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Sample records for prospective clinical pilot

  1. Clinical and radiographic evaluation of single tantalum dental implants: a prospective pilot clinical study

    PubMed Central

    DE FRANCESCO, M.; GOBBATO, E.A.; NOCE, D.; CAVALLARI, F.; FIORETTI, A.

    2016-01-01

    SUMMARY Objective The aim of this prospective pilot clinical case series report was to evaluate, through a clinical and radiographic analysis, the peri-implant bone resorption of the tantalum dental implants (TMT) (Zimmer TMT, Parsippany, NJ, USA) one year after prosthetic rehabilitation. Methods Twenty tantalum dental implants were placed in both maxillas and mandibles of 20 patients. Patients were asked to attend a radiographic and clinical follow-up and their previous clinical records and X-rays were assessed. Bone levels were calculated by digitally measuring the distance from the implant shoulder to the first bone-to-implant on periapical radiographs taken at surgery and after 6 and 12 months of functioning. The Pearson correlation analysis was performed to assess it there was a correlation between the measurement of the marginal bone loss (MBL). The Anova Test with a post-hoc analysis using Bonferroni’s test was used to compare the three group (0, 6 months and 12 months). Results The mean total MBL for the group 0 months was 0.84 mm (SD 0.21), 6 months was 0.87 mm (SD 0.22) and for 12 months was 0.89 mm (SD 0.23). The values of the Pearson’s coefficients showed that the data measurement were positively correlated. The Anova test showed a statistically significant difference between the groups. Conclusion The statistically significant difference in marginal bone loss can be considered physiological. Within the limits of this study it can be concluded that TMT implants have an excellent bone crest’s stability, however, to have most accurate information, will be necessary extend the sample. PMID:28280531

  2. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study

    PubMed Central

    2010-01-01

    Background Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients and methods Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Results Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. Conclusion IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy. PMID:20152024

  3. Birch pollen influence the severity of atopic eczema - prospective clinical cohort pilot study and ex vivo penetration study.

    PubMed

    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.

  4. 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

  5. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

    PubMed Central

    Joshi, Chaitanya Pradeep; Dani, Nitin Hemchandra; Khedkar, Smita Uday

    2016-01-01

    Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG) and beta-tricalcium phosphate (β-TCP) alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05). Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials. PMID:28298826

  6. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study

    PubMed Central

    Schumacher, Andrew; Sikov, William M.; Quesenberry, Matthew I.; Safran, Howard; Khurshid, Humera; Mitchell, Kristen M.

    2017-01-01

    Background Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. Methods We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. Results Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38). Conclusions Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient’s education level or cultural characteristics should be evaluated across socio-demographic groups. Trial registration Clinicaltrials.gov NCT01772511 PMID:28235011

  7. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial

    PubMed Central

    Henderson, John C.; Neradilek, Moni B.; Moyer, Nicolas A.; Ashcraft, Kristine C.; Thirumaran, Ranjit K.

    2017-01-01

    Background In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST) on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED) visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients. Methods and findings This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110) were randomized to pharmacogenetic profiling (n = 57). The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53) received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR), 0.65; 95% confidence interval (CI), 0.32–1.28; P = 0.21) and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27–0.82; P = 0.007). The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31–1.21; P = 0.16) and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34–0.99; P = 0.045). Differences in composite outcomes at

  8. Evaluation of atorvastatin efficacy and toxicity on spermatozoa, accessory glands and gonadal hormones of healthy men: a pilot prospective clinical trial

    PubMed Central

    2014-01-01

    Background Recommendations for cardiovascular disease prevention advocate lowering both cholesterol and low-density lipoprotein cholesterol systemic levels, notably by statin intake. However, statins are the subject of questions concerning their impact on male fertility. This study aimed to evaluate, by a prospective pilot assay, the efficacy and the toxicity of a decrease of cholesterol blood levels, induced by atorvastatin on semen quality and sexual hormone levels of healthy, normocholesterolaemic and normozoospermic men. Methods Atorvastatin (10 mg daily) was administrated orally during 5 months to 17 men with normal plasma lipid and standard semen parameters. Spermatozoa parameters, accessory gland markers, semen lipid levels and blood levels of gonadal hormones were assayed before statin intake, during the treatment, and 3 months after its withdrawal. Results Atorvastatin treatment significantly decreased circulating low-density lipoprotein cholesterol (LDL-C) and total cholesterol concentrations by 42% and 24% (p < 0.0001) respectively, and reached the efficacy objective of the protocol. During atorvastatin therapy and/or 3 months after its withdrawal numerous semen parameters were significantly modified, such as total number of spermatozoa (-31%, p < 0.05), vitality (-9.5%, p < 0.05), total motility (+7.5%, p < 0.05), morphology (head, neck and midpiece abnormalities, p < 0.05), and the kinetics of acrosome reaction (p < 0.05). Seminal concentrations of acid phosphatases (p < 0.01), α-glucosidase (p < 0.05) and L-carnitine (p < 0.05) were also decreased during the therapy, indicating an alteration of prostatic and epididymal functions. Moreover, we measured at least one altered semen parameter in 35% of the subjects during atorvastatin treatment, and in 65% of the subjects after withdrawal, which led us to consider that atorvastatin is unsafe in the context of our study. Conclusions Our results show for the first

  9. 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.

  10. A prospective pilot clinical trial evaluating the utility of a dynamic near-infrared imaging device for characterizing suspicious breast lesions

    PubMed Central

    Xu, Ronald X; Young, Donn C; Mao, Jimmy J; Povoski, Stephen P

    2007-01-01

    Introduction Characterizing and differentiating between malignant tumors, benign tumors, and normal breast tissue is increasingly important in the patient presenting with breast problems. Near-infrared diffuse optical imaging and spectroscopy is capable of measuring multiple physiologic parameters of biological tissue systems and may have clinical applications for assessing the development and progression of neoplastic processes, including breast cancer. The currently available application of near-infrared imaging technology for the breast, however, is compromised by low spatial resolution, tissue heterogeneity, and interpatient variation. Materials and methods We tested a dynamic near-infrared imaging schema for the characterization of suspicious breast lesions identified on diagnostic clinical ultrasound. A portable handheld near-infrared tissue imaging device (P-Scan; ViOptix Inc., Fremont, CA, USA) was utilized. An external mechanical compression force was applied to breast tissue. The tissue oxygen saturation and hemoglobin concentration were recorded simultaneously by the handheld near-infrared imaging device. Twelve categories of dynamic tissue parameters were derived based on real-time measurements of the tissue hemoglobin concentration and the oxygen saturation. Results Fifty suspicious breast lesions were evaluated in 48 patients. Statistical analyses were carried out on 36 out of 50 datasets that satisfied our inclusion criteria. Suspicious breast lesions identified on diagnostic clinical ultrasound had lower oxygenation and higher hemoglobin concentration than the surrounding normal breast tissue. Furthermore, histopathologic-proven malignant breast tumors had a lower differential hemoglobin contrast (that is, the difference of hemoglobin concentration variability between the suspicious breast lesion and the normal breast parenchyma located remotely elsewhere within the ipsilateral breast) as compared with histopathologic-proven benign breast lesions

  11. Clinical evaluation of the role of tulsi and turmeric in the management of oral submucous fibrosis: A pilot, prospective observational study

    PubMed Central

    Srivastava, Adit; Agarwal, Rahul; Chaturvedi, T. P.; Chandra, Akhilesh; Singh, O. P.

    2015-01-01

    The aim of the present study was to investigate the clinical efficacy of herbal medicines (1 gm tulsi and 1 gm turmeric mixed in glycerine base) for the treatment of oral submucous fibrosis (OSMF). Forty-one patients in the age group of 17- 56 years without any systemic complications were included in the study. The patients were treated with medicines, which were to be applied 3-4 times a day. Blood samples were collected before and after treatment to screen for any systemic changes due to these medications. Burning sensation and mouth opening were recorded before and after treatment. Patients were followed up on monthly subsequent visits for three months. Changes in the burning sensation on visual analogue scale (VAS) scale and difference in the mouth opening were analyzed statistically. A statistically significant improvement was seen in both burning sensation and mouth opening. Tulsi and turmeric offers a safe and efficacious combination of natural products available for symptomatic treatment of OSMF. PMID:25878464

  12. Prospective, randomized, open-label, pilot clinical trial comparing the effects of dexamethasone coadministered with diclofenac potassium or acetaminophen and diclofenac potassium monotherapy after third-molar extraction in adults

    PubMed Central

    Bamgbose, Babatunde Olamide; Akinwande, Jelili Adisa; Adeyemo, Wasiu Lanre; Ladeinde, Akinola Ladipo; Arotiba, Godwin Toyin; Ogunlewe, Mobolanle Olugbemiga

    2006-01-01

    Background: Patients who experience pain, swelling, and trismus after third-molar extraction are reported to experience a 3-fold higher rate of adverse effects (AEs) on quality of life compared with those who are asymptomatic after this surgery. Therefore, investigators emphasize the necessity for better control of this triad of sequelae. Steroids can reduce the risk for physiologic processes of inflammation, thereby suppressing the development of inflammation. Objective: The aim of this study was to compare the effects of dexamethasone 8 mg IM and diclofenac potassium (K) 50 mg PO, dexamethasone 8 mg IM and acetaminophen 1000 mg PO, and monotherapy with diclofenac K 50 mg PO on postoperative pain, swelling, and trismus after surgical removal of third molars. Methods: This prospective, randomized, open-label pilot study was conducted at the Department of Oral and Maxillofacial Surgery, Lagos University Teaching Hospital, Lagos, Nigeria. Patients were randomly allocated to 1 of 3 treatment groups: concomitant treatment with dexamethasone 8 mg IM and diclofenac K 50 mg PO or acetaminophen 1000 mg PO, or monotherapy with diclofenac K 50 mg PO. Overall analgesic efficacy of the drug combinations was assessed for 7 days postoperatively using a 4-point categorical pain-intensity rating scale (0 = no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain). Facial swelling was measured in 1 dimension on days 1, 2, and 7 after surgery using a tape measure placed from the tip of the tragus, to gonion, to the tip of the contralateral tragus, and trismus was assessed using interincisal mouth-opening ability, measured using a vernier-calibrated caliper on postoperative days 1, 2, and 7. Tolerability was assessed using direct questioning of the patients at follow-up visits. Results: A total of 150 patients (50 per treatment group) were included in the analysis (76 women, 74 men; mean [SD] age, 26.8 [5.04] years [range, 18–45 years]; 100% Nigerian). The proportion of

  13. Beliefs of Applied Studio Faculty on Desirable Traits of Prospective Music Education Majors: A Pilot Study

    ERIC Educational Resources Information Center

    Royston, Natalie Steele; Springer, D. Gregory

    2015-01-01

    The purpose of this pilot study was to examine the beliefs of applied music faculty on desirable traits of prospective music education majors. Researcher-designed surveys were sent electronically to applied music faculty at 12 National Association of Schools of Music-accredited institutions randomly selected from each of the four major divisions…

  14. Prospective markets and design concepts for civilian remotely piloted aircraft

    NASA Technical Reports Server (NTRS)

    Nelms, W. P., Jr.; Gregory, T. J.; Aderhold, J. R.

    1976-01-01

    This paper summarizes a study that examines the technical, economic, and environmental aspects of remotely piloted vehicles (RPVs) in the civil environment. A market survey was conducted in which 35 civil applications of RPVs were identified. For a number of these uses, vehicle and system concepts were defined, benefit and cost comparisons were made with present methods, and the influence of safety and environmental implications was assessed. The results suggest a sizable potential demand for the use of RPVs in the civil sector, and some of the applications show promising cost savings over established methods. A focussed technology effort could provide the safety assurances needed for routine civilian operation of RPVs.

  15. [Clinical dialysis: new problems and new prospects].

    PubMed

    Locatelli, F; Manzoni, C; Pozzoni, P; Pontoriero, G; Di Filippo, L

    2004-01-01

    The main problem nephrologists have to face today is the very high patient morbidity and mortality. A number of traditional and non-traditional risk factors have a role; among these anaemia, hypertension, dislipidemia, abnormalities in calcium-phosphate metabolism, hyperhomocysteinemia and endothelial dysfunction. An important innovation in the field of hemodialysis has been the availability of high-permeable and high-flux membranes, characterized by a high biocompatibility and ultrafiltration coefficient. The development of automatic systems to control ultrafiltration has enabled the utilisation of these membranes in the clinical setting (high-flux hemodialysis, hemofiltration, hemodiafiltration). It is common opinion that high-flux membranes can positively influence cardiovascular instability, but this has not been confirmed by clinical trials. Although preliminary data indicated a favorable effect on the correction of anemia in patients treated with high-permeable membranes, randomized trials have not shown a significant effect. Better control of anemia could be possible by means of on-line treatments, given their higher removal of medium- and large molecules and reduced microbiological and pyrogenic contamination of the dialysate. A number of analyses showed a lower incidence of bone cysts and/or carpal tunnel syndrome in patients treated with high-flux membranes compared to low-flux ones. High-flux treatments could reduce morbidity and mortality in hemodialysis patients. However, despite its large sample size, the HEMO Study has not been capable of showing a statistically significant effect of higher dialysis dose and high-flux membranes on survival and morbidity. The MPO study has been expressively designed to do a prospective evaluation of the long-term effect of membrane permeability on clinical outcomes. These results are greatly awaited.

  16. 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

  17. Sleep attacks and antiparkinsonian drugs: a pilot prospective pharmacoepidemiologic study.

    PubMed

    Montastruc, J L; Brefel-Courbon, C; Senard, J M; Bagheri, H; Ferreira, J; Rascol, O; Lapeyre-Mestre, M

    2001-01-01

    A prospective survey was performed to characterize the prevalence of sleep attacks and to evaluate precipitating factors in a group of 236 patients with idiopathic Parkinson's disease. Sleep attacks were reported by 72 patients (30.5%). Multivariate analysis showed a marked association between the occurrence of sudden sleep episodes and first autonomic failure, followed by treatment with ropinirole and bromocriptine. The present work underlines the major contributing role of autonomic failure followed by dopamine agonists in the occurrence of such an event. Because a relationship between sleep attacks and not only ropinirole but also bromocriptine treatment was described, the present work suggests that sleep attacks are a common side effect of all dopamine agonists.

  18. Nursing Students' Clinical Experience With Death: A Pilot Study.

    PubMed

    Heise, Barbara A; Gilpin, Laura C

    2016-01-01

    Although debriefing in simulation settings is routine in nursing education, debriefing does not routinely take place in clinical settings with nursing students after a patient has died. This pilot study sought to explore nursing students' perceptions of their first experience with the death of a patient. Students reported emotional distress and feelings of inadequacy with regard to communicating with and supporting the family of the dying patient. Only half the students sampled reported debriefing by their clinical instructor or staff. Nurse educators must include debriefing and student support following a patient death in the clinical setting.

  19. Electronic brachytherapy for superficial and nodular basal cell carcinoma: a report of two prospective pilot trials using different doses

    PubMed Central

    Pons-Llanas, Olga; Candela-Juan, Cristian; Celada-Álvarez, Francisco Javier; Barker, Christopher A.; Tormo-Micó, Alejandro; Pérez-Calatayud, Jose; Botella-Estrada, Rafael

    2016-01-01

    Purpose Basal cell carcinoma (BCC) is a very common cancer in the Caucasian population. Treatment aims to eradicate the tumor with the lowest possible functional and aesthetic impact. Electronic brachytherapy (EBT) is a treatment technique currently emerging. This study aims to show the outcomes of two consecutive prospective pilot clinical trials using different radiation doses of EBT with Esteya® EB system for the treatment of superficial and nodular basal cell carcinoma. Material and methods Two prospective, single-center, non-randomized, pilot studies were conducted. Twenty patients were treated in each study with different doses. The first group (1) was treated with 36.6 Gy in 6 fractions of 6.1 Gy, and the second group (2) with 42 Gy in 6 fractions of 7 Gy. Cure rate, acute toxicity, and late toxicity related to cosmesis were analyzed in the two treatment groups. Results In group 1, a complete response in 90% of cases was observed at the first year of follow-up, whereas in group 2, the complete response was 95%. The differences with reference to acute toxicity and the cosmetic results between the two treatment groups were not statistically significant. Conclusions Our initial experience with Esteya® EB system to treat superficial and nodular BCC shows that a dose of 36.6 Gy and 42 Gy delivered in 6 fraction of 7 Gy achieves a 90% and 95% clinical cure rate at 1 year, respectively. Both groups had a tolerable toxicity and a very good cosmesis. The role of EBT in the treatment of BCC is still to be defined. It will probably become an established option for selected patients in the near future. PMID:26985197

  20. Prospects and strategies for clinical tolerance.

    PubMed

    Monaco, A P

    2004-01-01

    The morbidity and mortality associated with chronic immunosuppression provide a strong motivation for development of clinical tolerance. This paper discusses the definition(s) of clinical (operational) tolerance, the role of chimerism in experimental and clinical tolerance, and the special role of bone marrow in tolerance induction. The states of microchimerism and macrochimerism are defined and related to certain clinical observations in solid organ transplantation. Current clinical strategies already being tested in the clinic are briefly reviewed. Certain principles for induction of clinical (operational) tolerance are elaborated.

  1. Prospective pilot trial of PerMIT versus standard anticoagulation service management of patients initiating oral anticoagulation.

    PubMed

    Borgman, Mark P; Pendleton, Robert C; McMillin, Gwendolyn A; Reynolds, Kristen K; Vazquez, Sara; Freeman, Andrew; Wilson, Andrew; Valdes, Roland; Linder, Mark W

    2012-09-01

    We performed a randomised pilot trial of PerMIT, a novel decision support tool for genotype-based warfarin initiation and maintenance dosing, to assess its efficacy for improving warfarin management. We prospectively studied 26 subjects to compare PerMIT-guided management with routine anticoagulation service management. CYP2C9 and VKORC1 genotype results for 13 subjects randomly assigned to the PerMIT arm were recorded within 24 hours of enrolment. To aid in INR interpretation, PerMIT calculates estimated loading and maintenance doses based on a patient's genetic and clinical characteristics and displays calculated S-warfarin plasma concentrations based on planned or administered dosages. In comparison to control subjects, patients in the PerMIT study arm demonstrated a 3.6-day decrease in the time to reach a stabilised INR within the target therapeutic range (4.7 vs. 8.3 days, p = 0.015); a 12.8% increase in time spent within the therapeutic interval over the first 25 days of therapy (64.3% vs. 55.3%, p = 0.180); and a 32.9% decrease in the frequency of warfarin dose adjustments per INR measurement (38.3% vs. 57.1%, p = 0.007). Serial measurements of plasma S-warfarin concentrations were also obtained to prospectively evaluate the accuracy of the pharmacokinetic model during induction therapy. The PerMIT S-warfarin plasma concentration model estimated 62.8% of concentrations within 0.15 mg/l. These pilot data suggest that the PerMIT method and its incorporation of genotype/phenotype information may help practitioners increase the safety, efficacy, and efficiency of warfarin therapeutic management.

  2. Enhancing Patient Safety Using Clinical Nursing Data: A Pilot Study.

    PubMed

    Choi, Jeeyae; Choi, Jeungok E

    2016-01-01

    To enhance patient safety from falls, many hospital information systems have been implemented to collect clinical data from the bedside and have used the information to improve fall prevention care. However, most of them use administrative data not clinical nursing data. This necessitated the development of a web-based Nursing Practice and Research Information Management System (NPRIMS) that processes clinical nursing data to measure nurses' delivery of fall prevention care and its impact on patient outcomes. This pilot study developed computer algorithms based on a falls prevention protocol and programmed the prototype NPRIMS. It successfully measured the performance of nursing care delivered and its impact on patient outcomes using clinical nursing data from the study site. Results of the study revealed that NPRIMS has the potential to pinpoint components of nursing processes that are in need of improvement for preventing patient from falls.

  3. Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

    PubMed Central

    Ricart, Elena; Esteve, Maria; Andreu, Montserrat; Casellas, Francesc; Monfort, David; Sans, Miquel; Oudovenko, Natalia; Lafuente, Raúl; Panés, Julián

    2007-01-01

    AIM: To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis. METHODS: In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption. RESULTS: Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and 11 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases. Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported. CONCLUSION: Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect. PMID:17465500

  4. Piloting Augmented Reality Technology to Enhance Realism in Clinical Simulation.

    PubMed

    Vaughn, Jacqueline; Lister, Michael; Shaw, Ryan J

    2016-09-01

    We describe a pilot study that incorporated an innovative hybrid simulation designed to increase the perception of realism in a high-fidelity simulation. Prelicensure students (N = 12) cared for a manikin in a simulation lab scenario wearing Google Glass, a wearable head device that projected video into the students' field of vision. Students reported that the simulation gave them confidence that they were developing skills and knowledge to perform necessary tasks in a clinical setting and that they met the learning objectives of the simulation. The video combined visual images and cues seen in a real patient and created a sense of realism the manikin alone could not provide.

  5. Integrating service excellence in a CHF clinical pathway pilot project.

    PubMed

    Hahn, Joyce; Bishop, Geri; Fennell, Lenora

    2002-01-01

    The complex dynamics of the current healthcare environment require healthcare delivery systems to become cost effective and quality driven. Educated healthcare consumers expect superior service and timely responses to their needs. For one healthcare system, customer expectations were an integral part of designing, implementing, and measuring the service components of congestive heart failure pathway outcomes. Service excellence can influence overall clinical outcomes when measured by consumer awareness and patient satisfaction. The inclusion of service excellence as an intrinsic piece of the organizational strategic plan laid the groundwork for this integrated pilot project.

  6. [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.

  7. 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

  8. Clinical evidence for Japanese population based on prospective studies--linking clinical trials and clinical practice.

    PubMed

    Ogawa, Hisao; Kojima, Sunao

    2009-10-01

    "Evidence-based medicine (EBM)" implies effective and high quality practice for patients based on well-grounded medical science. The success of clinical trials in Japan is essential to build original evidence specific for Japanese patients. Based on this concept, we have performed several large-scale clinical trials to provide EBM, including the Japanese Antiplatelets Myocardial Infarction Study [JAMIS; clinical improvement in acute myocardial infarction (AMI) patients with antiplatelet therapy], the Japanese beta-Blockers and Calcium Antagonists Myocardial Infarction (JBCMI; comparison of the effects of beta-blockers and calcium antagonists on cardiovascular events in post-AMI patients), a multicenter study for aggressive lipid-lowering strategy by HMG-CoA reductase inhibitors in patients with AMI (MUSASHI; effects of statin therapy on cardiovascular events in patients with AMI), and the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD trial; efficacy of low-dose aspirin therapy for primary prevention of atherosclerotic events in type 2 diabetic patients). The results of these prospective studies were directly linked with clinical practice. We have acquired the know-how of large-scale clinical trials; an important point is to have passion for "buildup evidence specific for the Japanese" and to recruit subjects for enrollment after explaining the significance of "clinical trials for the Japanese".

  9. Does an education intervention improve physician signature legibility? Pilot study of a prospective chart review.

    PubMed

    Glisson, James K; Morton, Mary E; Bond, Allyn H; Griswold, Michael

    2011-01-01

    Illegible physician signatures in patient records can lead to inaccurate documentation, improper billing, and potential legal issues. Many studies in the current literature address legibility of prescriptions and medication orders; however, few focus on legibility of physicians' signatures. The purpose of the present quality improvement survey was to evaluate physician signature legibility on patient charts at the University of Mississippi Medical Center's Adult Internal Medicine Clinic. At the time of the study, the clinic was known as the University of Mississippi Medical Center (UMMC) Adult Internal Medicine Clinic. Effective July 1, 2009, UMMC entered into a collaboration with Jackson-Hinds Comprehensive Health Center (JHCHC), a federally qualified health center. The clinic is now known as the Federally Qualified Health Center at the Jackson Medical Mall. In this pilot study, we examined clinic notes and billing sheets for legible physician signatures over a three-month period. Midway through the study, an intervention group was given name stamps and a standardized discussion on the importance of signature legibility and proper name stamp usage. Legibility of resident signatures in the intervention group increased from 26 percent to 60 percent. Legibility of attending signatures in the intervention group increased from 1.4 percent to 86 percent. Results suggest the significant impact of resident education on changing practice behavior.

  10. Asenapine for the Control of Physical Aggression: A Prospective Naturalist Pilot Study

    PubMed Central

    Amon, Jin Shi; Johnson, Sarah B.; El-Mallakh, Rif S.

    2017-01-01

    It has been previously purported that higher relative affinity to the dopamine D4 receptor compared to D2 (i.e., D4/D2 affinity ratio > 1) may underlie unique antiaggression potency. Asenapine is a newer antipsychotic that also has D4/D2 affinity ratio > 1. It has demonstrated efficacy in reducing acute agitation in a placebo-controlled study. We performed a prospective naturalistic, pilot, proof of concept study on an inpatient psychiatric unit. Among patients with aggression at time of admission (≥ 12 on Refined Aggression Questionnaire [RAQ], or ≥ 2 on Modified Overt Aggression Scale [MOAS]), asenapine treatment was associated with a significant reduction in total aggression as measured by the MOAS (−14.7 ± 11.59 vs. −5.4 ± 10.12, P = 0.045), and particularly physical aggression (−8.0 ± 5.06 vs. −0.78 ± 2.40, P < 0.0001) compared to treatment that did not include asenapine. These data suggest that asenapine may be useful in the targeted treatment of aggression, and provide some support for the D4/D2 affinity ratio hypothesis. PMID:28138201

  11. Proteomic analysis of field cancerization in pharynx and oesophagus: a prospective pilot study.

    PubMed

    Roesch-Ely, Mariana; Leipold, Alexandra; Nees, Matthias; Holzinger, Dana; Dietz, Andreas; Flechtenmacher, Christa; Wolf, Thomas; Zapatka, Marc; Bosch, Franz X

    2010-08-01

    'Field cancerization' in head and neck squamous cell carcinoma (HNSCC) is poorly understood and it may extend from the pharynx into the oesophagus. Both local recurrences and second primary carcinomas/second field tumours may originate from field cancerization. Our prospective pilot study aimed at the identification of patients suffering from field cancerization on the basis of mucosal protein profiles. Five mucosal biopsies from the oropharynx, hypopharynx and from three regions of the oesophagus were taken from 24 patients. Protein profiles were generated from the mucosal biopsies. After classifier learning, using the profiles of the patients without tumour diagnosis (n = 9), we were able to discriminate between the different mucosal sites and between healthy mucosa and HNSCC using tumour and healthy tissue samples. Mucosal biopsies of tumour patients (n = 15) revealed changes in the protein profiles similar to those in the tumours. During 42 months median follow-up, six tumour patients experienced local recurrences and second field tumours, of which three occurred in the oesophagus. In all six cases, tumour relapse was correctly predicted by altered mucosal protein profiles (p = 0.007, Fisher's exact test, two-tailed). Consequently, molecular field cancerization had a strong impact on progression-free survival (p = 0.007, log-rank test). Protein profiles of small diagnostic biopsies hold great promise to improve personalized risk assessment in HNSCC. Larger studies are needed to further substantiate these findings.

  12. Adherence of Irish general practitioners to European guidelines for acute low back pain: a prospective pilot study.

    PubMed

    Fullen, Brona M; Maher, Thomas; Bury, Gerard; Tynan, Aodan; Daly, Leslie E; Hurley, Deirdre A

    2007-08-01

    There are no national low back pain (LBP) clinical guidelines in Ireland, and neither the level of adherence of General Practitioners (GPs) to the European guidelines, nor the cost of LBP to the patient and the state, have been investigated. A prospective pilot study was conducted on 54 consenting patients (18M, 36F: mean age (SD): 40.5 (14.3) years) with a new episode of acute LBP (<3 months) attending one of nine participating GPs. Baseline demographic, LBP classification [i.e. simple back ache (SBA), nerve root pain (NRP), serious spinal pathology (SSP)] and primary care management data were recorded over a three month period. Adherence and costs were estimated based on: medication prescription, referral for investigations, treatment or consultations, and wage replacement costs (time signed off work). For both SBA and NRP, medication prescriptions were consistent with European guideline recommendations, but not for referral for further treatment (39% of SBA patients were referred on first visit), secondary care (54% of NRP patients were referred on first visit), or discontinuation of work (50% NRP patients on first GP visit). The average total cost (direct and wage replacement) for a single episode of LBP over 12 weeks was 20,531 Euros (20,300-20,762). Direct costs accounted for 43% [8874.36 Euros, (8643.37-9105.37 Euros)] and wage replacement costs 57% (11,657 Euros). In conclusion, management of acute LBP in a cohort of GPs in Ireland was not consistent with European clinical guideline recommendations, and warrants higher levels of postgraduate education among GPs, as well as restructuring of primary care services, which should improve patient outcome and reduce costs.

  13. [Study and prospects for clinical diseases treated with scraping therapy].

    PubMed

    Wang, Ying-ying; Yang, Jin-sheng

    2009-02-01

    In order to explore characteristics of clinical diseases treated by scraping therapy, summarize laws of clinical application of scraping therapy, and prospect for research direction of scraping therapy in future, collect 437 articles about scraping therapy between 1994-2007 and analyze and summarize the treated diseases and methods of scraping therapy. Results indicate that scraping therapy has been widely applied to commonly encountered diseases and frequently encountered diseases in departments of internal medicine, surgery, gynecology and pediatrics, etc. with more obvious therapeutic effects. Clinically, it can combine with acupuncture and moxibustion, cupping, massage, blood-letting puncture and other methods. In future, the studies on standardization of manipulation and standards for assessment of therapeutic effect, suitable diseases and the mechanisms of scraping therapy, and development of tools and media, etc. of scraping therapy should be strengthened.

  14. 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.

  15. Prioritization strategies in clinical practice guidelines development: a pilot study

    PubMed Central

    2010-01-01

    Objective Few methodological studies address the prioritization of clinical topics for the development of Clinical Practice Guidelines (CPGs). The aim of this study was to validate a methodology for Priority Determination of Topics (PDT) of CPGs. Methods and results Firstly, we developed an instrument for PDT with 41 criteria that were grouped under 10 domains, based on a comprehensive systematic search. Secondly, we performed a survey of stakeholders involved in CPGs development, and end users of guidelines, using the instrument. Thirdly, a pilot testing of the PDT procedure was performed in order to choose 10 guideline topics among 34 proposed projects; using a multi-criteria analysis approach, we validated a mechanism that followed five stages: determination of the composition of groups, item/domain scoring, weights determination, quality of the information used to support judgments, and finally, topic selection. Participants first scored the importance of each domain, after which four different weighting procedures were calculated (including the survey results). The process of weighting was determined by correlating the data between them. We also reported the quality of evidence used for PDT. Finally, we provided a qualitative analysis of the process. The main domains used to support judgement, having higher quality scores and weightings, were feasibility, disease burden, implementation and information needs. Other important domains such as user preferences, adverse events, potential for health promotion, social effects, and economic impact had lower relevance for clinicians. Criteria for prioritization were mainly judged through professional experience, while good quality information was only used in 15% of cases. Conclusion The main advantages of the proposed methodology are supported by the use of a systematic approach to identify, score and weight guideline topics selection, limiting or exposing the influence of personal biases. However, the methodology was

  16. Use of the SONET score to evaluate Urgent Care Center overcrowding: a prospective pilot study

    PubMed Central

    Wang, Hao; Robinson, Richard D; Cowden, Chad D; Gorman, Violet A; Cook, Christopher D; Gicheru, Eugene K; Schrader, Chet D; Jayswal, Rani D; Zenarosa, Nestor R

    2015-01-01

    Objectives To derive a tool to determine Urgent Care Center (UCC) crowding and investigate the association between different levels of UCC overcrowding and negative patient care outcomes. Design Prospective pilot study. Setting Single centre study in the USA. Participants 3565 patients who registered at UCC during the 21-day study period were included. Patients who had no overcrowding statuses estimated due to incomplete collection of operational variables at the time of registration were excluded in this study. 3139 patients were enrolled in the final data analysis. Primary and secondary outcome measures A crowding estimation tool (SONET: Severely overcrowded, Overcrowded and Not overcrowded Estimation Tool) was derived using the linear regression analysis. The average length of stay (LOS) in UCC patients and the number of left without being seen (LWBS) patients were calculated and compared under the three different levels of UCC crowding. Results Four independent operational variables could affect the UCC overcrowding score including the total number of patients, the number of results pending for patients, the number of patients in the waiting room and the longest time a patient was stationed in the waiting room. In addition, UCC overcrowding was associated with longer average LOS (not overcrowded: 133±76 min, overcrowded: 169±79 min, and severely overcrowded: 196±87 min, p<0.001) and an increased number of LWBS patients (not overcrowded: 0.28±0.69 patients, overcrowded: 0.64±0.98, and severely overcrowded: 1.00±0.97). Conclusions The overcrowding estimation tool (SONET) derived in this study might be used to determine different levels of crowding in a high volume UCC setting. It also showed that UCC overcrowding might be associated with negative patient care outcomes. PMID:25872940

  17. Metronomic therapy with oral 6-mercaptopurine in elderly acute myeloid leukemia: A prospective pilot study

    PubMed Central

    Kapoor, Akhil; Beniwal, Surender Kumar; Kalwar, Ashok; Singhal, Mukesh Kumar; Nirban, Raj Kumar; Kumar, Harvindra Singh

    2016-01-01

    Introduction: Acute myeloid leukemia (AML) in elderly patients differs biologically from that in younger patients and is known to have unfavorable chromosomal rearrangements, higher resistance, and lower tolerance to chemotherapy. In such circumstances, instead of giving full-blown chemotherapy, palliative metronomic chemotherapy (MCT) could be a treatment option. Patients and Methods: We performed a prospective pilot study of old AML patients (age >60 years) not amenable to curative treatment. Thirty-two patients were enrolled into the study and were treated with daily oral 6-mercaptopurine 75 mg/m2. The following inclusion criteria were used: age >60 years, nonpromyelocytic AML, the absence of uncontrolled comorbidities, and patient not amenable to curative treatment. Overall survival (OS) was calculated using Kaplan–Meier method and Cox regression analysis were used to calculate the hazards ratio of significant factors. Results: The median age of the patients was 69 years (range: 61–86 years) with male: female ratio of 2.5:1. About 59.4% of patients had Eastern Cooperative Oncology Group performance status of 2 while rest had the status of 3. The median OS was 6 months (95% confidence interval [CI]: 4.4–7.6). Males had median OS of 7 months (95% CI: 5.4–8.6) versus females with OS of 3 months (95% CI: 1.5–4.4; P = 0.008). There was no survival difference on the basis of baseline hemoglobin or French-American-British class. There were no Grade 4 toxicities and no episode of febrile neutropenia. Conclusions: MCT with oral 6-mercaptopurine is an attractive treatment option in elderly AML patients who are not amenable to curative therapy with minimal toxicities. PMID:27275453

  18. Early Intervention Following Trauma May Mitigate Genetic Risk for PTSD in Civilians: A Pilot Prospective Emergency Department Study

    PubMed Central

    Rothbaum, Barbara O.; Kearns, Megan C.; Reiser, Emily; Davis, Jennifer S.; Kerley, Kimberly A.; Rothbaum, Alex O.; Mercer, Kristina B.; Price, Matthew; Houry, Debra; Ressler, Kerry J.

    2015-01-01

    intervention group, even after controlling for age, sex, race, education, income, and childhood trauma. Using logistic regression, the number of risk alleles was significantly associated with likelihood of PTSD diagnosis at week 12 (P < .05). Conclusions This pilot prospective study suggests that combined genetic variants may serve to predict those most at risk for developing PTSD following trauma. A psychotherapeutic intervention initiated in the emergency department within hours of the trauma may mitigate this risk. The role of genetic predictors of risk and resilience should be further evaluated in larger, prospective intervention and prevention trials. Trial Registration ClinicalTrials.gov identifier: NCT00895518 PMID:25188543

  19. 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.

  20. 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

  1. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study

    PubMed Central

    Kollmann, Martina; Aldrian, Lisa; Scheuchenegger, Anna; Mautner, Eva; Herzog, Sereina A.; Urlesberger, Berndt; Raggam, Reinhard B.; Lang, Uwe; Obermayer-Pietsch, Barbara; Klaritsch, Philipp

    2017-01-01

    Objective Early bonding by skin-to-skin contact (SSC) has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC) after cesarean section on neonatal adaptation, maternal pain and stress response. Study design This prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria) between September 2013 and January 2014. Women were randomly assigned to intraoperative (“early”) SCC (n = 17) versus postoperative (“late”) SCC (n = 18). Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature), maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase. Results There was no evidence for differences in parameters reflecting neonatal transition or stress response between the ‘Early SSC Group’ and the ‘Late SSC Group’. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’ (p = 0.004). Conclusions This study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’, which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial. Trial

  2. Clinical Impact of Sample Interference on Intensive Insulin Therapy in Severely Burned Patients: A Pilot Study

    PubMed Central

    Tran, Nam K.; Godwin, Zachary R.; Bockhold, Jennifer C.; Passerini, Anthony G.; Cheng, Julian; Ingemason, Morgan

    2013-01-01

    Objective Severely burned patients benefit from intensive insulin therapy (IIT) for tight glycemic control (TGC). We evaluated the clinical impact of automatic correction of hematocrit and ascorbic acid interference for bedside glucose monitoring performance in critically ill burn patients. Methods The performance of two point-of-care glucose monitoring systems (GMS): (a) GMS1, an autocorrecting device, and (b) GMS2, a non-correcting device were compared. Sixty remnant arterial blood samples were collected in a prospective observational study to evaluate hematocrit and ascorbic acid effects on GMS1 vs. GMS2 accuracy paired against a plasma glucose reference. Next we enrolled 12 patients in a pilot randomized controlled trial (RCT). Patients were randomized 1:1 to receive IIT targeting a TGC interval of 111–151 mg/dL and guided by either GMS1 or GMS2. GMS bias, mean insulin rate, and glycemic variability were calculated. Results In the prospective study, GMS1 results were similar to plasma glucose results (mean bias: −0.75[4.0] mg/dL, n=60, P=0.214). GMS2 results significantly differed from paired plasma glucose results (mean bias: −5.66[18.7] mg/dL, n=60, P=0.048). Ascorbic acid therapy elicited significant GMS2 performance bias (29.2[27.2], P<0.001). RCT results reported lower mean bias (P<0.001), glycemic variability (P<0.05), mean insulin rate (P<0.001), and frequency of hypoglycemia (P<0.001) in the GMS1 group than the GMS2 group. Conclusions Anemia and high dose ascorbic acid therapy negatively impact GMS accuracy and TGC in burn patients. Automatic correction of confounding factors improves glycemic control. Further studies are warranted to determine outcomes associated with accurate glucose monitoring during IIT. PMID:23884048

  3. Pilot study of hemoglobinopathies in newborns of the Rafael Calvo maternity clinic of Cartagena, Colombia

    PubMed Central

    Barboza, Miriam; Viola, Maricela; Moneriz, Carlos; Araque, Luz Marina

    2012-01-01

    Introduction: The hemoglobinopathies are a heterogeneous group of congenital anemias from Africa, Asia and the Mediterranean. Due to the migration of this population have spread worldwide, especially in Latin America and the Caribbean region, which Cartagena de Indias is included, with a large proportion of people of African descent. The lack of routine programs that include an appropriate methodology for precise identification of those affected and carriers, impossible to know the real behavior of this disease in our country and an early and appropriate to the patients before the disease manifests itself and produce its serious consequences. Objective: To estimate the incidence and describe the epidemiological profile of hemoglobinopathies in newborns Rafael Calvo Maternity Clinic of Cartagena, in the period from January to June 2010. Methods: Prospective descriptive study of a population of 1,729 newborns. Samples were collected cord blood on filter paper. Isoelectric focusing electrophoresis (IEF )was used to separate the haemoglobins. Results: 94.4% (1,633 samples) were normal (hemoglobin FA), 4.5% (78 samples) were heterozygous for haemoglobin S (HbFAS), 1% (17samples) were heterozygous for haemoglobin C (hemoglobin FAC) and 0.1% (1 sample) was double heterozygous SC (hemoglobin FSC). Conclusion: Due to the high incidence of hemoglobinopathies found in this pilot study highlights the importance and necessity of establishing an obligatory neonatal screening in the city of Cartagena, in order to make a timely diagnosis and monitoring of affected and carrier. PMID:24893191

  4. Prospective genotyping of Mycobacterium tuberculosis from fresh clinical samples.

    PubMed

    Bidovec-Stojkovič, Urška; Seme, Katja; Žolnir-Dovč, Manca; Supply, Philip

    2014-01-01

    Shorter time-to-result is key for improving molecular-guided epidemiological investigation of tuberculosis (TB) cases. We performed a prospective study to evaluate the use of standardized MIRU-VNTR (mycobacterial interspersed repetitive-unit-variable-number tandem-repeat) typing of Mycobacterium tuberculosis directly on 79 fresh clinical samples from 26 TB patients consecutively enrolled over a 17-month period. Overall, complete 24-locus types were obtained for 18 out of the 26 (69.2%) patients and 14 of the 16 grade 3+ and grade 2+ samples (87.5%). The degree of completion of the genotypes obtained significantly correlated with smear microscopy grade both for 26 first samples (p = 0.0003) and for 53 follow-up samples (p = 0.002). For 20 of the 26 patients for whom complete or even incomplete M. tuberculosis isolate genotypes were obtained, typing applied to the clinical samples allowed the same unambiguous conclusions regarding case clustering or uniqueness as those that could have been drawn based on the corresponding cultured isolates. Standard 24 locus MIRU-VNTR typing of M. tuberculosis can be applied directly to fresh clinical samples, with typeability depending on the bacterial load in the sample.

  5. Impact of the European clinical trials directive on prospective academic clinical trials associated with BMT.

    PubMed

    Frewer, L J; Coles, D; van der Lans, I A; Schroeder, D; Champion, K; Apperley, J F

    2011-03-01

    The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.

  6. 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

  7. Diagnosing epilepsy in neurology clinics: a prospective study.

    PubMed

    Angus-Leppan, Heather

    2008-07-01

    The certainty of the initial diagnosis of epilepsy was assessed prospectively by one neurologist in outpatients. One hundred and fifty-eight consecutive referrals with loss of consciousness or possible epilepsy were seen. The relative contributions to the initial diagnosis from the referral letter, history taking in clinic, physical examination, and investigation were compared. There was a referring diagnosis in 28.5%. The neurologist reached a diagnosis in 87% of the 158 cases: in 43% epilepsy, 25% syncope, 12% non-epileptic seizures and in 7% other diagnoses. There was a low correlation between referral and specialist diagnosis. Physical examination did not change the diagnosis in any patient. Investigations changed the diagnosis in one patient. Neuro-imaging revealed a relevant abnormality in 12/43 (27.9%) scanned. The yield from EEG was 7/25 (28%), but the EEG changed the diagnosis in only one case. Cardiac testing confirmed the type of syncope in 2/47 (4.3%) of patients. Blood tests did not contribute to the diagnosis in any patient. The neurology consultation significantly increased diagnostic certainty. The diagnosis of epilepsy remains largely clinical. It is important that patients are aware of this prior to investigation.

  8. Comparison of Alpha Blockers in Treatment of Premature Ejaculation: A Pilot Clinical Trial

    PubMed Central

    Akin, Yigit; Gulmez, Hakan; Ates, Mutlu; Bozkurt, Aliseydi; Nuhoglu, Baris

    2013-01-01

    Background: Premature ejaculation (PE) is the most common sexual disorder in men and studies reported prevalence up to 30% (1, 2). PE is not a life-threatening medical condition but it influences the quality of life (QoL). Objectives: The aim of this study was to compare the efficiency, and safety of alpha blocker drugs in the treatment of patients with premature ejaculation (PE). Additionally we investigated the quality of life (QoL) in patients with PE who were treated with alpha blocker drugs. Materials and Methods: This study was a pilot clinical trial. Prospectively documented 108 patients with PE were treated and were followed-up in urology outpatient clinic. All patients were divided into 5 groups according to used alpha blocker agents which were determined by simple randomization. Silodosin 4mg (Group 1, n = 21), tamsulosin hydrochloride 0.4mg (Group 2, n = 23), alfuzosin 10mg (Group 3, n = 22), terazosin 5mg (Group 4, n = 21), doksazosin mesylate 4mg (Group5, n = 21), were used for treatment. The demographic parameters of patients, pre and post treatment intravaginal ejaculation latency time (IELT), PE Profile (PEP), and QoL index were recorded and evaluated. Effectiveness of treatment was evaluated by measuring IELT. Additionally, side effects of drugs were recorded. P < 0.05 was considered statistically significant. Results: All alpha blocker drugs were statistically effective for preventing PE. Notably, silodosin seemed to be more effective for preventing PE than other alpha blockers (P < 0.05). However all alpha blockers provided development in QoL scores, silodosin was a little better than other drugs in statistical analyses. Furthermore statistical increase in IELT and decrease in PEP were provided more in Group 1 than other groups (P < 0.05). Conclusions: Silodosin seems to be able to even more prevent PE. Silodosin may provide development in QoL than other alpha blocker agents. Additionally, lower systemic adverse events and more effectivity are

  9. Children's Views Matter Too! A Pilot Project Assessing Children's and Adolescents' Experiences of Clinical Psychology Services

    ERIC Educational Resources Information Center

    Gordon, Michael; Russo, Kate

    2009-01-01

    This pilot study explored the experiences and understanding of clinical psychology practices and services of children and adolescents attending clinical psychology outpatient appointments. Fifteen young participants took part in the study. A content analysis indicated that young children and adolescents have an appropriate understanding of the…

  10. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    PubMed

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  11. 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

  12. 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

  13. Monitoring Central Venous Catheter Resistance to Predict Imminent Occlusion: A Prospective Pilot Study

    PubMed Central

    Wolf, Joshua; Tang, Li; Rubnitz, Jeffrey E.; Brennan, Rachel C.; Shook, David R.; Stokes, Dennis C.; Monagle, Paul; Curtis, Nigel; Worth, Leon J.; Allison, Kim; Sun, Yilun; Flynn, Patricia M.

    2015-01-01

    Background Long-term central venous catheters are essential for the management of chronic medical conditions, including childhood cancer. Catheter occlusion is associated with an increased risk of subsequent complications, including bloodstream infection, venous thrombosis, and catheter fracture. Therefore, predicting and pre-emptively treating occlusions should prevent complications, but no method for predicting such occlusions has been developed. Methods We conducted a prospective trial to determine the feasibility, acceptability, and efficacy of catheter-resistance monitoring, a novel approach to predicting central venous catheter occlusion in pediatric patients. Participants who had tunneled catheters and were receiving treatment for cancer or undergoing hematopoietic stem cell transplantation underwent weekly catheter-resistance monitoring for up to 12 weeks. Resistance was assessed by measuring the inline pressure at multiple flow-rates via a syringe pump system fitted with a pressure-sensing transducer. When turbulent flow through the device was evident, resistance was not estimated, and the result was noted as “non-laminar.” Results Ten patients attended 113 catheter-resistance monitoring visits. Elevated catheter resistance (>8.8% increase) was strongly associated with the subsequent development of acute catheter occlusion within 10 days (odds ratio = 6.2; 95% confidence interval, 1.8–21.5; p <0.01; sensitivity, 75%; specificity, 67%). A combined prediction model comprising either change in resistance greater than 8.8% or a non-laminar result predicted subsequent occlusion (odds ratio = 6.8; 95% confidence interval, 2.0–22.8; p = 0.002; sensitivity, 80%; specificity, 63%). Participants rated catheter-resistance monitoring as highly acceptable. Conclusions In this pediatric hematology and oncology population, catheter-resistance monitoring is feasible, acceptable, and predicts imminent catheter occlusion. Larger studies are required to validate

  14. Prospects for pilot plants based on the tokamak, spherical tokamak and stellarator

    NASA Astrophysics Data System (ADS)

    Menard, J. E.; Bromberg, L.; Brown, T.; Burgess, T.; Dix, D.; El-Guebaly, L.; Gerrity, T.; Goldston, R. J.; Hawryluk, R. J.; Kastner, R.; Kessel, C.; Malang, S.; Minervini, J.; Neilson, G. H.; Neumeyer, C. L.; Prager, S.; Sawan, M.; Sheffield, J.; Sternlieb, A.; Waganer, L.; Whyte, D.; Zarnstorff, M.

    2011-10-01

    A potentially attractive next-step towards fusion commercialization is a pilot plant, i.e. a device ultimately capable of small net electricity production in as compact a facility as possible and in a configuration scalable to a full-size power plant. A key capability for a pilot-plant programme is the production of high neutron fluence enabling fusion nuclear science and technology (FNST) research. It is found that for physics and technology assumptions between those assumed for ITER and nth-of-a-kind fusion power plant, it is possible to provide FNST-relevant neutron wall loading in pilot devices. Thus, it may be possible to utilize a single facility to perform FNST research utilizing reactor-relevant plasma, blanket, coil and auxiliary systems and maintenance schemes while also targeting net electricity production. In this paper three configurations for a pilot plant are considered: the advanced tokamak, spherical tokamak and compact stellarator. A range of configuration issues is considered including: radial build and blanket design, magnet systems, maintenance schemes, tritium consumption and self-sufficiency, physics scenarios and a brief assessment of research needs for the configurations.

  15. Homeopathic Secretin in autism: a clinical pilot study.

    PubMed

    Robinson, T W

    2001-04-01

    Autism is a condition characterised by impairments of social communication, social interaction and social imagination. The exact aetiology of autism is unknown but some autistic features have been explained by the 'opioid excess theory' in which excess brain peptide levels have a morphine-like activity. Reduction of peptide levels by administration of the duodenal enzyme Secretin has been found to improve social and language skills in autistic patients. Homeopathic Secretin has been said to produce similar effects. A pilot study was undertaken to study these effects by administration of Secretin to a group of autistic patients. Weekly assessment for 12 weeks was performed by the patients' care workers. Statistical analysis of the mean pre-treatment results compared with the mean treatment results suggested a worsening in the autistic symptoms during treatment. Discussion with the care workers revealed changes and some improvements that were not recordable on the scoring system. Further research into Secretin treatment of autism using a more detailed and customized scoring system would be justified. Following this pilot study a randomised controlled trial of Secretin vs placebo would be appropriate.

  16. Radioembolization with 90Y glass microspheres for the treatment of unresectable metastatic liver disease from chemotherapy-refractory gastrointestinal cancers: final report of a prospective pilot study

    PubMed Central

    Kerlan, Robert K.; Hawkins, Randall A.; Pampaloni, Miguel; Taylor, Andrew G.; Kohi, Maureen P.; Kolli, K. Pallav; Atreya, Chloe E.; Bergsland, Emily K.; Kelley, R. Kate; Ko, Andrew H.; Korn, W. Michael; Van Loon, Katherine; McWhirter, Ryan M.; Luan, Jennifer; Johanson, Curt; Venook, Alan P.

    2016-01-01

    Background This prospective pilot single-institution study was undertaken to document the feasibility, safety, and efficacy of radioembolization of liver-dominant metastatic gastrointestinal cancer using 90Y glass microspheres. Methods Between June 2010 and October 2013, 42 adult patients (26 men, 16 women; median age 60 years) with metastatic chemotherapy-refractory unresectable colorectal (n=21), neuroendocrine (n=11), intrahepatic bile duct (n=7), pancreas (n=2), and esophageal (n=1) carcinomas underwent 60 lobar or segmental administrations of 90Y glass microspheres. Data regarding clinical and laboratory adverse events (AE) were collected prospectively for up to 5.5 years after radioembolization. Radiographic responses were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Time to maximum response, response duration, progression-free survival (PFS) (hepatic and extrahepatic), and overall survival (OS) were measured. Results Median target dose and activity were 109.4 Gy and 2.6 GBq per treatment session, respectively. Majority of clinical AE were grade 1 or 2 in severity. Patients with colorectal cancer had hepatic objective response rate (ORR) of 25% and a hepatic disease control rate (DCR) of 80%. Median PFS and OS were 1.0 and 4.4 months, respectively. Patients with neuroendocrine tumors (NET) had hepatic ORR and DCR of 73% and 100%, respectively. Median PFS was 8.9 months for this cohort. DCR and median PFS and OS for patients with cholangiocarcinoma were 86%, 1.1 months, and 6.7 months, respectively. Conclusions 90Y glass microspheres device has a favorable safety profile, and achieved prolonged disease control of hepatic tumor burden in a subset of patients, including all patients enrolled in the neuroendocrine cohort. PMID:28078110

  17. 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

  18. Pilot Clinical Application of an Adaptive Robotic System for Young Children with Autism

    ERIC Educational Resources Information Center

    Bekele, Esubalew; Crittendon, Julie A.; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E.

    2014-01-01

    It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small…

  19. An Occupation and Participation Approach to Reading Intervention (OPARI) Part II: Pilot Clinical Application

    ERIC Educational Resources Information Center

    Grajo, Lenin C.; Candler, Catherine

    2016-01-01

    The Occupation and Participation Approach to Reading Intervention (OPARI) is an intervention approach for children with reading difficulties that emphasizes reading as an important occupation of children. Part I presented the theoretical basis of the OPARI. Part II describes a pilot clinical application of the OPARI. Guided by Schkade and…

  20. A Pilot Study of the Challenges and Prospects of Continuous Assessment Implementation in Nigeria

    ERIC Educational Resources Information Center

    Owolabi, Henry O.; Onuka, Adams O. U.

    2010-01-01

    This study obtained basic information from teachers and students on the challenges and prospects of implementing continuous assessment (CA) in the Nigerian school system. Secondary Schools in Ilorin, the capital city of Kwara State, located in the central region of Nigeria were sampled for use in the study. It employed survey research design…

  1. Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study

    PubMed Central

    2014-01-01

    Background Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. Methods We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show “O”. Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. Results The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. Conclusion A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology. PMID:24920527

  2. Postoperative Albumin Drop Is a Marker for Surgical Stress and a Predictor for Clinical Outcome: A Pilot Study

    PubMed Central

    Hübner, Martin; Mantziari, Styliani; Demartines, Nicolas; Pralong, François; Coti-Bertrand, Pauline; Schäfer, Markus

    2016-01-01

    Background. Surgical stress during major surgery may be related to adverse clinical outcomes and early quantification of stress response would be useful to allow prompt interventions. The aim of this study was to evaluate the acute phase protein albumin in the context of the postoperative stress response. Methods. This prospective pilot study included 70 patients undergoing frequent abdominal procedures of different magnitude. Albumin (Alb) and C-reactive protein (CRP) levels were measured once daily starting the day before surgery until postoperative day (POD) 5. Maximal Alb decrease (Alb Δ min) was correlated with clinical parameters of surgical stress, postoperative complications, and length of stay. Results. Albumin values dropped immediately after surgery by about 10 g/L (42.2 ± 4.5 g/L preoperatively versus 33.8 ± 5.3 g/L at day 1, P < 0.001). Alb Δ min was correlated with operation length (Pearson ρ = 0.470, P < 0.001), estimated blood loss (ρ = 0.605, P < 0.001), and maximal CRP values (ρ = 0.391, P = 0.002). Alb Δ min levels were significantly higher in patients having complications (10.0 ± 5.4 versus 6.1 ± 5.2, P = 0.005) and a longer hospital stay (ρ = 0.285, P < 0.020). Conclusion. Early postoperative albumin drop appeared to reflect the magnitude of surgical trauma and was correlated with adverse clinical outcomes. Its promising role as early marker for stress response deserves further prospective evaluation. PMID:26880899

  3. 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…

  4. An Exploration of Prospective Teachers' Learning of Clinical Interview Techniques

    ERIC Educational Resources Information Center

    Groth, Randall E.; Bergner, Jennifer A.; Burgess, Claudia R.

