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Sample records for prospective efficacy evaluation

  1. The Efficacy of Intraoperative Neuromonitoring During Robotic Thyroidectomy: A Prospective, Randomized Case-Control Evaluation.

    PubMed

    Lee, Hye Yoon; Lee, Ju-Young; Dionigi, Gianlorenzo; Bae, Jeoung Won; Kim, Hoon Yub

    2015-11-01

    This study evaluates the efficacy of intraoperative neuromonitoring (IONM) on voice performance in robotic thyroidectomy. The study was based on a prospective randomized series. Between June 2011 to September 2012, 50 patients with thyroid cancer who underwent robotic thyroidectomy were enrolled. The IONM and non-IONM groups consisted of 25 patients each. Voice Handicap Index (VHI), voice range profile (VRP), and laryngoscopy were used to assess voice function before surgery and at 2 weeks, 3 months, and 6 months after the operation. No palsy was diagnosed by laryngoscopy in either group. VHI values were similar in both groups. In the IONM group, there was significantly earlier recovery in VRP minimum intensity compared with the non-IONM group. However, there were no differences of mean change of VRP maximum frequency and intensity or minimum frequency between the two groups. We found that IONM facilitated more rapid recovery of voice function, especially in VRP minimum intensity, during robotic thyroid surgery.

  2. A prospective study to evaluate the efficacy of isopropyl alcohol irrigations to prevent cerumen impaction.

    PubMed

    Silverstein, Herbert; Wycherly, Benjamin J; Alameda, Yadiel; Van Ess, Mark J

    2012-03-01

    We conducted a prospective crossover study to assess the safety and efficacy of 70% isopropyl alcohol delivered from a squeezable bottle with a specially designed tip as a weekly irrigant to reduce cerumen accumulation. Twenty patients were divided into 2 groups of 10 (20 ears in each group). The patients in group 1 instilled 70% isopropyl alcohol once a week for 2 months; this was followed by 2 months of no ear cleaning. The patients in group 2 performed the opposite routine. At each visit (0, 2, and 4 mo), cerumen accumulation was graded on a scale of 0 to 4, indicating 0, 25, 50, 75, and 100% occlusion, respectively. After the accumulation was graded, a cerumenectomy was performed. At the initial evaluation, the mean occlusion scores were 3.1 for group 1 and 3.3 for group 2-not a statistically significant difference. After the first 2 months of the study, there was a significant difference in occlusion scores between groups 1 and 2 (0.75 and 1.55, respectively; p < 0.0002). At 4 months, after the crossover, the occlusion scores were 1.15 and 0.95, respectively, not a significant difference (p = 0.38). At study's end, there were also significant differences within each group between occlusion scores obtained during the treatment and nontreatment periods (group 1: p < 0.02; group 2: p < 0.01). All patients tolerated the alcohol rinse well, and there were no cases of external otitis or other complications. We conclude that weekly irrigation with 70% isopropyl alcohol is safe and reduces the accumulation of cerumen in the external auditory canal. Routine use should decrease the number of office visits for cerumen removal and hearing aid cleaning.

  3. METODO, a prospective observational study to assess the efficacy and tolerability of methadone in heroin-addicted patients undergoing a methadone maintenance treatment: preliminary results at baseline evaluation.

    PubMed

    D'Egidio, Pietro Fausto; Bignamini, Emanuele; De Vivo, Enrico; Leonardi, Claudio; Pieri, Maria Chiara; González-Saiz, Francisco; Lucchini, Alfio

    2013-12-01

    METODO (methadone efficacy therapy optimization dosage on-going) is a prospective observational study to assess the efficacy and tolerability of methadone in 500 heroin-addicted patients taking a methadone maintenance treatment, enrolled through 2010 to 2011 in five Italian sites, observed over 2 years. The Opiate Dosage Adequacy Scale has been used for the evaluation of the "adequacy" of the methadone dosage and to stratify patients in adequate and not adequate groups. The treatment efficacy has been evaluated in correlation to the dosage adequacy during the visits. Moreover, patients have been evaluated according to the retention rate and duration of retention in treatment and a series of questionnaires.

  4. Prospective efficacy and safety evaluation of laser treatments with real-time temperature feedback for fungal onychomycosis.

    PubMed

    Waibel, Jill; Wulkan, Adam Jared; Rudnick, Ashley

    2013-11-01

    Onychomycosis affects five percent of the worldwide population. Onychomycosis is a therapeutic challenge. Current therapies on the market are either ineffective or require patient monitoring. Laser and light technologies are being investigated as a possible treatment option for onychomycosis. The proposed mechanism of action is unknown. All infectious agents may be killed by heat (except prions). One possible theory is the photothermal effect from water absorbing lasers creates bulk heating in the nail plate to kill fungal hyphae. Laser technology may be a promising new treatment option for onychomycosis. This is a prospective trial with real-time temperature feedback to evaluate efficacy and safety of laser therapy for onychomycosis. Twenty-one patients with PAS or culture proven fungal onychomycosis were prospectively treated with laser until target temperature of 46 - 48 degrees Celsius was achieved using real-time infrared temperature feedback. The laser and light therapies used were 1319 nm, 1064 nm and BroadBand Light. Exclusion criteria included mixed infection and no other prior therapeutic interventions. Subjects received four treatment sessions one week apart. Assessments included PAS & cultures at one, three and six months post treatment. Patients also were asked a pain score from 1-10 during treatment. Patients tolerated the procedures well with high satisfaction. Average treatment time was 10 minutes. No adverse events were noted. Patients reported mild-moderate transient discomfort during treatment. Six-month culture results revealed 20/21 negative for fungal organisms. Laser therapy offers a safe and effective new option for onychomycosis. This may be the optimal therapy for a large market that needs alternative or adjunct to current therapies. Laser is quick, painless therapy that does not require any oral medications or blood test for monitoring. Additional larger scientific studies are needed to confirm our pilot study results.

  5. [Application and prospect of scale measurement and appraisal in the assessment in TCM therapeutic efficacy evaluation].

    PubMed

    Liu, Feng-Bin

    2007-12-01

    The assessing contents of the health related quality of life (HRQOL) and the patient reported outcomes (PRO) are identical with the inquiry of traditional Chinese medicine (TCM), which are uniformly soft indicators which could be evaluated with the scales for instruments. The assessing method for the soft indicator in the HRQOL and PRO was gradually accepted by TCM practitioners and applied in evaluating the curative effect of TCM. The applying scale in the assessment of curative effect of TCM and the developing scale with the TCM features just started in the TCM field. There was much inadequacy in the scale study, such as no penetrating understanding of the theory and connotation of the scale in the HRQOL and PRO, on scale system for TCM, no direction in selecting scale, not standardizing in the design of the study with scale in the practice. So, it is necessary that the international guideline of developing scale applied for worldwide should be carried out in the study for developing scale. Meanwhile, it must also be under the guidance of TCM theory in the whole course. It will promote the normalization development of applying scale in the assessment of curative effect in the TCM practice.

  6. [Axillary hyperhidrosis--efficacy and tolerability of an aluminium chloride antiperspirant. Prospective evaluation on 20 patients with idiopathic axillary hyperhidrosis].

    PubMed

    Streker, M; Reuther, T; Verst, S; Kerscher, M

    2010-02-01

    The purpose of this study was to evaluate the efficacy and tolerability of aluminium chloride gel for treatment of axillary hyperhidrosis. A total of 20 patients aged 22-38 (mean age: 26.9+/-4.3) with idiopathic axillary hyperhidrosis were included and treated with an antiperspirant (Sweat-off, Sweat-off GmbH, Hügelsheim). Study duration was 42 days. Treatment efficacy was evaluated clinically, as well as by starch-iodine test, gravimetric analysis and evaluation of the skin surface pH. After treatment there was a significant clinical improvement accompanied by significant qualitative and quantitative reduction of sweat as well as a significant reduction of skin surface pH. Except for slight skin irritation in 6 patients, there were no other side effects. Patient satisfaction improved markedly during the study. Treatment of axillary hyperhidrosis with aluminium chloride is an effective, safe and inexpensive treatment modality.

  7. Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study

    PubMed Central

    Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

    2016-01-01

    Introduction Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. Aim The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. Materials and Methods In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Results Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. Conclusion The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions. PMID:27630951

  8. Prospective study to evaluate safety and efficacy of Zotarolimus Eluting Stent (PSEZES) in patients with long coronary artery lesions

    PubMed Central

    Bahuleyan, C.G.; Krishna Kumar, V.V.; Babu, Shifas

    2015-01-01

    Background Although the safety and effectiveness of Drug-Eluting Stents (DES) has been established extensively, reports on long term clinical outcome with angiographic findings in patients with long coronary artery lesions are not many. Methods In this single-center prospective registry of 100 patients, a total of 110 denovo long lesions (>20 mm) were treated with Resolute Zotarolimus Eluting Stent (R-ZES). The patients were followed up clinically at 3, 6 and 12 months and follow up coronary angiography was performed at 9-months. The primary end point was one year rate of target lesion failure (TLF) which is a composite of cardiac death, target lesion myocardial infarction or ischemia driven target lesion revascularization (TLR). The secondary end points included definite or probable stent thrombosis, 9-month angiographic restenosis and late lumen loss. Results The mean age of patients was 58.7 ± 9.50 years with prevalence of diabetes as high as 60%. The mean lesion length was 24.67 ± 4.87 mm with a mean reference vessel diameter of 2.85 ± 0.32 mm and 67.3% were Type C lesions (ACC/AHA classification). Two patients died during follow-up, of which one was non-cardiac death. One patient had target vessel myocardial infarction and five patients (4.5%) had ischemia driven TLR. The incidence of TLF was 6.36%. Binary restenosis was seen in 7 out of 93 lesions (7.5%). Median late lumen loss at 9 month was 0.22 mm. No stent thrombosis was noted in the study. Conclusion Implantation of R-ZES in real-world patients with long coronary artery lesions is safe with comparable efficacy to what is observed in the treatment of less complex lesions. PMID:26138180

  9. Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study.

    PubMed

    Patel, Harsh S; Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

    2016-07-01

    Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions.

  10. Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study.

    PubMed

    Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Rao, T Divakara; Gupta, Yogendra Kumar

    2015-01-01

    In the traditional system of medicine in India Ashwagandha powder and Sidh Makardhwaj have been used for the treatment of rheumatoid arthritis. However, safety and efficacy of this treatment have not been evaluated. Therefore, the present study was carried out to evaluate the efficacy and safety of Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj) in patients with rheumatoid arthritis. One hundred and twenty five patients with joint pain were screened at an Ayurvedic hospital in New Delhi, India. Eighty six patients satisfied inclusion criteria and were included in the study. Detailed medical history and physical examination were recorded. Patients took 5g of Ashwagandha powder twice a day for three weeks with lukewarm water or milk. Sidh Makardhwaj (100 mg) with honey was administered daily for the next four weeks. The follow up of patients was carried out every two weeks. The primary efficacy end point was based on American College of Rheumatology (ACR) 20 response. Secondary end points were ACR50, ACR70 responses, change from baseline in disease activity score (DAS) 28 score and ACR parameters. Safety assessments were hepatic function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin and ß2 microglobulin], renal function (urea and creatinine and NGAL) tests and urine mercury level. The study was completed by 90.7 per cent (78/86) patients. Patients with moderate and high disease activity were 57.7 per cent (45/78) and 42.3 per cent (33/78), respectively. All patients were tested positive for rheumatoid factor and increased ESR level. Ashwagandha and Sidh Makardhwaj treatment decreased RA factor. A significant change in post-treatment scores of tender joint counts, swollen joint counts, physician global assessment score, patient global assessment score, pain assessment score, patient self assessed disability index score and ESR level were observed as compared to baseline scores. ACR20 response was

  11. Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study

    PubMed Central

    Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Rao, T. Divakara; Gupta, Yogendra Kumar

    2015-01-01

    Background & objectives: In the traditional system of medicine in India Ashwagandha powder and Sidh Makardhwaj have been used for the treatment of rheumatoid arthritis. However, safety and efficacy of this treatment have not been evaluated. Therefore, the present study was carried out to evaluate the efficacy and safety of Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj) in patients with rheumatoid arthritis. Methods: One hundred and twenty five patients with joint pain were screened at an Ayurvedic hospital in New Delhi, India. Eighty six patients satisfied inclusion criteria and were included in the study. Detailed medical history and physical examination were recorded. Patients took 5g of Ashwagandha powder twice a day for three weeks with lukewarm water or milk. Sidh Makardhwaj (100 mg) with honey was administered daily for the next four weeks. The follow up of patients was carried out every two weeks. The primary efficacy end point was based on American College of Rheumatology (ACR) 20 response. Secondary end points were ACR50, ACR70 responses, change from baseline in disease activity score (DAS) 28 score and ACR parameters. Safety assessments were hepatic function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin and ß2 microglobulin], renal function (urea and creatinine and NGAL) tests and urine mercury level. Results: The study was completed by 90.7 per cent (78/86) patients. Patients with moderate and high disease activity were 57.7 per cent (45/78) and 42.3 per cent (33/78), respectively. All patients were tested positive for rheumatoid factor and increased ESR level. Ashwagandha and Sidh Makardhwaj treatment decreased RA factor. A significant change in post-treatment scores of tender joint counts, swollen joint counts, physician global assessment score, patient global assessment score, pain assessment score, patient self assessed disability index score and ESR level were observed as

  12. A Prospective Randomized Controlled Two-Arm Clinical Study Evaluating the Efficacy of a Bioelectric Dressing System for Blister Management in US Army Ranger Recruits.

    PubMed

    Housler, Greggory J; Cross, Sue; Marcel, Vanessa; Kennedy, Daniel O; Husband, Michael; Register, Andrew; Roberts, Thomas; Grubbs, Seth; Dudewicz, Douglas; Setka, Nathan; Bay, Curt; Wendelken, Martin E; Izadjoo, Mina J

    This study focused on a clinically relevant healthcare problem in the military: acute soft tissue wounds, or blisters. The trial was a prospective, controlled, randomized two-arm study evaluating the efficacy of a bioelectric dressing, Procellera®, applied topically two to three times per week for 2 weeks to blisters developed in Ranger trainees during training at Fort Benning, Georgia. A total of 80 US Army Ranger recruits with blister wounds below the knee were randomly assigned to one of two treatment groups (n = 40/group). The primary goal was to assess the clinical efficacy (rate of healing) of administered Procellera in conjunction with the standard-of-care (SOC) treatment, moleskin and Tegaderm ®, on the healing rate of blisters compared with the SOC treatment alone. The secondary end points for efficacy were the quantities of wound fluid biomarkers and bacterial bioburden. The tertiary end point was assessment of pain in the treatment group compared with that of the control group during the 2-week study. The results showed no statistical difference between the SOC and SOC+Procellera groups in wound healing and pain. Wound fluid was reported for 24 participants (64.9%) in the SOC group and 21 participants (56.8%) in SOC+Procellera group at the baseline measurement (ρ = .475); however, the wounds were devoid of fluid on follow-up visits. The mild nature of the wounds in this study was apparent by the low pain scores at the beginning of the study, which disappeared by the follow-up visits. The average wound sizes were 2.2cm2 and 1.5cm2 for the SOC and SOC+Procellera groups, respectively. This trial protocol should be conducted on open softtissue wounds in severe heat. To our knowledge, this is the first clinical study conducted within the US Army Rangers training doctrine. 2017.

  13. Safety and efficacy evaluation of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) in dyslipidemia patients: A pilot prospective cohort clinical study

    PubMed Central

    Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Gupta, Yogendra Kumar

    2012-01-01

    Cardiovascular disease has multifaceted in which dyslipidemia, inflammation, and immunity play an important role. Arjuna powder and Arogyavardhini Vati used for centuries has potential for combating these factors. Therefore, the objective of this study was to evaluate the safety and efficacy of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) for dyslipidemia patients. Total of 108 patients were screened at CGHS Ayurvedic Hospital, New Delhi. Ninety-six patients satisfied inclusion criteria, and signed informed consent and detailed medical history was recorded. Arjuna powder (5 g, BD) for 3 weeks and then Arogyavardhini Vati (500 mg, BD) for 4 weeks were prescribed to the patients. The primary efficacy endpoint was reduction in serum total cholesterol, LDL, triglycerides, and increased HDL levels. Secondary endpoints included reduction in serum C-Reactive Protein (CRP) and blood glucose levels. Safety assessments included hepatic function (aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), bilirubin, and β2 microglobulin), renal function (urea and creatinine and NGAL) tests, and urine mercury level. The study was completed by 87 patients. The male and female patients were 65.5% (57/87) and 34.5% (30/87), respectively. There was a significant reduction in total cholesterol, LDL, triglycerides, CRP, and blood glucose. However, raised HDL level was also observed. Safety assessment results showed no significant change in serum ALT, AST, ALP and bilirubin, urea, creatinine β2 microglobulin, and NGAL levels at the end of study as compared to the baseline levels. In conclusion, the results of the present prospective cohort study showed that Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) is safe and effective for dyslipidemia. PMID:23559790

  14. A prospective comparative field study to evaluate the efficacy of a traditional plant-based malaria prophylaxis.

    PubMed

    Nagendrappa, Prakash Bangalore; Annamalai, Pradeep; Naik, Muruli; Mahajan, Vinay; Mathur, Ashwini; Susanta, Ghosh; Gay, Frederick; Venkatasubramanian, Padma

    2017-01-01

    An unceasing threat of resistance of malarial parasites to available antimalarial drugs makes the development of new drugs imperative. Natural plant-based products are an alternative source for discovering new antimalarial drugs. To determine the prophylactic efficacy of a traditionally used plant-based drug on prevention of malaria in endemic villages of Odisha, India. A total of 267 healthy human volunteers of both sexes, aged 18-60 years were enrolled in Odisha, India, to receive either minimum 20 doses of aqueous extract of Traditional Plant-based Malaria Prophylactic drug 74, twice a week (experimental group), or no drug (control group) for 14 weeks. The primary criterion was the occurrence of malaria positive cases confirmed through expert microscopy during the study period. Analyses were by per-protocol (PP) and modified intention-to-treat (mITT). A significant (P < 0.01) reduction (64%) of malaria incidence was observed in the experimental group compared to control group, 12.3% and 26.6%, respectively, as PP analysis. However, the reduction was nonsignificant as per mITT analysis (P = 0.22). The experimental group showed a relative risk of 0.36 compared to control group. This preliminary study constitutes a potential "proof of concept" for the development of malaria prophylactic drug and provide a scientific basis for the use of traditional remedy as a malaria preventive by tribal populations in India.

  15. A prospective comparative field study to evaluate the efficacy of a traditional plant-based malaria prophylaxis

    PubMed Central

    Nagendrappa, Prakash Bangalore; Annamalai, Pradeep; Naik, Muruli; Mahajan, Vinay; Mathur, Ashwini; Susanta, Ghosh; Gay, Frederick; Venkatasubramanian, Padma

    2017-01-01

    Background: An unceasing threat of resistance of malarial parasites to available antimalarial drugs makes the development of new drugs imperative. Natural plant-based products are an alternative source for discovering new antimalarial drugs. Aim: To determine the prophylactic efficacy of a traditionally used plant-based drug on prevention of malaria in endemic villages of Odisha, India. Methods: A total of 267 healthy human volunteers of both sexes, aged 18-60 years were enrolled in Odisha, India, to receive either minimum 20 doses of aqueous extract of Traditional Plant-based Malaria Prophylactic drug 74, twice a week (experimental group), or no drug (control group) for 14 weeks. The primary criterion was the occurrence of malaria positive cases confirmed through expert microscopy during the study period. Analyses were by per-protocol (PP) and modified intention-to-treat (mITT). Results: A significant (P < 0.01) reduction (64%) of malaria incidence was observed in the experimental group compared to control group, 12.3% and 26.6%, respectively, as PP analysis. However, the reduction was nonsignificant as per mITT analysis (P = 0.22). The experimental group showed a relative risk of 0.36 compared to control group. Conclusion: This preliminary study constitutes a potential “proof of concept” for the development of malaria prophylactic drug and provide a scientific basis for the use of traditional remedy as a malaria preventive by tribal populations in India. PMID:28163958

  16. Evaluation of the efficacy of Fructus agni casti in women with severe primary dysmenorrhea: a prospective comparative Doppler study.

    PubMed

    Aksoy, Ayse Nur; Gözükara, Ilay; Kabil Kucur, Suna

    2014-03-01

    The aim of this case-control study was to compare the efficacy of ethinyl estradiol/drospirenone and Fructus agni casti in women with severe primary dysmenorrhea measuring uterine artery blood flow via Doppler ultrasonography. A total of 60 women with severe primary dysmenorrhea and 30 healthy women (control) were included in this study. Thirty patients were treated with ethinyl estradiol 0.03 mg/drospirenone (group 1) and another 30 were treated with Fructus agni casti (group 2) during three menstrual cycles. Before and at the end of third month of therapy visual analog scale (VAS) scores, pulsatility index (PI), resistance index (RI) of uterine artery were recorded before and after receiving therapy on the first day of the menstrual cycle. Mean PI and RI values in patients with severe primary dysmenorrhea were significantly higher than in the control groups on the first day of the menstrual cycle (P < 0.0001). Mean PI and RI values were significantly lower after the treatment in both groups compared to before values (P < 0.001 for both). After using the drugs for three menstrual cycles, VAS scores were significantly dropped in both groups compared to before treatment values (P < 0.0001 for both); however, there were no significant differences in terms of Doppler findings between group 1 and 2. The effectiveness of Fructus agni casti was similar to that of ethinyl estradiol/drospirenone in patients with primary dysmenorrhea. © 2013 The Authors. Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology.

  17. Evaluating the efficacy of lavender aromatherapy on peripheral venous cannulation pain and anxiety: A prospective, randomized study.

    PubMed

    Karaman, Tugba; Karaman, Serkan; Dogru, Serkan; Tapar, Hakan; Sahin, Aynur; Suren, Mustafa; Arici, Semih; Kaya, Ziya

    2016-05-01

    This study was designed to evaluate the effectiveness of lavender aromatherapy on pain, anxiety, and level of satisfaction associated with the peripheral venous cannulation (PVC) in patients undergoing surgery. One hundred and six patients undergoing surgery were randomized to receive aromatherapy with lavender essential oil (the lavender group) or a placebo (the control group) during PVC. The patients' pain, anxiety, and satisfaction scores were measured. There was no statistically significantly difference between the groups in terms of demographic data. After cannulation, the pain and anxiety scores (anxiety 2) of the patients in the lavender group were significantly lower than the control group (for p = 0.01 for pain scores; p < 0.001 for anxiety 2 scores). In addition, patient satisfaction was significantly higher in the lavender group than in the control group (p = 0.003). Lavender aromatherapy had beneficial effects on PVC pain, anxiety, and satisfaction level of patients undergoing surgery. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Prospective Evaluation of Cetuximab-Mediated Antibody-Dependent Cell Cytotoxicity in Metastatic Colorectal Cancer Patients Predicts Treatment Efficacy.

    PubMed

    Trotta, Anna Maria; Ottaiano, Alessandro; Romano, Carmela; Nasti, Guglielmo; Nappi, Anna; De Divitiis, Chiara; Napolitano, Maria; Zanotta, Serena; Casaretti, Rossana; D'Alterio, Crescenzo; Avallone, Antonio; Califano, Daniela; Iaffaioli, Rosario Vincenzo; Scala, Stefania

    2016-04-01

    Cetuximab is a monoclonal antibody to the EGFR that induces antibody-dependent cell cytotoxicity (ADCC) through Fcγ receptors on immune cells. Although SNPs in genes encoding Fcγ receptors are functionally relevant to cetuximab-mediated ADCC in colorectal cancer, a direct correlation between in vitro ADCC and clinical response to cetuximab is not defined. We therefore enrolled 96 consecutive metastatic colorectal cancer (mCRC) patients at diagnosis in a study that assessed FcγR status and cetuximab-mediated ADCC. Patients carrying the FcγRIIa H alleles 131H/Hand 131H/R had significantly higher ADCC compared with patients with the 131R/R alleles (P= 0.013). Patients carrying FcγRIIIa genotypes with the V alleles 158V/V and 158V/F displayed higher ADCC compared with patients carrying the 158F/F genotype (P= 0.001). Progression-free survival of patients with an FcγRIIIa 158V allele was significantly longer compared with patients carrying 158F/F (P= 0.05), whereas no significant difference was observed for overall survival. Twenty-eight of 50 mCRC patients with wild-type KRAS received cetuximab. The average ADCC-mediated killing was 30% of assay targets for patients who experienced cetuximab complete or partial response, 21% in patients with stable disease and 9% in patients with progressive disease. To characterize basal natural killer (NK) activity, cytotoxicity was evaluated in 39 of 96 mCRC patients. Patients who responded to first-line treatment had higher NK-cell cytotoxicity. Thus, although limited to this cohort of patients, in vitro cetuximab-mediated ADCC correlated with FcγR polymorphisms and predicted cetuximab responsiveness. ©2016 American Association for Cancer Research.

  19. A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy.

    PubMed

    Sun, Yuanjue; Shu, Yongqian; Liu, Baorui; Liu, Ping; Wu, Changping; Zheng, Rongsheng; Zhang, Xiaohua; Zhuang, Zhixiang; Deng, Yongchuan; Zheng, Leizhen; Xu, Qing; Jiang, Bin; Ouyang, Xuenong; Gao, Jianfei; Xu, Nong; Li, Xiaoyi; Jiang, Su; Liang, Chaofan; Yao, Yang

    2016-12-01

    The present study aimed to evaluate the efficacy and safety of acetyl-L-carnitine (ALC) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). The study was carried out as a prospective, randomized, double-blind, placebo-controlled and paralleled clinical study. A total of 239 patients with CIPN were selected as the study subjects. Of the 239 subjects, 118 subjects received 3 g/day ALC orally for 8 weeks and 121 received a placebo. The primary endpoint was improvement of peripheral neuropathy by at least one grade. Patient status was assessed at week 4, 8 and 12 after enrollment into the study. In both the full analysis set (FAS) and the per-protocol set (PPS), peripheral sensory neuropathy was significantly ameliorated in the ALC group with 50.5 and 51.6% patients meeting the primary endpoint at week 8, compared with 24.1 and 23.1% of patients in the placebo group (P<0.001 in both sets). Secondary endpoints, such as the nerve electrophysiological examination and the Karnofsky physical score were also significantly improved in patients receiving ALC treatment, as compared with the placebo group (FAS, P=0.0463 and P=0.022; PPS, P=0.0076 and P=0.0064, respectively). Cancer-associated fatigue was significantly alleviated following ALC treatment in the PPS (P=0.0135). In the safety analysis set, the difference in adverse events incidence between the two groups was not statistically significant (P=0.3903). There were only two severe adverse events in the ALC group, which were not associated with the effect of ALC. In conclusion, the results of the present study demonstrated that in Chinese patients with cancer, oral administration of ALC is effective at ameliorating peripheral sensory neuropathy induced by chemotherapy, as well as reducing of cancer-associated fatigue and improving physical conditions.

  20. A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy

    PubMed Central

    Sun, Yuanjue; Shu, Yongqian; Liu, Baorui; Liu, Ping; Wu, Changping; Zheng, Rongsheng; Zhang, Xiaohua; Zhuang, Zhixiang; Deng, Yongchuan; Zheng, Leizhen; Xu, Qing; Jiang, Bin; Ouyang, Xuenong; Gao, Jianfei; Xu, Nong; Li, Xiaoyi; Jiang, Su; Liang, Chaofan; Yao, Yang

    2016-01-01

    The present study aimed to evaluate the efficacy and safety of acetyl-L-carnitine (ALC) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). The study was carried out as a prospective, randomized, double-blind, placebo-controlled and paralleled clinical study. A total of 239 patients with CIPN were selected as the study subjects. Of the 239 subjects, 118 subjects received 3 g/day ALC orally for 8 weeks and 121 received a placebo. The primary endpoint was improvement of peripheral neuropathy by at least one grade. Patient status was assessed at week 4, 8 and 12 after enrollment into the study. In both the full analysis set (FAS) and the per-protocol set (PPS), peripheral sensory neuropathy was significantly ameliorated in the ALC group with 50.5 and 51.6% patients meeting the primary endpoint at week 8, compared with 24.1 and 23.1% of patients in the placebo group (P<0.001 in both sets). Secondary endpoints, such as the nerve electrophysiological examination and the Karnofsky physical score were also significantly improved in patients receiving ALC treatment, as compared with the placebo group (FAS, P=0.0463 and P=0.022; PPS, P=0.0076 and P=0.0064, respectively). Cancer-associated fatigue was significantly alleviated following ALC treatment in the PPS (P=0.0135). In the safety analysis set, the difference in adverse events incidence between the two groups was not statistically significant (P=0.3903). There were only two severe adverse events in the ALC group, which were not associated with the effect of ALC. In conclusion, the results of the present study demonstrated that in Chinese patients with cancer, oral administration of ALC is effective at ameliorating peripheral sensory neuropathy induced by chemotherapy, as well as reducing of cancer-associated fatigue and improving physical conditions. PMID:28105133

  1. Prospective evaluation of intense pulsed light and meibomian gland expression efficacy on relieving signs and symptoms of dry eye disease due to meibomian gland dysfunction.

    PubMed

    Dell, Steven J; Gaster, Ronald N; Barbarino, Sheila C; Cunningham, Derek N

    2017-01-01

    The aim of this study was to estimate the efficacy of intense pulsed light (IPL), followed by meibomian gland expression (MGX), for reducing the number and severity of signs and symptoms of dry eye disease (DED) secondary to meibomian gland dysfunction (MGD). In a prospective study conducted in two sites, 40 subjects (80 eyes) with moderate to severe MGD were enrolled. Major inclusion criteria consisted of at least two of the following measures being compatible with DED in both eyes: tear breakup time (TBUT), meibomian gland score (MGS), corneal fluorescein staining (CFS), Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and tear film osmolarity (TFO). Enrolled patients underwent four treatment sessions, 3 weeks apart. Each treatment included the administration of 10-15 pulses of IPL on the cheeks and nose, followed by MGX of the upper and lower eyelids. TBUT, MGS, CFS, SPEED, TFO, and lipid layer thickness (LLT) were measured at baseline (BL) and at 9, 12, and 15 weeks after BL. Due to different staining methods used for TBUT measurements, TBUT and CFS were analyzed separately for each site. From BL to the final follow-up, the number of signs compatible with DED decreased from 3.3±0.1 to 1.4±0.1. TBUT improved by +93% (n=38; P<0.0001) and +425% (n=42; P<0.0001) for sites 1 and 2, respectively. SPEED, MGS, and CFS improved by -55% (n=80; P<0.0001), -36% (n=80; P<0.0001), and -58% (n=38; P<0.0001), respectively. In 20 eyes with abnormally elevated TFO at BL, TFO improved by -7% (n=20; P<0.005). LLT did not change (n=38; P=0.88). In subjects with moderate to severe MGD, IPL combined with MGX reduced the number and severity of symptoms and signs of DED. Except for LLT, all examined outcome measures significantly improved after 15 weeks. These results support the efficacy of IPL + MGX in relieving both signs and symptoms of DED secondary to MGD.

  2. Prospective evaluation of intense pulsed light and meibomian gland expression efficacy on relieving signs and symptoms of dry eye disease due to meibomian gland dysfunction

    PubMed Central

    Dell, Steven J; Gaster, Ronald N; Barbarino, Sheila C; Cunningham, Derek N

    2017-01-01

    Purpose The aim of this study was to estimate the efficacy of intense pulsed light (IPL), followed by meibomian gland expression (MGX), for reducing the number and severity of signs and symptoms of dry eye disease (DED) secondary to meibomian gland dysfunction (MGD). Patients and methods In a prospective study conducted in two sites, 40 subjects (80 eyes) with moderate to severe MGD were enrolled. Major inclusion criteria consisted of at least two of the following measures being compatible with DED in both eyes: tear breakup time (TBUT), meibomian gland score (MGS), corneal fluorescein staining (CFS), Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and tear film osmolarity (TFO). Enrolled patients underwent four treatment sessions, 3 weeks apart. Each treatment included the administration of 10–15 pulses of IPL on the cheeks and nose, followed by MGX of the upper and lower eyelids. TBUT, MGS, CFS, SPEED, TFO, and lipid layer thickness (LLT) were measured at baseline (BL) and at 9, 12, and 15 weeks after BL. Results Due to different staining methods used for TBUT measurements, TBUT and CFS were analyzed separately for each site. From BL to the final follow-up, the number of signs compatible with DED decreased from 3.3±0.1 to 1.4±0.1. TBUT improved by +93% (n=38; P<0.0001) and +425% (n=42; P<0.0001) for sites 1 and 2, respectively. SPEED, MGS, and CFS improved by −55% (n=80; P<0.0001), −36% (n=80; P<0.0001), and −58% (n=38; P<0.0001), respectively. In 20 eyes with abnormally elevated TFO at BL, TFO improved by −7% (n=20; P<0.005). LLT did not change (n=38; P=0.88). Conclusion In subjects with moderate to severe MGD, IPL combined with MGX reduced the number and severity of symptoms and signs of DED. Except for LLT, all examined outcome measures significantly improved after 15 weeks. These results support the efficacy of IPL + MGX in relieving both signs and symptoms of DED secondary to MGD. PMID:28496300

  3. 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

  4. A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg

    PubMed Central

    Festin, Mario P.R.; Bahamondes, Luis; Nguyen, Thi My Huong; Habib, Ndema; Thamkhantho, Manopchai; Singh, Kuldip; Gosavi, Arundhati; Bartfai, Gyorgy; Bito, Tamas; Bahamondes, M. Valeria; Kapp, Nathalie

    2016-01-01

    STUDY QUESTION Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? SUMMARY ANSWER Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. WHAT IS KNOWN ALREADY LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. STUDY DESIGN, SIZE, DURATION This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 330 healthy fertile women aged 18–45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability

  5. A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg.

    PubMed

    Festin, Mario P R; Bahamondes, Luis; Nguyen, Thi My Huong; Habib, Ndema; Thamkhantho, Manopchai; Singh, Kuldip; Gosavi, Arundhati; Bartfai, Gyorgy; Bito, Tamas; Bahamondes, M Valeria; Kapp, Nathalie

    2016-03-01

    Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. A total of 330 healthy fertile women aged 18-45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability questions were administered. There were 321 women included in the evaluable population (which includes all eligible women

  6. Evaluation of the safety and efficacy of recombinant soluble thrombomodulin for patients with disseminated intravascular coagulation associated with acute leukemia: multicenter prospective study by the Tohoku Hematology Forum.

    PubMed

    Yokoyama, Hisayuki; Takahashi, Naoto; Katsuoka, Yuna; Inomata, Mitsue; Ito, Toshihiro; Meguro, Kuniaki; Kameoka, Yoshihiro; Tsumanuma, Riko; Murai, Kazunori; Noji, Hideyoshi; Ishizawa, Kenichi; Ito, Shigeki; Onishi, Yasushi; Harigae, Hideo

    2017-02-07

    It has been suggested that use of recombinant soluble thrombomodulin (rTM) is superior to conventional drugs in treatment of disseminated intravascular coagulation (DIC) complicating acute leukemia. However, its safety and efficacy have not been fully examined in prospective studies. Here, we performed a multicenter prospective study to examine outcomes of rTM treatment for DIC in patients with acute leukemia. Of 33 patients registered in this study, 13 had acute myeloid leukemia (AML), three had acute lymphoblastic leukemia (ALL), and 17 had acute promyelocytic leukemia (APL). The cumulative rates of DIC resolution at day 7 and day 35 were 56 and 81% in AML/ALL and 53 and 77% in APL, respectively. The median time from the initiation of rTM to DIC resolution was 4 days in AML/ALL and 6 days in APL patients. Adverse events related to hemorrhage occurred in two AML/ALL patients (13%) and three APL patients (18%). Of these, one AML/ALL patient died with intracranial hemorrhage, and two APL patients died with intracranial hemorrhage and pulmonary hemorrhage. These results suggest that rTM may improve the survival of acute leukemia patients with DIC by inhibiting early death related to hemorrhagic events, as reported previously.

  7. Academic Self-Efficacy and Prospective ELT Teachers' Achievement

    ERIC Educational Resources Information Center

    Sariçoban, Arif; Behjoo, Bahram Mohammadi

    2016-01-01

    This study aims to scrutinize the possible relationship between academic self-efficacy beliefs and foreign language achievement among prospective ELT teachers. To do so, the data for the study were collected through a questionnaire, "College Academic Self-Efficacy Scale" adapted from Owen & Froman (1988), consisting of 33 items…

  8. A Prospective, Multicentre, Open-Label Single-Arm Exploratory Study to Evaluate Efficacy and Safety of Saroglitazar on Hypertriglyceridemia in HIV Associated Lipodystrophy

    PubMed Central

    Joshi, Shashank

    2016-01-01

    Objective This study was designed to explore the efficacy and safety of saroglitazar 4 mg on hypertriglyceridemia in patients with HIV associated lipodystrophy. Methods During this 12-week prospective, multi-centric, open-label, single arm exploratory study, 50 patients were enrolled to receive saroglitazar 4 mg orally once daily in the morning before breakfast. The primary efficacy endpoint was the percent change in triglyceride (TG) levels from baseline to Week 6 and Week 12. The secondary efficacy endpoints were assessment of low-density-lipoprotein (LDL), very-low-density-lipoprotein (VLDL), high-density-lipoprotein (HDL), non-HDL cholesterol, total cholesterol, apo-lipoprotein (Apo) A1, Apo B, and C-peptide and fasting insulin for HOMA beta and HOMA IR. Safety assessment was performed during the study. Results Saroglitazar 4 mg significantly decreased the serum TG levels from baseline at Week 6 (percent change: -40.98; 95% CI: -50.82, -31.15) and Week 12 (percent change -45.11; 95% CI: -52.37, -37.86). Reduction in VLDL cholesterol (percent change: -46.33; 95% CI: -52.89, -39.76) and total cholesterol (percent change: 7.37; 95% CI: 1.96, 12.78) was observed at week 12 from baseline. Saroglitazar increased HDL cholesterol (percent change: 34.56, 95% CI: 22.22, 46.90), Apo A1 (percent change: 33.16; 95% CI: 18.69, 47.63) and Apo B (percent change: 10.55, 95% CI: 2.86, 18.25) levels at week 12 from baseline. Saroglitazar treatment led to increase in the C-peptide (percent change: 59.42, 95% CI: 48.78, 70.06), fasting insulin levels (percent change: 47.10; 95% CI: 38.63, 55.57), HOMA of beta cell function for C-peptide (percent change: 71.67; 95% CI: 39.09, 104.26) and HOMA of insulin resistance for C-peptide (percent change: 58.29, 95% CI: 46.74, 69.83) at week 12 from baseline. Saroglitazar treatment was safe and well tolerated in this study. Conclusion Overall, the observed changes in lipid profile after 12 weeks of saroglitazar treatment were in the direction

  9. A prospective, randomized single-blind evaluation of effect of injection speed on anesthetic efficacy of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis.

    PubMed

    Aggarwal, Vivek; Singla, Mamta; Miglani, Sanjay; Kohli, Sarita; Irfan, Mohammad

    2012-12-01

    Speed of injection may affect the solution spread in the pterygomandibular space. It was hypothesized that speed of injection will affect the anesthetic efficacy of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. Fifty-nine adult volunteers who were actively experiencing pain participated in this prospective, randomized, single-blind study. The patients were divided into 2 groups on a random basis and received either slow or rapid IANB with 3.6 mL of 2% lidocaine with 1:200,000 epinephrine. Endodontic access preparation was initiated after 15 minutes of the initial IANB. Pain during treatment was recorded by using the Heft-Parker visual analogue scale. The primary outcome measure, and the definition of success, was the ability to undertake pulp access and canal instrumentation with no or mild pain (Heft-Parker visual analog scale score < 55 mm). Secondary outcome measure was the solution deposition pain. Statistical analysis was performed by using Mann-Whitney U test and χ(2) test. Slow and rapid injections gave 43% and 51% success rates, respectively. The difference was statistically insignificant. Slow injections produced less solution deposition pain than rapid injections. Rate of injection has no effect on anesthetic success of IANB, but slow injections were more comfortable than rapid injections. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  10. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study.

    PubMed

    Agarwal, Anil; Nath, S S; Goswami, Debolina; Gupta, Devendra; Dhiraaj, Sanjay; Singh, Prabhat K

    2006-10-01

    Postoperative sore throat (POST), although a minor complication, remains a source of postoperative morbidity. We compared the efficacy of dispersible aspirin gargle to benzydamine hydrochloride (a topical nonsteroidal anti inflammatory drug) gargles for prevention of POST. We enrolled 60 consecutive female patients, 16-60 yr of age, ASA physical status I or II, undergoing elective modified radical mastectomy under general anesthesia in this prospective, randomized, placebo-controlled, single-blind study. Patients were randomly divided into 3 groups of 20 subjects each: Group 1 (C) mineral water; Group 2 (AS) tab aspirin 350 mg; and Group 3 (BH) 15 mL of benzydamine hydrochloride (0.15%). All the medications were made into 30 mL of solution. Patients were asked to gargle this mixture for 30 s, 5 min before induction of anesthesia. Grading of POST was done at 0, 2, 4, and 24 h postoperatively on a 4-point scale (0-3). Aspirin gargles reduced the incidence of POST for 4 h whereas benzydamine hydrochloride gargles reduced POST for 24 h. POST was more severe in the control group at 0 and 2 h (P < 0.05). Aspirin and benzydamine hydrochloride gargles significantly reduced the incidence and severity of POST (P < 0.05).

  11. Results of a multicenter prospective clinical study in Japan for evaluating efficacy and safety of desensitization protocol based on rituximab in ABO-incompatible kidney transplantation.

    PubMed

    Takahashi, Kota; Saito, Kazuhide; Takahara, Shiro; Fuchinoue, Shohei; Yagisawa, Takashi; Aikawa, Atsushi; Watarai, Yoshihiko; Yoshimura, Norio; Tanabe, Kazunari; Morozumi, Kunio; Shimazu, Motohide

    2017-08-01

    Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy. Mycophenolate mofetil and low dose steroid were started 28 days pretransplant, followed by two doses of rituximab 375 mg/m(2) at day -14 and day -1, and postoperative immunosuppression with tacrolimus or ciclosporin and basiliximab. The primary endpoint was the non-occurrence rate of acute antibody-mediated rejection. Patient survival and graft survival were monitored for 1 year posttransplant. Eighteen patients received rituximab and underwent ABO-incompatible kidney transplantation. CD19-positive peripheral B cell count decreased rapidly after the first rituximab infusion and recovered gradually after week 36. The desensitization protocol was tolerable, and most rituximab-related infusion reactions were mild. No anti-A/B antibody-mediated rejection occurred with this series. One patient developed anti-HLA antibody-mediated rejection (Banff 07 type II) on day 2, which was successfully managed. Patient and graft survival were both 100 % after 1 year. Our desensitization protocol was confirmed to be clinically effective and with acceptable toxicities for ABO-I-KTx (University Hospital Medical Information Network Registration Number: UMIN000006635).

  12. [The preclinical efficacy of emergency care. A prospective study].

    PubMed

    Hennes, H J; Reinhardt, T; Otto, S; Dick, W

    1993-07-01

    Quality assurance has become an important issue in emergency medicine. At present, no prospective studies are available that quantify the efficacy of interventions performed by emergency doctors. The development and implementation of a rapid, yet simple scoring system, allowing preclinical assessment of all emergency medicine patients, is required. Once the scoring system is implemented, evaluation of the prehospital intervention, based upon objective parameters, is possible. METHODS. The Mainz Emergency Evaluation Score (MEES) is based on seven parameters: level of consciousness, heart rate, heart rhythm, arterial blood pressure, respiratory rate, partial arterial oxygen saturation and pain. A coded value is assigned to each parameter, with the normal physiological condition securing a score of 4, while a life-threatening condition receives a value of 1. For the parameter of pain there is no life-threatening condition, so the lowest value allowed is 2 (Table 2). Addition of the respective values from the seven parameters yields the MEES value, which objectively reflects the patients' condition (minimum = 8, maximum = 28). Comparing the MEES value before (MEES1) and after the intervention (MEES2) allows an objective evaluation of the efficacy of the preclinical care (delta-MEES = MEES2-MEES1). A difference of > or = +2 is considered an improvement, +1, +/- 0, -1 are rated as unchanged and < or = -2 is considered a deterioration in the patients condition. For more detailed evaluation the patients were allocated to 16 diagnosis groups (Table 3). Statistical evaluation utilized analysis of variance, the rank sum test (Wilcoxon) and the correlation coefficient (Kendall-Tau). RESULTS. In 356 patients the condition of 187 (52%) patients improved during the preclinical treatment; the condition of 156 (44%) patients did not change. In 13 patients (3%) the condition became worse (Table 5, Fig. 2). Allocation to 16 diagnosis groups revealed that the improvement in the

  13. Management of allergic conjunctivitis: an evaluation of the perceived comfort and therapeutic efficacy of olopatadine 0.2% and azelastine 0.05% from two prospective studies

    PubMed Central

    Epstein, Arthur B; Van Hoven, Peter T; Kaufman, Alan; Carr, Warner W

    2009-01-01

    Purpose: Results from 2 patient-reported outcome studies of allergic conjunctivitis sufferers who used olopatadine 0.2% and azelastine 0.05% are analyzed. Methods: The PACE (Pataday Allergic Conjunctivitis Evaluation) multi-center, prospective, open-label study examined patient perceptions of olopatadine 0.2% once daily (qd) and previous twice daily (bid) allergic conjunctivitis medications via questionnaire in allergic conjunctivitis sufferers who had previously used bid medication and then initiated olopatadine. A second conjunctival antigen challenge (CAC) study evaluated comfort of 4 allergic conjunctivitis medications. Results: Forty-nine patients from the PACE study (N = 125) with prior azelastine use were examined. Significantly more patients rated themselves “very satisfied” with current olopatadine use compared with past azelastine use on drop comfort (p < 0.0001), speed of relief (p = 0.0004), and overall satisfaction (70% vs 16%, p < 0.0001). Significantly more patients reported olopatadine “very effective” against swelling compared with azelastine (47% vs 8%, p = 0.0404). In the CAC study (N = 36), data from olopatadine (n = 8), azelastine (n = 9) and placebo (N = 36) groups were reported. Olopatadine was rated significantly more comfortable than azelastine upon instillation (p = 0.0223), at 30 seconds (p = 0.0479), and at 1 minute after instillation (p = 0.0240). Conclusion: In the reported studies, olopatadine 0.2% qd was more comfortable than azelastine 0.05% and preferred by patients with allergic conjunctivitis by a ratio of 4:1. PMID:19668586

  14. Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.

    PubMed

    Ando, Kenji; Ishii, Katsuhisa; Tada, Eiji; Kataoka, Kazuaki; Hirohata, Atsushi; Goto, Kenji; Kobayashi, Katsuyuki; Tsutsui, Hiroshi; Nakahama, Makoto; Nakashima, Hitoshi; Uchikawa, Shinichiroh; Kanda, Junji; Yasuda, Satoshi; Yajima, Junji; Kitabayashi, Hiroshi; Sakurai, Shumpei; Nakanishi, Keita; Inoue, Naoto; Noike, Hirofumi; Hasebe, Terumitsu; Sato, Tetsuya; Yamasaki, Masao; Kimura, Takeshi

    2017-07-01

    The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt-chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION(®)). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7-19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION(®) (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION(®). All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.

  15. Employing observational method for prospective data collection: A case study for analyzing diagnostic process and evaluating efficacy of TCM treatments for diabetes mellitus.

    PubMed

    Gu, Xuelan; Huang, Nan; Gu, Jie; Joshi, Manoj Kumar; Wang, Hongqiang

    2016-11-04

    With the mounting pandemic of glucose metabolism dysregulation and type 2 Diabetes Mellitus (T2DM), traditional medicine such as traditional Chinese medicine (TCM) recipes has been widely adopted as a part of therapeutic approach, especially in Asian countries. A novel approach, which is adopted from cohort studies from epidemiology has been applied to explore the clinical efficacy, as well as the herbal component selection of a variety of TCM formulations against T2DM. In the current study, 98 newly diagnosed T2DM patients were recruited in two hospitals. Over a span of 4 weeks, the patients were treated by prescriptions of their individual TCM physicians. General TCM symptoms, blood glucose parameters, as well as general metabolic health biomarkers were evaluated over the therapy period. The pattern of which herbs were used, together with association between blood glucose level change and the use of herbs, were analyzed. TCM diabetic syndrome diagnosis was made by physicians based on symptoms, who prescribed herbal TCM medication afterwards for individual subjects. The results showed significant reduction in fasting and postmeal glucose levels, as well as insulin after the TCM treatment regimen as compared to baseline. As secondary endpoint, total triglyceride level decreased over the period of study as well. Kudzuvine root, Rhemannia root, Figwoot root, and Mulberry leaf were the top herbs associated with pronounced glucose reduction. In conclusion, an observational study on a cohort of patients receiving TCM therapy has shown good clinical outcome for T2DM patients receiving TCM treatments. Association analysis on herbal usage and clinical outcome suggested opportunity in constructing optimized formulation for superior efficacy with future studies at a larger scale. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. In vitro safety and efficacy evaluations of a complex botanical mixture of Eugenia dysenterica DC. (Myrtaceae): Prospects for developing a new dermocosmetic product.

    PubMed

    Moreira, Larissa Cleres; de Ávila, Renato Ivan; Veloso, Danillo Fabrini Maciel Costa; Pedrosa, Tatiana Nascimento; Lima, Emerson Silva; do Couto, Renê Oliveira; Lima, Eliana Martins; Batista, Aline Carvalho; de Paula, José Realino; Valadares, Marize Campos

    2017-04-04

    In the context of developing a new natural product-based cosmetic, the in vitro efficacy and safety evaluations of a complex botanical mixture based on Eugenia dysenterica leaf hydroalcoholic extract (EDE) (2.5-1000μg/mL) were carried out. Chromatographic analysis demonstrated the presence of the tannin (ellagic acid) and flavonoids (quercetin and gallic acid) which characterize the EDE as a polyphenol-rich mixture. Using HFF-1 fibroblasts, it was shown that EDE promoted cell regeneration after UVA exposure. It also led to the inhibition of the collagenase, elastase and tyrosinase enzymes, which are involved in skin-related disorders. In terms of toxicological evaluation, the EDE was classified as non-phototoxic through the 3T3 Neutral Red Uptake Phototoxicity Test (OECD N° 432, 2004) and non-eye irritant by Bovine Corneal Opacity and Permeability (OECD N° 437, 2013) assay, in conjunction with corneal histomorphometric analysis. Furthermore, the EDE has no skin sensitization potential as demonstrated by a two-out-of-three prediction model [protein-binding/haptenization (OECD N° 442C, 2015), keratinocyte and dendritic cell activations]. In addition, it was shown that the EDE seems to be non-genotoxic through the cytokinesis-block micronucleus assay (OECD N° 487, 2014) using HepG2 cells. When considered together, these findings support the use of EDE botanical mixture in cosmetic/pharmaceutical products.

  17. “The ABCs of AD”: A prospective evaluation of the efficacy of an educational intervention to increase knowledge of autonomic dysreflexia management among emergency health care professionals

    PubMed Central

    Krassioukov, Andrei; Tomasone, Jennifer R.; Pak, Melissa; Craven, B. Catharine; Ghotbi, Mohammad H.; Ethans, Karen; Martin Ginis, Kathleen A.; Ford, Michael; Krassioukov-Enns, Dmitri

    2016-01-01

    Context/Objective Despite the availability of consensus-based resources, first responders and emergency room (ER) health care professionals (HCPs) have limited knowledge regarding autonomic dysreflexia (AD) recognition and treatment. The purpose of this study was to assess the efficacy of “The ABCs of AD” educational seminar for improving HCPs’ short- and long-term knowledge of AD recognition, diagnosis, and management. Design Multi-center prospective pre, post, and follow-up questionnaire study. Setting Level I trauma centers with emergency departments in British Columbia, Manitoba, and Ontario. Methods ER professionals completed measures immediately before and after (n = 108), as well as 3-months following (n = 23), attendance at “The ABCs of AD” seminar. Outcome Measures AD knowledge test; seminar feedback. Results Following the seminar, participants had higher ratings of their AD knowledge and had significantly higher AD knowledge test scores (M ± SD pre = 11.85 ± 3.88, M ± SD post = 18.95 ± 2.39, out of 22; P < 0.001, d = 2.21). Most participants believed the seminar changed their AD knowledge, and rated the seminar information as having the potential to influence and change their practice. AD knowledge test scores significantly decreased between post-seminar and 3-month follow-up (M ± SD 3mo = 17.04 ± 3.28; P = 0.004, d = –0.70); however, 3-month scores remained significantly higher than baseline. Conclusion “The ABCs of AD” seminar improves HCPs’ perceived and actual AD knowledge in the short-term. To enhance knowledge retention in both the short- and long-term, the inclusion of additional active learning strategies and follow-up activities are recommended. The seminar is being translated into an online training module to enhance the dissemination of the AD clinical practice guidelines among first responders, ER staff, and SCI practitioners. PMID:26108353

  18. "The ABCs of AD": A prospective evaluation of the efficacy of an educational intervention to increase knowledge of autonomic dysreflexia management among emergency health care professionals.

    PubMed

    Krassioukov, Andrei; Tomasone, Jennifer R; Pak, Melissa; Craven, B Catharine; Ghotbi, Mohammad H; Ethans, Karen; Martin Ginis, Kathleen A; Ford, Michael; Krassioukov-Enns, Dmitri

    2016-01-01

    Despite the availability of consensus-based resources, first responders and emergency room (ER) health care professionals (HCPs) have limited knowledge regarding autonomic dysreflexia (AD) recognition and treatment. The purpose of this study was to assess the efficacy of "The ABCs of AD" educational seminar for improving HCPs' short- and long-term knowledge of AD recognition, diagnosis, and management. Multi-center prospective pre, post, and follow-up questionnaire study. Level I trauma centers with emergency departments in British Columbia, Manitoba, and Ontario. ER professionals completed measures immediately before and after (n = 108), as well as 3-months following (n = 23), attendance at "The ABCs of AD" seminar. AD knowledge test; seminar feedback. Following the seminar, participants had higher ratings of their AD knowledge and had significantly higher AD knowledge test scores (M ± SD pre = 11.85 ± 3.88, M ± SD post = 18.95 ± 2.39, out of 22; P < 0.001, d = 2.21). Most participants believed the seminar changed their AD knowledge, and rated the seminar information as having the potential to influence and change their practice. AD knowledge test scores significantly decreased between post-seminar and 3-month follow-up (M ± SD 3mo = 17.04 ± 3.28; P = 0.004, d = -0.70); however, 3-month scores remained significantly higher than baseline. "The ABCs of AD" seminar improves HCPs' perceived and actual AD knowledge in the short-term. To enhance knowledge retention in both the short- and long-term, the inclusion of additional active learning strategies and follow-up activities are recommended. The seminar is being translated into an online training module to enhance the dissemination of the AD clinical practice guidelines among first responders, ER staff, and SCI practitioners.

  19. Differentiated Instruction: Hong Kong Prospective Teachers' Teaching Efficacy and Beliefs

    ERIC Educational Resources Information Center

    Wan, Sally Wai-Yan

    2016-01-01

    Catering for learner diversity is one of the key areas in the recent educational reform in Hong Kong. Pre-service teacher education acts as a fundamental way to equip pre-service teachers ready for accommodating diverse learning needs and to build up pre-service teachers' self-efficacy. The purpose of the study is to examine prospective teachers'…

  20. Prospective use of serial questionnaires to evaluate the therapeutic efficacy of 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) in suspected lung cancer

    PubMed Central

    Herder, G; van Tinteren, H; Comans, E; Hoekstra, O; Teule, G; Postmus, P; Joshi, U; Smit, E

    2003-01-01

    Background: A study was undertaken to study the effect of 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) on the diagnosis and management of clinically problematic patients with suspected non-small cell lung cancer (NSCLC). Methods: A prospective before-after study was performed in a cohort of all 164 patients (university/community settings) referred for PET between August 1997 and July 1999. PET was restricted to cases where non-invasive tests had failed to solve clinical problems. The impact on diagnostic understanding and management was assessed using questionnaires (intended treatment without PET, actual treatment choice after PET, post hoc clinical assessment). Results: Diagnostic problems especially pertained to unclear radiological findings (n=112; 63%), mediastinal staging (n=36; 20%), and distant staging issues (n=16; 9%). PET findings were validated by reviewing medical records. PET had a positive influence on diagnostic understanding in 84%. Improved diagnostic understanding solely based on PET was reported in 26%. According to referring physicians, PET resulted in beneficial change of treatment in 50%. Cancelled surgery was the most frequent change in treatment after PET (35%). Conclusion: FDG PET applied as "add on" technology in patients with these clinical problems appears to be a clinically useful tool, directly improving treatment choice in 25% of patients. The value of increased confidence induced by PET scanning requires further evaluation. PMID:12511720

  1. A prospective multicentre study to evaluate the efficacy and tolerability of osmotic release oral system (OROS®) hydromorphone in opioid-naive cancer patients: Results of the Korean South West Oncology Group study

    PubMed Central

    Song, Eun-Kee; Shim, Hyunjeong; Han, Hye-Suk; Sun, DerSheng; Lee, Soon-Il; Kang, Myung Hee; Lee, KyuTaek; Cho, DoYeun; Cho, In Sung; Park, Suk Young; Kim, Samyong; Yim, Chang-Yeol

    2015-01-01

    BACKGROUND: Osmotic release oral system (OROS®) hydromorphone is a potent, long-acting opioid analgesic, effective and safe for controlling cancer pain in patients who have received other strong opioids. To date, few studies have examined the efficacy of hydromorphone for pain relief in opioid-naive cancer patients. OBJECTIVES: A prospective, open-label, multicentre trial was conducted to determine the efficacy and tolerability of OROS hydromorphone as a single and front-line opioid therapy for patients experiencing moderate to severe cancer pain. METHODS: OROS hydromorphone was administered to patients who had not previously received strong, long-acting opioids. The baseline evaluation (visit 1) was followed by two evaluations (visits 2 and 3) performed two and 14 weeks later, respectively. The starting dose of OROS hydromorphone was 4 mg/day and was increased every two days when pain control was insufficient. Immediate-release hydromorphone was the only accepted alternative strong opioid for relief of breakthrough pain. The efficacy, safety and tolerability of OROS hydromorphone, including the effects on quality of life, and patients’ and investigators’ global impressions on pain relief were evaluated. The primary end point was pain intensity difference (PID) at visit 2 relative to visit 1 (expressed as %PID). RESULTS: A total of 107 patients were enrolled in the present study. An improvement in pain intensity of >50% (≥50% PID) was observed in 51.0% of the full analysis set and 58.6% of the per-protocol set. The mean pain score, measured using a numerical rating scale, was significantly reduced after two weeks of treatment, and most adverse events were manageable. Quality of life also improved, and >70% of patients and investigators were satisfied with the treatment. CONCLUSIONS: OROS hydromorphone provided effective pain relief and improved quality of life in opioid-naive cancer patients. As a single and front-line treatment, OROS hydromorphone delivered

  2. Evaluation of the Analgesic Efficacy of Melatonin in Patients Undergoing Cesarean Section Under S pinal Anesthesia: A Prospective Randomized Double-blind Study

    PubMed Central

    Beigom Khezri, Marzieh; Delkhosh Reihany, Morteza; Oveisy, Sonia; Mohammadi, Navid

    2016-01-01

    Melatonin has been suggested as a new natural pain killer in inflammatory pain and during surgical procedures. We designed this randomized double-blind controlled study to evaluate the analgesic efficacy and also optimal preemptive dose of melatonin in patients undergoing cesarean section under spinal anesthesia . One hundred twenty patients scheduled for cesarean section under spinal anesthesia were randomly allocated to one of three groups of 40 each to receive melatonin 3 milligram (mg) (group M3), melatonin 6 mg (group M6) or placebo (group P) sublingually 20 min before the spinal anesthesia. The time to first analgesic request, analgesic requirement in the first 24 h after surgery, hemodynamic variables, anxiety scores nd the incidence of adverse events were recorded. The duration of anesthesia and analgesia didn’t show significant differences between three groups. Total analgesic request during 24 h after surgery was different among the three groups (P = 0.035). The incidence of headache in group M6 was significantly higher than others (P<0.001). However, after adjusting headache between groups of the study, we were unable to show the significant difference in the total analgesic request during 24 h after surgery among the three groups (p = 0.058). Although premedication of patients with 3 mg sublingual melatonin prolonged time to first analgesic request after cesarean delivery compared to placebo group, the difference was not statistically significant. Meanwhile increasing dose of melatonin to 6 mg failed to enhance analgesia and also increase the incidence of headache in patients undergoing cesarean section under spinal anesthesia. PMID:28243296

  3. Evaluation of efficacy of amikacin for attenuation of catheter-related bladder discomfort in patients undergoing percutaneous nephrolithotomy: A prospective, randomized, placebo-controlled, double-blind study

    PubMed Central

    Verma, Ruchi; Agarwal, Anil; Singh, Prabhat Kumar; Gupta, Devendra; Shamim, Rafat

    2016-01-01

    Context: Catheter-related bladder discomfort (CRBD) is the most distressing symptom in patients due to intraoperative urinary catheterization. Amikacin significantly inhibits detrusor contraction evoked by prejunctional stimulation. Aims: The aim of this study is to evaluate the efficacy of amikacin in prevention of CRBD in patients undergoing percutaneous nephrolithotomy. Settings and Design: Study areas were operation theater and postanesthesia care unit of the Department of Anesthesiology, SGPGIMS, Lucknow. Subjects and Methods: One hundred adult patients of either sex were randomly assigned into two groups of fifty each. Patients in control group received normal saline whereas patients in amikacin group received amikacin 10 mg/kg just before induction. Grading of CRBD was done as none, mild, moderate, and severe by a blinded observer at 0, 1, 6, 12, and 24 h after surgery. Statistical Analysis Used: Data were analyzed using Student's t-test and Chi-square test among groups. Incidence of CRBD was compared with Chi-square test whereas severity was analyzed by the test of proportions (Z-test). Visual analog score was compared using Mann–Whitney U-test for surgical site pain. Results: Incidence of CRBD in control group was 66% as compared to 44% observed in amikacin group (P < 0.05). During intergroup comparison at different time points, incidence of CRBD was reduced at 1 and 6 h in the amikacin group (P < 0.05). Significant reduction in the severity of CRBD (moderate) was also observed at 1 h in the amikacin group (P < 0.05). At rest of the time points, there was no significant difference. Conclusions: Amikacin can significantly reduce the incidence and severity of CRBD in the first few hours after surgery. PMID:27746561

  4. Prospective Evaluation of Ventriculostomy Infections

    PubMed Central

    Worley, Emmagene; Astle, Sonia

    2015-01-01

    Introduction: Hospital-acquired infections associated with external drainage of ventricular cerebrospinal fluid (CSF) are a significant source of concern for the patients and the provider team alike. Traditional rates of ventriculostomy infection range from 10-17% in a time-dependent fashion. Changing physician and nursing practices fueled this concern over infections.  Objective: We sought to prospectively identify the risk factors associated with ventriculostomy infections as part of a quality assurance project.  Methods: One hundred consecutive patients were evaluated and data were collected on 91. The primary indications for ventriculostomy were subarachnoid hemorrhage (46%), intracerebral hemorrhage (24%), and trauma (22%). Variables prospectively evaluated included pre-incision antibiotics, sterile technique bundling, setting of placement (operating room versus intensive care unit), experience of operator (attending, resident, or physician assistant), catheter type (antibiotic impregnated or not), use of a post-insertion dressing, and in-dwell time of the catheter.  Results: There was only one infection in 91 patients (1.1%). This infection occurred in a patient without an antibiotic-impregnated catheter that was inserted by a resident physician. Compliance with pre-insertion antibiotics was very high, but most other variables had modest deviations in compliance. Conclusion: Infection rate related to external ventricular drainage is very low. Our data suggest that non-antibiotic impregnated catheters may be associated with infection, but that other variables thought to be critical may be of less value. PMID:26430586

  5. Pre-release efficacy test of the prospective biological control agent Arytinnis hakani on the invasive weed Genista monspessulana

    USDA-ARS?s Scientific Manuscript database

    In weed biological control, conducting a pre-release efficacy test can help ascertain if prospective biological control agents will be capable of controlling the target plant. Currently, the phloem-feeding psyllid, Arytinnis hakani, is being evaluated as a prospective agent for the exotic invasive w...

  6. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

    PubMed Central

    2010-01-01

    Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1), single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to <2.75 mm that compares TAXUS Element with a matched historical bare metal Express stent control. Discussion The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541. PMID:20059766

  7. Prospective evaluation of myopic keratomileusis.

    PubMed

    Swinger, C A; Barker, B A

    1984-07-01

    The initial results of a prospective evaluation of myopic keratomileusis are reported. The procedure was attempted on 42 eyes, with an average follow-up of 10 months. The average reductions of myopia were 7.05 D and 11.59 D when measured by keratometry and refraction, respectively. Regular astigmatism increased by 0.50 D on keratometry, but there was no change in the refractive cylinder. The majority of patients had some irregular astigmatism on corneoscopy. The average percent correction, based on refraction, was 94.1 +/- 24%, and the correlation coefficient was 0.43. Visual rehabilitation was rapid. No patient followed for 1 year or more had a decrease in the best-corrected acuity, and 63% of this group had an average improvement of 1.5 lines with as much as five lines. The final refraction may take up to 6 months to stabilize. Complications consisted of epithelium and debris in the interface and focal necrosis of Bowman's membrane. The technique is difficult but may have application in the visual rehabilitation of the high myope.

  8. Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China

    PubMed Central

    Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

    2016-01-01

    Background: High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. Methods: A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. Results: A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit (−9.5%). Conclusions: This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with

  9. Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

    PubMed

    Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

    2016-11-20

    High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

  10. Prospective clinical and histological study to evaluate the efficacy and safety of a targeted high-intensity narrow band UVB/UVA1 therapy for striae alba.

    PubMed

    Sadick, Neil S; Magro, Cynthia; Hoenig, Alison

    2007-06-01

    The purpose of this study was to determine the efficacy and safety of a targeted narrow band UVB/UVA1 therapy for the treatment of striae alba. Fourteen individuals with skin types II-VI were enrolled in this 22-week trial that consisted of up to 10 treatments with a combination of UVB/UVA1 (MultiClear, Curelight Ltd, Israel). Participants were treated with a maximum of 10 treatments unless 100% repigmentation of stretch was achieved prior to the tenth treatment. Biopsies were taken from willing participants at baseline, immediately after the final treatment and 12 weeks after the last treatment. Nine participants completed all treatment visits. After the final treatment, all the participants had >51% repigmentation of the treated striae. At the 4-week follow-up visit, 67% of participants had greater than 51% improvement, and 56% had greater than 51% improvement at the 8-week and 12-week follow-ups. Hyperpigmentation of striae was seen in >50% of the participants treated. The pretreatment biopsies were confirmatory of striae. There were no diagnostic light microscopic differences in the 4-week post-treatment biopsy set available in one patient. This high intensity UVB\\UVA1 device is an effective and safe modality for the short-term repigmentation of hypopigmented stretch marks. Additional morphologic studies over time are needed to confirm these clinical findings.

  11. A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Eculizumab in Patients with Guillain-Barré Syndrome (GBS): Protocol of Japanese Eculizumab Trial for GBS (JET-GBS)

    PubMed Central

    Yamaguchi, Nobuko; Sato, Yasunori; Nagashima, Kengo; Katayama, Kanako; Sekiguchi, Yukari; Iwai, Yuta; Amino, Hiroshi; Suichi, Tomoki; Yokota, Takanori; Nishida, Yoichiro; Kohara, Nobuo; Hirata, Koichi; Nishiyama, Kazutoshi; Yabe, Ichiro; Kaida, Ken-Ichi; Suzuki, Norihiro; Nodera, Hiroyuki; Tsuji, Shoji; Koike, Haruki; Kira, Jun-Ichi; Hanaoka, Hideki; Kusunoki, Susumu; Kuwabara, Satoshi

    2016-01-01

    Background Guillain-Barré syndrome (GBS) is an immune-mediated neuropathy that causes acute flaccid paralysis. Immunoglobulin and plasma exchange are established treatments for GBS; however, a substantial number of patients, particularly those with severe disease, have poor recovery and residual deficits. Recent studies suggest that complement activation plays a pivotal role in GBS-associated axonal degeneration, and eculizumab is a humanized monoclonal antibody that specifically binds to complement component 5 and potently inhibits complement activation. Objective This clinical trial aims to evaluate the efficacy and safety of eculizumab, a humanized monoclonal antibody directed against complement component 5, for treatment of GBS. Methods The Japanese Eculizumab Trial for GBS (JET-GBS) is a prospective, multicenter, placebo-controlled, double-blind, randomized phase II study conducted at 13 tertiary neurology centers and is funded by the Japan Agency for Medical Research and Development. A total of 33 GBS patients unable to walk independently within 2 weeks from symptom onset (Hughes functional grade 3-5) were randomized at a 2:1 ratio to receive either intravenous eculizumab (900 mg/day) or placebo once weekly for 4 weeks, followed by 20 weeks of follow-up. The primary endpoint for efficacy is the proportion of patients who regain their ability to walk without aid at 4 weeks after the first dose of the study treatment, while primary safety outcomes are the incidence of adverse events and serious adverse events during the trial. Results Enrollment for the trial began in August 2015. This trial is still ongoing. All participants have been enrolled, and follow-up will be completed in October 2016. Conclusions This study is the first to investigate the efficacy and safety of eculizumab for GBS. In case of a positive result, we will plan a phase III trial to investigate this issue in a larger number of patients. ClinicalTrial UMIN Clinical Trials Registry UMIN

  12. Prospective cohort study to evaluate the efficacy of taxane plus platinum and CPT-11plus platinum regimes and to identify prognostic risk factors in cervical cancer patients

    PubMed Central

    Huang, Kecheng; Li, Xiong; Yang, Ru; Shen, Jian; Chen, Zhilan; Qin, Xiaomin; Wang, Shaoshuai; Jia, Yao; Tang, Fangxu; Zhou, Hang; Sun, Haiying; Zhou, Jin; Guo, Lili; Wang, Lin; Qiao, Long; Xiong, Jiaqiang; Wang, Congyi; Ma, Ding; Li, Shuang; Hu, Ting; Wang, Shixuan

    2015-01-01

    Objective: This study was designed to evaluate the response, toxicity and survival of taxanes plus platinum (TP) and CPT-11plus platinum (CP) as neoadjuvant chemotherapies with previously untreated cervical cancer, and to identify prognostic risk factors in these patients. Methods: A cohort study was performed to evaluate the result of TP and CP regimes in the treatment of cervical cancer patients. Results: The study included 567 patients with locally advanced cervical cancer (LACC) staged as FIGO IB-IIB in our clinical departments. Clinical response was found in 76.1% and 78% of patients in the TP and CP arms, respectively, and no treatment-related deaths were reported. During the follow-up period, disease-free survival (DFS) and overall survival (OS) for the TP and CP arms were not different (P = 0.384 for DFS, P = 0.800 for OS). The CP regime showed higher survival rate for endophytic growth style (P = 0.013 for DFS, P = 0.027 for OS). The CP regime also showed higher DFS and OS for G2 tumor (P = 0.027 for DFS, P = 0.032 for OS). In multivariate cox’s proportional hazards regression model, the average death rates were much greater in the non-responder group (HR, 2.68), in the older (> 44 years) group (HR, 2.51), and in the FIGO stage II b patients (HR, 2.84). Conclusions: The CP regime showed higher survival rate for endophytic growth style or G2 tumor. Clinical response, age and FIGO stage were independent prognostic risk factors in this study for both DFS and OS. PMID:26628986

  13. Evaluation of the efficacy of an exercise program for pregnant women with low back and pelvic pain: a prospective randomized controlled trial.

