Science.gov

Sample records for prospective non-randomized clinical

  1. Comparison of vaginal and abdominal hysterectomy:A prospective non-randomized trial

    PubMed Central

    Chen, Bing; Ren, Dong-Ping; Li, Jing-Xuan; Li, Chun-Dong

    2014-01-01

    Objective: To compare outcomes of vaginal and abdominal hysterectomy procedures in women with benign gynaecological diseases. Methods: This was a prospective study of outcomes of consecutive patients who underwent total vaginal hysterectomy (VH) or abdominal hysterectomy (AH) for benign gynaecological diseases. Patient characteristics before, during, and after the operations were reviewed. Patients were followed up for three months to evaluate postoperative complications. Results: This study included a total of 313 patients. 143 patients underwent AH and 170 patients underwent VH. Baseline characteristics were similar between the two groups. There were no intraoperative complications in either group. Operation time, intraoperative blood loss, first postoperative flatus time, time to out-of-bed activity, mean maximum postoperative body temperature, and duration of fever were all significantly shorter and less severe in the VH group compared with the AH group. In addition, vaginal length in the VH group was significantly shorter than in the AH group. Conclusions: Vaginal hysterectomy has advantages over AH in the treatment of benign gynaecological diseases, providing greater efficacy and safety with minimal invasiveness. PMID:25097536

  2. Cortical atrophy patterns in multiple sclerosis are non-random and clinically relevant.

    PubMed

    Steenwijk, Martijn D; Geurts, Jeroen J G; Daams, Marita; Tijms, Betty M; Wink, Alle Meije; Balk, Lisanne J; Tewarie, Prejaas K; Uitdehaag, Bernard M J; Barkhof, Frederik; Vrenken, Hugo; Pouwels, Petra J W

    2016-01-01

    of two cortical thickness patterns (bilateral sensorimotor cortex and bilateral insula), and global cortical thickness. The final model predicting average cognition (adjusted R(2) = 0.469; P < 0.001) consisted of age, the loadings of two cortical thickness patterns (bilateral posterior cingulate cortex and bilateral temporal pole), overall white matter lesion load and normal-appearing white matter integrity. Although white matter pathology measures were part of the final clinical regression models, they explained limited incremental variance (to a maximum of 4%). Several cortical atrophy patterns relevant for multiple sclerosis were found. This suggests that cortical atrophy in multiple sclerosis occurs largely in a non-random manner and develops (at least partly) according to distinct anatomical patterns. In addition, these cortical atrophy patterns showed stronger associations with clinical (especially cognitive) dysfunction than global cortical atrophy.

  3. Non-Randomized Confirmatory Trial of Laparoscopy-Assisted Total Gastrectomy and Proximal Gastrectomy with Nodal Dissection for Clinical Stage I Gastric Cancer: Japan Clinical Oncology Group Study JCOG1401

    PubMed Central

    Kataoka, Kozo; Mizusawa, Junki; Katayama, Hiroshi; Nakamura, Kenichi; Morita, Shinji; Yoshikawa, Takaki; Ito, Seiji; Kinoshita, Takahiro; Fukagawa, Takeo; Sasako, Mitsuru

    2016-01-01

    Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155. PMID:27433394

  4. Combining randomized and non-randomized evidence in clinical research: a review of methods and applications.

    PubMed

    Verde, Pablo E; Ohmann, Christian

    2015-03-01

    Researchers may have multiple motivations for combining disparate pieces of evidence in a meta-analysis, such as generalizing experimental results or increasing the power to detect an effect that a single study is not able to detect. However, while in meta-analysis, the main question may be simple, the structure of evidence available to answer it may be complex. As a consequence, combining disparate pieces of evidence becomes a challenge. In this review, we cover statistical methods that have been used for the evidence-synthesis of different study types with the same outcome and similar interventions. For the methodological review, a literature retrieval in the area of generalized evidence-synthesis was performed, and publications were identified, assessed, grouped and classified. Furthermore real applications of these methods in medicine were identified and described. For these approaches, 39 real clinical applications could be identified. A new classification of methods is provided, which takes into account: the inferential approach, the bias modeling, the hierarchical structure, and the use of graphical modeling. We conclude with a discussion of pros and cons of our approach and give some practical advice. PMID:26035469

  5. Behavioral approach with or without surgical intervention to the vulvar vestibulitis syndrome: a prospective randomized and non-randomized study.

    PubMed

    Weijmar Schultz, W C; Gianotten, W L; van der Meijden, W I; van de Wiel, H B; Blindeman, L; Chadha, S; Drogendijk, A C

    1996-09-01

    This article describes the outcome of a behavioral approach with or without preceding surgical intervention in 48 women with the vulvar vestibulitis syndrome. In the first part of the study, 14 women with the vulvar vestibulitis syndrome were randomly assigned to one of two treatment programs: either a behavioral approach or a behavioral approach preceded by surgery. In the second part of the study, 34 women and their partners were given a choice of treatment. Follow-up data were gathered a mean of 3 and 2 1/2 years after treatment, respectively. In the randomized patient population, the intervention had a positive effect on all of them: the complaints disappeared, diminished or did not change but formed less of a problem. The difference in outcome between the two different treatments, a behavioral approach with or without preceding surgery, was not statistically significant. In the second non-randomized part of the study, 28 out of the 34 women (82%) chose the behavioral approach without preceding surgery. The difference in outcome between the two treatments was not statistically significant. Two out of the 28 women who chose behavioral treatment without preceding surgery had to be referred for psychiatric consultation because of serious psycho-sexual problems. In one woman, psychiatric treatment was successful. Three other women, whose behavioral treatment failed, underwent additional surgery, which clearly helped them to overcome the deadlock in the behavioral approach. The behavioral approach should be the first choice of treatment for the vulvar vestibulitis syndrome. Surgical intervention should be considered as an additional form of treatment in some cases with the vulvar vestibulitis syndrome to facilitate breaking the vicious circle of irritation, pelvic floor muscle hypertonia and sexual maladaptive behavior.

  6. Short-term results after STARR versus internal Delorme for obstructed defecation: a non-randomized prospective study.

    PubMed

    Ohazuruike, N L; Martellucci, J; Menconi, C; Panicucci, S; Toniolo, G; Naldini, G

    2014-06-01

    Obstructed defecation syndrome due to internal intussusception and rectocele is a common disease, and various transanal surgical techniques have been proposed. Aim of the present study was to compare the internal Delorme (ID) and the stapled transanal rectal resection (STARR) results in the treatment of patients with obstructed defecation syndrome. From September 2011 to May 2012, 23 patients were operated with STARR procedure and 12 patients with Delorme's procedure for obstructed defecation syndrome. All patients underwent preoperative assessment: clinical evaluation (Altomare ODS score, Wexner constipation scoring system), proctoscopy, defecography, anorectal manometry and endoanal ultrasonography. Surgery was proposed with: failure of medical therapy, incomplete defecation, and unsuccessful attempts with long periods spent in bathroom, defecation with digital assistance, use of enemas and defecography findings of rectoanal intussusception and rectocele. The average operative time was 28 min (range 15-65) for the STARR group and 56 min (range 28-96) for the ID group with a mean hospital stay of 2 days for both the procedures. The Wexner score significantly fell postoperatively from 17 to 4, 7 in STARR group and from 15.3 to 3.3 in the ID group. The Altomare score postoperatively fell from 18.2 to 5.5 for STARR group and from 16.5 to 5.3 for ID group. No statistically significant differences were observed between the two procedures considering the outcomes parameters and the complications. Both ID and STARR procedure seem to be effective in the treatment of ODS.

  7. A non-randomized confirmatory study regarding selection of fertility-sparing surgery for patients with epithelial ovarian cancer: Japan Clinical Oncology Group Study (JCOG1203).

    PubMed

    Satoh, Toyomi; Tsuda, Hitoshi; Kanato, Keisuke; Nakamura, Kenichi; Shibata, Taro; Takano, Masashi; Baba, Tsukasa; Ishikawa, Mitsuya; Ushijima, Kimio; Yaegashi, Nobuo; Yoshikawa, Hiroyuki

    2015-06-01

    Fertility-sparing treatment has been accepted as a standard treatment for epithelial ovarian cancer in stage IA non-clear cell histology grade 1/grade 2. In order to expand an indication of fertility-sparing treatment, we have started a non-randomized confirmatory trial for stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The protocol-defined fertility-sparing surgery is optimal staging laparotomy including unilateral salpingo-oophorectomy, omentectomy, peritoneal cytology and pelvic and para-aortic lymph node dissection or biopsy. After fertility-sparing surgery, four to six cycles of adjuvant chemotherapy with paclitaxel and carboplatin are administered. We plan to enroll 250 patients with an indication of fertility-sparing surgery, and then the primary analysis is to be conducted for 63 operated patients with pathologically confirmed stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The primary endpoint is 5-year overall survival. Secondary endpoints are other survival endpoints and factors related to reproduction. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000013380. PMID:26059697

  8. A non-randomized confirmatory study regarding selection of fertility-sparing surgery for patients with epithelial ovarian cancer: Japan Clinical Oncology Group Study (JCOG1203).

    PubMed

    Satoh, Toyomi; Tsuda, Hitoshi; Kanato, Keisuke; Nakamura, Kenichi; Shibata, Taro; Takano, Masashi; Baba, Tsukasa; Ishikawa, Mitsuya; Ushijima, Kimio; Yaegashi, Nobuo; Yoshikawa, Hiroyuki

    2015-06-01

    Fertility-sparing treatment has been accepted as a standard treatment for epithelial ovarian cancer in stage IA non-clear cell histology grade 1/grade 2. In order to expand an indication of fertility-sparing treatment, we have started a non-randomized confirmatory trial for stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The protocol-defined fertility-sparing surgery is optimal staging laparotomy including unilateral salpingo-oophorectomy, omentectomy, peritoneal cytology and pelvic and para-aortic lymph node dissection or biopsy. After fertility-sparing surgery, four to six cycles of adjuvant chemotherapy with paclitaxel and carboplatin are administered. We plan to enroll 250 patients with an indication of fertility-sparing surgery, and then the primary analysis is to be conducted for 63 operated patients with pathologically confirmed stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The primary endpoint is 5-year overall survival. Secondary endpoints are other survival endpoints and factors related to reproduction. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000013380.

  9. Impact of Specialist Home-Based Palliative Care Services in a Tertiary Oncology Set Up: A Prospective Non-Randomized Observational Study

    PubMed Central

    Dhiliwal, Sunil R; Muckaden, Maryann

    2015-01-01

    Background: Home-based specialist palliative care services are developed to meet the needs of the patients in advanced stage of cancer at home with physical symptoms and distress. Specialist home care services are intended to improve symptom control and quality of life, enable patients to stay at home, and avoid unnecessary hospital admission. Materials and Methods: Total 690 new cases registered under home-based palliative care service in the year 2012 were prospectively studied to assess the impact of specialist home-based services using Edmonton symptom assessment scale (ESAS) and other parameters. Results: Out of the 690 registered cases, 506 patients received home-based palliative care. 50.98% patients were cared for at home, 28.85% patients needed hospice referral and 20.15% patients needed brief period of hospitalization. All patients receiving specialist home care had good relief of physical symptoms (P < 0.005). 83.2% patients received out of hours care (OOH) through liaising with local general practitioners; 42.68% received home based bereavement care and 91.66% had good bereavement outcomes. Conclusion: Specialist home-based palliative care improved symptom control, health-related communication and psychosocial support. It promoted increased number of home-based death, appropriate and early hospice referral, and averted needless hospitalization. It improved bereavement outcomes, and caregiver satisfaction. PMID:25709182

  10. Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study

    PubMed Central

    Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

    2015-01-01

    Background and Purpose Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. Methods We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. Results In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p<0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. Conclusions A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs’ abilities to apply EBP knowledge and skills when supervising students. PMID:25894559

  11. Evaluation of a tailored, multi-component intervention for implementation of evidence-based clinical practice guidelines in primary care physical therapy: a non-randomized controlled trial

    PubMed Central

    2014-01-01

    Background Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence-based practice (EBP). There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy. The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden. Methods An implementation strategy based on theory and current evidence was developed. A tailored, multi-component implementation intervention, addressing earlier identified determinants, was carried out in three areas comprising 28 physical therapy practices including 277 physical therapists (PTs) (intervention group). In two adjacent areas, 171 PTs at 32 practices received no intervention (control group). The core component of the intervention was an implementation seminar with group discussions. Among other components were a website and email reminders. Data were collected at baseline and follow-up with a web-based questionnaire. Primary outcomes were the self-reported awareness of, knowledge of, access to, and use of guidelines. Secondary outcomes were self-reported attitudes toward EBP and guidelines. Analyses were performed using Pearson’s χ2 test and approximative z-test. Results 168 PTs (60.6%) in the intervention group and 88 PTs (51.5%) in the control group responded to the follow-up questionnaire. 186/277 PTs (67.1%) participated in the implementation seminars, of which 97 (52.2%) responded. The proportions of PTs reporting awareness of (absolute difference in change 20.6%, p = 0.023), knowledge where to find (20.4%, p = 0.007), access to (21.7%, p < 0.001), and frequent use of (9.5%, NS) guidelines increased more in the intervention group than in the control group. The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2% (p = 0.043) higher than the

  12. Prospects of the clinical utilization of melatonin.

    PubMed

    Bubenik, G A; Blask, D E; Brown, G M; Maestroni, G J; Pang, S F; Reiter, R J; Viswanathan, M; Zisapel, N

    1998-01-01

    This review summarizes the present knowledge on melatonin in several areas on physiology and discusses various prospects of its clinical utilization. Ever increasing evidence indicates that melatonin has an immuno-hematopoietic role. In animal studies, melatonin provided protection against gram-negative septic shock, prevented stress-induced immunodepression, and restored immune function after a hemorrhagic shock. In human studies, melatonin amplified the antitumoral activity of interleukin-2. Melatonin has been proven as a powerful cytostatic drug in vitro as well as in vivo. In the human clinical field, melatonin appears to be a promising agent either as a diagnostic or prognostic marker of neoplastic diseases or as a compound used either alone or in combination with the standard cancer treatment. Utilization of melatonin for treatment of rhythm disorders, such as those manifested in jet lag, shift work or blindness, is one of the oldest and the most successful clinical application of this chemical. Low doses of melatonin applied in controlled-release preparation were very effective in improving the sleep latency, increasing the sleep efficiency and rising sleep quality scores in elderly, melatonin-deficient insomniacs. In the cardiovascular system, melatonin seems to regulate the tone of cerebral arteries; melatonin receptors in vascular beds appear to participate in the regulation of body temperature. Heat loss may be the principal mechanism in the initiation of sleepiness caused by melatonin. The role of melatonin in the development of migraine headaches is at present uncertain but more research could result in new ways of treatment. Melatonin is the major messenger of light-dependent periodicity, implicated in the seasonal reproduction of animals and pubertal development in humans. Multiple receptor sites detected in brain and gonadal tissues of birds and mammals of both sexes indicate that melatonin exerts a direct effect on the vertebrate reproductive

  13. In Heart Failure Patients with Left Bundle Branch Block Single Lead MultiSpot Left Ventricular Pacing Does Not Improve Acute Hemodynamic Response To Conventional Biventricular Pacing. A Multicenter Prospective, Interventional, Non-Randomized Study

    PubMed Central

    Sterliński, Maciej; Sokal, Adam; Lenarczyk, Radosław; Van Heuverswyn, Frederic; Rinaldi, C. Aldo; Vanderheyden, Marc; Khalameizer, Vladimir; Francis, Darrel; Heynens, Joeri; Stegemann, Berthold; Cornelussen, Richard

    2016-01-01

    Introduction Recent efforts to increase CRT response by multiSPOT pacing (MSP) from multiple bipols on the same left ventricular lead are still inconclusive. Aim The Left Ventricular (LV) MultiSPOTpacing for CRT (iSPOT) study compared the acute hemodynamic response of MSP pacing by using 3 electrodes on a quadripolar lead compared with conventional biventricular pacing (BiV). Methods Patients with left bundle branch block (LBBB) underwent an acute hemodynamic study to determine the %change in LV+dP/dtmax from baseline atrial pacing compared to the following configurations: BiV pacing with the LV lead in a one of lateral veins, while pacing from the distal, mid, or proximal electrode and all 3 electrodes together (i.e. MSP). All measurements were repeated 4 times at 5 different atrioventricular delays. We also measured QRS-width and individual Q-LV durations. Results Protocol was completed in 24 patients, all with LBBB (QRS width 171±20 ms) and 58% ischemic aetiology. The percentage change in LV+dP/dtmax for MSP pacing was 31.0±3.3% (Mean±SE), which was not significantly superior to any BiV pacing configuration: 28.9±3.2% (LV-distal), 28.3±2.7% (LV-mid), and 29.5±3.0% (LV-prox), respectively. Correlation between LV+dP/dtmax and either QRS-width or Q-LV ratio was poor. Conclusions In patients with LBBB MultiSPOT LV pacing demonstrated comparable improvement in contractility to best conventional BiV pacing. Optimization of atrioventricular delay is important for the best performance for both BiV and MultiSPOT pacing configurations. Trial Registration ClinicalTrials.gov NTC01883141 PMID:27124724

  14. Non-random patterns in viral diversity

    PubMed Central

    Anthony, Simon J.; Islam, Ariful; Johnson, Christine; Navarrete-Macias, Isamara; Liang, Eliza; Jain, Komal; Hitchens, Peta L.; Che, Xiaoyu; Soloyvov, Alexander; Hicks, Allison L.; Ojeda-Flores, Rafael; Zambrana-Torrelio, Carlos; Ulrich, Werner; Rostal, Melinda K.; Petrosov, Alexandra; Garcia, Joel; Haider, Najmul; Wolfe, Nathan; Goldstein, Tracey; Morse, Stephen S.; Rahman, Mahmudur; Epstein, Jonathan H.; Mazet, Jonna K.; Daszak, Peter; Lipkin, W. Ian

    2015-01-01

    It is currently unclear whether changes in viral communities will ever be predictable. Here we investigate whether viral communities in wildlife are inherently structured (inferring predictability) by looking at whether communities are assembled through deterministic (often predictable) or stochastic (not predictable) processes. We sample macaque faeces across nine sites in Bangladesh and use consensus PCR and sequencing to discover 184 viruses from 14 viral families. We then use network modelling and statistical null-hypothesis testing to show the presence of non-random deterministic patterns at different scales, between sites and within individuals. We show that the effects of determinism are not absolute however, as stochastic patterns are also observed. In showing that determinism is an important process in viral community assembly we conclude that it should be possible to forecast changes to some portion of a viral community, however there will always be some portion for which prediction will be unlikely. PMID:26391192

  15. [Clinical nursing manpower: development and future prospects].

    PubMed

    Lin, Chiou-Fen; Kao, Ching-Chiu

    2014-04-01

    The significant changes in nursing manpower utilization in Taiwan over the past two decades are due in large part to the implementation of the National Health Insurance program and the rising need for long-term care. The changes have impacted clinical nursing manpower utilization in two important ways. Firstly, there has been a substantial increase in overall demand for nursing manpower. In particular, the need for clinical nurses has nearly quadrupled during this time period. Secondly, the level of difficulty involved in patient care has risen dramatically, with factors including increased disease severity and increased care quality expectations, among others. These changes, coupled with demands on nursing manpower imposed from other sectors, underpin and further exacerbate the problem of nursing manpower shortages throughout the healthcare system. To raise the quality of the nursing work environment, the Ministry of Health and Welfare (MOHW) brought together Taiwan's key professional nursing organizations to promote 10 care-reform strategies, establish the nursing-aid manpower system, and create the nursing classification system as an approach to effectively attract nurses to take positions in the medical system.

  16. Prospective Clinical Study of Precision Oncology in Solid Tumors.

    PubMed

    Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

    2015-11-09

    Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy.

  17. Prospects of Nanotechnology in Clinical Immunodiagnostics

    PubMed Central

    Ansari, Anees A.; Alhoshan, Mansour; Alsalhi, Mohamad S.; Aldwayyan, Abdullah S.

    2010-01-01

    Nanostructured materials are promising compounds that offer new opportunities as sensing platforms for the detection of biomolecules. Having micrometer-scale length and nanometer-scale diameters, nanomaterials can be manipulated with current nanofabrication methods, as well as self-assembly techniques, to fabricate nanoscale bio-sensing devices. Nanostructured materials possess extraordinary physical, mechanical, electrical, thermal and multifunctional properties. Such unique properties advocate their use as biomimetic membranes to immobilize and modify biomolecules on the surface of nanoparticles. Alignment, uniform dispersion, selective growth and diameter control are general parameters which play critical roles in the successful integration of nanostructures for the fabrication of bioelectronic sensing devices. In this review, we focus on different types and aspects of nanomaterials, including their synthesis, properties, conjugation with biomolecules and their application in the construction of immunosensing devices. Some key results from each cited article are summarized by relating the concept and mechanism behind each sensor, experimental conditions and the behavior of the sensor under different conditions, etc. The variety of nanomaterial-based bioelectronic devices exhibiting novel functions proves the unique properties of nanomaterials in such sensing devices, which will surely continue to expand in the future. Such nanomaterial based devices are expected to have a major impact in clinical immunodiagnostics, environmental monitoring, security surveillance and for ensuring food safety. PMID:22163566

  18. Doppler bubble detection and decompression sickness: a prospective clinical trial.

    PubMed

    Bayne, C G; Hunt, W S; Johanson, D C; Flynn, E T; Weathersby, P K

    1985-09-01

    Decompression sickness in human beings exposed to high ambient pressure is thought to follow from gas bubble formation and growth in the body during return to low pressure. Detection of Doppler-shifted ultrasonic reflections in major blood vessels has been promoted as a noninvasive and sensitive indicator of the imminence of decompression sickness. We have conducted a double-blind, prospective clinical trial of Doppler ultrasonic bubble detection in simulated diving using 83 men, of whom 8 were stricken and treated for the clinical disease. Diagnosis based only on the Doppler signals had no correlation with clinical diagnosis. Bubble scores were only slightly higher in the stricken group. The Doppler technique does not appear to be of diagnostic value in the absence of other clinical information.

  19. The quality of control groups in non-randomized studies published in Journal of Hand Surgery

    PubMed Central

    Johnson, Shepard P.; Malay, Sunitha; Chung, Kevin C.

    2016-01-01

    Purpose To evaluate control group selection in non-randomized studies published in the Journal of Hand Surgery American (JHS). Methods We reviewed all papers published in JHS in 2013 to identify studies that used non-randomized control groups. Data collected included type of study design and control group characteristics. We then appraised studies to determine if authors discussed confounding and selection bias and how they controlled for confounding. Results Thirty-seven non-randomized studies were published in JHS in 2013. The source of control was either the same institution as the study group, a different institution, a database, or not provided in the manuscript. Twenty-nine (78%) studies statistically compared key characteristics between control and study group. Confounding was controlled with matching, exclusion criteria, or regression analysis. Twenty-two (59%) papers explicitly discussed the threat of confounding and 18(49%) identified sources of selection bias. Conclusions In our review of non-randomized studies published in JHS, papers had well-defined controls that were similar to the study group, allowing for reasonable comparisons. However, we identified substantial confounding and bias that were not addressed as explicit limitations, which might lead the reader to overestimate the scientific validity of the data. Clinical relevance Incorporating a brief discussion of control group selection in scientific manuscripts should help readers interpret the study more appropriately. Authors, reviewers, and editors should strive to address this component of clinical importance. PMID:25447000

  20. The Influence of Plantar Short Foot Muscle Exercises on Foot Posture and Fundamental Movement Patterns in Long-Distance Runners, a Non-Randomized, Non-Blinded Clinical Trial

    PubMed Central

    Sulowska, Iwona; Oleksy, Łukasz; Mika, Anna; Bylina, Dorota; Sołtan, Jarosław

    2016-01-01

    Background The objective of this study was to evaluate the influence of two kinds of plantar short foot muscles exercise on foot posture and fundamental movement patterns in long-distance runners. Design A parallel group non-blinded trial with 6-week follow-up. Methods Twenty five long-distance runners aged 22–35 years. They were divided into two groups. In group 1 (n = 13) subjects performed the exercise “Vele’s Forward Lean” and “Reverse Tandem Gait” and in Group 2 (n = 12) the “Short Foot Exercise.” The runners performed the exercises daily for 6 weeks. The Foot Posture Index (FPI-6) and The Functional Movement Screen (FMS) tests were performed twice: at baseline and after 6 weeks of the exercise. Results A significant improvement was observed in FPI -6 (talar head palpation in Group 1, and inversion/eversion of the calcaneus in Group 2). Also in Group 1 a significant improvement was noted in FMS tests: deep squat, active straight leg raise and in total score. Conclusions Short foot muscles strengthening exercises have beneficial effect on functional movement patterns and on foot posture, therefore they should be included as a part of daily training program of runners. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12615001200572 PMID:27336689

  1. Ocular lateropulsion in Wallenberg's syndrome: a prospective clinical study.

    PubMed

    Crevits, L; vander Eecken, H

    1982-03-01

    In order to evaluate the occurrence and clinical value of ocular lateropulsion in Wallenberg's syndrome, a prospective study was carried out. Lateropulsion of the horizontal and vertical refixation saccades was a rather regular finding, especially in complete Wallenberg's syndrome. Lateral ocular deviation after elimination of fixation was present in nearly all cases. The tonic lateral vector was always directed to the involved side. It is concluded that ocular lateropulsion is an easily elicited sign with a lateralizing value in lateral bulbar infarction. Further systematic search of ocular lateropulsion in other posterior fossa disorders is needed to determine its topographical significance.

  2. Building sustainable multi-functional prospective electronic clinical data systems.

    PubMed

    Randhawa, Gurvaneet S; Slutsky, Jean R

    2012-07-01

    A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders.

  3. Bacterial keratitis: a prospective clinical and microbiological study

    PubMed Central

    Schaefer, F.; Bruttin, O.; Zografos, L.; Guex-Crosier, Y.

    2001-01-01

    AIM—To define the clinical and microbiological profile of bacterial keratitis at the Jules Gonin Eye Hospital and to test the in vitro bacterial resistance.
METHODS—Patients presenting with bacterial keratitis were prospectively followed; clinical features (age, risk factors, visual acuity) and response to therapy were analysed. Bacteriological profile was determined and the sensitivity/resistance of isolated strains were tested towards 12 ocular antibiotics (NCCLS disc diffusion test).
RESULTS—85 consecutive patients (mean age 44.3 (SD 20.7) years) were prospectively enrolled from 1 March 1997 to 30 November 1998. The following risk factors were identified: contact lens wear, 36%; blepharitis, 21%; trauma, 20%; xerophthalmia, 15%; keratopathies, 8%; and eyelid abnormalities, 6%. The most commonly isolated bacteria were Staphylococcus epidermidis, 40%; Staphylococcus aureus, 22%; Streptococcus pneumoniae, 8%; others Streptococcus species, 5%; Pseudomonas, 9%; Moraxella and Serratia marcescens, 5% each; Bacillus, Corynebacterium, Alcaligenes xyloxidans, Morganella morganii, and Haemophilus influenza, 1% each. 1-15% of strains were resistant to fluoroquinolones, 13-22% to aminoglycosides, 37% to cefazolin, 18% to chloramphenicol, 54% to polymyxin B, 51% to fusidic acid, and 45% to bacitracin. Five of the 85 patients (5.8%) had a poor clinical outcome with a visual loss of one or more lines of visual acuity.
CONCLUSION—Fluoroquinolones appear to be the therapy of choice for bacterial keratitis, but, based upon these in vitro studies, some strains may be resistant.

 PMID:11423460

  4. A prospective clinical study of polycarboxylate cement in periapical surgery

    PubMed Central

    Ortega-Sánchez, Bárbara; García-Mira, Berta; Maestre-Ferrín, Laura; Peñarrocha-Oltra, David; Gay-Escoda, Cosme

    2012-01-01

    Objective: To evaluate the clinical efficacy of polycarboxylate cement as retrograde filling material. Design: A prospective clinical study was made of 25 patients subjected to periapical surgery with ultrasound and magnifying loupes, in which polycarboxylate cement was used as retrograde filling material. Measurements were made of the area and diameter of the lesions pre- and postoperatively, and 6 and 12 months after the operation. The apical resection and retrograde filling areas were also measured, and the prognosis following surgery was recorded. Results: A total of 23 patients with 31 apicoectomized teeth were studied (2 patients being lost to follow-up). The mean area of the periapical lesions before surgery was 52.25 mm2, with a mean major diameter of 6.1 mm and a mean lesser diameter of 4.8 mm. The success rate after 12 months was 54.7%, according to the criteria of Von Arx and Kurt. The prognosis was poorer in females, in larger lesions, and in cases with larger retrograde filling areas. Conclusions: Polycarboxylate cement offers good results, with important bone regeneration after periapical surgery. Key words: Periapical surgery, endodontic treatment, polycarboxylate cement. PMID:22143701

  5. Prospective Clinical Testing of Regulatory Dendritic Cells in Organ Transplantation

    PubMed Central

    Thomson, Angus W.; Zahorchak, Alan F.; Ezzelarab, Mohamed B.; Butterfield, Lisa H.; Lakkis, Fadi G.; Metes, Diana M.

    2016-01-01

    Dendritic cells (DC) are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg) with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering the incidence and severity of rejection and reducing patients’ dependence on anti-rejection drugs. Generation of donor- or recipient-derived DCreg that suppress T cell responses and prolong transplant survival in rodents or non-human primates has been well-described. Recently, good manufacturing practice (GMP)-grade DCreg have been produced at our Institution for prospective use in human organ transplantation. We briefly review experience of regulatory immune therapy in organ transplantation and describe our experience generating and characterizing human monocyte-derived DCreg. We propose a phase I/II safety study in which the influence of donor-derived DCreg combined with conventional immunosuppression on subclinical and clinical rejection and host alloimmune responses will be examined in detail. PMID:26858719

  6. Percutaneous cryodenervation of lumbar facet joints: a prospective clinical trial

    PubMed Central

    Veihelmann, A.; Trouillier, H.; Hausdorf, J.; Devens, C.; Wegener, B.; Jansson, V.; von Schulze Pellengahr, C.

    2006-01-01

    Facet joint pain is an important aspect of degenerative lumbar spine disease, and radiofrequency medial branch neurotomy remains an established therapy, while cryodenervation has still been poorly examined. This study was undertaken to examine the effects of medial branch cryodenervation in the treatment of lumbar facet joint pain. This was a prospective clinical case series. Patient selection was based on the history, physical examination and positive medial branch blocks. Percutaneous medial branch cryodenervation was performed using a Lloyd Neurostat 2000. Target parameters were low back pain (VAS), limitation of activity (McNab) and overall satisfaction. Fifty patients were recruited, and 46 completed the study. The follow-up time was 1 year. At 6 weeks, 33 patients (72%) were pain free or had major improvement of low back pain; 13 (28%) had no or little improvement. Including failures, mean low back pain decreased significantly from 7.7 preoperatively to 3.2 at 6 weeks, 3.3 at 3 months, 3.0 at 6 months and 4.2 at 12 months (P<0.0001). Limitation of the activities of daily living improved parallel to reduced pain. Our results suggest that medial branch cryodenervation is a safe and effective treatment for lumbar facet joint pain. PMID:16927087

  7. Prospective randomized clinical trial: single and weekly viscosupplementation

    PubMed Central

    Zóboli, Alejandro Agustin Carri; de Rezende, Márcia Uchôa; de Campos, Gustavo Constantino; Pasqualin, Thiago; Frucchi, Renato; de Camargo, Olavo Pires

    2013-01-01

    OBJECTIVE: To compare two different dosages of an intermediate molecular weight sodium hyaluronate (HA) (Osteonil®-TRB Pharma) assessing whether a single 6 ml application of this HA has the same effectiveness as the classical three-weekly 2 ml dose. METHODS: 108 patients with knee osteoarthritis were randomized into two groups of 54 patients each. The groups were designated "single" (S) and "weekly" (W). Patients in group S underwent a viscosupplementation procedure by application of only 6 ml of sodium hyaluronate and 1 ml triamcinolone hexacetonide. Patients in group W underwent the procedure of viscosupplementation through three applications with 2 ml sodium hyaluronate with a week interval between them, and the first application was also performed with the infiltration of 1 ml (20 mg) of Triamcinolone Hexacetonide. Both groups were assessed before, at one month and three months after application, by responding to the WOMAC, Lequesne, IKDC and VAS questionnaires. RESULTS: There was no statistical difference between the single application of 6 ml of sodium hyaluronate and classic application with three weekly injections. However, only the classical regime showed statistically significant improvement in baseline pain (WOMAC pain and VAS). CONCLUSION: Our results suggest that both application schemes improve application function, but the three-weekly regimen of 2 ml was more effective in reducing pain. Level of Evidence I, Prospective Randomized, Clinical Trial. PMID:24453681

  8. Idiopathic intracranial hypertension: ongoing clinical challenges and future prospects

    PubMed Central

    Julayanont, Parunyou; Karukote, Amputch; Ruthirago, Doungporn; Panikkath, Deepa; Panikkath, Ragesh

    2016-01-01

    Idiopathic intracranial hypertension (IIH) is an uncommon disorder characterized by increased intracranial pressure without radiological or laboratory evidence of intracranial pathology except empty sella turcica, optic nerve sheath with filled out cerebrospinal fluid spaces, and smooth-walled nonflow-related venous sinus stenosis or collapse. This condition typically affects obese women. The incidence of IIH is increasing with the rising prevalence of obesity. Persistent headache is the most common symptom. Visual impairment is a serious complication that may not be recognized by the patients. This paper reviews clinical manifestations, diagnostic challenges, and current treatments of IIH in adults. Various imaging modalities have been studied on their validity for detection of IIH and papilledema. This review also includes new studies on medical, surgical, and interventional management of this condition. Acetazolamide and topiramate are the only two medications that have been studied in randomized controlled trials about their efficacy in treatment of IIH. In patients who have severe visual impairment or progressive visual deterioration despite medical management, surgical or interventional treatment may be considered. The efficacy and complications of cerebrospinal fluid diversion, optic nerve sheath fenestration, and endovascular venous stenting reported in the last 3 decades have been summarized in this review. Finally, the prospective aspects of biomarkers and treatments are proposed for future research. PMID:26929666

  9. A prospective clinical study of patients with hypernatraemic dehydration.

    PubMed

    Eke, F; Nte, A

    1996-09-01

    In a clinical prospective 3-year study of 158 children aged 2 weeks to 14 years with hypernatraemic dehydration (serum sodium 150 mmol/l or more), infants predominated (61.4%). The 158 children with hypernatraemia accounted for 13.7% of all children admitted with gastroenteritis over the same period, and significant aetiological factors included the use of artificial feeds, differences between the children with hypernatraemia and those with normo- or hyponatraemia, P < 0.001, P < 0.001, respectively; the use of breast milk, P < 0.001, P < 0.001, respectively; nutritional status, P < 0.001, P < 0.001, respectively; and clinical state of mild to moderate dehydration P < 0.001; P < 0.001, respectively; but not with patients considered severely dehydrated. There was also a significant difference between the presence of neurological features in hyper- and normonatraemic patients P < 0.001; in hyper- and hyponatraemic patients P < 0.05, and in mortality rate between hyper- and normonatraemic patients, P < 0.05 but not between hyper- and hyponatraemic patients. A history of refusal to feed or vomiting was obtained in 41 children (25.9%). The mean serum sodium was 155.5 mmol/l (range 150-189 mmol/l); mean serum urea 7.7 mmol/l (range 1-18.9 mmol/l). Hypernatraemic dehydration remains an important and serious complication of childhood gastroenteritis in our area of study. The use of artificial milk feeds is contributory, and well-nourished babies appear more at risk. We recommend more liberal water intake during gastroenteritis and the public should also be educated on and made more aware of this condition.

  10. Toward Fully Automated Multicriterial Plan Generation: A Prospective Clinical Study

    SciTech Connect

    Voet, Peter W.J.; Dirkx, Maarten L.P.; Breedveld, Sebastiaan; Fransen, Dennie; Levendag, Peter C.; Heijmen, Ben J.M.

    2013-03-01

    Purpose: To prospectively compare plans generated with iCycle, an in-house-developed algorithm for fully automated multicriterial intensity modulated radiation therapy (IMRT) beam profile and beam orientation optimization, with plans manually generated by dosimetrists using the clinical treatment planning system. Methods and Materials: For 20 randomly selected head-and-neck cancer patients with various tumor locations (of whom 13 received sequential boost treatments), we offered the treating physician the choice between an automatically generated iCycle plan and a manually optimized plan using standard clinical procedures. Although iCycle used a fixed “wish list” with hard constraints and prioritized objectives, the dosimetrists manually selected the beam configuration and fine tuned the constraints and objectives for each IMRT plan. Dosimetrists were not informed in advance whether a competing iCycle plan was made. The 2 plans were simultaneously presented to the physician, who then selected the plan to be used for treatment. For the patient group, differences in planning target volume coverage and sparing of critical tissues were quantified. Results: In 32 of 33 plan comparisons, the physician selected the iCycle plan for treatment. This highly consistent preference for the automatically generated plans was mainly caused by the improved sparing for the large majority of critical structures. With iCycle, the normal tissue complication probabilities for the parotid and submandibular glands were reduced by 2.4% ± 4.9% (maximum, 18.5%, P=.001) and 6.5% ± 8.3% (maximum, 27%, P=.005), respectively. The reduction in the mean oral cavity dose was 2.8 ± 2.8 Gy (maximum, 8.1 Gy, P=.005). For the swallowing muscles, the esophagus and larynx, the mean dose reduction was 3.3 ± 1.1 Gy (maximum, 9.2 Gy, P<.001). For 15 of the 20 patients, target coverage was also improved. Conclusions: In 97% of cases, automatically generated plans were selected for treatment because of

  11. 75 FR 54889 - Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... tretinoins, beta blockers (especially those entering the brain), reserpine, drugs for smoking cessation, and... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials; Availability AGENCY: Food and Drug Administration, HHS....

  12. Interval process model and non-random vibration analysis

    NASA Astrophysics Data System (ADS)

    Jiang, C.; Ni, B. Y.; Liu, N. Y.; Han, X.; Liu, J.

    2016-07-01

    This paper develops an interval process model for time-varying or dynamic uncertainty analysis when information of the uncertain parameter is inadequate. By using the interval process model to describe a time-varying uncertain parameter, only its upper and lower bounds are required at each time point rather than its precise probability distribution, which is quite different from the traditional stochastic process model. A correlation function is defined for quantification of correlation between the uncertain-but-bounded variables at different times, and a matrix-decomposition-based method is presented to transform the original dependent interval process into an independent one for convenience of subsequent uncertainty analysis. More importantly, based on the interval process model, a non-random vibration analysis method is proposed for response computation of structures subjected to time-varying uncertain external excitations or loads. The structural dynamic responses thus can be derived in the form of upper and lower bounds, providing an important guidance for practical safety analysis and reliability design of structures. Finally, two numerical examples and one engineering application are investigated to demonstrate the feasibility of the interval process model and corresponding non-random vibration analysis method.

  13. 42 CFR 421.505 - Termination and extension of non-random prepayment complex medical review.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... error are no longer suspended for non-random prepayment complex medical review. (d) Periodic re... that appears to have resumed a high level of payment error on non-random prepayment complex medical... 42 Public Health 3 2011-10-01 2011-10-01 false Termination and extension of non-random...

  14. Development in Children with Achondroplasia: A Prospective Clinical Cohort Study

    ERIC Educational Resources Information Center

    Ireland, Penelope J.; Donaghey, Samantha; McGill, James; Zankl, Andreas; Ware, Robert S.; Pacey, Verity; Ault, Jenny; Savarirayan, Ravi; Sillence, David; Thompson, Elizabeth; Townshend, Sharron; Johnston, Leanne M.

    2012-01-01

    Aim: Achondroplasia is characterized by delays in the development of communication and motor skills. While previously reported developmental profiles exist across gross motor, fine motor, feeding, and communication skills, there has been no prospective study of development across multiple areas simultaneously. Method: This Australasian…

  15. Non-random DNA fragmentation in next-generation sequencing

    NASA Astrophysics Data System (ADS)

    Poptsova, Maria S.; Il'Icheva, Irina A.; Nechipurenko, Dmitry Yu.; Panchenko, Larisa A.; Khodikov, Mingian V.; Oparina, Nina Y.; Polozov, Robert V.; Nechipurenko, Yury D.; Grokhovsky, Sergei L.

    2014-03-01

    Next Generation Sequencing (NGS) technology is based on cutting DNA into small fragments, and their massive parallel sequencing. The multiple overlapping segments termed ``reads'' are assembled into a contiguous sequence. To reduce sequencing errors, every genome region should be sequenced several dozen times. This sequencing approach is based on the assumption that genomic DNA breaks are random and sequence-independent. However, previously we showed that for the sonicated restriction DNA fragments the rates of double-stranded breaks depend on the nucleotide sequence. In this work we analyzed genomic reads from NGS data and discovered that fragmentation methods based on the action of the hydrodynamic forces on DNA, produce similar bias. Consideration of this non-random DNA fragmentation may allow one to unravel what factors and to what extent influence the non-uniform coverage of various genomic regions.

  16. Non-random DNA fragmentation in next-generation sequencing

    PubMed Central

    Poptsova, Maria S.; Il'icheva, Irina A.; Nechipurenko, Dmitry Yu.; Panchenko, Larisa A.; Khodikov, Mingian V.; Oparina, Nina Y.; Polozov, Robert V.; Nechipurenko, Yury D.; Grokhovsky, Sergei L.

    2014-01-01

    Next Generation Sequencing (NGS) technology is based on cutting DNA into small fragments, and their massive parallel sequencing. The multiple overlapping segments termed “reads” are assembled into a contiguous sequence. To reduce sequencing errors, every genome region should be sequenced several dozen times. This sequencing approach is based on the assumption that genomic DNA breaks are random and sequence-independent. However, previously we showed that for the sonicated restriction DNA fragments the rates of double-stranded breaks depend on the nucleotide sequence. In this work we analyzed genomic reads from NGS data and discovered that fragmentation methods based on the action of the hydrodynamic forces on DNA, produce similar bias. Consideration of this non-random DNA fragmentation may allow one to unravel what factors and to what extent influence the non-uniform coverage of various genomic regions. PMID:24681819

  17. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

  18. Clinical Evaluation of Predictive Data for Prospective Home Economics Teachers.

    ERIC Educational Resources Information Center

    Gilbert, Ardyce Lucile

    This investigation, part of a longitudinal study of homemaking teacher effectiveness, was designed to explore the usefulness of clinical judgments to predict teacher success. Clinical judgment is defined as involving the ability to make sound decisions after gathering and evaluating all the pertinent evidence, weighing possible alternatives in…

  19. Current Status and Future Prospects of Clinical Psycholog

    PubMed Central

    Baker, Timothy B.; McFall, Richard M.; Shoham, Varda

    2010-01-01

    SUMMARY The escalating costs of health care and other recent trends have made health care decisions of great societal import, with decision-making responsibility often being transferred from practitioners to health economists, health plans, and insurers. Health care decision making increasingly is guided by evidence that a treatment is efficacious, effective–disseminable, cost-effective, and scientifically plausible. Under these conditions of heightened cost concerns and institutional–economic decision making, psychologists are losing the opportunity to play a leadership role in mental and behavioral health care: Other types of practitioners are providing an increasing proportion of delivered treatment, and the use of psychiatric medication has increased dramatically relative to the provision of psychological interventions. Research has shown that numerous psychological interventions are efficacious, effective, and cost-effective. However, these interventions are used infrequently with patients who would benefit from them, in part because clinical psychologists have not made a convincing case for the use of these interventions (e.g., by supplying the data that decision makers need to support implementation of such interventions) and because clinical psychologists do not themselves use these interventions even when given the opportunity to do so. Clinical psychologists’ failure to achieve a more significant impact on clinical and public health may be traced to their deep ambivalence about the role of science and their lack of adequate science training, which leads them to value personal clinical experience over research evidence, use assessment practices that have dubious psychometric support, and not use the interventions for which there is the strongest evidence of efficacy. Clinical psychology resembles medicine at a point in its history when practitioners were operating in a largely prescientific manner. Prior to the scientific reform of medicine in the

  20. Current Status and Future Prospects of Clinical Psycholog

    PubMed Central

    Baker, Timothy B.; McFall, Richard M.; Shoham, Varda

    2010-01-01

    SUMMARY The escalating costs of health care and other recent trends have made health care decisions of great societal import, with decision-making responsibility often being transferred from practitioners to health economists, health plans, and insurers. Health care decision making increasingly is guided by evidence that a treatment is efficacious, effective–disseminable, cost-effective, and scientifically plausible. Under these conditions of heightened cost concerns and institutional–economic decision making, psychologists are losing the opportunity to play a leadership role in mental and behavioral health care: Other types of practitioners are providing an increasing proportion of delivered treatment, and the use of psychiatric medication has increased dramatically relative to the provision of psychological interventions. Research has shown that numerous psychological interventions are efficacious, effective, and cost-effective. However, these interventions are used infrequently with patients who would benefit from them, in part because clinical psychologists have not made a convincing case for the use of these interventions (e.g., by supplying the data that decision makers need to support implementation of such interventions) and because clinical psychologists do not themselves use these interventions even when given the opportunity to do so. Clinical psychologists’ failure to achieve a more significant impact on clinical and public health may be traced to their deep ambivalence about the role of science and their lack of adequate science training, which leads them to value personal clinical experience over research evidence, use assessment practices that have dubious psychometric support, and not use the interventions for which there is the strongest evidence of efficacy. Clinical psychology resembles medicine at a point in its history when practitioners were operating in a largely prescientific manner. Prior to the scientific reform of medicine in the

  1. Accuracy of clinical diagnosis in parkinsonism--a prospective study.

    PubMed

    Rajput, A H; Rozdilsky, B; Rajput, A

    1991-08-01

    Clinical diagnosis of Parkinson's syndrome (PS) is reasonably easy in most cases but the distinction between different variants of PS may be difficult in early cases. The correct diagnosis is not only important for counselling and management of patients but also in conducting pharmacological and epidemiological studies. There is very little critical literature on the pathological verification of the clinical diagnosis in PS. We report our 22 years experience to address that issue. Between 1968 and 1990, 65 PS patients came to autopsy. Complete data are available in 59 (M-50, F-19) cases. The initial diagnosis made by a qualified neurologist was idiopathic Parkinson's disease (IPD) in 43 cases. Of those 28 (65%) had Lewy body pathology. After a mean duration of 12 years the final diagnosis was IPD in 41 cases which was confirmed in 31 (76%). The IPD could not be clinically distinguished from cases with severe substantia nigra neuronal loss without inclusions or from those with neurofibrillary tangle inclusions and neuronal loss at the anatomical sites typically involved in IPD. All progressive supra-nuclear palsy, olivopontocerebellar atrophy, Jakob-Creutzfeldt's disease and the majority of the multiple system atrophy cases were diagnosed correctly during life. The correct clinical diagnosis in most non-IPD variants of PS was possible within 5 years of onset (range: 2 months to 18 years). We recommend that studies aimed at including only the IPD cases restrict the enrollment to those cases that have had PS motor manifestations for five years or longer duration. PMID:1913360

  2. Heart Xenotransplantation: Historical Background, Experimental Progress, and Clinical Prospects.

    PubMed

    Murthy, Raghav; Bajona, Pietro; Bhama, Jay K; Cooper, David K C

    2016-04-01

    If pig hearts could be transplanted successfully into patients with end-stage cardiac failure, the critical shortage of hearts from deceased human donors would be overcome. The several attempts at cardiac xenotransplantation carried out in the 20th century, usually with hearts from nonhuman primates (NHPs), are reviewed, as are the surgical techniques used in experimental heart transplantation in animals. For a number of reasons, the pig has been selected as the potential source of organs for clinical transplantation. The major pathobiological barriers that the pig presents, and progress in overcoming these barriers either by genetic engineering of the pig or by the administration of novel immunosuppressive agents, are described. Currently, non-life-supporting pig heterotopic heart transplantation in NHPs has extended to more than 2 years in 1 case, with life-supporting orthotopic heart transplantation of almost 2 months. Future approaches to resolve the remaining problems and the selection of patients for the initial clinical trials are briefly discussed.

  3. Reducing bias in survival under non-random temporary emigration

    USGS Publications Warehouse

    Peñaloza, Claudia L.; Kendall, William L.; Langtimm, Catherine Ann

    2014-01-01

    Despite intensive monitoring, temporary emigration from the sampling area can induce bias severe enough for managers to discard life-history parameter estimates toward the terminus of the times series (terminal bias). Under random temporary emigration unbiased parameters can be estimated with CJS models. However, unmodeled Markovian temporary emigration causes bias in parameter estimates and an unobservable state is required to model this type of emigration. The robust design is most flexible when modeling temporary emigration, and partial solutions to mitigate bias have been identified, nonetheless there are conditions were terminal bias prevails. Long-lived species with high adult survival and highly variable non-random temporary emigration present terminal bias in survival estimates, despite being modeled with the robust design and suggested constraints. Because this bias is due to uncertainty about the fate of individuals that are undetected toward the end of the time series, solutions should involve using additional information on survival status or location of these individuals at that time. Using simulation, we evaluated the performance of models that jointly analyze robust design data and an additional source of ancillary data (predictive covariate on temporary emigration, telemetry, dead recovery, or auxiliary resightings) in reducing terminal bias in survival estimates. The auxiliary resighting and predictive covariate models reduced terminal bias the most. Additional telemetry data was effective at reducing terminal bias only when individuals were tracked for a minimum of two years. High adult survival of long-lived species made the joint model with recovery data ineffective at reducing terminal bias because of small-sample bias. The naïve constraint model (last and penultimate temporary emigration parameters made equal), was the least efficient, though still able to reduce terminal bias when compared to an unconstrained model. Joint analysis of several

  4. The human genome project: Prospects and implications for clinical medicine

    SciTech Connect

    Green, E.D.; Waterston, R.H. )

    1991-10-09

    The recently initiated human genome project is a large international effort to elucidate the genetic architecture of the genomes of man and several model organisms. The initial phases of this endeavor involve the establishment of rough blueprints (maps) of the genetic landscape of these genomes, with the long-term goal of determining their precise nucleotide sequences and identifying the genes. The knowledge gained by these studies will provide a vital tool for the study of many biologic processes and will have a profound impact on clinical medicine.

  5. Current Status of Xenotransplantation and Prospects for Clinical Application

    PubMed Central

    Pierson, Richard N.; Dorling, Anthony; Ayares, David; Rees, Michael A.; Seebach, Jörg D.; Fishman, Jay A.; Hering, Bernhard J.; Cooper, David K.C.

    2010-01-01

    Xenotransplantation is one promising approach to bridge the gap between available human cells, tissues, and organs and the needs of patients with diabetes or end-stage organ failure. Based on recent progress using genetically-modified source pigs, improving results with conventional and experimental immunosuppression, and expanded understanding of residual physiologic hurdles, xenotransplantation appears likely to be evaluated in clinical trials in the near future for some select applications. This review offers a comprehensive overview of known mechanisms of xenograft injury, a contemporary assessment of preclinical progress and residual barriers, and our opinions regarding where breakthroughs are likely to occur. PMID:19796067

  6. A Comprehensive Prospective Clinical Study of Hydatid Disease

    PubMed Central

    Kayal, Ankit; Hussain, Akhlak

    2014-01-01

    The actual prevalence of hydatid disease in northern part of India is found more than usually interpreted. The present study has been done on 25 patients suffering from hydatid disease of various sites and treated during June 2009 to November 2011 at JLN Medical College and Hospital, Ajmer, with the aim of studying the clinical manifestations of hydatid disease of different sites and/or organ system and of analysing the morbidity and mortality of hydatid disease. The age, sex, h/o dog contact, duration of hospital stay, clinical presentation, treatment advised, findings and difficulties encountered during operation, and postoperative management of patients as well as morbidity and mortality were recorded and analysed. We observed that the mean age was 40 years. The sex incidence revealed female preponderance in the study (M : F: 1 : 2). Duration of illness in the present study varied from 1 month to 6 years in case of liver hydatid disease. Majority of patients were from rural areas (21) and the remaining (4) from urban areas. Swelling was the most common presenting feature. Incidence of hydatid disease at unusual sites in India is higher than in other parts of the world. PMID:24734188

  7. SGLT2 inhibition in diabetes mellitus: rationale and clinical prospects.

    PubMed

    Ferrannini, Ele; Solini, Anna

    2012-02-07

    This Review covers the rationale, physiological consequences and clinical application of pharmacological sodium-glucose cotransporter 2 (SGLT2) inhibition. In patients with type 2 diabetes mellitus, in whom renal glucose reabsorption might be upregulated, orally active, selective SGLT2 inhibitors improve glycaemic control to a therapeutically useful extent. Chronic administration of several SGLT2 inhibitors dose-dependently lowers HbA(1c) levels by 0.5-1.5% without causing hypoglycaemia. The unique mechanism of action of SGLT2 inhibitors-which does not hinge upon β-cell function or tissue insulin sensitivity-means that they can exert their antihyperglycaemic effects in combination with any other oral antidiabetic drug as well as insulin. Available phase III studies confirm a good tolerability profile. Weight loss owing to urinary calorie leakage may be less than expected, but the negative energy balance offers a valuable clinical benefit. Offloading of sodium can assist blood pressure control. The progressive loss of efficacy in patients with reduced glomerular function will have to be balanced against the possibility of renal protection. The safety issues of genitourinary infections and cancer risk requires careful, proactive monitoring and analysis of robust exposure data, particularly in elderly, frail patients and in patients with impaired kidney function and/or high cardiovascular/cancer risk, who represent an increasing fraction of the population with diabetes mellitus.

  8. 42 CFR 421.505 - Termination and extension of non-random prepayment complex medical review.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... medical review; or (2) When calculation of the error rate indicates that the provider or supplier has... non-random prepayment complex medical review. If the reduction in the error rate is attributed to a 25... billing error are no longer suspended for non-random prepayment complex medical review. (d) Periodic...

  9. 42 CFR 421.505 - Termination and extension of non-random prepayment complex medical review.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... complex medical review. 421.505 Section 421.505 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... § 421.505 Termination and extension of non-random prepayment complex medical review. (a) Timeframe that a provider or supplier must be on non-random prepayment complex medical review. There is no...

  10. Neglected ends: clinical ethics consultation and the prospects for closure.

    PubMed

    Fiester, Autumn

    2015-01-01

    Clinical ethics consultations (CECs) are sometimes deemed complete at the moment when the consultants make a recommendation. In CECs that involve actual ethical conflict, this view of a consult's endpoint runs the risk of overemphasizing the conflict's resolution at the expense of the consult's process, which can have deleterious effects on the various parties in the conflict. This overly narrow focus on reaching a decision or recommendation in consults that involve profound moral disagreement can result in two types of adverse, lingering sequelae: moral distress or negative moral emotions. The problem, succinctly named, is that such consults have insufficient "closure" for patients, families, and providers. To promote closure, and avoid the ills of moral distress and the moral emotions, I argue that CECs need to prioritize assisted conversation between the different stakeholders in these conflicts, what is often referred to as "bioethics mediation."

  11. Variations of Gonadal Veins: Embryological Prospective and Clinical Significance

    PubMed Central

    Gupta, Raman; Aggarwal, Navita

    2015-01-01

    Introduction: An adequate knowledge of anomalies of gonadal veins will help the radiologists and surgeons in recognition and protection of these veins which play major roles in thermo-regulation that is essential for the efficient functioning of testis on which the survival of the human species depends. Aim: The aim of this work is to present an analysis of the anatomical variations of gonadal veins. An effort has also been made to explicate the possible embryological model of development of such variants and to present the variable clinical aspects concerning them. Materials and Methods: Gonadal veins in 60 dissection room cadavers were examined for variations from the classic anatomic description. Result: In the present study, out of 60 cases, male: female ratio was 2:1(40:20) in which no variation was found in ovarian veins. In the 18 (45%) cases, testicular veins showed variations which consist of duplication and atypical drainage. Discussion: Variations of drainage of gonadal vein are due to error of embryological development in venous shift and alteration in anastomotic channel of post-cardinal, supra-cardinal and sub cardinal veins. Conclusion: The gonadal veins present numeric variations as well as variations in its site of drainage, which attributed to the various pathological conditions as varicocele and pelvic congestion syndrome, leading to infertility in patients. Hence, in -depth knowledge of these developmental anomalies of gonadal veins is important. PMID:25859438

  12. [Planning and data analysis in prospective controlled clinical trials (author's transl)].

    PubMed

    Barth, H

    1978-11-01

    Planning of prospective controlled clinical trials in surgery requires the use of test and control groups, sufficiently frequent repetition of experiments, random allocation of patients to the groups (example), and balancing. The descriptive data analysis should be performed in a stepwise manner (list of new data, rank list, range, median, quartiles, histogram, mean value standard deviation). The advantages of the median-quartile-system and the prerequisites for application of various significance tests are pointed out. In the conduct of controlled clinical trials, the consultative role of experimental surgeons is proposed.

  13. Modeling progression risk for smoldering multiple myeloma: results from a prospective clinical study.

    PubMed

    Cherry, Benjamin M; Korde, Neha; Kwok, Mary; Manasanch, Elisabet E; Bhutani, Manisha; Mulquin, Marcia; Zuchlinski, Diamond; Yancey, Mary Ann; Maric, Irina; Calvo, Katherine R; Braylan, Raul; Stetler-Stevenson, Maryalice; Yuan, Constance; Tembhare, Prashant; Zingone, Adriana; Costello, Rene; Roschewski, Mark J; Landgren, Ola

    2013-10-01

    The risk of progression to multiple myeloma (MM) from the precursor condition smoldering MM (SMM) varies considerably among individual patients. Reliable markers for progression to MM are vital to advance the understanding of myeloma precursor disease and for the development of intervention trials designed to delay/prevent MM. The Mayo Clinic and Spanish PETHEMA have proposed models to stratify patient risk based on clinical parameters. The aim of our study was to define the degree of concordance between these two models by comparing the distribution of patients with SMM classified as low, medium and high risk for progression. A total of 77 patients with SMM were enrolled in our prospective natural history study. Per study protocol, each patient was assigned risk scores based on both the Mayo and the Spanish models. The Mayo Clinic model identified 38, 35 and four patients as low, medium and high risk, respectively. The Spanish PETHEMA model classified 17, 22 and 38 patients as low, medium and high risk, respectively. There was significant discordance in overall patient risk classification (28.6% concordance) and in classifying patients as low versus high (p < 0.0001), low versus non-low (p = 0.0007) and high versus non-high (p < 0.0001) risk. There is a need for prospectively validated models to characterize individual patient risk of transformation to MM. PMID:23311294

  14. Clinical Evaluation of Eye Movements in Spinocerebellar Ataxias: A Prospective Multicenter Study

    PubMed Central

    Moscovich, M.; Okun, Michael S.; Favilla, Chris; Figueroa, Karla P.; Pulst, Stefan M.; Perlman, Susan; Wilmot, George; Gomez, Christopher; Schmahmann, Jeremy; Paulson, Henry; Shakkottai, Vikram; Ying, Sarah; Zesiewicz, Theresa; Kuo, S. H.; Mazzoni, P.; Bushara, Khalaf; Xia, Guangbin; Ashizawa, Tetsuo; Subramony, S. H.

    2015-01-01

    Background Ocular motor abnormalities reflect the varied neuropathology of spinocerebellar ataxias (SCAs) and may serve to clinically distinguish the different SCAs. We analyzed the various eye movement abnormalities detected prospectively at the baseline visit during a large multicenter natural history study of SCAs 1, 2, 3, and 6. Methods The data were prospectively collected from 12 centers in the United States in patients with SCAs 1, 2, 3, and 6, as part of the Clinical Research Consortium for Spinocerebellar Ataxias (NIH-CRC-SCA). Patient characteristics, ataxia rating scales, the Unified Huntington Disease Rating Scale functional examination, and clinical staging were used. Eye movement abnormalities including nystagmus, disorders of saccades and pursuit, and ophthalmoparesis were recorded, and factors influencing their occurrence were examined. Results A total of 301 patients participated in this study, including 52 patients with SCA 1, 64 with SCA 2, 117 with SCA 3, and 68 with SCA 6. Although no specific ocular motor abnormality was pathognomonic to any SCA, significant differences were noted in their occurrence among different disorders. SCA 6 was characterized by frequent occurrence of nystagmus and abnormal pursuit and rarity of slow saccades and ophthalmoparesis and SCA 2 by the frequent occurrence of slow saccades and infrequent nystagmus and dysmetric saccades. SCA 1 and SCA 3 subjects had a more even distribution of eye movement abnormalities. Conclusions Prospective data from a large cohort of patients with SCAs 1, 2, 3, and 6 provide statistical validation that the SCAs exhibit distinct eye movement abnormalities that are useful in identifying the genotypes. Many of the abnormalities correlate with greater disease severity measures. PMID:25259863

  15. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

    PubMed Central

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-01-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

  16. CT-guided Percutaneous Laser Disc Decompression (PLDD): prospective clinical outcome

    NASA Astrophysics Data System (ADS)

    Brat, Hugues G.; Bouziane, Tarik; Lambert, Jean; Divano, Luisa

    2004-09-01

    Percutaneous Laser Disc Decompression (PLDD) is a minimal invasive and effective treatment for contained lumbar disc hernias with correspondent radicular pain. This prospective study evaluates clinical efficacy of patients treated with PLDD under CT-fluoroscopic guidance. An independent observer assessed clinical outcome in a series of 40 consecutive patients at a mean follow-up of 7.5 months after treatment. According to Mac Nab criteria, 80% of patients experienced a good response to PLDD, 12.5% a fair response and 7.5% a poor response. 37 patients (92.5%) were back at work after 3 weeks. This technique could represent an alternative and secure treatment to conventional surgery for contained disc hernias.

  17. Clinical, psychological and environmental predictors of prospective suicide events in patients with Bipolar Disorder.

    PubMed

    Antypa, Niki; Antonioli, Marco; Serretti, Alessandro

    2013-11-01

    Patients with Bipolar Disorder (BD) have high rates of suicide compared to the general population. The present study investigates the predictive power of baseline clinical, psychological and environmental characteristics as risk factors of prospective suicide events (attempts and completions). Data was collected from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study. 3083 bipolar patients were included in this report, among these 140 (4.6%) had a suicide event (8 died by suicide and 132 attempted suicide). Evaluation and assessment forms were used to collect clinical, psychological and socio-demographic information. Chi-square and independent t-tests were used to evaluate baseline characteristics. Potential prospective predictors were selected on the basis of prior literature and using a screening analysis of all risk factors that were associated with a history of suicide attempt at baseline and were tested using a Cox regression analysis. The strongest predictor of a suicide event was a history of suicide attempt (hazard ratio = 2.60, p-value < 0.001) in line with prior literature. Additional predictors were: younger age, a high total score on the personality disorder questionnaire and a high percentage of days spent depressed in the year prior to study entry. In conclusion, the present findings may help clinicians to identify patients at high risk for suicidal behavior upon presentation for treatment.

  18. Electrophysiological Predictors of Clinical Outcome in Traumatic Neuropathies: A Multicenter Prospective Study.

    PubMed

    Ciaramitaro, Palma; Mondelli, Mauro; Rota, Eugenia; Battiston, Bruno; Sard, Arman; Pontini, Italo; Faccani, Giuliano; Migliaretti, Giuseppe; Merola, Aristide; Cocito, Dario; Neuropathies, Italian Network For Traumatic

    2016-01-01

    Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX) markers of clinical recovery in patients with traumatic neuropathy (TN) receiving surgical (S) and nonsurgical (NS) treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN) were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients) or secondary surgery (70 patients), according to the clinical spontaneous recovery at 4-6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61-8.76), particularly in the S group (OR 7.25; CI 1.2-43.87), and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14-16.69). No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS) represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process.

  19. Electrophysiological Predictors of Clinical Outcome in Traumatic Neuropathies: A Multicenter Prospective Study.

    PubMed

    Ciaramitaro, Palma; Mondelli, Mauro; Rota, Eugenia; Battiston, Bruno; Sard, Arman; Pontini, Italo; Faccani, Giuliano; Migliaretti, Giuseppe; Merola, Aristide; Cocito, Dario; Neuropathies, Italian Network For Traumatic

    2016-01-01

    Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX) markers of clinical recovery in patients with traumatic neuropathy (TN) receiving surgical (S) and nonsurgical (NS) treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN) were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients) or secondary surgery (70 patients), according to the clinical spontaneous recovery at 4-6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61-8.76), particularly in the S group (OR 7.25; CI 1.2-43.87), and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14-16.69). No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS) represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process. PMID:27547450

  20. Electrophysiological Predictors of Clinical Outcome in Traumatic Neuropathies: A Multicenter Prospective Study

    PubMed Central

    Mondelli, Mauro; Battiston, Bruno; Sard, Arman; Pontini, Italo; Faccani, Giuliano; Migliaretti, Giuseppe; Cocito, Dario; Neuropathies, Italian Network for Traumatic

    2016-01-01

    Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX) markers of clinical recovery in patients with traumatic neuropathy (TN) receiving surgical (S) and nonsurgical (NS) treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN) were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients) or secondary surgery (70 patients), according to the clinical spontaneous recovery at 4–6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61–8.76), particularly in the S group (OR 7.25; CI 1.2–43.87), and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14–16.69). No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS) represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process. PMID:27547450

  1. Efficacy and safety of thalidomide for the treatment of severe recurrent epistaxis in hereditary hemorrhagic telangiectasia: results of a prospective phase II clinical trial

    PubMed Central

    Invernizzi, Rosangela; Quaglia, Federica; Klersy, Caherine; Pagella, Fabio; Ornati, Federica; Chu, Francesco; Matti, Elina; Spinozzi, Giuseppe; Plumitallo, Sara; Grignani, Pierangela; Olivieri, Carla; Bastia, Raffaella; Bellistri, Francesca; Danesino, Cesare; Benazzo, Marco; Balduini, Carlo L

    2016-01-01

    Summary Background Hereditary hemorrhagic telangiectasia (HHT) is a genetic disease that leads to multiregional angiodysplasia. Severe recurrent epistaxis is the most common presentation, frequently leading to severe anemia. Multiple therapeutic approaches have been tried, but they are largely palliative with variable results.We aimed to assess the efficacy of thalidomide in reducing epistaxis in patients with HHT refractory to standard therapy. Methods HHT patients with severe recurrent epistaxis refractory to mini-invasive surgical procedures were included in an open label, phase II, prospective, non-randomized, single-centre study. Thalidomide was administered at a starting dose of 50 mg/day orally. In the event of no response, thalidomide dosage was increased by 50 mg/day every four weeks until response to a maximum dose of 200 mg/day. After response achievement, patients were treated for eight to16 additional weeks. Monthly follow-up was based on the epistaxis severity score and transfusion need, with adverse events being reported (ClinicalTrials.gov Identifier: NCT01485224). Findings Thirty-one patients, mean age 62∙6 (SD 11∙1) years, were enrolled (median follow-up 15∙9 months, 25th-75th 10∙1-22∙3). Treatment induced cessation of bleeding in three cases (9∙7%) and a significant decrease in all epistaxis parameters in 28 cases (90∙3%). Twenty-five patients (80∙7%) obtained remission with 50 mg/day of thalidomide, five (16∙1%) with 100 mg/day and one (3∙2%) with 150 mg/day. Treatment significantly increased hemoglobin levels (p<0∙001), and abolished or greatly decreased the transfusion need (p<0∙001).Only nonserious, grade I, adverse effects were observed, including constipation and drowsiness. Median time to relapse after the end of therapy was 6∙4 months. No correlation was found between genetic or clinical features and response to thalidomide or toxicity. Interpretation Low-dose thalidomide is safe and very effective in reducing

  2. Multiplex Pathogen Identification for Polymicrobial Urinary Tract Infections Using Biosensor Technology: A Prospective Clinical Study

    PubMed Central

    Mach, Kathleen E.; Du, Christine B.; Phull, Hardeep; Haake, David A.; Shih, Mei-Chiung; Baron, Ellen Jo; Liao, Joseph C.

    2014-01-01

    Purpose Rapid diagnosis of urinary tract infection would have a significant beneficial impact on clinical management, particularly in patients with structural or functional urinary tract abnormalities who are highly susceptible to recurrent polymicrobial infections. We examined the analytical validity of an electrochemical biosensor array for rapid molecular diagnosis of urinary tract infection in a prospective clinical study in patients with neurogenic bladder. Materials and Methods The electrochemical biosensor array was functionalized with DNA probes against 16S rRNA of the most common uropathogens. Spinal cord injured patients at a Veterans Affairs hospital were recruited into the study. Urine samples were generally tested on the biosensor within 1 to 2 hours of collection. Biosensor results were compared with those obtained using standard clinical microbiology laboratory methods. Results We successfully developed a 1-hour biosensor assay for multiplex identification of pathogens. From July 2007 to December 2008 we recruited 116 patients, yielding a total of 109 urine samples suitable for analysis and comparison between biosensor assay and standard urine culture. Of the samples 74% were positive, of which 42% were polymicrobial. We identified 20 organisms, of which Escherichia coli, Pseudomonas aeruginosa and Enterococcus species were the most common. Biosensor assay specificity and positive predictive value were 100%. Pathogen detection sensitivity was 89%, yielding a 76% negative predictive value. Conclusions To our knowledge we report the first prospective clinical study to successfully identify pathogens within a point of care time frame using an electrochemical biosensor platform. Additional efforts to improve the limit of detection and probe design are needed to further enhance assay sensitivity. PMID:19837423

  3. Non-random structures in universal compression and the Fermi paradox

    NASA Astrophysics Data System (ADS)

    Gurzadyan, A. V.; Allahverdyan, A. E.

    2016-02-01

    We study the hypothesis of information panspermia assigned recently among possible solutions of the Fermi paradox ("where are the aliens?"). It suggests that the expenses of alien signaling can be significantly reduced, if their messages contained compressed information. To this end we consider universal compression and decoding mechanisms ( e.g. the Lempel-Ziv-Welch algorithm) that can reveal non-random structures in compressed bit strings. The efficiency of the Kolmogorov stochasticity parameter for detection of non-randomness is illustrated, along with the Zipf's law. The universality of these methods, i.e. independence from data details, can be principal in searching for intelligent messages.

  4. [Anterior cervical fusion with tantalum interbody implants. Clinical and radiological results in a prospective study].

    PubMed

    Vicario, C; Lopez-Oliva, F; Sánchez-Lorente, T; Zimmermann, M; Asenjo-Siguero, J J; Ladero, F; Ibarzábal, A

    2006-04-01

    Anterior cervical discectomy and interbody fusion (ACDF) is a widely accepted surgical technique in the treatment of cervical disc disease. Tantalum cages have been recently introduced in spine surgery for interbody fusion because of the advantages of their mechanical properties. We present the results of a prospective clinical and radiological study on 24 consecutive patients who underwent an ACDF with tantalum cages. Clinical evaluation was assessed preoperatively and after surgery by a questionnaire that included a Visual Analogic Scale (VAS) of neck and arm pain, the Oswestry Disability Index and the Zung Depression Scale. Results were classified by Odom's criteria. Radiological evaluation included flexion-extension X-rays, and changes in distance between spinous processes and Cobb angle were measured. Postoperatively patients were reviewed 3 and 12 months after surgery. A statistical significative improvement in all clinical data was reported. According to Odom's criteria in 75% of patients the results were considered like excellent or good. Only one case of radiological and clinical pseudoarthrosis was confirmed. No significative differences were reported 3 and 12 months after surgery. Tantalum cages are a very promising and usefull alternative among implants available for ACDF. Compatibility with MRI postoperative studies and the unnecessariness of autograft are some of their advantages. PMID:16721480

  5. Clinical outcome of intracytoplasmic injection of spermatozoa morphologically selected under high magnification: a prospective randomized study.

    PubMed

    Balaban, Basak; Yakin, Kayhan; Alatas, Cengiz; Oktem, Ozgur; Isiklar, Aycan; Urman, Bulent

    2011-05-01

    Recent evidence shows that the selection of spermatozoa based on the analysis of morphology under high magnification (×6000) may have a positive impact on embryo development in cases with severe male factor infertility and/or previous implantation failures. The objective of this prospective randomized study was to compare the clinical outcome of 87 intracytoplasmic morphologically selected sperm injection (IMSI) cycles with 81 conventional intracytoplasmic sperm injection (ICSI) cycles in an unselected infertile population. IMSI did not provide a significant improvement in the clinical outcome compared with ICSI although there were trends for higher implantation (28.9% versus 19.5%), clinical pregnancy (54.0% versus 44.4%) and live birth rates (43.7% versus 38.3%) in the IMSI group. However, severe male factor patients benefited from the IMSI procedure as shown by significantly higher implantation rates compared with their counterparts in the ICSI group (29.6% versus 15.2%, P=0.01). These results suggest that IMSI may improve IVF success rates in a selected group of patients with male factor infertility. New technological developments enable the real time examination of motile spermatozoa with an inverted light microscope equipped with high-power differential interference contrast optics, enhanced by digital imaging. High magnification (over ×6000) provides the identification of spermatozoa with a normal nucleus and nuclear content. Intracytoplasmic injection of spermatozoa selected according to fine nuclear morphology under high magnification may improve the clinical outcome in cases with severe male factor infertility.

  6. [Anterior cervical fusion with tantalum interbody implants. Clinical and radiological results in a prospective study].

    PubMed

    Vicario, C; Lopez-Oliva, F; Sánchez-Lorente, T; Zimmermann, M; Asenjo-Siguero, J J; Ladero, F; Ibarzábal, A

    2006-04-01

    Anterior cervical discectomy and interbody fusion (ACDF) is a widely accepted surgical technique in the treatment of cervical disc disease. Tantalum cages have been recently introduced in spine surgery for interbody fusion because of the advantages of their mechanical properties. We present the results of a prospective clinical and radiological study on 24 consecutive patients who underwent an ACDF with tantalum cages. Clinical evaluation was assessed preoperatively and after surgery by a questionnaire that included a Visual Analogic Scale (VAS) of neck and arm pain, the Oswestry Disability Index and the Zung Depression Scale. Results were classified by Odom's criteria. Radiological evaluation included flexion-extension X-rays, and changes in distance between spinous processes and Cobb angle were measured. Postoperatively patients were reviewed 3 and 12 months after surgery. A statistical significative improvement in all clinical data was reported. According to Odom's criteria in 75% of patients the results were considered like excellent or good. Only one case of radiological and clinical pseudoarthrosis was confirmed. No significative differences were reported 3 and 12 months after surgery. Tantalum cages are a very promising and usefull alternative among implants available for ACDF. Compatibility with MRI postoperative studies and the unnecessariness of autograft are some of their advantages.

  7. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    SciTech Connect

    Schwartz, David L.; Garden, Adam S.; Thomas, Jimmy; Chen Yipei; Zhang Yongbin; Lewin, Jan; Chambers, Mark S.; Dong, Lei

    2012-07-01

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  8. The clinical outcomes of chronic hepatitis C in South Korea: A prospective, multicenter cohort study.

    PubMed

    Ok, Kyeong Sam; Jeong, Sook-Hyang; Jang, Eun Sun; Kim, Young Seok; Lee, Youn Jae; Kim, In Hee; Cho, Sung Bum; Bae, Si Hyun; Lee, Han Chu

    2016-08-01

    This prospective cohort study aimed to elucidate the clinical outcome and its related factors of chronic hepatitis C in a hepatitis B-dominant Asian region.From January 2007 to October 2012, 382 patients with chronic hepatitis C without liver cirrhosis were prospectively enrolled at 6 university hospitals, and regularly followed until Apr 2014 to identify the development of liver cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC), and overall survival.During the median follow-up of 39.0 months (range 18.0-81.0 months), liver cirrhosis, hepatic decompensation, and HCC developed in 42 patients (11.0%), 4 patients (1.0%), and 12 patients (3.1%), respectively. The cumulative probability of development of cirrhosis at 3 years and at 5 years was 9.6% and 16.7%, respectively. That of HCC at 3 and 5 years was 1.6% and 4.5%, respectively. The 3-year and 5-year overall survival rate was 99.7% and 96.0%, respectively. Pegylated interferon-based antiviral therapy was undertaken in 237 patients (62.0%) with a sustained virologic response (SVR) rate of 74.3%. The factors related to the overall clinical outcomes were age ≥55 years (HR 2.924, P = 0.016), platelet counts <150  × 10/L (HR 3.195, P = 0.007), and the achievement of SVR (HR 0.254, P = 0.002).The clinical outcomes of this Korean chronic hepatitis C cohort were modest with minimal mortality, but significant disease progression occurred in the patients with old age, low platelet, and non-SVR after interferon-based antiviral treatment or no treatment, suggesting priority for direct acting antiviral therapy. PMID:27583874

  9. The clinical outcomes of chronic hepatitis C in South Korea: A prospective, multicenter cohort study.

    PubMed

    Ok, Kyeong Sam; Jeong, Sook-Hyang; Jang, Eun Sun; Kim, Young Seok; Lee, Youn Jae; Kim, In Hee; Cho, Sung Bum; Bae, Si Hyun; Lee, Han Chu

    2016-08-01

    This prospective cohort study aimed to elucidate the clinical outcome and its related factors of chronic hepatitis C in a hepatitis B-dominant Asian region.From January 2007 to October 2012, 382 patients with chronic hepatitis C without liver cirrhosis were prospectively enrolled at 6 university hospitals, and regularly followed until Apr 2014 to identify the development of liver cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC), and overall survival.During the median follow-up of 39.0 months (range 18.0-81.0 months), liver cirrhosis, hepatic decompensation, and HCC developed in 42 patients (11.0%), 4 patients (1.0%), and 12 patients (3.1%), respectively. The cumulative probability of development of cirrhosis at 3 years and at 5 years was 9.6% and 16.7%, respectively. That of HCC at 3 and 5 years was 1.6% and 4.5%, respectively. The 3-year and 5-year overall survival rate was 99.7% and 96.0%, respectively. Pegylated interferon-based antiviral therapy was undertaken in 237 patients (62.0%) with a sustained virologic response (SVR) rate of 74.3%. The factors related to the overall clinical outcomes were age ≥55 years (HR 2.924, P = 0.016), platelet counts <150  × 10/L (HR 3.195, P = 0.007), and the achievement of SVR (HR 0.254, P = 0.002).The clinical outcomes of this Korean chronic hepatitis C cohort were modest with minimal mortality, but significant disease progression occurred in the patients with old age, low platelet, and non-SVR after interferon-based antiviral treatment or no treatment, suggesting priority for direct acting antiviral therapy.