    2016-01-01

    The present study followed four prospective teachers through the process of learning to interview during an undergraduate research project experience. Participants conducted and video recorded a series of interviews with children. They also carried out guided analyses of the videos and written artefacts from the interviews to formulate conjectures…

  5. Feasibility of NOTES Omental Plug Repair of Perforated Peptic Ulcers – Results from a Clinical Pilot Trial

    PubMed Central

    Bingener, Juliane; Loomis, Erica A.; Gostout, Christopher J.; Zielinski, Martin D.; Buttar, Navtej S.; Wong Kee Song, Louis M.; Baron, Todd H.; Ghahfarokhi, Leili Shahgholi; Rajan, Elizabeth

    2013-01-01

    Background Ulcer perforation carries up to a 30% 1-year mortality rate. Intervention-related adverse events are among statistically significant predictors of 1-year mortality. A Natural Orifice Transluminal Endoscopic Surgical (NOTES) approach may be less invasive and may decrease procedure-related adverse events by diminishing the "second hit", thus leading to decreased morbidity and mortality. Aim To assess the feasibility of an endoscopic transluminal omental plug technique in patients with perforated gastroduodenal ulcers under laparoscopic guidance. Methods Patients with suspected acute gastroduodenal ulcer perforations were offered participation in this prospective pilot study. Closure of the perforation was attempted using NOTES omental plug technique. Demographic, clinical, endoscopic and radiographic data were abstracted, as well as morbidity, mortality and pilot data regarding quality of life (QOL). Results From February 2010 through Feb 2012, 17 patients presented to a tertiary care center with clinically suspected perforated ulcer. Of seven patients (mean age 79, range 64–89) who consented to the study, three underwent the study procedure. All patients had multiple comorbidities. Two patients presented with 4–6 mm perforated peptic ulcers and underwent successful laparoscopic-assisted NOTES omental and falciform ligament patch closure, respectively. Postoperative radiographic contrast studies showed no leak and patients were discharged home on postoperative days 3 and 4. The third patient had undergone enterocutaneous fistula repair with herniorrhaphy 6 weeks prior; a transluminal endoscopic approach was feasible; however, the omentum was under too much tension to be secured. This procedure was converted to an open omental patch repair. For all but one consented patient, obtaining QOL data was feasible. Conclusion Initial results from a laparoscopic-assisted NOTES approach for closure of perforated peptic ulcers appear promising and enable swift

  6. Pilot Study of a Clinical Pathway Implementation in Rectal Cancer

    PubMed Central

    Uña, Esther; López-Lara, Francisco

    2010-01-01

    Background: Rectal cancer is a highly prevalent disease which needs a multidisciplinary approach to be treated. The absence of specific protocols implies a significant and unjustifiable variability among the different professionals involved in this disease. The purpose is to develop a clinical pathway based on the analysis process and aims to reduce this variability and to reduce unnecessary costs. Methods: We created a multidisciplinary team with contributors from every clinical area involved in the diagnosis and treatment in this disease. We held periodic meetings to agree on a protocol based on the best available clinical practice guidelines. Once we had agreed on the protocol, we implemented its use as a standard in our institution. Every patient older than 18 years who was diagnosed with rectal cancer was considered a candidate to be treated via the pathway. Results: We evaluated 48 patients during the course of this study. Every parameter measured was improved after the implementation of the pathway, except the proportion of patients with 12 nodes or more analysed. The perception that our patients had about this project was very good. Conclusions: Clinical pathways are needed to improve the quality of health care. This kind of project helps reduce hospital costs and optimizes the use of limited resources. On the other hand, unexplained variability is also reduced, with consequent benefits for the patients. PMID:21151842

  7. Prospective areas for development of biomedical technologies for a piloted Martian mission

    NASA Astrophysics Data System (ADS)

    Grigoriev, A. I.; Kozlovskaya, I. B.; Potapov, A. N.

    2006-07-01

    The presentation deals with the advance biomedical technologies that could be employed in a piloted mission to Mars. The idea is to use the experience of building up and utilization of orbital biomedical support systems (BMS) strengthened substantially by introduction of up-to-date technologies and equipment. Martian BMS will require development of technologies unknown in the near-Earth's orbits (artificial gravity, production greenhouse, wastes transformation). Much hope is laid on information technologies, automation of medical procedures, and telemedicine. On the phase of medical crew selection and during the mission medical examination, diagnostics and treatment should be performed with the use of advanced technologies sprung out of the discoveries of molecular biology, genomics, proteomics, and other disciplines of the modern science.

  8. 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…

  9. Clinic-based intervention to promote literacy. A pilot study.

    PubMed

    Needlman, R; Fried, L E; Morley, D S; Taylor, S; Zuckerman, B

    1991-08-01

    Educational research has shown that children become literate more easily if their parents read to them. A clinic-based program was designed to encourage early book use among parents of children at risk. It included (1) waiting room readers, (2) guidance about literacy development, and (3) provision of children's books at each visit. Seventy-nine parents of children aged 6 to 60 months were interviewed. Parents who had previously received a book were more likely to report looking at books with their children or that looking at books was a favorite activity (adjusted odds ratio, 4.05). This association was strongest among parents receiving Aid to Families With Dependent Children (odds ratio, 7.8). This preliminary study suggests that pediatricians can play a role in enriching children's early literacy environments, especially for children at high risk of school failure.

  10. Prospective pilot trial of dexmedetomidine sedation for awake diagnostic flexible bronchoscopy.

    PubMed

    Lee, Keat; Orme, Ruari; Williams, Daryl; Segal, Reny

    2010-10-01

    Dexmedetomidine has the favorable properties of sedation, sympatholysis, analgesia, and a low risk of apnea. These properties suggest that dexmedetomidine may be useful in procedural sedation. In view of this, we conducted a pilot trial to determine the feasibility of using dexmedetomidine as a sole agent for providing sedation during awake diagnostic flexible bronchoscopy. Patients presenting for awake diagnostic flexible bronchoscopy consented to participate in a trial of dexmedetomidine sedation for the procedure. In addition to local anesthetic topicalization of the airways, dexmedetomidine was infused at 0.5 μg/kg over 10 minutes followed by an infusion of 0.2 to 0.7 μg/kg/h titrating to a Ramsay Sedation Scale score of 3. Hemodynamic parameters (heart rate, blood pressure), oxygenation status (pulse oximetry), adverse events, use of rescue sedation, and patient and proceduralist satisfaction were recorded during the trial. Five of 9 recruited patients required rescue sedation to allow the procedure to proceed. Dexmedetomidine as a sole agent at an infusion of 0.5 μg/kg over 10 minutes followed by an infusion of 0.2 to 0.7 μg/kg/h is unable to provide adequate sedation for awake diagnostic flexible bronchoscopy without the need for rescue sedation in a large proportion of patients.

  11. Standardized diaper care regimen: a prospective, randomized pilot study on skin barrier function and epidermal IL-1α in newborns.

    PubMed

    Garcia Bartels, Natalie; Massoudy, Lida; Scheufele, Ramona; Dietz, Ekkehart; Proquitté, Hans; Wauer, Roland; Bertin, Christiane; Serrano, José; Blume-Peytavi, Ulrike

    2012-01-01

    Adaptation of skin barrier function and interleukin-1α (IL-1α) content in diapered and nondiapered skin are poorly characterized in newborns receiving standard skin care. In a monocentric, prospective pilot study 44 healthy, full-term neonates were randomly assigned to skin care with baby wipes (n = 21) or water-moistened washcloth (n = 23) at each diaper change. Transepidermal water loss (TEWL), skin hydration, skin-pH, IL-1α, and epidermal desquamation were measured on days 2, 14, and 28 postpartum. Microbiological colonization was evaluated at baseline and on day 28. Significantly lower TEWL was found on the buttock in the group using baby wipes compared to water. IL-1α and skin hydration significantly increased and pH decreased independent of skin care regimen. IL-1α was significantly higher in diapered skin compared to nondiapered skin. Although skin care with wipes seems to stabilize TEWL better than using water, the skin condition and microbiological colonization were comparable using both cleansing procedures. Increase of epidermal IL-1α may reflect postnatal skin barrier maturation. These data suggest that neither of the two cleansing procedures harms skin barrier maturation within the first four weeks postpartum. Longer observations on larger populations could provide more insight into postnatal skin barrier maturation.

  12. Reliability of solar keratosis clinical diagnosis: A prospective study.

    PubMed

    Buinauskaite, Evelina; Makstiene, Jurgita; Buinauskiene, Jurate; Valiukeviciene, Skaidra

    2015-05-01

    Usually solar keratoses (SK) are diagnosed clinically. However other diseases may clinically present as erythematous macules, papules or patches on sun-exposed areas; therefore the histopathology remains the gold standard diagnostic tool. Our study, which assessed the efficacy of photodynamic therapy (PDT), showed that one in 20 clinically diagnosed SK lesions grade I-II identified by board-certified dermatologists were rosacea and only one in 40 were malignant lesions. These findings should be considered by clinicians who treat clinically diagnosed grade I-II SK without response to treatment or diagnose the recurrence of SK after PDT.

  13. Validation of a virtual preoperative evaluation clinic: a pilot study.

    PubMed

    Zetterman, Corey V; Sweitzer, Bobbie J; Webb, Brad; Barak-Bernhagen, Mary A; Boedeker, Ben H

    2011-01-01

    Patients scheduled for surgery at the Omaha VA Medical Center were evaluated preoperatively via telemedicine. Following the examination, patients filled out a 15 item, 5 point Likert scale questionnaire regarding their opinion of preoperative evaluation in a VTC format. Evaluations were performed under the direction of nationally recognized guidelines and recommendations of experts in the field of perioperative medicine and were overseen by a staff anesthesiologist from the Omaha VA Medical Center. No significant difficulties were encountered by the patient or the evaluator regarding the quality of the audio/visual capabilities of the VTC link and its ability to facilitate preoperative evaluation. 87.5% of patients felt that virtual evaluation would save them travel time; 87.5% felt virtual evaluation could save them money; 7.3% felt uncomfortable using the VTC link; 12.2% felt the virtual evaluation took longer than expected; 70.7% preferred to be evaluated via VTC link; 21.9% were undecided; 9.7% felt they would rather be evaluated face-to-face with 26.8% undecided; 85.0% felt that teleconsultation was as good as being seen at the Omaha surgical evaluation unit; 7.5% were undecided. Our study has shown that effective preoperative evaluation can be performed using a virtual preoperative evaluation clinic; patients are receptive to the VTC format and, in the majority of cases, prefer it to face-to-face evaluation.

  14. A clinical forensic scientist in the burns unit: necessity or not? A prospective clinical study.

    PubMed

    Yasti, Ahmet Cinar; Tumer, Ali Riza; Atli, Mesut; Tutuncu, Tanju; Derinoz, Ali; Kama, Nuri Aydin

    2006-02-01

    Child abuse by burning is a common means of assault that may be difficult to prove. Even though well trained in burns management physicians on the burn team may not be sufficiently qualified to clarify the medicolegal aspects of the incident. In Turkey, physicians have a responsibility to notify the law offices of injury to children caused by any non-accidental mechanism including neglect. The consequences of false positive and/or false negative reports to the legal offices may be damaging for the care-takers and/or the children. In our study, 239 consecutively hospitalized children with burns were studied prospectively. A clinical forensic scientist and a physician of the burns team interpreted incidents separately so that neither had an idea about the other's diagnoses until the end of the study. There were found to be some differences in the interpretation of the incidents by the clinical forensic scientist and the burns team physician. These differences were described as discordant diagnoses. The physician accepted 99 (41.4%) of the incidents as an accident while only 66 (27.6%) of the victims were labelled as accidents by the forensic scientist. A multivariate analysis identified low socioeconomic status, aged between 3 and 6 years, and a family size of more than six as independent variables significantly associated with discordant diagnoses (p = 0.0388, 0.0001, 0.0203, respectively). As a conclusion, we suggest that to minimize the likelihood of a legally inaccurate diagnosis, a clinical forensic scientist seems to be necessary in the emergency department.

  15. Assessing research impact in academic clinical medicine: a study using Research Excellence Framework pilot impact indicators

    PubMed Central

    2012-01-01

    Background Funders of medical research the world over are increasingly seeking, in research assessment, to complement traditional output measures of scientific publications with more outcome-based indicators of societal and economic impact. In the United Kingdom, the Higher Education Funding Council for England (HEFCE) developed proposals for the Research Excellence Framework (REF) to allocate public research funding to higher education institutions, inter alia, on the basis of the social and economic impact of their research. In 2010, it conducted a pilot exercise to test these proposals and refine impact indicators and criteria. Methods The impact indicators proposed in the 2010 REF impact pilot exercise are critically reviewed and appraised using insights from the relevant literature and empirical data collected for the University of Oxford’s REF pilot submission in clinical medicine. The empirical data were gathered from existing administrative sources and an online administrative survey carried out by the university’s Medical Sciences Division among 289 clinical medicine faculty members (48.1% response rate). Results The feasibility and scope of measuring research impact in clinical medicine in a given university are assessed. Twenty impact indicators from seven categories proposed by HEFCE are presented; their strengths and limitations are discussed using insights from the relevant biomedical and research policy literature. Conclusions While the 2010 pilot exercise has confirmed that the majority of the proposed indicators have some validity, there are significant challenges in operationalising and measuring these indicators reliably, as well as in comparing evidence of research impact across different cases in a standardised manner. It is suggested that the public funding agencies, medical research charities, universities, and the wider medical research community work together to develop more robust methodologies for capturing and describing impact

  16. [Prospects of cytomedines application in clinical medicine and gerontology].

    PubMed

    Morozov, V G; Khavinson, V Kh

    2000-01-01

    Available are the results of experimental and clinical study of a new class of peptide bioregulators--cytomedines. Mechanism of action of these substances is considered. Cytomedines-based drugs can be used for prevention and treatment of age pathology and premature aging. A new trend in clinical medicine--bioregulation therapy--is grounded.

  17. A Pilot Evaluation of Portfolios for Quality Attestation of Clinical Ethics Consultants.

    PubMed

    Fins, Joseph J; Kodish, Eric; Cohn, Felicia; Danis, Marion; Derse, Arthur R; Dubler, Nancy Neveloff; Goulden, Barbara; Kuczewski, Mark; Mercer, Mary Beth; Pearlman, Robert A; Smith, Martin L; Tarzian, Anita; Youngner, Stuart J

    2016-01-01

    Although clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems, progress in developing standards for quality is challenging. In this article, we describe the results of a pilot project utilizing portfolios as an evaluation tool. We found that this approach is feasible and resulted in a reasonably wide distribution of scores among the 23 submitted portfolios that we evaluated. We discuss limitations and implications of these results, and suggest that this is a significant step on the pathway to an eventual certification process for clinical ethics consultants.

  18. Prospective Swiss pilot study of Endocuff-assisted colonoscopy in a screening population

    PubMed Central

    Sawatzki, Mikael; Meyenberger, Christa; Marbet, Urs Albert; Haarer, Johannes; Frei, Remus

    2015-01-01

    Background and study aims: The adenoma detection rate (ADR) is one of the quality measures in screening colonoscopy and is crucial for reducing colorectal cancer morbidity and mortality. Up to 25 % of adenomas are missed during colonoscopy. Endocuff is an easy-to-use device that is attached like a cap to the distal tip of the colonoscope in order to optimize visualization behind the folds of the colon and increase the ADR. This is the first prospective study of Endocuff-assisted colonoscopy (EC) in a screening population with follow-up to determine the ADR and adverse events of EC. Patients and methods: We prospectively enrolled asymptomatic patients referred for screening colonoscopy during the 4-month study period. We documented the Boston Bowel Preparation Scale (BBPS) score, cecal intubation rate, polyp detection rate, ADR, number of advanced adenomas, and number of adverse events. Colonoscopies were performed by five board-certified gastroenterologists. During follow-up, the patients were called 4 to 12 weeks after EC. Results: A total of 104 EC procedures were performed. Cecal intubation was achieved in 99 % of the patients, with a median intubation time of 6 minutes. The polyp detection rate and ADR in our study were 72 % and 47 %, respectively, and 13.5 % of the lesions were advanced adenomas. A significant number of adenomas were detected in the right side of the colon. Considering all the adenomas and hyperplastic polyps above the sigmoid, we recommended that nearly 60 % of our patients repeat an endoscopic follow-up according to the existing Swiss guidelines. We noted no perforations or other serious adverse events, even in the patients with extensive diverticulosis. Conclusions: EC is feasible with the most commonly available colonoscopes without severe adverse events. EC seems to be a safe and effective device for increasing the ADR, including small adenomas in the right side of the colon. Therefore, this technique may be recommended in the

  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. Vestibular rehabilitation in elderly patients with central vestibular dysfunction: a prospective, randomized pilot study.

    PubMed

    Marioni, Gino; Fermo, Salvatore; Lionello, Marco; Fasanaro, Elena; Giacomelli, Luciano; Zanon, Stefania; Staffieri, Claudia; Dall'Igna, Franco; Manzato, Enzo; Staffieri, Alberto

    2013-12-01

    For the vestibular system, aging is associated with degenerated otoconia and loss of hair cells, vestibular afferents, and cells in the vestibular nuclei. Further neurodegenerative processes involve cortical, extrapyramidal motor, and cerebellar structures. Dizziness is quite common in the elderly, limiting their mobility and activities. The role of vestibular rehabilitation in these patients is controversial. The present prospective, randomized, preliminary investigation aimed to compare the effect of a 6-week posturography-assisted vestibular rehabilitation protocol (30 min a week) combined with a home-based exercise program (group A, 14 randomly assigned elderly patients) with the same home-based exercise program alone (group B, 14 randomly assigned elderly patients) for treating dizziness due to central vestibular dysfunction in elderly patients. The outcomes were analyzed using the 25-item Dizziness Handicap Inventory (DHI) and computerized posturography. After rehabilitation, group A scored significantly better in the DHI for the functional (p = 0.0016) and emotional (p = 0.01) domains and total score (p = 0.001); only the emotional domain improved significantly in group B (p = 0.038). Group A improved significantly in some posturographic parameters in the motor tests (reaction time, movement velocity, and endpoint excursion), while group B experienced more limited improvements. Our preliminary results with a program of posturography-assisted vestibular rehabilitation, and home-based exercises are more promising than with home-based exercises alone. A new study on a larger series of elderly patients with central vestibular dysfunctions is currently underway at Padova University, considering the effect of a protocol involving rehabilitation with computerized posturography alone and the relationship between outcomes and the duration of rehabilitation programs.

  1. Regenerating matrix-based therapy for chronic wound healing: a prospective within-subject pilot study.

    PubMed

    Groah, Suzanne L; Libin, Alexander; Spungen, Miriam; Nguyen, Kim-Loan; Woods, Earthaleen; Nabili, Marjan; Ramella-Roman, Jessica; Barritault, Denis

    2011-02-01

    The aim of this study was to determine whether a skin-specific bioengineered regenerating agent (RGTA) heparan sulphate mimetic (CACIPLIQ20) improves chronic wound healing. The design of this article is a prospective within-subject study. The setting was an urban hospital. Patients were 16 African-American individuals (mean age 42 years) with 22 wounds (mean duration 2.5 years) because of either pressure, diabetic, vascular or burn wounds. Two participants each were lost to follow-up or removed because of poor compliance, resulting in 18 wounds analysed. Sterile gauze was soaked with CACIPLIQ20 saline solution, placed on the wound for 5 min, then removed twice weekly for 4 weeks. Wounds were otherwise treated according to the standard of care. Twenty-two percent of wounds fully healed during the treatment period. Wounds showed a 15.2-18.1% decrease in wound size as measured by the vision engineering research group (VERG) digital wound measurement system and total PUSH scores, respectively, at 4 weeks (P = 0.014 and P = 0.003). At 8 weeks there was an 18-26% reduction in wound size (P = 0.04) in the remaining patients. Wound-related pain measured by the visual analogue pain scale and the wound pain scale declined 60% (P = 0.024) and 70% (P = 0.001), respectively. Patient and clinician satisfaction remained positive throughout the treatment period. It is concluded that treatment with CACIPLIQ20 significantly improved wound-related pain and may facilitate wound healing. Patient and clinician satisfaction remained high throughout the trial.

  2. Prospective open-label clinical trial of trihexyphenidyl in children with secondary dystonia due to cerebral palsy.

    PubMed

    Sanger, Terence D; Bastian, Amy; Brunstrom, Jan; Damiano, Diane; Delgado, Mauricio; Dure, Leon; Gaebler-Spira, Deborah; Hoon, Alec; Mink, Jonathan W; Sherman-Levine, Sara; Welty, Leah J

    2007-05-01

    Although trihexyphenidyl is used clinically to treat both primary and secondary dystonia in children, limited evidence exists to support its effectiveness, particularly in dystonia secondary to disorders such as cerebral palsy. A prospective, open-label, multicenter pilot trial of high-dose trihexyphenidyl was conducted in 23 children aged 4 to 15 years with cerebral palsy judged to have secondary dystonia impairing function in the dominant upper extremity. All children were given trihexyphenidyl at increasing doses over a 9-week period up to a maximum of 0.75 mg/kg/d. Trihexyphenidyl was subsequently tapered off over the next 5 weeks. Objective motor assessments were performed at baseline, 9 weeks, and 15 weeks. The primary outcome measure was the Melbourne Assessment of Unilateral Upper Limb Function, tested in the dominant arm. Tolerability and safety were monitored closely throughout the trial. Of the 31 children who agreed to participate in the study, 5 failed to meet entry criteria and 3 withdrew due to nonserious adverse events (chorea, drug rash, and hyperactivity). Three children required a dosage reduction because of nonserious adverse events but continued to participate. The 23 children who completed the study showed a significant improvement in arm function at 15 weeks (P = .045) but not at 9 weeks (P = .985). Post hoc analysis showed that a subgroup (n = 10) with hyperkinetic dystonia (excess involuntary movements) worsened at 9 weeks (P = .04) but subsequently returned to baseline following taper of the medicine. The authors conclude that scientific evidence for the clinical use of trihexyphenidyl in cerebral palsy remains equivocal. Trihexyphenidyl may be a safe and effective for treatment for arm dystonia in some children with cerebral palsy if given sufficient time to respond to the medication. Post hoc analyses based on the type of movement disorder suggested that children with hyperkinetic forms of dystonia may worsen. A larger, randomized

  3. Lessons Learned from an ICD-10-CM Clinical Documentation Pilot Study

    PubMed Central

    Moczygemba, Jackie; Fenton, Susan H

    2012-01-01

    On October 1, 2013, the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) will be mandated for use in the United States in place of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). This new classification system will used throughout the nation's healthcare system for recording diagnoses or the reasons for treatment or care. A pilot study was conducted to determine whether current levels of inpatient clinical documentation provide the detail necessary to fully utilize the ICD-10-CM classification system for heart disease, pneumonia, and diabetes cases. The design of this pilot study was cross-sectional. Four hundred ninety-one de-identified records from two sources were coded using ICD-10-CM guidelines and codebooks. The findings of this study indicate that healthcare organizations need to assess clinical documentation and identify gaps. In addition, coder proficiency should be assessed prior to ICD-10-CM implementation to determine the need for further education and training in the biomedical sciences, along with training in the new classification system. PMID:22548021

  4. An international prospective cohort study evaluating major vascular complications among patients undergoing noncardiac surgery: the VISION Pilot Study

    PubMed Central

    2011-01-01

    Objectives Among patients undergoing noncardiac surgery, our objectives were to: (1) determine the feasibility of undertaking a large international cohort study; (2) estimate the current incidence of major perioperative vascular events; (3) compare the observed event rates to the expected event rates according to the Revised Cardiac Risk Index (RCRI); and (4) provide an estimate of the proportion of myocardial infarctions without ischemic symptoms that may go undetected without perioperative troponin monitoring. Design An international prospective cohort pilot study. Participants Patients undergoing noncardiac surgery who were > 45 years of age, receiving a general or regional anesthetic, and requiring hospital admission. Measurements Patients had a Roche fourth-generation Elecsys troponin T measurement collected 6 to 12 hours postoperatively and on the first, second, and third days after surgery. Our primary outcome was major vascular events (a composite of vascular death [i.e., death from vascular causes], nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) at 30 days after surgery. Our definition for perioperative myocardial infarction included: (1) an elevated troponin T measurement with at least one of the following defining features: ischemic symptoms, development of pathologic Q waves, ischemic electrocardiogram changes, coronary artery intervention, or cardiac imaging evidence of myocardial infarction; or (2) autopsy findings of acute or healing myocardial infarction. Results We recruited 432 patients across 5 hospitals in Canada, China, Italy, Colombia, and Brazil. During the first 30 days after surgery, 6.3% (99% confidence interval 3.9–10.0) of the patients suffered a major vascular event (10 vascular deaths, 16 nonfatal myocardial infarctions, and 1 nonfatal stroke). The observed event rate was increased 6-fold compared with the event rate expected from the RCRI. Of the 18 patients who suffered a myocardial infarction

  5. Therapeutic horticulture in clinical depression: a prospective study.

    PubMed

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

    2009-01-01

    Clinically depressed persons suffer from impaired mood and distortion of cognition. This study assessed changes in depression severity and perceived attentional capacity of clinically depressed adults (N=18) during a 12-week therapeutic horticulture program. The Beck Depression Inventory (BDI) and Attentional Function Index (AFI) were administered at baseline, twice during (4 and 8 weeks), and immediately after the intervention (12 weeks), and at a 3-month follow-up. Experiences of being away and fascination related to the intervention were measured at 4, 8, and 12 weeks. The mean BDI score declined 9.7 points from pretest (27.3) to posttest (p < .001) and were clinically relevant (deltaBDI > or =6) for 72% of the cases. The mean AFI score increased 10.2 points from pretest (68.8) to posttest (p = .06). The greatest change in BDI and AFI scores occurred in the initial weeks of the intervention. The reduction in BDI scores remained significant and clinically relevant at the 3-month follow-up (N=16). The decline in depression severity during the intervention correlated strongly with the degree to which the participants found that it captured their attention. Therapeutic horticulture may decrease depression severity and improve perceived attentional capacity by engaging effortless attention and interrupting rumination.

  6. Disordered Eating Behaviors in Youth with Type 1 Diabetes: Prospective Pilot Assessment Following Initiation of Insulin Pump Therapy

    PubMed Central

    Markowitz, Jessica T.; Alleyn, Cielo A.; Phillips, Roxanne; Muir, Andrew; Young-Hyman, Deborah

    2013-01-01

    Abstract Background There is risk for disordered eating behaviors in type 1 diabetes, especially related to insulin manipulation. Implementation of insulin pump therapy may encourage either normalization of eating behaviors or a greater focus on food intake due to renewed emphasis on carbohydrate counting. There is need for prospective studies to assess disordered eating behaviors upon implementation of pump therapy using diabetes-specific measurement tools. Subjects and Methods In a multicenter pilot study, 43 youth with type 1 diabetes, 10–17 years old, were assessed prior to pump initiation and after 1 and 6 months of pump therapy. Youth completed the Diabetes-specific Eating Problems Survey-Revised (DEPS-R), a validated measure of risk for both diabetes-specific and general disordered eating behaviors. Results Youth (45% female), 13.3 years old with diabetes for 2.1 years, had a mean hemoglobin A1c of 8.3±1.3% (68±14.5 mmol/mol) at baseline. DEPS-R scores decreased over time (P=0.01). Overall rate of high risk for eating disorders was low. Overweight/obese youth endorsed more disordered eating behaviors than normal-weight participants. DEPS-R scores were correlated with z-score for body mass index at all three time points and with hemoglobin A1c after 1 and 6 months. Hemoglobin A1c did not change significantly over the 6 months and was higher in overweight/obese compared with normal-weight participants. Conclusions Initiation of insulin pump therapy was associated with diminished endorsement of disordered eating behaviors in youth with type 1 diabetes. Longer follow-up studies are needed to assess the impact of insulin pump therapy on glycemic control, weight status, and disordered eating behaviors in this vulnerable population. PMID:23550556

  7. Treating major depression with yoga: A prospective, randomized, controlled pilot trial

    PubMed Central

    Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

    2017-01-01

    Background Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression. Methods Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14–28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22–72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks. Results In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen’s d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for

  8. Clinical variables and implications of the personality on the outcome of bipolar illness: a pilot study

    PubMed Central

    Casas-Barquero, Nieves; García-López, Olga; Fernández-Argüelles, Pedro; Camacho-Laraña, Manuel

    2007-01-01

    Outcome in bipolar patients is affected by comorbidity. Comorbid personality disorders are frequent and may complicate the course of bipolar illness. This pilot study examined a series of 40 euthymic bipolar patients (DSM-IV criteria) (bipolar I disorder 31, bipolar II disorder 9) to assess the effect of clinical variables and the influence of comorbid personality on the clinical course of bipolar illness. Bipolar patients with a diagnosis of comorbid personality disorder (n = 30) were compared with “pure” bipolar patients (n = 10) with regard to demographic, clinical, and course of illness variables. Comorbid personality disorder was diagnosed in 75% of patients according to ICD-10 criteria, with obsessive-compulsive personality disorder being the most frequent type. Sixty-three per cent of subjects had more than one comorbid personality disorder. Bipolar patients with and without comorbid personality disorder showed no significant differences regarding features of the bipolar illness, although the group with comorbid personality disorder showed a younger age at onset, more depressive episodes, and longer duration of bipolar illness. In subjects with comorbid personality disorders, the number of hospitalizations correlated significantly with depressive episodes and there was an inverse correlation between age at the first episode and duration of bipolar illness. These findings, however, should be interpreted taking into account the preliminary nature of a pilot study and the contamination of the sample with too many bipolar II patients. PMID:19300559

  9. UVA1 phototherapy in the treatment of palmoplantar pustulosis: a pilot prospective study.

    PubMed

    Su, Li-Na; Xu, Xin; Tang, Li; Yu, Ning; Ding, Yang-Feng

    2016-11-01

    Palmoplantar pustulosis (PPP) is recalcitrant to traditional topical and systemic therapies. Ultraviolet A1 (UVA1) phototherapy, a new therapeutic approach, has recently been shown good efficacy in the treatment of PPP. The purpose of this study was to evaluate the efficacy and safety of UVA1 therapy for the treatment of PPP. Patients with PPP were treated with UVA1 irradiation three times a week for up to 30 sessions and had a 3-month follow-up visit. UVA1 therapy was conducted with a fixed dose (80 J/cm(2)). Clinical evaluation was based on the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) score. Totally, 62 patients completed the study. The mean PPPASI score decreased from a baseline value of 9.4 ± 2.8 to a value of 4.9 ± 2.4 at 15 sessions, 1.7 ± 1.9 at 30 sessions, and 2.0 ± 2.1 at follow-up visit. A reduction of 75 % in the PPPASI score was observed in 4 (6.5 %) patients at 15 sessions and 45 (72.6 %) patients at 30 sessions. The adverse effects were limited including burning sensation, pruritus, and hyperpigmentation. UVA1 is an effective therapy for PPP with mild side effects.

  10. Panax ginseng therapy for chronic obstructive pulmonary disease: a clinical trial protocol and pilot study

    PubMed Central

    2014-01-01

    Background Panax ginseng (Ren shen) has been used to treat chronic obstructive pulmonary disease (COPD). This article aims to present a study protocol and pilot trial comparing P. ginseng with placebo for treating moderate to very severe COPD. Methods COPD was diagnosed spirometrically, with participants having a forced expiratory volume in one second (FEV1) of between 20% and 79% and FEV1 to forced vital capacity (FVC) ratio of less than 70%. Outcome measures included exacerbation rate, St. Georges Respiratory Questionnaire, COPD Assessment Test and Short-form Health Survey (SF-36). Other outcome measures included the six-minute walk test, FEV1, FVC, relief medication use, use of COPD-specific medical resources, and adverse events. The study is a randomized, double-blind, placebo controlled clinical trial. The method of this pilot trial was based on a planned full-scale trial except that participants were enrolled for ten weeks compared to 52 weeks. In the pilot trial, 14 participants (57–73 years old) with moderate to very severe COPD were recruited from a community health program at a public Chinese medicine hospital in Guangdong Province, China. After a 2-week run-in period, 10 participants were eligible for the study and were randomly assigned to either P. ginseng group (n = 5) (200 mg twice daily for four weeks) or placebo group (n = 5), and then followed-up for an additional 4 weeks for a total of 10 weeks. Results Nine participants completed the trial and one dropped out. The exacerbation rate could not be evaluated because there were no exacerbations. One participant in P. ginseng group reported events of sore throat, cough and fever. Trial investigators did not consider these events as COPD exacerbations or adverse events. Conclusions Participant recruitment, study design, data collection and outcome measurement have been tested in a pilot trial. A full-scale trial is warranted. PMID:25161696

  11. Integrating a prospective pilot trial and patient-derived xenografts to trace metabolic changes associated with acute myeloid leukemia.

    PubMed

    Carrabba, Matteo G; Tavel, Laurette; Oliveira, Giacomo; Forcina, Alessandra; Quilici, Giacomo; Nardelli, Francesca; Tresoldi, Cristina; Ambrosi, Alessandro; Ciceri, Fabio; Bernardi, Massimo; Vago, Luca; Musco, Giovanna

    2016-10-28

    Despite the considerable progress in understanding the molecular bases of acute myeloid leukemia (AML), new tools to link disease biology to the unpredictable patient clinical course are still needed. Herein, high-throughput metabolomics, combined with the other "-omics" disciplines, holds promise in identifying disease-specific and clinically relevant features.In this study, we took advantage of nuclear magnetic resonance (NMR) to trace AML-associated metabolic trajectory employing two complementary strategies. On the one hand, we performed a prospective observational clinical trial to identify metabolic changes associated with blast clearance during the first two cycles of intensive chemotherapy in nine adult patients. On the other hand, to reduce the intrinsic variability associated with human samples and AML genetic heterogeneity, we analyzed the metabolic changes in the plasma of immunocompromised mice upon engraftment of primary human AML blasts.Combining the two longitudinal approaches, we narrowed our screen to seven common metabolites, for which we observed a mirror-like trajectory in mice and humans, tracing AML progression and remission, respectively. We interpreted this set of metabolites as a dynamic fingerprint of AML evolution.Overall, these NMR-based metabolomic data, to be consolidated in larger cohorts and integrated in more comprehensive system biology approaches, hold promise for providing valuable and non-redundant information on the systemic effects of leukemia.

  12. 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

  13. MIH supplementation strategies: prospective clinical and laboratory trial.

    PubMed

    Baroni, C; Marchionni, S

    2011-03-01

    The use of calcium-phosphate casein on hypomineralized molars (molar incisor hypomineralization, MIH) has been proposed but not clinically investigated. Qualitative and quantitative effects of supplementation with a calcium-phosphate casein product on MIH molars were monitored over a period of three years. Molar replicas, minimally invasive biopsies and their SEM microphotographs, plus ESEM/EDX semi-quantitative peaks of elements present in affected enamel were evaluated. Mineralization, morphology, and porosity appeared markedly improved, with calcium and phosphate levels reaching almost normal levels at three years' follow-up. The hypothesis tested was rejected, since calcium-phosphate casein improved enamel morphology in vivo.

  14. 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

  15. Progress and prospects: hurdles to cardiovascular gene therapy clinical trials.

    PubMed

    Hedman, M; Hartikainen, J; Ylä-Herttuala, S

    2011-08-01

    Several gene therapy approaches have been designed for the treatment of cardiovascular diseases. A positive finding is that the safety of cardiovascular gene therapy has been excellent even in long-term follow-up. However, several hurdles to this field are still present. A major disappointing feature of the trials is that while preclinical and uncontrolled phase-I gene therapy trials have been positive, none of the randomized controlled phase-II/III cardiovascular gene therapy trials have shown clinically relevant positive effects. Low gene transfer efficiency seems to be associated with several trials. A sophisticated efficient delivery method for cardiovascular applications is still lacking and only low concentrations of the gene product are produced in the target tissues. Only a few gene therapy vectors can be produced in large scale. In addition, inflammatory reactions against vectors and inability to regulate gene expression are still present. Furthermore, a strong placebo effect is affecting the results in gene therapy trials, and long-term trials have become more difficult to conduct because of the multiplicity of therapies applied simultaneously on the patients. This review summarizes advances and obstacles of current cardiovascular clinical gene therapy trials.

  16. Neural response imaging (NRI) cochlear mapping: prospects for clinical application.

    PubMed

    Arnold, L; Lindsey, P; Hacking, C; Boyle, P

    2007-12-01

    The objective of the study was to investigate the potential for clinical application of neural response imaging (NRI) cochlear mapping. Cochlear mapping was performed at each fitting session up to at least six months following initial fitting. Stimulation was delivered to one electrode site. NRI was recorded from each of the remaining sites. The procedure was repeated for apical, medial and basal stimulation sites, stimulating at subjective threshold and most comfortable levels. Responses were obtained in five out of six subjects and are discussed in terms of: reproducibility, quality, changes over time. Cochlear mapping provided repeatable data that gave interesting insights into the implanted cochlea. Further work is required to determine whether this approach could contribute to programme optimisation.

  17. First clinical pilot study with intravascular polarization sensitive optical coherence tomography (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Villiger, Martin; Karanasos, Antonios; Ren, Jian; Lippok, Norman; Shishkov, Milen; Daemen, Joost; Van Mieghem, Nicolas; Diletti, Roberto; Valgimigli, Marco; van Geuns, Robert-Jan; de Jaegere, Peter; Zijlstra, Felix; van Soest, Gijs; Nadkarni, Seemantini; Regar, Evelyn; Bouma, Brett E.

    2016-02-01

    Polarization sensitive (PS) OCT measures the polarization states of the light backscattered by tissue and provides measures of tissue birefringence and depolarization in addition to the structural OCT signal. Ex vivo studies have demonstrated that birefringence is increased in tissue rich in collagen and with elevated smooth muscle cell content. Preliminary data further suggests that depolarization can identify regions of macrophage infiltration, lipid, and irregularly arranged collagen fibers. These are important aspects of the mechanical integrity and vulnerability of atherosclerotic plaques. To evaluate the potential of PS-OCT in the clinical setting, we combined our custom PS-OCT system with commercially available OCT catheters (Fastview, Terumo Corporation) and performed a pilot study in 30 patients, scheduled to undergo percutaneous coronary intervention (PCI) on the grounds of stable or unstable angina. A total of 82 pullbacks in 39 vessels were performed, either in the native coronary arteries or post procedure. Comparing consecutive pullbacks of the same coronary artery, we found excellent agreement between the polarization features in the repeat pullbacks, validating the repeatability and robustness of PS-OCT in the clinical in vivo setting. In addition we observed that the birefringence and depolarization features vary significantly across lesions with identical structural OCT appearance, suggesting morphological subtypes. This first human pilot study proved the feasibility and robustness of intravascular PS-OCT. PS-OCT achieves improved tissue characterization and may help in identifying high-risk plaques, with the potential to ultimately improve risk stratification and help guiding PCI.

  18. The use of clinical logs to improve nursing students' metacognition: a pilot study.

    PubMed

    Fonteyn, M E; Cahill, M

    1998-07-01

    The purpose of this study was to examine the effectiveness of the use of a reflective clinical log to improve students' thinking strategies and metacognition (cognitive awareness). Rather than prepare a written nursing care plan prior to entering the clinical setting, students instead were asked to write in a clinical log at the completion of their clinical day, reflecting upon client problems that they had identified, the data that were used to identify these problems, the nursing interventions that were used, and the results of these interventions. The students reported that they preferred the use of a reflective log over writing nursing care plans and they felt that the logs improved their ability to think about their thinking (i.e. their metacognition). The results of this pilot study indicate that reflection in clinical logs assists students to become more active learners, to manage their own thinking, and to improve their metacognition. Additional research in this area is needed to confirm study findings and to provide further understanding regarding the effectiveness of clinical logs as a teaching strategy to improve students' metacognition.

  19. Paroxysmal hemicrania: a prospective clinical study of 31 cases.

    PubMed

    Cittadini, Elisabetta; Matharu, Manjit S; Goadsby, Peter J

    2008-04-01

    Paroxysmal hemicrania is a rare syndrome characterized by repeated attacks of strictly unilateral, severe, short-lasting pain occurring with cranial autonomic features. The hallmarks of this syndrome are the relatively short attacks and the exquisite response to indometacin. We describe the phenotype of this condition in a series of 31 patients. The mean duration of attack was 17 min. The mean attack frequency was 11. The distribution of the pain was orbital and temporal in 77% of the patients, retro-orbital in 61%, frontal in 55%, occipital in 42%; although pain was also reported in the vertex, second division of trigeminal nerve, neck, nose, jaw, parietal region, ear, teeth, eyebrow, shoulder (ipsilateral and bilateral), arm and third division of trigeminal nerve. Of the cohort, 87% had lacrimation, 68% had conjunctival injection, 58% rhinorrhoea, 54% nasal congestion, ptosis and facial flushing. Other cranial autonomic features include eyelid oedema, forehead/facial sweating, sense of aural fullness and periaural swelling, miosis, mydriasis and swelling of the cheek. The majority of the patients (80%) were agitated or restless, or both, with the pain and 26% were aggressive. All patients had positive placebo control indometacin test (100-200 mg intramuscularly), or a positive oral indometacin trial or both. We suggest the International Headache Society criteria be revised to remove specification of attack site, and to include the full range of cranial autonomic features. Currently, the sine qua non for paroxysmal hemicrania is a response to indometacin. Since there is no reliable clinical marker of that response we recommend an indometacin test, either orally or by injection for any patient with lateralized discrete attacks of head pain with associated cranial autonomic symptoms.

  20. Eccentric treatment for patellar tendinopathy: a prospective randomised short‐term pilot study of two rehabilitation protocols

    PubMed Central

    Frohm, Anna; Saartok, Tönu; Halvorsen, Kjartan; Renström, Per

    2007-01-01

    Objective To compare the efficacy and safety of two eccentric rehabilitation protocols for patients with symptomatic patellar tendinopathy. A new eccentric overload training device was compared with the present standard eccentric rehabilitation programme on a decline board. Design Prospective, randomised clinical trial. Setting Sports rehabilitation clinic, university sports laboratory, supplemented with home exercises. Patients 20 competitive and recreational athletes, all with clinical diagnosis of patellar tendinopathy, verified by MRI or ultrasound imaging. Interventions A 12‐week rehabilitation period, either with bilateral eccentric overload strength training using the Bromsman device twice a week or with unilateral eccentric body load training using a decline board twice a week, supplemented with daily home exercises. Outcome measures The primary outcome was pain and function, assessed by the Swedish Victorian Institute of Sport Assessment for Patella (VISA‐P) score. Secondary outcome measures were isokinetic muscle torque, dynamic function and muscle flexibility, as well as pain level estimations using visual analogue scale (VAS). Side effects were registered. Results Both treatment groups improved in the short term according to the VISA‐P scores during the 12‐week rehabilitation period. However, there were no significant differences between the groups in terms of pain and function. After a 3‐month rehabilitation period, most patients could be regarded as improved enough to be able to return to training and sports. No serious side effects were detected in either group. Conclusion In patients with patellar tendinopathy pain, two‐legged eccentric overload training twice per week, using the new device (Bromsman), was as efficient and safe as the present standard daily eccentric one‐legged rehabilitation‐training regimen using a decline board. PMID:17289855

  1. A single center, pilot, double-blinded, randomized, comparative, prospective clinical study to evaluate improvements in the structure and function of facial skin with tazarotene 0.1% cream alone and in combination with GliSODin® Skin Nutrients Advanced Anti-Aging Formula

    PubMed Central

    Goldberg, Lawrence D; Crysler, Corina

    2014-01-01

    Background Superoxide dismutase (SOD) reduces the reactive oxygen species formation associated with oxidative stress. An imbalance between free radicals and antioxidants can lead to accelerated aging. GliSODin® Skin Nutrients Advanced Anti-Aging Formula (GAAF) is an SOD-containing dietary nutricosmetic formulated with other nutraceuticals that promote improvements in the structure and function of the skin, including hydration, elasticity, structural integrity, and photoaging caused by oxidative stress. Tazarotene cream 0.1% (TAZ) is a United States Food and Drug Administration-approved drug indicated for use in the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines when taken in conjunction with a comprehensive skin care and sun avoidance program. Objective To determine if the antioxidant, anti-aging, hydrating and skin-rejuvenating properties of GAAF complement the retinoic actions of TAZ to improve the structure and function of facial skin. Method A 90-day comparative study of ten subjects with facial photodamage; daily topical application of TAZ was used in combination with three capsules of GAAF (780 mg each) or placebo orally, with food, per the randomization allocation. Results After 90 days of treatment, TAZ alone and in combination with GAAF improved fine wrinkles (↓1.2 versus 2.0), mottled hyperpigmentation (↓2.2 versus 2.8) and overall photodamage (↓1.0 versus 1.8), as well as patient-reported response to treatment (↓2.0 versus 1.6). At week 12, TAZ/GAAF combination treatment (Group A) versus TAZ treatment alone (Group C) was of significant clinical benefit, with respect to fine wrinkling (14.7%/41.7%), overall photodamage (15.6%/53.0%), skin moisture (19.1%/103.2%), skin elasticity (12.8%/87.7%), and response to treatment (8.8%/21.4%). Conclusion The study suggests GAAF in combination with TAZ is safe and provides significant clinical benefit with relative improvement in facial fine

  2. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial

    PubMed Central

    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-01-01

    Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18–65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Findings Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large

  3. Training Opioid Addiction Treatment Providers to Adopt Contingency Management: A Prospective Pilot Trial of a Comprehensive Implementation Science Approach

    PubMed Central

    Becker, Sara J.; Squires, Daniel D.; Strong, David R.; Barnett, Nancy P.; Monti, Peter M.; Petry, Nancy M.

    2016-01-01

    Background Few prospective studies have evaluated theory-driven approaches to the implementation of evidence-based opioid treatment. This study compared the effectiveness of an implementation model (Science to Service Laboratory; SSL) to training as usual (TAU) in promoting the adoption of contingency management across a multi-site opiate addiction treatment program. We also examined whether the SSL affected putative mediators of contingency management adoption (perceived innovation characteristics and organizational readiness to change). Methods Sixty treatment providers (39 SSL, 21 TAU) from 15 geographically diverse satellite clinics (7 SSL, 8 TAU) participated in the 12-month study. Both conditions received didactic contingency management training and those in the pre-determined experimental region received 9 months of SSL-enhanced training. Contingency management adoption was monitored biweekly, while putative mediators were measured at baseline, 3-, and 12-months. Results Relative to providers in the TAU region, treatment providers in the SSL region had comparable likelihood of contingency management adoption in the first 20 weeks of the study, and then significantly higher likelihood of adoption (odds ratios = 2.4-13.5) for the remainder of the study. SSL providers also reported higher levels of one perceived innovation characteristic (Observability) and one aspect of organizational readiness to change (Adequacy of Training Resources), although there was no evidence that the SSL affected these putative mediators over time. Conclusions Results of this study indicate that a fully powered randomized trial of the SSL is warranted. Considerations for a future evaluation are discussed. PMID:26682582

  4. Pilot clinical application of an adaptive robotic system for young children with autism

    PubMed Central

    Bekele, Esubalew; Crittendon, Julie A; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E

    2013-01-01

    It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small group of preschool children with autism spectrum disorders (n = 6) and a control group (n = 6). Children in both groups spent more time looking at the humanoid robot and were able to achieve a high level of accuracy across trials. However, across groups, children required higher levels of prompting to successfully orient within robot-administered trials. The results highlight both the potential benefits of closed-loop adaptive robotic systems as well as current limitations of existing humanoid-robotic platforms. PMID:24104517

  5. Development, Implementation, and Evaluation of a Pilot Parenting Educational Intervention in a Pregnancy Buprenorphine Clinic.

    PubMed

    Giles, Averie C; Ren, Dianxu; Founds, Sandra

    2016-01-01

    We developed a pilot evidence-based prenatal educational intervention to increase knowledge of neonatal abstinence syndrome (NAS) and early parenting skills for women with opiate dependency who enrolled in a pregnancy buprenorphine clinic. We developed, implemented, and tested modules regarding expectations during newborn hospitalization for observation or treatment of NAS and regarding evidence-based parenting skills in response to NAS behaviors. Testing evaluated baseline knowledge of early parenting skills with newborns at risk for NAS and change from baseline after the educational intervention. No statistically significant difference in composite knowledge scores was observed. A brief survey completed by the participants postpartum affirmed the perception of women that the educational intervention effectively prepared them for the early postpartum period while their newborns were hospitalized.

  6. Impact of a clinical pharmacist on a cardiovascular surrogate endpoint: a pilot study

    PubMed Central

    Ripley, Toni L.; Hennebry, Thomas A.; Sanders, Tiffany N.; Harrison, Donald; Rathbun, R. Chris

    Utilizing a multidisciplinary approach to management of patients with certain chronic cardiovascular diseases (CVD) has been shown to improve treatment outcomes. The role of clinical pharmacists in comprehensive outpatient CVD management has not been evaluated. Objective The objective of this pilot study was to evaluate the impact of a clinical pharmacist added to cardiologist care on blood pressure (BP), a key surrogate marker of CVD, in outpatients with CVD compared to cardiologist care alone. Methods A retrospective, matched-control study was conducted in patients established in a cardiovascular clinic. The intervention was referral to a pharmacist clinic; control was usual care from the cardiologist. The surrogate marker evaluated was the change in BP. Results Patients in the pharmacist-intervention (n=57) experienced significant reductions in diastolic BP (-2.6 mmHg, p=0.05) and non-significant reductions in systolic BP (-4.3 mmHg, p=0.16) compared to baseline, whereas patients in the control group experienced non-significant increases in both systolic and diastolic BP (+1.6/+0.7 mmHg, p=NS). Similarly, there were significant reductions in diastolic BP and non-significant reductions in systolic BP for the intervention group when compared to controls (difference 3.3 mmHg, p=0.04 and 5.9 mmHg, p=0.1, respectively). Lastly, the proportion of patients categorized as having Stage 2 BP was significantly reduced in the intervention group (p=0.02), but not in the controls (p=0.5). Conclusions The multidisciplinary model of care that included a clinical pharmacist reduced BP more than usual care by a cardiologist alone. This benefit was demonstrated in complex patients with CVD who were already receiving specialized care. The impact of this model on clinical outcomes requires further evaluation and should be a high priority given the burden of CVD in the population. PMID:24155834

  7. Feasibility of Providing Culturally Relevant, Brief Interpersonal Psychotherapy for Antenatal Depression in an Obstetrics Clinic: A Pilot Study

    ERIC Educational Resources Information Center

    Grote, Nancy K.; Bledsoe, Sarah E.; Swartz, Holly A.; Frank, Ellen

    2004-01-01

    Objective: To minimize barriers to care, ameliorate antenatal depression, and prevent postpartum depression, we conducted a pilot study to assess the feasibility of providing brief interpersonal psychotherapy (IPT-B) to depressed, pregnant patients on low incomes in an obstetrics and gynecological (OB/GYN) clinic. Method: Twelve pregnant,…

  8. Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

    ERIC Educational Resources Information Center

    Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

    2016-01-01

    Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

  9. Why clinical nurse educators adopt innovative teaching strategies: a pilot study.

    PubMed

    Phillips, Janet M; Vinten, Sharon A

    2010-01-01

    The purpose of this pilot study was to describe intentions to adopt innovative teaching strategies in clinical educators who have participated in an online course focusing on the role of clinical teaching (N = 71). Innovative teaching strategies were defined as those that embrace the tenets of sociocultural theory, a student-centered approach whereby the role of the nurse educator is to motivate and support the student and, in mutual process, to push students to reach toward their learning potential by using guiding techniques that can be erected or gradually reduced based on the individual student's learning needs. Participants stated that three factors proposed in the Rogers theory of diffusion of innovation (compatibility, trialability, and relative advantage) would be most influential in the adoption of innovative teaching strategies. Encouraging students to explore and apply new knowledge was described as the teaching strategy most likely to be adopted. Intent to adopt innovative teaching strategies may provide insight into the development of organizational climates in schools of nursing that could foster needed changes in clinical teaching.

  10. A pilot project using evidence-based clinical pathways and payment reform in China's rural hospitals shows early success.

    PubMed

    Cheng, Tsung-Mei

    2013-05-01

    Reforming China's public hospitals to curb widespread overtreatment and improve the quality and affordability of care has been the most challenging aspect of that nation's ambitious health reform, which began in 2009. This article describes a pilot project under way in several of China's provinces that combines payment reform with the implementation of evidence-based clinical pathways at a few hospitals serving rural areas. Results to date include reduced length-of-stay and prescription drug use and higher patient and provider satisfaction. These early results suggest that the pilot may be achieving its goals, which may have far-reaching and positive implications for China's ongoing reform.

  11. Maternal Stress and Young Children's Behavioural Development: A Prospective Pilot Study from 8 to 36 Months in a Finnish Sample

    ERIC Educational Resources Information Center

    Haapsamo, Helena; Pollock-Wurman, Rachel A.; Kuusikko-Gauffin, Sanna; Ebeling, Hanna; Larinen, Katja; Soini, Hannu; Moilanen, Irma

    2013-01-01

    The relationship between maternal parenting stress and infant/toddler behavioural development was examined in a longitudinal pilot study. Fifty mothers reported parenting stress via the Parenting Stress Index-Short Form when their infants were eight months old. Parents subsequently rated their children's emotional and behavioural problems with the…

  12. Development of a clinical decision support system for diabetes care: A pilot study.

    PubMed

    Sim, Livvi Li Wei; Ban, Kenneth Hon Kim; Tan, Tin Wee; Sethi, Sunil Kumar; Loh, Tze Ping

    2017-01-01

    Management of complex chronic diseases such as diabetes requires the assimilation and interpretation of multiple laboratory test results. Traditional electronic health records tend to display laboratory results in a piecemeal and segregated fashion. This makes the assembly and interpretation of results related to diabetes care challenging. We developed a diabetes-specific clinical decision support system (Diabetes Dashboard) interface for displaying glycemic, lipid and renal function results, in an integrated form with decision support capabilities, based on local clinical practice guidelines. The clinical decision support system included a dashboard feature that graphically summarized all relevant laboratory results and displayed them in a color-coded system that allowed quick interpretation of the metabolic control of the patients. An alert module informs the user of tests that are due for repeat testing. An interactive graph module was also developed for better visual appreciation of the trends of the laboratory results of the patient. In a pilot study involving case scenarios administered via an electronic questionnaire, the Diabetes Dashboard, compared to the existing laboratory reporting interface, significantly improved the identification of abnormal laboratory results, of the long-term trend of the laboratory tests and of tests due for repeat testing. However, the Diabetes Dashboard did not significantly improve the identification of patients requiring treatment adjustment or the amount of time spent on each case scenario. In conclusion, we have developed and shown that the use of the Diabetes Dashboard, which incorporates several decision support features, can improve the management of diabetes. It is anticipated that this dashboard will be most helpful when deployed in an outpatient setting, where physicians can quickly make clinical decisions based on summarized information and be alerted to pertinent areas of care that require additional attention.

  13. Italian multicentre study on microbial environmental contamination in dental clinics: a pilot study.

    PubMed

    Pasquarella, Cesira; Veronesi, Licia; Castiglia, Paolo; Liguori, Giorgio; Montagna, Maria Teresa; Napoli, Christian; Rizzetto, Rolando; Torre, Ida; Masia, Maria Dolores; Di Onofrio, Valeria; Colucci, Maria Eugenia; Tinteri, Carola; Tanzi, Marialuisa

    2010-09-01

    The dental practice is associated with a high risk of infections, both for patients and healthcare operators, and the environment may play an important role in the transmission of infectious diseases. A microbiological environmental investigation was carried out in six dental clinics as a pilot study for a larger multicentre study that will be performed by the Italian SItI (Society of Hygiene, Preventive Medicine and Public Health) working group "Hygiene in Dentistry". Microbial contamination of water, air and surfaces was assessed in each clinic during the five working days of the week, before and during treatments. Air and surfaces were also examined at the end of the daily activity. A wide variation was found in microbial environmental contamination, both within the participating clinics and relative to the different sampling times. Microbial water contamination in Dental Unit Water Systems (DUWS) reached values of up to 26x10(4)cfu/mL (colony forming units per millilitre). P. aeruginosa was found in 33% of the sampled DUWS and Legionella spp. in 50%. A significant decrease in the Total Viable Count (TVC) was recorded during the activity. Microbial air contamination showed the highest levels during dental treatments and tended to decrease at the end of the working activity (p<0.05). Microbial buildup on surfaces increased significantly during the working hours. As these findings point out, research on microbial environmental contamination and the related risk factors in dental clinics should be expanded and should also be based on larger collections of data, in order to provide the essential knowledge aimed at targeted preventive interventions.

