Australia would assist in evaluating if this care is effective and meeting patients’ needs. The objective of this study was to obtain and explore the patients’ account of the technical and interpersonal aspects of melanoma follow-up care received. An online survey was conducted to acquire details of patients’ experience. Participants were patients treated in Australia for primary melanoma. Qualitative...

  8. Six-Year Experience of a Nurse-Led Colorectal Cancer Follow-Up Clinic

    OpenAIRE

    2014-01-01

    Aims and Objectives. To review the experience of a nurse-led colorectal cancer follow-up clinic in a tertiary referral colorectal cancer centre. Methodology. Data from the nurse-led colorectal cancer follow-up clinic in our unit was prospectively maintained in a colorectal cancer database. Data was analysed from January 1, 2006 until the December 31, 2011. Results. 1125 patients were diagnosed with colorectal cancer, and referred to our unit as a tertiary centre for specialised colorectal can...

  9. Recorded interactive seminars and follow-up discussions as an effective method for distance learning.

    Science.gov (United States)

    Miller, Kenneth T; Hannum, Wallace M; Proffit, William R

    2011-03-01

    Previous studies have suggested that, although orthodontic residents prefer to be live and interactive in a seminar, they learn almost as much when watching a previously recorded interactive seminar and following up with live discussion. Our objective was to test the effectiveness and acceptability of using previously recorded interactive seminars and different types of live follow-up discussions. Residents at schools participating from a distance completed preseminar readings and at their convenience watched streaming video of some or all recordings of 4 interactive seminar sequences consisting of 6 seminars each. Afterward, distant residents participated in 1 of 4 types of interaction: local follow-up discussion, videoconference, teleconference, and no discussion. The effectiveness of the seminar sequences was tested by pretest and posttest scores. Acceptability was evaluated from ratings of aspects of the seminar and discussion experience. Open-ended questions allowed residents to express what they liked and to suggest changes in their experiences. In each seminar sequence, test scores of schools participating through recordings and follow-up discussions improved more than those participating live and interactive. After viewing, residents preferred local follow-up discussion, which was not statistically different from participating live and interactive both locally and from a distance. Videoconference and teleconference discussions were both more acceptable to residents than no follow-up discussion, which was found to be significantly below all methods tested. When residents are live and interactive in a seminar, there does not appear to be a significant difference between being local vs at a distance. Recorded interactive seminars with follow-up discussions are also an effective and acceptable method of distance learning. Residents preferred local follow-up discussion, but, at a distance, they preferred videoconference to both teleconference and no discussion

  10. Laboratory guidelines for the diagnosis and follow-up of patients with monoclonal gammopathies.

    Science.gov (United States)

    Bravo García-Morato, M; Padilla-Merlano, B; Nozal, P; Espiño, M; Juárez, C; Villar, L M; López-Trascasa, M

    2016-04-01

    We present guidelines from the Immunochemistry group of the Spanish Society for Immunology that are designed to provide a practical tool for the diagnosis and follow-up of monoclonal gammopathies. We review the clinical and analytical features of various monoclonal gammopathies, international consensus guidelines and techniques used to detect and follow-up monoclonal components. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  11. Irreversible Electroporation of Malignant Hepatic Tumors--Alterations in Venous Structures at Subacute Follow-Up and Evolution at Mid-Term Follow-Up.

    Directory of Open Access Journals (Sweden)

    Marco Dollinger

    Full Text Available To evaluate risk factors associated with alterations in venous structures adjacent to an ablation zone after percutaneous irreversible electroporation (IRE of hepatic malignancies at subacute follow-up (1 to 3 days after IRE and to describe evolution of these alterations at mid-term follow-up.43 patients (men/women, 32/11; mean age, 60.3 years were identified in whom venous structures were located within a perimeter of 1.0 cm of the ablation zone at subacute follow-up after IRE of 84 hepatic lesions (primary/secondary hepatic tumors, 31/53. These vessels were retrospectively evaluated by means of pre-interventional and post-interventional contrast-enhanced magnetic resonance imaging or computed tomography or both. Any vascular changes in flow, patency, and diameter were documented. Correlations between vascular change (yes/no and characteristics of patients, lesions, and ablation procedures were assessed by generalized linear models.191 venous structures were located within a perimeter of 1.0 cm of the ablation zone: 55 (29% were encased by the ablation zone, 78 (41% abutted the ablation zone, and 58 (30% were located between 0.1 and 1.0 cm from the border of the ablation zone. At subacute follow-up, vascular changes were found in 19 of the 191 vessels (9.9%, with partial portal vein thrombosis in 2, complete portal vein thrombosis in 3, and lumen narrowing in 14 of 19. At follow-up of patients with subacute vessel alterations (mean, 5.7 months; range, 0 to 14 months thrombosis had resolved in 2 of 5 cases; vessel narrowing had completely resolved in 8 of 14 cases, and partly resolved in 1 of 14 cases. The encasement of a vessel by ablation zone (OR = 6.36, p<0.001, ablation zone being adjacent to a portal vein (OR = 8.94, p<0.001, and the usage of more than 3 IRE probes (OR = 3.60, p = 0.035 were independently associated with post-IRE vessel alterations.Venous structures located in close proximity to an IRE ablation zone remain largely

  12. Four years follow-up of 101 children with melamine-related urinary stones.

    Science.gov (United States)

    Yang, Li; Wen, Jian Guo; Wen, Jian Jun; Su, Zhi Qiang; Zhu, Wen; Huang, Chen Xu; Yu, Si Long; Guo, Zhan

    2013-06-01

    The melamine-contaminated milk powder incidence occurred in China in 2008. Many studies have been published regarding the epidemiology, clinical symptoms, diagnosis and treatment of melamine-related urinary stones. The objective of this study is to follow-up the effects of melamine-contaminated milk powder consumption on kidney and body growth in children with melamine-related urinary stones 4 years ago. One hundred and one children with melamine-related urinary stones were followed up by urinalysis, renal function tests and urinary ultrasonography. The data of body weight and height, clinical signs and complications were collected. Eighty normal children without the history of consuming melamine-contaminated milk powder were collected as controls. Eighty-one children with melamine-related urinary stones were successfully followed up. Of 45 cases with melamine-related urinary stones treated conservatively after discharge, 34 disappeared completely, 6 dissolved partially, 1 increased in size and 4 did not change at 4 years follow-up. The percentages of under-height and under-weight infants were significantly higher in melamine-related urinary stones group compared to the controls, respectively (p urinary stones on kidney and bladder was found at 4 years follow-up. However, whether or not melamine-related urinary stones had effect on body growth needs follow-up in future.

  13. Radiofrequency Ablation of Renal Tumors: Four-Year Follow-Up Results in 47 Patients

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Soo Dong; Yoon, Seong Guk; Sung, Gyung Tak [Dong-A University College of Medicine, Busan (Korea, Republic of)

    2012-09-15

    To retrospectively evaluate the intermediate results of radiofrequency ablation (RFA) of small renal masses (SRMs). Percutaneous or laparoscopic RFA was performed on 48 renal tumors in 47 patients. The follow-up studies included a physical examination, chest radiography, creatinine level, and contrast-enhanced CT or MRI. To confirm the pathologic criteria of complete ablation, 35 patients underwent a follow-up biopsy. Recurrence was defined as contrast enhancement on imaging studies after 3 months, lesion growth at subsequent imaging, or viable cancer cells on follow-up biopsy. Technical success was achieved in 43 (89.6%) of 48 renal tumors. The mean tumor size was 2.3 cm and the mean follow-up period was 49.6 months. Repeated RFA was necessary in 5 tumors due to incomplete ablation. The overall complication rate was 35.8%, of which 96.2% were mild complications. Serum creatinine levels at 12 months after RFA did not differ from those before RFA (1.28 vs. 1.36 mg/dL). Four patients were found to have recurrence at various follow-up intervals, and distant metastasis was not found in any cases. RFA appears to be a useful treatment for selected patients with SRMs. Our 4-year follow-up results disclose an excellent therapeutic outcome with RFA, while achieving effective local tumor control.

