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  1. 18F-FDG-PET detects complete response to PD1-therapy in melanoma patients two weeks after therapy start

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    Seith, Ferdinand; Schmidt, Holger; Pfannenberg, Christina; Gueckel, Brigitte; Schwenzer, Nina [Eberhard Karls University, Diagnostic and Interventional Radiology, Department of Radiology, Tuebingen (Germany); Forschner, Andrea; Garbe, Claus [Eberhard Karls University, Department of Dermatology, Tuebingen (Germany); Nikolaou, Konstantin [Eberhard Karls University, Diagnostic and Interventional Radiology, Department of Radiology, Tuebingen (Germany); German Cancer Consortium (DKTK), Heidelberg (Germany); La Fougere, Christian [German Cancer Consortium (DKTK), Heidelberg (Germany); Eberhard Karls University, Nuclear Medicine and Clinical Molecular Imaging, Department of Radiology, Tuebingen (Germany)

    2018-01-15

    The aim of the study was to evaluate if 18F-FDG-PET has the potential to detect complete responders to PD1-therapy in patients with unresectable metastasized melanoma two weeks after therapy initiation. Between September 2014 and May 2016, ten patients (four females; 65 ± 12 y) received a whole-body 18F-FDG-PET/MRI examination at three time points: Before therapy start (t{sub 0}, base-line), two weeks (t{sub 1}, study examination) and three months after treatment initiation (t{sub 2}, reference standard). Therapy response was assessed with PET response criteria in solid tumors (PERCIST). Time to progression and overall survival (OS) were obtained for all patients. Three patients with partial metabolic response in PET at t{sub 1} turned out to have complete response at t{sub 2}. No tumor relapse was observed in those patients so far (observation period: 265, 511 and 728 days, respectively). At t{sub 2}, progressive metabolic disease (PMD) was seen in six patients from whom four showed PMD and two showed stable metabolic disease (SMD) at t{sub 1}. OS in patients with PMD at t{sub 2} varied between 148 and 814 days. SMD at both t{sub 1} and t{sub 2} was seen in one patient, tumor progress was observed after 308 days. Our study indicates that whole-body 18F-FDG-PET might be able to reliably identify complete responders to PD1-therapy as early as two weeks after therapy initiation in stage IV melanoma patients. This might help to shorten therapy regimes and avoid unnecessary side effects in the future. (orig.)

  2. Patterns of long-term and short-term responses in adult patients with attention-deficit/hyperactivity disorder in a completer cohort of 12 weeks or more with atomoxetine.

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    Sobanski, E; Leppämäki, S; Bushe, C; Berggren, L; Casillas, M; Deberdt, W

    2015-11-01

    Atomoxetine is a well-established pharmacotherapy for adult ADHD. Long-term studies show incremental reductions in symptoms over time. However, clinical experience suggests that patients differ in their response patterns. From 13 Eli Lilly-sponsored studies, we pooled and analyzed data for adults with ADHD who completed atomoxetine treatment at long-term (24 weeks; n=1443) and/or short-term (12 weeks; n=2830) time-points, and had CAARS-Inv:SV total and CGI-S data up to or after these time-points and at Week 0 (i.e. at baseline, when patients first received atomoxetine). The goal was to identify and describe distinct trajectories of response to atomoxetine using hierarchical clustering methods and linear mixed modelling. Based on the homogeneity of changes in CAARS-Inv:SV total scores, 5 response clusters were identified for patients who completed long-term (24 weeks) treatment with atomoxetine, and 4 clusters were identified for patients who completed short-term (12 weeks) treatment. Four of the 5 long-term clusters (comprising 95% of completer patients) showed positive trajectories: 2 faster responding clusters (L1 and L2), and 2 more gradually responding clusters (L3 and L4). Responses (i.e.≥30% reduction in CAARS-Inv:SV total score, and CGI-S score≤3) were observed at 8 and 24 weeks in 80% and 95% of completers in Cluster L1, versus 5% and 48% in Cluster L4. While many adults with ADHD responded relatively rapidly to atomoxetine, others responded more gradually without a clear plateau at 24 weeks. Longer-term treatment may be associated with greater numbers of responders. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  3. A recurrent ovarian cancer patient with a history of nine prior chemotherapy regimens who was safely treated with weekly paclitaxel plus bevacizumab and achieved a complete response: a case report

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    Takatori E

    2015-08-01

    Full Text Available Eriko Takatori,1 Tadahiro Shoji,1 Takayuki Nagasawa,1 Satoshi Takeuchi,1 Akira Hosoyachi,2 Toru Sugiyama1 1Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University, Morioka, Japan; 2Department of Obstetrics and Gynecology, Iwate Prefectural Miyako Hospital, Miyako, Japan Abstract: Herein, we describe our experience with a recurrent ovarian cancer patient who was treated safely with bevacizumab and who achieved a complete response despite receiving nine prior chemotherapy regimens. The patient was a 54-year-old woman with stage IIIC recurrent ovarian serous adenocarcinoma (grade 3. Computed tomography (CT revealed that no evidence of ascites, multiple intraperitoneal dissemination, or intrapelvic lymph node metastases was present. The absence of bowel obstruction and disseminated lesions involving the intestinal tract was confirmed by CT. Performance status was 0, and a blood test also indicated preservation of major organ function. In our hospital, weekly paclitaxel plus bevacizumab therapy (paclitaxel at 80 mg/m2 on days 1, 8, and 15; bevacizumab at 15/mg/kg on day 1 and every 21 days thereafter was started. Eight cycles were administered, with no signs of gastrointestinal perforation, and the antitumor effect was evaluated as a complete response. The observed adverse events included grade 1 hyponatremia and grade 1 hypochloremia, and there was one grade 1 sensory peripheral neuropathy. These adverse events neither delayed treatment nor necessitated any dosage reductions. This case suggests that bevacizumab can be safely administered even to patients with recurrent ovarian cancer who have received three or more prior chemotherapy regimens if there are neither symptoms of bowel obstruction nor lesions suggestive of intestinal invasion on diagnostic imaging. Keywords: recurrent ovarian cancer, gastrointestinal perforation 

  4. Patient satisfaction with clinicians in colorectal 2-week wait clinics.

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    Cock, Karen; Kent, Bridie

    2017-03-23

    To determine if patient satisfaction is affected by the clinician (nurse or doctor), conducting the colorectal 2-week wait (2ww) clinics. A prospective non-randomised comparative cohort study of 339 consecutive patients (divided by blind allocation into nurse-led (n=216) and doctor-led (n=123) cohorts) conducted over a 3-month period. Patient satisfaction in both cohorts was assessed by an adapted version of the Grogan et al validated patient satisfaction questionnaire. The questionnaire was piloted first and was found to have high internal reliability (Cronbach's alpha=0.91). The study had a response rate of 78% (n=258/331) and overall satisfaction scores showed 85% (n=149/175) of patients in the nurse-led cohort and 65% (n=54/83) of patients in the doctor-led cohort strongly agreed that they were satisfied with the care they received. Mean overall satisfaction scores in the two cohorts revealed that the nurse-led cohort achieved significantly more 'strongly agree' responses than the doctor-led cohort (ppatient satisfaction was affected by the clinician conducting the 2ww clinic, in that the nurse-led cohort displayed significantly higher patient satisfaction. However, there are areas that merit further research.

  5. Older patients can accurately recall their preoperative health status six weeks following total hip arthroplasty.

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    Marsh, Jackie; Bryant, Dianne; MacDonald, Steven J

    2009-12-01

    In clinical trials, use of patient recall data would be beneficial when the collection of baseline data is impossible, such as in trauma situations. We investigated the ability of older patients to accurately recall their preoperative quality of life, function, and general health status at six weeks following total hip arthroplasty. We randomized consecutive patients who were fifty-five years of age or older into two groups. At each assessment, patients completed self-report questionnaires (at four weeks preoperatively, on the day of surgery, and at six weeks and three months postoperatively for Group 1 and at six weeks and three months postoperatively for Group 2). At six weeks postoperatively, all patients completed the questionnaires on the basis of their recollection of their preoperative health status. We evaluated the validity and reliability of recall ratings, the degree of error in recall ratings, and the effects of the use of recall data on power and sample size requirements. A total of 174 patients (mean age, seventy-one years) who were undergoing either primary or revision total hip arthroplasty were randomized and included in the analysis (118 patients were in Group 1 and fifty-six were in Group 2). Agreement between actual and recalled data was excellent for disease-specific questionnaires (intraclass correlation coefficient, 0.86, 0.87, and 0.88) and moderate for generic health measures (intraclass correlation coefficient, 0.48, 0.58, and 0.60). Increased error associated with recalled ratings compared with actual ratings necessitates minimal increases in sample size or results in small decreases in power. Patients undergoing total hip arthroplasty can accurately recall their preoperative health status at six weeks postoperatively.

  6. Providing a complete online multimedia patient record.

    Science.gov (United States)

    Dayhoff, R. E.; Kuzmak, P. M.; Kirin, G.; Frank, S.

    1999-01-01

    Seamless integration of all types of patient data is a critical feature for clinical workstation software. The Dept. of Veterans Affairs has developed a multimedia online patient record that includes traditional medical chart information as well as a wide variety of medical images from specialties such as cardiology, pulmonary and gastrointestinal medicine, pathology, radiology, hematology, and nuclear medicine. This online patient record can present data in ways not possible with a paper chart or other physical media. Obtaining a critical mass of information online is essential to achieve the maximum benefits from an integrated patient record system. Images Figure 1 Figure 2 PMID:10566357

  7. Advanced non-small cell lung cancer in elderly patients: The standard every 3-weeks versus weekly paclitaxel with carboplatin

    Directory of Open Access Journals (Sweden)

    Hala Mohamed El-Shenshawy

    2012-10-01

    Conclusions: Efficacy was similar between the weekly regimen and the standard regimen of carboplatin and paclitaxel for elderly patients with advanced NSCLC and may be advantageous based on its favorable tolerability profile.

  8. A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer

    International Nuclear Information System (INIS)

    Geara, Fady B; Shamseddine, Ali; Khalil, Ali; Abboud, Mirna; Charafeddine, Maya; Seoud, Muhieddine

    2010-01-01

    This is a prospective comparison of weekly cisplatin to weekly paclitaxel as concurrent chemotherapy with standard radiotherapy for locally advanced cervical carcinoma. Between May 2000 and May 2004, 31 women with FIGO stage IB2-IVA cervical cancer or with postsurgical pelvic recurrence were enrolled into this phase II study and randomized to receive on a weekly basis either 40 mg/m 2 Cisplatin (group I; 16 patients) or 50 mg/m 2 paclitaxel (group II; 15 patients) concurrently with radiotherapy. Median total dose to point A was 74 Gy (range: 66-92 Gy) for group I and 66 Gy (range: 40-98 Gy) for group II. Median follow-up time was 46 months. Patient and tumor characteristics were similar in both groups. The mean number of chemotherapy cycles was also comparable with 87% and 80% of patients receiving at least 4 doses in groups I and II, respectively. Seven patients (44%) of group I and 8 patients (53%) of group II developed tumor recurrence. The Median Survival time was not reached for Group I and 53 months for group II. The proportion of patients surviving at 2 and 5 years was 78% and 54% for group I and 73% and 43% for group II respectively. This small prospective study shows that weekly paclitaxel does not provide any clinical advantage over weekly cisplatin for concurrent chemoradiation for advanced carcinoma of the cervix

  9. Optimal Timing for Assessment of Tumor Response to Neoadjuvant Chemoradiation in Patients With Rectal Cancer: Do All Patients Benefit From Waiting Longer Than 6 Weeks?

    International Nuclear Information System (INIS)

    Perez, Rodrigo O.; Habr-Gama, Angelita; São Julião, Guilherme P.; Gama-Rodrigues, Joaquim; Sousa, Afonso H.S.; Campos, Fabio Guilherme; Imperiale, Antonio R.; Lynn, Patricio B.; Proscurshim, Igor; Nahas, Sergio Carlos; Ono, Carla Rachel; Buchpiguel, Carlos Alberto

    2012-01-01

    Purpose: To estimate the metabolic activity of rectal cancers at 6 and 12 weeks after completion of chemoradiation therapy (CRT) by 2-[fluorine-18] fluoro-2-deoxy-D-glucose-labeled positron emission tomography/computed tomography ([ 18 FDG]PET/CT) imaging and correlate with response to CRT. Methods and Materials: Patients with cT2-4N0-2M0 distal rectal adenocarcinoma treated with long-course neoadjuvant CRT (54 Gy, 5-fluouracil-based) were prospectively studied ( (ClinicalTrials.org) identifier (NCT00254683)). All patients underwent 3 PET/CT studies (at baseline and 6 and 12 weeks from CRT completion). Clinical assessment was at 12 weeks. Maximal standard uptake value (SUVmax) of the primary tumor was measured and recorded at each PET/CT study after 1 h (early) and 3 h (late) from 18 FDG injection. Patients with an increase in early SUVmax between 6 and 12 weeks were considered “bad” responders and the others as “good” responders. Results: Ninety-one patients were included; 46 patients (51%) were “bad” responders, whereas 45 (49%) patients were “good” responders. “Bad” responders were less likely to develop complete clinical response (6.5% vs. 37.8%, respectively; P=.001), less likely to develop significant histological tumor regression (complete or near-complete pathological response; 16% vs. 45%, respectively; P=.008) and exhibited greater final tumor dimension (4.3 cm vs. 3.3 cm; P=.03). Decrease between early (1 h) and late (3 h) SUVmax at 6-week PET/CT was a significant predictor of “good” response (accuracy of 67%). Conclusions: Patients who developed an increase in SUVmax after 6 weeks were less likely to develop significant tumor downstaging. Early-late SUVmax variation at 6-week PET/CT may help identify these patients and allow tailored selection of CRT-surgery intervals for individual patients.

  10. CLINICAL AND ANGIOGRAPHIC PROFILE OF PATIENTS WITH COMPLETE HEART BLOCK

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    Kavya Pingali

    2017-05-01

    Full Text Available BACKGROUND The angiographic findings and prognosis of patients with Complete Heart Block (CHB remain unclear. Thus, we aimed to study the clinical profile, risk factors, angiographic distribution and in-hospital outcomes of patients with complete heart block. MATERIALS AND METHODS This was a prospective, single-centred study which included 100 patients who came to the emergency department with CHB. Routine blood investigations including serum electrolytes were done. Coronary angiogram was done and lesions were assessed. Temporary pacemaker was implanted followed by permanent pacemakers in required patients, and in-hospital complications were noted down. RESULTS Commonest age group was above 60 years (75%. The patients were predominantly males. Most common presentation was chest pain (60%; there was regional wall motion abnormality in 30% patients. Degenerative complete heart block was seen in 34% patients, diphtheric myocarditis in 15%, hypokalaemic in 15%, dilated cardiomyopathy in 2%. Of total 53 patients had AV block, 14 had bifascicular block, 23 had LBBB, 6 had RBBB, 3 had Mobitz I and 1 had Mobitz II. Inferior wall myocardial infarction (MI was pervasively present in patients. Temporary pacemakers were implanted in 6 patients and permanent pacemakers in 43 patients. In-hospital outcomes constituted of complication like cardiogenic shock (10% and death (26%. The patients who died either had 80% -90% stenosis in RCA, triple vessel disease, ostioproximal LAD occlusion or diphtheric myocarditis. CONCLUSION Complete heart block was majorly associated with advanced age and inferior wall MI, virtually caused by dominant RCA occlusion. The in-hospital mortality was significantly higher in the patients with CHB.

  11. A 12-week interdisciplinary rehabilitation trial in patients with gliomas

    DEFF Research Database (Denmark)

    Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek

    2018-01-01

    rehabilitation intervention of physical therapy and occupational therapy in the initial treatment phase of patients with gliomas whose Karnofsky performance status is ≥70 is safe and feasible, if relevant inclusion criteria and precautionary screening are made. With the revised protocol, we are confident...

  12. Medical image of the week: acute encephalopathy in a multiple myeloma patient

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    Ateeli H

    2018-02-01

    Full Text Available No abstract available. A 45-year-old man with new diagnosis of multiple myeloma waiting to start treatment presented with worsening dizziness, blurred vision that progressed to altered mental status over a week. His physical exam revealed confusion but no focal deficit. His extensive work up showed no abnormality except for mildly elevated serum viscosity. The patient was started immediately on plasmapheresis. He also received dexamethasone, thalidomide and cyclophosphamide. His symptoms resolved completely within a few days of therapy. Serum viscosity measurements do not correlate well with symptoms or the clinical findings of hypervicosity syndrome. Plasmapheresis promptly relieves the symptoms and should be performed in symptomatic patients regardless of the viscosity level (1,2.

  13. Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial.

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    Bernard, Louis; Dinh, Aurélien; Ghout, Idir; Simo, David; Zeller, Valerie; Issartel, Bertrand; Le Moing, Vincent; Belmatoug, Nadia; Lesprit, Philippe; Bru, Jean-Pierre; Therby, Audrey; Bouhour, Damien; Dénes, Eric; Debard, Alexa; Chirouze, Catherine; Fèvre, Karine; Dupon, Michel; Aegerter, Philippe; Mulleman, Denis

    2015-03-07

    Duration of treatment for patients with vertebral osteomyelitis is mainly based on expert recommendation rather than evidence. We aimed to establish whether 6 weeks of antibiotic treatment is non-inferior to 12 weeks in patients with pyogenic vertebral osteomyelitis. In this open-label, non-inferiority, randomised controlled trial, we enrolled patients aged 18 years or older with microbiologically confirmed pyogenic vertebral osteomyelitis and typical radiological features from 71 medical care centres across France. Patients were randomly assigned to either 6 weeks or 12 weeks of antibiotic treatment (physician's choice in accordance with French guidelines) by a computer-generated randomisation list of permuted blocks, stratified by centre. The primary endpoint was the proportion of patients who were classified as cured at 1 year by a masked independent validation committee, analysed by intention to treat. Non-inferiority would be declared if the proportion of cured patients assigned to 6 weeks of treatment was not less than the proportion of cured patients assigned to 12 weeks of treatment, within statistical variability, by an absolute margin of 10%. This trial is registered with EudraCT, number 2006-000951-18, and Clinical Trials.gov, number NCT00764114. Between Nov 15, 2006, and March 15, 2011, 359 patients were randomly assigned, of whom six in the 6-week group and two in the 12-week group were excluded after randomisation. 176 patients assigned to the 6-week treatment regimen and 175 to the 12-week treatment regimen were analysed by intention to treat. 160 (90·9%) of 176 patients in the 6-week group and 159 (90·9%) of 175 of those in the 12-week group met the criteria for clinical cure. The difference between the groups (0·05%, 95% CI -6·2 to 6·3) showed the non-inferiority of the 6-week regimen when compared with the 12-week regimen. 50 patients in the 6-week group and 51 in the 12-week group had adverse events, the most common being death (14 [8%] in

  14. Effects of 12-week supervised treadmill training on spatio-temporal gait parameters in patients with claudication.

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    Konik, Anita; Kuklewicz, Stanisław; Rosłoniec, Ewelina; Zając, Marcin; Spannbauer, Anna; Nowobilski, Roman; Mika, Piotr

    2016-01-01

    The purpose of the study was to evaluate selected temporal and spatial gait parameters in patients with intermittent claudication after completion of 12-week supervised treadmill walking training. The study included 36 patients (26 males and 10 females) aged: mean 64 (SD 7.7) with intermittent claudication. All patients were tested on treadmill (Gait Trainer, Biodex). Before the programme and after its completion, the following gait biomechanical parameters were tested: step length (cm), step cycle (cycle/s), leg support time (%), coefficient of step variation (%) as well as pain-free walking time (PFWT) and maximal walking time (MWT) were measured. Training was conducted in accordance with the current TASC II guidelines. After 12 weeks of training, patients showed significant change in gait biomechanics consisting in decreased frequency of step cycle (p gait was more regular, which was expressed via statistically significant decrease of coefficient of variation (p 0.05). Twelve-week treadmill walking training programme may lead to significant improvement of temporal and spatial gait parameters in patients with intermittent claudication. Twelve-week treadmill walking training programme may lead to significant improvement of pain-free walking time and maximum walking time in patients with intermittent claudication.

  15. Abnormal Moral Reasoning in Complete and Partial Callosotomy Patients

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    Miller, Michael B.; Sinnott-Armstrong, Walter; Young, Liane; King, Danielle; Paggi, Aldo; Fabri, Mara; Polonara, Gabriele; Gazzaniga, Michael S.

    2010-01-01

    Recent neuroimaging studies suggest lateralized cerebral mechanisms in the right temporal parietal junction are involved in complex social and moral reasoning, such as ascribing beliefs to others. Based on this evidence, we tested 3 anterior-resected and 3 complete callosotomy patients along with 22 normal subjects on a reasoning task that…

  16. Long-term (52-week) safety and efficacy of Sacubitril/valsartan in Asian patients with hypertension.

    Science.gov (United States)

    Supasyndh, Ouppatham; Sun, Ningling; Kario, Kazuomi; Hafeez, Kudsia; Zhang, Jack

    2017-05-01

    Sacubitril/valsartan (LCZ696), a first-in-class angiotensin receptor-neprilysin inhibitor, demonstrated significant reductions in office and 24 h ambulatory blood pressure (BP) over 8 weeks in Asian patients with hypertension. This 52-week extension to the 8-week core study was aimed at evaluating the long-term safety, tolerability and efficacy of sacubitril/valsartan. Patients who completed an 8-week randomized study (the core study) were enrolled in this 52-week open-label study and received sacubitril/valsartan 200 mg QD. The sacubitril/valsartan dose was uptitrated to 400 mg QD if BP was uncontrolled (>140/90 mm Hg) after 4 weeks. Subsequently, in patients with uncontrolled BP, treatment was intensified every 4 weeks with amlodipine 5-10 mg followed by hydrochlorothiazide 6.25-25 mg. Of the 341 patients enrolled, 7 (2.1%) discontinued the study drug due to adverse events (AEs). The incidence of AEs and serious AEs were 63.9 and 3.8%, respectively, and no deaths were reported in this study. The most frequent AEs were nasopharyngitis (18.2%) and dizziness (8.8%). Events that were potentially indicative of low BP were infrequent. One patient reported mild transient angioedema (lasting 2.5 h) that resolved without treatment but led to study drug discontinuation. The sacubitril/valsartan-based regimen provided clinically significant mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) reductions from baseline (-24.7/-16.2 mm Hg). The overall BP control, msSBP and msDBP response rates were 75.3, 90.6 and 87.6%, respectively. Long-term use of sacubitril/valsartan was generally safe and well-tolerated in patients with hypertension and provided significant BP reductions from baseline.

  17. Efficacy of an Eight Week Trial of Imipramine and Citalopram in Patients with Mixed Anxiety-Depressive Disorder

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    Mohammad Reza Abbasi-Asl

    2008-12-01

    Full Text Available "n "nObjective: Mixed anxiety-depressive disorder (MADD is a condition in which patients have both anxiety and depressive symptoms but do not meet the diagnostic criteria for either an anxiety disorder or a mood disorder. "nThe aim of this study was to compare the efficacy of imipramine and citalopram in the treatment of MADD. "n "nMethods: Fifty one outpatients aged 18 to 55 who were diagnosed with MADD were randomly assigned to receive citalopram or imipramine for 8 weeks. Patients were assessed using Hamilton Depression Rating Scale (HDRS and Hamilton Anxiety Rating Scale (HARS at baseline, weeks 4 and "n8 of the study. The mean differences in Hamilton scores from the baseline  were used as the main outcome measures of response to treatment. "n "nResults: Thirty six patients completed the study. Patients in the citalopram group (n=20 received a mean dosage of 22 mg per day during the first 4 weeks and a mean dosage of 33 mg per day during weeks 4 to 8. Subjects in the Imipramine group (n= 16 received a mean dosage of 77 mg per day during the first 4 weeks and a mean dosage of 89 mg per day during weeks 4 "nto 8. It was noted that the both treatments were effective on depression and anxiety at the end of the fourth and eighth weeks. However, the mean differences of HDRS and HARS scores between citalopram and imipramine groups were not significantly different at the end of weeks 4 and 8. "n "nConclusion: The results of this study suggest that the efficacy of regular doses of citalopram is comparable with lower range of therapeutic doses of imipramine in the treatment of MADD. A more comprehensive study is warranted to confirm the results of this study.

  18. Conventional Complete Denture in Patients with Ectodermal Dysplasia

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    Larissa Soares Reis Vilanova

    2015-01-01

    Full Text Available Ectodermal dysplasia is described as heritable conditions that involve anomalies of structures derived from the ectoderm, including hypodontia. In the cases of edentulous young patients, who did not finish their craniofacial growth, treatment with conventional complete denture is a suitable alternative. The aim of this study was to report a case of mandibular edentulism treated with conventional complete denture in a thirteen-year-old patient diagnosed with hidrotic ectodermal dysplasia. Typical features, such as frontal bossing, depressed nasal bridge, protuberant lips, scarce hair, and brittle nails, were visualized during the extraoral examination. The intraoral inspection and radiographic analysis revealed oligodontia, dental malformation, and prolonged retention of deciduous teeth at maxilla and total edentulism at mandible. A conventional complete denture was planned and constructed following the same steps of technique as recommended in adults. Although this option is not a definitive treatment, the patient and his parents were satisfied with his improvement in chewing and speech, as well as with the aesthetic benefits.

  19. Phase I dose-finding study of cabazitaxel administered weekly in patients with advanced solid tumours

    International Nuclear Information System (INIS)

    Fumoleau, Pierre; Trigo, Jose Manuel; Isambert, Nicolas; Sémiond, Dorothée; Gupta, Sunil; Campone, Mario

    2013-01-01

    Cabazitaxel is approved in patients with metastatic hormone-refractory prostate cancer previously treated with a docetaxel-containing regimen. This study evaluated a weekly cabazitaxel dosing regimen. Primary objectives were to report dose-limiting toxicities (DLTs) and to determine the maximum tolerated dose (MTD). Efficacy, safety and pharmacokinetics were secondary objectives. Cabazitaxel was administered weekly (1-hour intravenous infusion at 1.5–12 mg/m2 doses) for the first 4 weeks of a 5-week cycle in patients with solid tumours. Monitoring of DLTs was used to determine the MTD and the recommended weekly dose. Thirty-one patients were enrolled. Two of six patients experienced DLTs at 12 mg/m 2 , which was declared the MTD. Gastrointestinal disorders were the most common adverse event. Eight patients developed neutropenia (three ≥ Grade 3); one occurrence of febrile neutropenia was reported. There were two partial responses (in breast cancer) and 13 patients had stable disease (median duration of 3.3 months). Increases in C max and AUC 0–t were dose proportional for the 6–12 mg/m 2 doses. The MTD of weekly cabazitaxel was 12 mg/m 2 and the recommended weekly dose was 10 mg/m 2 . The observed safety profile and antitumour activity of cabazitaxel were consistent with those observed with other taxanes in similar dosing regimens. The study was registered with ClinicalTrials.gov as http://www.clinicaltrials.gov/ct2/show/NCT01755390

  20. Prosthodontic rehabilitation of completely edentulous patient with partial glossectomy

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    Aditi Garg

    2016-01-01

    Full Text Available Oral cancer accounts for about 40% of all cancers inflicting the human beings. Those involving the tongue results in mild to severe deficiencies of phonation, deglutition, mastication, and taste depending upon the degree and extent tissues involved. Often rehabilitation of such patient is a challenge for the prosthodontist and involves a careful observation and evaluation of the residual oral function and ways to restore them. This article presents a case report of prosthodontic rehabilitation completely edentulous patient, who underwent partial glossectomy following surgical resection of the squamous cell carcinoma involving left lateral borders of the tongue. An attempt was made to restore the comfort and function of the patient with the help of palatal augmentation prosthesis, with additional assistance through speech therapy and simple oral exercises.

  1. The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study.

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    Yataba, Ikuko; Otsuka, Noboru; Matsushita, Isao; Matsumoto, Hideo; Hoshino, Yuichi

    2016-08-01

    The newly developed S-flurbiprofen plaster (SFPP) is a tape-type patch that shows innovative percutaneous absorption. This study was designed to evaluate the safety of a long-term 52-week SFPP application to osteoarthritis (OA) patients. This was a multi-center, open-label, uncontrolled prospective study that included 201 OA patients. SFPP at 40 mg/day was applied to the site of pain in 101 patients and at 80 mg/day (2 patches) in 100 patients at a total of 301 sites for 52 weeks. The affected sites assessed included the knee (192), lumbar spine (66), cervical spine (26), and others (17). Drug safety was evaluated by medical examination, laboratory tests, and examination of vital signs. Efficacy was evaluated by the patient's and clinician's global assessments and clinical symptoms. Most patients (80.1 %) completed the 52-week SFPP application. The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46.8 % of the sites. No photosensitive dermatitis was observed. Systemic AEs occurred in 9.0 % of the patients; a serious AE (gastric ulcer hemorrhage) occurred in one patient. No clinically significant changes in the laboratory tests and vital signs were observed. The efficacy evaluation showed an improvement from 2 weeks after the SFPP application, which continued during the 52 weeks' treatment. No apparent safety concerns were observed, even during the long-term SFPP application. Therefore, SFPP could be an additional pharmacotherapy in OA treatment.

  2. Impact of a 12-week wellness coaching on self-care behaviors among primary care adult patients with prediabetes

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    Ramona S. DeJesus

    2018-06-01

    Full Text Available This single arm prospective study assessed the impact of individualized wellness coaching intervention for primary care patients with prediabetes on self-reported changes in physical activity level and food choices. Five hundred sixty adult patients 18 years and older with prediabetes, seen in primary care clinic, were invited to participate in 12 weeks wellness coaching sessions delivered by certified coaches. Responses from questionnaires at baseline, 6 and 12 weeks were analyzed. Of 168 consented patients, 99 completed at least one coaching session; majority was elderly, female, overweight or obese. At baseline, 50% had <60 min aerobic exercise/week. At 6 and 12 weeks, average aerobic exercise time significantly increased from 117 min to 166 and 199 min respectively. Effect was sustained at 24 weeks. Success in making healthy eating choices also statistically improved from baseline. Significant effects on both activity level and eating behavior persisted even after adjusting for age, sex and baseline glucose/A1c values. Secondary outcomes of self-efficacy and quality of life likewise showed significant improvement. Results suggest that integration of wellness coaching in primary care practice among individuals at high risk for diabetes is feasible and may be useful as part of diabetes prevention management strategies in target populations. Future randomized clinical trials are needed to further explore this issue. Keywords: Wellness coaching, Primary care, Prediabetes, Preventive health, Health behavior

  3. Weekly ascorbic acid infusion in castration-resistant prostate cancer patients

    DEFF Research Database (Denmark)

    Nielsen, Torben K.; Højgaard, Martin; Andersen, Jon T.

    2017-01-01

    of this treatment. Methods: This non-comparative, single-center, phase II trial included patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer (mCRPC) from an outpatient clinic to evaluate the efficacy and safety of IV AA therapy. Patients received weekly infusions of AA (week 1, 5 g....../L was recorded at week 12. Among the secondary endpoints, no signs of disease remission were observed. In total, 53 adverse events (AEs) were recorded. Eleven were graded as "serious". Three AEs were directly related to AA, and all of which were related to fluid load. Conclusions: Infusion with 60 g of AA did...

  4. Weekly ascorbic acid infusion in castration-resistant prostate cancer patients

    DEFF Research Database (Denmark)

    Nielsen, Torben K.; Højgaard, Martin; Andersen, Jon T.

    2017-01-01

    of this treatment.  Methods: This non-comparative, single-center, phase II trial included patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer (mCRPC) from an outpatient clinic to evaluate the efficacy and safety of IV AA therapy. Patients received weekly infusions of AA (week 1, 5 g...... μg/L was recorded at week 12. Among the secondary endpoints, no signs of disease remission were observed. In total, 53 adverse events (AEs) were recorded. Eleven were graded as "serious". Three AEs were directly related to AA, and all of which were related to fluid load.  Conclusions: Infusion...

  5. Procalcitonin Levels in Patients with Complete and Incomplete Kawasaki Disease

    Directory of Open Access Journals (Sweden)

    Hwa Jin Cho

    2013-01-01

    Full Text Available Incomplete Kawasaki disease (iKD is considered to be a less complete form of Kawasaki disease (cKD, and several differences in the laboratory presentations of iKD and cKD have been noted. We investigated serum procalcitonin levels in patients with iKD, cKD, and other febrile diseases (a control group. Seventy-seven patients with cKD, 24 with iKD, and 41 controls admitted to our hospital from November 2009 to November 2011 were enrolled in the present study. We obtained four measurements of serum procalcitonin levels and those of other inflammatory markers from each patient. Samples were taken for analysis on the day of diagnosis (thus before treatment commenced; D0 and 2 (D2, 14 (D14, and 56 days (D56 after intravenous immunoglobulin infusion. We obtained control group data at D0. The mean D0 serum procalcitonin levels of cKD patients (0.71±1.36 ng/mL and controls (0.67±1.06 ng/mL were significantly higher than those of iKD patients (0.26±0.26 ng/mL (P=0.014 and P=0.041, resp.. No significant difference in mean procalcitonin level was evident among groups at any subsequent time. In conclusion, the serum procalcitonin level of patients with acute-stage cKD was significantly higher than that of iKD patients.

  6. Unexplained week-to-week variation in BNP and NT-proBNP is low in chronic heart failure patients during steady state

    DEFF Research Database (Denmark)

    Schou, Morten; Gustafsson, Finn; Nielsen, Per H

    2006-01-01

    BACKGROUND: The usefulness of brain-natriuretic-peptide (BNP) and N-terminal-pro-brain-natriuretic-peptide (NT-proBNP) for monitoring of chronic heart failure (CHF) patients has been questioned because of high levels of unexplained variation. AIMS: Week-to-week total variance (CV(T)), unexplained...

  7. Early rebleeding and death at 6 weeks in alcoholic cirrhotic patients ...

    African Journals Online (AJOL)

    Background. This study evaluated the incidence of rebleeding and death at 6 weeks after a first episode of acute variceal haemorrhage (AVH) treated by emergency endoscopic sclerotherapy in a large cohort of alcoholic cirrhotic patients. Methods. From January 1984 to December 2006, 310 alcoholic cirrhotic patients (242 ...

  8. Partner-assisted emotional disclosure for patients with GI cancer: 8-week follow-up and processes associated with change.

    Science.gov (United States)

    Porter, Laura S; Keefe, Francis J; Baucom, Donald H; Hurwitz, Herbert; Moser, Barry; Patterson, Emily; Kim, Hong Jin

    2012-08-01

    We recently reported that a partner-assisted emotional disclosure intervention for gastrointestinal cancer led to improvements in relationship quality and intimacy for couples in which the patient initially reported higher levels of holding back from discussing cancer-related concerns. The purposes of the present study were to examine outcomes at 8-week follow-up and process variables that may influence treatment effects. One hundred thirty couples were randomly assigned to either partner-assisted emotional disclosure or an education/support control condition. Participants completed measures of relationship quality, intimacy, and psychological distress before randomization, post-treatment, and 8 weeks later. Patients in the disclosure intervention completed measures of negative affect immediately following each treatment session, and their level of expressiveness during the sessions was rated by trained observers. Data were analyzed using multilevel modeling. Among couples in which the patient initially reported higher levels of holding back, the disclosure intervention led to improvements in relationship quality and intimacy that were maintained at 8-weeks follow-up. High levels of patient expressiveness during the disclosure sessions were associated with improvements in relationship quality and intimacy, and high levels of patient negative affect immediately following the sessions were associated with reductions in psychological distress at the post-test assessment. For couples in which the patient tends to hold back from discussing concerns, partner-assisted emotional disclosure is a beneficial intervention leading to improvements in relationship functioning that maintain over time. Future research is needed to examine methods of enhancing intervention effects, including encouraging patient expressiveness and negative affect during the sessions.

  9. A Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation: First Report of Acute Toxicity, Feasibility, and Patient Satisfaction

    Energy Technology Data Exchange (ETDEWEB)

    Dragun, Anthony E., E-mail: aedrag01@louisville.edu [Department of Radiation Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Quillo, Amy R. [Department of Surgical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Riley, Elizabeth C. [Department of Medical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Roberts, Teresa L.; Hunter, Allison M. [Department of Radiation Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Rai, Shesh N. [Department of Biostatistics and Epidemiology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Callender, Glenda G. [Department of Surgical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Jain, Dharamvir [Department of Medical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); McMasters, Kelly M. [Department of Surgical Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States); Spanos, William J. [Department of Radiation Oncology, University of Louisville School of Medicine, James Graham Brown Cancer Center, Louisville, Kentucky (United States)

    2013-03-01

    Purpose: To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS). Methods and Materials: Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patients were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23). Results: Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade ≥2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity—pain requiring a course of narcotic analgesics—was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period. Conclusions: The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes.

  10. A Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation: First Report of Acute Toxicity, Feasibility, and Patient Satisfaction

    International Nuclear Information System (INIS)

    Dragun, Anthony E.; Quillo, Amy R.; Riley, Elizabeth C.; Roberts, Teresa L.; Hunter, Allison M.; Rai, Shesh N.; Callender, Glenda G.; Jain, Dharamvir; McMasters, Kelly M.; Spanos, William J.

    2013-01-01

    Purpose: To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS). Methods and Materials: Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patients were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23). Results: Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade ≥2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity—pain requiring a course of narcotic analgesics—was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period. Conclusions: The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes

  11. Precision oncology in advanced cancer patients improves overall survival with lower weekly healthcare costs

    Science.gov (United States)

    Haslem, Derrick S.; Chakravarty, Ingo; Fulde, Gail; Gilbert, Heather; Tudor, Brian P.; Lin, Karen; Ford, James M.; Nadauld, Lincoln D.

    2018-01-01

    The impact of precision oncology on guiding treatment decisions of late-stage cancer patients was previously studied in a retrospective analysis. However, the overall survival and costs were not previously evaluated. We report the overall survival and healthcare costs associated with precision oncology in these patients with advanced cancer. Building on a matched cohort study of 44 patients with metastatic cancer who received all of their care within a single institution, we evaluated the overall survival and healthcare costs for each patient. We analyzed the outcomes of 22 patients who received genomic testing and targeted therapy (precision oncology) between July 1, 2013 and January 31, 2015, and compared to 22 historically controlled patients (control) who received standard chemotherapy (N = 17) or best supportive care (N = 5). The median overall survival was 51.7 weeks for the targeted treatment group and 25.8 weeks for the control group (P = 0.008) when matching on age, gender, histological diagnosis and previous treatment lines. Average costs over the entire period were $2,720 per week for the targeted treatment group and $3,453 per week for the control group, (P = 0.036). A separate analysis of 1,814 patients with late-stage cancer diagnoses found that those who received a targeted cancer treatment (N = 93) had 6.9% lower costs in the last 3 months of life compared with those who did not. These findings suggest that precision oncology may improve overall survival for refractory cancer patients while lowering average per-week healthcare costs, resource utilization and end-of-life costs. PMID:29552312

  12. 15 years steam generator experience in German PWR power plants; part II: replacement of two completely assembled steam generators within ten weeks

    International Nuclear Information System (INIS)

    Scheuktanz, G.; Bouecker, R.; Riess, R.; Soellner, P.; Stieding, L.; Termeuhlen, H.

    1984-01-01

    This paper reports on the replacement of two steam generators at the Obrigheim power plant during a 10-week period, including a description of the methods and equipment used to do so. It is concluded that the method should be used only if transportation conditions within the reactor building preclude a complete system exchange and that one of the main reasons for the success of this operation was the very close relationship established between plant personnel and the equipment supplier and contractor, a relationship which began when the project was in the planning stage

  13. Gestational age and birth weight in relation to school performance of 10-year-old children: a follow-up study of children born after 32 completed weeks

    DEFF Research Database (Denmark)

    Kirkegaard, Ida; Obel, Carsten; Hedegaard, Morten

    2006-01-01

    BACKGROUND: Children born extremely premature (weight (weight. Much less is known about children of higher gestational ages and birth weights. We studied gestational age...... after 32 completed weeks and birth weight in relation to the child's school performance at the age of 10 years. METHODS: We performed a follow-up study of 5319 children born between January 1990 and June 1992. We got the information on birth weight and gestational age from birth registration forms; when...... the children were between 9 and 11 years of age, we gathered information about their school performance (reading, spelling, and arithmetic) from questionnaires completed by the parents and the children's primary school teachers. RESULTS: The association between birth weight and reading, as well as spelling...

  14. The completeness of chest X-ray procedure codes in the Danish National Patient Registry

    Directory of Open Access Journals (Sweden)

    Hjertholm P

    2017-03-01

    Full Text Available Peter Hjertholm,1 Kaare Rud Flarup,1 Louise Mahncke Guldbrandt,1 Peter Vedsted1,2 1Research Center for Cancer Diagnosis in Primary Care, Department of Public Health, 2University Clinic for Innovative Health Care Delivery, Diagnostic Centre, Silkeborg Hospital, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark Objective: The aim of this validation study was to assess the completeness of the registrations of chest X-rays (CXR in two different versions of the Danish National Patient Registry (DNPR. Material and methods: We included electronic record data on CXR performed on patients aged 40 to 99 years from nine radiology departments covering 20 Danish hospitals. From each department, we included data from three randomly selected weeks between 2004 and 2011 (reference standard. In two versions of the DNPR from the State Serum Institute (SSI and Statistics Denmark, respectively, we investigated the proportion of registered CXR compared to the reference standard. Furthermore, we compared the completeness of the recorded data according to the responsible department (main department. Results: We identified 11,235 patients and 12,513 CXR in the reference standard. The data from the SSI contained 12,265 (98% CXR, whereas the data from Statistics Denmark comprised 9,151 (73.1% CXR. The completeness of the SSI data was fairly constant across years, radiology departments, medical specialties, and age groups. The data from Statistics Denmark was almost complete in 2011 (95.8%. However, for the remaining study period, the data with radiology departments registered as the main department were lacking in the version from Statistics Denmark, and so the overall completeness was 73.1%. Conclusion: The completeness of CXR registrations varied between 98% and 73% depending on the information source, and this should be considered when investigating radiology services in the basis of DNPR. Keywords: chest X-ray, Danish National Patient Registry

  15. An 8-Week Neuromuscular Exercise Program for Patients With Mild to Moderate Knee Osteoarthritis

    DEFF Research Database (Denmark)

    Clausen, Brian; Holsgaard-Larsen, Anders; Roos, Ewa M

    2017-01-01

    OBJECTIVE:   To describe the feasibility of a neuromuscular exercise (NEMEX) program in patients with mild to moderate knee osteoarthritis (KOA). BACKGROUND:   Neuromuscular exercise has been increasingly used in patients with osteoarthritis to achieve sensorimotor control and improved daily...... function. TREATMENT:   A study of the first 23 physically active patients (11 men, 12 women; age range = 48-70 years) who had mild to moderate KOA and were undergoing an 8-week, twice-weekly program, consisting of 11 exercises with 3 to 4 levels of difficulty, as part of an ongoing randomized controlled...... to increased (n = 2) or persisting (n = 1) knee pain. However, their pain ratings did not show worsening symptoms. UNIQUENESS:   This NEMEX-KOA program was designed for physically active middle-aged patients with mild to moderate KOA; therefore, it involved exercises and difficulty levels that were more...

  16. Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck.

    Science.gov (United States)

    Trieu, Vanessa; Pinto, Harlan; Riess, Jonathan W; Lira, Ruth; Luciano, Richard; Coty, Jessie; Boothroyd, Derek; Colevas, A Dimitrios

    2018-03-14

    Chemotherapy for recurrent, metastatic squamous cell carcinoma of the head and neck need not be known for extreme toxicity.The weekly regimen studied here has been demonstrated to be tolerable and effective. The objective of this study was to establish the response rate, progression-free survival (PFS) and overall survival (OS), and safety profile of weekly docetaxel, platinum, and cetuximab (TPC) in patients with relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN). Twenty-nine patients with metastatic or recurrent SCCHN with an Eastern Cooperative Oncology Group (ECOG) performance status <3 were enrolled in an institutional review board-approved phase II trial. This study permitted prior chemoradiation, radiation, and/or surgery, provided that 3 months had elapsed since the end of the potentially curative treatment. Patients received cisplatin 30 mg/m 2 or carboplatin area under the curve (AUC) 2, docetaxel 30 mg/m 2 , and cetuximab 250 mg/m 2 weekly for 3 weeks, followed by a break during the fourth week, for a 28-day cycle. Planned intrapatient dose modifications were based on individual toxicity. Twenty-seven patients received TPC and were evaluable for response and toxicity. Rates of complete response (CR), partial response (PR), and confirmed PR were 3%, 52%, and 30%, respectively. The overall objective response rate was 56%. Estimated median PFS and OS were 4.8 and 14.7 months, respectively. The rates of grade 3 and 4 worst-grade adverse events (AEs) per patient were 85% and 7%, respectively. Dose density through cycle 4 was preserved for all patients; however, treatment beyond cycle 6 with the TPC regimen proved unfeasible. Weekly docetaxel, cisplatin, and cetuximab is an effective regimen for patients with metastatic or recurrent SCCHN. Response rates, PFS, and OS compare favorably with other combination chemotherapy treatments. Grade 4 toxicity rates observed in this study were substantially lower than those described with regimens

  17. Feasibility of Incremental 2-Times Weekly Hemodialysis in Incident Patients With Residual Kidney Function

    Directory of Open Access Journals (Sweden)

    Andrew I. Chin

    2017-09-01

    Discussion: More than 50% of incident HD patients with RKF have adequate kidney urea clearance to be considered for 2-times weekly HD. When additionally ultrafiltration volume and blood pressure stability are taken into account, more than one-fourth of the total cohort could optimally start HD in an incremental fashion.

  18. Measurement of weekly prostate specific antigen levels in patients receiving pelvic radiotherapy for nonprostatic malignancies

    International Nuclear Information System (INIS)

    Vijayakumar, Srinivasan; Quadri, S. Farhat; Sen, Saunak; Vaida, Florin; Ignacio, Lani; Weichselbaum, R. R.

    1995-01-01

    Purpose: To study the response of nonmalignant prostatic tissue to ionizing irradiation in terms of the resultant changes in serum prostate specific antigen (PSA) levels. Methods and Materials: Weekly serum PSA values were determined during radiotherapy (RT) in nine patients ('treatment group') without clinical evidence of prostate cancer (PC), and who received pelvic RT for other indications. Slopes for the rate of change in PSA was determined using model: log PSA = β0 + β1 * week + β2 * week 2 + error. These results are compared with 17 normal volunteers ('control group') who were not exposed to ionizing irradiation. An attempt is made to compare any similarities and differences in subsets of 64 T1-T4N0M0 PC patients who received pelvic RT. Results: An elevation in the serum PSA levels were noted in eight of nine patients in the 'treatment group' with a median time of 4.2 weeks to reach the maximum serum PSA values. After an initial increase, PSA values declined. In some patients, manifold increase in PSA was noted, for example, from 1.8 to 13.5 ng/ml and 3.3 to 9.8 ng/ml in two patients. The PSA increase ranged from 50-650%. The median slope was 0.601 week -1 (range 0.192-3.045 week -1 ). No such increases were seen in the 'control group' (median slope = 0.03 week -1 ; range, 0.18-0.13 week -1 ). When differences between the mean increase/decrease for each week compared to pretreatment values were analyzed, the irradiated group had statistically significant elevations in the PSA for weeks 3 (p = 0.034), 4 (p = 0.035), and 5 (p 0.024). A similar trend of increasing PSA levels during radiotherapy was noted in prostate cancer patients whose initial PSA values were ≤ 20 ng/ml: whereas positive slopes (i.e., increasing PSA levels during radiotherapy course) was seen in 7.1% of those with > 20 ng/ml preradiotherapy PSA values, such trends were seen in 52.7% of those with ≤ 20 ng/ml preradiotherapy PSA values. Conclusions: (a) Incidental exposure of noncancerous

  19. Measurement of weekly prostate specific antigen levels in patients receiving pelvic radiotherapy for nonprostatic malignancies

    Energy Technology Data Exchange (ETDEWEB)

    Vijayakumar, Srinivasan; Quadri, S Farhat; Sen, Saunak; Vaida, Florin; Ignacio, Lani; Weichselbaum, R R

    1995-04-30

    Purpose: To study the response of nonmalignant prostatic tissue to ionizing irradiation in terms of the resultant changes in serum prostate specific antigen (PSA) levels. Methods and Materials: Weekly serum PSA values were determined during radiotherapy (RT) in nine patients ('treatment group') without clinical evidence of prostate cancer (PC), and who received pelvic RT for other indications. Slopes for the rate of change in PSA was determined using model: log PSA = {beta}0 + {beta}1{sup *}week + {beta}2{sup *}week{sup 2} + error. These results are compared with 17 normal volunteers ('control group') who were not exposed to ionizing irradiation. An attempt is made to compare any similarities and differences in subsets of 64 T1-T4N0M0 PC patients who received pelvic RT. Results: An elevation in the serum PSA levels were noted in eight of nine patients in the 'treatment group' with a median time of 4.2 weeks to reach the maximum serum PSA values. After an initial increase, PSA values declined. In some patients, manifold increase in PSA was noted, for example, from 1.8 to 13.5 ng/ml and 3.3 to 9.8 ng/ml in two patients. The PSA increase ranged from 50-650%. The median slope was 0.601 week{sup -1} (range 0.192-3.045 week{sup -1}). No such increases were seen in the 'control group' (median slope = 0.03 week{sup -1}; range, 0.18-0.13 week{sup -1}). When differences between the mean increase/decrease for each week compared to pretreatment values were analyzed, the irradiated group had statistically significant elevations in the PSA for weeks 3 (p = 0.034), 4 (p = 0.035), and 5 (p 0.024). A similar trend of increasing PSA levels during radiotherapy was noted in prostate cancer patients whose initial PSA values were {<=} 20 ng/ml: whereas positive slopes (i.e., increasing PSA levels during radiotherapy course) was seen in 7.1% of those with > 20 ng/ml preradiotherapy PSA values, such trends were seen in 52.7% of those with {<=} 20 ng/ml preradiotherapy PSA values

  20. Clinical Outcomes of Image Guided Adaptive Hypofractionated Weekly Radiation Therapy for Bladder Cancer in Patients Unsuitable for Radical Treatment

    Energy Technology Data Exchange (ETDEWEB)

    Hafeez, Shaista, E-mail: shaista.hafeez@icr.ac.uk [The Institute of Cancer Research, London (United Kingdom); The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); McDonald, Fiona; Lalondrelle, Susan [The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); McNair, Helen; Warren-Oseni, Karole; Jones, Kelly [The Institute of Cancer Research, London (United Kingdom); The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); Harris, Victoria [The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); Taylor, Helen; Khoo, Vincent [The Royal Marsden NHS Foundation Trust, London (United Kingdom); Thomas, Karen [The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); Hansen, Vibeke; Dearnaley, David; Horwich, Alan; Huddart, Robert [The Institute of Cancer Research, London (United Kingdom); The Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom)

    2017-05-01

    Purpose and Objectives: We report on the clinical outcomes of a phase 2 study assessing image guided hypofractionated weekly radiation therapy in bladder cancer patients unsuitable for radical treatment. Methods and Materials: Fifty-five patients with T2-T4aNx-2M0-1 bladder cancer not suitable for cystectomy or daily radiation therapy treatment were recruited. A “plan of the day” radiation therapy approach was used, treating the whole (empty) bladder to 36 Gy in 6 weekly fractions. Acute toxicity was assessed weekly during radiation therapy, at 6 and 12 weeks using the Common Terminology Criteria for Adverse Events version 3.0. Late toxicity was assessed at 6 months and 12 months using Radiation Therapy Oncology Group grading. Cystoscopy was used to assess local control at 3 months. Cumulative incidence function was used to determine local progression at 1 at 2 years. Death without local progression was treated as a competing risk. Overall survival was estimated using the Kaplan-Meier method. Results: Median age was 86 years (range, 68-97 years). Eighty-seven percent of patients completed their prescribed course of radiation therapy. Genitourinary and gastrointestinal grade 3 acute toxicity was seen in 18% (10/55) and 4% (2/55) of patients, respectively. No grade 4 genitourinary or gastrointestinal toxicity was seen. Grade ≥3 late toxicity (any) at 6 and 12 months was seen in 6.5% (2/31) and 4.3% (1/23) of patients, respectively. Local control after radiation therapy was 92% of assessed patients (60% total population). Cumulative incidence of local progression at 1 year and 2 years for all patients was 7% (95% confidence interval [CI] 2%-17%) and 17% (95% CI 8%-29%), respectively. Overall survival at 1 year was 63% (95% CI 48%-74%). Conclusion: Hypofractionated radiation therapy delivered weekly with a plan of the day approach offers good local control with acceptable toxicity in a patient population not suitable for radical bladder treatment.

  1. Clinical Outcomes of Image Guided Adaptive Hypofractionated Weekly Radiation Therapy for Bladder Cancer in Patients Unsuitable for Radical Treatment

    International Nuclear Information System (INIS)

    Hafeez, Shaista; McDonald, Fiona; Lalondrelle, Susan; McNair, Helen; Warren-Oseni, Karole; Jones, Kelly; Harris, Victoria; Taylor, Helen; Khoo, Vincent; Thomas, Karen; Hansen, Vibeke; Dearnaley, David; Horwich, Alan; Huddart, Robert

    2017-01-01

    Purpose and Objectives: We report on the clinical outcomes of a phase 2 study assessing image guided hypofractionated weekly radiation therapy in bladder cancer patients unsuitable for radical treatment. Methods and Materials: Fifty-five patients with T2-T4aNx-2M0-1 bladder cancer not suitable for cystectomy or daily radiation therapy treatment were recruited. A “plan of the day” radiation therapy approach was used, treating the whole (empty) bladder to 36 Gy in 6 weekly fractions. Acute toxicity was assessed weekly during radiation therapy, at 6 and 12 weeks using the Common Terminology Criteria for Adverse Events version 3.0. Late toxicity was assessed at 6 months and 12 months using Radiation Therapy Oncology Group grading. Cystoscopy was used to assess local control at 3 months. Cumulative incidence function was used to determine local progression at 1 at 2 years. Death without local progression was treated as a competing risk. Overall survival was estimated using the Kaplan-Meier method. Results: Median age was 86 years (range, 68-97 years). Eighty-seven percent of patients completed their prescribed course of radiation therapy. Genitourinary and gastrointestinal grade 3 acute toxicity was seen in 18% (10/55) and 4% (2/55) of patients, respectively. No grade 4 genitourinary or gastrointestinal toxicity was seen. Grade ≥3 late toxicity (any) at 6 and 12 months was seen in 6.5% (2/31) and 4.3% (1/23) of patients, respectively. Local control after radiation therapy was 92% of assessed patients (60% total population). Cumulative incidence of local progression at 1 year and 2 years for all patients was 7% (95% confidence interval [CI] 2%-17%) and 17% (95% CI 8%-29%), respectively. Overall survival at 1 year was 63% (95% CI 48%-74%). Conclusion: Hypofractionated radiation therapy delivered weekly with a plan of the day approach offers good local control with acceptable toxicity in a patient population not suitable for radical bladder treatment.

  2. Cisplatin improves antitumor activity of weekly nab-paclitaxel in patients with metastatic breast cancer

    Directory of Open Access Journals (Sweden)

    Sun S

    2014-03-01

    Full Text Available Si Sun,1 Lichen Tang,2 Jian Zhang,1 Fangfang Lv,1 Zhonghua Wang,1 Leiping Wang,1 Qunling Zhang,1 Chunlei Zheng,1 Lixin Qiu,1 Zhen Jia,1 Yunhua Lu,1 Guangyu Liu,2 Zhimin Shao,2 Biyun Wang,1 Xichun Hu1 1Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China, 2Department of Breast Surgery, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China Abstract: Although nanoparticle albumin-bound paclitaxel (nab-paclitaxel is approved to be given every 3 weeks, weekly use of this drug is becoming a new standard of care in patients with metastatic breast cancer (MBC. This prospective Phase II study was conducted to improve the efficacy of weekly nab-paclitaxel with cisplatin in MBC patients. Seventy-three women with recurrent or MBC were eligible for participation. Nab-paclitaxel was administered weekly at a dose of 125 mg/m2 on day 1, day 8, and day 15, followed by cisplatin 75 mg/m2 on day 1, repeated every 28 days with a maximum of 6 cycles. The primary objective was investigator-assessed overall response rate (ORR. A high ORR of 67.1% was obtained, with rates of 80.6% for the first-line patients and 80% for patients not pretreated with taxanes. Among those who had objective responses, a large percentage of patients (83.7% showed quickly remarkable tumor shrinkage during the first two cycles. The median progression-free and overall survival times were 9.8 and 26.9 months, respectively. For the patients receiving first-, second-, and third-line therapy or beyond, median progression-free survival was 11.7, 7.7, and 7.6 months, respectively (P=0.005. Molecular subtype was not significantly associated with ORR or disease progression. Grade 4 neutropenia occurred in 46 patients (63.0%, with febrile neutropenia found in 9 patients (12.3%. Grade 3

  3. Treatment with Ipilimumab: A Case Report of Complete Response in a Metastatic Malignant Melanoma Patient

    Directory of Open Access Journals (Sweden)

    Alfredo Addeo

    2013-05-01

    Full Text Available Introduction: Over the past year, 3 agents have been approved for the treatment of melanoma by the Food and Drug Administration. These include pegylated interferon α-2b for stage III melanoma, vemurafenib for unresectable or metastatic melanoma with BRAF V600E mutation, and ipilimumab for unresectable or metastatic melanoma. Case Presentation: We present here the case of a 65-year-old Caucasian male diagnosed with advanced melanoma in April 2011 and treated with ipilimumab (Yervoy®, a monoclonal antibody targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4, as second-line treatment after progression with dacarbazine, for (wild-type BRAF metastatic melanoma. The patient was referred to us for several painful lumps on his right arm. A biopsy of one of them revealed melanoma. CT and PET scans did not show any other lesions or a primary site. The patient was started on first-line chemotherapy with dacarbazine 850 mg/m2 on day 1, every 3 weeks. After 3 cycles, the patient showed disease progression with an increase in size of the skin metastasis. Second-line treatment was started with ipilimumab 3 mg/kg on day 1, every 3 weeks. At the end of the treatment, after 4 cycles, we documented a complete clinical response with total resolution of the skin metastasis. At the time of writing this paper, our patient had finished his treatment more than 9 months earlier and is still in complete remission. Conclusion: This is a paradigmatic case where, despite extensive metastatic disease, treatment with ipilimumab has confirmed its efficacy. It is still an open question why only a minority of patients have such a remarkable response, and further trials are warranted to address this important question.

  4. Patient perceptions of risky drinking: Knowledge of daily and weekly low-risk guidelines and standard drink sizes.

    Science.gov (United States)

    Sprague, Debra J; Vinson, Daniel C

    2017-01-01

    Effective intervention for risky drinking requires that clinicians and patients know low-risk daily and weekly guidelines and what constitutes a "standard drink." The authors hypothesized that most patients lack this knowledge, and that education is required. Following primary care visits, patients completed anonymous exit questionnaires that included the 3 Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questions, "How many drinks (containing alcohol) can you safely have in one day?" and questions about size, in ounces, of a standard drink of wine, beer, and liquor. Descriptive analyses were done in Stata. Of 1,331 respondents (60% female, mean age: 49.6, SD = 17.5), 21% screened positive on the AUDIT-C for risky drinking. Only 10% of those accurately estimated daily low-risk limits, with 9% accurate on weekly limits, and half estimated low-risk limits at or below guidelines. Fewer than half who checked "Yes" to "Do you know what a 'standard drink' is?" provided accurate answers for beer, wine, or liquor. Patients with a positive screen were twice as likely to say they knew what a standard drink is, but only a third gave accurate estimates. When asked about plans in the next month regarding change in drinking behavior, 23% with a positive AUDIT-C indicated they were at least considering a change. Most patients in primary care don't know specifics of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines for low-risk drinking. Exploring patient perceptions of low-risk guidelines and current drinking behavior may reveal discrepancies worth discussing. For risky drinkers, most of whom don't know daily and weekly low-risk guidelines or standard drink sizes, education can be vital in intervening. Findings suggest the need for detailed and explicit social marketing and communication on exactly what low-risk drinking entails.

  5. Effect of resilient liner on masticatory efficiency and general patient satisfaction in completely edentulous patients

    DEFF Research Database (Denmark)

    Mangtani, Nidhi; Pillai, Rajath; Babu, Dinesh

    2015-01-01

    Objectives: To assess the effect of resilient lined denture on patient masticatory efficiency, general patient satisfaction and denture quality as compare to conventional complete denture over a period of one year. Material and methodology: A total of 28 completely edentulous patients (14 males...... denture liner – group 2). All patients were clinically evaluated to assess the denture quality, and administered questionnaires for masticatory efficiency and patients general satisfaction level at three intervals i.e. one month (T0), 6 months (T1) and 1 year post-insertion (T2). Results: Statistical...... masticatory efficiency improved significantly over time in controls, while in experimental group masticatory efficiency remained the same (p>.05) for almost all the questions. Patient general satisfaction score at different time intervals for each question showed no significant difference (P>.05) on inter...

  6. Hospitalization in daily home hemodialysis and matched thrice-weekly in-center hemodialysis patients.

    Science.gov (United States)

    Weinhandl, Eric D; Nieman, Kimberly M; Gilbertson, David T; Collins, Allan J

    2015-01-01

    Cardiovascular disease is a common cause of hospitalization in dialysis patients. Daily hemodialysis improves some parameters of cardiovascular function, but whether it associates with lower hospitalization risk is unclear. Observational cohort study using US Renal Data System data. Medicare-enrolled daily (5 or 6 sessions weekly) home hemodialysis (HHD) patients initiating NxStage System One use from January 1, 2006, through December 31, 2009, and contemporary thrice-weekly in-center hemodialysis patients, matched 5 to 1. Daily HHD or thrice-weekly in-center hemodialysis. All-cause and cause-specific hospital admissions, hospital readmissions, and hospital days assessed from Medicare Part A claims. For 3,480 daily HHD and 17,400 thrice-weekly in-center hemodialysis patients in intention-to-treat analysis, the HR of all-cause admission for daily HHD versus in-center hemodialysis was 1.01 (95%CI, 0.98-1.03). Cause-specific admission HRs were 0.89 (95%CI, 0.86-0.93) for cardiovascular disease, 1.18 (95%CI, 1.13-1.23) for infection, 1.01 (95%CI, 0.93-1.09) for vascular access dysfunction, and 1.02 (95%CI, 0.99-1.06) for other morbidity. Regarding cardiovascular disease, first admission and readmission HRs for daily HHD versus in-center hemodialysis were 0.91 and 0.87, respectively. Regarding infection, first admission and readmission HRs were 1.35 and 1.03, respectively. Protective associations of daily HHD with heart failure and hypertensive disease were most pronounced, as were adverse associations of daily HHD with bacteremia/sepsis, cardiac infection, osteomyelitis, and vascular access infection. Results may be confounded by unmeasured factors, including vascular access type; information about dialysis frequency, duration, and dose was lacking; causes of admission may be misclassified; results may not apply to patients without Medicare coverage. All-cause hospitalization risk was similar in daily HHD and thrice-weekly in-center hemodialysis patients. However

  7. Assessment of a sixteen-week training program on strength, pain, and function in rheumatoid arthritis patients.

    Science.gov (United States)

    Flint-Wagner, Hilary G; Lisse, Jeffrey; Lohman, Timothy G; Going, Scott B; Guido, Terri; Cussler, Ellen; Gates, Donald; Yocum, David E

    2009-06-01

    To assess the effects of a 16-week progressive, individualized, high-intensity strength training program on muscle strength, pain, and function in patients with rheumatoid arthritis (RA). Twenty-four RA patients (men, n = 5; women, n = 19) receiving infliximab participated in a randomized controlled trial. The strength training (ST) group (n = 16) participated in a supervised program 3 times per week, and the control (C) group (n = 8) continued with standard of care as overseen by their rheumatologist. Assessments were completed at baseline and at weeks 8 and 16. Strength was measured by 3 repetition maximum (3RM), isometric hand dynamometer, and isokinetic dynamometer. A 100-mm visual analogue scale was used to assess pain. Functional performance was derived from a timed 50-foot walk and the Health Assessment Questionnaire Disability Index. The mean percent increase in strength (3RM) for the ST group from baseline to week 16 was 46.1% +/- 31.6% (P < 0.01) (mean of all three 3RM exercises: hammer curl, leg press, and incline dumbbell press), with mean gains in strength up to 4 times that of baseline values reported in all strength training exercises (upper and lower body) performed during exercise sessions. On average, right-hand grip strength increased by 2.9 +/- 4.0 kg in the ST group, in comparison with a loss of 1.2 +/- 3.0 kg in the C group over 16 weeks. The ST group had a 53% reduction in pain, in comparison with almost no change in the C group. The ST group had a significant improvement in 50-foot walk time, with a mean reduction of -1.2 +/- 1.6 seconds, in comparison with the C group (mean increase of 0.8 +/- 1.0 seconds; P = 0.01) over the 16 weeks. There was a clinically important difference (predefined as mean change +/-0.25) in the Health Assessment Questionnaire Disability Index in the ST group (-0.4 +/- 0.4) but not in the C group (-0.1 +/- 0.4). High-intensity strength training in RA patients with varying levels of disease activity and joint damage

  8. Treatment with α-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading

    Directory of Open Access Journals (Sweden)

    Hector Garcia-Alcala

    2015-01-01

    Full Text Available Effective treatment of diabetic sensorimotor polyneuropathy remains a challenge. To assess the efficacy and safety of α-lipoic acid (ALA over 20 weeks, we conducted a multicenter randomized withdrawal open-label study, in which 45 patients with type 2 diabetes and symptomatic polyneuropathy were initially treated with ALA (600 mg tid for 4 weeks (phase 1. Subsequently, responders were randomized to receive ALA (600 mg qd; n=16 or to ALA withdrawal (n=17 for 16 weeks (phase 2. During phase 1, the Total Symptom Score (TSS decreased from 8.9 ± 1.8 points to 3.46 ± 2.0 points. During phase 2, TSS improved from 3.7 ± 1.9 points to 2.5 ± 2.5 points in the ALA treated group (p<0.05 and remained unchanged in the ALA withdrawal group. The use of analgesic rescue medication was higher in the ALA withdrawal group than ALA treated group (p<0.05. In conclusion, in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose (600 mg tid administration of ALA, subsequent treatment with ALA (600 mg qd over 16 weeks improved neuropathic symptoms, whereas ALA withdrawal was associated with a higher use of rescue analgesic drugs. This trial is registered with ClinicalTrials.gov Identifier: NCT02439879.

  9. Comparison of Dosage Requirement of Erythropoietin Stimulating Agent (ESA in Maintenance of Hemoglobin Concentration in patients undergoing twice weekly versus thrice weekly Hemodialysis in Pakistani Population

    Directory of Open Access Journals (Sweden)

    Osama Kunwer Naveed

    2018-03-01

    Full Text Available Anemia is one of the major complications of patients with chronic kidney disease (CKD undergoing hemodialysis (HD and is associated with left ventricular hypertrophy and also increases morbidity and mortality. Anemia in patients with CKD can be due to two major reasons; iron deficiency or erythropoietin insufficiency. Erythropoietin Stimulating Agent (ESAs administration is the mainstay in treating anemia if the patient is iron sufficient. However, higher doses of ESAs have been associated with increased cerebrovascular and cardiovascular events. We conducted this study to see how much erythropoietin is required in our setting in iron sufficient patients to maintain hemoglobin(Hb  level and the effect of dialysis frequency on ESA doses.  Methods and Findings: A cross-sectional study was conducted at the Department of Nephrology at Ziauddin University Hospital. Patients’ charts were reviewed for Hb levels and doses of ESA to maintain Hb between 10-12 mg/dl. Patients were excluded if they had iron deficiency, malignancy, were on immunosuppressive agents, had renal transplant, and with Hb >12 mg/dl or <10 mg/dl and their ferritin levels, transferrin saturation, hemoglobin concentration, frequency of hemodialysis and ESA dosage were monitored. We also compared these variables between patients undergoing hemodialysis thrice weekly with those undergoing hemodialysis twice a week. A total of 105 patients were analyzed. 24 were excluded as they did not match the inclusion criteria. 81 patients were included in the study. 36 (44.4% were males and 45 (55.6% were females. Mean age of the patient was 56.47 ± 11.72 years. The average dose of ESA was 106.91 ± 61.47 for patients undergoing hemodialysis thrice weekly and 183.94 ± 116.71 for patients undergoing hemodialysis twice a week. Significant difference was found to exist between dosage of patients undergoing thrice weekly dialysis versus twice weekly dialysis(p=<0.001.  Our study has limitations

  10. Early preeclampsia and HELLP syndrome in a 20 week pregnant patient

    Directory of Open Access Journals (Sweden)

    Fatemeh Keighobadi Khajeh

    2017-01-01

    Full Text Available The first time Weinstein in 1982 described patients with the syndrome of hemolysis, elevated liver enzymes, and low platelet count (HELLP in pregnant preeclamptic and eclamptic patients. This syndrome is a severe form of preeclampsia or eclampsia. Usually HELLP syndrome occurs at the third trimester and only 15% occur before the 27th week of pregnancy and rarely before the 20th week of pregnancy. We want to present a 30- year old parity 2, gravidity 1 pregnant patient who was pregnant for 20 weeks with preeclampsia and HELLP syndrome. Two hours before arriving to the emergency unit, she felt chest discomfort and went to the nearest clinic to visit a physician. She was then referred to the hospital because of high blood pressure (BP. When she arrived to the emergency unit, she had right upper quadrant and epigastric pain, headache, vomiting, dyspnea, and high BP (185/100. Finally the diagnosis of HELLP syndrome was made. As maternal and fetus mortality and morbidity of HELLP syndrome is high, immediate recognition and treatment is vital to save the lives of both the mother and the fetus

  11. Completeness of pedigree and family cancer history for ovarian cancer patients.

    Science.gov (United States)

    Son, Yedong; Lim, Myong Cheol; Seo, Sang Soo; Kang, Sokbom; Park, Sang Yoon

    2014-10-01

    To investigate the completeness of pedigree and of number of pedigree analysis to know the acceptable familial history in Korean women with ovarian cancer. Interview was conducted in 50 ovarian cancer patients for obtaining familial history three times over the 6 weeks. The completeness of pedigree is estimated in terms of familial history of disease (cancer), health status (health living, disease and death), and onset age of disease and death. The completion of pedigree was 79.3, 85.1, and 85.6% at the 1st, 2nd, and 3rd time of interview and the time for pedigree analysis was 34.3, 10.8, and 3.1 minutes, respectively. The factors limiting pedigree analysis were as follows: out of contact with their relatives (38%), no living ancestors who know the family history (34%), dispersed family member because of the Korean War (16%), unknown cause of death (12%), reluctance to ask medical history of relatives (10%), and concealing their ovarian cancer (10%). The percentage of cancers revealed in 1st (2%) and 2nd degree (8%) relatives were increasing through surveys, especially colorectal cancer related with Lynch syndrome (4%). Analysis of pedigree at least two times is acceptable in Korean woman with ovarian cancer from the first study. The completion of pedigree is increasing, while time to take family history is decreasing during three time survey.

  12. Effects of a 10-week weight control program on obese patients with schizophrenia or schizoaffective disorder: a 12-month follow up.

    Science.gov (United States)

    Chen, Chih-Ken; Chen, Yi-Chih; Huang, Yu-Shu

    2009-02-01

    Weight gain secondary to antipsychotic medication is associated with many serious conditions, including type II diabetes mellitus, hypertension, and coronary heart disease, and also with poor medication compliance. Weight control programs may be of benefit to outpatients with schizophrenia, but also raise an issue of cost-effectiveness. We aimed to evaluate the effectiveness of a 10-week weight control program for outpatients taking atypical antipsychotics for treatment of schizophrenia, and to follow up the effects of this weight control program in controlling weight gain after termination of the program. A total of 33 patients with schizophrenia and antipsychotic-related obesity were enrolled in a 10-week multimodal weight control program. The patients' weights were recorded at baseline, week 4, week 8, week 10 (end of the intervention), week 12, week 24, and week 48. Secondary measures included blood sugar levels, cholesterol levels, triglyceride levels, quality of life and mental health. For those who completed the weight control program, there was a mean weight loss of 2.1 kg by the end of the intervention, 3.7 kg over 6 months, and 2.7 kg over 12 months. The mean body mass index decreased by 0.8, 1.5 and 1.1 at week 10, week 24 and week 48, respectively, all with statistical significance. The 10-week weight control program was effective in terms of weight reduction among obese patients with schizophrenia or schizoaffective disorder, and the weight reduction effect lasted for up to 6 months, and up to 12 months in some cases.

  13. Benefits of a 7-week outpatient pulmonary rehabilitation program in COPD patients.

    Science.gov (United States)

    Croitoru, Alina; Ioniţă, Diana; Stroescu, Carmen; Pele, Irina; Gologanu, Daniela; Dumitrescu, Andreea; Marinescu, Lucia; Anghelescu, Dana; Alexandru, Miron; Bogdan

    2013-01-01

    Respiratory rehabilitation programs (RR) are essential tools in the management of COPD. We present the results of a 7-week outpatient rehabilitation program in terms of dyspnea, exercise tolerance and quality of life. The following parameters were evaluated before and after RR: dyspnea (mMRC scale), pulmonary function (FEVI, RV- residual volume), exercise tolerance (6MWT- 6 minutes walk test, CPET - cardiopulmonary exercise test), quality of life (SGROQ questionnaire). The RR program was outpatient, hospital based (7 weeks, 3 sessions/ week) and included: exercise training, therapeutic education, and psychological support. 25 patients, COPD stage II-IV GOLD (mean FEVI 44.5 +/-13% predicted), mean age 60.4 +/-12 years, 7 females, average BMI 27.14+/-4 kg/m2, average RV residual volume 221.55+/-86% predicted. Mean 6MWTdistance: 407.48 +/- 84 m and mean maximum power (Pmax) obtained on CPET: 75.67+/-30 Watts. All patients were symptomatic with significant dyspnea (3.06+/-0.7 on mMRC scale) and showed a significant impairment of quality of life: SGRO score 46.23+/- 14. At the end of RR program: dyspnea decreased with 0.67points on mMRC scale (p = 0.000), 6MWT distance increased with 58.5 m (p = 0.0071), Pmax obtained during CPET increased with 11.2 W, without reaching statistical significance (p> 0.05). SGRO score decreased by 5.59 points (p = 0.02). There were no significant improvements in FEV1 and RV values (p> 0.05). In our COPD patients, the 7 week outpatient rehabilitation program was effective, leading to improvement ofsymptoms, exercise tolerance and quality of life.