    PubMed

    Ozdemir, Serpil; Bebis, Hatice; Ortabag, Tulay; Acikel, Cengizhan

    2015-08-01

    To evaluate the effect of exercise programs on pregnant women with pregnancy-related low back and pelvic pain. Low back and pelvic pain during pregnancy is a major health problem due to its frequent occurrence and such pain can limit pregnant women in many of their daily activities. A randomized trial with a control group (n = 48) and an intervention group (n = 48). Trial registration number NCT02189356. Department of Obstetrics and Gynecology, between December 2011-May 2012, an Education and Research Hospital in Turkey. Based on the intention-to-treat principle, all pregnant women were analysed according to the group they were assigned to, regardless of whether they received the intervention or not. Participants in the intervention group received health counselling and exercised regarding low back and pelvic pain for four weeks. The pregnant women in the control group received usual care, comprised of routine clinical practice for pregnancy-related low back and pelvic pain. According to Mann-Whitney U test analysis results, there was a statistically significant difference between the control and intervention groups' Visual Analogue Scale during relaxation scores and Visual Analogue Scale during activity scores at the end of the study. According to Mann-Whitney U test analysis results, the change in the mean Oswestry Disability Index score for the intervention group and the difference in the mean scores between the two groups was statistically significant. A four-week exercise program including individualized health counselling to relieve low back and pelvic pain improved the functional status in pregnant women. © 2015 John Wiley & Sons Ltd.

  14. A prospective, randomized trial to evaluate the efficacy of clean intermittent catheterization versus triamcinolone ointment and contractubex ointment of catheter following internal urethrotomy: long-term results.

    PubMed

    Ergün, Osman; Güzel, Ahmet; Armağan, Abdullah; Koşar, Alim; Ergün, Ayşe Gül

    2015-06-01

    Our aim was to evaluate clean intermittent catheterization (CIC) results in combination with triamcinolone ointment and contractubex ointment for lubrication of the catheter after optical internal urethrotomy (OIU). Ninety patients who underwent OIU were randomized into three groups. Two weeks after operation, patients were treated with CIC (group A), triamcinolone ointment CIC (group B), and contractubex ointment CIC (group C). Follow-up continued for 24 months after the OIU. Postoperative results were compared between the three groups. There were no significant differences in the baseline characteristics of the patients or the etiology of the urethral stricture between the three groups. The mean preoperative Q max was 4.31 ml/s. The average score of preoperative international prostate symptom score (IPSS) was 23.1 points. In both groups, after treatment, significant improvements in Q max and IPSS were noted at all follow-up period (p < 0.05). But for Q max and IPSS, there were not any significant differences between groups at all follow-up period (p > 0.05). Overall recurrence rate was 28.9 % (26 out of 90 patients) at the end of the study. Recurrence rates were, however, not found to be statistically significant between these three groups (p > 0.05). Our results indicate that the urethral dilation protocol with CIC after first OIU is a safe, simple, well-tolerated, office-based procedure. Triamcinolone or contractubex ointments of the CIC do not provide an additional benefit. Currently, urethral dilation with CIC after first OIU seems to be the only proven procedure that decreased the recurrence rate.

  15. Efficacy of Eight Months of Nightly Zolpidem: A Prospective Placebo-Controlled Study

    PubMed Central

    Randall, Surilla; Roehrs, Timothy A.; Roth, Thomas

    2012-01-01

    Study Objectives: To evaluate the long-term (8 months) efficacy of zolpidem in adults with chronic primary insomnia using polysomnography. Design: Randomized, double-blind, placebo-controlled clinical trial. Setting: Sleep disorders and research center. Participants: Healthy participants (n = 91), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia. Interventions: Nightly zolpidem, 10 mg (5 mg for patients > 60 yrs) or placebo 30 minutes before bedtime for 8 months. Measurements and Results: Polysomnographic sleep parameters and morning subject assessments of sleep on 2 nights in months 1 and 8. Relative to placebo, zolpidem significantly increased overall total sleep time and sleep efficiency, reduced sleep latency and wake after sleep onset when assessed at months 1 and 8. Overall, subjective evaluations of efficacy were not shown among treatment groups. Conclusions: In adults with primary insomnia, nightly zolpidem administration remained efficacious across 8 months of nightly use. Clinical Trial Information: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525. Citation: Randall S; Roehrs TA; Roth T. Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study. SLEEP 2012;35(11):1551-1557. PMID:23115404

  16. Level of Self-Efficacy of Prospective Mathematics Teachers on Competencies for Planning and Organizing Instruction

    ERIC Educational Resources Information Center

    San, Ismail

    2014-01-01

    The purpose of this study was to determine the level of self-efficacy of prospective mathematics teachers (PMTs) on the competency "planning and organizing instruction" that is one of the teacher competencies identified in 2009 by Ministry of Education. The sample of this study consists of 111 total prospective teachers (PTs) study in…

  17. Self-Efficacy Beliefs of Prospective Primary Mathematics Teachers about Mathematical Literacy

    ERIC Educational Resources Information Center

    Yavuz, Gunes; Gunhan, Berna Canturk; Ersoy, Esen; Narli, Serkan

    2013-01-01

    The aim of this study was to examine the self-efficacy beliefs about mathematical literacy among teachers of primary school mathematics and the relationship between the self-efficacy beliefs and attitudes towards mathematics. To that end, a descriptive research study was conducted with 550 prospective teachers studying primary school mathematics…

  18. Self-Efficacy Beliefs of Prospective Primary Mathematics Teachers about Mathematical Literacy

    ERIC Educational Resources Information Center

    Yavuz, Gunes; Gunhan, Berna Canturk; Ersoy, Esen; Narli, Serkan

    2013-01-01

    The aim of this study was to examine the self-efficacy beliefs about mathematical literacy among teachers of primary school mathematics and the relationship between the self-efficacy beliefs and attitudes towards mathematics. To that end, a descriptive research study was conducted with 550 prospective teachers studying primary school mathematics…

  19. Stress, Self-Efficacy, Social Support, and Psychological Distress among Prospective Chinese Teachers in Hong Kong.

    ERIC Educational Resources Information Center

    Chan, David W.

    2002-01-01

    Examines teacher stress, self-efficacy, social support, and psychological distress in a sample of Chinese prospective teachers (n=83) in Hong Kong. Reports that the teachers experienced higher levels of symptoms in somatic problems followed by anxiety and dysphoria. Discusses self-efficacy and social support as protective factors for teacher…

  20. Internet Self-Efficacy Preferences of Internet Based Environments and Achievement of Prospective Teachers

    ERIC Educational Resources Information Center

    Ozyalcin Oskay, Ozge

    2011-01-01

    The aims of this study are to determine prospective chemistry teachers' internet self-efficacy and preferences of constructivist internet-assisted environments and to examine the relationship between their internet self-efficacy and their preferences for constructivist internet-assisted environments, the relationship between their achievement in…

  1. Evaluating ritual efficacy: evidence from the supernatural.

    PubMed

    Legare, Cristine H; Souza, André L

    2012-07-01

    Rituals pose a cognitive paradox: although widely used to treat problems, rituals are causally opaque (i.e., they lack a causal explanation for their effects). How is the efficacy of ritual action evaluated in the absence of causal information? To examine this question using ecologically valid content, three studies (N=162) were conducted in Brazil, a cultural context in which rituals called simpatias are used to treat a great variety of problems ranging from asthma to infidelity. Using content from existing simpatias, experimental simpatias were designed to manipulate the kinds of information that influences perceptions of efficacy. A fourth study (N=68) with identical stimuli was conducted with a US sample to assess the generalizability of the findings across two different cultural contexts. The results provide evidence that information reflecting intuitive causal principles (i.e., repetition of procedures, number of procedural steps) and transcendental influence (i.e., presence of religious icons) affects how people evaluate ritual efficacy.

  2. Evaluating Ritual Efficacy: Evidence from the Supernatural

    ERIC Educational Resources Information Center

    Legare, Cristine H.; Souza, Andre L.

    2012-01-01

    Rituals pose a cognitive paradox: although widely used to treat problems, rituals are causally opaque (i.e., they lack a causal explanation for their effects). How is the efficacy of ritual action evaluated in the absence of causal information? To examine this question using ecologically valid content, three studies (N=162) were conducted in…

  3. Evaluating Ritual Efficacy: Evidence from the Supernatural

    ERIC Educational Resources Information Center

    Legare, Cristine H.; Souza, Andre L.

    2012-01-01

    Rituals pose a cognitive paradox: although widely used to treat problems, rituals are causally opaque (i.e., they lack a causal explanation for their effects). How is the efficacy of ritual action evaluated in the absence of causal information? To examine this question using ecologically valid content, three studies (N=162) were conducted in…

  4. Retrospect and Prospect of Studies of Teacher Efficacy in China

    ERIC Educational Resources Information Center

    He, Ning; Miao, Danmin

    2006-01-01

    Teacher efficacy is a powerful variable in educational and psychological studies. And it aroused much attention and interest from Chinese scholars in the past decade, which led to an accumulation of documents in this field. Following an introduction of efficacy studies in the west, the article reviews the brief history of those in China,…

  5. A Multicenter, Prospective, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared to Pioglitazone 45 mg in Diabetic Dyslipidemia (PRESS V).

    PubMed

    Pai, Vikas; Paneerselvam, A; Mukhopadhyay, Satinath; Bhansali, Anil; Kamath, Dinesh; Shankar, V; Gambhire, Dhiraj; Jani, Rajendrakumar H; Joshi, Shashank; Patel, Pankaj

    2014-01-01

    Dual PPARα/γ can improve both metabolic effects and minimized the side effects caused by either PPARα or PPARγ agonist. The PRESS V study was aimed to evaluate the safety, tolerability, and efficacy of saroglitazar 2 mg and 4 mg capsules (Lipaglyn™; Zydus Code: ZYH1) as compared to high dose pioglitazone in patients with diabetic dyslipidemia. In this 26-week double-blind, parallel arm, phase 3 study patients with hypertriglyceridemia with type 2 diabetes mellitus (BMI > 23 kg/m(2); hypertriglyceridemia: TG > 200 to 400 mg/dL; glycosylated hemoglobin [HbA1c] >7 to 9%) were enrolled from 14 sites in India. After 2 weeks of lifestyle modification, 122 patients were randomized double-blind to 24-week treatment with the study drugs (saroglitazar 2 mg or 4 mg or pioglitazone 45 mg once daily) in a 1:1:1 ratio. The primary end point was change in plasma triglyceride level at week 24. The secondary end points were change in lipid profile and fasting plasma glucose at week 24. Patients who received study medication and had undergone at least 1 postbaseline efficacy evaluation were included in the efficacy analysis. All randomized patients who received at least a single dose were included for safety evaluation. The efficacy analysis included 109 patients (n = 37 in saroglitazar 2 mg; n = 39 in saroglitazar 4 mg; n = 33 in pioglitazone). Saroglitazar 2 mg and 4 mg significantly reduced (P < .001) plasma triglyceride from baseline by 26.4% (absolute change ± SD: -78.2 ± 81.98 mg/dL) and 45% (absolute change ± SD -115.4 ± 68.11 mg/dL), respectively, as compared to pioglitazone -15.5% (absolute change ± SD: -33.3 ± 162.41 mg/dL) at week 24. Saroglitazar 4 mg treatment also demonstrated marked decrease in low-density lipoprotein (5%), very-low-density lipoprotein (45.5%), total cholesterol (7.7%), and apolipoprotein-B (10.9%). Saroglitazar treatment was generally safe and well tolerated. No serious adverse events were reported in saroglitazar treatment arm and no

  6. Evaluation of efficacy of transcatheter arterial chemoembolization combined with computed tomography-guided radiofrequency ablation for hepatocellular carcinoma using magnetic resonance diffusion weighted imaging and computed tomography perfusion imaging: A prospective study.

    PubMed

    Shao, Guo-Liang; Zheng, Jia-Ping; Guo, Li-Wen; Chen, Yu-Tang; Zeng, Hui; Yao, Zheng

    2017-01-01

    The purpose of this study is to evaluate the efficacy of transcatheter arterial chemoembolization (TACE) combined with computed tomography-guided radiofrequency ablation (CT-RFA) in the treatment of hepatocellular carcinoma (HCC) using magnetic resonance diffusion weighted imaging (MR-DWI) and CT perfusion imaging (CT-PI). From January 2008 to January 2014, a total of 522 HCC patients receiving TACE combined with CT-RFA were included in this study. All patients underwent TACE followed by CT-RFA, and 1 day before treatment and 1 month after treatment they received MR-DWI and CT-PI. Enzyme-linked immunosorbent assay (ELISA) was performed to detect the concentration of alpha-fetoprotein (AFP). Tumor response was evaluated using the revised RECIST criteria. One-year follow-up was conducted on all patients. Receiver-operating characteristic (ROC) curve was drawn to evaluate the efficacy of TACE combined with CT-RFA for HCC using MR-DWI and CT-PI. Total effective rate (complete remission [CR] + partial remission [PR]) of TACE combined with CT-RFA for HCC was 82.95%. HCC patients of CR + PR had lower hepatic blood flow (HBF), hepatic blood volume (HBV), permeability surface (PS), hepatic arterial perfusion (HAP), and hepatic perfusion index (HPI) levels than those of SD + PD, but HCC patients of CR + PR had higher mean transit time (MTT) level than those of SD + PD. The patients of PR + CR had higher apparent diffusion coefficient (ADC) values than those of SD + PD. The patients of PR + CR showed lower AFP concentration than those of SD + PD. ROC curve analysis indicated that the area under the curve (AUC) of AFP, HBV, PS, HAP, HPI, and ADC was more than 0.7, but the AUC of HBF, MTT, and PVP were less than 0.7. After treatment, the AFP, HBF, HBV, PS, HAP, and HPI in the HCC patients with recurrence were higher than those in the HCC patients without, but MTT and ADC in the HCC patients with recurrence were lower than those in the HCC

  7. A prospective, multicenter evaluation of ablating complex fractionated electrograms (CFEs) during atrial fibrillation (AF) identified by an automated mapping algorithm: acute effects on AF and efficacy as an adjuvant strategy.

    PubMed

    Verma, Atul; Novak, Paul; Macle, Laurent; Whaley, Bonnie; Beardsall, Marianne; Wulffhart, Zaev; Khaykin, Yaariv

    2008-02-01

    Complex fractionated electrograms (CFEs) are continuous electrograms (EGMs) of very short cycle length (CL) representing substrate for atrial fibrillation (AF) perpetuation. Ablation of CFEs may result in AF slowing, termination, and prevention, but identifying them can be subjective. The purpose of this study was to prospectively assess (1) whether an automated algorithm can identify CFE regions, (2) the acute effects of ablating these regions on AF, and (3) the long-term efficacy as an adjuvant strategy to pulmonary vein antrum isolation (PVAI). Thirty-five patients (three centers, 61 +/- 9 years, left atrium [LA] 43 +/- 9 mm, ejection fraction 53% +/- 7%) with symptomatic paroxysmal (n = 21) or persistent (n = 14) AF were studied. A decapolar lasso (2-mm spacing) was used for mapping. A three-dimensional shell of the LA and pulmonary veins (PVs) was created. If not already in AF, AF was induced by burst pacing (with or without isoproterenol). Atrial EGMs during AF were mapped/analyzed using an automated CFE algorithm. The algorithm measures the time between discrete deflections in a local EGM over 5 seconds (based on selectable width and peak-to-peak [>0.03 mV] criteria). The mean CL of the local EGM is projected onto the LA shell as a color-coded display. Regions of CL <120 ms (published criteria) were targeted for ablation/elimination. Atrial fibrillation cycle length (AFCL) and regularity were measured from the CS. After CFE ablation, further ablation was done to achieve complete PVAI. AF was spontaneous (n = 20) or induced (n = 15) in all patients. CFEs were most commonly found along the septum (97%), anterior LA (97%), PV antra (83%), base of appendage (83%), and annulus (71%). CFE ablation alone prolonged the AFCL (171 +/- 27 vs. 304 +/- 41 ms; P = .03) and regularized AF to left/right flutter (AFL) in 74% of patients. CFE ablation terminated AF/AFL in 19 patients (54%)-the other 16 were cardioverted-and AF became noninducible in 77%. CFE ablation alone

  8. Prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower gastrointestinal endoscopy.

    PubMed

    Kashiwagi, Kazuhiro; Hosoe, Naoki; Takahashi, Keiji; Nishino, Haruo; Miyachi, Hideyuki; Kudo, Shin-Ei; Martin, James F; Ogata, Haruhiko

    2016-09-01

    No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist-led teams (GLT) using computer-assisted personalized sedation (CAPS), during routine gastrointestinal (GI) endoscopy in Japan do not exist. We aimed to demonstrate the safety and efficacy of propofol sedation versus no sedation (PLCB) when propofol is given by ANES or GLT, during routine GI endoscopy. Two hundred and seventy two American Society of Anesthesiologists (ASA) class I or II adults were prospectively enrolled in this multicenter study and randomized into three groups (PLCB, ANES, GLT). Ability to maintain moderate sedation, defined as MOAA/S scores of 2-4 for ≥50% of all MOAA/S measurements from scope-in to scope-out, was the primary endpoint. Secondary endpoints included patient (PSSI) and clinician (CSSI) satisfaction. Proportion of subjects maintained in moderate sedation by ANES (88.1%) and GLT (94.5%) was significantly higher than PLCB (21.6%; P < 0.001); there was no difference between the ANES and GLT groups (P = 0.116). Mean PSSI scores for subjects sedated by ANES (81.2 ± 12.5) and GLT (80.8 ± 14.1) were significantly higher than PLCB (65.3 ± 19.7; P < 0.001) and mean CSSI scores were also significantly higher in both active treatment groups (75.5 ± 10.2, 77.9 ± 10.3) than PLCB (60.8 ± 18.6; P < 0.001). Moderate sedation can be achieved and maintained with propofol, improving both patient and physician satisfaction, when propofol is given by an anesthesiologist or a gastroenterologist-led team using CAPS. © 2016 Japan Gastroenterological Endoscopy Society.

  9. Clinical and angiographic outcomes after treatment of de novo coronary stenoses with a novel platinum chromium thin-strut stent: primary results of the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) trial.

    PubMed

    Kereiakes, Dean J; Cannon, Louis A; Feldman, Robert L; Popma, Jeffrey J; Magorien, Raymond; Whitbourn, Robert; Dauber, Ira M; Rabinowitz, Abram C; Ball, Michael W; Bertolet, Barry; Kabour, Ameer; Foster, Michael C; Wang, John C; Underwood, Paul; Dawkins, Keith D

    2010-07-20

    The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses. The TAXUS Element is a novel thin-strut (81 microm), platinum chromium alloy PES designed to improve radial strength, radiopacity, and deliverability, while safely providing comparable restenosis benefit compared with a previous-generation PES. The PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) Workhorse (WH) trial is a prospective, randomized (3:1), controlled, multicenter study of the TAXUS Element (vs. TAXUS Express) PES for the treatment of de novo coronary atherosclerotic lesionsor=2.75 to efficacy to the TAXUS Express PES. Furthermore, no safety concerns related to the novel platinum

  10. Efficacy and safety of polyacrylamide hydrogel for facial soft-tissue augmentation in a 2-year follow-up: a prospective multicenter study for evaluation of safety and aesthetic results in 101 patients.

    PubMed

    von Buelow, Silvester; Pallua, Norbert

    2006-09-01

    Polyacrylamide (Aquamid) is a nonabsorbable soft-tissue filler. It consists of a polyacrylamide hydrogel. Safety and aesthetic results after injection of polyacrylamide hydrogel for facial soft-tissue enhancement were analyzed in a clinical trial. In a prospective multicenter study, 251 patients were enrolled for injection of polyacrylamide hydrogel (Aquamid). The results of the first year follow-up have been described previously. One hundred one of 251 initially enrolled patients could be recruited for follow-up 24 months after the first injection. Standardized photographs were taken, and blood and urine samples were collected before treatment and during follow-up visits. Common sites of injection were nasolabial folds, lips, glabella folds, and other sites. The amount of injected gel ranged from 0.2 to 12 ml. A course of 24 months was followed in 101 patients. Results were judged to be good or very good by the investigators in 93 patients. Eighty-six patients judged the aesthetic outcome as satisfactory or very satisfactory. No severe side effects were observed during the 2-year follow-up period. Transient local reactions that resolved spontaneously were detected in several patients. In one case, burning sensations after lip augmentation were reported lasting up to the 24-month follow-up visit. Polyacrylamide hydrogel (Aquamid) yielded satisfying aesthetic results in more than 90 percent of patients. There was no difference in efficacy between 12 and 24 months' follow-up. No adverse soft-tissue reaction was observed. The study group may be biased, as patients with bad results may have refrained from further follow-up. Long-term follow-up is necessary.

  11. [Immunological surrogate endpoints to evaluate vaccine efficacy].

    PubMed

    Jin, Pengfei; Li, Jingxin; Zhou, Yang; Zhu, Fengcai

    2015-12-01

    An immunological surrogate endpoints is a vaccine-induced immune response (either humoral or cellular immune) that predicts protection against clinical endpoints (infection or disease), and can be used to evaluate vaccine efficacy in clinical vaccine trials. Compared with field efficacy trials observing clinical endpoints, immunological vaccine trials could reduce the sample size or shorten the duration of a trial, which promote the license and development of new candidate vaccines. For these reasons, establishing immunological surrogate endpoints is one of 14 Grand Challenges of Global Health of the National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation. From two parts of definition and statistical methods for evaluation of surrogate endpoints, this review provides a more comprehensive description.

  12. A Prospective Evaluation of Helical Tomotherapy

    SciTech Connect

    Bauman, Glenn ||. E-mail: glenn.bauman@lhsc.on.ca; Yartsev, Slav; Rodrigues, George ||; Lewis, Craig; Hammond, Alex; Perera, Francisco; Ash, Robert, Dar, A. Rashid |; Venkatesan, Varagur M. |; Yu, Edward; Lock, Michael; Battista, Jerry; Van Dyk, Jake ||; Baily, Laura; Coad, Terry C; Trenka, Kris C.; Warr, Barbara; Kron, Tomas

    2007-06-01

    Purpose: To report results from two clinical trials evaluating helical tomotherapy (HT). Methods and Materials: Patients were enrolled in one of two prospective trials of HT (one for palliative and one for radical treatment). Both an HT plan and a companion three-dimensional conformal radiotherapy (3D-CRT) plan were generated. Pretreatment megavoltage computed tomography was used for daily image guidance. Results: From September 2004 to January 2006, a total of 61 sites in 60 patients were treated. In all but one case, a clinically acceptable tomotherapy plan for treatment was generated. Helical tomotherapy plans were subjectively equivalent or superior to 3D-CRT in 95% of plans. Helical tomotherapy was deemed equivalent or superior in two thirds of dose-volume point comparisons. In cases of inferiority, differences were either clinically insignificant and/or reflected deliberate tradeoffs to optimize the HT plan. Overall imaging and treatment time (median) was 27 min (range, 16-91 min). According to a patient questionnaire, 78% of patients were satisfied to very satisfied with the treatment process. Conclusions: Helical tomotherapy demonstrated clear advantages over conventional 3D-CRT in this diverse patient group. The prospective trials were helpful in deploying this technology in a busy clinical setting.

  13. Quantitative framework for prospective motion correction evaluation.

    PubMed

    Pannetier, Nicolas A; Stavrinos, Theano; Ng, Peter; Herbst, Michael; Zaitsev, Maxim; Young, Karl; Matson, Gerald; Schuff, Norbert

    2016-02-01

    Establishing a framework to evaluate performances of prospective motion correction (PMC) MRI considering motion variability between MRI scans. A framework was developed to obtain quantitative comparisons between different motion correction setups, considering that varying intrinsic motion patterns between acquisitions can induce bias. Intrinsic motion was considered by replaying in a phantom experiment the recorded motion trajectories from subjects. T1-weighted MRI on five volunteers and two different marker fixations (mouth guard and nose bridge fixations) were used to test the framework. Two metrics were investigated to quantify the improvement of the image quality with PMC. Motion patterns vary between subjects as well as between repeated scans within a subject. This variability can be approximated by replaying the motion in a distinct phantom experiment and used as a covariate in models comparing motion corrections. We show that considering the intrinsic motion alters the statistical significance in comparing marker fixations. As an example, two marker fixations, a mouth guard and a nose bridge, were evaluated in terms of their effectiveness for PMC. A mouth guard achieved better PMC performance. Intrinsic motion patterns can bias comparisons between PMC configurations and must be considered for robust evaluations. A framework for evaluating intrinsic motion patterns in PMC is presented. © 2015 Wiley Periodicals, Inc.

  14. Quantitative framework for prospective motion correction evaluation

    PubMed Central

    Pannetier, Nicolas; Stavrinos, Theano; Ng, Peter; Herbst, Michael; Zaitsev, Maxim; Young, Karl; Matson, Gerald; Schuff, Norbert

    2014-01-01

    Purpose Establishing a framework to evaluate performances of prospective motion correction (PMC) MRI considering motion variability between MRI scans. Method A framework was developed to obtain quantitative comparisons between different motion correction setups, considering that varying intrinsic motion patterns between acquisitions can induce bias. Intrinsic motion was considered by replaying in a phantom experiment the recorded motion trajectories from subjects. T1-weighted MRI on five volunteers and two different marker fixations (mouth guard and nose bridge fixations) were used to test the framework. Two metrics were investigated to quantify the improvement of the image quality with PMC. Results Motion patterns vary between subjects as well as between repeated scans within a subject. This variability can be approximated by replaying the motion in a distinct phantom experiment and used as a covariate in models comparing motion corrections. We show that considering the intrinsic motion alters the statistical significance in comparing marker fixations. As an example, two marker fixations, a mouth guard and a nose bridge, were evaluated in terms of their effectiveness for PMC. A mouth guard achieved better PMC performance. Conclusion Intrinsic motion patterns can bias comparisons between PMC configurations and must be considered for robust evaluations. A framework for evaluating intrinsic motion patterns in PMC is presented. PMID:25761550

  15. Multicenter prospective evaluation of dogs with trauma.

    PubMed

    Hall, Kelly E; Holowaychuk, Marie K; Sharp, Claire R; Reineke, Erica

    2014-02-01

    To determine hospital admission variables for dogs with trauma including values determined with scoring systems (animal trauma triage [ATT], modified Glasgow coma scale [MGCS], and acute patient physiologic and laboratory evaluation [APPLE] scores) and the usefulness of such variables for the prediction of outcome (death vs survival to hospital discharge). Prospective, multicenter, cohort study. 315 client-owned dogs. By use of a Web-based data capture system, trained personnel prospectively recorded admission ATT, MGCS, and APPLE scores; clinical and laboratory data; and outcome (death vs survival to discharge) for dogs with trauma at 4 veterinary teaching hospitals during an 8-week period. Cause of injury was most commonly blunt trauma (173/315 [54.9%]) followed by penetrating trauma (107/315 [34.0%]), or was unknown (35/315 [11.1%]). Of the 315 dogs, 285 (90.5%) survived to hospital discharge. When 16 dogs euthanized because of cost were excluded, dogs with blunt trauma were more likely to survive, compared with dogs with penetrating trauma (OR, 8.5). The ATT (OR, 2.0) and MGCS (OR, 0.47) scores and blood lactate concentration (OR, 1.5) at the time of hospital admission were predictive of outcome. Surgical procedures were performed for 157 (49.8%) dogs; surgery was associated with survival to discharge (OR, 7.1). Results indicated ATT and MGCS scores were useful for prediction of outcome for dogs evaluated because of trauma. Penetrating trauma, low blood lactate concentration, and performance of surgical procedures were predictive of survival to hospital discharge. The methods enabled collection of data for a large number of dogs in a short time.

  16. Efficacy of transforaminal versus interspinous corticosteroid injectionin discal radiculalgia - a prospective, randomised, double-blind study.

    PubMed

    Thomas, E; Cyteval, C; Abiad, L; Picot, M C; Taourel, P; Blotman, F

    2003-10-01

    A prospective, randomised, double-blind study was carried out to compare the respective efficacies of transforaminal and interspinous epidural corticosteroid injections in discal radiculalgia. Thirty-one patients (18 females, 13 males) with discal radicular pain of less than 3 months' duration were consecutively randomised to receive either radio-guided transforaminal or blindly performed interspinous epidural corticosteroid injections. Post-treatment outcome was evaluated clinically at 6 and 30 days, and then at 6 months, but only by mailed questionnaire. At day 6, the between-group difference was significantly in favour of the transforaminal group with respect to Schober's index, finger-to-floor distance, daily activities, and work and leisure activities on the Dallas pain scale. At day 30, pain relief was significantly better in the transforaminal group. At month 6, answers to the mailed questionnaire still showed significantly better results for transforaminal injection concerning pain, daily activities, work and leisure activities and anxiety and depression, with a decline in the Roland-Morris score. In recent discal radiculalgia, the efficacy of radio-guided transforaminal epidural corticosteroid injections was higher than that obtained with blindly-performed interspinous injections.

  17. Prospective safety performance evaluation on construction sites.

    PubMed

    Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

    2015-05-01

    This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Prospectively Predicting Dietary Restraint: The Role of Interpersonal Self-Efficacy, Weight/Shape Self-Efficacy, and Interpersonal Stress

    PubMed Central

    Cain, A.S.; Bardone-Cone, A.M.; Abramson, L.Y.; Vohs, K.D.; Joiner, T.E.

    2009-01-01

    Objective This study investigated how the precursors of interpersonal self-efficacy and weight/shape self-efficacy would interact in the face of interpersonal stress to prospectively predict dietary restraint. Three models were explored, each with a different type of interpersonal stress: stress from same sex friendships, opposite sex friendships, or romantic relationships. Method At Time 1 (T1), participants (N = 406) reported on their typical levels of interpersonal self-efficacy and weight/shape self-efficacy, and recent (past 28 days) dietary restraint. At Time 2 (T2), 11 weeks after T1, participants reported on their recent (past 28 days) levels of dietary restraint at that time. Between T1 and T2, participants completed inventories weekly on the previous week’s interpersonal stressors. Results Consistent with prediction, low interpersonal self-efficacy and high weight/shape self-efficacy combined with high interpersonal stress (whether from same sex friendships, opposite sex friendships, or romantic relationships) to predict the highest levels of T2 dietary restraint after controlling for T1 levels. Conclusion These results further link the interpersonal domain with dietary restraint and elucidate characteristics of women particularly apt to increase dietary restraint in response to interpersonal stress. PMID:19718670

  19. Prospective Primary Teachers' Self-Efficacy and Emotions in Science Teaching

    ERIC Educational Resources Information Center

    Brigido, Maria; Borrachero, Ana Belen; Bermejo, Maria Luisa; Mellado, Vicente

    2013-01-01

    The self-efficacy of prospective primary teachers was studied, considering in particular the relationship of that construct with the emotions they expect to experience as future science teachers, differentiating between when they will be teaching the content of the "nature sciences" (biology and geology) and that of the "hard…

  20. Prospective Primary Teachers' Self-Efficacy and Emotions in Science Teaching

    ERIC Educational Resources Information Center

    Brigido, Maria; Borrachero, Ana Belen; Bermejo, Maria Luisa; Mellado, Vicente

    2013-01-01

    The self-efficacy of prospective primary teachers was studied, considering in particular the relationship of that construct with the emotions they expect to experience as future science teachers, differentiating between when they will be teaching the content of the "nature sciences" (biology and geology) and that of the "hard…

  1. Prospective Teachers' Lifelong Learning Tendencies and Information Literacy Self-Efficacy

    ERIC Educational Resources Information Center

    Demirel, Melek; Akkoyunlu, Buket

    2017-01-01

    The purpose of this study is to determine the correlations between prospective teachers' lifelong learning tendencies and their information literacy self-efficacy. It is also to find out if such properties differed significantly in terms of gender, grade, computer usage skills, achievement perception, and willingness to pursue an academic career…

  2. Relationship of Self-Efficacy and Teacher Knowledge for Prospective Elementary Education Teachers

    ERIC Educational Resources Information Center

    Sharp, Ann C.; Brandt, Lorilynn; Tuft, Elaine A.; Jay, Sandy

    2016-01-01

    This research investigates relationships between prospective teachers' self-efficacy of literacy instruction and their growing knowledge of literacy essentials. An instrument was used that is one part self-ratings of confidence levels in teaching specific literacy skills and one part assessment of literacy knowledge required to teach those skills.…

  3. Analysis of Social Problem Solving and Social Self-Efficacy in Prospective Teachers

    ERIC Educational Resources Information Center

    Erozkan, Atilgan

    2014-01-01

    The purpose of this study is to investigate the relationship between social problem solving and social selfefficacy and the predictive role of social problem solving skills with social self-efficacy. The sample consists of 706 prospective teachers (362 female and 344 male) who are majoring in different fields at Mugla Sitki Kocman University's…

  4. Safety and efficacy comparison of minocycline microgranules vs lymecycline in the treatment of mild to moderate acne: randomized, evaluator-blinded, parallel, and prospective clinical trial for 8 weeks.

    PubMed

    Ocampo-Candiani, Jorge; Velazquez-Arenas, Luis Leobardo; de la Fuente-Garcia, Alberto; Trevino-Gomezharper, Carlos; Berber, Arturo

    2014-06-01

    Minocycline and lymecycline are used in the treatment of acne, but there is not enough evidence to support superior efficacy of one of them. 170 participants from 14 to 34 years old with mild to moderate facial acne vulgaris were recruited. 84 had 100 mg of minocycline in a single daily dose for 8 weeks and 86 had 300 mg of lymecycline in a single daily dose for 8 weeks. Participants were evaluated at baseline, week 4 and week 8. 65 minocycline and 60 lymecycline patients were evaluable. The last observation carried forward for the count of non-inflammatory lesions changed from 37.5 ± 17.8 to 37.7 ± 17.8 in the minocycline group and from 36.9 ± 15.5 to 33.4 ± 19.3 in the lymecycline group (no significant changes); corresponding changes in inflammatory lesions were from 19.4 ± 12.4 to 12.2 ± 10.0 in the minocycline group and from 20.1 ± 11.3 to 12.6 ± 8.4 in lymecycline group (P< 0.05 comparing baseline vs. final in both groups). Porphyrin counts varied from 899.5 ± 613.9 to 233.5 ± 219.5 in the minocycline group and from 956.9 ± 661.8 to 411.8 ± 411.5 in the lymecycline group (P<0.05 between the groups at study end). 36 (42.9%) patients receiving minocycline suffered 55 adverse events (22 of them gastrointestinal), while 28 (33.3%) lymecycline patients had 37 adverse events (15 of them gastrointestinal). One patient in the lymecycline group withdrew the study due to gastritis, and one more patient in the same group experienced eosinophilia. There were no differences between the groups in non-inflammatory and inflammatory lesion counts, and in the safety profile. Treatment with minocycline induced statistically significant decrease in facial porphyrin counts compared to the group treated with lymecycline (ClinicalTrials.gov number, NCT00988026).

  5. Comparative Study for Efficacy and Safety of Adenoidectomy according to the Surgical Method: A Prospective Multicenter Study

    PubMed Central

    Lee, Woo Hyun; Kim, Dong-Kyu; Kim, Sung Wan; Kim, Young Hyo; Nam, Jung Gwon; Park, Seok-Won; Park, Chan-Soon; Bae, Woo Yong; Yeo, Nam-Kyung; Won, Tae-Bin; Lee, Seung Hoon; Lee, Tae-Hoon; Lee, Hyoung Joo; Kim, Sang-Wook; Jeong, Sung-Wook; Choi, Jeong-Seok; Han, Doo Hee; Choi, Ji Ho

    2015-01-01

    Background/Objective There have been several operative techniques for adenoidectomy and their efficacy and morbidity are different according to the technique. This prospective multicenter study was aimed to compare the efficacy and morbidity of coblation adenoidectomy (CA) with those of power-assisted adenoidectomy. Study Design Prospective multi-institutional study. Methods Children who underwent CA, power-assisted adenoidectomy with cauterization (PAA+C) or without cauterization (PAA-C) due to adenoid hypertrophy were enrolled from 13 hospitals between July 2013 and June 2014. Mean operation time, degree of intraoperative bleeding and postoperative bleeding rate were evaluated. Results A total of 388 children (mean age ± standard deviation = 6.6 ± 2.5 years; 245 males and 143 females) were included. According to the adenoidectomy technique, the children were classified into 3 groups: (1) CA (n = 116); (2) PAA+C (n = 153); and (3) PAA-C (n = 119). Significant differences were not found in age and sex among three groups. In the CA group, mean operation time was significantly shorter (P < 0.001) and degree of intraoperative bleeding was significantly less (P < 0.001) compared to PAA+C or PAA-C group. Delayed postoperative bleeding rate of PAA-C group was significantly higher than that of CA or PAA+C group (P = 0.016). Conclusions This prospective multicenter study showed that CA was superior to PAA in terms of mean operation time and degree of intraoperative bleeding. PMID:26267337

  6. Feasibility, Efficacy, and Predictive Factors for the Technical Success of Endoscopic Nasogallbladder Drainage: A Prospective Study

    PubMed Central

    Yane, Kei; Maguchi, Hiroyuki; Katanuma, Akio; Takahashi, Kuniyuki; Osanai, Manabu; Kin, Toshifumi; Takaki, Ryo; Matsumoto, Kazuyuki; Gon, Katsushige; Matsumori, Tomoaki; Tomonari, Akiko; Nojima, Masanori

    2015-01-01

    Background/Aims Several studies have shown the usefulness of endoscopic nasogallbladder drainage (ENGBD) in patients with acute cholecystitis. However, the procedure is difficult, and factors that affect technical success have not yet been clarified. We conducted a prospective study to evaluate the technical feasibility, efficacy, and predictive factors for the technical success of ENGBD in patients with acute cholecystitis. Methods All patients with moderate or severe acute cholecystitis who were enrolled underwent ENGBD between April 2009 and April 2011. Patients with surgically altered anatomy or pancreatobiliary malignancies were excluded. The primary outcomes included technical success, clinical success, and complications. Factors that could affect the technical success were also examined. Results Of the 27 patients who underwent ENGBD during the study period, technical success was achieved in 21 (78%) and clinical improvement was achieved in 20 (95%). Early complications were encountered in four patients (15%). Gallbladder wall thickness (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.08 to 2.47) and age (OR, 1.16; 95% CI, 1.00 to 1.35) were effective predictors of technical failure. Conclusions ENGBD was effective in resolving acute cholecystitis; however, this modality was technically challenging and had a limited success rate. Because of technical difficulties, ENGBD should be reserved for limited indications. PMID:25287172

  7. Feasibility, efficacy, and predictive factors for the technical success of endoscopic nasogallbladder drainage: a prospective study.

    PubMed

    Yane, Kei; Maguchi, Hiroyuki; Katanuma, Akio; Takahashi, Kuniyuki; Osanai, Manabu; Kin, Toshifumi; Takaki, Ryo; Matsumoto, Kazuyuki; Gon, Katsushige; Matsumori, Tomoaki; Tomonari, Akiko; Nojima, Masanori

    2015-03-01

    Several studies have shown the useful-ness of endoscopic nasogallbladder drainage (ENGBD) in patients with acute cholecystitis. However, the procedure is difficult, and factors that affect technical success have not yet been clarified. We conducted a prospective study to eval-uate the technical feasibility, efficacy, and predictive factors for the technical success of ENGBD in patients with acute cholecystitis. All patients with moderate or severe acute cholecystitis who were enrolled underwent ENGBD between April 2009 and April 2011. Patients with surgically altered anatomy or pancreatobiliary malignancies were ex-cluded. The primary outcomes included technical success, clinical success, and complications. Factors that could affect the technical success were also examined. Of the 27 patients who underwent ENGBD during the study period, technical success was achieved in 21 (78%) and clinical improvement was achieved in 20 (95%). Early complications were encountered in four patients (15%). Gallbladder wall thickness (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.08 to 2.47) and age (OR, 1.16; 95% CI, 1.00 to 1.35) were effective predictors of technical failure. ENGBD was effective in resolving acute cholecystitis; however, this modality was technically challenging and had a limited suc-cess rate. Because of technical difficulties, ENGBD should be reserved for limited indications. (Gut Liver, 2015;9239-246).

  8. Contribution of Geophysical Prospecting to Geohazard Evaluation

    SciTech Connect

    Nicolich, Rinaldo

    2006-03-23

    The physical properties of the subsoil are studied using geophysical methods. These studies are always indirect, such as gravimetric, magnetometric, magnetotelluric or reflection-refraction seismic surveys and are often combined to obtain more accurate and reliable results. With these tools the oil industry commonly investigates the sedimentary basins to localize structures that may favor the accumulation of hydrocarbons. Above all, seismic prospecting allow the understanding of the underground geology, defining boundaries of the geological formations as well as mechanical and physical properties of the rocks. New cutting-edge techniques allow high quality data to be obtained in almost all geological contexts and make reflection seismic the most powerful tool in subsurface observations. The seismic method was utilized in geothermal resources investigation, research of water strategic resources, volcanic risks assessment, etc. The refraction method was the first to be used in the exploration of oil reservoirs. At present the industry employs mainly refraction seismics to study shallow formations. Conversely, university researchers have applied wide-angle reflection-refraction surveys to localize deep crustal interfaces analyzing the high amplitudes of the wide-angle reflections and the velocities obtained from the refracted signals. Moho discontinuity and velocity distribution within the crust were mapped out, indicating thickness and boundary conditions in different geological settings. The maps have been used in the analysis of geodynamical behavior and of active movements within the crust, useful for seismotectonic investigations. The further addition of the seismic reflection imaging, with deep penetration and long transects, completed multidisciplinary programs to unravel the structure of the crust with clear seismic images and models. High-resolution application of seismic has a central role in the identification and characterization of seismotectonic and

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

    PubMed

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

    2016-03-01

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

  10. Evaluation of electrode polarity on defibrillation efficacy.

    PubMed

    Bardy, G H; Ivey, T D; Allen, M D; Johnson, G; Greene, H L

    1989-02-15

    The effect of electrode polarity on defibrillation thresholds in humans is unknown. This prospective, randomized evaluation of electrode polarity on defibrillation thresholds was performed in 21 survivors of ventricular fibrillation (VF) undergoing cardiac surgery. Defibrillation was always performed with 2 identical large rectangular, wire mesh electrodes positioned over the anterior wall of the right ventricle and the posterolateral wall of the left ventricle. The initial electrode polarity for the left ventricular (LV) electrode was chosen randomly for determination of the defibrillation threshold. Subsequently, electrode polarity was reversed. The defibrillation threshold was defined as the lowest pulse amplitude that would effectively terminate VF with a single discharge delivered 10 seconds after initiation of an episode of VF with alternating current. For each defibrillation pulse, voltage, current, resistance and delivered energy were recorded. Of the 21 patients, 15 (71%) had a lower defibrillation threshold when the LV electrode was positive, 2 patients (10%) had a lower defibrillation threshold when the LV electrode was negative and 4 patients (19%) had equal defibrillation thresholds (within 0.5 J) regardless of polarity. The mean leading edge defibrillation threshold voltage was 370 +/- 88 volts when the LV electrode was negative and 320 +/- 109 volts (14% less) when the LV electrode was positive (p = 0.014). Mean leading edge defibrillation threshold current was 9.3 +/- 3.1 amps when the LV electrode was negative compared to 7.7 +/- 3.1 amps (17% less) when the LV electrode was positive (p = 0.0033). There were no differences in resistance with the 2 configurations.(ABSTRACT TRUNCATED AT 250 WORDS)

  11. An Open Label, Randomized, Comparative, Parallel Group, Multicenter, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of “AHPL/AYTOP/0113” in Comparison with “Framycetin Sulphate Cream” in Acute Wounds

    PubMed Central

    Nipanikar, Sanjay U; Gajare, Kamalakar V; Vaidya, Vidyadhar G; Kamthe, Amol B; Upasani, Sachin A; Kumbhar, Vidyadhar S

    2017-01-01

    Objectives: The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds. Methodology: It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream) and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream). All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier). All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. Results: Group-A subjects took significantly less (P < 0.05) i.e., (mean) 7.77 days than (mean) 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better (P < 0.05) results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. Excellent overall efficacy and tolerability was observed in subjects of both the groups. No adverse event or adverse drug reaction was noted in any subject of both the groups. Conclusion: AHPL/AYTOP/0113 cream proved to be superior to Framycetin sulphate cream in healing of acute wounds. PMID:28867855

  12. The Relationship between Attitudes of Prospective Physical Education Teachers towards Education Technologies and Computer Self-Efficacy Beliefs

    ERIC Educational Resources Information Center

    Kalemoglu Varol, Yaprak

    2014-01-01

    The aim of research is to investigate the relationship between attitudes of prospective physical education teacher towards education technologies and their computer self-efficacy beliefs. Relational research method has been used in the study. Study group consists of 337 prospective physical education teachers ("M"[subscript age] = 21.57…

  13. Rufinamide efficacy and safety as adjunctive treatment in children with focal drug resistant epilepsy: the first Italian prospective study.

    PubMed

    Moavero, Romina; Cusmai, Raffaella; Specchio, Nicola; Fusco, Lucia; Capuano, Alessandro; Curatolo, Paolo; Vigevano, Federico

    2012-11-01

    Rufinamide is a new antiepileptic drug approved as add-on treatment in Lennox-Gastaut syndrome from the age of 4 years, and for the treatment of focal seizures in adults and adolescents. The aim of this prospective study was to evaluate the safety and efficacy of add-on Rufinamide in the treatment of childhood focal drug resistant epilepsy. We recruited 70 patients for a prospective, add-on, open-label study. Inclusion criteria were: 3 years of age or more; focal drug resistant epilepsy despite the use of three previous AEDs; use of at least one other AED, but no more than three at baseline; more than one seizure per month in the previous 6 months. Rufinamide efficacy was observed up to 12 months of follow-up, with a total responder rate of 38.57%. We found the best results in focal epilepsies due to structural/metabolic etiology (42.6%). The responder rate was similar for focal seizures with secondary generalization, simple focal seizures other than myoclonic jerks, and complex partial seizures. Response to Rufinamide was not related to the age. Our experience suggests that Rufinamide can be effective in reducing focal seizure frequency in children with drug resistant epilepsy, and that it can be considered as a safe drug. Copyright © 2012 Elsevier B.V. All rights reserved.

  14. Extended Reverse Sural Artery Flap’s Safety, Success and Efficacy - A Prospective Study

    PubMed Central

    MN, Prakashkumar; M, Shankarappa

    2014-01-01

    Background: One of the challenges in reconstructive surgeries, faced by a majority of surgeons, is the soft tissue defect management around the lower-third of the leg, plantar and dorsal feet. Due to the sensitive location and other related difficulties, only limited options are available in this region. A durable flap is the preferred option for coverage of such defects. Objective: To evaluate the safety, success and efficacy of the extended reverse sural artery flap which was harvested, with extension to proximal-third of the leg. Methodology: This prospective study was conducted at Department of Plastic Surgery, on 18 consecutive patients with soft tissue defects and exposed bones, tendons and joints of distal-third of leg and foot. We harvested medium to large sized reverse sural artery flaps with extensions to the upper third of the calf, to cover the defects found in the distal tibia, ankle, heel, foot, and sole. Results: A majority of flaps provided a good coverage for defects. Two cases developed marginal necrosis of flaps in the distal border, which was treated with use of secondary skin grafts. Four flaps developed venous congestions. In other patients, minor complications such as rupture of suture inset, development of ulcer over insensate flap, since only one patient developed ulcer and another one patient developed inset rupture and graft loss occurred. In 16 cases, the final outcome was unaffected by any complications. Conclusions: Extension of reverse sural artery flap to the proximal third of the leg was safe and reliable and it was efficiently used to treat patients with large and far wounds of distal leg, foot and sole. PMID:24995209

  15. The Science Teaching Self-Efficacy of Prospective Elementary Education Majors Enrolled in Introductory Geology Lab Sections

    ERIC Educational Resources Information Center

    Baldwin, Kathryn A.

    2014-01-01

    This study examined prospective elementary education majors' science teaching self-efficacy while they were enrolled in an introductory geology lab course for elementary education majors. The Science Teaching Efficacy Belief Instrument Form B (STEBI-B) was administered during the first and last lab class sessions. Additionally, students were…

  16. The Science Teaching Self-Efficacy of Prospective Elementary Education Majors Enrolled in Introductory Geology Lab Sections

    ERIC Educational Resources Information Center

    Baldwin, Kathryn A.

    2014-01-01

    This study examined prospective elementary education majors' science teaching self-efficacy while they were enrolled in an introductory geology lab course for elementary education majors. The Science Teaching Efficacy Belief Instrument Form B (STEBI-B) was administered during the first and last lab class sessions. Additionally, students were…

  17. An Investigation into Prospective Science Teachers' Attitudes towards Laboratory Course and Self-Efficacy Beliefs in Laboratory Use

    ERIC Educational Resources Information Center

    Aka, Elvan Ince

    2016-01-01

    The aim of the current study is to identify the attitudes towards the laboratory course and self-efficacy beliefs in the laboratory use of prospective teachers who are attending Gazi University Gazi Education Faculty Primary Education Science Teaching program, and to investigate the relationship between the attitudes and self-efficacy beliefs.…

  18. The Teaching Processes of Prospective Science Teachers with Different Levels of Science-Teaching Self-Efficacy Belief

    ERIC Educational Resources Information Center

    Saka, Mehpare; Bayram, Hale; Kabapinar, Filiz

    2016-01-01

    The concept of self-efficacy, which is an important variable in the teaching process, and how it reflects on teaching have recently been the focus of attention. Therefore, this study deals with the relationship between the science-teaching self-efficacy beliefs of prospective science teachers and their teaching practices. It was conducted with…

  19. Sequential biventricular pacing: evaluation of safety and efficacy.

    PubMed

    Mortensen, Peter T; Sogaard, Peter; Mansour, Hassan; Ponsonaille, Jean; Gras, Daniel; Lazarus, Arnaud; Reiser, Wolfgang; Alonso, Christine; Linde, Cecilia M; Lunati, Maurizio; Kramm, Berthold; Harrison, E Mark

    2004-03-01

    The study evaluated the clinical safety, performance, and efficacy of sequential biventricular pacing in the InSync III (Model 8042) biventricular stimulator in a multicenter, prospective 3-month study and assessed the proper functioning of features aiming at improving biventricular AV therapy delivery. The system was successfully implanted in 189 (95.9%) of 198 patients with symptomatic systolic heart failure and a prolonged QRS complex duration. Patients significantly improved their 6-minute hall walk distance (baseline 339 +/- 92 vs 3-month 422 +/- 127 meter, P < 0.001) and NYHA class (baseline 3.1 +/- 0.5 vs 3-month 1.9 +/- 0.7, P < 0.001). Echocardiographic optimization of sequential biventricular pacing showed an improvement in stroke volume compared to simultaneous stimulation (sequential 68 +/- 24 mL vs simultaneous 56 +/- 23 mL, P < 0.001) at baseline and at 3 months. In 88% (30/34) of the patients these improvements were seen within a small range of V-V delays of +/-20 ms and in 94% (32/34) within V-V delays of +/-40 ms. In contrast, programming beyond this range reduced stroke volume below that during simultaneous biventricular pacing. The device functioned as expected. LV lead dislodgement was observed in 12 patients and phrenic nerve stimulation required lead repositioning in 2 patients. Eight patients died during the study. Patient survival at 3 and 6 months was 97 +/- 2% and 94 +/- 2%, respectively. Cause of death was cardiac (n = 7), heart failure related (n = 3), arrhythmia related (n = 2), and unknown (n = 2). In conclusion, this sequential biventricular pacemaker was safe and efficacious.

  20. Prospective Evaluation of the Safety and Efficacy of a 1060-nm Large Spot Size, Vacuum-Assisted Hair Removal Diode Laser System in Asian/Pacific Fitzpatrick's Skin Types IV-V Patients.

    PubMed

    Tahiliani, Sushil T; Tahiliani, Harsh S

    2016-11-01

    Laser-based photoepilation of dark skin types demands a delicate combination of appropriate light wavelengths and spot size to achieve optimal epidermal-to-follicular energy absorption ratios. This prospective study assessed the axillary, arm, thigh, and back hair clearing ef cacy of the LightSheer In nity 1060 nm diode laser in 10 Fitzpatrick skin type IV-V patients. Each area was treated up to ve times, at 4-6-week intervals, after which immediate skin responses and adverse events were recorded. Hair count, color and coarseness were assessed before each treatment session, as well as 1, 3, and 6 months following the last session. Both patients and the treating physician rated the degree of improvement with time, and patients also ranked their satisfaction with the treatment outcome. Percent hair reduction from baseline gradually increased with treatment and peaked at 74.6%, 68.4%, and 65.7% for axillary, arm and thigh regions, respectively, 6 months following the last treatment session. Baseline hair growth patterns precluded effective selection of a representative area for hair counting. Patients satisfaction was consistently higher for axillary hair clearance rates, followed by thigh and arm responses. Throughout the follow-up period, the investigator rated 50-67% of the treated axillae as presenting "good" or "very good" hair clearance, and provided similar ratings for 67% of the treated thigh regions at both the 1 and 6 month follow-up sessions. Immediate responses to treatment were mild to moderate and short-lived and no incidents of brosis or scarring were reported. Taken together, the LightSheer In nity 1060 HS Handpiece provided for an ideal ef cacy-safety balance in treating dark-skinned patients, providing for long-term hair clearance with minimal downtime. J Drugs Dermatol. 2016;15(11):1427-1434.

  1. Effect of Pitavastatin Treatment on ApoB-48 and Lp-PLA₂ in Patients with Metabolic Syndrome: Substudy of PROspective Comparative Clinical Study Evaluating the Efficacy and Safety of PITavastatin in Patients with Metabolic Syndrome.

    PubMed

    Lee, Hyo Sun; Jung, Chang Hee; Kim, Sung Rae; Jang, Hak Chul; Park, Cheol Young

    2016-03-01

    Apolipoprotein (Apo) B-48 is an intestinally derived lipoprotein that is expected to be a marker for cardiovascular disease (CVD). Lipoprotein-associated phospholipase A₂ (Lp-PLA₂) is a vascular-specific inflammatory marker and important risk predictor of CVD. The aim of this study was to explore the effect of pitavastatin treatment and life style modification (LSM) on ApoB-48 and Lp-PLA₂ levels in metabolic syndrome (MS) patients at relatively low risk for CVD, as a sub-analysis of a previous multi-center prospective study. We enrolled 75 patients with MS from the PROPIT study and randomized them into two treatment groups: 2 mg pitavastatin daily+intensive LSM or intensive LSM only. We measured the change of lipid profiles, ApoB-48 and Lp-PLA₂ for 48 weeks. Total cholesterol, low density lipoprotein cholesterol, non-high density lipoprotein cholesterol, and ApoB-100/A1 ratio were significantly improved in the pitavastatin+LSM group compared to the LSM only group (P≤0.001). Pitavastatin+LSM did not change the level of ApoB-48 in subjects overall, but the level of ApoB-48 was significantly lower in the higher mean baseline value group of ApoB-48. The change in Lp-PLA₂ was not significant after intervention in either group after treatment with pitavastatin for 1 year. Pitavastatin treatment and LSM significantly improved lipid profiles, ApoB-100/A1 ratio, and reduced ApoB-48 levels in the higher mean baseline value group of ApoB-48, but did not significantly alter the Lp-PLA₂ levels.

  2. Proof Construction and Evaluation Practices of Prospective Mathematics Educators

    ERIC Educational Resources Information Center

    Imamoglu, Yesim; Togrol, Aysenur Yontar

    2015-01-01

    This study was conducted with 93 freshmen and 82 senior prospective mathematicians and mathematics teachers in order to investigate how they construct and evaluate proofs and whether there are any significant differences in their proof construction (with respect to department and grade) and proof evaluation (with respect to department)…

  3. Comparative Evaluation of Anesthetic Efficacy of 2% Lidocaine, 4% Articaine, and 0.5% Bupivacaine on Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial.

    PubMed

    Aggarwal, Vivek; Singla, Mamta; Miglani, Sanjay

    2017-01-01

    To compare the anesthetic efficacy of 1.8 mL of 2% lidocaine with 1:200,000 epinephrine, 4% articaine with 1:100,000 epinephrine, and 0.5% bupivacaine with 1:200,000 epinephrine on producing inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. A total of 91 adult patients who were actively experiencing mandibular molar pain were involved in this study. The patients were randomly divided into three groups on the basis of the anesthetic solution used. The first group received IANB with 1.8 mL of 2% lidocaine with 1:200,000 epinephrine, the second group received IANB with 4% articaine with 1:100,000 epinephrine, and the third group received IANB with 0.5% bupivacaine with 1:200,000 epinephrine. After 15 minutes of IANB, conventional endodontic access preparation was started. The pain during the treatment was noted on a Heft-Parker visual analog scale (HP VAS). The primary outcome measure was anesthetic success, and anesthesia was considered successful if the patient reported no pain or weak/mild pain (HP VAS score < 55 mm) during endodontic treatment (pulp access and canal preparation procedures). The data were analyzed with one-way analysis of variance and chi-square test. The anesthetic success rates of 2% lidocaine, 4% articaine, and 0.5% bupivacaine were 23%, 33%, and 17%, respectively. The differences were statistically insignificant (P > .05). The 2% lidocaine solution used for IANB had similar success rates when compared with 4% articaine and 0.5% bupivacaine.

  4. [A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

    PubMed

    Lu, Quan

    2010-03-01

    To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P < 0.05) and except nasal congestion, the efficacy in all the other symptoms of trial group was better than that in the control group as well on the 7th day (P < 0.01). The improvement rate for combined symptoms of Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

  5. Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks.

    PubMed

    Park, Bernard J; Snider, John M; Bates, Nathan R; Cassivi, Stephen D; Jett, G Kimble; Sonett, Joshua R; Toloza, Eric M

    2016-12-12

    A biodegradable polymeric sealant has been previously shown to reduce postoperative air leaks after open pulmonary resection. The aim of this study was to evaluate safety and efficacy during minimally invasive pulmonary resection. In a multicenter prospective single-arm trial, 112 patients with a median age of 69 years (range 34-87 years) were treated with sealant for at least one intraoperative air leak after standard methods of repair (sutures, staples or cautery) following minimally invasive pulmonary resection (Video-Assisted Thoracic Surgery (VATS) or Robotic-Assisted). Patients were followed in hospital and 1 month after surgery for procedure-related and device-related complications and presence of air leak. Forty patients had VATS and 72 patients had Robotic-Assisted procedures with the majority (80/112, 71%) undergoing anatomic resection (61 lobectomy, 13 segmentectomy, 6 bilobectomy). There were no device-related adverse events. The overall morbidity rate was 41% (46/112), with major complications occurring in 16.1% (18/112). In-hospital mortality and 30-day mortality were 1.9% (2/103). The majority of intraoperative air leaks (107/133, 81%) were sealed after sealant application, and an additional 16% (21/133) were considered reduced. Forty-nine percent of patients (55/112) were free of air leak throughout the entire postoperative study period. Median chest tube duration was 2 days (range 1 - 46 days), and median length of hospitalization was 3 days (range 1 - 20 days). This study demonstrated that use of a biodegradable polymer for closure of intraoperative air leaks as an adjunct to standard methods is safe and effective following minimally invasive pulmonary resection. ClinicalTrials.gov: NCT01867658 . Registered 3 May 2013.

  6. Evaluating Efficacy and Validating Games for Health.

    PubMed

    Kato, Pamela M

    2012-02-01

    The field of games for health is growing rapidly, but many games for health are not validated for their use as a tool to improve outcomes. The few research studies that do exist are often poorly designed, and their conclusions cannot be considered valid evidence to support or refute efficacy. Based on lessons learned from the field of digital game-based learning in education and recent efforts to systematically review games for health in meta-analyses, guidelines are suggested for conducting high-quality efficacy studies on games for health.

  7. Randomized, Double-Blind Phase II Trial With Prospective Classification by ATM Protein Level to Evaluate the Efficacy and Tolerability of Olaparib Plus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer.

    PubMed

    Bang, Yung-Jue; Im, Seock-Ah; Lee, Keun-Wook; Cho, Jae Yong; Song, Eun-Kee; Lee, Kyung Hee; Kim, Yeul Hong; Park, Joon Oh; Chun, Hoo Geun; Zang, Dae Young; Fielding, Anitra; Rowbottom, Jacqui; Hodgson, Darren; O'Connor, Mark J; Yin, Xiaolu; Kim, Woo Ho

    2015-11-20

    Gastric cancer cell lines, particularly those with low levels of ataxia telangiectasia mutated (ATM), a key activator of DNA damage response, are sensitive to the poly (ADP-ribose) polymerase inhibitor olaparib. We compared the efficacy of olaparib plus paclitaxel (olaparib/paclitaxel) with paclitaxel alone in patients with recurrent or metastatic gastric cancer and assessed whether low ATM expression is predictive of improved clinical outcome for olaparib/paclitaxel. In this phase II, double-blind study (Study 39; NCT01063517), patients were randomly assigned to oral olaparib 100 mg twice per day (tablets) plus paclitaxel (80 mg/m(2) per day intravenously on days 1, 8, and 15 of every 28-day cycle) or placebo plus paclitaxel (placebo/paclitaxel), followed by maintenance monotherapy with olaparib (200 mg twice per day) or placebo. The study population was enriched to 50% for patients with low or undetectable ATM levels (ATMlow). Primary end point was progression-free survival (PFS). One hundred twenty-three of 124 randomly assigned patients received treatment (olaparib/paclitaxel, n = 61; placebo/paclitaxel, n = 62). The screening prevalence of ATMlow patients was 14%. Olaparib/paclitaxel did not lead to a significant improvement in PFS versus placebo/paclitaxel (overall population: hazard ratio [HR], 0.80; median PFS, 3.91 v 3.55 months, respectively; ATMlow population: HR, 0.74; median PFS, 5.29 v 3.68 months, respectively). However, olaparib/paclitaxel significantly improved overall survival (OS) versus placebo/paclitaxel in both the overall population (HR, 0.56; 80% CI, 0.41 to 0.75; P = .005; median OS, 13.1 v 8.3 months, respectively) and the ATMlow population (HR, 0.35; 80% CI, 0.22 to 0.56; P = .002; median OS, not reached v 8.2 months, respectively). Olaparib/paclitaxel was generally well tolerated, with no unexpected safety findings. Olaparib/paclitaxel is active in the treatment of patients with metastatic gastric cancer, with a greater OS benefit in

  8. Efficacy and safety of micafungin for febrile neutropenia in pediatric patients with hematological malignancies: a multicenter prospective study.

    PubMed

    Kobayashi, Ryoji; Suzuki, Nobuhiro; Yoshida, Makoto; Iizuka, Susumu; Suzuki, Daisuke; Sano, Hirozumi; Kudoh, Tooru

    2013-10-01

    Invasive fungal infections are a major cause of infectious mortality in neutropenic patients receiving chemotherapy or hematopoietic stem cell transplantation. However, little is known about the efficacy and safety of micafungin (MCFG), an echinocandin antifungal agent, in pediatric patients with febrile neutropenia (FN). This study was conducted as a prospective multicenter trial to evaluate the efficacy and safety of MCFG for FN in pediatric patients with hematological diseases. Efficacy was assessed based on the response to the 5 composite endpoints established by Walsh and colleagues in addition to body temperature and C-reactive protein values. Thirty episodes of FN were enrolled in the study. The median dose and duration of MCFG treatment were 3.0 mg/kg/d and 13.5 days, respectively. Using the criteria of Walsh and colleagues, MCFG was effective in 56.7% of the patients. No breakthrough invasive fungal infection occurred during MCFG treatment. Body temperatures on the last day of neutropenia during administration of MCFG and on the last day of MCFG therapy and C-reactive protein values after administration of MCFG were significantly lower than on the day MCFG therapy was started. Adverse effects in the form of mild liver dysfunction were seen in only 2 patients. MCFG is a very effective and safe antifungal drug for FN in children. Physicians should administer MCFG early in febrile episode in patients in whom first-line antibiotics are not effective in treating FN.

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

    PubMed

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

    2017-03-07

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

  10. Cigarette Smoking and Military Deployment: A Prospective Evaluation

    DTIC Science & Technology

    2007-04-10

    H 3 w a A © ARTICLE IN PRESSResearch Articles igarette Smoking and Military Deployment Prospective Evaluation esa Smith, MPH, PhD, Margaret A.K...2005;73:713–9. 8. Boos CJ, Croft AM. Smoking rates in the staff of a military field hospital before and after wartime deployment. J R Soc Med 2004;97:20...Military Deployment: A Prospective Evaluation 6. AUTHORS Besa Smith, MPH; Margaret A. K. Ryan, MD, MPH; Deborah L. Wingard, PhD; Thomas L. Patterson

  11. Competency Evaluations of Prospective Special Education Teachers.

    ERIC Educational Resources Information Center

    Cellucci, Philomena M. C.; Ragland, G. G.

    A study was undertaken to consider existing, as well as hitherto untried methods, to measure competencies of student teachers in the special education fields and to assess the effectiveness of teacher training programs. The survey, conducted at a university in the Southeast, compared the self-evaluations of 32 undergraduate special education…

  12. MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD.

    PubMed

    Zhang, Jing; Song, Yuan-Lin; Bai, Chun-Xue

    2013-01-01

    Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the 'MIOTIC study' to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management.

  13. MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD

    PubMed Central

    Zhang, Jing; Song, Yuan-lin; Bai, Chun-xue

    2013-01-01

    Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the ‘MIOTIC study’ to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management. PMID:24082784

  14. The effect of multimedia cases on science teaching self-efficacy beliefs of prospective teachers in Kenya

    NASA Astrophysics Data System (ADS)

    Nthiga, Peter Rugano

    This study examined the effects of multimedia cases on science teaching self-efficacy beliefs of prospective teachers in Kenya using mixed methods in data collection and analysis. Collaborating with two teacher educators at Central University, I designed and implemented two multimedia case-based intervention lessons, one with prospective chemistry teachers and the other with prospective physics teachers. I determined the changes in self-efficacy beliefs using a pretest and posttest with the Science Teaching Efficacy Beliefs Instrument (STEBI) for N=41 participants. I also collected data using a worksheet during the intervention lesson. When the prospective teachers went for their field practice, I sampled eight of them for in depth interviews to determine what they drew on from the intervention lesson during their classroom teaching. I used Roth McDuffie's et al. (2014) framing to categorize the comments that the prospective teachers made on the worksheet into the four lenses of teacher, students, task or power and participation. I used paired sample t-test to determine the changes in self-efficacy beliefs and then developed profiles of the prospective teachers from the in depth interviews. The results revealed that prospective teachers paid more attention to the actions of the teacher and paid less attention to students' activities. Their attention to the task was predominantly about the cognitive level of the task and almost always focused on the errors they noted. The prospective teacher noticing using the power and participation lens was not clearly delineable from the teacher lens, because most instructional activities that led to more participation were teacher actions. Science teaching efficacy beliefs has two constructs: personal science teaching efficacy (PSTE) and science teaching outcome expectancy (STOE). The PSTE scores were very high at 4.46 out of five on the pretest, and 4.41 on posttest. There was a decrease in the mean scores, but the change was

  15. Pharmacotherapy for Pediatric Generalized Anxiety Disorder: A Systematic Evaluation of Efficacy, Safety and Tolerability

    PubMed Central

    Dobson, Eric T.; Strawn, Jeffrey R.