  14. Cohort profile of the Japan Collaborative Cohort Study at final follow-up.

    Science.gov (United States)

    Tamakoshi, Akiko; Ozasa, Kotaro; Fujino, Yoshihisa; Suzuki, Koji; Sakata, Kiyomi; Mori, Mitsuru; Kikuchi, Shogo; Iso, Hiroyasu; Sakauchi, Fumio; Motohashi, Yutaka; Tsuji, Ichiro; Nakamura, Yosikazu; Mikami, Haruo; Kurosawa, Michiko; Hoshiyama, Yoshiharu; Tanabe, Naohito; Tamakoshi, Koji; Wakai, Kenji; Tokudome, Shinkan; Hashimoto, Shuji; Wada, Yasuhiko; Kawamura, Takashi; Watanabe, Yoshiyuki; Miki, Tsuneharu; Date, Chigusa; Kurozawa, Yoichi; Yoshimura, Takesumi; Shibata, Akira; Okamoto, Naoyuki; Shio, Hideo

    2013-01-01

    The Japan Collaborative Cohort Study for Evaluation of Cancer Risk (JACC Study) was established in the late 1980s to evaluate the risk impact of lifestyle factors and levels of serum components on human health. During the 20-year follow-up period, the results of the study have been published in almost 200 original articles in peer-reviewed English-language journals. However, continued follow-up of the study subjects became difficult because of the retirements of principal researchers, city mergers throughout Japan in the year 2000, and reduced funding. Thus, we decided to terminate the JACC Study follow-up at the end of 2009. As a final point of interest, we reviewed the population registry information of survivors. A total of 207 (0.19%) subjects were ineligible, leaving 110 585 eligible participants (46 395 men and 64 190 women). Moreover, errors in coding date of birth and sex were found in 356 (0.32%) and 59 (0.05%) cases, respectively, during routine follow-up and final review. Although such errors were unexpected, their impact is believed to be negligible because of the small numbers relative to the large total study population. Here, we describe the final cohort profile at the end of the JACC Study along with selected characteristics of the participants and their status at the final follow-up. Although follow-up of the JACC Study participants is finished, we will continue to analyze and publish study results.

  15. Reimbursement for Living Kidney Donor Follow-Up Care: How Often Does Donor Insurance Pay?

    Science.gov (United States)

    Kher, Ajay; Rodrigue, James; Ajaimy, Maria; Wasilewski, Marcy; Ladin, Keren; Mandelbrot, Didier

    2014-01-01

    Background Currently, many transplantation centers do not follow former living kidney donors on a long-term basis. Several potential barriers have been identified to provide this follow-up of former living kidney donors, including concerns that donor insurance will not reimburse transplantation centers or primary care physicians for this care. Here, we report the rates at which different insurance companies reimbursed our transplantation center for follow-up visits of living donors. Methods We collected data on all yearly follow-up visits of living donors billed from January 1, 2007, to December 31, 2010, representing 82 different donors. Concurrent visits of their recipients were available for 47 recipients and were used as a control group. Results We find that most bills for follow-up visits of living kidney donors were paid by insurance companies, at a rate similar to the reimbursement for recipient follow-up care. Conclusions Our findings suggest that, for former donors with insurance, inadequate reimbursement should not be a barrier in providing follow-up care. PMID:23060280

  16. Reimbursement for living kidney donor follow-up care: how often does donor insurance pay?

    Science.gov (United States)

    Kher, Ajay; Rodrigue, James; Ajaimy, Maria; Wasilewski, Marcy; Ladin, Keren; Mandelbrot, Didier

    2012-11-27

    Currently, many transplantation centers do not follow former living kidney donors on a long-term basis. Several potential barriers have been identified to provide this follow-up of former living kidney donors, including concerns that donor insurance will not reimburse transplantation centers or primary care physicians for this care. Here, we report the rates at which different insurance companies reimbursed our transplantation center for follow-up visits of living donors. We collected data on all yearly follow-up visits of living donors billed from January 1, 2007, to December 31, 2010, representing 82 different donors. Concurrent visits of their recipients were available for 47 recipients and were used as a control group. We find that most bills for follow-up visits of living kidney donors were paid by insurance companies, at a rate similar to the reimbursement for recipient follow-up care. Our findings suggest that, for former donors with insurance, inadequate reimbursement should not be a barrier in providing follow-up care.

  17. [Three-year follow-up of 12 patients with prostate cancer treated with monthly degarelix in a phase II clinical trial].

    Science.gov (United States)

    Hoshi, Senji; Hayashi, Natsuho; Yagi, Mayu; Ookubo, Teppei; Muto, Akinori; Sugano, Osamu; Numahata, Kenji; Bilim, Vladimir; Hoshi, Kiyotugu; Sasagawa, Isoji

    2014-01-01

    The efficacy and safety of degarelix, a luteinizing hormone-releasing hormone(LH-RH)antagonist, in patients with prostate cancer(PCa)were evaluated in a phase II, open-label, multicenter clinical trial. In this trial, a total of 13 patients were accrued at the Yamagata Prefectural Central Hospital from 2007 to 2008. The median age was 80 years(range, 65-85 years), and clinical stages were T1c, T2, T3, and T4 in 1, 4, 6, and 2 patients, respectively. Nodal(N)status was N0 in 9 patients and N1 in 4 patients. Distant metastases were absent(M0)in 12 patients and present(M1b)in 1 patient. The median prostate- specific antigen(PSA)level was 29.1 ng/mL(range, 6.3-427 ng/mL). All but one patient, who died of an unrelated cause, received a monthly dose(80 or 160mg)of degarelix for 12 months and were followed-up for 3 years. The PSA level declined in all patients. One patient died of an unrelated cause during the phase II trial. After completion of the phase II trial, 5 patients were treated with combined and rogen blockade(CAB)(leuprolide plus anti-androgen therapy), 2 patients were treated with single-agent leuprolide, 2 patients received single-agent bicalutamide, and 1 patient was followed-up without additional treatment. Radical prostatectomy was performed in 2 patients. Among the 5 patients treated with CAB, 2 died of metastatic cancer. CAB was effective in suppressing PSA levels in 3 patients. In 1 patient with T3aN1M1b PCa, colon cancer with lung metastases was detected during the follow-up period. Treatment with chemotherapy for colon cancer was effective in suppressing PSA levels for 12 months. In 1 patient with cT3aN1M0 PCa, the PSA level declined to size of the prostate gland and metastatic lymph nodes was observed. This effect persisted for 3.5 years after the completion of the 12-month degarelix regimen, and no additional treatment was required.

  18. Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: 10-Year Follow-Up of a Randomized Controlled Trial.

    Science.gov (United States)

    Saito, Yoshihiko; Okada, Sadanori; Ogawa, Hisao; Soejima, Hirofumi; Sakuma, Mio; Nakayama, Masafumi; Doi, Naofumi; Jinnouchi, Hideaki; Waki, Masako; Masuda, Izuru; Morimoto, Takeshi

    2017-02-14

    The long-term efficacy and safety of low-dose aspirin for primary prevention of cardiovascular events in patients with type 2 diabetes mellitus are still inconclusive. The JPAD trial (Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes) was a randomized, open-label, standard care-controlled trial examining whether low-dose aspirin affected cardiovascular events in 2539 Japanese patients with type 2 diabetes mellitus and without preexisting cardiovascular disease. Patients were randomly allocated to receive aspirin (81 or 100 mg daily; aspirin group) or no aspirin (no-aspirin group) in the JPAD trial. After that trial ended in 2008, we followed up with the patients until 2015, with no attempt to change the previously assigned therapy. Primary end points were cardiovascular events, including sudden death, fatal or nonfatal coronary artery disease, fatal or nonfatal stroke, and peripheral vascular disease. For the safety analysis, hemorrhagic events, consisting of gastrointestinal bleeding, hemorrhagic stroke, and bleeding from any other sites, were also analyzed. The primary analysis was conducted for cardiovascular events among patients who retained their original allocation (a per-protocol cohort). Analyses on an intention-to-treat cohort were conducted for hemorrhagic events and statistical sensitivity. The median follow-up period was 10.3 years; 1621 patients (64%) were followed up throughout the study; and 2160 patients (85%) retained their original allocation. Low-dose aspirin did not reduce cardiovascular events in the per-protocol cohort (hazard ratio, 1.14; 95% confidence interval, 0.91-1.42). Multivariable Cox proportional hazard model adjusted for age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia showed similar results (hazard ratio, 1.04; 95% confidence interval, 0.83-1.30), with no heterogeneity of efficacy in subgroup analyses stratified by each of these factors (all interaction P>0

  19. 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

    Full Text Available UNLABELLED: 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. METHODS: 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. RESULTS: 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

  20. 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

  1. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial.