  14. Once-weekly albiglutide in the management of type 2 diabetes: patient considerations.

    Science.gov (United States)

    Woodward, Heather N; Anderson, Sarah L

    2014-01-01

    This review describes the pharmacologic, pharmacokinetic, and pharmacodynamic properties of albiglutide, as well as its clinical efficacy and safety. Albiglutide is a novel, once-weekly, injectable glucagon-like peptide-1 receptor agonist for the treatment of type 2 diabetes. The European Commission recently granted marketing authorization for the drug in the European Union and on April 15, 2014, the US Food and Drug Administration approved albiglutide (Tanzeum™ [GlaxoSmithKline LLC, Wilmington, DE, USA]) to improve glycemic control in adults with type 2 diabetes. Albiglutide has been studied in Phase I, II, and III clinical trials. In the Phase III clinical trials, known as the Harmony series, weekly dosing of albiglutide demonstrated reductions in fasting plasma glucose, postprandial plasma glucose, and glycated hemoglobin, and was associated with weight loss. In all phases of the clinical trials, albiglutide administered once weekly showed a safety and tolerability profile similar to that of placebo, with mild gastrointestinal-related complaints and injection site erythema being the most commonly encountered adverse effects. Compared with pioglitazone and liraglutide, albiglutide has been shown to be clinically less effective. However, it offers the benefit of weight loss that pioglitazone does not, with fewer gastrointestinal side effects than liraglutide. As guidelines continue to advocate for patient-centered treatment strategies, once-weekly albiglutide will be an important addition to the growing armamentarium of treatment options for adults with type 2 diabetes needing target glycemic control.

  15. Rehabilitation of a patient with complete mandibulectomy and partial glossectomy

    International Nuclear Information System (INIS)

    Meyerson, M.D.; Johnson, B.H.; Weitzman, R.S.

    1980-01-01

    Following a number of radiologic and surgical procedures for the treatment of oral cancer, a patient with severe facial difigurement and alteration of the vocal tract acquired acceptable speech. Consultation among referring physicians and speech pathologists can aid such a patient by facilitating the rehabilitative process through improvement of communicative skills

  16. Effects of 12-week combined exercise therapy on oxidative stress in female fibromyalgia patients.

    Science.gov (United States)

    Sarıfakıoğlu, Banu; Güzelant, Aliye Yıldırım; Güzel, Eda Celik; Güzel, Savaş; Kızıler, Ali Rıza

    2014-10-01

    The aims of this study were to investigate the effect of exercise therapy on the oxidative stress in fibromyalgia patients and relationship between oxidative stress and fibromyalgia symptoms. Thirty women diagnosed with fibromyalgia according to the American College of Rheumatology preliminary criteria, and 23 healthy women whose age- and weight-matched women were enrolled the study. Pain intensity with visual analog scale (VAS), the number of tender points, the fibromyalgia impact questionnaire (FIQ), the Beck depression inventory (BDI) were evaluated. The oxidative stress parameters thiobarbituric acid reactive substances, protein carbonyls, and nitric oxide, and antioxidant parameters thiols and catalase were investigated in patients and control group. After, combined aerobic and strengthen exercise regimen was given to fibromyalgia group. Exercise therapy consisted of a warming period of 10 min, aerobic exercises period of 20 min, muscle strengthening exercises for 20 min, and 10 min cooling down period. Therapy was lasting 1 h three times per week over a 12-week period. All parameters were reevaluated after the treatment in the patient group. The oxidative stress parameters levels were significantly higher, and antioxidant parameters were significantly lower in patients with fibromyalgia than in the controls. VAS, FIQ, and BDI scores decreased significantly with exercise therapy. The exercise improved all parameters of oxidative stress and antioxidant parameters. Also, all clinical parameters were improved with exercise. We should focus on oxidative stress in the treatment for fibromyalgia with the main objective of reducing oxidative load.

  17. Effects of 8 weeks of mat-based Pilates exercise on gait in chronic stroke patients.

    Science.gov (United States)

    Roh, SuYeon; Gil, Ho Jong; Yoon, Sukhoon

    2016-09-01

    [Purpose] The purpose of this study was to investigate the effects of an 8-week program of Pilates exercise on gait in chronic hemiplegia patients and to determine whether or not it can be used for rehabilitation in postsrtoke patients. [Subjects and Methods] Twenty individuals with unilateral chronic hemiparetic stroke (age, 66.1 ± 4.4 yrs; height, 162.3 ± 8.3 cm; weight, 67.4 ± 12.3 kg) participated in this study and were randomly allocated equally to either a Pilates exercise group or a control group. To identify the effects of Pilates exercise, a 3-D motion analysis with 8 infrared cameras was performed. [Results] For the gait parameters, improvements were found in the Pilates exercise group for all variables, and statistical significance was observed for stride length, gait velocity, knee range of motion and hip range of motion. For the asymmetry indexes, insignificant improvements were found for all variables in the Pilates exercise group. [Conclusion] In conclusion, an 8-week program of Pilates exercise had a positive influence on improving the gait ability of poststroke patients, and the intervention could be applied to poststroke patients with various levels of physical disability by adjusting the intensity of training.

  18. Rehabilitation of Bell's palsy patient with complete dentures.

    Science.gov (United States)

    Muthuvignesh, J; Kumar, N Suman; Reddy, D Narayana; Rathinavelu, Pradeep; Egammai, S; Adarsh, A

    2015-08-01

    Facial nerve disorders may be of sudden onset and more often of unknown etiology. Edema of the facial nerve within the fallopian canal results in Bell's palsy. This causes compression of the nerve and affects the microcirculation. Many authors have suggested treatment for facial nerve paralysis ranging from simple physiotherapy to complicated microvascular decompression. It more often results in symptoms like synkinesis and muscle spasm after the decompression surgery of the nerve because of the inability to arrange the nerve fibers within the canal. The treatment choice also depends on patient's age, extent of the nerve damage, and patient's needs and desires. Many patients who cannot be rehabilitated functionally can be treated for esthetics of the involved muscles. This case report elaborates about a patient who was rehabilitated for esthetics and to some extent for function.

  19. Reservoir Complete Denture in a Patient with Xerostomia ...

    African Journals Online (AJOL)

    These have a significant negative impact on patient's health and overall ... Jaw relation was recorded with wax occlusal rims fabricated on self-cure acrylic .... In summary, this paper reports a technique for the construction of the mandibular ...

  20. One week treatment with the IL-1 receptor antagonist anakinra leads to a sustained improvement in insulin sensitivity in insulin resistant patients with type 1 diabetes mellitus.

    Science.gov (United States)

    van Asseldonk, Edwin J P; van Poppel, Pleun C M; Ballak, Dov B; Stienstra, Rinke; Netea, Mihai G; Tack, Cees J

    2015-10-01

    Inflammation associated with obesity is involved in the development of insulin resistance. We hypothesized that anti-inflammatory treatment with the Interleukin-1 receptor antagonist anakinra would improve insulin sensitivity. In an open label proof-of-concept study, we included overweight patients diagnosed with type 1 diabetes with an HbA1c level over 7.5%. Selecting insulin resistant patients with longstanding type 1 diabetes allowed us to study the effects of anakinra on insulin sensitivity. Patients were treated with 100mg anakinra daily for one week. Insulin sensitivity, insulin need and blood glucose profiles were measured before, after one week and after four weeks of follow-up. Fourteen patients completed the study. One week of anakinra treatment led to an improvement of insulin sensitivity, an effect that was sustained for four weeks. Similarly, glucose profiles, HbA1c levels and insulin needs improved. In conclusion, one week of treatment with anakinra improves insulin sensitivity in patients with type 1 diabetes. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Effects of a one week multidisciplinary inpatient self-management programme for patients with fibromyalgia: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hamnes Bente

    2012-09-01

    Full Text Available Abstract Background Self-management programmes (SMP are recommended for patients with fibromyalgia. The purpose of this study was to evaluate effects of a one week multidisciplinary inpatient self-management programme on psychological distress, skills as a consumer of health services, self-efficacy, and functional and symptomatic consequences of fibromyalgia (FM. Methods A randomised controlled two-armed, assessor-blinded trial with three-week follow-up to evaluate SMP. Primary outcomes were the General Health Questionnaire (GHQ-20 and the Effective Musculoskeletal Consumer Scale (EC-17, while secondary outcomes included the Fibromyalgia Impact Questionnaire (FIQ and Self-efficacy scales for pain, function and symptoms (ASES. Results 150 patients with FM were randomised to one week one SMP (n = 75 or to a waiting list control group (n = 75. Of these, 58 participants in the treatment group and 60 in the control group completed the study. At three weeks’ follow up there was a significant difference in EC-17 (0-100 in favour of the treatment group (mean difference 4.26, 95 CI 0.8 to 7.7, p = 0.02. There were no differences between the groups for any of the other outcomes. Conclusion This study shows that in patients with FM the SMP had no effect on psychological distress, functional and symptomatic consequences and self-efficacy, except for a small short-term effect on skills and behaviour that are important for managing and participating in health care (EC-17. Clinical Trials.gov Id: NCT01035125. Trial registration Clinical Trials.gov Id: NCT01035125

  2. Tamsulosin does not increase 1-week passage rate of ureteral stones in ED patients.

    Science.gov (United States)

    Berger, David A; Ross, Michael A; Hollander, Jay B; Ziadeh, James; Chen, Charity; Jackson, Raymond E; Swor, Robert A

    2015-12-01

    The objective of the study is to determine if tamsulosin initiated in the emergency department (ED) decreases the time to ureteral stone passage at 1 week or time to pain resolution, compared to placebo. We performed a prospective, randomized, double-blinded, placebo-controlled trial of tamsulosin vs placebo in ED patients with ureterolithiasis on computed tomography. Patients were identified and enrolled between April 2007 and February 2009 and were randomized to either 0.4 mg of tamsulosin or placebo for 1 week. We contacted participants using a telephone survey on post-ED visit days 1, 2, 3, and 7. The primary outcome was time to stone passage, with secondary outcomes being maximum pain score and amount of pain medication required. Of the 127 patients enrolled during this study, 15 were lost to follow-up, and 12 required surgical interventions before the 7-day mark, leaving 100 patients for analysis. Of the 100 patients, 53 received tamsulosin and 47 received placebo. There was no difference between groups in percentage of male, mean age, initial serum creatinine, average stone size, stone location, and history of prior stone. The probability that the patient did not pass a stone at 7 days was not different between tamsulosin and placebo, 62.1% (95% confidence interval, 49.1%-75.1%) vs 54.4% (95% confidence interval, 40.3%-68.6%; P = .58). There was no significant difference in the high pain score (P = .12) or hydrocodone/acetaminophen intake (P = .76) between treatment groups at any of the time points. This study reveals no difference in the proportion of stone passage or high pain score and pain medication utilization at 7 days between tamsulosin and placebo. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Atomoxetine for Orthostatic Hypotension in an Elderly Patient Over 10 Weeks: A Case Report.

    Science.gov (United States)

    Hale, Genevieve M; Brenner, Michael

    2015-09-01

    Several nonpharmacologic strategies for orthostatic hypotension exist including avoiding large carbohydrate-rich meals; limiting alcohol consumption; maintaining adequate hydration; adding salt to foods; and using compression stockings, tilt-table exercises, or abdominal binders. If these fail, however, only limited evidence-based pharmacologic treatment options are available including the use of fludrocortisone, midodrine, pyridostigmine, and droxidopa as well as pseudoephedrine, ocetreotide, and atomoxetine. This report discusses a case of atomoxetine use for 10 weeks in an elderly patient with primary orthostatic hypotension. An 84-year-old man with long-standing primary orthostatic hypotension presented to our ambulatory cardiology pharmacotherapy clinic after several unsuccessful pharmacologic therapies including fludrocortisone, midodrine, and pyridostigmine. Nonpharmacologic strategies were also implemented. Atomoxetine was initiated, and the patient showed gradual improvements in symptoms and blood pressure control over the course of 10 weeks. Our data suggest that low-dose atomoxetine is an effective and safe agent for symptom improvement and blood pressure control in elderly patients with primary orthostatic hypotension. © 2015 Pharmacotherapy Publications, Inc.

  4. Word frequency and word stem completion in Korsakoff patients.

    NARCIS (Netherlands)

    Phaf, R,H.; Geurts, H.; Eling, P.

    2000-01-01

    Korsakoff patients are generally agreed to be impaired in conscious recollection, but whether their implicit memory performance is also affected is less certain. A deficit in novelty dependent encoding (i.e., elaboration learning) could account for both types of impairments and predicts a reduced

  5. Study protocol: non-displaced distal radial fractures in adult patients: three weeks vs. five weeks of cast immobilization: a randomized trial.

    Science.gov (United States)

    Bentohami, Abdelali; de Korte, Niels; Sosef, Nico; Goslings, Johan Carel; Bijlsma, Taco; Schep, Niels

    2014-01-20

    Up to 30% of patients suffer from long-term functional restrictions following conservative treatment of distal radius fractures. Whether duration of cast immobilisation influences functional outcome remains unclear. The aim of the study is to evaluate whether the duration of immobilization of non or minimally displaced distal radial fractures can be safely reduced. We will compare three weeks of plaster cast immobilization with five weeks of plaster cast immobilization in adult patient with non or minimally displaced distal radial fractures. a prospective randomized clinical trial. adult (>18 years) (independent in activities of daily living) patients with a non/minimal displaced distal radius fracture (dorsal angulation 15°, ulnar positive variance immobilization versus five weeks of plaster cast immobilization.Main study parameters: primary outcome parameters: Patient related wrist evaluation (PRWE) Quick Disability of Arm, Shoulder and Hand (QUICKDASH) score after a one year follow-up, and secondary parameters: range of motion, pain level (VAS) and complications. The expectation of this study is that shorter duration of plaster cast immobilisation is beneficial for the patient with a distal radius fracture. This risk of specific complications is low and generally similar in both treatment options. Moreover, the burden of the study is not much higher compared to standard treatment. Follow-up is standardized according to current trauma guidelines. Literature indicates that both treatment options from the study are accepted for displaced distal radius fractures. No clear advantage for one treatment options is found at present in the literature, although there is no level I evidence present. This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two treatment options for non-displaced distal radial fractures. The gathered data may support the development of a clinical guideline for conservative treatment of

  6. Barriers to completing TB diagnosis in Yemen: services should respond to patients' needs.

    Science.gov (United States)

    Anderson de Cuevas, Rachel M; Al-Sonboli, Najla; Al-Aghbari, Nasher; Yassin, Mohammed A; Cuevas, Luis E; Theobald, Sally J

    2014-01-01

    Obtaining a diagnosis of tuberculosis (TB) is a prerequisite for accessing specific treatment, yet one third of estimated new cases are missed worldwide by National Programmes. This study investigated economic, geographical, socio-cultural and health system factors hindering adults' attendance and completion of the TB diagnostic process in Yemen, to inform interventions designed to improve patient access to services. The study employed a mixed methods design comprising a cross-sectional survey and In-Depth-Interviews (IDIs) and Focus Group Discussions (FGDs) among patients abandoning the diagnosis or registering for treatment. Adults with cough of ≥ 2 weeks attending a large governmental referral centre in Sana'a, Yemen, between 2009 and 2010, were eligible to participate. 497 and 446 (89.7%) participants were surveyed the first and second day of attending the services and 48 IDIs and 12 FGDs were also conducted. The majority of patients were disadvantaged and had poor literacy (61% illiterate), had travelled from rural areas (47%) and attended with companions (84%). Key barriers for attendance identified were clinic and transport costs (augmented by companions), distance from home, a preference for private services, strong social stigma and a lack of understanding of the diagnostic process. There were discrepancies between patient- and doctor-reported diagnosis and 46% of patients were unaware that TB treatment is free. Females faced more difficulties to attend than men. The laboratory practice of providing first-day negative smear results and making referrals to the private sector also discouraged patients from returning. Strategies to bring TB diagnostic services closer to communities and address the multiple barriers patients face to attend, will be important to increase access to TB diagnosis and care.

  7. Concurrence of Serum Creatinine and Albumin with Lower Risk for Death in Twice-Weekly Hemodialysis Patients

    Science.gov (United States)

    Wang, Jialin; Streja, Elani; Soohoo, Melissa; Chen, Joline L.T.; Rhee, Connie M.; Kim, Taehee; Molnar, Miklos Z.; Kovesdy, Csaba P.; Mehrotra, Rajnish; Kalantar-Zadeh, Kamyar

    2016-01-01

    Objective Markers of better nutritional status including both higher levels of serum albumin (as a measure of visceral proteins) and creatinine (as a measure of the muscle mass) are associated with lower mortality in conventional (thrice-weekly) hemodialysis patients. However, data for these associations in twice-weekly hemodialysis patients, in whom less frequent hemodialysis may confound nutritional predictors, are lacking. Design, Settings and Subjects We identified 1,113 twice-weekly and matched 4,448 thrice-weekly hemodialysis patients from a large national dialysis cohort of incident hemodialysis patients over 5 years (2007-2011). Mortality risk, adjusted for potential confounders, was examined across two-by-two combinations of serum creatinine (creatinine≥6mg/dl and albumin≥3.5g/dl as reference, patients with creatininecreatinine mortality associations between twice-weekly and thrice-weekly hemodialysis patients (p-for-interaction 0.7667). Conclusions Surrogate markers of higher visceral protein and muscle mass combined may confer greatest survival in both twice-weekly and thrice-weekly hemodialysis patients. PMID:27528412

  8. Treatment with sirolimus results in complete responses in patients with autoimmune lymphoproliferative syndrome

    Science.gov (United States)

    Teachey, David T.; Greiner, Robert; Seif, Alix; Attiyeh, Edward; Bleesing, Jack; Choi, John; Manno, Catherine; Rappaport, Eric; Schwabe, Dirk; Sheen, Cecilia; Sullivan, Kathleen E.; Zhuang, Hongming; Wechsler, Daniel S.; Grupp, Stephan A.

    2010-01-01

    Summary We hypothesized that sirolimus, an mTOR inhibitor, may be effective in patients with autoimmune lymphoproliferative syndrome (ALPS) and treated patients who were intolerant to or failed other therapies. Four patients were treated for autoimmune cytopenias; all had a rapid complete or near complete response. Two patients were treated for autoimmune arthritis and colitis, demonstrating marked improvement. Three patients had complete resolution of lymphadenopathy and splenomegaly and all patients had a reduction in double negative T cells, a population hallmark of the disease. Based on these significant responses, we recommend that sirolimus be considered as second-line therapy for patients with steroid-refractory disease. PMID:19208097

  9. Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial.

    Science.gov (United States)

    Wagenaar, Inge; Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

    2017-10-01

    While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.

  10. Pathologic complete response in patients with neoadjuvant chemoradiotherapy for rectal cancer

    International Nuclear Information System (INIS)

    Espinola M, Daniela; Espinola M, Daniela; Bellolio R, Felipe; Gellona V, Jose; Bustos C, Mariza; Zuniga D, Alvaro

    2013-01-01

    Background: The standard treatment of locally advanced rectal cancer (RC) of the middle and lower third of the rectum is neoadjuvant chemoradiotherapy (XRQT) follow by oncologic resection. After this treatment in 15-25% of the cases, the pathologist reports complete pathological response (pCR). Aim: To describe demographic, clinical and survival data of patients with pCR undergoing chemoradiotherapy and radical resection for RC. Material and Methods: Historic cohort study. In a prospectively maintained database between 2000 and 2010, we identified patients with RC, who underwent neoadjuvant chemoradiotherapy according to protocol, followed by radical resection. The preoperative staging was obtained by clinical examination, endoscopy, rectal ultrasound, CT scan of chest, abdomen and pelvis and pelvic MRI. Demographic data, tumor location, time between the end of XRTQ and surgery, postoperative staging (according AJCC) and survival, were collected. Results: 119 patients received preoperative XRTQ, 65% male, with a mean age of 58 years. The most frequent tumor site was the lower third (63%). Surgery was performed 8 weeks after the end of XRTQ. Of 119 patients with XRTQ, 15.1% had a pCR. Overall survival was 75%, and cancer-specific survival was 80.4% at 5 years in patients without pCR. For patients with pCR, the 5 year survival estimates for overall and cancer specific survival was 100%. We did not identify factors associated with pCR. Conclusions: In this study, pCR was comparable to other larger series reported elsewhere. No factors associated with pCR were identified

  11. Effects of 12 weeks nutrition education on nutritional status in hemodialysis patients

    Directory of Open Access Journals (Sweden)

    Harin Rhee

    2012-06-01

    Full Text Available Protein-energy malnutrition is present in a large proportion of patients with end stage renal disease and, is a strong risk factor for mortality in these patients. This study was aimed to evaluate the effectiveness of 12-weeks nutrition education during the hemodialysis session for the improvement of nutritional status. From the June 2011 to the September 2011, patients who were on regular hemodialysis in Pusan National University Hospital were enrolled in this study. In education group, intensive nutrition education was performed by the hemodialysis nurse, for fifty to sixty minutes during the hemodialysis session, once a week. Curriculum for renal nutrition includes regular taking of their medication, intake of moderate amount of protein and sufficient calories, reduction of water, salt, potassium and phosphate intake. Otherwise, any education program was not performed in patients of control group. Nutrition status was assessed by the subjective global assessment (SGA,body mass index (BMI, triceps skinfold thickness (TSF, arm muscle area(AMC and laboratory markers such as serum albumin, serum blood urea nitrogen(BUN and hemoglobin(Hb level before and after the education. Effect of nutrition education was analyzed using ANCOVA test. A total of 49 patients were enrolled in this study and nutrition education was provided to 25 hemodialysis patients. Their mean age was 57.20±15.49 in education group and 55.13±14.42 in control groupand male was 56.0% in education group and 50.0% in control group and, other baseline characteristics were not significantly different between two groups. After the 12-week education, significant improvement was found in SGA, serum albumin, BUN and Hb level. SGA score was improved from 6.36±0.99 to 6.72±0.61 in education group, compared to control group(6.38±0.88 to 6.42±0.88, p=0.029 . Improvement of serum albumin level, BUN and Hb was as follows: serum albumin(4.23±0.28 to 4.30±0.25 in education group, 4.28±0

  12. Non-operative management of a complete anterior cruciate ligament injury in an English Premier League football player with return to play in less than 8 weeks: applying common sense in the absence of evidence

    Science.gov (United States)

    Weiler, Richard; Monte-Colombo, Mathew; Mitchell, Adam; Haddad, Fares

    2015-01-01

    This case report illustrates and discusses the non-operative management of a complete anterior cruciate ligament (ACL) injury in an English Premier League football player, his return to play within 8 weeks and problem-free follow-up at 18 months post injury. When non-operative verses surgical ACL reconstruction is considered there are many fundamental gaps in our knowledge and currently, at elite level, there are no cases in cutting sports within the literature to guide these decisions. When the norm is for all professional footballers to be recommended surgery, it will be very challenging when circumstances and patient autonomy dictate a conservative approach, where prognosis, end points and risk are unclear and assumed to be high. This case challenges current dogma and provides a starting point for much needed debate about best practice, treatment options, research direction and not just at the elite level of sport. PMID:25917066

  13. Physical comorbidity and 12-week treatment outcomes in Korean patients with depressive disorders: the CRESCEND study.

    Science.gov (United States)

    Kim, Jae-Min; Stewart, Robert; Bae, Kyung-Yeol; Yang, Su-Jin; Yoon, Jin-Sang; Jung, Sung-Won; Lee, Min-Soo; Yim, Hyeon-Woo; Jun, Tae-Youn

    2011-11-01

    Physical and depressive disorders frequently co-occur, but effects of physical health on depression treatment outcomes have received little research. This study aimed to compare treatment outcomes between people with depressive disorder with and without comorbid physical disorders. A Korean nationwide sample of 723 people with depressive disorder initiated on antidepressant treatment, and re-evaluated at 1, 2, 4, 8, and 12 weeks later. Assessment scales for evaluating depressive symptoms (HAMD), anxiety (HAMA), global severity (CGI-s), and functioning (SOFAS) were administered at baseline and every follow-up visit. Achievement of remission or response was defined only when these were maintained to the 12 weeks study endpoint or to the last follow-up examination, if earlier, with the date of the first observed remission point applied as the timing of remission. Logistic regression and Cox proportional hazards models were used. Of the sample, 247 (34%) had at least one physical disorder. This was associated with lower socioeconomic status and more severe depressive symptoms at baseline, but was not associated with any treatment related characteristics including antidepressant type and regimen, concomitant medications, side effects, and duration of treatment period. After adjustment, patients with physical comorbidity responded more slowly and less often - particularly in domains of anxiety, global severity, and functioning (all p-values depressive disorders in people with physical comorbidity. Future comparative studies between conventional and integrated treatment approaches are indicated for depressive disorders with physical comorbidity. 2011 Elsevier Inc. All rights reserved.

  14. Use of a 4-week up-titration regimen of roflumilast in patients with severe COPD

    Directory of Open Access Journals (Sweden)

    Watz H

    2018-03-01

    Full Text Available Henrik Watz,1 Nitin Bagul,2 Klaus F Rabe,3,4 Stephen Rennard,5,6 Vijay KT Alagappan,7 Jonas Román,8 Axel Facius,9 Peter MA Calverley10 1Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; 2DNA Medical Ltd, Langley, UK; 3Department of Pulmonary Medicine, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, 4Department of Medicine, Christian Albrecht University Kiel, Kiel, Germany; 5Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA; 6AstraZeneca, Cambridge, UK; 7AstraZeneca, Gaithersburg, MD, USA; 8AstraZeneca R&D, Gothenburg, Sweden; 9thinkQ2 AG, Baar, Switzerland; 10Department of Clinical Sciences, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK Background: The oral selective phosphodiesterase-4 inhibitor roflumilast (ROF reduces exacerbations in patients with severe COPD. Adverse events (AEs can cause early ROF discontinuation. Alternative dosing strategies may help patients continue their therapy. Methods: In this multicenter, double-blind trial, 1,321 patients with severe COPD were randomized 1:1:1 to 4 weeks’ treatment with ROF 250 µg once daily (OD, 500 µg every other day (EOD, or 500 µg OD, each followed by ROF 500 µg OD for 8 weeks, plus standard therapy. The primary end point was the percentage of patients prematurely discontinuing study treatment. Results: Patients in the 250 µg OD/500 µg OD group had significantly fewer treatment discontinuations (odds ratio [OR] 0.66 [95% CI 0.47–0.93], p=0.017 and lower rates of AEs of interest such as diarrhea, nausea, headache, decreased appetite, insomnia and abdominal pain (OR 0.63 [95% CI 0.47–0.83], p=0.001 compared with those in the 500 µg OD group. Although rates of discontinuation and AEs of interest were numerically lower with ROF 500 µg EOD/500

  15. Persistence of pain in patients with chronic low back pain reported via weekly automated text messages over one year

    DEFF Research Database (Denmark)

    Leboeuf-Yde, Charlotte; Krüger Jensen, Rikke; Wedderkopp, Niels

    2015-01-01

    (Study 1) and the other without any pathological explanation for the pain (Study 2). In both studies, participants were followed over 1 year with weekly automated text messages (SMS-Track). Each week they reported the number of days they had experienced bothersome LBP (0-7 days). The number of weeks......BACKGROUND: A previous study has suggested that it is uncommon for patients with chronic bothersome low back pain (LBP), who consult the secondary health care sector, to report at least four consecutive weeks without such bothersome pain in 1 year. It is not yet known, however, how many days...... of the week they experience pain throughout the year. METHOD: The current study analyzed data collected in two randomized clinical studies conducted in 2007-9 on patients with back pain (Study 1 and 2). Study participants were patients with LBP for more than 2 months, one group with MRI-defined Modic changes...

  16. A comparative study of zoledronic acid and once weekly Alendronate in the management of acute Charcot arthropathy of foot in patients with diabetes mellitus

    Directory of Open Access Journals (Sweden)

    R Bharath

    2013-01-01

    Full Text Available Aim: The aim of this study was to assess and compare the response to two forms of treatment-immobilization with zoledronic acid injection and immobilization with oral weekly Alendronate, in patients with diabetes mellitus and acute Charcot arthropathy (CA of foot in terms of clinical and radiological parameters. Material and Methods: Patients attending the endocrinology and podiatry clinic with history of diabetes mellitus and Acute CA were taken for study. The patients were randomized into two treatment groups. Group Z-zoledronic acid injection along with total contact cast (TCC. Group A-Tab. Alendronate 70 mg. once a week till the complete clinical resolution of acute CA along with TCC. Forty-five patients were randomized and 40 of them completed the study. The primary end point was complete clinical resolution of acute CA-defined as temperature difference between normal and affected foot <1oF. Results: Among the 40 patients, 30 (75% had complete clinical resolution. The mean number of days taken for complete clinical resolution since the initiation of treatment (either Zoledronic acid or Alendronate was approximately 122 days. There was no significant difference in a number of days required for complete clinical resolution, between the two forms of therapy. There was more than 50% reduction in the visual score between the baseline and the final scan. The target to non-target ratio in the skeletal phase also showed an average of 40% reduction from the baseline to the final skeletal scintigraphy. Conclusion: Both Intravenous Zoledronic acid and oral alendronate had comparable efficacy with respect to the time taken for attaining complete clinical resolution of acute CA of foot. However, Alendronate therapy was cost effective among the two. 99m Tc MDP bone scan can be used as an adjuvant to the clinical parameters in assessing the response to therapy.

  17. The effect of weekly specialist palliative care teleconsultations in patients with advanced cancer -a randomized clinical trial.

    NARCIS (Netherlands)

    Hoek, P.D.; Schers, H.J.; Bronkhorst, E.M.; Vissers, K.C.P.; Hasselaar, J.G.J.

    2017-01-01

    BACKGROUND: Teleconsultation seems to be a promising intervention for providing palliative care to home-dwelling patients; however, its effect on clinically relevant outcome measures remains largely unexplored. Therefore, the purpose of this study was to determine whether weekly teleconsultations

  18. 636 ART-naive patients were enrolled; 361 completed 6 months of ...

    Indian Academy of Sciences (India)

    First page Back Continue Last page Graphics. 636 ART-naive patients were enrolled; 361 completed 6 months of follow-up (282 received supplements and 79 received standard care). 636 ART-naive patients were enrolled; 361 completed 6 months of follow-up (282 received supplements and 79 received standard care).

  19. Effects of a 12-week exercise training on insulin sensitivity, quality of life, and depression status in patients with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Chia-Huei Lin

    2017-01-01

    Full Text Available Background: Exercise is one of the optimal and alternative treatments for type 2 diabetes (T2DM. Although the effect of a single bout of exercise on insulin sensitivity is reported to persist only for 2–3 days, effects remain unclear of a 12-week aerobic exercise training on insulin sensitivity, quality of life (QOL, and depression status over time as exercise training duration increases in patients with T2DM. Objectives: To investigate the effects over time in patients with T2DM of a 12-week aerobic exercise training on insulin sensitivity, QOL, and depression status. Materials and Methods: Purposive sampling was used to recruit 17 T2DM patients. Participants underwent a 12-week, supervised, moderate-intensity aerobic exercise training three times per week, 30 min per session. Outcome indicators including insulin sensitivity (measured by a 2-h oral glucose tolerance test [OGTT] and homeostatic model assessment-insulin resistance [HOMA-IR], QOL (Medical Outcomes Study Short Form 36, and depression status (beck depression inventory scale were evaluated at baseline and at 4-week intervals. Results: A final 13 eligible participants completed the study. For every 4-week increase in duration of exercise training, there was an increase over time in insulin sensitivity, including a decrease over time in OGTT glucose area under the curve of 66.92 min/mmol/L. Glucose concentrations decreased over time at 60, 90, and 120 min after an oral glucose challenge. Further, the HOMA-IR decreased over time as the duration of exercise training increased. QOL and depression status improved significantly during the training. Conclusions: Moderate-intensity exercise training improves insulin sensitivity, QOL, and depression status in T2DM patients, particularly over time within a 12-week exercise training course.

  20. Efficacy and safety of once-weekly intravenous epoetin alfa in maintaining hemoglobin levels in hemodialysis patients.

    Science.gov (United States)

    Locatelli, Francesco; Villa, Giuseppe; Messa, Piergiorgio; Filippini, Armando; Cannella, Giuseppe; De Ferrari, Giacomo; Naso, Agostino; Rossi, Egidio; Formica, Marco; Lombardi, Luigi; Rotolo, Ugo; Conte, Feruccio

    2008-01-01

    Although an erythropoiesis-stimulating agent (ESA) is most frequently administered intravenously for treatment of anemia in patients with chronic kidney disease who are on dialysis, few studies have compared the efficacy of different intravenous (i.v.) dosing schedules. This multicenter, phase IIIb, open-label, controlled study randomized 289 stable hemodialysis patients to continue with conventional dosing of i.v. epoetin alfa or darbepoetin, or to switch to once-weekly i.v. epoetin alfa at the same cumulative weekly starting dose, to maintain hemoglobin levels at 11.0-13.0 g/dL, and within 1.0 g/dL of the baseline value. Hemoglobin levels and ESA doses were recorded every 4 weeks for 28 weeks. Hemoglobin levels fell significantly and ESA doses increased significantly between baseline and week 28 (mean of week 16-28 values) in the once-weekly epoetin alfa group, compared with the conventional treatment group (phemoglobin levels between the groups was 0.73 g/dL (greater than the threshold for therapeutic equivalence of 0.5 g/dL). The changes between groups from baseline was significant at all time points for hemoglobin levels (0.36, 0.46, 0.81, 0.87, 0.78, 0.62 and 0.49 g/dL) and from week 12 for ESA dose (718.5, 1,326.5, 1,732.0, 1,839.7 and 1,959.1 IU/week; p=0.005). Hemoglobin was maintained at the target level in 78% and 84% of patients on conventional dosing, and 67% and 64% of those on once-weekly epoetin alfa in the intention-to-treat (p=0.1) and per protocol (p=0.016) populations, respectively. This study did not show therapeutic equivalence of once-weekly i.v. epoetin alfa with conventional dosing regimens.

  1. Phase I study of twice-weekly gemcitabine and concomitant external-beam radiotherapy in patients with adenocarcinoma of the pancreas

    International Nuclear Information System (INIS)

    Pipas, J. Marc; Mitchell, Sandra E.; Barth, Richard J.; Vera-Gimon, Raul; Rathmann, Joerg; Meyer, Louise P.; Wagman, Richard S.; Lewis, Lionel D.; McDonnell, Carol; Colacchio, Thomas A.; Perez, Raymond P.

    2001-01-01

    Purpose: To determine the maximum tolerated dose and dose-limiting toxicity associated with twice-weekly gemcitabine and concomitant external-beam radiotherapy in patients with adenocarcinoma of the pancreas. Methods and Materials: Twenty-one patients with biopsy-proven adenocarcinoma of the pancreas were treated with external-beam radiotherapy to a dose of 50.4 Gy in 28 fractions, concurrent with gemcitabine, infused over 30 min before irradiation on a Monday and Thursday schedule. The dose of gemcitabine was escalated in 5 cohorts of 3-6 patients each. Initial gemcitabine dose was 10 mg/m 2 , with dose escalation until dose-limiting toxicity was observed. Results: The maximum tolerated dose of gemcitabine was 50 mg/m 2 , when given in a twice-weekly schedule with radiation. Dose-limiting toxicity was seen in 2 patients at 60 mg/m 2 , and consisted of severe upper gastrointestinal bleeding approximately 1 month after completion of treatment. Six patients had radiographic evidence of response to treatment, and 5 of these underwent complete surgical resection. Three patients who underwent complete resection had been deemed to have unresectable tumors before enrollment on trial. Four patients are alive, including 2 without evidence of disease more than 1 year after resection. Conclusion: The combination of external-beam radiation and twice-weekly gemcitabine at a dose of 50 mg/m 2 is well tolerated and shows promising activity for the treatment of pancreatic cancer. Our data suggest a higher maximum tolerated dose and different dose-limiting toxicity than previously reported. Further investigation of this regimen is warranted

  2. Natural killer cells activity in a metastatic colorectal cancer patient with complete and long lasting response to therapy.

    Science.gov (United States)

    Ottaiano, Alessandro; Napolitano, Maria; Capozzi, Monica; Tafuto, Salvatore; Avallone, Antonio; Scala, Stefania

    2017-11-16

    Here we report a case of a 70-year-old man who received adjuvant chemotherapy with fluorouracile, folinic acid and oxaliplatin after a left hemicolectomy for a stage IIIb adenocarcinoma in May 2009. During follow-up he de-veloped abdominal lymphnodes metastases evidenced by positron emission tomography- computed tomography (PET-CT) scan and increase of carcinoembryonic antigen (CEA) level. Chemotherapy with capecitabine, oxaliplatin and bevacizumab was started in April 2012. Restaging showed a complete response and normalization of CEA. The patient received maintenance therapy with bevacizumab which was stopped in December 2013 for patient choice. In October 2014, a new increase in CEA was documented and PET-CT scan showed lung metastases. Analysis of RAS status revealed the absence of mutations, then the patient started a second-line chemotherapy with fluorouracile, folinic acid, irinotecan (folfiri) and panitumumab achieving, in January 2015, a complete response and normalization of CEA. Thereafter, folfiri was discontinued for toxicity; furthermore, upon the third occurrence of a grade 3 dermatologic toxicity, panitumumab was continued from June 2015 at 60% of the original dose and it was administered every three weeks. Until presentation of this case, the patient maintains a complete response, has no symptoms of disease and CEA is normal. Interestingly, this patient presented a high proportion of circulating natural killer (NK) cells (35.1%) with high cytotoxic activity against tumor cells. Study on the role of NK in patients with advanced colorectal cancer are ongoing.

  3. A 64-week, multicenter, open-label study of aripiprazole effectiveness in the management of patients with schizophrenia or schizoaffective disorder in a general psychiatric outpatient setting

    Directory of Open Access Journals (Sweden)

    Chiu Nan-Ying

    2010-09-01

    Full Text Available Abstract Objective To evaluate the overall long-term effectiveness of aripiprazole in patients with schizophrenia in a general psychiatric practice setting in Taiwan. Methods This was a prospective, open-label, multicenter, post-market surveillance study in Taiwanese patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV diagnosis of schizophrenia or schizoaffective disorder requiring a switch in antipsychotic medication because current medication was not well tolerated and/or clinical symptoms were not well controlled. Eligible patients were titrated to aripiprazole (5-30 mg/day over a 12-week switching phase, during which their previous medication was discontinued. Patients could then enter a 52-week, long-term treatment phase. Aripiprazole was flexibly dosed (5-30 mg/day at the discretion of the treating physicians. Efficacy was assessed using the Clinical Global Impression scale Improvement (CGI-I score, the Clinical Global Impression scale Severity (CGI-S score, The Brief Psychiatry Rating Scale (BPRS, and the Quality of Life (QOL scale, as well as Preference of Medicine (POM ratings by patients and caregivers. Safety and tolerability were also assessed. Results A total of 245 patients were enrolled and switched from their prior antipsychotic medications, and 153 patients entered the 52-week extension phase. In all, 79 patients (32.2% completed the study. At week 64, the mean CGI-I score was 3.10 and 64.6% of patients who showed response. Compared to baseline, scores of CGI-S, QOL, and BPRS after 64 weeks of treatment also showed significant improvements. At week 12, 65.4% of subjects and 58.9% of caregivers rated aripiprazole as better than the prestudy medication on the POM. The most frequently reported adverse events (AEs were headache, auditory hallucinations and insomnia. A total of 13 patients (5.3% discontinued treatment due to AEs. No statistically significant changes were noted with respect to

  4. Perceived behavioral control as a potential precursor of walking three times a week: Patient's perspectives

    Science.gov (United States)

    Busse, Peter

    2018-01-01

    Background Behavior change theories can identify people’s main motivations to engage in recommended health practices and thus provide better tools to design interventions, particularly human centered design interventions. Objectives This study had two objectives: (a) to identify salient beliefs about walking three times a week for 30 minutes nonstop among patients with hypertension in a low-resource setting and, (b) to measure the relationships among intentions, attitudes, perceived social pressure and perceived behavioral control about this behavior. Methods Face-to-face interviews with 34 people living with hypertension were conducted in September-October 2011 in Lima, Peru, and data analysis was performed in 2015. The Reasoned Action Approach was used to study the people’s decisions to walk. We elicited people’s salient beliefs and measured the theoretical constructs associated with this behavior. Results Results pointed at salient key behavioral, normative and control beliefs. In particular, perceived behavioral control appeared as an important determinant of walking and a small set of control beliefs were identified as potential targets of health communication campaigns, including (not) having someone to walk with, having work or responsibilities, or having no time. Conclusions This theory-based study with a focus on end-users provides elements to inform the design of an intervention that would motivate people living with hypertension to walk on a regular basis in low-resource settings. PMID:29451917

  5. Retrospective cohort study of all deaths among infants born between 22 and 27 completed weeks of gestation in Switzerland over a 3-year period.

    Science.gov (United States)

    Berger, T M; Steurer, M A; Bucher, H U; Fauchère, J C; Adams, M; Pfister, R E; Baumann-Hölzle, R; Bassler, D

    2017-06-15

    The aim of this research is to assess causes and circumstances of deaths in extremely low gestational age neonates (ELGANs) born in Switzerland over a 3-year period. Population-based, retrospective cohort study. All nine level III perinatal centres (neonatal intensive care units (NICUs) and affiliated obstetrical services) in Switzerland. ELGANs with a gestational age (GA) Switzerland, most deaths among infants born at less than 24 weeks of gestation occurred in the delivery room. In contrast, most deaths of ELGANs with a GA ≥24 weeks were observed following unrestricted provisional intensive care, end-of-life decision-making and redirection of care in the NICU regardless of the degree of immaturity. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  6. The effects of weekly augmentation therapy in patients with PiZZ α1-antitrypsin deficiency

    Directory of Open Access Journals (Sweden)

    Schmid ST

    2012-09-01

    Full Text Available ST Schmid,1 J Koepke,1 M Dresel,1 A Hattesohl,1 E Frenzel,2 J Perez,3 DA Lomas,4 E Miranda,5 T Greulich,1 S Noeske,1 M Wencker,6 H Teschler,6 C Vogelmeier,1 S Janciauskiene,2,* AR Koczulla1,*1Department of Internal Medicine, Division for Pulmonary Diseases, University Hospital Marburg, Marburg, Germany; 2Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany; 3Department of Cellular Biology, University of Malaga, Malaga, Spain; 4Department of Medicine, Cambridge Institute for Medical Research, University of Cambridge, Cambridge, United Kingdom; 5Department of Biology and Biotechnology, Istituto Pasteur – Fondazione Cenci Bolognetti, Sapienza University of Rome, Rome, Italy; 6Department of Pneumology, West German Lung Clinic, Essen University Hospital, Essen, Germany*These authors contributed equally to this workBackground: The major concept behind augmentation therapy with human α1-antitrypsin (AAT is to raise the levels of AAT in patients with protease inhibitor phenotype ZZ (Glu342Lys-inherited AAT deficiency and to protect lung tissues from proteolysis and progression of emphysema.Objective: To evaluate the short-term effects of augmentation therapy (Prolastin® on plasma levels of AAT, C-reactive protein, and chemokines/cytokines.Materials and methods: Serum and exhaled breath condensate were collected from individuals with protease inhibitor phenotype ZZ AAT deficiency-related emphysema (n = 12 on the first, third, and seventh day after the infusion of intravenous Prolastin. Concentrations of total and polymeric AAT, interleukin-8 (IL-8, monocyte chemotactic protein-1, IL-6, tumor necrosis factor-α, vascular endothelial growth factor, and C-reactive protein were determined. Blood neutrophils and primary epithelial cells were also exposed to Prolastin (1 mg/mL.Results: There were significant fluctuations in serum (but not in exhaled breath condensate levels of AAT polymers, IL-8, monocyte chemotactic protein-1, IL

  7. Ten weeks of home-based exercise attenuates symptoms of chemotherapy-induced peripheral neuropathy in breast cancer patients

    Directory of Open Access Journals (Sweden)

    Karen Y. Wonders

    2013-09-01

    Full Text Available The purpose of this investigation was to determine if a structured, home-based exercise program was beneficial to reduce symptoms of chemotherapy-induced peripheral neuropathy and improve quality of life (QOL. A total of 50 women who are breast cancer survivors and are listed in the Breast Cancer Registry of Greater Cincinnati database were recruited by mail. Participants were initially asked to complete the McGill QOL questionnaire and the Leeds Assessment of Neuropathic Symptoms and Signs, before beginning a 10-week home-based exercise program. At the completion of the exercise program, subjects were asked again to complete the same two questionnaires. Pre- and post-intervention data were analyzed using a repeated measures ANOVA, at a significance level of α<0.05. Six individuals completed the investigation. Prior to the 10-week exercise program, participants described their pain as unpleasant skin sensations (Pre-HBEx, N=6, abnormally sensitive to touch (Pre-HBEx, N=6, and coming on suddenly in bursts for no apparent reason (Pre-HBEx, N=5. Following 10-weeks of exercise, participants reported experiencing less of these symptoms (Post- HBEx, N=3, 1, and 4 respectively; P=0.05. It was also determined that troublesome symp- toms were significantly reduced after 10- weeks of home-based exercise (P=0.05.

  8. The influence of bacterial vaginosis on gestational week of the completion of delivery and biochemical markers of inflammation in the serum

    Directory of Open Access Journals (Sweden)

    Jakovljević Ana

    2014-01-01

    Full Text Available Bacground/Aim. Preterm delivery is one of the most common complications in pregnancy, and it is the major cause (75- 80% of all neonatal deaths. Bacterial vaginosis predisposes to an increased risk of preterm delivery, premature rupture of membrane and miscarriage. In this syndrome normal vaginal lactobacilli, which produce protective H2O2, are reduced and replaced with anaerobic, gram-negative bacteria and others. The aim of this study was to evaluate the influence of bacterial vaginosis on the week of delivery and biochemical markers of inflammation in the serum. Methods. A total of 186 pregnant women were included into this study, between the week 16 and 19 of pregnancy. In the study group there were 76 pregnant women with diagnosed bacterial vaginosis by the criteria based on vaginal Gram-stain Nugent score and Amsel criteria. In the control group there were 110 healthy women with normal vaginal flora. Ultrasound examination was performed in both groups. Vaginal fluid and blood samples were taken to determine biochemical markers with colorimetric methods. Results. The week of delivery was statistically significantly shorter in the study group and the levels of biochemical markers of inflammation (C-reactive protein and fibrinogen in the serum were statistically significantly higher in women with bacterial vaginosis comparing to the control group. Also the levels of uric acid and white blood cells in the serum were higher in the study group compared to the control one. Conclusion. Our study indicates that the pregnancy complicated with bacterial vaginosis ends much earlier than the pregnancy without it. Also, higher levels of biochemical markers of inflammation in the serum in the study group, similarly to results of other studies, suggest that pathophysiological processes responsible for preterm delivery can begin very early in pregnancy.

  9. Virological response and safety of 24-week telaprevir alone in Japanese patients infected with hepatitis C virus subtype 1b

    Science.gov (United States)

    Toyota, J; Ozeki, I; Karino, Y; Asahina, Y; Izumi, N; Takahashi, S; Kawakami, Y; Chayama, K; Kamiya, N; Aoki, K; Yamada, I; Suzuki, Y; Suzuki, F; Kumada, H

    2013-01-01

    Hepatitis C virus (HCV) subtype 1b, which infects approximately 70% of Japanese carriers, is likely to be more eradicable by a telaprevir regimen than subtype 1a because of the higher genetic barrier of Val36 and Arg155 substitutions. The aims of this exploratory study were to evaluate the virological response and safety of 24-week oral administration of telaprevir alone in chronic HCV subtype 1b infection. Fifteen treatment-naïve patients were treated with telaprevir 750 mg every 8 h for 24 weeks. All patients were Japanese whose median age was 58.0 years (range: 45–68), and six patients (40%) were men. Median baseline HCV RNA level was 6.80 log10 IU/mL (range: 3.55–7.10). The HCV RNA levels decreased to undetectable in five patients (33%) within 8 weeks. Three patients (20%) with negative HCV RNA by Week 4 achieved end of treatment response. One patient (7%) who achieved sustained virological response had a low baseline viraemia of 3.55 log10 IU/mL. Most of the adverse events including anaemia and skin disorders were mild to moderate. Developed variants were T54A and A156V/T/F/Y with or without secondary substitutions rather than V36M ± R155K. Telaprevir alone for 24 weeks in Japanese patients with HCV subtype 1b resulted in an sustained viral response rate of 7% (1/15) and was well tolerated for 24 weeks. These results will support the implementation of further studies on oral combination of telaprevir with other direct-acting antiviral agents in patients infected with HCV subtype 1b. PMID:23383655

  10. Expectations and final evaluation of complete dentures by patients, dentist and dental technician.

    Science.gov (United States)

    Marachlioglou, C R M Z; Dos Santos, J F F; Cunha, V P P; Marchini, Leonardo

    2010-07-01

    There is a poor association between the dentist's evaluation of denture quality and patients' satisfaction with their dentures. Possible differences between dental professionals and patients' expectations might help explain differences in outcome evaluations. This study compared scores given by a dentist, a dental technician and patients for their expectations before and their final evaluation after complete dentures treatment. Twenty completely edentulous patients, a prosthodontist and a dental technician provided scores for the expected aesthetic and functional results of their dentures based on a visual analogue scale at baseline. Post-treatment completion ratings were given after adjustments, by dentist and patients. The dental technician provided post-treatment completion ratings after completing the dentures. The patients had higher expectations than the dental technician and the dentist perceived for both aesthetic and function (P < 0.001). The patients also presented higher post-treatment completion ratings than the dental professionals perceived for final aesthetics (P = 0.016, Kendall's W = 0.207) and function (P = 0.002, Kendall's W = 0.303). Only the dentist presented a statistically significant difference between expectations (lower) and final (higher) outcomes for aesthetics (P = 0.017) and function (P = 0.003). There was no correlation between expectations and post-treatment completion ratings according to the patients' age. There was also no correlation between the patients' gender and expectation scores. Patients presented higher expectations regarding their dentures than dental professionals. The dentist believed that dentures would bring fewer benefits than patients did, but his perception of denture benefits post-treatment was significantly higher than his expectations.

  11. A randomized controlled trial of 6-week Chlorella vulgaris supplementation in patients with major depressive disorder.

    Science.gov (United States)

    Panahi, Yunes; Badeli, Roghayeh; Karami, Gholam-Reza; Badeli, Zeinab; Sahebkar, Amirhossein

    2015-08-01

    Major depressive disorder (MDD) is a widespread psychiatric disorder with incapacitating symptoms. Oxidative stress has been identified to play a role in the pathophysiology of MDD. To evaluate the therapeutic effectiveness of a chemically defined and antioxidant-rich Chlorella vulgaris extract (CVE) as adjunct to standard treatment in patients suffering from MDD. Subjects with MDD diagnosis according to DSM-IV criteria who were receiving standard antidepressant therapy were assigned to add-on therapy with CVE (1800 mg/day; n=42), or continued standard antidepressant therapy alone (n=50) for a period of 6 weeks. Changes in the frequency of depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS) and Beck Depression Inventory II (BDI-II) scale. There were significant reductions in total and subscale BDI-II and HADS scores in both CVE and control groups by the end of trial. The magnitude of reductions in total BDI-II score [-4.14 (-5.30 to -2.97)] as well as physical [-2.34 (-2.84 to -1.84)] and cognitive [-1.12 (-1.62 to -0.61)] subscales were significantly greater in the CVE versus control group, however, reduction of the affective symptoms was greater in the control compared with the CVE group [0.95 (0.18-0.72)]. Total HADS [-3.71 (-4.44 to -2.98)] as well as individual subscales of depression [-1.46 (-2.02 to -0.90)] and anxiety [-2.25 (-2.74 to -1.76)] were reduced to a greater degree in the CVE group. CVE was well tolerated and no serious adverse event was reported. This pilot exploratory trial provides the first clinical evidence on the efficacy and safety of adjunctive therapy with CVE in improving physical and cognitive symptoms of depression as well as anxiety symptoms in patients who are receiving standard antidepressant therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. Ovarian carcinoma: improved survival following abdominopelvic irradiation in patients with a completed pelvic operation

    International Nuclear Information System (INIS)

    Dembo, A.J.; Bush, R.S.; Beale, F.A.; Bean, H.A.; Pringle, J.F.; Sturgeon, J.; Reid, J.G.

    1979-01-01

    A prospective, stratified, randomized study of 190 postoperative ovarian carcinoma patients with Stages IB, II, and III (asymptomatic) presentations is reported. The median time of follow-up was 52 months. Patients in whom bilateral salpingo-oophorectomy and hysterectomy (BSOH) could not be completed because of extensive pelvic tumor had a poor prognosis which did not differ for any of the therapies tested. When BSOH was completed, pelvic plus abdominopelvic irradiation (P + AB) with no diaphragmatic shielding significantly improved patient survival rate and long-term control of occult upper abdominal disease in approximately 25% more patients than pelvic irradiation alone or followed by adjuvant daily chlorambucil therapy. The effectiveness of P + AB in BSOH-completed patients was independent of stage or tumor grade and was most clearly appreciated in patients with all gross tumor removed. Chlorambucil added to pelvic irradiation delayed the time to treatment failure without reducing the number of treatment failures

  13. Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis.

    Science.gov (United States)

    Iwamoto, Naoki; Tsuji, Sosuke; Takatani, Ayuko; Shimizu, Toshimasa; Fukui, Shoichi; Umeda, Masataka; Nishino, Ayako; Horai, Yoshiro; Koga, Tomohiro; Kawashiri, Shin-Ya; Aramaki, Toshiyuki; Ichinose, Kunihiro; Hirai, Yasuko; Tamai, Mami; Nakamura, Hideki; Terada, Kaoru; Origuchi, Tomoki; Eguchi, Katsumi; Ueki, Yukitaka; Kawakami, Atsushi

    2017-01-01

    We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA) in a real-world setting. Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS)28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs) were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks. Fifty-eight patients (82.9%) continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (Ptofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX) or patients whose treatment with tocilizumab (TCZ) failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs) previously used was independently associated with achievement of DAS-low disease activity. Our present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.

  14. Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis.

    Directory of Open Access Journals (Sweden)

    Naoki Iwamoto

    Full Text Available We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA in a real-world setting.Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks.Fifty-eight patients (82.9% continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (P<0.0001, vs. baseline. 15 AEs including 5 herpes zoster infection occurred during tofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX or patients whose treatment with tocilizumab (TCZ failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs previously used was independently associated with achievement of DAS-low disease activity.Our present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.

  15. STRATEGIES OF COMPLETE ORAL REHABILITATION IN PATIENTS WITH DISFUNCTIONAL SYNDROM OF THE STOMATOGNATE SYSTEM

    Directory of Open Access Journals (Sweden)

    Vasile BURLUI

    2015-12-01

    Full Text Available The complete oral and dental rehabilitation (ROC or (CODR requires an advanced understanding level, based on the capacity to prepare and successfully fix the complete strategy for the complex oral rehabilitation had in view.The method applied was to subject a representative group of patients to the algorithm of diagnosis and clinical solution. The strategies of complete oral rehabilitation applied included surgical-periodontal, implanto-surgical, implanto-prosthetic rehabilitation techniques.

  16. Weekly Gemcitabine and Cisplatin in Combination With Radiotherapy in Patients With Locally Advanced Head-and-Neck Cancer: Phase I Study

    Energy Technology Data Exchange (ETDEWEB)

    Arruda Viani, Gustavo, E-mail: gusviani@gmail.com [Radiation Oncology Department, Faculty of Medicine of Marilia, Sao Paulo (Brazil); Afonso, Sergio Luis [Clinical Oncology Department, Faculty of Medicine of Marilia, Sao Paulo (Brazil); Cardoso Tavares, Vivian [Head and Neck Oncology Department, Faculty of Medicine of Marilia, Sao Paulo (Brazil); Bernardes Godoi da Silva, Lucas; Stefano, Eduardo Jose [Radiation Oncology Department, Faculty of Medicine of Marilia, Sao Paulo (Brazil)

    2011-11-15

    Purpose: To define the maximum tolerated dose by describing the dose-limiting toxicity (DLT) of weekly gemcitabine and cisplatin in patients with locally advanced head-and-neck (LAHN) cancer concomitant to irradiation. Methods and Materials: Patients with LAHN cancer were enrolled in a prospective, dose-escalation Phase I study. Toxicity was graded according to the Common Toxicity Criteria score. Maximum tolerated dose was defined when DLT developed in 2 of 6 patients. The starting dose of cisplatin was 20 mg/m{sup 2} and that of gemcitabine was 10 mg/m{sup 2} in 3 patients, with a subsequent dose escalation of 10 mg/m{sup 2} of cisplatin only for 3 new patients. In the next levels, only a dose escalation of gemcitabine with 10 mg/m{sup 2} for each new cohort was used (Level 1, 10 mg/m{sup 2} of gemcitabine and 20 mg/m{sup 2} of cisplatin; Level 2, 10 mg/m{sup 2} of gemcitabine and 30 mg/m{sup 2} of cisplatin; and Level 3, 20 mg/m{sup 2} of gemcitabine and 30 mg/m{sup 2} of cisplatin). Radiation therapy was administered by use of a conformal technique over a period of 6 to 7 weeks in 2.0-Gy daily fractions for 5 consecutive days per week to a total dose of 70 Gy. Results: From 2008 to 2009, 12 patients completing 3 dose levels were included in the study. At Dose Level 3, 1 of 3 patients had DLT with Grade 3 mucositis. Of the next 3 required patients, 2 showed DLT with Grade 3 dermatitis. At a follow-up of 3 months, 10 of 12 evaluable patients (83.3%) obtained a complete response and 1 patient (8.3%) obtained a partial response. Among the complete responders, at a median follow-up of 10 months (range, 6-14 months), 9 patients are alive and disease free. Conclusion: Gemcitabine at low doses combined with cisplatin is a potent radiosensitizer effective in patients with LAHN cancer. The recommended Phase II dose is 10 mg/m{sup 2} of gemcitabine and 30 mg/m{sup 2} of cisplatin with an acceptable tolerability profile.

  17. Low Completeness of Bacteraemia Registration in the Danish National Patient Registry

    DEFF Research Database (Denmark)

    Gradel, Kim Oren; Nielsen, Stig Lønberg; Pedersen, Court

    2015-01-01

    Bacteraemia is associated with significant morbidity and mortality and timely access to relia-ble information is essential for health care administrators. Therefore, we investigated the complete-ness of bacteraemia registration in the Danish National Patient Registry (DNPR) containing hospital...... according to the International Classification of Diseases, version 10, and surgical procedure codes were retrieved from the DNPR. The codes were categorized into seven groups, ranked a priori according to the likelihood of bacteraemia. Completeness was analysed by contin-gency tables, for all patients...

  18. Renal AA amyloidosis in a patient with hereditary complete complement C4 deficiency

    Directory of Open Access Journals (Sweden)

    Imed Helal

    2011-01-01

    Full Text Available Hereditary complete C4 deficiency has until now been reported in 30 cases only. A disturbed clearance of immune- complexes probably predisposes these individuals to systemic lupus erythematosus, other immune- complex diseases and recurrent microbial infections. We present here a 20- year- old female with hereditary complete C4 deficiency. Renal biopsy demonstrated renal AA amyloidosis. This unique case further substantiates that deficiency of classical pathway components predisposes to the development of recurrent microbial infections and that the patients may develop AA amyloidosis. Furthermore, in clinical practice, the nephrotic syndrome occurring in a patient with hereditary complete complement C4 deficiency should lead to the suspicion of renal AA amyloidosis.

  19. The Effects of 10 Weeks Concurrent Aerobic and Strength Exercise on Quality of Life and Resilience of Kidney Transplant Patients

    Directory of Open Access Journals (Sweden)

    Elham Shakoor

    2015-09-01

    Full Text Available Background: Kidney transplant patients are exposed to a lot of different infectious on diseases because of long usage of suppressing immune system drugs.  Quality of life (QoL is generally found to improve for renal transplant recipients, although some patients continue to experience health-related problems. Kidney transplant is the selected treatment of chronic kidney disease and it improves life quality and resilience. Objective: To evaluate The Effects of 10 Weeks Concurrent Aerobic and Strength Exercise on Quality of Life and Resilience of Kidney Transplant Patients. Methods: forty four renal transplant recipients were selected to participate in the study and randomized into exercise (n=29 and control (n=15 groups. The exercise group participated in a cumulative exercise pro¬gram 3 days a week for 10 weeks in 60–90-minute exercise sessions. Control group subjects did not participate in any regular exercise activity during this period. For measuring the variable of this research; the resilience scale of Cano and Davidson (2003 and questionnaire which measured quality of life (SF-36 measured before and after 10 weeks of exercise training. Data analysis was conducted using t-tests. Results: quality of life and resilience values were significantly increased after 10 weeks of exercise training in the exercise group relative to control (P<0.05. Conclusion: ten weeks of selected low-intensity exercise can be an effective measure to improve the quality of life and resilience in renal transplant patients. Keywords: Concurrent, Aerobic and Strength Exercise, Quality of Life, Resilience, Kidney Transplant Patients

  20. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks.

    Science.gov (United States)

    Blonde, Lawrence; Stenlöf, Kaj; Fung, Albert; Xie, John; Canovatchel, William; Meininger, Gary

    2016-05-01

    Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, has been associated with weight loss in a broad range of patients with type 2 diabetes mellitus (T2DM). This analysis further evaluated changes in body weight and composition with canagliflozin in two 104-week, Phase 3 studies. In Study 1, patients aged 18-80 years (N = 1,450) received canagliflozin 100 or 300 mg or glimepiride as add-on to metformin for a 52-week core treatment period, followed by a 52-week extension period. In Study 2, patients aged 55-80 years (N = 714) received canagliflozin 100 or 300 mg or placebo added to stable background antihyperglycemic agents for a 26-week core treatment period, followed by a 78-week extension period. Percent change from baseline in body weight; proportion of patients with any weight loss, ≥5% weight loss, and ≥10% weight loss; change in body mass index (BMI) and waist circumference; change in body weight across weight-loss quartiles; and changes in body composition were evaluated in both studies. Canagliflozin 100 and 300 mg provided sustained weight loss versus either glimepiride or placebo over 104 weeks. More patients experienced any weight loss and ≥5% weight loss with canagliflozin versus comparator. Across the 3 highest weight-loss quartiles, canagliflozin provided greater weight loss versus glimepiride or placebo. BMI and waist circumference reductions were observed with canagliflozin 100 and 300 mg versus either glimepiride or placebo over 104 weeks; more patients had BMI or waist circumference reductions with canagliflozin versus comparator. Body composition analysis indicated that the majority of weight loss was due to loss of fat mass. Canagliflozin was generally well tolerated, with increased incidence of adverse events related to the SGLT2 inhibition mechanism. Canagliflozin 100 and 300 mg provided sustained reductions in body weight, BMI, and waist circumference in a greater proportion of patients with T2DM versus

  1. Clinical strategies for complete denture rehabilitation in a patient with Parkinson disease and reduced neuromuscular control.

    Science.gov (United States)

    Haralur, Satheesh B

    2015-01-01

    The dentist has a large role in geriatric health care for the ever increasing elder population with associated physical and neurological disorders. The Parkinson disease is progressive neurological disorder with resting tremor, bradykinesia, akinesia, and postural instability. The psychological components of disease include depression, anxiety, and cognitive deficiency. Poor oral hygiene, increased susceptibility for dental caries, and periodontal diseases predispose them to early edentulism. The number of Parkinson affected patients visiting dental clinic seeking complete denture is growing. This case report explains the steps involved in the complete denture rehabilitation of Parkinson patient. The effective prosthesis will help in alleviating functional, aesthetic, and psychological disabilities of the patient.

  2. Clinical Strategies for Complete Denture Rehabilitation in a Patient with Parkinson Disease and Reduced Neuromuscular Control

    Directory of Open Access Journals (Sweden)

    Satheesh B. Haralur

    2015-01-01

    Full Text Available The dentist has a large role in geriatric health care for the ever increasing elder population with associated physical and neurological disorders. The Parkinson disease is progressive neurological disorder with resting tremor, bradykinesia, akinesia, and postural instability. The psychological components of disease include depression, anxiety, and cognitive deficiency. Poor oral hygiene, increased susceptibility for dental caries, and periodontal diseases predispose them to early edentulism. The number of Parkinson affected patients visiting dental clinic seeking complete denture is growing. This case report explains the steps involved in the complete denture rehabilitation of Parkinson patient. The effective prosthesis will help in alleviating functional, aesthetic, and psychological disabilities of the patient.

  3. Darbepoetin alfa once every 2 weeks for treatment of anemia in dialysis patients

    DEFF Research Database (Denmark)

    Mann, J; Kessler, M; Villa, Giulio Palludan

    2007-01-01

    AIM: Darbepoetin alfa has a longer half-life than epoetin-(EPO) alfa or beta, allowing administration at less frequent intervals for the treatment of renal anemia. The aim of the present analysis was to evaluate the efficacy and tolerability of an every-2-week (Q2W) schedule of darbepoetin alfa...

  4. Aripiprazole plus topiramate in opioid-dependent patients with schizoaffective disorder: an 8-week, open-label, uncontrolled, preliminary study.

    Science.gov (United States)

    Bruno, Antonio; Romeo, Vincenzo M; Pandolfo, Gianluca; Scimeca, Giuseppe; Zoccali, Rocco A; Muscatello, Maria Rosaria A

    2014-01-01

    The aims of this study were to evaluate a combination of aripiprazole and topiramate in the treatment of opioid-dependent patients with schizoaffective disorder undergoing methadone maintenance therapy (MMT) and, further, to taper off patients from methadone treatment. Twenty patients who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for opioid dependence and schizoaffective disorder receiving MMT (80 mg/day) were given aripiprazole (10 mg/day) plus topiramate (up to 200 mg/day) for 8 weeks. A methadone dose reduction of 3 mg/day until suspension at week 4 was established. Aripiprazole plus topiramate was effective in reducing clinical symptoms, and a rapid tapering off of MMT was achieved. Combining aripiprazole and topiramate may be effective in patients with a dual diagnosis of opioid dependency and schizoaffective disorder.

  5. Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study.

    Science.gov (United States)

    van der Heijde, Désirée; Deodhar, Atul; Wei, James C; Drescher, Edit; Fleishaker, Dona; Hendrikx, Thijs; Li, David; Menon, Sujatha; Kanik, Keith S

    2017-08-01

    To compare efficacy and safety of various doses of tofacitinib, an oral Janus kinase inhibitor, with placebo in patients with active ankylosing spondylitis (AS, radiographic axial spondyloarthritis). In this 16-week (12-week treatment, 4-week washout), phase II, multicentre, dose-ranging trial, adult patients with active AS were randomised (N=51, 52, 52, 52, respectively) to placebo or tofacitinib 2, 5 or 10 mg twice daily. The primary efficacy endpoint was Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response rate at week 12. Secondary endpoints included objective measures of disease activity, patient-reported outcomes and MRI of sacroiliac joints and spine. Safety was monitored. Emax model analysis of the primary endpoint predicted a tofacitinib 10 mg twice daily ASAS20 response rate of 67.4%, 27.3% higher than placebo. Supportive normal approximation analysis demonstrated tofacitinib 5 mg twice daily ASAS20 response rate significantly higher than placebo (80.8% vs 41.2%; ptofacitinib 2 and 10 mg twice daily demonstrated greater response rate than placebo (51.9% and 55.8%, respectively; not significant). Secondary endpoints generally demonstrated greater improvements with tofacitinib 5 and 10 mg twice daily than placebo. Objective (including MRI) endpoints demonstrated clear dose response. Adverse events were similar across treatment groups with no unexpected safety findings. Dose-dependent laboratory outcome changes returned close to baseline by week 16. Tofacitinib 5 and 10 mg twice daily demonstrated greater clinical efficacy versus placebo in reducing signs, symptoms and objective endpoints of active AS in adult patients with a similar 12-week safety profile as reported in other indications. NCT01786668. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  6. The Effect of 10 Weeks Resistance Training on Cholesterol and Blood Triglyceride Levels of Patients with Fatty Liver Disease.

    Science.gov (United States)

    Valizadeh, Rohollah; Hosseini Askarabadi, Siroos; Karampour, Sedigheh; Abdolhamid Tehrani, Mona

    2014-01-01

    The present study aims to consider the effect of 10 weeks resistance trainings on cholesterol and blood triglyceride (TG) levels of patients with having fatty liver, aged 50 to 60 in National Iranian South Oil Company (NISOC). This research is practical and its plan has been done experimentally with pretest and post-test on experimental and control groups. In this study, 20 samples from 100 patients who referred to sonography clinic in NISOC with distinction of fatty liver were selected randomly and divided into two groups of control (n = 10) and experimental (n = 10). Cholesterol and blood trigly-ceride were measured as pretest. Test of normality for TG was (p = 0/200) by Kolmogorov-Smirnov and (p = 0/070) for cholesterol by Shapiro-Wilk test. After 10 weeks resistance trainings, the analysis and resolution of data were done by computer and SPSS (16) software as well as the descriptive and statistical methods (t-test). Comparison between these two groups showed that 8 weeks resistance trainings with a ≤ 0.05 causes significant decrease in the amount of TG but did not any significant effect on cholesterol of fatty liver patients. How to cite this article: Valizadeh R, Askarabadi SH, Karampour S, Tehrani MA. The Effect of 10 Weeks Resistance Training on Cholesterol and Blood Triglyceride Levels of Patients with Fatty Liver Disease. Euroasian J Hepato-Gastroenterol 2014;4(1):64-65.

  7. Achieving a complete colonic evaluation in patients with incomplete colonoscopy is worth the effort.

    Science.gov (United States)

    Ridolfi, Timothy J; Valente, Michael A; Church, James M

    2014-03-01

    Patients with an incomplete colonoscopy are potentially at risk for missed lesions. The purpose of this work was to identify the percentage of patients completing colonic evaluation after incomplete colonoscopy, the manner in which the evaluation was completed, and the incidence of significant pathology. This was a retrospective analysis of prospectively collected data. The study was conducted in an outpatient colonoscopy clinic in the colorectal surgery department of a tertiary referral center. Patients included those undergoing incomplete colonoscopy from a database of 25,645 colonoscopies performed from 1982 to 2009. Procedures aimed at completing colorectal evaluation were included in the study. Reason for incompletion, secondary study, its success, and findings were measured. A total of 242 patients with incomplete colonoscopies were identified; 166 (69%) were women. The average age of patients was 59 years. Most frequent causes for incomplete colonoscopy were inadequate preparation (34%), pain (30%), and tortuosity (20%). The scope could not pass the splenic flexure in 165 patients (71%). A total of 218 patients (90%) were offered completion studies, and 179 patients (82%) complied. Seventy-three of 82 patients who had a surveillance colonoscopy had a follow-up (89%), compared with 72 (87%) of 83 with symptoms and 40 (74%) of 54 who had a screening. Barium enema (BE) was performed in 74 (41%), repeat colonoscopy in 71 (40%), CT colonography in 17 (9%), and colonoscopy under general anesthesia in 9 patients (5%). Resection with intraoperative/perioperative colonoscopy was required in 8 patients (4%). Repeat colonoscopy found 32 lesions (24 tubular adenomas, 4 tubulovillous adenomas, and 4 sessile serrated polyps) in 17 patients (24%). Radiology demonstrated new abnormalities in 11 (12%) of 91 patients, prompting 7 colonoscopies. In 3 patients, colonoscopy showed an inverted appendix, a tubulovillous adenoma, and a sigmoid stricture. Overall, clinically

  8. Adjuvant chemotherapy with 5-fluorouracil, L-folinic acid and levamisole for patients with colorectal cancer: non-randomised comparison of weekly versus four-weekly schedules--less pain, same gain. QUASAR Colorectal Cancer Study Group.

    Science.gov (United States)

    Kerr, D J; Gray, R; McConkey, C; Barnwell, J

    2000-08-01

    QUASAR is a large trial of adjuvant chemotherapy for colorectal cancer in which clinicians could choose to deliver a standard adjuvant cytotoxic chemotherapy regimen, 5-fluorouracil (5-FU) and L-folinic acid (L-FA), in either a once-weekly or a four-weekly schedule. We report results of a non-randomised comparison between these schedules with respect to survival, recurrence and differential toxicity. In a factorial (2 x 2) trial design, QUASAR compared high-dose (175 mg) versus low-dose (25 mg) L-FA and levamisole versus placebo. The dose of 5-FU was fixed at 370 mg/m2 and although the recommended schedule was i.v. bolus delivery, daily for 5 days repeated four-weekly for 6 months, a significant proportion of randomising clinicians were constrained to deliver once-weekly 5-FU-L-FA for 30 weeks. Four thousand nine hundred twenty-seven patients were entered into QUASAR between May 1994 and October 1997, eighteen hundred twenty-nine of whom have recurred and sixteen hundred eighty-nine died. Similar numbers 2370 vs. 2559 were treated with the once-weekly and four-weekly schedules and the demographic features of the 2 groups were well balanced: stage C, 73.3% once-weekly vs. 71.0% four-weekly; colon, 68.0% vs. 68.3%; high-dose FA, 50.1% vs. 49.9%; levamisole, 49.3% vs. 49.3%; females, 40.2% vs. 41.7%; median age (years) 62 vs. 61. The risk of recurrence and survival were similar regardless of schedule: three-year survival was 70.6% once-weekly vs. 71.0% four-weekly; three-year recurrence risk was 35.6% once-weekly vs. 35.5% four-weekly; But, the once-weekly regimen was much less toxic: number of patients for whom toxicity was reported (once-weekly: four-weekly), stomatitis, 37 vs. 337; diarrhoea, 260 vs. 440; neutropenia, 20 vs. 153. The once-weekly regimen is much less toxic than and, apparently, about as effective as the four-weekly schedule. This suggests that the toxicity of 5-FU-L-FA adjuvant chemotherapy could be reduced substantially by weekly scheduling without

  9. Oral health-related quality of life of edentulous patients after complete dentures relining

    Directory of Open Access Journals (Sweden)

    Krunić Nebojša

    2015-01-01

    Full Text Available Background/Aim. Tooth loss affects oral health-related life quality. More than a third of edentulous patients are not fully satisfied with their complete dentures and mainly complain of insufficient stability, retention, and pain during mastication. Solving the problem may include relining by materials that are based on silicone or acrylic. The aim of this study was to determine the level of patients’ satisfaction before and after relining upper dentures with soft and rigid liners. Methods. The patients (n = 24 were divided into two study groups. Maxillary denture relining of the first group of patients was performed with hard acrylic based resins while in the second group of patients complete denture was relined with a silicone-based soft liner. They were asked the questions from the specifically adapted the Oral Health Impact Profile Questionnaire for edentulous patients before and three months after relining dentures. Results. After relining the patients showed a higher degree of satisfaction with their dentures in all the tested domains (masticatory function, psychological discomfort, social disability and retention and hygiene. The patients with soft denture relines were more satisfied. Conclusion. Relining of maxillary complete dentures significantly positively impacts the quality of life of patients in all the tested domains (masticatory function, psychological discomfort, social disability, pain and oral hygiene. Better results were achieved using a silicone-based soft liner, which recommends it as the material of choice for relining dentures.