    2016-01-01

    Background Randomized controlled trials consistently support the efficacy of antidepressants in treating youth with generalized anxiety disorder (GAD), although integrated examinations of efficacy, safety, and tolerability of psychotropic medications in GAD specifically are rare. With this in mind, we sought to describe the efficacy, safety and tolerability of psychopharmacologic interventions in youth with GAD. Methods Randomized, double-blind, placebo-controlled, prospective trials of psychopharmacologic interventions in youth with GAD were identified through a PubMed/Medline (1966–2015) search. Both authors manually reviewed trials and, to evaluate comparative efficacy and tolerability across medications, numbers needed to treat (NNT) (based on Pediatric Anxiety Rating Scale (PARS) remission criteria (PARS ≤8 [1]), and number needed to harm (NNH) for selected treatment-emergent adverse events (TEAEs) were calculated. Finally, treatment-emergent suicidality and taper-emergent/post-study adverse events are reported descriptively. Results Five trials that involved 1,186 patients and evaluated four medications were reviewed and efficacy data were extracted with regard to dimensional measures of anxiety. SSRI/SNRIs demonstrated efficacy in the reduction of anxiety symptoms with NNTs ranging from 2.8 to 9.3. TEAEs varied considerably between studies but tended to be mild and generally did not lead to discontinuation. Conclusions Data from five trials of SSRI/SNRI in youth with GAD, many of whom had co-occurring separation and social anxiety disorders, suggest superiority to placebo and favorable tolerability profiles. PMID:26660158

  16. Efficacy of Magnesium Trihydrate of Ursodeoxycholic Acid and Chenodeoxycholic Acid for Gallstone Dissolution: A Prospective Multicenter Trial

    PubMed Central

    Hyun, Jong Jin; Lee, Hong Sik; Kim, Chang Duck; Dong, Seok Ho; Lee, Seung-Ok; Ryu, Ji Kon; Lee, Don Haeng; Jeong, Seok; Kim, Tae Nyeun; Lee, Jin; Koh, Dong Hee; Park, Eun Taek; Lee, Inseok; Yoo, Byung Moo; Kim, Jin Hong

    2015-01-01

    Background/Aims Cholecystectomy is necessary for the treatment of symptomatic or complicated gallbladder (GB) stones, but oral litholysis with bile acids is an attractive alternative therapeutic option for asymptomatic or mildly symptomatic patients. This study was conducted to evaluate the efficacy of magnesium trihydrate of ursodeoxycholic acid (UDCA) and chenodeoxycholic acid (CDCA) on gallstone dissolution and to investigate improvements in gallstone-related symptoms. Methods A prospective, multicenter, phase 4 clinical study to determine the efficacy of orally administered magnesium trihydrate of UDCA and CDCA was performed from January 2011 to June 2013. The inclusion criteria were GB stone diameter ≤15 mm, GB ejection fraction ≥50%, radiolucency on plain X-ray, and asymptomatic/mildly symptomatic patients. The patients were prescribed one capsule of magnesium trihydrate of UDCA and CDCA at breakfast and two capsules at bedtime for 6 months. The dissolution rate, response rate, and change in symptom score were evaluated. Results A total of 237 subjects were enrolled, and 195 subjects completed the treatment. The dissolution rate was 45.1% and the response rate was 47.2% (92/195) after 6 months of administration of magnesium trihydrate of UDCA and CDCA. Only the stone diameter was significantly associated with the response rate. Both the symptom score and the number of patients with symptoms significantly decreased regardless of stone dissolution. Adverse events necessitating discontinuation of the drug, surgery, or endoscopic management occurred in 2.5% (6/237) of patients. Conclusions Magnesium trihydrate of UDCA and CDCA is a well-tolerated bile acid that showed similar efficacy for gallstone dissolution and improvement of gallstone-related symptoms as that shown in previous studies. PMID:26087862

  17. A Prospective Cohort Evaluation of a Robotic, Auto-Navigating Operating Microscope.

    PubMed

    Bohl, Michael A; Oppenlander, Mark E; Spetzler, Robert

    2016-06-30

    The unique challenges inherent to microneurosurgery demand that we stay on the forefront of new surgical technologies. Many believe the next major technological advance in neurosurgery will be the widespread application of image-guided robotics in the operating room. We evaluated a novel technology for image-guided robotic auto-navigation of the operating microscope in a prospectively enrolled cohort of patients. Twenty patients were prospectively enrolled for analysis. Data were collected on the extent of resection, operative time, estimated blood loss, time taken to set up the new software, and complications encountered. Software accuracy, reliability, and usefulness in the case were subjectively evaluated. The most commonly  treated pathologies were cavernous malformation (n = 5), arteriovenous malformation (n = 4), and meningioma (n = 4). The time to set up the new software interface before the start of the operation was <60 seconds in all cases. Subjective evaluation in each case revealed the robotic interface to be accurate, reliable, and useful. The new technology was significantly more useful in deeper lesions. The addition of image-guided robotic auto-positioning features to the operating microscope has a great potential to advance the field of neurosurgery. This study is the first prospective evaluation of such a technology in a patient cohort. The results suggest that the newest robotic auto-positioning technology has the potential to improve the neurosurgeon's efficiency and efficacy, thereby positively impacting patient safety and surgical outcomes, especially in cases involving deep-seated lesions.

  18. A Prospective Cohort Evaluation of a Robotic, Auto-Navigating Operating Microscope

    PubMed Central

    Bohl, Michael A; Oppenlander, Mark E

    2016-01-01

    The unique challenges inherent to microneurosurgery demand that we stay on the forefront of new surgical technologies. Many believe the next major technological advance in neurosurgery will be the widespread application of image-guided robotics in the operating room. We evaluated a novel technology for image-guided robotic auto-navigation of the operating microscope in a prospectively enrolled cohort of patients. Twenty patients were prospectively enrolled for analysis. Data were collected on the extent of resection, operative time, estimated blood loss, time taken to set up the new software, and complications encountered. Software accuracy, reliability, and usefulness in the case were subjectively evaluated. The most commonly  treated pathologies were cavernous malformation (n = 5), arteriovenous malformation (n = 4), and meningioma (n = 4). The time to set up the new software interface before the start of the operation was <60 seconds in all cases. Subjective evaluation in each case revealed the robotic interface to be accurate, reliable, and useful. The new technology was significantly more useful in deeper lesions. The addition of image-guided robotic auto-positioning features to the operating microscope has a great potential to advance the field of neurosurgery. This study is the first prospective evaluation of such a technology in a patient cohort. The results suggest that the newest robotic auto-positioning technology has the potential to improve the neurosurgeon's efficiency and efficacy, thereby positively impacting patient safety and surgical outcomes, especially in cases involving deep-seated lesions. PMID:27493844

  19. Efficacy methods to evaluate health communication and marketing campaigns.

    PubMed

    Evans, W Douglas; Uhrig, Jennifer; Davis, Kevin; McCormack, Lauren

    2009-06-01

    Communication and marketing are growing areas of health research, but relatively few rigorous efficacy studies have been conducted in these fields. In this article, we review recent health communication and marketing efficacy research, present two case studies that illustrate some of the considerations in making efficacy design choices, and advocate for greater emphasis on rigorous health communication and marketing efficacy research and the development of a research agenda. Much of the outcomes research in health communication and marketing, especially mass media, utilizes effectiveness designs conducted in real time, in the media markets or communities in which messages are delivered. Such evaluations may be impractical or impossible, however, imiting opportunities to advance the state of health communication and marketing research and the knowledge base on effective campaign strategies, messages, and channels. Efficacy and effectiveness studies use similar measures of behavior change. Efficacy studies, however, offer greater opportunities for experimental control, message exposure, and testing of health communication and marketing theory. By examining the literature and two in-depth case studies, we identify advantages and limitations to efficacy studies. We also identify considerations for when to adopt efficacy and effectiveness methods, alone or in combination. Finally, we outline a research agenda to investigate issues of internal and external validity, mode of message presentation, differences between marketing and message strategies, and behavioral outcomes.

  20. [Results of the multicenter prospective study of cerebrolysin safety and efficacy in acute stroke].

    PubMed

    Skwortsova, V I; Stakhovskaia, L V; Shamalov, N A; Kerbikov, O B

    2006-01-01

    The multicenter prospective study of cerebrolysin safety and efficacy included 277 patients with ischemic stroke aged 55-85 years, who received therapy within 12 h from the disease development. Cerebrolysin was used in dosage 10 ml daily along with concomitant standard basic treatment during 10 days after stroke onset in 138 patients. A control group comprised 139 patients who received basic treatment only. A quantitative analysis of the dynamics of neurological deficit revealed the accelerated improvement by NIHSS score, modified Rankin score and Barthel index in the cerebrolysin group on days 10 and 28 (p<0,05). The significant improvement of NIHSS score was observed on day 28 (p<0,05) in patients treated with cerebrolysin within the first 3h after stroke onset comparing to those treated within 6-12h. The trial demonstrated cerebrolysin safety and good tolerability in treatment of ischemic stroke in the carotid artery territory as well as its favorable clinical effect.

  1. The Efficacy of Stuttering Measurement Training: Evaluating Two Training Programs

    ERIC Educational Resources Information Center

    Bainbridge, Lauren A.; Stavros, Candace; Ebrahimian, Mineh; Wang, Yuedong; Ingham, Roger J.

    2015-01-01

    Purpose: Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Method: Four groups, each with 12 randomly allocated participants, completed a pretest-posttest design training study. They were evaluated by their counts of…

  2. The Efficacy of Stuttering Measurement Training: Evaluating Two Training Programs

    ERIC Educational Resources Information Center

    Bainbridge, Lauren A.; Stavros, Candace; Ebrahimian, Mineh; Wang, Yuedong; Ingham, Roger J.

    2015-01-01

    Purpose: Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Method: Four groups, each with 12 randomly allocated participants, completed a pretest-posttest design training study. They were evaluated by their counts of…

  3. Testing the prospective evaluation of a new healthcare system

    PubMed Central

    Planitz, Birgit; Sanderson, Penelope; Freeman, Clinton; Xiao, Tania; Botea, Adi; Orihuela, Cristina Beltran

    2012-01-01

    Research into health ICT adoption suggests that the failure to understand the clinical workplace has been a major contributing factor to the failure of many computer-based clinical systems. We suggest that clinicians and administrators need methods for envisioning future use when adopting new ICT. This paper presents and evaluates a six-stage “prospective evaluation” model that clinicians can use when assessing the impact of a new electronic patient information system on a Specialist Outpatients Department (SOPD). The prospective evaluation model encompasses normative, descriptive, formative and projective approaches. We show that this combination helped health informaticians to make reasonably accurate predictions for technology adoption at the SOPD. We suggest some refinements, however, to improve the scope and accuracy of predictions. PMID:23304347

  4. Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial

    SciTech Connect

    Ricke, Jens Jürgens, Julian H. W.; Deschamps, Frederic; Tselikas, Lambros; Uhde, Katja; Kosiek, Ortrud; Baere, Thierry De

    2015-04-15

    PurposeTo assess safety and efficacy of irreversible electroporation (IRE) of lung malignancies.Materials and MethodsPatients with primary and secondary lung malignancies and preserved lung function were included in this prospective single arm trial. Primary and secondary endpoints were safety and efficacy. Recruitment goal was 36 subjects in 2 centers. Patients underwent IRE under general anesthesia with probe placement performed in Fluoroscopy-CT. The IRE system employed was NanoKnife{sup ®} (Angiodynamics). System settings for the ablation procedure followed the manufacturer’s recommendations. The Mann–Whitney U test was used to evaluate the correlation of nine technical parameters with local tumor control. Median follow up was 12 months.ResultsThe expected efficacy was not met at interim analysis and the trial was stopped prematurely after inclusion of 23 patients (13/10 between both centers). The dominant tumor entity was colorectal (n = 13). The median tumor diameter was 16 mm (8–27 mm). Pneumothoraces were observed in 11 of 23 patients with chest tubes required in 8 (35 %). Frequently observed alveolar hemorrhage never led to significant hemoptysis. 14/23 showed progressive disease (61 %). Stable disease was found in 1 (4 %), partial remission in 1 (4 %) and complete remission in 7 (30 %) patients. The relative increase of the current during ablation was significantly higher in the group treated successfully as compared to the group presenting local recurrence (p < 0.05). Needle tract seeding was found in three cases (13 %).ConclusionsIRE is not effective for the treatment of lung malignancies. We hypothesize that the energy deposition with current IRE probes is highly sensitive to air exposure.

  5. Efficacy of intravenous dexamethasone to reduce incidence of postoperative sore throat: A prospective randomized controlled trial

    PubMed Central

    Bagchi, Dipanjan; Mandal, Mohan Chandra; Das, Sabyasachi; Sahoo, Tirtha; Basu, Sekhar Ranjan; Sarkar, Sanhita

    2012-01-01

    Background: Sore throat and hoarseness are common complications of endotracheal intubation. It may be very distressing for the patient and may lead to sleep disturbances and unpleasant memories. Materials and Methods: This prospective double-blinded randomized control trial was aimed to determine the efficacy of prophylactic intravenous dexamethasone to reduce the incidence of postoperative sore throat at 1 hour after tracheal extubation. Ninety six patients of either sex aged between 18 to 60 years scheduled for elective surgeries needing general anesthesia with endotracheal intubation, were randomly allocated into two groups A and B. The patients received either intravenous 0.2 mg/kg dexamethasone (group A, n = 48) or normal saline (group B, n = 47) just before induction. Trachea was intubated with appropriate size disposable endotracheal tubes for securing the airway. Follow up for the incidence of sore throat, cough and hoarseness was done at 1, 6 and 24 hours post-extubation. Results: At 1 hour post-extubation, the incidence of sore throat in the control group was 48.9% compared with 18.8% in the dexamethasone group (P<0.002). Conclusions: Prophylactic intravenous dexamethasone in a dose of 0.2 mg/kg can reduce the incidence of postoperative sore throat at 1 hour post-extubation by around 30%, with the efficacy being around 60%. PMID:23225928

  6. Safety and efficacy of daptomycin in outpatient parenteral antimicrobial therapy: a prospective and multicenter cohort study (DAPTODOM trial).

    PubMed

    Cervera, Carlos; Sanroma, Pedro; González-Ramallo, Víctor; García de la María, Cristina; Sanclemente, Gemma; Sopena, Nieves; Pajarón, Marcos; Segado, Antonio; Mirón, Manuel; Antón, Francisco; Basterretxea, Andima; Cuende, Ana; Miró, José M

    2017-03-01

    Daptomycin is an optimal choice for outpatient parenteral antibiotic therapy (OPAT) because of its safety, once-daily administration and its activity against Gram-positive bacteria. Although daptomycin is increasingly being used in OPAT, limited information about its safety in this scenario is available. We performed a prospective multicentre pilot study to evaluate the safety of daptomycin in outpatients with proved or suspected Gram-positive infections (DAPTODOM). The primary objective was to evaluate the safety and the secondary objective to evaluate the efficacy in OPAT. We also looked at the development of daptomycin resistance in those cases with microbiological failure. We included 54 patients from 12 Spanish hospitals, 67% male with a mean age of 67.1 years. Most patients (87%) had chronic underlying diseases. The main reason for inclusion was skin and soft-tissue infections in 52%, followed by bacteremia or endocarditis in 34%. Staphylococcus aureus accounted for 44% of the isolates (24% were methicillin-resistant), coagulase-negative staphylococci 15% and enterococci 7%. Two patients (4%) had to be readmitted because of complications; only one patient had an adverse effect related to daptomycin (increase in serum creatine kinase levels), which disappeared after discontinuation (2%). At the end of follow-up, 96% of patients had good outcome and only 4% of patients did not have a clinical or microbiological cure. The use of a 2-minute bolus in 18 cases was not associated with adverse effects. Daptomycin was safe and efficacious in outpatients with Gram-positive bacterial infections and can be administered in 2-minute bolus infusion.

  7. A Review of Relationship between Prospective Science Teachers' Attitudes towards Science Education and Their Self-Efficacy

    ERIC Educational Resources Information Center

    Türer, Betül; Kunt, Halil

    2015-01-01

    In this research, we aim to review relationship between prospective science teachers' attitudes against science education (physics, chemistry, biology, laboratory) and their self-efficacy. Population of the research constitutes 497 students studying Science Education in Department of Elementary Education in Celal Bayar University Faculty of…

  8. Burnout, Self-Efficacy, and Successful Intelligence among Chinese Prospective and In-Service School Teachers in Hong Kong

    ERIC Educational Resources Information Center

    Chan, David W.

    2007-01-01

    This study assessed the three components of burnout (emotional exhaustion, depersonalisation, and reduced personal accomplishment), perceived self-efficacy, and the three triarchic abilities (analytical, synthetic, and practical) of successful intelligence in a sample of 267 Chinese prospective and in-service teachers in Hong Kong. The aim was to…

  9. Prospective Early Childhood Educators' Meta-Cognitive Knowledge and Teacher Self-Efficacy: Exploring Domain-Specific Associations

    ERIC Educational Resources Information Center

    Kim, Yeon Ha

    2011-01-01

    The present study explored South Korean prospective early childhood educators' situation-specific meta-cognitive knowledge about five problem-solving strategies, investigating whether situated strategic knowledge contributed to teacher self-efficacy domains. Overall, pre-service teachers with higher meta-cognitive knowledge were found to have…

  10. Burnout, Self-Efficacy, and Successful Intelligence among Chinese Prospective and In-Service School Teachers in Hong Kong

    ERIC Educational Resources Information Center

    Chan, David W.

    2007-01-01

    This study assessed the three components of burnout (emotional exhaustion, depersonalisation, and reduced personal accomplishment), perceived self-efficacy, and the three triarchic abilities (analytical, synthetic, and practical) of successful intelligence in a sample of 267 Chinese prospective and in-service teachers in Hong Kong. The aim was to…

  11. Emotional Intelligence, Self-Efficacy, and Coping among Chinese Prospective and In-Service Teachers in Hong Kong

    ERIC Educational Resources Information Center

    Chan, David W.

    2008-01-01

    Emotional intelligence (intrapersonal and interpersonal) and general teacher self-efficacy were assessed to represent personal resources facilitating active and passive coping in a sample of 273 Chinese prospective and in-service teachers in Hong Kong. Intrapersonal emotional intelligence and interpersonal emotional intelligence were found to…

  12. Are Prospective Elementary School Teachers' Social Studies Teaching Efficacy Beliefs Related to Their Learning Approaches in a Social Studies Teaching Methods Course?

    ERIC Educational Resources Information Center

    Dündar, Sahin

    2015-01-01

    This study aimed to contribute to the growing literature on learning approaches and teacher self-efficacy beliefs by examining associations between prospective elementary school teachers' learning approaches in a social studies teaching methods course and their social studies teaching efficacy beliefs. One hundred ninety-two prospective elementary…

  13. Reinforcement magnitude: an evaluation of preference and reinforcer efficacy.

    PubMed

    Trosclair-Lasserre, Nicole M; Lerman, Dorothea C; Call, Nathan A; Addison, Laura R; Kodak, Tiffany

    2008-01-01

    Consideration of reinforcer magnitude may be important for maximizing the efficacy of treatment for problem behavior. Nonetheless, relatively little is known about children's preferences for different magnitudes of social reinforcement or the extent to which preference is related to differences in reinforcer efficacy. The purpose of the current study was to evaluate the relations among reinforcer magnitude, preference, and efficacy by drawing on the procedures and results of basic experimentation in this area. Three children who engaged in problem behavior that was maintained by social positive reinforcement (attention, access to tangible items) participated. Results indicated that preference for different magnitudes of social reinforcement may predict reinforcer efficacy and that magnitude effects may be mediated by the schedule requirement.

  14. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

    PubMed

    Pierot, Laurent; Moret, Jacques; Barreau, Xavier; Szikora, Istvan; Herbreteau, Denis; Turjman, Francis; Holtmannspötter, Markus; Januel, Anne-Christine; Costalat, Vincent; Fiehler, Jens; Klisch, Joachim; Gauvrit, Jean-Yves; Weber, Werner; Desal, Hubert; Velasco, Stéphane; Liebig, Thomas; Stockx, Luc; Berkefeld, Joachim; Molyneux, Andrew; Byrne, James; Spelle, Laurent

    2017-09-30

    Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy. To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2. WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%. This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment. French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. A prospective study on the efficacy of octreotide in the management of malignant bowel obstruction in gynecologic cancer.

    PubMed

    Watari, Hidemichi; Hosaka, Masayoshi; Wakui, Yukio; Nomura, Eiji; Hareyama, Hitoshi; Tanuma, Fumie; Hattori, Rifumi; Azuma, Masaki; Kato, Hidenori; Takeda, Naoki; Ariga, Satoshi; Sakuragi, Noriaki

    2012-05-01

    Malignant bowel obstruction (MBO), of which symptoms lead to a poor quality of life, is a common and distressing clinical complication in advanced gynecologic cancer. The aim of this study was to prospectively assess the clinical efficacy of octreotide to control vomiting in patients with advanced gynecologic cancer with inoperable gastrointestinal obstruction. Patients with advanced gynecologic cancer, who presented at least one episode of vomiting per day due to MBO, were enrolled in this prospective study from 2006 to 2009. Octreotide was administered when necessary at doses starting with 300 μg up to 600 μg a day by continuous infusion for 2 weeks. Primary end point was vomiting control, which was evaluated by common terminology criteria for adverse events version 3 (CTCAE v3.0). Adverse events were also evaluated by CTCAE v3.0. Twenty-two cases were enrolled in this study. Octreotide controlled vomiting in 15 cases (68.2%) to grade 0 and 3 cases (13.6%) to grade 1 on CTCAE v3.0. Overall response rate to octreotide treatment was 81.8% in our patients' cohort. Among 14 cases without nasogastric tube, the overall response rate was 93.1% (13/14). Among 8 cases with nasogastric tube, 4 cases were free of tube with decrease of drainage, and overall response rate was 62.5% (5/8). No major adverse events related to octreotide were reported. We conclude that 300-μg/d dose of octreotide was effective and safe for Japanese patients with MBO by advanced gynecologic cancer. Octreotide could contribute to better quality of life by avoiding placement of nasogastric tube.

  16. Development of an Instrument to Assess Prospective Elementary Teacher Self-Efficacy Beliefs about Equitable Science Teaching and Learning (SEBEST)

    NASA Astrophysics Data System (ADS)

    Ritter, Jennifer M.; Boone, William J.; Rubba, Peter A.

    2001-06-01

    This paper presents an overview of the procedures used to develop and validate an instrument to measure the self-efficacy beliefs of prospective elementary teachers about equitable science teaching and learning. The instrument, titled the SEBEST, was based on the work of Ashton and Webb (1986a, 1986b) and Bandura (1977, 1986). It was modeled after the Science Teaching Efficacy Belief Instrument (STEBI) (Riggs, 1988) and the Science Teaching Efficacy Belief Instrument for Prospective Teachers (STEBI-B) (Enochs & Riggs, 1990). Based on the standardized development procedures used and associated evidence, the SEBEST appears to be a content and construct valid instrument, with high internal reliability qualities. "Most probable response" plots are introduced and used to bring meaning to SEBEST raw scores.

  17. Prospect evaluation as a function of numeracy and probability denominator.

    PubMed

    Millroth, Philip; Juslin, Peter

    2015-05-01

    This study examines how numeracy and probability denominator (a direct-ratio probability, a relative frequency with denominator 100, a relative frequency with denominator 10,000) affect the evaluation of prospects in an expected-value based pricing task. We expected that numeracy would affect the results due to differences in the linearity of number perception and the susceptibility to denominator neglect with different probability formats. An analysis with functional measurement verified that participants integrated value and probability into an expected value. However, a significant interaction between numeracy and probability format and subsequent analyses of the parameters of cumulative prospect theory showed that the manipulation of probability denominator changed participants' psychophysical response to probability and value. Standard methods in decision research may thus confound people's genuine risk attitude with their numerical capacities and the probability format used.

  18. Efficacy of a comprehensive program for reducing stress in women: a prospective, randomized trial.

    PubMed

    Wiegand, Benjamin; Luedtke, Kathryn; Friscia, Diana; Nair, Mona; Aleles, Margaret; McCloskey, Richard

    2010-04-01

    This study evaluated the efficacy of a comprehensive stress management program in reducing perceived stress among women who reported moderate-to-high stress levels. A total of 562 highly motivated females, aged 25-45, with moderate to high stress levels, were enrolled in a 14-week study. Participants were randomized into one of three groups: Group 1 included Internet-based coaching focusing on behavior modification, daily use of proprietary olfactive-based personal care products, and periodic feedback reports; Group 2 consisted of only online coaching; and Group 3 had no active stress management program. Participants in the three groups filled out validated psychometric assessments at baseline and throughout the study period. Several outcomes including Perceived Stress Scale (PSS), Profile of Mood States (POMS), St Mary's Hospital Sleep Questionnaire (SMS), the Trier Inventory of Chronic Stress (TICS), Spielberger State-Trait Anxiety Inventory (STAI), Short-Form-36 (SF-36) and the Work Productivity and Activity Impairment (WPAI), were measured periodically to assess changes in subject-perceived stress, stress-related comorbidities, and sleep quality and to evaluate overall program efficacy. Ethical approval of protocols was conducted by the Allendale Investigational Review Board (AIRB). Voluntary informed consent was obtained from each subject. At the end of the 14-week study period, subjects in Group 1 had statistically significant improvement in the PSS score vs. Group 3 (p < 0.01). There were statistically significant improvements in other efficacy outcomes such as POMS total mood disturbance, TICS work overload and social responsibility subscales, STAI and in the number of night awakenings, assessed by the SMS questionnaire (p < 0.05). Self-reported program efficacy was also significantly higher for Group 1 (p < 0.001). Despite study limitations, including reduction of stress in Group 3, this study demonstrates that this comprehensive stress management program

  19. A Psychometric Evaluation of the Self-Presentational Efficacy Scale

    ERIC Educational Resources Information Center

    Lamarche, Larkin; Gammage, Kimberley L.; Sullivan, Philip J.; Gabriel, David A.

    2013-01-01

    This study examined the psychometric properties of the Self-Presentational Efficacy Scale (SPES) developed by Gammage, Hall, and Martin Ginis (2004). University students (196 men and 269 women) completed the SPES and measures of social physique anxiety, fear of negative evaluation, and physical activity. Participants also completed the SPES a…

  20. A Psychometric Evaluation of the Self-Presentational Efficacy Scale

    ERIC Educational Resources Information Center

    Lamarche, Larkin; Gammage, Kimberley L.; Sullivan, Philip J.; Gabriel, David A.

    2013-01-01

    This study examined the psychometric properties of the Self-Presentational Efficacy Scale (SPES) developed by Gammage, Hall, and Martin Ginis (2004). University students (196 men and 269 women) completed the SPES and measures of social physique anxiety, fear of negative evaluation, and physical activity. Participants also completed the SPES a…

  1. The Efficacy of Math Coaching: An Evaluative Case Study

    ERIC Educational Resources Information Center

    Dobbins, C. Neelie

    2010-01-01

    There is a lack of implementation of instructional strategies to assist middle school teachers in improving mathematics education for their students. Coaching is one solution to this problem, but its impact on student achievement is unclear. This case study evaluated the relationship between coaching and teacher efficacy and the impact of these…

  2. A prospective open-label study to assess the efficacy and safety of a herbal medicinal product (Sinupret) in patients with acute rhinosinusitis.

    PubMed

    Passali, Desiderio; Loglisci, Michele; Passali, Giulio Cesare; Cassano, Pasquale; Rodriguez, Hugo Anibal; Bellussi, Luisa Maria

    2015-01-01

    We present a multicenter, prospective, open-label study to assess the efficacy and safety of a phytomedicine. The aim of the research was to evaluate the efficacy and safety of 14 days of treatment with Sinupret for acute rhinosinusitis. Sinupret is a herbal preparation used to restore and maintain the physiological function of the membranes in the sinus cavity. Sixty patients with acute rhinosinusitis based on the EPOS guidelines were enrolled in the study. Thirty patients were treated with Sinupret Forte, while 30 patients were treated with intranasal fluticasone furoate. The criteria for the evaluation of efficacy were the major symptom scores according to the investigator and the Health-Related Quality of Life score. The criteria used to evaluate safety were the number of patients with adverse events, the patients' vital signs, and laboratory safety. All patients considered showed significant improvements in symptoms. Among the patients treated with Sinupret, none had an adverse event, while 3 patients treated with fluticasone furoate had minor adverse events. The patients' vital signs and laboratory values were normal. The results of this study suggest that this phytomedicinal preparation has a significant level of efficacy in acute rhinosinusitis and that treatment is safe. © 2015 S. Karger AG, Basel.

  3. Cardiac catheterization laboratory inpatient forecast tool: a prospective evaluation.

    PubMed

    Toerper, Matthew F; Flanagan, Eleni; Siddiqui, Sauleh; Appelbaum, Jeff; Kasper, Edward K; Levin, Scott

    2016-04-01

    To develop and prospectively evaluate a web-based tool that forecasts the daily bed need for admissions from the cardiac catheterization laboratory using routinely available clinical data within electronic medical records (EMRs). The forecast model was derived using a 13-month retrospective cohort of 6384 catheterization patients. Predictor variables such as demographics, scheduled procedures, and clinical indicators mined from free-text notes were input to a multivariable logistic regression model that predicted the probability of inpatient admission. The model was embedded into a web-based application connected to the local EMR system and used to support bed management decisions. After implementation, the tool was prospectively evaluated for accuracy on a 13-month test cohort of 7029 catheterization patients. The forecast model predicted admission with an area under the receiver operating characteristic curve of 0.722. Daily aggregate forecasts were accurate to within one bed for 70.3% of days and within three beds for 97.5% of days during the prospective evaluation period. The web-based application housing the forecast model was used by cardiology providers in practice to estimate daily admissions from the catheterization laboratory. The forecast model identified older age, male gender, invasive procedures, coronary artery bypass grafts, and a history of congestive heart failure as qualities indicating a patient was at increased risk for admission. Diagnostic procedures and less acute clinical indicators decreased patients' risk of admission. Despite the site-specific limitations of the model, these findings were supported by the literature. Data-driven predictive analytics may be used to accurately forecast daily demand for inpatient beds for cardiac catheterization patients. Connecting these analytics to EMR data sources has the potential to provide advanced operational decision support. © The Author 2015. Published by Oxford University Press on behalf of the

  4. Prospective evaluation of a pediatric inpatient early warning scoring system.

    PubMed

    Tucker, Karen M; Brewer, Tracy L; Baker, Rachel B; Demeritt, Brenda; Vossmeyer, Michael T

    2009-04-01

    The present study evaluated the use of the Pediatric Early Warning Score (PEWS) for detecting clinical deterioration among hospitalized children. A prospective, descriptive study design was used. The tool was used to score 2,979 patients admitted to a single medical unit of a pediatric hospital over a 12-month period. PEWS discriminated between children who required transfer to the pediatric intensive care unit and those who did not require transfer (area under the curve = 0.89, 95% CI = 0.84-0.94, p < .001). The PEWS tool was found to be a reliable and valid scoring system to identify children at risk for clinical deterioration.

  5. Diagnostic efficacy of color Doppler ultrasound in evaluation of cervical lymphadenopathy.

    PubMed

    Misra, Deepankar; Panjwani, Sapna; Rai, Shalu; Misra, Akansha; Prabhat, Mukul; Gupta, Prashant; Talukder, Subrata K

    2016-01-01

    To evaluate the efficacy of color Doppler ultrasound (CDUS) in differentiating benign and malignant cervical lymph nodes by detecting differences in blood flow patterns. In this cross-sectional prospective study, 25 untreated patients with clinical evidence of cervical lymphadenopathy were evaluated. CDUS was performed for 80 cervical lymph nodes. The gray scale parameters of the lymph node and intranodal perfusion sites were the key CDUS features used to differentiate between reactive and metastatic lymph nodes. Histopathological confirmations were obtained and compared with the results of CDUS. Initially, 53 cervical lymph nodes were evaluated by clinical examination. Twenty-seven additional lymph nodes (53 + 27 = 80) were discovered by CDUS evaluation. Gray scale parameters for lymph nodes such as size of lymph node, shape of lymph node, and presence or absence of hilum revealed highly significant results (P < 0.0001). Color Doppler flow signals revealed that central/hilar flow was characteristic for benign nodes whereas peripheral/mixed flow was characteristic for malignant nodes, the findings were highly significant (P < 0.0001). Gray scale and color Doppler features are used to differentiate benign and malignant nodes. Within the limitations of this study, CDUS evaluation was found to be highly significant with a high sensitivity and specificity over clinical evaluation CDUS examination provides a prospect to reduce the need for biopsy/fine needle aspiration cytology in reactive nodes.

  6. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI)

    PubMed Central

    2014-01-01

    Background Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide. Management of CAP for many patients requires rapid initiation of empirical antibiotic treatment, based on the spectrum of activity of available antimicrobial agents and evidence on local antibiotic resistance. Few data exist on the severity profile and treatment of hospitalized CAP patients in Eastern and Central Europe and the Middle East, in particular on use of moxifloxacin (Avelox®), which is approved in these regions. Methods CAPRIVI (Community Acquired Pneumonia: tReatment wIth AVelox® in hospItalized patients) was a prospective observational study in 12 countries: Croatia, France, Hungary, Kazakhstan, Jordan, Kyrgyzstan, Lebanon, Republic of Moldova, Romania, Russia, Ukraine, and Macedonia. Patients aged >18 years were treated with moxifloxacin 400 mg daily following hospitalization with a CAP diagnosis. In addition to efficacy and safety outcomes, data were collected on patient history and disease severity measured by CRB-65 score. Results 2733 patients were enrolled. A low severity index (i.e., CRB-65 score <2) was reported in 87.5% of CAP patients assessed (n = 1847), an unexpectedly high proportion for hospitalized patients. Moxifloxacin administered for a mean of 10.0 days (range: 2.0 to 39.0 days) was highly effective: 96.7% of patients in the efficacy population (n = 2152) improved and 93.2% were cured of infection during the study. Severity of infection changed from “moderate” or “severe” in 91.8% of patients at baseline to “no infection” or “mild” in 95.5% at last visit. In the safety population (n = 2595), 127 (4.9%) patients had treatment-emergent adverse events (TEAEs) and 40 (1.54%) patients had serious TEAEs; none of these 40 patients died. The safety results were consistent with the known profile of moxifloxacin. Conclusions The efficacy and safety profiles of moxifloxacin at the recommended

  7. Pethidine efficacy in achieving the ultrasound-guided oblique subcostal transversus abdominis plane block in laparoscopic cholecystectomy: A prospective study

    PubMed Central

    Breazu, Caius Mihai; Ciobanu, Lidia; Bartos, Adrian; Bodea, Raluca; Mircea, Petru Adrian; Ionescu, Daniela

    2017-01-01

    Pethidine is a synthetic opioid with local anesthetic properties. Our goal was to evaluate the analgesic efficacy of pethidine for achieving the ultrasound-guided oblique subcostal transversus abdominis plane (OSTAP) block in laparoscopic cholecystectomy. This prospective, double-blind study included 79 patients of physical status I and II according to American Society of Anesthesiologists, scheduled for elective laparoscopic cholecystectomy. The patients were randomly allocated into three groups, depending on the drug used to achieve preoperative bilateral OSTAP block: 1) OSTAP-Placebo (treated with normal saline); 2) OSTAP-Bupivacaine (treated with 0.25% bupivacaine); and 3) OSTAP-Pethidine (treated with 1% pethidine). The efficacy of pethidine in achieving the OSTAP block was analyzed using visual analog scale (VAS), intraoperative opioid dose, opioid consumption in post anesthesia care unit, and opioid consumption in the first 24 postoperative hours. The pain scores assessed by VAS at 0, 2, 4, 6, 12, and 24 hours were significantly lower in OSTAP-Pethidine than in OSTAP-Placebo group (p < 0.001). The mean intraoperative opioid consumption was significantly lower in OSTAP-Pethidine compared to OSTAP-Placebo group (150 versus 400 mg, p < 0.001), as well as the mean opioid consumption in the first 24 hours (20.4 versus 78 mg, p < 0.001). Comparing VAS assessment between OSTAP-Bupivacaine and OSTAP-Pethidine groups, statistically significant differences were observed only for the immediate postoperative pain assessment (0 hours), where lower values were observed in OSTAP-Pethidine group (p = 0.004). There were no statistically significant differences in the incidence of postoperative nausea and vomiting (p = 0.131) between the groups. The use of 1% pethidine can be an alternative to 0.25% bupivacaine in achieving OSTAP block for laparoscopic cholecystectomy. PMID:28027453

  8. A prospective randomized controlled trial assessing the efficacy of adjunctive hyperbaric oxygen therapy in the treatment of hidradenitis suppurativa.

    PubMed

    Yildiz, Hamza; Senol, Levent; Ercan, Erdinc; Bilgili, Memet Ersan; Karabudak Abuaf, Ozlem

    2016-02-01

    Hyperbaric oxygen therapy (HBOT) appears to enhance wound healing, increase bactericidal activity, and act synergistically with a number of antibiotics. The aim of this study was to evaluate the efficacy of HBOT as an adjunctive therapy in patients with hidradenitis suppurativa (HS) treated with a combination of systemic rifampicin and clindamycin. The study was a prospective, single-center, single-dose, open-label, randomized controlled clinical study of HBOT in patients with moderate to severe HS. Efficacy was measured by modified Sartorius score (SS), HS Severity Index (HSSI), Dermatology Life Quality Index (DLQI), and a visual analog scale (VAS) before treatment and after the completion of 4 and 10 weeks of treatment. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were also measured. Forty-three patients were enrolled in the study. More patients in the HBOT than in the control group showed a decrease of ≥50% from baseline parameters at week 10 for SS (100%), HSSI (100%), DLQI (95.5%), VAS (100%), ESR (100%), and CRP (72.7%). Clinically and statistically significant improvements from baseline were observed at 4 and 10 weeks in HSSI (P = 0.009 at both), SS (P = 0.021 at both), and DLQI (P = 0.044 at week 4, P = 0.009 at week 10). Adjunctive HBOT was considered to be effective in significantly improving antibiotic treatment of HS. The treatment was well tolerated, and no unexpected safety issues were identified.

  9. Comparative efficacy of tadalafil versus tamsulosin as the medical expulsive therapy in lower ureteric stone: a prospective randomized trial

    PubMed Central

    Mylarappa, Prasad; Aggarwal, Kuldeep; Patil, Avinash; Joshi, Prarthan; Desigowda, Ramesh

    2016-01-01

    Introduction In recent years, medical expulsive therapy has been used in the management of distal ureteric stones as a supplement to conservative treatment. Therefore, we conducted a prospective randomized study to evaluate the possible role of tadalafil individually in comparison with proven tamsulosin therapy in ureteric stone expulsion. The aim of this study is to compare the safety and efficacy of a phosphodiesterase-5 inhibitor (tadalafil) and an α-1 blocker (tamsulosin) as medical expulsive therapy for distal ureteric calculi. Material and methods Between August 2014 and October 2015, 207 patients who presented with distal ureteric stones of size 5–10 mm were randomly divided into two groups: tadalafil (Group A) and tamsulosin (Group B). Therapy was given for a maximum of 4 weeks. Stone expulsion rate, time to stone expulsion, analgesic use, number of hospital visits for pain, follow-up, endoscopic treatment and adverse effects of drugs were noted. Both groups were compared for normally distributed data by percentage, analysis of variance, and T-test. All the classified and categorical data were analyzed for both groups using the chi-square test. Results A statistically significant expulsion rate of 84.0% in Group A compared with 68.0% in Group B (P value = 0.0130), and shorter stone expulsion time in Group A (14.7±3.8) in comparison to Group B (16.8 ±4.5) was observed. Statistically significant differences were noted in renal colic episodes and analgesic requirement in Group A than Group B. No serious adverse effects were noted. Conclusions Tadalafil is safe, efficacious, and well tolerated as medical expulsive therapy for distal ureteric stones. This study showed that tadalafil increases ureteric stone expulsion quite significantly along with better control of pain and significantly lower analgesic requirement. PMID:27551555

  10. Treating Small Bowel Obstruction with a Manual Physical Therapy: A Prospective Efficacy Study.

    PubMed

    Rice, Amanda D; Patterson, Kimberley; Reed, Evette D; Wurn, Belinda F; Klingenberg, Bernhard; King, C Richard; Wurn, Lawrence J

    2016-01-01

    Small bowel obstructions (SBOs) caused by adhesions are a common, often life-threatening postsurgical complication with few treatment options available for patients. This study examines the efficacy of a manual physical therapy treatment regimen on the pain and quality of life of subjects with a history of bowel obstructions due to adhesions in a prospective, controlled survey based study. Changes in six domains of quality of life were measured via ratings reported before and after treatment using the validated Small Bowel Obstruction Questionnaire (SBO-Q). Improvements in the domains for pain (p = 0.0087), overall quality of life (p = 0.0016), and pain severity (p = 0.0006) were significant when average scores before treatment were compared with scores after treatment. The gastrointestinal symptoms (p = 0.0258) domain was marginally significant. There was no statistically significant improvement identified in the diet or medication domains in the SBO-Q for this population. Significant improvements in range of motion in the trunk (p ≤ 0.001), often limited by adhesions, were also observed for all measures. This study demonstrates in a small number of subjects that this manual physical therapy protocol is an effective treatment option for patients with adhesive small bowel obstructions as measured by subject reported symptoms and quality of life.

  11. Prospective Randomized Trial Comparing the Efficacy of Surgical Preparation Solutions in Hand Surgery.

    PubMed

    Xu, Peter Z; Fowler, John R; Goitz, Robert J

    2017-05-01

    Decontamination of the skin prior to incision is part of the standard of care for any surgical procedure. Previous studies have demonstrated variable efficacy of different surgical preparation solutions based on anatomic location. The purpose of this study is to determine the effectiveness of 3 commonly used surgical preparation solutions in eliminating bacteria from the skin prior to incision for common elective soft tissue hand procedures. A total of 240 patients undergoing clean, elective, soft tissue hand surgery were prospectively randomized to 1 of 3 groups (ChloraPrep, DuraPrep, or Betadine). Prepreparation and postpreparation cultures were obtained adjacent to the surgical incision and neutralization was performed on the obtained specimen. Cultures were held for 14 days and patients followed for 6 weeks postoperatively. Postpreparation cultures were positive in 21 of 80 (26.3%) ChloraPrep patients, 3 of 79 (3.8%) DuraPrep patients, and 1 of 81 (1.2%) Betadine patients ( P < .001). There was no difference in the postpreparation culture rate between DuraPrep and Betadine ( P = 1.000). Duraprep and Betadine were found to be superior to Chloraprep for skin decontamination prior to clean elective soft tissue hand surgery. The bacterial flora of the hand was found to be different from those of the shoulder and spine. The clinical significance of this finding requires clinical consideration because the majority of prepreparation and postpreparation positive cultures were of Bacillus species, which are rarely a cause of postoperative infections.

  12. Efficacy of low dose gabapentin in acute herpes zoster for preventing postherpetic neuralgia: a prospective controlled study.

    PubMed

    Lee, Eo G; Lee, Hee J; Hyun, Dong J; Min, Kyunghoon; Kim, Dong H; Yoon, Moon S

    2016-05-01

    Postherpetic neuralgia (PHN) is a sequela of herpes zoster that adversely affects quality of life seriously. The risk factors for PHN are well known but the effective interventions that reduce the incidence of PHN are less studied. The objective of this study is to evaluate the efficacy of treatment with gabapentin in patients with acute herpes zoster for preventing PHN. We performed a prospective randomized controlled study of 120 participants diagnosed with acute herpes zoster, aged 50 and over and complaining moderate to severe pain. All patients were treated with valacyclovir and acetaminophen. Half of the participants were assigned to the gabapentin group and received gabapentin 300 mg three times a day additionally. The intensity of pain at every visit and the incidence of PHN in both groups were measured. Total 52 and 49 patients in the gabapentin group and the control group, respectively, had completed 12 weeks of follow-up period. Although the incidence of PHN was higher in the control group, the difference was not statistically significant (6.1% vs. 3.8%, p = 0.67). Our results indicate that the use of low-dose gabapentin in acute herpes zoster seems not effective in the prevention of PHN. © 2016 Wiley Periodicals, Inc.

  13. Evaluating efficacy of an environmental policy to prevent biological invasions.

    PubMed

    Bailey, Sarah A; Deneau, Matthew G; Jean, Laurent; Wiley, Chris J; Leung, Brian; MacIsaac, Hugh J

    2011-04-01

    Enactment of any environmental policy should be followed by an evaluation of its efficacy to ensure optimal utilization of limited resources, yet measuring the success of these policies can be a challenging task owing to a dearth of data and confounding factors. We examine the efficacy of ballast water policies enacted to prevent biological invasions in the Laurentian Great Lakes. We utilize four criteria to assess the efficacy of this environmental regulation: (1) Is the prescribed management action demonstrably effective? (2) Is the management action effective under operational conditions? (3) Can compliance be achieved on a broad scale? (4) Are desired changes observed in the environment? The four lines of evidence resulting from this analysis indicate that the Great Lakes ballast water management program provides robust, but not complete, protection against ship-mediated biological invasions. Our analysis also indicates that corresponding inspection and enforcement efforts should be undertaken to ensure that environmental policies translate into increased environmental protection. Similar programs could be implemented immediately around the world to protect the biodiversity of the many freshwater ecosystems which receive ballast water discharges by international vessels. This general framework can be extended to evaluate efficacy of other environmental policies.

  14. The Prospective Associations between Self-Efficacy and Depressive Symptoms from Early to Middle Adolescence: A Cross-Lagged Model.

    PubMed

    Tak, Yuli R; Brunwasser, Steven M; Lichtwarck-Aschoff, Anna; Engels, Rutger C M E

    2017-04-01

    Over the course of adolescence, an increasing number of adolescents experience depression. In order to effectively target depression, identifying risk factors for depressive symptoms is pivotal. Since low levels of self-efficacy were associated with higher levels of depressive symptoms in previous studies, the current study investigated the bidirectional and prospective associations between depressive symptoms and academic, social and emotional self-efficacy from early to mid adolescence in a cross-lagged path model. The sample consisted of 1,341 adolescents (47 % girls) with a mean age of 14 years, SD = 0.56. Depressive symptoms and self-efficacy levels were assessed every 6 months over a period of 2.5 years. Depressive symptoms predicted subsequent levels of academic and emotional self-efficacy on all time points, and social self-efficacy on one time point. Self-efficacy did not predict subsequent levels of depressive symptoms. There was no evidence of sex differences in the cross-lagged associations between depressive symptoms and self-efficacy levels. Implications of the findings are discussed.

  15. Fasting versus gradual initiation of the ketogenic diet: a prospective, randomized clinical trial of efficacy.

    PubMed

    Bergqvist, A G Christina; Schall, Joan I; Gallagher, Paul R; Cnaan, Avital; Stallings, Virginia A

    2005-11-01

    The ketogenic diet (KD) is a 90% fat diet that is an effective treatment for intractable epilepsy. Rapid initiation of the KD requires hospital admission because of the complexity of the protocol and frequent mild and moderate adverse events. The purpose of the study was to compare the efficacy of a gradual KD initiation with the standard KD initiation preceded by a 24- to 48-h fast. Children ages 1 to 14 years with intractable epilepsy were randomized to a fasting initiation (FAST-KD) or gradual initiation (GRAD-KD). Baseline seizure activity was recorded daily for 28 days before admission and continued for the 3-month duration of the study. Effectiveness was measured in two ways: (a) the proportion of subjects with >50% reduction in target seizure type from baseline to 3-month evaluation, and (b) percentage reduction in the frequency of the target seizure type from baseline to 3-month evaluation. Blood glucose was assessed q4 to 6h, and weights, electrolytes, hydration status, vomiting, acid balance, need for interventions (citric acid and sodium citrates (Bicitra) and IV fluids) were assessed daily. Fisher's exact tests were used to examine the association between protocol and occurrence of adverse events, and longitudinal mixed-effects models were used to look for trends in tolerability data over time. Forty-eight subjects, 24 in each arm, were randomized. In the FAST-KD protocol, 58% of the children had >50% reduction in the target seizure type at 3 months, and 21% were seizure free. In the GRAD-KD protocol, 67% had a >50% reduction at 3 months, and 21% were seizure free. The two protocols were equivalent in efficacy (p = 0.033). At 3 months, the FAST-KD median percentage seizure reduction rate was 78% (ranging from 100% reduction to 73% increase in seizures per week) and was 94% (ranging from 100% reduction to 161% increase in seizures per week) for the GRAD-KD protocol. By using a logarithmic transformed percentage reduction rate and an equivalence limit

  16. Safety/Tolerability and efficacy of rivastigmine in taiwanese patients with Alzheimer's disease: a prospective post-marketing surveillance study.

    PubMed

    Chiu, Pai-Yi; Dai, Dao-En; Hsu, Hai-Pei; Lee, Chao; Lin, Juei-Jueng; Kuo, Hung-Chou; Huang, Ying-Chih; Liu, Yung-Chang; Tsai, Ching-Piao

    2009-01-01

    Rivastigmine is approved for the symptomatic treatment of mild to moderate dementia in patients with Alzheimer's disease. The drug was launched in Taiwan in 2000. The primary objective of this post-marketing surveillance (PMS) study was to describe the safety/tolerability of treatment with rivastigmine capsules in patients with Alzheimer's disease. The secondary objectives of this study were to define the optimal titration pattern, maintenance dose, efficacy and patient satisfaction with treatment with rivastigmine capsules. This was a prospective, non-interventional post-marketing observational study in patients who met the criteria for mild or moderate Alzheimer's disease. The primary outcome measure for this trial was the incidence of emerging adverse events. Dosages related to titration patterns and maintenance doses were summarized. Efficacy evaluations conducted using the Mini-Mental State Examination, Clinical Dementia Rating and modified Instrumental Activities of Daily Living scales were also primary outcome measures, and results are shown descriptively. The patients' therapeutic responses to rivastigmine and satisfaction with rivastigmine were secondary outcome measures. Therapeutic response and treatment satisfaction were summarized descriptively. A total of 264 patients were enrolled into the study. The mean duration of exposure to rivastigmine during the study was 151.1 days. Patients were taking rivastigmine 1.5-6 mg twice daily and the most frequent maintenance dose level was 4.5 mg twice daily. Among patients treated with rivastigmine, all primary and secondary outcome measures showed improvement or stabilization of cognition and global functioning. Of the 253 safety analysis patients, 155 patients (61.3%) reported at least one adverse event. The most frequent adverse events by system organ class were psychiatric disorders (9.1%) and gastrointestinal disorders (8.3%). The most common adverse events observed were dizziness (5.5%), insomnia (5

  17. A prospective randomized study of the efficacy of "Turning Point," an inpatient violence intervention program.

    PubMed

    Loveland-Jones, Catherine; Ferrer, Lucas; Charles, Scott; Ramsey, Frederick; van Zandt, Andrea; Volgraf, Jill; Santora, Thomas; Pathak, Abhijit; Dujon, Jay; Sjoholm, Lars; Rappold, Joseph; Goldberg, Amy

    2016-11-01

    From 2002 to 2011, there were more than 17,000 shootings in Philadelphia. "Turning Point," Temple University Hospital's inpatient violence intervention program, takes advantage of the teachable moment that occurs after violent injury. In addition to receiving traditional social work services, Turning Point patients watch their trauma bay resuscitation video and a movie about violence, meet with a gunshot wound survivor and an outpatient case manager, and also undergo psychiatric assessment. The purpose of this study was to determine the efficacy of Turning Point in changing attitudes toward guns and violence among victims of penetrating trauma. This prospective randomized study was conducted from January 2012 to January 2014. Patients who sustained a gunshot or stab wound were randomized to standard of care, which involved traditional social work services only, or Turning Point. The Attitudes Toward Guns and Violence Questionnaire was administered to assess attitude change. Analysis was performed with repeated-measures analysis of variance. A p < 0.05 was significant. A total of 80 of a potential 829 patients completed the study (40 standard of care, 40 Turning Point). The most common reason for exclusion was anticipated length of stay being less than 48 hours. The two groups were similar with respect to most demographics. Unlike the standard-of-care group, the Turning Point group demonstrated a 50% reduction in aggressive response to shame, a 29% reduction in comfort with aggression, and a 19% reduction in overall proclivity toward violence. Turning Point is effective in changing attitudes toward guns and violence among victims of penetrating trauma. Longer follow-up is necessary to determine if this program can truly be a turning point in patients' lives. Therapeutic/care management study, level II.

  18. Randomized prospective evaluation of adjuvant hyaluronic acid therapy administered after knee arthroscopy.

    PubMed

    Westrich, Geoffrey; Schaefer, Sarah; Walcott-Sapp, Sarah; Lyman, Stephen

    2009-12-01

    Intra-articular injections of hyaluronic acid products may eliminate pain, improve mobility and quality of life, and delay osteoarthritis progression. In this study, we evaluated the safety and efficacy of sodium hyaluronate injections given after knee arthroscopy. Forty-six patients with early osteoarthritis and a symptomatic meniscus tear were prospectively randomized into study (injection) and control groups and underwent knee arthroscopy. Study patients received 3 sodium hyaluronate injections after surgery. Study and control outcomes were compared 3 and 6 months after surgery. The injection patients had significantly less pain (visual analog scale) at 3-month follow-up and more flexion at 6-month follow-up. Tenderness, pain on motion, and crepitus were significantly more likely to be absent from injection patients at the 3- and 6-month follow-ups. Patients with osteoarthritis and a symptomatic meniscus tear may experience more pain relief and functional mobility after arthroscopic surgery plus hyaluronic acid injections than after arthroscopy alone.

  19. Efficacy of Synbiotics in Patients with Slow Transit Constipation: A Prospective Randomized Trial

    PubMed Central

    Ding, Chao; Ge, Xiaolong; Zhang, Xueying; Tian, Hongliang; Wang, Hongkan; Gu, Lili; Gong, Jianfeng; Zhu, Weiming; Li, Ning

    2016-01-01

    Synbiotic intake may efficiently restore the balance of gut microbiota and improve gastrointestinal functions. The aim of the study was to evaluate the efficacy of a synbiotic in patients with slow transit constipation. A total of 100 patients with slow transit constipation were randomized to receive either a synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoints were the clinical remission and improvement rates at weeks 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, patient assessment of constipation symptoms, gastrointestinal quality-of-life index scores, satisfaction scores, and adverse events were also monitored. The clinical remission rates reached 37.5% at week 4 and 45.8% at week 12 in the treatment group, compared to 13.3% at week 4 and 16.7% at week 12 in the placebo group (p < 0.01 for both comparisons). Over 12 weeks, 64.6% of the patients who received the synbiotic experienced clinical improvement, compared to 29.2% of the patients in the placebo group (p < 0.01). During the intervention period, patients who were treated with the synbiotic exhibited increased stool frequency, improved stool consistency, decreased CTT, and improved constipation-related symptoms. This randomized, placebo-controlled trial suggested that dietary supplementation with a synbiotic improved evacuation-parameters-associated symptoms and colonic motility in patients with slow transit constipation (STC). PMID:27690093

  20. Efficacy of Synbiotics in Patients with Slow Transit Constipation: A Prospective Randomized Trial.

    PubMed

    Ding, Chao; Ge, Xiaolong; Zhang, Xueying; Tian, Hongliang; Wang, Hongkan; Gu, Lili; Gong, Jianfeng; Zhu, Weiming; Li, Ning

    2016-09-28

    Synbiotic intake may efficiently restore the balance of gut microbiota and improve gastrointestinal functions. The aim of the study was to evaluate the efficacy of a synbiotic in patients with slow transit constipation. A total of 100 patients with slow transit constipation were randomized to receive either a synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoints were the clinical remission and improvement rates at weeks 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, patient assessment of constipation symptoms, gastrointestinal quality-of-life index scores, satisfaction scores, and adverse events were also monitored. The clinical remission rates reached 37.5% at week 4 and 45.8% at week 12 in the treatment group, compared to 13.3% at week 4 and 16.7% at week 12 in the placebo group (p < 0.01 for both comparisons). Over 12 weeks, 64.6% of the patients who received the synbiotic experienced clinical improvement, compared to 29.2% of the patients in the placebo group (p < 0.01). During the intervention period, patients who were treated with the synbiotic exhibited increased stool frequency, improved stool consistency, decreased CTT, and improved constipation-related symptoms. This randomized, placebo-controlled trial suggested that dietary supplementation with a synbiotic improved evacuation-parameters-associated symptoms and colonic motility in patients with slow transit constipation (STC).

  1. The Efficacy of Shielding Systems for Reducing Operator Exposure during Neurointerventional Procedures: A Real-World Prospective Study.

    PubMed

    Miller, T R; Zhuo, J; Jindal, G; Shivashankar, R; Beaty, N; Gandhi, D

    2017-03-01

    Neurointerventional surgery may expose patients and physician operators to substantial amounts of ionizing radiation. Although strategies for reducing patient exposure have been explored in the medical literature, there has been relatively little published in regards to decreasing operator exposure. The purpose of this study was to evaluate the efficacy of shielding systems in reducing physician exposure in a modern neurointerventional practice. Informed consent was obtained from operators for this Health Insurance Portability and Accountability Act-compliant, institutional review board-approved study. Operator radiation exposure was prospectively measured during 60 consecutive neurointerventional procedures from October to November 2013 using a 3-part lead shielding system. Exposure was then evaluated without lead shielding in a second 60-procedure block from April to May 2014. A radiation protection drape was randomly selected for use in half of the cases in each block. Two-way analysis of covariance was performed to test the effect of shielding systems on operator exposure while controlling for other covariates, including procedure dose-area product. Mean operator procedure dose was 20.6 μSv for the entire cohort and 17.7 μSv when using some type of shielding. Operator exposure significantly correlated with procedure dose-area product, but not with other covariates. After we adjusted for procedure dose-area product, the use of lead shielding or a radiation protection drape significantly reduced operator exposure by 45% (F = 12.54, P < .0001) and 29% (F = 7.02, P = .009), respectively. The difference in protection afforded by these systems was not statistically significant (P = .46), and their adjunctive use did not provide additional protection. Extensive lead shielding should be used as much as possible in neurointerventional surgery to reduce operator radiation exposure to acceptable levels. A radiation protection drape is a reasonable alternative when

  2. Characterization, sensorial evaluation and moisturizing efficacy of nanolipidgel formulations.

    PubMed

    Estanqueiro, M; Conceição, J; Amaral, M H; Sousa Lobo, J M

    2014-04-01

    Nanostructured lipid carriers (NLC) have been widely studied for cosmetic and dermatological applications due to their favourable properties that include the formation of an occlusive film on the skin surface that reduces the transepidermal water loss (TEWL) and increase in water content in the skin which improves the appearance on healthy human skin and reduces symptoms of some skin disorders like eczema. The main objective of this study was the development of semisolid formulations based NLC with argan oil or jojoba oil as liquid lipids, by addition of Carbopol®934 or Carbopol®980 as gelling agents, followed by comparison between instrumental analysis and sensorial evaluation and in vivo efficacy evaluation. Nanostructured lipid carriers dispersions were produced by the ultrasound technique, and to obtain a semisolid formulation, gelling agents were dispersed in the aqueous dispersion. Particle size, polydispersity index and zeta potential were determined. Instrumental characterization was performed by rheological and textural analysis; the sensorial evaluation was also performed. Finally, skin hydration and TEWL were studied by capacitance and evaporimetry evaluation, respectively. Particles showed a nanometric size in all the analysed formulations. All the gels present pseudoplastic behaviour. There is a correspondence between the properties firmness and adhesiveness as determined by textural analysis and the sensory evaluation. The formulations that showed a greater increase in skin hydration also presented appropriate technological and sensorial attributes for skin application. Nanolipidgel formulations with the addition of humectants are promising systems for cosmetic application with good sensory and instrumental attributes and moisturizing efficacy.

  3. Evaluation with evoked and spontaneous electromyography during lumbar instrumentation: a prospective study.

    PubMed

    Welch, W C; Rose, R D; Balzer, J R; Jacobs, G B

    1997-09-01

    The neuroanatomical structures that approximate the bony pedicles of the lumbar spine allow little room for technical error or compromise of the bone during pedicle screw insertion. Currently available neurophysiological monitoring techniques detect compromised bone and nerve root injury after it occurs. The purpose of this prospective study is to evaluate the reliability and efficacy of a unique neurophysiological monitoring technique. This technique provides immediate evaluation of pedicle cortical bone integrity in patients undergoing lumbar fusion with instrumentation by using electrified surgical instruments throughout the pedicle screw fusion procedure. Spontaneous electromyographic (EMG) activity was also monitored. Intraoperative evoked EMG stimulation was performed using a pedicle probe and feeler as monopolar stimulators during the insertion of 164 pedicle bone screws in 32 patients. The EMG response to subthreshold stimulation intensities indicated cortical bone compromise. Immediate and conclusive feedback via evoked EMG activity using stimulating pedicle probes in appropriate muscle groups was successful in identifying pedicle cortical bone compromise in four patients. One false-negative evoked EMG study was noted but was identified via spontaneous EMG activity. Intraoperative EMG monitoring alerted the surgeon that redirection of the pedicle probe or screw was necessary to avoid nerve root irritation or injury and served as an early warning system. Evoked EMG stimulation proved to be reliable and efficacious, especially when used in combination with spontaneous EMG. This technique may provide an added safeguard during implant placement procedures at centers where intraoperative neurophysiological monitoring is routinely performed.

  4. Evaluating the effects of GP remuneration: problems and prospects.

    PubMed

    Scott, A; Hall, J

    1995-03-01

    General practice reform is occurring in a number of countries. Little is known, however, of the effects of remunerating general practitioners on the costs and outcomes of care. Valuable lessons can be learned for the scope and design of future research, however, from the existing literature on the effects of general practioner (GP) remuneration. The objectives of this paper are to highlight some of the problems and pitfalls that should be avoided in any further research on the effects of GP remuneration and to identify the main issues for future research. Eighteen studies of the effects of GP remuneration have been reviewed, with a focus on the methods used. Eight studies addressed the effect of changes in the level of remuneration, three evaluated the effect of special payments and bonuses and seven assessed the effects of different remuneration systems. Although there are often practical constraints on the choice of study design, crude 'before and after' analyses and the use of aggregate data should be avoided in favour of prospective evaluations using consultation-based data. The studies reviewed did not evaluate the effects of remuneration on patient welfare and were characterised by the omission of major confounding variables and an inability to generalise to other settings. These issues present a considerable challenge to researchers, GPs and policy makers.

  5. Efficacy evaluation of syringe pump developed for continuous drug infusion

    PubMed Central

    Jung, Bongsu; Seo, Kwang-Suk; Kwon, Suk Jin; Lee, Kiyoung; Hong, Suyong; Seo, Hyounsoon; Kim, Gi-Young; Park, Geun-Mook; Jeong, Juhee

    2016-01-01

    Background In dental intravenous sedation, continuous intravenous infusion of a low-dose drug requires an infusion pump such as a syringe pump. To develop a new syringe pump for clinical use, the functions of the pump must meet certain international standards. Various safety and efficacy tests must be performed on the syringe pump, as stipulated by these standards, and an approval must be received from the approving agency based on such test results. Methods The authors of the present study developed a novel syringe pump and performed efficacy evaluation by testing its infusion speed at 1 and 25 ml/h, and infusion performance testing at 2 and 24 h. Moreover, performance evaluation was conducted by comparing the novel pump to an existing pump with the infusion speed varied from 1 to 5 ml/h. Results In the efficacy testing on the newly developed syringe pump, infusion with the infusion speed initially set to 1 ml/h resulted in infusion speeds of 1.00 and 0.99 ml/h in the 2- and 24-h assessment, respectively. Changing the infusion speed setting to 25 ml/h resulted in an infusion speed of 25.09 and 23.92 ml/h in the 2- and 24-h assessment, respectively. These results show no significant differences when compared with other commercially available pumps. Conclusions The efficacy testing of the newly developed syringe pump showed the accuracy to be within tolerance. Based on these findings, we believe that the newly developed syringe pump is suitable for clinical use. PMID:28879319

  6. Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort.

    PubMed

    Gecse, Krisztina B; Lovász, Barbara D; Farkas, Klaudia; Banai, János; Bene, László; Gasztonyi, Beáta; Golovics, Petra Anna; Kristóf, Tünde; Lakatos, László; Csontos, Ágnes Anna; Juhász, Márk; Nagy, Ferenc; Palatka, Károly; Papp, Mária; Patai, Árpád; Lakner, Lilla; Salamon, Ágnes; Szamosi, Tamás; Szepes, Zoltán; Tóth, Gábor T; Vincze, Áron; Szalay, Balázs; Molnár, Tamás; Lakatos, Péter L

    2016-02-01

    Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  7. Central venous access for haemodialysis: prospective evaluation of possible complications.

    PubMed

    de Andrade, Denise; Ferreira, Viviane

    2007-02-01

    The combination of chronic renal insufficiency and haemodialysis represents a challenge for health professionals. Chronic renal insufficiency patients undergoing haemodialysis treatment through a temporary double-lumen catheter were prospectively studied in order to identify the type and frequency of local and systemic complications. A six-month period was established with a view to the inclusion of new cases. Data were acquired through interviews, clinical assessment and patient records, and entered into a Microsoft Excel database through a double entry system and exported to the Statistical Package Social Sciences software. Sixty-four patients were evaluated prospectively, of which thirty-eight (59.4%) were men and 35 (54.7%) required catheter insertion for immediate treatment. During the study period, 145 catheters were inserted, ranging from 1 to 7 implants per patient, 29 (45.3%) were single insertions and 127 (87.6%) catheters were inserted into the jugular vein. The catheters were left in place for an average of 30 days. Forty-one (64%) presented inadequate functioning, after about 26 days. A febrile state occurred in 24 (37.5%) patients after 34 days, secretion at the catheter entry site in 27 (42.2% after 26 days and bloodstream infection was encountered in 34(53%) after 34 days. Of the 61 blood culture samples, thirty (49%) were positive for Staphylococcus aureus that was the microorganism most frequently isolated. The findings indicate worrying aspects such as the catheters permanence time, exposing patients to different complications, including infection. Furthermore, inadequate catheter functioning leads to inefficient haemodialysis treatment. Knowledge about complications allows for systematic care planning, prevention and control actions.

  8. G6PD Deficiency and Antimalarial Efficacy for Uncomplicated Malaria in Bangladesh: A Prospective Observational Study

    PubMed Central

    Ley, Benedikt; Alam, Mohammad Shafiul; Thriemer, Kamala; Hossain, Mohammad Sharif; Kibria, Mohammad Golam; Auburn, Sarah; Poirot, Eugenie; Price, Ric N.; Khan, Wasif Ali

    2016-01-01

    Background The Bangladeshi national treatment guidelines for uncomplicated malaria follow WHO recommendations but without G6PD testing prior to primaquine administration. A prospective observational study was conducted to assess the efficacy of the current antimalarial policy. Methods Patients with uncomplicated malaria, confirmed by microscopy, attending a health care facility in the Chittagong Hill Tracts, Bangladesh, were treated with artemether-lumefantrine (days 0–2) plus single dose primaquine (0.75mg/kg on day2) for P. falciparum infections, or with chloroquine (days 0–2) plus 14 days primaquine (3.5mg/kg total over 14 days) for P. vivax infections. Hb was measured on days 0, 2 and 9 in all patients and also on days 16 and 30 in patients with P. vivax infection. Participants were followed for 30 days. The study was registered with the clinical trials website (NCT02389374). Results Between September 2014 and February 2015 a total of 181 patients were enrolled (64% P. falciparum, 30% P. vivax and 6% mixed infections). Median parasite clearance times were 22.0 (Interquartile Range, IQR: 15.2–27.3) hours for P. falciparum, 20.0 (IQR: 9.5–22.7) hours for P. vivax and 16.6 (IQR: 10.0–46.0) hours for mixed infections. All participants were afebrile within 48 hours, two patients with P. falciparum infection remained parasitemic at 48 hours. No patient had recurrent parasitaemia within 30 days. Adjusted male median G6PD activity was 7.82U/gHb. One male participant (1/174) had severe G6PD deficiency (<10% activity), five participants (5/174) had mild G6PD deficiency (10–60% activity). The Hb nadir occurred on day 2 prior to primaquine treatment in P. falciparum and P. vivax infected patients; mean fractional fall in Hb was -8.8% (95%CI -6.7% to -11.0%) and -7.4% (95%CI: -4.5 to -10.4%) respectively. Conclusion The current antimalarial policy remains effective. The prevalence of G6PD deficiency was low. Main contribution to haemolysis in G6PD normal

  9. Utility of Gram's stain and efficacy of quantitative cultures for posttraumatic pneumonia: a prospective study.

    PubMed Central

    Croce, M A; Fabian, T C; Waddle-Smith, L; Melton, S M; Minard, G; Kudsk, K A; Pritchard, F E

    1998-01-01

    OBJECTIVE: This prospective trial examined the efficacy of using bronchoalveolar lavage (BAL) for the diagnosis of pneumonia (PN) and the utility of Gram's stain (GS) for dictating empiric therapy. SUMMARY BACKGROUND DATA: Posttraumatic nosocomial PN remains a significant cause of morbidity and mortality. However, its diagnosis is elusive, especially in multiply injured patients. The systemic inflammatory response syndrome of fever, leukocytosis, and a hyperdynamic state is common in trauma patients, especially patients with pulmonary contusion. Bronchoscopy with BAL with quantitative cultures of the lavage effluent may distinguish between PN and systemic inflammatory response syndrome, and GS of the lavage effluent may guide empiric therapy before quantitative culture results. METHODS: Mechanically ventilated trauma patients with a clinical diagnosis of PN (fever, leukocytosis, purulent sputum, and new or changing infiltrate on chest radiograph) underwent bronchoscopy with BAL. Effluent was sent for GS and quantitative cultures. The diagnostic threshold for PN was > or =10(5) colony-forming units (CFU)/mL, and antibiotics were continued. Antibiotics were stopped for < 10(5) CFU/mL and the diagnosis of systemic inflammatory response syndrome was made. Causative organisms for PN were compared to GS. RESULTS: Over a 2-year period, 232 patients underwent 443 bronchoscopies with BAL (71% men, 29% women; mean age, 41). The mean injury severity score was 30. Sixty percent of the patients had pulmonary contusion, and 59% were cigarette smokers. The overall incidence of PN was 39% and was no different regardless of the number of BALs a patient had. The false-negative rate of BAL was 7%. GS identified gram-positive organisms in 80% of patients with gram-positive PN and 40% of patients with gram-negative PN. GS identified gram-negative organisms in 52% of patients with gram-positive PN and 77% with gram-negative PN. The duration of the intensive care unit stay relative to

  10. Prospective evaluation of syndesmotic ankle sprains without diastasis.

    PubMed

    Nussbaum, E D; Hosea, T M; Sieler, S D; Incremona, B R; Kessler, D E

    2001-01-01

    Sixty consecutive collegiate athletes with "high" ankle symptoms were prospectively evaluated over a 3-year period in an effort to better define this debilitating ankle injury. All athletes included in this study had tenderness over the distal anterior tibiofibular ligament, tenderness proximally along the interosseous membrane, and functional disability. No study subject had a fracture or frank tibia-fibula diastasis. The severity of the sprain was quantified using the interosseous "tenderness length." A standard rehabilitation protocol was followed by all patients. Athletes returned to competition when they could perform all functional testing without difficulty. Time to return to full competitive activity averaged 13.4 days. The number of days missed from competition was statistically related to the interosseous tenderness length (P = 0.0001) and to positive results on the squeeze test (P = 0.03). Fifty-three of the 60 injured athletes were evaluated at least 6 months after injury. Patients rated their outcomes as good or excellent. Six of the patients experienced occasional ankle pain and stiffness, four patients reported recurrent ankle sprains, and one patient had heterotopic ossification formation.