    Science.gov (United States)

    Prince, H Miles; Kim, Youn H; Horwitz, Steven M; Dummer, Reinhard; Scarisbrick, Julia; Quaglino, Pietro; Zinzani, Pier Luigi; Wolter, Pascal; Sanches, Jose A; Ortiz-Romero, Pablo L; Akilov, Oleg E; Geskin, Larisa; Trotman, Judith; Taylor, Kerry; Dalle, Stephane; Weichenthal, Michael; Walewski, Jan; Fisher, David; Dréno, Brigitte; Stadler, Rudolf; Feldman, Tatyana; Kuzel, Timothy M; Wang, Yinghui; Palanca-Wessels, Maria Corinna; Zagadailov, Erin; Trepicchio, William L; Zhang, Wenwen; Lin, Hui-Min; Liu, Yi; Huebner, Dirk; Little, Meredith; Whittaker, Sean; Duvic, Madeleine

    2017-08-05

    Cutaneous T-cell lymphomas are rare, generally incurable, and associated with reduced quality of life. Present systemic therapies rarely provide reliable and durable responses. We aimed to assess efficacy and safety of brentuximab vedotin versus conventional therapy for previously treated patients with CD30-positive cutaneous T-cell lymphomas. In this international, open-label, randomised, phase 3, multicentre trial, we enrolled adult patients with CD30-positive mycosis fungoides or primary cutaneous anaplastic large-cell lymphoma who had been previously treated. Patients were enrolled across 52 centres in 13 countries. Patients were randomly assigned (1:1) centrally by an interactive voice and web response system to receive intravenous brentuximab vedotin 1·8 mg/kg once every 3 weeks, for up to 16 3-week cycles, or physician's choice (oral methotrexate 5-50 mg once per week or oral bexarotene 300 mg/m(2) once per day) for up to 48 weeks. The primary endpoint was the proportion of patients in the intention-to-treat population achieving an objective global response lasting at least 4 months per independent review facility. Safety analyses were done in all patients who received at least one dose of study drug. This trial was registered with ClinicalTrials.gov, number NCT01578499. Between Aug 13, 2012, and July 31, 2015, 131 patients were enrolled and randomly assigned to a group (66 to brentuximab vedotin and 65 to physician's choice), with 128 analysed in the intention-to-treat population (64 in each group). At a median follow-up of 22·9 months (95% CI 18·4-26·1), the proportion of patients achieving an objective global response lasting at least 4 months was 56·3% (36 of 64 patients) with brentuximab vedotin versus 12·5% (eight of 64) with physician's choice, resulting in a between-group difference of 43·8% (95% CI 29·1-58·4; p<0·0001). Grade 3-4 adverse events were reported in 27 (41%) of 66 patients in the brentuximab vedotin group and 29 (47%) of 62

  2. [Impact of the instrumental vaginal delivery on pain perception at two months].

    Science.gov (United States)

    Weslinck, N; De Jonckheere, J; Storme, L; Logier, R; Appel, M; Thomas, D; Rakza, T

    2014-06-01

    Although instrumental vaginal delivery reduces the risk of neonatal mortality, it increases the risk of specific morbidity including prolonged neonatal discomfort. Previous studies suggest that neonatal exposure to acute pain could have long-term effects on the pain response later in life. The aim of the study was to investigate whether instrumental vaginal delivery may alter the response to a noxious stimulus at the age of two months. Newborn infants were enrolled in this prospective observational study after parental consent. A group of children born by instrumental vaginal delivery (group 2) were compared to matched controls born by vaginal delivery (group 1). Pain was assessed in each newborn infant between two and four hours after birth using the scale of pain and discomfort of the newborn baby (EDIN). These children were reassessed for pain response to immunizations (Infanrix(®) and Prevenar(®)) at two months of age using the DAN scale. Thirteen children were enrolled in this study, six in group 1 and seven in group 2. Gestational age, birth weight, Apgar score, and umbilical arterial blood were similar in both groups. The EDIN measured between H2 and H4 was significantly higher in group 2 (median, 4 [IQ, 3] versus 0 [3.25], Pdelivery causes discomfort after birth and increases the pain response to immunization at the age of two months. This study supports the hypothesis that instrumental vaginal delivery may alter pain perception later in life. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  3. Preparing for LSST with the LCOGT NEO Follow-up Network

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    Greenstreet, Sarah; Lister, Tim; Gomez, Edward

    2016-10-01

    The Las Cumbres Observatory Global Telescope Network (LCOGT) provides an ideal platform for follow-up and characterization of Solar System objects (e.g. asteroids, Kuiper Belt Objects, comets, Near-Earth Objects (NEOs)) and ultimately for the discovery of new objects. The LCOGT NEO Follow-up Network is using the LCOGT telescope network in addition to a web-based system developed to perform prioritized target selection, scheduling, and data reduction to confirm NEO candidates and characterize radar-targeted known NEOs.In order to determine how to maximize our NEO follow-up efforts, we must first define our goals for the LCOGT NEO Follow-up Network. This means answering the following questions. Should we follow-up all objects brighter than some magnitude limit? Should we only focus on the brightest objects or push to the limits of our capabilities by observing the faintest objects we think we can see and risk not finding the objects in our data? Do we (and how do we) prioritize objects somewhere in the middle of our observable magnitude range? If we want to push to faint objects, how do we minimize the amount of data in which the signal-to-noise ratio is too low to see the object? And how do we find a balance between performing follow-up and characterization observations?To help answer these questions, we have developed a LCOGT NEO Follow-up Network simulator that allows us to test our prioritization algorithms for target selection, confirm signal-to-noise predictions, and determine ideal block lengths and exposure times for observing NEO candidates. We will present our results from the simulator and progress on our NEO follow-up efforts.In the era of LSST, developing/utilizing infrastructure, such as the LCOGT NEO Follow-up Network and our web-based platform for selecting, scheduling, and reducing NEO observations, capable of handling the large number of detections expected to be produced on a daily basis by LSST will be critical to follow-up efforts. We hope our

  4. 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

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    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

  5. An open-label study of algorithm-based treatment versus treatment-as-usual for patients with schizophrenia

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    Hirano J

    2013-10-01

    Full Text Available Jinichi Hirano,1,2 Koichiro Watanabe,3 Takefumi Suzuki,1,4 Hiroyuki Uchida,1 Ryosuke Den,5 Taishiro Kishimoto,1 Takashi Nagasawa,5 Yusuke Tomita,4 Koichiro Hara,6 Hiromi Ochi,7 Yoshimi Kobayashi,1 Mutsuko Ishii,1 Akane Fujita,1 Yoshihiko Kanai,1 Megumi Goto,1 Hiromi Hayashi,1 Kanako Inamura,1 Fumiko Ooshima,1 Mariko Sumida,1 Tomoko Ozawa,1 Kayoko Sekigawa,1 Maki Nagaoka,1 Kae Yoshimura,1 Mika Konishi,1 Ataru Inagaki,1 Takuya Saito,8 Nobutaka Motohashi,9 Masaru Mimura,1 Yoshiro Okubo,8 Motoichiro Kato,11Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan; 2Ohizumi Hospital, Tokyo, Japan; 3Department of Psychiatry School of Medicine, Kyorin University, Tokyo, Japan; 4Inokashira Hospital, Tokyo, Japan; 5Komagino Hospital, Tokyo, Japan; 6Asai Hospital, Chiba, Japan; 7Kurumegaoka Hospital, Tokyo, Japan; 8Department of Psychiatry School of Medicine, Nippon Medical School, Tokyo, Japan; 9Department of Psychiatry, School of Medicine, University of Yamanashi, Yamanashi, JapanObjective: The use of an algorithm may facilitate measurement-based treatment and result in more rational therapy. We conducted a 1-year, open-label study to compare various outcomes of algorithm-based treatment (ALGO for schizophrenia versus treatment-as-usual (TAU, for which evidence has been very scarce.Methods: In ALGO, patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, fourth edition were treated with an algorithm consisting of a series of antipsychotic monotherapies that was guided by the total scores in the positive and negative syndrome scale (PANSS. When posttreatment PANSS total scores were above 70% of those at baseline in the first and second stages, or above 80% in the 3rd stage, patients proceeded to the next treatment stage with different antipsychotics. In contrast, TAU represented the best clinical judgment by treating psychiatrists.Results: Forty-two patients (21 females, 39.0 ± 10.9 years