  14. Development of a clinical decision support system for diabetes care: A pilot study

    PubMed Central

    Sim, Livvi Li Wei; Ban, Kenneth Hon Kim; Tan, Tin Wee; Sethi, Sunil Kumar; Loh, Tze Ping

    2017-01-01

    Management of complex chronic diseases such as diabetes requires the assimilation and interpretation of multiple laboratory test results. Traditional electronic health records tend to display laboratory results in a piecemeal and segregated fashion. This makes the assembly and interpretation of results related to diabetes care challenging. We developed a diabetes-specific clinical decision support system (Diabetes Dashboard) interface for displaying glycemic, lipid and renal function results, in an integrated form with decision support capabilities, based on local clinical practice guidelines. The clinical decision support system included a dashboard feature that graphically summarized all relevant laboratory results and displayed them in a color-coded system that allowed quick interpretation of the metabolic control of the patients. An alert module informs the user of tests that are due for repeat testing. An interactive graph module was also developed for better visual appreciation of the trends of the laboratory results of the patient. In a pilot study involving case scenarios administered via an electronic questionnaire, the Diabetes Dashboard, compared to the existing laboratory reporting interface, significantly improved the identification of abnormal laboratory results, of the long-term trend of the laboratory tests and of tests due for repeat testing. However, the Diabetes Dashboard did not significantly improve the identification of patients requiring treatment adjustment or the amount of time spent on each case scenario. In conclusion, we have developed and shown that the use of the Diabetes Dashboard, which incorporates several decision support features, can improve the management of diabetes. It is anticipated that this dashboard will be most helpful when deployed in an outpatient setting, where physicians can quickly make clinical decisions based on summarized information and be alerted to pertinent areas of care that require additional attention. PMID

  15. Prospective, Multicentre, Nationwide Clinical Data from 600 Cases of Acute Pancreatitis

    PubMed Central

    Párniczky, Andrea; Kui, Balázs; Szentesi, Andrea; Balázs, Anita; Szűcs, Ákos; Mosztbacher, Dóra; Czimmer, József; Sarlós, Patrícia; Bajor, Judit; Gódi, Szilárd; Vincze, Áron; Illés, Anita; Szabó, Imre; Pár, Gabriella; Takács, Tamás; Czakó, László; Szepes, Zoltán; Rakonczay, Zoltán; Izbéki, Ferenc; Gervain, Judit; Halász, Adrienn; Novák, János; Crai, Stefan; Hritz, István; Góg, Csaba; Sümegi, János; Golovics, Petra; Varga, Márta; Bod, Barnabás; Hamvas, József; Varga-Müller, Mónika; Papp, Zsuzsanna; Sahin-Tóth, Miklós; Hegyi, Péter

    2016-01-01

    Objective The aim of this study was to analyse the clinical characteristics of acute pancreatitis (AP) in a prospectively collected, large, multicentre cohort and to validate the major recommendations in the IAP/APA evidence-based guidelines for the management of AP. Design Eighty-six different clinical parameters were collected using an electronic clinical research form designed by the Hungarian Pancreatic Study Group. Patients 600 adult patients diagnosed with AP were prospectively enrolled from 17 Hungarian centres over a two-year period from 1 January 2013. Main Results With respect to aetiology, biliary and alcoholic pancreatitis represented the two most common forms of AP. The prevalence of biliary AP was higher in women, whereas alcoholic AP was more common in men. Hyperlipidaemia was a risk factor for severity, lack of serum enzyme elevation posed a risk for severe AP, and lack of abdominal pain at admission demonstrated a risk for mortality. Abdominal tenderness developed in all the patients with severe AP, while lack of abdominal tenderness was a favourable sign for mortality. Importantly, lung injury at admission was associated with mortality. With regard to laboratory parameters, white blood cell count and CRP were the two most sensitive indicators for severe AP. The most common local complication was peripancreatic fluid, whereas the most common distant organ failure in severe AP was lung injury. Deviation from the recommendations in the IAP/APA evidence-based guidelines on fluid replacement, enteral nutrition and timing of interventions increased severity and mortality. Conclusions Analysis of a large, nationwide, prospective cohort of AP cases allowed for the identification of important determinants of severity and mortality. Evidence-based guidelines should be observed rigorously to improve outcomes in AP. PMID:27798670

  16. “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

  17. Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot: Multicenter Implementation of the Common Data Elements for Traumatic Brain Injury

    PubMed Central

    Yue, John K.; Vassar, Mary J.; Lingsma, Hester F.; Cooper, Shelly R.; Okonkwo, David O.; Valadka, Alex B.; Gordon, Wayne A.; Maas, Andrew I. R.; Mukherjee, Pratik; Yuh, Esther L.; Puccio, Ava M.; Schnyer, David M.; Casey, Scott S.; Cheong, Maxwell; Dams-O'Connor, Kristen; Hricik, Allison J.; Knight, Emily E.; Kulubya, Edwin S.; Menon, David K.; Morabito, Diane J.; Pacheco, Jennifer L.; Sinha, Tuhin K.

    2013-01-01

    Abstract Traumatic brain injury (TBI) is among the leading causes of death and disability worldwide, with enormous negative social and economic impacts. The heterogeneity of TBI combined with the lack of precise outcome measures have been central to the discouraging results from clinical trials. Current approaches to the characterization of disease severity and outcome have not changed in more than three decades. This prospective multicenter observational pilot study aimed to validate the feasibility of implementing the TBI Common Data Elements (TBI-CDEs). A total of 650 subjects who underwent computed tomography (CT) scans in the emergency department within 24 h of injury were enrolled at three level I trauma centers and one rehabilitation center. The TBI-CDE components collected included: 1) demographic, social and clinical data; 2) biospecimens from blood drawn for genetic and proteomic biomarker analyses; 3) neuroimaging studies at 2 weeks using 3T magnetic resonance imaging (MRI); and 4) outcome assessments at 3 and 6 months. We describe how the infrastructure was established for building data repositories for clinical data, plasma biomarkers, genetics, neuroimaging, and multidimensional outcome measures to create a high quality and accessible information commons for TBI research. Risk factors for poor follow-up, TBI-CDE limitations, and implementation strategies are described. Having demonstrated the feasibility of implementing the TBI-CDEs through successful recruitment and multidimensional data collection, we aim to expand to additional study sites. Furthermore, interested researchers will be provided early access to the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) data set for collaborative opportunities to more precisely characterize TBI and improve the design of future clinical treatment trials. (ClinicalTrials.gov Identifier NCT01565551.) PMID:23815563

  18. Why Prospectively Randomized Clinical Trials Have Been Rare in Reproductive Medicine and Will Remain So?

    PubMed

    Gleicher, Norbert; Kushnir, Vitaly A; Barad, David H

    2016-01-01

    There is almost unanimity that modern medicine should be "evidence based." In this context, lack of prospectively randomized clinical trials (RCTs) is widely lamented in reproductive medicine. Some leading voices, indeed, increasingly suggest that only RCT-based clinical conclusions should be integrated into clinical practice, since lower levels of evidence are inadequate. We have argued that reproductive medicine requires special considerations because, like clinical oncology, fertility treatments (especially in older women) are time dependent. Unlike clinical oncology, reproductive medicine, however, does not receive substantial financial research support from government or industry and, at least in the United States, has, therefore, to be primarily funded via patient revenues. Given a 50% chance of receiving placebo, infertility patients are, understandably, reluctant to fund their own RCTs. We here selectively review this subject, contrasting opposing opinions recently published in the literature by a prominent reproductive scientist and one of the world's leading experts on evidence-based medicine. Placing these recent publications into the evolving context of infertility practice, as also addressed in this journal in recent publications, we conclude that objective reasons explain why relatively few RCTs are performed in reproductive medicine and predict that this will not change in the foreseeable future. Reproductive medicine, therefore, has to find ways to develop satisfactory clinical evidence in other ways, satisfying patients' rights to easy access to potentially beneficial medical treatments with low costs and low risks. The RCTs should be reserved for relatively high risk and/or high cost treatments.

  19. Calcium intake and risk of cardiovascular disease: a review of prospective studies and randomized clinical trials.

    PubMed

    Wang, Lu; Manson, JoAnn E; Sesso, Howard D

    2012-04-01

    The potential effects of inadequate or excessive calcium supply on cardiovascular disease (CVD) are receiving growing attention. We review experimental, epidemiologic, and clinical evidence regarding the role of calcium intake in the development of CVD in adults. In vitro and in vivo laboratory studies have shown that calcium may affect the risk of developing CVD through multiple mechanisms including blood cholesterol, insulin secretion and sensitivity, vasodilation, inflammatory profile, thrombosis, obesity, and vascular calcification. A number of prospective epidemiologic studies have examined the relationship between dietary calcium intake and CVD incidence or mortality in middle-aged and older adults. The results were inconsistent, and the pooled data do not strongly support a significant effect of greater dietary calcium intake on the risk of coronary artery disease (CAD) or stroke. Only a few prospective studies have examined calcium supplement use in association with risk of CVD. The pooled data show no significant benefits of calcium supplement use in reducing the risk of CAD or stroke. No randomized clinical trial has specifically tested the effect of calcium supplementation on CVD as its primary endpoint. Secondary analyses in existing trials to date suggest a neutral effect of calcium (with or without vitamin D) supplements on CVD events, but do not allow for a definitive conclusion. A large percentage of Americans, particularly older adults, fail to meet the US recommendations for optimal calcium intake and are encouraged to increase daily calcium consumption. More prospective cohort studies and large-scale randomized trials are needed to further evaluate the risks or benefits of calcium supplementation on CVD endpoints as the primary pre-specified outcome.

  20. 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

  1. 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.

  2. Improved patient satisfaction using ingenol mebutate gel 0.015% for the treatment of facial actinic keratoses: a prospective pilot study.

    PubMed

    Emilio, Joanna; Schwartz, Michelle; Feldman, Eleanor; Bieber, Amy Kalowitz; Bienenfeld, Amanda; Jung, Min-Kyung; Siegel, Daniel M; Markowitz, Orit

    2016-01-01

    Actinic keratoses (AKs), especially on areas of the face, have a negative impact on a patient's quality of life (QoL). These lesions manifest on sun-damaged skin and have the potential to progress to squamous cell carcinoma. Field-directed therapy alone and in combination with lesion-directed treatment is effective in clearing both visible and nonvisible AK lesions. Topical treatments of AKs thus have the potential to improve a patient's well-being. However, evidence demonstrating improvements in patient QoL is limited, and is mostly based on observational or retrospective studies. Some prospective studies have reported unchanged or even worsening QoL despite excellent treatment outcomes. Our prospective, pilot study demonstrated a significant increase in QoL in 28 subjects with AKs of the face treated with ingenol mebutate gel 0.015%. QoL was assessed at days 0 and 60 using the Skindex-16 survey. Mean overall scores improved from 24.5% at baseline to 15.5% at day 60 (P=0.031). Improvements in QoL were consistent with an 80% reduction in AK lesion number at day 60. These improved QoL findings are in line with those from a recent retrospective study using ingenol mebutate 0.015% gel. This study therefore further demonstrates the potential for field therapy to improve both treatment outcomes and patient satisfaction.

  3. 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

  4. Skill learning in patients with moderate Alzheimer's disease: a prospective pilot-study of waltz-lessons.

    PubMed

    Rösler, Alexander; Seifritz, Erich; Kräuchi, Kurt; Spoerl, David; Brokuslaus, Ilona; Proserpi, Sara-Maria; Gendre, Annekäthi; Savaskan, Egemen; Hofmann, Marc

    2002-12-01

    The authors report the effect of a 12-day prospective, blinded dance-learning trial in 5 patients with moderate Alzheimer's disease (AD) and 5 age-matched depressed patients. Patients with AD showed a significant effect in procedural learning whereas depressed patients did not. These findings suggest potential implications for therapeutic interventions in patients with moderate AD.

  5. Cardiovascular medicine at face value: a qualitative pilot study on clinical axiology

    PubMed Central

    2013-01-01

    Introduction Cardiology is characterized by its state-of-the-art biomedical technology and the predominance of Evidence-Based Medicine. This predominance makes it difficult for healthcare professionals to deal with the ethical dilemmas that emerge in this subspecialty. This paper is a first endeavor to empirically investigate the axiological foundations of the healthcare professionals in a cardiology hospital. Our pilot study selected, as the target population, cardiology personnel not only because of their difficult ethical deliberations but also because of the stringent conditions in which they have to make them. Therefore, there is an urgent need to reconsider clinical ethics and Value-Based Medicine. This study proposes a qualitative analysis of the values and the virtues of healthcare professionals in a cardiology hospital in order to establish how the former impact upon the medical and ethical decisions made by the latter. Results We point out the need for strengthening the roles of healthcare personnel as educators and guidance counselors in order to meet the ends of medicine, as well as the need for an ethical discernment that is compatible with our results, namely, that the ethical values developed by healthcare professionals stem from their life history as well as their professional education. Conclusion We establish the kind of actions, communication skills and empathy that are required to build a stronger patient-healthcare professional relationship, which at the same time improves prognosis, treatment efficiency and therapeutic adhesion. PMID:23531271

  6. A prospective 9-month human clinical evaluation of Laser-Assisted New Attachment Procedure (LANAP) therapy.

    PubMed

    Nevins, Marc; Kim, Soo-Woo; Camelo, Marcelo; Martin, Ignacio Sanz; Kim, David; Nevins, Myron

    2014-01-01

    This investigation was designed and implemented as a single-center, prospective study to evaluate the clinical response to the Laser-Assisted New Attachment Procedure (LANAP). Eight patients with advanced periodontitis were enrolled and treated with full-mouth LANAP therapy and monitored for 9 months. Fullmouth clinical measurements, including clinical attachment level (CAL), probing depth (PD), and recession, were provided at baseline and after 9 months of healing by a single calibrated examiner, including a total of 930 sites and 444 sites with initial PD equal to or greater than 5 mm. Clinical results for the 930 sites measured pre- and postoperatively revealed that mean PD was reduced from 4.62 ± 2.29 mm to 3.14 ± 1.48 mm after 9 months (P < .05). CAL decreased from 5.58 ± 2.76 mm to 4.66 ± 2.10 mm (P < .05) and recession increased from 0.86 ± 1.31 mm to 1.52 ± 1.62 after 9 months (P < .05). For the subset of 444 sites with initial PD greater than or equal to 5 mm, the PD decreased from 6.50 ± 2.07 mm to 3.92 ± 1.54 mm (P < .05) and CAL decreased from 7.42 ± 2.70 mm to 5.78 ± 2.06 mm (P < .05). As demonstrated by the clinical evaluation, the majority of treated sites demonstrated clinical improvement. LANAP therapy should be further investigated with long-term clinical trials to compare the stability of clinical results with conventional therapy.

  7. A clinical pilot study of lignin--ascorbic acid combination treatment of herpes simplex virus.

    PubMed

    Lopez, Blanca Silvia Gonzalez; Yamamoto, Masaji; Utsumi, Katsuaki; Aratsu, Chiaki; Sakagami, Hiroshi

    2009-01-01

    Antiviral drugs as well as natural remedies have been used to reduce symptoms and the rate of recurrences of herpes simplex virus type 1 (HSV-1) infection, a common disease. To evaluate anti-HSV-1 activity of a pine cone lignin and ascorbic acid treatment, a clinical pilot study was carried out. Forty-eight healthy patients of both genders between 4 and 61 years old (mean: 31+/-16 years), with active lesions of HSV-1, took part in the study. According to the HSV-1 stage at the presentation, the patients were classified into the prodromic (16 patients), erythema (11 patients), papule edema (1 patient), vesicle/pustule (13 patients) and ulcer stages (7 patients). One mg of lignin-ascorbic acid tablet or solution was orally administered three times daily for a month. Clinical evaluations were made daily the first week and at least three times a week during the second week after the onset and every six months during the subsequent year to identify recurrence episodes. The patients who began the lignin-ascorbic acid treatment within the first 48 hours of symptom onset did not develop HSV-1 characteristic lesions, whereas those patients who began the treatment later experienced a shorter duration of cold sore lesions and a decrease in the symptoms compared with previous episodes. The majority of the patients reported the reduction in the severity of symptoms and the reduction in the recurrence episodes after the lignin-ascorbic acid treatment compared with previous episodes, suggesting its possible applicability for the prevention and treatment of HSV-1 infection.

  8. Evaluating a Community-Partnered Cancer Clinical Trials Pilot Intervention with African American Communities

    PubMed Central

    Green, Melissa A.; Michaels, Margo; Blakeney, Natasha; Odulana, Adebowale A.; Isler, Malika Roman; Richmond, Alan; Long, Debra G.; Robinson, William S.; Taylor, Yhenneko J.; Corbie-Smith, Giselle

    2015-01-01

    Objectives Cancer Clinical Trial (CCT) accrual and retention rates remain disproportionately low among African Americans. Awareness and access to trials are crucial facilitators of trial participation. Strategies developed within a community-based participatory framework (CBPR) are potential solutions to increase awareness and access to CCTs. In this study, we describe the pilot phase of three innovative community-centered modules to improve basic CCT knowledge, awareness of locations to access CCT information, and opportunities to participate in CCTs. Design Four community organizations completed Community Bridges to CCTs training-of-the trainer and recruited adult African American volunteers to participate in one of three CCT education modules: a workshop about CCTs; a role-play describing one person's experience with CCTs; or a call and response session reviewing myths and facts about CCTs. Pre- and post-test surveys were collected and analyzed using McNemar agreement statistic to evaluate changes in knowledge and attitudes regarding trials. Results Trainers enrolled 125 participants in the Call and Response (n=22), Role-play (n=60), and Workshop (n=43) modules. Module participants were mostly African American, female, and mean age of 53 years. Comparison of pre and post-test responses demonstrates favorable changes in awareness of CCTs and where to access to CCTs across the sample. Analysis by module type indicates significant increases for participants in the Call and Response (p < 0.01) and Role-Play modules (p < 0.001), but not the Workshop module. Conclusion Despite measures taken to increase the participation and retention rate of African Americans in clinical trials, little advancement has been made. Developing tailored community education modules on CCTs within the CBPR framework is a promising innovation to increase knowledge about CCTs and favorable attitudes about participation that are known precursors to trial enrollment. PMID:25564207

  9. Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial

    PubMed Central

    Sundberg, Tobias; Petzold, Max; Wändell, Per; Rydén, Anna; Falkenberg, Torkel

    2009-01-01

    relevant difference between groups that was also supported by a small distribution based effect size, i.e. vitality (-7.3 points, Cohen's d -0.34) which was in favour of IM. There was a clinical trend between groups showing that IM contributed to less use of prescription and non-prescription analgesics (-11.7 and - 9.7 percent units respectively) compared to conventional care. Exploring clinically relevant differences and the SF-36 as the basis for a main outcome measure showed that the sample sizes needed per arm to adequately power a full-scale trial depended on the target domain, i.e. ranging from 60 (vitality) to 339 (role emotion). Conclusion This pilot study investigated the implementation of IM in the primary care management of non-specific back and neck pain. Recruiting patients and implementing IM in routine clinical practice was feasible. The results warrant further exploration into different perspectives and relevant combinations of outcome measures including the use of health resources, drugs and cost-effectiveness to help understand the relevance of IM in primary care. Future research should prioritise larger scale studies considering variability, pain duration and small to moderate treatment effects. Trial registration Clinical trials NCT00565942 PMID:19735542

  10. [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.

  11. A prospective study of the clinical content of palliative medicine interdisciplinary team meetings.

    PubMed

    Powazki, Ruth D; Walsh, Declan; Shrotriya, Shiva

    2015-12-01

    Structured interprofessional communication should improve the structure and clarity of the plan of care. The interdisciplinary team meeting (IDTM) is an opportunity for shared information on patients' and family care needs. We report a prospective observations study of palliative medicine IDTM, which recorded the clinical issues discussed. One hundred and forty-five disparate clinical items were identified for 59 patients and were discussed by the IDTM in about 240 minutes. By content analysis and research meeting consensus, they were grouped into 9 agreed interdisciplinary themes. The 9 themes were then subjected to biostatistical analysis and 3 communication clusters identified. Themes consisted of 3 major communication clusters: (1) clinical services, (2) psychosocial, and (3) care plan. Two themes (information exchange and clinical transitions) did not cluster. The IDTM identified patient care need, reported concerns, and supported collaboration in proactive patient care plans. Future research projects with more patients and a large number of meetings can confirm our findings. This should also examine specific contributions by professional discipline.

  12. Is There a Benefit to Drains with a Kocher-Langenbeck Approach? A Prospective Randomized Pilot Study

    DTIC Science & Technology

    2010-11-01

    HO, Kaukonen JP, Salo SA. Drainage is of no use in primary uncomplicated cemented hip and knee arthroplasty for osteoarthritis : a prospective...their posterior wall fractures. One patient had an open fracture with communication between the rectum and the hip joint. All patients underwent open...the frequent presence of damaged and contused muscle about the hip as an additional reason for the use of drains. Closed suction drains cannot be

  13. Using Vascular Quality Initiative as a Platform for Organizing Multicenter, Prospective, Randomized Clinical Trials: OVERPAR Trial

    PubMed Central

    Eslami, Mohammad H.; Doros, Gheorghe; Goodney, Philip P.; Elderup-Jorgenson, Jens; Cronenwett, Jack L.; Malikova, Marina; Farber, Alik

    2014-01-01

    Background We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters’ prospective trials on very modest budget. Methods VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event–free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform. Conclusions Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates. PMID:25311746

  14. In utero Repair of Myelomeningocele: Rationale, Initial Clinical Experience and a Randomized Controlled Prospective Clinical Trial

    PubMed Central

    Danzer, Enrico; Flake, Alan W.

    2008-01-01

    Myelomeningocele (MMC), one of the most common congenital malformations, can result in severe lifelong disabilities, including paraplegia, hydrocephalus, Arnold-Chiari II malformation, incontinence, sexual dysfunction, skeletal deformations, and mental impairment. MMC was the first nonlethal anomaly to be treated by fetal surgery. Studies in animals provide compelling evidence that the primary cause of the neurological deficit associated with MMC is not simply incomplete neurulation but rather chronic mechanical injury and amniotic-fluid-induced chemical trauma that progressively damage the exposed neural tissue during gestation. Initial results suggest that the surgical repair of MMC before 25 weeks of gestation may preserve neurological function, reverse the hindbrain herniation of the Arnold-Chiari II malformation, and obviate the need for postnatal placement of a ventriculoperitoneal shunt. As it is currently unknown whether fetal surgery for MMC is truly beneficial compared to standard postnatal care, a randomized, controlled clinical trial has been initiated within the United States. PMID:22479081

  15. Dendritic cell-based vaccines in treating recurrent herpes labialis: Results of pilot clinical study.

    PubMed

    Leplina, Olga; Starostina, Nataliya; Zheltova, Olga; Ostanin, Alexandr; Shevela, Ekaterina; Chernykh, Elena

    2016-12-01

    Recurrent herpes simplex labialis caused predominantly with herpes simplexvirus 1(HSV-1) is a major problem, for which various treatments have minimal impact. Given the important role of the immune system in controlling virus infection, an activation of virus-specific immune responses, in particular,using dendritic cell (DCs) vaccines, seems to be a promising approach for the treatment of patients with frequent recurrences of herpes labialis. The current paper presents the results of a pilot study of the safety and efficacy of DC vaccines in 14 patients with recurrent HSV-1 infections. DCs were generated in presence of GM-CSF and IFN-alpha and were loaded with HSV-1 recombinant viral glycoprotein D (HSV1gD). DCs cells were injected subcutaneously as 2 courses of vaccination during 9 months. Immunotherapy with DCs did not induce any serious side effects and resulted in more than 2-fold reduction in the recurrence rate and significant enhancement of the inter-recurrent time during the 9 months of treatment and subsequent 6-month follow-up period. An obvious clinical improvement was accompanied with an induction of an antigen-specific response to HCV1gD and a normalization of reduced mitogenic responsiveness of mono-nuclear cells. According to long-term survey data (on average 48 months after the beginning of therapy), 87% of respondents reported the decreased incidence of recurrent infection. At this time, most patients (85.7%) responded to HCV1gD stimulation. The data obtained suggests that dendritic cell vaccines may be a promising new approach for the treatment of recurrent labial herpes.

  16. Metformin in Amnestic Mild Cognitive Impairment: results of a pilot randomized placebo controlled clinical trial

    PubMed Central

    Luchsinger, José A.; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Devangere P.; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (AMCI) with the goal of collecting preliminary data on feasiblity, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with AMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake (rCMRgl) in the posterior cingulate-precuneus in brain Fluorodeoxyglucose Positron Emission Tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty % of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7 ± 8.5 vs. 5.3 ± 8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD. PMID:26890736

  17. Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial

    PubMed Central

    Thompson, Nia; Nazir, Niaman; Cox, Lisa Sanderson; Faseru, Babalola; Goggin, Kathy; Ahluwalia, Jasjit S; Nollen, Nicole L

    2011-01-01

    Background Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials. Objectives To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy. Research design Secondary data analysis of a randomized pilot study. Participants 46 moderate-to-heavy (>10 cigarettes per day) African-American smokers. Main measures Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY) in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded. Results Participants were a mean age of 48 years (SD = 13), predominately female (59%), low income (60% < $1800 monthly family income), and smoked an average of 17 (SD = 7) cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (rs = 0.94, P < 0.001). Participants with discordant counts (n = 7) had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P < 0.0005), but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P < 0.0004) than participants with matching phone and in-person counts (n = 39). Conclusion Unannounced telephone pill counts appear to be a reliable and practical method for measuring adherence to smoking cessation pharmacotherapy. PMID:22003285

  18. Metformin in Amnestic Mild Cognitive Impairment: Results of a Pilot Randomized Placebo Controlled Clinical Trial.

    PubMed

    Luchsinger, José A; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Davangere P; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (aMCI) with the goal of collecting preliminary data on feasibility, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with aMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake in the posterior cingulate-precuneus in brain fluorodeoxyglucose positron emission tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty percent of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7±8.5 versus 5.3±8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD.

  19. A Systemic Review on Aloe arborescens Pharmacological Profile: Biological Activities and Pilot Clinical Trials.

    PubMed

    Singab, Abdel-Naser B; El-Hefnawy, Hala M; Esmat, Ahmed; Gad, Haidy A; Nazeam, Jilan A

    2015-12-01

    Since ancient times, plants and herbal preparations have been used as medicine. Research carried out in the last few decades has verified several such claims. Aloe arborescens Miller, belonging to the Aloe genus (Family Asphodelaceae), is one of the main varieties of Aloe used worldwide. The popularity of the plant in traditional medicine for several ailments (antitumor, immunomodulatory, antiinflammatory, antiulcer, antimicrobial and antifungal activity) focused the investigator's interest on this plant. Most importantly, the reported studies have shown the plant effectiveness on various cancer types such as liver, colon, duodenal, skin, pancreatic, intestinal, lung and kidney types. These multiple biological actions make Aloe an important resource for developing new natural therapies. However, the biological activities of isolated compounds such as glycoprotein, polysaccharides, enzyme and phenolics were insufficient. Considering all these, this contribution provides a systematic review outlining the evidence on the biological efficacy of the plant including the pharmacology and the related mechanisms of action, with specific attention to the various safety precautions, and preclinical and clinical studies, indicating the future research prospects of this plant.

  20. 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.

  1. 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.

  2. The MOTIV-HEART Study: A Prospective, Randomized, Single-Blind Pilot Study of Brief Strategic Therapy and Motivational Interviewing among Cardiac Rehabilitation Patients

    PubMed Central

    Pietrabissa, Giada; Manzoni, Gian Mauro; Rossi, Alessandro; Castelnuovo, Gianluca

    2017-01-01

    Background: Psychological distress, biomedical parameters, and unhealthy lifestyles contribute to a poorer prognosis for cardiac disease. Public health's challenge is to motivate patients to utilize self-care. Objective: This prospective, randomized, single-blind pilot study aimed at testing the incremental efficacy of Brief Strategic Therapy (BST) combined with Motivational Interviewing (MI) in improving selected biomedical and psychological outcomes over and beyond those of the stand-alone BST in a residential Cardiac Rehabilitation (CR) program. Method: Fourty-two inpatients (17 females), enrolled in a 1-month CR program, were randomly allocated into two conditions: (a) Three sessions of BST and (b) Three sessions of BST plus MI. Data were collected at baseline, discharge, and after 3 months through phone interviews. Results: At discharge, no significant between-group difference was found in any outcome variable. Changes from pre- to post-treatment within each condition showed significant improvements only in the BST group, where the level of external regulation diminished, and both the participants' self-regulation (Relative Autonomous Motivation Index, RAI) and willingness to change improved. At the 3-month follow-up, within-group analyses on responders (BST = 9; BST + MI = 11) showed a statistically significant improvement in the level of systolic blood pressure in both groups. Discussion: Findings showed no evidence of the incremental efficacy of combining BST and MI over and beyond BST alone on either selected biomedical or psychological outcomes among CR patients. Conclusions: Ends and limitations from the present pilot study should be considered and addressed in future investigations. PMID:28223950

  3. Arthrocentesis and temporomandibular joint disorders: clinical and radiological results of a prospective study.

    PubMed

    De Riu, Giacomo; Stimolo, Mirella; Meloni, Silvio Mario; Soma, Damiano; Pisano, Milena; Sembronio, Salvatore; Tullio, Antonio

    2013-01-01

    Purpose. We evaluated the efficacy of arthrocentesis in the treatment of temporomandibular joint (TMJ) disorders. Material and Methods. In this prospective clinical case series, 30 consecutive patients with TMJ disorders underwent arthrocentesis using saline and sodium hyaluronate injections. Outcome measures were TMJ pain, maximum mouth opening (MMO), joint noises, and anatomical changes in the TMJ architecture. Patients were evaluated using cone-beam computed tomography (CBCT) and magnetic resonance imaging (MRI) at the beginning of treatment and 60 days after the last arthrocentesis. Pretreatment and posttreatment clinical parameters were compared using paired and unpaired t-tests, and McNemar's test was used to evaluate CBCT and MRI changes (P < 0.05). Results. At 1-year follow-up examinations, visual analogue scale scores indicated that pain was reduced significantly and mean postoperative MMO was increased significantly. CBCT findings showed no significant change, and MRI showed only slight reductions in inflammatory signs. Conclusions. Within the limitations of this study, we can conclude that arthrocentesis is a simple, minimally invasive procedure with a relatively low risk of complications and significant clinical benefits in patients with TMJ disorders. This trial is registered with NCT01903512.

  4. Prospective clinical observational study evaluating gender-associated differences of preoperative pain intensity

    PubMed Central

    Tafelski, Sascha; Kerper, Léonie F; Salz, Anna-Lena; Spies, Claudia; Reuter, Eva; Nachtigall, Irit; Schäfer, Michael; Krannich, Alexander; Krampe, Henning

    2016-01-01

    Abstract Previous studies reported conflicting results concerning different pain perceptions of men and women. Recent research found higher pain levels in men after major surgery, contrasted by women after minor procedures. This trial investigates differences in self-reported preoperative pain intensity between genders before surgery. Patients were enrolled in 2011 and 2012 presenting for preoperative evaluation at the anesthesiological assessment clinic at Charité University hospital. Out of 5102 patients completing a computer-assisted self-assessment, 3042 surgical patients with any preoperative pain were included into this prospective observational clinical study. Preoperative pain intensity (0–100 VAS, visual analog scale) was evaluated integrating psychological cofactors into analysis. Women reported higher preoperative pain intensity than men with median VAS scores of 30 (25th–75th percentiles: 10–52) versus 21 (10–46) (P < 0.001). Adjusted multiple regression analysis showed that female gender remained statistically significantly associated with higher pain intensity (P < 0.001). Gender differences were consistent across several subgroups especially with varying patterns in elderly. Women scheduled for minor and moderate surgical procedures showed largest differences in overall pain compared to men. This large clinical study observed significantly higher preoperative pain intensity in female surgical patients. This gender difference was larger in the elderly potentially contradicting the current hypothesis of a primary sex-hormone derived effect. The observed variability in specific patient subgroups may help to explain heterogeneous findings of previous studies. PMID:27399095

  5. Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency.

    PubMed

    Krleža-Jeriç, Karmela; Lemmens, Trudo; Reveiz, Ludovic; Cuervo, Luis Gabriel; Bero, Lisa Anne

    2011-07-01

    The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.

  6. [Rivaroxaban at Non-Valvular Atrial Fibrillation: a Prospective Study and Clinical Practice].

    PubMed

    Fonyakin, A V

    2016-08-01

    The article presents an analytical review of the results of post-registration clinical studies on the efficacy and safety of rivaroxaban in nonvalvular atrial fibrillation (AF) to prevent stroke and other systemic thromboembolic complications. The main purpose of the first large prospective international observational study of rivaroxaban for stroke prevention in patients with non-valvular AF patients XANTUS was the analysis of efficacy and safety of rivaroxaban in clinical practice. Results of one year of observation of 6784 patients confirmed that rivaroxaban is effective and safe in real unselected population of patients with non-valvular AF and various stroke risk. The first Russian multicenter observational study Neuro-Xar dedicated to secondary prevention of stroke and systemic embolism, demonstrated the efficacy and safety of rivaroxaban in routine clinical practice. Lower risk of fatal intracranial and gastrointestinal bleeding was found in retrospective post-marketing studies, of rivaroxaban in the US, such as the PMSS and REVISIT-US. Rivaroxaban therapy was associated with reduced risk of the combined endpoint (ischemic stroke and intracranial hemorrhage).

  7. Arthrocentesis and Temporomandibular Joint Disorders: Clinical and Radiological Results of a Prospective Study

    PubMed Central

    De Riu, Giacomo; Soma, Damiano; Pisano, Milena; Sembronio, Salvatore; Tullio, Antonio

    2013-01-01

    Purpose. We evaluated the efficacy of arthrocentesis in the treatment of temporomandibular joint (TMJ) disorders. Material and Methods. In this prospective clinical case series, 30 consecutive patients with TMJ disorders underwent arthrocentesis using saline and sodium hyaluronate injections. Outcome measures were TMJ pain, maximum mouth opening (MMO), joint noises, and anatomical changes in the TMJ architecture. Patients were evaluated using cone-beam computed tomography (CBCT) and magnetic resonance imaging (MRI) at the beginning of treatment and 60 days after the last arthrocentesis. Pretreatment and posttreatment clinical parameters were compared using paired and unpaired t-tests, and McNemar's test was used to evaluate CBCT and MRI changes (P < 0.05). Results. At 1-year follow-up examinations, visual analogue scale scores indicated that pain was reduced significantly and mean postoperative MMO was increased significantly. CBCT findings showed no significant change, and MRI showed only slight reductions in inflammatory signs. Conclusions. Within the limitations of this study, we can conclude that arthrocentesis is a simple, minimally invasive procedure with a relatively low risk of complications and significant clinical benefits in patients with TMJ disorders. This trial is registered with NCT01903512. PMID:24319462

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

    PubMed

    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.

  9. Clinical progression and outcome of dysphagia following thermal burn injury: a prospective cohort study.

    PubMed

    Rumbach, Anna F; Ward, Elizabeth C; Cornwell, Petrea L; Bassett, Lynell V; Muller, Michael J

    2012-01-01

    The objectives of this study were 1) to establish clinical profiles of dysphagic and nondysphagic individuals following thermal burn injury and 2) to provide a clinical profile of the progression and outcome of dysphagia resolution by hospital discharge for a dysphagic cohort. A total of 438 consecutively admitted patients with thermal burns were included. All patients underwent a clinical swallowing examination. Medical parameters regarding burn presentation and its treatment and speech-language pathology specific variables from admission to discharge were collected for each participant. Dysphagia was identified in 49 patients via clinical assessment, and their course of recovery was followed up until the point of dysphagia resolution or discharge. No significant difference was observed between the dysphagic and nondysphagic groups in age, gender, and injury etiology. However, the dysphagic cohort was significantly different from the nondysphagic group in all variables pertaining to injury presentation and medical management. Individuals with dysphagia took significantly longer to start, and maintain, oral intake and required nonoral supplementation for three and a half times longer than those who were nondysphagic. Length of speech-language pathology intervention averaged 1 month for the dysphagics and increased with dysphagia severity. Return to normal fluid consistencies occurred in >75% of dysphagic individuals by week 7 after injury, although resumption of normal diet textures was more protracted, with 75% resuming normal oral intake by week 9. Dysphagia had resolved in 50% of the cohort by week 6, and by hospital discharge, 85% of the dysphagic individuals had resumed normal oral intake of thin fluids and a general diet. This is the first large prospective cohort study to establish clinical profiles of dysphagic and nondysphagic cohorts and document the nature of dysphagia and patterns of recovery within the thermal burn population. These current data will

  10. A prospective study of neuropathic pain induced by thoracotomy: incidence, clinical description, and diagnosis.

    PubMed

    Guastella, Virginie; Mick, Gérard; Soriano, Christophe; Vallet, Laurent; Escande, Georges; Dubray, Claude; Eschalier, Alain

    2011-01-01

    This study evaluated prospectively the incidence of neuropathic pain after thoracotomy, described its clinical characteristics, and delineated landmarks for its diagnosis in daily practice. We evaluated clinically painful symptoms and sensory deficits in 54 patients after lateral/posterolateral thoracotomy for broncho-pulmonary carcinoma with standardized surgical and analgesic procedures. At 2months, 49 patients suffered from non malignant thoracic pain, and at 6months 38 patients (loss to follow-up for 7) reported persisting pain. In 35 patients, painful symptoms and sensory deficits could be evaluated using a standardized clinical bedside procedure. According to the grading system proposed by Treede et al. [41], neuropathic pain was considered probable in 21 patients, while use of the DN4 questionnaire concluded that neuropathic pain was probable in 17 patients. The two diagnostic procedures provided similar conclusions in 16 patients. Morphine consumption during the early post-operative period (mean 111.3±30.8mg/day) and pain intensity (VAS: mean 5.71±2.1) were significantly higher in patients suffering from neuropathic pain than in other patients with pain (mean 80±21.4mg/day; VAS: mean 3.9±2.4). The clinical picture in most patients with neuropathic pain included electric shocks and severe multimodal hypoesthesia in the sensory area of 5th/6th intercostal nerves. Thus, our results indicate a minimal incidence of chronic post-thoracotomy pain at 70% and that of neuropathic pain at 29%, this latter being clinically suggested by a combination of certain symptoms and reinforced by the DN4 questionnaire when sensory deficit at scar is present.

  11. Antifungal Lock Therapy with Liposomal Amphotericin B: A Prospective Trial.

    PubMed

    McGhee, William; Michaels, Marian G; Martin, Judith M; Mazariegos, George V; Green, Michael

    2016-03-01

    We conducted a prospective pilot study to evaluate the potential role of combined systemic antifungal and liposomal amphotericin B lock therapy in children with intestinal insufficiency with fungal catheter-related bloodstream infections whose central venous catheters had not been removed. Our results provide supportive evidence for the conduct of larger clinical trials to confirm the efficacy and safety of this approach.

  12. Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

    PubMed

    Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

    2015-04-01

    Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream.

  13. Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study

    PubMed Central

    Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

    2016-01-01

    Objectives The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. Methods A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Results Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Conclusion Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients. PMID:27093294

  14. A daily-life-oriented intervention to improve prospective memory and goal-directed behaviour in ageing: a pilot study.

    PubMed

    Burkard, Christina; Rochat, Lucien; Blum, Anaëlle; Emmenegger, Joëlle; Juillerat Van der Linden, Anne-Claude; Van der Linden, Martial

    2014-01-01

    Difficulties in the execution of goal-directed behaviours, and particularly their prospective memory component, can arise in ageing and have important consequences for autonomy. The first objective of this article is to present an intervention that trained older individuals who reported prospective memory or goal-directed behaviour problems to use "implementation intentions". This technique, which has been shown to improve different aspects of goal-directed behaviour enactment, consists of establishing a mental (verbal and/or visual) link between the action that must be performed and the situation in which it must be performed. Our programme proposes exercises of progressively increasing difficulty that are targeted at daily life situations. Our second objective was to test the programme in small groups of older adults. Preliminary data regarding the programme's feasibility and its initial efficacy show a significant improvement in the main outcome measure, a questionnaire assessing goal-directed behaviours in everyday life. The participants also reported being significantly less bothered by their difficulties, although there were no significant changes in quality of life, self-esteem, anxiety or depression. Two participants with different psychological profiles, who benefited differently from the intervention, are then presented in more detail.

  15. 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

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

    PubMed

    Plasseraud, Kristen Meldi; Cook, Robert W; 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).

  17. 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

  18. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    PubMed

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  19. Hepatitis-C prevalence in an urban native-American clinic: a prospective screening study.

    PubMed Central

    Neumeister, Amy S.; Pilcher, LaVada E.; Erickson, Judi M.; Langley, Lora L.; Murphy, Mary M.; Haukaas, Nicole M.; Mailliard, Mark E.; Larsen, Jennifer L.

    2007-01-01

    BACKGROUND: Native-American populations are disproportionately burdened by chronic liver disease, and the prevalence of hepatitis C (HCV) in native Americans is unknown. PURPOSE: To determine the prevalence of hepatitis C in a local native-American population via a prospective screening study. PROCEDURES: Two-hundred-forty-three native Americans (161 females/82 males) using an urban clinic and representing > 30 tribes from across the United States were screened. Mean age was 41 +/- 1 years. Hepatitis-C screening was by anti-HCV with confirmation by HCV RNA. A questionnaire assessed potential risk factors for HCV. FINDINGS: Anti-HCV antibodies were found in 11.5% (95% CI: 7.5-15.5%). HCV RNA was present by polymerase chain reaction (PCR) in 8.6% (95% CI: 5.1-12.1%) and was more common in males [13.4% (95% CI: 6.0-20.8%)] than females [6.2% (95% CI: 2.5-9.9%)]. The most common potential risk factors for chronic HCV infection were intravenous (IV) drug or cocaine use (p < 0.0001), tattoos > 5 years old (p < 0.0001) and having a sexual partner with HCV (p = 0.0063). CONCLUSION: HCV prevalence is higher in an urban native-American clinic population than reported in the general U.S. population. Use of IV drugs is the most prevalent risk factor, but tattoos and sexual transmission may also be important. PMID:17444428

  20. Effects of Korean red ginseng as an adjuvant to bile acids in medical dissolution therapy for gallstones: a prospective, randomized, controlled, double-blind pilot trial.

    PubMed

    Lee, Jun Kyu; Kang, Hyoun Woo; Kim, Jae Hak; Lim, Yun Jeong; Koh, Moon-Soo; Lee, Jin Ho

    2013-01-01

    Although ginseng, the root of Panax quinquefolium and P. ginseng, was reported to have anti-cholelithogenic effects in animal experiments, there have, to date, been no human studies. We conducted this prospective, controlled, double-blind pilot trial to evaluate the safety and efficiency of Korean red ginseng (KRG), the steamed root of P. ginseng C.A. Meyer. Twenty eight consecutive patients were randomized to receive either KRG (7.5 g divided into three daily doses) or a placebo as an adjuvant to the standard regimen of bile acids for gallstones (500 mg of chenodeoxycholic acid and 500 mg of ursodeoxycholic acid divided into three daily doses) for 24 weeks. No case of serious adverse reaction occurred in both groups. Although the decrease in stone burden was larger in the KRG group (3.4 ± 0.6 ml3) than in the placebo group (2.3 ± 1.1 ml(3)), it did not reach statistical significance (p = 0.09). Also there were no differences in the rate of complete dissolution, subjective improvement in symptoms, and the rate of cholecystectomy due to worsening pain or the development of complications and changes in laboratory tests before and after treatment. In conclusion, the addition of KRG as an adjuvant was safe for patients undergoing bile acid dissolution therapy for gallstones although it did not affect the results. Large-scaled trials to optimize regimens are expectantly needed.

  1. Endoscopic third ventriculostomy in children: prospective, multicenter results from the Hydrocephalus Clinical Research Network.

    PubMed

    Kulkarni, Abhaya V; Riva-Cambrin, Jay; Holubkov, Richard; Browd, Samuel R; Cochrane, D Douglas; Drake, James M; Limbrick, David D; Rozzelle, Curtis J; Simon, Tamara D; Tamber, Mandeep S; Wellons, John C; Whitehead, William E; Kestle, John R W

    2016-10-01

    OBJECTIVE Endoscopic third ventriculostomy (ETV) is now established as a viable treatment option for a subgroup of children with hydrocephalus. Here, the authors report prospective, multicenter results from the Hydrocephalus Clinical Research Network (HCRN) to provide the most accurate determination of morbidity, complication incidence, and efficacy of ETV in children and to determine if intraoperative predictors of ETV success add substantially to preoperative predictors. METHODS All children undergoing a first ETV (without choroid plexus cauterization) at 1 of 7 HCRN centers up to June 2013 were included in the study and followed up for a minimum of 18 months. Data, including detailed intraoperative data, were prospectively collected as part of the HCRN's Core Data Project and included details of patient characteristics, ETV failure (need for repeat hydrocephalus surgery), and, in a subset of patients, postoperative complications up to the time of discharge. RESULTS Three hundred thirty-six eligible children underwent initial ETV, 18.8% of whom had undergone shunt placement prior to the ETV. The median age at ETV was 6.9 years (IQR 1.7-12.6), with 15.2% of the study cohort younger than 12 months of age. The most common etiologies were aqueductal stenosis (24.8%) and midbrain or tectal lesions (21.2%). Visible forniceal injury (16.6%) was more common than previously reported, whereas severe bleeding (1.8%), thalamic contusion (1.8%), venous injury (1.5%), hypothalamic contusion (1.5%), and major arterial injury (0.3%) were rare. The most common postoperative complications were CSF leak (4.4%), hyponatremia (3.9%), and pseudomeningocele (3.9%). New neurological deficit occurred in 1.5% cases, with 0.5% being permanent. One hundred forty-one patients had documented failure of their ETV requiring repeat hydrocephalus surgery during follow-up, 117 of them during the first 6 months postprocedure. Kaplan-Meier rates of 30-day, 90-day, 6-month, 1-year, and 2-year failure

  2. 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

  3. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

    PubMed Central

    Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-01-01

    Background Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow

  4. Olfactory Mucosa Autografts in Human Spinal Cord Injury: A Pilot Clinical Study

    PubMed Central

    Lima, Carlos; Pratas-Vital, José; Escada, Pedro; Hasse-Ferreira, Armando; Capucho, Clara; Peduzzi, Jean D

    2006-01-01

    Background/Objective: Olfactory mucosa is a readily accessible source of olfactory ensheathing and stem-like progenitor cells for neural repair. To determine the safety and feasibility of transplanting olfactory mucosa autografts into patients with traumatically injured spinal cords, a human pilot clinical study was conducted. Methods: Seven patients ranging from 18 to 32 years of age (American Spinal Injury Association [ASIA] class A) were treated at 6 months to 6.5 years after injury. Olfactory mucosa autografts were transplanted into lesions ranging from 1 to 6 cm that were present at C4–T6 neurological levels. Operations were performed from July 2001 through March 2003. Magnetic resonance imaging (MRI), electromyography (EMG), and ASIA neurological and otolaryngological evaluations were performed before and after surgery. Results: MRI studies revealed moderate to complete filling of the lesion sites. Two patients reported return of sensation in their bladders, and one of these patients regained voluntary contraction of anal sphincter. Two of the 7 ASIA A patients became ASIA C. Every patient had improvement in ASIA motor scores. The mean increase for the 3 subjects with tetraplegia in the upper extremities was 6.3 ± 1.2 (SEM), and the mean increase for the 4 subjects with paraplegia in the lower extremities was 3.9 ± 1.0. Among the patients who improved in their ASIA sensory neurological scores (all except one patient), the mean increase was 20.3 ± 5.0 for light touch and 19.7 ± 4.6 for pinprick. Most of the recovered sensation below the initial level of injury was impaired. Adverse events included sensory decrease in one patient that was most likely caused by difficulty in locating the lesion, and there were a few instances of transient pain that was relieved by medication. EMG revealed motor unit potential when the patient was asked to perform movement. Conclusion: This study shows that olfactory mucosa autograft transplantation into the human injured

  5. A Clinical Outcome-Based Prospective Study on Venous Thromboembolism After Cancer Surgery

    PubMed Central

    Agnelli, Giancarlo; Bolis, Giorgio; Capussotti, Lorenzo; Scarpa, Roberto Mario; Tonelli, Francesco; Bonizzoni, Erminio; Moia, Marco; Parazzini, Fabio; Rossi, Romina; Sonaglia, Francesco; Valarani, Bettina; Bianchini, Carlo; Gussoni, Gualberto

    2006-01-01

    Summary Background Data: The epidemiology of venous thromboembolism (VTE) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis (DVT). However, the clinical relevance of asymptomatic venography-detected DVT is unclear, and the population of these clinical trials is not necessarily representative of the overall cancer surgery population. Objective: The aim of this study was to evaluate the incidence of clinically overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE. Methods: @RISTOS was a prospective observational study in patients undergoing general, urologic, or gynecologic surgery. Patients were assessed for clinically overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days. All outcome events were evaluated by an independent Adjudication Committee. Results: A total of 2373 patients were included in the study: 1238 (52%) undergoing general, 685 (29%) urologic, and 450 (19%) gynecologic surgery. In-hospital prophylaxis was given in 81.6% and postdischarge prophylaxis in 30.7% of the patients. Fifty patients (2.1%) were adjudicated as affected by clinically overt VTE (DVT, 0.42%; nonfatal pulmonary embolism, 0.88%; death 0.80%). The incidence of VTE was 2.83% in general surgery, 2.0% in gynecologic surgery, and 0.87% in urologic surgery. Forty percent of the events occurred later than 21 days from surgery. The overall death rate was 1.72%; in 46.3% of the cases, death was caused by VTE. In a multivariable analysis, 5 risk factors were identified: age above 60 years (2.63, 95% confidence interval, 1.21–5.71), previous VTE (5.98, 2.13–16.80), advanced cancer (2.68, 1.37–5.24), anesthesia lasting more than 2 hours (4.50, 1.06–19.04), and bed rest longer than 3 days (4.37, 2.45–7.78). Conclusions: VTE remains a common complication of cancer surgery, with a remarkable proportion

  6. One-step surgical placement of Brånemark implants: a prospective multicenter clinical study.

    PubMed

    Becker, W; Becker, B E; Israelson, H; Lucchini, J P; Handelsman, M; Ammons, W; Rosenberg, E; Rose, L; Tucker, L M; Lekholm, U

    1997-01-01

    This prospective longitudinal multicenter study evaluated the clinical outcomes after placement and restoration of one-step Brånemark implants into the maxillae and mandibles of completely and partially edentulous patients. Six surgical treatment centers participated in this study, in which 135 implants were placed into 63 adult patients. All implants were stable after placement. The majority of implants were placed into type B bone with minimal jaw resorption and type 2 bone quality. After implant placement, standard transmucosal healing abutments were firmly placed. The average amount of time between implant placement and prosthetic abutment connection was 170 days in the maxillae and 147 days in the mandibles. To evaluate crestal bone changes caused by implant placement, a periodontal probe was used to measure midbuccally from the top of the implant cylinder to the alveolar crest; in 29 patients, 54 midbuccal bone crest sites were remeasured following prosthetic abutment connection. Crestal bone changes in mandibles and maxillae were statistically and clinically insignificant. Six implants were lost prior to loading and one implant has not been restored. No implants or restorations were lost after loading. At 1 year, the implant success rate was 95.6%. Mesiodistal radiographic measurements from 34 patients were averaged, and changes from prosthetic abutment connection to, on average, 12 months follow-up were compared. The radiographs, which were digitalized, measured from the bottom of the implant cylinder to the most coronal bone in contact with implant thread. For mandibular implants, the mean radiographic bone level at prosthetic abutment connection was 1.07 mm; after loading, it was 1.35 mm. For maxillary implants, the mean radiographic bone height at prosthetic abutment connection was 1.16 mm; after loading, it was 1.36 mm. These changes were not statistically significant. The 1-year outcomes from this patient series indicate that one-step Br

  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. 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.

  9. A prospective double-blinded comparative analysis of framycetin and silver sulphadiazine as topical agents for burns: a pilot study.

    PubMed

    Ahuja, Rajeev B; Gupta, Amit; Gur, Renu

    2009-08-01

    Burn wound sepsis remains the leading cause of mortality if conservative methods of wound management are employed. Topical agents are still the mainstay of such wound management in the developing world. Non availability of agents like Mafenide or silver ion dressings in the developing world due to corporate strategies or cost concerns necessitates a search for alternatives to silver sulphadiazine, which is the gold standard. We report the use of framycetin 1% cream (Soframycin) in 20 patients of major burns (ranging from 15% to 40% TBSA), and in a double blinded study quantitatively comparing the bacterial load on day 4 and day 7 with a group of similar patients in whom silver sulphadiazine was used. The age group of the 40 patients was 10-50 years and they were without any co-morbid condition. All bacterial isolates from the 40 patients were also tested for framycetin sensitivity. Serial kidney function tests were done on all patients, and patients in the framycetin group underwent an audiometric testing at a mean time of 28 days. All results were statistically analyzed. It was noted that there was no statistically significant difference in the colony counts on days 4 and 7 between the two groups. As a corollary, it was also evident that there was no statistically significant difference in the rise in colony counts from day 4 to day 7 in the two groups. Sixty-four percent of all bacterial isolates were sensitive to framycetin, although, this could not be compared with sensitivity to silver sulphadiazine. It was not possible to do assays for framycetin levels in blood but no patient developed nephrotoxicity or ototoxicity with its use. According to our pilot study results framycetin appears to be an alternative to silver suphadiazine as a topical agent for major burns. Framycetin application is also painless and it leads to no discoloration of the wound.

  10. A Pilot Study on the Effect of Angiotensin Receptor Blockers on Platelet Aggregation in Hypertensive Patients- A Prospective Observational Study

    PubMed Central

    Sanji, Narendranath; Kamath, Pallavi Mahadeva; Devendrappa, Srinivas Lokikere; Hanumanthareddy, Shashikala Gowdara; Maniyar, Imran; Rudrappa, Suresh Surappla

    2016-01-01

    Introduction Thrombosis is an invariable component contributing to cardiovascular events in patients with hypertension. One of the risk factors of cardiovascular disease is increased platelet activity. One among the widely used antihypertensive agents are Angiotensin II type 1 Receptor Blockers (ARBs). Even though there are many studies involving antihypertensive agents, their antithrombotic properties remain elusive and not fully characterized. Aim To evaluate the anti-aggregatory effect of ARBs on platelets in-vivo. Materials and Methods A total of 60 subjects were included in this observational pilot study conducted in the medicine out patient department of JJM Hospital, Davanagere, Karnataka, India. Among them, 30 patients with essential hypertension attending Medicine OPD of a tertiary care hospital, who were on ARB for at least one month, were enrolled into study group. The control group consisted of 30 normotensive subjects who were not on any drug affecting platelet function. The Bleeding Time (BT) was evaluated for both the groups using Duke method of BT estimation. Data was analysed using SPSS software version 20. The test group was compared with control group using student’s unpaired t-test. Results The mean BT of study group was 2.488 minutes ± 0.0361 Standard Error of Mean (SEM) and that of control group was 1.998 minutes ± 0.0362 SEM. The result was statistically significant (p<0.001). The average duration of treatment was 2.933 years. Conclusion ARB have antiplatelet activity. Increase in BT in ARB group when compared with that of control group is a reflection of antiplatelet activity. PMID:28050394

  11. Using touch-screen technology to assess smoking in a low-income primary care clinic: a pilot study.

    PubMed

    Smith, Philip H; Homish, Gregory G; Barrick, Christopher; Grier, Nancy L

    2011-01-01

    This pilot study examined the use of a touch-screen tablet personal computer to assess smoking and alcohol use among low-income primary care patients (N = 100) and tested cross-method consistency with a paper assessment. Data were collected in 2009. A touch-screen survey assessed smoking, alcohol use, partner smoking, and acceptability. A separate paper survey assessed smoking, partner smoking, and acceptability. The touch-screen assessment was highly acceptable and reliable. Implications and limitations are noted. Future research should explore the use of touch-screen technology for clinical endeavors requiring a quick assessment of substance use. There was no outside funding for this study.

  12. Clinical trials for drug approval: a pilot study of the view of doctors at Tokushima University Hospital.

    PubMed

    Yanagawa, Hiroaki; Nishiya, Masako; Miyamoto, Toshiko; Shikishima, Michiyo; Imura, Mitsuko; Nakanishi, Rika; Ariuchi, Kazuyo; Akaishi, Akiyo; Takai, Shigemi; Abe, Shinji; Kisyuku, Masatoshi; Kageyama, Chieko; Sato, Chiho; Yamagami, Makiko; Urakawa, Noriko; Sone, Saburo; Irahara, Minoru

    2006-08-01

    The development of new and useful pharmaceutical drugs is essential in order to improve the quality of drug therapeutics. Clinical trials play a central role in drug development. Over time, the clinical trial infrastructure has improved and is now integrating the contribution of clinical research coordinators (CRC). Nevertheless, the attitude of doctors towards clinical trials still favors conventional/historical methodologies. In the present study, we explored the view of doctors towards clinical trials for drug development, in order to improve communication among participants, sponsors, and investigators.A questionnaire was designed for this pilot study. The questionnaire included general attitudes, difficult points, the benefit of doctors in participating as investigators, special attention requirements, and the expected role of CRC in clinical trials for drug approval. In addition, the appropriate use of the outpatient clinic was examined. The questionnaire was provided to doctors in each department of Tokushima University Hospital in 2000 and 2004. Because of the small number of subjects included in this pilot study, no statistical analysis is presented. A total of 89 (81%) and 62 (56%) doctors among 110 responded to the survey in 2000 and 2004, respectively. Inquiries about the familiarity of the physicians with clinical trials for drug approval revealed that 84% in 2000 and 66% in 2004 were aware of such trials. The attitude towards participating as investigators in the clinical trials was favorable, with a response of 66% in 2000 and 58% in 2004. Patients' refusal and the informed consent process were considered difficult areas by many doctors. Expected roles of CRC included activities based on the nurse's specialty. Although many doctors agreed to take care of the study participants separately from the clinical practice, they lacked the time to do so. In spite of the doctors' workload reduction by introduction of the CRC concept, their views regarding

  13. Clinical characteristics of patients with motor disability due to conversion disorder: a prospective control group study

    PubMed Central

    Binzer, M.; Andersen, P.; Kullgren, G.