  10. Patient satisfaction with occlusal scheme of conventional complete dentures: A randomised clinical trial (part I).

    Science.gov (United States)

    Moradpoor, H; Arabzade Hoseini, M; Savabi, O; Shirani, M

    2018-01-01

    Occlusal scheme can affect denture retention, stability, occlusal force distribution, aesthetics, masticatory function, patient comfort and general patient satisfaction with dentures. This study aimed to compare the patient satisfaction with 3 types of complete denture occlusion including fully bilateral balanced occlusion (FBBO), newly presented buccalised occlusion (BO) and lingualised occlusion (LO). In this parallel randomised clinical trial, new conventional complete dentures were fabricated for 86 volunteers. Participants were randomly allocated to 3 groups with 3 different occlusal schemes. All patients were recalled at 1 and 3 months after delivery for data collection. The 19-item version of Oral Health Impact Profile for Edentulous Patients questionnaire was used in this study. The visual analogue scale (VAS) was used for assessment of the prosthodontist's attitude towards denture quality, patient's attitude towards different occlusal schemes and evaluation of patient satisfaction. Data were analysed using the Wilcoxon signed rank test, the Kruskal-Wallis test and the post hoc Dunn test via SPSS version 18.0 (P ≤ .05). Eighty-six patients completed the study, and their data were analysed (mean age ± standard deviation = 57.78 ± 9.98 years). The only significant difference when comparing the 3 groups was physical pain, which was significantly higher in FBBO group. No significant differences were found for the VAS scores of patient and prosthodontist satisfaction or the domain scores among the 3 occlusal schemes either at 1 or at 3 months post-delivery. The VAS score of patient satisfaction and prosthodontist satisfaction increased at third compared to first month after delivery. The results of this randomised clinical trial provided evidence that BO is as effective as LO for the fabrication of complete dentures. © 2017 John Wiley & Sons Ltd.

  11. Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures

    Directory of Open Access Journals (Sweden)

    Gray Janine C

    2012-08-01

    Full Text Available Abstract Background According to the UK Adult Dental Health Survey (2009 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. Methods/Design IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone. Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period. Patients will then wear each set of dentures for a period of 8 weeks (in random order during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period. Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference and confirmation period (adjusted denture preference. A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300. Discussion

  12. Reduction of perception of chronic fatigue in an observational study of patients receiving 12 weeks of Kampo therapy.

    Science.gov (United States)

    Sekiya, Nobuyasu; Shimada, Yutaka; Shintani, Takahiro; Tahara, Eiichi; Kouta, Kazufumi; Shibahara, Naotoshi; Terasawa, Katsutoshi

    2005-10-01

    The aim of this study was to observe the influence of Kampo therapy on latent chronic fatigue of patients with chronic diseases. One hundred and seventy-three (173) consecutive patients with chronic diseases came to our department for the first time. This was a prospective study. Patients were divided into two groups: a chronic fatigue group (CFG) and a nonchronic fatigue group (NCFG). Based on Kampo diagnosis, both groups were prescribed Kampo formulae as an extract or decoction for 12 weeks. By using questionnaires, patients were assessed concerning their physical and mental types of fatigue, their sleep situation, and their attitude toward work or housekeeping, both before and after 12 weeks of treatment, according to Kampo diagnosis. The mental fatigue, physical fatigue, and sleep scores of both groups, and the work score of CFG, were decreased. The rate of reduction of the fatigue score was significantly greater in CFG than in NCFG. The factor responsible for this difference in fatigue score was physical fatigue. A reduction of the perception of chronic fatigue was observed in patients receiving 12 weeks of Kampo therapy.

  13. The experience of daily life of acutely admitted frail elderly patients one week after discharge from the hospital

    DEFF Research Database (Denmark)

    Andreasen, Jane; Lund, Hans; Aadahl, Mette

    2015-01-01

    INTRODUCTION: Frail elderly are at higher risk of negative outcomes such as disability, low quality of life, and hospital admissions. Furthermore, a peak in readmission of acutely admitted elderly patients is seen shortly after discharge. An investigation into the daily life experiences...... of the frail elderly shortly after discharge seems important to address these issues. The aim of this study was to explore how frail elderly patients experience daily life 1 week after discharge from an acute admission. METHODS: The qualitative methodological approach was interpretive description. Data were...... gathered using individual interviews. The participants were frail elderly patients over 65 years of age, who were interviewed at their home 1 week after discharge from an acute admission to a medical ward. RESULTS: Four main categories were identified: "The system," "Keeping a social life," "Being...

  14. Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement With Standardized Versus Procedure-Specific Consent Forms.

    Science.gov (United States)

    Pomeroy, Eoghan; Shaarani, Shahril; Kenyon, Robert; Cashman, James

    2017-08-25

    Informed consent plays a pivotal role in the operative process, and surgeons have an ethical and legal obligation to provide patients with information to allow for shared decision-making. Unfortunately, patient recall after the consent process is frequently poor. This study aims to evaluate the effect of procedure-specific consent forms on patient's recall four weeks after total hip replacement (THR). This is a prospective study using a posttest-only control group design. Sixty adult patients undergoing total hip replacement were allocated to be consented using either the generic or the surgery-specific consent form. Four weeks after surgery, a phone interview was conducted to assess patient's recall of risk of surgical complications. Patient demographic characteristics and educational attainment were similar in both groups. There was a statistically significant increase in the mean number of risks recalled in the study group at 1.43 compared with 0.67 in the control group (P = 0.0131). Consent is a complex process, and obtaining informed consent is far from straightforward. A statistically significant improvement in patient's recall with the use of procedure-specific consent forms was identified, and based on this, we would advocate their use. However, overall patient recall in both groups was poor. We believe that improving the quality of informed consent may require the sum of small gains, and the use of procedure-specific consent forms may aid in this regard.

  15. Comparison of patient's satisfaction with implant-supported mandibular overdentures and complete dentures

    Directory of Open Access Journals (Sweden)

    Yu-Hwa Pan

    2014-06-01

    Full Text Available Background: The purpose of this study was to compare patients' subjective experiences with respect to long-term satisfaction with mandibular implant-retained overdentures versus conventional complete dentures. Methods: Among 85 completely edentulous patients, 60 were treated with four one-stage titanium implants and overdentures retained by a cast bar with extracoronal attachments. These patients constituted the experimental group, and were subsequently evaluated clinically over a period of up to 6 years. The other 25 patients constituted the control group and were treated with conventional complete dentures without implant retained. All the patients (n = 60 in the experimental group responded to questions on their experiences before and after treatment with the implant-retained overdentures. Sixty percent (n = 15 of the 25 patients in the control group responded to the questionnaire. Results: No implants or restorations failed during the observation period. The experimental group, however, showed significant differences with the control group in terms of their responses to the questionnaire. Conclusion: The use of implants to retain and support the overdenture improved comfort and gave the experimental patients greater self-confidence in social interactions, in addition to more effective oral rehabilitation. The results demonstrate that the effects of rehabilitation of the mandibular arch with an implant-retained overdenture are predictable.

  16. Safe and Effective Use of the Once Weekly Dulaglutide Single-Dose Pen in Injection-Naïve Patients With Type 2 Diabetes.

    Science.gov (United States)

    Matfin, Glenn; Van Brunt, Kate; Zimmermann, Alan G; Threlkeld, Rebecca; Ignaut, Debra A

    2015-04-21

    This 4-week, phase 3b, multicenter, open-label, single-arm, outpatient study demonstrated the safe and effective use of the dulaglutide single-dose pen containing 0.5 mL of placebo for subcutaneous injection in injection-naïve adult patients with type 2 diabetes (T2D), with A1C ≤ 8.5% (69 mmol/mol), BMI ≥ 23 kg/m2 and ≤ 45 kg/m(2). Patients completed a modified self-injecting subscale of the Diabetes Fear of Injecting and Self-Testing Questionnaire (mD-FISQ) and were trained to self-inject with the single-dose pen. Patients completed the initial self-injection at the site, injected at home for 2 subsequent weeks, and returned to the site for the final injection. The initial and final self-injections were evaluated for success; the final (initial) self-injection success rate was the primary (secondary) outcome measure, and the primary (secondary) objective was to demonstrate this success rate as being significantly greater than 80%. Patients recorded their level of pain after each injection. After the final injection, patients completed the mD-FISQ and the Medication Delivery Device Assessment Battery (MDDAB) to assess their perceptions of the single-dose pen, including ease of use and experience with the device. Among 211 patients (mean age: 61 years), the primary objective was met, with a final injection success rate of 99.1% (95% CI: 96.6% to 99.7%). Among 214 patients, the initial injection success rate was 97.2% (95% CI: 94.0% to 98.7%), meeting the key secondary objective. Overall, most patients (>96%) found the device easy to use, were satisfied with the device, and would be willing to continue to use the single-dose pen after the study. There was a significant reduction (P injecting, as measured by the mD-FISQ. The dulaglutide single-dose pen was found to be a safe and effective device for use by patients with T2D who were injection-naïve. A positive injection experience is an important factor for patients and providers when initiating injectable

  17. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.

    Science.gov (United States)

    Park, Won; Yoo, Dae Hyun; Jaworski, Janusz; Brzezicki, Jan; Gnylorybov, Andriy; Kadinov, Vladimir; Sariego, Irmgadt Goecke; Abud-Mendoza, Carlos; Escalante, William Jose Otero; Kang, Seong Wook; Andersone, Daina; Blanco, Francisco; Hong, Seung Suh; Lee, Sun Hee; Braun, Jürgen

    2016-01-20

    CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs). This was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) to receive CT-P13 (5 mg/kg) or RP (5 mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed. Of 250 randomized patients (n = 125 per group), 210 (84.0 %) completed 54 weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13 -3.1 versus RP -2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54 weeks, 19.5 % and 23.0 % of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54 weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events

  18. Weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF) as first-line chemotherapy for elderly patients with advanced gastric cancer: results of a phase II trial

    International Nuclear Information System (INIS)

    Santini, D; Vincenzi, B; Russo, A; Caraglia, M; Virzi, V; Cascinu, S; Tonini, G; Graziano, F; Catalano, V; Di Seri, M; Testa, E; Baldelli, AM; Giordani, P; La Cesa, A; Spalletta, B

    2006-01-01

    Elderly patients have been often excluded from or underrepresented in the study populations of combination chemotherapy trials. The primary end point of this study was to determine the response rate and the toxicity of the weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF) regimen in elderly patients with advanced gastric cancer. The secondary objective was to measure the time to disease progression and the survival time. Chemotherapy-naive patients with advanced gastric cancer aged 70 or older were considered eligible for study entry. Patients received weekly oxaliplatin 40 mg/m2, fluorouracil 500 mg/m2 and folinic acid 250 mg/m2. All drugs were given intravenously on a day-1 schedule. A total of 42 elderly patients were enrolled. Median age was 73 years and all patients had metastatic disease. The response rate according to RECIST criteria was 45.2% (95% CIs: 30%–56%) with two complete responses, 17 partial responses, 13 stable diseases and 10 progressions, for an overall tumor rate control of 76.2% (32 patients). Toxicity was generally mild and only three patients discontinued treatment because of treatment related adverse events. The most common treatment-related grade 3/4 adverse events were fatigue (7.1%), diarrhoea (4.8%), mucositis (2.4%), neurotoxicity (2.4%) and neutropenia (4.8%). The median response duration was 5.3 months (95% CIs: 2.13 – 7.34), the median time to disease progression was 5.0 months (95% CIs: 3.75 – 6.25) and the median survival time was 9.0 months (95% CIs: 6.18 – 11.82). OXALF represents an active and well-tolerated treatment modality for elderly patients with locally advanced and metastatic gastric cancer

  19. Weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF as first-line chemotherapy for elderly patients with advanced gastric cancer: results of a phase II trial

    Directory of Open Access Journals (Sweden)

    Vincenzi B

    2006-05-01

    Full Text Available Abstract Background Elderly patients have been often excluded from or underrepresented in the study populations of combination chemotherapy trials. The primary end point of this study was to determine the response rate and the toxicity of the weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF regimen in elderly patients with advanced gastric cancer. The secondary objective was to measure the time to disease progression and the survival time. Methods Chemotherapy-naive patients with advanced gastric cancer aged 70 or older were considered eligible for study entry. Patients received weekly oxaliplatin 40 mg/m2, fluorouracil 500 mg/m2 and folinic acid 250 mg/m2. All drugs were given intravenously on a day-1 schedule. Results A total of 42 elderly patients were enrolled. Median age was 73 years and all patients had metastatic disease. The response rate according to RECIST criteria was 45.2% (95% CIs: 30%–56% with two complete responses, 17 partial responses, 13 stable diseases and 10 progressions, for an overall tumor rate control of 76.2% (32 patients. Toxicity was generally mild and only three patients discontinued treatment because of treatment related adverse events. The most common treatment-related grade 3/4 adverse events were fatigue (7.1%, diarrhoea (4.8%, mucositis (2.4%, neurotoxicity (2.4% and neutropenia (4.8%. The median response duration was 5.3 months (95% CIs: 2.13 – 7.34, the median time to disease progression was 5.0 months (95% CIs: 3.75 – 6.25 and the median survival time was 9.0 months (95% CIs: 6.18 – 11.82. Conclusion OXALF represents an active and well-tolerated treatment modality for elderly patients with locally advanced and metastatic gastric cancer.

  20. Efficacy and safety of saxagliptin in combination with insulin in Japanese patients with type 2 diabetes mellitus: a 16-week double-blind randomized controlled trial with a 36-week open-label extension.

    Science.gov (United States)

    Kadowaki, Takashi; Muto, Satsuki; Ouchi, Yoshiumi; Shimazaki, Ryutaro; Seino, Yutaka

    2017-12-01

    We examined the efficacy and safety of saxagliptin as an add-on to insulin in Japanese patients with type 2 diabetes mellitus. We randomized 240 patients with type 2 diabetes mellitus on insulin monotherapy to 5-mg saxagliptin or placebo as add-on therapy for a 16-week, double-blind period. All patients received 5-mg saxagliptin and insulin for an additional 36 weeks (open-label extension). Change in hemoglobin A1c (HbA1c) at Week 16 was the main endpoint. At Week 16, the adjusted change in HbA1c from baseline increased by 0.51% with placebo and decreased by 0.40% with saxagliptin (difference -0.92% [95% confidence interval -1.07%, -0.76%; p 1]). In patients receiving saxagliptin, reductions in HbA1c at Week 16 were maintained to Week 52, while switching from placebo to saxagliptin resulted in a similar reduction in HbA1c. The incidence of hypoglycemia was not markedly increased with saxagliptin versus placebo in the double-blind period and did not increase substantially during the open-label extension period. The efficacy and safety of saxagliptin was similar between the elderly and non-elderly patient groups. Adding saxagliptin to ongoing insulin therapy improved glycemic control and was well tolerated in Japanese patients with type 2 diabetes.

  1. A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma.

    Science.gov (United States)

    Kim, Young Saing; Lee, Soon Il; Park, Se Hoon; Park, Silvia; Hwang, In Gyu; Lee, Sang-Cheol; Sun, Jong-Mu; Lee, Jeeyun; Lim, Ho Yeong

    2016-02-01

    The present multicenter phase II study evaluated the efficacy and safety of weekly docetaxel as second-line chemotherapy for metastatic urothelial carcinoma. Weekly docetaxel was well tolerated but demonstrated modest activity, with a response rate of 6%, a median progression-free survival (PFS) of 1.4 months, and a median overall survival (OS) of 8.3 months. The dichotomy between PFS and OS was likely associated with subsequent platinum-based chemotherapy received by 58% of the patients. Docetaxel is commonly used for second-line therapy for metastatic urothelial carcinoma (UC). However, myelosuppression is a substantial concern when the traditional 3-week docetaxel cycle is used. The present multicenter phase II study evaluated the efficacy and safety of weekly docetaxel as second-line chemotherapy for metastatic UC. Patients with progression after previous platinum-based chemotherapy for advanced or metastatic disease were treated with docetaxel 30 mg/m(2) on days 1 and 8 every 21 days. The primary endpoint was the response rate. The study enrolled 31 patients. Their median age was 64 years (range, 40-79 years). An Eastern Cooperative Oncology Group performance status of 1, liver metastasis, and a hemoglobin level chemotherapy had been administered for metastatic disease in 29 patients (94%). Although fatigue (13%) and anorexia (6%) were the most frequently observed grade 3 to 4 toxicities, the safety profiles were generally mild and manageable. Two patients (6%) achieved an objective response, which was maintained for 3.0 to 7.8 months. Eight patients experienced disease stabilization (disease control rate, 32%). The median progression-free survival (PFS) and overall survival (OS) were 1.4 months (95% confidence interval [CI], 1.3-1.6) and 8.3 months (95% CI, 5.9-10.6), respectively. A relatively long OS was associated with further salvage platinum-based chemotherapy (n = 18, 58%) showing an encouraging activity (response rate, 44%; median PFS, 4.0 months

  2. Limited utility of routine surveillance imaging for classical Hodgkin lymphoma patients in first complete remission.

    Science.gov (United States)

    Pingali, Sai Ravi; Jewell, Sarah W; Havlat, Luiza; Bast, Martin A; Thompson, Jonathan R; Eastwood, Daniel C; Bartlett, Nancy L; Armitage, James O; Wagner-Johnston, Nina D; Vose, Julie M; Fenske, Timothy S

    2014-07-15

    The objective of this study was to compare the outcomes of patients with classical Hodgkin lymphoma (cHL) who achieved complete remission with frontline therapy and then underwent either clinical surveillance or routine surveillance imaging. In total, 241 patients who were newly diagnosed with cHL between January 2000 and December 2010 at 3 participating tertiary care centers and achieved complete remission after first-line therapy were retrospectively analyzed. Of these, there were 174 patients in the routine surveillance imaging group and 67 patients in the clinical surveillance group, based on the intended mode of surveillance. In the routine surveillance imaging group, the intended plan of surveillance included computed tomography and/or positron emission tomography scans; whereas, in the clinical surveillance group, the intended plan of surveillance was clinical examination and laboratory studies, and scans were obtained only to evaluate concerning signs or symptoms. Baseline patient characteristics, prognostic features, treatment records, and outcomes were collected. The primary objective was to compare overall survival for patients in both groups. For secondary objectives, we compared the success of second-line therapy and estimated the costs of imaging for each group. After 5 years of follow-up, the overall survival rate was 97% (95% confidence interval, 92%-99%) in the routine surveillance imaging group and 96% (95% confidence interval, 87%-99%) in the clinical surveillance group (P = .41). There were few relapses in each group, and all patients who relapsed in both groups achieved complete remission with second-line therapy. The charges associated with routine surveillance imaging were significantly higher than those for the clinical surveillance strategy, with no apparent clinical benefit. Clinical surveillance was not inferior to routine surveillance imaging in patients with cHL who achieved complete remission with frontline therapy. Routine

  3. Low Completeness of Bacteraemia Registration in the Danish National Patient Registry.

    Directory of Open Access Journals (Sweden)

    Kim Oren Gradel

    Full Text Available Bacteraemia is associated with significant morbidity and mortality and timely access to relia-ble information is essential for health care administrators. Therefore, we investigated the complete-ness of bacteraemia registration in the Danish National Patient Registry (DNPR containing hospital discharge diagnoses and surgical procedures for all non-psychiatric patients. As gold standard we identified bacteraemia patients in three defined areas of Denmark (~2.3 million inhabitants from 2000 through 2011 by use of blood culture data retrieved from electronic microbiology databases. Diagnoses coded according to the International Classification of Diseases, version 10, and surgical procedure codes were retrieved from the DNPR. The codes were categorized into seven groups, ranked a priori according to the likelihood of bacteraemia. Completeness was analysed by contin-gency tables, for all patients and subgroups. We identified 58,139 bacteraemic episodes in 48,450 patients; 37,740 episodes (64.9% were covered by one or more discharge diagnoses within the sev-en diagnosis/surgery groups and 18,786 episodes (32.3% had a code within the highest priority group. Completeness varied substantially according to speciality (from 17.9% for surgical to 36.4% for medical, place of acquisition (from 26.0% for nosocomial to 36.2% for community, and mi-croorganism (from 19.5% for anaerobic Gram-negative bacteria to 36.8% for haemolytic strepto-cocci. The completeness increased from 25.1% in 2000 to 35.1% in 2011. In conclusion, one third of the bacteraemic episodes did not have a relevant diagnosis in the Danish administrative registry recording all non-psychiatric contacts. This source of information should be used cautiously to iden-tify patients with bacteraemia.

  4. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial.

    Science.gov (United States)

    Cruz-Díaz, David; Romeu, Marta; Velasco-González, Carmen; Martínez-Amat, Antonio; Hita-Contreras, Fidel

    2018-04-01

    To assess the effectiveness of 12 weeks of Pilates practice on disability, pain and kinesiophobia in patients with chronic non-specific low back pain. This is a randomized controlled trial. This study was conducted in the university laboratory. A total of 64 participants with chronic non-specific low back pain were included. Participants were randomly allocated to intervention group consisted in Pilates intervention during 12 weeks ( n = 32) or control group who received no treatment ( n = 32). Disability, pain and kinesiophobia were assessed by Roland Morris Disability Questionnaire, visual analogue scale and Tampa Scale of Kinesiophobia, respectively. Measurements were performed at baseline, at 6 and 12 weeks after study completion. There were significant differences between groups with observed improvement in Pilates intervention group in all variables after treatment ( P Pilates intervention in patients with chronic non-specific low back pain is effective in the management of disability, pain and kinesiophobia.

  5. A renal transplant patient with abdominal discomfort, vomiting and diarrhoea for 1 week.

    Science.gov (United States)

    Lutwak, Nancy; Dill, Curt

    2011-08-24

    The patient is a 61-year-old diabetic male with history of renal transplant who presented to the emergency department with complaints of intermittent abdominal discomfort accompanied by multiple episodes of vomiting and diarrhoea. He had delayed seeking medical attention until his friends insisted that he come to the emergency department, since the abdominal discomfort was worsening. The patient's ECG revealed an ST-segment elevation myocardial infarction.

  6. A cephalometric study to determine the plane of occlusion in completely edentulous patients.

    Science.gov (United States)

    Hindocha, Amit D; Vartak, Vikas N; Bhandari, Aruna J; Dudani, Mohit T

    2013-01-01

    Determination of the plane of occlusion in completely edentulous patients with the help of the ala-tragus line (Camper's plane) may be questioned. An attempt to devise an alternative method to determine the orientation of the plane of occlusion was made. Cephalometric analysis was used to identify whether a correlation exists between the plane of occlusion of dentulous Indian individuals and other stable cranial landmarks. A negative correlation was found to exist between the occlusal Plane-FH plane angle and the porion-nasion-anterior nasal spine (PoNANS) angle. From the derived mathematical correlation, it was concluded that the angulation of the occlusal plane in completely edentulous subjects may be determined by taking a cephalogram at the diagnostic stage. Further, the clinical applicability of the derived mathematical formula (while determining the plane of occlusion) was tested on completely edentulous patients.

  7. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement

    DEFF Research Database (Denmark)

    Skou, Søren Thorgaard; Rasmussen, Sten; Laursen, Mogens Berg

    2015-01-01

    OBJECTIVE: To compare the efficacy of a 12-week non-surgical treatment program with usual care in patients with knee osteoarthritis (OA) not eligible for total knee replacement (TKR). METHOD: This two-arm parallel group assessor-blinded randomized controlled trial (RCT) included 100 adults from...... secondary care with knee OA, confirmed by radiography (Kellgren-Lawrence grade ≥1), but not eligible for a TKR. The 12-week non-surgical treatment program consisted of individualized progressed neuromuscular exercise, patient education, insoles, dietary advice and prescription of pain medication...... if indicated, while usual care comprised two leaflets with information and advice on knee OA and recommended treatments. The primary outcome was the change from baseline to 12 months in the Knee injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the KOOS subscales of pain...

  8. The Effect of a Complex (3-week Therapy on the Hip and Knee Joints in Obese Patients

    Directory of Open Access Journals (Sweden)

    Tóvári Anett

    2015-05-01

    Full Text Available Currently, overweight and obesity are the most widespread problems in life-style having a significant impact on everyday life, and thus, conduct of life. Further contributory problems may develop in patients with weight problems: deformities of the joints and skeleton (coxarthrosis and gonarthrosis, circulatory problems and arrhythmia. Overweight definitely has an effect on motion: some people are not involved in certain activities as it is impossible for them because of their weight problem. Thus, even more health problems are generated because of the overweight. The first question arising in discussing the actuality of this issue is what effect the applied therapy (massage, therapeutic exercises, electrotherapy and balneotherapy has on the knee and hip joints of patients with weight problems hospitalised in our Institute for a 3-week complex therapy. Based on my prior hypothesis, positive changes are detected in a minimum percentage in the condition of overweight or obese patients. My hypothesis was that the range of flexion and extension of the hip and knee joints would improve compared to other movements. Based on the results of the studied population (n=30, my hypothesis seems to be proven. After the 3-week complex therapy of obese patients, positive changes were found in the prearranged assessments and tests, thereby improving the general health, life-style, life quality and mental status of the patients. After the end of the complex therapy, patients were provided life-style counselling and exercise schemes to be performed in their home to maintain the achieved health status.

  9. Patient Characteristics Associated with HCV Treatment Adherence, Treatment Completion, and Sustained Virologic Response in HIV Coinfected Patients

    Directory of Open Access Journals (Sweden)

    Glenn Wagner

    2011-01-01

    Full Text Available Background. Hepatitis C (HCV treatment efficacy among HIV patients is limited by poor treatment adherence and tolerance, but few studies have examined the psychosocial determinants of treatment adherence and outcomes. Methods. Chart abstracted and survey data were collected on 72 HIV patients who had received pegylated interferon and ribavirin to assess correlates of treatment adherence, completion, and sustained virologic response (SVR. Results. Nearly half (46% the sample had active psychiatric problems and 13% had illicit drug use at treatment onset; 28% reported <100% treatment adherence, 38% did not complete treatment (mostly due to virologic nonresponse, and intent to treat SVR rate was 49%. Having a psychiatric diagnosis was associated with nonadherence, while better HCV adherence was associated with both treatment completion and SVR. Conclusions. Good mental health may be an indicator of HCV treatment adherence readiness, which is in turn associated with treatment completion and response, but further research is needed with new HCV treatments emerging.

  10. Prognosis of Esophageal Cancer Patients With Pathologic Complete Response After Preoperative Concurrent Chemoradiotherapy

    International Nuclear Information System (INIS)

    Park, Jae Won; Kim, Jong Hoon; Choi, Eun Kyung; Lee, Sang-wook; Yoon, Sang Min; Song, Si Yeol; Lee, Yu Sun; Kim, Sung Bae; Park, Seung il; Ahn, Seung Do

    2011-01-01

    Purpose: To define failure patterns and predictive factors in esophageal cancer patients who had a pathologic complete response (pCR) after preoperative concurrent chemoradiotherapy (PCRT). Methods and Materials: We performed a retrospective analysis of 61 esophageal cancer patients who were enrolled in prospective studies and showed pCR after PCRT. All of the patients had squamous cell carcinoma. Of the patients, 40 were treated with hyperfractionated radiotherapy (4,560 cGy in 28 fractions) with 5-fluorouracil (5-FU) and cisplatin (FP), and 21 patients received conventional fractionation radiotherapy with capecitabine and cisplatin (XP). Results: The median follow-up time was 45.2 months (range, 6.5-162.3 months). The 5-year overall survival (OS) and disease-free survival rates (DFS) were 60.2% and 80.4%, respectively. In univariate analysis, age and lymph node (LN) metastasis were poor prognostic factors for OS, and pretreatment weight loss (>2 kg) was a poor prognostic factor for DFS. In multivariate analysis, lymph node metastasis and pretreatment weight loss were independent prognostic factors for OS and DFS. Nine patients (15%) had disease recurrence. Of the nine patients, 5 patients had locoregional failure, 1 patients had distant metastasis, and 3 patients had distant and locoregional failure. In-field failure occurred in 5 patients; out-of-field failure occurred in 1 patient; both in-field and out-of-field failure occurred in 2 patients; and both marginal and out-of-field failure occurred in 1 patient. Conclusions: Even in pCR patients, the most common failure site was within the radiation field, which suggests that more efficient local treatment is needed. Tumor recurrence was more common in patients with older age and with pretreatment weight loss.

  11. Zygomatic implant-retained fixed complete denture for an elderly patient.

    Science.gov (United States)

    Baig, Mirza Rustum; Rajan, Gunaseelan; Yunus, Norsiah

    2012-06-01

    Dental rehabilitation of a completely edentulous geriatric patient has always been a challenge to the clinician, especially in treating those with higher expectations and demands. Treatment duration and the amount of residual alveolar bone available are often important considerations when planning for dental implant-based fixed treatment for these patients. With the introduction of zygomatic implants, a graftless alternative solution has emerged for deficient maxillary bone with provision for immediate loading. This article describes the treatment of a completely edentulous elderly patient using zygomatic implants in conjunction with conventional implants. The implants were immediately loaded using a definitive acrylic resin fixed denture reinforced with a cast metal framework, to provide function and aesthetics. © 2011 The Gerodontology Society and John Wiley & Sons A/S.

  12. A 12-Week Exercise Therapy Program in Middle-Aged Patients With Degenerative Meniscus Tears

    DEFF Research Database (Denmark)

    Stensrud, Silje; Roos, Ewa M.; Risberg, May Arna

    2012-01-01

    Normal 0 false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 STUDY DESIGN: Case Series. BACKGROUND: Exercise is a viable treatment alternative to arthroscopic partial meniscectomy in patients with degenerative meniscus tears. No study has reported in detail type of exercises, progres......Normal 0 false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 STUDY DESIGN: Case Series. BACKGROUND: Exercise is a viable treatment alternative to arthroscopic partial meniscectomy in patients with degenerative meniscus tears. No study has reported in detail type of exercises......, progression, tolerance, and potential benefit from an exercise therapy program in these patients who have not had surgery. This study describes a progressive exercise therapy program aiming at improving neuromuscular function and muscle strength in middle-aged patients with degenerative meniscus tears...... had undergone surgery. DISCUSSION: The described neuromuscular- and strength-training program should be considered for rehabilitation of middle-aged individuals with degenerative meniscus tears. Head-to-head comparison of programs in a randomized design is however needed to be able to answer...

  13. Use of a patient completed iPad questionnaire to improve pre-operative assessment.

    Science.gov (United States)

    Howell, M; Hood, A J; Jayne, D G

    2017-02-01

    Developments in healthcare technology could improve patient care and reduce healthcare costs. There is a need to facilitate communication and increase efficiency in surgical pre-assessment clinics. This study aimed to develop an iPad application to deliver an electronic patient questionnaire, and to evaluate its use in the pre-assessment environment. Software was developed, MyOp, for a standard iPad that mirrored the paper-based pre-assessment system, with features designed for ease of patient use and remote data transfer. A case-control study was conducted, comparing use of MyOp with paper-based practice, to evaluate feasibility and patient preference. Patients were offered the use of MyOp or paper-based system. Outcomes measured included time to complete iPad questionnaire, consultation duration, and a patient preference questionnaire. MyOp cost £3500 to develop. 104 individuals participated in the study, 53 MyOp and 51 controls. MyOp reduced the median consultation duration by 5.00 min. A reduction was seen in all subgroups except those aged over 70 or urology patients. Patients preferred to complete the form independently, using a touchpad or computer but expressed concerns about data security. Use of an electronic patient questionnaire reduces consultation time delivering greater efficiency of pre-assessment nurse time. Preconceived ideas about the use of technology in older age groups are likely inaccurate and less of a barrier than previously thought. Electronic pre-assessments could be used routinely to reduce demands on healthcare facilities, improve patient care, and triage patients prior to clinic attendance.

  14. Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis: HIT HARD, an investigator-initiated study.

    Science.gov (United States)

    Detert, Jacqueline; Bastian, Hans; Listing, Joachim; Weiß, Anja; Wassenberg, Siegfried; Liebhaber, Anke; Rockwitz, Karin; Alten, Rieke; Krüger, Klaus; Rau, Rolf; Simon, Christina; Gremmelsbacher, Eva; Braun, Tanja; Marsmann, Bettina; Höhne-Zimmer, Vera; Egerer, Karl; Buttgereit, Frank; Burmester, Gerd-R

    2013-06-01

    To investigate the long-term effects of induction therapy with adalimumab (ADA) plus methotrexate (MTX) in comparison with placebo (PBO) plus MTX in DMARD-naïve patients with active early rheumatoid arthritis (RA). Patients with active early RA (disease duration of ≤12 months) were randomly assigned to receive 40 mg ADA subcutaneously every other week (eow) plus MTX 15 mg/week subcutaneously or PBO plus MTX subcutaneously at 15 mg/week over 24 weeks. Thereafter, all patients received MTX monotherapy up to week 48. The primary outcome was the Disease Activity Score 28 (DAS28) at week 48. Secondary outcomes included proportions of patients in remission (DAS28Health Assessment Questionnaire (HAQ) score and radiographic progression. 87 patients were assigned to ADA/MTX and 85 patients to PBO/MTX. At baseline, DAS28 was 6.2±0.8 in the ADA/MTX and 6.3±0.9 in the PBO/MTX groups. At week 24, treatment with ADA/MTX compared with PBO/MTX resulted in a greater reduction in DAS28 (3.0±1.2 vs 3.6±1.4; p=0.009) and other secondary outcomes such as DAS28 remission rate (47.9% vs 29.5%; p=0.021) and HAQ (0.49±0.6 vs 0.72±0.6; p=0.0014). At week 48, the difference in clinical outcomes between groups was not statistically significant (DAS28: 3.2±1.4 vs 3.4±1.6; p=0.41). Radiographic progression at week 48 was significantly greater in patients administered PBO/MTX (Sharp/van der Heijde score: ADA/MTX 2.6 vs PBO/MTX 6.4; p=0.03, Ratingen score: 1.7 vs 4.2; p=0.01). A greater reduction in radiographic progression after initial combination therapy with ADA and MTX was seen at week 48, even after discontinuation of ADA treatment at week 24. This sustained effect was not found at the primary endpoint (DAS28 reduction).

  15. Indicators of a poor outcome after temporary pacing in patients with complete atrioventricular block

    International Nuclear Information System (INIS)

    Kazmi, U.; Hyder, S.N.; Sheikh, A.M.

    2013-01-01

    Background: Temporary pace maker (tpm) implantation is an emergency procedure, performed in symptomatic patients with AV block We report our experience of temporary pacing at a tertiary care center. It is the first study of its type from a local center. Objectives: To study the clinical course of patients after tpm implantation and to determine indicators of a poor outcome after tpm implantation. Methods: This was descriptive retrospective study. Data of all tpm procedures performed at Children Hospital from 2006 to 2012 was retrieved. We excluded patients with surgically placed tpm leads. All patients receiving transvenous tpm were included in our study. Results: Total of 12 patients received tpm, 8 were male (66.6%) and 4 were female (33.3%). Median age was 6 years ( range 1.4 -13 year ). Mean weight was 30kg, (range 8.7 - 50kg). All of them presented with complete heart block.One patient each had post diphtheria cardiomyopathy, unknown poisoning. The rest had congenital heart block. The mean period between tpm to ppm implantation was 5 days, (range 1 - 30 days). One patient spontaneously reverted to sinus rhythm(8.3%), 6 had ppm implantation (58.3%), 5 patients expired (33.3%). A low Ejection Fraction was found to be associated with a poor outcome (p<0.01). Variables that were associated with a poor outcome(mortality), were SOB (p<0.015), weak pulses (p<0.015), and hepatomegaly (p<0.01). Conclusion: Low Ejection Fraction and Heart failure is associated with a poor outcome and increased mortality in patients with complete AV block. We suggest that pacing should be considered in patients earlier, before they develop signs or symptoms of cardiac dysfunction. (author)

  16. Nursing practice with the patient before complete removal of the stomach from cancer

    Directory of Open Access Journals (Sweden)

    Edyta Medak

    2017-07-01

    Full Text Available Background: Gastric cancer (RZ is the second leading cause of cancer in the world leading to death. Although each year the incidence of RZ is lower, it is still one of the highest in the group of most common malignancies. Due to the fact that cancer patients have similar symptoms to other gastrointestinal diseases, it is often detected at an advanced stage. This cancer can be located in different parts of the stomach and often has an unusual course. Surgical treatment of patients with RZ is most often associated with complete gastric excision and causes numerous ailments. Correct preparation of patients for surgery has a significant impact on therapeutic success. A nurse who carries a cancer patient is not only concerned with assessing his / her current state of health, executing medical orders, education on post-hospital leave, but also providing emotional support before surgery. [1,2,3,16]. Aim of the study: Evaluation of patient treatment before complete removal of the stomach from cancer. Material and method: The study was conducted in the period from 17.09.2012 to 15.05.2013 in the group of 60 patients (35 men and 25 women of the II Department and Clinic of General Surgery, Gastroenterology and Gastrointestinal Cancer of the Independent Public Clinical Hospital No. 1 in Lublin. Patients have been qualified for total abdominal surgery for cancer. The research tool was the author's questionnaire survey. The results of the study were statistically analyzed. Results: According to data obtained, more than half (60% of patients presenting with gastric resection at the Clinic of General Surgery, Gastroenterology and Gastrointestinal Diseases of the Independent Public Clinical Hospital No. 1 in Lublin have a high level of care in this department. There was no case for the patient to underestimate nursing care. Conclusions: The majority of patients rated nursing care performed prior to surgery at a high level.

  17. Prospective evaluation of a 12-week walking exercise program and its effect on fatigue in prostate cancer patients undergoing radical external beam radiotherapy.

    Science.gov (United States)

    Truong, Pauline T; Gaul, Catherine A; McDonald, Rachel E; Petersen, Ross B; Jones, Stuart O; Alexander, Abraham S; Lim, Jan T W; Ludgate, Charles

    2011-08-01

    To evaluate tolerability and compliance to a walking exercise program and its effect on fatigue during and after radical external beam radiation therapy (EBRT) for prostate cancer. A total of 50 subjects with prostate cancer undergoing EBRT over 6 to 8 weeks were prospectively accrued to an exercise intervention group, matched for age and clinical characteristics to 30 subjects in a historical control group who underwent EBRT with no specific exercise intervention. Starting 1 week before EBRT, exercise participants performed moderate-intensity walking targeting 60% to 70% age-predicted maximum heart rate, at least 20 min/d, 3 d/wk over 12 weeks. The Brief Fatigue Inventory was administered at baseline, mid-EBRT (week 3-4), end-EBRT (week 6-8), and 6 months post-EBRT. Of 50, 42 (84%) of exercise participants completed the walking program. There were no cardiovascular complications, musculoskeletal injuries, or other adverse events. A total of 89% subjects reported "Good-Excellent" satisfaction during and up to 6 months post-EBRT. Fatigue in control subjects escalated from baseline to end-EBRT, remaining high at 6 months post-EBRT (P[r] = 0.03). In contrast, mean total fatigue scores in exercise subjects were stable from baseline up to 6 months post-EBRT (P = 0.52). Trends for higher fatigue interference with quality of life were observed in the control group as compared with the exercise group. Moderate-intensity walking exercise during radical EBRT is safe and feasible. The high convenience and satisfaction ratings, in conjunction with the observed fatigue trends, indicate that this activity has the potential to attenuate fatigue and improve quality of life for patients with localized prostate cancer undergoing curative therapy.

  18. Improving response rates using a monetary incentive for patient completion of questionnaires: an observational study

    Directory of Open Access Journals (Sweden)

    Orchard Jo

    2007-02-01

    Full Text Available Abstract Background Poor response rates to postal questionnaires can introduce bias and reduce the statistical power of a study. To improve response rates in our trial in primary care we tested the effect of introducing an unconditional direct payment of £5 for the completion of postal questionnaires. Methods We recruited patients in general practice with knee problems from sites across the United Kingdom. An evidence-based strategy was used to follow-up patients at twelve months with postal questionnaires. This included an unconditional direct payment of £5 to patients for the completion and return of questionnaires. The first 105 patients did not receive the £5 incentive, but the subsequent 442 patients did. We used logistic regression to analyse the effect of introducing a monetary incentive to increase the response to postal questionnaires. Results The response rate following reminders for the historical controls was 78.1% (82 of 105 compared with 88.0% (389 of 442 for those patients who received the £5 payment (diff = 9.9%, 95% CI 2.3% to 19.1%. Direct payments significantly increased the odds of response (adjusted odds ratio = 2.2, 95% CI 1.2 to 4.0, P = 0.009 with only 12 of 442 patients declining the payment. The incentive did not save costs to the trial – the extra cost per additional respondent was almost £50. Conclusion The direct payment of £5 significantly increased the completion of postal questionnaires at negligible increase in cost for an adequately powered study.

  19. Improving response rates using a monetary incentive for patient completion of questionnaires: an observational study

    Science.gov (United States)

    Brealey, Stephen D; Atwell, Christine; Bryan, Stirling; Coulton, Simon; Cox, Helen; Cross, Ben; Fylan, Fiona; Garratt, Andrew; Gilbert, Fiona J; Gillan, Maureen GC; Hendry, Maggie; Hood, Kerenza; Houston, Helen; King, David; Morton, Veronica; Orchard, Jo; Robling, Michael; Russell, Ian T; Torgerson, David; Wadsworth, Valerie; Wilkinson, Clare

    2007-01-01

    Background Poor response rates to postal questionnaires can introduce bias and reduce the statistical power of a study. To improve response rates in our trial in primary care we tested the effect of introducing an unconditional direct payment of £5 for the completion of postal questionnaires. Methods We recruited patients in general practice with knee problems from sites across the United Kingdom. An evidence-based strategy was used to follow-up patients at twelve months with postal questionnaires. This included an unconditional direct payment of £5 to patients for the completion and return of questionnaires. The first 105 patients did not receive the £5 incentive, but the subsequent 442 patients did. We used logistic regression to analyse the effect of introducing a monetary incentive to increase the response to postal questionnaires. Results The response rate following reminders for the historical controls was 78.1% (82 of 105) compared with 88.0% (389 of 442) for those patients who received the £5 payment (diff = 9.9%, 95% CI 2.3% to 19.1%). Direct payments significantly increased the odds of response (adjusted odds ratio = 2.2, 95% CI 1.2 to 4.0, P = 0.009) with only 12 of 442 patients declining the payment. The incentive did not save costs to the trial – the extra cost per additional respondent was almost £50. Conclusion The direct payment of £5 significantly increased the completion of postal questionnaires at negligible increase in cost for an adequately powered study. PMID:17326837

  20. Patient and tumor characteristics associated with breast cancer recurrence after complete pathological response to neoadjuvant chemotherapy.

    Science.gov (United States)

    Ju, Na Rae; Jeffe, Donna B; Keune, Jason; Aft, Rebecca

    2013-01-01

    Breast cancer patients whose tumors achieve a pathological complete response (pCR) with neoadjuvant chemotherapy have a prognosis which is better than that predicted for the stage of their disease. However, within this subgroup of patients, recurrences have been observed. We sought to examine factors associated with recurrence in a population of breast cancer patients who achieved a pCR with neoadjuvant chemotherapy. A retrospective chart review was conducted of all patients with unilateral breast cancer treated with neoadjuvant chemotherapy from January 1, 2000 to December 31, 2010 at one comprehensive cancer center. A pCR was defined as no residual invasive cancer in the breast in the surgical specimen following neoadjuvant therapy. Recurrence was defined as visceral or bony reappearance of cancer after completion of all therapy. Of 818 patients who completed neoadjuvant chemotherapy, 144 (17.6 %) had pCR; six with bilateral breast cancer were excluded from further analysis. The mean time to follow-up was 47.2 months. Among the 138 patients with unilateral breast cancer, there were 14 recurrences (10.1 %). Using a binary multiple logistic regression model, examining types of chemotherapy and surgery, race, lymph node assessment, and lymph node status, breast cancer side, triple-negative status, and radiation receipt, only African-American patients (OR: 5.827, 95 % CI: 1.280-26.525; p = 0.023) were more likely to develop distant recurrence. The mean time to recurrence was 31.9 months. In our study, race was the only independent predictor of recurrence after achieving pCR with neoadjuvant chemotherapy. The reasons for this observation require further study.

  1. Patient-completed or symptom-based screening tools for endometriosis: a scoping review.

    Science.gov (United States)

    Surrey, Eric; Carter, Cathryn M; Soliman, Ahmed M; Khan, Shahnaz; DiBenedetti, Dana B; Snabes, Michael C

    2017-08-01

    The objective of this review was to evaluate existing patient-completed screening questionnaires and/or symptom-based predictive models with respect to their potential for use as screening tools for endometriosis in adult women. Validated instruments were of particular interest. We conducted structured searches of PubMed and targeted searches of the gray literature to identify studies reporting on screening instruments used in endometriosis. Studies were screened according to inclusion and exclusion criteria that followed the PICOS (population, intervention, comparison, outcomes, study design) framework. A total of 16 studies were identified, of which 10 described measures for endometriosis in general, 2 described measures for endometriosis at specific sites, and 4 described measures for deep-infiltrating endometriosis. Only 1 study evaluated a questionnaire that was solely patient-completed. Most measures required physician, imaging, or laboratory assessments in addition to patient-completed questionnaires, and several measures relied on complex scoring. Validation for use as a screening tool in adult women with potential endometriosis was lacking in all studies, as most studies focused on diagnosis versus screening. This literature review did not identify any fully validated, symptom-based, patient-reported questionnaires for endometriosis screening in adult women.

  2. Psychological well-being in obese in-patients with ischemic heart disease at entry and at discharge from a four-week cardiac rehabilitation program

    Directory of Open Access Journals (Sweden)

    Gian Mauro Manzoni

    2010-08-01

    Full Text Available The purposes of this observational pre-post study were twofold: 1- to evaluate psychological health in obese patients with ischemic heart disease (IHD at admission to cardiac rehabilitation (CR and 2 - to examine the effectiveness of a four-week CR residential program in improving obese patients’ psychological well-being at discharge from CR. A sample of 177 obese patients completed the Psychological General Well-Being Inventory (PGWBI at admission to the CR program and at discharge. The equivalence testing method with normative comparisons was used to determine the clinical significance of improvements after having established that baseline mean scores on the PGWBI scales were significantly lower than normal means. Results show that patients scored equally or better than norms on many PGWBI dimensions at admission to CR but scored significantly worse on Global Score, Vitality and Self-control. At discharge, mean scores that were impaired at baseline returned to normal levels at the more conservative equivalence interval. A four-week CR program was thus effective in improving obese patients’ psychological well-being. The equivalence testing method allowed to establish the clinical significance of such improvement.

  3. Exercise training program based on minimum weekly frequencies: effects on blood pressure and physical fitness in elderly hypertensive patients.

    Science.gov (United States)

    Moraes, Wilson M De; Souza, Pamella R M; Pinheiro, Mônica H N P; Irigoyen, Maria C; Medeiros, Alessandra; Koike, Marcia K

    2012-04-01

    Exercise training (ET) can reduce blood pressure (BP) and prevent functional disability. However, the effects of low volumes of training have been poorly studied, especially in elderly hypertensive patients. To investigate the effects of a multi-component ET program (aerobic training, strength, flexibility, and balance) on BP, physical fitness, and functional ability of elderly hypertensive patients. Thirty-six elderly hypertensive patients with optimal clinical treatment underwent a multi-component ET program: two 60-minute sessions a week for 12 weeks at a Basic Health Unit. Compared to pre-training values, systolic and diastolic BP were reduced by 3.6% and 1.2%, respectively (ptest and elbow flexor test; ptest (unipedal stance test; ptest; ptest). Moreover, there was a reduction in the time required to perform two functional ability tests: "put on sock" and "sit down, stand up, and move around the house" (p<0.001). Lower volumes of ET improved BP, metabolic parameters, and physical fitness and reflected in the functional ability of elderly hypertensive patients. Trial Registration RBR-2xgjh3.

  4. Raltitrexed (Tomudex administration in patients with relapsed metastatic colorectal cancer after weekly irinotecan/5-Fluorouracil/Leucovorin chemotherapy

    Directory of Open Access Journals (Sweden)

    Vadiaka Maria

    2002-01-01

    Full Text Available Abstract Purpose The present study aimed at evaluating the efficacy of Raltitrexed, a specific thymidilate synthase inhibitor, in patients with advanced colorectal cancer (ACC in relapse (>8 weeks after a prior response or disease stabilization to first-line chemotherapy combination with lrinotecan+5-Fluorouracil (5-FU+Leucovorin (LV. Methods Twenty-five patients with metastatic ACC entered; 17 males/8 females, median age 61 (range: 47–70, median Karnovsky PS: 80 (70–90, and sites of metastases; liver: 21, lung: 4, lymph nodes: 7, peritoneal: 5 and a life expectancy of at least 3 months, were entered in the present pilot study. All patients had progressed after prior chemotherapy with lrinotecan+5-FU+LV. Raltitrexed was administered at a dose of 3 mg/m2 i.v. every 21 days. Results Three patients (12% achieved a partial response (PR, 8 (32% had stable disease (SD, and the remaining 14 (56% developed progressive disease (PD. Median time-to-progression (TTP was 5.5 months (range, 2–8.5, and median overall survival (OS 8 months (range, 4.0–12.5. Toxicity was generally mild; it consisted mainly of myelosuppression; neutropenia grade 1–2: 52%-grade 3: 28%, and anemia grade 1–2 only: 36%. Mild mucositis grade 1–2 occured in 13.5% of patients and was the principal non-hematologic toxicity. Conclusion Response to treatment with Raltitrexed is limited in patients with ACC failing after an initial response or non-progression to the weekly lrinotecan+5-FU+LV combination. However, it appears that a limited number of patients with PR/SD may derive clinical benefit, but final proof would require a randomized study.

  5. One-week acid suppression trial in uninvestigated dyspepsia patients with epigastric pain or burning to predict response to 8 weeks' treatment with esomeprazole

    DEFF Research Database (Denmark)

    van Zanten, S V; Flook, N; Talley, N J

    2007-01-01

    BACKGROUND: While empiric acid-suppressive therapy for uninvestigated dyspepsia patients with symptoms of epigastric pain or burning is standard practice, it is unknown whether an early response to therapy predicts outcome. AIM: To evaluate whether a 1-w acid suppression trial is effective...... for predicting 8-w response in such patients. METHODS: Helicobacter pylori-negative patients (aged 18-50 years) in primary care with uninvestigated epigastric pain or burning were randomized to esomeprazole 40 mg q.d.s. or b.d. for 1w, followed by esomeprazole 40 mg q.d.s. or placebo for 7w. Each day, patients......, respectively, and 47% (339 of 716) and 34% (124 of 368), respectively, at 8w (both P treatment were 58% and 70%, respectively, at 8w. CONCLUSION: A 1-w acid suppression trial is of limited clinical value for predicting 8-w response...

  6. Treatment of visceral leishmaniasis in a patient with AIDS with antimony and gamma-interferon: remission and prevention of relapse by maintenance therapy with weekly pentamidine

    NARCIS (Netherlands)

    Lustig, V.; Kager, P. A.; Meenhorst, P. L.

    1995-01-01

    A 41-year-old AIDS patient with fever, nightly perspiration, diarrhoea, anaemia and leukopenia was diagnosed as having visceral leishmaniasis (VL). After 8 weeks of antimony treatment combined with gamma-interferon, given in 2 courses of 3 and 5 weeks, 12 weeks apart, the bone marrow revealed no

  7. Multicenter Phase II Study with Weekly Bendamustine and Paclitaxel as First- or Later-Line Therapy in Patients with Metastatic Breast Cancer: RiTa II Trial.

    Science.gov (United States)

    Loibl, Sibylle; Doering, Gabriele; Müller, Lothar; Grote-Metke, Albert; Müller, Roberto; Tomé, Oliver; Wiest, Wolfgang; Maisch, Andrea; Nekljudova, Valentina; von Minckwitz, Gunter

    2011-12-01

    The combination of bendamustine (B) and paclitaxel (P) as anthracycline-free treatment option in patients with advanced breast cancer has been evaluated in the previous RiTa I trial. The regimen of weekly B 70 mg/m(2) and P 90 mg/m(2) with a pause every 4th week was established as an effective regimen with low toxicity. The aim of the present RiTa II study was to investigate the potential of BP as anthracycline-free combination therapy. The primary objective was to determine the progression-free survival (PFS); secondary endpoints were safety, tolerability, overall response rate (ORR) and overall survival (OS). 26 patients were available, 15 received BP as first-line, 11 as beyond first-line treatment. 27% patients had triple-negative breast cancer (TNBC). Median PFS and OS were 7.3 months (95% confidence interval (CI): 5.5-10.9) and 14.9 months (95% CI: 9.9-22.9), respectively. The 1-year PFS rate was 20.3% and the 1-year OS rate 71.2%. The ORR was 42.3%, including 4 complete and 7 partial remissions. TNBC patients reached an ORR of 71.4%. Anthracycline-pretreated patients showed an ORR of 43.8%, confirming bendamustine's lack of cross-resistance to anthracycline agents. BP represents a favorable option with moderate toxicity in pretreated metastatic breast cancer and offers a possibility for application in anthracycline-pretreated and TNBC patients.

  8. Absence of low back pain in patients followed weekly over one year with automated text messages

    DEFF Research Database (Denmark)

    Leboeuf-Yde, Charlotte; Jensen, Rikke K; Axén, Iben

    2012-01-01

    In order to define the onset of a new episode of low back pain (LBP), the definition of a "non-episode" must be clear. De Vet et al reviewed the scientific literature but found no evidence-based definitions of episodes or non-episodes of LBP. However, they suggested that pain-based episodes should...... be preceded and followed by a period of at least one month without LBP. As LBP is an episodic disease, it is not clear whether a sufficient number of patients with LBP will be LBP-free for at least one month ("non-episode") to justify the use of this duration in the definition of pain free episode....

  9. Granulocytic sarcoma in a patient with chronic myeloid leukaemia in complete haematological, cytogenetic and molecular remission.

    Science.gov (United States)

    Kittai, Adam; Yu, Eun-Mi; Tabbara, Imad

    2014-12-23

    Granulocytic sarcoma, also known as myeloid sarcoma, is an extramedullary tumour composed of immature myeloid cells. Granulocytic sarcoma is typically found in patients with acute myeloid leukaemia, accelerated phase or blast crisis of chronic myeloid leukaemia, myelodysplastic syndrome, or as an isolated event without bone marrow involvement. We present a case of granulocytic sarcoma in a patient with chronic myeloid leukaemia in the setting of complete haematological, molecular and cytogenetic remission. Our patient was first treated with imatinib for chronic-phase chronic myeloid leukaemia. After maintaining remission for 42 months, he developed a granulocytic sarcoma in his spine. In this case report, we describe our case, along with the three other cases reported in the literature. In addition to being a rare diagnosis, this case demonstrates the importance of being vigilant in diagnosing the cause of back pain and atypical symptoms in patients with a history of leukaemia. 2014 BMJ Publishing Group Ltd.

  10. Anakinra induces complete remission of nephrotic syndrome in a patient with familial mediterranean fever and amyloidosis.

    Science.gov (United States)

    Sevillano, Ángel M; Hernandez, Eduardo; Gonzalez, Esther; Mateo, Isabel; Gutierrez, Eduardo; Morales, Enrique; Praga, Manuel

    2016-01-01

    Renal amyloidosis is one of the most severe complications of familial Mediterranean fever (FMF). Colchicine has reduced the incidence of this complication, which now only appears in untreated, under-treated and resistant patients, but it is usually ineffective in patients with advanced amyloidosis. Here we report a patient with FMF and biopsy-proven amyloidosis who presented with nephrotic syndrome despite colchicine treatment. Anakinra (an interleukin-1β inhibitor) was started and a dramatic complete remission of nephrotic syndrome was observed in the following months. Anakinra can be an effective treatment for FMF patients with severe secondary amyloidosis. Copyright © 2015 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

  11. Cure of Helicobacter pylori-positive active duodenal ulcer patients: a double-blind, multicentre, 12-month study comparing a two-week dual vs a one-week triple therapy. GISU (Interdisciplinary Group for Ulcer Study).

    Science.gov (United States)

    Di Mario, F; Battaglia, F; Dal Bò, N; Leandro, G; Benedetti, E; Bottona, E; Caroli, A; Costan-Biedo, F; De Bastiani, R; Germanà, B; Andrea Grassi, S; Madia, D; Marcon, V; Marin, R; Monica, F; Olivieri, P; Orzes, N; Pilotto, A; Ronzani, G; Saggioro, A; Tafner, G

    2000-03-01

    To compare a two-week dual therapy to a one-week triple therapy for the healing of duodenal ulcer and the eradication of the Helicobacter pylori infection. A total of 165 patients with active duodenal ulcer were enrolled in the study. At entry, endoscopy, clinical examination and laboratory tests were performed. Histology and the rapid urease test were used to diagnose Helicobacter pylori infection. Patients received either lansoprazole 30 mg plus amoxycillin 1 g bid for two weeks (two-week, dual therapy) or lansoprazole 30 mg plus amoxycillin 1 g plus tinidazole 500 mg bid for one week plus lansoprazole qd for an additional week (one-week, triple therapy). Two and twelve months after cessation of therapy, endoscopy and clinical assessments were repeated. Duodenal ulcer healing and Helicobacter pylori eradication were both significantly greater (pcure rate: 72.6%) than in the dual therapy group (healing: 77.3%; Helicobacter pylori cure rate: 33.3%). Ulcers healed more frequently in Helicobacter pyloricured than in Helicobacter pylori-not cured patients (94.9% vs. 77.2%; pulcer relapses were observed throughout follow-up: all were in Helicobacter pylori-not cured patients. Triple therapy was more effective than dual both in curing Helicobacter pylori infection and healing active duodenal ulcers. The speed of ulcer healing obtained after only 7 days of antibiotics and 14 days of proton pump inhibitors confirmed that longer periods of anti ulcer therapy were not necessary. Helicobacter pylori -not cured patients had more slowly healing ulcers which were more apt to relapse when left untreated.

  12. Comparison of the outcomes of complete supine percutaneous nephrolithotomy in patients with radiopaque and radiolucent kidney stones.

    Science.gov (United States)

    Falahatkar, Siavash; Mokhtari, Gholamreza; Amin, Atiyeh; Kazemnezhad, Ehsan; Esmaeili, Samaneh; Herfeh, Nadia Rastjou; Falahatkar, Reza

    2017-12-01

    This study compared the stone opacity effect in patients who had radiopaque and radiolucent stones in percutaneous nephrolithotomy (PCNL) results. The medical records of 171 complete supine PCNL procedures were gathered. Patients were categorized into two groups: those with radiopaque (n=141) and those with radiolucent (n=30) stones. Kidney, ureter and bladder x-ray was done a day after PCNL and Ultrasound imaging was done two weeks later to evaluate the stone free rate. A stone free result was defined as having less than 4 mm residual stone size. Outcome parameters were compared by univariate analysis and those which were significantly different between the two groups were assessed by multivariate binary logistic regression analysis. There were no significant differences in age, sex, body mass index, hypertension, diabetes mellitus, pre-surgery hemoglobin, pre-surgery serum creatinine, stone and also surgery-related parameters between the two groups. Stone free rate, surgery time, complication-related parameters, hemoglobin drop, serum creatinine and glomerular filtration rate (GFR) changes were similar in both groups based on univariate analysis. The radiopaque group had higher post-surgery GFR (p=0.04) and longer hospital stay (p=0.009). However, opacity had no effect on these outcomes after multivariate analysis. Higher post-surgery GFR was seen in patient with higher GFR before surgery (p<0.0001). Also, higher hemoglobin before surgery was correlated with less hospital stay (p=0.001). The complete supine percutaneous nephrolithotomy outcomes are similar in patients with radiopaque and radiolucent stones.

  13. Effect of a 16 weeks weight loss program on osteoarthritis biomarkers in obese patients with knee osteoarthritis

    DEFF Research Database (Denmark)

    Bartels, Else Marie; Christensen, R; Christensen, Pia

    2014-01-01

    OBJECTIVE: Changes in biomarkers for bone and cartilage in knee osteoarthritis (KOA) may reflect changes in tissue turnover induced by interventions. The aim of this study was to assess the effect on osteoarthritis biomarkers of an intensive weight loss intervention in obese KOA patients. METHODS......: 192 obese KOA patients followed a 16 weeks weight loss intervention (ClinicalTrials.gov: NCT00655941). Serum Cartilage Oligomeric Matrix Protein (sCOMP), Urine C-terminal telopeptide of collagen type II (uCTX-II) and type I (uCTX-I) were determined by enzyme-linked immunoassay (ELISA) at baseline....../mmol creatinine, and correlated to weight loss (r = 0.22, P = 0.0007), while not to KOOS-4 (P = 0.93). CONCLUSION: A rapid substantial weight loss in obese KOA patients was weakly, while significantly associated with a reduction in sCOMP, and increases in both uCTX-II and uCTX-I....

  14. Selection of permanent pacing position of cardiac ventricle in patients with complete right bundle branch block

    International Nuclear Information System (INIS)

    Yang Minquan; Zhou Jun; Zhu Yan; Wang Jin; Rong Xin; Zhang Xiaoyi

    2005-01-01

    Objective: To find out the optimal pacing localization by comparing different pacing positions of the right ventricle in brady-cardiacarrhythmia patients with complete right bundle branch block. Methods: DDD type of double lumen permanent pacemaker was implanted in each of the 8 cases of sick sinus syndrome (SSS) and/or III degree atrioventricular block (III degree AVB) with complete right bundle branch block in normal heart function or class I. For each patient, four pacing positions in right ventricle were compared and the QRS pacing durations were recorded. The position with the shortest the QRS duration was chosen as the permanent pacing position. Heart function, chest X-rays and left ventricle ejection fraction (LVEF) were followed up after the operation. Results: In all the 8 cases, the posterior septum of the right ventricle were chosen as the permanent pacing position, with the shorter pacing QRS duration than that of pre-operation (P<0.05) and other pacing positions of the right ventricle. All parameters of this permanent pacing position were within the normal range. During the follow-up of 6-36 months, no abnormity was found in cardiac functions. Conclusion: In brady-cardiacarrhythmia patients with complete right bundle branch block, the implantation of permanent pacemaker should be at the junction region of inlet and outlet tracts, of the posterior septum of the right ventricle with ideal physiological function. (authors)

  15. Complete heart block in a patient with POEMS syndrome: A case report

    Directory of Open Access Journals (Sweden)

    Farzaneh Ashrafi

    2014-09-01

    Full Text Available BACKGROUND: Polyneuropathy, organomegaly, endocrinopathy, monoclonal syndrome (POEMS is a rare paraneoplastic syndrome associated with plasma cell dyscrasia. CASE REPORT: A 48-year-old man presented with a 1-year history of paresthesia and progressive weakness of extremities. Diagnosis of POEMS syndrome was made for him on the basis of clinical presentation, additional physical findings, typical sclerotic bone lesion, and bone marrow findings. In last admission, he explained episodes of dyspnea and chest pain that associated with frequent premature ventricular contraction in his electrocardiograph. Patient heart monitoring showed some episodes of complete heart block. Infra-His atrioventricular block in electro-physiologic study was detected. He had no history of ischemic heart disease. His cardiopulmonary findings on examination were normal. All results of cardiac biomarkers and serum electrolytes and repeated echocardiography were within normal range. Cong red staining of rectal fat pad biopsy was negative. After pacemaker insertion radiation of sclerotic bone, lesion started for him, but radiotherapy was ineffective, and he expired with respiratory failure. Complete heart block in POEMS syndrome has not been reported previously, and it is the first POEMS case with complete heart block. CONCLUSION: Complete heart block is a cardiac manifestation of POEMS syndrome.   Keywords: Complete Heart Block, POEM Syndrome, Multiple Meloma 

  16. Tipepidine in adolescent patients with depression: a 4 week, open-label, preliminary study

    Directory of Open Access Journals (Sweden)

    Sasaki T

    2014-05-01

    Full Text Available Tsuyoshi Sasaki,1,2 Kenji Hashimoto,3 Masumi Tachibana,1 Tsutomu Kurata,1 Hiroshi Kimura,2 Hideki Komatsu,2 Masatomo Ishikawa,2 Tadashi Hasegawa,2 Akihiro Shiina,1 Tasuku Hashimoto,2 Nobuhisa Kanahara,4 Tetsuya Shiraishi,2 Masaomi Iyo1–41Department 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, 4Division of Medical Treatment and Rehabilitation, Chiba University Center for Forensic Mental Health, Inohana, Chiba, JapanDepression in children and adolescents is a common, recurrent, and debilitating condition associated with increased psychosocial, and medical morbidity and mortality.1The global prevalence of depression in children and adolescents is 1%–2% and 3%–8%, respectively.2 Depressive symptoms are also associated with significant functional impairment in school and the work place (often requiring legal interventions,1–5 and an increased risk for substance abuse and suicide.6–9 Clinical guidelines suggest the use of two selective serotonin reuptake inhibitors (SSRI, namely fluoxetine and escitalopram, both of which are effective with generally acceptable safety profiles in the treatment of adolescent depression.10 Additionally, combination treatment with an SSRI and psychotherapy, typically cognitive behavioral therapy (CBT, has shown benefit in this cohort.10 However, caution is warranted since antidepressants therapy in children and adolescents is associated with increased rates of suicidal ideation11–13 and adverse effects, characterized by excessive emotional arousal or behavioral activation.14 These results highlight the need for new therapies in adolescent patients with depression, particularly therapies with fewer side effects.View original paper by Brent and Maalouf.

  17. Multisite prediction of 4-week and 52-week treatment outcomes in patients with first-episode psychosis: a machine learning approach

    NARCIS (Netherlands)

    Koutsouleris, Nikolaos; Kahn, René S.; Chekroud, Adam M.; Leucht, Stefan; Falkai, Peter; Wobrock, Thomas; Derks, Eske M.; Fleischhacker, Wolfgang W.; Hasan, Alkomiet

    2016-01-01

    Background At present, no tools exist to estimate objectively the risk of poor treatment outcomes in patients with first-episode psychosis. Such tools could improve treatment by informing clinical decision-making before the commencement of treatment. We tested whether such a tool could be

  18. Study protocol: non-displaced distal radial fractures in adult patients: three weeks vs. five weeks of cast immobilization: a randomized trial

    NARCIS (Netherlands)

    Bentohami, Abdelali; de Korte, Niels; Sosef, Nico; Goslings, Johan Carel; Bijlsma, Taco; Schep, Niels

    2014-01-01

    Up to 30% of patients suffer from long-term functional restrictions following conservative treatment of distal radius fractures. Whether duration of cast immobilisation influences functional outcome remains unclear. The aim of the study is to evaluate whether the duration of immobilization of non or

  19. Sensorimotor cortical activity in patients with complete spinal cord injury: a functional magnetic resonance imaging study.

    Science.gov (United States)

    Sabbah, P; de, Schonen S; Leveque, C; Gay, S; Pfefer, F; Nioche, C; Sarrazin, J L; Barouti, H; Tadie, M; Cordoliani, Y S

    2002-01-01

    Residual activation of the cortex was investigated in nine patients with complete spinal cord injury between T6 and L1 by functional magnetic resonance imaging (fMRI). Brain activations were recorded under four conditions: (1) a patient attempting to move his toes with flexion-extension, (2) a patient imagining the same movement, (3) passive proprio-somesthesic stimulation of the big toes without visual control, and (4) passive proprio-somesthesic stimulation of the big toes with visual control by the patient. Passive proprio-somesthesic stimulation of the toes generated activation posterior to the central sulcus in the three patients who also showed a somesthesic evoked potential response to somesthesic stimulation. When performed under visual control, activations were observed in two more patients. In all patients, activations were found in the cortical areas involved in motor control (i.e., primary sensorimotor cortex, premotor regions and supplementary motor area [SMA]) during attempts to move or mental imagery of these tasks. It is concluded that even several years after injury with some local cortical reorganization, activation of lower limb cortical networks can be generated either by the attempt to move, the mental evocation of the action, or the visual feedback of a passive proprio-somesthesic stimulation.

  20. The Effects of a 10-Week Water Aerobic Exercise on the Resting Blood Pressure in Patients with Essential Hypertension

    OpenAIRE

    Farahani, Ali Vasheghani; Mansournia, Mohammad-Ali; Asheri, Hossein; Fotouhi, Akbar; Yunesian, Masud; Jamali, Mohsen; Ziaee, Vahid

    2010-01-01

    Purpose To investigate the effects of a 10-week water aerobic exercise on the resting blood pressure in patients with stage 1 or 2 hypertension referring to Tehran University Clinics. Methods Forty men with stage 1 or 2 essential hypertension were assigned to two groups of intervention [n = 12; aged 48.33±10.74 years (mean±SD)] and control [n = 28; aged 46.96±11.58 years (mean±SD)]. Subjects in the intervention group participated ...

  1. Real-world experiences of folic acid supplementation (5 versus 30 mg/week with methotrexate in rheumatoid arthritis patients: a comparison study

    Directory of Open Access Journals (Sweden)

    K.T. Koh

    2016-09-01

    Full Text Available The objective of this study was to compare the tolerability of methotrexate in two different regimes of folic acid (FA supplementation in rheumatoid arthritis (RA. We performed a multicenter, cross-sectional observational cohort study on 240 RA patients with 120 patients each in 5 mg of FA weekly and 30 mg of FA weekly supplementation. There were no significant differences for side effects (14.2 versus 22.5%, P=0.523 and discontinuation of methotrexate (3.6 versus 13.3%, P=0.085. RA patients given 5 mg of FA weekly supplementation had a lower disease activity score 28 compared to 30 mg of FA weekly supplementation [3.44 (1.10 versus 3.85 (1.40, P=0.014]. FA supplementation of 5 mg per week and 30 mg per week was associated with similar tolerability of methotrexate in RA patients.

  2. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes.

    Science.gov (United States)

    Wysham, Carol H; Rosenstock, Julio; Vetter, Marion L; Dong, Fang; Öhman, Peter; Iqbal, Nayyar

    2018-01-01

    To simplify administration of aqueous exenatide once weekly, which requires reconstitution, the exenatide microspheres have been reformulated in a ready-to-use autoinjector with a Miglyol diluent (exenatide QWS-AI). This study compared the efficacy and safety of exenatide QWS-AI with the first-in-class glucagon-like peptide-1 receptor agonist exenatide twice daily (BID). This randomized, open-label, controlled study in patients with type 2 diabetes using diet and exercise or taking stable oral glucose-lowering medication randomized patients 3:2 to either exenatide QWS-AI (2 mg) or exenatide BID (10 μg) for 28 weeks. The primary outcome was the 28-week change in glycated haemoglobin (HbA1c). A subset of patients completed a standardized meal test for postprandial and pharmacokinetic assessments. A total of 375 patients (mean HbA1c, 8.5% [69 mmol/mol]; body mass index, 33.2 kg/m 2 ; diabetes duration, 8.5 years) received either exenatide QWS-AI (n = 229) or exenatide BID (n = 146); HbA1c was reduced by -1.4% and -1.0%, respectively (least-squares mean difference, -0.37%; P = .0072). More patients achieved HbA1c <7.0% with exenatide QWS-AI (49.3%) than with exenatide BID (43.2%; P = .225). Body weight was reduced in both groups (P = .37 for difference). Gastrointestinal adverse events (AEs) were reported in 22.7% (exenatide QWS-AI) and 35.6% (exenatide BID) of patients; fewer patients in the exenatide QWS-AI group withdrew because of AEs than in the exenatide BID group. Minor hypoglycaemia occurred most often with concomitant sulfonylurea use. Exenatide QWS-AI was associated with a greater reduction in HbA1c, similar weight loss and a favorable gastrointestinal AE profile compared with exenatide BID. © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  3. 96 Week Follow-Up of HIV-Infected Patients in Rescue with Raltegravir Plus Optimized Backbone Regimens: A Multicentre Italian Experience

    OpenAIRE

    Capetti, Amedeo; Landonio, Simona; Meraviglia, Paola; Di Biagio, Antonio; Lo Caputo, Sergio; Sterrantino, Gaetana; Ammassari, Adriana; Menzaghi, Barbara; Franzetti, Marco; De Socio, Giuseppe Vittorio; Pellicanò, Giovanni; Mazzotta, Elena; Soria, Alessandro; Meschiari, Marianna; Trezzi, Michele

    2012-01-01

    BACKGROUND: Long term efficacy of raltegravir (RAL)-including regimens in highly pre-treated HIV-1-infected patients has been demonstrated in registration trials. However, few studies have assessed durability in routine clinical settings. METHODS: Antiretroviral treatment-experienced patients initiating a RAL-containing salvage regimen were enrolled. Routine clinical and laboratory follow-up was performed at baseline, week 4, 12, and every 12 weeks thereafter. Data were censored at week 96. R...

  4. Risk of self-harm and nonfatal suicide attempts, and completed suicide in patients with psoriasis

    DEFF Research Database (Denmark)

    Egeberg, A; Hansen, P. R.; Gislason, G. H.

    2016-01-01

    Background: Psoriasis is a common inflammatory skin disease, and inflammation may affect suicidal behaviour. Current data on the incidence and risk of suicidal behaviour in patients with psoriasis are scarce. Objectives: We investigated the association between psoriasis and the risk of self......-harm and suicide attempts and suicides. Methods: All Danish patients aged ≥ 18 years with mild or severe psoriasis (cases) from 1 January 1997 to 31 December 2011 were matched on age, sex and calendar time 1 : 5 with healthy controls. The outcome was a diagnosis of self-harm or a nonfatal suicide attempt......, or completed suicide. Incidence rates per 10 000 person-years were calculated, and incidence rate ratios (IRRs) and confidence intervals (CIs) were estimated by Poisson regression models. Results: The study cohort comprised 408 663 individuals, including 57 502 and 11 009 patients with mild and severe...

  5. Sectional mandibular complete denture for a total maxillectomy patient with trismus: a clinical report.

    Science.gov (United States)

    Celakil, Tamer; Demir, Azize; Keskin, Haluk

    2017-01-01

    This report presents the case of a 60-year-old male patient with trismus induced by radiotherapy and fabrication of a sectional mandibular complete denture to allow the insertion of the denture into the mouth. A mandibular sectional denture was designed in two pieces with a locking mechanism by using mini anchor and ball abutment housing with cap. Patients who have undergone maxillectomy often have constricted mouth openings, as a result of surgical intervention and radiotherapy, and complain of an inability to insert or remove dentures. A new approach is vital for sectional dentures because existing sectional denture fabrication techniques cannot meet the ongoing needs of trismus patients. The mini anchor system with ball abutment housing has better mechanical retention in acrylic resin and can provide favorable stabilization during masticatory function; thus, additional framework is not required for assisting in stabilization and retention.

  6. SECTIONAL MANDIBULAR COMPLETE DENTURE FOR A TOTAL MAXILLECTOMY PATIENT WITH TRISMUS: A CLINICAL REPORT

    Directory of Open Access Journals (Sweden)

    Tamer ÇELAKIL

    2017-10-01

    Full Text Available This report presents the case of a 60-year-old male patient with trismus induced by radiotherapy and fabrication of a sectional mandibular complete denture to allow the insertion of the denture into the mouth. A mandibular sectional denture was designed in two pieces with a locking mechanism by using mini anchor and ball abutment housing with cap. Patients who have undergone maxillectomy often have constricted mouth openings, as a result of surgical intervention and radiotherapy, and complain of an inability to insert or remove dentures. A new approach is vital for sectional dentures because existing sectional denture fabrication techniques cannot meet the ongoing needs of trismus patients. The mini anchor system with ball abutment housing has better mechanical retention in acrylic resin and can provide favorable stabilization during masticatory function; thus, additional framework is not required for assisting in stabilization and retention.