  6. Open-label atomoxetine for attention-deficit/ hyperactivity disorder symptoms associated with high-functioning pervasive developmental disorders.

    Science.gov (United States)

    Posey, David J; Wiegand, Ryan E; Wilkerson, Jennifer; Maynard, Melissa; Stigler, Kimberly A; McDougle, Christopher J

    2006-10-01

    The aim of this study was to conduct an initial evaluation of the efficacy of atomoxetine for attention-deficit/hyperactivity disorder (ADHD) symptoms in children with pervasive developmental disorders (PDDs). Children with PDDs and a nonverbal IQ of >or=70 received atomoxetine (target dose 1.2-1.4 mg/kg/day) during the course of an 8-week, open-label, prospective study. Standardized assessments of efficacy and tolerability were collected at regular intervals during the trial. Sixteen children and adolescents (mean age 7.7 +/- 2.2 years, age range 6-14 years) with autistic disorder (n = 7), Asperger's disorder (n = 7), or PDD not otherwise specified (n = 2) received atomoxetine (mean dose 1.2 +/- 0.3 mg/kg/day). Twelve participants (75%) were rated as "much" or "very much improved" on the Clinical Global Impressions-Improvement scale. The most significant improvement was seen in the area of ADHD symptoms as measured by the SNAP-IV and Aberrant Behavior Checklist (effect size = 1.0-1.9). Improvements of lesser magnitude (effect size = 0.4-1.1) were seen in irritability, social withdrawal, stereotypy, and repetitive speech. There were no significant changes on the Conners' Continuous Performance Test. Atomoxetine was well tolerated with the exception of 2 participants (13 %) who stopped medication due to irritability. Weight decreased by a mean of 0.8 kg during the 8-week trial. Placebo-controlled studies are indicated to determine atomoxetine's efficacy for ADHD symptoms in PDDs.

  7. Single-center open-label randomized study of anemia management improvement in ESRD patients with secondary hyperparathyroidism

    Directory of Open Access Journals (Sweden)

    Bellasi Antonio

    2016-04-01

    Full Text Available Whether anemia and mineral bone abnormalities (chronic kidney disease–mineral bone disorder [CKD-MBD] are associated still remains to be elucidated. Both anemia and CKD-MBD have been associated with adverse cardiovascular outcome and poor quality of life. However, recent evidence suggests that use of large doses of erythropoietin-stimulating agents (ESAs to correct hemoglobin (Hb may be detrimental in CKD. The Optimal Anemia Treatment in End Stage Renal Disease (ESRD (Optimal ESRD Treatment study will assess whether lowering of parathyroid hormone (PTH is associated with a reduction in ESA consumption. The Optimal ESRD Treatment study is a pilot single-center open-label study with blinded end point (a prospective randomized open blinded end-point [PROBE] design enrolling 50 patients on maintenance dialysis. Eligible patients with intact PTH (iPTH 300-540 pg/mL and Hb 10-11.5 g/dL will be randomized 1:1 to strict PTH control (150-300 pg/mL versus standard care (PTH range 300-540 pg/mL. Available drugs for CKD-MBD and anemia treatment will be managed by the attending physician to maintain the desired levels of PTH (according to study arm allocation and Hb (10-11.5 g/dL. Echocardiographic data for cardiac structure and function as well as arterial stiffness will be assessed at study inception and completion. The Optimal ESRD Treatment study should shed light on the complicated interplay of anemia and CKD-MBD and on the feasibility of clinical trials in this domain. The study results are expected in the spring of 2017.

  8. Gatifloxacin versus ofloxacin for the treatment of uncomplicated enteric fever in Nepal: an open-label, randomized, controlled trial.

    Directory of Open Access Journals (Sweden)

    Samir Koirala

    Full Text Available BACKGROUND: Fluoroquinolones are the most commonly used group of antimicrobials for the treatment of enteric fever, but no direct comparison between two fluoroquinolones has been performed in a large randomised trial. An open-label randomized trial was conducted to investigate whether gatifloxacin is more effective than ofloxacin in the treatment of uncomplicated enteric fever caused by nalidixic acid-resistant Salmonella enterica serovars Typhi and Paratyphi A. METHODOLOGY AND PRINCIPAL FINDINGS: Adults and children clinically diagnosed with uncomplicated enteric fever were enrolled in the study to receive gatifloxacin (10 mg/kg/day in a single dose or ofloxacin (20 mg/kg/day in two divided doses for 7 days. Patients were followed for six months. The primary outcome was treatment failure in patients infected with nalidixic acid resistant isolates. 627 patients with a median age of 17 (IQR 9-23 years were randomised. Of the 218 patients with culture confirmed enteric fever, 170 patients were infected with nalidixic acid-resistant isolates. In the ofloxacin group, 6 out of 83 patients had treatment failure compared to 5 out of 87 in the gatifloxacin group (hazard ratio [HR] of time to failure 0.81, 95% CI 0.25 to 2.65, p = 0.73. The median time to fever clearance was 4.70 days (IQR 2.98-5.90 in the ofloxacin group versus 3.31 days (IQR 2.29-4.75 in the gatifloxacin group (HR = 1.59, 95% CI 1.16 to 2.18, p = 0.004. The results in all blood culture-confirmed patients and all randomized patients were comparable. CONCLUSION: Gatifloxacin was not superior to ofloxacin in preventing failure, but use of gatifloxacin did result in more prompt fever clearance time compared to ofloxacin. TRIAL REGISTRATION: ISRCTN 63006567 (www.controlled-trials.com.

  9. Combined gemcitabine and S-1 chemotherapy for treating unresectable hilar cholangiocarcinoma: a randomized open-label clinical trial.

    Science.gov (United States)

    Li, Hao; Zhang, Zheng-Yun; Zhou, Zun-Qiang; Guan, Jiao; Tong, Da-Nian; Zhou, Guang-Wen

    2016-05-03

    Although the combination of cisplatin and gemcitabine (GEM) is considered the standard first-line chemotherapy against unresectable hilar cholangiocarcinoma (HC), its efficacy is discouraging. The present randomized open-label clinical trial aimed to evaluate the efficacy and safety of the GEM plus S-1 (GEM-S-1) combination against unresectable HC. Twenty-five patients per group were randomly assigned to receive GEM, S-1 or GEM-S-1. Neutropenia (56%) and leukopenia (40%) were the most common chemotherapy-related toxicities in the GEM-S-1 group. Median overall survival (OS) in the GEM-S-1, GEM and S-1 groups was 11, 10 and 6 months, respectively. GEM plus S-1 significantly improved OS compared to S-1 monotherapy (OR=0.68; 95%CI, 0.50-0.90; P=0.008). Median progression-free survival (PFS) times in the GEM-S-1, GEM and S-1 groups were 4.90, 3.70 and 1.60 months, respectively. GEM plus S-1 significantly improved PFS compared to S-1 monotherapy (OR=0.50; 95%CI, 0.27-0.91; P=0.024). Response rates were 36%, 24% and 8% in the GEM-S-1, GEM and S-1 groups, respectively. A statistically significant difference was found in response rates between the gemcitabine-S-1 and S-1 groups (36% vs 8%, P=0.017). Patients with CA19-9S-1 provides a better OS, PFS and response rate than S-1 monotherapy, but it did not significantly differ from GEM monotherapy. (ChiCTR-TRC-14004733).