    1997-01-01

    OBJECTIVES—Previous studies have suggested associations between conversion and many different clinical characteristics. This study investigates these findings in a prospective design including a control group.
METHODS—Thirty consecutive patients with a recent onset of motor disability due to a conversion disorder were compared with a control group of patients with corresponding motor symptoms due to a definite organic lesion. Both groups had a similar duration of symptoms and a comparable age and sex profile and were assessed on a prospective basis. Background information about previous somatic and psychiatric disease was collected and all patients were assessed by means of a structured clinical interview linked to the diagnostic system DSM III-R, the Hamilton rating depression scale, and a special life events inventory.
RESULTS—The conversion group had a higher degree of psychopathology with 33% of the patients fulfilling the criteria for psychiatric syndromes according to DSM-III-R axis I, whereas 50% had axis II personality disorders compared with 10% and 17% respectively in the control group. Conversion patients also had significantly higher scores according to the Hamilton rating depression scale. Although patients with known neurological disease were not included in the conversion group, a concomitant somatic disorder was found in 33% of the patients and 50% complained of benign pain. The educational background in conversion patients was poor with only 13% having dropped out of high school compared with 67% in the control group. Self reported global assessment of functioning according to the axis V on DSM IV was significantly lower in conversion patients, who also registered significantly more negative life events before the onset of symptoms than controls. Logistic regression analysis showed that low education, presence of a personality disorder, and high Hamilton depression score were significantly associated with conversion disorder

  14. 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

  15. Multimodal navigated skull base tumor resection using image-based vascular and cranial nerve segmentation: A prospective pilot study

    PubMed Central

    Dolati, Parviz; Gokoglu, Abdulkerim; Eichberg, Daniel; Zamani, Amir; Golby, Alexandra; Al-Mefty, Ossama

    2015-01-01

    Background: Skull base tumors frequently encase or invade adjacent normal neurovascular structures. For this reason, optimal tumor resection with incomplete knowledge of patient anatomy remains a challenge. Methods: To determine the accuracy and utility of image-based preoperative segmentation in skull base tumor resections, we performed a prospective study. Ten patients with skull base tumors underwent preoperative 3T magnetic resonance imaging, which included thin section three-dimensional (3D) space T2, 3D time of flight, and magnetization-prepared rapid acquisition gradient echo sequences. Imaging sequences were loaded in the neuronavigation system for segmentation and preoperative planning. Five different neurovascular landmarks were identified in each case and measured for accuracy using the neuronavigation system. Each segmented neurovascular element was validated by manual placement of the navigation probe, and errors of localization were measured. Results: Strong correspondence between image-based segmentation and microscopic view was found at the surface of the tumor and tumor-normal brain interfaces in all cases. The accuracy of the measurements was 0.45 ± 0.21 mm (mean ± standard deviation). This information reassured the surgeon and prevented vascular injury intraoperatively. Preoperative segmentation of the related cranial nerves was possible in 80% of cases and helped the surgeon localize involved cranial nerves in all cases. Conclusion: Image-based preoperative vascular and neural element segmentation with 3D reconstruction is highly informative preoperatively and could increase the vigilance of neurosurgeons for preventing neurovascular injury during skull base surgeries. Additionally, the accuracy found in this study is superior to previously reported measurements. This novel preliminary study is encouraging for future validation with larger numbers of patients. PMID:26674155

  16. A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

    PubMed Central

    Toscano, I. L.; Rezende, M.V.; Mello, L. F.; Pires, L.; Paulillo, D.; Glina, S.

    2016-01-01

    ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week). Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5) score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019) and 50.4° and 42.08° before and after verapamil, respectively (p=0.012). The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23) in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58). In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine. PMID:24893912

  17. Clinical features and inflammatory markers in pediatric pneumonia: a prospective study.

    PubMed

    Berg, Are Stuwitz; Inchley, Christopher Stephen; Fjaerli, Hans Olav; Leegaard, Truls Michael; Lindbaek, Morten; Nakstad, Britt

    2017-03-09

    In this prospective, observational study on previously healthy children <18 years, we aimed to study the diagnostic ability of clinical features and inflammatory markers to (i) predict pathologic chest radiography in suspected pneumonia and (ii) differentiate etiology in radiological proven pneumonia. In 394 cases of suspected pneumonia, 265 (67%) had radiographs consistent with pneumonia; 34/265 had proof of bacterial etiology. Of the cases, 86.5% had received pneumococcal conjugate vaccine. In suspected pneumonia, positive chest radiography was significantly associated with increasing C-reactive protein (CRP) values, higher age, and SpO2 ≤92% in multivariate logistic regression, OR 1.06 (95% CI 1.03 to 1.09), OR 1.09 (95% CI 1.00 to1.18), and OR 2.71 (95% CI 1.42 to 5.18), respectively. In proven pneumonia, bacterial pneumonia was significantly differentiated from viral/atypical pneumonia by increasing CRP values and SpO2 >92% in multivariate logistic regression, OR 1.09 (95% CI 1.05 to 1.14) and OR 0.23 (95% CI 0.06 to 0.82), respectively. Combining high CRP values (>80 mg/L) and elevated white blood cell (WBC) count provided specificity >85%, positive likelihood ratios >3, but sensitivity <46% for both radiographic proven and bacterial pneumonia.

  18. Translating ocular biomechanics into clinical practice: current state and future prospects.

    PubMed

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

    2015-01-01

    Biomechanics is the study of the relationship between forces and function in living organisms and 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 the 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.

  19. 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.

  20. Spinal epidural abscess: aetiology, predisponent factors and clinical outcomes in a 4-year prospective study.

    PubMed

    Zimmerer, Stephan M E; Conen, Anna; Müller, Andreas A; Sailer, Martin; Taub, Ethan; Flückiger, Ursula; Schwenzer-Zimmerer, Katja C

    2011-12-01

    Spinal epidural abscess (SEA) is a rare, but serious, condition with multiple causes. We prospectively studied the aetiology, predisposing factors, and clinical outcomes of SEA in all patients with SEA treated in our hospital's neurosurgical service from 2004 to 2008. For each patient, we recorded the medical history, comorbidities, focus of infection, pathogen(s), and outcome. The 36 patients (19 women and 17 men) ranged in age from 34 to 80 years old (mean 57; median 56). The SEA was primary (i.e., due to haematogenous spread) in 16 patients (44%); it was secondary to elective spinal procedures, either injections or surgery, in 20 patients (56%). The duration of follow-up was 12-60 months (mean 36; median 37.5). The most common pathogen, Staphylococcus aureus, was found in 18 patients (50%). Patients with primary SEA had different underlying diseases and a wider range of pathogens than those with secondary SEA. Only five patients (14%) had no major comorbidity; 16 of the 20 patients with secondary SEA (44% of the overall group) had undergone spinal surgery before developing the SEA; the treatment of the SEA involved multiple surgical operations in all 16 of these patients, and spinal instrumentation in 5 (14%); 22 patients (61% of the overall group) recovered fully.

  1. 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

  2. Determinants of the clinical expression of amoxicillin-clavulanate hepatotoxicity: a prospective series from Spain.

    PubMed

    Lucena, M Isabel; Andrade, Raúl J; Fernández, M Carmen; Pachkoria, Ketevan; Pelaez, Gloria; Durán, José A; Villar, Macarena; Rodrigo, Luis; Romero-Gomez, Manuel; Planas, Ramón; Barriocanal, Anabel; Costa, Joan; Guarner, Carlos; Blanco, Sonia; Navarro, José M; Pons, Fernando; Castiella, Agustin; Avila, Susana

    2006-10-01

    Amoxicillin-clavulanate (AC) hepatotoxicity has been reported to exhibit a higher predominance of cholestatic types of damage, especially in males. However, the determinants of its clinical expression are unknown. This study prospectively evaluated the profile of AC hepatotoxicity. Data on all cases of hepatotoxicity reported to the Spanish Registry attributed to AC and assessed as definite or probable on the Council for International Organizations of Medical Sciences (CIOMS) scale were collated and compared to published case series. Hepatotoxicity related to amoxicillin-clavulanate was identified in 69 patients (36 males; mean age 56 years) representing 14% of all cases of hepatotoxicity submitted to the Registry. There was an overall sex distribution and the predominant pattern of lesion was hepatocellular (36%) which occurred at a shorter duration of treatment (P < .03). Mean time lapse between therapy initiation and jaundice onset was 16 days. Late onset of symptoms following end of treatment occurred in half the cases. Multiple logistic regression analysis identified advancing age as the factor associated with the development of cholestatic/mixed type of injury (odds ratio for an age interval for 1 year: 1.045 [95% CI = 1.013-1.078; P = .005). An unfavorable outcome was seen in 7% of patients. In conclusion, age is the most important determinant in the biochemical expression of AC hepatotoxicity; younger age is associated with cytolytic damage and shorter treatment duration, whereas cholestatic/mixed type of damage is related to older age and prolonged AC therapy.

  3. 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.

  4. 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

  5. Headaches precipitated by cough, prolonged exercise or sexual activity: a prospective etiological and clinical study.

    PubMed

    Pascual, Julio; González-Mandly, Andrés; Martín, Rubén; Oterino, Agustín

    2008-10-01

    Headaches provoked by cough, prolonged physical exercise and sexual activity have not been studied prospectively, clinically and neuroradiologically. Our aim was to delimitate characteristics, etiology, response to treatment and neuroradiological diagnostic protocol of those patients who consult to a general Neurological Department because of provoked headache. Those patients who consulted due to provoked headaches between 1996 and 2006 were interviewed in depth and followed-up for at least 1 year. Neuroradiological protocol included cranio-cervical MRI for all patients with cough headache and dynamic cerebrospinal functional MRI in secondary cough headache cases. In patients with headache provoked by prolonged physical exercise or/and sexual activity cranial neuroimaging (CT and/or MRI) was performed and, in case of suspicion of subarachnoid bleeding, angioMRI and/or lumbar tap were carried out. A total of 6,412 patients consulted due to headache during the 10 years of the study. The number of patients who had consulted due to any of these headaches is 97 (1.5% of all headaches). Diagnostic distribution was as follows: 68 patients (70.1%) consulted due to cough headache, 11 (11.3%) due to exertional headache and 18 (18.6%) due to sexual headache. A total of 28 patients (41.2%) out of 68 were diagnosed of primary cough headache, while the remaining 40 (58.8%) had secondary cough headache, always due to structural lesions in the posterior fossa, which in most cases was a Chiari type I malformation. In seven patients, cough headache was precipitated by treatment with angiotensin-converting enzyme inhibitors. As compared to the primary variety, secondary cough headache began earlier (average 40 vs. 60 years old), was located posteriorly, lasted longer (5 years vs. 11 months), was associated with posterior fossa symptoms/signs and did not respond to indomethacin. All those patients showed difficulties in the cerebrospinal fluid circulation in the foramen magnum region

  6. The clinical characteristics of sarcoid arthropathy based on a prospective cohort study

    PubMed Central

    Kobak, Senol; Sever, Fidan; Usluer, Ozan; Goksel, Tuncay; Orman, Mehmet

    2016-01-01

    Background: Sarcoidosis is known as a Th1-mediated disease, which can mimic many primary rheumatologic diseases or sometimes co-exist with them. Clinical characteristics of sarcoid arthropathy are not well described and the studies reported in the literature so far are mostly based on data from referrals. The aim of this study was to evaluate the incidence and clinical characteristics of sarcoid arthropathy. Methods: All our patients were prospectively evaluated in our rheumatology outpatient center from 2011 to 2015. A total of 114 (32 male) patients with sarcoidosis who were admitted to our clinic were included in the study. Clinical, demographical, laboratory, radiological and histological data of these patients obtained during 4-year follow-up and treatment period were compiled and analyzed. Results: The mean patient age was 48.1 years (range, 20–82 years), and the mean disease duration was 40.5 months (range, 1–300 months). Sarcoid arthritis was observed in 71 (62.3%), and arthralgia in 106 (92.9%) patients. Out of the 71 patients with arthritis, 61 (85.9%) had involvement of ankle, 7 (9.8%) knee, 2 (2.8%) wrist, MCP and PIP joints, and 1 (1.4%) had shoulder periarthritis. Oligoarthritis (two to four joints) was the most common pattern followed by monoarthritis and polyarthritis. Arthritis and erytjhema nodosum and arthritis and female sex was found to be correlated (p = 0.03 and p = 0.001). Again, in patients with arthritis, even higher levels of CRP/ESR as well as ANA and RF positivity were observed (p = 0.03, p = 0.01, p = 0.01, and p = 0.02, respectively). A total of 11 patients had another rheumatic pathology concurrent with sarcoidosis. Conclusions: Inflammatory arthritis occurs in a majority of patients with sarcoidosis. Acute arthritis with bilateral ankle involvement is the most common pattern of sarcoid arthropathy. Sarcoidosis can mimic many primary rheumatic diseases or may coexist with them. Sarcoidosis should be considered not only as a

  7. 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.

  8. Efficacy of revascularization to induce apexification/apexogensis in infected, nonvital, immature teeth: a pilot clinical study.

    PubMed

    Shah, Naseem; Logani, Ajay; Bhaskar, Uday; Aggarwal, Vivek

    2008-08-01

    Endodontic treatment options for immature, nonvital teeth conventionally include surgical endodontics, apexification with calcium hydroxide, or single visit mineral trioxide aggregate plug. A new treatment option of revascularization has recently been introduced. It involves disinfecting the root canal system, providing a matrix of blood clot into which cells could grow, and sealing of the coronal access. The present pilot clinical study was undertaken to evaluate the efficacy of revascularization in 14 cases of infected, immature teeth. Endodontic treatment was initiated, and after infection control, revascularization was performed. The access cavity was sealed with glass ionomer cement. The cases were followed up at regular intervals of 3 months; the range in follow-up was 0.5-3.5 years. The outcomes were as follows. Radiographic resolution of periradicular radiolucencies was judged to be good to excellent in 93% (13 of 14) of the cases. In the majority of cases, a narrowing of the wide apical opening was evident. In 3 cases, thickening of apical dentinal walls and increased root length were observed. The striking finding was complete resolution of clinical signs and symptoms and appreciable healing of periapical lesions in 78% (11 of 14) of cases. Thickening of lateral dentinal walls was evident in 57% (8/14) of cases, and increased root length was observed in 71% (10/14) of cases. None of the cases presented with pain, reinfection, or radiographic enlargement of preexisting apical pathology. This pilot study documented a favorable outcome of revascularization procedures conducted in immature nonvital, infected permanent teeth.

  9. A pilot evaluation of group-based programming offered at a Canadian outpatient adult eating disorders clinic.

    PubMed

    Mac Neil, Brad A; Leung, Pauline; Nadkarni, Pallavi; Stubbs, Laura; Singh, Manya

    2016-10-01

    Eating disorder clinics across Canada place heavy reliance on group-based programming. However, little work has examined whether this modality of treatment is well-received by patients and results in clinical improvements. The purpose of this pilot study was to evaluate patient satisfaction and outcomes for group-based programming offered through an adult eating disorders clinic. Participants were 81 adults who met DSM-5 criteria for an eating disorder and participated in the study as part of the clinic's program evaluation. Participants received medical monitoring, psychiatric follow-up, adjunct nutrition and pre-psychological treatment, and participated in the clinic's core cognitive behavioural therapy (CBT) group. Demographic information and weight were collected at intake. Participants also completed pre- and post-group programming measures of life satisfaction, depressive and anxiety symptoms, psychological symptoms of the eating disorder, and satisfaction with the programming. Participants' experienced a significant increase in satisfaction with life, and decreases in depressive symptoms and psychological symptoms of the eating disorder post-group. Adults endorsed feeling fairly satisfied with the group-based services provided. Results draw attention to the importance of program evaluation as an integral component of an adult outpatient eating disorder clinic by providing a voice for patients' views of the services received and program outcomes.

  10. A pilot study of BRCA mutation carriers' knowledge about the clinical impact of prophylactic-oophorectomy and views on fertility consultation: a single-center pilot study.

    PubMed

    Kim, J; Skrzynia, C; Mersereau, J E

    2015-02-01

    BRCA mutation carriers will experience early surgically induced menopause following prophylactic bilateral salpingo-oophorectomy (PBSO). This pilot study aimed to investigate their (1) knowledge about the clinical impact of PBSO; (2) views on fertility consultation (FC)/fertility preservation (FP) treatment; and (3) difficulties in conceiving compared to non-carriers. A cross-sectional, single institution web-survey was performed at a university-based IVF center. Women aged 18-50 years who were screened for BRCA gene mutations from 2005 to 2013 were recruited via mail. Forty-one BRCA-positive and 110 BRCA-negative women completed the survey (response rate: 50 %). The knowledge about the reproductive impact of PBSO was limited, with the majority of women in this highly educated sample only identifying the correct response 64 % of the time. Among BRCA mutation carriers, 24 (59 %) had positive views about FC/FP treatments. A larger proportion of women with no children at the time of BRCA testing, and those who were non-white tended to have positive views toward FP. Women with, versus without, BRCA mutations were more likely to have difficulty in conceiving (p = 0.08). This well-educated group had limited knowledge about the reproductive clinical impact of PBSO, or the benefit of a FP before PBSO. Most women with BRCA mutations were interested in FC/FP treatment if they had not completed childbearing at the time of screening. Targeted referrals for FC at the time of BRCA screening may help women improve knowledge and allow improved decision-making about reproductive options.

  11. (18)F Fluorocholine PET/MR Imaging in Patients with Primary Hyperparathyroidism and Inconclusive Conventional Imaging: A Prospective Pilot Study.

    PubMed

    Kluijfhout, Wouter P; Pasternak, Jesse D; Gosnell, Jessica E; Shen, Wen T; Duh, Quan-Yang; Vriens, Menno R; de Keizer, Bart; Hope, Thomas A; Glastonbury, Christine M; Pampaloni, Miguel H; Suh, Insoo

    2017-01-25

    Purpose To investigate the performance of flourine 18 ((18)F) fluorocholine (FCH) positron emission tomography (PET)/magnetic resonance (MR) imaging in patients with hyperparathyroidism and nonlocalized disease who have negative or inconclusive results at ultrasonography (US) and technetium 99m ((99m)Tc) sestamibi scintigraphy. Materials and Methods This study was approved by the institutional review board. Between May and December 2015, 10 patients (mean age, 70.4 years; range, 58-82 years) with biochemical primary hyperparathyroidism and inconclusive results at US and (99m)Tc sestamibi scintigraphy were prospectively enrolled. All patients gave informed consent. Directly after administration of 3 MBq/kg of FCH, PET imaging was performed, followed by T1- and T2-weighted MR imaging before and after gadolinium enhancement. Intraoperative localization and histologic results were the reference standard for calculating sensitivity and positive predictive value. The Wilcoxon rank test was used to calculate the mean difference in maximum standardized uptake value (SUVmax) between abnormal parathyroid uptake and physiologic thyroid uptake. The Wilcoxon rank-sum test was performed. Results MR imaging alone showed true-positive lesions in five patients and a false-positive lesion in one patient. FCH PET/MR imaging allowed correct localization of nine of 10 adenomas (90% sensitivity), without any false-positive results (100% positive predictive value). One patient had four-gland hyperplasia, of which three hyperplastic glands were not localized. The median SUVmax of the nine preoperatively identified adenomas was 4.9 (interquartile range, 2.45-7.35), which was significantly higher than the SUV, 2.7 (interquartile range, 1.6-3.8), of the thyroid (P = .008). Conclusion FCH PET/MR imaging allowed localization of adenomas with high accuracy when conventional imaging results were inconclusive and provided detailed anatomic information. More patients must be examined to confirm

  12. Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

    NASA Astrophysics Data System (ADS)

    Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

    2012-11-01

    Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic

  13. Treatment of Helicobacter pylori Infection with Intra-Gastric Violet Light Phototherapy – a Pilot Clinical Trial

    PubMed Central

    Lembo, Anthony J; Ganz, Robert A; Sheth, Sunil; Cave, David; Kelly, Ciaran; Levin, Philip; Kazlas, Peter T; Baldwin, Paul C; Lindmark, William R; McGrath, Jonathan R; Hamblin, Michael R

    2009-01-01

    Background and Objective Helicobacter pylori infects the mucus layer of the human stomach and causes peptic ulcers and adenocarcinoma. We have previously shown that H. pylori accumulates photoactive porphyrins making the organism susceptible to inactivation by light, and that small spot endoscopic illumination with violet light reduced bacterial load in human stomachs. This study assessed the feasibility and safety of whole-stomach intra-gastric violet phototherapy for the treatment of H. pylori infection. Study Design/Materials and Methods A controlled, prospective pilot trial was conducted using a novel light source consisting of laser diodes and diffusing fibers to deliver 408-nm illumination at escalating total fluences to the whole stomach. Eighteen adults (10 female) with H. pylori infection were treated at 3 U.S. academic endoscopy centers. Quantitative bacterial counts were obtained from biopsies taken from the antrum, body and fundus, and serial urea breath tests. Results The largest reduction in bacterial load was in the antrum (>97%), followed by body (>95%) and fundus (>86%). There was a correlation between log reduction and initial bacterial load in the antrum. There was no dose-response seen with increasing illumination times. The urea breath test results indicated that the bacteria repopulated in days following illumination. Conclusion Intragastric violet light phototherapy is feasible and safe and may represent a novel approach to eradication of H. pylori, particularly in patients who have failed standard antibiotic treatment. This was a pilot study involving a small number of patients. Further research is needed to determine if phototherapy can be effective for eradicating H. pylori. PMID:19533762

  14. 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

  15. The Effects of Ramelteon on Glucose Metabolism and Sleep Quality in Type 2 Diabetic Patients With Insomnia: A Pilot Prospective Randomized Controlled Trial

    PubMed Central

    Tsunoda, Tetsuji; Yamada, Masayo; Akiyama, Tomoaki; Minami, Taichi; Yoshii, Taishi; Kondo, Yoshinobu; Satoh, Shinobu; Terauchi, Yasuo

    2016-01-01

    Background Insomnia is associated with the onset and development of diabetes. Melatonin affects sleep quality and glucose metabolism in diabetic patients with insomnia. We administered ramelteon, an agonist of melatonin, to type 2 diabetic patients and investigated its effects on glucose metabolism and insomnia. Methods This multicenter, prospective, randomized, and observational pilot study was performed between April 2014 and April 2015 at three institutes in Japan. Patients were prescribed ramelteon 8 mg/day for 3 months (first period). And patients were divided at random into the continuation group that continued taking ramelteon and the discontinuation group that discontinued taking ramelteon for 3 additional months (second period). The primary endpoint was change in glycated hemoglobin (HbA1c) level. Secondary endpoints were changes in global Pittsburgh sleep questionnaire index (PSQI) score and other glucose metabolism makers. Results We enrolled 42 patients, and 32 patients completed the first period. Their mean HbA1c was 6.7%, and global PSQI score was 8.1 on average. HbA1c level did not change but global PSQI score improved from 8.1 to 7.2 by ramelteon (P = 0.030). Thirty-one patients completed the second period. HbA1c level did not change in the continuation group, but it increased from 6.7% to 6.9% (P = 0.003) in the discontinuation group. Global PSQI score did not change in each group. There was no rebound insomnia. Conclusion Treatment with ramelteon did not change the HbA1c level but improved sleep quality in type 2 diabetic patients with insomnia. Discontinuation of ramelteon slightly increased the HbA1c level and did not worsen sleep quality. PMID:27829954

  16. Mycophenolate Mofetil for Induction and Maintenance of Remission in Microscopic Polyangiitis with Mild to Moderate Renal Involvement—A Prospective, Open-Label Pilot Trial

    PubMed Central

    Silva, Francisco; Specks, Ulrich; Kalra, Sanjay; Hogan, Marie C.; Leung, Nelson; Sethi, Sanjeev

    2010-01-01

    Background and objectives: Microscopic polyangiitis (MPA) is a systemic small-vessel vasculitis associated with anti-neutrophil cytoplasmic antibodies (ANCA), often targeting myeloperoxidase (MPO). Cyclophosphamide (CYC) plus corticosteroids (CS) is considered standard therapy for patients with renal involvement, but treatment response is not satisfactory in all patients and CYC has well recognized toxicity. This prospective pilot trial explored whether mycophenolate mofetil (MMF) represents an effective alternative to CYC for induction and maintenance of remission in MPA with mild to moderate renal involvement. Design, setting, participants, & measurements: Seventeen P-ANCA/MPO-ANCA-positive patients with MPA with mild to moderate renal involvement received MMF (1000 mg orally, twice daily) and CS (intravenous methylprednisolone, 1 to 3 g, followed by oral prednisone at 1 mg/kg per day). Oral CS were discontinued by month 6; MMF was continued through month 18. The primary outcome measure was remission by month 6 and stable renal function. Secondary endpoints included major relapses necessitating a switch to CYC plus CS, minor relapses requiring an increase in CS dosage, and adverse events. Results: Thirteen of 17 patients enrolled achieved the primary outcome, and 4 failed because of insufficient response, relapse, or MMF intolerance. Twelve patients remained in remission through month 18, renal function remained stable, and proteinuria improved. Side effects of MMF were mild, transient, and responsive to dose adjustments in all patients except one. Conclusions: MMF represents an alternative to CYC for induction and maintenance of remission in patients with MPO-ANCA-associated MPA with mild to moderate renal disease. PMID:20093349

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

    PubMed

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

    2013-04-01

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

  18. PROSPECTIVE COMPARISON OF TUMOR STAGING USING COMPUTED TOMOGRAPHY VERSUS MAGNETIC RESONANCE IMAGING FINDINGS IN DOGS WITH NASAL NEOPLASIA: A PILOT STUDY.

    PubMed

    Lux, Cassie N; Culp, William T N; Johnson, Lynelle R; Kent, Michael; Mayhew, Philipp; Daniaux, Lise A; Carr, Alaina; Puchalski, Sarah

    2017-02-24

    Identification of nasal neoplasia extension and tumor staging in dogs is most commonly performed using computed tomography (CT), however magnetic resonance imaging (MRI) is routinely used in human medicine. A prospective pilot study enrolling six dogs with nasal neoplasia was performed with CT and MRI studies acquired under the same anesthetic episode. Interobserver comparison and comparison between the two imaging modalities with regard to bidimensional measurements of the nasal tumors, tumor staging using historical schemes, and assignment of an ordinal scale of tumor margin clarity at the tumor-soft tissue interface were performed. The hypotheses included that MRI would have greater tumor measurements, result in higher tumor staging, and more clearly define the tumor soft tissue interface when compared to CT. Evaluation of bone involvement of the nasal cavity and head showed a high level of agreement between CT and MRI. Estimation of tumor volume using bidimensional measurements was higher on MRI imaging in 5/6 dogs, and resulted in a median tumor volume which was 18.4% higher than CT imaging. Disagreement between CT and MRI was noted with meningeal enhancement, in which two dogs were positive for meningeal enhancement on MRI and negative on CT. One of six dogs had a higher tumor stage on MRI compared to CT, while the remaining five agreed. Magnetic resonance imaging resulted in larger bidimensional measurements and tumor volume estimates, along with a higher likelihood of identifying meningeal enhancement when compared to CT imaging. Magnetic resonance imaging may provide integral information for tumor staging, prognosis, and treatment planning.

  19. The use of school teachers to promote oral hygiene in some secondary school students at Hyderabad, Andhra Pradesh, India: A short term prospective pilot study

    PubMed Central

    Chandrashekar, Byalakere R.; Suma, Shankarappa; Kiran, Kaverikana; Manjunath, Badhravathi C.

    2012-01-01

    Study design: It was a short term prospective pilot study on a group of 116 secondary school students. Objectives: To assess the feasibility of using the services of school teachers to promote oral hygiene in secondary school students and compare the effectiveness of dental health education (DHE) offered by school teachers on a fortnightly basis with what is offered by dental professionals at three- monthly intervals. Materials and Methods: Six secondary schools were randomly selected. The base-line Oral Hygiene Index simplified (OHI-S) and Plaque index (PI) scores for all the students were recorded. The teachers were trained on dental health facts. The six schools were divided into three groups of two schools with different intervention techniques: Group 1- Schools given no health education, Group 2 – Schools given health education by their school teachers on a fortnightly basis together with simple screening for deposits of gross calculus , Group 3 – Schools which were given health education by dental professionals at intervals of three months without any screening. Grade nine students were selected for pre and post intervention evaluation. The second examination was done six months following the intervention to find out the OHI-S and Plaque index scores. The examination was done by three trained and calibrated dentists. Data analysis was done with SPSS 16 with relevant statistical tests. Results: The mean OHI-S and PI scores were significantly less in group 2 and there was a statistically significant difference between the baseline OHI – S, PI score and the scores after six months in all the three groups. Conclusion: The concept of utilizing the teachers for frequent DHE and screening for any gross deposits of food debris and calculus is feasible. Also frequent DHE by teachers was more effective than the infrequent DHE by the professionals. PMID:23230385

  20. Optimal Combination of Effective ANtihypertensives (OCEAN) study: a prospective, randomized, open-label, blinded endpoint trial--rationale, design and results of a pilot study in Japan.

    PubMed

    Kageyama, Shigeru; Ueda, Shinichiro; Mochizuki, Kouichi; Miyakawa, Masaaki; Sugawara, Masahiro; Nakayama, Michio; Ohashi, Yasuo; Saito, Ikuo; Saruta, Takao

    2012-02-01

    There are limited clinical trials examining the efficacy of antihypertensive drug combinations aimed at preventing cardiovascular events. Therefore, we designed a randomized controlled trial using amlodipine as the base drug of a multi-drug regimen, the Optimal Combination of Effective ANtihypertensives (OCEAN) Study, to determine the drug combination that is most efficacious in the prevention of cardiovascular events, such as stroke. The OCEAN Study is a collaborative study between Japan and China, enrolling 20 000 patients and following them for 3 to 4 years. A pilot study was conducted before the full-scale study to confirm the feasibility of the protocol and that the study groups and infrastructures could function properly. A total of 279 Japanese patients were enrolled from 57 participating medical institutions between June and December 2004. Two hundred and sixty-six patients (mean age: 65.9 years) were treated with amlodipine alone. One hundred and fifty-four of these patients (57.9%) did not reach the treatment targets (<140/90 mm Hg for the elderly and patients with cerebrovascular disease, <130/80 mm Hg for those with diabetes mellitus, chronic kidney disease or prior myocardial infarction) and a second agent was added. They were randomly allocated into three different treatment groups using a diuretic, a β-blocker or an angiotensin-converting enzyme inhibitor/angiotensin II receptor antagonist. The pilot study showed that the protocol was appropriate, and the inclusion of patients with slightly higher blood pressures was necessary to increase the randomization rate. It also confirmed that we organized properly functioning study groups and infrastructures.

  1. 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

  2. Head-and-Neck Target Delineation Among Radiation Oncology Residents After a Teaching Intervention: A Prospective, Blinded Pilot Study

    SciTech Connect

    Bekelman, Justin E. Wolden, Suzanne; Lee, Nancy

    2009-02-01

    Purpose: We conducted this study to determine the feasibility of incorporating a teaching intervention on target delineation into the educational curriculum of a radiation oncology residency program and to assess the short-term effects on resident skills. Methods and Materials: The study schema consisted of a baseline evaluation, the teaching intervention, and a follow-up evaluation. At the baseline evaluation, the participants contoured three clinical tumor volumes (CTVs) (70 Gy, 59.4 Gy, and 54 Gy) on six contrast-enhanced axial computed tomography images of a de-identified patient with Stage T2N2bM0 squamous cell carcinoma of the right base of the tongue. The participants attended a series of head-and-neck oncology and anatomy seminars. The teaching intervention consisted of a didactic lecture and an interactive hands-on practical session designed to improve the knowledge and skills for target delineation in the head and neck. At the follow-up evaluation, the residents again contoured the CTVs. Results: Of the 14 eligible residents, 11 (79%) actually participated in the study. For all participants, but especially for those who had not had previous experience with head-and-neck target delineation, the teaching intervention was associated with improvement in the delineation of the node-negative neck (CTV 54 Gy contour). Regardless of clinical experience, participants had difficulty determining what should be included in the CTV 59.4 Gy contour to ensure adequate coverage of potential microscopic disease. Conclusion: Incorporating a teaching intervention into the education curriculum of a radiation oncology residency program is feasible and was associated with short-term improvements in target delineation skills. Subsequent interventions will require content refinement, additional validation, longer term follow-up, and multi-institutional collaboration.

  3. Clinical Practice Improvement Approach in Multiple Sclerosis Rehabilitation: A Pilot Study

    ERIC Educational Resources Information Center

    Khan, Fary

    2010-01-01

    The objective of this study was to explore methods examining patient complexity and therapy interventions in relation to functional outcomes from an inpatient multiple sclerosis (MS) rehabilitation program. Retrospective and prospective data for 24 consecutive inpatients at a tertiary rehabilitation facility assessed (i)…

  4. Metaphor use and health literacy: a pilot study of strategies to explain randomization in cancer clinical trials.

    PubMed

    Krieger, Janice L; Parrott, Roxanne L; Nussbaum, Jon F

    2011-01-01

    Patients often have difficulty understanding what randomization is and why it is needed in Phase III clinical trials. Physicians commonly report using metaphorical language to convey the role of chance in being assignment to treatment; however, the effectiveness of this strategy as an educational tool has not been explored. Guided by W. McGuire's (1972) information-processing model, the purpose of this pilot study was to explore effects of metaphors to explain randomization on message acceptance and behavioral intention to participate in a Phase III clinical trial among a sample of low-income, rural women (N = 64). Participants were randomly assigned to watch a video that explained randomization using 1 of 3 message strategies: a low-literacy definition, standard metaphor (i.e., flip of a coin), or a culturally derived metaphor (i.e., sex of a baby). The influence of attention on behavioral intentions to participate in clinical trials was partially moderated by message strategy. Under conditions of low attention, participants in the culturally derived metaphor condition experienced significantly higher intentions to participate in clinical trials compared with participants in the standard metaphor condition. However, as attention increased, differences in intentions among the conditions diminished. Having a positive affective response to the randomization message was a strong, positive predictor of behavioral intentions to participate in clinical trials. The authors discuss the theoretical and practical implications of these findings.

  5. Comparability of ophthalmic diagnoses by clinical and Reading Center examiners in the Visual Acuity Impairment Survey Pilot Study.

    PubMed

    Sperduto, R D; Hiller, R; Podgor, M J; Palmberg, P; Ferris, F L; Wentworth, D

    1986-12-01

    Technologic advances in ophthalmic equipment offer the possibility of replacing direct clinical examinations with Reading Center evaluations of data recorded in epidemiologic studies. Clinical and Reading Center examiners made independent ophthalmic diagnoses of 133 right and 132 left eyes of 138 adults in the Visual Acuity Impairment Survey Pilot Study, carried out in three US cities, Boston, Detroit, and Minneapolis, in August 1981-December 1982. The Reading Center diagnosed eye conditions using only photographic and visual field data collected at the time of the clinical examination. In the comparisons of clinical and Reading Center evaluations reported here, only eyes judged by the examiners to have pathology severe enough to reduce visual acuity to 6/9 or worse were classified as having pathology. (No visual acuity criterion was required for the diagnosis of glaucoma or diabetic retinopathy.) There was agreement in diagnostic assessments between clinical and Reading Center examiners in about 80% of eyes. The kappa statistic, which adjusts for chance agreement, was in the fair to good range: 0.60 for 133 right eyes and 0.62 for 132 left eyes. When the Reading Center examiners were provided with additional information on medical history, refractive error and best corrected visual acuity, the agreement between clinical and Reading Center assessments among the subset of eyes with 6/9 or worse vision again was in the fair to good range, with kappas of 0.61 for 45 right eyes and 0.68 for 48 left eyes. Inter-observer agreement between Reading Center examiners in diagnosing pathology was in the good to excellent range. Use of Reading Centers in future epidemiologic studies should be considered, but elimination of the clinical examinations is not recommended until modifications in the protocol described here have been made and shown to improve levels of agreement between clinical and Reading Center examiners.

  6. Comparison of a minimally invasive procedure versus standard microscopic discotomy: a prospective randomised controlled clinical trial

    PubMed Central

    Greiner-Perth, R.; Boehm, H.; Mahlfeld, K.; Grasshoff, H.; Allam, Y.; Awiszus, F.

    2009-01-01

    A Prospective randomised controlled study was done to determine statistical difference between the standard microsurgical discotomy (MC) and a minimally invasive microscopic procedure for disc prolapse surgery by comparing operation duration and clinical outcome. Additionally, the transferability of the results was determined by a bicentric design. The microscopic assisted percutaneous nucleotomy (MAPN) has been advocated as a minimally invasive tubular technique. Proponents have claimed that minimally invasive procedures reduce postoperative pain and accelerate the recovery. In addition, there exist only a limited number of well-designed comparison studies comparing standard microdiscotomy to a tubular minimally invasive technique that support this claim. Furthermore, there are no well-designed studies looking at the transferability of those results and possible learning curve phenomena. We studied 100 patients, who were planned for disc prolapse surgery at two centres [50 patients at the developing centre (index) and 50 patients at the less experienced (transfer) centre]. The randomisation was done separately for each centre, employing a block-randomisation procedure with respect to age and preoperative Oswestry score. Operation duration was chosen as a primary outcome parameter as there was a distinguished shortening observed in a preliminary study at the index centre enabling a sound case number estimation. The following data were compared between the two groups and the centres with a 12-month follow-up: surgical times (operation duration and approach duration), the clinical results, leg and back pain by visual analogue scale, the Oswestry disability index, length of hospital stay, return to work time, and complications. The operation duration was statistically identical for MC (57.8 ± 20.2 min) at the index centre and for MAPN (50.3 ± 18.3 min) and MC (54.7 ± 18.1 min) at the transfer centre. The operation duration was only significantly shorter

  7. [Resorbable rods and screws for fixation of ankle fractures. A randomized clinical prospective study].

    PubMed

    Springer, M A; van Binsbergen, E A; Patka, P; Bakker, F C; Haarman, H J

    1998-05-01

    A prospective randomized clinical trial was performed to evaluate the use of self-reinforced absorbable composites (Biofix) in the fixation of ankle fractures. The aim of this study was to demonstrate that fixation with Biofix rods and screws is as good as the standard A.O. fixation. The benefits of Biofix rods and screws are: a reduction in costs since no secondary operation is needed, prevention of stress-shielding and thereby diminishing the risk of bone porosity. Patients aged between 16 and 75 years old with closed, non-comminuted fractures of the lateral and/or medial malleolus and dislocation of the fracture fragments greater than 2 mm were included in the study. 22 patients were treated with Biofix rods and screws and the control group of 19 patients with a standard technique. After 3, 6 and 12 months, rontgenograms were taken. At the same time functional results were evaluated following the criteria of Olerud and Molander. Two patients were withdrawn from the trial for non-medical reasons. 22 patients (12 from the Biofix group, 10 from the AO group) operated two or more years ago were contacted to see if any complications had occurred since they were last seen. In 4 cases a Biofix screw broke down just beneath the head during insertion. This did not result in an insufficient fixation of the fracture. There were no early post-operative complications. The functional and rontgenological results in both groups were equal. In three cases a sterile sinus developed at the site of screw insertion. Biofix rods and screws, made of polylactic acid, are a good alternative for the fixation of fractures of the ankle. The use of resorbable fracture fixation material has the advantage that a second operation to remove osteosynthesis material is not necessary. The long term results are good. There is, however, a possibility of development of tissue reaction to the resorbable material.

  8. 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

  9. Prospective evaluation of clinical scoring systems in infants with bronchiolitis admitted to the intensive care unit.

    PubMed

    Rödl, S; Resch, B; Hofer, N; Marschitz, I; Madler, G; Eber, E; Zobel, G

    2012-10-01

    The objective of this investigation was to compare different scoring systems to assess the severity of illness in infants with bronchiolitis admitted to a tertiary paediatric intensive care unit (PICU). Over an 18-year period (1990-2007), infants with bronchiolitis aged up to 12 months and admitted to the PICU were prospectively scored using the Pediatric Risk of Mortality III (PRISM III) score, the Organ System Failure (OSF) score and the Acute Physiologic Score for Children (APSC) within 24 h. Infants were compared as to whether or not bronchiolitis was associated with respiratory syncytial virus (RSV). There was no difference between 113 RSV-positive and 80 RSV-negative infants regarding gestational age, birth weight, rate of premature delivery or bronchopulmonary dysplasia (BPD). The PRISM III score differed significantly between RSV-positive and RSV-negative cases (3.27 ± 0.39 vs. 1.96 ± 0.44, p = 0.006), as did the OSF score (0.56 ± 0.05 vs. 0.35 ± 0.06, p = 0.049) and the APSC (5.16 ± 0.46 vs. 4.1 ± 0.53, p = 0.048). All scores were significantly higher in the subgroup with mechanical ventilation (p < 0.0001). The mean time of ventilation was significantly higher in the RSV-positive group compared to the RSV-negative group (6.39 ± 1.74 days vs. 2.4 ± 0.47 days, p < 0.001). Infants suffering from RSV-positive bronchiolitis had higher clinical scores corresponding with the severity of bronchiolitis.

  10. Computer assisted electromagnetic navigation improves accuracy in computed tomography guided interventions: A prospective randomized clinical trial

    PubMed Central

    2017-01-01

    Purpose To assess the accuracy and usability of an electromagnetic navigation system designed to assist Computed Tomography (CT) guided interventions. Materials and methods 120 patients requiring a percutaneous CT intervention (drainage, biopsy, tumor ablation, infiltration, sympathicolysis) were included in this prospective randomized trial. Nineteen radiologists participated. Conventional procedures (CT group) were compared with procedures assisted by a navigation system prototype using an electromagnetic localizer to track the position and orientation of a needle holder (NAV group). The navigation system displays the needle path in real-time on 2D reconstructed CT images extracted from the 3D CT volume. The regional ethics committee approved this study and all patients gave written informed consent. The main outcome was the distance between the planned trajectory and the achieved needle trajectory calculated from the initial needle placement. Results 120 patients were analyzable in intention-to-treat (NAV: 60; CT: 60). Accuracy improved when the navigation system was used: distance error (in millimeters: median[P25%; P75%]) with NAV = 4.1[2.7; 9.1], vs. with CT = 8.9[4.9; 15.1] (p<0.001). After the initial needle placement and first control CT, fewer subsequent CT acquisitions were necessary to reach the target using the navigation system: NAV = 2[2; 3]; CT = 3[2; 4] (p = 0.01). Conclusion The tested system was usable in a standard clinical setting and provided significant improvement in accuracy; furthermore, with the help of navigation, targets could be reached with fewer CT control acquisitions. PMID:28296957

  11. 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

  12. 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

  13. Multi-Institutional Registry for Prostate Cancer Radiosurgery: A Prospective Observational Clinical Trial

    PubMed Central

    Freeman, Debra; Dickerson, Gregg; Perman, Mark

    2015-01-01

    Objective: To report on the design, methodology, and early outcome results of a multi-institutional registry study of prostate cancer radiosurgery. Methods: The Registry for Prostate Cancer Radiosurgery (RPCR) was established in 2010 to further evaluate the efficacy and toxicity of prostate radiosurgery (SBRT) for the treatment of clinically localized prostate cancer. Men with prostate cancer were asked to voluntarily participate in the registry. Demographic, baseline medical, and treatment-related data were collected and stored electronically in a Health Insurance Portability and Accountability Act-compliant database, maintained by Advertek, Inc. Enrolled men were asked to complete short, multiple choice questionnaires regarding their bowel, bladder, and sexual function. Patient-reported outcome forms were collected at baseline and at regular intervals (every 3–6 months) following treatment. Serial prostate-specific antigen measurements were obtained at each visit and included in the collected data. Results: From July 2010 to July 2013, nearly 2000 men from 45 participating sites were enrolled in the registry. The majority (86%) received radiosurgery as monotherapy. At 2 years follow-up, biochemical disease-free survival was 92%. No Grade 3 late urinary toxicity was reported. One patient developed Grade 3 gastrointestinal toxicity (rectal bleeding). Erectile function was preserved in 80% of men <70 years old. Overall compliance with data entry was 64%. Conclusion: Stereotactic radiosurgery is an alternative option to conventional radiotherapy for the treatment of organ-confined prostate cancer. The RPCR represents the collective experience of multiple institutions, including community-based cancer centers, with outcome results in keeping with published, prospective trials of prostate SBRT. PMID:25657929

  14. [Mason vertical gastroplasty in treatment of morbid obesity. Results of a prospective clinical study].

    PubMed

    Naef, M; Sadowski, C; de Marco, D; Sabbioni, M; Balsiger, B; Laederach, K; Bürgi, U; Büchler, M W

    2000-04-01

    Morbid obesity (body mass index > 40 kg/m2) is a risk factor for cardiovascular, pulmonary, metabolic, neoplastic, and psychologic sequelae. In the present prospective clinical study 65 patients (11 men, 54 women) underwent vertical banded gastroplasty (Mason procedure) from June 1994 to October 1997. The median age was 41 +/- 5.3 years (range 18-69; n = 65). Preoperative body weight was 135 +/- 23 kg (96-229; n = 65), excess body weight in kg was 75 +/- 6.9 (44-155; n = 65) or in % 126 +/- 10 (78-223; n = 65) and BMI was 49 +/- 7.4 kg/m2 (39-69; n = 65). Mean hospital stay was 9.7 +/- 2.4 days (6-18; n = 65). Hospital mortality was 0% (0/65). Early complications were vomiting (30%) and problems in wound healing (15%; n = 65). Late complications (> 30 days) were incisional hernias (13.8%) and staple-line disruptions (12.3%; n = 65) with a reoperation rate of 23% (15/65). Median follow-up was 15.0 +/- 5.2 months (2-42) with a follow up rate of 100%. Mean weight loss after 12 months was 38.5 +/- 17 kg (30-98; n = 34) (P < 0.0001) and loss of excessive body weight 65 +/- 10% (57-86; n = 34), respectively (P < 0.0001). Cardiovascular risk factors (hypertension, diabetes, hyperlipidemia) were significantly improved within 12 months (n = 34). Vertical banded gastroplasty (Mason procedure)--well established for 20 years--is a good, safe therapy for morbid obesity if strict indications for operation are observed and if there is multidisciplinary long-term follow-up. Comorbid risk factors are considerably reduced and a long-term weight loss of more than 50% can be achieved without the risk of pathological metabolic changes.

  15. 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.

  16. 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).

  17. Antibiotics in periodontal surgeries: A prospective randomised cross over clinical trial

    PubMed Central

    Oswal, Sheetal; Ravindra, Shivamurthy; Sinha, Aditya; Manjunath, Shaurya

    2014-01-01

    Aims and Objectives: (1) To evaluate the need of antibiotics in periodontal surgeries in reducing postsurgical infections and explore if antibiotics have any key role in reducing or eliminating inflammatory complications. (2) To establish the incidence of postoperative infections in relation to type of surgery and determine those factors, which may affect infection rates. Materials and Methods: A prospective randomized double-blind cross over clinical study was carried out for a period of 1-year with predefined inclusion and exclusion criteria. All the patients included in the study for any periodontal surgery were randomly divided into three categories: Group A (prophylactic), Group B (therapeutic), and Group C (no antibiotics). Patients were followed up for 1-week after surgery on the day of suture removal and were evaluated for pain, swelling, fever, infection, delayed wound healing and any other significant findings. Appropriate statistical analysis was carried out to evaluate the objectives and P < 0.05 was considered as statistically significant. Results: No infection was reported in any of 90 sites. Patients reported less pain and postoperative discomfort when prophylactic antibiotics were given. However, there were no statistical significant differences between the three groups. Summary and Conclusion: There was no postoperative infection reported in all the 90 sites operated in this study. The prevalence of postoperative infections following periodontal surgery is <1% and this low risk does not justify the routine use of systemic antimicrobials just to prevent infections. Use of prophylactic antibiotics may have role in prevention of inflammatory complication, but again not infection. PMID:25425817

  18. 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.

  19. Autonomization of free flaps in the oral cavity: A prospective clinical study.

    PubMed

    Mücke, Thomas; Wolff, Klaus-D; Rau, Andrea; Kehl, Victoria; Mitchell, David A; Steiner, Timm

    2012-03-01

    Controversy exists over how long a free flap is dependent on its pedicle and if neovascularization is different between flap types, recipient sites, and irradiated and nonirradiated patients. An understanding of the timing of this process should optimize the safety of secondary procedures involving the flap. In a prospective clinical study, hemoglobin oxygenation and capillary flow were measured in 50 flaps (25 forearm flaps, 15 osteocutaneous fibula flaps, and 10 anterolateral thigh flaps) 4 and 12 weeks postoperatively. The flaps were located at the floor of the mouth, cheek, or tongue (n = 39) or at the hard or soft palate (n = 11). Measurements were carried out using the O2C monitoring system under temporary digital occlusion of the pedicle. After 4 weeks, 17 free flaps were found to be autonomized indicated by the O2C measurements comparing both values before and after digital compression of the vascular pedicle. After 12 weeks, 41 patients had completion of free flap autonomization, as indicated by the HbO(2) and CF before and after pedicle compression. The location of free flap in the lower jaw (P < 0.0001 after 4 weeks, P = 0.013 after 12 weeks), fasciocutaneous radial forearm flaps after 4 weeks (P < 0.0001), and not irradiated recipient site after 4 weeks (P = 0.014) were found to be positive factors significantly influencing autonomization. In conclusion, free flap autonomization depends on several variables which should be considered before further surgery after free flap reconstruction as the transferred tissue can be still dependent on its pedicle.

  20. 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

  1. Paramedic and midwifery student exposure to workplace violence during clinical placements in Australia – A pilot study

    PubMed Central

    McKenna, Lisa

    2016-01-01

    Objectives The objective of this pilot study was to identify the type of workplace violence experienced by undergraduate paramedic and midwifery students. Methods The study used a cross-sectional methodology with the self-administered paper-based Paramedic Workplace Violence Exposure Questionnaire to elicit undergraduate paramedic and midwife responses to workplace violence whilst on clinical placements. There were 393 students eligible for inclusion in the study. A convenience sample was used. The anonymous questionnaire took 10 to 20 minutes to complete. Descriptive statistics are used to summarise the data with a two-tailed t-test used to compare groups. Results The main form of workplace violence was verbal abuse 18% and intimidation 17%. There was a statistically significant difference between midwifery and paramedic students for intimidation (t(134)=-3.143, CI: -0.367 to -0.082, p=0.002) and between females and males for sexual harassment (t(134)=2.029, CI: 0.001 to 0.074, p=0.045), all other results were not statistically different. Conclusions This pilot study is the first of its kind in Australia and internationally to identify exposure rates of workplace violence by undergraduate paramedic students during clinical placements and one of very few to identify midwifery students’ exposure rates of workplace violence. The study identified that students were exposed to a range of workplace violence acts from verbal abuse through to sexual harassment. These findings highlight a need for investigation of workplace violence exposure of medical, nursing and allied health students during the clinical phase of their studies. PMID:27941182

  2. Pre-Operative Status and Quality of Life Following Total Joint Replacement in a Developing Country: A Prospective Pilot Study

    PubMed Central

    Niu, Nina N.; Collins, Jamie E.; Thornhill, Thomas S.; Alcantara Abreu, Luis; Ghazinouri, Roya; Okike, Kanu; Katz, Jeffrey N.

    2011-01-01

    Background: An increasing number of medical relief organizations have launched programs to perform total joint replacements in the developing world. There is a paucity of data on the clinical outcomes of these procedures. We documented pre- and post-operative pain and functional status in a group of low income Dominicans who underwent total hip or knee replacement performed by an American relief organization. Methods: In March 2009 and 2010, we surveyed patients participating in Operation Walk Boston, a medical relief organization that provides total joint replacements to patients in the Dominican Republic. Questionnaires included the Western Ontario and McMaster University Osteoarthritis (WOMAC) Index scales and the Short-Form 36 (SF-36) scales for physical activity and mental health. Scores were transformed to a 0 - 100 point scale (100 is best). Results: 81 individuals (mean age 61 years, 60% female) completed the pre-operative questionnaires. Twenty eight of the 35 who completed preoperative forms in 2009 also completed follow up forms in 2010 (follow-up rate 80%). Patients reported poor pre-operative WOMAC function (mean = 33.6, sd = 22.0) and WOMAC pain (mean = 38.4, sd = 22.9) scores preoperatively. Mean post-operative WOMAC pain and function scores were 86.4 (sd = 13.1) and 88.1 (sd = 11.4) respectively. Improvement in pain and function was similar for patients undergoing hip (n=11) and knee (n=17) replacements. Conclusion: Total joint replacement was effective in relieving pain and restoring function in this program. These results are useful for comparison to outcomes in developed countries and for establishing benchmarks for future programs. PMID:21886686

  3. Clinical and hemodynamic profiles of elderly patients with pulmonary arterial hypertension: a single center, prospective study

    PubMed Central

    Ozpelit, Ebru; Akdeniz, Bahri; Sezgin, Dilek; Sevinc, Can; Tertemiz, Kemal Can; Ozpelit, Mehmet Emre; Baris, Mustafa; Baris, Nezihi

    2017-01-01

    Backgrounds Pulmonary arterial hypertension (PAH) was previously considered an illness that affects mostly the young, but now it is also increasingly recognized in the elderly. The aim of this study was to compare the features of elderly versus younger patients diagnosed with PAH, and to define the prognostic factors which affect their long-term survival. Methods In this prospective, single center study, the clinical, echocardiographic, hemodynamic characteristics, and the outcomes of younger (18–65 years) and elderly (≥ 65 years) patients with definitive diagnosis of precapillary PAH were compared. Results A total of 119 patients were analyzed in this study; 43 were elderly (mean age: 71.5 ± 5.5 years), while 76 were non-elderly (mean age 44.5 ± 15.2 years). During the mean follow-up duration of 26.8 ± 25.0 months, 43 deaths occurred, 17 of which were among the elderly group, with 28 among non-elderly group. Comparison of baseline parameters showed that 6 min walking distance, hemoglobin levels, pulmonary artery pressures and pulmonary vascular resistance were significantly lower; and estimated glomerular filtration rate, body mass index, E/e' and pulmonary capillary wedge pressure were significantly higher in the elderly group than in the younger group. Survival analysis demonstrated that the independent predictors of death were tricuspid plane annular systolic excursion (TAPSE; HR: 1.272, 95% CI: 1.079–1.499, P = 0.004) and uric acid (HR: 1.291, 95% CI: 1.042–1.600, P = 0.019) in the elderly group. In contrast, in the non-elderly group, higher brain natriuretic peptide (HR: 1.002, 95% CI: 1.001–1.004, P < 0.001) and higher right atrial pressure (HR: 1.128, 95% CI: 1.026–1.241, P = 0.013) values were the only parameters associated with mortality. Conclusions Our data suggest that elderly PAH patients have a unique clinical and hemodynamic profile, with totally different prognostic markers compared to younger PAH patients. PMID:28270838

  4. Impaired neck motor function and pronounced pain-related fear in helicopter pilots with neck pain - a clinical approach.

    PubMed

    Ang, Björn Olov

    2008-08-01

    There is recognition that neck pain is a significant clinical problem in military aviation. In the present trial, the objectives were to explore neck motor function and pain-related fear in pilots with differing progression of neck pain. Seventy-two military helicopter pilots were enrolled: 20 had acute ongoing neck pain, 27 had subacute pain, and 25 were pain-free controls. Neck-flexor electromyography activity (root-mean-square) during staged active craniocervical flexion, median power frequency during sustained neck-flexor contraction, cervical range of motion, rating of perceived exertion after sustained flexor contraction, and rated fear-avoidance beliefs about physical activity were estimated. Main effects emerged for flexor activity, fear-avoidance and range of motion, but not for median frequency variables or perceived exertion. Post hoc testing showed that, compared to controls, both pain groups had greater flexor activity at higher stages of craniocervical flexion while the acute group had higher fear-avoidance and less range of motion in axial rotation and flexion-extension, all P<0.01. Discriminant regression revealed a sensitivity/specificity of 87%/71% (neck-pain/controls), with the flexor activity superior. The results indicate that altered neuromotor synergies are present at different progressions of pain. The tracing of such aberrant activity and fear-avoidance beliefs is suggested in future screening and neck intervention research.