  7. Anorectal function in patients with complete rectal prolapse. Differences between continent and incontinent individuals.

    Science.gov (United States)

    Roig, J V; Buch, E; Alós, R; Solana, A; Fernández, C; Villoslada, C; García-Armengol, J; Hinojosa, J

    1998-11-01

    A study is made of the alterations in anorectal physiology among rectal prolapse patients, evaluating the differences between fecal continent and incontinent individuals. Eighteen patients with complete rectal prolapse were divided into two groups: Group A (8 continent individuals) and Group B (10 incontinent women), while 22 healthy women were used as controls (Group C). Clinical exploration and perineal level measurements were performed, along with anorectal manometry, electrophysiology, and anorectal sensitivity to electrical stimuli. The main antecedents of the continent subjects were excess straining efforts, while the incontinent women presented excess straining and complex deliveries. Pathological perineal descent was a frequent finding in both groups, with a hypotonic anal canal at rest (p rest than the continent women (p rest, regardless of whether they are continent to feces or not. Continent patients have less pudendal neuropathy and therefore less pressure alterations at voluntary sphincter squeeze than incontinent individuals.

  8. The effects of three-week fasting diet on blood pressure, lipid profile and glucoregulation in extremely obese patients

    Directory of Open Access Journals (Sweden)

    Beleslin Biljana

    2007-01-01

    Full Text Available Introduction Obesity is often accompanied by a number of complications including diabetes mellitus and cardiovascular diseases. Elevated blood pressure and lipids, as well as deterioration of glucoregulation are attributed, as the most significant factors, to development of diabetes mellitus and cardiovascular complications in obese patients. Objective The aim of our study was to evaluate the effects of a fasting diet on blood pressure, lipid profile and glucoregulatory parameters. Method We included 110 patients (33 male and 77 female; mean age 35±1 years, body weight 131.7±2.6 kg, body mass index 45.4±0.8 kg/m2 who were hospitalized for three weeks for the treatment of extreme obesity with the fasting diet. At the beginning, during, and at the end of this period, we evaluated changes in blood pressure, lipid profile, as well as parameters of glucoregulation including glycaemia, insulinaemia, and insulin sensitivity by HOMA. Oral glucose tolerance test (OGTT was performed in all patients at the beginning and at the end of the fasting diet. Results During the fasting diet, the body weight decreased from 131.7±2.6 kg to 117.7±2.4 kg (p<0.001, the body mass index decreased from 45.4±0.8 kg/m2 to 40.8±0.8 kg/m2 (p<0.001, and both systolic and diastolic blood pressure significantly declined (143±2 vs. 132±2 mm Hg, p<0.001; 92±2 vs. 85±2 mm Hg, p<0.001. In addition, the fasting diet produced a significant decrease in total cholesterol, LDL cholesterol, triglycerides, as well as basal glycaemia and insulinaemia (p<0.001 Before the fasting diet, OGTT was normal in 76% of patients, whereas 21% of patients showed glucose intolerance, and 4% of patients diabetes mellitus. After the fasting diet, OGTT was normal in 88% of patients, whereas 12% of patients still had signs of glucose intolerance (p<0.05. In addition, insulin resistance significantly (p<0.05 increased from 54±6% to 89±13% after the fasting diet. Conclusion The three-week fasting

  9. Impact of patient questionnaires on completeness of clinical information and identification of causes of pain during outpatient abdominopelvic CT interpretation.

    Science.gov (United States)

    Doshi, Ankur M; Huang, Chenchan; Ginocchio, Luke; Shanbhogue, Krishna; Rosenkrantz, Andrew B

    2017-12-01

    To evaluate the impact of questionnaires completed by patients at the time of abdominopelvic CT performed for abdominal pain on the completeness of clinical information and the identification of potential causes of pain, compared with order requisitions alone. 100 outpatient CT examinations performed for the evaluation of abdominal pain were retrospectively reviewed. The specificity of the location of pain was compared between the order requisition and patient questionnaire. An abdominal imaging fellow (Reader 1) and abdominal radiologist (Reader 2) reviewed the examinations independently in two sessions 6 weeks apart (one with only the order requisition and one also with the questionnaire). Readers recorded identified causes of pain and rated their confidence in interpretation (1-5 scale; least to greatest confidence). In 30% of patients, the questionnaire provided a more specific location for pain. Among these, the pain was localized to a specific quadrant in 40%. With having access to the questionnaire, both readers identified additional causes for pain not identified in session 1 (Reader 1, 8.6% [7/81]; Reader 2 5.3% [4/75]). Additional identified causes of pain included diverticulitis, cystitis, peritoneal implants, epiploic appendagitis, osseous metastatic disease, umbilical hernia, gastritis, and SMA syndrome. Confidence in interpretation was significantly greater using the questionnaire for both readers (Reader 1: 4.8 ± 0.6 vs. 4.0 ± 0.5; Reader 2: 4.9 ± 0.3 vs. 4.7 ± 0.5, p questionnaires provide additional relevant clinical history, increased diagnostic yield, and improve radiologists' confidence. Radiology practices are encouraged to implement questionnaires and make these readily available to radiologists at the time of interpretation.

  10. Umbilical KeyPort bilateral laparoscopic orchiectomy in patient with complete androgen insensitivity syndrome

    Directory of Open Access Journals (Sweden)

    Felipe P. Andrade

    2012-10-01

    Full Text Available MAIN FINDINGS: A 22-year-old woman with complete androgen insensitivity syndrome (CAIS presenting with primary amenorrhea and normal female external genitalia was referred for laparoscopic gonadectomy. She had been diagnosed several years earlier but was reluctant to undergo surgery. CASE HYPOTHESIS: Diagnosis of this X-linked recessive inherited syndrome characterizes by disturbance of virilization in males with an AR mutation, XY karyotipe, female genitalia and severely undescended testis with risk of malignization. The optimal time to orchidectomy is not settled; neither the real risk of malignancy in these patients. Early surgery impacts development of a complete female phenotype, with enlargement of the breasts. Based on modern diagnostic imaging using DCE-MRI and surgical technology with single port laparoscopic access we hypothesize that the optimum time for gonadectomy is not at the time of diagnosis, but once feminization has completed. PROMISING FUTURE IMPLICATIONS: An umbilical laparoendoscopic single-site access for bilateral gonadectomy appears to be the first choice approach as leaves no visible incision and diminishes the psychological impact of surgery in a patient with CAIS absolutely reassured as female. KeyPort, a single port access with duo-rotate instruments developed by Richard Wolf facilitates this surgery and allows excellent cosmetic results.

  11. 3-D shape analysis of palatal surface in patients with unilateral complete cleft lip and palate.

    Science.gov (United States)

    Rusková, Hana; Bejdová, Sárka; Peterka, Miroslav; Krajíček, Václav; Velemínská, Jana

    2014-07-01

    Facial development of patients with unilateral complete cleft lip and palate (UCLP) is associated with many problems including deformity of the palate. The aim of this study was to evaluate palatal morphology and variability in patients with UCLP compared with Czech norms using methods of geometric morphometrics. The study was based on virtual dental cast analysis of 29 UCLP patients and 29 control individuals at the age of 15 years. The variability of palatal shape in UCLP patients was greater than that in nonclefted palates. Only 24% of clefted palates fell within the variability of controls. The palatal form of UCLP patients (range from 11.8 to 17.2 years) was not correlated with age. Compared with control palates, palates of UCLP patients were narrower, more anteriorly than posteriorly. Apart from the praemaxilla region, they were also shallower, and the difference increased posteriorly. The UCLP palate was characterised by the asymmetry of its vault. The maximum height of the palatal vault was anterior on the clefted side, whereas it was posterior on the nonclefted side. The slope of the UCLP palate was more inclined compared with the control group. The praemaxilla was therefore situated more inferiorly. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  12. Agomelatine for the treatment of patients with fibromyalgia and depressive symptomatology: an uncontrolled, 12-week, pilot study.

    Science.gov (United States)

    Calandre, E P; Slim, M; Garcia-Leiva, J M; Rodriguez-Lopez, C M; Torres, P; Rico-Villademoros, F

    2014-03-01

    Agomelatine, a melatonin agonist and selective 5-HT2C antagonist, is a novel antidepressant with sleep-enhancing properties. The purpose of this study was to assess the efficacy and tolerability of agomelatine among patients with fibromyalgia and depression. 23 patients with fibromyalgia and depressive symptomatology received 25-50 mg of agomelatine daily for 12 weeks. The primary outcome measure was the change of the Beck depression inventory score. Secondary outcome measures included the hospital anxiety and depression scale, Pittsburgh sleep quality index, Fibromyalgia Impact Questionnaire, short-form health survey, brief pain inventory and patient's global impression scale. Agomelatine significantly improved depression, global fibromyalgia severity and pain intensity but effect sizes were small. No improvement was seen in sleep quality. Patients categorized as responders to treatment had milder disease severity than non-responders. Agomelatine therapy was well tolerated and patients only reported mild and transient side effects. Agomelatine slightly improved depressive and fibromyalgia symptomatology but did not improve sleep quality. Our data do not support agomelatine as a first-line treatment option for the treatment of fibromyalgia and depression. © Georg Thieme Verlag KG Stuttgart · New York.

  13. Exercise capacity before and after an 8-week multidisciplinary inpatient rehabilitation program in lung cancer patients: a pilot study.

    Science.gov (United States)

    Spruit, Martijn A; Janssen, Paul P; Willemsen, Sonja C P; Hochstenbag, Monique M H; Wouters, Emiel F M

    2006-05-01

    Although lung cancer is a highly prevalent type of cancer, the effects of an inpatient multidisciplinary rehabilitation program on pulmonary function and exercise capacity have never been studied in these patients. Pulmonary function, 6-min walking distance and peak exercise capacity of 10 patients with a severely impaired pulmonary function following treatment of lung cancer were assessed in this pilot study before and after an 8-week inpatient multidisciplinary rehabilitation program. At baseline, patients had a restrictive pulmonary function and an apparent exercise intolerance (median 6-min walking distance: 63.6% predicted; median peak cycling load: 58.5% predicted). Despite the lack of change in median pulmonary function [FEV1: -0.01L, p = 0.5469], functional exercise capacity [145 m; 43.2% of the initial values, p=0.0020] and peak exercise capacity [26 W; 34.4% of the initial values, p = 0.0078] improved significantly compared to baseline. Future trials have to corroborate the present findings. Nevertheless, patients with lung cancer have a clear indication to start a comprehensive rehabilitation program following intensive treatment of their disease. In fact, based on the results of the present pilot study it appears that these patients are good candidates for pulmonary rehabilitation programs.

  14. Physical activity and health-related quality of life in pediatric cancer patients following a 4-week inpatient rehabilitation program.

    Science.gov (United States)

    Müller, Carsten; Krauth, Konstantin A; Gerß, Joachim; Rosenbaum, Dieter

    2016-09-01

    Chronic health conditions and impaired quality of life are commonly experienced in childhood cancer survivors. While rehabilitation clinics support patients in coping with the disease, studies evaluating an inpatient rehabilitation program on promoting physical activity (PA) and health-related quality of life (HRQoL) are missing. A 4-week inpatient rehabilitation program was prospectively evaluated. One hundred fifty patients with leukemia or lymphoma (N = 86), brain tumors (N = 38), and sarcomas (N = 26) were enrolled on average 17 months after cessation of acute medical treatment. PA amount and cadence (indicating the intensity of walking activity) using the StepWatch™ 3 Activity Monitor and HRQoL global and physical well-being scores using the KINDL(®) questionnaire were assessed before, immediately after, and 6 and 12 months following the program and analyzed using multiple linear mixed models. Significant effects on PA were only found at 12-month follow-up for amount and cadence variables (all p patients revealed the highest PA level throughout the study, rehabilitation effects were more pronounced for cadence variables in brain tumor and sarcoma patients. The rehabilitation program had immediate (t = 4.56, p cancer patients.

  15. Diagnosis and treatment of orofacial pain in a patient with unserviceable complete dentures: A clinical report.

    Science.gov (United States)

    Selecman, Audrey M; Ahuja, Swati A

    2018-02-08

    An ill-fitting complete denture has the potential to create pain and discomfort as well as conceal or confound the diagnosis of other primary sources of orofacial pain such as trigeminal neuralgia. Guidelines of the American Academy of Orofacial Pain offer an evidence-based approach for the assessment, diagnosis, and management of orofacial pain. A complete and accurate differential diagnosis is paramount to the success of treatment as well as to the circumvention of unnecessary therapy. The purpose of this clinical report was to emphasize an evidence-based approach to the diagnosis and treatment of orofacial pain in a patient with edentulism and a history of prolonged denture wear. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  16. Imaging technique for the complete edentulous patient treated conventionally or with mini implant overdenture

    Science.gov (United States)

    Meleşcanu Imre, M; Preoteasa, E; Țâncu, AM; Preoteasa, CT

    2013-01-01

    Rationale. The imaging methods are more and more used in the clinical process of modern dentistry. Once the implant based treatment alternatives are nowadays seen as being the standard of care in edentulous patients, these techniques must be integrated in the complete denture treatment. Aim. The study presents some evaluation techniques for the edentulous patient treated by conventional dentures or mini dental implants (mini SKY Bredent) overdentures, using the profile teleradiography. These offer data useful for an optimal positioning of the artificial teeth and the mini dental implants, favoring to obtain an esthetic and functional treatment outcome. We proposed also a method to conceive a simple surgical guide that allows the prosthetically driven implants placement. Material and method. Clinical case reports were made, highlighting the importance of cephalometric evaluation on lateral teleradiographs in complete edentulous patients. A clinical case that gradually reports the surgical guide preparation (Bredent silicon radio opaque), in order to place the mini dental implants in the best prosthetic and anatomic conditions, was presented. Conclusions. The profile teleradiograph is a useful tool for the practitioner. It allows establishing the optimal site for implant placement, in a good relation with the overdenture. The conventional denture can be easily and relatively costless transformed in a surgical guide used during implant placement. PMID:23599828

  17. Occlusal designs on masticatory ability and patient satisfaction with complete denture: a systematic review.

    Science.gov (United States)

    Zhao, Ke; Mai, Qing-Qing; Wang, Xiao-Dong; Yang, Wen; Zhao, Li

    2013-11-01

    To systematically review clinical outcomes of different occlusal designs of complete dentures. Using a various key words, an electronic search of clinical trials published in English and Chinese literature was performed from four databases: Medline/PubMed, EMBASE, Cochrane Library, and CBM. Furthermore, a manual searching of the relevant journals and the bibliographies of reviews was performed. General satisfaction, masticatory ability, retention, and stability were major criteria for the evaluation of the outcomes. Studies met these criteria were selected for a full-text reading. The whole processes were performed by two reviewers independently. This systematic review started with 1030 articles, which were finally narrowed down to seven, according to the inclusion criteria. The following occlusal designs were included and analyzed: anatomic occlusion, balanced occlusion, canine guidance occlusion, lingualized occlusion, monoplane occlusion, and bilateral-balanced and canine-guided design. Three of the seven studies showed that lingualized occlusion had ratings of higher patients' satisfaction than other occlusion designs. On the other hand, the canine-guided occlusion dentures demonstrated equal or better clinical performances than bilateral-balanced dentures. Because of the heterogeneity and bias of the studies, it was not possible to analyze the data statistically. Lingualized occlusion and canine-guided occlusion can be successfully applied in the fabrication of complete dentures. Canine guided occlusion has also been shown to be satisfactory. More well-controlled randomized trials are needed regarding canine-guided occlusion and the relationship between alveolar ridge resorption, different occlusal schemes and patient satisfaction. The conventional prosthodontic wisdom that complete dentures require a balanced occlusal design is not supported by the included literature. A suitable occlusal scheme would be a critical factor for a successful complete denture

  18. Development and Analysis of Patient-Based Complete Conducting Airways Models.

    Directory of Open Access Journals (Sweden)

    Rafel Bordas

    Full Text Available The analysis of high-resolution computed tomography (CT images of the lung is dependent on inter-subject differences in airway geometry. The application of computational models in understanding the significance of these differences has previously been shown to be a useful tool in biomedical research. Studies using image-based geometries alone are limited to the analysis of the central airways, down to generation 6-10, as other airways are not visible on high-resolution CT. However, airways distal to this, often termed the small airways, are known to play a crucial role in common airway diseases such as asthma and chronic obstructive pulmonary disease (COPD. Other studies have incorporated an algorithmic approach to extrapolate CT segmented airways in order to obtain a complete conducting airway tree down to the level of the acinus. These models have typically been used for mechanistic studies, but also have the potential to be used in a patient-specific setting. In the current study, an image analysis and modelling pipeline was developed and applied to a number of healthy (n = 11 and asthmatic (n = 24 CT patient scans to produce complete patient-based airway models to the acinar level (mean terminal generation 15.8 ± 0.47. The resulting models are analysed in terms of morphometric properties and seen to be consistent with previous work. A number of global clinical lung function measures are compared to resistance predictions in the models to assess their suitability for use in a patient-specific setting. We show a significant difference (p < 0.01 in airways resistance at all tested flow rates in complete airway trees built using CT data from severe asthmatics (GINA 3-5 versus healthy subjects. Further, model predictions of airways resistance at all flow rates are shown to correlate with patient forced expiratory volume in one second (FEV1 (Spearman ρ = -0.65, p < 0.001 and, at low flow rates (0.00017 L/s, FEV1 over forced vital capacity (FEV1

  19. Phase II Study Evaluating the Addition of Cetuximab to the Concurrent Delivery of Weekly Carboplatin, Paclitaxel, and Daily Radiotherapy for Patients With Locally Advanced Squamous Cell Carcinomas of the Head and Neck

    Energy Technology Data Exchange (ETDEWEB)

    Suntharalingam, Mohan, E-mail: msuntha@umm.edu [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD (United States); Kwok, Young [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD (United States); Goloubeva, Olga [University of Maryland Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, MD (United States); Parekh, Arti [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD (United States); Taylor, Rodney; Wolf, Jeffrey [Department of Otorhinolaryngology, University of Maryland School of Medicine, Baltimore, MD (United States); Zimrin, Ann [University of Maryland Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, MD (United States); Strome, Scott [Department of Otorhinolaryngology, University of Maryland School of Medicine, Baltimore, MD (United States); Ord, Robert [Department of Oral-Maxillo Facial Surgery, University of Maryland School of Medicine, Baltimore, MD (United States); Cullen, Kevin J. [University of Maryland Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, MD (United States)

    2012-04-01

    Purpose: To report the mature data of a prospective Phase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT). Methods and Materials: From 2005 to 2009, a total of 43 patients were enrolled in the study. The median follow-up was 31 months (range, 9-59 months). All patients had Stage III/IV disease at presentation, and 67% had oropharyngeal primaries. The weekly IV dose schedules were CTX 250 mg/m{sup 2} (400 mg/m{sup 2} IV loading dose 1 week before RT), paclitaxel 40 mg/m{sup 2}, and carboplatin AUC 2. RT was given at 1.8 Gy per day to 70.2 Gy. Intensity-modulated RTwas used in 70% of cases. Results: All patients completed the planned RT dose, 74% without any treatment breaks. The planned CTX and PC cycles were completed in 70% (91% with at least seven of planned nine cycles) and 56% (93% with at least seven of planned eight cycles) of patients, respectively. Toxicity included Grade 3 mucositis (79%), rash (9%), leucopenia (19%), neutropenia (19%), and RT dermatitis (16%). The complete response (CR) rate at the completion of therapy was 84%. The estimated 3-year local regional control rate was 72%. Six patients with an initial CR subsequently experienced a local recurrence, 10 patients experienced distant progression. The median overall survival and disease-free survivals have not been reached. The 3-year actuarial overall survival and disease-free survival were 59% and 58%, respectively. Conclusions: The addition of CTX to weekly PC and daily RT was well tolerated and resulted in encouraging local control and survival rates.

  20. Phase II Study Evaluating the Addition of Cetuximab to the Concurrent Delivery of Weekly Carboplatin, Paclitaxel, and Daily Radiotherapy for Patients With Locally Advanced Squamous Cell Carcinomas of the Head and Neck

    International Nuclear Information System (INIS)

    Suntharalingam, Mohan; Kwok, Young; Goloubeva, Olga; Parekh, Arti; Taylor, Rodney; Wolf, Jeffrey; Zimrin, Ann; Strome, Scott; Ord, Robert; Cullen, Kevin J.

    2012-01-01

    Purpose: To report the mature data of a prospective Phase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT). Methods and Materials: From 2005 to 2009, a total of 43 patients were enrolled in the study. The median follow-up was 31 months (range, 9–59 months). All patients had Stage III/IV disease at presentation, and 67% had oropharyngeal primaries. The weekly IV dose schedules were CTX 250 mg/m 2 (400 mg/m 2 IV loading dose 1 week before RT), paclitaxel 40 mg/m 2 , and carboplatin AUC 2. RT was given at 1.8 Gy per day to 70.2 Gy. Intensity-modulated RTwas used in 70% of cases. Results: All patients completed the planned RT dose, 74% without any treatment breaks. The planned CTX and PC cycles were completed in 70% (91% with at least seven of planned nine cycles) and 56% (93% with at least seven of planned eight cycles) of patients, respectively. Toxicity included Grade 3 mucositis (79%), rash (9%), leucopenia (19%), neutropenia (19%), and RT dermatitis (16%). The complete response (CR) rate at the completion of therapy was 84%. The estimated 3-year local regional control rate was 72%. Six patients with an initial CR subsequently experienced a local recurrence, 10 patients experienced distant progression. The median overall survival and disease-free survivals have not been reached. The 3-year actuarial overall survival and disease-free survival were 59% and 58%, respectively. Conclusions: The addition of CTX to weekly PC and daily RT was well tolerated and resulted in encouraging local control and survival rates.

  1. Discrimination of Motor Imagery-Induced EEG Patterns in Patients with Complete Spinal Cord Injury

    Directory of Open Access Journals (Sweden)

    G. Pfurtscheller

    2009-01-01

    Full Text Available EEG-based discrimination between different motor imagery states has been subject of a number of studies in healthy subjects. We investigated the EEG of 15 patients with complete spinal cord injury during imagined right hand, left hand, and feet movements. In detail we studied pair-wise discrimination functions between the 3 types of motor imagery. The following classification accuracies (mean ± SD were obtained: left versus right hand 65.03% ± 8.52, left hand versus feet 68.19% ± 11.08, and right hand versus feet 65.05% ± 9.25. In 5 out of 8 paralegic patients, the discrimination accuracy was greater than 70% but in only 1 out of 7 tetraplagic patients. The present findings provide evidence that in the majority of paraplegic patients an EEG-based BCI could achieve satisfied results. In tetraplegic patients, however, it is expected that extensive training-sessions are necessary to achieve a good BCI performance at least in some subjects.

  2. Value of platelet indices in identifying complete resolution of thrombus in deep venous thrombosis patients.

    Science.gov (United States)

    Sevuk, Utkan; Altindag, Rojhat; Bahadir, Mehmet Veysi; Ay, Nurettin; Demirtas, Ertan; Ayaz, Fırat

    2015-03-01

    We aimed to evaluate whether mean platelet volume (MPV) and platelet distribution width (PDW) are helpful to identify complete thrombus resolution (CTR) after acute deep venous thrombosis (DVT). Patients who had first-time episode of acute proximal DVT were included in this retrospective study. 100 patients with DVT were divided into two groups according to absence (group 1; n = 68) or presence (group 2; n = 32) of CTR on doppler ultrasonography at month 6. There were no significant difference in admission MPV and PDW levels between group 1 and group 2. MPV (p = 0.03) and PDW (p venous thrombosis in DVT patients. Receiver operating characteristics analysis revealed that a 8.4 % decrease in admission MPV at month 6 provided 62 % sensitivity and 62 % specificity (AUC: 0.64) and a 15.4 % decrease in admission PDW at month 6 provided 87 % sensitivity and 94 % specificity (AUC: 0.89) for prediction of CTR in DVT patients. Percent change in admission MPV and PDW levels at month 6 may be used to identify the patients with CTR after a first episode of acute proximal DVT.

  3. Effect of 1-week yoga-based residential program on cardiovascular variables of hypertensive patients: A Comparative Study

    Directory of Open Access Journals (Sweden)

    Kashinath G Metri

    2018-01-01

    Full Text Available Introduction: Hypertension (HTN is an important public health concern and a leading cause of morbidity and mortality worldwide. Yoga is a form of mind–body medicine shown to be effective in controlling blood pressure (BP and reduces cardiac risk factors in HTN. Integrated approach of Yoga therapy (IAYT is a residential yoga-based lifestyle intervention proven to be beneficial in several health conditions. Aim: To study the efficacy of 1 week of residential IAYT intervention on cardiovascular parameters in hypertensive patients. Methodology: Twenty hypertensive individuals (7 females within age range between 30 and 60 years (average; 46.62 ± 9.9 years, who underwent 1 week of IAYT treatment for HTN, were compared with age- gender-matched non-IAYT group (5 females; average age; 47.08 ± 9.69 years in terms of systolic BP (SBP, diastolic BP (DBP, mean arterial pressure (MAP, cardiac output (CO, stroke volume (SV, baroreflex sensitivity (BRS, and total peripheral vascular resistance (TPVR, IAYT program consisted of sessions of asanas, breathing practices, meditation and relaxation techniques, low salt, low-calorie diet, devotional session, and counseling. Individuals in non-IAYT group followed their normal routine. All the variables were assessed before and after one week. Data were analyzed using SPSS version 16. RM-ANOVA was applied to assess within group and between group changes after intervention. Results: There was a significant improvement in SBP (P = 0.004, DBP (P = 0.008, MAP (0.03, BRS (P < 0.001, and TPVR (P = 0.007 in IAYT, group whereas in control group, we did not find significant difference in any of the variables. Between-group comparison showed a significant improvement in SBP (P = 0.038, BRS (P = 0.034, and TPVR (P = 0.015 in IAYT group as compared to non-IAYT group. Conclusion: One-week IAYT intervention showed an improvement in baroreflex sensitivity, systolic BP, and total peripheral vascular resistance in hypertensive

  4. Effect of 1-Week Yoga-Based Residential Program on Cardiovascular Variables of Hypertensive Patients: A Comparative Study.

    Science.gov (United States)

    Metri, Kashinath G; Pradhan, Balaram; Singh, Amit; Nagendra, H R

    2018-01-01

    Hypertension (HTN) is an important public health concern and a leading cause of morbidity and mortality worldwide. Yoga is a form of mind-body medicine shown to be effective in controlling blood pressure (BP) and reduces cardiac risk factors in HTN. Integrated approach of Yoga therapy (IAYT) is a residential yoga-based lifestyle intervention proven to be beneficial in several health conditions. Aim: To study the efficacy of 1 week of residential IAYT intervention on cardiovascular parameters in hypertensive patients. Twenty hypertensive individuals (7 females) within age range between 30 and 60 years (average; 46.62 ± 9.9 years), who underwent 1 week of IAYT treatment for HTN, were compared with age- gender-matched non-IAYT group (5 females; average age; 47.08 ± 9.69 years) in terms of systolic BP (SBP), diastolic BP (DBP), mean arterial pressure (MAP), cardiac output (CO), stroke volume (SV), baroreflex sensitivity (BRS), and total peripheral vascular resistance (TPVR), IAYT program consisted of sessions of asanas, breathing practices, meditation and relaxation techniques, low salt, low-calorie diet, devotional session, and counseling. Individuals in non-IAYT group followed their normal routine. All the variables were assessed before and after one week. Data were analyzed using SPSS version 16. RM-ANOVA was applied to assess within group and between group changes after intervention. There was a significant improvement in SBP ( P = 0.004), DBP ( P = 0.008), MAP (0.03), BRS ( P < 0.001), and TPVR ( P = 0.007) in IAYT, group whereas in control group, we did not find significant difference in any of the variables. Between-group comparison showed a significant improvement in SBP ( P = 0.038), BRS ( P = 0.034), and TPVR ( P = 0.015) in IAYT group as compared to non-IAYT group. One-week IAYT intervention showed an improvement in baroreflex sensitivity, systolic BP, and total peripheral vascular resistance in hypertensive patients. However, further randomized control

  5. [A case showing a complete response by weekly paclitaxel associated with severe empyema and mediastinal abscess caused by reduction of a recurrent lung metastatic tumor originating from adenocarcinoma of the esophagogastric junction after primary operation].

    Science.gov (United States)

    Kimura, Akiharu; Hiramatsu, Kiyoshi; Sakuragawa, Tadayuki; Ito, Takaaki; Otsuji, Hidehiko; Tsuchiya, Tomonori; Hara, Tomohiro; Maeda, Takao; Tanaka, Hiroshi; Machiki, Yuichi; Hosoya, Jun; Kojima, Tsuyoshi; Kato, Kenji

    2010-02-01

    The patient was a 57-year-old man who presented with cancer of the esophagogastric junction. He underwent total gastrectomy, lower esophagectomy, distal pancreatectomy and splenectomy with para-aortic lymphnode dissection by the transthoracoabdominal approach. He was given a daily dose of 100 mg of S-1 as adjuvant chemotherapy. About one year after the operation, lung metastasis was recognized by enhanced CT examination. He began weekly paclitaxel as second-line chemotherapy. Paclitaxel was infused once a week. About two weeks after the first infusion therapy, he was admitted to our hospital with fever and dyspnea. A chest enhanced CT revealed remarkable empyema and mediastinal abscess. Chest drainage and mediastinal drainage were performed.After one month of drainage, the empyema and mediastinal abscess had improved. The metastastic tumor of the lung disappeared at the time of discharge. CR has been maintained for more than a year without chemotherapy.This case suggests that remarkable reduction of the tumor induced by chemotherapy may have caused the empyema and mediastinal abscess.

  6. The influence of the day of the week of hospital admission on the prognosis of stroke patients.

    Science.gov (United States)

    Barros, Juliana B; Goulart, Alessandra Carvalho; Alencar, Airlane P; Lotufo, Paulo A; Bensenor, Isabela M

    2013-04-01

    This study aimed to evaluate the weekday and weekend distribution of stroke case hospital admissions and their respective prognosis based on a sample from the Estudo de Mortalidade e Morbidade do Acidente Vascular Cerebral (EMMA), a cohort of stroke patients admitted to a community hospital in the city of São Paulo, Brazil. We ascertained all consecutive cases of first-time strokes between April 2006 and December 2008 and performed a subsequent one-year follow-up. No association was found between frequency of hospital admissions due to ischemic and hemorrhagic strokes and the specific day of the week on which the admission occurred. However, ten-day and twelve-month case-fatality was higher in hemorrhagic stroke patients admitted at the weekend. We also found that intracerebral hemorrhage patients admitted on weekends had a worse survival rate (50%) compared with those admitted during weekdays (25.6%, P log-rank = 0.03). We found a multivariate hazard ratio of 2.49 (95%CI: 1.10-5.81, P trend = 0.03) for risk of death at the weekend compared to weekdays for intracerebral hemorrhage cases. No difference in survival was observed with respect to the overall sample of stroke or ischemic stroke patients.

  7. Effects of Panax ginseng extract in patients with fibromyalgia: a 12-week, randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Alessandra S. Braz

    2013-03-01

    Full Text Available The purpose of the study was to evaluate the efficacy of an extract of Panax ginseng in patients with fibromyalgia. A randomized, double-blind, controlled clinical trial was carried out over 12 weeks to compare the effects of P. ginseng (100 mg/d with amitriptyline (25 mg/d and placebo in 38 patients with fibromyalgia: 13 in Group I (amitriptyline, 13 in Group II (placebo, and 12 in Group III (P. ginseng. Ratings on the Visual Analogue Scale (VAS revealed a reduction in pain in the P. ginseng group (p < .0001, an improvement in fatigue (p < .0001 and an improvement in sleep (p < .001, with respect to baseline characteristics, but there were no differences between the three groups. With respect to anxiety, improvements occurred in the P. ginseng group compared to baseline (p < .0001; however, amitriptyline treatment resulted in significantly greater improvements (p < .05. P. ginseng reduced the number of tender points and improved patients' quality of life (using the Fibromyalgia Impact Questionnaire - FIQ; however, there were no differences between groups. The beneficial effects experienced by patients for all parameters suggest a need for further studies to be performed on the tolerability and efficacy of this phytotherapic as a complementary therapy for fibromyalgia.

  8. Phase II study of tailored S-1 monotherapy with a 1-week interval after a 2-week dosing period in elderly patients with advanced non-small cell lung cancer.

    Science.gov (United States)

    Goto, Hisatsugu; Okano, Yoshio; Machida, Hisanori; Hatakeyama, Nobuo; Ogushi, Fumitaka; Haku, Takashi; Kanematsu, Takanori; Urata, Tomoyuki; Kakiuchi, Soji; Hanibuchi, Masaki; Sone, Saburo; Nishioka, Yasuhiko

    2018-01-01

    S-1 is an oral fluoropyrimidine that is active in the treatment of non-small cell lung cancer (NSCLC); however, an optimal treatment schedule and appropriate dose adjustments of S-1 in elderly patients have not yet been established. We conducted a phase II trial to evaluate the efficacy and safety of a 2-week S-1 monotherapy treatment followed by a 1-week interval as a first-line treatment of elderly NSCLC patients, by adjusting the dose based on the individual creatinine clearance (Ccr) and body surface area (BSA). The primary endpoint was the disease control rate. Forty patients were enrolled. The disease control and response rates were 89.5% (95% confidence interval [CI] = 79.8-99.2) and 7.9% (95% CI = 0.0-16.4), respectively. The median progression-free survival and overall survival times were 4.4 months (95% CI = 4.2-8.5) and 17.0 months (95% CI = 11.2-18.7), respectively. Neutropenia, anorexia, hyponatremia, hypokalemia, and pneumonia of grade ≥ 3 occurred in 5.0%, 7.5%, 5.0%, 2.5%, and 2.5% of patients, respectively. Among the patient-reported outcomes, most of the individual factors in the patients' quality of life, including upper intestine-related symptoms improved with the treatment, except for dyspnea, which slightly albeit continuously worsened throughout the study. In elderly patients with previously untreated advanced NSCLC, a 2-week S-1 monotherapy treatment, tailored to both the Ccr and BSA, with a 1-week interval was well tolerated and demonstrated promising efficacy. This study was registered at the University Hospital Medical Information Network (UMIN) Center (ID: UMIN000002035), Japan. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  9. Phase II study of weekly 4'-epidoxorubicin in patients with metastatic adenocarcinoma of the cervix: an EORTC Gynaecological Cancer Cooperative Group study

    NARCIS (Netherlands)

    van der Burg, M. E.; Bolis, G.; Bakker, P. J.; Curran, D.; Sahmoud, T.; Vermorken, J. B.

    1997-01-01

    In this study 22 patients with metastatic adenocarcinoma of the cervix were treated with a weekly bolus injection of 4'-epidoxorubicin at a dose of 12 mg/m2. Seventeen patients had received prior radiotherapy, all patients were chemo-naive. Toxicity was generally absent or very mild. One patient had

  10. Time Course of Improvement of Metabolic Parameters after a 12 Week Physical Exercise Programme in Patients with Type 2 Diabetes: The Influence of Gender in a Nigerian Population

    Directory of Open Access Journals (Sweden)

    A. F. Adeniyi

    2013-01-01

    Full Text Available Gender is a major determinant of the outcomes of many health interventions. This study documents the order of significant improvements in metabolic parameters of patients with type 2 diabetes mellitus (T2DM having metabolic syndrome within 12 weeks of physical exercise programmes. Twenty-nine patients, mean age 49.6 ± 3.7 years, presenting with high fasting plasma glucose, high triglycerides, hypertension, and high waist circumference undertook a thrice weekly aerobic and endurance exercise programme in addition to their drugs and diet. Variables were assessed at baseline and end of every two weeks for twelve weeks. Compared with baseline, significant improvement (P<0.05 in the metabolic parameters occurred in this order for the male participants: fasting glucose (2nd week, triglycerides and waist circumference (4th week, and systolic blood pressure (12th week. For the female participants, it was fasting glucose (4th week, triglycerides (6th week, and waist circumference (10th week. Regardless of the gender, fasting glucose was the first to improve significantly, followed by triglycerides. Hypertension did not improve significantly at all in the female participants as they may require more than twelve weeks of therapeutic exercise for any significant improvement in hypertension.

  11. Evaluation of Prevalence of Oral Candidiasis in Patients Using Complete Denture Wears

    Directory of Open Access Journals (Sweden)

    P Tavakkol

    2001-06-01

    Full Text Available Denture stomatotos os a common problem of the denture wears, and its etiology is not clear from the literatures. Some studies show that the aetiology is candida albicans, while other reports point out the other agents including candida albicans. The present study was designed to evaluate the prevalence of oral candidiasis in patients using complete denture with different datas. 50 subjects all wearing complete denture participated in this study. The palatal mucosa was swabbed and swabs were cultured in Sabourauds medium containing 0.005% chloramphenicol then cultures were tested with common mycological lab tests. In 80% of patients oral candidiasis have been diagnosed. In the investigation a direct relation between the oral candidiasis and removal of denture at night, denture cleanliness, presence of any suction and symptoms of denture stomatitis was shown. No relation between the oral candidiasis and sex, smoking habit, succeptible disease, angular cheilitis; the recent condition of denture and the retention of denture were found. The findings of our investigation indicates that candida albicans is the causative agent of denture stomatitis while other factors such as denture cleanliness, removal of denture at night and presence of any suction may be considered as well.

  12. Impact of Complete Parenteral Nutrition on Metabolic Processes in Cancer Patients in the Early Postoperative Period

    Directory of Open Access Journals (Sweden)

    O. A. Obukhova

    2011-01-01

    Full Text Available Objective: to estimate blood glucose levels during complete parenteral nutrition (CPN, by using the three-in-one system with a high glucose level. Subjects and methods. Thirty adult patients without diabetes mellitus (including 18 men were examined. Twelve and 18 patients were operated on for colonic and gastric cancers, respectively. CPN (Oliclinomel No. 7 — 1000, 1500 ml; glucose, 240 g in 1500 ml, Baxter, Belgium was carried out at the Surgery Department in the early postoperative period (3-5 postoperative days with stable hemodynamics and no organ dysfunction (acute respiratory, renal, hepatic failure. The preparation was administered at a rate of about 83 ml/h over 18 hours. Insulin was not used. Serum glucose concentrations were measured before the study and then for 24 hours at an interval of 6 hours. Results. Glucose concentrations were not found to exceed the allowable values in the majority of patients during CPN at the given rate. In 5 (16.7% patients, short-term glucose increases up to 13.3 mmol/l were corrected, by decreasing the infusion rate. There was no hypoglycemia or other complications during CPN. Conclusion. Our findings suggest that three-in-one parenteral feeding is safe and causes no metabolic disturbances if simple principles are followed, the basic ones of which are to observe the intake of an adequate total dose and the rate of administration of nutrients. Key words: parenteral feeding, hyperglycemia, metabolic disturbances.

  13. Test-retest reliability and four-week changes in cardiopulmonary fitness in stroke patients: evaluation using a robotics-assisted tilt table.

    Science.gov (United States)

    Saengsuwan, Jittima; Berger, Lucia; Schuster-Amft, Corina; Nef, Tobias; Hunt, Kenneth J

    2016-09-06

    Exercise testing devices for evaluating cardiopulmonary fitness in patients with severe disability after stroke are lacking, but we have adapted a robotics-assisted tilt table (RATT) for cardiopulmonary exercise testing (CPET). Using the RATT in a sample of patients after stroke, this study aimed to investigate test-retest reliability and repeatability of CPET and to prospectively investigate changes in cardiopulmonary outcomes over a period of four weeks. Stroke patients with all degrees of disability underwent 3 separate CPET sessions: 2 tests at baseline (TB1 and TB2) and 1 test at follow up (TF). TB1 and TB2 were at least 24 h apart. TB2 and TF were 4 weeks apart. A RATT equipped with force sensors in the thigh cuffs, a work rate estimation algorithm and a real-time visual feedback system was used to guide the patients' exercise work rate during CPET. Test-retest reliability and repeatability of CPET variables were analysed using paired t-tests, the intraclass correlation coefficient (ICC), the coefficient of variation (CoV), and Bland and Altman limits of agreement. Changes in cardiopulmonary fitness during four weeks were analysed using paired t-tests. Seventeen sub-acute and chronic stroke patients (age 62.7 ± 10.4 years [mean ± SD]; 8 females) completed the test sessions. The median time post stroke was 350 days. There were 4 severely disabled, 1 moderately disabled and 12 mildly disabled patients. For test-retest, there were no statistically significant differences between TB1 and TB2 for most CPET variables. Peak oxygen uptake, peak heart rate, peak work rate and oxygen uptake at the ventilatory anaerobic threshold (VAT) and respiratory compensation point (RCP) showed good to excellent test-retest reliability (ICC 0.65-0.94). For all CPET variables, CoV was 4.1-14.5 %. The mean difference was close to zero in most of the CPET variables. There were no significant changes in most cardiopulmonary performance parameters during the 4-week period

  14. Maraviroc Intensification of cART in Patients with Suboptimal Immunological Recovery: A 48-Week, Placebo-Controlled Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Steven F L van Lelyveld

    Full Text Available The immunomodulatory effects of the CCR5-antagonist maraviroc might be beneficial in patients with a suboptimal immunological response, but results of different cART (combination antiretroviral therapy intensification studies are conflicting. Therefore, we performed a 48-week placebo-controlled trial to determine the effect of maraviroc intensification on CD4+ T-cell counts and immune activation in these patients.Double-blind, placebo-controlled, randomized trial.Major inclusion criteria were 1. CD4+ T-cell count <350 cells/μL while at least two years on cART or CD4+ T-cell count <200 cells/μL while at least one year on cART, and 2. viral suppression for at least the previous 6 months. HIV-infected patients were randomized to add maraviroc (41 patients or placebo (44 patients to their cART regimen for 48 weeks. Changes in CD4+ T-cell counts (primary endpoint and other immunological parameters were modeled using linear mixed effects models.No significant differences for the modelled increase in CD4+ T-cell count (placebo 15.3 CD4+ T cells/μL (95% confidence interval (CI [1.0, 29.5] versus maraviroc arm 22.9 CD4+ T cells/μL (95% CI [7.4, 38.5] p = 0.51 or alterations in the expression of markers for T-cell activation, proliferation and microbial translocation were found between the arms. However, maraviroc intensification did increase the percentage of CCR5 expressing CD4+ and CD8+ T-cells, and the plasma levels of the CCR5 ligand MIP-1β. In contrast, the percentage of ex-vivo apoptotic CD8+ and CD4+ T-cells decreased in the maraviroc arm.Maraviroc intensification of cART did not increase CD4+ T-cell restoration or decrease immune activation as compared to placebo. However, ex-vivo T-cell apoptosis was decreased in the maraviroc arm.ClinicalTrials.gov NCT00875368.

  15. Once-weekly versus every-other-day stereotactic body radiotherapy in patients with prostate cancer (PATRIOT): A phase 2 randomized trial.

    Science.gov (United States)

    Quon, Harvey C; Ong, Aldrich; Cheung, Patrick; Chu, William; Chung, Hans T; Vesprini, Danny; Chowdhury, Amit; Panjwani, Dilip; Pang, Geordi; Korol, Renee; Davidson, Melanie; Ravi, Ananth; McCurdy, Boyd; Zhang, Liying; Mamedov, Alexandre; Deabreu, Andrea; Loblaw, Andrew

    2018-05-01

    Prostate stereotactic body radiotherapy (SBRT) regimens differ in time, dose, and fractionation. We completed a multicentre, randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL). Men with low and intermediate-risk prostate cancer were randomly assigned to 40 Gy in 5 fractions delivered once per week (QW) vs. every other day (EOD). QOL was assessed using the Expanded Prostate Cancer Index Composite. The primary endpoint was the proportion with a minimum clinically important change (MCIC) in bowel QOL during the acute (≤12 week) period, and analysis was by intention-to-treat. ClinicalTrials.gov NCT01423474. 152 men from 3 centres were randomized with median follow-up of 47 months. Patients treated QW had superior acute bowel QOL with 47/69 (68%) reporting a MCIC compared to 63/70 (90%) treated EOD (p = 0.002). Fewer patients treated QW reported moderate-severe problems with bowel QOL during the acute period compared with EOD (14/70 [20%] vs. 40/70 [57%], p < 0.001). Acute urinary QOL was also better in the QW arm, with 52/67 (78%) vs 65/69 (94%) experiencing a MCIC (p = 0.006). There were no significant differences in late urinary or bowel QOL at 2 years or last follow-up. Prostate SBRT delivered QW improved acute bowel and urinary QOL compared to EOD. Patients should be counselled regarding the potential for reduced short-term toxicity and improved QOL with QW prostate SBRT. Copyright © 2018 Elsevier B.V. All rights reserved.

  16. A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite-allergic patients.

    Science.gov (United States)

    Hüser, C; Dieterich, P; Singh, J; Shah-Hosseini, K; Allekotte, S; Lehmacher, W; Compalati, E; Mösges, R

    2017-01-01

    In sublingual immunotherapy, optimal doses are a key factor for therapeutic outcomes. The aim of this study with tablets containing carbamylated monomeric house dust mite allergoids was to determine the most effective and safe dose. In this double-blind, placebo-controlled dose-finding study, 131 patients with house dust mite-induced allergic rhinoconjunctivitis were randomized to 12-week treatments with 300 UA/day, 1000 UA/day, 2000 UA/day, 3000 UA/day or placebo. Conjunctival provocation tests (CPT) were performed before, during and after treatment. The change in mean allergic severity (primary endpoint), calculated from the severity of the CPT reaction, and the proportion of patients with an improved CPT threshold (secondary endpoint) determined the treatment effect. The mean allergic severity decreased in all groups, including the placebo group. It was lower in all active treatment groups (300 UA/day: 0.14, 1000 UA/day: 0.15, 2000 UA/day: 0.10, 3000 UA/day: 0.15) than in the placebo group (0.30). However, this difference was not statistically significant (P allergoid sublingual tablets is well tolerated and reduces the CPT reaction in house dust mite-allergic patients. © 2016 The Authors. Allergy Published by John Wiley & Sons Ltd.

  17. Floor Effect of PROMIS Depression CAT Associated With Hasty Completion in Orthopaedic Surgery Patients.

    Science.gov (United States)

    Guattery, Jason M; Dardas, Agnes Z; Kelly, Michael; Chamberlain, Aaron; McAndrew, Christopher; Calfee, Ryan P

    2018-04-01

    Function and Depression CATs and was compared between assessments within each group as well as between the two groups. Bivariate statistics compared the demographic data between the two groups. Physical Function CAT scores in musculoskeletal patients were normally distributed like the distribution calibration population; however, the score distribution of the Depression CAT in musculoskeletal patients was nonnormal with a spike in the floor score. After excluding the floor spike, the distribution of the Depression CAT scores was not different from the population control group. Patients who scored the floor score on the Depression CAT took slightly less time per question for Physical Function CAT when compared with other musculoskeletal patients (floor patients: 11 ± 9 seconds; normally distributed patients: 12 ± 10 seconds; mean difference: 1 second [0.8-1.1]; p CAT (Floor Group: 4 ± 3 seconds; Standard Group: 7 ± 7 seconds; mean difference: 3 [2.9-3.2]; p CAT were younger than other patients (Floor Group: 50 ± 18 SD; Standard Group: 55 ± 16 SD; mean difference: 4.5 [4.2-4.7]; p CAT as part of routine practice, the Physical Function item bank had a normal performance, but there is a group of patients who hastily complete Depression questions producing a strong floor effect and calling into question the validity of those floor scores that indicate minimal depression. Level II, diagnostic study.

  18. Phase II trial of weekly 24-hour infusion of gemcitabine in patients with advanced gallbladder and biliary tract carcinoma

    International Nuclear Information System (INIS)

    Delius, Stefan von; Lersch, Christian; Schulte-Frohlinde, Ewert; Mayr, Martina; Schmid, Roland M; Eckel, Florian

    2005-01-01

    Patients with advanced gallbladder and biliary tract carcinoma face a dismal prognosis, as no effective palliative chemotherapy exists. The antitumor effect of gemcitabine is schedule-dependent rather than dose-dependent. We evaluated the activity of a prolonged infusion of gemcitabine in advanced gallbladder and biliary tract carcinomas. Nineteen consecutive eligible patients were enrolled. All patients were required to have histologically confirmed diagnosis and measurable disease. Gemcitabine was infused over 24 hours at a dose of 100 mg/m 2 on days 1, 8, and 15. Treatment was repeated every 28 days until progression of disease or limiting toxicity. Tumor response was evaluated every second course by computed tomography (CT) scans. Eighteen patients were evaluable for response. A total of 89 cycles of therapy were administered. One partial response was observed (6%; 95% confidence interval (CI): 0–27%) and ten additional patients had stable disease for at least two months (disease control rate 61%; 95% CI: 36–83%). The therapy was well tolerated, with moderate myelosuppression as the main toxicity. The median time to tumor progression and median overall survival was 3.6 months (95% CI 2.6–4.6 months) and 7.5 months (95% CI 6.5–8.5 months), respectively. Weekly 24-hour gemcitabine at a dose of 100 mg/m 2 is well tolerated. There was a relatively high rate of disease control for a median duration of 5.3 months (range 2.8–18.8 months). However, the objective response rate of this regimen in gallbladder and biliary tract carcinomas was limited

  19. Presence of pain on three or more days of the week is associated with worse patient reported outcomes in adults with sickle cell disease

    Directory of Open Access Journals (Sweden)

    Bakshi N

    2018-02-01

    Full Text Available Nitya Bakshi,1,2 Diana Ross,1 Lakshmanan Krishnamurti1,2 1Division of Pediatric Hematology-Oncology-BMT, Department of Pediatrics, Emory University, Atlanta, GA, USA; 2Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta, Atlanta, GA, USA Abstract: While acute episodic pain is the hallmark of sickle cell disease (SCD, transition to chronic pain is a major cause of morbidity and impaired quality of life. One of the core diagnostic criteria used by Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy (AAPT to define chronic SCD pain is the presence of pain on a “majority of days” in the past 6 months in one or more locations. The frequency characteristic of “majority of days” is adapted from the criteria of 15 days or more per month, used to define chronic migraine, but there are inadequate data to support this cutoff in SCD. Using an existing dataset of adults with SCD who completed patient-reported outcomes of pain interference, physical functioning, anxiety, depression, and fatigue using the National Institutes of Health (NIH patient-reported outcomes measures information system (PROMIS short-form instruments, we examined the association of the presence of pain on 3 or more days per week with patient-reported outcomes of functioning. In unadjusted analyses, presence of pain on 3 or more days a week was associated with higher median PROMIS scores of pain interference, anxiety, and depression. Median PROMIS scores of fatigue and physical function were worse in women compared with men in unadjusted analyses. We did not find any difference in median PROMIS pain scores between adults aged ≤35 years compared with those aged ≥35 years. In linear regression models, after adjustment for age and sex, the presence of pain on 3 or more days a week was found to be associated with worse pain interference and anxiety. These data support

  20. Sertraline and periodic limb movements during sleep: an 8-week open-label study in depressed patients with insomnia.

    Science.gov (United States)

    Zhang, Bin; Hao, Yanli; Jia, Fujun; Li, Xueli; Ren, Yanzhen; Zhou, Ping; Liu, Wuhan; Wing, Yun Kwok

    2013-12-01

    Previous studies have reported that selective serotonin reuptake inhibitors (SSRIs) might induce or exacerbate periodic limb movements during sleep (PLMS). However, most of these studies were retrospective and cross-sectional studies with small sample sizes on a selective SSRI, fluoxetine. Because different SSRIs have different pharmacologic profiles, it was not certain if other SSRIs also might lead to PLMS. Data were taken from an open-label 8-week trial of sertraline in depressive patients with insomnia (n=31). Depressed patients were administered sertraline 50mg at 8:00am on the first day, and the dosage was subsequently titrated up to a maximum of 200mg daily during the 8-week trial. All participants were tested by repeated polysomnography (PSG) (baseline, first day, 14th day, 28th day, and 56th day). Periodic leg movements (PLM) were visually counted and the PLM index (PLMI) was calculated. PLMS was defined as PLMI ⩾5, and significant PLMS was defined as PLMI ⩾15. Compared with baseline (PLMI, 3.6±1.5), all PLMI indices increased on the immediate administration of sertraline on the first day (PLMI, 5.1±3.9). From the 14th day onward, PLMI became stable and significantly higher than baseline and the first day (8.7±3.1 on the 14th day, 8.3±3.7 on the 28th day, and 8.5±3.6 on the 56th day; F[11.81]; P=.003). The clinical responses and PSG characteristics continuously improved during the 8-week trial. The PLMS group (PLMI ⩾5) had a higher arousal index (AI) than the non-PLMS group on the 14th day (9.4±5.5 vs 5.2±3.7; t test, 4.22; P=.03) and the 56th day (8.1±5.5 vs 4.3±3.7; z score, 3.11; P=.04); albeit, there was no significant clinical disturbances in the PLMS group. PLMS were increased during sertraline treatment, but only a few of the PLMS reached the significant level. This effect of sertraline on PLMS might be dosage dependent. Although the sertraline-induced PLMS did not seem to cause significant clinical disturbance, the PLMS group (PLMI

  1. Early decrements in bone density after completion of neoadjuvant chemotherapy in pediatric bone sarcoma patients

    Directory of Open Access Journals (Sweden)

    Hardes Jendrik

    2010-12-01

    Full Text Available Abstract Background Bone mineral density (BMD accrual during childhood and adolescence is important for attaining peak bone mass. BMD decrements have been reported in survivors of childhood bone sarcomas. However, little is known about the onset and development of bone loss during cancer treatment. The objective of this cross-sectional study was to evaluate BMD in newly diagnosed Ewing's and osteosarcoma patients by means of dual-energy x-ray absorptiometry (DXA after completion of neoadjuvant chemotherapy. Methods DXA measurements of the lumbar spine (L2-4, both femora and calcanei were performed perioperatively in 46 children and adolescents (mean age: 14.3 years, range: 8.6-21.5 years. Mean Z-scores, areal BMD (g/cm2, calculated volumetric BMD (g/cm3 and bone mineral content (BMC, g were determined. Results Lumbar spine mean Z-score was -0.14 (95% CI: -0.46 to 0.18, areal BMD was 1.016 g/cm2 (95% CI: 0.950 to 1.082 and volumetric BMD was 0.330 g/cm3 (95% CI: 0.314 to 0.347 which is comparable to healthy peers. For patients with a lower extremity tumor (n = 36, the difference between the affected and non-affected femoral neck was 12.1% (95% CI: -16.3 to -7.9 in areal BMD. The reduction of BMD was more pronounced in the calcaneus with a difference between the affected and contralateral side of 21.7% (95% CI: -29.3 to -14.0 for areal BMD. Furthermore, significant correlations for femoral and calcaneal DXA measurements were found with Spearman-rho coefficients ranging from ρ = 0.55 to ρ = 0.80. Conclusions The tumor disease located in the lower extremity in combination with offloading recommendations induced diminished BMD values, indicating local osteopenia conditions. However, the results revealed no significant decrements of lumbar spine BMD in pediatric sarcoma patients after completion of neoadjuvant chemotherapy. Nevertheless, it has to be taken into account that bone tumor patients may experience BMD decrements or secondary osteoporosis

  2. The utility and cost-effectiveness of serial complete blood count monitoring in patients receiving radiation therapy for localized prostate cancer

    International Nuclear Information System (INIS)

    Blank, Kenneth; Cascardi, Michelle; Kao, Gary D.

    1997-01-01

    Purpose/Objective: It has been a standard practice in our department to monitor weekly complete blood counts (CBC) in patients receiving pelvic radiation therapy for prostate cancer. The utility and cost-effectiveness of this practice has not been analyzed. Material and Methods: We analyzed 1572 separate CBCs performed on 110 consecutive outpatients treated at the Veterans Administration Medical Center, Philadelphia, PA from June 1994 to June 1996 for localized prostate cancer. 92 of these patients fulfilled the study inclusion criteria of blood counts on at least four different weeks of treatment, a baseline hemoglobin (pretreatment or week one of radiation therapy), and at least one CBC after week four. Complete data was subjected to chi-square statistical analysis of factors including age, field size, concomitant hormonal therapy and the presence of hypertension or diabetes. Results: The mean hemoglobin level at the beginning of treatment of was 13.2 grams/dl (gms) and mean change in hemoglobin from baseline to the last week of treatment was - 0.53 gms (range +2.0 to -3.5 gm). No patients required blood transfusion or erythropoeitin treatment, and only five patients experienced declines of >2.0 gms (-2.1, -2.3, -2.5, -2.9 and -3.5). Two of these patients sustained the hemoglobin declines concomitantly with congestive heart failure requiring intensive care unit admission (suggesting fluid overload). The hemoglobin level in the remaining patients has returned to normal without treatment by one month after the end of radiation. No significant differences were found between the group of patients that dropped more than 1.0 gm (n=34) and the group that did not (n = 58) in field size (p0.08), presence of diabetes (p= 0.48) or hypertension (p= 0.43), concurrent or prior hormone therapy (p= 0.37), or age (p=0.83). No consistent trends in white blood cell or platelet counts could be detected during radiation and no patients had white blood cells counts fall below 2000/mm

  3. Life experiences of patients who have completed tuberculosis treatment: a qualitative investigation in southeast Brazil

    Science.gov (United States)

    2013-01-01

    Background Despite being curable, tuberculosis is still a stigmatized disease. Not only is TB patients’ suffering due to its clinical manifestations, but also because of society’s prejudice, embarrassing situations, and even self-discrimination. This study aims to investigate psychosocial experiences of patients who have completed tuberculosis treatment in São Carlos a municipality in the interior of São Paulo State, Brazil. Methods This study, of a clinical-qualitative nature, sought to understand the meanings provided by the participants themselves. Fifteen individuals, who had successfully completed tuberculosis treatment, participated in this research. The sample size was established using the information saturation criterion. Data were collected by means of interviews with in-depth open-ended questions. Data were treated by categorizing and analyzing content according to themes. Results Regardless of all progress, this study found that TB still causes patients to suffer from fear of transmission, social prejudice, and death. Despite the fact that the emotional support provided by families and healthcare professionals is considered essential to treatment adherence and completion, participants in this study reveal that friends and colleagues have distanced themselves from them for fear of contagion and/or prejudice. Ignorance about the disease and its transmission modes can be found in the interviewees’ statements, which seems to indicate that they have become vectors of transmission of stigma themselves. Patients’ medical leave from work during treatment may be due to both their health conditions and their attempt to avoid social/emotional embarrassment. There are accounts that TB has caused psychosocial damage to patients’ lives and that they feel more fatigue and lassitude and have begun to pay more attention to their own health. Conclusions Healthcare workers should be aware of the ways TB treatment affect patients’ psychosocial life and

  4. Speech outcome in unilateral complete cleft lip and palate patients: a descriptive study.

    Science.gov (United States)

    Rullo, R; Di Maggio, D; Addabbo, F; Rullo, F; Festa, V M; Perillo, L

    2014-09-01

    In this study, resonance and articulation disorders were examined in a group of patients surgically treated for cleft lip and palate, considering family social background, and children's ability of self monitoring their speech output while speaking. Fifty children (32 males and 18 females) mean age 6.5 ± 1.6 years, affected by non-syndromic complete unilateral cleft of the lip and palate underwent the same surgical protocol. The speech level was evaluated using the Accordi's speech assessment protocol that focuses on intelligibility, nasality, nasal air escape, pharyngeal friction, and glottal stop. Pearson product-moment correlation analysis was used to detect significant associations between analysed parameters. A total of 16% (8 children) of the sample had severe to moderate degree of nasality and nasal air escape, presence of pharyngeal friction and glottal stop, which obviously compromise speech intelligibility. Ten children (10%) showed a barely acceptable phonological outcome: nasality and nasal air escape were mild to moderate, but the intelligibility remained poor. Thirty-two children (64%) had normal speech. Statistical analysis revealed a significant correlation between the severity of nasal resonance and nasal air escape (p ≤ 0.05). No statistical significant correlation was found between the final intelligibility and the patient social background, neither between the final intelligibility nor the age of the patients. The differences in speech outcome could be explained with a specific, subjective, and inborn ability, different for each child, in self-monitoring their speech output.

  5. Supra-complete surgery via dual intraoperative visualization approach (DiVA) prolongs patient survival in glioblastoma.

    Science.gov (United States)

    Eyüpoglu, Ilker Y; Hore, Nirjhar; Merkel, Andreas; Buslei, Rolf; Buchfelder, Michael; Savaskan, Nicolai

    2016-05-03

    Safe and complete resection represents the first step in the treatment of glioblastomas and is mandatory in increasing the effectiveness of adjuvant therapy to prolong overall survival. With gross total resection currently limited in extent to MRI contrast enhancing areas, the extent to which supra-complete resection beyond obvious contrast enhancement could have impact on overall survival remains unclear. DiVA (dual intraoperative visualization approach) redefines gross total resection as currently accepted by enabling for the first time supra-complete surgery without compromising patient safety. This approach exploits the advantages of two already accepted surgical techniques combining intraoperative MRI with integrated functional neuronavigation and 5-ALA by integrating them into a single surgical approach. We investigated whether this technique has impact on overall outcome in GBM patients. 105 patients with GBM were included. We achieved complete resection with intraoperative MRI alone according to current best-practice in glioma surgery in 75 patients. 30 patients received surgery with supra-complete resection. The control arm showed a median life expectancy of 14 months, reflecting current standards-of-care and outcome. In contrast, patients receiving supra-complete surgery displayed significant increase in median survival time to 18.5 months with overall survival time correlating directly with extent of supra-complete resection. This extension of overall survival did not come at the cost of neurological deterioration. We show for the first time that supra-complete glioma surgery leads to significant prolongation of overall survival time in GBM patients.

  6. A Daily Glass of Red Wine and Lifestyle Changes Do Not Affect Arterial Blood Pressure and Heart Rate in Patients with Carotid Arteriosclerosis after 4 and 20 Weeks

    Directory of Open Access Journals (Sweden)

    Dirk W. Droste

    2013-10-01

    Full Text Available Background: Regular consumption of small amounts of red wine improves blood lipids. However, there is concern whether this beneficial effect might be counterbalanced by an increase in blood pressure (BP and heart rate (HR, which are risk factors for cerebro-cardiovascular disease. In particular, we studied whether regular consumption of red wine with and without lifestyle changes (LC; healthy diet and physical activity advice results in an increase in BP and HR. Methods: A prospective, unblinded randomized trial was performed in 108 patients (67% men with carotid atherosclerosis documented by ultrasound, a mean BP of 122/79 mm Hg and a mean HR of 71 bpm at inclusion in the study. Sixty-eight percent were known and treated hypertensives. The mean 24-hour BP at baseline was 122/79 mm Hg. Half of the study participants, the control group, was seen by a nurse at baseline, after 4 and after 20 weeks, and was instructed not to change their eating and physical activity habits. In the other half, a dietician performed five sessions of 30 min each (at baseline, after 1 week and after 2, 3 and 4 weeks giving advice on healthy eating based on a Mediterranean diet and physical exercise. The recommendations given were the following: 5 portions of fruit/vegetables per day, a diet low in absolute fat, a preference of vegetable oil (olive or rapeseed oil, whole-grain products, poultry, low-fat dairy products, 1 fat and 1 lean fish meal per week, reduced consumption of red meat, and avoidance of pork, ready-made meals, sugar and excessive salt intake. In addition, regular consumption of 1 bar of dark chocolate (25 g, >70% of cacao, 1-2 tomatoes, and 3-5 walnuts as well as at least 30 min of moderate daily physical activity were recommended. Within these two groups, half of the patients were randomized either to avoid alcohol completely or to drink 100 ml (women or 200 ml of red wine (men daily. Results: Neither LC nor red wine had an effect on the mean systolic

  7. A phase I trial of PR-104, a pre-prodrug of the bioreductive prodrug PR-104A, given weekly to solid tumour patients

    International Nuclear Information System (INIS)

    McKeage, Mark J; Gu, Yongchuan; Wilson, William R; Hill, Andrew; Amies, Karen; Melink, Teresa J; Jameson, Michael B

    2011-01-01

    The phosphate ester PR-104 is rapidly converted in vivo to the alcohol PR-104A, a nitrogen mustard prodrug that is metabolised to hydroxylamine (PR-104H) and amine (PR-104M) DNA crosslinking agents by one-electron reductases in hypoxic cells and by aldo-keto reductase 1C3 independently of oxygen. In a previous phase I study using a q 3 week schedule of PR-104, the maximum tolerated dose (MTD) was 1100 mg/m 2 and fatigue, neutropenic fever and infection were dose-limiting. The primary objective of the current study was to determine the dose-limiting toxicity (DLT) and MTD of weekly PR-104. Patients with advanced solid tumours received PR-104 as a 1-hour intravenous infusion on days 1, 8 and 15 every 28 days with assessment of pharmacokinetics on cycle 1 day 1. Twenty-six patients (pts) were enrolled (16 male/10 female; median age 58 yrs, range 30 to 70 yrs) who had received a median of two prior chemotherapy regimens (range, 0 to 3) for melanoma (8 pts), colorectal or anal cancer (3 pts), NSCLC (3 pts), sarcoma (3 pts), glioblastoma (2 pts), salivary gland tumours (2 pts) or other solid tumours (5 pts). PR-104 was administered at 135 mg/m 2 (3 pts), 270 mg/m 2 (6 pts), 540 mg/m 2 (6 pts), 675 mg/m 2 (7 pts) and 900 mg/m 2 (4 pts) for a median of two treatment cycles (range, 1 to 7 cycles) and five infusions (range, 1 to 18) per patient. Dose-limiting toxicities (DLTs) during cycle one included grade four thrombocytopenia at 540 mg/m 2 (1 of 6 pts) and grade four thrombocytopenia and neutropenia at 900 mg/m 2 (2 of 4 pts). At an intermediate dose of 675 mg/m 2 , there were no DLTs among a total of seven patients given 12 treatment cycles but all experienced moderate to severe (grade 2 to 4) haematological toxicity. Thrombocytopenia was delayed in its onset and nadir, and its recovery was protracted and incomplete in many patients. There were no complete or partial tumour responses. PR-104-induced thrombocytopenia and neutropenia correlated with plasma AUC of PR-104

  8. A randomized phase II study of carboplatin with weekly or every-3-week nanoparticle albumin-bound paclitaxel (abraxane) in patients with extensive-stage small cell lung cancer.

    Science.gov (United States)

    Grilley-Olson, Juneko E; Keedy, Vicki L; Sandler, Alan; Moore, Dominic T; Socinski, Mark A; Stinchcombe, Thomas E

    2015-02-01

    Platinum plus etoposide is the standard therapy for extensive-stage small cell lung cancer (ES-SCLC) and is associated with significant myelosuppression. We hypothesized that the combination of carboplatin and nanoparticle albumin-bound paclitaxel (nab-paclitaxel) would be better tolerated. We investigated carboplatin with nab-paclitaxel on every-3-week and weekly schedules. This noncomparative randomized phase II trial used a two-stage design. The primary objective was objective response rate, and secondary objectives were progression-free survival, overall survival, and toxicity. Patients with ES-SCLC and an Eastern Cooperative Oncology Group performance status ≤2 and no prior chemotherapy were randomized in a 1:1 ratio to arm A (carboplatin area under the curve [AUC] of 6 on day 1 and nab-paclitaxel of 300 mg/m(2) on day 1 every 3 weeks) or arm B (carboplatin AUC of 6 on day 1 and nab-paclitaxel 100 mg/m(2) on days 1, 8, and 15 every 21 days). Response was assessed after every two cycles. Patients required frequent dose reductions, treatment delays, and omission of the weekly therapy. The trial was closed because of slow accrual. Carboplatin and nab-paclitaxel demonstrated activity in ES-SCLC but required frequent dose adjustments. ©AlphaMed Press; the data published online to support this summary is the property of the authors.

  9. Complete pathological response after neoadjuvant therapy in patients with rectal adenocarcinoma

    Directory of Open Access Journals (Sweden)

    E.A. Sánchez-Pérez

    2017-10-01

    Full Text Available Background: Colorectal cancer is the fourth most common cancer and the second leading cause of death from cancer in the United States. Preoperative neoadjuvant therapy (chemotherapy and radiotherapy is the gold standard in the management of rectal cancer before surgical resection. The literature includes reports of absence of neoplastic cells after neoadjuvant therapy. There are no reports on complete pathological response to this type of therapy in Mexico. Objectives: Determine the percentage of patients with rectal adenocarcinoma with complete pathological response after neoadjuvant therapy. All patients were treated in a colorectal surgery department of a tertiary care hospital. Materials and methods: A total of 64 patients with rectal adenocarcinoma diagnosed by biopsy were treated from January 2010 to December 2015. Demographic data, tumour localisation, pathological report, TNM stage, neoadjuvant therapy, surgical procedure and postoperative pathological report were collected from patient records. Results: Mean patient age was 52.8 years (range of 26–73; 31 were women and 33 men. Twenty-seven patients (27 were stage II and 27 stage III. The preoperative biopsy results were classified as: well differentiated (10; moderately differentiated (48; and poorly differentiated/undifferentiated adenocarcinoma (6. Twenty patients received neoadjuvant therapy (31.2%. In these, 2 tumours were localised in the upper third of the rectum, 6 in the middle third, and 12 in the lower third. Six patients underwent abdominoperineal resection, 10 total mesorectal excision, and four posterior pelvic exenteration. Six patients undergoing neoadjuvant therapy had a complete pathological response. Conclusions: The percentage of patients with a complete pathological response is similar to that in other literature reports. More evidence is needed to define good prognosis factors in patients who might not require surgery after neoadjuvant therapy. Resumen

  10. Complete Heart Block in a Patient Taking Trachyspermum ammi and Zingiber officinale

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    Hesamoddin Hosseinjani

    2018-02-01

    Full Text Available Herbal products are one of the most popular medications in the world. Nevertheless, herbal medications are not always safe and several cases of side effects have been reported. A 34 years old man was referred to Tehran heart center (THC for implantation of permanent pacemaker (PPM. Recently, he had experienced several episodes of presyncope and according to the diagnosis of Complete Heart Block (CHB with accelerated junctional rhythm, a temporary pacemaker (TPM was implanted for him in another medical center. He had rheumatoid arthritis, type 2 diabetes mellitus and fatty liver in his past medical history. In his drug history, the patient took only herbal medications for the treatment of his ailments among them daily use of Trachyspermum ammi and Zingiber officinale (ginger products were the main causes of this adverse effect.

  11. The effect of complex rehabilitation training for 12 weeks on trunk muscle function and spine deformation of patients with SCI.

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    Sung, Dong-Hun; Yoon, Seong-Deok; Park, Gi Duck

    2015-03-01

    [Purpose] It is important for patients with incomplete spinal cord injury (SCI) to strengthen their muscle strength and return to the work force one of the ultimate objectives of rehabilitation. This study reports how a single patient with SCI became stabilized in terms of abdominal muscles and back extension muscles, as well as returning the back to the neutral position from spinal deformation, as result of complex exercises performed for 12 weeks. [Subjects] The degree of damage of the subject was rated as C grade. The subject of this study had unstable posture due to paralysis in the lower extremities of the left side after removal of a malignant tumor by surgical operation, and tilting and torsion in the pelvis increased followed by increase of kyphosis in the thoracolumbar spine. The subject was more than two years since diagnosis of incomplete SCI after surgery. [Methods] Using isokinetic lumbar muscle strength measurement equipment, peak torque/weight, total work and average power in flexion and extension of the lumbar region were measured. A trunk measurement system (Formetric 4D, DIERS, Germany), which is a 3D image processing apparatus with high resolution for vertebrae, was used in order to measure 3D vertebrae and pelvis deformation as well as static balance abilities. As an exercise method, a foam roller was used to conduct fascia relaxation massage for warming-up, and postural kyphosis was changed into postural lordosis by lat pull-down using equipment, performed in 5 sets of 15 times preset at 60% intensity of 1RM 4 set of 10 crunch exercises per set using Togu's were done while sitting at the end of Balance pad, and 4 sets of 15 bridge exercises. [Results] All angular speed tests showed a gradual increase in muscle strength. Flexion and extension showed 10% and 3% improvements, respectively. The spine deformation test showed that isokinetic exercise and lat pull-down exercise for 12 weeks resulted in improved spinal shape. [Conclusion] In this study

  12. Inflammation's Association with Metabolic Profiles before and after a Twelve-Week Clinical Trial in Drug-Naïve Patients with Bipolar II Disorder.

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    Sheng-Yu Lee

    Full Text Available Inflammation is thought to be involved in the pathophysiology of bipolar disorder (BP and metabolic syndrome. Prior studies evaluated the association between metabolic profiles and cytokines only during certain mood states instead of their changes during treatment. We enrolled drug-naïve patients with BP-II and investigated the correlation between changes in mood symptoms and metabolic indices with changes in plasma cytokine levels after 12 weeks of pharmacological treatment. Drug-naïve patients (n = 117 diagnosed with BP-II according to DSM-IV criteria were recruited. Metabolic profiles (cholesterol, triglyceride, HbA1C, fasting serum glucose, body mass index (BMI and plasma cytokines (TNF-α, CRP, IL-6, and TGF-β were measured at baseline and 2, 8, and 12 weeks post-treatment. To adjust within-subject dependence over repeated assessments, multiple linear regressions with generalized estimating equation methods were used. Seventy-six (65.0% patients completed the intervention. Changes in plasma CRP were significantly associated with changes in BMI (P = 1.7E-7 and triglyceride (P = 0.005 levels. Changes in plasma TGF-β1 were significantly associated with changes in BMI (P = 8.2E-6, cholesterol (P = 0.004, and triglyceride (P = 0.006 levels. However, changes in plasma TNF-α and IL-6 were not associated with changes in any of the metabolic indices. Changes in Hamilton Depression Rating Scale scores were significantly associated with changes in IL-6 (P = 0.003 levels; changes in Young Mania Rating Scale scores were significantly associated with changes in CRP (P = 0.006 and TNF-α (P = 0.039 levels. Plasma CRP and TGF-β1 levels were positively correlated with several metabolic indices in BP-II after 12 weeks of pharmacological intervention. We also hypothesize that clinical symptoms are correlated with certain cytokines. These new findings might be important evidence that inflammation is the pathophysiology

  13. Evaluation of oral stereognostic ability after rehabilitating patients with complete dentures: in vivo study.

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    Meenakshi, S; Gujjari, Anil Kumar; Thippeswamy, H N; Raghunath, N

    2014-12-01

    Stereognosis has been defined as the appreciation of the form of objects by palpation. Whilst this definition holds good for the manual exploration of objects, it is possible for the shape of objects to be explored intra orally referred to as oral stereognosis. To better understand patients' relative satisfaction with complete dentures, differences in oral stereognostic perception, based on the identification of 6 edible objects was analyzed in a group of 30 edentulous individuals at 3 stages, namely, just before (pre-treatment), 30 min after (30 min post-treatment) and 1 month after (1 month post-treatment) the insertion of new dentures. The time required to identify each object was recorded and the correctness of identification of each object was scored using oral stereognostic score. Descriptive statistics, Wilcoxon signed rank test, Spearman's rank correlation test, Pearson Chi square test was used to statistically analyze the data obtained. OSA scores was significantly increased 1 month post-treatment compared to 30 min post-treatment (p < 0.05). It was found that Oral stereognostic test is reliable for measuring patients' oral stereognostic perception and may be used as one of the clinical aids in appreciating the functional limitations imposed by the prostheses.