  10. An open-label study of anidulafungin for the treatment of candidaemia/invasive candidiasis in Latin America.

    Science.gov (United States)

    Nucci, Marcio; Colombo, Arnaldo L; Petti, Marco; Magana, Martin; Abreu, Paula; Schlamm, Haran T; Sanchez, Sonia P

    2014-01-01

    Incidence and mortality of candidaemia/invasive candidiasis (C/IC) is relatively high in Latin America versus North America and Europe. To assess efficacy and safety of intravenous (IV) anidulafungin in Latin American adults with documented C/IC. All patients in this open-label study received initial IV anidulafungin with optional step-down to oral voriconazole after 5 days; total treatment duration was 14-42 days. The primary endpoint was global response (clinical + microbiological response) at end of treatment (EOT); missing/indeterminate responses were failures. The study enrolled 54 patients; 44 had confirmed C/IC within 96 h before study entry and comprised the modified intent-to-treat population. Global response at EOT was 59.1% (95% CI: 44.6, 73.6), with 13 missing/indeterminate assessments. Thirty-day all-cause mortality was 43.1%. Fourteen patients (31.8%) were able to step-down to oral voriconazole; these patients had lower baseline acute physiological assessment and chronic health evaluation (APACHE) II scores and were less likely to have solid tumours or previous abdominal surgery. Anidulafungin was generally well tolerated with few treatment-related adverse events. Anidulafungin was associated with relatively low response rates influenced by a high rate of missing/indeterminate assessments and mortality comparable to other recent candidaemia studies in Latin America. In a subset of patients with lower APACHE II scores, short-course anidulafungin followed by oral voriconazole was successful.

  11. Effects of quetiapine and olanzapine in patients with psychosis and violent behavior: a pilot randomized, open-label, comparative study

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    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

  12. Antithrombotic properties of rafigrelide: a phase 1, open-label, non-randomised, single-sequence, crossover study.

    Science.gov (United States)

    Balasubramaniam, K; Viswanathan, G; Dragone, J; Grose-Hodge, R; Martin, P; Troy, S; Preston, P; Zaman, A G

    2014-07-03

    Platelets play a central role in atherothrombotic events. We investigated the effect of a novel platelet-lowering agent, rafigrelide, on thrombus formation and characteristics. In this phase 1, open-label, non-randomised, single-sequence, crossover study, healthy male volunteers received rafigrelide for 14 days (Period 1). Following a ≥6-week washout period, they then received rafigrelide + acetylsalicylic acid (ASA) for 14 days (Period 2). Thrombus formation was assessed ex vivo using the Badimon perfusion chamber, and thrombus characteristics were assessed using thromboelastography. A total of 15 volunteers were enrolled in the study and were assigned to Panel A or Panel B, which had different schedules of assessments. In Panel A, after treatment with rafigrelide alone (Period 1), mean (± standard deviation) platelet count was reduced from 283 (± 17) × 10⁹/l at Day 1, to 125 (± 47) × 10⁹/l at Day 14 (n=6) and thrombus area reduced under high and low shear conditions. Reductions in thrombus area under high shear conditions correlated with reductions in platelet count (r²=0.11, p=0.022; n=12). Rafigrelide treatment prolonged clot formation time and reduced clot strength. The addition of ASA to rafigrelide (Period 2) had no additional effect on platelet count or thrombus area under high or low shear conditions. Similar results were seen in Panel B for all parameters. The most common adverse events (≥3 participants per period) were thrombocytopenia and headache. While confirming the platelet-lowering effects of rafigrelide, this early phase study also indicates that rafigrelide has antithrombotic properties under both high and low shear conditions.

  13. A phase 1/2, open-label study evaluating twice-daily administration of momelotinib in myelofibrosis

    Science.gov (United States)

    Gupta, Vikas; Mesa, Ruben A.; Deininger, Michael W.N.; Rivera, Candido E.; Sirhan, Shireen; Brachmann, Carrie Baker; Collins, Helen; Kawashima, Jun; Xin, Yan; Verstovsek, Srdan

    2017-01-01

    Momelotinib, a small-molecule inhibitor of Janus kinase 1 and Janus kinase 2, has demonstrated efficacy in myelofibrosis patients with 300 mg, once-daily dosing. This open-label, non-randomized, phase 1/2 study evaluated the safety and therapeutic benefit of momelotinib with twice-daily dosing. A total of 61 subjects with primary myelofibrosis or post–polycythemia vera/post–essential thrombocythemia myelofibrosis with intermediate- or high-risk disease received momelotinib. A phase 1 dose escalation identified 200 mg twice daily as the optimal dose to be expanded in phase 2. The most frequent adverse events were diarrhea (45.9%), peripheral neuropathy (44.3%), thrombocytopenia (39.3%), and dizziness (36.1%), the latter primarily due to a first-dose effect. The response assessment according to the 2006 International Working Group criteria (≥8 weeks duration at any time point) demonstrated spleen response by palpation of 72% (36/50) and anemia response of 45% (18/40). Spleen response by magnetic resonance imaging obtained at 24 weeks was 45.8% (27/59) for all subjects and 54.0% (27/50) for those with palpable splenomegaly at baseline. The symptoms of myelofibrosis were improved in most subjects. Cytokine analysis showed a rapid decline in interleukin-6 with momelotinib treatment, and a slower reduction in other inflammatory cytokines. In the subgroup of subjects with the JAK2V617F mutation at baseline (n=41), momelotinib significantly reduced the allele burden by 21.1% (median) at 24 weeks. These results provide evidence of tolerability and a potential therapeutic activity of momelotinib for subjects that support further evaluation in ongoing, phase 3 randomized trials. (clinicaltrials. gov identifier:01423058). PMID:27634203

  14. Sertraline and rapid eye movement sleep without atonia: an 8-week, open-label study of depressed patients.

    Science.gov (United States)

    Zhang, Bin; Hao, Yanli; Jia, Fujun; Tang, Yi; Li, Xueli; Liu, Wuhan; Arnulf, Isabelle

    2013-12-02

    Previous studies have reported that selective serotonin reuptake inhibitors (SSRIs) may induce or exacerbate rapid eye movement (REM) sleep without atonia (RSWA) and increase the risk of developing REM sleep behavior disorder (RBD). However, most of these studies are retrospective and cross-sectional and employed small sample sizes and a mixture of SSRIs. In this 8-week open-label trial of sertraline in depressed patients (n = 31), depressed patients were administered 50mg sertraline at 8 am on the 1st day and subsequently titrated up to a maximum of 200mg/day. All patients underwent repeated video-polysomnography (vPSG) (baseline, 1st day, 14th day, 28th day, and 56th day). Both tonic (submental) and phasic (submental and anterior tibialis) RSWA events were visually counted. Tonic RSWA increased from 3.2 ± 1.8% at baseline to 5.1 ± 2.3% on the 1st day and 10.4 ± 2.7% on the 14th day; after that, measurements were stable until the 56th day. A similar profile was observed for phasic RSWA. The increases in tonic RSWA (r = 0.56, P = 0.004) and phasic RSWA (submental: r = -0.51, P = 0.02; anterior tibialis: r = 0.41, P = 0.04) were correlated with the degree of the prolonging of REM latency. All of RSWAs were not correlated with patients' demographic and clinical characteristics. Sertraline may induce or exacerbate RSWA. In contrast to idiopathic RBD, sertraline-related RSWA had the specific characteristics of being correlated with the degree of the prolonging of REM latency and no predominance of male sex and elder age, suggesting different pathophysiological mechanisms. The antidepressant-related RSWA should be a potential public health problem in the depressed patients.