  5. Neovascularisation and pain in jumper's knee: a prospective clinical and sonographic study in elite junior volleyball players

    PubMed Central

    Gisslen, K; Alfredson, H; Peers, K

    2005-01-01

    Background: The nature of tendon neovascularisation associated with pain over time has not been studied. Objective: To prospectively study the patellar tendons in elite junior volleyball players. Methods: The patellar tendons in all students at the Swedish National Centre for high school volleyball were evaluated clinically and by ultrasonography (US) and Power Doppler (PD) sonography. Results: Altogether 120 patellar tendons were followed for 7 months. At inclusion, jumper's knee was diagnosed clinically in 17 patellar tendons. There were structural changes on US in 14 tendons, in 13 of which PD sonography showed neovascularisation. There were 70 clinically normal tendons with normal US and PD sonography, 24 clinically normal tendons with abnormal US but normal PD sonography, and nine clinically normal tendons with abnormal US and neovascularisation on PD sonography. At 7 month follow up, jumper's knee was diagnosed clinically and by US in 19 patellar tendons, in 17 of which there was neovascularisation. Three of nine clinically normal tendons with structural changes and neovascularisation at inclusion developed jumper's knee. Two of 24 tendons clinically normal at inclusion, with abnormal US but normal PD sonography, developed jumper's knee with abnormal US and neovascularisation on PD sonography. A total of 20 clinically normal tendons with normal US and PD sonography at inclusion developed structural tendon changes and 12 of these also developed neovascularisation. Conclusions: The clinical diagnosis of jumper's knee is most often associated with neovascularisation in the area with structural tendon changes. The finding of neovessels might indicate a deterioration of the condition. PMID:15976162

  6. Naltrexone effect on pulsatile GnRH therapy for ovulation induction in polycystic ovary syndrome: a pilot prospective study.

    PubMed

    Fulghesu, A M; Ciampelli, M; Belosi, C; Apa, R; Guido, M; Caruso, A; Mancuso, S; Lanzone, A

    2001-01-01

    a decrease of insulin secretion. Further randomized studies should be performed in order to obtain significant conclusions on the possible clinical application.

  7. A Short-Term, Prospective Test of the Interpersonal-Psychological Theory of Suicidal Ideation in an Adolescent Clinical Sample.

    PubMed

    Miller, Adam Bryant; Esposito-Smythers, Christianne; Leichtweis, Richard N

    2016-06-01

    The present prospective study tested a portion of the interpersonal-psychological theory of suicide (IPTS) in an adolescent clinical sample. Participants were 143 adolescents consecutively admitted to a partial hospitalization program who completed assessments at intake and discharge from the program. Results partially supported the IPTS and suggest that (1) perceived burdensomeness may be an important socially based cognition for understanding concurrent risk for suicidal ideation (SI); (2) thwarted belongingness affects depression symptom severity over time, which indirectly predicts SI over a short follow-up time frame; and (3) the IPTS constructs may function differently in a high-risk clinical adolescent sample, compared to adults, although findings are preliminary.

  8. Behavioral couples therapy for smoking cessation: A pilot randomized clinical trial.

    PubMed

    LaChance, Heather; Cioe, Patricia A; Tooley, Erin; Colby, Suzanne M; O'Farrell, Timothy J; Kahler, Christopher W

    2015-09-01

    Behavioral couples therapy (BCT) has been found to improve long-term abstinence rates in alcohol- and substance-dependent populations but has not been tested for smoking cessation. This pilot study examined the feasibility and acceptability of BCT for smoking-discordant couples. Forty-nine smokers (smoking >10 cigarettes/day) with nonsmoking partners were randomized to receive a couples social support (BCT-S) intervention or an individually delivered, standard smoking cessation treatment (ST). The couples were married or had been cohabiting for at least 1 year, with partners who had never smoked or had not used tobacco in 1 year. Both treatments included 7 weekly sessions and 8 weeks of nicotine replacement therapy. Participants were followed for 6 months posttreatment. The Partner Interaction Questionnaire was used to measure perceived smoking-specific partner support. Participants were 67% male and 88% White. Biochemically verified cessation rates were 40.9%, 50%, and 45% in BCT-S and 59.1%, 50%, and 55% in ST at end of treatment, after 3 month, and after 6 months, respectively, and did not differ significantly between treatment conditions at any time point. Perceived smoking-specific partner support at posttreatment did not significantly differ between treatment groups. Results of this pilot study do not provide support for the efficacy of BCT in smoking-discordant couples.

  9. 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

  10. Development of training-related health care software by a team of clinical educators: their experience, from conception to piloting.

    PubMed

    Ap Dafydd, Derfel; Williamson, Ruth; Blunt, Philip; Blunt, Dominic M

    2016-01-01

    The difficulties of producing useful, bespoke, and affordable information technology systems for large health care organizations are well publicized, following several high-profile endeavors in the UK. This article describes the experience of a small group of clinical radiologists and their collaborators in producing an information technology system - from conception to piloting. This system, called Trainee Tracker, enables automated target date recalculation of trainee milestones, depending on their work patterns and other individual circumstances. It utilizes an automated email alert system to notify the educational supervisors and trainees of approaching and elapsed target dates, in order to identify trainees in difficulty early and address their training needs accordingly. The challenges and advantages, both common to and contrasting with larger-scale projects, are also considered. The benefits of the development team's "agile" approach to software development and the lessons learned will be of interest to medical educators, particularly those with expertise in e-portfolios and other training-related software.

  11. Preclinical and Pilot Clinical Studies of Docetaxel Chemoradiation for Stage III Non-Small-Cell Lung Cancer

    SciTech Connect

    Chen Yuhchyau; Pandya, Kishan J.; Hyrien, Ollivier; Keng, Peter C.; Smudzin, Therese; Anderson, Joy; Qazi, Raman; Smith, Brian; Watson, Thomas J.; Feins, Richard H.; Johnstone, David W.

    2011-08-01

    Purpose: Local and distant failure rates remain high despite aggressive chemoradiation (CRT) treatment for Stage III non-small-cell lung cancer. We conducted preclinical studies of docetaxel's cytotoxic and radiosensitizing effects on lung cancer cell lines and designed a pilot study to target distant micrometastasis upfront with one-cycle induction chemotherapy, followed by low-dose radiosensitizing docetaxel CRT. Methods and Materials: A preclinical study was conducted in human lung cancer cell lines NCI 520 and A549. Cells were treated with two concentrations of docetaxel for 3 h and then irradiated immediately or after a 24-h delay. A clonogenic survival assay was conducted and analyzed for cytotoxic effects vs. radiosensitizing effects of docetaxel. A pilot clinical study was designed based on preclinical study findings. Twenty-two patients were enrolled with a median follow-up of 4 years. Induction chemotherapy consisted of 75 mg/m{sup 2} of docetaxel and 75 mg/m{sup 2} of cisplatin on Day 1 and 150 mg/m{sup 2} of recombinant human granulocyte colony-stimulating factor on Days 2 through 10. Concurrent CRT was started 3 to 6 weeks later with twice-weekly docetaxel at 10 to 12 mg/m{sup 2} and daily delayed radiation in 1.8-Gy fractions to 64.5 Gy for gross disease. Results: The preclinical study showed potent cytotoxic effects of docetaxel and subadditive radiosensitizing effects. Delaying radiation resulted in more cancer cell death. The pilot clinical study resulted in a median survival of 32.6 months for the entire cohort, with 3- and 5-year survival rates of 50% and 19%, respectively, and a distant metastasis-free survival rate of 61% for both 3 and 5 years. A pattern-of-failure analysis showed 75% chest failures and 36% all-distant failures. Therapy was well tolerated with Grade 3 esophagitis observed in 23% of patients. Conclusions: One-cycle full-dose docetaxel/cisplatin induction chemotherapy with recombinant human granulocyte colony-stimulating factor

  12. Psychiatric Residents' Attitudes toward and Experiences with the Clinical-Skills Verification Process: A Pilot Study on U.S. and International Medical Graduates

    ERIC Educational Resources Information Center

    Rao, Nyapati R.; Kodali, Rahul; Mian, Ayesha; Ramtekkar, Ujjwal; Kamarajan, Chella; Jibson, Michael D.

    2012-01-01

    Objective: The authors report on a pilot study of the experiences and perceptions of foreign international medical graduate (F-IMG), United States international medical graduate (US-IMG), and United States medical graduate (USMG) psychiatric residents with the newly mandated Clinical Skills Verification (CSV) process. The goal was to identify and…

  13. Enhancing Risk Detection Among Homeless Youth: A Randomized Clinical Trial of a Promising Pilot Intervention.

    PubMed

    Bender, Kimberly A; DePrince, Anne; Begun, Stephanie; Hathaway, Jessica; Haffejee, Badiah; Schau, Nicholas

    2016-03-02

    Homeless youth frequently experience victimization, and youth with histories of trauma often fail to detect danger risks, making them vulnerable to subsequent victimization. The current study describes a pilot test of a skills-based intervention designed to improve risk detection among homeless youth through focusing attention to internal, interpersonal, and environmental cues. Youth aged 18 to 21 years (N = 74) were recruited from a shelter and randomly assigned to receive usual case management services or usual services plus a 3-day manualized risk detection intervention. Pretest and posttest interviews assessed youths' risk detection abilities through vignettes describing risky situations and asking youth to identify risk cues present. Separate 2 (intervention vs. control) × 2 (pretest vs. posttest) mixed ANOVAs found significant interaction effects, as intervention youth significantly improved in overall risk detection compared with control youth. Post hoc subgroup analyses found the intervention had a greater effect for youth without previous experiences of indirect victimization than those with previous indirect victimization experiences.

  14. Behavioral Couples Therapy for Smoking Cessation: A pilot randomized clinical trial

    PubMed Central

    LaChance, Heather; Cioe, Patricia A.; Tooley, Erin; Colby, Suzanne M.; O’Farrell, Timothy J.; Kahler, Christopher W.

    2016-01-01

    Introduction Behavioral couples therapy (BCT) has been found to improve long-term abstinence rates in alcohol- and substance-dependent populations but has not been tested for smoking cessation. This pilot study examined the feasibility and acceptability of BCT for smoking-discordant couples. Methods Forty-nine smokers (smoking >10 cigarettes/day) with non-smoking partners were randomized to receive a couples social support (BCT-S) intervention, or an individually-delivered smoking cessation (ST) treatment. The couples were married or cohabiting for at least one year, with partners who had never smoked or had not used tobacco in one year. Both treatments included seven weekly sessions and 8-weeks of nicotine replacement therapy. Participants were followed for six months post-treatment. The Partner Interaction Questionnaire (PIQ) was used to measure perceived smoking-specific partner support. Results Participants were 67% male and 88% White. Biochemically-verified cessation rates were 40.9%, 50% and 45% in BCT-S, and 59.1%, 50%, and 55% in ST, at end of treatment, 3-, and 6-months, respectively, and did not differ significantly between treatment conditions at any time point (all p’s > .05). Perceived smoking-specific partner support at post-treatment did not significantly differ between treatment groups (M=2.45, SD .81 in BCT-S; M=2.27, SD .92 in ST; t(38) = .67, p = .51). Conclusions Results of this pilot study do not provide support for the efficacy of BCT in smoking discordant couples. PMID:25642582

  15. Evaluation of factors predicting clinical pleural injury during percutaneous nephrolithotomy: a prospective study.

    PubMed

    Sharma, Kuldeep; Sankhwar, Satya Narayan; Singh, Vishwajeet; Singh, Bhupendra Pal; Dalela, Diwakar; Sinha, Rahul Janak; Kumar, Manoj; Singh, Manmeet; Goel, Apul

    2016-06-01

    The purpose of this study is to prospectively identify factors that predict the chance of pleural injury (detected clinically or on postoperative X-ray chest) during percutaneous nephrolithotomy (PCNL). All patients with renal/upper ureteric stones, undergoing PCNL between January 2013 and June 2014, were evaluated for pleural injury. An erect chest X-ray on inspiration was done within 6 h of PCNL. The patients were divided into Groups A and B depending on whether they developed or did not develop pleural injury. Patient-, stone-, renal-, and procedure-related factors were compared between the two groups. 332 patients with mean age 36.76 ± 15.01 years (range 4-80) and M:F of 172:160 fulfilled the inclusion criteria. Pleural complications occurred in 10 patients (3 %). Of 141 patients with supracostal punctures (59 had additional infracostal punctures), 4.2 % (n = 6) had pleural injury. Of 191 patients with only infracostal punctures, 4 developed pleural injuries (2 %). Patients in group A had significantly lower age (27.00 ± 11.18 vs. 37.06 ± 15.03, p = 0.03) and lower BMI (18.0 ± 1.90 vs. 21.12 ± 2.24 p = 0.002). Incidence of pleural injury was significantly higher (p = 0.001) on right side [4.0 % (7/172) vs. 1.8 %, 3/160)]. Incidence of pleural injury had no association with staghorn calculi, stone surface area (590.51 ± 313.88 for Group A vs. 593.02 ± 387.10 for Group B; p = 0.11), degree of hydronephrosis, and operative time (65.13 ± 19.45 for Group A vs. 72.21 ± 19.56 for Group B; p = 0.06). On multivariate analysis, only low BMI and mean age <27 years were associated with higher risk of pleural injury. Higher incidence of pleural injury was noted in patients with low BMI and younger age.

  16. Work-related upper-extremity disorders: prospective evaluation of clinical and functional outcomes.

    PubMed

    Pransky, G; Benjamin, K; Himmelstein, J; Mundt, K; Morgan, W; Feuerstein, M; Koyamatsu, K; Hill-Fotouhi, C

    1999-10-01

    The purpose of this study was to describe the demographic, vocational, medical, workplace, and psychosocial characteristics of patients treated for work-related upper-extremity disorders, to document treatment patterns in a community-practice setting, and to determine which of these factors predicts subsequent employment and functional status outcomes. A questionnaire was administered by mail or telephone to 112 patients seen at the University of Massachusetts Occupational Upper Extremities Disorders Clinic and included measures of disease-specific functional status, pain, reactions to pain, employer-employee relations, and number and type of interventions used to treat the disorder. Results were compared with baseline data obtained, on average, 16 months prior to follow-up. Of the original cohort (n = 124), 112 participated in the prospective study. Although most patients reported improvement in pain severity, fear of pain, life situation, and functional status, there was little change in employment status. Patients' self-reported intentions of return to work at baseline did not predict work status at follow-up. In general, those who were employed at baseline remained employed, had a greater reduction in symptom severity over time, and were significantly more likely to report improvement in their problem than those who were unemployed. The efficacy of various interventions was examined by type, mix, and intensity (number of different interventions undergone by the patient). No positive relationship was found between these measures and employment status, self-reported change in the problem, or self-reported improvement in functional status. Significant negative relationships were found between surgery, psychotherapeutic interventions, and outcomes. This was likely to have occurred because of a selection bias toward the more chronic and severely disabled patients for these treatments. However, the relative ineffectiveness of such intensive interventions as surgery

  17. 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

  18. 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

  19. Assessing DSM-5 level of personality functioning from videotaped clinical interviews: a pilot study with untrained and clinically inexperienced students.

    PubMed

    Zimmermann, Johannes; Benecke, Cord; Bender, Donna S; Skodol, Andrew E; Schauenburg, Henning; Cierpka, Manfred; Leising, Daniel

    2014-01-01

    Several authors have raised the concern that the DSM-5 Level of Personality Functioning Scale (LPFS) is relatively complex and theory laden, and thus might put high requirements on raters. We addressed this concern by having 22 untrained and clinically inexperienced students assess the personality functioning of 10 female psychotherapy inpatients from videotaped clinical interviews, using a multi-item version of the LPFS. Individual raters' LPFS total scores showed acceptable interrater reliability, and were significantly associated with 2 distinct expert-rated measures of the severity of personality pathology. These findings suggest that, contrary to the previously mentioned concerns, successfully applying the LPFS to clinical cases might require neither extensive clinical experience nor training.

  20. A Pilot Survey of Patient-Initiated Assaults on Medical Students during Clinical Clerkship

    ERIC Educational Resources Information Center

    Waddell, Andrea E.; Katz, Mark R.; Lofchy, Jodi; Bradley, John

    2005-01-01

    Objectives: To assess the incidents of patient-initiated assault (PIA) against clinical clerks during the first six months of clinical clerkship. To characterise the assaults with respect to service, location, clerk gender, patient gender. To examine the students' perceptions of the reporting process for PIA. Methods: A brief email survey was sent…

  1. Clinical Realization of Sector Beam Intensity Modulation for Gamma Knife Radiosurgery: A Pilot Treatment Planning Study

    SciTech Connect

    Ma, Lijun; Mason, Erica; Sneed, Penny K.; McDermott, Michael; Polishchuk, Alexei; Larson, David A.; Sahgal, Arjun

    2015-03-01

    Purpose: To demonstrate the clinical feasibility and potential benefits of sector beam intensity modulation (SBIM) specific to Gamma Knife stereotactic radiosurgery (GKSRS). Methods and Materials: SBIM is based on modulating the confocal beam intensities from individual sectors surrounding an isocenter in a nearly 2π geometry. This is in contrast to conventional GKSRS delivery, in which the beam intensities from each sector are restricted to be either 0% or 100% and must be identical for any given isocenter. We developed a SBIM solution based on available clinical planning tools, and we tested it on a cohort of 12 clinical cases as a proof of concept study. The SBIM treatment plans were compared with the original clinically delivered treatment plans to determine dosimetric differences. The goal was to investigate whether SBIM would improve the dose conformity for these treatment plans without prohibitively lengthening the treatment time. Results: A SBIM technique was developed. On average, SBIM improved the Paddick conformity index (PCI) versus the clinically delivered plans (clinical plan PCI = 0.68 ± 0.11 vs SBIM plan PCI = 0.74 ± 0.10, P=.002; 2-tailed paired t test). The SBIM plans also resulted in nearly identical target volume coverage (mean, 97 ± 2%), total beam-on times (clinical plan 58.4 ± 38.9 minutes vs SBIM 63.5 ± 44.7 minutes, P=.057), and gradient indices (clinical plan 3.03 ± 0.27 vs SBIM 3.06 ± 0.29, P=.44) versus the original clinical plans. Conclusion: The SBIM method is clinically feasible with potential dosimetric gains when compared with conventional GKSRS.

  2. Blinded and unblinded internal pilot study designs for clinical trials with count data.

    PubMed

    Schneider, Simon; Schmidli, Heinz; Friede, Tim

    2013-07-01

    Internal pilot studies are a popular design feature to address uncertainties in the sample size calculations caused by vague information on nuisance parameters. Despite their popularity, only very recently blinded sample size reestimation procedures for trials with count data were proposed and their properties systematically investigated. Although blinded procedures are favored by regulatory authorities, practical application is somewhat limited by fears that blinded procedures are prone to bias if the treatment effect was misspecified in the planning. Here, we compare unblinded and blinded procedures with respect to bias, error rates, and sample size distribution. We find that both procedures maintain the desired power and that the unblinded procedure is slightly liberal whereas the actual significance level of the blinded procedure is close to the nominal level. Furthermore, we show that in situations where uncertainty about the assumed treatment effect exists, the blinded estimator of the control event rate is biased in contrast to the unblinded estimator, which results in differences in mean sample sizes in favor of the unblinded procedure. However, these differences are rather small compared to the deviations of the mean sample sizes from the sample size required to detect the true, but unknown effect. We demonstrate that the variation of the sample size resulting from the blinded procedure is in many practically relevant situations considerably smaller than the one of the unblinded procedures. The methods are extended to overdispersed counts using a quasi-likelihood approach and are illustrated by trials in relapsing multiple sclerosis.

  3. [Prospective evaluation of clinical parameters of AAT patients with i. v. prolastin therapy in a homecare setting].

    PubMed

    Wilke, A; Grohé, C

    2013-10-01

    Prognostic parameters and indicators of deterioration of prolastin substituted alpha 1 antitrypsin deficient COPD (AAT) are poorly defined. In particular, there is a lack of information how patients with AAT report exacerbations or how intravenous therapy with prolastin is tolerated and leads to a stabilization of the clinical course of the disease. In a prospective study seven patients were followed over 36 months who received i. v. prolastin at home. Both clinical parameters such as exacerbations and spirometric lung function tests were used to monitor the clinical course of the disease. During the time period given 2.1 exacerbations/year were documented, the average lung function loss over the period of 36 month was mean FEV1 1.02 ± 0.61 l/s to 0.94 ± 0.63 l/s and mean vital capacity 2.95 ± 0.82 l to 2.87 ± 0.81 l. Complications related to home based infusion therapy did not occur. No non elective hospitalisations were reported. Taken together, this prospective feasibility trial could show that home based i. v. therapy in patients with AAT is safe and leads to less exacerbations and loss of lung function as compared to the historical cohort.

  4. Integrated genomic and prospective clinical studies show the importance of modular pleiotropy for disease susceptibility, diagnosis and treatment

    PubMed Central

    2014-01-01

    Background Translational research typically aims to identify and functionally validate individual, disease-specific genes. However, reaching this aim is complicated by the involvement of thousands of genes in common diseases, and that many of those genes are pleiotropic, that is, shared by several diseases. Methods We integrated genomic meta-analyses with prospective clinical studies to systematically investigate the pathogenic, diagnostic and therapeutic roles of pleiotropic genes. In a novel approach, we first used pathway analysis of all published genome-wide association studies (GWAS) to find a cell type common to many diseases. Results The analysis showed over-representation of the T helper cell differentiation pathway, which is expressed in T cells. This led us to focus on expression profiling of CD4+ T cells from highly diverse inflammatory and malignant diseases. We found that pleiotropic genes were highly interconnected and formed a pleiotropic module, which was enriched for inflammatory, metabolic and proliferative pathways. The general relevance of this module was supported by highly significant enrichment of genetic variants identified by all GWAS and cancer studies, as well as known diagnostic and therapeutic targets. Prospective clinical studies of multiple sclerosis and allergy showed the importance of both pleiotropic and disease specific modules for clinical stratification. Conclusions In summary, this translational genomics study identified a pleiotropic module, which has key pathogenic, diagnostic and therapeutic roles. PMID:24571673

  5. Evaluation of the efficacy of an hyaluronic acid-based biogel on periodontal clinical parameters. A randomized-controlled clinical pilot study

    PubMed Central

    Pilloni, Andrea; Annibali, Susanna; Dominici, Francesco; Di Paolo, Carlo; Papa, Marco; Cassini, Maria Antonietta; Polimeni, Antonella

    2012-01-01

    Summary Hyaluronic acid (HA) is an ubiquitous form of non-sulphated glycosaminoglycan of the extracellular matrix of all mammalian connective tissues. It is mainly present during tissue’s formation or during most of initial tissue’s repair processess. Cell migration, adhesion and differentiation are only part of several unique biological characteristics of HA which have been under investigation in the past decades. Aim of the study Evaluate the possible positive effect of an esterified form of HA on gingival tissues in mild chronic periodontitis patients, seeking for the reduction of all the periodontal disease clinical parameters PLI (Plaque Index), BOP (Bleeding on Probing), PPD (Probing Pocket Depth), GI (Gingival Index), PAL (Probing Attachment Level). Materials and methods The study is an open, intra-patient, controlled, single center pilot clinical trial including 19 adult patients with mild chronic periodontitis and shallow pockets (< 4 mm) in at least two different quadrants. One quadrant was treated with HA gel after regular toothbrushing (test), the other without (control). Results Although oral hygiene itself had a similar positive influence on the improvement of all the clinical indexes for test and control, the treatment with HA gel showed a greater effect almost always statistically significant. BOP in the HA gel treated areas had a decrease of 92.7% and GI of 96.5%, whereas controls 75.8% and 79.0% respectively. The difference of PPD in both areas was statistically significant (p<0.01) in favour of the HA gel treated zone. Also PAL and Pl were reduced more with gel than with oral hygiene alone, although this did not reach a statistical significant difference. Conclusion It appears that an esterified gel form of HA has shown an effect in reducing the gingival inflammation when used as an adjunct to mechanical home plaque control and that it could be successfully used to improve the periodontal clinical indexes. This pilot study will gain

  6. The aneurysmal arteriovenous fistula - morphological study and assessment of clinical implications. A pilot study.

    PubMed

    Watson, Kenneth R; Gallagher, Maeve; Ross, Rose; Severn, Alison; Nagy, Janos; Cochrane, Lynda; Griffiths, Gareth D

    2015-10-01

    Aneurysmal dilation of arteriovenous fistulae used for haemodialysis is a recognised complication but its clinical significance is a contentious issue. Our aims were to describe aneurysmal fistulae morphologically and clinically.Sixty patients underwent duplex scanning to measure the maximum diameter and skin thickness of their fistula. Haemodialysis function and bleeding risk were assessed clinically.The 75th percentile of maximum diameter was 2.05 cm. In addition to conventional diameter measurement, we describe a novel volume measurement technique which may be of value. No relationship was found between maximum diameter or volume and function, skin thickness or bleeding.Some studies define aneurysm at 2 cm (75th percentile); however, this definition and other arbitrary definitions lack clinical significance. This work suggests that fistula dilation should be considered together with clinical issues when determining the clinical significance of an aneurysm. Our finding that haemodialysis function, skin thickness and bleeding were not associated with diameter needs further study.

  7. A clinic-based youth development program to reduce sexual risk behaviors among adolescent girls: prime time pilot study.

    PubMed

    Sieving, Renee E; Bernat, Debra H; Resnick, Michael D; Oliphant, Jennifer; Pettingell, Sandra; Plowman, Shari; Skay, Carol

    2012-07-01

    Multifaceted, sustained efforts are needed to reduce early pregnancy and sexually transmitted diseases among high-risk adolescents. An important area for research is testing youth development interventions offered through clinic settings, where access to high-risk adolescents is plentiful and few efforts have rigorously evaluated a dual approach of building protective factors while addressing risk. This article presents findings from a pilot study of Prime Time, a clinic-based youth development intervention to reduce sexual risk behaviors among girls at risk for early pregnancy. Girls aged 13 to 17 years meeting specified risk criteria were assigned to Prime Time treatment groups. The Prime Time intervention included a combination of case management services and peer leadership groups. Participants completed self-report surveys at baseline, 12 and 18 months following enrollment. At 12 months, the intervention group reported significantly fewer sexual partners than the control group. At 18 months, the intervention group reported significantly more consistent condom use with trends toward more consistent hormonal and dual method use. Dose-response analyses suggested that relatively high levels of exposure to a youth development intervention were needed to change contraceptive use behaviors among adolescents at risk for early pregnancy. Given promising findings, further testing of the Prime Time intervention is warranted.

  8. A pilot study on conducting mobile learning activities for clinical nursing courses based on the repertory grid approach.

    PubMed

    Wu, Po-Han; Hwang, Gwo-Jen; Tsai, Chin-Chung; Chen, Ya-Chun; Huang, Yueh-Min

    2011-11-01

    In clinical nursing courses, students are trained to identify the status of the target patients. The mastery of such ability and skills is very important since patients frequently need to be cared for immediately. In this pilot study, a repertory grid-oriented clinical mobile learning system is developed for a nursing training program. With the assistance of the mobile learning system, the nursing school students are able to learn in an authentic learning scenario, in which they can physically face the target patients, with the personal guidance and supplementary materials from the learning system to support them. To show the effectiveness of this innovative approach, an experiment has been conducted on the "respiratory system" unit of a nursing course. The experimental results show that the innovative approach is helpful to students in improving their learning achievements. Moreover, from the questionnaire surveys, it was found that most students showed favorable attitudes toward the usage of the mobile learning system and their participation in the training program.

  9. Influence of data display formats on physician investigators’ decisions to stop clinical trials: prospective trial with repeated measures

    PubMed Central

    Elting, Linda S; Martin, Charles G; Cantor, Scott B; Rubenstein, Edward B

    1999-01-01

    Objective To examine the effect of the method of data display on physician investigators’ decisions to stop hypothetical clinical trials for an unplanned statistical analysis. Design Prospective, mixed model design with variables between subjects and within subjects (repeated measures). Setting Comprehensive cancer centre. Participants 34 physicians, stratified by academic rank, who were conducting clinical trials. Interventions Participants were shown tables, pie charts, bar graphs, and icon displays containing hypothetical data from a clinical trial and were asked to decide whether to continue the trial or stop for an unplanned statistical analysis. Main outcome measure Percentage of accurate decisions with each type of display. Results Accuracy of decisions was affected by the type of data display and positive or negative framing of the data. More correct decisions were made with icon displays than with tables, pie charts, and bar graphs (82% v 68%, 56%, and 43%, respectively; P=0.03) and when data were negatively framed rather than positively framed in tables (93% v 47%; P=0.004). Conclusions Clinical investigators’ decisions can be affected by factors unrelated to the actual data. In the design of clinical trials information systems, careful consideration should be given to the method by which data are framed and displayed in order to reduce the impact of these extraneous factors. Key messagesIn clinical trials formal interim monitoring points, at which statistical tests are conducted, are designated a priori, but investigators also conduct informal interim monitoring, when statistical tests are not usedThis study investigated the effect of the method of displaying results on clinical investigators’ decisions to conduct unplanned analyses of a hypothetical clinical trialThe method of displaying results significantly influenced the accuracy of decisions, as did the framing of these results (positive or negative)The display formats preferred by the

  10. Protracted Hypofractionated Radiotherapy for Graves' Ophthalmopathy: A Pilot Study of Clinical and Radiologic Response

    SciTech Connect

    Casimiro de Deus Cardoso, Cejana; Giordani, Adelmo Jose; Borri Wolosker, Angela Maria; Souhami, Luis; Gois Manso, Paulo; Souza Dias, Rodrigo; Comodo Segreto, Helena Regina; Araujo Segreto, Roberto

    2012-03-01

    Purpose: To evaluate the clinical and radiologic response of patients with Graves' ophthalmopathy given low-dose orbital radiotherapy (RT) with a protracted fractionation. Methods and Materials: Eighteen patients (36 orbits) received orbital RT with a total dose of 10 Gy, fractionated in 1 Gy once a week over 10 weeks. Of these, 9 patients received steroid therapy as well. Patients were evaluated clinically and radiologically at 6 months after treatment. Clinical response assessment was carried out using three criteria: by physical examination, by a modified clinical activity score, and by a verbal questionnaire considering the 10 most common signs and symptoms of the disease. Radiologic response was assessed by magnetic resonance imaging. Results: Improvement in ocular pain, palpebral edema, visual acuity, and ocular motility was observed in all patients. Significant decrease in symptoms such as tearing (p < 0.001) diplopia (p = 0.008), conjunctival hyperemia (p = 0.002), and ocular grittiness (p = 0.031) also occurred. Magnetic resonance imaging showed decrease in ocular muscle thickness and in the intensity of the T2 sequence signal in the majority of patients. Treatments were well tolerated, and to date no complications from treatment have been observed. There was no statistical difference in clinical and radiologic response between patients receiving RT alone and those receiving RT plus steroid therapy. Conclusion: RT delivered in at a low dose and in a protracted scheme should be considered as a useful therapeutic option for patients with Graves' ophthalmopathy.

  11. Vitamin D-mediated calcium absorption in patients with clinically stable Crohn's disease: a pilot study.

    PubMed

    Kumari, Meena; Khazai, Natasha B; Ziegler, Thomas R; Nanes, Mark S; Abrams, Steven A; Tangpricha, Vin

    2010-08-01

    Vitamin D is the critical hormone for intestinal absorption of calcium. Optimal calcium absorption is important for proper mineralization of bone in the prevention of osteoporosis and osteoporotic fractures, among other important functions. Diseases associated with gut inflammation, such as Crohn's disease (CD), may impair calcium absorption. This pilot study evaluated vitamin D- dependent calcium absorption in subjects with CD. Male subjects with CD (n=4) and healthy age-matched controls (n=5) were studied. All subjects had fractional calcium absorption (FCA; by the dual calcium isotope method), serum 25-hydroxyvitamin D, serum calcium and 24 h urinary calcium excretion measurements at baseline. The FCA in response to vitamin D therapy was re-assessed following administration of oral calcitriol 0.25 mcg twice daily for 1 wk, followed by oral calcitriol 0.50 mcg twice daily for 1 wk. Serum calcium and 24 h urinary calcium determinations were re-assessed after each increasing dose of calcitriol as safety measures. There was no significant difference in calcium FCA at baseline or after increasing doses of calcitriol between the CD and controls. FCA in the control and CD group was approximately 35% at baseline, which increased to 60% after calcitriol therapy. No subject developed hypercalcemia or hypercalciuria. Our results suggest that CD patients have a normal response to vitamin D in enhancing the efficacy of calcium absorption. This suggests that stable CD patients can follow calcium and vitamin D guidelines of non-CD adults. Other factors independent of vitamin D status may impair intestinal calcium absorption in CD, including the degree and location of inflammation, presence of surgical resection and/or use of glucocorticoids.

  12. Patient-centeredness and empathy in a bilingual interprofessional primary care teaching clinic: a pilot study

    PubMed Central

    Mayer, Sallie D; Peterfy, Erika; Crossman, Steven H; Phipps, Lisa Burroughs; Vanderbilt, Allison A

    2016-01-01

    Utilizing the Consultation and Relational Empathy survey, this project examined the perceptions of care team empathy and patient-centeredness between English- and Spanish-speaking patients. From fall through spring semesters, patient surveys from a primary care, interprofessional student-led teaching clinic were collected and analyzed. Overall, mean scores for both English- and Spanish-speaking patients were above the reported normative average for general practitioners. While, overall, patients expressed satisfaction with the student-led teaching clinic in terms of empathy and patient-centeredness, English-speaking patients had higher median scores than Spanish-speaking patients. Analyzed individually, questions related to communication and provider attitudes were scored lower by Spanish-speaking patients. These results demonstrate that student-led clinics can deliver patient-centered care and highlight the continuing need to investigate and address disparities between English- and Spanish-speaking patients with regard to feelings of empathy and patient-centeredness. PMID:27601915

  13. Patient-centeredness and empathy in a bilingual interprofessional primary care teaching clinic: a pilot study.

    PubMed

    Mayer, Sallie D; Peterfy, Erika; Crossman, Steven H; Phipps, Lisa Burroughs; Vanderbilt, Allison A

    2016-01-01

    Utilizing the Consultation and Relational Empathy survey, this project examined the perceptions of care team empathy and patient-centeredness between English- and Spanish-speaking patients. From fall through spring semesters, patient surveys from a primary care, interprofessional student-led teaching clinic were collected and analyzed. Overall, mean scores for both English- and Spanish-speaking patients were above the reported normative average for general practitioners. While, overall, patients expressed satisfaction with the student-led teaching clinic in terms of empathy and patient-centeredness, English-speaking patients had higher median scores than Spanish-speaking patients. Analyzed individually, questions related to communication and provider attitudes were scored lower by Spanish-speaking patients. These results demonstrate that student-led clinics can deliver patient-centered care and highlight the continuing need to investigate and address disparities between English- and Spanish-speaking patients with regard to feelings of empathy and patient-centeredness.

  14. A prospective pilot study to evaluate wound outcomes and levels of serum C-reactive protein and interleukin-6 in the wound fluid of patients with trauma-related chronic wounds.

    PubMed

    Liu, Tao; Yang, Fan; Li, Zhanfei; Yi, Chengla; Bai, Xiangjun

    2014-06-01

    If surgical closure of chronic wounds is an option, choosing an appropriate time to definitely close these wounds remains a challenge. Although the underlying mechanisms of nonhealing are not completely understood, serum C-reactive protein (CRP) and interleukin-6 (IL-6) in wound fluid have been found to be markers of the systemic and local inflammation state of chronic wounds. The purpose of this prospective, descriptive pilot study was to evaluate the effect of debridement, systemic antibiotics, and negative pressure wound therapy (NPWT) on the outcomes of trauma-related chronic wounds and changes in local inflammation responses, measured using CRP and IL-6 levels as indicators of cytokine regulation. Between June 2012 and May 2013, 20 consecutive patients (14 men, six women, mean age 40 [range 17-56] years) with various trauma-related, nonhealing chronic wounds were enrolled in the study after failing to heal for an average of 8.5 (range 6-16) weeks using a protocol of regular debridement and gauze dressings. Before the start of the study, wounds were cultured, and laboratory values for white blood cell count (WBC), neutrophils, and levels of serum CRP and IL-6 in the wound fluid obtained. Wounds were surgically debrided and NPWT (continuous at 125 mm Hg) applied. All patients were prescribed systemic antibiotics, and mean time interval between NPWT dressing changes was 5 (range 3-7) days. During an average mean NPWT treatment time of 13 (range 5-20) days, CRP and IL-6 concentrations decreased from 66.4 mg/L to 10.4 mg/L and 44.1 pg/mL to 8.6 pg/mL, respectively (P <0.001). The presence/absence of bacteria, WBC, and neutrophil counts did not change. No complications were noted, and all wounds were successfully closed using various surgical procedures. In this study, clinical wound improvement and a significant decrease in wound fluid CRP and IL-6 levels were observed. Studies with a larger sample size and a more robust study design may help elucidate the

  15. Motives for participating in a clinical research trial: a pilot study in Brazil

    PubMed Central

    2013-01-01

    Background In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil. Methods Mixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing. Results The motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study. Conclusions The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral

  16. How Stable are Temperaments in the Clinical Setting: A Pilot Study

    PubMed Central

    Karam, Elie G.; El Khoury, Elaine; Itani, Lynn

    2016-01-01

    Background An essential point in evaluating the utility of measuring temperaments is the stability of the instrument used especially in the presence of mental disorders. One of the most commonly used instruments in the clinical setting is the Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire (TEMPS-A). To our knowledge, the TEMPS-A’s stability in an outpatient adult clinical setting has not been evaluated. Objective: To assess the stability of the effect of temperament, time and clinical intervention. Methods: A sample of 89 adult outpatients was assessed at baseline and follow-up on their TEMPS-A scores. Diagnoses of mental disorders were reached through clinical interviews, and the severity of the conditions was clinically assessed at baseline and follow-up on a Likert scale. Changes in scores were examined in terms of z-scores, and possible predictors of the change in scores were assessed. Results: Eighty-nine percent of all subjects’ temperaments scores did not change or changed less than one z-score, and specifically: 84.2% in the case of depressive, 89.9% for cyclothymic, 92.1% for hyperthymic, 92.2% for irritable, and 86.5% for anxious temperaments. For all of the five temperaments, age, gender, time difference between baseline and follow up, number of diagnoses, and percent improvement were not significantly associated with the change in temperament scores. Limitations: Well-established severity measures would add to the validity of any future findings. Conclusion: Shifts in temperament scores between baseline and follow-up were minor, thus proving the stability of temperaments and the TEMPS-A scale in a clinical setting. PMID:27733865

  17. The Relationship between Athletic Training Student Critical Thinking Skills and Clinical Instructor Supervision: A Pilot Study

    ERIC Educational Resources Information Center

    Kabay, Michele R.

    2013-01-01

    The purpose of this study was to 1) assess the critical thinking skill level of the athletic training student at onset and end of the clinical education experience 2) to examine the influence of the students' critical thinking skills and the CIs' supervision responses to the changes in the students' critical thinking skills and 3) to compare the…

  18. Help-Seeking Behaviors among Athletic Training Students in the Clinical Education Setting: A Pilot Study

    ERIC Educational Resources Information Center

    Nakajima, Mikiko Aoyagi; Freesemann, Keith W.

    2013-01-01

    Context: Help-seeking is an important self-regulating and proactive strategy that prepares students to be successful learners. It is particularly important in the clinical education setting, in which students must actively engage in learning. Objective: To determine both the type of help-seeking behaviors used by athletic training students in the…

  19. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    ERIC Educational Resources Information Center

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  20. Peer Mentorship in Clinical Education: Outcomes of a Pilot Programme for First Year Students.

    ERIC Educational Resources Information Center

    Yates, Patsy; Cunningham, Jackie; Moyle, Wendy; Wollin, Judy

    1997-01-01

    Responses from 21 nursing students and 7 peer mentors indicated that most participated to practice clinical skills; mentees received considerable help in reducing anxiety and increasing self-confidence; timing and organization of mentoring sessions were a problem; and mentors also made personal gains. (SK)

  1. Virtual patients for assessment of clinical reasoning in nursing -- a pilot study.

    PubMed

    Forsberg, Elenita; Georg, Carina; Ziegert, Kristina; Fors, Uno

    2011-11-01

    In different nursing programmes, one important learning outcome is clinical reasoning (CR) skills. However, to date, there is limited number of methods available for assessment of CR skills; especially for distance-based courses. This study investigates students' opinions about the feasibility of using Virtual Patients (VPs) for assessing CR in nursing education. VPs were introduced as an assessment tool in three different nursing courses at two universities, comprising 77 students in total. Students' overall acceptance of this assessment tool, including its applicability to the practise of nursing and the potential of VP-based assessment as a learning experience, were investigated using questionnaires. Course directors used the Web-SP system to assess students' interactions with VPs and their answers regarding diagnoses, caring procedures and their justifications. Students' found the VP cases to be realistic and engaging, and indicate a high level of acceptance for this assessment method. In addition, the students' indicated that VPs were good for practising their clinical skills, although some would prefer that the VP system be less "medical" and asked for more focus on nursing. Although most students supplied correct diagnoses and made adequate clinical decisions, there was a wide range in their ability to explain their clinical reasoning processes.

  2. Women's preferences for the location of abortion services: a pilot study in two Chicago clinics.

    PubMed

    Logsdon, Melissa B; Handler, Arden; Godfrey, Emily M

    2012-01-01

    Between July and December 2006, 209 women at a university-based primary care center and a freestanding abortion clinic completed a verbally administered questionnaire in which they were asked their preference for the location of early abortion services. Sixty women seeking primary care services at the university-based clinic and 149 women seeking first-trimester abortion services at an abortion clinic completed the questionnaire. Sixty-seven percent (67%) of women surveyed at the university-based primary care facility and 69% at the abortion clinic indicated a preference for abortion services from their regular health care provider. A statistically significant association (P = 0.002) was found between comfort speaking with a regular health care provider about pregnancy prevention and preference for the provision of abortion services from a regular health care provider. Women may feel more comfortable undergoing an early abortion procedure with a provider with whom they have an established relationship. The integration of early abortion services into primary care practice may increase continuity of care among women seeking an abortion.

  3. Influence of occlusal loading on peri-implant clinical parameters. A pilot study

    PubMed Central

    Pellicer-Chover, Hilario; Viña-Almunia, José; Romero-Millán, Javier; Peñarrocha-Oltra, David; Peñarrocha-Diago, María

    2014-01-01

    Objectives: To investigate the relation between occlusal loading and peri-implant clinical parameters (probing depth, bleeding on probing, gingival retraction, width of keratinized mucosa, and crevicular fluid volume) in patients with implant-supported complete fixed prostheses in both arches. Material and Methods: This clinical study took place at the University of Valencia (Spain) dental clinic. It included patients attending the clinic for regular check-ups during at least 12 months after rehabilitation of both arches with implant-supported complete fixed ceramo-metallic prostheses. One study implant and one control implant were established for each patient using the T-Scan®III computerized system (Tesco, South Boston, USA). The maxillary implant closest to the point of maximum occlusal loading was taken as the study implant and the farthest (with least loading) as the control. Occlusal forces were registered with the T-Scan® III and then occlusal adjustment was performed to distribute occlusal forces correctly. Peri-implant clinical parameters were analyzed in both implants before and two and twelve months after occlusal adjustment. Results: Before occlusal adjustment, study group implants presented a higher mean volume of crevicular fluid (51.3±7.4 UP) than the control group (25.8±5.5 UP), with statistically significant difference. Two months after occlusal adjustment, there were no significant differences between groups (24.6±3.8 UP and 26±4.5 UP respectively) (p=0.977). After twelve months, no significant differences were found between groups (24.4±11.1 UP and 22.5±8.9 UP respectively) (p=0.323). For the other clinical parameters, no significant differences were identified between study and control implants at any of the study times (p>0.05). Conclusions: Study group implants receiving higher occlusal loading presented significantly higher volumes of crevicular fluid than control implants. Crevicular fluid volumes were similar in both groups two and

  4. Laser photocoagulation (810 nm diode) for threshold retinopathy of prematurity: a prospective randomized pilot study of treatment to ridge and avascular retina versus avascular retina alone.

    PubMed

    Uparkar, Mahesh; Sen, Parveen; Rawal, Ashish; Agarwal, Sumit; Khan, Balbir; Gopal, Lingam

    2011-02-01

    The purpose of this study was to compare the structural outcome of laser treatment to avascular retina and ridge versus laser treatment to avascular retina alone in cases with threshold retinopathy of prematurity (ROP). A prospective, randomized, interventional, comparative study of consecutive cases referred to a single tertiary center was considered here. 50 infants with bilateral symmetrical threshold ROP were recruited into this study over a period of 3 years. Threshold ROP was defined as per CRYO-ROP study. Perinatal history details for all patients including significant maternal history were recorded. One eye of each patient was randomized (Microsoft Excel 2000) to one of the two treatment groups--laser treatment to avascular retina (Group A) or laser treatment to avascular retina and ridge (Group B). Laser treatment was performed with a 810 nm diode laser (Iris Medical Instruments, Inc. Mountain View, CA, USA). Treatment was continued until regression of ROP. Structural outcome was assessed at a minimum follow-up of 6 months and was considered favorable or unfavorable as per the CRYO-ROP study criteria. An unfavorable outcome consisted of either (1) a retinal fold involving the macula; (2) any retinal detachment involving zone 1; or (3) a retrolental mass that obscured visualization of the posterior pole. Secondary outcome measures included the difference in time to regression of ROP and complications of treatment between the two treatment groups. 100 eyes of 50 infants received laser photocoagulation for threshold ROP after randomization (50 eyes in each group). Of these 50 infants, 20 (40%) were female and 30 (60%) were male. A significant proportion of the children (46%) were conceived as twins. The average birth weight was 1360 ± 326 g (range 750-2200 g). The mean gestational age at birth was 30.72 ± 1.6 weeks (range 26-36 weeks). Zone I disease was present in 14 (14%) eyes and zone II in the remaining 86 eyes (86%). Threshold stage retinopathy (CRYO

  5. Clinical and Paraclinical Indicators of Motor System Impairment in Hereditary Spastic Paraplegia: A Pilot Study

    PubMed Central

    Martinuzzi, Andrea; Montanaro, Domenico; Vavla, Marinela; Paparella, Gabriella; Bonanni, Paolo; Musumeci, Olimpia; Brighina, Erika; Hlavata, Hana; Rossi, Giuseppe; Aghakhanyan, Gayane; Martino, Nicola; Baratto, Alessandra; D’Angelo, Maria Grazia; Peruch, Francesca; Fantin, Marianna; Arnoldi, Alessia; Citterio, Andrea; Vantaggiato, Chiara; Rizzo, Vincenzo; Toscano, Antonio; Bresolin, Nereo; Bassi, Maria Teresa

    2016-01-01

    Background Hereditary spastic paraplegias (HSP) are a composite and genetically heterogeneous group of conditions mainly expressed by the impairment of the central motor system (“pure” forms). The involvement of other components of the central nervous system or of other systems is described in the “complicate” forms. The definition of an investigation protocol capable, by assembling clinical and paraclinical indicators to fully represent the extent of the motor system impairment, would help both the clinical handling of these conditions and contribute to our understanding of their pathogenesis. Methods We applied a clinical and paraclinical protocol which included tools exploring motor and non motor functioning, neurophysiology and MRI to a composite cohort of 70 molecularly defined HSP patients aged 3 to 65, to define for each indicator its significance in detailing the presence and the severity of the pathology. Results Clinically increased deep tendon reflexes and lower limb (LL) weakness are constant findings in all patients. The “complicated” forms are characterized by peripheral motor impairment, cognitive and cerebellar involvement. The Spastic Paraplegia Rating Scale efficiently reflects the severity of functional problems and correlates with disease duration. Neurophysiology consistently documents the impairment of the central motor pathway to the LLs. Nevertheless, the upper extremities and sensory system involvement is a frequent finding. MRI diffusion tensor imaging (DTI) highlighted a significant alteration of FA and MD. Combining the sampling of the various portion of the cortico-spinal tract (CST) DTI consistently discriminated patients from controls. Conclusion We propose a graded clinical and paraclinical protocol for HSP phenotype definition, indicating for each tool the discriminative and descriptive capacity. Our protocol applied to 9 different forms of HSP showed that the functional impairment often extends beyond the CST. The novel

  6. Avatar-Mediated Home Safety Assessments: Piloting a Virtual Objective Structured Clinical Examination Station

    PubMed Central

    Andrade, Allen D.; Cifuentes, Pedro; Oliveira, Marcelo C.; Anam, Ramanakumar; Roos, Bernard A.; Ruiz, Jorge G.

    2011-01-01

    Background Avatars and virtual worlds offer medical educators new approaches to assess learners' competency in home-safety assessments that are less time-consuming and more flexible than traditional home visits. We sought to evaluate the feasibility and acceptability of implementing an avatar-mediated, 3-dimensional (3-D) home simulation as a virtual objective structured clinical examination station for geriatric medicine fellows. Methods We developed a 3-D home simulation in the virtual world Second Life (Linden Lab, San Francisco, CA) containing 50 safety hazards that could affect the safety of an elderly person at home. Eight geriatric medicine fellows participated in a 16-station objective structured clinical examination, with one station assigned to the 15-minute 3-D virtual world simulation, where the fellow's “home visit” was performed by navigating his or her avatar in the virtual world simulation. The fellows were instructed to find the home safety hazards in the simulated environment and then provide specific written recommendations. Two reviewers independently scored the fellows' written findings against an inventory-based checklist. Results The geriatric medicine fellows scored a mean of 43% ± SD 9 on the inventory-based checklist. The scoring of the 2 reviewers showed a high interrater reliability (88%). Six of the 8 participants (75%) rated the simulation as “excellent.” Four of the 5 women (80%) and none of the 3 men (20%) participating in the virtual objective structured clinical examination needed navigation assistance in the 3-D virtual house. Conclusion The 3-D, avatar-based, virtual geriatric home safety objective structured clinical examination is a practical and acceptable alternative to the traditional home safety visits in an objective structured clinical examination setting. PMID:23205205

  7. Cardiovascular clinical trials in Japan and controversies regarding prospective randomized open-label blinded end-point design.

    PubMed

    Kohro, Takahide; Yamazaki, Tsutomu

    2009-02-01

    Recently, results of several cardiovascular clinical trials conducted in Japan were published. Most of them were designed as prospective randomized open-label blinded end-point (PROBE)-type trials, in which patients were randomly allocated to different regimens and both the patients and doctors are aware of the regimen being administered. Although the PROBE design enables performing trials resembling real-world practices, entails low costs and renders patient recruitment easier, it presents several conditions that have to be satisfied to acquire accurate results, due to its open-label nature. Principally, the so-called hard end points, which are judged by objective criteria, should be used as primary end points in order to prevent biases. In this article, a general description of various designs of clinical studies is provided, followed by a description of the PROBE design, and the precautions to be taken while conducting PROBE-designed trials by comparing trials conducted in Japan and the West.

  8. Remote Source Document Verification in Two National Clinical Trials Networks: A Pilot Study

    PubMed Central

    Mealer, Meredith; Kittelson, John; Thompson, B. Taylor; Wheeler, Arthur P.; Magee, John C.; Sokol, Ronald J.; Moss, Marc; Kahn, Michael G.

    2013-01-01

    Objective Barriers to executing large-scale randomized controlled trials include costs, complexity, and regulatory requirements. We hypothesized that source document verification (SDV) via remote electronic monitoring is feasible. Methods Five hospitals from two NIH sponsored networks provided remote electronic access to study monitors. We evaluated pre-visit remote SDV compared to traditional on-site SDV using a randomized convenience sample of all study subjects due for a monitoring visit. The number of data values verified and the time to perform remote and on-site SDV was collected. Results Thirty-two study subjects were randomized to either remote SDV (N=16) or traditional on-site SDV (N=16). Technical capabilities, remote access policies and regulatory requirements varied widely across sites. In the adult network, only 14 of 2965 data values (0.47%) could not be located remotely. In the traditional on-site SDV arm, 3 of 2608 data values (0.12%) required coordinator help. In the pediatric network, all 198 data values in the remote SDV arm and all 183 data values in the on-site SDV arm were located. Although not statistically significant there was a consistent trend for more time consumed per data value (minutes +/- SD): Adult 0.50 +/- 0.17 min vs. 0.39 +/- 0.10 min (two-tailed t-test p=0.11); Pediatric 0.99 +/- 1.07 min vs. 0.56 +/- 0.61 min (p=0.37) and time per case report form: Adult: 4.60 +/- 1.42 min vs. 3.60 +/- 0.96 min (p=0.10); Pediatric: 11.64 +/- 7.54 min vs. 6.07 +/- 3.18 min (p=0.10) using remote SDV. Conclusions Because each site had different policies, requirements, and technologies, a common approach to assimilating monitors into the access management system could not be implemented. Despite substantial technology differences, more than 99% of data values were successfully monitored remotely. This pilot study demonstrates the feasibility of remote monitoring and the need to develop consistent access policies for remote study monitoring. PMID

  9. Clinical outcomes of two main variants of progressive supranuclear palsy and multiple system atrophy: a prospective natural history study.

    PubMed

    Jecmenica-Lukic, Milica; Petrovic, Igor N; Pekmezovic, Tatjana; Kostic, Vladimir S

    2014-08-01

    Progressive supranuclear palsy (PSP) and parkinsonian subtype of multiple system atrophy (MSA-P) are, after Parkinson's disease (PD), the most common forms of neurodegenerative parkinsonism. Clinical heterogeneity of PSP includes two main variants, Richardson syndrome (PSP-RS) and PSP-parkinsonism (PSP-P). Clinical differentiation between them may be impossible at least during the first 2 years of the disease. Little is known about the differences in natural course of PSP-RS and PSP-P and, therefore, in this study we prospectively followed the clinical outcomes of consecutive, pathologically unconfirmed patients with the clinical diagnoses of PSP-RS (51 patients), PSP-P (21 patients) and MSA-P (49 patients). Estimated mean survival time was 11.2 years for PSP-P, 6.8 years for PSP-RS, and 7.9 years for MSA-P, where a 5-year survival probabilities were 90, 66 and 78 %, respectively. More disabling course of PSP-RS compared to PSP-P was also highlighted through the higher number of milestones reached in the first 3 years of the disease, as well as in the trend to reach all clinical milestones earlier. We found that PSP-P variant had a more favorable course with longer survival, not only when compared to PSP-RS, but also when compared to another form of atypical parkinsonism, MSA-P.

  10. Health literacy screening of patients attending a student-led osteopathy clinic: A pilot investigation.

    PubMed

    Vaughan, Brett; Mulcahy, Jane; Fitzgerald, Kylie

    2016-08-01

    Adequate levels of health literacy (HL) are required for patients to access appropriate health services and develop an understanding of the options for managing their healthcare needs. There is limited literature on HL of patients seeking care for a musculoskeletal complaint. The present study sought to screen the HL of patients presenting to an Australian osteopathy student-led clinic using a single screening question 'Are you confident completing medical forms?'. Less than 10% of patients attending the clinic were considered to have below adequate levels of HL using this question, consistent with other work in Australian populations. Logistic regression analysis identified that the most significant demographic variables associated with lower HL were patients who did not speak English at home, those with lower education levels, and those who were less satisfied with their life. Evaluation of a patients' HL may assist practitioners to improve patient education and management strategies.

  11. Transforming the Primary Care Training Clinic: New York State’s Hospital Medical Home Demonstration Pilot

    PubMed Central

    Angelotti, Marietta; Bliss, Kathryn; Schiffman, Dana; Weaver, Erin; Graham, Laura; Lemme, Thomas; Pryor, Veronica; Gesten, Foster C.