  10. Pre-clinical and clinical experiences with novel somatostatin ligands: advantages, disadvantages and new prospects.

    PubMed

    Hofland, L J; van der Hoek, J; Feelders, R; van der Lely, A J; de Herder, W; Lamberts, S W J

    2005-01-01

    Since the cloning and characterization of the five human somatostatin receptor (SSTR) subtypes, our understanding of the expression and functional role of the five SSTR subtypes in human (neuro-)endocrine tumors has increased significantly. The majority of human (neuro-)endocrine tumors express multiple SSTR. GH-secreting pituitary adenomas preferentially express SSTR2 and SSTR5, prolactinomas SSTR1 and SSTR5, and corticotroph adenomas express SSTR2 (low number) and predominantly SSTR5s. In addition, gastroenteropancreatic (GEP) neuroendocrine tumors frequently express multiple SSTR as well, with SSTR2 being expressed at the highest level. Treatment with the current generation of octapeptide somatostatin-analogs, e.g. octreotide and lanreotide, normalizes circulating GH- and IGF-I levels in approximately 60-70% of acromegalic patients, thereby remaining about one-third of patients uncontrolled. In patients with GEP neuroendocrine tumors, both somatostatin-analogs effectively suppress the production of bioactive peptides and hormones by the tumor cells, resulting in an important improvement of the related clinical symptomatology. However, a considerable proportion of patients experience an escape from treatment within months to several years. Altogether, the current generation of somatostatin analogs are effective medical tools in the treatment of acromegalic patients and of patients with neuroendocrine GEP tumors, but there is certainly a need for novel somatostatin analogs. In recent years, a significant number of novel somatostatin-ligands has been developed. These ligands include SSTR selective-, bi-specific, universal, as well as chimeric dopamine (DA)-somatostatin ligands. In vitro studies using human pituitary adenoma cells demonstrate a more profound inhibition of GH, PRL and ACTH secretion by somatostatin-analogs targeting both SSTR2s and SSTR5s, compared with SSTR2-preferential somatostatin-analogs. This likely reflects the SSTR subtype expression pattern

  11. Bayesian hierarchical modeling for a non-randomized, longitudinal fall prevention trial with spatially correlated observations

    PubMed Central

    Murphy, T. E.; Allore, H. G.; Leo-Summers, L.; Carlin, B. P.

    2012-01-01

    Because randomization of participants is often not feasible in community-based health interventions, non-randomized designs are commonly employed. Non-randomized designs may have experimental units that are spatial in nature, such as zip codes that are characterized by aggregate statistics from sources like the U.S. census and the Centers for Medicare and Medicaid Services. A perennial concern with non-randomized designs is that even after careful balancing of influential covariates, bias may arise from unmeasured factors. In addition to facilitating the analysis of interventional designs based on spatial units, Bayesian hierarchical modeling can quantify unmeasured variability with spatially correlated residual terms. Graphical analysis of these spatial residuals demonstrates whether variability from unmeasured covariates is likely to bias the estimates of interventional effect. The Connecticut Collaboration for Fall Prevention is the first large-scale longitudinal trial of a community-wide healthcare intervention designed to prevent injurious falls in older adults. Over a two-year evaluation phase, this trial demonstrated a rate of fall-related utilization at hospitals and emergency departments by persons 70 years and older in the intervention area that was 11 per cent less than that of the usual care area, and a 9 per cent lower rate of utilization from serious injuries. We describe the Bayesian hierarchical analysis of this non-randomized intervention with emphasis on its spatial and longitudinal characteristics. We also compare several models, using posterior predictive simulations and maps of spatial residuals. PMID:21294148

  12. Prospective randomized clinical study of arterial pumps used for routine on pump coronary bypass grafting.

    PubMed

    Keyser, Andreas; Hilker, Michael K; Diez, Claudius; Philipp, Alois; Foltan, Maik; Schmid, Christof

    2011-05-01

    In a number of studies, centrifugal blood pumps--in comparison with roller pumps--have been shown to attenuate trauma to blood components. Nevertheless, the impact of these results on the postoperative course needs to be discussed controversially. In a prospective randomized study, 240 consecutive adult patients underwent elective myocardial revascularization with cardiopulmonary bypass employing five different pumps (Roller, Avecor, Sarns, Rotaflow, Bio-Medicus). We analyzed clinical course, blood loss, damage of blood components, and impairment of the hemostatic system. The study population was homogenous with respect to age, gender, myocardial function, and operative data. No differences were found with respect to time of ventilation, duration of intensive care stay, hospitalization, and laboratory data. The choice of arterial pump during standard extracorporeal bypass for elective coronary artery bypass grafting is no matter of concern.

  13. Clinical and socio-cultural parameters in Nigerian psychiatric patients. A prospective study.

    PubMed

    Makanjuola, R O

    1985-12-01

    Three hundred and eighteen consecutive new patients presenting at a psychiatric unit in Yorubaland were prospectively studied. The majority were young, and the sexes were equally represented. Most patients came from within 50 km of the unit. Most were brought by their blood-relatives. Significant delay before presentation was observed in most cases. Previous treatment by religious and/or traditional healers was common. According to the DSM-III classification, the majority suffered from functional psychoses, most commonly schizophrenia. Three quarters received neuroleptic medication. The immediate clinical outcome was good in the majority of cases; however, within 6 months of presentation almost half defaulted from treatment. Variables which appeared to be related to delay in presentation, prior treatment by religious or traditional healers and defaulting are presented.

  14. Prospective clinical study of press-ceramic overlap and full veneer restorations: 7-year results.

    PubMed

    Guess, Petra C; Selz, Christian F; Voulgarakis, Apostolos; Stampf, Susanne; Stappert, Christian F J

    2014-01-01

    The aim of this prospective clinical study was to investigate the long-term performance of all-ceramic veneers with overlap (OV) and full veneer (FV) preparation designs. Twenty-five patients were restored using 42 OV restorations (incisal/palatal butt-joint margin) and 24 FV restorations (palatal rounded shoulder margin). All restorations were leucite-reinforced glass-ceramic anterior veneers. The 7-year Kaplan-Meier survival rate was 100% for FV restorations and 97.6% for OV restorations. The all-ceramic veneers revealed significant deterioration over time according to United States Public Health Service criteria, irrespective of the preparation design. Based on the 7-year results of this study, both preparation designs can be considered reliable treatment options for anterior teeth with extended deficits.

  15. The shoulder-hand syndrome after stroke: a prospective clinical trial.

    PubMed

    Braus, D F; Krauss, J K; Strobel, J

    1994-11-01

    Shoulder-hand syndrome developed in 36 (27%) of 132 hemiplegic patients in a prospective study. Subluxation, paresis of the shoulder girdle, moderate spasticity, and deficits in confrontation visual field testing were the major risk factors. In a placebo-controlled, nonblinded trial, 31 of the 36 patients became almost symptom free within 10 days' treatment with low doses of oral corticosteroids. Shoulder joint capsules taken at autopsy of 7 patients showed signs of previous trauma of the affected shoulder. In the second part of this study on another 86 patients, early awareness of potential injuries to shoulder joint structures reduced the frequency of shoulder-hand syndrome from 27 to 8%. These clinical findings suggest that shoulder-hand syndrome in hemiplegia is initiated by peripheral lesions. A self-perpetuating vicious cycle may be established, followed by the clinical picture of a "reflex sympathetic dystrophy." In the majority of stroke patients, this clinical phenomenon seems to be preventable by avoiding shoulder trauma.

  16. Clinical Applications of Brain-Computer Interfaces: Current State and Future Prospects

    PubMed Central

    Mak, Joseph N.; Wolpaw, Jonathan R.

    2009-01-01

    Brain-computer interfaces (BCIs) allow their users to communicate or control external devices using brain signals rather than the brain's normal output pathways of peripheral nerves and muscles. Motivated by the hope of restoring independence to severely disabled individuals and by interest in further extending human control of external systems, researchers from many fields are engaged in this challenging new work. BCI research and development have grown explosively over the past two decades. Efforts have recently begun to provide laboratory-validated BCI systems to severely disabled individuals for real-world applications. In this review, we discuss the current status and future prospects of BCI technology and its clinical applications. We will define BCI, review the BCI-relevant signals from the human brain, and describe the functional components of BCIs. We will also review current clinical applications of BCI technology, and identify potential users and potential applications. Finally, we will discuss current limitations of BCI technology, impediments to its widespread clinical use, and expectations for the future. PMID:20442804

  17. Adaptive Radiotherapy for Head and Neck Cancer: Initial Clinical Outcomes from a Prospective Trial

    PubMed Central

    Schwartz, David L.; Garden, Adam S.; Thomas, Jimmy; Chen, Yipei; Zhang, Yongbin; Lewin, Jan; Chambers, Mark S.; Dong, Lei

    2011-01-01

    Purpose To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods Twenty-four patients enrolled onto an IRB-approved clinical trial. Twenty-two patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of CTVs and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6, and glossopharyngeal sulcus in 1. Twenty (91%) patients had AJCC stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4 and N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Twenty-one (95%) patients received systemic therapy. Results With 31 month median follow up (range: 13-45), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to conventional IMRT results. Chronic toxicity and functional outcomes beyond 1 year were tabulated. Discussion This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head and neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only 1 or 2 mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at one-year follow-up and beyond. PMID:22138459

  18. Plasma C-Reactive Protein and Clinical Outcomes after Acute Ischemic Stroke: A Prospective Observational Study

    PubMed Central

    Matsuo, Ryu; Ago, Tetsuro; Hata, Jun; Wakisaka, Yoshinobu; Kuroda, Junya; Kuwashiro, Takahiro; Kitazono, Takanari; Kamouchi, Masahiro

    2016-01-01

    Background and Purpose Although plasma C-reactive protein (CRP) is elevated in response to inflammation caused by brain infarction, the association of CRP with clinical outcomes after acute ischemic stroke remains uncertain. This study examined whether plasma high-sensitivity CRP (hsCRP) levels at onset were associated with clinical outcomes after acute ischemic stroke independent of conventional risk factors and acute infections after stroke. Methods We prospectively included 3653 patients with first-ever ischemic stroke who had been functionally independent and were hospitalized within 24 h of onset. Plasma hsCRP levels were measured on admission and categorized into quartiles. The association between hsCRP levels and clinical outcomes, including neurological improvement, neurological deterioration, and poor functional outcome (modified Rankin scale ≥3 at 3 months), were investigated using a logistic regression analysis. Results Higher hsCRP levels were significantly associated with unfavorable outcomes after adjusting for age, sex, baseline National Institutes of Health Stroke Scale score, stroke subtype, conventional risk factors, intravenous thrombolysis and endovascular therapy, and acute infections during hospitalization (multivariate-adjusted odds ratios [95% confidence interval] in the highest quartile versus the lowest quartile as a reference: 0.80 [0.65–0.97] for neurological improvement, 1.72 [1.26–2.34] for neurological deterioration, and 2.03 [1.55–2.67] for a poor functional outcome). These associations were unchanged after excluding patients with infectious diseases occurring during hospitalization, or those with stroke recurrence or death. These trends were similar irrespective of stroke subtypes or baseline stroke severity, but more marked in patients aged <70 years (Pheterogeneity = 0.001). Conclusions High plasma hsCRP is independently associated with unfavorable clinical outcomes after acute ischemic stroke. PMID:27258004

  19. Clinical Profile of Diabetic Ketoacidosis: A Prospective Study in a Tertiary Care Hospital

    PubMed Central

    Seth, Pankaj; Kaur, Maneet

    2015-01-01

    Background Diabetic ketoacidosis, a well-known and major acute metabolic complication classically occurs in young patients with type 1 diabetes. However, it may occur in patients with type 2 Diabetes Mellitus too. Objective Aim of this study was to look into the clinical profile, precipitating factors and clinical outcome in the patients presenting with Diabetic ketoacidosis in the Emergency of a Tertiary care hospital. Design The study was a prospective study conducted over a period of two years in Kasturba Medical College, Manipal Karnataka, India. Materials and Methods Clinical profile of 60 diabetic patients admitted in the Emergency with the diagnosis of Diabetic ketoacidosis were analysed. Results Out of 60 patients, 12 were of Type 1 and 48 were Type 2 Diabetes Mellitus. Mean duration of diabetes was 8.65 years. Only 14 (23.3%) patients were taking regular treatment for Diabetes Mellitus whereas 32 (53.33%) patients were on irregular treatment and eight (13.33%) were not on any treatment at all. Among 12 Type 1 Diabetic patients, six patients were freshly diagnosed to be diabetic when they presented with Diabetic ketoacidosis complication. Nausea and vomiting (63.33%) were the most common symptoms of these patients. Infections (73.33%) were the most common precipitating factor for Diabetic ketoacidosis. Mean fluid requirement on first day of therapy was 3.51 liters. Mortality of 10% was seen. Conclusion Diabetic ketoacidosis is a fatal acute metabolic complication of Diabetes Mellitus with heterogeneous clinical presentation. Early diagnosis and treatment can avoid morbidity & mortality. PMID:26266145

  20. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study

    PubMed Central

    Plasseraud, Kristen Meldi; Tsai, Tony; Shildkrot, Yevgeniy; Middlebrook, Brooke; Maetzold, Derek; Wilkinson, Jeff; Stone, John; Johnson, Clare; Oelschlager, Kristen; Aaberg, Thomas M.

    2016-01-01

    Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p = 0.003) with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher's exact test p = 2.1 × 10−13 and p = 0.04, resp.). The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920). PMID:27446211

  1. Psorinum therapy in treating stomach, gall bladder, pancreatic, and liver cancers: a prospective clinical study.

    PubMed

    Chatterjee, Aradeep; Biswas, Jaydip; Chatterjee, Ashim; Bhattacharya, Sudin; Mukhopadhyay, Bishnu; Mandal, Syamsundar

    2011-01-01

    We prospectively studied the clinical efficacy of an alternative cancer treatment "Psorinum Therapy" in treating stomach, gall bladder, pancreatic and liver cancers. Our study was observational, open level and single arm. The participants' eligibility criteria included histopathology/cytopathology confirmation of malignancy, inoperable tumor, and no prior chemotherapy or radiation therapy. The primary outcome measures of the study were (i) to assess the radiological tumor response (ii) to find out how many participants survived at least 1 year, 2 years, 3 years, 4 years and finally 5 years after the beginning of the study considering each type of cancer. Psorinum-6x was administered orally to all the participants up to 0.02 ml/Kg body weight as a single dose in empty stomach per day for 2 years along with allopathic and homeopathic supportive cares. 158 participants (42 of stomach, 40 of gall bladder, 44 of pancreatic, 32 of liver) were included in the final analysis of the study. Complete tumor response occurred in 28 (17.72%) cases and partial tumor response occurred in 56 (35.44%) cases. Double-blind randomized controlled clinical trial should be conducted for further scientific exploration of this alternative cancer treatment.

  2. Psorinum Therapy in Treating Stomach, Gall Bladder, Pancreatic, and Liver Cancers: A Prospective Clinical Study

    PubMed Central

    Chatterjee, Aradeep; Biswas, Jaydip; Chatterjee, Ashim; Bhattacharya, Sudin; Mukhopadhyay, Bishnu; Mandal, Syamsundar

    2011-01-01

    We prospectively studied the clinical efficacy of an alternative cancer treatment “Psorinum Therapy” in treating stomach, gall bladder, pancreatic and liver cancers. Our study was observational, open level and single arm. The participants' eligibility criteria included histopathology/cytopathology confirmation of malignancy, inoperable tumor, and no prior chemotherapy or radiation therapy. The primary outcome measures of the study were (i) to assess the radiological tumor response (ii) to find out how many participants survived at least 1 year, 2 years, 3 years, 4 years and finally 5 years after the beginning of the study considering each type of cancer. Psorinum-6x was administered orally to all the participants up to 0.02 ml/Kg body weight as a single dose in empty stomach per day for 2 years along with allopathic and homeopathic supportive cares. 158 participants (42 of stomach, 40 of gall bladder, 44 of pancreatic, 32 of liver) were included in the final analysis of the study. Complete tumor response occurred in 28 (17.72%) cases and partial tumor response occurred in 56 (35.44%) cases. Double-blind randomized controlled clinical trial should be conducted for further scientific exploration of this alternative cancer treatment. PMID:21197093

  3. Incidence and clinical significance of bone bruises after supination injury of the ankle. A double-blind, prospective study.

    PubMed

    Alanen, V; Taimela, S; Kinnunen, J; Koskinen, S K; Karaharju, E

    1998-05-01

    We used MRI to study a prospective series of 95 patients with inversion injuries of the ankle and no fracture on plain radiographs. We found an incidence of bone bruises of 27%, but these made no difference to the time of return to work, limitation of walking or physical activity, or the clinical outcome scores at three months. We conclude that bone bruises have very little clinical significance after inversion injuries of the ankle.

  4. Integrated safety of levodopa‐carbidopa intestinal gel from prospective clinical trials

    PubMed Central

    Rodriguez, Ramon L.; Boyd, James T.; Chouinard, Sylvain; Zadikoff, Cindy; Espay, Alberto J.; Slevin, John T.; Fernandez, Hubert H.; Lew, Mark F.; Stein, David A.; Odin, Per; Fung, Victor S.C.; Klostermann, Fabian; Fasano, Alfonso; Draganov, Peter V.; Schmulewitz, Nathan; Robieson, Weining Z.; Eaton, Susan; Chatamra, Krai; Benesh, Janet A.; Dubow, Jordan

    2015-01-01

    ABSTRACT Background Continuous administration of levodopa‐carbidopa intestinal gel (carbidopa‐levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy. Methods Safety data from 4 studies were summarized using 2 overlapping data sets, permitting the separation of procedure/device–associated (n = 395) from non‐procedure/device adverse events (n = 412). Results At the data cutoff, median exposure to levodopa‐carbidopa intestinal gel was 911 days (range, 1‐1980 days) with 963 total patient‐years of exposure. Procedure/device adverse events occurred in 300 patients (76%), and serious adverse events occurred in 68 (17%); most frequently reported procedure/device adverse events and serious adverse events were complications of device insertion (41% and 8%, respectively) and abdominal pain (36% and 4%, respectively). Non‐procedure/device adverse events occurred in 92% (379), with most frequently reported being insomnia (23%) and falls (23%); 42% (171) had non‐procedure/device serious adverse events, with most frequently reported being pneumonia (5%) and PD symptoms (2%). Adverse events led to discontinuation in 17% (72), most frequently because of complication of device insertion (2.4%). There were 34 treatment‐emergent deaths (8.3%) in the overlapping data sets, 2 of which (0.5%) were considered “possibly related” to the treatment system. Conclusion In the largest collection of levodopa‐carbidopa intestinal gel safety data from prospective clinical studies, procedure/device events were frequently reported and occasionally life threatening. Most non‐procedure/device events were typical for levodopa treatment and an elderly population. These factors combined with high treatment efficacy led to a

  5. Predictive value of endometrial thickness, pattern and sub-endometrial blood flows on the day of hCG by 2D doppler in in-vitro fertilization cycles: A prospective clinical study from a tertiary care unit

    PubMed Central

    Singh, Neeta; Bahadur, Anupama; Mittal, Suneeta; Malhotra, Neena; Bhatt, Ashok

    2011-01-01

    AIMS AND OBJECTIVES: To evaluate the role of endometrial thickness, pattern and sub-endometrial blood flows measured by 2D power Doppler ultrasound to predict pregnancy during in-vitro fertilization (IVF) treatment. STUDY DESIGN: Prospective, non-randomized clinical study. MATERIALS AND METHODS: This was a prospective observational study. A total of 101 infertile women were recruited from our IVF-ET program from January to December, 2009. Women with tubal factor, male factor and unexplained infertility were included in the study. RESULTS: The mean age was 35 years and mean duration of infertility was 8 years. Seventy five (74.25%) patients had primary infertility and 26 (25.74%) had secondary infertility. The mean endometrial thickness was 8.1 mm and endometrial blood flow was in Zone I in 18 patients, 28 patients had blood flow in Zone II and 54 had in Zone III. Overall, 27 (26.73%) patients conceived and in these women the endometrial thickness was between 6 and 12 mm. CONCLUSIONS: With a thin endometrium (≤7 mm) and no-triple-line endometrial pattern coexisting in an in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) candidate, cryopreservation should be recommended. With a thin endometrium and a good texture (triple-line), other prognostic factors, such as embryo quality, should be taken into account. The endometrial vascularity has a useful predictive value on the implantation rate in IVF cycles irrespective of the morphological appearance of the endometrium. However, further study is needed to make a definitive conclusion. PMID:21772737

  6. Checklists of Methodological Issues for Review Authors to Consider When Including Non-Randomized Studies in Systematic Reviews

    ERIC Educational Resources Information Center

    Wells, George A.; Shea, Beverley; Higgins, Julian P. T.; Sterne, Jonathan; Tugwell, Peter; Reeves, Barnaby C.

    2013-01-01

    Background: There is increasing interest from review authors about including non-randomized studies (NRS) in their systematic reviews of health care interventions. This series from the Ottawa Non-Randomized Studies Workshop consists of six papers identifying methodological issues when doing this. Aim: To format the guidance from the preceding…

  7. Clinical history for diagnosis of dementia in men: Caerphilly Prospective Study

    PubMed Central

    Creavin, Sam; Fish, Mark; Gallacher, John; Bayer, Antony; Ben-Shlomo, Yoav

    2015-01-01

    Background Diagnosis of dementia often requires specialist referral and detailed, time-consuming assessments. Aim To investigate the utility of simple clinical items that non-specialist clinicians could use, in addition to routine practice, to diagnose all-cause dementia syndrome. Design and setting Cross-sectional diagnostic test accuracy study. Participants were identified from the electoral roll and general practice lists in Caerphilly and adjoining villages in South Wales, UK. Method Participants (1225 men aged 45–59 years) were screened for cognitive impairment using the Cambridge Cognitive Examination, CAMCOG, at phase 5 of the Caerphilly Prospective Study (CaPS). Index tests were a standardised clinical evaluation, neurological examination, and individual items on the Informant Questionnaire for Cognitive Disorders in the Elderly (IQCODE). Results Two-hundred and five men who screened positive (68%) and 45 (4.8%) who screened negative were seen, with 59 diagnosed with dementia. The model comprising problems with personal finance and planning had an area under the curve (AUC) of 0.92 (95% confidence interval [CI] = 0.86 to 0.97), positive likelihood ratio (LR+) of 23.7 (95% CI = 5.88 to 95.6), negative likelihood ratio (LR−) of 0.41 (95% CI = 0.27 to 0.62). The best single item for ruling out was no problems learning to use new gadgets (LR− of 0.22, 95% CI = 0.11 to 0.43). Conclusion This study found that three simple questions have high utility for diagnosing dementia in men who are cognitively screened. If confirmed, this could lead to less burdensome assessment where clinical assessment suggests possible dementia. PMID:26212844

  8. A prospective study of the clinical findings, treatment and histopathology of 44 cases of pyotraumatic dermatitis.

    PubMed

    Holm, Birgit R; Rest, Joan R; Seewald, Wolfgang

    2004-12-01

    Pyotraumatic dermatitis (hot spot) is a common clinical syndrome in dogs but there are few prospective scientific studies related to it. The aim of this study was to investigate correlations among clinical pyotraumatic dermatitis, histopathology of the lesions and possible predisposing causes. The relationship of these with breed, age, sex and location of lesion was assessed statistically. A clinical diagnosis of acute pyotraumatic dermatitis was made in 44 privately owned dogs. Males exceeded females (P = 0.0348) and lesions were more common in dogs aged 4 years or less (P < 0.0001). Lesions were most often seen on the cheek, neck and lateral thigh with a significant correlation between breed and site of lesion (P < 0.0001). In 31 cases a possible underlying cause was found or suspected. In contrast to previous studies, no otitis externa was recorded and the study was conducted in an area without endemic fleas. Fourteen breeds were represented of which Rottweiler, German shepherd dog and golden retriever were most common. There was no significant seasonal incidence and no correlation among site of lesion and cause, time of year, age or sex. Histopathologically, the dogs could be separated into four patterns by the presence or absence of eosinophils and/or folliculitis. Eosinophils have not previously been recorded in pyotraumatic dermatitis but were seen in 29 cases. Acute folliculitis was seen in 20 cases. However, no correlation was seen among age, sex, breed, underlying cause or site of lesion and histopathology. Twenty-seven cases were cultured for bacteria of which 25 grew Staphylococcus intermedius and two were negative.

  9. Multidisciplinary Team Contributions Within a Dedicated Outpatient Palliative Radiotherapy Clinic: A Prospective Descriptive Study

    SciTech Connect

    Pituskin, Edith; Fairchild, Alysa; Dutka, Jennifer; Gagnon, Lori; Driga, Amy; Tachynski, Patty; Borschneck, Jo-Ann; Ghosh, Sunita

    2010-10-01

    Purpose: Patients with bone metastases may experience pain, fatigue, and decreased mobility. Multiple medications for analgesia are often required, each with attendant side effects. Although palliative-intent radiotherapy (RT) is effective in decreasing pain, additional supportive care interventions may be overlooked. Our objective was to describe the feasibility of multidisciplinary assessment of patients with symptomatic bone metastases attending a dedicated outpatient palliative RT clinic. Methods and Materials: Consecutive patients referred for RT for painful bone metastases were screened for symptoms and needs relevant to their medications, nutritional intake, activities of daily living, and psychosocial and spiritual concerns from January 1 to December 31, 2007. Consultations by appropriate team members and resulting recommendations were collected prospectively. Patients who received RT were contacted by telephone 4 weeks later to assess symptom outcomes. Results: A total of 106 clinic visits by 82 individual patients occurred. As determined by screening form responses, the clinical Pharmacist, Occupational Therapist, Registered Dietician and Social Worker were consulted to provide assessments and recommendations within the time constraints presented by 1-day palliative RT delivery. In addition to pain relief, significant improvements in tiredness, depression, anxiety, drowsiness and overall well-being were reported at 4 weeks. Conclusions: Systematic screening of this population revealed previously unmet needs, addressed in the form of custom verbal and written recommendations. Multidisciplinary assessment is associated with a high number of recommendations and decreased symptom distress. Our findings lend strong support to the routine assessment by multiple supportive care professionals for patients with advanced cancer being considered for palliative RT.

  10. Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study

    PubMed Central

    Haaverstad, Rune; Vitale, Nicola; Karevold, Asbjørn; Cappabianca, Giangiuseppe; Tromsdal, Arve; Olsen, Peter Skov; Köber, Lars; Ihlen, Halfdan; Rein, Kjell Arne; Svennevig, Jan L

    2007-01-01

    Objective The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis. Methods From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received an aortic advantage valve prosthesis. Complete cumulative follow‐up was 242.7 patient‐years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography. Results 30 day mortality was 2.4% (n = 4). Kaplan–Meier estimates of freedom from complications and linearised rates were as follows: 96.9 (1.6)% survival; 94.7 (1.3)% (2.06 patients/year) thrombo‐embolism; 99.4 (0.6)% (0.4 patients/year) bleeding; 98.8 (0.9)% (0.8 patients/year) non‐structural valve dysfunction; 98.8 (0.9)% (0.8 patients/year) reoperation. Valvular mean pressure gradients ranged from 16 (3) mm Hg for size 19 to 7 (2) mm Hg for size 27 and the corresponding effective orifice areas ranged from 1.2 (0.25) to 3.2 (0.66) cm2. In all, left ventricular mass significantly decreased (p<0.001) and fractional shortening increased (p<0.001) from postoperative to 1 year echocardiography. Conclusions Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use. PMID:17065186

  11. Revisiting the impacts of non-random extinction on the tree-of-life.

    PubMed

    Davies, T Jonathan; Yessoufou, Kowiyou

    2013-08-23

    The tree-of-life represents the diversity of living organisms. Species extinction and the concomitant loss of branches from the tree-of-life is therefore a major conservation concern. There is increasing evidence indicating that extinction is phylogenetically non-random, such that if one species is vulnerable to extinction so too are its close relatives. However, the impact of non-random extinctions on the tree-of-life has been a matter of recent debate. Here, we combine simulations with empirical data on extinction risk in mammals. We demonstrate that phylogenetically clustered extinction leads to a disproportionate loss of branches from the tree-of-life, but that the loss of their summed lengths is indistinguishable from random extinction. We argue that under a speciational model of evolution, the number of branches lost might be of equal or greater consequences than the loss of summed branch lengths. We therefore suggest that the impact of non-random extinction on the tree-of-life may have been underestimated.

  12. Clinical outcomes and kinetics of propanil following acute self-poisoning: a prospective case series

    PubMed Central

    Roberts, Darren M; Heilmair, Renate; Buckley, Nick A; Dawson, Andrew H; Fahim, Mohamed; Eddleston, Michael; Eyer, Peter

    2009-01-01

    Background Propanil is an important cause of death from acute pesticide poisoning, of which methaemoglobinaemia is an important manifestation. However, there is limited information about the clinical toxicity and kinetics. The objective of this study is to describe the clinical outcomes and kinetics of propanil following acute intentional self-poisoning. Methods 431 patients with a history of propanil poisoning were admitted from 2002 until 2007 in a large, multi-centre prospective cohort study in rural hospitals in Sri Lanka. 40 of these patients ingested propanil with at least one other poison and were not considered further. The remaining 391 patients were classified using a simple grading system on the basis of clinical outcomes; methaemoglobinaemia could not be quantified due to limited resources. Blood samples were obtained on admission and a subset of patients provided multiple samples for kinetic analysis of propanil and the metabolite 3,4-dichloroaniline (DCA). Results There were 42 deaths (median time to death 1.5 days) giving a case fatality of 10.7%. Death occurred despite treatment in the context of cyanosis, sedation, hypotension and severe lactic acidosis consistent with methaemoglobinaemia. Treatment consisted primarily of methylene blue (1 mg/kg for one or two doses), exchange transfusion and supportive care when methaemoglobinaemia was diagnosed clinically. Admission plasma concentrations of propanil and DCA reflected the clinical outcome. The elimination half-life of propanil was 3.2 hours (95% confidence interval 2.6 to 4.1 hours) and the concentration of DCA was generally higher, more persistent and more variable than propanil. Conclusion Propanil is the most lethal herbicide in Sri Lanka after paraquat. Methylene blue was largely prescribed in low doses and administered as intermittent boluses which are expected to be suboptimal given the kinetics of methylene blue, propanil and the DCA metabolite. But in the absence of controlled studies the

  13. Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

    PubMed Central

    Rahbar, Mohammad H.; Fox, Erin E.; del Junco, Deborah J.; Cotton, Bryan A.; Podbielski, Jeanette M.; Matijevic, Nena; Cohen, Mitchell J.; Schreiber, Martin A.; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah; Reynolds, Robert J.; Benjamin-Garner, Ruby; Holcomb, John B.

    2011-01-01

    Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. PMID:22001613

  14. Proton Therapy for Breast Cancer After Mastectomy: Early Outcomes of a Prospective Clinical Trial

    SciTech Connect

    MacDonald, Shannon M.; Patel, Sagar A.; Hickey, Shea; Specht, Michelle; Isakoff, Steven J.; Gadd, Michele; Smith, Barbara L.; Yeap, Beow Y.; Adams, Judith; DeLaney, Thomas F.; Kooy, Hanne; Lu, Hsiao-Ming; Taghian, Alphonse G.

    2013-07-01

    Purpose: Dosimetric planning studies have described potential benefits for the use of proton radiation therapy (RT) for locally advanced breast cancer. We report acute toxicities and feasibility of proton delivery for 12 women treated with postmastectomy proton radiation with or without reconstruction. Methods and Materials: Twelve patients were enrolled in an institutional review board-approved prospective clinical trial. The patients were assessed for skin toxicity, fatigue, and radiation pneumonitis during treatment and at 4 and 8 weeks after the completion of therapy. All patients consented to have photographs taken for documentation of skin toxicity. Results: Eleven of 12 patients had left-sided breast cancer. One patient was treated for right-sided breast cancer with bilateral implants. Five women had permanent implants at the time of RT, and 7 did not have immediate reconstruction. All patients completed proton RT to a dose of 50.4 Gy (relative biological effectiveness [RBE]) to the chest wall and 45 to 50.4 Gy (RBE) to the regional lymphatics. No photon or electron component was used. The maximum skin toxicity during radiation was grade 2, according to the Common Terminology Criteria for Adverse Events (CTCAE). The maximum CTCAE fatigue was grade 3. There have been no cases of RT pneumonitis to date. Conclusions: Proton RT for postmastectomy RT is feasible and well tolerated. This treatment may be warranted for selected patients with unfavorable cardiac anatomy, immediate reconstruction, or both that otherwise limits optimal RT delivery using standard methods.

  15. Bayesian probability analysis: a prospective demonstration of its clinical utility in diagnosing coronary disease

    SciTech Connect

    Detrano, R.; Yiannikas, J.; Salcedo, E.E.; Rincon, G.; Go, R.T.; Williams, G.; Leatherman, J.

    1984-03-01

    One hundred fifty-four patients referred for coronary arteriography were prospectively studied with stress electrocardiography, stress thallium scintigraphy, cine fluoroscopy (for coronary calcifications), and coronary angiography. Pretest probabilities of coronary disease were determined based on age, sex, and type of chest pain. These and pooled literature values for the conditional probabilities of test results based on disease state were used in Bayes theorem to calculate posttest probabilities of disease. The results of the three noninvasive tests were compared for statistical independence, a necessary condition for their simultaneous use in Bayes theorem. The test results were found to demonstrate pairwise independence in patients with and those without disease. Some dependencies that were observed between the test results and the clinical variables of age and sex were not sufficient to invalidate application of the theorem. Sixty-eight of the study patients had at least one major coronary artery obstruction of greater than 50%. When these patients were divided into low-, intermediate-, and high-probability subgroups according to their pretest probabilities, noninvasive test results analyzed by Bayesian probability analysis appropriately advanced 17 of them by at least one probability subgroup while only seven were moved backward. Of the 76 patients without disease, 34 were appropriately moved into a lower probability subgroup while 10 were incorrectly moved up. We conclude that posttest probabilities calculated from Bayes theorem more accurately classified patients with and without disease than did pretest probabilities, thus demonstrating the utility of the theorem in this application.

  16. Analgesic effect of magnesium in post-tonsillectomy patients: a prospective randomised clinical trial.

    PubMed

    Tugrul, S; Degirmenci, N; Eren, S B; Dogan, R; Veyseller, B; Ozturan, O

    2015-09-01

    The aim of this study was to assess the analgesic, bleeding and nausea/vomiting effects of magnesium with and without metamizol on post-tonsillectomy patients. This prospective and randomised clinical trial included 54 patients aged 18-63 years who were scheduled for elective tonsillectomy. The patients were randomly divided into two groups and administered either magnesium with metamizol or only metamizol. They had been classified as physical status class I and II using the American Society of Anesthesiologists guidelines. All patients underwent the same surgical procedure performed by a single surgeon. The groups did not differ according to age, sex, or duration of anaesthesia or surgery. Postoperative pain, bleeding and nausea/vomiting were evaluated using the VAS and bleeding and nausea/vomiting scores on the first, fifth and tenth days. On the first, fifth and tenth postoperative days, the VAS scores of the magnesium with metamizol group were significantly lower than those of the metamizol-only group (p1 = 0.001; p5 = 0.015; p10 = 0.015). There were no significant differences in postoperative bleeding and nausea/vomiting scores between the two groups (p = 0.425 and p = 0.258, respectively). This study showed that magnesium enhanced the analgesic effect on post-tonsillectomy pain. Use of magnesium with an analgesic drug may be beneficial for management of post-tonsillectomy pain.

  17. Translating Ocular Biomechanics into Clinical Practice: Current State and Future Prospects

    PubMed Central

    Girard, Michaël J.A.; Dupps, William J.; Baskaran, Mani; Scarcelli, Giuliano; Yun, Seok H.; Quigley, Harry A.; Sigal, Ian A.; Strouthidis, Nicholas G.

    2014-01-01

    Biomechanics – the study of the relationship between forces and function in living organisms – is thought to play a critical role in a significant number of ophthalmic disorders. This is not surprising, as the eye is a pressure vessel that requires a delicate balance of forces to maintain its homeostasis. Over the past few decades, basic science research in ophthalmology mostly confirmed that ocular biomechanics could explain in part the mechanisms involved in almost all major ophthalmic disorders such as optic nerve head neuropathies, angle closure, ametropia, presbyopia, cataract, corneal pathologies, retinal detachment, and macular degeneration. Translational biomechanics in ophthalmology, however, is still in its infancy. It is believed that its use could make significant advances in diagnosis and treatment. Several translational biomechanics strategies are already emerging, such as corneal stiffening for the treatment of keratoconus, and more are likely to follow. This review aims to cultivate the idea that biomechanics plays a major role in ophthalmology and that its clinical translation, lead by collaborative teams of clinicians and biomedical engineers, will benefit our patients. Specifically, recent advances and future prospects in corneal, iris, trabecular meshwork, crystalline lens, scleral and lamina cribrosa biomechanics are discussed. PMID:24832392

  18. Clinical and microarray analysis of breast cancers of all subtypes from two prospective preoperative chemotherapy studies

    PubMed Central

    Okuma, H S; Koizumi, F; Hirakawa, A; Nakatochi, M; Komori, O; Hashimoto, J; Kodaira, M; Yunokawa, M; Yamamoto, H; Yonemori, K; Shimizu, C; Fujiwara, Y; Tamura, K

    2016-01-01

    Background: We aimed to analyse clinical and gene expression profiles to predict pathologic complete response and disease-free survival using two consecutive, prospective, preoperative chemotherapy trial cohorts. Methods: Clinicopathological and gene expression data were evaluated in a cohort from two consecutive phase II preoperative studies that included patients with stage IIA–IIIC breast cancer of all subtypes. Analysed specimens were obtained before preoperative chemotherapy, and cDNA microarray analyses were performed using the Affymetrix Gene Chip U133 plus 2.0. Results: Between December 2005 and December 2010, 122 patients were analysed. The pathologic complete response rate was significantly higher in HER2+ and HR−/HER2− cancers. Age, pathologic complete response, HR−/HER2− status, and lymph node positivity (⩾4) were significant poor prognostic factors for disease-free survival. For the cDNA microarray analyses, sufficient tumour samples were available from 78 of the 107 patients (73%). An 8-gene signature predictive of pathologic complete response and a 17-gene signature predictive of prognosis were identified. Patients were categorised into low-risk (n=45) and high-risk groups (n=33) (HR 70.0, P=0.004). Conclusions: This study yielded preliminary data on the expression of specific genes predicting pathologic complete response and disease-free survival in a cohort of chemonaïve breast cancer patients. Further validation may distinguish those who would benefit most from perioperative chemotherapy as well as those needing further intervention. PMID:27415010

  19. Chemoprevention of Lung Cancer: Prospects and Disappointments in Human Clinical Trials

    PubMed Central

    Greenberg, Alissa K.; Tsay, Jun-Chieh; Tchou-Wong, Kam-Meng; Jorgensen, Anna; Rom, William N.

    2013-01-01

    Decreasing the risk of lung cancer, or preventing its development in high-risk individuals, would have a huge impact on public health. The most effective means to decrease lung cancer incidence is to eliminate exposure to carcinogens. However, with recent advances in the understanding of pulmonary carcinogenesis and the identification of intermediate biomarkers, the prospects for the field of chemoprevention research have improved dramatically. Here we review the most recent research in lung cancer chemoprevention—focusing on those agents that have been investigated in human clinical trials. These agents fall into three major categories. First, oxidative stress plays an important role in pulmonary carcinogenesis; and therefore, antioxidants (including vitamins, selenium, green tea extracts, and isothiocyanates) may be particularly effective in preventing the development of lung cancer. Second, inflammation is increasingly accepted as a crucial factor in carcinogenesis, and many investigators have focused on anti-inflammatory agents, such as glucocorticoids, NSAIDs, statins, and PPARγ agonists. Finally, the PI3K/AKT/mTOR pathway is recognized to play a central role in tobacco-induced carcinogenesis, and inhibitors of this pathway, including myoinositol and metformin, are promising agents for lung cancer prevention. Successful chemoprevention will likely require targeting of multiple pathways to carcinogenesis—both to minimize toxicity and maximize efficacy. PMID:24216701

  20. Clinical Outcomes and Microbiological Characteristics of Severe Pneumonia in Cancer Patients: A Prospective Cohort Study

    PubMed Central

    Rabello, Ligia S. C. F.; Silva, Jose R. L.; Azevedo, Luciano C. P.; Souza, Ivens; Torres, Viviane B. L.; Rosolem, Maíra M.; Lisboa, Thiago; Soares, Marcio; Salluh, Jorge I. F.

    2015-01-01

    Introduction Pneumonia is the most frequent type of infection in cancer patients and a frequent cause of ICU admission. The primary aims of this study were to describe the clinical and microbiological characteristics and outcomes in critically ill cancer patients with severe pneumonia. Methods Prospective cohort study in 325 adult cancer patients admitted to three ICUs with severe pneumonia not acquired in the hospital setting. Demographic, clinical and microbiological data were collected. Results There were 229 (71%) patients with solid tumors and 96 (29%) patients with hematological malignancies. 75% of all patients were in septic shock and 81% needed invasive mechanical ventilation. ICU and hospital mortality rates were 45.8% and 64.9%. Microbiological confirmation was present in 169 (52%) with a predominance of Gram negative bacteria [99 (58.6%)]. The most frequent pathogens were methicillin-sensitive S. aureus [42 (24.9%)], P. aeruginosa [41(24.3%)] and S. pneumonia [21 (12.4%)]. A relatively low incidence of MR [23 (13.6%)] was observed. Adequate antibiotics were prescribed for most patients [136 (80.5%)]. In multivariate analysis, septic shock at ICU admission [OR 5.52 (1.92–15.84)], the use of invasive MV [OR 12.74 (3.60–45.07)] and poor Performance Status [OR 3.00 (1.07–8.42)] were associated with increased hospital mortality. Conclusions Severe pneumonia is associated with high mortality rates in cancer patients. A relatively low rate of MR pathogens is observed and severity of illness and organ dysfunction seems to be the best predictors of outcome in this population. PMID:25803690

  1. The Clinical Course of Cirrhosis Patients Hospitalized for Acute Hepatic Deterioration: A Prospective Bicentric Study.

    PubMed

    Shi, Yu; Yan, Huadong; Zhou, Zhibo; Fang, Hong; Li, Jiawei; Ye, Honghua; Sun, Wenjie; Zhou, Wenhong; Ye, Jingfen; Yang, Qiao; Yang, Ying; Hu, Yaoren; Chen, Zhi; Sheng, Jifang

    2015-11-01

    Patients with cirrhosis are vulnerable to acute hepatic insults and are more likely to develop rapid hepatic deterioration. The aim of this study is to describe the clinical course of patients with cirrhosis and hospitalized for acute hepatic deterioration (AHD).This is a prospective study involving 163 patients with cirrhosis and AHD. The occurrence of organ failures, systemic inflammatory response syndrome (SIRS), and infections during hospital stay were recorded and the relationship between organ failure and death or SIRS/infection was subsequently analyzed.Of 163 patients, 35 did not develop any organ failure during in-hospital follow-ups (90-day mortality: 0%); 84 had intrahepatic organ failures (IH-OFs, defined by liver and/or coagulation failure) (90-day mortality: 22.0%); and 44 patients developed extra-hepatic organ failures (EH-OFs, defined by kidney, cerebral, circulation, and respiratory failure) on the basis of IH-OF with a 90-day mortality of 90.9%. On multivariable analysis by a Cox proportion hazard model, age, WBC, presence of IH-OF, and EH-OF all predicted 90-day death. A logistic regression analysis identified SIRS being associated with the development of EH-OF. Furthermore, IH-OF at admission and infections occurred during the hospital stay were shown to be another 2 potential risk factors.The clinical course of cirrhosis patients with acute hepatic injury was characterized by 3 consecutive stages (AHD, IH-OF, and EH-OF), which provided a clear risk stratification. The PIRO criteria provided an accurate frame for prognostication of those patients. The systemic inflammatory response syndrome may be a target for blocking the progression to the EH-OF stage.

  2. Hyperbaric Oxygen Therapy Can Diminish Fibromyalgia Syndrome – Prospective Clinical Trial

    PubMed Central

    Efrati, Shai; Golan, Haim; Bechor, Yair; Faran, Yifat; Daphna-Tekoah, Shir; Sekler, Gal; Fishlev, Gregori; Ablin, Jacob N.; Bergan, Jacob; Volkov, Olga; Friedman, Mony; Ben-Jacob, Eshel; Buskila, Dan

    2015-01-01

    Background Fibromyalgia Syndrome (FMS) is a persistent and debilitating disorder estimated to impair the quality of life of 2–4% of the population, with 9:1 female-to-male incidence ratio. FMS is an important representative example of central nervous system sensitization and is associated with abnormal brain activity. Key symptoms include chronic widespread pain, allodynia and diffuse tenderness, along with fatigue and sleep disturbance. The syndrome is still elusive and refractory. The goal of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT) on symptoms and brain activity in FMS. Methods and Findings A prospective, active control, crossover clinical trial. Patients were randomly assigned to treated and crossover groups: The treated group patients were evaluated at baseline and after HBOT. Patients in the crossover-control group were evaluated three times: baseline, after a control period of no treatment, and after HBOT. Evaluations consisted of physical examination, including tender point count and pain threshold, extensive evaluation of quality of life, and single photon emission computed tomography (SPECT) imaging for evaluation of brain activity. The HBOT protocol comprised 40 sessions, 5 days/week, 90 minutes, 100% oxygen at 2ATA. Sixty female patients were included, aged 21–67 years and diagnosed with FMS at least 2 years earlier. HBOT in both groups led to significant amelioration of all FMS symptoms, with significant improvement in life quality. Analysis of SPECT imaging revealed rectification of the abnormal brain activity: decrease of the hyperactivity mainly in the posterior region and elevation of the reduced activity mainly in frontal areas. No improvement in any of the parameters was observed following the control period. Conclusions The study provides evidence that HBOT can improve the symptoms and life quality of FMS patients. Moreover, it shows that HBOT can induce neuroplasticity and significantly rectify abnormal

  3. Sexual Function After Stereotactic Body Radiotherapy for Prostate Cancer: Results of a Prospective Clinical Trial

    SciTech Connect

    Wiegner, Ellen A.; King, Christopher R.

    2010-10-01

    Purpose: To study the sexual quality of life for prostate cancer patients after stereotactic body radiotherapy (SBRT). Methods and Materials: Using the Expanded Prostate Cancer Index Composite (EPIC)-validated quality-of-life questionnaire, the sexual function of 32 consecutive patients who received prostate SBRT in a prospective Phase II clinical trial were analyzed at baseline, and at median times of 4, 12, 20, and 50 months after treatment. SBRT consisted of 36.25 Gy in five fractions of 7.25 Gy using the Cyberknife. No androgen deprivation therapy was given. The use of erectile dysfunction (ED) medications was monitored. A comprehensive literature review for radiotherapy-alone modalities based on patient self-reported questionnaires served as historical comparison. Results: Median age at treatment was 67.5 years, and median follow-up was 35.5 months (minimum 12 months). The mean EPIC sexual domain summary score, sexual function score, and sexual bother score decreased by 45%, 49%, and 25% respectively at 50 months follow-up. These differences reached clinical relevance by 20 months after treatment. Baseline ED rate was 38% and increased to 71% after treatment (p = 0.024). Use of ED medications was 3% at baseline and progressed to 25%. For patients aged <70 years at follow-up, 60% maintained satisfactory erectile function after treatment compared with only 12% aged {>=}70 years (p = 0.008). Penile bulb dose was not associated with ED. Conclusions: The rates of ED after treatment appear comparable to those reported for other modalities of radiotherapy. Given the modest size of this study and the uncertainties in the physiology of radiotherapy-related ED, these results merit further investigations.

  4. Prospective memory on a novel clinical task in older adults with mild cognitive impairment and subjective cognitive decline

    PubMed Central

    Rabin, Laura A.; Chi, Susan Y.; Wang, Cuiling; Fogel, Joshua; Kann, Sarah J.; Aronov, Avner

    2014-01-01

    Despite the relevance of prospective memory to everyday functioning and the ability to live independently, prospective memory tasks are rarely incorporated into clinical evaluations of older adults. We investigated the validity and clinical utility of a recently developed measure, the Royal Prince Alfred Prospective Memory Test (RPA-ProMem), in a demographically diverse, non-demented, community-dwelling sample of 257 older adults (mean age = 80.78 years, 67.7% female) with amnestic mild cognitive impairment (aMCI, n = 18), non-amestic mild cognitive impairment (naMCI, n = 38), subjective cognitive decline (SCD, n = 83) despite intact performance on traditional episodic memory tests, and healthy controls (HC, n = 118). Those with aMCI and naMCI performed significantly worse than controls on the RPA-ProMem and its subtasks (time-based, event-based, short-term, long-term). Also, those with SCD scored significantly lower than controls on long-term, more naturalistic subtasks. Additional results supported the validity and inter-rater reliability of the RPA-ProMem and demonstrated a relation between test scores and informant reports of real-world functioning. The RPA-ProMem may help detect subtle cognitive changes manifested by individuals in the earliest stages of dementia, which may be difficult to capture with traditional episodic memory tests. Also, assessment of prospective memory can help guide the development of cognitive interventions for older adults at risk for dementia. PMID:24875614

  5. Prediction of manifest Huntington disease with clinical and imaging measures: A 12-year prospective observational study

    PubMed Central

    Paulsen, Jane S.; Long, Jeffrey D.; Ross, Christopher A.; Harrington, Deborah L.; Erwin, Cheryl J.; Williams, Janet K.; Westervelt, Holly James; Johnson, Hans J.; Aylward, Elizabeth H.; Zhang, Ying; Bockholt, H. Jeremy; Barker, Roger A.

    2015-01-01

    BACKGROUND Although correlation between cytosine-adenine-guanine (CAG) repeat length and age of Huntington disease (HD) onset is well known, improved prediction of onset would be advantageous for clinical trial design and prognostic counseling. We compared genetic, demographic, motor, cognitive, psychiatric, functional and imaging measures for tracking progression and predicting conversion to manifest HD. METHODS N=1078 research participants with the gene mutation for HD, but without a rating of 4 on the Diagnostic Confidence Level (DCL) following administration of the 15-item motor assessment of the Unified Huntington’s Disease Rating Scale. Participants were from 33 world wide sites and followed for up to 12 years (mean=5, SD=3·3) over the period 2001–2013. A subset of 225 participants prospectively converted to manifest HD according to the DCL (“meets the operational definition of the unequivocal presence of an otherwise unexplained extrapyramidal movement disorder in a subject at risk for HD” with ≥99% confidence). Joint modeling of longitudinal and survival data was used to examine the extent to which baseline and change of 40 variables analyzed separately was predictive of CAG-adjusted age at motor diagnosis. FINDINGS Cross-sectional and longitudinal clinical and imaging measures were significant predictors of motor diagnosis beyond CAG repeat length and age. The strongest predictors in the top three phenotypic domains were total motor score (motor), putamen volume (imaging), and Stroop word test (cognitive). A one standard deviation (SD) difference in total motor score increased the risk of a motor diagnosis by 3·1 times (95% CI=[2·3,4·2]), one SD loss in putamen volume increased risk by 3·3 times ([2·4,4·7]) and one SD cognitive decline increased risk by 2·3 ([1·9,2·9]). INTERPRETATION Prediction of HD diagnosis can be considerably improved beyond that obtained by CAG repeat length and age alone. Such knowledge about potential predictors

  6. Regulatory Considerations Of Waste Emplacement Within The WIPP Repository: Random Versus Non-Random Distribution

    SciTech Connect

    Casey, S. C.; Patterson, R. L.; Gross, M.; Lickliter, K.; Stein, J. S.

    2003-02-25

    The U.S. Department of Energy (DOE) is responsible for disposing of transuranic waste in the Waste Isolation Pilot Plant (WIPP) in southeastern New Mexico. As part of that responsibility, DOE must comply with the U.S. Environmental Protection Agency's (EPA) radiation protection standards in Title 40 Code of Federal Regulations (CFR), Parts 191 and 194. This paper addresses compliance with the criteria of 40 CFR Section 194.24(d) and 194.24(f) that require DOE to either provide a waste loading scheme for the WIPP repository or to assume random emplacement in the mandated performance and compliance assessments. The DOE established a position on waste loading schemes during the process of obtaining the EPA's initial Certification in 1998. The justification for utilizing a random waste emplacement distribution within the WIPP repository was provided to the EPA. During the EPA rulemaking process for the initial certification, the EPA questioned DOE on whether waste would be loaded randomly as modeled in long-term performance assessment (PA) and the impact, if any, of nonrandom loading. In response, DOE conducted an impact assessment for non-random waste loading. The results of this assessment supported the contention that it does not matter whether random or non-random waste loading is assumed for the PA. The EPA determined that a waste loading plan was unnecessary because DOE had assumed random waste loading and evaluated the potential consequences of non-random loading for a very high activity waste stream. In other words, the EPA determined that DOE was not required to provide a waste loading scheme because compliance is not affected by the actual distribution of waste containers in the WIPP.

  7. An open label, prospective, clinical study on a polyherbal formulation in osteoarthritis of knee

    PubMed Central

    Nipanikar, Sanjay U.; Saluja, Manjit; Kuber, Vinod V.; Kadbhane, Kalyan P.; Chopra, Arvind; Khade, Namdev R.

    2013-01-01

    Background: Currently, though pharmacological, mechanical, and surgical interventions are used, there is no known cure for osteoarthritis (OA). Objectives: The main aim of the study was to assess the efficacy and safety of “TLPL/AY/03/2008”, a polyherbal formulation on knee joint pain assessed on visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Materials and Methods: It was an open label, single center, prospective, clinical study conducted in 36 patients of OA Knee. Two capsules of ‘TLPL/AY/03/2008’ were given to all patients twice daily orally after meals for 180 days. Results: Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. The mean joint pain (as assessed on VAS) reduced significantly (59.85%; P < 0.05) and the mean WOMAC combined score, WOMAC pain sub-score, WOMAC stiffness sub-score, and WOMAC difficulty sub-score also reduced significantly at the end of the study. The mean time taken by the patients to walk 50 feet too, was reduced significantly (25.26%) at the end of the study. At the end of 4 months of the treatment, no patient needed paracetamol as rescue medicine to control pain. Most of the patients had shown good overall improvement assessed by the physician and by the patients. Majority of the patients showed excellent tolerability to the study drug. No significant change in most of the safety laboratory parameters was observed at the end of the study. Conclusion: The study provides good evidence in support of the efficacy and safety of the ‘TLPL/AY/03/2008’ in OA of knee. PMID:23741160

  8. Coblation vs. Electrocautery Tonsillectomy: A Prospective Randomized Study Comparing Clinical Outcomes in Adolescents and Adults

    PubMed Central

    Hong, Sung-Moon; Cho, Jae-Gu; Chae, Sung Won; Lee, Heung-Man

    2013-01-01

    Objectives Coblation is operated in low temperature, so it is proposed that tonsillectomy with coblation involves less postoperative pain and allows accelerated healing of the tonsillar fossae compared with other methods involving heat driven processes. However, the results of the previous studies showed that the effect of coblation tonsillectomy has been equivocal in terms of postoperative pain and hemorrhage. Though, most of the previous studies which evaluated coblation tonsillectomy were performed in children. Recently, electrocautery tonsillectomy has been used most widely because of the reduced intraoperative blood loss and shorter operative time compared to other techniques. This prospective study compared intraoperative records and postoperative clinical outcomes in adolescents and adults following coblation and electrocautery tonsillectomies. Methods Eighty patients over 16 years of age with histories of recurrent tonsillitis were enrolled. The patients were randomly allocated into coblation (n=40) and electrocautery tonsillectomy groups (n=40). All operations were performed by one surgeon who was skilled in both surgical techniques. Intraoperative parameters and postoperative outcomes were checked. Results Postoperative pain and otalgia were not significantly different between the two groups; however, there was a tendency towards reduced pain and otalgia in the coblation group. More cotton balls for swabbing the operative field were used introoperatively in the electrocautery group (P=0.00). There was no significant difference in postoperative hemorrhage, wound healing, commencement of a regular diet, and foreign body sensation between the groups. Conclusion Only cotton use, which represented the amount of blood loss, was less in the coblation tonsillectomy group. Coblation tonsillectomy warrants further study with respect to the decreased postoperative pain and otalgia. PMID:23799166

  9. Risk factors associated with exertional medial tibial pain: a 12 month prospective clinical study

    PubMed Central

    Burne, S; Khan, K; Boudville, P; Mallet, R; Newman, P; Steinman, L; Thornton, E

    2004-01-01

    Objective: To investigate in a military setting the potential role of intrinsic biomechanical and anthropometric risk factors for, and the incidence of, exertional medial tibial pain (EMTP). Methods: A prospective clinical outcome study in a cohort of 122 men and 36 women at the Australian Defence Force Academy. Each cadet underwent measurements of seven intrinsic variables: hip range of motion, leg length discrepancy, lean calf girth, maximum ankle dorsiflexion range, foot type, rear foot alignment, and tibial alignment. Test–retest reliability was undertaken on each variable. A physician recorded any cadet presenting with diagnostic criteria of EMTP. Records were analysed at 12 months for EMTP presentation and for military fitness test results. Results: 23 cadets (12 men, 11 women) met the criteria for EMTP after 12 months, with a cross gender (F/M) odds ratio of 3.1. In men, both internal and external range of hip motion was greater in those with EMTP: left internal (12°, p = 0.000), right internal (8°, p = 0.014), left external (8°, p = 0.042), right external (9°, p = 0.026). Lean calf girth was lower by 4.2% for the right leg (p = 0.040) but by only 2.9% for the left leg (p = 0.141). No intrinsic risk factor was associated with EMTP in women. EMTP was the major cause for non-completion of the run component of the ADFA fitness test in both men and women. Conclusions: Greater internal and external hip range of motion and lower lean calf girth were associated with EMTP in male military cadets. Women had high rates of injury, although no intrinsic factor was identified. Reasons for this sex difference need to be identified. PMID:15273181

  10. A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation

    PubMed Central

    Kasiske, Bertram L.; Nashan, Bjorn; Del Carmen Rial, Maria; Raffaele, Pablo; Russ, Graeme; Campistol, Josep; Pescovitz, Mark D.; Keown, Paul A.

    2012-01-01

    This prospective pharmacoepidemiological study examined treatment and outcomes in patients converted to sirolimus (SRL) after renal transplantation. 484 subjects in 36 centres in 7 countries were followed for up to 5 years. Principal reasons for conversion were declining graft function (146/484, 30%) and side effects of prior therapy (144/484, 30%) and the major treatment combinations after conversion were SRL ± MMF (62%), SRL + TAC (21.5%), SRL + CSA (16.5%). The cumulative probability of biopsy-confirmed acute rejection (BCAR) was 5% (n = 22), death-censored graft loss 12% (n = 56) and death 6% (n = 22), and there was no significant relationship to the treatment combination employed. Median calculated creatinine clearance was 48.4 (29.3, 64.5) mL/min at conversion, rising to 54.1 (41.2, 69.0) mL/min at month 1, 55.7 (39.0, 73.0) mL/min at month 12, 58.6 (39.7, 75.2) mL/min at two years and 60.9 (36.0, 77.0) mL/min at three years post-conversion. The most common adverse events were hypertension (47%), hyperlipidemia (26%), urinary tract infections (25%), anaemia (24%) and diarrhea (14%), and cardiac events, hyperlipemia and CMV infection were more common in patients converted during the first year. SRL was most frequently combined with MMF after conversion, but principal clinical outcomes were not significantly influenced by the treatment combination employed in normal practice. PMID:22934151

  11. Clinical and echocardiographic characteristics of papillary fibroelastomas: a retrospective and prospective study in 162 patients

    NASA Technical Reports Server (NTRS)

    Sun, J. P.; Asher, C. R.; Yang, X. S.; Cheng, G. G.; Scalia, G. M.; Massed, A. G.; Griffin, B. P.; Ratliff, N. B.; Stewart, W. J.; Thomas, J. D.

    2001-01-01

    BACKGROUND: Cardiac papillary fibroelastoma (CPF) is a primary cardiac neoplasm that is increasingly detected by echocardiography. The clinical manifestations of this entity are not well described. METHODS AND RESULTS: In a 16-year period, we identified patients with CPF from our pathology and echocardiography databases. A total of 162 patients had pathologically confirmed CPF. Echocardiography was performed in 141 patients with 158 CPFs, and 48 patients had CPFs that were not visible by echocardiography (<0.2 cm), leaving an echocardiographic subgroup of 93 patients with 110 CPFs. An additional 45 patients with a presumed diagnosis of CPF were identified. The mean age of the patients was 60+/-16 years of age, and 46.1% were male. Echocardiographically, the mean size of the CPFs was 9+/-4.6 mm; 82.7% occurred on valves (aortic more than mitral), 43.6% were mobile, and 91.4% were single. During a follow-up period of 11+/-22 months, 23 of 26 patients with a prospective diagnosis of CPF that was confirmed by pathological examination had symptoms that could be attributable to embolization. In the group of 45 patients with a presumed diagnosis of CPF, 3 patients had symptoms that were likely due to embolization (incidence, 6.6%) during a follow-up period of 552+/-706 days. CONCLUSIONS: CPFs are generally small and single, occur most often on valvular surfaces, and may be mobile, resulting in embolization. Because of the potential for embolic events, symptomatic patients, patients undergoing cardiac surgery for other lesions, and those with highly mobile and large CPFs should be considered for surgical excision.

  12. Two-piece zirconia implants supporting all-ceramic crowns: A prospective clinical study

    PubMed Central

    Cionca, Norbert; Müller, Nada; Mombelli, Andrea

    2015-01-01

    Objectives The aim of this prospective clinical study is to evaluate the safety and efficacy of a new all-ceramic implant system to replace missing teeth in partially edentulous patients. Material and methods Thirty-two partially edentulous, systemically healthy patients were treated with 49 two-piece zirconia implants (ZERAMEX® T Implant System). Zirconia abutments were connected with adhesive resin cement. Single-unit full-ceramic crowns were cemented. The cases have been followed for 588±174 days after loading (range 369–889 days). All patients have been re-evaluated 1 year after loading. Results The cumulative survival rate 1 year after loading was 87% implants. All failures were the result of aseptic loosening, and no implants were lost after the first year. The results of the other cases were good, and the patients were very satisfied. The cumulative soft tissue complication rate was 0%, the cumulative technical complication rate was 4% implants, the cumulative complication rate for bone loss >2 mm was 0%, and the cumulative esthetic complication rate was 0%. Including the data from 20 patients treated with an earlier version of the system, an over-all 2-year cumulative survival rate of 86% was calculated for a total of 76 two-piece zirconia implants supporting all-ceramic crowns in 52 patients. Conclusions Replacement of single teeth in the posterior area was possible with this new full-ceramic implant system. Failures were due to aseptic loosening. PMID:24666352

  13. Stereotactic Body Radiotherapy for Localized Prostate Cancer: Interim Results of a Prospective Phase II Clinical Trial

    SciTech Connect

    King, Christopher R. Brooks, James D.; Gill, Harcharan; Pawlicki, Todd; Cotrutz, Cristian; Presti, Joseph C.

    2009-03-15

    Purpose: The radiobiology of prostate cancer favors a hypofractionated dose regimen. We report results of a prospective Phase II clinical trial of stereotactic body radiotherapy (SBRT) for localized prostate cancer. Methods and Materials: Forty-one low-risk prostate cancer patients with 6 months' minimum follow-up received 36.25 Gy in five fractions of 7.25 Gy with image-guided SBRT alone using the CyberKnife. The early (<3 months) and late (>6 months) urinary and rectal toxicities were assessed using validated quality of life questionnaires (International Prostate Symptom Score, Expanded Prostate Cancer Index Composite) and the Radiation Therapy Oncology Group (RTOG) toxicity criteria. Patterns of prostate-specific antigen (PSA) response are analyzed. Results: The median follow-up was 33 months. There were no RTOG Grade 4 acute or late rectal/urinary complications. There were 2 patients with RTOG Grade 3 late urinary toxicity and none with RTOG Grade 3 rectal complications. A reduced rate of severe rectal toxicities was observed with every-other-day vs. 5 consecutive days treatment regimen (0% vs. 38%, p = 0.0035). A benign PSA bounce (median, 0.4 ng/mL) was observed in 12 patients (29%) occurring at 18 months (median) after treatment. At last follow-up, no patient has had a PSA failure regardless of biochemical failure definition. Of 32 patients with 12 months minimum follow-up, 25 patients (78%) achieved a PSA nadir {<=}0.4 ng/mL. A PSA decline to progressively lower nadirs up to 3 years after treatment was observed. Conclusions: The early and late toxicity profile and PSA response for prostate SBRT are highly encouraging. Continued accrual and follow-up will be necessary to confirm durable biochemical control rates and low toxicity profiles.

  14. Early sedation and clinical outcomes of mechanically ventilated patients: a prospective multicenter cohort study

    PubMed Central

    2014-01-01

    Introduction Sedation overuse is frequent and possibly associated with poor outcomes in the intensive care unit (ICU) patients. However, the association of early oversedation with clinical outcomes has not been thoroughly evaluated. The aim of this study was to assess the association of early sedation strategies with outcomes of critically ill adult patients under mechanical ventilation (MV). Methods A secondary analysis of a multicenter prospective cohort conducted in 45 Brazilian ICUs, including adult patients requiring ventilatory support and sedation in the first 48 hours of ICU admissions, was performed. Sedation depth was evaluated after 48 hours of MV. Multivariate analysis was used to identify variables associated with hospital mortality. Results A total of 322 patients were evaluated. Overall, ICU and hospital mortality rates were 30.4% and 38.8%, respectively. Deep sedation was observed in 113 patients (35.1%). Longer duration of ventilatory support was observed (7 (4 to 10) versus 5 (3 to 9) days, P = 0.041) and more tracheostomies were performed in the deep sedation group (38.9% versus 22%, P = 0.001) despite similar PaO2/FiO2 ratios and acute respiratory distress syndrome (ARDS) severity. In a multivariate analysis, age (Odds Ratio (OR) 1.02; 95% confidence interval (CI) 1.00 to 1.03), Charlson Comorbidity Index >2 (OR 2.06; 95% CI, 1.44 to 2.94), Simplified Acute Physiology Score 3 (SAPS 3) score (OR 1.02; CI 95%, 1.00 to 1.04), severe ARDS (OR 1.44; CI 95%, 1.09 to 1.91) and deep sedation (OR 2.36; CI 95%, 1.31 to 4.25) were independently associated with increased hospital mortality. Conclusions Early deep sedation is associated with adverse outcomes and constitutes an independent predictor of hospital mortality in mechanically ventilated patients. PMID:25047960

  15. The Epidemiology and Clinical Spectrum of Melioidosis: 540 Cases from the 20 Year Darwin Prospective Study

    PubMed Central

    Currie, Bart J.; Ward, Linda; Cheng, Allen C.

    2010-01-01

    Background Over 20 years, from October 1989, the Darwin prospective melioidosis study has documented 540 cases from tropical Australia, providing new insights into epidemiology and the clinical spectrum. Principal Findings The principal presentation was pneumonia in 278 (51%), genitourinary infection in 76 (14%), skin infection in 68 (13%), bacteremia without evident focus in 59 (11%), septic arthritis/osteomyelitis in 20 (4%) and neurological melioidosis in 14 (3%). 298 (55%) were bacteremic and 116 (21%) developed septic shock (58 fatal). Internal organ abscesses and secondary foci in lungs and/or joints were common. Prostatic abscesses occurred in 76 (20% of 372 males). 96 (18%) had occupational exposure to Burkholderia pseudomallei. 118 (22%) had a specific recreational or occupational incident considered the likely infecting event. 436 (81%) presented during the monsoonal wet season. The higher proportion with pneumonia in December to February supports the hypothesis of infection by inhalation during severe weather events. Recurrent melioidosis occurred in 29, mostly attributed to poor adherence to therapy. Mortality decreased from 30% in the first 5 years to 9% in the last five years (p<0.001). Risk factors for melioidosis included diabetes (39%), hazardous alcohol use (39%), chronic lung disease (26%) and chronic renal disease (12%). There was no identifiable risk factor in 20%. Of the 77 fatal cases (14%), 75 had at least one risk factor; the other 2 were elderly. On multivariate analysis of risk factors, age, location and season, the only independent predictors of mortality were the presence of at least one risk factor (OR 9.4; 95% CI 2.3–39) and age ≥50 years (OR 2.0; 95% CI 1.2–2.3). Conclusions Melioidosis should be seen as an opportunistic infection that is unlikely to kill a healthy person, provided infection is diagnosed early and resources are available to provide appropriate antibiotics and critical care. PMID:21152057

  16. Toxoplasmic Retinochoroiditis: Clinical Characteristics and Visual Outcome in a Prospective Study

    PubMed Central

    Curi, André Luiz Land; Benchimol, Eliezer Israel; Amendoeira, Maria Regina Reis

    2016-01-01

    Purpose To ascertain the clinical features and visual outcome of toxoplasma retinochoroiditis in a large series of cases. Subjects and Methods Two hundred and thirty subjects diagnosed with active toxoplasma retinochoroiditis were prospectively followed for periods ranging from 269 to 1976 days. All patients presented with active retinochoroiditis and positive IgG T. gondii serology at the beginning of the study and received a standardized drug treatment for toxoplasmosis, both in the first episode and in the subsequent recurrences. Results The group involved 118 (51.3%) men and 112 (48.7%) women, with ages ranging from 14 to 77 years, mean of 32.4 years (SD = 11.38). Primary retinochoroidal lesions were observed in 52 (22.6%) cases and active retinochoroiditis combined with old scars in 178 (77.4%) subjects at the beginning of the study. A hundred sixty-two recurrent episodes in 104 (45.2%) patients were observed during follow-up. New subclinical retinochoroidal lesions were detected in 23 of 162 (14.2%) recurrences episodes during the follow-up. Posterior segment complications were observed in 73 (31.7%) subjects. Retinochoroidal lesions adjacent to the optic nerve and in the macular area were observed in 27 of 40 (67.5%) cases of severe visual impairment (VA = 20/200 or worse). Conclusion Toxoplasma retinochoroiditis in this population had a high recurrence rate after an active episode. Severe visual impairment was associated with location of the retinochoroidal scar, recurrences and posterior segment complications. It is crucial to consider the location of the lesion in studies analyzing visual prognosis as a measure for treatment effectiveness and prevention strategies. PMID:27136081

  17. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial.

    PubMed

    Steingrimsson, S; Thimour-Bergström, L; Roman-Emanuel, C; Scherstén, H; Friberg, Ö; Gudbjartsson, T; Jeppsson, A

    2015-12-01

    Surgical site infection is a common complication following cardiac surgery. Triclosan-coated sutures have been shown to reduce the rate of infections in various surgical wounds, including wounds after vein harvesting in coronary artery bypass grafting patients. Our purpose was to compare the rate of infections in sternotomy wounds closed with triclosan-coated or conventional sutures. A total of 357 patients that underwent coronary artery bypass grafting were included in a prospective randomized double-blind single-center study. The patients were randomized to closure of the sternal wound with either triclosan-coated sutures (Vicryl Plus and Monocryl Plus, Ethicon, Inc., Somerville, NJ, USA) (n = 179) or identical sutures without triclosan (n = 178). Patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). The primary endpoint was the prevalence of sternal wound infection according to the Centers for Disease Control and Prevention (CDC) criteria. The demographics in both groups were comparable, including age, gender, body mass index, and rate of diabetes and smoking. Sternal wound infection was diagnosed in 43 patients; 23 (12.8%) sutured with triclosan-coated sutures compared to 20 (11.2%) sutured without triclosan (p = 0.640). Most infections were superficial (n = 36, 10.1%), while 7 (2.0%) were deep sternal wound infections. There were 16 positive cultures in the triclosan group and 17 in the non-coated suture group (p = 0.842). The most commonly identified main pathogens were Staphylococcus aureus (45.4%) and coagulase-negative staphylococci (36.4%). Skin closure with triclosan-coated sutures did not reduce the rate of sternal wound infection after coronary artery bypass grafting. (clinicaltrials.gov: NCT01212315).

  18. Immune thrombocytopenia in adults: a prospective cohort study of clinical features and predictors of outcome

    PubMed Central

    Grimaldi-Bensouda, Lamiae; Nordon, Clémentine; Michel, Marc; Viallard, Jean-François; Adoue, Daniel; Magy-Bertrand, Nadine; Durand, Jean-Marc; Quittet, Philippe; Fain, Olivier; Bonnotte, Bernard; Morin, Anne-Sophie; Morel, Nathalie; Costedoat-Chalumeau, Nathalie; Pan-Petesch, Brigitte; Khellaf, Mehdi; Perlat, Antoinette; Sacre, Karim; Lefrere, François; Abenhaim, Lucien; Godeau, Bertrand

    2016-01-01

    This prospective observational cohort study aimed to explore the clinical features of incident immune thrombocytopenia in adults and predictors of outcome, while determining if a family history of autoimmune disorder is a risk factor for immune thrombocytopenia. All adults, 18 years of age or older, recently diagnosed with immune thrombocytopenia were consecutively recruited across 21 hospital centers in France. Data were collected at diagnosis and after 12 months. Predictors of chronicity at 12 months were explored using logistic regression models. The association between family history of autoimmune disorder and the risk of developing immune thrombocytopenia was explored using a conditional logistic regression model after matching each case to 10 controls. One hundred and forty-three patients were included: 63% female, mean age 48 years old (Standard Deviation=19), and 84% presented with bleeding symptoms. Median platelet count was 10×109/L. Initial treatment was required in 82% of patients. After 12 months, only 37% of patients not subject to disease-modifying interventions achieved cure. The sole possible predictor of chronicity at 12 months was a higher platelet count at baseline [Odds Ratio 1.03; 95%CI: 1.00, 1.06]. No association was found between outcome and any of the following features: age, sex, presence of either bleeding symptoms or antinuclear antibodies at diagnosis. Likewise, family history of autoimmune disorder was not associated with incident immune thrombocytopenia. Immune thrombocytopenia in adults has been shown to progress to a chronic form in the majority of patients. A lower platelet count could be indicative of a more favorable outcome. PMID:27229715

  19. Clinical deterioration in older adults with delirium during early hospitalisation: a prospective cohort study

    PubMed Central

    Hsieh, S Jean; Madahar, Purnema; Hope, Aluko A; Zapata, Jennifer; Gong, Michelle N

    2015-01-01

    Objectives To measure the prevalence and incidence of delirium in older adults as they transition from the emergency department (ED) to the inpatient ward, and to determine the association between delirium during early hospitalisation and subsequent clinical deterioration. Design Prospective cohort study. Setting Urban tertiary care hospital in Bronx, New York. Participants Adults aged 65 years or older admitted to the inpatient ward from the ED (n=260). Measurements Beginning in the ED, delirium was assessed daily for 3 days, using the Confusion Assessment Method for the Intensive Care Unit. Outcomes (1) Clinical deterioration, defined as unanticipated intensive care unit (ICU) admission or in-hospital death (primary outcome); (2) decline in discharge status, defined as discharge to higher level of care, hospice or in-hospital death. Results 38 of 260 participants (15%) were delirious at least once during the first 3 days of hospitalisation. Of the 29 (11%) patients with delirium in the ED (ie, hospital day 1), delirium persisted into hospital day 2 in 72% (n=21), and persisted for all 3 days in 52% (n=15). In multivariate analyses, as little as 1 episode of delirium during the first 3 days was associated with increased odds of unanticipated ICU admission or in-hospital death (adjusted OR 8.07 (95% CI 1.91 to 34.14); p=0.005). Delirium that persisted for all 3 days was associated with a decline in discharge status, even after adjusting for factors such as severity of illness and baseline cognitive impairment (adjusted OR 4.70 (95% CI 1.41 to 15.63); p=0.012). Conclusions Delirium during the first few days of hospitalisation was associated with poor outcomes in older adults admitted from the ED to the inpatient ward. These findings suggest the need for serial delirium monitoring that begins in the ED to identify a high-risk population that may benefit from closer follow-up and intervention. PMID:26353866

  20. Non-random biodiversity loss underlies predictable increases in viral disease prevalence.

    PubMed

    Lacroix, Christelle; Jolles, Anna; Seabloom, Eric W; Power, Alison G; Mitchell, Charles E; Borer, Elizabeth T

    2014-03-01

    Disease dilution (reduced disease prevalence with increasing biodiversity) has been described for many different pathogens. Although the mechanisms causing this phenomenon remain unclear, the disassembly of communities to predictable subsets of species, which can be caused by changing climate, land use or invasive species, underlies one important hypothesis. In this case, infection prevalence could reflect the competence of the remaining hosts. To test this hypothesis, we measured local host species abundance and prevalence of four generalist aphid-vectored pathogens (barley and cereal yellow dwarf viruses) in a ubiquitous annual grass host at 10 sites spanning 2000 km along the North American West Coast. In laboratory and field trials, we measured viral infection as well as aphid fecundity and feeding preference on several host species. Virus prevalence increased as local host richness declined. Community disassembly was non-random: ubiquitous hosts dominating species-poor assemblages were among the most competent for vector production and virus transmission. This suggests that non-random biodiversity loss led to increased virus prevalence. Because diversity loss is occurring globally in response to anthropogenic changes, such work can inform medical, agricultural and veterinary disease research by providing insights into the dynamics of pathogens nested within a complex web of environmental forces.