  15. Phase 1, open-label study of MEDI-547 in patients with relapsed or refractory solid tumors.

    Science.gov (United States)

    Annunziata, Christina M; Kohn, Elise C; LoRusso, Patricia; Houston, Nicole D; Coleman, Robert L; Buzoianu, Manuela; Robbie, Gabriel; Lechleider, Robert

    2013-02-01

    Targeting the cell-surface receptor EphA2, which is highly expressed in some solid tumors, is a novel approach for cancer therapy. We aimed to evaluate the safety profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of MEDI-547, an antibody drug conjugate composed of the cytotoxic drug auristatin (toxin) linked to a human anti-EphA2 monoclonal antibody (1C1), in patients with solid tumors relapsed/refractory to standard therapy. In this phase 1, open-label study with planned dose-escalation and dose-expansion cohorts, patients received a 1-h intravenous infusion of MEDI-547 (0.08 mg/kg) every 3 weeks. Six patients received 0.08 mg/kg; all discontinued treatment. Dose escalation was not pursued. The study was stopped before cohort 2 enrollment due to treatment-related bleeding and coagulation events (hemorrhage-related, n = 3; epistaxis, n = 2). Therefore, lower doses were not explored and an MTD could not be selected. The most frequently reported treatment-related adverse events (AEs) were increased liver enzymes, decreased hemoglobin, decreased appetite, and epistaxis. Three patients (50%) experienced treatment-related serious AEs, including conjunctival hemorrhage, pain (led to study drug discontinuation), liver disorder, and hemorrhage. Best response included progressive disease (n = 5; 83.3%) and stable disease (n = 1; 16.7%). Minimal or no dissociation of toxin from 1C1 conjugate occurred in the blood. Serum MEDI-547 concentrations decreased rapidly, ~70% by 3 days post-dose. No accumulation of MEDI-547 was observed at 0.08 mg/kg upon administration of a second dose 3 weeks following dose 1. The safety profile of MEDI-547 does not support further clinical investigation in patients with advanced solid tumors.

  16. Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study.

    Science.gov (United States)

    Caplin, Martyn E; Pavel, Marianne; Ćwikła, Jarosław B; Phan, Alexandria T; Raderer, Markus; Sedláčková, Eva; Cadiot, Guillaume; Wolin, Edward M; Capdevila, Jaume; Wall, Lucy; Rindi, Guido; Langley, Alison; Martinez, Séverine; Gomez-Panzani, Edda; Ruszniewski, Philippe

    2016-03-01

    In the CLARINET study, lanreotide Autogel (depot in USA) significantly prolonged progression-free survival (PFS) in patients with metastatic pancreatic/intestinal neuroendocrine tumours (NETs). We report long-term safety and additional efficacy data from the open-label extension (OLE). Patients with metastatic grade 1/2 (Ki-67 ≤ 10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until death/progressive disease (PD) in CLARINET study. Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE. In total, 88 patients (previously: lanreotide, n = 41; placebo, n = 47) participated: 38% had pancreatic, 39% midgut and 23% other/unknown primary tumours. Patients continuing lanreotide reported fewer adverse events (AEs) (all and treatment-related) during OLE than core study. Placebo-to-lanreotide switch patients reported similar AE rates in OLE and core studies, except more diarrhoea was considered treatment-related in OLE (overall diarrhoea unchanged). Median lanreotide PFS (core study randomisation to PD in core/OLE; n=101) was 32.8 months (95% CI: 30.9, 68.0). A sensitivity analysis, addressing potential selection bias by assuming that patients with SD on lanreotide in the core study and not entering the OLE (n=13) had PD 24 weeks after last core assessment, found median PFS remaining consistent: 30.8 months (95% CI: 30.0, 31.3). Median time to further PD after placebo-to-lanreotide switch (n=32) was 14.0 months (10.1; not reached). This OLE study suggests long-term treatment with lanreotide Autogel 120 mg maintained favourable safety/tolerability. CLARINET OLE data also provide new evidence of lanreotide anti-tumour benefits in indolent and progressive pancreatic/intestinal NETs. © 2016 The authors.

  17. Preliminary open-label clinical evaluation of the soothing and reepithelialization properties of a novel topical formulation for rosacea

    Directory of Open Access Journals (Sweden)

    Sparavigna A

    2014-10-01

    Full Text Available Adele Sparavigna, Beatrice Tenconi, Ileana De Ponti Derming Srl, Monza, Italy Background: Rosacea is a common, incurable skin barrier disorder characterized by relapses and remissions. Purpose: To evaluate the efficacy of Farmaka Rosacea Cream (FRC, a novel topical formulation for rosacea. Methods: This single-center, open-label pilot study comprised a single-dose substudy in 20 healthy subjects and a long-term, repeat-dose substudy in 22 subjects with rosacea. The 2-hour, controlled, single-dose substudy assessed the soothing and reepithelialization properties of FRC after stripping-induced erythema based on the erythema index, transepidermal water loss, skin hydration, and clinical assessments of erythema. In the long-term substudy, subjects applied FRC twice daily for 8 weeks. Clinical assessments included vascular and pigmentary homogeneity and erythema and hemoglobin indices. Subjects completed questionnaires to assess FRC efficacy and cosmetic acceptability. Results: Greater reductions were seen in FRC-treated areas compared with untreated areas for the erythema index (-16% versus -8%; P<0.001 and mean transepidermal water loss (-35.8% versus -10.1%; P<0.001 30 minutes after stripping. Significant improvements over untreated areas were maintained 2 hours after stripping. Skin hydration and clinical erythema assessments also indicated that FRC soothed rosacea symptoms and promoted skin reepithelialization. Erythema and hemoglobin indices were significantly reduced from baseline after 4 and 8 weeks of treatment. Clinically assessed parameters were significantly improved following FRC application. Subjects assessed FRC positively. Conclusion: Improvement of rosacea symptoms was noted with FRC application. The main film-forming ingredients of FRC (trehalose, cholesterol, ceramide, and fatty acids, combined with other soothing and calming ingredients and ultraviolet filters, could explain its efficacy. Keywords: rosacea, erythema, skin

  18. Options for early breast cancer follow-up in primary and secondary care - a systematic review

    Directory of Open Access Journals (Sweden)

    Taggart Frances

    2012-06-01

    Full Text Available Abstract Background Both incidence of breast cancer and survival have increased in recent years and there is a need to review follow up strategies. This study aims to assess the evidence for benefits of follow-up in different settings for women who have had treatment for early breast cancer. Method A systematic review to identify key criteria for follow up and then address research questions. Key criteria were: 1 Risk of second breast cancer over time - incidence compared to general population. 2 Incidence and method of detection of local recurrence and second ipsi and contra-lateral breast cancer. 3 Level 1–4 evidence of the benefits of hospital or alternative setting follow-up for survival and well-being. Data sources to identify criteria were MEDLINE, EMBASE, AMED, CINAHL, PSYCHINFO, ZETOC, Health Management Information Consortium, Science Direct. For the systematic review to address research questions searches were performed using MEDLINE (2011. Studies included were population studies using cancer registry data for incidence of new cancers, cohort studies with long term follow up for recurrence and detection of new primaries and RCTs not restricted to special populations for trials of alternative follow up and lifestyle interventions. Results Women who have had breast cancer have an increased risk of a second primary breast cancer for at least 20 years compared to the general population. Mammographically detected local recurrences or those detected by women themselves gave better survival than those detected by clinical examination. Follow up in alternative settings to the specialist clinic is acceptable to women but trials are underpowered for survival. Conclusions Long term support, surveillance mammography and fast access to medical treatment at point of need may be better than hospital based surveillance limited to five years but further large, randomised controlled trials are needed.