  14. Benefits from antidepressants: synthesis of 6-week patient-level outcomes from double-blind placebo-controlled randomized trials of fluoxetine and venlafaxine.

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    Gibbons, Robert D; Hur, Kwan; Brown, C Hendricks; Davis, John M; Mann, J John

    2012-06-01

    Some meta-analyses suggest that efficacy of antidepressants for major depression is overstated and limited to severe depression. To determine the short-term efficacy of antidepressants for treating major depressive disorder in youth, adult, and geriatric populations. Reanalysis of all intent-to-treat person-level longitudinal data during the first 6 weeks of treatment of major depressive disorder from 12 adult, 4 geriatric, and 4 youth randomized controlled trials of fluoxetine hydrochloride and 21 adult trials of venlafaxine hydrochloride. All sponsor-conducted randomized controlled trials of fluoxetine and venlafaxine. Children's Depression Rating Scale-Revised scores (youth population), Hamilton Depression Rating Scale scores (adult and geriatric populations), and estimated response and remission rates at 6 weeks were analyzed for 2635 adults, 960 geriatric patients, and 708 youths receiving fluoxetine and for 2421 adults receiving immediate-release venlafaxine and 2461 adults receiving extended-release venlafaxine. Patients in all age and drug groups had significantly greater improvement relative to control patients receiving placebo. The differential rate of improvement was largest for adults receiving fluoxetine (34.6% greater than those receiving placebo). Youths had the largest treated vs control difference in response rates (24.1%) and remission rates (30.1%), with adult differences generally in the 15.6% (remission) to 21.4% (response) range. Geriatric patients had the smallest drug-placebo differences, an 18.5% greater rate of improvement, 9.9% for response and 6.5% for remission. Immediate-release venlafaxine produced larger effects than extended-release venlafaxine. Baseline severity could not be shown to affect symptom reduction. To our knowledge, this is the first research synthesis in this area to use complete longitudinal person-level data from a large set of published and unpublished studies. The results do not support previous findings that

  15. Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study.

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    Marcus, Ronald N; Owen, Randall; Manos, George; Mankoski, Raymond; Kamen, Lisa; McQuade, Robert D; Carson, William H; Findling, Robert L

    2011-09-01

    Evaluate the long-term safety and tolerability of aripiprazole in the treatment of irritability in pediatric subjects (6-17 years) with autistic disorder. A 52-week, open-label, flexibly dosed (2-15 mg/d) study of the safety and tolerability of aripiprazole in outpatients with a DSM-IV-TR diagnosis of autistic disorder who either had completed 1 of 2 antecedent, 8-week randomized trials or were enrolled de novo (ie, not treated in the randomized trials). Safety and tolerability measures included incidences of adverse events, extrapyramidal symptoms, weight, metabolic measures, vital signs, and other clinical assessments. Subjects were enrolled between September 2006 and June 2009. Three hundred thirty subjects entered the treatment phase: 86 de novo, 174 prior aripiprazole, and 70 prior placebo. A total of 199 (60.3%) subjects completed 52 weeks of treatment. Adverse events were experienced by 286/330 subjects (86.7%). Common adverse events included weight increase, vomiting, nasopharyngitis, increased appetite, pyrexia, upper respiratory tract infection, and insomnia. Discontinuations due to adverse events occurred in 35/330 randomized subjects (10.6%)-most commonly aggression and weight increase. One patient discontinued from the study due to a laboratory-related adverse event (moderately increased alanine transaminase and aspartate transaminase). Nine subjects experienced serious adverse events-most frequently aggression. Extrapyramidal symptoms-related adverse events occurred in 48/330 subjects (14.5%)-most commonly tremor (3.0%), psychomotor hyperactivity (2.7%), akathisia (2.4%), and dyskinesia (not tardive, 2.4%). At > 9 months' aripiprazole exposure (n = 220), mean change in body weight z score was 0.33 and body mass index z score was 0.31. The percentages of subjects with clinically significant fasting metabolic abnormalities at > 9 months were 2% for glucose, 5% for total cholesterol, 7% for low-density lipoprotein cholesterol, 30% for high

  16. Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    You, Jie-Shu; Chen, Jian-Ping; Chan, Jessie S M; Lee, Ho-Fun; Wong, Mei-Kuen; Yeung, Wing-Fai; Lao, Li-Xing

    2016-07-26

    The incidence of cancer has been staying at a high level worldwide in recent years. With advances in cancer diagnosis and therapy strategy, the survival rate of patients with cancer has been increasing, but the side effects of these treatments, especially chemotherapy, are obvious even when the chemotherapy ceases. YH0618, a prescription, has showed efficacy in reducing chemotherapy-induced toxicity through long clinical practice. However, there is no scientific research exploring the effects of YH0618 in patients with cancer. Therefore, using a randomized controlled trial, this study will explore the efficacy of YH0618 on ameliorating chemotherapy-induced toxicity including dermatologic toxicity, myelosuppression, hepatotoxicity and nephrotoxicity and improving fatigue in cancer patients who have completed chemotherapy. This is a prospective assessor-blinded, parallel, randomized controlled trial. Patients with cancer at any stage who have completed chemotherapy within two weeks will be randomly divided into group A (YH0618) and group B (wait-list) using a 1:1 allocation ratio. The chemotherapeutic agents include taxanes or anthracyclines. Subjects assigned to group A will receive YH0618 soup 6 days a week for 6 weeks and uncontrolled follow-up for 6 weeks, while group B are required to wait for 6 weeks before receiving YH0618 intervention. The primary outcome of this study is the incidence of protocol-specified grade ≥2 dermatologic toxicities graded by NCI CTCAE Chinese version 4.0 and changes of fingernail color, face skin color and tongue color evaluated by the L*a*b system within 6 weeks. There are some secondary outcomes associated with dermatologic toxicity including fatigue and clinical objective examination. There are few scientific and safe methods in ameliorating chemotherapy-induced toxicity. The proposed study may provide direct and convincing evidence to support YH0618 as an adjuvant treatment for reducing chemotherapy-induced toxicity, which

  17. Recovery of Visual Function in a Patient with an Onodi Cell Mucocele Compressive Optic Neuropathy Who Had a 5-Week Interval between Onset and Surgical Intervention: A Case Report

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    Wencan Wu

    2010-01-01

    Full Text Available Purpose. To report on a patient with compressive optic neuropathy secondary to an Onodi cell mucocele, who fully recovered visual function following surgery. Method. Case report. Results. A 28-year-old male was admitted with a right visual acuity of 20/100 following treatment for an initial diagnosis of optic neuritis. Subsequent examination suggested compressive optic neuropathy, and neuroimaging confirmed the presence of an Onodi mucocele compressing the optic nerve. The patient underwent a right endonasal sphenoethmoidectomy with decompression 5 weeks after the initial onset of symptoms. Three weeks following surgery, the visual acuity was 20/20, and there was complete resolution of the visual field defect, which has remained stable at 1 year. Conclusion. Onodi cell mucocele should be included in the differential diagnosis of a young patient with compressive optic neuropathy. Surgical decompression should be considered even when symptoms have been present for over a month.

  18. Customized Cheek Plumper with Friction Lock Attachment for a Completely Edentulous Patient to Enhance Esthetics: A Clinical Report.

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    Bhushan, Prem; Aras, Meena A; Coutinho, Ivy; Rajagopal, Praveen; Mysore, Ashwin R; Kumar, Swati

    2017-01-25

    Prosthetic rehabilitation of a completely edentulous patient should never be restricted to the replacement of missing teeth. The ultimate aim of complete denture treatment should be restoration of the full range of oral functions and esthetics. Slumped cheeks are always a concern for esthetically demanding complete denture patients. This article describes a simple, scientific, cost-effective technique to improve facial esthetics in a completely edentulous patient with the help of a cheek plumper. The technique used here implements the concept of neutral zone to precisely determine the amount of space available for the cheek plumper. The simple friction lock attachments that retained the cheek plumpers on the prosthesis were also fabricated after determining the space available in the appropriate areas. Thus an effort was made to keep the cheek plumpers unobtrusive yet effective to ensure complete integration of the prosthesis into the stomatognathic system. © 2017 by the American College of Prosthodontists.

  19. The effectiveness and safety of amisulpride in Chinese patients with schizophrenia: An 8‐week, prospective, open‐label, multicenter, single‐arm study

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    Liang, Ying; Cao, Changan; Zhu, Cheng; Wang, Chuanyue; Zhang, Congpei; Dong, Fang; Yang, Fude; Deng, Hong; Yu, Jingjie; Tang, Jisheng; Su, Lei; Xin, Limin; Hong, Ling; Gao, Minglong; Tang, Muni; Xie, Shiping; Lu, Shuiping; Liu, Tiebang; Xu, Xiaojin; Wang, Xijin; Li, Xuanzi; Wang, Xueyi; Li, Yi; Zhang, Yong; Chen, Zhiyu

    2016-01-01

    Abstract Introduction This study evaluated the effectiveness and safety of amisulpride in Chinese schizophrenia patients. Methods A multicenter, single‐arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Results A total of 316 patients were enrolled; 295 were included in the effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Nine patients discontinued treatment because of adverse events. Discussion Amisulpride had clinical effectiveness and was relatively well tolerated in Chinese patients with schizophrenia. PMID:27020720

  20. Cholecalciferol 20 000 IU Once Weekly in HIV-Positive Patients with Low Vitamin D Levels: Result from a Cohort Study.

    Science.gov (United States)

    Noe, Sebastian; Heldwein, Silke; Pascucchi, Rita; Oldenbüttel, Celia; Wiese, C; von Krosigk, Ariane; Jägel-Guedes, Eva; Jäger, Hans; Mayer, Wolfgang; Spinner, Christoph D; Wolf, Eva

    To evaluate efficacy and safety of 20 000 IU cholecalciferol weekly in HIV-infected patients. Longitudinal data for 243 HIV-infected patients with paired 25-OH-vitamin D3 values for the same month in 2 consecutive years were stratified by the initiation of supplementation in this retrospective study. After 1 year of administration of cholecalciferol 20 000 IU weekly, about 78% of patients with initial vitamin D level L achieved vitamin D levels >20 µg/L and 42% achieved levels >30 µg/L. Supplemented patients with baseline vitamin D levels L showed a significant risk reduction for hypocalcemia ( P = .006; risk difference: 20.8%) and a significantly lower increase in alkaline phosphatase (AP) compared to those in the nonsubstituted group. The dose of 20 000 IU of cholecalciferol once weekly was found to be safe and effective. Normalization of vitamin D levels within 1 year was observed in 42% to 75% of the patients.

  1. The Hepatitis C treatment experience: Patients' perceptions of the facilitators of and barriers to uptake, adherence and completion.

    Science.gov (United States)

    Sublette, Victoria A; Smith, Sian K; George, Jacob; McCaffery, Kirsten; Douglas, Mark W

    2015-01-01

    This study explores the perceptions of patients receiving treatment for Hepatitis C to determine what factors influence their decision to commence treatment, ability to maintain adherence and complete their treatment program. Semi-structured interview techniques were used in a qualitative study of 20 patients undergoing treatment for Chronic Hepatitis C (CHC). To explore patients' perceived barriers and facilitators of Hepatitis C treatment adherence and completion. Analysis of patient interviews identified four key themes: (1) motivations for commencing CHC treatment - fear of death and ridding themselves of stigma and shame; (2) the influential role of provider communication - patients reported that information and feedback that was personalised to their needs and lifestyles was the most effective for improving adherence to treatment; (3) facilitators of treatment adherence and completion - social, emotional and practical support improved adherence and completion, as did temporarily ceasing employment; (4) barriers to treatment adherence and completion - these included side effects, stigma, a complicated dosing schedule and limitations of the public healthcare system. To increase treatment adherence and completion rates, a patient-centred approach is required that addresses patients' social, practical, and emotional support needs and adaptive coping strategies.

  2. Long-term safety and effectiveness of once-daily, single-entity, extended-release hydrocodone over 76 weeks of an open-label study in patients with chronic noncancer and nonneuropathic pain.

    Science.gov (United States)

    Taber, Louise; Lynch, Shau Yu; He, Ellie; Ripa, Steven R

    2016-01-01

    To evaluate long-term use of Hysingla(®) ER (HYD), a single-entity, extended-release, once-daily hydrocodone bitartrate tablet with abuse-deterrent properties in patients with moderate-to-severe chronic noncancer and nonneuropathic pain. This open-label study consisted of a dose-titration period (up to 45 days), a 52-week maintenance period and a 24-week extension period. Opioid-naïve or opioid-experienced patients with controlled or uncontrolled chronic pain conditions were treated with HYD 20-120 mg daily. Supplemental nonopioid and short-acting opioid analgesics were permitted. This paper presents the results of 106 patients who continued HYD treatment for up to 76 weeks. Primary safety measures included the incidence of adverse events, as well as audiologic, clinical laboratory and electrocardiogram measurements. Effectiveness was measured by the change between baseline and the overall 76-week treatment period in "average pain over the last 24 h" (0 = no pain, 10 = pain as bad as you can imagine), Brief Pain Inventory-Short Form survey, Medical Outcomes Study 36-Item Short Form Health Survey, Medical Outcomes Study Sleep Scale-Revised and concomitant nonstudy opioid analgesic use. Among 410 patients who completed the maintenance period, 106 continued into the extension. Of these, 83 (78%) completed the entire 76-week treatment period. Treatment-emergent adverse events were typical of those observed with μ-opioid agonists. No study drug abuse or diversion was reported. Clinically important analgesia and functional improvement were achieved during the dose-titration period and were maintained in most patients throughout 76 weeks without the need for continued HYD dose increases or changes in concomitant nonstudy opioid analgesics. The mean pain score was 6.1 at baseline, 3.8 at the end of the dose titration period and 3.8 through 76 weeks. HYD was generally well tolerated. No unexpected safety concerns emerged. Pain control was sustained throughout 76 weeks of

  3. Anxiety and Anger Symptoms in Hwabyung Patients Improved More following 4 Weeks of the Emotional Freedom Technique Program Compared to the Progressive Muscle Relaxation Program: A Randomized Controlled Trial

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    Jin Woo Suh

    2015-01-01

    Full Text Available Background. The Emotional Freedom Technique (EFT is a meridian-based psychological therapy. The present clinical trial investigates the effectiveness of EFT as a new treatment option for Hwabyung (HB patients experiencing anger and compares the efficacy to the Progressive Muscle Relaxation (PMR, the conventional meditation technique. Methods. The EFT and progressive muscle relaxation (PMR methods were performed on 27 HB patients, and their capacities to alleviate anxiety, anger, and emotional status were compared. After a 4-week program, a survey was conducted; patients then completed a self-training program for 4 weeks, followed by a second survey. Results. During the initial 4 weeks, the EFT group experienced a significant decrease in the HB symptom scale, anger state, and paranoia ideation (p<0.05. Over the entire 9-week interval, there were significant decreases in the HB symptom scale, anxiety state, anger state, anger trait, somatization, anxiety, hostility, and so on in EFT group (p<0.05. Conclusion. The EFT group showed improved psychological symptoms and physical symptoms greater than those observed in the PMR group. EFT more effectively alleviated HB symptoms compared to PMR. EFT group showed better maintenance during self-training, suggesting good model of self-control treatment in HB patients.

  4. A study to evaluate the location and frequency of denture-related ulcerations and postinsertion adjustments in complete denture patients

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    Saurabh Jain

    2017-01-01

    Full Text Available Background and Aims: Removable complete denture is one of the most common treatment modalities for completely edentulous patients. After denture insertion, patient very often faces problems with the denture even after complete care is taken during fabrication procedure. Most common complaint is traumatic ulcers. The present study aimed to locate the most common areas of ulcerations due to complete dentures, how frequently they occur and how many times patient visits for adjustment after insertion of complete denture. Materials and Methods: Two hundred and twenty-one patients were selected and were delivered complete dentures. Dentures were fabricated for all the patients. Each step of denture fabrication was controlled and guided by a prosthodontist. After placement of dentures, patients were evaluated at every recall visit and their dentures were adjusted. All the details of each visit (area of ulceration and number of visits were recorded in a self-designed format. Descriptive statistical analysis was done using SPSS version 13 software. Chi-squared test was used to evaluate the correlation between mucosal injuries and postinsertion day and the relationship between lesions, patient age, and patient gender. Results: All the 221 patients required denture adjustment due to mucosal injuries. No significant difference was found between denture-related injuries between males and females. Injuries related to mandibular dentures were significantly higher than those related to maxillary dentures. In mandible, the most common area of mucosal injury is posterior one-third of alveololingual sulcus; while in maxilla, the most common area of mucosal injury is labial frenum. Conclusion: Postinsertion adjustments are an important aspect of rehabilitating patient with complete dentures. Most of the denture-related injuries were in limiting areas. Proper border molding techniques, accurate secondary impressions, and use of pressure indicating paste during

  5. Comparing the Efficacy of 8 Weeks Treatment of Cipram® and its Generic Citalopram in Patients With Mixed Anxiety-Depressive Disorder.

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    Khoonsari, Hasan; Oghazian, Mohammad Bagher; Kargar, Mona; Moin, Mahdiyeh; Khalili, Hossein; Alimadadi, Abbas; Torkamandi, Hassan; Ghaeli, Padideh

    2015-06-01

    Patients with mixed anxiety-depressive disorder (MADD) suffer both anxiety and depression. Antidepressants, especially, selective serotonin reuptake inhibitors are among agents of choice for treating this condition. This study compared the efficacy of Cipram® with its generic, citalopram. Forty adult outpatients (between 18 to 55 years of age) with a diagnosis of MADD who met the trial criteria, entered this double-blind, randomized study. Subjects were assigned to receive either generic citalopram or Cipram® for 8 weeks. Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) were utilized to assess depression and anxiety at baseline, weeks 4 and 8 of the study. Statistical analysis was performed using SPSS 14.0. Twenty patients received citalopram (mean dosages of 22 mg/day during the first 4 weeks and 33 mg/day during weeks 4 to 8) and 20 received Cipram® (mean dosages of 22 mg/day during the first 4 weeks and 29 mg/day during weeks 4 to 8). Both treatments were noted to be effective in improving the symptoms of MADD at weeks 4 and 8. The mean differences of HAM-D and HAM-A between Citalopram and Cipram® groups were significantly different at the end of week 4 (HAM-D: P = 0.038, HAM-A: P = 0.025), but not at the end of week 8 (HAM-D: P = 0.239, HAM-A: P = 0.204). Both medications were tolerated well by the patients. This study suggests that the efficacy of citalopram is similar to that of Cipram® in the treatment of MADD after 8 weeks. Meanwhile, Cipram® may reduce depression and anxiety quicker than its generic, citalopram.

  6. Feasibility and efficacy of accelerated weekly concomitant boost postoperative radiation therapy combined with concomitant chemotherapy in patients with locally advanced head and neck cancer.

    Science.gov (United States)

    Pehlivan, Berrin; Luthi, Francois; Matzinger, Oscar; Betz, Michael; Dragusanu, Daniela; Bulling, Shelley; Bron, Luc; Pasche, Philippe; Seelentag, Walter; Mirimanoff, René O; Zouhair, Abderrahim; Ozsahin, Mahmut

    2009-05-01

    The aim of this study was to assess feasibility and efficacy of weekly concomitant boost accelerated postoperative radiation therapy (PORT) with concomitant chemotherapy (CT) in patients with locally advanced head and neck cancer (LAHNC). Conformal or intensity-modulated 66-Gy RT was performed in 5.5 weeks in 40 patients. Cisplatin was given at days 1, 22, and 43. Median follow-up was 36 months. Grade 3 mucositis, dysphagia, and erythema was observed in ten (25%), nine (23%), and six (13%) patients, respectively. Grade 3 or more anemia was observed in two (6%) patients, and leukopenia in five (13%) patients. No grade 3 or 4 thrombocytopenia was observed. Grade 3 nephrotoxicity was observed in one patient (3%). No treatment-related mortality was observed. Grade 2 or more xerostomia and edema were observed in ten (25%) and one (3%) patient, respectively. Locoregional relapse occurred in eight patients, and seven patients developed distant metastases. Median time to locoregional relapse was 6 months. Three-year overall, disease-free survival, and locoregional control rates were 63%, 62%, and 81%, respectively. Multivariate analysis revealed that the only prognostic factor was nodal status. Reducing overall treatment time using accelerated PORT/CT by weekly concomitant boost (six fractions per week) combined with concomitant cisplatin CT is easily feasible with acceptable morbidity.

  7. Muscle hypertrophy as the presenting sign in a patient with a complete FHL1 deletion.

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    Willis, T A; Wood, C L; Hudson, J; Polvikoski, T; Barresi, R; Lochmüller, H; Bushby, K; Straub, V

    2016-08-01

    Four and a half LIM protein 1 (FHL1/SLIM1) has recently been identified as the causative gene mutated in four distinct diseases affecting skeletal muscle that have overlapping features, including reducing body myopathy, X-linked myopathy, X-linked dominant scapuloperoneal myopathy and Emery-Dreifuss muscular dystrophy. FHL1 localises to the sarcomere and the sarcolemma and is believed to participate in muscle growth and differentiation as well as in sarcomere assembly. We describe in this case report a boy with a deletion of the entire FHL1 gene who is now 15 years of age and presented with muscle hypertrophy, reduced subcutaneous fat, rigid spine and short stature. This case is the first, to our knowledge, with a complete loss of the FHL1 protein and MAP7D3 in combination. It supports the theory that dominant negative effects (accumulation of cytotoxic-mutated FHL1 protein) worsen the pathogenesis. It extends the phenotype of FHL1-related myopathies and should prompt future testing in undiagnosed patients who present with unexplained muscle hypertrophy, contractures and rigid spine, particularly if male. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis.

    Science.gov (United States)

    Merola, Joseph F; Elewski, Boni; Tatulych, Svitlana; Lan, Shuping; Tallman, Anna; Kaur, Mandeep

    2017-07-01

    Tofacitinib is an oral Janus kinase inhibitor. Efficacy and safety of tofacitinib in patients with moderate-to-severe plaque psoriasis have been demonstrated. We sought to assess the efficacy of tofacitinib for the treatment of nail psoriasis over a period of 52 weeks. In 2 identical phase 3 studies (OPT Pivotal 1 and 2), patients were randomized 2:2:1 to receive tofacitinib 5 mg, tofacitinib 10 mg, or placebo, twice daily. At week 16, placebo-treated patients were re-randomized to tofacitinib. This post hoc analysis of patients with existing nail psoriasis assessed the Nail Psoriasis Severity Index (NAPSI) score and proportions of patients achieving ≥50% reduction in NAPSI from baseline (NAPSI50), NAPSI75, or NAPSI100. Baseline mean NAPSI scores for patients treated with tofacitinib 5 mg (N = 487), tofacitinib 10 mg (N = 476), and placebo (N = 233) twice daily were 27.0, 27.3, and 26.9, respectively. At week 16, significantly (all P psoriasis versus placebo at week 16; improvements were maintained over 52 weeks [NCT01276639; NCT01309737]. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  9. 96 Week Follow-Up of HIV-Infected Patients in Rescue with Raltegravir Plus Optimized Backbone Regimens: A Multicentre Italian Experience

    Science.gov (United States)

    Capetti, Amedeo; Landonio, Simona; Meraviglia, Paola; Di Biagio, Antonio; Lo Caputo, Sergio; Sterrantino, Gaetana; Ammassari, Adriana; Menzaghi, Barbara; Franzetti, Marco; De Socio, Giuseppe Vittorio; Pellicanò, Giovanni; Mazzotta, Elena; Soria, Alessandro; Meschiari, Marianna; Trezzi, Michele; Sasset, Lolita; Celesia, Benedetto Maurizio; Zucchi, Patrizia; Melzi, Sara; Ricci, Elena; Rizzardini, Giuliano

    2012-01-01

    Background Long term efficacy of raltegravir (RAL)-including regimens in highly pre-treated HIV-1-infected patients has been demonstrated in registration trials. However, few studies have assessed durability in routine clinical settings. Methods Antiretroviral treatment-experienced patients initiating a RAL-containing salvage regimen were enrolled. Routine clinical and laboratory follow-up was performed at baseline, week 4, 12, and every 12 weeks thereafter. Data were censored at week 96. Results Out of 320 patients enrolled, 292 (91.25%) subjects maintained their initial regimen for 96 weeks; 28 discontinued prematurely for various reasons: death (11), viral failure (8), adverse events (5), loss to follow-up (3), consent withdrawal (1). Eight among these 28 subjects maintained RAL but changed the accompanying drugs. The mean CD4+ T-cell increase at week 96 was 227/mm3; 273 out of 300 patients (91%), who were still receiving RAL at week 96, achieved viral suppression (HIV-1 RNA 4 (n = 40), CD4+ T-cell gain was similar across strata: +270, +214, +216, and +240 cells/mm3, respectively, as was the proportion of subjects with undetectable viral load. Laboratory abnormalities (elevation of liver enzymes, total cholesterol and triglycerides) were rare, ranging from 0.9 to 3.1%. The mean 96-week total cholesterol increase was 23.6 mg/dL. Conclusions In a routine clinical setting, a RAL-based regimen allowed most patients in salvage therapy to achieve optimal viral suppression for at least 96 weeks, with relevant immunologic gain and very few adverse events. PMID:22808029

  10. 96 Week follow-up of HIV-infected patients in rescue with raltegravir plus optimized backbone regimens: a multicentre Italian experience.

    Directory of Open Access Journals (Sweden)

    Amedeo Capetti

    Full Text Available BACKGROUND: Long term efficacy of raltegravir (RAL-including regimens in highly pre-treated HIV-1-infected patients has been demonstrated in registration trials. However, few studies have assessed durability in routine clinical settings. METHODS: Antiretroviral treatment-experienced patients initiating a RAL-containing salvage regimen were enrolled. Routine clinical and laboratory follow-up was performed at baseline, week 4, 12, and every 12 weeks thereafter. Data were censored at week 96. RESULTS: Out of 320 patients enrolled, 292 (91.25% subjects maintained their initial regimen for 96 weeks; 28 discontinued prematurely for various reasons: death (11, viral failure (8, adverse events (5, loss to follow-up (3, consent withdrawal (1. Eight among these 28 subjects maintained RAL but changed the accompanying drugs. The mean CD4+ T-cell increase at week 96 was 227/mm(3; 273 out of 300 patients (91%, who were still receiving RAL at week 96, achieved viral suppression (HIV-1 RNA 4 (n = 40, CD4+ T-cell gain was similar across strata: +270, +214, +216, and +240 cells/mm(3, respectively, as was the proportion of subjects with undetectable viral load. Laboratory abnormalities (elevation of liver enzymes, total cholesterol and triglycerides were rare, ranging from 0.9 to 3.1%. The mean 96-week total cholesterol increase was 23.6 mg/dL. CONCLUSIONS: In a routine clinical setting, a RAL-based regimen allowed most patients in salvage therapy to achieve optimal viral suppression for at least 96 weeks, with relevant immunologic gain and very few adverse events.

  11. Evaluation of the Chinese herbal medicine Jinlida in type 2 diabetes patients based on stratification: Results of subgroup analysis from a 12-week trial.

    Science.gov (United States)

    Tian, Jiaxing; Lian, Fengmei; Yang, Libo; Tong, Xiaolin

    2018-02-01

    The Chinese herbal medicine Jinlida can significantly enhance the hypoglycemic action of metformin. However, the population showing the best responses to Jinlida has not been clarified. The aim of the present study was to compare the efficacy of Jinlida in type 2 diabetes mellitus (T2DM) after stratification. Data were analyzed from a 12-week randomized placebo-controlled double-blind multicenter study with 192 T2DM patients (186 completed the study). The efficacy evaluation included HbA1c, fasting plasma glucose (FPG), and 2-h postprandial glucose (2hPG) levels stratified by baseline HbA1c, sex, age, body mass index (BMI), and duration of T2DM diagnosis. Homeostasis model assessment of insulin resistance (HOMA-IR) and homeostatic model assessment of β-cell function (HOMA-β) were also evaluated stratified by baseline insulin levels. In the Jinlida group, HbA1c was significantly reduced (P 8.5%, in males and in those aged >60 years, with a BMI ≤24 kg/m 2 , or with a duration of T2DM diagnosis >5 years (P Jinlida significantly alleviated insulin resistance (P 20 mU/L. Jinlida also significantly improved β-cell function in patients with baseline insulin levels ≤20 mU/L (P Jinlida significantly improved glycemic control, with greater improvements in patients with poor glycemic control and male, elderly, of normal weight, or with a long disease course. Furthermore, Jinlida alleviated insulin resistance with hyperinsulinemia and promoted insulin secretion with hypoinsulinemia. These results need to be further confirmed in clinical trials. © 2017 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

  12. Weekly low-dose docetaxel is an effective treatment with fewer adverse events for metastatic castration-resistant prostate cancer in Taiwanese patients

    Directory of Open Access Journals (Sweden)

    Cheng-Li Kao

    2015-12-01

    Conclusion: For Taiwanese mCRPC patients, weekly DTX 30 mg/m2 is an efficient regimen for disease control with relatively low Grade 3 or 4 hematological adverse effects. The proper treatment duration of DTX therapy for mCRPC in Taiwanese patients is still uncertain, so further research is needed.

  13. Heart rate acceleration with GLP-1 receptor agonists in type 2 diabetes patients : an acute and 12-week randomised, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, T.; Kramer, Mark H H; Diamant, Michaela; van Raalte, Daniël H

    OBJECTIVE: To examine mechanisms underlying resting heart rate (RHR) increments of GLP-1 receptor agonists in type 2 diabetes patients. DESIGN: Acute and 12-week randomised, placebo-controlled, double-blind, single-centre, parallel-group trial. METHODS: In total, 57 type 2 diabetes patients

  14. Manipulation Therapy Relieved Pain More Rapidly Than Acupuncture among Lateral Epicondylalgia (Tennis Elbow Patients: A Randomized Controlled Trial with 8-Week Follow-Up

    Directory of Open Access Journals (Sweden)

    Chung-Yuan Hsu

    2016-01-01

    Full Text Available Radial bone adjustment manipulation treatment may be effective to reduce pain rapidly in lateral epicondylalgia patients and the pathological tension in the biceps brachii muscle is highly concerned. To prove this hypothesis, we conducted a randomized controlled trial and included 35 patients with lateral epicondylalgia for more than 2 months. Either manipulation treatment (n=16 or acupuncture (n=19 was given to these patients for 2 weeks and all patients’ symptoms were followed up for 8 weeks after treatment. Both groups demonstrated changes in pain VAS score, grip strength, and DASH questionnaire. Lateral epicondylalgia patients who received manipulation treatment felt pain relief sooner than those who had acupuncture treatments during the first few treatments. However, both acupuncture and manipulation are effective, while the difference has no significance at the 8-week follow-up. The trial was registered with Current Controlled Trials ISRCTN81308551 on 5 February 2016.

  15. Elective caesarean section at 38 weeks versus 39 weeks

    DEFF Research Database (Denmark)

    Glavind, Julie; Kindberg, S F; Uldbjerg, N

    2013-01-01

    To investigate whether elective caesarean section before 39 completed weeks of gestation increases the risk of adverse neonatal or maternal outcomes.......To investigate whether elective caesarean section before 39 completed weeks of gestation increases the risk of adverse neonatal or maternal outcomes....

  16. Long-Term Complete Remission with nab-Paclitaxel, Bevacizumab, and Gemcitabine Combination Therapy in a Patient with Triple-Negative Metastatic Breast Cancer

    Directory of Open Access Journals (Sweden)

    Alberto Montero

    2012-12-01

    Full Text Available This is a case study of a 52-year-old female patient diagnosed in June 2007 with primary metastatic invasive ductal carcinoma of the left breast and synchronous metastases in the bone, lymph nodes, and lung. Biopsy results of the tumor tissue were negative for the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2. In November 2007, she participated in a phase II study of metastatic HER2-negative breast cancer. Treatment consisted of systemic chemotherapy with gemcitabine 1,500 mg/m2, nab-paclitaxel 150 mg/m2, and bevacizumab 10 mg/kg once every other week. The patient experienced pain relief in her sternum after 5 weeks of chemotherapy, and her analgesic therapy was discontinued. After 7 months, the patient achieved a complete radiographic response, which was maintained for nearly 2 additional years. She continued receiving treatment throughout this period, requiring 1 dose reduction due to fatigue. The patient experienced no other adverse events, including neuropathy, and continued working uninterrupted throughout her treatment. The patient was discontinued from the study in May 2010 after disease progression, almost a full 3 years after diagnosis. The patient showed minimal response to subsequent therapies but had disease stabilization and died from her disease in April 2012. Median overall survival for patients with metastatic triple-negative breast cancer is between 12 and 13.3 months. This patient survived nearly 5 years following diagnosis. This case exemplifies how therapy with nab-paclitaxel, bevacizumab, and gemcitabine may prolong survival, with minimal toxicity, in select patients with triple-negative metastatic breast cancer.

  17. Comparison of circadian, weekly, and seasonal variations of electrical storms and single events of ventricular fibrillation in patients with Brugada syndrome

    Directory of Open Access Journals (Sweden)

    Yoshiyasu Aizawa

    2016-06-01

    Full Text Available In patients with Brugada syndrome (BS, VF occurred predominantly during the nocturnal period. Some patients also developed ESs. In addition to the circadian rhythm, patients showed weekly and seasonal patterns. The patients with ESs had peak episodes of VF on Saturday and in the winter and spring, while episodes of VF in patients with single VF events occurred most often on Monday with smaller seasonal variation. Except for age, there was no difference in the clinical or ECG characteristics between the patients with ESs and those with single VF episodes.

  18. Effect of an intraoral retrusion plate on maxillary arch dimensions in complete bilateral cleft lip and palate patients

    NARCIS (Netherlands)

    Oosterkamp, B.C.; van Oort, R.P.; Dijkstra, P.U.; Stellingsma, K.; Bierman, M.W.; de Bont, L.G.

    Objective: The aim of this study was to analyze maxillary arch dimensions in patients with complete bilateral cleft lip and palate treated with an intraoral retrusion plate prior to lip closure. Patients: The effects of the intraoral retrusion plate were evaluated on serially obtained maxillary

  19. Body representation disturbances in visual perception and affordance perception persist in eating disorder patients after completing treatment

    NARCIS (Netherlands)

    Engel, Manja M; Keizer, Anouk

    2017-01-01

    Body image disturbances (BID) are a key feature of eating disorders (ED). Clinical experience shows that BID exists in patients who Completed their Eating Disorder Treatment (CEDT), however studies concerning BID in CEDT patients are often limited to cognition and affect, measured by interviews and

  20. Assessment of nostril symmetry after primary cleft rhinoplasty in patients with complete unilateral cleft lip and palate

    NARCIS (Netherlands)

    Reddy, S.G.; Devarakonda, V.; Reddy, RR

    2013-01-01

    The aim of this study was to assess the nostril symmetry following primary cleft rhinoplasty done with either a dorsal onlay or columellar strut graft in patients with non-syndromic complete unilateral cleft lip and palate. In this retrospective study 30 consecutive patients treated with autogenous

  1. Complete en bloc urinary exenteration for synchronous multicentric transitional cell carcinoma with sarcomatoid features in a hemodialysis patient

    Directory of Open Access Journals (Sweden)

    Tiberio M. Siqueira Jr

    2006-10-01

    Full Text Available The incidence of transitional cell carcinoma (TCC in patients submitted to hemodialysis is low. The presence of TCC with sarcomatoid features in this cohort is even scarcer. Herein, we describe a very rare case of synchronous multicentric muscle invasive bladder carcinoma with prostate invasion in a hemodialysis patient, submitted to complete en bloc urinary exenteration.

  2. TRPA1 polymorphisms in chronic and complete spinal cord injury patients with neuropathic pain: a pilot study.

    Science.gov (United States)

    Vidal Rodriguez, Sonia; Castillo Aguilar, Inmaculada; Cuesta Villa, Luis; Serrano Saenz de Tejada, Francisco

    2017-01-01

    Pilot study. Single-nucleotide polymorphisms (SNPs) in TRPA1 gene are related to the etiology of chronic pain. The study is a pilot study with the primary objective of analyzing these SNPs in Spanish patients with chronic and complete spinal cord injury (SCI) and neuropathic pain (NPP). Asepeyo Hospital Department of Chronic and Complete SCI. Twelve patients with chronic and complete SCI and NPP, and 12 patients with chronic and complete SCI with no pain were reviewed. International Spinal Cord Injury Pain Classification (LANSS) and visual analog score (VAS) were chosen to classify pain syndrome. SNPs were identified by melting analysis after DNA amplification with real-time fluorescence PCR. There were differences in rs11988795 variant: GG homozygous ( p  = 0.01) and G allele ( p  = 0.001) were more frequent in SCI patients with no pain. There were differences in rs13255063 variant: TT homozygous were prevalent ( p  = 0.03) in patients with NPP. Until now this is the first study to show a description of TRPA1 SNPs in Spanish patients with chronic and complete SCI and NPP. These results suggest that GG genotype in rs11988795 variant and G allele could be protective factors against NPP. TT genotype in rs13255063 variant could be a risk factor for NPP. Neuropathic pain after spinal cord injuries may have genetic contributions.

  3. An 8-Week Knee Osteoarthritis Treatment Program of Hyaluronic Acid Injection, Deliberate Physical Rehabilitation, and Patient Education is Cost Effective at 2 Years Follow-up: The OsteoArthritis Centers of America Experience

    Directory of Open Access Journals (Sweden)

    Larry E. Miller

    2014-01-01

    Full Text Available Numerous nonsurgical interventions have been reported to improve symptoms of knee osteoarthritis (OA over the short term. However, longer follow-up is required to accurately characterize outcomes such as cost effectiveness and delayed arthroplasty. A total of 553 patients with symptomatic knee OA who previously underwent a single 8-week multimodal treatment program were contacted at 1 year ( n = 336 or 2 years ( n = 217 follow-up. The percentage of patients who underwent knee arthroplasty was 10% at 1 year and 18% at 2 years following program completion. The treatment program was highly cost effective at $12,800 per quality-adjusted life year at 2 years. Cost effectiveness was maintained under a variety of plausible assumptions and regardless of gender, age, body mass index, disease severity, or knee pain severity. In summary, a single 8-week multimodal knee OA treatment program is cost effective and may lower knee arthroplasty utilization through 2 years follow-up.

  4. Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.

    Science.gov (United States)

    Nauck, Michael A; Stewart, Murray W; Perkins, Christopher; Jones-Leone, Angela; Yang, Fred; Perry, Caroline; Reinhardt, Rickey R; Rendell, Marc

    2016-02-01

    Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated albiglutide as monotherapy. In this placebo-controlled study, 309 patients (aged ≥ 18 years) with type 2 diabetes inadequately controlled by diet and exercise and who were not using a glucose-lowering agent (HbA1c 7.0-10.0% [53.00-85.79 mmol/mol], body mass index 20-45 kg/m(2), and fasting C-peptide ≥ 0.26 nmol/l) were randomised (1:1:1 on a fixed randomisation schedule using an interactive voice response system) to receive once-weekly albiglutide 30 mg (n = 102) or 50 mg (n = 102) or matching placebo (n = 105). The study treatments were blinded to both patients and study personnel. All study data were collected at individual patient clinic visits. The primary efficacy endpoint was change in HbA1c from baseline to week 52. The primary analysis was applied to the intent-to-treat population. Additional efficacy and safety endpoints were assessed. At week 52, both albiglutide 30 mg and 50 mg were superior to placebo in reducing HbA1c. The least-squares means treatment difference from placebo was -0.84% (95% CI -1.11%, -0.58%; p < 0.0001) with albiglutide 30 mg and -1.04% (-1.31%, -0.77%; p < 0.0001) with albiglutide 50 mg. Injection-site reactions were reported more frequently with albiglutide (30 mg: 17.8%; 50 mg: 22.2%) than with placebo (9.9%). Other commonly reported adverse events included nausea, diarrhoea, vomiting and hypoglycaemia; the incidences of these were generally similar across treatment groups. Albiglutide is safe and effective as monotherapy and significantly lowered HbA1c levels over 52 weeks, did not cause weight gain, and had good gastrointestinal tolerability and a low rate of hypoglycaemia compared with placebo. Trial registration ClinicalTrials.gov NCT00849017 Funding This study was sponsored by GlaxoSmithKline.

  5. Complete surgical resection improves outcome in INRG high-risk patients with localized neuroblastoma older than 18 months.

    Science.gov (United States)

    Fischer, Janina; Pohl, Alexandra; Volland, Ruth; Hero, Barbara; Dübbers, Martin; Cernaianu, Grigore; Berthold, Frank; von Schweinitz, Dietrich; Simon, Thorsten

    2017-08-04

    Although several studies have been conducted on the role of surgery in localized neuroblastoma, the impact of surgical timing and extent of primary tumor resection on outcome in high-risk patients remains controversial. Patients from the German neuroblastoma trial NB97 with localized neuroblastoma INSS stage 1-3 age > 18 months were included for retrospective analysis. Imaging reports were reviewed by two independent physicians for Image Defined Risk Factors (IDRF). Operation notes and corresponding imaging reports were analyzed for surgical radicality. The extent of tumor resection was classified as complete resection (95-100%), gross total resection (90-95%), incomplete resection (50-90%), and biopsy (Neuroblastoma Risk Group (INRG) staging system. Survival curves were estimated according to the method of Kaplan and Meier and compared by the log-rank test. A total of 179 patients were included in this study. 77 patients underwent more than one primary tumor operation. After best surgery, 68.7% of patients achieved complete resection of the primary tumor, 16.8% gross total resection, 14.0% incomplete surgery, and 0.5% biopsy only. The cumulative complication rate was 20.3% and the surgery associated mortality rate was 1.1%. Image defined risk factors (IDRF) predicted the extent of resection. Patients with complete resection had a better local-progression-free survival (LPFS), event-free survival (EFS) and OS (overall survival) than the other groups. Subgroup analyses showed better EFS, LPFS and OS for patients with complete resection in INRG high-risk patients. Multivariable analyses revealed resection (complete vs. other), and MYCN (non-amplified vs. amplified) as independent prognostic factors for EFS, LPFS and OS. In patients with localized neuroblastoma age 18 months or older, especially in INRG high-risk patients harboring MYCN amplification, extended surgery of the primary tumor site improved local control rate and survival with an acceptable risk of

  6. Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study

    Directory of Open Access Journals (Sweden)

    Zhao JP

    2017-08-01

    Full Text Available Jingping Zhao,1,* Lehua Li,1,* Jianguo Shi,2 Yi Li,3 Xiufeng Xu,4 Keqing Li,5 Lili Zhang,6 Shangli Cai,6 Yu Feng,6 Jianmin Zhuo,6 Weihong Liu,6 Huafei Lu6 1Department of Psychiatry, The Mental Health Institute, The Second Xiangya Hospital of Central South University, 2Department of Psychiatry, Mental Health Center of Xi’an City, 3Department of Psychiatry, Mental Health Center of Wuhan City, 4Department of Psychiatry, First Affiliated Hospital of Kunming Medical University, 5Department of Psychiatry, The Sixth People’s Hospital of Hebei Province, 6Department of Medical Affairs, Xi’an Janssen Pharmaceutical Ltd., Beijing, People’s Republic of China *These authors contributed equally to this work Rationale: Long-acting injectable (LAI paliperidone palmitate 1-month formulation (PP1M has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest.Objective: The aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia.Methods: In this 25-week, open-label, Phase IV study, patients (18–65 years diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS total score of 60–120 (inclusive were enrolled. All patients received injections of PP1M 150 mg eq. (day 1 and 100 mg eq. (day 8, followed by a flexible once-monthly maintenance dosing (75, 100, or 150 mg eq..Results: Of the 353 patients, 234 (66.3% completed the study treatment (mean age, 31.1 years; 52.7% men. The PANSS total score (primary end point improved significantly over the 6-month treatment period (mean [standard deviation] change from baseline to end of treatment, -27.2 [18.30]; P<0.0001. The Clinical Global Impressions-Severity and Personal and Social Performance scores (secondary end points also improved

  7. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function

    DEFF Research Database (Denmark)

    Kielgast, Urd; Krarup, Thure; Holst, Jens Juul

    2011-01-01

    OBJECTIVE To investigate the effect of 4 weeks of treatment with liraglutide on insulin dose and glycemic control in type 1 diabetic patients with and without residual ß-cell function. RESEARCH DESIGN AND METHODS Ten type 1 diabetic patients with residual ß-cell function (C-peptide positive) and 19.......1]; P Treatment with liraglutide in type 1 diabetic patients reduces insulin dose with improved or unaltered glycemic control....... activity was performed before (week 0) and during (week 4) treatment. Differences in insulin dose; HbA(1c); time spent with blood glucose 10, and 3.9-9.9 mmol/L; and body weight were evaluated. RESULTS Insulin dose decreased from 0.50 ± 0.06 to 0.31 ± 0.08 units/kg per day (P

  8. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia

    DEFF Research Database (Denmark)

    Stender, Steen; Budinski, Dragos; Gosho, Masahiko

    2013-01-01

    randomized to six treatment groups (1, 2, or 4 mg pitavastatin vs. 10, 20, or 40 mg pravastatin) in a 12-week multicentre double-blind study. Patients (n = 942; men, 44.3%; Caucasian, 99.3%; mean age, 70 years; age range, 65-89 years) in all groups were well matched for duration of disease and diagnosis......Aim: To compare the safety and efficacy of once-daily pitavastatin (1, 2, and 4 mg) and pravastatin (10, 20, and 40 mg) in elderly patients (≥65 years of age) with primary hypercholesterolaemia or combined (mixed) dyslipidaemia.Design: After a 6-8-week washout/dietary period, patients were.......Results: Mean decreases in low-density lipoprotein cholesterol over 12 weeks were 31.4-44.3% with pitavastatin 1-4 mg and 22.4-34.0% with pravastatin 10-40 mg (p

  9. Long-term outcome of lobar ablation in differentiated thyroid cancer (DTC): a comparative study with patients of completion thyroidectomy

    International Nuclear Information System (INIS)

    Santra, Amburanjan; Maharjan, S.; Bal, C.

    2010-01-01

    Full text: Completion thyroidectomy (CT) is usually recommended after partial surgery in patients with differentiated thyroid cancer. Radioiodine lobar ablation (RAILA) is an easy alternative and avoids complications that might be associated with re-surgery. But its effectiveness in terms of long-term outcome and recurrence free survival is yet to be established. This study was aimed to compare long term outcome of RAILA with that of completion thyroidectomy. Materials and Methods: A retrospective analysis was done from the case records of patients treated in our thyroid clinic for last 25 years. Records of all patients of RAILA (364) and CT (372) were analyzed. Complete ablation rate, cumulative dose needed for complete ablation, Recurrence rate and recurrence free survival was estimated in each group. Comparison was made between two groups by statistical method. Results: There was 73% ablation rate at 1st dose of RAILA itself. Second dose in LA and first dose of remnant ablation after CT is comparable (92% and 93% respectively). Cumulative dose to achieve 100% ablation rate is more for RAILA group. Seven patients developed recurrence in RAILA group, compared to 14 in CT group. No statistically significant difference was noted between recurrence rate and recurrence free survival between two groups. Conclusion: Radioiodine Lobar ablation is a safe, effective and less costly alternative to completion thyroidectomy in patients with differentiated thyroid cancer with comparable long term outcome like recurrence rate and recurrence free survival

  10. Effects and safety of allogenic mesenchymal stem cell intravenous infusion in active ankylosing spondylitis patients who failed NSAIDs: a 20-week clinical trial.

    Science.gov (United States)

    Wang, Peng; Li, Yuxi; Huang, Lin; Yang, Jiewen; Yang, Rui; Deng, Wen; Liang, Biling; Dai, Lie; Meng, Qingqi; Gao, Liangbin; Chen, Xiaodong; Shen, Jun; Tang, Yong; Zhang, Xin; Hou, Jingyi; Ye, Jichao; Chen, Keng; Cai, Zhaopeng; Wu, Yanfeng; Shen, Huiyong

    2014-01-01

    Our objective was to evaluate the feasibility, safety, and efficacy of intravenous (IV) infusion of allogenic mesenchymal stem cells (MSCs) in ankylosing spondylitis (AS) patients who are refractory to or cannot tolerate the side effects of nonsteroidal anti-inflammatory drugs (NSAIDs). AS patients enrolled in this study received four IV infusions of MSCs on days 0, 7, 14, and 21. The percentage of ASAS20 responders (the primary endpoint) at the fourth week and the mean ASAS20 response duration (the secondary endpoint) were used to assess treatment response to MSC infusion and duration of the therapeutic effects. Ankylosing Spondylitis Disease Activity Score Containing C-reactive Protein (ASDAS-CRP) and other preestablished evaluation indices were also adopted to evaluate the clinical effects. Magnetic resonance imaging (MRI) was performed to detect changes of bone marrow edema in the spine. The safety of this treatment was also evaluated. Thirty-one patients were included, and the percentage of ASAS20 responders reached 77.4% at the fourth week, and the mean ASAS20 response duration was 7.1 weeks. The mean ASDAS-CRP score decreased from 3.6 ± 0.6 to 2.4 ± 0.5 at the fourth week and then increased to 3.2 ± 0.8 at the 20th week. The average total inflammation extent (TIE) detected by MRI decreased from 533,482.5 at baseline to 480,692.3 at the fourth week (p > 0.05) and 400,547.2 at the 20th week (p < 0.05). No adverse effects were noted. IV infusion of MSCs is a feasible, safe, and promising treatment for patients with AS.

  11. Adjunctive α-lipoic acid reduces weight gain compared with placebo at 12 weeks in schizophrenic patients treated with atypical antipsychotics: a double-blind randomized placebo-controlled study.

    Science.gov (United States)

    Kim, Nam Wook; Song, Yul-Mai; Kim, Eosu; Cho, Hyun-Sang; Cheon, Keun-Ah; Kim, Su Jin; Park, Jin Young

    2016-09-01

    α-Lipoic acid (ALA) has been reported to be effective in reducing body weight in rodents and obese patients. Our previous open trial showed that ALA may play a role in reducing weight gain in patients with schizophrenia on atypical antipsychotics. The present study evaluated the efficacy of ALA in reducing weight and BMI in patients with schizophrenia who had experienced significant weight gain since taking atypical antipsychotics. In a 12-week, double-blind randomized placebo-controlled study, 22 overweight and clinically stable patients with schizophrenia were randomly assigned to receive ALA or placebo. ALA was administered at 600-1800 mg, as tolerated. Weight, BMI, abdomen fat area measured by computed tomography, and metabolic values were determined. Adverse effects were also assessed to examine safety. Overall, 15 patients completed 12 weeks of treatment. There was significant weight loss and decreased visceral fat levels in the ALA group compared with the placebo group. There were no instances of psychopathologic aggravation or severe ALA-associated adverse effects. ALA was effective in reducing weight and abdominal obesity in patients with schizophrenia who had experienced significant weight gain since beginning an atypical antipsychotic regimen. Moreover, ALA was well tolerated throughout this study. ALA might play an important role as an adjunctive treatment in decreasing obesity in patients who take atypical antipsychotics.

  12. BCL-2, in combination with MVP and IGF-1R expression, improves prediction of clinical outcome in complete response cervical carcinoma patients treated by radiochemotherapy.

    Science.gov (United States)

    Henríquez-Hernández, Luis Alberto; Lloret, Marta; Pinar, Beatriz; Bordón, Elisa; Rey, Agustín; Lubrano, Amina; Lara, Pedro Carlos

    2011-09-01

    To investigate whether BCL-2 expression would improve MVP/IGF-1R prediction of clinical outcome in cervix carcinoma patients treated by radiochemotherapy, and suggest possible mechanisms behind this effect. Fifty consecutive patients, who achieved complete response to treatment, from a whole series of 60 cases suffering from non-metastatic localized cervical carcinoma, were prospectively included in this study from July 1999 to December 2003. Follow-up was closed in January 2011. All patients received pelvic radiation (45-64.80 Gy in 1.8-2 Gy fractions) with concomitant cisplatin at 40 mg/m2/week doses followed by brachytherapy. Oncoprotein expression was studied by immunohistochemistry in paraffin-embedded tumour tissue. No relation was found between BCL-2 and clinicopathological variables. High MVP/IGF-1R/BCL-2 tumour expression was strongly related to poor local and regional disease-free survival (PMVP, and IGF-1R overexpression were related to poorer clinical outcome in cervical cancer patients who achieved clinical complete response to radiochemotherapy. The NHEJ repair protein Ku70/80 expression could be involved in the regulation of these oncoproteins. Copyright © 2011 Elsevier Inc. All rights reserved.

  13. The predictive value of leucocyte progression for one-week mortality on acutely admitted medical patients to the emergency department

    DEFF Research Database (Denmark)

    Brabrand, Mikkel; Soltau, Matilde Røgilds

    2018-01-01

    female. Using logistic regression, we found significantly lower one-week mortality with falling leucocyte count progression, even when controlling for confounders. A decreasing leucocyte count had a sensitivity for one-week mortality of 65%, specificity of 62%, positive predictive value of 4......%, and negative predictive value of 99%. Difference in admission to the intensive care unit was non-significant between the three groups. Difference in length of stay was significant, but with one day difference, the clinical significance is questionable. CONCLUSION: Leucocyte count progression is not sensitive...... enough to predict one-week mortality, nor specific enough to discount it. It is important for physicians to be aware of this to avoid faulty assessments based on imprecise assumptions....

  14. Endobronchial valves in severe emphysematous patients: CT evaluation of lung fissures completeness, treatment radiological response and quantitative emphysema analysis

    Energy Technology Data Exchange (ETDEWEB)

    Koenigkam-Santos, Marcel, E-mail: marcelk46@yahoo.com.br, E-mail: marcelk46@usp.b [Universidade de Sao Paulo (HCFMRP/USP), Ribeirao Preto, SP (Brazil). Hospital das Clinicas da Faculdade de Medicina; Paula, Wagner Diniz de [University of Brasilia (UnB), DF (Brazil). Brasilia University Hospital; Gompelmann, Daniela [University of Heidelberg (Germany). Department of Pneumology and Respiratory Medicine of the Chest Clinic (Thoraxklinik); Kauczor, Hans-Ulrich [University of Heidelberg (Germany). Department of Diagnostic and Interventional Radiology; Heussel, Claus Peter; Puderbach, Michael [University of Heidelberg (Germany). Department of Diagnostic and Interventional Radiology with Nuclear Medicine of the Chest Clinic (Thoraxklinik)

    2013-01-15

    Objective: To evaluate lung fissures completeness, post-treatment radiological response and quantitative CT analysis (QCTA) in a population of severe emphysematous patients submitted to endobronchial valves (EBV) implantation. Materials and Methods: Multi-detectors CT exams of 29 patients were studied, using thin-section low dose protocol without contrast. Two radiologists retrospectively reviewed all images in consensus; fissures completeness was estimated in 5% increments and post-EBV radiological response (target lobe atelectasis/volume loss) was evaluated. QCTA was performed in pre and post-treatment scans using a fully automated software. Results: CT response was present in 16/29 patients. In the negative CT response group, all 13 patients presented incomplete fissures, and mean oblique fissures completeness was 72.8%, against 88.3% in the other group. QCTA most significant results showed a reduced post-treatment total lung volume (LV) (mean 542 ml), reduced EBV-submitted LV (700 ml) and reduced emphysema volume (331.4 ml) in the positive response group, which also showed improved functional tests. Conclusion: EBV benefit is most likely in patients who have complete interlobar fissures and develop lobar atelectasis. In patients with no radiological response we observed a higher prevalence of incomplete fissures and a greater degree of incompleteness. The fully automated QCTA detected the post-treatment alterations, especially in the treated lung analysis. (author)

  15. In long-term bedridden elderly patients with dietary copper deficiency, biochemical markers of bone resorption are increased with copper supplementation during 12 weeks.

    Science.gov (United States)

    Kawada, Etsuo; Moridaira, Kazuaki; Itoh, Katsuhiko; Hoshino, Ayami; Tamura, Jun'ichi; Morita, Toyoho

    2006-01-01

    Although the effect of copper on bone has been tested in animals and healthy subjects, no studies concerning the effect of copper supplementation on bone metabolism in patients with copper deficiency have been reported because of the rarity of these patients. This study was conducted to investigate the effect of copper supplementation on bone metabolism in copper-deficient patients. This study included 10 patients (83.7 +/- 8.3 years) with dietary copper deficiency under long-term bed rest for more than 12 months. They had their diets supplemented with copper sulfate (3 mg/day) over 12 weeks in addition to their diet of only one kind of enteral food with a low concentration of copper. Serum copper and ceruloplasmin, urinary deoxypyridinoline (DPD) and collagen-type 1 N-telopeptide (NTX) (biomarkers of bone resorption), serum osteocalcin (OC) and bone-specific alkaline phosphatase (Bone ALP) (biomarkers of bone formation) were analyzed at baseline, 4 and 12 weeks after copper supplementation. DPD and NTX excretion were significantly increased 4 weeks after copper supplementation (p = 0.009 and p = 0.013, respectively). Serum bone ALP and OC were not significantly changed 12 weeks after copper supplementation (p = 0.051 and p = 0.594). In patients with nutritional copper deficiency, bone resorption markers are increased with copper supplementation. Copyright (c) 2006 S. Karger AG, Basel.

  16. Weekly monitoring of the effects of conventional external beam radiation therapy on patients with head and neck, chest, and pelvis cancer by means of blood cells count

    Energy Technology Data Exchange (ETDEWEB)

    Lundgren, Maria da Salete Fonseca dos Santos [Hospital Universitario Oswaldo Cruz, Recife, PE (Brazil). Radiotherapy Unit]. E-mail: salete@lundgren.med.br; Cavalcanti, Maria do Socorro de Mendonca [Universidade de Pernambuco, Recife, PE (Brazil); Sampaio, Divaldo de Almeida [Centro de Hematologia de Pernambuco (Hemope), Recife, PE (Brazil)

    2008-01-15

    Objective: To evaluate the necessity of weekly monitoring by means of leukocyte and platelet counts of patients with head and neck, chest, and pelvis cancer submitted to conventional radiotherapy. Materials and methods: A hundred and one adult patients with cancer of head and neck (n = 11), chest (n = 35) and pelvis (n = 55), submitted to radiotherapy were assessed by means of leukocyte and platelet counts on a weekly basis, with a comparison between the results before and during the treatment and in correlation with the area treated, patient's sex and age group. Results: The most significant decrease in leukocytes was observed in the fourth week, when lymphocytes, total leukocytes, neutrophils, monocytes and platelets presented a decrease of 53.5%, 26.8%, 19.4%, 22.2% and 14.6%, respectively, in comparison with the values found before the beginning of the therapy. Geometric means for pelvis during the treatment were lower than those for chest, and head and neck. Lymphocytes demonstrated to be more sensitive to radiation therapy. No alteration was found in leukocyte or platelet counts in correlation with patients' sex or age. Conclusion: Based on the results of the present study, weekly leukocyte and platelet counts do not seem to be useful in the assessment patients submitted to conventional radiotherapy for localized cancer. (author)

  17. Prognosis of critical limb ischemia patients with tissue loss after achievement of complete wound healing by endovascular therapy.

    Science.gov (United States)

    Kobayashi, Norihiro; Hirano, Keisuke; Nakano, Masatsugu; Ito, Yoshiaki; Ishimori, Hiroshi; Yamawaki, Masahiro; Tsukahara, Reiko; Muramatsu, Toshiya

    2015-04-01

    Critical limb ischemia (CLI) patients with tissue loss have been recognized to have a poor survival rate. In this study, we aimed to determine whether the prognosis of CLI patients with tissue loss improves after complete wound healing is achieved by endovascular therapy. We treated 187 CLI patients with tissue loss by endovascular therapy from April 2007 to December 2012. Among these patients, 113 patients who achieved complete wound healing were enrolled. The primary end point was survival rate at 3 years. The secondary end points were limb salvage rate and recurrence rate of CLI at 3 years. The mean follow-up period after achievement of complete wound healing was 32 ± 18 months. At 1 year, 2 years, and 3 years, the survival rates were 86%, 79%, and 74%; the limb salvage rates were 100%, 100%, and 100%; the recurrence rates of CLI were 2%, 6%, and 9%, respectively. On multivariate Cox proportional hazard analysis, age >75 years (hazard ratio, 3.18; 95% confidence interval, 1.23-8.24; P = .017) and nonambulatory status (hazard ratio, 2.46; 95% confidence interval, 1.08-5.65; P = .035) were identified as independent predictors of death for CLI patients with tissue loss even after complete wound healing was achieved. The Kaplan-Meier curve for the overall survival rate at 3 years showed that CLI patients of older age (>75 years) had a significantly decreased survival rate compared with CLI patients of younger age (≤75 years) (58% vs 87%; log-rank test, P wound healing was achieved. Nonambulatory status and age >75 years can serve as predictors of death even after complete wound healing is achieved. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

  18. The Nordic back pain subpopulation program: course patterns established through weekly follow-ups in patients treated for low back pain

    Directory of Open Access Journals (Sweden)

    Leboeuf-Yde Charlotte

    2010-01-01

    Full Text Available Abstract Background Low back pain (LBP is known to have a fluctuating course. In clinical studies, when deciding on duration of treatment and time for follow-up, it is important to know at what point in time a definite pattern of recovery becomes apparent and at what time a possible recurrence is likely to occur. A detailed description of the pain pattern has been difficult to establish with commonly used methods for follow-up, and we now introduce data collection by means of text messaging on mobile phones. The purpose of this study was to describe the detailed course of LBP during 18 weeks in a population treated in the primary care sector by chiropractors. Methods The study population consisted of 78 patients presenting to a chiropractor with LBP, who for at least 12 weeks responded to the questions sent by text messaging concerning 1 the number of LBP-days the preceding week and 2 the intensity of present LBP. Results A rapid improvement was observed through weeks one to four. After week seven no further improvement happened, and from the 12th week there seemed to be a tendency towards worsening. Conclusions We suggest that follow-ups in studies concerning primary sector LBP care are conducted in week seven after treatment was initiated and at some later point which cannot be established from this study. In clinical practice we recommend that patients' LBP status is systematically followed for the first four weeks since lack of improvement during that period should cause watchfulness.

  19. Complete elimination of cardiodepressant IgG3 autoantibodies by immunoadsorption in patients with severe heart failure

    International Nuclear Information System (INIS)

    Baba, Akiyasu; Akaishi, Makoto; Shimada, Megumi; Wakabayashi, Yasuhisa; Takahashi, Michiko; Monkawa, Toshiaki; Nagatomo, Yuji; Yoshikawa, Tsutomu

    2010-01-01

    Cardiodepressant IgG3 autoantibodies (CD-Abs) can be targeted by apheresis. Using blinded measurements of CD-Abs before and after immunoadsorption (IA), the cardiac function of patients who did or did not achieve complete CD-Abs elimination was compared. Autoantibodies were completely removed from 18 patients with heart failure (New York Heart Association class 3 or 4, left ventricular ejection fraction (LVEF) <30%) using a selective IgG3 adsorption column. All patients had anti-β1-adrenergic and/or M2-muscarinic autoantibodies before IA, and all LVEF were measured on radionuclide ventriculography. CD-Abs were measured before and after IA, and patient status was blinded until all measurements were collected. Treatment was defined as complete when CD-Abs status changed from positive to negative after IA. Other instances were defined as incomplete. Six-min walk test results and brain natriuretic peptide levels improved significantly after IA (P<0.01). The increase in LVEF 3 months after IA was significantly greater after complete treatment in comparison to the incomplete treatment group (19±8-29±9% vs 18±9-17±8%, P<0.01). Cardiac insufficiency events were also more frequent in the incomplete treatment group. Complete elimination of CD-Abs with apheresis may be related to improved cardiac function in the treatment of heart failure. (author)

  20. Evaluation of posterior lateral femoral condylar hypoplasia using axial MRI images in patients with complete discoid meniscus.

    Science.gov (United States)

    Xu, Zhihong; Chen, Dongyang; Shi, Dongquan; Dai, Jin; Yao, Yao; Jiang, Qing

    2016-03-01

    Hypoplasia of the lateral femoral condyle has been reported in discoid lateral meniscus patients, but associated imaging findings in the axial plane have not been characterized. In this study, we aimed to identify differences in the lateral femoral condyle between patients with discoid lateral meniscus and those with normal menisci using axial MRI images. Twenty-three patients (24 knees) with complete discoid lateral meniscus, 43 (45 knees) with incomplete discoid lateral meniscus, and 50 with normal menisci (50 knees) were enrolled and distributed into three groups. Two new angles, posterior lateral condylar angle (PLCA) and posterior medial condylar angle (PMCA), were measured on axial MRI images; the posterior condylar angle (PCA) was also measured. Differences between the three groups in the PLCA, PMCA, PCA, and PLCA/PMCA were analysed. The predictive value of PLCA and PLCA/PMCA for complete discoid lateral meniscus was assessed. In the complete discoid lateral meniscus group, PLCA and PLCA/PMCA were significantly smaller compared with the normal meniscus group and the incomplete discoid lateral meniscus group (P meniscus group compared with the incomplete discoid lateral meniscus group (P meniscus group (P meniscus. Hypoplasia of the posterior lateral femoral condyle is typically seen in patients with complete discoid lateral meniscus. PLCA and PLCA/PMCA can be measured from axial MRI images and used as excellent predictive parameters for complete discoid lateral meniscus. Diagnostic study, Level III.

  1. Four weeks of paritaprevir/ritonavir/ombitasvir plus dasabuvir encountering dengue fever resulted in sustained virological response in an HCV patient: A case report.

    Science.gov (United States)

    Huang, Chung-Feng; Jang, Tyng-Yuan; Lu, Po-Liang; Yu, Ming-Lung

    2016-11-01

    Direct antiviral agent (DAA) has been the standard of care for patients with hepatitis C virus (HCV) infection. Twelve weeks of paritaprevir/ritonavir/ombitasvir plus dasabuvir (PROD) with or without ribavirin has shown to have a sustained virological response at post-treatment 12 weeks (SVR12) rate of >90% in HCV genotype 1 (HCV-1) patients. We report a HCV-1b patient who received only 25 days of PROD treatment. The patient early terminated treatment due to dengue fever but eventually achieved SVR12. It may attribute to low baseline viral loads and extraordinarily rapid suppression of HCV after treatment day1. The finding may shed light for possible response-guided-therapy for so-called ultra-super-responders in the DAA era. Whether the dengue virus, the Flaviviridae family as with HCV, enhanced the HCV clearance remains unclear and needs further exploration.

  2. Clinical Outcome of Patients with Complete Pathological Response to Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancers: The Indian Scenario

    Directory of Open Access Journals (Sweden)

    Snita Sinukumar

    2014-01-01

    Full Text Available Introduction. Neoadjuvant chemoradiotherapy and total mesorectal excision are considered the standard treatment for locally advanced rectal cancer. Various studies have reported pathological downstaging and a complete pathological response rate of 15%–27% following neoadjuvant chemoradiotherapy which has translated into improved survival. We endeavour to determine the clinical outcome of patients attaining a complete pathological tumor response following neoadjuvant chemoradiotherapy in the Indian setting where most of our patient population is younger and presents with aggressive tumor biology. Materials and Methods. Clinicopathological and treatment details were recorded for 64 patients achieving pathological complete response from 2010 to 2013. Disease-free survival (DFS, overall survival (OS, and locoregional and systemic recurrence rates were evaluated for these patients. Results. After a median follow-up of 30.5 months (range 11–59 months, the 3-year overall survival (OS was 94.6% and the 3-year disease-free survival (DFS was 88.5%. The locoregional and systemic recurrence rates were 4.7% and 3.1%, respectively. Conclusion. In the Indian subcontinent, despite younger patients with aggressive tumor biology, outcome in complete responders is good.

  3. Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study.

    Science.gov (United States)

    Olde Rikkert, Marcel G M; Verhey, Frans R; Blesa, Rafael; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Sijben, John; Scarpini, Elio; Vandewoude, Maurits F J; Vellas, Bruno; Witkamp, Renger; Kamphuis, Patrick J G H; Scheltens, Philip

    2015-01-01

    The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD patients using AD medication. Souvenaid was well-tolerated in all RCTs. In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.

  4. Tolerability and Safety of Souvenaid in Patients with Mild Alzheimer's Disease: Results of Multi-Center, 24-Week, Open-Label Extension Study

    NARCIS (Netherlands)

    Rikkert, M.G.M.O.; Verhey, F.R.J.; Blesa, R.; von Arnim, C.A.F.; Bongers, A.; Harrison, J.; Sijben, J.; Scarpini, E.; Vandewoude, M.F.J.; Vellas, B.; Witkamp, R.; Kamphuis, P.J.G.H.; Scheltens, P.

    2015-01-01

    Background: The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration

  5. Tolerability and safety of souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study

    NARCIS (Netherlands)

    Olde Rikkert, M.G.M.; Verhey, F.R.J.; Blesa, R.; Arnim, C.A. von; Bongers, A.; Harrison, J.; Sijben, J.; Scarpini, E.; Vandewoude, M.F.; Vellas, B.; Witkamp, R.; Kamphuis, P.J.; Scheltens, P.

    2015-01-01

    BACKGROUND: The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration

  6. The dangerous gamble of heparinization within two weeks of nonoperative traumatic acute subdural hematoma in patients with increased stroke risk: a case series.

    Science.gov (United States)

    McClelland, S; Mackey, S J; Kim, S S

    2014-01-01

    In traumatic acute subdural hematoma (aSDH) management, systemic anticoagulation is contraindicated, particularly during the first 2 weeks. We present two cases of patients with nonoperative aSDH whose stroke risk led to heparinization within 2 weeks of the initial hemorrhage and examine their outcomes to illustrate the risks and benefits associated with systemic anticoagulation. Two elderly males, on warfarin at baseline who developed traumatic nonoperative aSDH were heparinized within 2 weeks of aSDH onset. One patient showed a decreased SDH volume on Day 19. The second patient developed sudden onset headache with fixed/dilated pupils on Day 5. In this patient, a CT scan of the brain revealed marked enlargement of the aSDH from 0.9 to 2.4 cm with midline shift of 1.5 cm, and uncal herniation that was incompatible with life. Heparinization within two weeks of aSDH may cause SDH enlargement resulting in rapidly fatal neurologic deterioration. Further study is needed to more definitively address this issue.

  7. Pegylated Long-Acting Human Growth Hormone Possesses a Promising Once-Weekly Treatment Profile, and Multiple Dosing Is Well Tolerated in Adult Patients with Growth Hormone Deficiency

    DEFF Research Database (Denmark)

    Søndergaard, Esben; Klose, Marianne; Hansen, Mette

    2011-01-01

    Background: Recombinant human GH (rhGH) replacement therapy in children and adults currently requires daily sc injections for several years or lifelong, which may be both inconvenient and distressing for patients. NNC126-0083 is a pegylated rhGH developed for once-weekly administration. Objectives...

  8. Effects of glucose and insulin levels on adipose tissue glucose measurement by microdialysis probes retained for three weeks in Type 1 diabetic patients

    NARCIS (Netherlands)

    Hullegie, LM; Lutgers, HL; Dullaart, RPF; Sluiter, WJ; Wientjes, KJ; Schoonen, AJM; Hoogenberg, K

    Background: To evaluate the effects of acute hyperglycaemia and hyperinsulinaemia on adipose tissue glucose measurements by microdialysis probes inserted for a 3-week period. Methods: Microdialysis probes were implanted pairwise in abdominal adipose tissue in seven Type 1 diabetic patients and

  9. Multimodality treatment including postoperative radiation and concurrent chemotherapy with weekly docetaxel is feasible and effective in patients with oral and oropharyngeal cancer

    International Nuclear Information System (INIS)

    Kovacs, A.F.; Bitter, K.; Mose, S.; Boettcher, H.D.

    2005-01-01

    Background: to examine the feasibility and efficacy of weekly docetaxel with concurrent radiation as postoperative treatment in a multimodality approach to oral and oropharyngeal cancer. Patients and methods: 94 patients (Table 1) with primary resectable squamous cell carcinoma of the oral cavity and oropharynx (UICC stage I 14%, II 15%, III 18%, IV 53%; Table 2) were treated with a multimodality therapy program consisting of neoadjuvant intra-arterial high-dose chemotherapy (cisplatin 150 mg/m 2 with parallel systemic sodium thiosulfate 9 g/m 2 for neutralization), followed by surgery of the primary and neck, and postoperative concurrent radiation and chemotherapy with weekly docetaxel (20-30 mg/m 2 ; Table 3). Chronic toxicities were followed over a period of 5 years. Results: at a median follow-up of 4 years, the 5-year survival rate for all 94 patients was 80%, and disease-free survival was 73% (Figures 1 and 2). Among patients with advanced disease (stage III and IV), survival was 83 and 59%, respectively (Figure 4). Grade 3 and 4 mucositis was the main acute toxicity necessitating supportive care. Long-term toxicity appears to be moderate (Table 4). The maximum tolerated dose of weekly docetaxel was 25 mg/m 2 . Conclusions: concurrent radiation and chemotherapy with weekly docetaxel is a feasible postoperative treatment in a multimodality approach to oral and oropharyngeal cancer, resulting in high overall and disease-free survival. This approach warrants further evaluation in prospective randomized trials. (orig.)

  10. Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response

    DEFF Research Database (Denmark)

    Dalgard, Olav; Bjøro, Kristian; Larsen, Helmer Ring

    2008-01-01

    A recent nonrandomized pilot trial showed that hepatitis C virus (HCV) patients with genotype 2/3 and rapid virological response (RVR) had a 90% sustained virological response (SVR) rate after 14 weeks of treatment. We aimed to assess this concept in a randomized controlled trial. In the trial, 428...

  11. Clinical comparison of masticatory performance and electromyographic activity of patients with complete dentures, overdentures, and natural teeth.

    Science.gov (United States)

    Rissin, L; House, J E; Manly, R S; Kapur, K K

    1978-05-01

    In this study, which is the first of its kind, it has been shown that overdenture patients, when compared to complete denture patients, while chewing a test food for a constant number of strokes, expended an equivalent amount of muscle effort, chewed more slowly and efficiently, and evidenced significantly better masticatory performance by producing an increased volume of fine test food particles. These findings provide a sound justification for the extra effort required to retain some natural teeth to provide overdenture services to patients. The fact that patients can masticate food more efficiently with overdentures than with complete dentures justifies the increased cost and time involved in their construction. The longitudinal effects that overdentures have on the basic physiopathologic processed involved in the progression of ridge resorption and the advantages of maintaining periodontal proprioception also should be studied.