  1. Non-random mate choice in humans: insights from a genome scan.

    PubMed

    Laurent, R; Toupance, B; Chaix, R

    2012-02-01

    Little is known about the genetic factors influencing mate choice in humans. Still, there is evidence for non-random mate choice with respect to physical traits. In addition, some studies suggest that the Major Histocompatibility Complex may affect pair formation. Nowadays, the availability of high density genomic data sets gives the opportunity to scan the genome for signatures of non-random mate choice without prior assumptions on which genes may be involved, while taking into account socio-demographic factors. Here, we performed a genome scan to detect extreme patterns of similarity or dissimilarity among spouses throughout the genome in three populations of African, European American, and Mexican origins from the HapMap 3 database. Our analyses identified genes and biological functions that may affect pair formation in humans, including genes involved in skin appearance, morphogenesis, immunity and behaviour. We found little overlap between the three populations, suggesting that the biological functions potentially influencing mate choice are population specific, in other words are culturally driven. Moreover, whenever the same functional category of genes showed a significant signal in two populations, different genes were actually involved, which suggests the possibility of evolutionary convergences.

  2. Impact of non-random vibrations in Mössbauer rotor experiments testing time dilation

    NASA Astrophysics Data System (ADS)

    Friedman, Y.; Nowik, I.; Felner, I.; Steiner, J. M.; Yudkin, E.; Livshitz, S.; Wille, H.-C.; Wortmann, G.; Arogeti, S.; Levy, R.; Chumakov, A. I.; Rüffer, R.

    2016-06-01

    All experiments testing time dilation by measuring the spectral shift of a rotating Mössbauer absorber assume that vibrations do not affect the spectral shift because of their purely random nature and claim that the observed shift is due to time dilation only. Our recent experiment using the Synchrotron Mössbauer Source at ESRF revealed, however, a shift due to the non-random periodic vibration patterns caused by the rotor/bearing system. These patterns fit the predictions of the Jeffcott model for such a system with non-zero eccentricity. We have calculated this shift due to the non-random vibrations and the resulting relative shift between two states when the acceleration of the absorber is anti-parallel and parallel to the source. This relative shift exhibits the same behavior as the observed relative shift. Hence, the effect of the spectral shift due to vibrations cannot be ignored in any Mössbauer rotor experiments for testing time dilation. Recommendations for improvement of future rotor experiments testing time dilation are presented.

  3. Non-random biodiversity loss underlies predictable increases in viral disease prevalence.

    PubMed

    Lacroix, Christelle; Jolles, Anna; Seabloom, Eric W; Power, Alison G; Mitchell, Charles E; Borer, Elizabeth T

    2014-03-01

    Disease dilution (reduced disease prevalence with increasing biodiversity) has been described for many different pathogens. Although the mechanisms causing this phenomenon remain unclear, the disassembly of communities to predictable subsets of species, which can be caused by changing climate, land use or invasive species, underlies one important hypothesis. In this case, infection prevalence could reflect the competence of the remaining hosts. To test this hypothesis, we measured local host species abundance and prevalence of four generalist aphid-vectored pathogens (barley and cereal yellow dwarf viruses) in a ubiquitous annual grass host at 10 sites spanning 2000 km along the North American West Coast. In laboratory and field trials, we measured viral infection as well as aphid fecundity and feeding preference on several host species. Virus prevalence increased as local host richness declined. Community disassembly was non-random: ubiquitous hosts dominating species-poor assemblages were among the most competent for vector production and virus transmission. This suggests that non-random biodiversity loss led to increased virus prevalence. Because diversity loss is occurring globally in response to anthropogenic changes, such work can inform medical, agricultural and veterinary disease research by providing insights into the dynamics of pathogens nested within a complex web of environmental forces. PMID:24352672

  4. Organizational development trajectory of a large academic radiotherapy department set up similarly to a prospective clinical trial: the MAASTRO experience

    PubMed Central

    Boersma, L; Dekker, A; Hermanns, E; Houben, R; Govers, M; van Merode, F; Lambin, P

    2015-01-01

    Objective: To simultaneously improve patient care processes and clinical research activities by starting a hypothesis-driven reorganization trajectory mimicking the rigorous methodology of a prospective clinical trial. Methods: The design of this reorganization trajectory was based on the model of a prospective trial. It consisted of (1) listing problems and analysing their potential causes, (2) defining interventions, (3) defining end points and (4) measuring the effect of the interventions (i.e. at baseline and after 1 and 2 years). The primary end point for patient care was the number of organizational root causes of incidents/near incidents; for clinical research, it was the number of patients in trials. There were several secondary end points. We analysed the data using two sample z-tests, χ2 test, a Mann–Whitney U test and the one-way analysis of variance with Bonferroni correction. Results: The number of organizational root causes was reduced by 27% (p < 0.001). There was no effect on the percentage of patients included in trials. Conclusion: The reorganizational trajectory was successful for the primary end point of patient care and had no effect on clinical research. Some confounding events hampered our ability to draw strong conclusions. Nevertheless, the transparency of this approach can give medical professionals more confidence in moving forward with other organizational changes in the same way. Advances in knowledge: This article is novel because managerial interventions were set up similarly to a prospective clinical trial. This study is the first of its kind in radiotherapy, and this approach can contribute to discussions about the effectiveness of managerial interventions. PMID:25679320

  5. The predictive effect of insight on adverse clinical outcomes in bipolar I disorder: a two-year prospective study.

    PubMed

    Yen, Cheng-Fang; Chen, Cheng-Sheng; Yen, Ju-Yu; Ko, Chih-Hung

    2008-05-01

    Research has revealed that a lack of insight is associated with poorer clinical outcomes in schizophrenia; however, the predictive value of insight on adverse clinical outcomes among bipolar patients is quite understudied. The aim of this prospective study was to examine the impact of insight on adverse clinical outcomes among the patients with bipolar I disorder over a 2-year period. Sixty-five remitted bipolar I disorder patients received follow-up assessments at 3, 6, 9, 12, 18, and 24 months to detect the adverse clinical outcomes defined by the incidence of bipolar-related psychiatric hospitalization, emergency room visits, violent or suicidal behavior. The Schedule of Assessment of Insight was used to provide a baseline insight score. Cox regression analysis was used to examine the predictive value of insight on the adverse clinical outcomes. Impaired insight into treatment and a greater number of previous hospitalizations significantly increased the risk of adverse clinical outcomes with bipolar disorder in the 2-year period. However, insight into recognition of the illness and re-labeling of psychotic phenomena did not have any significant effect on adverse clinical outcomes. Bipolar patients' insight into treatment is an independent predictor of adverse clinical outcomes. Improving insight into treatment might be a promising target for a better outcome. PMID:17997489

  6. Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial.

    PubMed

    Müller, Dörte; Lindemann, Torben; Shah-Hosseini, Kija; Scherner, Olaf; Knop, Markus; Bilstein, Andreas; Mösges, Ralph

    2016-09-01

    The aim of this observational trial was to evaluate the efficacy and tolerability of a mouth and throat spray containing ectoine in the treatment of acute pharyngitis and/or laryngitis. The outcome was compared with control treatment using saline lozenges. This study was designed as a prospective, controlled, non-randomized, observational multicenter clinical trial and was conducted in Germany. The study population consisted of 95 patients. The decision for treatment with either spray or lozenges was based on the patients' preference for pharyngeal or oral application. Investigators assessed symptoms specific to acute pharyngitis/laryngitis and determined the pharyngitis symptom score. Both patients and investigators evaluated the tolerability and efficacy of the treatment applied. Treatment with the spray showed higher efficacy, 1.95 ± 0.81 versus 1.68 ± 0.67 (investigators) and 1.97 ± 0.88 versus 1.57 ± 0.69 (patients, p < 0.05). Treatment with the spray resulted in significantly greater reduction of cervical lymph node swelling (p < 0.05), ∆ spray = 0.44 ± 0.62, ∆ lozenges = 0.21 ± 0.62. The lozenges showed some advantage in relieving cough, ∆ lozenges = 0.62 ± 0.94 versus ∆ spray = 0.44 ± 0.85. Both patients and investigators rated the tolerability of both medical devices as "good" to "very good". Adverse events of mild to moderate severity were either possibly related or not related to the medical devices used. No serious adverse events occurred. Taken together, while the tolerability was consistent in both treatment groups, the ectoine-based spray showed superior efficacy in treating acute pharyngitis and/or laryngitis. PMID:27126336

  7. Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial.

    PubMed

    Müller, Dörte; Lindemann, Torben; Shah-Hosseini, Kija; Scherner, Olaf; Knop, Markus; Bilstein, Andreas; Mösges, Ralph

    2016-09-01

    The aim of this observational trial was to evaluate the efficacy and tolerability of a mouth and throat spray containing ectoine in the treatment of acute pharyngitis and/or laryngitis. The outcome was compared with control treatment using saline lozenges. This study was designed as a prospective, controlled, non-randomized, observational multicenter clinical trial and was conducted in Germany. The study population consisted of 95 patients. The decision for treatment with either spray or lozenges was based on the patients' preference for pharyngeal or oral application. Investigators assessed symptoms specific to acute pharyngitis/laryngitis and determined the pharyngitis symptom score. Both patients and investigators evaluated the tolerability and efficacy of the treatment applied. Treatment with the spray showed higher efficacy, 1.95 ± 0.81 versus 1.68 ± 0.67 (investigators) and 1.97 ± 0.88 versus 1.57 ± 0.69 (patients, p < 0.05). Treatment with the spray resulted in significantly greater reduction of cervical lymph node swelling (p < 0.05), ∆ spray = 0.44 ± 0.62, ∆ lozenges = 0.21 ± 0.62. The lozenges showed some advantage in relieving cough, ∆ lozenges = 0.62 ± 0.94 versus ∆ spray = 0.44 ± 0.85. Both patients and investigators rated the tolerability of both medical devices as "good" to "very good". Adverse events of mild to moderate severity were either possibly related or not related to the medical devices used. No serious adverse events occurred. Taken together, while the tolerability was consistent in both treatment groups, the ectoine-based spray showed superior efficacy in treating acute pharyngitis and/or laryngitis.

  8. New clinical decision rule to exclude subarachnoid haemorrhage for acute headache: a prospective multicentre observational study

    PubMed Central

    Kimura, Akio; Kobayashi, Kentaro; Yamaguchi, Hitoshi; Takahashi, Takeshi; Harada, Masahiro; Honda, Hideki; Mori, Yoshio; Hirose, Keika; Tanaka, Noriko

    2016-01-01

    Objective To ensure good outcomes in the management of subarachnoid haemorrhage (SAH), accurate prediction is crucial for initial assessment of patients presenting with acute headache. We conducted this study to develop a new clinical decision rule using only objectively measurable predictors to exclude SAH, offering higher specificity than the previous Ottawa SAH Rule while maintaining comparable sensitivity. Design Multicentre prospective cohort study. Setting Tertiary-care emergency departments of five general hospitals in Japan from April 2011 to March 2014. Participants Eligible patients comprised 1781 patients aged >15 years with acute headache, excluding trauma or toxic causes and patients who presented in an unconscious state. Main outcome measures Definitive diagnosis of SAH was based on confirmation of SAH on head CT or lumbar puncture findings of non-traumatic red blood cells or xanthochromia. Results A total of 1561 patients were enrolled in this study, of whom 277 showed SAH. Using these enrolled patients, we reached a rule with mainly categorical predictors used in previous reports, called the ‘Ottawa-like rule’, offering 100% sensitivity when using any of age ≥40 years, neck pain or stiffness, altered level of consciousness or onset during exertion. Using the 1317 patients from whom blood samples were obtained, a new rule using any of systolic blood pressure >150 mm Hg, diastolic blood pressure >90 mm Hg, blood sugar >115 mg/dL or serum potassium <3.9 mEq/L offered 100% sensitivity (95% CI 98.6% to 100%) and 14.5% specificity (12.5% to 16.9%), while the Ottawa-like rule showed the same sensitivity with a lower specificity of 8.8% (7.2% to 10.7%). Conclusions While maintaining equal sensitivity, our new rule seemed to offer higher specificity than the previous rules proposed by the Ottawa group. Despite the need for blood sampling, this method can reduce unnecessary head CT in patients with acute headache. Trial registration

  9. Untreated clinical course of cerebral cavernous malformations: a prospective, population-based cohort study

    PubMed Central

    Salman, Rustam Al-Shahi; Hall, Julie M; Horne, Margaret A; Moultrie, Fiona; Josephson, Colin B; Bhattacharya, Jo J; Counsell, Carl E; Murray, Gordon D; Papanastassiou, Vakis; Ritchie, Vaughn; Roberts, Richard C; Sellar, Robin J; Warlow, Charles P

    2012-01-01

    Summary Background Cerebral cavernous malformations (CCMs) are prone to bleeding but the risk of intracranial haemorrhage and focal neurological deficits, and the factors that might predict their occurrence, are unclear. We aimed to quantify these risks and investigate whether they are affected by sex and CCM location. Methods We undertook a population-based study using multiple overlapping sources of case ascertainment (including a Scotland-wide collaboration of neurologists, neurosurgeons, stroke physicians, radiologists, and pathologists, as well as searches of registers of hospital discharges and death certificates) to identify definite CCM diagnoses first made in Scottish residents between 1999 and 2003, which study neuroradiologists independently validated. We used multiple sources of prospective follow-up both to identify outcome events (which were assessed by use of brain imaging, by investigators masked to potential predictive factors) and to assess adults' dependence. The primary outcome was a composite of intracranial haemorrhage or focal neurological deficits (not including epileptic seizure) that were definitely or possibly related to CCM. Findings 139 adults had at least one definite CCM and 134 were alive at initial presentation. During 1177 person-years of follow-up (completeness 97%), for intracranial haemorrhage alone the 5-year risk of a first haemorrhage was lower than the risk of recurrent haemorrhage (2·4%, 95% CI 0·0–5·7 vs 29·5%, 4·1–55·0; p<0·0001). For the primary outcome, the 5-year risk of a first event was lower than the risk of recurrence (9·3%, 3·1–15·4 vs 42·4%, 26·8–58·0; p<0·0001). The annual risk of recurrence of the primary outcome declined from 19·8% (95% CI 6·1–33·4) in year 1 to 5·0% (0·0–14·8) in year 5 and was higher for women than men (p=0·01) but not for adults with brainstem CCMs versus CCMs in other locations (p=0·17). Interpretation The risk of recurrent intracranial haemorrhage or

  10. The non-random walk of chiral magnetic charge carriers in artificial spin ice

    PubMed Central

    Zeissler, K.; Walton, S. K.; Ladak, S.; Read, D. E.; Tyliszczak, T.; Cohen, L. F.; Branford, W. R.

    2013-01-01

    The flow of magnetic charge carriers (dubbed magnetic monopoles) through frustrated spin ice lattices, governed simply by Coulombic forces, represents a new direction in electromagnetism. Artificial spin ice nanoarrays realise this effect at room temperature, where the magnetic charge is carried by domain walls. Control of domain wall path is one important element of utilizing this new medium. By imaging the transit of domain walls across different connected 2D honeycomb structures we contribute an important aspect which will enable that control to be realized. Although apparently equivalent paths are presented to a domain wall as it approaches a Y-shaped vertex from a bar parallel to the field, we observe a stark non-random path distribution, which we attribute to the chirality of the magnetic charges. These observations are supported by detailed statistical modelling and micromagnetic simulations. The identification of chiral control to magnetic charge path selectivity invites analogy with spintronics. PMID:23409243

  11. Non-random mating in classical lekking grouse species: seasonal and diurnal trends

    NASA Astrophysics Data System (ADS)

    Tsuji, L. J. S.; DeIuliis, G.; Hansell, R. I. C.; Kozlovic, D. R.; Sokolowski, M. B.

    This paper is the first to integrate both field and theoretical approaches to demonstrate that fertility benefits can be a direct benefit to females mating on the classical lek. Field data collected for male sharp-tailed grouse (Tympanuchus phasianellus), a classical lekking species, revealed potential fertility benefits for selective females. Adult males and individuals occupying centrally located territories on the lek were found to have significantly larger testes than juveniles and peripheral individuals. Further, using empirical data from previously published studies of classical lekking grouse species, time-series analysis was employed to illustrate that female mating patterns, seasonal and daily, were non-random. We are the first to show that these patterns coincide with times when male fertility is at its peak.

  12. Non-random aneuploidy specifies subgroups of pilocytic astrocytoma and correlates with older age

    PubMed Central

    Khuong-Quang, Dong-Anh; Bechet, Denise; Gayden, Tenzin; Kool, Marcel; De Jay, Nicolas; Jacob, Karine; Gerges, Noha; Hutter, Barbara; Şeker-Cin, Huriye; Witt, Hendrik; Montpetit, Alexandre; Brunet, Sébastien; Lepage, Pierre; Bourret, Geneviève; Klekner, Almos; Bognár, László; Hauser, Peter; Garami, Miklós; Farmer, Jean-Pierre; Montes, Jose-Luis; Atkinson, Jeffrey; Lambert, Sally; Kwan, Tony; Korshunov, Andrey; Tabori, Uri; Collins, V. Peter; Albrecht, Steffen; Faury, Damien; Pfister, Stefan M.; Paulus, Werner; Hasselblatt, Martin; Jones, David T.W.; Jabado, Nada

    2015-01-01

    Pilocytic astrocytoma (PA) is the most common brain tumor in children but is rare in adults, and hence poorly studied in this age group. We investigated 222 PA and report increased aneuploidy in older patients. Aneuploid genomes were identified in 45% of adult compared with 17% of pediatric PA. Gains were non-random, favoring chromosomes 5, 7, 6 and 11 in order of frequency, and preferentially affecting non-cerebellar PA and tumors with BRAF V600E mutations and not with KIAA1549-BRAF fusions or FGFR1 mutations. Aneuploid PA differentially expressed genes involved in CNS development, the unfolded protein response, and regulators of genomic stability and the cell cycle (MDM2, PLK2),whose correlated programs were overexpressed specifically in aneuploid PA compared to other glial tumors. Thus, convergence of pathways affecting the cell cycle and genomic stability may favor aneuploidy in PA, possibly representing an additional molecular driver in older patients with this brain tumor. PMID:26378811

  13. A prospective, multi-center clinical and radiographic outcomes evaluation of ChronOS strip for lumbar spine fusion.

    PubMed

    Kanter, Adam S; Gandhoke, Gurpreet S; Welch, William C; Arnold, Paul M; Cheng, Joseph S; Okonkwo, David O

    2016-03-01

    This prospective clinical study evaluated the use of a composite bone void filler (ChronOS Strip, DePuy Synthes, West Chester, PA, USA), combined with bone marrow aspirate plus local autologous bone, in a series of patients undergoing instrumented posterolateral spinal fusion with interbody support. Seventy-six patients were enrolled and treated per protocol at 13 clinical sites. At 24 months, 55/76 patients (72%) were evaluated, with 49/76 (65%) having sufficient data to determine the primary endpoint. The primary endpoint, posterolateral fusion success, was achieved in 48/54 (88.9%) patients at 12 months and in 45/49 (91.8%) patients at 24 months. At all follow-up time points, statistically significant improvements were observed when compared to baseline in back and leg pain and functional status as measured by visual analog scale, Oswestry Disability Index and 12-Item Short Form health surveys. This prospective multi-center series provides evidence that the composite bone void filler, when applied posterolaterally with instrumentation, bone marrow aspirate and/or local autologous bone and concomitant interbody support, can be used to achieve a successful posterolateral fusion, resulting in improvements in clinical outcomes in patients with degenerative disc disease.

  14. A novel synthetic material for spinal fusion: a prospective clinical trial of porous bioactive titanium metal for lumbar interbody fusion.

    PubMed

    Fujibayashi, Shunsuke; Takemoto, Mitsuru; Neo, Masashi; Matsushita, Tomiharu; Kokubo, Tadashi; Doi, Kenji; Ito, Tatsuya; Shimizu, Akira; Nakamura, Takashi

    2011-09-01

    The objective of this study was to establish the efficacy and safety of porous bioactive titanium metal for use in a spinal fusion device, based on a prospective human clinical trial. A high-strength spinal interbody fusion device was manufactured from porous titanium metal. A bioactive surface was produced by simple chemical and thermal treatment. Five patients with unstable lumbar spine disease were treated surgically using this device in a clinical trial approved by our Ethics Review Committee and the University Hospital Medical Information Network. Clinical and radiological results were reported at the minimum follow-up period of 1 year. The optimal mechanical strength and interconnected structure of the porous titanium metal were adjusted for the device. The whole surface of porous titanium metal was treated uniformly and its bioactive ability was confirmed before clinical use. Successful bony union was achieved in all cases within 6 months without the need for autologous iliac crest bone grafting. Two specific findings including an anchoring effect and gap filling were evident radiologically. All clinical parameters improved significantly after the operation and no adverse effects were encountered during the follow-up period. Although a larger and longer-term follow-up clinical study is mandatory to reach any firm conclusions, the study results show that this porous bioactive titanium metal is promising material for a spinal fusion device.

  15. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    PubMed

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today. PMID:24451886

  16. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    PubMed

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today.

  17. Non-random decay of chordate characters causes bias in fossil interpretation.

    PubMed

    Sansom, Robert S; Gabbott, Sarah E; Purnell, Mark A

    2010-02-11

    Exceptional preservation of soft-bodied Cambrian chordates provides our only direct information on the origin of vertebrates. Fossil chordates from this interval offer crucial insights into how the distinctive body plan of vertebrates evolved, but reading this pre-biomineralization fossil record is fraught with difficulties, leading to controversial and contradictory interpretations. The cause of these difficulties is taphonomic: we lack data on when and how important characters change as they decompose, resulting in a lack of constraint on anatomical interpretation and a failure to distinguish phylogenetic absence of characters from loss through decay. Here we show, from experimental decay of amphioxus and ammocoetes, that loss of chordate characters during decay is non-random: the more phylogenetically informative are the most labile, whereas plesiomorphic characters are decay resistant. The taphonomic loss of synapomorphies and relatively higher preservation potential of chordate plesiomorphies will thus result in bias towards wrongly placing fossils on the chordate stem. Application of these data to Cathaymyrus (Cambrian period of China) and Metaspriggina (Cambrian period of Canada) highlights the difficulties: these fossils cannot be placed reliably in the chordate or vertebrate stem because they could represent the decayed remains of any non-biomineralized, total-group chordate. Preliminary data suggest that this decay filter also affects other groups of organisms and that 'stem-ward slippage' may be a widespread but currently unrecognized bias in our understanding of the early evolution of a number of phyla.

  18. Random and non-random mating populations: Evolutionary dynamics in meiotic drive.

    PubMed

    Sarkar, Bijan

    2016-01-01

    Game theoretic tools are utilized to analyze a one-locus continuous selection model of sex-specific meiotic drive by considering nonequivalence of the viabilities of reciprocal heterozygotes that might be noticed at an imprinted locus. The model draws attention to the role of viability selections of different types to examine the stable nature of polymorphic equilibrium. A bridge between population genetics and evolutionary game theory has been built up by applying the concept of the Fundamental Theorem of Natural Selection. In addition to pointing out the influences of male and female segregation ratios on selection, configuration structure reveals some noted results, e.g., Hardy-Weinberg frequencies hold in replicator dynamics, occurrence of faster evolution at the maximized variance fitness, existence of mixed Evolutionarily Stable Strategy (ESS) in asymmetric games, the tending evolution to follow not only a 1:1 sex ratio but also a 1:1 different alleles ratio at particular gene locus. Through construction of replicator dynamics in the group selection framework, our selection model introduces a redefining bases of game theory to incorporate non-random mating where a mating parameter associated with population structure is dependent on the social structure. Also, the model exposes the fact that the number of polymorphic equilibria will depend on the algebraic expression of population structure. PMID:26524140

  19. Non-random assembly of bacterioplankton communities in the subtropical north pacific ocean.

    PubMed

    Eiler, Alexander; Hayakawa, Darin H; Rappé, Michael S

    2011-01-01

    The exploration of bacterial diversity in the global ocean has revealed new taxa and previously unrecognized metabolic potential; however, our understanding of what regulates this diversity is limited. Using terminal restriction fragment length polymorphism (T-RFLP) data from bacterial small-subunit ribosomal RNA genes we show that, independent of depth and time, a large fraction of bacterioplankton co-occurrence patterns are non-random in the oligotrophic North Pacific subtropical gyre (NPSG). Pair-wise correlations of all identified operational taxonomic units (OTUs) revealed a high degree of significance, with 6.6% of the pair-wise co-occurrences being negatively correlated and 20.7% of them being positive. The most abundant OTUs, putatively identified as Prochlorococcus, SAR11, and SAR116 bacteria, were among the most correlated OTUs. As expected, bacterial community composition lacked statistically significant patterns of seasonality in the mostly stratified water column except in a few depth horizons of the sunlit surface waters, with higher frequency variations in community structure apparently related to populations associated with the deep chlorophyll maximum. Communities were structured vertically into epipelagic, mesopelagic, and bathypelagic populations. Permutation-based statistical analyses of T-RFLP data and their corresponding metadata revealed a broad range of putative environmental drivers controlling bacterioplankton community composition in the NPSG, including concentrations of inorganic nutrients and phytoplankton pigments. Together, our results suggest that deterministic forces such as environmental filtering and interactions among taxa determine bacterioplankton community patterns, and consequently affect ecosystem functions in the NPSG.

  20. The MHC and non-random mating in a captive population of Chinook salmon.

    PubMed

    Neff, B D; Garner, S R; Heath, J W; Heath, D D

    2008-08-01

    Detailed analysis of variation in reproductive success can provide an understanding of the selective pressures that drive the evolution of adaptations. Here, we use experimental spawning channels to assess phenotypic and genotypic correlates of reproductive success in Chinook salmon (Oncorhynchus tshawytscha). Groups of 36 fish in three different sex ratios (1:2, 1:1 and 2:1) were allowed to spawn and the offspring were collected after emergence from the gravel. Microsatellite genetic markers were used to assign parentage of each offspring, and the parents were also typed at the major histocompatibility class IIB locus (MHC). We found that large males, and males with brighter coloration and a more green/blue hue on their lateral integument sired more offspring, albeit only body size and brightness had independent effects. There was no similar relationship between these variables and female reproductive success. Furthermore, there was no effect of sex ratio on the strength or significance of any of the correlations. Females mated non-randomly at the MHC, appearing to select mates that produced offspring with greater genetic diversity as measured by amino-acid divergence. Females mated randomly with respect to male genetic relatedness and males mated randomly with respect to both MHC and genetic relatedness. These results indicate that sexual selection favours increased body size and perhaps integument coloration in males as well as increases genetic diversity at the MHC by female mate choice.

  1. Synaptic signal streams generated by ex vivo neuronal networks contain non-random, complex patterns.

    PubMed

    Lee, Sangmook; Zemianek, Jill M; Shultz, Abraham; Vo, Anh; Maron, Ben Y; Therrien, Mikaela; Courtright, Christina; Guaraldi, Mary; Yanco, Holly A; Shea, Thomas B

    2014-11-01

    Cultured embryonic neurons develop functional networks that transmit synaptic signals over multiple sequentially connected neurons as revealed by multi-electrode arrays (MEAs) embedded within the culture dish. Signal streams of ex vivo networks contain spikes and bursts of varying amplitude and duration. Despite the random interactions inherent in dissociated cultures, neurons are capable of establishing functional ex vivo networks that transmit signals among synaptically connected neurons, undergo developmental maturation, and respond to exogenous stimulation by alterations in signal patterns. These characteristics indicate that a considerable degree of organization is an inherent property of neurons. We demonstrate herein that (1) certain signal types occur more frequently than others, (2) the predominant signal types change during and following maturation, (3) signal predominance is dependent upon inhibitory activity, and (4) certain signals preferentially follow others in a non-reciprocal manner. These findings indicate that the elaboration of complex signal streams comprised of a non-random distribution of signal patterns is an emergent property of ex vivo neuronal networks.

  2. Non-Random Assembly of Bacterioplankton Communities in the Subtropical North Pacific Ocean

    PubMed Central

    Eiler, Alexander; Hayakawa, Darin H.; Rappé, Michael S.

    2011-01-01

    The exploration of bacterial diversity in the global ocean has revealed new taxa and previously unrecognized metabolic potential; however, our understanding of what regulates this diversity is limited. Using terminal restriction fragment length polymorphism (T-RFLP) data from bacterial small-subunit ribosomal RNA genes we show that, independent of depth and time, a large fraction of bacterioplankton co-occurrence patterns are non-random in the oligotrophic North Pacific subtropical gyre (NPSG). Pair-wise correlations of all identified operational taxonomic units (OTUs) revealed a high degree of significance, with 6.6% of the pair-wise co-occurrences being negatively correlated and 20.7% of them being positive. The most abundant OTUs, putatively identified as Prochlorococcus, SAR11, and SAR116 bacteria, were among the most correlated OTUs. As expected, bacterial community composition lacked statistically significant patterns of seasonality in the mostly stratified water column except in a few depth horizons of the sunlit surface waters, with higher frequency variations in community structure apparently related to populations associated with the deep chlorophyll maximum. Communities were structured vertically into epipelagic, mesopelagic, and bathypelagic populations. Permutation-based statistical analyses of T-RFLP data and their corresponding metadata revealed a broad range of putative environmental drivers controlling bacterioplankton community composition in the NPSG, including concentrations of inorganic nutrients and phytoplankton pigments. Together, our results suggest that deterministic forces such as environmental filtering and interactions among taxa determine bacterioplankton community patterns, and consequently affect ecosystem functions in the NPSG. PMID:21747815

  3. Current status and future prospects of the development of clinical Pharmacy in China: A SWOT analysis.

    PubMed

    Rao, Yuefeng; Zhao, Qingwei; Zhang, Xiangyi; Yang, Hongyu; Lou, Yan; Zhang, Xingguo

    2016-03-01

    In many industrialized countries, clinical pharmacy has developed into a separate discipline and become a vital part of inpatient care in hospitals. However, as compared to many established branches of medicine, clinical pharmacy is still in its infancy, with much room for growth, improvement, and recognition by both the medical community and patients. In this study, a widely-recognized development strategy analysis tool, Strength, Weakness, Opportunity and Threat (SWOT), was used to systematically address several key issues to the development of clinical pharmacy in China. This analysis aims to provide feasible recommendations for the development of clinical pharmacy in China by identifying current problems and growth opportunities. Full development of clinical pharmacy as a mature clinical discipline will help promote the rational use of drugs by both clinicians and patients and lead to enhanced drug efficacy and safety. PMID:27087089

  4. Current status and future prospects of the development of clinical Pharmacy in China: A SWOT analysis.

    PubMed

    Rao, Yuefeng; Zhao, Qingwei; Zhang, Xiangyi; Yang, Hongyu; Lou, Yan; Zhang, Xingguo

    2016-03-01

    In many industrialized countries, clinical pharmacy has developed into a separate discipline and become a vital part of inpatient care in hospitals. However, as compared to many established branches of medicine, clinical pharmacy is still in its infancy, with much room for growth, improvement, and recognition by both the medical community and patients. In this study, a widely-recognized development strategy analysis tool, Strength, Weakness, Opportunity and Threat (SWOT), was used to systematically address several key issues to the development of clinical pharmacy in China. This analysis aims to provide feasible recommendations for the development of clinical pharmacy in China by identifying current problems and growth opportunities. Full development of clinical pharmacy as a mature clinical discipline will help promote the rational use of drugs by both clinicians and patients and lead to enhanced drug efficacy and safety.

  5. Gait and clinical measurements in patients with knee osteoarthritis after surgery: a prospective 5-year follow-up study.

    PubMed

    Börjesson, M; Weidenhielm, L; Mattsson, E; Olsson, E

    2005-04-01

    The aim of this prospective follow-up study was to determine if gait measurements and/or clinical measurements could detect differences in treatment outcome between two surgical interventions in patients with knee osteoarthritis (OA). The patients were followed for 5 years after surgery. Forty patients, 55-70 years of age, with unilateral knee OA were included. The patients were treated either with a high tibial osteotomy (HTO) (n=18) or a unicompartmental knee arthroplasty (UKA) (n=22). Clinical outcome measures were the British Orthopaedic Association (BOA) score, pain during walking, passive range of knee motion (PROM) and patients' subjective opinion. The gait variables were free walking speed, step frequency, step length and single and double-stance phase for each leg. The patients were examined before surgery and 3 months, 1 year and 5 years after surgery. The time-distance variables of gait could detect differences in treatment outcome, 3 months after surgery, while the clinical outcome measures, as given here, could not detect any differences between the two groups of patients. Measurements of free walking speed could be recommended for clinical evaluation, after surgical interventions, in patients with knee OA.

  6. Clinical procedures and practices used in the perioperative treatment of female genital fistula during a prospective cohort study

    PubMed Central

    2014-01-01

    Background Treatment and care for female genital fistula have become increasingly available over the last decade in countries across Africa and South Asia. Before the International Federation of Gynaecology and Obstetrics (FIGO) and partners published a global fistula training manual in 2011 there was no internationally recognized, standardized training curriculum, including perioperative care. The community of fistula care practitioners and advocates lacks data about the prevalence of various perioperative clinical procedures and practices and their potential programmatic implications are lacking. Methods Data presented here are from a prospective cohort study conducted between September 2007 and September 2010 at 11 fistula repair facilities supported by Fistula Care in five countries. Clinical procedures and practices used in the routine perioperative management of over 1300 women are described. Results More than two dozen clinical procedures and practices were tabulated. Some of them were commonly used at all sites (e.g., vaginal route of repair, 95.3% of cases); others were rare (e.g., flaps/grafts, 3.4%) or varied widely depending on site (e.g. for women with urinary fistula, the inter-quartile range for median duration of post-repair bladder catheterization was 14 to 29 days). Conclusions These findings show a wide range of clinical procedures and practices with different program implications for safety, efficacy, and cost-effectiveness. The variability indicates the need for further research so as to strengthen the evidence base for fistula treatment in developing countries. PMID:24996561

  7. A review of prospective Clinical Trials for neurogenic bladder: The place of surgery, experimental techniques and devices

    PubMed Central

    Braschi, Emmanuel; Lavelle, John

    2014-01-01

    Introduction The neurogenic urinary bladder has been known for at least 30 years now and the concepts behind it are continuously evolving, but there is actually not much work that has been done to accumulate solid clinical evidence in this field. We review the surgical and experimental techniques used in the management of this condition. Material and methods To achieve our goal, we performed Internet searches using the same search string: Urinary bladder, neurogenic. In each case, the search was limited to clinical trial, subjects were human and the language was English. After duplicate removal, we obtained a final number of 580 papers. Data was extracted from each paper into a database file and was analyzed separately for adult and pediatric populations. Results A total of 70 full text papers were reviewed and analyzed according to the previously mentioned algorithm. The first prospective, randomized surgical trials were published less than 20 years ago, starting with 1994, and the number of papers published each year since then has remained in the range of 1–3. The oldest prospective clinical trial for this indication dates back to 1975. The total number of patients included in surgical trials is 3453, out of which 59% are males. The papers include a total of 369 children (21.2%), essentially looking at all the techniques that are also used in adults. Conclusions There is still a lot of work to be done in order to obtain a significant level of evidence in the field of surgical procedures used in neurogenic bladder patients. PMID:25247086

  8. Plasticity-Driven Self-Organization under Topological Constraints Accounts for Non-random Features of Cortical Synaptic Wiring

    PubMed Central

    Miner, Daniel; Triesch, Jochen

    2016-01-01

    Understanding the structure and dynamics of cortical connectivity is vital to understanding cortical function. Experimental data strongly suggest that local recurrent connectivity in the cortex is significantly non-random, exhibiting, for example, above-chance bidirectionality and an overrepresentation of certain triangular motifs. Additional evidence suggests a significant distance dependency to connectivity over a local scale of a few hundred microns, and particular patterns of synaptic turnover dynamics, including a heavy-tailed distribution of synaptic efficacies, a power law distribution of synaptic lifetimes, and a tendency for stronger synapses to be more stable over time. Understanding how many of these non-random features simultaneously arise would provide valuable insights into the development and function of the cortex. While previous work has modeled some of the individual features of local cortical wiring, there is no model that begins to comprehensively account for all of them. We present a spiking network model of a rodent Layer 5 cortical slice which, via the interactions of a few simple biologically motivated intrinsic, synaptic, and structural plasticity mechanisms, qualitatively reproduces these non-random effects when combined with simple topological constraints. Our model suggests that mechanisms of self-organization arising from a small number of plasticity rules provide a parsimonious explanation for numerous experimentally observed non-random features of recurrent cortical wiring. Interestingly, similar mechanisms have been shown to endow recurrent networks with powerful learning abilities, suggesting that these mechanism are central to understanding both structure and function of cortical synaptic wiring. PMID:26866369

  9. Dynamic Cervical Implant versus Anterior Cervical Diskectomy and Fusion: A Prospective Study of Clinical and Radiologic Outcome.

    PubMed

    Richter, Heiko; Seule, Martin; Hildebrandt, Gerhard; Fournier, Jean-Yves

    2016-07-01

    Objective To evaluate clinical and radiologic outcome in patients treated with a dynamic cervical implant (DCI) or anterior cervical diskectomy and fusion (ACDF). Study Design A prospective comparative cohort study. Methods The study included 60 patients with one- or two-level cervical degenerative disk disease (DDD) undergoing treatment with either DCI (n = 30) or ACDF (n = 30). Clinical and radiologic outcomes were assessed 3 and 12 months after surgery. Clinical scoring systems included the Visual Analog Scale for Neck (VAS-N) and Arm pain (VAS-A), the Neck Pain and Disability Scale (NPAD), and the European Quality of Life Scale (EQ-5D). Results Both the DCI and ACDF group showed significant clinical improvement 12 months after surgery using the VAS-N (p = 0.034 and p < 0.001, respectively), VAS-A (p < 0.001 and p < 0.001, respectively), NPAD (p < 0.001 and p < 0.001, respectively), and EQ-5D (p < 0.001 and p < 0.001, respectively). There were no significant differences in clinical outcome comparing both groups at the 3- and 12-month follow-up. The fusion rate at 12 months after surgery was 39.4% and 80.0% in the DCI and ACDF groups, respectively. Radiolucency was found in 90.9% in the DCI group at 12-month follow-up. Conclusion The clinical results for DCI treatment are equivalent to those for ACDF in the treatment of one- and two-level cervical DDD at 12 months after surgery. Further studies are necessary to investigate the high rates of radiolucency and fusion associated with DCI treatment. PMID:27088592

  10. Dynamic Cervical Implant versus Anterior Cervical Diskectomy and Fusion: A Prospective Study of Clinical and Radiologic Outcome.

    PubMed

    Richter, Heiko; Seule, Martin; Hildebrandt, Gerhard; Fournier, Jean-Yves

    2016-07-01

    Objective To evaluate clinical and radiologic outcome in patients treated with a dynamic cervical implant (DCI) or anterior cervical diskectomy and fusion (ACDF). Study Design A prospective comparative cohort study. Methods The study included 60 patients with one- or two-level cervical degenerative disk disease (DDD) undergoing treatment with either DCI (n = 30) or ACDF (n = 30). Clinical and radiologic outcomes were assessed 3 and 12 months after surgery. Clinical scoring systems included the Visual Analog Scale for Neck (VAS-N) and Arm pain (VAS-A), the Neck Pain and Disability Scale (NPAD), and the European Quality of Life Scale (EQ-5D). Results Both the DCI and ACDF group showed significant clinical improvement 12 months after surgery using the VAS-N (p = 0.034 and p < 0.001, respectively), VAS-A (p < 0.001 and p < 0.001, respectively), NPAD (p < 0.001 and p < 0.001, respectively), and EQ-5D (p < 0.001 and p < 0.001, respectively). There were no significant differences in clinical outcome comparing both groups at the 3- and 12-month follow-up. The fusion rate at 12 months after surgery was 39.4% and 80.0% in the DCI and ACDF groups, respectively. Radiolucency was found in 90.9% in the DCI group at 12-month follow-up. Conclusion The clinical results for DCI treatment are equivalent to those for ACDF in the treatment of one- and two-level cervical DDD at 12 months after surgery. Further studies are necessary to investigate the high rates of radiolucency and fusion associated with DCI treatment.

  11. Prospects for clinical use of reprogrammed cells for autologous treatment of macular degeneration.

    PubMed

    Alvarez Palomo, Ana Belen; McLenachan, Samuel; Chen, Fred K; Da Cruz, Lyndon; Dilley, Rodney J; Requena, Jordi; Lucas, Michaela; Lucas, Andrew; Drukker, Micha; Edel, Michael J

    2015-01-01

    Since the discovery of induced pluripotent stem cells (iPSC) in 2006, the symptoms of many human diseases have been reversed in animal models with iPSC therapy, setting the stage for future clinical development. From the animal data it is clear that iPSC are rapidly becoming the lead cell type for cell replacement therapy and for the newly developing field of iPSC-derived body organ transplantation. The first human pathology that might be treated in the near future with iPSC is age-related macular degeneration (AMD), which has recently passed the criteria set down by regulators for phase I clinical trials with allogeneic human embryonic stem cell-derived cell transplantation in humans. Given that iPSC are currently in clinical trial in Japan (RIKEN) to treat AMD, the establishment of a set of international criteria to make clinical-grade iPSC and their differentiated progeny is the next step in order to prepare for future autologous cell therapy clinical trials. Armed with clinical-grade iPSC, we can then specifically test for their threat of cancer, for proper and efficient differentiation to the correct cell type to treat human disease and then to determine their immunogenicity. Such a rigorous approach sets a far more relevant paradigm for their intended future use than non-clinical-grade iPSC. This review focuses on the latest developments regarding the first possible use of iPSC-derived retinal pigment epithelial cells in treating human disease, covers data gathered on animal models to date and methods to make clinical-grade iPSC, suggests techniques to ensure quality control and discusses possible clinical immune responses.

  12. [Satisfaction of pharmacists in Lebanon and the prospect for clinical pharmacy].

    PubMed

    Antoun, R Bou; Salameh, P

    2009-01-01

    We conducted a questionnaire survey among community and pharmaceutical company pharmacists in Lebanon to evaluate their satisfaction with their professional status and their willingness to work as clinical pharmacists. The majority of community pharmacists were satisfied with their professional situation (> 50%), except for the financial aspect (40%). For pharmaceutical company pharmacists, only 33% thought that their profession had a positive image. However, > 65% were satisfied with social and financial standing. About 25% of pharmacists in pharmaceutical companies were ready to switch to clinical pharmacy with less income. Over 75% of the community pharmacists were prepared to apply clinical pharmacy in their practice and would be ready to attend courses for this purpose.

  13. Performance of statistical methods for analysing survival data in the presence of non-random compliance.

    PubMed

    Odondi, Lang'o; McNamee, Roseanne

    2010-12-20

    Noncompliance often complicates estimation of treatment efficacy from randomized trials. Under random noncompliance, per protocol analyses or even simple regression adjustments for noncompliance, could be adequate for causal inference, but special methods are needed when noncompliance is related to risk. For survival data, Robins and Tsiatis introduced the semi-parametric structural Causal Accelerated Life Model (CALM) which allows time-dependent departures from randomized treatment in either arm and relates each observed event time to a potential event time that would have been observed if the control treatment had been given throughout the trial. Alternatively, Loeys and Goetghebeur developed a structural Proportional Hazards (C-Prophet) model for when there is all-or-nothing noncompliance in the treatment arm only. Whitebiet al. proposed a 'complier average causal effect' method for Proportional Hazards estimation which allows time-dependent departures from randomized treatment in the active arm. A time-invariant version of this estimator (CHARM) consists of a simple adjustment to the Intention-to-Treat hazard ratio estimate. We used simulation studies mimicking a randomized controlled trial of active treatment versus control with censored time-to-event data, and under both random and non-random time-dependent noncompliance, to evaluate performance of these methods in terms of 95 per cent confidence interval coverage, bias and root mean square errors (RMSE). All methods performed well in terms of bias, even the C-Prophet used after treating time-varying compliance as all-or-nothing. Coverage of the latter method, as implemented in Stata, was too low. The CALM method performed best in terms of bias and coverage but had the largest RMSE. PMID:20963732

  14. Non-random correlation structures and dimensionality reduction in multivariate climate data

    NASA Astrophysics Data System (ADS)

    Vejmelka, Martin; Pokorná, Lucie; Hlinka, Jaroslav; Hartman, David; Jajcay, Nikola; Paluš, Milan

    2015-05-01

    It is well established that the global climate is a complex phenomenon with dynamics driven by the interaction of a multitude of identifiable but intertwined subsystems. The identification, at some level, of these subsystems is an important step towards understanding climate dynamics. We present a method to determine the number of principal components representing non-random correlation structures in climate data, or components that cannot be generated by a surrogate model of independent stochastic processes replicating the auto-correlation structure of each time series. The purpose of the method is to automatically reduce the dimensionality of large climate datasets into spatially localised components suitable for further interpretation or, for example, for use as nodes in a complex network analysis of large-scale climate dynamics. We apply the method to two 2.5° resolution NCEP/NCAR reanalysis global datasets of monthly means: the sea level pressure (SLP) and the surface air temperature (SAT), and extract 60 components explaining 87 % variance and 68 components explaining 72 % variance, respectively. The obtained components are in agreement with previous results in that they recover many well-known climate modes previously identified using other approaches including regionally constrained principal component analysis. Selected SLP components are discussed in more detail with respect to their correlation with important climate indices and their relationship to other SLP and SAT components. Finally, we consider a subset of the obtained components that have not yet been explicitly identified by other authors but seem plausible in the context of regional climate observations discussed in literature.

  15. Intrauterine synechiae after myomectomy; laparotomy versus laparoscopy: Non-randomized interventional trial

    PubMed Central

    Asgari, Zahra; Hafizi, Leili; Hosseini, Rayhaneh; Javaheri, Atiyeh; Rastad, Hathis

    2015-01-01

    Background: Leiomyomata is the most frequent gynecological neoplasm. One of the major complications of myomectomy is intrauterine adhesion (synechiae). Objective: To evaluate and compare the rate and severity of synechiae formation after myomectomy by laparotomy and laparoscopy. Materials and Methods: In this non-randomized interventional trial, hysteroscopy was performed in all married fertile women who had undergone myomectomy (type 3-6 interamural and subserosal fibroids) via laparotomy and laparoscopy in Tehran’s Arash Hospital from 2010 to 2013. Three months after the operation, the occurrence rate and severity of intrauterine synechiae, and its relationship with type, number and location of myomas were investigated and compared in both groups. Results: Forty patients (19 laparoscopy and 21 laparotomy cases) were studied. Both groups were similar regarding the size, type (subserosal or intramural), number and location of myoma. The occurrence rate of synechiae in the laparoscopy and laparotomy group was 21% and 19%, respectively; showing no significant difference (p=0.99). Among all patients, no significant relationship was found between the endometrial opening (p=0.92), location (p=0.14) and type of myoma (p=0.08) with the occurrence rate of synechiae. However, a significant relationship was observed between myoma’s size (p=0.01) and the location of the largest myoma with the occurrence of synechiae (p=0.02). Conclusion: With favorable suturing methods, the outcome of intrauterine synechiae formation after myomectomy, either performed by laparotomy or laparoscopy, is similar. In all cases of myomectomy in reproductive-aged women, postoperative hysteroscopy is highly recommended to better screen intrauterine synechiae. PMID:26000007

  16. Non-Random Integration of the HPV Genome in Cervical Cancer

    PubMed Central

    Schmitz, Martina; Driesch, Corina; Jansen, Lars; Runnebaum, Ingo B.; Dürst, Matthias

    2012-01-01

    HPV DNA integration into the host genome is a characteristic but not an exclusive step during cervical carcinogenesis. It is still a matter of debate whether viral integration contributes to the transformation process beyond ensuring the constitutive expression of the viral oncogenes. There is mounting evidence for a non-random distribution of integration loci and the direct involvement of cellular cancer-related genes. In this study we addressed this topic by extending the existing data set by an additional 47 HPV16 and HPV18 positive cervical carcinoma. We provide supportive evidence for previously defined integration hotspots and have revealed another cluster of integration sites within the cytogenetic band 3q28. Moreover, in the vicinity of these hotspots numerous microRNAs (miRNAs) are located and may be influenced by the integrated HPV DNA. By compiling our data and published reports 9 genes could be identified which were affected by HPV integration at least twice in independent tumors. In some tumors the viral-cellular fusion transcripts were even identical with respect to the viral donor and cellular acceptor sites used. However, the exact integration sites are likely to differ since none of the integration sites analysed thus far have shown more than a few nucleotides of homology between viral and host sequences. Therefore, DNA recombination involving large stretches of homology at the integration site can be ruled out. It is however intriguing that by sequence alignment several regions of the HPV16 genome were found to have highly homologous stretches of up to 50 nucleotides to the aforementioned genes and the integration hotspots. One common region of homologies with cellular sequences is between the viral gene E5 and L2 (nucleotides positions 4100 to 4240). We speculate that this and other regions of homology are involved in the integration process. Our observations suggest that targeted disruption, possibly also of critical cellular genes, by HPV

  17. Non-random fragmentation patterns in circulating cell-free DNA reflect epigenetic regulation

    PubMed Central

    2015-01-01

    Background The assessment of cell-free circulating DNA fragments, also known as a "liquid biopsy" of the patient's plasma, is an important source for the discovery and subsequent non-invasive monitoring of cancer and other pathological conditions. Although the nucleosome-guided fragmentation patterns of cell-free DNA (cfDNA) have not yet been studied in detail, non-random representation of cfDNA sequencies may reflect chromatin features in the tissue of origin at gene-regulation level. Results In this study, we investigated the association between epigenetic landscapes of human tissues evident in the patterns of cfDNA in plasma by deep sequencing of human cfDNA samples. We have demonstrated that baseline characteristics of cfDNA fragmentation pattern are in concordance with the ones corresponding to cell lines-derived. To identify the loci differentially represented in cfDNA fragment, we mapped the transcription start sites within the sequenced cfDNA fragments and tested for association of these genomic coordinates with the relative strength and the patterns of gene expressions. Preselected sets of house-keeping and tissue specific genes were used as models for actively expressed and silenced genes. Developed measure of gene regulation was able to differentiate these two sets based on sequencing coverage near gene transcription start site. Conclusion Experimental outcomes suggest that cfDNA retains characteristics previously noted in genome-wide analysis of chromatin structure, in particular, in MNase-seq assays. Thus far the analysis of the DNA fragmentation pattern may aid further developing of cfDNA based biomarkers for a variety of human conditions. PMID:26693644

  18. Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

    PubMed

    Sennerby, L; Gottlow, J

    2008-06-01

    Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3). PMID:18498589

  19. Clinical value of immunoscintigraphy in colorectal carcinoma patients: A prospective study

    SciTech Connect

    Bischof-Delaloye, A.; Delaloye, B.; Buchegger, F.; Gilgien, W.; Studer, A.; Curchod, S.; Givel, J.C.; Mosimann, F.; Pettavel, J.; Mach, J.P. )

    1989-10-01

    Fifty-seven patients with suspected CEA-producing tumors were studied prospectively by radioimmunoscintigraphy (RIS) using a 123I-labeled anti-CEA monoclonal antibody (MAb) (essentially the F(ab')2 or Fab fragments) and emission computed tomography (ECT). Results of RIS were compared to those of a comprehensive diagnostic study. Final diagnosis was based on surgery, biopsy and autopsy (n = 39) or follow-up findings (n = 18). Three groups of patients were defined: Group A with suspected primary tumors (n = 11), Group B with probable (n = 19) and Group C with questionable (n = 27) tumor relapse. Eighty-eight per cent, 93% and 71% of the anatomic regions studied were correctly identified as being involved, and 97%, 97%, and 87% as being free from tumor in Groups A, B, and C, respectively. In the 27 patients from Group C with no definite diagnosis of relapse, and in whom diagnosis was most difficult, 38 tumor sites were involved. Of these, 21 were detected by both prospective RIS and repeated comprehensive study, six by RIS only and seven by conventional methods only. Four sites remained undetected by both approaches. Ten of the 21 lesions were detected by RIS more than 1 mo earlier than by any other method. Among the seven tumor sites detected by other diagnostic modalities only, three were identified at the time of RIS and four became positive more than 6 mo later. Overall diagnosis was entirely correct in 30, partially correct in 16 and incorrect in six patients studied. RIS with ECT and 123I-labeled anti-CEA MAb allows early detection of recurrence or metastasis of colorectal cancer. It thus contributes to reduced delay between diagnosis and treatment.

  20. Clinical relevance of autophagic therapy in cancer: Investigating the current trends, challenges, and future prospects.

    PubMed

    Mukhopadhyay, Subhadip; Sinha, Niharika; Das, Durgesh Nandini; Panda, Prashanta Kumar; Naik, Prajna Paramita; Bhutia, Sujit Kumar

    2016-08-01

    Oncophagy (cancer-related autophagy) has a complex dual character at different stages of tumor progression. It remains an important clinical problem to unravel the reasons that propel the shift in the role of oncophagy from tumor inhibition to a protective mechanism that shields full-blown malignancy. Most treatment strategies emphasize curbing protective oncophagy while triggering the oncophagy that is lethal to tumor cells. In this review, we focus on the trends in current therapeutics as well as various challenges in clinical trials to address the oncophagic dilemma and evaluate the potential of these developing therapies. A detailed analysis of the clinical and pre-clinical scenario of the anticancer medicines highlights the various inducers and inhibitors of autophagy. The ways in which tumor stage, the microenvironment and combination drug treatment continue to play an important tactical role are discussed. Moreover, autophagy targets also play a crucial role in developing the best possible solution to this oncophagy paradox. In this review, we provide a comprehensive update on the current clinical impact of autophagy-based cancer therapeutic drugs and try to lessen the gap between translational medicine and clinical science.

  1. Isotope-dilution assay for urinary methylmalonic acid in the diagnosis of vitamin B12 deficiency. A prospective clinical evaluation

    SciTech Connect

    Matchar, D.B.; Feussner, J.R.; Millington, D.S.; Wilkinson, R.H. Jr.; Watson, D.J.; Gale, D.

    1987-05-01

    Vitamin B12 deficiency is a frequently considered diagnosis for which there is no single, commonly available and accurate test. A urinary methylmalonic acid assay using gas chromatography-mass spectrometry has been proposed as the preferred test. We reviewed vitamin B12 assays on 1599 consecutive patients and prospectively studied all patients with low serum B12 levels (n = 75) and a random sample of patients with normal levels (n = 68). Of 96 evaluable patients, 7 had clinical deficiency. All 7 deficient patients had urinary methylmalonic acid levels greater than 5 micrograms/mg creatine (sensitivity, 100%; confidence interval, 65% to 100%). Of the 89 patients who were not clinically deficient, 88 had urinary methylmalonic acid levels less than or equal to 5 micrograms/mg creatinine (specificity, 99%). The overall test accuracy in this population was 99%. If the high sensitivity and specificity of the gas chromatography-mass spectrometry assay for urinary methylmalonic acid is supported by other clinical studies, the methylmalonic acid assay may become the reference standard for the diagnosis of vitamin B12 deficiency.

  2. Prospective Clinical Trial for Septic Arthritis: Cartilage Degradation and Inflammation Are Associated with Upregulation of Cartilage Metabolites

    PubMed Central

    Bernstein, Anke; Pham, That Minh

    2016-01-01

    Background. Intra-articular infections can rapidly lead to osteoarthritic degradation. The aim of this clinical biomarker analysis was to investigate the influence of inflammation on cartilage destruction and metabolism. Methods. Patients with acute joint infections were enrolled in a prospective clinical trial and the cytokine composition of effusions (n = 76) was analyzed. Characteristics of epidemiology and disease severity were correlated with levels of cytokines with known roles in cartilage turnover and degradation. Results. Higher synovial IL-1β concentrations were associated with clinical parameters indicating a higher disease severity (p < 0.03) excluding the incidence of sepsis. Additionally, intra-articular IL-1β levels correlated with inflammatory serum parameters as leucocyte counts (LC) and C-reactive protein concentrations (p < 0.05) but not with age or comorbidity. Both higher LC and synovial IL-1β levels were associated with increased intra-articular collagen type II cleavage products (C2C) indicating cartilage degradation. Joints with preinfectious lesions had higher C2C levels. Intra-articular inflammation led to increased concentrations of typical cartilage metabolites as bFGF, BMP-2, and BMP-7. Infections with Staphylococcus species induced higher IL-1β expression but less cartilage destruction than other bacteria. Conclusion. Articular infections have bacteria-specific implications on cartilage metabolism. Collagen type II cleavage products reliably mark destruction, which is associated with upregulation of typical cartilage turnover cytokines. This trial is registered with DRKS00003536, MISSinG.

  3. Prospective Clinical Trial for Septic Arthritis: Cartilage Degradation and Inflammation Are Associated with Upregulation of Cartilage Metabolites

    PubMed Central

    Bernstein, Anke; Pham, That Minh

    2016-01-01

    Background. Intra-articular infections can rapidly lead to osteoarthritic degradation. The aim of this clinical biomarker analysis was to investigate the influence of inflammation on cartilage destruction and metabolism. Methods. Patients with acute joint infections were enrolled in a prospective clinical trial and the cytokine composition of effusions (n = 76) was analyzed. Characteristics of epidemiology and disease severity were correlated with levels of cytokines with known roles in cartilage turnover and degradation. Results. Higher synovial IL-1β concentrations were associated with clinical parameters indicating a higher disease severity (p < 0.03) excluding the incidence of sepsis. Additionally, intra-articular IL-1β levels correlated with inflammatory serum parameters as leucocyte counts (LC) and C-reactive protein concentrations (p < 0.05) but not with age or comorbidity. Both higher LC and synovial IL-1β levels were associated with increased intra-articular collagen type II cleavage products (C2C) indicating cartilage degradation. Joints with preinfectious lesions had higher C2C levels. Intra-articular inflammation led to increased concentrations of typical cartilage metabolites as bFGF, BMP-2, and BMP-7. Infections with Staphylococcus species induced higher IL-1β expression but less cartilage destruction than other bacteria. Conclusion. Articular infections have bacteria-specific implications on cartilage metabolism. Collagen type II cleavage products reliably mark destruction, which is associated with upregulation of typical cartilage turnover cytokines. This trial is registered with DRKS00003536, MISSinG. PMID:27688601

  4. Sclerostin Antibody Therapy for the Treatment of Osteoporosis: Clinical Prospects and Challenges

    PubMed Central

    MacNabb, Claire; Patton, D.; Hayes, J. S.

    2016-01-01

    It is estimated that over 200 million adults worldwide have osteoporosis, a disease that has increasing socioeconomic impact reflected by unsustainable costs associated with disability, fracture management, hospital stays, and treatment. Existing therapeutic treatments for osteoporosis are associated with a variety of issues relating to use, clinical predictability, and health risks. Consequently, additional novel therapeutic targets are increasingly sought. A promising therapeutic candidate is sclerostin, a Wnt pathway antagonist and, as such, a negative regulator of bone formation. Sclerostin antibody treatment has demonstrated efficacy and superiority compared to other anabolic treatments for increasing bone formation in both preclinical and clinical settings. Accordingly, it has been suggested that sclerostin antibody treatment is set to achieve market approval by 2017 and aggressively compete as the gold standard for osteoporotic treatment by 2021. In anticipation of phase III trial results which may potentially signify a significant step in achieving market approval here, we review the preclinical and clinical emergence of sclerostin antibody therapies for both osteoporosis and alternative applications. Potential clinical challenges are also explored as well as ongoing developments that may impact on the eventual clinical application of sclerostin antibodies as an effective treatment of osteoporosis. PMID:27313945

  5. Clinical Scores for Dyspnoea Severity in Children: A Prospective Validation Study

    PubMed Central

    Eggink, Hendriekje; Brand, Paul; Reimink, Roelien; Bekhof, Jolita

    2016-01-01

    Background In acute dyspnoeic children, assessment of dyspnoea severity and treatment response is frequently based on clinical dyspnoea scores. Our study aim was to validate five commonly used paediatric dyspnoea scores. Methods Fifty children aged 0–8 years with acute dyspnoea were clinically assessed before and after bronchodilator treatment, a subset of 27 children were videotaped and assessed twice by nine observers. The observers scored clinical signs necessary to calculate the Asthma Score (AS), Asthma Severity Score (ASS), Clinical Asthma Evaluation Score 2 (CAES-2), Pediatric Respiratory Assessment Measure (PRAM) and respiratory rate, accessory muscle use, decreased breath sounds (RAD). Results A total of 1120 observations were used to assess fourteen measurement properties within domains of validity, reliability and utility. All five dyspnoea scores showed overall poor results, scoring insufficiently on more than half of the quality criteria for measurement properties. The AS and PRAM were the most valid with good values on six and moderate values on three properties. Poor results were mainly due to insufficient measurement properties in the validity and reliability domains whereas utility properties were moderate to good in all scores. Conclusion This study shows that commonly used dyspnoea scores show insufficient validity and reliability to allow for clinical use without caution. PMID:27382963

  6. Non-random distribution of DNA double-strand breaks induced by particle irradiation

    NASA Technical Reports Server (NTRS)

    Lobrich, M.; Cooper, P. K.; Rydberg, B.; Chatterjee, A. (Principal Investigator)

    1996-01-01

    Induction of DNA double-strand breaks (dsbs) in mammalian cells is dependent on the spatial distribution of energy deposition from the ionizing radiation. For high LET particle radiations the primary ionization sites occur in a correlated manner along the track of the particles, while for X-rays these sites are much more randomly distributed throughout the volume of the cell. It can therefore be expected that the distribution of dsbs linearly along the DNA molecule also varies with the type of radiation and the ionization density. Using pulsed-field gel and conventional gel techniques, we measured the size distribution of DNA molecules from irradiated human fibroblasts in the total range of 0.1 kbp-10 Mbp for X-rays and high LET particles (N ions, 97 keV/microns and Fe ions, 150 keV/microns). On a mega base pair scale we applied conventional pulsed-field gel electrophoresis techniques such as measurement of the fraction of DNA released from the well (FAR) and measurement of breakage within a specific NotI restriction fragment (hybridization assay). The induction rate for widely spaced breaks was found to decrease with LET. However, when the entire distribution of radiation-induced fragments was analysed, we detected an excess of fragments with sizes below about 200 kbp for the particles compared with X-irradiation. X-rays are thus more effective than high LET radiations in producing large DNA fragments but less effective in the production of smaller fragments. We determined the total induction rate of dsbs for the three radiations based on a quantitative analysis of all the measured radiation-induced fragments and found that the high LET particles were more efficient than X-rays at inducing dsbs, indicating an increasing total efficiency with LET. Conventional assays that are based only on the measurement of large fragments are therefore misleading when determining total dsb induction rates of high LET particles. The possible biological significance of this non-randomness

  7. Prospective clinical study of a new adhesive gelling foam dressing in pressure ulcers.

    PubMed

    Parish, Lawrence Charles; Dryjski, Maciej; Cadden, Sue

    2008-03-01

    This prospective, non comparative study evaluated the safety and effectiveness of an adhesive gelling foam dressing in pressure ulcer management. Twenty-three subjects with exuding pressure ulcers were recruited from seven centres in the USA and Canada. Study treatment included an adhesive gelling foam dressing, optional tape/roll bandaging and mandatory pressure-reducing/relieving devices. Subjects were followed until ulcer healing, for up to 28 days, or on patient withdrawal from the study, whichever came first. Dressings were changed at least once every 7 days. Mean percentage change in ulcer area from baseline to final measurement was -13%. Investigators reported healing or subjective improvement of ulcer condition in 61% of patients. Mean dressing wear time was 4.2 days. Subjects found the dressing was comfortable, soothing and cushioning in situ at 80%, 64% and 70% of dressing changes, respectively. Subjects reported pain severity of none or mild for every dressing change. Fourteen subjects experienced adverse events, including seven subjects with study-related maceration, erythema, wound enlargement, blister or infection. A regimen including an adhesive gelling foam dressing proved to be safe and effective for managing exudate, protecting the surrounding skin, minimising pain and supporting healing of pressure ulcers with exudate.

  8. Prospective Clinical Study of 551 Cases of Liposuction and Abdominoplasty Performed Individually and in Combination

    PubMed Central

    2013-01-01

    Background: Despite the popularity of these procedures, there are limited published prospective studies evaluating liposuction and abdominoplasty. Lipoabdominoplasty is a subject of recent attention. Several investigators have recommended alternative techniques that preserve the Scarpa fascia in an effort to reduce complications, particularly the risk of seromas. Methods: Over a 5-year period, 551 consecutive patients were treated with ultrasonic liposuction alone (n = 384), liposuction/abdominoplasty (n = 150), or abdominoplasty alone (n = 17). In lipoabdominoplasties, the abdomen and flanks were first treated with liposuction. A traditional flap dissection was used for all abdominoplasties. Scalpel dissection was used rather than electrodissection. A supine “jackknife” position was used in surgery to provide maximum hip flexion, allowing a secure deep fascial repair. Results: The complication rate after liposuction was 4.2% vs 50% for patients treated with an abdominoplasty. Approximately half of the abdominoplasty complications were minor scar deformities, including widened umbilical scars (17.3%) that were revised. The seroma rate after abdominoplasties was 5.4%; there were no seromas after liposuction alone. Conclusions: Lipoabdominoplasty may be performed safely, so that patients may benefit from both modalities. The seroma rate is reduced by avoiding electrodissection, making Scarpa fascia preservation a moot point. A deep fascial repair keeps the abdominoplasty scar within the bikini line. Deep venous thrombosis and other complications may be minimized with precautions that do not include anticoagulation. PMID:25289226

  9. Risk factors for postoperative infectious complications following percutaneous nephrolithotomy: a prospective clinical study.

    PubMed

    Koras, Omer; Bozkurt, Ibrahim Halil; Yonguc, Tarik; Degirmenci, Tansu; Arslan, Burak; Gunlusoy, Bulent; Aydogdu, Ozgu; Minareci, Suleyman

    2015-02-01

    The aim of the study was to assess the preoperative and intraoperative potential risk factors for infectious complications after percutaneous nephrolithotomy (PCNL). A total of 303 patients who underwent PCNL for renal stones were included in the recent study. A detailed history including past renal surgery, nephrostomy insertion and recurrent urinary infection were obtained from all patients. Preoperative urine culture, renal pelvic urine culture and stone culture were obtained from all patients. The intraoperative data were prospectively noted. All patients were followed up postoperatively for signs of systemic inflammatory response syndrome (SIRS) and sepsis. In 83 (27.4%) of the patients, SIRS was observed and of these patients 23 (7.6%) were diagnosed as sepsis. Escherichia coli was the most common organism detected in cultures, followed by Pseudomonas aeruginosa, Enterococcus and Klebsiella spp. in all patients. By multivariate logistic regression analysis, presence of infection stone, stone burden and recurrent urinary tract infection were associated with both SIRS and sepsis development. Presence of infection stone, stone burden ≥800 mm(2) and recurrent urinary tract infection can be identified as independent predictors for the development of SIRS and sepsis. PMID:25269441

  10. Membranoproliferative glomerulonephritis. A prospective clinical trial of platelet-inhibitor therapy

    SciTech Connect

    Donadio, J.V. Jr.; Anderson, C.F.; Mitchell, J.C.; Holley, K.E.; Ilstrup, D.M.; Fuster, V.; Chesebro, J.H.

    1984-05-31

    Forty patients with Type I membranoproliferative glomerulonephritis were treated for one year with dipyridamole, 225 mg per day, and aspirin, 975 mg per day, in a prospective, randomized, double-blind, placebo-controlled study. At the base line, the half-life of /sup 51/Cr-labeled platelets was reduced in 12 of 17 patients. The platelet half-life became longer and renal function stabilized in the treated group, as compared with the placebo group, suggesting a relation between platelet consumption and the glomerulopathy. The glomerular filtration rate, determined by iothalamate clearance, was better maintained in the treated group (average decrease, 1.3 ml per minute per 1.73 m/sup 2/ of body-surface area per 12 months) than in the placebo group (average decrease, 19.6). Fewer patients in the treated group than in the placebo group had progression to end-stage renal disease (3 of 21 after 62 months as compared with 9 of 19 after 33 months). The data suggest that dipyridamole and aspirin slowed the deterioration of renal function and the development of end-stage renal disease.

  11. A Prospective Study of the Clinical Profile, Outcome and Evaluation of D-dimer in Cerebral Venous Thrombosis

    PubMed Central

    Dharanipragada, Subrahmanyam; Basu, Debdatta; Ananthakrishnan, Ramesh; Surendiran, Deepanjali

    2016-01-01

    Introduction Cerebral Venous Thrombosis (CVT) is a well known disease with diverse clinical presentation and causes. With advances in neuroimaging and changing lifestyles, the clinical profile and causes of CVT are changing. D-dimer has been studied in early diagnosis of CVT with variable results. This prospective study was carried out to assess the clinical profile of CVT and role of D-dimer in diagnosis of CVT. Aim To study various aspects of CVT and role of D-dimer. Materials and Methods The study period was September 2012 to July 2014 and included 80 imaging proven patients of CVT. We also included 39 controls for assessing D-dimer. Data was collected according to a preformed format. D-dimer was assessed by a rapid semi-quantitative latex agglutination assay. Discharged patients were followed up to six months. Results Of the total 44 were women and 36 were men (F: M=1.2:1). The mean age of the patients was 29.5±9.68 years. Most common clinical features were headache 77 (96.25%), papilloedema (67.5%) and seizures 51 (63.75%). Pregnancy was the most common cause of CVT. Superior sagittal and transverse sinuses were the most common sinuses to be affected. The sensitivity and specificity of D-dimer for diagnosing CVT was 84.62% and 80% respectively. The risk factors for poor prognosis were altered sensorium, presence of sepsis, increased sinus involvement and deep sinus thrombosis. Conclusion CVT affects both sexes equally. Puerperium still contributes to majority of the cases. Iron deficiency anaemia needs to be evaluated as a contributing factor for incidence of CVT. D-dimer is not useful in puerperal female with CVT. Positive D-dimer will strengthen the suspicion of CVT in patients with acute headache followed by a neurological deficit. PMID:27504325

  12. Prospective Evaluation to Establish a Dose Response for Clinical Oral Mucositis in Patients Undergoing Head-and-Neck Conformal Radiotherapy

    SciTech Connect

    Narayan, Samir Lehmann, Joerg; Coleman, Matthew A.; Vaughan, Andrew; Yang, Claus Chunli; Enepekides, Danny; Farwell, Gregory; Purdy, James A.; Laredo, Grace; Nolan, Kerry A.S.; Pearson, Francesca S.; Vijayakumar, Srinivasan

    2008-11-01

    Purpose: We conducted a clinical study to correlate oral cavity dose with clinical mucositis, perform in vivo dosimetry, and determine the feasibility of obtaining buccal mucosal cell samples in patients undergoing head-and-neck radiation therapy. The main objective is to establish a quantitative dose response for clinical oral mucositis. Methods and Materials: Twelve patients undergoing radiation therapy for head-and-neck cancer were prospectively studied. Four points were chosen in separate quadrants of the oral cavity. Calculated dose distributions were generated by using AcQPlan and Eclipse treatment planning systems. MOSFET dosimeters were used to measure dose at each sampled point. Each patient underwent buccal sampling for future RNA analysis before and after the first radiation treatment at the four selected points. Clinical and functional mucositis were assessed weekly according to National Cancer Institute Common Toxicity Criteria, Version 3. Results: Maximum and average doses for sampled sites ranged from 7.4-62.3 and 3.0-54.3 Gy, respectively. A cumulative point dose of 39.1 Gy resulted in mucositis for 3 weeks or longer. Mild severity (Grade {<=} 1) and short duration ({<=}1 week) of mucositis were found at cumulative point doses less than 32 Gy. Polymerase chain reaction consistently was able to detect basal levels of two known radiation responsive genes. Conclusions: In our sample, cumulative doses to the oral cavity of less than 32 Gy were associated with minimal acute mucositis. A dose greater than 39 Gy was associated with longer duration of mucositis. Our technique for sampling buccal mucosa yielded sufficient cells for RNA analysis using polymerase chain reaction.

  13. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... minimal risk but presenting the prospect of direct benefit to individual subjects. 50.52 Section 50.52... investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual... prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely...

  14. MALDI-TOF MS in clinical parasitology: applications, constraints and prospects.

    PubMed

    Singhal, Neelja; Kumar, Manish; Virdi, Jugsharan Singh

    2016-10-01

    Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is currently being used for rapid and reproducible identification of bacteria, viruses and fungi in clinical microbiological laboratories. However, some studies have also reported the use of MALDI-TOF MS for identification of parasites, like Leishmania, Giardia, Cryptosporidium, Entamoeba, ticks and fleas. The present review collates all the information available on the use of this technique for parasites, in an effort to assess its applicability and the constraints for identification/diagnosis of parasites and diseases caused by them. Though MALDI-TOF MS-based identification of parasites is currently done by reference laboratories only, in future, this promising technology might surely replace/augment molecular methods in clinical parasitology laboratories. PMID:27387025

  15. MALDI-TOF MS in clinical parasitology: applications, constraints and prospects.

    PubMed

    Singhal, Neelja; Kumar, Manish; Virdi, Jugsharan Singh

    2016-10-01

    Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is currently being used for rapid and reproducible identification of bacteria, viruses and fungi in clinical microbiological laboratories. However, some studies have also reported the use of MALDI-TOF MS for identification of parasites, like Leishmania, Giardia, Cryptosporidium, Entamoeba, ticks and fleas. The present review collates all the information available on the use of this technique for parasites, in an effort to assess its applicability and the constraints for identification/diagnosis of parasites and diseases caused by them. Though MALDI-TOF MS-based identification of parasites is currently done by reference laboratories only, in future, this promising technology might surely replace/augment molecular methods in clinical parasitology laboratories.

  16. Mechanisms and clinical prospects of Notch inhibitors in the therapy of hematological malignancies

    PubMed Central

    Nefedova, Yulia; Gabrilovich, Dmitry

    2009-01-01

    Activation of Notch signaling has been implicated in pathogenesis of various hematologic tumors including leukemias, lymphomas, and multiple myeloma. Pre-clinical studies have suggested that inhibition of Notch could be an attractive new approach to treatment of hematologic malignancies. This review discusses most recent findings in the field and potential role of Notch signaling as a therapeutic target focusing on the effects of γ-secretase inhibitors. PMID:18951834

  17. Trabecular bone score (TBS): available knowledge, clinical relevance, and future prospects.

    PubMed

    Bousson, V; Bergot, C; Sutter, B; Levitz, P; Cortet, B

    2012-05-01

    The diagnosis of osteoporosis rests on areal bone mineral density (BMD) measurement using DXA. Cancellous bone microarchitecture is a key determinant of bone strength but cannot be measured using DXA. To meet the need for a clinical tool capable of assessing bone microarchitecture, the TBS was developed. The TBS is a texture parameter that evaluates pixel gray-level variations in DXA images of the lumbar spine. The TBS variations may reflect bone microarchitecture. We explain the general principles used to compute the TBS, and we report the correlations between TBS and microarchitectural parameters. Several limitations of the TBS as it is used now are pointed out. We discuss data from currently available clinical studies on the ability of the TBS to identify patients with fractures and to evaluate the fracture risk. We conclude that this new index emphasizes the failure of the BMD T-score to fully capture the fragility fracture risk. However, although microarchitecture may influence the TBS, today, to the best of our understanding, there is no sufficient evidence that a TBS measurement provides reliable information on the status of the bone microarchitecture for a given patient. The TBS depends on gray-level variations and in a projectional image obtained in vivo, these variations can have many causes. Nevertheless, as clinical studies suggest that the TBS predicts the risk of fracture even after adjustment for BMD, we are encouraged to learn more about this score. Additional studies will have to be performed to assess the advantages and limitations of the TBS, in order to ensure that it is used appropriately in clinical practice.

  18. Nutritional status and clinical outcome of children on continuous renal replacement therapy: a prospective observational study

    PubMed Central

    2012-01-01

    Background No studies on continuous renal replacement therapy (CRRT) have analyzed nutritional status in children. The objective of this study was to assess the association between mortality and nutritional status of children receiving CRRT. Methods Prospective observational study to analyze the nutritional status of children receiving CRRT and its association with mortality. The variables recorded were age, weight, sex, diagnosis, albumin, creatinine, urea, uric acid, severity of illness scores, CRRT-related complications, duration of admission to the pediatric intensive care unit, and mortality. Results The sample comprised 174 critically ill children on CRRT. The median weight of the patients was 10 kg, 35% were under percentile (P) 3, and 56% had a weight/P50 ratio of less than 0.85. Only two patients were above P95. The mean age for patients under P3 was significantly lower than that of the other patients (p = 0.03). The incidence of weight under P3 was greater in younger children (p = 0.007) and in cardiac patients and in those who had previous chronic renal insufficiency (p = 0.047). The mortality analysis did not include patients with pre-existing renal disease. Mortality was 38.9%. Mortality for patients with weight < P3 was greater than that of children with weight > P3 (51% vs 33%; p = 0.037). In the univariate and multivariate logistic regression analyses, the only factor associated with mortality was protein-energy wasting (malnutrition) (OR, 2.11; 95% CI, 1.067-4.173; p = 0.032). Conclusions The frequency of protein-energy wasting in children who require CRRT is high, and the frequency of obesity is low. Protein-energy wasting is more frequent in children with previous end-stage renal disease and heart disease. Underweight children present a higher mortality rate than patients with normal body weight. PMID:23016957

  19. Environmental and clinical epidemiology of Aspergillus terreus: data from a prospective surveillance study.

    PubMed

    Rüping, M J G T; Gerlach, S; Fischer, G; Lass-Flörl, C; Hellmich, M; Vehreschild, J J; Cornely, O A

    2011-07-01

    Aspergillus terreus may be resistant to amphotericin B and is associated with significant morbidity and mortality in immunocompromised patients. Local incidence is influenced by the density of airborne Aspergillus spp. spores which may in turn depend on meteorological factors. Once-weekly environmental samples were collected prospectively inside and outside the University Hospital of Cologne, Germany (UHC) and haematological patients were screened for nasal Aspergillus spp. colonisation and monitored for invasive fungal disease (IFD). RAPD (rapid amplification of polymorphic DNA)-polymerase chain reaction (PCR) and amphotericin B susceptibility testing were performed on all A. terreus isolates. A total of 4919 colony-forming units (cfu) were isolated (2212 indoors, 2707 outdoors). Further identification revealed A. fumigatus (73.5%), A. niger (4.3%), A. flavus (1.7%), A. terreus (0.2%) and non-Aspergillus fungi (20.3%). RAPD-PCR did not reveal clonal relationships between the A. terreus isolates. All A. terreus isolates displayed complete resistance to amphotericin. The B. Aspergillus spp. conidia exposure was lowest in June and highest in November inside and outside UHC. Conidia load correlated with the season and the relative humidity, with increasing spore counts during dry periods. One out of 855 nasal swabs was positive for A. niger. The patient did not develop IFD. A. terreus is unlikely to be a relevant pathogen at the UHC. Results from RAPD-PCR suggested a wide epidemiological variety of strains rather than a common source of contamination. Nasal swab surveillance cultures for early detection of Aspergillus spp. colonisation were not useful in identifying patients who may develop IFD. The risk of IFD at the UHC may increase in autumn and during dry periods.