  11. Anesthetic efficacy of 4% articaine versus 2% lignocaine during the surgical removal of the third molar: A comparative prospective study

    PubMed Central

    Jain, Nikil Kumar; John, Reena Rachel

    2016-01-01

    Aim: The study aimed at evaluating the clinical efficacy of articaine over lidocaine in the surgical removal of impacted mandibular third molars. Objective: The objectives were to compare the onset of anesthesia, pain during injection, during the procedure and after the procedure, compare the duration of anesthesia, and need for re-anesthesia. Materials and Methods: A prospective study was conducted on 70 subjects planned for surgical removal of mandibular third molars. Subjects were randomly administered one of two local anesthetics. The anesthetic agent used was unknown for the patient and the observer who performed the measurements. Results: The differences in latency with 4% articaine (56.57 ± 9.8 s) and with 2% lignocaine (88.26 ± 12.87 s), pain during procedure for articaine 1.31 ± 0.87 and for lignocaine 2.60 ± 1.06, pain after procedure was 0.89 ± 0.58 for articaine and 1.31 ± 1.05 for lignocaine, and mean duration of anesthetic effect for articaine was 231 ± 57.15 min and 174.80 ± 37.02 min for lignocaine, which was statistically significant. For re-anesthesia, 6 out of 35 patients needed re-anesthesia at the frequency of 8.57% for articaine and 13 out of 35 patients needed re-anesthesia at a frequency of 18.57% for lignocaine. Conclusion: The results proved that articaine had a significant faster onset of action and longer duration of action when compared to lignocaine. Hence, the pain experienced by the patients during and after the surgical procedure was significantly less. The study was concluded that articaine is a safe alternative to lignocaine, which is potent and effective in minor surgical procedures such as removal of mandibular third molars. PMID:27212774

  12. A prospective study of the safety and efficacy of frameless, pinless electromagnetic image-guided biopsy of cerebral lesions.

    PubMed

    Harrisson, Stuart E; Shooman, David; Grundy, Paul L

    2012-03-01

    In recent years, frameless navigation techniques have been reported to be safe and effective for biopsy of cerebral lesions. To evaluate the safety and efficacy of a technique of frameless, pinless electromagnetic-guided biopsy for brain lesions with the Medtronic Stealth AxiEM. Prospective data were collected on consecutive brain biopsies performed by a single surgeon (P.L.G.) with this technology between October 2007 and May 2010. One trajectory was made per lesion with multiple specimens taken for analysis. Outcome measures included measures of accuracy, histological yield, and complication rate. A total of 150 biopsies were performed in 149 patients (84 male and 65 female patients; age range, 19.8-83.8 years). The consultant performed 49 procedures, supervising a trainee in the others. In only 1 case (0.7%) was there nondiagnosis consequent of a registration error and inaccurate trajectory. In 4 other cases (2.7%), no specific diagnosis was established, but abnormal tissue was identified histologically, and postoperative imaging confirmed accurate targeting of these lesions. There were no instances of intracranial hemorrhage or significant morbidity and no deaths directly attributable to the procedure. Four patients (2.7%) died within 30 days of the procedure but not of complications of surgery. One patient suffered a transitory neurological deficit. Electromagnetic navigation is proven to be a simple, safe, and effective innovation for frameless and pinless biopsy of cerebral lesions. This technique is time efficient, and elimination of frame placement enhances patient comfort and facilitates the use of local anesthetic technique.

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

    PubMed Central

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

    2015-01-01

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

  14. Evaluation of the efficacy of two leishmanins in asymptomatic dogs.

    PubMed

    Solano-Gallego, L; Llull, J; Arboix, M; Ferrer, L; Alberola, J

    2001-12-03

    There are few studies in dogs concerning leishmanin skin test. We evaluated and compared the efficacy of two leishmanin preparations for the detection of dog Leishmania cellular-mediated immunity. Clinically healthy dogs living in an endemic area were studied. A leishmanin preparation 1 (3 x 10(8) promastigotes/ml) was superior to a leishmanin preparation 2 (5 x 10(6) promastigotes/ml), measured as the percentage of positive reactions and the diameter of the induced induration. The leishmanin skin test is a valuable tool, although the results show that the degree of response, as it has been shown in human beings, depends on the preparation used.

  15. Characterization of Mathematics Instructional Practises for Prospective Elementary Teachers with Varying Levels of Self-Efficacy in Classroom Management and Mathematics Teaching

    ERIC Educational Resources Information Center

    Lee, Carrie W.; Walkowiak, Temple A.; Nietfeld, John L.

    2017-01-01

    The purpose of this study was to investigate the relationship between prospective teachers' (PTs) instructional practises and their efficacy beliefs in classroom management and mathematics teaching. A sequential, explanatory mixed-methods design was employed. Results from efficacy surveys, implemented with 54 PTs were linked to a sample of…

  16. Turkish Prospective Middle School Mathematics Teachers' Beliefs and Perceived Self-Efficacy Beliefs Regarding the Use of Origami in Mathematics Education

    ERIC Educational Resources Information Center

    Arslan, Okan; Isiksal-Bostan, Mine

    2016-01-01

    The purpose of this study was to investigate beliefs and perceived self-efficacy beliefs of Turkish prospective elementary mathematics teachers in using origami in mathematics education. Furthermore, gender differences in their beliefs and perceived self-efficacy beliefs were investigated. Data for the current study was collected via Origami in…

  17. Turkish Prospective Middle School Mathematics Teachers' Beliefs and Perceived Self-Efficacy Beliefs Regarding the Use of Origami in Mathematics Education

    ERIC Educational Resources Information Center

    Arslan, Okan; Isiksal-Bostan, Mine

    2016-01-01

    The purpose of this study was to investigate beliefs and perceived self-efficacy beliefs of Turkish prospective elementary mathematics teachers in using origami in mathematics education. Furthermore, gender differences in their beliefs and perceived self-efficacy beliefs were investigated. Data for the current study was collected via Origami in…

  18. 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

  19. Therapeutic efficacy of artemether-lumefantrine for Plasmodium vivax infections in a prospective study in Guyana

    PubMed Central

    2012-01-01

    Background In Guyana, chloroquine + primaquine is used for the treatment of vivax malaria. A worldwide increase of chloroquine resistance in Plasmodium vivax led to questioning of the current malaria treatment guidelines. A therapeutic efficacy study was conducted using artemether-lumefantrine + primaquine against P. vivax to evaluate a treatment alternative for chloroquine. Methods From 2009 to 2010, a non-controlled study in two hospitals in Guyana was conducted. A total 61 patients with P. vivax infection were treated with artemether-lumefantrine as a six-dose regimen twice a day for three days with additional 0.25 mg/kg/d primaquine at day 0 for 14 days. Clinical and parasitological parameters were followed on days 0,1,2,3,7,14 and 28 in agreement with WHO guidelines. Plasmodium vivax DNA from eight patients was analysed for pvmdr1, molecular marker of resistance. Results Artemether-lumefantrine cleared 100% of parasites on day 1, but two patients (3%) had recurrence of parasites on day 28, suggesting relapse. No pvmdr1 Y976F polymorphism was detected. The treatment regimen was well tolerated. Conclusions In Guyana, artemether-lumefantrine represents an adequate treatment option against P. vivax when combined with primaquine. Availability of this alternative will be of great importance in case of emerging chloroquine resistance against P. vivax. PMID:23083017

  20. Teacher Leadership and Teacher Efficacy: A Correlational Study Comparing Teacher Perceptions of Leadership and Efficacy and Teacher Evaluation Scores from the North Carolina Educator Evaluation System

    ERIC Educational Resources Information Center

    Guenzler, April M.

    2016-01-01

    This study sought to identify correlations between constructs of teacher leadership, teacher efficacy, and teacher evaluation. Teacher perceptual data of support of teacher leadership, perceptual data on personal teacher efficacy, and teacher self-reported scores from the North Carolina Educator Evaluation System were gathered. The relationships…

  1. Self-Efficacy Perceptions of Prospective Social Studies Teachers in Relation to History Teaching

    ERIC Educational Resources Information Center

    Yilmaz, Ali

    2009-01-01

    Self-efficacy is one of the important concepts of the social cognitive theory, and can be defined as individual's perception of his or her own capabilities for organizing and successfully executing the courses of action required to attain designated types of performance. Teachers with high self-efficacy perception can contribute to creation of a…

  2. Exploring Prospective EFL Teachers' Perceived Self-Efficacy and Beliefs on English Language Learning

    ERIC Educational Resources Information Center

    Genç, Gülten; Kulusakli, Emine; Aydin, Savas

    2016-01-01

    Learners' perceived self-efficacy and beliefs on English language learning are important in education. Taking into consideration the important impact of individual variables on language learning, this study seeks to highlight the relationship between Turkish EFL learners' beliefs about language learning and their sense of self-efficacy. The…

  3. Comparative Analysis of Expectancies of Efficacy in In-Service and Prospective Teachers

    ERIC Educational Resources Information Center

    de la Torre Cruz, Manuel J.; Casanova Arias, Pedro F.

    2007-01-01

    This study examines the beliefs about effective teaching in student teachers and inservice teachers. We constructed a measurement composed of an adaptation in Spanish of the Gibson and Dembo's (1984. Teacher efficacy: A construct validation. "Journal of Educational Psychology", 76, 569-582). Teacher Efficacy Scale and of the items…

  4. Self-Efficacy Perceptions of Prospective Social Studies Teachers in Relation to History Teaching

    ERIC Educational Resources Information Center

    Yilmaz, Ali

    2009-01-01

    Self-efficacy is one of the important concepts of the social cognitive theory, and can be defined as individual's perception of his or her own capabilities for organizing and successfully executing the courses of action required to attain designated types of performance. Teachers with high self-efficacy perception can contribute to creation of a…

  5. Prospective evaluation of pregnant women with hypothyroidism: implications for treatment.

    PubMed

    Neto, Leonardo Vieira; De Almeida, Carla Amaral; Da Costa, Sheila Mamede; Vaisman, Mário

    2007-03-01

    Pregnancy is characterized by a series of maternal hormonal and metabolic changes which can affect thyroid function and the course of thyroid dysfunction in different ways. Moreover, hypothyroidism is also associated with obstetric complications and morbidity to the fetus. The aim of the present study was to evaluate the influence of hypothyroidism during the course of pregnancy and the necessity of adjusting the dose of levothyroxine. We prospectively followed 16 patients with previous diagnosis of hypothyroidism. In ten patients (62.5%) it was necessary to raise the dose of levothyroxine, with a median increase of 20.7%. One pregnancy was complicated by premature amniorrhexis and two by pre-eclampsia. The screening for congenital hypothyroidism was negative in all newborns. We conclude that it is very important to offer screening to high-risk patients who wish to become pregnant. Dose adjustment based on serum levels of thyroid-stimulating hormone (TSH) is essential. In patients in whom TSH is not measured during the first weeks of pregnancy, a good approach could be to increase the dose of replacement therapy by 20-25% to avoid hypothyroidism.

  6. Thrombotic complications of implanted central venous access devices: prospective evaluation.

    PubMed

    Labourey, Jean-Luc; Lacroix, Philippe; Genet, Dominique; Gobeaux, François; Martin, Jean; Venat-Bouvet, Laurence; Lavau-Denes, Sandrine; Maubon, Antoine; Tubiana-Mathieu, Nicole

    2004-05-01

    Implanted venous access devices (IVAD) are routinely used in oncologic patients. Thrombotic complication is a source of morbidity. During one year 246 patients with different solid neoplastic diseases received IVAD for chemotherapy administration. Two hundred forty-nine IVAD were placed percutaneously or by surgical cutdown. IVAD were flushed immediately after implantation with 3-5 mL of heparinized saline (100 U/mL). No monthly flush was required. A prospective evaluation of thrombotic complications was realised. in event of catheter dysfunction and/or clinical symptoms of phlebitis, a catheter opacification and/or a Doppler ultrasonography were performed. Twenty-three catheter dysfunctions were noted, corresponding to 13 catheter occlusions. Twelve patients presented clinical symptoms of phlebitis. Eleven venous thrombosis were diagnosed in this group; 10 by echo-Doppler and one by scanography. A unvaried statistic analysis using Fisher's test was performed to detect risk factors. Two factors were identified: the position of catheter tip above T4 (p < 0.001) and mediastinal or cervical lymph nodes larger than 6 cm (p < 0.001). The first increased the risk of catheter occlusion and the second increased the risk of phlebitis.

  7. Prospective evaluation of luteal phase length and natural fertility.

    PubMed

    Crawford, Natalie M; Pritchard, David A; Herring, Amy H; Steiner, Anne Z

    2017-03-01

    To evaluate the impact of a short luteal phase on fecundity. Prospective time-to-pregnancy cohort study. Not applicable. Women trying to conceive, ages 30-44 years, without known infertility. Daily diaries, ovulation prediction testing, standardized pregnancy testing. Subsequent cycle fecundity. Included in the analysis were 1,635 cycles from 284 women. A short luteal phase (≤11 days including the day of ovulation) occurred in 18% of observed cycles. Mean luteal phase length was 14 days. Significantly more women with a short luteal phase were smokers. After adjustment for age, women with a short luteal phase had 0.82 times the odds of pregnancy in the subsequent cycle immediately following the short luteal phase compared with women without a short luteal phase. Women with a short luteal length in the first observed cycle had significantly lower fertility after the first 6 months of pregnancy attempt, but at 12 months there was no significant difference in cumulative probability of pregnancy. Although an isolated cycle with a short luteal phase may negatively affect short-term fertility, incidence of infertility at 12 months was not significantly higher among these women. NCT01028365. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  8. Efficacy of EZStep in the management of plantar fasciitis: a prospective, randomized study.

    PubMed

    Al-Bluwi, Mohammed T; Sadat-Ali, Mir; Al-Habdan, Ibrahim M; Azam, Mohammed Q

    2011-08-01

    Plantar fasciitis is one of the most common causes of heel pain. Despite extensive efforts foot surgeons continue to debate the best modality of treatment. Analgesics, shoe inserts, stretching exercises, steroid injection, night splints, and extracorporeal shock wave therapy have proved effective in one group but fail in others. This study evaluated the efficacy of EZStep, a new foot brace for the management of plantar fasciitis. A total of 198 patients were randomized in 2 groups; group 1 (study group) received nonsteroidal anti-inflammatory drugs (NSAIDs; 4-6 weeks) and EZStep whereas group 2 (control group) received either NSAID and physiotherapy alone (2A) or NSAID, physiotherapy, and local steroid injection (2B). None of the patients received over-the-counter insoles or strapping of plantar arch to avoid any bias in randomization. Evaluations included measurement of weight and height, visual analog scale (VAS) for pain, and Short-Form McGill Pain Questionnaire (SFMPQ). After 8 weeks, patients were reevaluated, and assessment for the VAS and SFMPQ with treatment outcome was performed. Patients with VAS scores ≤3 were considered as excellent, ≥4 as good, and ≥7 as poor. The posttreatment evaluation showed that VAS scores were in the range from 2.97 ± 1.06 to 7.64 ± 2.9 (2A), P = .001, 95% confidence interval (CI) <-4.104; for 2B P = .001, CI <-2.44, and SFMPQ was 21.7 ± 4.5 and 69.2 ± 5.8 (group 2A; P = .001, 95% CI <-46.44). Compared with group 2B the SFMPQ was 66.5 ± 4.3 (P = .001, 95% CI <-30.720). In group 1 as per VAS, 86 (73.5%) were evaluated as excellent, 15 (12.8%) as good, and 16 (13.6%) as poor. Our study shows that the regular use of EZStep with short course of NSAIDs (4-6 weeks) was effective in ameliorating symptoms in more than 85% of patients suffering from plantar fasciitis.

  9. A prospective two-armed trial assessing the efficacy and performance of a silver dressing used postoperatively on high-risk, clean surgical wounds.

    PubMed

    Schwartz, Jamie; Goss, Selena; Facchin, Federico; Manizate, Fotini; Gendics, Cynthia; Braitman, Elissa; Lantis, John

    2014-04-01

    Surgical site infections (SSI) are a known complication of surgery. Silver-containing wound treatments are popular, despite the lack of evidence of SSI reduction. A two-armed study was conducted between July 2007 and November 2008 to evaluate the efficacy and ease of use of a postoperative silver dressing. In the first arm of the study, patients undergoing clean general, vascular, orthopedic, and neurosurgical procedures were allocated to receive a postoperative silver dressing (POSD) or a standard dressing of nonstick gauze under a fluid occlusive dressing. Outcome variables included the incidence of antibiotic initiation for SSI, clinical signs of infection, and leukocyte counts. The second arm of the study was a prospective case series designed to evaluate the performance and handling characteristics of the POSD. Onehundred- ninety-nine (199) patients (mean age 59.2 [range 21-94] years) were enrolled in the first arm of the study. Three out of 99 (3%) patients in the POSD and six out of 100 (6%) control group patients received antibiotic therapy for SSI (P = 0.498). Differences in the percentage of patients with clinical signs of infection following surgery also were not statistically significant (POSD: n = 24, 24.2%; control: n = 30, 30%; P = 0.426). In the second arm, 34 out of 36 patients rated the study dressing easy to apply in (94%), and no pain on removal was noted in 38 out of 57 (66.7%) assessments. No patients in the dressing performance cohort developed an SSI. Prospective, randomized, controlled clinical studies with large sample sizes are warranted to evaluate the efficacy and cost-effectiveness of the POSD.

  10. Efficacy of granulocyte and monocyte apheresis for antibiotic-refractory pouchitis after proctocolectomy for ulcerative colitis: an open-label, prospective, multicentre study

    PubMed Central

    Yamamoto, Takayuki; Tanaka, Toshiaki; Yokoyama, Tadashi; Shimoyama, Takahiro; Ikeuchi, Hiroki; Uchino, Motoi; Watanabe, Toshiaki

    2016-01-01

    Background: Granulocyte and monocyte apheresis (GMA) has shown therapeutic efficacy in active ulcerative colitis (UC). We thought that in patients with pouchitis after proctocolectomy for UC, GMA might produce immunological effects in the intestinal mucosa, and improve clinical symptoms. This prospective study was to evaluate the efficacy of GMA for antibiotic-refractory pouchitis after proctocolectomy for UC. Methods: A total of 13 patients with pouchitis disease activity index (PDAI) > 7 unresponsive to 2 weeks of antibiotic therapy were included. All patients received 10 GMA sessions at 2 sessions/week over 5 consecutive weeks. The primary endpoints were response (a decrease of ⩾3 points in the PDAI) and remission (PDAI < 4). Secondary endpoints included reduction of white blood cells (WBCs), C-reactive protein (CRP), faecal markers (calprotectin and lactoferrin), reduction of the PDAI endoscopic subscore, and GMA safety. Results: The median PDAI score was significantly decreased from 11 (range, 9–15) at entry to 9 (range, 6–13) after the GMA therapy (p = 0.02). A total of six patients (46%) responded to the treatment, but none achieved remission. The median endoscopic subscore (maximum: 6) was 5 (range, 4–6) at entry and 5 (range, 1–6) after the treatment (p = 0.10). None of the laboratory markers (WBCs, CRP, faecal calprotectin and lactoferrin) significantly changed during the treatment. Transient adverse events (AEs) were observed in two patients (15%), dyspnoea in one and headache in one. The AEs were not serious, and all patients completed the 10 GMA sessions. Conclusions: GMA has a good safety profile, but its efficacy appears to be limited in the management of chronic refractory pouchitis. However, a large controlled study should be conducted to evaluate the efficacy of GMA therapy in patients with pouchitis at an earlier clinical stage, before the disease has become refractory to conventional medical therapy. PMID:28203278

  11. Evaluation of neurosensory disturbance following orthognathic surgery: a prospective study.

    PubMed

    Degala, Saikrishna; Shetty, Sujeeth Kumar; Bhanumathi, M

    2015-03-01

    The prospective study was to evaluate the incidence, type of neurosensory disturbance (NSD), grade its severity and monitor its recovery occurring in the lower lip and chin due to damage to inferior alveolar nerve following orthognathic surgery involving mandible. The study included 10 patients who have undergone sagittal split osteotomy, genioplasty, and anterior subapical osteotomy (ASO). All the patients examined preoperatively and post operatively 1 week, 1 and 6 months according to standardized test to clarify the subjective and objective neurosensory status of the injured nerve. Pin prick test, blunt test, two-point discrimator test, brush stoke direction, light touch test, warm and cold test were used bilaterally to lower lip and chin area. Seven patients underwent bilateral sagittal split osteotomy (BSSO) (70 %), one patient had BSSO with genioplasty (10 %), two patients had BSSO with ASO (20 %). During the operation none of the nerves were transectioned, in 60 % of patients nerve was not visible and in 40 % of patients nerve was seen in distal segment. 70 % of patients underwent setback, 30 % of patients underwent advancement. The subjective evaluation of the patients revealed the incidence of 90 % at 1 week, 30 % at 1 month, 20 % at 6 months and 10 % at 1 year post operatively. The altered sensation reported subjectively was hypoesthesia in 50 % of the patients, anaesthesia in 40 % of the patients. There was 100 % recovery in advancement cases and 93.5 % recovery in setback cases. There is a high incidence of NSD of the lower lip and chin after BSSO related to advancement, setback, intraoperative nerve encounter and surgical skill. However, recovery of sensation occurs with increasing frequency during the follow-up period. The clinical neurosensory tests are effective guides to study the neurosensory deficit.

  12. Evaluating efficacy of current lung cancer screening guidelines.

    PubMed

    Nemesure, Barbara; Plank, April; Reagan, Lisa; Albano, Denise; Reiter, Michael; Bilfinger, Thomas V

    2017-01-01

    Objective Current lung cancer screening criteria based primarily on outcomes from the National Lung Screening Trial may not adequately capture all subgroups of the population at risk. We aimed to evaluate the efficacy of lung cancer screening criteria recommended by the United States Preventive Services Task Force, Centers for Medicare and Medicaid Services, and the National Comprehensive Cancer Network in identifying known cases of lung cancer. Methods An investigation of the Stony Brook Cancer Center Lung Cancer Evaluation Center's database identified 1207 eligible, biopsy-proven lung cancer cases diagnosed between January 1996 and March 2016. Age at diagnosis, smoking history, and other known risk factors for lung cancer were used to determine the proportion of cases that would have met current United States Preventive Services Task Force, Centers for Medicare and Medicaid Services, and National Comprehensive Cancer Network eligibility requirements for lung cancer screening. Results Of the 1046 ever smokers in the study, 40% did not meet the National Lung Screening Trial age requirements, 20% did not have a ≥30 pack year smoking history, and approximately one-third quit smoking >15 years before diagnosis, thus deeming them ineligible for screening. Applying the United States Preventive Services Task Force, Centers for Medicare and Medicaid Services, and National Comprehensive Cancer Network eligibility criteria to the Stony Brook Cancer Center's Lung Cancer Evaluation Center cases, 49.2, 46.3, and 69.8%, respectively, would have met the current lung cancer screening guidelines. Conclusions The United States Preventive Services Task Force and Centers for Medicare and Medicaid Services eligibility criteria for lung cancer screening captured less than 50% of lung cancer cases in this investigation. These findings highlight the need to reevaluate the efficacy of current guidelines and may have major public health implications.

  13. Evaluation of Influenza Vaccination Efficacy: A Universal Epidemic Model

    PubMed Central

    Bazhan, Sergei I.

    2016-01-01

    By means of a designed epidemic model, we evaluated the influence of seasonal vaccination coverage as well as a potential universal vaccine with differing efficacy on the aftermath of seasonal and pandemic influenza. The results of the modeling enabled us to conclude that, to control a seasonal influenza epidemic with a reproduction coefficient R0 ≤ 1.5, a 35% vaccination coverage with the current seasonal influenza vaccine formulation is sufficient, provided that other epidemiology measures are regularly implemented. Increasing R0 level of pandemic strains will obviously require stronger intervention. In addition, seasonal influenza vaccines fail to confer protection against antigenically distinct pandemic influenza strains. Therefore, the necessity of a universal influenza vaccine is clear. The model predicts that a potential universal vaccine will be able to provide sufficient reliable (90%) protection against pandemic influenza only if its efficacy is comparable with the effectiveness of modern vaccines against seasonal influenza strains (70%–80%); given that at least 40% of the population has been vaccinated in advance, ill individuals have been isolated (observed), and a quarantine has been introduced. If other antiepidemic measures are absent, a vaccination coverage of at least 80% is required. PMID:27668256

  14. Prospective evaluation of ambulatory laser vaporization of the prostate for benign prostatic hyperplasia.

    PubMed

    Berquet, Gaetan; Corbel, Luc; Della Negra, Emmanuel; Huet, Romain; Trifard, François; Codet, Yann; Boulière, Fabien; Verhoest, Grégory; Vincendeau, Sébastien; Bensalah, Karim; Mathieu, Romain

    2015-07-01

    Photoselective vaporization of the prostate (PVP) is an alternative to transurethral resection of the prostate in the surgical treatment of benign prostatic hyperplasia (BPH). Our objective was to prospectively evaluate the feasibility, safety, and efficacy of ambulatory photoselective vaporization of the prostate for benign prostatic hyperplasia. We prospectively collected data of all consecutive patients who underwent ambulatory PVP with the Greenlight(®) laser 180-W XPS at two centers between May 2012 and June 2013. Patients' characteristics, perioperative data, postoperative outcomes, complications, and patient's satisfaction were evaluated. Successful ambulatory care procedure was defined as the ability to leave the hospital in the evening of the operation. The ambulatory procedure was intended in 134 patients. Mean age was 67 years. Mean prostate volume was 54 ml, and Median American Society Anesthesiologists (ASA) score was 2. Ambulatory procedure was successful in 121 patients (90%). At 3 months, International Prostate Symptom Score (7.3 ± 4.9), maximal urinary flow rate (20.8 ± 7.6 ml/s), postvoid residual urine (19.2 ± 71 ml), and quality of life (1.6 ± 1.4) were significantly improved (P < 0.001). Fourteen patients (10.5%) had complications that were all minor (Clavien ≤ 2). Two patients had to be readmitted to the hospital. The majority of patients (89%) were satisfied with ambulatory care. Failure to complete ambulatory procedure was mostly related to logistical problem (70% of the cases). Ambulatory PVP is feasible with functional results and complications comparable to that of traditional hospitalization. Ambulatory care yields high patient's satisfaction. © 2015 Wiley Periodicals, Inc.

  15. [Correlation between facial nerve functional evaluation and efficacy evaluation of acupuncture treatment for Bell's palsy].

    PubMed

    Zhou, Zhang-ling; Li, Cheng-xin; Jiang, Yue-bo; Zuo, Cong; Cai, Yun; Wang, Rui

    2012-09-01

    To assess and grade facial nerve dysfunction according to the extent of facial paralysis in the clinical course of acupuncture treatment for Bell's palsy, and to observe the interrelationship between the grade, the efficacy and the period of treatment, as well as the effect on prognosis. The authors employed the House-Brackmann scale, a commonly used evaluation scale for facial paralysis motor function, and set standards for eye fissure and lips. According to the improved scale, the authors assessed and graded the degree of facial paralysis in terms of facial nerve dysfunction both before and after treatment. The grade was divided into five levels: mild, moderate, moderately severe, severe dysfunction and complete paralysis. The authors gave acupuncture treatment according to the state of the disease without artificially setting the treatment period. The observation was focused on the efficacy and the efficacy was evaluated throughout the entire treatment process. Fifty-three cases out of 68 patients with Bell's palsy were cured and the overall rate of efficacy was 97%. Statistically significant differences (P<0.01) were perceived among the efficacy of five levels of facial nerve dysfunction. Efficacy was correlated with the damage level of the disease (correlation coefficient r=0.423, P<0.01). The course of treatment also extended with the severity of facial nerve dysfunction (P<0.01). Differences exist in patients with Bell's palsy in terms of severity of facial nerve dysfunction. Efficacy is reduced in correlation with an increase in facial nerve dysfunction, and the period of treatment varies in need of different levels of facial nerve dysfunction. It is highly necessary to assess and grade patients before observation and treatment in clinical study, and choose corresponding treatment according to severity of damage of the disease.

  16. Prospective evaluation of femoral head viability following femoral neck fracture

    SciTech Connect

    Binkert, B.; Kroop, S.A.; Nepola, I.V.; Grantham, A.S.; Alderson, P.O.

    1984-01-01

    The bone scans of 33 patients (pts) with recent subcapital fractures (fx) of the femur were evaluated prospectively to determine their value in predicting femoral head visability. Each of the 33 pts (ll men, 22 women, age range 30-92) had a pre-operative bone scan within 72 hrs of the fx (23 pts within 24 hrs). Anterior and posterior planar views of both hips and pinhole views (50% of pts) were obtained 2 hrs after administration of Tc-99m HDP. The femoral head was classified as perfused if it showed the same activity as the opposite normal side or if it showed only slightly decreased activity. Femoral heads showing absent activity were classified as nonperfused. Overall, 20 of the 33 pts showed a photopenic femoral head on the side of the fx. Only 2 pts showed increased activity at hte site of the fx. Internal fixation of the fx was performed in 23 pts, 12 of whom had one or more follow-up scans. Five of these 12 pts showed absent femoral head activity on their initial scan, but 2 showed later reperfusion. The other 7 pts showed good perfusion initially, with only 1 later showing decreased femoral head activity. The other 10 pts (7 of whom had absent femoral head activity) had immediate resection of the femoral head and insertion of a Cathcart prosthesis. The results suggest that femoral head activity seen on a bone scan in the immediate post-fx period is not always a reliable indicator of femoral head viability. Decreased femoral head activity may reflect, in part, compromised perfusion secondary to post-traumatic edema, with or without anatomic disruption of the blood supply.

  17. Post-liver transplantation sarcopenia in cirrhosis: a prospective evaluation.

    PubMed

    Tsien, Cynthia; Garber, Ari; Narayanan, Arvind; Shah, Shetal N; Barnes, David; Eghtesad, Bijan; Fung, John; McCullough, Arthur J; Dasarathy, Srinivasan

    2014-06-01

    Pre-transplant sarcopenia (reduced skeletal muscle mass) predicts poor outcome in cirrhosis. In contrast, whether muscle mass increases post-orthotopic liver transplantation (OLT) is not known and was studied prospectively. Consecutive patients who underwent a comprehensive nutritional evaluation in a liver transplant nutrition clinic were included. Core abdominal muscle area was measured on abdominal computed tomography obtained pre- and post-OLT. Age- and gender-based controls were used to define sarcopenia. Measures of body composition pre-transplant were correlated with computed tomography measurements. Predictors and clinical impact of post-OLT change in muscle area were examined. In three subjects post-OLT and three controls, expression of genes regulating skeletal muscle mass were quantified. During the study period, 53 patients (M:F 41:12; age 56.9 ± 7.5 years) were followed up after OLT for 19.3 ± 9 months. Five patients died and another five had acute graft rejection. Pre-OLT sarcopenia was present in 33 (66.2%). Pre-transplant clinical characteristics including Child's score, MELD score, and nutritional status or post-transplantation immunosuppression regimen did not predict post-transplant change in muscle mass. New onset post-OLT sarcopenia developed in 14 patients. Loss of muscle mass post-OLT increased risk of diabetes mellitus and a trend toward higher mortality. Skeletal muscle expression of myostatin was higher and that of ubiquitin proteasome proteolytic components lower post-OLT than in controls. Post-transplantation sarcopenia is common and could not be attributed to pre-transplant characteristics or the type or duration of post-OLT immunosuppression. Post-transplant sarcopenia contributes to adverse consequences and strategies targeting myostatin may be beneficial. © 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

  18. SECONDARILY INFECTED NON-STRUVITE UROLITHIASIS: A PROSPECTIVE EVALUATION

    PubMed Central

    de Cógáin, Mitra R.; Lieske, John C.; Vrtiska, Terri J.; Tosh, Pritish K.; Krambeck, Amy E.

    2014-01-01

    Purpose To characterize patients who form non-struvite stones associated with infection (secondarily infected calculi) and to define the bacteria associated with these. Materials and Methods Patients undergoing percutaneous nephrolithotomy were prospectively recruited. Medical records were reviewed and stones were analyzed using microCT and infrared spectroscopy. A fragment of each stone was sent for bacterial culture. Patients were categorized by stone culture results (SC+/−) and the presence of struvite (ST+/−). Fisher’s exact test was used for comparison of proportion. Sterility of intraoperative SC was established with independently collected controls. Results In total, 125 patients were enrolled: 24 SC+/ST−, 19 SC+/ST+ and 82 SC−/ST−. Proportions of patients with prior urologic surgery, diabetes, and immunodeficiency were similar between groups. Patients with neurogenic bladder were more likely to have SC+/ST+ stones or SC+/ST− stones than SC−/ST− stones (26% vs. 8% vs. 0%, respectively, p<0.01). Among patients with metabolic evaluations, hypocitraturia was found in 31.6% (6/19) SC+/ST− patients, 46.7% (7/15) SC+/ST+ patients, and 26.0% (19/73) of SC−/ST− patients (p=0.28). Approximately 40% of cultured organisms in the secondarily infected calculi possessed urease and another 40% citrate lyase activity. Conclusions Secondarily infected stones were detected in approximately 20% of this surgical cohort and may be more common than previously appreciated. Neurogenic bladder appeared to predispose patients to either struvite or secondarily infected stones. The role of bacterial infection in stone formation is unclear, but may include alteration of urinary components, acting as a nidus for crystallization, or inducing inflammation. PMID:25306481

  19. Prospective Evaluation of Acupuncture as Treatment for Glaucoma.

    PubMed

    Law, Simon K; Lowe, Starrie; Law, Samuel M; Giaconi, JoAnn A; Coleman, Anne L; Caprioli, Joseph

    2015-08-01

    To evaluate acupuncture as treatment for glaucoma. Prospective double-masked randomized crossover study. setting: Clinical practice. One eye per patient with primary open-angle glaucoma and stable intraocular pressure (IOP). Patients were randomized to receive 1 acupuncture series (12 sessions with either eye-related [eye-points] or non-eye-related [non-eye-points] acupoints) and then crossed over to receive the other series. IOP, blood pressure (BP), heart rate (HR), best-corrected visual acuity (BCVA), visual field (VF), optic disc and peripapillary retinal nerve fiber layer (RNFL) measurements, compliance, and adverse reactions. Probability to detect 3 mm Hg IOP difference between series was 90%. Twenty-two patients volunteered and 11 (50.0%) completed the study; 8 (36.4%) did not complete treatment owing to changes of health, moving away, lack of transportation, or family crisis; and 3(13.6%) were withdrawn owing to needle sensitivity or IOP elevation (8 mm Hg) in the contralateral eye. After an acupuncture session, mean IOP increased slightly with both eye-points (from 12.9 ± 1.8 mm Hg to 13.6 ± 2.0 mm Hg, P = .019) and non-eye-points (from 13.0 ± 1.5 mm Hg to 13.5 ± 1.7 mm Hg, P = .073) series. HR, diurnal IOP, and BCVA showed no statistically significant changes after 12 sessions of either series. Systolic and diastolic BP were reduced after 12 sessions of non-eye-points series (P = .040, P = .002, respectively). Optic disc, RNFL, and VF showed no statistically significant changes. Acupuncture has no overall effect on diurnal IOP or BCVA but may temporally increase the IOP immediately after a treatment session. BP is lowered by acupuncture with non-eye-points, but not with eye-points. Compliance and adverse event rates were low. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Efficacy of oleuropein against UVB irradiation: preliminary evaluation.

    PubMed

    Perugini, P; Vettor, M; Rona, C; Troisi, L; Villanova, L; Genta, I; Conti, B; Pavanetto, F

    2008-04-01

    Oleuropein, a phenolic compound derived from olive leaves and oil, is known to possess several biological properties, many of which may be attributed to its antioxidant and free radical-scavenging activities. Nevertheless, up to now, the cosmetic activity of this molecule has not been extensively investigated. The aim of this work was to evaluate the cosmetic properties of oleuropein against UVB-induced erythema. To this end, an emulsion and an emulgel containing oleuropein were prepared, applied and evaluated on healthy volunteers who had undergone UVB irradiation to investigate its protective and/or lenitive activity. Protective effect was assayed by application of topical preparations before irradiation and lenitive effect was evaluated after erythema induction. Vitamin E was used as the reference compound. Our study was carried out by using noninvasive techniques to assess specific skin parameters: barrier function, skin colour and microcirculation. Results clearly showed that oleuropein formulations highlighted lenitive efficacy by reducing erythema, transepidermal water loss and blood flow of about 22%, 35% and 30% respectively. The study allowed us to point out the lenitive property of oleuropein, opening the way to further trials to deepen our specific knowledge about this natural molecule, which could be used in association with other active ingredients in cosmetics to repair UV damages.

  1. Efficacy of exercise and ultrasound in patients with lumbar spinal stenosis: a prospective randomized controlled trial.

    PubMed

    Goren, Ahmet; Yildiz, Necmettin; Topuz, Oya; Findikoglu, Gulin; Ardic, Fusun

    2010-07-01

    To assess the effectiveness of therapeutic exercises alone and in combination with a single physical agent - ultrasound - in patients with lumbar spinal stenosis. Randomized, prospective, controlled trial. Department of Physical Medicine and Rehabilitation, University Hospital. Forty-five patients presenting with symptoms of neurological claudication and magnetic resonance image-proven lumbar spinal stenosis were assigned to one of three groups: ultrasound plus exercise group (group 1, n =15), sham ultrasound plus exercise group (group 2, n= 15) and no exercise - no treatment group (control group, n = 15). Stretching and strengthening exercises for lumbar, abdominal, leg muscles as well as low-intensity cycling exercises were given as therapeutic exercises. Ultrasound was applied with 1 mHz, 1.5 W/cm(2) intensity, in continuous mode on the back muscle for 10 minutes in group 1 while ultrasound on/off mode was applied in group 2. Before and after a three-week period, all subjects were evaluated by pain, disability, functional capacity and consumption of analgesic. Thirty-two of the participants were women and 13 were men, with an average age of 53.2 +/- 12.68 years (range 25-82 years). After a three-week treatment period, leg pain decreased in group 1 (-1.47 +/- 3.02) and group 2 (-2.47 +/- 3.75) compared with the control group (P<0.05). Disability score decreased in group 1 (-3.94 +/- 7.20) and group 2 (-7.80 +/- 10.26) compared with control group (P<0.05). We did not find any statistically significant difference between groups 1 and 2 (P>0.05). The amount of analgesic consumption is significantly less in the group with ultrasound application compared to that in the control group (P<0.05). The results of our study suggest that therapeutic exercises are effective for pain and disability in patients with lumbar spinal stenosis and that addition of ultrasound to exercise therapy lowers the analgesic intake substantially.

  2. Efficacy of 1% acetic acid in the treatment of chronic wounds infected with Pseudomonas aeruginosa: prospective randomised controlled clinical trial.

    PubMed

    Madhusudhan, V L

    2016-12-01

    Chronic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic wounds. In the present study, an attempt has been made to use 1% acetic acid as the sole antimicrobial agent for the treatment of pseudomonal wound infections. A control limb was used in which the wounds were treated with normal saline. Our objective was to evaluate the efficacy of acetic acid in low concentration of 1% in chronic wounds infected with P. aeruginosa. This was a prospective study conducted over a period of 6 months. All patients with chronic wounds infected with P. aeruginosa. Wounds due to massive burns, suspected malignancy, immunocompromised individuals and individuals with sepsis. A total of 32 patients enrolled in the study. Subjects were randomised equally to the 1% acetic acid group and saline dressing group. None of the patients received any systemic antibiotics during the study period and received twice daily dressings. The endpoint of the treatment was wounds free of P. aeruginosa. The duration of treatment required to eliminate the Pseudomonas from the wounds in the acetic acid group was on an average 7 days less than that required by the saline group. P value was <0·001. In the 1% acetic acid group irrespective of the sensitivity of the organism to antibiotics, Pseudomonas organisms were eliminated within the same

  3. Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

    PubMed

    Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

    2016-02-01

    Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

  4. A prospective study of alcohol expectancies and self-efficacy as predictors of young adolescent alcohol misuse.

    PubMed

    Connor, J P; George, S M; Gullo, M J; Kelly, A B; Young, R McD

    2011-01-01

    To test the relative contribution of two key Social Learning Theory constructs, alcohol expectancies (AEs) and drinking refusal self-efficacy (DRSE), in predicting early adolescent drinking behavior and examine the possible mediational role of DRSE over AE. High school students (N = 192, mean age 14) were administered measures assessing AE (Drinking Expectancy Questionnaire--Adolescent version; DEQ-A), DRSE (Drinking Refusal Self-Efficacy Questionnaire--Revised Adolescent version; DRSEQ-RA) and indices of alcohol consumption and problem drinking. Age, gender, peer drinking, tobacco use and positive and negative behavioral characteristics were included in the statistical models as known predictors of alcohol misuse. Subjects were followed up at 12 months, with 88.5% retention. Initial confirmatory factor analyses verified factor structures of the DEQ-A and DRSEQ-RA. Prospective structural models controlling for Time 1 drinking behavior, age, gender, peer alcohol use, tobacco use and behavior problems identified that DRSE but not AE was associated with problem drinking 12-month post-initial assessment. DRSE mediated AE in predicting problem drinking. Results suggest that DRSE is a more salient cognitive construct than AE in early adolescence alcohol use. In this age group, prevention and treatment strategies that build refusal self-efficacy may be more effective than strategies that challenge AEs.

  5. A prospective randomized controlled trial on the efficacy of noninvasive ventilation in severe acute asthma.

    PubMed

    Gupta, Dheeraj; Nath, Alok; Agarwal, Ritesh; Behera, Digamber

    2010-05-01

    Noninvasive ventilation (NIV) is an emerging modality in the management of patients with acute respiratory failure. However, its role in severe acute asthma is not well defined. Evaluate the efficacy of NIV in severe acute asthma. Patients with severe acute asthma were randomized to receive either standard medical therapy or NIV in addition to medical therapy. The primary outcomes were improvement in forced expiratory volume in the first second (FEV1), intensive care unit (ICU) stay, and hospital stay. The secondary outcomes were rate of improvement in respiratory rate, blood pH, ratio of PaO2 to fraction of inspired oxygen (F(I)O2), PaCO2, requirement for inhaled medications, and failure of primary therapy. Fifty-three patients with severe acute asthma (42 females and 11 males, mean +/- SD age 44 +/- 15 y, FEV1 < 30% of predicted) were randomized to NIV (n = 28) or standard medical therapy (n = 25). The baseline variables were similar in the 2 groups except for the mean duration of asthma, which was shorter in the standard-medical-therapy group. The median inspiratory and expiratory airway pressures applied were 12 cm H2O and 5 cm H2O, respectively. There was a significant improvement in respiratory rate, FEV1, and PaO2/F(I)O2 (but not pH or PaCO2) in both the groups, but no significant difference between the 2 groups. The number of patients who had a > or = 50% improvement in FEV1 at 1, 2, and 4 hours was nonsignificantly greater in the NIV arm. ICU and hospital stay was significantly shorter in the NIV group. The mean dose of inhaled bronchodilator was significantly less in the NIV group. There were 4 instances of standard-medical-therapy failure, and all those patients improved with NIV. Two patients in the NIV arm required invasive ventilation. There was no mortality in either of the arms. In patients with severe acute asthma, the addition of NIV to standard medical therapy probably accelerates the improvement in lung function, decreases the inhaled

  6. Evaluation of the Program Effectiveness of Research Competence Development in Prospective Elementary School Teachers

    ERIC Educational Resources Information Center

    Khan, Natalya N.; Kolumbayeva, Sholpan Zh.; Karsybayeva, Raissa K.; Nabuova, Roza A.; Kurmanbekova, Manshuk B.; Syzdykbayeva, Aigul Dzh.

    2016-01-01

    To develop research competence in prospective teachers, a system of methods for diagnostics and formation of this competence in prospective elementary school teachers in the training process is designed. To diagnose the research competence, a series of techniques were used that allow subtle evaluation of each competence research component:…

  7. An Evaluation of the Self-Efficacy Theory in Agricultural Education

    ERIC Educational Resources Information Center

    McKim, Aaron J.; Velez, Jonathan J.

    2016-01-01

    This research sought to evaluate the use of the self-efficacy theory in agricultural education. A total of 30 studies, published between 1997 and 2013 using self-efficacy as a theoretical foundation were compiled and analyzed. The findings of these studies were compared to expected outcomes identified by the self-efficacy theory, specifically the…

  8. Increasing Career Self-Efficacy for Women: Evaluating a Group Intervention.

    ERIC Educational Resources Information Center

    Sullivan, Kate Roy; Mahalik, James R.

    2000-01-01

    Evaluates whether women participating in a career group designed to increase career-related self-efficacy would make gains on career decision-making self-efficacy and vocational exploration and commitment compared with women in a control group. Results indicate that women in the treatment group improved on career decision-making self-efficacy and…

  9. An Evaluation of the Self-Efficacy Theory in Agricultural Education

    ERIC Educational Resources Information Center

    McKim, Aaron J.; Velez, Jonathan J.

    2016-01-01

    This research sought to evaluate the use of the self-efficacy theory in agricultural education. A total of 30 studies, published between 1997 and 2013 using self-efficacy as a theoretical foundation were compiled and analyzed. The findings of these studies were compared to expected outcomes identified by the self-efficacy theory, specifically the…

  10. Ezogabine: an evaluation of its efficacy and safety as adjunctive therapy for partial-onset seizures in adults.

    PubMed

    Yamada, Mikiko; Welty, Timothy E

    2012-10-01

    To evaluate the safety, efficacy, pharmacokinetics, pharmacodynamic properties, and clinical application of ezogabine (retigabine, INN), an antiepileptic drug approved in 2011. Published data from in vitro, animal, and clinical studies were obtained from PubMed and CINAHL searches, from January 1980 to March 31, 2012. Other relevant data regarding the safety and efficacy of ezogabine were obtained from the Food and Drug Administration and the European Medication Agency Web sites. Selected articles were prospective in vitro, animal, and controlled clinical studies of ezogabine. Non-English-language articles were excluded. In vitro and animal studies show that ezogabine activates voltagegated potassium channels, leading to reduction of seizure frequency by inhibiting hyperexcitability activity in the central nervous system. Additionally, ezogabine enhances γ-aminobutyric acid (GABA) activity and de novo GABA synthesis. Eight clinical studies of ezogabine have been published, 5 being Phase 1 clinical trials in healthy subjects and 3 being Phase 3 clinical trials in patients with pharmaco-resistant partial-onset seizures. Phase 3 clinical trials demonstrated the safety and efficacy of ezogabine in patients with partial-onset seizures. Clinical trials have shown that ezogabine is efficacious as an adjunctive agent in patients with pharmacoresistant partial seizures. Careful monitoring of drug interactions and adverse reactions is necessary. While ezogabine is efficacious for partial seizures, its precise role in the management of patients with epilepsy is yet to be determined.

  11. Niger Delta basin oil and gas prospects evaluated

    SciTech Connect

    Not Available

    1992-09-28

    This paper reports that an ambitious project to map African oil and gas prospects has produced its first findings in a report on the Niger Delta basin. In Nigeria, 73% of discoveries are smaller than 50 million bbl, with a 42% success rate for wildcats. There are 'out of round prospects off Nigeria, too, with a number of companies currently in discussions. Petroconsultants the there are further opportunities for exploration in the Northern Onshore Fringe Belt, which has an estimated potential of 500 million bbl of reserves. Three OPLs are open.

  12. Need of UV protection and evaluation of efficacy of sunscreens.

    PubMed

    Kaur, Anoopinder; Thatai, Purva; Sapra, Bharti

    2014-01-01

    Sun exposure has been coupled with numerous types of acute and chronic reactions in skin, for example, sun burns, photoimmune suppression, photoaging, and skin cancer. In scrutiny of growing understanding of the potentially unfavorable long-term side effects of solar irradiation, there is a universal call for harmless and effective photoprotectants. Photoprotective agents are used for protection against ultraviolet (UV) radiations. In support of best photoprotective measures, now sunscreens are in great demand. Safeguard from UVB is quantified as a minimal erythema dose-based sun protection factor (SPF). UVA protection testing methods include evaluation of persistent pigment darkening (PPD) and critical wavelength. The rationale of this review is to present the contemporary information on the cutaneous pathophysiology of photooxidative stress, to study different UV filters with their UV spectrum and various commercially available sunscreens, with special emphasis on their active ingredients and SPFs. The characterization of different parameters to evaluate the efficacy of sunscreens, for example, SPF, immune suppression factor, photostability, and water resistance, have been described on the basis of findings from different researchers.

  13. Pharmacoeconomic evaluation of new treatments: efficacy versus effectiveness studies?

    PubMed Central

    Bombardier, C; Maetzel, A

    1999-01-01

    The juxtaposition of economic and clinical evaluation raises new issues in the design of clinical trials. Recent pharmacoeconomic guidelines provide some direction, but do not deal with the appropriate timing of economic evaluations in the drug developmental process. Ideally, pharmacoeconomic data should be available at the time of the regulatory and formulary decision making. Current pivotal phase III trials do not provide these data; they are designed to test safety and efficacy (does the drug work under optimal circumstances?) and not to answer questions about the effectiveness of a drug, the more relevant question for economic analysis (does the drug work in usual care?). The use of more "naturalistic" designs for some phase III randomised trials has been suggested. These so called "effectiveness trials" more closely reflect routine clinical practice. They use a more flexible dosage regimen, and a "usual care" instead of a placebo comparator. Patients randomised are more representative of actual practice and outcomes include quality of life and utility measures. They are more suited to provide the data needed to estimate the real benefit of the treatment in actual care. When costs are applied and compared with these benefits, you can estimate the efficiency of allocating resources to this new drug. Increasing the use of effectiveness trials in phase III would decrease the need for economic modelling.

 PMID:10577979

  14. The Efficacy of Stuttering Measurement Training: Evaluating Two Training Programs

    PubMed Central

    Bainbridge, Lauren A.; Stavros, Candace; Ebrahimian, Mineh; Wang, Yuedong

    2015-01-01

    Purpose Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Method Four groups, each with 12 randomly allocated participants, completed a pretest–posttest design training study. They were evaluated by their counts of stuttering events on eight 3-min audiovisual speech samples from adults and children who stutter. Stuttering judgment training involved use of either the Stuttering Measurement System (SMS), Stuttering Measurement Assessment and Training (SMAAT) programs, or no training. To test for the reliability of any training effect, SMS training was repeated with the 4th group. Results Both SMS-trained groups produced approximately 34% improvement, significantly better than no training or the SMAAT program. The SMAAT program produced a mixed result. Conclusions The SMS program was shown to produce a “medium” effect size improvement in the accuracy of stuttering event counts, and this improvement was almost perfectly replicated in a 2nd group. Half of the SMAAT judges produced a 36% improvement in accuracy, but the other half showed no improvement. Additional studies are needed to demonstrate the durability of the reported improvements, but these positive effects justify the importance of stuttering measurement training. PMID:25629956

  15. The efficacy of stuttering measurement training: evaluating two training programs.

    PubMed

    Bainbridge, Lauren A; Stavros, Candace; Ebrahimian, Mineh; Wang, Yuedong; Ingham, Roger J

    2015-04-01

    Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Four groups, each with 12 randomly allocated participants, completed a pretest-posttest design training study. They were evaluated by their counts of stuttering events on eight 3-min audiovisual speech samples from adults and children who stutter. Stuttering judgment training involved use of either the Stuttering Measurement System (SMS), Stuttering Measurement Assessment and Training (SMAAT) programs, or no training. To test for the reliability of any training effect, SMS training was repeated with the 4th group. Both SMS-trained groups produced approximately 34% improvement, significantly better than no training or the SMAAT program. The SMAAT program produced a mixed result. The SMS program was shown to produce a "medium" effect size improvement in the accuracy of stuttering event counts, and this improvement was almost perfectly replicated in a 2nd group. Half of the SMAAT judges produced a 36% improvement in accuracy, but the other half showed no improvement. Additional studies are needed to demonstrate the durability of the reported improvements, but these positive effects justify the importance of stuttering measurement training.

  16. I-COMBINE study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with amlodipine monotherapy in hypertensive patients uncontrolled with amlodipine 5 mg monotherapy: a multicenter, phase III, prospective, randomized, open-label with blinded-end point evaluation study.

    PubMed

    Bobrie, Guillaume

    2012-08-01

    Hypertension guidelines recommend the use of 2 agents with synergistic action when >1 agent is needed to achieve blood pressure goals. Newer antihypertensive treatment combinations include fixed-dose combinations of an angiotensin receptor blocker and a calcium channel blocker. The I-COMBINE study aimed to determine whether the antihypertensive efficacy of the fixed-dose combination irbesartan 150 mg/amlodipine 5 mg (I150/A5) was superior to that of amlodipine 5 mg (A5) monotherapy in lowering home systolic blood pressure (HSBP) after 5 weeks' treatment. The I-COMBINE study was a 10-week, multicenter, Phase III, prospective, randomized, parallel-group, open-label with blinded-endpoint study. The main inclusion criterion was essential uncontrolled hypertension (SBP ≥145 mm Hg at office, after at least 4 weeks of A5 monotherapy administered once daily). Patients continued to receive A5 for 7 to 10 days and were randomized to either monotherapy with A5 for 5 weeks then amlodipine 10 mg (A10) for the next 5 weeks or to a fixed-dose combination therapy (I150/A5 then I150/A10). Safety profile was assessed by recording adverse events reported by patients or observed by the investigator. Following enrollment, 290 patients were randomized to treatment, and 287 (mean [SD] age, 57.3 [11.2] years; 48% male) were included in the intention-to-treat analysis: 144 patients treated with I150/A5 then I150/A10, and 143 patients treated with A5 then A10. At randomization, mean HSBP was similar in both groups: 148.5 (10.3) mm Hg in the I150/A5 group and 149.2 (9.7) mm Hg in the A5 group. At week 5, the adjusted mean difference in HSBP between groups was -6.2 (1.0) mm Hg (P < 0.001). The proportion of controlled patients (mean home blood pressure <135 and 85 mm Hg) was significantly higher in the I150/A5 group than in the A5 group (P < 0.001). Treatment-emergent adverse events were experienced by 13.8% of I150/A5-treated patients and 11.9% of A5-treated patients during the first 5

  17. Prospect evaluation of shallow I-35 reservoir of NE Malay Basin offshore, Terengganu, Malaysia

    SciTech Connect

    Janjua, Osama Akhtar Wahid, Ali Salim, Ahmed Mohamed Ahmed; Rahman, M. Nasir B. A.

    2016-02-01

    A potential accumulation of hydrocarbon that describes significant and conceivable drilling target is related to prospect. Possibility of success estimation, assuming discovery of hydrocarbons and the potential recoverable quantities range under a commercial development program are the basis of Prospect evaluation activities. The objective was to find the new shallow prospects in reservoir sandstone of I –Formation in Malay basin. The prospects in the study area are mostly consisting of faulted structures and stratigraphic channels. The methodology follows seismic interpretation and mapping, attribute analysis, evaluation of nearby well data i.e., based on well – log correlation. The petrophysical parameters analogue to nearby wells was used as an input parameter for volumetric assessment. Based on analysis of presence and effectiveness, the prospect has a complete petroleum system. Two wells have been proposed to be drilled near the major fault and stratigraphic channel in I-35 reservoir that is O-1 and O-2 prospects respectively. The probability of geological success of prospect O-1 is at 35% while for O-2 is 24%. Finally, for hydrocarbon in place volumes were calculated which concluded the best estimate volume for oil in O-1 prospect is 4.99 MMSTB and O-2 prospect is 28.70 MMSTB while for gas is 29.27 BSCF and 25.59 BSCF respectively.

  18. Prospect evaluation of shallow I-35 reservoir of NE Malay Basin offshore, Terengganu, Malaysia

    NASA Astrophysics Data System (ADS)

    Janjua, Osama Akhtar; Wahid, Ali; Salim, Ahmed Mohamed Ahmed; Rahman, M. Nasir B. A.

    2016-02-01

    A potential accumulation of hydrocarbon that describes significant and conceivable drilling target is related to prospect. Possibility of success estimation, assuming discovery of hydrocarbons and the potential recoverable quantities range under a commercial development program are the basis of Prospect evaluation activities. The objective was to find the new shallow prospects in reservoir sandstone of I -Formation in Malay basin. The prospects in the study area are mostly consisting of faulted structures and stratigraphic channels. The methodology follows seismic interpretation and mapping, attribute analysis, evaluation of nearby well data i.e., based on well - log correlation. The petrophysical parameters analogue to nearby wells was used as an input parameter for volumetric assessment. Based on analysis of presence and effectiveness, the prospect has a complete petroleum system. Two wells have been proposed to be drilled near the major fault and stratigraphic channel in I-35 reservoir that is O-1 and O-2 prospects respectively. The probability of geological success of prospect O-1 is at 35% while for O-2 is 24%. Finally, for hydrocarbon in place volumes were calculated which concluded the best estimate volume for oil in O-1 prospect is 4.99 MMSTB and O-2 prospect is 28.70 MMSTB while for gas is 29.27 BSCF and 25.59 BSCF respectively.

  19. Twelve-Month Efficacy and Safety Data for the "Stress Incontinence Control, Efficacy and Safety Study": A Phase III, Multicenter, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence Using the Vesair Intravesical Balloon.

    PubMed

    Winkler, Harvey; Jacoby, Karny; Kalota, Susan; Snyder, Jeffrey; Cline, Kevin; Robertson, Kaiser; Kahan, Randall; Green, Lonny; McCammon, Kurt; Rovner, Eric; Rardin, Charles

    2017-09-26

    The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months. The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months. A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%). In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events

  20. Computer Technology Training for Prospective Teachers: Computer Attitudes and Perceived Self-Efficacy.

    ERIC Educational Resources Information Center

    Milbrath, Ying-Chen L.; Kinzie, Mable B.

    2000-01-01

    This longitudinal study conducted at the University of Virginia examined preservice teachers' changes in computer anxiety; perceived usefulness of computer technology; frequency of using word processing, email, spreadsheets, database management, statistical packages, and CD-ROM databases; and perceived self-efficacy. Discusses time effect and…

  1. Evaluating Prospects: The Criteria Used to Hire New Teachers

    ERIC Educational Resources Information Center

    Cranston, Jerome

    2012-01-01

    Teacher hiring decisions have far-reaching effects. Accordingly, it is important that prospective teachers be scrutinized carefully. The process that yields new teacher hires also deserves careful analysis. This article reports on key findings derived from a larger study that examined the overall organization of the hiring process and how criteria…

  2. Evaluating the Effectiveness of College Web Sites for Prospective Students

    ERIC Educational Resources Information Center

    Ford, Wendy G.

    2011-01-01

    College Web sites are often the first structured encounter a student has with a prospective college or university. Outside of serving as a marketing tool (Williams 2000), very little literature exists on the functional purpose of a college's Web site. Almost all college sites show an informational and transactional tool for currently enrolled…

  3. Comparison of clinical and physiological efficacies of different intermittent sequential pneumatic compression devices in preventing deep vein thrombosis: a prospective randomized study.

    PubMed

    Koo, Ki Hyoung; Choi, Jae-Sung; Ahn, Ji Hyun; Kwon, Jae Hyun; Cho, Keun-Tae

    2014-12-01

    There are few comparative studies about the optimal method of pneumatic compression to prevent deep vein thrombosis (DVT). The aim of this prospective randomized study was to compare venous hemodynamic changes and their clinical influences between two graded sequential compression groups (an alternate sequential compression device [ASCD] vs. a simultaneous sequential compression device [SSCD]). In total, 34 patients (68 limbs) undergoing knee and spine operations were prospectively randomized into two device groups (ASCD vs. SSCD groups). Duplex ultrasonography examinations were performed on the 4th and 7th postoperative days for the detection of DVT and the evaluation of venous hemodynamics. Continuous data for the two groups were analyzed using a two-tailed, unpaired t-test. Relative frequencies of unpaired samples were compared using Fisher exact test. Mixed effects models that might be viewed as ANCOVA models were also considered. DVT developed in 7 patients (20.6%), all of whom were asymptomatic for isolated calf DVTs. Two of these patients were from the ASCD group (11.8%) and the other five were from the SSCD group (29.4%), but there was no significant difference (p = 0.331). Baseline peak velocity, mean velocity, peak volume flow, and total volume flow were enhanced significantly in both device groups (p < 0.001). However, the degrees of flow and velocity enhancement did not differ significantly between the groups. The accumulated expelled volumes for an hour were in favor of the ASCD group. Both graded sequential compression devices showed similar results both in clinical and physiological efficacies. Further studies are required to investigate the optimal intermittent pneumatic compression method for enhanced hemodynamic efficacy and better thromboprophylaxis.

  4. Comparison of Clinical and Physiological Efficacies of Different Intermittent Sequential Pneumatic Compression Devices in Preventing Deep Vein Thrombosis: A Prospective Randomized Study

    PubMed Central

    Koo, Ki Hyoung; Ahn, Ji Hyun; Kwon, Jae Hyun; Cho, Keun-Tae

    2014-01-01

    Background There are few comparative studies about the optimal method of pneumatic compression to prevent deep vein thrombosis (DVT). The aim of this prospective randomized study was to compare venous hemodynamic changes and their clinical influences between two graded sequential compression groups (an alternate sequential compression device [ASCD] vs. a simultaneous sequential compression device [SSCD]). Methods In total, 34 patients (68 limbs) undergoing knee and spine operations were prospectively randomized into two device groups (ASCD vs. SSCD groups). Duplex ultrasonography examinations were performed on the 4th and 7th postoperative days for the detection of DVT and the evaluation of venous hemodynamics. Continuous data for the two groups were analyzed using a two-tailed, unpaired t-test. Relative frequencies of unpaired samples were compared using Fisher exact test. Mixed effects models that might be viewed as ANCOVA models were also considered. Results DVT developed in 7 patients (20.6%), all of whom were asymptomatic for isolated calf DVTs. Two of these patients were from the ASCD group (11.8%) and the other five were from the SSCD group (29.4%), but there was no significant difference (p = 0.331). Baseline peak velocity, mean velocity, peak volume flow, and total volume flow were enhanced significantly in both device groups (p < 0.001). However, the degrees of flow and velocity enhancement did not differ significantly between the groups. The accumulated expelled volumes for an hour were in favor of the ASCD group. Conclusions Both graded sequential compression devices showed similar results both in clinical and physiological efficacies. Further studies are required to investigate the optimal intermittent pneumatic compression method for enhanced hemodynamic efficacy and better thromboprophylaxis. PMID:25436073

  5. A prospective study of return to work across health conditions: perceived work attitude, self-efficacy and perceived social support.

    PubMed

    Brouwer, Sandra; Reneman, Michiel F; Bültmann, Ute; van der Klink, Jac J L; Groothoff, Johan W

    2010-03-01

    The aim of the present study was to conduct subgroup-analyses in a prospective cohort of workers on long-term sickness absence to investigate whether associations between perceived work attitude, self-efficacy and perceived social support and time to RTW differ across different health conditions. The study was based on a sample of 926 workers on sickness absence (6-12 weeks). The participants filled out a baseline questionnaire and were subsequently followed until the tenth month after listing sick. Perceived work attitude was measured with a Dutch language version of the Work Involvement Scale. Perceived social support was measured with a self-constructed standardized scale reflecting a person's perception of social support regarding RTW. Self-efficacy was measured with the standardised Dutch version of the General self-efficacy scale, assessing the subjects' expectations of their general capacities. The sample was divided into three subgroups: musculoskeletal health conditions, other physical health conditions and mental health conditions. Anova analyses and Cox proportional hazards regression analyses were used to identify differences in association between the three factors and the time to RTW between different subgroups. The associations between the perceived work attitude, self-efficacy and perceived social support and the time to RTW vary across different health condition subgroups, not only with regard to the strength of the association but also for the type of factor. In the multivariate model, hazard ratios (HRs) of 1.33 (95% CI 1.01-1.75) in the musculoskeletal subgroup, and 1.26 (95% CI 0.89-1.78) in the other physical subgroup were found in perceived work attitude. With regard to perceived social support HRs of 1.39 (95% CI 1.12-1.99) respectively 1.51 (1.05-2.17) in the same subgroups were found. Only self-efficacy remained in the multivariate model in all subgroups with HRs of 1.49 (95% CI 1.12-1.99) in the musculoskeletal subgroup, 1.53 (95% CI 1

  6. Efficacy and tolerability of six-week extended dosing interval with tocilizumab therapy in a prospective cohort as remission maintenance in patients with rheumatoid arthritis.

    PubMed

    Kikuchi, Jun; Kondo, Tsuneo; Shibata, Akiko; Sakai, Ryota; Okada, Yusuke; Chino, Kentaro; Okuyama, Ayumi; Kurasawa, Takahiko; Takei, Hirofumi; Amano, Koichi

    2017-08-29

    To prospectively evaluate the efficacy and tolerability of a six-week extended dosing interval with tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in sustained remission. Patients who received over six doses of intravenous TCZ in clinical remission (disease activity score [DAS] 28 - erythrocyte sedimentation rate [ESR] ≤ 2.6) maintained over 3 months between December 2013 and December 2015 were included. Flare was defined as DAS28-ESR >3.2 at two consecutive visits. Twenty-five patients were enrolled; 87.5% achieved clinical remission at week 54 after six-week extension and 95.5% achieved a van der Heijde modified total Sharp score (ΔmTSS) ≤0.5. The Health Assessment Questionnaire Disability Index (HAQ-DI) did not increase during 54 weeks. HAQ-DI at baseline and ΔDAS28-ESR at week six positively correlated with increase in DAS28-ESR at week 54. ΔSwollen joint count at week six positively correlated with ΔmTSS at week 54. A total of 12 adverse events occurring in 10 patients did not lead to cessation of TCZ except for one case of recurrent lymphoproliferative disorder at week five. A six-week extended dosing interval of TCZ for patients with RA in sustained remission is proposed as an acceptable treatment option for maintaining efficacy and tolerability.

  7. Quantized Step-up Model for Evaluation of Internship in Teaching of Prospective Science Teachers.

    ERIC Educational Resources Information Center

    Sindhu, R. S.

    2002-01-01

    Describes the quantized step-up model developed for the evaluation purposes of internship in teaching which is an analogous model of the atomic structure. Assesses prospective teachers' abilities in lesson delivery. (YDS)

  8. Quantized Step-up Model for Evaluation of Internship in Teaching of Prospective Science Teachers.

    ERIC Educational Resources Information Center

    Sindhu, R. S.

    2002-01-01

    Describes the quantized step-up model developed for the evaluation purposes of internship in teaching which is an analogous model of the atomic structure. Assesses prospective teachers' abilities in lesson delivery. (YDS)

  9. Evaluation of physiotherapy in a prospective cohort of early axial spondyloarthritis. Data from the DESIR cohort.

    PubMed

    Escalas, Cécile; Dalichampt, Marie; Dougados, Maxime; Poiraudeau, Serge

    2016-03-01

    To evaluate the effect of physiotherapy on functional limitation in an observational cohort of early axial spondyloarthritis. prospective population-based cohort study. 708 patients with early axial spondyloarthritis between 2007 and 2010 naive of TNF blockers. early physiotherapy defined by at least eight supervised sessions of physical therapy during the first six months. the primary outcome was functional improvement defined by a relative improvement of at least 20% in BASFI at six months. Secondary outcomes were improvement in BASFI at one and two years and ASAS20 response criteria at six months. a propensity score of having physiotherapy was developed and multivariate analysis using propensity score weighting were used to assess the effect of physiotherapy on outcome. Overall, 166 (24%) patients had physiotherapy during the first six months. After using propensity score weighting, there was no functional improvement on the primary outcome in patients treated with early physical therapy (relative risk [IC95%]: 1.15 [0.91-1.45]). No differences were observed on secondary outcomes (relative risk [IC95%]: 0.94 [0.80-1.11]). It seems there is no functional benefit for patients with early spondyloarthritis to be treated early by physiotherapy in daily practice, even though the efficacy of physiotherapy has been shown in several randomized controlled studies. Copyright © 2015 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

  10. A Prospective Evaluation of Transverse Tracheal Sonography During Emergent Intubation by Emergency Medicine Resident Physicians.

    PubMed

    Lahham, Shadi; Baydoun, Jamie; Bailey, James; Sandoval, Sandra; Wilson, Sean P; Fox, John C; Slattery, David E

    2017-10-01

    Establishing a definitive airway is often the first step in emergency department treatment of critically ill patients. Currently, there is no agreed upon consensus as to the most efficacious method of airway confirmation. Our objective was to determine the diagnostic accuracy of real-time sonography performed by resident physicians to confirm placement of the endotracheal tube during emergent intubation. We performed a prospective cohort study of adult patients in the emergency department undergoing emergent endotracheal intubation. Thirty emergency medicine residents, who were blinded to end-tidal carbon dioxide detection results, performed real-time transverse tracheal sonography during intubation to evaluate correct endotracheal tube placement. Seventy-two patients were enrolled in the study. Sixty-eight instances (94.4%) were interpreted as correct placement in the trachea; 4 (5.6%) were interpreted as esophageal, of which 1 was a false-negative finding, therefore conferring sensitivity of 98.5% (95% confidence interval, 92.1%-99.9%) and specificity of 75.0% (95% confidence interval, 19.4%-99.4%) for correct placement. There was no significant difference in accuracy among resident sonographers with different levels of residency training. A simple transverse tracheal sonographic examination performed by emergency medicine resident physicians can be used as an adjunct to help confirm correct endotracheal tube placement during intubation. In our cohort, the level of training did not appear to affect the ability of residents to correctly identify the endotracheal tube position. © 2017 by the American Institute of Ultrasound in Medicine.

  11. A prospective evaluation of zirconia anterior partial fixed dental prostheses: Clinical results after seven years.

    PubMed

    Solá-Ruíz, Maria Fernanda; Agustin-Panadero, Rubén; Fons-Font, Antonio; Labaig-Rueda, Carlos

    2015-06-01

    Because of the high mechanical strength of zirconium dioxide, the metal in fixed partial prostheses can now be replaced. However, the material is susceptible to aging or hydrothermal degradation and to chipping of the feldspathic veneer. The purpose of this prospective study was to evaluate the survival (without failure) and success (survival without any complication or failure) rate and clinical efficacy of anterior zirconia partial fixed dental prostheses. Twenty-seven anterior partial fixed dental prostheses of 3 to 6 units were fabricated. All participants were examined after 1 month and 6 months, then annually for 7 years. Three partial fixed dental prostheses failed and had to be removed: 2 because of secondary caries, which increased failure significantly (P=.001) and 1 because of severe chipping. Six partial fixed dental prostheses had complications: 2 debonded, 3 had chipping, and 1 had periapical pathology. All veneer porcelain fractures occurred in 6-unit fixed partial prostheses (P=.002). The clinical success rate was 88.8% after the 7-year follow-up. The clinical behavior of partial fixed dental prostheses with a zirconium dioxide core in the anterior region provides an adequate medium-term survival rate. The main cause of failure was secondary caries. The most frequent complication was chipping, which was directly related to the number of units of the prosthesis. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  12. International prospective evaluation of scintimammography with (99m)technetium sestamibi.