  19. The meaning of follow-up in intensive care: patients' perspective.

    Science.gov (United States)

    Storli, Sissel L; Lind, Ranveig

    2009-03-01

    The growing understanding of correlations between experiences and memories from a period of intensive care treatment and complaints of mental character has led to the development of various patient follow-up offers. Little, however, is known about what follow-up may mean to patients. The aim of this study was to explore the meaning of patients' lived experience of being followed-up in a programme consisting of patient diaries, post-intensive care unit (ICU) conversations and visits back to the ICU. Field notes were made from encounters with patients (n = 10) during follow-up. Then they were interviewed twice, at about 6 months (n = 8) and at about 18 months (n = 6) after discharge from hospital. The first interview focused on the patients' experience during intensive care and on their reflections on the experience. The second interview had a particular focus on the meaning for each individual of the sources for understanding that they had been offered. The data was analysed by using a hermeneutic-phenomenological approach. The study corroborated earlier research that found that patients seek to understand experiences they have undergone. They search for meaning in experiences and memories. It is realized that the diary as text and photos, in addition to conveying care and love, is important to induce postexperience reflections. It provided guideposts that follow-up conversations could pursue in the patient's quest for meaning. The conversation also provided an opening for, and could in itself be essential to, the patient's willingness to talk about experiences. It allowed the nurse to accompany the patient in his quest for meaning. The return visit appeared to be significant in the patient's quest for meaning. It was via 'feeling' the room that 'things' fell into place. The study is important in elucidating aspects that are beneficial in the patient's follow-up and which lay the basis for further development of existing and new follow-up offers.

  20. Automated telecommunication to obtain longitudinal follow-up in a multicenter cross-sectional COPD study.

    Science.gov (United States)

    Stewart, Jeffrey I; Moyle, Sarah; Criner, Gerard J; Wilson, Carla; Tanner, Ron; Bowler, Russell P; Crapo, James D; Zeldin, Robert K; Make, Barry J; Regan, Elizabeth A; For The Copdgene Investigators

    2012-08-01

    It can be challenging to maintain longitudinal follow-up of subjects in clinical studies. COPDGene is a multicenter, observational study designed to identify genetic factors associated with COPD and to characterize COPD-related phenotypes. To obtain follow-up data on patient's vital status and outcomes, the COPDGene Longitudinal Follow-up (LFU) Program was developed to supplement its parent study. We used a telecommunication system that employed automated telephone contact or web-based questions to obtain longitudinal follow-up data in our subjects. A branching questionnaire asked about exacerbations, new therapies, smoking status, development of co-morbid conditions, and general health status. Study coordinators contacted subjects who did not respond to one of the automated methods. We enrolled 10,383 subjects in the COPDGene study. As of August 29, 2011, 7,959 subjects completed 19,955 surveys. On the first survey, 68.8% of subjects who completed their survey did so by electronic means, while 31.3% required coordinator phone follow-up. On each subsequent survey the number of subjects who completed their survey by electronic means increased, while the number of subjects who required coordinator follow-up decreased. Despite many of the patients in the cohort being chronically ill and elderly, there was broad acceptance of the system with over half the cohort using electronic response methods. The COPDGene LFU Study demonstrated that telecommunications was an effective way to obtain longitudinal follow-up of subjects in a large multicenter study. Web-based and automated phone contacts are accepted by research subjects and could serve as a model for LFU in future studies.

  1. Does routine ultrasound change management in the follow-up of patients with vesicoureteral reflux?

    Science.gov (United States)

    Rudzinski, Jan K; Weber, Bryce; Wildgoose, Petra; Lorenzo, Armando; Bagli, Darius; Farhat, Walid; Harvey, Elizabeth; Salle, Joao Luiz Pippi

    2013-01-01

    Children with vesicoureteral reflux (VUR) usually need a renal ultrasound (RUS). There is little data on the role of follow-up RUS in VUR. We evaluated the impact of follow-up RUS on the change in clinical management in patients with VUR. We prospectively analyzed children with a previous diagnosis of VUR seen in the outpatient clinic with a routine follow-up RUS within 4 months. Variables collected included: demographic data, VUR history, dysfunctional voiding symptoms and concurrent ultrasound findings. Change in management was defined as addition of new medication, nurse counselling, surgery or further investigations. The study included 114 consecutive patients. The mean patient age was 4.5 years old, mean age of VUR diagnosis was 1.7 years, with average follow-up of 2.8 years. A change in management with stable RUS occurred in 14 patients, in which the change included ordering a DMSA in 9, nurse counselling for dysfunctional voiding in 3, and booking surgery in 2 patients. Change on RUS was seen in 4 patients. Multivariable analysis showed that history of urinary tract infection (UTI) since the last follow-up visit was more significant than RUS findings. The RUS findings in most patients followed for VUR remain stable or with minimal changes. The variable showing a significant effect on change in management in our study was history of UTI since the last follow-up visit rather than RUS findings. The value of follow-up RUS for children with VUR may need to be revisited.

  2. 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

  3. 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.

  4. Alternatives to ultrasound for follow-up after medication abortion: a systematic review.

    Science.gov (United States)

    Grossman, Daniel; Grindlay, Kate

    2011-06-01

    Requiring a follow-up visit with ultrasound evaluation to confirm completion after medication abortion can be a barrier to providing the service. The PubMed (including MEDLINE), Cochrane Central Register of Controlled Trials and POPLINE databases were systematically searched in October and November 2009 for studies related to alternative follow-up modalities after first-trimester medication abortion to diagnose ongoing pregnancy or retained gestational sac. We calculated the sensitivity, specificity, positive predictive value and negative predictive value compared with ultrasound or clinician's exam. We also calculated the proportion of cases in each study with a positive screening test. Our search identified eight articles. The most promising modalities included serum human chorionic gonadotropin measurements, standardized assessment of women's symptoms combined with low-sensitivity urine pregnancy testing and telephone consultation. These follow-up modalities had sensitivities ≥90%, negative predictive values ≥99% and proportions of "screen-positives" ≤33%. Alternatives to routine in-person follow-up visits after medication abortion are accurate at diagnosing ongoing pregnancy. Additional research is needed to demonstrate the accuracy, acceptability and feasibility of alternative follow-up modalities in practice, particularly of home-based urine testing combined with self-assessment and/or clinician-assisted assessment. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. Patient attendance in a recall program after prosthodontic rehabilitation: a 5-year follow-up.

    Science.gov (United States)

    Wolfart, Stefan; Weyer, Nils; Kern, Matthias

    2012-01-01

    This study evaluated the recall attendance and maintenance for a patient population after prosthodontic treatment in undergraduate student courses. Four hundred ninety-three patients who received fixed restorations (FRs; crowns or fixed partial dentures) or removable partial dentures (RPDs; conical crown-retained or precision attachment-retained dental prostheses) were included in a recall program. The number of patients attending regularly scheduled follow-up visits every 6 months was recorded. On the basis of the complexity of the performed treatment, all follow-up interventions were assigned to the categories minimal, moderate, or extensive. After 60 months, a cumulative follow-up attendance rate between 63% (RPD) and 74% (FR) was evident and not gender related. Altogether, 399 patients (193 FR, 206 RPD) regularly attended the follow-up visits. Between 61.9% (RPD) and 93.8% (FR) of these patients did not need any extensive treatment; however, only 19.2% (RPD) to 85.6% (FR) did not need any moderate or extensive treatment between follow-up visits. Patients treated with FRs showed a higher recall attendance than patients treated with RPDs. Further, patients with RPDs needed more extensive and moderate treatments than patients with FRs. This difference should be taken into consideration during prosthetic planning and patient consultation.