  12. The Danish Registry on Regular Dialysis and Transplantation:completeness and validity of incident patient registration

    DEFF Research Database (Denmark)

    Hommel, Kristine; Rasmussen, Søren; Madsen, Mette

    2010-01-01

    BACKGROUND: The Danish National Registry on Regular Dialysis and Transplantation (NRDT) provides systematic information on the epidemiology and treatment of end-stage chronic kidney disease in Denmark. It is therefore of major importance that the registry is valid and complete. The aim of the pre...

  13. Early perfusion changes within 1 week of systemic treatment measured by dynamic contrast-enhanced MRI may predict survival in patients with advanced hepatocellular carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Bang-Bin; Yu, Chih-Wei; Liang, Po-Chin [National Taiwan University College of Medicine and Hospital, Department of Medical Imaging and Radiology, Taipei City (China); Hsu, Chao-Yu [National Taiwan University College of Medicine and Hospital, Department of Medical Imaging and Radiology, Taipei City (China); Taipei Hospital, Ministry of Health and Welfare, Department of Radiology, New Taipei City (China); Hsu, Chiun; Hsu, Chih-Hung; Cheng, Ann-Lii [National Taiwan University College of Medicine and Hospital, Department of Oncology, Taipei City (China); Shih, Tiffany Ting-Fang [National Taiwan University College of Medicine and Hospital, Department of Medical Imaging and Radiology, Taipei City (China); Taipei City Hospital, Department of Medical Imaging, Taipei City (China); National Taiwan University Hospital, Department of Medical Imaging, Taipei (China)

    2017-07-15

    To correlate early changes in the parameters of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) within 1 week of systemic therapy with overall survival (OS) in patients with advanced hepatocellular carcinoma (HCC). Eighty-nine patients with advanced HCC underwent DCE-MRI before and within 1 week following systemic therapy. The relative changes of six DCE-MRI parameters (Peak, Slope, AUC, Ktrans, Kep and Ve) of the tumours were correlated with OS using the Kaplan-Meier model and the double-sided log-rank test. All patients died and the median survival was 174 days. Among the six DCE-MRI parameters, reductions in Peak, AUC, and Ktrans, were significantly correlated with one another. In addition, patients with a high Peak reduction following treatment had longer OS (P = 0.023) compared with those with a low Peak reduction. In multivariate analysis, a high Peak reduction was an independent favourable prognostic factor in all patients [hazard ratio (HR), 0.622; P = 0.038] after controlling for age, sex, treatment methods, tumour size and stage, and Eastern Cooperative Oncology Group performance status. Early perfusion changes within 1 week following systemic therapy measured by DCE-MRI may aid in the prediction of the clinical outcome in patients with advanced HCC. (orig.)

  14. A technique to stabilize record bases for Gothic arch tracings in patients with implant-retained complete dentures.

    Science.gov (United States)

    Raigrodski, A J; Sadan, A; Carruth, P L

    1998-12-01

    Clinicians have long expressed concern about the accuracy of the Gothic arch tracing for recording centric relation in edentulous patients. With the use of dental implants to assist in retaining complete dentures, the problem of inaccurate recordings, made for patients without natural teeth, can be significantly reduced. This article presents a technique that uses healing abutments to stabilize the record bases so that an accurate Gothic arch tracing can be made.

  15. A mandibular implant-supported fixed complete dental prosthesis in a patient with Sjogren syndrome: case report.

    Science.gov (United States)

    Spinato, Sergio; Soardi, Carlo Maria; Zane, Anna Maria

    2010-06-01

    The article describes the treatment and 1 year follow-up of a patient with Sjogren syndrome, treated with 6 intraforaminal mandibular implants with delayed loading and an implant-retained fixed prosthesis. The maxillary arch has been treated with a complete denture. This made an enormous difference in comfort and function for the patient. Radiographic check-ups did not reveal any peri-implant bone loss after 1 year of loading.

  16. Development of a Prognostic Score Using the Complete Blood Cell Count for Survival Prediction in Unselected Critically Ill Patients

    OpenAIRE

    Chongliang, Fang; Yuzhong, Li; Qian, Shi; Xiliang, Liu; Hui, Liu

    2013-01-01

    Objective. The purpose of this study was to develop a new prognostic scoring system for critically ill patients using the simple complete blood cell count (CBC). Methods. CBC measurements in samples from 306 patients in an intensive care unit were conducted with automated analyzers, including levels of neutrophils, lymphocytes, erythrocytes, hemoglobin, and platelets. The time of sampling and the time of death were recorded. Z values were calculated according to the measured values, reference...

  17. Absence of MxA induction by interferon beta in patients with MS reflects complete loss of bioactivity

    DEFF Research Database (Denmark)

    Hesse, D.; Sellebjerg, F.; Sorensen, P.S.

    2009-01-01

    BACKGROUND: In patients with multiple sclerosis (MS), neutralizing antibodies (NAbs) appearing during treatment with interferon (IFN) beta reduce or in high concentrations abolish bioactivity and therapeutic efficacy. In vivo MxA induction by IFNbeta is used as a marker of biologic response....... Lack of MxA in vivo response in patients with multiple sclerosis with NAbs is a reliable marker of a completely blocked biologic response to IFNbeta, with no indication of residual bioactivity Udgivelsesdato: 2009/8/4...

  18. Arthritis patients show long-term benefits from 3 weeks intensive exercise training directly following hospital discharge

    NARCIS (Netherlands)

    Bulthuis, Y.; Drossaers-Bakker, K.W.; Drossaers-Bakker, K.W.; Taal, Erik; Rasker, Johannes J.; Oostveen, J.; van 't Pad Bosch, P.; Oosterveld, F.; van de Laar, Mart A F J

    2007-01-01

    Objective: To examine the efficacy of short-term intensive exercise training (IET) directly following hospital discharge. - Methods: In the Disabled Arthritis Patients Post-hospitalization Intensive Exercise Rehabilitation (DAPPER) study, patients with rheumatoid arthritis or osteoarthritis were

  19. Body attitudes in patients with eating disorders at presentation and completion of intensive outpatient day treatment.

    NARCIS (Netherlands)

    Exterkate, C.C.; Vriesendorp, P.F.; Jong, C.A.J. de

    2009-01-01

    Due to the importance of the distorted body experience in eating disorder diagnosis and treatment, we wanted to explore body attitudes of patients with eating disorders before and after 5 months of intensive specialized outpatient day treatment. We assessed 193 patients diagnosed with Anorexia

  20. Completeness of retail pharmacy claims data: implications for pharmacoepidemiologic studies and pharmacy practice in elderly patients.

    Science.gov (United States)

    Polinski, Jennifer M; Schneeweiss, Sebastian; Levin, Raisa; Shrank, William H

    2009-09-01

    In the elderly (those aged >or=65 years), retail pharmacy claims are used to study drug use among the uninsured after drug policy changes, to prevent drug-drug interactions and duplication of therapy, and to guide medication therapy management. Claims include only prescriptions filled at 1 pharmacy location or within 1 pharmacy chain and do not include prescriptions filled at outside pharmacies, potentially limiting research accuracy and pharmacy-based safety interventions. The aims of this study were to assess elderly patients' pharmacy loyalty and to identify predictors of using multiple pharmacies. Patients enrolled in the Pharmaceutical Assistance Contract for the Elderly (PACE) pharmacy benefit program with corresponding Medicare claims in the state of Pennsylvania comprised the study cohort. Among patients with pharmacy claims from all pharmacies used in 2004-2005, a primary pharmacy was defined as the pharmacy where at least 50% of a patient's prescriptions were filled. The number of pharmacies/chains used and prescriptions filled in 2005 was calculated. Predictors of using multiple pharmacies in 2005 were age, female gender, white race, urban residency, comorbidities, number of distinct chemical drugs (unique medications) used, and number of prescriptions filled, which were all assessed in 2004. In total, pharmacy claims data from 182,116 patients (147,718 women [81.1%]; mean [SD] age, 78.8 [7.1] years; 168,175 white [92.3%]; 76,580 [42.1%] residing in an urban zip code area) were included. Of the 182,116 PACE patients in the study, a primary pharmacy was identified for 180,751 patients (99.3%). In 2005, patients filled an average of 59.3 prescriptions, with 57.0 prescriptions (96.1%) having been filled at the primary pharmacy. Compared with patients who used or=15 unique medications had a 2.66 times (95% CI, 2.53-2.80) greater likelihood of using multiple pharmacies in 2005. Patients aged >or=85 years were 1.07 times (95% CI, 1.04-1.11) as likely to use

  1. Effects of A One-week Fasting Therapy in Patients with Type-2 Diabetes Mellitus and Metabolic Syndrome - A Randomized Controlled Explorative Study.

    Science.gov (United States)

    Li, Chenying; Sadraie, Badri; Steckhan, Nico; Kessler, Christian; Stange, Rainer; Jeitler, Michael; Michalsen, Andreas

    2017-10-01

    There is increasing experimental evidence for beneficial effects of calorie restriction and intermittent fasting in type 2 diabetes mellitus (T2DM). In humans, prolonged fasting is established as a health-promoting complementary treatment in Europe and claimed to improve metabolism by a complex hormetic response. We aimed to investigate effects of a one-week fasting period compared to usual care in T2DM by means of a pilot trial. Patients with manifest T2DM medically treated with oral hypoglycemic agents and/or insulin were randomly assigned to a 7-day fasting program followed by dietary advice or to usual care and dietary advice only. Fasting was performed according to the method of Buchinger with a nutritional energy intake of 300kcal/day by liquids only and stepwise re-introduction of solid food thereafter. Outcomes were assessed baseline and after 4 months. Of 46 enrolled participants, 32 (n=16 each group) completed the trial and were included for final analyses. Fasting was well accepted, there were no serious adverse events. After 4 months mean weight decreased by 3.5 kg and 2.0 kg in the fasting vs. control group (p=0.03) paralleled by greater reduction of abdominal circumference (p=0.001). Fasting led to a significant decrease of systolic/diastolic blood pressure (p=0.01; p=0.003) and increased quality-of-life (p=0.04), while for HbA 1c , insulin and HOMA-index only non-significant improvements were observed. Results of this study suggest that prolonged fasting is feasible and might have beneficial clinical effects. The effectiveness of fasting should be proved in larger confirmatory trials that include intermittent fasting in follow-ups to enable more pronounced and long-term effects. © Georg Thieme Verlag KG Stuttgart · New York.

  2. Complete loss of insulin secretion capacity in type 1A diabetes patients during long-term follow up.

    Science.gov (United States)

    Uno, Sae; Imagawa, Akihisa; Kozawa, Junji; Fukui, Kenji; Iwahashi, Hiromi; Shimomura, Iichiro

    2017-10-16

    Patients with type 1 diabetes are classified into three subtypes in Japan: acute onset, fulminant and slowly progressive. Acute-onset type 1 diabetes would be equivalent to type 1A diabetes, the typical type 1 diabetes in Western countries. The insulin secretion capacity in Japanese patients with long-standing type 1A diabetes is unclear. The aim of the present study was to clarify the course of endogenous insulin secretion during long-term follow up and the factors associated with residual insulin secretion in patients with acute-onset type 1 diabetes (autoimmune). We retrospectively investigated endogenous insulin secretion capacity in 71 patients who fulfilled the diagnostic criteria for acute-onset type 1 diabetes (autoimmune) in Japan. To assess the residual insulin secretion capacity, we evaluated randomly measured C-peptide levels and the results of glucagon stimulation test in 71 patients. In the first year of disease, the child- and adolescent-onset patients had significantly more in residual insulin secretion than the adult-onset patients (34 patients in total). C-peptide levels declined more rapidly in patients whose age of onset was ≤18 years than in patients whose age of onset was ≥19 years. Endogenous insulin secretion capacity stimulated by glucagon was completely lost in almost all patients at >15 years after onset (61 patients in total). Most patients with acute-onset type 1 diabetes (autoimmune) completely lose their endogenous insulin secretion capacity during the disease duration in Japan. Age of onset might affect the course of insulin secretion. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  3. Time to surgery and pathologic complete response after neoadjuvant chemoradiation in rectal cancer: A population study on 2094 patients

    Directory of Open Access Journals (Sweden)

    Gabriella Macchia

    2017-06-01

    Results: Data on 2094 LARC patients treated between 1997 and 2016 were considered suitable for analysis. Overall, 578 patients had stage II while 1516 had stage III histological proven invasive rectal adenocarcinoma. A CRT schedule of one agent (N = 1585 or 2-drugs (N = 509 was administered. Overall, pCR was 22.3% (N = 468 patients. The proportion of patients achieving pCR with respect to time interval was, as follows: 12.6% (1st group, 23% (2nd group and 31.1% (3rd group (p 5040 cGy (p = 0.002 and longer interval (p 13 weeks from CRT to surgery improves the pathological response (pCR and pathologic partial response; pPR in comparison to historic data. Furthermore, radiotherapy dose >5040 cGy and two drugs chemotherapy correlated with pPR rate.

  4. Moderate Sustained Virologic Response Rates With 6-Week Combination Directly Acting Anti-Hepatitis C Virus Therapy in Patients With Advanced Liver Disease.

    Science.gov (United States)

    Kattakuzhy, Sarah; Wilson, Eleanor; Sidharthan, Sreetha; Sims, Zayani; McLaughlin, Mary; Price, Angie; Silk, Rachel; Gross, Chloe; Akoth, Elizabeth; McManus, Maryellen; Emmanuel, Benjamin; Shrivastava, Shikha; Tang, Lydia; Nelson, Amy; Teferi, Gebeyehu; Chavez, Jose; Lam, Brian; Mo, Hongmei; Osinusi, Anuoluwapo; Polis, Michael A; Masur, Henry; Kohli, Anita; Kottilil, Shyamasundaran

    2016-02-15

    Treatment of genotype 1 hepatitis C virus (HCV) infection with combination directly acting antivirals (DAA) for 8-24 weeks is associated with high rates of sustained virologic response (SVR). We previously demonstrated that adding a third DAA to ledipasvir and sofosbuvir (LDV/SOF) can result in high SVR rates in patients without cirrhosis. In this study, we investigated whether a similar regimen would yield equivalent rates of cure in patients with advanced liver fibrosis. Fifty patients were enrolled at the Clinical Research Center of the National Institutes of Health and associated healthcare centers. Enrollment and follow-up data from April 2014 to June 2015 are reported here. Eligible participants were aged ≥18 years, had chronic HCV genotype 1 infection (serum HCV RNA ≥2000 IU/mL), and stage 3-4 liver fibrosis. HCV RNA was measured using a reverse-transcription polymerase chain reaction assay. Of patients treated with LDV, SOF, and the NS3/4A protease inhibitor GS-9451 for 6 weeks, 76% (38 of 50; 95% confidence interval, 60%-85%) had SVR achieved 12 weeks after the end of treatment. There was no statistically significant difference in treatment efficacy between treatment-naive patients (72%, 18 of 25) and those with treatment experience (80%; 20 of 25) (P = .51). Overall, 11 patients (22%) experienced virologic relapse, and 1 (2%) was lost to follow-up at 4 weeks after treatment. No serious adverse events, discontinuations, or deaths were associated with this regimen. Adding a third DAA to LDV/SOF may result in a moderate SVR rate, lower than that observed in patients without cirrhosis. Significant liver fibrosis remains an impediment to achieving SVR with short-duration DAA therapy. CT01805882. Published by Oxford University Press for the Infectious Diseases Society of America 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  5. Body attitudes in patients with eating disorders at presentation and completion of intensive outpatient day treatment.

    Science.gov (United States)

    Exterkate, Cecile C; Vriesendorp, Patricia F; de Jong, Cor A J

    2009-01-01

    Due to the importance of the distorted body experience in eating disorder diagnosis and treatment, we wanted to explore body attitudes of patients with eating disorders before and after 5 months of intensive specialized outpatient day treatment. We assessed 193 patients diagnosed with Anorexia Nervosa (AN), Bulimia Nervosa (BN) and Eating Disorder Not Otherwise Specified (EDNOS) using the Body Attitude Test (BAT), Body Mass Index (BMI), Eating Disorder Evaluation Scale (EDES) and Symptom Checklist 90 (SCL-90). Eating disorder subtypes differed in BMI, total body attitudes and negative appreciation of body size at intake, but not at termination of treatment. Following treatment, all patient groups reported large improvements in eating disorder pathology and all but the AN-Restrictive (AN-R) group, reported large improvements in overall psychological functioning. The AN patients demonstrated significant improvement in BMI, however the Anorexia Nervosa purging (AN-P) and Anorexia Nervosa restrictive (AN-R) subtypes differed in their changes in body attitudes. AN-R patients indicated no significant improvement in body attitudes. AN-P patients improved in total body attitudes, except one subscale. Patients with Bulimia Nervosa non-purging (BN-NP) subtype, Bulimia Nervosa purging (BN-P) subtype and EDNOS demonstrated similar improvements in total body attitudes (BAT). Body attitudes provide important insights into differences between eating disorder diagnostic categories and their treatment responsiveness.

  6. Blocking of an intronic splicing silencer completely rescues IKBKAP exon 20 splicing in familial dysautonomia patient cells

    DEFF Research Database (Denmark)

    Bruun, Gitte H; Bang, Jeanne Mv; Christensen, Lise L

    2018-01-01

    designed splice switching oligonucleotides (SSO) that blocks the intronic hnRNP A1 binding site, and demonstrate that this completely rescues splicing of IKBKAP exon 20 in FD patient fibroblasts and increases the amounts of IKAP protein. We propose that this may be developed into a potential new specific...

  7. A nomogram for predicting pathological complete response in patients with human epidermal growth factor receptor 2 negative breast cancer

    International Nuclear Information System (INIS)

    Jin, Xi; Jiang, Yi-Zhou; Chen, Sheng; Yu, Ke-Da; Ma, Ding; Sun, Wei; Shao, Zhi-Min; Di, Gen-Hong

    2016-01-01

    The response to neoadjuvant chemotherapy has been proven to predict long-term clinical benefits for patients. Our research is to construct a nomogram to predict pathological complete response of human epidermal growth factor receptor 2 negative breast cancer patients. We enrolled 815 patients who received neoadjuvant chemotherapy from 2003 to 2015 and divided them into a training set and a validation set. Univariate logistic regression was performed to screen for predictors and construct the nomogram; multivariate logistic regression was performed to identify independent predictors. After performing the univariate logistic regression analysis in the training set, tumor size, hormone receptor status, regimens of neoadjuvant chemotherapy and cycles of neoadjuvant chemotherapy were the final predictors for the construction of the nomogram. The multivariate logistic regression analysis demonstrated that T4 status, hormone receptor status and receiving regimen of paclitaxel and carboplatin were independent predictors of pathological complete response. The area under the receiver operating characteristic curve of the training set and the validation set was 0.779 and 0.701, respectively. We constructed and validated a nomogram to predict pathological complete response in human epidermal growth factor receptor 2 negative breast cancer patients. We also identified tumor size, hormone receptor status and paclitaxel and carboplatin regimen as independent predictors of pathological complete response. The online version of this article (doi:10.1186/s12885-016-2652-z) contains supplementary material, which is available to authorized users

  8. Diagnostic accuracy of risk of malignancy index in predicting complete tumor removal at primary debulking surgery for ovarian cancer patients

    DEFF Research Database (Denmark)

    Fagö-Olsen, Carsten L; Håkansson, Fanny; Antonsen, Sofie L

    2013-01-01

    Ovarian cancer patients in whom complete tumor removal is impossible with primary debulking surgery (PDS) may benefit from neoadjuvant chemotherapy and interval debulking surgery. However, the task of performing a pre-operative evaluation of the feasibility of PDS is difficult. We aimed to invest...

  9. Bone Height Changes of the Mandibular Edentulous Ridge in Screw Retained Versus Telescopic Restorations for Completely Edentulous Patients

    Directory of Open Access Journals (Sweden)

    Eman Helal

    2017-01-01

    CONCLUSION: Up to the limitations of this study both treatment options the screw retained and telescopic overdenture can be used for rehabilitation of completely edentulous patients. These cases must be followed for a longer period to have a definite answer regarding their efficiency in the long run.

  10. Neurodynamic treatment did not improve pain and disability at two weeks in patients with chronic nerve-related leg pain: a randomised trial

    Directory of Open Access Journals (Sweden)

    Giovanni Ferreira

    2016-10-01

    Full Text Available Question: In people with nerve-related leg pain, does adding neurodynamic treatment to advice to remain active improve leg pain, disability, low back pain, function, global perceived effect and location of symptoms? Design: Randomised trial with concealed allocation and intention-to-treat analysis. Participants: Sixty participants with nerve-related leg pain recruited from the community. Interventions: The experimental group received four sessions of neurodynamic treatment. Both groups received advice to remain active. Outcome measures: Leg pain and low back pain (0, none, to 10, worst, Oswestry Disability Index (0, none, to 100, worst, Patient-Specific Functional Scale (0, unable to perform, to 30, able to perform, global perceived effect (–5 to 5 and location of symptoms were measured at 2 and 4 weeks after randomisation. Continuous outcomes were analysed by linear mixed models. Location of symptoms was assessed by relative risk (95% CI. Results: At 2 weeks, the experimental group did not have significantly greater improvement than the control group in leg pain (MD –1.1, 95% CI –2.3 to 0.1 or disability (MD –3.3, 95% CI –9.6 to 2.9. At 4 weeks, the experimental group experienced a significantly greater reduction in leg pain (MD –2.4, 95% CI –3.6 to –1.2 and low back pain (MD –1.5, 95% CI –2.8 to –0.2. The experimental group also improved significantly more in function at 2 weeks (MD 5.2, 95% CI 2.2 to 8.2 and 4 weeks (MD 4.7, 95% CI 1.7 to 7.8, as well as global perceived effect at 2 weeks (MD 2.5, 95% CI 1.6 to 3.5 and 4 weeks (MD 2.9, 95% CI 1.9 to 3.9. No significant between-group differences occurred in disability at 4 weeks and location of symptoms. Conclusion: Adding neurodynamic treatment to advice to remain active did not improve leg pain and disability at 2 weeks. Trial registration: NCT01954199. [Ferreira G, Stieven F, Araujo F, Wiebusch M, Rosa C, Plentz R, et al. (2016 Neurodynamic treatment did not improve

  11. Isolation and complete genome analysis of neurotropic dengue virus serotype 3 from the cerebrospinal fluid of an encephalitis patient.

    Directory of Open Access Journals (Sweden)

    Rama Dhenni

    2018-01-01

    Full Text Available Although neurological manifestations associated with dengue viruses (DENV infection have been reported, there is very limited information on the genetic characteristics of neurotropic DENV. Here we describe the isolation and complete genome analysis of DENV serotype 3 (DENV-3 from cerebrospinal fluid of an encephalitis paediatric patient in Jakarta, Indonesia. Next-generation sequencing was employed to deduce the complete genome of the neurotropic DENV-3 isolate. Based on complete genome analysis, two unique and nine uncommon amino acid changes in the protein coding region were observed in the virus. A phylogenetic tree and molecular clock analysis revealed that the neurotropic virus was a member of Sumatran-Javan clade of DENV-3 genotype I and shared a common ancestor with other isolates from Jakarta around 1998. This is the first report of neurotropic DENV-3 complete genome analysis, providing detailed information on the genetic characteristics of this virus.

  12. Evolution of substance use, neurological and psychiatric symptoms in schizophrenia and substance use disorder patients: a 12-week, pilot, case-control trial with quetiapine

    Directory of Open Access Journals (Sweden)

    Simon eZhornitsky

    2011-05-01

    Full Text Available Neurological and psychiatric symptoms are consequences of substance abuse in schizophrenia and non-schizophrenia patients. The present case-control study examined changes in substance abuse/dependence and neurological and psychiatric symptoms in substance abusers with (DD group, n=26 and without schizophrenia (SUD group, n=24 and in non-abusing schizophrenia patients (SCZ group, n=23 undergoing 12-week treatment with the atypical antipsychotic, quetiapine. Neurological and psychiatric symptoms were evaluated with the Positive and Negative Syndrome Scale, the Calgary Depression Scale for Schizophrenia, the Extrapyramidal Symptoms Rating Scale and the Barnes Akathisia Rating Scale. At endpoint, DD and SCZ patients were receiving significantly higher doses of quetiapine (mean = 554mg/d and 478mg/d, respectively, relative to SUD patients (mean = 150mg/d. We found that SUD patients showed greater improvement in weekly dollars spent on alcohol and drugs and SUD severity, compared to DD patients. At endpoint, there was no significant difference in dollars spent, but DD patients still had a higher mean SUD severity. Interestingly, DD patients had significantly higher Parkinsonism and depression than SCZ patients at baseline and endpoint. On the other hand, we found that SUD patients had significantly more akathisia at baseline, improved more than SCZ patients and this was related to cannabis abuse/dependence. Finally, SUD patients improved more in PANSS positive scores than DD and SCZ patients. Taken together, our results provide evidence for increased vulnerability to the adverse effects of alcohol and drugs in schizophrenia patients. They also suggest that substance abuse/withdrawal may mimic some symptoms of schizophrenia. Future studies will need to determine the role quetiapine played in these improvements.

  13. Evaluation of Oral Stereognostic Ability After Rehabilitating Patients with Complete Dentures: In Vivo Study

    OpenAIRE

    Meenakshi, S.; Gujjari, Anil Kumar; Thippeswamy, H. N.; Raghunath, N.

    2013-01-01

    Stereognosis has been defined as the appreciation of the form of objects by palpation. Whilst this definition holds good for the manual exploration of objects, it is possible for the shape of objects to be explored intra orally referred to as oral stereognosis. To better understand patients’ relative satisfaction with complete dentures, differences in oral stereognostic perception, based on the identification of 6 edible objects was analyzed in a group of 30 edentulous individuals at 3 stages...

  14. Interferon alpha therapy for hepatitis C: treatment completion and response rates among patients with substance use disorders

    Directory of Open Access Journals (Sweden)

    Loftis Jennifer M

    2007-01-01

    Full Text Available Abstract Background Individuals with substance use disorders (SUDs are at increased risk for hepatitis C viral infection (HCV, and few studies have explored their treatment responses empirically. The objective of this study was to assess interferon alpha therapy (IFN completion and response rates among patients with HCV who had a history of comorbid SUDs. More data is needed to inform treatment strategies and guidelines for these patients. Using a medical record database, information was retrospectively collected on 307,437 veterans seen in the Veterans Integrated Service Network 20 (VISN 20 of the Veterans Healthcare Administration (VHA between 1998 and 2003. For patients treated with any type of IFN (including regular or pegylated IFN or combination therapy (IFN and ribavirin who had a known HCV genotype, IFN completion and response rates were compared among patients with a history of SUD (SUD+ Group and patients without a history of SUD (SUD- Group. Results Odds ratio analyses revealed that compared with the SUD- Group, the SUD+ Group was equally likely to complete IFN therapy if they had genotypes 2 and 3 (73.1% vs. 68.0%, and if they had genotypes 1 and 4 (39.5% vs. 39.9%. Within the sample of all patients who began IFN therapy, the SUD- and SUD+ groups were similarly likely to achieve an end of treatment response (genotypes 2 and 3, 52.8% vs. 54.3%; genotypes 1 and 4, 24.5% vs. 24.8% and a sustained viral response (genotypes 2 and 3, 42.6% vs. 41.1%; genotypes 1 and 4: 16.0% vs. 22.3%. Conclusion Individuals with and without a history of SUD responded to antiviral therapy for HCV at similar rates. Collectively, these findings suggest that patients who have co-morbid SUD and HCV diagnoses can successfully complete a course of antiviral therapy.

  15. Changes in serum lipids in patients with rheumatoid arthritis treated with a combination of tocilizumab and methotrexate compared with methotrexate alone for 24 weeks of observation

    Directory of Open Access Journals (Sweden)

    E. V. Udachkina

    2015-11-01

    Full Text Available Background. According to the some studies tocilizumab therapy (TCZ in patients with rheumatoid arthritis (RA is accompanied by deterioration of blood lipid profile. Aim. To study changes in serum lipid parameters in patients with RA treated with a combination of tocilizumab and methotrexate compared with methotrexate alone for 24 weeks of observation. Material and methods. Patients (n=72 with RA were included into the pilot non-randomized 24-week study and divided in two groups: 1 TCZ+MTX group (n=39; women 30; median age 51 [43-55] years; 6 i.v. infusions of TCZ 8 mg/kg + МТX 10-20 mg/week; 2 MTX group (n=33; women 23; mеdian age 56 [48-63] years; MTX 7.5-20 mg/week. Results. At the baseline, similar proatherogenic blood profile was observed in both groups. The patients of MTX group more frequently took statins (n=19; 57.6% compared with the group TCZ+MTX (n=7; 18%, (p<0.05. The lipid levels correlated positively with traditional risk factors (p<0.05. RA activity and duration correlated negatively with high density lipoprotein cholesterol (HDL-C, (p<0.05. Good/satisfactory anti-inflammatory effect was achieved in both groups after 24 weeks of treatment. Patients of TCZ+MTX group showed an increase in total cholesterol and HDL-C levels by 11% and 110%, respectively and decrease in plasma atherogenic index (PAI by 47%, (p<0.05. HDL-C level increased by 22% and PAI decreased by 16% in patients of MTX group (p<0.05. Among patients of MTX group without statin therapy HDL-C as well as non-HDL-C levels were increased by 24% and 27%, respectively (p<0.05; PAI did not change significantly in this subgroup. Among patients of MTX group treated with statins isolated increase in HDL-C level by 22% and decrease in PAI by 37.3% (p<0.05 were observed. A number of patients with achieved target levels of all studied lipid parameters did not change significantly in both groups. Conclusions. TCZ+MTX combined therapy as well as MTX monotherapy are associated

  16. Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study.

    Science.gov (United States)

    Tanaka, Yoshiya; Takeuchi, Tsutomu; Yamanaka, Hisashi; Nakamura, Hiroyuki; Toyoizumi, Shigeyuki; Zwillich, Samuel

    2015-07-01

    To evaluate oral tofacitinib versus placebo for treatment of active rheumatoid arthritis in Japanese patients with inadequate response to disease-modifying antirheumatic drugs. In this double-blind, placebo-controlled, randomized, parallel-group, 12-week, phase 2 study (clinicaltrials.gov NCT00687193), 317 patients received tofacitinib: 1, 3, 5, 10, or 15 mg as monotherapy or placebo twice daily (BID). response rate by American College of Rheumatology (ACR) ≥ 20% improvement criteria (ACR20) at week 12. ACR20 response rates: 37.7% (20/53), 67.9% (36/53), 73.1% (38/52), 84.9% (45/53), and 90.7% (49/54) with tofacitinib: 1, 3, 5, 10, and 15 mg BID, respectively, versus 15.4% (8/52) with placebo (p tofacitinib versus placebo occurred from week 2 onward (p tofacitinib versus placebo from week 4 (p tofacitinib patients experienced treatment-related serious adverse events (AEs). Most common treatment-emergent AEs: nasopharyngitis (10% vs 12%) and hyperlipidemia (5% vs 0%). Serum creatinine, hemoglobin, and total-, low-, and high-density lipoprotein-cholesterol levels increased with tofacitinib. Tofacitinib produced dose-dependent ACR20 responses and reduced disease activity. The safety profile was consistent with that reported from global monotherapy trials.

  17. Epoetin alfa 40000 U once weekly and intravenous iron supply in solid tumor patients: early increase of hemoglobin level during chemotherapy

    International Nuclear Information System (INIS)

    Lalle, M.; Antimi, M.; Pistillucci, G.; D'Aprile, M.

    2005-01-01

    The objective of this observational study was the early evaluation of the impact, a week after the first administration of epoetin alfa 40000 U once weekly and i.v. dose of 62.5 mg sodium ferric gluconate for seven days in improving hemoglobin levels in cancer patients affected by mild/moderate or severe anemia during chemotherapy. Twenty patients affected by solid tumors who received epoetin alfa 40000 U once weekly and daily i.v. sodium ferric gluconate for one week were evaluated: 90% of the patients showed hemoglobin increase, with a median level of hemoglobin increase of 0.73 g/L from baseline, and 50% of them showing a hemoglobin increase > 1 gr/L. The treatment was well tolerated and no adverse event was observed. The early increase of hemoglobin level from baseline is interesting and suggestive for the possibility of achieving an adequate hemoglobin level with a short-term treatment. It is still necessary to further explore the real need of iron supplementation to maintain adequate erythropoiesis prior and during epoetin therapy

  18. The role of complete overdentures in esthetic rehabilitation of the adolescent oligodontia patient. A case report.

    Science.gov (United States)

    Thalji, Ghadeer N; Cooper, Lyndon F

    2010-08-01

    Dental agenesis is a common developmental anomaly among human populations. It presents with varying degrees of severity. Oligodontia present in the permanent dentition may have significant esthetic, psychosocial, as well as functional implications. A case of oligodontia in an adolescent patient treated with conventional overdentures is presented in this article. A thorough medical and dental history were taken. Comprehensive clinical and radiographic examinations were made. Diagnostic casts were mounted. The prosthetic denture teeth were set and followed by esthetic and phonetic evaluation. Following approval by the patient, the overdentures were processed in heat cure resin using the conventional techniques. Good esthetic results were achieved. Patient was satisfied with the final prostheses. Simple prosthodontic solutions can be utilized to aid patients with dental agenesis. These have great implications for the patient's self image. Oligodontias are common. The literature frequently addresses esthetic rehabilitation using fixed prostheses and dental implants. This case report illustrates the value of removable prosthodontic procedures as one approach to fulfilling the requirements of esthetic rehabilitation of a young oligodontia patient.

  19. Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial

    International Nuclear Information System (INIS)

    Pignata, Sandro; Del Gaizo, Filomena; Naglieri, Emanuele; Ferro, Antonella; Musso, Pietro; D'Arco, Alfonso Maria; Sorio, Roberto; Pisano, Carmela; Di Maio, Massimo; Signoriello, Giuseppe; Annunziata, Annalisa; Scambia, Giovanni; Perrone, Francesco; Savarese, Antonella; Breda, Enrico; Scollo, Paolo; De Vivo, Rocco; Rossi, Emanuela; Gebbia, Vittorio; Natale, Donato

    2006-01-01

    The MITO-2 (Multicentre Italian Trials in Ovarian cancer) study is a randomized phase III trial comparing carboplatin plus paclitaxel to carboplatin plus pegylated liposomal doxorubicin in first-line chemotherapy of patients with ovarian cancer. Due to the paucity of published phase I data on the 3-weekly experimental schedule used, an early safety analysis was planned. Patients with ovarian cancer (stage Ic-IV), aged < 75 years, ECOG performance status ≤ 2, were randomized to carboplatin AUC 5 plus paclitaxel 175 mg/m 2 , every 3 weeks or to carboplatin AUC 5 plus pegylated liposomal doxorubicin 30 mg/m 2 , every 3 weeks. Treatment was planned for 6 cycles. Toxicity was coded according to the NCI-CTC version 2.0. The pre-planned safety analysis was performed in July 2004. Data from the first 50 patients treated with carboplatin plus pegylated liposomal doxorubicin were evaluated. Median age was 60 years (range 34–75). Forty-three patients (86%) completed 6 cycles. Two thirds of the patients had at least one cycle delayed due to toxicity, but 63% of the cycles were administered on time. In most cases the reason for chemotherapy delay was neutropenia or other hematological toxicity. No delay due to palmar-plantar erythrodysesthesia (PPE) was recorded. No toxic death was recorded. Reported hematological toxicities were: grade (G) 3 anemia 16%, G3/G4 neutropenia 36% and 10% respectively, G3/4 thrombocytopenia 22% and 4% respectively. Non-haematological toxicity was infrequent: pulmonary G1 6%, heart rhythm G1 4%, liver toxicity G1 6%, G2 4% and G3 2%. Complete hair loss was reported in 6% of patients, and G1 neuropathy in 2%. PPE was recorded in 14% of the cases (G1 10%, G2 2%, G3 2%). This safety analysis shows that the adopted schedule of carboplatin plus pegylated liposomal doxorubicin given every 3 weeks is feasible as first line treatment in ovarian cancer patients, although 37% of the cycles were delayed due to haematological toxicity. Toxicities that are

  20. Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial

    Directory of Open Access Journals (Sweden)

    D'Arco Alfonso

    2006-08-01

    Full Text Available Abstract Background The MITO-2 (Multicentre Italian Trials in Ovarian cancer study is a randomized phase III trial comparing carboplatin plus paclitaxel to carboplatin plus pegylated liposomal doxorubicin in first-line chemotherapy of patients with ovarian cancer. Due to the paucity of published phase I data on the 3-weekly experimental schedule used, an early safety analysis was planned. Methods Patients with ovarian cancer (stage Ic-IV, aged 2, every 3 weeks or to carboplatin AUC 5 plus pegylated liposomal doxorubicin 30 mg/m2, every 3 weeks. Treatment was planned for 6 cycles. Toxicity was coded according to the NCI-CTC version 2.0. Results The pre-planned safety analysis was performed in July 2004. Data from the first 50 patients treated with carboplatin plus pegylated liposomal doxorubicin were evaluated. Median age was 60 years (range 34–75. Forty-three patients (86% completed 6 cycles. Two thirds of the patients had at least one cycle delayed due to toxicity, but 63% of the cycles were administered on time. In most cases the reason for chemotherapy delay was neutropenia or other hematological toxicity. No delay due to palmar-plantar erythrodysesthesia (PPE was recorded. No toxic death was recorded. Reported hematological toxicities were: grade (G 3 anemia 16%, G3/G4 neutropenia 36% and 10% respectively, G3/4 thrombocytopenia 22% and 4% respectively. Non-haematological toxicity was infrequent: pulmonary G1 6%, heart rhythm G1 4%, liver toxicity G1 6%, G2 4% and G3 2%. Complete hair loss was reported in 6% of patients, and G1 neuropathy in 2%. PPE was recorded in 14% of the cases (G1 10%, G2 2%, G3 2%. Conclusion This safety analysis shows that the adopted schedule of carboplatin plus pegylated liposomal doxorubicin given every 3 weeks is feasible as first line treatment in ovarian cancer patients, although 37% of the cycles were delayed due to haematological toxicity. Toxicities that are common with standard combination of carboplatin

  1. Effect of A One-Week Balanced Diet on Expression of Genes Related to Zinc Metabolism and Inflammation in Type 2 Diabetic Patients.

    Science.gov (United States)

    Lais, Lucia Leite; de Lima Vale, Sancha Helena; Xavier, Camila Alves; de Araujo Silva, Alfredo; Aydemir, Tolunay Beker; Cousins, Robert J

    2016-01-01

    To evaluate the effect of diet on metabolic control and zinc metabolism in patients with type 2 diabetes mellitus (T2DM). One-week balanced diet was provided to 10 Brazilians patients with T2DM. Nutritional assessment, laboratorial parameters and expression of zinc transporter and inflammatory genes in peripheral blood mononuclear cells (PBMC) were performed. Healthy non-diabetic subjects of the same demographic were recruited to provide baseline data. Diabetic patients had higher body mass index and greater fasting plasma glucose, plasma tumor necrosis factor α (TNFα) and plasma interleukin 6 (IL6) levels compared with healthy subjects. In addition, the expression of transporters 4 (ZnT4) mRNA was lower and IL6 mRNA was higher in PBMC of these diabetic patients than in healthy subject. One week after a balanced diet was provided, fasting plasma glucose decreased significantly as did TNFα, IL6 and Metallothionein 1 (MT1) mRNAs. No change was observed in zinc transporter expression in PBMC after the dietary intervention. A healthy eating pattern maintained for one week was able to improve metabolic control of diabetic patients by lowering fasting plasma glucose. This metabolic control may be related to down-regulation of zinc-related transcripts from PBMCs, as TNFα, IL6 and MT1 mRNA.

  2. A systematic review of patient reported factors associated with uptake and completion of cardiovascular lifestyle behaviour change

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    Murray Jenni

    2012-12-01

    Full Text Available Abstract Background Healthy lifestyles are an important facet of cardiovascular risk management. Unfortunately many individuals fail to engage with lifestyle change programmes. There are many factors that patients report as influencing their decisions about initiating lifestyle change. This is challenging for health care professionals who may lack the skills and time to address a broad range of barriers to lifestyle behaviour. Guidance on which factors to focus on during lifestyle consultations may assist healthcare professionals to hone their skills and knowledge leading to more productive patient interactions with ultimately better uptake of lifestyle behaviour change support. The aim of our study was to clarify which influences reported by patients predict uptake and completion of formal lifestyle change programmes. Methods A systematic narrative review of quantitative observational studies reporting factors (influences associated with uptake and completion of lifestyle behaviour change programmes. Quantitative observational studies involving patients at high risk of cardiovascular events were identified through electronic searching and screened against pre-defined selection criteria. Factors were extracted and organised into an existing qualitative framework. Results 374 factors were extracted from 32 studies. Factors most consistently associated with uptake of lifestyle change related to support from family and friends, transport and other costs, and beliefs about the causes of illness and lifestyle change. Depression and anxiety also appear to influence uptake as well as completion. Many factors show inconsistent patterns with respect to uptake and completion of lifestyle change programmes. Conclusion There are a small number of factors that consistently appear to influence uptake and completion of cardiovascular lifestyle behaviour change. These factors could be considered during patient consultations to promote a tailored approach to

  3. Long-term clinical parameters after switching to nocturnal haemodialysis : a Dutch propensity-score-matched cohort study comparing patients on nocturnal haemodialysis with patients on three-times-a-week haemodialysis/haemodiafiltration

    NARCIS (Netherlands)

    Jansz, Thijs Thomas; Özyilmaz, Akin; Grooteman, Muriel P C; Hoekstra, Tiny; Romijn, Marieke; Blankestijn, Peter J; Bots, Michael L; van Jaarsveld, Brigit C

    2018-01-01

    OBJECTIVES: Nocturnal haemodialysis (NHD), characterised by 8-hour sessions ≥3 times a week, is known to improve clinical parameters in the short term compared with conventional-schedule haemodialysis (HD), generally 3×3.5-4 hours a week. We studied long-term effects of NHD and used patients on

  4. Vildagliptin versus insulin in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea: results from a randomized, 24 week study.

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    Forst, Thomas; Koch, Cornelia; Dworak, Markus

    2015-06-01

    There is limited evidence to guide the selection of second-line anti-hyperglycemic agents in patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with sulfonylurea monotherapy and are intolerant to metformin. We compared the efficacy and safety of vildagliptin 50 mg qd and Neutral Protamine Hagedorn (NPH) insulin qd in such patients. This was a 24 week, multicenter, randomized, open-label study. The co-primary endpoints were (i) proportion of patients achieving HbA1c vildagliptin (n = 83) and NPH insulin (n = 79). Similar proportion of patients achieved the composite endpoint in vildagliptin versus NPH insulin group (35.4% versus 34.2%; OR 0.985; 95% CI 0.507, 1.915; p = 0.96). After 24 weeks, 48.8% of patients in the vildagliptin group and 60.8% in the NPH insulin group achieved HbA1c vildagliptin group and 29.1% in the insulin group had at least one confirmed HE; while 11.0% in the vildagliptin group and 22.8% in the insulin group experienced weight gain. The rate of confirmed HEs was significantly lower in patients receiving vildagliptin versus NPH insulin (1.3 versus 5.1 events per year). The TSQM-9 score for 'convenience' at week 24 increased significantly more with vildagliptin than with NPH insulin. Addition of vildagliptin and NPH insulin resulted in a similar number of patients reaching HbA1c target without HEs or weight gain in T2DM patients inadequately controlled with sulfonylurea. The addition of vildagliptin to sulfonylurea could be considered as a treatment option prior to intensification with insulin, with the advantages of a lower HE rate and greater patient convenience. Study results are limited by a higher drop-out rate in the vildagliptin arm.

  5. Effect of 8 weeks resistance training on plasma levels of nerve growth factor and interlukin-6 in female patients with multiple sclerosis

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    Mehrzad Moghadasi

    2015-07-01

    Full Text Available Background: In recent years, evidence from a number of studies has suggested that exercise is a safe and efficient way to induce improvements in a number of physiological functions in multiple sclerosis (MS patients, but the effects of exercise on nerve growth factor (NGF and interlukin-6 (IL-6 in these patients are not well known. Thus, the purpose of this study was to evaluate the effect of 8 weeks resistance training on plasma NGF and IL-6 in female patients with MS. Materials and methods: Thirty two female MS patients with 32.4±5.5 years of old, and expanded disability status scale (EDSS 0-4.5, participated in this study. The subjects were randomly assigned to control group (n=13 and training group (n=14. Subjects in training group performed selected upper and lower extremities resistance training with weight-training equipment and rubber bands 3 days a week for 8 weeks. Body composition parameters, NGF and IL-6 levels were measured before and after the intervention. Results: The results showed that body weight, body mass index, body fat mass and EDSS were decreased significantly after 8 weeks in training group compared to control group (P<0.05. Also, no significant differences were seen after the intervention in NGF and IL-6 between the training and control groups. Conclusion: The results suggest resistance training with specific intensity and duration utilized in this study improves EDSS in female patients with MS but it has no effecting on NGF and IL-6 in these patients.

  6. Successful Fitting of a Complete Maxillary Denture in a Patient with Severe Alzheimer’s Disease Complicated by Oral Dyskinesia

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    Hiromitsu Morita

    2016-01-01

    Full Text Available There is an increasing population of elderly patients suffering from Alzheimer’s disease (AD, the most common form of dementia. In dentistry, a critical problem associated with these patients is the use of a new denture, as AD patients often refuse dental management and are disturbed by minor changes in their oral environment. Some AD patients have further complications associated with oral dyskinesia, a movement disorder that can make dental management difficult, including the stability of a complete denture. In this case, we successfully fitted a complete maxillary denture using modified bilateral balanced occlusion after multiple tooth extractions under intravenous sedation in a 66-year-old woman with severe AD complicated by oral dyskinesia. Following treatment, her appetite and food intake greatly improved. Providing a well-fitting complete denture applied by modified bilateral balanced occlusion, which removes lateral interference using zero-degree artificial teeth for movement disorder of the jaw in patients with severe AD complicated by oral dyskinesia, helps improve oral function.

  7. Cardiac patients who completed a longitudinal psychosocial study had a different clinical and psychosocial baseline profile than patients who dropped out prematurely

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    Damen, Nikki L; Versteeg, Henneke; Serruys, Patrick W

    2013-01-01

    drop-outs may have a different cardiovascular risk. We studied a cohort of 1132 consecutive patients undergoing percutaneous coronary intervention (PCI). At baseline, all patients completed the Hospital Anxiety and Depression Scale (HADS) and the Type D Scale (DS14). At 12 months follow-up, 70.8% (n...... cardiovascular medications, including calcium antagonists and angiotensin-converting enzyme inhibitors, as compared with completers. Drop-outs more often had depression, anxiety, and negative affectivity, as compared with completers (all p-values......Non-response is a serious threat to the external validity of longitudinal psychosocial studies. Little is known about potential systematic differences between patients with coronary artery disease who complete a psychosocial study and those who drop out prematurely due to non-response, or whether...

  8. Reversible complete atrioventricular block in patient with wegener's granulomatosis - a report on fortunate outcome with long term follow-up.

    Science.gov (United States)

    Steckiewicz, Roman; Rosiak, Marek; Stolarz, Przemysław; Świętoń, Elżbieta B; Grabowski, Marcin; Kosior, Dariusz A

    Reversible complete atrioventricular block in patient with Wegener's granulomatosis - a report on a positive outcome with long term follow-up. Atrioventricular (AV) block is a rare complication of Wegener's granulomatosis (WG), thus there are no standards of management in such cases. We present a case of a patient with a dual-chamber pacemaker (DDD) implanted due to complete AV block in the course of Wegener's granulomatosis (WG). An immunosuppressive therapy resulted in the resolution of non-cardiac and AV conduction disorders. The diagnostic functions of the pacemaker enabled us to evaluate AV conduction over a five-year follow-up period. The resolution of AV conduction disorders, which accompanied WG remission, suggests that careful monitoring with temporary cardiac pacing may be considered in some patients before permanent pacemaker implantation.

  9. Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study.

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    Jesús Troya

    Full Text Available Based on data from clinical practice, we evaluated the effectiveness and safety of switching to abacavir/lamivudine plus rilpivirine (ABC/3TC+RPV treatment in virologically suppressed HIV-1-infected patients.We performed a multicenter, non-controlled, retrospective study of HIV-1-infected patients who switched treatment to ABC/3TC+RPV. Patients had an HIV-RNA <50 copies/mL for at least 24 weeks prior to changing treatments. The primary objective was HIV-1 RNA <50 copies/mL at week 48. Effectiveness was analyzed by intention-to-treat (ITT, missing = failure and on-treatment (OT analyses. The secondary objectives analyzed were adverse effects changes in renal, hepatic or lipid profiles, changes in CD4+ cell count and treatment discontinuations.Of the 205 patients included, 75.6% were men and the median age was 49. At baseline, before switching to ABC/3TC+RPV, median time since HIV diagnosis was 13.1 years, median time with undetectable HIV-1 RNA was 6.2 years and median time of previous antiretroviral regimen was 3.1 years (48.3% patients were taking efavirenz and ABC/3TC was the most frequent backbone coformulation in 69.7% of patients. The main reasons for switching were drug toxicity/poor tolerability (60.5% and simplification (20%. At week 48, the primary objective was achieved by 187 out of 205 (91.2% patients by ITT analysis, and 187 out of 192 (97.4% patients by OT analysis. The CD4+ lymphocyte count and CD4+ percentage increased significantly from baseline to week 48 by a median of 48 cells/μL (-50 to 189 and 1.2% (-1.3% to 4.1%, respectively, P<0.001. Thirty-eight adverse events (AE were detected in 32 patients. Of these, 25 had no clear association with treatment. Three patients interrupted therapy due to AE. We observed a decrease in all lipid parameters, P<0.001, and a slight improvement in the glomerular filtration rate, P<0.01. Therapy was considered to have failed in 18 patients owing to virological failure (5 [2.4%], toxicity

  10. Complete remission in a colon cancer patient with a large, irresectable liver metastasis after XELOX/cetuximab/bevacizumab treatment.

    Science.gov (United States)

    Weihrauch, Martin R; Stippel, Dirk; Fries, Jochen W U; Arnold, Dirk; Bovenschulte, Henning; Coutelle, Oliver; Hacker, Ulrich

    2008-09-01

    Stage IV colorectal cancer is usually an incurable disease. However, patients with resectable metastases have 5-year disease-free survival rates of up to 30%. Even with primarily irresectable disease, cure can be achieved in patients who become operable after neoadjuvant treatment. To improve the prognosis of these patients, highly effective neoadjuvant regimens need to be developed. Here, we report the case of a 62-year-old male patient who had been diagnosed with International Union against Cancer (UICC) stage III colon cancer 7 years previously and now presented with a large, irresectable liver metastasis and enlarged perihepatic lymph nodes. After neoadjuvant treatment with cetuximab, bevacizumab and XELOX, the patient showed a complete remission and underwent surgery. Histopathologically, the resected tissue and lymph nodes were free of residual tumor. To our knowledge, this is the first report of a complete pathological response in a patient with irresectable colorectal cancer after intensive chemotherapy/anti-EGFR/ VEGF antibody therapy. This combination regimen may help to improve the survival rates for patients with irresectable disease. Copyright 2008 S. Karger AG, Basel.

  11. Should edentulous patients be constrained to removable complete dentures? The use of dental implants to improve the quality of life for edentulous patients.

    Science.gov (United States)

    Turkyilmaz, Ilser; Company, Andrea M; McGlumphy, Edwin A

    2010-03-01

    Nowadays, there is some speculation among dental educators that the need for complete dentures will significantly decrease in the future and that training in their provision should be removed from the dental curriculum. To sensitise the reader to the functional shortcomings of complete denture therapy in the edentulous patient and present restorative options including implants to improve edentulous quality of life in these patients. Information retrieval followed a systematic approach using PubMed. English articles published from 1964 to 2008, in which the masticatory performance of patients with implant-supported dentures was assessed by objective methods and compared with performance with conventional dentures, were included. National epidemiological survey data suggested that the adult population in need of one or two complete dentures will increase from 35.4 million adults in 2000 to 37.9 million adults in 2020. Clinical studies have showed that the ratings of general satisfaction were significantly better in the patients treated with implant overdentures post-delivery compared with the complete denture users. In addition, the implant group gave significantly higher ratings on comfort, stability and ability to chew. Furthermore, patients who received mandibular implant overdentures had significantly fewer oral health-related quality of life problems than did the conventional group. Implant-supported dentures including either complete overdentures or a hybrid prosthesis significantly improve the quality of life for edentulous patients compared with conventional removable complete dentures. Therefore, the contemporary dental practitioner should consider other options as well as conventional removable complete dentures to restore edentulous patients.

  12. Phase II study of paclitaxel given once per week along with trastuzumab and pertuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer.

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    Dang, Chau; Iyengar, Neil; Datko, Farrah; D'Andrea, Gabriella; Theodoulou, Maria; Dickler, Maura; Goldfarb, Shari; Lake, Diana; Fasano, Julie; Fornier, Monica; Gilewski, Theresa; Modi, Shanu; Gajria, Devika; Moynahan, Mary Ellen; Hamilton, Nicola; Patil, Sujata; Jochelson, Maxine; Norton, Larry; Baselga, Jose; Hudis, Clifford

    2015-02-10

    The CLEOPATRA (Clinical Evaluation of Trastuzumab and Pertuzumab) study demonstrated superior progression-free survival (PFS) and overall survival when pertuzumab was added to trastuzumab and docetaxel. Paclitaxel given once per week is effective and less toxic than docetaxel. We performed a phase II study to evaluate the efficacy and safety of pertuzumab and trastuzumab with paclitaxel given once per week. Patients with metastatic human epidermal growth factor receptor 2-positive breast cancer with zero to one prior therapy were enrolled. Treatment consisted of paclitaxel 80 mg/m(2) once per week plus trastuzumab (8 mg/kg loading dose → 6 mg/kg) once every 3 weeks plus pertuzumab (840 mg loading dose → 420 mg) once every 3 weeks, all given intravenously. The primary end point was 6-month PFS assessed by Kaplan-Meier methods. From January 2011 to December 2013, we enrolled 69 patients: 51 (74%) and 18 (26%) treated in first- and second-line metastatic settings, respectively. At a median follow-up of 21 months (range, 3 to 38 months), 6-month PFS was 86% (95% CI, 75% to 92%). The median PFS was 19.5 months (95% CI, 14 to 26 months) overall. PFS was 24.2 months (95% CI, 14 months to not reached [NR]) and 16.4 months (95% CI, 8.5 months to NR) for those without and with prior treatment, respectively. At 1 year, Kaplan-Meier PFS was 70% (95% CI, 56% to 79%) overall, 71% (95% CI, 55% to 82%) for those without prior therapy, and 66% (95% CI, 40% to 83%) for those with prior therapy. Treatment was well-tolerated; there was no febrile neutropenia or symptomatic left ventricular systolic dysfunction. Paclitaxel given once per week with trastuzumab and pertuzumab is highly active and well tolerated and seems to be an effective alternative to docetaxel-based combination therapy. © 2014 by American Society of Clinical Oncology.

  13. Cost-effectiveness analysis of an 18-week exercise programme for patients with breast and colon cancer undergoing adjuvant chemotherapy: the randomised PACT study.

    Science.gov (United States)

    May, Anne M; Bosch, Marcel J C; Velthuis, Miranda J; van der Wall, Elsken; Steins Bisschop, Charlotte N; Los, Maartje; Erdkamp, Frans; Bloemendal, Haiko J; de Roos, Marnix A J; Verhaar, Marlies; Ten Bokkel Huinink, Daan; Peeters, Petra H M; de Wit, G Ardine

    2017-03-06

    Meta-analyses show that exercise interventions during cancer treatment reduce cancer-related fatigue. However, little is known about the cost-effectiveness of such interventions. Here we aim to assess the cost-effectiveness of the 18-week physical activity during cancer treatment (PACT) intervention for patients with breast and colon cancer. The PACT trial showed beneficial effects for fatigue and physical fitness. Cost-effectiveness analyses with a 9-month time horizon (18 weeks of intervention and 18 weeks of follow-up) within the randomised controlled multicentre PACT study. Outpatient clinics of 7 hospitals in the Netherlands (1 academic and 6 general hospitals) PARTICIPANTS: 204 patients with breast cancer and 33 with colon cancer undergoing adjuvant treatment including chemotherapy. Supervised 1-hour aerobic and resistance exercise (twice per week for 18 weeks) or usual care. Costs, quality-adjusted life years (QALY) and the incremental cost-effectiveness ratio. For colon cancer, the cost-effectiveness analysis showed beneficial effects of the exercise intervention with incremental costs savings of €4321 and QALY improvements of 0.03. 100% of bootstrap simulations indicated that the intervention is dominant (ie, cheaper and more effective). For breast cancer, the results did not indicate that the exercise intervention was cost-effective. Incremental costs were €2912, and the incremental effect was 0.01 QALY. At a Dutch threshold value of €20 000 per QALY, the probability that the intervention is cost-effective was 2%. Our results suggest that the 18-week exercise programme was cost-effective for colon cancer, but not for breast cancer. ISRCTN43801571. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. Cost per successfully treated patient for vortioxetine versus duloxetine in adults with major depressive disorder: an analysis of the complete symptoms of depression and functional outcome.

    Science.gov (United States)

    Christensen, Michael Cronquist; Munro, Vicki

    2018-04-01

    To determine the cost-effectiveness of vortioxetine vs duloxetine in adults with moderate-to-severe major depressive disorder (MDD) in Norway using a definition of a successfully treated patient (STP) that incorporates improvement in both mood symptoms and functional capacity. Using the population of patients who completed the 8-week CONNECT study, the cost-effectiveness of vortioxetine (n = 168) (10-20 mg/day) vs duloxetine (n = 176) (60 mg/day) was investigated for the treatment of adults in Norway with moderate-to-severe MDD and self-reported cognitive dysfunction over an 8-week treatment period. Cost-effectiveness was assessed in terms of cost per STP, defined as improvement in mood symptoms (≥50% decrease from baseline in Montgomery-Åsberg Depression Rating Scale total score) and change in UCSD [University of California San Diego] performance-based skills assessment [UPSA] score of ≥7. The base case analysis utilized pharmacy retail price (apotek utsalgspris (AUP)) for branded vortioxetine (Brintellix) and branded duloxetine (Cymbalta). After 8 weeks of antidepressant therapy, there were more STPs with vortioxetine than with duloxetine (27.4% vs 22.5%, respectively). The mean number needed to treat for each STP was 3.6 for vortioxetine and 4.4 for duloxetine, resulting in a lower mean cost per STP for vortioxetine (NOK [Norwegian Kroner] 3264) than for duloxetine (NOK 3310) and an incremental cost per STP of NOK 3051. The use of a more challenging change in the UPSA score from baseline (≥9) resulted in a mean cost per STP of NOK 3822 for vortioxetine compared with NOK 3983 for duloxetine and an incremental cost per STP of NOK 3181. Vortioxetine may be a cost-effective alternative to duloxetine, owing to its superior ability to improve functional capacity. The dual-response STP concept introduced here represents a more comprehensive analysis of the cost-effectiveness of antidepressants.

  15. Weekly Cisplatin and Volumetric-Modulated Arc Therapy With Simultaneous Integrated Boost for Radical Treatment of Advanced Cervical Cancer in Elderly Patients: Feasibility and Clinical Preliminary Results

    Science.gov (United States)

    Mazzola, Rosario; Ricchetti, Francesco; Fiorentino, Alba; Levra, Niccolò Giaj; Fersino, Sergio; Di Paola, Gioacchino; Ruggieri, Ruggero

    2016-01-01

    Background: To evaluate the feasibility and clinical preliminary results of weekly cisplatin and volumetric-modulated arc therapy to the pelvis with simultaneous integrated boost to macroscopic disease in a cohort of elderly patients. Materials and Methods: Inclusion criteria of this prospective study were age ≥70 years, Karnofsky performance status 70 to 100, locally advanced histologically proven squamous cervical carcinoma, and patients unable to undergo brachytherapy. Radiation doses prescribed were 66 Gy to the macroscopic disease and 54 Gy to the pelvic nodes in 30 fractions. Weekly cisplatin dose was 40 mg/mq. Results: A total of 30 patients were recruited. Median follow-up was 32 months (range: 8-48 months). Median age was 72 years (range: 70-84 years). The 3-year overall survival and local control were 93% and 80%, respectively. The median time to progression was 24 months (range: 6-30 months). Analyzing clinical outcome grouping based on the stage of disease, II versus III, the 3-year overall survival was 100% and 85%, respectively. The 3-year local control was 91% for stage II and 67% for stage III. Acute and late toxicities were acceptable without severe events. Conclusion: Weekly cisplatin and volumetric-modulated arc therapy–simultaneous integrated boost for radical treatment of advanced cervical cancer in the current cohort of elderly patients were feasible. Long-term results and prospective randomized trials are advocated. PMID:27402633

  16. Relationship between self-reported pain sensitivity and pain after total knee arthroplasty: a prospective study of 71 patients 8 weeks after a standardized fast-track

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    Valeberg BT

    2016-09-01

    Full Text Available Berit T Valeberg,1 Lise H Høvik,2 Kari H Gjeilo3–6 1Faculty of Nursing, Oslo and Akershus University College of Applied Sciences, Oslo, 2Clinic of Anaesthesia and Intensive Care Medicine, St. Olavs Hospital, Trondheim University Hospital, 3Department of Cardiothoracic Surgery, 4Department of Cardiology, 5National Competence Centre for Complex Symptom Disorders, St. Olavs Hospital, Trondheim University Hospital, 6Department of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway Background and purpose: This was a prospective cohort study assessing data from 71 adult patients undergoing total knee arthroplasty (TKA following a standardized fast-track program between January and July 2013. The objective was to examine the relationship between self-rated pain sensitivity, as measured by the Pain Sensitivity Questionnaire (PSQ, and postoperative pain after TKA. Methods: The baseline questionnaires, PSQ and Brief Pain Inventory, were given to the patients for self-administration at the presurgical evaluation (1–2 weeks prior to surgery. The follow-up questionnaire, Brief Pain Inventory, was administered at the first follow-up, 8 weeks after surgery. Results: A statistically significant association was found between average preoperative pain and average pain 8 weeks after surgery (P=0.001. The PSQ-minor was statistically significantly associated with average pain only for patients younger than 70 years (P=0.03. Interpretation: This is the first study to examine the relationship between pain sensitivity measured by PSQ and postoperative pain in patients after TKA. We found that a lower score on the PSQ-minor was statistically significantly associated with patients’ pain 8 weeks after TKA surgery, but only for younger patients. Further research is needed to explore whether the PSQ could be a useful screening tool for patients’ pain sensitivity in clinical settings. Keywords

  17. The risks, needs and stages of recovery of a complete forensic patient cohort in an Australian state.

    Science.gov (United States)

    Adams, Jonathon; Thomas, Stuart D M; Mackinnon, Tobias; Eggleton, Damien

    2018-02-07

    Routine outcome measures are increasingly being mandated across mental health services in Australia and overseas. This requirement includes forensic mental health services, but their utility in such specialist services and the inter-relationships between the measures remain unclear. This study sought to characterise the risks, needs and stages of recovery of an entire cohort of forensic patients in one jurisdiction in Australia. Local expert groups, comprising of members of the forensic patient treating teams, were formed to gather information about the status and needs of all forensic patients in the State of New South Wales, Australia. The expert groups provided demographic information and completed three assessment tools concerning the risks, needs and stages of recovery of each forensic patient. The cohort of 327 forensic patients in NSW appears to be typical of forensic mental health service populations internationally when considering factors such as gender, diagnosis, and index offence. A number of important differences across the three structured tools for forensic patients in different levels of secure service provision are presented. The DUNDRUM Quartet demonstrated interesting findings, particularly in terms of the therapeutic security needs, the treatment completion, and the stages of recovery for the forensic patients in the community. The CANFOR highlighted the level of needs across the forensic patient population, whilst the HCR-20 data showed there was no significant difference in the mean clinical and risk management scores between male forensic patients across levels of security. To the authors' knowledge this is the first study of its kind in New South Wales, Australia. We have demonstrated the utility of using a suite of measures to evaluate the risks, needs, and stages of recovery for an entire cohort of forensic patients. The data set helps inform service planning and development, together with providing various avenues for future research.

  18. Ziprasidone versus olanzapine, risperidone or quetiapine in patients with chronic schizophrenia: a 12-week open-label, multicentre clinical trial

    DEFF Research Database (Denmark)

    Lublin, Henrik; Haug, Hans-Joachim; Koponen, Hannu

    2009-01-01

    The efficacy, safety and tolerability of ziprasidone versus the comparators olanzapine, risperidone or quetiapine were investigated in adult patients with chronic schizophrenia, schizoaffective and schizophreniform disorders, with lack of efficacy or intolerance to their previous antipsychotic tr...

  19. Lower etanercept levels are associated with high disease activity in ankylosing spondylitis patients at 24 weeks of follow-up

    NARCIS (Netherlands)

    Kneepkens, E. L.; Krieckaert, C. L. M.; van der Kleij, D.; Nurmohamed, M. T.; van der Horst-Bruinsma, I. E.; Rispens, T.; Wolbink, G. J.

    2015-01-01

    Previous data have shown that etanercept levels are associated with clinical response in rheumatoid arthritis. However, for ankylosing spondylitis (AS), data regarding this topic are inconclusive. To investigate the relationship between etanercept levels and clinical response in patients with AS.

  20. The role of radiography in primary care patients with low back pain of at least 6 weeks duration. A randomised (unblinded) controlled trial

    International Nuclear Information System (INIS)

    Kendrick, D.; Fielding, K.; Bentley, E.; Miller, P.; Kerslake, R.; Pringle, M.

    2001-01-01

    Lumbar spine radiography in primary care patients with low back pain of at least 6 weeks duration is not associated with improved functioning, severity of pain or overall health status, and is associated with an increase in GP workload. Participants receiving X-rays are more satisfied with their care, but are not less worried or more reassured about serious disease causing their low back pain

  1. The role of radiography in primary care patients with low back pain of at least 6 weeks duration. A randomised (unblinded) controlled trial

    Energy Technology Data Exchange (ETDEWEB)

    Kendrick, D.; Fielding, K.; Bentley, E.; Miller, P.; Kerslake, R.; Pringle, M

    2001-09-01

    Lumbar spine radiography in primary care patients with low back pain of at least 6 weeks duration is not associated with improved functioning, severity of pain or overall health status, and is associated with an increase in GP workload. Participants receiving X-rays are more satisfied with their care, but are not less worried or more reassured about serious disease causing their low back pain.

  2. Non-invasive assessment of liver fibrosis progression in hepatitis C patients retreated for 96 weeks with antiviral therapy: a randomized study.

    Science.gov (United States)

    Zarski, Jean-Pierre; Sturm, Nathalie; Desmorat, Hervé; Melin, Pascal; Raabe, Jean-Jacques; Bonny, Corinne; Sogni, Philippe; Pinta, Alexandrina; Rouanet, Stéphanie; Babany, Gérard; Cheveau, Alice; Chevallier, Michèle

    2010-08-01

    The efficacy of a maintenance therapy in non-responder patients with chronic hepatitis C has been essentially evaluated by histological semiquantitative scores. The aim was to evaluate the efficiency of 2 years of treatment with peginterferon alpha-2a vs alpha-tocopherol in these patients by histology, morphometry and blood markers of fibrosis. Hundred and five HCV patients with a Metavir fibrosis score > or = 2 were randomized to receive peginterferon alpha-2a 180 microg/week (PEG) (n=55) or alpha-tocopherol (TOCO) 1000 mg/day (n=50) for 96 weeks. The primary endpoint was improvement or stabilization of the Metavir fibrosis score by biopsy performed at week 96. Secondary endpoints included a quantitative assessment of fibrosis by morphometry and changes in blood markers of fibrosis. There was no difference at baseline between PEG and TOCO according to the metavir (83.3 vs 86.8%, P=0.751) stage. The median fibrosis rate, measured with morphometry was 2.72 and 2.86% at day 0, and 3.66 and 2.82% at week 96, in the PEG and TOCO groups (P=0.90) respectively. However, the percentage of patients with metavir activity grade improvement was significantly higher in the PEG group vs the TOCO group (52.8 vs 23.7%, P=0.016). Non-invasive markers analysis did not show any significant change in both groups. Long-term therapy with peginterferon alpha-2a did not reduce liver fibrosis degree assessed by morphometry and blood tests as compared with alpha-tocopherol. Blood tests could be useful to assess liver fibrosis changes in clinical trials.

  3. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial

    Directory of Open Access Journals (Sweden)

    Rinaldo Massimo

    2011-02-01

    Full Text Available Abstract Background To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. Methods Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. Results From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03; patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p Conclusions In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. Trial registration ClinicalTrials.gov NCT00540800.

  4. [Complete hormonal and metabolic response after iodine-131 metaiodobenzylguanidine treatment in a patient diagnosed of malignant pheochromocytoma].

    Science.gov (United States)

    García Alonso, M P; Balsa Bretón, M A; Paniagua Correa, C; Castillejos Rodríguez, L; Rodríguez Pelayo, E; Mendoza Paulini, A; Ortega Valle, A; Penín González, J

    2013-01-01

    Radiolabeled metaiodobenzylguanidine is an analogue of norepinephrine used to localize tumors that express the neurohormone transporters, specifically those derived from the neural crest having a neuroendocrine origin. It is also used to treat non-surgical metastases derived from them. A review of the literature revealed symptomatic improvements associated to a decrease in hormone levels in a significant percentage of patients after (131)I-MIBG treatment. However, complete tumor remission has been described only in very few cases and hardly ever when bone metastases exist. We present a case of a patient diagnosed of malignant pheochromocytoma who achieved complete hormonal and metabolic response after (131)I-MIBG treatment (600 mCi) in spite of the presence of bone metastases. Copyright © 2012 Elsevier España, S.L. and SEMNIM. All rights reserved.

  5. Restoration of facial symmetry in a patient with bell palsy using a modified maxillary complete denture: a case report.

    Science.gov (United States)

    Bagchi, Gautam; Nath, Dilip Kumar

    2012-01-01

    Permanent facial paralysis can be devastating for a patient. Modern society's emphasis on appearance and physical beauty contributes to this problem and often leads to isolation of patients embarrassed by their appearance. Lagophthalmos with ocular exposure, loss of oral competence with resultant drooling, alar collapse with nasal airway obstruction, and difficulties with mastication and speech production are all potential consequences of facial paralysis. Affected patients are confronted with both a cosmetic defect and the functional deficits associated with loss of facial nerve function. In this case history report, a modified maxillary complete denture permitted a patient with Bell palsy to carry on daily activities with minimal facial distortion, pain, speech difficulty, and associated emotional trauma.

  6. A Comparative Study Between Two Sensory Stimulation Strategies After Two Weeks Treatment on Older Patients with Oropharyngeal Dysphagia.

    Science.gov (United States)

    Ortega, Omar; Rofes, Laia; Martin, Alberto; Arreola, Viridiana; López, Irene; Clavé, Pere

    2016-10-01

    Oropharyngeal dysphagia (OD) is a prevalent geriatric syndrome. Treatment is based on compensatory strategies to avoid complications. New treatments based on sensory stimulation to promote the recovery of the swallowing function have proved effective in acute studies but prolonged treatment needs further research. Our aim was to evaluate and compare the effect of two, longer-term sensory treatment strategies on older patients with OD. 38 older patients (≥70 years) were studied with videofluoroscopy (pre/posttreatment) and randomized into two 10-day treatment groups: Group A-transient receptor potential vanilloid 1 (TRPV1) agonist (capsaicin 1 × 10(-5) M) and Group B-transcutaneous sensory electrical stimulation (TSES) (Intelect VitalStim, biphasic pulses, 300 μs, 80 Hz). Patients were analyzed for treatment response. Patients were old (80.47 ± 5.2 years), with comorbidities (3.11 ± 1.59 Charlson Index), polymedication (8.92 ± 3.31 drugs/patient), and mild functional impairment (86.84 ± 17.84 Barthel Index), and 28.9 % were at risk of malnutrition (MNA-sf). Overall, all patients had videofluoroscopic signs of impaired safety of swallow (ISS) with delayed oropharyngeal swallow response (OSR). After sensory stimulation, prevalence of ISS decreased to 68.42 % in both groups (P = 0.019). There were 68.42 % responders in Group A (TRPV1) and 42.11 % in Group B (TSES). Group A responders showed an improvement in the penetration-aspiration scale (PAS, 5.23 ± 2.04 to 3 ± 1.47; P = 0.002), and the same was true for those of Group B (4.63 ± 1.41 to 2.13 ± 0.64; P = 0.007). 10-day sensory stimulation with either therapy improved safety of swallow and OSR in older patients with OD, reducing the severity of OD in a significant subgroup of these patients.

  7. Genital Bowenʼs Disease in a Bulgarian Patient: Complete Remission after Surgical Approach

    Directory of Open Access Journals (Sweden)

    Georgi Tchernev

    2017-07-01

    Full Text Available A 60-year-old male patient presented with complaints of persistent red to a brown-colored plaque on his scrotum, with duration of approximately three years. The patient had been treated with oral and topical antifungals for inguinal tinea for several months and after that with topical corticosteroids for eczema for several more months. None of the regimens achieved any therapeutic effect. The histopathological evaluation revealed the presence of atypical keratinocytes in all layers of the epidermis with the altered epidermal pattern, spread parabasal mitotic activity, without secondary satellites, multiple dyskeratotic cells and multinucleated cells. The diagnosis of an intraepithelial non-invasive squamous cell carcinoma, associated with koilocytic dysplasia and hyperplasia was made, meeting the criteria for Bowen disease. An elliptic surgical excision of the lesion was made, while the defect was closed with single stitches, with excellent therapeutic and aesthetic result. First described by John T. Bowen in 1912, Bowen disease (BD represents a squamous cell carcinoma (SCC in situ with the potential for significant lateral spread. Treatment options include the application of topical 5-flurorouracil cream – useful in non-hairy areas, imiquimod cream or destructive methods such as radiation, curettage, cryotherapy, laser ablation and photodynamic therapy, especially useful in nail bed involvement. Despite the early lesions, surgical excision is the preferred treatment option, regarding the potential malignant transformation risk.