    PubMed

    Sampalis, Fotini S; Denis, Ronald; Picard, Daniel; Fleiszer, David; Martin, Ginette; Nassif, Edgard; Sampalis, John S

    2003-06-01

    The purpose of this study is to evaluate the efficacy of scintimammography with (99m)Technetium-Sestamibi for the diagnosis of breast cancer. This was a multicenter prospective cohort clinical trial. A total of 1,734 women were enrolled of whom 1,243 had complete data upon study completion. The mean +/- standard error age of the patients is 56 +/-12 years (with a range of 19 to 94). Mammographic results were classified by the Breast Imaging Reporting and Data System (BIRADS) as 199 (16%) BIRADS 5, 149 (12%) BIRADS 4, 199 (16%) BIRADS 3, and 696 (56%) BIRADS 2 or 1. Scintimammography was positive for 322 (26%) of the patients and negative for 921 (76%). Histopathology showed malignancy for 201 (16%) of the patients. Sensitivity and specificity of scintimammography was estimated 93% and 87% respectively. A positive predictive value (PPV) of 58% with a negative predictive value of 98% were calculated. The present study suggests that scintimammography with (99m)Technetium-Sestamibi is highly accurate for the detection of breast cancer.

  13. Self-efficacy and progression of periodontal disease: a prospective cohort study.

    PubMed

    Mizutani, Shinsuke; Ekuni, Daisuke; Tomofuji, Takaaki; Irie, Koichiro; Azuma, Tetsuji; Iwasaki, Yoshiaki; Morita, Manabu

    2015-12-01

    The purpose of this longitudinal study was to investigate whether self-efficacy scale for self-care (SESS) was related to changes in oral health behaviours and progression of periodontal disease in Japanese university students. Students (n = 533) who were interested in receiving oral health examinations before entering the university and before graduation were included in the analysis. Self-efficacy was assessed using SESS, which uses three subscales: self-efficacy for brushing of the teeth (SE-BR), for dentist consultations (SE-DC) and for dietary habits. The informations about oral health behaviours were also collected. For all participants, oral hygiene instructions was performed at baseline. After 3 years, the oral health behaviours and the periodontal condition were re-assessed. The progression of periodontal disease was related to low baseline SE-BR. Logistic regression analysis showed that progression of periodontal disease risk during a 3-year period was associated with low baseline SE-BR (OR: 1.516; 95% CI: 1.010-2.275; p < 0.05). The increase in the score of SE-DC was related to the increase in regular dental checkups (p < 0.05). Low SESS was associated with progression of periodontal disease and improvement of oral health behaviours in university students who received oral hygiene instructions at baseline. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Evaluating the Potential Efficacy of Invasive Lionfish (Pterois volitans) Removals

    PubMed Central

    Barbour, Andrew B.; Allen, Michael S.; Frazer, Thomas K.; Sherman, Krista D.

    2011-01-01

    The lionfish, Pterois volitans (Linnaeus) and Pterois miles (Bennett), invasion of the Western Atlantic Ocean, Caribbean Sea and Gulf of Mexico has the potential to alter aquatic communities and represents a legitimate ecological concern. Several local removal programs have been initiated to control this invasion, but it is not known whether removal efforts can substantially reduce lionfish numbers to ameliorate these concerns. We used an age-structured population model to evaluate the potential efficacy of lionfish removal programs and identified critical data gaps for future studies. We used high and low estimates for uncertain parameters including: length at 50% vulnerability to harvest (Lvul), instantaneous natural mortality (M), and the Goodyear compensation ratio (CR). The model predicted an annual exploitation rate between 35 and 65% would be required to cause recruitment overfishing on lionfish populations for our baseline parameter estimates for M and CR (0.5 and 15). Lionfish quickly recovered from high removal rates, reaching 90% of unfished biomass six years after a 50-year simulated removal program. Quantifying lionfish natural mortality and the size-selective vulnerability to harvest are the most important knowledge gaps for future research. We suggest complete eradication of lionfish through fishing is unlikely, and substantial reduction of adult abundance will require a long-term commitment and may be feasible only in small, localized areas where annual exploitation can be intense over multiple consecutive years. PMID:21572951

  15. Efficacy and Safety Evaluation of a Chlorine Dioxide Solution.

    PubMed

    Ma, Jui-Wen; Huang, Bin-Syuan; Hsu, Chu-Wei; Peng, Chun-Wei; Cheng, Ming-Long; Kao, Jung-Yie; Way, Tzong-Der; Yin, Hao-Chang; Wang, Shan-Shue

    2017-03-22

    In this study, a chlorine dioxide solution (UC-1) composed of chlorine dioxide was produced using an electrolytic method and subsequently purified using a membrane. UC-1 was determined to contain 2000 ppm of gaseous chlorine dioxide in water. The efficacy and safety of UC-1 were evaluated. The antimicrobial activity was more than 98.2% reduction when UC-1 concentrations were 5 and 20 ppm for bacteria and fungi, respectively. The half maximal inhibitory concentrations (IC50) of H1N1, influenza virus B/TW/71718/04, and EV71 were 84.65 ± 0.64, 95.91 ± 11.61, and 46.39 ± 1.97 ppm, respectively. A 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) test revealed that the cell viability of mouse lung fibroblast L929 cells was 93.7% at a 200 ppm UC-1 concentration that is over that anticipated in routine use. Moreover, 50 ppm UC-1 showed no significant symptoms in a rabbit ocular irritation test. In an inhalation toxicity test, treatment with 20 ppm UC-1 for 24 h showed no abnormality and no mortality in clinical symptoms and normal functioning of the lung and other organs. A ClO₂ concentration of up to 40 ppm in drinking water did not show any toxicity in a subchronic oral toxicity test. Herein, UC-1 showed favorable disinfection activity and a higher safety profile tendency than in previous reports.

  16. Clinical Evaluation of Efficacy of CIA and CNA Intrusion Arches.

    PubMed

    Sharma, Swati; Vora, Sambhav; Pandey, Vinisha

    2015-09-01

    Excessive overbite is one of the most common problems that confront the orthodontist. Deep bite can be due to infraocclusion of posterior teeth, supraocclusion of anterior teeth or a combination of the two. Correction of same can be carried out by extrusion of molars, intrusion of incisors or by a combination of both respectively. Various intrusion arches are recommended for correcting deep bite by true intrusion of anterior teeth, Utility arches, Segmental arch, Connecticut Intrusion Arch (CIA) and Connecticut New Arch (CNA). The purpose of this study was to evaluate clinical efficacy of CIA and CNA intrusion arches. Tracings recorded from pre and post-treatment lateral cephalograms of 25 patients treated by CIA (Group I) and another 25 patients treated by CNA (Group II) intrusion arches in deep bite cases after four months of treatment were analysed and findings were recorded. Paired t-test was used to compare pre and post-treatment changes within Groups I and II and unpaired t-test was used to compare treatment changes between Group I and Group II. A P-value of < 0.05 was set for statistical significance. Findings of this study demonstrate that an average of 1mm of intrusion takes place with CIA intrusion arch and 1.3mm with CNA intrusion arch in a period of 4 months. Both intrusion arches do not affect the position of molar in vertical or anteroposterior plane. Both CIA and CNA intrusion arches are effective in bringing about intrusion of lower incisors.

  17. Evaluating the potential efficacy of invasive lionfish (Pterois volitans) removals.

    PubMed

    Barbour, Andrew B; Allen, Micheal S; Allen, Michael S; Frazer, Thomas K; Sherman, Krista D

    2011-05-10

    The lionfish, Pterois volitans (Linnaeus) and Pterois miles (Bennett), invasion of the Western Atlantic Ocean, Caribbean Sea and Gulf of Mexico has the potential to alter aquatic communities and represents a legitimate ecological concern. Several local removal programs have been initiated to control this invasion, but it is not known whether removal efforts can substantially reduce lionfish numbers to ameliorate these concerns. We used an age-structured population model to evaluate the potential efficacy of lionfish removal programs and identified critical data gaps for future studies. We used high and low estimates for uncertain parameters including: length at 50% vulnerability to harvest (L(vul)), instantaneous natural mortality (M), and the Goodyear compensation ratio (CR). The model predicted an annual exploitation rate between 35 and 65% would be required to cause recruitment overfishing on lionfish populations for our baseline parameter estimates for M and CR (0.5 and 15). Lionfish quickly recovered from high removal rates, reaching 90% of unfished biomass six years after a 50-year simulated removal program. Quantifying lionfish natural mortality and the size-selective vulnerability to harvest are the most important knowledge gaps for future research. We suggest complete eradication of lionfish through fishing is unlikely, and substantial reduction of adult abundance will require a long-term commitment and may be feasible only in small, localized areas where annual exploitation can be intense over multiple consecutive years.

  18. Reinforcement Magnitude: An Evaluation of Preference and Reinforcer Efficacy

    ERIC Educational Resources Information Center

    Trosclair-Lasserre, Nicole M.; Lerman, Dorothea C.; Call, Nathan A.; Addison, Laura R.; Kodak, Tiffany

    2008-01-01

    Consideration of reinforcer magnitude may be important for maximizing the efficacy of treatment for problem behavior. Nonetheless, relatively little is known about children's preferences for different magnitudes of social reinforcement or the extent to which preference is related to differences in reinforcer efficacy. The purpose of the current…

  19. Evaluation of safety and efficacy of silicone rod in tarsofrontalis sling surgery for severe congenital ptosis.

    PubMed

    Rizvi, Syed Ali Raza; Gupta, Yogesh; Yousuf, Snober

    2014-01-01

    To evaluate the efficacy and safety of silicone rod in tarsofrontalis sling surgery for severe congenital ptosis. A prospective, case series study was performed in 46 patients (56 eyelids) who underwent tarsofrontalis sling surgery using silicone rod for severe congenital ptosis. The efficacy of the silicone rod in tarsofrontalis sling surgery was evaluated by marginal reflex distance1 (MRD1), postoperative eyelid symmetry, and recurrence of ptosis. Safety of silicone rod was assessed by noting postoperative complications. The postoperative results were considered as good if MRD1 was 4.0 ± 0.5 mm (3.5-4.5 mm) and symmetry ≤1 mm; fair if MRD1 was 2.5 ± 0.5 mm (2-3 mm) and symmetry 1.5 to 2.0 mm; and poor if MRD1 was <2.0 mm and symmetry <2.0 mm. In cases of unilateral congenital ptosis, good results were seen in 83.3% cases, fair results in 11.1% cases, and poor results in 5.5% cases. In cases of bilateral congenital ptosis, good results were seen in 80.0% cases, fair in 15.0% cases, and poor result in 5.0% cases. Satisfactory postoperative eyelid elevation of ≥2 mm was seen in 93% cases. Complications in the form of granuloma formation, subsequent silicone rod extrusion, and recurrence occurred in 4% cases. The use of silicone rod in tarsofrontalis sling surgery for severe congenital ptosis repair is a safe and effective surgery, with few complications and easy removal and adjustment.

  20. Evaluating the impact of seismic prospecting on artisanal shrimp fisheries

    NASA Astrophysics Data System (ADS)

    Andriguetto-Filho, José M.; Ostrensky, Antonio; Pie, Marcio R.; Silva, Ubiratã A.; Boeger, Walter A.

    2005-09-01

    The constant need to discover new hydrocarbon deposits is causing the use of air-guns to become a very widespread method of seismic prospecting. However, there is still disagreement regarding their impact on the marine environment. This uncertainty is particularly severe in the case of shellfish, which account for a substantial share of commercial fisheries and seafood trade in many parts of the world. In this paper we report on the first study to explicitly assess the impact of seismic prospecting on shrimp resources. We measured bottom trawl yields of a nonselective commercial shrimp fishery comprising the Southern white shrimp, Litopenaeus schmitti, the Southern brown shrimp, Farfantepenaeus subtilis, and the Atlantic Seabob, Xyphopenaeus kroyeri (Decapoda: Penaeidae), before and after the use of an array of four synchronized air-guns, each with 635 in 3 of total capacity, 2.000 psi, and peak pressure of 196 dB (re 1 μPa at 1 m). Our results did not detect significant deleterious impact of seismic prospecting on the studied species, suggesting that shrimp stocks are resilient to the disturbance by air-guns under our experimental conditions.

  1. Reflections and Future Prospects for Evaluation in Human Resource Development

    ERIC Educational Resources Information Center

    Han, Heeyoung; Boulay, David

    2013-01-01

    Human resource development (HRD) evaluation has often been criticized for its limited function in organizational decision making. This article reviews evaluation studies to uncover the current status of HRD evaluation literature. The authors further discuss general evaluation theories in terms of value, use, and evaluator role to extend the…

  2. Reflections and Future Prospects for Evaluation in Human Resource Development

    ERIC Educational Resources Information Center

    Han, Heeyoung; Boulay, David

    2013-01-01

    Human resource development (HRD) evaluation has often been criticized for its limited function in organizational decision making. This article reviews evaluation studies to uncover the current status of HRD evaluation literature. The authors further discuss general evaluation theories in terms of value, use, and evaluator role to extend the…

  3. A Prospective Randomized Controlled Trial of the Efficacy of External Physical Vibration Lithecbole after Extracorporeal Shock Wave Lithotripsy for a Lower Pole Renal Stone Less Than 2 cm.

    PubMed

    Long, Qilai; Zhang, Jian; Xu, Zhibing; Zhu, Yanjun; Liu, Li; Wang, Hang; Guo, Jianming; Wang, Guomin

    2016-04-01

    We evaluate the efficacy and safety of external physical vibration lithecbole in improving the clearance rates of lower pole renal stones after shock wave lithotripsy. A total of 71 patients with lower pole renal stones (6 to 20 mm) were prospectively randomized into 2 groups. In the treatment group 34 patients were treated with external physical vibration lithecbole after shock wave lithotripsy. In the control group 37 patients underwent shock wave lithotripsy only. External physical vibration lithecbole was performed without anesthesia by the same team using the Friend-I External Physical Vibration Lithecbole (Fu Jian Da Medical Instrument Co., Ltd, Zhengzhou, China). The stone-free rate, stone expulsion rate, stone expulsion time and incidence of complications were monitored. External physical vibration lithecbole was successful in assisting the discharge of stone fragments. The stone-free status was 76.5% in the treatment group and 48.6% in the control group (p=0.008). Stone expulsion rates at day 1, week 1 and week 3 were 76.5% (26), 94.1% (32) and 94.1% (32) in the treatment group vs 43.2% (16), 73.0% (27) and 89.2% (33) in the control group, respectively. Mean stone fragment expulsion time was 11.2 minutes in the treatment group and 9.17 hours in the control group (p=0.016). There was no significant difference in complications between the 2 groups (p >0.05). External physical vibration lithecbole was efficacious in assisting the discharge of lower pole renal stone fragments and can be used as an adjunctive method of minimally invasive stone treatment. However, additional investigations are needed to confirm the efficacy. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  4. A prospective study on the efficacy of two-dose influenza vaccinations in cancer patients receiving chemotherapy.

    PubMed

    Sanada, Yukinari; Yakushijin, Kimikazu; Nomura, Tetsuhiko; Chayahara, Naoko; Toyoda, Masanori; Minami, Yosuke; Kiyota, Naomi; Mukohara, Toru; Kawamoto, Shinichiro; Ito, Mitsuhiro; Matsuoka, Hiroshi; Minami, Hironobu

    2016-05-01

    Cancer patients receiving chemotherapy are at risk of acquiring influenza infections. Two-dose vaccination is a proposed strategy for increasing vaccination efficacy; however, this has yet to be confirmed in this population. The purpose of this study was to clarify the efficacy and safety of this strategy. We conducted a multicentre prospective study on a two-dose vaccination regimen in cancer patients receiving chemotherapy. Second vaccinations were performed in patients who did not respond to all three viral strains after the first vaccination. Serum haemagglutination inhibition titres were measured to determine the patients' immunological response, 2 weeks prior to the first vaccination, 3-5 weeks after each vaccination, and at the end of the influenza season. We enrolled 109 patients, including 70 with solid tumours, 36 with haematological malignancies, and 3 with both cancer types. Among the total patients, the proportion of patients with protective titres against the three viral strains increased significantly from 3 to 27% (P < 0.01) following vaccination. Among the 79 patients who received a second vaccination, the proportion of those with protective titres against the individual strains increased by 10% (H1N1), 8% (H3N2), and 3% (B) compared with after the first vaccination. Serious adverse events were not observed. We recommend influenza vaccinations for cancer patients, including those receiving chemotherapy. Also, the additional benefit of the second vaccination may be limited. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  5. Safety and self-reported efficacy of botulinum toxin for adult spasticity in current clinical practice: a prospective observational study.

    PubMed

    Muller, François; Cugy, Emmanuelle; Ducerf, Camille; Delleci, Claire; Guehl, Dominique; Joseph, Pierre-Alain; Burbaud, Pierre; Dehail, Patrick

    2012-02-01

    To determine the safety and the self-reported efficacy of botulinum toxin injections for adult spasticity in current clinical practice. A prospective observational study. A total of 406 adult patients with focal spasticity received of 1136 series botulinum toxin injections at Bordeaux University Hospital from January 2007 to December 2009. Adverse events following botulinum toxin injections were reported. Their severity and the therapeutic efficacy of botulinum toxin injections were estimated with a four-point self-reporting scale (0 to 3). Latency and duration of adverse events and subjective improvement were also noted. The data of 640 series of injections were analyzed. Forty-six (7.2%) adverse events were reported, of which 36 (78%) were local. There were 18 (39%) cases of local muscular weakness with an average duration of 30.0 (SD 38.2) days, and an average severity score of 1.0 (SD 0.97). Among systemic adverse events, there were 8 (17%) cases of excessive fatigue without global muscular weakness and 2 (4%) cases of transitory generalized muscular weakness. The average subjective improvement score was 1.89 (SD 0.97) and was higher for upper, than for lower, limbs (P=0.007). Self-reported adverse events following botulinum toxin injections in spasticity are rare, often benign and of short duration in current clinical practice. Botulinum toxin is considered effective by patients in treating spasticity of the upper and lower limbs.

  6. A prospective randomised trial to compare the efficacy of povidone-iodine 10% and chlorhexidine 2% for skin disinfection

    PubMed Central

    Kulkarni, Atul P; Awode, Rishikesh M

    2013-01-01

    Context: Infectious complications of invasive procedures affect patient outcomes adversely. Choice of antiseptic solution at the time of insertion is one of the major factors affecting their incidence. Aims: This study was undertaken to compare efficacy of chlorhexidine 2% and povidone iodine 10% for skin disinfection prior to placement of epidural and central venous catheters (CVCs). Settings and Design: A prospective randomised trial in the operating rooms of a tertiary referral cancer centre. Methods: Sixty consecutive adult patients undergoing elective oncosurgery requiring placement of epidural and CVCs were enrolled. Paired skin swabs were collected before and after application of the antiseptic solution. The samples were incubated in McConkey's media and blood agar at 35°C for up to 24 h. Any bacterial growth was graded as: <10 colonies - poor growth, 10-50 colonies - moderate growth and >50 colonies as heavy growth. Data on demographics and antibiotic prophylaxis and costs was collected for all patients. Statistical Analysis: Student's t-test and Mann-Whitney tests were used to analyse data, P<0.05 was considered significant. Results: Demographics and antibiotic prophylaxis use was similar in both groups. Before application of antiseptic solution, a variety of micro-organisms were grown from most patients with growth ranging from none-heavy. No organism was grown after application of either antiseptic solution from any patient. Conclusions: We found no differences between 2% chlorhexidine and 10% povidone-iodine for skin disinfection in regard to costs, efficacy or side-effects. PMID:23983286

  7. An ex vivo evaluation of efficacy of refrigerated canine plasma.

    PubMed

    Grochowsky, Adam R; Rozanski, Elizabeth A; de Laforcade, Armelle M; Sharp, Claire R; Meola, Dawn M; Schavone, Jessica J; Brooks, Majory B

    2014-01-01

    To determine thawing times of fresh frozen plasma (FFP), and to evaluate the activity of hemostatic proteins (coagulation factors V, VII, VIII, IX, X, and fibrinogen), clotting times (prothrombin time and activated partial thromboplastin time), and sterility of canine plasma stored refrigerated. Prospective laboratory-based study. Veterinary teaching hospital blood bank. Phase 1: Six units of canine FFP were retrieved from the blood bank and thawed individually in a warm water bath. Time for thaw was recorded in minutes and reported as mean ± SD. Phase 2: One unit of fresh whole blood was collected from 9 dogs and processed routinely. Resulting plasma was divided into 2 aliquots, 1 stored as refrigerated plasma (RP) and 1 as frozen plasma. Samples from the RP were taken at 0, 1, 5, 7, and 14 days and from the FFP at days 0 and 14 for determination of clotting factor activity (V, VII, VIII, IX, and X and fibrinogen) and clotting times. Coagulation factors and clotting times were analyzed using a mixed effects linear model for ANOVA, comparing changes over time as well as differences between groups. For all comparisons, a P value of <0.05 was considered significant. Batch bacterial aerobic and anaerobic cultures of the RP samples were submitted on days 7 and 14 and from the frozen plasma on day 14. Time to thaw for FFP units was 34.7 ± 1.38 minutes. Refrigerated storage resulted in significant decreases in the activity of all clotting factors and a subsequent prolongation in clotting times. However, no values were outside of the reference interval. All bacterial cultures yielded no growth. Refrigerated storage results in only minor loss of coagulation factor activity in canine plasma. The use of RP, therefore, may be a viable option in high-volume veterinary hospitals for rapid correction of coagulopathy in critical care patients. © Veterinary Emergency and Critical Care Society 2014.

  8. Efficacy of Atomoxetine for the Treatment of ADHD Symptoms in Patients with Pervasive Developmental Disorders: A Prospective, Open-Label Study

    ERIC Educational Resources Information Center

    Fernandez-Jaen, Alberto; Fernandez-Mayoralas, Daniel Martin; Calleja-Perez, Beatriz; Munoz-Jareno, Nuria; Campos Diaz, Maria del Rosario; Lopez-Arribas, Sonia

    2013-01-01

    Objective: Atomoxetine's tolerance and efficacy were studied in 24 patients with pervasive developmental disorder and symptoms of ADHD. Method: Prospective, open-label, 16-week study was performed, using the variables of the Clinical Global Impression Scale and the Conners' Scale, among others. Results: A significant difference was found between…

  9. Efficacy of Atomoxetine for the Treatment of ADHD Symptoms in Patients with Pervasive Developmental Disorders: A Prospective, Open-Label Study

    ERIC Educational Resources Information Center

    Fernandez-Jaen, Alberto; Fernandez-Mayoralas, Daniel Martin; Calleja-Perez, Beatriz; Munoz-Jareno, Nuria; Campos Diaz, Maria del Rosario; Lopez-Arribas, Sonia

    2013-01-01

    Objective: Atomoxetine's tolerance and efficacy were studied in 24 patients with pervasive developmental disorder and symptoms of ADHD. Method: Prospective, open-label, 16-week study was performed, using the variables of the Clinical Global Impression Scale and the Conners' Scale, among others. Results: A significant difference was found between…

  10. Effectiveness of an Intervention to Promote Self-Efficacy on Quality of Life of Patients with Nasopharyngeal Carcinoma of the Zhuang Tribe Minority in Guangxi, China: A Prospective Study.

    PubMed

    Lu, Jiamei; Zeng, Xiaofen; Liao, Jinlian; Zhang, Yong; Yang, Li; Li, Yuming; Lv, Jun

    2017-08-23

    BACKGROUND Nasopharyngeal carcinoma (NPC) is endemic in China and patient self-management is poor. Minorities may suffer from psychological problems during treatments for NPC. This study aimed to implement an intervention to promote self-efficacy of minority patients (Zhuang tribe, Guangxi, China) with NPC to improve their quality of life (QOL). MATERIAL AND METHODS This was a prospective study of 120 patients with NPC treated at the First Affiliated Hospital of Guangxi Medical University (Guangxi, China), randomized to conventional care (n=60, controls) or conventional care plus self-efficacy interventions based on health education, behavior therapy, and psychological intervention (n=60, self-efficacy group). Self-efficacy was evaluated using the general self-efficacy scale, and QOL using the EORTC QLQ-C30. The questionnaires were completed at discharge, at 6 months, and at 1 and 2 years. The primary outcome was QOL. RESULTS There was no difference in QOL at baseline. From study start to hospital discharge, overall QOL scores decreased in both groups, but this decrease was more important in the control group (controls: -39.31 vs. self-efficacy: -27.04, P<0.05). After discharge, each functional field QOL scores and overall QOL increased with time in the 2 groups, and they were significantly higher in the self-efficacy group. CONCLUSIONS This intervention promoting self-efficacy could increase patients' own potential and initiative, enhance their confidence and ability to solve health problems, improve their coping with adverse effects of treatments, and have positive effects on their QOL. Self-efficacy theory-based interventions could be worth popularization during the treatment and recovery of minority patients with NPC.

  11. Characterization of mathematics instructional practises for prospective elementary teachers with varying levels of self-efficacy in classroom management and mathematics teaching

    NASA Astrophysics Data System (ADS)

    Lee, Carrie W.; Walkowiak, Temple A.; Nietfeld, John L.

    2017-01-01

    The purpose of this study was to investigate the relationship between prospective teachers' (PTs) instructional practises and their efficacy beliefs in classroom management and mathematics teaching. A sequential, explanatory mixed-methods design was employed. Results from efficacy surveys, implemented with 54 PTs were linked to a sample of teachers' instructional practises during the qualitative phase. In this phase, video-recorded lessons were analysed based on tasks, representations, discourse, and classroom management. Findings indicate that PTs with higher levels of mathematics teaching efficacy taught lessons characterised by tasks of higher cognitive demand, extended student explanations, student-to-student discourse, and explicit connections between representations. Classroom management efficacy seems to bear influence on the utilised grouping structures. These findings support explicit attention to PTs' mathematics teaching and classroom management efficacy throughout teacher preparation and a need for formative feedback to inform development of beliefs about teaching practises.

  12. Characterization of mathematics instructional practises for prospective elementary teachers with varying levels of self-efficacy in classroom management and mathematics teaching

    NASA Astrophysics Data System (ADS)

    Lee, Carrie W.; Walkowiak, Temple A.; Nietfeld, John L.

    2017-03-01

    The purpose of this study was to investigate the relationship between prospective teachers' (PTs) instructional practises and their efficacy beliefs in classroom management and mathematics teaching. A sequential, explanatory mixed-methods design was employed. Results from efficacy surveys, implemented with 54 PTs were linked to a sample of teachers' instructional practises during the qualitative phase. In this phase, video-recorded lessons were analysed based on tasks, representations, discourse, and classroom management. Findings indicate that PTs with higher levels of mathematics teaching efficacy taught lessons characterised by tasks of higher cognitive demand, extended student explanations, student-to-student discourse, and explicit connections between representations. Classroom management efficacy seems to bear influence on the utilised grouping structures. These findings support explicit attention to PTs' mathematics teaching and classroom management efficacy throughout teacher preparation and a need for formative feedback to inform development of beliefs about teaching practises.

  13. Efficacy and Safety Evaluation of a Chlorine Dioxide Solution

    PubMed Central

    Ma, Jui-Wen; Huang, Bin-Syuan; Hsu, Chu-Wei; Peng, Chun-Wei; Cheng, Ming-Long; Kao, Jung-Yie; Way, Tzong-Der; Yin, Hao-Chang; Wang, Shan-Shue

    2017-01-01

    In this study, a chlorine dioxide solution (UC-1) composed of chlorine dioxide was produced using an electrolytic method and subsequently purified using a membrane. UC-1 was determined to contain 2000 ppm of gaseous chlorine dioxide in water. The efficacy and safety of UC-1 were evaluated. The antimicrobial activity was more than 98.2% reduction when UC-1 concentrations were 5 and 20 ppm for bacteria and fungi, respectively. The half maximal inhibitory concentrations (IC50) of H1N1, influenza virus B/TW/71718/04, and EV71 were 84.65 ± 0.64, 95.91 ± 11.61, and 46.39 ± 1.97 ppm, respectively. A 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) test revealed that the cell viability of mouse lung fibroblast L929 cells was 93.7% at a 200 ppm UC-1 concentration that is over that anticipated in routine use. Moreover, 50 ppm UC-1 showed no significant symptoms in a rabbit ocular irritation test. In an inhalation toxicity test, treatment with 20 ppm UC-1 for 24 h showed no abnormality and no mortality in clinical symptoms and normal functioning of the lung and other organs. A ClO2 concentration of up to 40 ppm in drinking water did not show any toxicity in a subchronic oral toxicity test. Herein, UC-1 showed favorable disinfection activity and a higher safety profile tendency than in previous reports. PMID:28327506

  14. Clinical Evaluation of Efficacy of CIA and CNA Intrusion Arches

    PubMed Central

    Vora, Sambhav; Pandey, Vinisha

    2015-01-01

    Background and Objectives Excessive overbite is one of the most common problems that confront the orthodontist. Deep bite can be due to infraocclusion of posterior teeth, supraocclusion of anterior teeth or a combination of the two. Correction of same can be carried out by extrusion of molars, intrusion of incisors or by a combination of both respectively. Various intrusion arches are recommended for correcting deep bite by true intrusion of anterior teeth, Utility arches, Segmental arch, Connecticut Intrusion Arch (CIA) and Connecticut New Arch (CNA). The purpose of this study was to evaluate clinical efficacy of CIA and CNA intrusion arches. Materials and Methods Tracings recorded from pre and post-treatment lateral cephalograms of 25 patients treated by CIA (Group I) and another 25 patients treated by CNA (Group II) intrusion arches in deep bite cases after four months of treatment were analysed and findings were recorded. Statistical Analysis Paired t-test was used to compare pre and post-treatment changes within Groups I and II and unpaired t-test was used to compare treatment changes between Group I and Group II. A P-value of < 0.05 was set for statistical significance. Results Findings of this study demonstrate that an average of 1mm of intrusion takes place with CIA intrusion arch and 1.3mm with CNA intrusion arch in a period of 4 months. Both intrusion arches do not affect the position of molar in vertical or anteroposterior plane. Interpretation & Conclusion Both CIA and CNA intrusion arches are effective in bringing about intrusion of lower incisors. PMID:26501008

  15. National Trauma Institute prospective evaluation of the ventilator bundle in trauma patients: does it really work?

    PubMed

    Croce, Martin A; Brasel, Karen J; Coimbra, Raul; Adams, Charles A; Miller, Preston R; Pasquale, Michael D; McDonald, Chanchai S; Vuthipadadon, Somchan; Fabian, Timothy C; Tolley, Elizabeth A

    2013-02-01

    Since its introduction by the Institute for Healthcare Improvement, the ventilator bundle (VB) has been credited with a reduction in ventilator-associated pneumonia (VAP). The VB consists of stress ulcer prophylaxis, deep venous thrombosis prophylaxis, head-of-bed elevation, and daily sedation vacation with weaning assessment. While there is little compelling evidence that the VB is effective, it has been widely accepted. The Centers for Medical and Medicaid Services has suggested that VAP should be a "never event" and may reduce payment to providers. To provide evidence of its efficacy, the National Trauma Institute organized a prospective multi-institutional trial to evaluate the utility of the VB. This prospective observational multi-institutional study included six Level I trauma centers. Entry criteria required at least 2 days of mechanical ventilation of trauma patients in an intensive care unit (ICU). Patients were followed up daily in the ICU until the development of VAP, ICU discharge, or death. Compliance for each VB component was recorded daily, along with patient risk factors and injury specifics. Primary outcomes were VAP and death. VB compliance was analyzed as a time-dependent covariate using Cox regression as it relates to outcomes. A total 630 patients were enrolled; 72% were male, predominately with blunt injury; and mean age, Injury Severity Score (ISS), and 24-hour Glasgow Coma Scale (GCS) score were 47, 24, and 8.7, respectively. VAP occurred in 36%; mortality was 15%. Logistic regression identified male sex and pulmonary contusion as independent predictors of VAP and age, ISS, and 24-hour Acute Physiology and Chronic Health Evaluation as independent predictors of death. Cox regression analysis demonstrated that the VB, as a time-dependent covariate, was not associated with VAP prevention. In trauma patients, VAP is independently associated with male sex and chest injury severity and not the VB. While quality improvement activities should

  16. Field evaluation of measles vaccine efficacy in Mozambique.

    PubMed

    Cutts, F T; Smith, P G; Colombo, S; Mann, G; Ascherio, A; Soares, A C

    1990-02-01

    Monitoring measles vaccine efficacy is an important form of quality control in immunization programs. Retrospective cohort studies of vaccine efficacy were conducted in Mozambique with the aim of adopting this method for regular use. The authors studied 1,215 and 790 children aged 12-35 months in the cities of Nampula and Beira, respectively. In Nampula (1985), vaccine efficacy was estimated to be 40%, and in Beira (1986), it was estimated to be 59%. To investigate the possibility of falsely low results due to poor specificity of maternal reporting of measles cases, a seroepidemiologic study of 600 children aged 12-47 months was conducted in Nampula in 1986. The specificity and sensitivity of a maternal history of measles in an unvaccinated child were estimated as 83% and 56%, respectively. These results were used to obtain an adjusted vaccine efficacy estimate of 66%, almost double the estimate of 37% obtained using data on history of vaccination and illness alone. The large bias introduced into the vaccine efficacy estimation by low specificity of disease diagnosis is a serious limitation to the use of retrospective cohort methods to assess efficacy.

  17. Efficacy of Epley's Maneuver in Treating BPPV Patients: A Prospective Observational Study

    PubMed Central

    Gaur, Sushil; Awasthi, Sanjeev Kumar; Bhadouriya, Sunil Kumar Singh; Saxena, Rohit; Pathak, Vivek Kumar; Bisht, Mamta

    2015-01-01

    Vertigo and balance disorders are among the most common symptoms encountered in patients who visit ENT outpatient department. This is associated with risk of falling and is compounded in elderly persons with other neurologic deficits and chronic medical problems. BPPV is the most common cause of peripheral vertigo. BPPV is a common vestibular disorder leading to significant morbidity, psychosocial impact, and medical costs. The objective of Epley's maneuver, which is noninvasive, inexpensive, and easily administered, is to move the canaliths out of the canal to the utricle where they no longer affect the canal dynamics. Our study aims to analyze the response to Epley's maneuver in a series of patients with posterior canal BPPV and compares the results with those treated exclusively by medical management alone. Even though many studies have been conducted to prove the efficacy of this maneuver, this study reinforces the validity of Epley's maneuver by comparison with the medical management. PMID:26495002

  18. An evaluation of the efficacy of microvascular breast reconstruction techniques.

    PubMed

    Dobrut, Mirosław; Maciejewski, Adam; Półtorak, Stanisław

    2013-01-01

    The aim of the study was to evaluate the efficacy of different microvascular techniques in breast reconstruction with the analysis of postoperative complications. The additional goal of the study is to analyze the quality of life of patients after microvascular breast reconstruction in comparison to the control group of patients who underwent only mastectomy without any reconstructive procedures. Also the algorithm of breast reconstruction is presented as the result of own experiences. Clinical material contain 2 groups of patients - women after surgical treatment in Department of Oncological and Reconstructive Surgery, Cancer Center in Gliwice in the year 2004-2009 where in 53 cases immediate and in 26 delayed breast microvascular reconstruction were performed. In all cases the diagnosis of cancer was proved by histopathological biopsy before the treatment. The type of radical resection (mastectomy) depended on histopathological type of cancer and its localization. The reconstruction - immediate vs delayed was carefully planned together with oncological treatment of the cases. Everywhere this plan was established based on carefully examinations of inferior epigastric vessels and theirs perforators. The choice between immediate and delayed microvascular reconstruction was based on prognosis and predictive factors. The QOL was analyzed due to own questionnaire when functional, aesthetics and social effects were evaluated. Free flap survival rate for all types of free flap was 95%. In cases where classic TRAM was used the rate was 85%, in cases where muscle sparring TRAM was chosen the survival rate was 100% and in remaining cases of DIEP reconstructions the rate was 89%. Generally the complications after microvascular reconstruction occurred in 13 cases (16%). In 9 cases the problems with flaps perfusion were notified. Total flap necrosis was observed in 2 TRAM and in 2 DIEP cases. In all those cases salvage surgery was administered in which the microanastomoses

  19. In vitro models for evaluating safety and efficacy of novel technologies for skin drug delivery.

    PubMed

    Planz, Viktoria; Lehr, Claus-Michael; Windbergs, Maike

    2016-11-28

    For preclinical testing of novel therapeutics, predictive in vitro models of the human skin are required to assess efficacy, absorption and safety. Simple as well as more sophisticated three-dimensional organotypic models of the human skin emerged as versatile and powerful tools simulating healthy as well as diseased skin states. Besides addressing the demands of research and industry, such models serve as valid alternative to animal testing. Recently, the acceptance of several models by regulatory authorities corroborates their role as important building block for preclinical development. However, valid assessment of readout parameters derived from these models requires suitable analytical techniques. Standard analytical methods are mostly destructive and limited regarding in-depth investigation on molecular level. The combination of adequate in vitro models with modern non-invasive analytical modalities bears a great potential to address important skin drug delivery related questions. Topics of interest are for instance the assessment of repeated dosing effects and xenobiotic biotransformation, which cannot be analyzed by destructive techniques. This review provides a comprehensive overview of current in vitro skin models differing in functional complexity and mimicking healthy as well as diseased skin states. Further, benefits and limitations regarding analytical evaluation of efficacy, absorption and safety of novel drug carrier systems applied to such models are discussed along with a prospective view of anticipated future directions. In addition, emerging non-invasive imaging modalities are introduced and their significance and potential to advance current knowledge in the field of skin drug delivery is explored. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Evaluation and Municipal Urban Planning: Practice and Prospects.

    ERIC Educational Resources Information Center

    Seasons, Mark

    2002-01-01

    Explored the state of evaluation practice, including monitoring, in planning departments in 14 municipalities of regional scale and style in Ontario, Canada. Compared applications of evaluation in planning practice with generic evaluation practice and identified critical determinants of success through qualitative research methods. (SLD)

  1. Efficacy and Tolerability of Solifenacin 5 mg Fixed Dose in Korean Children with Newly Diagnosed Idiopathic Overactive Bladder: a Multicenter Prospective Study

    PubMed Central

    2017-01-01

    We investigated the efficacy and tolerability of solifenacin 5 mg fixed dose in children with newly diagnosed idiopathic overactive bladder (OAB). A total of 34 children (male/female patients = 16/18) aged under 13 years (mean age: 7.2 ± 2.3; range: 5–12) who were newly diagnosed with OAB from January 2012 to September 2014 were prospectively evaluated with open-label protocol. All patients were treated with solifenacin 5 mg fixed dose once daily for at least 4 weeks. The efficacy and tolerability of solifenacin were evaluated 4, 8, and 12 weeks after the initiation of treatment. The mean voiding frequency during daytime was decreased from 9.4 ± 3.0 to 6.5 ± 2.3 times after the 12-week treatment (P < 0.001). The mean total OAB symptom score (OABSS) decreased from 7.7 ± 4.2 to 3.1 ± 3.1 after the 12-week treatment (P < 0.001). The urgency and urgency urinary incontinence (UUI) domains significantly improved from the 12-week treatment, and complete resolution of urgency occurred in 38.9% of patients and the percentage of children with UUI among urgent patients decreased from 79.4% to 57.1%. According to 3-day voiding diaries, the average bladder capacity increased from 90.4 ± 44.4 to 156.2 ± 67.3 mL (P < 0.001). Drug-induced adverse effects (AEs) were reported in 7 patients (20.6%). Our results indicate that solifenacin 5 mg fixed dose is effective against OAB symptoms, and its tolerability is acceptable without significant AEs in children with OAB. PMID:28049246

  2. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study.

    PubMed

    Goldstein, Rachel Y; Montero, Nicole; Jain, Sudheer K; Egol, Kenneth A; Tejwani, Nirmal C

    2012-10-01

    To compare postoperative pain control in patients treated surgically for ankle fractures who receive popliteal blocks with those who received general anesthesia alone. Institutional Review Board approved prospective randomized study. Metropolitan tertiary-care referral center. All patients being treated with open reduction internal fixation for ankle fractures who met inclusion criteria and consented to participate were enrolled. Patients were randomized to receive either general anesthesia (GETA) or intravenous sedation and popliteal block. Patients were assessed for duration of procedure, total time in the operating room, and postoperative pain at 2, 4, 8, 12, 24, and 48 hours after surgery using a visual analog scale. Fifty-one patients agreed to participate in the study. Twenty-five patients received popliteal block, while 26 patients received GETA. There were no anesthesia-related complications. At 2, 4, and 8 hours postoperatively, patients who underwent GETA demonstrated significantly higher pain. At 12 hours, there was no significant difference between the 2 groups with regard to pain control. However, by 24 hours, those who had received popliteal blocks had significantly higher pain with no difference by 48 hours. Popliteal block provides equivalent postoperative pain control to general anesthesia alone in patients undergoing operative fixation of ankle fractures. However, patients who receive popliteal blocks do experience a significant increase in pain between 12 and 24 hours. Recognition of this "rebound pain" with early narcotic administration may allow patients to have more effective postoperative pain control.

  3. Vagus nerve stimulation for depression: rationale, anatomical and physiological basis of efficacy and future prospects.

    PubMed

    Park, M C; Goldman, M A; Carpenter, L L; Price, L H; Friehs, G M

    2007-01-01

    Treatment-resistant depression (TRD) is a major public health concern due to its high costs to society. One of the novel approaches for the treatment of depression is the vagus nerve stimulation (VNS). Therapeutic brain stimulation through delivery of pulsed electrical impulses to the left cervical vagus nerve now has established safety and efficacy as an adjunct treatment for medication-resistant epilepsy and has recently been approved as an adjunct long-term treatment for chronic or recurrent depression. There is considerable evidence from both animal and human neurochemical and neuroimaging studies, that the vagus nerve and its stimulation influence limbic and higher cortical brain regions implicated in mood disorders, providing a rationale for its possible role in the treatment of psychiatric disorders. Clinical studies (open-label and comparator with treatment in naturalistic setting) in patients with TRD have produced promising results, especially when the response rates at longer-term (one- and two-year) follow-up time points are considered. Ongoing research efforts will help determine the place of VNS in the armament of therapeutic modalities available for major depression.

  4. Checklists for the Evaluation of Educational Software: Critical Review and Prospects.

    ERIC Educational Resources Information Center

    Tergan, Sigmar-Olaf

    1998-01-01

    Reviews strengths and weaknesses of check lists for the evaluation of computer software and outlines consequences for their practical application. Suggests an approach based on an instructional design model and a comprehensive framework to cope with problems of validity and predictive power of software evaluation. Discusses prospects of the…

  5. 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…

  6. 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…

  7. Prospective Trial of Efficacy and Safety of Ondansetron and Fluoxetine in Patients with Obstructive Sleep Apnea Syndrome

    PubMed Central

    Prasad, Bharati; Radulovacki, Miodrag; Olopade, Christopher; Herdegen, James J.; Logan, Thomas; Carley, David W.

    2010-01-01

    Study Objective: Incremental withdrawal of serotonin during wake to sleep transition is postulated as a key mechanism that renders the pharyngeal airway collapsible. While serotonin promotion with reuptake inhibitors have demonstrated modest beneficial effects during NREM sleep on obstructive sleep apnea (OSA), animal studies suggest a potential therapeutic role for selective serotonin receptor antagonists (5-HT3) in REM sleep. We aimed to test the hypothesis that a combination of ondansetron (Ond) and fluoxetine (Fl) may effectively reduce expression of disordered breathing during REM and NREM sleep in patients with OSA. Design and Setting: A prospective, parallel-groups, single-center trial in patients with OSA. Participants: 35 adults with apnea hypopnea index (AHI) > 10; range 10-98. Intervention: Subjects were randomized to placebo, n = 7; Ond (24 mg QD), n = 9; Fl (5 mg QD) + Ond (12 mg QD), n = 9; and Fl (10 mg QD) + Ond (24 mg QD), n = 10. Measurements and Results: AHI was measured by in-lab polysomnography after a 7-day no-treatment period (Baseline) and on days 14 and 28 of treatment. The primary endpoint was AHI reduction at days 14 and 28. OND+FL resulted in approximately 40% reduction of baseline AHI at days 14 and 28 (unadjusted P < 0.03 for each) and improved oximetry trends. This treatment-associated relative reduction in AHI was also observed in REM and supine sleep. Conclusions: Combined treatment with OND+FL is well-tolerated and reduces AHI, yielding a potentially therapeutic response in some subjects with OSA. Citation: Prasad B; Radulovacki M; Olopade C; Herdegen JJ; Logan T; Carley DW. Prospective trial of efficacy and safety of ondansetron and fluoxetine in patients with obstructive sleep apnea syndrome. SLEEP 2010;33(7):982-989. PMID:20614859

  8. Efficacy and safety of fosfomycin-trometamol in the prophylaxis for transrectal prostate biopsy. Prospective randomized comparison with ciprofloxacin.

    PubMed

    Lista, F; Redondo, C; Meilán, E; García-Tello, A; Ramón de Fata, F; Angulo, J C

    2014-01-01

    Prostate biopsy is the standardized diagnostic method for prostate cancer. However, although there is not a standardized protocol, there are recommendations in order to reduce the incidence of complications. The objective of the present work is to assess the efficacy and safety of antibiotic prophylaxis in the prostate biopsy by comparing two antibiotic regimes: two doses of fosfomycin-trometamol 3g (FMT) every 48 hours with 10 doses of oral ciprofloxacin 500 mg every 12 hours during 5 days. Randomized prospective study was performed with 671 patients who had undergone to walking transrectal ultrasound guided prostate biopsy. Patients of group A (n=312) were treated with ciprofloxacin, and patients of group B (n=359) with FMT. Efficacy and tolerability of two prophylactic regimes were compared. Urine culture was carried out at 2 weeks after biopsy. Initially, patients with asymptomatic bacteriuria were not treated with antibiotics; urine culture was repeated after 1 month, persistent bacteriuria was treated according to antibiogram. No differences between groups were found in age (P=.78), cancer presence (P=.9) or number of biopsy cylinders (P=.93). The mean number of cores obtained was 11.3 ± 3.25 (range 6-20). Digestive intolerance was observed for 9 patients (2.9%) of group A and 10 patients (2.8%) in group B. One patient (.3%) of group A showed severe allergic reaction. In total, 167 patients (24.6%) had complications: 16 (2.4%) fever, 47 (6.9%) hemospermia, 81 (11.9%) hematuria, 7 (1%) rectal bleeding and 16 (2.4%) urinary retention. No statistically differences between groups were observed (27.6% vs. 22.6%; P=.17). However, hemospermia was more frequent in group A (9.9% vs. 4.5%; P=.006). Bacteriuria after biopsy was detected in 44 patients (6.6%), being more frequent in group B patients (4.2% vs. 8.6%; P=.02) although a higher number of second treatment cycles were not needed (53.9% vs. 29%; P=.17). The likelihood of resistance to ciprofloxacin in patients

  9. Efficacy and safety of acetylcysteine in "non-acetaminophen" acute liver failure: A meta-analysis of prospective clinical trials.

    PubMed

    Hu, Jinhua; Zhang, Qizhi; Ren, Xingye; Sun, Ziqin; Quan, Qizhen

    2015-10-01

    Acute liver failure (ALF) is a rare but highly mortal condition without liver transplantation (LT). N-acetylcysteine (NAC), a glutathione precursor that detoxifies the reactive metabolite of acetaminophen and replenishes hepatic glutathione stores, is a highly effective drug for the prevention of ALF caused by acetaminophen. However, therapeutic use of NAC in non-acetaminophen-induced ALF (NAI-ALF) including alcohol intoxication, hepatitis virus infection, or drug and toxin-related hepatotoxicity is still inconclusive. The aim of this article is using meta-analysis method to analyze recent prospective clinical trials for the safety and efficacy of NAC in patients with ALF not caused by acetaminophen poisoning. Prospective clinical trials comparing efficacy and safety between NAC and control in the treatment of NAI-ALF were identified by searching Pubmed (2000-2014) and EMBASE (2000-2014) using the search terms acetylcysteine or NAC and NAI-ALF. The primary outcome was overall survival. Secondary outcomes included liver transplantation-free survival, post transplantation survival, length of ICU and hospital stays, and the relationship with coma grade. The safety profiles were also analyzed. Four clinical trials were selected for meta-analysis. A total of 331 patients receiving treatment with NAC (oral or intravenously) and 285 patients in control group were included for meta-analysis. No statistical difference was identified between NAC group and control group for overall survival [236/331 (71%) vs 191/285 (67%); 95% CI 1.16 (0.81-1.67); P=0.42]. However, there were significant differences between NAC group and control group regarding the survival with native liver [112/273 (41%) vs 68/226 (30%); 95% CI 1.61 (1.11-2.34); P=0.01] and post-transplantation survival [78/91 (85.7%) vs 50/70 (71.4%); 95% CI 2.44 (1.11-5.37); P=0.03]. The identified side effects of NAC included nausea, vomiting, and diarrhea or constipation. Rarely, it could cause rashes, fever, headache

  10. Predictors of opioid efficacy in patients with chronic pain: A prospective multicenter observational cohort study

    PubMed Central

    Olesen, Anne E.; Gram, Mikkel; Jonsson, Torsten; Kamp-Jensen, Michael; Andresen, Trine; Nielsen, Christian; Pozlep, Gorazd; Pfeiffer-Jensen, Mogens; Morlion, Bart; Drewes, Asbjørn M.

    2017-01-01

    Opioids are increasingly used for treatment of chronic pain. However, they are only effective in a subset of patients and have multiple side effects. Thus, studies using biomarkers for response are highly warranted. The current study prospectively examined 63 opioid-naïve patients initiating opioid use for diverse types of chronic pain at five European centers. Quantitative sensory testing, electroencephalography (EEG) recordings, and assessment of pain catastrophizing were performed prior to treatment. The co-primary outcomes were change from baseline in ratings of chronic pain and quality of life after 14 days of opioid treatment. Secondary outcomes included patient’s global impression of clinical change and side effects. Logistic regression models adjusted for age and sex were used to identify biomarkers predictive for successful treatment, defined as at least a 30% reduction in average pain intensity or an improvement in quality of life of at least 10 scale points. Fifty-nine patients (94%) completed the study. The mean age was 55 ± 16 years and 69% were females. Pain reduction was predicted by cold pain intensity (OR: 0.69; P = 0.01), pain catastrophizing (OR: 0.82; P = 0.03), relative delta (OR: 0.76; P = 0.03) and beta EEG activity (OR: 1.18; P = 0.04) induced by experimental cold pain. None of the study variables were related to improvement in quality of life. For the first time, individual pain processing characteristics have been linked to opioid response in a mixed chronic pain population. This has the potential to personalize treatment of chronic pain and restrict opioid use to patients with high likelihood for response. PMID:28158269

  11. Efficacy of a new hemostatic forceps during gastric endoscopic submucosal dissection: A prospective randomized controlled trial.

    PubMed

    Tanaka, Shinwa; Toyonaga, Takashi; Morita, Yoshinori; Ishida, Tsukasa; Hoshi, Namiko; Grimes, Kevin L; Ohara, Yoshiko; Yoshizaki, Tetsuya; Kawara, Fumiaki; Umegaki, Eiji; Azuma, Takeshi

    2017-04-01

    Currently, endoscopic submucosal dissection (ESD) is a widely accepted standard treatment for early gastric cancer, but one challenging aspect of ESD is hemostasis. We developed a new hemostatic forceps (FD-Y0007) with the aim of achieving more effective hemostasis and investigated the hemostatic ability of the FD-Y0007 during gastric ESD in humans. This study was a prospective randomized controlled trial, which was conducted at a cancer referral center. Sixty-six patients who were scheduled to undergo ESD were enrolled and randomly assigned to either the Coagrasper or the FD-Y0007, which was used for hemostasis throughout the case. The primary end point was the time required to obtain hemostasis, which was measured for the first episode of bleeding during each case. Hemostasis time for the first bleeding episode during ESD was 73.0 s for the Coagrasper and 21.5 s for the FD-Y0007 (P < 0.001). When all episodes of bleeding were included, hemostasis time was 56.8 s in the Coagrasper group and 25.5 s in FD-Y0007group (P < 0.0001). The frequency of adverse events (perforation: 3.4% vs 7.1%; delayed bleeding: 0% vs 0%) was not significantly different between the two groups. Compared with the Coagrasper, the FD-Y0007 efficiently reduces the hemostatic time during gastric ESD with no increase in adverse events. © 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  12. Treatment efficacy of a titratable oral appliance in obstructive sleep apnea patients: a prospective clinical trial.

    PubMed

    Van Haesendonck, G; Dieltjens, M; Hamans, E; Braem, M J; Vanderveken, O M

    2016-01-01

    This prospective clinical trial assessed the therapeutic outcomes of patients with obstructive sleep apnea (OSA) treated with a novel duobloc custom-made titratable mandibular advancement device (OAm). The modular Somnomed G2® OAm (Somnomed Europe AG, Zurich, Switzerland) with 'click-to-fit' adjustability provides instant feedback on the mandibular advancement. 161 consecutive patients with established diagnoses of OSA. Dental impressions were made and a bite registration in 75% of the maximal protrusion being the starting protrusion. Treatment response was defined as ≥ 50% decrease in apnea-hypopnea index (AHI). Treatment success was defined as 1a) AHI with OAm < 5 events/h sleep or 1b) AHI with OAm < 10 events/h. Treatment success and response were combined to define additional criteria: 2a) reduction in AHI ≥ 50% and AHI < 5 events/h; and 2b) reduction in AHI ≥ 50% and AHI <10 events/h. In 112 patients AHI decreased significantly from 25 ± 18/h sleep at baseline to 12 ± 13/h with the OAm (p < 0.001). The visual analogue scoring for snoring (VAS) decreased significantly from 7 ± 3 to 2 ± 2 (p < 0.001). Treatment response was achieved in 65 of 112 patients (58%); 31% and 57% of patients were treated successfully according to criteria 1a and 1b, respectively. Furthermore, 31% and 50% of patients were treated successfully according to criteria 2a and 2b, respectively. This clinical trial indicates that treatment with a novel custom-made OAm can reduce the severity of sleep-disordered breathing by significantly decreasing the AHI and VAS scores.

  13. Teaching Evaluation of Higher Education Institutions: Retrospect and Prospect

    ERIC Educational Resources Information Center

    Siping, Gao

    2009-01-01

    China started up pilot projects for the evaluation of teaching work at regular higher education institutions (HEIs) in 1994, and, beginning in 2003, the Ministry of Education (MOE) formally set up a system of cyclical teaching evaluation. Among the 592 undergraduate colleges and universities that were listed in the plan for the first round of…

  14. Reevaluation of and Prospects for Undergraduate Teaching and Learning Evaluation

    ERIC Educational Resources Information Center

    Yanbao, Li; Xiaomei, Li; Qiongfei, Qu

    2009-01-01

    Begun in 2003, the National Undergraduate Teaching and Learning Evaluation, conducted in regular universities every five years, has surveyed the significance of evaluation and index scheme improvement at 171 higher education institutions. The launch in January 2007 of the national project of Undergraduate Teaching Quality and Teaching Reform in…

  15. Evaluation of the Efficacy of Methyl Bromide in the ...

    EPA Pesticide Factsheets

    Journal Article The objective of this article is to determine the required conditions for the effective inactivation of Bacillus anthracis (B.a.) spores on materials using methyl bromide (MeBr) and to obtain comparative efficacy data with three avirulent microorganisms, to assess their potential as surrogates for B.a. Ames.

  16. Evaluation of the Efficacy of Methyl Bromide in the ...

    EPA Pesticide Factsheets

    Journal Article The objective of this article is to determine the required conditions for the effective inactivation of Bacillus anthracis (B.a.) spores on materials using methyl bromide (MeBr) and to obtain comparative efficacy data with three avirulent microorganisms, to assess their potential as surrogates for B.a. Ames.

  17. Prospective Evaluation of Risk Factors for Male Breast Cancer

    PubMed Central

    Richesson, Douglas A.; Gierach, Gretchen L.; Lacey, James V.; Park, Yikyung; Hollenbeck, Albert R.; Schatzkin, Arthur

    2008-01-01

    Most risk factors for male breast cancer have been derived from retrospective studies that may reflect selective recall. In the prospective National Institutes of Health–AARP Diet and Health Study, we studied 324 920 men, among whom 121 developed breast cancer. Men who reported a first-degree relative with breast cancer had an increased risk of breast cancer (relative risk [RR] = 1.92, 95% confidence interval [CI] = 1.19 to 3.09). Among the medical conditions examined, a new finding emerged regarding increased male breast cancer risk associated with a history of a bone fracture (RR = 2.20, 95% CI = 1.24 to 3.91). Obesity was positively related to risk (RR = 1.79, 95% CI = 1.10 to 2.91, for body mass indices of ≥30 vs <25 kg/m2) and physical activity inversely related, even after adjustment for body mass index. Smokers were at somewhat elevated risk, although trends with smoking characteristics were inconsistent. Alcohol consumption was not related to risk. The identified risk factors show some commonalities with female breast cancer and indicate the importance of hormonal mechanisms. Differences in risk factors may reflect unique mechanisms associated with androgens and their ratio to bioavailable estrogens. PMID:18840816

  18. Efficacy of a Self-Management Program for Childhood Asthma-A Prospective controlled Study.

    ERIC Educational Resources Information Center

    Gebert, N.; Hummelink, R.; Konning, J.; Staab, D.; Schmidt, S.; Szczepanski, R; Rundex, B.; Wahn, U.

    1998-01-01

    Evaluates two training programs for asthmatic children, aged 7-14. The first group consisted of patients and their parents who participated in a five-day standardized family-oriented clinical asthma training program followed by monthly training sessions. The second group omitted these follow-up interventions. Results indicate that the first group…

  19. A prospective randomised controlled study on efficacies of acupuncture and steroid in treatment of idiopathic peripheral facial paralysis.

    PubMed

    Tong, Fu Man; Chow, Shun Kit; Chan, Patrick Yiu Bong; Wong, Alex Kam Wah; Wan, Sambo Shuk Ying; Ng, Rebecca Ka Wah; Chan, Geoffrey; Chan, Wing Shan; Ng, Angela; Law, Chi Keung

    2009-12-01

    A randomised controlled trial was undertaken to evaluate the efficacy of acupuncture in comparison with steroid in treatment of idiopathic peripheral facial paralysis (Bell's palsy). A total of 119 patients attending Ear, Nose and Throat Clinic of Pamela Youde Nethersole Eastern Hospital from February 2003 to December 2005 were randomly allocated to groups of acupuncture, steroid and control (conventional expectant treatment). There were 53 in the steroid group, 28 in the acupuncture group and 38 in the control group. Patients were assessed weekly by blinded assessors, using the House-Brackmann facial nerve grading system. The efficacy of treatment in three groups was compared, in terms of degree of recovery and speed of recovery. Intention-to-treat analyses were performed. Results were analysed with SPSS software. Distribution of initial grade on presentation was analysed with the Pearson chi-square test and showed uneven distribution in the three groups in the intention-to-treat analysis. The overall improvement (grade 3 or better) was 86.9% in the steroid group, 96.4% in the acupuncture group and 89.5% in the control group respectively. However, the difference in degree of recovery and speed of recovery in the three groups was not statistically significant. The efficacies of acupuncture, steroid and conventional expectant treatment (natural course of recovery) in idiopathic peripheral facial palsy (Bell's palsy) in the study were the same with respect to the degree of recovery and speed of recovery.

  20. The efficacy of the interferon-γ release assay for diagnosing cervical tuberculous lymphadenitis: A prospective controlled study.

    PubMed

    Kim, Kyung Hee; Kim, Rock Bum; Woo, Seung Hoon

    2016-02-01

    The whole-blood interferon (IFN)-γ release assay (IGRA) has been studied mainly for diagnosing latent tuberculosis (TB). We prospectively evaluated its diagnostic usefulness in patients with suspected cervical TB lymphadenitis. Prospective cohort study. An IGRA was performed in subjects with suspected TB lymphadenitis. To evaluate the diagnostic performance of the IGRA, we calculated the sensitivity and specificity of culture, radiologic imaging, polymerase chain reaction testing, fine needle aspiration, and excisional biopsy. Of the 271 adult patients with suspected TB lymphadenitis, 42 were diagnosed with the disease. The overall sensitivity and specificity of the IGRA were 78.8% and 95.5%, respectively. When the cutoff value of IFN-γ was set to 0.26 IU/mL, it met the inclusion criteria for suspicious TB lymphadenitis, with sensitivity and specificity of 83.3% and 95.1%, respectively. The IGRA is useful in diagnosing TB lymphadenitis, with high sensitivity and specificity. 4. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

  1. Safety and efficacy of the modified peroral endoscopic myotomy with shorter myotomy for achalasia patients: a prospective study.

    PubMed

    Wang, J; Tan, N; Xiao, Y; Chen, J; Chen, B; Ma, Z; Zhang, D; Chen, M; Cui, Y

    2015-01-01

    Peroral endoscopic myotomy (POEM) has been developed as a minimally invasive endoscopic treatment for achalasia for years. However, the optimal length of submucosal tunnel and myotomy of muscle bundles during procedure of POEM has not yet been determined, so we aim to assess safety and efficacy of modified POEM with shorter myotomy of muscle bundles in achalasia patients. Consecutive achalasia patients had been performed modified POEM with shorter myotomy, and assessed by symptoms, high-resolution manometry, and barium swallow examinations before and 3 months after POEM for safety and efficacy evaluation. Modified POEM with shorter submucosal tunnel (mean length 6.8 cm) and endoscopic myotomy of muscle bundles (total mean length 5.4 cm) were completed in 46 consecutive achalasia patients. During the 3-month follow up in all cases, significant improvement of symptoms (a significant drop in the Eckardt score 8.4 ± 3.2 vs. 2.7 ± 1.9; P < 0.001), decreased lower esophageal sphincter pressure (39.4 ± 10.1 vs. 24.4 ± 9.1 mmHg; P < 0.001) and integrated relaxation pressure (38.6 ± 10.4 vs. 25.7 ± 9.6 mmHg; P < 0.01), and a drop in height of esophagus barium-contrast column (5.4 ± 3.1 vs. 2.6 ± 1.8 cm; P < 0.001) were observed. The frequencies of adverse events were lower in those under endotracheal anesthesia and CO2 insufflations compared with intravenous anesthesia and air insufflations. Only three patients were found to have gastroesophageal reflux disease on follow up. Modified POEM with shorter myotomy under endotracheal anesthesia and CO2 insufflations shows its good safety and excellent short-term efficacy in the treatment of achalasia. But further studies are warranted to assess the long-term efficacy.

  2. Efficacy and safety of telbivudine treatment: an open-label, prospective study in pregnant women for the prevention of perinatal transmission of hepatitis B virus infection.

    PubMed

    Han, G-R; Jiang, H-X; Yue, X; Ding, Y; Wang, C-M; Wang, G-J; Yang, Y-F

    2015-09-01

    We evaluated the efficacy and safety of telbivudine (LdT, 600 mg/day) vs control patients (no treatment) in decreasing vertical transmission of HBV, in HBeAg-positive mothers (HBVDNA >6log(10) copies/mL). HBeAg-positive pregnant women either in the second or third trimester were recruited in a prospective, case-control, open-label study, at the Second Affiliated Hospital of the Southeast University, China (February 2008-December 2010). Efficacy (month 7: HBVDNA (+), HBsAg (+) infants) in either the overall group or the treated group and control group was analysed using student's t-test. Infants were followed for at least 1 year. 362 women received LdT (second trimester n = 257; third trimester n = 105) and 92 were untreated. Before delivery, the mean maternal HBVDNA was 2.73, 2.47, 3.34 and 7.94 log10 copies/mL in the overall, second and third trimester treated and control groups, respectively (P < 0.001). At birth, 11.8% of babies overall (43/365), 13.5% (35/259) of those treated in the second trimester, 7.5% of those treated in the third trimester (8/106) and 20.7% (19/92) of untreated infants were HBsAg positive. At month 7, none of the LdT-treated infant had detectable HBVDNA, while eight infants from control mothers were HBsAg positive. Vertical transmission was 0% in LdT treated and 9.3% (8/86) in the control groups (P < 0.001). No difference in the vertical transmission rate was found in mothers treated in the second or third trimester. LdT treatment was safe for mothers and infants, and no congenital deformities were reported.

  3. 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.

  4. Prospective study of the microbiological flora of hearing aid moulds and the efficacy of current cleaning techniques.

    PubMed

    Ahmad, N; Etheridge, C; Farrington, M; Baguley, D M

    2007-02-01

    Wearing hearing aid earmoulds has been implicated as a predisposing factor in the development of chronic otitis externa. Audiologists come into contact with a large number of hearing aid earmoulds and these could potentially harbour pathogenic micro-organisms, with the risk of subsequent cross infection. Cleaning with dilute alcohol is widely used in an attempt to break the chain of infection. To determine the presence and nature of microbial flora on hearing aid earmoulds and the efficacy of cleaning methods used to prevent cross infection. Secondary health care within the audiology department of Addenbrooke's Hospital, Cambridge, UK. A prospective, observational study. Hearing aid earmoulds were swabbed before and after cleaning. Samples were cultured to determine qualitatively and quantitatively the microbiological flora present before and after cleaning. Twenty out of 21 (95 per cent) earmoulds had microbes present and, of these, 19/20 (95 per cent) had a polymicrobial profile. Coagulase negative staphylococci and diphtheroids were the most frequent microbial isolates, but pathogenic bacteria and fungi were also demonstrated on earmoulds both before and after cleaning. The polymicrobial flora, including recognized pathogens, that colonizes earmoulds may lead to chronic otitis externa. Cleaning with 70 per cent alcohol solution was ineffective, in particular for pathogenic fungi on earmoulds.

  5. Laparoscopic inguinal hernia repair: a prospective evaluation at Eastern Nepal

    PubMed Central

    Shakya, Vikal Chandra; Sood, Shasank; Bhattarai, Bal Krishna; Agrawal, Chandra Shekhar; Adhikary, Shailesh

    2014-01-01

    Introduction Inguinal hernias have been treated traditionally with open methods of herniorrhaphy or hernioplasty. But the trends have changed in the last decade with the introduction of minimal access surgery. Methods This study was a prospective descriptive study in patients presenting to Surgery Department of B. P. Koirala Institute of Health Sciences, Dharan, Nepal with reducible inguinal hernias from January 2011 to June 2012. All patients >18 years of age presenting with inguinal hernias were given the choice of laparoscopic repair or open repair. Those who opted for laparoscopic repair were included in the study. Results There were 50 patients, age ranged from 18 to 71 years with 34 being median age at presentation. In 41 patients, totally extraperitoneal repair was attempted. Of these, 2 (4%) repairs were converted to transabdominal repair and 2 to open mesh repair (4%). In 9 patients, transabdominal repair was done. The median total hospital stay was 4 days (range 3-32 days), the mean postoperative stay was 3.38±3.14 days (range 2-23 days), average time taken for full ambulation postoperatively was 2.05±1.39 days (range 1-10 days), and median time taken to return for normal activity was 5 days (range 2-50 days). One patient developed recurrence (2%). None of the patients who had laparoscopic repair completed complained of neuralgias in the follow-up. Conclusion Laparoscopic repair of inguinal hernias could be contemplated safely both via totally extra peritoneal as well as transperitoneal route even in our setup of a developing country with modifications. PMID:25170385

  6. Prospective longitudinal evaluation of a symptom cluster in breast cancer.

    PubMed

    Sanford, Stacy D; Beaumont, Jennifer L; Butt, Zeeshan; Sweet, Jerry J; Cella, David; Wagner, Lynne I

    2014-04-01

    Symptom cluster research expands cancer investigations beyond a focus on individual symptoms in isolation. We conducted a prospective longitudinal study of sleep, fatigue, depression, anxiety, and perceived cognitive impairment in patients with breast cancer undergoing chemotherapy. Patient-reported outcome measures were administered prior to chemotherapy, at Cycle 4 Day 1, and six months after initiating chemotherapy. Participants were divided into four groups and assigned a symptom cluster index (SCI) score based on the number/severity of symptoms reported at enrollment. Participants (N = 80) were mostly women (97.5%) with Stage II (69.0%) breast cancer, 29-71 years of age. Scores on all measures were moderately-highly correlated across all time points. There were time effects for all symptoms, except sleep quality (nonsignificant trend), with most symptoms worsening during chemotherapy, although anxiety improved. There were no significant group × time interactions; all four SCI groups showed a similar trajectory of symptoms over time. Worse performance status and quality of life were associated with higher SCI score over time. With the exception of anxiety, the coherence of the symptom cluster was supported by similar patterns of severity and change over time in these symptoms (trend for sleep quality). Participants with higher SCI scores prior to chemotherapy continued to experience greater symptom burden during and after chemotherapy. Early assessment and intervention addressing this symptom cluster (vs. individual symptoms) may have a greater impact on patient performance status and quality of life for patients with higher SCIs. Copyright © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  7. Efficacy and safety of Everolimus in children with TSC - associated epilepsy - Pilot data from an open single-center prospective study.

    PubMed

    Samueli, Sharon; Abraham, Klaus; Dressler, Anastasia; Gröppel, Gudrun; Mühlebner-Fahrngruber, Angelika; Scholl, Theresa; Kasprian, Gregor; Laccone, Franco; Feucht, Martha

    2016-11-03

    Epilepsy occurs in up to 90 % of all individuals with tuberous sclerosis complex (TSC). In 67 % disease onset is during childhood. In ≥ 50 % seizures are refractory to currently available treatment options. The mTOR-Inhibitor Everolimus (Votubia®) was approved for the treatment of subependymal giant cell astrocytoma (SEGA) and renal angiomyolipoma (AML) in Europe in 2011. It's anticonvulsive/antiepileptic properties are promising, but evidence is still limited. Study aim was to evaluate the efficacy and safety of Everolimus in children and adolescents with TSC-associated epilepsies. Inclusion-criteria of this investigator-initiated, single-center, open, prospective study were: 1) the ascertained diagnosis of TSC; 2) age ≤ 18 years; 3) treatment indication for Votubia® according to the European Commission guidelines; 4) drug-resistant TSC-associated epilepsy, 5) prospective continuous follow-up for at least 6 months after treatment initiation and 6) informed consent to participate. Votubia® was orally administered once/day, starting with 4.5 mg/m(2) and titrated to achieve blood trough concentrations between 5 and 15 ng/ml. Primary endpoint was the reduction in seizure frequency of ≥ 50 % compared to baseline. Fifteen patients (nine male) with a median age of six (range; 1-18) years fulfilled the inclusion criteria. 26 % (4/15) had TSC1, 66 % (10/15) had TSC2 mutations. In one patient no mutation was found. Time of observation after treatment initiation was median 22 (range; 6-50) months. At last observation, 80 % (12/15) of the patients were responders, 58 % of them (7/12) were seizure free. The overall reduction in seizure frequency was 60 % in focal seizures, 80 % in generalized tonic clonic seizures and 87 % in drop attacks. The effect of Everolimus was seen already at low doses, early after treatment initiation. Loss of efficacy over time was not observed. Transient side effects were seen in 93 % (14/15) of the patients. In no case the

  8. Evaluation of the conjoint efficacy in Chinese medicine with the longitudinal latent variable linear mixed model.

    PubMed

    Yi, Dan-Hui; Li, Yang; Shao, Shu-Xin; Xie, Yan-Ming; Yuwen, Ya

    2013-08-01

    Chinese medicine (CM) clinical efficacy evaluation research involves the longitudinal multivariate measurement which means that patients are measured repeatedly and each patient is measured by several indicators on each fixed cross-section. Although each indicator can be evaluated separately with a longitudinal linear mixed model, it is important to consider all the endpoints together especially when researchers pay special attention to the change of the conjoint efficacy for several indicators in one patient. In this article, we introduce a latent variable linear mixed model to the CM conjoint efficacy evaluation and discuss why and how to analyze the longitudinal multivariate endpoint data in the clinical CM efficacy evaluation research. It may lead to the new insight of using such methodology in the field of conjoint efficacy evaluating of CM study. And with the definition of syndrome and symptom in the CM theory, the applied discussion brings the insight of CM syndrome evaluating in future. We illustrate this methodology using an example of CM efficacy evaluation from an ischemic stroke research.