  20. Physician exposure to ionizing radiation during trauma resuscitation: A prospective clinical study

    SciTech Connect

    Weiss, E.L.; Singer, C.M.; Benedict, S.H.; Baraff, L.J.

    1990-02-01

    A prospective study of emergency physician whole body and extremity exposure to ionizing radiation during trauma resuscitation over a three-month period was conducted. Radiation film badges and thermoluminescent dosimeter finger rings were permanently attached to leaded aprons worn by emergency medicine residents during all trauma resuscitations. One set of apron and finger ring dosimeters was designated for the resident who managed the airway and stabilized the neck, when necessary, during cervical spine radiography (A-CS resident). A separate set of dosimeters was designated for the resident supervising the resuscitation. During the study period, 150 major trauma patients requiring 481 radiographic studies were treated. The mean monthly cumulative whole body exposures were 136.7 +/- 85.0 and 103.3 +/- 60.3 mrem for A-CS and supervising residents, respectively. The mean weekly cumulative extremity exposures were 523.3 +/- 611.0 and 46.7 +/- 18.6 mrem for A-CS and supervising residents, respectively. Calculated whole body exposures per patient were 2.7 mrem for the A-CS resident and 2.1 mrem for the supervising resident. Calculated extremity exposures per patient were 41.9 +/- 48.9 and 3.7 +/- 1.5 mrem, respectively. To exceed the annual whole body exposure limit established by the National Council of Radiologic Protection, the A-CS resident, working 200 shifts per year, would have to treat 9.2 trauma patients per shift. To exceed the annual extremity exposure limit, the A-CS resident would have to treat 5.9 trauma patients per shift. Of note, European exposure limits are 10% of current US limits. We conclude that significant exposures may occur to physicians working in trauma centers and that the use of shielding devices is indicated.

  1. Factors Associated With Pelvic Fracture-Related Arterial Bleeding During Trauma Resuscitation: A Prospective Clinical Study

    PubMed Central

    Toth, Laszlo; King, Kate L.; McGrath, Benjamin

    2014-01-01

    Objectives: To determine predictors of pelvic fracture-related arterial bleeding (PFRAB) from the information available in the Emergency Department (ED). Design: Prospective cohort study. Setting: Single level-1 Trauma Center. Patients: In a 3-year period ending in December 2008, consecutive high-energy pelvic fracture patients older than 18 years were included. Patients who arrived >4 hours after injury or dead on arrival were excluded. Patient management followed advanced trauma life support and institutional guidelines. Collected data included patient demographics, mechanism of injury, vital signs, acid-base status, fluid resuscitation, trauma scores, fracture patterns, procedures, and outcomes. Potential predictors were identified using standard statistical tests: Univariate analysis, Pearson correlation (r), receiver operator characteristic, and decision tree analysis. Intervention: Observational study. Outcome Measures: PFRAB was determined based on angiography or computed tomography angiogram or laparotomy findings. Results: Of the 143 study patients, 15 (10%) had PFRAB. They were significantly older, more severely injured, more hypotensive, more acidotic, more likely to require transfusions in the ED, and had higher mortality rate than non-PFRAB patients. No single variable proved to be a strong predictor but some had a significant correlation with PFRAB. Useful predictors identified were worst base deficit (BD), receiver operator characteristic (0.77, cutoff: 6 mmol/L, r = 0.37), difference between any 2 measures of BD within 4 hours (ΔBD) >2 mmol/L, transfusion in ED (yes/no), and worst systolic blood pressure <104 mm Hg. Demographics, injury mechanism, fracture pattern, temperature, and pH had poor predictive value. Conclusions: BD <6 mmol/L, ΔBD >2 mmol/L, systolic blood pressure <104 mm Hg, and the need for transfusion in ED are independent predictors of PFRAB in the ED. These predictors can be valuable to triage blunt trauma victims for pelvic

  2. Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.

    PubMed

    Ehling, Rainer; Di Pauli, Franziska; Lackner, Peter; Rainer, Carolyn; Kraus, Viktoria; Hegen, Harald; Lutterotti, Andreas; Kuenz, Bettina; De Zordo, Tobias; Schocke, Michael; Glatzl, Susanne; Löscher, Wolfgang N; Deisenhammer, Florian; Reindl, Markus; Berger, Thomas

    2015-10-15

    Data from in vitro and animal studies support a neuroprotective role of glatiramer acetate (GA) in multiple sclerosis (MS). We investigated prospectively whether treatment with GA leads to clinical and paraclinical changes associated with neuroprotection in patients with relapsing-remitting (RR) MS. Primary aim of this clinical study was to determine serum BDNF levels in RR-MS patients who were started on GA as compared to patients who remained therapy-naive throughout 24 months. Secondary outcomes included relapses and EDSS, cognition, quality of life, fatigue and depression, BDNF expression levels on peripheral immune cells (FACS, RT-PCR), serum anti-myelin basic peptide (MBP) antibody status, evoked potential and cerebral MRI studies. While GA treatment did not alter serum levels or expression levels on peripheral immune cells of BDNF over time it resulted in a transient increase of serum IgG antibody response to MBP, mainly due to subtype IgG1 (p<0.05), after 3 months. However, no significant differences were found between GA treated and therapy-naive patients with regard to serum BDNF and intracellular BDNF expression levels, nerve conduction (including median and tibial nerve somatosensory, pattern-shift visual and upper and lower limb motor evoked potentials) or MRI (including volume of hyperintense lesions, volume of hypointense lesions after CE, mean diffusivity and fractional anisotropy) outcome parameters. In conclusion, our findings do not support a major impact of GA treatment on paraclinical markers of neuroprotection in human RR-MS.

  3. Clinical outcome of a two-piece implant system with an internal hexagonal connection: a prospective study.

    PubMed

    Andreasi Bassi, M; Lopez, M A; Confalone, L; Gaudio, R M; Lombardo, L; Lauritano, D

    2016-01-01

    The purpose of this prospective clinical study was to evaluate the survival rate (SVR - i.e. fixtures still in place at the end of the observation period) and success rate (SCR - i.e. bone resorption around implant neck) of an implant system characterized by cylindrical and tapered implants, both provided with an internal hexagonal connection. In the period between January 1996 and October 2011, 52 implants with internal hexagonal connection were inserted in 21 females and 31 males, mean age 54±11 years. The mean post-surgical follow-up was 44.6±34.4 months. Several parameters were evaluated as potential outcome conditioners: age, gender, smoking, replaced tooth, periodontal disease, fixture shape (i.e. cylindrical or tapered), jaw location (i.e. maxilla or mandible), bone graft, immediate loading, post-extractive placement, type of prosthesis (i.e. single crown or bridge), edentulism, implant diameter and length. An SPSS statistical program was used and Cox regression analysis performed. SVR was 100% since no fixtures were lost. SCR, expressed through the mean marginal bone loss, was 77%. No significant differences were found, for most of the parameters analyzed, with the exception of prosthetic bridges, where implants supporting this type of rehabilitation showed a worse clinical outcome in comparison to single crown rehabilitations. Internal hexagonal connection is a reliable tool for oral rehabilitation. PMID:27469542

  4. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

    PubMed Central

    Dal-Ré, R; Espada, J; Ortega, R

    1999-01-01

    OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. PMID:10390685

  5. Comparative Outcomes of the Two Types of Sacral Extradural Spinal Meningeal Cysts Using Different Operation Methods: A Prospective Clinical Study

    PubMed Central

    Sun, Jian-jun; Wang, Zhen-yu; Teo, Mario; Li, Zhen-dong; Wu, Hai-bo; Yen, Ru-yu; Zheng, Mei; Chang, Qing; Yisha Liu, Isabelle

    2013-01-01

    This prospective study compares different clinical characteristics and outcomes of patients with two types of sacral extradural spinal meningeal cysts (SESMC) undergoing different means of surgical excision. Using the relationship between the cysts and spinal nerve roots fibers (SNRF) as seen under microscope, SESMCs were divided into two types: cysts with SNRF known as Tarlov cysts and cysts without. The surgical methods were tailored to the different types of SESMCs. The improved Japanese Orthopedic Association (IJOA) scoring system was used to evaluate preoperative and postoperative neurological function of the patients. Preoperative IJOA scores were 18.5±1.73, and postoperative IJOA scores were 19.6±0.78. The difference between preoperative and postoperative IJOA scores was statistically significant (t = -4.52, p = 0.0001), with a significant improvement in neurological function after surgery. Among the improvements in neurological functions, the most significant was sensation (z=-2.74, p=0.006), followed by bowel/bladder function (z=-2.50, p=0.01). There was a statistically significant association between the types of SESMC and the number (F=12.57, p=0.001) and maximum diameter (F=8.08, p=0.006) of the cysts. SESMC with SNRF are often multiple and small, while cysts without SNRF tend to be solitary and large. We advocate early surgical intervention for symptomatic SESMCs in view of significant clinical improvement postoperatively. PMID:24386317

  6. The clinical utility of genetic testing in breast cancer kindreds: a prospective study in families without a demonstrable BRCA mutation.

    PubMed

    Møller, Pål; Stormorken, Astrid; Holmen, Marit Muri; Hagen, Anne Irene; Vabø, Anita; Mæhle, Lovise

    2014-04-01

    We report prospectively observed risk for breast cancer in breast cancer kindreds without a demonstrable BRCA1/2 mutation. According to family history, the optimal available member(s) of each breast cancer kindred attending our clinic was tested for BRCA mutations. Women in families without a demonstrable BRCA mutation were subjected to annual mammography. BRCA mutations were demonstrated in 496/2,118 (23 %) breast cancer kindreds. In families without a demonstrable BRCA mutation, a total of 3,161 healthy women aged 25-59 years were prospectively followed for 24,808 observation years. Sixty-four cancers were observed, compared to 34.0 expected (p < 0.01), arriving at a 7.9 % cumulative risk at age 60 compared to 4.0 % in the population [relative risk (RR) = 2.0]. Women with one mother or sister affected ≤50 years and with no other close relatives with breast cancer did not have increased risk (0 cancers observed and 0.6 expected at age 40, 11 cancers observed and 7.9 expected at age 60, p > 0.05). Excluding these, cumulative risk at 60 years was 8.8 % (RR = 2.2). The highest cumulative risk at 60 years was 11.4 %, found in families with two cases ≤55 years (RR = 2.8). In breast cancer kindreds without a demonstrable BRCA mutation, the risk for breast cancer in female first degree relatives was about twice the risk in the general population. Women with one early affected relative only did not have increased risk for early onset breast cancer, while those with more than one young affected relative had close to three times population risk.

  7. Drug use in relation to clinical activities as an instrument for prospective drug budgeting. The Belgian experience.

    PubMed

    Closon, M C; Crott, R; Even-Adin, D

    1996-03-01

    In an effort to control escalating health expenditures, especially in hospitals, many countries are planning or experimenting with prospective budgeting systems. Belgium is no exception and has recently introduced, with some success, limited fixed charges per hospital admission and/or per hospitalisation day for laboratory tests and radiographic investigations. More recently, the focus has shifted to hospital drug expenditures, which have shown high growth rates over the past few years. Until now, such expenditures have been reimbursed on a fee-for-service system, often with limited out-of-pocket charges for hospitalised patients. In order to curb the growth of drug expenditures, it is appropriate to investigate whether the financing of hospital drugs through a prospective budgeting system could be a feasible solution. Therefore, we constructed a database of over 270 000 admissions from a sample of 23 Belgian general and teaching (university) hospitals for the year 1991. Data were obtained from the official Minimum Basic Data Set or Résumé Clinique Minimum, which contains summarised clinical and administrative information, plus detailed expenditures (including medications) for each hospital stay. This information allowed us to categorize each stay into an appropriate diagnosis-related group (DRG). Our first descriptive analysis identified a number of major variables that influenced patients' drug expenditures: all-patient DRG (APDRG), age, disease severity, length of stay in an intensive care unit, emergency admission, death during hospitalisation, and hospital type (teaching or general). A covariance analysis was then performed on all hospital stays combined, and separately on surgical and medical stays. The results indicated that these variables taken together account for between 56.5 and 76.3% of drug expenditures in medical and surgical stays, respectively, with the major variance explained by differences in APDRG category. However, when the data were

  8. Patient punctuality and clinic performance: observations from an academic-based private practice pain centre: a prospective quality improvement study

    PubMed Central

    Williams, Kayode A; Chambers, Chester G; Dada, Maqbool; McLeod, Julia C; Ulatowski, John A

    2014-01-01

    Objectives The aim of this study was to examine the effects of an intervention to alter patient unpunctuality. The major hypothesis was that the intervention will change the distribution of patient unpunctuality by decreasing patient tardiness and increasing patient earliness. Design Prospective Quality Improvement. Setting Specialty Pain Clinic in suburban Baltimore, Maryland, USA. Participants The patient population ranged in age from 18 to 93 years. All patients presenting to the clinic during the study period were included in the study. The average monthly volume was 86.2 (SD=13) patients. A total of 1500 patient visits were included in this study. Interventions We tracked appointment times and patient arrival times at an ambulatory pain clinic. An intervention was made in which patients were informed that tardy patients would not be seen and would be rescheduled. This policy was enforced over a 12-month period. Primary and secondary outcome measures The distribution of patient unpunctuality was developed preintervention and at 12 months after implementation. Distribution parameters were used as inputs to a discrete event simulation to determine effects of the change in patient unpunctuality on clinic delay. Results Data regarding patient unpunctuality were gathered by direct observation before and after implementation of the intervention. The mean unpunctuality changed from −20.5 min (110 observations, SD=1.7) preintervention to −23.2 (169, 1.2) at 1 month after the intervention, −23.8 min (69, 1.8) at 6 months and −25.0 min (71, 1.2) after 1 year. The unpunctuality 12 months after initiation of the intervention was significantly different from that prior to the intervention (p<0.05). Conclusions Physicians and staff are able to alter patient arrival patterns to reduce patient unpunctuality. Reducing tardiness improves some measures of clinic performance, but may not always improve waiting times. Accommodating early arriving patients

  9. Oropharyngeal dysphagia, free water protocol and quality of life: an update from a prospective clinical trial.

    PubMed

    Karagiannis, Martha; Karagiannis, Tom C

    2014-01-01

    Oropharyngeal dysphagia, typically associated with older adults, represents a spectrum of swallowing disorders with potentially serious complications and a negative impact on quality of life. A major complication of dysphagia is caused by aspiration, predominantly of thin liquids, which may cause aspiration pneumonia. Given that thin liquids are typically aspirated, the conventional therapy involves altering the diet to one consisting of modified solid consistencies and thickened fluids. While it is well known that this approach is appropriate for aspiration, it does represent difficulties with compliancy and quality of life. We have undertaken a relatively large scale clinical trial to investigate the relationships between the effects of free access to water and the development of aspiration, aspects of hydration and issues related to quality in people with dysphagia. Along with clinical observations and findings from others we have previously stratified people with dysphagia, namely those that are immobile or who have low mobility and severe degenerative neurological dysfunction, at highest risk of developing aspiration pneumonia following intake of water. In the present study, we have extended our previous clinical results. Our findings indicate that following purposeful selection of people with dysphagia with their own mobility and relatively healthy cognitive function, free access to water did not result in aspiration pneumonia, improved measures of hydration and in particular, significantly increased quality of life when compared to a diet consisting of thickened fluids only. Overall, we conclude that in people with good mobility and cognitive ability, there is no need to deviate from the Frazier Rehabilitation Centre free water protocol, which allows for the provision of water to people with dysphagia with strict guidelines particularly in relation to good physical ability.

  10. Complex regional pain syndrome: evidence for warm and cold subtypes in a large prospective clinical sample.

    PubMed

    Bruehl, Stephen; Maihöfner, Christian; Stanton-Hicks, Michael; Perez, Roberto S G M; Vatine, Jean-Jacques; Brunner, Florian; Birklein, Frank; Schlereth, Tanja; Mackey, Sean; Mailis-Gagnon, Angela; Livshitz, Anatoly; Harden, R Norman

    2016-08-01

    Limited research suggests that there may be Warm complex regional pain syndrome (CRPS) and Cold CRPS subtypes, with inflammatory mechanisms contributing most strongly to the former. This study for the first time used an unbiased statistical pattern recognition technique to evaluate whether distinct Warm vs Cold CRPS subtypes can be discerned in the clinical population. An international, multisite study was conducted using standardized procedures to evaluate signs and symptoms in 152 patients with clinical CRPS at baseline, with 3-month follow-up evaluations in 112 of these patients. Two-step cluster analysis using automated cluster selection identified a 2-cluster solution as optimal. Results revealed a Warm CRPS patient cluster characterized by a warm, red, edematous, and sweaty extremity and a Cold CRPS patient cluster characterized by a cold, blue, and less edematous extremity. Median pain duration was significantly (P < 0.001) shorter in the Warm CRPS (4.7 months) than in the Cold CRPS subtype (20 months), with pain intensity comparable. A derived total inflammatory score was significantly (P < 0.001) elevated in the Warm CRPS group (compared with Cold CRPS) at baseline but diminished significantly (P < 0.001) over the follow-up period, whereas this score did not diminish in the Cold CRPS group (time × subtype interaction: P < 0.001). Results support the existence of a Warm CRPS subtype common in patients with acute (<6 months) CRPS and a relatively distinct Cold CRPS subtype most common in chronic CRPS. The pattern of clinical features suggests that inflammatory mechanisms contribute most prominently to the Warm CRPS subtype but that these mechanisms diminish substantially during the first year postinjury. PMID:27023422

  11. Biopsychosocial influence on shoulder pain: risk subgroups translated across preclinical and clinical prospective cohorts.

    PubMed

    George, Steven Z; Wallace, Margaret R; Wu, Samuel S; Moser, Michael W; Wright, Thomas W; Farmer, Kevin W; Borsa, Paul A; Parr, Jeffrey J; Greenfield, Warren H; Dai, Yunfeng; Li, Hua; Fillingim, Roger B

    2015-01-01

    Tailored treatment based on individual risk factors is an area with promise to improve options for pain relief. Musculoskeletal pain has a biopsychosocial nature, and multiple factors should be considered when determining risk for chronic pain. This study investigated whether subgroups comprised genetic and psychological factors predicted outcomes in preclinical and clinical models of shoulder pain. Classification and regression tree analysis was performed for an exercise-induced shoulder injury cohort (n = 190) to identify high-risk subgroups, and a surgical pain cohort (n = 150) was used for risk validation. Questionnaires for fear of pain and pain catastrophizing were administered before injury and preoperatively. DNA collected from saliva was genotyped for a priori selected genes involved with pain modulation (COMT and AVPR1A) and inflammation (IL1B and TNF/LTA). Recovery was operationalized as a brief pain inventory rating of 0/10 for current pain intensity and <2/10 for worst pain intensity. Follow-up for the preclinical cohort was in daily increments, whereas follow-up for the clinical cohort was at 3, 6, and 12 months postoperatively. Risk subgroups comprised the COMT high pain sensitivity variant and either pain catastrophizing or fear of pain were predictive of heightened shoulder pain responses in the preclinical model. Further analysis in the clinical model identified the COMT high pain sensitivity variant and pain catastrophizing subgroup as the better predictor. Future studies will determine whether these findings can be replicated in other anatomical regions and whether personalized medicine strategies can be developed for this risk subgroup. PMID:25599310

  12. Considering Cost-Effectiveness in Cardiology Clinical Guidelines: Progress and Prospects.

    PubMed

    Hlatky, Mark A

    2016-01-01

    Since the 1980s, when the American College of Cardiology (ACC) and the American Heart Association (AHA) established a joint task force to examine the use of cardiovascular procedures and therapies, cardiologists have been leaders in the development of clinical practice guidelines. The ACC/AHA guidelines development process has evolved considerably over the last 30 or more years. Guidelines now focus on clinical conditions, such as angina, instead of procedures, such as bypass surgery. There is a formal organizational structure, with dedicated staff, a standing committee on practice guidelines, and specific panels of volunteer experts on each topic. This process tightly manages conflicts of interest and strives for evidence-based, as opposed to opinion-based, guidelines, with a clear citation of the supporting evidence. Traditional clinical guidelines consider only what is best for the individual patient, and have explicitly not considered the cost to society. Nevertheless, in many guidelines development meetings, high cost was implicitly considered: if a procedure was extremely costly, the evidence needed to be very strong. The Guidelines Committee recognized that cost considerations ought to be made more transparent, and that the evidence on economic value should be explicitly cited when available. These considerations were formalized by a recent white paper on incorporating economic considerations into ACC/AHA guidelines. In considering value, it is necessary to assess the quality of the evidence as well as to define levels of value. The next ACC/AHA guideline will incorporate value as a part of its recommendations. This will be an evidence-based process in which published economic assessments relating to key questions will be reviewed.

  13. Applying Automated MR-Based Diagnostic Methods to the Memory Clinic: A Prospective Study.

    PubMed

    Klöppel, Stefan; Peter, Jessica; Ludl, Anna; Pilatus, Anne; Maier, Sabrina; Mader, Irina; Heimbach, Bernhard; Frings, Lars; Egger, Karl; Dukart, Juergen; Schroeter, Matthias L; Perneczky, Robert; Häussermann, Peter; Vach, Werner; Urbach, Horst; Teipel, Stefan; Hüll, Michael; Abdulkadir, Ahmed

    2015-01-01

    Several studies have demonstrated that fully automated pattern recognition methods applied to structural magnetic resonance imaging (MRI) aid in the diagnosis of dementia, but these conclusions are based on highly preselected samples that significantly differ from that seen in a dementia clinic. At a single dementia clinic, we evaluated the ability of a linear support vector machine trained with completely unrelated data to differentiate between Alzheimer's disease (AD), frontotemporal dementia (FTD), Lewy body dementia, and healthy aging based on 3D-T1 weighted MRI data sets. Furthermore, we predicted progression to AD in subjects with mild cognitive impairment (MCI) at baseline and automatically quantified white matter hyperintensities from FLAIR-images. Separating additionally recruited healthy elderly from those with dementia was accurate with an area under the curve (AUC) of 0.97 (according to Fig. 4). Multi-class separation of patients with either AD or FTD from other included groups was good on the training set (AUC >  0.9) but substantially less accurate (AUC = 0.76 for AD, AUC = 0.78 for FTD) on 134 cases from the local clinic. Longitudinal data from 28 cases with MCI at baseline and appropriate follow-up data were available. The computer tool discriminated progressive from stable MCI with AUC = 0.73, compared to AUC = 0.80 for the training set. A relatively low accuracy by clinicians (AUC = 0.81) illustrates the difficulties of predicting conversion in this heterogeneous cohort. This first application of a MRI-based pattern recognition method to a routine sample demonstrates feasibility, but also illustrates that automated multi-class differential diagnoses have to be the focus of future methodological developments and application studies.

  14. Applying Automated MR-Based Diagnostic Methods to the Memory Clinic: A Prospective Study.

    PubMed

    Klöppel, Stefan; Peter, Jessica; Ludl, Anna; Pilatus, Anne; Maier, Sabrina; Mader, Irina; Heimbach, Bernhard; Frings, Lars; Egger, Karl; Dukart, Juergen; Schroeter, Matthias L; Perneczky, Robert; Häussermann, Peter; Vach, Werner; Urbach, Horst; Teipel, Stefan; Hüll, Michael; Abdulkadir, Ahmed

    2015-01-01

    Several studies have demonstrated that fully automated pattern recognition methods applied to structural magnetic resonance imaging (MRI) aid in the diagnosis of dementia, but these conclusions are based on highly preselected samples that significantly differ from that seen in a dementia clinic. At a single dementia clinic, we evaluated the ability of a linear support vector machine trained with completely unrelated data to differentiate between Alzheimer's disease (AD), frontotemporal dementia (FTD), Lewy body dementia, and healthy aging based on 3D-T1 weighted MRI data sets. Furthermore, we predicted progression to AD in subjects with mild cognitive impairment (MCI) at baseline and automatically quantified white matter hyperintensities from FLAIR-images. Separating additionally recruited healthy elderly from those with dementia was accurate with an area under the curve (AUC) of 0.97 (according to Fig. 4). Multi-class separation of patients with either AD or FTD from other included groups was good on the training set (AUC >  0.9) but substantially less accurate (AUC = 0.76 for AD, AUC = 0.78 for FTD) on 134 cases from the local clinic. Longitudinal data from 28 cases with MCI at baseline and appropriate follow-up data were available. The computer tool discriminated progressive from stable MCI with AUC = 0.73, compared to AUC = 0.80 for the training set. A relatively low accuracy by clinicians (AUC = 0.81) illustrates the difficulties of predicting conversion in this heterogeneous cohort. This first application of a MRI-based pattern recognition method to a routine sample demonstrates feasibility, but also illustrates that automated multi-class differential diagnoses have to be the focus of future methodological developments and application studies. PMID:26401773

  15. Duhuo Jisheng Tang for treating osteoarthritis of the knee: a prospective clinical observation

    PubMed Central

    Lai, Jung-Nien; Chen, Huey-Jeng; Chen, Chao-Chung; Lin, Jer-Huei; Hwang, Jing-Shiang; Wang, Jung-Der

    2007-01-01

    Background Little scientific evidence supports the efficacy of herbal medicines in the treatment of degenerative arthritis of the knee. The purpose of this study is to evaluate both the efficacy and safety of a finished Chinese herbal preparation Duhuo Jisheng Tang (DJT) in reducing symptoms of degenerative osteoarthritis of the knee. Methods A prospective follow-up study was carried out in two hospitals in Taipei between April and October 2005. Sixty-eight osteoarthritis patients, with symptoms diagnosed by radiologists, received DJT at a rate of 2.5 g, twice daily for four weeks. Baseline scores were measured on the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, followed by further measures at the end of weeks 1, 2 and 4. The World Health Organization Quality of Life (WHOQOL) assessment was undertaken as a secondary outcome, with pattern identification questionnaires being adopted. Regression models were constructed to explore the score differences between the baseline and at weeks 2 and 4 by various determinants including age, gender, body mass index (BMI), severity at baseline, use of rescue medication, aversion to cold and flaccidity of the lower back and knees. Results Among the 68 participants, there were statistically significant reductions in the WOMAC index scores for pain, stiffness and physical functioning in the second and fourth weeks, with effects first appearing during week 2. By week 4, the mean WOMAC index scores had fallen from 22.2 (± 19.2) to 16.1 (± 16.2) for pain, from 28.1 (± 24.9) to 18.5 (± 20.3) for stiffness, and from 22.6 (± 18.0) to 18.2 (± 17.8) for physical functioning, while the global score for pain under the visual analogue scale (VAS) was reduced from 38.7 (± 21.5) to 27.8 (± 19.8). Conclusion In the treatment of degenerative osteoarthritis of the knee, a 4-week therapy with the Chinese herbal preparation DJT reduced pain and stiffness and improved physical functioning, but it was less effective

  16. Computerized tomographic simulation compared with clinical mark-up in palliative radiotherapy: A prospective study

    SciTech Connect

    Haddad, Peiman; Cheung, Fred; Pond, Gregory; Easton, Debbie; Cops, Frederick; Bezjak, Andrea; McLean, Michael; Levin, Wilfred; Billingsley, Susan; Williams, Diane; Wong, Rebecca . E-mail: Rebecca.Wong@rmp.uhn.on.ca

    2006-07-01

    Purpose To evaluate the impact of computed tomographic (CT) planning in comparison to clinical mark-up (CM) for palliative radiation of chest wall metastases. Methods and Materials In patients treated with CM for chest wall bone metastases (without conventional simulation/fluoroscopy), two consecutive planning CT scans were acquired with and without an external marker to delineate the CM treatment field. The two sets of scans were fused for evaluation of clinical tumor volume (CTV) coverage by the CM technique. Under-coverage was defined as the proportion of CTV not covered by the CM 80% isodose. Results Twenty-one treatments (ribs 17, sternum 2, and scapula 2) formed the basis of our study. Due to technical reasons, comparable data between CM and CT plans were available for 19 treatments only. CM resulted in a mean CTV under-coverage of 36%. Eleven sites (58%) had an under-coverage of >20%. Mean volume of normal tissues receiving {>=}80% of the dose was 5.4% in CM and 9.3% in CT plans (p = 0.017). Based on dose-volume histogram comparisons, CT planning resulted in a change of treatment technique from direct apposition to a tangential pair in 7 of 19 cases. Conclusions CT planning demonstrated a 36% under-coverage of CTV with CM of ribs and chest wall metastases.

  17. A Prospective Study of Clinical Outcomes Related to Third Molar Removal or Retention

    PubMed Central

    Cunha-Cruz, Joana; Rothen, Marilynn; Spiekerman, Charles; Drangsholt, Mark; Anderson, Loren; Roset, Gayle A.

    2014-01-01

    Objectives. We investigated outcomes of third molar removal or retention in adolescents and young adults. Methods. We recruited patients aged 16 to 22 years from a dental practice–based research network in the Pacific Northwest from May 2009 through September 2010 who had at least 1 third molar present and had never undergone third molar removal. Data were acquired via questionnaire and clinical examination at baseline, periodic online questionnaires, and clinical examination at 24 months. Results. A total of 801 patients participated. Among patients undergoing third molar removal, rates of paresthesia and jaw joint symptoms lasting more than 1 month were 6.3 and 34.3 per 100 person-years, respectively. Among patients not undergoing removal, corresponding rates were 0.7 and 8.8. Periodontal attachment loss at distal sites of second molars did not significantly differ by third molar removal status. Incident caries at the distal surfaces of second molars occurred in fewer than 1% of all sites. Conclusions. Rates of paresthesia and temporomandibular joint disorder were higher after third molar removal. Periodontal attachment loss and incident caries at the distal sites of second molars were not affected by extraction status. PMID:24524521

  18. Pharmacological Chaperone Therapy: Preclinical Development, Clinical Translation, and Prospects for the Treatment of Lysosomal Storage Disorders

    PubMed Central

    Parenti, Giancarlo; Andria, Generoso; Valenzano, Kenneth J

    2015-01-01

    Lysosomal storage disorders (LSDs) are a group of inborn metabolic diseases caused by mutations in genes that encode proteins involved in different lysosomal functions, in most instances acidic hydrolases. Different therapeutic approaches have been developed to treat these disorders. Pharmacological chaperone therapy (PCT) is an emerging approach based on small-molecule ligands that selectively bind and stabilize mutant enzymes, increase their cellular levels, and improve lysosomal trafficking and activity. Compared to other approaches, PCT shows advantages, particularly in terms of oral administration, broad biodistribution, and positive impact on patients' quality of life. After preclinical in vitro and in vivo studies, PCT is now being translated in the first clinical trials, either as monotherapy or in combination with enzyme replacement therapy, for some of the most prevalent LSDs. For some LSDs, the results of the first clinical trials are encouraging and warrant further development. Future research in the field of PCT will be directed toward the identification of novel chaperones, including new allosteric drugs, and the exploitation of synergies between chaperone treatment and other therapeutic approaches. PMID:25881001

  19. Analysis of Cancer Metabolism by Imaging Hyperpolarized Nuclei: Prospects for Translation to Clinical Research

    PubMed Central

    Kurhanewicz, John; Vigneron, Daniel B; Brindle, Kevin; Chekmenev, Eduard Y; Comment, Arnaud; Cunningham, Charles H; DeBerardinis, Ralph J; Green, Gary G; Leach, Martin O; Rajan, Sunder S; Rizi, Rahim R; Ross, Brian D; Warren, Warren S; Malloy, Craig R

    2011-01-01

    A major challenge in cancer biology is to monitor and understand cancer metabolism in vivo with the goal of improved diagnosis and perhaps therapy. Because of the complexity of biochemical pathways, tracer methods are required for detecting specific enzyme-catalyzed reactions. Stable isotopes such as 13C or 15N with detection by nuclear magnetic resonance provide the necessary information about tissue biochemistry, but the crucial metabolites are present in low concentration and therefore are beyond the detection threshold of traditional magnetic resonance methods. A solution is to improve sensitivity by a factor of 10,000 or more by temporarily redistributing the populations of nuclear spins in a magnetic field, a process termed hyperpolarization. Although this effect is short-lived, hyperpolarized molecules can be generated in an aqueous solution and infused in vivo where metabolism generates products that can be imaged. This discovery lifts the primary constraint on magnetic resonance imaging for monitoring metabolism—poor sensitivity—while preserving the advantage of biochemical information. The purpose of this report was to briefly summarize the known abnormalities in cancer metabolism, the value and limitations of current imaging methods for metabolism, and the principles of hyperpolarization. Recent preclinical applications are described. Hyperpolarization technology is still in its infancy, and current polarizer equipment and methods are suboptimal. Nevertheless, there are no fundamental barriers to rapid translation of this exciting technology to clinical research and perhaps clinical care. PMID:21403835

  20. Disc replacement using Pro-Disc C versus fusion: a prospective randomised and controlled radiographic and clinical study

    PubMed Central

    Ahlhelm, F.; Pitzen, T.; Steudel, W. I.; Jung, J.; Shariat, K.; Steimer, O.; Bachelier, F.; Pape, D.

    2006-01-01

    Anterior cervical discectomy and fusion (ACDF) may be considered to be the gold standard for treatment of symptomatic degenerative disc disease within the cervical spine. However, fusion of the segment may result in progressive degeneration of the adjacent segments. Therefore, dynamic stabilization procedures have been introduced. Among these, artificial disc replacement by disc prosthesis seems to be promising. However, to be so, segmental motion must be preserved. This, again, is very difficult to judge and has not yet been proven. The aim of the current study was to first analyse the segmental motion following artificial disc replacement using a disc prosthesis. A second aim was to compare both segmental motion as well as clinical result to the current gold standard (ACDF). This is a prospective controlled study. Twenty-five patients with cervical disc herniation were enrolled and assigned to either study group (receiving a disc prosthesis) or control group (receiving ACDF, using a cage with bone graft and an anterior plate.) Radiostereometric analysis was used to quantify intervertebral motion immediately as well as 3, 6, 12 and 24 weeks postoperatively. Further, clinical results were judged using visual analogue scale and neuro-examination. Cervical spine segmental motion decreased over time in the presence of disc prosthesis or ACDF. However, the loss of segmental motion is significantly higher in the ACDF group, when looked at 3, 6, 12 and 24 weeks after surgery. We observed significant pain reduction in neck and arm postoperatively, without significant difference between both groups (P > 0.05). Cervical spine disc prosthesis preserves cervical spine segmental motion within the first 6 months after surgery. The clinical results are the same when compared to the early results following ACDF. PMID:17106665

  1. Educational Level, Anticoagulation Quality, and Clinical Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Prospective Cohort Study.

    PubMed

    Hofmann, Eveline; Faller, Nicolas; Limacher, Andreas; Méan, Marie; Tritschler, Tobias; Rodondi, Nicolas; Aujesky, Drahomir

    2016-01-01

    Whether the level of education is associated with anticoagulation quality and clinical outcomes in patients with acute venous thromboembolism (VTE) is uncertain. We thus aimed to investigate the association between educational level and anticoagulation quality and clinical outcomes in elderly patients with acute VTE. We studied 817 patients aged ≥65 years with acute VTE from a Swiss prospective multicenter cohort study (09/2009-12/2013). We defined three educational levels: 1) less than high school, 2) high school, and 3) post-secondary degree. The primary outcome was the anticoagulation quality, expressed as the percentage of time spent in the therapeutic INR range (TTR). Secondary outcomes were the time to a first recurrent VTE and major bleeding. We adjusted for potential confounders and periods of anticoagulation. Overall, 56% of patients had less than high school, 25% a high school degree, and 18% a post-secondary degree. The mean percentage of TTR was similar across educational levels (less than high school, 61%; high school, 64%; and post-secondary, 63%; P = 0.36). Within three years of follow-up, patients with less than high school, high school, and a post-secondary degree had a cumulative incidence of recurrent VTE of 14.2%, 12.9%, and 16.4%, and a cumulative incidence of major bleeding of 13.3%, 15.1%, and 15.4%, respectively. After adjustment, educational level was neither associated with anticoagulation quality nor with recurrent VTE or major bleeding. In elderly patients with VTE, we did not find an association between educational level and anticoagulation quality or clinical outcomes. PMID:27606617

  2. Educational Level, Anticoagulation Quality, and Clinical Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Prospective Cohort Study

    PubMed Central

    Hofmann, Eveline; Faller, Nicolas; Limacher, Andreas; Méan, Marie; Tritschler, Tobias; Rodondi, Nicolas; Aujesky, Drahomir

    2016-01-01

    Whether the level of education is associated with anticoagulation quality and clinical outcomes in patients with acute venous thromboembolism (VTE) is uncertain. We thus aimed to investigate the association between educational level and anticoagulation quality and clinical outcomes in elderly patients with acute VTE. We studied 817 patients aged ≥65 years with acute VTE from a Swiss prospective multicenter cohort study (09/2009-12/2013). We defined three educational levels: 1) less than high school, 2) high school, and 3) post-secondary degree. The primary outcome was the anticoagulation quality, expressed as the percentage of time spent in the therapeutic INR range (TTR). Secondary outcomes were the time to a first recurrent VTE and major bleeding. We adjusted for potential confounders and periods of anticoagulation. Overall, 56% of patients had less than high school, 25% a high school degree, and 18% a post-secondary degree. The mean percentage of TTR was similar across educational levels (less than high school, 61%; high school, 64%; and post-secondary, 63%; P = 0.36). Within three years of follow-up, patients with less than high school, high school, and a post-secondary degree had a cumulative incidence of recurrent VTE of 14.2%, 12.9%, and 16.4%, and a cumulative incidence of major bleeding of 13.3%, 15.1%, and 15.4%, respectively. After adjustment, educational level was neither associated with anticoagulation quality nor with recurrent VTE or major bleeding. In elderly patients with VTE, we did not find an association between educational level and anticoagulation quality or clinical outcomes. PMID:27606617

  3. Prospective Molecular Profiling of Canine Cancers Provides a Clinically Relevant Comparative Model for Evaluating Personalized Medicine (PMed) Trials

    PubMed Central

    Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E. J.; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara

    2014-01-01

    Background Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. Methodology A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Conclusions Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week). Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer

  4. Evaluation of Clinical Outcomes after Abdominal Rectopexy and Delorme’s Procedure for Rectal Prolapse: A Prospective Study

    PubMed Central

    Makineni, Hemanth; Rai, B.K. Shivprasad

    2014-01-01

    Background: Complete rectal prolapse is characterized by protrusion of full thickness rectal wall through the anal orifice. Despite its rarity more than 100 surgical procedures have been described and there are no good evidence based recommendations for selection of a surgical procedure. This study was conducted to evaluate the clinical outcomes of commonly used procedures for rectal prolapse at our hospital. Materials and Methods: Twenty seven patients presenting with complete rectal prolapse between May 2011 to May 2013 were included in this prospective study. Patients underwent either Abdominal rectopexy or Delorme’s procedure after evaluation, based on clinical judgment of experienced surgeons. Patient characteristics, complications, post-operative length of hospitalization and clinical outcomes were assessed. Patients were followed up for a mean duration of 14 months. Results: Seventeen patients underwent Abdominal rectopexy (Posterior mesh rectopexy), ten patients underwent Delorme’s procedure. No postoperative mortalities or major complications were noted. Post operative morbidity (minor) was 17% in Abdominal rectopexy group and 10% in Delormes group 0%. Incontinence improved in all six patients (100%) in rectopexy group, four patients (80%) in Delorme’s procedure group. Two patients (11%) in rectopexy group reported increase in constipation post operatively. There was one recurrence in Delorme’s procedure group with no recurrences in Abdominal rectopexy group. Conclusion: The treatment of rectal prolapse should be individualized to achieve best results. Abdominal rectopexy can be safely applied in most of patients with minimal post operative increase in constipation and recurrence by using posterior mesh rectopexy technique. Delorme’s procedure can be performed with minimal morbidity and shorter hospital stay and good functional results with acceptable recurrence rate. Delorme’s can be considered as an alternative to rectopexy not only in

  5. Crown lengthening in the maxillary anterior region: a 6-month prospective clinical study.

    PubMed

    Deas, David E; Mackey, Scott A; Sagun, Ruben S; Hancock, Raymond H; Gruwell, Scott F; Campbell, Casey M

    2014-01-01

    The purpose of this study was to assess osseous parameters and stability of maxillary anterior teeth following crown lengthening surgery. Thirty-six patients requiring facial crown lengthening of 277 maxillary anterior and first premolar teeth were included. Presurgical and intraoperative clinical measurements were recorded at baseline and 1, 3, and 6 months postsurgery at midfacial, mesiofacial, and distofacial line angles. The data presented here suggest that when crown lengthening anterior maxillary teeth, the distance between the desired gingival margin and alveolar crest is usually insufficient to allow for biologic width. In addition, there is significant tissue rebound that may stabilize by 6 months. Tissue rebound appears related to flap position relative to the alveolar crest at suturing. These findings suggest that clinicians should establish proper anterior crown length with osseous resection.

  6. Transcrestal guided sinus lift without grafting materials: a 36 months clinical prospective study

    PubMed Central

    SPINELLI, D.; DE VICO, G.; CONDÒ, R.; OTTRIA, L.; ARCURI, C.

    2015-01-01

    SUMMARY Purpose This study describes the ability to perform a technique for bone regeneration in maxillary posterior deficit (TGSL) without the use of bone grafting materials using a highly minimally invasive protocol. Materials and methods Sixty six implants have been inserted in the sinus floor of a total of 39 patients through the transcrestal guided sinus lift technique (TGSL). All patients have been followed for at least three years in function. The drilling protocol was adapted on the basis of bone density of each implant site to achieve a torque between 45 and 55 Ncm. Healing titanium abutments tightened to 35 Ncm have been used. A CAD/CAM metal ceramics final prosthetic restoration has been generated a six months after the tissues healing and the provisional functionalization of the occlusion. Survival rate of implants and prostheses, biological and biomechanical complications, changes in marginal bone levels, and total height of alveolar crest bone before and after surgery have been evaluate and measured by the results obtained in this prospective study. It was also measured the periodontal parameters as well as levels of perception of pain by the patient during the entire recovery period. Results The result of the data of follow-up was 41.96 (24 to 36) months. Cumulative implant survival was 98.53% at 3 years. There were no biological and mechanical complications and there were no prosthetic failures during the whole period of follow-up. The Marginal Bone Loss (MBL) average during the first year of operation was from 0.33 to 0.36 mm, while the 3-year follow-up, the MBL average was 0.51 to 0.29 mm. The average of residual bone height of alveolar ridge before treatment was 6.7 to 1.6 mm (range 5.1 to 9.2 mm), while the average bone height was gained 6,4 – 1.6 mm (range 3.2 to 8.1 mm). All patients reported lower pain levels and found to have normal periodontal parameters. Conclusions This study suggests that the use of guided surgery to perform

  7. Evaluation of Hi-Tec Implant Restoration in Mandibular First Molar Region- A Prospective Clinical Study

    PubMed Central

    Sreeram, Roopa Rani. S.; Prasad, L Krishna; Chakravarthi, P Srinivas; Devi, Naga Neelima; Sreeram, Sanjay Krishna

    2015-01-01

    Background and Aims Missing teeth lead to loss of structural balance, inefficient function, poor aesthetics and psychological effects on human beings, which needs restoration for normal contour, function and aesthetics. Several natural or synthetic substitutes are being used for replacement of missing tooth since centuries. Implants are the latest modality of replacement. So, the study was aimed to assess clinical success rate of Hi-Tec implant; which is economical and new in market. Results of the study will help clinician for appropriate implant selection. Materials and Methods The study included 10 patients from 19 to 31 years and needed restoration of missing mandibular first molar. Restoration had done using Hi Tec Single-tooth implants with metal-ceramic single crown prosthesis after three months of osseointegration. The implants were evaluated clinically (bleeding on probing, probing depth, implant mobility- periotest) and radiographically (marginal bone loss and peri-implant radiolucency) for six years. The observers were blinded for the duration of the study to prevent bias. Results All the patients had uneventful post-surgical healing. No bleeding on probing, Implant mobility, peri-implant radiolucency with minimal marginal bone loss and constant probing depths were observed well within the normal range during follow-up periods. Conclusion Two stage single-tooth Hi Tec implant restoration can be used as a successful treatment modality for replacing mandibular first molar in an economic way. However, these results were obtained after 6 years of follow up with a smaller sample size, so long term multi center studies with a larger sample size is recommended for the predictability of success rate conclusively. PMID:26436053

  8. Compression ultrasonography for diagnostic management of patients with clinically suspected deep vein thrombosis: prospective cohort study.

    PubMed Central

    Cogo, A.; Lensing, A. W.; Koopman, M. M.; Piovella, F.; Siragusa, S.; Wells, P. S.; Villalta, S.; Büller, H. R.; Turpie, A. G.; Prandoni, P.

    1998-01-01

    OBJECTIVE: To evaluate the safety of withholding anticoagulant treatment from patients with clinically suspected deep vein thrombosis but normal findings on compression ultrasonography. DESIGN: Compression ultrasonography was done with a simplified diagnostic procedure limited to the common femoral vein in the groin and the popliteal vein extending down to the trifurcation of the calf veins. Patients with normal ultrasonography findings at presentation were retested 1 week later. MAIN OUTCOME MEASURE: The incidence of venous thromboembolic complications during follow up for 6 months in patients in whom anticoagulant treatment was withheld on the basis of normal results on two ultrasonography tests 1 week apart. SETTING: University research centres in four hospitals. RESULTS: A total of 1702 patients were included in the study. Abnormal results on compression ultrasonography at presentation or at 1 week were found in 400 and 12 patients, respectively, for a prevalence of deep vein thrombosis of 24%. None of the patients were lost to follow up. Venous thromboembolic complications during the week of serial testing occurred in a single patient and in eight patients during 6 months' follow up, resulting in a cumulative rate of venous thromboembolic complications of 0.7% (95% confidence interval 0.3% to 1.2%). The mean number of extra hospital visits and additional tests required per initially referred patient was 0.8. CONCLUSION: It is safe to withhold anticoagulant treatment from patients with clinically suspected deep vein thrombosis who have a normal result on compression ultrasonography at the time of presentation and at 1 week. PMID:9451260

  9. Efficacy of 0.25% Lemongrass Oil Mouthwash: A Three Arm Prospective Parallel Clinical Study

    PubMed Central

    Mohanty, Pritam; Tangade, Pradeep; Rajput, Prashant; Batra, Manu

    2015-01-01

    Background Chlorhexidine mouthwash has earned eponym of gold standard to treat and/or prevent periodontal diseases. However, the present study was carried out to explore an alternative herbal mouthwash. Aim To compare the anti-plaque and anti-gingivitis efficacy of a 0.25% lemongrass oil mouthwash to that of 0.2% chlorhexidine mouthwash. Materials and Methods A double-blinded parallel designed clinical trial with 60 subjects was taken for the study. Baseline plaque index (PI) & gingival index (GI) score was recorded. Oral prophylaxis was done and the plaque score was set at zero. Then, subjects were randomly allocated into 3 groups (N=20 in each): 0.25% lemongrass oil mouthwash, 0.2% chlorhexidine mouthwash and oral prophylaxis only. Subjects were asked to swish with respective mouthwash twice daily for 21 days. Subjects were again re-evaluated on 14th and 21st day for GI and PI. Comparison of the mean difference among the variables was performed by parametric tests. Results Lemongrass oil mouthwash group showed highest reduction in GI & PI at both 14th and 21st day, which was statistically significant (p≤0.05). Conclusion Lemongrass oil mouthwash can also be used as a good herbal alternative to chlorhexidine mouthwash, so further studies are needed. PMID:26557608

  10. Effects of kinesiotherapy, ultrasound and electrotherapy in management of bilateral knee osteoarthritis: prospective clinical trial

    PubMed Central

    2012-01-01

    Background Although recent advances in knee osteoarthritis (OA) treatment and evaluation were achieved, to the best of our knowledge, few studies have evaluated the longitudinal effect of therapeutic modalities on the functional exercise capacity of patients with knee OA. The purpose was to investigate the effects of kinesiotherapy and electrotherapy on functional exercise capacity, evaluated using the six-minute walk test (6-MWT) in patients with bilateral knee OA. Secondary measurements included range of motion (ROM), severity of knee pain (VAS), and a measure of perceived health and physical function, evaluated using the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. Methods A total of 40 women with bilateral knee OA were assigned to three groups: kinesiotherapy (KIN, n = 16), transcutaneous electrical nerve stimulation (TENS, n = 12), or ultrasound (US, n = 10). The groups underwent 12 weeks of intervention twice per week. The participants were subjected to the 6-MWT, ROM, VAS and WOMAC index. These tests were performed before and after the intervention. The study was focused on outpatients and was carried out at Universidade Estadual de Campinas, Brazil. Results At follow-up, the KIN and US groups had significantly higher 6-MWT distances (19.8 ± 21.7 and 14.1 ± 22.5%, respectively) compared with their respective pre-intervention values. All treatments were effective for reducing pain and improving the WOMAC index. Conclusions We demonstrated that the 6-MWT is a tool that can be used to evaluate improvements in the functional exercise capacity of patients submitted to a clinical intervention. PMID:22999098

  11. Transbuccal versus transoral approach for management of mandibular angle fractures: a prospective, clinical and radiographic study

    PubMed Central

    2016-01-01

    Objectives We compared the transbuccal and transoral approaches in the management of mandibular angle fractures. Materials and Methods Sixty patients with mandibular angle fractures were randomly divided into two equal groups (A, transoral approach; group B, transbuccal approach) who received fracture reduction using a single 2.5 mm 4 holed miniplate with a bar using either of the two approaches. Intraoperatively, the surgical time and the ease of surgical assess for fixation were noted. Patients were followed at 1 week, 3 months, and 6 months postoperatively and evaluated clinically for post-surgical complications like scarring, infection, postoperative occlusal discrepancy, malunion, and non-union. Radiographically, the interpretation of fracture reduction was also performed by studying the fracture gap following reduction using orthopantomogram tracing. The data was tabulated and subjected to statistical analysis. A P-value less than 0.05 was considered significant. Results No significant difference was seen between the two groups for variables like surgical time and ease of fixation. Radiographic interpretation of fracture reduction revealed statistical significance for group B from points B to D as compared to group A. No cases of malunion/non-union were noted. A single case of hypertrophic scar formation was noted in group B at 6 months postsurgery. Infection was noted in 2 patients in group B compared to 6 patients in group A. There was significantly more occlusal discrepancy in group A compared to group B at 1 week postoperatively, but no long standing discrepancy was noted in either group at the 6 months follow-up. Conclusion The transbuccal approach was superior to the transoral approach with regard to radiographic reduction of the fracture gap, inconspicuous external scarring, and fewer postoperative complications. We preferred the transbuccal approach due to ease of use, minimal requirement for plate bending, and facilitation of plate placement in the

  12. Clinical risk prediction for pre-eclampsia in nulliparous women: development of model in international prospective cohort

    PubMed Central

    McCowan, Lesley M E; Dekker, Gustaaf A; Poston, Lucilla; Chan, Eliza H Y; Stewart, Alistair W; Black, Michael A; Taylor, Rennae S; Walker, James J; Baker, Philip N; Kenny, Louise C

    2011-01-01

    Objectives To develop a predictive model for pre-eclampsia based on clinical risk factors for nulliparous women and to identify a subgroup at increased risk, in whom specialist referral might be indicated. Design Prospective multicentre cohort. Setting Five centres in Auckland, New Zealand; Adelaide, Australia; Manchester and London, United Kingdom; and Cork, Republic of Ireland. Participants 3572 “healthy” nulliparous women with a singleton pregnancy from a large international study; data on pregnancy outcome were available for 3529 (99%). Main outcome measure Pre-eclampsia defined as ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg, or both, on at least two occasions four hours apart after 20 weeks’ gestation but before the onset of labour, or postpartum, with either proteinuria or any multisystem complication. Preterm pre-eclampsia was defined as women with pre-eclampsia delivered before 37+0 weeks’ gestation. In the stepwise logistic regression the comparison group was women without pre-eclampsia. Results Of the 3529 women, 186 (5.3%) developed pre-eclampsia, including 47 (1.3%) with preterm pre-eclampsia. Clinical risk factors at 14-16 weeks’ gestation were age, mean arterial blood pressure, body mass index (BMI), family history of pre-eclampsia, family history of coronary heart disease, maternal birth weight, and vaginal bleeding for at least five days. Factors associated with reduced risk were a previous single miscarriage with the same partner, taking at least 12 months to conceive, high intake of fruit, cigarette smoking, and alcohol use in the first trimester. The area under the receiver operating characteristics curve (AUC), under internal validation, was 0.71. Addition of uterine artery Doppler indices did not improve performance (internal validation AUC 0.71). A framework for specialist referral was developed based on a probability of pre-eclampsia generated by the model of at least 15% or an abnormal uterine artery Doppler waveform in a

  13. Clinical Development and Implementation of an Institutional Guideline for Prospective EEG Monitoring and Reporting of Delayed Cerebral Ischemia.

    PubMed

    Muniz, Carlos F; Shenoy, Apeksha V; OʼConnor, Kathryn L; Bechek, Sophia C; Boyle, Emily J; Guanci, Mary M; Tehan, Tara M; Zafar, Sahar F; Cole, Andrew J; Patel, Aman B; Westover, Michael B; Rosenthal, Eric S

    2016-06-01

    Delayed cerebral ischemia (DCI) is the most common and disabling complication among patients admitted to the hospital for subarachnoid hemorrhage (SAH). Clinical and radiographic methods often fail to detect DCI early enough to avert irreversible injury. We assessed the clinical feasibility of implementing a continuous EEG (cEEG) ischemia monitoring service for early DCI detection as part of an institutional guideline. An institutional neuromonitoring guideline was designed by an interdisciplinary team of neurocritical care, clinical neurophysiology, and neurosurgery physicians and nursing staff and cEEG technologists. The interdisciplinary team focused on (1) selection criteria of high-risk patients, (2) minimization of safety concerns related to prolonged monitoring, (3) technical selection of quantitative and qualitative neurophysiologic parameters based on expert consensus and review of the literature, (4) a structured interpretation and reporting methodology, prompting direct patient evaluation and iterative neurocritical care, and (5) a two-layered quality assurance process including structured clinician interviews assessing events of neurologic worsening and an adjudicated consensus review of neuroimaging and medical records. The resulting guideline's clinical feasibility was then prospectively evaluated. The institutional SAH monitoring guideline used transcranial Doppler ultrasound and cEEG monitoring for vasospasm and ischemia monitoring in patients with either Fisher group 3 or Hunt-Hess grade IV or V SAH. Safety criteria focused on prevention of skin breakdown and agitation. Technical components included monitoring of transcranial Doppler ultrasound velocities and cEEG features, including quantitative alpha:delta ratio and percent alpha variability, qualitative evidence of new focal slowing, late-onset epileptiform activity, or overall worsening of background. Structured cEEG reports were introduced including verbal communication for findings concerning

  14. Clinical Development and Implementation of an Institutional Guideline for Prospective EEG Monitoring and Reporting of Delayed Cerebral Ischemia.

    PubMed

    Muniz, Carlos F; Shenoy, Apeksha V; OʼConnor, Kathryn L; Bechek, Sophia C; Boyle, Emily J; Guanci, Mary M; Tehan, Tara M; Zafar, Sahar F; Cole, Andrew J; Patel, Aman B; Westover, Michael B; Rosenthal, Eric S

    2016-06-01

    Delayed cerebral ischemia (DCI) is the most common and disabling complication among patients admitted to the hospital for subarachnoid hemorrhage (SAH). Clinical and radiographic methods often fail to detect DCI early enough to avert irreversible injury. We assessed the clinical feasibility of implementing a continuous EEG (cEEG) ischemia monitoring service for early DCI detection as part of an institutional guideline. An institutional neuromonitoring guideline was designed by an interdisciplinary team of neurocritical care, clinical neurophysiology, and neurosurgery physicians and nursing staff and cEEG technologists. The interdisciplinary team focused on (1) selection criteria of high-risk patients, (2) minimization of safety concerns related to prolonged monitoring, (3) technical selection of quantitative and qualitative neurophysiologic parameters based on expert consensus and review of the literature, (4) a structured interpretation and reporting methodology, prompting direct patient evaluation and iterative neurocritical care, and (5) a two-layered quality assurance process including structured clinician interviews assessing events of neurologic worsening and an adjudicated consensus review of neuroimaging and medical records. The resulting guideline's clinical feasibility was then prospectively evaluated. The institutional SAH monitoring guideline used transcranial Doppler ultrasound and cEEG monitoring for vasospasm and ischemia monitoring in patients with either Fisher group 3 or Hunt-Hess grade IV or V SAH. Safety criteria focused on prevention of skin breakdown and agitation. Technical components included monitoring of transcranial Doppler ultrasound velocities and cEEG features, including quantitative alpha:delta ratio and percent alpha variability, qualitative evidence of new focal slowing, late-onset epileptiform activity, or overall worsening of background. Structured cEEG reports were introduced including verbal communication for findings concerning

  15. The impact of a managed care obesity intervention on clinical outcomes and costs: A prospective observational study

    PubMed Central

    Rothberg, Amy E.; McEwen, Laura N.; Fraser, Tom; Burant, Charles F.; Herman, William H.

    2013-01-01

    Objective To evaluate the impact of a managed care obesity intervention that requires enrollment in an intensive medical weight management program, a commercial weight loss program, or a commercial pedometer-based walking program to maintain enhanced benefits. Design and Methods Prospective observational study involving 1,138 adults with BMI ≥32 kg/m2 with one or more comorbidities or BMI ≥35 kg/m2 enrolled in a commercial, independent practice association-model health maintenance organization. Body mass index, blood pressure, lipids, HbA1c or fasting glucose, and per-member per-month costs were assessed one year before and one year after program implementation. Results Program uptake (90%) and one year adherence (79%) were excellent. Enrollees in all three programs exhibited improved clinical outcomes and reduced rates of increase in direct medical costs compared to members who did not enroll in any program. Conclusions A managed care obesity intervention that offered financial incentives for participation and a variety of programs was associated with excellent program uptake and adherence, improvements in cardiovascular risk factors, and a lower rate of increase in direct medical costs over one year. PMID:24136667

  16. Long-term results of Troidl's technique of endoscopic pneumatic dilatation for achalasia of the esophagus. A prospective clinical trial.

    PubMed

    Eypasch, E; Troidl, H; Sommer, H; Vestweber, K H

    1987-01-01

    In a prospective clinical trial, 26 consecutive patients underwent endoscopic pneumatic dilatation over a 10-year period. Dilatation was achieved by means of a balloon attached to a normal gastrointestinal fiberscope. With the endoscope in an inverse position, the device was placed in the cardia and the dilatation process was monitored macroscopically. Before dilatation, patients suffered from dysphagia (92%), reduced speed of swallowing (100%), symptom aggravation under stress (73%), weight loss (50%), aspiration, pain, regurgitation, and vomiting. After dilatation and long-term follow-up (mean of 5 years), symptoms could be markedly reduced, especially the speed of eating and symptom aggravation under stress. Excellent and good results (Visick scale) were achieved in 76%. Fair results were achieved in 20%. To date, perforation and other complications have not occurred. Mortality was zero. Our series was an uncontrolled trial, so the results are hardly comparable to other studies. Furthermore, the small number of patients in our study represents a weak point with regard to complications. We conclude that the main advantages of the procedure are its simplicity and practicability. The simple procedure may be the method of choice in elderly patients. Of course, no final decision can be made until a well-designed controlled trial has been carried out.

  17. State anxiety and depression as factors modulating and influencing postoperative pain in dental implant surgery. A prospective clinical survey

    PubMed Central

    Gómez-de Diego, Rafael; Cutando-Soriano, Antonio; Montero-Martín, Javier; Prados-Frutos, Juan C.

    2014-01-01

    Objetives: To determine whether preoperative state anxiety and depression modulate or influence objective and subjective postoperative pain following dental implant insertion. Study Design: Prospective, clinical study with 7-day follow-up of a sample of 105 subjects who preoperatively completed the state anxiety questionnaire (STAI-E) and Beck Depression Inventory (BDI) and postoperatively, at 2 and 7 days, recorded objective pain with the Semmes-Weinstein mechanical esthesiometer (SW test) and subjective pain with the Visual Analog Scale (VAS). Results: 85.6% and 81.5% of patients, respectively, recorded no signs of state anxiety or depression. The correlation between anxiety and depression for both maxillary bones was the lower (P=0.02). The correlation between subjective and objective pain at 2 and 7 days, and the anatomic regions intervened, was statistically significant in the mandible at day 7 (P<0.01), and highly significant (P<0.001) for the other variables. The correlation between state anxiety and objective pain at day 7 was nearly statistically significant (P=0.07). Conclusions: The correlation between state anxiety and depression, and objective and subjective pain at day 7 was not statistically significant. A strong correlation was found between objective and subjective pain in the immediate postoperative period. Key words:Anxiety, depression, postoperative pain, dental implants. PMID:24880447

  18. 0.2-Tesla magnetic resonance imaging of internal lesions of the knee joint: a prospective arthroscopically controlled clinical study.

    PubMed

    Riel, K A; Reinisch, M; Kersting-Sommerhoff, B; Hof, N; Merl, T

    1999-01-01

    The results of magnetic resonance imaging (MRI) were compared with those of arthroscopy in a prospective series of 244 patients. A dedicated system for MRI of limbs and peripheral joints--the 0.2-T Artoscan (Esaote, Italy)--was used for imaging knee joint lesions. T1-weighted spin-echo sagittal images, T2-weighted gradient-echo coronal images, and axial views for lesions of the femoropatellar joint were acquired. Paraxial sagittal and oblique coronal views were obtained for imaging of the cruciate ligaments. This protocol allowed excellent visualization of the cruciate ligaments and medial and lateral meniscus in almost all patients. Compared with arthroscopy performed within 48 h after imaging, the sensitivity, specificity, and accuracy were respectively 93%, 97%, and 95% for tears of the medial meniscus; 82%, 96%, and 93% for tears of the lateral meniscus; 100%, 100%, and 100% for tears of the posterior cruciate ligament; 98%, 98%, and 97% for tears of the anterior cruciate ligament; and 72%, 100%, and 92% for full-thickness articular cartilage lesions. The examination can be performed within 30-45 min at lower cost than diagnostic arthroscopy. MRI with a 0.2-T magnet is a safe and valuable adjunct to the clinical examination of the knee and an aid to efficient preoperative planning.

  19. Clinical outcome and regression patterns of retinoblastoma treated with systemic chemoreduction and focal therapy: A prospective study

    PubMed Central

    Chawla, Bhavna; Jain, Amit; Seth, Rachna; Azad, Rajvardhan; Mohan, VK; Pushker, Neelam; Ghose, Supriyo

    2016-01-01

    Purpose: To prospectively study the clinical outcome and regression patterns of early retinoblastoma (Groups A and B) after systemic chemotherapy and focal consolidation in Indian children. Materials and Methods: Group A eyes were treated with focal therapy (transpupillary thermotherapy/cryotherapy) and Group B with systemic chemoreduction and focal therapy. Outcome measures were efficacy and safety of treatment, risk factors for treatment failure, regression patterns, and factors predictive of regression patterns. Results: Of 119 eyes (216 tumors), 14 (11.8%) were Group A and 105 (88.2%) were Group B eyes. The mean follow-up was 22.6 months. Tumor control was achieved in 111/119 eyes (93.3% overall, 100% Group A, 92.4% Group B). Eight Group B eyes (6.7%) had treatment failure. No serious systemic side-effects were noted. Risk factors for failure included larger tumors (P = 0.001) and proximity to posterior pole (P = 0.014). Regression patterns were Type 4 (50.2%), Type 3 (31.7%), Type 1 (11.1%), and Type 2 (7%). Factors predictive of Type 4 regression were smaller tumors, anterior location, younger age; Type 3 regression was associated with larger tumors, macular location, and older age. Conclusions: Systemic chemoreduction and focal therapy provided effective tumor control in Indian children. Factors predictive of regression patterns included age, tumor size and its location, and the modality of treatment. PMID:27609166

  20. Cutaneous and Labyrinthine Tolerance of Bioactive Glass S53P4 in Mastoid and Epitympanic Obliteration Surgery: Prospective Clinical Study

    PubMed Central

    Bernardeschi, Daniele; Nguyen, Yann; Russo, Francesca Yoshie; Mosnier, Isabelle; Ferrary, Evelyne; Sterkers, Olivier

    2015-01-01

    Objective. To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 when used in the mastoid and epitympanic obliteration for chronic otitis surgery. Material and Methods. Forty-one cases have been included in this prospective study. Cutaneous tolerance was clinically evaluated 1 week, 1 month, and 3 months after surgery with a physical examination of the retroauricular and external auditory canal (EAC) skin and the presence of otalgia; the inner ear tolerance was assessed by bone-conduction hearing threshold 1 day after surgery and by the presence of vertigo or imbalance. Results. All surgeries but 1 were uneventful: all patients maintained the preoperative bone-conduction hearing threshold except for one case in which the round window membrane was opened during the dissection of the cholesteatoma in the hypotympanum and this led to a dead ear. No dizziness or vertigo was reported. Three months after surgery, healing was achieved in all cases with a healthy painless skin. No cases of revision surgery for removal of the granules occurred in this study. Conclusion. The bioactive glass S53P4 is a well-tolerated biomaterial for primary or revision chronic otitis surgery, as shown by the local skin reaction which lasted less than 3 months and by the absence of labyrinthine complications. PMID:26504792

  1. Comfort, satisfaction, and anxiolysis in surgical patients using a patient-adjustable comfort warming system: a prospective randomized clinical trial.

    PubMed

    O'Brien, Denise; Greenfield, Mary Lou V H; Anderson, Jane E; Smith, Beverly A; Morris, Michelle

    2010-04-01

    Comfort warming systems aim to produce a comfortable local environment over which the individual patient has control. We studied a patient-adjustable comfort warming system using the Bair PAWS (Patient Adjustable Warming System) (Arizant Healthcare, Inc, Eden Prairie, MN), specifically to study comfort warming rather than therapeutic warming. One-hundred thirty patients were enrolled in this prospective randomized clinical trial, with 58 patients randomized to the patient warming gown, and 72 randomized to the warm blanket group. Groups were similar for gender, age, height, weight, surgical time, body surface area, and body mass index. The patient-adjustable warming system group had perceived greater control and satisfaction at 30 minutes after treatment was initiated compared with the warmed blanket control group. However, there were no differences in satisfaction levels with thermal comfort among those patients contacted one day postoperatively. Additional research is needed to improve external validity of study findings. Further refinement of a nursing definition of thermal comfort should be explored. PMID:20359643

  2. Prospective clinical, scintigraphic, angiographic and functional evaluation of patients after inferior myocardial infarction with and without right ventricular dysfunction

    SciTech Connect

    Haines, D.E.; Beller, G.A.; Watson, D.D.; Nygaard, T.W.; Craddock, G.B.; Cooper, A.A.; Gibson, R.S.

    1985-11-01

    To elucidate the functional and prognostic significance of right ventricular dysfunction after acute inferior wall myocardial infarction, 74 consecutive patients with inferior infarction were prospectively evaluated with gated equilibrium blood pool imaging at rest, submaximal exercise thallium-201 scintigraphy and coronary angiography before hospital discharge. In addition, symptom-limited stress thallium-201 scintigraphy was performed in 61 patients at 3 months, and all patients were followed up clinically for 23 +/- 15 months. Utilizing predetermined radionuclide angiographic criteria, 47 patients (Group I) had normal right ventricular function, 12 patients (Group II) had mild to moderate dysfunction and 15 patients (Group III) had severe right ventricular dysfunction. Exercise tolerance as assessed by treadmill time, blood pressure-heart rate product and peak work load in METS was comparable among the three groups, both before hospital discharge and at 3 month follow-up. No differences in indicators of exercise-induced ischemia were noted among the groups, including the prevalence of redistribution thallium-201 defects, ST segment depression or symptoms of chest pain. Finally, cardiac mortality, reinfarction rate and the incidence of medically refractory angina pectoris were similar in the three groups. Thus, right ventricular dysfunction after acute inferior wall myocardial infarction does not appear to limit exercise tolerance or identify a subgroup of patients at higher risk for recurrent cardiac events.

  3. Prospective Clinical Trial of Bladder Filling and Three-Dimensional Dosimetry in High-Dose-Rate Vaginal Cuff Brachytherapy

    SciTech Connect

    Stewart, Alexandra J.; Cormack, Robert A.; Lee, Hang; Xiong Li; Hansen, Jorgen L.; O'Farrell, Desmond A.; Viswanathan, Akila N.

    2008-11-01

    Purpose: To investigate the effect of bladder filling on dosimetry and to determine the best bladder dosimetric parameter for vaginal cuff brachytherapy. Methods and Materials: In this prospective clinical trial, a total of 20 women underwent vaginal cylinder high-dose-rate brachytherapy. The bladder was full for Fraction 2 and empty for Fraction 3. Dose-volume histogram and dose-surface histogram values were generated for the bladder, rectum, and urethra. The midline maximal bladder point (MBP) and the midline maximal rectal point were recorded. Paired t tests, Pearson correlations, and regression analyses were performed. Results: The volume and surface area of the irradiated bladder were significantly smaller when the bladder was empty than when full. Of the several dose-volume histogram and dose-surface histogram parameters evaluated, the bladder maximal dose received by 2 cm{sup 3} of tissue, volume of bladder receiving {>=}50% of the dose, volume of bladder receiving {>=}70% of the dose, and surface area of bladder receiving {>=}50% of the dose significantly predicted for the difference between the empty vs. full filling state. The volume of bladder receiving {>=}70% of the dose and the maximal dose received by 2 cm{sup 3} of tissue correlated significantly with the MBP. Bladder filling did not alter the volume or surface area of the rectum irradiated. However, an empty bladder did result in the nearest point of bowel being significantly closer to the vaginal cylinder than when the bladder was full. Conclusions: Patients undergoing vaginal cuff brachytherapy treated with an empty bladder have a lower bladder dose than those treated with a full bladder. The MBP correlated well with the volumetric assessments of bladder dose and provided a noninvasive method for reporting the MBP dose using three-dimensional imaging. The MBP can therefore be used as a surrogate for complex dosimetry in the clinic.

  4. The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes in a prospective observational study

    PubMed Central

    2013-01-01

    Objective To compare regimens consisting of either efavirenz or nevirapine and two or more nucleoside reverse transcriptase inhibitors (NRTIs) among HIV-infected, antiretroviral-naive, and AIDS-free individuals with respect to clinical, immunologic, and virologic outcomes. Design Prospective studies of HIV-infected individuals in Europe and the US included in the HIV-CAUSAL Collaboration. Methods Antiretroviral therapy-naive and AIDS-free individuals were followed from the time they started an NRTI, efavirenz or nevirapine, classified as following one or both types of regimens at baseline, and censored when they started an ineligible drug or at 6 months if their regimen was not yet complete. We estimated the ‘intention-to-treat’ effect for nevirapine versus efavirenz regimens on clinical, immunologic, and virologic outcomes. Our models included baseline covariates and adjusted for potential bias introduced by censoring via inverse probability weighting. Results A total of 15 336 individuals initiated an efavirenz regimen (274 deaths, 774 AIDS-defining illnesses) and 8129 individuals initiated a nevirapine regimen (203 deaths, 441 AIDS-defining illnesses). The intention-to-treat hazard ratios [95% confidence interval (CI)] for nevirapine versus efavirenz regimens were 1.59 (1.27, 1.98) for death and 1.28 (1.09, 1.50) for AIDS-defining illness. Individuals on nevirapine regimens experienced a smaller 12-month increase in CD4 cell count by 11.49 cells/μl and were 52% more likely to have virologic failure at 12 months as those on efavirenz regimens. Conclusions Our intention-to-treat estimates are consistent with a lower mortality, a lower incidence of AIDS-defining illness, a larger 12-month increase in CD4 cell count, and a smaller risk of virologic failure at 12 months for efavirenz compared with nevirapine. PMID:22546987

  5. The effect of hydroxyapatite coated screw in the lateral fragility fractures of the femur. A prospective randomized clinical study.

    PubMed

    Pesce, V; Maccagnano, G; Vicenti, G; Notarnicola, A; Moretti, L; Tafuri, S; Vanni, D; Salini, V; Moretti, B

    2014-01-01

    Due to a growing numbers of lateral fragility fractures of the femur and their high social costs the need to work out an effective strategy in order to find a better solution for these patients is warranted. From January 2010 to July 2011, we carried out a prospective randomized clinical study comparing the results of patients with femoral lateral fractures treated by nail and cephalic hydroxyapatite coated screws (study group including 27 patients) compared to the patients with the same fractures treated with nail and head standard screws (control group including 27 patients). We defined the two parts of the femoral neck as ROI 1 (under the head screw) and ROI 2 (above the femoral screw) on the AP view. The bone density of the two areas was calculated using DEXA at T0 (1st day post-surgery), at T1 (40th day post-surgery), at T2 (3 months later), at T3 (1 year later). The clinical-radiography evaluations were based on the Harris Hip Score (HHS), ADL test and x-ray views of the hip. As far as the bone mineral density average of ROI 1 and ROI 2 is concerned, we found a significant statistical increase at T1 and T3 in the study group, while it was not significant in the control group. We could account for this data through the higher mechanical stability of hydroxyapatite coated screws than standard screws. In fact, this material was responsible for improved implant osteointegration. Thanks to a 1 year follow-up we were able to demonstrate the implant utility associated with augmentation and the importance of densitometry exams such as easily repeatable and low cost diagnostics to prevent the onset of complications linked to screw loosening.

  6. Postoperative complications and clinical outcomes among patients undergoing thoracic and gastrointestinal cancer surgery: A prospective cohort study

    PubMed Central

    Martos-Benítez, Frank Daniel; Gutiérrez-Noyola, Anarelys; Echevarría-Víctores, Adisbel

    2016-01-01

    Objective This study sought to determine the influence of postoperative complications on the clinical outcomes of patients who underwent thoracic and gastrointestinal cancer surgery. Methods A prospective cohort study was conducted regarding 179 consecutive patients who received thorax or digestive tract surgery due to cancer and were admitted to an oncological intensive care unit. The Postoperative Morbidity Survey was used to evaluate the incidence of postoperative complications. The influence of postoperative complications on both mortality and length of hospital stay were also assessed. Results Postoperative complications were found for 54 patients (30.2%); the most common complications were respiratory problems (14.5%), pain (12.9%), cardiovascular problems (11.7%), infectious disease (11.2%), and surgical wounds (10.1%). A multivariate logistic regression found that respiratory complications (OR = 18.68; 95%CI = 5.59 - 62.39; p < 0.0001), cardiovascular problems (OR = 5.06, 95%CI = 1.49 - 17.13; p = 0.009), gastrointestinal problems (OR = 26.09; 95%CI = 6.80 - 100.16; p < 0.0001), infectious diseases (OR = 20.55; 95%CI = 5.99 - 70.56; p < 0.0001) and renal complications (OR = 18.27; 95%CI = 3.88 - 83.35; p < 0.0001) were independently associated with hospital mortality. The occurrence of at least one complication increased the likelihood of remaining hospitalized (log-rank test, p = 0.002). Conclusions Postoperative complications are frequent disorders that are associated with poor clinical outcomes; thus, structural and procedural changes should be implemented to reduce postoperative morbidity and mortality. PMID:27096675

  7. Resident trainees do not affect patient satisfaction in an outpatient gastroenterology clinic: A prospective study conducted in a Canadian gastroenterology clinic

    PubMed Central

    Brahmania, Mayur; Young, Madison; Muthiah, Chetty; Ilnyckyj, Alexandra; Duerksen, Donald; Moffatt, Dana C

    2015-01-01

    BACKGROUND: There is little literature regarding how a gastroenterology trainee affects a patient’s interpretation of care during outpatient clinic visits. Improving patient satisfaction is desirable and benefits may include enhanced patient compliance as well as providing trainees with areas for improvement. OBJECTIVES: To evaluate patient satisfaction in an outpatient gastroenterology clinic when seen by a trainee and attending physician versus an attending physician alone. The secondary objective was to evaluate physician characteristics that play a role in creating a positive clinical experience. METHODS: A randomized prospective survey study was conducted over an 11-month period (July 2012 to June 2013) at St Boniface Hospital (Winnipeg, Manitoba). Two gastroenterology fellows (postgraduate year 4 and 5) and nine internal medicine residents (postgraduate year 1 to 3) comprised the ‘trainee’ role, while three academic clinicians comprised the ‘attending’ role. Patients included individuals seen for an initial consultation and were >18 years of age. RESULTS: A total of 211 patients comprised the final study group, with 118 in the attending group and 93 in the trainee group. In univariate analysis, patients more often had a very good experience when seen by an attending physician alone versus a trainee and attending physician (73% versus 56%; P=0.016); however, on multivariate analysis, there was no significant difference in patient satisfaction (OR 0.89; P=0.931). Physician factors found to be associated with high patient satisfaction on multivariate analysis included: addressing all patient concerns (OR 27.56; P=0.021); giving the patient a preliminary diagnosis (OR 78.02; P=0.006); and feeling the physician was thorough (OR 72.53; P=0.029). CONCLUSIONS: The present study did not reveal a difference in patient satisfaction if a patient sees an attending physician alone or with a trainee. Moreover, to improve patient satisfaction in a gastroenterology

  8. Dose properties of a laser accelerated electron beam and prospects for clinical application.

    PubMed

    Kainz, K K; Hogstrom, K R; Antolak, J A; Almond, P R; Bloch, C D; Chiu, C; Fomytskyi, M; Raischel, F; Downer, M; Tajima, T

    2004-07-01

    Laser wakefield acceleration (LWFA) technology has evolved to where it should be evaluated for its potential as a future competitor to existing technology that produces electron and x-ray beams. The purpose of the present work is to investigate the dosimetric properties of an electron beam that should be achievable using existing LWFA technology, and to document the necessary improvements to make radiotherapy application for LWFA viable. This paper first qualitatively reviews the fundamental principles of LWFA and describes a potential design for a 30 cm accelerator chamber containing a gas target. Electron beam energy spectra, upon which our dose calculations are based, were obtained from a uniform energy distribution and from two-dimensional particle-in-cell (2D PIC) simulations. The 2D PIC simulation parameters are consistent with those reported by a previous LWFA experiment. According to the 2D PIC simulations, only approximately 0.3% of the LWFA electrons are emitted with an energy greater than 1 MeV. We studied only the high-energy electrons to determine their potential for clinical electron beams of central energy from 9 to 21 MeV. Each electron beam was broadened and flattened by designing a dual scattering foil system to produce a uniform beam (103%>off-axis ratio>95%) over a 25 x 25 cm2 field. An energy window (deltaE) ranging from 0.5 to 6.5 MeV was selected to study central-axis depth dose, beam flatness, and dose rate. Dose was calculated in water at a 100 cm source-to-surface distance using the EGS/BEAM Monte Carlo algorithm. Calculations showed that the beam flatness was fairly insensitive to deltaE. However, since the falloff of the depth-dose curve (R10-R90) and the dose rate both increase with deltaE, a tradeoff between minimizing (R10-R90) and maximizing dose rate is implied. If deltaE is constrained so that R10-R90 is within 0.5 cm of its value for a monoenergetic beam, the maximum practical dose rate based on 2D PIC is approximately 0.1 Gy min

  9. Multicountry Prospective Clinical Evaluation of Two Enzyme-Linked Immunosorbent Assays and Two Rapid Diagnostic Tests for Diagnosing Dengue Fever

    PubMed Central

    Dauner, Allison L.; Valks, Andrea; Forshey, Brett M.; Long, Kanya C.; Thaisomboonsuk, Butsaya; Sierra, Gloria; Picos, Victor; Talmage, Sara; Morrison, Amy C.; Halsey, Eric S.; Comach, Guillermo; Yasuda, Chadwick; Loeffelholz, Michael; Jarman, Richard G.; Fernandez, Stefan; An, Ung Sam; Kochel, Tadeusz J.; Jasper, Louis E.; Wu, Shuenn-Jue L.