    2015-01-01

    Background Training in patient-centered medical home (PCMH) settings may prepare new physicians to measure quality of care, manage the health of populations, work in teams, and include cost information in decision making. Transforming resident clinics to PCMHs requires funding for additional staff, electronic health records, training, and other resources not typically available to residency programs. Objective Describe how a 1115 Medicaid waiver was used to transform the majority of primary care training sites in New York State to the PCMH model and improve the quality of care provided. Methods The 2013–2014 Hospital Medical Home Program provided awards to 60 hospitals and 118 affiliated residency programs (training more than 5000 residents) to transform outpatient sites into PCMHs and provide high-quality, coordinated care. Site visits, coaching calls, resident surveys, data reporting, and feedback were used to promote and monitor change in resident continuity and quality of care. Descriptive analyses measured improvements in these areas. Results A total of 156 participating outpatient sites (100%) received PCMH recognition. All sites enhanced resident education using PCMH principles through patient empanelment, development of quality dashboards, and transforming resident scheduling and training. Clinical quality outcomes showed improvement across the demonstration, including better performance on colorectal and breast cancer screening rates (rate increases of 13%, P ≤ .001, and 11%, P = .011, respectively). Conclusions A 1115 Medicaid waiver is a viable mechanism for states to transform residency clinics to reflect new primary care models. The PCMH transformation of 156 sites led to improvements in resident continuity and clinical outcomes. PMID:26221444

  12. Objective Bayesian fMRI analysis—a pilot study in different clinical environments

    PubMed Central

    Magerkurth, Joerg; Mancini, Laura; Penny, William; Flandin, Guillaume; Ashburner, John; Micallef, Caroline; De Vita, Enrico; Daga, Pankaj; White, Mark J.; Buckley, Craig; Yamamoto, Adam K.; Ourselin, Sebastien; Yousry, Tarek; Thornton, John S.; Weiskopf, Nikolaus

    2015-01-01

    Functional MRI (fMRI) used for neurosurgical planning delineates functionally eloquent brain areas by time-series analysis of task-induced BOLD signal changes. Commonly used frequentist statistics protect against false positive results based on a p-value threshold. In surgical planning, false negative results are equally if not more harmful, potentially masking true brain activity leading to erroneous resection of eloquent regions. Bayesian statistics provides an alternative framework, categorizing areas as activated, deactivated, non-activated or with low statistical confidence. This approach has not yet found wide clinical application partly due to the lack of a method to objectively define an effect size threshold. We implemented a Bayesian analysis framework for neurosurgical planning fMRI. It entails an automated effect-size threshold selection method for posterior probability maps accounting for inter-individual BOLD response differences, which was calibrated based on the frequentist results maps thresholded by two clinical experts. We compared Bayesian and frequentist analysis of passive-motor fMRI data from 10 healthy volunteers measured on a pre-operative 3T and an intra-operative 1.5T MRI scanner. As a clinical case study, we tested passive motor task activation in a brain tumor patient at 3T under clinical conditions. With our novel effect size threshold method, the Bayesian analysis revealed regions of all four categories in the 3T data. Activated region foci and extent were consistent with the frequentist analysis results. In the lower signal-to-noise ratio 1.5T intra-operative scanner data, Bayesian analysis provided improved brain-activation detection sensitivity compared with the frequentist analysis, albeit the spatial extents of the activations were smaller than at 3T. Bayesian analysis of fMRI data using operator-independent effect size threshold selection may improve the sensitivity and certainty of information available to guide neurosurgery

  13. Multiday Transcranial Direct Current Stimulation Causes Clinically Insignificant Changes in Childhood Dystonia: A Pilot Study.

    PubMed

    Bhanpuri, Nasir H; Bertucco, Matteo; Young, Scott J; Lee, Annie A; Sanger, Terence D

    2015-10-01

    Abnormal motor cortex activity is common in dystonia. Cathodal transcranial direct current stimulation may alter cortical activity by decreasing excitability while anodal stimulation may increase motor learning. Previous results showed that a single session of cathodal transcranial direct current stimulation can improve symptoms in childhood dystonia. Here we performed a 5-day, sham-controlled, double-blind, crossover study, where we measured tracking and muscle overflow in a myocontrol-based task. We applied cathodal and anodal transcranial direct current stimulation (2 mA, 9 minutes per day). For cathodal transcranial direct current stimulation (7 participants), 3 subjects showed improvements whereas 2 showed worsening in overflow or tracking error. The effect size was small (about 1% of maximum voluntary contraction) and not clinically meaningful. For anodal transcranial direct current stimulation (6 participants), none showed improvement, whereas 5 showed worsening. Thus, multiday cathodal transcranial direct current stimulation reduced symptoms in some children but not to a clinically meaningful extent, whereas anodal transcranial direct current stimulation worsened symptoms. Our results do not support transcranial direct current stimulation as clinically viable for treating childhood dystonia.

  14. Qualitative outcome assessment of a medical ethics program for clinical clerkships: a pilot study.

    PubMed

    Hayes, R P; Stoudemire, A; Kinlaw, K; Dell, M L; Loomis, A

    1999-01-01

    This study assessed the usefulness of an open-ended case analysis test instrument for evaluating the effects of a 1-year ethics course on medical students' decision-making skills. Through case-oriented seminars in gynecology, internal medicine, obstetrics, pediatrics, psychiatry, and surgery, third-year medical students were taught a structured analytic framework for analyzing clinical ethical problems stressing the interactive relationships among medical indications, patient preferences, quality of life, and contextual (social, legal, economic) matters. At precourse, the students were given a test case and asked to provide a line of reasoning for their clinical decisions. At postcourse, the students were given the same case. Content analysis of pre- and postcourse responses of a random student sample revealed increases in student awareness in the following areas: 1) consideration of informed consent, 2) professional liability, 3) physician-assisted suicide, and 4) resource utilization. With some modifications, open-ended case analysis holds promise for evaluating medical ethics courses. The authors make recommendations for future research in evaluating the true impact of clinical ethics courses in medical education.

  15. Comparison between full face and hemifacial CBCT cephalograms in clinically symmetrical patients: a pilot study

    PubMed Central

    Junqueira, Cintia Helena Zingaretti; Janson, Guilherme; Junqueira, Marisa Helena Zingaretti; Mendes, Lucas Marzullo; Favilla, Eduardo Esberard; Garib, Daniela Gamba

    2015-01-01

    INTRODUCTION: One of the advantages of cone-beam computed tomography (CBCT) is the possibility of obtaining images of conventional lateral cephalograms derived from partial or complete reconstruction of facial images. OBJECTIVE: This study aimed at comparing full face, right and left hemifacial CBCT cephalograms of orthodontic patients without clinical facial asymmetry. METHODS: The sample comprised nine clinically symmetrical patients who had pretreament full face CBCT. The CBCTs were reconstructed so as to obtain full face, right and left hemifacial cephalograms. Two observers, at two different times, obtained linear and angular measurements for the images using Dolphin 3D software. Dependent and independent t-tests were used to assess the reproducibility of measurements. Analysis of Variance and Kruskal-Wallis tests were used to compare the variables obtained in the CBCT derived cephalometric views. RESULTS: There was good reproducibility for CBCT scans and no statistically significant differences between measurements of full face, right and left hemifacial CBCT scans. CONCLUSIONS: Cephalometric measurements in full face, right and left hemifacial CBCT scans in clinically symmetrical patients are similar. PMID:25992992

  16. Asian diabetics attending a British hospital clinic: a pilot study to evaluate their care.

    PubMed Central

    Hawthorne, K

    1990-01-01

    A questionnaire survey of 40 Asian and 31 British non-insulin dependent diabetics attending a hospital clinic showed that both groups remembered receiving education about diabetes (90%) but Asian diabetics knew less about glucose monitoring and diabetic complications. Asians also had a more negative attitude towards the clinic, feeling they were made to wait longer than the British. They were frustrated by a lack of communication with the staff. Forty per cent of both Asian and British diabetics felt that diabetes prevented them from leading a normal lifestyle. Twenty seven per cent of both Asian and British diabetics used herbal or alternative medicines, but Asians differed in that they used these medicines specifically for diabetes. A further sample of 50 Asians had poorer glycaemic control than a sample of British diabetics matched for age, sex and type of diabetes. It is concluded that despite receiving the same education as British diabetics, Asians did not understand it as well. The education was often not relevant to their diets or customs. This may contribute to their poorer glycaemic control. Diabetic clinic facilities need to be improved for Asian diabetics, to improve their understanding of diabetes. PMID:2117948

  17. Development of training-related health care software by a team of clinical educators: their experience, from conception to piloting

    PubMed Central

    ap Dafydd, Derfel; Williamson, Ruth; Blunt, Philip; Blunt, Dominic M

    2016-01-01

    The difficulties of producing useful, bespoke, and affordable information technology systems for large health care organizations are well publicized, following several high-profile endeavors in the UK. This article describes the experience of a small group of clinical radiologists and their collaborators in producing an information technology system – from conception to piloting. This system, called Trainee Tracker, enables automated target date recalculation of trainee milestones, depending on their work patterns and other individual circumstances. It utilizes an automated email alert system to notify the educational supervisors and trainees of approaching and elapsed target dates, in order to identify trainees in difficulty early and address their training needs accordingly. The challenges and advantages, both common to and contrasting with larger-scale projects, are also considered. The benefits of the development team’s “agile” approach to software development and the lessons learned will be of interest to medical educators, particularly those with expertise in e-portfolios and other training-related software. PMID:27853396

  18. Effect of safety education on classmates of injured children: a prospective clinical trial.

    PubMed

    Cook, Becky S; Ricketts, Crystal D; Brown, Rebeccah L; Garcia, Victor F; Falcone, Richard A

    2006-01-01

    We hypothesized that using the teachable moment associated with an injured classmate, school-aged children would demonstrate improved retention of injury prevention education. The injured child's class and one control with presentation class received an injury prevention presentation. Prospective evaluation was performed using pre, immediate post, and 1-month posttesting. Immediately following the presentation, 83% of classes in both groups demonstrated significant improvement in test scores. At 1 month, 100% of the injured child's and only 66% of control with presentation classrooms maintained significant improvements. This unique program results not only in immediate but also in long-term retention of injury prevention information.

  19. Simulation-guided cardiac auscultation improves medical students' clinical skills: the Pavia pilot experience.

    PubMed

    Perlini, Stefano; Salinaro, Francesco; Santalucia, Paola; Musca, Francesco

    2014-03-01

    Clinical evaluation is the cornerstone of any cardiac diagnosis, although excessive over-specialisation often leads students to disregard the value of clinical skills, and to overemphasize the approach to instrumental cardiac diagnosis. Time restraints, low availability of "typical" cardiac patients on whom to perform effective bedside teaching, patients' respect and the underscoring of the value of clinical skills all lead to a progressive decay in teaching. Simulation-guided cardiac auscultation may improve clinical training in medical students and residents. Harvey(©) is a mannequin encompassing more than 50 cardiac diagnoses that was designed and developed at the University of Miami (Florida, USA). One of the advantages of Harvey(©) simulation resides in the possibility of listening, comparing and discussing "real" murmurs. To objectively assess its teaching performance, the capability to identify five different cardiac diagnoses (atrial septal defect, normal young subject, mitral stenosis with tricuspid regurgitation, chronic mitral regurgitation, and pericarditis) out of more than 50 diagnostic possibilities was assessed in 523 III-year medical students (i.e. at the very beginning of their clinical experience), in 92 VI-year students, and in 42 residents before and after a formal 10-h teaching session with Harvey(©). None of them had previously experienced simulation-based cardiac auscultation in addition to formal lecturing (all three groups) and bedside teaching (VI-year students and residents). In order to assess the "persistence" of the acquired knowledge over time, the test was repeated after 3 years in 85 students, who did not repeat the formal 10-h teaching session with Harvey(©) after the III year. As expected, the overall response was poor in the "beginners" who correctly identified 11.0 % of the administered cardiac murmurs. After simulation-guided training, the ability to recognise the correct cardiac diagnoses was much better (72.0 %; p < 0

  20. Pilot clinical observations between food and drug seeking derived from fifty cases attending an eating disorder clinic

    PubMed Central

    Beitscher-Campbell, Harriet; Blum, Kenneth; Febo, Marcelo; Madigan, Margaret A.; Giordano, John; Badgaiyan, Rajendra D.; Braverman, Eric R.; Dushaj, Kristina; Li, Mona; Gold, Mark S.

    2016-01-01

    Background The reward deficiency syndrome hypothesis posits that genes are responsible for reward dependence and related behaviors. There is evidence that both bulimia and anorexia nervosa, especially in women, have been linked to a lifetime history of substance use disorder (SUD). There are difficulties in accepting food as an addiction similar to drugs; however, increasingly neuroimaging studies favor such an assertion. Case presentations We are reporting the evidence of comorbidity of eating disorders with SUD found within these case presentations. We show 50 case reports derived from two independent treatment centers in Florida that suggest the commonality between food and drug addictions. In an attempt to provide data from this cohort, many participants did not adequately respond to our questionnaire. Discussion We propose that dopamine agonist therapy may be of common benefit. Failure in the past may reside in too powerful D2 agonist activity leading to D2 receptor downregulation, while the new methodology may cause a reduction of “dopamine resistance” by inducing “dopamine homeostasis.” While this is not a definitive study, it does provide some additional clinical evidence that these two addictions are not mutually exclusive. Conclusion Certainly, it is our position that there is an overlap between food- and drug-seeking behavior. We propose that the studies focused on an effort to produce natural activation of dopaminergic reward circuitry as a type of common therapy may certainly be reasonable. Additional research is warranted. PMID:27502054

  1. Pilot clinical observations between food and drug seeking derived from fifty cases attending an eating disorder clinic.

    PubMed

    Beitscher-Campbell, Harriet; Blum, Kenneth; Febo, Marcelo; Madigan, Margaret A; Giordano, John; Badgaiyan, Rajendra D; Braverman, Eric R; Dushaj, Kristina; Li, Mona; Gold, Mark S

    2016-09-01

    Background The reward deficiency syndrome hypothesis posits that genes are responsible for reward dependence and related behaviors. There is evidence that both bulimia and anorexia nervosa, especially in women, have been linked to a lifetime history of substance use disorder (SUD). There are difficulties in accepting food as an addiction similar to drugs; however, increasingly neuroimaging studies favor such an assertion. Case presentations We are reporting the evidence of comorbidity of eating disorders with SUD found within these case presentations. We show 50 case reports derived from two independent treatment centers in Florida that suggest the commonality between food and drug addictions. In an attempt to provide data from this cohort, many participants did not adequately respond to our questionnaire. Discussion We propose that dopamine agonist therapy may be of common benefit. Failure in the past may reside in too powerful D2 agonist activity leading to D2 receptor downregulation, while the new methodology may cause a reduction of "dopamine resistance" by inducing "dopamine homeostasis." While this is not a definitive study, it does provide some additional clinical evidence that these two addictions are not mutually exclusive. Conclusion Certainly, it is our position that there is an overlap between food- and drug-seeking behavior. We propose that the studies focused on an effort to produce natural activation of dopaminergic reward circuitry as a type of common therapy may certainly be reasonable. Additional research is warranted.

  2. An objective structured clinical examination for the licentiate: report of the pilot project of the Medical Council of Canada.

    PubMed

    Reznick, R; Smee, S; Rothman, A; Chalmers, A; Swanson, D; Dufresne, L; Lacombe, G; Baumber, J; Poldre, P; Levasseur, L

    1992-08-01

    The Medical Council of Canada (MCC) administers a qualifying examination for the issuance of a license to practice medicine. To date, this examination does not test the clinical skills of history taking, physical examination, and communication. The MCC is implementing an objective structured clinical examination (OSCE) to test these skills in October 1992. A pilot examination was developed to test the feasibility, reliability, and validity of running a multisite, two-form, four-hour, 20-station OSCE for national licensure. In February 1991, 240 volunteer first- and second-year residents were tested at four sites. The candidates were randomly assigned to one of two forms of the test and one of two sites for two of the four sites. Generalizability analysis revealed that the variance due to form was 0.0 and that due to site was .16 compared with a total variance of 280.86. The reliabilities (inter-station) were .56 and .60 for the two forms. Station total-test score correlations, used to measure station validity, were significant for 38 of the 40 stations used (range .14-.60). The results of the OSCE correlated moderately with the MCC qualifying examination; these correlations were .32 and .35 for the two test forms. Content validity was assessed by postexamination questionnaires given to the physician examiners using a scale of 0 (low) to 10 (high). The physicians' mean ratings were: importance of the stations, 8.1 (SD, 1.8); success of the examination in testing core skills, 8.1 (SD, 1.6); and degree of challenge, 7.8 (SD, 2.1). The results indicate that a full-scale national administration of an OSCE for licensure is feasible using the model developed. Aspects of validity have been established and strategies to augment reliability have been developed.

  3. An early oral health care program starting during pregnancy: results of a prospective clinical long-term study.

    PubMed

    Meyer, Karen; Geurtsen, Werner; Günay, Hüsamettin

    2010-06-01

    This study covers phase IV of a prospective clinical long-term study. Objective of this clinical investigation was to analyze the effects of a long-term prevention program on dental and oral health of teenagers at the age of 13 to 14 years. The entire study was subdivided into four phases. Phase I comprised an individual preventive care during pregnancy ("primary-primary prevention"); phase II assessed mothers and their young children until the age of 3 years ("primary prevention"); and in phase III, mothers and children at the age of 6 years were investigated. In phase IV of the study, the oral health of 13- to 14-year-old teenagers was examined (13.4 +/- 0.5 years; n = 29). All phases consisted of an examination, education about oral health care, and treatment based on the concept of an early oral health care promotion. The control group consisted of randomly selected adolescents at the same age (n = 30). The following clinical parameters were assessed: decayed/missing/filled teeth (DMF-T)/decayed, missing, and filled surface teeth index, hygiene index, papilla bleeding index, Periodontal Screening Index, and Streptococcus mutans/Lactobacillus concentration in saliva. The teenagers of the "prevention" group of phase IV of our prospective study revealed a share of 89.7% caries-free dentitions (65.5% sound; 24.2% caries-free with fillings). Mean DMF-T was 0.55 +/- 1.0. The control group showed a significantly higher mean DMF-T of 1.5 +/- 1.5 (p < 0.05) and revealed 56.7% of caries-free dentitions (30% sound, 26.7% caries-free with restorations). Our data clearly document that an early oral health care promotion starting during pregnancy may cause a sustained and long-term improvement of the oral health of children.

  4. Nailfold Videocapillaroscopic Features and Other Clinical Risk Factors for Digital Ulcers in Systemic Sclerosis: A Multicenter, Prospective Cohort Study

    PubMed Central

    Herrick, Ariane L.; Distler, Oliver; Becker, Mike O.; Beltran, Emma; Carpentier, Patrick; Ferri, Clodoveo; Inanç, Murat; Vlachoyiannopoulos, Panayiotis; Chadha‐Boreham, Harbajan; Cottreel, Emmanuelle; Pfister, Thomas; Rosenberg, Daniel; Torres, Juan V.; Cutolo, Maurizio; Herrick, Ariane L.; Distler, Oliver; Becker, Mike; Beltran, Emma; Carpentier, Patrick; Ferri, Clodoveo; Inanç, Murat; Vlachoyiannopoulos, Panayiotis; Smith, Vanessa; Erlacher, L; Hirschl, M; Kiener, HP; Pilger, E; Smith, V; Blockmans, D; Wautrecht, J‐C; Becvár, R; Carpentier, P; Frances, C; Lok, C; Sparsa, A; Hachulla, E; Quere, I; Allanore, Y; Agard, C; Riemekasten, G; Hunzelmann, N; Stücker, M; Ahmadi‐Simab, K; Sunderkötter, C; Wohlrab, J; Müller‐Ladner, U; Schneider, M; Vlachoyianopoulos, P; Vassilopoulos, D; Drosos, A; Antonopoulos, A; Balbir‐Gurman, A; Langevitz, P; Rosner, I; Levy, Y; Cutolo, M; Bombardieri, S; Ferraccioli, G; Mazzuca, S; Grassi, W; Lunardi, C; Airó, P; Riccieri, V; Voskuyl, AE; Schuerwegh, A; Santos, L; Rodrigues, AC; Grilo, A; Amaral, MC; Román Ivorra, JA; Castellvi, I; Distler, O; Spertini, F; Müller, R; Inanç, M; Oksel, F; Turkcapar, N; Herrick, A; Denton, C; McHugh, N; Chattopadhyay, C; Hall, F; Buch, M

    2016-01-01

    Objective To identify nailfold videocapillaroscopic features and other clinical risk factors for new digital ulcers (DUs) during a 6‐month period in patients with systemic sclerosis (SSc). Methods In this multicenter, prospective, observational cohort study, the videoCAPillaroscopy (CAP) study, we evaluated 623 patients with SSc from 59 centers (14 countries). Patients were stratified into 2 groups: a DU history group and a no DU history group. At enrollment, patients underwent detailed nailfold videocapillaroscopic evaluation and assessment of demographic characteristics, DU status, and clinical and SSc characteristics. Risk factors for developing new DUs were assessed using univariable and multivariable logistic regression (MLR) analyses. Results Of the 468 patients in the DU history group (mean ± SD age 54.0 ± 13.7 years), 79.5% were female, 59.8% had limited cutaneous SSc, and 22% developed a new DU during follow‐up. The strongest risk factors for new DUs identified by MLR in the DU history group included the mean number of capillaries per millimeter in the middle finger of the dominant hand, the number of DUs (categorized as 0, 1, 2, or ≥3), and the presence of critical digital ischemia. The receiver operating characteristic (ROC) of the area under the curve (AUC) of the final MLR model was 0.738 (95% confidence interval [95% CI] 0.681–0.795). Internal validation through bootstrap generated a ROC AUC of 0.633 (95% CI 0.510–0.756). Conclusion This international prospective study, which included detailed nailfold videocapillaroscopic evaluation and extensive clinical characterization of patients with SSc, identified the mean number of capillaries per millimeter in the middle finger of the dominant hand, the number of DUs at enrollment, and the presence of critical digital ischemia at enrollment as risk factors for the development of new DUs. PMID:27111549

  5. [The significance, development and prospects of healthcare data integration in new drug clinical trials].

    PubMed

    Cai, Hong-wei; Li, Yan-hong; Zhang, Zi-bao; Deng, Ya-zhong

    2015-11-01

    With the deployment of electronic medical records systems, more and more routine clinical data are recorded electronically, which become a potential data source for new drug clinical trials. In this paper, we summarized the opportunities, challenges, obstacles and the latest development in this field.

  6. Effects of youth football on selected clinical measures of neurologic function: a pilot study.

    PubMed

    Munce, Thayne A; Dorman, Jason C; Odney, Tryg O; Thompson, Paul A; Valentine, Verle D; Bergeron, Michael F

    2014-12-01

    We assessed 10 youth football players (13.4 ± 0.7 y) immediately before and after their season to explore the effects of football participation on selected clinical measures of neurologic function. Postseason postural stability in a closed-eye condition was improved compared to preseason (P = .017). Neurocognitive testing with the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery revealed that reaction time was significantly faster at postseason (P = .015). There were no significant preseason versus postseason differences in verbal memory (P = .507), visual memory (P = .750), or visual motor speed (P = .087). Oculomotor performance assessed by the King-Devick test was moderately to significantly improved (P = .047-.115). A 12-week season of youth football did not impair the postural stability, neurocognitive function, or oculomotor performance measures of the players evaluated. Though encouraging, continued and more comprehensive investigations of this at-risk population are warranted.

  7. Contact Lens Care Solutions: A Pilot Study of Ethnic Differences in Clinical Signs and Symptoms

    PubMed Central

    Lin, Meng C.; Yuen, Jenny; Graham, Andrew D.

    2014-01-01

    Objectives To determine whether Asian and Caucasian subjects differ in clinical signs or subjective symptoms in response to use of different biguanide-preserved contact lens care solutions. Methods Forty-two subjects (15 Asian, 27 Caucasian) wearing lotrafilcon B silicone hydrogel contact lenses used a preservative-free lens care solution (Clear Care®, CIBA VISION, Atlanta, GA, USA) bilaterally for 2 weeks, then used 2 biguanide-preserved solutions (Solution 1: ReNu MPS®, Bausch & Lomb, Rochester, NY, USA; Solution 2: AQuify MPS®, CIBA VISION, Atlanta, GA, USA) contralaterally in randomly assigned eyes for 4 weeks. Comprehensive ocular surface exams were performed and symptomatology questionnaires were administered every 2 weeks. Investigators were masked as to solution assignment during examinations, while subjects were not in order to avoid potential difficulties in compliance with the protocol. Results With Solution 1, the majority of both Asian and Caucasian subjects had grade 2 or greater corneal staining after 2 weeks (67% and 59%, respectively) and 4 weeks (60% and 67%, respectively). With Solution 2, grade 2 or greater corneal staining occurred in 40% of Asians after 2 weeks and in 13% after 4 weeks, but in only 4% of Caucasians after 2 weeks and 0% after 4 weeks. Caucasians reported significantly better average comfort (p = 0.046) and less dryness (p < 0.001) than did Asians. Conclusions Asians and Caucasians differ in both ocular response to use of contact lens care solutions and in reporting of subjective symptoms. Racial and ethnic differences should be considered when evaluating and treating contact lens patients in a clinical setting. PMID:24887209

  8. 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.

  9. Clinical questions raised by providers in the care of older adults: a prospective observational study

    PubMed Central

    Del Fiol, Guilherme; Weber, Alice I; Brunker, Cherie P; Weir, Charlene R

    2014-01-01

    Objective To characterise clinical questions raised by providers in the care of complex older adults in order to guide the design of interventions that can help providers answer these questions. Materials and methods To elicit clinical questions, we observed and audio recorded outpatient visits at three healthcare organisations. At the end of each appointment, providers were asked to identify clinical questions raised in the visit. Providers rated their questions based on their urgency, importance to the patient's care and difficulty in finding a useful answer to. Transcripts of the audio recordings were analysed to identify ageing-specific factors that may have contributed to the nature of the questions. Results We observed 36 patient visits with 10 providers at the three study sites. Providers raised 70 clinical questions (median of 2 clinical questions per patient seen; range 0–12), pursued 50 (71%) and successfully answered 34 (68%) of the questions they pursued. Overall, 36 (51%) of providers’ questions were not answered. Over one-third of the questions were about treatment alternatives and adverse effects. All but two clinical questions were motivated either directly or indirectly by issues related to ageing, such as the normal physiological changes of ageing and diseases with higher prevalence in the elderly. Conclusions The frequency of clinical questions was higher than in previous studies conducted in general primary care patient populations. Clinical questions were predominantly influenced by ageing-related issues. We propose a series of recommendations that may be used to guide the design of solutions to help providers answer their clinical questions in the care of older adults. PMID:24996915

  10. 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.

  11. A Pilot Study to Validate the Burn Center Pediatric Early Warning Score Tool in Clinical Practice.

    PubMed

    Rahman, Zahra H; Leahy, Nicole E; Sessler, Kelly; Greenway, Andrew; Sorensen, Logan; Breznak, Kara; Rabbitts, Angela; Macklay, Holly; Yurt, Roger W

    2016-01-01

    The pediatric early warning score (PEWS) tool helps providers to detect subtle clinical deterioration in non-intensive care unit pediatric patients and intervene early to prevent significant adverse outcomes. Although widely used in general pediatrics, limited studies report on its validation; none report on use with burn-injured patients. New York-Presbyterian/Weill Cornell Medical Center modified a general PEWS system to a burn-specific PEWS and integrated its use into standard practice. This study investigated the external validity of the PEWS process in clinical practice. Fifty cases of patients aged 0 to 15.9 years admitted between January 2012 and June 2013, whose length of stay (LOS) more than 3 days were selected for review from this cohort of n equal to 187. Demographics, total PEWS and score changes, and compliance with PEWS documentation and with resultant interventions were reviewed. Continuous variables are presented as mean ± SD, P less than 0.05. Mean age, burn size, and LOS were 3.2 ± 3.3 years, 4.8 ± 5.7%, and 9.8 ± 7.0 days; 26% required grafting, and 50% were male. No mortalities occurred. One thousand six hundred and twelve PEWS from 1745 opportunities were documented (92.4%). For all PEWS (n = 1612) and PEWS greater than 0 (n = 912), means were 0.9 ± 1.2 and 1.6 ± 1.2, respectively. Among the 162 PEWS increase events, intake (54.1%) and output (4.5%) parameters increased most commonly. Of these, 129 PEWS increases (79.6%) were followed by an intervention that most commonly included text notation of score increase (93.7%), physician/physician assistant notification (70.5%), and feeding-tube insertion (25.6%). Patients with PEWS greater than 0 had similar age, LOS, and larger burn size (5.2% vs 1.4%, P < 0.05) than those with PEWS equal to 0. Compliance with PEWS performance and resultant actions based on score increases are high. Data support that even small changes in burn-injury specific PEWS stimulate provider discussion and

  12. Clinical epidemiology of Guillain-Barré syndrome in adults in Sweden 1996-97: a prospective study.

    PubMed

    Cheng, Q; Jiang, G X; Press, R; Andersson, M; Ekstedt, B; Vrethem, M; Liedholm, L J; Lindsten, H; Brattström, L; Fredrikson, S; Link, H; de Pedro-Cuesta, J

    2000-11-01

    We described clinical manifestations, outcomes, prognostic indicators and clinico-epidemiological subgroups for 53 adult patients with Guillain-Barré syndrome (GBS) in Sweden during the period 1996-97. These patients were identified from a population of 2.8 million inhabitants and prospectively followed up for one year by a network of neurologists. An additional 10 cases, of whom five were adults who had not been prospectively followed up, were not included in the analyses. At 6 months after onset 80% of the patients could walk without aid, while at 1 year 46% were fully recovered, 42% had mild residual signs or symptoms, 4% had moderate and 6% severe disabilities, and 2% had died. Intravenous human immunoglobulin or plasmapheresis were used in 72% of the patients. The sum of the Medical Research Council (MRC) score at nadir was found as the only significant predictor for residual signs at 1 year in a multivariate model. Three subgroups, with different clinico-epidemiological characteristics, were identified by using cluster analysis. In conclusion, GBS in Sweden is frequently preceded by a respiratory infection, is often treated with immunomodulatory therapies, and exhibits a high recovery rate and a low fatality rate.

  13. Comparison between lengthening over nail and conventional Ilizarov lengthening: a prospective randomized clinical study.

    PubMed

    El-Husseini, Timour F; Ghaly, Nabil A M; Mahran, Mahmoud A; Al Kersh, Mohamed Ahmed; Emara, Khaled M

    2013-08-01

    The aim of this study is to compare lengthening over an intramedullary nail to the conventional Ilizarov method with regard to percentage length increase, external fixation index, consolidation index and incidence of complications. This is a prospective randomized controlled study. Thirty-one limbs in 28 patients were included in the study; 15 were lengthened over an intramedullary nail, and 16 limbs were lengthened conventionally. The mean duration of external fixation in the lengthening over nail group was 52.2 days compared to 180.4 days in the conventional group. There was higher incidence of complications in the conventional method group. In comparison with conventional Ilizarov lengthening, lengthening over an intramedullary nail offers a shorter period of external fixation and fewer complications overall, but there is a high incidence of deep intramedullary infection which is serious.

  14. Implementation, testing and pilot clinical evaluation of superelastic splints that decrease joint stiffness.

    PubMed

    Pittaccio, Simone; Garavaglia, L; Viscuso, S; Beretta, E; Strazzer, S

    2013-09-01

    The present work aims at demonstrating that a customised choice of shape memory alloy (SMA) composition, thermo-mechanical treatment and shaping can lead to effective rehabilitation devices applicable to sub-acute and chronic spastic paresis in paediatric patients. SMA pseudoelasticity is regarded as a means to implement a corrective action on posture without hindering residual voluntary or reflex mobility of the affected limb. Specific hinges containing NiTi or NiTiNb elements were designed and constructed to transfer pseudoelastic recovery force to fitted splints for the elbow or the ankle joint. The devices were mechanically tested and showed complete stability after 20-100 cycles, and unchanged characteristics after 1000 full-range deflections. Repositioning splints equipped with patient-specific pseudoelastic hinges were prescribed to 25 individuals (aged 7.75 ± 5.40 years) with mild to severe spastic tetraparesis. Clinical and instrumental evaluations were carried out during crossover trials with traditional and pseudoelastic splints. The sequence of treatment steps was randomized for each subject. The results show that, compared to fixed-angle braces, pseudoelastic devices decrease passive joint stiffness while providing the same control on limb posture. Dynamic pseudoelastic braces are therefore an innovative treatment for spastic paresis, which may reduce joint stiffness.

  15. A sleep bruxism detection system based on sensors in a splint - pilot clinical data.

    PubMed

    McAuliffe, P; Kim, J H; Diamond, D; Lau, K T; O'Connell, B C

    2015-01-01

    It is difficult in a dental setting to accurately diagnose sleep bruxism and to objectively assess the severity, frequency or natural history of the condition in an individual patient. Yet this information is essential for the management of sleep bruxism and to plan appropriate dental treatment. The objective of this study was to clinically test a device that could be used to record bruxism events in a home environment. Pressure sensors were developed for use under the surface of an occlusal splint, and circuitry was designed to facilitate the recording and wireless transmission of the pressure sensor signal to a computer. Controlled mandibular movements were carried out in vivo to simulate bruxism and non-bruxism patterns. These patterns of force application were graphically presented to two examiners who were asked to identify the type of activity represented by the force curves. Examiners were largely able to distinguish bruxism from non-bruxism activity; the sensitivity ranged from 80% to 100% and the specificity from 75% to 100%. Using sensors in an occlusal splint, it is possible to recognise the typical tooth contact patterns seen in sleep bruxism. Such a device may be useful for monitoring sleep bruxism over an extended period at home.

  16. A digital process for additive manufacturing of occlusal splints: a clinical pilot study

    PubMed Central

    Salmi, Mika; Paloheimo, Kaija-Stiina; Tuomi, Jukka; Ingman, Tuula; Mäkitie, Antti

    2013-01-01

    The aim of this study was to develop and evaluate a digital process for manufacturing of occlusal splints. An alginate impression was taken from the upper and lower jaws of a patient with temporomandibular disorder owing to cross bite and wear of the teeth, and then digitized using a table laser scanner. The scanned model was repaired using the 3Data Expert software, and a splint was designed with the Viscam RP software. A splint was manufactured from a biocompatible liquid photopolymer by stereolithography. The system employed in the process was SLA 350. The splint was worn nightly for six months. The patient adapted to the splint well and found it comfortable to use. The splint relieved tension in the patient's bite muscles. No sign of tooth wear or significant splint wear was detected after six months of testing. Modern digital technology enables us to manufacture clinically functional occlusal splints, which might reduce costs, dental technician working time and chair-side time. Maximum-dimensional errors of approximately 1 mm were found at thin walls and sharp corners of the splint when compared with the digital model. PMID:23614943

  17. A pilot study on using eye tracking to understand assessment of surgical outcomes from clinical photography.

    PubMed

    Kim, Min Soon; Burgess, Angela; Waters, Andrew J; Reece, Gregory P; Beahm, Elisabeth K; Crosby, Melissa A; Basen-Engquist, Karen M; Markey, Mia K

    2011-10-01

    Appearance changes resulting from breast cancer treatment impact the quality of life of breast cancer survivors, but current approaches to evaluating breast characteristics are very limited. It is challenging, even for experienced plastic surgeons, to describe how different aspects of breast morphology impact overall assessment of esthetics. Moreover, it is difficult to describe what they are looking for in a manner that facilitates quantification. The goal of this study is to assess the potential of using eye-tracking technology to understand how plastic surgeons assess breast morphology by recording their gaze path while they rate physical characteristics of the breasts, e.g., symmetry, based on clinical photographs. In this study, dwell time, transition frequency, dwell sequence conditional probabilities, and dwell sequence joint probabilities were analyzed across photographic poses and three observers. Dwell-time analysis showed that all three surgeons spent the majority of their time on the anterior-posterior (AP) views. Similarly, transition frequency analysis between regions showed that there were substantially more transitions between the breast regions in the AP view, relative to the number of transitions between other views. The results of both the conditional and joint probability analyses between the breast regions showed that the highest probabilities of transitions were observed between the breast regions in the AP view (APRB, APLB) followed by the oblique views and the lateral views to complete evaluation of breast surgical outcomes.

  18. Screening for Chronic Obstructive Pulmonary Disease (COPD) in an Urban HIV Clinic: A Pilot Study

    PubMed Central

    Kaner, Robert J.; Glesby, Marshall J.

    2015-01-01

    Abstract Increased smoking and a detrimental response to tobacco smoke in the lungs of HIV/AIDS patients result in an increased risk for COPD. We aimed to determine the predictive value of a COPD screening strategy validated in the general population and to identify HIV-related factors associated with decreased lung function. Subjects at least 35 years of age at an HIV clinic in New York City completed a COPD screening questionnaire and peak flow measurement. Those with abnormal results and a random one-third of normal screens had spirometry. 235 individuals were included and 89 completed spirometry. Eleven (12%) had undiagnosed airway obstruction and 5 had COPD. A combination of a positive questionnaire and abnormal peak flow yielded a sensitivity of 20% (specificity 93%) for detection of COPD. Peak flow alone had a sensitivity of 80% (specificity 80%). Abnormal peak flow was associated with an AIDS diagnosis (p=0.04), lower nadir (p=0.001), and current CD4 counts (p=0.001). Nadir CD4 remained associated in multivariate analysis (p=0.05). Decreased FEV1 (<80% predicted) was associated with lower CD4 count nadir (p=0.04) and detectable current HIV viral load (p=0.01) in multivariate analysis. Questionnaire and peak flow together had low sensitivity, but abnormal peak flow shows potential as a screening tool for COPD in HIV/AIDS. These data suggest that lung function may be influenced by HIV-related factors. PMID:25723842

  19. The Volume Behavior of Autogenous Iliac Bone Grafts After Sinus Floor Elevation: A Clinical Pilot Study.

    PubMed

    Gerressen, Marcus; Riediger, Dieter; Hilgers, Ralf-Dieter; Hölzle, Frank; Noroozi, Nelson; Ghassemi, Alireza

    2015-06-01

    Iliac crest is still regarded as one of the most viable source of autogenous graft materials for extensive sinus floor elevation. Three-dimensional resorption behavior has to be taken into account in anticipation of the subsequent insertion of dental implants. We performed 3-dimensional volume measurements of the inserted bone transplants in 11 patients (6 women and 5 men; mean age = 2.3 years) who underwent bilateral sinus floor elevation with autogenous iliac crest grafts. In order to determine the respective bone graft volumes, cone-beam computerized tomography studies of the maxillary sinuses were carried out directly after the operation (T0), as well as 3 months (T1) and 6 months (T2) postoperatively. The acquired DICOM (Digital Imaging and Communications in Medicine) data sets were evaluated using suitable analysis software. We evaluated statistical significance of graft volumes changes using a linear mixed model with the grouping factors for time, age, side, and sex with a significance level of P = .05. 38.9% of the initial bone graft volume, which amounted to 4.2 cm(3), was resorbed until T1. At T2, the average volume again decreased significantly by 18.9 % to finally reach 1.8 cm(3). The results show neither age nor side dependency and apply equally to both sexes. Without functional load, iliac bone grafts feature low-volume stability in sinus-augmentation surgery. Further clinical and animal studies should be done to detect the optimal timing for implant placement.

  20. Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study

    PubMed Central

    Teixidor, Pilar; Vidal, Xavier; Montané, Eva

    2016-01-01

    Background During the last decade, the use of 5-aminolevulinic acid (5-ALA) has been steadily increasing in neurosurgery. The study's main objectives were to prospectively evaluate the effectiveness and safety of 5-ALA when used in clinical practice setting on high-grade gliomas’ patients. Methods National, multicenter and prospective observational study. Inclusion criteria: authorized conditions of use of 5-ALA. Exclusion criteria: contraindication to 5-ALA, inoperable or partial resected tumors, pregnancy and children. Epidemiological, clinical, laboratory, radiological, and safety data were collected. Effectiveness was assessed using complete resection of the tumor, and progression-free and overall survival probabilities. Results Between May 2010 and September 2014, 85 patients treated with 5-ALA were included, and 77 were suitable for the effectiveness analysis. Complete resection was achieved in 41 patients (54%). Surgeons considered suboptimal the fluorescence of 5-ALA in 40% of the patients assessed. The median duration of follow-up was 12.3 months. The progression-free survival probability at 6 months was 58%. The median duration overall survival was 14.2 months. Progression tumor risk factors were grade of glioma, age and resection degree; and death risk factors were grade of glioma and gender. No severe adverse effects were reported. At one month after surgery, new or increased neurological morbidity was 6.5%. Hepatic enzymes were frequently increased within the first month after surgery; however, they subsequently normalized, and this was found to have no clinical significance. Conclusion In clinical practice, the 5-ALA showed a good safety profile, but the benefits related to 5-ALA have not been yet clearly shown. The improved differentiation expected by fluorescence between normal and tumor cerebral tissue was suboptimal in a relevant number of patients; in addition, the expected higher degree of resection was lower than in clinical trials as well as

  1. A clinical research information system: an example of prospective observational study in oncology.

    PubMed

    Leskosek, Branimir L

    2008-11-06

    The paper presents a web-based clinical research information system (RIS) used by physicians and pharmacists at Institute of Oncology, Ljubljana and its geographically remote partners to collect research clinical data for observational study. The RIS development was focused mainly on: formal electronic data collection with on-line data validation, computer data preparation for uniform analyses, user friendliness, security issues, low establishment and maintenance costs.

  2. Complementary and alternative medicine use by patients visiting a free health clinic: A single-site, pilot study

    PubMed Central

    Clay, Patrick G.; Clauson, Kevin A.; Glaros, Alan

    2004-01-01

    Background: The rate of use of complementary and alternative medicine (CAM) has been documented to fluctuate widely, can greatly impact medical outcomes, and can influence patients' adherence to conventional medicines. Health care providers should assess the prevalence of CAM use (primarily herbal medicine) in individual settings to most accurately provide appropriate patient care. Objectives: The aim of this study was to determine the following: (1) differences in demographic characteristics between users and nonusers of CAM; (2) which CAM patients are using; (3) patients' sources of information concerning CAM; and (4) whether patients recall being asked about CAM use by their health care providers. Methods: In this single-center, pilot study, a self-administered survey concerning CAM use was made available to persons seeking care at an inner-city free health clinic (Kansas City Free Health Clinic, Kansas City, Missouri). Completed surveys were scanned into a database, and descriptive analyses were performed. Results: Three hundred eleven patients completed ≥1 question on the survey. Of those who reported race (n = 278), 168 (60.4%) were Caucasian/white, 73 (26.3%) were African American/black, and 24 (8.6%) were Hispanic/Latino. Of those who reported educational level (n = 287), 101 (35.2%) had some high school or were high school graduates or had a general equivalency development diploma, 102 (35.5%) had completed some college or vocational training, and 84 (29.3%) had completed college. Of those who reported personal annual income (n = 191), 107 (56.0%) reported up to US $15,000, and 54 (28.3%) reported >$15,000 to $30,000. A high rate of CAM use (past or present) was found among survey respondents (116/285 [40.7%]). No correlation was found between CAM use and any of the demographic characteristics studied. Of 98 patients reporting whether their CAM use was past or current, 64 (65.3%) were using CAM at the time of the survey. Friends and physicians were

  3. Efficacy of Selected Electrical Therapies on Chronic Low Back Pain: A Comparative Clinical Pilot Study

    PubMed Central

    Rajfur, Joanna; Pasternok, Małgorzata; Rajfur, Katarzyna; Walewicz, Karolina; Fras, Beata; Bolach, Bartosz; Dymarek, Robert; Rosinczuk, Joanna; Halski, Tomasz; Taradaj, Jakub

    2017-01-01

    Background In the currently available research publications on electrical therapy of low back pain, generally no control groups or detailed randomization were used, and such studies were often conducted with relatively small groups of patients, based solely on subjective questionnaires and pain assessment scales (lacking measurement methods to objectify the therapeutic progress). The available literature also lacks a comprehensive and large-scale clinical study. The purpose of this study was to assess the effects of treating low back pain using selected electrotherapy methods. The study assesses the influence of individual electrotherapeutic treatments on reduction of pain, improvement of the range of movement in lower section of the spine, and improvement of motor functions and mobility. Material/Methods The 127 patients qualified for the therapy (ultimately, 123 patients completed the study) and assigned to 6 comparison groups: A – conventional TENS, B – acupuncture-like TENS, C – high-voltage electrical stimulation, D – interferential current stimulation, E – diadynamic current, and F – control group. Results The research showed that using electrical stimulation with interferential current penetrating deeper into the tissues results in a significant and more efficient elimination of pain, and an improvement of functional ability of patients suffering from low back pain on the basis of an analysis of both subjective and objective parameters. The TENS currents and high voltage were helpful, but not as effective. The use of diadynamic currents appears to be useless. Conclusions Selected electrical therapies (interferential current, TENS, and high voltage) appear to be effective in treating chronic low back pain. PMID:28062862

  4. Radioguided localization of clinically occult breast lesions (ROLL): a pilot study.

    PubMed

    Medina-Franco, Heriberto; Abarca-Pérez, Leonardo; Ulloa-Gómez, José L; Romero, Cecilia

    2007-01-01

    Management of nonpalpable breast lesions requiring pathologic diagnosis has been with wire localization during the last few decades. Recently, radioguided localization (ROLL) became an alternative for this type of lesions. The objective of the present study was to evaluate the feasibility of this technique in a tertiary referral center in Mexico City. Consecutive patients requiring pathologic diagnosis from a nonpalpable breast lesion were included in the present study. On the same day of operation, all patients were injected with particles of human serum albumin. Localization of the lesion was performed in the operation theater with the aid of a hand-held gamma-probe. All lesions were identified in a control x-ray of the surgical specimen. Demographic, clinical, surgical and pathologic data were recorded. Forty patients with a mean age of 56.8 +/- 7.8 years were included. In 39 of the 40 patients (97.5%) the "hot spot" was identified easily. In all patients, the area of maximum radioactivity corresponded to the site of the lesion. Imaging confirmation of the lesion in the surgical specimen was done during the first excision in 37 patients (92.5%). In the remaining cases (7.5%), a wider excision was performed during the same procedure, finding the suspected lesion in all cases. Diagnosis of cancer was made in seven patients, (17.5%). There were no significant surgical complications. Our data suggest that ROLL offer a simple and reliable method to localize occult breast lesions, allowing complete removal of the lesion in 100% of the patients. Because of the small quantity of radioactivity, the procedure is safe for both patients and the medical staff, producing less discomfort in patients than wire localization.

  5. RS-61443--a phase I clinical trial and pilot rescue study.

    PubMed

    Sollinger, H W; Deierhoi, M H; Belzer, F O; Diethelm, A G; Kauffman, R S

    1992-02-01

    RS-61443, a morpholinoethyl ester of mycophenolic acid, inhibits the synthesis of guanosine monophosphate, which plays a pivotal role in lymphocyte metabolism. The drug blocks proliferative responses of T and B lymphocytes, and inhibits antibody formation and the generation of cytotoxic T cells. In vivo, RS-61443 prolongs the survival of islet allografts in mice, heart allografts in rats, and kidney allografts in dogs. Reversal of ongoing acute rejection was demonstrated in rat heart allografts and kidney allografts in dogs. Preliminary evidence suggests that the drug prevents chronic rejection. The purpose of this study was to test the safety and tolerance in patients receiving primary cadaver kidneys. RS-61443 in doses from 100 mg/day p.o. to 3500 mg/day p.o. was given to patients in combination with cyclosporine and prednisone. Further study goals were to evaluate the pharmacokinetics of RS-61443, watch for the occurrence of opportunistic infections and acute rejection, and establish dosages for further clinical trials. Forty-eight patients were entered, with six patients in each dose group. RS-61443 was well tolerated in all dose groups, with only one adverse event possibly related to the drug (hemorrhagic gastritis). There was a statistically significant correlation between rejection episodes and dose (P = 0.022), patients with rejection episodes versus dose (P = 0.038), and number of OKT3/prednisone courses versus dose (P = 0.008). There was no overt nephrotoxicity or hepatotoxicity. Preliminary results of a rescue trial in 20 patients with kidney transplants will also be presented.

  6. Non-Publication Is Common among Phase 1, Single-Center, Not Prospectively Registered, or Early Terminated Clinical Drug Trials

    PubMed Central

    Souverein, Patrick C.; Brekelmans, Cecile T. M.; Janssen, Susan W. J.; Koëter, Gerard H.; Leufkens, Hubert G. M.; Bouter, Lex M.

    2016-01-01

    The objective of this study was to investigate the occurrence and determinants of non-publication of clinical drug trials in the Netherlands.All clinical drug trials reviewed by the 28 Institutional Review Boards (IRBs) in the Netherlands in 2007 were followed-up from approval to publication. Candidate determinants were the sponsor, phase, applicant, centers, therapeutic effect expected, type of trial, approval status of the drug(s), drug type, participant category, oncology or other disease area, prospective registration, and early termination. The main outcome was publication as peer reviewed article. The percentage of trials that were published, crude and adjusted odds ratio (OR), and 95% confidence interval (CI) were used to quantify the associations between determinants and publication. In 2007, 622 clinical drug trials were reviewed by IRBs in the Netherlands. By the end of follow-up, 19 of these were rejected by the IRB, another 19 never started inclusion, and 10 were still running. Of the 574 trials remaining in the analysis, 334 (58%) were published as peer-reviewed article. The multivariable logistic regression model identified the following determinants with a robust, statistically significant association with publication: phase 2 (60% published; adjusted OR 2.6, 95% CI 1.1–5.9), phase 3 (73% published; adjusted OR 4.1, 95% CI 1.7–10.0), and trials not belonging to phase 1–4 (60% published; adjusted OR 3.2, 95% CI 1.5 to 6.5) compared to phase 1 trials (35% published); trials with a company or investigator as applicant (63% published) compared to trials with a Contract Research Organization (CRO) as applicant (50% published; adjusted OR 1.7; 95% CI 1.1–2.8); and multicenter trials also conducted in other EU countries (68% published; adjusted OR 2.2, 95% CI 1.1–4.4) or also outside the European Union (72% published; adjusted OR 2.0, 95% CI 1.0–4.0) compared to single-center trials (45% published). Trials that were not prospectively registered

  7. Promising approaches to circumvent the blood-brain barrier: progress, pitfalls and clinical prospects in brain cancer

    PubMed Central

    Papademetriou, Iason T; Porter, Tyrone

    2015-01-01

    Brain drug delivery is a major challenge for therapy of central nervous system (CNS) diseases. Biochemical modifications of drugs or drug nanocarriers, methods of local delivery, and blood–brain barrier (BBB) disruption with focused ultrasound and microbubbles are promising approaches which enhance transport or bypass the BBB. These approaches are discussed in the context of brain cancer as an example in CNS drug development. Targeting to receptors enabling transport across the BBB offers noninvasive delivery of small molecule and biological cancer therapeutics. Local delivery methods enable high dose delivery while avoiding systemic exposure. BBB disruption with focused ultrasound and microbubbles offers local and noninvasive treatment. Clinical trials show the prospects of these technologies and point to challenges for the future. PMID:26488496

  8. Prospective single-arm interventional pilot study to assess a smartphone-based system for measuring and supporting adherence to medication

    PubMed Central

    Pang, Yan; Wang, Zhuochun; Qiu, Boqin; Wu, Pei; Rahman-Shepherd, Afifah; Ooi, Wei Tsang; Paton, Nicholas I

    2016-01-01

    Objectives Suboptimal medication adherence for infectious diseases such as tuberculosis (TB) results in poor clinical outcomes and ongoing infectivity. Directly observed therapy (DOT) is now standard of care for TB treatment monitoring but has a number of limitations. We aimed to develop and evaluate a smartphone-based system to facilitate remotely observed therapy via transmission of videos rather than in-person observation. Design We developed an integrated smartphone and web-based system (Mobile Interactive Supervised Therapy, MIST) to provide regular medication reminders and facilitate video recording of pill ingestion at predetermined timings each day, for upload and later review by a healthcare worker. We evaluated the system in a single arm, prospective study of adherence to a dietary supplement. Healthy volunteers were recruited through an online portal. Entry criteria included age ≥21 and owning an iOS or Android-based device. Participants took a dietary supplement pill once, twice or three-times a day for 2 months. We instructed them to video each pill taking episode using the system. Outcome Adherence as measured by the smartphone system and by pill count. Results 42 eligible participants were recruited (median age 24; 86% students). Videos were classified as received—confirmed pill intake (3475, 82.7% of the 4200 videos expected), received—uncertain pill intake (16, <1%), received—fake pill intake (31, <1%), not received—technical issues (223, 5.3%) or not received—assumed non-adherence (455, 10.8%). Overall median estimated participant adherence by MIST was 90.0%, similar to that obtained by pill count (93.8%). There was a good relationship between participant adherence as measured by MIST and by pill count (Spearmans rs 0.66, p<0.001). Conclusions We have demonstrated the feasibility, acceptability and accuracy of a smartphone-based adherence support and monitoring system. The system has the potential to supplement and support the

  9. 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.

  10. 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

  11. Longitudinal changes in prospective memory and their clinical correlates at 1-year follow-up in first-episode schizophrenia

    PubMed Central

    Ungvari, Gabor S.; Ng, Chee H.; Zhou, Yan; Zhang, Liang; Zhou, Jingjing; Shum, David H. K.; Man, David; Liu, Deng-Tang; Li, Jun; Xiang, Yu-Tao

    2017-01-01

    This study aimed to investigate prospective memory (PM) and the association with clinical factors at 1-year follow-up in first-episode schizophrenia (FES). Thirty-two FES patients recruited from a university-affiliated psychiatric hospital in Beijing and 17 healthy community controls (HCs) were included. Time- and event-based PM (TBPM and EBPM) performances were measured with the Chinese version of the Cambridge Prospective Memory Test (C-CAMPROMPT) at baseline and at one-year follow-up. A number of other neurocognitive tests were also administered. Remission was determined at the endpoint according to the PANSS score ≤ 3 for selected items. Repeated measures analysis of variance revealed a significant interaction between time (baseline vs. endpoint) and group (FES vs. HCs) for EBPM (F(1, 44) = 8.8, p = 0.005) and for all neurocognitive components. Paired samples t-tests showed significant improvement in EBPM in FES (13.1±3.7 vs. 10.3±4.8; t = 3.065, p = 0.004), compared to HCs (15.7±3.6 vs. 16.5±2.3; t = -1.248, p = 0.230). A remission rate of 59.4% was found in the FES group. Analysis of covariance revealed that remitters performed significantly better on EBPM (14.9±2.6 vs. 10.4±3.6; F(1, 25) = 12.2, p = 0.002) than non-remitters at study endpoint. The association between EBPM and 12-month clinical improvement in FES suggests that EBPM may be a potential neurocognitive marker for the effectiveness of standard pharmacotherapy. Furthermore, the findings also imply that PM may not be strictly a trait-related endophenotype as indicated in previous studies. PMID:28245266

  12. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study

    PubMed Central

    Roshdy, Eman; Rajaratnam, Veera; Maitra, Sarbani; Sabry, Mohamed; Allah, Abdou S Ait; Al-Hendy, Ayman

    2013-01-01

    Background Uterine fibroids (UFs, also known as leiomyoma) affect 70% of reproductive-age women. Imposing a major burden on health-related quality-of-life (HRQL) of premenopausal women, UF is a public health concern. There are no effective medicinal treatment options currently available for women with symptomatic UF. Objectives To evaluate the efficacy and safety of green tea extract (epigallocatechin gallate [EGCG]) on UF burden and quality of life in women with symptomatic UF, in a double-blinded, placebo-controlled randomized clinical trial. Methods A total of 39 reproductive-age women (age 18–50 years, day 3 serum follicle-stimulating hormone <10 \\U/mL) with symptomatic UF were recruited for this study. All subjects had at least one fibroid lesion 2 cm3 or larger, as confirmed by transvaginal ultrasonography. The subjects were randomized to oral daily treatment with either 800 mg of green tea extract (45% EGCG) or placebo (800 mg of brown rice) for 4 months, and UF volumes were measured at the end, also by transvaginal ultrasonography. The fibroid-specific symptom severity and HRQL of these UF patients were scored at each monthly visit, using the symptom severity and quality-of-life questionnaires. Student’s t-test was used to evaluate statistical significance of treatment effect between the two groups. Results Of the final 39 women recruited for the study, 33 were compliant and completed all five visits of the study. In the placebo group (n = 11), fibroid volume increased (24.3%) over the study period; however, patients randomized to green tea extract (n = 22, 800 mg/day) treatment showed significant reduction (32.6%, P = 0.0001) in total UF volume. In addition, EGCG treatment significantly reduced fibroid-specific symptom severity (32.4%, P = 0.0001) and induced significant improvement in HRQL (18.53%, P = 0.01) compared to the placebo group. Anemia also significantly improved by 0.7 g/dL (P = 0.02) in the EGCG treatment group, while average blood loss

  13. Melatonin effects on luteinizing hormone in postmenopausal women: a pilot clinical trial NCT00288262

    PubMed Central

    Kripke, Daniel F; Kline, Lawrence E; Shadan, Farhad F; Dawson, Arthur; Poceta, J Steven; Elliott, Jeffrey A

    2006-01-01

    Background In many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes in reproductive hormones such as luteinizing hormone (LH). Melatonin's effects on human reproductive endocrinology are uncertain. It is thought that the same hypothalamic pulse generator may both trigger the pulsatile release of GnRH and LH and also cause hot flashes. Thus, if melatonin suppressed this pulse generator in postmenopausal women, it might moderate hot flashes. This clinical trial tested the hypothesis that melatonin could suppress LH and relieve hot flashes. Methods Twenty postmenopausal women troubled by hot flashes underwent one week of baseline observation followed by 4 weeks of a randomized controlled trial of melatonin or matched placebo. The three randomized treatments were melatonin 0.5 mg 2.5–3 hours before bedtime, melatonin 0.5 mg upon morning awakening, or placebo capsules. Twelve of the women were admitted to the GCRC at baseline and at the end of randomized treatment for 24-hour sampling of blood for LH. Morning urine samples were collected twice weekly to measure LH excretion. Subjective responses measured throughout baseline and treatment included sleep and hot flash logs, the CESD and QIDS depression self-ratings, and the SAFTEE physical symptom inventory. Results Urinary LH tended to increase from baseline to the end of treatment. Contrasts among the 3 randomized groups were statistically marginal, but there was relative suppression combining the groups given melatonin as contrasted to the placebo group (p < 0.01 one-tailed, Mann-Whitney U = 14.) Similar but not significant results were seen in blood LH. There were no significant contrasts among groups in hot flashes, sleep, depression, or side-effect measures and no significant adverse effects of any sort. Conclusion The data are consistent with the hypothesis that melatonin suppresses LH in postmenopausal women. An effect related to the duration of nocturnal melatonin elevation

  14. Prospective evaluation of Doppler echocardiography, tissue Doppler imaging and biomarkers measurement for the detection of doxorubicin-induced cardiotoxicity in dogs: A pilot study.