  9. Evaluation of calibration efficacy under different levels of uncertainty

    SciTech Connect

    Heo, Yeonsook; Graziano, Diane J.; Guzowski, Leah; Muehleisen, Ralph T.

    2014-06-10

    This study examines how calibration performs under different levels of uncertainty in model input data. It specifically assesses the efficacy of Bayesian calibration to enhance the reliability of EnergyPlus model predictions. A Bayesian approach can be used to update uncertain values of parameters, given measured energy-use data, and to quantify the associated uncertainty.We assess the efficacy of Bayesian calibration under a controlled virtual-reality setup, which enables rigorous validation of the accuracy of calibration results in terms of both calibrated parameter values and model predictions. Case studies demonstrate the performance of Bayesian calibration of base models developed from audit data with differing levels of detail in building design, usage, and operation.

  10. Evaluation of calibration efficacy under different levels of uncertainty

    DOE PAGES

    Heo, Yeonsook; Graziano, Diane J.; Guzowski, Leah; ...

    2014-06-10

    This study examines how calibration performs under different levels of uncertainty in model input data. It specifically assesses the efficacy of Bayesian calibration to enhance the reliability of EnergyPlus model predictions. A Bayesian approach can be used to update uncertain values of parameters, given measured energy-use data, and to quantify the associated uncertainty.We assess the efficacy of Bayesian calibration under a controlled virtual-reality setup, which enables rigorous validation of the accuracy of calibration results in terms of both calibrated parameter values and model predictions. Case studies demonstrate the performance of Bayesian calibration of base models developed from audit data withmore » differing levels of detail in building design, usage, and operation.« less

  11. Guidance for the Efficacy Evaluation of Products with Sporicidal Claims Against Clostridium difficile (June 2014)

    EPA Pesticide Factsheets

    This document provides an update to the Agency’s interim guidance for the efficacy evaluation of antimicrobial pesticides that are labeled for treating hard non-porous surfaces in healthcare settings contaminated with spores of Clostridium difficile.

  12. Dimethyl sulfoxide with lignocaine versus eutectic mixture of local anesthetics: prospective randomized study to compare the efficacy of cutaneous anesthesia in shock wave lithotripsy.

    PubMed

    Kumar, Santosh; Kumar, Sunil; Ganesamoni, Raguram; Mandal, Arup K; Prasad, Seema; Singh, Shrawan K

    2011-06-01

    The objective of the study was to compare the efficacy of dimethyl sulfoxide (DMSO) mixed with lignocaine and eutectic mixture of local anesthetics (EMLA) cream as topically applied surface anesthetics in relieving pain during shock wave lithotripsy (SWL) in a prospective randomized study. Of the 160 patients, 80 patients received DMSO with lignocaine and 80 patients received EMLA cream, applied to the skin of the flank at the area of entry of shock waves. SWL was done with Seimens lithostar multiline lithotripter. The pain during the procedure was assessed using visual analog and verbal rating scores. The mean visual analog scale scores for the two groups were 3.03 for DMSO group and 4.43 for EMLA group. The difference of pain score on visual analog scale was statistically significant (p < 0.05). Similarly, the pain scores as rated on the verbal rating scale were also evaluated; the mean score on verbal rating scale were 2.34 for DMSO group and 3.00 for the EMLA group. The difference between the pain score on verbal rating scale was also found to be statistically significant (p < 0.05). Our study showed that DMSO with lignocaine is a better local anesthetic agent for SWL than EMLA cream. The stone fragmentation and clearance rates are also better in the DMSO group.

  13. Efficacy and safety of autologous cultured melanocytes delivered on poly (DL-lactic acid) film: a prospective, open-label, randomized, multicenter study.

    PubMed

    Ghosh, Deepa; Kuchroo, Pushpa; Viswanathan, Chandra; Sachan, Shailendra; Shah, Bela; Bhatt, Deepa; Parasramani, Shrichand; Savant, Satish

    2012-12-01

    Small vitiliginous patches have been treated with epidermal grafts or their cell suspensions. In an attempt to overcome some of the shortcomings of cell suspension delivery, we have delivered melanocytes on a polymeric film. To evaluate the clinical effectiveness of a cultured graft consisting of autologous cultured melanocytes on a poly (DL-lactic acid) (PLA) film in subjects with stable vitiligo. A prospective open-label, randomized, multicenter clinical trial was conducted with 22 patients. Each subject was treated with cultured graft and polyurethane dressing (control arm) after epidermal ablation and followed for up to 9 months. The extent of repigmentation in the treated sites was compared with that control sites at days 90, 180, and 270. In the treatment arm, a minimum of 70% repigmentation was observed in five subjects at day 90; nine at day 180, and 10 at day 270. In the control arm, only one subject showed repigmentation until day 270. None of the test sites reported any recurrence of vitiliginous patches by the end of the study. Cultured melanocytes delivered on PLA film were efficacious and safe when applied on patients with stable vitiligo. © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

  14. Antianginal Efficacy and Tolerability of Ranolazine as an Add-on Drug to Concomitant Medications Primarily Metoprolol in Chronic Stable Angina Patients: A Prospective, Open-Label Study

    PubMed Central

    Khot, Anant Mahaveer; Anuradha, H. V.; Prakash, V. S.; Shivamurathy, M. C.

    2017-01-01

    Objective: To evaluate the efficacy and tolerability of ranolazine as an add-on drug in chronic stable angina patients and the impact of ranolazine on the quality of life in chronic stable angina patients receiving other antianginal medications. Materials and Methods: It was a prospective, open-label, hospital-based study involving 144 patients with chronic stable angina. First group received either metoprolol 12.5 or 25 mg/day or other antianginal medications; if the symptoms persist, the dose of metoprolol was increased to 50 mg/day, and to the second group, ranolazine 500 mg BD or 1 g OD was added along with metoprolol or others if the anginal attacks were not subsiding. The patients were followed up to 6 months with electrocardiography, treadmill test, and quality of life questionnaire. Adverse events were recorded at each visit during the study. Results: There was a statistically significant reduction in weekly anginal frequency (P < 0.001) and improvement in an exercise tolerance in both the groups, but more in the ranolazine group. Adverse events reported were mild, infrequent. Conclusion: Ranolazine is could be used as an add-on drug in chronic angina patients not improved with metoprolol or antianginal medications. PMID:28405132

  15. Efficacy of Traditional Chinese Medicine in Xerostomia and Quality of Life during Radiotherapy for Head and Neck Cancer: A Prospective Pilot Study

    PubMed Central

    Tsang, Ngan-Ming; Lin, Jr-Rung; Lin, Yung-Chang; Chen, Hsing-Yu; Yang, Ching-Wei

    2016-01-01

    Xerostomia is one of the most common acute and late complications of radiotherapy for head and neck cancer, and it affects quality of life. We conducted a prospective study to evaluate the efficacy of traditional Chinese medicine (TCM) in toxicities and quality of life during radiotherapy. Head and neck cancer patients who were scheduled for radiotherapy were checked for inclusion/exclusion criteria before enrollment. Patients in the study group (inpatients) were hospitalized in a Chinese medicine ward and received concomitant TCM intervention during radiotherapy, while those in the control group (outpatients) received only conventional cancer treatments at the Western outpatient department. The primary end point was amelioration of postradiotherapy side effects. The secondary end points were quality of life during the cancer therapy and occurrence of adverse events following the TCM treatments. Thirty inpatients and 50 outpatients completed the study. Compared to the control group, those in the TCM group had decreased severity of xerostomia. There was no treatment-related impairment of renal or hepatic function among TCM group. Although better outcomes of social contact, dyspnea, physical and emotional function, and financial problems were found in the TCM group, we need further confirmation about the impact of hospitalization itself on these results. PMID:27642359

  16. Prospective experience of percutaneous endoscopic gastrostomy tubes placed by otorhinolaryngologist-head and neck surgeons: safe and efficacious.

    PubMed

    Ruohoalho, Johanna; Aro, Katri; Mäkitie, Antti A; Atula, Timo; Haapaniemi, Aaro; Keski-Säntti, Harri; Kylänpää, Leena; Takala, Annika; Bäck, Leif J

    2017-09-01

    Percutaneous endoscopic gastrostomy (PEG) is often the treatment of choice in head and neck cancer (HNC) patients needing long-term nutritional support. Prospective studies on PEG tube placement in an otorhinolaryngologist service are lacking. At our hospital, otolaryngologist-head and neck (ORL-HN) surgeons-have performed PEG insertions for HNC patients since 2008. We prospectively analyzed 127 consecutive HNC patients who received their PEG tubes at the Department of Otorhinolaryngology-head and neck surgery, and evaluated the outcome of PEG tube insertions performed by ORL-HN surgeons. To compare time delays before and after, PEG placement service was transferred from gastrointestinal surgeons to ORL-HN surgeons, and we retrospectively analyzed a separate group of 110 HNC patients who had earlier received PEG tubes at the Department of Gastrointestinal Surgery. ORL-HN surgeons' success rate in PEG insertion was 97.6%, leading to a final prospective study group of 124 patients. Major complications occurred in four (3.2%): two buried bumper syndromes, one subcutaneous hemorrhage leading to an abscess in the abdominal wall, and one metastasis at the PEG site. The most common minor complication was peristomal granulomatous tissue affecting 23 (18.5%) patients. After the change in practice, median time delay before PEG insertion decreased from 13 to 10 days (P < 0.005). The proportion of early PEG placements within 0-3 days increased from 3.6 to 14.6% (P < 0.005). PEG tube insertion seems to be a safe procedure in the hands of an ORL-HN surgeon. Independence from gastrointestinal surgeons' services reduced the time delay and improved the availability of urgent PEG insertions.

  17. Prospective evaluation of early propranolol after traumatic brain injury.

    PubMed

    Murry, Jason S; Hoang, David M; Barmparas, Galinos; Harada, Megan Y; Bukur, Marko; Bloom, Matthew B; Inaba, Kenji; Margulies, Daniel R; Salim, Ali; Ley, Eric J

    2016-01-01

    Although beta-adrenergic receptor blockade may improve outcomes after traumatic brain injury (TBI), its early use is not routine. We hypothesize that judicious early low-dose propranolol after TBI (EPAT) will improve outcomes without altering bradycardia or hypotensive events. We conducted a prospective, observational study on all patients who presented with moderate-to-severe TBI from March 2010-August 2013. Ten initial patients did not receive propranolol (control). Subsequent patients received propranolol at 1-mg intravenous every 6 h starting within 12 h of intensive care unit (ICU) admission (EPAT) for a minimum of 48 h. Heart rate and blood pressure were recorded hourly for the first 72 h. Bradycardia and hypotensive events, mortality, and length of stay (LOS) were compared between cohorts to determine significant differences. Thirty-eight patients were enrolled; 10 control and 28 EPAT. The two cohorts were similar when compared by gender, emergency department (ED) systolic blood pressure, ED heart rate, and mortality. ED Glasgow coma scale was lower (4.2 versus 10.7, P < 0.01) and injury severity score higher in control. EPAT patients received a mean of 10 ± 14 doses of propranolol. Hypotensive events were similar between cohorts, whereas bradycardia events were higher in control (5.8 versus 1.6, P = 0.05). ICU LOS (15.4 versus 30.4 d, P = 0.02) and hospital LOS (10 versus 19.1 d, P = 0.05) were lower in EPAT. Mortality rates were similar between groups (10% versus 10.7%, P = 0.9). The administration of propranolol led to no recorded complications. Although bradycardia and hypotensive events occur early after TBI, low-dose intravenous propranolol does not increase their number or severity. Early use of propranolol after TBI appears to be safe and may be associated with decreased ICU and hospital LOS. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Usefulness of bowel sound auscultation: a prospective evaluation.

    PubMed

    Felder, Seth; Margel, David; Murrell, Zuri; Fleshner, Phillip

    2014-01-01

    Although the auscultation of bowel sounds is considered an essential component of an adequate physical examination, its clinical value remains largely unstudied and subjective. The aim of this study was to determine whether an accurate diagnosis of normal controls, mechanical small bowel obstruction (SBO), or postoperative ileus (POI) is possible based on bowel sound characteristics. Prospectively collected recordings of bowel sounds from patients with normal gastrointestinal motility, SBO diagnosed by computed tomography and confirmed at surgery, and POI diagnosed by clinical symptoms and a computed tomography without a transition point. Study clinicians were instructed to categorize the patient recording as normal, obstructed, ileus, or not sure. Using an electronic stethoscope, bowel sounds of healthy volunteers (n = 177), patients with SBO (n = 19), and patients with POI (n = 15) were recorded. A total of 10 recordings randomly selected from each category were replayed through speakers, with 15 of the recordings duplicated to surgical and internal medicine clinicians (n = 41) blinded to the clinical scenario. The sensitivity, positive predictive value, and intra-rater variability were determined based on the clinician's ability to properly categorize the bowel sound recording when blinded to additional clinical information. Secondary outcomes were the clinician's perceived level of expertise in interpreting bowel sounds. The overall sensitivity for normal, SBO, and POI recordings was 32%, 22%, and 22%, respectively. The positive predictive value of normal, SBO, and POI recordings was 23%, 28%, and 44%, respectively. Intra-rater reliability of duplicated recordings was 59%, 52%, and 53% for normal, SBO, and POI, respectively. No statistically significant differences were found between the surgical and internal medicine clinicians for sensitivity, positive predictive value, or intra-rater variability. Overall, 44% of clinicians reported that they rarely listened

  19. Regression Discontinuity in Prospective Evaluations: The Case of the FFVP Evaluation

    ERIC Educational Resources Information Center

    Klerman, Jacob Alex; Olsho, Lauren E. W.; Bartlett, Susan

    2015-01-01

    While regression discontinuity has usually been applied retrospectively to secondary data, it is even more attractive when applied prospectively. In a prospective design, data collection can be focused on cases near the discontinuity, thereby improving internal validity and substantially increasing precision. Furthermore, such prospective…

  20. Regression Discontinuity in Prospective Evaluations: The Case of the FFVP Evaluation

    ERIC Educational Resources Information Center

    Klerman, Jacob Alex; Olsho, Lauren E. W.; Bartlett, Susan

    2015-01-01

    While regression discontinuity has usually been applied retrospectively to secondary data, it is even more attractive when applied prospectively. In a prospective design, data collection can be focused on cases near the discontinuity, thereby improving internal validity and substantially increasing precision. Furthermore, such prospective…

  1. Efficacy of multimodal drug injection after supramalleolar osteotomy for varus ankle osteoarthritis: A prospective randomized study.

    PubMed

    Kim, Yong Sang; Kim, Bom Soo; Koh, Yong Gon; Lee, Jin Woo

    2016-05-01

    Optimal management of postoperative pain is important to ensure patient comfort and functional improvement. Despite the frequent use of multimodal drug injection for pain control after orthopedic surgery, few studies have evaluated its use after supramalleolar osteotomy. Supramalleolar osteotomy was performed in 62 patients (65 ankles). Thirty patients (31 ankles) were randomly assigned to receive multimodal drug injection (injection group) and 32 patients (34 ankles) were assigned to receive no multimodal drug injection (control group). The two groups were compared with regard to the degree of postoperative pain, the number of times patients pushed the patient-controlled analgesia (PCA) button, the total amount of fentanyl administered, and the frequency of additional diclofenac sodium injections. The injection group had significant pain reduction during the first 36 postoperative hours compared to the control group. There were significant differences between the groups in the number of times that patients pushed the PCA button as well as the total amount of fentanyl administered up to 24 h postoperatively. The mean frequency of additional diclofenac sodium injections in the first 12 postoperative hours was significantly less in the injection group compared to that in the control group. Multimodal drug injection was effective in reducing pain and decreasing both fentanyl and diclofenac sodium usage in patients undergoing supramalleolar osteotomy. Therefore, multimodal drug injection should be considered for improved pain control and patient comfort in the early postoperative period after supramalleolar osteotomy. Copyright © 2016 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

  2. Retrospective and prospective evaluation of the Carbapenem inactivation method for the detection of carbapenemase-producing Enterobacteriaceae

    PubMed Central

    Gauthier, Lauraine; Dortet, Laurent; Naas, Thierry

    2017-01-01

    Background There is an urgent need for accurate and rapid diagnostic tests to identify carbapenemase producing enterobacteria (CPE). Here, we have evaluated the Carbapenem Inactivation Method (CIM) test to detect CPEs from cultured colonies. Methods A total of 256 enterobacterial isolates were used to evaluate the performance of the CIM in comparison to Carba NP test and molecular detection used a reference method. Ninety three well-characterized isolates (including 29 non-CPE and 63 CPEs of worldwide origin) with decreased susceptibility to at least one carbapenem were used to (i) evaluate the efficacy of CIM test and (ii) to compare it to the Carba NP test. We also tested different carbapenems to determine the best substrate for this test. Finally, the CIM test was then evaluated prospectively against 164 isolates referred to the French National Reference Center (NRC) for Antimicrobial Resistance from may 2016 to july 2016. Results Based on the results of this retrospective study, sensitivity and specificity of the CIM and the Carba NP test were 92.1% and 100%, respectively. We demonstrated that the meropenem was the best substrate to perform the CIM test since sensitivity and specificity were 81.1% and 100% using ertapenem disk, and 100% and 65,6% using imipenem disk, and respectively. Taking in account the results of retrospective and prospective studies, CIM and Carba NP tests have similar sensitivity, specificity, positive predictive value and negative predictive values being 96.3%, 98.9%, 99.0% and 98.4% for the CIM test versus 96.9%, 100%, 100% and 100% for the Carba NP test. Conclusions Our results confirm that the CIM test may be a useful tool for the reliable confirmation of carbapenemase-activity in enterobacterial isolates, especially in clinical microbiological laboratories with limited resources, no trained personnel, and no specialized equipment. PMID:28158310

  3. A prospective observational study of the clinical efficacy and safety of intra-articular sodium hyaluronate in synovial joints with osteoarthritis.

    PubMed

    Foti, C; Cisari, C; Carda, S; Giordan, N; Rocco, A; Frizziero, A; Della Bella, G

    2011-09-01

    Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of synovial joints affected by osteoarthritis (OA), but data from observational studies of normal medical practice are sparse. This study investigated the safety and efficacy of intra-articular (IA) sodium hyaluronate (MW 1500-2000 KDa; Hyalubrix®) in the treatment of synovial joint OA. This is prospective, and observational study. This study was carried out at 47 specialist centers for physiatrists, orthopedics and rheumatology in Italy; the enrolled population, 1266 outpatient, was predominantly female (66%, 840/1266), with a mean age of 66 years, and a mean weight of 74 kg. The Participants with OA received IA injections of the study treatment (2 mL) once per week for 3 weeks. The knee was the joint most commonly affected by OA (right knee 802/1266 [63%]; left knee 598/1266 [47%]), and the longest median duration of disease occurred in the carpal joint (right carpal joint 40 months; left carpal joint 60 months). The primary endpoints were tolerability and details of usage of the IA sodium hyaluronate syringe device. Efficacy parameters included assessment of self-reported pain via the Visual Analogue Scale (VAS), and evaluation of motor function via the Health Assessment Questionnaire (HAQ). Quality of life (QoL) was assessed using the Euro QoL questionnaire (Clinical Trial Registration Number: ISRCTN 42690497). Data from 1266 participants were collected. The adverse event (AE) rate was 0.8% (95% CI, 0.4 to 1.5). Thirteen AEs were reported, 12 of which were mild or moderate in severity. Only one participant discontinued study treatment following an AE. No serious adverse events occurred. Coadministration of local anesthetic was required by up to 10% of patients. Statistically significant improvements in VAS, HAQ and EuroQoL were recorded in multiple joints (P<0.0001 for each). The study treatment was safe and well tolerated. . The study treatment

  4. Pre-Service Teachers' Retrospective and Prospective Evaluations: Program, Self, and Teaching Profession

    ERIC Educational Resources Information Center

    Ulusoy, Mustafa

    2015-01-01

    This study aimed to investigate teacher candidates' retrospective and prospective evaluations about the classroom teacher education program, self, and the teaching profession. Observations, interviews, focus group interviews, and surveys were used to collect data from the 240 subjects. Teacher candidates believed that the teaching profession is…

  5. Development of a Scale for Evaluating the Pedagogical Formation Program Implemented with Turkish Prospective Teachers

    ERIC Educational Resources Information Center

    Adiguzel, Oktay Cem

    2015-01-01

    The current study aims to develop a scale to evaluate the Pedagogical Formation Program implemented at a Turkish state university. Participants were 221 prospective teachers enrolled in the Pedagogical Formation Program in the 2010-2011 academic year. Exploratory factor analysis (EFA) was conducted on the scale items which revealed four factors…

  6. Development of a Questionnaire To Evaluate Fox Valley Technical College's Marketing Communications with Prospective Student Inquiries.

    ERIC Educational Resources Information Center

    May, Susan A.

    A questionnaire was developed to evaluate the effectiveness of Fox Valley Technical College's (FVTC's) marketing communications with prospective students. The literature on customer service, marketing communications, and institutional image was reviewed, and 17 construct criteria and 7 content criteria were developed as the framework for the…

  7. Development of a Scale for Evaluating the Pedagogical Formation Program Implemented with Turkish Prospective Teachers

    ERIC Educational Resources Information Center

    Adiguzel, Oktay Cem

    2015-01-01

    The current study aims to develop a scale to evaluate the Pedagogical Formation Program implemented at a Turkish state university. Participants were 221 prospective teachers enrolled in the Pedagogical Formation Program in the 2010-2011 academic year. Exploratory factor analysis (EFA) was conducted on the scale items which revealed four factors…

  8. Pre-Service Teachers' Retrospective and Prospective Evaluations: Program, Self, and Teaching Profession

    ERIC Educational Resources Information Center

    Ulusoy, Mustafa

    2015-01-01

    This study aimed to investigate teacher candidates' retrospective and prospective evaluations about the classroom teacher education program, self, and the teaching profession. Observations, interviews, focus group interviews, and surveys were used to collect data from the 240 subjects. Teacher candidates believed that the teaching profession is…

  9. The development and validation of the Self-Efficacy Beliefs about Equitable Science Teaching and learning instrument for prospective elementary teachers

    NASA Astrophysics Data System (ADS)

    Ritter, Jennifer M.

    1999-12-01

    The purpose of this study was to develop, validate and establish the reliability of an instrument to assess the self-efficacy beliefs of prospective elementary teachers with regards to science teaching and learning for diverse learners. The study used Bandura's theoretical framework, in that the instrument would use the self-efficacy construct to explore the beliefs of prospective elementary science teachers with regards to science teaching and learning to diverse learners: specifically the two dimensions of self-efficacy beliefs defined by Bandura (1977): personal self-efficacy and outcome expectancy. A seven step plan was designed and followed in the process of developing the instrument, which was titled the Self-Efficacy Beliefs about Equitable Science Teaching or SEBEST. Diverse learners as recognized by Science for All Americans (1989) are "those who in the past who have largely been bypassed in science and mathematics education: ethnic and language minorities and girls" (p. xviii). That definition was extended by this researcher to include children from low socioeconomic backgrounds based on the research by Gomez and Tabachnick (1992). The SEBEST was administered to 226 prospective elementary teachers at The Pennsylvania State University. Using the results from factor analyses, Coefficient Alpha, and Chi-Square a 34 item instrument was found to achieve the greatest balance across the construct validity, reliability and item balance with the content matrix. The 34 item SEBEST was found to load purely on four factors across the content matrix thus providing evidence construct validity. The Coefficient Alpha reliability for the 34 item SEBEST was .90 and .82 for the PSE sub-scale and .78 for the OE sub-scale. A Chi-Square test (X2 = 2.7 1, df = 7, p > .05) was used to confirm that the 34 items were balanced across the Personal Self-Efficacy/Outcome Expectancy and Ethnicity/LanguageMinority/Gender Socioeconomic Status/dimensions of the content matrix. Based on

  10. A prospective randomized comparison of defibrillation efficacy of truncated pulses and damped sine wave pulses in humans.

    PubMed

    Bardy, G H; Zaghi, H; Gartman, D; Poole, J E; Kudenchuk, P K; Dolack, G L; Johnson, G; Troutman, C

    1994-09-01

    Damped sine wave pulses have been used for nearly 50 years in transthoracic defibrillation systems. The purpose of this study was to determine whether damped sine wave pulses have a role in implantable defibrillators. In 21 survivors of cardiac arrest, we prospectively compared defibrillation efficacy of a standard truncated capacitor (RC) monophasic pulse with a damped sine wave inductor-capacitor (LRC) pulse using a right ventricular-left ventricular epicardial patch-patch electrode system. The RC pulse was a standard 65% tilt monophasic waveform generated from a 120 mu F capacitor. The LRC pulse was designed to simulate the waveform currently used in transthoracic defibrillators and was generated by passing the charge stored on a 40 mu F capacitor through a 37-mH inductor. Capacitor voltage, peak delivered voltage, peak delivered current, discharge pathway resistance, delivered energy, and stored energy were compared for the two waveforms at the defibrillation threshold. There was no difference in defibrillation efficacy for the two waveforms. Peak delivered voltage was similar at the defibrillation threshold: 313 +/- 101 V for the RC pulse and 342 +/- 119 V for the LRC pulse (P = 0.16). Similarly, no differences were found in defibrillation threshold peak delivered current: 8.6 +/- 2.5 (RC) versus 9.3 +/- 2.7 (LRC) amperes (A) (P = 0.20); discharge pathway resistance: 37 +/- 11 (RC) versus 38 +/- 13 (LRC) omega (P = 0.71); delivered energy: 7.0 +/- 4.5 (RC) versus 7.0 +/- 4.0 (LRC) joules (J) (P = 0.88); and stored energy: 8.7 +/- 5.7 (RC) versus 9.8 +/- 5.4 (LRC) J (P = 0.35). Although both waveforms performed the same, it was necessary to use substantially higher stored voltages with the damped sine wave delivery system than with the truncated waveform delivery system: 356 +/- 110 V for the RC pulse and 675 +/- 192 V for the LRC pulse (P < 0.0001). This study demonstrates that RC monophasic pulses provide equally effective epicardial defibrillation as LRC

  11. Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI)

    PubMed Central

    2013-01-01

    Background Acute exacerbations of chronic bronchitis (AECB), including chronic obstructive pulmonary disease (AECOPD), represent a substantial patient burden. Few data exist on outpatient antibiotic management for AECB/AECOPD in Eastern/South Eastern Europe, in particular on the use of moxifloxacin (Avelox®), although moxifloxacin is widely approved in this region based on evidence from international clinical studies. Methods AVANTI (AVelox® in Acute Exacerbations of chroNic bronchiTIs) was a prospective, observational study conducted in eight Eastern European countries in patients > 35 years with AECB/AECOPD to whom moxifloxacin was prescribed. In addition to safety and efficacy outcomes, data on risk factors and the impact of exacerbation on daily life were collected. Results In the efficacy population (N = 2536), chronic bronchitis had been prevalent for > 10 years in 31.4% of patients and 66.0% of patients had concomitant COPD. Almost half the patients had never smoked, in contrast to data from Western Europe and the USA, where only one-quarter of COPD patients are non-smokers. The mean number of exacerbations in the last 12 months was 2.7 and 26.3% of patients had been hospitalized at least once for exacerbation. Physician compliance with the recommended moxifloxacin dose (400 mg once daily) was 99.6%. The mean duration of moxifloxacin therapy for the current exacerbation (Anthonisen type I or II in 83.1%; predominantly type I) was 6.4 ± 1.9 days. Symptom improvement was reported after a mean of 3.4 ± 1.4 days. After 5 days, 93.2% of patients reported improvement and, in total, 93.5% of patients were symptom-free after 10 days. In the safety population (N = 2672), 57 (2.3%) patients had treatment-emergent adverse events (TEAEs) and 4 (0.15%) had serious TEAEs; no deaths occurred. These results are in line with the known safety profile of moxifloxacin. Conclusions A significant number of patients in this observational study had risk

  12. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial

    PubMed Central

    Levkovitz, Yechiel; Isserles, Moshe; Padberg, Frank; Lisanby, Sarah H; Bystritsky, Alexander; Xia, Guohua; Tendler, Aron; Daskalakis, Zafiris J; Winston, Jaron L; Dannon, Pinhas; Hafez, Hisham M; Reti, Irving M; Morales, Oscar G; Schlaepfer, Thomas E; Hollander, Eric; Berman, Joshua A; Husain, Mustafa M; Sofer, Uzi; Stein, Ahava; Adler, Shmulik; Deutsch, Lisa; Deutsch, Frederic; Roth, Yiftach; George, Mark S; Zangen, Abraham

    2015-01-01

    Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas. This is the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. We recruited 212 MDD outpatients, aged 22–68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode. They were randomly assigned to monotherapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively. dTMS induced a 6.39 point improvement in HDRS-21 scores, while a 3.28 point improvement was observed in the sham group (p+0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p+0.013; remission: 32.6 vs. 14.6%, p+0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred. These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment. PMID:25655160

  13. Efficacy of direct arthroscopy-guided suprascapular nerve block after arthroscopic rotator cuff repair: a prospective randomized study.

    PubMed

    Lee, Jae Jun; Yoo, Yon-Sik; Hwang, Jung-Taek; Kim, Do-Young; Jeon, Seong-Jae; Hwang, Sung Mi; Jang, Ji Su

    2015-02-01

    The purpose of this study was to evaluate the outcomes of arthroscopy-guided direct suprascapular nerve block performed after arthroscopic rotator cuff repair. In the present prospective, randomized, double-blinded clinical study, 30 patients were divided into two groups: 15 patients (group I) were treated with arthroscopy-guided suprascapular nerve block using 10 mL 0.5 % ropivacaine with 1:200,000 epinephrine, and 15 patients (group II) were treated with placebo using 10 mL 0.9 % saline after arthroscopic rotator cuff repair. Patient pain levels were measured using the visual analog scale (VAS) at 1, 3, 6, 12, 18, and 24 h post-operatively. Additionally, the number of boluses and total amount of fentanyl dispensed by patient-controlled analgesia administration during the 24-h post-operative period were evaluated. VAS scores did not differ significantly between groups I and II during the 24-h post-operative period, but mean fentanyl bolus consumption was significantly less in group I compared with group II (p = 0.015). Arthroscopy-guided suprascapular nerve block at the end of a rotator cuff repair was safe and less time-consuming than expected. Although this procedure did not significantly reduce the post-operative pain, the post-operative need for fentanyl boluses as analgesia was reduced significantly, and it would be beneficial if this procedure involved a sensory branch of axillary nerve block or was performed at the beginning of the arthroscopic procedure. Prospective, randomized, double-blinded clinical trial, Level I.

  14. Evaluation of in vitro efficacy of the disinfectant Virkon.

    PubMed

    Gasparini, R; Pozzi, T; Magnelli, R; Fatighenti, D; Giotti, E; Poliseno, G; Pratelli, M; Severini, R; Bonanni, P; De Feo, L

    1995-04-01

    A study was conducted on a new acid peroxygen system based disinfectant (Virkon), in order to assess its in vitro efficacy. The chemical was tested on different bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli), spores (Bacillus subtilis) and on the Hepatitis B surface antigen (HBsAg), and compared in its activity with phenol and glutaraldehyde (calculation of the 'phenol coefficient' and the 'glutaraldehyde coefficient'). The constancy of speed of disinfection, the coefficient of concentration, the minimal inhibitory concentration (MIC) were also determined, and the destruction of the HBsAg antigenic activity was studied using an ELISA kit. The sporicidal efficacy of Virkon was assessed by cultivating spores in agar nutrient after contact with different dilutions of the disinfectant. The results of the tests showed that Virkon has a high concentration coefficient (mean value of k: 0.374/min) and a wide range of action. The low MIC demonstrates how little concentrations of Virkon can inactivate all studied bacteria. The disinfectant was also able to destroy the hepatitis B surface antigen, and it demonstrated good activity against spores, especially if used in physiologic solution. These characteristics, coupled with the absence of initiation or toxic effects on animals showed by other studies, make wide fields of application for the new disinfectant foreseeable.

  15. Efficacy of intra-articular hyaluronic acid in patients with osteoarthritis of the ankle: a prospective study.

    PubMed

    Sun, Shu-Fen; Chou, Yi-Jiun; Hsu, Chien-Wei; Hwang, Chiao-Wen; Hsu, Pei-Te; Wang, Jue-Long; Hsu, Ya-Wen; Chou, Mei-Chia

    2006-09-01

    To investigate the efficacy, safety and the duration of treatment effectiveness of intra-articular hyaluronic acid (Artz, Japan) in patients with ankle osteoarthritis (OA). As a prospective clinical trial, 93 patients with unilateral ankle pain for at least 6 months and radiographically classified as Kellgren-Lawrence grade I or II ankle OA were included. After five weekly intra-articular Artz injections, the Ankle Osteoarthritis Scale (AOS), the American Orthopaedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, ankle sagittal range of motion (ROM), patients' global satisfaction, local adverse events and consumption of rescue analgesics were analyzed. Seventy-five patients completed the study. Significant improvement in AOS and AOFAS ankle/hindfoot scores was noted at 1 week, 1 month, 3 months and 6 months post the fifth injection (P < 0.001 compared with baseline). The mean reduction of AOS score was 1.9, 2.6, 2.5 and 2.6 at each following visit (P < 0.001). The mean AOFAS ankle/hindfoot score improved from 64 points at baseline to 75, 78, 78, and 78 points at 1 week, 1 month, 3 months and 6 months, respectively, post the fifth injection (P < 0.001). Ankle sagittal ROM did not improve significantly (P > 0.05). The majority of patients reported satisfaction at 1 week (100%), 1 month (100%), 3 months (90.7%) and 6 months (86.7%) follow-up. Local adverse events occurred in 6.7% of patients. Acetaminophen consumption dropped significantly following treatment (P < 0.001). Five weekly intra-articular injections of Artz provide pain relief and functional improvements in patients with Kellgren-Lawrence grades I and II ankle OA. The clinical effect was rapid at 1 week and may last for 6 months or more.

  16. The Efficacy of Amicar Versus Tranexamic Acid in Pediatric Spinal Deformity Surgery: A Prospective, Randomized, Double-Blinded Pilot Study.

    PubMed

    Halanski, Matthew A; Cassidy, Jeffrey A; Hetzel, Scott; Reischmann, Diann; Hassan, Nabil

    2014-05-01

    Single-center, prospective, randomized, double-blinded trial. To compare blood loss, allogenic transfusion requirements, and coagulation parameters between pediatric spinal deformity patients receiving aminocaproic acid (Amicar) or tranexamic acid (TXA) during posterior spinal fusion. Amicar and TXA have been shown to decrease blood loss in pediatric spinal deformity cases compared with controls. The difference in efficacy between these medications in this population has not been reported. Enrolled patients were randomized to receive either Amicar or TXA during scoliosis surgery. Baseline demographic and deformity comparisons were collected. Intraoperative comparisons included estimated and calculated blood loss, number of levels instrumented, number of osteotomies, operative time, and allogenic transfusion requirements. Preoperative and postoperative hemoglobin, platelets, prothrombin time, partial prothrombin time (PTT), international normalized ratio (INR), and fibrinogen were recorded. A total of 47 patients were enrolled with data available for review (N = 25, Amicar; N = 22, TXA). No difference in cohorts was found in demographics, preoperative hemoglobin, platelets, prothrombin time, PTT, INR, initial Cobb angle, average number of: levels fused, patients with osteotomies and osteotomies, operative time, and final Cobb angles. Estimated blood loss was significantly less (about 221 mL) than the calculated blood loss in both groups (p = .003). Estimated blood loss (1,088 vs. 726 mL; p = .055) and calculated blood loss (1,366 vs. 903 mL; p = .13) trended higher in the Amicar group. Although no difference in allogenic transfusion rates (20% vs. 14%) was observed, average volumes transfused were significantly higher in the Amicar cohort (1,014 vs. 461 mL; p = .03). The TXA cohort demonstrated a statistically significant smaller change in INR, a lower PTT, and greater fibrinogen levels postoperatively. Compared with Amicar, TXA use was associated with a lower

  17. Efficacy of Fascial Distortion Model Treatment for Acute, Nonspecific Low-Back Pain in Primary Care: A Prospective Controlled Trial.

    PubMed

    Richter, Detlef; Karst, Matthias; Buhck, Hartmut; Fink, Matthias G

    2017-06-23

    Context • Low-back pain (LBP) is a prevalent and potentially crippling condition for which treatment is often unsatisfactory from the perspectives of physicians, patients, and payers. The application of the fascial distortion model (FDM), an integrated concept for the diagnosis and manipulative treatment of musculoskeletal disorders, is conceptually promising for LBP but has not been investigated systematically. Objective • The study intended to provide proof of concept to establish the noninferiority of the FDM treatment as opposed to the therapy recommended by the German National Disease Management Guideline (NDMG) for acute LBP. Design • The study was a prospective, nonrandomized, controlled, parallel-group trial. Setting • The study took place in a private practice for surgery and orthopedics. Participants • Seventy-seven outpatients with acute LBP with an average age of 42.6 ± 13.5 y, 50.6% of whom were male, took part in the study. Intervention • Participants in the intervention group (FDM group) received osteopathic manipulative treatments according to the FDM, whereas the control group (NDMG group) received an active control treatment following the NDMG. Outcome Measures • Comparing the FDM group (n = 39) and the NDMG group (n = 38), the study measured pain (visual analog scale, patient diary), functional (FFbH-R) and self-reported vocational status, and use of medication (patient diary) at baseline and after 1, 4 and 12 wk of treatment. Results • The study found marked improvements of the symptoms in both groups, with a faster onset of efficacy and significantly less medication under the FDM treatment. Conclusions • FDM appears to be effective with regard to pain relief and functional improvement for LBP.

  18. Evaluation of development prospects of renewable energy: agent based modelling

    NASA Astrophysics Data System (ADS)

    Klevakina, E. A.; Zabelina, I. A.; Murtazina, M. Sh

    2017-01-01

    The paper describes the agent-based model usage to evaluate the dynamics and the perspectives of alternative energy adopting in the Eastern regions of Russia. It includes a brief review of the agent-based models that can be used for estimation of alternatives in the process of transition to “green” economics. The authors show that active usage of solar energy in Russia is possible at the rural household level, when the climate conditions are appropriate. Adoption of solar energy sources decreases the energy production based on the conventional sources and improves the quality of environment in the regions. A complex regional multi-agent model is considered in this paper. The model consists of several private models and uses GIS technologies. These private models are a demographic and migration model of the region and a diffusion of the innovations model. In these models, agents are humans who live within the boundaries of the agents-municipalities, and agents as well are large-scale producers of electricity that pollutes the environment. Such a structure allows us to determine the changes in the demand for electricity generated by traditional sources. A simulation software will assist to identify the opportunities for implementation of alternative energy sources in the Eastern regions of Russia.

  19. Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses☆

    PubMed Central

    Pinto-Fraga, José; Blázquez Arauzo, Francisco; Urbano Rodríguez, Rubén; González-García, María J.

    2014-01-01

    Purpose To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. Methods This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Results Twenty subjects (10 women, 10 men) (mean age, 27.7 ± 5.6 years; range, 20–41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p = 0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p = 0.18). The study MPDS received higher rates in comfort (study: 8.14 ± 1.09, control: 7.94 ± 0.92; p = 0.56) and satisfaction at day 30 (study: 8.63 ± 0.91, control: 8.29 ± 0.80; p = 0.19), however the scores were not significantly different with the control MPDS. Conclusions The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation. PMID:25649640

  20. Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

    PubMed

    Pinto-Fraga, José; Blázquez Arauzo, Francisco; Urbano Rodríguez, Rubén; González-García, María J

    2015-01-01

    To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Twenty subjects (10 women, 10 men) (mean age, 27.7±5.6 years; range, 20-41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p=0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p=0.18). The study MPDS received higher rates in comfort (study: 8.14±1.09, control: 7.94±0.92; p=0.56) and satisfaction at day 30 (study: 8.63±0.91, control: 8.29±0.80; p=0.19), however the scores were not significantly different with the control MPDS. The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation. Copyright © 2014 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

  1. Prospective Evaluation of Thoracic Ultrasound in the Detection of Pneumothorax

    NASA Technical Reports Server (NTRS)

    Schwarz, K. W.; Hamilton, D. R.; Kirkpatrick, A. W.; Billica, R. D.; Williams, D. R.; Diebel, L. N.; Sargysan, A. E.; Dulchavsky, S. A.

    2000-01-01

    Introduction: Pneumothorax (PTX) occurs commonly in trauma patients and is confirmed by examination and radiography. Thoracic ultrasound (VIS) has been suggested as an alternative method for rapidly diagnosing PTX when X-ray is unavailable as in rural, military, or space flight settings; however, its accuracy and specificity are not known. Methods: We evaluated the accuracy of thoracic U/S detection of PTX compared to radiography in stable, emergency patients with a high suspicion of PTX at a Level-l trauma center over a 6-month period. Following University and NASA Institutional Review Board approval, informed consent was obtained from patients with penetrating or blunt chest trauma, or with a history consistent with PTX. Whenever possible, the presence or absence of the " lung sliding" sign or the "comet tail" artifact were determined by U/S in both hemithoraces by residents instructed in thoracic U/S before standard radiologic verification of PTX. Results were recorded on data sheets for comparison to standard radiography. Results: Thoracic VIS had a 94% sensitivity; two PTX could not be reliably diagnosed due to subcutaneous air; the true negative rate was 100%. In one patient, the VIS exam was positive while X ray did not confirm PTX; a follow-up film 1 hour later demonstrated a small PTX. The average time for bilateral thoracic VIS examination was 2 to 3 minutes. Conclusions: Thoracic ultrasound reliably diagnoses pneumothorax. Presence of the "lung sliding" sign conclusively excludes pneumothorax. Expansion of the FAST examination to include the thorax should be investigated.

  2. Critical evaluation of the efficacy and tolerability of azilsartan

    PubMed Central

    De Caterina, Alberto R; Harper, Andrew R; Cuculi, Florim

    2012-01-01

    Appropriate control of blood pressure (BP) in hypertensive patients still represents the major therapeutic goal in the treatment of hypertension. Despite the growing attention and wide range of antihypertensive agents available in the clinical scenario, the target of BP below the advised thresholds of 140/90 mmHg is, unfortunately, often unreached. For this reason, the search for new antihypertensive agents is still ongoing. Azilsartan medoxomil, a new angiotensin receptor blocker that has been recently introduced in the clinical arena, represents the eighth angiotensin receptor blocker currently available for BP control. The aim of this paper is to describe the efficacy and safety profile of this new compound, reviewing available data obtained from both pre-clinical and clinical studies. PMID:22661897

  3. Critical evaluation of the efficacy and tolerability of azilsartan.

    PubMed

    De Caterina, Alberto R; Harper, Andrew R; Cuculi, Florim

    2012-01-01

    Appropriate control of blood pressure (BP) in hypertensive patients still represents the major therapeutic goal in the treatment of hypertension. Despite the growing attention and wide range of antihypertensive agents available in the clinical scenario, the target of BP below the advised thresholds of 140/90 mmHg is, unfortunately, often unreached. For this reason, the search for new antihypertensive agents is still ongoing. Azilsartan medoxomil, a new angiotensin receptor blocker that has been recently introduced in the clinical arena, represents the eighth angiotensin receptor blocker currently available for BP control. The aim of this paper is to describe the efficacy and safety profile of this new compound, reviewing available data obtained from both pre-clinical and clinical studies.

  4. Distributed and accumulated reinforcement arrangements: evaluations of efficacy and preference.

    PubMed

    DeLeon, Iser G; Chase, Julie A; Frank-Crawford, Michelle A; Carreau-Webster, Abbey B; Triggs, Mandy M; Bullock, Christopher E; Jennett, Heather K

    2014-01-01

    We assessed the efficacy of, and preference for, accumulated access to reinforcers, which allows uninterrupted engagement with the reinforcers but imposes an inherent delay required to first complete the task. Experiment 1 compared rates of task completion in 4 individuals who had been diagnosed with intellectual disabilities when reinforcement was distributed (i.e., 30-s access to the reinforcer delivered immediately after each response) and accumulated (i.e., 5-min access to the reinforcer after completion of multiple consecutive responses). Accumulated reinforcement produced response rates that equaled or exceeded rates during distributed reinforcement for 3 participants. Experiment 2 used a concurrent-chains schedule to examine preferences for each arrangement. All participants preferred delayed, accumulated access when the reinforcer was an activity. Three participants also preferred accumulated access to edible reinforcers. The collective results suggest that, despite the inherent delay, accumulated reinforcement is just as effective and is often preferred by learners over distributed reinforcement.

  5. DISTRIBUTED AND ACCUMULATED REINFORCEMENT ARRANGEMENTS: EVALUATIONS OF EFFICACY AND PREFERENCE

    PubMed Central

    DELEON, ISER G.; CHASE, JULIE A.; FRANK-CRAWFORD, MICHELLE A.; CARREAU-WEBSTER, ABBEY B.; TRIGGS, MANDY M.; BULLOCK, CHRISTOPHER E.; JENNETT, HEATHER K.

    2015-01-01

    We assessed the efficacy of, and preference for, accumulated access to reinforcers, which allows uninterrupted engagement with the reinforcers but imposes an inherent delay required to first complete the task. Experiment 1 compared rates of task completion in 4 individuals who had been diagnosed with intellectual disabilities when reinforcement was distributed (i.e., 30-s access to the reinforcer delivered immediately after each response) and accumulated (i.e., 5-min access to the reinforcer after completion of multiple consecutive responses). Accumulated reinforcement produced response rates that equaled or exceeded rates during distributed reinforcement for 3 participants. Experiment 2 used a concurrent-chains schedule to examine preferences for each arrangement. All participants preferred delayed, accumulated access when the reinforcer was an activity. Three participants also preferred accumulated access to edible reinforcers. The collective results suggest that, despite the inherent delay, accumulated reinforcement is just as effective and is often preferred by learners over distributed reinforcement. PMID:24782203

  6. Prospective Randomized Controlled Study on the Efficacy of Multimedia Informed Consent for Patients Scheduled to Undergo Green-Light High-Performance System Photoselective Vaporization of the Prostate

    PubMed Central

    Ham, Dong Yeub; Choi, Woo Suk; Song, Sang Hoon; Ahn, Young-Joon; Park, Hyoung Keun; Kim, Hyeong Gon

    2016-01-01

    Purpose The aim of this study was to evaluate the efficacy of a multimedia informed consent (IC) presentation on the understanding and satisfaction of patients who were scheduled to receive 120-W green-light high-performance system photoselective vaporization of the prostate (HPS-PVP). Materials and Methods A multimedia IC (M-IC) presentation for HPS-PVP was developed. Forty men with benign prostatic hyperplasia who were scheduled to undergo HPS-PVP were prospectively randomized to a conventional written IC group (W-IC group, n=20) or the M-IC group (n=20). The allocated IC was obtained by one certified urologist, followed by a 15-question test (maximum score, 15) to evaluate objective understanding, and questionnaires on subjective understanding (range, 0~10) and satisfaction (range, 0~10) using a visual analogue scale. Results Demographic characteristics, including age and the highest level of education, did not significantly differ between the two groups. No significant differences were found in scores reflecting the objective understanding of HPS-PVP (9.9±2.3 vs. 10.6±2.8, p=0.332) or in subjective understanding scores (7.5±2.1 vs. 8.6±1.7, p=0.122); however, the M-IC group showed higher satisfaction scores than the W-IC group (7.4±1.7 vs. 8.4±1.5, p=0.033). After adjusting for age and educational level, the M-IC group still had significantly higher satisfaction scores. Conclusions M-IC did not enhance the objective knowledge of patients regarding this surgical procedure. However, it improved the satisfaction of patients with the IC process itself. PMID:27169129

  7. Efficacy of the Revised NIOSH Lifting Equation to Predict Risk of Low-Back Pain Associated With Manual Lifting: A One-Year Prospective Study

    PubMed Central

    Lu, Ming-Lun; Waters, Thomas R.; Krieg, Edward; Werren, Dwight

    2015-01-01

    Objective The objective was to evaluate the efficacy of the Revised National Institute for Occupational Safety and Health (NIOSH) lifting equation (RNLE) to predict risk of low-back pain (LBP). Background In 1993, NIOSH published the RNLE as a risk assessment method for LBP associated with manual lifting. To date, there has been little research evaluating the RNLE as a predictor of the risk of LBP using a prospective design. Methods A total of 78 healthy industrial workers' baseline LBP risk exposures and self-reported LBP at one-year follow-up were investigated. The composite lifting index (CLI), the outcome measure of the RNLE for analyzing multiple lifting tasks, was used as the main risk predictor. The risk was estimated using the mean and maximum CLI variables at baseline and self-reported LBP during the follow-up. Odds ratios (ORs) were calculated using a logistic regression analysis adjusted for covariates that included personal factors, physical activities outside of work, job factors, and work-related psychosocial characteristics. Results The one-year self-reported LBP incidence was 32.1%. After controlling for history of prior LBP, supervisory support, and job strain, the categorical mean and maximum CLI above 2 had a significant relationship (OR = 5.1–6.5) with self-reported LBP, as compared with the CLI below or equal to 1. The correlation between the continuous CLI variables and LBP was unclear. Conclusions The CLI > 2 threshold may be useful for predicting self-reported LBP. Research with a larger sample size is needed to clarify the exposure–response relationship between the CLI and LBP. PMID:24669544

  8. [The efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women: a randomized, prospective, multicenter study].

    PubMed

    Rafal'skiĭ, V V; Dovgan', E V; Kozyrev, Iu V; Gustovarova, T A; Khlybova, S V; Novoselova, A V; Filippenko, N G; Likhikh, D G

    2013-01-01

    The study was aimed to the evaluation of efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women. A prospective, multicenter, randomized study that included 112 pregnant women with asymptomatic bacteriuria was performed. 58 women were randomized in group 1 (cefixime [suprax solutab] 400 mg 1 time a day, 7 days), 54 women were included in group 2 (amoxicillin/clavulanate [amoksiklav] 625 mg 3 times a day, 7 days). The average age of the patients in group 1 was 25.2 +/- 6.6; in group 2--26.6 +/- 5.8 years. Physical examination, evaluation of complaints, collection of data on adverse reactions, and bacteriological analysis of urine were performed after enrollment in the study at visit 2 (day 10 +/- 1) and 3 (day 35 +/- 2). Comparable effectiveness of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women was found. Eradication of the pathogen and sustained bacteriological response were observed in 94.8 and 92.7% of women treated with cefixime, and in 98.2 and 92.5% of women treated with amoxicillin/clavulanate, respectively (P > 0.05). At the same time, the use of amoxicillin/clavulanate compared with cefixime significantly higher was followed by the development of adverse reactions (13% and 1.7; respectively; P = 0.02). Seven-day courses of cefixime at a dose 400 mg 1 time a day and amoxicillin/clavulanate at a dose of 625 mg 3 times a day are high-effective treatment regimens for asymptomatic bacteriuria in pregnant women in Russia. The use of amoxicillin/clavulanate is significantly more often accompanied by the development of adverse reactions compared with cefixime.

  9. Efficacy of a checklist as part of a physical medicine and rehabilitation clerkship to teach medical students musculoskeletal physical examination skills: a prospective study.

    PubMed

    Altschuler, Eric L; Cruz, Eduardo; Salim, Sara Z; Jani, Jay B; Stitik, Todd P; Foye, Patrick M; DeLisa, Joel A

    2014-01-01

    The aim of this study was to evaluate the efficacy of a checklist as part of a physical medicine clerkship to teach medical students physical examination maneuvers. This is a prospective study performed on fourth year medical students enrolled in a 2-wk mandatory clerkship of the Department of Physical Medicine and Rehabilitation. At the start and end of the rotation, the participating students were tested by performing 20 physical examination maneuvers on an investigator who was both the standardized patient and the evaluator. At the end of the rotation, the students also completed a survey. Data were analyzed using the Bernoulli trial model, with the percentage of students who performed the maneuver correctly on the pretest as the a priori probability. A full Bonferroni correction was applied. The authors enrolled 141 of the 176 fourth year medical students; 121 completed testing. At prerotation, approximately 35% of the physical examination maneuvers were performed correctly; at postrotation, 82%. For 19 of 20 maneuvers, the improvement was statistically significant at P < 0.01. The survey results indicated that the students felt that they had limited exposure to musculoskeletal examination skills at prerotation, that this rotation helped them achieve competency in performing the maneuvers, and that this would improve their future patient care irrespective of field of choice. Considering the high prevalence of musculoskeletal disorders and the anticipated rise in the future, the authors strongly recommend teaching musculoskeletal physical examination maneuvers in medical school, which can be accomplished via a mandatory physical medicine and rehabilitation rotation. The authors conclude that checklists as part of this rotation can effectively help in teaching physical examination skills to medical students.

  10. Efficacy and safety of early tacrolimus conversion to sirolimus after kidney transplantation: Long-term results of a prospective randomized study

    PubMed Central

    El-Agroudy, A. E.; Alarrayed, S. M.; Al-Ghareeb, S. M.; Farid, E.; Alhelow, H.; Abdulla, S.

    2017-01-01

    We report a prospective, open-label, randomized study to evaluate the safety and efficacy of converting patients with a stable renal function from tacrolimus (Tac)-based regimen to a sirolimus (SRL)-based regimen after kidney transplantation. Fifty-eight low-risk renal allograft recipients who receiving Tac 6 months posttransplant, were randomly assigned to continue Tac (n = 29) or convert to SRL (n = 29). We evaluated the 3-year outcomes including patient and graft survival, graft function, and safety profile. Three-year patient and graft survival in SRL and Tac groups were 93.1% versus 100% (P = 0.32), and 89.7% versus 100% (P = 0.11), respectively. However, the SRL group had a significantly better renal function, from the 2nd year posttransplant until the last follow-up. Four (13.8%) patients in the SRL group and 3 (10.3%) in the Tac group (P = 0.5) developed biopsy-proven acute rejection. Mean urinary protein excretion increased significantly after SRL conversion. Diastolic blood pressure was significantly lower at the end of the study in patients who eliminated Tac (80.4 vs. 75.6 mmHg in Tac and SRL group, respectively) (P = 0.03). Mean hemoglobin concentrations decreased after SRL conversion and remained significantly lower from 12 months to 36 months (P = 0.01). The mean serum cholesterol (540 ± 44 mg/dl) and triglyceride (177 ± 27 mg/dl) increased significantly in the SRL group, compared to Tac group (487 ± 62 mg/dl) (P = 0.03) and (141 ± 26 mg/dl) (P = 0.04). Our experience demonstrates that conversion to SRL from calcineurin inhibitors-based therapy may result in better renal function and blood pressure control in renal transplant recipients without an increased risk of acute rejection. However, these benefits have not resulted in a growing advantage in graft or patient survival. PMID:28182044

  11. Prospective diagnostic performance evaluation of single-voxel 1H MRS for typing and grading of brain tumours.

    PubMed

    Julià-Sapé, Margarida; Coronel, Indira; Majós, Carles; Candiota, Ana Paula; Serrallonga, Marta; Cos, Mònica; Aguilera, Carles; Acebes, Juan José; Griffiths, John R; Arús, Carles

    2012-04-01

    The purpose of this study was to evaluate whether single-voxel (1)H MRS could add useful information to conventional MRI in the preoperative characterisation of the type and grade of brain tumours. MRI and MRS examinations from a prospective cohort of 40 consecutive patients were analysed double blind by radiologists and spectroscopists before the histological diagnosis was known. The spectroscopists had only the MR spectra, whereas the radiologists had both the MR images and basic clinical details (age, sex and presenting symptoms). Then, the radiologists and spectroscopists exchanged their predictions and re-evaluated their initial opinions, taking into account the new evidence. Spectroscopists used four different systems of analysis for (1)H MRS data, and the efficacy of each of these methods was also evaluated. Information extracted from (1)H MRS significantly improved the radiologists' MRI-based characterisation of grade IV tumours (glioblastomas, metastases, medulloblastomas and lymphomas) in the cohort [area under the curve (AUC) in the MRI re-evaluation 0.93 versus AUC in the MRI evaluation 0.85], and also of the less malignant glial tumours (AUC in the MRI re-evaluation 0.93 versus AUC in the MRI evaluation 0.81). One of the MRS analysis systems used, the INTERPRET (International Network for Pattern Recognition of Tumours Using Magnetic Resonance) decision support system, outperformed the others, as well as being better than the MRI evaluation for the characterisation of grade III astrocytomas. Thus, preoperative MRS data improve the radiologists' performance in diagnosing grade IV tumours and, for those of grade II-III, MRS data help them to recognise the glial lineage. Even in cases in which their diagnoses were not improved, the provision of MRS data to the radiologists had no negative influence on their predictions.

  12. Efficacy and durability of hyaluronic acid fillers for malar enhancement: a prospective, randomized, spilt-face clinical controlled trial.

    PubMed

    Jeong, Ki Heon; Gwak, Min Jae; Moon, Sung Kyung; Lee, Sang Jun; Shin, Min Kyung

    2017-01-31

    Various hyaluronic acid fillers can be used for facial attenuation and rejuvenation. The efficacy and durability of hyaluronic acid fillers are of major concern to dermatologists and patients. This study aimed to evaluate three dimensional morphology, tissue distribution, and changes in volume after injection of two different hyaluronic acid fillers. Ten Korean women were enrolled in this study. Each subject was injected with monophasic hyaluronic acid filler in one malar area and biphasic filler in the other. Clinical outcome was measured before and after injection, and after 2, 4, 6, 8, 12, and 24 weeks, using the Global Aesthetic Improvement Scale, photographs and Moire's topography. Facial magnetic resonance imaging (MRI) was performed twice over six months. Both products showed good results after injection and demonstrated good durability over time. MRI was a useful modality for assessing tissue distribution and volume changes. The effects and durability after injection of monophasic hyaluronic acid filler and biphasic hyaluronic acid filler are generally comparable.

  13. A 10-year prospective-longitudinal study of daily hassles and incident psychopathology among adolescents and young adults: interactions with gender, perceived coping efficacy, and negative life events.

    PubMed

    Asselmann, Eva; Wittchen, Hans-Ulrich; Lieb, Roselind; Beesdo-Baum, Katja

    2017-09-09

    To prospectively examine whether higher daily hassles predict a variety of incident mental disorders and respective associations vary by gender, age, perceived coping efficacy and number of negative life events. Data comes from the Early Developmental Stages of Psychopathology Study (EDSP), a prospective-longitudinal study among adolescents and young adults from the community (n = 2797, aged 14-24 at baseline) followed up in up to 3 assessment waves over 10 years. Mental disorders were assessed at each wave using the DSM-IV/M-CIDI. Daily hassles, perceived coping efficacy, and negative life events were assessed at baseline using the Daily Hassles Scale, Scale for Self-Control and Coping Skills, and Munich Life Event List. In logistic regressions adjusted for gender, age, other mental disorders, perceived coping efficacy and number of negative life events at baseline, higher daily hassles at baseline predicted the incidence of any anxiety disorder, specific phobia, obsessive-compulsive disorder, any affective disorder, and major depressive episodes at follow-up (OR 1.2-1.9 per standard deviation). Daily hassles interacted with perceived coping efficacy at baseline in predicting incident panic attacks (OR 1.3) and panic disorder (OR 1.3) at follow-up, i.e., higher daily hassles only predicted incident panic pathology among individuals with low perceived coping efficacy (OR 1.6-2.0) but not high perceived coping efficacy. Moreover, the associations between daily hassles and incident mental disorders partially varied by gender and age but not by negative life events at baseline. Targeted stress management interventions among individuals with increased daily hassles might be useful to prevent the onset of anxiety and affective disorders.

  14. Safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery: prospective and multicentric trial.

    PubMed

    Nasser, Felipe; Kambara, Antonio; Abath, Carlos; Cavalcanti, Douglas; Barros, Ilana; Pires, Norma; Rivera, Marco; Neser, Adnan; Ingrund, Jose; Burihan, Marcelo; Silveira, Pierre; Galego, Gilberto; Bortoluzzi, Cristiano; Franklin, Rafael; Bosiers, Marc; Deloose, Koen; Razuk, Alvaro; Caffaro, Roberto; Karakhanian, Walter K; Park, Jong; Lopes, Caetano; Pinto, Daniel; Bez, Leonardo; Lopes, Rodrigo; Mourão, André; Kleinsorge, Gustavo

    2017-06-01

    The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA). From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months. Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major

  15. A prospective, randomized pilot study on the safety and efficacy of recombinant human growth and differentiation factor-5 coated onto β-tricalcium phosphate for sinus lift augmentation.

    PubMed

    Koch, Felix P; Becker, Jürgen; Terheyden, Hendrik; Capsius, Björn; Wagner, Wilfried

    2010-11-01

    The aim of this prospective, randomized clinical trial was to investigate the potential of recombinant human growth and differentiation factor-5 (rhGDF-5) coated onto β-tricalcium phosphate (β-TCP) (rhGDF-5/β-TCP) to support bone formation after sinus lift augmentation. In total, 31 patients participated in this multicenter clinical trial. They required a two-stage unilateral maxillary sinus floor augmentation (residual bone height <5 mm). According to a parallel-group design, the patients were randomized to three treatment groups: (a) augmentation with rhGDF-5/β-TCP and a 3-month healing period, (b) augmentation with rhGDF-5/β-TCP and a 4-month healing period and (c) medical device β-TCP mixed with autologous bone and a 4-month healing period. The primary study objective was the area of newly formed bone within the augmented area as assessed by histomorphometric evaluation of trephine bur biopsies. The osseous regeneration was similar in each treatment group; the amount of newly formed bone ranged between 28% (± 15.5%) and 31.8% (± 17.9%). Detailed analysis of histological data will be published elsewhere. As secondary efficacy variables, the augmentation height at the surgery site was measured by radiography. The largest augmentation was radiologically achieved in the rhGDF-5/β-TCP - 3-month and the rhGDF-5/β-TCP - 4-month treatment groups. As safety parameters, adverse events were recorded and anti-drug antibody levels were evaluated. Most of the adverse events were judged as unrelated to the study medication. Four out of 47 (8.5%) implants failed in patients treated with rhGDF-5/β-TCP, a result that is in agreement with the general implant failure rate of 5-15%. Transiently very low amounts of anti-rhGDF-5 antibodies were detected in some patients who received rhGDF-5, which was not related to the bone formation outcome. rhGDF-5/β-TCP was found to be effective and safe as the control treatment with autologous bone mixed β-TCP in sinus floor

  16. Prospective evaluation of immediate and delayed provisional single tooth restorations.

    PubMed

    Block, Michael S; Mercante, Donald E; Lirette, Denise; Mohamed, Waheed; Ryser, Mark; Castellon, Paulino

    2009-11-01

    The purpose of this study was 2-fold: to determine whether there is a significant difference in the hard and soft tissue response comparing immediate with delayed implant placement after tooth removal, with immediate provisionalization, in maxillary anterior sites; and to determine and compare the crestal bone levels as the primary endpoint variable for implants placed and immediately temporized in extraction sites, to implants placed into extraction sites after the extraction site has been grafted and healed for 4 months, all immediately restored with an anatomic provisional restoration. This aim was to be evaluated by measuring crestal bone levels on standardized digital radiographs of the implants, using implant threads as a monitor of magnification and a pre-extraction reference. Secondary endpoint variables include soft tissue measures compared with method. A total of 76 patients were recruited and randomized into treatment groups. Group 1 had a maxillary tooth (premolar, canine, lateral or central incisor) removed, with immediate socket grafting, followed by implant placement and provisionalization 4 months later with a single tooth. Group 2 had immediate implant placement and provisionalization. Standardized radiograph holders were used to expose digital radiographs every 6 months from baseline to up to 2 years restored. Soft tissue measures were made from standardized reference points. Data collected were analyzed by a statistician to test the hypotheses. A total of 55 patients completed their follow-up. Twenty-one patients were lost to follow-up because of implant loss (n = 5), 1 treated out of protocol because of labial bone loss found at the time of tooth removal (n = 1), geographic relocation (n = 11), dropped for noncompliance (n = 3), or medical problems (n = 1). The analyses showed no significant differences between groups in implant integration or crestal interdental bone movement on either the implant or the adjacent tooth. The bone level on the

  17. Safety and efficacy of a novel intravascular cooling device to control body temperature in neurologic intensive care patients: a prospective pilot study.

    PubMed

    Schmutzhard, Erich; Engelhardt, Klaus; Beer, Ronny; Brössner, Gregor; Pfausler, Bettina; Spiss, Heinz; Unterberger, Iris; Kampfl, Andreas

    2002-11-01

    To determine the safety and efficacy of a novel intravascular cooling device (Cool Line catheter with Cool Gard system) to control body temperature (temperature goal <37 degrees C) in neurologic intensive care patients. A prospective, uncontrolled pilot study in 51 consecutive neurologic intensive care patients. A neurologic intensive care unit at a tertiary care university hospital. Patients were 51 neurologic intensive care patients with an intracranial disease requiring a central venous catheter due to the primary (intracranial) disease. We excluded patients under the age of 19 yrs and those with active cardiac arrhythmia, full sepsis syndrome, bleeding diathesis and infection, or bleeding at the site of the intended catheter insertion. Male to female ratio was 31:20, and the median age was 55 yrs (range, 24-85 yrs). Forty-four of 51 patients (86.3%) had an initial Glasgow Coma Scale score of 3, three patients had a Glasgow Coma Scale score of 9, one patient presented with an initial Glasgow Coma Scale score of 11, two patients had an initial Glasgow Coma Scale score of 13, and one patient had an initial Glasgow Coma Scale score of 15. The mean initial tissue injury severity score was 45.1 and the median initial tissue injury severity score 45.0 (range, 19-70). Patients were enrolled prospectively in a consecutive way. Within 12 hrs after admission, the intravascular cooling device (Cool Line catheter) was placed, the temperature probe was located within the bladder (by Foley catheter), and the Cool Gard cooling device was initiated. This Cool Gard system circulates temperature-controlled sterile saline through two small balloons mounted on the distal end of the Cool Line catheter. The patient's blood is gently cooled as it is passed over the balloons. The Cool Gard system has been set with a target temperature of 36.5 degrees C. The primary purpose and end point of this study was to evaluate the cooling capacity of this intravascular cooling device. Efficacy is

  18. Measuring Practicing and Prospective Elementary Teachers' Efficacy for Classroom Management: A Preliminary Development and Validation Study

    ERIC Educational Resources Information Center

    Putman, S. Michael

    2013-01-01

    Research has shown efficacy exerts a powerful influence on behavior. Classroom management represents one vehicle for demonstrations of these behaviors, yet few instruments focus solely on the measurement of this domain-specific form of efficacy. This research explored the relationship between teacher self-efficacy and classroom management through…

  19. Measuring Practicing and Prospective Elementary Teachers' Efficacy for Classroom Management: A Preliminary Development and Validation Study

    ERIC Educational Resources Information Center

    Putman, S. Michael

    2013-01-01

    Research has shown efficacy exerts a powerful influence on behavior. Classroom management represents one vehicle for demonstrations of these behaviors, yet few instruments focus solely on the measurement of this domain-specific form of efficacy. This research explored the relationship between teacher self-efficacy and classroom management through…

  20. Improving decision making in multidisciplinary tumor boards: prospective longitudinal evaluation of a multicomponent intervention for 1,421 patients.

    PubMed

    Lamb, Benjamin W; Green, James S A; Benn, Jonathan; Brown, Katrina F; Vincent, Charles A; Sevdalis, Nick

    2013-09-01

    Due to its complexity, cancer care is increasingly being delivered by multidisciplinary tumor boards (MTBs). Few studies have investigated how best to organize and run MTBs to optimize clinical decision making. We developed and evaluated a multicomponent intervention designed to improve the MTB's ability to reach treatment decisions. We conducted a prospective longitudinal study during 16 months that evaluated MTB decision making for urological cancer patients at a university hospital in London, UK. After a baseline period, MTB improvement interventions (eg, MTBs checklist, MTB team training, and written guidance) were delivered sequentially. Outcomes measures were the MTB's ability to reach a decision, the quality of information presentation, and the quality of teamwork (as assessed by trained assessors using a previously validated observational assessment tool). The efficacy of the intervention was evaluated using multivariate analyses. There were 1,421 patients studied between December 2009 and April 2, 2011. All outcomes improved considerably between baseline and intervention implementation: the MTB's ability to reach a decision rose from 82.2% to 92.7%, quality of information presentation rose from 29.6% to 38.3%, and quality of teamwork rose from 37.8% to 43.0%. The MTB's ability to reach a treatment decision was related to the quality of available information (r = 0.298; p < 0.05) and quality of teamwork within the MTB (r = 0.348; p < 0.05). The most common barriers to reaching clinical decisions were inadequate radiologic information (n = 77), inadequate pathologic information (n = 51), and inappropriate patient referrals (n = 21). Multidisciplinary tumor board-delivered treatment is becoming the standard for cancer care worldwide. Our intervention is efficacious and applicable to MTBs and can improve decision making and expedite cancer care. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  1. Template for developing guidelines for the evaluation of the clinical efficacy of psychophysiological interventions.

    PubMed

    2002-12-01

    An essential function of both the Association for Applied Psychophysiology and Biofeedback (AAPB) and the Society for Neuronal Regulation (SNR) is the systematic evaluation of psychophysiological interventions that have been developed for the treatment of medical and psychiatric disorders. In order to address scientific concerns regarding the efficacy of specific clinical applications of biofeedback, these two societies formed and Efficacy Task Force. The process to be used in the assessment of treatment efficacy, specificity and clinical utility is presented in the form of a template that will serve as the foundation for a series of scientific reviews and practice guidlines to be published by both societies.