    2015-01-01

    We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks. PMID:25588659

  10. Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever.

    PubMed

    Pal, Subhamoy; Dauner, Allison L; Valks, Andrea; Forshey, Brett M; Long, Kanya C; Thaisomboonsuk, Butsaya; Sierra, Gloria; Picos, Victor; Talmage, Sara; Morrison, Amy C; Halsey, Eric S; Comach, Guillermo; Yasuda, Chadwick; Loeffelholz, Michael; Jarman, Richard G; Fernandez, Stefan; An, Ung Sam; Kochel, Tadeusz J; Jasper, Louis E; Wu, Shuenn-Jue L

    2015-04-01

    We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks. PMID:25588659

  11. Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever.

    PubMed

    Pal, Subhamoy; Dauner, Allison L; Valks, Andrea; Forshey, Brett M; Long, Kanya C; Thaisomboonsuk, Butsaya; Sierra, Gloria; Picos, Victor; Talmage, Sara; Morrison, Amy C; Halsey, Eric S; Comach, Guillermo; Yasuda, Chadwick; Loeffelholz, Michael; Jarman, Richard G; Fernandez, Stefan; An, Ung Sam; Kochel, Tadeusz J; Jasper, Louis E; Wu, Shuenn-Jue L

    2015-04-01

    We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.

  12. Methodological issues in observational studies and non-randomized controlled trials in oncology in the era of big data.

    PubMed

    Tanaka, Shiro; Tanaka, Sachiko; Kawakami, Koji

    2015-04-01

    Non-randomized controlled trials, cohort studies and database studies are appealing study designs when there are urgent needs for safety data, outcomes of interest are rare, generalizability is a matter of concern, or randomization is not feasible. This paper reviews four typical case studies from methodological viewpoints and clarifies how to minimize bias in observational studies in oncology. In summary, researchers planning observational studies should be cautious of selection of appropriate databases, validity of algorithms for identifying outcomes, comparison with incident users or self-control, rigorous collection of information on potential confounders and reporting details of subject selection. Further, a careful study protocol and statistical analysis plan are also necessary.

  13. Clinical efficacy of intra-articular injections in knee osteoarthritis: a prospective randomized study comparing hyaluronic acid and betamethasone

    PubMed Central

    Trueba Davalillo, Cesáreo Ángel; Trueba Vasavilbaso, Cesáreo; Navarrete Álvarez, José Mario; Coronel Granado, Pilar; García Jiménez, Ozcar Alejandro; Gimeno del Sol, Mercedes; Gil Orbezo, Félix

    2015-01-01

    Background Osteoarthritis (OA) is the most common joint disease and leading cause of disability. Intra-articular (IA) administration of hyaluronic acid (HA) or corticosteroids (CS) have been previously studied, though using insufficient number of patients or short follow-up periods. Objective We evaluate HA and CS in patients with knee OA in terms of clinical efficacy over 12 months. Methods We used a prospective, randomized study with parallel groups. Randomized patients received IA injections of HA or betamethasone (BM). The primary outcomes were improvement in pain using Visual Analog Scale and function in the Western Ontario and McMaster University Osteoarthritis Index (Likert scale). Follow-up visits were scheduled at 3 months, 6 months, 9 months, and 12 months. Results A total of 200 patients were included. Pain was significantly reduced in both groups at the first follow-ups. At 12 months, the mean pain reduction in the HA group was 33.6% (95% CI: 31.1–36.1) compared to 8.2% (95% CI: 5.2–11.1) in BM (P<0.0001). Function improvement was higher in HA through every visit, and mean improvement at 12 months was 47.5% (95% CI: 45.6–49.3) in HA patients vs 13.2% (95% CI: 11.4–14.9) in the BM group (P<0.0001). All patients from both groups achieved the Minimal Clinically Important Improvement (MCII) for both pain and function up to 6 months. At 9 months and 12 months, the MCII figures were higher in HA group with ≥80% compared to ≤10% in BM group (P<0.0001). Adverse reactions were rare and related to the administration procedure. Conclusion Both treatments effectively controlled OA symptoms. BM showed higher short-term effectiveness, while HA showed better long-term effectiveness, maintaining clinical efficacy in a large number of patients 1 year after administration. PMID:27790040

  14. Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: A prospective, multicenter, cohort study

    PubMed Central

    2011-01-01

    Background Observational studies have previously shown that adverse events following manipulation to the neck and/or back are relatively common, although these reactions tend to be mild in intensity and self-limiting. However, no prospective study has examined the incidence of adverse reactions following spinal adjustments using upper cervical techniques, and the impact of this care on clinical outcomes. Methods Consecutive new patients from the offices of 83 chiropractors were recruited for this practice-based study. Clinical outcome measures included 1) Neck pain disability index (100-point scale), 2) Oswestry back pain index (100-point scale), 3) 11-point numerical rating scale (NRS) for neck, headache, midback, and low back pain, 4) treatment satisfaction, and 5) Symptomatic Reactions (SR). Data were collected at baseline, and after approximately 2 weeks of care. A patient reaching sub-clinical status for pain and disability was defined as a follow-up score <3 NRS and <10%, respectively. A SR is defined as a new complaint not present at baseline or a worsening of the presenting complaint by >30% based on an 11-point numeric rating scale occurring <24 hours after any upper cervical procedure. Results A total of 1,090 patients completed the study having 4,920 (4.5 per patient) office visits requiring 2,653 (2.4 per patient) upper cervical adjustments over 17 days. Three hundred thirty- eight (31.0%) patients had SRs meeting the accepted definition. Intense SR (NRS ≥8) occurred in 56 patients (5.1%). Outcome assessments were significantly improved for neck pain and disability, headache, mid-back pain, as well as lower back pain and disability (p <0.001) following care with a high level (mean = 9.1/10) of patient satisfaction. The 83 chiropractors administered >5 million career upper cervical adjustments without a reported incidence of serious adverse event. Conclusions Upper cervical chiropractic care may have a fairly common occurrence of mild intensity SRs

  15. Anterior cruciate ligament reconstruction with BPTB autograft, irradiated versus non-irradiated allograft: a prospective randomized clinical study.

    PubMed

    Sun, Kang; Tian, Shaoqi; Zhang, Jihua; Xia, Changsuo; Zhang, Cailong; Yu, Tengbo

    2009-05-01

    The effect of using gamma irradiation to sterilize bone-patellar tendon-bone (BPTB) allograft on the clinical outcomes of anterior cruciate ligament (ACL) reconstruction with irradiated allograft remains controversial. Our study was aimed to analyze the clinical outcomes of arthroscopic ACL reconstruction with irradiated BPTB allograft compared with non-irradiated allograft and autograft. All BPTB allografts were obtained from a single tissue bank and the irradiated allografts were sterilized with 2.5 Mrad of irradiation prior to distribution. A total of 102 patients undergoing arthroscopic ACL reconstruction were prospectively randomized consecutively into three groups. The same surgical technique was used in all operations done by the same senior surgeon. Before surgery and at the average of 31 months follow-up (range 24-47 months) patients were evaluated by the same observer according to objective and subjective clinical evaluations. Of these patients, 99 (autograft 33, non-irradiated allograft 34, irradiated allograft 32) were available for full evaluation. When compared the irradiated allograft group to non-irradiated allograft group or autograft group at 31 months follow-up by the Lachman test, ADT, pivot shift test and KT-2000 arthrometer testing, statistically significant differences were found. Most importantly, 87.8% of patients in the Auto group, 85.3% in the Non-Ir-Auto group and just only 31.3% in the Ir-Allo group had a side-to-side difference of less than 3 mm according to KT-2000. The failure rate of the ACL reconstruction with irradiated allograft (34.4%) was higher than that with autograft (6.1%) and non-irradiated allograft (8.8%). The anterior and rotational stability decreased significantly in the irradiated allograft group. According to the overall IKDC, functional, subjective evaluations and activity level testing, no statistically significant differences were found between the three groups. However, there was a trend that the functional and

  16. A Global View of the Relationships between the Main Behavioural and Clinical Cardiovascular Risk Factors in the GAZEL Prospective Cohort

    PubMed Central

    Meneton, Pierre; Lemogne, Cédric; Herquelot, Eléonore; Bonenfant, Sébastien; Larson, Martin G.; Vasan, Ramachandran S.; Ménard, Joël; Goldberg, Marcel; Zins, Marie

    2016-01-01

    Although it has been recognized for a long time that the predisposition to cardiovascular diseases (CVD) is determined by many risk factors and despite the common use of algorithms incorporating several of these factors to predict the overall risk, there has yet been no global description of the complex way in which CVD risk factors interact with each other. This is the aim of the present study which investigated all existing relationships between the main CVD risk factors in a well-characterized occupational cohort. Prospective associations between 12 behavioural and clinical risk factors (gender, age, parental history of CVD, non-moderate alcohol consumption, smoking, physical inactivity, obesity, hypertension, dyslipidemia, diabetes, sleep disorder, depression) were systematically tested using Cox regression in 10,736 middle-aged individuals free of CVD at baseline and followed over 20 years. In addition to independently predicting CVD risk (HRs from 1.18 to 1.97 in multivariable models), these factors form a vast network of associations where each factor predicts, and/or is predicted by, several other factors (n = 47 with p<0.05, n = 37 with p<0.01, n = 28 with p<0.001, n = 22 with p<0.0001). Both the number of factors associated with a given factor (1 to 9) and the strength of the associations (HRs from 1.10 to 6.12 in multivariable models) are very variable, suggesting that all the factors do not have the same influence within this network. These results show that there is a remarkably extensive network of relationships between the main CVD risk factors which may have not been sufficiently taken into account, notably in preventive strategies aiming to lower CVD risk. PMID:27598908

  17. Protocol of a Thyroid Cancer Longitudinal Study (T-CALOS): a prospective, clinical and epidemiological study in Korea

    PubMed Central

    Lee, Kyu Eun; Park, Young Joo; Cho, Belong; Hwang, Yunji; Choi, June Young; Kim, Su-jin; Choi, Hoonsung; Choi, Ho-Chun; An, Ah Reum; Park, Do Joon; Park, Sue K; Youn, Yeo-Kyu

    2015-01-01

    Introduction Thyroid cancer incidence in Korea is the highest in the world and has recently increased steeply. However, factors contributing to this sudden increase have not been fully elucidated, and few studies have explored the postoperative prognosis. The Thyroid Cancer Longitudinal Study (T-CALOS) was initiated with three aims: (1) to identify factors predicting quality of life, recurrence, and incidence of other diseases after thyroid cancer treatments; (2) to investigate environmental exposure to radiation, toxicants and molecular factors in relation to tumour aggressiveness; and (3) to evaluate gene–environment interactions that increase thyroid cancer in comparison with healthy participants from a pool of nationwide population-based healthy examinees. Methods and analysis T-CALOS enrols patients with incident thyroid cancer from three general hospitals, Seoul National University Hospital, Seoul National University Bundang Hospital and National Medical Center, Korea. The study is an ongoing project expecting to investigate 5000 patients with thyroid cancer up until 2017. Healthy examinees with a normal thyroid confirmed by sonography have been enrolled at the Healthy Examination Center at Seoul National University Hospital. We are also performing individual matching using two nationwide databases that are open to the public. Follow-up information is obtained at patients’ clinical visits and by linkage to the national database. For statistical analysis, we will use conditional logistic regression models and a Cox proportional hazard regression model. A number of stratifications and sensitivity analyses will be performed to confirm the results. Ethics and dissemination Based on a large sample size, a prospective study design, comprehensive data collection and biobank, T-CALOS has been independently peer-reviewed and approved by the three hospitals and two funding sources (National Research Foundation of Korea and Korean Foundation for Cancer Research

  18. A Global View of the Relationships between the Main Behavioural and Clinical Cardiovascular Risk Factors in the GAZEL Prospective Cohort.

    PubMed

    Meneton, Pierre; Lemogne, Cédric; Herquelot, Eléonore; Bonenfant, Sébastien; Larson, Martin G; Vasan, Ramachandran S; Ménard, Joël; Goldberg, Marcel; Zins, Marie

    2016-01-01

    Although it has been recognized for a long time that the predisposition to cardiovascular diseases (CVD) is determined by many risk factors and despite the common use of algorithms incorporating several of these factors to predict the overall risk, there has yet been no global description of the complex way in which CVD risk factors interact with each other. This is the aim of the present study which investigated all existing relationships between the main CVD risk factors in a well-characterized occupational cohort. Prospective associations between 12 behavioural and clinical risk factors (gender, age, parental history of CVD, non-moderate alcohol consumption, smoking, physical inactivity, obesity, hypertension, dyslipidemia, diabetes, sleep disorder, depression) were systematically tested using Cox regression in 10,736 middle-aged individuals free of CVD at baseline and followed over 20 years. In addition to independently predicting CVD risk (HRs from 1.18 to 1.97 in multivariable models), these factors form a vast network of associations where each factor predicts, and/or is predicted by, several other factors (n = 47 with p<0.05, n = 37 with p<0.01, n = 28 with p<0.001, n = 22 with p<0.0001). Both the number of factors associated with a given factor (1 to 9) and the strength of the associations (HRs from 1.10 to 6.12 in multivariable models) are very variable, suggesting that all the factors do not have the same influence within this network. These results show that there is a remarkably extensive network of relationships between the main CVD risk factors which may have not been sufficiently taken into account, notably in preventive strategies aiming to lower CVD risk. PMID:27598908

  19. Is aggressive gap arthroplasty essential in the management of temporomandibular joint ankylosis?-a prospective clinical study of 15 cases.

    PubMed

    Babu, Lokesh; Jain, Manoj Kumar; Ramesh, C; Vinayaka, N

    2013-09-01

    The purpose of this three-year, prospective, follow-up study was to evaluate whether aggressive gap arthroplasty is essential in the management of ankylosis of the temporomandibular joint (TMJ). Fifteen patients were treated by the creation of a minimal gap of 5-8mm and insertion of an interpositional gap arthroplasty using the temporalis fascia. Eleven patients had unilateral coronoidectomy and 4 bilateral coronoidectomy based on Kaban's protocol. Preoperative assessment included recording of history, clinical and radiological examinations, personal variables, the aetiology of the ankylosis, the side affected, and any other relevant findings. Patients were assessed postoperatively by a surgeon unaware of the treatment given for a minimum of 3 years, which included measurement of the maximal incisal opening, presence of facial nerve paralysis, recurrence, and any other relevant findings. Of the 15 patients (17 joints), 12 had unilateral and three had bilateral involvement, with trauma being the most common cause. The patients were aged between 7 and 29 years (mean (SD) age 20 (8) years). Preoperative maximal incisal opening was 0-2mm in 8 cases and 2-9mm in 9. Postoperatively adequate mouth opening of 30-40mm was achieved in all cases, with no recurrence or relevant malocclusion during 3-year follow up. However, patients will be followed up for 10 years. Aggressive gap arthroplasty is not essential in the management of ankylosis of the TMJ. Minimal gap interpositional arthroplasty with complete removal of the mediolateral ankylotic mass is a feasible and effective method of preventing recurrence. PMID:23219020

  20. Glucose Homeostasis and Weight Loss in Morbidly Obese Patients Undergoing Banded Sleeve Gastrectomy: A Prospective Clinical Study

    PubMed Central

    Miguel, Gustavo Peixoto Soares; Azevedo, Joao Luiz Moreira Coutinho; Neto, Carlos Gicovate; Moreira, Cora Lavigne Castelo Branco; Viana, Elaine Cristina; Carvalho, Perseu Seixas

    2009-01-01

    OBJECTIVE To assess glucose homeostasis and weight loss in morbidly obese patients undergoing Silastic® ring sleeve gas-trectomy. METHODS This was a prospective clinical study. Thirty-three female patients with a mean body mass index (BMI) of 42.33 ± 1.50 kg/m2 (range: 40–45 kg/m2), a mean age of 36.7 ± 9.4 years and a mean waist circumference of 118.7 ± 5.98 cm were included in this study. Type 2 diabetes mellitus was observed in 11 patients (33.3%), and glucose intolerance was observed in 4 patients (12.1%). Mean plasma fasting glucose levels were 109.77 ± 44.19 mg/dl (75–320) in the preoperative period. All Silastic® ring sleeve gastrectomy procedures were performed by the same surgical team using the same anesthetic technique. The patients were monitored for at least 12 months after surgery. RESULTS The mean weight of the patients decreased from 107.69 ± 6.57 kg to 70.52 ± 9.36 kg (p < 0.001), the mean BMI decreased to 27.4 ± 2.42 kg/m2 (p < 0.001), and the mean waist circumference decreased to 89.87 cm ± 6.66 (p < 0.001) in the postoperative period. Excess BMI loss was 86.5 ± 14.2%. Fasting glucose levels were reduced to 80.94 ± 6.3 mg/dl (p < 0.001). Remission of diabetes and glucose intolerance was observed in all patients. CONCLUSION Silastic® ring sleeve gastrectomy was effective in promoting weight loss, waist circumference reduction and control of glucose homeostasis in morbidly obese patients. PMID:19936183

  1. Identification of non-random sequence properties in groups of signature peptides obtained in random sequence peptide microarray experiments.

    PubMed

    Kuznetsov, Igor B

    2016-05-01

    Immunosignaturing is an emerging experimental technique that uses random sequence peptide microarrays to detect antibodies produced by the immune system in response to a particular disease. Two important questions regarding immunosignaturing are "Do microarray peptides that exhibit a strong affinity to a given type of antibodies share common sequence properties?" and "If so, what are those properties?" In this work, three statistical tests designed to detect non-random patterns in the amino acid makeup of a group of microarray peptides are presented. One test detects patterns of significantly biased amino acid usage, whereas the other two detect patterns of significant bias in the biochemical properties. These tests do not require a large number of peptides per group. The tests were applied to analyze 19 groups of peptides identified in immunosignaturing experiments as being specific for antibodies produced in response to various types of cancer and other diseases. The positional distribution of the biochemical properties of the amino acids in these 19 peptide groups was also studied. Remarkably, despite the random nature of the sequence libraries used to design the microarrays, a unique group-specific non-random pattern was identified in the majority of the peptide groups studied. © 2016 Wiley Periodicals, Inc. Biopolymers (Pept Sci) 106: 318-329, 2016. PMID:27037995

  2. Comparing the hydrosurgery system to conventional debridement techniques for the treatment of delayed healing wounds: a prospective, randomised clinical trial to investigate clinical efficacy and cost-effectiveness.

    PubMed

    Liu, Jing; Ko, Jason H; Secretov, Erwin; Huang, Eric; Chukwu, Christiana; West, Julie; Piserchia, Katherine; Galiano, Robert D

    2015-08-01

    In these uncertain times of high health care costs, clinicians are looking for cost-effective devices to employ in their everyday practices. In an effort to promote cost-effective and proper wound repair, the hydrosurgical device allows accurate debridement of only unwanted tissue while precisely conserving viable structures for eventual repair. This prospective, randomised study compared procedures using the hydrosurgery system (VERSAJET™) with conventional debridement in order to assess clinical efficacy and cost-effectiveness when treating subjects with chronic wounds. A total of 40 subjects were recruited. There was no difference in time to achieve stable wound closure between the treatment groups (P = 0·77). There were no significant differences between the two groups in terms of cost of the first operative procedure (P = 0·28), cost of surgical procedures during the study (P = 0·51), cost of study treatment (P = 0·29) or cost to achieve stable wound closure (P = 0·85). There were no differences in quantitative bacterial counts after debridement with either methods (P = 0·376). However, the time taken for the first excision procedure was significantly faster using the hydrosurgery system (VERSAJET) when compared with conventional debridement (P < 0·001). The total excision time for all procedures was significantly less for the Hydrosurgery group than for the conventional group (P = 0·005). Also, the Hydrosurgery group demonstrated significantly less intraoperative blood loss than conventional group for all procedures (P = 0·003). In this study, although there were no differences in time to stable wound closure or bacterial reduction between the two groups, the hydrosurgery system (VERSAJET) did offer advantages in terms of operative times and intraoperative blood loss and was cost-neutral, despite the handpiece cost.

  3. Sequential algorithm analysis to facilitate selective biliary access for difficult biliary cannulation in ERCP: a prospective clinical study

    PubMed Central

    2014-01-01

    Background Numerous clinical trials to improve the success rate of biliary access in difficult biliary cannulation (DBC) during ERCP have been reported. However, standard guidelines or sequential protocol analysis according to different methods are limited in place. We planned to investigate a sequential protocol to facilitate selective biliary access for DBC during ERCP. Methods This prospective clinical study enrolled 711 patients with naïve papillae at a tertiary referral center. If wire-guided cannulation was deemed to have failed due to the DBC criteria, then according to the cannulation algorithm early precut fistulotomy (EPF; cannulation time > 5 min, papillary contacts > 5 times, or hook-nose-shaped papilla), double-guidewire cannulation (DGC; unintentional pancreatic duct cannulation ≥ 3 times), and precut after placement of a pancreatic stent (PPS; if DGC was difficult or failed) were performed sequentially. The main outcome measurements were the technical success, procedure outcomes, and complications. Results Initially, a total of 140 (19.7%) patients with DBC underwent EPF (n = 71) and DGC (n = 69). Then, in DGC group 36 patients switched to PPS due to difficulty criteria. The successful biliary cannulation rate was 97.1% (136/140; 94.4% [67/71] with EPF, 47.8% [33/69] with DGC, and 100% [36/36] with PPS; P < 0.001). The mean successful cannulation time (standard deviation) was 559.4 (412.8) seconds in EPF, 314.8 (65.2) seconds in DGC, and 706.0 (469.4) seconds in PPS (P < 0.05). The DGC group had a relatively low successful cannulation rate (47.8%) but had a shorter cannulation time compared to the other groups due to early switching to the PPS method in difficult or failed DGC. Post-ERCP pancreatitis developed in 14 (10%) patients (9 mild, 1 moderate), which did not differ significantly among the groups (P = 0.870) or compared with the conventional group (P = 0.125). Conclusions Based on the sequential protocol

  4. Impact of outpatient clinic ultrasound imaging in the diagnosis and treatment for shoulder impingement: a randomized prospective study.

    PubMed

    Saeed, Aamir; Khan, Mumtaz; Morrissey, Siobhan; Kane, David; Fraser, Alexander Duncan

    2014-04-01

    The use of musculoskeletal ultrasonography (MSUS) in guiding subdeltoid injection has been shown to improve outcome up to 6 weeks in a few small studies. A recent meta-analysis identified the need for further studies with longer-term outcome and larger sample size. This randomized prospective study assessed whether clinic-based MSUS can significantly improve diagnostic accuracy in shoulder pain and whether MSUS-guided shoulder injection results in improved long-term outcomes. One hundred consecutive patients with 125 painful shoulders were recruited. Patients were randomized to receive either sonographic assessment with consequent palpation-guided injection (Group 1, n = 66) or sonographic assessment with a MSUS-guided injection of 40 mg of methylprednisolone acetate (Group 2, n = 59). A blinded rheumatologist (ADF) performed clinical assessments at baseline, 6 and 12 weeks including shoulder function tests (SFTs) (Hawkins-Kennedy test, supraspinatus tendon tenderness), physician global assessment (PGA) and patient visual analogue scores (VAS) for pain (0-10). Eighty patients with 90 symptomatic shoulders completed 12-week follow-up. Twenty patients, 11 (20 shoulders) from the palpation-guided group and 9 (15 shoulders) from the MSUS-guided group, were excluded at 6 weeks either due to requirement for repeat injection or due to surgical referral. Mean age for patients was 57.7 years, and 65 % patients were female; mean shoulder pain duration was 18 weeks (range 14-22 weeks). SFTs, patient VAS and PGA scores for pain improved significantly from baseline in both groups with significantly greater improvements in the MSUS-guided group (44 shoulders) compared to the palpation-guided group (46 shoulders) in all parameters at 6 (p < 0.01) and 12 weeks (p < 0.05). The use of MSUS in guiding subdeltoid injection has been shown to improve outcome up to 6 weeks in a few small studies. A recent meta-analysis identified the need for further studies with longer-term outcome and

  5. Comparison of F(ab')2 versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trial

    PubMed Central

    Ruha, Anne-Michelle; Seifert, Steven A.; Morgan, David L.; Lewis, Brandon J.; Arnold, Thomas C.; Clark, Richard F.; Meggs, William J.; Toschlog, Eric A.; Borron, Stephen W.; Figge, Gary R.; Sollee, Dawn R.; Shirazi, Farshad M.; Wolk, Robert; de Chazal, Ives; Quan, Dan; García-Ubbelohde, Walter; Alagón, Alejandro; Gerkin, Richard D.; Boyer, Leslie V.

    2015-01-01

    Background. Crotalidae Polyvalent Immune Fab (Ovine) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation. Late coagulopathy can occur or recur after clearance of Fab antivenom, often after hospital discharge, lasting in some cases more than 2 weeks. There have been serious, even fatal, bleeding complications associated with recurrence phenomena. Frequent follow-up is required, and additional intervention or hospitalization is often necessary. F(ab')2 immunoglobulin derivatives have longer plasma half life than do Fab. We hypothesized that F(ab')2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation. Methods. We conducted a prospective, double-blind, randomized clinical trial, comparing late coagulopathy in snakebitten patients treated with F(ab')2 with maintenance doses [F(ab')2/F(ab')2], or F(ab')2 with placebo maintenance doses [F(ab')2/placebo], versus Fab with maintenance doses [Fab/Fab]. The primary efficacy endpoint was coagulopathy (platelet count < 150 K/mm3, fibrinogen level < 150 mg/dL) between end of maintenance dosing and day 8. Results. 121 patients were randomized at 18 clinical sites and received at least one dose of study drug. 114 completed the study. Of these, 11/37 (29.7%) in the Fab/Fab cohort experienced late coagulopathy versus 4/39 (10.3%, p < 0.05) in the F(ab')2/F(ab')2 cohort and 2/38 (5.3%, p < 0.05) in the F(ab')2/placebo cohort. The lowest heterologous protein exposure was with F(ab')2/placebo. No serious adverse events were related to study drug. In each study arm, one patient experienced an acute serum reaction and one experienced serum sickness. Conclusions. In this study, management of coagulopathic Crotalinae envenomation with longer-half-life F(ab')2 antivenom, with or without maintenance dosing, reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation

  6. Rectal biopsy for diagnosis of intestinal neuronal dysplasia in children: a prospective multicentre study on interobserver variation and clinical outcome

    PubMed Central

    Koletzko, S; Jesch, I; Faus-Kessler, T; Briner, J; Meier-Ruge, W; Muntefering, H; Coerdt, W; Wessel, L; Keller, K; Nutzenadel, W; Schmittenbecher, P; Holschneider, A; Sacher, P

    1999-01-01

    BACKGROUND—Intestinal neuronal dysplasia (IND) of the colonic submucous plexus is considered to be a congenital malformation of the enteric nervous system causing symptoms resembling those of Hirschsprung's disease. In contrast with the established diagnosis of aganglionosis using enzyme histochemistry, controversy exists over the diagnostic criteria of IND on rectal biopsies previously defined by a consensus report and the causal relation between morphological findings and clinical symptoms.
AIMS—The interobserver variability was prospectively investigated with respect to final diagnoses and several histological features in rectal biopsy specimens from children suspected of having colonic motility disturbances.
METHODS—377 biopsy specimens from 108 children aged 4 days to 15 years were independently coded without knowledge of clinical symptoms by three experienced pathologists for 20 histological features, and a final diagnosis was given for every case. Interobserver variation for the different items and the final diagnosis were analysed using Cohen's κ statistic. Clinical data at biopsy and outcome after 12 months were related to morphological findings.
RESULTS—The three pathologists agreed completely with respect to the diagnosis Hirschsprung's disease (κ = 1), but in only 14% of the children without aganglionosis. In 15 (17%) of the 87 children without aganglionosis, at least one pathologist judged the case as normal, while another diagnosed IND. κ values were close to the zero value expected by chance for the diagnoses normal and IND. Young age was related to the presence of several morphological features—for example, acetylcholine esterase staining and presence of giant ganglia. Children with chronic constipation diagnosed as having IND, given no other specific diagnosis by any of the pathologists, were significantly younger (median 8.8 months) and had a higher cure rate after one year (60%) than constipated patients considered

  7. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation

    PubMed Central

    Webster, Craig S; Hannam, Jacqueline; Mitchell, Simon J; Henderson, Robert; Reid, Papaarangi; Edwards, Kylie-Ellen; Jardim, Anisoara; Pak, Nick; Cooper, Jeremy; Hopley, Lara; Frampton, Chris; Short, Timothy G

    2011-01-01

    Objective To clinically evaluate a new patented multimodal system (SAFERSleep) designed to reduce errors in the recording and administration of drugs in anaesthesia. Design Prospective randomised open label clinical trial. Setting Five designated operating theatres in a major tertiary referral hospital. Participants Eighty nine consenting anaesthetists managing 1075 cases in which there were 10 764 drug administrations. Intervention Use of the new system (which includes customised drug trays and purpose designed drug trolley drawers to promote a well organised anaesthetic workspace and aseptic technique; pre-filled syringes for commonly used anaesthetic drugs; large legible colour coded drug labels; a barcode reader linked to a computer, speakers, and touch screen to provide automatic auditory and visual verification of selected drugs immediately before each administration; automatic compilation of an anaesthetic record; an on-screen and audible warning if an antibiotic has not been administered within 15 minutes of the start of anaesthesia; and certain procedural rules—notably, scanning the label before each drug administration) versus conventional practice in drug administration with a manually compiled anaesthetic record. Main outcome measures Primary: composite of errors in the recording and administration of intravenous drugs detected by direct observation and by detailed reconciliation of the contents of used drug vials against recorded administrations; and lapses in responding to an intermittent visual stimulus (vigilance latency task). Secondary: outcomes in patients; analyses of anaesthetists’ tasks and assessments of workload; evaluation of the legibility of anaesthetic records; evaluation of compliance with the procedural rules of the new system; and questionnaire based ratings of the respective systems by participants. Results The overall mean rate of drug errors per 100 administrations was 9.1 (95% confidence interval 6.9 to 11.4) with the new

  8. Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee – A Comparison of Randomised and Non-Randomised Studies

    PubMed Central

    Oeller, Patrick; Kasenda, Benjamin; Briel, Matthias; von Elm, Erik

    2016-01-01

    Background Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs) which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs) is yet unclear. Objectives To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval. Methods We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why. Results Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs). NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14%) versus 78/288 (27%, p<0.001, missing data excluded). Poor recruitment was the most frequent reason for discontinuation in both NPSs (36%) and RCTs (37%). Conclusions Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs. PMID:27792749

  9. Non-random inactivation of large common fragile site genes in different cancers.

    PubMed

    McAvoy, S; Ganapathiraju, S C; Ducharme-Smith, A L; Pritchett, J R; Kosari, F; Perez, D S; Zhu, Y; James, C D; Smith, D I

    2007-01-01

    The common fragile sites are regions of profound genomic instability found in all individuals. The full size of each region of instability ranges from under one megabase (Mb) to greater than 10 Mbs. At least half of the CFS regions have been found to span extremely large genes that spanned from 600 kb to greater than 2.0 Mbs. The large CFS genes are also very interesting from a cancer perspective as several of them, including FHIT and WWOX, have already demonstrated the capacity to function as tumor suppressor genes, both in vitro and in vivo. We estimate that there may be 40-50 large genes localized in CFS regions. The expression of a number of the large CFS genes has been previously shown to be lost in many different cancers and this is frequently associated with a worse clinical outcome for patients. To determine if there was selection for the inactivation of different large CFS genes in different cancers, we examined the expression of 13 of the 20 known large CFS genes: FHIT, WWOX, PARK2, GRID2, NBEA, DLG2, RORA isoforms 1 and 4, DAB1, CNTNAP2, DMD, IL1RAPL1, IMMP2L and LARGE in breast, ovarian, endometrial and brain cancers using real-time RT-PCR analysis. Each cancer had a distinct profile of different large CFS genes that were inactivated. Interestingly, in breast, ovarian and endometrial cancers there were some cancers that had inactivation of expression of none or only one of the tested genes, while in other specimens there was inactivation of multiple tested genes. Brain cancers had inactivation of many of the tested genes, a number of which function in normal neurological development. We find that there is no relationship between the frequency that any specific CFS is expressed and the frequency that the gene from that region is inactivated in different cancers. Instead, it appears that different cancers select for the inactivation of different large CFS genes.

  10. Clinical effects of lateral wedge arch support insoles in knee osteoarthritis: A prospective double-blind randomized study.

    PubMed

    Hsieh, Ru-Lan; Lee, Wen-Chung

    2016-07-01

    We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function

  11. Clinical effects of lateral wedge arch support insoles in knee osteoarthritis: A prospective double-blind randomized study.

    PubMed

    Hsieh, Ru-Lan; Lee, Wen-Chung

    2016-07-01

    We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function

  12. Clinical features and predictors for disease natural progression in adults with Pompe disease: a nationwide prospective observational study

    PubMed Central

    2012-01-01

    Background Due partly to physicians’ unawareness, many adults with Pompe disease are diagnosed with great delay. Besides, it is not well known which factors influence the rate of disease progression, and thus disease outcome. We delineated the specific clinical features of Pompe disease in adults, and mapped out the distribution and severity of muscle weakness, and the sequence of involvement of the individual muscle groups. Furthermore, we defined the natural disease course and identified prognostic factors for disease progression. Methods We conducted a single-center, prospective, observational study. Muscle strength (manual muscle testing, and hand-held dynamometry), muscle function (quick motor function test), and pulmonary function (forced vital capacity in sitting and supine positions) were assessed every 3–6 months and analyzed using repeated-measures ANOVA. Results Between October 2004 and August 2009, 94 patients aged between 25 and 75 years were included in the study. Although skeletal muscle weakness was typically distributed in a limb-girdle pattern, many patients had unfamiliar features such as ptosis (23%), bulbar weakness (28%), and scapular winging (33%). During follow-up (average 1.6 years, range 0.5-4.2 years), skeletal muscle strength deteriorated significantly (mean declines of −1.3% point/year for manual muscle testing and of −2.6% points/year for hand-held dynamometry; both p<0.001). Longer disease duration (>15 years) and pulmonary involvement (forced vital capacity in sitting position <80%) at study entry predicted faster decline. On average, forced vital capacity in supine position deteriorated by 1.3% points per year (p=0.02). Decline in pulmonary function was consistent across subgroups. Ten percent of patients declined unexpectedly fast. Conclusions Recognizing patterns of common and less familiar characteristics in adults with Pompe disease facilitates timely diagnosis. Longer disease duration and reduced pulmonary function

  13. The Origin of Aging: Imperfectness-Driven Non-Random Damage Defines the Aging Process and Control of Lifespan

    PubMed Central

    Gladyshev, Vadim N.

    2013-01-01

    Physico-chemical properties preclude ideal biomolecules and perfect biological functions. This inherent imperfectness leads to the generation of damage by every biological process, at all levels, from small molecules to cells. The damage is too numerous to be repaired, is partially invisible to natural selection and manifests as aging. I propose that it is the inherent imperfectness of biological systems that is the true root of the aging process. As each biomolecule generates specific forms of damage, the cumulative damage is largely non-random and is indirectly encoded in the genome. I consider this concept in light of other proposed theories of aging and integrate these disparate ideas into a single model. I also discuss the evolutionary significance of damage accumulation and strategies for reducing damage. Finally, I suggest ways to test this integrated model of aging. PMID:23769208

  14. The clinical assessment study of the foot (CASF): study protocol for a prospective observational study of foot pain and foot osteoarthritis in the general population

    PubMed Central

    2011-01-01

    Background Symptomatic osteoarthritis (OA) affects approximately 10% of adults aged over 60 years. The foot joint complex is commonly affected by OA, yet there is relatively little research into OA of the foot, compared with other frequently affected sites such as the knee and hand. Existing epidemiological studies of foot OA have focussed predominantly on the first metatarsophalangeal joint at the expense of other joints. This three-year prospective population-based observational cohort study will describe the prevalence of symptomatic radiographic foot OA, relate its occurrence to symptoms, examination findings and life-style-factors, describe the natural history of foot OA, and examine how it presents to, and is diagnosed and managed in primary care. Methods All adults aged 50 years and over registered with four general practices in North Staffordshire, UK, will be invited to participate in a postal Health Survey questionnaire. Respondents to the questionnaire who indicate that they have experienced foot pain in the preceding twelve months will be invited to attend a research clinic for a detailed clinical assessment. This assessment will consist of: clinical interview; physical examination; digital photography of both feet and ankles; plain x-rays of both feet, ankles and hands; ultrasound examination of the plantar fascia; anthropometric measurement; and a further self-complete questionnaire. Follow-up will be undertaken in consenting participants by postal questionnaire at 18 months (clinic attenders only) and three years (clinic attenders and survey participants), and also by review of medical records. Discussion This three-year prospective epidemiological study will combine survey data, comprehensive clinical, x-ray and ultrasound assessment, and review of primary care records to identify radiographic phenotypes of foot OA in a population of community-dwelling older adults, and describe their impact on symptoms, function and clinical examination findings

  15. Clinical outcomes of patients requiring ventilatory support in Brazilian intensive care units: a multicenter, prospective, cohort study

    PubMed Central

    2013-01-01

    Introduction Contemporary information on mechanical ventilation (MV) use in emerging countries is limited. Moreover, most epidemiological studies on ventilatory support were carried out before significant developments, such as lung protective ventilation or broader application of non-invasive ventilation (NIV). We aimed to evaluate the clinical characteristics, outcomes and risk factors for hospital mortality and failure of NIV in patients requiring ventilatory support in Brazilian intensive care units (ICU). Methods In a multicenter, prospective, cohort study, a total of 773 adult patients admitted to 45 ICUs over a two-month period requiring invasive ventilation or NIV for more than 24 hours were evaluated. Causes of ventilatory support, prior chronic health status and physiological data were assessed. Multivariate analysis was used to identifiy variables associated with hospital mortality and NIV failure. Results Invasive MV and NIV were used as initial ventilatory support in 622 (80%) and 151 (20%) patients. Failure with subsequent intubation occurred in 54% of NIV patients. The main reasons for ventilatory support were pneumonia (27%), neurologic disorders (19%) and non-pulmonary sepsis (12%). ICU and hospital mortality rates were 34% and 42%. Using the Berlin definition, acute respiratory distress syndrome (ARDS) was diagnosed in 31% of the patients with a hospital mortality of 52%. In the multivariate analysis, age (odds ratio (OR), 1.03; 95% confidence interval (CI), 1.01 to 1.03), comorbidities (OR, 2.30; 95% CI, 1.28 to 3.17), associated organ failures (OR, 1.12; 95% CI, 1.05 to 1.20), moderate (OR, 1.92; 95% CI, 1.10 to 3.35) to severe ARDS (OR, 2.12; 95% CI, 1.01 to 4.41), cumulative fluid balance over the first 72 h of ICU (OR, 2.44; 95% CI, 1.39 to 4.28), higher lactate (OR, 1.78; 95% CI, 1.27 to 2.50), invasive MV (OR, 2.67; 95% CI, 1.32 to 5.39) and NIV failure (OR, 3.95; 95% CI, 1.74 to 8.99) were independently associated with hospital mortality

  16. Changing clinical and biological manifestations of dengue during the dengue-2 epidemic in French Polynesia in 1996/97--description and analysis in a prospective study.

    PubMed

    Deparis, X; Murgue, B; Roche, C; Cassar, O; Chungue, E

    1998-11-01

    In August 1996 dengue-2 virus was detected in French Polynesia for the first time since 1976. A prospective study was conducted from November 1996 to April 1997. Each time one of 7 physicians suspected dengue, the patient was enrolled and epidemiological, clinical and biological data were recorded. Dengue diagnosis was confirmed by virus isolation and IgM detection. The aims of this study were to find clinical and biological predictive factors constituting a specific profile of dengue (DF) and dengue haemorrhagic fever (DHF/DSS) and to assess the possibility of diagnosing dengue at primary health care level using clinical criteria and basic laboratory parameters. Of 298 clinically suspect cases, 196 (66%) were confirmed as dengue. The association of macular rash, pruritus, low platelet count and leukopenia was statistically predictive of dengue but not clinically, since these four signs occur in many other viral infections. As the prevalence of clinical and biological manifestations varied over time in our study, a specific profile useful for dengue diagnosis cannot be defined. With six cases of DHF, the morbidity of this dengue-2 outbreak was very low despite the sequential infection scheme DEN-3/DEN-2. The clinical expression of dengue could depend on a specific virus strain circulating in a specific population in a particular place, with varying virulence over time.

  17. Fully Automated Simultaneous Integrated Boosted-Intensity Modulated Radiation Therapy Treatment Planning Is Feasible for Head-and-Neck Cancer: A Prospective Clinical Study

    SciTech Connect

    Wu Binbin; McNutt, Todd; Zahurak, Marianna; Simari, Patricio; Pang, Dalong; Taylor, Russell; Sanguineti, Giuseppe

    2012-12-01

    Purpose: To prospectively determine whether overlap volume histogram (OVH)-driven, automated simultaneous integrated boosted (SIB)-intensity-modulated radiation therapy (IMRT) treatment planning for head-and-neck cancer can be implemented in clinics. Methods and Materials: A prospective study was designed to compare fully automated plans (APs) created by an OVH-driven, automated planning application with clinical plans (CPs) created by dosimetrists in a 3-dose-level (70 Gy, 63 Gy, and 58.1 Gy), head-and-neck SIB-IMRT planning. Because primary organ sparing (cord, brain, brainstem, mandible, and optic nerve/chiasm) always received the highest priority in clinical planning, the study aimed to show the noninferiority of APs with respect to PTV coverage and secondary organ sparing (parotid, brachial plexus, esophagus, larynx, inner ear, and oral mucosa). The sample size was determined a priori by a superiority hypothesis test that had 85% power to detect a 4% dose decrease in secondary organ sparing with a 2-sided alpha level of 0.05. A generalized estimating equation (GEE) regression model was used for statistical comparison. Results: Forty consecutive patients were accrued from July to December 2010. GEE analysis indicated that in APs, overall average dose to the secondary organs was reduced by 1.16 (95% CI = 0.09-2.33) with P=.04, overall average PTV coverage was increased by 0.26% (95% CI = 0.06-0.47) with P=.02 and overall average dose to the primary organs was reduced by 1.14 Gy (95% CI = 0.45-1.8) with P=.004. A physician determined that all APs could be delivered to patients, and APs were clinically superior in 27 of 40 cases. Conclusions: The application can be implemented in clinics as a fast, reliable, and consistent way of generating plans that need only minor adjustments to meet specific clinical needs.

  18. Emotional Reasoning and Parent-Based Reasoning in Non-Clinical Children, and Their Prospective Relationships with Anxiety Symptoms

    ERIC Educational Resources Information Center

    Morren, Mattijn; Muris, Peter; Kindt, Merel; Schouten, Erik; van den Hout, Marcel

    2008-01-01

    Emotional and parent-based reasoning refer to the tendency to rely on personal or parental anxiety response information rather than on objective danger information when estimating the dangerousness of a situation. This study investigated the prospective relationships of emotional and parent-based reasoning with anxiety symptoms in a sample of…

  19. Five-year results of a prospective randomised controlled clinical trial of posterior computer-aided design-computer-aided manufacturing ZrSiO4 -ceramic crowns.

    PubMed

    Passia, N; Stampf, S; Strub, J R

    2013-08-01

    The aim of this prospective randomised controlled clinical trial was to evaluate the clinical outcome of shrinkage-free ZrSiO4 -ceramic full-coverage crowns on premolars and molars in comparison with conventional gold crowns over a 5-year period. Two hundred and twenty-three patients were included and randomly divided into two treatment groups. One hundred and twenty-three patients were restored with 123 ZrSiO4 -ceramic crowns, and 100 patients received 100 gold crowns, which served as the control. All crowns were conventionally cemented with glass-ionomer cement. After an observation period of 6, 12, 24, 36, 48 and 60 months, the survival probability (Kaplan-Meier) for the shrinkage-free ZrSiO4 -ceramic crowns was 98·3%, 92·0%, 84·7%, 79% and 73·2% and for the gold crowns, 99%, 97·9%, 95·7%, 94·6% and 92·3%, respectively. The difference between the test and control group was statistically significant (P = 0·0027). The gold crowns showed a better marginal integrity with less marginal discoloration than the ceramic crowns. The most common failure in the ceramic crown group was fracture of the crown. The 60-month results of this prospective randomised controlled clinical trial suggest that the use of these shrinkage-free ZrSiO4 -ceramic crowns in posterior tooth restorations cannot be recommended.

  20. Prospective evaluation of a hydrogel spacer for rectal separation in dose-escalated intensity-modulated radiotherapy for clinically localized prostate cancer

    PubMed Central

    2013-01-01

    Background As dose-escalation in prostate cancer radiotherapy improves cure rates, a major concern is rectal toxicity. We prospectively assessed an innovative approach of hydrogel injection between prostate and rectum to reduce the radiation dose to the rectum and thus side effects in dose-escalated prostate radiotherapy. Methods Acute toxicity and planning parameters were prospectively evaluated in patients with T1-2 N0 M0 prostate cancer receiving dose-escalated radiotherapy after injection of a hydrogel spacer. Before and after hydrogel injection, we performed MRI scans for anatomical assessment of rectal separation. Radiotherapy was planned and administered to 78 Gy in 39 fractions. Results From eleven patients scheduled for spacer injection the procedure could be performed in ten. In one patient hydrodissection of the Denonvillier space was not possible. Radiation treatment planning showed low rectal doses despite dose-escalation to the target. In accordance with this, acute rectal toxicity was mild without grade 2 events and there was complete resolution within four to twelve weeks. Conclusions This prospective study suggests that hydrogel injection is feasible and may prevent rectal toxicity in dose-escalated radiotherapy of prostate cancer. Further evaluation is necessary including the definition of patients who might benefit from this approach. Trial registration: German Clinical Trials Register DRKS00003273. PMID:23336502

  1. Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases: Rationale, Aims, and Design of a Nationwide Prospective Registry--The EXCITING-ILD Registry.

    PubMed

    Kreuter, Michael; Herth, Felix J F; Wacker, Margarethe; Leidl, Reiner; Hellmann, Andreas; Pfeifer, Michael; Behr, Jürgen; Witt, Sabine; Kauschka, Dagmar; Mall, Marcus; Günther, Andreas; Markart, Philipp

    2015-01-01

    Despite a number of prospective registries conducted in past years, the current epidemiology of interstitial lung diseases (ILD) is still not well defined, particularly regarding the prevalence and incidence, their management, healthcare utilisation needs, and healthcare-associated costs. To address these issues in Germany, a new prospective ILD registry, "Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases" (EXCITING-ILD), is being conducted by the German Centre for Lung Research in association with ambulatory, inpatient, scientific pulmonology organisations and patient support groups. This multicentre, noninterventional, prospective, and observational ILD registry aims to collect comprehensive and validated data from all healthcare institutions on the incidence, prevalence, characteristics, management, and outcomes regarding all ILD presentations in the real-world setting. Specifically, this registry will collect demographic data, disease-related data such as ILD subtype, treatments, diagnostic procedures (e.g., HRCT, surgical lung biopsy), risk factors (e.g., familial ILD), significant comorbidities, ILD managements, and disease outcomes as well as healthcare resource consumption. The EXCITING-ILD registry will include in-patient and out-patient ILD healthcare facilities in more than 100 sites. In summary, this registry will document comprehensive and current epidemiological data as well as important health economic data for ILDs in Germany. PMID:26640781

  2. Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases: Rationale, Aims, and Design of a Nationwide Prospective Registry—The EXCITING-ILD Registry

    PubMed Central

    Kreuter, Michael; Herth, Felix J. F.; Wacker, Margarethe; Leidl, Reiner; Hellmann, Andreas; Pfeifer, Michael; Behr, Jürgen; Witt, Sabine; Kauschka, Dagmar; Mall, Marcus; Günther, Andreas; Markart, Philipp

    2015-01-01

    Despite a number of prospective registries conducted in past years, the current epidemiology of interstitial lung diseases (ILD) is still not well defined, particularly regarding the prevalence and incidence, their management, healthcare utilisation needs, and healthcare-associated costs. To address these issues in Germany, a new prospective ILD registry, “Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases” (EXCITING-ILD), is being conducted by the German Centre for Lung Research in association with ambulatory, inpatient, scientific pulmonology organisations and patient support groups. This multicentre, noninterventional, prospective, and observational ILD registry aims to collect comprehensive and validated data from all healthcare institutions on the incidence, prevalence, characteristics, management, and outcomes regarding all ILD presentations in the real-world setting. Specifically, this registry will collect demographic data, disease-related data such as ILD subtype, treatments, diagnostic procedures (e.g., HRCT, surgical lung biopsy), risk factors (e.g., familial ILD), significant comorbidities, ILD managements, and disease outcomes as well as healthcare resource consumption. The EXCITING-ILD registry will include in-patient and out-patient ILD healthcare facilities in more than 100 sites. In summary, this registry will document comprehensive and current epidemiological data as well as important health economic data for ILDs in Germany. PMID:26640781

  3. Evaluation of the Efficacy and Safety of Short-Course Deep Sedation Therapy for the Treatment of Intracerebral Hemorrhage After Surgery: A Non-Randomized Control Study

    PubMed Central

    Hou, Dapeng; Liu, Beibei; Zhang, Juan; Wang, Qiushi; Zheng, Wei

    2016-01-01

    Background While mild and moderate sedation have been widely used to reduce sudden agitation in intracerebral hemorrhage (ICH) patients after surgery, agitation is still a frequent problem, which may cause postoperative blood pressure fluctuation. The present study aimed to evaluate the efficacy and safety of short-course deep sedation for the treatment of ICH after surgery. Material/Methods A total of 41 ICH patients who received surgery, including traditional craniotomy hematoma removal and decompressive craniectomy, were including in this non-randomized control study. Patients in the deep sedation group received continuous postoperative sedation with a target course for ≤12 hours and reached SAS scores of 1~2. Patients in the traditional sedition group received continuous light sedation and reached SAS scores of 3~4. Additional therapeutic interventions included antihypertensive treatment, mechanical ventilation, tracheotomy, and re-operation. Results Patients in the deep sedation group had deeper sedation degree, and lower systolic blood pressure (SBP) and diastolic blood pressure (DBP). Residual hematoma after surgery in patients in the deep sedation group were smaller on the second, seventh, and fourteenth day after surgery (p=0.023, 0.003, 0.004, respectively). The 3-month mortality and quality of life of patients in the deep sedation group were lower and better than that of patients in the traditional sedation group, respectively (p=0.044, p<0.01). No significant difference in the incidence of ventilator-associated pneumonia (VAP) and ICU days were observed between the two groups. Conclusions Short-course deep sedation therapy in ICH patients after surgery is efficient in controlling postoperative blood pressure, reducing re-bleeding, and improving clinical prognosis. PMID:27466863

  4. Evaluation of the Efficacy and Safety of Short-Course Deep Sedation Therapy for the Treatment of Intracerebral Hemorrhage After Surgery: A Non-Randomized Control Study.

    PubMed

    Hou, Dapeng; Liu, Beibei; Zhang, Juan; Wang, Qiushi; Zheng, Wei

    2016-01-01

    BACKGROUND While mild and moderate sedation have been widely used to reduce sudden agitation in intracerebral hemorrhage (ICH) patients after surgery, agitation is still a frequent problem, which may cause postoperative blood pressure fluctuation. The present study aimed to evaluate the efficacy and safety of short-course deep sedation for the treatment of ICH after surgery. MATERIAL AND METHODS A total of 41 ICH patients who received surgery, including traditional craniotomy hematoma removal and decompressive craniectomy, were including in this non-randomized control study. Patients in the deep sedation group received continuous postoperative sedation with a target course for ≤12 hours and reached SAS scores of 1~2. Patients in the traditional sedition group received continuous light sedation and reached SAS scores of 3~4. Additional therapeutic interventions included antihypertensive treatment, mechanical ventilation, tracheotomy, and re-operation. RESULTS Patients in the deep sedation group had deeper sedation degree, and lower systolic blood pressure (SBP) and diastolic blood pressure (DBP). Residual hematoma after surgery in patients in the deep sedation group were smaller on the second, seventh, and fourteenth day after surgery (p=0.023, 0.003, 0.004, respectively). The 3-month mortality and quality of life of patients in the deep sedation group were lower and better than that of patients in the traditional sedation group, respectively (p=0.044, p<0.01). No significant difference in the incidence of ventilator-associated pneumonia (VAP) and ICU days were observed between the two groups. CONCLUSIONS Short-course deep sedation therapy in ICH patients after surgery is efficient in controlling postoperative blood pressure, reducing re-bleeding, and improving clinical prognosis.

  5. Randomly and Non-Randomly Missing Renal Function Data in the Strong Heart Study: A Comparison of Imputation Methods.

    PubMed

    Shara, Nawar; Yassin, Sayf A; Valaitis, Eduardas; Wang, Hong; Howard, Barbara V; Wang, Wenyu; Lee, Elisa T; Umans, Jason G

    2015-01-01

    Kidney and cardiovascular disease are widespread among populations with high prevalence of diabetes, such as American Indians participating in the Strong Heart Study (SHS). Studying these conditions simultaneously in longitudinal studies is challenging, because the morbidity and mortality associated with these diseases result in missing data, and these data are likely not missing at random. When such data are merely excluded, study findings may be compromised. In this article, a subset of 2264 participants with complete renal function data from Strong Heart Exams 1 (1989-1991), 2 (1993-1995), and 3 (1998-1999) was used to examine the performance of five methods used to impute missing data: listwise deletion, mean of serial measures, adjacent value, multiple imputation, and pattern-mixture. Three missing at random models and one non-missing at random model were used to compare the performance of the imputation techniques on randomly and non-randomly missing data. The pattern-mixture method was found to perform best for imputing renal function data that were not missing at random. Determining whether data are missing at random or not can help in choosing the imputation method that will provide the most accurate results.

  6. Does balneotherapy with low radon concentration in water influence the endocrine system? A controlled non-randomized pilot study.

    PubMed

    Nagy, Katalin; Berhés, István; Kovács, Tibor; Kávási, Norbert; Somlai, János; Bender, Tamás

    2009-08-01

    Radon bath is a well-established modality of balneotherapy for the management of degenerative musculoskeletal disorders. The present study was conducted to ascertain whether baths of relatively low (80 Bq/l) radon concentration have any influence on the functioning of the endocrine system. In the study, a non-randomized pilot study, 27 patients with degenerative musculoskeletal disorders received 30-min radon baths (of 31-32 degrees C temperature and 80 Bq/l average radon concentration) daily, for 15 days. Twenty-five patients with matching pathologies were subjected to balneotherapy according to the same protocol, using thermal water with negligible radon content (6 Bq/l). Serum thyroid stimulating hormone, prolactin, cortisol, adrenocorticotropic hormone, and dehydroepiandrosterone levels were measured before and after a balneotherapy course of 15 sessions. Comparison of the accumulated data using the Wilcoxon test did not reveal any significant difference between pre- and post-treatment values or between the two patient groups. It is noted that while the beneficial effects of balneotherapy with radon-containing water on degenerative disorders is widely known, only few data have been published in the literature on its effect on endocrine functions. The present study failed to demonstrate any substantial effect of thermal water with relatively low radon content on the functioning of the endocrine system.

  7. A polymerase chain reaction assay for non-random X chromosome inactivation identifies monoclonal endometrial cancers and precancers.

    PubMed

    Mutter, G L; Chaponot, M L; Fletcher, J A

    1995-02-01

    We hypothesize that endometrial carcinoma and their precursors share a monoclonal growth pattern and tested this thesis with archival paraffin-embedded tissues using a polymerase chain reaction-based assay for non-random X chromosome inactivation. Of the 10 well-differentiated endometrial adenocarcinoma cases with heterozygous markers (HUMARA, X-linked androgen receptor gene), 9 had skewed X inactivation consistent with a monoclonal process, and one contained a structurally altered HUMARA gene. X inactivation skewing similar to that of the tumor was seen in matched control polyclonal tissues of 4 (of 9) cases, caused by the small number of endometrial stem cells at the time of embryonic X inactivation. When the polymerase chain reaction assay was applied to four potential endometrial precancers (atypical endometrial hyperplasia) and matched control tissues, two were inconclusive, and two were found to be monoclonal. We conclude that 1) it is essential to include polyclonal control tissues in X inactivation analyses to determine whether skewing is a specific indicator of monoclonality; and 2) endometrial adenocarcinomas and some putative precancers, atypical endometrial hyperplasia, are monoclonal.

  8. Non-random cation distribution in hexagonal Al 0.5Ga 0.5PO 4

    NASA Astrophysics Data System (ADS)

    Kulshreshtha, S. K.; Jayakumar, O. D.; Sudarsan, V.

    2010-05-01

    Based on powder X-ray diffraction and 31P Magic Angle Spinning Nuclear Magnetic Resonance (MAS NMR) investigations of mixed phosphate Al 0.5Ga 0.5PO 4, prepared by co-precipitation method followed by annealing at 900 °C for 24 h, it is shown that Al 0.5Ga 0.5PO 4 phase crystallizes in hexagonal form with lattice parameter a=0.491(2) and c=1.106(4) nm. This hexagonal phase of Al 0.5Ga 0.5PO 4 is similar to that of pure GaPO 4. The 31P MAS NMR spectrum of the mixed phosphate sample consists of five peaks with systematic variation of their chemical shift values and is arising due to existence of P structural units having varying number of the Al 3+/Ga 3+ cations as the next nearest neighbors in the solid solution. Based on the intensity analysis of the component NMR spectra of Al 0.5Ga 0.5PO 4, it is inferred that the distribution of Al 3+ and Ga 3+ cations is non-random for the hexagonal Al 0.5Ga 0.5PO 4 sample although XRD patterns showed a well-defined solid solution formation.

  9. Using mobile phones to improve clinic attendance amongst an antiretroviral treatment cohort in rural Uganda: a cross-sectional and prospective study.

    PubMed

    Kunutsor, Setor; Walley, John; Katabira, Elly; Muchuro, Simon; Balidawa, Hudson; Namagala, Elizabeth; Ikoona, Eric

    2010-12-01

    We aimed to assess the patterns and dynamics of mobile phone usage amongst an antiretroviral treatment (ART) cohort in rural Uganda and ascertain its feasibility for improving clinic attendance. A cross-sectional study of clients on ART exploring their access to mobile phones and patterns of use was employed. Clinic attendances for antiretroviral drug refills were then monitored prospectively over 28 weeks in 176 patients identified in the cross-sectional survey who had access to mobile phones and had given consent to be contacted. Patients were contacted via voice calls or text messages to remind them about their missed clinic appointments. Of the 276 patients surveyed, 177 (64%) had access to mobile phones with all but one were willing to be contacted for missed visits reminders. Of the 560 total scheduled clinic appointments, 62 (11%) were missed visits. In 79% of episodes in which visits were missed, patients presented for treatment within a mean duration of 2.2 days (SD = 1.2 days) after mobile phone recall. Access to mobile phones was high in this setting. Privacy and confidentiality issues were not considered deterrents. Mobile phones have a potential for use in resource-constrained settings to substantially improve the clinical management of HIV/AIDS.

  10. Neonatal clinical screening of the hip in the diagnosis of developmental dysplasia of the hip: a 15-year prospective longitudinal observational study.

    PubMed

    Mace, J; Paton, R W

    2015-02-01

    Over a 15-year prospective period, 201 infants with a clinically unstable hip at neonatal screening were subsequently reviewed in a 'one stop' clinic where they were assessed clinically and sonographically. Their mean age was 1.62 weeks (95% confidence interval (CI) 1.35 to 1.89). Clinical neonatal hip screening revealed a sensitivity of 62% (mean, 62.6 95%CI 50.9 to 74.3), specificity of 99.8% (mean, 99.8, 95% CI 99.7 to 99.8) and positive predictive value (PPV) of 24% (mean, 26.2, 95% CI 19.3 to 33.0). Static and dynamic sonography for Graf type IV dysplastic hips had a 15-year sensitivity of 77% (mean, 75.8 95% CI 66.9 to 84.6), specificity of 99.8% (mean, 99.8, 95% CI 99.8 to 99.8) and a PPV of 49% (mean, 55.1, 95% CI 41.6 to 68.5). There were 36 infants with an irreducible dislocation of the hip (0.57 per 1000 live births), including six that failed to resolve with neonatal splintage. Most clinically unstable hips referred to a specialist clinic are female and stabilise spontaneously. Most irreducible dislocations are not identified from this neonatal instability group. There may be a small subgroup of females with instability of the hip which may be at risk of progression to irreducibility despite early treatment in a Pavlik harness. A controlled study is required to assess the value of neonatal clinical screening programmes. PMID:25628293

  11. Dermoscopic patterns in patients with a clinical diagnosis of onychomycosis—results of a prospective study including data of potassium hydroxide (KOH) and culture examination

    PubMed Central

    Jesús-Silva, Miriam América; Fernández-Martínez, Ramón; Roldán-Marín, Rodrigo; Arenas, Roberto

    2015-01-01

    Background: Onychomycosis is the most common nail disease, representing 50% of cases affecting the nail apparatus. The diagnosis is made by clinical examination along with the KOH exam of the nail and culture of the sample. However, not all dermatologists have access to a mycology lab. Objective: To determine the correlation between KOH examination and dermoscopic patterns in patients with clinical diagnosis of onychomycosis. Patients/Methods: A descriptive, open, observational, prospective, cross-sectional study of 178 patients with clinical suspicion of onychomycosis was conducted. All patients underwent clinical examination, dermoscopy with a DermLite PHOTO dermatoscope (3Gen, San Juan Capistrano, CA, USA), KOH assessment and culture analysis. The most frequent dermoscopic patterns were identified and their correlation with the clinical subtype of onychomycosis was analyzed. Results: The study included 178 patients with clinical suspicion of onychomycosis. Of these, 155 (87.1%) had positive direct KOH examination for onychomycosis. Eighty-seven patients (56.13%) presented with clinical onychomycosis pattern of total dystrophic onychomycosis (TDO), 67 (43.23%) with distal lateral subungual onychomycosis (DLSO), 1 (0.65%) with trachyonychia). Dermoscopic patterns of onychomycosis showed the following frequencies: the spiked pattern was present in 22 patients (14.19%), longitudinal striae pattern in 51 patients (32.9%) and linear edge pattern in 21 patients (13.55%). We identified a pattern described as “distal irregular termination” in 41 patients with TDO and 26 with DLSO. Conclusions: This is the fist study conducted in a Mexican population that uses dermoscopy as a diagnostic tool along with the KOH examination for the diagnosis of onychomycosis. Dermoscopy may be used as an important diagnostic tool when evaluating nail disease. However, it should not be used as the only diagnostic criteria for onychomycosis. PMID:26114050

  12. Co-occurrence analyses show that non-random community structure is disrupted by fire in two groups of soil arthropods (Isopoda Oniscidea and Collembola)

    NASA Astrophysics Data System (ADS)

    Pitzalis, Monica; Luiselli, Luca; Bologna, Marco A.

    2010-01-01

    In this paper, we tested the hypothesis that natural catastrophes may destroy non-random community structure in natural assemblages of organisms. As a study system, we selected fire as the catastrophic event, and two groups of soil arthropods (Collembola and Isopoda Oniscidea) as target organisms. By co-occurrence analyses and Monte Carlo simulations of niche overlap analysis (C-score, with fixed-equiprobable model; RA2 and RA3 algorithms) we evaluated whether the community structure of these two groups were random/non-random at three unburnt sites and at three neighbour burnt sites that were devastated by a large-scale fire in summer 2000. Both taxa experienced a remarkable reduction in the number of species sampled in burnt versus unburnt sites, but the difference among sites was not statistically significant for Oniscidea. We determined that community structure was clearly non-random at the unburnt sites for both Collembola (according to RA3 algorithm) and Isopoda Oniscidea (according to co-occurrence analysis) and that, as predicted by theory, the catastrophic event did deeply alter the community structure by removing the non-random organization of the species interactions. We also observed a shift from segregation to aggregation/randomness in soil arthropods communities affected by fire, a pattern that was similar to that observed in natural communities of organisms perturbed by the introduction of alien species, thus indicating that this pattern may be generalizable when alteration of communities may occur.

  13. Issues Relating to Study Design and Risk of Bias When Including Non-Randomized Studies in Systematic Reviews on the Effects of Interventions

    ERIC Educational Resources Information Center

    Higgins, Julian P. T.; Ramsay, Craig; Reeves, Barnaby C.; Deeks, Jonathan J.; Shea, Beverley; Valentine, Jeffrey C.; Tugwell, Peter; Wells, George

    2013-01-01

    Non-randomized studies may provide valuable evidence on the effects of interventions. They are the main source of evidence on the intended effects of some types of interventions and often provide the only evidence about the effects of interventions on long-term outcomes, rare events or adverse effects. Therefore, systematic reviews on the effects…

  14. Issues Relating to Confounding and Meta-analysis When Including Non-Randomized Studies in Systematic Reviews on the Effects of Interventions

    ERIC Educational Resources Information Center

    Valentine, Jeffrey C.; Thompson, Simon G.

    2013-01-01

    Background: Confounding caused by selection bias is often a key difference between non-randomized studies (NRS) and randomized controlled trials (RCTs) of interventions. Key methodological issues: In this third paper of the series, we consider issues relating to the inclusion of NRS in systematic reviews on the effects of interventions. We discuss…

  15. “Cancer 2015”: A Prospective, Population-Based Cancer Cohort—Phase 1: Feasibility of Genomics-Guided Precision Medicine in the Clinic

    PubMed Central

    Parisot, John P.; Thorne, Heather; Fellowes, Andrew; Doig, Ken; Lucas, Mark; McNeil, John J.; Doble, Brett; Dobrovic, Alexander; John, Thomas; James, Paul A.; Lipton, Lara; Ashley, David; Hayes, Theresa; McMurrick, Paul; Richardson, Gary; Lorgelly, Paula; Fox, Stephen B.; Thomas, David M.

    2015-01-01

    “Cancer 2015” is a longitudinal and prospective cohort. It is a phased study whose aim was to pilot recruiting 1000 patients during phase 1 to establish the feasibility of providing a population-based genomics cohort. Newly diagnosed adult patients with solid cancers, with residual tumour material for molecular genomics testing, were recruited into the cohort for the collection of a dataset containing clinical, molecular pathology, health resource use and outcomes data. 1685 patients have been recruited over almost 3 years from five hospitals. Thirty-two percent are aged between 61–70 years old, with a median age of 63 years. Diagnostic tumour samples were obtained for 90% of these patients for multiple parallel sequencing. Patients identified with somatic mutations of potentially “actionable” variants represented almost 10% of those tumours sequenced, while 42% of the cohort had no mutations identified. These genomic data were annotated with information such as cancer site, stage, morphology, treatment and patient outcomes and health resource use and cost. This cohort has delivered its main objective of establishing an upscalable genomics cohort within a clinical setting and in phase 2 aims to develop a protocol for how genomics testing can be used in real-time clinical decision-making, providing evidence on the value of precision medicine to clinical practice. PMID:26529019

  16. Prospective assessment of a gene signature potentially predictive of clinical benefit in metastatic melanoma patients following MAGE-A3 immunotherapeutic (PREDICT)

    PubMed Central

    Saiag, P.; Gutzmer, R.; Ascierto, P. A.; Maio, M.; Grob, J.-J.; Murawa, P.; Dreno, B.; Ross, M.; Weber, J.; Hauschild, A.; Rutkowski, P.; Testori, A.; Levchenko, E.; Enk, A.; Misery, L.; Vanden Abeele, C.; Vojtek, I.; Peeters, O.; Brichard, V. G.; Therasse, P.

    2016-01-01

    Background Genomic profiling of tumor tissue may aid in identifying predictive or prognostic gene signatures (GS) in some cancers. Retrospective gene expression profiling of melanoma and non-small-cell lung cancer led to the characterization of a GS associated with clinical benefit, including improved overall survival (OS), following immunization with the MAGE-A3 immunotherapeutic. The goal of the present study was to prospectively evaluate the predictive value of the previously characterized GS. Patients and methods An open-label prospective phase II trial (‘PREDICT’) in patients with MAGE-A3-positive unresectable stage IIIB-C/IV-M1a melanoma. Results Of 123 subjects who received the MAGE-A3 immunotherapeutic, 71 (58.7%) displayed the predictive GS (GS+). The 1-year OS rate was 83.1%/83.3% in the GS+/GS− populations. The rate of progression-free survival at 12 months was 5.8%/4.1% in GS+/GS− patients. The median time-to-treatment failure was 2.7/2.4 months (GS+/GS−). There was one complete response (GS−) and two partial responses (GS+). The MAGE-A3 immunotherapeutic was similarly immunogenic in both populations and had a clinically acceptable safety profile. Conclusion Treatment of patients with MAGE-A3-positive unresectable stage IIIB-C/IV-M1a melanoma with the MAGE-A3 immunotherapeutic demonstrated an overall 1-year OS rate of 83.5%. GS− and GS+ patients had similar 1-year OS rates, indicating that in this study, GS was not predictive of outcome. Unexpectedly, the objective response rate was lower in this study than in other studies carried out in the same setting with the MAGE-A3 immunotherapeutic. Investigation of a GS to predict clinical benefit to adjuvant MAGE-A3 immunotherapeutic treatment is ongoing in another melanoma study. This study is registered at www.clinicatrials.gov NCT00942162. PMID:27502712

  17. The “Laboratory” Effect: Comparing Radiologists' Performance and Variability during Prospective Clinical and Laboratory Mammography Interpretations1

    PubMed Central

    Gur, David; Bandos, Andriy I.; Cohen, Cathy S.; Hakim, Christiane M.; Hardesty, Lara A.; Ganott, Marie A.; Perrin, Ronald L.; Poller, William R.; Shah, Ratan; Sumkin, Jules H.; Wallace, Luisa P.; Rockette, Howard E.

    2008-01-01

    Purpose: To compare radiologists' performance during interpretation of screening mammograms in the clinic with their performance when reading the same mammograms in a retrospective laboratory study. Materials and Methods: This study was conducted under an institutional review board–approved, HIPAA-compliant protocol; the need for informed consent was waived. Nine experienced radiologists rated an enriched set of mammograms that they had personally read in the clinic (the “reader-specific” set) mixed with an enriched “common” set of mammograms that none of the participants had previously read in the clinic by using a screening Breast Imaging Reporting and Data System (BI-RADS) rating scale. The original clinical recommendations to recall the women for a diagnostic work-up, for both reader-specific and common sets, were compared with their recommendations during the retrospective experiment. The results are presented in terms of reader-specific and group-averaged sensitivity and specificity levels and the dispersion (spread) of reader-specific performance estimates. Results: On average, the radiologists' performance was significantly better in the clinic than in the laboratory (P = .035). Interreader dispersion of the computed performance levels was significantly lower during the clinical interpretations (P < .01). Conclusion: Retrospective laboratory experiments may not represent either expected performance levels or interreader variability during clinical interpretations of the same set of mammograms in the clinical environment well. © RSNA, 2008 PMID:18682584

  18. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Safeguards for Children in Clinical Investigations § 50.53 Clinical investigations involving greater than... in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an... involve children as subjects only if the IRB finds and documents that: (a) The risk represents a...

  19. What Proportion of Incident Radiographic Vertebral Fractures in Older Men Is Clinically Diagnosed and Vice Versa: A Prospective Study.

    PubMed

    Ensrud, Kristine E; Blackwell, Terri L; Fink, Howard A; Zhang, Jie; Cauley, Jane A; Cawthon, Peggy M; Black, Dennis M; Bauer, Douglas C; Curtis, Jeffrey R; Orwoll, Eric S; Barrett-Connor, Elizabeth; Kado, Deborah M; Marshall, Lynn M; Shikany, James M; Schousboe, John T

    2016-08-01

    To determine the proportion of incident radiographic vertebral fractures (vfx) also diagnosed as incident clinical vfx in older men and vice-versa, we used data from 4398 community-dwelling men age ≥65 years enrolled in the Osteoporotic Fractures in Men (MrOS) study. Incident radiographic vfx were identified by comparing baseline and follow-up lateral thoracic and lumbar spine study films (average 4.6 years between films) using a semiquantitative (SQ) method and defined as a change in SQ reading of ≥1 at a given vertebral level from baseline to follow-up study radiograph. Participants were contacted triannually to ascertain incident clinical vfx; community spinal imaging studies were obtained and clinical vfx were confirmed when the study radiologist determined that the community imaging study showed a new deformity of higher grade than was present in the same vertebra on the baseline study radiograph. A total of 237 incident radiographic vfx were identified in 197 men, whereas 31 men experienced 37 confirmed incident clinical vfx. Of incident radiographic vfx, 13.5% were also clinically diagnosed as incident fractures, with clinical diagnoses made for 16.3% of the radiographic vfx with SQ grade change ≥2. Of incident clinical vfx, 86.5% were identified as incident radiographic vfx, most of them with SQ grade change ≥2. In summary, less than 15% of incident radiographic vfx were also clinically diagnosed, whereas the majority of incident clinical vfx were identified as severe radiographic vfx. These results in men supplement those previously published for women and suggest a complex relationship between clinical and radiographic vfx in older adults. Published 2016.(†) American Society for Bone and Mineral Research. PMID:26969847

  20. A school intervention for mental health literacy in adolescents: effects of a non-randomized cluster controlled trial

    PubMed Central

    2013-01-01

    Background “Mental health for everyone” is a school program for mental health literacy and prevention aimed at secondary schools (13–15 yrs). The main aim was to investigate whether mental health literacy, could be improved by a 3-days universal education programme by: a) improving naming of symptom profiles of mental disorder, b) reducing prejudiced beliefs, and c) improving knowledge about where to seek help for mental health problems. A secondary aim was to investigate whether adolescent sex and age influenced the above mentioned variables. A third aim was to investigate whether prejudiced beliefs influenced knowledge about available help. Method This non-randomized cluster controlled trial included 1070 adolescents (53.9% boys, M age14 yrs) from three schools in a Norwegian town. One school (n = 520) received the intervention, and two schools (n = 550) formed the control group. Pre-test and follow-up were three months apart. Linear mixed models and generalized estimating equations models were employed for analysis. Results Mental health literacy improved contingent on the intervention, and there was a shift towards suggesting primary health care as a place to seek help. Those with more prejudiced beleifs did not suggest places to seek help for mental health problems. Generally, girls and older adolescents recognized symptom profiles better and had lower levels of prejudiced beliefs. Conclusions A low cost general school program may improve mental health literacy in adolescents. Gender specific programs and attention to the age and maturity of the students should be considered when mental health literacy programmes are designed and tried out. Prejudice should be addressed before imparting information about mental health issues. PMID:24053381

  1. A Year of Infection in the Intensive Care Unit: Prospective Whole Genome Sequencing of Bacterial Clinical Isolates Reveals Cryptic Transmissions and Novel Microbiota

    PubMed Central

    Roach, David J.; Burton, Joshua N.; Lee, Choli; Stackhouse, Bethany; Butler-Wu, Susan M.; Cookson, Brad T.