  8. Successful Recanalization of a Complete Lobar Bronchial Stenosis in a Lung Transplant Patient Using a Combined Percutaneous and Bronchoscopic Approach

    International Nuclear Information System (INIS)

    Miraglia, Roberto; Vitulo, Patrizio; Maruzzelli, Luigi; Burgio, Gaetano; Caruso, Settimo; Bertani, Alessandro; Callari, Adriana; Luca, Angelo

    2016-01-01

    Airway stenosis is a major complication after lung transplantation that is usually managed with a combination of interventional endoscopic techniques, including endobronchial debridement, balloon dilation, and stent placement. Herein, we report a successful case of recanalization of a complete stenosis of the right middle lobe bronchus in a lung transplant patient, by using a combined percutaneous–bronchoscopic approach after the failure of endobronchial debridement

  9. Successful Recanalization of a Complete Lobar Bronchial Stenosis in a Lung Transplant Patient Using a Combined Percutaneous and Bronchoscopic Approach

    Energy Technology Data Exchange (ETDEWEB)

    Miraglia, Roberto, E-mail: rmiraglia@ismett.edu [Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Radiology Service, Department of Diagnostic and Therapeutic Services (Italy); Vitulo, Patrizio, E-mail: pvitulo@ismett.edu [Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Pulmonology Unit, Department for the Treatment and Study of Cardiothoracic Diseases and Cardiothoracic Transplantation (Italy); Maruzzelli, Luigi, E-mail: lmaruzzelli@ismett.edu [Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Radiology Service, Department of Diagnostic and Therapeutic Services (Italy); Burgio, Gaetano, E-mail: gburgio@ismett.edu [Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Operating Room Service, Department of Anesthesia and Intensive Care (Italy); Caruso, Settimo, E-mail: secaruso@ismett.edu [Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Radiology Service, Department of Diagnostic and Therapeutic Services (Italy); Bertani, Alessandro, E-mail: abertani@ismett.edu [Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Thoracic Surgery and Lung Transplantation Unit, Department for the Treatment and Study of Cardiothoracic Diseases and Cardiothoracic Transplantation (Italy); Callari, Adriana, E-mail: acallari@ismett.edu [Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Pulmonology Unit, Department for the Treatment and Study of Cardiothoracic Diseases and Cardiothoracic Transplantation (Italy); Luca, Angelo, E-mail: aluca@ismett.edu [Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Radiology Service, Department of Diagnostic and Therapeutic Services (Italy)

    2016-03-15

    Airway stenosis is a major complication after lung transplantation that is usually managed with a combination of interventional endoscopic techniques, including endobronchial debridement, balloon dilation, and stent placement. Herein, we report a successful case of recanalization of a complete stenosis of the right middle lobe bronchus in a lung transplant patient, by using a combined percutaneous–bronchoscopic approach after the failure of endobronchial debridement.

  10. Residual symptoms in patients with partial versus complete remission of a major depressive disorder episode: patterns of painful physical symptoms in depression

    Directory of Open Access Journals (Sweden)

    Harada E

    2016-06-01

    Full Text Available Eiji Harada,1 Yoichi Satoi,2 Toshiaki Kikuchi,3 Koichiro Watanabe,3 Levent Alev,1 Masaru Mimura4 1Medical Science, Medicines Development Unit-Japan, 2Statistical Science, Medicines Development Unit-Japan, Eli Lilly Japan K.K., Kobe, Hyogo, 3Department of Neuropsychiatry, Kyorin University School of Medicine, 4Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan Objective: The patterns of residual painful physical symptoms (PPS and emotional symptoms among patients with partial remission (PR or complete remission (CR of a major depressive disorder (MDD episode were compared. Methods: This is a multicenter, cross-sectional, observational study. Patients who had originally been diagnosed with MDD, were treated with an antidepressant for 12 weeks for that episode, and achieved either PR or CR at study entry were enrolled in the study. Using the 17-item Hamilton Rating Scale for Depression (HAM-D17, PR was defined as a score of ≥8 and ≤18 and CR as a score of ≤7. Residual symptoms were assessed using the Brief Pain Inventory-Short Form (BPI-SF and the HAM-D17.Results: A total of 323 patients (CR =158, PR =165 were included in the study. Patients in the PR group had a higher mean (standard deviation score in the HAM-D17 than those in the CR group (11.8 [3.1] and 4.4 [2.0], respectively. BPI-SF results showed that “at least moderate PPS” (score ≥3 on BPI-SF question 5 was significantly more prevalent among patients with PR than those with CR (37.0% vs 16.5%, respectively; odds ratio =3.04; P<0.001. Presence of pain (any severity was also more prevalent among patients with PR than those with CR (54.5% vs 35.4%, respectively. The HAM-D17 results for individual items indicated that impaired work and activities, depressed mood, psychological and somatic anxiety, and general somatic symptoms were observed in at least 75% of patients with PR.Conclusion: PR was associated with a higher prevalence of at least moderate PPS

  11. Physiological adaptation after a 12-week physical activity program for patients with Prader-Willi syndrome: two case reports.

    Science.gov (United States)

    Amaro, Alexandre Slowetzky; Teixeira, Maria Cristina Triguero Veloz; de Mesquita, Maria Luiza Guedes; Rodrigues, Graciele Massoli; Rubin, Daniela Andrea; Carreiro, Luiz Renato Rodrigues

    2016-06-23

    Physical activity programs are a powerful tool against several diseases including obesity and their comorbidities. Prader-Willi syndrome is the most common genetic disease associated with obesity, and brings with it behavioral and emotional problems that need complex management. Research into the effect of physical activity programs on Prader-Willi syndrome is limited and it is frequently argued that if a physical activity program is too complex, the participants are more likely to drop out. Therefore, in this study, we assessed the physiological adaptation effect of a physical activity program with increasing complexity and load, in a boy and a girl with Prader-Willi syndrome by assessing changes in lipid profile, body composition, and physical fitness parameters. Case 1 was an 11-year-old girl, mixed race (brown), with an intelligence quotient of 68, 52.0 % body fat, and a body mass index of 45.3 kg/m(2). The Prader-Willi syndrome diagnosis was made when she was 5-years old and was found to be due to an imprinting genomic defect. Case 2 was a 14-year-old boy, mixed race (brown), with an intelligence quotient of 74, 48.8 % body fat, and a body mass index of 37.3 kg/m(2). The diagnosis was made when he was 10-years old and was found to be caused by gene deletion. Both participants presented physical characteristics and behavior problems typical of Prader-Willi syndrome. Case 2 presented high blood pressure, high cholesterol and sleep apnea and had to use continuous positive airway pressure to sleep. Both participants were assessed for 12 weeks (three times a week) using a physical activity program designed to improve strength and muscle hypertrophy. The work load was progressively adjusted as necessary and new exercises were added to the program. Prior to the program, the participants' parents received instructions about managing problem behavior and advice about nutrition. After physical activity program several health markers assessed by biological tests and

  12. Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study.

    Science.gov (United States)

    Marcus, Ronald N; Owen, Randall; Manos, George; Mankoski, Raymond; Kamen, Lisa; McQuade, Robert D; Carson, William H; Corey-Lisle, Patricia K; Aman, Michael G

    2011-06-01

    To report the long-term efficacy of aripiprazole in the treatment of irritability in children and adolescents (ages 6-17 years) with autistic disorder. This was a 52-week, open-label, flexible-dose (2-15 mg/day) study of aripiprazole for the treatment of children and adolescents with irritability associated with autistic disorder. Eligible subjects were enrolled from two 8-week randomized trials or were enrolled as de novo subjects. "Prior aripiprazole" subjects had received treatment with aripiprazole for 8 weeks before entering this study. Evaluation of efficacy, a secondary objective after evaluation of safety and tolerability in this study, was conducted using the caregiver-rated Aberrant Behavior Checklist-Irritability subscale and the clinician-rated Clinical Global Impression-Improvement score. Three hundred thirty subjects received treatment (de novo, n = 86; prior aripiprazole, n = 174; prior placebo, n = 70) and 199 subjects (60.3%) completed 52 weeks of treatment. At their last study visit, 38.2% of subjects were receiving concomitant central nervous system medications (commonly antidepressants, 13.4%; psychostimulants, 11.5%; antiepileptics, 5.9%). At week 52 (observed cases data set), the mean change from baseline in Aberrant Behavior Checklist Irritability subscale scores was -8.0 in de novo subjects and -6.1 in prior placebo subjects; prior aripiprazole subjects maintained symptom improvement that was achieved with treatment in the prior study. At endpoint, the majority of subjects had a Clinical Global Impressions-Improvement score of 2 (much improved) or 1 (very much improved). Aripiprazole reduced symptoms of irritability associated with autistic disorder in pediatric subjects ages 6-17 years who were studied for up to 1 year.

  13. Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant–Associated Anaplastic Large-Cell Lymphoma

    Science.gov (United States)

    Clemens, Mark W.; Medeiros, L. Jeffrey; Butler, Charles E.; Hunt, Kelly K.; Fanale, Michelle A.; Horwitz, Steven; Weisenburger, Dennis D.; Liu, Jun; Morgan, Elizabeth A.; Kanagal-Shamanna, Rashmi; Parkash, Vinita; Ning, Jing; Sohani, Aliyah R.; Ferry, Judith A.; Mehta-Shah, Neha; Dogan, Ahmed; Liu, Hui; Thormann, Nora; Di Napoli, Arianna; Lade, Stephen; Piccolini, Jorge; Reyes, Ruben; Williams, Travis; McCarthy, Colleen M.; Hanson, Summer E.; Nastoupil, Loretta J.; Gaur, Rakesh; Oki, Yasuhiro; Young, Ken H.

    2016-01-01

    Purpose Breast implant–associated anaplastic large-cell lymphoma (BI-ALCL) is a rare type of T-cell lymphoma that arises around breast implants. The optimal management of this disease has not been established. The goal of this study is to evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach. Patients and Methods In this study, we applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BI-ALCL, including 50 previously reported in the literature and 37 unreported. A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention. Results The median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (P = .03). Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (P = .022) and EFS (P = .014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy. Conclusion Surgical management with complete surgical excision is essential to achieve optimal EFS in patients with BI-ALCL. PMID:26628470

  14. Improvement of balance after audio-biofeedback A 6-week intervention study in patients with progressive supranuclear palsy

    NARCIS (Netherlands)

    Nicolai, S.; Mirelman, A.; Herman, T.; Zijlstra, A.; Mancini, M.; Becker, C.; Lindeman, U.; Berg, D.; Maetzler, W.

    Progressive supranuclear palsy (PSP) is a neurodegenerative disease with no sufficient treatment options to date. The most devastating symptom is the loss of balance with consecutive falls Based on the observation that postural control improved in patients with vestibular dysfunction after

  15. Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure

    DEFF Research Database (Denmark)

    O'Keefe, Stephen J D; Jeppesen, Palle B; Gilroy, Richard

    2013-01-01

    Although home parenteral nutrition (PN) can save the lives of patients with massive bowel loss that results in short-bowel syndrome and intestinal failure, quality of life is impaired by PN and its complications. We examined the 12-month tolerability and efficacy of teduglutide to reduce PN depen...

  16. Prevalence of delirium in advanced cancer patients in home care and hospice and outcomes after 1 week of palliative care.

    Science.gov (United States)

    Mercadante, Sebastiano; Masedu, Francesco; Balzani, Isabella; De Giovanni, Daniela; Montanari, Luigi; Pittureri, Cristina; Bertè, Raffaella; Russo, Domenico; Ursini, Laura; Marinangeli, Franco; Aielli, Federica

    2018-03-01

    The aim of this study was to assess the prevalence of delirium in advanced cancer patients admitted to different palliative care services in Italy and possible related factors. The secondary outcome was to assess the changes of delirium after 1 week of palliative care. A consecutive sample of patients was screened for delirium in period of 1 year in seven palliative care services. General data, including primary tumor, age, gender, concomitant disease, palliative prognostic score (PaP), and Karnofsky status, were collected. Possible causes or factors associated with delirium were looked for. The Edmonton Symptom Assessment Scale was used to assess physical and psychological symptoms and the Memorial Delirium Assessment Scale (MDAS) to assess the cognitive status of patients, at admission (T0) and 1 week after palliative care (T7). Of 848 patients screened, 263 patients were evaluated. Sixty-six patients had only the initial evaluation. The mean Karnofsky status was 34.1 (SD = 6.69); the mean PaP score at admission was 6.9 (SD = 3.97). The mean duration of palliative care assistance, equivalent to survival, was 38.4 days (SD = 48, range 2-220). The mean MDAS values at admission and after 1 week of palliative care were 6.9 (SD = 6.71) and 8.8 (SD = 8.26), respectively. One hundred ten patients (41.8%) and 167 patients (67.3%) had MDAS values ≥ 7 at admission and after 1 week of palliative care, respectively. Age, dehydration, cachexia, chemotherapy in the last three months, and intensity of drowsiness and dyspnea were independently associated with a MDAS > 7. A worsening of drowsiness, the use of opioids, and the use of corticosteroids were independently associated with changes of MDAS from T0 to T7. Although the prevalence of delirium seems to be similar to that reported in other acute settings, delirium tended to worsen or poorly responded to a palliative care treatment. Some clinical factors were independently associated with delirium. This

  17. Uncommon Asymptomatic Unilateral Complete Duplicated Collecting System and Giant Ectopic Ureterocele in Middle-Age Patient

    Directory of Open Access Journals (Sweden)

    Halil Serin

    2014-02-01

    Full Text Available Ureterocele is a common pediatric urologic problem, but has been reported seldom in adults. Most duplex system ureteroceles existent as urinary tract infections at an early age, with adult presentation being uncommon. Urinary stasis in the dilated distal ureter often lends to urinary infection and stone formation; precluding the most common offering symptoms of dysuria, urgency, and recurrent urinary tract infections. Ižn duplex system ureteroceles to poorly or non-functioning moieties, heminephroureterectomy is an definite solution. We present a case of rarely middle-age asymptomatic obstructive giant ureterocele. We intended to emphasize that patient with obstructive, giant, ectopic ureterocele and duplicated collecting system may have asymptomatic course.

  18. Long-Term Pain Treatment Did Not Improve Sleep in Nursing Home Patients with Comorbid Dementia and Depression: A 13-Week Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Kjersti M. Blytt

    2018-02-01

    Full Text Available Objective: Previous research indicates that pain treatment may improve sleep among nursing home patients. We aimed to investigate the long-term effect of pain treatment on 24-h sleep patterns in patients with comorbid depression and dementia.Design: A 13-week, multicenter, parallel-group, double-blind, placebo-controlled randomized clinical trial conducted between August 2014 and September 2016.Setting: Long-term patients from 47 nursing homes in Norway.Participants: We included 106 patients with comorbid dementia and depression according to the Mini Mental Status Examination (MMSE and the Cornell Scale for Depression in Dementia (CSDD.Intervention: Patients who were not using analgesics were randomized to receive either paracetamol (3 g/day or placebo tablets. Those who already received pain treatment were randomized to buprenorphine transdermal system (maximum 10 μg/h/7 days or placebo transdermal patches.Measurements: Sleep was assessed continuously for 7 days by actigraphy, at baseline and in week 13. Total sleep time (TST, sleep efficiency (SE, sleep onset latency (SOL, wake after sleep onset (WASO, early morning awakening (EMA, and number of wake bouts (NoW were evaluated. In addition, daytime total sleep time (DTS was estimated. Pain was assessed with Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale (MOBID-2.Results: The linear mixed model analyses for TST, SE, SOL, WASO, EMA, NoW and DTS showed no statistically significant differences between patients who received active pain treatment and those who received placebo. Post hoc subgroup analyses showed that there were no statistically significant differences between active treatment and placebo from baseline to week 13 in patients who were in pain (MOBID-2 ≥ 3 at baseline, or in patients who had poor sleep (defined as SE < 85% at baseline. Patients who received active buprenorphine showed an increase in TST and SE compared to those who received active paracetamol

  19. Durability of Stavudine, Lamivudine and Nevirapine among Advanced HIV-1 Infected Patients with/without Prior Co-administration of Rifampicin: A 144-week Prospective Study

    Directory of Open Access Journals (Sweden)

    Prasithisirikul Wisit

    2008-10-01

    Full Text Available Abstract Background To date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings. Methods A prospective cohort study was conducted among 140 antiretroviral-naïve patients who were enrolled to initiate d4T, 3TC and NVP between November 2004 and March 2005. The objectives were to determine immunological and virological responses after 144 weeks of antiretroviral therapy. Seventy patients with tuberculosis also received rifampicin during the early period of antiviral treatment (TB group. Results Of all, median (IQR baseline CD4 cell count was 31 (14–79 cells/mm3; median (IQR baseline HIV-1 RNA was 433,500 (169,000–750,000 copies/mL. The average body weight was 55 kilograms. By intention-to-treat analysis at 144 weeks, the overall percentage of patients who achieved plasma HIV-1 RNA P = 0.731. Eight (5.8% patients discontinued d4T due to neuropathy and/or symptomatic lactic acidosis. Conclusion The overall durability and efficacy of antiviral response of d4T, 3TC and NVP are satisfied and they are not different between HIV-1 infected patients with and without co-administration of rifampicin due to tuberculosis. However, stavudine-related adverse effects are concerns. Trial registration ClinicalTrials.gov Identifier NCT00703898

  20. Continuous infusion versus daily injections of growth hormone (GH) for 4 weeks in GH-deficient patients

    DEFF Research Database (Denmark)

    Laursen, Torben; Jørgensen, Jens Otto Lunde; Jakobsen, Grethe

    1995-01-01

    effects with constant and pulsatile GH delivery. This study was carried out to compare the metabolic effects of longer term continuous infusion vs. daily injections of GH. Thirteen GH-deficient patients were studied in a cross-over design. The patients were randomized to receive GH as a continuous sc...... infusion by means of a portable pump for 1 month and as daily sc injections (at 1900 h) for another month. An average daily GH dosage (+/- SEM) of 3.15 +/- 0.27 IU was administered during both periods. Steady state 24-h profiles of GH, IGF-I, IGF-binding proteins (IGFBPs), insulin, glucose, lipid.......35 (infusion); P infusion induced higher nighttime than daytime GH levels (P = 0.01), indicating a diurnal variation in the absorption or clearance of GH. Serum IGF-I levels (micrograms per L) were slightly higher (P infusion [312...

  1. Effects of chair yoga therapy on physical fitness in patients with psychiatric disorders: A 12-week single-blind randomized controlled trial.

    Science.gov (United States)

    Ikai, Saeko; Uchida, Hiroyuki; Mizuno, Yuya; Tani, Hideaki; Nagaoka, Maki; Tsunoda, Kenichi; Mimura, Masaru; Suzuki, Takefumi

    2017-11-01

    Since falls may lead to fractures and have serious, potentially fatal outcomes, prevention of falls is an urgent public health issue. We examined the effects of chair yoga therapy on physical fitness among psychiatric patients in order to reduce the risk of falls, which has not been previously reported in the literature. In this 12-week single-blind randomized controlled trial with a 6-week follow-up, inpatients with mixed psychiatric diagnoses were randomly assigned to either chair yoga therapy in addition to ongoing treatment, or treatment-as-usual. Chair yoga therapy was conducted as twice-weekly 20-min sessions over 12 weeks. Assessments included anteflexion in sitting, degree of muscle strength, and Modified Falls Efficacy Scale (MFES) as well as QOL, psychopathology and functioning. Fifty-six inpatients participated in this study (36 men; mean ± SD age, 55.3 ± 13.7 years; schizophrenia 87.5%). In the chair yoga group, significant improvements were observed in flexibility, hand-grip, lower limb muscle endurance, and MFES at week 12 (mean ± SD: 55.1 ± 16.6 to 67.2 ± 14.0 cm, 23.6 ± 10.6 to 26.8 ± 9.7 kg, 4.9 ± 4.0 to 7.0 ± 3.9 kg, and 114.9 ± 29.2 to 134.1 ± 11.6, respectively). Additionally, these improvements were observable six weeks after the intervention was over. The QOL-VAS improved in the intervention group while no differences were noted in psychopathology and functioning between the groups. The intervention appeared to be highly tolerable without any notable adverse effects. The results indicated sustainable effects of 20-min, 12-week, 24-session chair yoga therapy on physical fitness. Chair yoga therapy may contribute to reduce the risk of falls and their unwanted consequences in psychiatric patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Phase I dose-escalation study of vinflunine hard capsules administered twice a day for 2 consecutive days every week in patients with advanced/metastatic solid tumors.

    Science.gov (United States)

    Calvo, E; Vermorken, J B; Hiret, S; Rodon, J; Cortes, J; Senellart, H; Van den Brande, J; Dyck, J; Pétain, A; Ferre, P; Bennouna, J

    2012-06-01

    Vinflunine is a new microtubule inhibitor of the vinca-alkaloid family. It is marketed in transitional cell carcinoma of urothelial tract as a 20 min infusion given every 3 weeks in Europe. In this phase I study, vinflunine was administered to patients with advanced malignancies as hard capsules given twice a day on days 1-2 every week, with 3 weeks cycles. Serial blood samples were collected during the first cycle for pharmacokinetic investigations. Thirty-six patients (pts) were treated at 6 dose levels 150 (3 pts), 190 (3 pts), 230 (8 pts), 300 mg/day (6 pts) and then 250 (3 pts) and 270 mg/day (13 pts). The Maximal Tolerated Dose (MTD) was reached at 300 mg/day where 2 patients out of 6 experienced a dose limiting toxicity (febrile neutropenia with diarrhea). The lower dose level of 270 mg/day was the recommended dose (RD), the toxicity profile being mainly anaemia, neutropenia, fatigue and constipation. The pharmacokinetic analysis demonstrated the adequacy of the flat-fixed dosing regimen, as no correlation between clearance of vinflunine and body surface area was evidenced. Blood concentrations and exposure increased with dose, and a pharmacokinetic accumulation was observed, which is consistent with the terminal half-life of the compounds. The inter-individual exposure variability at the RD was 35%. Repeated weekly administration of oral vinflunine is feasible and exhibits a moderate inter-individual PK variability. The MTD was achieved at 300 mg/day given for 2 consecutive days. According to the protocol rules, the RD was established at 270 mg/day.

  3. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial.

    Science.gov (United States)

    Nuzzo, Francesco; Morabito, Alessandro; Gravina, Adriano; Di Rella, Francesca; Landi, Gabriella; Pacilio, Carmen; Labonia, Vincenzo; Rossi, Emanuela; De Maio, Ermelinda; Piccirillo, Maria Carmela; D'Aiuto, Giuseppe; Thomas, Renato; Rinaldo, Massimo; Botti, Gerardo; Di Bonito, Maurizio; Di Maio, Massimo; Gallo, Ciro; Perrone, Francesco; de Matteis, Andrea

    2011-02-16

    To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03); patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p < 0.001). Neutropenia and stomatitis were worse in the 3-weekly arm, where two toxic deaths were observed. Overall response rate was 39.1% and 33.3% in 3-weekly and weekly arms; hazard ratio of progression was 1.29 (95% CI: 0.84-1.97) and hazard ratio of death was 1.38 (95% CI: 0.82-2.30) in the weekly arm. In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. ClinicalTrials.gov NCT00540800.

  4. In rape trauma PTSD, patient characteristics indicate which trauma-focused treatment they are most likely to complete.

    Science.gov (United States)

    Keefe, John R; Wiltsey Stirman, Shannon; Cohen, Zachary D; DeRubeis, Robert J; Smith, Brian N; Resick, Patricia A

    2018-04-01

    Dropout rates for effective therapies for posttraumatic stress disorder (PTSD) can be high, especially in practice settings. Although clinicians have intuitions regarding what treatment patients may complete, there are few systematic data to drive those judgments. A multivariable model of dropout risk was constructed with randomized clinical trial data (n = 160) comparing prolonged exposure (PE) and cognitive processing therapy (CPT) for rape-induced PTSD. A two-step bootstrapped variable selection algorithm was applied to identify moderators of dropout as a function of treatment condition. Employing identified moderators in a model, fivefold cross-validation yielded estimates of dropout probability for each patient in each condition. Dropout rates between patients who did and did not receive their model-indicated treatment were compared. Despite equivalent dropout rates across treatments, patients assigned to their model-indicated treatment were significantly less likely to drop out relative to patients who did not (relative risk = 0.49 [95% CI: 0.29-0.82]). Moderators included in the model were: childhood physical abuse, current relationship conflict, anger, and being a racial minority, all of which were associated with higher likelihood of dropout in PE than CPT. Individual differences among patients affect the likelihood they will complete a particular treatment, and clinicians can consider these moderators in treatment planning. In the future, treatment selection models could be used to increase the percentage of patients who will receive a full course of treatment, but replication and extension of such models, and consideration of how best to integrate them into routine practice, are needed. © 2018 Wiley Periodicals, Inc.

  5. Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

    Science.gov (United States)

    Clemens, Mark W; Medeiros, L Jeffrey; Butler, Charles E; Hunt, Kelly K; Fanale, Michelle A; Horwitz, Steven; Weisenburger, Dennis D; Liu, Jun; Morgan, Elizabeth A; Kanagal-Shamanna, Rashmi; Parkash, Vinita; Ning, Jing; Sohani, Aliyah R; Ferry, Judith A; Mehta-Shah, Neha; Dogan, Ahmed; Liu, Hui; Thormann, Nora; Di Napoli, Arianna; DiNapoli, Arianna; Lade, Stephen; Piccolini, Jorge; Reyes, Ruben; Williams, Travis; McCarthy, Colleen M; Hanson, Summer E; Nastoupil, Loretta J; Gaur, Rakesh; Oki, Yasuhiro; Young, Ken H; Miranda, Roberto N

    2016-01-10

    Breast implant-associated anaplastic large-cell lymphoma (BI-ALCL) is a rare type of T-cell lymphoma that arises around breast implants. The optimal management of this disease has not been established. The goal of this study is to evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach. In this study, we applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BI-ALCL, including 50 previously reported in the literature and 37 unreported. A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention. The median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (P = .03). Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (P = .022) and EFS (P = .014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy. Surgical management with complete surgical excision is essential to achieve optimal EFS in patients with BI-ALCL. © 2015 by American Society of Clinical Oncology.

  6. Japanese study of tofogliflozin with type 2 diabetes mellitus patients in an observational study of the elderly (J-STEP/EL): A 12-week interim analysis.

    Science.gov (United States)

    Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Kameda, Hiroyuki; Tamura, Masahiro; Mihara, Hanako; Kaku, Kohei

    2016-09-01

    Sodium-glucose co-transporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, but are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing surveillance of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus and here report the results of a 12-week interim analysis, focusing on adverse drug reactions of special interest. The present prospective observational study included all type 2 diabetes mellitus patients aged ≥65 years who started tofogliflozin during the first 3 months after its launch. Data on demographic and baseline characteristics, clinical course and adverse events were collected. Of 1,535 patients registered, 1,506 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis at 12 weeks. A total of 178 of 1,506 patients (11.82%) had at least one adverse drug reaction to tofogliflozin. The incidence of adverse drug reactions of special interest (polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, skin disorders and hypoglycemia) was 2.19, 2.32, 1.33, 1.13, 1.46 and 0.73%, respectively. No new safety concerns were identified. Among those evaluable for clinical effectiveness, the mean (standard deviation) glycated hemoglobin decreased from 7.65% (1.35%) at baseline to 7.25% (1.16%) at 12 weeks by 0.39% (0.94%; P type 2 diabetes mellitus during the early post-marketing period. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  7. Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study.

    Science.gov (United States)

    Leng, Xiaomei; Li, Zhanguo; Lv, Houshan; Zheng, Yi; Liu, Yi; Dai, Kerong; Yao, Chen; Yan, Xiaoyan; Zeng, Xiaofeng

    2015-07-01

    The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to severe musculoskeletal pain inadequately controlled with nonsteroidal anti-inflammatory drugs, compared with sustained-release tramadol tablets. Eligible patients were randomized (1:1) to receive low-dose 7-day BTDS (5, 10, and 20 μg/h, maximum dosage of 20 μg/h) or sustained-release tramadol tablets (100 mg, maximum dosage of 400 mg/d) over an 8-week double-blind treatment period (3-week titration, 5-week maintenance). The primary endpoint was the difference in the visual analogue scale (VAS) pain scores from baseline to treatment completion. Noninferiority was assumed if the treatment difference on the VAS scale was within ±1.5 cm, this threshold indicating a clinically meaningful result. ClinicalTrials.gov identifier: NCT01476774. Two hundred eighty patients were randomized to BTDS (n=141) or to tramadol (n=139). Both treatments were associated with a significant reduction in pain by the end of the treatment. The least squares mean difference of the change from baseline in VAS scores between the BTDS and tramadol groups were 0.45 (95% confidence interval, -0.02 to 0.91), which was within the ±1.5 cm predefined threshold, indicating that the effectiveness of BTDS was not inferior to the effectiveness of sustained-release tramadol tablets. The incidence of adverse events was comparable between the 2 treatment groups. Our results suggest that BTDS is a good therapeutic option for patients experiencing chronic musculoskeletal pain of moderate to severe intensity that is insufficiently controlled by nonsteroidal anti-inflammatory drugs.

  8. The Effect of 8 Weeks of the Selected Combined Exercises on Balance and Pain of Patients Suffering from Arthritis of Knee

    Directory of Open Access Journals (Sweden)

    Elnaz Karimi

    2016-11-01

    Full Text Available Osteoarthritis is considered as the most common joint disease of humans and one of the most common causes of chronic disability among elderly people in the developed countries. The main objective of the present research was to determine the impact of 8 weeks of the combined exercises on the balance and the amount of pain of patients with knee osteoarthritis. 15 patients with knee arthritis were selected purposefully and in form of convenience and they participated in this research. The patients implemented the Training Protocol of walking in water and land and the knee locking and the front thigh exercises for 8 weeks. Dynamic balance (Y test and pain (McGill questionnaire of patients with knee arthritis were measured and evaluated before and after eight weeks of combined exercises. The data were analyzed by use of the t-dependent (P˂0.05. In the dynamic balance of patients with knee arthritis, there was significant difference regarding the anterior side between before-exercises (39.9 7.2 and after-exercises (50.76.8, regarding the internal posterior side between before-exercises (28.8 9.2 and after-exercises (38.0 8.7, regarding the external posterior direction between before-exercises (37.5 7.2 and after-exercises (44.4 7.4. (P˂0.05. Regarding sense perception of pain by patients, there was significant difference between before-exercises (2.2 0.6 and after-exercises (1.8 0.5, regarding the emotional perception of pain by patients between beforeexercises (1.5 0.3 and after-exercises (1.2 0.3 and on perceiving variety of pain by patients between before- (2.10.8 and after-practices (1.8 0.7 (P˂0.05. From the findings of the present research we can conclude that the hydrotherapy exercises combined with exercises on land can cause to improve the dynamic balance and the pain of patients with knee arthritis; therefore we can recommend it as a modality for these patients.

  9. An investigation of completion times on the Screener and Opioid Assessment for Patients with Pain – revised (SOAPP-R

    Directory of Open Access Journals (Sweden)

    Finkelman MD

    2016-12-01

    Full Text Available Matthew D Finkelman,1 Ronald J Kulich,2,3 Stephen F Butler,4 William C Jackson,3 Franklin D Friedman,5 Niels Smits,6 Scott G Weiner7 1Department of Public Health and Community Service, Tufts University School of Dental Medicine, Boston, MA, USA; 2Craniofacial Pain and Headache Center, Tufts University School of Dental Medicine, Boston, MA, USA; 3Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, 4Inflexxion Inc, Newton, MA, USA; 5Department of Emergency Medicine, Tufts Medical Center, Boston, MA, USA; 6Department of Methods and Statistics, Research Institute of Child Development and Education, University of Amsterdam, Amsterdam, the Netherlands; 7Department of Emergency Medicine, Brigham and Women’s Hospital, Boston, MA, USA Background: Respondents’ scores to the Screener and Opioid Assessment for Patients with Pain – revised (SOAPP-R have been shown to be predictive of aberrant drug-related behavior (ADB. However, research is lacking on whether an individual’s completion time (the amount of time that he/she takes to finish the screener has utility in predicting ADB, despite the fact that response speed has been useful in predicting behavior in other fields. The purpose of this study was to evaluate the degree to which SOAPP-R completion time is predictive of ADB.Materials and methods: This retrospective study analyzed completion-time data from 82 adult emergency department patients who completed the SOAPP-R on a tablet computer. The utility of SOAPP-R completion times in predicting ADB was assessed via logistic regression and the area under the curve (AUC statistic. An external measure of ADB using Prescription Drug Monitoring Program data defined ADB to have occurred in individuals with at least four opioid prescriptions and at least four prescribers in 12 months.Results: Although there was a slight trend for individuals with greater completion times to have greater odds of ADB (odds ratio 1

  10. Complete resection of the primary lesion improves survival of certain patients with stage IV non-small cell lung cancer.

    Science.gov (United States)

    Chikaishi, Yasuhiro; Shinohara, Shinji; Kuwata, Taiji; Takenaka, Masaru; Oka, Soichi; Hirai, Ayako; Yoneda, Kazue; Kuroda, Kouji; Imanishi, Naoko; Ichiki, Yoshinobu; Tanaka, Fumihiro

    2017-12-01

    The standard treatment for patients with stage IV non-small cell lung cancer (NSCLC) is systemic chemotherapy. However, certain patients, such as those with oligometastasis or M1a disease undergo resection of the primary lesion. We conducted a retrospective review of the records of 1,471 consecutive patients with NSCLC who underwent resection of the primary lesion for between June 2005 and May 2016. The present study included 38 patients with stage IV NSCLC who underwent complete resection of the primary lesion as first-line treatment. The median follow-up duration for the 38 patients (27 men) was 17.7 months (range, 1-82.3 months). The T factors were T1/T2/T3/T4 in 4/16/12/6 patients, respectively. The N factors were N0/N1/N2/N3 in 16/8/12/2 patients, respectively. The M factors were M1a/M1b/M1c in 19/13/6 patients, respectively. Of the 19 M1a patients, 11 were classified as cM0. We introduced the novel classification M-better/M-worse. M-better includes cM0 patients and M1b and M1c patients in whom all lesions have been locally controlled. M-worse includes cM1a patients and M1b and M1c patients in whom lesions cannot be locally controlled. The new M-better/M-worse statuses were 24/14 patients, respectively. The histology of NSCLC was adenocarcinoma/squamous cell carcinoma/others in 30/5/3 patients, respectively. The 5-year overall survival rate was 29%, and the median survival time was 725 days. Squamous cell carcinoma and M-worse were significant factors predicting poor outcomes (P=0.0017, P=0.0007, respectively). Even for stage IV NSCLC patients, resection of the primary lesion may be beneficial, especially for those with M-better status and those not diagnosed with squamous-cell carcinoma (SCC).

  11. Clinical diagnosis of partial or complete anterior cruciate ligament tears using patients' history elements and physical examination tests.

    Science.gov (United States)

    Décary, Simon; Fallaha, Michel; Belzile, Sylvain; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Feldman, Debbie; Sylvestre, Marie-Pierre; Vendittoli, Pascal-André; Desmeules, François

    2018-01-01

    To assess the diagnostic validity of clusters combining history elements and physical examination tests to diagnose partial or complete anterior cruciate ligament (ACL) tears. Prospective diagnostic study. Orthopaedic clinics (n = 2), family medicine clinics (n = 2) and community-dwelling. Consecutive patients with a knee complaint (n = 279) and consulting one of the participating orthopaedic surgeons (n = 3) or sport medicine physicians (n = 2). Not applicable. History elements and physical examination tests performed independently were compared to the reference standard: an expert physicians' composite diagnosis including history elements, physical tests and confirmatory magnetic resonance imaging. Penalized logistic regression (LASSO) was used to identify history elements and physical examination tests associated with the diagnosis of ACL tear and recursive partitioning was used to develop diagnostic clusters. Diagnostic accuracy measures including sensitivity (Se), specificity (Sp), predictive values and positive and negative likelihood ratios (LR+/-) with associated 95% confidence intervals (CI) were calculated. Forty-three individuals received a diagnosis of partial or complete ACL tear (15.4% of total cohort). The Lachman test alone was able to diagnose partial or complete ACL tears (LR+: 38.4; 95%CI: 16.0-92.5). Combining a history of trauma during a pivot with a "popping" sensation also reached a high diagnostic validity for partial or complete tears (LR+: 9.8; 95%CI: 5.6-17.3). Combining a history of trauma during a pivot, immediate effusion after trauma and a positive Lachman test was able to identify individuals with a complete ACL tear (LR+: 17.5; 95%CI: 9.8-31.5). Finally, combining a negative history of pivot or a negative popping sensation during trauma with a negative Lachman or pivot shift test was able to exclude both partial or complete ACL tears (LR-: 0.08; 95%CI: 0.03-0.24). Diagnostic clusters combining history elements and physical

  12. Complete remission of liver metastasis in a lung cancer patient with epidermal growth factor mutation achieved with Icotinib.

    Science.gov (United States)

    Zhu, Zhouyu; Chai, Ying

    2016-11-01

    A 65-year-old Chinese male was referred to our hospital for epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC). Aggressive combined therapy with surgical resection of the right upper lung lesion and chemotherapy was performed. One month later, continued Icotinib treatment was used as magnetic resonance imaging revealed liver metastasis (LM). Interestingly, complete remission of the patient's LM lesions was achieved in six months. To our knowledge, this is the first report documenting a successful case of an NSCLC patient with LM treated with Icotinib after receiving a radical resection for pulmonary carcinoma. Our experience could provide a treatment strategy for patients with similar disease. © 2016 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

  13. A Complete Response Case in a Patient with Multiple Lung Metastases of Rectal Cancer Treated with Bevacizumab plus XELIRI Therapy

    Directory of Open Access Journals (Sweden)

    Hiroki Hashida

    2017-01-01

    Full Text Available It has been reported that many patients with lung metastasis of colorectal cancer (CRC underwent chemotherapy with fluorouracil, folinic acid, oxaliplatin, irinotecan, or capecitabine. There is a small number of reports about the capecitabine and irinotecan (XELIRI plus bevacizumab (BV therapy for patients with metastatic CRC in Japan. We report a case of successful BV+XELIRI therapy for rectal cancer with multiple lung metastases as first-line chemotherapy. A 53-year-old female presented with advanced rectal cancer and metastatic lung tumors. Following surgery, the patient was treated with XELIRI+BV. After 6 courses, a computed tomography scan showed complete response of the lung metastases. No recurrence has occurred for 3 years after chemotherapy was stopped.

  14. Demonstration of safety in Alzheimer's patients for intervention with an anti-hypertensive drug Nilvadipine: results from a 6-week open label study.

    LENUS (Irish Health Repository)

    Kennelly, S P

    2012-02-01

    BACKGROUND: Nilvadipine may lower rates of conversion from mild-cognitive impairment to Alzheimer\\'s disease (AD), in hypertensive patients. However, it remains to be determined whether treatment with nilvadipine is safe in AD patients, given the higher incidence of orthostatic hypotension (OH) in this population, who may be more likely to suffer from symptoms associated with the further exaggeration of a drop in BP. OBJECTIVE: The aim of this study was to investigate the safety and tolerability of nilvadipine in AD patients. METHODS: AD patients in the intervention group (n = 56) received nilvadipine 8 mg daily over 6-weeks, compared to the control group (n = 30) who received no intervention. Differences in systolic (SBP) and diastolic (DBP) blood pressure, before and after intervention, was assessed using automated sphygmomanometer readings and ambulatory BP monitors (ABP), and change in OH using a finometer. Reporting of adverse events was monitored throughout the study. RESULTS: There was a significant reduction in the SBP of treated patients compared to non-treated patients but no significant change in DBP. Individuals with higher initial blood pressure (BP) had greater reduction in BP but individuals with normal BP did not experience much change in their BP. While OH was present in 84% of the patients, there was no further drop in BP recorded on active stand studies. There were no significant differences in adverse event reporting between groups. CONCLUSION: Nilvadipine was well tolerated by patients with AD. This study supports further investigation of its efficacy as a potential treatment for AD.

  15. Efficacy and safety of the long-acting β2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Ichinose M

    2015-08-01

    Full Text Available Masakazu Ichinose,1 Ayako Takizawa,2 Toshiyasu Izumoto,2 Yusuke Tadayasu,2 Alan L Hamilton,3 Christina Kunz,4 Yoshinosuke Fukuchi51Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; 2Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan; 3Boehringer Ingelheim, Burlington, Ontario, Canada; 4Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany; 5Juntendo University School of Medicine, Tokyo, JapanBackground: Olodaterol is a novel long-acting β2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.Objective: This randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD.Methods: All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat® Soft Mist™ inhaler. The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV1 after 4 weeks of olodaterol treatment. Secondary end points included trough FEV1 after 1 week and 2 weeks of treatment, FEV1 area under the curve from 0 hour to 3 hours (AUC0–3, peak FEV1 from 0 hour to 3 hours (peak FEV1, and corresponding forced vital capacity (FVC responses. Rescue medication use, COPD symptoms, physician global evaluation, pharmacokinetics, and safety were also assessed.Results: A total of 328 patients with COPD were randomized to receive treatment. All olodaterol doses assessed in the study showed statistically significant increases in trough FEV1 compared to placebo at Day 29 (P<0.0001. Mean increases in peak FEV1 and FEV1 AUC0–3 compared to placebo were also significant (P<0.0001. A clear dose–response relationship was observed across all treatment groups. FVC responses (trough

  16. The Effectiveness of a 6-Week Intervention Program Aimed at Modifying Running Style in Patients With Chronic Exertional Compartment Syndrome: Results From a Series of Case Studies.

    Science.gov (United States)

    Helmhout, Pieter H; Diebal, Angela R; van der Kaaden, Lisanne; Harts, Chris C; Beutler, Anthony; Zimmermann, Wes O

    2015-03-01

    Previous studies have reported on the promising effects of changing running style in patients with chronic exertional compartment syndrome (CECS) using a 6-week training program aimed at adopting a forefoot strike technique. This study expands that work by comparing a 6-week in-house, center-based run training program with a less extensive, supervised, home-based run training program (50% home training). An alteration in running technique will lead to improvements in CECS complaints and running performance, with the less supervised program producing less dramatic results. Cohort study; Level of evidence, 3. Nineteen patients with CECS were prospectively enrolled. Postrunning intracompartmental pressure (ICP), run performance, and self-reported questionnaires were taken for all patients at baseline and after 6 weeks of running intervention. Questionnaires were also taken from 14 patients (7 center-based, 6 home-based) 4 months posttreatment. Significant improvement between preintervention and postintervention rates was found for running distance (43%), ICP values (36%), and scores on the questionnaires Single Assessment Numeric Evaluation (SANE; 36%), Lower Leg Outcome Survey (LLOS; 18%), and Patient Specific Complaints (PSC; 60%). The mean posttreatment score on the Global Rating of Change (GROC) was between +4 and +5 ("somewhat better" to "moderately better"). In 14 participants (74%), no elevation of pain was reported posttreatment, compared with 3 participants (16%) at baseline; in all these cases, the running test was aborted because of a lack of cardiorespiratory fitness. Self-reported scores continued to improve 4 months after the end of the intervention program, with mean improvement rates of 48% (SANE), 26% (LLOS), and 81% (PSC). The mean GROC score improved to +6 points ("a great deal better"). In 19 patients diagnosed with CECS, a 6-week forefoot running intervention performed in both a center-based and home-based training setting led to decreased

  17. Cognitive and Behavioral Skills Exercises Completed by Patients with Major Depression During Smartphone Cognitive Behavioral Therapy: Secondary Analysis of a Randomized Controlled Trial

    Science.gov (United States)

    Horikoshi, Masaru; Fujita, Hirokazu; Tsujino, Naohisa; Jinnin, Ran; Kako, Yuki; Ogawa, Sei; Sato, Hirotoshi; Kitagawa, Nobuki; Shinagawa, Yoshihiro; Ikeda, Yoshio; Imai, Hissei; Tajika, Aran; Ogawa, Yusuke; Akechi, Tatsuo; Yamada, Mitsuhiko; Shimodera, Shinji; Watanabe, Norio; Inagaki, Masatoshi; Hasegawa, Akio

    2018-01-01

    Background A strong and growing body of evidence has demonstrated the effectiveness of cognitive behavioral therapy (CBT), either face-to-face, in person, or as self-help via the Internet, for depression. However, CBT is a complex intervention consisting of several putatively effective components, and how each component may or may not contribute to the overall effectiveness of CBT is poorly understood. Objective The aim of this study was to investigate how the users of smartphone CBT use and benefit from various components of the program. Methods This is a secondary analysis from a 9-week, single-blind, randomized controlled trial that has demonstrated the effectiveness of adjunctive use of smartphone CBT (Kokoro-App) over antidepressant pharmacotherapy alone among patients with drug-resistant major depressive disorder (total n=164, standardized mean difference in depression severity at week 9=0.40, J Med Internet Res). Kokoro-App consists of three cognitive behavioral skills of self-monitoring, behavioral activation, and cognitive restructuring, with corresponding worksheets to fill in. All activities of the participants learning each session of the program and completing each worksheet were uploaded onto Kokoro-Web, which each patient could use for self-check. We examined what use characteristics differentiated the more successful users of the CBT app from the less successful ones, split at the median of change in depression severity. Results A total of 81 patients with major depression were allocated to the smartphone CBT. On average, they completed 7.0 (standard deviation [SD] 1.4) out of 8 sessions of the program; it took them 10.8 (SD 4.2) days to complete one session, during which they spent 62 min (SD 96) on the app. There were no statistically significant differences in the number of sessions completed, time spent for the program, or the number of completed self-monitoring worksheets between the beneficiaries and the nonbeneficiaries. However, the former

  18. Cognitive and Behavioral Skills Exercises Completed by Patients with Major Depression During Smartphone Cognitive Behavioral Therapy: Secondary Analysis of a Randomized Controlled Trial.

    Science.gov (United States)

    Furukawa, Toshi A; Horikoshi, Masaru; Fujita, Hirokazu; Tsujino, Naohisa; Jinnin, Ran; Kako, Yuki; Ogawa, Sei; Sato, Hirotoshi; Kitagawa, Nobuki; Shinagawa, Yoshihiro; Ikeda, Yoshio; Imai, Hissei; Tajika, Aran; Ogawa, Yusuke; Akechi, Tatsuo; Yamada, Mitsuhiko; Shimodera, Shinji; Watanabe, Norio; Inagaki, Masatoshi; Hasegawa, Akio

    2018-01-11

    A strong and growing body of evidence has demonstrated the effectiveness of cognitive behavioral therapy (CBT), either face-to-face, in person, or as self-help via the Internet, for depression. However, CBT is a complex intervention consisting of several putatively effective components, and how each component may or may not contribute to the overall effectiveness of CBT is poorly understood. The aim of this study was to investigate how the users of smartphone CBT use and benefit from various components of the program. This is a secondary analysis from a 9-week, single-blind, randomized controlled trial that has demonstrated the effectiveness of adjunctive use of smartphone CBT (Kokoro-App) over antidepressant pharmacotherapy alone among patients with drug-resistant major depressive disorder (total n=164, standardized mean difference in depression severity at week 9=0.40, J Med Internet Res). Kokoro-App consists of three cognitive behavioral skills of self-monitoring, behavioral activation, and cognitive restructuring, with corresponding worksheets to fill in. All activities of the participants learning each session of the program and completing each worksheet were uploaded onto Kokoro-Web, which each patient could use for self-check. We examined what use characteristics differentiated the more successful users of the CBT app from the less successful ones, split at the median of change in depression severity. A total of 81 patients with major depression were allocated to the smartphone CBT. On average, they completed 7.0 (standard deviation [SD] 1.4) out of 8 sessions of the program; it took them 10.8 (SD 4.2) days to complete one session, during which they spent 62 min (SD 96) on the app. There were no statistically significant differences in the number of sessions completed, time spent for the program, or the number of completed self-monitoring worksheets between the beneficiaries and the nonbeneficiaries. However, the former completed more behavioral activation

  19. Effects of vaginal progesterone on pain and uterine contractility in patients with threatened abortion before twelve weeks of pregnancy.

    Science.gov (United States)

    Palagiano, A; Bulletti, C; Pace, M C; DE Ziegler, D; Cicinelli, E; Izzo, A

    2004-12-01

    Fifty women with previous diagnosis of inadequate luteal phase and threatened abortion underwent a prospective, randomized, double-blind study in one medical center carried out with a parallel trial. The primary objective was to establish the effects of vaginal progesterone (Crinone 8%) in reducing both pain and uterine contractions (UCs). The gel with or without (placebo) vaginal progesterone was administered once a day since the diagnosis of threatened abortion and for 5 days. The efficacy on pain symptom amelioration was evaluated by a 5-score intensity gradation, while the UCs were evaluated by ultrasound. The secondary objective of the study was to evaluate the outcome of the pregnancies. The use of progesterone was effective both on pain relief and on the frequency of the UCs that decreased after 5 days of vaginal progesterone administration (P pregnancy and spontaneous abortion in both study groups after 60 days showed that 4 patients of group A and 8 patients of group B miscarried (P threatened abortion benefit from vaginal progesterone by a reduction of UCs and pain. The use of vaginal progesterone improved the outcome of pregnancies complicated by threatened abortion and previous diagnosis of inadequate luteal phase.

  20. The relationship between physical activity level and completion rate of small bowel examination in patients undergoing capsule endoscopy.

    Science.gov (United States)

    Shibuya, Tomoyoshi; Mori, Hiroki; Takeda, Tsutomu; Konishi, Masae; Fukuo, Yuka; Matsumoto, Kenshi; Beppu, Kazuko; Sakamoto, Naoto; Osada, Taro; Nagahara, Akihito; Otaka, Michiro; Ogihara, Tatsuo; Watanabe, Sumio

    2012-01-01

    Capsule endoscopy (CE) allows direct examination of the small bowel in a safe, noninvasive and well-tolerated manner. Nonetheless, experience indicates failure to reach the cecum in 20-30% of patients within the 8 hour battery life. Attempts to improve the completion rate (CR) as defined by reaching the cecum have been unsuccessful. This study was to investigate the relationship between patients' physical activity and CR. Between January 2009 and January 2010, 76 patients (44 men, 32 women; median age 64.5 yr) underwent CE for the diagnosis of small intestinal disorders. Indications for CE were obscure gastrointestinal bleeding/anemia (62 cases), others (14 cases). Patients were divided into an outpatient group (n=23), mild bed rest group (n=35) and strict bed rest group (n=18). For all patients, the average gastric transit time was 65.5 minutes, small bowel transit time was 301.4 minutes and the CR was 86.8%. However, the CR was 100% (23/23) in the outpatient group, an 85.7% (30/35) in the mild bed rest group, and 72.2% (13/18) in the strict bed rest group. The CR increased with physical activity of patients by Cochran-Armitage Trend Test (p=0.009). In multivariate logistic regression analyses, low physical activity was a significant risk factor for failure to reach the cecum during CE examination; adjusted OR: 3.39, 95% CI: 1.01-11.42 (p=0.048). Our observations suggested that increasing physical activity would increase the likelihood of a complete bowel examination by CE. Further, for CE, inconvenient bowel preparations like the use of polyethylene glycol may be avoided.

  1. Palatal growth in complete unilateral cleft lip and palate patients following neonatal cheiloplasty: Classic and geometric morphometric assessment.

    Science.gov (United States)

    Hoffmannova, Eva; Bejdová, Šárka; Borský, Jiri; Dupej, Ján; Cagáňová, Veronika; Velemínská, Jana

    2016-11-01

    A new method of early neonatal cheiloplasty has recently been employed on patients having complete unilateral cleft lip and palate (cUCLP). We aimed to investigate (1) their detailed palatal morphology before surgery and growth during the 10 months after neonatal cheiloplasty, (2) the growth of eight dimensions of the maxilla in these patients, (3) the development of these dimensions compared with published data on noncleft controls and on cUCLP patients operated using later operation protocol (LOP; 6 months of age). Sixty-six virtual dental models of 33 longitudinally evaluated cUCLP patients were analysed using metric analysis, a dense correspondence model, and multivariate statistics. We compared the palatal surfaces before neonatal cheiloplasty (mean age, 4 days) and before palatoplasty (mean age, 10 months). The palatal form variability of 10-month-old children was considerably reduced during the observed period thanks to their undisturbed growth, that is, the palate underwent the same growth changes following neonatal cheiloplasty. A detailed colour-coded map identified the most marked growth at the anterior and posterior ends of both segments. The maxilla of cUCLP patients after neonatal cheiloplasty had a growth tendency similar to noncleft controls (unlike LOP). Both methodological approaches showed that early neonatal cheiloplasty in cUCLP patients did not prevent forward growth of the upper jaw segments and did not reduce either the length or width of the maxilla during the first 10 months of life. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  2. Atypically thick and high location of the Wrisberg ligament in patients with a complete lateral discoid meniscus

    International Nuclear Information System (INIS)

    Kim, Eun Young; Choi, Sang-Hee; Kwon, Jong Won; Ahn, Jin Hwan

    2008-01-01

    The purpose of this study was to document the relationship between a discoid lateral meniscus and a thickened Wrisberg ligament with a higher location on the medial femoral condyle. Between July 2002 and February 2006, 100 consecutive patients who had a complete lateral discoid meniscus and another 100 patients without a discoid lateral meniscus (control group) were included. Two radiologists retrospectively reviewed all of the magnetic resonance images, paying particular attention to the presence and thickness of the Wrisberg ligament and the location of the attachment of the Wrisberg ligament to the medial femoral condyle (types I, II, or III). We assumed that type I Wrisberg ligaments had a higher location. All 141 patients had a Wrisberg ligament (71%). There were 73 patients (73%) in the discoid group and 68 patients (68%) in the non-discoid group. The mean thickness of the Wrisberg ligament in the patients in the discoid and non-discoid groups was 2.1 mm (range, 0.4-4.7 mm; median, 2.1 mm) and 1.6 mm (range, 0.4-4.5 mm; median, 1.3 mm), respectively. The Wrisberg ligaments of the discoid group were thicker than the non-discoid group (p=0.0002). The Wrisberg ligament was attached to the upper part of the medial femoral condyle in the discoid group more often than in the non-discoid group (p<0.0001). (orig.)

  3. Relationships among neurocognition, symptoms and functioning in patients with schizophrenia: a path-analytic approach for associations at baseline and following 24 weeks of antipsychotic drug therapy

    Directory of Open Access Journals (Sweden)

    Keefe Richard SE

    2009-07-01

    Full Text Available Abstract Background Neurocognitive impairment and psychiatric symptoms have been associated with deficits in psychosocial and occupational functioning in patients with schizophrenia. This post-hoc analysis evaluates the relationships among cognition, psychopathology, and psychosocial functioning in patients with schizophrenia at baseline and following sustained treatment with antipsychotic drugs. Methods Data were obtained from a clinical trial assessing the cognitive effects of selected antipsychotic drugs in patients with schizophrenia. Patients were randomly assigned to 24 weeks of treatment with olanzapine (n = 159, risperidone (n = 158, or haloperidol (n = 97. Psychosocial functioning was assessed with the Heinrichs-Carpenter Quality of Life Scale [QLS], cognition with a standard battery of neurocognitive tests; and psychiatric symptoms with the Positive and Negative Syndrome Scale [PANSS]. A path-analytic approach was used to evaluate the effects of changes in cognitive functioning on subdomains of quality of life, and to determine whether such effects were direct or mediated via changes in psychiatric symptoms. Results At baseline, processing speed affected functioning mainly indirectly via negative symptoms. Positive symptoms also affected functioning at baseline although independent of cognition. At 24 weeks, changes in processing speed affected changes in functioning both directly and indirectly via PANSS negative subscale scores. Positive symptoms no longer contributed to the path-analytic models. Although a consistent relationship was observed between processing speed and the 3 functional domains, variation existed as to whether the paths were direct and/or indirect. Working memory and verbal memory did not significantly contribute to any of the path-analytic models studied. Conclusion Processing speed demonstrated direct and indirect effects via negative symptoms on three domains of functioning as measured by the QLS at baseline and

  4. Clinical and biochemical effects of a 3-week program of diet combined with spa therapy in obese and diabetic patients: a pilot open study

    Science.gov (United States)

    Fioravanti, Antonella; Adamczyk, Przemysław; Pascarelli, Nicola Antonio; Giannitti, Chiara; Urso, Renato; Tołodziecki, Michał; Ponikowska, Irena

    2015-07-01

    Obesity is a major risk factor for arterial hypertension, coronary artery disease, dyslipidemias, and type 2 diabetes. Spa therapy has long been used for treating obesity and its comorbidities. Enlargement of adipose tissue has been linked to a dysregulation of adipokine secretion and adipose tissue inflammation. Adipokines are currently investigated as potential drug targets in these conditions. Our primary aim was to assess the clinical efficacy of a 3-week program of diet combined with spa therapy in obese patients with and without type 2 diabetes. The secondary aim was to examine whether this combined program influences the response of serum levels of leptin, adiponectin, visfatin, and high-sensitivity C-reactive protein. Fifty obese males were enrolled and 21 of these featured a type 2 diabetes. During the 3-week period of the study, the patients were on a 1,000-kcal diet and were involved in mineral bath and total body's mud-pack applications (15 procedures). Patients were assessed at baseline and at the end of the therapy for clinical and biochemical parameters (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, glycemia, and adipokines). We showed that a 3-week program of spa therapy in obese patients induced significant decrease of body weight, body mass index, triglycerides, total cholesterol, low-density lipoprotein (LDL) cholesterol, glycemia, and serum levels of leptin and high-sensitivity C-reactive protein. So, a cycle of mud-bath therapy associated with a controlled diet may be a promising treatment for obesity and type 2 diabetes decreasing body weight and many risk factors for atherosclerosis and metabolic syndrome.

  5. Patient organizations' funding from pharmaceutical companies: is disclosure clear, complete and accessible to the public? An Italian survey.

    Directory of Open Access Journals (Sweden)

    Cinzia Colombo

    Full Text Available BACKGROUND: Many patients' and consumers' organizations accept drug industry funding to support their activities. As drug companies and patient groups move closer, disclosure become essential for transparency, and the internet could be a useful means of making sponsorship information accessible to the public. This survey aims to assess the transparency of a large group of Italian patient and consumer groups and a group of pharmaceutical companies, focusing on their websites. METHODOLOGY/PRINCIPAL FINDINGS: Patient and consumer groups were selected from those stated to be sponsored by a group of pharmaceutical companies on their websites. The websites were examined using two forms with principal (name of drug companies providing funds, amount of funding and secondary indicators of transparency (section where sponsors are disclosed, update of sponsorship. Principal indicators were applied independently by two reviewers to the patient and consumer groups' websites. Discordances were solved by discussion. One hundred fifty-seven Italian patient and consumer groups and 17 drug companies were considered. Thirteen drug companies (76% named at least one group funded, on their Italian websites. Of these, four (31% indicated the activities sponsored and two (15% the amount of funding. Of the 157 patient and consumer groups, 46 (29% named at least one pharmaceutical company as providing funds. Three (6% reported the amount of funding, 25 (54% the activities funded, none the proportion of income derived from drug companies. Among the groups naming pharmaceutical company sponsors, 15 (33% declared them in a dedicated section, five (11% on the home page, the others in the financial report or other sections. CONCLUSIONS/SIGNIFICANCE: Disclosure of funds is scarce on Italian patient and consumer groups' websites. The levels of transparency need to be improved. Disclosure of patient and consumer groups provided with funds is frequent on Italian pharmaceutical

  6. A 13-Weeks Mindfulness Based Pain Management Program Improves Psychological Distress in Patients with Chronic Pain Compared with Waiting List Controls

    DEFF Research Database (Denmark)

    Andersen, Tonny Elmose; Vægter, Henrik Bjarke

    2016-01-01

    BACKGROUND: Eradication of pain is seldom an option in chronic pain management. Hence, mindfulness meditation has become popular in pain management. OBJECTIVE: This pilot study compared the effect of a 13-weeks cognitive behavioural therapy program with integrated mindfulness meditation (CBTm......) in patients with chronic non-malignant pain with a control condition. It was hypothesised that the CBTm program would reduce pain intensity and psychological distress compared to the control condition and that level of mindfulness and acceptance both would be associated with the reduction in pain intensity...... and psychological distress were performed in both groups at baseline and after 13 weeks. RESULTS: The CBTm program reduced depression, anxiety and pain-catastrophizing compared with the control group. Increased level of mindfulness and acceptance were associated with change in psychological distress...

  7. Civamide cream 0.075% in patients with osteoarthritis of the knee: a 12-week randomized controlled clinical trial with a longterm extension.

    Science.gov (United States)

    Schnitzer, Thomas J; Pelletier, Jean-Pierre; Haselwood, Doug M; Ellison, William T; Ervin, John E; Gordon, Richard D; Lisse, Jeffrey R; Archambault, W Tad; Sampson, Allan R; Fezatte, Heidi B; Phillips, Scott B; Bernstein, Joel E

    2012-03-01

    To evaluate the safety and efficacy of civamide cream 0.075% for the treatment of osteoarthritis (OA) of the knee. We conducted a 12-week, multicenter, randomized, double-blind study with a 52-week open-label extension. Patients with OA of the knee received either civamide cream 0.075% or a lower dose of civamide cream, 0.01%, as the control. The 3 co-primary endpoints in the double-blind study were the time-weighted average (TWA) of change from baseline to Day 84 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and the Subject Global Evaluation (SGE). In the 52-week open-label extension study, the Osteoarthritis Pain Score and SGE were assessed. A total of 695 patients were randomized to receive civamide cream 0.075% (n = 351) or civamide cream 0.01% (control; n = 344) in the double-blind study. Significance in favor of civamide cream 0.075% was achieved for the TWA for all 3 co-primary efficacy variables: WOMAC pain (p = 0.009), WOMAC physical function (p < 0.001), and SGE (p = 0.008); and at Day 84 for these 3 variables (p = 0.013, p < 0.001, and p = 0.049, respectively). These analyses accounted for significant baseline-by-treatment interactions. In the 52-week open-label extension, efficacy was maintained. Civamide cream 0.075% was well tolerated throughout the studies. These studies demonstrate the efficacy of civamide cream for up to 1 year of continuous use. Civamide cream, with its lack of systemic absorption, does not have the potential for serious systemic toxicity, in contrast to several other OA treatments.

  8. Effects of a 6-Week Aquatic Treadmill Exercise Program on Cardiorespiratory Fitness and Walking Endurance in Subacute Stroke Patients: A PILOT TRIAL.

    Science.gov (United States)

    Han, Eun Young; Im, Sang Hee

    2017-03-15

    To assess the feasibility and safety of a 6-week course of water walking performed using a motorized aquatic treadmill in individuals with subacute stroke for cardiorespiratory fitness, walking endurance, and activities of daily living. Twenty subacute stroke patents were randomly assigned to aquatic treadmill exercise (ATE) or land-based exercise (LBE). The ATE group (n = 10) performed water-based aerobic exercise on a motorized aquatic treadmill, and the LBE group (n = 10) performed land-based aerobic exercise on a cycle ergometer. Both groups performed aerobic exercise for 30 minutes, 5 times per week for 6 weeks. Primary outcome measures were 6-minute walk test for walking endurance and cardiopulmonary fitness parameters of a symptom-limited exercise tolerance test, and secondary measures were Korean version of the Modified Barthel Index (K-MBI) for activities of daily living. All variables were assessed at baseline and at the end of the intervention. The ATE group showed significant improvements in 6-minute walk test (P = .005), peak oxygen uptake (V·o2peak; P = .005), peak heart rate (P = .007), exercise tolerance test duration (P = .005), and K-MBI (P = .008). The LBE group showed a significant improvement only in K-MBI (P = .012). In addition, improvement in V·o2peak was greater in the ATE than in the LBE group. This preliminary study showed that a 6-week ATE program improved peak aerobic capacity and walking endurance in patients with subacute stroke. The improvement in V·o2peak after an ATE exercise program was greater than that observed after an LBE program. Therefore, ATE effectively improves cardiopulmonary fitness in patients with subacute stroke.

  9. Molecular characteristics of Clostridium difficile strains from patients with a first recurrence more than 8 weeks after the primary infection.

    Science.gov (United States)

    Chen, Yijian; Rashid, Mamun Ur; Huang, Haihui; Fang, Hong; Nord, Carl Erik; Wang, Minggui; Weintraub, Andrej

    2017-08-01

    Nearly all published studies of recurrent Clostridium difficile infections (CDI) report recurrent CDI within 8 weeks after the primary infection. This study explored the molecular characteristics of C. difficile isolates from the first recurrent CDI more than 8 weeks after the primary infection. Consecutive hospitalized patients with a recurrent CDI more than 8 weeks after a primary infection were enrolled prospectively from January 2008 to February 2011. All C. difficile isolates of the primary and recurrent infections were collected and subjected to polymerase chain reaction ribotyping and antimicrobial susceptibility testing. There were 62 cases of CDI in this study, which included 32 cases (51.6%) of recurrence due to the same ribotype of C. difficile, 26 (41.9%) cases due to a different ribotype, and four (6.5%) cases with 2-4 recurrences due to the same or different strains. One hundred and forty C. difficile isolates were obtained, which included 62 primary CDI isolates and 78 recurrent isolates. Ribotype 020 was the most common C. difficile strain in primary and recurrent infections. Ribotype 001 accounted for 15.4% (10/78) of recurrent infections and 3.2% (2/62) of primary infections (p = 0.0447). The minimum inhibitory concentration at 90% (MIC 90 ) values of linezolid, moxifloxacin, and clindamycin against type 001 strains were much higher, compared to the three other common ribotypes. Recurrent CDI more than 8 weeks after a primary infection can be caused by the same or different C. difficile ribotype at similar percentages. Ribotype 001 C. difficile strains, which have a lower susceptibility to antimicrobials, were isolated more frequently in patients with a recurrent CDI. Copyright © 2015. Published by Elsevier B.V.

  10. Completion of Limitation of Medical Treatment forms by junior doctors for patients with dementia: clinical, medicolegal and education perspectives.

    Science.gov (United States)

    Yoong, Jaclyn; MacPhail, Aleece; Trytel, Gael; Rajendram, Prashanti Yalini; Winbolt, Margaret; Ibrahim, Joseph E

    2017-10-01

    Objective Limitation of Medical Treatment (LMT) forms are an essential element of end-of-life care. Decision making around LMT is complex and often involves patients with dementia. Despite the complexity, junior doctors frequently play a central role in completing LMT forms. The present study sought perspectives from a range of stakeholders (hospital clinicians, medical education personnel, legal and advocacy staff) about junior doctors' roles in completing LMT forms in general and for patients with dementia. Methods Qualitative data were gathered in semi-structured interviews (SSI) and theoretical concepts were explored in roundtable discussion (RD). Participants were recruited through purposive and convenience sampling drawing on healthcare and legal personnel employed in the public hospital and aged care systems, selected from major metropolitan hospitals, healthcare and legal professional bodies and advocacy organisations in Victoria, Australia. The contents of the SSIs and RD were subject to thematic analysis using a framework approach. Data were indexed according to the topics established in the study aim; categories were systematically scrutinised, from which key themes were distilled. Results Stakeholders reported that completing LMT forms was difficult for junior doctors because of a lack of medical and legal knowledge, as well as clinical inexperience and inadequate training. Healthcare organisations (HCOs) either lacked policies about the role of junior doctors or had practices that were discordant with policy. In this process, there were substantial gaps pertaining to patients with dementia. Recommendations made by the study participants included the provision of supervised clinical exposure and additional training for junior doctors, strengthening HCO policies and explicit consideration of the needs of patients with dementia. Conclusions LMT forms should be designed for clarity and consistency across HCOs. Enhancing patient care requires appropriate

  11. Pegylated Long-Acting Human Growth Hormone Possesses a Promising Once-Weekly Treatment Profile, and Multiple Dosing Is Well Tolerated in Adult Patients with Growth Hormone Deficiency

    DEFF Research Database (Denmark)

    Søndergaard, Esben; Klose, Marianne Christina; Hansen, Mette

    2011-01-01

    Background: Recombinant human GH (rhGH) replacement therapy in children and adults currently requires daily sc injections for several years or lifelong, which may be both inconvenient and distressing for patients. NNC126-0083 is a pegylated rhGH developed for once-weekly administration. Objectives......: Our objective was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of NNC126-0083 in adult patients with GH deficiency (GHD). Subjects and Methods: Thirty-three adult patients with GHD, age 20-65 yr, body mass index 18.5-35.0 kg/m(2), and glycated...... to 240 h after the third dosing. Physical examination, antibodies, and local tolerability were assessed. Results: NNC126-0083 was well tolerated with no difference in local tolerability compared with placebo and with no signs of lipoatrophy. A more than dose-proportional exposure was observed...

  12. Complete Remission Obtained with Azacitidine in a Patient with Concomitant Therapy Related Myeloid Neoplasm and Pulmonary Mucormycosis

    Directory of Open Access Journals (Sweden)

    Saveria Capria

    2013-07-01

    Full Text Available Mucormycosis is the third cause of invasive mycosis after candidiasis and aspergillosis in AML patients, representing a poor prognostic factor associated with a high rate of fatal outcome. We report  a case of a patient with AML and a concomitant pulmonary mucormycosis at diagnosis,  who obtained a  complete remission both of her AML and of the fungal infection. The incidence of the infection at the onset of leukemia is extremely unusual, and, to our knowledge, the sporadic cases reported in the literature are included in heterogeneous series retrospectively examined. In our case, Liposomal Amphotericin B as single agent appeared incapable of controlling the infection, so anti-infective therapy was intensified with posaconazole and simultaneously antileukemic treatment with 5-azacitidine was started, with the understanding that the only antifungal treatment would not have been able to keep the infection under control for a long time if not associated with a reversal of neutropenia related to the disease. We observed a progressive improvement of the general conditions, a healing of pneumonia and a complete remission of the leukemic disease, suggesting that a careful utilization of the new compounds available today, in terms of both antifungal and antileukemic treatment, may offer a curative chance a patient who would have otherwise been considered unfit for a potentially curative therapeutic strategy.

  13. [A case of a geriatric patient with stage IV anal canal cancer showing complete response to chemoradiation therapy].

    Science.gov (United States)

    Kuroda, Masatoshi; Hirai, Ryuji; Ikeda, Eiji; Tsuji, Hisashi; Takagi, Shoji; Yamano, Toshihisa; Yoshitomi, Seiji

    2012-11-01

    We present a case in which chemoradiation therapy was effective in a geriatric patient with Stage IV anal canal cancer. The patient is an 81-year-old woman who complained of proctorrhagia and anal pain. She was referred to us by her family doctor who suspected rectal cancer. Tumors as large as 6.5 cm in diameter mainly on the right side of the rectum as well as 2 palpable enlarged lymph nodes on the right inguinal area, were found during the initial physical examination. Squamous cell carcinoma was elevated to 16 ng/mL. A CT scan revealed that irregularly shaped masses as large as 7 cm in diameter were externally exposed on the right side of the rectum along with enlarged lymph nodes on the right inguinal area and metastasis at S7 lesion in the liver. Squamous cell carcinoma was diagnosed from biopsy results. Due to her age, the chemotherapy regimen was S-1+CDDP with radiation therapy and 4-port irradiation (50.4 Gy) of the primary tumor, interior of the pelvis, and inguinal lymph nodes. Partial response was observed upon completion of treatment, and complete response was obtained after 6 months. She is currently an outpatient taking S-1: 60 mg/day orally. There is no indication of cancer recurrence after 1 year and 3 months, and she continues to visit an outpatient clinic for regular follow-ups. These results demonstrate the effectiveness of chemoradiation therapy for geriatric patients with Stage IV anal canal cancer.

  14. Identifying barriers to glycemic control in patients with type 2 diabetes after completion of an accredited education program.

    Science.gov (United States)

    Gildea, Chris M; Lantaff, Wendy M; Olenik, Nicole L

    The objective of this study was to identify patient-perceived barriers to achieving A1C targets after receiving instruction in an accredited diabetes education program. Qualitative research using semistructured interviews and thematic analyses. One pharmacist-run diabetes center located within an independent community pharmacy in a suburban region of southern Indiana. A total of 17 participants between the ages of 41-78 were interviewed in March and April 2016. Not applicable. Patient-perceived barriers to attaining glycemic control after completion of a pharmacist-taught diabetes self-management education (DSME) program accredited by the American Association of Diabetes Educators. Participants reported a variety of perceived barriers to glycemic control subsequent to the receipt of structured education. Seven major themes emerged: 1) health care provider factors; 2) self-identified indiscretions; 3) psychological barriers and poor social support; 4) knowledge deficits; 5) personal injury or adverse drug events; 6) time constraints and competing life demands; and 7) financial constraints. Participants reported a variety of perceived barriers to achieving A1C targets after completing DSME. Incorporation of solutions and coping mechanisms to these barriers into diabetes education programs may help patients attain glycemic control. Other factors may require individualized attention outside of DSME in follow-up episodes of diabetes care. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  15. Weekly docetaxel versus CMF as adjuvant chemotherapy for elderly breast cancer patients: safety data from the multicentre phase 3 randomised ELDA trial.

    Science.gov (United States)

    Nuzzo, Francesco; Morabito, Alessandro; De Maio, Ermelinda; Di Rella, Francesca; Gravina, Adriano; Labonia, Vincenzo; Landi, Gabriella; Pacilio, Carmen; Piccirillo, Maria Carmela; Rossi, Emanuela; D'Aiuto, Giuseppe; Thomas, Renato; Gori, Stefania; Colozza, Mariantonietta; De Placido, Sabino; Lauria, Rossella; Signoriello, Giuseppe; Gallo, Ciro; Perrone, Francesco; de Matteis, Andrea

    2008-05-01

    Within an ongoing multicentre phase 3 randomised trial (ELDA, cancertrials.gov ID: NCT00331097), early breast cancer patients, 65-79 years old, with average to high risk of recurrence, are randomly assigned to receive CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, fluorouracil 600 mg/m2, days 1-8) or docetaxel (35 mg/m2 days 1-8-15), every 4 weeks. Here we report an unplanned safety analysis prompted by an amendment introducing creatinine clearance as a tool to adjust methotrexate dose. Before such change, 101 patients with a median age of 70 were randomly assigned CMF (53 patients) or docetaxel (48 patients). At least one grades 3-4 toxic event of any type was reported in 40 (75.5%) and 19 (39.6%) patients with CMF and docetaxel, respectively (p=0.0002). Grades 3-4 hematological events were observed in 37 (69.8%) vs. 4 (8.3%) cases (p<0.0001) and grades 3-4 non-hematological toxicity in 12 (22.6%) vs. 15 (31.2%) patients (p=0.11), with CMF and docetaxel, respectively. A higher incidence of anemia, neutropenia, thrombocytopenia and febrile neutropenia was reported with CMF. Constipation, mucositis, nausea and vomiting were more common with CMF; diarrhoea, abdominal pain, dysgeusia, neuropathy and liver toxicity were more frequent with docetaxel. No significant interaction was found between the occurrence of severe toxicity and baseline variables, including creatinine clearance and geriatric activity scales. In conclusion, weekly docetaxel appears to be less toxic than CMF in terms of hematological toxicity.