  2. Motivation for Evaluation: A roadmap for Improving Program Efficacy

    NASA Astrophysics Data System (ADS)

    Taber, J. J.; Bohon, W.; Bravo, T. K.; Dorr, P. M.; Hubenthal, M.; Johnson, J. A.; Sumy, D. F.; Welti, R.; Davis, H. B.

    2016-12-01

    Over the past year, the Incorporated Research Institutions for Seismology (IRIS) Education and Public Outreach (EPO) program has undertaken a new effort to increase the rigor with which it evaluates its programs and products. More specifically we sought to make evaluation an integral part of our EPO staff's work, enable staff to demonstrate why we do the activities we do, enhance the impact or our products and programs, and empower staff to be able to make evidence-based claims. The challenges we faced included a modest budget, finding an applicable approach to both new and legacy programs ranging from formal and informal education to public outreach, and implementing the process without overwhelming staff. The Collaborative Impact Analysis Method (IAM; Davis and Scalice, 2015) was selected as it allowed us to combine the EPO staff's knowledge of programs, audiences and content with the expertise of an outside evaluation expert, through consultations and a qualitative rubric assessing the initial state of each product/program's evaluation. Staff then developed action plans to make incremental improvements to the evaluation of programs over time. We have found that this approach promotes the development of staff knowledge and skills regarding evaluation, provides a common language among staff, increases enthusiasm to collect and share data, encourages discussions of evaluative approaches when planning new activities, and improves each program's ability to capture the intended and unintended effects on the behaviors, attitudes, skills, interests, and/or knowledge of users/participants. We will share the initial IAM Scores for products and programs in the EPO portfolio, along with examples of the action plans for several key products and programs, and the impact that implementing those actions plans has had on our evaluations. Davis, H. & Scalice, D. (2015). Evaluate the Impact of your Education and Outreach Program Using the Quantitative Collaborative Impact Analysis

  3. Evaluation of the clinical efficacy of prokinetic drugs in the management of post-operative ileus: can retrospective data help us?

    PubMed

    Smith, M A; Edwards, G B; Dallap, B L; Cripps, P J; Proudman, C J

    2005-09-01

    The objectives of the study were to determine whether retrospective data can be used to answer questions about the efficacy of prokinetic agents when used to treat horses with post-operative ileus (POI). We describe prevalence and mortality of POI with reference to treatment with four prokinetic agents. By combining data from two Hospitals a study population of 55 horses with POI following pedunculated lipoma obstruction (PLO) was established. Univariable and multivariable associations were determined between short term survival and potential explanatory variables. With death as outcome in multivariable models, breed and hospital were significantly associated with outcome but the use of prokinetic agents was not (P=0.15). However, sample size estimates indicate the low power of this study to detect differences in outcome. It was not possible definitively to evaluate the efficacy of prokinetics as treatment for POI following PLO using retrospective data. The data were suggestive of limited efficacy of prokinetics as treatment for POI. It is postulated that the identified association between hospital and survival reflects differences in clinician decision making. The study highlights the need for further prospective studies using randomised clinical trials to evaluate accurately the efficacy of prokinetic agents. This report illustrates difficulties with performing retrospective analysis of clinical data to determine the efficacy of treatment regimes.

  4. Healthcare professionals' attitudes, knowledge and self-efficacy levels regarding the use of self-hypnosis in childbirth: A prospective questionnaire survey.

    PubMed

    McAllister, Sophie; Coxon, Kirstie; Murrells, T; Sandall, J

    2017-04-01

    to examine healthcare professionals' attitudes, knowledge and levels of self-efficacy regarding the use of self-hypnosis in childbirth. a prospective survey. two large maternity units in London, England. healthcare professionals (n=129) involved in the care of childbearing women (anaesthetists, midwives and obstetricians). online questionnaire assessing healthcare professionals' experience, knowledge, attitudes and self-efficacy relating to self-hypnosis in childbirth. attitude, self-efficacy and knowledge. over half of the participants surveyed (56%) reported they had minimal or no knowledge of hypnosis. Higher levels of knowledge were associated with higher levels of self-efficacy (p<0.001) and also with more positive attitudes (p<.001). Midwives reported significantly higher levels of knowledge, more positive attitudes (7.25, 95% CI: 4.60-9.89) and higher levels of self-efficacy (3.48, 95% CI: 1.46-5.51) than doctors. Midwives also reported more exposure to/experience of hypnosis than doctors, and more exposure was significantly associated with higher levels of self-efficacy (midwives p<.001; doctors p=.001). Professionals who would plan to use self-hypnosis in their own or partners' births had significantly higher self-efficacy scores (p<.001). if healthcare professionals are to effectively support women using self-hypnosis in childbirth, they need to be confident in their ability to facilitate this method. Previous research has established that self-efficacy is a strong indicator of performance. Professionals with more knowledge of self-hypnosis are also more confident in supporting women using this technique in childbirth. Multi-disciplinary staff training which aims to increase knowledge, and which includes exposure to hypnosis in labour, may be beneficial in assisting staff to support women choosing to use self-hypnosis in labour. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Nubac Disc Arthroplasty: Preclinical Studies and Preliminary Safety and Efficacy Evaluations

    PubMed Central

    Songer, Matthew; Pimenta, Luis; Werner, Dieter; Reyes-Sanchez, Alejandro; Balsano, Massimo; Agrillo, Umberto; Coric, Domagoj; Davenport, Kenneth; Yuan, Hansen

    2007-01-01

    Background Disc arthroplasty is gaining popularity for treatment of low-back pain caused by degenerative disc disease (DDD). It can involve total disc replacement or partial disc or nucleus replacement (or augmentation). Compared with total disc replacement, nucleus replacement is less invasive, has less surgical risk, has faster postoperative recovery, and doesn't “burn bridges” should further surgery be required. However, nucleus replacement has a high risk of implant expulsion because the device is not fixed to the vertebrae. Nubac is the first polyetheretherketone (PEEK)-on-PEEK articulated disc arthroplasty device designed to optimally restore the lumbar anatomy and biomechanics. Methods ISO 10993 standards were used to evaluate the biocompatibility of the PEEK material. Chemical and thermal–mechanical tests and in vivo study assessed PEEK's biostability after exposure to high g irradiation and harsh oxidative conditions. Biomechanical tests to evaluate kinematic properties and anatomical restoration of the implanted lumbar motion segments and implant expulsion risk assessments were performed with a human cadaveric model. Because of the novelty of PEEK-on-PEEK as a self-mating articulating material, extensive wear tests were conducted with unidirectional and coupled motions. Static and fatigue strength also were tested. Animal study with a baboon model was conducted with gross, radiographic, biomechanical, and histological evaluations at 6 and 12 months postoperatively. Preliminary clinical data were collected through a prospective multicenter cohort study. Results PEEK demonstrated exceptional biocompatibility and biodurability. Nubac restored disc height and motion segment range of motion. The unique articulating design of the Nubac demonstrated low risk of implant expulsion in a human cadaveric model. Wear tests showed that the Nubac has minimal wear and compares favorably to other disc arthroplasty materials. The Nubac also had excellent static and

  6. Evaluating the Efficacy of the Cloud for Cluster Computation

    NASA Technical Reports Server (NTRS)

    Knight, David; Shams, Khawaja; Chang, George; Soderstrom, Tom

    2012-01-01

    Computing requirements vary by industry, and it follows that NASA and other research organizations have computing demands that fall outside the mainstream. While cloud computing made rapid inroads for tasks such as powering web applications, performance issues on highly distributed tasks hindered early adoption for scientific computation. One venture to address this problem is Nebula, NASA's homegrown cloud project tasked with delivering science-quality cloud computing resources. However, another industry development is Amazon's high-performance computing (HPC) instances on Elastic Cloud Compute (EC2) that promises improved performance for cluster computation. This paper presents results from a series of benchmarks run on Amazon EC2 and discusses the efficacy of current commercial cloud technology for running scientific applications across a cluster. In particular, a 240-core cluster of cloud instances achieved 2 TFLOPS on High-Performance Linpack (HPL) at 70% of theoretical computational performance. The cluster's local network also demonstrated sub-100 ?s inter-process latency with sustained inter-node throughput in excess of 8 Gbps. Beyond HPL, a real-world Hadoop image processing task from NASA's Lunar Mapping and Modeling Project (LMMP) was run on a 29 instance cluster to process lunar and Martian surface images with sizes on the order of tens of gigapixels. These results demonstrate that while not a rival of dedicated supercomputing clusters, commercial cloud technology is now a feasible option for moderately demanding scientific workloads.

  7. Evaluating the Efficacy of the Cloud for Cluster Computation

    NASA Technical Reports Server (NTRS)

    Knight, David; Shams, Khawaja; Chang, George; Soderstrom, Tom

    2012-01-01

    Computing requirements vary by industry, and it follows that NASA and other research organizations have computing demands that fall outside the mainstream. While cloud computing made rapid inroads for tasks such as powering web applications, performance issues on highly distributed tasks hindered early adoption for scientific computation. One venture to address this problem is Nebula, NASA's homegrown cloud project tasked with delivering science-quality cloud computing resources. However, another industry development is Amazon's high-performance computing (HPC) instances on Elastic Cloud Compute (EC2) that promises improved performance for cluster computation. This paper presents results from a series of benchmarks run on Amazon EC2 and discusses the efficacy of current commercial cloud technology for running scientific applications across a cluster. In particular, a 240-core cluster of cloud instances achieved 2 TFLOPS on High-Performance Linpack (HPL) at 70% of theoretical computational performance. The cluster's local network also demonstrated sub-100 ?s inter-process latency with sustained inter-node throughput in excess of 8 Gbps. Beyond HPL, a real-world Hadoop image processing task from NASA's Lunar Mapping and Modeling Project (LMMP) was run on a 29 instance cluster to process lunar and Martian surface images with sizes on the order of tens of gigapixels. These results demonstrate that while not a rival of dedicated supercomputing clusters, commercial cloud technology is now a feasible option for moderately demanding scientific workloads.

  8. Acupuncture for crack-cocaine detoxification: experimental evaluation of efficacy.

    PubMed

    Lipton, D S; Brewington, V; Smith, M

    1994-01-01

    Anecdotal studies have reported acupuncture alleviating the severity of withdrawal symptoms associated with cocaine abuse. The efficacy of auricular (ear) acupuncture in reducing cocaine/crack craving and consumption was examined via a single-blind, placebo experiment. One hundred and fifty individuals seeking treatment for cocaine/crack abuse were randomly assigned to receive either experimental or placebo acupuncture treatments. Treatments were provided in an outpatient setting for a one-month period. Placebo treatments involved acupuncture at ear locations not used for drug treatment. Subjects provided urine specimens for drug content analysis after each acupuncture session. Urinalysis results over the one-month study period favored the experimental group. Experimental subjects in treatment over 2 weeks had significantly lower cocaine metabolite levels relative to placebo subjects in treatment for a comparable period. Treatment retention with both groups was similar. Relative to pretreatment usage, a significant decrease in cocaine consumption was reported by both groups. Self-report outcomes did not indicate significant between-groups differences.

  9. Cryoablation of renal angiomyolipoma - an evaluation of safety and efficacy.

    PubMed

    Makki, Ahmad; Graumann, Ole; Hoyer, Soren; Solvig, Jan; Oestraat, Oeyvind; Madsen, Mia Gebauer; Nielsen, Tommy Kjærgaard

    2017-08-22

    Small series have reported that cryoablation (CA) is a safe and feasible minimally invasive nephron-sparing alternative for the treatment of renal angiomyolipomas (renal AML). The aim of the present study was to investigate the safety and efficacy of CA in patients with renal AML. A retrospective review of 19 renal AML lesions treated with CA at Aarhus University Hospital, Denmark, over a five-year period. The treatment was performed as laparoscopic-assisted CA on 7 lesions and in the remaining 12 lesions CA was performed as a percutaneous ultrasound guided CA. The mean patient age was 46 years (IQR 30) and the mean tumor volume was 50.1 cm3 (IQR 53.3). In all cases the procedure was successfully conducted with no conversion to open surgery and no major complications were experienced. The mean follow-up time was 25 months (IQR 13). Mean maximum tumor volume was reduced from 50.1 cm3 (IQR 53.3) to 12.2 cm3 (IQR 14.1), p=0.05. No patients presented with retroperitoneal hemorrhage or recurrence during follow-up. Conclusion Treating renal AMLs with cryoablation appears to be a safe and effective nephron-sparing approach and could be a valuable alternative to other treatment modalities. The low complication rate, absence of retreatment and a good preservation of renal function might allow treatment of even subclinical renal AMLs to minimize the risk of potentially life-threatening hemorrhage.

  10. Re-evaluation of ivermectin efficacy against equine gastrointestinal parasites.

    PubMed

    Klei, T R; Rehbein, S; Visser, M; Langholff, W K; Chapman, M R; French, D D; Hanson, P

    2001-07-27

    Two trials were conducted to confirm the efficacy of ivermectin paste against endoparasites of horses. In these trials, 20 ponies were treated with ivermectin oral paste at 200 mcg x kg body weight once on Day 0, and 20 ponies served as unmedicated controls. The animals carried naturally acquired parasite infections as confirmed by pretrial fecal examination. The animals were necropsied for worm recovery on Days 14, 15 or 16. Parasites recovered were identified to species. Horses treated with ivermectin had significantly (P<0.05) fewer (>99.0% reduction) adult small strongyles (Coronocyclus spp including C. coronatus, C. labiatus, C. labratus; Cyathostomum spp including C. catinatum, C. pateratum; Cylicocyclus spp including C. ashworthi, C. elongatus, C. insigne, C. leptostomum, C. nassatus, C. radiatus; Cylicodontophorus bicoronatus; Cylicostephanus spp including C. asymetricus, C. bidentatus, C. calicatus, C. goldi, C. longibursatus, C. minutus; Gyalocephalus capitatus; Parapoteriostomum spp including P. euproctus, P. mettami; Petrovinema poculatum; Poteriostomum spp including P. imparidentatum, P. ratzii) and adult large strongyles (Strongylus edentatus, S. vulgaris; Triodontophorus spp including T. brevicauda, T. serratus; Craterostomum acuticaudatum) than the controls. Ivermectin was also highly effective (94% to >99%, P<0.05-0.01) against Gasterophilus intestinalis larvae, Habronema spp., Oxyuris equi, Parascaris equorum. The data from these two trials confirm that ivermectin paste administered to horses orally at 200mcg x kg(-1) continues to be highly effective for treatment and control of a broad range of small and large strongyle species as well as other species of gastrointestinal parasites.

  11. [Comparative evaluation of the antihypertensive efficacy of amlodipine versus enalapril].

    PubMed

    Alicajić, Fredi

    2009-01-01

    Goal of this study was to compare the efficacy and safety of amlodipine with enalaprile in case of patients with moderate essential arterial hypertension. Study involved 40 patients with hypertension, 22 males and 18 females, age 39-80 years. Diastolic blood pressure was from 100-120 mmHg. Patients were for two weeks without any therapy and after that were divided into two groups of 20, fortherapy with amlodipine or enalaprile. The patients received 5-10 mg of amlodipine or enalaprile once daily. Initial blood pressure, before therapy was similar in groups, 173.00/108.00 mmHg and 175.25/106.75 mmHg (mean value). After four weeks on treatment the BP was reduced in both groups, in group on amlodipine from 173.00/108.00 to 129.75/78.50 mmHg (mean value), and in the group on enalaprile from 175.25/106.75 to 133.50/81.50 mmHg. Patients did not report any side effects in either of the groups. We prove that one day therapy with small doses, 5-10 mg of amlodipine, new calcium channels blocker and enalaprile, ACE inhibitor were efficient and safe in therapy of the essential hypertension. We found that amlodipine was somewhat more efficient than enalaprile in lowering the blood pressure.

  12. Evaluation of adjuvant effects of fucoidan for improving vaccine efficacy.

    PubMed

    Kim, Su-Yeon; Joo, Hong-Gu

    2015-01-01

    Fucoidan is a sulfated polysaccharide derived from brown seaweed, including Fucus vesiculosus. This compound is known to have immunostimulatory effects on various types of immune cells including macrophages and dendritic cells. A recent study described the application of fucoidan as a vaccine adjuvant. Vaccination is regarded as the most efficient prophylactic method for preventing harmful or epidemic diseases. To increase vaccine efficacy, effective adjuvants are needed. In the present study, we determined whether fucoidan can function as an adjuvant using vaccine antigens. Flow cytometric analysis revealed that fucoidan increases the expression of the activation markers major histocompatibility complex class II, cluster of differentiation (CD)25, and CD69 in spleen cells. In combination with Bordetella bronchiseptica antigen, fucoidan increased the viability and tumor necrosis factor-α production of spleen cells. Furthermore, fucoidan increased the in vivo production of antigen-specific antibodies in mice inoculated with Mycoplasma hyopneumoniae antigen. Overall, this study has provided valuable information about the use of fucoidan as a vaccine adjuvant.

  13. Comparative clinical efficacy evaluation of three gingival displacement systems

    PubMed Central

    Shrivastava, Kirti Jajoo; Bhoyar, Anjali; Agarwal, Surendra; Shrivastava, Saurabh; Parlani, Swapnil; Murthy, Varsha

    2015-01-01

    Aim: We compared the clinical efficacy of three gingival displacement systems to accurately record intra-crevicular margins of tooth preparation. Materials and Methods: One mechanical (magic foam cord) and two chemico-mechanical (expasyl paste and retraction cord impregnated with 15% aluminum chloride) gingival displacement systems were used. This study was conducted on the maxillary central incisors of 20 patients (20-60 years old) requiring full coverage restoration. All the three gingival displacement systems were tested in three sessions at an interval of 14 days in same order. The casts were sectioned and viewed under an optical microscope, followed by quantitative measurements of the width of the pre and postretracted sulci. Results: All the three displacement systems produced highly significant horizontal gingival displacement. Retraction cord soaked in 15% aluminum chloride produced maximum displacement (0.74 mm), followed by expasyl paste (0.48 mm) whereas magic foam cord produced the least displacement (0.41 mm). Conclusions: Gingival displacement shown by each displacement system was found to be more than the accepted value necessary for elastomeric impression accuracy (0.2 mm) to record intra-crevicular margins of tooth preparation. PMID:26604620

  14. Psychometric properties of the self-efficacy for clinical evaluation scale in Turkish nursing students.

    PubMed

    Zengin, Neriman; Pınar, Rukiye; Akinci, Ayse Cil; Yildiz, Hicran

    2014-04-01

    To examine psychometric properties of the Self-Efficacy for Clinical Evaluation Scale (SECS) in a nursing student sample. Self-efficacy is a good choice to be used in order to make a prediction of nursing students' performance in clinical practice. The SECS, consisting of perceived self-efficacy and importance subscales, seems to be suitable to evaluate self-efficacy regarding care skills for patients with chronic diseases. However, there is not a valid tool to evaluate the perception of self-efficacy for Turkish nursing students. Cross-sectional methodological design. The sample included 400 Turkish nursing students who attended practicum at a hospital. Content of the SECS was evaluated by content validity index (CVI). Reliability was evaluated with internal consistency, item-total correlation and test-retest reliability. Confirmatory factor analysis (CFA) and convergent and divergent validity were used to test the validity. The CVI results were satisfactory. We found satisfactory evidence for internal consistency and item-total correlations. Intraclass correlation coefficients showed stability of subscales. The CFA replicated two-factor structure for the SECS. This was reflected in all fit indices. All factor loadings were positive and were above the perfect level. The convergent validity was supported by the correlation between SECS and General Self-Efficacy Scale. The divergent validity findings demonstrated that SECS differentiated between students with various levels of general point average, which is an indicator of academic success. In conclusion, SECS is a reliable and valid tool used in clinical nursing education settings. Measuring students' self-efficacy in a clinical environment can provide an insight for students into what they have learned. Nurse educators can also use the SECS to spot nursing students with weaknesses in care activities and create educational strategies to help them to enhance their academic performance. Using the SECS can yield an

  15. Evaluating the efficacy of a new flossing aid.

    PubMed

    Spolsky, V W; Perry, D A; Meng, Z; Kissel, P

    1993-08-01

    The purpose of this clinical trial was to compare the efficacy of a new flossing aid (Flosser) with finger flossing on preventing plaque and gingival inflammation. 35 adults who did not use dental floss routinely were assigned randomly to one of 2 treatment groups (Flosser or finger flossing) in a 2-period, single-blind crossover study. After prophylaxis, subjects were instructed to use the flossing aid or finger floss 1 x per day and to continue brushing for 30 days. Gingival inflammation (GI & BPI) and plaque (PI) were assessed prior to the prophylaxis and at 30 days. After a 30 day "washout" period, subjects were again reassessed for gingival inflammation and plaque, given a prophylaxis, assigned the opposite treatment (2nd treatment period) that they received the first treatment period, and assessed (GI, BPI & PI) after 30 days. Comparing the mean difference of the 30-day buccal interproximal scores between the treatment groups (flossing aid scores minus finger flossing scores) showed that the mean differences with 95% CI were: -0.013 +/- 0.067 [GI], -0.017 +/- 0.044 [BP] and 0.019 +/- 0.014 [PI]. No statistically significant differences from zero (0.05 alpha) were observed using the t-test. There was a high level of compliance (90%) with the prescribed regiment, and subjects preferred (56%) the flossing aid slightly over finger flossing. Even though there were no statistically or clinically significant differences in gingivitis and plaque scores between the 2 flossing groups, the positive inclination for the flossing aid makes it a desirable addition to the armamentarium of preventive dentistry.

  16. A prospective study of the efficacy of magnetic resonance spectroscopy imaging for predicting locally advanced prostate cancer

    PubMed Central

    Razi, Ali; Parizi, Mehdi Kardoust; Kazemeini, Seid Mohammad; Abedi, Akbar

    2015-01-01

    Objective: To evaluate the efficacy of magnetic resonance spectroscopy imaging (MRSI) for predicting locally advanced prostate cancer (PC). Materials and methods: Between April 2009 and July 2012, 80 consecutive patients with clinically localized PC had undergone endorectal MRSI before radical retropubic prostatectomy. Clinicopathological parameters, including age, preoperative prostate-specific antigen (PSA), Gleason score (GS) at biopsy, perinural invasion at biopsy, prostate weight at surgery, GS of surgical specimen, and pathological staging were recorded. The MRSI findings were compared with the histopathological findings of the radical prostatectomy. The diagnostic accuracy measures consisting of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of MRSI, and other variables in the diagnosis of locally advanced PC (Pathology Stages pT3a, pT3b, or pT4) were evaluated. Results: Sensitivity, specificity, PPV, and NPV of MRSI in detecting locally advanced PC is 42.4%, 93.6%, 82.3%, and 69.8%, respectively [area under the receiver operating characteristic (ROC) curve=0.658, p value <0.0001]. MRSI, cancer-positive core percentage at biopsy, and GS at biopsy are more accurate factors among all the predictive variables in predicting locally advanced PC. Conclusion: MRSI may be considered as a complementary diagnostic modality with high specificity and moderate sensitivity in predicting locally advanced PC. Combination of this modality with other predictive factors helps the surgeon and patient to select an appropriate treatment strategy. PMID:26328204

  17. Formula to evaluate efficacy of vaccines and systemic substances against three-host ticks.

    PubMed

    Aguirre, André de Abreu Rangel; Garcia, Marcos Valério; Szabó, Matias Pablo Juan; Barros, Jacqueline Cavalcante; Andreotti, Renato

    2015-05-01

    The control of ticks with vaccines is of global interest. Experimental vaccines incorporate new technologies as soon as they are available. Historically, the main vaccine studies have focused on the one-host cattle tick Rhipicephalus microplus, and efficacy evaluations have been standardised for this tick species. On the other hand, evaluations of vaccine candidates for three-host ticks are being done somewhat arbitrarily and thus comparisons within the current literature on the efficacy of vaccines, as well as other methods of control, are difficult. We herein provide a formula for the evaluation of efficacy of a vaccine designed against three-host ticks that incorporates the whole life cycle of the tick. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  18. Efficacy of using Zaontz urethral stent in hypospadias repair by the Face, Legs, Activity, Cry, Consolability (FLACC) scale: A prospective study

    PubMed Central

    Ozcan, Serkan; Bagcioglu, Murat; Karakan, Tolga; Diri, Mehmet Akif; Demirbas, Arif

    2017-01-01

    Introduction: The developments in hypospadias surgical techniques and materials are intended to improve surgery outcomes and patient comfort. The aim of this study is to determine the effect of the Zaontz urethral stent (ZUS) (Cook Medical) on patient comfort and surgical success rates in children undergoing hypospadias surgery. Methods: A feeding tube was used to repair 46 cases of primary distal hypospadias, and ZUS (6F, 8F, and 10F in diameter) was used to repair to 31 cases of primary distal hypospadias between December 2009 and June 2011 in our clinic. ZUS was compared with the feeding tube in terms of surgical success rates and patient comfort in assessments made during postoperative periods. Results: The patients with ZUS were followed with a stent for seven days postoperatively, as were the patients with the feeding tube. There was no statistical difference between the two groups in terms of fistula formation (p>0.05). Patient comfort was evaluated by the Face, Legs, Activity, Cry, Consolability (FLACC) scale on the first and third postoperative days, and a statistically significant difference was observed in favour of ZUS on the third postoperative day (p<0.05). Conclusions: Compared with a feeding tube in hypospadias repair, ZUS does not make any contribution to the urinary fistula rates. However, ZUS may have an advantage in terms of patient comfort in the postoperative followup. On the other hand, the small number of patients and the high price of the ZUS were the most important limitations. Prospective, randomized trials are needed to assess efficacy and cost. PMID:28163807

  19. The Efficacy and Tolerability of the Clonidine Transdermal Patch in the Treatment for Children with Tic Disorders: A Prospective, Open, Single-Group, Self-Controlled Study.

    PubMed

    Song, Pan-Pan; Jiang, Li; Li, Xiu-Juan; Hong, Si-Qi; Li, Shuang-Zi; Hu, Yue

    2017-01-01

    To evaluate the efficacy and tolerability of a clonidine transdermal patch in the treatment of children with tic disorders (TD) and to establish a predictive model for patients. Forty-one patients who met the inclusion criteria entered into 12 weeks of prospective, open, single-group, self-controlled treatment with a clonidine transdermal patch. The Yale Global Tic Severity Scale (YGTSS) was employed before therapy (baseline) and at 4, 8, and 12 weeks after therapy. (1) The total effect rates of treatment with a clonidine transdermal patch were 29.27, 53.66, and 63.41% at 4, 8, and 12 weeks, respectively. Compared with the baseline, the differences were significant at three different observation periods. (2) Compared to the level of 25% reduction, there were significant decreases in the score-reducing rate of motor tic and total tic severities at 12 weeks. (3) If the disease course was ≤24 months and the motor tic score was <16 at the baseline, there was an effective rate of 100% for treatment with the clonidine transdermal patch. If the disease course was ≤24 months and the motor tic score was >16, there was an effective rate of 57.1%. If the disease course was >24 months and the clinical classification was chronic TD, there was an effective rate of 62.5%. If the disease course was >24 months and the clinical classification was Tourette's syndrome, 90% of the patients were invalid. (4) The main adverse events were rash, slight dizziness, and headache. (1) When patients were pretreated with a D2-dopamine receptor antagonist that was ineffective or not tolerated well, switching to a clonidine transdermal patch treatment was effective and safe. (2) A clonidine transdermal patch could be a first-line medication for mild and moderate TD cases that are characterized by motor tics.

  20. Making hard choices easier: a prospective, multicentre study to assess the efficacy of a fertility-related decision aid in young women with early-stage breast cancer

    PubMed Central

    Peate, M; Meiser, B; Cheah, B C; Saunders, C; Butow, P; Thewes, B; Hart, R; Phillips, K-A; Hickey, M; Friedlander, M

    2012-01-01

    Background: Fertility is a priority for many young women with breast cancer. Women need to be informed about interventions to retain fertility before chemotherapy so as to make good quality decisions. This study aimed to prospectively evaluate the efficacy of a fertility-related decision aid (DA). Methods: A total of 120 newly diagnosed early-stage breast cancer patients from 19 Australian oncology clinics, aged 18–40 years and desired future fertility, were assessed on decisional conflict, knowledge, decision regret, and satisfaction about fertility-related treatment decisions. These were measured at baseline, 1 and 12 months, and were examined using linear mixed effects models. Results: Compared with usual care, women who received the DA had reduced decisional conflict (β=−1.51; 95%CI: −2.54 to 0.48; P=0.004) and improved knowledge (β=0.09; 95%CI: 0.01–0.16; P=0.02), after adjusting for education, desire for children and baseline uncertainty. The DA was associated with reduced decisional regret at 1 year (β=−3.73; 95%CI: −7.12 to −0.35; P=0.031), after adjusting for education. Women who received the DA were more satisfied with the information received on the impact of cancer treatment on fertility (P<0.001), fertility options (P=0.005), and rated it more helpful (P=0.002), than those who received standard care. Conclusion: These findings support widespread use of this DA shortly after diagnosis (before chemotherapy) among younger breast cancer patients who have not completed their families. PMID:22415294

  1. Influence of bariatric surgery on quality of life, body image, and general self-efficacy within 6 and 24 months-a prospective cohort study.

    PubMed

    Nickel, Felix; Schmidt, Lukas; Bruckner, Thomas; Büchler, Markus W; Müller-Stich, Beat-Peter; Fischer, Lars

    2017-02-01

    It has been proven that bariatric surgery affects weight loss. Patients with morbid obesity have a significantly lower quality of life (QOL) and body image compared with the general population. To evaluate QOL, body image, and general self-efficacy (GSE) in patients with morbid obesity undergoing bariatric surgery within clinical parameters. Monocentric, prospective, longitudinal cohort study. Patients completed the short form 36 (SF-36) for QOL, body image questionnaire, and GSE scale 3 times: before surgery and within 6 months and 24 months after surgery. Influence of gender, age, and type of procedure, either laparoscopic sleeve gastrectomy (SG) or laparoscopic Roux-en-Y gastric bypass, were analyzed. Thirty patients completed the questionnaires before and within 6 and 24 months after surgery. SF-36 physical summary score improved significantly from 34.3±11.0 before surgery to 46.0±10.4 within 6 months (P<.001) and to 49.8±8.2 within 24 months (P<.001) after surgery. SF-36 mental summary score improved significantly from 42.1±14.7 before surgery to 52.3±8.4 within 6 months (P<.001) and to 48.4±12.2 within 24 months (P<.001) after surgery. There were no significant differences between gender, age, and type of operation. Body image and GSE improved significantly after bariatric surgery (P<.001), and both correlated to the SF-36 mental summary score. QOL, body image, and GSE improved significantly within 6 months and remained stable within 24 months after bariatric surgery. Improvements were independent of gender, age, and type of operation. Mental QOL was influenced by body image and GSE. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  2. Efficacy of immediate instillation combined with regular instillations of pirarubicin for Ta and T1 transitional cell bladder cancer after transurethral resection: a prospective, randomized, multicenter study.

    PubMed

    Li, Ning-chen; Ye, Zhang-qun; Na, Yan-qun

    2013-01-01

    Immediate intravesical instillation of chemotherapeutic agents after transurethral resection (TUR) of nonmuscle invasive transitional cell bladder cancer has recently been suggested and has been proven to decrease the tumor recurrence rate significantly. This study is to evaluate the efficacy and safety of immediate intravesical instillation combined with regular instillations of Pirarubicin (THP(®)) as prophylaxis compared to regular instillations only after TUR operation. This was a prospective, randomized, multi-center, clinical study. Patients diagnosed with non-muscle invasive bladder cancer (Ta and T1) pathologically and suitable for TUR were enrolled randomly into two groups. In the study group, the patients received intravesical instillation within 24-hour post TURBT, followed by regular intravesical therapy using 30 mg/50 ml of THP(®) once a week for 8 weeks, and then once a month to 1 year postoperatively Among the patients. In the control group, patients received regular instillation only. A total of 403 patients were enrolled into this study from 26 institutions in China. Among the potients, 210 were enrolled into the study group and 193 were enrolled into the control group. At the median follow-up of 18 months, the recurrence rate was 7.8% in the study group, significantly lower than that in the control group (14.3%; P = 0.042). Subgroup analysis showed that the recurrence rate in low and intermediate-risk patients was significantly lower in the study group (6.8%) than in the control group (14.0%; P = 0.047), although no significant differences were found in high-risk patients. One immediate dose of THP(®) 30 mg after TURBT followed by regular intravesical therapy appears well tolerated and more effective than regular intravesical therapy for preventing tumor recurrence, especially in low and intermediate-risk patients.

  3. A Bayesian model for evaluating influenza antiviral efficacy in household studies with asymptomatic infections.

    PubMed

    Yang, Yang; Halloran, M Elizabeth; Longini, Ira M

    2009-04-01

    Antiviral agents are an important component in mitigation/containment strategies for pandemic influenza. However, most research for mitigation/containment strategies relies on the antiviral efficacies evaluated from limited data of clinical trials. Which efficacy measures can be reliably estimated from these studies depends on the trial design, the size of the epidemics, and the statistical methods. We propose a Bayesian framework for modeling the influenza transmission dynamics within households. This Bayesian framework takes into account asymptomatic infections and is able to estimate efficacies with respect to protecting against viral infection, infection with clinical disease, and pathogenicity (the probability of disease given infection). We use the method to reanalyze 2 clinical studies of oseltamivir, an influenza antiviral agent, and compare the results with previous analyses. We found significant prophylactic efficacies in reducing the risk of viral infection and infection with disease but no prophylactic efficacy in reducing pathogenicity. We also found significant therapeutic efficacies in reducing pathogenicity and the risk of infection with disease but no therapeutic efficacy in reducing the risk of viral infection in the contacts.

  4. Efficacy and safety of sugammadex in the reversal of deep neuromuscular blockade induced by rocuronium in patients with end-stage renal disease: A comparative prospective clinical trial.

    PubMed

    de Souza, Camila M; Tardelli, Maria A; Tedesco, Helio; Garcia, Natalia N; Caparros, Mario P; Alvarez-Gomez, Jose A; de Oliveira Junior, Itamar S

    2015-10-01

    Renal failure affects the pharmacology of nondepolarizing neuromuscular blockers making recovery of neuromuscular function unpredictable. Sugammadex antagonises rocuronium-induced neuromuscular blockade by encapsulating rocuronium, creating a stable complex molecule that is mainly excreted by the kidneys. Previous studies suggest that sugammadex is effective in reversing moderate neuromuscular block in the presence of renal failure, but no data are available regarding reversal of profound neuromuscular block in patients with renal failure. The objective of this study is to compare the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in patients with end-stage renal disease and those with normal renal function. A prospective clinical trial. Two university hospitals, from 1 October 2011 to 31 January 2012. Forty patients undergoing kidney transplant: 20 with renal failure [creatinine clearance (ClCr) <30 ml min] and 20 control patients (ClCr >90 ml min). Neuromuscular monitoring was performed by acceleromyography and train-of-four (TOF) stimulation. Profound neuromuscular block (posttetanic count, one to three responses) was maintained during surgery. Sugammadex 4 mg kg was administered on completion of skin closure. Recovery of the TOF ratio to 0.9 was recorded. Monitoring of neuromuscular function continued in the postanesthesia care unit for a further 2 h. The efficacy of sugammadex was evaluated by the time taken for the TOF ratio to recover to 0.9. The safety of sugammadex was assessed by monitoring for recurrence of neuromuscular block every 15 min for 2 h. Secondary variables were time to recovery of TOF ratio to 0.7 and 0.8. After sugammadex administration, the mean time for recovery of the TOF ratio to 0.9 was prolonged in the renal failure group (5.6 ± 3.6 min) compared with the control group (2.7 ± 1.3 min, P = 0.003). No adverse events or evidence of recurrence of

  5. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

    PubMed Central

    Saha, Suparna Ganguly; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

    2016-01-01

    Introduction It is generally accepted that achieving complete anaesthesia with an Inferior Alveolar Nerve Block (IANB) in mandibular molars with symptomatic irreversible pulpitis is more challenging than for other teeth. Therefore, administration of Non-Steroidal Anti-Inflammatory Agents (NSAIDs) 1 hour prior to anaesthetic administration has been proposed as a means to increase the efficacy of the IANB in such patients. Aim The purpose of this prospective, double-blind, randomized clinical trial was to determine the effect of administration of oral premedication with ketorolac (KETO) and diclofenac potassium (DP) on the efficacy of IANB in patients with irreversible pulpitis. Materials and Methods One hundred and fifty patients with irreversible pulpitis were evaluated preoperatively for pain using Heft Parker visual analogue scale, after which they were randomly divided into three groups. The subjects received identical tablets of ketorolac, diclofenac pottasium or cellulose powder (placebo), 1 hour prior to administration of IANB with 2% lidocaine containing 1:200 000 epinephrine. Lip numbness as well as positive and negative responses to cold test were ascertained. Additionally pain score of each patient was recorded during cavity preparation and root canal instrumentation. Success was defined as the absence of pain or mild pain based on the visual analog scale readings. The data was analysed using One-Way Anova, Post-Hoc Tukey pair wise, Paired T – Test and chi-square test. Trial Registery Number is 4722/2015 for this clinical trial study. Results There were no significant differences with respect to age (p =0.098), gender (p = 0.801) and pre-VAS score (DP-KETO p=0.645, PLAC-KETO p =0.964, PLAC-DP p = 0.801) between the three groups. All patients had subjective lip anaesthesia with the IAN blocks. Patients of all the three groups reported a significant decrease in active pain after local anaesthesia (p< 0.05). The post injection VAS Score was least in group

  6. A Study on Prospective Teachers' Self-Efficacy Beliefs Regarding the Implementation of Constructivist Approach (A Case of Konya)

    ERIC Educational Resources Information Center

    Ektem, Isil Sönmez

    2016-01-01

    The purpose of this study was to reveal prospective teachers' perceptions and views about the implementation of the constructivist approach. The study was conducted on 528 prospective teachers in their 4th year at Necmettin Erbakan University Ahmet Kelesoglu Education Faculty and Selcuk University Faculty of Science and Faculty of Letters in the…

  7. Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post-marketing surveillance.

    PubMed

    Torii, Hideshi; Terui, Tadashi; Matsukawa, Miyuki; Takesaki, Kazumi; Ohtsuki, Mamitaro; Nakagawa, Hidemi

    2016-07-01

    A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma. © 2015 Japanese Dermatological Association.

  8. Evaluating the efficacy of wood shreds for mitigating erosion

    Treesearch

    Randy B. Foltz; Natalie S. Copeland

    2009-01-01

    An erosion control product made by shredding on-site woody materials was evaluated for mitigating erosion through a series of rainfall simulations. Tests were conducted on bare soil and soil with 30, 50, and 70% cover on a coarse and a fine-grained soil. Results indicated that the wood product known as wood shreds reduced runoff and soil loss from both soil types....

  9. Effects of Self-Efficacy on Healthy Eating Depends on Normative Support: a Prospective Study of Long-Haul Truck Drivers.

    PubMed

    Hamilton, Kyra; Hagger, Martin S

    2017-08-28

    Fruit and vegetable intake (FV) is insufficient in industrialized nations and there is excess of discretionary food choices (DC; foods high in fat, sugar, and salt). Long-haul truck drivers are considered a particularly at-risk group given the limited food choices and normatively reinforced eating habits at truck rest-stops. Self-efficacy and normative support are key determinants of eating behavior yet the processes underlying their effects on behavior are not well understood. We tested the direct and interactive effects of self-efficacy and normative support on healthy eating behaviors in long-haul truck drivers in a prospective correlational study. Long-haul truck drivers (N = 82) completed an initial survey containing self-report measures of behavioral intentions, perceived normative support, and self-efficacy for their FV and DC behaviors. Participants completed a follow-up survey 1 week later in which they self-reported their FV and DC behavior. A mediated moderation analysis identified an interactive effect of self-efficacy and normative support on behavior mediated by intention for FV and DC behavior. Specifically, we confirmed a compensation effect in which self-efficacy was more likely to have an effect on FV and DC behavior through intentions in participants with low normative support. Results indicate the importance of self-efficacy in predicting FV and DC intentions and behavior in the absence of a supportive normative environment. The compensatory effect of self-efficacy beliefs on behavior through intentions when normative support is low should be confirmed using experimental methods.

  10. [Systematic evaluation for efficacy of tripterygium glycosides in treating diabetic nephropathy stage IV].

    PubMed

    Huang, Jing; Zhang, Ji-qiang; Chen, Zheng; Zhang, Yan; Chen, Wei-dong; Wu, Xue-ping

    2015-08-01

    To systematically evaluate the efficacy and safety of tripterygium glycosides (TG) combined with ACEI/ARB preparation in treating diabetic nephropathy stage IV. The computer retrievals were made in Cochrane Libarary, PubMed, Embase, SCI, Sinnomed, CNKI, Chinainfo and VIP, and hand retrievals were conducted for meeting and academic papers (updated to December 30, 2014), in order to collect randomized controlled trials and quasi-randomized control trials for TG combined with ACEI/ARB preparation in treating diabetic nephropathy stage IV and set the literature inclusion and elimination standards. Eligible literatures were included and evaluated according to standards in Cochrane Handbook. RevMan 5.3 and Stata 12.0 were used for a Meta-analysis. A total of 13 randomized controlled trials and quasi-randomized control trials involving 1119 patients with diabetic nephropathy were included. The Meta analysis result showed that compared with the control group, the combination group showed better effects in reducing the 24-hour urinary protein [MD = -0.84, 95% CI (-1.02, -0.66)], raising albumin [SMD = 0.98, 95% CI (0.81, 1.16)], the total efficiency [OR = 4.23, 95% CI (2.77, 6.46)] and the significant efficiency [OR = 5.35, 95% CI (2.70, 10.60)], with no statistical difference in Serum Creatinine between Both groups [MD = -0.82, 95% CI (-4.30, 2.66), P = 0.64]. However, the risk of adverse reactions increased by 7% [RD = 0.07, 95% CI (0.03, 0.12)]. The Egger's test showed no publication bias. Tripterygium Glycosides combined with ACEI/ARB in treating diabetic nephropathy stage IV is supper than the single administration of ACEI/ARB, with a good prospect in clinical application. Nevertheless, due to the small-size and low-quality samples in this study, more high-quality and large sample-size randomized controlled trials shall be conducted to verify the findings.

  11. 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

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

    PubMed

    Bacić, Ivan; Druzijanić, Nikica; Karlo, Robert; Skifić, Ivan; Jagić, Stjepan

    2010-02-12

    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 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. 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. 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.

  13. Algorithms for detecting and predicting influenza outbreaks: metanarrative review of prospective evaluations

    PubMed Central

    Spreco, A; Timpka, T

    2016-01-01

    Objectives Reliable monitoring of influenza seasons and pandemic outbreaks is essential for response planning, but compilations of reports on detection and prediction algorithm performance in influenza control practice are largely missing. The aim of this study is to perform a metanarrative review of prospective evaluations of influenza outbreak detection and prediction algorithms restricted settings where authentic surveillance data have been used. Design The study was performed as a metanarrative review. An electronic literature search was performed, papers selected and qualitative and semiquantitative content analyses were conducted. For data extraction and interpretations, researcher triangulation was used for quality assurance. Results Eight prospective evaluations were found that used authentic surveillance data: three studies evaluating detection and five studies evaluating prediction. The methodological perspectives and experiences from the evaluations were found to have been reported in narrative formats representing biodefence informatics and health policy research, respectively. The biodefence informatics narrative having an emphasis on verification of technically and mathematically sound algorithms constituted a large part of the reporting. Four evaluations were reported as health policy research narratives, thus formulated in a manner that allows the results to qualify as policy evidence. Conclusions Awareness of the narrative format in which results are reported is essential when interpreting algorithm evaluations from an infectious disease control practice perspective. PMID:27154479

  14. [Efficacy of the analytic approach in evaluation of biofilter activity in a composting system].

    PubMed

    Fiore, Maria; Cicciù, Francesca; Cunsolo, Maria; Fallico, Roberto; Sciacca, Salvatore; Ferrante, Margherita

    2011-01-01

    Composting may present certain technical problems which can negatively influence results in terms of environmental impact as well as of profit and loss account. The aim of this study was to estimate the efficacy of the analytic approach to evaluate the effect of removing the biofilter in a composting system. Results have shown the presence of foul-smelling emissions despite the fact that concentrations of investigated substances were well below the danger threshold or even below the method's detection threshold. Therefore, besides the analytic approach, the most reasonable choice seems to be introducing a reference method for evaluating odour emissions and the efficacy of composting systems.

  15. Experimental evaluation of self-efficacy treatment on technical/scientific career outcomes

    NASA Astrophysics Data System (ADS)

    Dawes, Mary Ellen

    Research literature was reviewed concerning the career choices of women, whose talents and abilities continue to be underutilized in many technical and scientific fields. Based on self-efficacy theory, it has been proposed that limited experience results in low self-efficacy beliefs and career interest in technical and scientific fields among women. This study experimentally evaluated a technology education program designed to provide mastery experiences described in self-efficacy theory and predicted to improve career decision making. Seventh and eighth grade students (n=169) were stratified on grade level and randomly assigned either to a published technology education program or to control curricula. Over a 7-week period, the experimental program attempted to foster exploration and performance accomplishments in the students' choice of 3 (out of 21 possible) technical and scientific careers. Pre- and post-test instruments assessed technical/scientific self-efficacy and career interest. No treatment effects were found. However, a demand measure did show significantly greater valuing of the technology education program over the control curricula. It was also noted that students self-selected technology modules for study, and likely selected modules indicating their highest self-efficacy and career interest, which may have limited possible findings. In future research, targeting students with the greatest discrepancy between self-efficacy and performance ability might be more definitive. It should also be noted that the technology education program incorporated elements of self-efficacy theory, but did not include all components. Additional work is necessary to evaluate self-efficacy treatment in career development.

  16. The short-term efficacy of laser, brace, and ultrasound treatment in lateral epicondylitis: a prospective, randomized, controlled trial.

    PubMed

    Oken, Oznur; Kahraman, Yaşar; Ayhan, Figen; Canpolat, Sabahat; Yorgancioglu, Z Rezan; Oken, O Fuad

    2008-01-01

    The aims of this study were to evaluate the effects of low-level laser therapy (LLLT) and to compare these with the effects of brace or ultrasound (US) treatment in tennis elbow. The study design used was a prospective and randomized, controlled, single-blind trial. Fifty-eight outpatients with lateral epicondylitis (9 men, 49 women) were included in the trial. The patients were divided into three groups: 1) brace group-brace plus exercise, 2) ultrasound group-US plus exercise, and 3) laser group-LLLT plus exercise. Patients in the brace group used a lateral counterforce brace for three weeks, US plus hot pack in the ultrasound group, and laser plus hot pack in the LLLT group. In addition, all patients were given progressive stretching and strengthening exercise programs. Grip strength and pain severity were evaluated with visual analog scale (VAS) at baseline, at the second week of treatment, and at the sixth week of treatment. VAS improved significantly in all groups after the treatment and in the ultrasound and laser groups at the sixth week (p<0.05). Grip strength of the affected hand increased only in the laser group after treatment, but was not changed at the sixth week. There were no significant differences between the groups on VAS and grip strength at baseline and at follow-up assessments. The results show that, in patients with lateral epicondylitis, a brace has a shorter beneficial effect than US and laser therapy in reducing pain, and that laser therapy is more effective than the brace and US treatment in improving grip strength.

  17. Evaluation of a Geothermal Prospect Using a Stochastic Joint Inversion Algorithm

    NASA Astrophysics Data System (ADS)

    Tompson, A. F.; Mellors, R. J.; Ramirez, A.; Dyer, K.; Yang, X.; Trainor-Guitton, W.; Wagoner, J. L.

    2013-12-01

    A stochastic joint inverse algorithm to analyze diverse geophysical and hydrologic data for a geothermal prospect is developed. The purpose is to improve prospect evaluation by finding an ensemble of hydrothermal flow models that are most consistent with multiple types of data sets. The staged approach combines Bayesian inference within a Markov Chain Monte Carlo (MCMC) global search algorithm. The method is highly flexible and capable of accommodating multiple and diverse datasets as a means to maximize the utility of all available data to understand system behavior. An initial application is made at a geothermal prospect located near Superstition Mountain in the western Salton Trough in California. Readily available data include three thermal gradient exploration boreholes, borehole resistivity logs, magnetotelluric and gravity geophysical surveys, surface heat flux measurements, and other nearby hydrologic and geologic information. Initial estimates of uncertainty in structural or parametric characteristics of the prospect are used to drive large numbers of simulations of hydrothermal fluid flow and related geophysical processes using random realizations of the conceptual geothermal system. Uncertainty in the results is represented within a ranked subset of model realizations that best match all available data within a specified norm or tolerance. Statistical (posterior) characteristics of these solutions reflect reductions in the perceived (prior) uncertainties. This work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344. LLNL-ABS-641792.

  18. Evaluating the efficacy of a chemistry video game

    NASA Astrophysics Data System (ADS)

    Shapiro, Marina

    A quasi-experimental design pre-test/post-test intervention study utilizing a within group analysis was conducted with 45 undergraduate college chemistry students that investigated the effect of implementing a game-based learning environment into an undergraduate college chemistry course in order to learn if serious educational games (SEGs) can be used to achieve knowledge gains of complex chemistry concepts and to achieve increase in students' positive attitude toward chemistry. To evaluate if students learn chemistry concepts by participating in a chemistry game-based learning environment, a one-way repeated measures analysis of variance (ANOVA) was conducted across three time points (pre-test, post-test, delayed post-test which were chemistry content exams). Results showed that there was an increase in exam scores over time. The results of the ANOVA indicated a statistically significant time effect. To evaluate if students' attitude towards chemistry increased as a result of participating in a chemistry game-based learning environment a paired samples t-test was conducted using a chemistry attitudinal survey by Mahdi (2014) as the pre- and post-test. Results of the paired-samples t-test indicated that there was no significant difference in pre-attitudinal scores and post-attitudinal scores.

  19. Lack of efficacy of manual therapy in children and adolescents with suspected cervicogenic headache: results of a prospective, randomized, placebo-controlled, and blinded trial.

    PubMed

    Borusiak, Peter; Biedermann, Heiner; Bosserhoff, Stephanie; Opp, Joachim

    2010-02-01

    Clinical trials concerning cervical spine manipulation and mobilization in children and adolescents with cervicogenic headache are lacking. We performed a multicenter, prospective, randomized, placebo-controlled, and blinded trial in 52 children and adolescents (21 boys, 31 girls) aged 7-15. After prospective baseline documentation for 2 months patients were either assigned to placebo or true manipulation with another 2-month follow-up. Main outcome measures were defined as: percentage of days with headache, total duration of headache, days with school absence due to headache, consume of analgesics, intensity of headache. We did not find a significant difference comparing the groups with placebo and true manipulation with respect to the defined main outcome measures. We were not able to show an efficacy of cervical spine manipulation in 52 children and adolescents.

  20. Evaluation Of Shielding Efficacy Of A Ferrite Containing Ceramic Material

    SciTech Connect

    Verst, C.

    2015-10-12

    The shielding evaluation of the ferrite based Mitsuishi ceramic material has produced for several radiation sources and possible shielding sizes comparative dose attenuation measurements and simulated projections. High resolution gamma spectroscopy provided uncollided and scattered photon spectra at three energies, confirming theoretical estimates of the ceramic’s mass attenuation coefficient, μ/ρ. High level irradiation experiments were performed using Co-60, Cs-137, and Cf-252 sources to measure penetrating dose rates through steel, lead, concrete, and the provided ceramic slabs. The results were used to validate the radiation transport code MCNP6 which was then used to generate dose rate attenuation curves as a function of shielding material, thickness, and mass for photons and neutrons ranging in energy from 200 keV to 2 MeV.

  1. The efficacy of cefazolin in reducing surgical site infection in laparoscopic cholecystectomy: a prospective randomized double-blind controlled trial.

    PubMed

    Ruangsin, Sakchai; Laohawiriyakamol, Supparerk; Sunpaweravong, Somkiat; Mahattanobon, Somrit

    2015-04-01

    A prophylactic antibiotic is recommended in open cholecystectomy surgeries, but in laparoscopic cholecystectomies such prophylaxis is controversial. Recent reviews have not found conclusive evidence that routine prophylaxis, especially in low risk patients, is effective. This clinical trial was undertaken to evaluate the efficacy of cefazolin in reducing surgical site infection SSI in laparoscopic cholecystectomies in a sample not screened for high or low risk patients. A randomized double-blind controlled trial was conducted in a single university hospital. Scheduled cholecystectomy patients without selection for patient risk factors were randomized into two groups. Pre-operatively, group A patients received a placebo of 10 ml isotonic sodium chloride, and group B patients received 1 g of cefazolin as a prophylactic antibiotic. All patients underwent a standard laparoscopic cholecystectomy, and were followed up for at least 30 days. Two hundred ninety-nine patients were randomized (149 in group A and 150 in group B). SSI occurred in seven patients (2.34 %), five (1.67 %) in the placebo group, and two (0.67 %) in the prophylactic antibiotic group. The difference was not statistically significant (p value = 0.512), and no specific risk factors for post-operative infection were identified. A single dose of preoperative prophylactic cefazolin has no significant benefit in reducing the incidence of SSI in laparoscopic cholecystectomy. Whether or not to use a prophylactic depends on the individual patient, and the consideration of the attending surgeon.

  2. Retraction statement: Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers.

    PubMed

    2015-09-01

    The following article from Journal of Clinical Nursing, 'Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers' by Georgina Gethin and Seamus Cowman published online on 25 August 2008 in Wiley Online Library (wileyonlinelibrary.com) and in Volume 18, pp. 466-474, has been retracted by agreement between the journal Editor-in-Chief, the authors and John Wiley & Sons, Ltd. The retraction has been agreed due to errors in the data analysis which affect the article's findings.

  3. Nefazodone in psychotic unipolar and bipolar depression: a retrospective chart analysis and open prospective study on its efficacy and safety versus combined treatment with amitriptyline and haloperidol.

    PubMed

    Grunze, Heinz; Marcuse, Alain; Schärer, Lars O; Born, Christoph; Walden, Jörg

    2002-01-01

    Although atypical antipsychotics are on the rise, traditional treatment of psychotic (or delusional) depression mostly includes the addition of classical antipsychotics to antidepressants. As there are only few data supporting this approach compared with antidepressant monotherapy, and almost no data comparing it with antidepressants of the latest generation, we conducted a retrospective chart analysis and a prospective, randomized open study on the efficacy and tolerability of nefazodone monotherapy versus combined treatment with amitriptyline and haloperidol in psychotic depression. The results suggest that the addition of classical antipsychotics should be reserved for those with very severe psychotic symptoms, but may not be needed in milder forms. Copyright 2003 S. Karger AG, Basel

  4. Evaluation of the pressure ulcers risk scales with critically ill patients: a prospective cohort study 1

    PubMed Central

    Borghardt, Andressa Tomazini; do Prado, Thiago Nascimento; de Araújo, Thiago Moura; Rogenski, Noemi Marisa Brunet; Bringuente, Maria Edla de Oliveira

    2015-01-01

    AIMS: to evaluate the accuracy of the Braden and Waterlow risk assessment scales in critically ill inpatients. METHOD: this prospective cohort study, with 55 patients in intensive care units, was performed through evaluation of sociodemographic and clinical variables, through the application of the scales (Braden and Waterlow) upon admission and every 48 hours; and through the evaluation and classification of the ulcers into categories. RESULTS: the pressure ulcer incidence was 30.9%, with the Braden and Waterlow scales presenting high sensitivity (41% and 71%) and low specificity (21% and 47%) respectively in the three evaluations. The cut off scores found in the first, second and third evaluations were 12, 12 and 11 in the Braden scale, and 16, 15 and 14 in the Waterlow scale. CONCLUSION: the Braden scale was shown to be a good screening instrument, and the Waterlow scale proved to have better predictive power. PMID:25806628

  5. Computed tomography alone may clear the cervical spine in obtunded blunt trauma patients: a prospective evaluation of a revised protocol.

    PubMed

    Como, John J; Leukhardt, William H; Anderson, James S; Wilczewski, Patricia A; Samia, Hoda; Claridge, Jeffrey A

    2011-02-01

    Cervical spine (CS) clearance in obtunded blunt trauma patients (OBTPs) remains controversial. When computed tomography (CT) of the CS is negative for injury, debate continues over the role of magnetic resonance imaging (MRI). Use of MRI in OBTPs is costly, time-consuming, and potentially dangerous. Our study evaluated the safety of a protocol to discontinue the cervical collar in OBTPs based on CT scan alone. A prospective study was performed from October 2006 to September 2008 at a regional Level I trauma center on OBTPs with gross movement of all extremities. After a CT of the CS was read as negative for injury, the CS was cleared and the collar was removed. Patients were then followed prospectively for related complications. One hundred ninety-seven patients had their collars removed and CS cleared at a mean of 3.3 days. There were 144 males (73%), and the average age was 47.1 years. Sixty-two percent of patients were reexamined by a physician when no longer obtunded and found to have no CS signs or symptoms. Five patients (2.5%), when no longer obtunded, had persistent pain for which MRI CS was negative for injury. Coroner reports and autopsies were reviewed for missed spinal cord injuries in the 13% who died before reexamination. One of these patients had an autopsy report of an isolated CS ligamentous injury, deemed to be stable by our attending neurosurgeon. We followed up an additional 12% by phone or chart review, with no report of new onset neurologic deficit. The remaining 11% were lost to follow-up, but no patient contacted our hospital to report deterioration in function. One patient (0.5%) developed a minor CS decubitus ulceration. Removal of CS precautions in OBTPs with gross movement of all extremities is safe and efficacious if CT CS is negative for injury. Supplemental MRI CS is not needed in this patient population.

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

    PubMed

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

    2016-09-01

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

  7. [Single Subcutaneous Palmar Injection vs. 2 Dorsal Injections for Finger Anaesthesia in Hand Surgery - Randomised Prospective Comparison of Application Pain and Efficacy].

    PubMed

    Schelhorn, N; Lamm, S; Fricker, R

    2016-08-01

    This randomised prospective study compared pain during application and efficacy of the palmar subcutaneous single injection block (PSSIB) and the traditional dorsal 2 injection block (DTIB). During a 2 year period, a total of 190 patients with an average age of 43 years (18-82) and an isolated finger injury were included in the study. The injection was applied by residents (n=29) of the emergency department. 96 patients received PSSIB (72 men, 24 women) and 94 DTIB (55 men, 39 women) with 3 ml of Mepicavain(®) 1%. Randomisation was performed by even/odd hospital admission number. Thumb injury, progressive infection with visible redness at injection point. Application pain was recorded immediately after injection and registered on a VAS (0-10). Efficacy was checked 5 min after application. The patients quoted the efficacy as complete pain-free, almost pain-free and inadequate anesthesia (second injection was necessary). Statistical analysis was performed using the chi-quadrat and the t test; the level of significance was set at p<0.05. There was no significant difference in terms of analgesic efficacy (p=0,096), while the PSSIB required fewer second injections. Application pain was rated as being significantly (p=0.002) less painful for PSSIB (3.2) than for DTIB (4,0). This study shows that PSSIB gives reliable analgesia and the application pain is significant less than during DTIB. © Georg Thieme Verlag KG Stuttgart · New York.

  8. Efficacy evaluation of selected herbicides on weed control and productivity evaluation of Bt cotton in Punjab.

    PubMed

    Singh, Kulvir; Rathore, Pankaj

    2015-07-01

    Field experiments were conducted during Kharif 2012 and 2013 to evaluate the efficacy of different herbicides for weed management in cotton. Highest seed cotton yield (3537.3 kg ha(-1)) was recorded in weed free plots followed by pendimethalin @1.0 kg a.i ha(-1) as Pre.em.+quizalofopethyl @50 g a.i ha(-1) post-em at 2-4 weed leaf stage + one hoeing (3318.9 kg ha") owing to improved number of bolls per plant and boll weight. Statistically least yield was recorded underweedy check (1435.4 kg ha(-1)). Application of pyrithiobac sodium could not express any visible toxic effect on crop indicating its selectivity for cotton, although none of the tested new chemicals i.e., pyrithiobac sodium@ 62.5g a.i ha(-1) and quizalofopethyl @50g a.i ha(-1) when applied alone could not outperform the existing recommended chemicals for weed management. Yield losses to the extent of 6.2-59.4% were recorded due to weed competition. Weed control efficiency (WCE) was highest under weed free check (86.8%) followed by pendimethalin @1.0 kg a.i ha(-1) as Pre. em.+quizalofopethyl @50g a.i ha(-1), at 2-4 weed leaf stage + one hoeing (73.7%), whereas minimum values were for weedy check (24.7%). Though net returns (r94660 ha(-1)) were highest for weed free check but higher B:C ratio (2:11) was observed for pendimethalin @1.0 kg a.i ha(-1) as Pre em.+quizalofopethyl @50 g a.i ha(-1) post-em at 2-4 weed leaf stage+one hoeing. Therefore, for reasons such as labor shortage besides their timely availability, using these herbicides in combination with cultural practices could be the practical solution foreconomically efficient and effective weed management.

  9. Evaluating the Efficacy of Mathematics, Science and Technology Teacher Preparation Academies in Texas

    ERIC Educational Resources Information Center

    Brown, Danielle Bairrington; Alford, Beverly L.; Rollins, Kayla Braziel; Stillisano, Jacqueline R.; Waxman, Hersh C.

    2013-01-01

    The purpose of this mixed-methods study was to evaluate the efficacy of 14 Mathematics, Science and Technology Teacher Preparation (MSTTP) academies located across the state of Texas. The aim of the academies was to increase the number of highly qualified mathematics, science and technology teachers, while also improving the quality of certified…

  10. Core Self-Evaluations, Career Decision Self-Efficacy, and Vocational Identity among Greek Adolescents

    ERIC Educational Resources Information Center

    Koumoundourou, Georgia A.; Kounenou, Kalliopi; Siavara, Eftyxia

    2012-01-01

    This study explored the mediating role of career decision self-efficacy between core self-evaluations (CSE), a newly established construct within the personality domain, and adolescents' vocational identity. Using a sample of 200 Greek high school students, it was found that for female adolescents CSE influenced vocational identity both directly…

  11. Evaluation of the Efficacy of a Dental Plaque Control Program in Autistic Patients

    ERIC Educational Resources Information Center

    Dias, Guilherme G.; Prado, Eliane F. G. B.; Vadasz, Estevao; Siqueira, Jose Tadeu T.

    2010-01-01

    The aim of this study was to verify the efficacy of a programme for dental plaque control in autistics. Patients were evaluated on five occasions over a period of 180 days using the following instruments: OHI-S, DMF-T, the Fonnes brushing technique and diet questionnaire. Participants were divided into two groups according to level of co-operation…

  12. Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

    ERIC Educational Resources Information Center

    Drits-Esser, Dina; Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K-12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The…

  13. An Interactive Web-Based Program for Stepfamilies: Development and Evaluation of Efficacy

    ERIC Educational Resources Information Center

    Gelatt, Vicky A.; Adler-Baeder, Francesca; Seeley, John R.

    2010-01-01

    This study evaluated the efficacy of a family life education program for stepfamilies that is self-administered, interactive, and web-based. The program uses behavior-modeling videos to demonstrate effective couple, parenting, and stepparenting practices. A diverse sample of 300 parents/stepparents of a child aged 11-15 years were randomized into…

  14. Evaluating treatment efficacy in commercial food facilities: Insights gained from small-scale simulated warehouse experiments

    USDA-ARS?s Scientific Manuscript database

    Although critical to a successful IPM program, it is challenging to evaluate treatment efficacy in commercial food facilities because of the inability to obtain absolute estimates of insect population levels. These populations are spatial fragmented and occupy cryptic habitats such as equipment, pa...

  15. Evaluating Treatment Efficacy in Commercial Food Facilities: Insights Gained from Small-Scale Simulated Warehouse Experiments

    USDA-ARS?s Scientific Manuscript database

    Although critical to a successful IPM program, it is challenging to evaluate treatment efficacy in commercial food facilities because of the inability to obtain absolute estimates of insect population levels. These populations are spatially fragmented and occupy cryptic habitats, such as equipment,...

  16. EVALUATING THE POTENTIAL EFFICACY OF AN ANTIMICROBIAL-CONTAINING SEALANT ON DUCT LINER AND GALVANIZED STEEL

    EPA Science Inventory

    The article gives results of an evaluation of the potential efficacy of an antimicrobial-containing sealant on fibrous-glass duct liner (FGDL) and galvanized steel (GS) as used in heating, ventilating, and air-conditioning (HVAC) systems. HVAC systems become dirty to various degr...

  17. Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

    ERIC Educational Resources Information Center

    Drits-Esser, Dina; Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K-12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The…

  18. EVALUATING THE POTENTIAL EFFICACY OF AN ANTIMICROBIAL-CONTAINING SEALANT ON DUCT LINER AND GALVANIZED STEEL

    EPA Science Inventory

    The article gives results of an evaluation of the potential efficacy of an antimicrobial-containing sealant on fibrous-glass duct liner (FGDL) and galvanized steel (GS) as used in heating, ventilating, and air-conditioning (HVAC) systems. HVAC systems become dirty to various degr...

  19. Ground-based spectral reflectance measurements for efficacy evaluation of aerially applied glyphosate treatments

    USDA-ARS?s Scientific Manuscript database

    Aerial application of herbicides is a common tool in agricultural field management. The objective of this study was to evaluate the efficacy of glyphosate herbicide applied aerially with both conventional and emerging aerial nozzle technologies. A Texas A&M University Plantation weed field was set u...

  20. Ground-based spectral reflectance measurements for evaluating the efficacy of aerially-applied glyphosate treatments

    USDA-ARS?s Scientific Manuscript database

    Aerial application of herbicides is a common tool in agricultural field management. The objective of this study was to evaluate the efficacy of glyphosate herbicide applied aerially with both conventional and emerging aerial nozzle technologies. A Texas A&M University Plantation weed field was set...

  1. Evaluation of the Efficacy of a Dental Plaque Control Program in Autistic Patients

    ERIC Educational Resources Information Center

    Dias, Guilherme G.; Prado, Eliane F. G. B.; Vadasz, Estevao; Siqueira, Jose Tadeu T.

    2010-01-01

    The aim of this study was to verify the efficacy of a programme for dental plaque control in autistics. Patients were evaluated on five occasions over a period of 180 days using the following instruments: OHI-S, DMF-T, the Fonnes brushing technique and diet questionnaire. Participants were divided into two groups according to level of co-operation…

  2. Biomarker Evaluation Does Not Confirm Efficacy of Computer-Tailored Nutrition Education

    ERIC Educational Resources Information Center

    Kroeze, Willemieke; Dagnelie, Pieter C.; Heymans, Martijn W.; Oenema, Anke; Brug, Johannes

    2011-01-01

    Objective: To evaluate the efficacy of computer-tailored nutrition education with objective outcome measures. Design: A 3-group randomized, controlled trial with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam. Participants: A convenience sample of healthy Dutch adults (n = 442).…

  3. Core Self-Evaluations, Career Decision Self-Efficacy, and Vocational Identity among Greek Adolescents

    ERIC Educational Resources Information Center

    Koumoundourou, Georgia A.; Kounenou, Kalliopi; Siavara, Eftyxia

    2012-01-01

    This study explored the mediating role of career decision self-efficacy between core self-evaluations (CSE), a newly established construct within the personality domain, and adolescents' vocational identity. Using a sample of 200 Greek high school students, it was found that for female adolescents CSE influenced vocational identity both directly…

  4. Self-Efficacy, Self-Evaluation, and Music Performance of Secondary-Level Band Students

    ERIC Educational Resources Information Center

    Hewitt, Michael P.

    2015-01-01

    In the present study, relationships between two components of self-regulation (self-efficacy and self-evaluation) and gender, school level, instrument family, and music performance were examined. Participants were 340 middle and high school band students who participated in one of two summer music camps or who were members of a private middle…

  5. Biomarker Evaluation Does Not Confirm Efficacy of Computer-Tailored Nutrition Education

    ERIC Educational Resources Information Center

    Kroeze, Willemieke; Dagnelie, Pieter C.; Heymans, Martijn W.; Oenema, Anke; Brug, Johannes

    2011-01-01

    Objective: To evaluate the efficacy of computer-tailored nutrition education with objective outcome measures. Design: A 3-group randomized, controlled trial with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam. Participants: A convenience sample of healthy Dutch adults (n = 442).…

  6. In vitro evaluation of the efficacy of a veterinary dry heat fluid warmer.

    PubMed

    Chiang, Vivian; Hopper, Kate; Mellema, Matthew S

    2011-12-01

    To evaluate the efficacy of a veterinary dry heat fluid warmer on ambient and prewarmed crystalloid fluids and refrigerated packed red blood cells (pRBC). Prospective in vitro study. University teaching hospital. None. Ambient and prewarmed crystalloid fluids and refrigerated pRBC were delivered via a standard fluid administration set at various rates. A thermistor continuously monitored fluid outflow temperature with and without a dry heat veterinary fluid warmer (study device). The outflow temperature was significantly higher with the study device as compared to control conditions for all fluids and rates tested. The maximum outflow temperature of approximately 35°C (95°F) occurred when the study device was applied to either ambient or prewarmed crystalloid fluids at 50 mL/h. In the study device trials, the outflow temperature of ambient crystalloid fluids ranged from 35.1° to 27.3°C (95.2° to 81.1°F) as the fluid rate increased from 50 to 999 mL/h. Control trials of prewarmed crystalloids produced outflow temperatures that rapidly approached ambient temperature. Addition of the study device to prewarmed crystalloids resulted in outflow temperatures that were similar to that of the corresponding ambient crystalloid trials. Control trials of refrigerated pRBC achieved ambient temperature at rates from 10 to 500 mL/h. With the study device, pRBC were maximally warmed to an outflow temperature of 35.8°C (96.4°F) at 100 mL/h. Although the study device generated statistically significant increases in outflow temperature of crystalloid fluids and pRBC, the ability of the device to decrease the metabolic cost of fluid administration is limited to specific clinical scenarios. The use of prewarmed crystalloid fluids with or without the study device offers minimal benefit over ambient temperature crystalloids. Substantial warming of pRBC occurs during administration, even without use of the study device. © Veterinary Emergency and Critical Care Society 2011.