    2015-01-01

    Bacterial whole genome sequencing holds promise as a disruptive technology in clinical microbiology, but it has not yet been applied systematically or comprehensively within a clinical context. Here, over the course of one year, we performed prospective collection and whole genome sequencing of nearly all bacterial isolates obtained from a tertiary care hospital’s intensive care units (ICUs). This unbiased collection of 1,229 bacterial genomes from 391 patients enables detailed exploration of several features of clinical pathogens. A sizable fraction of isolates identified as clinically relevant corresponded to previously undescribed species: 12% of isolates assigned a species-level classification by conventional methods actually qualified as distinct, novel genomospecies on the basis of genomic similarity. Pan-genome analysis of the most frequently encountered pathogens in the collection revealed substantial variation in pan-genome size (1,420 to 20,432 genes) and the rate of gene discovery (1 to 152 genes per isolate sequenced). Surprisingly, although potential nosocomial transmission of actively surveilled pathogens was rare, 8.7% of isolates belonged to genomically related clonal lineages that were present among multiple patients, usually with overlapping hospital admissions, and were associated with clinically significant infection in 62% of patients from which they were recovered. Multi-patient clonal lineages were particularly evident in the neonatal care unit, where seven separate Staphylococcus epidermidis clonal lineages were identified, including one lineage associated with bacteremia in 5/9 neonates. Our study highlights key differences in the information made available by conventional microbiological practices versus whole genome sequencing, and motivates the further integration of microbial genome sequencing into routine clinical care. PMID:26230489

  2. A Year of Infection in the Intensive Care Unit: Prospective Whole Genome Sequencing of Bacterial Clinical Isolates Reveals Cryptic Transmissions and Novel Microbiota.

    PubMed

    Roach, David J; Burton, Joshua N; Lee, Choli; Stackhouse, Bethany; Butler-Wu, Susan M; Cookson, Brad T; Shendure, Jay; Salipante, Stephen J

    2015-07-01

    Bacterial whole genome sequencing holds promise as a disruptive technology in clinical microbiology, but it has not yet been applied systematically or comprehensively within a clinical context. Here, over the course of one year, we performed prospective collection and whole genome sequencing of nearly all bacterial isolates obtained from a tertiary care hospital's intensive care units (ICUs). This unbiased collection of 1,229 bacterial genomes from 391 patients enables detailed exploration of several features of clinical pathogens. A sizable fraction of isolates identified as clinically relevant corresponded to previously undescribed species: 12% of isolates assigned a species-level classification by conventional methods actually qualified as distinct, novel genomospecies on the basis of genomic similarity. Pan-genome analysis of the most frequently encountered pathogens in the collection revealed substantial variation in pan-genome size (1,420 to 20,432 genes) and the rate of gene discovery (1 to 152 genes per isolate sequenced). Surprisingly, although potential nosocomial transmission of actively surveilled pathogens was rare, 8.7% of isolates belonged to genomically related clonal lineages that were present among multiple patients, usually with overlapping hospital admissions, and were associated with clinically significant infection in 62% of patients from which they were recovered. Multi-patient clonal lineages were particularly evident in the neonatal care unit, where seven separate Staphylococcus epidermidis clonal lineages were identified, including one lineage associated with bacteremia in 5/9 neonates. Our study highlights key differences in the information made available by conventional microbiological practices versus whole genome sequencing, and motivates the further integration of microbial genome sequencing into routine clinical care. PMID:26230489

  3. How Many Samples and How Many Culture Media To Diagnose a Prosthetic Joint Infection: a Clinical and Microbiological Prospective Multicenter Study

    PubMed Central

    Léger, Julie; Tandé, Didier; Plouzeau, Chloé; Valentin, Anne Sophie; Jolivet-Gougeon, Anne; Lemarié, Carole; Kempf, Marie; Héry-Arnaud, Geneviève; Bret, Laurent; Juvin, Marie Emmanuelle; Giraudeau, Bruno; Burucoa, Christophe

    2015-01-01

    Although numerous perioperative samples and culture media are required to diagnose prosthetic joint infection (PJI), their exact number and types have not yet been definitely determined with a high level of proof. We conducted a prospective multicenter study to determine the minimal number of samples and culture media required for accurate diagnosis of PJI. Over a 2-year period, consecutive patients with clinical signs suggesting PJI were included, with five perioperative samples per patient. The bacteriological and PJI diagnosis criteria were assessed using a random selection of two, three, or four samples and compared with those obtained using the recommended five samples (references guidelines). The results obtained with two or three culture media were then compared with those obtained with five culture media for both criteria. The times-to-positivity of the different culture media were calculated. PJI was confirmed in 215/264 suspected cases, with a bacteriological criterion in 192 (89%). The PJI was monomicrobial (85%) or polymicrobial (15%). Percentages of agreement of 98.1% and 99.7%, respectively, for the bacteriological criterion and confirmed PJI diagnosis were obtained when four perioperative samples were considered. The highest percentages of agreement were obtained with the association of three culture media, a blood culture bottle, a chocolate agar plate, and Schaedler broth, incubated for 5, 7, and 14 days, respectively. This new procedure leads to significant cost saving. Our prospective multicenter study showed that four samples seeded on three culture media are sufficient for diagnosing PJI. PMID:26637380

  4. How Many Samples and How Many Culture Media To Diagnose a Prosthetic Joint Infection: a Clinical and Microbiological Prospective Multicenter Study.

    PubMed

    Bémer, Pascale; Léger, Julie; Tandé, Didier; Plouzeau, Chloé; Valentin, Anne Sophie; Jolivet-Gougeon, Anne; Lemarié, Carole; Kempf, Marie; Héry-Arnaud, Geneviève; Bret, Laurent; Juvin, Marie Emmanuelle; Giraudeau, Bruno; Corvec, Stéphane; Burucoa, Christophe

    2016-02-01

    Although numerous perioperative samples and culture media are required to diagnose prosthetic joint infection (PJI), their exact number and types have not yet been definitely determined with a high level of proof. We conducted a prospective multicenter study to determine the minimal number of samples and culture media required for accurate diagnosis of PJI. Over a 2-year period, consecutive patients with clinical signs suggesting PJI were included, with five perioperative samples per patient. The bacteriological and PJI diagnosis criteria were assessed using a random selection of two, three, or four samples and compared with those obtained using the recommended five samples (references guidelines). The results obtained with two or three culture media were then compared with those obtained with five culture media for both criteria. The times-to-positivity of the different culture media were calculated. PJI was confirmed in 215/264 suspected cases, with a bacteriological criterion in 192 (89%). The PJI was monomicrobial (85%) or polymicrobial (15%). Percentages of agreement of 98.1% and 99.7%, respectively, for the bacteriological criterion and confirmed PJI diagnosis were obtained when four perioperative samples were considered. The highest percentages of agreement were obtained with the association of three culture media, a blood culture bottle, a chocolate agar plate, and Schaedler broth, incubated for 5, 7, and 14 days, respectively. This new procedure leads to significant cost saving. Our prospective multicenter study showed that four samples seeded on three culture media are sufficient for diagnosing PJI.

  5. How Many Samples and How Many Culture Media To Diagnose a Prosthetic Joint Infection: a Clinical and Microbiological Prospective Multicenter Study.

    PubMed

    Bémer, Pascale; Léger, Julie; Tandé, Didier; Plouzeau, Chloé; Valentin, Anne Sophie; Jolivet-Gougeon, Anne; Lemarié, Carole; Kempf, Marie; Héry-Arnaud, Geneviève; Bret, Laurent; Juvin, Marie Emmanuelle; Giraudeau, Bruno; Corvec, Stéphane; Burucoa, Christophe

    2016-02-01

    Although numerous perioperative samples and culture media are required to diagnose prosthetic joint infection (PJI), their exact number and types have not yet been definitely determined with a high level of proof. We conducted a prospective multicenter study to determine the minimal number of samples and culture media required for accurate diagnosis of PJI. Over a 2-year period, consecutive patients with clinical signs suggesting PJI were included, with five perioperative samples per patient. The bacteriological and PJI diagnosis criteria were assessed using a random selection of two, three, or four samples and compared with those obtained using the recommended five samples (references guidelines). The results obtained with two or three culture media were then compared with those obtained with five culture media for both criteria. The times-to-positivity of the different culture media were calculated. PJI was confirmed in 215/264 suspected cases, with a bacteriological criterion in 192 (89%). The PJI was monomicrobial (85%) or polymicrobial (15%). Percentages of agreement of 98.1% and 99.7%, respectively, for the bacteriological criterion and confirmed PJI diagnosis were obtained when four perioperative samples were considered. The highest percentages of agreement were obtained with the association of three culture media, a blood culture bottle, a chocolate agar plate, and Schaedler broth, incubated for 5, 7, and 14 days, respectively. This new procedure leads to significant cost saving. Our prospective multicenter study showed that four samples seeded on three culture media are sufficient for diagnosing PJI. PMID:26637380

  6. Prospective Evaluation of Visual Acuity Assessment: A Comparison of Snellen Versus ETDRS Charts in Clinical Practice (An AOS Thesis)

    PubMed Central

    Kaiser, Peter K.

    2009-01-01

    Purpose: The purpose of this study was twofold: first, to prospectively compare visual acuity (VA) scores obtained with Snellen charts versus Early Treatment Diabetic Retinopathy Study (ETDRS) charts in a “real world” retinal practice, and second, to see if there was a difference in visual acuity measurements obtained with ETDRS charts starting at 4 or 2 meters. Methods: Prospective, consecutive evaluation of patients who underwent best-corrected visual acuity testing of their right eye performed at a single seating by the same experienced, certified vision examiner in the same room with standardized low light conditions using a projected Snellen chart at 20 feet, and two different back-illuminated ETDRS charts placed 4 and 2 meters from the patient. Results: One hundred sixty-three eyes were included in the study. The mean Snellen VA was 0.67 logMAR (20/94), ETDRS VA at 4 meters was 0.54 logMAR (~20/69), and ETDRS VA at 2 meters was 0.51 logMAR (~20/65). The mean difference was 6.5 letters better on the ETDRS chart (P=.000000001). As the VA worsened, there was increased variability between the charts and the mean discrepancy between charts also increased. Subgroup analysis revealed the greatest difference between charts was in the poor vision subgroup (<20/200) with a difference of 0.2 logMAR (10 letters; P=.0000002). Patients with exudative age-related macular degeneration (AMD) had the greatest disparity on vision testing, but patients with dry AMD and diabetic retinopathy also exhibited significant differences. Conclusions: Visual acuity scores were significantly better on ETDRS charts compared to Snellen charts. The difference was greatest with poor visual acuity (<20/200) and in patients with exudative AMD. Thus, caution should be exercised when comparing data using the different charts. PMID:20126505

  7. Osseous Pseudoprogression in Vertebral Bodies Treated with Stereotactic Radiosurgery: A Secondary Analysis of Prospective Phase I/II Clinical Trials

    PubMed Central

    Amini, Behrang; Beaman, Charles B.; Madewell, John E.; Allen, Pamela K.; Rhines, Laurence D.; Tatsui, Claudio E.; Tannir, Nizar M.; Li, Jing; Brown, Paul D.; Ghia, Amol J.

    2015-01-01

    Background and Purpose Osseous pseudoprogression (OPP) on MRI can mimic true progression in lesions treated with spine stereotactic radiosurgery (SSRS). Our aim is to describe the prevalence and time course of OPP, in order to assist radiologists in assessment of post-SSRS patients. Materials and Methods A secondary analysis of two prospective trials was performed. MRIs before and after SSRS were assessed for response. OPP was defined as transient growth in signal abnormality centered at the lesion with a sustained decline on follow-up MRI that was not attributable to chemotherapy. Results From the initial set of 223 patients, 37 lesions in 36 patients met inclusion criteria and were selected for secondary analysis. Five of the 37 lesions (14%) demonstrated OPP and 9 demonstrated progressive disease. There was significant association between single-fraction therapy and the development of OPP (p=0.01), and there was a significant difference in OPP-free survival between single- and multi-fraction regimens (p=0.0052). In lesions demonstrating OPP, time to peak size occurred between 9.7 and 24.4 weeks after SSRS (mean: 13.9 weeks, 95% CI: 8.6–19.1 weeks). The peak lesion size was between 4–10 mm larger than baseline. Most lesions returned to baseline size between 23–52.4 weeks following SSRS. Conclusions Progression on MRI obtained between 3 and 6 months following SSRS should be treated with caution, as OPP may be seen in > 1/3 of these lesions. Single-fraction SSRS may be associated with OPP. The possibility of OPP should be incorporated into prospective criteria for assessment of local control following SSRS. PMID:26494690

  8. Prospective Evaluation of a Model-Based Dosing Regimen for Amikacin in Preterm and Term Neonates in Clinical Practice

    PubMed Central

    De Cock, R. F. W.; Allegaert, K.; Vanhaesebrouck, S.; Danhof, M.; Knibbe, C. A. J.

    2015-01-01

    Based on a previously derived population pharmacokinetic model, a novel neonatal amikacin dosing regimen was developed. The aim of the current study was to prospectively evaluate this dosing regimen. First, early (before and after second dose) therapeutic drug monitoring (TDM) observations were evaluated for achieving target trough (<3 mg/liter) and peak (>24 mg/liter) levels. Second, all observed TDM concentrations were compared with model-predicted concentrations, whereby the results of a normalized prediction distribution error (NPDE) were considered. Subsequently, Monte Carlo simulations were performed. Finally, remaining causes limiting amikacin predictability (i.e., prescription errors and disease characteristics of outliers) were explored. In 579 neonates (median birth body weight, 2,285 [range, 420 to 4,850] g; postnatal age 2 days [range, 1 to 30 days]; gestational age, 34 weeks [range, 24 to 41 weeks]), 90.5% of the observed early peak levels reached 24 mg/liter, and 60.2% of the trough levels were <3 mg/liter (93.4% ≤5 mg/liter). Observations were accurately predicted by the model without bias, which was confirmed by the NPDE. Monte Carlo simulations showed that peak concentrations of >24 mg/liter were reached at steady state in almost all patients. Trough values of <3 mg/liter at steady state were documented in 78% to 100% and 45% to 96% of simulated cases with and without ibuprofen coadministration, respectively; suboptimal trough levels were found in patients with postnatal age <14 days and current weight of >2,000 g. Prospective evaluation of a model-based neonatal amikacin dosing regimen resulted in optimized peak and trough concentrations in almost all patients. Slightly adapted dosing for patient subgroups with suboptimal trough levels was proposed. This model-based approach improves neonatal dosing individualization. PMID:26248375

  9. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study

    PubMed Central

    2013-01-01

    Background Improvements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements in health-related quality of life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from the patient’s perspective in routine clinical practice are lacking. We examined PROs in patients initiating injectable treatment in the CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) study. Methods CHOICE was a 24-month, prospective observational study conducted in six European countries. Patients initiated exenatide twice daily (BID) or insulin based on a physician’s clinical judgement. Clinical and PRO data were collected at baseline (injectable therapy initiation) and after approximately 3, 6, 12, 18 and 24 months. The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted. Results There were 2388 patients eligible for analysis (exenatide BID cohort, n = 1114; insulin cohort, n = 1274). Mean positive changes in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score and EuroQoL5-Dimension (EQ-5D) index and visual analogue scale (VAS) scores were observed in both cohorts with most changes observed during the first 6 months after injectable therapy initiation. Patients who experienced weight loss (≥1 kg) at 24 months appeared to have higher mean improvements in IWQOL-Lite total score than did patients with weight gain or no weight change. Patients who met the composite clinical endpoint of glycated haemoglobin (HbA1c) <7.0%, no weight gain (≤1 kg) and no hypoglycaemia generally experienced higher mean improvements in EQ-5D index and VAS scores (compared with patients who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts). High levels of missing data were observed for all PRO measures in both

  10. Clinical outcome and predictors of mortality in children with sepsis, severe sepsis, and septic shock from Rohtak, Haryana: A prospective observational study

    PubMed Central

    Kaur, Gurpreet; Vinayak, Nikhil; Mittal, Kundan; Kaushik, Jaya Shankar; Aamir, Mohammad

    2014-01-01

    Background: Information regarding early predictive factors for mortality and morbidity in sepsis is limited from developing countries. Methods: A prospective observational study was conducted to determine the clinical outcome and predictors of mortality in children with sepsis, severe sepsis, and septic shock. Children aged 1 month to 14 years admitted to a tertiary care pediatric intensive care unit (PICU) with a diagnosis of sepsis, severe sepsis, or septic shock were enrolled in the study. Hemodynamic and laboratory parameters which discriminate survivors from nonsurvivors were evaluated. Results: A total of 50 patients (30 [60%] males) were enrolled in the study, of whom 21 (42%) were discharged (survivors) and rest 29 (58%) expired (nonsurvivor). Median (interquartile range) age of enrolled patients were 18 (6, 60) months. Mortality was not significantly predicted individually by any factor including age (odds ratio [OR] [95% confidence interval [CI

  11. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

    PubMed Central

    Kotela, Andrzej; Lorkowski, Jacek; Kucharzewski, Marek; Wilk-Frańczuk, Magdalena; Śliwiński, Zbigniew; Frańczuk, Bogusław; Łęgosz, Paweł  ; Kotela, Ireneusz

    2015-01-01

    Total knee arthroplasty (TKA) is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA. PMID:26301241

  12. The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial.

    PubMed

    Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

    2012-01-01

    Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

  13. The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial.

    PubMed

    Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

    2012-01-01

    Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone. PMID:22778774

  14. The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

    PubMed Central

    Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

    2012-01-01

    Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7 (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone. PMID:22778774

  15. Comparison between three-dimensional and standard miniplates in the management of mandibular angle fractures: a prospective, randomized, double-blind, controlled clinical study.

    PubMed

    Al-Moraissi, E A; Mounair, R M; El-Sharkawy, T M; El-Ghareeb, T I

    2015-03-01

    The aim of this study was to compare the clinical and radiological outcomes of mandibular angle fractures (MAFs) managed with three-dimensional (3D) miniplates and standard miniplates (according to Champy's principles). A prospective, randomized, controlled clinical study was carried out on 20 patients with MAFs, divided into two groups. Group A patients were treated with a single 1-mm 3D titanium miniplate; group B patients were treated with a single 2.0-mm standard titanium miniplate. Patients were followed for 6 months for infection, wound dehiscence, segmental mobility, malocclusion, mouth opening, hardware failure, hardware palpability, paraesthesia, and malunion/non-union. A densitometry analysis was performed using DIGORA software on digital panoramic radiographs to evaluate bone healing. Six complications occurred, representing a total rate of 30%. Three complications occurred in group A and three in group B, with identical complication rates of 30%. No major difference in terms of the radiographic assessment was observed between the two systems. The 3D curved strut plate is an effective treatment modality for the management of MAFs, with a complication rate comparable to that found with the standard miniplate. This trial is registered at ClinicalTrials.gov, number NCT01939015.

  16. Prospective Study in a Porcine Model of Sarcoptes scabiei Indicates the Association of Th2 and Th17 Pathways with the Clinical Severity of Scabies

    PubMed Central

    Mounsey, Kate E.; Murray, Hugh C.; Bielefeldt-Ohmann, Helle; Pasay, Cielo; Holt, Deborah C.; Currie, Bart J.; Walton, Shelley F.; McCarthy, James S.

    2015-01-01

    Background Understanding of scabies immunopathology has been hampered by the inability to undertake longitudinal studies in humans. Pigs are a useful animal model for scabies, and show clinical and immunologic changes similar to those in humans. Crusted scabies can be readily established in pigs by treatment with the glucocorticoid dexamethasone (Dex). Methodology/ Principal Findings Prospective study of 24 pigs in four groups: a) Scabies+/Dex+, b) Scabies+/Dex-, c) Scabies-/Dex+ and d) Scabies-/Dex-. Clinical symptoms were monitored. Histological profiling and transcriptional analysis of skin biopsies was undertaken to compare changes in cell infiltrates and representative cytokines. A range of clinical responses to Sarcoptes scabiei were observed in Dex treated and non-immunosuppressed pigs. An association was confirmed between disease severity and transcription of the Th2 cytokines IL-4 and IL-13, and up-regulation of the Th17 cytokines IL-17 and IL-23 in pigs with crusted scabies. Immunohistochemistry revealed marked infiltration of lymphocytes and mast cells, and strong staining for IL-17. Conclusions/ Significance While an allergic Th2 type response to scabies has been previously described, these results suggest that IL-17 related pathways may also contribute to immunopathology of crusted scabies. This may lead to new strategies to protect vulnerable subjects from contracting recurrent crusted scabies. PMID:25730203

  17. Correlating perceived arrhythmia symptoms and QoL in the elderly with Heart Failure in an urban clinic: A prospective, single center study

    PubMed Central

    Hickey, Kathleen T.; Reiffel, James; Sciacca, Robert R.; Whang, William; Biviano, Angelo; Baumeister, Maurita; Castillo, Carmen; Talathothi, Jyothi; Garan, Hasan

    2013-01-01

    Aim To determine the relationship between quality of life (QoL) and perceived self reported symptoms in an elderly, ambulatory, urban population living with heart failure (HF). Background While arrhythmias in the elderly with HF are well documented, the association between perceived arrhythmia symptoms and QoL is not well defined. Design Prospective, cross sectional single center study. Methods A single-center, prospective study was conducted with HF patients recruited from an urban outpatient cardiology clinic in the United States. Fifty-seven patients completed a baseline QoL survey with 42 of these completing the 6-month follow-up survey. QoL was evaluated with the SF-36v2™ and frequency of symptoms with the Atrial Fibrillation Severity Scale. Subjects wore an auto triggered cardiac loop monitor (LifeStar AF Express®) for 2-weeks to document arrhythmias. Data analysis utilized Spearman’s rank correlation and logistic regression. Results Baseline and 6-month QoL measures did not correlate with recorded arrhythmias. However, perceptions of diminished general health correlated significantly with symptoms of exercise intolerance, lightheadedness/dizziness, palpitations, and chest pain/pressure. By multivariable logistic regression, more severe perceived arrhythmic, symptoms of exercise intolerance, and lightheadedness/dizziness were independently associated with diminished QoL. Conclusion QoL was significantly worse in patients with perceptions of severe arrhythmic episodes and in those whose symptoms of dizziness and exercise intolerance. Relevance to clinical practice The findings of this study indicate that symptomatic HF patients suffer from poor QoL and that interventions are needed to improve QoL and decrease symptom severity. Nurses who care for HF patients play an essential role in symptom evaluation and management and could significantly improve overall QoL in these patients by carefully evaluating symptomatology and testing interventions and

  18. Six-month healing success rates after endodontic treatment using the novel GentleWave™ System: The pure prospective multi-center clinical study

    PubMed Central

    Le, Khang T.; Woo, Stacey M.; Rassoulian, Shahriar A.; McLachlan, Kimberly; Abbassi, Farah; Garland, Randy W.

    2016-01-01

    Background This prospective multi-center (PURE) clinical study evaluated healing rates for molars after root canal treatment employing the GentleWave® System (Sonendo, Inc., Laguna Hills, CA). Material and Methods Eighty-nine patients met the inclusion criteria and consented for this clinical study after referral for a root canal treatment. All enrolled patients were treated with the GentleWave System. Five endodontists performed the clinical procedures and follow-up evaluations. Pre-operative, intra-operative, and post-operative data were collected from the consented patients. Each patient was evaluated for clinical signs and symptoms. Two trained, blinded, and independent evaluators scored the subject tooth radiographs for apical periodontitis using the periapical index (PAI). The teeth classified as healing or healed were considered as a success and composed of a cumulative success rate of healing. Statistical analysis was performed by using the Fisher’s exact test, Pearson correlation, and multivariate logistic regression analyses of the pre-operative prognostic factors at 0.05 significance level. Results Seventy-seven patients were evaluated at six months with a follow-up rate of 86.5%. The cumulative success rate of healing was 97.4%. Eleven prognostic factors were identified using bivariate analyses. Using logistic analyses, the two prognostic significant variables that were directly correlated to healing were the pre-operative presence of periapical index (p value=0.016), and single treatment visits (p value=0.024). Conclusions In this six-month PURE clinical study, the cumulative success rate of healing was 97.4% when patients were treated with the GentleWave® System. Key words:Healing rate, root canal treatment, molar, GentleWave™, Sonendo®, Multisonic Ultracleaning™ . PMID:27398180

  19. Prospective evaluation of the value of direct referral hearing aid clinic in management of young patients with bilateral hearing loss.

    PubMed

    Abdelkader, M; McEwan, M; Cooke, L

    2004-06-01

    The purpose of this study was to evaluate the value and effectiveness of a direct referral hearing aid clinic (DRHAC) in providing appropriate hearing aids to young patients aged 18-60 years while at the same time identifying patients with significant ear disease who need an otologist's opinion. The patients were referred to a tertiary referral hearing assessment clinic. A total of 137 patients (18-60 years) met the criteria to be included in the study to be assessed in the clinic by both an audiometrician and an otologist. The main outcome measures were hearing evaluation and audiometrician's management. Of them, 114 patients attended the research clinic (83%), 23 patients (17%) did not attend the clinic and 57 patients (51%) did not need any treatment or further investigation as their hearing was normal or near normal. Thirty patients (27%) were given hearing aids. Twenty-five patients (22%) failed the audiometrician assessment and were referred to the otologist. Only 13 (18%) of the 25 patients referred for an otological opinion actually required further investigations, medical or surgical treatment. DRHAC is as viable a system in the younger as in the elderly population.

  20. Effectiveness of a 'Global Postural Reeducation' program for persistent Low Back Pain: a non-randomized controlled trial

    PubMed Central

    2010-01-01

    Background The aim of this non-randomized controlled trial was to evaluate the effectiveness of a Global Postural Reeducation (GPR) program as compared to a Stabilization Exercise (SE) program in subjects with persistent low back pain (LBP) at short- and mid-term follow-up (ie. 3 and 6 months). Methods According to inclusion and exclusion criteria, 100 patients with a primary complaint of persistent LBP were enrolled in the study: 50 were allocated to the GPR group and 50 to the SE group. Primary outcome measures were Roland and Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index (ODI). Secondary outcome measures were lumbar Visual Analogue Scale (VAS) and Fingertip-to-floor test (FFT). Data were collected at baseline and at 3/6 months by health care professionals unaware of the study. An intention to treat approach was used to analyze participants according to the group to which they were originally assigned. Results Of the 100 patients initially included in the study, 78 patients completed the study: 42 in the GPR group and 36 in the SE group. At baseline, the two groups did not differ significantly with respect to gender, age, BMI and outcome measures. Comparing the differences between groups at short- and mid-term follow-up, the GPR group revealed a significant reduction (from baseline) in all outcome measures with respect to the SE group. The ordered logistic regression model showed an increased likelihood of definitive improvement (reduction from baseline of at least 30% in RMDQ and VAS scores) for the GPR group compared to the SE group (OR 3.9, 95% CI 2.7 to 5.7). Conclusions Our findings suggest that a GPR intervention in subjects with persistent LBP induces a greater improvement on pain and disability as compared to a SE program. These results must be confirmed by further studies with higher methodological standards, including randomization, larger sample size, longer follow-up and subgrouping of the LBP subjects. Trial registration NCT

  1. Diagnostic accuracy of a point-of-care urine test for tuberculosis screening among newly-diagnosed hiv-infected adults: a prospective, clinic-based study

    PubMed Central

    2014-01-01

    Background A rapid diagnostic test for active tuberculosis (TB) at the clinical point-of-care could expedite case detection and accelerate TB treatment initiation. We assessed the diagnostic accuracy of a rapid urine lipoarabinomannan (LAM) test for TB screening among HIV-infected adults in a TB-endemic setting. Methods We prospectively enrolled newly-diagnosed HIV-infected adults (≥18 years) at 4 outpatient clinics in Durban from Oct 2011-May 2012, excluding those on TB therapy. A physician evaluated all participants and offered CD4 cell count testing. Trained study nurses collected a sputum sample for acid-fast bacilli smear microscopy (AFB) and mycobacterial culture, and performed urine LAM testing using Determine™ TB LAM in the clinic. The presence of a band regardless of intensity on the urine LAM test was considered positive. We defined as the gold standard for active pulmonary TB a positive sputum culture for Mycobacterium tuberculosis. Diagnostic accuracy of urine LAM was assessed, alone and in combination with smear microscopy, and stratified by CD4 cell count. Results Among 342 newly-diagnosed HIV-infected participants, 190 (56%) were male, mean age was 35.6 years, and median CD4 was 182/mm3. Sixty participants had culture-positive pulmonary TB, resulting in an estimated prevalence of 17.5% (95% CI 13.7-22.0%). Forty-five (13.2%) participants were urine LAM positive. Mean time from urine specimen collection to LAM test result was 40 minutes (95% CI 34–46 minutes). Urine LAM test sensitivity was 28.3% (95% CI 17.5-41.4) overall, and 37.5% (95% CI 21.1-56.3) for those with CD4 count <100/mm3, while specificity was 90.1% (95% CI 86.0-93.3) overall, and 86.9% (95% CI 75.8-94.2) for those with CD4 < 100/mm3. When combined with sputum AFB (either test positive), sensitivity increased to 38.3% (95% CI 26.0-51.8), but specificity decreased to 85.8% (95% CI 81.1-89.7). Conclusions In this prospective, clinic-based study with trained nurses, a rapid

  2. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... knowledge about the subjects' disorder or condition. 50.53 Section 50.53 Food and Drugs FOOD AND DRUG... knowledge about the subjects' disorder or condition. Any clinical investigation within the scope described... knowledge about the subjects' disorder or condition that is of vital importance for the understanding...

  3. High-resolution whole-brain DCE-MRI using constrained reconstruction: Prospective clinical evaluation in brain tumor patients

    PubMed Central

    Guo, Yi; Lebel, R. Marc; Zhu, Yinghua; Lingala, Sajan Goud; Shiroishi, Mark S.; Law, Meng; Nayak, Krishna

    2016-01-01

    Purpose: To clinically evaluate a highly accelerated T1-weighted dynamic contrast-enhanced (DCE) MRI technique that provides high spatial resolution and whole-brain coverage via undersampling and constrained reconstruction with multiple sparsity constraints. Methods: Conventional (rate-2 SENSE) and experimental DCE-MRI (rate-30) scans were performed 20 minutes apart in 15 brain tumor patients. The conventional clinical DCE-MRI had voxel dimensions 0.9 × 1.3 × 7.0 mm3, FOV 22 × 22 × 4.2 cm3, and the experimental DCE-MRI had voxel dimensions 0.9 × 0.9 × 1.9 mm3, and broader coverage 22 × 22 × 19 cm3. Temporal resolution was 5 s for both protocols. Time-resolved images and blood–brain barrier permeability maps were qualitatively evaluated by two radiologists. Results: The experimental DCE-MRI scans showed no loss of qualitative information in any of the cases, while achieving substantially higher spatial resolution and whole-brain spatial coverage. Average qualitative scores (from 0 to 3) were 2.1 for the experimental scans and 1.1 for the conventional clinical scans. Conclusions: The proposed DCE-MRI approach provides clinically superior image quality with higher spatial resolution and coverage than currently available approaches. These advantages may allow comprehensive permeability mapping in the brain, which is especially valuable in the setting of large lesions or multiple lesions spread throughout the brain. PMID:27147313

  4. Misuse of antibiotics reserved for hospital settings in outpatients: a prospective clinical audit in a university hospital in Southern France.

    PubMed

    Roche, Manon; Bornet, Charléric; Monges, Philippe; Stein, Andreas; Gensollen, Sophie; Seng, Piseth

    2016-07-01

    Some antibiotics are reserved essentially for hospital settings owing to cost effectiveness and in order to fight the emerging antibiotic resistance crisis. In some cases, antibiotics reserved exclusively for use in hospitals may be prescribed in outpatients for serious infections or in the absence of a therapeutic alternative. A 30-day prospective audit of outpatient prescriptions of antibiotics reserved exclusively for use in hospitals was performed. The objective of this study was to evaluate the relevance of outpatient antibiotic prescriptions by measuring appropriateness according to guidelines. During the study period, 53 prescriptions were included, only 40% of which were appropriate. Among the 32 inappropriate prescriptions, 4 cases lacked microbial arguments, 1 case was not adequate for the infection type, 1 case involved an incorrect antibiotic dosage, 1 case involved an incorrect interval of dose administration, 3 cases had a therapeutic alternative and 22 cases were not recommended. Of the 53 prescriptions, 66% were started in hospital and 34% in outpatients. Only 25% of cases were prescribed with infectious diseases specialist (IDS) advice, 64% were based on microbiological documentation and 13% had a negative bacterial culture. Inappropriate prescriptions were usually observed in antibiotic lock therapy, skin infections, Clostridium difficile colitis, intra-abdominal infections and intravascular catheter-related infections. Outpatient prescriptions of antimicrobial drugs reserved exclusively for use in hospitals are frequently inappropriate. We recommend a real-time analysis algorithm with the involvement of an IDS for monitoring prescriptions to improve the quality of these prescriptions and possibly to prevent antibiotic resistance. PMID:27234677

  5. Clinical Evaluation of Kshara sutra Therapy in the management of Bhagandara( Fistula- in-Ano)- A prospective study

    PubMed Central

    Panigrahi, Hemanta Kumar; Rani, Rakesh; Padhi, M.M.; Lavekar, G.S.

    2009-01-01

    Study design: A prospective study of 50 patients suffering from Bhagandara(Fistula in Ano) (age ranging from 18-54years) treated by Kshara sutra therapy Place: Kshara sutra unit, Central research Unit, Punjabi bagh, New Delhi Duration: January 2007 to July 2008. Objectives: To determine the incidence of low or high anal fistula, recurrence rate following Kshara sutra therapy and effect of Ksharasutra therapy on the Bhagandara. Material and methods: The fifty patients (50) were selected randomly in the Out Patient Department. Study Design: Uncontrolled open level Study. Results: Patients were followed to see the incidence of recurrence, effect of Kshara Sutra Therapy on incontinence. Overall recurrence rate was only 5.88 %. Minor incontinence was observed only following Kshara sutra Therapy for high variety for which no treatment was given. No such complication occurred in low variety. Conclusion: Bhagandara (Fistula in Ano) can be treated by Kshara Sutra Therapy with minimal loss of sphincter muscle and low reoccurrence rate. PMID:22557318

  6. Prospective Study of the Prevalence, Genotyping, and Clinical Relevance of Dientamoeba fragilis Infections in an Australian Population

    PubMed Central

    Stark, D.; Beebe, N.; Marriott, D.; Ellis, J.; Harkness, J.

    2005-01-01

    A prospective study was conducted over a 30-month period, in which fecal specimens from 6,750 patients were submitted to the Department of Microbiology at St. Vincent's Hospital, Sydney, Australia. Trophozoites of Dientamoeba fragilis were detected in 60 (0.9%) patients by permanent staining, and confirmation was performed by PCR. Gastrointestinal symptoms were present in all patients, with diarrhea and abdominal pain the most common symptoms. Thirty-two percent of patients presented with chronic symptoms. The average age of infected patients was 39.8 years. No correlation was found between D. fragilis and Enterobius vermicularis, a proposed vector of transmission for D. fragilis. The genetic diversity of 50 D. fragilis isolates was examined by PCR, and the PCR products were analyzed for the presence of restriction fragment length polymorphisms. These results showed no variation in the small-subunit rRNA gene and demonstrated a single genotype for all Australian isolates. This study shows the potential pathogenic properties of D. fragilis and the need for all laboratories to routinely test for this organism. PMID:15956388

  7. A prospective picture collection study for a grading atlas of radiation dermatitis for clinical trials in head-and-neck cancer patients

    PubMed Central

    Zenda, Sadamoto; Ota, Yosuke; Tachibana, Hiroyuki; Ogawa, Hirofumi; Ishii, Shinobu; Hashiguchi, Chikako; Akimoto, Tetsuo; Ohe, Yuichiro; Uchitomi, Yosuke

    2016-01-01

    Radiation dermatitis is one of the most common acute toxicities of both radiotherapy and chemoradiotherapy. Many clinical trials have evaluated the level of toxicity using the Common Terminology Criteria for Adverse Events ver. 4.03. This criterion accounts for severity in a single sentence only, and no visual classification guide has been available. Thus, there is a risk of subjective interpretation by the individual investigator. This contrasts with the situation with hematologic toxicities, which can be interpreted objectively. The aim of this prospective picture collection study was to develop a grading tool for use in establishing the severity of radiation dermatitis in clinical trials. A total of 118 patients who were scheduled to receive definitive or postoperative radiotherapy or chemoradiotherapy were enrolled from the four participating cancer centers. All researchers in our group used the same model of camera under the same shooting conditions to maintain consistent photographic quality. In all, 1600 photographs were collected. Of these, 100 photographs qualified for the first round of selection and were then graded by six experts, basically in accordance with the CTCAE ver. 4.03 (JCOG ver. in Japanese). After further study, 38 photographs were selected as representing typical models for Grade 1–4 radiation dermatitis; the radiation dermatitis grading atlas was produced from these photographs. The atlas will play a major role in ensuring that the dermatitis rating system is consistent between the institutions participating in trials. We hope that this will contribute to improving the quality of clinical trials, and also to improving the level of routine clinical practice. PMID:26850926

  8. A prospective picture collection study for a grading atlas of radiation dermatitis for clinical trials in head-and-neck cancer patients.

    PubMed

    Zenda, Sadamoto; Ota, Yosuke; Tachibana, Hiroyuki; Ogawa, Hirofumi; Ishii, Shinobu; Hashiguchi, Chikako; Akimoto, Tetsuo; Ohe, Yuichiro; Uchitomi, Yosuke

    2016-06-01

    Radiation dermatitis is one of the most common acute toxicities of both radiotherapy and chemoradiotherapy. Many clinical trials have evaluated the level of toxicity using the Common Terminology Criteria for Adverse Events ver. 4.03. This criterion accounts for severity in a single sentence only, and no visual classification guide has been available. Thus, there is a risk of subjective interpretation by the individual investigator. This contrasts with the situation with hematologic toxicities, which can be interpreted objectively. The aim of this prospective picture collection study was to develop a grading tool for use in establishing the severity of radiation dermatitis in clinical trials. A total of 118 patients who were scheduled to receive definitive or postoperative radiotherapy or chemoradiotherapy were enrolled from the four participating cancer centers. All researchers in our group used the same model of camera under the same shooting conditions to maintain consistent photographic quality. In all, 1600 photographs were collected. Of these, 100 photographs qualified for the first round of selection and were then graded by six experts, basically in accordance with the CTCAE ver. 4.03 (JCOG ver. in Japanese). After further study, 38 photographs were selected as representing typical models for Grade 1-4 radiation dermatitis; the radiation dermatitis grading atlas was produced from these photographs. The atlas will play a major role in ensuring that the dermatitis rating system is consistent between the institutions participating in trials. We hope that this will contribute to improving the quality of clinical trials, and also to improving the level of routine clinical practice. PMID:26850926

  9. A new staging system for nasopharyngeal carcinoma based on intensity-modulated radiation therapy: results of a prospective multicentric clinical study

    PubMed Central

    Kang, Min; Long, Jianxiong; Li, Guisheng; Yan, Haolin; Feng, Guosheng; Liu, Meilian; Zhu, Jinxian; Wang, Rensheng

    2016-01-01

    Purpose To establish a new clinical staging standard for nasopharyngeal carcinoma (NPC), based on intensity-modulated radiotherapy (IMRT), through a prospective multicenter clinical trial. Experiment Design 492 NPC patients were selected from six hospitals in the Guangxi Zhuang Autonomous Region, China from January 2006 to December 2009. Kaplan-Meier method was adopted to calculate survival rates. Log-rank test was used to compare survival differences. Results According to the seventh edition of the UICC/AJCC staging system, the differences between T1, T2 and T3 are not statistically significant, suggesting that T1, T2 and T3 could be combined as new T1. There were significant differences between all N stages except those of N3a and N3b, suggesting that N3a and N3b could be combined as new N3. Additionally, the overall survival (OS) curves of stages I, II, III and IVa were not significantly different. Therefore, we propose a new clinical NPC staging standard based on magnetic resonance imaging (MRI) and IMRT as T stage (including T1 and T2), N stage (including N0, N1, N2 and N3) and clinical staging includes I (T1N0M0), II (T1N1-2M0, T2N0M0), III (T2N1-2M0), IVa (TxN3M0) and IVb (TxNxM1). Recommended staging system performs better in risk difference and distribution balance. Furthermore, the differences in the 5-year curves of local relapse-free survival (LRFS), distant metastasis-free survival (DMFS), and OS were all statistically more significant than the seventh edition of the UICC/AJCC staging system. Conclusions Proposed staging system is more adaptable to IMRT and predicts the prognosis of NPC patients more accurately. PMID:26918446

  10. Using low-cost Android tablets and instructional videos to teach clinical skills to medical students in Kenya: a prospective study

    PubMed Central

    Ahn, Roy; Nelson, Brett D; Kagan, Calvin; Burke, Thomas F

    2016-01-01

    Objectives To assess the feasibility and impact of using a low-cost Android tablet to deliver clinical skills training to third-year medical students in Kenya. Design A prospective study using a low cost tablet called ‘connecTAB’, which was designed and manufactured specifically for areas with low bandwidth. Instructional video tutorials demonstrating techniques of cardiovascular and abdominal clinical examinations were pre-loaded onto the tablet. Setting Maseno University School of Medicine, Western Kenya. Participants Fifty-one third-year medical students from Maseno University School of Medicine were subjects in the study. Twenty-five students were assigned to the intervention group and 26 to the control group. Main outcome measures At the start of the study, students from both groups completed an Observed Structured Clinical Examination (OSCE) of the cardiovascular and abdominal evaluations. Students who were allocated to the intervention group then received the connecTAB, whereas students in the control group did not. After a period of three weeks, students from both groups completed a post-study OSCE for both the cardiovascular and abdominal evaluations. Results There were significantly higher improvements in the scores for both cardiovascular and abdominal examinations (p < 0.001) within the group who received the e-tablets as compared to the control group. Conclusion The study suggests that access to connecTAB improves clinical education and efficacy and holds promise for international training in both medical and allied healthcare professional spheres in resource-limited settings. PMID:27540487

  11. Cementless anatomical prosthesis for the treatment of 3-part and 4-part proximal humerus fractures: cadaver study and prospective clinical study with minimum 2 years followup

    PubMed Central

    Obert, Laurent; Saadnia, Rachid; Loisel, François; Uhring, Julien; Adam, Antoine; Rochet, Séverin; Clappaz, Pascal; Lascar, Tristan

    2016-01-01

    Introduction: The purpose of this study was to evaluate the functional and radiological outcomes of a cementless, trauma-specific locked stem for 3- and 4-part proximal humeral fractures. Materials and methods: This study consisted of two parts: a cadaver study with 22 shoulders and a multicenter prospective clinical study of 23 fracture patients evaluated at least 2 years after treatment. In the cadaver study, the locked stem (HumelockTM, FX Solutions) and its instrumentation were evaluated. In the clinical study, five senior surgeons at four different hospitals performed the surgical procedures. An independent surgeon evaluated the patients using clinical (Constant score, QuickDASH) and radiological (X-rays, CT scans) outcome measures. Results: The cadaver study allowed us to validate the height landmarks relative to the pectoralis major tendon. In the clinical study, at the review, abduction was 95° (60–160), forward flexion was 108° (70–160), external rotation (elbow at body) was 34° (0–55), the QuickDASH was 31 (4.5–59), the overall Constant score was 54 (27–75), and the weighted Constant score was 76 (31.5–109). Discussion: This preliminary study of hemiarthroplasty (HA) with a locked stem found results that were at least equivalent to published series. As all patients had at least a 2-year follow-up, integration of the locked stem did not cause any specific complications. These results suggest that it is possible to avoid using cement when hemiarthroplasty is performed for the humeral stem. This implant makes height adjustment and transosseous suturing of the tuberosities more reproducible. PMID:27194107

  12. A prospective study validating a clinical scoring system and demonstrating phenotypical-genotypical correlations in Silver-Russell syndrome

    PubMed Central

    Azzi, Salah; Salem, Jennifer; Thibaud, Nathalie; Chantot-Bastaraud, Sandra; Lieber, Eli; Netchine, Irène; Harbison, Madeleine D

    2015-01-01

    Background Multiple clinical scoring systems have been proposed for Silver-Russell syndrome (SRS). Here we aimed to test a clinical scoring system for SRS and to analyse the correlation between (epi)genotype and phenotype. Subjects and methods Sixty-nine patients were examined by two physicians. Clinical scores were generated for all patients, with a new, six-item scoring system: (1) small for gestational age, birth length and/or weight ≤−2SDS, (2) postnatal growth retardation (height ≤−2SDS), (3) relative macrocephaly at birth, (4) body asymmetry, (5) feeding difficulties and/or body mass index (BMI) ≤−2SDS in toddlers; (6) protruding forehead at the age of 1–3 years. Subjects were considered to have likely SRS if they met at least four of these six criteria. Molecular investigations were performed blind to the clinical data. Results The 69 patients were classified into two groups (Likely-SRS (n=60), Unlikely-SRS (n=9)). Forty-six Likely-SRS patients (76.7%) displayed either 11p15 ICR1 hypomethylation (n=35; 58.3%) or maternal UPD of chromosome 7 (mUPD7) (n=11; 18.3%). Eight Unlikely-SRS patients had neither ICR1 hypomethylation nor mUPD7, whereas one patient had mUPD7. The clinical score and molecular results yielded four groups that differed significantly overall and for individual scoring system factors. Further molecular screening led identifying chromosomal abnormalities in Likely-SRS-double-negative and Unlikely-SRS groups. Four Likely-SRS-double negative patients carried a DLK1/GTL2 IG-DMR hypomethylation, a mUPD16; a mUPD20 and a de novo 1q21 microdeletion. Conclusions This new scoring system is very sensitive (98%) for the detection of patients with SRS with demonstrated molecular abnormalities. Given its clinical and molecular heterogeneity, SRS could be considered as a spectrum. PMID:25951829

  13. Decreased Sperm Motility Retarded ICSI Fertilization Rate in Severe Oligozoospermia but Good-Quality Embryo Transfer Had Achieved the Prospective Clinical Outcomes

    PubMed Central

    Zheng, Jufeng; Lu, Yongning; Qu, Xianqin; Wang, Peng; Zhao, Luiwen; Gao, Minzhi; Shi, Huijuan; Jin, Xingliang

    2016-01-01

    . Overall rates in all groups were 41.26% clinical pregnancy, 25.74% implantation and 36.32% live birth, which gave live birth to 252 girls and 252 boys. Conclusions The reduction of motile spermatozoa in severe oligozoospermia decreased the rates of fertilization and good-quality embryo. Obtaining and transfer of good-quality embryos was the good prognostic to achieve prospective clinical outcomes regardless of the severity of oligozoospermia. PMID:27661081

  14. Temperature thresholds in assessment of the clinical course of acquired cold contact urticaria: a prospective observational one-year study.

    PubMed

    Martinez-Escala, M Estela; Curto-Barredo, Laia; Carnero, Lluïsa; Pujol, Ramon M; Giménez-Arnau, Ana M

    2015-03-01

    Cold contact urticaria is the second most common subtype of physical urticaria. Cold stimulation standardized tests are mandatory to confirm the diagnosis. The aim of this study is to define the utility of determining thresholds (critical time and temperature) in assessment of the clinical course of typical acquired cold contact urticaria. Nineteen adult patients (10 women and 9 men; mean age 45 years) were included in the study and the diagnosis was confirmed with the ice-cube test and TempTest 3.0. Patients were treated continuously for 1 year with 20 mg/day rupatadine (anti-H1). Thresholds measurements were made before and after treatment. Improvements in temperature and critical time thresholds were found in the study sample, demonstrating the efficacy of continuous treatment with rupatadine. In most cases association with a clinical improvement was found. We propose an algorithm for the management of acquired cold contact urticaria based on these results.

  15. Clinical experience with the meningococcal B vaccine, Bexsero(®): Prospects for reducing the burden of meningococcal serogroup B disease.

    PubMed

    Watson, Philip S; Turner, David P J

    2016-02-10

    Although rare, invasive meningococcal disease remains an important cause of mortality and morbidity in children and young adults. Vaccines have been successfully introduced to help protect against meningococcal disease caused by serogroups A, C, W and Y, but until recently, a vaccine for serogroup B (MenB) was not available. In many industrialised countries, MenB causes the majority of meningococcal disease. Moreover, MenB outbreaks occur unpredictably, particularly in high-risk populations, such as university students. In 2013, Bexsero(®) became the first broad-coverage vaccine to be licensed for active immunisation against MenB disease. Bexsero is now licensed in more than 35 countries worldwide for varying age groups, including the EU, Australia, Brazil, Canada, Chile, Uruguay and the USA. Clinical recommendations for the use of Bexsero have been published in several countries. Recommendations include use in high-risk groups, outbreak control and routine infant immunisation. Since initial licensure, considerable clinical experience has been gained. In Canada, 43,740 individuals received Bexsero during a vaccination programme in the Saguenay-Lac-Saint-Jean region of Quebec, where local disease incidence was high. In the USA, Bexsero was administered to >15,000 individuals during two college outbreaks prior to licensure, under an Investigational New Drug protocol. In the UK, the Joint Committee on Vaccination and Immunisation has recommended the inclusion of Bexsero in the routine immunisation schedule for infants. Publically funded vaccination programmes have been initiated in Italy, and there has been widespread use of the vaccine outside of publically reimbursed programmes. Overall, >1,000,000 doses of Bexsero have been distributed in 19 countries worldwide since 2013. The emerging clinical experience with Bexsero is consistent with findings from pre-licensure clinical studies, and no new safety concerns have been identified. Additional data on length of

  16. Clinical experience with the meningococcal B vaccine, Bexsero(®): Prospects for reducing the burden of meningococcal serogroup B disease.

    PubMed

    Watson, Philip S; Turner, David P J

    2016-02-10

    Although rare, invasive meningococcal disease remains an important cause of mortality and morbidity in children and young adults. Vaccines have been successfully introduced to help protect against meningococcal disease caused by serogroups A, C, W and Y, but until recently, a vaccine for serogroup B (MenB) was not available. In many industrialised countries, MenB causes the majority of meningococcal disease. Moreover, MenB outbreaks occur unpredictably, particularly in high-risk populations, such as university students. In 2013, Bexsero(®) became the first broad-coverage vaccine to be licensed for active immunisation against MenB disease. Bexsero is now licensed in more than 35 countries worldwide for varying age groups, including the EU, Australia, Brazil, Canada, Chile, Uruguay and the USA. Clinical recommendations for the use of Bexsero have been published in several countries. Recommendations include use in high-risk groups, outbreak control and routine infant immunisation. Since initial licensure, considerable clinical experience has been gained. In Canada, 43,740 individuals received Bexsero during a vaccination programme in the Saguenay-Lac-Saint-Jean region of Quebec, where local disease incidence was high. In the USA, Bexsero was administered to >15,000 individuals during two college outbreaks prior to licensure, under an Investigational New Drug protocol. In the UK, the Joint Committee on Vaccination and Immunisation has recommended the inclusion of Bexsero in the routine immunisation schedule for infants. Publically funded vaccination programmes have been initiated in Italy, and there has been widespread use of the vaccine outside of publically reimbursed programmes. Overall, >1,000,000 doses of Bexsero have been distributed in 19 countries worldwide since 2013. The emerging clinical experience with Bexsero is consistent with findings from pre-licensure clinical studies, and no new safety concerns have been identified. Additional data on length of

  17. Comparison between caudal bupivacaine and bupivacaine with ketamine for postoperative analgesia in children: A prospective randomized clinical study

    PubMed Central

    Kaur, Depinder; Anand, Saurabh

    2016-01-01

    Background: Efficacy of caudal bupivacaine plus ketamine on postoperative pain in children. Aims: The aim of this study was to compare the analgesic efficacy and safety of caudal block with mixture of bupivacaine and ketamine to bupivacaine alone for postoperative analgesia in pediatric patients undergoing infraumbilical surgery. Settings and Design: A prospective randomized study was conducted in a tertiary care teaching hospital. Statistical Analysis: Data were collected; mean value and standard deviation were computed for age, weight, duration of surgery, and duration of analgesia. Then, the mean values of the two groups were compared using ANOVA. P < 0.05 was considered statistically significant. Materials and Methods: A total of 60 American Society of Anesthesiologists I and II pediatric patients of either sex, aged 1–10 years, undergoing herniotomy, orchidopexy, and urethroplasty were randomly allocated to receive one of the two analgesic regimens. Group A (30 patients) received caudal bupivacaine 0.25% in a dose of 1 ml/kg, and Group B received caudal block with 0.25% bupivacaine 1 ml/kg and preservative-free ketamine 0.5 mg/kg; duration of analgesia was recorded by objective pain scale to equate pain and discomfort in young children with changes in standardized behavioral and physiological parameters. Results: Mean duration of analgesia in Group A was 5.63 ± 0.98 h while the mean duration of analgesia in Group B was 10.18 ± 2.24 h with P < 0.001. There were no differences between groups in the incidence of motor block and side effects. Conclusion: On the basis of results derived from this study, it is concluded that addition of ketamine 0.5 mg/kg to caudal bupivacaine 0.25% in a dose of 1 ml/kg significantly prolonged the postoperative analgesia compared with administration of caudal bupivacaine 0.25% in a dose of 1 ml/kg alone. PMID:27746538

  18. Role of Adaptive Radiotherapy During Concomitant Chemoradiotherapy for Lung Cancer: Analysis of Data From a Prospective Clinical Trial

    SciTech Connect

    Spoelstra, Femke; Pantarotto, Jason R.; Soernsen de Koste, John R. van; Slotman, Ben J.; Senan, Suresh

    2009-11-15

    Purpose: Respiratory-gated radiotherapy allows for the reduction of the toxicity associated with concomitant chemoradiotherapy, but the smaller fields used could increase the risk of missing the target. A prospective study was performed to evaluate the dosimetric consequences of time-trend changes in patients with lung cancer who were treated with concomitant chemoradiotherapy. Methods and Materials: A total of 24 lung cancer patients eligible for chemoradiotherapy and gated delivery underwent four-dimensional computed tomography (4D-CT) after 15 fractions. This scan was co-registered with the initial planning 4D-CT and a new planning target volume (PTV) was generated on the basis of the tumor visualized after 15 fractions. Coverage of the repeat PTV was evaluated by applying the original plan to the second scan and recalculating the dose. Plan modification was triggered by a 5% reduction in the PTV included within the 95% isodose volume or an unacceptable increase in the critical organ dose. Results: Of the 21 evaluable patients, 15 had an average reduction in the PTV of 8% after 30 Gy. The PTV increased in the remaining 6 patients, but the increase was >20% in only 1 patient. In the latter patient, disease progression was observed, and repeat planning was required. The plans created using the new PTV were acceptable in all the other patients. Conclusion: The role of adaptive radiotherapy appears limited when respiratory-gated radiotherapy is used to reduce the toxicity related to concomitant chemoradiotherapy. The use of more conformal treatment techniques might provide the rationale for repeat imaging as a method to identify patients at risk of dosimetric miss.

  19. Prospective Association of Intimate Partner Violence with Receipt of Clinical Preventive Services in Women of Reproductive Age

    PubMed Central

    McCall-Hosenfeld, Jennifer S.; Chuang, Cynthia H.; Weisman, Carol S.

    2013-01-01

    Background Women who experience intimate partner violence (IPV) have a greater risk for adverse health outcomes, suggesting the importance of preventive services in this group. Little prior research has explored how IPV exposure impacts receipt of relevant preventive services. We assess the prospective association of IPV exposure with receiving specific preventive services. Methods Women in the Central Pennsylvania Women’s Health Study’s longitudinal cohort study (conducted 2004–2007; n = 1,420) identified past-year exposure to IPV at baseline and receipt of IPV-relevant preventive services (counseling for safety and violence concerns, tests for sexually transmitted infections [STIs], counseling for STIs, Pap testing, counseling for smoking/tobacco use, alcohol/drug use, and birth control) at 2-year follow-up. Multiple logistic regression analysis assessed the impact of IPV on service receipt, controlling for relevant covariates. Findings Women exposed to IPV had greater odds of receiving safety and violence counseling (adjusted odds ratio [AOR], 2.40; 95% confidence interval [CI], 1.25–4.61), and tests for STIs (AOR, 2.46; 95% CI, 1.41–4.28) compared with women who had not been exposed to IPV. Independent of other predictors, including IPV, women who saw an obstetrician-gynecologist were more likely to receive Pap tests, STI/HIV testing and counseling, and birth control counseling, compared with women who had not seen an obstetrician-gynecologist. Conclusion Overall rates of preventive service receipt for all women in the sample were low. Women exposed to IPV were more likely to receive safety and violence counseling and STI testing, and seeing an obstetrician-gynecologist increased the odds of receiving several preventive services. PMID:23481691

  20. A comparative in-vivo evaluation of the alignment efficiency of 5 ligation methods: A prospective randomized clinical trial

    PubMed Central

    Reddy, Vijaya Bhaskara; Kumar, Talapaneni Ashok; Prasad, Mandava; Nuvvula, Sivakumar; Patil, Rajedra Goud; Reddy, Praveen Kumar

    2014-01-01

    Objectives: To conduct a prospective randomized study comparing the efficiency of 5 different ligation systems (ELL; elastomeric ligature, SSL; stainless steel ligature, LL; leone slide ligature, PSL; passive self-ligation and ASL; active self-ligation) over the duration of mandibular crowding alleviation. Materials and Methods: Fifty consecutive patients (54.2% male, 45.8% female; mean age: 16.69 years) satisfying the inclusion criteria were randomly allocated to 5 ligation groups with an equal sample size of 10 per group. The 5 groups received treatment with 0.022-inch MBT pre-adjusted edge-wise technique (ELL: Gemini 3M Unitek, SSL: Gemini 3M Unitek, LL: Gemini 3M Unitek, PSL: SmartClip 3M Unitek and ASL: In-Ovation R Euro GAC International). The models and cephalograms were evaluated for anterior arch alignment, extraction space closure, and lower incisal inclinations at pre-treatment T1 and at the end of initial alignment T2. Analysis of variance (ANOVA) and Post-hoc tests were used for data analysis. Results: Forty-eight participants completed the study, and SL systems showed a significant difference over CL groups in time to alignment, passive space closure, and incisal inclination. Multiple regression showed a reduction of 5.28 days in time to alignment by changing the ligation group in the order of ELL to ASL group and 1 mm increase in initial irregularity index increases time to alignment by 11.68 days. Conclusion: Self-ligation brackets were more efficient than conventional ligation brackets during initial leveling and alignment. PMID:24966742

  1. Associations between metabolic syndrome and clinical benign prostatic hyperplasia in a northern urban Han Chinese population: A prospective cohort study

    PubMed Central

    Zhao, Si-Cong; Xia, Ming; Tang, Jian-Chun; Yan, Yong

    2016-01-01

    Biologic rationales exist for the associations between metabolic syndrome (MetS) and benign prostatic hyperplasia (BPH). However, epidemiologic studies have yield inconsistent results. The aim of the present study was to prospectively evaluate the associations of MetS with the risk of BPH. The presence of MetS, the number of MetS components, and the individual MetS components were evaluated. After adjusting for potential confounders, MetS was associated with increased risk of BPH (HR: 1.29; 95% CI, 1.08–1.50; p < 0.001). Compared with subjects without any MetS components, the HRs were 0.88 (95% CI, 0.67–1.09; p = 0.86), 1.18 (95% CI, 0.89–1.47; p = 0.29) and 1.37 (95% CI, 1.08–1.66; p = 0.014) for subjects with 1, 2, or ≥3 MetS components, and there was a biologic gradient between the number of MetS components and the risk of BPH (p-trend < 0.001). Central obesity and low high-density lipoprotein cholesterol were the two main divers of the associations between these two conditions, with HRs of 1.93 (95% CI, 1.14–2.72; p = 0.001) for central obesity, and 1.56 (95% CI, 1.08–2.04; p = 0.012) for low HDL-C. Our findings support the notion that MetS may be an important target for BPH prevention and intervention. PMID:27653367

  2. Dermal scarification versus intramuscular diclofenac sodium injection for the treatment of renal colic: a prospective randomized clinical trial.

    PubMed

    Ioannidis, Stavros; Kampantais, Spyridon; Ioannidis, Anastasios; Gkagkalidis, Konstantinos; Vakalopoulos, Ioannis; Toutziaris, Chrysovalantis; Patsialas, Christos; Laskaridis, Leonidas; Dimopoulos, Panagiotis; Dimitriadis, Georgios

    2014-12-01

    The aim of the study is to determine whether dermal scarification is equally effective for treating acute renal colic compared to diclofenac sodium intramuscular therapy. A prospective, randomized controlled study was conducted with methodologic rigor based on CONSORT criteria. A total of 291 patients, aged ≥ 18 years, suffering from acute renal colic were included in this trial and randomly assigned in two groups. Patients in the first group (A) received endodermal injection (dermal scarification) of 1 ml normal saline at the area of intensity of pain. The second group (B) received 75 mg diclofenac sodium by intramuscular injection. The success of each method defined the primary end point. Pain intensity before and after treatment was assessed using a visual analog scale. The time onset and the duration of analgesia were also recorded. There was no significant difference between the two groups regarding hematuria (p = 0.158), stone identification at KUB (p = 0.751) and mean pain intensity (p = 0.609) before treatment initiation. The method was successful in 75.5 % of patients in group A and 74.3 % of patients in group B (p = 0.812). Mean pain reduction was comparable, 5.65 ± 3.05 in group A and 5.34 ± 2.99 in group B (p = 0.379), with dermal scarification eliciting its effect considerably faster, whereas the duration of analgesia was longer in the diclofenac group (p < 0.05). In conclusion, dermal scarification could constitute an alternative method for treating renal colic as it is equally effective compared to the standard treatment of diclofenac sodium.

  3. Increased erythrocyte aggregation as an indicator for an aggressive clinical course in Behçet's disease: a prospective study

    PubMed Central

    Demiroglu, H.; Yalcin, S.; Buyukasik, Y.; Ozcebe, O. I.; Dundar, S.

    1998-01-01

    OBJECTIVE—Changes in blood rheology, especially increased erythrocyte aggregation (EA) might play an important part in the development of arterial and venous thrombotic lesions. A prospective study was designed to evaluate EA in patients with Behçet's disease (BD) and to see if this parameter is predictive for the future development of vascular complications, such as deep vein thrombosis of various organ systems and uveitis.
METHODS—EA was measured by a photometric Myrenne aggregometer in 38 patients with BD at the time of initial diagnosis and in 40 age and sex matched healthy controls (HC).
RESULTS—During a median follow up period of 13.5 months, 13 patients developed vascular-ocular complications (eight deep vein thrombosis, nine uveitis, and four both deep vein thrombosis and uveitis). Patients were further divided into two groups: BD-a with mucocutaneous symptoms and arthritis only; BD-b with associated vascular-ocular complications. EA values at high shear rate (M) and at low shear rate (M1) were compared among the groups.
CONCLUSION—EA values at M and M1 were significantly higher in BD-b than BD-a and HC (p<0.001). These results suggest that determination of EA rates might be useful to identify subgroups who are likely candidates for developing vascular-ocular complications in BD and management of factors known to affect blood rheology might be beneficial.

 Keywords: erythrocyte aggregation; Behcet's syndrome PMID:9924214

  4. GFAP-BDP as an Acute Diagnostic Marker in Traumatic Brain Injury: Results from the Prospective Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study

    PubMed Central

    Yue, John K.; Puccio, Ava M.; Panczykowski, David M.; Inoue, Tomoo; McMahon, Paul J.; Sorani, Marco D.; Yuh, Esther L.; Lingsma, Hester F.; Maas, Andrew I.R.; Valadka, Alex B.; Manley, Geoffrey T.; Casey, Scott S.; Cheong, Maxwell; Cooper, Shelly R.; Dams-O'Connor, Kristen; Gordon, Wayne A.; Hricik, Allison J.; Hochberger, Kerri; Menon, David K.; Mukherjee, Pratik; Sinha, Tuhin K.; Schnyer, David M.; Vassar, Mary J.

    2013-01-01

    Abstract Reliable diagnosis of traumatic brain injury (TBI) is a major public health need. Glial fibrillary acidic protein (GFAP) is expressed in the central nervous system, and breakdown products (GFAP-BDP) are released following parenchymal brain injury. Here, we evaluate the diagnostic accuracy of elevated levels of plasma GFAP-BDP in TBI. Participants were identified as part of the prospective Transforming Research And Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Study. Acute plasma samples (<24 h post-injury) were collected from patients presenting with brain injury who had CT imaging. The ability of GFAP-BDP level to discriminate patients with demonstrable traumatic lesions on CT, and with failure to return to pre-injury baseline at 6 months, was evaluated by the area under the receiver operating characteristic curve (AUC). Of the 215 patients included for analysis, 83% had mild, 4% had moderate, and 13% had severe TBI; 54% had acute traumatic lesions on CT. The ability of GFAP-BDP level to discriminate patients with traumatic lesions on CT as evaluated by AUC was 0.88 (95% confidence interval [CI], 0.84–0.93). The optimal cutoff of 0.68 ng/mL for plasma GFAP-BDP level was associated with a 21.61 odds ratio for traumatic findings on head CT. Discriminatory ability of unfavorable 6 month outcome was lower, AUC 0.65 (95% CI, 0.55–0.74), with a 2.07 odds ratio. GFAP-BDP levels reliably distinguish the presence and severity of CT scan findings in TBI patients. Although these findings confirm and extend prior studies, a larger prospective trial is still needed to validate the use of GFAP-BDP as a routine diagnostic biomarker for patient care and clinical research. The term “mild” continues to be a misnomer for this patient population, and underscores the need for evolving classification strategies for TBI targeted therapy. (ClinicalTrials.gov number NCT01565551; NIH Grant 1RC2 NS069409) PMID:23489259

  5. GFAP-BDP as an acute diagnostic marker in traumatic brain injury: results from the prospective transforming research and clinical knowledge in traumatic brain injury study.

    PubMed

    Okonkwo, David O; Yue, John K; Puccio, Ava M; Panczykowski, David M; Inoue, Tomoo; McMahon, Paul J; Sorani, Marco D; Yuh, Esther L; Lingsma, Hester F; Maas, Andrew I R; Valadka, Alex B; Manley, Geoffrey T

    2013-09-01

    Reliable diagnosis of traumatic brain injury (TBI) is a major public health need. Glial fibrillary acidic protein (GFAP) is expressed in the central nervous system, and breakdown products (GFAP-BDP) are released following parenchymal brain injury. Here, we evaluate the diagnostic accuracy of elevated levels of plasma GFAP-BDP in TBI. Participants were identified as part of the prospective Transforming Research And Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Study. Acute plasma samples (<24 h post-injury) were collected from patients presenting with brain injury who had CT imaging. The ability of GFAP-BDP level to discriminate patients with demonstrable traumatic lesions on CT, and with failure to return to pre-injury baseline at 6 months, was evaluated by the area under the receiver operating characteristic curve (AUC). Of the 215 patients included for analysis, 83% had mild, 4% had moderate, and 13% had severe TBI; 54% had acute traumatic lesions on CT. The ability of GFAP-BDP level to discriminate patients with traumatic lesions on CT as evaluated by AUC was 0.88 (95% confidence interval [CI], 0.84-0.93). The optimal cutoff of 0.68 ng/mL for plasma GFAP-BDP level was associated with a 21.61 odds ratio for traumatic findings on head CT. Discriminatory ability of unfavorable 6 month outcome was lower, AUC 0.65 (95% CI, 0.55-0.74), with a 2.07 odds ratio. GFAP-BDP levels reliably distinguish the presence and severity of CT scan findings in TBI patients. Although these findings confirm and extend prior studies, a larger prospective trial is still needed to validate the use of GFAP-BDP as a routine diagnostic biomarker for patient care and clinical research. The term "mild" continues to be a misnomer for this patient population, and underscores the need for evolving classification strategies for TBI targeted therapy. (ClinicalTrials.gov number NCT01565551; NIH Grant 1RC2 NS069409).

  6. Postmortem CT is more accurate than clinical diagnosis for identifying the immediate cause of death in hospitalized patients: a prospective autopsy-based study.

    PubMed

    Inai, Kunihiro; Noriki, Sakon; Kinoshita, Kazuyuki; Sakai, Toyohiko; Kimura, Hirohiko; Nishijima, Akihiko; Iwasaki, Hiromichi; Naiki, Hironobu

    2016-07-01

    Despite 75 to 90 % physician accuracy in determining the underlying cause of death, precision of determination of the immediate cause of death is approximately 40 %. In contrast, two thirds of immediate causes of death in hospitalized patients are correctly diagnosed by postmortem computed tomography (CT). Postmortem CT might provide an alternative approach to verifying the immediate cause of death. To evaluate the effectiveness of postmortem CT as an alternative method to determine the immediate cause of death in hospitalized patients, an autopsy-based prospective study was performed. Of 563 deaths from September 2011 to August 2013, 50 consecutive cadavers undergoing hospital autopsies with consent for additional postmortem CT at the University of Fukui were enrolled. The accuracy of determination of the immediate cause of death by postmortem CT was evaluated in these patients. Diagnostic discrepancy was also compared between radiologists and attending physicians. The immediate cause of death was correctly diagnosed in 37 of 50 subjects using postmortem CT (74 %), concerning 29 cases of respiratory failure, 4 of hemorrhage, 3 of liver failure and 1 of septic shock. Six cases of organ failure involving 13 patients were not identified as the cause of death by postmortem CT. Regarding the immediate cause of death, accuracy of clinical diagnosis was significantly lower than that of postmortem CT (46 vs 74 %, P < 0.01). Postmortem CT may be more useful than clinical diagnosis for identifying the immediate cause of death in hospitalized patients not undergoing autopsy. PMID:27085336

  7. Nutritional support of bone marrow transplant recipients: a prospective, randomized clinical trial comparing total parental nutrition to an enteral feeding program

    SciTech Connect

    Szeluga, D.J.

    1985-01-01

    Allogeneic and autologous bone marrow transplantation (BMT) have been associated with nutritionally-depleting side effects. Total parental nutrition (TPN) has become the standard, but it has not been demonstrated that TPN is the appropriate method of nutritional support. Therefore, in a prospective, randomized clinical trial TPN and enteral feeding were compared for their effectiveness in maintaining the nutritional status of patients through the first 29 post-transplant days. Nutritional assessment included measurement of serum proteins, body weight, anthropometry and isotope dilution analysis of body composition. Total body water (TBW) and extracellular fluid (ECF) were quantified by standard radioisotope dilution techniques using tritiated water and /sup 169/ytterbium-diethylenetriaminepentaacetate, respectively as the tracers. Consenting patients 10-58 years of age were stratified by type of BMT (autologous or allogeneic) and randomized to either TPN plus ad libitum oral feeding or the individualized enteral feeding program (EFP), which included one-on-one counseling, meal-by-meal menu selection, special snacks and tube feeding. There were no differences in the rate of hematologic recovery, incidence of graft-versus-host disease, organ toxicity, length of hospitalization or survival. Therefore, the observed changes in body composition were not clinically significant. Even allowing for increased dietary service, the EFP was only half as expensive as TPN. It was concluded that TPN is not superior to the EFP and therefore, TPN should be reserved for patients who demonstrate intolerance to enteral feeding.

  8. Effects of oil-based and oil-free enamel prophylactic agents on bracket failure--a prospective randomized clinical trial.

    PubMed

    Magnius, Magdalena; Bazargani, Farhan

    2014-01-01

    This study evaluates and compares the effects of enamel prophylaxis using either oil-free pumice or oil-containing prophylaxis paste on the incidence of bracket failure in orthodontic patients. Forty-six orthodontic patients participated in this prospective clinical trial. A cross-mouth method was used in each patient, in which two diagonal quadrants (i.e. upper right and lower left or vice versa) were randomly assigned to the pumice group and the contralateral diagonal quadrants to the Prophy Paste group. A total of 836 teeth were bonded using Transbond XT (3M Unitek) and monitored for an average of 23 months for bond failure. Chi-square analysis was used to compare the number of bracket failures between the groups. Overall, 26 bond failures occurred by the end of the trial. Fifteen bracket failures were observed in the Prophy Paste group (3.6%) and 11 in the pumice group (2.6%). The failure rates were fairly evenly distributed between the upper and lower jaws. There were no statistically significant differences between the groups (P = 0.43). This study showed that enamel prophylaxis using either pumice or Prophy Paste before orthodontic bonding works equally well in a clinical setting.

  9. Effects of oil-based and oil-free enamel prophylactic agents on bracket failure--a prospective randomized clinical trial.

    PubMed

    Magnius, Magdalena; Bazargani, Farhan

    2014-01-01

    This study evaluates and compares the effects of enamel prophylaxis using either oil-free pumice or oil-containing prophylaxis paste on the incidence of bracket failure in orthodontic patients. Forty-six orthodontic patients participated in this prospective clinical trial. A cross-mouth method was used in each patient, in which two diagonal quadrants (i.e. upper right and lower left or vice versa) were randomly assigned to the pumice group and the contralateral diagonal quadrants to the Prophy Paste group. A total of 836 teeth were bonded using Transbond XT (3M Unitek) and monitored for an average of 23 months for bond failure. Chi-square analysis was used to compare the number of bracket failures between the groups. Overall, 26 bond failures occurred by the end of the trial. Fifteen bracket failures were observed in the Prophy Paste group (3.6%) and 11 in the pumice group (2.6%). The failure rates were fairly evenly distributed between the upper and lower jaws. There were no statistically significant differences between the groups (P = 0.43). This study showed that enamel prophylaxis using either pumice or Prophy Paste before orthodontic bonding works equally well in a clinical setting. PMID:25102719

  10. Inhibition of DPP4 activity in humans establishes its in vivo role in CXCL10 post-translational modification: prospective placebo-controlled clinical studies.

    PubMed

    Decalf, Jérémie; Tarbell, Kristin V; Casrouge, Armanda; Price, Jeffrey D; Linder, Grace; Mottez, Estelle; Sultanik, Philippe; Mallet, Vincent; Pol, Stanislas; Duffy, Darragh; Albert, Matthew L

    2016-01-01

    Biochemical experiments, animal models, and observational studies in humans all support a role of dipeptidyl peptidase 4 (DPP4) in the N-terminal truncation of CXCL10, which results in the generation of an antagonist form of the chemokine that limits T-cell and NK cell migration. Motivated by the ability to regulate lymphocyte trafficking in vivo, we conducted two prospective clinical trials to test the effects of DPP4 inhibition on CXCL10 processing in healthy donors and in chronic hepatitis C patients, a disease in which DPP4 levels are found to be elevated. Participants were treated daily with 100 mg sitagliptin, a clinically approved DPP4 inhibitor. Plasma samples were analyzed using an ultrasensitive single-molecule assay (Simoa) to distinguish the full-length CXCL101-77 from the NH2-truncated CXCL103-77, as compared to the total CXCL10 levels. Sitagliptin treatment resulted in a significant decrease in CXCL103-77 concentration, a reciprocal increase in CXCL101-77, with only minimal effects on total levels of the chemokine. These data provide the first direct evidence that in vivo DPP4 inhibition in humans can preserve the bioactive form of CXCL10, offering new therapeutic opportunities for DPP4 inhibitors.

  11. Inhibition of DPP4 activity in humans establishes its in vivo role in CXCL10 post-translational modification: prospective placebo-controlled clinical studies.

    PubMed

    Decalf, Jérémie; Tarbell, Kristin V; Casrouge, Armanda; Price, Jeffrey D; Linder, Grace; Mottez, Estelle; Sultanik, Philippe; Mallet, Vincent; Pol, Stanislas; Duffy, Darragh; Albert, Matthew L

    2016-01-01

    Biochemical experiments, animal models, and observational studies in humans all support a role of dipeptidyl peptidase 4 (DPP4) in the N-terminal truncation of CXCL10, which results in the generation of an antagonist form of the chemokine that limits T-cell and NK cell migration. Motivated by the ability to regulate lymphocyte trafficking in vivo, we conducted two prospective clinical trials to test the effects of DPP4 inhibition on CXCL10 processing in healthy donors and in chronic hepatitis C patients, a disease in which DPP4 levels are found to be elevated. Participants were treated daily with 100 mg sitagliptin, a clinically approved DPP4 inhibitor. Plasma samples were analyzed using an ultrasensitive single-molecule assay (Simoa) to distinguish the full-length CXCL101-77 from the NH2-truncated CXCL103-77, as compared to the total CXCL10 levels. Sitagliptin treatment resulted in a significant decrease in CXCL103-77 concentration, a reciprocal increase in CXCL101-77, with only minimal effects on total levels of the chemokine. These data provide the first direct evidence that in vivo DPP4 inhibition in humans can preserve the bioactive form of CXCL10, offering new therapeutic opportunities for DPP4 inhibitors. PMID:27137491

  12. Linked Clinical Trials – The Development of New Clinical Learning Studies in Parkinson’s Disease Using Screening of Multiple Prospective New Treatments

    PubMed Central

    Brundin, Patrik; Barker, Roger A.; Conn, P. Jeffrey; Dawson, Ted M.; Kieburtz, Karl; Lees, Andrew J.; Schwarzschild, Michael A.; Tanner, Caroline M.; Isaacs, Tom; Duffen, Joy; Matthews, Helen; Wyse, Richard K.H.