    PubMed

    Gallay-Lepoutre, J; Bélanger, M C; Nadeau, M E

    2016-04-01

    The purpose of this pilot study was to evaluate the usefulness of selected echocardiographic parameters, NT-proBNP and cardiac troponin I (cTnI) in the detection of cardiotoxicity in dogs treated with doxorubicin for various malignancies. Echocardiographic studies and biomarker measurements were performed before each administration of doxorubicin, then 1 and 3 months after completion of therapy. Thirteen dogs were included, with a total cumulative dose of doxorubicin ranging from 30 to 150 mg/m(2). E/A ratio significantly decreased during doxorubicin administration (p=0.047). cTnI level was also significantly affected by treatment (p=0.046), increasing above normal at least at one time point in 11 of 13 dogs. The results of this pilot study suggest that monitoring of left ventricular diastolic function and cTnI level measurement might be useful in the early detection of cardiotoxic signs of doxorubicin therapy in dogs.

  15. 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

  16. Increased sleep need and daytime sleepiness 6 months after traumatic brain injury: a prospective controlled clinical trial.

    PubMed

    Imbach, Lukas L; Valko, Philipp O; Li, Tongzhou; Maric, Angelina; Symeonidou, Evangelia-Regkina; Stover, John F; Bassetti, Claudio L; Mica, Ladislav; Werth, Esther; Baumann, Christian R

    2015-03-01

    Post-traumatic sleep-wake disturbances are common after acute traumatic brain injury. Increased sleep need per 24 h and excessive daytime sleepiness are among the most prevalent post-traumatic sleep disorders and impair quality of life of trauma patients. Nevertheless, the relation between traumatic brain injury and sleep outcome, but also the link between post-traumatic sleep problems and clinical measures in the acute phase after traumatic brain injury has so far not been addressed in a controlled and prospective approach. We therefore performed a prospective controlled clinical study to examine (i) sleep-wake outcome after traumatic brain injury; and (ii) to screen for clinical and laboratory predictors of poor sleep-wake outcome after acute traumatic brain injury. Forty-two of 60 included patients with first-ever traumatic brain injury were available for follow-up examinations. Six months after trauma, the average sleep need per 24 h as assessed by actigraphy was markedly increased in patients as compared to controls (8.3 ± 1.1 h versus 7.1 ± 0.8 h, P < 0.0001). Objective daytime sleepiness was found in 57% of trauma patients and 19% of healthy subjects, and the average sleep latency in patients was reduced to 8.7 ± 4.6 min (12.1 ± 4.7 min in controls, P = 0.0009). Patients, but not controls, markedly underestimated both excessive sleep need and excessive daytime sleepiness when assessed only by subjective means, emphasizing the unreliability of self-assessment of increased sleep propensity in traumatic brain injury patients. At polysomnography, slow wave sleep after traumatic brain injury was more consolidated. The most important risk factor for developing increased sleep need after traumatic brain injury was the presence of an intracranial haemorrhage. In conclusion, we provide controlled and objective evidence for a direct relation between sleep-wake disturbances and traumatic brain injury, and for clinically significant underestimation of post

  17. [Modern ultrasound methods of examination in clinical ophthalmology. Background problems and future prospects].

    PubMed

    Kharlap, S I

    2003-01-01

    Historic aspects of ultrasound diagnostics in ophthalmology are described. The technological development of ultrasound diagnostic systems and the clinical application of different ultrasound modes in examining the eye and its choroids are traced back. The efficiency of Doppler mapping in the mode of three-dimension reconstruction at examining the orbital vascular system is evaluated. An experience obtained at the Research Institute for Eye Disease of the Russian Academy of Medical Sciences and outlooks for the diagnostic usage of computer ultrasound in clinical ophthalmology and angiologia are presented.

  18. No clinical effect of back schools in an HMO. A randomized prospective trial.

    PubMed

    Berwick, D M; Budman, S; Feldstein, M

    1989-03-01

    In a prospective trial, 222 adults with low-back pain of at least 2 weeks' duration in a Health Maintenance Organization (HMO) were randomly assigned to usual care (UC), a 4-hour back school psychoeducational session (LBS), or the same back school plus a 1-year "compliance package" program designed to encourage appropriate self-management for back pain (CP). Sixty-four percent of LBS and CP subjects attended their back school sessions. Follow-up measurement of pain level (using the Visual Analogue Scale), functional status (using the Sickness Impact Profile), and various other indicators of health status showed no measurable effect of either treatment condition (LBS or CP) compared with UC at 3, 6, 12, and 18 months after entry into the study. Initial disability resolved by 3 months in most patients, and a minority of subjects (10-15%) showed residual or recurrent functional impairment 1 year after entry. Health care utilization tended to be slightly higher after intervention in the CP group. With or without follow-up encouragement, back school instructions given in a single 4-hour session had no measurable impact on the comfort or functional status of the majority of patients with new onset back pain in this HMO.

  19. 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.

  20. The effect of single incision laparoscopic cholecystectomy on systemic oxidative stress: a prospective clinical trial

    PubMed Central

    Ozturk, Bahadir; Yilmaz, Huseyin; Yormaz, Serdar; Şahin, Mustafa

    2017-01-01

    Purpose Single incision laparoscopic cholecystectomy (SILC) has become a more frequently performed method for benign gallbladder diseases all over the world. The effects of SILC technique on oxidative stress have not been well documented. The aim of this study was to evaluate the effect of laparoscopic cholecystectomy techniques on systemic oxidative stress by using ischemia modified albumin (IMA). Methods In total, 70 patients who had been diagnosed with benign gallbladder pathology were enrolled for this prospective study. Twenty-one patients underwent SILC and 49 patients underwent laparoscopic cholecystectomy (LC). All operations were performed under a standard anesthesia protocol. Serum IMA levels were analysed before operation, 45 minutes and 24 hours after operation. Results Demographics and preoperative characteristics of the patients were similiar in each group. The mean duration of operation was 37.5 ± 12.5 and 44.6 ± 14.3 minutes in LC and SILC group, respectively. In both groups, there was no statistically significant difference in hospital stay, operative time, or conversion to open surgery. Operative technique did not effect the 45th minute and 24th hour IMA levels. However, prolonged operative time (>30 minutes) caused an early increase in the level of IMA. Twenty-fourth hour IMA levels were not different. Conclusion SILC is an effective and safe surgical prosedure for benign gallbladder diseases. Independent of the surgical technique for cholecystectomy, the prolonged operative time could increase the tissue ischemia. PMID:28382289

  1. Changes of perfusion of microvascular free flaps in the head and neck: a prospective clinical study.

    PubMed

    Mücke, Thomas; Rau, Andrea; Merezas, Andreas; Kanatas, Anastasios; Mitchell, David A; Wagenpfeil, Stefan; Wolff, Klaus-Dietrich; Steiner, Timm

    2014-11-01

    Reconstruction with a free flap is routine in head and neck surgery. However, reliable assessment of perfusion can be difficult, so we prospectively evaluated it in 4 types of microvascular free flaps in the oral cavity (n=196) and assessed differences in blood flow by non-invasive monitoring with a laser Doppler flowmetry unit. We measured oxygen saturation, haemoglobin concentration, and velocity on the surface of the flap preoperatively at the donor site, and on the flap on the first, second, and seventh postoperative days, and after 4 weeks in 186/196 patients, mean (SD) age of 60 (13) years. We studied the radial forearm (n=76, 41%), fibular (n=45, 24%), anterolateral thigh (n=53, 28%), and soleus perforator (n=12, 7%) flaps. The values for the radial forearm flap differed significantly from the others. There were significant differences in haemoglobin concentrations between the fibular and soleus perforator flaps, and between the anterolateral thigh and soleus perforator flaps (p=0.002 each). Free flaps are unique in the way that perfusion develops after microvascular anastomoses. Knowledge of how each flap is perfused may indicate different patterns of healing that could potentially influence long term rehabilitation and detection of future deficits in perfusion.

  2. 77 FR 65698 - Prospective Grant of Exclusive Evaluation Option License: Pre-clinical Evaluation of Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ...: Pre- clinical Evaluation of Human Therapeutics Utilizing Ubiquitin Based Fusion Proteins With Apoptosis Modifying Proteins Such as BCL-XL AGENCY: National Institutes of Health, Public Health Service... an Extracellular BCL- x L Fusion Protein Inhibits Apoptosis'' (HHS Ref. No. E-073-...

  3. Progress and prospects of gene therapy clinical trials for the muscular dystrophies.

    PubMed

    Bengtsson, Niclas E; Seto, Jane T; Hall, John K; Chamberlain, Jeffrey S; Odom, Guy L

    2016-04-15

    Clinical trials represent a critical avenue for new treatment development, where early phases (I, I/II) are designed to test safety and effectiveness of new therapeutics or diagnostic indicators. A number of recent advances have spurred renewed optimism toward initiating clinical trials and developing refined therapies for the muscular dystrophies (MD's) and other myogenic disorders. MD's encompass a heterogeneous group of degenerative disorders often characterized by progressive muscle weakness and fragility. Many of these diseases result from mutations in genes encoding proteins of the dystrophin-glycoprotein complex (DGC). The most common and severe form among children is Duchenne muscular dystrophy, caused by mutations in the dystrophin gene, with an average life expectancy around 25 years of age. Another group of MD's referred to as the limb-girdle muscular dystrophies (LGMDs) can affect boys or girls, with different types caused by mutations in different genes. Mutation of the α-sarcoglycan gene, also a DGC component, causes LGMD2D and represents the most common form of LGMD. Early preclinical and clinical trial findings support the feasibility of gene therapy via recombinant adeno-associated viral vectors as a viable treatment approach for many MDs. In this mini-review, we present an overview of recent progress in clinical gene therapy trials of the MD's and touch upon promising preclinical advances.

  4. Prospective multicenter clinical evaluation of AMPLICOR and COBAS AMPLICOR hepatitis C virus tests.

    PubMed

    Nolte, F S; Fried, M W; Shiffman, M L; Ferreira-Gonzalez, A; Garrett, C T; Schiff, E R; Polyak, S J; Gretch, D R

    2001-11-01

    We conducted a multicenter clinical evaluation of the second versions of the manual AMPLICOR and the semiautomated COBAS AMPLICOR tests for hepatitis C virus (HCV) RNA (Roche Molecular Systems, Inc., Pleasanton, Calif.). The performance characteristics of these HCV RNA tests for diagnosis of active viral infection were determined by comparison to anti-HCV serological test results, alanine aminotransferase levels, and liver biopsy histology results. A total of 878 patients with clinical or biochemical evidence of liver disease were enrolled at four hepatology clinics. A total of 1,089 specimens (901 serum and 188 plasma) were tested with the AMPLICOR test. Sensitivity compared to serology was 93.1% for serum and 90.6% for plasma. The specificity was 97% for serum and 93.1% for plasma. A total of 1,084 specimens (896 serum and 188 plasma) were tested with the COBAS test. Sensitivities for serum and plasma were the same as with the AMPLICOR test. The specificity was 97.8% for serum and 96.6% for plasma. Of the 69 specimens with false-positive and false-negative AMPLICOR test results relative to those of serology, alternative primer set (APS) reverse transcription (RT)-PCR analysis showed that the AMPLICOR test provided the correct result relative to the specimens containing HCV RNA in 64 (92.7%) specimens. Similarly, 66 of 67 (98.5%) false-positive and false-negative COBAS test results were determined to be correct by APS RT-PCR analysis. There were no substantive differences in clinical performances between study sites, patient groups, specimen types, storage conditions (-20 to -80 degrees C versus 2 to 8 degrees C), or anticoagulants (EDTA versus acid citrate dextrose) for either test. Both tests showed >99% reproducibility within runs, within sites, and overall. We conclude that these tests can reliably detect the presence of HCV RNA, as evidence of active infection, in patients with clinical or biochemical evidence of liver disease.

  5. 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.

  6. Symptoms and Clinical Course of EHEC O104 Infection in Hospitalized Patients: A Prospective Single Center Study

    PubMed Central

    Neumann-Grutzeck, Christine; Otto, Helge; Rüther, Christoph; von Seydewitz, Cay Uwe; Meyer, Gerd Peter; Ahmadi-Simab, Keihan; Röther, Joachim; Hogan, Barbara; Schwenk, Wolfgang; Fischbach, Roman; Caselitz, Jörg; Puttfarcken, Jochen; Huggett, Susanne; Tiedeken, Petra; Pober, Jordan; Kirkiles-Smith, Nancy C.; Hagenmüller, Friedrich

    2013-01-01

    Objectives Shiga-toxin producing O157:H7 Entero Haemorrhagic E. coli (STEC/EHEC) is one of the most common causes of Haemolytic Uraemic Syndrome (HUS) related to infectious haemorrhagic colitis. Nearly all recommendations on clinical management of EHEC infections refer to this strain. The 2011 outbreak in Northern Europe was the first to be caused by the serotype O104:H4. This EHEC strain was found to carry genetic features of Entero Aggregative E. coli (EAEC) and extended spectrum β lactamase (ESBL). We report symptoms and complications in patients at one of the most affected centres of the 2011 EHEC O104 outbreak in Northern Germany. Methods The courses of patients admitted to our hospital due to bloody diarrhoea with suspected EHEC O104 infection were recorded prospectively. These data include the patients’ histories, clinical findings, and complications. Results EHEC O104 infection was confirmed in 61 patients (female = 37; mean age: 44±2 years). The frequency of HUS was 59% (36/61) in our cohort. An enteric colonisation with co-pathogens was found in 57%. Thirty-one (51%) patients were treated with plasma-separation/plasmapheresis, 16 (26%) with haemodialysis, and 7 (11%) with Eculizumab. Patients receiving antibiotic treatment (n = 37; 61%) experienced no apparent change in their clinical course. Twenty-six (43%) patients suffered from neurological symptoms. One 83-year-old patient died due to comorbidities after HUS was successfully treated. Conclusions EHEC O104:H4 infections differ markedly from earlier reports on O157:H7 induced enterocolitis in regard to epidemiology, symptomatology, and frequency of complications. We recommend a standard of practice for clinical monitoring and support the renaming of EHEC O104:H4 syndrome as “EAHEC disease”. PMID:23460784

  7. Assessing the clinical value of targeted massively parallel sequencing in a longitudinal, prospective population-based study of cancer patients

    PubMed Central

    Wong, S Q; Fellowes, A; Doig, K; Ellul, J; Bosma, T J; Irwin, D; Vedururu, R; Tan, A Y-C; Weiss, J; Chan, K S; Lucas, M; Thomas, D M; Dobrovic, A; Parisot, J P; Fox, S B

    2015-01-01

    Introduction: Recent discoveries in cancer research have revealed a plethora of clinically actionable mutations that provide therapeutic, prognostic and predictive benefit to patients. The feasibility of screening mutations as part of the routine clinical care of patients remains relatively unexplored as the demonstration of massively parallel sequencing (MPS) of tumours in the general population is required to assess its value towards the health-care system. Methods: Cancer 2015 study is a large-scale, prospective, multisite cohort of newly diagnosed cancer patients from Victoria, Australia with 1094 patients recruited. MPS was performed using the Illumina TruSeq Amplicon Cancer Panel. Results: Overall, 854 patients were successfully sequenced for 48 common cancer genes. Accurate determination of clinically relevant mutations was possible including in less characterised cancer types; however, technical limitations including formalin-induced sequencing artefacts were uncovered. Applying strict filtering criteria, clinically relevant mutations were identified in 63% of patients, with 26% of patients displaying a mutation with therapeutic implications. A subset of patients was validated for canonical mutations using the Agena Bioscience MassARRAY system with 100% concordance. Whereas the prevalence of mutations was consistent with other institutionally based series for some tumour streams (breast carcinoma and colorectal adenocarcinoma), others were different (lung adenocarcinoma and head and neck squamous cell carcinoma), which has significant implications for health economic modelling of particular targeted agents. Actionable mutations in tumours not usually thought to harbour such genetic changes were also identified. Conclusions: Reliable delivery of a diagnostic assay able to screen for a range of actionable mutations in this cohort was achieved, opening unexpected avenues for investigation and treatment of cancer patients. PMID:25742471

  8. Prospective evaluation of epidemiological, clinical, and microbiological features of pandemic influenza A (H1N1) virus infection in Italy.

    PubMed

    Fabbiani, Massimiliano; Sali, Michela; Di Cristo, Valentina; Pignataro, Giulia; Prete, Valentina; Farina, Salvatore; D'Avino, Alessandro; Manzara, Stefania; Dal Verme, Lorenzo Zileri; Silveri, Nicolò Gentiloni; Cauda, Roberto; Delogu, Giovanni; Fadda, Giovanni; Di Giambenedetto, Simona

    2011-12-01

    Since several characteristics of pandemic influenza A (H1N1) virus infection remain to be determined, this study aimed to describe clinical features and complications of patients infected with H1N1. Subjects affected by influenza-like illnesses and a control group of asymptomatic patients were enrolled prospectively at an Emergency Department from October 2009 to April 2010. At enrollment, clinical data and nasopharyngeal swabs for virological analyses were obtained. Ill subjects were followed until recovery and swabs were collected weekly in patients infected with H1N1. Of 318 patients enrolled, 92 (28.9%) were positive to H1N1. Patients infected with H1N1 were mainly young adults and complained classic influenza-like symptoms. Fever was observed for a median time of 5 (IQR 3-7) days. Hospitalization occurred in 27.7% with 2% requiring intensive care unit admission: median length of hospitalization was 6 days (IQR 5-9). Pneumonia was diagnosed in 19.6% of patients. A similar proportion of lower airways involvement and of clinical complications was observed in subjects testing positive or negative for H1N1. However, patients infected with H1N1 were younger and hospitalized for a shorter period as compared to the control group (P = 0.002 and P = 0.045, respectively). Older age, asthma/chronic obstructive pulmonary disease and hypertension were associated with an increased risk of pneumonia. Viral shedding was observed for at least 1 week in 21.3% of patients. Asymptomatic infection was uncommon (1.1%). Respiratory syndromes caused by H1N1 and factors associated with disease severity were investigated and compared to influenza-like illnesses of other origin. Such findings might contribute to improve clinical and epidemiological management of the disease.

  9. Clinical characteristics of patients with community-acquired complicated intra-abdominal infections: a prospective, multicentre, observational study.

    PubMed

    Jean, Shio-Shin; Ko, Wen-Chien; Xie, Yang; Pawar, Vaishali; Zhang, Dongmu; Prajapati, Girish; Mendoza, Myrna; Kiratisin, Pattarachai; Ramalheira, Elmano; Castro, Ana Paula; Rosso, Fernando; Hsueh, Po-Ren

    2014-09-01

    In this prospective, observational, multicentre study using data from five countries (Columbia, The Philippines, Portugal, Taiwan and Thailand), the clinical impact of extended-spectrum β-lactamase (ESBL)-producing organisms on hospitalised patients with community-acquired complicated intra-abdominal infections (CA-cIAIs) was compared with that of non-ESBL-producing organisms during the period April 2010 to December 2011. Adult patients (aged ≥18 years) requiring surgery or percutaneous drainage were enrolled and were followed during the first hospitalisation course. An unadjusted statistical comparison of risk factors for ESBL-positive and ESBL-negative patients was performed. Multivariate regression analyses were performed to assess whether length of stay (LOS) in hospital, clinical cure rate and some important clinical characteristics were associated with ESBL positivity. During the study period, a total of 105 adult patients from five countries were enrolled, of whom 17 (16.2%) had CA-cIAI due to ESBL-positive organisms and 88 (83.8%) had CA-cIAI due to ESBL-negative organisms. Escherichia coli was isolated in 73.3% of all samples. Infections were cured in 8 (47.1%) of the patients with CA-cIAI due to ESBL-positive organisms and in 59 (67.0%) of the patients with CA-cIAI due to ESBL-negative organisms (P=0.285). The median LOS was 11.6 days for patients with infections due to ESBL-negative organisms and 17.6 days for patients with infections due to ESBL-positive organisms (P=0.011). Multivariate logistic regression analysis revealed that pre-existing co-morbidities, but not ESBL positivity, were adversely associated with clinical cure of CA-cIAIs. In contrast, duration of hospitalisation was longer for patients with CA-cIAI due to ESBL-positive organisms.

  10. Five-year prospective clinical study of posterior three-unit zirconia-based fixed dental prostheses.

    PubMed

    Sorrentino, Roberto; De Simone, Giorgio; Tetè, Stefano; Russo, Simona; Zarone, Fernando

    2012-06-01

    This prospective clinical trial aimed at evaluating the clinical performance of three-unit posterior zirconia fixed dental prostheses (FDPs) after 5 years of clinical function. Thirty-seven patients received 48 three-unit zirconia-based FDPs. The restorations replaced either a premolar or a molar. Specific inclusion criteria were needed. Tooth preparation was standardized. Computer-aided design/computer-assisted manufacturing frameworks with a 9-mm(2) cross section of the connector and a 0.6-mm minimum thickness of the retainer were made. The restorations were luted with resin cement. The patients were recalled after 1, 6, 12, 24, 36, 48, and 60 months. The survival and success of the ceramics and zirconia were evaluated. The technical and aesthetic outcomes were examined using the United States Public Health Service criteria. The biologic outcomes were analyzed at abutment and contralateral teeth. Descriptive statistics were performed. All FDPs completed the study, resulting in 100% cumulative survival rate and 91.9% and 95.4% cumulative success rates for patients wearing one and two FDPs, respectively. No losses of retention were recorded. Forty-two restorations were rated alpha in all measured parameters. A minor chipping of the ceramics was detected in three restorations. No significant differences between the periodontal parameters of the test and control teeth were observed. Five-year clinical results proved that three-unit posterior zirconia-based FDPs were successful in the medium term for both function and aesthetic. Zirconia can be considered a promising substitute of metal frameworks for the fabrication of short-span posterior prostheses.

  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. 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.

  13. The cognitive profile of prion disease: a prospective clinical and imaging study

    PubMed Central

    Caine, Diana; Tinelli, Renata J; Hyare, Harpreet; De Vita, Enrico; Lowe, Jessica; Lukic, Ana; Thompson, Andrew; Porter, Marie-Claire; Cipolotti, Lisa; Rudge, Peter; Collinge, John; Mead, Simon

    2015-01-01

    Objectives Prion diseases are dementing illnesses with poorly defined neuropsychological features. This is probably because the most common form, sporadic Creutzfeldt-Jakob disease, is often rapidly progressive with pervasive cognitive decline making detailed neuropsychological investigation difficult. This study, which includes patients with inherited, acquired (iatrogenic and variant) and sporadic forms of the disease, is the only large-scale neuropsychological investigation of this patient group ever undertaken and aimed to define a neuropsychological profile of human prion diseases. Methods A tailored short cognitive examination of all of the patients (n = 81), with detailed neuropsychological testing in a subset with mild disease (n = 30) and correlation with demographic, clinical, genetic (PRNP mutation and polymorphic codon 129 genotype), and other variables (MRI brain signal change in cortex, basal ganglia or thalamus; quantitative research imaging, cerebrospinal fluid 14-3-3 protein). Results Comparison with healthy controls showed patients to be impaired on all tasks. Principal components analysis showed a major axis of fronto-parietal dysfunction that accounted for approximately half of the variance observed. This correlated strongly with volume reduction in frontal and parietal gray matter on MRI. Examination of individual patients' performances confirmed early impairment on this axis, suggesting characteristic cognitive features in mild disease: prominent executive impairment, parietal dysfunction, a largely expressive dysphasia, with reduced motor speed. Interpretation Taken together with typical neurological features, these results complete a profile that should improve differential diagnosis in a clinical setting. We propose a tailored neuropsychological battery for early recognition of clinical onset of symptoms with potential for use in clinical trials involving at-risk individuals. PMID:26000326

  14. Clinical Space Medicine A Prospective Look at Medical Problems From Hazards of Space Operations

    DTIC Science & Technology

    1967-07-01

    percent CO2 have immediately experienced one or more of a number of clinical manifestations, such as extreme dyspnea, visual and auditory hallucinations ... hearing loss. It has been reported that at about a 200 mm Hg negative pressure 96 differential, the tympanic membrane may disrupt (1) However this...of hearing loss of up to 15 to 30 decibels can persist from a few hours to many days in duration, depending mainly on such factors as the degree of

  15. Comparison of anchorage loss following initial leveling and aligning using ROTH and MBT Prescription – A clinical prospective study

    PubMed Central

    Rajesh, M; Kishore, MSV; Shetty, K Sadashiva

    2014-01-01

    Background: To evaluate the amount and percentage of anchor loss after initial leveling and aligning using a ROTH and MBT prescription. Materials & Methods: Pre and post alignment lateral cephalograms & dental casts of 10 ROTH & 10 MBT patients. Results: In the study, it was found that the amount of anchor loss is greater in the ROTH group than the MBT group. This could be due to the increased anterior tip in the ROTH prescription, compared to MBT. The total anterior tip in ROTH is 270 and in MBT is 200. The additional tip of 70 in ROTH prescription itself would have resulted in forward thrust of the anteriors. Conclusion: The use of laceback and cinchbacks creates a statistically and clinically significant increase in the anchorage loss specifically when the posterior anchorage is not enhanced. In this study TPA was not used but studies have shown that passive TPA has almost no effect on the clinician's need to preserve anchorage in the correction of malocclusion. On the other hand, the TPA is an excellent way to prevent molar rotation and maintain the original vertical and transverse dimension when desired. How to cite the article: Rajesh M, Kishore MS, Shetty KS. Comparison of anchorage loss following initial leveling and aligning using ROTH and MBT Prescription – A clinical prospective study. J Int Oral Health 2014;6(2):16-21. PMID:24876697

  16. The clinical significance of Cyniclomyces guttulatus in dogs with chronic diarrhoea, a survey and a prospective treatment study.

    PubMed

    Mandigers, Paul J J; Duijvestijn, Mirjam B H M; Ankringa, Nynke; Maes, Sofie; van Essen, Elise; Schoormans, Anky H W; German, Alexander J; Houwers, Dirk J

    2014-08-06

    This study surveyed the prevalence of massive numbers of Cyniclomyces guttulatus in faecal samples from healthy dogs (18%) and dogs with chronic diarrhoea (14%) suggesting that this yeast has no clinical significance. Subsequently, a total of 57 referred dogs with chronic diarrhoea were selected because they excreted massive numbers of C. guttulatus and their initial diagnostic work-up yielded no other direct clues explaining their diarrhoea. Treatment with nystatin did not result in any clinical response in 36 out of these 57 dogs (63%), although they no longer shed the yeast. However, a response was noted in the remaining 21 (37%) dogs: 13 were 'responders', in that their diarrhoea subsided for more than two weeks and the faeces were cleared of the yeast. However, three of these dogs relapsed repeatedly, with signs of diarrhoea and massive shedding of the yeast. The other eight dogs were 'incomplete responders', whereby faecal quality initially normalised, but diarrhoea relapsed within two weeks, whilst still not shedding the yeast. In these cases, further diagnostic work up revealed other co-causes of diarrhoea. It was concluded that there was no direct evidence that C. guttulatus is a primary pathogen. However, the results of the prospective treatment study suggest that a possible role in a minority of cases, perhaps as an opportunist, cannot be ruled out.

  17. Online assessment of ALS functional rating scale compares well to in-clinic evaluation: A prospective trial

    PubMed Central

    Maier, André; Holm, Teresa; Wicks, Paul; Steinfurth, Laura; Linke, Peter; Münch, Christoph; Meyer, Robert; Meyer, Thomas

    2012-01-01

    Self-assessment of symptom progression in chronic diseases is of increasing importance in clinical research, patient management and specialized outpatient care. Against this background, we developed a secure internet platform (ALShome.de) that allows online assessment of the revised ALS Functional Rating Scale (ALSFRS-R) and other established self-assessment questionnaires. We developed a secure and closed internet portal to assess patient reported outcomes. In a prospective, controlled and stratified study, patients conducted a web-based self-assessment of ALSFRS-R compared to on-site assessment. On-site and online assessments were compared at baseline (n = 127) and after 3.5 months (n = 81, 64%). Results showed that correlation between on-site evaluation and online testing of ALSFRS-R was highly significant (r = 0.96; p < 0.001). The agreement of both capturing methods (online vs. on-site) was excellent (mean interval, 8.8 days). The adherence to online rating was high; 75% of patients tested on-site completed a follow-up online visit (mean 3.5 months, SD 1.7). We conclude that online self-assessment of ALS severity complements the well-established face-to-face application of the ALSFRS-R during on-site visits. The results of our study support the use of online administration of ALSFRS-R within clinical trials and for managing the care of ALS patients. PMID:22292842

  18. 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

  19. Comparative outcomes of the two types of sacral extradural spinal meningeal cysts using different operation methods: a prospective clinical study.

    PubMed

    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.

  20. 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

  1. Comparison of organochlorine chemical body burdens of female breast cancer cases with cancer free women in Rio Grande do Sul, Brazil--Pilot Study

    SciTech Connect

    Erdmann, C.A.; Petreas, M.X.; Caleffi, M.; Barbosa, F.S.; Goth-Goldstein, R.

    1999-12-01

    This pilot study collected preliminary data to examine known and suspected breast cancer risk factors among women living in rural and urban areas in the state of Rio Grande do Sul, Brazil by questionnaire. In addition, the body burden levels of a panel of organochlorines was measured in a small clinic-based prospective sample.

  2. Clinical Prediction of Suicide and Undetermined Death: A Pseudo-Prospective Clinical and Medico-Legal Study of Substance Abusers

    PubMed Central

    Brådvik, Louise; Berglund, Mats; Frank, Arne; Löwenhielm, Peter

    2017-01-01

    This study examines aspects of prediction of suicide and death of undetermined intent. We investigated all consecutive, autopsied patients between 1993 and 1997 who had been in contact with the Addiction Centre in Malmö from 1968 onwards. The staff was asked, shortly after autopsy but before they knew of the manner of death, if they thought the patient had committed suicide. The case records were blindly evaluated, and toxicological autopsy findings for alcohol in blood samples investigated. The specificity of prediction was 83% and significantly more often correct than the sensitivity, which was only 45% for suicide and for suicide/death of undetermined intent (93% versus 39%). Suicidal communication was more often considered non-serious before death of undetermined intent than before suicide. The former could be predicted by ideation but not by suicide attempt reported in case records, unlike suicide, which was predicted by both. The undetermined group also showed higher levels of alcohol in the blood at autopsy. We concluded that more serious clinical investigation of suicidal feelings, which may be hidden and not taken seriously, and treatment of alcohol use disorders with active follow-up appear urgent in the efforts to prevent suicide. PMID:28304357

  3. 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.

  4. Comparison of Acute and Chronic Pain after Open Nephrectomy versus Laparoscopic Nephrectomy: A Prospective Clinical Trial.

    PubMed

    Alper, Isik; Yüksel, Esra

    2016-04-01

    We evaluated postoperative pain intensity and the incidence of chronic pain in patients with renal cell carcinoma undergoing laparoscopic or open radical nephrectomy. In this prospective study, 27 laparoscopic nephrectomy (Group LN) and 25 open nephrectomy (Group ON) patients were included. All patients received paracetamol infusion and intramuscular morphine 30 minutes before the end of the operation and intravenous patient controlled analgesia with morphine postoperatively. Data including patients' demographics, visual analog scale (VAS) pain scores at postoperative 0.5, 1, 2, 4, 6, 12, and 24 hours, postoperative morphine consumption, analgesic demand, analgesic delivery, number of patients requiring rescue analgesics, side effects because of analgesic medications, and overall patient satisfaction were recorded and compared between the two groups. Two and 6 months after the operation, patients were evaluated for chronic postsurgical pain (CPSP). Postoperative average VAS pain scores were not different between the two groups. However, only at 2 hours postoperatively, pain score was significantly higher in Group ON than in Group LN. In both groups, the highest pain scores were recorded at 30 minutes and 1 hour after surgery. Ninety-six percent of group ON patients and 88% of group LN patients required additional analgesia in the early postoperative period (P = 0.33). Postoperative morphine consumption and analgesic demand were found to be similar between the two groups. CPSP at 2 months after surgery was observed in 4 out of 25 patients (16%) in the ON group and 3 out of 27 patients (11.1%) in the LN group (P = 0.6). Chronic pain at 6 months after surgery was observed in 1 ON patient (4%) and 1 LN patient (3.7%, P = 0.9). This study demonstrated that postoperative acute pain scores were not different after laparoscopic or open nephrectomy and patients undergoing laparoscopic or open nephrectomy were at equal risk of developing CPSP. Pain control

  5. Prospective clinical trial of hepatitis B vaccination in adults with and without type-2 diabetes mellitus

    PubMed Central

    Van Der Meeren, Olivier; Peterson, James T.; Dionne, Marc; Beasley, Richard; Ebeling, Peter R.; Ferguson, Murdo; Nissen, Michael D.; Rheault, Paul; Simpson, Richard W.; De Ridder, Marc; Crasta, Priya D.; Miller, Jacqueline M.; Trofa, Andrew F.

    2016-01-01

    ABSTRACT  Objective: Patients with diabetes mellitus are at increased risk for hepatitis B virus (HBV) infection and its complications. HBV vaccination is recommended for adults with diabetes in the United States and other countries. However, few studies have assessed safety and immunogenicity of hepatitis B vaccine in such patients. We assessed the safety and immunogenicity of recombinant hepatitis B vaccine in subjects with and without diabetes mellitus. Methods: Prospective, multi-country controlled study in 21 centers (www.clinicaltrials.gov NCT01627340). Four hundred and sixteen participants with Type-2 diabetes and 258 controls matched for age and body mass index (BMI) (2:1 ratio) received 3-doses of HBV vaccine (Engerix-B™, GSK Vaccines, Belgium) according to a 0, 1, 6 months schedule. Antibodies were measured against HBV surface antigen and expressed as seroprotection rates (anti-HBs ≥10mIU/mL) and geometric mean concentration (GMC). Results: The median age and BMI in patients with diabetes and controls (according-to-protocol cohort) were 54 y and 32.1 kg/m2, and 53 y and 30.8 kg/m2, respectively. Seroprotection rates (GMCs) one month post-dose-3 were 75.4% (147.6 mIU/mL) and 82.0% (384.2 mIU/mL) in patients with diabetes and controls, respectively. Age-stratified seroprotection rates for patients with diabetes were 88.5% (20–39 years), 81.2% (40–49 years), 83.2% (50–59 years), and 58.2% (≥60 years). The overall safety profile of hepatitis B vaccine was similar between groups. Conclusions: Hepatitis B vaccine is immunogenic in patients with diabetes and has a similar safety profile to vaccination in healthy controls. Because increasing age was generally associated with a reduction in seroprotection rates, hepatitis B vaccine should be administered as soon as possible after the diagnosis of diabetes. PMID:27123743

  6. A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders

    PubMed Central

    Geier, David A.; Kern, Janet K.; Davis, Georgia; King, Paul G.; Adams, James B.; Young, John L.; Geier, Mark R.

    2011-01-01

    Summary Background L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted. Material/Methods Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing. Results Significant improvements were observed in CARS (−2.03, 95% CI=−3.7 to −0.31), CGI (−0.69, 95% CI=−1.1 to −0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given. Conclusions L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended. PMID:21629200

  7. 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.

  8. 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.

  9. Clinical and neuropsychological features of violence in schizophrenia: A prospective cohort study.

    PubMed

    Bulgari, Viola; Iozzino, Laura; Ferrari, Clarissa; Picchioni, Marco; Candini, Valentina; De Francesco, Alessandra; Maggi, Paolo; Segalini, Beatrice; de Girolamo, Giovanni

    2017-03-01

    The increased risk of violence in schizophrenia has been linked to several environmental, clinical and neuropsychological factors, including executive dysfunction. However, data about the nature of these effects are mixed and controversial. The main aim of this study was to investigate the relationship between clinical and neuropsychological factors with violence risk in patients with schizophrenia, taking into account current psychopathology and lifetime alcohol use. We compared a sample of patients living in Residential Facilities (RFs) with schizophrenia and a past history of interpersonal violence (vSZ, N=50) to patients with schizophrenia matched on age, gender and alcohol abuse/dependence but with no violence history (nvSZ, N=37). We then established the association between the clinical and neuropsychological factors that predicted violence over a 1year follow-up period. The results revealed that vSZ patients living in RFs were characterized by greater compulsory hospital admissions, higher anger and less negative symptoms as compared to nvSZ patients. vSZ patients performed better on executive and motor tasks than nvSZ; however, these differences appeared to be explained by the lower negative psychotic symptom in the vSZ group. Both groups were involved in episodes of violence during the follow-up period; among the two, the vSZ patients were more likely to be violent. Negative symptoms predicted less verbal aggression at 1year follow-up. Overall, these findings support a key role of negative rather than positive symptoms in driving violence risk among SZ patients living in RFs, in a manner that negative symptoms are linked to a lower risk of violence.

  10. Vertebral pain in helicopter pilots

    NASA Technical Reports Server (NTRS)

    Auffret, R.; Delahaye, R. P.; Metges, P. J.; VICENS

    1980-01-01

    Pathological forms of spinal pain engendered by piloting helicopters were clinically studied. Lumbalgia and pathology of the dorsal and cervical spine are discussed along with their clinical and radiological signs and origins.

  11. Frailty Markers and Treatment Decisions in Patients Seen in Oncogeriatric Clinics: Results from the ASRO Pilot Study

    PubMed Central

    de Decker, Laure; Pauly, Vanessa; Rousseau, Frédérique; Bergman, Howard; Molines, Catherine

    2016-01-01

    Background Comprehensive Geriatric Assessment (CGA) is the gold standard to help oncologists select the best cancer treatment for their older patients. Some authors have suggested that the concept of frailty could be a more useful approach in this population. We investigated whether frailty markers are associated with treatment recommendations in an oncogeriatric clinic. Methods This prospective study included 70 years and older patients with solid tumors and referred for an oncogeriatric assessment. The CGA included nine domains: autonomy, comorbidities, medication, cognition, nutrition, mood, neurosensory deficits, falls, and social status. Five frailty markers were assessed (nutrition, physical activity, energy, mobility, and strength). Patients were categorized as Frail (three or more frailty markers), pre-frail (one or two frailty markers), or not-frail (no frailty marker). Treatment recommendations were classified into two categories: standard treatment with and without any changes and supportive/palliative care. Multiple logistic regression models were used to analyze factors associated with treatment recommendations. Results 217 patients, mean age 83 years (± Standard deviation (SD) 5.3), were included. In the univariate analysis, number of frailty markers, grip strength, physical activity, mobility, nutrition, energy, autonomy, depression, Eastern Cooperative Oncology Group Scale of Performance Status (ECOG-PS), and falls were significantly associated with final treatment recommendations. In the multivariate analysis, the number of frailty markers and basic Activities of Daily Living (ADL) were significantly associated with final treatment recommendations (p<0.001 and p = 0.010, respectively). Conclusion Frailty markers are associated with final treatment recommendations in older cancer patients. Longitudinal studies are warranted to better determine their use in a geriatric oncology setting. PMID:26918947

  12. Prospect of Human Pluripotent Stem Cell-Derived Neural Crest Stem Cells in Clinical Application

    PubMed Central

    Zhu, Qian; Lu, Qiqi; Gao, Rong

    2016-01-01

    Neural crest stem cells (NCSCs) represent a transient and multipotent cell population that contributes to numerous anatomical structures such as peripheral nervous system, teeth, and cornea. NCSC maldevelopment is related to various human diseases including pigmentation abnormalities, disorders affecting autonomic nervous system, and malformations of teeth, eyes, and hearts. As human pluripotent stem cells including human embryonic stem cells (hESCs) and human induced pluripotent stem cells (hiPSCs) can serve as an unlimited cell source to generate NCSCs, hESC/hiPSC-derived NCSCs can be a valuable tool to study the underlying mechanisms of NCSC-associated diseases, which paves the way for future therapies for these abnormalities. In addition, hESC/hiPSC-derived NCSCs with the capability of differentiating to various cell types are highly promising for clinical organ repair and regeneration. In this review, we first discuss NCSC generation methods from human pluripotent stem cells and differentiation mechanism of NCSCs. Then we focus on the clinical application potential of hESC/hiPSC-derived NCSCs on peripheral nerve injuries, corneal blindness, tooth regeneration, pathological melanogenesis, Hirschsprung disease, and cardiac repair and regeneration. PMID:28090209

  13. Assessing clinical prospects of silicon quantum dots: studies in mice and monkeys.

    PubMed

    Liu, Jianwei; Erogbogbo, Folarin; Yong, Ken-Tye; Ye, Ling; Liu, Jing; Hu, Rui; Chen, Hongyan; Hu, Yazhuo; Yang, Yi; Yang, Jinghui; Roy, Indrajit; Karker, Nicholas A; Swihart, Mark T; Prasad, Paras N

    2013-08-27

    Silicon nanocrystals can provide the outstanding imaging capabilities of toxic heavy-metal-based quantum dots without employing heavy metals and have potential for rapid progression to the clinic. Understanding the toxicity of silicon quantum dots (SiQDs) is essential to realizing this potential. However, existing studies of SiQD biocompatibility are limited, with no systematic progression from small-animal to large-animal studies that are more clinically relevant. Here, we test the response of both mice and monkeys to high intravenous doses of a nanoconstruct created using only SiQDs and FDA-approved materials. We show that (1) neither mice nor monkeys show overt signs of toxicity reflected in their behavior, body mass, or blood chemistry, even at a dose of 200 mg/kg. (2) This formulation did not biodegrade as expected. Elevated levels of silicon were present in the liver and spleen of mice three months post-treatment. (3) Histopathology three months after treatment showed adverse effects of the nanoformulation in the livers of mice, but showed no such effects in monkeys. This investigation reveals that the systemic reactions of the two animal models may have some differences and there are no signs of toxicity clearly attributable to silicon quantum dots.

  14. Reproductive options for prospective parents in families with Huntington's disease: clinical, psychological and ethical reflections.

    PubMed

    de Die-Smulders, C E M; de Wert, G M W R; Liebaers, I; Tibben, A; Evers-Kiebooms, G

    2013-01-01

    BACKGROUND Huntington's disease (HD) is an autosomal dominant neurodegenerative late onset disorder. This review of reproductive options aims to increase reproductive confidence and to prevent suffering in relation to family planning around HD and possibly other late onset neurodegenerative disorders. METHODS Selected relevant literature and own views and experiences as clinical geneticists, psychologists and ethicists have been used. RESULTS Possible options, with emphasis on prenatal diagnosis (PD) and preimplantation genetic diagnosis (PGD) to prevent the transmission of HD to the next generation, are described and discussed. They are formally presented in a decision tree, taking into account the presence or absence of a fully penetrant allele (FPA), a reduced penetrant allele (RPA) or an intermediate allele (IA). A table compares invasive and non-invasive PD and PGD. From a psychological perspective, the complex process of counselling and decision-making regarding reproductive options is discussed. Special attention is paid to the decision to avoid the transmission of the mutation and to the confrontation and coping of a mutation-free child growing up with a parent developing disease symptoms. From an ethical point of view, reflections on both PD and PGD are brought forward taking into account the difference between FPA, RPA and IA, direct testing or exclusion testing and taking into account the welfare of the child in the context of medically assisted reproduction. CONCLUSION Recommendations and suggestions for good clinical practice in the reproductive care for HD families are formulated.

  15. 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.

  16. 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

  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. Gene therapy for liver regeneration: Experimental studies and prospects for clinical trials

    PubMed Central

    Atta, Hussein M

    2010-01-01

    The liver is an exceptional organ, not only because of its unique anatomical and physiological characteristics, but also because of its unlimited regenerative capacity. Unfolding of the molecular mechanisms that govern liver regeneration has allowed researchers to exploit them to augment liver regeneration. Dramatic progress in the field, however, was made by the introduction of the powerful tool of gene therapy. Transfer of genetic materials, such as hepatocyte growth factor, using both viral and non-viral vectors has proved to be successful in augmenting liver regeneration in various animal models. For future clinical studies, ongoing research aims at eliminating toxicity of viral vectors and increasing transduction efficiency of non-viral vectors, which are the main drawbacks of these systems. Another goal of current research is to develop gene therapy that targets specific liver cells using receptors that are unique to and highly expressed by different liver cell types. The outcome of such investigations will, undoubtedly, pave the way for future successful clinical trials. PMID:20731015

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

    PubMed

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

    2015-07-01

    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.

  20. Perfusion and diffusion MRI of glioblastoma progression in a four-year prospective temozolomide clinical trial

    SciTech Connect

    Leimgruber, Antoine; Ostermann, Sandrine; Yeon, Eun Jo; Buff, Evelyn; Maeder, Philippe P.; Stupp, Roger; Meuli, Reto A. . E-mail: Reto.Meuli@chuv.ch

    2006-03-01

    Purpose: This study was performed to determine the impact of perfusion and diffusion magnetic resonance imaging (MRI) sequences on patients during treatment of newly diagnosed glioblastoma. Special emphasis has been given to these imaging technologies as tools to potentially anticipate disease progression, as progression-free survival is frequently used as a surrogate endpoint. Methods and Materials: Forty-one patients from a phase II temolozomide clinical trial were included. During follow-up, images were integrated 21 to 28 days after radiochemotherapy and every 2 months thereafter. Assessment of scans included measurement of size of lesion on T1 contrast-enhanced, T2, diffusion, and perfusion images, as well as mass effect. Classical criteria on tumor size variation and clinical parameters were used to set disease progression date. Results: A total of 311 MRI examinations were reviewed. At disease progression (32 patients), a multivariate Cox regression determined 2 significant survival parameters: T1 largest diameter (p < 0.02) and T2 size variation (p < 0.05), whereas perfusion and diffusion were not significant. Conclusion: Perfusion and diffusion techniques cannot be used to anticipate tumor progression. Decision making at disease progression is critical, and classical T1 and T2 imaging remain the gold standard. Specifically, a T1 contrast enhancement over 3 cm in largest diameter together with an increased T2 hypersignal is a marker of inferior prognosis.

  1. 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

  2. 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

  3. Clinical Characteristics and Outcomes of Hospitalized Older Patients with Distinct Risk Profiles for Functional Decline: A Prospective Cohort Study

    PubMed Central

    Buurman, Bianca M.; Hoogerduijn, Jita G.; van Gemert, Elisabeth A.; de Haan, Rob J.; Schuurmans, Marieke J.; de Rooij, Sophia E.

    2012-01-01

    Background The aim of this research was to study the clinical characteristics and mortality and disability outcomes of patients who present distinct risk profiles for functional decline at admission. Methods Multicenter, prospective cohort study conducted between 2006 and 2009 in three hospitals in the Netherlands in consecutive patients of ≥65 years, acutely admitted and hospitalized for at least 48 hours. Nineteen geriatric conditions were assessed at hospital admission, and mortality and functional decline were assessed until twelve months after admission. Patients were divided into risk categories for functional decline (low, intermediate or high risk) according to the Identification of Seniors at Risk-Hospitalized Patients. Results A total of 639 patients were included, with a mean age of 78 years. Overall, 27%, 33% and 40% of the patients were at low, intermediate or high risk, respectively, for functional decline. Low-risk patients had fewer geriatric conditions (mean 2.2 [standard deviation [SD] 1.3]) compared with those at intermediate (mean 3.8 [SD 2.1]) or high risk (mean 5.1 [SD 1.8]) (p<0.001). Twelve months after admission, 39% of the low-risk group had an adverse outcome, compared with 50% in the intermediate risk group and 69% in the high risk group (p<0.001). Conclusion By using a simple risk assessment instrument at hospital admission, patients at low, intermediate or high risk for functional decline could be identified, with distinct clinical characteristics and outcomes. This approach should be tested in clinical practice and research and might help appropriately tailor patient care. PMID:22238628

  4. A prospective, randomized clinical trial of antiretroviral therapies on carotid wall thickness: AIDS Clinical Trial Group Study A5260s

    PubMed Central

    Stein, James H.; Ribaudo, Heather J.; Hodis, Howard N.; Brown, Todd T.; Tran, Thuy Tien T.; Yan, Mingzhu; Brodell, Elizabeth Lauer; Kelesidis, Theodore; McComsey, Grace A.; Dube, Michael P.; Murphy, Robert L.; Currier, Judith S.

    2015-01-01

    Objective This article compares the effects of initiating three contemporary antiretroviral therapy (ART) regimens on progression of carotid artery intima-media thickness (IMT) over 3 years. Design Randomized clinical trial. Setting Multicenter (26 institutions). Patients ART-naïve HIV-infected individuals (n = 328) without known cardiovascular disease or diabetes mellitus. Intervention Random assignment to tenofovir/emtricitabine along with atazanavir/ritonavir (ATV/r), darunavir/ritonavir (DRV/r), or raltegravir (RAL). Main outcome measures Right-sided carotid IMT was evaluated by B-mode ultra-sonography before ART initiation, and then after 48, 96, and 144 weeks. Comparisons of yearly rates of change in carotid IMT used mixed-effects linear regression models that permitted not only evaluation of the effects of ART on carotid IMT progression but also how ART-associated changes in traditional risk factors, bilirubin, and markers of HIV infection were associated carotid IMT progression. Results HIV-1 RNA suppression rates were high in all arms (>85%) over 144 weeks. Modest increases in triglycerides and non-high-density lipoprotein cholesterol levels were observed in the protease inhibitor containing arms compared with decreases with RAL. In contrast, carotid IMT progressed more slowly on ATV/r [8.2, 95% confidence interval (5.6, 10.8) μm/year] than DRV/r [12.9 (10.3, 15.5) μm/year, P = 0.013]; changes with RAL were intermediate [10.7 (9.2, 12.2) μm/year, P = 0.15 vs. ATV/r; P = 0.31 vs. DRV/r]. Bilirubin and non-high-density lipoprotein cholesterol levels appeared to influence carotid IMT progression rates. Conclusion In ART-naïve HIV-infected individuals at low cardiovascular disease risk, carotid IMT progressed more slowly in participants initiating ATV/r than those initiating DRV/r, with intermediate changes associated with RAL. This effect may be due, in part, to hyperbilirubinemia. PMID:26372383

  5. Inflation and deflation timing of the AutoCAT 2 WAVE intra-aortic balloon pump using the autoPilot mode in a clinical setting.

    PubMed

    Bakker, E W M; Visser, K; van der Wal, A; Kuiper, M A; Koopmans, M; Breedveld, R

    2012-09-01

    The primary goal of this observational clinical study was to register the occurrence of incorrect inflation and deflation timing of an intra-aortic balloon pump in autoPilot mode. The secondary goal was to identify possible causes of incorrect timing. During IABP assistance of 60 patients, every four hours a strip was printed with the IABP frequency set to 1:2. Strips were examined for timing discrepancies beyond 40 ms from the dicrotic notch (inflation) and the end of the diastolic phase (deflation). In this way, 320 printed strips were examined. A total of 52 strips (16%) showed incorrect timing. On 24 of these strips, the incorrect timing was called incidental, as it showed on only one or a few beats. The other 28 cases of erroneous timing were called consistent, as more than 50% of the beats on the strip showed incorrect timing. We observed arrhythmia in 69% of all cases of incorrect timing. When timing was correct, arrhythmia was found on 13 (5%) of 268 strips. A poor quality electrocardiograph (ECG) signal showed on 37% of all strips with incorrect timing and 11% of all strips with proper timing. We conclude that inflation and deflation timing of the IABP is not always correct when using the autoPilot mode. The quality of the ECG input signal and the occurrence of arrhythmia appear to be related to erroneous timing. Switching from autoPilot mode to operator mode may not always prevent incorrect timing.

  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. Effectiveness of 2 scavenger mask systems for reducing exposure to nitrous oxide in a hospital-based pediatric dental clinic: a pilot study.

    PubMed

    Freilich, Marshall M; Alexander, Laura; Sándor, George K B; Judd, Peter

    2007-09-01

    Chronic exposure to elevated ambient air levels of nitrous oxide during nitrous oxide/ oxygen (N2O/2) sedation can result in deleterious side effects to dentists and auxiliary staff. A sampling survey was done in the outpatient dental clinic at the Hospital for Sick Children to determine whether airborne nitrous oxide (N2O) gas concentrations were within established regulatory limits. The effectiveness of 2 scavenger mask systems, the Matrix Medical single-mask system and the Porter/Brown double-mask system, for reducing airborne contamination in a clinical environment during the treatment of pediatric dental patients was compared in a pilot study. The results indicated that the double-mask system more effectively minimized N2O exposure during N2O/O2 sedation of outpatients for a variety of clinical pediatric dental procedures.

  8. Ethical issues in and beyond prospective clinical trials of human gene therapy.

    PubMed

    Fletcher, J C

    1985-08-01

    As the potential for the first human trials of somatic cell gene therapy nears, two ethical issues are examined: problems of moral choice for members of institutional review boards who consider the first protocols, for parents, and for the clinical researchers, and the special protections that may be required for the infants and children to be involved, and ethical objections to somatic cell therapy made by those concerned about a putative inevitable progression of genetic knowledge from therapy to mass genetic engineering in human reproduction. The author's viewpoint is that a consensus exists on the required moral approach to somatic cell therapy, but that no moral approach yet exists for experiments beyond this level, especially in the germline cells of human beings.

  9. 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

  10. Clinical Course and Genetic Susceptibility of Primary Biliary Cirrhosis: Analysis of a Prospective Cohort

    PubMed Central

    Almasio, Piero Luigi; Licata, Anna; Maida, Marcello; Macaluso, Fabio Salvatore; Costantino, Andrea; Alessi, Nicola; Grimaudo, Stefania; Accardi, Giulia; Caruso, Calogero; Craxi, Antonio

    2016-01-01

    Background Natural history of primary biliary cirrhosis (PBC) is partially characterized in patients from the Mediterranean area whose genetic background differs from that of Northern Europeans. Objectives We aimed to describe genetic susceptibility and clinical course of PBC in patients from Southern Italy. Methods Socio-demographic, clinical, biochemical and histological data at diagnosis as well as disease progression of 81 PBC consecutive patients were collected. All subjects were treated with Ursodeoxycholic acid at a dose of 15 mg/kg. HLA class II DRB1 alleles were compared with those of 237 healthy control subjects. IL28B genotyping for IL28B rs12979860 C/T and rs80899917 G/T was performed in a sub-group of patients. Results HLA-DRB1*07 (RR 5.3, P = 0.0008) and HLA-DRB1*08 (RR n.c. P = 0.0005) were significantly associated with the risk of PBC development. Patients younger than 45 years had significantly higher alanine aminotransferase (P = 0.038) and alkaline phosphatase levels (P = 0.047) than older cases. In comparison to non-CC rs12979860, patients with CC rs12979860 genotype showed an early histological stage at onset (93.8% vs. 62.5%, P = 0.03). After a mean follow-up of 61 months, three patients died, one underwent liver transplantation and sixteen (21.9%) had progression of the disease. At multivariate analysis, extrahepatic autoimmune disease (P = 0.04), pruritus (P = 0.008) and advanced histological stage (P < 0.0001) were independent risk factors for disease progression. Conclusions HLA-DRB1*07 and HLA-DRB1*08 alleles increase susceptibility to disease development. At onset, higher biochemical activity was observed in younger patients, whereas rs12979860 CC genotype was associated with milder histological stage. Pruritus and coexistence of extrahepatic autoimmune diseases were significantly associated with poorer prognosis. PMID:28070198

  11. Prospective evaluation of a new automated nucleic acid extraction system using routine clinical respiratory specimens.