  7. Glove Perforation Rate in Surgery: A Randomized, Controlled Study To Evaluate the Efficacy of Double Gloving.

    PubMed

    Makama, Jerry Godfrey; Okeme, Ibrahim Mohammed; Makama, Elizabeth Jerry; Ameh, Emmanuel Adoyi

    2016-08-01

    The risk of exposure of either the patient or the surgeon to communicable disease when the surgical glove is perforated is important. Both patients and the surgical team need to be protected from this risk. Therefore, we intended to determine the efficacy of double gloving in our center. This was a prospective cohort study, involving (randomly selected) surgeons, who wore single or double latex surgical gloves during procedures. Gloves were collected and evaluated for perforations (using air insufflation and water leak methods). A total of 1,536 gloves were collected (512 single gloves and 1,024 double gloves), with 78 of 512 gloves perforated, giving a rate of 15.2%. Perforation rate was 15.2% in single gloves, 14.4% in double gloves, 15.5% in emergency operations, and 14.3% in elective surgery. It was highest (30.8%) among registrars in training, particularly when doing any deep (16.0%) surgery. Glove perforation rate was highest (17.4%) among general surgery procedures as opposed to pediatric surgery (14.6%), urology (13.9%), neurosurgery (11.7%), and plastic surgery (10.6%), with (42.1%) index finger injury. In unused (control group) gloves, the rate of perforation was (0.8%). There was a substantial difference in the overall perforation rate between single and double glove sets (15.2% versus 14.4%) (X(2) = 1748, p < 0.0001). However, among the double set, total gloves [outer and inner set] analysis revealed a perforation rate of 27.5% (141 of 512). Of this set, the number of inner gloves that perforated as a result of a through and through puncture from outer to the inner gloves gave a rate of 1.17% (six of 512). Thus, the protection offered by double gloves was 98.83% (X(2) = 280.9, p < 0.0001) even if the outer gloves were perforated. The use of double gloves has more than 90% protection to patient and the surgeon. Therefore, wearing double gloves should be encouraged in surgery.

  8. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study

    PubMed Central

    Leali, Paolo Tranquilli; Solla, Federico; Maestretti, Gianluca; Balsano, Massimo; Doria, Carlo

    2016-01-01

    Summary Background Vertebral compression fractures (VCFs) treated non-operatively can diminish function and quality of life, and lead to chronic health effects. The short-term safety and effectiveness of vertebroplasty for symptomatic VCFs are well-documented, but long-term follow-up is needed. Purpose The aim of this paper was to analyse a multicenter international experience of 200 compression fractures treated with percutaneous vertebroplasty (VP) and compare the results of this procedure with the result of 200 patients treated conservatively. To estimate cost-effectiveness of VP compared to conservative care in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. Materials and methods 400 patients have been enrolled in a prospective randomized controlled study with painful VCFs with bone edema on MR imaging, local back pain for 6 weeks or less, osteoporosis and aged 55 years or older; after obtaining informed consent patients are included and randomized for VP or conservative care. Before treatment and at follow-up with regular intervals during 1-year period were administered to patients standard questionnaires addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score for pain, Oswestry Disability Index (ODI) score to evaluate functional activity. Results 200 patients treated with PV compared with 200 patients treated conservatively had significantly better VAS and used less analgesics 1 day after treatment. Twenty-four hours after VP, there was a reduction in pain scores and an improvement in physical functions, whereas remain unchanged in the patients treated conservatively. Conclusions Pain relief and improvement of mobility and function after PV is immediate and significantly better in the short term compared with non-surgical care treatment. PMID:28228788

  9. Relation Between Subacromial Bursitis on Ultrasonography and Efficacy of Subacromial Corticosteroid Injection in Rotator Cuff Disease: A Prospective Comparison Study.

    PubMed

    Lee, Doo-Hyung; Hong, Ji Yeon; Lee, Michael Young; Kwack, Kyu-Sung; Yoon, Seung-Hyun

    2017-05-01

    To evaluate the correlations between subacromial bursitis (bursal thickening and effusion) on ultrasonography and its response to subacromial corticosteroid injection in patients with rotator cuff disease. Prospective, longitudinal comparison study. University-affiliated tertiary care hospital. Patients with rotator cuff disease (N=69) were classified into 3 groups based on ultrasonographic findings; (1) normative bursa group (group 1, n=23): bursa and effusion thickness <1mm; (2) bursa thickening group (group 2, n=22): bursa thickness >2mm and effusion thickness <1mm; and (3) bursa effusion group (group 3, n=24): bursa thickness <1mm and effusion thickness >2mm. A single subacromial injection with 20mg of triamcinolone acetonide. Visual analog scale (VAS) of shoulder pain, Shoulder Disability Questionnaire (SDQ), angles of active shoulder range of motion (flexion, abduction, external rotation, and internal rotation), and bursa and effusion thickness at pre- and posttreatment at week 8. There were no significant differences between the 3 groups in demographic characteristics pretreatment. Groups 2 and 3 showed a significant difference compared with group 1 in changes on the VAS and abduction; group 3 showed a significant difference compared with group 1 in changes of the SDQ, internal rotation, and external rotation; and all groups showed significant differences when compared with each other (groups 1 and 3, 2 and 3, and 1 and 2) in changes of thickness. A patient with ultrasonographic observation of subacromial bursitis, instead of normative bursa, can expect better outcome with subacromial corticosteroid injection. Therefore, we recommend a careful selection of patients using ultrasonography prior to injection. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  10. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery

    PubMed Central

    2010-01-01

    Background A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery. Methods Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study. Results The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event. Conclusion This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery. Trial Registration ClinicalTrials.gov NCT01244165 PMID:21144043

  11. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery.

    PubMed

    Goldstein, Howard B; Maccarone, Joseph; Naughton, Martin J; Aguirre, Oscar A; Patel, Rakesh C

    2010-12-13

    A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery. Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study. The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event. This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery. ClinicalTrials.gov NCT01244165.

  12. Efficacy and safety of rapid escalation of cabergoline in comparison to conventional regimen for macroprolactinoma: A prospective, randomized trial

    PubMed Central

    Rastogi, Ashu; Walia, Rama; Dutta, Pinaki; Bhansali, Anil

    2012-01-01

    Introduction: Cabergoline (CAB) is conventionally started at a dose of 0.25-0.5 mg once a week with dose escalation at 1to 3months intervals. Previously, we and others have shown that rapid escalation and high doses of CAB can lead to normalization of serum PRL as early as 8.2 weeks in 93% of the patients. We hypothesize that rapid escalation of CAB doses, may help in both the earlier normalization of PRL and also significant shrinkage of tumor mass. Study Design: Randomized, prospective, interventional trial. Subjects and Methods: Forty two patients (male or female) with macroprolactinoma were randomized to conventional (group A) or rapid escalation (group B) of CAB dosing. In group B, CAB was started at a dose of 0.5 mg twice a week followed by a weekly hike of 1 mg/week, based on serum PRL and then monthly. The end point of the present study was a composite of normoprolactinemia and tumor shrinkage ≥50% from baseline. PRL and visual field analysis (weekly), other hormonal work up periodically and magnetic resonance imaging (sella) was performed monthly. Results: A total of 19 patients in each group completed a minimum follow-up of 6 months. There was a reduction of 72.7 ± 26.2% in group A and 84.1 ± 15.0 in group B (P = 0.24) within a week of CAB therapy. The duration of CAB treatment to normalize PRL was 10.2 ± 9.2 week(2-36) in group A and 7.2 ± 6.2 weeks(1-24) in group B (P = 0.28). There was no difference in the tumor shrinkage in either of the groups (92.3% [46.7-100%] in group A and 90.5% [66.6-100%] reduction in group B). The composite end point was achieved in 14 patients in group A (73.6%) and 16 patients in group B (84.2%) (P = 0.69). The composite end point was achieved in 13.1 ± 9.5 weeks (group A) versus 16.5 ± 14.1 weeks (group B) (P = 0.61). Discussion: This is first head to head comparative trial showing that a rapid hike of CAB dose is not associated with earlier normalization of PRL or reduction in tumor volume as compared to

  13. A prospective evaluation of the ligation of the intersphincteric tract procedure for complex anal fistula in patients with Crohn's disease.

    PubMed

    Gingold, Daniel S; Murrell, Zuri A; Fleshner, Phillip R

    2014-12-01

    To evaluate 2- and 12-month outcomes after ligation of the intersphincteric fistula tract (LIFT) in Crohn's disease (CD). Surgical approaches to perianal fistulas in CD are frequently ineffective and hampered by concerns over adequate wound healing and sphincter injury. The efficacy of LIFT in CD patients is unknown. Consecutive cases of CD patients with transsphincteric fistulas were prospectively analyzed. Fistula healing and 2 validated quality-of-life indices were assessed. Fifteen CD patients (9 women; mean age = 34.8 years) were identified. Location of the fistula was lateral (n = 10; 67%) or midline (n = 5; 33%). LIFT site healing was seen in 9 patients (60%) at 2-month follow-up. No patient developed fecal incontinence. LIFT site healing was seen in 8 of the 12 patients (67%) with complete 12-month follow-up. Significant factors for long-term LIFT site healing were lateral versus midline location (P = 0.02) and longer mean fistula length (P = 0.02). Patients who had successful operations significantly improved both their mean Wexner Perianal Crohn's Disease Activity Index and McMaster Perianal Crohn's Disease Activity Index quality-of-life scores at 2-month follow-up (14.0-3.8, P = 0.001, and 10.4-1.8, P = 0.0001, respectively). CD-associated anal fistulas may be treated with LIFT. This surgical procedure is a safe, outpatient procedure that minimizes both perianal wound creation and sphincter injury.

  14. 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

  15. A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain.

    PubMed

    Garvey, T A; Marks, M R; Wiesel, S W

    1989-09-01

    The efficacy of trigger-point injection therapy in treatment of low-back strain was evaluated in a prospective, randomized, double-blind study. The patient population consisted of 63 individuals with low-back strain. Patients with this diagnosis had nonradiating low-back pain, normal neurologic examination, absence of tension signs, and lumbosacral roentgenograms interpreted as being within normal limits. They were treated conservatively for 4 weeks before entering the study. Injection therapy was of four different types: lidocaine, lidocaine combined with a steroid, acupuncture, and vapocoolant spray with acupressure. Results indicated that therapy without injected medication (63% improvement rate) was at least as effective as therapy with drug injection (42% improvement rate), at a P value of 0.09. Trigger-point therapy seems to be a useful adjunct in treatment of low-back strain. The injected substance apparently is not the critical factor, since direct mechanical stimulus to the trigger-point seems to give symptomatic relief equal to that of treatment with various types of injected medication.

  16. [Impact on evaluation of clinical efficacy of traditional Chinese medicine for level in soft targets of processing technology].

    PubMed

    Shao, Ming-Yi; Wei, Ming; Yan, Bo-Hua

    2014-04-01

    Traditional Chinese medicine (TCM) is a very practical subject, which has its unique theoretical system and clinical characteristics. In the course of clinical practice, the exact clinical efficacy is the key of existence and development. But the existing evaluation system is difficult to objectively evaluate the clinical efficacy of TCM. Therefore, how to objectively evaluate the clinical efficacy and get definitive evidence is the focus of the evaluation of clinical efficacy of TCM. Relative to modern medicine, TCM is more concerned about the changes of feelings and clinical symptoms of the patient in the course of the evolution of the disease. Soft targets mainly used for the evaluation of the clinical efficacy of symptoms and functional activity of the disease. The level in soft targets of processing technology is often used methods in clinical evaluation. But it has often produced the phenomenon which the results of the evaluation is mutual contradiction, which will ultimately affect the effect of evaluation of clinical efficacy of TCM. In order to better evaluate the clinical efficacy of TCM, in the process of adoption of soft targets, it clearly identify it's role, highlighting the characteristics of interventions on disease, and as much as possibly avoid the level in soft targets of processing technology to real assess clinical efficacy of TCM.

  17. Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

    PubMed

    Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

    2016-12-01

    The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

  18. Evaluation of breast cancer chemotherapy efficacy with multifractal spectrum analysis of magnetic resonance image.

    PubMed

    Li, Li; Hu, Wen-yong; Liu, Li-zhi; Pang, Ya-chun; Shao, Yuan-zhi

    2014-01-01

    Multifractal spectrum analysis of dynamic contrast enhanced (DCE) breast MR images was used to establish a new quantitative analysis method for solid tumor blood perfusion and to explore its applicability in evaluating efficacy of breast cancer chemotherapy. Five randomly selected patients suffering from newly diagnosed malignant breast nodule lesions were enrolled in this study, and four of them were treated with neoadjuvant chemotherapy. Their DCE breast MR images were collected before and after treatment. Chemotherapeutic efficacy was analyzed using international response evaluation criteria for solid tumors (RECIST). Sandbox method for statistical number density was employed to measure and calculate multifractal spectra of DCE breast MR images with spatiotemporal characteristics. Multifractal spectral data of malignant lesions before and after chemotherapy were compared. Multifractal spectra of malignant lesions show an asymmetric bell-shape. Chemotherapy efficacy was assessed to be partial remission (PR) for three patients and their multifractal spectral width significantly increased after chemotherapy while to be stable disease (SD) for other patient and of her changed slightly. Multifractal spectral width correlates with blood-supply condition of tumor lesion before and after chemotherapy, providing a potential suitable characteristic parameter for evaluating chemotherapeutic efficacy quantitatively.

  19. Do medical students and young physicians assess reliably their self-efficacy regarding communication skills? A prospective study from end of medical school until end of internship.

    PubMed

    Gude, Tore; Finset, Arnstein; Anvik, Tor; Bærheim, Anders; Fasmer, Ole Bernt; Grimstad, Hilde; Vaglum, Per

    2017-06-30

    This prospective study from end of medical school through internship investigates the course and possible change of self- reported self-efficacy in communication skills compared with observers' ratings of such skills in consultations with simulated patients. Sixty-two medical students (43 females) from four Norwegian universities performed a videotaped consultation with a simulated patient immediately before medical school graduation (T1) and after internship (internal medicine, surgery and family medicine, half a year each - T2). Before each consultation, the participants assessed their general self-efficacy in communication skills. Trained observers scored the videos and applied a well-validated instrument to rate the communication behaviour. Results from the two assessment methods were correlated at both time points and possible differences from T1 to T2 were explored. A close to zero correlation between self-efficacy and observed communication skills were found at T1. At T2, participants' self-efficacy scores were inversely correlated with levels of observed skills, demonstrating a lack of concordance between young physicians' own assessment of self-efficacy and observers' assessment. When dividing the sample in three groups based on the observers' scores (low <1/3-, medium 1/3 to 2/3-, high competence >2/3), the group of male physicians showed higher levels of self-efficacy than females in all the three performance groups at T1. At T2, those having a high performance score yielded a low self-efficacy, regardless of gender. The lack of positive correlations between self-efficacy assessment and expert ratings points to limitations in the applicability of self-assessment measures of communication skills. Due to gender differences, groups of female and male physicians should be investigated separately. Those obtaining high-performance ratings from observers, through the period of internship, may become more conscious of how demanding clinical communication with

  20. The efficacy of oblique subcostal transversus abdominis plane block in laparoscopic cholecystectomy – a prospective, placebo controlled study

    PubMed Central

    Breazu, Caius Mihai; Ciobanu, Lidia; Hadade, Adina; Bartos, Adrian; Mitre, Călin; Mircea, Petru Adrian; Ionescu, Daniela

    2016-01-01

    Introduction Pain control after a laparoscopic cholecystectomy can represent a challenge, considering the side effects due to standard analgesia methods. Recently the transversus abdominis plane block (TAP Block) has been used as a part of multimodal analgesia with promising results. The subcostal approach (OSTAP Block), a variant on the TAP block, produces reliable unilateral supraumbilical analgesia. This study evaluated the efficacy of the OSTAP block with bupivacaine in laparoscopic cholecystectomy compared with the placebo OSTAP block. Material and Methods Sixty ASA I/II adult patients listed for elective laparoscopic cholecystectomy were randomly allocated in one of two groups: Group A (OSTAP placebo) received preoperatively bilateral OSTAP block with sterile normal saline and Group B (OSTAP bupivacaine) received bilateral preoperatively OSTAP block with the same volumes of 0.25% bupivacaine. Twenty-four hours postoperative opioid consumption, the dose of opioid required during surgery, opioid dose in the recovery unit (PACU) and PACU length of stay were evaluated. The quality of analgesia was assessed by the Visual Analogue Scale (VAS) at specific interval hours during 24 h, at rest and with movement. Results The mean intraoperative opioid consumption showed a significant difference between the two groups, (385 ± 72.52 mg in group A vs 173.67 ± 48.60 mg in group B, p < 0.001). The mean 24 h opioid consumption showed a statistically significant difference between groups (32 ± 26.05 mg vs 79 ± 16.68 mg, p < 0.001). PACU length of stay was significantly lower for group B patients compared with group A patients (20.67 ± 11.27 min vs 41.67 ± 12.41 min, p < 0.001). The OSTAP bupivacaine group had a statistically significant lower pain score than the OSTAP placebo group at 0, 2, 4, 6, 12, 24 h, both at rest and with movement. No signs or symptoms of local anaesthetic systemic toxicity or other complications were detected. Conclusion OSTAP block with

  1. Searching for control: priming randomness increases the evaluation of ritual efficacy.

    PubMed

    Legare, Cristine H; Souza, André L

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual action and a desired outcome. Two experiments were conducted (one in Brazil [n = 40] and another in the United States [n = 94]) to evaluate how the perceived efficacy of rituals is affected by feelings of randomness. In a between-subjects design, the Scramble Sentence Task was used as a priming procedure in three conditions (i.e., randomness, negativity, and neutral) and participants were then asked to rate the efficacy of rituals used for problem-solving purposes. The results demonstrate that priming randomness increased participants' perception of ritual efficacy relative to negativity and neutral conditions. Implications for increasing our understanding of the relationship between perceived control and ritualistic behavior are discussed.

  2. Using Self-Efficacy as a Construct for Evaluating Science and Mathematics Methods Courses

    NASA Astrophysics Data System (ADS)

    Brand, Brenda R.; Wilkins, Jesse L. M.

    2007-04-01

    The focus of this study was elementary preservice teachers’ development as effective teachers of science and mathematics as influenced by their participation in elementary science and mathematics methods courses. Preservice teachers’ reports of factors that influenced their perception of their teaching abilities were analyzed according to Bandura’s (1994) 4 sources of efficacy: mastery experiences, vicarious experiences, social persuasion, and stress reduction. This investigation allowed the researchers to evaluate the courses based on these sources. The analysis indicated all 4 sources influenced preservice teachers’ teaching self-efficacy beliefs, with mastery experiences considered the most influential. Embedded within discussions of mastery experiences were references to the other sources of efficacy, which suggest an interrelationship between mastery experiences and the other sources.

  3. Evaluation of Efficacy of Intraligamentary Injection Technique for Extraction of Mandibular Teeth-A Prospective Study

    PubMed Central

    Pradhan, Raunak; Kulkarni, Deepak

    2017-01-01

    Introduction Fear of dental pain is one of the most common reasons for delaying dental treatment. Local Anaesthesia (LA) is the most commonly employed technique of achieving pain control in dentistry. Pterygomandibular Nerve Block (PNB), for achieving mandibular anaesthesia has been the traditional technique used and is associated with a few set of complications which include pain, nerve injury, trismus, and rarely facial nerve palsy, and sustained soft tissue anaesthesia. These complications have resulted in a rapid need for research on alternative local anaesthetic techniques. Aim This study was undertaken with the objective to determine pain, duration, profoundness and complications associated with administration of Intraligamentary Injection Technique (ILT). Materials and Methods This study was conducted on 194 patients (male=122, female=72) who reported for dental extractions in mandibular posteriors. The ILT was administered with ligajet intraligamentary jet injector using cartridge containing lignocaine hydrochloride 2% with adrenaline 1:80000 and a 30 gauge needle at buccal (mesiobuccal), lingual, mesial and distal aspect of the mandibular molars. The data was analyzed by using statistical computer software SPSS 11.0 (Statistical package for social sciences 11.O version of SPSS Inc.). Median was derived for Pain on Injection (PI) and Pain during Procedure (PP). Mean and standard deviation was derived for Duration of Anaesthesia (DA). Results Various advantages were seen such as, localized soft tissue anaesthesia, decreased PI (SD=0.83), and minimal PP (SD=0.94). The DA (SD=4.62) and mean value of 24.06 minutes. Conclusion This study is one of its kinds where intraligamentary injection has been used for extraction of mandibular molars. It was also successfully used in patients with exaggerated gag reflex and patients suffering from trismus due to oral submucous fibrosis. The intraligamentary injection technique can thus be used effectively to anaesthetize mandibular molars, as a primary technique for extraction of mandibular posterior teeth. PMID:28274058

  4. The application of nursing-sensitive quality indicators in evaluating nursing efficacy.

    PubMed

    Li, Zhiying; Cheng, Shouzheng; Lv, Linhua; She, Xi yun; Liu, Xiao Hong

    2014-01-01

    To investigate the application of nursing-sensitive quality indicators in evaluating nursing efficacy. The study involved the 97 nursing units of four general hospitals, where quality-improvement projects were implemented. The efficacy of the projects was measured through the use of nursing-sensitive quality indicators followed by a Plan-Do-Study-Act cycle. Nursing efficacy was observed before and after the implementation. Indicators revealed that patient satisfaction with basic nursing care, professional skills, and service attitude increased significantly after implementation of the quality-improvement projects (p<0.05). The incidence of nursing adverse events, including deficient care and accidents, also decreased significantly (p<0.01). However, patient satisfaction with the medical environment did not increase. Nursing-sensitive quality indicators are a valid and reliable way to determine if nursing quality-improvement projects are efficacious. They also promote continual improvement in nursing quality and provide a scientific evidence for setting implementation plan and detecting the implementation efficacy in nursing care, and possess certain promoting effects on the continual improvement of nursing quality.

  5. Psychometric evaluation of the Marijuana Reduction Strategies Self-Efficacy Scale with young recreational marijuana users.

    PubMed

    Davis, Alan K; Osborn, Lawrence A; Rosenberg, Harold; Cross, Nicole; Lauritsen, Kirstin J; Ashrafioun, Lisham; Bradbury, Stacey; Feuille, Margaret; Lackey, Jennifer H; Hawley, Anna; Leith, Jaclyn

    2014-12-01

    This study evaluated the cue-reactivity and several psychometric properties of a questionnaire designed to assess marijuana users' self-efficacy to employ 21 specific cognitive-behavioral strategies to reduce their marijuana use. Using a web-based recruitment and data-collection procedure, 513 regular marijuana users completed dependent measures following marijuana-related or control cue exposure. Although exposure to marijuana-related stimuli significantly increased reported craving, mean reduction-strategy self-efficacy scores did not differ as a function of cue exposure. Reliability analyses supported retaining all 21 items as a single scale. Reduction-strategy self-efficacy was positively associated with marijuana-refusal self-efficacy and with recent past use of reduction strategies, was negatively associated with quantity and frequency of marijuana use and marijuana-related problems, and was positively but weakly associated with general self-efficacy. The most frequently reported strategies that were employed reflected restricting marijuana use to once per day, not keeping a large stash available, turning down unwanted hits, and not obtaining more marijuana right away if one's supply runs out. These findings further support the reliability and validity of the questionnaire when administered to a diverse sample of regular marijuana users. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Evaluation of the efficacy and safety of etoricoxib in the treatment of hemophilic arthropathy.

    PubMed

    Tsoukas, Christos; Eyster, M Elaine; Shingo, Sumiko; Mukhopadhyay, Saurabh; Giallella, Karen M; Curtis, Sean P; Reicin, Alise S; Melian, Agustin

    2006-03-01

    This 2-part, double-blind, placebo-controlled study was conducted to determine the safety and efficacy of etoricoxib, a COX-2 selective inhibitor, for the treatment of hemophilic arthropathy. In part 1 (6 weeks), 102 patients (> or = 12 years old) with hemophilic arthropathy were randomized to receive 90 mg etoricoxib once daily or placebo (1:1 ratio). In part 2 (6 months), 51 patients taking placebo in part 1 were randomized to receive 90 mg etoricoxib or 25 mg rofecoxib once daily; patients taking etoricoxib in part 1 continued the same treatment. Efficacy end points included Patient Assessment of Arthropathy Pain, Patient Global Assessment of Arthropathy Disease Status, and Investigator Global Assessment of Arthropathy Disease Status. Safety was evaluated at each study visit. Etoricoxib provided significant improvement in all end points versus placebo (P < .001). Fewer patients taking etoricoxib discontinued due to a lack of efficacy versus placebo (P = .048). During part 2, efficacy was maintained; etoricoxib and rofecoxib demonstrated similar results. The most common adverse experiences were upper respiratory infection and headache. The incidence of joint bleeding during part 1 was similar between etoricoxib (66.7%) and placebo (72.6%) and during part 2 between etoricoxib (77.0%) and rofecoxib (78.9%). We conclude that etoricoxib provided superior efficacy versus placebo for the treatment of hemophilic arthropathy and was generally safe and well tolerated.

  7. Efficacy of narrowband ultraviolet B phototherapy and levels of serum vitamin D3 in psoriasis: A prospective study

    PubMed Central

    Gupta, Aditi; Arora, Trilok Chand; Jindal, Ankur; Bhadoria, Ajeet Singh

    2016-01-01

    Introduction: Narrowband ultraviolet B phototherapy (NBUVB) is safe and effective treatment for psoriasis. Vitamin D plays an important role in pathogenesis of psoriasis. It is known that psoriasis patients have low serum 25(OH)D levels, which increase after NBUVB. We assessed serum 25(OH)D levels, its correlation with Psoriasis Area and Severity Index (PASI), and the effect of NBUVB on 25(OH)D levels among Indian psoriasis patients. Materials and Methods: A prospective study comprising 30 adults with psoriasis with no major comorbidities (PASI > 10 and off-therapy >4 weeks) was conducted. PASI was estimated at baseline among patients and repeated after receiving 12 weeks of NBUVB therapy. Thirty age and gender-matched healthy controls were recruited to compare 25(OH)D levels at baseline and at 12 weeks. Patient demographic parameters, treatment dose, duration, side effects, and its impact on 25(OH)D levels and PASI were serially evaluated. Results: A total of 30 patients presenting with psoriasis and 30 healthy controls were enrolled in the study. Mean baseline PASI (M: F =19:11) among patients with mean age 36.8 (±7.7) years was 20.5 (±6.3) and all patients were either 25(OH)D deficient (n = 14) or insufficient (n = 16). Their baseline 25(OH)D levels were significantly lower than controls (25.93 nmol/L vs 47.54 nmol/L; P < 0.001). After NBUVB therapy (average cumulative dose 20.76 ± 7.1 J/cm2; average treatment sessions 32.57 ± 1.9), there was a significant improvement in PASI as well as 25(OH)D (P < 0.05). There was no correlation between the mean improvement in PASI and 25(OH)D after 12 weeks of therapy. Twelve (40%) patients had therapy-related side effects [pruritus (n = 8), erythema (n = 4)], none had major side effects. Conclusion: Improvement in PASI and serum 25(OH)D levels after NBUVB in psoriasis is significant but poorly correlated with each other. Vitamin D may not be the lone mediator of the therapeutic effects of NBUVB on psoriasis. PMID

  8. A prospective examination of exercise and barrier self-efficacy to engage in leisure-time physical activity during pregnancy.

    PubMed

    Cramp, Anita G; Bray, Steven R

    2009-06-01

    Pregnant women without medical contraindications should accumulate 30 min of moderate exercise on most days of the week, yet many pregnant women do not exercise at recommended levels. The purpose the study was to examine barriers to leisure-time physical activity (LTPA) and investigate barrier and exercise self-efficacy as predictors of self-reported LTPA during pregnancy. Pregnant women (n = 160) completed questionnaires eliciting barriers to LTPA, measures of exercise and barrier self-efficacy, and 6-week LTPA recall at gestational weeks 18, 24, 30, and 36. A total of 1,168 barriers were content-analyzed, yielding nine major themes including fatigue, time constraints, and physical limitations. Exercise self-efficacy predicted LTPA from gestational weeks 18 to 24 (beta = 0.32, R(2) = 0.26) and weeks 30 to 36 (beta = 0.41, R(2) = 0.37), while barrier self-efficacy predicted LTPA from weeks 24 to 30 (beta = 0.40, R(2) = 0.32). Pregnant women face numerous barriers to LTPA during pregnancy, the nature of which may change substantially over the course of pregnancy. Higher levels of self-efficacy to exercise and to overcome exercise barriers are associated with greater LTPA during pregnancy. Research and interventions to understand and promote LTPA during pregnancy should explore the dynamic nature of exercise barriers and foster women's confidence to overcome physical activity barriers.

  9. Prospective nailfold capillaroscopy evaluation of Raynaud's phenomenon in children and adolescents.

    PubMed

    Piotto, Daniela G P; Hilário, Maria O E; Carvalho, Natalia S; Len, Cláudio A; Andrade, Luis E C; Terreri, Maria T R A

    2013-01-01

    To evaluate prospectively the clinical features and nailfold capillaroscopy findings of a cohort of children and adolescents who presented Raynaud's phenomenon (RP) without criteria for autoimmune rheumatic diseases. 40 children and adolescents with isolated RP were included. Evidence of systemic autoimmune rheumatic diseases (SARD) was ruled out by thorough clinical and laboratory examination. Concomitantly we also performed wide-field nailfold capillaroscopy evaluation using an optical microscope with magnifications of 10 and 16X. All patients were prospectively re-evaluated within a mean interval time between evaluations of 1.6 years. Thirty (75%) out of 40 patients were female with a mean age of 14.6 years and mean follow-up time of 4.2 years. The mean age of disease onset was 10.4 years and the mean time until diagnosis was 1.4 years. Fourteen out of 40 patients (35%) presented antinuclear antibodies (ANA). Five (12.5%) patients had altered nailfold capillaroscopy at first examination: four presented non-specific microangiopathy and one presented scleroderma pattern. At the re-evaluation three patients (7.5%) presented nailfold capillaroscopy alterations (two SD pattern and one non-specific microangiopathy). The two patients who showed scleroderma pattern at the nailfold capillaroscopy presented along the follow-up a diagnosis of mixed connective tissue disease and hypothyroidism, respectively. One 10 year-old girl with normal nailfold capillaroscopy and presence of autoantibodies (ANA 1/640, nuclear homogeneous pattern, anti-native DNA 1/80) was diagnosed with systemic lupus erythematosus after 1 year of initial evaluation. None of the other children presented diagnosis of SARD along the follow-up. Primary Raynaud´s phenomenon remained the diagnosis in most cases in this series of children and adolescents presenting with initial RP complaint. Nailfold capillaroscopy and determination of autoantibodies were useful ancillary tools in the investigation of

  10. A prospective, multicentre study to investigate the efficacy, safety and tolerability of octreotide LAR® (long-acting repeatable octreotide) in the primary therapy of patients with acromegaly

    PubMed Central

    Mercado, Moises; Borges, Fatima; Bouterfa, Hakim; Chang, Tien-Chun; Chervin, Alberto; Farrall, Andrew J; Patocs, Attila; Petersenn, Stephan; Podoba, Jan; Safari, Mitra; Wardlaw, Joanna

    2007-01-01

    Objective To evaluate the efficacy, safety and tolerability of octreotide LAR® (long-acting repeatable octreotide) in the primary therapy of acromegaly. Design and patients Ninety-eight previously untreated acromegalics were recruited into this prospective multicentre study. A total of 68 patients successfully completed 48 weeks of the study period, received 12 doses of octreotide LAR 10–30 mg every 4 weeks, and constituted the population used for this analysis. Measurements and results A clinically relevant reduction (i.e. to ≤ 5 µg/l) in mean GH (mGH) was recorded in 72% of patients after 24 weeks of treatment, and 42% reached a ‘safe’ GH value (≤ 2·5 µg/l). At week 48, 16 more patients were considered partial GH responders (GH > 2·5 µg/l and ≤ 5 µg/l) and 44% had reached a GH level ≤ 2·5 µg/l. IGF-1 levels normalized in 38% and 34% of patients after 24 and 48 weeks of treatment, respectively. At study completion, 10 patients (14·7%) who had not normalized their IGF-1 levels had achieved at least a 50% decrement in this marker. In eight microadenoma patients, tumour volume decreased from a mean baseline level of 298 ± 145 mm3 to 139 ± 94 mm3 after 24 weeks and to 99 ± 70 mm3 after 48 weeks of therapy. In 60 patients with macroadenoma, the corresponding values were 3885 ± 5077 mm3 at baseline and 2723 ± 3435 and 2406 ± 3207 mm3 after 24 and 48 weeks, respectively. At weeks 24 and 48, a significant (> 20%) tumour volume reduction was reported in 63% and 75% of patients, respectively. A reduction in the severity of symptoms of acromegaly was observed early in treatment and was maintained throughout the study period. Conclusion Octreotide LAR represents a viable alternative to surgery for primary treatment of acromegaly leading to a progressive regression of tumour volume, a sustained control of biochemical abnormalities and an adequate relief of symptoms of the disease. PMID:17465997

  11. Evaluation of the sterilization efficacy of domestic electric drills used in orthopaedic surgeries

    PubMed Central

    Goveia, Vania Regina; Pinto, Flavia Morais Gomes; Machoshvili, Irene Alexeevna; Penna, Thereza Christina Vessoni; Graziano, Kazuko Uchikawa

    2009-01-01

    It is estimated that electric drills (ED) have been used in orthopaedic surgeries for bone drilling for more than 50 years in Brazilian hospitals. It is an electric, thermosensitive equipment, not indicated for surgical use, which has not been previously evaluated regarding the sterilization efficacy, being suspect of infection risk. This study evaluated the efficacy of sterilization by ethylene oxide (EtO) of new drills that were intentionally contaminated with Bacillus atrophaeus spores. An experimental, laboratory, randomized applied research was developed, where 16 electric drills were analyzed, in addition to positive and negative controls. All the previously cleaned and sterilized equipment were submitted to contamination by spores. The experimental group was submitted to cleaning and sterilization by EtO and test of sterility by filtration through a 0.45 >m membrane. The membranes were cultivated and Gram and Wirtz-Conklin staining were carried out in positive results for spore visualization. An efficacy of 99.99999881% of the process of sterilization by EtO was confirmed, with a probability of survival of 1.19 x 10 -8. Under the development conditions of the experiment, the efficacy of the sterilization of ED by EtO was confirmed. PMID:24031397

  12. Development and evaluation of the Marijuana Reduction Strategies Self-Efficacy Scale.

    PubMed

    Davis, Alan K; Osborn, Lawrence A; Leith, Jaclyn; Rosenberg, Harold; Ashrafioun, Lisham; Hawley, Anna; Bannon, Erin E; Jesse, Samantha; Kraus, Shane; Kryszak, Elizabeth; Cross, Nicole; Carhart, Victoria; Baik, Kyoung-deok

    2014-06-01

    To evaluate several psychometric properties of a questionnaire designed to assess college students' self-efficacy to employ 21 cognitive-behavioral strategies intended to reduce the amount and/or frequency with which they consume marijuana, we recruited 273 marijuana-using students to rate their confidence that they could employ each of the strategies. Examination of frequency counts for each item, principal components analysis, internal consistency reliability, and mean interitem correlation supported retaining all 21 items in a single scale. In support of criterion validity, marijuana use-reduction self-efficacy scores were significantly positively correlated with cross-situational confidence to abstain from marijuana, and significantly negatively correlated with quantity and frequency of marijuana use and marijuana-related problems. In addition, compared with respondents whose use of marijuana either increased or remained stable, self-efficacy was significantly higher among those who had decreased their use of marijuana over the past year. This relatively short and easily administered questionnaire could be used to identify college students who have low self-efficacy to employ specific marijuana reduction strategies and as an outcome measure to evaluate educational and skill-training interventions.

  13. How flexible is coping after acquired brain injury? A 1-year prospective study investigating coping patterns and influence of self-efficacy, executive functioning and self-awareness.

    PubMed

    Brands, Ingrid; Köhler, Sebastian; Stapert, Sven; Wade, Derick; van Heugten, Caroline

    2014-10-01

    To investigate coping flexibility in patients with newly acquired brain injury and to investigate the influence of problem type, self-efficacy, self-awareness and self-reported executive functions on coping flexibility. Data were collected from a prospective clinical cohort study of 136 patients assessed after discharge home (mean time since injury = 15 weeks) and 1 year later. Situation-specific coping was measured by asking patients to complete the Coping Inventory for Stressful Situations (CISS) for 3 acquired brain injury (ABI)-related situations, which were then categorized into problem types (physical, cognitive, emotional, behavioural, communication, other). Coping consistency (number of strategies used throughout every situation) and variability (range in frequency of use of strategies over situations) were measured. Random effects regression analyses were used. Patients used more task-oriented coping for cognitive compared with physical problems. Coping variability was limited. Reliance on emotion-oriented coping decreased over time. Higher self-efficacy correlated with increased task-oriented and avoidance coping and decreased emotion-oriented coping. Greater self-reported problems in executive function correlated with greater consistency in task-oriented and emotion-oriented strategies. Patients with acquired brain injury rely on a defined set of coping options across situations and time. High self-efficacy increases active coping. Subjective executive dysfunction might hamper effective strategy selection.

  14. Data-Intensive Evaluation: The Concept, Methods, and Prospects of Higher Education Monitoring Evaluation

    ERIC Educational Resources Information Center

    Wang, Zhanjun; Qiao, Weifeng; Li, Jiangbo

    2016-01-01

    Higher education monitoring evaluation is a process that uses modern information technology to continually collect and deeply analyze relevant data, visually present the state of higher education, and provide an objective basis for value judgments and scientific decision making by diverse bodies Higher education monitoring evaluation is…

  15. Data-Intensive Evaluation: The Concept, Methods, and Prospects of Higher Education Monitoring Evaluation

    ERIC Educational Resources Information Center

    Wang, Zhanjun; Qiao, Weifeng; Li, Jiangbo

    2016-01-01

    Higher education monitoring evaluation is a process that uses modern information technology to continually collect and deeply analyze relevant data, visually present the state of higher education, and provide an objective basis for value judgments and scientific decision making by diverse bodies Higher education monitoring evaluation is…

  16. Evaluation of high-intensity focused ultrasound ablation for uterine fibroids: an IDEAL prospective exploration study.

    PubMed

    Chen, J; Li, Y; Wang, Z; McCulloch, P; Hu, L; Chen, W; Liu, G; Li, J; Lang, J

    2017-04-19

    To evaluate the clinical outcomes of high-intensity focused ultrasound (HIFU) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial. Prospective multicentre patient choice cohort study (IDEAL Exploratory study) of HIFU, myomectomy or hysterectomy for treating symptomatic uterine fibroids. 20 Chinese hospitals. 2411 Chinese women with symptomatic fibroids. Prospective non-randomised cohort study with learning curve analysis (IDEAL Stage 2b Prospective Exploration Study). Complications, hospital stay, return to normal activities, and quality of life (measured with UFS-Qol and SF-36 at baseline, 6 and 12 months), and need for further treatment. Quality-of-life outcomes were adjusted using regression modelling. HIFU treatment quality was evaluated using LC-CUSUM to identify operator learning curves. A health economic analysis of costs was performed. 1353 women received HIFU, 472 hysterectomy and 586 myomectomy. HIFU patients were significantly younger (P < 0.001), slimmer (P < 0.001), better educated (P < 0.001), and wealthier (P = 0.002) than surgery patients. Both UFS and QoL improved more rapidly after HIFU than after surgery (P = 0.002 and P = 0.001, respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of HIFU and in 133 (12.6%) of surgical cases (P < 0.001). Median time for hospital stay was 4 days (interquartile range, 0-5 days), 10 days (interquartile range, 8-12.5 days) and 8 days (interquartile range, 7-10 days). HIFU caused substantially less morbidity than surgery, with similar longer-term QoL. Despite group baseline differences and lack of blinding, these findings support the need for a randomised controlled trial (RCT) of HIFU treatment for fibroids. The IDEAL Exploratory design facilitated RCT protocol development. HIFU had much better short-term outcomes than surgery for fibroids in 2411-patient Chinese IDEAL format study. © 2017 Royal College of Obstetricians and

  17. The efficacy of an educational program for parents of children with epilepsy (FAMOSES): Results of a controlled multicenter evaluation study.

    PubMed

    Hagemann, Anne; Pfäfflin, Margarete; Nussbeck, Fridtjof W; May, Theodor W

    2016-11-01

    The objective of this study was to evaluate the efficacy of the educational program FAMOSES (modular service package epilepsy for families) for parents of children with epilepsy. Parents of children with epilepsy from Germany and Austria were included in a controlled prospective multicenter study using a pre-post design. Participants of the FAMOSES program (FAMOSES group, n=148) completed a standardized questionnaire immediately before the program and six months later. The matched control group of parents not participating in the program (n=74, matching ratio 2:1) also answered the questionnaire twice, at an interval of six months. The questionnaire comprised epilepsy-specific outcome measures (e.g., knowledge, coping, fears) and disease-related variables (e.g., seizure frequency). The generalized estimation equation approach was used for statistical analysis. In addition, parents' satisfaction with the FAMOSES program was assessed six months after participation. Parents of the FAMOSES group significantly improved in epilepsy-specific knowledge (group×time interaction: p<.001), coping (p<.01), epilepsy-related fears (p<.05), and in speaking about epilepsy with their child (p<.05) compared with the control group. No effects were found on disease-related variables. Nearly all of the participants rated the FAMOSES parents' program as "very good" (71%) or "good" (27%). The efficacy of the FAMOSES parents' program was confirmed. The results indicate that imparting knowledge and the interactive approach help parents in coping with their child's epilepsy and reduce epilepsy-related fears. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial

    PubMed Central

    Baumann, Petra; Schumacher, Hardy; Hüsing, Johannes; Luntz, Steffen; Knaebel, Hanns-Peter

    2009-01-01

    Background The development of suture hole bleeding at peripheral arterial bypass anastomoses using PTFE graft prostheses is a common problem in peripheral vascular surgery. Traditionally the problem is managed by compression with surgical swabs and reversal heparin or by using several haemostatic device (e.g. different forms of collagen, oxidized cellulose, gelatine sponge, ethylcyanoacrylate glue or fibrin) with various success. Preclinical data suggest that the haemostatic effect of collagen is stronger than that of oxidized cellulose, but no direct clinical comparison of their hemostatic performance has been published so far. Design This randomized, controlled, prospective trial evaluates the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis. 28 patients undergoing an elective peripheral vascular reconstruction due to peripheral vascular disease will be included. Suture hole bleeding occurring at the arterial bypass anastomosis using a PTFE prostheses will be stopped by the application of Lyostypt and/or Surgicel. The proximal anastomoses will be randomized intraoperatively. The patients will be allocated into 4 different treatment groups. Group1 Lyostypt distal/Surgicel proximal; Group 2: Lyostypt proximal/Surgicel distal; Group 3: Surgicel distal and proximal; Group 4: Lyostypt distal and proximal. Primary endpoint of the study is time to haemostasis. Secondary endpoints are the number of intraoperatively used haemostatic devices, postoperative mortality within 30 days as well as the intraoperative efficacy rating of the two devices evaluated by the surgeon. As a safety secondary parameter, the local and general complication occurring till 30 ± 10 days postoperatively will also be analysed. After hospital discharge the investigator will examine the enrolled patients again at 30 days after surgery. Discussion The COBBANA trial aims to assess, whether the haemostatic effect of Lyostypt is superior to Surgicel in suture hole bleedings

  19. Transdermal scopolamine in the prevention of motion sickness - Evaluation of the time course of efficacy

    NASA Technical Reports Server (NTRS)

    Homick, J. L.; Reschke, M. F.; Degioanni, J.; Cintron-Trevino, N. M.; Kohl, R. L.

    1983-01-01

    This study evaluated the time course of efficacy of transdermal scopolamine in the prevention of motion sickness induced by exposure to coriolis stimulation in a rotating chair. We measured levels of efficacy, quantified side effects and symptoms, and determined inter- and intra-subject variability following use of transdermal scopolamine. The response to transdermal scopolamine was highly variable, although overall we recorded a 40 percent improvement in test scores 16-72 h after application of the transdermal system. This variability could not be explained solely by the levels of scopolamine present in the blood. The improvement was not due to the artifactual repression by scopolamine of selected symptoms of motion sickness. An unexpectedly high incidence of side effects was reported. It was concluded that the therapeutic use of transdermal scopolamine be evaluated individually and that individuals be cautioned that subsequent usage may not always be effective.

  20. Transdermal scopolamine in the prevention of motion sickness - Evaluation of the time course of efficacy

    NASA Technical Reports Server (NTRS)

    Homick, J. L.; Reschke, M. F.; Degioanni, J.; Cintron-Trevino, N. M.; Kohl, R. L.

    1983-01-01

    This study evaluated the time course of efficacy of transdermal scopolamine in the prevention of motion sickness induced by exposure to coriolis stimulation in a rotating chair. We measured levels of efficacy, quantified side effects and symptoms, and determined inter- and intra-subject variability following use of transdermal scopolamine. The response to transdermal scopolamine was highly variable, although overall we recorded a 40 percent improvement in test scores 16-72 h after application of the transdermal system. This variability could not be explained solely by the levels of scopolamine present in the blood. The improvement was not due to the artifactual repression by scopolamine of selected symptoms of motion sickness. An unexpectedly high incidence of side effects was reported. It was concluded that the therapeutic use of transdermal scopolamine be evaluated individually and that individuals be cautioned that subsequent usage may not always be effective.

  1. Participant evaluations of rate and communication efficacy of an AAC application using natural language processing.

    PubMed

    Wisenburn, Bruce; Higginbotham, D Jeffery

    2009-06-01

    This research explores the efficacy of an AAC application, Converser, that uses natural language processing to assist in communication. Converser uses speech recognition of the speaking partner to predict contextually appropriate utterances. This article reports on the subjective data gathered from an experimental evaluation of Converser's efficacy (see Wisenburn and Higginbotham, 2008 for a full description of Converser and the objective results). Converser was evaluated in two communication tasks (a Conversation and an Interview task) under two conditions: a simple alphabet board without Converser (alpha-only condition), and an identical board with Converser (alpha-Converser condition). Subjective data was gathered through rating questionnaires and written comments. Program users rated the speed of communication faster in the alpha-Converser condition. Program user ratings of quality, and speaking partner ratings of speed and quality, showed no difference between the two conditions; however, the participant comments about Converser were positive.

  2. Self-Efficacy of Prospective Austrian and German Primary School Teachers Regarding the Implementation of Inclusive Education

    ERIC Educational Resources Information Center

    Schwab, Susanne; Hellmich, Frank; Görel, Gamze

    2017-01-01

    This study examined the psychometric properties of the German version of the Teacher Inclusive Education Self-Efficacy Scale (TIESES). Five hundred and nineteen teacher education students from Austria and 765 teacher education students from Germany participated in the study. Results of a multiple-group confirmatory factor analysis (for the two…

  3. EVALUATION OF THE EFFICACY AND SAFETY OF A NEW HERBAL REVITALIZER REVIVIN

    PubMed Central

    Rani, P. Usha; Naidu, M.U.R; Kumar, T Ramesh; Shobha, J.C

    1997-01-01

    Clinical efficacy and safety of a herbomineral drug containing withania somnifera Asparagus racemosus glycyrrhiza glabra, mucuna pruriens, Myristica fragrans, Anauchus pyrethrum, Ipomoea digitata, sida cordifolia, zine ash complex and high energy carbohydrate molecules were evaluated in an open study. All patients treated with the drug reported good improvement in the various symptomatology of general weakness appetite, sleep mood, and concentration the overall improvement ranged between 69-77% The drug was well tolerated. PMID:22556791

  4. Evaluating the Motivations, Knowledge, and Efficacy of Participants in Environmental Health Citizen Science Projects

    NASA Astrophysics Data System (ADS)

    Sandhaus, Shana

    Environmental research is increasingly using citizen scientists in many aspects of projects, such as data collection and question design. To date, only a limited number of co-created citizen science projects where community members are involved in most or all steps of the scientific process have been completed, and few comparing community engagement methods and efficacy and learning outcomes across demo- and geographic data. This study compares two citizen science programs, evaluating what motivates citizen scientists to participate in environmental health research and whether participation affects scientific knowledge and environmental behavior and efficacy. Participants in the Gardenroots: A Citizen Science Garden Project completed sample collection training and submitted soil, water, vegetable, and dust samples for analysis and received their environmental monitoring results. In the Facilitating Community Action to Address Climate Change and Build Resiliency in Southern Metropolitan Tucson project, Spanish speaking community members of South Tucson underwent training in climate change and environmental quality and sample collection, and worked with families in the South Tucson community, collecting soil and water samples and providing environmental health education. For both projects, participants completed a pre- and post-survey with a variety of qualitative and quantitative questions. These survey instruments were used to evaluate differences in environmental self-efficacy and motivations. In addition, select Gardenroots participants were involved in focus groups and semi-structured interviews to understand and gauge changes in knowledge and to further explore changes in motivation and self-efficacy. The participants were primarily internally motivated and saw increases in both efficacy and knowledge as a result of participation in the program. This information is critical to moving citizen science efforts forward and determining whether such projects: 1) co

  5. A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs

    PubMed Central

    Harman, Robert; Carlson, Kim; Gaynor, Jamie; Gustafson, Scott; Dhupa, Sarit; Clement, Keith; Hoelzler, Michael; McCarthy, Tim; Schwartz, Pamela; Adams, Cheryl

    2016-01-01

    Osteoarthritis (OA) is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells (MSCs) have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with OA. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM) and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived MSCs in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2 versus 55.4%, p = 0.029). The veterinary pain on manipulation score (92.8 versus 50.2%, p = 0.017) and the veterinary global score (86.9 versus 30.8%, p = 0.009) were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy. PMID:27695698

  6. Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study

    PubMed Central

    Kim, Sung-Hoon; Hong, Jeong-Yeon; Kim, Won Oak; Karm, Myong-Hwan; Hwang, Jai-Hyun

    2013-01-01

    Background Postoperative nausea and vomiting (PONV) continues to be a major problem, because PONV is associated with delayed recovery and prolonged hospital stay. Although the PONV guidelines recommended the use of 5-hydroxy-tryptamine (5-HT3) receptor antagonists as the first-line prophylactic agents in patients categorized as high-risk, there are few studies comparing the efficacies of ondansetron, ramosetron, and palonosetron. The aim of present study was to compare the prophylactic antiemetic efficacies of three 5HT3 receptor antagonists in high-risk patients after laparoscopic surgery. Methods In this prospective, randomized, double-blinded trial, 109 female nonsmokers scheduled for elective laparoscopic surgery were randomized to receive intravenous 4 mg ondansetron (n = 35), 0.3 mg ramosetron (n = 38), or 75 µg palonosetron (n = 36) before anesthesia. Fentanyl-based intravenous patient-controlled analgesia was administered for 48 h after surgery. Primary antiemetic efficacy variables were the incidence and severity of nausea, the frequency of emetic episodes during the first 48 h after surgery, and the need to use a rescue antiemetic medication. Results The overall incidence of nausea/retching/vomiting was lower in the palonosetron (22.2%/11.1%/5.6%) than in the ondansetron (77.1%/48.6%/28.6%) and ramosetron (60.5%/28.9%/18.4%) groups. The rescue antiemetic therapy was required less frequently in the palonosetron group than the other groups (P < 0.001). Kaplan-Meier analysis showed that the order of prophylactic efficacy in delaying the interval to use of a rescue emetic was palonosetron, ramosetron, and ondansetron. Conclusions Single-dose palonosetron is the prophylactic antiemetics of choice in high-risk patients undergoing laparoscopic surgery. PMID:23814652

  7. [Efficacy, safety and comfort of compression therapy models in the immediate post-operative period after a greater saphenectomy. A prospective randomised study].

    PubMed

    Collazo Chao, Eliseo; Luque, María Antonia; González-Ripoll, Carmen

    2010-10-01

    There is still controversy on the best compression therapy after performing a greater saphenectomy. The purpose of this study is to establish whether the use of a controlled compression stocking has the same level of safety and efficacy as a compression bandage in the immediate post-operative period after a greater saphenectomy. A prospective, randomised, open-labelled study, comparing three groups: a) a conventional compression bandage for one week, b) a conventional compression bandage replaced by a controlled tubular compression stocking at 5h of its putting in place, c) immediate direct use of the controlled tubular compression stocking, was conducted on fifty-five consecutive outpatients with a greater saphenectomy in one of their legs, and who fulfilled the inclusion criteria. The working hypothesis was that the controlled tubular compression stocking could replace, in terms of efficacy, safety and comfort, the usual controlled compression in the immediate post-operative period after saphenous vein stripping. The analysis variables were pain, control of bleeding, analgesics in the post-operative period, bruising, incapacity during the first week after the operation and comfort level. There were no statistically significant differences found between the three types of compressions studied as regards, safety, efficacy, comfort level, pain and analgesic consumption, but there was as regards the level of convenience in favour of the use of the stocking. The controlled tubular compression stocking can replace the compression bandage with more advantages after greater saphenous vein stripping in outpatients, having the same safety and efficacy. Copyright © 2009 AEC. Published by Elsevier Espana. All rights reserved.

  8. Efficacy and safety of Wilate in paediatric VWD patients under 6 years of age - results of a prospective multicentre clinical study including recovery information.

    PubMed

    Nowak-Göttl, U; Krümpel, A; Russo, A; Jansen, M

    2013-11-01

    Treatment with exogenous von Willebrand factor (VWF) is indicated in patients with von Willebrand disease (VWD) in whom treatment with 1-deamino-8-d-arginine vasopressin/desmopressin is contraindicated. Wilate is a new generation plasma-derived concentrate of native VWF and coagulation factor VIII (FVIII) (in a physiological 1:1 ratio) developed for the treatment of VWD. This is the first study to report safety, efficacy and in vivo recovery (IVR) data from 15 paediatric patients less than 6 years of age who received Wilate for either prophylaxis, on-demand treatment or for treatment in surgical procedures during a prospective open-label trial (VWD type 1: 5, type 2A: 1, type 2B: 2, type 3: 6, unknown type: 1 patients). Analysis of IVR for VWF and FVIII suggested an appropriate and consistent rise in coagulation activity after Wilate administration. Overall efficacy was rated as excellent or good for 99.7% [prophylactic infusions] and 100% [bleeding episodes/surgical procedures]. More than 82% of bleeding episodes resolved after 1 day of treatment, and a Wilate dosage of 20-50 IU kg(-1) was sufficient to achieve haemostasis in 97% of bleeding episodes. All surgical procedures were successfully managed with Wilate. No thromboembolic events were observed during the study, and no patient developed anti-VWF antibodies or FVIII inhibitors. In conclusion, this study confirms both the expected IVR profile in paediatric patients and the excellent efficacy, tolerability and safety profile of Wilate observed previously in adults. Wilate showed excellent efficacy in the treatment of bleeding when used prophylactically or on-demand, and in the treatment of surgical procedures. © 2013 John Wiley & Sons Ltd.

  9. Long-term prospective evaluation of intestinal anastomosis using stainless steel staples in 14 dogs.

    PubMed

    Benlloch-Gonzalez, Manuel; Gomes, Eymeric; Bouvy, Bernard; Poncet, Cyrill

    2015-07-01

    This prospective clinical study evaluated the use, complications, and clinical and ultrasonographic follow-ups of end-to-end intestinal anastomoses with skin staples in naturally occurring diseases in canine small and large intestines. Intestinal anastomoses were performed in 14 dogs and pre-, peri-, and postoperative data were recorded. Postoperative clinical and ultrasound evaluations were performed at regular intervals for 1 year. The mean time taken to construct the anastomosis was 5 min. There were no intraoperative complications. Hemorrhage and colonic stricture were the main postoperative complications. Staple loss occurred in 2 cases. Absence of wall layering and focal wall thickening were observed in all cases at each ultrasonographic follow-up. Hyperechoic fat was observed in all but 1 of the cases at month 1. Nine dogs were alive with normal digestive function at the end of the study. The skin stapler technique enabled rapid construction of consistent anastomoses with inexpensive stapling material.

  10. Psychosocial characteristics of candidates for the prospective evaluation of radial keratotomy (PERK) study.

    PubMed

    Bourque, L B; Rubenstein, R; Cosand, B; Waring, G O; Moffitt, S; Gelender, H; Laibson, P R; Lindstrom, R L; McDonald, M; Myers, W D

    1984-08-01

    The National Eye Institute Prospective Evaluation of Radial Keratotomy (PERK) Study is a multicenter clinical trial for the evaluation of radial keratotomy. This article describes the questionnaire data collected on PERK patients and compares them with a similar group of myopic persons studied during the Rand Health Insurance Experiment (heretofore referred to as the Rand study). The PERK patients are young, white myopes who dislike being dependent on corrective lenses but perceive themselves to be more visually impaired than do comparable Rand study myopes. Most female subjects and a plurality of the male subjects have tried contact lenses and quit wearing them mainly because use of the lenses was inconvenient or bothersome. There is no evidence that patients are psychologically or socially deviant. Both male and female subjects expressed a fear of being without vision and cited impatience with the lenses as their major motivation for wanting surgery.

  11. Long-term prospective evaluation of intestinal anastomosis using stainless steel staples in 14 dogs

    PubMed Central

    Benlloch-Gonzalez, Manuel; Gomes, Eymeric; Bouvy, Bernard; Poncet, Cyrill

    2015-01-01

    This prospective clinical study evaluated the use, complications, and clinical and ultrasonographic follow-ups of end-to-end intestinal anastomoses with skin staples in naturally occurring diseases in canine small and large intestines. Intestinal anastomoses were performed in 14 dogs and pre-, peri-, and postoperative data were recorded. Postoperative clinical and ultrasound evaluations were performed at regular intervals for 1 year. The mean time taken to construct the anastomosis was 5 min. There were no intraoperative complications. Hemorrhage and colonic stricture were the main postoperative complications. Staple loss occurred in 2 cases. Absence of wall layering and focal wall thickening were observed in all cases at each ultrasonographic follow-up. Hyperechoic fat was observed in all but 1 of the cases at month 1. Nine dogs were alive with normal digestive function at the end of the study. The skin stapler technique enabled rapid construction of consistent anastomoses with inexpensive stapling material. PMID:26130833

  12. [Evaluation of the efficacy and safety of mepifylline in oral solution in children with mild and moderate asthmatic crises].

    PubMed

    Sienra Monge, J J; Prieto Ursúa, L; Gerardo Sol Monterrey, E; Estela del Río Navarro, B; Paredes Novelo, M C

    1994-01-01

    Efficacy and safety of mepiphylline, a derivative of theophylline, was evaluated in a group of children, aged 6 to 10 years, with mild or moderate acute asthma. A parallel, randomized, double-blind, placebo controlled, prospective study was performed in 40 children. Twenty one of them received mepiphylline in dose of 8 mg/kg/día divided in 3 during 10 days, and 19 (control group) received placebo. Salbutamol aerosols were available in both groups. Clinical and spirometric data were collected before the beginning of the treatment (pre-and-post-nebulized salbutamol), and at the 3rd, 7th and 10th days. Children and parents cooperated with a diary of symptoms, peak-flow measurements and account of salbutamol used. A total relief of symptoms was found in 14 patients in the mepiphylline group and just 8 of the control group, with no significant differences. Neither spirometry nor diary data showed significant differences. Salbutamol was less than 3 days of unnecessary in 13 patients (61.9%) in the mepiphylline group and 8 patients (42.1%) in the control group (p < 0.05; Kolmogorov-Smirnov two samples Test). We conclude that mepiphylline could be a complementary treatment of mild and moderate acute asthma with a good safety in children.

  13. Effects of individualized bone density feedback and educational interventions on osteoporosis knowledge and self-efficacy: a 12-yr prospective study.

    PubMed

    Wu, Feitong; Laslett, Laura L; Wills, Karen; Oldenburg, Brian; Jones, Graeme; Winzenberg, Tania

    2014-01-01

    This is 12-yr follow-up of a randomized controlled trial aimed to evaluate the long-term effects of bone density feedback and osteoporosis education on osteoporosis knowledge and self-efficacy. We examined the effects of feedback of bone density-defined fracture risk (high [T-score <0] vs normal [T-score ≥0] risk) and 2 different educational interventions (the group-based Osteoporosis Prevention and Self-Management Course [OPSMC] vs an osteoporosis leaflet) on osteoporosis knowledge and self-efficacy in women aged 25-44. Seventy-four percent (N = 347) of 470 participants at baseline participated at 12 yr. Overall, the scores were higher for osteoporosis knowledge but lower for self-efficacy at 12 yr. However, neither intervention had an effect on the change in knowledge (T-score, β = 0.4, 95% confidence interval [CI] = -0.3 to 1.1; OPSMC, β = 0.2, 95% CI = -0.5 to 0.9) or self-efficacy (T-score, β = -1.1, 95% CI = -2.5 to 0.4; OPSMC, β = -0.2, 95% CI = -1.6 to 1.3). Women in households with an unemployed main financial provider had a decrease in knowledge at 12 yr compared with those in households with an employed main financial provider in whom knowledge increased (β = -1.95, 95% CI = -3.40 to -0.50), but there were no other predictors of change identified for knowledge or self-efficacy. In conclusion, beneficial effects of both OPSMC and feedback of high fracture risk on osteoporosis knowledge seen previously at 2 yr were not sustained after 12 yr although overall knowledge was still significantly higher than at baseline. Neither intervention improved osteoporosis self-efficacy. More frequent osteoporosis education and bone density feedback may be required to maintain knowledge, and other approaches to improve self-efficacy are necessary.

  14. Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study.

    PubMed

    Jost, Wolfgang H; Hefter, Harald; Reissig, Andrea; Kollewe, Katja; Wissel, Joerg

    2014-02-15

    The current practice in Germany and Austria, and the safety and efficacy of botulinum toxin type A (BoNT-A; Dysport) in the treatment of patients with post-stroke arm spasticity (with no fixed upper-limb contractures), were assessed in this observational prospective non-interventional study. One treatment cycle was documented with assessments at baseline, approximately week 4 (optional), and approximately week 12. Pattern of spasticity, treatment goal, safety and efficacy were recorded. Overall response and goal achievement was rated on a 4-point scale ('no goal achievement', 'goal achievement', 'good goal achievement', 'best goal achievement'). In total, 409 patients were included and 99% assigned to one of five arm-spasticity patterns. Therapy goals included reduced muscle tone (92.6%), physiotherapy or occupational therapy support (63.8%), increased range of motion (61.8%), pain reduction (58.9%), facilitation of care or hygiene (55.7%), and functional improvement (17.0%). Goals were achieved in 84% of patients. The following factors had the most potential as predictors of treatment outcome: pre-treatment; time since onset of spasticity; pattern of arm spasticity. Mean Dysport dose was 728 U and an inverse dose-response relationship was observed. Treatment was well tolerated. 500-1000 U was a safe and effective treatment for post-stroke arm spasticity in this post-marketing evaluation. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

  15. Efficacy and tolerance of repeated oral doses of tolperisone hydrochloride in the treatment of painful reflex muscle spasm: results of a prospective placebo-controlled double-blind trial.

    PubMed

    Pratzel, H G; Alken, R G; Ramm, S

    1996-10-01

    The efficacy and safety of oral tolperisone hydrochloride (Mydocalm) in the treatment of painful reflex muscle spasm was assessed in a prospective, randomized, double-blind, placebo-controlled trial. A total of 138 patients, aged between 20 and 75 years, with painful reflex muscle spasm associated with diseases of the spinal column or proximal joints were enrolled in eight rehabilitation centers. Patients were randomized to receive either 300 mg tolperisone hydrochloride or placebo for a period of 21 days. Both treatment groups recovered during the 3 weeks rehabilitation program. However, tolperisone hydrochloride proved to be significantly superior to placebo: the change score of the pressure pain threshold as the primary target parameter significantly increased during therapy with tolperisone hydrochloride (P = 0.03, valid-case-analysis) compared to the results obtained on placebo treatment. The overall assessment of efficacy by the patient also demonstrated significant differences in favor of tolperisone hydrochloride. Best results were seen in patients aged between 40 and 60 years with a history of complaints shorter than 1 year and with concomitant physical therapy. The evaluation of safety data, i.e., adverse events, biochemical and hematological laboratory parameters, demonstrated no differences between tolperisone hydrochloride and placebo. As a conclusion tolperisone hydrochloride represents an effective and safe treatment of painful reflex muscle spasm without the typical side effects of centrally active muscle relaxants.

  16. Day-Case Holmium Laser Enucleation of the Prostate: Prospective Evaluation of 90 Consecutive Cases.

    PubMed

    Comat, Vincent; Marquette, Thibault; Sutter, Willy; Bernhard, Jean-Christophe; Pasticier, Gilles; Capon, Gregoire; Bensadoun, Henri; Ferrière, Jean-Marie; Robert, Gregoire

    2017-09-28

    To prospectively assess the feasibility and safety of holmium laser enucleation of the prostate (HoLEP) as day-case surgery for the treatment of benign prostatic hyperplasia. A prospective observational study was conducted by a single surgeon between June 2012 and October 2015. Except for patients ineligible for day-case surgery due to unstable cardiovascular disease, all patients with lower urinary tract symptoms presumably due to benign prostatic hyperplasia were consecutively included. HoLEP procedures were performed at 8AM, and patients were discharged before 8PM. The urinary catheter was removed at home the following morning. The monitoring of complications related with surgery included systematic assessment of perioperative complications, phone call within 48 hours after surgery, and follow-up visits after 1 and 3 months. Intent-to-treat univariate and multivariate analysis was performed to identify risk factors for day-case surgery failure. Ninety among 211 HoLEP performed by the surgeon were selected for day-case surgery (43%). Hospital stay was <12 hours in 83.4% of them. Prolonged hospitalization was necessary in 15 patients mainly due to gross hematuria requiring continuous bladder irrigation (n = 13). Day-case surgery failure rate (including prolonged hospitalization and readmissions within 48 hours) was 20.0% (18/90). The overall complication rate was 36.7%, with a Clavien III complication rate of only 3.3%. Monocentric design and limited number of patients are the main limitations of this work. This prospective evaluation shows that day-case HoLEP may be performed by a trained surgeon with an appropriate patient selection.

  17. Efficacy of pedobarographic analysis to evaluate proximal medial gastrocnemius recession in patients with gastrocnemius tightness and metatarsalgia.

    PubMed

    Vinagre, Gustavo; Alfonso, Matías; Cruz-Morande, Sebastián; Hernández, Miguel; Villas, Carlos

    2017-08-31

    Proximal medial gastrocnemius recession (PMGR) is a surgical procedure performed in patients with gastrocnemius tightness (GT). The purpose of this study is to evaluate the efficacy of pedobarographic analysis on PMGR in patients with GT and metatarsalgia. This prospective study included 52 patients diagnosed with GT treated surgically with PMGR and 49 non-operated upon patients (control group). A total of 55 PMGRs (three bilateral) were performed as an isolated or combined procedure in the treatment group. Passive ankle dorsiflexion with knee flexion and extension was evaluated in all patients. In addition, pedobarographic analysis was performed before and after surgery. Median preoperative ankle dorsiflexion was -10.0° (equinus) with extended knee and 10.0° with flexed knee and postoperative differences in median ankle dorsiflexion was 12.5° (extended knee) (p = 0.000) and 5.0° (flexed knee) (p = 0.002). After the PMGR, the median area of the contact surface (-3.0 cm(2)) (p = 0.009), the maximum (-13,239.0 Pa) (p = 0.019) and mean pressure (-2,942.0 Pa) and the forefoot force (-70.0 N) (p = 0.000) decreased. An increase in hindfoot force (20.0 N), hindfoot bearing time (4.0 ms) (p = 0.005), and forefoot bearing time (1.0 ms) was also observed. Pedobarographic analysis is an efficient tool to evaluate surgical procedures that assess metatarsal overload. PMGR is an effective surgical procedure to improve passive ankle range of motion and decrease forefoot plantar overload.

  18. Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study.

    PubMed

    Vanlangenhove, Peter; De Keukeleire, Katrien; Everaert, Karel; Van Maele, Georges; Defreyne, Luc

    2012-06-01

    This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. A total of 112 insufficient spermatic veins (left-sided, n=84; right-sided, n=28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n=54; Histoacryl, Braun, Germany) or NBCA-MS (n=58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n=54/54, 100% vs. NBCA-MS, n=54/57, 94.7%; P=0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n=45/54, 83.3% vs. NBCA-MS, n=41/58, 70.7%; P=0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n=25/54, 46.3% vs. NBCA-MS, n=29/58, 50%; P=0.71). No glue-related complications were noted. NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

  19. Efficacy and Safety of Two Different n-Butyl-2-Cyanoacrylates for the Embolization of Varicoceles: A Prospective, Randomized, Blinded Study

    SciTech Connect

    Vanlangenhove, Peter Keukeleire, Katrien De; Everaert, Karel; Maele, Georges Van; Defreyne, Luc

    2012-06-15

    Purpose: This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. Methods: A total of 112 insufficient spermatic veins (left-sided, n = 84; right-sided, n = 28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n = 54; Histoacryl, Braun, Germany) or NBCA-MS (n = 58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Results: Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n = 54/54, 100% vs. NBCA-MS, n = 54/57, 94.7%; P = 0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n = 45/54, 83.3% vs. NBCA-MS, n = 41/58, 70.7%; P = 0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n = 25/54, 46.3% vs. NBCA-MS, n = 29/58, 50%; P = 0.71). No glue-related complications were noted. Conclusions: NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

  20. Prospective and retrospective evaluation of five-year earthquake forecast models for California

    NASA Astrophysics Data System (ADS)

    Strader, Anne; Schneider, Max; Schorlemmer, Danijel

    2017-10-01

    The Collaboratory for the Study of Earthquake Predictability was developed to prospectively test earthquake forecasts through reproducible and transparent experiments within a controlled environment. From January 2006 to December 2010, the Regional Earthquake Likelihood Models (RELM) Working Group developed and evaluated thirteen time-invariant prospective earthquake mainshock forecasts. The number, spatial and magnitude components of the forecasts were compared to the observed seismicity distribution using a set of likelihood-based consistency tests. In this RELM experiment update, we assess the long-term forecasting potential of the RELM forecasts. Additionally, we evaluate RELM forecast performance against the Uniform California Earthquake Rupture Forecast (UCERF2) and the National Seismic Hazard Mapping Project (NSHMP) forecasts, which are used for seismic hazard analysis for California. To test each forecast's long-term stability, we also evaluate each forecast from January 2006 to December 2015, which contains both five-year testing periods, and the 40-year period from January 1967 to December 2006. Multiple RELM forecasts, which passed the N-test during the retrospective (January 2006 to December 2010) period, overestimate the number of events from January 2011 to December 2015, although their forecasted spatial distributions are consistent with observed earthquakes. Both the UCERF2 and NSHMP forecasts pass all consistency tests for the two five-year periods; however, they tend to underestimate the number of observed earthquakes over the 40-year testing period. The smoothed seismicity model Helmstetter-et-al.Mainshock outperforms both United States Geological Survey (USGS) models during the second five-year experiment