  16. The Effect of Four-Week Period of Aerobic Exercise with Cinnamon Consumption on Lipoprotein Indicates and Blood sugar in Diabetic Female Patients (Type 2

    Directory of Open Access Journals (Sweden)

    M Dastani

    2013-01-01

    Full Text Available Introduction: Cinnamon as an herbal medicine has the ability to reduce blood glucose and lipoproteins in diabetic patients. Based on the positive effects of exercise on diabetic patients, the present study was conducted to investigate the effect of Four weeks Period aerobic exercise alongside using cinnamon on lipoprotein parameters and blood glucose in women with type 2 diabetes. Methods: Thirty diabetic women were voluntarily selected and were randomly divided into three groups: 1 aerobic exercise group; 2 aerobic exercise alongside using cinnamon; and 3 control group. Aerobic exercise took four weeks with 60 percent of maximum heart rate. Blood samples were collected at the beginning and end of the study. Results: Blood glucose, the fat percentage and HDL, and the ratio of LDL to HDL in the first group significantly decreased and in the second group increased (P<0.05. Also the first group showed a significant reduction in triglyceride. The only significant change observed in the control group was a significant increase in the level of LDL. Comparing the first and second group, it was observed that in the second group the level of total cholesterol decreased and the ratio of LDL to HDL increased (P<0.05. Conclusion: Using cinnamon alongside aerobic exercise is likely to be beneficial in regulating the concentration of blood glucose and lipids in diabetic patients.

  17. Complete Genome Sequences of Zika Virus Strains Isolated from the Blood of Patients in Thailand (2014) and Philippines (2012)

    Science.gov (United States)

    2016-03-09

    Complete genome sequences of Zika Virus strains isolated from the blood of patients in 1 Thailand (2014) and Philippines (2012). 2 Ellison,D.W.1...Institute, Seoul, Republic of Korea. 20 21 Running Head: Zika Virus Genomes 22 23 ABSTRACT 24 ZIKV is an arbovirus and member of the family...genome sequences of two Zika Virus (ZIKV) strains, Zika virus /H.sapiens-27 tc/THA/2014/SV0127-14 and Zika virus /H.sapiens-tc/PHL/2012/CPC-0740, isolated

  18. Real versus virtual phenotype to guide treatment in heavily pretreated patients: 48-week follow-up of the Genotipo-Fenotipo di Resistenza (GenPheRex) trial.

    Science.gov (United States)

    Mazzotta, Francesco; Lo Caputo, Sergio; Torti, Carlo; Tinelli, Carmine; Pierotti, Piera; Castelli, Francesco; Lazzarin, Adriano; Angarano, Gioacchino; Maserati, Renato; Gianotti, Nicola; Ladisa, Nicoletta; Quiros-Roldan, Eugenia; Rinehart, Alex R; Carosi, Giampiero

    2003-03-01

    We compared viroimmunologic response after real phenotype (r-PHT) versus virtual phenotype (v-PHT) in patients failing highly active antiretroviral therapy (HAART). A total of 201 patients with >2 years of exposure, more than six experienced drugs, >1000 HIV RNA copies/mL, and on stable HAART for >6 months were randomized to the r-PHT or v-PHT arm. The primary end point was the proportion of HIV plasma viral load (pVL) 0.5 log(10) copies/mL, and absolute CD4 cell change. In the intention-to-treat-last observation carried forward analysis, study outcomes were not significantly different between arms over 48 weeks of follow-up: 20% and 24% pVL 0.5 log(10) copies/mL; -0.92 and -0.94(10) log copies/mL mean pVL decrease; and +41.6 and +94.4 cells/mm(3) mean absolute CD4 increase in the r-PHT and v-PHT arms, respectively. On-treatment analyses gave similar results. In the multivariate analysis of pVL <400 copies/mL, the following covariates were independent predictors at week 48: adherence (OR p= 0.25; p=.002), baseline CD4 (OR = 4.39; p=.007), intravenous drug use as risk factor for HIV acquisition (OR = 0.33; p=.024), and sensitivity score of the new regimens by biologic cut-offs (OR = 1.84; p=.029). Prescribed drugs for which patients were naive resulted in marginal prediction (OR = 1.93; p=.054). In conclusion, virologic and immunologic outcomes did not differ when r-PHT or v-PHT was used in this cohort of heavily pretreated patients. Several factors should be considered to take better advantage of resistance testing, including treatment history, clinical status, and patients' ability to adhere to treatment.

  19. Obesity is an independent prognostic factor of decreased pathological complete response to neoadjuvant chemotherapy in breast cancer patients.

    Science.gov (United States)

    Karatas, Fatih; Erdem, Gokmen Umut; Sahin, Suleyman; Aytekin, Aydin; Yuce, Deniz; Sever, Ali R; Babacan, Taner; Ates, Ozturk; Ozisik, Yavuz; Altundag, Kadri

    2017-04-01

    The relation between higher body mass index (BMI) and pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in breast cancer (BC) is a controversial issue according to the data of Western and Asian patients. The aim of this study is to evaluate BMI and pCR to NAC and discuss the importance of pCR outcomes in Turkish BC patients as a bridging country between Europe and Asia. Of the 4423 BC patients diagnosed between the years 1994 and 2015 in Hacettepe University Cancer Institute, 295 female patients with stage II and III BC were enrolled in the study. Three different group divisions were done according to patients' BMI as normal or underweight (N/U) patients (BMI factors. In this study, a total number of 93 (31.5%) patients were N/U, 107 (36.3%) patients were OW and 95 (32.2%) patients were OB. Among groups, except for the age, no baseline clinicopathological differences were found. In 70 (23.7%) patients, pCR was achieved. pCR rates in N/U, OW and OB were 31.2%, 22.4%, and 17.9% respectively, showing a considerable trend towards significance (P = 0.09 in chi-square test). In the multivariate logistic regression analysis, obesity was an independent adverse prognostic feature on pCR to NAC compared to N/U patients (OR, 0.34; 95% CI, 0.13 to 0.85, P = 0.02). The recurrence rates were slightly increased with the increase of BMI (N/U = 24.7%, OW = 29.0% and OB = 40%; P = 0.06 respectively). Median RFS was significantly higher in N/U group compared to OB patients (150 vs. 76 months respectively, P = 0.03) and was also higher in pCR group compared to non-pCR patients (151 vs. 77 months P = 0.004). Median OS was significantly higher in N/U patients compared to OB patients (N/U = not reached, OW = 211 and OB = 114 months; P = 0.01) and was also higher in pCR group compared to non-pCR patients (not reached vs. 211 months P = 0.04). In Cox regression analysis; pCR, histopathological grade and TNBC were found as independent

  20. Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Watson Susan B

    2011-02-01

    Full Text Available Abstract Background In a recently published 24-week maintenance study of olanzapine long-acting injection (LAI in schizophrenia (Kane et al., 2010, apparent dose-associated changes were noted in both efficacy and safety parameters. To help clinicians balance safety and efficacy when choosing a dose of olanzapine LAI, we further studied these changes. Methods Outpatients with schizophrenia who had maintained stability on open-label oral olanzapine for 4 to 8 weeks were randomly assigned to "low" (150 mg/2 weeks; N = 140, "medium" (405 mg/4 weeks; N = 318, or "high" (300 mg/2 weeks; N = 141 dosages of olanzapine LAI for 24 weeks. Potential relationships between dose and several safety or efficacy measures were examined via regression analysis, the Jonckheere-Terpstra test (continuous data, or the Cochran-Armitage test (categorical data. Results Safety parameters statistically significantly related to dose were mean weight change (low: +0.67 [SD = 4.38], medium: +0.89 [SD = 3.87], high: +1.70 [SD = 4.14] kg, p = .024; effect size [ES] = 0.264 high vs. low dose, mean change in prolactin (low: -5.61 [SD = 12.49], medium: -2.76 [SD = 19.02], high: +3.58 [SD = 33.78] μg/L, p = .001; ES = 0.410 high vs. low dose, fasting triglycerides change from normal at baseline to high (low: 3.2%, medium: 6.0%, high: 18.9%, p = .001; NNT = 7 high vs. low dose and fasting high-density lipoprotein cholesterol change from normal at baseline to low (low: 13.8%, medium: 19.6%, high: 30.7%, p = .019; NNT = 6 high vs. low dose. Efficacy measures significantly related to dose included Positive and Negative Syndrome Scale total score mean change (low: +2.66 [SD = 14.95], medium: -0.09 [SD = 13.47], high: -2.19 [SD = 13.11], p Conclusions Analyses of several safety and efficacy parameters revealed significant associations with dose of olanzapine LAI, with the highest dose generally showing greater efficacy as well as greater adverse changes in metabolic safety measures. When

  1. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

    Science.gov (United States)

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. CRiS KCT0001771.

  2. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Yu-Mi Lee

    Full Text Available Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D; however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals.Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46 or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47 for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks.The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017. When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%. The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks.Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms.CRiS KCT0001771.

  3. Treatment Compliance with Fixed-Dose Combination of Vildagliptin/Metformin in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin Monotherapy: A 24-Week Observational Study

    Directory of Open Access Journals (Sweden)

    Grigorios Rombopoulos

    2015-01-01

    Full Text Available Objective. To evaluate the differences in treatment compliance with vildagliptin/metformin fixed-dose versus free-dose combination therapy in patients with type 2 diabetes mellitus (T2DM in Greece. Design. Adult patients with T2DM, inadequately controlled with metformin monotherapy, (850 mg bid, participated in this 24-week, multicenter, observational study. Patients were enrolled in two cohorts: vildagliptin/metformin fixed-dose combination (group A and vildagliptin metformin free-dose combination (group B. Results. 659 patients were enrolled, 360 were male, with mean BMI 30.1, mean T2DM duration 59.6 months, and mean HbA1c at baseline 8%; 366 patients were assigned to group A and 293 to group B; data for 3 patients was missing. In group A, 98.9% of patients were compliant with their treatment compared to 84.6% of group B. The odds ratio for compliance in group A versus B was (OR 18.9 (95% CI: 6.2, 57.7; P<0.001. In group A mean HbA1c decreased from 8.1% at baseline to 6.9% (P<0.001 at the study end and from 7.9% to 6.8% (P<0.001 in group B. Conclusions. Patients in group A were more compliant than patients in group B. These results are in accordance with international literature suggesting that fixed-dose combination therapies lead to increased compliance to treatment.

  4. Frontal fasciculi and psychotic symptoms in antipsychotic-naive patients with schizophrenia before and after 6 weeks of selective dopamine D2/3 receptor blockade

    DEFF Research Database (Denmark)

    Ebdrup, Bjørn H; Raghava, Jayachandra M; Nielsen, Mette Ødegaard

    2016-01-01

    /3 receptor blockade would restore white matter. METHODS: Between December 2008 and July 2011, antipsychotic-naive patients with first-episode schizophrenia and matched healthy controls underwent baseline examination with 3 T MRI diffusion tensor imaging and clinical assessments. We assessed group differences...... with first-episode schizophrenia and 38 controls in our analysis, and 28 individuals in each group completed the study. At baseline, whole brain TBSS analyses revealed lower FA in patients in the right anterior thalamic radiation (ATR), right cingulum, right inferior longitudinal fasciculus and right...

  5. Clinical diagnosis of partial or complete anterior cruciate ligament tears using patients' history elements and physical examination tests

    Science.gov (United States)

    Fallaha, Michel; Belzile, Sylvain; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Feldman, Debbie; Sylvestre, Marie-Pierre; Vendittoli, Pascal-André; Desmeules, François

    2018-01-01

    Objective To assess the diagnostic validity of clusters combining history elements and physical examination tests to diagnose partial or complete anterior cruciate ligament (ACL) tears. Design Prospective diagnostic study. Settings Orthopaedic clinics (n = 2), family medicine clinics (n = 2) and community-dwelling. Participants Consecutive patients with a knee complaint (n = 279) and consulting one of the participating orthopaedic surgeons (n = 3) or sport medicine physicians (n = 2). Interventions Not applicable. Main outcome measures History elements and physical examination tests performed independently were compared to the reference standard: an expert physicians’ composite diagnosis including history elements, physical tests and confirmatory magnetic resonance imaging. Penalized logistic regression (LASSO) was used to identify history elements and physical examination tests associated with the diagnosis of ACL tear and recursive partitioning was used to develop diagnostic clusters. Diagnostic accuracy measures including sensitivity (Se), specificity (Sp), predictive values and positive and negative likelihood ratios (LR+/-) with associated 95% confidence intervals (CI) were calculated. Results Forty-three individuals received a diagnosis of partial or complete ACL tear (15.4% of total cohort). The Lachman test alone was able to diagnose partial or complete ACL tears (LR+: 38.4; 95%CI: 16.0–92.5). Combining a history of trauma during a pivot with a “popping” sensation also reached a high diagnostic validity for partial or complete tears (LR+: 9.8; 95%CI: 5.6–17.3). Combining a history of trauma during a pivot, immediate effusion after trauma and a positive Lachman test was able to identify individuals with a complete ACL tear (LR+: 17.5; 95%CI: 9.8–31.5). Finally, combining a negative history of pivot or a negative popping sensation during trauma with a negative Lachman or pivot shift test was able to exclude both partial or complete ACL tears (LR

  6. Effects of 12 weeks of treatment with fermented milk on blood pressure, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Hove, K D; Brøns, C; Færch, K

    2015-01-01

    helveticus on BP, glycaemic control and cardiovascular risk factors in T2D. DESIGN: A randomised, double-blinded, prospective, placebo-controlled study. METHODS: In one arm of a factorial study design, 41 patients with T2D were randomised to receive 300 ml milk fermented with L. helveticus (Cardi04 yogurt......OBJECTIVE: Studies have indicated a blood pressure (BP)-lowering effect of milk-derived peptides in non-diabetic individuals, but the cardiometabolic effects of such peptides in patients with type 2 diabetes (T2D) are not known. We investigated the effect of milk fermented with Lactobacillus......) (n=23) or 300 ml artificially acidified milk (placebo yogurt) (n=18) for 12 weeks. BPs were measured over 24-h, and blood samples were collected in the fasting state and during a meal test before and after the intervention. RESULTS: Cardi04 yogurt did not reduce 24-h, daytime or nighttime systolic...

  7. Identification of risk groups in patients with completely resected N1 non-small cell lung carcinoma

    International Nuclear Information System (INIS)

    Sawyer, T.E.; Bonner, J.A.; Gould, P.J.; Foote, R.L.; Deschamps, C.; Trastek, V.F.; Pairolero, P.C.; Allen, M.S.; Lange, C. M.; Li, H.

    1997-01-01

    Purpose: Although the potential benefits of radiation therapy and chemotherapy in the management of completely resected AJCC N1 non-small cell lung cancer are unknown, the majority of studies have failed to demonstrate a survival benefit with any neoadjuvant or adjuvant therapy. While it is possible that radiation therapy and chemotherapy are ineffective adjunctive therapies in this disease, it is also possible that previous studies have been diluted by the inclusion of patients at low risk for local recurrence and/or distant metastasis and therefore, this study was undertaken to assess these risks. Methods: From 1987 through 1990, 107 patients underwent complete resection of AJCC N1 non-small cell lung carcinoma and received no other treatment. These patients were the subject of a retrospective review to separate patients into high-, medium-, and low-risk groups with respect to freedom from local recurrence (FFLR), freedom from distant metastasis (FFDM), and overall survival (OS) utilizing a regression analysis of Cox and a regression tree analysis (Breiman LI et al, Wadsworth International Group, Belmont, CA 1984). Results: The 5-year rates of FFLR, FFDM, and OS were 62%, 53%, and 32% respectively. The following factors were assessed for potential relationships with FFLR, FFDM, and OS: status of the pre-operative bronchoscopy, type of surgery performed (segmentectomy/wedge resection vs. lobectomy vs. bilobectomy/pneumonectomy), number of involved N1 nodes, number of involved N1 stations, number of N1 nodes removed, number of N2 nodes removed, number of lung lobes involved, tumor grade, tumor histology (squamous vs non-squamous), AJCC T-stage, pathologic tumor size, and pathologic margin status. Regression analyses revealed that the factors independently associated with an improved outcome included a positive bronchoscopy (FFLR, p=.005), a greater number of N1 nodes dissected (FFDM, p=.02), and a lesser T-stage (OS, p=.01). Regression tree analyses were then

  8. Efficacy and Safety of an Herbal Therapy in Patients with Amnestic Mild Cognitive Impairment: A 24-Week Randomized Phase III Trial

    Directory of Open Access Journals (Sweden)

    Jinzhou Tian

    2017-01-01

    Full Text Available Objective. In the 24-week randomized, double-blind, double-placebo, parallel-controlled trial, we aimed to test the effects of herbal therapy with amnestic mild cognitive impairment (aMCI. Methods. A total of 324 patients with aMCI entered a 2-week placebo run-in period followed by 24 weeks’ treatment of either (a herbal capsule (5 shenwu capsules/administration, 3 times/day and placebo identical to donepezil tablets (n=216 or (b donepezil (5 mg/day and placebo identical to herbal capsule (n=108. Results. Herbal therapy showed a significant improvement on the primary efficacy measure, measured by Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog, and showed a mean decrease from baseline of 4.23 points at the endpoint, without a significant difference from the donepezil group. Secondary efficacy measurement of the Logical Memory II Delayed Story Recall subtest (DSR showed modest improvement in those taking herbal capsule compared to baseline, and there was no significant difference from donepezil group. The frequency of adverse events was much less in the herbal therapy group than the donepezil. Conclusion. Herbal therapy demonstrated a significant improvement in cognition and memory, which were similar to the donepezil in patients with aMCI. Herbal therapy was safe and well tolerated. Trial Registration. This study is registered with clinicaltrials.gov NCT01451749.

  9. A Cognitive-Behavioural Program (One Day a Week for Patients With Obesity and Binge Eating Disorder: Short-Term Follow-up Data

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    An Adriaens

    2008-12-01

    Full Text Available This paper describes an innovative cognitive behavioural program for the treatment of patients with binge eating disorder in the University Psychiatric Center K.U. Leuven Campus Kortenberg in Belgium. The program runs one day a week during 6 months and consists of 24 sessions. The most important therapeutic goals are: (1 normalization of eating habits and stopping the binge eating episodes; (2 promoting physical activity and a positive body experience; (3 learning specific skills such as assertivity, installing a functional self-evaluation system; learning to identify, tolerate and express negative emotions, promoting self-esteem and prevention of relapse. Overall, the goal is to promote both physical and psychological well-being and quality of life. Some preliminary research data on the effectiveness of this program are described. Despite a rather limited weight loss, the number of binges per week decreased significantly, which was the main therapeutic goal of the treatment. Furthermore, the results show some promising improvements on different psychological parameters in BED patients.

  10. 12 Weeks of Combined Endurance and Resistance Training Reduces Innate Markers of Inflammation in a Randomized Controlled Clinical Trial in Patients with Multiple Sclerosis

    Directory of Open Access Journals (Sweden)

    Nathalie Deckx

    2016-01-01

    Full Text Available Previously, we reported that patients with multiple sclerosis (MS demonstrate improved muscle strength, exercise tolerance, and lean tissue mass following a combined endurance and resistance exercise program. However, the effect of exercise on the underlying disease pathogenesis remains elusive. Since recent evidence supports a crucial role of dendritic cells (DC in the pathogenesis of MS, we investigated the effect of a 12-week combined exercise program in MS patients on the number and function of DC. We demonstrate an increased number of plasmacytoid DC (pDC following the exercise program. These pDC display an activated phenotype, as evidenced by increased numbers of circulating CD62L+ and CD80+ pDC. Interestingly, the number of CD80+ pDC positively correlates with the presence of IL-10-producing regulatory type 1 cells (Tr1, an important cell type for maintaining peripheral tolerance to self-antigens. In addition, decreased production of the inflammatory mediators, TNF-α and MMP-9, upon Toll-like receptor (TLR stimulation was found at the end of the exercise program. Overall, our findings suggest that the 12-week exercise program reduces the secretion of inflammatory mediators upon TLR stimulation and promotes the immunoregulatory function of circulating pDC, suggestive for a favorable impact of exercise on the underlying immunopathogenesis of MS.

  11. Improved survival and complete response rates in patients with advanced melanoma treated with concurrent ipilimumab and radiotherapy versus ipilimumab alone.

    Science.gov (United States)

    Koller, Kristian M; Mackley, Heath B; Liu, Jason; Wagner, Henry; Talamo, Giampaolo; Schell, Todd D; Pameijer, Colette; Neves, Rogerio I; Anderson, Bryan; Kokolus, Kathleen M; Mallon, Carol A; Drabick, Joseph J

    2017-01-02

    There is a growing body of evidence supporting the synergistic roles of radiotherapy and immunotherapy in the treatment of malignancy. Published case studies of the abscopal effect have been reported with the use of ipilimumab and radiotherapy in metastatic melanoma, but evidence supporting the routine use of this combination of therapy is limited. We conducted a retrospective analysis to evaluate patients treated with ipilimumab for advanced melanoma at a single institution from May 2011 to June 2015. Patients were grouped into those who had received concurrent radiotherapy while on ipilimumab (Ipi-RT), and those who did not. We then evaluated the treatment response following completion of ipilimumab. A total of 101 patients received ipilimumab in the prespecified time frame. 70 received Ipi-RT and 31 received ipilimumab without concurrent radiotherapy. Median overall survival (OS) was significantly increased in the concurrent Ipi-RT arm at 19 months vs. 10 months for ipilimumab alone (p = 0.01). Median progression free survival (PFS) was marginally increased in the Ipi-RT group compare with the ipilimumab alone group (5 months vs. 3 months, p = 0.20). Rates of complete response (CR) were significantly increased in the Ipi-RT group vs. ipilimumab alone (25.7% vs. 6.5%; p = 0.04), and rates of overall response (OR) in the groups were 37.1% vs. 19.4% (p = 0.11). No increase in toxicities was observed in the Ipi-RT group compare with ipilimumab alone. Prospective trials are needed to further clarify the role of radiotherapy with ipilimumab, but these encouraging preliminary observations suggest that this combination can induce more durable responses to immunotherapy.

  12. A phase 2 autologous cellular therapy trial in patients with acute, complete spinal cord injury: pragmatics, recruitment, and demographics.

    Science.gov (United States)

    Jones, L A T; Lammertse, D P; Charlifue, S B; Kirshblum, S C; Apple, D F; Ragnarsson, K T; Poonian, D; Betz, R R; Knoller, N; Heary, R F; Choudhri, T F; Jenkins, A L; Falci, S P; Snyder, D A

    2010-11-01

    Post hoc analysis from a randomized controlled cellular therapy trial in acute, complete spinal cord injury (SCI). Description and quantitative review of study logistics, referral patterns, current practice patterns and subject demographics. Subjects were recruited to one of six international study centers. Data are presented from 1816 patients pre-screened, 75 participants screened and 50 randomized. Of the 1816 patients pre-screened, 53.7% did not meet initial study criteria, primarily due to an injury outside the time window (14 days) or failure to meet neurological criteria (complete SCI between C5 motor/C4 sensory and T11). MRIs were obtained on 339 patients; 51.0% were ineligible based on imaging criteria. Of the 75 participants enrolled, 25 failed screening (SF), leaving 50 randomized. The primary reason for SF was based on the neurological exam (51.9%), followed by failure to meet MRI criteria (22.2%). Of the 50 randomized subjects, there were no significant differences in demographics in the active versus control arms. In those participants for whom data was available, 93.8% (45 of 48) of randomized participants received steroids before study entry, whereas 94.0% (47 of 50) had spine surgery before study enrollment. The 'funnel effect' (large numbers of potentially eligible participants with a small number enrolled) impacts all trials, but was particularly challenging in this trial due to eligibility criteria and logistics. Data collected may provide information on current practice patterns and the issues encountered and addressed may facilitate design of future trials.

  13. Completion pancreatectomy and islet cell autotransplantation as salvage therapy for patients failing previous operative interventions for chronic pancreatitis.

    Science.gov (United States)

    Wilson, Gregory C; Sutton, Jeffrey M; Smith, Milton T; Schmulewitz, Nathan; Salehi, Marzieh; Choe, Kyuran A; Levinsky, Nick C; Brunner, John E; Abbott, Daniel E; Sussman, Jeffrey J; Edwards, Michael J; Ahmad, Syed A

    2015-10-01

    Traditional decompressive and/or pancreatic resection procedures have been the cornerstone of operative therapy for refractory abdominal pain secondary to chronic pancreatitis. Management of patients that fail these traditional interventions represents a clinical dilemma. Salvage therapy with completion pancreatectomy and islet cell autotransplantation (CPIAT) is an emerging treatment option for this patient population; however, outcomes after this procedure have not been well-studied. All patients undergoing CPIAT after previous decompressive and/or pancreatic resection for the treatment of chronic pancreatitis at our institution were identified for inclusion in this single-center observational study. Study end points included islet yield, narcotic requirements, glycemic control, and quality of life (QOL). QOL was assessed using the Short Form (SF)-36 health questionnaire. Sixty-four patients underwent CPIAT as salvage therapy. The median age at time of CPIAT was 38 years (interquartile range [IQR], 14.7-65.4). The most common etiology of chronic pancreatitis was idiopathic pancreatitis (66%; n = 42) followed by genetically linked pancreatitis (9%; n = 6) and alcoholic pancreatitis (8%; n = 5). All of these patients had previously undergone prior limited pancreatic resection or decompressive procedure. The majority of patients (50%; n = 32) underwent prior pancreaticoduodenectomy, whereas the remainder had undergone distal pancreatectomy (17%; n = 11), Frey (13%; n = 8), Puestow (13%; n = 8), or Berne (8%; n = 5) procedures. Median time from initial surgical intervention to CPIAT was 28.1 months (IQR, 13.6-43.0). All of these patients underwent a successful CPIAT. Mean operative time was 502.2 minutes with average hospital duration of stay of 13 days. Islet cell isolation was feasible despite previous procedures with a mean islet yield of 331,304 islet cell equivalents, which totaled an islet cell autotransplantation of 4,737 ± 492 IEQ/kg body weight. Median

  14. MMP9 but Not EGFR, MET, ERCC1, P16, and P-53 Is Associated with Response to Concomitant Radiotherapy, Cetuximab, and Weekly Cisplatin in Patients with Locally Advanced Head and Neck Cancer

    Directory of Open Access Journals (Sweden)

    George Fountzilas

    2009-01-01

    Full Text Available Concomitant administration of radiotherapy with cisplatin or radiotherapy with cetuximab appear to be the treatment of choice for patients with locally advanced head and neck cancer. In the present retrospective analysis, we investigated the predictive role of several biomarkers in an unselected cohort of patients treated with concomitant radiotherapy, weekly cisplatin, and cetuximab (CCRT. We identified 37 patients treated with this approach, of which 13 (35% achieved a complete response and 10 (27% achieved a partial response. Severe side effects were mainly leucopenia, dysphagia, rash, and anemia. Tumor EGFR, MET, ERCC1, and p-53 protein and/or gene expression were not associated with treatment response. In contrast, high MMP9 mRNA expression was found to be significantly associated with objective response. In conclusion, CCRT is feasible and active. MMP9 was the only biomarker tested that appears to be of predictive value in cetuximab treated patients. However, this is a hypothesis generating study and the results should not be viewed as definitive evidence until they are validated in a larger cohort.

  15. Complete Remodeling After Conservative Treatment of a Severely Angulated Odontoid Fracture in a Patient With Osteogenesis Imperfecta: A Case Report.

    Science.gov (United States)

    Colo, Dino; Schlösser, Tom P C; Oostenbroek, Hubert J; Castelein, René M

    2015-09-15

    Case report. This is the first case report describing successful healing and remodeling of a traumatic odontoid fracture that was dislocated and severely angulated in a patient with osteogenesis imperfecta who was treated conservatively. Osteogenesis imperfecta (OI) is a rare genetic disorder resulting in a low bone mass and bone fragility, predisposing these patients to fractures that often occur at a young age. Although any bone in the body may be involved, odontoid fractures are uncommon in this population. Because of a very high fusion rate, conservative management is accepted as a safe and efficient treatment of fractures of the odontoid in children. Several authors, however, recommend surgical treatment of patients who have failure of conservative treatment and have severe angulation or displacement of the odontoid. A 5-year-old female, diagnosed with OI type I, presented with neck pain without any neurological deficits after falling out of a rocking chair backward, with her head landing first on the ground. Computed tomography confirmed a type III odontoid fracture without dislocation and she was initially treated with a rigid cervical orthosis. At 1 and 2 months of follow-up, progressive severe angulation of the odontoid was observed but conservative treatment was maintained as the space available for the spinal cord was sufficient and also considering the patient's history of OI. Eight months postinjury, she had no clinical symptoms and there was osseous healing of the fracture with remodeling of the odontoid to normal morphology. Even in patients with OI, severely angulated odontoid fractures might have the capacity for osseous healing and complete remodeling under conservative treatment. 5.

  16. A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients

    Directory of Open Access Journals (Sweden)

    Yu Sue

    2008-09-01

    Full Text Available Abstract Background Lumiracoxib is a selective cyclooxygenase-2 inhibitor effective in the treatment of osteoarthritis (OA with a superior gastrointestinal (GI safety profile as compared to traditional non-steroidal anti-inflammatory drugs (NSAIDs, ibuprofen and naproxen. This safety study compared the GI tolerability, the blood pressure (BP profile and the incidence of oedema with lumiracoxib and rofecoxib in the treatment of OA. Rofecoxib was withdrawn worldwide due to an associated increased risk of CV events and lumiracoxib has been withdrawn from Australia, Canada, Europe and a few other countries following reports of suspected adverse liver reactions. Methods This randomised, double-blind study enrolled 309 patients (aged greater than or equal to 50 years with primary OA across 51 centres in Europe. Patients were randomly allocated to receive either lumiracoxib 400 mg od (four times the recommended dose in OA (n = 154 or rofecoxib 25 mg od (n = 155. The study was conducted for 6 weeks and assessments were performed at Weeks 3 and 6. The primary safety measures were the incidence of predefined GI adverse events (AEs and peripheral oedema. The secondary safety measures included effect of treatment on the mean sitting systolic and diastolic blood pressure (msSBP and msDBP. Tolerability of lumiracoxib 400 mg was assessed by the incidence of AEs. Results Lumiracoxib and rofecoxib displayed similar GI safety profiles with no statistically significant difference in predefined GI AEs between the two groups (43.5% vs. 37.4%, respectively. The incidence and severity of individual predefined GI AEs was comparable between the two groups. The incidence of peripheral oedema was low and identical in both the groups (n = 9, 5.8%. Only one patient in the lumiracoxib group and three patients in the rofecoxib group had a moderate or severe event. At Week 6 there was a significantly lower msSBP and msDBP in the lumiracoxib group compared to the rofecoxib

  17. Evaluation of third treatment week as temporal window for assessing responsiveness on repeated FDG-PET-CT scans in Non-Small Cell Lung Cancer patients.

    Science.gov (United States)

    Lazzeroni, M; Uhrdin, J; Carvalho, S; van Elmpt, W; Lambin, P; Dasu, A; Wersäll, P; Toma-Dasu, I

    2018-02-01

    Early assessment of tumour response to treatment with repeated FDG-PET-CT imaging has potential for treatment adaptation but it is unclear what the optimal time window for this evaluation is. Previous studies indicate that changes in SUV mean and the effective radiosensitivity (α eff , accounting for uptake variations and accumulated dose until the second FDG-PET-CT scan) are predictive of 2-year overall survival (OS) when imaging is performed before radiotherapy and during the second week. This study aims to investigate if multiple FDG-PET-derived quantities determined during the third treatment week have stronger predictive power. Twenty-eight lung cancer patients were imaged with FDG-PET-CT before radiotherapy (PET1) and during the third week (PET2). SUV mean , SUV max , SUV peak , MTV41%-50% (Metabolic Tumour Volume), TLG41%-50% (Total Lesion Glycolysis) in PET1 and PET2 and their change (), as well as average α eff (α¯ eff ) and the negative fraction of α eff values [Formula: see text] ) were determined. Correlations were sought between FDG-PET-derived quantities and OS with ROC analysis. Neither SUV mean , SUV max , SUV peak in PET1 and PET2 (AUC = 0.5-0.6), nor their changes (AUC = 0.5-0.6) were significant for outcome prediction purposes. Lack of correlation with OS was also found for α¯ eff (AUC = 0.5) and [Formula: see text] (AUC = 0.5). Threshold-based quantities (MTV41%-50%, TLG41%-50%) and their changes had AUC = 0.5-0.7. P-values were in all cases ≫0.05. The poor OS predictive power of the quantities determined from repeated FDG-PET-CT images indicates that the third week of treatment might not be suitable for treatment response assessment. Comparatively, the second week during the treatment appears to be a better time window. Copyright © 2018 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  18. Using Flow Characteristics in Three-Dimensional Power Doppler Ultrasound Imaging to Predict Complete Responses in Patients Undergoing Neoadjuvant Chemotherapy.

    Science.gov (United States)

    Shia, Wei-Chung; Huang, Yu-Len; Wu, Hwa-Koon; Chen, Dar-Ren

    2017-05-01

    Strategies are needed for the identification of a poor response to treatment and determination of appropriate chemotherapy strategies for patients in the early stages of neoadjuvant chemotherapy for breast cancer. We hypothesize that power Doppler ultrasound imaging can provide useful information on predicting response to neoadjuvant chemotherapy. The solid directional flow of vessels in breast tumors was used as a marker of pathologic complete responses (pCR) in patients undergoing neoadjuvant chemotherapy. Thirty-one breast cancer patients who received neoadjuvant chemotherapy and had tumors of 2 to 5 cm were recruited. Three-dimensional power Doppler ultrasound with high-definition flow imaging technology was used to acquire the indices of tumor blood flow/volume, and the chemotherapy response prediction was established, followed by support vector machine classification. The accuracy of pCR prediction before the first chemotherapy treatment was 83.87% (area under the ROC curve [AUC] = 0.6957). After the second chemotherapy treatment, the accuracy of was 87.9% (AUC = 0.756). Trend analysis showed that good and poor responders exhibited different trends in vascular flow during chemotherapy. This preliminary study demonstrates the feasibility of using the vascular flow in breast tumors to predict chemotherapeutic efficacy. © 2017 by the American Institute of Ultrasound in Medicine.

  19. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety

    Directory of Open Access Journals (Sweden)

    Teicher Martin H

    2009-12-01

    Full Text Available Abstract Background Many studies have reported beneficial effects from the application of near-infrared (NIR light photobiomodulation (PBM to the body, and one group has reported beneficial effects applying it to the brain in stroke patients. We have reported that the measurement of a patient's left and right hemispheric emotional valence (HEV may clarify data and guide lateralized treatments. We sought to test whether a NIR treatment could 1. improve the psychological status of patients, 2. show a relationship between immediate psychological improvements when HEV was taken into account, and 3. show an increase in frontal pole regional cerebral blood flow (rCBF, and 4. be applied without side effects. Methods We gave 10 patients, (5 M/5 F with major depression, including 9 with anxiety, 7 with a past history of substance abuse (6 with an opiate abuse and 1 with an alcohol abuse history, and 3 with post traumatic stress disorder, a baseline standard diagnostic interview, a Hamilton Depression Rating Scale (HAM-D, a Hamilton Anxiety Rating Scale (HAM-A, and a Positive and Negative Affect Scale (PANAS. We then gave four 4-minute treatments in a random order: NIR to left forehead at F3, to right forehead at F4, and placebo treatments (light off at the same sites. Immediately following each treatment we repeated the PANAS, and at 2-weeks and at 4-weeks post treatment we repeated all 3 rating scales. During all treatments we recorded total hemoglobin (cHb, as a measure of rCBF with a commercial NIR spectroscopy device over the left and the right frontal poles of the brain. Results At 2-weeks post treatment 6 of 10 patients had a remission (a score ≤ 10 on the HAM-D and 7 of 10 achieved this on the HAM-A. Patients experienced highly significant reductions in both HAM-D and HAM-A scores following treatment, with the greatest reductions occurring at 2 weeks. Mean rCBF across hemispheres increased from 0.011 units in the off condition to 0.043 units in

  20. A naturalistic multicenter trial of a 12-week weight management program for overweight and obese patients with schizophrenia or schizoaffective disorder.

    Science.gov (United States)

    Lee, Seung Jae; Choi, Eun Ju; Kwon, Jun Soo

    2008-04-01

    The primary aim of this study was to examine the efficacy and feasibility of a weight control program for overweight and obese patients with schizophrenia or schizoaffective disorder using a large sample across various clinical settings. Psychiatric patients taking antipsychotics participated in a 12-week weight management program at 33 clinical centers across South Korea, and the data for 232 subjects who had a body mass index (BMI) 25 kg/m(2) or above and were diagnosed with DSM-IV schizophrenia or schizoaffective disorder were used in the final analysis. The primary measures of efficacy were changes in body weight and BMI. The study was conducted from December 2005 to July 2006. These patients showed significant mean +/- SD reductions in BMI (0.98 +/- 1.01 kg/m(2), p weight loss. Although significant differences in BMI reduction occurred between groups classified by clinical setting and compliance, all sex, age, clinical setting, compliance, and initial BMI groups showed significant BMI reductions, which fell between 0.4 and 1.5 kg/m(2). Overall results suggest that a weight management program may be disseminated and adopted by practitioners across settings, resulting in short-term weight loss in schizophrenic and schizoaffective patients.

  1. Efficacy and safety of sacubitril/valsartan in patients with essential hypertension uncontrolled by olmesartan: A randomized, double-blind, 8-week study.

    Science.gov (United States)

    Cheung, Deanna G; Aizenberg, Diego; Gorbunov, Vladimir; Hafeez, Kudsia; Chen, Chien-Wei; Zhang, Jack

    2018-01-01

    A majority of patients with hypertension fail to achieve blood pressure (BP) control despite treatment with commonly prescribed drugs. This randomized, double-blind phase III trial assessed the superiority of sacubitril/valsartan 200 mg (97/103 mg) to continued olmesartan 20 mg in reducing ambulatory systolic BP after 8-week treatment in patients with mild to moderate essential hypertension uncontrolled with olmesartan 20 mg alone. A total of 376 patients were randomized to receive either sacubitril/valsartan (n = 188) or olmesartan (n = 188). Superior reductions in 24-hour mean ambulatory systolic BP were observed in the sacubitril/valsartan group vs the olmesartan group (-4.3 mm Hg vs -1.1 mm Hg, P sacubitril/valsartan vs olmesartan (P sacubitril/valsartan vs olmesartan. The overall incidence of adverse events was comparable between the groups. Compared with continued olmesartan, sacubitril/valsartan was more effective and generally safe in patients with hypertension uncontrolled with olmesartan 20 mg. ©2018 Wiley Periodicals, Inc.

  2. The Active Metabolite of Warfarin (3'-Hydroxywarfarin) and Correlation with INR, Warfarin and Drug Weekly Dosage in Patients under Oral Anticoagulant Therapy: A Pharmacogenetics Study.

    Science.gov (United States)

    Gemmati, Donato; Burini, Francesco; Talarico, Anna; Fabbri, Matteo; Bertocco, Cesare; Vigliano, Marco; Moratelli, Stefano; Cuneo, Antonio; Serino, Maria Luisa; Avato, Francesco Maria; Tisato, Veronica; Gaudio, Rosa Maria

    2016-01-01

    Warfarin oral anticoagulant therapy (OAT) requires regular and frequent drug adjustment monitored by INR. Interindividual variability, drug and diet interferences, and genetics (VKORC1 and CYP2C9) make the maintenance/reaching of stable INR a not so easy task. HPLC assessment of warfarin/enantiomers was suggested as a valid monitoring-tool along with INR, but definite results are still lacking. We evaluated possible correlations between INR, warfarin/3'-hydroxywarfarin, and drug weekly dosage aimed at searching novel alternatives to OAT monitoring. VKORC1/CYP2C9 pharmacogenetics investigation was performed to account for the known influence on warfarin homeostasis. 133 OAT patients were recruited and assessed for warfarin/3'-hydroxywarfarin serum levels (HPLC), INR, and VKORC1 and CYP2C9 genotypes. A subgroup of 52 patients were monitored in detail (5 consecutive controls; c0-c4) till the target INR was reached. Correlation analyses were performed in both groups. In the whole OAT group both warfarin and 3'-hydroxywarfarin correlate with INR at comparable degree (r2 = 0.0388 and 0.0362 respectively). Conversely, warfarin weekly dosage better correlates with warfarin than with 3'-hydroxywarfarin (r2 = 0.0975 and r2 = 0.0381 respectively), but considering together warfarin plus 3'-hydroxywarfarin the correlation strongly increased (r2 = 0.1114; ppharmacogenetics studies confirmed that patients carrying the VKORC1 variant-allele required lower warfarin maintenance dosage and that the combination of VKORC1 and CYP2C9 yielded a warfarin responsive index (WRI) inversely related to the number variant alleles. Our results overall suggest that 3'-hydroxywarfarin monitoring could be of great advantage in INR monitoring respect to classical warfarin assessment showing significant contribution also in multivariate analysis. Therefore, additional active metabolites should be recognized and investigated as novel useful indicators.

  3. Radiation dose reduction for patients with extranodal NK/T-cell lymphoma with complete response after initial induction chemotherapy

    Directory of Open Access Journals (Sweden)

    Wang L

    2016-09-01

    Full Text Available Liang Wang,1,2,* Xi-wen Bi,1,3,* Zhong-jun Xia,1,2 Hui-qiang Huang,1,3 Wen-qi Jiang,1,3 Yu-jing Zhang1,4 1State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, 2Department of Hematologic Oncology, 3Department of Medical Oncology, 4Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China *These authors contributed equally to this work Abstract: Previous studies have found that radiotherapy (RT dose less than 50 Gy resulted in inferior outcomes for early stage extranodal NK/T-cell lymphoma (ENKTL. Nowadays, induction chemotherapy (CT followed by RT consolidation is often used. For patients who get complete response (CR after CT, whether RT dose can be safely reduced or not remains unknown. This retrospective study compared the survival outcomes between patients who received higher dose (>50 Gy and lower dose (≤50 Gy RT after CR was attained by CT. One hundred and forty four patients of early stage ENKTL got CR after induction CT and received RT consolidation. Thirty-one patients received lower dose RT (median 46 Gy, range, 36–50 Gy, and 113 patients received higher dose RT (median 56 Gy, range, 52–66 Gy. In univariate survival analysis, age >60, local tumor invasion, and non-asparaginase-based CT were associated with inferior progression-free survival (PFS and overall survival (OS. However, there were no differences in PFS and OS between patients treated with higher and lower dose RT, which was confirmed in the multivariate survival analysis. Furthermore, reduced dose RT did not affect local control rate. Most common RT-related side effects were grade 1/2 mucositis and dermatitis, and the incidence rate of grade 3 mucositis or dermatitis was lower in patients treated with reduced dose RT (9.7% vs 15.0% for mucositis, and 6.5% vs 17.7% for dermatitis. In conclusion, this study found that RT dose could be safely reduced without

  4. Leukaemic infiltration and cytomegalovirus retinitis in a patient with acute T-cell lymphoblastic leukaemia in complete remission.

    Science.gov (United States)

    Saldaña Garrido, J D; Martínez Rubio, M; Carrión Campo, R; Moya Moya, M A; Rico Sergado, L

    2017-03-01

    A 43-year-old woman in remission from T- cell acute lymphoblastic leukaemia was referred to our hospital with suspected leukaemic retinitis. The funduscopic examination of her left eye revealed multifocal yellow-white peripheral retinitis and retinal haemorrhage. The patient was treated for cytomegalovirus retinitis after an extended haematological investigation showed no abnormalities. Initial improvement was followed by papillitis in the left eye and motility restriction in the right eye. Magnetic resonance and lumbar puncture confirmed leukaemia relapse. Specific treatment was initiated with complete resolution. Ocular involvement may precede haematological leukaemia relapse. Physicians should be alerted when ocular symptoms appear in these cases. Copyright © 2016 Sociedad Española de Oftalmología. Publicado por Elsevier España, S.L.U. All rights reserved.

  5. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer.

    Science.gov (United States)

    Moreno, Lucas; Casanova, Michela; Chisholm, Julia C; Berlanga, Pablo; Chastagner, Pascal B; Baruchel, Sylvain; Amoroso, Loredana; Melcón, Soledad Gallego; Gerber, Nicolas U; Bisogno, Gianni; Fagioli, Franca; Geoerger, Birgit; Glade Bender, Julia L; Aerts, Isabelle; Bergeron, Christophe; Hingorani, Pooja; Elias, Ileana; Simcock, Mathew; Ferrara, Stefano; Le Bruchec, Yvan; Slepetis, Ruta; Chen, Nianhang; Vassal, Gilles

    2018-06-21

    nab-Paclitaxel has demonstrated efficacy in adults with solid tumours and preclinical activity in paediatric solid tumour models. Results from phase I of a phase I/II study in paediatric patients with recurrent/refractory solid tumours treated with nab-paclitaxel are reported. Patients with recurrent/refractory extracranial solid tumours received nab-paclitaxel on days 1, 8 and 15 every 4 weeks at 120, 150, 180, 210, 240, or 270 mg/m 2 (rolling-6 dose-escalation) to establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D). Sixty-four patients were treated. Dose-limiting toxicities were grade 3 dizziness at 120 mg/m 2 and grade 4 neutropenia >7 days at 270 mg/m 2 . The most frequent grade 3/4 adverse events were haematologic, including neutropenia (36%), leukopenia (36%) and lymphopenia (25%). Although the MTD was not reached, 270 mg/m 2 was declared non-tolerable due to grade 3/4 toxicities during cycles 1-2 (neutropenia, n = 5/7; skin toxicity, n = 2/7; peripheral neuropathy, n = 1/7). Of 58 efficacy-evaluable patients, complete response occurred in one patient (2%; Ewing sarcoma) and partial responses in four patients (7%; rhabdomyosarcoma, Ewing sarcoma, renal tumour with pulmonary metastases [high-grade, malignant] and sarcoma not otherwise specified); all responses occurred at ≥210 mg/m 2 . Thirteen patients (22%) had stable disease (5 lasting ≥16 weeks) per RECIST. nab-Paclitaxel 240 mg/m 2 qw3/4 (nearly double the adult recommended monotherapy dose for this schedule in metastatic breast cancer) was selected as the RP2D based on the tolerability profile, pharmacokinetics and antitumour activity. Phase II is currently enrolling patients with recurrent/refractory neuroblastoma, rhabdomyosarcoma and Ewing sarcoma. CLINICALTRIALS.GOV: NCT01962103. 2013-000144-26. Copyright © 2018 Elsevier Ltd. All rights reserved.

  6. Digital versus analog complete-arch impressions for single-unit premolar implant crowns: Operating time and patient preference.

    Science.gov (United States)

    Schepke, Ulf; Meijer, Henny J A; Kerdijk, Wouter; Cune, Marco S

    2015-09-01

    Digital impression-making techniques are supposedly more patient friendly and less time-consuming than analog techniques, but evidence is lacking to substantiate this assumption. The purpose of this in vivo within-subject comparison study was to examine patient perception and time consumption for 2 complete-arch impression-making methods: a digital and an analog technique. Fifty participants with a single missing premolar were included. Treatment consisted of implant therapy. Three months after implant placement, complete-arch digital (Cerec Omnicam; Sirona) and analog impressions (semi-individual tray, Impregum; 3M ESPE) were made, and the participant's opinion was evaluated with a standard questionnaire addressing several domains (inconvenience, shortness of breath, fear of repeating the impression, and feelings of helplessness during the procedure) with the visual analog scale. All participants were asked which procedure they preferred. Operating time was measured with a stopwatch. The differences between impressions made for maxillary and mandibular implants were also compared. The data were analyzed with paired and independent sample t tests, and effect sizes were calculated. Statistically significant differences were found in favor of the digital procedure regarding all subjective domains (P<.001), with medium to large effect sizes. Of all the participants, over 80% preferred the digital procedure to the analog procedure. The mean duration of digital impression making was 6 minutes and 39 seconds (SD=1:51) versus 12 minutes and 13 seconds (SD=1:24) for the analog impression (P<.001, effect size=2.7). Digital impression making for the restoration of a single implant crown takes less time than analog impression making. Furthermore, participants preferred the digital scan and reported less inconvenience, less shortness of breath, less fear of repeating the impression, and fewer feelings of helplessness during the procedure. Copyright © 2015 Editorial Council

  7. Frontal-subcortical volumetric deficits in single episode, medication-naïve depressed patients and the effects of 8 weeks fluoxetine treatment: a VBM-DARTEL study.

    Directory of Open Access Journals (Sweden)

    Lingtao Kong

    Full Text Available BACKGROUND: Convergent studies suggest that morphological abnormalities of frontal-subcortical circuits which involved with emotional and cognitive processing may contribute to the pathophysiology of major depressive disorder (MDD. Antidepressant treatment which has been reported to reverse the functional abnormalities of frontal-subcortical circuits in MDD may have treating effects to related brain morphological abnormalities. In this study, we used voxel-based morphometry method to investigate whole brain structural abnormalities in single episode, medication-naïve MDD patients. Furthermore, we investigated the effects of an 8 weeks pharmacotherapy with fluoxetine. METHODS: 28 single episode, medication-naïve MDD participants and 28 healthy controls (HC acquired the baseline high-resolution structural magnetic resonance imaging (sMRI scan. 24 MDD participants acquired a follow-up sMRI scan after 8 weeks antidepressant treatment. Gray matter volumetric (GMV difference between groups was examined. RESULTS: Medication-naïve MDD had significantly decreased GMV in the right dorsolateral prefrontal cortex and left middle frontal gyrus as well as increased GMV in the left thalamus and right insula compared to HC (P<0.05, corrected. Moreover, treated MDD had significantly increased GMV in the left middle frontal gyrus and right orbitofrontal cortex compared to HC (P<0.05, corrected. No difference on GMV was detected between medication-naïve MDD group and treated MDD group. CONCLUSIONS: This study of single episode, medication-naïve MDD subjects demonstrated structural abnormalities of frontal-subcortical circuitsin the early stage of MDD and the effects of 8 weeks successful antidepressant treatment, suggesting these abnormalities may play an important role in the neuropathophysiology of MDD at its onset.

  8. Changes in body weight after 24 weeks of vildagliptin therapy as a function of fasting glucose levels in patients with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Blüher M

    2014-11-01

    Full Text Available Matthias Blüher,1 Anja Schweizer,2 Giovanni Bader,2 James E Foley3 1Department of Medicine, University of Leipzig, Leipzig, Germany; 2Novartis Pharma AG, Basel, Switzerland; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Background: In order to test the hypothesis that the degree of weight change with the dipeptidyl peptidase-4 inhibitor vildagliptin is dependent on the level of glycemic control at baseline, the weight changes from pooled monotherapy studies after 24 weeks of therapy with vildagliptin were assessed versus the fasting plasma glucose (FPG levels at baseline. Methods: Data were pooled from eight clinical monotherapy trials including 2,340 previously drug-naïve patients with type 2 diabetes mellitus who received vildagliptin monotherapy (50 mg once daily [n=359] or 50 mg twice daily [n=1,981]. The trials were all randomized, double-blind, controlled clinical trials with a prespecified week 24 study visit. Results: Linear regression analysis of weight change after 24 weeks relative to baseline FPG showed an intercept of −2.259 kg (95% confidence interval −2.86, −1.66; P<0.0001 and a positive slope of 0.1552 kg (95% confidence interval 0.10–0.21; P<0.0001. Neutral caloric balance (no weight change was observed at a FPG of 14.6 mmol/L (263 mg/dL. Baseline FPG values below and above this threshold were associated with weight loss and weight gain, respectively. For instance, from this analysis, a baseline FPG of 8 mmol/L (144 mg/dL predicts a weight loss of 1 kg. Conclusion: The present analysis showed that treatment with vildagliptin results in a negative caloric balance when glucose levels are below the renal threshold at baseline. Keywords: dipeptidyl peptidase-4 inhibitor, glucagon-like peptide-1, renal threshold, sodium-glucose cotransporter-2 inhibitor, hyperglycemia

  9. Complete oral rehabilitation of a deep bite patient with Ewing’s sarcoma; surgical and prosthetic phases: A clinical report

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    Mehran Bahrami

    2017-01-01

    Full Text Available Introduction: Ewings sarcoma (ES is an unusual, aggressive malignant neoplasm occurring primarily in the long bones of the lower and upper extremities followed by pelvis, ribs, vertebrae, skull, and jaws-bones. Patients with ES tumor need long-term complete oral reconstruction. The location of the primary tumor in the face is predominantly in the mandible, and usually in the posterior mandible. Case Report: Here, both surgical procedures and prosthetic reconstruction in three stages of a 10-year-old childs life presented. Definitive prosthetic reconstruction is extremely challenging in such patients after previous excessive surgical resection, especially when the patient has complex dental abnormality. Fixed dental prostheses and implant-supported fixed restorations have been selected as the preferred treatment option in this case after increasing occlusal vertical dimension (OVD to create sufficient interocclusal space (IOS. Discussion: In this case, ES patient treated in three phases. In the first-stage, only surgical resection of tumor and bone graft reconstruction with titanium plate fixation was performed. In the second-stage, Lefort I surgery for maxilla with dental implants insertion in mandible was done simultaneously. For definitive restorations fabrication, it was mandatory to increase occlusal vertical dimension (OVD to create sufficient inter-occlusal space (IOS for the restorations. OVD has been altered to achieve more stable relationship of mandibular teeth with maxillary teeth, and to obtain an optimum esthetic and functional result. Several factors should be considered as determinants for increasing the OVD such as remaining tooth structure, the space available for the restorations such as the current situation, occlusal variables, and esthetics.

  10. Complete response in a patient with gynecological hidradenocarcinoma treated with exclusive external beam radiotherapy and brachytherapy: a case report.

    Science.gov (United States)

    Giannelli, Flavio; Chiola, Ilaria; Belgioia, Liliana; Garelli, Stefania; Pastorino, Alice; Marcenaro, Michela; Mammoliti, Serafina; Costantini, Sergio; Bizzarri, Nicolò; Vellone, Valerio; Barra, Salvina; Corvò, Renzo

    2017-12-01

    Hidradenocarcinoma (HC) is a very rare disease. This case report illustrates a successful treatment of a 60-year-old woman with vulvo-vaginal localization of hidradenocarcinoma treated with external beam radiotherapy delivered by helical tomotherapy with a simultaneous integrated boost (SIB), followed by brachytherapy. External beam radiotherapy dose prescription was 50.4 Gy in 28 fractions, five fractions per week to whole pelvis (planning target volume 1 - PTV1), 60.2 Gy in 28 fractions to SIB1 (fundus of uterus and right inguinal node), and 58.8 Gy in 28 fractions to SIB2 (lower/middle third of vagina, paraurethral region and right inguinal lymph nodes). Brachytherapy dose prescription was 28 Gy in 4 fractions for cervix, fundus of uterus and upper third of vagina (HR-CTV1), and 22 Gy in 4 fractions to middle third of vagina and paraurethral region (HR-CTV2). D 90 for whole treatment was 91.9 Gy and 86.0 Gy for HR-CTV1 and HR-CTV2, respectively. Patient remained 12-months disease-free without treatment related side effects.

  11. Complete response in a patient with gynecological hidradenocarcinoma treated with exclusive external beam radiotherapy and brachytherapy: a case report

    Directory of Open Access Journals (Sweden)

    Flavio Giannelli

    2017-12-01

    Full Text Available Hidradenocarcinoma (HC is a very rare disease. This case report illustrates a successful treatment of a 60-year-old woman with vulvo-vaginal localization of hidradenocarcinoma treated with external beam radiotherapy delivered by helical tomotherapy with a simultaneous integrated boost (SIB, followed by brachytherapy. External beam radiotherapy dose prescription was 50.4 Gy in 28 fractions, five fractions per week to whole pelvis (planning target volume 1 – PTV1, 60.2 Gy in 28 fractions to SIB1 (fundus of uterus and right inguinal node, and 58.8 Gy in 28 fractions to SIB2 (lower/middle third of vagina, paraurethral region and right inguinal lymph nodes. Brachytherapy dose prescription was 28 Gy in 4 fractions for cervix, fundus of uterus and upper third of vagina (HR-CTV1, and 22 Gy in 4 fractions to middle third of vagina and paraurethral region (HR-CTV2. D90 for whole treatment was 91.9 Gy and 86.0 Gy for HR-CTV1 and HR-CTV2, respectively. Patient remained 12-months disease-free without treatment related side effects.

  12. Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan.

    Science.gov (United States)

    Mimori, Tsuneyo; Harigai, Masayoshi; Atsumi, Tatsuya; Fujii, Takao; Kuwana, Masataka; Matsuno, Hiroaki; Momohara, Shigeki; Takei, Syuji; Tamura, Naoto; Takasaki, Yoshinari; Ikeuchi, Satoshi; Kushimoto, Satoru; Koike, Takao

    2017-09-01

    To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.

  13. Twelve-Week Treatment With Liraglutide as Add-on to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes

    DEFF Research Database (Denmark)

    Frandsen, Christian S; Dejgaard, Thomas F; Holst, Jens J

    2015-01-01

    OBJECTIVE: This study investigated the efficacy and safety of once-daily liraglutide 1.2 mg versus placebo as add-on to insulin treatment in normal-weight patients with poorly controlled type 1 diabetes. RESEARCH DESIGN AND METHODS: In a randomized (1:1), double-blind, placebo-controlled design, 40...... patients with type 1 diabetes (HbA1c ≥8% [64 mmol/mol]) received once-daily liraglutide 1.2 mg or placebo for 12 weeks. Continuous glucose monitoring was performed before and at the end of treatment. The primary end point was change in HbA1c. Secondary end points included change in insulin dose, weight...... was more frequently associated with gastrointestinal adverse effects. The incidence of hypoglycemia did not differ between groups. CONCLUSIONS: Liraglutide significantly reduces body weight and insulin requirements but has no additional effect on HbA1c in normal-weight patients with type 1 diabetes...

  14. Weekly therapist ratings of the therapeutic relationship and patient introject during the course of dialectical behavioral therapy for the treatment of borderline personality disorder.

    Science.gov (United States)

    Bedics, Jamie D; Atkins, David C; Comtois, Katherine Anne; Linehan, Marsha M

    2012-06-01

    The purpose of the present study was to examine theory-driven hypotheses of the therapeutic relationship and patient introject in dialectical behavior therapy (DBT; Linehan, 1993) for the treatment of borderline personality disorder. A total of 14 DBT therapists provided weekly ratings of the therapeutic relationship and patient introject (N=41) during the course of a randomized controlled trial of DBT for the treatment of borderline personality disorder. Using hierarchical linear modeling (Raudenbush & Bryk, 2002), we tested four hypotheses of the therapeutic relationship as predicted by DBT and behavioral theory. Results supported three of our four predicted hypotheses of the therapeutic relationship, including the effective use of balancing autonomy and control in the therapeutic relationship, the importance of therapists' maintaining a nonpejorative stance toward the patient, and the use of therapist warmth and autonomy as a contingency for improved intrapsychic outcome. Results did not support a modeling hypothesis of the therapeutic relationship. The study supported a DBT and behavioral model of the therapeutic relationship from the perspective of the treating clinician. PsycINFO Database Record (c) 2012 APA, all rights reserved.

  15. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study.

    Science.gov (United States)

    Palomba, S; Giallauria, F; Falbo, A; Russo, T; Oppedisano, R; Tolino, A; Colao, A; Vigorito, C; Zullo, F; Orio, F

    2008-03-01

    Lifestyle modifications are successfully employed to treat obese and overweight women with polycystic ovary syndrome (PCOS). The aims of the current pilot study were (i) to compare the efficacy on reproductive functions of a structured exercise training (SET) programme with a diet programme in obese PCOS patients and (ii) to study their clinical, hormonal and metabolic effects to elucidate potentially different mechanisms of action. Forty obese PCOS patients with anovulatory infertility underwent a SET programme (SET group, n = 20) and a hypocaloric hyperproteic diet (diet group, n = 20). Clinical, hormonal and metabolic data were assessed at baseline, and at 12- and 24-week follow-ups. Primary endpoint was cumulative pregnancy rate. The two groups had similar demographic, anthropometric and biochemical parameters. After intervention, a significant improvement in menstrual cycles and fertility was noted in both groups, with no differences between groups. The frequency of menses and the ovulation rate were significantly (P diet group but the increased cumulative pregnancy rate was not significant. Body weight, body mass index, waist circumference, insulin resistance indexes and serum levels of sex hormone-binding globulin, androstenedione and dehydroepiandrosterone sulphate changed significantly (P diet interventions improve fertility in obese PCOS patients with anovulatory infertility. We hypothesize that in both interventions an improvement in insulin sensitivity is the pivotal factor involved in the restoration of ovarian function but potentially acting through different mechanisms.

  16. Increase in age is associated with worse outcomes in alveolar bone grafting in patients with bilateral complete cleft palate.

    Science.gov (United States)

    Calvo, Adriana Maria; Trindade-Suedam, Ivy Kiemle; da Silva Filho, Omar Gabriel; Carvalho, Roberta Martineli; de Souza Faco, Renato André; Ozawa, Terumi Okada; Cintra, Flávia; Trindade, Alceu Sergio; Trindade, Inge Elly Kiemle

    2014-03-01

    This prospective study aimed at evaluating the surgical outcomes of alveolar bone grafting (ABG) in subjects with bilateral cleft lip and palate treated at the Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil, by means of cone-beam computed tomography. Twenty-five patients with bilateral complete cleft lip and palate, resulting in 50 clefts, were analyzed. Subjects were divided into 2 groups according to the dentition status at the time of surgery: (1) SABG group: subjects with mixed dentition operated on before or immediately after eruption of the permanent canine (10-13 years); (2) TABG group: subjects with permanent dentition (15-23 years). Cone-beam computed tomography analysis was performed in the buccal, intermediate, and palatal views, 2 and 6 to 12 months postoperatively. In the SABG group, 96% of the grafts were classified as successful, and no failure cases were observed. In the TABG group, successful cases decreased to 65%, and failures were seen in 27% of the cleft sites. In both postoperative periods, significantly better outcomes (lower mean scores) were observed for the SABG group in all the cone-beam computed tomography views (P < 0.05). Results show that the timing of surgery is an important factor in determining the outcomes of ABG in patients with bilateral cleft lip and palate, with increasing age being associated with the worse outcomes.

  17. Increase in white cell and neutrophil counts during the first eighteen weeks of treatment with clozapine in patients admitted to a long-term psychiatric care inpatient unit.

    Science.gov (United States)

    Capllonch, Adrián; de Pablo, Silvia; de la Torre, Alberto; Morales, Ignacio

    Clozapine is an antipsychotic drug that has shown to be more effective than other antipsychotics in the treatment of schizophrenia, but its use is limited due to its side effects, particularly by the risk of causing agranulocytosis. A study was made on the variations in white cell and neutrophil counts in patients treated with clozapine in a Long-term Psychiatric Unit. A retrospective observational study was conducted with a sample of women of our long-term psychiatric care unit who had been treated with clozapine. A study was made on the variations in white cell and neutrophil counts during the first 18 weeks of treatment, as well as the onset of leukopenia, neutropenia, agranulocytosis, and the influence of concomitant drugs. The study included 55 patients on treatment with clozapine. The incidence rate of neutropenia was 1.82% (95% CI; 0.05-10.13). The incidence rate of leukopenia and agranulocytosis was 0%. An increase in white cell and neutrophil counts from baseline to week 3-4 was observed. Only small variations were observed after this time, but the counts remained higher than the initial values. These changes were statistically significant in the white cell count: One-way repeated ANOVA with Greenhouse-Geisser correction F (11.47, 37) = 2.114 (P= .011); and in neutrophils: One-way repeated ANOVA with Greenhouse-Geisser correction F (10.3, 37)=3.312 (P=.0002), and MANOVA F (18, 37)=2.693 (P=.005), ŋ 2 P =0.567. The influence of concomitant drugs (lithium, valproic and biperiden) was not significant on the overall increase found in white cells or neutrophils (MANOVA). Copyright © 2016 SEP y SEPB. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. Cyclic changes in gene expression induced by Peg-interferon alfa-2b plus ribavirin in peripheral blood monocytes (PBMC of hepatitis C patients during the first 10 weeks of treatment

    Directory of Open Access Journals (Sweden)

    Edenberg Howard J

    2008-11-01

    Full Text Available Abstract Background and Aims This study determined the kinetics of gene expression during the first 10 weeks of therapy with Pegylated-interferon-alfa2b (PegIntron™ and ribavirin (administered by weight in HCV patients and compared it with the recently completed Virahep C study 12 in which Peginterferon-alfa2a (Pegasys™ and ribavirin were administered. Methods RNA was isolated from peripheral blood monocytes (PBMC from twenty treatment-naïve patients just before treatment (day 1 and at days 3, 6, 10, 13, 27, 42 and 70 days after treatment. Gene expression at each time was measured using Affymetrix microarrays and compared to that of day 1. Results The expression of many genes differed significantly (p ≤ 0.001 and changed at least 1.5-fold at days 3 (290 probes and 10 (255 probes, but the number dropped at days 6 (165 and 13 (142. Most genes continued to be up regulated throughout the trial period. A second group of genes, including CXCL10, CMKLR1 (chemokine receptor 1, TRAIL, IL1Rα and genes associated with complement and lipid metabolism, was transiently induced early in treatment. CDKN1C (cyclin kinase inhibitor 1 was induced early but repressed at later times. Genes induced at later times were mostly related to blood chemistry and oxygen transport. By week 10, 11 of the patients demonstrated a positive response to therapy, and the final sustained viral response (SVR was 35%. The levels of gene induction or decrease was very similar to that previously reported with Pegasys/ribavirin treatment. Conclusion The response to Pegintron/ribavirin was similar to that reported for Pegasys/ribavirin despite some differences in the amount administered. We did not detect major differences at the genomic level between patients responding to treatment or non-responders, perhaps because of limited power. Gene induction occurred in a cyclic fashion, peaking right after administration of interferon and declining between administrations of the drug. Our

  19. Increase in IL-6 levels among major depressive disorder patients after a 6-week treatment with duloxetine 60 mg/day: a preliminary observation

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    Michele Fornaro

    2011-02-01

    Full Text Available Michele Fornaro1, Matteo Martino1, Florinda Battaglia2, Salvatore Colicchio3, Giulio Perugi41Department of Neuroscience, Section of Psychiatry, University of Genova, Genoa, Italy; 2Center of Excellence for Biomedical Research (CEBR, Genoa, Italy; 3Department of Neurosciences, Catholic University, Rome, Italy; 4Department of Psychiatry, Institute of Behavioral Sciences, University of Pisa, Pisa, ItalyBackground: Immune modifications, including changes in interleukin (IL-6 levels, have often been observed in major depressive disorder (MDD during treatment with selective serotonin reuptake inhibitors (SSRIs or the serotonin norepinephrine reuptake inhibitor (SNRI venlafaxine. Nevertheless, no equivalent observation for the SNRI duloxetine has been made to date.Method: Sixteen patients diagnosed with MDD and an actual major depressive episode according to DSM-IV criteria and 16 healthy controls entered a 6-week trial with duloxetine 60 mg/day. All subjects (n = 32 were assessed using the Hamilton Depression Rating Scale (HAM-D, the Young Mania Rating Scale (YMRS, and were monitored for IL-6 levels both at baseline and at week 6. Blood samples for IL-6 levels were evaluated by ELISA.Results: After 6 weeks of treatment, the mean total scores for HAM-D declined both in the depressed and control groups, while IL-6 modification showed an opposite trend both in depressed (12.38 ± 19.80 to 19.73 ± 18.94 pg/mL and control subjects (12.25 ± 21.12 to 17.63 ± 20.44 pg/mL, as did YMRS (ns, although none of the subjects switched to (hypomania. Of note, IL-6 levels increased significantly only in the responders subgroup (n = 9; P = 0.012.Conclusion: The small sample size and weak design of this study limit the validity of our results, which should be regarded as preliminary only. Nonetheless, the trend of increasing IL-6 levels observed in responder patients treated with duloxetine should prompt further controlled, extended studies with larger samples, with

  20. Rare emergence of drug resistance in HIV-1 treatment-naïve patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks.

    Science.gov (United States)

    Margot, Nicolas; Cox, Stephanie; Das, Moupali; McCallister, Scott; Miller, Michael D; Callebaut, Christian

    2018-06-01

    The single tablet regimen (STR) composed of elvitegravir (E), cobicistat (C), emtricitabine (F), and tenofovir alafenamide (TAF) (E/C/F/TAF) was compared to the STR composed of E, C, F, and tenofovir disoproxil fumarate (TDF) (E/C/F/TDF) in 2 phase 3 studies in 1733 HIV-1 infected treatment-naïve adults. Superior efficacy of E/C/F/TAF compared to E/C/F/TDF was demonstrated at Week 144 with 84% treatment success compared to 80%, respectively, along with significantly better outcomes of bone and renal safety. Analyze the emergence of HIV-1 resistance in treatment-naïve adults receiving E/C/F/TAF for 144 weeks. We conducted an integrated resistance analysis of the 2 Phase 3 studies, comprising pretreatment HIV-1 sequencing for all participants (N = 1733) and post-baseline HIV-1 resistance analysis for participants with virologic failure (HIV-1 RNA ≥400 copies/mL). Primary resistance-associated mutations (RAMs) were observed pre-treatment in 7.4% (NRTI-RAMs), 18.1% (NNRTI-RAMs), and 3.3% (PI-RAMs) of enrolled subjects. Baseline HIV-1 subtype or pre-existing RAMs did not affect E/C/F/TAF treatment response at week 144. Virologic failure resistance analyses were conducted for 28/866 (3.2%) and 30/867 (3.5%) patients in the E/C/F/TAF and E/C/F/TDF arms, respectively. Over the 3-year study, the rate of resistance emergence remained low at 1.4% in each group (12/866 in E/C/F/TAF; 12/867 in E/C/F/TDF). Resistant virus emerged in 24 patients who developed resistance to antiretrovirals in the regimens (E/C/F/TAF: M184V/I [1.3%], INSTI-RAMs [0.9%], K65R/N [0.2%]; E/C/F/TDF: M184V/I [1.0%], INSTI-RAMs [0.9%], K65R/N [0.5%]). Resistance emergence was rare (1.4%) with similar patterns of emergent mutations in both groups. M184V/I was the most prevalent RAM (1.2% overall). Copyright © 2018 Elsevier B.V. All rights reserved.

  1. Comparison of concurrent chemoradiotherapy versus sequential radiochemotherapy in patients with completely resected non-small cell lung cancer

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    Kim, Hwan Ik; Noh, O Kyu; Oh, Young Taek; Chun, Mi Son; Kim, Sang Won; Cho, O Yeon; Heo, Jae Sung [Ajou University School of Medicine, Suwon (Korea, Republic of)

    2016-09-15

    Our institution has implemented two different adjuvant protocols in treating patients with non-small cell lung cancer (NSCLC): chemotherapy followed by concurrent chemoradiotherapy (CT-CCRT) and sequential postoperative radiotherapy (PORT) followed by postoperative chemotherapy (POCT). We aimed to compare the clinical outcomes between the two adjuvant protocols. From March 1997 to October 2012, 68 patients were treated with CT-CCRT (n = 25) and sequential PORT followed by POCT (RT-CT; n = 43). The CT-CCRT protocol consisted of 2 cycles of cisplatin-based POCT followed by PORT concurrently with 2 cycles of POCT. The RT-CT protocol consisted of PORT followed by 4 cycles of cisplatin-based POCT. PORT was administered using conventional fractionation with a dose of 50.4–60 Gy. We compared the outcomes between the two adjuvant protocols and analyzed the clinical factors affecting survivals. Median follow-up time was 43.9 months (range, 3.2 to 74.0 months), and the 5-year overall survival (OS), locoregional recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS) were 53.9%, 68.2%, and 51.0%, respectively. There were no significant differences in OS (p = 0.074), LRFS (p = 0.094), and DMFS (p = 0.490) between the two protocols. In multivariable analyses, adjuvant protocol remained as a significant prognostic factor for LRFS, favouring CT-CCRT (hazard ratio [HR] = 3.506, p = 0.046) over RT-CT, not for OS (HR = 0.647, p = 0.229). CT-CCRT protocol increased LRFS more than RT-CT protocol in patients with completely resected NSCLC, but not in OS. Further studies are warranted to evaluate the benefit of CCRT strategy compared with sequential strategy.

  2. The evaluation of an intervention based on the application of patient self-completion concordance forms in Dutch community pharmacies and the effect on adherence to chronic medication

    NARCIS (Netherlands)

    Geurts, Marlies M. E.; Pot, Johan L. W.; Schepers, Emiel H.; Tromp, Chris; Colijn, Corine G.; Dijkstra, Arie; de Gier, Johan J.

    Objective: To evaluate the use of patient self-completion concordance forms and to determine the effect of patient counselling by using concordance forms on adherence to chronic medication. Methods: Patients with a prescription for new chronic treatment were randomised in an intervention or control

  3. The Active Metabolite of Warfarin (3'-Hydroxywarfarin) and Correlation with INR, Warfarin and Drug Weekly Dosage in Patients under Oral Anticoagulant Therapy: A Pharmacogenetics Study

    Science.gov (United States)

    Talarico, Anna; Fabbri, Matteo; Bertocco, Cesare; Vigliano, Marco; Moratelli, Stefano; Cuneo, Antonio; Serino, Maria Luisa; Avato, Francesco Maria

    2016-01-01

    Objectives Warfarin oral anticoagulant therapy (OAT) requires regular and frequent drug adjustment monitored by INR. Interindividual variability, drug and diet interferences, and genetics (VKORC1 and CYP2C9) make the maintenance/reaching of stable INR a not so easy task. HPLC assessment of warfarin/enantiomers was suggested as a valid monitoring-tool along with INR, but definite results are still lacking. We evaluated possible correlations between INR, warfarin/3’-hydroxywarfarin, and drug weekly dosage aimed at searching novel alternatives to OAT monitoring. VKORC1/CYP2C9 pharmacogenetics investigation was performed to account for the known influence on warfarin homeostasis. Methods 133 OAT patients were recruited and assessed for warfarin/3’-hydroxywarfarin serum levels (HPLC), INR, and VKORC1 and CYP2C9 genotypes. A subgroup of 52 patients were monitored in detail (5 consecutive controls; c0-c4) till the target INR was reached. Correlation analyses were performed in both groups Results In the whole OAT group both warfarin and 3’-hydroxywarfarin correlate with INR at comparable degree (r2 = 0.0388 and 0.0362 respectively). Conversely, warfarin weekly dosage better correlates with warfarin than with 3’-hydroxywarfarin (r2 = 0.0975 and r2 = 0.0381 respectively), but considering together warfarin plus 3’-hydroxywarfarin the correlation strongly increased (r2 = 0.1114; pwarfarin (r2 = 0.2157 and r2 = 0.0549; p = 0.0005 and p = 0.0944 respectively) seeming less affected by drug adjustments in the subgroup of 52 patients who started OAT. The multivariate analyses aimed at estimating the true contribution of 3’-hydroxywarfarin on INR value ascribed it the unique significant value (p = 0.0021) in spite of warfarin who lost association. The pharmacogenetics studies confirmed that patients carrying the VKORC1 variant-allele required lower warfarin maintenance dosage and that the combination of VKORC1 and CYP2C9 yielded a warfarin responsive index (WRI

  4. Efficacy and Safety of Antiretroviral Therapy Initiated One Week after Tuberculosis Therapy in