    PubMed

    Mengelle, C; Mansuy, J-M; Sandres-Sauné, K; Barthe, C; Boineau, J; Izopet, J

    2012-06-01

    The aim of the study was to evaluate the MagNA Pure 96™ nucleic acid extraction system using clinical respiratory specimens for identifying viruses by qualitative real-time PCR assays. Three extraction methods were tested, that is, the MagNA Pure LC™, the COBAS Ampliprep™, and the MagNA Pure 96™ with 10-fold dilutions of an influenza A(H1N1)pdm09 sample. Two hundred thirty-nine respiratory specimens, 35 throat swabs, 164 nasopharyngeal specimens, and 40 broncho-alveolar fluids, were extracted with the MagNA Pure 96™ and the COBAS Ampliprep™ instruments. Forty COBAS Ampliprep™ positive samples were also tested. Real-time PCRs were used to identify influenza A and influenza A(H1N1)pdm09, rhinovirus, enterovirus, adenovirus, varicella zoster virus, cytomegalovirus, and herpes simplex virus. Similar results were obtained on RNA extracted from dilutions of influenza A(H1N1)pdm09 with the three systems: the MagNA Pure LC™, the COBAS Ampliprep™, and the MagNA Pure 96™. Data from clinical respiratory specimens extracted with the MagNA Pure 96™ and COBAS Ampliprep™ instruments were in 98.5% in agreement (P < 0.0001) for influenza A and influenza A(H1N1)pdm09. Data for rhinovirus were in 97.3% agreement (P < 0.0001) and in 96.8% agreement for enterovirus. They were in 100% agreement for adenovirus. Data for cytomegalovirus and HSV1-2 were in 95.2% agreement (P < 0.0001). The MagNA Pure 96™ instrument is easy-to-use, reliable, and has a high throughput for extracting total nucleic acid from respiratory specimens. These extracts are suitable for molecular diagnosis with any type of real-time PCR assay.

  12. Genomic Array as Compared to Karyotyping in Myelodysplastic Syndromes in a Prospective Clinical trial.

    PubMed

    Stevens-Kroef, Marian J; Olde Weghuis, Daniel; ElIdrissi-Zaynoun, Najat; van der Reijden, Bert; Cremers, Eline M P; Alhan, Canan; Westers, Theresia M; Visser-Wisselaar, Heleen A; Chitu, Dana A; Cunha, Sonia M; Vellenga, Edo; Klein, Saskia K; Wijermans, Pierre; de Greef, Georgine E; Schaafsma, M R; Muus, Petra; Ossenkoppele, Gert J; van de Loosdrecht, Arjan A; Jansen, Joop H

    2017-02-25

    Karyotyping is considered as the gold standard in the genetic subclassification of myelodysplastic syndrome (MDS). Oligo/SNP-based genomic array profiling is a high-resolution tool that also enables genome wide analysis. We compared karyotyping with oligo/SNP-based array profiling in 104 MDS patients from the HOVON-89 study. Oligo/SNP-array identified all cytogenetically defined genomic lesions, except for subclones in two cases and balanced translocations in three cases. On the other hand oligo/SNP-based genomic array profiling had a higher success rate, showing 55 abnormal cases, while an abnormal karyotype was found in only 35 patients. In 9 patients whose karyotyping was unsuccessful because of insufficient metaphases or failure, oligo/SNP-based array analysis was successful. Based on cytogenetic visible abnormalities as identified by oligo/SNP-based genomic array prognostic scores based on IPSS/-R were assigned. These prognostic scores were identical to the IPSS/-R scores as obtained with karyotyping in 95-96% of the patients. In addition to the detection of cytogenetically defined lesions, oligo/SNP-based genomic profiling identified focal copy number abnormalities or regions of copy neutral loss of heterozygosity that were out of the scope of karyotyping and fluorescence in situ hybridization. Of interest, in 26 patients we demonstrated such cytogenetic invisible abnormalities. These abnormalities often involved regions that are recurrently affected in hematological malignancies, and may therefore be of clinical relevance. Our findings indicate that oligo/SNP-based genomic array can be used to identify the vast majority of recurrent cytogenetic abnormalities in MDS. Furthermore, oligo/SNP-based array profiling yields additional genetic abnormalities that may be of clinical importance. This article is protected by copyright. All rights reserved.

  13. Treatment outcomes in patients with internet addiction: a clinical pilot study on the effects of a cognitive-behavioral therapy program.

    PubMed

    Wölfling, K; Beutel, M E; Dreier, M; Müller, K W

    2014-01-01

    Internet addiction is regarded as a growing health concern in many parts of the world with prevalence rates of 1-2% in Europe and up to 7% in some Asian countries. Clinical research has demonstrated that Internet addiction is accompanied with loss of interests, decreased psychosocial functioning, social retreat, and heightened psychosocial distress. Specialized treatment programs are needed to face this problem that has recently been added to the appendix of the DSM-5. While there are numerous studies assessing clinical characteristics of patients with Internet addiction, the knowledge about the effectiveness of treatment programs is limited. Although a recent meta-analysis indicates that those programs show effects, more clinical studies are needed here. To add knowledge, we conducted a pilot study on the effects of a standardized cognitive-behavioral therapy program for IA. 42 male adults meeting criteria for Internet addiction were enrolled. Their IA-status, psychopathological symptoms, and perceived self-efficacy expectancy were assessed before and after the treatment. The results show that 70.3% of the patients finished the therapy regularly. After treatment symptoms of IA had decreased significantly. Psychopathological symptoms were reduced as well as associated psychosocial problems. The results of this pilot study emphasize findings from the only meta-analysis conducted so far.

  14. The impact of an interprofessional problem-based learning curriculum of clinical ethics on medical and nursing students' attitudes and ability of interprofessional collaboration: a pilot study.

    PubMed

    Lin, Yu-Chih; Chan, Te-Fu; Lai, Chung-Sheng; Chin, Chi-Chun; Chou, Fan-Hao; Lin, Hui-Ju

    2013-09-01

    Clinical ethic situations in modern multiprofessional healthcare systems may involve different healthcare professions who work together for patient care. The undergraduate interprofessional education of clinical ethics would help to incubate healthcare students' ability of interprofessional collaboration in solving ethical problems. However, the impact from an interprofessional educational model on student's attitudes and confidence of interprofessional collaboration should be carefully evaluated during the process of curricular development. This study aimed to conduct a pilot interprofessional PBL curriculum of clinical ethics and evaluate the curricular impact on interprofessional students' attitude and confidence of collaborative teamwork. Thirty-six medical and nursing students volunteered to participate in this study and were divided into three groups (medical group, nursing group, and mixed group). Tutors were recruited from the Medical School and the College of Nursing. The pilot curriculum included one lecture of clinical ethics, one PBL case study with two tutorial sessions, and one session of group discussion and feedback. A narrative story with multiple story lines and a multiperspective problem analysis tool were used in the PBL tutorials. The students' self-evaluation of learning questionnaire was used to evaluate students' learning of clinical ethics and interprofessional collaborative skills and attitude. The internal consistency of the questionnaire was measured by Cronbach α, and the criterion-related validity of the questionnaire was evaluated through associations between the dimension scores with the student group by one-way analysis of variance test (ANOVA) test and Tukey-Kramer honestly significant difference (HSD) comparison. There was significant difference among different groups in students' ability and attitudes about "interprofessional communication and collaboration" (p = 0.0184). The scores in the mixed group (37.58 ± 3.26) were higher

  15. 77 FR 59911 - Request To Make Special Program for the Law School Clinic Certification Patent Pilot Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... accordance with standard examination procedures. III. Requirement for Restriction If the claims in the... out of turn (accorded special status) for examination. Each school participating in the patent pilot... normally taken up for examination in the order of their United States filing date. See section 708 of...

  16. Safety and effectiveness of teriparatide vs alendronate in postmenopausal osteoporosis: a prospective non randomized clinical study.

    PubMed

    Caggiari, Gianfilippo; Leali, Paolo Tranquilli; Mosele, Giulia Raffaella; Puddu, Leonardo; Badessi, Francesca; Doria, Carlo

    2016-01-01

    In this work we study the safety and effectiveness of teriparatide and alendronate in patients with postmenopausal osteoporosis at high risk of fracture; it was a double-blinded and it was done by examining the comparisons between teriparatide 20 μg/day and alendronate 10 mg/day. Safety and effectiveness analyses were based on data from 355 woman with a mean age of 68 years. Two groups (A and B) with T-score ≤-2.5 at bone mineral density were analyzed and 3 or more vertebral fractures on radiograph. Group A: was treated with teriparatide 20 μg/day and composed from 182 women, in post-menopausal age, without a history of cancer. Group B: was treated with alendronate 10 mg/day composed from 173 women, postmenopausal age, with previous history of cancer (non-active during the study). Clinical evaluations were on bone turnover markers (alkaline phosphatase, procollagene type 1 N-terminal propeptide, and N-telopeptide cross-links), dual-energy X-ray absorptiometry and health-related quality of life (HrQoL). Safety was assessed by reporting of adverse drug reactions (ADRs). The results of this study imply that teriparatide comparated with alendronate has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture.

  17. Concise review: clinical prospects for treating chronic obstructive pulmonary disease with regenerative approaches.

    PubMed

    Kubo, Hiroshi

    2012-08-01

    Chronic obstructive pulmonary disease (COPD) is becoming a major cause of death worldwide. COPD is characterized by a progressive and not fully reversible airflow limitation caused by chronic small airway disease and lung parenchymal destruction. Clinically available drugs improve airflow obstruction and respiratory symptoms but cannot cure the disease. Slowing the progressive lung destruction or rebuilding the destroyed lung structure is a promising strategy to cure COPD. In contrast to small animal models, pharmacological lung regeneration is difficult in human COPD. Maturation, aging, and senescence in COPD lung cells, including endogenous stem cells, may affect the regenerative capacity following pharmacological therapy. The lung is a complex organ composed of more than 40 different cell types; therefore, detailed analyses, such as epigenetic modification analysis, in each specific cell type have not been performed in lungs with COPD. Recently, a method for the direct isolation of individual cell types from human lung has been developed, and fingerprints of each cell type in COPD lungs can be analyzed. Research using this technique combined with the recently discovered lung endogenous stem-progenitor populations will give a better understanding about the fate of COPD lung cells and provide a future for cell-based therapy to treat this intractable disease.

  18. Bacteraemia in Intensive Care Unit: Clinical, Bacteriological, and Prognostic Prospective Study

    PubMed Central

    Lachhab, Zineb; Kasouati, Jalal; Doghmi, Nouafal; Ben Lahlou, Yassine; Lemnouer, Abdelhay; Elouennass, Mostafa

    2017-01-01

    Objectives. We conducted a one-year observational study from December 2012 to November 2013 to describe the epidemiology of bacteraemia in intensive care units (ICU) of Mohammed V Military Teaching Hospital of Rabat (Morocco). Methods. The study consisted of monitoring all blood cultures coming from intensive care units and studying the bacteriological profile of positive blood cultures as well as their clinical significance. Results. During this period, a total of 46 episodes of bacteraemia occurred, which corresponds to a rate of 15,4/1000 patients. The rate of nosocomial infections was 97% versus 3% for community infections. The most common source of bacteraemia was the lungs in 33%, but no source was identified in 52% of the episodes. Gram negative organisms were isolated in 83,6% of the cases with Acinetobacter baumannii being the most frequent. Antibiotic resistance was very high with 42,5% of extended-spectrum beta-lactamases (ESBLs) in Enterobacteriaceae and 100% of carbapenemase in Acinetobacter baumannii. The antibiotherapy introduced in the first 24 hours was adequate in 72% of the cases. Conclusions. Bloodstream infections in ICU occur most often in patients over 55 years, with hypertension and diabetes. The bacteria involved are mainly Gram negative bacteria multiresistant to antibiotics. Early administration of antibiotics significantly reduces patients mortality.

  19. 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

  20. Safety and effectiveness of teriparatide vs alendronate in postmenopausal osteoporosis: a prospective non randomized clinical study

    PubMed Central

    Caggiari, Gianfilippo; Leali, Paolo Tranquilli; Mosele, Giulia Raffaella; Puddu, Leonardo; Badessi, Francesca; Doria, Carlo

    2016-01-01

    Summary In this work we study the safety and effectiveness of teriparatide and alendronate in patients with postmenopausal osteoporosis at high risk of fracture; it was a double-blinded and it was done by examining the comparisons between teriparatide 20 μg/day and alendronate 10 mg/day. Safety and effectiveness analyses were based on data from 355 woman with a mean age of 68 years. Two groups (A and B) with T-score ≤–2.5 at bone mineral density were analyzed and 3 or more vertebral fractures on radiograph. Group A: was treated with teriparatide 20 μg/day and composed from 182 women, in post-menopausal age, without a history of cancer. Group B: was treated with alendronate 10 mg/day composed from 173 women, postmenopausal age, with previous history of cancer (non-active during the study). Clinical evaluations were on bone turnover markers (alkaline phosphatase, procollagene type 1 N-terminal propeptide, and N-telopeptide cross-links), dual-energy X-ray absorptiometry and health-related quality of life (HrQoL). Safety was assessed by reporting of adverse drug reactions (ADRs). The results of this study imply that teriparatide comparated with alendronate has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture. PMID:28228782

  1. A prospective study of group cohesiveness in therapeutic horticulture for clinical depression.

    PubMed

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

    2011-04-01

    This study aimed to assess changes in psychological distress and social participation in adults diagnosed with clinical depression during and after participating in a therapeutic horticulture programme, and to investigate if the changes covaried with levels of group cohesiveness during the intervention. An intervention with a single-group design was repeated with different samples in successive years (pooled n = 46). In each year, five groups of 3-7 participants went through the intervention. Data were collected before, twice during, and immediately after a 12-week therapeutic horticulture programme, as well as at 3-months' follow up. Mental health assessments included the Beck Depression Inventory, the State Subscale of Spielberger State-Trait Anxiety Inventory, the Positive Affect Scale from the Positive and Negative Affect Scale, the Perceived Stress Scale, and the Therapeutic Factors Inventory-Cohesiveness Scale. The analysis of the pooled data confirmed significant beneficial change in all mental health variables during the intervention. Change from baseline in depression severity persisted at 3-months' follow up. Increased social activity after the intervention was reported for 38% of the participants. The groups quickly established strong cohesiveness, and this continued to increase during the intervention. The average level of group cohesiveness correlated positively, but not significantly, with change in all mental health outcome variables.

  2. [Fabry disease: clinic and enzymatic diagnosis of homozygous and heterozygous. New therapeutic prospects].

    PubMed

    Peces, R; Olea, T

    2002-01-01

    Fabry disease is an X-linked recessive lysosomal storage disorder caused by a partial or complete deficiency of alpha-galactosidase A. Intracellular accumulation of globotriaosylceramide, the glycolipid substrate of this enzyme, leads to severe painful neuropathy with progressive renal, cardiovascular, and cerebrovascular dysfunction and early death. Men are predominantly affected but many female carriers have similar clinical involvement, including increased risk of stroke. Physical stigmata, such as angiokeratomas in skin and mucous membranes and characteristic benign corneal abnormalities, facilitate identification of Fabry disease. The finding of a marked decreased activity of (alpha-galactosidase A in plasma, white blood cells or cultured skin fibroblasts confirms the diagnosis. Treatment thus far has been symptomatic only. Etiology-based therapies are being developed that include enzyme replacement therapy, gene therapy, and substrate deprivation. The recently completed double-blind, placebo-controlled trials of intravenous infusions of (alpha-galactosidase A in patients with Fabry disease demonstrated the safety and efficacy of this treatment. We report a family with Fabry disease composed of hemicygous and heterocygous. The propositus developed chronic renal failure and received a cadaver renal transplant, which remained with adequate renal function during 15 years.

  3. The administration of intermittent parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: a protocol for a prospective mixed method pilot study with randomisation of treatment allocation and blinded assessment (FRACTT)

    PubMed Central

    Chesser, Tim; Fox, Rebecca; Harding, Karen; Greenwood, Rosemary; Javaid, Kassim; Barnfield, Steven; Halliday, Ruth; Willett, Keith; Lamb, Sallie

    2014-01-01

    Introduction Pertrochanteric hip fractures occur in an elderly population and cause considerable morbidity and loss of functional ability as the fracture heals. Recently, parathyroid hormone (PTH), which is licensed for the treatment of osteoporosis, has been shown to potentially accelerate bone healing in animal and human studies. If its administration could allow a faster functional recovery after pertrochanteric hip fracture, then a patient's hospital stay may be reduced and rehabilitation could be potentially accelerated. PTH can currently only be administered by subcutaneous injection. The acceptability of this intervention is unknown in this elderly population. The aim of this pilot study is to inform the design of a future powered study comparing the functional recovery after pertrochanteric hip fracture in patients undergoing standard care versus those who undergo administration of subcutaneous injection of PTH. Methods and analysis The study is an open label, prospective, randomised, comparative pilot study with blinded outcomes assessment to establish feasibility of the trial design. Patients will be randomised to receive a 6-week course of PTH or usual treatment. Functional outcomes will be assessed at 6 weeks and 12 weeks. Blinded assessment will be used to minimise the effect of bias of an open label study design. A nested qualitative study will investigate the patient experience of, and expectations following, hip fracture and the patient important aspects of recovery compared with the outcome measures proposed. Results Results will be analysed to establish the potential recruitment, compliance and retention rates using 95% CIs, and trial outcomes quoted with SDs and 95% CIs for the effect size. Ethics and dissemination The study has been approved by the South West 2 Research Ethics committee (reference 10/H0206/34). The findings of this study will be disseminated to the medical community via presentations to orthopaedic, orthogeriatric and

  4. The effect of a monocular helmet-mounted display on aircrew health: a 10-year prospective cohort study of Apache AH MK 1 pilots: study midpoint update

    NASA Astrophysics Data System (ADS)

    Hiatt, Keith L.; Rash, Clarence E.; Watters, Raymond W.; Adams, Mark S.

    2009-05-01

    A collaborative occupational health study has been undertaken by Headquarters Army Aviation, Middle Wallop, UK, and the U.S. Army Aeromedical Research Laboratory, Fort Rucker, Alabama, to determine if the use of the Integrated Helmet and Display Sighting System (IHADSS) monocular helmet-mounted display (HMD) in the Apache AH Mk 1 attack helicopter has any long-term (10-year) effect on visual performance. The test methodology consists primarily of a detailed questionnaire and an annual battery of vision tests selected to capture changes in visual performance of Apache aviators over their flight career (with an emphasis on binocular visual function). Pilots using binocular night vision goggles serve as controls and undergo the same methodology. Currently, at the midpoint of the study, with the exception of a possible colour discrimination effect, there are no data indicating that the long-term use of the IHADSS monocular HMD results in negative effects on vision.

  5. Clinical significance of pyloric aperture in the aetiology of peptic ulcer disease: a prospective study.

    PubMed

    Saha, Sisir Kumar

    2009-04-01

    Despite so much contributions reported in the literature, the aetiology of the duodenal ulcer remains an enigmatic subject to the medical profession. Findings of Helicobacter pylori seem to have overshadowed the real issue, in that, how a small area of the duodenal mucosa could be inflicted with the acid-pepsin injury has not been questioned? One hundred and sixty-eight consecutive patients, presented with epigastric pain were included in the endoscopic study. The aim of the study was to find out the prevalence and its clinical importance on the sizes of the pyloric aperture in the aetiology of peptic ulcer disease. Demographic data on the sizes of the pyloric aperture were divided into two groups, in that, those up to 3 mm in diameter were included in one and those over the size of 3 mm in another. Among the 168 cases, the gastric ulcer was found in 12 and duodenal ulcer in 27 patients. The sex ratio of men to women was 1.4:1 found in the former and 8:1 in the latter. Among other findings, a knuckle of duodenal mucoa was noticed prolapsing through the large pyloric aperture. It could be postulated that a knuckle of the mucosa that keeps peeping through the pylorus acts as a mucosal plug in empty stomach, like a cork in the acid bottle. The main physiological function is to protect the mucosa from being damaged by the acid-pepsin injury or by the reflux of bile, but the tip of the plug seems to be subjected to such injury. Furthermore, the surface epithelial cells could also be subjected to ischaemic change while prolapsing through the pylorus. This may lead to reduced production of the mucosal gel and bicarbonate secretion, thus exposing the damaged mucosa to acid bath. This supports the concept, how a small area of the stomach or duodenum could be inflicted with ulceration.

  6. 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

  7. A prospective study of the pathophysiology and clinical characteristics of pain in a palliative medicine population.

    PubMed

    Gutgsell, Terence; Walsh, Declan; Zhukovsky, Donna S; Gonzales, Francisco; Lagman, Ruth

    2003-01-01

    Comprehensive pain evaluation is requisite for optimal management. Few studies have evaluated pain syndromes and adequacy of associated analgesic regimens in one population. Available studies in cancer populations have focused on ambulatory patients or hospice-type inpatients. This study was designed to evaluate multiple characteristics of pain and adequacy of therapy in a broad spectrum of patients with advanced cancer presenting to a palliative medicine service. One hundred pain patients (95 with cancer) underwent a comprehensive pain evaluation consisting of history, physical examination, review of available diagnostics, and a pain assessment tool designed for routine clinical use. Seventy-one percent of 141 evaluable patients reported pain in the month before referral. In these 100 patients, 158 distinct sites of pain were reported, with 88 percent reporting a maximum of 2. Pain due to tumor was the most common cause (68 percent), and the most common pathophysiologic mechanism, somatic (52 percent). Pain was almost equally divided between continuous (48 percent) and intermittent (52 percent). Breakthrough pain occurred in 75 percent of continuous pains. Of these, 30 percent were exclusively incidental, 26percent nonincidental, and 16 percent due to end-of-dose failure. The remainder was of mixed etiology, but almost always with an incidental component. Of intermittent pain syndromes, 61 percent were incidental. On referral, analgesic dosing was inadequate and was compounded by use of regimens that typically did not meet peer-reviewed guidelines. Comprehensive studies rigorously evaluating characteristics of pain and response to treatment are a necessary first step toward more effective treatments for difficult pain syndromes.

  8. 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

  9. Incidence of neurosensory deficits and recovery after lower third molar surgery: a prospective clinical study of 4338 cases.

    PubMed

    Cheung, L K; Leung, Y Y; Chow, L K; Wong, M C M; Chan, E K K; Fok, Y H

    2010-04-01

    A prospective study of all lower third molar surgery performed in the outpatient extraction clinic of a teaching dental hospital was conducted from January 1998 through October 2005 to determine the incidence of subsequent neurosensory deficit due to inferior alveolar nerve (IAN) and lingual nerve (LN) injury, to examine possible contributing risk factors and to describe the pattern of recovery. 3595 patients were included (61% female, 39% male; age range, 14-82 years). Of the 4338 lower third molar extractions performed by various grades of operators, 0.35% developed IAN deficit and 0.69% developed LN deficit. Distoangular impaction was found to increase the risk of LN deficit significantly (p<0.001). Depth of impaction was related to the risk of IAN deficit (p<0.001). Undergraduates caused more LN deficits (p<0.001). Sex, age, raising of a lingual flap, protection of LN with a retractor, removal of distolingual cortex, tooth sectioning and difficulty in tooth elevation were not significantly related to IAN or LN injury. Postoperative recovery from IAN and LN deficits was noted most significantly at 3 and 6 months, respectively. By the end of the follow-up period, 67% of IAN deficits and 72% of LN deficits had recovered completely.

  10. 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

  11. Prospective double-blind clinical trial evaluating the effectiveness of Bromelain in the third molar extraction postoperative period

    PubMed Central

    de la Barrera-Núñez, María C.; Yáñez-Vico, Rosa M.; Batista-Cruzado, Antonio; Heurtebise-Saavedra, Jean M.; Castillo-de Oyagüe, Raquel

    2014-01-01

    Objectives: To evaluate the anti-inflammatory and analgesic effect of Bromelain (pineapple extract) administered orally in the postoperative after extraction of impacted lower molars. Study Design: This is a prospective, placebo-controlled, unicentric, double-blind study; the sample size was 34 patients. The pre and postoperative outcomes, evaluated on the third (D3) and eighth day (D8), included inflamtion, pain and oral aperture, as well as the need for analgesics. One group received bromelain 150mg per day for three days and 100mg on days 4 to 7. The other group received placebo in the same dosage. All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for independent samples. Results: Although there were no statistically significant differences between the treatment groups, a trend towards less inflammation and improved oral aperture was observed in the group that received bromelain, compared to the group that received placebo. This trend can be attributed completely to random reasons, since there is no statistical difference in the results. Conclusions: Further studies are necessary to analyze different administration patterns and doses of bromelain for the use in the postoperative of impacted third molars. Key words:Tooth extraction, third molar, postoperative period, bromeline, clinical study. PMID:24316697

  12. 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.

  13. Evidence in Practice – A Pilot Study Leveraging Companion Animal and Equine Health Data from Primary Care Veterinary Clinics in New Zealand

    PubMed Central

    Muellner, Petra; Muellner, Ulrich; Gates, M. Carolyn; Pearce, Trish; Ahlstrom, Christina; O’Neill, Dan; Brodbelt, Dave; Cave, Nick John

    2016-01-01

    Veterinary practitioners have extensive knowledge of animal health from their day-to-day observations of clinical patients. There have been several recent initiatives to capture these data from electronic medical records for use in national surveillance systems and clinical research. In response, an approach to surveillance has been evolving that leverages existing computerized veterinary practice management systems to capture animal health data recorded by veterinarians. Work in the United Kingdom within the VetCompass program utilizes routinely recorded clinical data with the addition of further standardized fields. The current study describes a prototype system that was developed based on this approach. In a 4-week pilot study in New Zealand, clinical data on presentation reasons and diagnoses from a total of 344 patient consults were extracted from two veterinary clinics into a dedicated database and analyzed at the population level. New Zealand companion animal and equine veterinary practitioners were engaged to test the feasibility of this national practice-based health information and data system. Strategies to ensure continued engagement and submission of quality data by participating veterinarians were identified, as were important considerations for transitioning the pilot program to a sustainable large-scale and multi-species surveillance system that has the capacity to securely manage big data. The results further emphasized the need for a high degree of usability and smart interface design to make such a system work effectively in practice. The geospatial integration of data from multiple clinical practices into a common operating picture can be used to establish the baseline incidence of disease in New Zealand companion animal and equine populations, detect unusual trends that may indicate an emerging disease threat or welfare issue, improve the management of endemic and exotic infectious diseases, and support research activities. This pilot project

  14. Evidence in Practice - A Pilot Study Leveraging Companion Animal and Equine Health Data from Primary Care Veterinary Clinics in New Zealand.

    PubMed

    Muellner, Petra; Muellner, Ulrich; Gates, M Carolyn; Pearce, Trish; Ahlstrom, Christina; O'Neill, Dan; Brodbelt, Dave; Cave, Nick John

    2016-01-01

    Veterinary practitioners have extensive knowledge of animal health from their day-to-day observations of clinical patients. There have been several recent initiatives to capture these data from electronic medical records for use in national surveillance systems and clinical research. In response, an approach to surveillance has been evolving that leverages existing computerized veterinary practice management systems to capture animal health data recorded by veterinarians. Work in the United Kingdom within the VetCompass program utilizes routinely recorded clinical data with the addition of further standardized fields. The current study describes a prototype system that was developed based on this approach. In a 4-week pilot study in New Zealand, clinical data on presentation reasons and diagnoses from a total of 344 patient consults were extracted from two veterinary clinics into a dedicated database and analyzed at the population level. New Zealand companion animal and equine veterinary practitioners were engaged to test the feasibility of this national practice-based health information and data system. Strategies to ensure continued engagement and submission of quality data by participating veterinarians were identified, as were important considerations for transitioning the pilot program to a sustainable large-scale and multi-species surveillance system that has the capacity to securely manage big data. The results further emphasized the need for a high degree of usability and smart interface design to make such a system work effectively in practice. The geospatial integration of data from multiple clinical practices into a common operating picture can be used to establish the baseline incidence of disease in New Zealand companion animal and equine populations, detect unusual trends that may indicate an emerging disease threat or welfare issue, improve the management of endemic and exotic infectious diseases, and support research activities. This pilot project

  15. 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.

  16. Tablet computers with mobile electronic medical records enhance clinical routine and promote bedside time: a controlled prospective crossover study.

    PubMed

    Fleischmann, Robert; Duhm, Julian; Hupperts, Hagen; Brandt, Stephan A

    2015-03-01

    Demographic changes require physicians to deliver needed services with fewer resources. Neurology as an interdisciplinary domain involves complex diagnostic procedures and time-consuming data handling. Tablet PCs might streamline clinical workflow through mobile access to patient data. This study examined the impact of tablets running an electronic medical record on ward round performance. We hypothesised that tablet use should reduce ward round time and decrease the time needed to check medical records thereby increasing physicians' bedside availability. Nine resident neurologists participated in a controlled prospective crossover trial over 14 weeks. In the experimental condition, tablets were used in addition to the established medical record. In the control condition, physicians used established systems only. The combined primary outcome measure included changes in total ward round time and relative time shifts between associated work processes. The secondary outcome measure was physicians' time required to check a medical record vs. physicians' bedside time. There was a significant main effect on the primary outcome measure (p = 0.01). Tablet use accelerated preparing (p = 0.004) and post-processing (p < 0.001) of ward rounds. Time for conducting ward rounds was unaffected (p = 0.19). Checking medical records was faster with tablets (p = 0.001) increasing physicians' bedside time (p < 0.001). Tablet use led to significant time savings during preparing and post-processing of ward rounds. It was further associated with time savings during checking medical data and an increase in physicians' bedside time. Tablets may facilitate clinical data handling and promote workflow.

  17. 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

  18. 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.

  19. Heterogeneity of Monosymptomatic Resting Tremor in a Prospective Study: Clinical Features, Electrophysiological Test, and Dopamine Transporter Positron Emission Tomography

    PubMed Central

    Zheng, Hua-Guang; Zhang, Rong; Li, Xin; Li, Fang-Fei; Wang, Ya-Chen; Wang, Xue-Mei; Lu, Ling-Long; Feng, Tao

    2015-01-01

    Background: The relationship between monosymptomatic resting tremor (mRT) and Parkinson's disease (PD) remains controversial. In this study, we aimed to assess the function of presynaptic dopaminergic neurons in patients with mRT by dopamine transporter positron emission tomography (DAT-PET) and to evaluate the utility of clinical features or electrophysiological studies in differential diagnosis. Methods: Thirty-three consecutive patients with mRT were enrolled prospectively. The Unified Parkinson's Disease Rating Scale and electromyography were tested before DAT-PET. Striatal asymmetry index (SAI) was calculated, and a normal DAT-PET was defined as a SAI of <15%. Scans without evidence of dopaminergic deficits (SWEDDs) were diagnosed in patients with a subsequent normal DAT-PET and structural magnetic resonance imaging. Results: Twenty-eight mRT patients with a significant reduction in uptake of DAT binding in the striatum were diagnosed with PD, while the remained 5 with a normal DAT-PET scan were SWEDDs. As for UPRDS, the dressing and hygiene score, walking in motor experiences of daily living (Part II) and motor examination (Part III) were significant different between two groups (P < 0.05 and P < 0.01, respectively). Bilateral tremor was more frequent in the SWEDDs group (P < 0.05). The frequency of resting tremor and the amplitude of postural tremor tend to be higher in the SWEDDs group (P = 0.08 and P = 0.05, respectively). Conclusions: mRT is heterogeneous in presynaptic nigrostriatal dopaminergic degeneration, which can be determined by DAT-PET brain imaging. Clinical and electrophysiological features may provide clues to distinguish PD from SWEDDs. PMID:26112718

  20. Prospective evaluation of the clinical implications of the tumor metabolism and chemotherapy-related changes in advanced biliary tract cancer.

    PubMed

    Jo, Jaemin; Kwon, Hyun Woo; Park, Seongyeol; Oh, Do-Youn; Cheon, Gi Jeong; Bang, Yung-Jue

    2017-03-02

    Purpose: Tumor metabolism measured by (18)F-fluorodeoxy-D-glucose ((18)F-FDG) positron emission tomography (PET) has a diagnostic and prognostic role in several cancers. The clinical implication of tumor metabolism in biliary tract cancer (BTC) has not been studied well. Therefore, we evaluated the prognostic value of tumor metabolism and chemotherapy-related changes in advanced BTC patients. Materials and Methods: We prospectively enrolled advanced BTC patients before the initiation of palliative chemotherapy. Using (18)F-FDG PET, we assessed the baseline maximum standardized uptake value (SUVmax) and monitored the changes of SUVmax during chemotherapy. We analyzed the associations between SUVmax, and clinicopathologic factors and clinical outcomes. Results: A total of 75 patients were enrolled. All patients received gemcitabine/cisplatin as first-line chemotherapy. Primary tumor site, histologic differentiation, molecular characteristics, laboratory findings, and disease extent were associated with the metabolic characteristics. The high metabolism group showed worse survival outcome [Hazard ratio (HR)=4.09, P = 0.001 for progression-free survival (PFS); HR=2.61, P = 0.019 for overall survival (OS)] than the low metabolism group. The lesser reduction of SUVmax was also associated with worse outcome (HR=3.35, P = 0.002 for PFS; HR=1.96, P = 0.082 for OS). Considering both baseline tumor metabolism and its chemotherapy-related changes, patients with a low metabolism and a more reduction in metabolism obtained the best OS (20.7 months versus 6.2 months, P = 0.013). Conclusion: Tumor metabolic activity and the chemotherapy-related changes in the metabolism are associated with prognosis in advanced BTC patients.

  1. Immediate implants and immediate loading in periodontally compromised patients-a 3-year prospective clinical study.

    PubMed

    Alves, Celia Coutinho; Correia, Andre Ricardo; Neves, Manuel

    2010-10-01

    To avoid the necessity of a removable provisional prosthesis, and therefore preserve the patient's functional outcome, esthetics, and quality of life, a clinical protocol was developed to approach periodontally compromised patients presenting a full-arch irreversibly lost dentition: full-arch extraction and immediate replacement with a provisional acrylic resin implant-supported fixed partial denture (FPD). A total of 23 periodontally compromised patients (11 women, 12 men; 4 smokers, 4 controlled diabetics) were included in this study. Pretreatment casts were taken and vertical dimension of occlusion was determined. In most patients, 6 Straumann implants were distributed along the arch according to the surgical guide or bone availability, with the most distal ones in the maxilla slightly tilted so they could emerge more distally. A total of 168 implants (146 Straumann, 10 Nobel Biocare, 8 Biomet 3i, and 4 Lifecore) were placed (83 in the maxilla, 85 in the mandible). Of those in the maxilla, 74 were loaded immediately (implant stability quotient mentor [ISQm] > 70) and 9 placed with delayed loading (ISQm =/< 70). Of the 85 implants placed in the mandible, all were loaded immediately (ISQm > 70). If an FPD had not been fabricated already, impressions were taken during surgery to do so. The prosthesis was then adapted (cemented or screwed) to the 6 implants within the first 48 hours postsurgery. After 2 months, definitive impressions were taken, and a definitive porcelain-fused-to-metal implant-supported 12-element FPD was fabricated and cemented or screwed to all 6 implants. Of the 168 implants, 108 were immediate implants and 159 immediately loaded. Only 2 implants (1 in the mandible, 1 in the maxilla) did not osseointegrate. This yields a 3-year cumulative survival rate of 98.74% (98.65% in the maxilla, 98.82% in the mandible). From a total of 26 immediately loaded prostheses (12 in the maxilla, 14 in the mandible), 6 were cemented and 20 screw-retained. The 3

  2. 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

  3. Effect of low-dose citrate anticoagulation on the clinical safety and efficacy of direct adsorption of lipoproteins (DALI apheresis) in hypercholesterolemic patients: a prospective controlled clinical trial.

    PubMed

    Bosch, T; Heinemann, O; Duhr, C; Wendler, T; Keller, C; Fink, E; Kirschner, T; Klebert, S; Samtleben, W

    2000-10-01

    Direct adsorption of lipoproteins (DALI) is the first lipid apheresis system compatible with whole blood with the advantage of a very simple procedure. A mixture of heparin plus citrate (ACD-A) is used for the anticoagulation regimen (AR). A clinical, prospective, controlled crossover study was performed to test the safety and efficacy of low-dose citrate (LDC) anticoagulation in DALI. Five chronic DALI patients suffering from coronary heart disease and hypercholesterolemia underwent 3 DALI sessions each using the LDC anticoagulation regimen (60 IU heparin/kg body weight as initial bolus; 1:40 ACD-A: blood as perfusion). This was compared to 3 sessions per patient with the standard AR (bolus of 20 IU heparin/kg, 1:20 ACD-A as perfusion). Patient blood volumes (1.6; average of 7,040 ml) were treated with 750 ml adsorber gel per session at a blood flow rate of 60 ml/min. Mean LDL and Lp(a) reductions exceeded 60% with both AR. No clinical side effects were observed. Both AR controlled the coagulation well as evidenced by a sufficient prolongation of the partial prothrombin time (PTT) and activated clotting time as well as low thrombin-antithrombin (TAT) formation. Biocompatibility parameters exhibited favorable results (low activation of complement and cells, and only slight formation of C3a, C5a, beta-thromboglobulin, elastase, and TNF-alpha). The asymptomatic bradykinin generation was comparable in both study arms. LDC optimized the ionized calcium levels and pH in the efferent blood postadsorber. LDC anticoagulation was safe and effective, and may further improve the tolerance of DALI apheresis in hypercholesterolemic patients.

  4. 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.

  5. 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

  6. 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

  7. The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study

    PubMed Central

    Koorevaar, Rinco C. T.; van ‘t Riet, Esther; Gerritsen, Marleen J. J.; Madden, Kim; Bulstra, Sjoerd K.

    2016-01-01

    Background Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether preoperative symptoms of distress, depression, anxiety and somatisation were associated with a change in function after shoulder surgery and postoperative patient perceived improvement of pain and function. In addition, the change of psychological symptoms after shoulder surgery was analyzed and the influence of postoperative symptoms of psychological disorders after surgery on the change in function after shoulder surgery and perceived postoperative improvement of pain and function. Methods and Findings A prospective longitudinal cohort study was performed in a general teaching hospital. 315 consecutive patients planned for elective shoulder surgery were included. Outcome measures included change of Disabilities of the Arm, Shoulder and Hand (DASH) score and anchor questions about improvement in pain and function after surgery. Psychological symptoms were identified before and 12 months after surgery with the validated Four-Dimensional Symptom Questionnaire (4DSQ). Psychological symptoms were encountered in all the various shoulder diagnoses. Preoperative symptoms of psychological disorders persisted after surgery in 56% of patients, 10% of patients with no symptoms of psychological disorders before surgery developed new psychological symptoms. Preoperative symptoms of psychological disorders were not associated with the change of DASH score and perceived improvement of pain and function after shoulder surgery. Patients with symptoms of psychological disorders after surgery were less likely to improve on the DASH score. Postoperative symptoms of distress and depression were associated with worse perceived improvement of pain. Postoperative symptoms of distress, depression

  8. 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

  9. The Scottish Motor Neuron Disease Register: a prospective study of adult onset motor neuron disease in Scotland. Methodology, demography and clinical features of incident cases in 1989.

    PubMed Central

    1992-01-01

    The Scottish Motor Neuron Disease Register (SMNDR) is a prospective, collaborative, population based study of motor neuron disease (MND) in Scotland. The register started in January 1989 with the aim of studying the clinical and epidemiological features of MND by prospectively identifying incident patients. It is based on a system of registration by recruitment from multiple sources, followed by the collection of complete clinical data and follow up, mainly through general practitioners. In this report the register's methodology and the demography and incidence data for the first year of study are presented. One hundred and fourteen newly diagnosed patients were identified in 1989 giving a crude incidence for Scotland of 2.24/100,000/year. Standardised incidence ratios showed a non-significant trend towards lower rates in north eastern regions and island areas. PMID:1640227

  10. Medicare and Medicaid programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; electronic reporting pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; revision to Quality Improvement Organization regulations. Final rule with comment period.

    PubMed

    2012-11-15

    This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2013 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Inpatient Rehabilitation Facility (IRF) Quality Reporting Program. We are continuing the electronic reporting pilot for the Electronic Health Record (EHR) Incentive Program, and revising the various regulations governing Quality Improvement Organizations (QIOs), including the secure transmittal of electronic medical information, beneficiary complaint resolution and notification processes, and technical changes. The technical changes to the QIO regulations reflect CMS' commitment to the general principles of the President's Executive Order on Regulatory Reform, Executive Order 13563 (January 18, 2011).

  11. Development of a Learning-Oriented Computer Assisted Instruction Designed to Improve Skills in the Clinical Assessment of the Nutritional Status: A Pilot Evaluation

    PubMed Central

    García de Diego, Laura; Cuervo, Marta; Martínez, J. Alfredo

    2015-01-01

    Computer assisted instruction (CAI) is an effective tool for evaluating and training students and professionals. In this article we will present a learning-oriented CAI, which has been developed for students and health professionals to acquire and retain new knowledge through the practice. A two-phase pilot evaluation was conducted, involving 8 nutrition experts and 30 postgraduate students, respectively. In each training session, the software developed guides users in the integral evaluation of a patient’s nutritional status and helps them to implement actions. The program includes into the format clinical tools, which can be used to recognize possible patient’s needs, to improve the clinical reasoning and to develop professional skills. Among them are assessment questionnaires and evaluation criteria, cardiovascular risk charts, clinical guidelines and photographs of various diseases. This CAI is a complete software package easy to use and versatile, aimed at clinical specialists, medical staff, scientists, educators and clinical students, which can be used as a learning tool. This application constitutes an advanced method for students and health professionals to accomplish nutritional assessments combining theoretical and empirical issues, which can be implemented in their academic curriculum. PMID:25978456

  12. Pilot Study to Evaluate the Effect of Topical Dimethicone on Clinical Signs and Skin Barrier Function in Dogs with Naturally Occurring Atopic Dermatitis

    PubMed Central

    Pellicoro, C.; Marsella, R.; Ahrens, K.

    2013-01-01

    This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis. PMID:23710417

  13. Pilot study to evaluate the effect of topical dimethicone on clinical signs and skin barrier function in dogs with naturally occurring atopic dermatitis.

    PubMed

    Pellicoro, C; Marsella, R; Ahrens, K

    2013-01-01

    This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis.

  14. 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

  15. Survival impact of centralization and clinical guidelines for soft tissue sarcoma (A prospective and exhaustive population-based cohort)

    PubMed Central

    Derbel, Olfa; Heudel, Pierre Etienne; Cropet, Claire; Meeus, Pierre; Vaz, Gualter; Biron, Pierre; Cassier, Philippe; Decouvelaere, Anne-Valérie; Ranchere-Vince, Dominique; Collard, Olivier; De Laroche, Eric; Thiesse, Philippe; Farsi, Fadila; Cellier, Dominic; Gilly, François-Noel; Blay, Jean-Yves; Ray-Coquard, Isabelle

    2017-01-01

    Purpose The outcome of sarcoma has been suggested in retrospective and non-exhaustive studies to be better through management by a multidisciplinary team of experts and adherence to clinical practice guidelines (CPGs). The aim of this prospective and exhaustive population based study was to confirm the impact of adherence to CPGs on survival in patients with localized sarcoma. Experimental design Between 2005 and 2007, all evaluable adult patients with a newly diagnosis of localized sarcoma located in Rhone Alpes region (n = 634), including 472 cases of soft-tissue sarcoma (STS), were enrolled. The prognostic impact of adherence to CPGs on progression-free survival (PFS) and overall survival (OS) was assessed by multivariate Cox model in this cohort. Results The median age was 61 years (range 16–92). The most common subtypes were liposarcoma (n = 133, 28%), unclassified sarcoma (n = 98, 20.7%) and leiomyosarcoma (n = 69, 14.6%). In the initial management phase, from diagnosis to adjuvant treatment, the adherence to CPGs for patients with localized STS was 36% overall, corresponding to 56%, 85%, 96% and 84% for initial surgery, radiation therapy, chemotherapy and follow-up, respectively. Adherence to CPGs for surgery was the strongest independent prognostic factor of PFS, along with age, gender, grade, and tumor size. For OS, multivariate analysis adherence to CPGs for surgery was a strong independent prognostic factor, with an important interaction with a management in the regional expert centers. Conclusions This study demonstrates impact of CPGs and treatment within an expert center on survival for STS patients in a whole population-based cohort. PMID:28158190

  16. Outcome of infants and young children with newly diagnosed ependymoma treated on the "Head Start" III prospective clinical trial.

    PubMed

    Venkatramani, Rajkumar; Ji, Lingyun; Lasky, Joseph; Haley, Kelley; Judkins, Alexander; Zhou, Shengmei; Sposto, Richard; Olshefski, Randal; Garvin, James; Tekautz, Tanya; Kennedy, Gloria; Rassekh, Shahrad Rod; Moore, Theodore; Gardner, Sharon; Allen, Jeffrey; Shore, Richard; Moertel, Christopher; Atlas, Mark; Dhall, Girish; Finlay, Jonathan

    2013-06-01

    This study investigates the outcome of children <10 years old with newly-diagnosed ependymoma treated on the prospective multinational "Head Start" III clinical trial. Between April 2004 and July 2009, 19 children with newly-diagnosed ependymoma were enrolled. All children were to receive five induction chemotherapy cycles followed by one consolidation cycle of myelo-ablative chemotherapy and autologous hematopoietic cell rescue. Children between 6 and 10 years of age or with residual tumor prior to consolidation were to receive irradiation thereafter. Median age of 19 children (8 female) was 20 months at diagnosis. Median follow up was 44 months. The primary site was infratentorial in 11 and supratentorial in 8 patients. Gross total resection was achieved in 10 patients. After induction chemotherapy, all three supratentorial ependymoma patients with residual disease achieved a complete response (CR), while only one of six infratentorial patients with residual disease achieved CR. Three infratentorial patients developed progressive disease during induction chemotherapy. All four infratentorial patients with residual disease who underwent autologous hematopoietic cell transplant, failed to achieve CR. Four patients received focal irradiation following chemotherapy. The 3-year event free survival (EFS) and overall survival (OS) for supratentorial ependymoma were 86 ± 13 % and 100 % respectively. The 3-year EFS and OS for infratentorial ependymoma were 27 ± 13 % and 73 ± 13 % respectively. The role of intensive induction and consolidation chemotherapy in deferring irradiation should be investigated further in children with supratentorial ependymoma with residual disease following surgery. This approach appears ineffective in children with infratentorial ependymoma in the absence of irradiation.

  17. 1-year follow-up after radiofrequency tonsillotomy and laser tonsillotomy in children: a prospective, double-blind, clinical study.

    PubMed

    Stelter, Klaus; Ihrler, Stephan; Siedek, Vanessa; Patscheider, Martin; Braun, Thomas; Ledderose, Georg

    2012-02-01

    In the last decade, tonsillotomy has come into vogue again, whereas the number of tonsillectomies is decreasing rapidly. In a previous study, the tonsillotomy with laser or radiofrequency therapy proved as a safe and effective procedure with minimal pain and hemorrhage. This follow-up study determines which method is more effective with respect to long-term outcome, recurrence of tonsillar hyperplasia and recurrence of tonsillitis. A prospective, randomised, double-blinded controlled clinical study was conducted at the Department of Otorhinolaryngology of the Ludwig-Maximilians-University, Munich, Germany. Twenty-six children with tonsillar hypertrophy were included. Tonsillotomy was performed on one side with monopolar radiofrequency and on the other side with a carbon dioxide laser. Exactly 1 year after the procedure, all 26 patients were documented by digital photography to define a possible recurrence of tonsillar hyperplasia. All parents were asked for occurring tonsillitis and fulfilled the Glasgow Children's Benefit Inventory (GCBI) for health-related quality of life after surgical procedures. In seven children, a slightly visible recurrence of the tonsillar hyperplasia occurred, without any symptoms or correlation to the different methods and sides. One child with recurrent tonsillitis and hyperplasia had to be tonsillectomized 8 months after the initial tonsillotomy procedure. The specimen showed open crypts with bacterial infection in the deep. The GCBI resulted in highly significant benefits of the surgery in all categories and subcategories. In conclusion, both methods, the laser tonsillotomy and the radiofrequency method, were equal concerning the effectiveness and safety after 1 year. Further investigations have to aim at the long-term outcome after tonsillotomy in patients with recurrent infections.

  18. Removal of diminutive colorectal polyps: A prospective randomized clinical trial between cold snare polypectomy and hot forceps biopsy

    PubMed Central

    Komeda, Yoriaki; Kashida, Hiroshi; Sakurai, Toshiharu; Tribonias, George; Okamoto, Kazuki; Kono, Masashi; Yamada, Mitsunari; Adachi, Teppei; Mine, Hiromasa; Nagai, Tomoyuki; Asakuma, Yutaka; Hagiwara, Satoru; Matsui, Shigenaga; Watanabe, Tomohiro; Kitano, Masayuki; Chikugo, Takaaki; Chiba, Yasutaka; Kudo, Masatoshi

    2017-01-01

    AIM To compare the efficacy and safety of cold snare polypectomy (CSP) and hot forceps biopsy (HFB) for diminutive colorectal polyps. METHODS This prospective, randomized single-center clinical trial included consecutive patients ≥ 20 years of age with diminutive colorectal polyps 3-5 mm from December 2014 to October 2015. The primary outcome measures were en-bloc resection (endoscopic evaluation) and complete resection rates (pathological evaluation). The secondary outcome measures were the immediate bleeding or immediate perforation rate after polypectomy, delayed bleeding or delayed perforation rate after polypectomy, use of clipping for bleeding or perforation, and polyp retrieval rate. Prophylactic clipping after polyp removal wasn’t routinely performed. RESULTS Two hundred eight patients were randomized into the CSP (102), HFB (106) and 283 polyps were evaluated (CSP: 148, HFB: 135). The en-bloc resection rate was significantly higher with CSP than with HFB [99.3% (147/148) vs 80.0% (108/135), P < 0.0001]. The complete resection rate was significantly higher with CSP than with HFB [80.4% (119/148) vs 47.4% (64/135), P < 0.0001]. The immediate bleeding rate was similar between the groups [8.6% (13/148) vs 8.1% (11/135), P = 1.000], and endoscopic hemostasis with hemoclips was successful in all cases. No cases of perforation or delayed bleeding occurred. The rate of severe tissue injury to the pathological specimen was higher HFB than CSP [52.6% (71/135) vs 1.3% (2/148), P < 0.0001]. Polyp retrieval failure was encountered CSP (7), HFB (2). CONCLUSION CSP is more effective than HFB for resecting diminutive polyps. Further long-term follow-up study is required. PMID:28127206

  19. Histologic Evidence of New Collagen Formulation Using Platelet Rich Plasma in Skin Rejuvenation: A Prospective Controlled Clinical Study

    PubMed Central

    Abuaf, Ozlem Karabudak; Baloglu, Hüseyin; Bilgili, Memet Ersan; Simsek, Hasan Aktug; Dogan, Bilal

    2016-01-01

    Background Platelet-rich plasma (PRP) is an autologous concentration of human platelets contained in a small volume of plasma and has recently been shown to accelerate rejuvenate aging skin by various growth factors and cell adhesion molecules. Objective This study was conducted to evaluate the efficacy and safety of intradermal injection of PRP in the human facial rejuvenation. Methods This study was a prospective, single-center, single-dose, open-label, non-randomized controlled clinical study. PRP injected to the upper site of this right infra-auricular area and all face. Saline was injected to the left infra-auricular area. Histopathological examinations were performed before PRP treatment, 28 days after the PRP, and saline (control) treatments. Results Twenty women ranging in age from 40 to 49 years (mean age, 43.65±2.43 years) were enrolled in the study. The mean optical densities (MODs) of collagen in the pre-treatment, control, and PRP-treated area were measured. They were 539±93.2, 787±134.15, 1,019±178, respectively. In the MOD of PRP, 89.05 percent improvement was found when MOD of PRP was compared with MOD of pre-treatment. The mean MOD of collagen fibers was clearly highest on the PRP side (p<0.001). The PRP-to-saline improvement ratio (89.05% to 46.01%) was 1.93:1. No serious side effects were detected. Conclusion PRP increases dermal collagen levels not only by growth factors, but also by skin needling (the mesotherapy technique 'point by point'). PRP application could be considered as an effective (even a single application) and safety procedure for facial skin rejuvenation. PMID:27904271

  20. 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.

  1. 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.

  2. 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

  3. Recombinant factor IX (BAX326) in previously treated paediatric patients with haemophilia B: a prospective clinical trial.

    PubMed

    Urasinski, T; Stasyshyn, O; Andreeva, T; Rusen, L; Perina, F G; Oh, M S; Chapman, M; Pavlova, B G; Valenta-Singer, B; Abbuehl, B E

    2015-03-01

    A newly developed recombinant factor IX (BAX326(1) ) was investigated for prophylactic use in paediatric patients aged <12 years with severe (FIX level <1%) or moderately severe (FIX level 1-2%) haemophilia B. The aim of this prospective clinical trial was to assess the safety, haemostatic efficacy and pharmacokinetic profile of BAX326 in previously treated paediatric patients. BAX326 was administered as prophylaxis twice a week for a period of 6 months, and on demand for treatment of bleeds. Safety was assessed by the occurrence of related AEs, thrombotic events and immunologic assessments. Efficacy was evaluated by annualized bleeding rate (ABR), and by treatment response rating (excellent, good, fair, none). PK was assessed over 72 h. None of the 23 treated paediatric subjects had treatment-related SAEs or AEs. There were no thrombotic events, inhibitory or specific binding antibodies against FIX, rFurin or CHO protein. Twenty-six bleeds (19 non-joint vs. 7 joint bleeds) occurred (mean ABR 2.7 ± 3.14, median 2.0), of which 23 were injury-related. Twenty subjects (87%) did not experience any bleeds of spontaneous aetiology. Haemostatic efficacy of BAX326 was excellent or good for >96% of bleeds (100% of minor, 88.9% of moderate and 100% of major bleeds); the majority (88.5%) resolved after 1-2 infusions. Longer T1/2 and lower IR were observed in younger children (<6 years) compared to those aged 6 to 12 years. BAX326 administered as prophylactic treatment as well as for controlling bleeds is efficacious and safe in paediatric patients aged <12 years with haemophilia B.

  4. Efficiency of a clinical prediction model for selective rapid testing in children with pharyngitis: A prospective, multicenter study

    PubMed Central

    Cohen, Robert; Bidet, Philippe; Elbez, Annie; Levy, Corinne; Bossuyt, Patrick M.; Chalumeau, Martin

    2017-01-01

    Background There is controversy whether physicians can rely on signs and symptoms to select children with pharyngitis who should undergo a rapid antigen detection test (RADT) for group A streptococcus (GAS). Our objective was to evaluate the efficiency of signs and symptoms in selectively testing children with pharyngitis. Materials and methods In this multicenter, prospective, cross-sectional study, French primary care physicians collected clinical data and double throat swabs from 676 consecutive children with pharyngitis; the first swab was used for the RADT and the second was used for a throat culture (reference standard). We developed a logistic regression model combining signs and symptoms with GAS as the outcome. We then derived a model-based selective testing strategy, assuming that children with low and high calculated probability of GAS (<0.12 and >0.85) would be managed without the RADT. Main outcomes and measures were performance of the model (c-index and calibration) and efficiency of the model-based strategy (proportion of participants in whom RADT could be avoided). Results Throat culture was positive for GAS in 280 participants (41.4%). Out of 17 candidate signs and symptoms, eight were retained in the prediction model. The model had an optimism-corrected c-index of 0.73; calibration of the model was good. With the model-based strategy, RADT could be avoided in 6.6% of participants (95% confidence interval 4.7% to 8.5%), as compared to a RADT-for-all strategy. Conclusions This study demonstrated that relying on signs and symptoms for selectively testing children with pharyngitis is not efficient. We recommend using a RADT in all children with pharyngitis. PMID:28235012

  5. The foot-health of people with diabetes in a regional Australian population: a prospective clinical audit

    PubMed Central

    2012-01-01

    Background There is limited understanding of the foot-health of people with diabetes in Australian regional areas. The aim of this study was to document the foot-health of people with diabetes who attend publically funded podiatric services in a regional Australian population. Methods A three month prospective clinical audit was undertaken by the publically-funded podiatric services of a large regional area of Victoria, Australia. The primary variables of interest were the University of Texas (UT) diabetic foot risk classification of each patient and the incidence of new foot ulceration during the study period. Age, gender, diabetes type, duration of diabetes and the podiatric service the patients attended were the other variables of interest. Results Five hundred and seventy six patients were seen during the three month period. Over 49% had a UT risk classification at a level at least peripheral neuropathy or more serious diabetes-related foot morbidity. Higher risk at baseline was associated with longer duration of diabetes (F = 31.7, p < 0.001), male gender (χ2 = 40.3, p <0.001) and type 1 diabetes (χ2 = 37.3, p <0.001). A prior history of foot pathology was the overwhelming predictor for incident ulceration during the time period (OR 8.1 (95% CI 3.6 to 18.2), p < 0.001). Conclusions The publically funded podiatric services of this large regional area of Australia deal with a disproportionally large number of people with diabetes at high risk of future diabetes-related foot complications. These findings may be useful in ensuring appropriate allocation of resources for future public health services involved in diabetic foot health service delivery in regional areas. PMID:22400802

  6. 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