    2015-01-01

    Finding new therapies for Parkinson’s disease (PD) is a slow process. We assembled an international committee of experts to examine drugs potentially suitable for repurposing to modify PD progression. This committee evaluated multiple drugs currently used, or being developed, in other therapeutic areas, as well as considering several natural, non-pharmaceutical compounds. The committee prioritized which of these putative treatments were most suited to move immediately into pilot clinical trials. Aspects considered included known modes of action, safety, blood-brain-barrier penetration, preclinical data in animal models of PD and the possibility to monitor target engagement in the brain. Of the 26 potential interventions, 10 were considered worth moving forward into small, parallel ‘learning’ clinical trials in PD patients. These trials could be funded in a multitude of ways through support from industry, research grants and directed philanthropic donations. The committee-based approach to select the candidate compounds might help rapidly identify new potential PD treatment strategies for use in clinical trials. PMID:24018336

  13. Cosmetic Analysis Following Breast-Conserving Surgery and Adjuvant High-Dose-Rate Interstitial Brachytherapy for Early-Stage Breast Cancer: A Prospective Clinical Study

    SciTech Connect

    Garsa, Adam A.; Ferraro, Daniel J.; DeWees, Todd; Margenthaler, Julie A.; Naughton, Michael; Aft, Rebecca; Gillanders, William E.; Eberlein, Timothy; Matesa, Melissa A.; Zoberi, Imran

    2013-03-15

    Purpose: To prospectively evaluate cosmetic outcomes in women treated with accelerated partial breast irradiation using high-dose-rate interstitial brachytherapy for early-stage breast cancer. Methods and Materials: Between 2004 and 2008, 151 patients with early-stage breast cancer were enrolled in a phase 2 prospective clinical trial. Eligible patients had stage Tis-T2 tumors of ≤3 cm that were excised with negative margins and with no nodal involvement. Patients received 3.4 Gy twice daily to a total dose of 34 Gy. Both the patients and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA). Patients also reported their satisfaction with treatment over time. Results: Median follow-up was 55 months. The rates of excellent-to-good cosmesis reported by patients and the treating radiation oncologist were 92% and 97% pretreatment, 91% and 97% at 3 to 4 months' follow-up, 87% and 94% at 2 years, and 92% and 94% at 3 years, respectively. Breast infection and adjuvant chemotherapy were independent predictors of a fair-to-poor cosmetic outcome at 3 years. Compared to pretreatment pBRA (7.35), there was no significant change in pBRA over time. The volume receiving more than 150 Gy (V150) was the only significant predictor of pBRA. The majority of patients (86.6%) were completely satisfied with their treatment. Conclusions: Patients and the treating physician reported a high rate of excellent-to-good cosmetic outcomes at all follow-up time points. Acute breast infection and chemotherapy were associated with worse cosmetic outcomes. Multicatheter interstitial brachytherapy does not significantly change breast size as measured by pBRA.

  14. A Prospective Longitudinal Clinical Trial Evaluating Quality of Life After Breast-Conserving Surgery and High-Dose-Rate Interstitial Brachytherapy for Early-Stage Breast Cancer

    SciTech Connect

    Garsa, Adam A.; Ferraro, Daniel J.; DeWees, Todd A.; Deshields, Teresa L.; Margenthaler, Julie A.; Cyr, Amy E.; Naughton, Michael; Aft, Rebecca; Gillanders, William E.; Eberlein, Timothy; Matesa, Melissa A.; Ochoa, Laura L.; Zoberi, Imran

    2013-12-01

    Purpose: To prospectively examine quality of life (QOL) of patients with early stage breast cancer treated with accelerated partial breast irradiation (APBI) using high-dose-rate (HDR) interstitial brachytherapy. Methods and Materials: Between March 2004 and December 2008, 151 patients with early stage breast cancer were enrolled in a phase 2 prospective clinical trial. Eligible patients included those with Tis-T2 tumors measuring ≤3 cm excised with negative surgical margins and with no nodal involvement. Patients received 3.4 Gy twice daily to a total dose of 34 Gy. QOL was measured using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, version 3.0, and QLQ-BR23 questionnaires. The QLQ-C30 and QLQ-BR23 questionnaires were evaluated during pretreatment and then at 6 to 8 weeks, 3 to 4 months, 6 to 8 months, and 1 and 2 years after treatment. Results: The median follow-up was 55 months. Breast symptom scores remained stable in the months after treatment, and they significantly improved 6 to 8 months after treatment. Scores for emotional functioning, social functioning, and future perspective showed significant improvement 2 years after treatment. Symptomatic fat necrosis was associated with several changes in QOL, including increased pain, breast symptoms, systemic treatment side effects, dyspnea, and fatigue, as well as decreased role functioning, emotional functioning, and social functioning. Conclusions: HDR multicatheter interstitial brachytherapy was well tolerated, with no significant detrimental effect on measured QOL scales/items through 2 years of follow-up. Compared to pretreatment scores, there was improvement in breast symptoms, emotional functioning, social functioning, and future perspective 2 years after treatment.

  15. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    SciTech Connect

    Liss, Adam L.; Ben-David, Merav A.; Jagsi, Reshma; Hayman, James A.; Griffith, Kent A.; Moran, Jean M.; Marsh, Robin B.; Pierce, Lori J.

    2014-05-01

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique.

  16. Clinical characteristics and significance of Streptococcus salivarius bacteremia and Streptococcus bovis bacteremia: a prospective 16-year study.

    PubMed

    Corredoira, J C; Alonso, M P; García, J F; Casariego, E; Coira, A; Rodriguez, A; Pita, J; Louzao, C; Pombo, B; López, M J; Varela, J

    2005-04-01

    The aim of this study was to determine the clinical significance of Streptococcus salivarius isolates recovered from blood cultures and compare them with isolates of Streptococcus bovis biotypes I and II. Seventeen of the 52 (32%) S. salivarius isolates recovered were considered clinically significant, compared with 62 of the 64 (97%) S. bovis isolates (p<0.0001). Bacteremia caused by S. salivarius occurred mostly in patients who showed relevant disruption of the mucous membranes and/or serious underlying diseases. Patients with S. salivarius bacteremia were younger than those with S. bovis bacteremia (57 vs. 67 years; p<0.01). Patients with S. salivarius bacteremia and patients with S. bovis II bacteremia had similar rates of endocarditis, colon tumors, and non-colon cancer. On the other hand, when compared with S. bovis I bacteremia, S. salivarius bacteremia was associated with lower rates of endocarditis (18% vs. 74%, respectively) (p<0.01) and colon tumors (0% vs. 57%, respectively) (p<0.005) and higher rates of non-colon cancer (53% vs. 9.5%, respectively) (p<0.01). Bacteremia caused by S. bovis II had a hepatobiliary origin in 50% of the patients, while, in contrast, that due to S. salivarius or S. bovis I was less frequently associated with a hepatobiliary origin (12% and 5%, respectively) (p<0.00001). The rate of penicillin resistance was 31% among S. salivarius isolates and 0% among S. bovis isolates (p<0.0001). In conclusion, the clinical characteristics of S. salivarius bacteremia and S. bovis II bacteremia are similar, and the isolation of S. salivarius in blood should not be systematically regarded as contamination. PMID:15902530

  17. CCL19 as a Chemokine Risk Factor for Posttreatment Lyme Disease Syndrome: a Prospective Clinical Cohort Study.

    PubMed

    Aucott, John N; Soloski, Mark J; Rebman, Alison W; Crowder, Lauren A; Lahey, Lauren J; Wagner, Catriona A; Robinson, William H; Bechtold, Kathleen T

    2016-09-01

    Approximately 10% to 20% of patients optimally treated for early Lyme disease develop persistent symptoms of unknown pathophysiology termed posttreatment Lyme disease syndrome (PTLDS). The objective of this study was to investigate associations between PTLDS and immune mediator levels during acute illness and at several time points following treatment. Seventy-six participants with physician-documented erythema migrans and 26 healthy controls with no history of Lyme disease were enrolled. Sixty-four cytokines, chemokines, and inflammatory markers were measured at each visit for a total of 6 visits over 1 year. An operationalized definition of PTLDS incorporating symptoms and functional impact was applied at 6 months and 1 year following treatment completion, and clinical outcome groups were defined as the return-to-health, symptoms-only, and PTLDS groups. Significance analysis of microarrays identified 7 of the 64 immune mediators to be differentially regulated by group. Generalized logit regressions controlling for potential confounders identified posttreatment levels of the T-cell chemokine CCL19 to be independently associated with clinical outcome group. Receiver operating characteristic analysis identified a CCL19 cutoff of >111.67 pg/ml at 1 month following treatment completion to be 82% sensitive and 83% specific for later PTLDS. We speculate that persistently elevated CCL19 levels among participants with PTLDS may reflect ongoing, immune-driven reactions at sites distal to secondary lymphoid tissue. Our findings suggest the relevance of CCL19 both during acute infection and as an immunologic risk factor for PTLDS during the posttreatment phase. Identification of a potential biomarker predictor for PTLDS provides the opportunity to better understand its pathophysiology and to develop early interventions in the context of appropriate and specific clinical information. PMID:27358211

  18. Tinnitus Suppression by Intracochlear Electrical Stimulation in Single Sided Deafness – A Prospective Clinical Trial: Follow-Up

    PubMed Central

    Arts, Remo A. G. J.; George, Erwin L. J.; Janssen, Miranda; Griessner, Andreas; Zierhofer, Clemens; Stokroos, Robert J.

    2016-01-01

    Introduction Earlier studies show that a Cochlear Implant (CI), capable of providing intracochlear electrical stimulation independent of environmental sounds, appears to suppress tinnitus at least for minutes. The current main objective is to compare the long-term suppressive effects of looped (i.e. repeated) electrical stimulation (without environmental sound perception) with the standard stimulation pattern of a CI (with environmental sound perception). This could open new possibilities for the development of a “Tinnitus Implant” (TI), an intracochlear pulse generator for the suppression of tinnitus. Materials and Methods Ten patients with single sided deafness suffering from unilateral tinnitus in the deaf ear are fitted with a CI (MED-EL Corporation, Innsbruck, Austria). Stimulation patterns are optimized for each individual patient, after which they are compared using a randomized crossover design, with a follow-up of six months, followed by a 3 month period using the modality of patient’s choice. Results Results show that tinnitus can be suppressed with intracochlear electrical stimulation independent of environmental sounds, even long term. No significant difference in tinnitus suppression was found between the standard clinical CI and the TI. Conclusion It can be concluded that coding of environmental sounds is no requirement for tinnitus suppression with intracochlear electrical stimulation. It is therefore plausible that tinnitus suppression by CI is not solely caused by an attention shift from the tinnitus to environmental sounds. Both the standard clinical CI and the experimental TI are potential treatment options for tinnitus. These findings offer perspectives for a successful clinical application of the TI, possibly even in patients with significant residual hearing. Trial Registration TrialRegister.nl NTR3374 PMID:27111333

  19. Factors affecting return to sports after anterior cruciate ligament reconstruction with patellar tendon and hamstring graft: a prospective clinical investigation.

    PubMed

    Gobbi, Alberto; Francisco, Ramces

    2006-10-01

    In athletes, anterior cruciate ligament (ACL) reconstruction is recommended after injury to restore the normal knee function and allow subsequent return to sport. Successful ACL reconstruction with patellar tendon (PT) and hamstring tendon (HT) grafts combined with a well-structured rehabilitation program could bring athletes back to their previous level of sport activities. We prospectively followed-up 100 athletes who underwent ACL reconstruction with either PT (n=50) or HT grafts (n=50). Evaluation was done pre-operatively and post-operatively (3, 6, 12, and 24 months) using International Knee Documentation Committee (IKDC), Lysholm, Noyes, and Tegner scales. Subjective assessment numeric evaluation (SANE), knee activity rating scale (Marx) and a psychological profile questionnaire (psychovitality) were also utilized. Objective evaluations included isokinetic tests and computerized knee motion analysis. Data gathered were statistically analyzed using the Mann-Whitney non-parametric U-test. Among the 100 patients who have undergone ACL reconstruction, 65% returned to the same level of sports, 24% changed sports and 11% ceased sport activities. No significant difference (P>0.05) in outcome between PT and HT grafts were observed. No significant differences (P>0.05) were noted between athletes who "returned" to their previous sport and those who "did not return" to sports at the same level when using the IKDC, Lysholm, Noyes, and Tegner knee evaluation scales. However, significant difference was observed with the knee scores obtained by those who returned and those who completely ceased participation in sport activities. Computerized laxity test revealed that 90% of these patients have less than 3 mm side-to-side difference with no significant difference between HT and PT groups. Patients who "returned to sports" obtained significantly better scores with the Marx scale (P=0.001) and the psychovitality questionnaire (P=0.001) than those who did not. Conventional knee

  20. Prospective Evaluation of Dual-Energy Imaging in Patients Undergoing Image Guided Radiation Therapy for Lung Cancer: Initial Clinical Results

    SciTech Connect

    Sherertz, Tracy; Hoggarth, Mark; Luce, Jason; Block, Alec M.; Nagda, Suneel; Harkenrider, Matthew M.; Emami, Bahman; Roeske, John C.

    2014-07-01

    Purpose: A prospective feasibility study was conducted to investigate the utility of dual-energy (DE) imaging compared to conventional x-ray imaging for patients undergoing kV-based image guided radiation therapy (IGRT) for lung cancer. Methods and Materials: An institutional review board-approved feasibility study enrolled patients with lung cancer undergoing IGRT and was initiated in September 2011. During daily setup, 2 sequential respiration-gated x-ray images were obtained using an on-board imager. Imaging was composed of 1 standard x-ray image at 120 kVp (1 mAs) and a second image obtained at 60 kVp (4 mAs). Weighted logarithmic subtraction of the 2 images was performed offline to create a soft tissue-selective DE image. Conventional and DE images were evaluated by measuring relative contrast and contrast-to-noise ratios (CNR) and also by comparing spatial localization, using both approaches. Imaging dose was assessed using a calibrated ion chamber. Results: To date, 10 patients with stage IA to IIIA lung cancer were enrolled and 57 DE images were analyzed. DE subtraction resulted in complete suppression of overlying bone in all 57 DE images, with an average improvement in relative contrast of 4.7 ± 3.3 over that of 120 kVp x-ray images (P<.0002). The improvement in relative contrast with DE imaging was seen for both smaller (gross tumor volume [GTV] ≤5 cc) and larger tumors (GTV >5 cc), with average relative contrast improvement ratios of 3.4 ± 4.1 and 5.4 ± 3.6, respectively. Moreover, the GTV was reliably localized in 95% of the DE images versus 74% of the single energy (SE images, (P=.004). Mean skin dose per DE image set was 0.44 ± 0.03 mGy versus 0.43 ± 0.03 mGy, using conventional kV imaging parameters. Conclusions: Initial results of this feasibility study suggest that DE thoracic imaging may enhance tumor localization in lung cancer patients receiving kV-based IGRT without increasing imaging dose.

  1. Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial.

    PubMed

    Johannesen, L; Vicente, J; Mason, J W; Erato, C; Sanabria, C; Waite-Labott, K; Hong, M; Lin, J; Guo, P; Mutlib, A; Wang, J; Crumb, W J; Blinova, K; Chan, D; Stohlman, J; Florian, J; Ugander, M; Stockbridge, N; Strauss, D G

    2016-02-01

    Drug-induced long QT syndrome has resulted in many drugs being withdrawn from the market. At the same time, the current regulatory paradigm for screening new drugs causing long QT syndrome is preventing drugs from reaching the market, sometimes inappropriately. In this study, we report the results of a first-of-a-kind clinical trial studying late sodium (mexiletine and lidocaine) and calcium (diltiazem) current blocking drugs to counteract the effects of hERG potassium channel blocking drugs (dofetilide and moxifloxacin). We demonstrate that both mexiletine and lidocaine substantially reduce heart-rate corrected QT (QTc) prolongation from dofetilide by 20 ms. Furthermore, all QTc shortening occurs in the heart-rate corrected J-Tpeak (J-Tpeak c) interval, the biomarker we identified as a sign of late sodium current block. This clinical trial demonstrates that late sodium blocking drugs can substantially reduce QTc prolongation from hERG potassium channel block and assessment of J-Tpeak c may add value beyond only assessing QTc. PMID:26259627

  2. Birch pollen influence the severity of atopic eczema – prospective clinical cohort pilot study and ex vivo penetration study

    PubMed Central

    Fölster-Holst, Regina; Galecka, Jagoda; Weißmantel, Sigo; Dickschat, Ute; Rippke, Frank; Bohnsack, Kerstin; Werfel, Thomas; Wichmann, Katja; Buchner, Matthias; Schwarz, Thomas; Vogt, Annika; Lademann, Jürgen; Meinke, Martina C

    2015-01-01

    There is little clinical evidence for a correlation between the severity of atopic eczema (AE) and pollen exposition. To obtain more data, we performed a clinical cohort pilot study about the influence of pollen on AE between sensitized and nonsensitized subjects and an experimental study addressing the cutaneous penetration of pollen into the skin. Fifty-five patients were monitored during birch pollen season. To study the cutaneous penetration, grass pollen allergens were applied on excised skin and the uptake in CD1c-expressing dendritic cells was investigated. The correlation between environmental pollen load and severity of the Scoring Atopic Dermatitis (SCORAD) score and pruritus was observed, regardless of the status of sensitization. The sensitized group recovered significantly worse after the birch pollen season. Remarkably higher amounts of pollen allergens taken up by CD1c cells were detected in epidermal cells derived from skin explants with a disturbed epidermal barrier. These findings suggest an exacerbating role of pollen in AE utilizing the epidermal route. PMID:26604810

  3. A Second Life for eHealth: Prospects for the Use of 3-D Virtual Worlds in Clinical Psychology

    PubMed Central

    Gaggioli, Andrea; Vigna, Cinzia; Riva, Giuseppe

    2008-01-01

    The aim of the present paper is to describe the role played by three-dimensional (3-D) virtual worlds in eHealth applications, addressing some potential advantages and issues related to the use of this emerging medium in clinical practice. Due to the enormous diffusion of the World Wide Web (WWW), telepsychology, and telehealth in general, have become accepted and validated methods for the treatment of many different health care concerns. The introduction of the Web 2.0 has facilitated the development of new forms of collaborative interaction between multiple users based on 3-D virtual worlds. This paper describes the development and implementation of a form of tailored immersive e-therapy called p-health whose key factor is interreality, that is, the creation of a hybrid augmented experience merging physical and virtual worlds. We suggest that compared with conventional telehealth applications such as emails, chat, and videoconferences, the interaction between real and 3-D virtual worlds may convey greater feelings of presence, facilitate the clinical communication process, positively influence group processes and cohesiveness in group-based therapies, and foster higher levels of interpersonal trust between therapists and patients. However, challenges related to the potentially addictive nature of such virtual worlds and questions related to privacy and personal safety will also be discussed. PMID:18678557

  4. Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial.

    PubMed

    Johannesen, L; Vicente, J; Mason, J W; Erato, C; Sanabria, C; Waite-Labott, K; Hong, M; Lin, J; Guo, P; Mutlib, A; Wang, J; Crumb, W J; Blinova, K; Chan, D; Stohlman, J; Florian, J; Ugander, M; Stockbridge, N; Strauss, D G

    2016-02-01

    Drug-induced long QT syndrome has resulted in many drugs being withdrawn from the market. At the same time, the current regulatory paradigm for screening new drugs causing long QT syndrome is preventing drugs from reaching the market, sometimes inappropriately. In this study, we report the results of a first-of-a-kind clinical trial studying late sodium (mexiletine and lidocaine) and calcium (diltiazem) current blocking drugs to counteract the effects of hERG potassium channel blocking drugs (dofetilide and moxifloxacin). We demonstrate that both mexiletine and lidocaine substantially reduce heart-rate corrected QT (QTc) prolongation from dofetilide by 20 ms. Furthermore, all QTc shortening occurs in the heart-rate corrected J-Tpeak (J-Tpeak c) interval, the biomarker we identified as a sign of late sodium current block. This clinical trial demonstrates that late sodium blocking drugs can substantially reduce QTc prolongation from hERG potassium channel block and assessment of J-Tpeak c may add value beyond only assessing QTc.

  5. Maxillary Overdentures Supported by Four Splinted Direct Metal Laser Sintering Implants: A 3-Year Prospective Clinical Study

    PubMed Central

    Mangano, Francesco; Shibli, Jamil Awad; Anil, Sukumaran

    2014-01-01

    Purpose. Nowadays, the advancements in direct metal laser sintering (DMLS) technology allow the fabrication of titanium dental implants. The aim of this study was to evaluate implant survival, complications, and peri-implant marginal bone loss of DMLS implants used to support bar-retained maxillary overdentures. Materials and Methods. Over a 2-year period, 120 implants were placed in the maxilla of 30 patients (18 males, 12 females) to support bar-retained maxillary overdentures (ODs). Each OD was supported by 4 implants splinted by a rigid cobalt-chrome bar. At each annual follow-up session, clinical and radiographic parameters were assessed. The outcome measures were implant failure, biological and prosthetic complications, and peri-implant marginal bone loss (distance between the implant shoulder and the first visible bone-to-implant contact, DIB). Results. The 3-year implant survival rate was 97.4% (implant-based) and 92.9% (patient-based). Three implants failed. The incidence of biological complication was 3.5% (implant-based) and 7.1% (patient-based). The incidence of prosthetic complication was 17.8% (patient-based). No detrimental effects on marginal bone level were evidenced. Conclusions. The use of 4 DMLS titanium implants to support bar-retained maxillary ODs seems to represent a safe and successful procedure. Long-term clinical studies on a larger sample of patients are needed to confirm these results. PMID:25580124

  6. A prospective study of the clinical, genetic, screening, and pathologic features of a family with hereditary mixed polyposis syndrome.

    PubMed

    Rozen, P; Samuel, Z; Brazowski, E

    2003-10-01

    In 1997, hereditary mixed polyposis syndrome (HMPS) was described in an Ashkenazi pedigree having colorectal polyps with mixed histology and risk for colorectal cancer (CRC). The mutation is now localized to 15q13-14. Since 1980, compliant relatives of an HMPS family were seen annually, tested genetically, and had colonoscopy offered every 1 to 2 yr from age 20 yr. The Israeli pedigree has 37 members (17 clinically affected by CRC or polyps), and seven of 13 available relatives entered our screening program. The others, followed-up elsewhere, provided clinical information. Half of our screened group had rectal bleeding; others were asymptomatic. Colonoscopy, performed a mean of four times, identified polyps in all seven patients (mean age 28 yr). Polyps were removed and included juvenile adenomas, mixed juvenile adenomas, hyperplastic polyps, mixed hyperplastic adenomas, serrated adenomas, and tubular adenomas. None of our screened patients developed CRC or extracolonic neoplasia. Linkage analysis localized their mutation to 15q13-14. This high-penetrance founder mutation so far is described only in Ashkenazim. The CRC pathway seems to be through juvenile and hyperplastic polyps. Mutation identification will aid screening for and evaluation of HMPS prevalence in Jewish and non-Jewish populations. Meanwhile, a cancer pedigree and correct classification of polyps will identify HMPS families. They require early and frequent colonoscopy, polypectomy, and elective extensive colectomy when indicated.

  7. A second life for eHealth: prospects for the use of 3-D virtual worlds in clinical psychology.

    PubMed

    Gorini, Alessandra; Gaggioli, Andrea; Vigna, Cinzia; Riva, Giuseppe

    2008-01-01

    The aim of the present paper is to describe the role played by three-dimensional (3-D) virtual worlds in eHealth applications, addressing some potential advantages and issues related to the use of this emerging medium in clinical practice. Due to the enormous diffusion of the World Wide Web (WWW), telepsychology, and telehealth in general, have become accepted and validated methods for the treatment of many different health care concerns. The introduction of the Web 2.0 has facilitated the development of new forms of collaborative interaction between multiple users based on 3-D virtual worlds. This paper describes the development and implementation of a form of tailored immersive e-therapy called p-health whose key factor is interreality, that is, the creation of a hybrid augmented experience merging physical and virtual worlds. We suggest that compared with conventional telehealth applications such as emails, chat, and videoconferences, the interaction between real and 3-D virtual worlds may convey greater feelings of presence, facilitate the clinical communication process, positively influence group processes and cohesiveness in group-based therapies, and foster higher levels of interpersonal trust between therapists and patients. However, challenges related to the potentially addictive nature of such virtual worlds and questions related to privacy and personal safety will also be discussed.

  8. Chemotherapy-radiotherapy association in Hodgkin's disease, clinical stages IA, II/sub 2/A: results of a prospective clinical trial with 166 patients. [/sup 60/Co

    SciTech Connect

    Andrieu, J.M.; Montagnon, B.; Asselain, B.; Bayle-Weisgerber, C.; Chastang, C.; Teillet, F.; Bernard, J.

    1980-11-15

    One hundred sixty-six patients with clinical stages IA, II/sub 2/A Hodgkin's disease were treated between April 1972 and December 1976 with three courses of multiagent chemotherapy (methylchlorethamine, vincristine, procarbazine, prednisone) followed by mantle irradiation - excluding mediastinum for those with initial upper cervical presentation and absence of mediastinal involvement - or inverted Y radiotherapy. With a follow-up of 12 to 84 months, the overall survival is 93.5% and the overall relapse-free survival 89.9%. With chemotherapy-radiotherapy sequence, staging laparotomy is not indicated. Results and side effects of this treatment strategy are compared with those of other treatment policies.

  9. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial

    PubMed Central

    Paratz, Jennifer D; Cohen, Jeremy; Banks, Merrilyn; Dulhunty, Joel; Roberts, Jason A; Lipman, Jeffrey

    2011-01-01

    Background Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. Methods/design Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. Discussion This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of

  10. Development and validation of a clinical score for prognosis stratification in patients requiring antiretroviral therapy in sub-Saharan Africa: a prospective open cohort study

    PubMed Central

    Gerardo, Rivero; Dayana, Pérez

    2011-01-01

    Background Mortality rates among patients initiating antiretroviral therapy (ART) in sub-Saharan Africa continue high. Also HIV treatment services from the region are affronting the challenges of been attending more patients than never. In this scenario, there are no integrated scoring systems capable of an adequate risk identification/ prognostic stratification among patients requiring ART; in order of optimize actual programmes outcomes. Several independent risk factors at baseline are associated with a poor prognosis after ART initiation. These include: male sex, low body mass index, anemia, low CD4 count and stage-4 WHO disease. The aim of this research was evaluate prospectively a new scoring system composed by these factors. Methods An open cohort study was conducted in 1769 patients from May 2008 to December 2010 at two HIV clinics of Zimbabwe. A new clinical model (MASIB score) was applied at ART initiation and patients were followed for 4 months. After that, validation characteristics of the score were examined. Results Patients selected in this cohort exhibited similar baseline characteristics that the patients selected in previous cohorts from the region. Overall performance for mortality prediction of MASIB score was accurate, as reflected by the Brier score test result 0.084 (95%CI: 0.080–0.088). Calibration was adequate taking in consideration a p>0.05 in the Hosmer Lemeshow test and discrimination was also good (Area Under Curve: 0.915, 95%CI: 0,901– 0,928). Conclusion The new model developed exhibited adequate validation characteristics supporting the clinical use. Further evaluations of this model in others scenarios from the sub-Saharan region are needed. PMID:22187587

  11. Adalimumab clinical efficacy is associated with rheumatoid factor and anti-cyclic citrullinated peptide antibody titer reduction: a one-year prospective study

    PubMed Central

    Atzeni, Fabiola; Sarzi-Puttini, Piercarlo; Dell' Acqua, Donata; de Portu, Simona; Cecchini, Germana; Cruini, Carola; Carrabba, Mario; Meroni, Pier Luigi

    2006-01-01

    Studies on autoantibody production in patients treated with tumor necrosis factor-α (TNF-α) inhibitors reported contradictory results. We investigated in a prospective study the efficacy of a treatment with human monoclonal anti-TNF-α antibody (adalimumab) in patients with rheumatoid arthritis (RA) and we evaluated the relationship between treatment efficacy and the incidence and titers of disease-associated and non-organ-specific autoantibodies. Fifty-seven patients with RA not responsive to methotrexate and treated with adalimumab were enrolled. Antinuclear, anti-double-stranded(ds)DNA, anti-extractable nuclear antigens, anti-cardiolipin (aCL), anti-β2 glycoprotein I (anti-β2GPI) autoantibodies, rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) autoantibodies were investigated at baseline and after 6 and 12 months of follow-up. Comparable parameters were evaluated in a further 55 patients treated with methotrexate only. Treatment with adalimumab induced a significant decrease in RF and anti-CCP serum levels, and the decrease in antibody titers correlated with the clinical response to the therapy. A significant induction of antinuclear autoantibodies (ANA) and IgG/IgM anti-dsDNA autoantibodies were also found in 28% and 14.6% patients, respectively, whereas aCL and anti-β2GPI autoantibodies were not detected in significant quantities. No association between ANA, anti-dsDNA, aCL and anti-β2GPI autoantibodies and clinical manifestations was found. Clinical efficacy of adalimumab is associated with the decrease in RF and anti-CCP serum levels that was detected after 24 weeks and remained stable until the 48th week of treatment. Antinuclear and anti-dsDNA autoantibodies, but not anti-phospholipid autoantibodies, can be induced by adalimumab but to a lower extent than in studies with other anti-TNF blocking agents. PMID:16356192

  12. Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

    PubMed Central

    2010-01-01

    Background It has been demonstrated that cognitive behavioural therapy (CBT) has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST) which does not implement CBT-techniques but provides comparable therapeutic attention. Methods/Design The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process), advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency. Discussion This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the international discussion

  13. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial.

    PubMed

    Al Balushi, Ruqaiya M; Paratz, Jennifer D; Cohen, Jeremy; Banks, Merrilyn; Dulhunty, Joel; Roberts, Jason A; Lipman, Jeffrey

    2011-01-01

    Background Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. Methods/design Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. Discussion This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of organ

  14. Anterior cervical fusion with a bio-resorbable composite cage (beta TCP-PLLA): clinical and radiological results from a prospective study on 20 patients.

    PubMed

    Debusscher, F; Aunoble, S; Alsawad, Y; Clement, D; Le Huec, Jean-Charles

    2009-09-01

    A resorbable composite material (40% PLLA and 60% beta TCP) with a high breaking strength and capacity to withstand plastic and elastic strain has been developed for cervical interbody fusion. This is a prospective study to evaluate clinical and radiological results of 20 patients implanted with 27 cages (mean follow-up, 27 months). Clinical (neck disability index, VAS, neurological evaluation) and radiological (anteroposterior, lateral, bending X-rays) data were assessed before and after surgery. At the end of the study, CT scan was performed to evaluate fusion, resorption of the cage and density of the new tissue substituting the cage. The mean patient age was 50.3 years (range, 18-79 years). The average improvement was 55% for neck pain, 83% for arm pain and 65% for NDI, with 85% good or excellent results at final outcomes. Radiologically, lordosis was significantly improved (mean gain of 5.4 degrees and 3.7 degrees for overall and segmental lordosis, respectively). This correction was conserved in 95% of cases. Fusion was obtained in 96% (CT evaluation). Resorption was started in all cases and completed in an average of 36 months after surgery. The mean density of tissue substituting the cage was 659 UH with a range, of 455-911 UH (compatible with bone nature). Over time, the amount of bony tissue increased and the graft remodelled with an increase in density value. This demonstrates a biological activity and changing bone mineral content of this tissue. The new composite cage under investigation provides long-term fusion without loss of correction or inflammatory reaction. The ceramic block guarantees the maintenance of the disc height and its slow resorption allows long-term fusion and stability with good and reliable clinical and radiological outcomes. PMID:19533180

  15. Anterior cervical fusion with a bio-resorbable composite cage (beta TCP–PLLA): clinical and radiological results from a prospective study on 20 patients

    PubMed Central

    Debusscher, F.; Aunoble, S.; Alsawad, Y.; Clement, D.

    2009-01-01

    A resorbable composite material (40% PLLA and 60% beta TCP) with a high breaking strength and capacity to withstand plastic and elastic strain has been developed for cervical interbody fusion. This is a prospective study to evaluate clinical and radiological results of 20 patients implanted with 27 cages (mean follow-up, 27 months). Clinical (neck disability index, VAS, neurological evaluation) and radiological (anteroposterior, lateral, bending X-rays) data were assessed before and after surgery. At the end of the study, CT scan was performed to evaluate fusion, resorption of the cage and density of the new tissue substituting the cage. The mean patient age was 50.3 years (range, 18–79 years). The average improvement was 55% for neck pain, 83% for arm pain and 65% for NDI, with 85% good or excellent results at final outcomes. Radiologically, lordosis was significantly improved (mean gain of 5.4° and 3.7° for overall and segmental lordosis, respectively). This correction was conserved in 95% of cases. Fusion was obtained in 96% (CT evaluation). Resorption was started in all cases and completed in an average of 36 months after surgery. The mean density of tissue substituting the cage was 659 UH with a range, of 455–911 UH (compatible with bone nature). Over time, the amount of bony tissue increased and the graft remodelled with an increase in density value. This demonstrates a biological activity and changing bone mineral content of this tissue. The new composite cage under investigation provides long-term fusion without loss of correction or inflammatory reaction. The ceramic block guarantees the maintenance of the disc height and its slow resorption allows long-term fusion and stability with good and reliable clinical and radiological outcomes. PMID:19533180

  16. Clinical, Laboratorial, and Urodynamic Findings of Prostatic Artery Embolization for the Treatment of Urinary Retention Related to Benign Prostatic Hyperplasia. A Prospective Single-Center Pilot Study

    SciTech Connect

    Antunes, Alberto A.; Carnevale, Francisco C. Motta Leal Filho, Joaquim M. da; Yoshinaga, Eduardo M.; Cerri, Luciana M. O.; Baroni, Ronaldo H.; Marcelino, Antonio S. Z.; Cerri, Giovanni G.; Srougi, Miguel

    2013-08-01

    PurposeThis study was designed to describe the clinical, laboratorial, and urodynamic findings of prostatic artery embolization (PAE) in patients with urinary retention due to benign prostatic hyperplasia (BPH).MethodsA prospective study of 11 patients with urinary retention due to BPH was conducted. Patients underwent physical examination, prostate specific antigen (PSA) measurement, transrectal ultrasound, and magnetic resonance imaging. International prostate symptom score (IPSS), quality of life (QoL), and urodynamic testing were used to assess the outcome before and after 1 year.ResultsClinical success was 91 % (10/11 patients) with a mean follow-up of 22.3 months (range, 12-41 months). At the first year follow-up, the mean IPSS score was 2.8 points (p = 0.04), mean QoL was 0.4 points (p = 0.001), mean PSA decreased from 10.1 to 4.3 ng/mL (p = 0.003), maximum urinary flow (Qmax) improved from 4.2 to 10.8 mL/sec (p = 0.009), and detrusor pressure (Pdet) decreased from 85.7 to 51.5 cm H{sub 2}O (p = 0.007). Before PAE, Bladder Outlet Obstruction Index (BOOI) showed values >40 in 100 % of patients. After PAE, 30 % of patients were >40 (obstructed), 40 % were between 20 and 40 (undetermined), and 30 % were <20 (unobstructed). Patients with a BOOI <20 had higher PSA values at 1-day after PAE.ConclusionsClinical and urodynamic parameters improved significantly after PAE in patients with acute urinary retention due to BPH. Total PSA at day 1 after PAE was higher in patients with unobstructed values in pressure flow studies.

  17. Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial

    PubMed Central

    Bevan, John S.; Petersenn, Stephan; Flanagan, Daniel; Tabarin, Antoine; Prévost, Gaëtan; Maisonobe, Pascal; Clermont, Antoine

    2014-01-01

    Context: Methodological shortcomings often compromise investigations into the effects of primary somatostatin-analog treatment on tumor size in acromegaly. There are also limited data for the long-acting lanreotide formulation. Objective: The aim of the study was to better characterize the effects of primary lanreotide Autogel treatment on tumor size in patients with GH-secreting macroadenomas. Design: PRIMARYS was a 48-week, multicenter, open-label, single-arm study. Setting: The study was conducted at specialist endocrine centers. Patients: Treatment-naïve acromegalic patients with GH-secreting macroadenomas participated in the study. Intervention: Lanreotide Autogel 120 mg was administered sc every 28 days (without dose titration). Outcome Measures: The primary endpoint was the proportion of patients with clinically significant (≥20%) tumor volume reduction (TVR) at week 48/last post-baseline value available using central assessments from three readers. The null hypothesis (H0) for the primary endpoint was that the proportion with TVR was ≤55%. Secondary endpoints included: TVR at other time points, GH and IGF-1, acromegalic symptoms, quality of life (QoL), and safety. Results: Sixty-four of 90 (71.1%) patients completed the study. Clinically significant TVR at 48 weeks/last post-baseline value available was achieved by 62.9% (95% confidence interval, 52.0, 72.9) of 89 patients in the primary analysis (intention-to-treat population; H0 not rejected) and 71.9–75.3% in sensitivity (n = 89) and secondary analyses (n = 63) (H0 rejected). At 12 weeks, 54.1% had clinically significant TVR. Early and sustained improvements also occurred in GH and IGF-1, acromegalic symptoms, and QoL. No patients withdrew due to gastrointestinal intolerance. Conclusions: Primary treatment with lanreotide Autogel, administered at 120 mg (highest available dose) without dose titration, in patients with GH-secreting macroadenomas provides early and sustained reductions in tumor

  18. Cancer and Leukemia Group B Pathology Committee Guidelines for Tissue Microarray Construction Representing Multicenter Prospective Clinical Trial Tissues

    PubMed Central

    Rimm, David L.; Nielsen, Torsten O.; Jewell, Scott D.; Rohrer, Daniel C.; Broadwater, Gloria; Waldman, Frederic; Mitchell, Kisha A.; Singh, Baljit; Tsongalis, Gregory J.; Frankel, Wendy L.; Magliocco, Anthony M.; Lara, Jonathan F.; Hsi, Eric D.; Bleiweiss, Ira J.; Badve, Sunil S.; Chen, Beiyun; Ravdin, Peter M.; Schilsky, Richard L.; Thor, Ann; Berry, Donald A.

    2011-01-01

    Practice-changing evidence requires confirmation, preferably in multi-institutional clinical trials. The collection of tissue within such trials has enabled biomarker studies and evaluation of companion diagnostic tests. Tissue microarrays (TMAs) have become a standard approach in many cooperative oncology groups. A principal goal is to maximize the number of assays with this precious tissue. However, production strategies for these arrays have not been standardized, possibly decreasing the value of the study. In this article, members of the Cancer and Leukemia Group B Pathology Committee relay our experiences as array facility directors and propose guidelines regarding the production of high-quality TMAs for cooperative group studies. We also discuss statistical issues arising from having a proportion of patients available for TMAs and the possibility that patients with TMAs fail to represent the greater study population. PMID:21519016

  19. [Metal/metal--a new (old) hip bearing system in clinical evaluation. Prospective 7-year follow-up study].

    PubMed

    Jessen, N; Nickel, A; Schikora, K; Büttner-Janz, K

    2004-05-01

    The problems of wear debris of bearing systems containing polyethylene used in hip arthroplasty have led to an increased trend to hard on hard bearing surfaces. Based on our own good experiences with the cementless Zweymüller-Alloclassic system, we implanted the same system with metal-on-metal bearing surfaces (Metasul) in 100 cases between October 1993 and November 1994. In order to record potential side effects, specific questioning and a clinical and radiological survey were carried out before surgery and in regular intervals thereafter. Up to date almost all of the patients have had good and excellent results with an average of more than 90 points in the Harris hip score (47.8 before surgery). There were no cases of revision surgery as a result of aseptic loosening. Two revisions were performed for other reasons (change of the insert, deep infection). No disadvantageous phenomena related to Metasul in the surrounding tissue were found on macroscopic and histologic investigation. The radiological examination did not show any specific signs pertaining to the use of a metal-on-metal bearing system. We also have no grounds to suppose that there are systemic reactions due to chromium or cobalt ions. Up to now, the new metal-on-metal bearing system in connection with a proven hip arthroplasty system has lived up to clinical expectations. With regard to less wear debris, it is justified to implant it in younger patients as well. Other open questions, in particular the possibly improved long-term results, have to be answered by continuation of the study. PMID:15118821

  20. The Oxfordshire Community Stroke Project classification system predicts clinical outcomes following intravenous thrombolysis: a prospective cohort study

    PubMed Central

    Yang, Yuling; Wang, Anxin; Zhao, Xingquan; Wang, Chunxue; Liu, Liping; Zheng, Huaguang; Wang, Yongjun; Cao, Yibin; Wang, Yilong

    2016-01-01

    Background The Oxfordshire Community Stroke Project (OCSP) classification system is a simple stroke classification system that can be used to predict clinical outcomes. In this study, we compare the safety and efficacy of intravenous thrombolysis in Chinese stroke patients categorized using the OCSP classification system. Patients and methods We collected data from the Thrombolysis Implementation and Monitoring of Acute Ischemic Stroke in China registry. A total of 1,115 patients treated with intravenous thrombolysis with alteplase within 4.5 hours of stroke onset were included. Symptomatic intracranial hemorrhage (SICH), mortality, and 90-day functional outcomes were compared between the stroke patients with different stroke subtypes. Results Of the 1,115 patients included in the cohort, 197 (17.67%) were classified with total anterior circulation infarct (TACI), 700 (62.78%) with partial anterior circulation infarct, 153 (13.72%) with posterior circulation infarct, and 65 (5.83%) with lacunar infarct. After multivariable adjustment, compared to the patients with non-TACI, those with TACI had a significantly increased risk of SICH (odds ratio [OR] 8.80; 95% confidence interval [CI] 2.84–27.25, P<0.001), higher mortality (OR 5.24; 95% CI 3.19–8.62; P<0.001), and poor functional independence (OR 0.38; 95% CI 0.26–0.56; P<0.001) at 3-month follow-up. Conclusion After thrombolysis, the patients with TACI exhibited greater SICH, a higher mortality rate, and worse 3-month clinical outcomes compared with the patients with non-TACI. The OCSP classification system may help clinicians predict the safety and efficacy of thrombolysis. PMID:27418829

  1. Organ-on-a-chip: development and clinical prospects toward toxicity assessment with an emphasis on bone marrow.

    PubMed

    Kim, Jeehye; Lee, Hanna; Selimović, Šeila; Gauvin, Robert; Bae, Hojae

    2015-05-01

    Conventional approaches for toxicity evaluation of drugs and chemicals, such as animal tests, can be impractical due to the large experimental scale and the immunological differences between species. Organ-on-a-chip models have recently been recognized as a prominent alternative to conventional toxicity tests aiming to simulate the human in vivo physiology. This review focuses on the organ-on-a-chip applications for high-throughput screening of candidate drugs against toxicity, with a particular emphasis on bone-marrow-on-a-chip. Studies in which organ-on-a-chip models have been developed and utilized to maximize the efficiency and predictability in toxicity assessment are introduced. The potential of these devices to replace tests of acute systemic toxicity in animals, and the challenges that are inherent in simulating the human immune system are also discussed. As a promising approach to overcome the limitations, we further focus on an in-depth analysis of the development of bone-marrow-on-a-chip that is capable of simulating human immune responses against external stimuli due to the key roles of marrow in immune systems with hematopoietic activities. Owing to the complex interactions between hematopoietic stem cells and marrow microenvironments, precise control of both biochemical and physical niches that are critical in maintenance of hematopoiesis remains a key challenge. Thus, recently developed bone-marrow-on-a-chip models support immunogenicity and immunotoxicity testing in long-term cultivation with repeated antigen stimulation. In this review, we provide an overview of clinical studies that have been carried out on bone marrow transplants in patients with immune-related diseases and future aspects of clinical and pharmaceutical application of bone-marrow-on-a-chip.

  2. Prospective Comparison of the Clinical Impacts of Heterogeneous Vancomycin-Intermediate Methicillin-Resistant Staphylococcus aureus (MRSA) and Vancomycin-Susceptible MRSA▿ †

    PubMed Central

    Horne, K. C.; Howden, B. P.; Grabsch, E. A.; Graham, M.; Ward, P. B.; Xie, S.; Mayall, B. C.; Johnson, P. D. R.; Grayson, M. L.

    2009-01-01

    Although methicillin (meticillin)-resistant Staphylococcus aureus (MRSA) strains with reduced susceptibility to vancomycin (RVS-MRSA; including vancomycin-intermediate S. aureus [VISA] and heterogeneous VISA [hVISA]) have been linked with vancomycin treatment failure, it is unclear whether they are more pathogenic than vancomycin-susceptible MRSA (VS-MRSA). We prospectively assessed patients with clinical MRSA isolates during a 10-month period to determine clinical status (infection versus colonization) and therapeutic outcome before correlating these findings with the results of detailed in vitro assessment of vancomycin susceptibility, including population analysis profile (PAP) testing. hVISA and VISA were defined by standard PAP criteria (area-under-the-curve ratio compared to that of the reference hVISA strain Mu3 [≥0.9]) and routine CLSI criteria (vancomycin MIC, 4 to 8 μg/ml), respectively. Among the 117 patients assessed, 58 had RVS-MRSA isolates (56 hVISA and 2 VISA) and 59 had VS-MRSA isolates; the patient demographics and comorbidities were similar. RVS-MRSA was associated with a lower rate of infection than VS-MRSA (29/58 versus 46/59; P = 0.003), including a lower rate of bacteremia (3/58 versus 20/59, respectively; P < 0.001). The cure rates in RVS-MRSA and VS-MRSA groups were not statistically different (16/26 versus 31/42; P = 0.43), but the post hoc assessment of treatment regimes and study size made detailed conclusions difficult. The results of the macro method Etest correlated well with the PAP results (sensitivity, 98.3%, and specificity, 91.5%), but broth microdilution and our preliminary RVS-MRSA detection method correlated poorly. All isolates were susceptible to linezolid and daptomycin. These data suggest that detailed prospective laboratory identification of RVS-MRSA isolates may be of limited value and that, instead, such in vitro investigation should be reserved for isolates from patients who are failing appropriate anti-MRSA therapy

  3. Clinical outcomes of lumbar degenerative disc disease treated with posterior lumbar interbody fusion allograft spacer: a prospective, multicenter trial with 2-year follow-up.

    PubMed

    Arnold, Paul M; Robbins, Stephen; Paullus, Wayne; Faust, Stephen; Holt, Richard; McGuire, Robert

    2009-07-01

    The clinical benefits and complications of posterior lumbar interbody fusion (PLIF) have been studied over the past 60 years. In recent years, spine surgeons have had the option of treating low back pain caused by degenerative disc disease using PLIF with machined allograft spacers and posterior pedicle fixation. The purpose of this clinical series was to assess the clinical benefits of using a machined PLIF allograft spacer and posterior pedicle fixation to treat degenerative disc disease, both in terms of fusion rates and patient outcomes, and to compare these results with those in previous studies using autograft and metal interbody fusion devices. Results were also compared with results from studies using transverse process fusion. This prospective, nonrandomized clinical series was conducted at 10 US medical centers. Eighty-nine (55 male, 34 female) patients underwent PLIF with a presized, machined allograft spacer and posterior pedicle fixation between January 2000 and April 2003. Their outcomes were compared with outcomes in previous series described in the literature. All patients had experienced at least 6 months of low back pain that had been unresponsive to nonsurgical treatment. Physical examinations were performed before surgery, after surgery, and at 4 follow-up visits (6 weeks, 6 months, 12 months, 24 months). At each interval, we obtained radiographs and patient outcome measures, including SF-36 Bodily Pain Score, visual analog scale pain rating, and Oswestry Disability Index. The primary outcome was fusion results at 12 and 24 months; the secondary outcomes were pain, disability, function/quality of life, and satisfaction. One-level PLIFs were performed in 65 patients, and 2-level PLIFs in 24 patients. Flexion-extension radiographs at 12 and 24 months revealed a 98% fusion rate. Of the 72 patients who reached the 12-month follow-up, 86% reported decreased pain and disability as measured with the Oswestry Disability Index. Decreased pain as measured

  4. Does Valproic Acid or Levetiracetam Improve Survival in Glioblastoma? A Pooled Analysis of Prospective Clinical Trials in Newly Diagnosed Glioblastoma

    PubMed Central

    Happold, Caroline; Gorlia, Thierry; Chinot, Olivier; Gilbert, Mark R.; Nabors, L. Burt; Wick, Wolfgang; Pugh, Stephanie L.; Hegi, Monika; Cloughesy, Timothy; Roth, Patrick; Reardon, David A.; Perry, James R.; Mehta, Minesh P.; Stupp, Roger

    2016-01-01

    Purpose Symptomatic epilepsy is a common complication of glioblastoma and requires pharmacotherapy. Several uncontrolled retrospective case series and a post hoc analysis of the registration trial for temozolomide indicated an association between valproic acid (VPA) use and improved survival outcomes in patients with newly diagnosed glioblastoma. Patients and Methods To confirm the hypothesis suggested above, a combined analysis of survival association of antiepileptic drug use at the start of chemoradiotherapy with temozolomide was performed in the pooled patient cohort (n = 1,869) of four contemporary randomized clinical trials in newly diagnosed glioblastoma: AVAGlio (Avastin in Glioblastoma; NCT00943826), CENTRIC (Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status; NCT00689221), CORE (Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status; NCT00813943), and Radiation Therapy Oncology Group 0825 (NCT00884741). Progression-free survival (PFS) and overall survival (OS) were compared between: (1) any VPA use and no VPA use at baseline or (2) VPA use both at start of and still after chemoradiotherapy. Results of Cox regression models stratified by trial and adjusted for baseline prognostic factors were analyzed. The same analyses were performed with levetiracetam (LEV). Results VPA use at start of chemoradiotherapy was not associated with improved PFS or OS compared with all other patients pooled (PFS: hazard ratio [HR], 0.91; 95% CI, 0.77 to 1.07; P = .241; OS: HR, 0.96; 95% CI, 0.80 to 1.15; P = .633). Furthermore, PFS and OS of patients taking VPA both at start of and still after chemoradiotherapy were not different from those without antiepileptic drug use at both time points (PFS: HR, 0.92; 95% CI, 0.74 to 1.15; P = .467; OS: HR, 1.10; 95% CI, 0.86 to 1.40; P = .440). Similarly, no

  5. Species Distribution of the Mycobacterium tuberculosis Complex in Clinical Isolates from 2007 to 2010 in Turkey: a Prospective Study▿

    PubMed Central

    Bayraktar, Banu; Bulut, Emin; Barış, Ayşe Bayrı; Toksoy, Buket; Dalgıc, Nazan; Celikkan, Cigdem; Sevgi, Dilek

    2011-01-01

    The Mycobacterium tuberculosis complex (MTBC) consists of a group of closely related species that differ in their epidemiological profiles, host ranges, pathogenicities, geographic distributions, and drug resistances. Identification of members in the MTBC is essential for monitoring the epidemiology of tuberculosis (TB) and implementing appropriate public health control measures. In this study, 188 consecutive MTBC clinical isolates from 2007 to 2010 were evaluated to determine the prevalence of MTBC species in Turkey. PCR and restriction fragment length polymorphism analysis (PCR-RFLP) of the gyrB gene were used, and results for species other than M. tuberculosis were confirmed using the GenoType MTBC assay (Hain Lifescience, Nehren, Germany). Most of the strains were found to be M. tuberculosis (94.1%). The prevalences of M. bovis and M. caprae were 4.3% and 1.6%, respectively. Only one M. bovis BCG strain was identified. Overall, the frequency of bovine tuberculosis in humans was 5.3%. We had assumed that bovine TB infection was under control in animal herds, but primary M. bovis infections in humans caused by transmission from infected animals are still an issue in Turkey. Our results indicate that the frequent identification of M. bovis in routine mycobacteriological laboratory work has further importance due to the well-known resistance of this species to pyrazinamide. PMID:21940474

  6. Five- to six-year results of a prospective clinical trial using the ENDOPORE dental implant and a mandibular overdenture.

    PubMed

    Deporter, D; Watson, P; Pharoah, M; Levy, D; Todescan, R

    1999-04-01

    This report is an update on a group of 46 clinical trial patients who each received 3 free-standing Endopore dental implants placed using a 2-stage surgical approach in the anterior mandible. After an initial healing interval of 10 weeks, the implants were used in each case to retain an over-denture, and at the time of the report, all patients had passed 5 years of continuous function. The 5-year cumulative "survival" rate based on a life table analysis was 93.4% and this remained unchanged after 6 years. The 5-year "success rate" was 83.3% when assessed qualitatively with the published criteria of others using a four-field table analysis categorizing every implant in the study as one of "Grade 1 Success", "survival", "unaccounted for" or "failure". Modified periodontal parameters verified continued peri-implant soft tissue health. No implant still in function had more than 1.8 mm cumulative bone loss during the first 5 years of function. These results provide clear evidence that Endopore implants despite their short lengths function at least as well as other dental implant designs used in much longer lengths.

  7. Stereotactic Interstitial Radiosurgery With the Photon Radiosurgery System (PRS) for Metastatic Brain Tumors: A Prospective Single-Center Clinical Trial

    SciTech Connect

    Pantazis, Georgios; Trippel, Michael; Birg, Walter; Ostertag, Christoph B.; Nikkhah, Guido

    2009-12-01

    Purpose: To evaluate the efficacy and the treatment outcome of tumor patients being treated stereotactically with a miniature X-ray generator (Photon Radiosurgery System, PRS). Methods and Materials: Thirty-five patients with histologically diagnosed cerebral metastases were treated with a single fraction of stereotactic interstitial irradiation (median, 18 Gy). Clinical and neuroimaging evaluation were assessed at 2-, 6-, and 12-week intervals postoperatively and every 3 months thereafter. Survival, local control, and distant and overall brain freedom from progression were obtained using the Kaplan-Meier method. Results: Median survival was 7.37 months and the actuarial survival rates at 6 and 12 months were 60.0% and 34.3%, respectively. Acute complications on six patients were associated with shorter survival. Local tumor control at the initial stage and at the last follow-up were 82% and 50%. Eighteen patients (53%) developed distant brain metastases after treatment. At 1 year, the local control rate and distant and overall brain freedom from progression were 33.0%, 43.3%, and 14.7%, respectively. A shorter local tumor control was observed by PRS treatment of a recurrent tumor and by irregular tumor configuration. Conclusions: Interstitial radiosurgery with the PRS requires continued investigation. It allows for an immediate and potentially cost-efficient treatment for patients with singular, small (<= 6.36 cm{sup 3}; or <= 2.3 cm) spherical brain metastasis subsequent to a stereotactic biopsy.

  8. The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients with Severe Sepsis: A Prospective Cohort Study.

    PubMed

    Shang, Xiuling; Wang, Kaiyu; Xu, Jingqing; Gong, Shurong; Ye, Yong; Chen, Kaihua; Lian, Fayang; Chen, Wei; Yu, Rongguo

    2016-01-01

    Purpose. This study was aimed at investigating the effect of esmolol on tissue perfusion and the clinical prognosis of patients with severe sepsis. Materials and Methods. One hundred fifty-one patients with severe sepsis were selected and divided into the esmolol group (n = 75) or the control group (n = 76), who received conventional antiseptic shock treatment. The esmolol group received a continuous infusion of esmolol via a central venous catheter, and their heart rate (HR) was maintained at 70-100 bpm over 72 hours. Results. The HR of all patients reached the target level within 72 hours of treatment for both groups. The effect of esmolol on PvaCO2 was only significant at 48 hours (P < 0.05). ScvO2 increased in the esmolol group and decreased in the control group (P < 0.01). Lac showed a linear downward trend over the treatment time, but the reduction was more significant in the control group at 48 hours (P < 0.05) between the two groups. Kaplan-Meier analysis showed a significantly shorter duration of mechanical ventilation in the esmolol group than in the control group (P < 0.05). Conclusions. Esmolol reduced the duration of mechanical ventilation in patients with severe sepsis, with no significant effect on circulatory function or tissue perfusion. PMID:27652257

  9. The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients with Severe Sepsis: A Prospective Cohort Study

    PubMed Central

    Wang, Kaiyu; Xu, Jingqing; Gong, Shurong; Ye, Yong; Chen, Kaihua; Chen, Wei

    2016-01-01

    Purpose. This study was aimed at investigating the effect of esmolol on tissue perfusion and the clinical prognosis of patients with severe sepsis. Materials and Methods. One hundred fifty-one patients with severe sepsis were selected and divided into the esmolol group (n = 75) or the control group (n = 76), who received conventional antiseptic shock treatment. The esmolol group received a continuous infusion of esmolol via a central venous catheter, and their heart rate (HR) was maintained at 70–100 bpm over 72 hours. Results. The HR of all patients reached the target level within 72 hours of treatment for both groups. The effect of esmolol on PvaCO2 was only significant at 48 hours (P < 0.05). ScvO2 increased in the esmolol group and decreased in the control group (P < 0.01). Lac showed a linear downward trend over the treatment time, but the reduction was more significant in the control group at 48 hours (P < 0.05) between the two groups. Kaplan-Meier analysis showed a significantly shorter duration of mechanical ventilation in the esmolol group than in the control group (P < 0.05). Conclusions. Esmolol reduced the duration of mechanical ventilation in patients with severe sepsis, with no significant effect on circulatory function or tissue perfusion. PMID:27652257

  10. Risk factors for failure of glass fiber-reinforced composite post restorations: a prospective observational clinical study.

    PubMed

    Naumann, Michael; Blankenstein, Felix; Kiessling, Saskia; Dietrich, Thomas

    2005-12-01

    Glass fiber-reinforced endodontic posts are considered to have favorable mechanical properties for the reconstruction of endodontically treated teeth. The aim of the present investigation was to evaluate the survival of two tapered and one parallel-sided glass fiber-reinforced endodontic post systems in teeth with different stages of hard tissue loss and to identify risk factors for restoration failure. One-hundred and forty-nine glass fiber-reinforced endodontic posts in 122 patients were followed-up for 5-56 months [mean +/- standard deviation (SD): 39 +/- 11 months]. Glass fiber-reinforced endodontic posts were adhesively luted and the core was built with a composite resin. Cox proportional hazards models were used to evaluate the association of clinical variables and failure rate. Higher failure rates were found for restorations of anterior teeth compared with posterior teeth [Hazard-Ratios (HR): 3.1; 95% confidence interval (CI): 1.3-7.4], for restorations in teeth with no proximal contacts compared with at least one proximal contact (HR: 3.0; 95% CI: 1.0-9.0), and for teeth restored with single crowns compared with fixed bridges (HR: 4.3; 95% CI: 1.1-16.2). Tooth type, type of final restoration and the presence of adjacent teeth were found to be significant predictors of failure rates in endodontically treated teeth restored with glass fiber-reinforced endodontic posts. PMID:16324143

  11. Technetium-99m red blood cell venography in patients with clinically suspected deep vein thrombosis: a prospective study

    SciTech Connect

    Leclerc, J.R.; Wolfson, C.; Arzoumanian, A.; Blake, G.P.; Rosenthall, L.

    1988-09-01

    We have compared technetium-99m (99mTc) red blood cell (RBC) venography to serial impedance plethysmography (IPG) in 110 consecutive patients with a first episode of clinically suspected deep vein thrombosis (DVT). IPG was performed at Day 0 and, if abnormal, contrast venography was also performed to rule out a falsely positive result. Patients with an initially normal IPG had the test repeated at Days 1, 3, 5 to 7, and 10 to 14. Contrast venography was not performed and anticoagulant treatment was withheld in all patients who remained normal during repeated IPG testing. Technetium-99m RBC venography was performed at Day 0 in patients with an initially abnormal IPG and during the period of serial IPG testing in those with an initially normal IPG. The sensitivity of (99mTc)RBC venography for proximal DVT was 0.68, with 95% confidence limits (CL) from 0.48 to 0.89. Specificity was 0.88 (95% CL from 0.81 to 0.95). When the findings of (99mTc)RBC venography for the entire lower extremity were compared to the reference method, the sensitivity increased to 0.90 (95% CL from 0.82 to 0.97) but the specificity decreased to 0.56 (95% CL from 0.51 to 0.62). Technetium-99m RBC venography is a sensitive but less specific method for detecting DVT of the entire lower extremity. An abnormal (99mTc)RBC venogram, particularly in the calf region, should always be confirmed by another diagnostic method.

  12. Effects of nutritional intervention in head and neck cancer patients undergoing radiotherapy: A prospective randomized clinical trial

    PubMed Central

    Kang, Wen-Xing; Li, Wentao; Huang, Shi-Gao; Dang, Yazhang; Gao, Hongxiang

    2016-01-01

    Head and neck malignant tumors have numerous locations of the disease. After patients receive radiotherapy, their nutritional status is very poor, thus the curative effect is unsatisfactory. The aims of the present study were to investigate and analyze the nutritional status of patients with head and neck cancer undergoing radiotherapy (RT) in order to provide positive nutrition intervention for assisting the radiotherapy effect. A total of 40 patients with head and neck cancer were selected using a method of subjective global assessment (SGA) to assess nutritional status, including calorie intake and energy expenditure. In a randomized, controlled study, 20 patients received intensive dietary counseling and nutritional therapy (G1) and 20 received regular dietary as controls (G0) preradiotherapy and postradiotherapy. The primary endpoint was calorie intake and energy expenditure. The secondary endpoint was SGA rating with nutritional therapy. At the end of RT, energy intake showed a net increase in G1 (1,691±301 kcal) compared with that in G0 (1,066±312 kcal) (P<0.05); energy expenditure increased in G1 (1,673±279 kcal) compared with G0 (1,490±298 kcal) (P<0.05). The prevalence of severe malnutrition following radiotherapy was significantly different between the two study groups (10 patients in G0 and 4 patients in G1; P<0.05). The number of the normal malnutrition patients postRT in G0 decreased from 4 to 2 and conversely, in G1 it increased from 3 to 6 (P<0.05). In conclusion, patients with head and neck cancer were most malnutritioned, which impacted on clinical outcome. Timely nutritional intervention can effectively prevent weight loss and muscle wasting. Additionally, it may improve quality of life by decreasing the frequency of severe malnutrition. PMID:27588193

  13. A prospective, longitudinal, descriptive study of the effect of a customized wheelchair cushion on clinical variables, satisfaction, and functionality among patients with spinal cord injury.

    PubMed

    Vilchis-Aranguren, Rodrigo; Gayol-Mérida, Diana; Quinzaños-Fresnedo, Jimena; Pérez-Zavala, Ramiro; Galíndez-Novoa, Carmen

    2015-02-01

    The Instituto Nacional de Rehabilitación (Rehabilitation National Institute) (INR) developed a prototype wheelchair cushion (INR cushion) designed to adjust to the anthropometry of the user's ischiogluteal area and prevent pressure ulcer formation while maintaining or promoting functionality. A prospective, longitudinal, descriptive study was conducted from February 2010 to February 2011 to evaluate the effect of using the INR cushion on clinical variables, functionality, and user satisfaction. Sixteen patients were recruited (9 male, 7 female, average age 31.8 [range 22-47] years, average body mass index 25 [range 22-34], average time in a wheelchair 10.1 [range 3-26] years) who met the study protocol inclusion criteria of being pressure ulcer-free for at least 6 months and capable of propulsion and transfer without assistance, chronic spinal cord injury (>2 years), and without chronic-degenerative diseases or cognitive problems. Each participant received the cushion for a 2-month evaluation. Eight clinical variables were assessed: trunk control, posture, spasticity, transfer capacity, comfort, skin reaction, propulsion capacity, and pressure release capacity. The clinical assessment was performed using validated scales and instruments: Modified Ashworth Scale (MAS), Functional Independence Measure™ (FIM), Norton Scale, and assessment of skin reaction. Interface pressures were measured using force sensing array, and participants completed a structured interview to assess user expectation, perceived functionality, perceived quality, and likelihood of recommending the device. Two patients withdrew due to appointment conflicts; of the remaining 14, significant differences between the user's experience with other products and the INR were found with regard to pressure redistribution (P = 0.012); all participants but 1 graded the INR as good in all interview categories. No participants developed a pressure ulcer during the study. The customized cushion was

  14. Gender difference in symptomatic radiographic knee osteoarthritis in the Knee Clinical Assessment – CAS(K): A prospective study in the general population

    PubMed Central

    Lacey, Rosie J; Thomas, Elaine; Duncan, Rachel C; Peat, George

    2008-01-01

    Background A recent study of adults aged ≥50 years reporting knee pain found an excess of radiographic knee osteoarthritis (knee ROA) in symptomatic males compared to females. This was independent of age, BMI and other clinical signs and symptoms. Since this finding contradicts many previous studies, our objective was to explore four possible explanations for this gender difference: X-ray views, selection, occupation and non-articular conditions. Methods A community-based prospective study. 819 adults aged ≥50 years reporting knee pain in the previous 12 months were recruited by postal questionnaires to a research clinic involving plain radiography (weight-bearing posteroanterior semiflexed, supine skyline and lateral views), clinical interview and physical examination. Any knee ROA, ROA severity, tibiofemoral joint osteoarthritis (TJOA) and patellofemoral joint osteoarthritis (PJOA) were defined using all three radiographic views. Occupational class was derived from current or last job title. Proportions of each gender with symptomatic knee ROA were expressed as percentages, stratified by age; differences between genders were expressed as percentage differences with 95% confidence intervals. Results 745 symptomatic participants were eligible and had complete X-ray data. Males had a higher occurrence (77%) of any knee ROA than females (61%). In 50–64 year olds, the excess in men was mild knee OA (particularly PJOA); in ≥65 year olds, the excess was both mild and moderate/severe knee OA (particularly combined TJOA/PJOA). This male excess persisted when using the posteroanterior view only (64% vs. 52%). The lowest level of participation in the clinic was symptomatic females aged 65+. Within each occupational class there were more males with symptomatic knee ROA than females. In those aged 50–64 years, non-articular conditions were equally common in both genders although, in those aged 65+, they occurred more frequently in symptomatic females (41%) than

  15. Crinone Gel for Luteal Phase Support in Frozen-Thawed Embryo Transfer Cycles: A Prospective Randomized Clinical Trial in the Chinese Population

    PubMed Central

    Zhao, Xiaoming; Ji, Xiaowei; Hong, Yan; Wang, Yuan; Zhu, Qinling; Xu, Bin; Sun, Yun

    2015-01-01

    To compare Crinone vaginal progesterone gel with intramuscularly injected progesterone for luteal phase support in progesterone-supplemented frozen-thawed embryo transfer (FET) cycles, a randomized prospective study of patients qualified for FET was conducted between September 2010 and January 2013 at a hospital in Shanghai, China. From the day of transformation into secretory phase endometrium (day 0), Crinone vaginal gel (90 mg/d) was administered to patients in the Gel Group, while progesterone (40 mg/d) was injected intramuscularly in patients in the Inj Group (n = 750 per group). All patients received oral dydrogesterone (20 mg/d) and estradiol valerate (4–8 mg/d). Day 3 embryos with the highest pre-frozen scores were transferred to patients in the two groups and the clinical outcomes compared. This study comprised 1,500 cycles (750 in each group). Twenty-nine cycles in the Gel Group and 24 in the Inj Group were withdrawn. There were no significant differences between groups in age, endometrial thickness, endometrial preparation time or number of embryos transferred. No significant differences were observed between the Gel Group and Inj Group in the rates of live birth (32.6% vs. 31.7%, P = 0.71), clinical pregnancy (40.1% vs. 40.6%, P = 0.831), implantation (25.8% vs. 25.3%, P = 0.772), abortion (16.3% vs. 18.3%, P = 0.514) or ectopic pregnancy (2.8% vs. 4.4%, P = 0.288). Multivariate logistic regression analysis revealed that the odds ratios (95% confidence intervals) for the rates of live birth, clinical pregnancy, abortion and ectopic pregnancy (Gel Group relative to Inj Group) were 1.036 (0.829–1.295), 0.971 (0.785–1.200), 0.919 (0.595–1.420) and 0.649 (0.261–1.614), respectively. Our study revealed that using Crinone vaginal gel in FET cycles achieved similar pregnancy outcomes to intramuscular progesterone, indicating that vaginal gel is a viable alternative to intramuscular injection. Trial Registration Chinese Clinical Trial Registry Chi

  16. A dynamic clinical pathway for the treatment of patients with early breast cancer is a tool for better cancer care: implementation and prospective analysis between 2002–2010

    PubMed Central

    2013-01-01

    Background Due to increasing the complexity of breast cancer treatment it is of paramount importance to develop structured care in order to avoid a chaotic and non-consistent management of patients. Clinical pathways, a result of the adaptation of the documents used in industrial quality management namely the Standard Operating Procedures, can be used to improve efficiency and quality of care. They also aim to re-centre the focus on the patient’s overall journey, rather than the contribution of each specialty or caring function independently. Methods The effect of the implementation and prospective systematic evaluation of a clinical care pathway for the management of patients with early breast cancer in a single breast unit is evaluated over a long time interval (between 2002 and 2010). Annual analysis of predefined clinical outcome measures, service indicators, team indicators, process indicators and financial indicators was performed. Pathway quality control meetings were organized at least once a year. Systematic feedback was given to the team members, and if necessary the pathway was adapted according to evidence based literature data and in house pathway related data in order to improve quality. Results The annual number of patients included in the pathway (289 vs. 390, P <0.01), proportion of patients with Tis-T1 tumors (42% vs. 58%, P <0.01), negative lymph nodes (44% vs. 58%, P <0.01) and no metastases at diagnosis (91.5% vs. 95.9%) has risen significantly between 2002 and 2010. Evolution of mandatory quality indicators defined by EUSOMA shows a significant improvement of quality of cancer care. Particularly, the proportion of patients having anti-hormonal therapy (84.8% vs. 97.4%, P = 0.002) and adjuvant chemotherapy according to the guidelines (72% vs. 95.6%, P = 0.028) increased dramatically. Patient satisfaction improved significantly (P <0.05). Progression free 4-year survival was significantly higher for all patients, for T1 tumors only and for T2

  17. Pharmacokinetics and safety of a novel recombinant human von Willebrand factor manufactured with a plasma-free method: a prospective clinical trial

    PubMed Central

    Mannucci, Pier Mannuccio; Kempton, Christine; Millar, Carolyn; Romond, Edward; Shapiro, Amy; Birschmann, Ingvild; Ragni, Margaret V.; Gill, Joan Cox; Yee, Thynn Thynn; Klamroth, Robert; Wong, Wing-Yen; Chapman, Miranda; Engl, Werner; Turecek, Peter L.; Suiter, Tobias M.

    2013-01-01

    Safety and pharmacokinetics (PK) of recombinant von Willebrand factor (rVWF) combined at a fixed ratio with recombinant factor VIII (rFVIII) were investigated in 32 subjects with type 3 or severe type 1 von Willebrand disease (VWD) in a prospective phase 1, multicenter, randomized clinical trial. rVWF was well tolerated and no thrombotic events, inhibitors, or serious adverse events were observed. The PK of rVWF ristocetin cofactor activity, VWF antigen, and collagen-binding activity were similar to those of the comparator plasma-derived (pd) VWF-pdFVIII. In vivo cleavage of ultra-large molecular-weight rVWF multimers by ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13; the endogenous VWF protease) and generation of characteristic satellite bands were demonstrated. In 2 subjects with specific nonneutralizing anti-VWF–binding antibodies already detectable before rVWF infusion, a reduction in VWF multimers and VWF activity was observed. Stabilization of endogenous FVIII was enhanced following post–rVWF-rFVIII infusion as shown by the difference in area under the plasma concentration curve compared with pdVWF-pdFVIII (AUC0-∞) (P < .01). These data support the concept of administering rVWF alone once a therapeutic level of endogenous FVIII is achieved. This trial was registered at www.clinicaltrials.gov as #NCT00816660. PMID:23777763

  18. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    PubMed Central

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Hervé; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Krüger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (−5.4 ± 6.3°; p < 0.001), remained at 12 months (−4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery. PMID:26844224

  19. Two-Dimensional Cutting (TDC) Vitrectome: In Vitro Flow Assessment and Prospective Clinical Study Evaluating Core Vitrectomy Efficiency versus Standard Vitrectome

    PubMed Central

    2016-01-01

    Purpose. To evaluate comparative aspiration flow performance and also vitrectomy operating time efficiency using a double-cutting open port vitreous cutting system incorporated in a two-dimensional cutting (TDC, DORC International) vitrectome design versus standard vitreous cutter. Methods. In vitro investigations compared aspiration flow rates in artificial vitreous humor at varying cutter speeds and vacuum levels using a TDC vitrectome and a standard vitrectome across different aspiration pump systems. A prospective single-centre clinical study evaluated duration of core vitrectomy in 80 patients with macular pucker undergoing 25-gauge or 27-gauge vitrectomy using either a TDC vitrectome at 16,000 cuts per minute (cpm) or standard single-cut vitrectome, combined with a Valve Timing intelligence (VTi) pump system (EVA, DORC International). Results. Aspiration flow rates remained constant independent of TDC vitrectome cut rate, while flow rates decreased linearly at higher cutter speeds using a classic single-blade vitrectome. Mean duration of core vitrectomy surgeries using a TDC vitreous cutter system was significantly (p < 0.001) shorter than the mean duration of core vitrectomy procedures using a single-cut vitrectome of the same diameter (reduction range, 34%–50%). Conclusion. Vitrectomy surgery performed using a TDC vitrectome was faster than core vitrectomy utilizing a standard single-action vitrectome at similar cut speeds. PMID:27190635

  20. Prospective randomized clinical trial comparing hemiarthroplasty to total hip arthroplasty in the treatment of displaced femoral neck fractures: winner of the Dorr Award.

    PubMed

    Macaulay, William; Nellans, Kate W; Garvin, Kevin L; Iorio, Richard; Healy, William L; Rosenwasser, Melvin P

    2008-09-01

    The Displaced Femoral (neck fracture) Arthroplasty Consortium for Treatment and Outcomes study is a prospective, multicenter randomized clinical trial comparing hemiarthroplasty to total hip arthroplasty (THA) in the treatment of displaced femoral neck fractures in previously independent patients. Primary outcomes were measured at 6, 12, and 24 months with the Short Form-36 (SF-36), Western Ontario and McMaster Osteoarthritis Index (WOMAC), and the Harris Hip Score and the Timed "Up & Go" Test. Forty subjects were enrolled. At 24 months, THA patients had significantly less pain on the SF-36 subscale than hemiarthroplasty patients (54.8 +/- 7.9 vs 44.7 +/- 10.5, P = .04) and scored significantly better on the SF-36 mental health subscale (54.9 +/- 9.4 vs 40.9 +/- 10.3, P = .006). Total hip arthroplasty patients also had superior WOMAC function scores (81.8 +/- 10.2 vs 65.1 +/- 18.1, P = .03). Significant differences in outcomes, without a significantly greater incidence of complications, suggest THA is a valuable treatment option for the active elderly hip fracture population.

  1. Effects of 8 weeks of military training on lower extremity and lower back clinical findings of young Iranian male recruits: A prospective case series

    PubMed Central

    Boroujeni, Amir Momeni; Yousefi, Elham; Moayednia, Amir; Tahririan, Mohammad Ali

    2014-01-01

    Background: In this prospective case series we have assessed the clinical effects of 8 weeks military training on the lower extremity of the recruits. Materials and Methods: Military recruits who met the eligibility criteria and gave informed consent were entered into the study. They were asked to fill out a self-reporting pain and functionality questionnaire before and after their training. They were also examined by a physician before and after their military training. The questionnaire and examination were concentrated on three blocs: lower back, knee, and foot. Results: Three-hundred and seventy-three study subjects were evaluated. The study showed that there is a significant difference in reporting lower back pain after the training compared to the rate of complaints prior to the training (P < 0.001), knee pain, and foot pain also increased significantly (P < 0.1 and P < 0.0001, respectively) The difference was most prominent in foot complaints. Physical examination also showed significant increase in lower extremity findings following the training (P < 0.05). Conclusion: Our study shows that there is a need for a new approach to military training of male recruits in Iran in order to minimize the adverse health effects. PMID:24600600

  2. Effects of Aloe vera cream on chronic anal fissure pain, wound healing and hemorrhaging upon defection: a prospective double blind clinical trial.

    PubMed

    Rahmani, N; Khademloo, M; Vosoughi, K; Assadpour, S

    2014-01-01

    Aloe vera is a medicinal plant that promotes wound healing in burn injuries. A prospective clinical trial was conducted to evaluate the effects of a topical cream containing 0.5% Aloe vera juice powder in the treatment of chronic anal fissures. The aloe cream was applied by the patients to the wound site 3 times per day for 6 weeks following the instructions of a physician. Pain was assessed with a visual analog scale before treatment and at the end of each week of treatment. Wound healing and the amount and severity of bleeding were examined and evaluated before and at the end of each week of treatment. There were statistically significant differences in chronic anal fissure pain, hemorrhaging upon defection and wound healing before and at the end of the first week of treatment also in comparison with control group (p < 0.0001). In this study, a topical cream containing aloe vera juice was an effective treatment for chronic anal fissures. This is a promising result indicating that further comparative studies are justified.

  3. Induction Therapy with Bortezomib Followed by Bortezomib-High Dose Melphalan and Stem Cell Transplantation for Light Chain Amyloidosis: Results of a Prospective Clinical Trial.

    PubMed

    Sanchorawala, Vaishali; Brauneis, Dina; Shelton, Anthony C; Lo, Stephen; Sun, Fangui; Sloan, J Mark; Quillen, Karen; Seldin, David C

    2015-08-01

    The depth of hematologic response has been shown to correlate with survival and organ responses for patients with light chain (AL) amyloidosis. We conducted a prospective trial of 2 cycles of induction with bortezomib and dexamethasone on a twice a week schedule followed by conditioning with bortezomib and high-dose melphalan (HDM) and autologous stem cell transplantation (SCT). The objectives were hematologic responses, tolerability, and survival. Thirty-five patients were enrolled from 2010 to 2013. Of these, 30 proceeded with SCT, whereas 5 did not because of clinical deterioration during induction (n = 3) or complications after stem cell collection (n = 2). Two patients developed features of an autologous graft-versus-host disease-like syndrome post-SCT, which responded to steroids; no other unusual complications were seen. Treatment-related mortality occurred in 8.5% (3/35). Hematologic responses were achieved by 100% of the 27 assessable patients (63% complete response, 37% very good partial response [VGPR]) who completed the planned treatment. By intention-to-treat, hematologic responses occurred in 77% of patients (49% complete response, 29% VGPR). With a median follow-up of 36 months, the median overall survival and progression-free survival were not reached. In conclusion, incorporating bortezomib into induction and conditioning yielded a high rate of hematologic responses after HDM/SCT in patients with AL amyloidosis.