  6. Six-Year Experience of a Nurse-Led Colorectal Cancer Follow-Up Clinic

    Directory of Open Access Journals (Sweden)

    Hasan Al Chalabi

    2014-01-01

    Full Text Available Aims and Objectives. To review the experience of a nurse-led colorectal cancer follow-up clinic in a tertiary referral colorectal cancer centre. Methodology. Data from the nurse-led colorectal cancer follow-up clinic in our unit was prospectively maintained in a colorectal cancer database. Data was analysed from January 1, 2006 until the December 31, 2011. Results. 1125 patients were diagnosed with colorectal cancer, and referred to our unit as a tertiary centre for specialised colorectal cancer. Nine hundred and four patients had surgical resection of their colorectal cancer. Four hundred and seven patients were referred to the nurse-led colorectal cancer clinic for surveillance. The mean age of the patient cohort was 67 years (range 32–88 and 56% of patients were male. One hundred and seventeen patients were discharged to their general practitioner having been disease free after 5 years of followup. Fifty-four patients were diagnosed with either local or distant recurrence. Conclusion. A nurse-led colorectal cancer follow-up clinic is running according to strict follow-up protocols. This type of clinic significantly reduces the number of routine follow-up patients that have to be seen by the colorectal surgical consultant.

  7. Six-year experience of a nurse-led colorectal cancer follow-up clinic.

    Science.gov (United States)

    Al Chalabi, Hasan; O'Riordan, James M; Richardson, Alex; Flannery, Delia; O'Connor, Katrina; Stuart, Charlotte; Larkin, John; McCormick, Paul; Mehigan, Brian

    2014-01-01

    Aims and Objectives. To review the experience of a nurse-led colorectal cancer follow-up clinic in a tertiary referral colorectal cancer centre. Methodology. Data from the nurse-led colorectal cancer follow-up clinic in our unit was prospectively maintained in a colorectal cancer database. Data was analysed from January 1, 2006 until the December 31, 2011. Results. 1125 patients were diagnosed with colorectal cancer, and referred to our unit as a tertiary centre for specialised colorectal cancer. Nine hundred and four patients had surgical resection of their colorectal cancer. Four hundred and seven patients were referred to the nurse-led colorectal cancer clinic for surveillance. The mean age of the patient cohort was 67 years (range 32-88) and 56% of patients were male. One hundred and seventeen patients were discharged to their general practitioner having been disease free after 5 years of followup. Fifty-four patients were diagnosed with either local or distant recurrence. Conclusion. A nurse-led colorectal cancer follow-up clinic is running according to strict follow-up protocols. This type of clinic significantly reduces the number of routine follow-up patients that have to be seen by the colorectal surgical consultant.

  8. Long-Term Ultrasound Follow-Up of Thyroid Colloid Cysts

    Directory of Open Access Journals (Sweden)

    Dong Wook Kim

    2014-01-01

    Full Text Available Objective. This study aimed to assess the interval changes of thyroid colloid cysts (TCCs by performing long-term ultrasound (US follow-up examinations. Methods. From 2007 to 2008, 437 patients underwent a lobectomy for the treatment of papillary thyroid microcarcinoma. Among them, 268 patients underwent 4 or more postoperative US follow-ups after surgery. This study investigated the prevalence and interval changes of TCCs ≥3 mm by using US follow-ups. Results. Among 268 patients, 35 (13.1% had TCCs ≥3 mm by a preoperative thyroid US, and 6 (2.2% had newly detected TCCs at a US follow-up. Through long-term US follow-up, the interval changes for TCCs were classified as follows: no interval change (n=8, gradual increase (n=8, gradual decrease (n=5, positive fluctuation (n=3, negative fluctuation (n=6, disappearance (n=5, and new detection (n=6. None of the TCC cases had a TCC that was ≥10 mm at its largest diameter, and no patient complained of any relevant symptoms pertaining to the TCCs. Conclusions. In this study, TCCs demonstrated various interval changes, but no abrupt increase was found or acute onset of symptoms occurred.

  9. 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.)

  10. Cardiac surgery patients' evaluation of the quality of theatre nurse postoperative follow-up visit.

    Science.gov (United States)

    Falk-Brynhildsen, Karin; Nilsson, Ulrica

    2009-06-01

    Theatre nurses at the Department of Cardiothoracic Surgery in Orebro, Sweden, have since 2001 routinely conducted a follow-up visit to postoperative cardiac patients. A model with a standardized information part and an individual-caring conversation including both a retrospective and a prospective part designed the visit. The purpose of this study was to evaluate the quality of the postoperative follow-up visit conducted by the theatre nurses and find out if the quality was related to gender or type of admission. The method was prospective and explorative, including 74 cardiac surgery patients who had had a postoperative follow-up visit by a theatre nurse in Sweden. The instrument measuring quality, from the patient's perspective, measured the quality of the visit, and consisted of 16 items modified to suit the study. The results showed an overall high quality rating, with statistically significant higher scores for six items between patients who had undergone emergency surgery, in comparison with elective patients. When comparing gender, women had statistically significant higher scores in two items. In conclusion, this postoperative follow-up visit by the theatre nurse was a valuable and useful tool especially for the patients who had undergone emergency surgery. In the follow-up visit the theatre nurse creates a caring relationship by meeting the patient as an individual with his/her own experience and needs for information about the surgery, intra and postoperative care, and recovery.

  11. Efficacy and safety of long-acting pasireotide in Japanese patients with acromegaly or pituitary gigantism: results from a multicenter, open-label, randomized, phase 2 study.

    Science.gov (United States)

    Tahara, Shigeyuki; Murakami, Mami; Kaneko, Tomomi; Shimatsu, Akira

    2017-07-28

    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism. Medically naïve or inadequately controlled patients (on somatostatin analogues or dopamine agonists) were included. Primary end point was the proportion of all patients who achieved biochemical control (mean growth hormone [GH] levelsacromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg. The median age was 52 years (range, 31-79) and 20 patients were males. At month 3, 18.2% of patients (6/33; 90% confidence interval: 8.2%, 32.8%) had biochemical control (21.2% [7/33] when including a patient with mean GHacromegaly or pituitary gigantism.

  12. A Nutritional Formulation for Cognitive Performance in Mild Cognitive Impairment: A Placebo-Controlled Trial with an Open-Label Extension.

    Science.gov (United States)

    Remington, Ruth; Lortie, Jevin J; Hoffmann, Heather; Page, Robert; Morrell, Christopher; Shea, Thomas B

    2015-01-01

    Thirty-four individuals with mild cognitive impairment were randomized for 6 months to a nutraceutical formulation (NF: folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) or indistinguishable placebo, followed by a 6-month open-label extension in which all individuals received NF. The NF cohort improved in the Dementia Rating Scale (DRS; effect size >0.7) and maintained baseline performance in CLOX-1. The placebo cohort did not improve in DRS and declined in CLOX-1, but during the open-label extension improved in DRS and ceased declining in CLOX-1. These findings extend prior studies of NF efficacy for individuals without cognitive impairment and with Alzheimer's disease.

  13. Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results

    OpenAIRE

    Stengel, Fernando M; Petri, Valeria [UNIFESP; Campbell, Gladys AM; Dorantes, Gladys Leon; López, Magdalina; Ricardo L. Galimberti; Valdez, Raúl P; de Arruda, Lucia F; Guerra, Mario Amaya; Chouela, Edgardo N; Licu, Daiana; ,

    2009-01-01

    Introduction Psoriasis is a debilitating, chronic inflammatory systemic disease affecting around 2% of the South American population. Biological therapies offer the possibility of long-term therapy with improved safety and efficacy. Methods We conducted a multicentre, open-label, single-arm, Phase IIIb/IV study of adult patients (18–75 years) with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. Patients received efalizumab subcutaneously (1.0 mg/k...

  14. A Prospective, Open Label, Observational Study to Assess the Safety and Efficacy of Herbal Cough Syrup Mykoff® in Patients Suffering from Cough of Varied Aetiologies

    OpenAIRE

    Mangesh Bhalerao; Pradip Awale; Abhijeet Sawle; Dhananjay Sangle; Devendra B Sonawane; Vilas Chavan

    2013-01-01

    A prospective, open label, observational study was conducted at general outpatient clinic to assess the safety and efficacy of herbal cough syrup Mykoff® in patients suffering from cough of varied aetiologies. The patients of either sex, age > 3yrs, suffering from cough due to common cold, mild to moderate upper respiratory tract infections, allergic cough and smoker’s cough were enrolled. The safety was evaluated by means of an analysis of adverse events. In addition, efficacy and tolerabili...

  15. A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis pa