  4. Analgesia after feline ovariohysterectomy under midazolam-medetomidine-ketamine anaesthesia with buprenorphine or butorphanol, and carprofen or meloxicam: a prospective, randomised clinical trial.

    PubMed

    Polson, Sally; Taylor, Polly M; Yates, David

    2012-08-01

    One hundred female cats undergoing routine ovariohysterectomy under midazolam-medetomidine-ketamine anaesthesia were included in a blinded, randomised, prospective clinical study to compare postoperative analgesia produced by four analgesic drug combinations given preoperatively (n = 25 per group). A secondary aim was to assess the effects in kittens and pregnant animals. Buprenorphine 180 µg/m(2) or butorphanol 6 mg/m(2) were given with either carprofen 4 mg/kg (groups BUPC and BUTC, respectively) or meloxicam 0.3 mg/kg (groups BUPM or BUTM, respectively). Medetomidine was not antagonised. A simple, descriptive scale (SDS; 0-4), a dynamic and interactive visual analogue scale (DIVAS; 0-100 mm) and mechanical nociceptive thresholds (MT; 2.5-mm diameter probe) were used to evaluate postoperative pain. All pain scores were low (DIVAS <10 mm, SDS <2 and MT >10 N) and there were no significant differences between the groups. It was concluded that all protocols provided adequate analgesia and when used with midazolam-medetomidine-ketamine are effective for routine feline ovariohysterectomy. PMID:22505603

  5. A Prospective Pathologic Study to Define the Clinical Target Volume for Partial Breast Radiation Therapy in Women With Early Breast Cancer

    SciTech Connect

    Nguyen, Brandon T.; Deb, Siddhartha; Fox, Stephen; Hill, Prudence; Collins, Marnie; Chua, Boon H.

    2012-12-01

    Purpose: To determine an appropriate clinical target volume for partial breast radiation therapy (PBRT) based on the spatial distribution of residual invasive and in situ carcinoma after wide local excision (WLE) for early breast cancer or ductal carcinoma in situ (DCIS). Methods and Materials: We performed a prospective pathologic study of women potentially eligible for PBRT who had re-excision and/or completion mastectomy after WLE for early breast cancer or DCIS. A pathologic assessment protocol was used to determine the maximum radial extension (MRE) of residual carcinoma from the margin of the initial surgical cavity. Women were stratified by the closest initial radial margin width: negative (>1 mm), close (>0 mm and {<=}1 mm), or involved. Results: The study population was composed of 133 women with a median age of 59 years (range, 27-82 years) and the following stage groups: 0 (13.5%), I (40.6%), II (38.3%), and III (7.5%). The histologic subtypes of the primary tumor were invasive ductal carcinoma (74.4%), invasive lobular carcinoma (12.0%), and DCIS alone (13.5%). Residual carcinoma was present in the re-excision and completion mastectomy specimens in 55.4%, 14.3%, and 7.2% of women with an involved, close, and negative margin, respectively. In the 77 women with a noninvolved radial margin, the MRE of residual disease, if present, was {<=}10 mm in 97.4% (95% confidence interval 91.6-99.5) of cases. Larger MRE measurements were significantly associated with an involved margin (P<.001), tumor size >30 mm (P=.03), premenopausal status (P=.03), and negative progesterone receptor status (P=.05). Conclusions: A clinical target volume margin of 10 mm would encompass microscopic residual disease in >90% of women potentially eligible for PBRT after WLE with noninvolved resection margins.

  6. Body mass index is not a clinically meaningful predictor of patient reported outcomes of primary hip replacement surgery: prospective cohort study

    PubMed Central

    Judge, Andy; Batra, Rajbir N; Thomas, Geraint; Beard, David; Javaid, M Kassim; Murray, David; Dieppe, Paul A; Dreinhoefer, Karsten; Peter-Guenther, Klaus; Field, Richard; Cooper, Cyrus; Arden, Nigel K

    2014-01-01

    Objectives To describe whether body mass index (BMI) is a clinically meaningful predictor of patient reported outcomes following primary total hip replacement (THR) surgery Design Combined data from prospective cohort studies. We obtained information from four cohorts of patients receiving primary THR for osteoarthritis: Exeter Primary Outcomes Study (n=1431); EUROHIP (n=1327); Elective Orthopaedic Centre (n=2832); and St. Helier (n=787). The exposure of interest was pre-operative BMI. Confounding variables included: age, sex, SF-36 mental health, comorbidities, fixed flexion, analgesic use, college education, OA in other joints, expectation of less pain, radiographic K&L grade, ASA grade, years of hip pain. The primary outcome was the Oxford Hip Score (OHS). Regression models describe the association of BMI on outcome adjusting for all confounders. Results For a 5-unit increase in BMI, the attained 12-month OHS decreases by 0.78 points 95%CI (0.27 to 1.28), p-value 0.001. Compared to people of normal BMI (20 to 25), those in the obese class II (BMI 35 to 40) would have a 12-month OHS that is 2.34 points lower. Although statistically significant this effect is small and not clinically meaningful in contrast to the substantial change in OHS seen across all BMI groupings. In obese class II patients achieved a 22.2 point change in OHS following surgery. Conclusions Patients achieved substantial change in OHS after THR across all BMI categories, which greatly outweighs the small difference in attained post-operative score. The findings suggest BMI should not present a barrier to access THR in terms of PROMs. PMID:24418679

  7. Quality of Life and Associated Socio-Clinical Factors after Encephalitis in Children and Adults in England: A Population-Based, Prospective Cohort Study

    PubMed Central

    Ramanuj, Parashar Pravin; Granerød, Julia; Davies, Nicholas W. S.; Conti, Stefano; Brown, David W. G.; Crowcroft, Natasha S.

    2014-01-01

    Objective We sought to measure HRQoL in all-cause encephalitis survivors and assess the impact of various socio-clinical factors on outcome. Methods We used a prospective cohort study design, using the short-form 36 (SF-36) to measure the HRQoL in patients 15 years and older, and the short-form 10 (SF-10) for patients less than 15 years old. We posted questionnaires to individuals six months after discharge from hospital. All scores were normalised to the age- and sex-matched general population. We used multivariate statistical analysis to assess the relative association of clinical and socio-demographic variables on HRQoL in adults. Results Of 109 individuals followed-up, we received 61 SF-36 and twenty SF-10 questionnaires (response rate 74%). Patients scored consistently worse than the general population in all domains of the SF-36 and SF-10, although there was variation in individual scores. Infectious encephalitis was associated with the worst HRQoL in those aged 15 years and over, scoring on average 5.64 points less than immune-mediated encephalitis (95% CI −8.77– −2.89). In those aged less than 15 years the worst quality of life followed encephalitis of unknown cause. Immuno compromise, unemployment, and the 35–44 age group all had an independent negative association with HRQoL. A poor Glasgow Outcome Score was most strongly associated with a poor HRQoL. Less than half of those who had made a ‘good’ recovery on the score reported a HRQoL equivalent to the general population. Conclusions Encephalitis has adverse effects on the majority of survivors’ wellbeing and quality of life. Many of these adverse consequences could be minimised by prompt identification and treatment, and with better rehabilitation and support for survivors. PMID:25072738

  8. Prospective Study on the Incidence and Progression of Clinical Signs in Naïve Dogs Naturally Infected by Leishmania infantum

    PubMed Central

    Foglia Manzillo, Valentina; Di Muccio, Trentina; Cappiello, Sivia; Scalone, Aldo; Paparcone, Rosa; Fiorentino, Eleonora; Gizzarelli, Manuela; Gramiccia, Marina; Gradoni, Luigi; Oliva, Gaetano

    2013-01-01

    The incidence of clinical and clinicopathological signs associated with the progression of infection was evaluated prospectively in 329 naïve young dogs exposed to Leishmania infantum transmission and examined periodically during 22 months (M). The dogs were part of Leishmania vaccine investigations performed under natural conditions. Vaccinated groups were considered in the evaluation when the vaccine resulted non-protective and the appearance and progression of signs did not differ statistically from controls at each time point, otherwise only control groups were included. 115 beagles were part of 3 studies (A to C) performed in the same kennel; 214 owned dogs (29 breeds, 2.3% beagles) were included in a study (D) performed in 45 endemic sites. At M22 the prevalence of any Leishmania infection stage classified as subpatent, active asymptomatic, or symptomatic was 59.8% in studies A–C and 29.2% in study D. Despite different breed composition and infection incidence, the relative proportion of active infections and the progression and type of clinical and clinicopathological signs have been similar in both study sets. All asymptomatic active infections recorded have invariably progressed to full-blown disease, resulting in 56 sick dogs at M22. In these dogs, lymph nodes enlargement and weight loss — recorded from M12 — were the most common signs. Cutaneous signs were seen late (M18) and less frequently. Ocular signs appeared even later, being sporadically recorded at M22. Most clinicopathological alterations became evident from M12, although a few cases of thrombocytopenia or mild non-regenerative anemia were already observed at M6. Albumin/globulin inversions were recorded from M12 and urea/creatinine increase appeared mostly from M18. Altogether our findings indicate that any susceptible young dogs naturally infected by L. infantum present a common pattern of progression of signs during 2 years post infection, providing clues for medical and

  9. Benefits of maltodextrin intake 2 hours before cholecystectomy by laparotomy in respiratory function and functional capacity: a prospective randomized clinical trial

    PubMed Central

    Zani, Fabiana Vieira Breijão; Aguilar-Nascimento, José Eduardo; Nascimento, Diana Borges Dock; da Silva, Ageo Mário Cândido; Caporossi, Fernanda Stephan; Caporossi, Cervantes

    2015-01-01

    ABSTRACT Objective: To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting. Methods: Randomized prospective clinical trial, with 92 female patients undergoing cholecystectomy by laparotomy with conventional or 2 hours shortened fasting. The variables measured were the peak expiratory flow, forced expiratory volume in the first second, forced vital capacity, dominant handgrip strength, and non-dominant handgrip strength. Evaluations were performed 2 hours before induction of anesthesia and 24 hours after the operation. Results: The two groups were similar in preoperative evaluations regarding demographic and clinical characteristics, as well as for all variables. However, postoperatively the group with shortened fasting had higher values than the group with conventional fasting for lung function tests peak expiratory flow (128.7±62.5 versus 115.7±59.9; p=0.040), forced expiratory volume in the first second (1.5±0.6 versus 1.2±0.5; p=0.040), forced vital capacity (2.3±1.1 versus 1.8±0.9; p=0.021), and for muscle function tests dominant handgrip strength (24.9±6.8 versus 18.4±7.7; p=0.001) and non-dominant handgrip strength (22.9±6.3 versus 17.0±7.8; p=0.0002). In the intragroup evaluation, there was a decrease in preoperative compared with postoperative values, except for dominant handgrip strength (25.2±6.7 versus 24.9±6.8; p=0.692), in the shortened fasting group. Conclusion: Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant handgrip strength. PMID:26154547

  10. The reliability and validity of color indicators using digital image analysis of peristomal skin photographs: results of a preliminary prospective clinical study.

    PubMed

    Iizaka, Shinji; Asada, Mayumi; Koyanagi, Hiroe; Sasaki, Sanae; Naito, Ayumi; Konya, Chizuko; Sanada, Hiromi

    2014-03-01

    Accurate assessment is necessary to evaluate peristomal skin condition, but objective methods are lacking. The purpose of this prospective, repeated-measures study was to evaluate the reliability and validity of color indicators using digital image analysis of peristomal skin photographs. The 6-month study was conducted among 21 patients (mean age 65.1 years old, 15 men) with ostomies (14 colostomies, six ileostomies, and one urostomy) at four outpatient clinics. Photographs taken by nurses of the peristomal area using point-and-shoot cameras were processed using digital image analysis, which involved color calibration, image processing, and indicator calculation. An erythema index (EI), melanin index (MI), and hypopigmentation index were created to represent increased degrees of red, black, and white color, respectively, and their average values in the peristomal region of an image were calculated relative to values for intact skin. Reproducibility was evaluated using the interclass correlation coefficient (ICC). ICCs of color indicators for intact skin were >0.7 between baseline and the end of follow-up for the 16 participants with two or more clinic visits. Differences in these indices between peristomal and intact regions were evaluated using a linear mixed model. The EI and MI of peristomal skin were significantly higher than those of intact skin (n=42, P<0.001). All color indicators in adjacent regions and areas where adhesive was applied were associated with the discoloration severity score and visual analogue pain score (all P<0.05). This objective and simple method had adequate reproducibility and criterion-related validity and may be useful for peristomal skin assessment. Further research is warranted. PMID:24610557

  11. Comparison of Metformin and Simvastatin Administration in Women With Polycystic Ovary Syndrome Before Intra-Cytoplasmic Sperm Injection Cycle: A Prospective, Randomized, Clinical Trial Study

    PubMed Central

    Pourmatroud, Elham; Mohammadjafari, Razieh; Roozitalab, Mandana

    2015-01-01

    Background: Drugs administration as a pretreatment regiment before ICSI cycle in PCOs patients could enhance the success rate. Objectives: The aim of this study was to compare the effectiveness of metformin with Simvastatin in patients with polycystic ovary syndrome (PCOs) candidates for intra-cytoplasmic sperm injection (ICSI) before starting the cycle. Patients and Methods: In this prospective, double blind, randomized clinical trial the efficacy of these drugs was evaluated in 40 women with PCO syndrome (20 patients in each group; A: simvastatin and B: metformin) candidates for ICSI. In the both groups, metformin and simvastatin administrated for eight weeks before starting the ICSI cycle. Endocrine, metabolic and clinical parameters were measured before and after drug therapy; also, the results of ICSI cycle evaluated in the both groups. Results: Both drugs improved hirsutism score significantly, but simvastatin better than metformin (Group A, 24.5 ± 3.6 P: 0.0001 VS Group B, 22.9 ± 5.9 P: 0.003). The reduction in body mass index (BMI) was not significant in the groups. Simvastatin reduced some biochemical parameters such as FSH, LH, testosterone, total cholesterol, LDL and increased HDL level significantly, whereas metformin decreased FSH, TG, testosterone and total cholesterol significantly. Overall, respectively 35% and 30% of patients treated with metformin and Simvastatin became pregnant. There was no significant difference between the effects of these two drugs on ICSI cycle results like oocyte in meiosis2 (M2) phase (1.35 ± 1.6 vs. 2 ± 3.87, P value: 0.4) and the number of Grade A, embryo (1.2 ± 1.3 vs. 1.1 ± 1.4, P value: 0.7). Conclusions: Simvastatin effectively improved hyperandrogenism signs and symptoms in patients with PCO, but this effect as a pretreatment regiment was not more expressive than metformin in ICSI cycle outcome. PMID:26756007

  12. Comparison of SPECT imaging using monoclonal antibodies with computed tomography (CT) and ultrasonography (US) for detection of recurrences of colorectal carcinoma: A prospective clinical study

    SciTech Connect

    Chatal, J.F.; Saccavini, J.C.; Douillard, J.Y.; Curtet, C.; Kremer, M.; Le Mevel, B.

    1985-05-01

    A prospective clinical study compared SPECT imaging, ultrasonography (US), and computed tomography (CT) in 22 patients clinically or biologically (increased CEA and/or CA 19-9 serum concentration) suspected of recurrence of colorectal carcinoma. The recordings were performed 3 to 5 days after injection of 111 to 129.5 MBq of cocktail of I-131-labeled anti-CEA and 19-9 (F(ab')2 fragments) monoclonal antibodies. Twenty nine tumor sites were demonstrated by surgery or concordant results of conventional diagnostic methods. SPECT visualized 21 of these 29 tumor sites (72%). It was negative in 4 cases with no demonstrated recurrence (by any method and follow-up). With respect to localization of tumor sites, SPECT visualized 7/12 liver metastases, 8/8 local pelvic recurrences and 6/8 abdominal recurrences. CT and US, systematically performed blind after SPECT, respectively visualized 9/10 and 9/12 liver metastases, 7/12 and 4/13 pelvic and abdominal recurrences. Image interpretation of SPECT was difficult due to poor tumor contrast and the large number of low-intensity, nonspecific radioactive foci. A focus had to recur in at least 3 successive slices to be considered pathological. Four tumor sites were visualized with SPECT and not with US and CT (negative or uncertain results). SPECT would appear to be useful for localizing pelvic or abdominal recurrences in cases in which interpretation of US and CT images is difficult, often because their nonspecific approach does not make it possible to differentiate a tumor recurrence from post-operative anatomical changes.

  13. PREVALENCE OF VALVULAR REGURGITATIONS IN CLINICALLY HEALTHY CAPTIVE LEOPARDS AND CHEETAHS: A PROSPECTIVE STUDY FROM THE WILDLIFE CARDIOLOGY (WLC) GROUP (2008-2013).

    PubMed

    Chai, Norin; Petit, Thierry; Kohl, Muriel; Bourgeois, Aude; Gouni, Vassiliki; Trehiou-Sechi, Emilie; Misbach, Charlotte; Petit, Amandine; Damoiseaux, Cécile; Garrigou, Audrey; Guepin, Raphaëlle; Pouchelon, Jean Louis; Chetboul, Valérie

    2015-09-01

    The purpose of this prospective study was to evaluate transthoracic echocardiograms from clinically healthy large felids for the presence of valvular regurgitations (VR). Physiologic VR commonly occur in normal dogs and cats, but the percentage of large felids with VR has not been previously reported. During a 5-yr study period (2008-2013), 28 healthy animals were evaluated under general anesthesia: 16 cheetahs (Acinonyx jubatus soemmeringuii) with a mean age of 1.5±0.8 yr (range 0.7-3.5 yr), 5 Amur leopards (Panthera pardus orientalis), 1 snow leopard (Uncia uncia), and 6 clouded leopards (Neofelis nebulosa). For this study, all the leopards were gathered in one so-called "leopards group" with a mean age of 2.8±3.4 yr (range 0.3-10.7 yr). All valves observed in each view were examined for evidence of regurgitant jets and turbulent blood flow using the color-flow Doppler mode. Valves were also examined for structural changes. Mitral valve and aortic cusp abnormalities were considered to be of congenital origin. Mitral valve lesions led to mitral insufficiency in all the felids. Aortic cusp abnormalities led to aortic regurgitation in 94% of the cheetahs and 67% of the leopards. Leopards showed a predominance of early systolic mitral regurgitations, whereas all the mitral regurgitation jets in cheetahs were holosystolic. Tricuspid regurgitation was found in 81% of the cheetahs and in 50% of the leopards, whereas pulmonic regurgitation was detected in 44% of the cheetahs and 33% of the leopards. Interestingly, none of these tricuspid and pulmonic regurgitations were associated with two-dimensional structural valve abnormalities, thus suggesting their physiologic origin, as described in humans, cats, and dogs. In conclusion, subclinical valvular diseases are common in apparently healthy leopards and cheetahs. Longitudinal follow-up of affected animals is therefore required to assess their clinical outcome.

  14. A prospective observational study to evaluate G-CSF usage in patients with solid tumors receiving myelosuppressive chemotherapy in Italian clinical oncology practice.

    PubMed

    Barni, S; Lorusso, V; Giordano, M; Sogno, G; Gamucci, T; Santoro, A; Passalacqua, R; Iaffaioli, V; Zilembo, N; Mencoboni, M; Roselli, M; Pappagallo, G; Pronzato, P

    2014-01-01

    Febrile neutropenia (FN) is a severe dose-limiting side effect of myelosuppressive chemotherapy in patients with solid tumors. Clinical practice guidelines recommend primary prophylaxis with G-CSF in patients with an overall ≥ 20 % risk of FN. AIOM Italian guidelines recommend starting G-CSF within 24-72 h after chemotherapy; for daily G-CSF, administration should continue until the absolute neutrophil count (ANC) is 1 × 10(9)/L post-nadir and should not be terminated after ANC increase in the early days of administration. The aim of this study was to assess guideline adherence in oncology practice in Italy. In this multicenter, prospective, observational study, patients were enrolled at the first G-CSF use in any cycle and were followed for two subsequent cycles (or until the end of chemotherapy if less than two additional cycles). Primary objective was to explore G-CSF use in Italian clinical practice; therefore, data were collected on the G-CSF type, timing of administration, and number of doses. 512 eligible patients were enrolled (median age, 62). The most common tumor types were breast (36 %), lung (18 %), and colorectal (13 %). A total of 1,164 G-CSF cycles (daily G-CSF, 718; pegfilgrastim, 446) were observed. Daily G-CSF was administered later than 72 h after chemotherapy in 42 % of cycles, and the median [range] number of doses was four [1, 10]. Pegfilgrastim was administered later than 72 h in 8 % of cycles. G-CSF prophylaxis in Italy is frequently administered in a manner which is not supported by evidence-based guidelines. As this practice may lead to poor outcomes, educational initiatives are recommended. PMID:24307348

  15. PREVALENCE OF VALVULAR REGURGITATIONS IN CLINICALLY HEALTHY CAPTIVE LEOPARDS AND CHEETAHS: A PROSPECTIVE STUDY FROM THE WILDLIFE CARDIOLOGY (WLC) GROUP (2008-2013).

    PubMed

    Chai, Norin; Petit, Thierry; Kohl, Muriel; Bourgeois, Aude; Gouni, Vassiliki; Trehiou-Sechi, Emilie; Misbach, Charlotte; Petit, Amandine; Damoiseaux, Cécile; Garrigou, Audrey; Guepin, Raphaëlle; Pouchelon, Jean Louis; Chetboul, Valérie

    2015-09-01

    The purpose of this prospective study was to evaluate transthoracic echocardiograms from clinically healthy large felids for the presence of valvular regurgitations (VR). Physiologic VR commonly occur in normal dogs and cats, but the percentage of large felids with VR has not been previously reported. During a 5-yr study period (2008-2013), 28 healthy animals were evaluated under general anesthesia: 16 cheetahs (Acinonyx jubatus soemmeringuii) with a mean age of 1.5±0.8 yr (range 0.7-3.5 yr), 5 Amur leopards (Panthera pardus orientalis), 1 snow leopard (Uncia uncia), and 6 clouded leopards (Neofelis nebulosa). For this study, all the leopards were gathered in one so-called "leopards group" with a mean age of 2.8±3.4 yr (range 0.3-10.7 yr). All valves observed in each view were examined for evidence of regurgitant jets and turbulent blood flow using the color-flow Doppler mode. Valves were also examined for structural changes. Mitral valve and aortic cusp abnormalities were considered to be of congenital origin. Mitral valve lesions led to mitral insufficiency in all the felids. Aortic cusp abnormalities led to aortic regurgitation in 94% of the cheetahs and 67% of the leopards. Leopards showed a predominance of early systolic mitral regurgitations, whereas all the mitral regurgitation jets in cheetahs were holosystolic. Tricuspid regurgitation was found in 81% of the cheetahs and in 50% of the leopards, whereas pulmonic regurgitation was detected in 44% of the cheetahs and 33% of the leopards. Interestingly, none of these tricuspid and pulmonic regurgitations were associated with two-dimensional structural valve abnormalities, thus suggesting their physiologic origin, as described in humans, cats, and dogs. In conclusion, subclinical valvular diseases are common in apparently healthy leopards and cheetahs. Longitudinal follow-up of affected animals is therefore required to assess their clinical outcome. PMID:26352956

  16. A prospective, randomized clinical study evaluating the effect of transdermal continuous oxygen therapy on biological processes and foot ulcer healing in persons with diabetes mellitus.

    PubMed

    Driver, Vickie R; Yao, Min; Kantarci, Alpdogan; Gu, Guosheng; Park, Nanjin; Hasturk, Hatice

    2013-11-01

    Hypoxia is a major factor in delayed wound healing. The aim of this prospective, randomized, clinical trial was to compare outcomes of treatment in persons with chronic diabetic foot ulcers (DFUs) randomly assigned to transdermal continuous oxygen therapy (TCOT) for 4 weeks as an adjunct to standard care (debridement, offloading, and moisture). Nine patients (age 58.6±7.1, range 38-73 years) received TCOT (treatment group) and eight patients (age 59.9±12.6, range 35-76 years) received standard care alone (control group). Most patients (12) were male, and all had a Wagner I or II foot ulcer for an average of 14 (control group) or 20 months (treatment group). Weekly wound measurements and wound tissue biopsies were obtained and wound fluid collected. Levels of pro-inflammatory cytokines and proteases in wound fluid samples were analyzed using Luminex-based multiplex assays. Tissue-resident macrophages were quantified by immunohistochemistry. At week 4, average wound size reduction was 87% (range 55.7% to 100%) in the treatment group compared to 46% (15% to 99%) in the control group (P <0.05). Changes in cytokine levels (IL-6, IL-8) and proteinases (MMP-1,-2,-9, TIMP-1) at weeks 2 to 4 in wound fluid correlated with clinical findings. CD68+ macrophage counts showed statistically significant reduction in response to TCOT compared to the control group (P <0.01). The results of this study show that TCOT may facilitate healing of DFUs by reversing the inflammatory process through reduction in pro-inflammatory cytokines and tissue-degrading proteases. Additional research to elucidate the effects of this treatment on complete healing and increase understanding about the role of wound fluid analysis is needed.

  17. Video-based feedback of oral clinical presentations reduces the anxiety of ICU medical students: a multicentre, prospective, randomized study

    PubMed Central

    2014-01-01

    Background Oral presentations of clinical cases by medical students during medical rounds in hospital wards are a source of anxiety and little is known about how this anxiety can be alleviated. The objective of this study was to investigate whether video-based feedback of public oral presentations can reduce anxiety in 4th year medical students. Methods Multicentre randomized study conducted in six intensive care units (ICU) and emergency departments (ED) in France over a 9-month period in 2012. One hundred and forty two 4th year medical students were randomized to two groups: intervention and control. Students in the intervention group were recorded while making an oral presentation of a patient during morning ward rounds, followed by video-based feedback. Students in the control group conducted presented classical oral presentations without being filmed and with no formal feedback. Anxiety levels during a public oral presentation were assessed using the Spielberger State Anxiety Inventory (STAI-S). The primary outcome was the difference in STAI-S scores between groups at the beginning and at the end of a 3-month ICU or ED internship. Results Seventy four students were randomized to the ‘video-based feedback’ group and 68 were randomized to the control group. In both groups, STAI-S scores were significantly lower after 3 months of internship. However, the reduction in STAI-S scores was significantly greater in the “video-based feedback” group than in controls (-9.2 ± 9.3 vs. –4.6 ± 8.2, p = 0.024. Compared to the control group, significantly fewer students with high-level anxiety were observed in the “video-based feedback” group after 3 months of internship (68 vs. 28%, p <0.001). Conclusions Compared to “usual practice”, video-assisted oral feedback reduced anxiety and significantly decreased the proportion of students experiencing severe anxiety. PMID:24885005

  18. MR Neurography and Diffusion Tensor Imaging: Origins, History & Clinical Impact of the first 50,000 cases with an Assessment of Efficacy and Utility in a Prospective 5,000 Patient Study Group

    PubMed Central

    Filler, Aaron

    2009-01-01

    Objective Methods were invented that made it possible to image peripheral nerves in the body and to image neural tracts in the brain. Over a 15 year period, these techniques – MR Neurography and Diffusion Tensor Imaging – were then deployed in the clinical and research community and applied to about 50,000 patients. Within this group, about 5,000 patients having MR Neurography were carefully tracked on a prospective basis. Method In the study group a uniform imaging methodology was applied and all images were reviewed and registered by referral source, clinical indication, efficacy of imaging and quality. Various classes of image findings were identified and subjected to a variety of small targeted prospective outcome studies. Those findings demonstrated to be clinically significant were then tracked in the larger clinical volume data set. Results MR Neurography demonstrates mechanical distortion of nerves, hyperintensity consistent with nerve irritation, nerve swelling, discontinuity, relations of nerves to masses, and image features revealing distortion of nerve at entrapment points. These findings are often clinically relevant and warrant full consideration in the diagnostic process. They result in specific pathologic diagnoses that are comparable to electrodiagnostic testing in clinical efficacy. Conclusions MR Neurography and DTI neural tract imaging have been validated as indispensable clinical diagnostic methods that provide reliable anatomical pathological information. There is no alternative diagnostic method in many situations. With the elapse of 15 years, tens of thousands of imaging studies, and hundreds of publications, these methods should no longer be considered experimental. PMID:19927075

  19. Effect of an analgo-sedation protocol for neurointensive patients: a two-phase interventional non-randomized pilot study

    PubMed Central

    2010-01-01

    Introduction Sedation protocols are needed for neurointensive patients. The aim of this pilot study was to describe sedation practice at a neurointensive care unit and to assess the feasibility and efficacy of a new sedation protocol. The primary outcomes were a shift from sedation-based to analgesia-based sedation and improved pain management. The secondary outcomes were a reduction in unplanned extubations and duration of sedation. Methods This was a two-phase (before-after), prospective controlled study at a university-affiliated, 14-bed neurointensive care unit in Denmark. The sample included patients requiring mechanical ventilation for at least 48 hours treated with continuous sedative and analgesic infusions or both. During the observation phase the participants (n = 106) were sedated as usual (non-protocolized), and during the intervention phase the participants (n = 109) were managed according to a new sedation protocol. Results Our study showed a shift toward analgo-sedation, suggesting feasibility of the protocol. We found a significant reduction in the use of propofol (P < .001) and midazolam (P = .001) and an increase in fentanyl (P < .001) and remifentanil (P = .003). Patients selected for daily sedation interruption woke up faster, and estimates of pain free patients increased from 56.8% to 82.7% (P < .001), suggesting efficacy of the protocol. The duration of sedation and unplanned extubations were unchanged. Conclusions Our pilot study showed feasibility and partial efficacy of our protocol. Some neurointensive patients might not benefit from protocolized practice. We recommend an interdisciplinary effort to target patients requiring less sedation, as issues of oversedation and inadequate pain management still need more attention. Trial registration ISRCTN80999859. PMID:20403186

  20. Effects of Acupuncture Stimulation on the Radial artery’s Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

    PubMed Central

    Shin, Jae-Young; Lee, Jun-Hwan; Ku, Boncho; Bae, Jang Han; un, Min-Ho; Kim, Jaeuk U.; Kim, Tae-Hun

    2016-01-01

    Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery’s pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz (SE10-30Hz) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University’s Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer

  1. Effects of Acupuncture Stimulation on the Radial artery’s Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

    PubMed Central

    Shin, Jae-Young; Lee, Jun-Hwan; Ku, Boncho; Bae, Jang Han; un, Min-Ho; Kim, Jaeuk U.; Kim, Tae-Hun

    2016-01-01

    Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery’s pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz (SE10-30Hz) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University’s Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer

  2. SU-D-17A-04: The Impact of Audiovisual Biofeedback On Image Quality During 4D Functional and Anatomic Imaging: Results of a Prospective Clinical Trial

    SciTech Connect

    Keall, P; Pollock, S; Yang, J; Diehn, M; Berger, J; Graves, E; Loo, B; Yamamoto, T

    2014-06-01

    Purpose: The ability of audiovisual (AV) biofeedback to improve breathing regularity has not previously been investigated for functional imaging studies. The purpose of this study was to investigate the impact of AV biofeedback on 4D-PET and 4D-CT image quality in a prospective clinical trial. We hypothesized that motion blurring in 4D-PET images and the number of artifacts in 4D-CT images are reduced using AV biofeedback. Methods: AV biofeedback is a real-time, interactive and personalized system designed to help a patient self-regulate his/her breathing using a patient-specific representative waveform and musical guides. In an IRB-approved prospective clinical trial, 4D-PET and 4D-CT images of 10 lung cancer patients were acquired with AV biofeedback (AV) and free breathing (FB). The 4D-PET images in 6 respiratory bins were analyzed for motion blurring by: (1) decrease of GTVPET and (2) increase of SUVmax in 4-DPET compared to 3D-PET. The 4D-CT images were analyzed for artifacts by: (1) comparing normalized cross correlation-based scores (NCCS); and (2) quantifying a visual assessment score (VAS). A two-tailed paired t-test was used to test the hypotheses. Results: The impact of AV biofeedback on 4D-PET and 4D-CT images varied widely between patients, suggesting inconsistent patient comprehension and capability. Overall, the 4D-PET decrease of GTVPET was 2.0±3.0cm3 with AV and 2.3±3.9cm{sup 3} for FB (p=0.61). The 4D-PET increase of SUVmax was 1.6±1.0 with AV and 1.1±0.8 with FB (p=0.002). The 4D-CT NCCS were 0.65±0.27 with AV and 0.60±0.32 for FB (p=0.32). The 4D-CT VAS was 0.0±2.7 (p=ns). Conclusion: A 10-patient study demonstrated a statistically significant reduction of motion blurring of AV over FB for 1/2 functional 4D-PET imaging metrics. No difference between AV and FB was found for 2 anatomic 4D-CT imaging metrics. Future studies will focus on optimizing the human-computer interface and including patient training sessions for improved

  3. Professional Rugby Union players have a 60% greater risk of time loss injury after concussion: a 2-season prospective study of clinical outcomes

    PubMed Central

    Cross, Matthew; Kemp, Simon; Smith, Andrew; Trewartha, Grant; Stokes, Keith

    2016-01-01

    Aim To investigate incidence of concussion, clinical outcomes and subsequent injury risk following concussion. Methods In a two-season (2012/2013, 2013/2014) prospective cohort study, incidence of diagnosed match concussions (injuries/1000 h), median time interval to subsequent injury of any type (survival time) and time spent at each stage of the graduated return to play pathway were determined in 810 professional Rugby Union players (1176 player seasons). Results Match concussion incidence was 8.9/1000 h with over 50% occurring in the tackle. Subsequent incidence of any injury for players who returned to play in the same season following a diagnosed concussion (122/1000 h, 95% CI 106 to 141) was 60% higher (IRR 1.6, 95% CI 1.4 to 1.8) than for those who did not sustain a concussion (76/1000 h, 95% CI 72 to 80). Median time to next injury following return to play was shorter following concussion (53 days, 95% CI 41 to 64) than following non-concussive injuries (114 days, 95% CI 85 to 143). 38% of players reported recurrence of symptoms or failed to match their baseline neurocognitive test during the graduated return to play protocol. Summary and conclusions Players who returned to play in the same season after a diagnosed concussion had a 60% greater risk of time-loss injury than players without concussion. A substantial proportion of players reported recurrence of symptoms or failed to match baseline neurocognitive test scores during graduated return to play. These data pave the way for trials of more conservative and comprehensive graduated return to play protocols, with a greater focus on active rehabilitation. PMID:26626266

  4. Prospective double-blind preoperative pain clinic screening before microsurgical denervation of the spermatic cord in patients with testicular pain syndrome.

    PubMed

    Oomen, Robert J A; Witjens, Annemijke C; van Wijck, Albert J M; Grobbee, Diederik E; Lock, Tycho M T W

    2014-09-01

    Testicular pain syndrome (TPS), defined as an intermittent or constant pain in one or both testicles for at least 3 months, resulting in significant reduction of daily activities, is common. Microsurgical denervation of the spermatic cord (MDSC) has been suggested as an effective treatment option. The study population comprised 180 TPS patients admitted to our outpatient urology clinic between 1999 and 2011. On 3 different occasions, patients were offered a double-blind, placebo-controlled temporary blockade of the spermatic cord. A single blockade consisted of 10 mL 2% lidocaine, 10 mL 0.25% bupivacaine, or 10 mL 0.9% sodium chloride. If the results of these blockades were positive, MDSC was offered. All MDSCs were performed by a single urologist (M.T.W.T.L.) using an inguinal approach. Pain reduction was determined at prospective follow-up. This study evaluated 180 patients. Most patients (61.1%) had undergone a scrotal or inguinal procedure. Patients had complaints during sexual activities (51.7%), sitting (37.5%), and/or cycling (36.7%); 189 randomized blockades were offered to all patients. There was a positive response in 37% and a negative response in 51%. MDSC was performed on 58 testicular units, including 3 patients with a negative outcome of the blockades. At mean follow-up of 42.8 months, 86.2% had a ≥ 50% reduction of pain and 51.7% were completely pain free. MDSC is a valuable treatment option for TPS patients because in this study 86.2% experienced a ≥ 50% reduction of pain. To prevent superfluous diagnostics and treatment, it is mandatory to follow a systematic protocol in the treatment of TPS.

  5. Circumcision with “no-flip Shang Ring” and “Dorsal Slit” methods for adult males: a single-centered, prospective, clinical study

    PubMed Central

    Lei, Jun-Hao; Liu, Liang-Ren; Wei, Qiang; Xue, Wen-Ben; Song, Tu-Run; Yan, Shi-Bing; Yang, Lu; Han, Ping; Zhu, Yu-Chun

    2016-01-01

    This paper was aimed to compare the clinical effectiveness and safety of adult male circumcision using the Shang Ring™ (SR) with the no-flip technique compared with Dorsal Slit (DS) surgical method. A single-centered, prospective study was conducted at the West China Hospital, where patients were circumcised using the no-flip SR (n = 408) or the DS (n = 94) procedure. The adverse events (AEs) and satisfaction were recorded for both groups, and ring-removal time and percentage of delayed removals were recorded for the SR group. Finally, complete follow-up data were collected for 76.1% of patients (SR: n = 306; DS: n = 76). The average ring-removal time for the SR group was 17.62 ± 6.30 days. The operation time (P < 0.001), pain scores during the procedure (P < 0.001) and at 24 h postoperatively (P < 0.001), bleeding (P = 0.001), infection (P = 0.034), and satisfaction with penile appearance (P < 0.001) in the SR group were superior to those in the DS group. After two postoperative weeks, the percentage of patients with edema in the SR group (P = 0.029) was higher but no differences were found at 4 weeks (P = 0.185) between the two groups. In conclusions, the no-flip SR method was found to be superior to the DS method for its short operation time (<5 min), involving less pain, bleeding, infection, and resulting in a satisfactory appearance. However, the time for recovery from edema took longer, and patients may wear device for 2–3 weeks after the procedure. PMID:26585694

  6. 5-Year control and treatment of edema and increased capillary filtration in venous hypertension and diabetic microangiopathy using O-(beta-hydroxyethyl)-rutosides: a prospective comparative clinical registry.

    PubMed

    Belcaro, Gianni; Cesarone, Maria Rosaria; Ledda, Andrea; Cacchio, Marisa; Ruffini, Irma; Ricci, Andrea; Ippolito, Edmondo; Di Renzo, Andrea; Dugall, Mark; Corsi, Marcello; Marino Santarelli, Anna Rita; Grossi, Maria Giovanna

    2008-01-01

    This independent prospective controlled trial evaluates the efficacy of O-(beta-hydroxyethyl)-rutosides (HR) during 5 years of administration against signs and symptoms and further degeneration of microcirculatory disturbances. The protective effect of HR in preventing end-point complications such as venous ulceration is evaluated. This study is based on evaluation of edema and the capillary filtration rate (CFR) in association with a clinical score scale. Patients having a severe degree of chronic venous insufficiency (CVI) and venous microangiopathy and completing at least 5 years of treatment are included. The following 4 groups are considered: group A (patients with CVI but without diabetes mellitus, receiving 1500 mg/d of HR), group B (patients with CVI and diabetes mellitus, receiving 2 g/d of HR), group C (control subjects receiving no pharmacologic or compression treatment), and group D (patients using elastic compression stockings only). All patients received the "best" available treatment. No adverse effects or intolerance is noted, with good compliance (>85%). In group A, there is a statistically significant decrease in the CFR during 5 years of follow-up. In group B, the decrease in the CFR is greater than that in group A. Reductions in edema, swelling, and the CFR during 5 years are notable, and values approach normal levels. During 5 years, HR is effective in treating venous edema and hypertension and in preventing deterioration of the distal venous system. The prevention of ulcerations with HR is another important observation. The effects of HR seem to be partially dose related, and tolerability and compliance are good.

  7. A randomized prospective mechanistic cardiac magnetic resonance study correlating catheter stability, late gadolinium enhancement and 3 year clinical outcomes in robotically assisted vs. standard catheter ablation

    PubMed Central

    Arujuna, Aruna; Karim, Rashed; Zarinabad, Niloufar; Gill, Jaspal; Rhode, Kawal; Schaeffter, Tobias; Wright, Matthew; Rinaldi, C. Aldo; Cooklin, Michael; Razavi, Reza; O'Neill, Mark D.; Gill, Jaswinder S.

    2015-01-01

    Aims To prospectively compare cardiac magnetic resonance late gadolinium enhancement (LGE) findings created by standard vs. robotically assisted catheter ablation lesions and correlate these with clinical outcomes. Methods and results Forty paroxysmal atrial fibrillation patients (mean age 54 ± 13.8 years) undergoing first left atrial ablation were randomized to either robotic-assisted navigation (Hansen Sensei® X) or standard navigation. Pre-procedural, acute (24 h post-procedure) and late (beyond 3 months) scans were performed with LGE and T2W imaging sequences and percentage circumferential enhancement around the pulmonary vein (PV) antra were quantified. Baseline pre-procedural enhancements were similar in both groups. On acute imaging, mean % encirclements by LGE and T2W signal were 72% and 80% in the robotic group vs. 60% (P = 0.002) and 76%(P = 0.45) for standard ablation. On late imaging, the T2W signal resolved to baseline in both groups. Late gadolinium enhancement remained the predominant signal with 56% encirclement in the robotic group vs. 45% in the standard group (P = 0.04). At 6 months follow-up, arrhythmia-free patients had an almost similar mean LGE encirclement (robotic 64%, standard 60%, P = 0.45) but in recurrences, LGE was higher in the robotic group (43% vs. 30%, P = 0.001). At mean 3 years follow-up, 1.3 procedures were performed in the robotic group compared with 1.9 (P < 0.001) in the standard to achieve a success rate of 80% vs. 75%. Conclusion Robotically assisted ablation results in greater LGE around the PV antrum. Effective lesions created through improved catheter stability and contact force during initial treatment may have a role in reducing subsequent re-do procedures. PMID:25687748

  8. A prospective randomized comparison of radiation therapy plus lonidamine versus radiation therapy plus placebo as initial treatment of clinically localized but nonresectable nonsmall cell lung cancer

    SciTech Connect

    Scarantino, C.W.; McCunniff, A.J.; Evans, G.; Young, C.W.; Paggiarino, D.A.

    1994-07-30

    The purpose was, by means of a multicenter, prospective randomized, placebo-controlled study, to assess the impact of adding the radiation-enhancing agent lonidamine to standard {open_quotes}curative-intent{close_quotes} radiation therapy upon overall survival, progression-free survival, and local progression-free survival of patients with clinically localized but nonresectable nonsmall cell lung cancer. Lonidamine, or the lonidamine-placebo, was administered at a dose of 265 mg/m{sup 2} in three divided daily doses. Drug therapy began 2 days prior to the initiation of radiation therapy and continued until progression of disease mandated a change in therapy. The radiation therapy dose was 55-60 Gy, at a daily dose of 1.8 Gy and five treatments per week. Patients with clinical Stage II or III nonsmall cell lung cancer were stratified within the treatment center, and within two histologic strata: epidermoid vs. other nonsmall cell cancers. A total of 310 patients were enlisted on study, 152 on the placebo arm and 158 on the lonidamine arm. The median survival durations were 326 and 392 days for the placebo and lonidamine-treated groups respectively, p = 0.41 for a comparison of the survival curves. Median progression-free survival and median local progression-free survival durations were 197 days and 341 days for placebo + radiation therapy vs. 230 days and 300 days for lonidamine + radiation therapy; p-values for the respective curves were 0.75 and 0.42. Although there were proportionately more lonidamine-treated patients than placebo-treated patients demonstrating continued local control in excess of 12 months, the numbers of patients still at risk after 24 months were too small for meaningful statistical analysis. This multicenter Phase III study failed to demonstrate a significant advantage in the lonidamine-treated population in overall patient survival, in progression-free survival, or in the median duration of local control. 25 refs., 3 figs., 3 tabs.

  9. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

    PubMed Central

    Saha, Suparna Ganguly; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

    2016-01-01

    Introduction It is generally accepted that achieving complete anaesthesia with an Inferior Alveolar Nerve Block (IANB) in mandibular molars with symptomatic irreversible pulpitis is more challenging than for other teeth. Therefore, administration of Non-Steroidal Anti-Inflammatory Agents (NSAIDs) 1 hour prior to anaesthetic administration has been proposed as a means to increase the efficacy of the IANB in such patients. Aim The purpose of this prospective, double-blind, randomized clinical trial was to determine the effect of administration of oral premedication with ketorolac (KETO) and diclofenac potassium (DP) on the efficacy of IANB in patients with irreversible pulpitis. Materials and Methods One hundred and fifty patients with irreversible pulpitis were evaluated preoperatively for pain using Heft Parker visual analogue scale, after which they were randomly divided into three groups. The subjects received identical tablets of ketorolac, diclofenac pottasium or cellulose powder (placebo), 1 hour prior to administration of IANB with 2% lidocaine containing 1:200 000 epinephrine. Lip numbness as well as positive and negative responses to cold test were ascertained. Additionally pain score of each patient was recorded during cavity preparation and root canal instrumentation. Success was defined as the absence of pain or mild pain based on the visual analog scale readings. The data was analysed using One-Way Anova, Post-Hoc Tukey pair wise, Paired T – Test and chi-square test. Trial Registery Number is 4722/2015 for this clinical trial study. Results There were no significant differences with respect to age (p =0.098), gender (p = 0.801) and pre-VAS score (DP-KETO p=0.645, PLAC-KETO p =0.964, PLAC-DP p = 0.801) between the three groups. All patients had subjective lip anaesthesia with the IAN blocks. Patients of all the three groups reported a significant decrease in active pain after local anaesthesia (p< 0.05). The post injection VAS Score was least in group

  10. The Effect of Information About Gynecological Examination on the Anxiety Level of Women Applying to Gynecology Clinics: A Prospective, Randomized, Controlled Study

    PubMed Central

    Ulker, Kahraman; Kivrak, Yuksel

    2016-01-01

    Background: Crowded hospital outpatient clinics and endless waiting lines that make patients feel overlooked tend to exaggerate patients’ anxiety levels. In addition, fear of pain, shyness, religious and traditional thoughts, women’s sexual role in society, and previous information and experience also contribute to people’s anxiety levels with regard to gynecologic examination. Objectives: We aimed to analyze the effect of specific information about gynecologic examination on anxiety levels of women applying to gynecology clinics. Materials and Methods: In this randomized prospective study, the women applying for a gynecological examination were randomly allocated into control, intervention 1, and intervention 2 groups. Power analysis indicated that in order to achieve a one-point decrease from the previous anxiety score of 43.85 ± 5.41 at one side alpha 0.05 with a power of 80%, at least 79 women were needed in each group. Four medical school students interviewed 75 women (25 in control, 25 in intervention 1, and 25 in intervention 2). The data were collected using the demographic, social, and economic data form, and the Turkish version of the state-trait anxiety inventory (STAI). The women in the intervention 1 and 2 groups were instructed to read a paper that contained brief information about the gynecological examination procedure and the profits obtained from forests, respectively. All participants, including the women in the control group, filled the STAI by themselves. The three groups were compared appropriately. Results: The demographics pertaining to age, gravidity and parity, miscarriage, induced abortion, ectopic pregnancy, offspring number, place of residence, working status, education level and previous experience of gynecological examination did not differ among the groups (P > 0.05). According to the STAI scores, all groups had mild state (control: 40.20 ± 10.53, intervention 1: 42.00 ± 11.98, and intervention 2: 39.53 ± 10.32) and severe

  11. Prospective survey of veterinary practitioners’ primary assessment of equine colic: clinical features, diagnoses, and treatment of 120 cases of large colon impaction

    PubMed Central

    2014-01-01

    Background Large colon impactions are a common cause of colic in the horse. There are no scientific reports on the clinical presentation, diagnostic tests and treatments used in first opinion practice for large colon impaction cases. The aim of this study was to describe the presentation, diagnostic approach and treatment at the primary assessment of horses with large colon impactions. Methods Data were collected prospectively from veterinary practitioners on the primary assessment of equine colic cases over a 12 month period. Inclusion criteria were a diagnosis of primary large colon impaction and positive findings on rectal examination. Data recorded for each case included history, signalment, clinical and diagnostic findings, treatment on primary assessment and final case outcome. Case outcomes were categorised into three groups: simple medical (resolved with single treatment), complicated medical (resolved with multiple medical treatments) and critical (required surgery, were euthanased or died). Univariable analysis using one-way ANOVA and Tukey’s post-hoc test, Kruskal Wallis with Dunn’s post-hoc test and Chi squared analysis were used to compare between different outcome categories. Results 1032 colic cases were submitted by veterinary practitioners: 120 cases met the inclusion criteria for large colon impaction. Fifty three percent of cases were categorised as simple medical, 36.6% as complicated medical, and 9.2% as critical. Most cases (42.1%) occurred during the winter. Fifty nine percent of horses had had a recent change in management, 43% of horses were not ridden, and 12.5% had a recent / current musculoskeletal injury. Mean heart rate was 43bpm (range 26-88) and most cases showed mild signs of pain (67.5%) and reduced gut sounds (76%). Heart rate was significantly increased and gut sounds significantly decreased in critical compared to simple medical cases (p<0.05). Fifty different treatment combinations were used, with NSAIDs (93%) and oral

  12. A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers.

    PubMed

    Buzzi, Marcelo; de Freitas, Franciele; Winter, Marcos

    2016-03-01

    Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs. Patients diagnosed with a stable neuropathic ulcer of >3 months' duration; ranging in size from 0.5-40 cm(2); without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18-90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients' blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients' ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) - 17 women, average age 62 years (range 44-82 years), average glycemic level 153 mg

  13. Raltegravir use prospectively assessed in a major HIV outpatient clinic in Italy: sample population, virological-immunological activity, and tolerability profile.

    PubMed

    Manfredi, Roberto; Calza, Leonardo; Marinacci, Ginevra; Cascavilla, Alessandra; Colangeli, Vincenzo; Salvadori, Caterina; Martelli, Giulia; Appolloni, Lucia; Puggioli, Cristina; Viale, Pierluigi

    2014-12-01

    Raltegravir, as the first HIV integrase inhibitor, has been used and prospectively monitored since 2010 in our HIV outpatient centre, where over 1,200 patients are monitored. The aim of our report is to perform an interim assessment of the background, the safety profile and the clinical-laboratory monitoring of all patients treated with a combination antiretroviral therapy (cART) including raltegravir, for at least 12 months. In all, 109 pretreated patients started a raltegravir-containing cART when aged 44.8 plus or minus 19.2 years, with a history of HIV infection lasting 13.4 plus or minus 9.7 years. All subjects were monitored for at least 12 months (mean 17.2 plus or minus 10.3 months). In the vast majority of cases (93 of 109: 85.3%), multiple (3-16) prior cART changes prompted raltegravir introduction in advanced-salvage lines: 72 of 109 (66.1%) patients had even developed a concurrent triple-class resistance to anti-HIV compounds. The most frequent companion antiretroviral agents were: darunavir/ritonavir (75 cases), maraviroc (47 subjects), and etravirine (38 cases). The most common underlying conditions were: AIDS (46 patients), liver cirrhosis (31 cases), AIDS-related or other malignancies (23 cases), and major cardio-cerebro-vascular events (18 cases). A chronic HCV and HBV hepatitis were of concern in 48 and 23 patients, respectively. The adjunct of raltegravir favourably affected all clinical-laboratory markers of HIV disease progression, and those of the broad spectrum of comorbidities, except for two patients who failed the raltegravir-containing cART due to insufficient adherence. Despite the already compromised clinical situation, a minority of subjects experienced mild-transient clinical-laboratory untoward events possibly attributable to raltegravir, such that no patients discontinued raltegravir during the observation period. Only three AIDS-defining conditions became apparent during raltegravir-based cART; chemotherapy and/or radiotherapy

  14. A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers.

    PubMed

    Buzzi, Marcelo; de Freitas, Franciele; Winter, Marcos

    2016-03-01

    Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs. Patients diagnosed with a stable neuropathic ulcer of >3 months' duration; ranging in size from 0.5-40 cm(2); without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18-90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients' blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients' ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) - 17 women, average age 62 years (range 44-82 years), average glycemic level 153 mg

  15. A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

    ERIC Educational Resources Information Center

    Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

    2012-01-01

    Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

  16. Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study

    PubMed Central

    Pivot, Xavier B.; Jacot, William; Naman, Hervé L.; Spaeth, Dominique; Misset, Jean-Louis; Largillier, Rémy; Sautiere, Jean-Loup; de Roquancourt, Anne; Pomel, Christophe; Rouanet, Philippe; Rouzier, Roman; Penault-Llorca, Frederique M.

    2015-01-01

    Background. The 21-gene Oncotype DX Recurrence Score assay is a validated assay to help decide the appropriate treatment for estrogen receptor-positive (ER+), early-stage breast cancer (EBC) in the adjuvant setting. The choice of adjuvant treatments might vary considerably in different countries according to various treatment guidelines. This prospective multicenter study is the first to assess the impact of the Oncotype DX assay in the French clinical setting. Methods. A total of 100 patients with ER+, human epidermal growth factor receptor 2-negative EBC, and node-negative (pN0) disease or micrometastases in up to 3 lymph nodes (pN1mi) were enrolled. Treatment recommendations, physicians’ confidence before and after knowing the Recurrence Score value, and physicians’ perception of the assay were recorded. Results. Of the 100 patients, 95 were evaluable (83 pN0, 12 pN1mi). Treatment recommendations changed in 37% of patients, predominantly from chemoendocrine to endocrine treatment alone. The proportion of patients recommended chemotherapy decreased from 52% pretest to 25% post-test. Of patients originally recommended chemotherapy, 61% were recommended endocrine treatment alone after receiving the Recurrence Score result. For both pN0 and pN1mi patients, post-test recommendations appeared to follow the Recurrence Score result for low and high values. Physicians’ confidence improved significantly. Conclusion. These are the first prospective data on the impact of the Oncotype DX assay on adjuvant treatment decisions in France. Using the assay was associated with a significant change in treatment decisions and an overall reduction in chemotherapy use. These data are consistent with those presented from European and non-European studies. Implications for Practice: This study shows that in estrogen receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer (either node-negative or with micrometastases in up to 3 lymph nodes

  17. A fast, easy circumcision procedure combining a CO2 laser and cyanoacrylate adhesive: a non-randomized comparative trial

    PubMed Central

    Gorgulu, Tahsin; Olgun, Abdulkerim; Torun, Merve; Kargi, Eksal

    2016-01-01

    ABSTRACT Background Circumcision is performed as a routine operation in many countries, more commonly for religious and cultural reasons than for indicated conditions, such as phimosis and balanitis. There are many techniques available, and recently electrocautery and both Nd:YAG and CO2 lasers, instead of blades, have been used for skin and mucosal incisions. However, the infection risk in circumcisions performed using a CO2 laser was 10% higher. There are also reports of sutureless procedures using cyanoacrylate, but these have higher risks of hematoma and hemorrhage. We combined a CO2 laser and cyanoacrylate to shorten the operation time and to decrease bleeding complications. Materials and Methods : Circumcisions were performed under general anesthesia with CO2 laser and cyanoacrylate combination in 75 6–9-year-old boys between May 2013 and August 2014 only for religious reasons. As a control, we compared them retrospectively with 75 age-matched patients who were circumcised using the conventional guillotine method in our clinic. Results No hematomas, bleeding, or wound infections were observed. One wound dehiscence (1.33%) occurred during the early postoperative period and healed without any additional procedures. The median operating time was 7 (range 6–9) minutes. The conventional guillotine group comprised one hematoma (1.3%), two wound dehiscences (2.6%), and two hemorrhages (2.6%), and the median operating time was 22 (range 20–26) minutes. The difference in surgical time was significant (p<0.001), with no significant difference in the rate of complications between the two groups. Conclusion The combined CO2 laser and cyanoacrylate procedure not only decreased the operating time markedly, but also eliminated the disadvantages associated with each individual procedure alone. PMID:27136476

  18. Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Incidence Rate of Healthcare-Associated Clostridium difficile Infection: A Non-Randomized, Stepped Wedge, Single-Site, Observational Study

    PubMed Central

    McArthur, Leslie

    2016-01-01

    Background The incidence rate of healthcare-associated Clostridium difficile infection (HA-CDI) is estimated at 1 in 100 patients. Antibiotic exposure is the most consistently reported risk factor for HA-CDI. Strategies to reduce the risk of HA-CDI have focused on reducing antibiotic utilization. Prospective audit and feedback is a commonly used antimicrobial stewardship intervention (ASi). The impact of this ASi on risk of HA-CDI is equivocal. This study examines the effectiveness of a prospective audit and feedback ASi on reducing the risk of HA-CDI. Methods Single-site, 339 bed community-hospital in Barrie, Ontario, Canada. Primary outcome is HA-CDI incidence rate. Daily prospective and audit ASi is the exposure variable. ASi implemented across 6 wards in a non-randomized, stepped wedge design. Criteria for ASi; any intravenous antibiotic use for ≥ 48 hrs, any oral fluoroquinolone or oral second generation cephalosporin use for ≥ 48 hrs, or any antimicrobial use for ≥ 5 days. HA-CDI cases and model covariates were aggregated by ward, year and month starting September 2008 and ending February 2016. Multi-level mixed effect negative binomial regression analysis was used to model the primary outcome, with intercept and slope coefficients for ward-level random effects estimated. Other covariates tested for inclusion in the final model were derived from previously published risk factors. Deviance residuals were used to assess the model’s goodness-of-fit. Findings The dataset included 486 observation periods, of which 350 were control periods and 136 were intervention periods. After accounting for all other model covariates, the estimated overall ASi incidence rate ratio (IRR) was 0.48 (95% 0.30, 0.79). The ASi effect was independent of antimicrobial utilization. The ASi did not seem to reduce the risk of Clostridium difficile infection on the surgery wards (IRR 0.87, 95% CI 0.45, 1.69) compared to the medicine wards (IRR 0.42, 95% CI 0.28, 0.63). The ward

  19. Clinical Utility of Sequential Minimal Residual Disease Measurements in the Context of Risk-based Therapy in Childhood Acute Lymphoblastic Leukemia: a Prospective Study

    PubMed Central

    Pui, Ching-Hon; Pei, Deqing; Coustan-Smith, Elaine; Jeha, Sima; Cheng, Cheng; Bowman, W Paul; Sandlund, John T; Ribeiro, Raul C; Rubnitz, Jeffrey E; Inaba, Hiroto; Bhojwani, Deepa; Gruber, Tanja A; Leung, Wing H; Downing, James R; Evans, William E; Relling, Mary V; Campana, Dario

    2015-01-01

    Summary Background The level of minimal residual disease (MRD) during remission induction is the most important prognostic indicator in acute lymphoblastic leukemia (ALL). We determined the clinical significance of MRD in the context of a prospective clinical study in which sequential MRD measurements were used to guide treatment decisions. Methods Between 2000 and 2007, 498 evaluable patients with newly diagnosed ALL were enrolled in St. Jude Study XV. Risk of relapse was provisionally classified as low, standard or high according to presenting clinical and laboratory features. Final risk assignment to determine treatment intensity was based mainly on MRD levels measured on days 19 and 46 of remission induction, and on week 7 of continuation treatment. Additional MRD determinations were made on weeks 17, 48 and 120 (end of therapy). Findings Regardless of the provisional risk classification, 10-year event-free survival was significantly inferior for patients with MRD ≥1% on day 19 compared with that of patients having lower MRD levels: 69.2% (95% CI 49.6–82.4, n=36) versus 95.5% (91.7–97.5, n=244) (p<0.001) for the provisional low-risk group and 65.1% (50.7–76.2, n=56) versus 82.9% (75.6–88.2, n=142) (p=0.008) for the provisional standard-risk group. Twelve patients with provisional low-risk ALL and MRD ≥1% on day 19 but negative MRD (<0.01%) on day 46 were treated for standard-risk ALL and had a 10-year event-free survival of 88.9% (43.3–98.4). For the 244 provisional low-risk patients, an MRD level of <1% on day 19 predicted a superior outcome, regardless of the MRD level on day 46. Among provisional standard-risk patients with MRD <1% on day 19, the 15 with persistent MRD on day 46 tended to have an inferior 10-year event-free survival compared with the 126 lacking detectable MRD (72.7% [42.5–88.8] versus 84.0% [76.3–89.4], p=0.06) after receiving the same post-remission treatment for standard-risk ALL. Among patients attaining MRD

  20. Non-specific low back pain in primary care in the Spanish National Health Service: a prospective study on clinical outcomes and determinants of management

    PubMed Central

    Kovacs, Francisco M; Fernández, Carmen; Cordero, Antonio; Muriel, Alfonso; González-Luján, Luis; Gil del Real, María Teresa

    2006-01-01

    Background The Spanish National Health Service is a universal and free health care system. Non-specific low back pain (LBP) is a prevalent disorder, generating large health and social costs. The objectives of this study were to describe its management in primary care, to assess patient characteristics that influence physicians' decisions, and to describe clinical outcome at 2 months. Methods A cross-sectional sample of 648 patients with non-specific low back pain was recruited by 75 physicians (out of 361 – 20.8%) working in 40 primary care centers in 10 of the 17 administrative regions in Spain, covering 693,026 out of the 40,499,792 inhabitants. Patients were assessed on the day they were recruited, and prospectively followed-up 14 and 60 days later. The principal patient characteristics that were analyzed were: sex, duration of the episode, history of LBP, working status, severity of LBP, leg pain and disability, and results of straight leg raising test. Descriptors of management were: performance of the straight leg raising test, ordering of diagnostic procedures, prescription of drug treatment, referral to physical therapy, rehabilitation or surgery, and granting of sick leave. Regression analysis was used to analyze the relationship between patients' baseline characteristics and physicians' management decisions. Only workers were included in the models on sick leave. Results Mean age (SD) of included patients was 46.5 (15.5) years, 367 (56.6%) were workers, and 338 (52.5%) were females. Median (25th–75th interquartile range) duration of pain when entering the study was 4 (2–10) days and only 28 patients (4.3%) had chronic low back pain. Diagnostic studies included plain radiographs in 43.1% of patients and CT or MRI scans in 18.8%. Drug medication was prescribed to 91.7% of patients, 19.1% were sent to physical therapy or rehabilitation, and 9.6% were referred to surgery. The main determinants of the clinical management were duration of the episode and

  1. Controlled, prospective, randomized, clinical evaluation of partial ceramic crowns inserted with RelyX Unicem with or without selective enamel etching. Results after 2 years.

    PubMed

    Schenke, Frederike; Federlin, Marianne; Hiller, Karl-Anton; Moder, Daniel; Schmalz, Gottfried

    2012-04-01

    Among the materials used for luting indirect restorations, growing interest has been directed towards the use of self-adhesive resin cements. The aim of this prospective randomized controlled clinical trial was to evaluate the clinical performance of the self-adhesive resin cement RelyX Unicem (RXU) for luting partial ceramic crowns (PCCs). In addition, the influence of selective enamel etching prior to luting (RXU+E) was assessed. Two-year results are reported. Thirty-four patients (68 PCCs) had originally received the intended treatment at baseline (BL). Twenty-nine patients (14 male, 15 female) with a total of 58 PCCs participated in the 2-year recall. In each patient, one PCC had been placed with RXU, one PCC with RXU+E. Restorations were evaluated at BL and 24 months after placement using modified United States Public Health Service criteria for postoperative hypersensitivity, anatomic form, marginal adaptation, marginal discoloration, surface texture and recurrent caries. Additionally, the "percentage failure" within the 2-year recall period for all restorations (n = 68) was calculated according to ADA Program Guidelines. Target value for acceptability of each procedure was <5% failure within 24 m. For statistical analysis of the data, the chi-square test was applied (α = 0.05). The median patient age was 41 years (24-59 years). Median PBI was 8% (5-10%). Twenty-two RXU PCCs were placed in molars, seven in premolars. Twenty-one RXU+E PCCs were placed in molars, eight in premolars. Statistically significant changes were observed for marginal adaptation (MA) and marginal discoloration (MD) between BL and 2 years but not between the two groups (RXU, RXU+E). Percentage of alfa values at BL for MA (RXU, 97% and RXU+E, 100%) and for MD (RXU, 97% and RXU+E, 97%) decreased to RXU, 14% and RXU+E, 28% for MA and to RXU, 50% and RXU+E, 59% for MD after 24 months. Within the observation period, three failures were recorded with RXU (5.1% failure), one

  2. A 4-Mb deletion in the region Xq27.3-q28 is associated with non-random inactivation of the non-mutant X chromosome

    SciTech Connect

    Clarke, J.T.R.; Han, L.P.; Michalickova, K.

    1994-09-01

    A girl with severe Hunter disease was found to have a submicroscopic deletion distrupting the IDS locus in the region Xq27.3-q28 together with non-random inactivation of the non-mutant X chromosome. Southern analysis of DNA from the parents and from hamster-patient somatic cell hybrids containing only the mutant X chromosome revealed that the deletion represented a de novo mutation involving the paternal X chromosome. Methylation-sensitive RFLP analysis of DNA from maternal fibroblasts and lymphocytes showed methylation patterns consistent with random X-inactivation, indicating that the non-random X-inactivation in the patient was not inherited and was likely a direct result of the Xq27.3-q28 deletion. A 15 kb EcoRI junction fragment, identified in patient DNA using IDS cDNA probes, was cloned from a size-selected patient DNA library. Clones containing the deletion junction were restriction mapped and fragments were subcloned and used to isolate normal sequence on either side of the deletion from normal X chromosome libraries. Comparison of the sequences from normal and mutant X chromosome clones straddling the deletion breakpoint showed that the mutation had occurred by recombination between Alu repeats. Screening of YAC contigs containing normal X chromosome sequence from the region of the mutation, using probes from either side of the deletion breakpoint, showed that the deletion was approximately 4 Mb in size. Probing of mutant DNA with 16 STSs distributed throughout the region of the deletion confirmed that the mutation is a simple deletion with no complex rearrangements of islands of retained DNA. A search for sequences at Xq27.3-q28 involved in X chromosome inactivation is in progress.

  3. Clinical significance of LAIR1 (CD305) as assessed by flow cytometry in a prospective series of patients with chronic lymphocytic leukemia

    PubMed Central

    Perbellini, Omar; Falisi, Erika; Giaretta, Ilaria; Boscaro, Elisa; Novella, Elisabetta; Facco, Monica; Fortuna, Stefania; Finotto, Silvia; Amati, Eliana; Maniscalco, Francesco; Montaldi, Anna; Alghisi, Alberta; Aprili, Fiorenza; Bonaldi, Laura; Paolini, Rossella; Scupoli, Maria Teresa; Trentin, Livio; Ambrosetti, Achille; Semenzato, Gianpietro; Pizzolo, Giovanni; Rodeghiero, Francesco; Visco, Carlo

    2014-01-01

    Most patients affected by chronic lymphocytic leukemia are diagnosed by flow cytometry. Several immunophenotypic markers have been identified as significant and independent prognostic variables, especially from retrospective cohorts. However, while attractive because their detection is inexpensive and feasible in most laboratories, only few have been validated by independent series. The expression of leukocyte-associated immunoglobulin-like receptor-1 (also known as LAIR1, LAIR-1 or CD305), an inhibitor of B-cell receptor-mediated signaling, has been reported to be lacking in high-risk chronic lymphocytic leukemia. However, its correlation with biological variables and its prognostic significance remain unknown. We investigated 311 consecutive patients, prospectively enrolled since 2007. Methods for studying patients were standardized and included clinical assessment, immunophenotype, fluorescence in situ hybridization, and status of immunoglobulin heavy chain variable region genes. Overall, 22.1% of patients had Binet stage B or C disease, 38.5% had unmutated immunoglobulin genes, 15.1% had high-risk cytogenetic abnormalities, 23.4% were CD38+, 37.8% CD49d+, and 59.8% LAIR1+. Expression of LAIR1 was inversely related to that of CD38 (P=0.0005), but was not associated with CD49d expression (P=0.96). A significantly lower expression of LAIR1 was observed in patients with Binet stage B or C disease (P=0.023), and in the presence of high-risk cytogenetic abnormalities (P=0.048) or unmutated immunoglobulin heavy chain variable region genes (P<0.0001). At univariate analysis LAIR1+ was significantly associated with longer time to first treatment (P=0.0002). This favorable effect of LAIR1+ was confirmed by multivariate analysis (hazard ratio=2.1, P=0.03 for LAIR1). Our results indicate that LAIR1 expression is a reliable and inexpensive marker capable of independently predicting time to first treatment in newly diagnosed unselected patients with chronic lymphocytic

  4. Prospective study on nanoparticle albumin-bound paclitaxel in advanced breast cancer: clinical results and biological observations in taxane-pretreated patients

    PubMed Central

    Fabi, Alessandra; Giannarelli, Diana; Malaguti, Paola; Ferretti, Gianluigi; Vari, Sabrina; Papaldo, Paola; Nisticò, Cecilia; Caterino, Mauro; De Vita, Roy; Mottolese, Marcella; Iacorossi, Laura; Cognetti, Francesco

    2015-01-01

    Background There is a deep need to improve the care of metastatic breast cancer (MBC) patients, since even today it remains an incurable disease. Taxanes are considered the most effective cytotoxic drugs for the treatment of MBC, both in monotherapy and in combined schedules, but the need for synthetic solvents contributes to the severe toxicities and may have a negative impact on the efficacy. Nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a colloidal suspension of paclitaxel and human serum albumin initially developed to avoid the toxicities associated with conventional taxanes. Patients and methods The aim of this prospective, single-center open-label, noncomparative study was to evaluate the efficacy and safety of nab-paclitaxel in MBC patients pretreated with taxanes. The patients were treated with nab-paclitaxel as a single agent, 260 mg/m2 on day 1 of each 3-week cycle or 125 mg/m2 weekly. The primary endpoint was the overall response rate (ORR). Secondary objectives were duration of response, clinical benefit rate, progression-free survival (PFS), overall survival, and safety. Results A total of 42 patients (median age 48 years, median Eastern Cooperative Oncology Group performance status 0, triple-negative MBC 19%, all pretreated with a taxane-based therapy, mainly in advanced disease) were enrolled in the study. The ORR was 23.8%, including one complete response (2.4%) and nine partial responses (21.4%); the disease control rate was 50%. The median duration of response was 7.2 months. After a median follow-up of 9 months, the median PFS was 4.6 months. ORR and PFS were similar irrespective of the previous chemotherapy lines, metastatic sites, and biomolecular expression. Nab-paclitaxel was well tolerated, and the most frequent treatment-related toxicities were mild to moderate (grades 1–2). Conclusion This real-life study shows that nab-paclitaxel has a significant antitumor activity and a manageable safety profile in patients pretreated with

  5. Diffusion-weighted MRI of breast lesions: a prospective clinical investigation of the quantitative imaging biomarker characteristics of reproducibility, repeatability, and diagnostic accuracy.

    PubMed

    Spick, Claudio; Bickel, Hubert; Pinker, Katja; Bernathova, Maria; Kapetas, Panagiotis; Woitek, Ramona; Clauser, Paola; Polanec, Stephan H; Rudas, Margaretha; Bartsch, Rupert; Helbich, Thomas H; Baltzer, Pascal A

    2016-10-01

    Diffusion-weighted MRI (DWI) provides insights into tissue microstructure by visualization and quantification of water diffusivity. Quantitative evaluation of the apparent diffusion coefficient (ADC) obtained from DWI has been proven helpful for differentiating between malignant and benign breast lesions, for cancer subtyping in breast cancer patients, and for prediction of response to neoadjuvant chemotherapy. However, to further establish DWI of breast lesions it is important to evaluate the quantitative imaging biomarker (QIB) characteristics of reproducibility, repeatability, and diagnostic accuracy. In this intra-individual prospective clinical study 40 consecutive patients with suspicious findings, scheduled for biopsy, underwent an identical 3T breast MRI protocol of the breast on two consecutive days (>24 h). Mean ADC of target lesions was assessed (two independent readers) in four separate sessions. Reproducibility, repeatability, and diagnostic accuracy between examinations (E1, E2), readers (R1, R2), and measurements (M1, M2) were assessed with intraclass correlation coefficients (ICCs), coefficients of variation (CVs), Bland-Altman plots, and receiver operating characteristic (ROC) analysis with calculation of the area under the ROC curve (AUC). The standard of reference was either histopathology (n = 38) or imaging follow-up of up to 24 months (n = 2). Eighty breast MRI examinations (median E1-E2, 2 ± 1.7 days, 95% confidence interval (CI) 1-2 days, range 1-11 days) in 40 patients (mean age 56, standard deviation (SD) ±14) were evaluated. In 55 target lesions (mean size 25.2 ± 20.8 (SD) mm, range 6-106 mm), mean ADC values were significantly (P < 0.0001) higher in benign (1.38, 95% CI 1.27-1.49 × 10(-3)  mm(2) /s) compared with malignant (0.86, 95% CI 0.81-0.91 × 10(-) (3)  mm(2) /s) lesions. Reproducibility and repeatability showed high agreement for repeated examinations, readers, and measurements (all ICCs >0.9, CVs 3

  6. Clinical Presentation, Etiology and Outcome of Infective Endocarditis in the 21st Century: The International Collaboration on Endocarditis-Prospective Cohort Study

    PubMed Central

    Murdoch, David R.; Corey, G. Ralph; Hoen, Bruno; Miró, José M.; Fowler, Vance G.; Bayer, Arnold S.; Karchmer, Adolf W.; Olaison, Lars; Pappas, Paul A.; Moreillon, Philippe; Chambers, Stephen T.; Chu, Vivian H.; Falcó, Vicenç; Holland, David J.; Jones, Philip; Klein, John L.; Raymond, Nigel J.; Read, Kerry M.; Tripodi, Marie Francoise; Utili, Riccardo; Wang, Andrew; Woods, Christopher W.; Cabell, Christopher H.

    2013-01-01

    Background The aim of this study was to provide a contemporary picture of the presentation, etiology and outcome of infective endocarditis (IE) in a large patient cohort from multiple locations worldwide. Methods Prospective cohort study of 2781 adults with definite IE admitted to 58 hospitals in 25 countries between June 2000 and September 2005. Results The median age of the cohort was 57.9 (IQR 43.2–71.8) years and 72% had native valve IE. Most (77%) patients presented early in the disease (<30 days) with few of the classic clinical hallmarks of IE. Recent health-care exposure was found in one quarter of patients. Staphylococcus aureus was the most common pathogen (31%). Mitral (41%) and aortic (38%) valves were infected most commonly. Complications were common: stroke (17%); embolization other than stroke (23%); heart failure (32%) and intracardiac abscess (14%). Surgical therapy was common (48%) and in-hospital mortality remained high (18%). Prosthetic valve involvement (OR 1.47, 95%CI 1.13–1.90), increasing age (OR 1.30, 95%CI 1.17–1.46 per 10-year interval), pulmonary edema (OR 1.79, 95%CI 1.39–2.30), S. aureus infection (OR 1.54, 95%CI 1.14–2.08), coagulase-negative staphylococcal infection (OR 1.50, 95%CI 1.07–2.10), mitral valve vegetation (OR 1.34, 95%CI 1.06–1.68), and paravalvular complications (OR 2.25, 95%CI 1.64–3.09) were associated with increased risk of in-hospital death, while viridans streptococcal infection (OR 0.52, 95%CI 0.33–0.81) and surgery (OR 0.61, 95%CI 0.44–0.83) were associated with decreased risk. Conclusions In the early 21st century, IE is more often an acute disease, characterized by a high rate of S. aureus infection. Mortality remains relatively high. PMID:19273776

  7. Biodiversity Prospecting.

    ERIC Educational Resources Information Center

    Sittenfeld, Ana; Lovejoy, Annie

    1994-01-01

    Examines the use of biodiversity prospecting as a method for tropical countries to value biodiversity and contribute to conservation upkeep costs. Discusses the first agreement between a public interest organization and pharmaceutical company for the extraction of plant and animal materials in Costa Rica. (LZ)

  8. Does school-based physical activity decrease overweight and obesity in children aged 6–9 years? A two-year non-randomized longitudinal intervention study in the Czech Republic

    PubMed Central

    2012-01-01

    Background Globally, efforts aimed at the prevention of childhood obesity have led to the implementation of a range of school-based interventions. This study assessed whether augmenting physical activity (PA) within the school setting resulted in increased daily PA and decreased overweight/obesity levels in 6-9-year-old children. Methods Across the first to third primary school years, PA of 84 girls and 92 boys was objectively monitored five times (each for seven successive days) using Yamax pedometer (step counts) and Caltrac accelerometer (activity energy expenditure AEE - kcal/kg per day). Four schools were selected to participate in the research (2 intervention, 2 controls), comprising intervention (43 girls, 45 boys) and control children (41 girls, 47 boys). The study was non-randomized and the intervention schools were selected on the basis of existing PA-conducive environment. Analyses of variance (ANOVA) for repeated measures examined the PA programme and gender effects on the step counts and AEE. Logistic regression (Enter method) determined the obesity and overweight occurrence prospect over the course of implementation of the PA intervention. Results There was a significant increase of school-based PA during schooldays in intervention children (from ≈ 1718 to ≈ 3247 steps per day; and from 2.1 to ≈ 3.6 Kcal/Kg per day) in comparison with the control children. Increased school-based PA of intervention children during schooldays contributed to them achieving >10,500 steps and >10.5 Kcal/Kg per school day across the 2 years of the study, and resulted in a stop of the decline in PA levels that is known to be associated with the increasing age of children. Increased school-based PA had also positive impact on leisure time PA of schooldays and on PA at weekends of intervention children. One year after the start of the PA intervention, the odds of being overweight or obese in the intervention children was almost three times lower than that of

  9. Metabolic effects of the contraceptive skin patch and subdermal contraceptive implant in Mexican women: A prospective study

    PubMed Central

    2014-01-01

    Background The contraceptive skin patch (CSP) accepted by the U.S. FDA in 2001 includes ethinylestradiol and norelgestromine, whereas the subdermal contraceptive implant (SCI) has etonogestrel and is also approved by the FDA. In Mexico, both are now widely used for contraceptio